CFR 2017 Title42a Vol5

Title 42
Public Health
Part 482 to End
Revised as of October 1, 2017
Containing a codification of documents

of general applicability and future effect
As of October 1, 2017
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
kpayne on DSK54DXVN1OFR with $$_JOB
VerDate Sep<11>2014 16:14 Nov 29, 2017 Jkt 241196 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Q:\42\42V5.TXT 31
U.S. GOVERNMENT OFFICIAL EDITION NOTICE
Legal Status and Use of Seals and Logos

The seal of the National Archives and Records Administration
(NARA) authenticates the Code of Federal Regulations (CFR) as
the official codification of Federal regulations established under
the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the
contents of the CFR, a special edition of the Federal Register, shall
be judicially noticed. The CFR is prima facie evidence of the origi-
nal documents published in the Federal Register (44 U.S.C. 1510).
It is prohibited to use NARA’s official seal and the stylized Code
of Federal Regulations logo on any republication of this material
without the express, written permission of the Archivist of the
United States or the Archivist’s designee. Any person using
NARA’s official seals and logos in a manner inconsistent with the
provisions of 36 CFR part 1200 is subject to the penalties specified
in 18 U.S.C. 506, 701, and 1017.
Use of ISBN Prefix

This is the Official U.S. Government edition of this publication
and is herein identified to certify its authenticity. Use of the 0–16
ISBN prefix is for U.S. Government Publishing Office Official Edi-
tions only. The Superintendent of Documents of the U.S. Govern-
ment Publishing Office requests that any reprinted edition clearly
be labeled as a copy of the authentic work with a new ISBN.
U.S. GOVERNMENT PUBLISHING OFFICE
U.S. Superintendent of Documents • Washington, DC 20402–0001

http://bookstore.gpo.gov
gpologo2.eps</GPH>
Phone: toll-free (866) 512-1800; DC area (202) 512-1800

archives.ai</GPH>
Table of Contents
Page
Explanation ................................................................................................ v
Title 42:
Chapter IV—Centers for Medicare & Medicaid Services, Depart-

ment of Health and Human Services (Continued) ........................ 3
Chapter V—Office of Inspector General-Health Care, Department

of Health and Human Services .................................................... 981
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 1095
Alphabetical List of Agencies Appearing in the CFR ......................... 1115
List of CFR Sections Affected ............................................................. 1125

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 42 CFR 482.1
refers to title 42, part
482, section 1.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially noticed (44
U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text
of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual issues
of the Federal Register. These two publications must be used together to deter-
mine the latest version of any given rule.
To determine whether a Code volume has been amended since its revision date
(in this case, October 1, 2017), consult the ‘‘List of CFR Sections Affected (LSA),’’
which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which
appears in the Reader Aids section of the daily Federal Register. These two lists
will identify the Federal Register page number of the latest amendment of any
given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal Reg-
ister since the last revision of that volume of the Code. Source citations for
the regulations are referred to by volume number and page number of the Federal
Register and date of publication. Publication dates and effective dates are usu-
ally not the same and care must be exercised by the user in determining the
actual effective date. In instances where the effective date is beyond the cut-
off date for the Code a note has been inserted to reflect the future effective
date. In those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be inserted following
the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies
to display an OMB control number with their information collection request.
Many agencies have begun publishing numerous OMB control numbers as amend-
ments to existing regulations in the CFR. These OMB numbers are placed as
close as possible to the applicable recordkeeping or reporting requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of the revision
date stated on the cover of each volume are not carried. Code users may find
the text of provisions in effect on any given date in the past by using the appro-
priate List of CFR Sections Affected (LSA). For the convenience of the reader,
a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume.
For changes to the Code prior to the LSA listings at the end of the volume,
consult previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published for 1949-
1963, 1964-1972, 1973-1985, and 1986-2000.
‘‘[RESERVED]’’ TERMINOLOGY
The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal
Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ loca-
tion at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that
a portion of the CFR was left vacant and not accidentally dropped due to a print-
ing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was established
by statute and allows Federal agencies to meet the requirement to publish regu-
lations in the Federal Register by referring to materials already published else-
where. For an incorporation to be valid, the Director of the Federal Register
must approve it. The legal effect of incorporation by reference is that the mate-
rial is treated as if it were published in full in the Federal Register (5 U.S.C.
552(a)). This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the Federal Register
will approve an incorporation by reference only when the requirements of 1 CFR
part 51 are met. Some of the elements on which approval is based are:
(a) The incorporation will substantially reduce the volume of material pub-
lished in the Federal Register.
(b) The matter incorporated is in fact available to the extent necessary to
afford fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for publication in
accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If you have any
problem locating or obtaining a copy of material listed as an approved incorpora-
tion by reference, please contact the agency that issued the regulation containing
that incorporation. If, after contacting the agency, you find the material is not
available, please notify the Director of the Federal Register, National Archives
and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or
call 202-741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a separate
volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS.
This volume contains the Parallel Table of Authorities and Rules. A list of CFR
titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-
lishing in the CFR are also included in this volume.
vi
An index to the text of ‘‘Title 3—The President’’ is carried within that volume.
The Federal Register Index is issued monthly in cumulative form. This index
is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg-
ister.
A List of CFR Sections Affected (LSA) is published monthly, keyed to the
revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing in the
Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this volume,
contact the issuing agency. The issuing agency’s name appears at the top of
odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202–741–6000 or write
to the Director, Office of the Federal Register, National Archives and Records
Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail
fedreg.info@nara.gov.
SALES
The Government Publishing Office (GPO) processes all sales and distribution
of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area,
202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours
a day. For payment by check, write to: US Government Publishing Office – New
Orders, P.O. Box 979050, St. Louis, MO 63197-9000.
ELECTRONIC SERVICES
The full text of the Code of Federal Regulations, the LSA (List of CFR Sections
Affected), The United States Government Manual, the Federal Register, Public
Laws, Public Papers of the Presidents of the United States, Compilation of Presi-
dential Documents and the Privacy Act Compilation are available in electronic
format via www.ofr.gov. For more information, contact the GPO Customer Con-
tact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-
1800 (toll-free). E-mail, ContactCenter@gpo.gov.
The Office of the Federal Register also offers a free service on the National
Archives and Records Administration’s (NARA) World Wide Web site for public
law numbers, Federal Register finding aids, and related information. Connect
to NARA’s web site at www.archives.gov/federal-register.
The e-CFR is a regularly updated, unofficial editorial compilation of CFR ma-
terial and Federal Register amendments, produced by the Office of the Federal
Register and the Government Publishing Office. It is available at www.ecfr.gov.
OLIVER A. POTTS,
Director,
Office of the Federal Register.
October 1, 2017.
vii
THIS TITLE
Title 42—PUBLIC HEALTH is composed of five volumes. The parts in these vol-
umes are arranged in the following order: Parts 1–399, parts 400–413, parts 414–
429, parts 430 to 481, and part 482 to end. The first volume (parts 1–399) contains
current regulations issued under chapter I—Public Health Service (HHS). The
second, third, and fourth volumes (parts 400–413, parts 414–429, and parts 430 to
481) include regulations issued under chapter IV—Centers for Medicare & Med-
icaid Services (HHS) and the fifth volume (part 482 to end) contains the remaining
regulations in chapter IV and the regulations issued under chapter V by the Of-
fice of Inspector General-Health Care (HHS). The contents of these volumes rep-
resent all current regulations codified under this title of the CFR as of October
1, 2017.
For this volume, Gabrielle E. Burns was Chief Editor. The Code of Federal
Regulations publication program is under the direction of John Hyrum Martinez,
assisted by Stephen J. Frattini.
ix
Title 42—Public Health
(This book contains part 482 to End)
Part
CHAPTER IV—Centers for Medicare & Medicaid Services, De-

partment of Health and Human Services (Continued) ....... 482
CHAPTER V—Office of Inspector General-Health Care, De-
partment of Health and Human Services ........................... 1000
CHAPTER IV—CENTERS FOR MEDICARE &
MEDICAID SERVICES, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
EDITORIAL NOTE: Nomenclature changes to chapter IV appear at 66 FR 39452, July 31, 2001,
67 FR 36540, May 24, 2002, 69 FR 18803, Apr. 9, 2004, and 77 FR 29028, May 16, 2012.
SUBCHAPTER G—STANDARDS AND CERTIFICATION
Part Page
482 Conditions of participation for hospitals ................ 5
483 Requirements for States and long term care facili-
ties ....................................................................... 48
484 Home health services .............................................. 149
485 Conditions of participation: Specialized providers 192
486 Conditions for coverage of specialized services fur-
nished by suppliers ............................................... 242
488 Survey, certification, and enforcement procedures 264
489 Provider agreements and supplier approval ............ 572
491 Certification of certain health facilities ................. 606
493 Laboratory requirements ........................................ 613
494 Conditions for coverage for end-stage renal disease
facilities ............................................................... 735
495 Standards for the Electronic Health Record Tech-
nology Incentive Program .................................... 754
498 Appeals procedures for determinations that affect
participation in the Medicare program and for
determinations that affect the participation of
ICFs/IID and certain NFs in the Medicaid pro-
gram ..................................................................... 848
SUBCHAPTER H—HEALTH CARE INFRASTRUCTURE AND MODEL
PROGRAMS
505 Establishment of the health care infrastructure

improvement program .......................................... 867
510 Comprehensive care for joint replacement model ... 870
42 CFR Ch. IV (10–1–17 Edition)
Part Page
512 Episode payment model .......................................... 910
SUBCHAPTER I—BASIC HEALTH PROGRAM
600 Administration, eligibility, essential health bene-

fits, performance standards, service delivery re-
quirements, premium and cost sharing, allot-
ments, and reconciliation .................................... 961
601–699 [Reserved]
SUBCHAPTER G—STANDARDS AND CERTIFICATION
PART 482—CONDITIONS OF 482.56 Condition of participation: Rehabili-

tation services.
PARTICIPATION FOR HOSPITALS 482.57 Condition of participation: Res-
piratory care services.
Subpart A—General Provisions 482.58 Special requirements for hospital pro-
viders of long-term care services
Sec. (‘‘swing-beds’’).
482.1 Basis and scope.
482.2 Provision of emergency services by Subpart E—Requirements for Specialty
nonparticipating hospitals. Hospitals
Subpart B—Administration 482.60 Special provisions applying to psy-
chiatric hospitals.
482.11 Condition of participation: Compli- 482.61 Condition of participation: Special
ance with Federal, State and local laws. medical record requirements for psy-
482.12 Condition of participation: Governing chiatric hospitals.
body. 482.62 Condition of participation: Special
482.13 Condition of participation: Patient’s staff requirements for psychiatric hos-
rights. pitals.
482.15 Condition of participation: Emer- 482.68 Special requirements for transplant
gency preparedness. centers.
482.70 Definitions.
Subpart C—Basic Hospital Functions
GENERAL REQUIREMENTS FOR TRANSPLANT
482.21 Condition of participation: Quality CENTERS
assessment and performance improve-
ment program. 482.72 Condition of participation: OPTN
482.22 Condition of participation: Medical Membership.
staff. 482.74 Condition of participation: Notifica-
482.23 Condition of participation: Nursing tion to CMS.
services. 482.76 Condition of participation: Pediatric
482.24 Condition of participation: Medical Transplants.
record services. 482.78 Condition of participation: Emer-
482.25 Condition of participation: Pharma- gency preparedness for transplant cen-
ceutical services. ters.
482.26 Condition of participation: TRANSPLANT CENTER DATA SUBMISSION, CLIN-
Radiologic services. ICAL EXPERIENCE, AND OUTCOME REQUIRE-
482.27 Condition of participation: Labora- MENTS
tory services.
482.28 Condition of participation: Food and 482.80 Condition of participation: Data sub-
dietetic services. mission, clinical experience, and out-
482.30 Condition of participation: Utiliza- come requirements for initial approval of
tion review. transplant centers.
482.41 Condition of participation: Physical 482.82 Condition of participation: Data sub-
environment. mission, clinical experience, and out-
482.42 Condition of participation: Infection come requirements for re-approval of
control. transplant centers.
482.43 Condition of participation: Discharge
TRANSPLANT CENTER PROCESS REQUIREMENTS
planning.
482.45 Condition of participation: Organ, tis- 482.90 Condition of participation: Patient
sue, and eye procurement. and living donor selection.
482.92 Condition of participation: Organ re-
Subpart D—Optional Hospital Services covery and receipt.
482.94 Condition of participation: Patient
482.51 Condition of participation: Surgical and living donor management.
services. 482.96 Condition of participation: Quality
482.52 Condition of participation: Anes- assessment and performance improve-
thesia services. ment (QAPI).
482.53 Condition of participation: Nuclear 482.98 Condition of participation: Human re-
medicine services. sources.
482.54 Condition of participation: Out- 482.100 Condition of participation: Organ

patient services. procurement.
482.55 Condition of participation: Emer- 482.102 Condition of participation: Patient
gency services. and living donor rights.
§ 482.1 42 CFR Ch. IV (10–1–17 Edition)
482.104 Condition of participation: Addi- hospital services. Regulations inter-
tional requirements for kidney trans- preting those provisions specify that
plant centers. hospitals receiving payment under
AUTHORITY: Secs. 1102, 1871 and 1881 of the Medicaid must meet the requirements
Social Security Act (42 U.S.C. 1302, 1395hh, for participation in Medicare (except in
and 1395rr), unless otherwise noted. the case of medical supervision of
SOURCE: 51 FR 22042, June 17, 1986, unless nurse-midwife services. See §§ 440.10 and
otherwise noted. 440.165 of this chapter.).
(b) Scope. Except as provided in sub-
Subpart A—General Provisions part A of part 488 of this chapter, the
provisions of this part serve as the
§ 482.1 Basis and scope. basis of survey activities for the pur-
(a) Statutory basis. (1) Section 1861(e) pose of determining whether a hospital
of the Act provides that— qualifies for a provider agreement
(i) Hospitals participating in Medi- under Medicare and Medicaid.
care must meet certain specified re- [51 FR 22042, June 17, 1986, as amended at 60
quirements; and FR 50442, Sept. 29, 1995]
(ii) The Secretary may impose addi-
tional requirements if they are found § 482.2 Provision of emergency serv-
necessary in the interest of the health ices by nonparticipating hospitals.
and safety of the individuals who are (a) The services of an institution that
furnished services in hospitals. does not have an agreement to partici-
(2) Section 1861(f) of the Act provides pate in the Medicare program may,
that an institution participating in nevertheless, be reimbursed under the
Medicare as a psychiatric hospital program if—
must meet certain specified require- (1) The services are emergency serv-
ments imposed on hospitals under sec- ices; and
tion 1861(e), must be primarily engaged (2) The institution meets the require-
in providing, by or under the super- ments of section 1861(e) (1) through (5)
vision of a physician, psychiatric serv- and (7) of the Act. Rules applicable to
ices for the diagnosis and treatment of emergency services furnished by non-
mentally ill persons, must maintain participating hospitals are set forth in
clinical records and other records that subpart G of part 424 of this chapter.
the Secretary finds necessary, and (b) Section 440.170(e) of this chapter
must meet staffing requirements that defines emergency hospital services for
the Secretary finds necessary to carry purposes of Medicaid reimbursement.
out an active program of treatment for
individuals who are furnished services [51 FR 22042, June 17, 1986, as amended at 53
in the hospital. A distinct part of an FR 6648, Mar. 2, 1988]
institution can participate as a psy-
chiatric hospital if the institution Subpart B—Administration
meets the specified 1861(e) require-
ments and is primarily engaged in pro- § 482.11 Condition of participation:
viding psychiatric services, and if the Compliance with Federal, State and
local laws.
distinct part meets the records and
staffing requirements that the Sec- (a) The hospital must be in compli-
retary finds necessary. ance with applicable Federal laws re-
(3) Sections 1861(k) and 1902(a)(30) of lated to the health and safety of pa-
the Act provide that hospitals partici- tients.
pating in Medicare and Medicaid must (b) The hospital must be—
have a utilization review plan that (1) Licensed; or
meets specified requirements. (2) Approved as meeting standards for
(4) Section 1883 of the Act sets forth licensing established by the agency of
the requirements for hospitals that the State or locality responsible for li-
provide long term care under an agree- censing hospitals.
ment with the Secretary. (c) The hospital must assure that
(5) Section 1905(a) of the Act provides personnel are licensed or meet other
that ‘‘medical assistance’’ (Medicaid) applicable standards that are required
payments may be applied to various by State or local laws.
Centers for Medicare & Medicaid Services, HHS § 482.12
§ 482.12 Condition of participation: (9) Ensure that when telemedicine

Governing body. services are furnished to the hospital’s
There must be an effective governing patients through an agreement with a
body that is legally responsible for the distant-site telemedicine entity, the
conduct of the hospital. If a hospital written agreement specifies that the
does not have an organized governing distant-site telemedicine entity is a
body, the persons legally responsible contractor of services to the hospital
for the conduct of the hospital must and as such, in accordance with
carry out the functions specified in § 482.12(e), furnishes the contracted
this part that pertain to the governing services in a manner that permits the
body. hospital to comply with all applicable
(a) Standard: Medical staff. The gov- conditions of participation for the con-
erning body must: tracted services, including, but not
(1) Determine, in accordance with limited to, the requirements in para-
State law, which categories of practi- graphs (a)(1) through (a)(7) of this sec-
tioners are eligible candidates for ap- tion with regard to the distant-site
pointment to the medical staff; telemedicine entity’s physicians and
(2) Appoint members of the medical practitioners providing telemedicine
staff after considering the rec- services. The governing body of the
ommendations of the existing members hospital whose patients are receiving
of the medical staff; the telemedicine services may, in ac-
(3) Assure that the medical staff has cordance with § 482.22(a)(4) of this part,
bylaws; grant privileges to physicians and prac-
(4) Approve medical staff bylaws and titioners employed by the distant-site
other medical staff rules and regula- telemedicine entity based on such hos-
tions; pital’s medical staff recommendations;
(5) Ensure that the medical staff is such staff recommendations may rely
accountable to the governing body for on information provided by the dis-
the quality of care provided to pa- tant-site telemedicine entity.
tients; (10) Consult directly with the indi-
(6) Ensure the criteria for selection vidual assigned the responsibility for
are individual character, competence, the organization and conduct of the
training, experience, and judgment; hospital’s medical staff, or his or her
and
designee. At a minimum, this direct
(7) Ensure that under no cir-
consultation must occur periodically
cumstances is the accordance of staff
throughout the fiscal or calendar year
membership or professional privileges
and include discussion of matters re-
in the hospital dependent solely upon
lated to the quality of medical care
certification, fellowship, or member-
provided to patients of the hospital.
ship in a specialty body or society.
(8) Ensure that, when telemedicine For a multi-hospital system using a
services are furnished to the hospital’s single governing body, the single
patients through an agreement with a multi-hospital system governing body
distant-site hospital, the agreement is must consult directly with the indi-
written and that it specifies that it is vidual responsible for the organized
the responsibility of the governing medical staff (or his or her designee) of
body of the distant-site hospital to each hospital within its system in addi-
meet the requirements in paragraphs tion to the other requirements of this
(a)(1) through (a)(7) of this section with paragraph (a).
regard to the distant-site hospital’s (b) Standard: Chief executive officer.
physicians and practitioners providing The governing body must appoint a
telemedicine services. The governing chief executive officer who is respon-
body of the hospital whose patients are sible for managing the hospital.
receiving the telemedicine services (c) Standard: Care of patients. In ac-
may, in accordance with § 482.22(a)(3) of cordance with hospital policy, the gov-
this part, grant privileges based on its erning body must ensure that the fol-
medical staff recommendations that lowing requirements are met:

rely on information provided by the (1) Every Medicare patient is under
distant-site hospital. the care of:
§ 482.12 42 CFR Ch. IV (10–1–17 Edition)
(i) A doctor of medicine or osteop- (C) Limited, under paragraph (c)(1)(v)

athy (This provision is not to be con- of this section, with respect to chiro-
strued to limit the authority of a doc- practors.
tor of medicine or osteopathy to dele- (d) Standard: Institutional plan and
gate tasks to other qualified health budget. The institution must have an
care personnel to the extent recognized overall institutional plan that meets
under State law or a State’s regulatory the following conditions:
mechanism.); (1) The plan must include an annual
(ii) A doctor of dental surgery or den- operating budget that is prepared ac-
tal medicine who is legally authorized cording to generally accepted account-
to practice dentistry by the State and ing principles.
who is acting within the scope of his or (2) The budget must include all an-
her license; ticipated income and expenses. This
(iii) A doctor of podiatric medicine, provision does not require that the
but only with respect to functions budget identify item by item the com-
which he or she is legally authorized by ponents of each anticipated income or
the State to perform; expense.
(iv) A doctor of optometry who is le-
(3) The plan must provide for capital
gally authorized to practice optometry
expenditures for at least a 3-year pe-
by the State in which he or she prac-
riod, including the year in which the
tices;
operating budget specified in para-
(v) A chiropractor who is licensed by
graph (d)(2) of this section is applica-
the State or legally authorized to per-
ble.
form the services of a chiropractor, but
only with respect to treatment by (4) The plan must include and iden-
means of manual manipulation of the tify in detail the objective of, and the
spine to correct a subluxation dem- anticipated sources of financing for,
onstrated by x-ray to exist; and each anticipated capital expenditure in
(vi) A clinical psychologist as defined excess of $600,000 (or a lesser amount
in § 410.71 of this chapter, but only with that is established, in accordance with
respect to clinical psychologist serv- section 1122(g)(1) of the Act, by the
ices as defined in § 410.71 of this chapter State in which the hospital is located)
and only to the extent permitted by that relates to any of the following:
State law. (i) Acquisition of land;
(2) Patients are admitted to the hos- (ii) Improvement of land, buildings,
pital only on the recommendation of a and equipment; or
licensed practitioner permitted by the (iii) The replacement, modernization,
State to admit patients to a hospital. and expansion of buildings and equip-
If a Medicare patient is admitted by a ment.
practitioner not specified in paragraph (5) The plan must be submitted for
(c)(1) of this section, that patient is review to the planning agency des-
under the care of a doctor of medicine ignated in accordance with section
or osteopathy. 1122(b) of the Act, or if an agency is not
(3) A doctor of medicine or osteop- designated, to the appropriate health
athy is on duty or on call at all times. planning agency in the State. (See part
(4) A doctor of medicine or osteop- 100 of this title.) A capital expenditure
athy is responsible for the care of each is not subject to section 1122 review if
Medicare patient with respect to any 75 percent of the health care facility’s
medical or psychiatric problem that— patients who are expected to use the
(i) is present on admission or devel- service for which the capital expendi-
ops during hospitalization; and ture is made are individuals enrolled in
(ii) Is not specifically within the a health maintenance organization
scope of practice of a doctor of dental (HMO) or competitive medical plan
surgery, dental medicine, podiatric (CMP) that meets the requirements of
medicine, or optometry; a chiro- section 1876(b) of the Act, and if the
practor; or clinical psychologist, as Department determines that the cap-
that scope is— ital expenditure is for services and fa-

(A) Defined by the medical staff; cilities that are needed by the HMO or
(B) Permitted by State law; and CMP in order to operate efficiently and
economically and that are not other- one or more off-campus departments of
wise readily accessible to the HMO or the hospital, the governing body of the
CMP because— hospital must assure that the medical
(i) The facilities do not provide com- staff has written policies and proce-
mon services at the same site; dures in effect with respect to the off-
(ii) The facilities are not available campus department(s) for appraisal of
under a contract of reasonable dura- emergencies and referral when appro-
tion; priate.
(iii) Full and equal medical staff [51 FR 22042, June 17, 1986; 51 FR 27847, Aug.
privileges in the facilities are not 4, 1986, as amended at 53 FR 6549, Mar. 1, 1988;
available; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1,
(iv) Arrangements with these facili- 1991; 56 FR 23022, May 20, 1991; 59 FR 46514,
ties are not administratively feasible; Sept. 8, 1994; 63 FR 20130, Apr. 23, 1998; 63 FR
or 33874, June 22, 1998; 68 FR 53262, Sept. 9, 2003;
(v) The purchase of these services is 76 FR 25562, May 5, 2011; 77 FR 29074, May 16,
2012; 79 FR 27154, May 12, 2014]
more costly than if the HMO or CMP
provided the services directly. § 482.13 Condition of participation: Pa-
(6) The plan must be reviewed and up- tient’s rights.
dated annually. A hospital must protect and promote
(7) The plan must be prepared— each patient’s rights.
(i) Under the direction of the gov- (a) Standard: Notice of rights—(1) A
erning body; and hospital must inform each patient, or
(ii) By a committee consisting of rep- when appropriate, the patient’s rep-
resentatives of the governing body, the resentative (as allowed under State
administrative staff, and the medical law), of the patient’s rights, in advance
staff of the institution. of furnishing or discontinuing patient
(e) Standard: Contracted services. The care whenever possible.
governing body must be responsible for (2) The hospital must establish a
services furnished in the hospital process for prompt resolution of pa-
whether or not they are furnished tient grievances and must inform each
under contracts. The governing body patient whom to contact to file a griev-
must ensure that a contractor of serv- ance. The hospital’s governing body
ices (including one for shared services must approve and be responsible for
and joint ventures) furnishes services the effective operation of the grievance
that permit the hospital to comply process and must review and resolve
with all applicable conditions of par- grievances, unless it delegates the re-
ticipation and standards for the con- sponsibility in writing to a grievance
tracted services. committee. The grievance process
(1) The governing body must ensure must include a mechanism for timely
that the services performed under a referral of patient concerns regarding
contract are provided in a safe and ef- quality of care or premature discharge
fective manner. to the appropriate Utilization and
(2) The hospital must maintain a list Quality Control Quality Improvement
of all contracted services, including Organization. At a minimum:
the scope and nature of the services (i) The hospital must establish a
provided. clearly explained procedure for the
(f) Standard: Emergency services. (1) If submission of a patient’s written or
emergency services are provided at the verbal grievance to the hospital.
hospital, the hospital must comply (ii) The grievance process must speci-
with the requirements of § 482.55. fy time frames for review of the griev-
(2) If emergency services are not pro- ance and the provision of a response.
vided at the hospital, the governing (iii) In its resolution of the griev-
body must assure that the medical ance, the hospital must provide the pa-
staff has written policies and proce- tient with written notice of its decision
dures for appraisal of emergencies, ini- that contains the name of the hospital
tial treatment, and referral when ap- contact person, the steps taken on be-
propriate. half of the patient to investigate the

(3) If emergency services are provided grievance, the results of the grievance
at the hospital but are not provided at process, and the date of completion.
§ 482.13 42 CFR Ch. IV (10–1–17 Edition)
(b) Standard: Exercise of rights. (1) The retaliation by staff. Restraint or seclu-
patient has the right to participate in sion may only be imposed to ensure the
the development and implementation immediate physical safety of the pa-
of his or her plan of care. tient, a staff member, or others and
(2) The patient or his or her rep- must be discontinued at the earliest
resentative (as allowed under State possible time.
law) has the right to make informed (1) Definitions. (i) A restraint is—
decisions regarding his or her care. The (A) Any manual method, physical or
patient’s rights include being informed mechanical device, material, or equip-
of his or her health status, being in- ment that immobilizes or reduces the
volved in care planning and treatment, ability of a patient to move his or her
and being able to request or refuse arms, legs, body, or head freely; or
treatment. This right must not be con- (B) A drug or medication when it is
strued as a mechanism to demand the used as a restriction to manage the pa-
provision of treatment or services tient’s behavior or restrict the pa-
deemed medically unnecessary or inap- tient’s freedom of movement and is not
propriate. a standard treatment or dosage for the
(3) The patient has the right to for- patient’s condition.
mulate advance directives and to have (C) A restraint does not include de-
hospital staff and practitioners who vices, such as orthopedically prescribed
provide care in the hospital comply devices, surgical dressings or bandages,
with these directives, in accordance protective helmets, or other methods
with § 489.100 of this part (Definition), that involve the physical holding of a
§ 489.102 of this part (Requirements for patient for the purpose of conducting
providers), and § 489.104 of this part (Ef- routine physical examinations or tests,
fective dates). or to protect the patient from falling
(4) The patient has the right to have out of bed, or to permit the patient to
a family member or representative of participate in activities without the
his or her choice and his or her own risk of physical harm (this does not in-
physician notified promptly of his or clude a physical escort).
her admission to the hospital. (ii) Seclusion is the involuntary con-
(c) Standard: Privacy and safety. (1) finement of a patient alone in a room
The patient has the right to personal or area from which the patient is phys-
privacy. ically prevented from leaving. Seclu-
(2) The patient has the right to re- sion may only be used for the manage-
ceive care in a safe setting. ment of violent or self-destructive be-
(3) The patient has the right to be havior.
free from all forms of abuse or harass- (2) Restraint or seclusion may only
ment. be used when less restrictive interven-
(d) Standard: Confidentiality of patient tions have been determined to be inef-
records. (1) The patient has the right to fective to protect the patient a staff
the confidentiality of his or her clin- member or others from harm.
ical records. (3) The type or technique of restraint
(2) The patient has the right to ac- or seclusion used must be the least re-
cess information contained in his or strictive intervention that will be ef-
her clinical records within a reasonable fective to protect the patient, a staff
time frame. The hospital must not member, or others from harm.
frustrate the legitimate efforts of indi- (4) The use of restraint or seclusion
viduals to gain access to their own must be—
medical records and must actively seek (i) In accordance with a written
to meet these requests as quickly as its modification to the patient’s plan of
record keeping system permits. care; and
(e) Standard: Restraint or seclusion. All (ii) Implemented in accordance with
patients have the right to be free from safe and appropriate restraint and se-
physical or mental abuse, and corporal clusion techniques as determined by
punishment. All patients have the hospital policy in accordance with
right to be free from restraint or seclu- State law.

sion, of any form, imposed as a means (5) The use of restraint or seclusion
of coercion, discipline, convenience, or must be in accordance with the order
10
of a physician or other licensed inde- (11) Physician and other licensed

pendent practitioner who is responsible independent practitioner training re-
for the care of the patient as specified quirements must be specified in hos-
under § 482.12(c) and authorized to order pital policy. At a minimum, physicians
restraint or seclusion by hospital pol- and other licensed independent practi-
icy in accordance with State law. tioners authorized to order restraint or
(6) Orders for the use of restraint or seclusion by hospital policy in accord-
seclusion must never be written as a ance with State law must have a work-
standing order or on an as needed basis ing knowledge of hospital policy re-
(PRN). garding the use of restraint or seclu-
(7) The attending physician must be sion.
consulted as soon as possible if the at- (12) When restraint or seclusion is
tending physician did not order the re- used for the management of violent or
straint or seclusion. self-destructive behavior that jeopard-
(8) Unless superseded by State law izes the immediate physical safety of
that is more restrictive— the patient, a staff member, or others,
(i) Each order for restraint or seclu- the patient must be seen face-to-face
sion used for the management of vio- within 1 hour after the initiation of the
lent or self-destructive behavior that intervention—
jeopardizes the immediate physical (i) By a—
safety of the patient, a staff member, (A) Physician or other licensed inde-
or others may only be renewed in ac- pendent practitioner; or
cordance with the following limits for (B) Registered nurse or physician as-
up to a total of 24 hours: sistant who has been trained in accord-
ance with the requirements specified in
(A) 4 hours for adults 18 years of age
paragraph (f) of this section.
or older;
(ii) To evaluate—
(B) 2 hours for children and adoles- (A) The patient’s immediate situa-
cents 9 to 17 years of age; or tion;
(C) 1 hour for children under 9 years (B) The patient’s reaction to the
of age; and intervention;
(ii) After 24 hours, before writing a (C) The patient’s medical and behav-
new order for the use of restraint or se- ioral condition; and
clusion for the management of violent (D) The need to continue or termi-
or self-destructive behavior, a physi- nate the restraint or seclusion.
cian or other licensed independent (13) States are free to have require-
practitioner who is responsible for the ments by statute or regulation that are
care of the patient as specified under more restrictive than those contained
§ 482.12(c) of this part and authorized to in paragraph (e)(12)(i) of this section.
order restraint or seclusion by hospital (14) If the face-to-face evaluation
policy in accordance with State law specified in paragraph (e)(12) of this
must see and assess the patient. section is conducted by a trained reg-
(iii) Each order for restraint used to istered nurse or physician assistant,
ensure the physical safety of the non- the trained registered nurse or physi-
violent or non-self-destructive patient cian assistant must consult the attend-
may be renewed as authorized by hos- ing physician or other licensed inde-
pital policy. pendent practitioner who is responsible
(9) Restraint or seclusion must be for the care of the patient as specified
discontinued at the earliest possible under § 482.12(c) as soon as possible
time, regardless of the length of time after the completion of the 1-hour face-
identified in the order. to-face evaluation.
(10) The condition of the patient who (15) All requirements specified under
is restrained or secluded must be mon- this paragraph are applicable to the si-
itored by a physician, other licensed multaneous use of restraint and seclu-
independent practitioner or trained sion. Simultaneous restraint and seclu-
staff that have completed the training sion use is only permitted if the pa-
criteria specified in paragraph (f) of tient is continually monitored—

this section at an interval determined (i) Face-to-face by an assigned,
by hospital policy. trained staff member; or
11
§ 482.13 42 CFR Ch. IV (10–1–17 Edition)
(ii) By trained staff using both video in the hospital, including training in
and audio equipment. This monitoring how to recognize and respond to signs
must be in close proximity to the pa- of physical and psychological distress
tient. (for example, positional asphyxia);
(16) When restraint or seclusion is (v) Clinical identification of specific
used, there must be documentation in behavioral changes that indicate that
the patient’s medical record of the fol- restraint or seclusion is no longer nec-
lowing: essary.
(i) The 1-hour face-to-face medical (vi) Monitoring the physical and psy-
and behavioral evaluation if restraint chological well-being of the patient
or seclusion is used to manage violent who is restrained or secluded, including
or self-destructive behavior; but not limited to, respiratory and cir-
(ii) A description of the patient’s be- culatory status, skin integrity, vital
havior and the intervention used; signs, and any special requirements
(iii) Alternatives or other less re- specified by hospital policy associated
strictive interventions attempted (as with the 1-hour face-to-face evaluation.
applicable); (vii) The use of first aid techniques
(iv) The patient’s condition or symp- and certification in the use of
tom(s) that warranted the use of the cardiopulmonary resuscitation, includ-
restraint or seclusion; and ing required periodic recertification.
(v) The patient’s response to the
(3) Trainer requirements. Individuals
intervention(s) used, including the ra-
providing staff training must be quali-
tionale for continued use of the inter-
fied as evidenced by education, train-
vention.
ing, and experience in techniques used
(f) Standard: Restraint or seclusion:
to address patients’ behaviors.
Staff training requirements. The patient
(4) Training documentation. The hos-
has the right to safe implementation of
pital must document in the staff per-
restraint or seclusion by trained staff.
sonnel records that the training and
(1) Training intervals. Staff must be
demonstration of competency were suc-
trained and able to demonstrate com-
cessfully completed.
petency in the application of re-
straints, implementation of seclusion, (g) Standard: Death reporting require-
monitoring, assessment, and providing ments: Hospitals must report deaths as-
care for a patient in restraint or seclu- sociated with the use of seclusion or re-
sion— straint.
(i) Before performing any of the ac- (1) With the exception of deaths de-
tions specified in this paragraph; scribed under paragraph (g)(2) of this
(ii) As part of orientation; and section, the hospital must report the
(iii) Subsequently on a periodic basis following information to CMS by tele-
consistent with hospital policy. phone, facsimile, or electronically, as
(2) Training content. The hospital determined by CMS, no later than the
must require appropriate staff to have close of business on the next business
education, training, and demonstrated day following knowledge of the pa-
knowledge based on the specific needs tient’s death:
of the patient population in at least (i) Each death that occurs while a pa-
the following: tient is in restraint or seclusion.
(i) Techniques to identify staff and (ii) Each death that occurs within 24
patient behaviors, events, and environ- hours after the patient has been re-
mental factors that may trigger cir- moved from restraint or seclusion.
cumstances that require the use of a (iii) Each death known to the hos-
restraint or seclusion. pital that occurs within 1 week after
(ii) The use of nonphysical interven- restraint or seclusion where it is rea-
tion skills. sonable to assume that use of restraint
(iii) Choosing the least restrictive or placement in seclusion contributed
intervention based on an individualized directly or indirectly to a patient’s
assessment of the patient’s medical, or death, regardless of the type(s) of re-
behavioral status or condition. straint used on the patient during this

(iv) The safe application and use of time. ‘‘Reasonable to assume’’ in this
all types of restraint or seclusion used context includes, but is not limited to,
12
deaths related to restrictions of move- visitation rights, including any clinical

ment for prolonged periods of time, or restriction or limitation on such
death related to chest compression, re- rights, when he or she is informed of
striction of breathing, or asphyxiation. his or her other rights under this sec-
(2) When no seclusion has been used tion.
and when the only restraints used on (2) Inform each patient (or support
the patient are those applied exclu- person, where appropriate) of the right,
sively to the patient’s wrist(s), and subject to his or her consent, to receive
which are composed solely of soft, non- the visitors whom he or she designates,
rigid, cloth-like materials, the hospital including, but not limited to, a spouse,
staff must record in an internal log or a domestic partner (including a same-
other system, the following informa- sex domestic partner), another family
tion: member, or a friend, and his or her
(i) Any death that occurs while a pa- right to withdraw or deny such consent
tient is in such restraints. at any time.
(ii) Any death that occurs within 24 (3) Not restrict, limit, or otherwise
hours after a patient has been removed deny visitation privileges on the basis
from such restraints. of race, color, national origin, religion,
(3) The staff must document in the sex, gender identity, sexual orienta-
patient’s medical record the date and tion, or disability.
time the death was: (4) Ensure that all visitors enjoy full
(i) Reported to CMS for deaths de- and equal visitation privileges con-
scribed in paragraph (g)(1) of this sec- sistent with patient preferences.
tion; or [71 FR 71426, Dec. 8, 2006, as amended at 75
(ii) Recorded in the internal log or FR 70844, Nov. 19, 2010; 77 FR 29074, May 16,
other system for deaths described in 2012]
paragraph (g)(2) of this section.
(4) For deaths described in paragraph § 482.15 Condition of participation:
(g)(2) of this section, entries into the Emergency preparedness.
internal log or other system must be The hospital must comply with all
documented as follows: applicable Federal, State, and local
(i) Each entry must be made not emergency preparedness requirements.
later than seven days after the date of The hospital must develop and main-
death of the patient. tain a comprehensive emergency pre-
(ii) Each entry must document the paredness program that meets the re-
patient’s name, date of birth, date of quirements of this section, utilizing an
death, name of attending physician or all-hazards approach. The emergency
other licensed independent practitioner preparedness program must include,
who is responsible for the care of the but not be limited to, the following ele-
patient as specified under § 482.12(c), ments:
medical record number, and primary (a) Emergency plan. The hospital must
diagnosis(es). develop and maintain an emergency
(iii) The information must be made preparedness plan that must be re-
available in either written or elec- viewed, and updated at least annually.
tronic form to CMS immediately upon The plan must do the following:
request. (1) Be based on and include a docu-
(h) Standard: Patient visitation rights. mented, facility-based and community-
A hospital must have written policies based risk assessment, utilizing an all-
and procedures regarding the visitation hazards approach.
rights of patients, including those set- (2) Include strategies for addressing
ting forth any clinically necessary or emergency events identified by the
reasonable restriction or limitation risk assessment.
that the hospital may need to place on (3) Address patient population, in-
such rights and the reasons for the cluding, but not limited to, persons at-
clinical restriction or limitation. A risk; the type of services the hospital
hospital must meet the following re- has the ability to provide in an emer-
quirements: gency; and continuity of operations, in-

(1) Inform each patient (or support cluding delegations of authority and
person, where appropriate) of his or her succession plans.
13
§ 482.15 42 CFR Ch. IV (10–1–17 Edition)
(4) Include a process for cooperation (5) A system of medical documenta-

and collaboration with local, tribal, re- tion that preserves patient informa-
gional, State, and Federal emergency tion, protects confidentiality of patient
preparedness officials’ efforts to main- information, and secures and main-
tain an integrated response during a tains the availability of records.
disaster or emergency situation, in- (6) The use of volunteers in an emer-
cluding documentation of the hos- gency and other emergency staffing
pital’s efforts to contact such officials strategies, including the process and
and, when applicable, its participation role for integration of State and Feder-
in collaborative and cooperative plan- ally designated health care profes-
ning efforts. sionals to address surge needs during
(b) Policies and procedures. The hos- an emergency.
pital must develop and implement (7) The development of arrangements
emergency preparedness policies and with other hospitals and other pro-
procedures, based on the emergency viders to receive patients in the event
plan set forth in paragraph (a) of this of limitations or cessation of oper-
section, risk assessment at paragraph ations to maintain the continuity of
(a)(1) of this section, and the commu- services to hospital patients.
nication plan at paragraph (c) of this (8) The role of the hospital under a
section. The policies and procedures waiver declared by the Secretary, in
must be reviewed and updated at least accordance with section 1135 of the
annually. At a minimum, the policies Act, in the provision of care and treat-
and procedures must address the fol- ment at an alternate care site identi-
lowing: fied by emergency management offi-
(1) The provision of subsistence needs cials.
for staff and patients, whether they (c) Communication plan. The hospital
evacuate or shelter in place, include, must develop and maintain an emer-
but are not limited to the following: gency preparedness communication
(i) Food, water, medical, and pharma- plan that complies with Federal, State,
ceutical supplies. and local laws and must be reviewed
(ii) Alternate sources of energy to and updated at least annually. The
maintain the following: communication plan must include all
of the following:
(A) Temperatures to protect patient
(1) Names and contact information
health and safety and for the safe and
for the following:
sanitary storage of provisions.
(i) Staff.
(B) Emergency lighting.
(ii) Entities providing services under
(C) Fire detection, extinguishing, and arrangement.
alarm systems. (iii) Patients’ physicians.
(D) Sewage and waste disposal. (iv) Other hospitals and CAHs
(2) A system to track the location of (v) Volunteers.
on-duty staff and sheltered patients in (2) Contact information for the fol-
the hospital’s care during an emer- lowing:
gency. If on-duty staff and sheltered (i) Federal, State, tribal, regional,
patients are relocated during the emer- and local emergency preparedness
gency, the hospital must document the staff.
specific name and location of the re- (ii) Other sources of assistance.
ceiving facility or other location. (3) Primary and alternate means for
(3) Safe evacuation from the hospital, communicating with the following:
which includes consideration of care (i) Hospital’s staff.
and treatment needs of evacuees; staff (ii) Federal, State, tribal, regional,
responsibilities; transportation; identi- and local emergency management
fication of evacuation location(s); and agencies.
primary and alternate means of com- (4) A method for sharing information
munication with external sources of as- and medical documentation for pa-
sistance. tients under the hospital’s care, as nec-
(4) A means to shelter in place for pa- essary, with other health care pro-
tients, staff, and volunteers who re- viders to maintain the continuity of
main in the facility. care.
14
(5) A means, in the event of an evacu- (A) A second full-scale exercise that
ation, to release patient information as is community-based or individual, fa-
permitted under 45 CFR 164.510(b)(1)(ii). cility-based.
(6) A means of providing information (B) A tabletop exercise that includes
about the general condition and loca- a group discussion led by a facilitator,
tion of patients under the facility’s using a narrated, clinically-relevant
care as permitted under 45 CFR emergency scenario, and a set of prob-
164.510(b)(4). lem statements, directed messages, or
(7) A means of providing information prepared questions designed to chal-
about the hospital’s occupancy, needs, lenge an emergency plan.
and its ability to provide assistance, to (iii) Analyze the hospital’s response
the authority having jurisdiction, the to and maintain documentation of all
Incident Command Center, or designee. drills, tabletop exercises, and emer-
(d) Training and testing. The hospital gency events, and revise the hospital’s
must develop and maintain an emer- emergency plan, as needed.
gency preparedness training and test- (e) Emergency and standby power sys-
ing program that is based on the emer- tems. The hospital must implement
gency plan set forth in paragraph (a) of emergency and standby power systems
this section, risk assessment at para- based on the emergency plan set forth
graph (a)(1) of this section, policies and in paragraph (a) of this section and in
procedures at paragraph (b) of this sec- the policies and procedures plan set
tion, and the communication plan at forth in paragraphs (b)(1)(i) and (ii) of
paragraph (c) of this section. The train- this section.
ing and testing program must be re- (1) Emergency generator location. The
viewed and updated at least annually. generator must be located in accord-
(1) Training program. The hospital ance with the location requirements
must do all of the following: found in the Health Care Facilities
(i) Initial training in emergency pre- Code (NFPA 99 and Tentative Interim
paredness policies and procedures to all Amendments TIA 12–2, TIA 12–3, TIA
new and existing staff, individuals pro- 12–4, TIA 12–5, and TIA 12–6), Life Safe-
viding services under arrangement, and ty Code (NFPA 101 and Tentative In-
volunteers, consistent with their ex- terim Amendments TIA 12–1, TIA 12–2,
pected role. TIA 12–3, and TIA 12–4), and NFPA 110,
(ii) Provide emergency preparedness when a new structure is built or when
training at least annually. an existing structure or building is ren-
(iii) Maintain documentation of the ovated.
training. (2) Emergency generator inspection and
(iv) Demonstrate staff knowledge of testing. The hospital must implement
emergency procedures. the emergency power system inspec-
(2) Testing. The hospital must con- tion, testing, and maintenance require-
duct exercises to test the emergency ments found in the Health Care Facili-
plan at least annually. The hospital ties Code, NFPA 110, and Life Safety
must do all of the following: Code.
(i) Participate in a full-scale exercise (3) Emergency generator fuel. Hospitals
that is community-based or when a that maintain an onsite fuel source to
community-based exercise is not acces- power emergency generators must have
sible, an individual, facility-based. If a plan for how it will keep emergency
the hospital experiences an actual nat- power systems operational during the
ural or man-made emergency that re- emergency, unless it evacuates.
quires activation of the emergency (f) Integrated healthcare systems. If a
plan, the hospital is exempt from en- hospital is part of a healthcare system
gaging in a community-based or indi- consisting of multiple separately cer-
vidual, facility-based full-scale exer- tified healthcare facilities that elects
cise for 1 year following the onset of to have a unified and integrated emer-
the actual event. gency preparedness program, the hos-
(ii) Conduct an additional exercise pital may choose to participate in the

that may include, but is not limited to healthcare system’s coordinated emer-
the following: gency preparedness program. If elected,
15
§ 482.15 42 CFR Ch. IV (10–1–17 Edition)
the unified and integrated emergency Director of the Office of the Federal
preparedness program must— Register in accordance with 5 U.S.C.
(1) Demonstrate that each separately 552(a) and 1 CFR part 51. You may ob-
certified facility within the system ac- tain the material from the sources list-
tively participated in the development ed below. You may inspect a copy at
of the unified and integrated emer- the CMS Information Resource Center,
gency preparedness program. 7500 Security Boulevard, Baltimore,
(2) Be developed and maintained in a MD or at the National Archives and
manner that takes into account each Records Administration (NARA). For
separately certified facility’s unique
information on the availability of this
circumstances, patient populations,
material at NARA, call 202–741–6030, or
and services offered.
(3) Demonstrate that each separately go to: http://www.archives.gov/
certified facility is capable of actively federallregister/
using the unified and integrated emer- codeloflfederallregulations/
gency preparedness program and is in ibrllocations.html. If any changes in
compliance with the program. this edition of the Code are incor-
(4) Include a unified and integrated porated by reference, CMS will publish
emergency plan that meets the require- a document in the FEDERAL REGISTER
ments of paragraphs (a)(2), (3), and (4) to announce the changes.
of this section. The unified and inte- (1) National Fire Protection Associa-
grated emergency plan must also be tion, 1 Batterymarch Park, Quincy,
based on and include the following: MA 02169, www.nfpa.org, 1.617.770.3000.
(i) A documented community-based (i) NFPA 99, Health Care Facilities
risk assessment, utilizing an all-haz- Code, 2012 edition, issued August 11,
ards approach. 2011.
(ii) A documented individual facility-
(ii) Technical interim amendment
based risk assessment for each sepa-
rately certified facility within the (TIA) 12–2 to NFPA 99, issued August
health system, utilizing an all-hazards 11, 2011.
approach. (iii) TIA 12–3 to NFPA 99, issued Au-
(5) Include integrated policies and gust 9, 2012.
procedures that meet the requirements (iv) TIA 12–4 to NFPA 99, issued
set forth in paragraph (b) of this sec- March 7, 2013.
tion, a coordinated communication (v) TIA 12–5 to NFPA 99, issued Au-
plan and training and testing programs gust 1, 2013.
that meet the requirements of para- (vi) TIA 12–6 to NFPA 99, issued
graphs (c) and (d) of this section, re- March 3, 2014.
spectively. (vii) NFPA 101, Life Safety Code, 2012
(g) Transplant hospitals. If a hospital
edition, issued August 11, 2011.
has one or more transplant centers (as
defined in § 482.70)— (viii) TIA 12–1 to NFPA 101, issued
(1) A representative from each trans- August 11, 2011.
plant center must be included in the (ix) TIA 12–2 to NFPA 101, issued Oc-
development and maintenance of the tober 30, 2012.
hospital’s emergency preparedness pro- (x) TIA 12–3 to NFPA 101, issued Oc-
gram; and tober 22, 2013.
(2) The hospital must develop and (xi) TIA 12–4 to NFPA 101, issued Oc-
maintain mutually agreed upon proto- tober 22, 2013.
cols that address the duties and respon- (xii) NFPA 110, Standard for Emer-
sibilities of the hospital, each trans- gency and Standby Power Systems,
plant center, and the OPO for the DSA 2010 edition, including TIAs to chapter
where the hospital is situated, unless 7, issued August 6, 2009.
the hospital has been granted a waiver
(2) [Reserved]
to work with another OPO, during an
emergency. [81 FR 64028, Sept. 16, 2016; 81 FR 80594, Nov.
(h) The standards incorporated by 16, 2016]

reference in this section are approved
for incorporation by reference by the
16
Subpart C—Basic Hospital (i) Focus on high-risk, high-volume,

Functions or problem-prone areas;
(ii) Consider the incidence, preva-
§ 482.21 Condition of participation: lence, and severity of problems in those
Quality assessment and perform- areas; and
ance improvement program. (iii) Affect health outcomes, patient
The hospital must develop, imple- safety, and quality of care.
ment, and maintain an effective, ongo- (2) Performance improvement activi-
ing, hospital-wide, data-driven quality ties must track medical errors and ad-
assessment and performance improve- verse patient events, analyze their
ment program. The hospital’s gov- causes, and implement preventive ac-
erning body must ensure that the pro- tions and mechanisms that include
gram reflects the complexity of the feedback and learning throughout the
hospital’s organization and services; hospital.
involves all hospital departments and (3) The hospital must take actions
services (including those services fur- aimed at performance improvement
nished under contract or arrangement); and, after implementing those actions,
and focuses on indicators related to im- the hospital must measure its success,
proved health outcomes and the pre- and track performance to ensure that
vention and reduction of medical er- improvements are sustained.
rors. The hospital must maintain and (d) Standard: Performance improvement
demonstrate evidence of its QAPI pro- projects. As part of its quality assess-
gram for review by CMS. ment and performance improvement
program, the hospital must conduct
(a) Standard: Program scope. (1) The
performance improvement projects.
program must include, but not be lim-
(1) The number and scope of distinct
ited to, an ongoing program that shows
improvement projects conducted annu-
measurable improvement in indicators
ally must be proportional to the scope
for which there is evidence that it will
and complexity of the hospital’s serv-
improve health outcomes and identify
ices and operations.
and reduce medical errors.
(2) A hospital may, as one of its
(2) The hospital must measure, ana-
projects, develop and implement an in-
lyze, and track quality indicators, in-
formation technology system explic-
cluding adverse patient events, and
itly designed to improve patient safety
other aspects of performance that as-
and quality of care. This project, in its
sess processes of care, hospital service
initial stage of development, does not
and operations.
need to demonstrate measurable im-
(b) Standard: Program data. (1) The provement in indicators related to
program must incorporate quality indi- health outcomes.
cator data including patient care data, (3) The hospital must document what
and other relevant data, for example, quality improvement projects are
information submitted to, or received being conducted, the reasons for con-
from, the hospital’s Quality Improve- ducting these projects, and the measur-
ment Organization. able progress achieved on these
(2) The hospital must use the data projects.
collected to— (4) A hospital is not required to par-
(i) Monitor the effectiveness and ticipate in a QIO cooperative project,
safety of services and quality of care; but its own projects are required to be
and of comparable effort.
(ii) Identify opportunities for im- (e) Standard: Executive responsibilities.
provement and changes that will lead The hospital’s governing body (or orga-
to improvement. nized group or individual who assumes
(3) The frequency and detail of data full legal authority and responsibility
collection must be specified by the hos- for operations of the hospital), medical
pital’s governing body. staff, and administrative officials are
(c) Standard: Program activities. (1) responsible and accountable for ensur-
The hospital must set priorities for its ing the following:
performance improvement activities (1) That an ongoing program for qual-
that— ity improvement and patient safety,
17
§ 482.22 42 CFR Ch. IV (10–1–17 Edition)
including the reduction of medical er- through an agreement with a distant-

rors, is defined, implemented, and site hospital, the governing body of the
maintained. hospital whose patients are receiving
(2) That the hospital-wide quality as- the telemedicine services may choose,
sessment and performance improve- in lieu of the requirements in para-
ment efforts address priorities for im- graphs (a)(1) and (a)(2) of this section,
proved quality of care and patient safe- to have its medical staff rely upon the
ty; and that all improvement actions credentialing and privileging decisions
are evaluated. made by the distant-site hospital when
(3) That clear expectations for safety making recommendations on privileges
are established. for the individual distant-site physi-
(4) That adequate resources are allo- cians and practitioners providing such
cated for measuring, assessing, improv- services, if the hospital’s governing
ing, and sustaining the hospital’s per- body ensures, through its written
formance and reducing risk to patients. agreement with the distant-site hos-
(5) That the determination of the pital, that all of the following provi-
number of distinct improvement sions are met:
projects is conducted annually. (i) The distant-site hospital providing
[68 FR 3454, Jan. 24, 2003] the telemedicine services is a Medi-
care-participating hospital.
§ 482.22 Condition of participation: (ii) The individual distant-site physi-
Medical staff. cian or practitioner is privileged at the
The hospital must have an organized distant-site hospital providing the tele-
medical staff that operates under by- medicine services, which provides a
laws approved by the governing body, current list of the distant-site physi-
and which is responsible for the quality cian’s or practitioner’s privileges at
of medical care provided to patients by the distant-site hospital.
the hospital. (iii) The individual distant-site phy-
(a) Standard: Eligibility and process for sician or practitioner holds a license
appointment to medical staff. The med- issued or recognized by the State in
ical staff must be composed of doctors which the hospital whose patients are
of medicine or osteopathy. In accord- receiving the telemedicine services is
ance with State law, including scope- located.
of-practice laws, the medical staff may (iv) With respect to a distant-site
also include other categories of physi- physician or practitioner, who holds
cians (as listed at § 482.12(c)(1)) and current privileges at the hospital
non-physician practitioners who are whose patients are receiving the tele-
determined to be eligible for appoint- medicine services, the hospital has evi-
ment by the governing body. dence of an internal review of the dis-
(1) The medical staff must periodi- tant-site physician’s or practitioner’s
cally conduct appraisals of its mem- performance of these privileges and
bers. sends the distant-site hospital such
(2) The medical staff must examine performance information for use in the
the credentials of all eligible can- periodic appraisal of the distant-site
didates for medical staff membership physician or practitioner. At a min-
and make recommendations to the gov- imum, this information must include
erning body on the appointment of all adverse events that result from the
these candidates in accordance with telemedicine services provided by the
State law, including scope-of-practice distant-site physician or practitioner
laws, and the medical staff bylaws, to the hospital’s patients and all com-
rules, and regulations. A candidate who plaints the hospital has received about
has been recommended by the medical the distant-site physician or practi-
staff and who has been appointed by tioner.
the governing body is subject to all (4) When telemedicine services are
medical staff bylaws, rules, and regula- furnished to the hospital’s patients
tions, in addition to the requirements through an agreement with a distant-
contained in this section. site telemedicine entity, the governing

(3) When telemedicine services are body of the hospital whose patients are
furnished to the hospital’s patients receiving the telemedicine services
18
may choose, in lieu of the requirements and all complaints the hospital has re-
in paragraphs (a)(1) and (a)(2) of this ceived about the distant-site physician
section, to have its medical staff rely or practitioner.
upon the credentialing and privileging (b) Standard: Medical staff organiza-
decisions made by the distant-site tele- tion and accountability. The medical
medicine entity when making rec- staff must be well organized and ac-
ommendations on privileges for the in- countable to the governing body for
dividual distant-site physicians and the quality of the medical care pro-
practitioners providing such services, if vided to patients.
the hospital’s governing body ensures, (1) The medical staff must be orga-
through its written agreement with the nized in a manner approved by the gov-
distant-site telemedicine entity, that
erning body.
the distant-site telemedicine entity
(2) If the medical staff has an execu-
furnishes services that, in accordance
with § 482.12(e), permit the hospital to tive committee, a majority of the
comply with all applicable conditions members of the committee must be
of participation for the contracted doctors of medicine or osteopathy.
services. The hospital’s governing body (3) The responsibility for organiza-
must also ensure, through its written tion and conduct of the medical staff
agreement with the distant-site tele- must be assigned only to one of the fol-
medicine entity, that all of the following:
lowing provisions are met: (i) An individual doctor of medicine
(i) The distant-site telemedicine enti- or osteopathy.
ty’s medical staff credentialing and (ii) A doctor of dental surgery or den-
privileging process and standards at tal medicine, when permitted by State
least meet the standards at § 482.12(a)(1) law of the State in which the hospital
through (a)(7) and § 482.22(a)(1) through is located.
(a)(2). (iii) A doctor of podiatric medicine,
(ii) The individual distant-site physi- when permitted by State law of the
cian or practitioner is privileged at the State in which the hospital is located.
distant-site telemedicine entity pro- (4) If a hospital is part of a hospital
viding the telemedicine services, which system consisting of multiple sepa-
provides the hospital with a current rately certified hospitals and the sys-
list of the distant-site physician’s or tem elects to have a unified and inte-
practitioner’s privileges at the distant- grated medical staff for its member
site telemedicine entity. hospitals, after determining that such
(iii) The individual distant-site phy- a decision is in accordance with all ap-
sician or practitioner holds a license plicable State and local laws, each sep-
issued or recognized by the State in arately certified hospital must dem-
which the hospital whose patients are
onstrate that:
receiving such telemedicine services is
(i) The medical staff members of each
located.
(iv) With respect to a distant-site separately certified hospital in the sys-
physician or practitioner, who holds tem (that is, all medical staff members
current privileges at the hospital who hold specific privileges to practice
whose patients are receiving the tele- at that hospital) have voted by major-
medicine services, the hospital has evi- ity, in accordance with medical staff
dence of an internal review of the dis- bylaws, either to accept a unified and
tant-site physician’s or practitioner’s integrated medical staff structure or to
performance of these privileges and opt out of such a structure and to
sends the distant-site telemedicine en- maintain a separate and distinct med-
tity such performance information for ical staff for their respective hospital;
use in the periodic appraisal of the dis- (ii) The unified and integrated med-
tant-site physician or practitioner. At ical staff has bylaws, rules, and re-
a minimum, this information must in- quirements that describe its processes
clude all adverse events that result for self-governance, appointment,
from the telemedicine services pro- credentialing, privileging, and over-

vided by the distant-site physician or sight, as well as its peer review policies
practitioner to the hospital’s patients, and due process rights guarantees, and
19
§ 482.23 42 CFR Ch. IV (10–1–17 Edition)
which include a process for the mem- accordance with State law and hospital
bers of the medical staff of each sepa- policy.
rately certified hospital (that is, all (ii) An updated examination of the
medical staff members who hold spe- patient, including any changes in the
cific privileges to practice at that hos- patient’s condition, be completed and
pital) to be advised of their rights to documented within 24 hours after ad-
opt out of the unified and integrated mission or registration, but prior to
medical staff structure after a major- surgery or a procedure requiring anes-
ity vote by the members to maintain a thesia services, when the medical his-
separate and distinct medical staff for tory and physical examination are
their hospital;
completed within 30 days before admis-
(iii) The unified and integrated med-
sion or registration. The updated ex-
ical staff is established in a manner
that takes into account each member amination of the patient, including any
hospital’s unique circumstances and changes in the patient’s condition,
any significant differences in patient must be completed and documented by
populations and services offered in a physician (as defined in section
each hospital; and 1861(r) of the Act), an oromaxillofacial
(iv) The unified and integrated med- surgeon, or other qualified licensed in-
ical staff establishes and implements dividual in accordance with State law
policies and procedures to ensure that and hospital policy.
the needs and concerns expressed by (6) Include criteria for determining
members of the medical staff, at each the privileges to be granted to indi-
of its separately certified hospitals, re- vidual practitioners and a procedure
gardless of practice or location, are for applying the criteria to individuals
given due consideration, and that the requesting privileges. For distant-site
unified and integrated medical staff physicians and practitioners requesting
has mechanisms in place to ensure that privileges to furnish telemedicine serv-
issues localized to particular hospitals ices under an agreement with the hos-
are duly considered and addressed. pital, the criteria for determining
(c) Standard: Medical staff bylaws. The privileges and the procedure for apply-
medical staff must adopt and enforce ing the criteria are also subject to the
bylaws to carry out its responsibilities.
requirements in § 482.12(a)(8) and (a)(9),
The bylaws must:
and § 482.22(a)(3) and (a)(4).
(1) Be approved by the governing
body. (d) Standard: Autopsies. The medical
(2) Include a statement of the duties staff should attempt to secure autop-
and privileges of each category of med- sies in all cases of unusual deaths and
ical staff (e.g., active, courtesy, etc.) of medical-legal and educational inter-
(3) Describe the organization of the est. The mechanism for documenting
medical staff. permission to perform an autopsy must
(4) Describe the qualifications to be be defined. There must be a system for
met by a candidate in order for the notifying the medical staff, and specifi-
medical staff to recommend that the cally the attending practitioner, when
candidate be appointed by the gov- an autopsy is being performed.
erning body.
[51 FR 22042, June 17, 1986, as amended at 59
(5) Include a requirement that—
FR 64152, Dec. 13, 1994; 71 FR 68694, Nov. 27,
(i) A medical history and physical ex- 2006; 72 FR 66933, Nov. 27, 2007; 76 FR 25563,
amination be completed and docu- May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR
mented for each patient no more than 27154, May 12, 2014]
30 days before or 24 hours after admis-
sion or registration, but prior to sur- § 482.23 Condition of participation:
gery or a procedure requiring anes- Nursing services.
thesia services. The medical history
The hospital must have an organized
and physical examination must be
nursing service that provides 24-hour
completed and documented by a physi-
cian (as defined in section 1861(r) of the nursing services. The nursing services
Act), an oromaxillofacial surgeon, or must be furnished or supervised by a
other qualified licensed individual in registered nurse.
20
(a) Standard: Organization. The hos- personnel which occur within the re-
pital must have a well-organized serv- sponsibility of the nursing service.
ice with a plan of administrative au- (c) Standard: Preparation and adminis-
thority and delineation of responsibil- tration of drugs. (1) Drugs and
ities for patient care. The director of biologicals must be prepared and ad-
the nursing service must be a licensed ministered in accordance with Federal
registered nurse. He or she is respon- and State laws, the orders of the prac-
sible for the operation of the service, titioner or practitioners responsible for
including determining the types and the patient’s care as specified under
numbers of nursing personnel and staff § 482.12(c), and accepted standards of
necessary to provide nursing care for practice.
all areas of the hospital. (i) Drugs and biologicals may be pre-
(b) Standard: Staffing and delivery of pared and administered on the orders
care. The nursing service must have of other practitioners not specified
adequate numbers of licensed reg- under § 482.12(c) only if such practi-
istered nurses, licensed practical (voca- tioners are acting in accordance with
tional) nurses, and other personnel to State law, including scope-of-practice
provide nursing care to all patients as laws, hospital policies, and medical
needed. There must be supervisory and staff bylaws, rules, and regulations.
staff personnel for each department or (ii) Drugs and biologicals may be pre-
nursing unit to ensure, when needed, pared and administered on the orders
the immediate availability of a reg- contained within pre-printed and elec-
istered nurse for bedside care of any tronic standing orders, order sets, and
patient. protocols for patient orders only if
(1) The hospital must provide 24-hour such orders meet the requirements of
nursing services furnished or super- § 482.24(c)(3).
vised by a registered nurse, and have a (2) All drugs and biologicals must be
licensed practical nurse or registered administered by, or under supervision
nurse on duty at all times, except for of, nursing or other personnel in ac-
rural hospitals that have in effect a 24- cordance with Federal and State laws
hour nursing waiver granted under and regulations, including applicable
§ 488.54(c) of this chapter. licensing requirements, and in accord-
(2) The nursing service must have a ance with the approved medical staff
procedure to ensure that hospital nurs- policies and procedures.
ing personnel for whom licensure is re- (3) With the exception of influenza
quired have valid and current licen- and pneumococcal vaccines, which may
sure. be administered per physician-ap-
(3) A registered nurse must supervise proved hospital policy after an assess-
and evaluate the nursing care for each ment of contraindications, orders for
patient. drugs and biologicals must be docu-
(4) The hospital must ensure that the mented and signed by a practitioner
nursing staff develops, and keeps cur- who is authorized to write orders in ac-
rent, a nursing care plan for each pa- cordance with State law and hospital
tient. The nursing care plan may be policy, and who is responsible for the
part of an interdisciplinary care plan. care of the patient as specified under
(5) A registered nurse must assign § 482.12(c).
the nursing care of each patient to (i) If verbal orders are used, they are
other nursing personnel in accordance to be used infrequently.
with the patient’s needs and the spe- (ii) When verbal orders are used, they
cialized qualifications and competence must only be accepted by persons who
of the nursing staff available. are authorized to do so by hospital pol-
(6) Non-employee licensed nurses who icy and procedures consistent with
are working in the hospital must ad- Federal and State law.
here to the policies and procedures of (iii) Orders for drugs and biologicals
the hospital. The director of nursing may be documented and signed by
service must provide for the adequate other practitioners not specified under
supervision and evaluation of the clin- § 482.12(c) only if such practitioners are
ical activities of non-employee nursing acting in accordance with State law,
21
§ 482.24 42 CFR Ch. IV (10–1–17 Edition)
including scope-of-practice laws, hos- son where appropriate) to self-admin-

pital policies, and medical staff bylaws, ister the specified medication(s), and
rules, and regulations. also determine if the patient (or the
(4) Blood transfusions and intra- patient’s caregiver/support person
venous medications must be adminis- where appropriate) needs instruction in
tered in accordance with State law and the safe and accurate administration of
approved medical staff policies and the specified medication(s).
procedures. (C) Identify the specified medica-
(5) There must be a hospital proce- tion(s) and visually evaluate the medi-
dure for reporting transfusion reac- cation(s) for integrity.
tions, adverse drug reactions, and er- (D) Address the security of the medi-
rors in administration of drugs. cation(s) for each patient.
(6) The hospital may allow a patient (E) Document the administration of
(or his or her caregiver/support person each medication, as reported by the pa-
where appropriate) to self-administer tient (or the patient’s caregiver/sup-
both hospital-issued medications and port person where appropriate), in the
the patient’s own medications brought patient’s medical record.
into the hospital, as defined and speci- [51 FR 22042, June 17, 1986, as amended at 67
fied in the hospital’s policies and pro- FR 61814, Oct. 2, 2002; 71 FR 68694, Nov. 27,
cedures. 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074,
(i) If the hospital allows a patient to May 16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR
self-administer specific hospital-issued 44129, July 30, 2014]
medications, then the hospital must
have policies and procedures in place § 482.24 Condition of participation:
to: Medical record services.
(A) Ensure that a practitioner re- The hospital must have a medical
sponsible for the care of the patient record service that has administrative
has issued an order, consistent with responsibility for medical records. A
hospital policy, permitting self-admin- medical record must be maintained for
istration. every individual evaluated or treated
(B) Assess the capacity of the patient in the hospital.
(or the patient’s caregiver/support per- (a) Standard: Organization and staff-
son where appropriate) to self-admin- ing. The organization of the medical
ister the specified medication(s). record service must be appropriate to
(C) Instruct the patient (or the pa- the scope and complexity of the serv-
tient’s caregiver/support person where ices performed. The hospital must em-
appropriate) in the safe and accurate ploy adequate personnel to ensure
administration of the specified medica- prompt completion, filing, and re-
tion(s). trieval of records.
(D) Address the security of the medi- (b) Standard: Form and retention of
cation(s) for each patient. record. The hospital must maintain a
(E) Document the administration of medical record for each inpatient and
each medication, as reported by the pa- outpatient. Medical records must be
tient (or the patient’s caregiver/sup- accurately written, promptly com-
port person where appropriate), in the pleted, properly filed and retained, and
patient’s medical record. accessible. The hospital must use a sys-
(ii) If the hospital allows a patient to tem of author identification and record
self-administer his or her own specific maintenance that ensures the integrity
medications brought into the hospital, of the authentification and protects
then the hospital must have policies the security of all record entries.
and procedures in place to: (1) Medical records must be retained
(A) Ensure that a practitioner rein their original or legally reproduced
sponsible for the care of the patient form for a period of at least 5 years.
has issued an order, consistent with (2) The hospital must have a system
hospital policy, permitting self-admin- of coding and indexing medical records.
istration of medications the patient The system must allow for timely re-
brought into the hospital. trieval by diagnosis and procedure, in

(B) Assess the capacity of the patient order to support medical care evalua-
(or the patient’s caregiver/support per- tion studies.
22
(3) The hospital must have a proce- or by another practitioner responsible

dure for ensuring the confidentiality of for the care of the patient only if such
patient records. In-formation from or a practitioner is acting in accordance
copies of records may be released only with State law, including scope-of-
to authorized individuals, and the hos- practice laws, hospital policies, and
pital must ensure that unauthorized medical staff bylaws, rules, and regula-
individuals cannot gain access to or tions.
alter patient records. Original medical (4) All records must document the
records must be released by the hos- following, as appropriate:
pital only in accordance with Federal
(i) Evidence of—
or State laws, court orders, or sub-
poenas. (A) A medical history and physical
(c) Standard: Content of record. The examination completed and docu-
medical record must contain informa- mented no more than 30 days before or
tion to justify admission and continued 24 hours after admission or registra-
hospitalization, support the diagnosis, tion, but prior to surgery or a proce-
and describe the patient’s progress and dure requiring anesthesia services. The
response to medications and services. medical history and physical examina-
(1) All patient medical record entries tion must be placed in the patient’s
must be legible, complete, dated, medical record within 24 hours after
timed, and authenticated in written or admission or registration, but prior to
electronic form by the person respon- surgery or a procedure requiring anes-
sible for providing or evaluating the thesia services.
service provided, consistent with hos- (B) An updated examination of the
pital policies and procedures. patient, including any changes in the
(2) All orders, including verbal or- patient’s condition, when the medical
ders, must be dated, timed, and authen- history and physical examination are
ticated promptly by the ordering prac- completed within 30 days before admis-
titioner or by another practitioner who sion or registration. Documentation of
is responsible for the care of the pa- the updated examination must be
tient only if such a practitioner is act-
placed in the patient’s medical record
ing in accordance with State law, in-
within 24 hours after admission or reg-
cluding scope-of-practice laws, hospital
istration, but prior to surgery or a pro-
policies, and medical staff bylaws,
rules, and regulations. cedure requiring anesthesia services.
(3) Hospitals may use pre-printed and (ii) Admitting diagnosis.
electronic standing orders, order sets, (iii) Results of all consultative eval-
and protocols for patient orders only if uations of the patient and appropriate
the hospital: findings by clinical and other staff in-
(i) Establishes that such orders and volved in the care of the patient.
protocols have been reviewed and ap- (iv) Documentation of complications,
proved by the medical staff and the hospital acquired infections, and unfa-
hospital’s nursing and pharmacy lead- vorable reactions to drugs and anes-
ership; thesia.
(ii) Demonstrates that such orders (v) Properly executed informed con-
and protocols are consistent with na- sent forms for procedures and treat-
tionally recognized and evidence-based ments specified by the medical staff, or
guidelines; by Federal or State law if applicable,
(iii) Ensures that the periodic and to require written patient consent.
regular review of such orders and pro-
(vi) All practitioners’ orders, nursing
tocols is conducted by the medical
notes, reports of treatment, medication
staff and the hospital’s nursing and
pharmacy leadership to determine the records, radiology, and laboratory re-
continuing usefulness and safety of the ports, and vital signs and other infor-
orders and protocols; and mation necessary to monitor the pa-
(iv) Ensures that such orders and pro- tient’s condition.
tocols are dated, timed, and authenti- (vii) Discharge summary with out-
cated promptly in the patient’s med- come of hospitalization, disposition of
ical record by the ordering practitioner case, and provisions for follow-up care.
23
§ 482.25 42 CFR Ch. IV (10–1–17 Edition)
(viii) Final diagnosis with comple- (3) Outdated, mislabeled, or other-

tion of medical records within 30 days wise unusable drugs and biologicals
following discharge. must not be available for patient use.
[51 FR 22042, June 17, 1986, as amended at 71 (4) When a pharmacist is not avail-
FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, able, drugs and biologicals must be re-
2007; 77 FR 29074, May 16, 2012] moved from the pharmacy or storage
area only by personnel designated in
§ 482.25 Condition of participation: the policies of the medical staff and
Pharmaceutical services. pharmaceutical service, in accordance
The hospital must have pharma- with Federal and State law.
ceutical services that meet the needs (5) Drugs and biologicals not specifi-
of the patients. The institution must cally prescribed as to time or number
have a pharmacy directed by a reg- of doses must automatically be stopped
istered pharmacist or a drug storage after a reasonable time that is pre-
area under competent supervision. The determined by the medical staff.
medical staff is responsible for devel- (6) Drug administration errors, ad-
oping policies and procedures that min- verse drug reactions, and incompati-
imize drug errors. This function may
bilities must be immediately reported
be delegated to the hospital’s organized
to the attending physician and, if ap-
pharmaceutical service.
propriate, to the hospital’s quality as-
(a) Standard: Pharmacy management
sessment and performance improve-
and administration. The pharmacy or
drug storage area must be adminis- ment program.
tered in accordance with accepted pro- (7) Abuses and losses of controlled
fessional principles. substances must be reported, in accord-
(1) A full-time, part-time, or con- ance with applicable Federal and State
sulting pharmacist must be responsible laws, to the individual responsible for
for developing, supervising, and coordi- the pharmaceutical service, and to the
nating all the activities of the phar- chief executive officer, as appropriate.
macy services. (8) Information relating to drug
(2) The pharmaceutical service must interactions and information of drug
have an adequate number of personnel therapy, side effects, toxicology, dos-
to ensure quality pharmaceutical serv- age, indications for use, and routes of
ices, including emergency services. administration must be available to
(3) Current and accurate records the professional staff.
must be kept of the receipt and disposi- (9) A formulary system must be es-
tion of all scheduled drugs. tablished by the medical staff to assure
(b) Standard: Delivery of services. In quality pharmaceuticals at reasonable
order to provide patient safety, drugs costs.
and biologicals must be controlled and
distributed in accordance with applica- [51 FR 22042, June 17, 1986; 51 FR 27848, Aug.
ble standards of practice, consistent 4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075,
May 16, 2012]
with Federal and State law.
(1) All compounding, packaging, and § 482.26 Condition of participation:
dispensing of drugs and biologicals Radiologic services.
must be under the supervision of a
pharmacist and performed consistent The hospital must maintain, or have
with State and Federal laws. available, diagnostic radiologic serv-
(2)(i) All drugs and biologicals must ices. If therapeutic services are also
be kept in a secure area, and locked provided, they, as well as the diag-
when appropriate. nostic services, must meet profes-
(ii) Drugs listed in Schedules II, III, sionally approved standards for safety
IV, and V of the Comprehensive Drug and personnel qualifications.
Abuse Prevention and Control Act of (a) Standard: Radiologic services. The
1970 must be kept locked within a se- hospital must maintain, or have avail-
cure area. able, radiologic services according to

(iii) Only authorized personnel may needs of the patients.
have access to locked areas.
24
(b) Standard: Safety for patients and hospital must ensure that all labora-
personnel. The radiologic services, par- tory services provided to its patients
ticularly ionizing radiology proce- are performed in a facility certified in
dures, must be free from hazards for accordance with part 493 of this chap-
patients and personnel. ter.
(1) Proper safety precutions must be (a) Standard: Adequacy of laboratory
maintained against radiation hazards. services. The hospital must have labora-
This includes adequate shielding for tory services available, either directly
patients, personnel, and facilities, as or through a contractual agreement
well as appropriate storage, use, and with a certified laboratory that meets
disposal of radioactive materials. requirements of part 493 of this chap-
(2) Periodic inspection of equipment ter.
must be made and hazards identified (1) Emergency laboratory services
must be promptly corrected. must be available 24 hours a day.
(3) Radiation workers must be (2) A written description of services
checked periodically, by the use of ex- provided must be available to the med-
posure meters or badge tests, for ical staff.
amount of radiation exposure. (3) The laboratory must make provi-
(4) Radiologic services must be pro- sion for proper receipt and reporting of
vided only on the order of practitioners tissue specimens.
with clinical privileges or, consistent (4) The medical staff and a patholo-
with State law, of other practitioners gist must determine which tissue speci-
authorized by the medical staff and the mens require a macroscopic (gross) ex-
governing body to order the services. amination and which require both mac-
(c) Standard: Personnel. (1) A qualified roscopic and microscopic examina-
full-time, part-time, or consulting ra- tions.
diologist must supervise the ionizing (b) Standard: Potentially infectious
radiology services and must interpret blood and blood components—(1) Poten-
only those radiologic tests that are de- tially human immunodeficiency virus
termined by the medical staff to re- (HIV) infectious blood and blood compo-
quire a radiologist’s specialized knowl- nents. Potentially HIV infectious blood
edge. For purposes of this section, a ra- and blood components are prior collec-
diologist is a doctor of medicine or os- tions from a donor—
teopathy who is qualified by education (i) Who tested negative at the time of
and experience in radiology. donation but tests reactive for evi-
(2) Only personnel designated as dence of HIV infection on a later dona-
qualified by the medical staff may use tion;
the radiologic equipment and admin- (ii) Who tests positive on the supple-
ister procedures. mental (additional, more specific) test
(d) Standard: Records. Records of or other follow-up testing required by
radiologic services must be main- FDA; and
tained. (iii) For whom the timing of
(1) The radiologist or other practi- seroconversion cannot be precisely es-
tioner who performs radiology services timated.
must sign reports of his or her inter- (2) Potentially hepatitis C virus (HCV)
pretations. infectious blood and blood components.
(2) The hospital must maintain the Potentially HCV infectious blood and
following for at least 5 years: blood components are the blood and
(i) Copies of reports and printouts. blood components identified in 21 CFR
(ii) Films, scans, and other image 610.47.
records, as appropriate. (3) Services furnished by an outside
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. blood collecting establishment. If a hos-
4, 1986] pital regularly uses the services of an
outside blood collecting establishment,
§ 482.27 Condition of participation: it must have an agreement with the
Laboratory services. blood collecting establishment that
The hospital must maintain, or have governs the procurement, transfer, and
available, adequate laboratory services availability of blood and blood compo-
to meet the needs of its patients. The nents. The agreement must require
25
§ 482.27 42 CFR Ch. IV (10–1–17 Edition)
that the blood collecting establishment components held in quarantine as set

notify the hospital— forth at 21 CFR 610.46(b)(2), 610.47(b)(2),
(i) Within 3 calendar days if the blood and 610.48(c)(2).
collecting establishment supplied blood (5) Recordkeeping by the hospital. The
and blood components collected from a hospital must maintain—
donor who tested negative at the time (i) Records of the source and disposi-
of donation but tests reactive for evi- tion of all units of blood and blood
dence of HIV or HCV infection on a components for at least 10 years from
later donation or who is determined to the date of disposition in a manner
be at increased risk for transmitting that permits prompt retrieval; and
HIV or HCV infection; (ii) A fully funded plan to transfer
(ii) Within 45 days of the test, of the these records to another hospital or
results of the supplemental (additional, other entity if such hospital ceases op-
more specific) test for HIV or HCV, as eration for any reason.
relevant, or other follow-up testing re-
(6) Patient notification. If the hospital
quired by FDA; and
has administered potentially HIV or
(iii) Within 3 calendar days after the
HCV infectious blood or blood compo-
blood collecting establishment supplied
nents (either directly through its own
blood and blood components collected
blood collecting establishment or
from an infectious donor, whenever
under an agreement) or released such
records are available, as set forth at 21
blood or blood components to another
CFR 610.48(b)(3).
entity or individual, the hospital must
(4) Quarantine and disposition of blood
take the following actions:
and blood components pending completion
of testing. If the blood collecting estab- (i) Make reasonable attempts to no-
lishment (either internal or under an tify the patient, or to notify the at-
agreement) notifies the hospital of the tending physician or the physician who
reactive HIV or HCV screening test re- ordered the blood or blood component
sults, the hospital must determine the and ask the physician to notify the pa-
disposition of the blood or blood prod- tient, or other individual as permitted
uct and quarantine all blood and blood under paragraph (b)(10) of this section,
components from previous donations in that potentially HIV or HCV infectious
inventory. blood or blood components were trans-
(i) If the blood collecting establish- fused to the patient and that there
ment notifies the hospital that the re- may be a need for HIV or HCV testing
sult of the supplemental (additional, and counseling.
more specific) test or other follow-up (ii) If the physician is unavailable or
testing required by FDA is negative, declines to make the notification,
absent other informative test results, make reasonable attempts to give this
the hospital may release the blood and notification to the patient, legal guard-
blood components from quarantine. ian, or relative.
(ii) If the blood collecting establish- (iii) Document in the patient’s med-
ment notifies the hospital that the re- ical record the notification or attempts
sult of the supplemental, (additional, to give the required notification.
more specific) test or other follow-up (7) Timeframe for notification—(i) For
testing required by FDA is positive, donors tested on or after February 20,
the hospital must— 2008. For notifications resulting from
(A) Dispose of the blood and blood donors tested on or after February 20,
components; and 2008 as set forth at 21 CFR 610.46 and 21
(B) Notify the transfusion bene- CFR 610.47 the notification effort be-
ficiaries as set forth in paragraph (b)(6) gins when the blood collecting estab-
of this section. lishment notifies the hospital that it
(iii) If the blood collecting establish- received potentially HIV or HCV infec-
ment notifies the hospital that the re- tious blood and blood components. The
sult of the supplemental, (additional, hospital must make reasonable at-
more specific) test or other follow-up tempts to give notification over a pe-
testing required by FDA is indetermi- riod of 12 weeks unless—

nate, the hospital must destroy or (A) The patient is located and noti-
label prior collections of blood or blood fied; or
26
(B) The hospital is unable to locate parents or legal guardian must be noti-
the patient and documents in the pa- fied.
tient’s medical record the extenuating (11) Applicability. HCV notification re-
circumstances beyond the hospital’s quirements resulting from donors test-
control that caused the notification ed before February 20, 2008 as set forth
timeframe to exceed 12 weeks. at 21 CFR 610.48 will expire on August
(ii) For donors tested before Feb- 24, 2015.
ruary 20, 2008. For notifications result- (c) General blood safety issues. For
ing from donors tested before February lookback activities only related to new
20, 2008 as set forth at 21 CFR 610.48(b) blood safety issues that are identified
and (c), the notification effort begins after August 24, 2007, hospitals must
when the blood collecting establish- comply with FDA regulations as they
ment notifies the hospital that it re- pertain to blood safety issues in the
ceived potentially HCV infectious following areas:
blood and blood components. The hos- (1) Appropriate testing and quaran-
pital must make reasonable attempts tining of infectious blood and blood
to give notification and must complete components.
the actions within 1 year of the date on (2) Notification and counseling of
which the hospital received notifica- beneficiaries that may have received
tion from the outside blood collecting infectious blood and blood components.
establishment. [57 FR 7136, Feb. 28, 1992, as amended at 61
(8) Content of notification. The notifi- FR 47433, Sept. 9, 1996; 72 FR 48573, Aug. 24,
cation must include the following in- 2007]
formation:
(i) A basic explanation of the need for § 482.28 Condition of participation:
HIV or HCV testing and counseling; Food and dietetic services.
(ii) Enough oral or written informa- The hospital must have organized di-
tion so that an informed decision can etary services that are directed and
be made about whether to obtain HIV staffed by adequate qualified per-
or HCV testing and counseling; and sonnel. However, a hospital that has a
(iii) A list of programs or places contract with an outside food manage-
where the person can obtain HIV or ment company may be found to meet
HCV testing and counseling, including this Condition of participation if the
any requirements or restrictions the company has a dietitian who serves the
program may impose. hospital on a full-time, part-time, or
(9) Policies and procedures. The hos- consultant basis, and if the company
pital must establish policies and proce- maintains at least the minimum stand-
dures for notification and documenta- ards specified in this section and pro-
tion that conform to Federal, State, vides for constant liaison with the hos-
and local laws, including requirements pital medical staff for recommenda-
for the confidentiality of medical tions on dietetic policies affecting pa-
records and other patient information. tient treatment.
(10) Notification to legal representative (a) Standard: Organization. (1) The
or relative. If the patient has been ad- hospital must have a full-time em-
judged incompetent by a State court, ployee who—
the physician or hospital must notify a (i) Serves as director of the food and
legal representative designated in ac- dietetic service;
cordance with State law. If the patient (ii) Is responsible for the daily man-
is competent, but State law permits a agement of the dietary services; and
legal representative or relative to re- (iii) Is qualified by experience or
ceive the information on the patient’s training.
behalf, the physician or hospital must (2) There must be a qualified dieti-
notify the patient or his or her legal tian, full-time, part-time, or on a con-
representative or relative. For possible sultant basis.
HIV infectious transfusion bene- (3) There must be administrative and
ficiaries that are deceased, the physi- technical personnel competent in their
cian or hospital must inform the de- respective duties.

ceased patient’s legal representative or (b) Standard: Diets. Menus must meet
relative. If the patient is a minor, the the needs of the patients.
27
§ 482.30 42 CFR Ch. IV (10–1–17 Edition)
(1) Individual patient nutritional (A) Established by the local medical

needs must be met in accordance with society and some or all of the hospitals
recognized dietary practices. in the locality; or
(2) All patient diets, including thera- (B) Established in a manner approved
peutic diets, must be ordered by a prac- by CMS.
titioner responsible for the care of the (2) If, because of the small size of the
patient, or by a qualified dietitian or institution, it is impracticable to have
qualified nutrition professional as au- a properly functioning staff com-
thorized by the medical staff and in ac- mittee, the UR committee must be es-
cordance with State law governing di- tablished as specified in paragraph
etitians and nutrition professionals. (b)(1)(ii) of this section.
(3) A current therapeutic diet manual (3) The committee’s or group’s re-
approved by the dietitian and medical views may not be conducted by any in-
staff must be readily available to all dividual who—
medical, nursing, and food service per- (i) Has a direct financial interest (for
sonnel. example, an ownership interest) in that
[51 FR 22042, June 17, 1986, as amended at 79 hospital; or
FR 27154, May 12, 2014] (ii) Was professionally involved in
the care of the patient whose case is
§ 482.30 Condition of participation: being reviewed.
Utilization review.
(c) Standard: Scope and frequency of
The hospital must have in effect a review. (1) The UR plan must provide
utilization review (UR) plan that pro- for review for Medicare and Medicaid
vides for review of services furnished patients with respect to the medical
by the institution and by members of necessity of—
the medical staff to patients entitled (i) Admissions to the institution;
to benefits under the Medicare and (ii) The duration of stays; and
Medicaid programs. (iii) Professional services furnished,
(a) Applicability. The provisions of
including drugs and biologicals.
this section apply except in either of
(2) Review of admissions may be per-
the following circumstances:
formed before, at, or after hospital ad-
(1) A Utilization and Quality Control
mission.
Quality Improvement Organization
(QIO) has assumed binding review for (3) Except as specified in paragraph
the hospital. (e) of this section, reviews may be con-
(2) CMS has determined that the UR ducted on a sample basis.
procedures established by the State (4) Hospitals that are paid for inpa-
under title XIX of the Act are superior tient hospital services under the pro-
to the procedures required in this sec- spective payment system set forth in
tion, and has required hospitals in that part 412 of this chapter must conduct
State to meet the UR plan require- review of duration of stays and review
ments under §§ 456.50 through 456.245 of of professional services as follows:
this chapter. (i) For duration of stays, these hos-
(b) Standard: Composition of utilization pitals need review only cases that they
review committee. A UR committee con- reasonably assume to be outlier cases
sisting of two or more practitioners based on extended length of stay, as de-
must carry out the UR function. At scribed in § 412.80(a)(1)(i) of this chap-
least two of the members of the com- ter; and
mittee must be doctors of medicine or (ii) For professional services, these
osteopathy. The other members may be hospitals need review only cases that
any of the other types of practitioners they reasonably assume to be outlier
specified in § 482.12(c)(1). cases based on extraordinarily high
(1) Except as specified in paragraphs costs, as described in § 412.80(a)(1)(ii) of
(b) (2) and (3) of this section, the UR this chapter.
committee must be one of the fol- (d) Standard: Determination regarding
lowing: admissions or continued stays. (1) The de-
(i) A staff committee of the institu- termination that an admission or con-

tion; tinued stay is not medically nec-
(ii) A group outside the institution— essary—
28
(i) May be made by one member of mote the most efficient use of avail-
the UR committee if the practitioner able health facilities and services.
or practitioners responsible for the
care of the patient, as specified of § 482.41 Condition of participation:
§ 482.12(c), concur with the determina- Physical environment.
tion or fail to present their views when The hospital must be constructed, ar-
afforded the opportunity; and ranged, and maintained to ensure the
(ii) Must be made by at least two safety of the patient, and to provide fa-
members of the UR committee in all cilities for diagnosis and treatment and
other cases. for special hospital services appro-
(2) Before making a determination priate to the needs of the community.
that an admission or continued stay is (a) Standard: Buildings. The condition
not medically necessary, the UR com- of the physical plant and the overall
mittee must consult the practitioner hospital environment must be devel-
or practitioners responsible for the oped and maintained in such a manner
care of the patient, as specified in that the safety and well-being of pa-
§ 482.12(c), and afford the practitioner tients are assured.
or practitioners the opportunity to (1) There must be emergency power
present their views. and lighting in at least the operating,
recovery, intensive care, and emer-
(3) If the committee decides that ad-
gency rooms, and stairwells. In all
mission to or continued stay in the
other areas not serviced by the emer-
hospital is not medically necessary,
gency supply source, battery lamps and
written notification must be given, no
flashlights must be available.
later than 2 days after the determina-
(2) There must be facilities for emer-
tion, to the hospital, the patient, and
gency gas and water supply.
the practitioner or practitioners re-
(b) Standard: Life safety from fire. (1)
sponsible for the care of the patient, as
Except as otherwise provided in this
specified in § 482.12(c);
section—
(e) Standard: Extended stay review. (1)
(i) The hospital must meet the appli-
In hospitals that are not paid under the
cable provisions and must proceed in
prospective payment system, the UR
accordance with the Life Safety Code
committee must make a periodic re-
(NFPA 101 and Tentative Interim
view, as specified in the UR plan, of
Amendments TIA 12–1, TIA 12–2, TIA
each current inpatient receiving hos-
12–3, and TIA 12–4.) Outpatient surgical
pital services during a continuous pe-
departments must meet the provisions
riod of extended duration. The sched-
applicable to Ambulatory Health Care
uling of the periodic reviews may— Occupancies, regardless of the number
(i) Be the same for all cases; or of patients served.
(ii) Differ for different classes of (ii) Notwithstanding paragraph
cases. (b)(1)(i) of this section, corridor doors
(2) In hospitals paid under the pro- and doors to rooms containing flam-
spective payment system, the UR com- mable or combustible materials must
mittee must review all cases reason- be provided with positive latching
ably assumed by the hospital to be hardware. Roller latches are prohibited
outlier cases because the extended on such doors.
length of stay exceeds the threshold (2) In consideration of a rec-
criteria for the diagnosis, as described ommendation by the State survey
in § 412.80(a)(1)(i). The hospital is not agency or Accrediting Organization or
required to review an extended stay at the discretion of the Secretary, may
that does not exceed the outlier thresh- waive, for periods deemed appropriate,
old for the diagnosis. specific provisions of the Life Safety
(3) The UR committee must make the Code, which would result in unreason-
periodic review no later than 7 days able hardship upon a hospital, but only
after the day required in the UR plan. if the waiver will not adversely affect
(f) Standard: Review of professional the health and safety of the patients.
services. The committee must review (3) The provisions of the Life Safety
professional services provided, to de- Code do not apply in a State where
termine medical necessity and to pro- CMS finds that a fire and safety code
29
§ 482.41 42 CFR Ch. IV (10–1–17 Edition)
imposed by State law adequately pro- unreasonable hardship for the hospital,
tects patients in hospitals. CMS may waive specific provisions of
(4) The hospital must have proce- the Health Care Facilities Code, but
dures for the proper routine storage only if the waiver does not adversely
and prompt disposal of trash. affect the health and safety of patients.
(5) The hospital must have written (d) Standard: Facilities. The hospital
fire control plans that contain provi- must maintain adequate facilities for
sions for prompt reporting of fires; exits services.
tinguishing fires; protection of pa- (1) Diagnostic and therapeutic facili-
tients, personnel and guests; evacu- ties must be located for the safety of
ation; and cooperation with fire fight- patients.
ing authorities. (2) Facilities, supplies, and equip-
(6) The hospital must maintain writ- ment must be maintained to ensure an
ten evidence of regular inspection and acceptable level of safety and quality.
approval by State or local fire control (3) The extent and complexity of fa-
agencies. cilities must be determined by the
(7) A hospital may install alcohol- services offered.
based hand rub dispensers in its facil- (4) There must be proper ventilation,
ity if the dispensers are installed in a light, and temperature controls in
manner that adequately protects pharmaceutical, food preparation, and
against inappropriate access; other appropriate areas.
(8) When a sprinkler system is shut
(e) The standards incorporated by
down for more than 10 hours, the hos-
pital must:
for incorporation by reference by the
(i) Evacuate the building or portion
Director of the Office of the Federal
of the building affected by the system
Register in accordance with 5 U.S.C.
outage until the system is back in
552(a) and 1 CFR part 51. You may in-
service, or
spect a copy at the CMS Information
(ii) Establish a fire watch until the
Resource Center, 7500 Security Boule-
system is back in service.
vard, Baltimore, MD or at the National
(9) Buildings must have an outside
Archives and Records Administration
window or outside door in every sleep-
(NARA). For information on the avail-
ing room, and for any building con-
ability of this material at NARA, call
structed after July 5, 2016 the sill
202–741–6030, or go to: http://
height must not exceed 36 inches above
www.archives.gov/federallregister/
the floor. Windows in atrium walls are
codeloflfederallregulations/
considered outside windows for the pur-
ibrllocations.html. If any changes in
poses of this requirement.
this edition of the Code are incor-
(i) The sill height requirement does
porated by reference, CMS will publish
not apply to newborn nurseries and
a document in the FEDERAL REGISTER
rooms intended for occupancy for less
to announce the changes.
than 24 hours.
(1) National Fire Protection Associa-
(ii) The sill height in special nursing
tion, 1 Batterymarch Park, Quincy,
care areas of new occupancies must not
MA 02169, www.nfpa.org, 1.617.770.3000.
exceed 60 inches.
(c) Standard: Building safety. Except (i) NFPA 99, Standards for Health
as otherwise provided in this section, Care Facilities Code of the National
the hospital must meet the applicable Fire Protection Association 99, 2012
provisions and must proceed in accord- edition, issued August 11, 2011.
ance with the Health Care Facilities (ii) TIA 12–2 to NFPA 99, issued Au-
Code (NFPA 99 and Tentative Interim gust 11, 2011.
Amendments TIA 12–2, TIA 12–3, TIA (iii) TIA 12–3 to NFPA 99, issued Au-
12–4, TIA 12–5 and TIA 12–6). gust 9, 2012.
(1) Chapters 7, 8, 12, and 13 of the (iv) TIA 12–4 to NFPA 99, issued
adopted Health Care Facilities Code do March 7, 2013.
not apply to a hospital. (v) TIA 12–5 to NFPA 99, issued Au-
(2) If application of the Health Care gust 1, 2013.

Facilities Code required under para- (vi) TIA 12–6 to NFPA 99, issued
graph (c) of this section would result in March 3, 2014.
30
(vii) NFPA 101, Life Safety Code, 2012 to all patients. The hospital’s policies
edition, issued August 11, 2011; and procedures must be specified in
(viii) TIA 12–1 to NFPA 101, issued writing.
August 11, 2011. (a) Standard: Identification of patients
(ix) TIA 12–2 to NFPA 101, issued Oc- in need of discharge planning. The hos-
tober 30, 2012. pital must identify at an early stage of
(x) TIA 12–3 to NFPA 101, issued Oc- hospitalization all patients who are
tober 22, 2013. likely to suffer adverse health con-
(xi) TIA 12–4 to NFPA 101, issued Oc- sequences upon discharge if there is no
tober 22, 2013. adequate discharge planning.
(2) [Reserved] (b) Standard: Discharge planning eval-
[51 FR 22042, June 17, 1986, as amended at 53 uation. (1) The hospital must provide a
FR 11509, Apr. 7, 1988; 68 FR 1386, Jan. 10, discharge planning evaluation to the
2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, patients identified in paragraph (a) of
Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR this section, and to other patients upon
26899, May 4, 2016; 81 FR 42548, June 30, 2016]
the patient’s request, the request of a
§ 482.42 Condition of participation: In- person acting on the patient’s behalf,
fection control. or the request of the physician.
The hospital must provide a sanitary (2) A registered nurse, social worker,
environment to avoid sources and or other appropriately qualified per-
transmission of infections and commu- sonnel must develop, or supervise the
nicable diseases. There must be an ac- development of, the evaluation.
tive program for the prevention, con- (3) The discharge planning evaluation
trol, and investigation of infections must include an evaluation of the like-
and communicable diseases. lihood of a patient needing post- hos-
(a) Standard: Organization and poli- pital services and of the availability of
cies. A person or persons must be des- the services.
ignated as infection control officer or (4) The discharge planning evaluation
officers to develop and implement poli- must include an evaluation of the like-
cies governing control of infections and lihood of a patient’s capacity for self-
communicable diseases. The infection care or of the possibility of the patient
control officer or officers must develop being cared for in the environment
a system for identifying, reporting, in- from which he or she entered the hos-
vestigating, and controlling infections pital.
and communicable diseases of patients (5) The hospital personnel must com-
and personnel. plete the evaluation on a timely basis
(b) Standard: Responsibilities of chief so that appropriate arrangements for
executive officer, medical staff, and direc- post-hospital care are made before dis-
tor of nursing services. The chief execu- charge, and to avoid unnecessary
tive officer, the medical staff, and the delays in discharge.
director of nursing services must— (6) The hospital must include the dis-
(1) Ensure that the hospital-wide charge planning evaluation in the pa-
quality assessment and performance tient’s medical record for use in estab-
improvement (QAPI) program and lishing an appropriate discharge plan
training programs address problems and must discuss the results of the
identified by the infection control offi- evaluation with the patient or indi-
cer or officers; and vidual acting on his or her behalf.
(2) Be responsible for the implemen- (c) Standard: Discharge plan. (1) A reg-
tation of successful corrective action istered nurse, social worker, or other
plans in affected problem areas. appropriately qualified personnel must
[51 FR 22042, June 17, 1986, as amended at 77 develop, or supervise the development
FR 29075, May 16, 2012; 79 FR 10396, Feb. 25, of, a discharge plan if the discharge
2014] planning evaluation indicates a need
for a discharge plan.
§ 482.43 Condition of participation: (2) In the absence of a finding by the
Discharge planning. hospital that a patient needs a dis-

The hospital must have in effect a charge plan, the patient’s physician
discharge planning process that applies may request a discharge plan. In such a
31
§ 482.45 42 CFR Ch. IV (10–1–17 Edition)
case, the hospital must develop a dis- terest in a hospital under Medicare. Fi-
charge plan for the patient. nancial interests that are disclosable
(3) The hospital must arrange for the under Medicare are determined in ac-
initial implementation of the patient’s cordance with the provisions of part
discharge plan. 420, subpart C, of this chapter.
(4) The hospital must reassess the pa- (d) Standard: Transfer or referral. The
tient’s discharge plan if there are fac- hospital must transfer or refer pa-
tors that may affect continuing care tients, along with necessary medical
needs or the appropriateness of the dis- information, to appropriate facilities,
charge plan. agencies, or outpatient services, as
(5) As needed, the patient and family needed, for followup or ancillary care.
members or interested persons must be (e) Standard: Reassessment. The hos-
counseled to prepare them for post-hospital must reassess its discharge plan-
pital care. ning process on an on-going basis. The
(6) The hospital must include in the reassessment must include a review of
discharge plan a list of HHAs or SNFs discharge plans to ensure that they are
that are available to the patient, that responsive to discharge needs.
are participating in the Medicare pro- [59 FR 64152, Dec. 13, 1994, as amended at 69
gram, and that serve the geographic FR 49268, Aug. 11, 2004]
area (as defined by the HHA) in which
the patient resides, or in the case of a § 482.45 Condition of participation:
SNF, in the geographic area requested Organ, tissue, and eye procurement.
by the patient. HHAs must request to (a) Standard: Organ procurement re-
be listed by the hospital as available. sponsibilities. The hospital must have
(i) This list must only be presented and implement written protocols that:
to patients for whom home health care (1) Incorporate an agreement with an
or post-hospital extended care services OPO designated under part 486 of this
are indicated and appropriate as deter- chapter, under which it must notify, in
mined by the discharge planning eval- a timely manner, the OPO or a third
uation. party designated by the OPO of individ-
(ii) For patients enrolled in managed uals whose death is imminent or who
care organizations, the hospital must have died in the hospital. The OPO de-
indicate the availability of home termines medical suitability for organ
health and posthospital extended care donation and, in the absence of alter-
services through individuals and enti- native arrangements by the hospital,
ties that have a contract with the man- the OPO determines medical suit-
aged care organizations. ability for tissue and eye donation,
(iii) The hospital must document in using the definition of potential tissue
the patient’s medical record that the and eye donor and the notification pro-
list was presented to the patient or to tocol developed in consultation with
the individual acting on the patient’s the tissue and eye banks identified by
behalf. the hospital for this purpose;
(7) The hospital, as part of the dis- (2) Incorporate an agreement with at
charge planning process, must inform least one tissue bank and at least one
the patient or the patient’s family of eye bank to cooperate in the retrieval,
their freedom to choose among partici- processing, preservation, storage and
pating Medicare providers of distribution of tissues and eyes, as may
posthospital care services and must, be appropriate to assure that all usable
when possible, respect patient and fam- tissues and eyes are obtained from po-
ily preferences when they are ex- tential donors, insofar as such an
pressed. The hospital must not specify agreement does not interfere with
or otherwise limit the qualified pro- organ procurement;
viders that are available to the patient. (3) Ensure, in collaboration with the
(8) The discharge plan must identify designated OPO, that the family of
any HHA or SNF to which the patient each potential donor is informed of its
is referred in which the hospital has a options to donate organs, tissues, or
disclosable financial interest, as speci- eyes or to decline to donate. The indi-

fied by the Secretary, and any HHA or vidual designated by the hospital to
SNF that has a disclosable financial in- initiate the request to the family must
32
be an organ procurement representa- Subpart D—Optional Hospital

tive or a designated requestor. A des- Services
ignated requestor is an individual who
has completed a course offered or ap- § 482.51 Condition of participation:
proved by the OPO and designed in con- Surgical services.
junction with the tissue and eye bank If the hospital provides surgical serv-
community in the methodology for ap- ices, the services must be well orga-
proaching potential donor families and nized and provided in accordance with
requesting organ or tissue donation; acceptable standards of practice. If
(4) Encourage discretion and sensi- outpatient surgical services are offered
tivity with respect to the cir- the services must be consistent in qual-
cumstances, views, and beliefs of the ity with inpatient care in accordance
families of potential donors; with the complexity of services offered.
(5) Ensure that the hospital works (a) Standard: Organization and staff-
cooperatively with the designated OPO, ing. The organization of the surgical
tissue bank and eye bank in educating services must be appropriate to the
staff on donation issues, reviewing scope of the services offered.
death records to improve identification (1) The operating rooms must be su-
of potential donors, and maintaining pervised by an experienced registered
potential donors while necessary test- nurse or a doctor of medicine or oste-
ing and placement of potential donated opathy.
organs, tissues, and eyes take place. (2) Licensed practical nurses (LPNs)
and surgical technologists (operating
(b) Standard: Organ transplantation re-
room technicians) may serve as ‘‘scrub
sponsibilities. (1) A hospital in which
nurses’’ under the supervision of a reg-
organ transplants are performed must
istered nurse.
be a member of the Organ Procurement
(3) Qualified registered nurses may
and Transplantation Network (OPTN) perform circulating duties in the oper-
established and operated in accordance ating room. In accordance with appli-
with section 372 of the Public Health cable State laws and approved medical
Service (PHS) Act (42 U.S.C. 274) and staff policies and procedures, LPNs and
abide by its rules. The term ‘‘rules of surgical technologists may assist in
the OPTN’’ means those rules provided circulatory duties under the
for in regulations issued by the Sec- surpervision of a qualified registered
retary in accordance with section 372 of nurse who is immediately available to
the PHS Act which are enforceable respond to emergencies.
under 42 CFR 121.10. No hospital is con- (4) Surgical privileges must be delin-
sidered to be out of compliance with eated for all practitioners performing
section 1138(a)(1)(B) of the Act, or with surgery in accordance with the com-
the requirements of this paragraph, un- petencies of each practitioner. The sur-
less the Secretary has given the OPTN gical service must maintain a roster of
formal notice that he or she approves practitioners specifying the surgical
the decision to exclude the hospital privileges of each practitioner.
from the OPTN and has notified the (b) Standard: Delivery of service. Sur-
hospital in writing. gical services must be consistent with
(2) For purposes of these standards, needs and resources. Policies governing
the term ‘‘organ’’ means a human kid- surgical care must be designed to as-
ney, liver, heart, lung, or pancreas. sure the achievement and maintenance
(3) If a hospital performs any type of of high standards of medical practice
transplants, it must provide organ- and patient care.
transplant-related data, as requested (1) Prior to surgery or a procedure re-
by the OPTN, the Scientific Registry, quiring anesthesia services and except
and the OPOs. The hospital must also in the case of emergencies:
provide such data directly to the De- (i) A medical history and physical ex-
amination must be completed and doc-
partment when requested by the Sec-

umented no more than 30 days before
retary.
or 24 hours after admission or registra-
[63 FR 33875, June 22, 1998] tion.
33
§ 482.52 42 CFR Ch. IV (10–1–17 Edition)
(ii) An updated examination of the (5) An anesthesiologist’s assistant, as

patient, including any changes in the defined in § 410.69(b) of this chapter,
patient’s condition, must be completed who is under the supervision of an an-
and documented within 24 hours after esthesiologist who is immediately
admission or registration when the available if needed.
medical history and physical examina- (b) Standard: Delivery of services. An-
tion are completed within 30 days be- esthesia services must be consistent
fore admission or registration. with needs and resources. Policies on
(2) A properly executed informed con- anesthesia procedures must include the
sent form for the operation must be in delineation of preanesthesia and post
the patient’s chart before surgery, ex- anesthesia responsibilities. The poli-
cept in emergencies. cies must ensure that the following are
(3) The following equipment must be provided for each patient:
available to the operating room suites: (1) A preanesthesia evaluation com-
call-in-system, cardiac monitor, resus- pleted and documented by an indi-
citator, defibrillator, aspirator, and vidual qualified to administer anes-
tracheotomy set. thesia, as specified in paragraph (a) of
(4) There must be adequate provi- this section, performed within 48 hours
sions for immediate post-operative prior to surgery or a procedure requir-
care. ing anesthesia services.
(5) The operating room register must (2) An intraoperative anesthesia
be complete and up-to-date. record.
(6) An operative report describing (3) A postanesthesia evaluation com-
techniques, findings, and tissues re- pleted and documented by an indi-
moved or altered must be written or vidual qualified to administer anes-
dictated immediately following sur- thesia, as specified in paragraph (a) of
gery and signed by the surgeon. this section, no later than 48 hours
after surgery or a procedure requiring
[51 FR 22042, June 17, 1986, as amended at 72 anesthesia services. The postanesthesia
FR 66933, Nov. 27, 2007] evaluation for anesthesia recovery
must be completed in accordance with
§ 482.52 Condition of participation: An-
esthesia services. State law and with hospital policies
and procedures that have been ap-
If the hospital furnishes anesthesia proved by the medical staff and that
services, they must be provided in a reflect current standards of anesthesia
well-organized manner under the direc- care.
tion of a qualified doctor of medicine (c) Standard: State exemption. (1) A
or osteopathy. The service is respon- hospital may be exempted from the re-
sible for all anesthesia administered in quirement for physician supervision of
the hospital. CRNAs as described in paragraph (a)(4)
(a) Standard: Organization and staff- of this section, if the State in which
ing. The organization of anesthesia the hospital is located submits a letter
services must be appropriate to the to CMS signed by the Governor, fol-
scope of the services offered. Anes- lowing consultation with the State’s
thesia must be administered only by— Boards of Medicine and Nursing, re-
(1) A qualified anesthesiologist; questing exemption from physician su-
(2) A doctor of medicine or osteop- pervision of CRNAs. The letter from
athy (other than an anesthesiologist); the Governor must attest that he or
(3) A dentist, oral surgeon, or podia- she has consulted with State Boards of
trist who is qualified to administer an- Medicine and Nursing about issues re-
esthesia under State law; lated to access to and the quality of
(4) A certified registered nurse anes- anesthesia services in the State and
thetist (CRNA), as defined in § 410.69(b) has concluded that it is in the best in-
of this chapter, who, unless exempted terests of the State’s citizens to opt-
in accordance with paragraph (c)of this out of the current physician super-
section, is under the supervision of the vision requirement, and that the opt-
operating practitioner or of an anes- out is consistent with State law.

thesiologist who is immediately avail- (2) The request for exemption and
able if needed; or recognition of State laws, and the
34
withdrawal of the request may be sub- (1) The hospital must maintain cop-
mitted at any time, and are effective ies of nuclear medicine reports for at
upon submission. least 5 years.
(2) The practitioner approved by the
FR 33900, July 31, 1992; 66 FR 56769, Nov. 13, medical staff to interpret diagnostic
2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, procedures must sign and date the in-
Nov. 27, 2007] terpretation of these tests.
(3) The hospital must maintain
§ 482.53 Condition of participation: records of the receipt and disposition of
Nuclear medicine services. radiopharmaceuticals.
If the hospital provides nuclear medi- (4) Nuclear medicine services must be
cine services, those services must meet ordered only by practitioner whose
the needs of the patients in accordance scope of Federal or State licensure and
with acceptable standards of practice. whose defined staff privileges allow
(a) Standard: Organization and staff- such referrals.
ing. The organization of the nuclear [51 FR 22042, June 17, 1986, as amended at 57
medicine service must be appropriate FR 7136, Feb. 28, 1992; 79 FR 27154, May 12,
to the scope and complexity of the 2014]
services offered.
(1) There must be a director who is a § 482.54 Condition of participation:
doctor of medicine or osteopathy quali- Outpatient services.
fied in nuclear medicine. If the hospital provides outpatient
(2) The qualifications, training, func- services, the services must meet the
tions, and responsibilities of nuclear needs of the patients in accordance
medicine personnel must be specified with acceptable standards of practice.
by the service director and approved by (a) Standard: Organization. Outpatient
the medical staff. services must be appropriately orga-
(b) Standard: Delivery of service. Ra- nized and integrated with inpatient
dioactive materials must be prepared, services.
labeled, used, transported, stored, and (b) Standard: Personnel. The hospital
disposed of in accordance with accept- must—
able standards of practice. (1) Assign one or more individuals to
(1) In-house preparation of radio- be responsible for outpatient services.
pharmaceuticals is by, or under the su- (2) Have appropriate professional and
pervision of, an appropriately trained nonprofessional personnel available at
registered pharmacist or a doctor of each location where outpatient serv-
medicine or osteopathy. ices are offered, based on the scope and
(2) There is proper storage and dis- complexity of outpatient services.
posal of radioactive material. (c) Standard: Orders for outpatient
(3) If laboratory tests are performed services. Outpatient services must be
in the nuclear medicine service, the ordered by a practitioner who meets
service must meet the applicable re- the following conditions:
quirement for laboratory services spec- (1) Is responsible for the care of the
ified in § 482.27. patient.
(c) Standard: Facilities. Equipment (2) Is licensed in the State where he
and supplies must be appropriate for or she provides care to the patient.
the types of nuclear medicine services (3) Is acting within his or her scope of
offered and must be maintained for safe practice under State law.
and efficient performance. The equip- (4) Is authorized in accordance with
ment must be— State law and policies adopted by the
(1) Maintained in safe operating con- medical staff, and approved by the gov-
dition; and erning body, to order the applicable
(2) Inspected, tested, and calibrated outpatient services. This applies to the
at least annually by qualified per- following:
sonnel. (i) All practitioners who are ap-
(d) Standard: Records. The hospital pointed to the hospital’s medical staff
must maintain signed and dated re- and who have been granted privileges
ports of nuclear medicine interpreta- to order the applicable outpatient serv-
tions, consultations, and procedures. ices.
35
§ 482.55 42 CFR Ch. IV (10–1–17 Edition)
(ii) All practitioners not appointed to therapy assistants, speech-language pa-

the medical staff, but who satisfy the thologists, or audiologists as defined in
above criteria for authorization by the part 484 of this chapter.
medical staff and the hospital for or- (b) Standard: Delivery of services. Serv-
dering the applicable outpatient services must only be provided under the
ices for their patients. orders of a qualified and licensed prac-
[51 FR 22042, June 17, 1986, as amended at 77 titioner who is responsible for the care
FR 29075, May 16, 2012; 79 FR 27154, May 12, of the patient, acting within his or her
2014] scope of practice under State law, and
who is authorized by the hospital’s
§ 482.55 Condition of participation: medical staff to order the services in
Emergency services. accordance with hospital policies and
The hospital must meet the emer- procedures and State laws.
gency needs of patients in accordance (1) All rehabilitation services orders
with acceptable standards of practice. must be documented in the patient’s
(a) Standard: Organization and direc- medical record in accordance with the
tion. If emergency services are provided requirements at § 482.24.
at the hospital— (2) The provision of care and the per-
(1) The services must be organized sonnel qualifications must be in ac-
under the direction of a qualified mem- cordance with national acceptable
ber of the medical staff; standards of practice and must also
(2) The services must be integrated meet the requirements of § 409.17 of this
with other departments of the hospital; chapter.
(3) The policies and procedures gov-
erning medical care provided in the [51 FR 22042, June 17, 1986, as amended at 72
FR 66406, Nov. 27, 2007; 75 FR 50418, Aug. 16,
emergency service or department are
2010]
established by and are a continuing re-
sponsibility of the medical staff. § 482.57 Condition of participation:
(b) Standard: Personnel. (1) The emer- Respiratory care services.
gency services must be supervised by a
qualified member of the medical staff. The hospital must meet the needs of
(2) There must be adequate medical the patients in accordance with accept-
and nursing personnel qualified in able standards of practice. The fol-
emergency care to meet the written lowing requirements apply if the hos-
emergency procedures and needs an- pital provides respiratory care service.
ticipated by the facility. (a) Standard: Organization and Staff-
ing. The organization of the respiratory
§ 482.56 Condition of participation: Re- care services must be appropriate to
habilitation services. the scope and complexity of the serv-
If the hospital provides rehabilita- ices offered.
tion, physical therapy, occupational (1) There must be a director of res-
therapy, audiology, or speech pathol- piratory care services who is a doctor
ogy services, the services must be orga- of medicine or osteopathy with the
nized and staffed to ensure the health knowledge experience, and capabilities
and safety of patients. to supervise and administer the service
(a) Standard: Organization and staff- properly. The director may serve on ei-
ing. The organization of the service ther a full-time or part-time basis.
must be appropriate to the scope of the (2) There must be adequate numbers
services offered. of respiratory therapists, respiratory
(1) The director of the services must therapy technicians, and other per-
have the necessary knowledge, experi- sonnel who meet the qualifications
ence, and capabilities to properly su- specified by the medical staff, con-
pervise and administer the services. sistent with State law.
(2) Physical therapy, occupational (b) Standard: Delivery of Services.
therapy, speech-language pathology or Services must be delivered in accord-
audiology services, if provided, must be ance with medical staff directives.
provided by qualified physical thera- (1) Personnel qualified to perform

pists, physical therapist assistants, oc- specific procedures and the amount of
cupational therapists, occupational supervision required for personnel to
36
carry out specific procedures must be cility requirements contained in sub-

designated in writing. part B of part 483 of this chapter.
(2) If blood gases or other laboratory (1) Resident rights (§ 483.10(b)(7),
tests are performed in the respiratory (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2), (e)(4),
care unit, the unit must meet the ap- (f)(4)(ii), (f)(4)(iii), (f)(9), (h), (g)(8),
plicable requirements for laboratory (g)(17), and (g)(18) introductory text.
services specified in § 482.27. (2) Admission, transfer, and discharge
(3) Services must only be provided rights (§ 483.5 definition of transfer and
under the orders of a qualified and li- discharge, § 483.15(c)(1), (c)(2)(i),
censed practitioner who is responsible (c)(2)(ii), (c)(3), (c)(4), (c)(5), and (c)(7)).
for the care of the patient, acting with- (3) Freedom from abuse, neglect, and
in his or her scope of practice under exploitation (§ 483.12(a)(1), (a)(2),
State law, and who is authorized by the (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2),
hospital’s medical staff to order the (c)).
services in accordance with hospital (4) Patient activities (§ 483.24(c)).
policies and procedures and State laws. (5) Social services (§ 483.40(d) and
(4) All respiratory care services or- 483.70(p)).
ders must be documented in the pa- (6) Discharge planning (§ 483.20(e)).
tient’s medical record in accordance (7) Specialized rehabilitative services
with the requirements at § 482.24. (§ 483.65).
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug.
(8) Dental services (§ 483.55).
4, 1986, as amended at 57 FR 7136, Feb. 28, [72 FR 60788, Oct. 26, 2007. Redesignated at 79
1992; 75 FR 50418, Aug. 16, 2010] FR 27155, May 12, 2014, as amended at 81 FR
68847, Oct. 4, 2016; 82 FR 32258, July 13, 2017]
§ 482.58 Special requirements for hos-
pital providers of long-term care
services (‘‘swing-beds’’). Subpart E—Requirements for
A hospital that has a Medicare pro-
Specialty Hospitals
vider agreement must meet the fol-
lowing requirements in order to be SOURCE: 72 FR 15273, Mar. 30, 2007, unless
granted an approval from CMS to pro- otherwise noted.
vide post-hospital extended care serv- § 482.60 Special provisions applying to
ices, as specified in § 409.30 of this chap- psychiatric hospitals.
ter, and be reimbursed as a swing-bed
hospital, as specified in § 413.114 of this Psychiatric hospital must—
chapter: (a) Be primarily engaged in pro-
(a) Eligibility. A hospital must meet viding, by or under the supervision of a
the following eligibility requirements: doctor of medicine or osteopathy, psy-
(1) The facility has fewer than 100 chiatric services for the diagnosis and
hospital beds, excluding beds for treatment of mentally ill persons;
newborns and beds in intensive care (b) Meet the conditions of participa-
type inpatient units (for eligibility of tion specified in §§ 482.1 through 482.23
hospitals with distinct parts electing and §§ 482.25 through 482.57;
the optional reimbursement method, (c) Maintain clinical records on all
see § 413.24(d)(5) of this chapter). patients, including records sufficient to
(2) The hospital is located in a rural permit CMS to determine the degree
area. This includes all areas not delin- and intensity of treatment furnished to
eated as ‘‘urbanized’’ areas by the Cen- Medicare beneficiaries, as specified in
sus Bureau, based on the most recent § 482.61; and
census. (d) Meet the staffing requirements
(3) The hospital does not have in ef- specified in § 482.62.
fect a 24-hour nursing waiver granted [72 FR 60788, Oct. 26, 2007]
under § 488.54(c) of this chapter.
(4) The hospital has not had a swing- § 482.61 Condition of participation:
bed approval terminated within the Special medical record require-
two years previous to application. ments for psychiatric hospitals.
(b) Skilled nursing facility services. The The medical records maintained by a
facility is substantially in compliance psychiatric hospital must permit deter-
with the following skilled nursing fa- mination of the degree and intensity of
37
§ 482.62 42 CFR Ch. IV (10–1–17 Edition)
the treatment provided to individuals (iv) The responsibilities of each mem-

who are furnished services in the insti- ber of the treatment team; and
tution. (v) Adequate documentation to jus-
(a) Standard: Development of assess- tify the diagnosis and the treatment
ment/diagnostic data. Medical records and rehabilitation activities carried
must stress the psychiatric compo- out.
nents of the record, including history (2) The treatment received by the pa-
of findings and treatment provided for tient must be documented in such a
the psychiatric condition for which the way to assure that all active thera-
patient is hospitalized. peutic efforts are included.
(1) The identification data must in- (d) Standard: Recording progress.
clude the patient’s legal status. Progress notes must be recorded by the
(2) A provisional or admitting diag- doctor of medicine or osteopathy re-
nosis must be made on every patient at sponsible for the care of the patient as
the time of admission, and must in- specified in § 482.12(c), nurse, social
clude the diagnoses of intercurrent dis- worker and, when appropriate, others
eases as well as the psychiatric diag- significantly involved in active treat-
noses. ment modalities. The frequency of
(3) The reasons for admission must be progress notes is determined by the
clearly documented as stated by the condition of the patient but must be
patient and/or others significantly in- recorded at least weekly for the first 2
volved. months and at least once a month
(4) The social service records, includ- thereafter and must contain rec-
ing reports of interviews with patients, ommendations for revisions in the
family members, and others, must pro- treatment plan as indicated as well as
vide an assessment of home plans and precise assessment of the patient’s
family attitudes, and community re- progress in accordance with the origi-
source contacts as well as a social his- nal or revised treatment plan.
tory. (e) Standard: Discharge planning and
(5) When indicated, a complete neuro- discharge summary. The record of each
logical examination must be recorded patient who has been discharged must
at the time of the admission physical have a discharge summary that in-
examination. cludes a recapitulation of the patient’s
(b) Standard: Psychiatric evaluation. hospitalization and recommendations
Each patient must receive a psy- from appropriate services concerning
chiatric evaluation that must— follow-up or aftercare as well as a brief
(1) Be completed within 60 hours of summary of the patient’s condition on
admission; discharge.
(2) Include a medical history;
(3) Contain a record of mental status; [72 FR 60788, Oct. 26, 2007]
(4) Note the onset of illness and the
circumstances leading to admission; § 482.62 Condition of participation:
Special staff requirements for psy-
(5) Describe attitudes and behavior; chiatric hospitals.
(6) Estimate intellectual functioning,
memory functioning, and orientation; The hospital must have adequate
and numbers of qualified professional and
(7) Include an inventory of the pa- supportive staff to evaluate patients,
tient’s assets in descriptive, not inter- formulate written, individualized com-
pretative, fashion. prehensive treatment plans, provide ac-
(c) Standard: Treatment plan. (1) Each tive treatment measures, and engage in
patient must have an individual com- discharge planning.
prehensive treatment plan that must (a) Standard: Personnel. The hospital
be based on an inventory of the pa- must employ or undertake to provide
tient’s strengths and disabilities. The adequate numbers of qualified profes-
written plan must include— sional, technical, and consultative per-
(i) A substantiated diagnosis; sonnel to:
(ii) Short-term and long-range goals; (1) Evaluate patients;

(iii) The specific treatment modali- (2) Formulate written individualized,
ties utilized; comprehensive treatment plans;
38
(3) Provide active treatment meas- and experience in the care of the men-
ures; and tally ill. The director must dem-
(4) Engage in discharge planning. onstrate competence to participate in
(b) Standard: Director of inpatient psy- interdisciplinary formulation of indi-
chiatric services; medical staff. Inpatient vidual treatment plans; to give skilled
psychiatric services must be under the nursing care and therapy; and to di-
supervision of a clinical director, serv- rect, monitor, and evaluate the nursing
ice chief, or equivalent who is qualified care furnished.
to provide the leadership required for
(2) The staffing pattern must insure
an intensive treatment program. The
the availability of a registered profes-
number and qualifications of doctors of
medicine and osteopathy must be ade- sional nurse 24 hours each day. There
quate to provide essential psychiatric must be adequate numbers of reg-
services. istered nurses, licensed practical
(1) The clinical director, service nurses, and mental health workers to
chief, or equivalent must meet the provide the nursing care necessary
training and experience requirements under each patient’s active treatment
for examination by the American program.
Board of Psychiatry and Neurology or (e) Standard: Psychological services.
the American Osteopathic Board of The hospital must provide or have
Neurology and Psychiatry. available psychological services to
(2) The director must monitor and meet the needs of the patients.
evaluate the quality and appropriate- (f) Standard: Social services. There
ness of services and treatment provided must be a director of social services
by the medical staff. who monitors and evaluates the qual-
(c) Standard: Availability of medical
ity and appropriateness of social serv-
personnel. Doctors of medicine or oste-
ices furnished. The services must be
opathy and other appropriate profes-
sional personnel must be available to furnished in accordance with accepted
provide necessary medical and surgical standards of practice and established
diagnostic and treatment services. If policies and procedures.
medical and surgical diagnostic and (1) The director of the social work de-
treatment services are not available partment or service must have a mas-
within the institution, the institution ter’s degree from an accredited school
must have an agreement with an out- of social work or must be qualified by
side source of these services to ensure education and experience in the social
that they are immediately available or services needs of the mentally ill. If
a satisfactory agreement must be es- the director does not hold a masters
tablished for transferring patients to a degree in social work, at least one staff
general hospital that participates in member must have this qualification.
the Medicare program. (2) Social service staff responsibil-
(d) Standard: Nursing services. The ities must include, but are not limited
hospital must have a qualified director
to, participating in discharge planning,
of psychiatric nursing services. In addi-
arranging for follow-up care, and devel-
tion to the director of nursing, there
must be adequate numbers of reg- oping mechanisms for exchange of ap-
istered nurses, licensed practical propriate, information with sources
nurses, and mental health workers to outside the hospital.
provide nursing care necessary under (g) Standard: Therapeutic activities.
each patient’s active treatment pro- The hospital must provide a thera-
gram and to maintain progress notes peutic activities program.
on each patient. (1) The program must be appropriate
(1) The director of psychiatric nurs- to the needs and interests of patients
ing services must be a registered nurse and be directed toward restoring and
who has a master’s degree in psy- maintaining optimal levels of physical
chiatric or mental health nursing, or and psychosocial functioning.
its equivalent from a school of nursing

accredited by the National League for
Nursing, or be qualified by education
39
§ 482.68 42 CFR Ch. IV (10–1–17 Edition)
(2) The number of qualified thera- hospital with an existing Medicare-ap-

pists, support personnel, and consult- proved heart transplant center and an
ants must be adequate to provide com- existing Medicare-approved lung center
prehensive therapeutic activities con- that performs combined heart-lung
sistent with each patient’s active transplants.
treatment program. Intestine transplant center means a
[72 FR 60788, Oct. 26, 2007] Medicare-approved liver transplant
center that performs intestine trans-
§ 482.68 Special requirement for transplants, combined liver-intestine trans-
plant centers. plants, or multivisceral transplants.
A transplant center located within a Network organization means the ad-
hospital that has a Medicare provider ministrative governing body to the
agreement must meet the conditions of network and liaison to the Federal gov-
participation specified in §§ 482.72 ernment.
through 482.104 in order to be granted Pancreas transplant center means a
approval from CMS to provide trans- Medicare-approved kidney transplant
plant services. center that performs pancreas trans-
(a) Unless specified otherwise, the plants alone or subsequent to a kidney
conditions of participation at §§ 482.72 transplant as well as kidney-pancreas
through 482.104 apply to heart, heart- transplants.
lung, intestine, kidney, liver, lung, and Transplant center means an organ-spe-
pancreas centers. cific transplant program (as defined in
(b) In addition to meeting the condi- this rule) within a transplant hospital
tions of participation specified in (for example, a hospital’s lung trans-
§§ 482.72 through 482.104, a transplant plant program may also be referred to
center must also meet the conditions as the hospital’s lung transplant cen-
of participation in §§ 482.1 through ter).
482.57, except for § 482.15. Transplant hospital means a hospital
[81 FR 64030, Sept. 16, 2016] that furnishes organ transplants and
other medical and surgical specialty
§ 482.70 Definitions. services required for the care of trans-
As used in this subpart, the following plant patients.
definitions apply: Transplant program means a compo-
Adverse event means an untoward, un- nent within a transplant hospital (as
desirable, and usually unanticipated defined in this rule) that provides
event that causes death or serious in- transplantation of a particular type of
jury, or the risk thereof. As applied to organ.
transplant centers, examples of adverse
events include (but are not limited to) GENERAL REQUIREMENTS FOR
serious medical complications or death TRANSPLANT CENTERS
caused by living donation; uninten-
tional transplantation of organs of § 482.72 Condition of participation:
OPTN membership.
mismatched blood types; transplan-
tation of organs to unintended bene- A transplant center must be located
ficiaries; and unintended transmission in a transplant hospital that is a mem-
of infectious disease to a beneficiary. ber of and abides by the rules and re-
End-Stage Renal Disease (ESRD) quirements of the Organ Procurement
means that stage of renal impairment and Transplantation Network (OPTN)
that appears irreversible and perma- established and operated in accordance
nent, and requires a regular course of with section 372 of the Public Health
dialysis or kidney transplantation to Service (PHS) Act (42 U.S.C. 274). The
maintain life. term ‘‘rules and requirements of the
ESRD Network means all Medicare- OPTN’’ means those rules and require-
approved ESRD facilities in a des- ments approved by the Secretary pur-
ignated geographic area specified by suant to § 121.4 of this title. No hospital
CMS. that provides transplantation services

Heart-Lung transplant center means a shall be deemed to be out of compli-
transplant center that is located in a ance with section 1138(a)(1)(B) of the
40
Act or this section unless the Sec- 482.104 with respect to its pediatric pa-
retary has given the OPTN formal no- tients.
tice that he or she approves the deci- (b) A center that performs 50 percent
sion to exclude the transplant hospital or more of its transplants in a 12-
from the OPTN and also has notified month period on adult patients must
the transplant hospital in writing. be approved to perform adult trans-
plants in order to be approved to per-
§ 482.74 Condition of participation: No- form pediatric transplants.
tification to CMS.
(1) Loss of Medicare approval to per-
(a) A transplant center must notify form adult transplants, whether vol-
CMS immediately of any significant untary or involuntary, will result in
changes related to the center’s trans- loss of the center’s approval to perform
plant program or changes that could pediatric transplants.
affect its compliance with the condi- (2) Loss of Medicare approval to per-
tions of participation. Instances in form pediatric transplants, whether
which CMS should receive information voluntary or involuntary, may trigger
for follow up, as appropriate, include, a review of the center’s Medicare ap-
but are not limited to: proval to perform adult transplants.
(1) Change in key staff members of (c) A center that performs 50 percent
the transplant team, such as a change or more of its transplants in a 12-
in the individual the transplant center month period on pediatric patients
designated to the OPTN as the center’s must be approved to perform pediatric
‘‘primary transplant surgeon’’ or ‘‘pri- transplants in order to be approved to
mary transplant physician;’ perform adult transplants.
(2) Termination of an agreement be- (1) Loss of Medicare approval to per-
tween the hospital in which the trans- form pediatric transplants, whether
plant center is located and an OPO for voluntary or involuntary, will result in
the recovery and receipt of organs as loss of the center’s approval to perform
required by section 482.100; and adult transplants.
(3) Inactivation of the transplant (2) Loss of Medicare approval to per-
center. form adult transplants, whether vol-
(b) Upon receiving notification of sig- untary or involuntary, may trigger a
nificant changes, CMS will follow up review of the center’s Medicare ap-
with the transplant center as appro- proval to perform pediatric trans-
priate, including (but not limited to): plants.
(1) Requesting additional informa- (3) A center that performs 50 percent
tion; or more of its transplants on pediatric
(2) Analyzing the information; or patients in a 12-month period is not re-
(3) Conducting an on-site review. quired to meet the clinical experience
[72 FR 15273, Mar. 30, 2007, as amended at 79 requirements prior to its request for
FR 27155, May 12, 2014] approval as a pediatric transplant cen-
ter.
§ 482.76 Condition of participation: Pe- (d) Instead of meeting all conditions
diatric Transplants. of participation at §§ 482.72 through
A transplant center that seeks Medi- 482.74 and §§ 482.80 through 482.104, a
care approval to provide transplan- heart transplant center that wishes to
tation services to pediatric patients provide transplantation services to pe-
must submit to CMS a request specifi- diatric heart patients may be approved
cally for Medicare approval to perform to perform pediatric heart transplants
pediatric transplants using the proce- by meeting the Omnibus Budget Rec-
dures described at § 488.61 of this chap- onciliation Act of 1987 criteria in sec-
ter. tion 4009(b) (Pub. L. 100–203), as follows:
(a) Except as specified in paragraph (1) The center’s pediatric transplant
(d) of this section, a center requesting program must be operated jointly by
Medicare approval to perform pediatric the hospital and another facility that
transplants must meet all the condi- is Medicare-approved;

tions of participation at §§ 482.72 (2) The unified program shares the
through 482.74 and §§ 482.80 through same transplant surgeons and quality
41
§ 482.78 42 CFR Ch. IV (10–1–17 Edition)
improvement program (including over- tablished by the OPTN, a transplant

sight committee, patient protocol, and center must submit to the OPTN at
patient selection criteria); and least 95 percent of required data on all
(3) The center demonstrates to the transplants (deceased and living donor)
satisfaction of the Secretary that it is it has performed. Required data sub-
able to provide the specialized facili- missions include, but are not limited
ties, services, and personnel that are to, submission of the appropriate
required by pediatric heart transplant OPTN forms for transplant candidate
patients. registration, transplant beneficiary
registration and follow-up, and living
§ 482.78 Condition of participation:
Emergency preparedness for trans- donor registration and follow-up.
plant centers. (b) Standard: Clinical experience. To be
considered for initial approval, an
A transplant center must be included
organ-specific transplant center must
in the emergency preparedness plan-
generally perform 10 transplants over a
ning and the emergency preparedness
12-month period.
program as set forth in § 482.15 for the
hospital in which it is located. How- (c) Standard: Outcome requirements.
ever, a transplant center is not individ- CMS will review outcomes for all
ually responsible for the emergency transplants performed at a center, in-
preparedness requirements set forth in cluding outcomes for living donor
§ 482.15. transplants, if applicable. CMS will re-
(a) Standard: Policies and procedures. view adult and pediatric outcomes sep-
A transplant center must have policies arately when a center requests Medi-
and procedures that address emergency care approval to perform both adult
preparedness. These policies and proce- and pediatric transplants.
dures must be included in the hos- (1) CMS will compare each transplant
pital’s emergency preparedness pro- center’s observed number of patient
gram. deaths and graft failures 1-year post-
(b) Standard: Protocols with hospital transplant to the center’s expected
and OPO. A transplant center must de- number of patient deaths and graft
velop and maintain mutually agreed failures 1-year post-transplant using
upon protocols that address the duties the data contained in the most recent
and responsibilities of the transplant Scientific Registry of Transplant Bene-
center, the hospital in which the trans- ficiaries (SRTR) center-specific report.
plant center is operated, and the OPO (2) CMS will not consider a center’s
designated by the Secretary, unless the patient and graft survival rates to be
hospital has an approved waiver to acceptable if:
work with another OPO, during an (i) A center’s observed patient sur-
emergency. vival rate or observed graft survival
[81 FR 64030, Sept. 16, 2016] rate is lower than its expected patient
survival rate or expected graft survival
TRANSPLANT CENTER DATA SUBMISSION, rate; and
CLINICAL EXPERIENCE, AND OUTCOME (ii) All three of the following thresh-
REQUIREMENTS olds are crossed over:
(A) The one-sided p-value is less than
Data submission, clinical experi- 0.05,
ence, and outcome requirements for (B) The number of observed events
initial approval of transplant cen- (patient deaths or graft failures) minus
ters. the number of expected events is great-
Except as specified in paragraph (d) er than 3, and
of this section, and § 488.61 of this chap- (C) The number of observed events di-
ter, transplant centers must meet all vided by the number of expected events
data submission, clinical experience, is greater than 1.85.
and outcome requirements to be grant- (d) Exceptions. (1) A heart-lung trans-
ed initial approval by CMS. plant center is not required to comply

(a) Standard: Data submission. No with the clinical experience require-
later than 90 days after the due date es- ments in paragraph (b) of this section
42
or the outcome requirements in para- (b) Standard: Clinical experience. To be

graph (c) of this section for heart-lung considered for re-approval, an organ-
transplants performed at the center. specific transplant center must gen-
(2) An intestine transplant center is erally perform an average of 10 trans-
not required to comply with the out- plants per year during the prior 3
come performance requirements in years.
paragraph (c) of this section for intes- (c) Standard: Outcome requirements.
tine, combined liver-intestine or multi- CMS will review outcomes for all
visceral transplants performed at the transplants performed at a center, in-
center. cluding outcomes for living donor
(3) A pancreas transplant center is transplants, if applicable. CMS will re-
not required to comply with the clin- view adult and pediatric outcomes sep-
ical experience requirements in para- arately when a center requests Medi-
graph (b) of this section or the outcome care approval to perform both adult
requirements in paragraph (c) of this and pediatric transplants.
section for pancreas transplants per- (1) CMS will compare each transplant
formed at the center. center’s observed number of patient
(4) A center that is requesting initial deaths and graft failures 1-year post-
Medicare approval to perform pediatric transplant to the center’s expected
number of patient deaths and graft
transplants is not required to comply
failures 1-year post-transplant using
with the clinical experience require-
data contained in the most recent
ments in paragraph (b) of this section
SRTR center-specific report.
prior to its request for approval as a
(2) CMS will not consider a center’s
pediatric transplant center.
patient and graft survival rates to be
(5) A kidney transplant center that is acceptable if:
not Medicare-approved on the effective (i) A center’s observed patient sur-
date of this rule is required to perform vival rate or observed graft survival
at least 3 transplants over a 12-month rate is lower than its expected patient
period prior to its request for initial survival rate and graft survival rate;
approval. and
[72 FR 15273, Mar. 30, 2007, as amended at 79 (ii) All three of the following thresh-
FR 27155, May 12, 2014; 81 FR 79880, Nov. 14, olds are crossed over:
2016] (A) The one-sided p-value is less than
0.05,
§ 482.82 Condition of participation: (B) The number of observed events
Data submission, clinical experi- (patient deaths or graft failures) minus
ence, and outcome requirements for the number of expected events is great-
re-approval of transplant centers.
er than 3, and
Except as specified in paragraph (d) (C) The number of observed events di-
of this section, and § 488.61 of this chap- vided by the number of expected events
ter, transplant centers must meet all is greater than 1.85.
data submission, clinical experience, (d) Exceptions. (1) A heart-lung trans-
and outcome requirements in order to plant center is not required to comply
be re-approved. with the clinical experience require-
(a) Standard: Data submission. No ments in paragraph (b) of this section
later than 90 days after the due date es- or the outcome requirements in para-
tablished by the OPTN, a transplant graph (c) of this section for heart-lung
center must submit to the OPTN at transplants performed at the center.
least 95 percent of the required data (2) An intestine transplant center is
submissions on all transplants (de- not required to comply with the out-
ceased and living donors) performed come requirements in paragraph (c) of
during the prior 3 years. Required data this section for intestine, combined
submissions include, but are not lim- liver-intestine, and multivisceral
ited to, submission of the appropriate transplants performed at the center.
OPTN forms for transplant candidate (3) A pancreas transplant center is
registration, transplant recipient reg- not required to comply with the clin-
istration and follow-up, and living ical experience requirements in para-
donor registration and follow-up. graph (b) of this section or the outcome
43
§ 482.90 42 CFR Ch. IV (10–1–17 Edition)
requirements in paragraph (c) of this (1) Ensure that a prospective living

section for pancreas transplants per- donor receives a medical and psycho-
formed at the center. social evaluation prior to donation,
(4) A center that is approved to per- (2) Document in the living donor’s
form pediatric transplants is not re- medical records the living donor’s suit-
quired to comply with the clinical ex- ability for donation, and
perience requirements in paragraph (b) (3) Document that the living donor
of this section to be re-approved. has given informed consent, as required
under § 482.102.
[72 FR 15273, Mar. 30, 2007, as amended at 79
FR 27155, May 12, 2014; 81 FR 79880, Nov. 14, § 482.92 Condition of participation:
2016] Organ recovery and receipt.
Transplant centers must have writ-
TRANSPLANT CENTER PROCESS ten protocols for validation of donor-
REQUIREMENTS beneficiary blood type and other vital
data for the deceased organ recovery,
§ 482.90 Condition of participation: Pa- organ receipt, and living donor organ
tient and living donor selection.
transplantation processes. The trans-
The transplant center must use writ- planting surgeon at the transplant cen-
ten patient selection criteria in deter- ter is responsible for ensuring the med-
mining a patient’s suitability for ical suitability of donor organs for
placement on the waiting list or a pa- transplantation into the intended bene-
tient’s suitability for transplantation. ficiary.
If a center performs living donor trans- (a) Standard: Organ receipt. After an
plants, the center also must use writ- organ arrives at a transplant center,
ten donor selection criteria in deter- prior to transplantation, the trans-
mining the suitability of candidates for planting surgeon and another licensed
donation. health care professional must verify
(a) Standard: Patient selection. Patient that the donor’s blood type and other
selection criteria must ensure fair and vital data are compatible with trans-
non-discriminatory distribution of or- plantation of the intended beneficiary.
gans. (b) Standard: Living donor transplan-
(1) Prior to placement on the center’s tation. If a center performs living donor
transplants, the transplanting surgeon
waiting list, a prospective transplant
and another licensed health care pro-
candidate must receive a psychosocial
fessional at the center must verify that
evaluation, if possible.
the living donor’s blood type and other
(2) Before a transplant center places vital data are compatible with trans-
a transplant candidate on its waiting plantation of the intended beneficiary
list, the candidate’s medical record immediately before the removal of the
must contain documentation that the donor organ(s) and, if applicable, prior
candidate’s blood type has been deter- to the removal of the beneficiary ’s
mined. organ(s).
(3) When a patient is placed on a cen-
ter’s waiting list or is selected to re- [51 FR 22042, June 17, 1986, as amended at 77
FR 29076, May 16, 2012]
ceive a transplant, the center must
document in the patient’s medical § 482.94 Condition of participation: Pa-
record the patient selection criteria tient and living donor management.
used. Transplant centers must have writ-
(4) A transplant center must provide ten patient management policies for
a copy of its patient selection criteria the transplant and discharge phases of
to a transplant patient, or a dialysis transplantation. If a transplant center
facility, as requested by a patient or a performs living donor transplants, the
dialysis facility. center also must have written donor
(b) Standard: Living donor selection. management policies for the donor
The living donor selection criteria evaluation, donation, and discharge
must be consistent with the general phases of living organ donation.

principles of medical ethics. Trans- (a) Standard: Patient and living donor
plant centers must: care. The transplant center’s patient
44
and donor management policies must after the date the patient was removed
ensure that: from the waiting list.
(1) Each transplant patient is under (3) In the case of patients admitted
the care of a multidisciplinary patient for organ transplants, transplant cen-
care team coordinated by a physician ters must maintain written records of:
throughout the transplant and dis- (i) Multidisciplinary patient care
charge phases of transplantation; and planning during the transplant period;
(2) If a center performs living donor and
transplants, each living donor is under (ii) Multidisciplinary discharge plan-
the care of a multidisciplinary patient ning for post-transplant care.
care team coordinated by a physician (d) Standard: Social services. The
throughout the donor evaluation, dona- transplant center must make social
tion, and discharge phases of donation. services available, furnished by quali-
(b) Standard: Waiting list management. fied social workers, to transplant pa-
Transplant centers must keep their tients, living donors, and their fami-
waiting lists up to date on an ongoing lies. A qualified social worker is an in-
basis, including: dividual who meets licensing require-
(1) Updating of waiting list patients’ ments in the State in which he or she
clinical information; practices; and
(2) Removing patients from the cen- (1) Completed a course of study with
ter’s waiting list if a patient receives a specialization in clinical practice and
transplant or dies, or if there is any holds a master’s degree from a grad-
other reason the patient should no uate school of social work accredited
longer be on a center’s waiting list; and by the Council on Social Work Edu-
(3) Notifying the OPTN no later than cation; or
24 hours after a patient’s removal from (2) Is working as a social worker in a
the center’s waiting list. transplant center as of the effective
(c) Standard: Patient records. Trans- date of this final rule and has served
plant centers must maintain up-to-date for at least 2 years as a social worker,
and accurate patient management 1 year of which was in a transplan-
records for each patient who receives tation program, and has established a
an evaluation for placement on a cen- consultative relationship with a social
ter’s waiting list and who is admitted worker who is qualified under (d)(1) of
for organ transplantation. this paragraph.
(1) For each patient who receives an (e) Standard: Nutritional services.
evaluation for placement on a center’s Transplant centers must make nutri-
waiting list, the center must document tional assessments and diet counseling
in the patient’s record that the patient services, furnished by a qualified dieti-
(and in the case of a kidney patient, tian, available to all transplant pa-
the patient’s usual dialysis facility) tients and living donors. A qualified di-
has been informed of his or her trans- etitian is an individual who meets
plant status, including notification of: practice requirements in the State in
(i) The patient’s placement on the which he or she practices and is a reg-
center’s waiting list; istered dietitian with the Commission
(ii) The center’s decision not to place on Dietetic Registration.
the patient on its waiting list; or
(iii) The center’s inability to make a § 482.96 Condition of participation:
determination regarding the patient’s Quality assessment and perform-
placement on its waiting list because ance improvement (QAPI).
further clinical testing or documenta- Transplant centers must develop, im-
tion is needed. plement, and maintain a written, com-
(2) If a patient on the waiting list is prehensive, data-driven QAPI program
removed from the waiting list for any designed to monitor and evaluate per-
reason other than death or transplan- formance of all transplantation serv-
tation, the transplant center must doc- ices, including services provided under
ument in the patient’s record that the contract or arrangement.
patient (and in the case of a kidney pa- (a) Standard: Components of a QAPI
tient, the patient’s usual dialysis facil- program. The transplant center’s QAPI
ity) was notified no later than 10 days program must use objective measures
45
§ 482.98 42 CFR Ch. IV (10–1–17 Edition)
to evaluate the center’s performance (1) Coordinating with the hospital in

with regard to transplantation activi- which the transplant center is located
ties and outcomes. Outcome measures to ensure adequate training of nursing
may include, but are not limited to, pa- staff and clinical transplant coordina-
tient and donor selection criteria, ac- tors in the care of transplant patients
curacy of the waiting list in accord- and living donors.
ance with the OPTN waiting list re- (2) Ensuring that tissue typing and
quirements, accuracy of donor and ben- organ procurement services are avail-
eficiary matching, patient and donor able.
management, techniques for organ re- (3) Ensuring that transplantation
covery, consent practices, patient edu- surgery is performed by, or under the
cation, patient satisfaction, and pa- direct supervision of, a qualified trans-
tient rights. The transplant center plant surgeon in accordance with
must take actions that result in per- § 482.98(b).
formance improvements and track per- (b) Standard: Transplant surgeon and
formance to ensure that improvements physician. The transplant center must
are sustained. identify to the OPTN a primary trans-
(b) Standard: Adverse events. A transplant surgeon and a transplant physi-
plant center must establish and imple- cian with the appropriate training and
ment written policies to address and experience to provide transplantation
document adverse events that occur services, who are immediately avail-
during any phase of an organ trans- able to provide transplantation serv-
plantation case. ices when an organ is offered for trans-
(1) The policies must address, at a plantation.
minimum, the process for the identi- (1) The transplant surgeon is respon-
fication, reporting, analysis, and pre- sible for providing surgical services re-
vention of adverse events. lated to transplantation.
(2) The transplant center must con- (2) The transplant physician is re-
duct a thorough analysis of and docu- sponsible for providing and coordi-
ment any adverse event and must uti- nating transplantation care.
lize the analysis to effect changes in (c) Standard: Clinical transplant coor-
the transplant center’s policies and dinator. The transplant center must
practices to prevent repeat incidents. have a clinical transplant coordinator
to ensure the continuity of care of pa-
§ 482.98 Condition of participation: tients and living donors during the pre-
Human resources. transplant, transplant, and discharge
The transplant center must ensure phases of transplantation and the
that all individuals who provide serv- donor evaluation, donation, and dis-
ices and/or supervise services at the charge phases of donation. The clinical
center, including individuals fur- transplant coordinator must be a reg-
nishing services under contract or ar- istered nurse or clinician licensed by
rangement, are qualified to provide or the State in which the clinical trans-
supervise such services. plant coordinator practices, who has
(a) Standard: Director of a transplant experience and knowledge of transplan-
center. The transplant center must be tation and living donation issues. The
under the general supervision of a clinical transplant coordinator’s re-
qualified transplant surgeon or a quali- sponsibilities must include, but are not
fied physician-director. The director of limited to, the following:
a transplant center need not serve full- (1) Ensuring the coordination of the
time and may also serve as a center’s clinical aspects of transplant patient
primary transplant surgeon or trans- and living donor care; and
plant physician in accordance with (2) Acting as a liaison between a kid-
§ 482.98(b). The director is responsible ney transplant center and dialysis fa-
for planning, organizing, conducting, cilities, as applicable.
and directing the transplant center and (d) Standard: Independent living donor
must devote sufficient time to carry advocate or living donor advocate team.
out these responsibilities, which in- The transplant center that performs
clude but are not limited to the fol- living donor transplantation must
lowing: identify either an independent living
46
donor advocate or an independent liv- the OPO with respect to organ recovery
ing donor advocate team to ensure pro- and organ allocation.
tection of the rights of living donors
and prospective living donors. § 482.102 Condition of participation:
(1) The living donor advocate or liv- Patient and living donor rights.
ing donor advocate team must not be In addition to meeting the condition
involved in transplantation activities of participation ‘‘Patients rights’’ re-
on a routine basis. quirements at § 482.13, the transplant
(2) The independent living donor ad- center must protect and promote each
vocate or living donor advocate team transplant patient’s and living donor’s
must demonstrate: rights.
(i) Knowledge of living organ dona- (a) Standard: Informed consent for
tion, transplantation, medical ethics, transplant patients. Transplant centers
and informed consent; and must implement written transplant pa-
(ii) Understanding of the potential tient informed consent policies that in-
impact of family and other external form each patient of:
pressures on the prospective living do- (1) The evaluation process;
nor’s decision whether to donate and (2) The surgical procedure;
the ability to discuss these issues with (3) Alternative treatments;
the donor. (4) Potential medical or psychosocial
(3) The independent living donor ad- risks;
vocate or living donor advocate team is (5) National and transplant center-
responsible for: specific outcomes, from the most re-
(i) Representing and advising the cent SRTR center-specific report, in-
donor; cluding (but not limited to) the trans-
(ii) Protecting and promoting the in- plant center’s observed and expected 1-
terests of the donor; and year patient and graft survival, na-
(iii) Respecting the donor’s decision tional 1-year patient and graft sur-
and ensuring that the donor’s decision vival, and notification about all Medi-
is informed and free from coercion. care outcome requirements not being
(e) Standard: Transplant team. The met by the transplant center;
transplant center must identify a mul- (6) Organ donor risk factors that
tidisciplinary transplant team and de- could affect the success of the graft or
scribe the responsibilities of each the health of the patient, including,
member of the team. The team must be but not limited to, the donor’s history,
composed of individuals with the ap- condition or age of the organs used, or
propriate qualifications, training, and the patient’s potential risk of con-
experience in the relevant areas of tracting the human immunodeficiency
medicine, nursing, nutrition, social virus and other infectious diseases if
services, transplant coordination, and the disease cannot be detected in an in-
pharmacology. fected donor;
(f) Standard: Resource commitment. (7) His or her right to refuse trans-
The transplant center must dem- plantation; and
onstrate availability of expertise in in- (8) The fact that if his or her trans-
ternal medicine, surgery, anesthesi- plant is not provided in a Medicare-ap-
ology, immunology, infectious disease proved transplant center it could affect
control, pathology, radiology, blood the transplant beneficiary ’s ability to
banking, and patient education as re- have his or her immunosuppressive
lated to the provision of transplan- drugs paid for under Medicare Part B.
tation services. (b) Standard: Informed consent for liv-
ing donors. Transplant centers must
§ 482.100 Condition of participation: implement written living donor in-
Organ procurement. formed consent policies that inform
The transplant center must ensure the prospective living donor of all as-
that the hospital in which it operates pects of, and potential outcomes from,
has a written agreement for the receipt living donation. Transplant centers
of organs with an OPO designated by must ensure that the prospective living
the Secretary that identifies specific donor is fully informed about the fol-
responsibilities for the hospital and for lowing:
47
§ 482.104 42 CFR Ch. IV (10–1–17 Edition)
(1) The fact that communication be- transfer to the waiting list of another
tween the donor and the transplant Medicare-approved transplant center
center will remain confidential, in ac- without loss of time accrued on the
cordance with the requirements at 45 waiting list; and
CFR parts 160 and 164. (ii) Inform Medicare beneficiaries on
(2) The evaluation process; the center’s waiting list that Medicare
(3) The surgical procedure, including will no longer pay for transplants per-
post-operative treatment; formed at the center after the effective
(4) The availability of alternative date of the center’s termination of ap-
treatments for the transplant bene- proval.
ficiary; (3) As soon as possible prior to a
(5) The potential medical or psycho- transplant center’s voluntary inactiva-
social risks to the donor; tion, the center must inform patients
(6) The national and transplant cen- on the center’s waiting list and, as di-
ter-specific outcomes for beneficiaries, rected by the Secretary, provide assist-
and the national and center-specific ance to waiting list patients who
outcomes for living donors, as data are choose to transfer to the waiting list of
available; another Medicare-approved transplant
(7) The possibility that future health center without loss of time accrued on
problems related to the donation may the waiting list.
not be covered by the donor’s insurance
and that the donor’s ability to obtain § 482.104 Condition of participation:
health, disability, or life insurance Additional requirements for kidney
transplant centers.
may be affected;
(8) The donor’s right to opt out of do- (a) Standard: End stage renal disease
nation at any time during the donation (ESRD) services. Kidney transplant cen-
process; and ters must directly furnish transplan-
(9) The fact that if a transplant is not tation and other medical and surgical
provided in a Medicare-approved trans- specialty services required for the care
plant center it could affect the trans- of ESRD patients. A kidney transplant
plant beneficiary’s ability to have his center must have written policies and
or her immunosuppressive drugs paid procedures for ongoing communica-
for under Medicare Part B. tions with dialysis patients’ local di-
(c) Standard: Notification to patients. alysis facilities.
Transplant centers must notify pa- (b) Standard: Dialysis services. Kidney
tients placed on the center’s waiting transplant centers must furnish inpa-
list of information about the center tient dialysis services directly or under
that could impact the patient’s ability arrangement.
to receive a transplant should an organ (c) Standard: Participation in network
become available, and what procedures activities. Kidney transplant centers
are in place to ensure the availability must cooperate with the ESRD Net-
of a transplant team. work designated for their geographic
(1) A transplant center served by a area, in fulfilling the terms of the Net-
single transplant surgeon or physician work’s current statement of work.
must inform patients placed on the
center’s waiting list of: PART 483—REQUIREMENTS FOR
(i) The potential unavailability of STATES AND LONG TERM CARE
the transplant surgeon or physician; FACILITIES
and
(ii) Whether the center has a mecha- Subpart A [Reserved]
nism to provide an alternate trans-
plant surgeon or transplant physician. Subpart B—Requirements for Long Term
(2) At least 30 days before a center’s Care Facilities
Medicare approval is terminated,
Sec.
whether voluntarily or involuntarily,
the center must:
483.5 Definitions.
(i) Inform patients on the center’s 483.10 Resident rights.
waiting list and provide assistance to 483.12 Freedom from abuse, neglect, and ex-
waiting list patients who choose to ploitation.
48
Centers for Medicare & Medicaid Services, HHS Pt. 483
483.15 Admission, transfer, and discharge 483.151 State review and approval of nurse
rights. aide training and competency evaluation
483.20 Resident assessment. programs.
483.21 Comprehensive person-centered care 483.152 Requirements for approval of a nurse
planning. aide training and competency evaluation
483.24 Quality of life. program.
483.25 Quality of care.
483.154 Nurse aide competency evaluation.
483.30 Physician services.
483.35 Nursing services. 483.156 Registry of nurse aides.
483.40 Behavioral health services. 483.158 FFP for nurse aide training and
483.45 Pharmacy services. competency evaluation.
483.50 Laboratory, radiology, and other di- 483.160 Requirements for training of paid
agnostic services. feeding assistants.
483.55 Dental services.
483.60 Food and nutrition services. Subpart E—Appeals of Discharges, Trans-
483.65 Specialized rehabilitative services. fers, and Preadmission Screening and
483.70 Administration.
Annual Resident Review (PASARR) De-
483.73 Emergency preparedness.
483.75 Quality assurance and performance terminations
improvement.
483.200 Statutory basis.
483.80 Infection control.
483.85 Compliance and ethics program. 483.202 Definitions.
483.90 Physical environment. 483.204 Provision of a hearing and appeal
483.95 Training requirements. system.
483.206 Transfers, discharges and reloca-
Subpart C—Preadmission Screening and tions subject to appeal.
Annual Review of Mentally Ill and
Mentally Retarded Individuals Subpart F—Requirements That Must Be Met
by States and State Agencies, Resi-
483.100 Basis. dent Assessment
483.102 Applicability and definitions.
483.104 State plan requirement. 483.315 Specification of resident assessment
483.106 Basic rule. instrument.
483.108 Relationship of PASARR to other
Medicaid processes. Subpart G—Condition of Participation for
483.110 Out-of-State arrangements.
483.112 Preadmission screening of applicants
the Use of Restraint or Seclusion in Psy-
for admission to NFs. chiatric Residential Treatment Facilities
483.114 Annual review of NF residents. Providing Inpatient Psychiatric Services
483.116 Residents and applicants determined for Individuals Under Age 21
to require NF level of services.
483.118 Residents and applicants determined 483.350 Basis and scope.
not to require NF level of services. 483.352 Definitions.
483.120 Specialized services. 483.354 General requirements for psychiatric
483.122 FFP for NF services. residential treatment facilities.
483.124 FFP for specialized services. 483.356 Protection of residents.
483.126 Appropriate placement. 483.358 Orders for the use of restraint or se-
483.128 PASARR evaluation criteria. clusion.
483.130 PASARR determination criteria.
483.360 Consultation with treatment team
483.132 Evaluating the need for NF services
physician.
and NF level of care (PASARR/NF).
483.134 Evaluating whether an individual 483.362 Monitoring of the resident in and
with mental illness requires specialized immediately after restraint.
services (PASARR/MI). 483.364 Monitoring of the resident in and
483.136 Evaluating whether an individual immediately after seclusion.
with intellectual disability requires spe- 483.366 Notification of parent(s) or legal
cialized services (PASARR/IID). guardian(s).
483.138 Maintenance of services and avail- 483.368 Application of time out.
ability of FFP. 483.370 Postintervention debriefings.
483.372 Medical treatment for injuries re-
Subpart D—Requirements That Must Be Met sulting from an emergency safety inter-
by States and State Agencies: Nurse vention.
Aide Training and Competency Eval- 483.374 Facility reporting.
uation; and Paid Feeding Assistants 483.376 Education and training.

483.150 Statutory basis; Deemed meeting or
waiver of requirements.
49
§ 483.1 42 CFR Ch. IV (10–1–17 Edition)
Subpart H [Reserved] (i) Skilled nursing facilities or nurs-

ing facility have in operation a compli-
Subpart I—Conditions of Participation for ance and ethics program that is effec-
Intermediate Care Facilities for Individ- tive in preventing and detecting crimi-
uals with Intellectual Disabilities nal, civil, and administrative viola-
483.400 Basis and purpose.
tions.
483.405 Relationship to other HHS regula- (ii) The Secretary establish and im-
tions. plement a quality assurance and per-
483.410 Condition of participation: Gov- formance improvement program for fa-
erning body and management. cilities, including multi-unit chains of
483.420 Condition of participation: Client facilities.
protections. (5) Section 1150B establishes require-
483.430 Condition of participation: Facility ments for reporting to law enforcement
staffing. crimes occurring in federally funded
483.440 Condition of participation: Active
treatment services.
LTC facilities.
483.450 Condition of participation: Client (b) Scope. The provisions of this part
behavior and facility practices. contain the requirements that an insti-
483.460 Condition of participation: Health tution must meet in order to qualify to
care services. participate as a Skilled Nursing Facil-
483.470 Condition of participation: Physical ity in the Medicare program, and as a
environment. nursing facility in the Medicaid pro-
483.475 Condition of participation: Emer- gram. They serve as the basis for sur-
gency preparedness.
vey activities for the purpose of deter-
483.480 Condition of participation: Dietetic
services. mining whether a facility meets the re-
quirements for participation in Medi-
AUTHORITY: Secs. 1102, 1128I, 1819, 1871 and care and Medicaid.
1919 of the Social Security Act (42 U.S.C.
1302, 1320a-7, 1395i, 1395hh and 1396r). [56 FR 48867, Sept. 26, 1991, as amended at 57
FR 43924, Sept. 23, 1992; 60 FR 50443, Sept. 29,
1995; 81 FR 68848, Oct. 4, 2016]
Subpart A [Reserved]
§ 483.5 Definitions.
Subpart B—Requirements for Long As used in this subpart, the following
Term Care Facilities definitions apply:
Abuse. Abuse is the willful infliction
SOURCE: 54 FR 5359, Feb. 2, 1989, unless oth- of injury, unreasonable confinement,
erwise noted. intimidation, or punishment with re-
sulting physical harm, pain or mental
§ 483.1 Basis and scope. anguish. Abuse also includes the depri-
(a) Statutory basis. (1) Sections vation by an individual, including a
1819(a), (b), (c), (d), and (f) of the Act caretaker, of goods or services that are
provide that— necessary to attain or maintain phys-
(i) Skilled nursing facilities partici- ical, mental, and psychosocial well-
pating in Medicare must meet certain being. Instances of abuse of all resi-
specified requirements; and dents, irrespective of any mental or
(ii) The Secretary may impose addi- physical condition, cause physical
tional requirements (see section harm, pain or mental anguish. It in-
1819(d)(4)(B)) if they are necessary for cludes verbal abuse, sexual abuse,
the health and safety of individuals to physical abuse, and mental abuse in-
whom services are furnished in the fa- cluding abuse facilitated or enabled
cilities. through the use of technology. Willful,
(2) Section 1861(l) of the Act requires as used in this definition of abuse,
the facility to have in effect a transfer means the individual must have acted
agreement with a hospital. deliberately, not that the individual
(3) Sections 1919(a), (b), (c), (d), and must have intended to inflict injury or
(f) of the Act provide that nursing fa- harm.
cilities participating in Medicaid must Adverse event. An adverse event is an
meet certain specific requirements. untoward, undesirable, and usually un-

(4) Sections 1128I(b) and (c) require anticipated event that causes death or
that— serious injury, or the risk thereof.
50
Common area. Common areas are Distinct part—(1) Definition. A distinct

areas in the facility where residents part SNF or NF is physically distin-
may gather together with other resi- guishable from the larger institution
dents, visitors, and staff or engage in or institutional complex that houses it,
individual pursuits, apart from their meets the requirements of this para-
residential rooms. This includes but is graph and of paragraph (2) of this defi-
not limited to living rooms, dining nition, and meets the applicable statu-
rooms, activity rooms, outdoor areas, tory requirements for SNFs or NFs in
and meeting rooms where residents are sections 1819 or 1919 of the Act, respec-
located on a regular basis. tively. A distinct part SNF or NF may
Composite distinct part—(1) Definition. comprise one or more buildings or des-
A composite distinct part is a distinct ignated parts of buildings (that is,
part consisting of two or more non- wings, wards, or floors) that are: In the
contiguous components that are not lo- same physical area immediately adja-
cated within the same campus, as de- cent to the institution’s main build-
fined in § 413.65(a)(2) of this chapter. ings; other areas and structures that
(2) Requirements. In addition to meet- are not strictly contiguous with the
ing the requirements of specified in the main buildings but are located within
definition of ‘‘distinct part’’ of this sec- close proximity to the main buildings;
tion, a composite distinct part must and any other areas that CMS deter-
meet all of the following requirements: mines on an individual basis, to be part
of the institution’s campus. A distinct
(i) A SNF or NF that is a composite
part must include all of the beds within
of more than one location will be treat-
the designated area, and cannot consist
ed as a single distinct part of the insti-
of a random collection of individual
tution of which it is a distinct part. As
rooms or beds that are scattered
such, the composite distinct part will
throughout the physical plant. The
have only one provider agreement and
term ‘‘distinct part’’ also includes a
only one provider number.
composite distinct part that meets the
(ii) If two or more institutions (each additional requirements specified in
with a distinct part SNF or NF) under- the definition of ‘‘composite distinct
go a change of ownership, CMS must part’’ of this section.
approve the existing SNFs or NFs as (2) Requirements. In addition to meet-
meeting the requirements before they ing the participation requirements for
are considered a composite distinct long-term care facilities set forth else-
part of a single institution. In making where in this subpart, a distinct part
such a determination, CMS considers SNF or NF must meet all of the fol-
whether its approval or disapproval of lowing requirements:
a composite distinct part promotes the (i) The SNF or NF must be operated
effective and efficient use of public under common ownership and control
monies without sacrificing the quality (that is, common governance) by the
of care. institution of which it is a distinct
(iii) If there is a change of ownership part, as evidenced by the following:
of a composite distinct part SNF or (A) The SNF or NF is wholly owned
NF, the assignment of the provider by the institution of which it is a dis-
agreement to the new owner will apply tinct part.
to all of the approved locations that (B) The SNF or NF is subject to the
comprise the composite distinct part by-laws and operating decisions of a
SNF or NF. common governing body.
(iv) To ensure quality of care and (C) The institution of which the SNF
quality of life for all residents, the var- or NF is a distinct part has final re-
ious components of a composite dis- sponsibility for the distinct part’s ad-
tinct part must meet all of the require- ministrative decisions and personnel
ments for participation independently policies, and final approval for the dis-
in each location. tinct part’s personnel actions.
(v) Use of composite distinct parts to (D) The SNF or NF functions as an
segregate residents by payment source integral and subordinate part of the in-
or on a basis other than care needs is stitution of which it is a distinct part,
prohibited. with significant common resource
51
§ 483.5 42 CFR Ch. IV (10–1–17 Edition)
usage of buildings, equipment, per- scribed in § 440.150 of this chapter. For

sonnel, and services. Medicare and Medicaid purposes (in-
(ii) The administrator of the SNF or cluding eligibility, coverage, certifi-
NF reports to and is directly account- cation, and payment), the ‘‘facility’’ is
able to the management of the institu- always the entity that participates in
tion of which the SNF or NF is a dis- the program, whether that entity is
tinct part. comprised of all of, or a distinct part
(iii) The SNF or NF must have a des- of, a larger institution. For Medicare,
ignated medical director who is respon- an SNF (see section 1819(a)(1) of the
sible for implementing care policies Act), and for Medicaid, an NF (see sec-
and coordinating medical care, and tion 1919(a)(1) of the Act) may not be
who is directly accountable to the an institution for mental diseases as
management of the institution of defined in § 435.1010 of this chapter.
which it is a distinct part. Fully sprinklered. A fully sprinklered
(iv) The SNF or NF is financially in- long term care facility is one that has
tegrated with the institution of which all areas sprinklered in accordance
it is a distinct part, as evidenced by with National Fire Protection Associa-
the sharing of income and expenses tion 13 ‘‘Standard for the Installation
with that institution, and the report- of Sprinkler Systems’’ without the use
ing of its costs on that institution’s of waivers or the Fire Safety Evalua-
cost report. tion System.
(v) A single institution can have a Licensed health professional. A li-
maximum of only one distinct part censed health professional is a physi-
SNF and one distinct part NF. cian; physician assistant; nurse practi-
(vi) (A) An institution cannot des- tioner; physical, speech, or occupa-
ignate a distinct part SNF or NF, but tional therapist; physical or occupa-
instead must submit a written request tional therapy assistant; registered
with documentation that demonstrates professional nurse; licensed practical
it meets the criteria set forth above to nurse; or licensed or certified social
CMS to determine if it may be consid- worker; or registered respiratory ther-
ered a distinct part. apist or certified respiratory therapy
(B) The effective date of approval of technician.
a distinct part is the date that CMS de- Major modification means the modi-
termines all requirements (including fication of more than 50 percent, or
enrollment with the fiscal inter- more than 4,500 square feet, of the
mediary (FI)) are met for approval, and smoke compartment.
cannot be made retroactive. Misappropriation of resident property
(C) The institution must request ap- means the deliberate misplacement,
proval from CMS for all proposed exploitation, or wrongful, temporary,
changes in the number of beds in the or permanent use of a resident’s be-
approved distinct part. longings or money without the resi-
Exploitation. Exploitation means tak- dent’s consent.
ing advantage of a resident for personal Mistreatment means inappropriate
gain through the use of manipulation, treatment or exploitation of a resident.
intimidation, threats, or coercion. Neglect is the failure of the facility,
Facility. For purposes of this subpart, its employees or service providers to
facility means a skilled nursing facility provide goods and services to a resident
(SNF) that meets the requirements of that are necessary to avoid physical
sections 1819(a), (b), (c), and (d) of the harm, pain, mental anguish, or emo-
Act, or a nursing facility (NF) that tional distress.
meets the requirements of sections Nurse aide. A nurse aide is any indi-
1919(a), (b), (c), and (d) of the Act. ‘‘Fa- vidual providing nursing or nursing-re-
cility’’ may include a distinct part of lated services to residents in a facility.
an institution (as defined in paragraph This term may also include an indi-
(b) of this section and specified in vidual who provides these services
§ 440.40 and § 440.155 of this chapter), but through an agency or under a contract
does not include an institution for indi- with the facility, but is not a licensed
viduals with intellectual disabilities or health professional, a registered dieti-
persons with related conditions de- tian, or someone who volunteers to
52
provide such services without pay. termination, and communication with

Nurse aides do not include those indi- and access to persons and services in-
viduals who furnish services to resi- side and outside the facility, including
dents only as paid feeding assistants as those specified in this section.
defined in § 488.301 of this chapter. (1) A facility must treat each resi-
Person-centered care. For purposes of dent with respect and dignity and care
this subpart, person-centered care for each resident in a manner and in an
means to focus on the resident as the environment that promotes mainte-
locus of control and support the resi- nance or enhancement of his or her
dent in making their own choices and quality of life, recognizing each resi-
having control over their daily lives. dent’s individuality. The facility must
Resident representative. For purposes protect and promote the rights of the
of this subpart, the term resident rep- resident.
resentative means any of the following: (2) The facility must provide equal
(1) An individual chosen by the resi- access to quality care regardless of di-
dent to act on behalf of the resident in agnosis, severity of condition, or pay-
order to support the resident in deci- ment source. A facility must establish
sion-making; access medical, social or and maintain identical policies and
other personal information of the resi- practices regarding transfer, discharge,
dent; manage financial matters; or re- and the provision of services under the
ceive notifications; State plan for all residents regardless
(2) A person authorized by State or of payment source.
Federal law (including but not limited (b) Exercise of rights. The resident has
to agents under power of attorney, rep- the right to exercise his or her rights
resentative payees, and other fidu- as a resident of the facility and as a
ciaries) to act on behalf of the resident citizen or resident of the United
in order to support the resident in deci- States.
sion-making; access medical, social or (1) The facility must ensure that the
other personal information of the resi- resident can exercise his or her rights
dent; manage financial matters; or re- without interference, coercion, dis-
ceive notifications; crimination, or reprisal from the facil-
(3) Legal representative, as used in ity
section 712 of the Older Americans Act; (2) The resident has the right to be
or. free of interference, coercion, discrimi-
(4) The court-appointed guardian or nation, and reprisal from the facility in
conservator of a resident. exercising his or her rights and to be
(5) Nothing in this rule is intended to supported by the facility in the exer-
expand the scope of authority of any cise of his or her rights as required
resident representative beyond that au- under this subpart.
thority specifically authorized by the (3) In the case of a resident who has
resident, State or Federal law, or a not been adjudged incompetent by the
court of competent jurisdiction. state court, the resident has the right
Sexual abuse is non-consensual sexual to designate a representative, in ac-
contact of any type with a resident. cordance with State law and any legal
Transfer and discharge includes move- surrogate so designated may exercise
ment of a resident to a bed outside of the resident’s rights to the extent pro-
the certified facility whether that bed vided by state law. The same-sex
is in the same physical plant or not. spouse of a resident must be afforded
Transfer and discharge does not refer treatment equal to that afforded to an
to movement of a resident to a bed opposite-sex spouse if the marriage was
within the same certified facility. valid in the jurisdiction in which it was
[68 FR 46071, Aug. 4, 2003, as amended at 71 celebrated.
FR 39229, July 12, 2006; 71 FR 55340, Sept. 22, (i) The resident representative has
2006; 79 FR 27155, May 12, 2014; 81 FR 68848, the right to exercise the resident’s
Oct. 4, 2016; 82 FR 32259, July 13, 2017] rights to the extent those rights are
delegated to the resident representa-
§ 483.10 Resident rights. tive.

(a) Residents rights. The resident has a (ii) The resident retains the right to
right to a dignified existence, self-de- exercise those rights not delegated to a
53
§ 483.10 42 CFR Ch. IV (10–1–17 Edition)
resident representative, including the or her person-centered plan of care, in-

right to revoke a delegation of rights, cluding but not limited to:
except as limited by State law. (i) The right to participate in the
(4) The facility must treat the deci- planning process, including the right to
sions of a resident representative as identify individuals or roles to be in-
the decisions of the resident to the excluded in the planning process, the
tent required by the court or delegated right to request meetings and the right
by the resident, in accordance with ap- to request revisions to the person-cen-
plicable law. tered plan of care.
(5) The facility shall not extend the (ii) The right to participate in estab-
resident representative the right to lishing the expected goals and out-
make decisions on behalf of the resi- comes of care, the type, amount, fre-
dent beyond the extent required by the quency, and duration of care, and any
court or delegated by the resident, in other factors related to the effective-
accordance with applicable law. ness of the plan of care.
(6) If the facility has reason to be- (iii) The right to be informed, in ad-
lieve that a resident representative is
vance, of changes to the plan of care.
making decisions or taking actions
that are not in the best interests of a (iv) The right to receive the services
resident, the facility shall report such and/or items included in the plan of
concerns in the manner required under care.
State law. (v) The right to see the care plan, in-
(7) In the case of a resident adjudged cluding the right to sign after signifi-
incompetent under the laws of a State cant changes to the plan of care.
by a court of competent jurisdiction, (3) The facility shall inform the resi-
the rights of the resident devolve to dent of the right to participate in his
and are exercised by the resident rep- or her treatment and shall support the
resentative appointed under State law resident in this right. The planning
to act on the resident’s behalf. The process must—
court-appointed resident representa- (i) Facilitate the inclusion of the
tive exercises the resident’s rights to resident and/or resident representative.
the extent judged necessary by a court (ii) Include an assessment of the resi-
of competent jurisdiction, in accord- dent’s strengths and needs.
ance with State law (iii) Incorporate the resident’s per-
(i) In the case of a resident represent- sonal and cultural preferences in devel-
ative whose decision-making authority oping goals of care.
is limited by State law or court ap- (4) The right to be informed, in ad-
pointment, the resident retains the
vance, of the care to be furnished and
right to make those decision outside
the type of care giver or professional
the representative’s authority.
that will furnish care.
(ii) The resident’s wishes and pref-
erences must be considered in the exer- (5) The right to be informed in ad-
cise of rights by the representative. vance, by the physician or other practi-
(iii) To the extent practicable, the tioner or professional, of the risks and
resident must be provided with oppor- benefits of proposed care, of treatment
tunities to participate in the care plan- and treatment alternatives or treat-
ning process. ment options and to choose the alter-
(c) Planning and implementing care. native or option he or she prefers.
The resident has the right to be in- (6) The right to request, refuse, and/
formed of, and participate in, his or her or discontinue treatment, to partici-
treatment, including: pate in or refuse to participate in ex-
(1) The right to be fully informed in perimental research, and to formulate
language that he or she can understand an advance directive.
of his or her total health status, in- (7) The right to self-administer medi-
cluding but not limited to, his or her cations if the interdisciplinary team,
medical condition. as defined by § 483.21(b)(2)(ii), has deter-

(2) The right to participate in the de- mined that this practice is clinically
velopment and implementation of his appropriate.
54
(8) Nothing in this paragraph should accommodation of resident needs and

be construed as the right of the resi- preferences except when to do so would
dent to receive the provision of med- endanger the health or safety of the
ical treatment or medical services resident or other residents.
deemed medically unnecessary or inap- (4) The right to share a room with his
propriate. or her spouse when married residents
(d) Choice of attending physician. The live in the same facility and both
resident has the right to choose his or spouses consent to the arrangement.
her attending physician. (5) The right to share a room with his
(1) The physician must be licensed to or her roommate of choice when prac-
practice, and ticable, when both residents live in the
(2) If the physician chosen by the same facility and both residents con-
resident refuses to or does not meet resent to the arrangement.
quirements specified in this part, the (6) The right to receive written no-
facility may seek alternate physician tice, including the reason for the
participation as specified in paragraphs change, before the resident’s room or
(d)(4) and (5) of this section to assure roommate in the facility is changed.
provision of appropriate and adequate (7) The right to refuse to transfer to
care and treatment. another room in the facility, if the pur-
(3) The facility must ensure that pose of the transfer is:
each resident remains informed of the (i) To relocate a resident of a SNF
name, specialty, and way of contacting from the distinct part of the institu-
the physician and other primary care tion that is a SNF to a part of the in-
professionals responsible for his or her stitution that is not a SNF, or
care. (ii) to relocate a resident of a NF
(4) The facility must inform the resi- from the distinct part of the institu-
dent if the facility determines that the tion that is a NF to a distinct part of
physician chosen by the resident is un- the institution that is a SNF.
able or unwilling to meet requirements (iii) solely for the convenience of
specified in this part and the facility staff.
seeks alternate physician participation (8) A resident’s exercise of the right
to assure provision of appropriate and to refuse transfer does not affect the
adequate care and treatment. The fa- resident’s eligibility or entitlement to
cility must discuss the alternative phy- Medicare or Medicaid benefits.
sician participation with the resident (f) Self-determination. The resident
and honor the resident’s preferences, if has the right to and the facility must
any, among options. promote and facilitate resident self-de-
(5) If the resident subsequently se- termination through support of resi-
lects another attending physician who dent choice, including but not limited
meets the requirements specified in to the rights specified in paragraphs
this part, the facility must honor that (f)(1) through (11) of this section.
choice. (1) The resident has a right to choose
(e) Respect and dignity. The resident activities, schedules (including sleep-
has a right to be treated with respect ing and waking times), health care and
and dignity, including: providers of health care services con-
(1) The right to be free from any sistent with his or her interests, assess-
physical or chemical restraints im- ments, plan of care and other applica-
posed for purposes of discipline or con- ble provisions of this part.
venience, and not required to treat the (2) The resident has the right to
resident’s medical symptoms, con- make choices about aspects of his or
sistent with § 483.12(a)(2). her life in the facility that are signifi-
(2) The right to retain and use per- cant to the resident.
sonal possessions, including fur- (3) The resident has a right to inter-
nishings, and clothing, as space per- act with members of the community
mits, unless to do so would infringe and participate in community activi-
upon the rights or health and safety of ties both inside and outside the facil-
other residents. ity.

(3) The right to reside and receive (4) The resident has a right to receive
services in the facility with reasonable visitors of his or her choosing at the
55
§ 483.10 42 CFR Ch. IV (10–1–17 Edition)
time of his or her choosing, subject to need to place on such rights and the
the resident’s right to deny visitation reasons for the clinical or safety re-
when applicable, and in a manner that striction or limitation.
does not impose on the rights of an- (vi) A facility must meet the fol-
other resident. lowing requirements:
(i) The facility must provide imme- (A) Inform each resident (or resident
diate access to any resident by— representative, where appropriate) of
(A) Any representative of the Sec- his or her visitation rights and related
retary, facility policy and procedures, includ-
(B) Any representative of the State, ing any clinical or safety restriction or
(C) Any representative of the Office limitation on such rights, consistent
of the State long term care ombuds- with the requirements of this subpart,
man, (established under section 712 of the reasons for the restriction or limi-
the Older Americans Act of 1965, as tation, and to whom the restrictions
amended 2016 (42 U.S.C. 3001 et seq.), apply, when he or she is informed of his
(D) The resident’s individual physi- or her other rights under this section.
cian, (B) Inform each resident of the right,
(E) Any representative of the protec- subject to his or her consent, to receive
tion and advocacy systems, as des- the visitors whom he or she designates,
ignated by the state, and as established including, but not limited to, a spouse
under the Developmental Disabilities (including a same-sex spouse), a domes-
Assistance and Bill of Rights Act of tic partner (including a same-sex do-
2000 (42 U.S.C. 15001 et seq.), mestic partner), another family mem-
(F) Any representative of the agency ber, or a friend, and his or her right to
responsible for the protection and ad- withdraw or deny such consent at any
vocacy system for individuals with a time.
mental disorder (established under the
(C) Not restrict, limit, or otherwise
Protection and Advocacy for Mentally
deny visitation privileges on the basis
Ill Individuals Act of 2000 (42 U.S.C.
of race, color, national origin, religion,
10801 et seq.), and
sex, gender identity, sexual orienta-
(G) The resident representative.
tion, or disability.
(ii) The facility must provide imme-
(D) Ensure that all visitors enjoy full
diate access to a resident by immediate
and equal visitation privileges con-
family and other relatives of the resi-
sistent with resident preferences.
dent, subject to the resident’s right to
deny or withdraw consent at any time; (5) The resident has a right to orga-
(iii) The facility must provide imme- nize and participate in resident groups
diate access to a resident by others in the facility.
who are visiting with the consent of (i) The facility must provide a resi-
the resident, subject to reasonable clin- dent or family group, if one exists,
ical and safety restrictions and the with private space; and take reasonable
resident’s right to deny or withdraw steps, with the approval of the group,
consent at any time; to make residents and family members
(iv) The facility must provide reason- aware of upcoming meetings in a time-
able access to a resident by any entity ly manner.
or individual that provides health, so- (ii) Staff, visitors, or other guests
cial, legal, or other services to the resi- may attend resident group or family
dent, subject to the resident’s right to group meetings only at the respective
deny or withdraw consent at any time; group’s invitation.
and (iii) The facility must provide a des-
(v) The facility must have written ignated staff person who is approved by
policies and procedures regarding the the resident or family group and the fa-
visitation rights of residents, including cility and who is responsible for pro-
those setting forth any clinically nec- viding assistance and responding to
essary or reasonable restriction or lim- written requests that result from group
itation or safety restriction or limita- meetings.
tion, when such limitations may apply (iv) The facility must consider the
consistent with the requirements of views of a resident or family group and
this subpart, that the facility may act promptly upon the grievances and
56
recommendations of such groups con- (f)(10)(ii)(B) of this section, the facility

cerning issues of resident care and life must deposit any residents’ personal
in the facility. funds in excess of $100 in an interest
(A) The facility must be able to dem- bearing account (or accounts) that is
onstrate their response and rationale separate from any of the facility’s op-
for such response. erating accounts, and that credits all
(B) This should not be construed to interest earned on resident’s funds to
mean that the facility must implement that account. (In pooled accounts,
as recommended every request of the there must be a separate accounting
resident or family group. for each resident’s share.) The facility
(6) The resident has a right to par- must maintain a resident’s personal
ticipate in family groups. funds that do not exceed $100 in a non-
(7) The resident has a right to have interest bearing account, interest-bear-
family member(s) or other resident ing account, or petty cash fund.
representative(s) meet in the facility (B) Residents whose care is funded by
with the families or resident represent- Medicaid: The facility must deposit the
ative(s) of other residents in the facil- residents’ personal funds in excess of
ity. $50 in an interest bearing account (or
(8) The resident has a right to par- accounts) that is separate from any of
ticipate in other activities, including the facility’s operating accounts, and
social, religious, and community ac- that credits all interest earned on resi-
tivities that do not interfere with the dent’s funds to that account. (In pooled
rights of other residents in the facility. accounts, there must be a separate ac-
(9) The resident has a right to choose counting for each resident’s share.) The
to or refuse to perform services for the facility must maintain personal funds
facility and the facility must not re- that do not exceed $50 in a non-interest
quire a resident to perform services for bearing account, interest-bearing ac-
the facility. The resident may perform count, or petty cash fund.
services for the facility, if he or she
(iii) Accounting and records. (A) The
chooses, when—
facility must establish and maintain a
(i) The facility has documented the
system that assures a full and com-
resident’s need or desire for work in
plete and separate accounting, accord-
the plan of care;
ing to generally accepted accounting
(ii) The plan specifies the nature of
principles, of each resident’s personal
the services performed and whether the
funds entrusted to the facility on the
services are voluntary or paid;
resident’s behalf.
(iii) Compensation for paid services is
at or above prevailing rates; and (B) The system must preclude any
(iv) The resident agrees to the work commingling of resident funds with fa-
arrangement described in the plan of cility funds or with the funds of any
care. person other than another resident.
(10) The resident has a right to man- (C) The individual financial record
age his or her financial affairs. This in- must be available to the resident
cludes the right to know, in advance, through quarterly statements and upon
what charges a facility may impose request.
against a resident’s personal funds. (iv) Notice of certain balances. The fa-
(i) The facility must not require resi- cility must notify each resident that
dents to deposit their personal funds receives Medicaid benefits—
with the facility. If a resident chooses (A) When the amount in the resi-
to deposit personal funds with the fa- dent’s account reaches $200 less than
cility, upon written authorization of a the SSI resource limit for one person,
resident, the facility must act as a fi- specified in section 1611(a)(3)(B) of the
duciary of the resident’s funds and Act; and
hold, safeguard, manage, and account (B) That, if the amount in the ac-
for the personal funds of the resident count, in addition to the value of the
deposited with the facility, as specified resident’s other nonexempt resources,
in this section. reaches the SSI resource limit for one

(ii) Deposit of funds. (A) In general: person, the resident may lose eligi-
Except as set out in paragraph bility for Medicaid or SSI.
57
§ 483.10 42 CFR Ch. IV (10–1–17 Edition)
(v) Conveyance upon discharge, evic- denture adhesive, denture cleaner, den-
tion, or death. Upon the discharge, tal floss, moisturizing lotion, tissues,
eviction, or death of a resident with a cotton balls, cotton swabs, deodorant,
personal fund deposited with the facil- incontinence care and supplies, sani-
ity, the facility must convey within 30 tary napkins and related supplies, tow-
days the resident’s funds, and a final els, washcloths, hospital gowns, over
accounting of those funds, to the resi- the counter drugs, hair and nail hy-
dent, or in the case of death, the indi- giene services, bathing assistance, and
vidual or probate jurisdiction admin- basic personal laundry.
istering the resident’s estate, in ac- (F) Medically-related social services
cordance with State law. as required at § 483.40(d).
(vi) Assurance of financial security. (G) Hospice services elected by the
The facility must purchase a surety resident and paid for under the Medi-
bond, or otherwise provide assurance care Hospice Benefit or paid for by
satisfactory to the Secretary, to assure Medicaid under a state plan.
the security of all personal funds of (ii) Items and services that may be
residents deposited with the facility. charged to residents’ funds. Paragraphs
(11) The facility must not impose a (f)(11)(ii)(A) through (L) of this section
charge against the personal funds of a are general categories and examples of
resident for any item or service for items and services that the facility
which payment is made under Medicaid may charge to residents’ funds if they
or Medicare (except for applicable de- are requested by a resident, if they are
ductible and coinsurance amounts). not required to achieve the goals stat-
The facility may charge the resident ed in the resident’s care plan, if the fa-
for requested services that are more ex- cility informs the resident that there
pensive than or in excess of covered will be a charge, and if payment is not
services in accordance with § 489.32 of made by Medicare or Medicaid:
this chapter. (This does not affect the (A) Telephone, including a cellular
prohibition on facility charges for phone.
items and services for which Medicaid (B) Television/radio, personal com-
has paid. See § 447.15 of this chapter, puter or other electronic device for
which limits participation in the Med- personal use.
icaid program to providers who accept, (C) Personal comfort items, including
as payment in full, Medicaid payment smoking materials, notions and nov-
plus any deductible, coinsurance, or co- elties, and confections.
payment required by the plan to be (D) Cosmetic and grooming items and
paid by the individual.) services in excess of those for which
(i) Services included in Medicare or payment is made under Medicaid or
Medicaid payment. During the course Medicare.
of a covered Medicare or Medicaid stay, (E) Personal clothing.
facilities must not charge a resident (F) Personal reading matter.
for the following categories of items (G) Gifts purchased on behalf of a
and services: resident.
(A) Nursing services as required at (H) Flowers and plants.
§ 483.35. (I) Cost to participate in social
(B) Food and Nutrition services as re- events and entertainment outside the
quired at § 483.60. scope of the activities program, pro-
(C) An activities program as required vided under § 483.24(c).
at § 483.24(c). (J) Non-covered special care services
(D) Room/bed maintenance services. such as privately hired nurses or aides.
(E) Routine personal hygiene items (K) Private room, except when thera-
and services as required to meet the peutically required (for example, isola-
needs of residents, including, but not tion for infection control).
limited to, hair hygiene supplies, (L) Except as provided in
comb, brush, bath soap, disinfecting (e)(11)(ii)(L)(1) and (2) of this section,
soaps or specialized cleansing agents specially prepared or alternative food
when indicated to treat special skin requested instead of the food and meals
problems or to fight infection, razor, generally prepared by the facility, as
shaving cream, toothbrush, toothpaste, required by § 483.60.
58
(1) The facility may not charge for vance notice to the facility. The facil-
special foods and meals, including ity may impose a reasonable, cost-
medically prescribed dietary supple- based fee on the provision of copies,
ments, ordered by the resident’s physi- provided that the fee includes only the
cian, physician assistant, nurse practi- cost of:
tioner, or clinical nurse specialist, as (A) Labor for copying the records re-
these are included in accordance with quested by the individual, whether in
§ 483.60. paper or electronic form;
(2) In accordance with § 483.60(c) (B) Supplies for creating the paper
through (f), when preparing foods and copy or electronic media if the indi-
meals, a facility must take into consid- vidual requests that the electronic
eration residents’ needs and pref-
copy be provided on portable media;
erences and the overall cultural and re-
and
ligious make-up of the facility’s popu-
lation. (C) Postage, when the individual has
(iii) Requests for items and services. (A) requested the copy be mailed.
The facility can only charge a resident (3) With the exception of information
for any non-covered item or service if described in paragraphs (g)(2) and
such item or service is specifically re- (g)(11) of this section, the facility must
quested by the resident. ensure that information is provided to
(B) The facility must not require a each resident in a form and manner the
resident to request any item or service resident can access and understand, in-
as a condition of admission or contin- cluding in an alternative format or in a
ued stay. language that the resident can under-
(C) The facility must inform, orally stand. Summaries that translate infor-
and in writing, the resident requesting mation described in paragraph (g)(2) of
an item or service for which a charge this section may be made available to
will be made that there will be a the patient at their request and ex-
charge for the item or service and what pense in accordance with applicable
the charge will be. law.
(g) Information and communication. (1) (4) The resident has the right to re-
The resident has the right to be in- ceive notices orally (meaning spoken)
formed of his or her rights and of all and in writing (including Braille) in a
rules and regulations governing resi- format and a language he or she under-
dent conduct and responsibilities dur- stands, including;
ing his or her stay in the facility. (i) Required notices as specified in this
(2) The resident has the right to ac- section. The facility must furnish to
cess personal and medical records per- each resident a written description of
taining to him or herself. legal rights which includes—
(i) The facility must provide the resi-
(A) A description of the manner of
dent with access to personal and med-
protecting personal funds, under para-
ical records pertaining to him or her-
graph (f)(10) of this section;
self, upon an oral or written request, in
the form and format requested by the (B) A description of the requirements
individual, if it is readily producible in and procedures for establishing eligi-
such form and format (including in an bility for Medicaid, including the right
electronic form or format when such to request an assessment of resources
records are maintained electronically); under section 1924(c) of the Social Se-
or, if not, in a readable hard copy form curity Act.
or such other form and format as (C) A list of names, addresses (mail-
agreed to by the facility and the indi- ing and email), and telephone numbers
vidual, within 24 hours (excluding of all pertinent State regulatory and
weekends and holidays); and informational agencies, resident advo-
(ii) The facility must allow the resi- cacy groups such as the State Survey
dent to obtain a copy of the records or Agency, the State licensure office, the
any portions thereof (including in an State Long-Term Care Ombudsman
electronic form or format when such program, the protection and advocacy
records are maintained electronically) agency, adult protective services where
upon request and 2 working days ad- state law provides for jurisdiction in
59
§ 483.10 42 CFR Ch. IV (10–1–17 Edition)
long-term care facilities, the local con- adult protective services where state
tact agency for information about re- law provides for jurisdiction in long-
turning to the community and the term care facilities, the Office of the
Medicaid Fraud Control Unit; and State Long-Term Care Ombudsman
(D) A statement that the resident program, the protection and advocacy
may file a complaint with the State network, home and community based
Survey Agency concerning any sus- service programs, and the Medicaid
pected violation of state or federal Fraud Control Unit; and
nursing facility regulations, including (ii) A statement that the resident
but not limited to resident abuse, ne- may file a complaint with the State
glect, exploitation, misappropriation of Survey Agency concerning any sus-
resident property in the facility, non- pected violation of state or federal
compliance with the advance directives nursing facility regulations, including
requirements and requests for informa- but not limited to resident abuse, ne-
tion regarding returning to the com- glect, exploitation, misappropriation of
munity. resident property in the facility, non-
(ii) Information and contact informa- compliance with the advance directives
tion for State and local advocacy orga- requirements (42 CFR part 489 subpart
nizations, including but not limited to I) and requests for information regard-
the State Survey Agency, the State ing returning to the community.
Long-Term Care Ombudsman program (6) The resident has the right to have
(established under section 712 of the reasonable access to the use of a tele-
Older Americans Act of 1965, as amend- phone, including TTY and TDD serv-
ed 2016 (42 U.S.C. 3001 et seq.) and the ices, and a place in the facility where
protection and advocacy system (as calls can be made without being over-
designated by the state, and as estab- heard. This includes the right to retain
lished under the Developmental Dis- and use a cellular phone at the resi-
abilities Assistance and Bill of Rights dent’s own expense.
Act of 2000 (42 U.S.C. 15001 et seq.); (7) The facility must protect and fa-
(iii) Information regarding Medicare cilitate that resident’s right to com-
and Medicaid eligibility and coverage; municate with individuals and entities
(iv) Contact information for the within and external to the facility, in-
Aging and Disability Resource Center cluding reasonable access to:
(established under Section (i) A telephone, including TTY and
202(a)(20)(B)(iii) of the Older Americans TDD services;
Act); or other No Wrong Door Program (ii) The internet, to the extent avail-
(v) Contact information for the Med- able to the facility; and
icaid Fraud Control Unit; and (iii) Stationery, postage, writing im-
(vi) Information and contact infor- plements and the ability to send mail.
mation for filing grievances or com- (8) The resident has the right to send
plaints concerning any suspected viola- and receive mail, and to receive let-
tion of state or federal nursing facility ters, packages and other materials de-
regulations, including but not limited livered to the facility for the resident
to resident abuse, neglect, exploi- through a means other than a postal
tation, misappropriation of resident service, including the right to:
property in the facility, non-compli- (i) Privacy of such communications
ance with the advance directives re- consistent with this section; and
quirements and requests for informa- (ii) Access to stationery, postage, and
tion regarding returning to the com- writing implements at the resident’s
munity. own expense.
(5) The facility must post, in a form (9) The resident has the right to have
and manner accessible and understand- reasonable access to and privacy in
able to residents, and resident rep- their use of electronic communications
resentatives: such as email and video communica-
(i) A list of names, addresses (mailing tions and for Internet research.
and email), and telephone numbers of (i) If the access is available to the fa-
all pertinent State agencies and advo- cility

cacy groups, such as the State Survey (ii) At the resident’s expense, if any
Agency, the State licensure office, additional expense is incurred by the
60
facility to provide such access to the cility may give advance directive infor-
resident. mation to the individual’s resident rep-
(iii) Such use must comply with state resentative in accordance with State
and federal law. law.
(10) The resident has the right to— (v) The facility is not relieved of its
(i) Examine the results of the most obligation to provide this information
recent survey of the facility conducted to the individual once he or she is able
by Federal or State surveyors and any to receive such information. Follow-up
plan of correction in effect with re- procedures must be in place to provide
spect to the facility; and the information to the individual di-
(ii) Receive information from agen- rectly at the appropriate time.
cies acting as client advocates, and be (13) The facility must display in the
afforded the opportunity to contact facility written information, and pro-
these agencies. vide to residents and applicants for ad-
(11) The facility must— mission, oral and written information
(i) Post in a place readily accessible about how to apply for and use Medi-
to residents, and family members and care and Medicaid benefits, and how to
legal representatives of residents, the receive refunds for previous payments
results of the most recent survey of the covered by such benefits.
facility. (14) Notification of changes. (i) A facil-
(ii) Have reports with respect to any ity must immediately inform the resi-
surveys, certifications, and complaint dent; consult with the resident’s physi-
investigations made respecting the fa- cian; and notify, consistent with his or
cility during the 3 preceding years, and her authority, the resident representa-
any plan of correction in effect with re- tive(s), when there is—
spect to the facility, available for any (A) An accident involving the resi-
individual to review upon request; and dent which results in injury and has
(iii) Post notice of the availability of the potential for requiring physician
such reports in areas of the facility intervention;
that are prominent and accessible to
(B) A significant change in the resi-
the public.
dent’s physical, mental, or psycho-
(iv) The facility shall not make
social status (that is, a deterioration in
available identifying information
health, mental, or psychosocial status
about complainants or residents.
in either life-threatening conditions or
(12) The facility must comply with
clinical complications);
the requirements specified in 42 CFR
part 489, subpart I (Advance Direc- (C) A need to alter treatment signifi-
cantly (that is, a need to discontinue
tives).
or change an existing form of treat-
(i) These requirements include provi-
ment due to adverse consequences, or
sions to inform and provide written in-
to commence a new form of treatment);
formation to all adult residents con-
or
cerning the right to accept or refuse
medical or surgical treatment and, at (D) A decision to transfer or dis-
the resident’s option, formulate an ad- charge the resident from the facility as
vance directive. specified in § 483.15(c)(1)(ii).
(ii) This includes a written descrip- (ii) When making notification under
tion of the facility’s policies to imple- paragraph (g)(14)(i) of this section, the
ment advance directives and applicable facility must ensure that all pertinent
State law. information specified in § 483.15(c)(2) is
(iii) Facilities are permitted to con- available and provided upon request to
tract with other entities to furnish this the physician.
information but are still legally re- (iii) The facility must also promptly
sponsible for ensuring that the require- notify the resident and the resident
ments of this section are met. representative, if any, when there is—
(iv) If an adult individual is incapaci- (A) A change in room or roommate
tated at the time of admission and is assignment as specified in § 483.10(e)(6);
unable to receive information or ar- or

ticulate whether or not he or she has (B) A change in resident rights under
executed an advance directive, the fa- Federal or State law or regulations as
61
§ 483.10 42 CFR Ch. IV (10–1–17 Edition)
specified in paragraph (e)(10) of this services, including any charges for

section. services not covered under Medicare/
(iv) The facility must record and pe- Medicaid or by the facility’s per diem
riodically update the address (mailing rate.
and email) and phone number of the (i) Where changes in coverage are
resident representative(s). made to items and services covered by
(15) Admission to a composite distinct Medicare and/or by the Medicaid State
part. A facility that is a composite dis- plan, the facility must provide notice
tinct part (as defined in § 483.5 must to residents of the change as soon as is
disclose in its admission agreement its reasonably possible.
physical configuration, including the (ii) Where changes are made to
various locations that comprise the charges for other items and services
composite distinct part, and must that the facility offers, the facility
specify the policies that apply to room must inform the resident in writing at
changes between its different locations least 60 days prior to implementation
under § 483.15(c)(9). of the change.
(16) The facility must provide a no- (iii) If a resident dies or is hospital-
tice of rights and services to the resi- ized or is transferred and does not re-
dent prior to or upon admission and turn to the facility, the facility must
during the resident’s stay. refund to the resident, resident rep-
(i) The facility must inform the resi- resentative, or estate, as applicable,
dent both orally and in writing in a any deposit or charges already paid,
language that the resident understands less the facility’s per diem rate, for the
of his or her rights and all rules and days the resident actually resided or
regulations governing resident conduct reserved or retained a bed in the facil-
and responsibilities during the stay in ity, regardless of any minimum stay or
the facility. discharge notice requirements.
(ii) The facility must also provide the (iv) The facility must refund to the
resident with the State-developed no- resident or resident representative any
tice of Medicaid rights and obligations, and all refunds due the resident within
if any. 30 days from the resident’s date of dis-
(iii) Receipt of such information, and charge from the facility.
any amendments to it, must be ac- (v) The terms of an admission con-
knowledged in writing; tract by or on behalf of an individual
(17) The facility must— seeking admission to the facility must
(i) Inform each Medicaid-eligible not conflict with the requirements of
resident, in writing, at the time of ad- these regulations.
mission to the nursing facility and (h) Privacy and confidentiality. The
when the resident becomes eligible for resident has a right to personal privacy
Medicaid of— and confidentiality of his or her per-
(A) The items and services that are sonal and medical records.
included in nursing facility services (1) Personal privacy includes accom-
under the State plan and for which the modations, medical treatment, written
resident may not be charged; and telephone communications, per-
(B) Those other items and services sonal care, visits, and meetings of fam-
that the facility offers and for which ily and resident groups, but this does
the resident may be charged, and the not require the facility to provide a
amount of charges for those services; private room for each resident.
and (2) The facility must respect the resi-
(ii) Inform each Medicaid-eligible dents right to personal privacy, includ-
resident when changes are made to the ing the right to privacy in his or her
items and services specified in oral (that is, spoken), written, and
§ 483.10(g)(17)(i)(A) and (B) of this sec- electronic communications, including
tion. the right to send and promptly receive
(18) The facility must inform each unopened mail and other letters, pack-
resident before, or at the time of ad- ages and other materials delivered to
mission, and periodically during the the facility for the resident, including
resident’s stay, of services available in those delivered through a means other
the facility and of charges for those than a postal service.
62
(3) The resident has a right to secure other residents; and other concerns re-
and confidential personal and medical garding their LTC facility stay.
records. (2) The resident has the right to and
(i) The resident has the right to the facility must make prompt efforts
refuse the release of personal and med- by the facility to resolve grievances
ical records except as provided at the resident may have, in accordance
§ 483.70(i)(2) or other applicable federal with this paragraph.
or state laws. (3) The facility must make informa-
(ii) The facility must allow rep- tion on how to file a grievance or com-
resentatives of the Office of the State plaint available to the resident.
Long-Term Care Ombudsman to exam- (4) The facility must establish a
ine a resident’s medical, social, and ad- grievance policy to ensure the prompt
ministrative records in accordance resolution of all grievances regarding
with State law. the residents’ rights contained in this
(i) Safe environment. The resident has paragraph. Upon request, the provider
a right to a safe, clean, comfortable must give a copy of the grievance pol-
and homelike environment, including icy to the resident. The grievance pol-
but not limited to receiving treatment icy must include:
and supports for daily living safely.
(i) Notifying resident individually or
The facility must provide—
through postings in prominent loca-
(1) A safe, clean, comfortable, and
tions throughout the facility of the
homelike environment, allowing the
right to file grievances orally (meaning
resident to use his or her personal be-
spoken) or in writing; the right to file
longings to the extent possible.
(i) This includes ensuring that the grievances anonymously; the contact
resident can receive care and services information of the grievance official
safely and that the physical layout of with whom a grievance can be filed,
the facility maximizes resident inde- that is, his or her name, business ad-
pendence and does not pose a safety dress (mailing and email) and business
risk. phone number; a reasonable expected
(ii) The facility shall exercise reason- time frame for completing the review
able care for the protection of the resi- of the grievance; the right to obtain a
dent’s property from loss or theft. written decision regarding his or her
(2) Housekeeping and maintenance grievance; and the contact information
services necessary to maintain a sani- of independent entities with whom
tary, orderly, and comfortable interior; grievances may be filed, that is, the
(3) Clean bed and bath linens that are pertinent State agency, Quality Im-
in good condition; provement Organization, State Survey
(4) Private closet space in each resi- Agency and State Long-Term Care Om-
dent room, as specified in budsman program or protection and ad-
§ 483.90(e)(2)(iv); vocacy system;
(5) Adequate and comfortable light- (ii) Identifying a Grievance Official
ing levels in all areas; who is responsible for overseeing the
(6) Comfortable and safe temperature grievance process, receiving and track-
levels. Facilities initially certified ing grievances through to their conclu-
after October 1, 1990 must maintain a sion; leading any necessary investiga-
temperature range of 71 to 81 °F; and tions by the facility; maintaining the
(7) For the maintenance of com- confidentiality of all information asso-
fortable sound levels. ciated with grievances, for example,
(j) Grievances. (1) The resident has the the identity of the resident for those
right to voice grievances to the facility grievances submitted anonymously;
or other agency or entity that hears issuing written grievance decisions to
grievances without discrimination or the resident; and coordinating with
reprisal and without fear of discrimina- state and federal agencies as necessary
tion or reprisal. Such grievances in- in light of specific allegations;
clude those with respect to care and (iii) As necessary, taking immediate
treatment which has been furnished as action to prevent further potential vio-
well as that which has not been fur- lations of any resident right while the
nished, the behavior of staff and of alleged violation is being investigated;
63
§ 483.12 42 CFR Ch. IV (10–1–17 Edition)
(iv) Consistent with § 483.12(c)(1), im- § 483.12 Freedom from abuse, neglect,
mediately reporting all alleged viola- and exploitation.
tions involving neglect, abuse, includ- The resident has the right to be free
ing injuries of unknown source, and/or from abuse, neglect, misappropriation
misappropriation of resident property, of resident property, and exploitation
by anyone furnishing services on behalf as defined in this subpart. This in-
of the provider, to the administrator of cludes but is not limited to freedom
the provider; and as required by State from corporal punishment, involuntary
law; seclusion and any physical or chemical
(v) Ensuring that all written griev- restraint not required to treat the resi-
ance decisions include the date the dent’s medical symptoms.
grievance was received, a summary (a) The facility must—
statement of the resident’s grievance, (1) Not use verbal, mental, sexual, or
the steps taken to investigate the physical abuse, corporal punishment,
grievance, a summary of the pertinent or involuntary seclusion;
findings or conclusions regarding the (2) Ensure that the resident is free
resident’s concern(s), a statement as to from physical or chemical restraints
whether the grievance was confirmed imposed for purposes of discipline or
or not confirmed, any corrective action convenience and that are not required
taken or to be taken by the facility as to treat the resident’s medical symp-
a result of the grievance, and the date toms. When the use of restraints is in-
the written decision was issued; dicated, the facility must use the least
(vi) Taking appropriate corrective restrictive alternative for the least
action in accordance with State law if amount of time and document ongoing
the alleged violation of the residents’ re-evaluation of the need for restraints.
rights is confirmed by the facility or if (3) Not employ or otherwise engage
an outside entity having jurisdiction, individuals who—
such as the State Survey Agency, Qual- (i) Have been found guilty of abuse,
ity Improvement Organization, or local neglect, exploitation, misappropriation
law enforcement agency confirms a of property, or mistreatment by a
violation of any of these residents’ court of law;
rights within its area of responsibility; (ii) Have had a finding entered into
and the State nurse aide registry con-
(vii) Maintaining evidence dem- cerning abuse, neglect, exploitation,
onstrating the results of all grievances mistreatment of residents or misappro-
for a period of no less than 3 years from priation of their property; or
the issuance of the grievance decision. (iii) Have a disciplinary action in ef-
(k) Contact with external entities. A fa- fect against his or her professional li-
cility must not prohibit or in any way cense by a state licensure body as a re-
discourage a resident from commu- sult of a finding of abuse, neglect, ex-
nicating with federal, state, or local of- ploitation, mistreatment of residents
ficials, including, but not limited to, or misappropriation of resident prop-
federal and state surveyors, other fed- erty.
eral or state health department em- (4) Report to the State nurse aide
ployees, including representatives of registry or licensing authorities any
the Office of the State Long-Term Care knowledge it has of actions by a court
Ombudsman, and any representative of of law against an employee, which
the agency responsible for the protec- would indicate unfitness for service as
tion and advocacy system for individ- a nurse aide or other facility staff.
uals with mental disorder (established (b) The facility must develop and im-
under the Protection and Advocacy for plement written policies and proce-
Mentally Ill Individuals Act of 2000 (42 dures that:
U.S.C. 10801 et seq.), regarding any mat- (1) Prohibit and prevent abuse, ne-
ter, whether or not subject to arbitra- glect, and exploitation of residents and
tion or any other type of judicial or misappropriation of resident property,
regulatory action. (2) Establish policies and procedures

[81 FR 68849, Oct. 4, 2016, as amended at 82 FR to investigate any such allegations,
32259, July 13, 2017] and
64
(3) Include training as required at with State law through established

paragraph § 483.95. procedures.
(4) Establish coordination with the (2) Have evidence that all alleged vio-
QAPI program required under § 483.75. lations are thoroughly investigated.
(5) Ensure reporting of crimes occur- (3) Prevent further potential abuse,
ring in federally-funded long-term care neglect, exploitation, or mistreatment
facilities in accordance with section while the investigation is in progress.
1150B of the Act. The policies and pro- (4) Report the results of all investiga-
cedures must include but are not lim- tions to the administrator or his or her
ited to the following elements. designated representative and to other
officials in accordance with State law,
(i) Annually notifying covered indi-
including to the State Survey Agency,
viduals, as defined at section
within 5 working days of the incident,
1150B(a)(3) of the Act, of that individ-
and if the alleged violation is verified
ual’s obligation to comply with the fol- appropriate corrective action must be
lowing reporting requirements. taken.
(A) Each covered individual shall re-
port to the State Agency and one or [81 FR 68855, Oct. 4, 2016]
more law enforcement entities for the
§ 483.15 Admission, transfer, and dis-
political subdivision in which the facil- charge rights.
ity is located any reasonable suspicion
of a crime against any individual who (a) Admissions policy. (1) The facility
is a resident of, or is receiving care must establish and implement an ad-
from, the facility. missions policy.
(2) The facility must—
(B) Each covered individual shall re-
(i) Not request or require residents or
port immediately, but not later than 2 potential residents to waive their
hours after forming the suspicion, if rights as set forth in this subpart and
the events that cause the suspicion rein applicable state, federal or local li-
sult in serious bodily injury, or not censing or certification laws, including
later than 24 hours if the events that but not limited to their rights to Medi-
cause the suspicion do not result in se- care or Medicaid; and
rious bodily injury. (ii) Not request or require oral or
(ii) Posting a conspicuous notice of written assurance that residents or po-
employee rights, as defined at section tential residents are not eligible for, or
1150B(d)(3) of the Act. will not apply for, Medicare or Med-
(iii) Prohibiting and preventing re- icaid benefits.
taliation, as defined at section (iii) Not request or require residents
1150B(d)(1) and (2) of the Act. or potential residents to waive poten-
(c) In response to allegations of tial facility liability for losses of per-
abuse, neglect, exploitation, or mis- sonal property
treatment, the facility must: (3) The facility must not request or
(1) Ensure that all alleged violations require a third party guarantee of pay-
involving abuse, neglect, exploitation ment to the facility as a condition of
or mistreatment, including injuries of admission or expedited admission, or
unknown source and misappropriation continued stay in the facility. How-
of resident property, are reported im- ever, the facility may request and re-
mediately, but not later than 2 hours quire a resident representative who has
after the allegation is made, if the legal access to a resident’s income or
events that cause the allegation in- resources available to pay for facility
volve abuse or result in serious bodily care to sign a contract, without incur-
injury, or not later than 24 hours if the ring personal financial liability, to pro-
events that cause the allegation do not vide facility payment from the resi-
involve abuse and do not result in seri- dent’s income or resources.
ous bodily injury, to the administrator (4) In the case of a person eligible for
of the facility and to other officials (in- Medicaid, a nursing facility must not
cluding to the State Survey Agency charge, solicit, accept, or receive, in
and adult protective services where addition to any amount otherwise re-
state law provides for jurisdiction in quired to be paid under the State plan,
long-term care facilities) in accordance any gift, money, donation, or other
65
§ 483.15 42 CFR Ch. IV (10–1–17 Edition)
consideration as a precondition of ad- with the notice requirement in

mission, expedited admission or con- § 483.10(g)(18)(i) and (g)(4)(i) describing
tinued stay in the facility. However,— the charges; and
(i) A nursing facility may charge a (3) The State is not required to offer
resident who is eligible for Medicaid additional services on behalf of a resi-
for items and services the resident has dent other than services provided in
requested and received, and that are the State plan.
not specified in the State plan as in- (c) Transfer and discharge—(1) Facility
cluded in the term ‘‘nursing facility requirements—(i) The facility must per-
services’’ so long as the facility gives mit each resident to remain in the fa-
proper notice of the availability and cility, and not transfer or discharge
cost of these services to residents and the resident from the facility unless—
does not condition the resident’s ad- (A) The transfer or discharge is nec-
mission or continued stay on the re- essary for the resident’s welfare and
quest for and receipt of such additional the resident’s needs cannot be met in
services; and the facility;
(ii) A nursing facility may solicit, ac- (B) The transfer or discharge is ap-
cept, or receive a charitable, religious, propriate because the resident’s health
or philanthropic contribution from an has improved sufficiently so the resi-
organization or from a person unre- dent no longer needs the services pro-
lated to a Medicaid eligible resident or vided by the facility;
potential resident, but only to the ex- (C) The safety of individuals in the
tent that the contribution is not a con- facility is endangered due to the clin-
dition of admission, expedited admis- ical or behavioral status of the resi-
sion, or continued stay in the facility dent;
for a Medicaid eligible resident. (D) The health of individuals in the
(5) States or political subdivisions facility would otherwise be endangered;
may apply stricter admissions stand- (E) The resident has failed, after rea-
ards under State or local laws than are sonable and appropriate notice, to pay
specified in this section, to prohibit for (or to have paid under Medicare or
discrimination against individuals en- Medicaid) a stay at the facility. Non-
titled to Medicaid. payment applies if the resident does
(6) A nursing facility must disclose not submit the necessary paperwork
and provide to a resident or potential for third party payment or after the
resident prior to time of admission, no- third party, including Medicare or
tice of special characteristics or serv- Medicaid, denies the claim and the
ice limitations of the facility. resident refuses to pay for his or her
(7) A nursing facility that is a com- stay. For a resident who becomes eligi-
posite distinct part as defined in § 483.5 ble for Medicaid after admission to a
must disclose in its admission agree- facility, the facility may charge a resi-
ment its physical configuration, in- dent only allowable charges under Med-
cluding the various locations that com- icaid; or
prise the composite distinct part, and (F) The facility ceases to operate.
must specify the policies that apply to (ii) The facility may not transfer or
room changes between its different lo- discharge the resident while the appeal
cations under paragraph (c)(9) of this is pending, pursuant to § 431.230 of this
section. chapter, when a resident exercises his
(b) Equal access to quality care. (1) A or her right to appeal a transfer or dis-
facility must establish, maintain and charge notice from the facility pursu-
implement identical policies and prac- ant to § 431.220(a)(3) of this chapter, un-
tices regarding transfer and discharge, less the failure to discharge or transfer
as defined in § 483.5 and the provision of would endanger the health or safety of
services for all individuals regardless the resident or other individuals in the
of source of payment, consistent with facility. The facility must document
§ 483.10(a)(2); the danger that failure to transfer or
(2) The facility may charge any discharge would pose.
amount for services furnished to non- (2) Documentation. When the facility
Medicaid residents unless otherwise transfers or discharges a resident under
limited by state law and consistent any of the circumstances specified in
66
paragraphs (c)(1)(i)(A) through (F) of (ii) Record the reasons for the trans-
this section, the facility must ensure fer or discharge in the resident’s med-
that the transfer or discharge is docu- ical record in accordance with para-
mented in the resident’s medical graph (c)(2) of this section; and
record and appropriate information is (iii) Include in the notice the items
communicated to the receiving health described in paragraph (c)(5) of this
care institution or provider. section.
(i) Documentation in the resident’s (4) Timing of the notice. (i) Except as
medical record must include: specified in paragraphs (c)(4)(ii) and (8)
(A) The basis for the transfer per of this section, the notice of transfer or
paragraph (c)(1)(i) of this section. discharge required under this section
(B) In the case of paragraph must be made by the facility at least 30
(c)(1)(i)(A) of this section, the specific days before the resident is transferred
resident need(s) that cannot be met, fa- or discharged.
cility attempts to meet the resident (ii) Notice must be made as soon as
needs, and the service available at the practicable before transfer or discharge
receiving facility to meet the need(s). when—
(ii) The documentation required by (A) The safety of individuals in the
paragraph (c)(2)(i) of this section must facility would be endangered under
be made by— paragraph (c)(1)(i)(C) of this section;
(A) The resident’s physician when (B) The health of individuals in the
transfer or discharge is necessary facility would be endangered, under
under paragraph (c)(1)(A) or (B) of this paragraph (c)(1)(i)(D) of this section;
section; and (C) The resident’s health improves
(B) A physician when transfer or dis- sufficiently to allow a more immediate
charge is necessary under paragraph transfer or discharge, under paragraph
(c)(1)(i)(C) or (D) of this section. (c)(1)(i)(B) of this section;
(iii) Information provided to the re- (D) An immediate transfer or dis-
ceiving provider must include a min- charge is required by the resident’s ur-
imum of the following: gent medical needs, under paragraph
(A) Contact information of the prac- (c)(1)(i)(A) of this section; or
titioner responsible for the care of the (E) A resident has not resided in the
resident facility for 30 days.
(B) Resident representative informa- (5) Contents of the notice. The written
tion including contact information. notice specified in paragraph (c)(3) of
(C) Advance Directive information. this section must include the fol-
(D) All special instructions or pre- lowing:
cautions for ongoing care, as appro- (i) The reason for transfer or dis-
priate. charge;
(E) Comprehensive care plan goals, (ii) The effective date of transfer or
(F) All other necessary information, discharge;
including a copy of the resident’s dis- (iii) The location to which the resi-
charge summary, consistent with dent is transferred or discharged;
§ 483.21(c)(2), as applicable, and any (iv) A statement of the resident’s ap-
other documentation, as applicable, to peal rights, including the name, ad-
ensure a safe and effective transition of dress (mailing and email), and tele-
care. phone number of the entity which re-
(3) Notice before transfer. Before a fa- ceives such requests; and information
cility transfers or discharges a resi- on how to obtain an appeal form and
dent, the facility must— assistance in completing the form and
(i) Notify the resident and the resi- submitting the appeal hearing request;
dent’s representative(s) of the transfer (v) The name, address (mailing and
or discharge and the reasons for the email) and telephone number of the Of-
move in writing and in a language and fice of the State Long-Term Care Om-
manner they understand. The facility budsman;
must send a copy of the notice to a rep- (vi) For nursing facility residents
resentative of the Office of the State with intellectual and developmental
Long-Term Care Ombudsman. disabilities or related disabilities, the
67
§ 483.15 42 CFR Ch. IV (10–1–17 Edition)
mailing and email address and tele- therapeutic leave, the nursing facility
phone number of the agency respon- must provide written information to
sible for the protection and advocacy of the resident or resident representative
individuals with developmental disabil- that specifies—
ities established under Part C of the (i) The duration of the state bed-hold
Developmental Disabilities Assistance policy, if any, during which the resi-
and Bill of Rights Act of 2000 (Pub. L. dent is permitted to return and resume
106–402, codified at 42 U.S.C. 15001 et residence in the nursing facility;
seq.); and (ii) The reserve bed payment policy
(vii) For nursing facility residents in the state plan, under § 447.40 of this
with a mental disorder or related dis- chapter, if any;
abilities, the mailing and email address (iii) The nursing facility’s policies re-
and telephone number of the agency regarding bed-hold periods, which must
sponsible for the protection and advo- be consistent with paragraph (e)(1) of
cacy of individuals with a mental dis- this section, permitting a resident to
order established under the Protection return; and
and Advocacy for Mentally Ill Individ- (iv) The information specified in
uals Act. paragraph (e)(1) of this section.
(6) Changes to the notice. If the infor- (2) Bed-hold notice upon transfer. At
mation in the notice changes prior to the time of transfer of a resident for
effecting the transfer or discharge, the hospitalization or therapeutic leave, a
facility must update the recipients of nursing facility must provide to the
the notice as soon as practicable once resident and the resident representa-
the updated information becomes tive written notice which specifies the
available. duration of the bed-hold policy de-
(7) Orientation for transfer or dis- scribed in paragraph (d)(1) of this sec-
charge. A facility must provide and tion.
document sufficient preparation and (e)(1) Permitting residents to return to
orientation to residents to ensure safe facility. A facility must establish and
and orderly transfer or discharge from follow a written policy on permitting
the facility. This orientation must be residents to return to the facility after
provided in a form and manner that the they are hospitalized or placed on
resident can understand. therapeutic leave. The policy must pro-
(8) Notice in advance of facility closure. vide for the following.
In the case of facility closure, the indi- (i) A resident, whose hospitalization
vidual who is the administrator of the or therapeutic leave exceeds the bed-
facility must provide written notifica- hold period under the State plan, re-
tion prior to the impending closure to turns to the facility to their previous
the State Survey Agency, the Office of room if available or immediately upon
the State Long-Term Care Ombuds- the first availability of a bed in a semi-
man, residents of the facility, and the private room if the resident
resident representatives, as well as the (A) Requires the services provided by
plan for the transfer and adequate relo- the facility; and
cation of the residents, as required at (B) Is eligible for Medicare skilled
§ 483.70(l). nursing facility services or Medicaid
(9) Room changes in a composite dis- nursing facility services.
tinct part. Room changes in a facility (ii) If the facility that determines
that is a composite distinct part (as de- that a resident who was transferred
fined in § 483.5) are subject to the re- with an expectation of returning to the
quirements of § 483.10(e)(7) and must be facility cannot return to the facility,
limited to moves within the particular the facility must comply with the re-
building in which the resident resides, quirements of paragraph (c) as they
unless the resident voluntarily agrees apply to discharges.
to move to another of the composite (2) Readmission to a composite distinct
distinct part’s locations. part. When the facility to which a resi-
(d) Notice of bed-hold policy and re- dent returns is a composite distinct
turn—(1) Notice before transfer. Before a part (as defined in § 483.5), the resident
nursing facility transfers a resident to must be permitted to return to an
a hospital or the resident goes on available bed in the particular location
68
of the composite distinct part in which censed and nonlicensed direct care
he or she resided previously. If a bed is staff members on all shifts.
not available in that location at the (2) When required. Subject to the
time of return, the resident must be timeframes prescribed in § 413.343(b) of
given the option to return to that loca- this chapter, a facility must conduct a
tion upon the first availability of a bed comprehensive assessment of a resident
there. in accordance with the timeframes
[81 FR 68855, Oct. 4, 2016, as amended at 82 FR
specified in paragraphs (b)(2) (i)
32259, July 13, 2017] through (iii) of this section. The time-
frames prescribed in § 413.343(b) of this
§ 483.20 Resident assessment. chapter do not apply to CAHs.
The facility must conduct initially (i) Within 14 calendar days after ad-
and periodically a comprehensive, ac- mission, excluding readmissions in
curate, standardized, reproducible as- which there is no significant change in
sessment of each resident’s functional the resident’s physical or mental con-
capacity. dition. (For purposes of this section,
(a) Admission orders. At the time each ‘‘readmission’’ means a return to the
resident is admitted, the facility must facility following a temporary absence
have physician orders for the resident’s for hospitalization or for therapeutic
immediate care. leave.)
(b) Comprehensive assessments—(1) (ii) Within 14 calendar days after the
Resident assessment instrument. A facil- facility determines, or should have de-
ity must make a comprehensive assess- termined, that there has been a signifi-
ment of a resident’s needs, strengths, cant change in the resident’s physical
goals, life history and preferences, or mental condition. (For purposes of
using the resident assessment instru- this section, a ‘‘significant change’’
ment (RAI) specified by CMS. The as- means a major decline or improvement
sessment must include at least the fol- in the resident’s status that will not
lowing: normally resolve itself without further
(i) Identification and demographic in- intervention by staff or by imple-
formation. menting standard disease-related clin-
(ii) Customary routine. ical interventions, that has an impact
(iii) Cognitive patterns. on more than one area of the resident’s
(iv) Communication. health status, and requires inter-
(v) Vision. disciplinary review or revision of the
(vi) Mood and behavior patterns. care plan, or both.)
(vii) Psychosocial well-being. (iii) Not less often than once every 12
(viii) Physical functioning and struc- months.
tural problems. (c) Quarterly review assessment. A fa-
(ix) Continence. cility must assess a resident using the
(x) Disease diagnoses and health con- quarterly review instrument specified
ditions. by the State and approved by CMS not
(xi) Dental and nutritional status. less frequently than once every 3
(xii) Skin condition. months.
(xiii) Activity pursuit. (d) Use. A facility must maintain all
(xiv) Medications. resident assessments completed within
(xv) Special treatments and proce- the previous 15 months in the resi-
dures. dent’s active record and use the results
(xvi) Discharge planning. of the assessments to develop, review,
(xvii) Documentation of summary in- and revise the resident’s comprehen-
formation regarding the additional as- sive plan of care.
sessment performed on the care areas (e) Coordination. A facility must co-
triggered by the completion of the ordinate assessments with the
Minimum Data Set (MDS). preadmission screening and resident re-
(xviii) Documentation of participa- view (PASARR) program under Med-
tion in assessment. The assessment icaid in subpart C of this part to the
process must include direct observa- maximum extent practicable to avoid

tion and communication with the resi- duplicative testing and effort. Coordi-
dent, as well as communication with li- nation includes—
69
§ 483.20 42 CFR Ch. IV (10–1–17 Edition)
(1) Incorporating the recommenda- MDS data on a resident that does not
tions from the PASARR level II deter- have an admission assessment.
mination and the PASARR evaluation (4) Data format. The facility must
report into a resident’s assessment, transmit data in the format specified
care planning, and transitions of care. by CMS or, for a State which has an al-
(2) Referring all level II residents and ternate RAI approved by CMS, in the
all residents with newly evident or pos- format specified by the State and ap-
sible serious mental disorder, intellec- proved by CMS.
tual disability, or a related condition (5) Resident-identifiable information. (i)
for level II resident review upon a sig- A facility may not release information
nificant change in status assessment. that is resident-identifiable to the pub-
(f) Automated data processing require- lic.
ment—(1) Encoding data. Within 7 days (ii) The facility may release informa-
after a facility completes a resident’s tion that is resident-identifiable to an
assessment, a facility must encode the agent only in accordance with a con-
following information for each resident tract under which the agent agrees not
in the facility: to use or disclose the information ex-
(i) Admission assessment. cept to the extent the facility itself is
(ii) Annual assessment updates. permitted to do so.
(iii) Significant change in status as- (g) Accuracy of assessments. The as-
sessments. sessment must accurately reflect the
(iv) Quarterly review assessments. resident’s status.
(v) A subset of items upon a resi- (h) Coordination. A registered nurse
dent’s transfer, reentry, discharge, and must conduct or coordinate each as-
death. sessment with the appropriate partici-
pation of health professionals.
(vi) Background (face-sheet) informa-
(i) Certification. (1) A registered nurse
tion, if there is no admission assess-
must sign and certify that the assess-
ment.
ment is completed.
(2) Transmitting data. Within 7 days
(2) Each individual who completes a
after a facility completes a resident’s
portion of the assessment must sign
assessment, a facility must be capable
and certify the accuracy of that por-
of transmitting to the CMS System in-
tion of the assessment.
formation for each resident contained
(j) Penalty for falsification. (1) Under
in the MDS in a format that conforms
Medicare and Medicaid, an individual
to standard record layouts and data
who willfully and knowingly—
dictionaries, and that passes standard-
(i) Certifies a material and false
ized edits defined by CMS and the
statement in a resident assessment is
State.
subject to a civil money penalty of not
(3) Transmittal requirements. Within 14 more than $1,000 as adjusted annually
days after a facility completes a resi- under 45 CFR part 102 for each assess-
dent’s assessment, a facility must elec- ment; or
tronically transmit encoded, accurate, (ii) Causes another individual to cer-
and complete MDS data to the CMS tify a material and false statement in a
System, including the following: resident assessment is subject to a civil
(i) Admission assessment. money penalty of not more than $5,000
(ii) Annual assessment. as adjusted annually under 45 CFR part
(iii) Significant change in status as- 102 for each assessment.
sessment. (2) Clinical disagreement does not
(iv) Significant correction of prior constitute a material and false state-
full assessment. ment.
(v) Significant correction of prior (k) Preadmission screening for individ-
quarterly assessment. uals with a mental disorder and individ-
(vi) Quarterly review. uals with intellectual disability. (1) A
(vii) A subset of items upon a resi- nursing facility must not admit, on or
dent’s transfer, reentry, discharge, and after January 1, 1989, any new resident
death. with—
(viii) Background (face-sheet) infor- (i) Mental disorder as defined in para-
mation, for an initial transmission of graph (k)(3)(i) of this section, unless
70
the State mental health authority has (ii) An individual is considered to

determined, based on an independent have an intellectual disability if the
physical and mental evaluation per- individual has an intellectual dis-
formed by a person or entity other ability as defined in § 483.102(b)(3) or is
than the State mental health author- a person with a related condition as de-
ity, prior to admission, scribed in § 435.1010 of this chapter.
(A) That, because of the physical and (4) A nursing facility must notify the
mental condition of the individual, the state mental health authority or state
individual requires the level of services intellectual disability authority, as ap-
provided by a nursing facility; and plicable, promptly after a significant
(B) If the individual requires such change in the mental or physical condi-
level of services, whether the indi- tion of a resident who has a mental dis-
vidual requires specialized services; or order or intellectual disability for resi-
(ii) Intellectual disability, as defined dent review.
in paragraph (k)(3)(ii) of this section, [56 FR 48871, Sept. 26, 1991, as amended at 57
unless the State intellectual disability FR 43924, Sept. 23, 1992; 62 FR 67211, Dec. 23,
or developmental disability authority 1997; 63 FR 53307, Oct. 5, 1998; 64 FR 41543,
has determined prior to admission— July 30, 1999; 68 FR 46072, Aug. 4, 2003; 71 FR
(A) That, because of the physical and 39229, July 12, 2006; 74 FR 40363, Aug. 11, 2009;
mental condition of the individual, the 81 FR 61563, Sept. 6, 2016; 81 FR 68857, Oct. 4,
2016]
individual requires the level of services
provided by a nursing facility; and § 483.21 Comprehensive person-cen-
(B) If the individual requires such tered care planning.
level of services, whether the indi-
(a) Baseline care plans. (1) The facility
vidual requires specialized services for
must develop and implement a baseline
intellectual disability.
care plan for each resident that in-
(2) Exceptions. For purposes of this cludes the instructions needed to pro-
section— vide effective and person-centered care
(i) The preadmission screening proof the resident that meet professional
gram under paragraph (k)(1) of this sec- standards of quality care. The baseline
tion need not provide for determina- care plan must—
tions in the case of the readmission to (i) Be developed within 48 hours of a
a nursing facility of an individual who, resident’s admission.
after being admitted to the nursing fa- (ii) Include the minimum healthcare
cility, was transferred for care in a information necessary to properly care
hospital. for a resident including, but not lim-
(ii) The State may choose not to ited to:
apply the preadmission screening pro- (A) Initial goals based on admission
gram under paragraph (k)(1) of this sec- orders.
tion to the admission to a nursing fa- (B) Physician orders.
cility of an individual— (C) Dietary orders.
(A) Who is admitted to the facility (D) Therapy services.
directly from a hospital after receiving (E) Social services.
acute inpatient care at the hospital, (F) PASARR recommendation, if ap-
(B) Who requires nursing facility plicable.
services for the condition for which the (2) The facility may develop a com-
individual received care in the hos- prehensive care plan in place of the
pital, and baseline care plan if the comprehensive
(C) Whose attending physician has care plan—
certified, before admission to the facil- (i) Is developed within 48 hours of the
ity that the individual is likely to re- resident’s admission.
quire less than 30 days of nursing facil- (ii) Meets the requirements set forth
ity services. in paragraph (b) of this section (except-
(3) Definition. For purposes of this ing paragraph (b)(2)(i) of this section).
section— (3) The facility must provide the resi-
(i) An individual is considered to dent and their representative with a
have a mental disorder if the indi- summary of the baseline care plan that
vidual has a serious mental disorder as includes but is not limited to:
defined in § 483.102(b)(1). (i) The initial goals of the resident.
71
§ 483.21 42 CFR Ch. IV (10–1–17 Edition)
(ii) A summary of the resident’s (i) Developed within 7 days after

medications and dietary instructions. completion of the comprehensive as-
(iii) Any services and treatments to sessment.
be administered by the facility and (ii) Prepared by an interdisciplinary
personnel acting on behalf of the facil- team, that includes but is not limited
ity. to—
(iv) Any updated information based (A) The attending physician.
on the details of the comprehensive (B) A registered nurse with responsi-
care plan, as necessary. bility for the resident.
(b) Comprehensive care plans. (1) The (C) A nurse aide with responsibility
facility must develop and implement a for the resident.
comprehensive person-centered care (D) A member of food and nutrition
plan for each resident, consistent with services staff.
the resident rights set forth at (E) To the extent practicable, the
§ 483.10(c)(2) and § 483.10(c)(3), that in- participation of the resident and the
cludes measurable objectives and time- resident’s representative(s). An expla-
frames to meet a resident’s medical, nation must be included in a resident’s
nursing, and mental and psychosocial medical record if the participation of
needs that are identified in the com- the resident and their resident rep-
prehensive assessment. The com- resentative is determined not prac-
prehensive care plan must describe the ticable for the development of the resi-
following: dent’s care plan.
(i) The services that are to be fur- (F) Other appropriate staff or profes-
nished to attain or maintain the resi- sionals in disciplines as determined by
dent’s highest practicable physical, the resident’s needs or as requested by
mental, and psychosocial well-being as the resident.
required under § 483.24, § 483.25, or (iii) Reviewed and revised by the
§ 483.40; and interdisciplinary team after each as-
(ii) Any services that would other- sessment, including both the com-
wise be required under § 483.24, § 483.25, prehensive and quarterly review assess-
or § 483.40 but are not provided due to ments.
the resident’s exercise of rights under (3) The services provided or arranged
§ 483.10, including the right to refuse by the facility, as outlined by the com-
treatment under § 483.10(c)(6). prehensive care plan, must—
(iii) Any specialized services or spe- (i) Meet professional standards of
cialized rehabilitative services the quality.
nursing facility will provide as a result (ii) Be provided by qualified persons
of PASARR recommendations. If a fa- in accordance with each resident’s
cility disagrees with the findings of the written plan of care.
PASARR, it must indicate its rationale (iii) Be culturally-competent and
in the resident’s medical record. trauma–informed.
(iv) In consultation with the resident (c) Discharge planning—(1) Discharge
and the resident’s representative(s)— planning process. The facility must de-
(A) The resident’s goals for admission velop and implement an effective dis-
and desired outcomes. charge planning process that focuses
(B) The resident’s preference and po- on the resident’s discharge goals, the
tential for future discharge. Facilities preparation of residents to be active
must document whether the resident’s partners and effectively transition
desire to return to the community was them to post-discharge care, and the
assessed and any referrals to local con- reduction of factors leading to prevent-
tact agencies and/or other appropriate able readmissions. The facility’s dis-
entities, for this purpose. charge planning process must be con-
(C) Discharge plans in the com- sistent with the discharge rights set
prehensive care plan, as appropriate, in forth at § 483.15(b) as applicable and—
accordance with the requirements set (i) Ensure that the discharge needs of
forth in paragraph (c) of this section. each resident are identified and result
(2) A comprehensive care plan must in the development of a discharge plan
be— for each resident.
72
(ii) Include regular re-evaluation of resident’s goals of care and treatment

residents to identify changes that re- preferences.
quire modification of the discharge (ix) Document, complete on a timely
plan. The discharge plan must be up- basis based on the resident’s needs, and
dated, as needed, to reflect these include in the clinical record, the eval-
changes. uation of the resident’s discharge needs
(iii) Involve the interdisciplinary and discharge plan. The results of the
team, as defined by § 483.21(b)(2)(ii), in evaluation must be discussed with the
the ongoing process of developing the resident or resident’s representative.
discharge plan. All relevant resident information must
(iv) Consider caregiver/support per- be incorporated into the discharge plan
son availability and the resident’s or to facilitate its implementation and to
caregiver’s/support person(s) capacity avoid unnecessary delays in the resi-
and capability to perform required dent’s discharge or transfer.
care, as part of the identification of (2) Discharge summary. When the fa-
discharge needs. cility anticipates discharge a resident
(v) Involve the resident and resident must have a discharge summary that
representative in the development of includes, but is not limited to, the fol-
the discharge plan and inform the resi- lowing:
dent and resident representative of the (i) A recapitulation of the resident’s
final plan. stay that includes, but is not limited
(vi) Address the resident’s goals of to, diagnoses, course of illness/treat-
care and treatment preferences. ment or therapy, and pertinent lab, ra-
diology, and consultation results.
(vii) Document that a resident has
been asked about their interest in re- (ii) A final summary of the resident’s
ceiving information regarding return- status to include items in paragraph
ing to the community. (b)(1) of § 483.20, at the time of the dis-
charge that is available for release to
(A) If the resident indicates an inter-
authorized persons and agencies, with
est in returning to the community, the
the consent of the resident or resi-
facility must document any referrals
dent’s representative.
to local contact agencies or other ap-
(iii) Reconciliation of all pre-dis-
propriate entities made for this pur-
charge medications with the resident’s
pose.
post-discharge medications (both pre-
(B) Facilities must update a resi- scribed and over-the-counter).
dent’s comprehensive care plan and dis-
(iv) A post-discharge plan of care
charge plan, as appropriate, in response
that is developed with the participa-
to information received from referrals
tion of the resident and, with the resi-
to local contact agencies or other ap-
dent’s consent, the resident representa-
propriate entities.
tive(s), which will assist the resident to
(C) If discharge to the community is adjust to his or her new living environ-
determined to not be feasible, the facil- ment. The post-discharge plan of care
ity must document who made the de- must indicate where the individual
termination and why. plans to reside, any arrangements that
(viii) For residents who are trans- have been made for the resident’s fol-
ferred to another SNF or who are dis- low up care and any post-discharge
charged to a HHA, IRF, or LTCH, assist medical and non-medical services.
residents and their resident representa-
tives in selecting a post-acute care pro- [81 FR 68858, Oct. 4, 2016]
vider by using data that includes, but
is not limited to SNF, HHA, IRF, or § 483.24 Quality of life.
LTCH standardized patient assessment Quality of life is a fundamental prin-
data, data on quality measures, and ciple that applies to all care and serv-
data on resource use to the extent the ices provided to facility residents.
data is available. The facility must en- Each resident must receive and the fa-
sure that the post-acute care standard- cility must provide the necessary care
ized patient assessment data, data on and services to attain or maintain the
quality measures, and data on resource highest practicable physical, mental,
use is relevant and applicable to the and psychosocial well-being, consistent
73
§ 483.25 42 CFR Ch. IV (10–1–17 Edition)
with the resident’s comprehensive as- aging both independence and inter-
sessment and plan of care. action in the community.
(a) Based on the comprehensive as- (2) The activities program must be
sessment of a resident and consistent directed by a qualified professional
with the resident’s needs and choices, who is a qualified therapeutic recre-
the facility must provide the necessary ation specialist or an activities profes-
care and services to ensure that a resi- sional who—
dent’s abilities in activities of daily (i) Is licensed or registered, if appli-
living do not diminish unless cir- cable, by the State in which practicing;
cumstances of the individual’s clinical and
condition demonstrate that such dimi- (ii) Is:
nution was unavoidable. This includes (A) Eligible for certification as a
the facility ensuring that: therapeutic recreation specialist or as
(1) A resident is given the appro- an activities professional by a recog-
priate treatment and services to main- nized accrediting body on or after Oc-
tain or improve his or her ability to tober 1, 1990; or
carry out the activities of daily living, (B) Has 2 years of experience in a so-
including those specified in paragraph cial or recreational program within the
(b) of this section, last 5 years, one of which was full-time
(2) A resident who is unable to carry in a therapeutic activities program; or
out activities of daily living receives (C) Is a qualified occupational thera-
the necessary services to maintain pist or occupational therapy assistant;
good nutrition, grooming, and personal or
and oral hygiene, and (D) Has completed a training course
(3) Personnel provide basic life sup- approved by the State.
port, including CPR, to a resident re- [81 FR 68859, Oct. 4, 2016]
quiring such emergency care prior to
the arrival of emergency medical per- § 483.25 Quality of care.
sonnel and subject to related physician Quality of care is a fundamental
orders and the resident’s advance direc- principle that applies to all treatment
tives. and care provided to facility residents.
(b) Activities of daily living. The facil- Based on the comprehensive assess-
ity must provide care and services in ment of a resident, the facility must
accordance with paragraph (a) of this ensure that residents receive treat-
section for the following activities of ment and care in accordance with pro-
daily living: fessional standards of practice, the
(1) Hygiene—bathing, dressing, comprehensive person-centered care
grooming, and oral care, plan, and the resident’s choices, includ-
(2) Mobility—transfer and ambula- ing but not limited to the following:
tion, including walking, (a) Vision and hearing. To ensure that
(3) Elimination—toileting, residents receive proper treatment and
(4) Dining—eating, including meals assistive devices to maintain vision
and snacks, and hearing abilities, the facility must,
(5) Communication, including if necessary, assist the resident—
(i) Speech, (1) In making appointments, and
(ii) Language, (2) By arranging for transportation
(iii) Other functional communication to and from the office of a practitioner
systems. specializing in the treatment of vision
(c) Activities. (1) The facility must or hearing impairment or the office of
provide, based on the comprehensive a professional specializing in the provi-
assessment and care plan and the pref- sion of vision or hearing assistive de-
erences of each resident, an ongoing vices.
program to support residents in their (b) Skin integrity—(1) Pressure ulcers.
choice of activities, both facility-spon- Based on the comprehensive assess-
sored group and individual activities ment of a resident, the facility must
and independent activities, designed to ensure that—
meet the interests of and support the (i) A resident receives care, con-
physical, mental, and psychosocial sistent with professional standards of
well-being of each resident, encour- practice, to prevent pressure ulcers and
74
does not develop pressure ulcers unless (2) For a resident with urinary incon-
the individual’s clinical condition dem- tinence, based on the resident’s com-
onstrates that they were unavoidable; prehensive assessment, the facility
and must ensure that—
(ii) A resident with pressure ulcers (i) A resident who enters the facility
receives necessary treatment and serv- without an indwelling catheter is not
ices, consistent with professional catheterized unless the resident’s clin-
standards of practice, to promote heal- ical condition demonstrates that cath-
ing, prevent infection and prevent new eterization was necessary;
ulcers from developing. (ii) A resident who enters the facility
(2) Foot care. To ensure that residents with an indwelling catheter or subse-
receive proper treatment and care to quently receives one is assessed for re-
maintain mobility and good foot moval of the catheter as soon as pos-
health, the facility must— sible unless the resident’s clinical con-
(i) Provide foot care and treatment, dition demonstrates that catheteriza-
in accordance with professional stand- tion is necessary, and
ards of practice, including to prevent (iii) A resident who is incontinent of
complications from the resident’s med- bladder receives appropriate treatment
ical condition(s) and and services to prevent urinary tract
(ii) If necessary, assist the resident in infections and to restore continence to
making appointments with a qualified the extent possible.
person, and arranging for transpor- (3) For a resident with fecal inconti-
tation to and from such appointments. nence, based on the resident’s com-
prehensive assessment, the facility
(c) Mobility. (1) The facility must en-
must ensure that a resident who is in-
sure that a resident who enters the fa-
continent of bowel receives appropriate
cility without limited range of motion
treatment and services to restore as
does not experience reduction in range
much normal bowel function as pos-
of motion unless the resident’s clinical
sible.
condition demonstrates that a reduc-
(f) Colostomy, urostomy, or ileostomy
tion in range of motion is unavoidable;
care. The facility must ensure that
and
residents who require colostomy,
(2) A resident with limited range of
urostomy, or ileostomy services, re-
motion receives appropriate treatment
ceive such care consistent with profes-
and services to increase range of mo-
sional standards of practice, the com-
tion and/or to prevent further decrease
prehensive person-centered care plan,
in range of motion.
and the residents’ goals and pref-
(3) A resident with limited mobility erences.
receives appropriate services, equip- (g) Assisted nutrition and hydration.
ment, and assistance to maintain or (Includes naso-gastric and gastrostomy
improve mobility with the maximum tubes, both percutaneous endoscopic
practicable independence unless a re- gastrostomy and percutaneous
duction in mobility is demonstrably endoscopic jejunostomy, and enteral
unavoidable. fluids). Based on a resident’s com-
(d) Accidents.The facility must ensure prehensive assessment, the facility
that— must ensure that a resident—
(1) The resident environment remains (1) Maintains acceptable parameters
as free of accident hazards as is pos- of nutritional status, such as usual
sible; and body weight or desirable body weight
(2) Each resident receives adequate range and electrolyte balance, unless
supervision and assistance devices to the resident’s clinical condition dem-
prevent accidents. onstrates that this is not possible or
(e) Incontinence. (1) The facility must resident preferences indicate other-
ensure that a resident who is continent wise;
of bladder and bowel on admission re- (2) Is offered sufficient fluid intake to
ceives services and assistance to main- maintain proper hydration and health;
tain continence unless his or her clin- and

ical condition is or becomes such that (3) Is offered a therapeutic diet when
continence is not possible to maintain. there is a nutritional problem and the
75
§ 483.30 42 CFR Ch. IV (10–1–17 Edition)
health care provider orders a thera- (m) Trauma-informed care. The facil-
peutic diet. ity must ensure that residents who are
(4) A resident who has been able to trauma survivors receive culturally-
eat enough alone or with assistance is competent, trauma-informed care in
not fed by enteral methods unless the accordance with professional standards
resident’s clinical condition dem- of practice and accounting for resi-
onstrates that enteral feeding was dents’ experiences and preferences in
clinically indicated and consented to order to eliminate or mitigate triggers
by the resident; and that may cause re-traumatization of
(5) A resident who is fed by enteral the resident.
means receives the appropriate treat- (n) Bed rails. The facility must at-
ment and services to restore, if pos- tempt to use appropriate alternatives
sible, oral eating skills and to prevent prior to installing a side or bed rail. If
complications of enteral feeding in- a bed or side rail is used, the facility
cluding but not limited to aspiration must ensure correct installation, use,
pneumonia, diarrhea, vomiting, dehy- and maintenance of bed rails, including
dration, metabolic abnormalities, and but not limited to the following ele-
nasal-pharyngeal ulcers. ments.
(h) Parenteral fluids. Parenteral fluids (1) Assess the resident for risk of en-
must be administered consistent with trapment from bed rails prior to instal-
professional standards of practice and lation.
in accordance with physician orders, (2) Review the risks and benefits of
the comprehensive person-centered bed rails with the resident or resident
care plan, and the resident’s goals and representative and obtain informed
preferences. consent prior to installation.
(3) Ensure that the bed’s dimensions
(i) Respiratory care, including trache-
are appropriate for the resident’s size
ostomy care and tracheal suctioning. The
and weight.
facility must ensure that a resident
(4) Follow the manufacturers’ rec-
who needs respiratory care, including
ommendations and specifications for
tracheostomy care and tracheal
installing and maintaining bed rails.
suctioning, is provided such care, con-
sistent with professional standards of [81 FR 68860, Oct. 4, 2016]
practice, the comprehensive person-
centered care plan, the residents’ goals § 483.30 Physician services.
and preferences, and § 483.65 of this sub- A physician must personally approve
part. in writing a recommendation that an
(j) Prostheses. The facility must en- individual be admitted to a facility.
sure that a resident who has a pros- Each resident must remain under the
thesis is provided care and assistance, care of a physician. A physician, physi-
consistent with professional standards cian assistant, nurse practitioner, or
of practice, the comprehensive person- clinical nurse specialist must provide
centered care plan, and the residents’ orders for the resident’s immediate
goals and preferences, to wear and be care and needs.
able to use the prosthetic device. (a) Physician supervision. The facility
(k) Pain management. The facility must ensure that—
must ensure that pain management is (1) The medical care of each resident
provided to residents who require such is supervised by a physician; and
services, consistent with professional (2) Another physician supervises the
standards of practice, the comprehen- medical care of residents when their
sive person-centered care plan, and the attending physician is unavailable.
residents’ goals and preferences. (b) Physician visits. The physician
(l) Dialysis. The facility must ensure must—
that residents who require dialysis re- (1) Review the resident’s total pro-
ceive such services, consistent with gram of care, including medications
professional standards of practice, the and treatments, at each visit required
comprehensive person-centered care by paragraph (c) of this section;

plan, and the residents’ goals and pref- (2) Write, sign, and date progress
erences. notes at each visit; and
76
(3) Sign and date all orders with the (i) Is acting within the scope of prac-
exception of influenza and pneumo- tice as defined by State law; and
coccal vaccines, which may be adminis- (ii) Is under the supervision of the
tered per physician-approved facility physician.
policy after an assessment for contra- (4) A physician may not delegate a
indications. task when the regulations specify that
(c) Frequency of physician visits. (1) the physician must perform it person-
The resident must be seen by a physi- ally, or when the delegation is prohib-
cian at least once every 30 days for the ited under State law or by the facili-
first 90 days after admission, and at ty’s own policies.
least once every 60 days thereafter. (f) Performance of physician tasks in
(2) A physician visit is considered NFs. At the option of the State, any re-
timely if it occurs not later than 10 quired physician task in a NF (includ-
days after the date the visit was re- ing tasks which the regulations specify
quired. must be performed personally by the
(3) Except as provided in paragraphs physician) may also be satisfied when
(c)(4) and (f) of this section, all re- performed by a nurse practitioner, clin-
quired physician visits must be made ical nurse specialist, or physician as-
by the physician personally. sistant who is not an employee of the
facility but who is working in collabo-
(4) At the option of the physician, re-
ration with a physician.
quired visits in SNFs after the initial
visit may alternate between personal [56 FR 48875, Sept. 26, 1991, as amended at 67
visits by the physician and visits by a FR 61814, Oct. 2, 2002. Redesignated and
physician assistant, nurse practitioner, amended at 81 FR 68861, Oct. 4, 2016]
or clinical nurse specialist in accord-
§ 483.35 Nursing services.
ance with paragraph (e) of this section.
(d) Availability of physicians for emer- The facility must have sufficient
gency care. The facility must provide or nursing staff with the appropriate com-
arrange for the provision of physician petencies and skills sets to provide
services 24 hours a day, in case of an nursing and related services to assure
emergency. resident safety and attain or maintain
(e) Physician delegation of tasks in the highest practicable physical, men-
SNFs. (1) Except as specified in para- tal, and psychosocial well-being of each
graph (e)(4) of this section, a physician resident, as determined by resident as-
may delegate tasks to a physician assessments and individual plans of care
sistant, nurse practitioner, or clinical and considering the number, acuity
nurse specialist who— and diagnoses of the facility’s resident
(i) Meets the applicable definition in population in accordance with the fa-
§ 491.2 of this chapter or, in the case of cility assessment required at § 483.70(e).
(a) Sufficient staff. (1) The facility
a clinical nurse specialist, is licensed
must provide services by sufficient
as such by the State;
numbers of each of the following types
(ii) Is acting within the scope of prac-
of personnel on a 24-hour basis to pro-
tice as defined by State law; and
vide nursing care to all residents in ac-
(iii) Is under the supervision of the cordance with resident care plans:
physician. (i) Except when waived under para-
(2) A resident’s attending physician graph (e) of this section, licensed
may delegate the task of writing die- nurses; and
tary orders, consistent with § 483.60, to (ii) Other nursing personnel, includ-
a qualified dietitian or other clinically ing but not limited to nurse aides.
qualified nutrition professional who— (2) Except when waived under para-
(i) Is acting within the scope of prac- graph (c) of this section, the facility
tice as defined by State law; and must designate a licensed nurse to
(ii) Is under the supervision of the serve as a charge nurse on each tour of
physician. duty.
(3) A resident’s attending physician (3) The facility must ensure that li-
may delegate the task of writing ther- censed nurses have the specific com-
apy orders, consistent with § 483.65, to a petencies and skill sets necessary to
qualified therapist who— care for residents’ needs, as identified
77
§ 483.35 42 CFR Ch. IV (10–1–17 Edition)
through resident assessments, and de- (i) Is a full-time employee in a State-

scribed in the plan of care. approved training and competency
(4) Providing care includes but is not evaluation program;
limited to assessing, evaluating, plan- (ii) Has demonstrated competence
ning and implementing resident care through satisfactory participation in a
plans and responding to resident’s State-approved nurse aide training and
needs. competency evaluation program or
(b) Registered nurse. (1) Except when competency evaluation program; or
waived under paragraph (e) or (f) of (iii) Has been deemed or determined
this section, the facility must use the competent as provided in § 483.150(a)
services of a registered nurse for at and (b).
least 8 consecutive hours a day, 7 days (4) Registry verification. Before allow-
a week. ing an individual to serve as a nurse
(2) Except when waived under para- aide, a facility must receive registry
graph (e) or (f) of this section, the fa- verification that the individual has
cility must designate a registered met competency evaluation require-
nurse to serve as the director of nurs- ments unless—
ing on a full time basis. (i) The individual is a full-time em-
(3) The director of nursing may serve ployee in a training and competency
as a charge nurse only when the facil- evaluation program approved by the
ity has an average daily occupancy of State; or
60 or fewer residents. (ii) The individual can prove that he
(c) Proficiency of nurse aides. The fa- or she has recently successfully com-
cility must ensure that nurse aides are pleted a training and competency eval-
able to demonstrate competency in uation program or competency evalua-
skills and techniques necessary to care tion program approved by the State
for residents’ needs, as identified and has not yet been included in the
through resident assessments, and de- registry. Facilities must follow up to
scribed in the plan of care. ensure that such an individual actually
(d) Requirements for facility hiring and becomes registered.
use of nursing aides—(1) General rule. A (5) Multi-State registry verification. Be-
facility must not use any individual fore allowing an individual to serve as
working in the facility as a nurse aide a nurse aide, a facility must seek infor-
for more than 4 months, on a full-time mation from every State registry es-
basis, unless— tablished under sections 1819(e)(2)(A) or
(i) That individual is competent to 1919(e)(2)(A) of the Act that the facility
provide nursing and nursing related believes will include information on
services; and the individual.
(ii)(A) That individual has completed (6) Required retraining. If, since an in-
a training and competency evaluation dividual’s most recent completion of a
program, or a competency evaluation training and competency evaluation
program approved by the State as program, there has been a continuous
meeting the requirements of §§ 483.151 period of 24 consecutive months during
through 483.154; or none of which the individual provided
(B) That individual has been deemed nursing or nursing-related services for
or determined competent as provided monetary compensation, the individual
in § 483.150(a) and (b). must complete a new training and com-
(2) Non-permanent employees. A facil- petency evaluation program or a new
ity must not use on a temporary, per competency evaluation program.
diem, leased, or any basis other than a (7) Regular in-service education. The
permanent employee any individual facility must complete a performance
who does not meet the requirements in review of every nurse aide at least once
paragraphs (d)(1) (i) and (ii) of this sec- every 12 months, and must provide reg-
tion. ular in-service education based on the
(3) Minimum competency. A facility outcome of these reviews. In-service
must not use any individual who has training must comply with the require-
worked less than 4 months as a nurse ments of § 483.95(g).

aide in that facility unless the indi- (e) Nursing facilities: Waiver of require-
vidual— ment to provide licensed nurses on a 24-
78
hour basis. To the extent that a facility (ii) The facility has one full-time reg-
is unable to meet the requirements of istered nurse who is regularly on duty
paragraphs (a)(2) and (b)(1) of this sec- at the facility 40 hours a week; and
tion, a State may waive such require- (iii) The facility either—
ments with respect to the facility if— (A) Has only patients whose physi-
(1) The facility demonstrates to the cians have indicated (through physi-
satisfaction of the State that the facil- cians’ orders or admission notes) that
ity has been unable, despite diligent ef- they do not require the services of a
forts (including offering wages at the registered nurse or a physician for a 48-
community prevailing rate for nursing hours period, or
facilities), to recruit appropriate per- (B) Has made arrangements for a reg-
sonnel; istered nurse or a physician to spend
(2) The State determines that a waiv- time at the facility, as determined nec-
er of the requirement will not endanger essary by the physician, to provide nec-
the health or safety of individuals essary skilled nursing services on days
staying in the facility; when the regular full-time registered
(3) The State finds that, for any peri- nurse is not on duty;
ods in which licensed nursing services (iv) The Secretary provides notice of
are not available, a registered nurse or the waiver to the Office of the State
a physician is obligated to respond im- Long-Term Care Ombudsman (estab-
mediately to telephone calls from the lished under section 712 of the Older
facility; Americans Act of 1965) and the protec-
(4) A waiver granted under the condition and advocacy system in the State
tions listed in paragraph (c) of this sec- for individuals with developmental dis-
tion is subject to annual State review; abilities or mental disorders; and
(5) In granting or renewing a waiver, (v) The facility that is granted such a
a facility may be required by the State waiver notifies residents of the facility
to use other qualified, licensed per- and their resident representatives of
sonnel; the waiver.
(6) The State agency granting a waiv- (2) A waiver of the registered nurse
er of such requirements provides notice requirement under paragraph (d)(1) of
of the waiver to the Office of the State this section is subject to annual re-
Long-Term Care Ombudsman (estab- newal by the Secretary.
lished under section 712 of the Older (g) Nurse staffing information—(1) Data
Americans Act of 1965) and the protec- requirements. The facility must post the
tion and advocacy system in the State following information on a daily basis:
for individuals with a mental disorder (i) Facility name.
who are eligible for such services as (ii) The current date.
provided by the protection and advo- (iii) The total number and the actual
cacy agency; and hours worked by the following cat-
(7) The nursing facility that is grant- egories of licensed and unlicensed nurs-
ed such a waiver by a State notifies ing staff directly responsible for resi-
residents of the facility and their resident care per shift:
dent representatives of the waiver. (A) Registered nurses.
(f) SNFs: Waiver of the requirement to (B) Licensed practical nurses or li-
provide services of a registered nurse for censed vocational nurses (as defined
more than 40 hours a week. (1) The Sec- under State law).
retary may waive the requirement that (C) Certified nurse aides.
a SNF provide the services of a reg- (iv) Resident census.
istered nurse for more than 40 hours a (2) Posting requirements. (i) The facil-
week, including a director of nursing ity must post the nurse staffing data
specified in paragraph (b) of this sec- specified in paragraph (e)(1) of this sec-
tion, if the Secretary finds that— tion on a daily basis at the beginning
(i) The facility is located in a rural of each shift.
area and the supply of skilled nursing (ii) Data must be posted as follows:
facility services in the area is not suffi- (A) Clear and readable format.
cient to meet the needs of individuals (B) In a prominent place readily ac-
residing in the area; cessible to residents and visitors.
79
§ 483.40 42 CFR Ch. IV (10–1–17 Edition)
(3) Public access to posted nurse staff- (1) A resident who displays or is diag-
ing data. The facility must, upon oral nosed with mental disorder or psycho-
or written request, make nurse staffing social adjustment difficulty, or who
data available to the public for review has a history of trauma and/or post-
at a cost not to exceed the community traumatic stress disorder, receives ap-
standard. propriate treatment and services to
(4) Facility data retention requirements. correct the assessed problem or to at-
The facility must maintain the posted tain the highest practicable mental
daily nurse staffing data for a min- and psychosocial well-being;
imum of 18 months, or as required by (2) A resident whose assessment did
State law, whichever is greater. not reveal or who does not have a diag-
nosis of a mental or psychosocial ad-
[56 FR 48873, Sept. 26, 1991, as amended at 57
FR 43925, Sept. 23, 1992; 70 FR 62073, Oct. 28,
justment difficulty or a documented
2005. Redesignated and amended at 81 FR history of trauma and/or post-trau-
68861, Oct. 4, 2016] matic stress disorder does not display a
pattern of decreased social interaction
§ 483.40 Behavioral health services. and/or increased withdrawn, angry, or
Each resident must receive and the depressive behaviors, unless the resi-
facility must provide the necessary be- dent’s clinical condition demonstrates
havioral health care and services to at- that development of such a pattern was
tain or maintain the highest prac- unavoidable; and
ticable physical, mental, and psycho- (3) A resident who displays or is diag-
social well-being, in accordance with nosed with dementia, receives the ap-
the comprehensive assessment and plan propriate treatment and services to at-
of care. Behavioral health encompasses tain or maintain his or her highest
a resident’s whole emotional and men- practicable physical, mental, and psy-
tal well-being, which includes, but is chosocial well-being.
not limited to, the prevention and (c) If rehabilitative services such as
treatment of mental and substance use but not limited to physical therapy,
disorders. speech-language pathology, occupa-
(a) The facility must have sufficient tional therapy, and rehabilitative serv-
staff who provide direct services to ices for mental disorders and intellec-
tual disability, are required in the resi-
residents with the appropriate com-
dent’s comprehensive plan of care, the
petencies and skills sets to provide
facility must—
nursing and related services to assure
(1) Provide the required services, in-
resident safety and attain or maintain
cluding specialized rehabilitation serv-
the highest practicable physical, men-
ices as required in § 483.65; or
tal and psychosocial well-being of each
(2) Obtain the required services from
resident, as determined by resident as-
an outside resource (in accordance with
sessments and individual plans of care
§ 483.70(g) of this part) from a Medicare
and considering the number, acuity
and/or Medicaid provider of specialized
and diagnoses of the facility’s resident
rehabilitative services.
population in accordance with
(d) The facility must provide medi-
§ 483.70(e). These competencies and
cally-related social services to attain
skills sets include, but are not limited
or maintain the highest practicable
to, knowledge of and appropriate train-
physical, mental and psychosocial
ing and supervision for:
well-being of each resident.
(1) Caring for residents with mental
and psychosocial disorders, as well as [81 FR 68862, Oct. 4, 2016]
residents with a history of trauma and/
or post-traumatic stress disorder, that § 483.45 Pharmacy services.
have been identified in the facility as- The facility must provide routine and
sessment conducted pursuant to emergency drugs and biologicals to its
§ 483.70(e), and residents, or obtain them under an
(2) Implementing non-pharma- agreement described in § 483.70(g). The
cological interventions. facility may permit unlicensed per-
(b) Based on the comprehensive as- sonnel to administer drugs if State law
sessment of a resident, the facility permits, but only under the general su-
must ensure that— pervision of a licensed nurse.
80
(a) Procedures. A facility must pro- tion has been taken to address it. If
vide pharmaceutical services (includ- there is to be no change in the medica-
ing procedures that assure the accurate tion, the attending physician should
acquiring, receiving, dispensing, and document his or her rationale in the
administering of all drugs and resident’s medical record.
biologicals) to meet the needs of each (5) The facility must develop and
resident. maintain policies and procedures for
(b) Service consultation. The facility the monthly drug regimen review that
must employ or obtain the services of a include, but are not limited to, time
licensed pharmacist who— frames for the different steps in the
(1) Provides consultation on all as- process and steps the pharmacist must
pects of the provision of pharmacy take when he or she identifies an irreg-
services in the facility; ularity that requires urgent action to
(2) Establishes a system of records of protect the resident.
receipt and disposition of all controlled (d) Unnecessary drugs—General. Each
drugs in sufficient detail to enable an resident’s drug regimen must be free
accurate reconciliation; and from unnecessary drugs. An unneces-
(3) Determines that drug records are sary drug is any drug when used—
in order and that an account of all con- (1) In excessive dose (including dupli-
trolled drugs is maintained and peri- cate drug therapy); or
odically reconciled. (2) For excessive duration; or
(c) Drug regimen review. (1) The drug (3) Without adequate monitoring; or
regimen of each resident must be re-
(4) Without adequate indications for
viewed at least once a month by a li-
its use; or
censed pharmacist.
(5) In the presence of adverse con-
(2) This review must include a review
sequences which indicate the dose
of the resident’s medical chart.
should be reduced or discontinued; or
(3) A psychotropic drug is any drug
that affects brain activities associated (6) Any combinations of the reasons
with mental processes and behavior. stated in paragraphs (d)(1) through (5)
These drugs include, but are not lim- of this section.
ited to, drugs in the following cat- (e) Psychotropic drugs. Based on a
egories: comprehensive assessment of a resi-
(i) Anti-psychotic; dent, the facility must ensure that—
(ii) Anti-depressant; (1) Residents who have not used psy-
(iii) Anti-anxiety; and chotropic drugs are not given these
(iv) Hypnotic. drugs unless the medication is nec-
(4) The pharmacist must report any essary to treat a specific condition as
irregularities to the attending physi- diagnosed and documented in the clin-
cian and the facility’s medical director ical record;
and director of nursing, and these re- (2) Residents who use psychotropic
ports must be acted upon. drugs receive gradual dose reductions,
(i) Irregularities include, but are not and behavioral interventions, unless
limited to, any drug that meets the cri- clinically contraindicated, in an effort
teria set forth in paragraph (d) of this to discontinue these drugs;
section for an unnecessary drug. (3) Residents do not receive psycho-
(ii) Any irregularities noted by the tropic drugs pursuant to a PRN order
pharmacist during this review must be unless that medication is necessary to
documented on a separate, written re- treat a diagnosed specific condition
port that is sent to the attending phy- that is documented in the clinical
sician and the facility’s medical direc- record; and
tor and director of nursing and lists, at (4) PRN orders for psychotropic drugs
a minimum, the resident’s name, the are limited to 14 days. Except as pro-
relevant drug, and the irregularity the vided in § 483.45(e)(5), if the attending
pharmacist identified. physician or prescribing practitioner
(iii) The attending physician must believes that it is appropriate for the
document in the resident’s medical PRN order to be extended beyond 14

record that the identified irregularity days, he or she should document their
has been reviewed and what, if any, ac- rationale in the resident’s medical
81
§ 483.50 42 CFR Ch. IV (10–1–17 Edition)
record and indicate the duration for the applicable requirements for labora-
the PRN order. tories specified in part 493 of this chap-
(5) PRN orders for anti-psychotic ter.
drugs are limited to 14 days and cannot (iii) If the laboratory chooses to refer
be renewed unless the attending physi- specimens for testing to another lab-
cian or prescribing practitioner evalu- oratory, the referral laboratory must
ates the resident for the appropriate- be certified in the appropriate special-
ness of that medication. ties and subspecialties of services in
(f) Medication errors. The facility accordance with the requirements of
must ensure that its— part 493 of this chapter.
(1) Medication error rates are not 5 (iv) If the facility does not provide
percent or greater; and laboratory services on site, it must
(2) Residents are free of any signifi- have an agreement to obtain these
cant medication errors. services from a laboratory that meets
(g) Labeling of drugs and biologicals. the applicable requirements of part 493
Drugs and biologicals used in the facil- of this chapter.
ity must be labeled in accordance with (2) The facility must:
currently accepted professional prin- (i) Provide or obtain laboratory serv-
ciples, and include the appropriate ac- ices only when ordered by a physician;
cessory and cautionary instructions, physician assistant; nurse practitioner
and the expiration date when applica- or clinical nurse specialist in accord-
ble. ance with State law, including scope of
(h) Storage of drugs and biologicals. (1) practice laws.
In accordance with State and Federal (ii) Promptly notify the ordering
laws, the facility must store all drugs physician, physician assistant, nurse
and biologicals in locked compart- practitioner, or clinical nurse spe-
ments under proper temperature con- cialist of laboratory results that fall
trols, and permit only authorized per- outside of clinical reference ranges in
sonnel to have access to the keys. accordance with facility policies and
(2) The facility must provide sepa- procedures for notification of a practi-
rately locked, permanently affixed tioner or per the ordering physician’s
compartments for storage of controlled orders.
drugs listed in Schedule II of the Com- (iii) Assist the resident in making
prehensive Drug Abuse Prevention and transportation arrangements to and
Control Act of 1976 and other drugs from the source of service, if the resi-
subject to abuse, except when the facil- dent needs assistance; and
ity uses single unit package drug dis- (iv) File in the resident’s clinical
tribution systems in which the quan- record laboratory reports that are
tity stored is minimal and a missing dated and contain the name and ad-
dose can be readily detected. dress of the testing laboratory.
[56 FR 48875, Sept. 26, 1991, as amended at 57 (b) Radiology and other diagnostic serv-
FR 43925, Sept. 23, 1992. Redesignated and ices. (1) The facility must provide or ob-
amended at 81 FR 68861, 68863, Oct. 4, 2016; 82 tain radiology and other diagnostic
FR 32259, July 13, 2017] services to meet the needs of its resi-
dents. The facility is responsible for
§ 483.50 Laboratory, radiology, and the quality and timeliness of the serv-
other diagnostic services. ices.
(a) Laboratory services. (1) The facility (i) If the facility provides its own di-
must provide or obtain laboratory serv- agnostic services, the services must
ices to meet the needs of its residents. meet the applicable conditions of par-
The facility is responsible for the qual- ticipation for hospitals contained in
ity and timeliness of the services. § 482.26 of this subchapter.
(i) If the facility provides its own lab- (ii) If the facility does not provide its
oratory services, the services must own diagnostic services, it must have
meet the applicable requirements for an agreement to obtain these services
laboratories specified in part 493 of this from a provider or supplier that is ap-
chapter. proved to provide these services under

(ii) If the facility provides blood bank Medicare.
and transfusion services, it must meet (2) The facility must:
82
(i) Provide or obtain radiology and while awaiting dental services and the
other diagnostic services only when or- extenuating circumstances that led to
dered by a physician; physician assist- the delay.
ant; nurse practitioner or clinical (b) Nursing facilities. The facility (1)
nurse specialist in accordance with Must provide or obtain from an outside
State law, including scope of practice resource, in accordance with § 483.70(g),
laws. the following dental services to meet
(ii) Promptly notify the ordering the needs of each resident:
physician, physician assistant, nurse (i) Routine dental services (to the ex-
practitioner, or clinical nurse spe- tent covered under the State plan); and
cialist of results that fall outside of (ii) Emergency dental services;
clinical reference ranges in accordance (2) Must, if necessary or if requested,
with facility policies and procedures assist the resident—
for notification of a practitioner or per (i) In making appointments; and
the ordering physician’s orders. (ii) By arranging for transportation
(iii) Assist the resident in making to and from the dental services loca-
transportation arrangements to and tions;
from the source of service, if the resi- (3) Must promptly, within 3 days,
dent needs assistance; and refer residents with lost or damaged
(iv) File in the resident’s clinical dentures for dental services. If a refer-
record signed and dated reports of x- ral does not occur within 3 days, the fa-
ray and other diagnostic services. cility must provide documentation of
what they did to ensure the resident
32259, July 13, 2017]
could still eat and drink adequately
while awaiting dental services and the
§ 483.55 Dental services. extenuating circumstances that led to
the delay;
The facility must assist residents in
(4) Must have a policy identifying
obtaining routine and 24-hour emer-
those circumstances when the loss or
gency dental care.
damage of dentures is the facility’s re-
(a) Skilled nursing facilities. A facility
sponsibility and may not charge a resi-
(1) Must provide or obtain from an out-
dent for the loss or damage of dentures
side resource, in accordance with
determined in accordance with facility
§ 483.70(g), routine and emergency den-
policy to be the facility’s responsi-
tal services to meet the needs of each
bility; and
resident;
(5) Must assist residents who are eli-
(2) May charge a Medicare resident
gible and wish to participate to apply
an additional amount for routine and
for reimbursement of dental services as
emergency dental services;
(3) Must have a policy identifying an incurred medical expense under the
those circumstances when the loss or State plan.
damage of dentures is the facility’s re- [56 FR 48875, Sept. 26, 1991, as amended at 81
sponsibility and may not charge a resi- FR 68864, Oct. 4, 2016]
dent for the loss or damage of dentures
determined in accordance with facility § 483.60 Food and nutrition services.
policy to be the facility’s responsi- The facility must provide each resi-
bility; dent with a nourishing, palatable, well-
(4) Must if necessary or if requested, balanced diet that meets his or her
assist the resident— daily nutritional and special dietary
(i) In making appointments; and needs, taking into consideration the
(ii) By arranging for transportation preferences of each resident.
to and from the dental services loca- (a) Staffing. The facility must employ
tion; and sufficient staff with the appropriate
(5) Must promptly, within 3 days, competencies and skills sets to carry
refer residents with lost or damaged out the functions of the food and nutri-
dentures for dental services. If a refer- tion service, taking into consideration
ral does not occur within 3 days, the fa- resident assessments, individual plans
cility must provide documentation of of care and the number, acuity and di-
what they did to ensure the resident agnoses of the facility’s resident popu-
could still eat and drink adequately lation in accordance with the facility
83
§ 483.60 42 CFR Ch. IV (10–1–17 Edition)
assessment required at § 483.70(e). This cludes food service or restaurant man-

includes: agement, from an accredited institu-
(1) A qualified dietitian or other tion of higher learning; and
clinically qualified nutrition profes- (ii) In States that have established
sional either full-time, part-time, or on standards for food service managers or
a consultant basis. A qualified dieti- dietary managers, meets State require-
tian or other clinically qualified nutri- ments for food service managers or die-
tion professional is one who— tary managers, and
(i) Holds a bachelor’s or higher de- (iii) Receives frequently scheduled
gree granted by a regionally accredited consultations from a qualified dietitian
college or university in the United or other clinically qualified nutrition
States (or an equivalent foreign de- professional.
gree) with completion of the academic (3) Support staff. The facility must
requirements of a program in nutrition provide sufficient support personnel to
or dietetics accredited by an appro- safely and effectively carry out the
priate national accreditation organiza- functions of the food and nutrition
tion recognized for this purpose. service.
(ii) Has completed at least 900 hours (b) A member of the Food and Nutri-
of supervised dietetics practice under tion Services staff must participate on
the supervision of a registered dietitian the interdisciplinary team as required
or nutrition professional. in § 483.21(b)(2)(ii).
(iii) Is licensed or certified as a dieti- (c) Menus and nutritional adequacy.
tian or nutrition professional by the Menus must—
State in which the services are per- (1) Meet the nutritional needs of resi-
formed. In a state that does not pro- dents in accordance with established
vide for licensure or certification, the national guidelines.;
individual will be deemed to have met (2) Be prepared in advance;
this requirement if he or she is recog- (3) Be followed;
nized as a ‘‘registered dietitian’’ by the
(4) Reflect, based on a facility’s rea-
Commission on Dietetic Registration
sonable efforts, the religious, cultural,
or its successor organization, or meets
and ethnic needs of the resident popu-
the requirements of paragraphs (a)(1)(i)
lation, as well as input received from
and (ii) of this section.
residents and resident groups;
(iv) For dietitians hired or con-
(5) Be updated periodically;
tracted with prior to November 28, 2016,
meets these requirements no later than (6) Be reviewed by the facility’s dieti-
5 years after November 28, 2016 or as re- tian or other clinically qualified nutri-
quired by state law. tion professional for nutritional ade-
(2) If a qualified dietitian or other quacy; and
clinically qualified nutrition profes- (7) Nothing in this paragraph should
sional is not employed full-time, the be construed to limit the resident’s
facility must designate a person to right to make personal dietary choices.
serve as the director of food and nutri- (d) Food and drink. Each resident re-
tion services who— ceives and the facility provides—
(i) For designations prior to Novem- (1) Food prepared by methods that
ber 28, 2016, meets the following re- conserve nutritive value, flavor, and
quirements no later than 5 years after appearance;
November 28, 2016, or no later than 1 (2) Food and drink that is palatable,
year after November 28, 2016 for des- attractive, and at a safe and appetizing
ignations after November 28, 2016, is: temperature;
(A) A certified dietary manager; or (3) Food prepared in a form designed
(B) A certified food service manager, to meet individual needs;
or (4) Food that accommodates resident
(C) Has similar national certification allergies, intolerances, and preferences;
for food service management and safe- (5) Appealing options of similar nu-
ty from a national certifying body; or tritive value to residents who choose
(D) Has an associate’s or higher de- not to eat food that is initially served
gree in food service management or in or who request a different meal choice;
hospitality, if the course study in- and
84
(6) Drinks, including water and other (3) Resident selection criteria. (i) A fa-
liquids consistent with resident needs cility must ensure that a feeding as-
and preferences and sufficient to main- sistant provides dining assistance only
tain resident hydration. for residents who have no complicated
(e) Therapeutic diets. (1) Therapeutic feeding problems.
diets must be prescribed by the attend- (ii) Complicated feeding problems in-
ing physician. clude, but are not limited to, difficulty
(2) The attending physician may dele- swallowing, recurrent lung aspirations,
gate to a registered or licensed dieti- and tube or parenteral/IV feedings.
tian the task of prescribing a resident’s (iii) The facility must base resident
diet, including a therapeutic diet, to selection on the interdisciplinary
the extent allowed by State law. team’s assessment and the resident’s
(f) Frequency of meals. (1) Each resi- latest assessment and plan of care. Ap-
dent must receive and the facility must propriateness for this program should
provide at least three meals daily, at be reflected in the comprehensive care
regular times comparable to normal plan.
mealtimes in the community or in ac- (i) Food safety requirements. The facil-
cordance with resident needs, pref- ity must—
erences, requests, and plan of care. (1) Procure food from sources ap-
(2) There must be no more than 14 proved or considered satisfactory by
hours between a substantial evening federal, state, or local authorities;
meal and breakfast the following day, (i) This may include food items ob-
except when a nourishing snack is tained directly from local producers,
served at bedtime, up to 16 hours may subject to applicable State and local
elapse between a substantial evening laws or regulations.
meal and breakfast the following day if (ii) This provision does not prohibit
a resident group agrees to this meal or prevent facilities from using
span. produce grown in facility gardens, sub-
(3) Suitable, nourishing alternative ject to compliance with applicable safe
meals and snacks must be provided to growing and food-handling practices.
residents who want to eat at non-tradi- (iii) This provision does not preclude
tional times or outside of scheduled residents from consuming foods not
meal service times, consistent with the procured by the facility.
resident plan of care. (2) Store, prepare, distribute, and
(g) Assistive devices. The facility must serve food in accordance with profes-
provide special eating equipment and sional standards for food service safety.
utensils for residents who need them (3) Have a policy regarding use and
and appropriate assistance to ensure storage of foods brought to residents
that the resident can use the assistive by family and other visitors to ensure
devices when consuming meals and safe and sanitary storage, handling,
snacks. and consumption, and
(h) Paid feeding assistants—(1) State- (4) Dispose of garbage and refuse
approved training course. A facility may properly.
use a paid feeding assistant, as defined [81 FR 68864, Oct. 4, 2016]
in § 488.301 of this chapter, if—
(i) The feeding assistant has success- § 483.65 Specialized rehabilitative
fully completed a State-approved services.
training course that meets the require- (a) Provision of services. If specialized
ments of § 483.160 before feeding resi- rehabilitative services such as but not
dents; and limited to physical therapy, speech-
(ii) The use of feeding assistants is language pathology, occupational ther-
consistent with State law. apy, respiratory therapy, and rehabili-
(2) Supervision. (i) A feeding assistant tative services for a mental disorder
must work under the supervision of a and intellectual disability or services
registered nurse (RN) or licensed prac- of a lesser intensity as set forth at
tical nurse (LPN). § 483.120(c), are required in the resi-
(ii) In an emergency, a feeding assist- dent’s comprehensive plan of care, the

ant must call a supervisory nurse for facility must—
help. (1) Provide the required services; or
85
§ 483.70 42 CFR Ch. IV (10–1–17 Edition)
(2) In accordance with § 483.70(g), ob- (d) Governing body. (1) The facility
tain the required services from an out- must have a governing body, or des-
side resource that is a provider of spe- ignated persons functioning as a gov-
cialized rehabilitative services and is erning body, that is legally responsible
not excluded from participating in any for establishing and implementing poli-
federal or state health care programs cies regarding the management and op-
pursuant to section 1128 and 1156 of the eration of the facility; and
Act. (2) The governing body appoints the
(b) Qualifications. Specialized reha- administrator who is—
bilitative services must be provided (i) Licensed by the State, where li-
under the written order of a physician censing is required;
by qualified personnel. (ii) Responsible for management of
the facility; and
FR 43925, Sept. 23, 1992. Redesignated and (iii) Reports to and is accountable to
amended at 81 FR 68861, 68865, Oct. 4, 2016] the governing body.
(3) The governing body is responsible
§ 483.70 Administration. and accountable for the QAPI program,
A facility must be administered in a in accordance with § 483.75(f).
manner that enables it to use its re- (e) Facility assessment. The facility
sources effectively and efficiently to must conduct and document a facility-
attain or maintain the highest prac- wide assessment to determine what re-
ticable physical, mental, and psycho- sources are necessary to care for its
social well-being of each resident. residents competently during both day-
(a) Licensure. A facility must be li- to-day operations and emergencies.
censed under applicable State and local The facility must review and update
law. that assessment, as necessary, and at
least annually. The facility must also
(b) Compliance with Federal, State, and
review and update this assessment
local laws and professional standards.
whenever there is, or the facility plans
The facility must operate and provide
for, any change that would require a
services in compliance with all applica-
substantial modification to any part of
ble Federal, State, and local laws, reg-
this assessment. The facility assess-
ulations, and codes, and with accepted
ment must address or include:
professional standards and principles
that apply to professionals providing (1) The facility’s resident population,
services in such a facility. including, but not limited to,
(c) Relationship to other HHS regula- (i) Both the number of residents and
tions. In addition to compliance with the facility’s resident capacity;
the regulations set forth in this sub- (ii) The care required by the resident
part, facilities are obliged to meet the population considering the types of dis-
applicable provisions of other HHS reg- eases, conditions, physical and cog-
ulations, including but not limited to nitive disabilities, overall acuity, and
those pertaining to nondiscrimination other pertinent facts that are present
on the basis of race, color, or national within that population;
origin (45 CFR part 80); nondiscrimina- (iii) The staff competencies that are
tion on the basis of disability (45 CFR necessary to provide the level and
part 84); nondiscrimination on the types of care needed for the resident
basis of age (45 CFR part 91); non- population;
discrimination on the basis of race, (iv) The physical environment, equip-
color, national origin, sex, age, or dis- ment, services, and other physical
ability (45 CFR part 92); protection of plant considerations that are necessary
human subjects of research (45 CFR to care for this population; and
part 46); and fraud and abuse (42 CFR (v) Any ethnic, cultural, or religious
part 455) and protection of individually factors that may potentially affect the
identifiable health information (45 CFR care provided by the facility, includ-
parts 160 and 164). Violations of such ing, but not limited to, activities and
other provisions may result in a find- food and nutrition services.

ing of non-compliance with this para- (2) The facility’s resources, including
graph. but not limited to,
86
(i) All buildings and/or other physical (h) Medical director. (1) The facility
structures and vehicles; must designate a physician to serve as
(ii) Equipment (medical and nonmedical director.
medical); (2) The medical director is respon-
(iii) Services provided, such as phys- sible for—
ical therapy, pharmacy, and specific (i) Implementation of resident care
rehabilitation therapies; policies; and
(iv) All personnel, including man- (ii) The coordination of medical care
agers, staff (both employees and those in the facility.
who provide services under contract), (i) Medical records. (1) In accordance
and volunteers, as well as their edu- with accepted professional standards
cation and/or training and any com- and practices, the facility must main-
petencies related to resident care; tain medical records on each resident
(v) Contracts, memorandums of un- that are—
derstanding, or other agreements with (i) Complete;
third parties to provide services or (ii) Accurately documented;
equipment to the facility during both (iii) Readily accessible; and
normal operations and emergencies; (iv) Systematically organized.
and (2) The facility must keep confiden-
(vi) Health information technology tial all information contained in the
resources, such as systems for elec- resident’s records, regardless of the
tronically managing patient records form or storage method of the records,
and electronically sharing information except when release is—
with other organizations. (i) To the individual, or their resi-
(3) A facility-based and community- dent representative where permitted by
based risk assessment, utilizing an all- applicable law;
hazards approach. (ii) Required by law;
(f) Staff qualifications. (1) The facility (iii) For treatment, payment, or
must employ on a full-time, part-time health care operations, as permitted by
or consultant basis those professionals and in compliance with 45 CFR 164.506;
necessary to carry out the provisions (iv) For public health activities, re-
of these requirements. porting of abuse, neglect, or domestic
(2) Professional staff must be li- violence, health oversight activities,
censed, certified, or registered in ac- judicial and administrative pro-
cordance with applicable State laws. ceedings, law enforcement purposes,
(g) Use of outside resources. (1) If the organ donation purposes, research pur-
facility does not employ a qualified poses, or to coroners, medical exam-
professional person to furnish a specific iners, funeral directors, and to avert a
service to be provided by the facility, serious threat to health or safety as
the facility must have that service fur- permitted by and in compliance with 45
nished to residents by a person or agen- CFR 164.512.
cy outside the facility under an ar- (3) The facility must safeguard med-
rangement described in section 1861(w) ical record information against loss,
of the Act or (with respect to services destruction, or unauthorized use;
furnished to NF residents and dental (4) Medical records must be retained
services furnished to SNF residents) an for—
agreement described in paragraph (g)(2) (i) The period of time required by
of this section. State law; or
(2) Arrangements as described in sec- (ii) Five years from the date of dis-
tion 1861(w) of the Act or agreements charge when there is no requirement in
pertaining to services furnished by out- State law; or
side resources must specify in writing (iii) For a minor, 3 years after a resi-
that the facility assumes responsibility dent reaches legal age under State law.
for— (5) The medical record must con-
(i) Obtaining services that meet pro- tain—
fessional standards and principles that (i) Sufficient information to identify
apply to professionals providing serv- the resident;

ices in such a facility; and (ii) A record of the resident’s assess-
(ii) The timeliness of the services. ments;
87
§ 483.70 42 CFR Ch. IV (10–1–17 Edition)
(iii) The comprehensive plan of care (i) Persons with an ownership or con-
and services provided; trol interest, as defined in §§ 420.201 and
(iv) The results of any preadmission 455.101 of this chapter;
screening and resident review evalua- (ii) The officers, directors, agents, or
tions and determinations conducted by managing employees;
the State; (iii) The corporation, association, or
(v) Physician’s, nurse’s, and other li- other company responsible for the
censed professional’s progress notes; management of the facility; or
and (iv) The facility’s administrator or
(vi) Laboratory, radiology and other director of nursing.
diagnostic services reports as required (3) The notice specified in paragraph
under § 483.50. (k)(2) of this section must include the
(j) Transfer agreement. (1) In accord- identity of each new individual or com-
ance with section 1861(l) of the Act, the pany.
facility (other than a nursing facility (l) Facility closure-Administrator. Any
which is located in a State on an In- individual who is the administrator of
dian reservation) must have in effect a the facility must:
written transfer agreement with one or (1) Submit to the State Survey Agen-
more hospitals approved for participa- cy, the State LTC ombudsman, resi-
tion under the Medicare and Medicaid dents of the facility, and the legal rep-
programs that reasonably assures resentatives of such residents or other
that— responsible parties, written notifica-
(i) Residents will be transferred from tion of an impending closure:
the facility to the hospital, and en- (i) At least 60 days prior to the date
sured of timely admission to the hos- of closure; or
pital when transfer is medically appro- (ii) In the case of a facility where the
priate as determined by the attending Secretary or a State terminates the fa-
physician or, in an emergency situa- cility’s participation in the Medicare
tion, by another practitioner in accord- and/or Medicaid programs, not later
ance with facility policy and consistent than the date that the Secretary deter-
with state law; and mines appropriate;
(ii) Medical and other information (2) Ensure that the facility does not
needed for care and treatment of resi- admit any new residents on or after the
dents and, when the transferring facil- date on which such written notifica-
ity deems it appropriate, for deter- tion is submitted; and
mining whether such residents can re- (3) Include in the notice the plan,
ceive appropriate services or receive that has been approved by the State,
services in a less restrictive setting for the transfer and adequate reloca-
than either the facility or the hospital, tion of the residents of the facility by
or reintegrated into the community, a date that would be specified by the
will be exchanged between the pro- State prior to closure, including assur-
viders, including but not limited to the ances that the residents would be
information required under transferred to the most appropriate fa-
§ 483.15(c)(2)(iii). cility or other setting in terms of qual-
(2) The facility is considered to have ity, services, and location, taking into
a transfer agreement in effect if the fa- consideration the needs, choice, and
cility has attempted in good faith to best interests of each resident.
enter into an agreement with a hos- (m) Facility closure. The facility must
pital sufficiently close to the facility have in place policies and procedures
to make transfer feasible. to ensure that the administrator’s du-
(k) Disclosure of ownership. (1) The fa- ties and responsibilities involve pro-
cility must comply with the disclosure viding the appropriate notices in the
requirements of §§ 420.206 and 455.104 of event of a facility closure, as required
this chapter. at paragraph (l) of this section.
(2) The facility must provide written (n) Binding arbitration agreements. (1)
notice to the State agency responsible A facility must not enter into a pre-
for licensing the facility at the time of dispute agreement for binding arbitra-
change, if a change occurs in— tion with any resident or resident’s
88
representative nor require that a resi- (o) Hospice services. (1) A long-term
dent sign an arbitration agreement as care (LTC) facility may do either of
a condition of admission to the LTC fa- the following:
cility. (i) Arrange for the provision of hos-
(2) If, after a dispute between the fa- pice services through an agreement
cility and a resident arises, and a facil- with one or more Medicare-certified
ity chooses to ask a resident or his or hospices.
her representative to enter into an (ii) Not arrange for the provision of
agreement for binding arbitration, the hospice services at the facility through
facility must comply with all of the re- an agreement with a Medicare-certified
quirements in this section. hospice and assist the resident in
(i) The facility must ensure that: transferring to a facility that will ar-
(A) The agreement is explained to the range for the provision of hospice serv-
resident and their representative in a ices when a resident requests a trans-
form and manner that he or she under- fer.
stands, including in a language the (2) If hospice care is furnished in an
resident and their representative un- LTC facility through an agreement as
derstands, and specified in paragraph (o)(1)(i) of this
(B) The resident acknowledges that section with a hospice, the LTC facility
he or she understands the agreement. must meet the following requirements:
(ii) The agreement must: (i) Ensure that the hospice services
(A) Be entered into by the resident meet professional standards and prin-
voluntarily. ciples that apply to individuals pro-
(B) Provide for the selection of a neu- viding services in the facility, and to
tral arbitrator agreed upon by both the timeliness of the services.
parties. (ii) Have a written agreement with
(C) Provide for selection of a venue the hospice that is signed by an au-
convenient to both parties. thorized representative of the hospice
(iii) A resident’s continuing right to and an authorized representative of the
remain in the facility must not be con- LTC facility before hospice care is fur-
tingent upon the resident or the resi- nished to any resident. The written
dent’s representative signing a binding agreement must set out at least the
arbitration agreement. following:
(iv) The agreement must not contain (A) The services the hospice will pro-
any language that prohibits or discour- vide.
ages the resident or anyone else from (B) The hospice’s responsibilities for
communicating with federal, state, or determining the appropriate hospice
local officials, including but not lim- plan of care as specified in § 418.112 (d)
ited to, federal and state surveyors, of this chapter.
other federal or state health depart- (C) The services the LTC facility will
ment employees, and representatives of continue to provide, based on each resi-
the Office of the State Long-Term Care dent’s plan of care.
Ombudsman, in accordance with (D) A communication process, includ-
§ 483.10(k). ing how the communication will be
(v) The agreement may be signed by documented between the LTC facility
another individual if: and the hospice provider, to ensure
(A) Allowed by state law; that the needs of the resident are ad-
(B) All of the requirements in this dressed and met 24 hours per day.
section are met; and (E) A provision that the LTC facility
(C) That individual has no interest in immediately notifies the hospice about
the facility. the following:
(vi) When the facility and a resident (1) A significant change in the resi-
resolve a dispute with arbitration, a dent’s physical, mental, social, or emo-
copy of the signed agreement for bind- tional status.
ing arbitration and the arbitrator’s (2) Clinical complications that sug-
final decision must be retained by the gest a need to alter the plan of care.
facility for 5 years and be available for (3) A need to transfer the resident
inspection upon request by CMS or its from the facility for any condition.
designee. (4) The resident’s death.
89
§ 483.70 42 CFR Ch. IV (10–1–17 Edition)
(F) A provision stating that the hos- ordinate care to the resident provided
pice assumes responsibility for deter- by the LTC facility staff and hospice
mining the appropriate course of hos- staff. The interdisciplinary team mem-
pice care, including the determination ber must have a clinical background,
to change the level of services pro- function within their State scope of
vided. practice act, and have the ability to as-
(G) An agreement that it is the LTC sess the resident or have access to
facility’s responsibility to furnish 24- someone that has the skills and capa-
hour room and board care, meet the bilities to assess the resident. The des-
resident’s personal care and nursing ignated interdisciplinary team member
needs in coordination with the hospice is responsible for the following:
representative, and ensure that the (i) Collaborating with hospice rep-
level of care provided is appropriately resentatives and coordinating LTC fa-
based on the individual resident’s cility staff participation in the hospice
needs. care planning process for those resi-
(H) A delineation of the hospice’s re- dents receiving these services.
sponsibilities, including but not lim- (ii) Communicating with hospice rep-
ited to, providing medical direction resentatives and other healthcare pro-
and management of the patient; nurs- viders participating in the provision of
ing; counseling (including spiritual, di- care for the terminal illness, related
etary, and bereavement); social work; conditions, and other conditions, to en-
providing medical supplies, durable sure quality of care for the patient and
medical equipment, and drugs nec- family.
essary for the palliation of pain and (iii) Ensuring that the LTC facility
symptoms associated with the terminal communicates with the hospice med-
illness and related conditions; and all ical director, the patient’s attending
other hospice services that are nec- physician, and other practitioners par-
essary for the care of the resident’s ter- ticipating in the provision of care to
minal illness and related conditions. the patient as needed to coordinate the
(I) A provision that when the LTC fa- hospice care with the medical care pro-
cility personnel are responsible for the vided by other physicians.
administration of prescribed therapies, (iv) Obtaining the following informa-
including those therapies determined tion from the hospice:
appropriate by the hospice and delin- (A) The most recent hospice plan of
eated in the hospice plan of care, the care specific to each patient.
LTC facility personnel may administer
(B) Hospice election form.
the therapies where permitted by State
(C) Physician certification and recer-
law and as specified by the LTC facil-
tification of the terminal illness spe-
ity.
cific to each patient.
(J) A provision stating that the LTC
facility must report all alleged viola- (D) Names and contact information
tions involving mistreatment, neglect, for hospice personnel involved in hos-
or verbal, mental, sexual, and physical pice care of each patient.
abuse, including injuries of unknown (E) Instructions on how to access the
source, and misappropriation of patient hospice’s 24-hour on-call system.
property by hospice personnel, to the (F) Hospice medication information
hospice administrator immediately specific to each patient.
when the LTC facility becomes aware (G) Hospice physician and attending
of the alleged violation. physician (if any) orders specific to
(K) A delineation of the responsibil- each patient.
ities of the hospice and the LTC facil- (v) Ensuring that the LTC facility
ity to provide bereavement services to staff provides orientation in the poli-
LTC facility staff. cies and procedures of the facility, in-
(3) Each LTC facility arranging for cluding patient rights, appropriate
the provision of hospice care under a forms, and record keeping require-
written agreement must designate a ments, to hospice staff furnishing care
member of the facility’s interdiscipli- to LTC residents.

nary team who is responsible for work- (4) Each LTC facility providing hos-
ing with hospice representatives to co- pice care under a written agreement
90
must ensure that each resident’s writ- (iii) Information on direct care staff
ten plan of care includes both the most turnover and tenure, and on the hours
recent hospice plan of care and a de- of care provided by each category of
scription of the services furnished by staff per resident per day (including,
the LTC facility to attain or maintain but not limited to, start date, end date
the resident’s highest practicable phys- (as applicable), and hours worked for
ical, mental, and psychosocial well- each individual).
being, as required at § 483.25. (3) Distinguishing employee from agen-
(p) Social worker. Any facility with cy and contract staff. When reporting in-
more than 120 beds must employ a formation about direct care staff, the
qualified social worker on a full-time facility must specify whether the indi-
basis. A qualified social worker is: vidual is an employee of the facility, or
(1) An individual with a minimum of is engaged by the facility under con-
a bachelor’s degree in social work or a tract or through an agency.
bachelor’s degree in a human services (4) Data format. The facility must
field including, but not limited to, so- submit direct care staffing information
ciology, gerontology, special edu- in the uniform format specified by
cation, rehabilitation counseling, and CMS.
psychology; and (5) Submission schedule. The facility
(2) One year of supervised social work must submit direct care staffing infor-
experience in a health care setting mation on the schedule specified by
working directly with individuals. CMS, but no less frequently than quar-
(q) Mandatory submission of staffing terly.
information based on payroll data in a
uniform format. Long-term care facili- [56 FR 48877, Sept. 26, 1991, as amended at 56
FR 48918, Sept. 26, 1991; 57 FR 7136, Feb. 28,
ties must electronically submit to CMS
1992; 57 FR 43925, Sept. 23, 1992; 59 FR 56237,
complete and accurate direct care Nov. 10, 1994; 63 FR 26311, May 12, 1998; 68 FR
staffing information, including infor- 55539, Sept. 26, 2003; 74 FR 40363, Aug. 11, 2009;
mation for agency and contract staff, 76 FR 9511, Feb. 18, 2011; 78 FR 16805, Mar. 19,
based on payroll and other verifiable 2013; 78 FR 38605, June 27, 2013; 80 FR 46477,
and auditable data in a uniform format Aug. 4, 2015; 81 FR 64032, Sept. 16, 2016. Redes-
according to specifications established ignated and amended at 81 FR 68861, 68865,
by CMS. Oct. 4, 2016; 82 FR 32259, July 13, 2017]
(1) Direct Care Staff. Direct Care Staff
§ 483.73 Emergency preparedness.
are those individuals who, through
interpersonal contact with residents or The LTC facility must comply with
resident care management, provide all applicable Federal, State and local
care and services to allow residents to emergency preparedness requirements.
attain or maintain the highest prac- The LTC facility must establish and
ticable physical, mental, and psycho- maintain an emergency preparedness
social well-being. Direct care staff does program that meets the requirements
not include individuals whose primary of this section. The emergency pre-
duty is maintaining the physical envi- paredness program must include, but
ronment of the long term care facility not be limited to, the following ele-
(for example, housekeeping). ments:
(2) Submission requirements. The facil- (a) Emergency plan. The LTC facility
ity must electronically submit to CMS must develop and maintain an emer-
complete and accurate direct care gency preparedness plan that must be
staffing information, including the fol- reviewed, and updated at least annu-
lowing: ally. The plan must do all of the fol-
(i) The category of work for each per- lowing:
son on direct care staff (including, but (1) Be based on and include a docu-
not limited to, whether the individual mented, facility-based and community-
is a registered nurse, licensed practical based risk assessment, utilizing an all-
nurse, licensed vocational nurse, cer- hazards approach, including missing
tified nursing assistant, therapist, or residents.
other type of medical personnel as (2) Include strategies for addressing

specified by CMS); emergency events identified by the
(ii) Resident census data; and risk assessment.
91
§ 483.73 42 CFR Ch. IV (10–1–17 Edition)
(3) Address resident population, in- identification of evacuation loca-

cluding, but not limited to, persons at- tion(s); and primary and alternate
risk; the type of services the LTC facil- means of communication with external
ity has the ability to provide in an sources of assistance.
emergency; and continuity of oper- (4) A means to shelter in place for
ations, including delegations of author- residents, staff, and volunteers who re-
ity and succession plans. main in the LTC facility.
(4) Include a process for cooperation (5) A system of medical documenta-
and collaboration with local, tribal, re- tion that preserves resident informa-
gional, State, or Federal emergency tion, protects confidentiality of resi-
preparedness officials’ efforts to main- dent information, and secures and
tain an integrated response during a maintains the availability of records.
disaster or emergency situation, in- (6) The use of volunteers in an emer-
cluding documentation of the LTC fa- gency or other emergency staffing
cility’s efforts to contact such officials strategies, including the process and
and, when applicable, of its participa- role for integration of State or Feder-
tion in collaborative and cooperative ally designated health care profes-
planning efforts. sionals to address surge needs during
(b) Policies and procedures. The LTC an emergency.
facility must develop and implement (7) The development of arrangements
emergency preparedness policies and with other LTC facilities and other
procedures, based on the emergency providers to receive residents in the
plan set forth in paragraph (a) of this event of limitations or cessation of op-
section, risk assessment at paragraph erations to maintain the continuity of
(a)(1) of this section, and the commu- services to LTC residents.
nication plan at paragraph (c) of this (8) The role of the LTC facility under
section. The policies and procedures a waiver declared by the Secretary, in
must be reviewed and updated at least accordance with section 1135 of the
annually. At a minimum, the policies Act, in the provision of care and treat-
and procedures must address the fol- ment at an alternate care site identi-
lowing: fied by emergency management offi-
(1) The provision of subsistence needs cials.
for staff and residents, whether they (c) Communication plan. The LTC fa-
evacuate or shelter in place, include, cility must develop and maintain an
but are not limited to the following: emergency preparedness communica-
(i) Food, water, medical, and pharma- tion plan that complies with Federal,
ceutical supplies. State, and local laws and must be re-
(ii) Alternate sources of energy to viewed and updated at least annually.
maintain— The communication plan must include
(A) Temperatures to protect resident all of the following:
health and safety and for the safe and (1) Names and contact information
sanitary storage of provisions; for the following:
(B) Emergency lighting; (i) Staff.
(C) Fire detection, extinguishing, and (ii) Entities providing services under
alarm systems; and arrangement.
(D) Sewage and waste disposal. (iii) Residents’ physicians.
(2) A system to track the location of (iv) Other LTC facilities.
on-duty staff and sheltered residents in (v) Volunteers.
the LTC facility’s care during and after (2) Contact information for the fol-
an emergency. If on-duty staff and lowing:
sheltered residents are relocated dur- (i) Federal, State, tribal, regional, or
ing the emergency, the LTC facility local emergency preparedness staff.
must document the specific name and (ii) The State Licensing and Certifi-
location of the receiving facility or cation Agency.
other location. (iii) The Office of the State Long-
(3) Safe evacuation from the LTC fa- Term Care Ombudsman.
cility, which includes consideration of (iv) Other sources of assistance.

care and treatment needs of evacuees; (3) Primary and alternate means for
staff responsibilities; transportation; communicating with the following:
92
(i) LTC facility’s staff. gency plan at least annually, including

(ii) Federal, State, tribal, regional, unannounced staff drills using the
or local emergency management agen- emergency procedures. The LTC facil-
cies. ity must do the following:
(4) A method for sharing information (i) Participate in a full-scale exercise
and medical documentation for resi- that is community-based or when a
dents under the LTC facility’s care, as community-based exercise is not acces-
necessary, with other health care pro- sible, an individual, facility-based. If
viders to maintain the continuity of the LTC facility experiences an actual
care. natural or man-made emergency that
(5) A means, in the event of an evacu- requires activation of the emergency
ation, to release resident information plan, the LTC facility is exempt from
as permitted under 45 CFR engaging in a community-based or in-
164.510(b)(1)(ii). dividual, facility-based full-scale exer-
(6) A means of providing information cise for 1 year following the onset of
about the general condition and loca- the actual event.
tion of residents under the facility’s (ii) Conduct an additional exercise
care as permitted under 45 CFR that may include, but is not limited to
164.510(b)(4). the following:
(7) A means of providing information (A) A second full-scale exercise that
about the LTC facility’s occupancy, is community-based or individual, fa-
needs, and its ability to provide assist- cility-based.
ance, to the authority having jurisdic- (B) A tabletop exercise that includes
tion or the Incident Command Center, a group discussion led by a facilitator,
or designee. using a narrated, clinically-relevant
(8) A method for sharing information emergency scenario, and a set of prob-
from the emergency plan that the fa- lem statements, directed messages, or
cility has determined is appropriate prepared questions designed to chal-
with residents and their families or lenge an emergency plan.
representatives. (iii) Analyze the LTC facility’s re-
(d) Training and testing. The LTC fa- sponse to and maintain documentation
cility must develop and maintain an of all drills, tabletop exercises, and
emergency preparedness training and emergency events, and revise the LTC
testing program that is based on the facility’s emergency plan, as needed.
emergency plan set forth in paragraph (e) Emergency and standby power sys-
(a) of this section, risk assessment at tems. The LTC facility must implement
paragraph (a)(1) of this section, policies emergency and standby power systems
and procedures at paragraph (b) of this based on the emergency plan set forth
section, and the communication plan in paragraph (a) of this section.
at paragraph (c) of this section. The (1) Emergency generator location. The
training and testing program must be generator must be located in accord-
reviewed and updated at least annu- ance with the location requirements
ally. found in the Health Care Facilities
(1) Training program. The LTC facility Code (NFPA 99 and Tentative Interim
must do all of the following: Amendments TIA 12–2, TIA 12–3, TIA
(i) Initial training in emergency pre- 12–4, TIA 12–5, and TIA 12–6), Life Safe-
paredness policies and procedures to all ty Code (NFPA 101 and Tentative In-
new and existing staff, individuals pro- terim Amendments TIA 12–1, TIA 12–2,
viding services under arrangement, and TIA 12–3, and TIA 12–4), and NFPA 110,
volunteers, consistent with their ex- when a new structure is built or when
pected roles. an existing structure or building is ren-
(ii) Provide emergency preparedness ovated.
training at least annually. (2) Emergency generator inspection and
(iii) Maintain documentation of the testing. The LTC facility must imple-
training. ment the emergency power system in-
(iv) Demonstrate staff knowledge of spection, testing, and maintenance re-
emergency procedures. quirements found in the Health Care

(2) Testing. The LTC facility must Facilities Code, NFPA 110, and Life
conduct exercises to test the emer- Safety Code.
93
§ 483.75 42 CFR Ch. IV (10–1–17 Edition)
(3) Emergency generator fuel. LTC fa- Director of the Office of the Federal
cilities that maintain an onsite fuel Register in accordance with 5 U.S.C.
source to power emergency generators 552(a) and 1 CFR part 51. You may ob-
must have a plan for how it will keep tain the material from the sources list-
emergency power systems operational ed below. You may inspect a copy at
during the emergency, unless it evacu- the CMS Information Resource Center,
ates. 7500 Security Boulevard, Baltimore,
(f) Integrated healthcare systems. If a MD or at the National Archives and
LTC facility is part of a healthcare sys- Records Administration (NARA). For
tem consisting of multiple separately information on the availability of this
certified healthcare facilities that material at NARA, call 202–741–6030, or
elects to have a unified and integrated go to: http://www.archives.gov/
emergency preparedness program, the federallregister/
LTC facility may choose to participate codeloflfederallregulations/
in the healthcare system’s coordinated ibrllocations.html. If any changes in
emergency preparedness program. If this edition of the Code are incor-
elected, the unified and integrated porated by reference, CMS will publish
emergency preparedness program must a document in the FEDERAL REGISTER
do all of the following: to announce the changes.
(1) Demonstrate that each separately (1) National Fire Protection Associa-
certified facility within the system action, 1 Batterymarch Park, Quincy,
tively participated in the development MA 02169, www.nfpa.org, 1.617.770.3000.
of the unified and integrated emer- (i) NFPA 99, Health Care Facilities
gency preparedness program. Code 2012 edition, issued August 11,
(2) Be developed and maintained in a 2011.
manner that takes into account each (ii) Technical interim amendment
separately certified facility’s unique (TIA) 12–2 to NFPA 99, issued August
circumstances, patient populations, 11, 2011.
and services offered. (iii) TIA 12–3 to NFPA 99, issued Au-
(3) Demonstrate that each separately gust 9, 2012.
certified facility is capable of actively (iv) TIA 12–4 to NFPA 99, issued
using the unified and integrated emer- March 7, 2013.
gency preparedness program and is in (v) TIA 12–5 to NFPA 99, issued Au-
compliance with the program. gust 1, 2013.
(4) Include a unified and integrated (vi) TIA 12–6 to NFPA 99, issued
emergency plan that meets the require- March 3, 2014.
ments of paragraphs (a)(2), (3), and (4) (vii) NFPA 101, Life Safety Code, 2012
of this section. The unified and inte- edition, issued August 11, 2011.
grated emergency plan must also be (viii) TIA 12–1 to NFPA 101, issued
based on and include— August 11, 2011.
(i) A documented community-based (ix) TIA 12–2 to NFPA 101, issued Oc-
risk assessment, utilizing an all-haz- tober 30, 2012.
ards approach. (x) TIA 12–3 to NFPA 101, issued Oc-
(ii) A documented individual facility- tober 22, 2013.
based risk assessment for each sepa- (xi) TIA 12–4 to NFPA 101, issued Oc-
rately certified facility within the tober 22, 2013.
health system, utilizing an all-hazards (xii) NFPA 110, Standard for Emer-
approach. gency and Standby Power Systems,
(5) Include integrated policies and 2010 edition, including TIAs to chapter
procedures that meet the requirements 7, issued August 6, 2009.
set forth in paragraph (b) of this sec- (2) [Reserved]
tion, a coordinated communication [81 FR 64030, Sept. 16, 2016; 81 FR 80594, Nov.
plan and training and testing programs 16, 2016]
that meet the requirements of para-
graphs (c) and (d) of this section, re- § 483.75 Quality assurance and per-
spectively. formance improvement.
(g) The standards incorporated by (a) Quality assurance and performance

reference in this section are approved improvement (QAPI) program. Each LTC
for incorporation by reference by the facility, including a facility that is
94
part of a multiunit chain, must de- cies and procedures must include, at a
velop, implement, and maintain an ef- minimum, the following:
fective, comprehensive, data-driven (1) Facility maintenance of effective
QAPI program that focuses on indica- systems to obtain and use of feedback
tors of the outcomes of care and qual- and input from direct care staff, other
ity of life. The facility must— staff, residents, and resident represent-
(1) Maintain documentation and dem- atives, including how such information
onstrate evidence of its ongoing QAPI will be used to identify problems that
program that meets the requirements are high risk, high volume, or problem-
of this section. This may include but is prone, and opportunities for improve-
not limited to systems and reports ment.
demonstrating systematic identifica- (2) Facility maintenance of effective
tion, reporting, investigation, analysis, systems to identify, collect, and use
and prevention of adverse events; and data and information from all depart-
documentation demonstrating the de- ments, including but not limited to the
velopment, implementation, and eval- facility assessment required at
uation of corrective actions or per- § 483.70(e) and including how such infor-
formance improvement activities; mation will be used to develop and
(2) Present its QAPI plan to the State monitor performance indicators.
Survey Agency no later than 1 year (3) Facility development, monitoring,
after the promulgation of this regula- and evaluation of performance indica-
tion; tors, including the methodology and
(3) Present its QAPI plan to a State frequency for such development, moni-
Survey Agency or Federal surveyor at toring, and evaluation.
each annual recertification survey and (4) Facility adverse event moni-
upon request during any other survey toring, including the methods by which
and to CMS upon request; and the facility will systematically iden-
tify, report, track, investigate, analyze
(4) Present documentation and evi-
and use data and information relating
dence of its ongoing QAPI program’s
to adverse events in the facility, in-
implementation and the facility’s com-
cluding how the facility will use the
pliance with requirements to a State
data to develop activities to prevent
Survey Agency, Federal surveyor or
adverse events.
CMS upon request.
(d) Program systematic analysis and
(b) Program design and scope. A facil- systemic action. (1) The facility must
ity must design its QAPI program to be take actions aimed at performance im-
ongoing, comprehensive, and to address provement and, after implementing
the full range of care and services pro- those actions, measure its success, and
vided by the facility. It must: track performance to ensure that im-
(1) Address all systems of care and provements are realized and sustained.
management practices; (2) The facility will develop and im-
(2) Include clinical care, quality of plement policies addressing:
life, and resident choice; (i) How they will use a systematic ap-
(3) Utilize the best available evidence proach to determine underlying causes
to define and measure indicators of of problems impacting larger systems;
quality and facility goals that reflect (ii) How they will develop corrective
processes of care and facility oper- actions that will be designed to effect
ations that have been shown to be pre- change at the systems level to prevent
dictive of desired outcomes for resi- quality of care, quality of life, or safe-
dents of a SNF or NF. ty problems ; and
(4) Reflect the complexities, unique (iii) How the facility will monitor the
care, and services that the facility pro- effectiveness of its performance im-
vides. provement activities to ensure that im-
(c) Program feedback, data systems and provements are sustained.
monitoring. A facility must establish (e) Program activities. (1) The facility
and implement written policies and must set priorities for its performance
procedures for feedback, data collec- improvement activities that focus on

tions systems, and monitoring, includ- high-risk, high-volume, or problem-
ing adverse event monitoring. The poli- prone areas; consider the incidence,
95
§ 483.80 42 CFR Ch. IV (10–1–17 Edition)
prevalence, and severity of problems in (g) Quality assessment and assurance.

those areas; and affect health out- (1) A facility must maintain a quality
comes, resident safety, resident auton- assessment and assurance committee
omy, resident choice, and quality of consisting at a minimum of:
care. (i) The director of nursing services;
(2) Performance improvement activi- (ii) The Medical Director or his or
ties must track medical errors and ad- her designee;
verse resident events, analyze their (iii) At least three other members of
causes, and implement preventive ac- the facility’s staff, at least one of who
tions and mechanisms that include must be the administrator, owner, a
feedback and learning throughout the board member or other individual in a
facility. leadership role; and
(iv) The infection preventionist.
(3) As a part of their performance im-
(2) The quality assessment and assur-
provement activities, the facility must
ance committee reports to the facili-
conduct distinct performance improve-
ty’s governing body, or designated per-
ment projects. The number and fre-
son(s) functioning as a governing body
quency of improvement projects con- regarding its activities, including im-
ducted by the facility must reflect the plementation of the QAPI program re-
scope and complexity of the facility’s quired under paragraphs (a) through (e)
services and available resources, as re- of this section. The committee must:
flected in the facility assessment re- (i) Meet at least quarterly and as
quired at § 483.70(e). Improvement needed to coordinate and evaluate ac-
projects must include at least annually tivities under the QAPI program, such
a project that focuses on high risk or as identifying issues with respect to
problem-prone areas identified through which quality assessment and assur-
the data collection and analysis de- ance activities, including performance
scribed in paragraphs (c) and (d) of this improvement projects required under
section. the QAPI program, are necessary; and
(f) Governance and leadership. The (ii) Develop and implement appro-
governing body and/or executive lead- priate plans of action to correct identi-
ership (or organized group or individual fied quality deficiencies; and
who assumes full legal authority and (iii) Regularly review and analyze
responsibility for operation of the fa- data, including data collected under
cility) is responsible and accountable the QAPI program and data resulting
for ensuring that— from drug regimen reviews, and act on
(1) An ongoing QAPI program is de- available data to make improvements.
fined, implemented, and maintained (h) Disclosure of information. A State
and addresses identified priorities. or the Secretary may not require dis-
(2) The QAPI program is sustained closure of the records of such com-
during transitions in leadership and mittee except in so far as such disclo-
staffing; sure is related to the compliance of
(3) The QAPI program is adequately such committee with the requirements
resourced, including ensuring staff of this section.
time, equipment, and technical train- (i) Sanctions. Good faith attempts by
ing as needed; the committee to identify and correct
(4) The QAPI program identifies and quality deficiencies will not be used as
prioritizes problems and opportunities a basis for sanctions.
that reflect organizational process, [81 FR 68867, Oct. 4, 2016, as amended at 82 FR
functions, and services provided to 32259, July 13, 2017]
resident based on performance indi-
cator data, and resident and staff § 483.80 Infection control.
input, and other information. The facility must establish and main-
(5) Corrective actions address gaps in tain an infection prevention and con-
systems, and are evaluated for effec- trol program designed to provide a
tiveness; and safe, sanitary, and comfortable envi-
(6) Clear expectations are set around ronment and to help prevent the devel-
safety, quality, rights, choice, and re- opment and transmission of commu-
spect. nicable diseases and infections.
96
(a) Infection prevention and control sible for the facility’s IPCP. The IP
program. The facility must establish an must:
infection prevention and control pro- (1) Have primary professional train-
gram (IPCP) that must include, at a ing in nursing, medical technology,
minimum, the following elements: microbiology, epidemiology, or other
(1) A system for preventing, identi- related field;
fying, reporting, investigating, and (2) Be qualified by education, train-
controlling infections and commu- ing, experience or certification;
nicable diseases for all residents, staff, (3) Work at least part-time at the fa-
volunteers, visitors, and other individ- cility; and
uals providing services under a con-
(4) Have completed specialized train-
tractual arrangement based upon the
ing in infection prevention and control.
facility assessment conducted accord-
ing to § 483.70(e) and following accepted (c) IP participation on quality assess-
national standards; ment and assurance committee. The indi-
(2) Written standards, policies, and vidual designated as the IP, or at least
procedures for the program, which one of the individuals if there is more
must include, but are not limited to: than one IP, must be a member of the
(i) A system of surveillance designed facility’s quality assessment and assur-
to identify possible communicable dis- ance committee and report to the com-
eases or infections before they can mittee on the IPCP on a regular basis.
spread to other persons in the facility; (d) Influenza and pneumococcal immu-
(ii) When and to whom possible inci- nizations—(1) Influenza. The facility
dents of communicable disease or in- must develop policies and procedures
fections should be reported; to ensure that—
(iii) Standard and transmission-based (i) Before offering the influenza im-
precautions to be followed to prevent munization, each resident or the resi-
spread of infections; dent’s representative receives edu-
(iv) When and how isolation should cation regarding the benefits and po-
be used for a resident; including but tential side effects of the immuniza-
not limited to: tion;
(A) The type and duration of the iso- (ii) Each resident is offered an influ-
lation, depending upon the infectious enza immunization October 1 through
agent or organism involved, and March 31 annually, unless the immuni-
(B) A requirement that the isolation zation is medically contraindicated or
should be the least restrictive possible the resident has already been immu-
for the resident under the cir- nized during this time period;
cumstances. (iii) The resident or the resident’s
(v) The circumstances under which representative has the opportunity to
the facility must prohibit employees refuse immunization; and
with a communicable disease or in-
(iv) The resident’s medical record in-
fected skin lesions from direct contact
cludes documentation that indicates,
with residents or their food, if direct
at a minimum, the following:
contact will transmit the disease; and
(vi) The hand hygiene procedures to (A) That the resident or resident’s
be followed by staff involved in direct representative was provided education
resident contact. regarding the benefits and potential
(3) An antibiotic stewardship pro- side effects of influenza immunization;
gram that includes antibiotic use pro- and
tocols and a system to monitor anti- (B) That the resident either received
biotic use. the influenza immunization or did not
(4) A system for recording incidents receive the influenza immunization due
identified under the facility’s IPCP and to medical contraindications or re-
the corrective actions taken by the fa- fusal.
cility. (2) Pneumococcal disease. The facility
(b) Infection preventionist. The facility must develop policies and procedures
must designate one or more indi- to ensure that—

vidual(s) as the infection (i) Before offering the pneumococcal
preventionist(s) (IPs) who are respon- immunization, each resident or the
97
§ 483.85 42 CFR Ch. IV (10–1–17 Edition)
resident’s representative receives edu- Operating organization means the in-

cation regarding the benefits and po- dividual(s) or entity that operates a fa-
tential side effects of the immuniza- cility.
tion; (b) General rule. Beginning November
(ii) Each resident is offered a pneu- 28, 2019, the operating organization for
mococcal immunization, unless the im- each facility must have in operation a
munization is medically contra- compliance and ethics program (as de-
indicated or the resident has already fined in paragraph (a) of this section)
been immunized; that meets the requirements of this
(iii) The resident or the resident’s section.
representative has the opportunity to (c) Required components for all facili-
refuse immunization; and ties. The operating organization for
(iv) The resident’s medical record in- each facility must develop, implement,
cludes documentation that indicates, and maintain an effective compliance
at a minimum, the following: and ethics program that contains, at a
(A) That the resident or resident’s minimum, the following components:
representative was provided education (1) Established written compliance
regarding the benefits and potential and ethics standards, policies, and pro-
side effects of pneumococcal immuniza- cedures to follow that are reasonably
tion; and capable of reducing the prospect of
(B) That the resident either received criminal, civil, and administrative vio-
the pneumococcal immunization or did lations under the Act and promote
not receive the pneumococcal immuni- quality of care, which include, but are
zation due to medical contraindication not limited to, the designation of an
or refusal. appropriate compliance and ethics pro-
(e) Linens. Personnel must handle, gram contact to which individuals may
store, process, and transport linens so report suspected violations, as well as
as to prevent the spread of infection. an alternate method of reporting sus-
(f) Annual review. The facility will pected violations anonymously without
conduct an annual review of its IPCP fear of retribution; and disciplinary
and update their program, as nec- standards that set out the con-
essary. sequences for committing violations
for the operating organization’s entire
[81 FR 68868, Oct. 4, 2016] staff; individuals providing services
under a contractual arrangement; and
§ 483.85 Compliance and ethics pro- volunteers, consistent with the volun-
gram. teers’ expected roles.
(a) Definitions. For purposes of this (2) Assignment of specific individuals
section, the following definitions within the high-level personnel of the
apply: operating organization with the overall
Compliance and ethics program means, responsibility to oversee compliance
with respect to a facility, a program of with the operating organization’s com-
the operating organization that— pliance and ethics program’s standards,
(1) Has been reasonably designed, im- policies, and procedures, such as, but
plemented, and enforced so that it is not limited to, the chief executive offi-
likely to be effective in preventing and cer (CEO), members of the board of di-
detecting criminal, civil, and adminis- rectors, or directors of major divisions
trative violations under the Act and in in the operating organization.
promoting quality of care; and (3) Sufficient resources and authority
(2) Includes, at a minimum, the re- to the specific individuals designated
quired components specified in para- in paragraph (c)(2) of this section to
graph (c) of this section. reasonably assure compliance with
High-level personnel means indi- such standards, policies, and proce-
vidual(s) who have substantial control dures.
over the operating organization or who (4) Due care not to delegate substan-
have a substantial role in the making tial discretionary authority to individ-

of policy within the operating organi- uals who the operating organization
zation. knew, or should have known through
98
the exercise of due diligence, had a pro- administrative violations under the
pensity to engage in criminal, civil, Act.
and administrative violations under (d) Additional required components for
the Social Security Act. operating organizations with five or more
(5) The facility takes steps to effec- facilities. In addition to all of the other
tively communicate the standards, requirements in paragraphs (a), (b), (c),
policies, and procedures in the oper- and (e) of this section, operating orga-
ating organization’s compliance and nizations that operate five or more fa-
ethics program to the operating orga- cilities must also include, at a min-
nization’s entire staff; individuals pro- imum, the following components in
viding services under a contractual ar- their compliance and ethics program:
rangement; and volunteers, consistent (1) A mandatory annual training pro-
with the volunteers’ expected roles. Re- gram on the operating organization’s
quirements include, but are not limited compliance and ethics program that
meets the requirements set forth in
to, mandatory participation in training
§ 483.95(f).
as set forth at § 483.95(f) or orientation
(2) A designated compliance officer
programs, or disseminating informa-
for whom the operating organization’s
tion that explains in a practical man-
compliance and ethics program is a
ner what is required under the pro- major responsibility. This individual
gram. must report directly to the operating
(6) The facility takes reasonable organization’s governing body and not
steps to achieve compliance with the be subordinate to the general counsel,
program’s standards, policies, and pro- chief financial officer or chief oper-
cedures. Such steps include, but are ating officer.
not limited to, utilizing monitoring (3) Designated compliance liaisons lo-
and auditing systems reasonably de- cated at each of the operating organi-
signed to detect criminal, civil, and ad- zation’s facilities.
ministrative violations under the Act (e) Annual review. The operating or-
by any of the operating organization’s ganization for each facility must re-
staff, individuals providing services view its compliance and ethics pro-
under a contractual arrangement, or gram annually and revise its program
volunteers, having in place and publi- as needed to reflect changes in all ap-
cizing a reporting system whereby any plicable laws or regulations and within
of these individuals could report viola- the operating organization and its fa-
tions by others anonymously within cilities to improve its performance in
the operating organization without deterring, reducing, and detecting vio-
fear of retribution, and having a proc- lations under the Act and in promoting
ess for ensuring the integrity of any re- quality of care.
ported data.
(7) Consistent enforcement of the op- 32259, July 13, 2017]
erating organization’s standards, poli-
cies, and procedures through appro- § 483.90 Physical environment.
priate disciplinary mechanisms, in- The facility must be designed, con-
cluding, as appropriate, discipline of structed, equipped, and maintained to
individuals responsible for the failure protect the health and safety of resi-
to detect and report a violation to the dents, personnel and the public.
compliance and ethics program contact (a) Life safety from fire. (1) Except as
identified in the operating organiza- otherwise provided in this section—
tion’s compliance and ethics program. (i) The LTC facility must meet the
(8) After a violation is detected, the applicable provisions and must proceed
operating organization must ensure in accordance with the Life Safety
that all reasonable steps identified in Code (NFPA 101 and Tentative Interim
its program are taken to respond ap- Amendments TIA 12–1, TIA 12–2, TIA
propriately to the violation and to pre- 12–3, and TIA 12–4.)
vent further similar violations, includ- (ii) Notwithstanding paragraph
ing any necessary modification to the (a)(1)(i) of this section, corridor doors
operating organization’s program to and doors to rooms containing flam-
prevent and detect criminal, civil, and mable or combustible materials must
99
§ 483.90 42 CFR Ch. IV (10–1–17 Edition)
be provided with positive latching NFPA 13 1999 edition of the Standard

hardware. Roller latches are prohibited for the Installation of Sprinkler Systems,
on such doors. issued July 22, 1999 for incorporation by
(2) In consideration of a rec- reference in accordance with 5 U.S.C.
ommendation by the State survey 552(a) and 1 CFR part 51. A copy of the
agency or Accrediting Organization or Code is available for inspection at the
at the discretion of the Secretary, may CMS Information Resource Center, 7500
waive, for periods deemed appropriate, Security Boulevard, Baltimore, MD or
specific provisions of the Life Safety at the National Archives and Records
Code, which would result in unreason- Administration (NARA). For informa-
able hardship upon a long-term care fa- tion on the availability of this mate-
cility, but only if the waiver will not rial at NARA, call 202–741–6030, or go
adversely affect the health and safety to: http://www.archives.gov/
of the patients. federallregister/
(3) The provisions of the Life safety codeloflfederallregulations/
Code do not apply in a State where ibrllocations.html. Copies may be ob-
CMS finds, in accordance with applica- tained from the National Fire Protec-
ble provisions of sections tion Association, 1 Batterymarch Park,
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of Quincy, MA 02269.
the Act, that a fire and safety code im- (ii) Test, inspect, and maintain an
posed by State law adequately protects approved, supervised automatic sprin-
patients, residents and personnel in kler system in accordance with the 1998
long term care facilities.
edition of NFPA 25, Standard for the In-
(4) A long-term care facility may in-
spection, Testing, and Maintenance of
stall alcohol-based hand rub dispensers
Water-Based Fire Protection Systems, as
in its facility if the dispensers are in-
incorporated by reference. The Direc-
stalled in a manner that adequately
tor of the Office of the Federal Register
protects against inappropriate access.
has approved the NFPA 25, Standard for
(5) A long term care facility must:
the Inspection, Testing, and Maintenance
(i) Install, at least, battery-operated
of Water-Based Fire Protection Systems,
single station smoke alarms in accord-
1998 edition, issued January 16, 1998 for
ance with the manufacturer’s rec-
ommendations in resident sleeping incorporation by reference in accord-
rooms and common areas. ance with 5 U.S.C. 552(a) and 1 CFR
(ii) Have a program for inspection, part 51. A copy of the Code is available
testing, maintenance, and battery re- for inspection at the CMS Information
placement that conforms to the manu- Resource Center, 7500 Security Boule-
facturer’s recommendations and that vard, Baltimore, MD or at the National
verifies correct operation of the smoke Archives and Records Administration
alarms. (NARA). For information on the avail-
(iii) Exception: ability of this material at NARA, call
(A) The facility has system-based 202–741–6030, or go to: http://
smoke detectors in patient rooms and www.archives.gov/federallregister/
common areas that are installed, test- codeloflfederallregulations/
ed, and maintained in accordance with ibrllocations.html. Copies may be ob-
NFPA 72, National Fire Alarm Code, for tained from the National Fire Protec-
system-based smoke detectors; or tion Association, 1 Batterymarch Park,
(B) The facility is fully sprinklered Quincy, MA 02269.
in accordance with NFPA 13, Standard (iii) Subject to approval by CMS, a
for the Installation of Sprinkler Systems. long term care facility may be granted
(6) A long term care facility must: an extension of the sprinkler installa-
(i) Install an approved, supervised tion deadline for a time period not to
automatic sprinkler system in accord- exceed 2 years from August 13, 2013, if
ance with the 1999 edition of NFPA 13, the facility meets all of the following
Standard for the Installation of Sprinkler conditions:
Systems, as incorporated by reference, (A) It is in the process of replacing
throughout the building by August 13, its current building, or undergoing

2013. The Director of the Office of the major modifications to improve the
Federal Register has approved the living conditions for residents in all
100
unsprinklered living areas that re- (ii) Establish a fire watch until the
quires the movement of corridor, room, system is back in service.
partition, or structural walls or sup- (b) Standard: Building safety. Except
ports, in addition to the installation of as otherwise provided in this section,
a sprinkler system; or, has had its the LTC facility must meet the appli-
planned sprinkler installation so im- cable provisions and must proceed in
paired by a disaster or emergency, as accordance with the Health Care Fa-
indicated by a declaration under sec- cilities Code (NFPA 99 and Tentative
tion 319 of the Public Health Service Interim Amendments TIA 12–2, TIA 12–
Act, that CMS finds it would be im- 3, TIA 12–4, TIA 12–5 and TIA 12–6).
practical to meet the sprinkler instal-
(1) Chapters 7, 8, 12, and 13 of the
lation due date.
(B) It demonstrates that it has made adopted Health Care Facilities Code do
the necessary financial commitments not apply to a LTC facility.
to complete the building replacement (2) If application of the Health Care
or modification; or pursuant to a de- Facilities Code required under para-
clared disaster or emergency, CMS graph (b) of this section would result in
finds it impractical to make reasonable unreasonable hardship for the LTC fa-
and necessary financial commitments. cility, CMS may waive specific provi-
(C) Before applying for the deadline sions of the Health Care Facilities
extension, it has submitted plans to Code, but only if the waiver does not
State and local authorities that are adversely affect the health and safety
necessary for approval of the replace- of residents.
ment building or major modification (c) Emergency power. (1) An emer-
that includes the required sprinkler in- gency electrical power system must
stallation, and has received approval of supply power adequate at least for
the plans from State and local authori- lighting all entrances and exits; equip-
ties. ment to maintain the fire detection,
(D) It agrees to complete interim alarm, and extinguishing systems; and
steps to improve fire safety, as deter- life support systems in the event the
mined by CMS.
normal electrical supply is interrupted.
(iv) An extension granted under para-
graph (a)(8)(iii) of this section may be (2) When life support systems are
renewed once, for an additional period used, the facility must provide emer-
not to exceed 1 year, if the following gency electrical power with an emer-
conditions are met: gency generator (as defined in NFPA
(A) CMS finds that extenuating cir- 99, Health Care Facilities) that is lo-
cumstances beyond the control of the cated on the premises.
facility will prevent full compliance (d) Space and equipment. The facility
with the provisions in paragraph must—
(a)(8)(i) of this section by the end of the (1) Provide sufficient space and
first waiver period. equipment in dining, health services,
(B) All other conditions of paragraph recreation, and program areas to en-
(a)(8)(iii) of this section are met. able staff to provide residents with
(7) Buildings must have an outside needed services as required by these
window or outside door in every sleep- standards and as identified in each
ing room, and for any building con- resident’s plan of care; and
structed after July 5, 2016 the sill (2) Maintain all essential mechanical,
height must not exceed 36 inches above electrical, and patient care equipment
the floor. Windows in atrium walls are in safe operating condition.
considered outside windows for the pur-
(e) Resident rooms. Resident rooms
poses of this requirement.
(8) When a sprinkler system is shut must be designed and equipped for ade-
down for more than 10 hours, the LTC quate nursing care, comfort, and pri-
facility must: vacy of residents.
(i) Evacuate the building or portion (1) Bedrooms must—
of the building affected by the system (i) Accommodate no more than four
outage until the system is back in residents. For facilities that receive
service, or
101
§ 483.90 42 CFR Ch. IV (10–1–17 Edition)
approval of construction or reconstruc- residents to call for staff assistance

tion plans by State and local authori- through a communication system
ties or are newly certified after Novem- which relays the call directly to a staff
ber 28, 2016, bedrooms must accommo- member or to a centralized staff work
date no more than two residents. area from—
(ii) Measure at least 80 square feet (1) Each resident’s bedside; and
per resident in multiple resident bed- (2) Toilet and bathing facilities.
rooms, and at least 100 square feet in (h) Dining and resident activities. The
single resident rooms; facility must provide one or more
(iii) Have direct access to an exit cor- rooms designated for resident dining
ridor; and activities. These rooms must—
(iv) Be designed or equipped to assure (1) Be well lighted;
full visual privacy for each resident; (2) Be well ventilated;
(v) In facilities initially certified
(3) Be adequately furnished; and
after March 31, 1992, except in private
(4) Have sufficient space to accommo-
rooms, each bed must have ceiling sus-
date all activities.
pended curtains, which extend around
the bed to provide total visual privacy (i) Other environmental conditions. The
in combination with adjacent walls and facility must provide a safe, func-
curtains; tional, sanitary, and comfortable envi-
(vi) Have at least one window to the ronment for the residents, staff and the
outside; and public. The facility must—
(vii) Have a floor at or above grade (1) Establish procedures to ensure
level. that water is available to essential
(2) The facility must provide each areas when there is a loss of normal
resident with— water supply;
(i) A separate bed of proper size and (2) Have adequate outside ventilation
height for the safety and convenience by means of windows, or mechanical
of the resident; ventilation, or a combination of the
(ii) A clean, comfortable mattress; two;
(iii) Bedding appropriate to the (3) Equip corridors with firmly se-
weather and climate; and cured handrails on each side; and
(iv) Functional furniture appropriate (4) Maintain an effective pest control
to the resident’s needs, and individual program so that the facility is free of
closet space in the resident’s bedroom pests and rodents.
with clothes racks and shelves acces- (5) Establish policies, in accordance
sible to the resident. with applicable Federal, State, and
(3) CMS, or in the case of a nursing local laws and regulations, regarding
facility the survey agency, may permit smoking, smoking areas, and smoking
variations in requirements specified in safety that also take into account non-
paragraphs (d)(1) (i) and (ii) of this sec- smoking residents.
tion relating to rooms in individual (j) The standards incorporated by ref-
cases when the facility demonstrates in erence in this section are approved for
writing that the variations— incorporation by reference by the Di-
(i) Are in accordance with the special rector of the Office of the Federal Reg-
needs of the residents; and ister in accordance with 5 U.S.C. 552(a)
(ii) Will not adversely affect resi- and 1 CFR part 51. You may inspect a
dents’ health and safety. copy at the CMS Information Resource
(f) Bathroom facilities. Each resident Center, 7500 Security Boulevard, Balti-
room must be equipped with or located more, MD or at the National Archives
near toilet and bathing facilities. For and Records Administration (NARA).
facilities that receive approval of con- For information on the availability of
struction from State and local authori- this material at NARA, call 202–741–
ties or are newly certified after Novem- 6030, or go to: http://www.archives.gov/
ber 28, 2016, each resident room must federallregister/
have its own bathroom equipped with codeloflfederallregulations/
at least a commode and sink. ibrllocations.html. If any changes in

(g) Resident call system. The facility this edition of the Code are incor-
must be adequately equipped to allow porated by reference, CMS will publish
102
a document in the FEDERAL REGISTER sibilities of a facility to properly care

to announce the changes. for its residents as set forth at § 483.10,
(1) National Fire Protection Associa- respectively.
tion, 1 Batterymarch Park, Quincy, (c) Abuse, neglect, and exploitation. In
MA 02169, www.nfpa.org, 1.617.770.3000. addition to the freedom from abuse, ne-
(i) NFPA 99, Standards for Health glect, and exploitation requirements in
Care Facilities Code of the National § 483.12, facilities must also provide
Fire Protection Association 99, 2012 training to their staff that at a min-
edition, issued August 11, 2011. imum educates staff on—
(ii) TIA 12–2 to NFPA 99, issued Au- (1) Activities that constitute abuse,
gust 11, 2011. neglect, exploitation, and misappro-
(iii) TIA 12–3 to NFPA 99, issued Au- priation of resident property as set
gust 9, 2012. forth at § 483.12.
(iv) TIA 12–4 to NFPA 99, issued (2) Procedures for reporting incidents
March 7, 2013. of abuse, neglect, exploitation, or the
(v) TIA 12–5 to NFPA 99, issued Au-
misappropriation of resident property.
gust 1, 2013.
(vi) TIA 12–6 to NFPA 99, issued (3) Dementia management and resi-
March 3, 2014. dent abuse prevention.
(vii) NFPA 101, Life Safety Code, 2012 (d) Quality assurance and performance
edition, issued August 11, 2011; improvement. A facility must include as
(viii) TIA 12–1 to NFPA 101, issued part of its QAPI program mandatory
August 11, 2011. training that outlines and informs staff
(ix) TIA 12–2 to NFPA 101, issued Oc- of the elements and goals of the facili-
tober 30, 2012. ty’s QAPI program as set forth at
(x) TIA 12–3 to NFPA 101, issued Oc- § 483.75.
tober 22, 2013. (e) Infection control. A facility must
(xi) TIA 12–4 to NFPA 101, issued Oc- include as part of its infection preven-
tober 22, 2013. tion and control program mandatory
(2) [Reserved] training that includes the written
standards, policies, and procedures for
FR 43925, Sept. 23, 1992; 68 FR 1386, Jan. 10, the program as described at
2003; 69 FR 49268, Aug. 11, 2004; 70 FR 15238, § 483.80(a)(2).
Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 73 FR (f) Compliance and ethics. The oper-
47091, Aug. 13, 2008; 79 FR 27155, May 12, 2014; ating organization for each facility
81 FR 26899, May 4, 2016; 81 FR 42548, June 30, must include as part of its compliance
2016. Redesignated and amended at 81 FR and ethics program, as set forth at
68861, 68870, Oct. 4, 2016; 82 FR 32259, July 13,
2017]
§ 483.85—
(1) An effective way to communicate
§ 483.95 Training requirements. that program’s standards, policies, and
A facility must develop, implement, procedures through a training program
and maintain an effective training pro- or in another practical manner which
gram for all new and existing staff; in- explains the requirements under the
dividuals providing services under a program.
contractual arrangement; and volun- (2) Annual training if the operating
teers, consistent with their expected organization operates five or more fa-
roles. A facility must determine the cilities.
amount and types of training necessary (g) Required in-service training for
based on a facility assessment as speci- nurse aides. In-service training must—
fied at § 483.70(e). Training topics must (1) Be sufficient to ensure the con-
include but are not limited to— tinuing competence of nurse aides, but
(a) Communication. A facility must in- must be no less than 12 hours per year.
clude effective communications as (2) Include dementia management
mandatory training for direct care training and resident abuse prevention
staff. training.
(b) Resident’s rights and facility respon- (3) Address areas of weakness as de-
sibilities. A facility must ensure that termined in nurse aides’ performance

staff members are educated on the reviews and facility assessment at
rights of the resident and the respon- § 483.70(e) and may address the special
103
§ 483.100 42 CFR Ch. IV (10–1–17 Edition)
needs of residents as determined by the Incorporation of the 1987 edition of

facility staff. the Diagnostic and Statistical Manual
(4) For nurse aides providing services of Mental Disorders, 3rd edition, was
to individuals with cognitive impair- approved by the Director of the Federal
ments, also address the care of the cog- Register in accordance with 5 U.S.C.
nitively impaired. 552(a) and 1 CFR part 51 that govern
(h) Required training of feeding assist- the use of incorporation by reference. 1
ants. A facility must not use any indi- This mental disorder is—
vidual working in the facility as a paid (A) A schizophrenic, mood, paranoid,
feeding assistant unless that individual panic or other severe anxiety disorder;
has successfully completed a State-ap- somatoform disorder; personality dis-
proved training program for feeding as- order; other psychotic disorder; or an-
sistants, as specified in § 483.160. other mental disorder that may lead to
(i) Behavioral health. A facility must a chronic disability; but
provide behavioral health training con- (B) Not a primary diagnosis of de-
sistent with the requirements at mentia, including Alzheimer’s disease
§ 483.40 and as determined by the facil- or a related disorder, or a non-primary
ity assessment at § 483.70(e). diagnosis of dementia unless the pri-
mary diagnosis is a major mental dis-
[81 FR 68870, Oct. 4, 2016]
order as defined in paragraph
(b)(1)(i)(A) of this section.
Subpart C—Preadmission Screen- (ii) Level of impairment. The disorder
ing and Annual Review of results in functional limitations in
Mentally Ill and Mentally Re- major life activities within the past 3
tarded Individuals to 6 months that would be appropriate
for the individual’s developmental
SOURCE: 57 FR 56506, Nov. 30, 1992, unless stage. An individual typically has at
otherwise noted. least one of the following characteris-
tics on a continuing or intermittent
§ 483.100 Basis. basis:
The requirements of §§ 483.100 (A) Interpersonal functioning. The in-
through 483.138 governing the State’s dividual has serious difficulty inter-
responsibility for preadmission screen- acting appropriately and commu-
ing and annual resident review nicating effectively with other persons,
(PASARR) of individuals with mental has a possible history of altercations,
illness and intellectual disability are evictions, firing, fear of strangers,
avoidance of interpersonal relation-
based on section 1919(e)(7) of the Act.
ships and social isolation;
§ 483.102 Applicability and definitions. (B) Concentration, persistence, and
pace. The individual has serious dif-
(a) This subpart applies to the ficulty in sustaining focused attention
screening or reviewing of all individ- for a long enough period to permit the
uals with mental illness or intellectual completion of tasks commonly found
disability who apply to or reside in in work settings or in work-like struc-
Medicaid certified NFs regardless of tured activities occurring in school or
the source of payment for the NF serv-
ices, and regardless of the individual’s 1 The Diagnostic and Statistical Manual of
or resident’s known diagnoses. Mental Disorders is available for inspection
(b) Definitions. As used in this sub- at the Centers for Medicare & Medicaid Serv-
part— ices, room 132, East High Rise Building, 6325
(1) An individual is considered to Security Boulevard, Baltimore, Maryland, or
have a serious mental illness (MI) if at the National Archives and Records Ad-
the individual meets the following re- ministration (NARA). For information on
quirements on diagnosis, level of im- the availability of this material at NARA,
pairment and duration of illness: call 202–741–6030, or go to: http://
(i) Diagnosis. The individual has a codeloflfederallregulations/
major mental disorder diagnosable
ibrllocations.html. Copies may be obtained

under the Diagnostic and Statistical from the American Psychiatric Association,
Manual of Mental Disorders, 3rd edi- Division of Publications and Marketing, 1400
tion, revised in 1987. K Street, NW., Washington, DC 20005.
104
home settings, manifests difficulties in govern the use of incorporations by ref-

concentration, inability to complete erence;2 or
simple tasks within an established (ii) A related condition as defined by
time period, makes frequent errors, or § 435.1010 of this chapter.
requires assistance in the completion [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
of these tasks; and 28, 1993; 71 FR 39229, July 12, 2006]
(C) Adaptation to change. The indi-
vidual has serious difficulty in adapt- § 483.104 State plan requirement.
ing to typical changes in cir- As a condition of approval of the
cumstances associated with work, State plan, the State must operate a
school, family, or social interaction, preadmission screening and annual
manifests agitation, exacerbated signs resident review program that meets
and symptoms associated with the ill- the requirements of §§ 483.100 through
ness, or withdrawal from the situation, 438.138.
or requires intervention by the mental
health or judicial system. § 483.106 Basic rule.
(iii) Recent treatment. The treatment
(a) Requirement. The State PASARR
history indicates that the individual
program must require—(1)
has experienced at least one of the fol-
Preadmission screening of all individ-
lowing:
uals with mental illness or intellectual
(A) Psychiatric treatment more in-
disability who apply as new admissions
tensive than outpatient care more than
to Medicaid NFs on or after January 1,
once in the past 2 years (e.g., partial
1989;
hospitalization or inpatient hos-
(2) Initial review, by April 1, 1990, of
pitalization); or
all current residents with intellectual
(B) Within the last 2 years, due to the
disability or mental illness who en-
mental disorder, experienced an epi-
tered Medicaid NFs prior to January 1,
sode of significant disruption to the
1989; and
normal living situation, for which sup-
(3) At least annual review, as of April
portive services were required to main-
1, 1990, of all residents with mental ill-
tain functioning at home, or in a resi-
ness or intellectual disability, regard-
dential treatment environment, or
less of whether they were first screened
which resulted in intervention by hous-
under the preadmission screening or
ing or law enforcement officials.
annual resident review requirements.
(2) An individual is considered to
(b) Admissions, readmissions and inter-
have dementia if he or she has a pri-
facility transfers—(1) New admission. An
mary diagnosis of dementia, as de-
individual is a new admission if he or
scribed in the Diagnostic and Statis-
she is admitted to any NF for the first
tical Manual of Mental Disorders, 3rd
time or does not qualify as a readmis-
edition, revised in 1987, or a non-pri-
sion. With the exception of certain hos-
mary diagnosis of dementia unless the
pital discharges described in paragraph
primary diagnosis is a major mental
(b)(2) of this section, new admissions
disorder as defined in paragraph
are subject to preadmission screening.
(b)(1)(i)(A) of this section.
(3) An individual is considered to
2 The American Association on Intellectual
have intellectual disability (IID) if he
Disability’s Manual on Classification in In-
or she has— tellectual Disability is available for inspec-
(i) A level of retardation (mild, mod- tion at the Centers for Medicare & Medicaid
erate, severe or profound) described in Services, Room 132, East High Rise Building,
the American Association on Intellec- 6325 Security Boulevard, Baltimore, Mary-
tual Disability’s Manual on Classifica- land, or at the National Archives and
tion in Intellectual Disability (1983). Records Administration (NARA). For infor-
Incorporation by reference of the 1983 mation on the availability of this material
edition of the American Association on at NARA, call 202–741–6030, or go to: http://
Intellectual Disability’s Manual on codeloflfederallregulations/
Classification in Intellectual Disability
ibrllocations.html. Copies may be obtained

was approved by the Director of the from the American Association on Intellec-
Federal Register in accordance with 5 tual Disability, 1719 Kalorama Rd., NW.,
U.S.C. 552(a) and 1 CFR part 51 that Washington, DC 20009.
105
§ 483.108 42 CFR Ch. IV (10–1–17 Edition)
(2) Exempted hospital discharge. (i) An (1) For individuals with mental ill-
exempted hospital discharge means an ness, must be made by the State men-
individual— tal health authority and be based on an
(A) Who is admitted to any NF di- independent physical and mental eval-
rectly from a hospital after receiving uation performed by a person or entity
acute inpatient care at the hospital; other than the State mental health au-
(B) Who requires NF services for the thority; and
condition for which he or she received (2) For individuals with intellectual
care in the hospital; and disability, must be made by the State
(C) Whose attending physician has intellectual disability or develop-
certified before admission to the facil- mental disabilities authority.
ity that the individual is likely to re- (e) Delegation of responsibility—(1) The
quire less than 30 days nursing facility State mental health and intellectual
services. disability authorities may delegate by
(ii) If an individual who enters a NF subcontract or otherwise the evalua-
as an exempted hospital discharge is tion and determination functions for
later found to require more than 30 which they are responsible to another
days of NF care, the State mental entity only if—
health or intellectual disability au- (i) The State mental health and in-
thority must conduct an annual resi- tellectual disability authorities retain
dent review within 40 calendar days of ultimate control and responsibility for
admission. the performance of their statutory ob-
(3) Readmissions. An individual is a ligations;
readmission if he or she was re- (ii) The two determinations as to the
admitted to a facility from a hospital need for NF services and for specialized
to which he or she was transferred for services are made, based on a con-
the purpose of receiving care. Readmis- sistent analysis of the data; and
sions are subject to annual resident re- (iii) The entity to which the delega-
view rather than preadmission screen- tion is made is not a NF or an entity
ing. that has a direct or indirect affiliation
(4) Interfacility transfers—(i) An inter- or relationship with a NF.
facility transfer occurs when an indi- (2) The State intellectual disability
vidual is transferred from one NF to authority has responsibility for both
another NF, with or without an inter- the evaluation and determination func-
vening hospital stay. Interfacility tions for individuals with IID whereas
transfers are subject to annual resident the State mental health authority has
review rather than preadmission responsibility only for the determina-
screening. tion function.
(ii) In cases of transfer of a resident (3) The evaluation of individuals with
with MI or IID from a NF to a hospital MI cannot be delegated by the State
or to another NF, the transferring NF
mental health authority because it
is responsible for ensuring that copies
does not have responsibility for this
of the resident’s most recent PASARR
function. The evaluation function must
and resident assessment reports accom-
be performed by a person or entity
pany the transferring resident.
other than the State mental health au-
(c) Purpose. The preadmission screen- thority. In designating an independent
ing and annual resident review process person or entity to perform MI evalua-
must result in determinations based on tions, the State must not use a NF or
a physical and mental evaluation of
an entity that has a direct or indirect
each individual with mental illness or
affiliation or relationship with a NF.
intellectual disability, that are de-
scribed in §§ 483.112 and 483.114. [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
(d) Responsibility for evaluations and 28, 1993]
determinations. The PASARR deter-
minations of whether an individual re- § 483.108 Relationship of PASARR to
quires the level of services provided by other Medicaid processes.

a NF and whether specialized services (a) PASARR determinations made by
are needed— the State mental health or intellectual
106
disability authorities cannot be coun- lectual disability authority (as appro-

termanded by the State Medicaid agen- priate) must also determine, in accord-
cy, either in the claims process or ance with § 483.130, whether the indi-
through other utilization control/re- vidual requires specialized services for
view processes or by the State survey the mental illness or intellectual dis-
and certification agency. Only appeals ability, as defined in § 483.120.
determinations made through the sys- (c) Timeliness—(1) Except as specified
tem specified in subpart E of this part in paragraph (c)(4) of this section, a
may overturn a PASARR determina- preadmission screening determination
tion made by the State mental health must be made in writing within an an-
or intellectual disability authorities. nual average of 7 to 9 working days of
(b) In making their determinations, referral of the individual with MI or
however, the State mental health and IID by whatever agent performs the
intellectual disability authorities must Level I identification, under § 483.128(a)
not use criteria relating to the need for of this part, to the State mental health
NF care or specialized services that are or intellectual disability authority for
inconsistent with this regulation and screening. (See § 483.128(a) for discus-
any supplementary criteria adopted by sion of Level I evaluation.)
the State Medicaid agency under its (2) The State may convey determina-
approved State plan. tions verbally to nursing facilities and
(c) To the maximum extent prac- the individual and confirm them in
ticable, in order to avoid duplicative writing.
testing and effort, the PASARR must
(3) The State may compute separate
be coordinated with the routine resi-
annual averages for the mentally ill
dent assessments required by § 483.20(b).
and individuals with intellectual dis-
§ 483.110 Out-of-State arrangements. abilities/developmentally disabled pop-
ulations.
(a) Basic rule. The State in which the
(4) The Secretary may grant an ex-
individual is a State resident (or would
ception to the timeliness standard in
be a State resident at the time he or
paragraph (c)(1) of this section when
she becomes eligible for Medicaid), as
the State—
defined in § 435.403 of this chapter, must
pay for the PASARR and make the re- (i) Exceeds the annual average; and
quired determinations, in accordance (ii) Provides justification satisfac-
with § 431.52(b). tory to the Secretary that a longer
(b) Agreements. A State may include time period was necessary.
arrangements for PASARR in its pro-
§ 483.114 Annual review of NF resi-
vider agreements with out-of-State fa- dents.
cilities or reciprocal interstate agree-
ments. (a) Individuals with mental illness. For
each resident of a NF who has mental
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
illness, the State mental health au-
28, 1993]
thority must determine in accordance
§ 483.112 Preadmission screening of with § 483.130 whether, because of the
applicants for admission to NFs. resident’s physical and mental condi-
(a) Determination of need for NF serv- tion, the resident requires—
ices. For each NF applicant with MI or (1) The level of services provided by—
IID, the State mental health or intel- (i) A NF;
lectual disability authority (as appro- (ii) An inpatient psychiatric hospital
priate) must determine, in accordance for individuals under age 21, as de-
with § 483.130, whether, because of the scribed in section 1905(h) of the Act; or
resident’s physical and mental condi- (iii) An institution for mental dis-
tion, the individual requires the level eases providing medical assistance to
of services provided by a NF. individuals age 65 or older; and
(b) Determination of need for special- (2) Specialized services for mental ill-
ized services. If the individual with men- ness, as defined in § 483.120.
tal illness or intellectual disability is (b) Individuals with intellectual dis-

determined to require a NF level of ability. For each resident of a NF who
care, the State mental health or intel- has intellectual disability, the State
107
§ 483.116 42 CFR Ch. IV (10–1–17 Edition)
intellectual disability or develop- the applicant cannot be admitted. NF

mental disability authority must de- services are not a covered Medicaid
termine in accordance with § 483.130 service for that individual, and further
whether, because of his or her physical screening is not required.
or mental condition, the resident re- (b) Residents who require neither NF
quires— services nor specialized services for MI or
(1) The level of services provided by a IID. If the State mental health or in-
NF or an intermediate care facility for tellectual disability authority deter-
individuals with intellectual disabil- mines that a resident requires neither
ities; and the level of services provided by a NF
(2) Specialized services for intellec- nor specialized services for MI or IID,
tual disability as defined in § 483.120. regardless of the length of stay in the
(c) Frequency of review—(1) A review facility, the State must—
and determination must be conducted (1) Arrange for the safe and orderly
for each resident of a Medicaid NF who discharge of the resident from the fa-
has mental illness or intellectual dis- cility in accordance with § 483.15(b); and
ability not less often than annually. (2) Prepare and orient the resident
(2) ‘‘Annually’’ is defined as occur- for discharge.
ring within every fourth quarter after (c) Residents who do not require NF
the previous preadmission screen or an- services but require specialized services for
nual resident review. MI or IID—(1) Long term residents. Ex-
(d) April 1, 1990 deadline for initial re- cept as otherwise may be provided in
views. The first set of annual reviews an alternative disposition plan adopted
on residents who entered the NF prior under section 1919(e)(7)(E) of the Act,
to January 1, 1989, must be completed for any resident who has continuously
by April 1, 1990. resided in a NF for at least 30 months
before the date of the determination,
§ 483.116 Residents and applicants de- and who requires only specialized serv-
termined to require NF level of ices as defined in § 483.120, the State
services. must, in consultation with the resi-
(a) Individuals needing NF services. If dent’s family or legal representative
the State mental health or intellectual and caregivers—
disability authority determines that a (i) Offer the resident the choice of re-
resident or applicant for admission to a maining in the facility or of receiving
NF requires a NF level of services, the services in an alternative appropriate
NF may admit or retain the individual. setting;
(b) Individuals needing NF services and (ii) Inform the resident of the institu-
specialized services. If the State mental tional and noninstitutional alter-
health or intellectual disability au- natives covered under the State Med-
thority determines that a resident or icaid plan for the resident;
applicant for admission requires both a (iii) Clarify the effect on eligibility
NF level of services and specialized for Medicaid services under the State
services for the mental illness or intel- plan if the resident chooses to leave
lectual disability— the facility, including its effect on re-
(1) The NF may admit or retain the admission to the facility; and
individual; and (iv) Regardless of the resident’s
(2) The State must provide or arrange choice, provide for, or arrange for the
for the provision of the specialized provision of specialized services for the
services needed by the individual while mental illness or intellectual dis-
he or she resides in the NF. ability.
(2) Short term residents. Except as oth-
§ 483.118 Residents and applicants de- erwise may be provided in an alter-
termined not to require NF level of native disposition plan adopted under
services. section 1919(e)(7)(E) of the Act, for any
(a) Applicants who do not require NF resident who requires only specialized
services. If the State mental health or services, as defined in § 483.120, and who
intellectual disability authority deter- has not continuously resided in a NF

mines that an applicant for admission for at least 30 months before the date
to a NF does not require NF services, of the determination, the State must,
108
in consultation with the resident’s (2) For intellectual disability, spe-

family or legal representative and cialized services means the services
caregivers— specified by the State which, combined
(i) Arrange for the safe and orderly with services provided by the NF or
discharge of the resident from the fa- other service providers, results in
cility in accordance with § 483.15(b); treatment which meets the require-
(ii) Prepare and orient the resident ments of § 483.440(a)(1).
for discharge; and (b) Who must receive specialized serv-
(iii) Provide for, or arrange for the ices. The State must provide or arrange
provision of, specialized services for for the provision of specialized serv-
the mental illness or intellectual dis- ices, in accordance with this subpart,
ability. to all NF residents with MI or IID
(3) For the purpose of establishing whose needs are such that continuous
length of stay in a NF, the 30 months of
supervision, treatment and training by
continuous residence in a NF or
qualified mental health or intellectual
longer—
disability personnel is necessary, as
(i) Is calculated back from the date
identified by the screening provided in
of the first annual resident review de-
termination which finds that the indi- § 483.130 or §§ 483.134 and 483.136.
vidual is not in need of NF level of (c) Services of lesser intensity than spe-
services; cialized services. The NF must provide
(ii) May include temporary absences mental health or intellectual disability
for hospitalization or therapeutic services which are of a lesser intensity
leave; and than specialized services to all resi-
(iii) May consist of consecutive residents who need such services.
dences in more than one NF.
§ 483.122 FFP for NF services.
[57 FR 56506, Nov. 30, 1992, as amended at 81
FR 68871, Oct. 4, 2016] (a) Basic rule. Except as otherwise
may be provided in an alternative dis-
§ 483.120 Specialized services. position plan adopted under section
(a) Definition—(1) For mental illness, 1919(e)(7)(E) of the Act, FFP is avail-
specialized services means the services able in State expenditures for NF serv-
specified by the State which, combined ices provided to a Medicaid eligible in-
with services provided by the NF, re- dividual subject to the requirements of
sults in the continuous and aggressive this part only if the individual has
implementation of an individualized been determined—
plan of care that— (1) To need NF care under § 483.116(a)
(i) Is developed and supervised by an or
interdisciplinary team, which includes (2) Not to need NF services but to
a physician, qualified mental health need specialized services, meets the re-
professionals and, as appropriate, other quirements of § 483.118(c)(1), and elects
professionals. to stay in the NF.
(ii) Prescribes specific therapies and (b) FFP for late reviews. When a
activities for the treatment of persons preadmission screening has not been
experiencing an acute episode of seri- performed prior to admission or an an-
ous mental illness, which necessitates nual review is not performed timely, in
supervision by trained mental health accordance with § 483.114(c), but either
personnel; and
is performed at a later date, FFP is
(iii) Is directed toward diagnosing
available only for services furnished
and reducing the resident’s behavioral
after the screening or review has been
symptoms that necessitated institu-
tionalization, improving his or her performed, subject to the provisions of
level of independent functioning, and paragraph (a) of this section.
achieving a functioning level that per-
§ 483.124 FFP for specialized services.
mits reduction in the intensity of men-
tal health services to below the level of FFP is not available for specialized
specialized services at the earliest pos- services furnished to NF residents as
sible time. NF services.
109
§ 483.126 42 CFR Ch. IV (10–1–17 Edition)
§ 483.126 Appropriate placement. there is interdisciplinary coordination

Placement of an individual with MI among the evaluators.
or IID in a NF may be considered ap- (e) The State’s PASARR program
propriate only when the individual’s must use at least the evaluative cri-
needs are such that he or she meets the teria of § 483.130 (if one or both deter-
minimum standards for admission and minations can easily be made categori-
the individual’s needs for treatment do cally as described in § 483.130) or of
not exceed the level of services which §§ 483.132 and 483.134 or § 483.136 (or, in
can be delivered in the NF to which the the case of individuals with both MI
individual is admitted either through and IID, §§ 483.132, 483.134 and 483.136 if
NF services alone or, where necessary, a more extensive individualized evalua-
through NF services supplemented by tion is required).
specialized services provided by or ar- (f) Data. In the case of individualized
ranged for by the State. evaluations, information that is nec-
essary for determining whether it is
§ 483.128 PASARR evaluation criteria. appropriate for the individual with MI
(a) Level I: Identification of individuals or IID to be placed in an NF or in an-
with MI or IID. The State’s PASARR other appropriate setting should be
program must identify all individuals gathered throughout all applicable por-
who are suspected of having MI or IID tions of the PASARR evaluation
as defined in § 483.102. This identifica- (§§ 483.132 and 483.134 and/or § 483.136).
tion function is termed Level I. Level The two determinations relating to the
II is the function of evaluating and de- need for NF level of care and special-
termining whether NF services and ized services are interrelated and must
specialized services are needed. The be based upon a comprehensive anal-
State’s performance of the Level I ysis of all data concerning the indi-
identification function must provide at vidual.
least, in the case of first time identi- (g) Preexisting data. Evaluators may
fications, for the issuance of written use relevant evaluative data, obtained
notice to the individual or resident and prior to initiation of preadmission
his or her legal representative that the screening or annual resident review, if
individual or resident is suspected of the data are considered valid and accu-
having MI or IID and is being referred rate and reflect the current functional
to the State mental health or intellec- status of the individual. However, in
tual disability authority for Level II the case of individualized evaluations,
screening. to supplement and verify the currency
(b) Adaptation to culture, language, and accuracy of existing data, the
ethnic origin. Evaluations performed State’s PASARR program may need to
under PASARR and PASARR notices gather additional information nec-
must be adapted to the cultural back- essary to assess proper placement and
ground, language, ethnic origin and treatment.
means of communication used by the (h) Findings. For both categorical and
individual being evaluated. individualized determinations, findings
(c) Participation by individual and fam- of the evaluation must correspond to
ily. PASARR evaluations must in- the person’s current functional status
volve— as documented in medical and social
(1) The individual being evaluated; history records.
(2) The individual’s legal representa- (i) Evaluation report: Individualized de-
tive, if one has been designated under terminations. For individualized
State law; and PASARR determinations, findings
(3) The individual’s family if— must be issued in the form of a written
(i) Available; and evaluative report which—
(ii) The individual or the legal rep- (1) Identifies the name and profes-
resentative agrees to family participa- sional title of person(s) who performed
tion. the evaluation(s) and the date on which
(d) Interdisciplinary coordination. each portion of the evaluation was ad-
When parts of a PASARR evaluation ministered;

are performed by more than one eval- (2) Provides a summary of the med-
uator, the State must ensure that ical and social history, including the
110
positive traits or developmental (2) Appropriate State authority in

strengths and weaknesses or develop- sufficient time for the State authori-
mental needs of the evaluated indi- ties to meet the times identified in
vidual; § 483.112(c) for PASs and § 483.114(c) for
(3) If NF services are recommended, ARRs;
identifies the specific services which (3) Admitting or retaining NF;
are required to meet the evaluated in- (4) Individual’s attending physician;
dividual’s needs, including services re- and
quired in paragraph (i)(5) of this sec- (5) The discharging hospital if the in-
tion; dividual is seeking NF admission from
(4) If specialized services are not rec- a hospital.
ommended, identifies any specific in- (m) The evaluation may be termi-
tellectual disability or mental health nated if the evaluator finds at any time
services which are of a lesser intensity during the evaluation that the indi-
than specialized services that are re- vidual being evaluated—
quired to meet the evaluated individ- (1) Does not have MI or IID; or
ual’s needs; (2) Has—
(5) If specialized services are rec- (i) A primary diagnosis of dementia
ommended, identifies the specific intel- (including Alzheimer’s Disease or a re-
lectual disability or mental health lated disorder); or
services required to meet the evaluated (ii) A non-primary diagnosis of de-
individual’s needs; and mentia without a primary diagnosis
(6) Includes the bases for the report’s that is a serious mental illness, and
conclusions. does not have a diagnosis of IID or a re-
(j) Evaluation report: Categorical deter- lated condition.
minations. For categorical PASARR de- [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
terminations, findings must be issued 28, 1993]
in the form of an abbreviated written
evaluative report which— § 483.130 PASARR determination cri-
(1) Identifies the name and profes- teria.
sional title of the person applying the (a) Basis for determinations. Deter-
categorical determination and the data minations made by the State mental
on which the application was made; health or intellectual disability au-
(2) Explains the categorical deter- thority as to whether NF level of serv-
mination(s) that has (have) been made ices and specialized services are needed
and, if only one of the two required de- must be based on an evaluation of data
terminations can be made categori- concerning the individual, as specified
cally, describes the nature of any fur- in paragraph (b) of this section.
ther screening which is required; (b) Types of determinations. Deter-
(3) Identifies, to the extent possible, minations may be—
based on the available data, NF serv- (1) Advance group determinations, in
ices, including any mental health or accordance with this section, by cat-
specialized psychiatric rehabilitative egory that take into account that cer-
services, that may be needed; and tain diagnoses, levels of severity of ill-
(4) Includes the bases for the report’s ness, or need for a particular service
conclusions. clearly indicate that admission to or
(k) Interpretation of findings to indi- residence in a NF is normally needed,
vidual. For both categorical and indi- or that the provision of specialized
vidualized determinations, findings of services is not normally needed; or
the evaluation must be interpreted and (2) Individualized determinations
explained to the individual and, where based on more extensive individualized
applicable, to a legal representative evaluations as required in § 483.132,
designated under State law. § 483.134, or § 483.136 (or, in the case of
(l) Evaluation report. The evaluator an individual having both IID and MI,
must send a copy of the evaluation re- §§ 483.134 and 483.136).
port to the— (c) Group determinations by category.

(1) Individual or resident and his or Advance group determinations by cat-
her legal representative; egory developed by the State mental
111
§ 483.130 42 CFR Ch. IV (10–1–17 Edition)
health or intellectual disability au- individual with MI or IID is expected to

thorities may be made applicable to in- return following the brief NF stay.
dividuals by the NF or other evaluator (e) Time limits. The State may specify
following Level I review only if exist- time limits for categorical determina-
ing data on the individual appear to be tions that NF services are needed and
current and accurate and are sufficient in the case of paragraphs (d)(4), (5) and
to allow the evaluator readily to deter- (6) of this section, must specify a time
mine that the individual fits into the limit which is appropriate for provi-
category established by the State au- sional admissions pending further as-
thorities (see § 483.132(c)). Sources of sessment and for emergency situations
existing data on the individual that and respite care. If an individual is
could form the basis for applying a cat- later determined to need a longer stay
egorical determination by the State than the State’s limit allows, the indi-
authorities would be hospital records, vidual must be subjected to an annual
physician’s evaluations, election of resident review before continuation of
hospice status, records of community the stay may be permitted and pay-
mental health centers or community ment made for days of NF care beyond
intellectual disability or develop- the State’s time limit.
mental disability providers. (f) The State mental health and in-
(d) Examples of categories. Examples of tellectual disability authorities may
categories for which the State mental make categorical determinations that
health or intellectual disability au- specialized services are not needed in
thority may make an advance group the provisional, emergency and respite
determination that NF services are admission situations identified in
needed are— § 483.130(d)(4)–(6). In all other cases, ex-
(1) Convalescent care from an acute cept for § 483.130(h), a determination
physical illness which— that specialized services are not needed
must be based on a more extensive in-
(i) Required hospitalization; and
dividualized evaluation under § 483.134
(ii) Does not meet all the criteria for or § 483.136.
an exempt hospital discharge, which is (g) Categorical determinations: No posi-
not subject to preadmission screening, tive specialized treatment determinations.
as specified in § 483.106(b)(2). The State mental health and intellec-
(2) Terminal illness, as defined for tual disability authorities must not
hospice purposes in § 418.3 of this chap- make categorical determinations that
ter; specialized services are needed. Such a
(3) Severe physical illnesses such as determination must be based on a more
coma, ventilator dependence, func- extensive individualized evaluation
tioning at a brain stem level, or diag- under § 483.134 or § 483.136 to determine
noses such as chronic obstructive pul- the exact nature of the specialized
monary disease, Parkinson’s disease, services that are needed.
Huntington’s disease, amyotrophic lat- (h) Categorical determinations: Demen-
eral sclerosis, and congestive heart tia and IID. The State intellectual dis-
failure which result in a level of im- ability authority may make categor-
pairment so severe that the individual ical determinations that individuals
could not be expected to benefit from with dementia, which exists in com-
specialized services; bination with intellectual disability or
(4) Provisional admissions pending a related condition, do not need spe-
further assessment in cases of delirium cialized services.
where an accurate diagnosis cannot be (i) If a State mental health or intel-
made until the delirium clears; lectual disability authority determines
(5) Provisional admissions pending NF needs by category, it may not
further assessment in emergency situa- waive the specialized services deter-
tions requiring protective services, mination. The appropriate State au-
with placement in a nursing facility thority must also determine whether
not to exceed 7 days; and specialized services are needed either
(6) Very brief and finite stays of up to by category (if permitted) or by indi-
a fixed number of days to provide res- vidualized evaluations, as specified in
pite to in-home caregivers to whom the § 483.134 or § 483.136.
112
(j) Recording determinations. All deter- for NF placement and must not be ad-
minations made by the State mental mitted.
health and intellectual disability au- (3) Can be considered appropriate for
thority, regardless of how they are ar- continued placement in a NF. Any NF
rived at, must be recorded in the indi- resident with MI or IID who requires
vidual’s record. the level of services provided by a NF,
(k) Notice of determination. The State regardless of the length of his or her
mental health or intellectual disability stay or the need for specialized serv-
authority must notify in writing the ices, can continue to reside in the NF,
following entities of a determination if the placement is appropriate, as de-
made under this subpart: termined in § 483.126.
(1) The evaluated individual and his (4) May choose to remain in the NF
or her legal representative; even though the placement would other-
(2) The admitting or retaining NF; wise be inappropriate. Any NF resident
(3) The individual or resident’s at- with MI or IID who does not require
tending physician; and the level of services provided by a NF
(4) The discharging hospital, unless but does require specialized services
the individual is exempt from and who has continuously resided in a
preadmission screening as provided for NF for at least 30 consecutive months
at § 483.106(b)(2). before the date of determination may
(l) Contents of notice. Each notice of choose to continue to reside in the fa-
the determination made by the State cility or to receive covered services in
mental health or intellectual disability an alternative appropriate institu-
authority must include— tional or noninstitutional setting.
(1) Whether a NF level of services is Wherever the resident chooses to re-
needed; side, the State must meet his or her
(2) Whether specialized services are specialized services needs. The deter-
needed; mination notice must provide informa-
(3) The placement options that are tion concerning how, when, and by
available to the individual consistent whom the various placement options
with these determinations; and available to the resident will be fully
(4) The rights of the individual to ap- explained to the resident.
peal the determination under subpart E
(5) Cannot be considered appropriate for
of this part.
continued placement in a NF and must be
(m) Placement options. Except as oth-
discharged (short-term residents). Any NF
erwise may be provided in an alter-
resident with MI or IID who does not
native disposition plan adopted under
require the level of services provided
section 1919(e)(7)(E) of the Act, the
by a NF but does require specialized
placement options and the required
State actions are as follows: services and who has resided in a NF
for less than 30 consecutive months
(1) Can be admitted to a NF. Any appli-
cant for admission to a NF who has MI must be discharged in accordance with
or IID and who requires the level of § 483.15(b) to an appropriate setting
services provided by a NF, regardless of where the State must provide special-
whether specialized services are also ized services. The determination notice
needed, may be admitted to a NF, if must provide information on how,
the placement is appropriate, as deter- when, and by whom the resident will be
mined in § 483.126. If specialized serv- advised of discharge arrangements and
ices are also needed, the State is re- of his/her appeal rights under both
sponsible for providing or arranging for PASARR and discharge provisions.
the provision of the specialized serv- (6) Cannot be considered appropriate for
ices. continued placement in a NF and must be
(2) Cannot be admitted to a NF. Any discharged (short or long-term residents).
applicant for admission to a NF who Any NF resident with MI or IID who
has MI or IID and who does not require does not require the level of services
the level of services provided by a NF, provided by a NF and does not require
regardless of whether specialized serv- specialized services regardless of his or
ices are also needed, is inappropriate her length of stay, must be discharged
113
§ 483.132 42 CFR Ch. IV (10–1–17 Edition)
in accordance with § 483.15(b). The de- appropriate setting for meeting the in-
termination notice must provide infor- dividual’s needs in accordance with
mation on how, when, and by whom the § 483.126, another setting such as an
resident will be advised of discharge ar- ICF/IID (including small, community-
rangements and of his or her appeal based facilities), an IMD providing
rights under both PASARR and dis- services to individuals aged 65 or older,
charge provisions. or a psychiatric hospital is an appro-
(n) Specialized services needed in a NF. priate institutional setting for meeting
If a determination is made to admit or those needs.
allow to remain in a NF any individual (b) Determining appropriate placement.
who requires specialized services, the In determining appropriate placement,
determination must be supported by the evaluator must prioritize the phys-
assurances that the specialized services ical and mental needs of the individual
that are needed can and will be pro-
being evaluated, taking into account
vided or arranged for by the State
the severity of each condition.
while the individual resides in the NF.
(o) Record retention. The State (c) Data. At a minimum, the data re-
PASARR system must maintain lied on to make a determination must
records of evaluations and determina- include:
tions, regardless of whether they are (1) Evaluation of physical status (for
performed categorically or individ- example, diagnoses, date of onset, med-
ually, in order to support its deter- ical history, and prognosis);
minations and actions and to protect (2) Evaluation of mental status (for
the appeal rights of individuals sub- example, diagnoses, date of onset, med-
jected to PASARR; and ical history, likelihood that the indi-
(p) Tracking system. The State vidual may be a danger to himself/her-
PASARR system must establish and self or others); and
maintain a tracking system for all in- (3) Functional assessment (activities
dividuals with MI or IID in NFs to en- of daily living).
sure that appeals and future reviews (d) Based on the data compiled in
are performed in accordance with this § 483.132 and, as appropriate, in §§ 483.134
subpart and subpart E. and 483.136, the State mental health or
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. intellectual disability authority must
28, 1993, as amended at 81 FR 68871, Oct. 4, determine whether an NF level of serv-
2016] ices is needed.
§ 483.132 Evaluating the need for NF § 483.134 Evaluating whether an indi-
services and NF level of care vidual with mental illness requires
(PASARR/NF). specialized services (PASARR/MI).
(a) Basic rule. For each applicant for (a) Purpose. The purpose of this sec-
admission to a NF and each NF resi- tion is to identify the minimum data
dent who has MI or IID, the evaluator needs and process requirements for the
must assess whether— State mental health authority, which
(1) The individual’s total needs are is responsible for determining whether
such that his or her needs can be met or not the applicant or resident with
in an appropriate community setting; MI, as defined in § 483.102(b)(1) of this
(2) The individual’s total needs are
part, needs a specialized services pro-
such that they can be met only on an
gram for mental illness as defined in
inpatient basis, which may include the
§ 483.120.
option of placement in a home and
community-based services waiver pro- (b) Data. Minimum data collected
gram, but for which the inpatient care must include—(1) A comprehensive his-
would be required; tory and physical examination of the
(3) If inpatient care is appropriate person. The following areas must be in-
and desired, the NF is an appropriate cluded (if not previously addressed):
institutional setting for meeting those (i) Complete medical history;
needs in accordance with § 483.126; or (ii) Review of all body systems;

(4) If the inpatient care is appro- (iii) Specific evaluation of the per-
priate and desired but the NF is not the son’s neurological system in the areas
114
of motor functioning, sensory func- (C) Comprehensive psychiatric eval-

tioning, gait, deep tendon reflexes, cra- uation;
nial nerves, and abnormal reflexes; and (D) Functional assessment; and
(iv) In case of abnormal findings (ii) To make the determination re-
which are the basis for an NF place- quired in paragraph (d) of this section.
ment, additional evaluations con- (d) Data interpretation. Based on the
ducted by appropriate specialists. data compiled, a qualified mental
(2) A comprehensive drug history in- health professional, as designated by
cluding current or immediate past use the State, must validate the diagnosis
of medications that could mask symp- of mental illness and determine wheth-
toms or mimic mental illness. er a program of psychiatric specialized
services is needed.
(3) A psychosocial evaluation of the
person, including current living ar- § 483.136 Evaluating whether an indi-
rangements and medical and support vidual with intellectual disability
systems. requires specialized services
(4) A comprehensive psychiatric eval- (PASARR/IID).
uation including a complete psy- (a) Purpose. The purpose of this sec-
chiatric history, evaluation of intellec- tion is to identify the minimum data
tual functioning, memory functioning, needs and process requirements for the
and orientation, description of current State intellectual disability authority
attitudes and overt behaviors, affect, to determine whether or not the appli-
suicidal or homicidal ideation, para- cant or resident with intellectual dis-
noia, and degree of reality testing ability, as defined in § 483.102(b)(3) of
(presence and content of delusions) and this part, needs a continuous special-
hallucinations. ized services program, which is analo-
(5) A functional assessment of the in- gous to active treatment, as defined in
dividual’s ability to engage in activi- § 435.1010 of this chapter and § 483.440.
ties of daily living and the level of sup- (b) Data. Minimum data collected
port that would be needed to assist the must include the individual’s com-
individual to perform these activities prehensive history and physical exam-
while living in the community. The as- ination results to identify the fol-
sessment must determine whether this lowing information or, in the absence
level of support can be provided to the of data, must include information that
individual in an alternative commu- permits a reviewer specifically to as-
nity setting or whether the level of sess:
support needed is such that NF place- (1) The individual’s medical prob-
ment is required. lems;
(6) The functional assessment must (2) The level of impact these prob-
address the following areas: Self-moni- lems have on the individual’s inde-
toring of health status, self-admin- pendent functioning;
istering and scheduling of medical (3) All current medications used by
treatment, including medication com- the individual and the current response
pliance, or both, self-monitoring of nu- of the individual to any prescribed
tritional status, handling money, medications in the following drug
dressing appropriately, and grooming. groups:
(i) Hypnotics,
(c) Personnel requirements. (1) If the
(ii) Antipsychotics (neuroleptics),
history and physical examination are
(iii) Mood stabilizers and
not performed by a physician, then a
antidepressants,
physician must review and concur with
(iv) Antianxiety-sedative agents, and
the conclusions. (v) Anti-Parkinson agents.
(2) The State may designate the men- (4) Self-monitoring of health status;
tal health professionals who are quali- (5) Self-administering and scheduling
fied— of medical treatments;
(i) To perform the evaluations re- (6) Self-monitoring of nutritional
quired under paragraph (b) (2)–(6) of status;
this section including the— (7) Self-help development such as

(A) Comprehensive drug history; toileting, dressing, grooming, and eat-
(B) Psychosocial evaluation; ing;
115
§ 483.138 42 CFR Ch. IV (10–1–17 Edition)
(8) Sensorimotor development, such vidual has IID or is a person with a re-
as ambulation, positioning, transfer lated condition and must determine
skills, gross motor dexterity, visual whether specialized services for intel-
motor perception, fine motor dexterity, lectual disability are needed. In mak-
eye-hand coordination, and extent to ing this determination, the State intel-
which prosthetic, orthotic, corrective lectual disability authority must make
or mechanical supportive devices can a qualitative judgment on the extent
improve the individual’s functional ca- to which the person’s status reflects,
pacity; singly and collectively, the character-
(9) Speech and language (communica- istics commonly associated with the
tion) development, such as expressive need for specialized services, includ-
language (verbal and nonverbal), recep- ing—
tive language (verbal and nonverbal), (i) Inability to—
extent to which non-oral communica- (A) Take care of the most personal
tion systems can improve the individ- care needs;
ual’s function capacity, auditory func- (B) Understand simple commands;
tioning, and extent to which amplifi- (C) Communicate basic needs and
cation devices (for example, hearing wants;
aid) or a program of amplification can (D) Be employed at a productive wage
improve the individual’s functional ca- level without systematic long term su-
pacity; pervision or support;
(10) Social development, such as (E) Learn new skills without aggres-
interpersonal skills, recreation-leisure sive and consistent training;
skills, and relationships with others; (F) Apply skills learned in a training
(11) Academic/educational develop- situation to other environments or set-
ment, including functional learning tings without aggressive and con-
skills; sistent training;
(12) Independent living development (G) Demonstrate behavior appro-
such as meal preparation, budgeting priate to the time, situation or place
and personal finances, survival skills, without direct supervision; and
mobility skills (orientation to the
(H) Make decisions requiring in-
neighborhood, town, city), laundry,
formed consent without extreme dif-
housekeeping, shopping, bedmaking,
ficulty;
care of clothing, and orientation skills
(ii) Demonstration of severe
(for individuals with visual impair-
maladaptive behavior(s) that place the
ments);
person or others in jeopardy to health
(13) Vocational development, includ-
and safety; and
ing present vocational skills;
(iii) Presence of other skill deficits or
(14) Affective development such as in-
specialized training needs that neces-
terests, and skills involved with ex-
sitate the availability of trained IID
pressing emotions, making judgments,
personnel, 24 hours per day, to teach
and making independent decisions; and
the person functional skills.
(15) The presence of identifiable
maladaptive or inappropriate behaviors [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
of the individual based on systematic 28, 1993, as amended at 71 FR 39229, July 12,
observation (including, but not limited 2006]
to, the frequency and intensity of iden-
tified maladaptive or inappropriate be- § 483.138 Maintenance of services and
availability of FFP.
haviors).
(c) Data interpretation—(1) The State (a) Maintenance of services. If a NF
must ensure that a licensed psycholo- mails a 30 day notice of its intent to
gist identifies the intellectual func- transfer or discharge a resident, under
tioning measurement of individuals § 483.15(b) of this chapter, the agency
with IID or a related condition. may not terminate or reduce services
(2) Based on the data compiled in until—
paragraph (b) of this section, the State (1) The expiration of the notice pe-
intellectual disability authority, using riod; or

appropriate personnel, as designated by (2) A subpart E appeal, if one has
the State, must validate that the indi- been filed, has been resolved.
116
(b) Availability of FFP. FFP is avail- for any individual who can dem-
able for expenditures for services pro- onstrate to the satisfaction of the
vided to Medicaid beneficiaries dur- State that he or she has served as a
ing— nurse aide at one or more facilities of
(1) The 30 day notice period specified the same employer in the state for at
in § 483.15(b) of this chapter; or least 24 consecutive months before De-
(2) During the period an appeal is in cember 19, 1989; or
progress. (2) Deem an individual to have com-
[57 FR 56506, Nov. 30, 1992, as amended at 81 pleted a nurse aide training and com-
FR 68871, Oct. 4, 2016] petency evaluation program approved
by the State if the individual com-
Subpart D—Requirements That pleted, before July 1, 1989, such a pro-
gram that the State determines would
Must Be Met by States and have met the requirements for ap-
State Agencies: Nurse Aide proval at the time it was offered.
Training and Competency
Evaluation, and Paid Feeding [56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov.
25, 1991, as amended at 60 FR 50443, Sept. 29,
Assistants 1995; 75 FR 21179, Apr. 23, 2010]
SOURCE: 56 FR 48919, Sept. 26, 1991, unless § 483.151 State review and approval of
otherwise noted. nurse aide training and competency
evaluation programs.
§ 483.150 Statutory basis; Deemed (a) State review and administration. (1)
meeting or waiver of requirements. The State—
(a) Statutory basis. This subpart is (i) Must specify any nurse aide train-
based on sections 1819(b)(5), 1819(f)(2), ing and competency evaluation pro-
1919(b)(5), and 1919(f)(2) of the Act, grams that the State approves as meet-
which establish standards for training ing the requirements of § 483.152 and/or
nurse-aides and for evaluating their competency evaluations programs that
competency. the State approves as meeting the re-
(b) Deemed meeting of requirements. A quirements of § 483.154; and
nurse aide is deemed to satisfy the re- (ii) May choose to offer a nurse aide
quirement of completing a training and training and competency evaluation
competency evaluation approved by program that meets the requirements
the State if he or she successfully com- of § 483.152 and/or a competency evalua-
pleted a training and competency eval- tion program that meets the require-
uation program before July 1, 1989 if— ments of § 483.154.
(1) The aide would have satisfied this (2) If the State does not choose to
requirement if— offer a nurse aide training and com-
(i) At least 60 hours were substituted petency evaluation program or com-
for 75 hours in sections 1819(f)(2) and petency evaluation program, the State
1919(f)(2) of the Act, and must review and approve or disapprove
(ii) The individual has made up at nurse aide training and competency
least the difference in the number of evaluation programs and nurse aide
hours in the program he or she com- competency evaluation programs upon
pleted and 75 hours in supervised prac- request.
tical nurse aide training or in regular (3) The State survey agency must in
in-service nurse aide education; the course of all surveys, determine
or whether the nurse aide training and
(2) The individual was found to be competency evaluation requirements
competent (whether or not by the of §§ 483.35(c) and (d) and 483.95(g) are
State) after the completion of nurse met.
aide training of at least 100 hours dura- (b) Requirements for approval of pro-
tion. grams. (1) Before the State approves a
(c) Waiver of requirements. A State nurse aide training and competency
may— evaluation program or competency
(1) Waive the requirement for an indi- evaluation program, the State must—
vidual to complete a competency eval- (i) Determine whether the nurse aide
uation program approved by the State training and competency evaluation
117
§ 483.151 42 CFR Ch. IV (10–1–17 Edition)
program meets the course require- ation of the facility and to ensure the
ments of § 483.152: health and safety of its residents; or
(ii) Determine whether the nurse aide (v) Pursuant to State action, was
competency evaluation program meets closed or had its residents transferred.
the requirements of § 483.154; and (c) Waiver of disapproval of nurse aide
(iii) In all reviews other than the ini- training programs. (1) A facility may re-
tial review, visit the entity providing quest that CMS waive the disapproval
the program. of its nurse aide training program
(2) The State may not approve a when the facility has been assessed a
nurse aide training and competency civil money penalty of not less than
evaluation program or competency $5,000 as adjusted annually under 45
evaluation program offered by or in a CFR part 102 if the civil money penalty
facility which, in the previous two was not related to the quality of care
years— furnished to residents in the facility.
(i) In the case of a skilled nursing fa- (2) For purposes of this provision,
cility, has operated under a waiver ‘‘quality of care furnished to residents’’
under section 1819(b)(4)(C)(ii)(II) of the means the direct hands-on care and
Act; treatment that a health care profes-
(ii) In the case of a nursing facility, sional or direct care staff furnished to
has operated under a waiver under sec- a resident.
tion 1919(b)(4)(C)(ii) of the Act that was (3) Any waiver of disapproval of a
granted on the basis of a demonstra- nurse aide training program does not
tion that the facility is unable to pro- waive any requirement upon the facil-
vide nursing care required under sec- ity to pay any civil money penalty.
tion 1919(b)(4)(C)(i) of the Act for a pe- (d) Time frame for acting on a request
riod in excess of 48 hours per week; for approval. The State must, within 90
(iii) Has been subject to an extended days of the date of a request under
(or partial extended) survey under sec- paragraph (a)(3) of this section or re-
tions 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) ceipt of additional information from
of the Act; the requester—
(iv) Has been assessed a civil money (1) Advise the requester whether or
penalty described in section not the program has been approved; or
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the (2) Request additional information
Act of not less than $5,000 as adjusted form the requesting entity.
annually under 45 CFR part 102; or (e) Duration of approval. The State
(v) Has been subject to a remedy de- may not grant approval of a nurse aide
scribed in sections 1819(h)(2)(B) (i) or training and competency evaluation
(iii), 1819(h)(4), 1919(h)(1)(B)(i), or program for a period longer than 2
1919(h)(2)(A) (i), (iii) or (iv) of the Act. years. A program must notify the
(3) A State may not, until two years State and the State must review that
since the assessment of the penalty (or program when there are substantive
penalties) has elapsed, approve a nurse changes made to that program within
aide training and competency evalua- the 2-year period.
tion program or competency evalua- (f) Withdrawal of approval. (1) The
tion program offered by or in a facility State must withdraw approval of a
that, within the two-year period begin- nurse aide training and competency
ning October 1, 1988— evaluation program or nurse aide com-
(i) Had its participation terminated petency evaluation program offered by
under title XVIII of the Act or under or in a facility described in paragraph
the State plan under title XIX of the (b)(2) of this section.
Act; (2) The State may withdraw approval
(ii) Was subject to a denial of pay- of a nurse aide training and com-
ment under title XVIII or title XIX; petency evaluation program or nurse
(iii) Was assessed a civil money pen- aide competency evaluation program if
alty of not less than $5,000 as adjusted the State determines that any of the
annually under 45 CFR part 102 for defi- applicable requirements of § 483.152 or
ciencies in nursing facility standards; § 483.154 are not met by the program.
(iv) Operated under temporary man- (3) The State must withdraw ap-
agement appointed to oversee the oper- proval of a nurse aide training and
118
competency evaluation program or a which must be in the provision of long

nurse aide competency evaluation pro- term care facility services;
gram if the entity providing the pro- (ii) Instructors must have completed
gram refuses to permit unannounced a course in teaching adults or have ex-
visits by the State. perience in teaching adults or super-
(4) If a State withdraws approval of a vising nurse aides;
nurse aide training and competency (iii) In a facility-based program, the
evaluation program or competency training of nurse aides may be per-
evaluation program— formed under the general supervision
(i) The State must notify the proof the director of nursing for the facil-
gram in writing, indicating the rea- ity who is prohibited from performing
son(s) for withdrawal of approval of the the actual training; and
program. (iv) Other personnel from the health
(ii) Students who have started a professions may supplement the in-
training and competency evaluation structor, including, but not limited to,
program from which approval has been registered nurses, licensed practical/vo-
withdrawn must be allowed to com- cational nurses, pharmacists, dieti-
plete the course. tians, social workers, sanitarians, fire
safety experts, nursing home adminis-
[56 FR 48919, Sept. 26, 1991, as amended at 75 trators, gerontologists, psychologists,
FR 21179, Apr. 23, 2010; 81 FR 61563, Sept. 6,
physical and occupational therapists,
2016; 81 FR 68871, Oct. 4, 2016]
activities specialists, speech/language/
§ 483.152 Requirements for approval of hearing therapists, and resident rights
a nurse aide training and com- experts. Supplemental personnel must
petency evaluation program. have at least 1 year of experience in
their fields;
(a) For a nurse aide training and
(6) Contain competency evaluation
competency evaluation program to be
procedures specified in § 483.154.
approved by the State, it must, at a
(b) The curriculum of the nurse aide
minimum—
training program must include—
(1) Consist of no less than 75 clock (1) At least a total of 16 hours of
hours of training; training in the following areas prior to
(2) Include at least the subjects speci- any direct contact with a resident:
fied in paragraph (b) of this section; (i) Communication and interpersonal
(3) Include at least 16 hours of super- skills;
vised practical training. Supervised (ii) Infection control;
practical training means training in a (iii) Safety/emergency procedures, in-
laboratory or other setting in which cluding the Heimlich maneuver;
the trainee demonstrates knowledge (iv) Promoting residents’ independ-
while performing tasks on an indi- ence; and
vidual under the direct supervision of a (v) Respecting residents’ rights.
registered nurse or a licensed practical (2) Basic nursing skills;
nurse; (i) Taking and recording vital signs;
(4) Ensure that— (ii) Measuring and recording height
(i) Students do not perform any serv- and weight;
ices for which they have not trained (iii) Caring for the residents’ environ-
and been found proficient by the in- ment;
structor; and (iv) Recognizing abnormal changes in
(ii) Students who are providing serv- body functioning and the importance of
ices to residents are under the general reporting such changes to a supervisor;
supervision of a licensed nurse or a reg- and
istered nurse; (v) Caring for residents when death is
(5) Meet the following requirements imminent.
for instructors who train nurse aides; (3) Personal care skills, including,
(i) The training of nurse aides must but not limited to—
be performed by or under the general (i) Bathing;
supervision of a registered nurse who (ii) Grooming, including mouth care;

possesses a minimum of 2 years of (iii) Dressing;
nursing experience, at least 1 year of (iv) Toileting;
119
§ 483.154 42 CFR Ch. IV (10–1–17 Edition)
(v) Assisting with eating and hydra- (v) Maintaining care and security of
tion; residents’ personal possessions;
(vi) Proper feeding techniques; (vi) Promoting the resident’s right to
(vii) Skin care; and be free from abuse, mistreatment, and
(viii) Transfers, positioning, and neglect and the need to report any in-
turning. stances of such treatment to appro-
(4) Mental health and social service priate facility staff;
needs: (vii) Avoiding the need for restraints
(i) Modifying aide’s behavior in rein accordance with current professional
sponse to residents’ behavior; standards.
(ii) Awareness of developmental (c) Prohibition of charges. (1) No
tasks associated with the aging proc- nurse aide who is employed by, or who
ess; has received an offer of employment
(iii) How to respond to resident be- from, a facility on the date on which
havior; the aide begins a nurse aide training
(iv) Allowing the resident to make and competency evaluation program
personal choices, providing and rein- may be charged for any portion of the
forcing other behavior consistent with program (including any fees for text-
the resident’s dignity; and books or other required course mate-
(v) Using the resident’s family as a rials).
source of emotional support. (2) If an individual who is not em-
(5) Care of cognitively impaired resi- ployed, or does not have an offer to be
dents: employed, as a nurse aide becomes em-
(i) Techniques for addressing the ployed by, or receives an offer of em-
unique needs and behaviors of indi- ployment from, a facility not later
vidual with dementia (Alzheimer’s and than 12 months after completing a
others); nurse aide training and competency
(ii) Communicating with cognitively evaluation program, the State must
impaired residents; provide for the reimbursement of costs
(iii) Understanding the behavior of incurred in completing the program on
cognitively impaired residents; a pro rata basis during the period in
(iv) Appropriate responses to the be- which the individual is employed as a
havior of cognitively impaired resi- nurse aide.
dents; and
(v) Methods of reducing the effects of § 483.154 Nurse aide competency eval-
cognitive impairments. uation.
(6) Basic restorative services:
(a) Notification to Individual. The
(i) Training the resident in self care
State must advise in advance any indi-
according to the resident’s abilities;
vidual who takes the competency eval-
(ii) Use of assistive devices in trans-
uation that a record of the successful
ferring, ambulation, eating, and dress-
completion of the evaluation will be in-
ing;
cluded in the State’s nurse aid reg-
(iii) Maintenance of range of motion;
istry.
(iv) Proper turning and positioning in
bed and chair; (b) Content of the competency evalua-
(v) Bowel and bladder training; and tion program—(1) Written or oral exami-
(vi) Care and use of prosthetic and nations. The competency evaluation
orthotic devices. must—
(7) Residents’ Rights. (i) Allow an aide to choose between a
(i) Providing privacy and mainte- written and an oral examination;
nance of confidentiality; (ii) Address each course requirement
(ii) Promoting the residents’ right to specified in § 483.152(b);
make personal choices to accommodate (iii) Be developed from a pool of test
their needs; questions, only a portion of which is
(iii) Giving assistance in resolving used in any one examination;
grievances and disputes; (iv) Use a system that prevents dis-
(iv) Providing needed assistance in closure of both the pool of questions

getting to and participating in resident and the individual competency evalua-
and family groups and other activities; tions; and
120
(v) If oral, must be read from a pre- that the procedure adopted by the fa-
pared text in a neutral manner. cility assures that the competency
(2) Demonstration of skills. The skills evaluation program—
demonstration must consist of a dem- (i) Is secure from tampering;
onstration of randomly selected items (ii) Is standardized and scored by a
drawn from a pool consisting of the testing, educational, or other organiza-
tasks generally performed by nurse tion approved by the State; and
aides. This pool of skills must include (iii) Requires no scoring by facility
all of the personal care skills listed in personnel.
§ 483.152(b)(3). (3) The State must retract the right
(c) Administration of the competency to proctor nurse aide competency eval-
evaluation. (1) The competency exam- uations from facilities in which the
ination must be administered and eval- State finds any evidence of impro-
uated only by— priety, including evidence of tampering
(i) The State directly; or by facility staff.
(ii) A State approved entity which is (e) Successful completion of the com-
neither a skilled nursing facility that petency evaluation program. (1) The
participates in Medicare nor a nursing State must establish a standard for
facility that participates in Medicaid. satisfactory completion of the com-
(2) No nurse aide who is employed by, petency evaluation. To complete the
or who has received an offer of employ- competency evaluation successfully an
ment from, a facility on the date on individual must pass both the written
which the aide begins a nurse aide com- or oral examination and the skills dem-
petency evaluation program may be onstration.
charged for any portion of the pro- (2) A record of successful completion
gram. of the competency evaluation must be
(3) If an individual who is not em- included in the nurse aide registry pro-
ployed, or does not have an offer to be vided in § 483.156 within 30 days of the
employed, as a nurse aide becomes em- date if the individual is found to be
ployed by, or receives an offer of em- competent.
ployment from, a facility not later
(f) Unsuccessful completion of the com-
than 12 months after completing a
petency evaluation program. (1) If the in-
nurse aide competency evaluation pro-
dividual does not complete the evalua-
gram, the State must provide for the
tion satisfactorily, the individual must
reimbursement of costs incurred in
be advised—
completing the program on a pro rata
(i) Of the areas which he or she; did
basis during the period in which the in-
not pass; and
dividual is employed as a nurse aide.
(4) The skills demonstration part of (ii) That he or she has at least three
the evaluation must be— opportunities to take the evaluation.
(i) Performed in a facility or labora- (2) The State may impose a max-
tory setting comparable to the setting imum upon the number of times an in-
in which the individual will function as dividual upon the number of times an
a nurse aide; and individual may attempt to complete
(ii) Administered and evaluated by a the competency evaluation success-
registered nurse with at least one fully, but the maximum may be no less
year’s experience in providing care for than three.
the elderly or the chronically ill of any
§ 483.156 Registry of nurse aides.
age.
(d) Facility proctoring of the com- (a) Establishment of registry. The State
petency evaluation. (1) The competency must establish and maintain a registry
evaluation may, at the nurse aide’s op- of nurse aides that meets the require-
tion, be conducted at the facility in ment of this section. The registry—
which the nurse aide is or will be em- (1) Must include as a minimum the
ployed unless the facility is described information contained in paragraph (c)
in § 483.151(b)(2). of this section:
(2) The State may permit the com- (2) Must be sufficiently accessible to
petency evaluation to be proctored by meet the needs of the public and health
facility personnel if the State finds care providers promptly;
121
§ 483.158 42 CFR Ch. IV (10–1–17 Edition)
(3) May include home health aides through successfully completing a

who have successfully completed a nurse aide training and competency
home health aide competency evalua- evaluation program or competency
tion program approved by the State if evaluation program or by meeting the
home health aides are differentiated requirements of § 483.150; and
from nurse aides; and (iv) The following information on any
(4) Must provide that any response to finding by the State survey agency of
an inquiry that includes a finding of abuse, neglect, or misappropriation of
abuse, neglect, or misappropriation of property by the individual:
property also include any statement (A) Documentation of the State’s in-
disputing the finding made by the vestigation, including the nature of the
nurse aide, as provided under para- allegation and the evidence that led
graph (c)(1)(ix) of this section. the State to conclude that the allega-
(b) Registry operation. (1) The State tion was valid;
may contract the daily operation and (B) The date of the hearing, if the in-
maintenance of the registry to a non- dividual chose to have one, and its out-
State entity. However, the State must come; and
maintain accountability for overall op- (C) A statement by the individual
eration of the registry and compliance disputing the allegation, if he or she
with these regulations. chooses to make one; and
(2) Only the State survey and certifi- (D) This information must be in-
cation agency may place on the reg- cluded in the registry within 10 work-
istry findings of abuse, neglect, or mis- ing days of the finding and must re-
appropriation of property. main in the registry permanently, un-
(3) The State must determine which less the finding was made in error, the
individuals who (i) have successfully individual was found not guilty in a
completed a nurse aide training and court of law, or the State is notified of
competency evaluation program or the individual’s death.
nurse aide competency evaluation pro- (2) The registry must remove entries
gram; (ii) have been deemed as meeting for individuals who have performed no
these requirements; or (iii) have had nursing or nursing-related services for
these requirements waived by the a period of 24 consecutive months, un-
State do not qualify to remain on the less the individual’s registry entry in-
registry because they have performed cludes documented findings of abuse,
no nursing or nursing-related services neglect, or misappropriation of prop-
for a period of 24 consecutive months. erty.
(4) The State may not impose any (d) Disclosure of information. The
charges related to registration on indi- State must—
viduals listed in the registry. (1) Disclose all of the information in
(5) The State must provide informa- § 483.156(c)(1) (iii) and (iv) to all re-
tion on the registry promptly. questers and may disclose additional
(c) Registry Content. (1) The registry information it deems necessary; and
must contain at least the following in- (2) Promptly provide individuals with
formation on each individual who has all information contained in the reg-
successfully completed a nurse aide istry on them when adverse findings
training and competency evaluation are placed on the registry and upon re-
program which meets the requirements quest. Individuals on the registry must
of § 483.152 or a competency evaluation have sufficient opportunity to correct
which meets the requirements of any misstatements or inaccuracies
§ 483.154 and has been found by the contained in the registry.
State to be competent to function as a [56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov.
nurse aide or who may function as a 25, 1991]
nurse aide because of meeting criteria
in § 483.150: § 483.158 FFP for nurse aide training
(i) The individual’s full name. and competency evaluation.
(ii) Information necessary to identify (a) State expenditures for nurse aide
each individual; training and competency evaluation

(iii) The date the individual became programs and competency evaluation
eligible for placement in the registry programs are administrative costs.
122
They are matched as indicated in Subpart E—Appeals of Dis-

§ 433.15(b)(8) of this chapter. charges, Transfers, and
(b) FFP is available for State expend- Preadmission Screening and
itures associated with nurse aide train- Annual Resident Review
ing and competency evaluation pro- (PASARR) Determinations
grams and competency evaluation pro-
grams only for—
SOURCE: 57 FR 56514, Nov. 30, 1992, unless
(1) Nurse aides employed by a facil- otherwise noted.
ity;
(2) Nurse aides who have an offer of § 483.200 Statutory basis.
employment from a facility; This subpart is based on sections
(3) Nurse aides who become employed 1819(e)(3) and (f)(3) and 1919(e)(3) and
by a facility not later than 12 months (f)(3) of the Act, which require States
after completing a nurse aide training to make available, to individuals who
and competency evaluation program or are discharged or transferred from
competency evaluation program; or SNFs or NFs, an appeals process that
(4) Nurse aides who receive an offer of complies with guidelines issued by the
employment from a facility not later Secretary.
than 12 months after completing a [60 FR 50443, Sept. 29, 1995]
nurse aide training and competency
evaluation program or competency § 483.202 Definitions.
evaluation program. For purposes of this subpart and sub-
parts B and C—
§ 483.160 Requirements for training of Discharge means movement from an
paid feeding assistants. entity that participates in Medicare as
(a) Minimum training course con- a skilled nursing facility, a Medicare
tents. A State-approved training certified distinct part, an entity that
course for paid feeding assistants must participates in Medicaid as a nursing
include, at a minimum, 8 hours of facility, or a Medicaid certified dis-
training in the following: tinct part to a noninstitutional setting
when the discharging facility ceases to
(1) Feeding techniques.
be legally responsible for the care of
(2) Assistance with feeding and hy- the resident.
dration. Individual means an individual or any
(3) Communication and interpersonal legal representative of the individual.
skills. Resident means a resident of a SNF or
(4) Appropriate responses to resident NF or any legal representative of the
behavior. resident.
(5) Safety and emergency procedures, Transfer means movement from an
including the Heimlich maneuver. entity that participates in Medicare as
(6) Infection control. a skilled nursing facility, a Medicare
(7) Resident rights. certified distinct part, an entity that
(8) Recognizing changes in residents participates in Medicaid as a nursing
that are inconsistent with their normal facility or a Medicaid certified distinct
part to another institutional setting
behavior and the importance of report-
when the legal responsibility for the
ing those changes to the supervisory
care of the resident changes from the
nurse. transferring facility to the receiving
(b) Maintenance of records. A facility facility.
must maintain a record of all individ-
uals, used by the facility as feeding as- § 483.204 Provision of a hearing and
sistants, who have successfully com- appeal system.
pleted the training course for paid (a) Each State must provide a system
feeding assistants. for:
(1) A resident of a SNF or a NF to ap-
[68 FR 55539, Sept. 26, 2003]

peal a notice from the SNF or NF of in-
tent to discharge or transfer the resi-
dent; and
123
§ 483.206 42 CFR Ch. IV (10–1–17 Edition)
(2) An individual who has been ad- (CMS Pub. 7) which is available for pur-
versely affected by any PASARR deter- chase through the National Technical
mination made by the State in the con- Information Service, 5285 Port Royal
text of either a preadmission screening Rd., Springfield, VA 22151.
or an annual resident review under sub- (c) State requirements in specifying an
part C of part 483 to appeal that deter- RAI. (1) Within 30 days after CMS noti-
mination. fies the State of the CMS-designated
(b) The State must provide an ap- RAI or changes to it, the State must do
peals system that meets the require- one of the following:
ments of this subpart, § 483.15(h), and (i) Specify the CMS-designated RAI.
part 431 subpart E of this chapter. (ii) Notify CMS of its intent to speci-
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
fy an alternate instrument.
28, 1993, as amended at 81 FR 68871, Oct. 4, (2) Within 60 days after receiving
2016] CMS approval of an alternate RAI, the
State must specify the RAI for use by
§ 483.206 Transfers, discharges and re- all long term care facilities partici-
locations subject to appeal. pating in the Medicare and Medicaid
(a) ‘‘Facility’’ means a certified enti- programs.
ty, either a Medicare SNF or a Med- (3) After specifying an instrument,
icaid NF (See § 483.5). the State must provide periodic edu-
(b) A resident has appeal rights when cational programs for facility staff to
he or she is transferred from— assist with implementation of the RAI.
(1) A certified bed into a noncertified (4) A State must audit implementa-
bed; and tion of the RAI through the survey
(2) A bed in a certified entity to a bed process.
in an entity which is certified as a dif- (5) A State must obtain approval
ferent provider. from CMS before making any modifica-
(c) A resident has no appeal rights tions to its RAI.
when he or she is moved from one bed (6) A State must adopt revisions to
in the certified entity to another bed in the RAI that are specified by CMS.
the same certified entity. (d) CMS-designated RAI. The CMS-
designated RAI is published in the
State Operations Manual issued by
FR 68871, Oct. 4, 2016]
CMS (CMS Pub. 7), as updated periodi-
cally, and consists of the following:
Subpart F—Requirements That (1) The minimum data set (MDS) and
Must be Met by States and common definitions.
State Agencies, Resident As- (2) Care area assessment (CAA) guide-
sessment lines and care area triggers (CATs)
that are necessary to accurately assess
§ 483.315 Specification of resident as- residents, established by CMS.
sessment instrument. (3) The quarterly review, based on a
(a) Statutory basis. Sections 1819(e)(5) subset of the MDS specified by CMS.
and 1919(e)(5) of the Act require that a (4) The requirements for use of the
State specify the resident assessment RAI that appear at § 483.20.
instrument (RAI) to be used by long (e) Minimum data set (MDS). The MDS
term care facilities in the State when includes assessment in the areas speci-
conducting initial and periodic assess- fied in § 483.20(b)(i) through (xviii) of
ments of each resident’s functional ca- this chapter, and as defined in the RAI
pacity, in accordance with § 483.20. manual published in the State Oper-
(b) State options in specifying an RAI. ations Manual issued by CMS (CMS
The RAI that the State specifies must Pub. 100–07).
be one of the following: (f) [Reserved]
(1) The instrument designated by (g) Criteria for CMS approval of alter-
CMS. nate instrument. To receive CMS ap-
(2) An alternate instrument specified proval, a State’s alternate instrument
by the State and approved by CMS, must use the standardized format, or-
using the criteria specified in the State ganization, item labels and definitions,
Operations Manual issued by CMS and instructions specified by CMS in
124
the latest issuance of the State Oper- Subpart G—Condition of Partici-

ations Manual issued by CMS (CMS pation for the Use of Restraint
Pub. 7). or Seclusion in Psychiatric
(h) State MDS system and database re- Residential Treatment Facili-
quirements. As part of facility agency ties Providing Inpatient Psy-
responsibilities, the State Survey
Agency must:
chiatric Services for Individ-
(1) Support and maintain the CMS
uals Under Age 21
State system and database.
(2) Specify to a facility the method of SOURCE: 66 FR 7161, Jan. 22, 2001, unless
otherwise noted.
transmission of data, and instruct the
facility on this method. § 483.350 Basis and scope.
(3) Upon receipt of facility data from
CMS, ensure that a facility resolves er- (a) Statutory basis. Sections 1905(a)(16)
and (h) of the Act provide that inpa-
rors.
tient psychiatric services for individ-
(4) Analyze data and generate re-
uals under age 21 include only inpa-
ports, as specified by CMS. tient services that are provided in an
(i) State identification of agency that institution (or distinct part thereof)
receives RAI data. The State must iden- that is a psychiatric hospital as defined
tify the component agency that rein section 1861(f) of the Act or in an-
ceives RAI data, and ensure that this other inpatient setting that the Sec-
agency restricts access to the data ex- retary has specified in regulations. Ad-
cept for the following: ditionally, the Children’s Health Act of
(1) Reports that contain no resident- 2000 (Pub. L. 106–310) imposes proce-
identifiable data. dural reporting and training require-
(2) Transmission of reports to CMS. ments regarding the use of restraints
(3) Transmission of data and reports and involuntary seclusion in facilities,
to the State agency that conducts sur- specifically including facilities that
veys to ensure compliance with Medi- provide inpatient psychiatric services
care and Medicaid participation re- for children under the age of 21 as de-
quirements, for purposes related to this fined by sections 1905(a)(16) and (h) of
function. the Act.
(b) Scope. This subpart imposes re-
(4) Transmission of data and reports
quirements regarding the use of re-
to the State Medicaid agency for pur-
straint or seclusion in psychiatric resi-
poses directly related to the adminis-
dential treatment facilities, that are
tration of the State Medicaid plan. not hospitals, providing inpatient psy-
(5) Transmission of data and reports chiatric services to individuals under
to other entities only when authorized age 21.
as a routine use by CMS.
(j) Resident-identifiable data. (1) The § 483.352 Definitions.
State may not release information that For purposes of this subpart, the fol-
is resident-identifiable to the public. lowing definitions apply:
(2) The State may not release RAI Drug used as a restraint means any
data that is resident-identifiable ex- drug that—
cept in accordance with a written (1) Is administered to manage a resi-
agreement under which the beneficiary dent’s behavior in a way that reduces
agrees to be bound by the restrictions the safety risk to the resident or oth-
described in paragraph (i) of this sec- ers;
tion. (2) Has the temporary effect of re-
[62 FR 67212, Dec. 23, 1997, as amended at 74 stricting the resident’s freedom of
FR 40363, Aug. 11, 2009] movement; and
(3) Is not a standard treatment for
the resident’s medical or psychiatric
condition.
Emergency safety intervention means
the use of restraint or seclusion as an
125
§ 483.354 42 CFR Ch. IV (10–1–17 Edition)
immediate response to an emergency Time out means the restriction of a

safety situation. resident for a period of time to a des-
Emergency safety situation means un- ignated area from which the resident is
anticipated resident behavior that not physically prevented from leaving,
places the resident or others at serious for the purpose of providing the resi-
threat of violence or injury if no inter- dent an opportunity to regain self-con-
vention occurs and that calls for an trol.
emergency safety intervention as de- [66 FR 7161, Jan. 22, 2001, as amended at 66
fined in this section. FR 28116, May 22, 2001]
Mechanical restraint means any device
attached or adjacent to the resident’s § 483.354 General requirements for
body that he or she cannot easily re- psychiatric residential treatment
move that restricts freedom of move- facilities.
ment or normal access to his or her A psychiatric residential treatment
body. facility must meet the requirements in
Minor means a minor as defined § 441.151 through § 441.182 of this chap-
under State law and, for the purpose of ter.
this subpart, includes a resident who
has been declared legally incompetent § 483.356 Protection of residents.
by the applicable State court. (a) Restraint and seclusion policy for
Personal restraint means the applica- the protection of residents. (1) Each resi-
tion of physical force without the use dent has the right to be free from re-
of any device, for the purposes of restraint or seclusion, of any form, used
straining the free movement of a resi- as a means of coercion, discipline, con-
dent’s body. The term personal re- venience, or retaliation.
straint does not include briefly holding (2) An order for restraint or seclusion
without undue force a resident in order must not be written as a standing order
to calm or comfort him or her, or hold- or on an as-needed basis.
ing a resident’s hand to safely escort a (3) Restraint or seclusion must not
resident from one area to another. result in harm or injury to the resident
Psychiatric Residential Treatment Fa- and must be used only—
cility means a facility other than a hos- (i) To ensure the safety of the resi-
pital, that provides psychiatric serv- dent or others during an emergency
ices, as described in subpart D of part safety situation; and
441 of this chapter, to individuals under (ii) Until the emergency safety situa-
age 21, in an inpatient setting. tion has ceased and the resident’s safe-
Restraint means a ‘‘personal re- ty and the safety of others can be en-
straint,’’ ‘‘mechanical restraint,’’ or sured, even if the restraint or seclusion
‘‘drug used as a restraint’’ as defined in order has not expired.
this section. (4) Restraint and seclusion must not
Seclusion means the involuntary con- be used simultaneously.
finement of a resident alone in a room (b) Emergency safety intervention. An
or an area from which the resident is emergency safety intervention must be
physically prevented from leaving. performed in a manner that is safe,
Serious injury means any significant proportionate, and appropriate to the
impairment of the physical condition severity of the behavior, and the resi-
of the resident as determined by quali- dent’s chronological and develop-
fied medical personnel. This includes, mental age; size; gender; physical,
but is not limited to, burns, lacera- medical, and psychiatric condition; and
tions, bone fractures, substantial he- personal history (including any history
matoma, and injuries to internal or- of physical or sexual abuse).
gans, whether self-inflicted or inflicted (c) Notification of facility policy. At ad-
by someone else. mission, the facility must—
Staff means those individuals with re- (1) Inform both the incoming resident
sponsibility for managing a resident’s and, in the case of a minor, the resi-
health or participating in an emer- dent’s parent(s) or legal guardian(s) of
gency safety intervention and who are the facility’s policy regarding the use
employed by the facility on a full-time, of restraint or seclusion during an
part-time, or contract basis. emergency safety situation that may
126
occur while the resident is in the pro- intervention is being initiated by staff
gram; or immediately after the emergency
(2) Communicate its restraint and se- safety situation ends. The physician or
clusion policy in a language that the other licensed practitioner permitted
resident, or his or her parent(s) or legal by the state and the facility to order
guardian(s) understands (including restraint or seclusion must verify the
American Sign Language, if appro- verbal order in a signed written form in
priate) and when necessary, the facility the resident’s record. The physician or
must provide interpreters or trans- other licensed practitioner permitted
lators; by the state and the facility to order
(3) Obtain an acknowledgment, in restraint or seclusion must be avail-
writing, from the resident, or in the able to staff for consultation, at least
case of a minor, from the parent(s) or by telephone, throughout the period of
legal guardian(s) that he or she has the emergency safety intervention.
been informed of the facility’s policy (e) Each order for restraint or seclu-
on the use of restraint or seclusion dur- sion must:
ing an emergency safety situation. (1) Be limited to no longer than the
Staff must file this acknowledgment in duration of the emergency safety situa-
the resident’s record; and tion; and
(4) Provide a copy of the facility pol- (2) Under no circumstances exceed 4
icy to the resident and in the case of a hours for residents ages 18 to 21; 2
minor, to the resident’s parent(s) or hours for residents ages 9 to 17; or 1
legal guardian(s). hour for residents under age 9.
(d) Contact information. The facility’s (f) Within 1 hour of the initiation of
policy must provide contact informa- the emergency safety intervention a
tion, including the phone number and physician, or other licensed practi-
mailing address, for the appropriate tioner trained in the use of emergency
State Protection and Advocacy organi- safety interventions and permitted by
zation. the state and the facility to assess the
physical and psychological well being
§ 483.358 Orders for the use of re-
straint or seclusion. of residents, must conduct a face-to-
face assessment of the physical and
(a) Orders for restraint or seclusion psychological well being of the resi-
must be by a physician, or other li- dent, including but not limited to—
censed practitioner permitted by the (1) The resident’s physical and psy-
State and the facility to order re- chological status;
straint or seclusion and trained in the
(2) The resident’s behavior;
use of emergency safety interventions.
(3) The appropriateness of the inter-
Federal regulations at 42 CFR 441.151
vention measures; and
require that inpatient psychiatric serv-
ices for beneficiaries under age 21 be (4) Any complications resulting from
provided under the direction of a physi- the intervention.
cian. (g) Each order for restraint or seclu-
(b) If the resident’s treatment team sion must include—
physician is available, only he or she (1) The name of the ordering physi-
can order restraint or seclusion. cian or other licensed practitioner per-
(c) A physician or other licensed mitted by the state and the facility to
practitioner permitted by the state and order restraint or seclusion;
the facility to order restraint or seclu- (2) The date and time the order was
sion must order the least restrictive obtained; and
emergency safety intervention that is (3) The emergency safety interven-
most likely to be effective in resolving tion ordered, including the length of
the emergency safety situation based time for which the physician or other
on consultation with staff. licensed practitioner permitted by the
(d) If the order for restraint or seclu- state and the facility to order restraint
sion is verbal, the verbal order must be or seclusion authorized its use.
received by a registered nurse or other (h) Staff must document the inter-
licensed staff such as a licensed prac- vention in the resident’s record. That
tical nurse, while the emergency safety documentation must be completed by
127
§ 483.360 42 CFR Ch. IV (10–1–17 Edition)
the end of the shift in which the inter- § 483.362 Monitoring of the resident in
vention occurs. If the intervention does and immediately after restraint.
not end during the shift in which it (a) Clinical staff trained in the use of
began, documentation must be com- emergency safety interventions must
pleted during the shift in which it ends. be physically present, continually as-
Documentation must include all of the sessing and monitoring the physical
following: and psychological well-being of the
(1) Each order for restraint or seclu- resident and the safe use of restraint
sion as required in paragraph (g) of this throughout the duration of the emer-
section. gency safety intervention.
(2) The time the emergency safety (b) If the emergency safety situation
intervention actually began and ended. continues beyond the time limit of the
(3) The time and results of the 1-hour order for the use of restraint, a reg-
assessment required in paragraph (f) of istered nurse or other licensed staff,
this section. such as a licensed practical nurse,
(4) The emergency safety situation must immediately contact the ordering
that required the resident to be re- physician or other licensed practi-
strained or put in seclusion. tioner permitted by the state and the
facility to order restraint or seclusion
(5) The name of staff involved in the
to receive further instructions.
emergency safety intervention.
(c) A physician, or other licensed
(i) The facility must maintain a practitioner permitted by the state and
record of each emergency safety situa- the facility to evaluate the resident’s
tion, the interventions used, and their well-being and trained in the use of
outcomes. emergency safety interventions, must
(j) The physician or other licensed evaluate the resident’s well-being im-
practitioner permitted by the state and mediately after the restraint is re-
the facility to order restraint or seclu- moved.
sion must sign the restraint or seclu-
[66 FR 7161, Jan. 22, 2001, as amended at 66
sion order in the resident’s record as
FR 28117, May 22, 2001]
soon as possible.
[66 FR 7161, Jan. 22, 2001, as amended at 66 § 483.364 Monitoring of the resident in
FR 28116, May 22, 2001] and immediately after seclusion.
(a) Clinical staff, trained in the use of
§ 483.360 Consultation with treatment emergency safety interventions, must
team physician. be physically present in or imme-
If a physician or other licensed prac- diately outside the seclusion room,
titioner permitted by the state and the continually assessing, monitoring, and
facility to order restraint or seclusion evaluating the physical and psycho-
orders the use of restraint or seclusion, logical well-being of the resident in se-
that person must contact the resident’s clusion. Video monitoring does not
treatment team physician, unless the meet this requirement.
ordering physician is in fact the resi- (b) A room used for seclusion must—
dent’s treatment team physician. The (1) Allow staff full view of the resi-
person ordering the use of restraint or dent in all areas of the room; and
seclusion must— (2) Be free of potentially hazardous
(a) Consult with the resident’s treat- conditions such as unprotected light
ment team physician as soon as pos- fixtures and electrical outlets.
sible and inform the team physician of (c) If the emergency safety situation
the emergency safety situation that re- continues beyond the time limit of the
quired the resident to be restrained or order for the use of seclusion, a reg-
placed in seclusion; and istered nurse or other licensed staff,
such as a licensed practical nurse,
(b) Document in the resident’s record
must immediately contact the ordering
the date and time the team physician
physician or other licensed practi-
was consulted. tioner permitted by the state and the

[66 FR 7161, Jan. 22, 2001, as amended at 66 facility to order restraint or seclusion
FR 28117, May 22, 2001] to receive further instructions.
128
(d) A physician, or other licensed The discussion must provide both the
practitioner permitted by the state and resident and staff the opportunity to
the facility to evaluate the resident’s discuss the circumstances resulting in
well-being and trained in the use of the use of restraint or seclusion and
emergency safety interventions, must strategies to be used by the staff, the
evaluate the resident’s well-being im- resident, or others that could prevent
mediately after the resident is removed the future use of restraint or seclusion.
from seclusion. (b) Within 24 hours after the use of
[66 FR 7161, Jan. 22, 2001, as amended at 66 restraint or seclusion, all staff involved
FR 28117, May 22, 2001] in the emergency safety intervention,
and appropriate supervisory and ad-
§ 483.366 Notification of parent(s) or ministrative staff, must conduct a de-
legal guardian(s). briefing session that includes, at a
If the resident is a minor as defined minimum, a review and discussion of—
in this subpart: (1) The emergency safety situation
(a) The facility must notify the par- that required the intervention, includ-
ent(s) or legal guardian(s) of the resi- ing a discussion of the precipitating
dent who has been restrained or placed factors that led up to the intervention;
in seclusion as soon as possible after (2) Alternative techniques that might
the initiation of each emergency safety have prevented the use of the restraint
intervention. or seclusion;
(b) The facility must document in the
(3) The procedures, if any, that staff
resident’s record that the parent(s) or
are to implement to prevent any recur-
legal guardian(s) has been notified of
rence of the use of restraint or seclu-
the emergency safety intervention, in-
cluding the date and time of notifica- sion; and
tion and the name of the staff person (4) The outcome of the intervention,
providing the notification. including any injuries that may have
resulted from the use of restraint or se-
§ 483.368 Application of time out. clusion.
(a) A resident in time out must never (c) Staff must document in the resi-
be physically prevented from leaving dent’s record that both debriefing ses-
the time out area. sions took place and must include in
(b) Time out may take place away that documentation the names of staff
from the area of activity or from other who were present for the debriefing,
residents, such as in the resident’s names of staff that were excused from
room (exclusionary), or in the area of the debriefing, and any changes to the
activity or other residents resident’s treatment plan that result
(inclusionary). from the debriefings.
(c) Staff must monitor the resident
while he or she is in time out. § 483.372 Medical treatment for inju-
ries resulting from an emergency
§ 483.370 Postintervention debriefings. safety intervention.
(a) Within 24 hours after the use of (a) Staff must immediately obtain
restraint or seclusion, staff involved in medical treatment from qualified med-
an emergency safety intervention and ical personnel for a resident injured as
the resident must have a face-to-face a result of an emergency safety inter-
discussion. This discussion must in- vention.
clude all staff involved in the interven- (b) The psychiatric residential treat-
tion except when the presence of a par- ment facility must have affiliations or
ticular staff person may jeopardize the written transfer agreements in effect
well-being of the resident. Other staff with one or more hospitals approved
and the resident’s parent(s) or legal for participation under the Medicaid
guardian(s) may participate in the program that reasonably ensure that—
disussion when it is deemed appro- (1) A resident will be transferred
priate by the facility. The facility from the facility to a hospital and ad-
must conduct such discussion in a lan- mitted in a timely manner when a

guage that is understood by the resi- transfer is medically necessary for
dent’s parent(s) or legal guardian(s). medical care or acute psychiatric care;
129
§ 483.374 42 CFR Ch. IV (10–1–17 Edition)
(2) Medical and other information clude the name of the resident involved
needed for care of the resident in light in the serious occurrence, a description
of such a transfer, will be exchanged of the occurrence, and the name, street
between the institutions in accordance address, and telephone number of the
with State medical privacy law, includ- facility.
ing any information needed to deter- (2) In the case of a minor, the facility
mine whether the appropriate care can must notify the resident’s parent(s) or
be provided in a less restrictive setting; legal guardian(s) as soon as possible,
and and in no case later than 24 hours after
(3) Services are available to each the serious occurrence.
resident 24 hours a day, 7 days a week. (3) Staff must document in the resi-
(c) Staff must document in the resident’s record that the serious occur-
dent’s record, all injuries that occur as rence was reported to both the State
a result of an emergency safety inter- Medicaid agency and the State-des-
vention, including injuries to staff re- ignated Protection and Advocacy sys-
sulting from that intervention. tem, including the name of the person
(d) Staff involved in an emergency
to whom the incident was reported. A
safety intervention that results in an
copy of the report must be maintained
injury to a resident or staff must meet
in the resident’s record, as well as in
with supervisory staff and evaluate the
the incident and accident report logs
circumstances that caused the injury
kept by the facility.
and develop a plan to prevent future in-
juries. (c) Reporting of deaths. In addition to
the reporting requirements contained
§ 483.374 Facility reporting. in paragraph (b) of this section, facili-
ties must report the death of any resi-
(a) Attestation of facility compliance.
dent to the Centers for Medicare &
Each psychiatric residential treatment
facility that provides inpatient psy- Medicaid Services (CMS) regional of-
chiatric services to individuals under fice.
age 21 must attest, in writing, that the (1) Staff must report the death of any
facility is in compliance with CMS’s resident to the CMS regional office by
standards governing the use of re- no later than close of business the next
straint and seclusion. This attestation business day after the resident’s death.
must be signed by the facility director. (2) Staff must document in the resi-
(1) A facility with a current provider dent’s record that the death was re-
agreement with the Medicaid agency ported to the CMS regional office.
must provide its attestation to the [66 FR 7161, Jan. 22, 2001, as amended at 66
State Medicaid agency by July 21, 2001. FR 28117, May 22, 2001]
(2) A facility enrolling as a Medicaid
provider must meet this requirement § 483.376 Education and training.
at the time it executes a provider
(a) The facility must require staff to
agreement with the Medicaid agency.
(b) Reporting of serious occurrences. have ongoing education, training, and
The facility must report each serious demonstrated knowledge of—
occurrence to both the State Medicaid (1) Techniques to identify staff and
agency and, unless prohibited by State resident behaviors, events, and envi-
law, the State-designated Protection ronmental factors that may trigger
and Advocacy system. Serious occur- emergency safety situations;
rences that must be reported include a (2) The use of nonphysical interven-
resident’s death, a serious injury to a tion skills, such as de-escalation, medi-
resident as defined in § 483.352 of this ation conflict resolution, active listen-
part, and a resident’s suicide attempt. ing, and verbal and observational
(1) Staff must report any serious oc- methods, to prevent emergency safety
currence involving a resident to both situations; and
the State Medicaid agency and the (3) The safe use of restraint and the
State-designated Protection and Advo- safe use of seclusion, including the
cacy system by no later than close of ability to recognize and respond to

business the next business day after a signs of physical distress in residents
serious occurrence. The report must in- who are restrained or in seclusion.
130
(b) Certification in the use of § 483.405 Relationship to other HHS

cardiopulmonary resuscitation, includ- regulations.
ing periodic recertification, is required. In addition to compliance with the
(c) Individuals who are qualified by regulations set forth in this subpart,
education, training, and experience facilities are obliged to meet the appli-
must provide staff training. cable provisions of other HHS regula-
(d) Staff training must include train- tions, including but not limited to
ing exercises in which staff members those pertaining to nondiscrimination
successfully demonstrate in practice on the basis of race, color, or national
the techniques they have learned for origin (45 CFR part 80), nondiscrimina-
managing emergency safety situations. tion on the basis of handicap (45 CFR
(e) Staff must be trained and dem- part 84), nondiscrimination on the
onstrate competency before partici- basis of age (45 CFR part 91), protection
pating in an emergency safety inter- of human subjects of research (45 CFR
vention. part 46), and fraud and abuse (42 CFR
(f) Staff must demonstrate their part 455). Although those regulations
competencies as specified in paragraph are not in themselves considered condi-
(a) of this section on a semiannual tions of participation under this part,
basis and their competencies as speci- their violation may result in the termi-
fied in paragraph (b) of this section on nation or suspension of, or the refusal
an annual basis. to grant or continue, Federal financial
(g) The facility must document in the assistance.
staff personnel records that the train-
ing and demonstration of competency § 483.410 Condition of participation:
were successfully completed. Docu- Governing body and management.
mentation must include the date train- (a) Standard: Governing body. The fa-
ing was completed and the name of per- cility must identify an individual or
sons certifying the completion of train- individuals to constitute the governing
ing. body of the facility. The governing
(h) All training programs and mate- body must—
rials used by the facility must be avail- (1) Exercise general policy, budget,
able for review by CMS, the State Med- and operating direction over the facil-
icaid agency, and the State survey ity;
agency. (2) Set the qualifications (in addition
to those already set by State law, if
Subpart H [Reserved] any) for the administrator of the facil-
ity; and
Subpart I—Conditions of Participa- (3) Appoint the administrator of the
tion for Intermediate Care Fa- facility.
cilities for Individuals with In- (b) Standard: Compliance with Federal,
tellectual Disabilities State, and local laws. The facility must
be in compliance with all applicable
provisions of Federal, State and local
SOURCE: 53 FR 20496, June 3, 1988, unless laws, regulations and codes pertaining
otherwise noted. Redesignated at 56 FR 48918,
to health, safety, and sanitation.
Sept. 26, 1991.
(c) Standard: Client records. (1) The fa-
§ 483.400 Basis and purpose. cility must develop and maintain a rec-
ordkeeping system that includes a sep-
This subpart implements section 1905 arate record for each client and that
(c) and (d) of the Act which gives the documents the client’s health care, ac-
Secretary authority to prescribe regu- tive treatment, social information, and
lations for intermediate care facility protection of the client’s rights.
services in facilities for individuals (2) The facility must keep confiden-
with intellectual disabilities or persons tial all information contained in the

with related conditions. clients’ records, regardless of the form
or storage method of the records.
131
§ 483.420 42 CFR Ch. IV (10–1–17 Edition)
(3) The facility must develop and im- (2) Inform each client, parent (if the
plement policies and procedures gov- client is a minor), or legal guardian, of
erning the release of any client infor- the client’s medical condition, develop-
mation, including consents necessary mental and behavioral status, attend-
from the client, or parents (if the cli- ant risks of treatment, and of the right
ent is a minor) or legal guardian. to refuse treatment;
(4) Any individual who makes an (3) Allow and encourage individual
entry in a client’s record must make it clients to exercise their rights as cli-
legibly, date it, and sign it. ents of the facility, and as citizens of
(5) The facility must provide a legend the United States, including the right
to explain any symbol or abbreviation to file complaints, and the right to due
used in a client’s record. process;
(6) The facility must provide each (4) Allow individual clients to man-
identified residential living unit with age their financial affairs and teach
appropriate aspects of each client’s them to do so to the extent of their ca-
record. pabilities;
(d) Standard: Services provided under (5) Ensure that clients are not sub-
agreements with outside sources. (1) If a jected to physical, verbal, sexual or
service required under this subpart is psychological abuse or punishment;
not provided directly, the facility must (6) Ensure that clients are free from
have a written agreement with an out- unnecessary drugs and physical re-
side program, resource, or service to straints and are provided active treat-
furnish the necessary service, including ment to reduce dependency on drugs
emergency and other health care. and physical restraints;
(2) The agreement must— (7) Provide each client with the op-
(i) Contain the responsibilities, func- portunity for personal privacy and en-
tions, objectives, and other terms sure privacy during treatment and care
agreed to by both parties; and of personal needs;
(ii) Provide that the facility is re- (8) Ensure that clients are not com-
sponsible for assuring that the outside pelled to perform services for the facil-
services meet the standards for quality ity and ensure that clients who do
of services contained in this subpart. work for the facility are compensated
(3) The facility must assure that out- for their efforts at prevailing wages
side services meet the needs of each and commensurate with their abilities;
client. (9) Ensure clients the opportunity to
(4) If living quarters are not provided communicate, associate and meet pri-
in a facility owned by the ICF/IID, the vately with individuals of their choice,
ICF/IID remains directly responsible and to send and receive unopened mail;
for the standards relating to physical (10) Ensure that clients have access
environment that are specified in to telephones with privacy for incom-
§ 483.470 (a) through (g), (j) and (k). ing and outgoing local and long dis-
(e) Standard: Licensure. The facility tance calls except as contraindicated
must be licensed under applicable by factors identified within their indi-
State and local law. vidual program plans;
[53 FR 20496, June 3, 1988. Redesignated at 56 (11) Ensure clients the opportunity to
FR 48918, Sept. 26, 1991, and amended at 57 participate in social, religious, and
FR 43925, Sept. 23, 1992] community group activities;
(12) Ensure that clients have the
§ 483.420 Condition of participation: right to retain and use appropriate per-
Client protections. sonal possessions and clothing, and en-
(a) Standard: Protection of clients’ sure that each client is dressed in his
rights. The facility must ensure the or her own clothing each day; and
rights of all clients. Therefore, the fa- (13) Permit a husband and wife who
cility must— both reside in the facility to share a
(1) Inform each client, parent (if the room.
client is a minor), or legal guardian, of (b) Standard: Client finances. (1) The
the client’s rights and the rules of the facility must establish and maintain a
facility; system that—
132
(i) Assures a full and complete ac- contributes to a nutritionally adequate

counting of clients’ personal funds en- diet.
trusted to the facility on behalf of cli- (iii) The facility must prohibit the
ents; and employment of individuals with a con-
(ii) Precludes any commingling of viction or prior employment history of
client funds with facility funds or with child or client abuse, neglect or mis-
the funds of any person other than an- treatment.
other client. (2) The facility must ensure that all
(2) The client’s financial record must allegations of mistreatment, neglect or
be available on request to the client, abuse, as well as injuries of unknown
parents (if the client is a minor) or source, are reported immediately to
legal guardian. the administrator or to other officials
(c) Standard: Communication with cli- in accordance with State law through
ents, parents, and guardians. The facil- established procedures.
ity must— (3) The facility must have evidence
(1) Promote participation of parents that all alleged violations are thor-
(if the client is a minor) and legal oughly investigated and must prevent
guardians in the process of providing further potential abuse while the inves-
active treatment to a client unless tigation is in progress.
their participation is unobtainable or (4) The results of all investigations
inappropriate; must be reported to the administrator
(2) Answer communications from cli- or designated representative or to
ents’ families and friends promptly and other officials in accordance with
appropriately; State law within five working days of
(3) Promote visits by individuals with the incident and, if the alleged viola-
a relationship to the client (such as tion is verified, appropriate corrective
family, close friends, legal guardians action must be taken.
and advocates) at any reasonable hour,
without prior notice, consistent with § 483.430 Condition of participation:
the right of that client’s and other cli- Facility staffing.
ents’ privacy, unless the interdiscipli- (a) Standard: Qualified intellectual dis-
nary team determines that the visit ability professional. Each client’s active
would not be appropriate; treatment program must be integrated,
(4) Promote visits by parents or coordinated and monitored by a quali-
guardians to any area of the facility fied intellectual disability professional
that provides direct client care serv- who—
ices to the client, consistent with the (1) Has at least one year of experi-
right of that client’s and other clients’ ence working directly with persons
privacy; with intellectual disability or other de-
(5) Promote frequent and informal velopmental disabilities; and
leaves from the facility for visits, trips, (2) Is one of the following:
or vacations; and (i) A doctor of medicine or osteop-
(6) Notify promptly the client’s par- athy.
ents or guardian of any significant in- (ii) A registered nurse.
cidents, or changes in the client’s con- (iii) An individual who holds at least
dition including, but not limited to, se- a bachelor’s degree in a professional
rious illness, accident, death, abuse, or category specified in paragraph (b)(5)
unauthorized absence. of this section.
(d) Standard: Staff treatment of clients. (b) Standard: Professional program
(1) The facility must develop and im- services. (1) Each client must receive
plement written policies and proce- the professional program services need-
dures that prohibit mistreatment, need to implement the active treatment
glect or abuse of the client. program defined by each client’s indi-
(i) Staff of the facility must not use vidual program plan. Professional pro-
physical, verbal, sexual or psycho- gram staff must work directly with cli-
logical abuse or punishment. ents and with paraprofessional, non-

(ii) Staff must not punish a client by professional and other professional pro-
withholding food or hydration that gram staff who work with clients.
133
§ 483.430 42 CFR Ch. IV (10–1–17 Edition)
(2) The facility must have available (A) Hold a graduate degree from a
enough qualified professional staff to school of social work accredited or ap-
carry out and monitor the various pro- proved by the Council on Social Work
fessional interventions in accordance Education or another comparable body;
with the stated goals and objectives of or
every individual program plan. (B) Hold a Bachelor of Social Work
(3) Professional program staff must degree from a college or university ac-
participate as members of the inter- credited or approved by the Council on
disciplinary team in relevant aspects Social Work Education or another
of the active treatment process. comparable body.
(4) Professional program staff must (vii) To be designated as a speech-
participate in on-going staff develop- language pathologist or audiologist, an
ment and training in both formal and individual must—
informal settings with other profes- (A) Be eligible for a Certificate of
sional, paraprofessional, and nonprofes- Clinical Competence in Speech-Lan-
sional staff members. guage Pathology or Audiology granted
(5) Professional program staff must by the American Speech-Language-
be licensed, certified, or registered, as Hearing Association or another com-
applicable, to provide professional parable body; or
services by the State in which he or (B) Meet the educational require-
she practices. Those professional pro- ments for certification and be in the
gram staff who do not fall under the ju- process of accumulating the supervised
risdiction of State licensure, certifi- experience required for certification.
cation, or registration requirements, (viii) To be designated as a profes-
specified in § 483.410(b), must meet the sional recreation staff member, an in-
following qualifications: dividual must have a bachelor’s degree
(i) To be designated as an occupa- in recreation or in a specialty area
tional therapist, an individual must be such as art, dance, music or physical
eligible for certification as an occupa- education.
tional therapist by the American Occu-
(ix) To be designated as a profes-
pational Therapy Association or an-
sional dietitian, an individual must be
other comparable body.
eligible for registration by the Amer-
(ii) To be designated as an occupa-
ican Dietetics Association.
tional therapy assistant, an individual
must be eligible for certification as a (x) To be designated as a human serv-
certified occupational therapy assist- ices professional an individual must
ant by the American Occupational have at least a bachelor’s degree in a
Therapy Association or another com- human services field (including, but
parable body. not limited to: sociology, special edu-
(iii) To be designated as a physical cation, rehabilitation counseling, and
therapist, an individual must be eligi- psychology).
ble for certification as a physical ther- (xi) If the client’s individual program
apist by the American Physical Ther- plan is being successfully implemented
apy Association or another comparable by facility staff, professional program
body. staff meeting the qualifications of
(iv) To be designated as a physical paragraph (b)(5) (i) through (x) of this
therapy assistant, an individual must section are not required—
be eligible for registration by the (A) Except for qualified intellectual
American Physical Therapy Associa- disability professionals;
tion or be a graduate of a two year col- (B) Except for the requirements of
lege-level program approved by the paragraph (b)(2) of this section con-
American Physical Therapy Associa- cerning the facility’s provision of
tion or another comparable body. enough qualified professional program
(v) To be designated as a psycholo- staff; and
gist, an individual must have at least a (C) Unless otherwise specified by
master’s degree in psychology from an State licensure and certification re-
accredited school. quirements.

(vi) To be designated as a social (c) Standard: Facility staffing. (1) The
worker, an individual must— facility must not depend upon clients
134
or volunteers to perform direct care clients, the staff to client ratio is 1 to

services for the facility. 4.
(2) There must be responsible direct (iii) For each defined residential liv-
care staff on duty and awake on a 24- ing unit serving clients who function
hour basis, when clients are present, to within the range of mild retardation,
take prompt, appropriate action in the staff to client ratio is 1 to 6.4.
case of injury, illness, fire or other (4) When there are no clients present
emergency, in each defined residential in the living unit, a responsible staff
living unit housing— member must be available by tele-
(i) Clients for whom a physician has phone.
ordered a medical care plan; (e) Standard: Staff training program.
(ii) Clients who are aggressive, (1) The facility must provide each em-
assaultive or security risks; ployee with initial and continuing
(iii) More than 16 clients; or training that enables the employee to
(iv) Fewer than 16 clients within a perform his or her duties effectively,
multi-unit building. efficiently, and competently.
(3) There must be a responsible direct (2) For employees who work with cli-
care staff person on duty on a 24 hour ents, training must focus on skills and
basis (when clients are present) to re- competencies directed toward clients’
spond to injuries and symptoms of ill- developmental, behavioral, and health
ness, and to handle emergencies, in needs.
each defined residential living unit (3) Staff must be able to demonstrate
housing— the skills and techniques necessary to
(i) Clients for whom a physician has administer interventions to manage
not ordered a medical care plan; the inappropriate behavior of clients.
(ii) Clients who are not aggressive,
(4) Staff must be able to demonstrate
assaultive or security risks; and
the skills and techniques necessary to
(iii) Sixteen or fewer clients,
implement the individual program
(4) The facility must provide suffi-
plans for each client for whom they are
cient support staff so that direct care
responsible.
staff are not required to perform sup-
port services to the extent that these § 483.440 Condition of participation:
duties interfere with the exercise of Active treatment services.
their primary direct client care duties.
(d) Standard: Direct care (residential (a) Standard: Active treatment. (1)
living unit) staff. (1) The facility must Each client must receive a continuous
provide sufficient direct care staff to active treatment program, which in-
manage and supervise clients in ac- cludes aggressive, consistent imple-
cordance with their individual program mentation of a program of specialized
plans. and generic training, treatment, health
(2) Direct care staff are defined as the services and related services described
present on-duty staff calculated over in this subpart, that is directed to-
all shifts in a 24-hour period for each ward—
defined residential living unit. (i) The acquisition of the behaviors
(3) Direct care staff must be provided necessary for the client to function
by the facility in the following min- with as much self determination and
imum ratios of direct care staff to cli- independence as possible; and
ents: (ii) The prevention or deceleration of
(i) For each defined residential living regression or loss of current optimal
unit serving children under the age of functional status.
12, severely and profoundly retarded (2) Active treatment does not include
clients, clients with severe physical services to maintain generally inde-
disabilities, or clients who are aggres- pendent clients who are able to func-
sive, assaultive, or security risks, or tion with little supervision or in the
who manifest severely hyperactive or absence of a continuous active treat-
psychotic-like behavior, the staff to ment program.
client ratio is 1 to 3.2. (b) Standard: Admissions, transfers,

(ii) For each defined residential liv- and discharge. (1) Clients who are ad-
ing unit serving moderately retarded mitted by the facility must be in need
135
§ 483.440 42 CFR Ch. IV (10–1–17 Edition)
of and receiving active treatment serv- (3) Within 30 days after admission,
ices. the interdisciplinary team must per-
(2) Admission decisions must be form accurate assessments or reassess-
based on a preliminary evaluation of ments as needed to supplement the pre-
the client that is conducted or updated liminary evaluation conducted prior to
by the facility or by outside sources. admission. The comprehensive func-
(3) A preliminary evaluation must tional assessment must take into con-
contain background information as sideration the client’s age (for exam-
well as currently valid assessments of ple, child, young adult, elderly person)
functional developmental, behavioral, and the implications for active treat-
social, health and nutritional status to ment at each stage, as applicable, and
determine if the facility can provide must—
for the client’s needs and if the client (i) Identify the presenting problems
is likely to benefit from placement in and disabilities and where possible,
the facility. their causes;
(4) If a client is to be either trans- (ii) Identify the client’s specific de-
ferred or discharged, the facility velopmental strengths;
must— (iii) Identify the client’s specific de-
(i) Have documentation in the cli- velopmental and behavioral manage-
ent’s record that the client was trans- ment needs;
ferred or discharged for good cause; and (iv) Identify the client’s need for
services without regard to the actual
(ii) Provide a reasonable time to pre-
availability of the services needed; and
pare the client and his or her parents
(v) Include physical development and
or guardian for the transfer or dis-
health, nutritional status,
charge (except in emergencies).
sensorimotor development, affective
(5) At the time of the discharge, the
development, speech and language de-
facility must—
velopment and auditory functioning,
(i) Develop a final summary of the cognitive development, social develop-
client’s developmental, behavioral, so- ment, adaptive behaviors or inde-
cial, health and nutritional status and, pendent living skills necessary for the
with the consent of the client, parents client to be able to function in the
(if the client is a minor) or legal guard- community, and as applicable, voca-
ian, provide a copy to authorized per- tional skills.
sons and agencies; and (4) Within 30 days after admission,
(ii) Provide a post-discharge plan of the interdisciplinary team must pre-
care that will assist the client to ad- pare for each client an individual pro-
just to the new living environment. gram plan that states the specific ob-
(c) Standard: Individual program plan. jectives necessary to meet the client’s
(1) Each client must have an individual needs, as identified by the comprehen-
program plan developed by an inter- sive assessment required by paragraph
disciplinary team that represents the (c)(3) of this section, and the planned
professions, disciplines or service areas sequence for dealing with those objec-
that are relevant to— tives. These objectives must—
(i) Identifying the client’s needs, as (i) Be stated separately, in terms of a
described by the comprehensive func- single behavioral outcome;
tional assessments required in para- (ii) Be assigned projected completion
graph (c)(3) of this section; and dates;
(ii) Designing programs that meet (iii) Be expressed in behavioral terms
the client’s needs. that provide measurable indices of per-
(2) Appropriate facility staff must formance;
participate in interdisciplinary team (iv) Be organized to reflect a develop-
meetings. Participation by other agen- mental progression appropriate to the
cies serving the client is encouraged. individual; and
Participation by the client, his or her (v) Be assigned priorities.
parent (if the client is a minor), or the (5) Each written training program de-
client’s legal guardian is required un- signed to implement the objectives in

less that participation is unobtainable the individual program plan must
or inappropriate. specify:
136
(i) The methods to be used; team has formulated a client’s indi-

(ii) The schedule for use of the meth- vidual program plan, each client must
od; receive a continuous active treatment
(iii) The person responsible for the program consisting of needed interven-
program; tions and services in sufficient number
(iv) The type of data and frequency of and frequency to support the achieve-
data collection necessary to be able to ment of the objectives identified in the
assess progress toward the desired ob- individual program plan.
jectives; (2) The facility must develop an ac-
(v) The inappropriate client behav- tive treatment schedule that outlines
ior(s), if applicable; and the current active treatment program
(vi) Provision for the appropriate ex- and that is readily available for review
pression of behavior and the replace- by relevant staff.
ment of inappropriate behavior, if ap- (3) Except for those facets of the indi-
plicable, with behavior that is adaptive vidual program plan that must be im-
or appropriate. plemented only by licensed personnel,
(6) The individual program plan must each client’s individual program plan
also: must be implemented by all staff who
(i) Describe relevant interventions to work with the client, including profes-
support the individual toward inde- sional, paraprofessional and nonprofes-
pendence. sional staff.
(ii) Identify the location where pro- (e) Standard: Program documentation.
gram strategy information (which (1) Data relative to accomplishment of
must be accessible to any person re- the criteria specified in client indi-
sponsible for implementation) can be vidual program plan objectives must be
found. documented in measureable terms.
(iii) Include, for those clients who
(2) The facility must document sig-
lack them, training in personal skills
nificant events that are related to the
essential for privacy and independence
client’s individual program plan and
(including, but not limited to, toilet
assessments and that contribute to an
training, personal hygiene, dental hy-
overall understanding of the client’s
giene, self-feeding, bathing, dressing,
ongoing level and quality of func-
grooming, and communication of basic
tioning.
needs), until it has been demonstrated
(f) Standard: Program monitoring and
that the client is developmentally in-
change. (1) The individual program plan
capable of acquiring them.
must be reviewed at least by the quali-
(iv) Identify mechanical supports, if
fied intellectual disability professional
needed, to achieve proper body posi-
and revised as necessary, including, but
tion, balance, or alignment. The plan
not limited to situations in which the
must specify the reason for each sup-
client—
port, the situations in which each is to
be applied, and a schedule for the use of (i) Has successfully completed an ob-
each support. jective or objectives identified in the
(v) Provide that clients who have individual program plan;
multiple disabling conditions spend a (ii) Is regressing or losing skills al-
major portion of each waking day out ready gained;
of bed and outside the bedroom area, (iii) Is failing to progress toward
moving about by various methods and identified objectives after reasonable
devices whenever possible. efforts have been made; or
(vi) Include opportunities for client (iv) Is being considered for training
choice and self-management. towards new objectives.
(7) A copy of each client’s individual (2) At least annually, the comprehen-
program plan must be made available sive functional assessment of each cli-
to all relevant staff, including staff of ent must be reviewed by the inter-
other agencies who work with the cli- disciplinary team for relevancy and up-
ent, and to the client, parents (if the dated as needed, and the individual
client is a minor) or legal guardian. program plan must be revised, as ap-

(d) Standard: Program implementation. propriate, repeating the process set
(1) As soon as the interdisciplinary forth in paragraph (c) of this section.
137
§ 483.450 42 CFR Ch. IV (10–1–17 Edition)
(3) The facility must designate and (iv) Be available to all staff, clients,
use a specially constituted committee parents of minor children, and legal
or committees consisting of members guardians.
of facility staff, parents, legal guard- (2) To the extent possible, clients
ians, clients (as appropriate), qualified must participate in the formulation of
persons who have either experience or these policies and procedures.
training in contemporary practices to (3) Clients must not discipline other
change inappropriate client behavior, clients, except as part of an organized
and persons with no ownership or con- system of self-government, as set forth
trolling interest in the facility to— in facility policy.
(i) Review, approve, and monitor in- (b) Standard: Management of inappro-
dividual programs designed to manage priate client behavior. (1) The facility
must develop and implement written
inappropriate behavior and other pro-
policies and procedures that govern the
grams that, in the opinion of the com-
management of inappropriate client
mittee, involve risks to client protec-
behavior. These policies and procedures
tion and rights; must be consistent with the provisions
(ii) Insure that these programs are of paragraph (a) of this section. These
conducted only with the written in- procedures must—
formed consent of the client, parent (if (i) Specify all facility approved inter-
the client is a minor), or legal guard- ventions to manage inappropriate cli-
ian; and ent behavior;
(iii) Review, monitor and make sug- (ii) Designate these interventions on
gestions to the facility about its prac- a hierarchy to be implemented, ranging
tices and programs as they relate to from most positive or least intrusive,
drug usage, physical restraints, time- to least positive or most intrusive;
out rooms, application of painful or (iii) Insure, prior to the use of more
noxious stimuli, control of inappro- restrictive techniques, that the client’s
priate behavior, protection of client record documents that programs incor-
rights and funds, and any other area porating the use of less intrusive or
that the committee believes need to be more positive techniques have been
addressed. tried systematically and demonstrated
(4) The provisions of paragraph (f)(3) to be ineffective; and
of this section may be modified only if, (iv) Address the following:
in the judgment of the State survey (A) The use of time-out rooms.
agency, Court decrees, State law or (B) The use of physical restraints.
regulations provide for equivalent cli- (C) The use of drugs to manage inap-
ent protection and consultation. propriate behavior.
(D) The application of painful or nox-
§ 483.450 Condition of participation: ious stimuli.
Client behavior and facility prac- (E) The staff members who may au-
tices. thorize the use of specified interven-
tions.
(a) Standard: Facility practices—Con-
(F) A mechanism for monitoring and
duct toward clients. (1) The facility
controlling the use of such interven-
must develop and implement written
tions.
policies and procedures for the man-
(2) Interventions to manage inappro-
agement of conduct between staff and priate client behavior must be em-
clients. These policies and procedures ployed with sufficient safeguards and
must— supervision to ensure that the safety,
(i) Promote the growth, development welfare and civil and human rights of
and independence of the client; clients are adequately protected.
(ii) Address the extent to which cli- (3) Techniques to manage inappro-
ent choice will be accommodated in priate client behavior must never be
daily decision-making, emphasizing used for disciplinary purposes, for the
self-determination and self-manage- convenience of staff or as a substitute
ment, to the extent possible; for an active treatment program.

(iii) Specify client conduct to be al- (4) The use of systematic interven-
lowed or not allowed; and tions to manage inappropriate client
138
behavior must be incorporated into the (3) The facility must not issue orders
client’s individual program plan, in ac- for restraint on a standing or as needed
cordance with § 483.440(c) (4) and (5) of basis.
this subpart. (4) A client placed in restraint must
(5) Standing or as needed programs to be checked at least every 30 minutes by
control inappropriate behavior are not staff trained in the use of restraints,
permitted. released from the restraint as quickly
(c) Standard: Time-out rooms. (1) A cli- as possible, and a record of these
ent may be placed in a room from checks and usage must be kept.
which egress is prevented only if the
(5) Restraints must be designed and
following conditions are met:
used so as not to cause physical injury
(i) The placement is a part of an ap-
proved systematic time-out program as to the client and so as to cause the
required by paragraph (b) of this sec- least possible discomfort.
tion. (Thus, emergency placement of a (6) Opportunity for motion and exer-
client into a time-out room is not al- cise must be provided for a period of
lowed.) not less than 10 minutes during each
(ii) The client is under the direct con- two hour period in which restraint is
stant visual supervision of designated employed, and a record of such activity
staff. must be kept.
(iii) The door to the room is held (7) Barred enclosures must not be
shut by staff or by a mechanism requir- more than three feet in height and
ing constant physical pressure from a must not have tops.
staff member to keep the mechanism (e) Standard: Drug usage. (1) The facil-
engaged. ity must not use drugs in doses that
(2) Placement of a client in a time- interfere with the individual client’s
out room must not exceed one hour. daily living activities.
(3) Clients placed in time-out rooms (2) Drugs used for control of inappro-
must be protected from hazardous con-
priate behavior must be approved by
ditions including, but not limited to,
the interdisciplinary team and be used
presence of sharp corners and objects,
uncovered light fixtures, unprotected only as an integral part of the client’s
electrical outlets. individual program plan that is di-
(4) A record of time-out activities rected specifically towards the reduc-
must be kept. tion of and eventual elimination of the
(d) Standard: Physical restraints. (1) behaviors for which the drugs are em-
The facility may employ physical re- ployed.
straint only— (3) Drugs used for control of inappro-
(i) As an integral part of an indi- priate behavior must not be used until
vidual program plan that is intended to it can be justified that the harmful ef-
lead to less restrictive means of man- fects of the behavior clearly outweigh
aging and eliminating the behavior for the potentially harmful effects of the
which the restraint is applied; drugs.
(ii) As an emergency measure, but (4) Drugs used for control of inappro-
only if absolutely necessary to protect priate behavior must be—
the client or others from injury; or (i) Monitored closely, in conjunction
(iii) As a health-related protection with the physician and the drug regi-
prescribed by a physician, but only if men review requirement at § 483.460(j),
absolutely necessary during the con- for desired responses and adverse con-
duct of a specific medical or surgical
sequences by facility staff; and
procedure, or only if absolutely nec-
essary for client protection during the (ii) Gradually withdrawn at least an-
time that a medical condition exists. nually in a carefully monitored pro-
(2) Authorizations to use or extend gram conducted in conjunction with
restraints as an emergency must be: the interdisciplinary team, unless clin-
(i) In effect no longer than 12 con- ical evidence justifies that this is con-
secutive hours; and traindicated.

(ii) Obtained as soon as the client is
restrained or stable.
139
§ 483.460 42 CFR Ch. IV (10–1–17 Edition)
§ 483.460 Condition of participation: ing services in accordance with their

Health care services. needs. These services must include—
(a) Standard: Physician services. (1) (1) Participation as appropriate in
The facility must ensure the avail- the development, review, and update of
ability of physician services 24 hours a an individual program plan as part of
day. the interdisciplinary team process;
(2) The physician must develop, in co- (2) The development, with a physi-
ordination with licensed nursing per- cian, of a medical care plan of treat-
sonnel, a medical care plan of treatment for a client when the physician
ment for a client if the physician deter- has determined that an individual cli-
mines that an individual client re- ent requires such a plan;
quires 24-hour licensed nursing care. (3) For those clients certified as not
This plan must be integrated in the in- needing a medical care plan, a review
dividual program plan. of their health status which must—
(3) The facility must provide or ob- (i) Be by a direct physical examina-
tain preventive and general medical tion;
care as well as annual physical exami- (ii) Be by a licensed nurse;
nations of each client that at a min- (iii) Be on a quarterly or more fre-
imum include the following: quent basis depending on client need;
(i) Evaluation of vision and hearing. (iv) Be recorded in the client’s
(ii) Immunizations, using as a guide record; and
the recommendations of the Public (v) Result in any necessary action
Health Service Advisory Committee on (including referral to a physician to ad-
Immunization Practices or of the Com- dress client health problems).
mittee on the Control of Infectious Dis-
(4) Other nursing care as prescribed
eases of the American Academy of Pe-
by the physician or as identified by cli-
diatrics.
ent needs; and
(iii) Routine screening laboratory ex-
(5) Implementing, with other mem-
aminations as determined necessary by
bers of the interdisciplinary team, ap-
the physician, and special studies when
propriate protective and preventive
needed.
health measures that include, but are
(iv) Tuberculosis control, appropriate
not limited to—
to the facility’s population, and in ac-
cordance with the recommendations of (i) Training clients and staff as need-
the American College of Chest Physi- ed in appropriate health and hygiene
cians or the section of diseases of the methods;
chest of the American Academy of Pe- (ii) Control of communicable diseases
diatrics, or both. and infections, including the instruc-
(4) To the extent permitted by State tion of other personnel in methods of
law, the facility may utilize physician infection control; and
assistants and nurse practitioners to (iii) Training direct care staff in de-
provide physician services as described tecting signs and symptoms of illness
in this section. or dysfunction, first aid for accidents
(b) Standard: Physician participation in or illness, and basic skills required to
the individual program plan. A physician meet the health needs of the clients.
must participate in— (d) Standard: Nursing staff. (1) Nurses
(1) The establishment of each newly providing services in the facility must
admitted client’s initial individual pro- have a current license to practice in
gram plan as required by § 456.380 of the State.
this chapter that specified plan of care (2) The facility must employ or ar-
requirements for ICFs; and range for licensed nursing services suf-
(2) If appropriate, physicians must ficient to care for clients health needs
participate in the review and update of including those clients with medical
an individual program plan as part of care plans.
the interdisciplinary team process ei- (3) The facility must utilize reg-
ther in person or through written re- istered nurses as appropriate and re-
port to the interdisciplinary team. quired by State law to perform the

(c) Standard: Nursing services. The fa- health services specified in this sec-
cility must provide clients with nurs- tion.
140
(4) If the facility utilizes only li- (h) Standard: Documentation of dental
censed practical or vocational nurses services. (1) If the facility maintains an
to provide health services, it must have in-house dental service, the facility
a formal arrangement with a registered must keep a permanent dental record
nurse to be available for verbal or on- for each client, with a dental summary
site consultation to the licensed prac- maintained in the client’s living unit.
tical or vocational nurse. (2) If the facility does not maintain
(5) Non-licensed nursing personnel an in-house dental service, the facility
who work with clients under a medical must obtain a dental summary of the
care plan must do so under the super- results of dental visits and maintain
vision of licensed persons. the summary in the client’s living
(e) Standard: Dental services. (1) The unit.
facility must provide or make arrange- (i) Standard: Pharmacy services. The
ments for comprehensive diagnostic facility must provide or make arrange-
and treatment services for each client ments for the provision of routine and
from qualified personnel, including li- emergency drugs and biologicals to its
censed dentists and dental hygienists clients. Drugs and biologicals may be
either through organized dental serv- obtained from community or contract
ices in-house or through arrangement. pharmacists or the facility may main-
(2) If appropriate, dental profes- tain a licensed pharmacy.
sionals must participate, in the devel- (j) Standard: Drug regimen review. (1)
opment, review and update of an indi- A pharmacist with input from the
vidual program plan as part of the interdisciplinary team must review the
interdisciplinary process either in per- drug regimen of each client at least
son or through written report to the quarterly.
interdisciplinary team. (2) The pharmacist must report any
(3) The facility must provide edu- irregularities in clients’ drug regimens
cation and training in the maintenance to the prescribing physician and inter-
of oral health. disciplinary team.
(f) Standard: Comprehensive dental di- (3) The pharmacist must prepare a
agnostic services. Comprehensive dental record of each client’s drug regimen re-
diagnostic services include— views and the facility must maintain
(1) A complete extraoral and that record.
intraoral examination, using all diag- (4) An individual medication admin-
nostic aids necessary to properly evalu- istration record must be maintained
ate the client’s oral condition, not for each client.
later than one month after admission (5) As appropriate the pharmacist
to the facility (unless the examination must participate in the development,
was completed within twelve months implementation, and review of each
before admission); client’s individual program plan either
(2) Periodic examination and diag- in person or through written report to
nosis performed at least annually, in- the interdisciplinary team.
cluding radiographs when indicated (k) Standard: Drug administration. The
and detection of manifestations of sys- facility must have an organized system
temic disease; and for drug administration that identifies
(3) A review of the results of exam- each drug up to the point of adminis-
ination and entry of the results in the tration. The system must assure that—
client’s dental record. (1) All drugs are administered in
(g) Standard: Comprehensive dental compliance with the physician’s orders;
treatment. The facility must ensure (2) All drugs, including those that are
comprehensive dental treatment serv- self-administered, are administered
ices that include— without error;
(1) The availability for emergency (3) Unlicensed personnel are allowed
dental treatment on a 24-hour-a-day to administer drugs only if State law
basis by a licensed dentist; and permits;
(2) Dental care needed for relief of (4) Clients are taught how to admin-
pain and infections, restoration of ister their own medications if the

teeth, and maintenance of dental interdisciplinary team determines that
health. self administration of medications is
141
§ 483.470 42 CFR Ch. IV (10–1–17 Edition)
an appropriate objective, and if the (3) Drugs and biologicals packaged in

physician does not specify otherwise; containers designated for a particular
(5) The client’s physician is informed client must be immediately removed
of the interdisciplinary team’s decision from the client’s current medication
that self-administration of medications supply if discontinued by the physi-
is an objective for the client; cian.
(6) No client self-administers medica- (n) Standard: Laboratory services. (1) If
tions until he or she demonstrates the a facility chooses to provide laboratory
competency to do so; services, the laboratory must meet the
(7) Drugs used by clients while not requirements specified in part 493 of
under the direct care of the facility are this chapter.
packaged and labeled in accordance (2) If the laboratory chooses to refer
with State law; and specimens for testing to another lab-
(8) Drug administration errors and oratory, the referral laboratory must
adverse drug reactions are recorded be certified in the appropriate special-
and reported immediately to a physi- ties and subspecialities of service in ac-
cian. cordance with the requirements of part
(l) Standard: Drug storage and record- 493 of this chapter.
keeping. (1) The facility must store
drugs under proper conditions of sani-
FR 7136, Feb. 28, 1992]
tation, temperature, light, humidity,
and security. § 483.470 Condition of participation:
(2) The facility must keep all drugs Physical environment.
and biologicals locked except when
being prepared for administration. (a) Standard: Client living environment.
Only authorized persons may have ac- (1) The facility must not house clients
cess to the keys to the drug storage of grossly different ages, develop-
area. Clients who have been trained to mental levels, and social needs in close
self administer drugs in accordance physical or social proximity unless the
with § 483.460(k)(4) may have access to housing is planned to promote the
keys to their individual drug supply. growth and development of all those
(3) The facility must maintain housed together.
records of the receipt and disposition of (2) The facility must not segregate
all controlled drugs. clients solely on the basis of their
(4) The facility must, on a sample physical disabilities. It must integrate
basis, periodically reconcile the receipt clients who have ambulation deficits or
and disposition of all controlled drugs who are deaf, blind, or have seizure dis-
in schedules II through IV (drugs sub- orders, etc., with others of comparable
ject to the Comprehensive Drug Abuse social and intellectual development.
Prevention and Control Act of 1970, 21 (b) Standard: Client bedrooms. (1) Bed-
U.S.C. 801 et seq., as implemented by 21 rooms must—
CFR part 308). (i) Be rooms that have at least one
(5) If the facility maintains a li- outside wall;
censed pharmacy, the facility must (ii) Be equipped with or located near
comply with the regulations for con- toilet and bathing facilities;
trolled drugs. (iii) Accommodate no more than four
(m) Standard: Drug labeling. (1) Label- clients unless granted a variance under
ing of drugs and biologicals must— paragraph (b)(3) of this section;
(i) Be based on currently accepted (iv) Measure at least 60 square feet
professional principles and practices; per client in multiple client bedrooms
and and at least 80 square feet in single cli-
(ii) Include the appropriate accessory ent bedrooms; and
and cautionary instructions, as well as (v) In all facilities initially certified,
the expiration date, if applicable. or in buildings constructed or with
(2) The facility must remove from major renovations or conversions on or
use— after October 3, 1988, have walls that
(i) Outdated drugs; and extend from floor to ceiling.

(ii) Drug containers with worn, illegi- (2) If a bedroom is below grade level,
ble, or missing labels. it must have a window that—
142
(i) Is usable as a second means of es- (3) In areas of the facility where cli-
cape by the client(s) occupying the ents who have not been trained to reg-
room; and ulate water temperature are exposed to
(ii) Is no more than 44 inches (meas- hot water, ensure that the temperature
ured to the window sill) above the floor of the water does not exceed 110
unless the facility is surveyed under °Fahrenheit.
the Health Care Occupancy Chapter of (e) Standard: Heating and ventilation.
the Life Safety Code, in which case the (1) Each client bedroom in the facility
window must be no more than 36 inches must have—
(measured to the window sill) above (i) At least one window to the out-
the floor. side; and
(3) The survey agency may grant a (ii) Direct outside ventilation by
variance from the limit of four clients means of windows, air conditioning, or
per room only if a physician who is a mechanical ventilation.
member of the interdisciplinary team (2) The facility must—
and who is a qualified intellectual dis- (i) Maintain the temperature and hu-
ability professional— midity within a normal comfort range
(i) Certifies that each client to be by heating, air conditioning or other
placed in a bedroom housing more than means; and
four persons is so severely medically (ii) Ensure that the heating appa-
impaired as to require direct and con- ratus does not constitute a burn or
tinuous monitoring during sleeping smoke hazard to clients.
hours; and (f) Standard: Floors. The facility must
(ii) Documents the reasons why hous- have—
ing in a room of only four or fewer per- (1) Floors that have a resilient, non-
sons would not be medically feasible. abrasive, and slip-resistant surface;
(4) The facility must provide each cli- (2) Nonabrasive carpeting, if the area
ent with— used by clients is carpeted and serves
(i) A separate bed of proper size and clients who lie on the floor or ambulate
height for the convenience of the cli- with parts of their bodies, other than
ent; feet, touching the floor; and
(ii) A clean, comfortable, mattress; (3) Exposed floor surfaces and floor
(iii) Bedding appropriate to the coverings that promote mobility in
weather and climate; and areas used by clients, and promote
(iv) Functional furniture appropriate maintenance of sanitary conditions.
to the client’s needs, and individual (g) Standard: Space and equipment.
closet space in the client’s bedroom The facility must—
with clothes racks and shelves acces- (1) Provide sufficient space and
sible to the client. equipment in dining, living, health
(c) Standard: Storage space in bedroom. services, recreation, and program areas
The facility must provide— (including adequately equipped and
(1) Space and equipment for daily sound treated areas for hearing and
out-of-bed activity for all clients who other evaluations if they are conducted
are not yet mobile, except those who in the facility) to enable staff to pro-
have a short-term illness or those few vide clients with needed services as re-
clients for whom out-of-bed activity is quired by this subpart and as identified
a threat to health and safety; and in each client’s individual program
(2) Suitable storage space, accessible plan.
to clients, for personal possessions, (2) Furnish, maintain in good repair,
such as TVs, radios, prosthetic equip- and teach clients to use and to make
ment and clothing. informed choices about the use of den-
(d) Standard: Client bathrooms. The fa- tures, eyeglasses, hearing and other
cility must— communications aids, braces, and other
(1) Provide toilet and bathing facili- devices identified by the interdiscipli-
ties appropriate in number, size, and nary team as needed by the client.
design to meet the needs of the clients; (3) Provide adequate clean linen and
(2) Provide for individual privacy in dirty linen storage areas.
toilets, bathtubs, and showers; and (h) [Reserved]
143
§ 483.470 42 CFR Ch. IV (10–1–17 Edition)
(i) Standard: Evacuation drills. (1) The Chapter 33.2.3.5.7.2, Heat detection sys-
facility must hold evacuation drills at tems in attics of the Life Safety Code.
least quarterly for each shift of per- (2) The State survey agency may
sonnel and under varied conditions to— apply a single chapter of the LSC to
(i) Ensure that all personnel on all the entire facility or may apply dif-
shifts are trained to perform assigned ferent chapters to different buildings
tasks; or parts of buildings as permitted by
(ii) Ensure that all personnel on all the LSC.
shifts are familiar with the use of the (3) A facility that meets the LSC def-
facility’s fire protection features; and inition of a residential board and care
(iii) Evaluate the effectiveness of occupancy must have its evacuation
emergency and disaster plans and pro- capability evaluated in accordance
cedures. with the Evacuation Difficulty Index of
(2) The facility must— the Fire Safety Evaluation System for
(i) Actually evacuate clients during Board and Care facilities (FSES/BC).
at least one drill each year on each (4) If CMS finds that the State has a
shift; fire and safety code imposed by State
(ii) Make special provisions for the law that adequately protects a facili-
evacuation of clients with physical dis- ty’s clients, CMS may allow the State
abilities; survey agency to apply the State’s fire
(iii) File a report and evaluation on and safety code instead of the LSC.
each evacuation drill;
(5) Facilities that meet the Life Safety
(iv) Investigate all problems with
Code definition of a health care occu-
evacuation drills, including accidents,
pancy. (i) In consideration of a rec-
and take corrective action; and
ommendation by the State survey
(v) During fire drills, clients may be
agency or Accrediting Organization or
evacuated to a safe area in facilities
at the discretion of the Secretary, may
certified under the Health Care Occu-
waive, for periods deemed appropriate,
pancies Chapter of the Life Safety
specific provisions of the Life Safety
Code.
Code, which would result in unreason-
(3) Facilities must meet the require-
able hardship upon a residential board
ments of paragraphs (i)(1) and (2) of
and care facility, but only if the waiver
this section for any live-in and relief
will not adversely affect the health and
staff they utilize.
safety of the patients.
(j) Standard: Fire protection—(1) Gen-
(ii) A facility may install alcohol-
eral. Except as otherwise provided in
based hand rub dispensers if the dis-
this section—
pensers are installed in a manner that
(i) The facility must meet the appli-
adequately protects against inappro-
cable provisions of either the Health
priate access.
Care Occupancies Chapters or the Resi-
dential Board and Care Occupancies (iii) When a sprinkler system is shut
Chapter and must proceed in accord- down for more than 10 hours, the ICF–
ance with the Life Safety Code (NFPA IID must:
101 and Tentative Interim Amendments (A) Evacuate the building or portion
TIA 12–1, TIA 12–2, TIA 12–3, and TIA of the building affected by the system
12–4.) outage until the system is back in
(ii) Notwithstanding paragraph service, or
(j)(1)(i) of this section, corridor doors (B) Establish a fire watch until the
and doors to rooms containing flam- system is back in service.
mable or combustible materials must (iv) Beginning July 5, 2019, an ICF–
be provided with positive latching IID must be in compliance with Chap-
hardware. Roller latches are prohibited ter 33.2.3.5.7.1, sprinklers in attics, or
on such doors. Chapter 33.2.3.5.7.2, heat detection sys-
(iii) Chapters 32.3.2.11.2 and 33.3.2.11.2 tems in attics of the Life Safety Code.
of the adopted 2012 Life Safety Code do (v) Except as otherwise provided in
not apply to a facility. this section, ICF–IIDs must meet the
(iv) Beginning July 5, 2019, an ICF– applicable provisions and must proceed
IID must be in compliance with Chap- in accordance with the Health Care Fa-
ter 33.2.3.5.7.1, Sprinklers in attics, or cilities Code (NFPA 99 and Tentative
144
Interim Amendments TIA 12–2, TIA 12– (1) National Fire Protection Associa-
3, TIA 12–4, TIA 12–5 and TIA 12–6). tion, 1 Batterymarch Park, Quincy,
(A) Chapter 7,8,12 and 13 of the adopt- MA 02169, www.nfpa.org, 1.617.770.3000.
ed Health Care Facilities Code does not (i) NFPA 99, Standards for Health
apply to an ICF–IID. Care Facilities Code of the National
(B) If application of the Health Care Fire Protection Association 99, 2012
Facilities Code required under para- edition, issued August 11, 2011.
graph (j)(5)(iv) of this section would re- (ii) TIA 12–2 to NFPA 99, issued Au-
sult in unreasonable hardship for the gust 11, 2011.
ICF–IID, CMS may waive specific pro- (iii) TIA 12–3 to NFPA 99, issued Au-
visions of the Health Care Facilities gust 9, 2012.
Code, but only if the waiver does not (iv) TIA 12–4 to NFPA 99, issued
adversely affect the health and safety March 7, 2013.
of clients. (v) TIA 12–5 to NFPA 99, issued Au-
(k) Standard: Paint. The facility gust 1, 2013.
must— (vi) TIA 12–6 to NFPA 99, issued
(1) Use lead-free paint inside the fa- March 3, 2014.
cility; and (vii) NFPA 101, Life Safety Code, 2012
(2) Remove or cover interior paint or edition, issued August 11, 2011;
plaster containing lead so that it is not (viii) TIA 12–1 to NFPA 101, issued
accessible to clients. August 11, 2011.
(l) Standard: Infection control. (1) The (ix) TIA 12–2 to NFPA 101, issued Oc-
facility must provide a sanitary envi- tober 30, 2012.
ronment to avoid sources and trans- (x) TIA 12–3 to NFPA 101, issued Oc-
mission of infections. There must be an tober 22, 2013.
active program for the prevention, con- (xi) TIA 12–4 to NFPA 101, issued Oc-
trol, and investigation of infection and tober 22, 2013.
communicable diseases. (2) [Reserved]
(2) The facility must implement suc-
[53 FR 20496, June 3, 1988. Redesignated at 56
cessful corrective action in affected
FR 48918, Sept. 26, 1991, as amended at 68 FR
problem areas. 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004;
(3) The facility must maintain a 70 FR 15239, Mar. 25, 2005; 71 FR 55340, Sept.
record of incidents and corrective ac- 22, 2006; 81 FR 26900, May 4, 2016; 81 FR 64032,
tions related to infections. Sept. 16, 2016]
(4) The facility must prohibit em-
ployees with symptoms or signs of a § 483.475 Condition of participation:
communicable disease from direct con- Emergency preparedness.
tact with clients and their food. The Intermediate Care Facility for
(m) The standards incorporated by Individuals with Intellectual Disabil-
reference in this section are approved ities (ICF/IID) must comply with all
for incorporation by reference by the applicable Federal, State, and local
Director of the Office of the Federal emergency preparedness requirements.
Register in accordance with 5 U.S.C. The ICF/IID must establish and main-
552(a) and 1 CFR part 51. You may in- tain an emergency preparedness pro-
spect a copy at the CMS Information gram that meets the requirements of
Resource Center, 7500 Security Boule- this section. The emergency prepared-
vard, Baltimore, MD or at the National ness program must include, but not be
Archives and Records Administration limited to, the following elements:
(NARA). For information on the avail- (a) Emergency plan. The ICF/IID must
ability of this material at NARA, call develop and maintain an emergency
202–741–6030, or go to: http:// preparedness plan that must be re-
www.archives.gov/federallregister/ viewed, and updated at least annually.
codeloflfederallregulations/ The plan must do all of the following:
ibrllocations.html. If any changes in (1) Be based on and include a docu-
this edition of the Code are incor- mented, facility-based and community-
porated by reference, CMS will publish based risk assessment, utilizing an all-
a document in the FEDERAL REGISTER hazards approach, including missing
to announce the changes. clients.
145
§ 483.475 42 CFR Ch. IV (10–1–17 Edition)
(2) Include strategies for addressing and treatment needs of evacuees; staff
emergency events identified by the responsibilities; transportation; identi-
risk assessment. fication of evacuation location(s); and
(3) Address the special needs of its primary and alternate means of com-
client population, including, but not munication with external sources of as-
limited to, persons at-risk; the type of sistance.
services the ICF/IID has the ability to (4) A means to shelter in place for cli-
provide in an emergency; and con- ents, staff, and volunteers who remain
tinuity of operations, including delega- in the facility.
tions of authority and succession (5) A system of medical documenta-
plans. tion that preserves client information,
(4) Include a process for cooperation protects confidentiality of client infor-
and collaboration with local, tribal, re- mation, and secures and maintains the
gional, State, and Federal emergency availability of records.
preparedness officials’ efforts to main- (6) The use of volunteers in an emer-
tain an integrated response during a gency or other emergency staffing
disaster or emergency situation, in- strategies, including the process and
cluding documentation of the ICF/IID role for integration of State or Feder-
efforts to contact such officials and, ally designated health care profes-
when applicable, of its participation in sionals to address surge needs during
collaborative and cooperative planning an emergency.
efforts. (7) The development of arrangements
(b) Policies and procedures. The ICF/ with other ICF/IIDs or other providers
IID must develop and implement emer- to receive clients in the event of limi-
gency preparedness policies and proce- tations or cessation of operations to
dures, based on the emergency plan set maintain the continuity of services to
forth in paragraph (a) of this section, ICF/IID clients.
risk assessment at paragraph (a)(1) of (8) The role of the ICF/IID under a
this section, and the communication waiver declared by the Secretary, in
plan at paragraph (c) of this section. accordance with section 1135 of the
The policies and procedures must be re- Act, in the provision of care and treat-
viewed and updated at least annually. ment at an alternate care site identi-
At a minimum, the policies and proce- fied by emergency management offi-
dures must address the following: cials.
(1) The provision of subsistence needs (c) Communication plan. The ICF/IID
for staff and clients, whether they must develop and maintain an emer-
evacuate or shelter in place, include, gency preparedness communication
but are not limited to the following: plan that complies with Federal, State,
(i) Food, water, medical, and pharma- and local laws and must be reviewed
ceutical supplies. and updated at least annually. The
(ii) Alternate sources of energy to communication plan must include the
maintain the following: following:
(A) Temperatures to protect client
(1) Names and contact information
health and safety and for the safe and
for the following:
sanitary storage of provisions.
(i) Staff.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and (ii) Entities providing services under
alarm systems. arrangement.
(D) Sewage and waste disposal. (iii) Clients’ physicians.
(2) A system to track the location of (iv) Other ICF/IIDs.
on-duty staff and sheltered clients in (v) Volunteers.
the ICF/IID’s care during and after an (2) Contact information for the fol-
emergency. If on-duty staff and shel- lowing:
tered clients are relocated during the (i) Federal, State, tribal, regional,
emergency, the ICF/IID must document and local emergency preparedness
the specific name and location of the staff.
receiving facility or other location. (ii) Other sources of assistance.

(3) Safe evacuation from the ICF/IID, (iii) The State Licensing and Certifi-
which includes consideration of care cation Agency.
146
(iv) The State Protection and Advo- (2) Testing. The ICF/IID must conduct
cacy Agency. exercises to test the emergency plan at
(3) Primary and alternate means for least annually. The ICF/IID must do
communicating with the ICF/IID’s the following:
staff, Federal, State, tribal, regional, (i) Participate in a full-scale exercise
and local emergency management that is community-based or when a
agencies. community-based exercise is not acces-
(4) A method for sharing information sible, an individual, facility-based. If
and medical documentation for clients the ICF/IID experiences an actual nat-
under the ICF/IID’s care, as necessary, ural or man-made emergency that re-
with other health care providers to quires activation of the emergency
maintain the continuity of care. plan, the ICF/IID is exempt from en-
(5) A means, in the event of an evacu- gaging in a community-based or indi-
ation, to release client information as vidual, facility-based full-scale exer-
permitted under 45 CFR 164.510(b)(1)(ii). cise for 1 year following the onset of
(6) A means of providing information the actual event.
about the general condition and loca- (ii) Conduct an additional exercise
tion of clients under the facility’s care that may include, but is not limited to
as permitted under 45 CFR 164.510(b)(4). the following:
(7) A means of providing information (A) A second full-scale exercise that
about the ICF/IID’s occupancy, needs, is community-based or individual, fa-
and its ability to provide assistance, to cility-based.
the authority having jurisdiction, the (B) A tabletop exercise that includes
Incident Command Center, or designee. a group discussion led by a facilitator,
(8) A method for sharing information using a narrated, clinically-relevant
from the emergency plan that the fa- emergency scenario, and a set of prob-
cility has determined is appropriate lem statements, directed messages, or
with clients and their families or rep- prepared questions designed to chal-
resentatives. lenge an emergency plan.
(d) Training and testing. The ICF/IID (iii) Analyze the ICF/IID’s response
must develop and maintain an emer- to and maintain documentation of all
gency preparedness training and test- drills, tabletop exercises, and emer-
ing program that is based on the emergency events, and revise the ICF/IID’s
gency plan set forth in paragraph (a) of emergency plan, as needed.
this section, risk assessment at para- (e) Integrated healthcare systems. If an
graph (a)(1) of this section, policies and ICF/IID is part of a healthcare system
procedures at paragraph (b) of this sec- consisting of multiple separately cer-
tion, and the communication plan at tified healthcare facilities that elects
paragraph (c) of this section. The train- to have a unified and integrated emer-
ing and testing program must be re- gency preparedness program, the ICF/
viewed and updated at least annually. IID may choose to participate in the
The ICF/IID must meet the require- healthcare system’s coordinated emer-
ments for evacuation drills and train- gency preparedness program. If elected,
ing at § 483.470(h). the unified and integrated emergency
(1) Training program. The ICF/IID preparedness program must do all of
must do all the following: the following:
(i) Initial training in emergency pre- (1) Demonstrate that each separately
paredness policies and procedures to all certified facility within the system ac-
new and existing staff, individuals pro- tively participated in the development
viding services under arrangement, and of the unified and integrated emer-
volunteers, consistent with their ex- gency preparedness program.
pected roles. (2) Be developed and maintained in a
(ii) Provide emergency preparedness manner that takes into account each
training at least annually. separately certified facility’s unique
(iii) Maintain documentation of the circumstances, patient populations,
training. and services offered.

(iv) Demonstrate staff knowledge of (3) Demonstrate that each separately
emergency procedures. certified facility is capable of actively
147
§ 483.480 42 CFR Ch. IV (10–1–17 Edition)
using the unified and integrated emer- tional Academy of Sciences, adjusted
gency preparedness program and is in for age, sex, disability and activity.
compliance with the program. (b) Standard: Meal services. (1) Each
(4) Include a unified and integrated client must receive at least three
emergency plan that meets the require- meals daily, at regular times com-
ments of paragraphs (a)(2), (3), and (4) parable to normal mealtimes in the
of this section. The unified and inte- community with—
grated emergency plan must also be (i) Not more than 14 hours between a
based on and include all of the fol- substantial evening meal and breakfast
lowing: of the following day, except on week-
(i) A documented community-based ends and holidays when a nourishing
risk assessment, utilizing an all-haz- snack is provided at bedtime, 16 hours
ards approach. may elapse between a substantial
(ii) A documented individual facility- evening meal and breakfast; and
based risk assessment for each sepa- (ii) Not less than 10 hours between
rately certified facility within the breakfast and the evening meal of the
health system, utilizing an all-hazards same day, except as provided under
approach. paragraph (b)(1)(i) of this section.
(5) Include integrated policies and
(2) Food must be served—
procedures that meet the requirements
(i) In appropriate quantity;
set forth in paragraph (b) of this sec-
tion, a coordinated communication (ii) At appropriate temperature;
plan and training and testing programs (iii) In a form consistent with the de-
that meet the requirements of para- velopmental level of the client; and
graphs (c) and (d) of this section, re- (iv) With appropriate utensils.
spectively. (3) Food served to clients individ-
ually and uneaten must be discarded.
[81 FR 64032, Sept. 16, 2016]
(c) Standard: Menus. (1) Menus must—
§ 483.480 Condition of participation: (i) Be prepared in advance;
Dietetic services. (ii) Provide a variety of foods at each
meal;
(a) Standard: Food and nutrition serv-
ices. (1) Each client must receive a (iii) Be different for the same days of
nourishing, well-balanced diet includ- each week and adjusted for seasonal
ing modified and specially-prescribed changes; and
diets. (iv) Include the average portion sizes
(2) A qualified dietitian must be em- for menu items.
ployed either full-time, part-time, or (2) Menus for food actually served
on a consultant basis at the facility’s must be kept on file for 30 days.
discretion. (d) Standard: Dining areas and service.
(3) If a qualified dietitian is not em- The facility must—
ployed full-time, the facility must des- (1) Serve meals for all clients, includ-
ignate a person to serve as the director ing persons with ambulation deficits,
of food services. in dining areas, unless otherwise speci-
(4) The client’s interdisciplinary fied by the interdisciplinary team or a
team, including a qualified dietitian physician;
and physician, must prescribe all modi- (2) Provide table service for all cli-
fied and special diets including those ents who can and will eat at a table, in-
used as a part of a program to manage cluding clients in wheelchairs;
inappropriate client behavior. (3) Equip areas with tables, chairs,
(5) Foods proposed for use as a pri- eating utensils, and dishes designed to
mary reinforcement of adaptive behav- meet the developmental needs of each
ior are evaluated in light of the client’s client;
nutritional status and needs. (4) Supervise and staff dining rooms
(6) Unless otherwise specified by med- adequately to direct self-help dining
ical needs, the diet must be prepared at procedure, to assure that each client
least in accordance with the latest edi- receives enough food and to assure that
tion of the recommended dietary allow- each client eats in a manner consistent
ances of the Food and Nutrition Board with his or her developmental level:
of the National Research Council, Na- and
148
(5) Ensure that each client eats in an 484.210 Data used for the calculation of the
upright position, unless otherwise spec- national prospective 60-day episode pay-
ified by the interdisciplinary team or a ment.
484.215 Initial establishment of the calcula-
physician.
tion of the national 60-day episode pay-
ment.
PART 484—HOME HEALTH 484.220 Calculation of the national adjusted
SERVICES prospective 60-day episode payment rate
for case-mix and area wage levels.
Subpart A—General Provisions 484.225 Annual update of the unadjusted na-
tional prospective 60-day episode pay-
Sec. ment rate.
484.1 Basis and scope. 484.230 Methodology used for the calcula-
484.2 Definitions. tion of the low-utilization payment ad-
484.4 Personnel qualifications. justment.
484.235 Methodology used for the calcula-
Subpart B—Administration tion of the partial episode payment ad-
justment.
484.10 Condition of participation: Patient 484.240 Methodology used for the calcula-
rights. tion of the outlier payment.
484.11 Condition of participation: Release of 484.245 [Reserved]
patient identifiable OASIS information. 484.250 Patient assessment data.
484.12 Condition of participation: Compli- 484.260 Limitation on review.
ance with Federal, State, and local laws, 484.265 Additional payment.
disclosure and ownership information,
and accepted professional standards and Subpart F—Home Health Value-Based Pur-
principles.
484.14 Condition of participation: Organiza-
chasing (HHVBP) Model Components
tion, services, and administration. for Competing Home Health Agencies
484.16 Condition of participation: Group of Within State Boundaries
professional personnel.
484.18 Condition of participation: Accept- 484.300 Basis and scope of subpart.
ance of patients, plan of care, and med- 484.305 Definitions.
ical supervision. 484.310 Applicability of the Home Health
484.20 Condition of participation: Reporting Value-Based Purchasing (HHVBP) Model.
OASIS information. 484.315 Data reporting for measures and
484.22 Condition of participation: Emer- evaluation under the Home Health
gency preparedness. Value-Based Purchasing (HHVBP) Model.
484.320 Calculation of the Total Perform-
Subpart C—Furnishing of Services ance Score.
484.325 Payments for home health services
484.30 Condition of participation: Skilled under Home Health Value-Based Pur-
nursing services. chasing (HHVBP) Model.
484.32 Condition of participation: Therapy 484.330 Process for determining and apply-
services. ing the value-based payment adjustment
484.34 Condition of participation: Medical under the Home Health Value-Based Pur-
social services. chasing (HHVBP) Model.
484.36 Condition of participation: Home 484.335 Appeals process for the Home Health
health aide services. Value-Based Purchasing (HHVBP) Model.
484.38 Condition of participation: Qualifying
to furnish outpatient physical therapy or AUTHORITY: Secs. 1102 and 1871 of the Social
speech pathology services. Security Act (42 U.S.C. 1302 and 1395(hh)) un-
484.48 Condition of participation: Clinical less otherwise indicated.
records. SOURCE: 54 FR 33367, Aug. 14, 1989, unless
484.52 Condition of participation: Evalua- otherwise noted.
tion of the agency’s program.
484.55 Condition of participation: Com-
prehensive assessment of patients. Subpart A—General Provisions
Subpart D [Reserved] § 484.1 Basis and scope.
(a) Basis and scope. This part is based
Subpart E—Prospective Payment System on the indicated provisions of the fol-
for Home Health Agencies lowing sections of the Act:
484.200 Basis and scope. (1) Sections 1861(o) and 1891 establish
484.202 Definitions. the conditions that an HHA must meet
484.205 Basis of payment. in order to participate in Medicare.
149
§ 484.2 42 CFR Ch. IV (10–1–17 Edition)
(2) Section 1861(z) specifies the Insti- Proprietary agency means a private
tutional planning standards that HHAs profit-making agency licensed by the
must meet. State.
(3) Section 1895 provides for the es- Public agency means an agency oper-
tablishment of a prospective payment ated by a State or local government.
system for home health services cov- Subdivision means a component of a
ered under Medicare. multi-function health agency, such as
(b) This part also sets forth addi- the home care department of a hospital
tional requirements that are consid- or the nursing division of a health de-
ered necessary to ensure the health and partment, which independently meets
safety of patients. the conditions of participation for
HHAs. A subdivision that has subunits
FR 41211, July 3, 2000] or branch offices is considered a parent
agency.
§ 484.2 Definitions. Subunit means a semi-autonomous
organization that—
As used in this part, unless the con-
text indicates otherwise—Bylaws or (1) Serves patients in a geographic
equivalent means a set of rules adopted area different from that of the parent
by an HHA for governing the agency’s agency; and
operation. (2) Must independently meet the con-
Branch office means a location or site ditions of participation for HHAs be-
from which a home health agency pro- cause it is too far from the parent
vides services within a portion of the agency to share administration, super-
total geographic area served by the vision, and services on a daily basis.
parent agency. The branch office is Summary report means the compila-
part of the home health agency and is tion of the pertinent factors of a pa-
located sufficiently close to share ad- tient’s clinical notes and progress
ministration, supervision, and services notes that is submitted to the patient’s
in a manner that renders it unneces- physician.
sary for the branch independently to Supervision means authoritative pro-
meet the conditions of participation as cedural guidance by a qualified person
a home health agency. for the accomplishment of a function
Clinical note means a notation of a or activity. Unless otherwise specified
contact with a patient that is written in this part, the supervisor must be on
and dated by a member of the health the premises to supervise an individual
team, and that describes signs and who does not meet the qualifications
symptoms, treatment and drugs admin- specified in § 484.4.
istered and the patient’s reaction, and
§ 484.4 Personnel qualifications.
any changes in physical or emotional
condition. Staff required to meet the conditions
HHA stands for home health agency. set forth in this part are staff who
Nonprofit agency means an agency ex- meet the qualifications specified in
empt from Federal income taxation this section.
under section 501 of the Internal Rev- Administrator, home health agency. A
enue Code of 1954. person who:
Parent home health agency means the (a) Is a licensed physician; or
agency that develops and maintains ad- (b) Is a registered nurse; or
ministrative controls of subunits and/ (c) Has training and experience in
or branch offices. health service administration and at
Primary home health agency means the least 1 year of supervisory or adminis-
agency that is responsible for the serv- trative experience in home health care
ices furnished to patients and for im- or related health programs.
plementation of the plan of care. Audiologist. A person who:
Progress note means a written nota- (a) Meets the education and experi-
tion, dated and signed by a member of ence requirements for a Certificate of
the health team, that summarizes facts Clinical Competence in audiology

about care furnished and the patient’s granted by the American Speech-Lan-
response during a given period of time. guage-Hearing Association; or
150
(b) Meets the educational require- American Occupational Therapy Asso-

ments for certification and is in the ciation, Inc. (AOTA) or successor orga-
process of accumulating the supervised nizations of ACOTE; and
experience required for certification. (ii) Is eligible to take, or has success-
Home health aide. Effective for serv- fully completed the entry-level certifi-
ices furnished after August 14, 1990, a cation examination for occupational
person who has successfully completed therapists developed and administered
a State-established or other training by the National Board for Certification
program that meets the requirements in Occupational Therapy, Inc.,
of § 484.36(a) and a competency evalua- (NBCOT).
tion program or State licensure pro- (c) On or before January 1, 2008—
gram that meets the requirements of (1) Graduated after successful com-
§ 484.36 (b) or (e), or a competency eval- pletion of an occupational therapy pro-
uation program or State licensure program accredited jointly by the com-
gram that meets the requirements of mittee on Allied Health Education and
§ 484.36 (b) or (e). An individual is not Accreditation of the American Medical
considered to have completed a train- Association and the American Occupa-
ing and competency evaluation pro- tional Therapy Association; or
gram, or a competency evaluation pro- (2) Is eligible for the National Reg-
gram if, since the individual’s most re- istration Examination of the American
cent completion of this program(s), Occupational Therapy Association or
there has been a continuous period of the National Board for Certification in
24 consecutive months during none of Occupational Therapy.
which the individual furnished services (d) On or before December 31, 1977—
described in § 409.40 of this chapter for (1) Had 2 years of appropriate experi-
compensation. ence as an occupational therapist; and
Occupational therapist. A person (2) Had achieved a satisfactory grade
who— on an occupational therapist pro-
(a)(1) Is licensed or otherwise regu- ficiency examination conducted, ap-
lated, if applicable, as an occupational proved, or sponsored by the U.S. Public
therapist by the State in which prac- Health Service.
ticing, unless licensure does not apply; (e) If educated outside the United
(2) Graduated after successful com- States, must meet all of the following:
pletion of an occupational therapist (1) Graduated after successful com-
education program accredited by the pletion of an occupational therapist
Accreditation Council for Occupational education program accredited as sub-
Therapy Education (ACOTE) of the stantially equivalent to occupational
American Occupational Therapy Asso- therapist entry level education in the
ciation, Inc. (AOTA), or successor orga- United States by one of the following:
nizations of ACOTE; and (i) The Accreditation Council for Oc-
(3) Is eligible to take, or has success- cupational Therapy Education
fully completed the entry-level certifi- (ACOTE).
cation examination for occupational (ii) Successor organizations of
therapists developed and administered ACOTE.
by the National Board for Certification (iii) The World Federation of Occupa-
in Occupational Therapy, Inc. tional Therapists.
(NBCOT). (iv) A credentialing body approved by
(b) On or before December 31, 2009— the American Occupational Therapy
(1) Is licensed or otherwise regulated, Association.
if applicable, as an occupational thera- (2) Successfully completed the entry-
pist by the State in which practicing; level certification examination for oc-
or cupational therapists developed and
(2) When licensure or other regula- administered by the National Board for
tion does not apply— Certification in Occupational Therapy,
(i) Graduated after successful com- Inc. (NBCOT).
pletion of an occupational therapist (3) On or before December 31, 2009, is
education program accredited by the licensed or otherwise regulated, if ap-

Accreditation Council for Occupational plicable, as an occupational therapist
Therapy Education (ACOTE) of the by the State in which practicing.
151
§ 484.4 42 CFR Ch. IV (10–1–17 Edition)
Occupational therapy assistant. A per- proved, or sponsored by the U.S. Public

son who— Health Service.
(a) Meets all of the following: (e) If educated outside the United
(1) Is licensed, unless licensure does States, on or after January 1, 2008—
not apply, or otherwise regulated, if (1) Graduated after successful com-
applicable, as an occupational therapy pletion of an occupational therapy as-
assistant by the State in which prac- sistant education program that is ac-
ticing. credited as substantially equivalent to
(2) Graduated after successful com- occupational therapist assistant entry
pletion of an occupational therapy as- level education in the United States
sistant education program accredited by—
by the Accreditation Council for Occu- (i) The Accreditation Council for Oc-
pational Therapy Education, (ACOTE) cupational Therapy Education
of the American Occupational Therapy (ACOTE).
Association, Inc. (AOTA) or its suc- (ii) Its successor organizations.
cessor organizations. (iii) The World Federation of Occupa-
(3) Is eligible to take or successfully tional Therapists.
completed the entry-level certification (iv) By a credentialing body approved
examination for occupational therapy by the American Occupational Therapy
assistants developed and administered Association; and
by the National Board for Certification
(2) Successfully completed the entry-
in Occupational Therapy, Inc.
level certification examination for oc-
(NBCOT).
cupational therapy assistants devel-
(b) On or before December 31, 2009—
oped and administered by the National
(1) Is licensed or otherwise regulated
Board for Certification in Occupational
as an occupational therapy assistant, if
Therapy, Inc. (NBCOT).
applicable, by the State in which prac-
Physical therapist. A person who is li-
ticing; or any qualifications defined by
censed, if applicable, by the State in
the State in which practicing, unless
which practicing, unless licensure does
licensure does not apply; or
not apply and meets one of the fol-
(2) Must meet both of the following:
lowing requirements:
(i) Completed certification require-
ments to practice as an occupational (a)(1) Graduated after successful
therapy assistant established by a completion of a physical therapist edu-
credentialing organization approved by cation program approved by one of the
the American Occupational Therapy following:
Association. (i) The Commission on Accreditation
(ii) After January 1, 2010, meets the in Physical Therapy Education
requirements in paragraph (a) of this (CAPTE).
section. (ii) Successor organizations of
(c) After December 31, 1977 and on or CAPTE.
before December 31, 2007— (iii) An education program outside
(1) Completed certification require- the United States determined to be
ments to practice as an occupational substantially equivalent to physical
therapy assistant established by a therapist entry-level education in the
credentialing organization approved by United States by a credentials evalua-
the American Occupational Therapy tion organization approved by the
Association; or American Physical Therapy Associa-
(2) Completed the requirements to tion or an organization identified in 8
practice as an occupational therapy as- CFR 212.15(e) as it relates to physical
sistant applicable in the State in which therapists; and
practicing. (2) Passed an examination for phys-
(d) On or before December 31, 1977— ical therapists approved by the State
(1) Had 2 years of appropriate experi- in which physical therapy services are
ence as an occupational therapy assist- provided.
ant; and (b) On or before December 31, 2009—
(2) Had achieved a satisfactory grade (1) Graduated after successful com-
on an occupational therapy assistant pletion of a physical therapy cur-
proficiency examination conducted, ap- riculum approved by the Commission
152
on Accreditation in Physical Therapy attending and referring doctors of med-

Education (CAPTE); or icine or osteopathy.
(2) Meets both of the following: (g) If trained outside the United
(i) Graduated after successful com- States before January 1, 2008, meets
pletion of an education program deter- the following requirements:
mined to be substantially equivalent to (1) Was graduated since 1928 from a
physical therapist entry level edu- physical therapy curriculum approved
cation in the United States by a cre- in the country in which the curriculum
dentials evaluation organization ap- was located and in which there is a
proved by the American Physical Ther- member organization of the World Con-
apy Association or identified in 8 CFR federation for Physical Therapy.
212.15(e) as it relates to physical thera- (2) Meets the requirements for mem-
pists. bership in a member organization of
(ii) Passed an examination for phys- the World Confederation for Physical
ical therapists approved by the State Therapy.
in which physical therapy services are Physical therapist assistant. A person
provided. who is licensed, unless licensure does
(c) Before January 1, 2008— not apply, registered, or certified as a
(1) Graduated from a physical ther- physical therapist assistant, if applica-
apy curriculum approved by one of the ble, by the State in which practicing,
following: and meets one of the following require-
(i) The American Physical Therapy ments:
Association. (a)(1) Graduated from a physical
therapist assistant curriculum ap-
(ii) The Committee on Allied Health
proved by the Commission on Accredi-
Education and Accreditation of the
tation in Physical Therapy Education
American Medical Association.
of the American Physical Therapy As-
(iii) The Council on Medical Edu-
sociation; or if educated outside the
cation of the American Medical Asso-
United States or trained in the United
ciation and the American Physical
States military, graduated from an
Therapy Association.
education program determined to be
(d) On or before December 31, 1977 substantially equivalent to physical
was licensed or qualified as a physical therapist assistant entry level edu-
therapist and meets both of the fol- cation in the United States by a cre-
lowing: dentials evaluation organization ap-
(1) Has 2 years of appropriate experi- proved by the American Physical Ther-
ence as a physical therapist. apy Association or identified at 8 CFR
(2) Has achieved a satisfactory grade 212.15(e); and
on a proficiency examination con- (2) Passed a national examination for
ducted, approved, or sponsored by the physical therapist assistants.
U.S. Public Health Service. (b) On or before December 31, 2009,
(e) Before January 1, 1966— meets one of the following:
(1) Was admitted to membership by (1) Is licensed, or otherwise regulated
the American Physical Therapy Asso- in the State in which practicing.
ciation; or (2) In States where licensure or other
(2) Was admitted to registration by regulations do not apply, graduated on
the American Registry of Physical or before December 31, 2009, from a 2-
Therapists; or year college-level program approved by
(3) Has graduated from a physical the American Physical Therapy Asso-
therapy curriculum in a 4-year college ciation and, effective January 1, 2010
or university approved by a State de- meets the requirements of paragraph
partment of education. (a) of this definition.
(f) Before January 1, 1966 was li- (c) Before January 1, 2008, where li-
censed or registered, and before Janu- censure or other regulation does not
ary 1, 1970, had 15 years of full-time ex- apply, graduated from a 2-year college-
perience in the treatment of illness or level program approved by the Amer-
injury through the practice of physical ican Physical Therapy Association.

therapy in which services were ren- (d) On or before December 31, 1977,
dered under the order and direction of was licensed or qualified as a physical
153
Subpart A, Nt. 42 CFR Ch. IV (10–1–17 Edition)
therapist assistant and has achieved a (b) In the case of an individual who
satisfactory grade on a proficiency ex- furnishes services in a State which
amination conducted, approved, or does not license speech-language pa-
sponsored by the U.S. Public Health thologists:
Service. (1) Has successfully completed 350
Physician. A doctor of medicine, clock hours of supervised clinical
osteophathy or podiatry legally au- practicum (or is in the process of accu-
thorized to practice medicine and sur- mulating such supervised clinical expe-
gery by the State in which such func- rience);
tion or action is performed. (2) Performed not less than 9 months
Practical (vocational) nurse. A person of supervised full-time speech-language
who is licensed as a practical (voca- pathology services after obtaining a
tional) nurse by the State in which master’s or doctoral degree in speech-
practicing. language pathology or a related field;
Public health nurse. A registered and
nurse who has completed a bacca- (3) Successfully completed a national
laureate degree program approved by examination in speech-language pa-
the National League for Nursing for thology approved by the Secretary.
public health nursing preparation or [54 FR 33367, Aug. 14, 1989, as amended at 56
postregistered nurse study that in- FR 32973, July 18, 1991; 69 FR 66426, Nov. 15,
cludes content aproved by the National 2004; 72 FR 66406, Nov. 27, 2007; 73 FR 2433,
League for Nursing for public health Jan. 15, 2008; 79 FR 66118, Nov. 6, 2014]
nursing preparation. EFFECTIVE DATE NOTE: At 82 FR 4578, Jan.
Registered nurse (RN). A graduate of 13, 2017, subpart A was revised, effective July
an approved school of professional 13, 2017. At 82 FR 31729, July 10, 2017, this
nursing, who is licensed as a registered amendment was delayed until Jan. 13, 2018.
nurse by the State in which practicing. For the convenience of the user, the revised
Social work assistant. A person who: text is set forth as follows:
(1) Has a baccalaureate degree in so- Subpart A—General Provisions
cial work, psychology, sociology, or
other field related to social work, and § 484.1 Basis and scope.
has had at least 1 year of social work (a) Basis. This part is based on:
experience in a health care setting; or (1) Sections 1861(o) and 1891 of the Act,
(2) Has 2 years of appropriate experi- which establish the conditions that an HHA
ence as a social work assistant, and has must meet in order to participate in the
achieved a satisfactory grade on a pro- Medicare program and which, along with the
ficiency examination conducted, ap- additional requirements set forth in this
part, are considered necessary to ensure the
proved, or sponsored by the U.S. Public health and safety of patients; and
Health Service, except that these de- (2) Section 1861(z) of the Act, which speci-
terminations of proficiency do not fies the institutional planning standards
apply with respect to persons initially that HHAs must meet.
licensed by a State or seeking initial (b) Scope. The provisions of this part serve
qualification as a social work assistant as the basis for survey activities for the pur-
after December 31, 1977. pose of determining whether an agency
Social worker. A person who has a meets the requirements for participation in
the Medicare program.
master’s degree from a school of social
work accredited by the Council on So- § 484.2 Definitions.
cial Work Education, and has 1 year of As used in subparts A, B, and C, of this
social work experience in a health care part—
setting. Branch office means an approved location
Speech-language pathologist. A person or site from which a home health agency
who has a master’s or doctoral degree provides services within a portion of the
in speech-language pathology, and who total geographic area served by the parent
meets either of the following require- agency. The parent home health agency
must provide supervision and administrative
ments:
control of any branch office. It is unneces-

(a) Is licensed as a speech-language sary for the branch office to independently
pathologist by the State in which the meet the conditions of participation as a
individual furnishes such services; or home health agency.
154
Clinical note means a notation of a contact Subpart B—Administration
with a patient that is written, timed, and
dated, and which describes signs and symp- § 484.10 Condition of participation: Pa-
toms, treatment, drugs administered and the tient rights.
patient’s reaction or response, and any
changes in physical or emotional condition The patient has the right to be in-
during a given period of time. formed of his or her rights. The HHA
In advance means that HHA staff must must protect and promote the exercise
complete the task prior to performing any of these rights.
hands-on care or any patient education. (a) Standard: Notice of rights. (1) The
Parent home health agency means the agen- HHA must provide the patient with a
cy that provides direct support and adminis- written notice of the patient’s rights in
trative control of a branch.
advance of furnishing care to the pa-
Primary home health agency means the HHA
which accepts the initial referral of a pa-
tient or during the initial evaluation
tient, and which provides services directly to visit before the initiation of treatment.
the patient or via another health care pro- (2) The HHA must maintain docu-
vider under arrangements (as applicable). mentation showing that it has com-
Proprietary agency means a private, for- plied with the requirements of this sec-
profit agency. tion.
Public agency means an agency operated by (b) Standard: Exercise of rights and re-
a state or local government. spect for property and person. (1) The pa-
Quality indicator means a specific, valid, tient has the right to exercise his or
and reliable measure of access, care out- her rights as a patient of the HHA.
comes, or satisfaction, or a measure of a
process of care.
(2) The patient’s family or guardian
Representative means the patient’s legal may exercise the patient’s rights when
representative, such as a guardian, who the patient has been judged incom-
makes health-care decisions on the patient’s petent.
behalf, or a patient-selected representative (3) The patient has the right to have
who participates in making decisions related his or her property treated with re-
to the patient’s care or well-being, including spect.
but not limited to, a family member or an (4) The patient has the right to voice
advocate for the patient. The patient deter-
grievances regarding treatment or care
mines the role of the representative, to the
extent possible.
that is (or fails to be) furnished, or re-
Subdivision means a component of a multi-
garding the lack of respect for property
function health agency, such as the home by anyone who is furnishing services
care department of a hospital or the nursing on behalf of the HHA and must not be
division of a health department, which inde- subjected to discrimination or reprisal
pendently meets the conditions of participa- for doing so.
tion for HHAs. A subdivision that has branch (5) The HHA must investigate com-
offices is considered a parent agency. plaints made by a patient or the pa-
Summary report means the compilation of tient’s family or guardian regarding
the pertinent factors of a patient’s clinical treatment or care that is (or fails to
notes that is submitted to the patient’s phy-
be) furnished, or regarding the lack of
sician.
respect for the patient’s property by
Supervised practical training means training
in a practicum laboratory or other setting in
anyone furnishing services on behalf of
which the trainee demonstrates knowledge the HHA, and must document both the
while providing covered services to an indi- existence of the complaint and the res-
vidual under the direct supervision of either olution of the complaint.
a registered nurse or a licensed practical (c) Standard: Right to be informed and
nurse who is under the supervision of a reg- to participate in planning care and treat-
istered nurse. ment. (1) The patient has the right to
Verbal order means a physician order that be informed, in advance about the care
is spoken to appropriate personnel and later to be furnished, and of any changes in
put in writing for the purposes of docu- the care to be furnished.
menting as well as establishing or revising
(i) The HHA must advise the patient
the patient’s plan of care.

in advance of the disciplines that will
furnish care, and the frequency of vis-
its proposed to be furnished.
155
§ 484.11 42 CFR Ch. IV (10–1–17 Edition)
(ii) The HHA must advise the patient (f) Standard: Home health hotline. The
in advance of any change in the plan of patient has the right to be advised of
care before the change is made. the availability of the toll-free HHA
(2) The patient has the right to par- hotline in the State. When the agency
ticipate in the planning of the care. accepts the patient for treatment or
(i) The HHA must advise the patient care, the HHA must advise the patient
in advance of the right to participate in writing of the telephone number of
in planning the care or treatment and the home health hotline established by
in planning changes in the care or the State, the hours of its operation,
treatment. and that the purpose of the hotline is
(ii) The HHA complies with the re- to receive complaints or questions
quirements of subpart I of part 489 of about local HHAs. The patient also has
this chapter relating to maintaining the right to use this hotline to lodge
written policies and procedures regard- complaints concerning the implemen-
ing advance directives. The HHA must tation of the advance directives re-
inform and distribute written informa- quirements.
tion to the patient, in advance, con-
cerning its policies on advance direc- [54 FR 33367, Aug. 14, 1989, as amended at 56
FR 32973, July 18, 1991; 57 FR 8203, Mar. 6,
tives, including a description of appli-
1992; 60 FR 33293, June 27, 1995]
cable State law. The HHA may furnish
advance directives information to a pa- § 484.11 Condition of participation: Re-
tient at the time of the first home lease of patient identifiable OASIS
visit, as long as the information is fur- information.
nished before care is provided.
(d) Standard: Confidentiality of medical The HHA and agent acting on behalf
records. The patient has the right to of the HHA in accordance with a writ-
confidentiality of the clinical records ten contract must ensure the confiden-
maintained by the HHA. The HHA tiality of all patient identifiable infor-
must advise the patient of the agency’s mation contained in the clinical
policies and procedures regarding dis- record, including OASIS data, and may
closure of clinical records. not release patient identifiable OASIS
(e) Standard: Patient liability for pay- information to the public.
ment. (1) The patient has the right to [64 FR 3763, Jan. 25, 1999]
be advised, before care is initiated, of
the extent to which payment for the § 484.12 Condition of participation:
HHA services may be expected from Compliance with Federal, State,
Medicare or other sources, and the ex- and local laws, disclosure and own-
tent to which payment may be required ership information, and accepted
from the patient. Before the care is ini- professional standards and prin-
ciples.
tiated, the HHA must inform the pa-
tient, orally and in writing, of— (a) Standard: Compliance with Federal,
(i) The extent to which payment may State, and local laws and regulations.
be expected from Medicare, Medicaid, The HHA and its staff must operate
or any other Federally funded or aided and furnish services in compliance with
program known to the HHA; all applicable Federal, State, and local
(ii) The charges for services that will laws and regulations. If State or appli-
not be covered by Medicare; and cable local law provides for the licen-
(iii) The charges that the individual sure of HHAs, an agency not subject to
may have to pay. licensure is approved by the licensing
(2) The patient has the right to be ad- authority as meeting the standards es-
vised orally and in writing of any tablished for licensure.
changes in the information provided in (b) Standard: Disclosure of ownership
accordance with paragraph (e)(1) of this and management information. The HHA
section when they occur. The HHA must comply with the requirements of
must advise the patient of these part 420, Subpart C of this chapter. The
changes orally and in writing as soon HHA also must disclose the following
as possible, but no later than 30 cal- information to the State survey agency
endar days from the date that the HHA at the time of the HHA’s initial request
becomes aware of a change. for certification, for each survey, and
156
at the time of any change in ownership arrangements with another agency or

or management: organization.
(1) The name and address of all per- (b) Standard: Governing body. A gov-
sons with an ownership or control in- erning body (or designated persons so
terest in the HHA as defined in functioning) assumes full legal author-
§§ 420.201, 420.202, and 420.206 of this ity and responsibility for the operation
chapter. of the agency. The governing body ap-
(2) The name and address of each per- points a qualified administrator, ar-
son who is an officer, a director, an ranges for professional advice as re-
agent or a managing employee of the quired under § 484.16, adopts and peri-
HHA as defined in §§ 420.201, 420.202, and odically reviews written bylaws or an
420.206 of this chapter. acceptable equivalent, and oversees the
(3) The name and address of the cor- management and fiscal affairs of the
poration, association, or other com- agency.
pany that is responsible for the man- (c) Standard: Administrator. The ad-
agement of the HHA, and the name and ministrator, who may also be the su-
address of the chief executive officer pervising physician or registered nurse
and the chairman of the board of direc- required under paragraph (d) of this
tors of that corporation, association, section, organizes and directs the agen-
or other company responsible for the cy’s ongoing functions; maintains on-
management of the HHA. going liaison among the governing
(c) Standard: Compliance with accepted body, the group of professional per-
professional standards and principles. sonnel, and the staff; employs qualified
The HHA and its staff must comply personnel and ensures adequate staff
with accepted professional standards education and evaluations; ensures the
and principles that apply to profes- accuracy of public information mate-
sionals furnishing services in an HHA. rials and activities; and implements an
effective budgeting and accounting sys-
§ 484.14 Condition of participation: Or- tem. A qualified person is authorized in
ganization, services, and adminis- writing to act in the absence of the ad-
tration. ministrator.
Organization, services furnished, ad- (d) Standard: Supervising physician or
ministrative control, and lines of au- registered nurse. The skilled nursing and
thority for the delegation of responsi- other therapeutic services furnished
bility down to the patient care level are under the supervision and direction
are clearly set forth in writing and are of a physician or a registered nurse
readily identifiable. Administrative (who preferably has at least 1 year of
and supervisory functions are not dele- nursing experience and is a public
gated to another agency or organiza- health nurse). This person, or similarly
tion and all services not furnished di- qualified alternate, is available at all
rectly, including services provided times during operating hours and par-
through subunits are monitored and ticipates in all activities relevant to
controlled by the parent agency. If an the professional services furnished, in-
agency has subunits, appropriate ad- cluding the development of qualifica-
ministrative records are maintained tions and the assignment of personnel.
for each subunit. (e) Standard: Personnel policies. Per-
(a) Standard: Services furnished. Part- sonnel practices and patient care are
time or intermittent skilled nursing supported by appropriate, written per-
services and at least one other thera- sonnel policies. Personnel records in-
peutic service (physical, speech, or oc- clude qualifications and licensure that
cupational therapy; medical social are kept current.
services; or home health aide services) (f) Standard: Personnel under hourly or
are made available on a visiting basis, per visit contracts. If personnel under
in a place of residence used as a pa- hourly or per visit contracts are used
tient’s home. An HHA must provide at by the HHA, there is a written contract
least one of the qualifying services di- between those personnel and the agen-
rectly through agency employees, but cy that specifies the following:

may provide the second qualifying (1) Patients are accepted for care
service and additional services under only by the primary HHA.
157
§ 484.14 42 CFR Ch. IV (10–1–17 Edition)
(2) The services to be furnished. of more than $600,000 for items that
(3) The necessity to conform to all would under generally accepted ac-
applicable agency policies, including counting principles, be considered cap-
personnel qualifications. ital items. In determining if a single
(4) The responsibility for partici- capital expenditure exceeds $600,000,
pating in developing plans of care. the cost of studies, surveys, designs,
(5) The manner in which services will plans, working drawings, specifica-
be controlled, coordinated, and evalu- tions, and other activities essential to
ated by the primary HHA. the acquisition, improvement, mod-
(6) The procedures for submitting ernization, expansion, or replacement
clinical and progress notes, scheduling of land, plant, building, and equipment
of visits, periodic patient evaluation. are included. Expenditures directly or
(7) The procedures for payment for indirectly related to capital expendi-
services furnished under the contract. tures, such as grading, paving, broker
(g) Standard: Coordination of patient commissions, taxes assessed during the
services. All personnel furnishing serv- construction period, and costs involved
ices maintain liaison to ensure that in demolishing or razing structures on
their efforts are coordinated effectively land are also included. Transactions
and support the objectives outlined in that are separated in time, but are
the plan of care. The clinical record or components of an overall plan or pa-
minutes of case conferences establish tient care objective, are viewed in their
that effective interchange, reporting, entirety without regard to their tim-
and coordination of patient care does ing. Other costs related to capital ex-
occur. A written summary report for penditures include title fees, permit
each patient is sent to the attending and license fees, broker commissions,
physician at least every 60 days. architect, legal, accounting, and ap-
(h) Standard: Services under arrange- praisal fees; interest, finance, or car-
ments. Services furnished under ar- rying charges on bonds, notes and
rangements are subject to a written other costs incurred for borrowing
contract conforming with the require- funds.
ments specified in paragraph (f) of this (ii) If the anticipated source of fi-
section and with the requirements of nancing is, in any part, the anticipated
section 1861(w) of the Act (42 U.S.C. payment from title V (Maternal and
1495x(w)). Child Health and Crippled Children’s
(i) Standard: Institutional planning. Services) or title XVIII (Medicare) or
The HHA, under the direction of the title XIX (Medicaid) of the Social Secu-
governing body, prepares an overall rity Act, the plan specifies the fol-
plan and a budget that includes an an- lowing:
nual operating budget and capital ex- (A) Whether the proposed capital ex-
penditure plan. penditure is required to comform, or is
(1) Annual operating budget. There is likely to be required to conform, to
an annual operating budget that in- current standards, criteria, or plans de-
cludes all anticipated income and ex- veloped in accordance with the Public
penses related to items that would, Health Service Act or the Intellectual
under generally accepted accounting Disability Facilities and Community
principles, be considered income and Mental Health Centers Construction
expense items. However, it is not re- Act of 1963.
quired that there be prepared, in con- (B) Whether a capital expenditure
nection with any budget, an item by proposal has been submitted to the des-
item identification of the components ignated planning agency for approval
of each type of anticipated income or in accordance with section 1122 of the
expense. Act (42 U.S.C. 1320a–1) and imple-
(2) Capital expenditure plan. (i) There menting regulations.
is a capital expenditure plan for at (C) Whether the designated planning
least a 3-year period, including the op- agency has approved or disapproved the
erating budget year. The plan includes proposed capital expenditure if it was
and identifies in detail the anticipated presented to that agency.

sources of financing for, and the objec- (3) Preparation of plan and budget. The
tives of, each anticipated expenditure overall plan and budget is prepared
158
under the direction of the governing nity and in the agency’s community in-
body of the HHA by a committee con- formation program. The meetings are
sisting of representatives of the gov- documented by dated minutes.
erning body, the administrative staff,
[54 FR 33367, Aug. 14, 1989, as amended at 56
and the medical staff (if any) of the
FR 32974, July 18, 1991]
HHA.
(4) Annual review of plan and budget. § 484.18 Condition of participation: Ac-
The overall plan and budget is reviewed ceptance of patients, plan of care,
and updated at least annually by the and medical supervision.
committee referred to in paragraph
(i)(3) of this section under the direction Patients are accepted for treatment
of the governing body of the HHA. on the basis of a reasonable expecta-
(j) Standard: Laboratory services. (1) If tion that the patient’s medical, nurs-
the HHA engages in laboratory testing ing, and social needs can be met ade-
outside of the context of assisting an quately by the agency in the patient’s
individual in self-administering a test place of residence. Care follows a writ-
with an appliance that has been cleared ten plan of care established and peri-
for that purpose by the FDA, such test- odically reviewed by a doctor of medi-
ing must be in compliance with all ap- cine, osteopathy, or podiatric medi-
plicable requirements of part 493 of this cine.
chapter. (a) Standard: Plan of care. The plan of
(2) If the HHA chooses to refer speci- care developed in consultation with the
mens for laboratory testing to another agency staff covers all pertinent diag-
laboratory, the referral laboratory noses, including mental status, types
must be certified in the appropriate of services and equipment required, fre-
specialties and subspecialties of serv- quency of visits, prognosis, rehabilita-
ices in accordance with the applicable tion potential, functional limitations,
requirements of part 493 of this chap- activities permitted, nutritional re-
ter. quirements, medications and treat-
ments, any safety measures to protect
FR 32973, July 18, 1991; 56 FR 51334, Oct. 11,
against injury, instructions for timely
1991; 57 FR 7136, Feb. 28, 1992; 66 FR 32778, discharge or referral, and any other ap-
June 18, 2001] propriate items. If a physician refers a
patient under a plan of care that can-
§ 484.16 Condition of participation: not be completed until after an evalua-
Group of professional personnel. tion visit, the physician is consulted to
A group of professional personnel, approve additions or modifications to
which includes at least one physician the original plan. Orders for therapy
and one registered nurse (preferably a services include the specific procedures
public health nurse), and with appro- and modalities to be used and the
priate representation from other pro- amount, frequency, and duration. The
fessional disciplines, establishes and therapist and other agency personnel
annually reviews the agency’s policies participate in developing the plan of
governing scope of services offered, ad- care.
mission and discharge policies, medical (b) Standard: Periodic review of plan of
supervision and plans of care, emer- care. The total plan of care is reviewed
gency care, clinical records, personnel by the attending physician and HHA
qualifications, and program evalua- personnel as often as the severity of
tion. At least one member of the group the patient’s condition requires, but at
is neither an owner nor an employee of least once every 60 days or more fre-
the agency. quently when there is a beneficiary
(a) Standard: Advisory and evaluation elected transfer; a significant change
function. The group of professional per- in condition resulting in a change in
sonnel meets frequently to advise the the case-mix assignment; or a dis-
agency on professional issues, to par- charge and return to the same HHA
ticipate in the evaluation of the agen- during the 60-day episode. Agency pro-
cy’s program, and to assist the agency fessional staff promptly alert the phy-
in maintaining liaison with other sician to any changes that suggest a
health care providers in the commu- need to alter the plan of care.
159
§ 484.20 42 CFR Ch. IV (10–1–17 Edition)
(c) Standard: Conformance with physi- (4) Transmit data that includes the
cian orders. Drugs and treatments are CMS-assigned branch identification
administered by agency staff only as number, as applicable.
ordered by the physician with the ex- (d) Standard: Data Format. The HHA
ception of influenza and pneumococcal must encode and transmit data using
polysaccharide vaccines, which may be the software available from CMS or
administered per agency policy devel- software that conforms to CMS stand-
oped in consultation with a physician, ard electronic record layout, edit speci-
and after an assessment for contra- fications, and data dictionary, and that
indications. Verbal orders are put in includes the required OASIS data set.
writing and signed and dated with the [64 FR 3763, Jan. 25, 1999, as amended at 70
date of receipt by the registered nurse FR 76208, Dec. 23, 2005]
or qualified therapist (as defined in
§ 484.4 of this chapter) responsible for § 484.22 Condition of participation:
furnishing or supervising the ordered Emergency preparedness.
services. Verbal orders are only accept- The Home Health Agency (HHA)
ed by personnel authorized to do so by must comply with all applicable Fed-
applicable State and Federal laws and eral, State, and local emergency pre-
regulations as well as by the HHA’s in- paredness requirements. The HHA
ternal policies. must establish and maintain an emer-
[54 FR 33367, Aug. 14, 1989, as amended at 56 gency preparedness program that
FR 32974, July 18, 1991; 64 FR 3784, Jan. 25, meets the requirements of this section.
1999; 65 FR 41211, July 3, 2000; 67 FR 61814, The emergency preparedness program
Oct. 2, 2002] must include, but not be limited to, the
following elements:
§ 484.20 Condition of participation: Re- (a) Emergency plan. The HHA must
porting OASIS information. develop and maintain an emergency
HHAs must electronically report all preparedness plan that must be re-
OASIS data collected in accordance viewed, and updated at least annually.
with § 484.55. The plan must do all of the following:
(a) Standard: Encoding and transmit- (1) Be based on and include a docu-
ting OASIS data. An HHA must encode mented, facility-based and community-
and electronically transmit each com- based risk assessment, utilizing an all-
pleted OASIS assessment to the State hazards approach.
agency or the CMS OASIS contractor, (2) Include strategies for addressing
regarding each beneficiary with respect emergency events identified by the
to which such information is required risk assessment.
to be transmitted (as determined by (3) Address patient population, in-
the Secretary), within 30 days of com- cluding, but not limited to, the type of
pleting the assessment of the bene- services the HHA has the ability to
ficiary. provide in an emergency; and con-
(b) Standard: Accuracy of encoded tinuity of operations, including delega-
OASIS data. The encoded OASIS data tions of authority and succession
must accurately reflect the patient’s plans.
status at the time of assessment. (4) Include a process for cooperation
(c) Standard: Transmittal of OASIS and collaboration with local, tribal, re-
data. An HHA must— gional, State, and Federal emergency
(1) For all completed assessments, preparedness officials’ efforts to main-
transmit OASIS data in a format that tain an integrated response during a
meets the requirements of paragraph disaster or emergency situation, in-
(d) of this section. cluding documentation of the HHA’s ef-
(2) Successfully transmit test data to forts to contact such officials and,
the State agency or CMS OASIS con- when applicable, of its participation in
tractor. collaborative and cooperative planning
(3) Transmit data using electronics efforts.
communications software that provides (b) Policies and procedures. The HHA
a direct telephone connection from the must develop and implement emer-
HHA to the State agency or CMS gency preparedness policies and proce-
OASIS contractor. dures, based on the emergency plan set
160
forth in paragraph (a) of this section, (2) Contact information for the fol-
risk assessment at paragraph (a)(1) of lowing:
this section, and the communication (i) Federal, State, tribal, regional, or
plan at paragraph (c) of this section. local emergency preparedness staff.
The policies and procedures must be re- (ii) Other sources of assistance.
viewed and updated at least annually. (3) Primary and alternate means for
At a minimum, the policies and proce- communicating with the HHA’s staff,
dures must address the following: Federal, State, tribal, regional, and
(1) The plans for the HHA’s patients local emergency management agencies.
during a natural or man-made disaster. (4) A method for sharing information
Individual plans for each patient must and medical documentation for pa-
be included as part of the comprehen- tients under the HHA’s care, as nec-
sive patient assessment, which must be essary, with other health care pro-
conducted according to the provisions viders to maintain the continuity of
at § 484.55. care.
(2) The procedures to inform State (5) A means of providing information
and local emergency preparedness offi- about the general condition and loca-
cials about HHA patients in need of tion of patients under the facility’s
evacuation from their residences at care as permitted under 45 CFR
any time due to an emergency situa- 164.510(b)(4).
tion based on the patient’s medical and (6) A means of providing information
psychiatric condition and home envi- about the HHA’s needs, and its ability
ronment. to provide assistance, to the authority
(3) The procedures to follow up with having jurisdiction, the Incident Com-
on-duty staff and patients to determine mand Center, or designee.
services that are needed, in the event (d) Training and testing. The HHA
that there is an interruption in serv- must develop and maintain an emer-
ices during or due to an emergency. gency preparedness training and test-
The HHA must inform State and local ing program that is based on the emer-
officials of any on-duty staff or pa- gency plan set forth in paragraph (a) of
tients that they are unable to contact. this section, risk assessment at para-
(4) A system of medical documenta- graph (a)(1) of this section, policies and
tion that preserves patient informa- procedures at paragraph (b) of this sec-
tion, protects confidentiality of patient tion, and the communication plan at
information, and secures and main- paragraph (c) of this section. The train-
tains the availability of records. ing and testing program must be re-
viewed and updated at least annually.
(5) The use of volunteers in an emer-
(1) Training program. The HHA must
gency or other emergency staffing
do all of the following:
strategies, including the process and
(i) Initial training in emergency pre-
role for integration of State or Feder-
paredness policies and procedures to all
ally designated health care profes-
new and existing staff, individuals pro-
sionals to address surge needs during
viding services under arrangement, and
an emergency.
volunteers, consistent with their ex-
(c) Communication plan. The HHA pected roles.
must develop and maintain an emer- (ii) Provide emergency preparedness
gency preparedness communication training at least annually.
plan that complies with Federal, State, (iii) Maintain documentation of the
and local laws and must be reviewed training.
and updated at least annually. The (iv) Demonstrate staff knowledge of
communication plan must include all emergency procedures.
of the following: (2) Testing. The HHA must conduct
(1) Names and contact information exercises to test the emergency plan at
for the following: least annually. The HHA must do the
(i) Staff. following:
(ii) Entities providing services under (i) Participate in a full-scale exercise
arrangement. that is community-based or when a

(iii) Patients’ physicians. community-based exercise is not acces-
(iv) Volunteers. sible, an individual, facility-based. If
161
Subpart B, Nt. 42 CFR Ch. IV (10–1–17 Edition)
the HHA experiences an actual natural (i) A documented community-based

or man-made emergency that requires risk assessment, utilizing an all-haz-
activation of the emergency plan, the ards approach.
HHA is exempt from engaging in a (ii) A documented individual facility-
community-based or individual, facil- based risk assessment for each sepa-
ity-based full-scale exercise for 1 year rately certified facility within the
following the onset of the actual event. health system, utilizing an all-hazards
(ii) Conduct an additional exercise approach.
that may include, but is not limited to (5) Include integrated policies and
the following: procedures that meet the requirements
(A) A second full-scale exercise that set forth in paragraph (b) of this sec-
is community-based or individual, fa- tion, a coordinated communication
cility-based. plan and training and testing programs
(B) A tabletop exercise that includes that meet the requirements of para-
a group discussion led by a facilitator, graphs (c) and (d) of this section, re-
using a narrated, clinically-relevant spectively.
emergency scenario, and a set of prob-
[81 FR 64033, Sept. 16, 2016; 81 FR 80594, Nov.
lem statements, directed messages, or 16, 2016]
prepared questions designed to chal-
lenge an emergency plan. EFFECTIVE DATE NOTE: At 82 FR 4578, Jan.
(iii) Analyze the HHA’s response to 13, 2017, subpart B was revised, effective July
13, 2017. At 82 FR 31732, July 10, 2017, this
and maintain documentation of all
amendment was corrected. At 82 FR 31729,
drills, tabletop exercises, and emer- July 10, 2010, this amendment was delayed
gency events, and revise the HHA’s until Jan. 13, 2018. For the convenience of the
emergency plan, as needed. user, the revised text is set forth as follows:
(e) Integrated healthcare systems. If a
HHA is part of a healthcare system Subpart B—Patient Care
consisting of multiple separately cer-
§ 484.40 Condition of participation: Release
tified healthcare facilities that elects of patient identifiable OASIS information.
to have a unified and integrated emer-
The HHA and agent acting on behalf of the
gency preparedness program, the HHA HHA in accordance with a written contract
may choose to participate in the must ensure the confidentiality of all pa-
healthcare system’s coordinated emer- tient identifiable information contained in
gency preparedness program. If elected, the clinical record, including OASIS data,
the unified and integrated emergency and may not release patient identifiable
preparedness program must do all of OASIS information to the public.
the following: § 484.45 Condition of participation: Report-
(1) Demonstrate that each separately ing OASIS information.
certified facility within the system ac- HHAs must electronically report all OASIS
tively participated in the development data collected in accordance with § 484.55.
of the unified and integrated emer- (a) Standard: Encoding and transmitting
gency preparedness program. OASIS data. An HHA must encode and elec-
(2) Be developed and maintained in a tronically transmit each completed OASIS
manner that takes into account each assessment to the CMS system, regarding
separately certified facility’s unique each beneficiary with respect to which infor-
mation is required to be transmitted (as de-
termined by the Secretary), within 30 days of
and services offered. completing the assessment of the bene-
(3) Demonstrate that each separately ficiary.
certified facility is capable of actively (b) Standard: Accuracy of encoded OASIS
using the unified and integrated emer- data. The encoded OASIS data must accu-
gency preparedness program and is in rately reflect the patient’s status at the
compliance with the program. time of assessment.
(4) Include a unified and integrated (c) Standard: Transmittal of OASIS data. An
emergency plan that meets the require- HHA must—
(1) For all completed assessments, trans-
ments of paragraphs (a)(2), (3), and (4) mit OASIS data in a format that meets the
of this section. The unified and inte-
requirements of paragraph (d) of this section.

grated emergency plan must also be (2) Successfully transmit test data to the
based on and include all of the fol- QIES ASAP System or CMS OASIS con-
lowing: tractor.
162
Centers for Medicare & Medicaid Services, HHS Subpart B, Nt.
(3) Transmit data using electronic commu- lished by state law by a court of proper juris-
nications software that complies with the diction, the rights of the patient may be ex-
Federal Information Processing Standard ercised by the person appointed by the state
(FIPS 140–2, issued May 25, 2001) from the court to act on the patient’s behalf.
HHA or the HHA contractor to the CMS col- (2) If a state court has not adjudged a pa-
lection site. tient to lack legal capacity to make health
(4) Transmit data that includes the CMS- care decisions as defined by state law, the
assigned branch identification number, as patient’s representative may exercise the pa-
applicable. tient’s rights.
(d) Standard: Data Format. The HHA must (3) If a patient has been adjudged to lack
encode and transmit data using the software legal capacity to make health care decisions
available from CMS or software that con- under state law by a court of proper jurisdic-
forms to CMS standard electronic record lay- tion, the patient may exercise his or her
out, edit specifications, and data dictionary, rights to the extent allowed by court order.
and that includes the required OASIS data (c) Standard: Rights of the patient. The pa-
set. tient has the right to—
(1) Have his or her property and person
§ 484.50 Condition of participation: Patient treated with respect;
rights. (2) Be free from verbal, mental, sexual, and
The patient and representative (if any), physical abuse, including injuries of un-
have the right to be informed of the patient’s known source, neglect and misappropriation
rights in a language and manner the indi- of property;
vidual understands. The HHA must protect (3) Make complaints to the HHA regarding
and promote the exercise of these rights. treatment or care that is (or fails to be) fur-
(a) Standard: Notice of rights. The HHA nished, and the lack of respect for property
must— and/or person by anyone who is furnishing
(1) Provide the patient and the patient’s services on behalf of the HHA;
legal representative (if any), the following (4) Participate in, be informed about, and
information during the initial evaluation consent or refuse care in advance of and dur-
visit, in advance of furnishing care to the pa- ing treatment, where appropriate, with re-
tient: spect to—
(i) Written notice of the patient’s rights (i) Completion of all assessments;
and responsibilities under this rule, and the (ii) The care to be furnished, based on the
HHA’s transfer and discharge policies as set comprehensive assessment;
forth in paragraph (d) of this section. Writ- (iii) Establishing and revising the plan of
ten notice must be understandable to per- care;
sons who have limited English proficiency (iv) The disciplines that will furnish the
and accessible to individuals with disabil- care;
ities; (v) The frequency of visits;
(ii) Contact information for the HHA ad- (vi) Expected outcomes of care, including
ministrator, including the administrator’s patient-identified goals, and anticipated
name, business address, and business phone risks and benefits;
number in order to receive complaints. (vii) Any factors that could impact treat-
(iii) An OASIS privacy notice to all pa- ment effectiveness; and
tients for whom the OASIS data is collected. (viii) Any changes in the care to be fur-
(2) Obtain the patient’s or legal representa- nished.
tive’s signature confirming that he or she (5) Receive all services outlined in the plan
has received a copy of the notice of rights of care.
and responsibilities. (6) Have a confidential clinical record. Ac-
(3) Provide verbal notice of the patient’s cess to or release of patient information and
rights and responsibilities in the individual’s clinical records is permitted in accordance
primary or preferred language and in a man- with 45 CFR parts 160 and 164.
ner the individual understands, free of (7) Be advised of—
charge, with the use of a competent inter- (i) The extent to which payment for HHA
preter if necessary, no later than the comple- services may be expected from Medicare,
tion of the second visit from a skilled profes- Medicaid, or any other federally-funded or
sional as described in § 484.75. federal aid program known to the HHA,
(4) Provide written notice of the patient’s (ii) The charges for services that may not
rights and responsibilities under this rule be covered by Medicare, Medicaid, or any
and the HHA’s transfer and discharge poli- other federally-funded or federal aid program
cies as set forth in paragraph (d) of this sec- known to the HHA,
tion to a patient-selected representative (iii) The charges the individual may have
within 4 business days of the initial evalua- to pay before care is initiated; and
tion visit. (iv) Any changes in the information pro-

(b) Standard: Exercise of rights. (1) If a pa- vided in accordance with paragraph (c)(7) of
tient has been adjudged to lack legal capac- this section when they occur. The HHA must
ity to make health care decisions as estab- advise the patient and representative (if
163
any), of these changes as soon as possible, in ments of paragraphs (d)(5)(i) through
advance of the next home health visit. The (d)(5)(iii) of this section, that the patient’s
HHA must comply with the patient notice (or other persons in the patient’s home) be-
requirements at 42 CFR 411.408(d)(2) and 42 havior is disruptive, abusive, or uncoopera-
CFR 411.408(f). tive to the extent that delivery of care to the
(8) Receive proper written notice, in ad- patient or the ability of the HHA to operate
vance of a specific service being furnished, if effectively is seriously impaired. The HHA
the HHA believes that the service may be must do the following before it discharges a
non-covered care; or in advance of the HHA patient for cause:
reducing or terminating on-going care. The (i) Advise the patient, representative (if
HHA must also comply with the require- any), the physician(s) issuing orders for the
ments of 42 CFR 405.1200 through 405.1204. home health plan of care, and the patient’s
(9) Be advised of the state toll free home primary care practitioner or other health
health telephone hot line, its contact infor- care professional who will be responsible for
mation, its hours of operation, and that its providing care and services to the patient
purpose is to receive complaints or questions after discharge from the HHA (if any) that a
about local HHAs. discharge for cause is being considered;
(10) Be advised of the names, addresses, and (ii) Make efforts to resolve the problem(s)
telephone numbers of the following Feder- presented by the patient’s behavior, the be-
ally-funded and state-funded entities that havior of other persons in the patient’s
serve the area where the patient resides: home, or situation;
(i) Agency on Aging, (iii) Provide the patient and representative
(ii) Center for Independent Living,
(if any), with contact information for other
(iii) Protection and Advocacy Agency,
agencies or providers who may be able to
(iv) Aging and Disability Resource Center;
provide care; and
and
(iv) Document the problem(s) and efforts
(v) Quality Improvement Organization.
(11) Be free from any discrimination or re- made to resolve the problem(s), and enter
prisal for exercising his or her rights or for this documentation into its clinical records;
voicing grievances to the HHA or an outside (6) The patient dies; or
entity. (7) The HHA ceases to operate.
(12) Be informed of the right to access aux- (e) Standard: Investigation of complaints. (1)
iliary aids and language services as described The HHA must—
in paragraph (f) of this section, and how to (i) Investigate complaints made by a pa-
access these services. tient, the patient’s representative (if any),
(d) Standard: Transfer and discharge. The and the patient’s caregivers and family, in-
patient and representative (if any), have a cluding, but not limited to, the following
right to be informed of the HHA’s policies for topics:
transfer and discharge. The HHA may only (A) Treatment or care that is (or fails to
transfer or discharge the patient from the be) furnished, is furnished inconsistently, or
HHA if: is furnished inappropriately; and
(1) The transfer or discharge is necessary (B) Mistreatment, neglect, or verbal, men-
for the patient’s welfare because the HHA tal, sexual, and physical abuse, including in-
and the physician who is responsible for the juries of unknown source, and/or misappro-
home health plan of care agree that the HHA priation of patient property by anyone fur-
can no longer meet the patient’s needs, based nishing services on behalf of the HHA.
on the patient’s acuity. The HHA must ar- (ii) Document both the existence of the
range a safe and appropriate transfer to complaint and the resolution of the com-
other care entities when the needs of the pa- plaint; and
tient exceed the HHA’s capabilities; (iii) Take action to prevent further poten-
(2) The patient or payer will no longer pay tial violations, including retaliation, while
for the services provided by the HHA; the complaint is being investigated.
(3) The transfer or discharge is appropriate (2) Any HHA staff (whether employed di-
because the physician who is responsible for rectly or under arrangements) in the normal
the home health plan of care and the HHA course of providing services to patients, who
agree that the measurable outcomes and identifies, notices, or recognizes incidences
goals set forth in the plan of care in accord- or circumstances of mistreatment, neglect,
ance with § 484.60(a)(2)(xiv) have been verbal, mental, sexual, and/or physical
achieved, and the HHA and the physician abuse, including injuries of unknown source,
who is responsible for the home health plan or misappropriation of patient property,
of care agree that the patient no longer must report these findings immediately to
needs the HHA’s services; the HHA and other appropriate authorities
(4) The patient refuses services, or elects to in accordance with state law.
be transferred or discharged; (f) Standard: Accessibility. Information must

(5) The HHA determines, under a policy set be provided to patients in plain language and
by the HHA for the purpose of addressing dis- in a manner that is accessible and timely
charge for cause that meets the require- to—
164
(1) Persons with disabilities, including ac- (c) Standard: Content of the comprehensive
cessible Web sites and the provision of auxil- assessment. The comprehensive assessment
iary aids and services at no cost to the indi- must accurately reflect the patient’s status,
vidual in accordance with the Americans and must include, at a minimum, the fol-
with Disabilities Act and Section 504 of the lowing information:
Rehabilitation Act. (1) The patient’s current health, psycho-
(2) Persons with limited English pro- social, functional, and cognitive status;
ficiency through the provision of language (2) The patient’s strengths, goals, and care
services at no cost to the individual, includ- preferences, including information that may
ing oral interpretation and written trans- be used to demonstrate the patient’s
lations. progress toward achievement of the goals
identified by the patient and the measurable
§ 484.55 Condition of participation: Com- outcomes identified by the HHA;
prehensive assessment of patients. (3) The patient’s continuing need for home
Each patient must receive, and an HHA care;
must provide, a patient-specific, comprehen- (4) The patient’s medical, nursing, reha-
sive assessment. For Medicare beneficiaries, bilitative, social, and discharge planning
the HHA must verify the patient’s eligibility needs;
for the Medicare home health benefit includ- (5) A review of all medications the patient
ing homebound status, both at the time of is currently using in order to identify any
the initial assessment visit and at the time potential adverse effects and drug reactions,
of the comprehensive assessment. including ineffective drug therapy, signifi-
cant side effects, significant drug inter-
(a) Standard: Initial assessment visit. (1) A
actions, duplicate drug therapy, and non-
registered nurse must conduct an initial as-
compliance with drug therapy.
sessment visit to determine the immediate
(6) The patient’s primary caregiver(s), if
care and support needs of the patient; and,
any, and other available supports, including
for Medicare patients, to determine eligi-
their:
bility for the Medicare home health benefit,
(i) Willingness and ability to provide care,
including homebound status. The initial as-
and
sessment visit must be held either within 48
(ii) Availability and schedules;
hours of referral, or within 48 hours of the (7) The patient’s representative (if any);
patient’s return home, or on the physician- (8) Incorporation of the current version of
ordered start of care date. the Outcome and Assessment Information
(2) When rehabilitation therapy service Set (OASIS) items, using the language and
(speech language pathology, physical ther- groupings of the OASIS items, as specified
apy, or occupational therapy) is the only by the Secretary. The OASIS data items de-
service ordered by the physician who is re- termined by the Secretary must include:
sponsible for the home health plan of care, clinical record items, demographics and pa-
and if the need for that service establishes tient history, living arrangements, sup-
program eligibility, the initial assessment portive assistance, sensory status,
visit may be made by the appropriate reha- integumentary status, respiratory status,
bilitation skilled professional. elimination status, neuro/emotional/behav-
(b) Standard: Completion of the comprehen- ioral status, activities of daily living, medi-
sive assessment. (1) The comprehensive assess- cations, equipment management, emergent
ment must be completed in a timely manner, care, and data items collected at inpatient
consistent with the patient’s immediate facility admission or discharge only.
needs, but no later than 5 calendar days after (d) Standard: Update of the comprehensive as-
the start of care. sessment. The comprehensive assessment
(2) Except as provided in paragraph (b)(3) of must be updated and revised (including the
this section, a registered nurse must com- administration of the OASIS) as frequently
plete the comprehensive assessment and for as the patient’s condition warrants due to a
Medicare patients, determine eligibility for major decline or improvement in the pa-
the Medicare home health benefit, including tient’s health status, but not less frequently
homebound status. than—
(3) When physical therapy, speech-lan- (1) The last 5 days of every 60 days begin-
guage pathology, or occupational therapy is ning with the start-of-care date, unless there
the only service ordered by the physician, a is a—
physical therapist, speech-language patholo- (i) Beneficiary elected transfer;
gist or occupational therapist may complete (ii) Significant change in condition; or
the comprehensive assessment, and for Medi- (iii) Discharge and return to the same HHA
care patients, determine eligibility for the during the 60-day episode.
Medicare home health benefit, including (2) Within 48 hours of the patient’s return
homebound status. The occupational thera- to the home from a hospital admission of 24
pist may complete the comprehensive assess- hours or more for any reason other than di-
ment if the need for occupational therapy es- agnostic tests, or on physician-ordered re-
tablishes program eligibility. sumption date;
165
(3) At discharge. (xvi) Any additional items the HHA or phy-
sician may choose to include.
§ 484.60 Condition of participation: Care (3) All patient care orders, including verbal
planning, coordination of services, and orders, must be recorded in the plan of care.
quality of care. (b) Standard: Conformance with physician or-
Patients are accepted for treatment on the ders. (1) Drugs, services, and treatments are
reasonable expectation that an HHA can administered only as ordered by a physician.
meet the patient’s medical, nursing, reha- (2) Influenza and pneumococcal vaccines
bilitative, and social needs in his or her may be administered per agency policy de-
place of residence. Each patient must receive veloped in consultation with a physician,
an individualized written plan of care, in- and after an assessment of the patient to de-
cluding any revisions or additions. The indi- termine for contraindications.
vidualized plan of care must specify the care (3) Verbal orders must be accepted only by
and services necessary to meet the patient- personnel authorized to do so by applicable
specific needs as identified in the com- state laws and regulations and by the HHA’s
prehensive assessment, including identifica- internal policies.
tion of the responsible discipline(s), and the (4) When services are provided on the basis
measurable outcomes that the HHA antici- of a physician’s verbal orders, a nurse acting
pates will occur as a result of implementing in accordance with state licensure require-
and coordinating the plan of care. The indi- ments, or other qualified practitioner re-
vidualized plan of care must also specify the sponsible for furnishing or supervising the
patient and caregiver education and train- ordered services, in accordance with state
ing. Services must be furnished in accord- law and the HHA’s policies, must document
ance with accepted standards of practice. the orders in the patient’s clinical record,
(a) Standard: Plan of care. (1) Each patient and sign, date, and time the orders. Verbal
must receive the home health services that orders must be authenticated and dated by
are written in an individualized plan of care the physician in accordance with applicable
that identifies patient-specific measurable state laws and regulations, as well as the
outcomes and goals, and which is estab- HHA’s internal policies.
lished, periodically reviewed, and signed by a (c) Standard: Review and revision of the plan
doctor of medicine, osteopathy, or podiatry of care. (1) The individualized plan of care
acting within the scope of his or her state li- must be reviewed and revised by the physi-
cense, certification, or registration. If a phy- cian who is responsible for the home health
sician refers a patient under a plan of care plan of care and the HHA as frequently as
that cannot be completed until after an eval- the patient’s condition or needs require, but
uation visit, the physician is consulted to no less frequently than once every 60 days,
approve additions or modifications to the beginning with the start of care date. The
original plan. HHA must promptly alert the relevant phy-
(2) The individualized plan of care must in- sician(s) to any changes in the patient’s con-
clude the following: dition or needs that suggest that outcomes
(i) All pertinent diagnoses; are not being achieved and/or that the plan
of care should be altered.
(ii) The patient’s mental, psychosocial, and
(2) A revised plan of care must reflect cur-
cognitive status;
rent information from the patient’s updated
(iii) The types of services, supplies, and
comprehensive assessment, and contain in-
equipment required;
formation concerning the patient’s progress
(iv) The frequency and duration of visits to toward the measurable outcomes and goals
be made; identified by the HHA and patient in the
(v) Prognosis; plan of care.
(vi) Rehabilitation potential; (3) Revisions to the plan of care must be
(vii) Functional limitations; communicated as follows:
(viii) Activities permitted; (i) Any revision to the plan of care due to
(ix) Nutritional requirements; a change in patient health status must be
(x) All medications and treatments; communicated to the patient, representative
(xi) Safety measures to protect against in- (if any), caregiver, and all physicians issuing
jury; orders for the HHA plan of care.
(xii) A description of the patient’s risk for (ii) Any revisions related to plans for the
emergency department visits and hospital patient’s discharge must be communicated
re-admission, and all necessary interven- to the patient, representative, caregiver, all
tions to address the underlying risk factors. physicians issuing orders for the HHA plan of
(xiii) Patient and caregiver education and care, and the patient’s primary care practi-
training to facilitate timely discharge; tioner or other health care professional who
(xiv) Patient-specific interventions and will be responsible for providing care and
education; measurable outcomes and goals services to the patient after discharge from
identified by the HHA and the patient; the HHA (if any).
(xv) Information related to any advanced (d) Standard: Coordination of care. The HHA
directives; and must:
166
(1) Assure communication with all physi- (a) Standard: Program scope. (1) The pro-
cians involved in the plan of care. gram must at least be capable of showing
(2) Integrate orders from all physicians in- measurable improvement in indicators for
volved in the plan of care to assure the co- which there is evidence that improvement in
ordination of all services and interventions those indicators will improve health out-
provided to the patient. comes, patient safety, and quality of care.
(3) Integrate services, whether services are (2) The HHA must measure, analyze, and
provided directly or under arrangement, to track quality indicators, including adverse
assure the identification of patient needs and patient events, and other aspects of perform-
factors that could affect patient safety and ance that enable the HHA to assess processes
treatment effectiveness and the coordination of care, HHA services, and operations.
of care provided by all disciplines. (b) Standard: Program data. (1) The program
(4) Coordinate care delivery to meet the must utilize quality indicator data, includ-
patient’s needs, and involve the patient, rep- ing measures derived from OASIS, where ap-
resentative (if any), and caregiver(s), as applicable, and other relevant data, in the de-
propriate, in the coordination of care activi- sign of its program.
ties. (2) The HHA must use the data collected
to—
(5) Ensure that each patient, and his or her
(i) Monitor the effectiveness and safety of
caregiver(s) where applicable, receive ongo-
services and quality of care; and
ing education and training provided by the
(ii) Identify opportunities for improve-
HHA, as appropriate, regarding the care and
ment.
services identified in the plan of care. The
(3) The frequency and detail of the data
HHA must provide training, as necessary, to
collection must be approved by the HHA’s
ensure a timely discharge.
governing body.
(e) Standard: Written information to the pa- (c) Standard: Program activities. (1) The
tient. The HHA must provide the patient and HHA’s performance improvement activities
caregiver with a copy of written instructions must—
outlining: (i) Focus on high risk, high volume, or
(1) Visit schedule, including frequency of problem-prone areas;
visits by HHA personnel and personnel act- (ii) Consider incidence, prevalence, and se-
ing on behalf of the HHA. verity of problems in those areas; and
(2) Patient medication schedule/instruc- (iii) Lead to an immediate correction of
tions, including: medication name, dosage any identified problem that directly or po-
and frequency and which medications will be tentially threaten the health and safety of
administered by HHA personnel and per- patients.
sonnel acting on behalf of the HHA. (2) Performance improvement activities
(3) Any treatments to be administered by must track adverse patient events, analyze
HHA personnel and personnel acting on be- their causes, and implement preventive ac-
half of the HHA, including therapy services. tions.
(4) Any other pertinent instruction related (3) The HHA must take actions aimed at
to the patient’s care and treatments that the performance improvement, and, after imple-
HHA will provide, specific to the patient’s menting those actions, the HHA must meas-
care needs. ure its success and track performance to en-
(5) Name and contact information of the sure that improvements are sustained.
HHA clinical manager. (d) Standard: Performance improvement
projects. Beginning July 13, 2018 HHAs must
§ 484.65 Condition of participation: Quality conduct performance improvement projects.
assessment and performance improve- (1) The number and scope of distinct im-
ment (QAPI). provement projects conducted annually must
The HHA must develop, implement, evalu- reflect the scope, complexity, and past per-
ate, and maintain an effective, ongoing, formance of the HHA’s services and oper-
HHA-wide, data-driven QAPI program. The ations.
HHA’s governing body must ensure that the (2) The HHA must document the quality
program reflects the complexity of its orga- improvement projects undertaken, the rea-
nization and services; involves all HHA serv- sons for conducting these projects, and the
ices (including those services provided under measurable progress achieved on these
contract or arrangement); focuses on indica- projects.
tors related to improved outcomes, including (e) Standard: Executive responsibilities. The
the use of emergent care services, hospital HHA’s governing body is responsible for en-
admissions and re-admissions; and takes ac- suring the following:
tions that address the HHA’s performance (1) That an ongoing program for quality
across the spectrum of care, including the improvement and patient safety is defined,
prevention and reduction of medical errors. implemented, and maintained;

The HHA must maintain documentary evi- (2) That the HHA-wide quality assessment
dence of its QAPI program and be able to and performance improvement efforts ad-
demonstrate its operation to CMS. dress priorities for improved quality of care
167
and patient safety, and that all improvement (4) Patient, caregiver, and family coun-
actions are evaluated for effectiveness; seling;
(3) That clear expectations for patient (5) Patient and caregiver education;
safety are established, implemented, and (6) Preparing clinical notes;
maintained; and (7) Communication with all physicians in-
(4) That any findings of fraud or waste are volved in the plan of care and other health
appropriately addressed. care practitioners (as appropriate) related to
the current plan of care;
§ 484.70 Condition of participation: Infec- (8) Participation in the HHA’s QAPI pro-
tion prevention and control. gram; and
The HHA must maintain and document an (9) Participation in HHA-sponsored in-serv-
infection control program which has as its ice training.
goal the prevention and control of infections (c) Supervision of skilled professional assist-
and communicable diseases. ants. (1) Nursing services are provided under
(a) Standard: Prevention. The HHA must fol- the supervision of a registered nurse that
low accepted standards of practice, including meets the requirements of § 484.115(k).
the use of standard precautions, to prevent (2) Rehabilitative therapy services are pro-
the transmission of infections and commu- vided under the supervision of an occupa-
nicable diseases. tional therapist or physical therapist that
(b) Standard: Control. The HHA must main- meets the requirements of § 484.115(f) or (h),
tain a coordinated agency-wide program for respectively.
the surveillance, identification, prevention, (3) Medical social services are provided
control, and investigation of infectious and under the supervision of a social worker that
communicable diseases that is an integral meets the requirements of § 484.115(m).
part of the HHA’s quality assessment and
performance improvement (QAPI) program. § 484.80 Condition of participation: Home
The infection control program must include: health aide services.
(1) A method for identifying infectious and All home health aide services must be pro-
communicable disease problems; and vided by individuals who meet the personnel
(2) A plan for the appropriate actions that requirements specified in paragraph (a) of
are expected to result in improvement and this section.
disease prevention. (a) Standard: Home health aide qualifica-
(c) Standard: Education. The HHA must pro- tions. (1) A qualified home health aide is a
vide infection control education to staff, pa- person who has successfully completed:
tients, and caregiver(s). (i) A training and competency evaluation
program as specified in paragraphs (b) and
§ 484.75 Condition of participation: Skilled (c) respectively of this section; or
professional services. (ii) A competency evaluation program that
Skilled professional services include meets the requirements of paragraph (c) of
skilled nursing services, physical therapy, this section; or
speech-language pathology services, and oc- (iii) A nurse aide training and competency
cupational therapy, as specified in § 409.44 of evaluation program approved by the state as
this chapter, and physician and medical so- meeting the requirements of § 483.151 through
cial work services as specified in § 409.45 of § 483.154 of this chapter, and is currently list-
this chapter. Skilled professionals who pro- ed in good standing on the state nurse aide
vide services to HHA patients directly or registry; or
under arrangement must participate in the (iv) The requirements of a state licensure
coordination of care. program that meets the provisions of para-
(a) Standard: Provision of services by skilled graphs (b) and (c) of this section.
professionals. Skilled professional services (2) A home health aide or nurse aide is not
are authorized, delivered, and supervised considered to have completed a program, as
only by health care professionals who meet specified in paragraph (a)(1) of this section,
the appropriate qualifications specified if, since the individual’s most recent comple-
under § 484.115 and who practice according to tion of the program(s), there has been a con-
the HHA’s policies and procedures. tinuous period of 24 consecutive months dur-
(b) Standard: Responsibilities of skilled pro- ing which none of the services furnished by
fessionals. Skilled professionals must assume the individual as described in § 409.40 of this
responsibility for, but not be restricted to, chapter were for compensation. If there has
the following: been a 24-month lapse in furnishing services
(1) Ongoing interdisciplinary assessment of for compensation, the individual must com-
the patient; plete another program, as specified in para-
(2) Development and evaluation of the plan graph (a)(1) of this section, before providing
of care in partnership with the patient, rep- services.
resentative (if any), and caregiver(s); (b) Standard: Content and duration of home
(3) Providing services that are ordered by health aide classroom and supervised practical
the physician as indicated in the plan of training. (1) Home health aide training must
care; include classroom and supervised practical
168
training in a practicum laboratory or other (c) Standard: Competency evaluation. An in-
setting in which the trainee demonstrates dividual may furnish home health services
knowledge while providing services to an in- on behalf of an HHA only after that indi-
dividual under the direct supervision of a vidual has successfully completed a com-
registered nurse, or a licensed practical petency evaluation program as described in
nurse who is under the supervision of a reg- this section.
istered nurse. Classroom and supervised (1) The competency evaluation must ad-
practical training must total at least 75 dress each of the subjects listed in paragraph
hours. (b)(3) of this section. Subject areas specified
(2) A minimum of 16 hours of classroom under paragraphs (b)(3)(i), (iii), (ix), (x), and
training must precede a minimum of 16 (xi) of this section must be evaluated by ob-
hours of supervised practical training as part serving an aide’s performance of the task
of the 75 hours. with a patient. The remaining subject areas
(3) A home health aide training program may be evaluated through written examina-
must address each of the following subject tion, oral examination, or after observation
areas: of a home health aide with a patient.
(i) Communication skills, including the (2) A home health aide competency evalua-
ability to read, write, and verbally report tion program may be offered by any organi-
clinical information to patients, representa- zation, except as specified in paragraph (f) of
tives, and caregivers, as well as to other this section.
HHA staff. (3) The competency evaluation must be
(ii) Observation, reporting, and docu- performed by a registered nurse in consulta-
mentation of patient status and the care or tion with other skilled professionals, as ap-
service furnished. propriate.
(iii) Reading and recording temperature, (4) A home health aide is not considered
pulse, and respiration. competent in any task for which he or she is
(iv) Basic infection prevention and control evaluated as unsatisfactory. An aide must
procedures. not perform that task without direct super-
(v) Basic elements of body functioning and vision by a registered nurse until after he or
changes in body function that must be re- she has received training in the task for
ported to an aide’s supervisor. which he or she was evaluated as ‘‘unsatis-
(vi) Maintenance of a clean, safe, and factory,’’ and has successfully completed a
healthy environment. subsequent evaluation. A home health aide is
(vii) Recognizing emergencies and the not considered to have successfully passed a
knowledge of instituting emergency proce- competency evaluation if the aide has an
dures and their application. ‘‘unsatisfactory’’ rating in more than one of
(viii) The physical, emotional, and develop- the required areas.
mental needs of and ways to work with the
(5) The HHA must maintain documentation
populations served by the HHA, including
which demonstrates that the requirements of
the need for respect for the patient, his or
this standard have been met.
her privacy, and his or her property.
(d) Standard: In-service training. A home
(ix) Appropriate and safe techniques in per-
health aide must receive at least 12 hours of
forming personal hygiene and grooming
in-service training during each 12-month pe-
tasks that include—
riod. In-service training may occur while an
(A) Bed bath;
(B) Sponge, tub, and shower bath; aide is furnishing care to a patient.
(C) Hair shampooing in sink, tub, and bed; (1) In-service training may be offered by
(D) Nail and skin care; any organization and must be supervised by
(E) Oral hygiene; a registered nurse.
(F) Toileting and elimination; (2) The HHA must maintain documentation
(x) Safe transfer techniques and ambula- that demonstrates the requirements of this
tion; standard have been met.
(xi) Normal range of motion and posi- (e) Standard: Qualifications for instructors
tioning; conducting classroom and supervised practical
(xii) Adequate nutrition and fluid intake; training. Classroom and supervised practical
(xiii) Recognizing and reporting changes in training must be performed by a registered
skin condition; and nurse who possesses a minimum of 2 years
(xiv) Any other task that the HHA may nursing experience, at least 1 year of which
choose to have an aide perform as permitted must be in home health care, or by other in-
under state law. dividuals under the general supervision of
(xv) The HHA is responsible for training the registered nurse.
home health aides, as needed, for skills not (f) Standard: Eligible training and com-
covered in the basic checklist, as described petency evaluation organizations. A home
in paragraph (b)(3)(ix) of this section. health aide training program and com-
(4) The HHA must maintain documentation petency evaluation program may be offered
that demonstrates that the requirements of by any organization except by an HHA that,
this standard have been met. within the previous 2 years:
169
(1) Was out of compliance with the require- (ii) The performance of simple procedures
ments of paragraphs (b), (c), (d), or (e) of this as an extension of therapy or nursing serv-
section; or ices;
(2) Permitted an individual who does not (iii) Assistance in ambulation or exercises;
meet the definition of a ‘‘qualified home and
health aide’’ as specified in paragraph (a) of (iv) Assistance in administering medica-
this section to furnish home health aide tions ordinarily self-administered.
services (with the exception of licensed (4) Home health aides must be members of
health professionals and volunteers); or the interdisciplinary team, must report
(3) Was subjected to an extended (or par- changes in the patient’s condition to a reg-
tially extended) survey as a result of having istered nurse or other appropriate skilled
been found to have furnished substandard professional, and must complete appropriate
care (or for other reasons as determined by records in compliance with the HHA’s poli-
CMS or the state); or cies and procedures.
(4) Was assessed a civil monetary penalty (h) Standard: Supervision of home health
of $5,000 or more as an intermediate sanc- aides. (1)(i) If home health aide services are
tion; or provided to a patient who is receiving skilled
(5) Was found to have compliance defi- nursing, physical or occupational therapy, or
ciencies that endangered the health and safe- speech-language pathology services, a reg-
ty of the HHA’s patients, and had temporary istered nurse or other appropriate skilled
management appointed to oversee the man- professional who is familiar with the patient,
agement of the HHA; or the patient’s plan of care, and the written
(6) Had all or part of its Medicare pay- patient care instructions described in
ments suspended; or § 484.80(g), must make an onsite visit to the
(7) Was found under any federal or state patient’s home no less frequently than every
law to have: 14 days. The home health aide does not have
(i) Had its participation in the Medicare to be present during this visit.
program terminated; or (ii) If an area of concern in aide services is
(ii) Been assessed a penalty of $5,000 or noted by the supervising registered nurse or
more for deficiencies in federal or state other appropriate skilled professional, then
standards for HHAs; or the supervising individual must make an on-
(iii) Been subjected to a suspension of site visit to the location where the patient is
Medicare payments to which it otherwise receiving care in order to observe and assess
would have been entitled; or the aide while he or she is performing care.
(iv) Operated under temporary manage- (iii) A registered nurse or other appro-
ment that was appointed to oversee the oper- priate skilled professional must make an an-
ation of the HHA and to ensure the health nual on-site visit to the location where a pa-
and safety of the HHA’s patients; or tient is receiving care in order to observe
(v) Been closed, or had its patients trans- and assess each aide while he or she is per-
ferred by the state; or forming care.
(vi) Been excluded from participating in (2) If home health aide services are pro-
federal health care programs or debarred vided to a patient who is not receiving
from participating in any government pro- skilled nursing care, physical or occupa-
gram. tional therapy, or speech-language pathology
(g) Standard: Home health aide assignments services, the registered nurse must make an
and duties. (1) Home health aides are as- on-site visit to the location where the pa-
signed to a specific patient by a registered tient is receiving care no less frequently
nurse or other appropriate skilled profes- than every 60 days in order to observe and
sional, with written patient care instruc- assess each aide while he or she is per-
tions for a home health aide prepared by forming care.
that registered nurse or other appropriate (3) If a deficiency in aide services is
skilled professional (that is, physical thera- verified by the registered nurse or other ap-
pist, speech-language pathologist, or occupa- propriate skilled professional during an on-
tional therapist). site visit, then the agency must conduct, and
(2) A home health aide provides services the home health aide must complete a com-
that are: petency evaluation in accordance with para-
(i) Ordered by the physician; graph (c) of this section.
(ii) Included in the plan of care; (4) Home health aide supervision must en-
(iii) Permitted to be performed under state sure that aides furnish care in a safe and ef-
law; and fective manner, including, but not limited
(iv) Consistent with the home health aide to, the following elements:
training.
(i) Following the patient’s plan of care for

(3) The duties of a home health aide in- completion of tasks assigned to a home
clude: health aide by the registered nurse or other
(i) The provision of hands-on personal care; appropriate skilled professional;
170
(ii) Maintaining an open communication (b) Standard: Duties of the licensed
process with the patient, representative (if practical nurse. The licensed practical
any), caregivers, and family; nurse furnishes services in accordance
(iii) Demonstrating competency with as- with agency policies, prepares clinical
signed tasks;
and progress notes, assists the physi-
(iv) Complying with infection prevention
and control policies and procedures;
cian and registered nurse in performing
(v) Reporting changes in the patient’s con- specialized procedures, prepares equip-
dition; and ment and materials for treatments ob-
(vi) Honoring patient rights. serving aseptic technique as required,
(5) If the home health agency chooses to and assists the patient in learning ap-
provide home health aide services under ar- propriate self-care techniques.
rangements, as defined in section 1861(w)(1)
of the Act, the HHA’s responsibilities also
FR 32974, July 18, 1991]
include, but are not limited to:
(i) Ensuring the overall quality of care pro- § 484.32 Condition of participation:
vided by an aide; Therapy services.
(ii) Supervising aide services as described
in paragraphs (h)(1) and (2) of this section; Any therapy services offered by the
and HHA directly or under arrangement are
(iii) Ensuring that home health aides who given by a qualified therapist or by a
provide services under arrangement have qualified therapy assistant under the
met the training or competency evaluation supervision of a qualified therapist and
requirements, or both, of this part. in accordance with the plan of care.
(i) Standard: Individuals furnishing Medicaid The qualified therapist assists the phy-
personal care aide-only services under a Med-
icaid personal care benefit. An individual may
sician in evaluating level of function,
furnish personal care services, as defined in helps develop the plan of care (revising
§ 440.167 of this chapter, on behalf of an HHA. it as necessary), prepares clinical and
Before the individual may furnish personal progress notes, advises and consults
care services, the individual must meet all with the family and other agency per-
qualification standards established by the sonnel, and participates in in-service
state. The individual only needs to dem- programs.
onstrate competency in the services the indi- (a) Standard: Supervision of physical
vidual is required to furnish. therapy assistant and occupational ther-
apy assistant. Services furnished by a
Subpart C—Furnishing of Services qualified physical therapy assistant or
qualified occupational therapy assist-
§ 484.30 Condition of participation: ant may be furnished under the super-
Skilled nursing services. vision of a qualified physical or occu-
The HHA furnishes skilled nursing pational therapist. A physical therapy
services by or under the supervision of assistant or occupational therapy as-
a registered nurse and in accordance sistant performs services planned, dele-
with the plan of care. gated, and supervised by the therapist,
(a) Standard: Duties of the registered assists in preparing clinical notes and
nurse. The registered nurse makes the progress reports, and participates in
initial evaluation visit, regularly re- educating the patient and family, and
evaluates the patient’s nursing needs, in in-service programs.
initiates the plan of care and necessary (b) Standard: Supervision of speech
revisions, furnishes those services re- therapy services. Speech therapy serv-
quiring substantial and specialized ices are furnished only by or under su-
nursing skill, initiates appropriate pre- pervision of a qualified speech patholo-
ventive and rehabilitative nursing pro- gist or audiologist.
cedures, prepares clinical and progress [54 FR 33367, Aug. 14, 1989, as amended at 56
notes, coordinates services, informs the FR 32974, July 18, 1991]
physician and other personnel of
changes in the patient’s condition and § 484.34 Condition of participation:
needs, counsels the patient and family Medical social services.
in meeting nursing and related needs, If the agency furnishes medical so-
participates in in-service programs, cial services, those services are given

and supervises and teaches other nurs- by a qualified social worker or by a
ing personnel. qualified social work assistant under
171
§ 484.36 42 CFR Ch. IV (10–1–17 Edition)
the supervision of a qualified social (vii) Recognizing emergencies and

worker, and in accordance with the knowledge of emergency procedures.
plan of care. The social worker assists (viii) The physical, emotional, and
the physician and other team members developmental needs of and ways to
in understanding the significant social work with the populations served by
and emotional factors related to the the HHA, including the need for respect
health problems, participates in the de- for the patient, his or her privacy and
velopment of the plan of care, prepares his or her property.
clinical and progress notes, works with (ix) Appropriate and safe techniques
the family, uses appropriate commu- in personal hygiene and grooming that
nity resources, participates in dis- include—
charge planning and in-service pro- (A) Bed bath.
grams, and acts as a consultant to (B) Sponge, tub, or shower bath.
other agency personnel. (C) Shampoo, sink, tub, or bed.
(D) Nail and skin care.
§ 484.36 Condition of participation: (E) Oral hygiene.
Home health aide services. (F) Toileting and elimination.
Home health aides are selected on (x) Safe transfer techniques and am-
the basis of such factors as a sympa- bulation.
thetic attitude toward the care of the (xi) Normal range of motion and posi-
sick, ability to read, write, and carry tioning.
out directions, and maturity and abil- (xii) Adequate nutrition and fluid in-
ity to deal effectively with the de- take.
mands of the job. They are closely su- (xiii) Any other task that the HHA
pervised to ensure their competence in may choose to have the home health
providing care. For home health serv- aide perform.
ices furnished (either directly or ‘‘Supervised practical training’’
through arrangements with other orga- means training in a laboratory or other
nizations) after August 14, 1990, the setting in which the trainee dem-
HHA must use individuals who meet onstrates knowledge while performing
the personnel qualifications specified tasks on an individual under the direct
in § 484.4 for ‘‘home health aide’’. supervision of a registered nurse or li-
censed practical nurse.
(a) Standard: Home health aide train-
(2) Conduct of training—(i) Organiza-
ing—(1) Content and duration of training.
tions. A home health aide training pro-
The aide training program must ad-
gram may be offered by any organiza-
dress each of the following subject
tion except an HHA that, within the
areas through classroom and super-
previous 2 years has been found—
vised practical training totalling at
(A) Out of compliance with require-
least 75 hours, with at least 16 hours
ments of this paragraph (a) or para-
devoted to supervised practical train-
graph (b) of this section;
ing. The individual being trained must
(B) To permit an individual that does
complete at least 16 hours of classroom
not meet the definition of ‘‘home
training before beginning the
health aide’’ as specified in § 484.4 to
supervisied practical training.
furnish home health aide services (with
(i) Communications skills. the exception of licensed health profes-
(ii) Observation, reporting and docu- sionals and volunteers);
mentation of patient status and the (C) Has been subject to an extended
care or service furnished. (or partial extended) survey as a result
(iii) Reading and recording tempera- of having been found to have furnished
ture, pulse, and respiration. substandard care (or for other reasons
(iv) Basic infection control proce- at the discretion of the CMS or the
dures. State);
(v) Basic elements of body func- (D) Has been assessed a civil mone-
tioning and changes in body function tary penalty of not less than $5,000 as
that must be reported to an aide’s su- an intermediate sanction;
pervisor. (E) Has been found to have compli-

(vi) Maintenance of a clean, safe, and ance deficiencies that endanger the
healthy environment. health and safety of the HHA’s patients
172
and has had a temporary management (ii) The HHA must complete a per-
appointed to oversee the management formance review of each home health
of the HHA; aide no less frequently than every 12
(F) Has had all or part of its Medi- months.
care payments suspended; or (iii) The home health aide must re-
(G) Under any Federal or State law ceive at least 12 hours of in-service
within the 2-year period beginning on training during each 12-month period.
October 1, 1988— The in-service training may be fur-
(1) Has had its participation in the nished while the aide is furnishing care
Medicare program terminated; to the patient.
(2) Has been assessed a penalty of not (3) Conduct of evaluation and train-
less than $5,000 for deficiencies in Fed- ing—(i) Organizations. A home health
eral or State standards for HHAs; aide competency evaluation program
(3) Was subject to a suspension of may be offered by any organization ex-
Medicare payments to which it other- cept as specified in paragraph (a)(2)(i)
wise would have been entitled; of this section.
(4) Had operated under a temporary The in-service training may be of-
management that was appointed to fered by any organization.
oversee the operation of the HHA and (ii) Evaluators and instructors. The
to ensure the health and safety of the competency evaluation must be per-
HHA’s patients; or formed by a registered nurse. The in-
(5) Was closed or had it’s residents service training generally must be su-
transferred by the State. pervised by a registered nurse who pos-
(ii) Qualifications for instructors. The sesses a minimum of 2 years of nursing
training of home health aides and the experience at least 1 year of which
supervision of home health aides dur- must be in the provision of home
ing the supervised practical portion of health care.
the training must be performed by or (iii) Subject areas. The subject areas
under the general supervision of a reg- listed at paragraphs (a)(1) (iii), (ix), (x),
istered nurse who possesses a minimum and (xi) of this section must be evalu-
of 2 years of nursing experience, at ated after observation of the aide’s per-
least 1 year of which must be in the formance of the tasks with a patient.
provision of home health care. Other The other subject areas in paragraph
individuals may be used to provide in- (a)(1) of this section may be evaluated
struction under the supervision of a through written examination, oral ex-
qualified registered nurse. amination, or after observation of a
(3) Documentation of training. The home health aide with a patient.
HHA must maintain sufficient docu- (4) Competency determination. (i) A
mentation to demonstrate that the re- home health aide is not considered
quirements of this standard are met. competent in any task for which he or
(b) Standard: Competency evaluation she is evaluated as ‘‘unsatisfactory’’.
and in-service training—(1) Applicability. The aide must not perform that task
An individual may furnish home health without direct supervision by a li-
aide services on behalf of an HHA only censed nurse until after he or she re-
after that individual has successfully ceives training in the task for which he
completed a competency evaluation or she was evaluated as ‘‘unsatisfac-
program as described in this paragraph. tory’’ and passes a subsequent evalua-
The HHA is responsible for ensuring tion with ‘‘satisfactory’’.
that the individuals who furnish home (ii) A home health aide is not consid-
health aide services on its behalf meet ered to have successfully passed a com-
the competency evaluation require- petency evaluation if the aide has an
ments of this section. ‘‘unsatisfactory’’ rating in more than
(2) Content and frequency of evalua- one of the required areas.
tions and amount of in-service training. (5) Documentation of competency eval-
(i) The competency evaluation must uation. The HHA must maintain docu-
address each of the subjects listed in mentation which demonstrates that

paragraph (a)(1) (ii) through (xiii) of the requirements of this standard are
this section. met.
173
§ 484.36 42 CFR Ch. IV (10–1–17 Edition)
(6) Effective date. The HHA must im- ing skilled nursing care, physical or oc-
plement a competency evaluation pro- cupational therapy or speech-language
gram that meets the requirements of pathology services, the registered
this paragraph before February 14, 1990. nurse must make a supervisory visit to
The HHA must provide the preparation the patient’s home no less frequently
necessary for the individual to success- than every 60 days. In these cases, to
fully complete the competency evalua- ensure that the aide is properly caring
tion program. After August 14, 1990, the for the patient, each supervisory visit
HHA may use only those aides that must occur while the home health aide
have been found to be competent in ac- is providing patient care.
cordance with § 484.36(b). (4) If home health aide services are
(c) Standard: Assignment and duties of provided by an individual who is not
the home health aide—(1) Assignment. employed directly by the HHA (or hos-
The home health aide is assigned to a pice), the services of the home health
specific patient by the registered aide must be provided under arrange-
nurse. Written patient care instruc- ments, as defined in section 1861(w)(1)
tions for the home health aide must be of the Act. If the HHA (or hospice)
prepared by the registered nurse or chooses to provide home health aide
other appropriate professional who is services under arrangements with an-
responsible for the supervision of the other organization, the HHA’s (or hos-
home health aide under paragraph (d) pice’s) responsibilities include, but are
of this section. not limited to—
(2) Duties. The home health aide pro- (i) Ensuring the overall quality of the
vides services that are ordered by the care provided by the aide;
physician in the plan of care and that (ii) Supervision of the aide’s services
the aide is permitted to perform under as described in paragraphs (d)(1) and
State law. The duties of a home health (d)(2) of this section; and
aide include the provision of hands-on (iii) Ensuring that home health aides
personal care, performance of simple providing services under arrangements
procedures as an extension of therapy have met the training requirements of
or nursing services, assistance in am- paragraphs (a) and (b) of this section.
bulation or exercises, and assistance in (e) Personal care attendant: Evaluation
administering medications that are or- requirements—(1) Applicability. This
dinarily self-administered. Any home paragraph applies to individuals who
health aide services offered by an HHA are employed by HHAs exclusively to
must be provided by a qualified home furnish personal care attendant serv-
health aide. ices under a Medicaid personal care
(d) Standard: Supervision. (1) If the pa- benefit.
tient receives skilled nursing care, the (2) Rule. An individual may furnish
registered nurse must perform the su- personal care services, as defined in
pervisory visit required by paragraph § 440.170 of this chapter, on behalf of an
(d)(2) of this section. If the patient is HHA after the individual has been
not receiving skilled nursing care, but found competent by the State to fur-
is receiving another skilled service nish those services for which a com-
(that is, physical therapy, occupational petency evaluation is required by para-
therapy, or speech-language pathology graph (b) of this section and which the
services), supervision may be provided individual is required to perform. The
by the appropriate therapist. individual need not be determined com-
(2) The registered nurse (or another petent in those services listed in para-
professional described in paragraph graph (a) of this section that the indi-
(d)(1) of this section) must make an on- vidual is not required to furnish.
site visit to the patient’s home no less [54 FR 33367, Aug. 14, 1989, as amended at 56
frequently than every 2 weeks. FR 32974, July 18, 1991; 56 FR 51334, Oct. 11,
(3) If home health aide services are 1991; 59 FR 65498, Dec. 20, 1994; 60 FR 39123,
provided to a patient who is not receiv- Aug. 1, 1995; 66 FR 32778, June 18, 2001]
174
§ 484.38 Condition of participation: § 484.52 Condition of participation:

Qualifying to furnish outpatient Evaluation of the agency’s program.
physical therapy or speech pathol-
ogy services. The HHA has written policies requir-
ing an overall evaluation of the agen-
An HHA that wishes to furnish out- cy’s total program at least once a year
patient physical therapy or speech pa- by the group of professional personnel
thology services must meet all the per- (or a committee of this group), HHA
tinent conditions of this part and also staff, and consumers, or by professional
meet the additional health and safety people outside the agency working in
requirements set forth in §§ 485.711,
conjunction with consumers. The eval-
485.713, 485.715, 485.719, 485.723, and
uation consists of an overall policy and
485.727 of this chapter to implement
administrative review and a clinical
section 1861(p) of the Act.
record review. The evaluation assesses
[54 FR 33367, Aug. 14, 1989, as amended at 60 the extent to which the agency’s pro-
FR 2329, Jan. 9, 1995; 60 FR 11632, Mar. 2, 1995] gram is appropriate, adequate, effec-
tive, and efficient. Results of the eval-
§ 484.48 Condition of participation: uation are reported to and acted upon
Clinical records.
by those responsible for the operation
A clinical record containing perti- of the agency and are maintained sepa-
nent past and current findings in ac- rately as administrative records.
cordance with accepted professional (a) Standard: Policy and administrative
standards is maintained for every pa- review. As a part of the evaluation
tient receiving home health services. process the policies and administrative
In addition to the plan of care, the practices of the agency are reviewed to
record contains appropriate identifying determine the extent to which they
information; name of physician; drug, promote patient care that is appro-
dietary, treatment, and activity or-
priate, adequate, effective, and effi-
ders; signed and dated clinical and
cient. Mechanisms are established in
progress notes; copies of summary re-
writing for the collection of pertinent
ports sent to the attending physician;
data to assist in evaluation.
and a discharge summary. The HHA
must inform the attending physician of (b) Standard: Clinical record review. At
the availability of a discharge sum- least quarterly, appropriate health pro-
mary. The discharge summary must be fessionals, representing at least the
sent to the attending physician upon scope of the program, review a sample
request and must include the patient’s of both active and closed clinical
medical and health status at discharge. records to determine whether estab-
(a) Standards: Retention of records. lished policies are followed in fur-
Clinical records are retained for 5 years nishing services directly or under ar-
after the month the cost report to rangement. There is a continuing re-
which the records apply is filed with view of clinical records for each 60-day
the intermediary, unless State law period that a patient receives home
stipulates a longer period of time. Poli- health services to determine adequacy
cies provide for retention even if the of the plan of care and appropriateness
HHA discontinues operations. If a pa- of continuation of care.
tient is transferred to another health [54 FR 33367, Aug. 14, 1989; 66 FR 32778, June
facility, a copy of the record or ab- 18, 2001]
stract is sent with the patient.
(b) Standards: Protection of records. § 484.55 Condition of participation:
Clinical record information is safe- Comprehensive assessment of pa-
guarded against loss or unauthorized tients.
use. Written procedures govern use and Each patient must receive, and an
removal of records and the conditions HHA must provide, a patient-specific,
for release of information. Patient’s comprehensive assessment that accu-
written consent is required for release rately reflects the patient’s current
of information not authorized by law. health status and includes information

[54 FR 33367, Aug. 14, 1989, as amended at 60 that may be used to demonstrate the
FR 65498, Dec. 20, 1994] patient’s progress toward achievement
175
§ 484.55 42 CFR Ch. IV (10–1–17 Edition)
of desired outcomes. The comprehen- speech-language pathologist or occupa-

sive assessment must identify the pational therapist may complete the
tient’s continuing need for home care comprehensive assessment, and for
and meet the patient’s medical, nurs- Medicare patients, determine eligi-
ing, rehabilitative, social, and dis- bility for the Medicare home health
charge planning needs. For Medicare benefit, including homebound status.
beneficiaries, the HHA must verify the The occupational therapist may com-
patient’s eligibility for the Medicare plete the comprehensive assessment if
home health benefit including home- the need for occupational therapy es-
bound status, both at the time of the tablishes program eligibility.
initial assessment visit and at the time
(c) Standard: Drug regimen review. The
of the comprehensive assessment. The
comprehensive assessment must in-
comprehensive assessment must also
incorporate the use of the current clude a review of all medications the
version of the Outcome and Assessment patient is currently using in order to
Information Set (OASIS) items, using identify any potential adverse effects
the language and groupings of the and drug reactions, including ineffec-
OASIS items, as specified by the Sec- tive drug therapy, significant side ef-
retary. fects, significant drug interactions, du-
(a) Standard: Initial assessment visit. plicate drug therapy, and noncompli-
(1) A registered nurse must conduct an ance with drug therapy.
initial assessment visit to determine (d) Standard: Update of the comprehen-
the immediate care and support needs sive assessment. The comprehensive as-
of the patient; and, for Medicare pa- sessment must be updated and revised
tients, to determine eligibility for the (including the administration of the
Medicare home health benefit, includ- OASIS) as frequently as the patient’s
ing homebound status. The initial as- condition warrants due to a major de-
sessment visit must be held either cline or improvement in the patient’s
within 48 hours of referral, or within 48 health status, but not less frequently
hours of the patient’s return home, or than—
on the physician-ordered start of care (1) The last five days of every 60 days
date.
beginning with the start-of-care date,
(2) When rehabilitation therapy serv-
unless there is a—
ice (speech language pathology, phys-
ical therapy, or occupational therapy) (i) Beneficiary elected transfer;
is the only service ordered by the phy- (ii) Significant change in condition;
sician, and if the need for that service or
establishes program eligibility, the ini- (iii) Discharge and return to the
tial assessment visit may be made by same HHA during the 60-day episode.
the appropriate rehabilitation skilled (2) Within 48 hours of the patient’s
professional. return to the home from a hospital ad-
(b) Standard: Completion of the commission of 24 hours or more for any
prehensive assessment. (1) The com- reason other than diagnostic tests;
prehensive assessment must be com- (3) At discharge.
pleted in a timely manner, consistent (e) Standard: Incorporation of OASIS
with the patient’s immediate needs, data items. The OASIS data items de-
but no later than 5 calendar days after termined by the Secretary must be in-
the start of care. corporated into the HHA’s own assess-
(2) Except as provided in paragraph ment and must include: clinical record
(b)(3) of this section, a registered nurse
items, demographics and patient his-
must complete the comprehensive as-
tory, living arrangements, supportive
sessment and for Medicare patients, de-
termine eligibility for the Medicare assistance, sensory status,
home health benefit, including home- integumentary status, respiratory sta-
bound status. tus, elimination status, neuro/emo-
(3) When physical therapy, speech- tional/behavioral status, activities of
language pathology, or occupational daily living, medications, equipment

therapy is the only service ordered by management, emergent care, and data
the physician, a physical therapist,
176
Centers for Medicare & Medicaid Services, HHS Subpart C, Nt.
items collected at inpatient facility ad- patient’s equipment when assisting with self-
mission or discharge only. administered tests.
(2) If the HHA refers specimens for labora-
[64 FR 3784, Jan. 25, 1999, as amended at 65 tory testing, the referral laboratory must be
FR 41211, July 3, 2000; 74 FR 58134, Nov. 10, certified in the appropriate specialties and
2009] subspecialties of services in accordance with
EFFECTIVE DATE NOTE: At 82 FR 4578, Jan. the applicable requirements of part 493 of
13, 2017, subpart C was revised, effective July this chapter.
13, 2017. At 82 FR 31732, July 10, 2017, this
amendment was corrected. At 82 FR 31729, § 484.102 Condition of participation: Emer-
gency preparedness.
July 10, 2017, this amendment was delayed
until Jan. 13, 2018. For the convenience of the The Home Health Agency (HHA) must
user, the revised text is set forth as follows: comply with all applicable Federal, State,
and local emergency preparedness require-
Subpart C—Organizational ments. The HHA must establish and main-
Environment tain an emergency preparedness program
that meets the requirements of this section.
§ 484.100 Condition of participation: Compli- The emergency preparedness program must
ance with Federal, State, and local laws include, but not be limited to, the following
and regulations related to the health and elements:
safety of patients.
(a) Emergency plan. The HHA must develop
The HHA and its staff must operate and and maintain an emergency preparedness
furnish services in compliance with all appli- plan that must be reviewed, and updated at
cable federal, state, and local laws and regu- least annually. The plan must do all of the
lations related to the health and safety of following:
patients. If state or local law provides licens- (1) Be based on and include a documented,
ing of HHAs, the HHA must be licensed. facility-based and community-based risk as-
(a) Standard: Disclosure of ownership and sessment, utilizing an all-hazards approach.
management information. The HHA must com-
(2) Include strategies for addressing emer-
ply with the requirements of part 420 subpart
gency events identified by the risk assess-
C, of this chapter. The HHA also must dis-
ment.
close the following information to the state
(3) Address patient population, including,
survey agency at the time of the HHA’s ini-
but not limited to, the type of services the
tial request for certification, for each sur-
vey, and at the time of any change in owner- HHA has the ability to provide in an emer-
ship or management: gency; and continuity of operations, includ-
(1) The names and addresses of all persons ing delegations of authority and succession
with an ownership or controlling interest in plans.
the HHA as defined in § 420.201, § 420.202, and (4) Include a process for cooperation and
§ 420.206 of this chapter. collaboration with local, tribal, regional,
(2) The name and address of each person State, and Federal emergency preparedness
who is an officer, a director, an agent, or a officials’ efforts to maintain an integrated
managing employee of the HHA as defined in response during a disaster or emergency sit-
§ 420.201, § 420.202, and § 420.206 of this chapter. uation, including documentation of the
(3) The name and business address of the HHA’s efforts to contact such officials and,
corporation, association, or other company when applicable, of its participation in col-
that is responsible for the management of laborative and cooperative planning efforts.
the HHA, and the names and addresses of the (b) Policies and procedures. The HHA must
chief executive officer and the chairperson of develop and implement emergency prepared-
the board of directors of that corporation, ness policies and procedures, based on the
association, or other company responsible emergency plan set forth in paragraph (a) of
for the management of the HHA. this section, risk assessment at paragraph
(b) Standard: Licensing. The HHA, its (a)(1) of this section, and the communication
branches, and all persons furnishing services plan at paragraph (c) of this section. The
to patients must be licensed, certified, or policies and procedures must be reviewed and
registered, as applicable, in accordance with updated at least annually. At a minimum,
the state licensing authority as meeting the policies and procedures must address the
those requirements. following:
(c) Standard: Laboratory services. (1) If the (1) The plans for the HHA’s patients during
HHA engages in laboratory testing outside of a natural or man-made disaster. Individual
the context of assisting an individual in self- plans for each patient must be included as
administering a test with an appliance that part of the comprehensive patient assess-
has been cleared for that purpose by the ment, which must be conducted according to
the provisions at § 484.55.
Food and Drug Administration, the testing

must be in compliance with all applicable re- (2) The procedures to inform State and
quirements of part 493 of this chapter. The local emergency preparedness officials about
HHA may not substitute its equipment for a HHA patients in need of evacuation from
177
Subpart C, Nt. 42 CFR Ch. IV (10–1–17 Edition)
their residences at any time due to an emer- testing program must be reviewed and up-
gency situation based on the patient’s med- dated at least annually.
ical and psychiatric condition and home en- (1) Training program. The HHA must do all
vironment. of the following:
(3) The procedures to follow up with on- (i) Initial training in emergency prepared-
duty staff and patients to determine services ness policies and procedures to all new and
that are needed, in the event that there is an existing staff, individuals providing services
interruption in services during or due to an under arrangement, and volunteers, con-
emergency. The HHA must inform State and sistent with their expected roles.
local officials of any on-duty staff or pa- (ii) Provide emergency preparedness train-
tients that they are unable to contact.
ing at least annually.
(4) A system of medical documentation
that preserves patient information, protects (iii) Maintain documentation of the train-
confidentiality of patient information, and ing.
secures and maintains the availability of (ii) Demonstrate staff knowledge of emer-
records. gency procedures.
(5) The use of volunteers in an emergency (2) Testing. The HHA must conduct exer-
or other emergency staffing strategies, in- cises to test the emergency plan at least an-
cluding the process and role for integration nually. The HHA must do the following:
of State or Federally designated health care (i) Participate in a full-scale exercise that
professionals to address surge needs during is community-based or when a community-
an emergency. based exercise is not accessible, an indi-
(c) Communication plan. The HHA must de- vidual, facility-based. If the HHA experi-
velop and maintain an emergency prepared- ences an actual natural or man-made emer-
ness communication plan that complies with gency that requires activation of the emer-
Federal, State, and local laws and must be gency plan, the HHA is exempt from engag-
reviewed and updated at least annually. The ing in a community-based or individual, fa-
communication plan must include all of the cility-based full-scale exercise for 1 year fol-
following: lowing the onset of the actual event.
(1) Names and contact information for the (ii) Conduct an additional exercise that
following: may include, but is not limited to the fol-
(i) Staff. lowing:
(ii) Entities providing services under ar- (A) A second full-scale exercise that is
rangement. community-based or individual, facility-
(iii) Patients’ physicians. based.
(iv) Volunteers. (B) A tabletop exercise that includes a
(2) Contact information for the following: group discussion led by a facilitator, using a
(i) Federal, State, tribal, regional, or local narrated, clinically-relevant emergency sce-
emergency preparedness staff. nario, and a set of problem statements, di-
(ii) Other sources of assistance.
rected messages, or prepared questions de-
(3) Primary and alternate means for com-
signed to challenge an emergency plan.
municating with the HHA’s staff, Federal,
(iii) Analyze the HHA’s response to and
State, tribal, regional, and local emergency
maintain documentation of all drills, table-
management agencies.
(4) A method for sharing information and top exercises, and emergency events, and re-
medical documentation for patients under vise the HHA’s emergency plan, as needed.
the HHA’s care, as necessary, with other (e) Integrated healthcare systems. If a HHA is
health care providers to maintain the con- part of a healthcare system consisting of
tinuity of care. multiple separately certified healthcare fa-
(5) A means of providing information about cilities that elects to have a unified and in-
the general condition and location of pa- tegrated emergency preparedness program,
tients under the facility’s care as permitted the HHA may choose to participate in the
under 45 CFR 164.510(b)(4). healthcare system’s coordinated emergency
(6) A means of providing information about preparedness program. If elected, the unified
the HHA’s needs, and its ability to provide and integrated emergency preparedness pro-
assistance, to the authority having jurisdic- gram must do all of the following:
tion, the Incident Command Center, or des- (1) Demonstrate that each separately cer-
ignee. tified facility within the system actively
(d) Training and testing. The HHA must de- participated in the development of the uni-
velop and maintain an emergency prepared- fied and integrated emergency preparedness
ness training and testing program that is program.
based on the emergency plan set forth in (2) Be developed and maintained in a man-
paragraph (a) of this section, risk assessment ner that takes into account each separately
certified facility’s unique circumstances, pa-
at paragraph (a)(1) of this section, policies

and procedures at paragraph (b) of this sec- tient populations, and services offered.
tion, and the communication plan at para- (3) Demonstrate that each separately cer-
graph (c) of this section. The training and tified facility is capable of actively using the
178
unified and integrated emergency prepared- responsibilities and obligations as the ad-
ness program and is in compliance with the ministrator. The pre-designated person may
program. be the clinical manager as described in para-
(4) Include a unified and integrated emer- graph (c) of this section.
gency plan that meets the requirements of (3) The administrator or a pre-designated
paragraphs (a)(2), (3), and (4) of this section. person is available during all operating
The unified and integrated emergency plan hours.
must also be based on and include all of the (c) Clinical manager. One or more qualified
following: individuals must provide oversight of all pa-
(i) A documented community-based risk tient care services and personnel. Oversight
assessment, utilizing an all-hazards ap- must include the following—
proach. (1) Making patient and personnel assign-
(ii) A documented individual facility-based ments,
risk assessment for each separately certified (2) Coordinating patient care,
facility within the health system, utilizing (3) Coordinating referrals,
an all-hazards approach. (4) Assuring that patient needs are contin-
(5) Include integrated policies and proce- ually assessed, and
dures that meet the requirements set forth (5) Assuring the development, implementa-
in paragraph (b) of this section, a coordi- tion, and updates of the individualized plan
nated communication plan and training and of care.
testing programs that meet the require- (d) Standard: Parent-branch relationship. (1)
ments of paragraphs (c) and (d) of this sec- The parent HHA is responsible for reporting
tion, respectively. all branch locations of the HHA to the state
survey agency at the time of the HHA’s re-
§ 484.105 Condition of participation: Organi- quest for initial certification, at each sur-
zation and administration of services. vey, and at the time the parent proposes to
The HHA must organize, manage, and ad- add or delete a branch.
minister its resources to attain and main- (2) The parent HHA provides direct support
tain the highest practicable functional ca- and administrative control of its branches.
pacity, including providing optimal care to (e) Standard: Services under arrangement. (1)
achieve the goals and outcomes identified in The HHA must ensure that all services fur-
the patient’s plan of care, for each patient’s nished under arrangement provided by other
medical, nursing, and rehabilitative needs. entities or individuals meet the require-
The HHA must assure that administrative ments of this part and the requirements of
and supervisory functions are not delegated section 1861(w) of the Act (42 U.S.C. 1395x
to another agency or organization, and all (w)).
services not furnished directly are monitored (2) An HHA must have a written agreement
and controlled. The HHA must set forth, in with another agency, with an organization,
writing, its organizational structure, includ- or with an individual when that entity or in-
ing lines of authority, and services fur- dividual furnishes services under arrange-
nished. ment to the HHA’s patients. The HHA must
(a) Standard: Governing body. A governing maintain overall responsibility for the serv-
body (or designated persons so functioning) ices provided under arrangement, as well as
must assume full legal authority and respon- the manner in which they are furnished. The
sibility for the agency’s overall management agency, organization, or individual providing
and operation, the provision of all home services under arrangement may not have
health services, fiscal operations, review of been:
the agency’s budget and its operational (i) Denied Medicare or Medicaid enroll-
plans, and its quality assessment and per- ment;
formance improvement program. (ii) Been excluded or terminated from any
(b) Standard: Administrator. (1) The admin- federal health care program or Medicaid;
istrator must: (iii) Had its Medicare or Medicaid billing
(i) Be appointed by and report to the gov- privileges revoked; or
erning body; (iv) Been debarred from participating in
(ii) Be responsible for all day-to-day oper- any government program.
ations of the HHA; (3) The primary HHA is responsible for pa-
(iii) Ensure that a clinical manager as de- tient care, and must conduct and provide, ei-
scribed in paragraph (c) of this section is ther directly or under arrangements, all
available during all operating hours; services rendered to patients.
(iv) Ensure that the HHA employs qualified (f) Standard: Services furnished. (1) Skilled
personnel, including assuring the develop- nursing services and at least one other
ment of personnel qualifications and poli- therapeutic service (physical therapy,
cies. speech-language pathology, or occupational
(2) When the administrator is not avail- therapy; medical social services; or home
able, a qualified, pre-designated person, who health aide services) are made available on a
is authorized in writing by the administrator visiting basis, in a place of residence used as
and the governing body, assumes the same a patient’s home. An HHA must provide at
179
least one of the services described in this (ii) If the anticipated source of financing
subsection directly, but may provide the sec- is, in any part, the anticipated payment
ond service and additional services under ar- from title V (Maternal and Child Health
rangement with another agency or organiza- Services Block Grant) or title XVIII (Medi-
tion. care) or title XIX (Medicaid) of the Social
(2) All HHA services must be provided in Security Act, the plan specifies the fol-
accordance with current clinical practice lowing:
guidelines and accepted professional stand- (A) Whether the proposed capital expendi-
ards of practice. ture is required to conform, or is likely to be
(g) Standard: Outpatient physical therapy or required to conform, to current standards,
speech-language pathology services. An HHA criteria, or plans developed in accordance
that furnishes outpatient physical therapy with the Public Health Service Act or the
or speech-language pathology services must Mental Retardation Facilities and Commu-
meet all of the applicable conditions of this nity Mental Health Centers Construction
part and the additional health and safety re- Act of 1963.
quirements set forth in § 485.711, § 485.713, (B) Whether a capital expenditure proposal
§ 485.715, § 485.719, § 485.723, and § 485.727 of this has been submitted to the designated plan-
chapter to implement section 1861(p) of the ning agency for approval in accordance with
Act. section 1122 of the Act (42 U.S.C. 1320a–1) and
(h) Standard: Institutional planning. The implementing regulations.
HHA, under the direction of the governing (C) Whether the designated planning agen-
body, prepares an overall plan and a budget cy has approved or disapproved the proposed
that includes an annual operating budget capital expenditure if it was presented to
and capital expenditure plan. that agency.
(1) Annual operating budget. There is an an- (3) Preparation of plan and budget. The over-
nual operating budget that includes all an- all plan and budget is prepared under the di-
ticipated income and expenses related to rection of the governing body of the HHA by
items that would, under generally accepted a committee consisting of representatives of
accounting principles, be considered income the governing body, the administrative staff,
and expense items. However, it is not re- and the medical staff (if any) of the HHA.
quired that there be prepared, in connection (4) Annual review of plan and budget. The
with any budget, an item by item identifica- overall plan and budget is reviewed and up-
tion of the components of each type of an- dated at least annually by the committee re-
ticipated income or expense. ferred to in paragraph (i)(3) of this section
(2) Capital expenditure plan. (i) There is a under the direction of the governing body of
capital expenditure plan for at least a 3-year the HHA.
period, including the operating budget year.
The plan includes and identifies in detail the § 484.110 Condition of participation: Clinical
records.
anticipated sources of financing for, and the
objectives of, each anticipated expenditure The HHA must maintain a clinical record
of more than $600,000 for items that would containing past and current information for
under generally accepted accounting prin- every patient accepted by the HHA and re-
ciples, be considered capital items. In deter- ceiving home health services. Information
mining if a single capital expenditure ex- contained in the clinical record must be ac-
ceeds $600,000, the cost of studies, surveys, curate, adhere to current clinical record doc-
designs, plans, working drawings, specifica- umentation standards of practice, and be
tions, and other activities essential to the available to the physician(s) issuing orders
acquisition, improvement, modernization, for the home health plan of care, and appro-
expansion, or replacement of land, plant, priate HHA staff. This information may be
building, and equipment are included. Ex- maintained electronically.
penditures directly or indirectly related to (a) Standard: Contents of clinical record. The
capital expenditures, such as grading, pav- record must include:
ing, broker commissions, taxes assessed dur- (1) The patient’s current comprehensive as-
ing the construction period, and costs in- sessment, including all of the assessments
volved in demolishing or razing structures from the most recent home health admis-
on land are also included. Transactions that sion, clinical notes, plans of care, and physi-
are separated in time, but are components of cian orders;
an overall plan or patient care objective, are (2) All interventions, including medication
viewed in their entirety without regard to administration, treatments, and services,
their timing. Other costs related to capital and responses to those interventions;
expenditures include title fees, permit and li- (3) Goals in the patient’s plans of care and
cense fees, broker commissions, architect, the patient’s progress toward achieving
them;
legal, accounting, and appraisal fees; inter-

est, finance, or carrying charges on bonds, (4) Contact information for the patient, the
notes and other costs incurred for borrowing patient’s representative (if any), and the pa-
funds. tient’s primary caregiver(s);
180
(5) Contact information for the primary home health care or a related health care
care practitioner or other health care profes- program.
sional who will be responsible for providing (2) For individuals that begin employment
care and services to the patient after dis- with an HHA on or after July 13, 2017, a per-
charge from the HHA; and son who:
(6)(i) A completed discharge summary that (i) Is a licensed physician, a registered
is sent to the primary care practitioner or nurse, or holds an undergraduate degree; and
other health care professional who will be re- (ii) Has experience in health service admin-
sponsible for providing care and services to istration, with at least 1 year of supervisory
the patient after discharge from the HHA (if or administrative experience in home health
any) within 5 business days of the patient’s care or a related health care program.
discharge; or (b) Standard: Audiologist. A person who:
(ii) A completed transfer summary that is (1) Meets the education and experience re-
sent within 2 business days of a planned quirements for a Certificate of Clinical Com-
transfer, if the patient’s care will be imme- petence in audiology granted by the Amer-
diately continued in a health care facility; or ican Speech-Language-Hearing Association;
(iii) A completed transfer summary that is or
sent within 2 business days of becoming (2) Meets the educational requirements for
aware of an unplanned transfer, if the pa- certification and is in the process of accumu-
tient is still receiving care in a health care lating the supervised experience required for
facility at the time when the HHA becomes certification.
aware of the transfer. (c) Standard: Clinical manager. A person who
(b) Standard: Authentication. All entries is a licensed physician, physical therapist,
must be legible, clear, complete, and appro- speech-language pathologist, occupational
priately authenticated, dated, and timed. therapist, audiologist, social worker, or a
Authentication must include a signature and registered nurse.
a title (occupation), or a secured computer (d) Standard: Home health aide. A person
entry by a unique identifier, of a primary au- who meets the qualifications for home
thor who has reviewed and approved the health aides specified in section 1891(a)(3) of
entry. the Act and implemented at § 484.80.
(c) Standard: Retention of records. (1) Clin- (e) Standard: Licensed practical (vocational)
ical records must be retained for 5 years nurse. A person who has completed a prac-
after the discharge of the patient, unless tical (vocational) nursing program, is li-
state law stipulates a longer period of time. censed in the state where practicing, and
(2) The HHA’s policies must provide for re- who furnishes services under the supervision
tention of clinical records even if it discon- of a qualified registered nurse.
tinues operation. When an HHA discontinues (f) Standard: Occupational therapist. A per-
operation, it must inform the state agency son who—
where clinical records will be maintained. (1)(i) Is licensed or otherwise regulated, if
(d) Standard: Protection of records. The clin- applicable, as an occupational therapist by
ical record, its contents, and the information the state in which practicing, unless licen-
contained therein must be safeguarded sure does not apply;
against loss or unauthorized use. The HHA (ii) Graduated after successful completion
must be in compliance with the rules regard- of an occupational therapist education pro-
ing protected health information set out at gram accredited by the Accreditation Coun-
45 CFR parts 160 and 164. cil for Occupational Therapy Education
(e) Standard: Retrieval of clinical records. A (ACOTE) of the American Occupational
patient’s clinical record (whether hard copy Therapy Association, Inc. (AOTA), or suc-
or electronic form) must be made available cessor organizations of ACOTE; and
to a patient, free of charge, upon request at (iii) Is eligible to take, or has successfully
the next home visit, or within 4 business completed the entry-level certification ex-
days (whichever comes first). amination for occupational therapists devel-
oped and administered by the National Board
§ 484.115 Condition of participation: Per- for Certification in Occupational Therapy,
sonnel qualifications. Inc. (NBCOT).
HHA staff are required to meet the fol- (2) On or before December 31, 2009—
lowing standards: (i) Is licensed or otherwise regulated, if ap-
(a) Standard: Administrator, home health plicable, as an occupational therapist by the
agency. (1) For individuals that began em- state in which practicing; or
ployment with the HHA prior to January 13, (ii) When licensure or other regulation
2018, a person who: does not apply—
(i) Is a licensed physician; (A) Graduated after successful completion
(ii) Is a registered nurse; or of an occupational therapist education pro-

(iii) Has training and experience in health gram accredited by the accreditation Coun-
service administration and at least 1 year of cil for Occupational Therapy Education
supervisory administrative experience in (ACOTE) of the American Occupational
181
Therapy Association, Inc. (AOTA) or suc- (iii) Is eligible to take or successfully com-
cessor organizations of ACOTE; and pleted the entry-level certification examina-
(B) Is eligible to take, or has successfully tion for occupational therapy assistants de-
completed the entry-level certification ex- veloped and administered by the National
amination for occupational therapists devel- Board for Certification in Occupational
oped and administered by the National Board Therapy, Inc. (NBCOT).
for Certification in Occupational Therapy, (2) On or before December 31, 2009—
Inc., (NBCOT). (i) Is licensed or otherwise regulated as an
(3) On or before January 1, 2008— occupational therapy assistant, if applicable,
(i) Graduated after successful completion by the state in which practicing; or any
of an occupational therapy program accred- qualifications defined by the state in which
ited jointly by the Committee on Allied practicing, unless licensure does not apply;
Health Education and Accreditation of the or
American Medical Association and the (ii) Must meet both of the following:
American Occupational Therapy Associa- (A) Completed certification requirements
tion; or to practice as an occupational therapy as-
(ii) Is eligible for the National Registra- sistant established by a credentialing organi-
tion Examination of the American Occupa- zation approved by the American Occupa-
tional Therapy Association or the National tional Therapy Association.
Board for Certification in Occupational (B) After January 1, 2010, meets the re-
Therapy. quirements in paragraph (f)(1) of this sec-
(4) On or before December 31, 1977— tion.
(i) Had 2 years of appropriate experience as
(3) After December 31, 1977 and on or before
an occupational therapist; and
December 31, 2007—
(ii) Had achieved a satisfactory grade on an
(i) Completed certification requirements to
occupational therapist proficiency examina-
practice as an occupational therapy assist-
tion conducted, approved, or sponsored by
ant established by a credentialing organiza-
the U.S. Public Health Service.
tion approved by the American Occupational
(5) If educated outside the United States,
Therapy Association; or
must meet both of the following:
(i) Graduated after successful completion (ii) Completed the requirements to prac-
of an occupational therapist education pro- tice as an occupational therapy assistant ap-
gram accredited as substantially equivalent plicable in the state in which practicing.
to occupational therapist entry level edu- (4) On or before December 31, 1977—
cation in the United States by one of the fol- (i) Had 2 years of appropriate experience as
lowing: an occupational therapy assistant; and
(A) The Accreditation Council for Occupa- (ii) Had achieved a satisfactory grade on an
tional Therapy Education (ACOTE). occupational therapy assistant proficiency
(B) Successor organizations of ACOTE. examination conducted, approved, or spon-
(C) The World Federation of Occupational sored by the U.S. Public Health Service.
Therapists. (5) If educated outside the United States,
(D) A credentialing body approved by the on or after January 1, 2008—
American Occupational Therapy Associa- (i) Graduated after successful completion
tion. of an occupational therapy assistant edu-
(E) Successfully completed the entry level cation program that is accredited as sub-
certification examination for occupational stantially equivalent to occupational thera-
therapists developed and administered by the pist assistant entry level education in the
National Board for Certification in Occupa- United States by—
tional Therapy, Inc. (NBCOT). (A) The Accreditation Council for Occupa-
(ii) On or before December 31, 2009, is li- tional Therapy Education (ACOTE).
censed or otherwise regulated, if applicable, (B) Its successor organizations.
as an occupational therapist by the state in (C) The World Federation of Occupational
which practicing. Therapists.
(g) Standard: Occupational therapy assistant. (D) By a credentialing body approved by
A person who— the American Occupational Therapy Asso-
(1) Meets all of the following: ciation; and
(i) Is licensed or otherwise regulated, if ap- (E) Successfully completed the entry level
plicable, as an occupational therapy assist- certification examination for occupational
ant by the state in which practicing, unless therapy assistants developed and adminis-
licensure does apply. tered by the National Board for Certification
(ii) Graduated after successful completion in Occupational Therapy, Inc. (NBCOT).
of an occupational therapy assistant edu- (ii) [Reserved]
cation program accredited by the Accredita- (h) Standard: Physical therapist. A person
tion Council for Occupational Therapy Edu- who is licensed, if applicable, by the state in
cation, (ACOTE) of the American Occupa- which practicing, unless licensure does not
tional Therapy Association, Inc. (AOTA) or apply and meets one of the following require-
its successor organizations. ments:
182
(1)(i) Graduated after successful comple- physical therapy in which services were ren-
tion of a physical therapist education pro- dered under the order and direction of at-
gram approved by one of the following: tending and referring doctors of medicine or
(A) The Commission on Accreditation in osteopathy.
Physical Therapy Education (CAPTE). (7) If trained outside the United States be-
(B) Successor organizations of CAPTE. fore January 1, 2008, meets the following re-
(C) An education program outside the quirements:
United States determined to be substantially (i) Was graduated since 1928 from a phys-
equivalent to physical therapist entry level ical therapy curriculum approved in the
education in the United States by a creden- country in which the curriculum was located
tials evaluation organization approved by and in which there is a member organization
the American Physical Therapy Association of the World Confederation for Physical
or an organization identified in 8 CFR Therapy.
212.15(e) as it relates to physical therapists. (ii) Meets the requirements for member-
(ii) Passed an examination for physical ship in a member organization of the World
therapists approved by the state in which Confederation for Physical Therapy.
physical therapy services are provided. (i) Standard: Physical therapist assistant. A
(2) On or before December 31, 2009— person who is licensed, registered or certified
(i) Graduated after successful completion as a physical therapist assistant, if applica-
of a physical therapy curriculum approved ble, by the state in which practicing, unless
by the Commission on Accreditation in licensure does not apply and meets one of
Physical Therapy Education (CAPTE); or the following requirements:
(ii) Meets both of the following: (1)(i) Graduated from a physical therapist
(A) Graduated after successful completion assistant curriculum approved by the Com-
of an education program determined to be mission on Accreditation in Physical Ther-
substantially equivalent to physical thera- apy Education of the American Physical
pist entry level education in the United Therapy Association; or if educated outside
States by a credentials evaluation organiza- the United States or trained in the United
tion approved by the American Physical States military, graduated from an edu-
Therapy Association or identified in 8 CFR cation program determined to be substan-
212.15(e) as it relates to physical therapists. tially equivalent to physical therapist assist-
(B) Passed an examination for physical ant entry level education in the United
therapists approved by the state in which States by a credentials evaluation organiza-
physical therapy services are provided. tion approved by the American Physical
(3) Before January 1, 2008 graduated from a Therapy Association or identified at 8 CFR
physical therapy curriculum approved by one 212.15(e); and
of the following: (ii) Passed a national examination for
(i) The American Physical Therapy Asso- physical therapist assistants.
ciation. (2) On or before December 31, 2009, meets
(ii) The Committee on Allied Health Edu- one of the following:
cation and Accreditation of the American (i) Is licensed, or otherwise regulated in
Medical Association. the state in which practicing.
(iii) The Council on Medical Education of (ii) In states where licensure or other regu-
the American Medical Association and the lations do not apply, graduated before De-
American Physical Therapy Association. cember 31, 2009, from a 2-year college-level
(4) On or before December 31, 1977 was li- program approved by the American Physical
censed or qualified as a physical therapist Therapy Association and after January 1,
and meets both of the following: 2010, meets the requirements of paragraph
(i) Has 2 years of appropriate experience as (h)(1) of this section.
a physical therapist. (3) Before January 1, 2008, where licensure
(ii) Has achieved a satisfactory grade on a or other regulation does not apply, grad-
proficiency examination conducted, ap- uated from a 2-year college level program ap-
proved, or sponsored by the U.S. Public proved by the American Physical Therapy
Health Service. Association.
(5) Before January 1, 1966— (4) On or before December 31, 1977, was li-
(i) Was admitted to membership by the censed or qualified as a physical therapist
American Physical Therapy Association; assistant and has achieved a satisfactory
(ii) Was admitted to registration by the grade on a proficiency examination con-
American Registry of Physical Therapists; ducted, approved, or sponsored by the U.S.
or Public Health Service.
(iii) Graduated from a physical therapy (j) Standard: Physician. A person who meets
curriculum in a 4-year college or university the qualifications and conditions specified in
approved by a state department of education. section 1861(r) of the Act and implemented at
(6) Before January 1, 1966 was licensed or § 410.20(b) of this chapter.

registered, and before January 1, 1970, had 15 (k) Standard: Registered nurse. A graduate
years of fulltime experience in the treatment of an approved school of professional nursing
of illness or injury through the practice of who is licensed in the state where practicing.
183
§ 484.200 42 CFR Ch. IV (10–1–17 Edition)
(l) Standard: Social Work Assistant. A person the methodology used for the develop-
who provides services under the supervision ment of the payment rates, associated
of a qualified social worker and: adjustments, and related rules.
(1) Has a baccalaureate degree in social
work, psychology, sociology, or other field
related to social work, and has had at least § 484.202 Definitions.
1 year of social work experience in a health As used in this subpart—
care setting; or Case-mix index means a scale that
(2) Has 2 years of appropriate experience as
a social work assistant, and has achieved a measures the relative difference in re-
satisfactory grade on a proficiency examina- source intensity among different
tion conducted, approved, or sponsored by groups in the clinical model.
the U.S. Public Health Service, except that Discipline means one of the six home
the determinations of proficiency do not health disciplines covered under the
apply with respect to persons initially li- Medicare home health benefit (skilled
censed by a state or seeking initial qualifica-
tion as a social work assistant after Decem- nursing services, home health aide
ber 31, 1977. services, physical therapy services, oc-
(m) Standard: Social worker. A person who cupational therapy services, speech-
has a master’s or doctoral degree from a language pathology services, and med-
school of social work accredited by the Coun- ical social services).
cil on Social Work Education, and has 1 year
Furnishing Negative Pressure Wound
of social work experience in a health care
setting. Therapy (NPWT) using a disposable de-
(n) Standard: Speech-language pathologist. A vice means the application of a new ap-
person who has a master’s or doctoral degree plicable disposable device, as that term
in speech-language pathology, and who is defined in section 1834(s)(2) of the
meets either of the following requirements: Act, which includes the professional
(1) Is licensed as a speech-language pathol- services (specified by the assigned
ogist by the state in which the individual
furnishes such services; or
CPT® code) that are provided.
(2) In the case of an individual who fur- Home health market basket index
nishes services in a state which does not li- means an index that reflects changes
cense speech-language pathologists: over time in the prices of an appro-
(i) Has successfully completed 350 clock priate mix of goods and services in-
hours of supervised clinical practicum (or is cluded in home health services.
in the process of accumulating supervised
clinical experience); Rural area means, with respect to
(ii) Performed not less than 9 months of su- home health episodes ending on or
pervised full-time speech-language pathology after January 1, 2006, an area defined in
services after obtaining a master’s or doc- § 412.64(b)(1)(ii)(C) of this chapter.
toral degree in speech-language pathology or Urban area means, with respect to
a related field; and
home health episodes ending on or
(iii) Successfully completed a national ex-
amination in speech-language pathology ap- after January 1, 2006, an area defined in
proved by the Secretary. § 412.64(b)(1)(ii)(A) and (B) of this chap-
ter.
Subpart D [Reserved] [70 FR 68142, Nov. 9, 2005, as amended at 81
FR 76796, Nov. 3, 2016]
Subpart E—Prospective Payment
System for Home Health Agencies § 484.205 Basis of payment.
(a) Method of payment. An HHA re-
SOURCE: 65 FR 41212, July 3, 2000, unless ceives a national prospective 60-day
otherwise noted. episode payment of a predetermined
rate for a home health service pre-
§ 484.200 Basis and scope. viously paid on a reasonable cost basis
(a) Basis. This subpart implements (except the osteoporosis drug defined in
section 1895 of the Act, which provides section 1861(kk) of the Act) as of Au-
for the implementation of a prospec- gust 5, 1997. The national 60-day epi-
tive payment system (PPS) for HHAs sode payment is determined in accord-
for portions of cost reporting periods ance with § 484.215. The national pro-
occurring on or after October 1, 2000. spective 60-day episode payment is sub-

(b) Scope. This subpart sets forth the ject to the following adjustments and
framework for the HHA PPS, including additional payments:
184
(1) A low-utilization payment adjust- paid to an HHA at 50 percent of the

ment (LUPA) of a predetermined per- case-mix and wage adjusted 60-day epi-
visit rate as specified in § 484.230. sode rate. The residual final payment
(2) A partial episode payment (PEP) for subsequent episodes is paid at 50
adjustment due to an intervening event percent of the case-mix and wage ad-
defined as a beneficiary elected trans- justed 60-day episode rate. Split per-
fer or a discharge and return to the centage payments are made in accord-
same HHA during the 60-day episode, ance with requirements at § 409.43(c) of
that warrants a new 60-day episode this chapter.
payment during an existing 60-day epi- (c) Low-utilization payment. An HHA
sode, that initiates the start of a new receives a national 60-day episode pay-
60-day episode payment and a new phy- ment of a predetermined rate for home
sician certification of the new plan of health services previously paid on a
care. The PEP adjustment is deter- reasonable cost basis as of August 5,
mined in accordance with § 484.235. 1997, unless CMS determines at the end
(3) An outlier payment is determined of the 60-day episode that the HHA fur-
in accordance with § 484.240. nished minimal services to a patient
(b) Episode payment The national, during the 60-day episode. A low- utili-
standardized prospective 60-day episode zation payment adjustment is deter-
payment represents payment in full for mined in accordance with § 484.230.
all costs associated with furnishing (d) Partial episode payment adjustment.
home health services previously paid (1) An HHA receives a national 60-day
on a reasonable cost basis (except the
episode payment of a predetermined
osteoporosis drug listed in section
rate for home health services unless
1861(m) of the Act as defined in section
CMS determines an intervening event,
1861(kk) of the Act) as of August 5, 1997
defined as a beneficiary elected trans-
unless the national 60-day episode pay-
fer or discharge with goals met or no
ment is subject to a low-utilization
expectation of return to home health
payment adjustment set forth in
and the beneficiary returned to home
§ 484.230, a partial episode payment ad-
health during the 60-day episode, war-
justment set forth at § 484.235, or an ad-
rants a new 60-day episode for purposes
ditional outlier payment set forth in
of payment. A start of care OASIS as-
§ 484.240. All payments under this sys-
tem may be subject to a medical re- sessment and physician certification of
view adjustment reflecting beneficiary the new plan of care are required.
eligibility, medical necessity deter- (2) The PEP adjustment will not
minations, and HHRG assignment. apply in situations of transfers among
DME provided as a home health service HHAs of common ownership. Those sit-
as defined in section 1861(m) of the Act uations will be considered services pro-
continues to be paid the fee schedule vided under arrangement on behalf of
amount. Separate payment is made for the originating HHA by the receiving
‘‘furnishing NPWT using a disposable HHA with the common ownership in-
device,’’ as that term is defined in terest for the balance of the 60-day epi-
§ 484.202, which is not included in the sode. The common ownership exception
episode payment. to the transfer PEP adjustment does
(1) Split percentage payment for initial not apply if the beneficiary moves to a
episodes. The initial percentage pay- different MSA or Non-MSA during the
ment for initial episodes is paid to an 60-day episode before the transfer to
HHA at 60 percent of the case-mix and the receiving HHA. The transferring
wage adjusted 60-day episode rate. The HHA in situations of common owner-
residual final payment for initial epi- ship not only serves as a billing agent,
sodes is paid at 40 percent of the case- but must also exercise professional re-
mix and wage adjusted 60-day episode sponsibility over the arranged-for serv-
rate. Split percentage payments are ices in order for services provided
made in accordance with requirements under arrangements to be paid.
at § 409.43(c) of this chapter. (3) If the intervening event warrants
(2) Split percentage payment for subse- a new 60-day episode payment and a
quent episodes. The initial percentage new physician certification and a new
payment for subsequent episodes is plan of care, the initial HHA receives a
185
§ 484.210 42 CFR Ch. IV (10–1–17 Edition)
partial episode payment adjustment re- using data on the most recent available
flecting the length of time the patient audited cost reports, CMS determines
remained under its care. A partial epi- each HHA’s costs by summing its al-
sode payment adjustment is deter- lowable costs for the period. CMS de-
mined in accordance with § 484.235. termines the national mean cost per
(e) Outlier payment. An HHA receives visit.
a national 60-day episode payment of a (b) Determining HHA utilization. In
predetermined rate for a home health calculating the initial unadjusted na-
service, unless the imputed cost of the tional 60-day episode payment, CMS de-
60-day episode exceeds a threshold termines the national mean utilization
amount. The outlier payment is de- for each of the six disciplines using
fined to be a proportion of the imputed home health claims data.
costs beyond the threshold. An outlier (c) Use of the market basket index. CMS
payment is a payment in addition to uses the HHA market basket index to
the national 60-day episode payment. adjust the HHA cost data to reflect
The total of all outlier payments is cost increases occurring between Octo-
limited to no more than 2.5 percent of ber 1, 1996 through September 30, 2001.
total outlays under the HHA PPS. An (d) Calculation of the unadjusted na-
outlier payment is determined in ac- tional average prospective payment
cordance with § 484.240. amount for the 60-day episode. CMS cal-
[65 FR 41212, July 3, 2000, as amended at 72 culates the unadjusted national 60-day
FR 49878, Aug. 29, 2007; 80 FR 68717, Nov. 5, episode payment in the following man-
2015; 81 FR 76796, Nov. 3, 2016] ner:
(1) By computing the mean national
§ 484.210 Data used for the calculation
of the national prospective 60-day cost per visit.
episode payment. (2) By computing the national mean
utilization for each discipline.
To calculate the national prospective
60-day episode payment, CMS uses the (3) By multiplying the mean national
following: cost per visit by the national mean uti-
(a) Medicare cost data on the most lization summed in the aggregate for
recent audited cost report data avail- the six disciplines.
able. (4) By adding to the amount derived
(b) Utilization data based on Medi- in paragraph (d)(3) of this section,
care claims. amounts for nonroutine medical sup-
(c) An appropriate wage index to ad- plies, an OASIS adjustment for esti-
just for area wage differences. mated ongoing reporting costs, an
(d) The most recent projections of in- OASIS adjustment for the one time im-
creases in costs from the HHA market plementation costs associated with as-
basket index. sessment scheduling form changes and
(e) OASIS assessment data and other amounts for Part B therapies that
data that account for the relative re- could have been unbundled to Part B
source utilization for different HHA prior to October 1, 2000. The resulting
Medicare patient case-mix. An HHA amount is the unadjusted national 60-
must submit to CMS the OASIS data day episode rate.
described at § 484.55(b)(1) and (d)(1) in (e) Standardization of the data for vari-
order for CMS to administer the pay- ation in area wage levels and case-mix.
ment rate methodologies described in CMS standardizes—
§§ 484.215, 484.230 and 484.235. (1) The cost data described in para-
[65 FR 41212, July 3, 2000, as amended at 74
graph (a) of this section to remove the
FR 58134, Nov. 10, 2009] effects of geographic variation in wage
levels and variation in case-mix;
§ 484.215 Initial establishment of the (2) The cost data for geographic vari-
calculation of the national 60-day ation in wage levels using the hospital
episode payment. wage index; and
(a) Determining an HHA’s costs. In cal- (3) The cost data for HHA variation
culating the initial unadjusted na- in case-mix using the case-mix indices
tional 60-day episode payment applica- and other data that indicate HHA case-
ble for a service furnished by an HHA mix.
186
§ 484.220 Calculation of the adjusted submit home health quality data, as

national prospective 60-day episode specified by the Secretary, the
payment rate for case-mix and area unadjusted national prospective 60-day
wage levels. episode rate is equal to the rate for the
CMS adjusts the national prospective previous calendar year increased by the
60-day episode payment rate to account applicable home health market basket
for the following: index amount minus 2 percentage
(a) HHA case-mix using a case-mix points. Any reduction of the percent-
index to explain the relative resource age change will apply only to the cal-
utilization of different patients. To ad- endar year involved and will not be
dress changes to the case-mix that are taken into account in computing the
a result of changes in the coding or prospective payment amount for a sub-
classification of different units of serv- sequent calendar year.
ice that do not reflect real changes in
[80 FR 68717, Nov. 5, 2015]
case-mix, the national prospective 60-
day episode payment rate will be ad- § 484.230 Methodology used for the cal-
justed downward as follows: culation of the low-utilization pay-
(1) For CY 2008, the adjustment is 2.75 ment adjustment.
percent.
(2) For CY 2009 and CY 2010, the ad- An episode with four or fewer visits
justment is 2.75 percent in each year. is paid the national per-visit amount
(3) For CY 2011, the adjustment is 3.79 by discipline updated annually by the
percent. applicable market basket for each visit
(4) For CY 2012, the adjustment is 3.79 type. The national per-visit amount is
percent. determined by using cost data set forth
(5) For CY 2013, the adjustment is 1.32 in § 484.210(a) and adjusting by the ap-
percent. propriate wage index based on the site
(6) For CY 2016, CY 2017, and CY 2018, of service for the beneficiary. For 2008
the adjustment is 0.97 percent in each and subsequent calendar years, an
year. amount will be added to low-utilization
(b) Geographic differences in wage payment adjustments for low-utiliza-
levels using an appropriate wage index tion episodes that occur as the bene-
based on the site of service of the beneficiary’s only episode or initial episode
ficiary. in a sequence of adjacent episodes. For
purposes of the home health PPS, a se-
[72 FR 49879, Aug. 29, 2007, as amended at 80 quence of adjacent episodes for a bene-
FR 68717, Nov. 5, 2015] ficiary is a series of claims with no
§ 484.225 Annual update of the more than 60 days without home care
unadjusted national prospective 60- between the end of one episode, which
day episode payment rate. is the 60th day (except for episodes that
have been PEP-adjusted), and the be-
(a) CMS updates the unadjusted na-
ginning of the next episode.
tional 60-day episode payment rate on
a fiscal year basis (as defined in section [65 FR 41212, July 3, 2000, as amended at 72
1895(b)(1)(B) of the Act). FR 69879, Aug. 29, 2007; 80 FR 68717, Nov. 5,
(b) For 2007 and subsequent calendar 2015]
years, in accordance with section
1895(b)(3)(B)(v) of the Act, in the case of § 484.235 Methodology used for the cal-
a home health agency that submits culation of the partial episode pay-
ment adjustment.
home health quality data, as specified
by the Secretary, the unadjusted na- (a) CMS makes a PEP adjustment to
tional prospective 60-day episode rate the original 60-day episode payment
is equal to the rate for the previous that is interrupted by an intervening
calendar year increased by the applica- event described in § 484.205(d).
ble home health market basket index (b) The original 60-day episode pay-
amount. ment is adjusted to reflect the length
(c) For 2007 and subsequent calendar of time the beneficiary remained under
years, in accordance with section the care of the original HHA based on
1895(b)(3)(B)(v) of the Act, in the case of the first billable visit date through and
a home health agency that does not including the last billable visit date.
187
§ 484.240 42 CFR Ch. IV (10–1–17 Edition)
(c) The partial episode payment is reporting requirements of section

calculated by determining the actual 1895(b)(3)(B)(v) of the Act.
days served by the original HHA as a (b) Patient count. An HHA that has
proportion of 60 multiplied by the ini- less than 60 eligible unique HHCAHPS
tial 60-day episode payment. patients annually must annually sub-
mit to CMS their total HHCAHPS pa-
§ 484.240 Methodology used for the cal- tient count to CMS to be exempt from
culation of the outlier payment. the HHCAHPS reporting requirements
(a) CMS makes an outlier payment for a calendar year period.
for an episode whose estimated cost ex- (c) Survey requirements. An HHA must
ceeds a threshold amount for each contract with an approved, inde-
case-mix group. pendent HHCAHPS survey vendor to
(b) The outlier threshold for each administer the HHCAHPS Survey on
case-mix group is the episode payment its behalf.
amount for that group, or the PEP ad- (1) CMS approves an HHCAHPS sur-
justment amount for the episode, plus vey vendor if such applicant has been
a fixed dollar loss amount that is the in business for a minimum of 3 years
same for all case-mix groups. and has conducted surveys of individ-
(c) The outlier payment is a propor- uals and samples for at least 2 years.
tion of the amount of estimated cost (i) For HHCAHPS, a ‘‘survey of indi-
beyond the threshold. viduals’’ is defined as the collection of
(d) CMS imputes the cost for each data from at least 600 individuals se-
episode by multiplying the national lected by statistical sampling methods
per-15 minute unit amount of each dis- and the data collected are used for sta-
cipline by the number of 15 minute tistical purposes.
units in the discipline and computing (ii) All applicants that meet these re-
the total imputed cost for all dis- quirements will be approved by CMS.
ciplines. (2) No organization, firm, or business
(e) The fixed dollar loss amount and that owns, operates, or provides staff-
the loss sharing proportion are chosen ing for a HHA is permitted to admin-
so that the estimated total outlier pay- ister its own Home Health Care CAHPS
ment is no more than 2.5 percent of (HHCAHPS) Survey or administer the
total payment under home health PPS. survey on behalf of any other HHA in
(f) The total amount of outlier pay- the capacity as an HHCAHPS survey
ments to a specific home health agency vendor. Such organizations will not be
for a year may not exceed an amount approved by CMS as HHCAHPS survey
equal to 10 percent of the total pay- vendors.
ments to the specific agency under (3) Approved HHCAHPS survey ven-
home health PPS for the year. dors must fully comply with all
HHCAHPS oversight activities, includ-
[65 FR 41212, July 3, 2000, as amended at 72 ing allowing CMS and its HHCAHPS
FR 69879, Aug. 29, 2007; 80 FR 68717, Nov. 5,
2015; 81 FR 76796, Nov. 3, 2016]
program team to perform site visits at
the vendors’ company locations.
§ 484.245 [Reserved] [76 FR 68606, Nov. 4, 2011, as amended at 77
FR 67164, Nov. 8, 2012; 79 FR 66118, Nov. 6,
§ 484.250 Patient assessment data. 2014; 80 FR 68718, Nov. 5, 2015]
(a) Data submission. An HHA must
submit the following data to CMS: § 484.260 Limitation on review.
(1) The OASIS data described at An HHA is not entitled to judicial or
§ 484.55(b)(1) and (d)(1) for CMS to ad- administrative review under sections
minister the payment rate methodolo- 1869 or 1878 of the Act, or otherwise,
gies described in §§ 484.215, 484.230, and with regard to the establishment of the
484.235, and to meet the quality report- payment unit, including the national
ing requirements of section 60-day prospective episode payment
1895(b)(3)(B)(v) of the Act. rate, adjustments and outlier pay-
(2) The Home Health Care CAHPS ments. An HHA is not entitled to the
survey data for CMS to administer the review regarding the establishment of
payment rate methodologies described the transition period, definition and
in § 484.225(c), and to meet the quality application of the unit of payments,
188
the computation of initial standard (1) That has or have a current Medi-
prospective payment amounts, the es- care certification; and,
tablishment of the adjustment for (2) Is or are being paid by CMS for
outliers, and the establishment of case- home health care delivered within any
mix and area wage adjustment factors. of the states specified in § 484.310.
Home health prospective payment sys-
§ 484.265 Additional payment. tem (HH PPS) refers to the basis of pay-
QIO photocopy and mailing costs. An ment for home health agencies as set
additional payment is made to a home forth in §§ 484.200 through 484.245.
health agency in accordance with Larger-volume cohort means the group
§ 476.78 of this chapter for the costs of of competing home health agencies
photocopying and mailing medical within the boundaries of selected
records requested by a QIO. states that are participating in
HHCAHPs in accordance with § 484.250.
[68 FR 67960, Dec. 5, 2003] Linear exchange function is the means
to translate a competing HHA’s Total
Subpart F—Home Health Value- Performance Score into a value-based
Based Purchasing (HHVBP) payment adjustment percentage.
Model Components for Com- New measures means those measures
peting Home Health Agencies to be reported by competing HHAs
Within State Boundaries under the HHVBP Model that are not
otherwise reported by Medicare-cer-
tified HHAs to CMS and were identified
to fill gaps to cover National Quality
otherwise noted.
Strategy Domains not completely cov-
§ 484.300 Basis and scope of subpart. ered by existing measures in the home
health setting.
This subpart is established under sec- Payment adjustment means the
tions 1102, 1115A, and 1871 of the Act (42 amount by which a competing HHA’s
U.S.C. 1315a), which authorizes the Sec- final claim payment amount under the
retary to issue regulations to operate HH PPS is changed in accordance with
the Medicare program and test innova- the methodology described in § 484.325.
tive payment and service delivery mod- Performance period means the time
els to improve coordination, quality, period during which data are collected
and efficiency of health care services for the purpose of calculating a com-
furnished under Title XVIII. peting HHA’s performance on meas-
ures.
§ 484.305 Definitions.
Selected state(s) means those nine
As used in this subpart— states that were randomly selected to
Applicable measure means a measure compete/participate in the HHVBP
for which the competing HHA has pro- Model via a computer algorithm de-
vided 20 home health episodes of care signed for random selection and identi-
per year. fied at § 484.310(b).
Applicable percent means a maximum Smaller-volume cohort means the
upward or downward adjustment for a group of competing home health agen-
given performance year, not to exceed cies within the boundaries of selected
the following: states that are exempt from participa-
(1) For CY 2018, 3-percent. tion in HHCAHPs in accordance with
(2) For CY 2019, 5-percent. § 484.250.
(3) For CY 2020, 6-percent. Total Performance Score means the nu-
(4) For CY 2021, 7-percent. meric score ranging from 0 to 100
(5) For CY 2022, 8-percent. awarded to each competing HHA based
Benchmark refers to the mean of the on its performance under the HHVBP
top decile of Medicare-certified HHA Model.
performance on the specified quality Value-based purchasing means meas-
measure during the baseline period, uring, reporting, and rewarding excel-
calculated for each state. lence in health care delivery that takes
Competing home health agency or agen- into consideration quality, efficiency,
cies means an agency or agencies: and alignment of incentives. Effective
189
§ 484.310 42 CFR Ch. IV (10–1–17 Edition)
health care services and high performance on each of the applicable
forming health care providers may be measures excluding the New Measures.
rewarded with improved reputations (b) CMS will award points to the
through public reporting, enhanced competing home health agency for re-
payments through differential reim- porting on each of the New Measures
bursements, and increased market worth up to ten percent of the Total
share through purchaser, payer, and/or Performance Score.
consumer selection. (c) CMS will sum all points awarded
for each applicable measure excluding
FR 76796, Nov. 3, 2016] the New Measures weighted equally at
the individual measure level, to cal-
§ 484.310 Applicability of the Home culate a value worth 90-percent of the
Health Value-Based Purchasing Total Performance Score.
(HHVBP) Model. (d) The sum of the points awarded to
(a) General rule. The HHVBP Model a competing HHA for each applicable
applies to all Medicare-certified home measure and the points awarded to a
health agencies (HHAs) in selected competing HHA for reporting data on
states. each New Measure is the competing
(b) Selected states. Nine states have HHA’s Total Performance Score for the
been selected in accordance with CMS’s calendar year.
selection methodology. All Medicare- [80 FR 68718, Nov. 5, 2015, as amended at 81
certified HHAs that provide services in FR 76796, Nov. 3, 2016]
Massachusetts, Maryland, North Caro-
lina, Florida, Washington, Arizona, § 484.325 Payments for home health
Iowa, Nebraska, and Tennessee will be services under Home Health Value-
Based Purchasing (HHVBP) Model.
required to compete in this model.
CMS will determine a payment ad-
§ 484.315 Data reporting for measures justment up to the maximum applica-
and evaluation under the Home ble percentage, upward or downward,
Health Value-Based Purchasing under the HHVBP Model for each com-
(HHVBP) Model. peting home health agency based on
(a) Competing home health agencies the agency’s Total Performance Score
will be evaluated using a set of quality using a linear exchange function. Pay-
measures. ment adjustments made under the
(b) Competing home health agencies HHVBP Model will be calculated as a
in selected states will be required to re- percentage of otherwise-applicable pay-
port information on New Measures, as ments for home health services pro-
determined appropriate by the Sec- vided under section 1895 of the Act (42
retary, to CMS in the form, manner, U.S.C. 1395fff).
and at a time specified by the Sec-
retary. § 484.330 Process for determining and
applying the value-based payment
(c) Competing home health agencies adjustment under the Home Health
in selected states will be required to Value-Based Purchasing (HHVBP)
collect and report such information as Model.
the Secretary determines is necessary
(a) General. Competing home health
for purposes of monitoring and evalu-
agencies will be ranked within the
ating the HHVBP Model under section
larger-volume and smaller-volume co-
1115A(b)(4) of the Act (42 U.S.C. 1315a).
horts in selected states based on the
[80 FR 68718, Nov. 5, 2015, as amended at 81 performance standards that apply to
FR 76796, Nov. 3, 2016] the HHVBP Model for the baseline
year, and CMS will make value-based
§ 484.320 Calculation of the Total Per- payment adjustments to the competing
formance Score. HHAs as specified in this section.
A competing home health agency’s (b) Calculation of the value-based pay-
Total Performance Score for a model ment adjustment amount. The value-
year is calculated as follows: based payment adjustment amount is

(a) CMS will award points to the calculated by multiplying the Home
competing home health agency for per- Health Prospective Payment final
190
claim payment amount as calculated (4) Scope of review for recalculation. In

in accordance with § 484.205 by the pay- conducting the recalculation, CMS will
ment adjustment percentage. review the applicable measures and
(c) Calculation of the payment adjust- performance scores, the evidence and
ment percentage. The payment adjust- findings upon which the determination
ment percentage is calculated as the was based, and any additional docu-
product of: The applicable percent as mentary evidence submitted by the
defined in § 484.320, the competing home health agency. CMS may also re-
HHA’s Total Performance Score di- view any other evidence it believes to
vided by 100, and the linear exchange be relevant to the recalculation.
function slope. (5) Recalculation decision. CMS will
issue a written notification of findings.
§ 484.335 Appeals process for the Home A recalculation decision is subject to
Health Value-Based Purchasing the request for reconsideration process
(HHVBP) Model. in accordance with paragraph (b) of
(a) Requests for recalculation—(1) Mat- this section.
ters for recalculation. Subject to the (b) Requests for reconsideration—(1)
limitations on review under section Matters for reconsideration. A home
1115A of the Act, a HHA may submit a health agency may request reconsider-
request for recalculation under this ation of the recalculation of its annual
section if it wishes to dispute the cal- total performance score and payment
culation of the following: adjustment percentage following a de-
(i) Interim performance scores. cision on the home health agency’s re-
calculation request submitted under
(ii) Annual total performance scores.
paragraph (a) of this section, or the de-
(iii) Application of the formula to cision to deny the recalculation re-
calculate annual payment adjustment quest submitted under paragraph (a) of
percentages. this section.
(2) Time for filing a request for recal- (2) Time for filing a request for recon-
culation. A recalculation request must sideration. The request for reconsider-
be submitted in writing within 15 cal- ation must be submitted via the
endar days after CMS posts the HHA- HHVBP Secure Portal within 15 cal-
specific information on the HHVBP Se- endar days from CMS’ notification to
cure Portal, in a time and manner the HHA contact of the outcome of the
specified by CMS. recalculation process.
(3) Content of request. (i) The pro- (3) Content of request. (i) The name of
vider’s name, address associated with the HHA, address associated with the
the services delivered, and CMS Certifi- services delivered, and CMS Certifi-
cation Number (CCN). cation Number (CCN).
(ii) The basis for requesting recal- (ii) The basis for requesting reconsid-
culation to include the specific quality eration to include the specific quality
measure data that the HHA believes is measure data that the HHA believes is
inaccurate or the calculation the HHA inaccurate or the calculation the HHA
believes is incorrect. believes is incorrect.
(iii) Contact information for a person (iii) Contact information for a person
at the HHA with whom CMS or its at the HHA with whom CMS or its
agent can communicate about this reagent can communicate about this re-
quest, including name, email address, quest, including name, email address,
telephone number, and mailing address telephone number, and mailing address
(must include physical address, not (must include physical address, not
just a post office box). just a post office box).
(iv) The HHA may include in the re- (iv) The HHA may include in the re-
quest for recalculation additional doc- quest for reconsideration additional
umentary evidence that CMS should documentary evidence that CMS
consider. Such documents may not in- should consider. Such documents may
clude data that was to have been filed not include data that was to have been
by the applicable data submission filed by the applicable data submission

deadline, but may include evidence of deadline, but may include evidence of
timely submission. timely submission.
191
Pt. 485 42 CFR Ch. IV (10–1–17 Edition)
(4) Scope of review for reconsideration. 485.610 Condition of participation: Status

In conducting the reconsideration re- and location.
view, CMS will review the applicable 485.612 Condition of participation: Compli-
ance with hospital requirements at the
measures and performance scores, the
time of application.
evidence and findings upon which the 485.616 Condition of participation: Agree-
determination was based, and any addi- ments.
tional documentary evidence sub- 485.618 Condition of participation: Emer-
mitted by the HHA. CMS may also re- gency services.
view any other evidence it believes to 485.620 Condition of participation: Number
be relevant to the reconsideration. The of beds and length of stay.
HHA must prove its case by a prepon- 485.623 Condition of participation: Physical
derance of the evidence with respect to plant and environment.
485.625 Condition of participation: Emer-
issues of fact. gency preparedness.
(5) Reconsideration decision. CMS re- 485.627 Condition of participation: Organiza-
consideration officials will issue a tional structure.
written determination. 485.631 Condition of participation: Staffing
and staff responsibilities.
[81 FR 76796, Nov. 3, 2016]
485.635 Condition of participation: Provision
of services.
PART 485—CONDITIONS OF PAR- 485.638 Condition of participation: Clinical
TICIPATION: SPECIALIZED PRO- records.
485.639 Condition of participation: Surgical
VIDERS services.
485.641 Condition of participation: Periodic
Subpart A [Reserved] evaluation and quality assurance review.
485.643 Condition of participation: Organ,
Subpart B—Conditions of Participation: tissue, and eye procurement.
Comprehensive Outpatient Rehabilita- 485.645 Special requirements for CAH pro-
tion Facilities viders of long-term care services
(‘‘swing-beds’’).
Sec. 485.647 Condition of participation: psy-
485.50 Basis and scope. chiatric and rehabilitation distinct part
485.51 Definition. units.
485.54 Condition of participation: Compli-
ance with State and local laws. Subpart G [Reserved]
485.56 Condition of participation: Governing
body and administration. Subpart H—Conditions of Participation for
485.58 Condition of participation: Com- Clinics, Rehabilitation Agencies, and
prehensive rehabilitation program. Public Health Agencies as Providers of
485.60 Condition of participation: Clinical Outpatient Physical Therapy and
records.
Speech-Language Pathology Services
485.62 Condition of participation: Physical
environment. 485.701 Basis and scope.
485.64 [Reserved] 485.703 Definitions.
485.66 Condition of participation: Utiliza- 485.705 Personnel qualifications.
tion review plan. 485.707 Condition of participation: Compli-
485.68 Condition of participation: Emer- ance with Federal, State, and local laws.
gency preparedness. 485.709 Condition of participation: Adminis-
485.70 Personnel qualifications. trative management.
485.74 Appeal rights. 485.711 Condition of participation: Plan of
care and physician involvement.
Subparts C–E [Reserved] 485.713 Condition of participation: Physical
therapy services.
Subpart F—Conditions of Participation: 485.715 Condition of participation: Speech
Critical Access Hospitals (CAHs) pathology services.
485.717 Condition of participation: Rehabili-
485.601 Basis and scope. tation program.
485.603 Rural health network. 485.719 Condition of participation: Arrange-
485.604 Personnel qualifications. ments for physical therapy and speech
485.606 Designation and certification of pathology services to be performed by
CAHs. other than salaried organization per-

485.608 Condition of participation: Compli- sonnel.
ance with Federal, State, and local laws 485.721 Condition of participation: Clinical
and regulations. records.
192
485.723 Condition of participation: Physical prehensive outpatient rehabilitation facil-
environment. ity’’, ‘‘CORF’’, or ‘‘facility’’ means a
485.725 Condition of participation: Infection nonresidential facility that—
control.
485.727 Condition of participation: Emer- (a) Is established and operated exclu-
gency preparedness. sively for the purpose of providing di-
485.729 Condition of participation: Program agnostic, therapeutic, and restorative
evaluation. services to outpatients for the rehabili-
tation of injured, disabled, or sick per-
Subpart I [Reserved] sons, at a single fixed location, by or
under the supervision of a physician
Subpart J—Conditions of Participation:
except as provided in paragraph (c) of
Community Mental Health Centers
this section;
(CMHCs)
(b) Meets all the requirements of this
485.900 Basis and scope. subpart.
485.902 Definitions. (c) Exception. May provide influenza,
485.904 Condition of participation: Per-
pneumococcal and Hepatitis B vaccines
sonnel qualifications.
485.910 Condition of participation: Client provided the applicable conditions of
rights. coverage under § 410.58 and § 410.63 of
485.914 Condition of participation: Admis- this chapter are met.
sion, initial evaluation, comprehensive
assessment, and discharge or transfer of [48 FR 56293, Dec. 15, 1982, as amended at 72
the client. FR 66408, Nov. 27, 2007]
485.916 Condition of participation: Treat-
ment team, person-centered active treat- § 485.54 Condition of participation:
ment plan, and coordination of services. Compliance with State and local
485.917 Condition of participation: Quality laws.
assessment and performance improve- The facility and all personnel who
ment. provide services must be in compliance
485.918 Condition of participation: Organiza-
tion, governance, administration of serv-
with applicable State and local laws
ices, and partial hospitalization services. and regulations.
485.920 Condition of participation: Emer- (a) Standard: Licensure of facility. If
gency preparedness. State or local law provides for licens-
AUTHORITY: Secs. 1102 and 1871 of the Social ing, the facility must be currently li-
Security Act (42 U.S.C. 1302 and 1395(hh)). censed or approved as meeting the
standards established for licensure.
SOURCE: 48 FR 56293, Dec. 15, 1982, unless
otherwise noted. Redesignated at 50 FR 33034, (b) Standard: Licensure of personnel.
Aug. 16, 1985. Personnel that provide service must be
licensed, certified, or registered in ac-
Subpart A [Reserved] cordance with applicable State and
local laws.
Subpart B—Conditions of Partici- § 485.56 Condition of participation:
pation: Comprehensive Out- Governing body and administra-
patient Rehabilitation Facili- tion.
ties The facility must have a governing
body that assumes full legal responsi-
§ 485.50 Basis and scope. bility for establishing and imple-
This subpart sets forth the condi- menting policies regarding the man-
tions that facilities must meet to be agement and operation of the facility.
certified as comprehensive outpatient (a) Standard: Disclosure of ownership.
rehabilitation facilities (CORFs) under The facility must comply with the pro-
section 1861(cc)(2) of the Social Secu- visions of part 420, subpart C of this
rity Act and be accepted for participa- chapter that require health care pro-
tion in Medicare in accordance with viders and fiscal agents to disclose cer-
part 489 of this chapter. tain information about ownership and
control.
§ 485.51 Definition. (b) Standard: Administrator. The gov-

As used in this subpart, unless the erning body must appoint an adminis-
context indicates otherwise, ‘‘com- trator who—
193
§ 485.56 42 CFR Ch. IV (10–1–17 Edition)
(1) Is responsible for the overall man- (3) Rules for the storage, handling,
agement of the facility under the au- and administration of drugs and
thority delegated by the governing biologicals.
body; (4) Criteria for patient admission,
(2) Implements and enforces the fa- continuing care, and discharge.
cility’s policies and procedures; (5) Procedures for preparing and
(3) Designates, in writing, an indi- maintaining clinical records on all pa-
vidual who, in the absence of the ad- tients.
ministrator, acts on behalf of the ad- (6) A procedure for explaining to the
ministrator; and patient and the patient’s family the ex-
(4) Retains professional and adminis- tent and purpose of the services to be
trative responsibility for all personnel provided.
providing facility services. (7) A procedure to assist the referring
(c) Standard: Group of professional per- physician in locating another level of
sonnel. The facility must have a group care for—patients whose treatment has
of professional personnel associated terminated and who are discharged.
with the facility that— (8) A requirement that patients ac-
(1) Develops and periodically reviews cepted by the facility must be under
policies to govern the services provided the care of a physician.
by the facility; and (9) A requirement that there be a
(2) Consists of at least one physician plan of treatment established by a phy-
and one professional representing each sician for each patient.
of the services provided by the facility. (10) A procedure to ensure that the
group of professional personnel reviews
(d) Standard: Institutional budget plan.
and takes appropriate action on rec-
The facility must have an institutional
ommendations from the utilization re-
budget plan that meets the following
view committee regarding patient care
conditions:
policies.
(1) It is prepared, under the direction
(f) Standard: Delegation of authority.
of the governing body, by a committee
The responsibility for overall adminis-
consisting of representatives of the
tration, management, and operation
governing body and the administrative
must be retained by the facility itself
staff.
and not delegated to others.
(2) It provides for— (1) The facility may enter into a con-
(i) An annual operating budget pre- tract for purposes of assistance in fi-
pared according to generally accepted nancial management and may delegate
accounting principles; to others the following and similar
(ii) A 3-year capital expenditure plan services:
if expenditures in excess of $100,000 are (i) Bookkeeping.
anticipated, for that period, for the ac- (ii) Assistance in the development of
quisition of land; the improvement of procedures for billing and accounting
land, buildings, and equipment; and the systems.
replacement, modernization, and ex- (iii) Assistance in the development of
pansion of buildings and equipment; an operating budget.
and (iv) Purchase of supplies in bulk
(iii) Annual review and updating by form.
the governing body. (v) The preparation of financial
(e) Standard: Patient care policies. The statements.
facility must have written patient care (2) When the services listed in para-
policies that govern the services it fur- graph (f)(1) of this section are dele-
nishes. The patient care policies must gated, a contract must be in effect and:
include the following: (i) May not be for a term of more
(1) A description of the services the than 5 years;
facility furnishes through employees (ii) Must be subject to termination
and those furnished under arrange- within 60 days of written notice by ei-
ments. ther party;
(2) Rules for and personnel respon- (iii) Must contain a clause requiring
sibilities in handling medical emer- renegotiation of any provision that
gencies. CMS finds to be in contravention to
194
any new, revised or amended Federal (2) It must be promptly evaluated

regulation or law; after changes in the patient’s condition
(iv) Must state that only the facility and revised when necessary.
may bill the Medicare program; and (3) It must, if appropriate, be devel-
(v) May not include clauses that oped in consultation with the facility
state or imply that the contractor has physician and the appropriate facility
power and authority to act on behalf of professional personnel.
the facility, or clauses that give the (4) It must be reviewed at least every
contractor rights, duties, discretions, 60 days by a facility physician who,
or responsibilities that enable it to dic- when appropriate, consults with the
tate the administration, mangement, professional personnel providing serv-
or operations of the facility. ices. The results of this review must be
communicated to the patient’s refer-
§ 485.58 Condition of participation: ring physician for concurrence before
Comprehensive rehabilitation pro- treatment is continued or discon-
gram. tinued.
The facility must provide a coordi- (5) It must be revised if the com-
nated rehabilitation program that in- prehensive reassessment of the pa-
cludes, at a minimum, physicians’ serv- tient’s status or the results of the pa-
ices, physical therapy services, and so- tient case review conference indicate
cial or psychological services. These the need for revision.
services must be furnished by per- (c) Standard: Coordination of services.
sonnel that meet the qualifications set The facility must designate, in writing,
forth in §§ 485.70 and 484.4 of this chap- a qualified professional to ensure that
ter and must be consistent with the professional personnel coordinate their
plan of treatment and the results of related activities and exchange infor-
comprehensive patient assessments. mation about each patient under their
(a) Standard: Physician services. (1) A care. Mechanisms to assist in the co-
facility physician must be present in ordination of services must include—
the facility for a sufficient time to— (1) Providing to all personnel associ-
(i) Provide, in accordance with ac- ated with the facility, a schedule indi-
cepted principles of medical practice, cating the frequency and type of serv-
medical direction, medical care services provided at the facility;
ices, consultation, and medical super- (2) A procedure for communicating to
vision of nonphysician staff; all patient care personnel pertinent in-
(ii) Establish the plan of treatment formation concerning significant
in cases where a plan has not been es- changes in the patient’s status;
tablished by the referring physician; (3) Periodic clinical record entries,
(iii) Assist in establishing and imple- noting at least the patient’s status in
menting the facility’s patient care relationship to goal attainment; and
policies; and (4) Scheduling patient case review
(iv) Participate in plan of treatment conferences for purposes of deter-
reviews, patient case review con- mining appropriateness of treatment,
ferences, comprehensive patient assess- when indicated by the results of the
ment and reassessments, and utiliza- initial comprehensive patient assess-
tion review. ment, reassessment(s), the rec-
(2) The facility must provide for ommendation of the facility physician
emergency physician services during (or other physician who established the
the facility operating hours. plan of treatment), or upon the rec-
(b) Standard: Plan of treatment. For ommendation of one of the profes-
each patient, a physician must estab- sionals providing services.
lish a plan of treatment before the fa- (d) Standard: Provision of services. (1)
cility initiates treatment. The plan of All patients must be referred to the fa-
treatment must meet the following re- cility by a physician who provides the
quirements: following information to the facility
(1) It must delineate anticipated before treatment is initiated:
goals and specify the type, amount, fre- (i) The patient’s significant medical
quency and duration of services to be history.
provided. (ii) Current medical findings.
195
§ 485.60 42 CFR Ch. IV (10–1–17 Edition)
(iii) Diagnosis(es) and contraindication, a single home environment eval-

tions to any treatment modality. uation is covered if there is a need to
(iv) Rehabilitation goals, if deter- evaluate the potential impact of the
mined. home environment on the rehabilita-
(2) Services may be provided by facil- tion goals. The single home environ-
ity employees or by others under ar- ment evaluation requires the presence
rangements made by the facility. of the patient and the physical thera-
(3) The facility must have on its pist, occupational therapist, or speech-
premises the necessary equipment to language pathologist, as appropriate.
implement the plan of treatment and (f) Standard: Patient assessment. Each
sufficient space to allow adequate care. qualified professional involved in the
(4) The services must be furnished by patient’s care, as specified in the plan
personnel that meet the qualifications of treatment, must—
of § 485.70 and the number of qualified (1) Carry out an initial patient as-
personnel must be adequate for the vol- sessment; and
ume and diversity of services offered. (2) In order to identify whether or
Personnel that do not meet the quali- not the current plan of treatment is
fications specified in § 485.70 may be appropriate, perform a patient reas-
used by the facility in assisting quali- sessment after significant changes in
fied staff. When a qualified individual the patient’s status.
is assisted by these personnel, the (g) Standard: Laboratory services. (1) If
qualified individual must be on the the facility provides its own laboratory
premises, and must instruct these per- services, the services must meet the
sonnel in appropriate patient care serv- applicable requirements for labora-
ice techniques and retain responsibility tories specified in part 493 of this chap-
for their activities. ter.
(5) A qualified professional must ini- (2) If the facility chooses to refer
tiate and coordinate the appropriate specimens for laboratory testing, the
portions of the plan of treatment, mon- referral laboratory must be certified in
itor the patient’s progress, and rec- the appropriate specialties and sub-
ommend changes, in the plan, if nec- specialties of services in accordance
essary. with the requirements of part 493 of
(6) A qualified professional rep- this chapter.
resenting each service made available [48 FR 56293, Dec. 15, 1982, as amended at 56
at the facility must be either on the FR 8852, Mar. 1, 1991; 57 FR 7137, Feb. 28, 1992;
premises of the facility or must be 73 FR 69941, Nov. 19, 2008]
available through direct telecommuni-
EFFECTIVE DATE NOTE: At 82 FR 4591, Jan.
cation for consultation and assistance
13, 2017, § 485.58 introductory text was amend-
during the facility’s operating hours. ed by removing ‘‘and 484.4’’ and adding in its
At least one qualified professional place ‘‘and 484.115’’, effective July 13, 2017. At
must be on the premises during the fa- 82 FR 31729, July 10, 2017, this amendment
cility’s operating hours. was delayed until Jan. 13, 2018.
(7) All services must be provided con-
sistent with accepted professional § 485.60 Condition of participation:
standards and practice. Clinical records.
(e) Standard: Scope and site of serv- The facility must maintain clinical
ices—(1) Basic requirements. The facility records on all patients in accordance
must provide all the CORF services re- with accepted professional standards
quired in the plan of treatment and, ex- and practice. The clinical records must
cept as provided in paragraph (e)(2) of be completely, promptly, and accu-
this section, must provide the services rately documented, readily accessible,
on its premises. and systematically organized to facili-
(2) Exceptions. Physical therapy, oc- tate retrieval and compilation of infor-
cupational therapy, and speech-lan- mation.
guage pathology services may be fur- (a) Standard: Content. Each clinical
nished away from the premises of the record must contain sufficient infor-
CORF including the individual’s home mation to identify the patient clearly
when payment is not otherwise made and to justify the diagnosis and treat-
under Title XVIII of the Act. In addi- ment. Entries in the clinical record
196
must be made as frequently as is nec- ways) must meet the following require-
essary to insure effective treatment ments:
and must be signed by personnel pro- (1) Applicable Federal, State, and
viding services. All entries made by as- local building, fire, and safety codes
sistant level personnel must be must be met.
countersigned by the corresponding (2) Fire extinguishers must be easily
professional. Documentation on each accessible and fire regulations must be
patient must be consolidated into one prominently posted.
clinical record that must contain— (3) A fire alarm system with local (in-
(1) The initial assessment and subse- house) capability must be functional,
quent reassessments of the patient’s and where power is generated by elec-
needs; tricity, an alternate power source with
(2) Current plan of treatment; automatic triggering must be present.
(3) Identification data and consent or (4) Lights, supported by an emer-
authorization forms; gency power source, must be placed at
(4) Pertinent medical history, past exits.
and present; (5) A sufficient number of staff to
(5) A report of pertinent physical ex- evacuate patients during a disaster
aminations if any; must be on the premises of the facility
(6) Progress notes or other docu- whenever patients are being treated.
mentation that reflect patient reaction (6) Lighting must be sufficient to
to treatment, tests, or injury, or the carry out services safely; room tem-
need to change the established plan of perature must be maintained at com-
treatment; and fortable levels; and ventilation through
(7) Upon discharge, a discharge sum- windows, mechanical means, or a com-
mary including patient status relative bination of both must be provided.
to goal achievement, prognosis, and fu- (7) Safe and sufficient space must be
ture treatment considerations. available for the scope of services of-
(b) Standard: Protection of clinical fered.
record information. The facility must (b) Standard: Sanitary environment.
safeguard clinical record information The facility must maintain a sanitary
against loss, destruction, or unauthor- environment and establish a program
ized use. The facility must have proce- to identify, investigate, prevent, and
dures that govern the use and removal control the cause of patient infections.
of records and the conditions for re- (1) The facility must establish writ-
lease of information. The facility must ten policies and procedures designed to
obtain the patient’s written consent control and prevent infection in the fa-
before releasing information not re- cility and to investigate and identify
quired to be released by law. possible causes of infection.
(c) Standard: Retention and preserva- (2) The facility must monitor the in-
tion. The facility must retain clinical fection control program to ensure that
record information for 5 years after pa- the staff implement the policies and
tient discharge and must make provi- procedures and that the policies and
sion for the maintenance of such procedures are consistent with current
records in the event that it is no longer practices in the field.
able to treat patients. (3) The facility must make available
at all times a quantity of laundered
§ 485.62 Condition of participation: linen adequate for proper care and
Physical environment. comfort of patients. Linens must be
The facility must provide a physical handled, stored, and processed in a
environment that protects the health manner that prevents the spread of in-
and safety or patients, personnel, and fection.
the public. (4) Provisions must be in effect to en-
(a) Standard: Safety and comfort of pa- sure that the facility’s premises are
tients. The physical premises of the fa- maintained free of rodent and insect
cility and those areas of its sur- infestation.
rounding physical structure that are (c) Standard: Maintenance of equip-

used by the patients (including at least ment, physical location, and grounds.
all stairwells, corridors and passage- The facility must establish a written
197
§ 485.64 42 CFR Ch. IV (10–1–17 Edition)
preventive maintenance program to en- sociated with the facility, must carry
sure that— out the utilization review plan.
(1) All equipment is properly main- (b) Standard: Utilization review plan.
tained and equipment needing periodic The utilization review plan must con-
calibration is calibrated consistent tain written procedures for evalu-
with the manufacturer’s recommenda- ating—
tions; and (1) Admissions, continued care, and
(2) The interior of the facility, the discharges using, at a minimum, the
exterior of the physical structure hous- criteria established in the patient care
ing the facility, and the exterior walk- policies;
ways and parking areas are clean and (2) The applicability of the plan of
orderly and maintained free of any de- treatment to established goals; and
fects that are a hazard to patients, per-
(3) The adequacy of clinical records
sonnel, and the public.
with regard to—
(d) Standard: Access for the physically
impaired. The facility must ensure the (i) Assessing the quality of services
following: provided; and
(1) Doorways, stairwells, corridors, (ii) Determining whether the facili-
and passageways used by patients are— ty’s policies and clinical practices are
(i) Of adequate width to allow for compatible and promote appropriate
easy movement of all patients (includ- and efficient utilization of services.
ing those on stretchers or in wheel-
chairs); and § 485.68 Condition of participation:
Emergency preparedness.
(ii) In the case of stairwells, equipped
with firmly attached handrails on at The Comprehensive Outpatient Reha-
least one side. bilitation Facility (CORF) must com-
(2) At least one toilet facility is ac- ply with all applicable Federal, State,
cessible and constructed to allow utili- and local emergency preparedness re-
zation by ambulatory and non- quirements. The CORF must establish
ambulatory individuals. and maintain an emergency prepared-
(3) At least one entrance is usable by ness program that meets the require-
individuals in wheelchairs. ments of this section. The emergency
(4) In multi-story buildings, elevators preparedness program must include,
are accessible to and usable by the but not be limited to, the following ele-
physically impaired on the level that ments:
they use to enter the building and all (a) Emergency plan. The CORF must
levels normally used by the patients of develop and maintain an emergency
the facility. preparedness plan that must be re-
(5) Parking spaces are large enough viewed and updated at least annually.
and close enough to the facility to The plan must do all of the following:
allow safe access by the physically im- (1) Be based on and include a docu-
paired. mented, facility-based and community-
§ 485.64 [Reserved] based risk assessment, utilizing an all-
hazards approach.
§ 485.66 Condition of participation: (2) Include strategies for addressing
Utilization review plan. emergency events identified by the
The facility must have in effect a risk assessment.
written utilization review plan that is (3) Address patient population, in-
implemented at least each quarter, to cluding, but not limited to, the type of
assess the necessity of services and services the CORF has the ability to
promotes the most efficient use of provide in an emergency; and con-
services provided by the facility. tinuity of operations, including delega-
(a) Standard: Utilization review com- tions of authority and succession
mittee. The utilization review com- plans.
mittee, consisting of the group of pro- (4) Include a process for cooperation
fessional personnel specified in and collaboration with local, tribal, re-
§ 485.56(c), a committee of this group, or gional, State, and Federal emergency

a group of similar composition, com- preparedness officials’ efforts to main-
prised by professional personnel not as- tain an integrated response during a
198
disaster or emergency situation, in- (i) Federal, State, tribal, regional

cluding documentation of the CORF’s and local emergency preparedness
efforts to contact such officials and, staff.
when applicable, of its participation in (ii) Other sources of assistance.
collaborative and cooperative planning (3) Primary and alternate means for
efforts; communicating with the CORF’s staff,
(5) Be developed and maintained with Federal, State, tribal, regional, and
assistance from fire, safety, and other local emergency management agencies.
appropriate experts. (4) A method for sharing information
(b) Policies and procedures. The CORF and medical documentation for pa-
must develop and implement emer- tients under the CORF’s care, as nec-
gency preparedness policies and proce- essary, with other health care pro-
dures, based on the emergency plan set viders to maintain the continuity of
forth in paragraph (a) of this section, care.
risk assessment at paragraph (a)(1) of (5) A means of providing information
this section, and the communication about the CORF’s needs, and its ability
plan at paragraph (c) of this section. to provide assistance, to the authority
The policies and procedures must be re- having jurisdiction or the Incident
viewed and updated at least annually. Command Center, or designee.
At a minimum, the policies and proce- (d) Training and testing. The CORF
dures must address the following: must develop and maintain an emer-
(1) Safe evacuation from the CORF, gency preparedness training and test-
which includes staff responsibilities, ing program that is based on the emer-
and needs of the patients. gency plan set forth in paragraph (a) of
(2) A means to shelter in place for pa- this section, risk assessment at para-
tients, staff, and volunteers who re- graph (a)(1) of this section, policies and
main in the facility. procedures at paragraph (b) of this sec-
tion, and the communication plan at
(3) A system of medical documenta-
paragraph (c) of this section. The train-
tion that preserves patient informa-
ing and testing program must be re-
tion, protects confidentiality of patient
information, and secures and main-
(1) Training program. The CORF must
tains the availability of records.
(4) The use of volunteers in an emer-
(i) Provide initial training in emer-
gency and other emergency staffing
gency preparedness policies and proce-
strategies, including the process and
dures to all new and existing staff, in-
role for integration of State or Feder-
dividuals providing services under ar-
ally designated health care profes-
rangement, and volunteers, consistent
sionals to address surge needs during
with their expected roles.
an emergency.
(ii) Provide emergency preparedness
(c) Communication plan. The CORF training at least annually.
must develop and maintain an emer-
(iii) Maintain documentation of the
gency preparedness communication
training.
plan that complies with Federal, State,
(iv) Demonstrate staff knowledge of
and local laws and must be reviewed
emergency procedures. All new per-
and updated at least annually. The
sonnel must be oriented and assigned
communication plan must include all
specific responsibilities regarding the
of the following:
CORF’s emergency plan within 2 weeks
(1) Names and contact information of their first workday. The training
for the following: program must include instruction in
(i) Staff. the location and use of alarm systems
(ii) Entities providing services under and signals and firefighting equipment.
arrangement. (2) Testing. The CORF must conduct
(iii) Patients’ physicians. exercises to test the emergency plan at
(iv) Other CORFs. least annually. The CORF must do the
(v) Volunteers. following:

(2) Contact information for the fol- (i) Participate in a full-scale exercise
lowing: that is community-based or when a
199
§ 485.70 42 CFR Ch. IV (10–1–17 Edition)
community-based exercise is not acces- grated emergency plan must also be

sible, an individual, facility-based. If based on and include the following:
the CORF experiences an actual nat- (i) A documented community–based
ural or man-made emergency that re- risk assessment, utilizing an all-haz-
quires activation of the emergency ards approach.
plan, the CORF is exempt from engag- (ii) A documented individual facility-
ing in a community-based or indi- based risk assessment for each sepa-
vidual, facility-based full-scale exer- rately certified facility within the
cise for 1 year following the onset of health system, utilizing an all-hazards
the actual event. approach.
(ii) Conduct an additional exercise (5) Include integrated policies and
that may include, but is not limited to procedures that meet the requirements
the following: set forth in paragraph (b) of this sec-
(A) A second full-scale exercise that tion, a coordinated communication
is community-based or individual, fa- plan and training and testing programs
cility-based. that meet the requirements of para-
(B) A tabletop exercise that includes graphs (c) and (d) of this section, re-
a group discussion led by a facilitator, spectively.
using a narrated, clinically-relevant [81 FR 64035, Sept. 16, 2016]
lem statements, directed messages, or § 485.70 Personnel qualifications.
prepared questions designed to chal- This section sets forth the qualifica-
lenge an emergency plan. tions that must be met, as a condition
(iii) Analyze the CORF’s response to of participation, under § 485.58, and as a
and maintain documentation of all condition of coverage of services under
drills, tabletop exercises, and emer- § 410.100 of this chapter.
gency events, and revise the CORF’s (a) A facility physician must be a
emergency plan, as needed. doctor of medicine or osteopathy who—
(e) Integrated healthcare systems. If a (1) Is licensed under State law to
CORF is part of a healthcare system practice medicine or surgery; and
consisting of multiple separately cer- (2) Has had, subsequent to com-
tified healthcare facilities that elects pleting a 1-year hospital internship, at
to have a unified and integrated emer- least 1 year of training in the medical
gency preparedness program, the CORF management of patients requiring re-
may choose to participate in the habilitation services; or
healthcare system’s coordinated emer- (3) Has had at least 1 year of full-
gency preparedness program. If elected, time or part-time experience in a reha-
the unified and integrated emergency bilitation setting providing physicians’
preparedness program must do all of services similar to those required in
the following: this subpart.
(1) Demonstrate that each separately (b) A licensed practical nurse must be
certified facility within the system ac- licensed as a practical or vocational
tively participated in the development nurse by the State in which practicing,
of the unified and integrated emer- if applicable.
gency preparedness program. (c) An occupational therapist and an
(2) Be developed and maintained in a occupational therapy assistant must
manner that takes into account each meet the qualifications in § 484.4 of this
separately certified facility’s unique chapter.
circumstances, patient populations, (d) An orthotist must—
and services offered. (1) Be licensed by the State in which
(3) Demonstrate that each separately practicing, if applicable;
certified facility is capable of actively (2) Have successfully completed a
using the unified and integrated emer- training program in orthotics that is
gency preparedness program and is in jointly recognized by the American
compliance with the program. Council on Education and the Amer-
(4) Include a unified and integrated ican Board for Certification in
emergency plan that meets the require- Orthotics and Prosthetics; and
ments of paragraphs (a)(2), (3), and (4) (3) Be eligible to take that Board’s
of this section. The unified and inte- certification examination in orthotics.
200
(e) A physical therapist and a phys- (ii) Have equivalent training and ex-
ical therapist assistant must meet the perience as determined by the National
qualifications in § 484.4 of this chapter. Board for Respiratory Care.
(f) A prosthetist must— (k) A respiratory therapy technician
(1) Be licensed by the State in which must—
practicing, if applicable; (1) Be licensed by the State in which
(2) Have successfully completed a practicing, if applicable;
training program in prosthetics that is (2) Have successfully completed a
jointly recognized by the American training program accredited by the
Council on Education and the Amer- Committees on Allied Health Edu-
ican Board for Certification in cation and Accreditation (CAHEA) in
Orthotics and Prosthetics; and collaboration with the Joint Review
(3) Be eligible to take that Board’s Committee for Respiratory Therapy
certification examination in pros- Education; and
thetics. (3) Either—
(g) A psychologist must be certified or (i) Be eligible to take the certifi-
licensed by the State in which he or cation examination for respiratory
she is practicing, if that State requires therapy technicians administered by
certification or licensing, and must the National Board for Respiratory
hold a masters degree in psychology Therapy, Inc,; or
from and educational institution ap- (ii) Have equivalent training and ex-
proved by the State in which the insti- perience as determined by the National
tution is located. Board for Respiratory Therapy, Inc.
(h) A registered nurse must be a grad- (l) A social worker must—
uate of an approved school of nursing (1) Be licensed by the State in which
and be licensed as a registered nurse by practicing, if applicable;
the State in which practicing, if appli-
(2) Hold at least a bachelor’s degree
cable.
from a school accredited or approved
(i) A rehabilitation counselor must—
by the Council on Social Work Edu-
(1) Be licensed by the State in which cation; and
practicing, if applicable;
(3) Have 1 year of social work experi-
(2) Hold at least a bachelor’s degree; ence in a health care setting.
and
(m) A speech-language pathologist
(3) Be eligible to take the certifi-
must meet the qualifications set forth
cation examination administered by
in part 484 of this chapter.
the Commission on Rehabilitation
Counselor Certification. [48 FR 56293, Dec. 15, 1982. Redesignated and
(j) A respiratory therapist must com- amended at 50 FR 33034, Aug. 16, 1985; 51 FR
plete one the following criteria: 41352, Nov. 14, 1986; 60 FR 2327, Jan. 9, 1995; 72
FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19,
(1) Criterion 1. All of the following
2008; 74 FR 62014, Nov. 25, 2009]
must be completed:
(i) Be licensed by the State in which EFFECTIVE DATE NOTE: At 82 FR 4591, Jan.
practicing, if applicable. 13, 2017, § 485.70(c) and (e) was amended by re-
moving ‘‘§ 484.4’’ and adding in its place
(ii) Have successfully completed a na- ‘‘§ 484.115’’, effective July 13, 2017. At 82 FR
tionally-accredited educational pro- 31729, July 10, 2017, this amendment was de-
gram for respiratory therapists. layed until Jan. 13, 2018.
(iii)(A) Be eligible to take the reg-
istry examination administered by the § 485.74 Appeal rights.
National Board for Respiratory Care The appeal provisions set forth in
for respiratory therapists; or part 498 of this chapter, for providers,
(B) Have passed the registry exam- are applicable to any entity that is
ination administered by the National participating or seeks to participate in
Board for Respiratory Care for res- the Medicare program as a CORF.
piratory therapists.
(2) Criterion 2: All of the following [48 FR 56293, Dec. 15, 1982, as amended at 52
must be completed: FR 22454, June 12, 1987]

(i) Be licensed by the State in which
practicing, if applicable. Subparts C–E [Reserved]
201
§ 485.601 42 CFR Ch. IV (10–1–17 Edition)
Subpart F—Conditions of Partici- (a) Clinical nurse specialist. A clinical

pation: Critical Access Hos- nurse specialist must be a person who—
(1) Is a registered nurse and is li-
pitals (CAHs) censed to practice nursing in the State
in which the clinical nurse specialist
SOURCE: 58 FR 30671, May 26, 1993, unless services are performed in accordance
otherwise noted.
with State nurse licensing laws and
§ 485.601 Basis and scope. regulations; and
(2) Holds a master’s or doctoral level
(a) Statutory basis. This subpart is degree in a defined clinical area of
based on section 1820 of the Act which nursing from an accredited educational
sets forth the conditions for desig- institution.
nating certain hospitals as CAHs. (b) Nurse practitioner. A nurse practi-
(b) Scope. This subpart sets forth the tioner must be a registered profes-
conditions that a hospital must meet sional nurse who is currently licensed
to be designated as a CAH. to practice in the State, who meets the
[58 FR 30671, May 26, 1993, as amended at 62 State’s requirements governing the
FR 46037, Aug. 29, 1997] qualification of nurse practitioners,
and who meets one of the following
§ 485.603 Rural health network. conditions:
A rural health network is an organi- (1) Is currently certified as a primary
zation that meets the following speci- care nurse practitioner by the Amer-
fications: ican Nurses’ Association or by the Na-
(a) It includes— tional Board of Pediatric Nurse Practi-
(1) At least one hospital that the tioners and Associates.
State has designated or plans to des- (2) Has successfully completed a 1
ignate as a CAH; and academic year program that—
(2) At least one hospital that fur- (i) Prepares registered nurses to per-
nishes acute care services. form an expanded role in the delivery
of primary care;
(b) The members of the organization
(ii) Includes at least 4 months (in the
have entered into agreements regard-
aggregate) of classroom instruction
ing—
and a component of supervised clinical
(1) Patient referral and transfer;
practice; and
(2) The development and use of com-
(iii) Awards a degree, diploma, or cer-
munications systems, including, where
tificate to persons who successfully
feasible, telemetry systems and sys-
complete the program.
tems for electronic sharing of patient
(3) Has successfully completed a for-
data; and
mal educational program (for pre-
(3) The provision of emergency and
paring registered nurses to perform an
nonemergency transportation among
expanded role in the delivery of pri-
members.
mary care) that does not meet the re-
(c) Each CAH has an agreement with
quirements of paragraph (a)(2) of this
respect to credentialing and quality as-
section, and has been performing an ex-
surance with at least—
panded role in the delivery of primary
(1) One hospital that is a member of care for a total of 12 months during the
the network when applicable; 18-month period immediately preceding
(2) One QIO or equivalent entity; or June 25, 1993.
(3) One other appropriate and quali- (c) Physician assistant. A physician
fied entity identified in the State rural assistant must be a person who meets
health care plan. the applicable State requirements gov-
[58 FR 30671, May 26, 1993, as amended at 62 erning the qualifications for assistants
FR 46035, Aug. 29, 1997; 63 FR 26359, May 12, to primary care physicians, and who
1998] meets at least one of the following con-
ditions:
§ 485.604 Personnel qualifications. (1) Is currently certified by the Na-
Staff that furnish services in a CAH tional Commission on Certification of

must meet the applicable requirements Physician Assistants to assist primary
of this section. care physicians.
202
(2) Has satisfactorily completed a otherwise eligible to be designated as a

program for preparing physician assist- CAH by the State under the rules in
ants that— this subpart.
(i) Was at least one academic year in
length;
FR 26359, May 12, 1998; 79 FR 27155, May 12,
(ii) Consisted of supervised clinical 2014]
practice and at least 4 months (in the
aggregate) of classroom instruction di- § 485.608 Condition of participation:
rected toward preparing students to de- Compliance with Federal, State,
liver health care; and and local laws and regulations.
(iii) Was accredited by the American
The CAH and its staff are in compli-
Medical Association’s Committee on
ance with applicable Federal, State
Allied Health Education and Accredita-
and local laws and regulations.
tion.
(3) Has satisfactorily completed a (a) Standard: Compliance with Federal
formal educational program (for pre- laws and regulations. The CAH is in
paring physician assistants) that does compliance with applicable Federal
not meet the requirements of para- laws and regulations related to the
graph (c)(2) of this section and has been health and safety of patients.
assisting primary care physicians for a (b) Standard: Compliance with State
total of 12 months during the 18-month and local laws and regulations. All pa-
period immediately preceding June 25, tient care services are furnished in ac-
1993. cordance with applicable State and
local laws and regulations.
[58 FR 30671, May 26, 1993, as amended at 62 (c) Standard: Licensure of CAH. The
FR 46037, Aug. 29, 1997; 77 FR 29076, May 16,
2012]
CAH is licensed in accordance with ap-
plicable Federal, State and local laws
§ 485.606 Designation and certification and regulations.
of CAHs. (d) Standard: Licensure, certification or
(a) Criteria for State designation. (1) A registration of personnel. Staff of the
State that has established a Medicare CAH are licensed, certified, or reg-
rural hospital flexibility program de- istered in accordance with applicable
scribed in section 1820(c) of the Act Federal, State, and local laws and reg-
may designate one or more facilities as ulations.
CAHs if each facility meets the CAH [58 FR 30671, May 26, 1993, as amended at 62
conditions of participation in this sub- FR 46037, Aug. 29, 1997]
part F.
(2) The State must not deny any hos- § 485.610 Condition of participation:
pital that is otherwise eligible for des- Status and location.
ignation as a CAH under this para- (a) Standard: Status. The facility is—
graph (a) solely because the hospital (1) A currently participating hospital
has entered into an agreement under that meets all conditions of participa-
which the hospital may provide tion set forth in this subpart;
posthospital SNF care as described in
(2) A recently closed facility, pro-
§ 482.58 of this chapter.
vided that the facility—
(b) Criteria for CMS certification.
CMS certifies a facility as a CAH if— (i) Was a hospital that ceased oper-
(1) The facility is designated as a ations on or after the date that is 10
CAH by the State in which it is located years before November 29, 1999; and
and has been surveyed by the State (ii) Meets the criteria for designation
survey agency or by CMS and found to under this subpart as of the effective
meet all conditions of participation in date of its designation; or
this part and all other applicable re- (3) A health clinic or a health center
quirements for participation in part 489 (as defined by the State) that—
of this chapter. (i) Is licensed by the State as a
(2) The facility is a medical assist- health clinic or a health center;
ance facility operating in Montana or a (ii) Was a hospital that was

rural primary care hospital designated downsized to a health clinic or a health
by CMS before August 5, 1997, and is center; and
203
§ 485.610 42 CFR Ch. IV (10–1–17 Edition)
(iii) As of the effective date of its tical Area as a result of the most re-
designation, meets the criteria for des- cent census data and implementation
ignation set forth in this subpart. of the new Metropolitan Statistical
(b) Standard: Location in a rural area Area definitions announced by the Of-
or treatment as rural. The CAH meets fice of Management and Budget on No-
the requirements of either paragraph vember 20, 2008.
(b)(1) or (b)(2) of this section or the re- (5) Effective on or after October 1,
quirements of paragraph (b)(3), (b)(4), 2014, for a period of 2 years beginning
or (b)(5) of this section. with the effective date of the most re-
(1) The CAH meets the following recent Office of Management and Budget
quirements: (OMB) standards for delineating statis-
(i) The CAH is located outside any tical areas adopted by CMS, the CAH
area that is a Metropolitan Statistical
no longer meets the location require-
Area, as defined by the Office of Man-
ments in either paragraph (b)(1) or
agement and Budget, or that has been
(b)(2) of this section and is located in a
recognized as urban under § 412.64(b),
county that, prior to the most recent
excluding paragraph (b)(3) of this chap-
ter; OMB standards for delineating statis-
(ii) The CAH has not been classified tical areas adopted by CMS and the
as an urban hospital for purposes of the most recent Census Bureau data, was
standardized payment amount by CMS located in a rural area as defined by
or the Medicare Geographic Classifica- OMB, but under the most recent OMB
tion Review Board under § 412.230(e) of standards for delineating statistical
this chapter, and is not among a group areas adopted by CMS and the most re-
of hospitals that have been redesig- cent Census Bureau data, is located in
nated to an adjacent urban area under an urban area.
§ 412.232 of this chapter. (c) Standard: Location relative to other
(2) The CAH is located within a Met- facilities or necessary provider certifi-
ropolitan Statistical Area, as defined cation. The CAH is located more than a
by the Office of Management and Budg- 35-mile drive (or, in the case of moun-
et, but is being treated as being located tainous terrain or in areas with only
in a rural area in accordance with secondary roads available, a 15-mile
§ 412.103 of this chapter. drive) from a hospital or another CAH,
(3) Effective for October 1, 2004 or before January 1, 2006, the CAH is
through September 30, 2006, the CAH certified by the State as being a nec-
does not meet the location require- essary provider of health care services
ments in either paragraph (b)(1) or to residents in the area. A CAH that is
(b)(2) of this section and is located in a designated as a necessary provider on
county that, in FY 2004, was not part of or before December 31, 2005, will main-
a Metropolitan Statistical Area as de- tain its necessary provider designation
fined by the Office of Management and after January 1, 2006.
Budget, but as of FY 2005 was included
(d) Standard: Relocation of CAHs with
as part of such a Metropolitan Statis-
a necessary provider designation. A CAH
tical Area as a result of the most re-
cent census data and implementation that has a necessary provider designa-
of the new Metropolitan Statistical tion from the State that was in effect
Area definitions announced by the Of- prior to January 1, 2006, and relocates
fice of Management and Budget on its facility after January 1, 2006, can
June 3, 2003. continue to meet the location require-
(4) Effective for October 1, 2009 ment of paragraph (c) of this section
through September 30, 2011, the CAH based on the necessary provider des-
does not meet the location require- ignation only if the relocated facility
ments in either paragraph (b)(1) or meets the requirements as specified in
(b)(2) of this section and is located in a paragraph (d)(1) of this section.
county that, in FY 2009, was not part of (1) If a necessary provider CAH relo-
a Metropolitan Statistical Area as de- cates its facility and begins providing
fined by the Office of Management and services in a new location, the CAH can
Budget, but, as of FY 2010, was included continue to meet the location require-
as part of such a Metropolitan Statis- ment of paragraph (c) of this section
204
based on the necessary provider des- more than a 35-mile drive (or, in the
ignation only if the CAH in its new lo- case of mountainous terrain or in areas
cation— with only secondary roads available, a
(i) Serves at least 75 percent of the 15-mile drive) from a hospital or an-
same service area that it served prior other CAH.
to its relocation; (3) If either a CAH or a CAH that has
(ii) Provides at least 75 percent of the been designated as a necessary provider
same services that it provided prior to by the State does not meet the require-
the relocation; and ments in paragraph (e)(1) of this sec-
(iii) Is staffed by 75 percent of the tion, by co-locating with another hos-
same staff (including medical staff, pital or CAH on or after January 1,
contracted staff, and employees) that 2008, or creates or acquires an off-cam-
were on staff at the original location. pus provider-based location or off-cam-
(2) If a CAH that has been designated pus distinct part unit on or after Janu-
as a necessary provider by the State ary 1, 2008, that does not meet the re-
begins providing services at another lo- quirements in paragraph (e)(2) of this
cation after January 1, 2006, and does section, the CAH’s provider agreement
not meet the requirements in para- will be subject to termination in ac-
graph (d)(1) of this section, the action cordance with the provisions of
will be considered a cessation of busi- § 489.53(a)(3) of this subchapter, unless
ness as described in § 489.52(b)(3). the CAH terminates the off-campus ar-
(e) Standard: Off-campus and co-loca- rangement or the co-location arrange-
tion requirements for CAHs. A CAH may ment, or both.
continue to meet the location require- [62 FR 46036, Aug. 29, 1997, as amended at 65
ments of paragraph (c) of this section FR 47052, Aug. 1, 2000; 66 FR 39938, Aug. 1,
only if the CAH meets the following: 2001; 69 FR 49271, Aug. 11, 2004; 69 FR 60252,
(1) If a CAH with a necessary pro- Oct. 7, 2004; 70 FR 47490, Aug. 12, 2005; 71 FR
vider designation is co-located (that is, 48143, Aug. 18, 2006; 72 FR 66934, Nov. 27, 2007;
it shares a campus, as defined in 73 FR 9862, Feb. 22, 2008; 74 FR 44001, Aug. 27,
§ 413.65(a)(2) of this chapter, with an- 2009; 75 FR 50418, Aug. 16, 2010; 79 FR 50359,
other hospital or CAH), the necessary Aug. 22, 2014]
provider CAH can continue to meet the § 485.612 Condition of participation:
location requirement of paragraph (c) Compliance with hospital require-
of this section only if the co-location ments at the time of application.
arrangement was in effect before Janu-
Except for recently closed facilities
ary 1, 2008, and the type and scope of
as described in § 485.610(a)(2), or health
services offered by the facility co-lo-
clinics or health centers as described in
cated with the necessary provider CAH
§ 485.610(a)(3), the facility is a hospital
do not change. A change of ownership
that has a provider agreement to par-
of any of the facilities with a co-loca-
ticipate in the Medicare program as a
tion arrangement that was in effect be-
hospital at the time the hospital ap-
fore January 1, 2008, will not be consid-
plies for designation as a CAH.
ered to be a new co-location arrange-
ment. [66 FR 32196, June 13, 2001]
(2) If a CAH or a necessary provider
CAH operates an off-campus provider- § 485.616 Condition of participation:
based location, excluding an RHC as Agreements.
defined in § 405.2401(b) of this chapter, (a) Standard: Agreements with network
but including a department or remote hospitals. In the case of a CAH that is a
location, as defined in § 413.65(a)(2) of member of a rural health network as
this chapter, or an off-campus distinct defined in § 485.603 of this chapter, the
part psychiatric or rehabilitation unit, CAH has in effect an agreement with at
as defined in § 485.647, that was created least one hospital that is a member of
or acquired by the CAH on or after the network for—
January 1, 2008, the CAH can continue (1) Patient referral and transfer;
to meet the location requirement of (2) The development and use of com-
paragraph (c) of this section only if the munications systems of the network,
off-campus provider-based location or including the network’s system for the
off-campus distinct part unit is located electronic sharing of patient data, and
205
§ 485.616 42 CFR Ch. IV (10–1–17 Edition)
telemetry and medical records, if the (2) When telemedicine services are
network has in operation such a sys- furnished to the CAH’s patients
tem; and through an agreement with a distant-
(3) The provision of emergency and site hospital, the CAH’s governing body
nonemergency transportation between or responsible individual may choose to
the facility and the hospital. rely upon the credentialing and privi-
(b) Standard: Agreements for leging decisions made by the governing
credentialing and quality assurance. body of the distant-site hospital re-
Each CAH that is a member of a rural garding individual distant-site physi-
health network shall have an agree- cians or practitioners. The CAH’s gov-
ment with respect to credentialing and erning body or responsible individual
quality assurance with at least— must ensure, through its written agree-
(1) One hospital that is a member of ment with the distant-site hospital,
the network; that the following provisions are met:
(2) One QIO or equivalent entity; or (i) The distant-site hospital providing
(3) One other appropriate and quali- telemedicine services is a Medicare-
fied entity identified in the State rural participating hospital.
health care plan.
(ii) The individual distant-site physi-
(c) Standard: Agreements for cian or practitioner is privileged at the
credentialing and privileging of telemedi-
distant-site hospital providing the tele-
cine physicians and practitioners. (1) The
medicine services, which provides a
governing body of the CAH must en-
sure that, when telemedicine services current list of the distant-site physi-
are furnished to the CAH’s patients cian’s or practitioner’s privileges at
through an agreement with a distant- the distant-site hospital;
site hospital, the agreement is written (iii) The individual distant-site phy-
and specifies that it is the responsi- sician or practitioner holds a license
bility of the governing body of the dis- issued or recognized by the State in
tant-site hospital to meet the following which the CAH is located; and
requirements with regard to its physi- (iv) With respect to a distant-site
cians or practitioners providing tele- physician or practitioner, who holds
medicine services: current privileges at the CAH whose
(i) Determine, in accordance with patients are receiving the telemedicine
State law, which categories of practi- services, the CAH has evidence of an
tioners are eligible candidates for ap- internal review of the distant-site phy-
pointment to the medical staff. sician’s or practitioner’s performance
(ii) Appoint members of the medical of these privileges and sends the dis-
staff after considering the rec- tant-site hospital such information for
ommendations of the existing members use in the periodic appraisal of the in-
of the medical staff. dividual distant-site physician or prac-
(iii) Assure that the medical staff has titioner. At a minimum, this informa-
bylaws. tion must include all adverse events
(iv) Approve medical staff bylaws and that result from the telemedicine serv-
other medical staff rules and regula- ices provided by the distant-site physi-
tions. cian or practitioner to the CAH’s pa-
(v) Ensure that the medical staff is tients and all complaints the CAH has
accountable to the governing body for received about the distant-site physi-
the quality of care provided to pa- cian or practitioner.
tients.
(3) The governing body of the CAH
(vi) Ensure the criteria for selection must ensure that when telemedicine
are individual character, competence,
services are furnished to the CAH’s pa-
training, experience, and judgment.
tients through an agreement with a
(vii) Ensure that under no cir-
distant-site telemedicine entity, the
cumstances is the accordance of staff
agreement is written and specifies that
membership or professional privileges
in the hospital dependent solely upon the distant-site telemedicine entity is

certification, fellowship or membership a contractor of services to the CAH and
in a specialty body or society. as such, in accordance with
206
§ 485.635(c)(4)(ii), furnishes the con- ices provided by the distant-site physi-

tracted services in a manner that en- cian or practitioner to the CAH’s pa-
ables the CAH to comply with all appli- tients and all complaints the CAH has
cable conditions of participation for received about the distant-site physi-
the contracted services, including, but cian or practitioner.
not limited to, the requirements in this [62 FR 46036, Aug. 29, 1997, as amended at 76
section with regard to its physicians FR 25564, May 5, 2011]
and practitioners providing telemedi-
cine services. § 485.618 Condition of participation:
(4) When telemedicine services are Emergency services.
furnished to the CAH’s patients The CAH provides emergency care
through an agreement with a distant- necessary to meet the needs of its inpa-
site telemedicine entity, the CAH’s tients and outpatients.
governing body or responsible indi- (a) Standard: Availability. Emergency
vidual may choose to rely upon the services are available on a 24-hours a
credentialing and privileging decisions day basis.
made by the governing body of the dis- (b) Standard: Equipment, supplies, and
tant-site telemedicine entity regarding medication. Equipment, supplies, and
individual distant-site physicians or medication used in treating emergency
practitioners. The CAH’s governing cases are kept at the CAH and are read-
body or responsible individual must en- ily available for treating emergency
sure, through its written agreement cases. The items available must in-
with the distant-site telemedicine enti- clude the following:
ty, that the following provisions are (1) Drugs and biologicals commonly
met: used in life-saving procedures, includ-
(i) The distant-site telemedicine enti- ing analgesics, local anesthetics, anti-
ty’s medical staff credentialing and biotics, anticonvulsants, antidotes and
privileging process and standards at emetics, serums and toxoids,
least meet the standards at paragraphs antiarrythmics, cardiac glycosides,
(c)(1)(i) through (c)(1)(vii) of this sec- antihypertensives, diuretics, and elec-
tion. trolytes and replacement solutions.
(ii) The individual distant-site physi- (2) Equipment and supplies commonly
cian or practitioner is privileged at the used in life-saving procedures, includ-
distant-site telemedicine entity pro- ing airways, endotracheal tubes, ambu
viding the telemedicine services, which bag/valve/mask, oxygen, tourniquets,
provides a current list to the CAH of immobilization devices, nasogastric
the distant-site physician’s or practi- tubes, splints, IV therapy supplies, suc-
tioner’s privileges at the distant-site tion machine, defibrillator, cardiac
telemedicine entity. monitor, chest tubes, and indwelling
(iii) The individual distant-site phy- urinary catheters.
sician or practitioner holds a license (c) Standard: Blood and blood products.
issued or recognized by the State in The facility provides, either directly or
which the CAH whose patients are re- under arrangements, the following:
ceiving the telemedicine services is lo- (1) Services for the procurement,
cated. safekeeping, and transfusion of blood,
(iv) With respect to a distant-site including the availability of blood
physician or practitioner, who holds products needed for emergencies on a
current privileges at the CAH whose 24-hours a day basis.
patients are receiving the telemedicine (2) Blood storage facilities that meet
services, the CAH has evidence of an the requirements of 42 CFR part 493,
internal review of the distant-site phy- subpart K, and are under the control
sician’s or practitioner’s performance and supervision of a pathologist or
of these privileges and sends the dis- other qualified doctor of medicine or
tant-site telemedicine entity such in- osteopathy. If blood banking services
formation for use in the periodic ap- are provided under an arrangement,
praisal of the distant-site physician or the arrangement is approved by the fa-
practitioner. At a minimum, this infor- cility’s medical staff and by the per-
mation must include all adverse events sons directly responsible for the oper-
that result from the telemedicine servation of the facility.
207
§ 485.618 42 CFR Ch. IV (10–1–17 Edition)
(d) Standard: Personnel. (1) Except as (i) The CAH has no greater than 10
specified in paragraph (d)(3) of this sec- beds;
tion, there must be a doctor of medi- (ii) The CAH is located in an area
cine or osteopathy, a physician assist- designated as a frontier area or remote
ant, a nurse practitioner, or a clinical location as described in paragraph
nurse specialist, with training or expe- (d)(1)(ii)(A) of this section;
rience in emergency care, on call and (iii) The State in which the CAH is
immediately available by telephone or located submits a letter to CMS signed
radio contact, and available on site by the Governor, following consulta-
within the following timeframes:
tion on the issue of using RNs on a
(i) Within 30 minutes, on a 24-hour a
temporary basis as part of their State
day basis, if the CAH is located in an
area other than an area described in rural healthcare plan with the State
paragraph (d)(1)(ii) of this section; or Boards of Medicine and Nursing, and in
(ii) Within 60 minutes, on a 24-hour a accordance with State law, requesting
day basis, if all of the following re- that a registered nurse with training
quirements are met: and experience in emergency care be
(A) The CAH is located in an area included in the list of personnel speci-
designated as a frontier area (that is, fied in paragraph (d)(1) of this section.
an area with fewer than six residents The letter from the Governor must at-
per square mile based on the latest test that he or she has consulted with
population data published by the Bu- State Boards of Medicine and Nursing
reau of the Census) or in an area that about issues related to access to and
meets the criteria for a remote loca- the quality of emergency services in
tion adopted by the State in its rural the States. The letter from the Gov-
health care plan, and approved by CMS, ernor must also describe the cir-
under section 1820(b) of the Act. cumstances and duration of the tem-
(B) The State has determined, under porary request to include the reg-
criteria in its rural health care plan, istered nurses on the list of personnel
that allowing an emergency response specified in paragraph (d)(1) of this sec-
time longer than 30 minutes is the only tion;
feasible method of providing emer-
(iv) Once a Governor submits a let-
gency care to residents of the area
ter, as specified in paragraph (d)(3)(iii)
served by the CAH.
(C) The State maintains documenta- of this section, a CAH must submit
tion showing that the response time of documentation to the State survey
up to 60 minutes at a particular CAH it agency demonstrating that it has been
designates is justified because other unable, due to the shortage of such per-
available alternatives would increase sonnel in the area, to provide adequate
the time needed to stabilize a patient coverage as specified in this paragraph
in an emergency. (d).
(2) A registered nurse with training (4) The request, as specified in para-
and experience in emergency care can graph (d)(3)(iii) of this section, and the
be utilized to conduct specific medical withdrawal of the request, may be sub-
screening examinations only if— mitted to us at any time, and are effec-
(i) The registered nurse is on site and tive upon submission.
immediately available at the CAH (e) Standard: Coordination with emer-
when a patient requests medical care; gency response systems. The CAH must,
and in coordination with emergency re-
(ii) The nature of the patient’s response systems in the area, establish
quest for medical care is within the procedures under which a doctor of
scope of practice of a registered nurse medicine or osteopathy is immediately
and consistent with applicable State available by telephone or radio contact
laws and the CAH’s bylaws or rules and
on a 24-hours a day basis to receive
regulations.
emergency calls, provide information
(3) A registered nurse satisfies the
personnel requirement specified in on treatment of emergency patients,

paragraph (d)(1) of this section for a
temporary period if—
208
and refer patients to the CAH or other mable or combustible materials must
appropriate locations for treatment. be provided with positive latching
[58 FR 30671, May 26, 1993, as amended at 62
hardware. Roller latches are prohibited
FR 46037, Aug. 29, 1997; 64 FR 41544, July 30, on such doors.
1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, (2) In consideration of a rec-
Aug. 11, 2004; 71 FR 68230, Nov. 24, 2006] ommendation by the State survey
agency or Accrediting Organization or
§ 485.620 Condition of participation: at the discretion of the Secretary, may
Number of beds and length of stay. waive, for periods deemed appropriate,
(a) Standard: Number of beds. Except specific provisions of the Life Safety
as permitted for CAHs having distinct Code, which would result in unreason-
part units under § 485.647, the CAH able hardship upon a CAH, but only if
maintains no more than 25 inpatient the waiver will not adversely affect the
beds. Inpatient beds may be used for ei- health and safety of the patients.
ther inpatient or swing-bed services. (3) After consideration of State sur-
(b) Standard: Length of stay. The CAH vey agency findings, CMS may waive
provides acute inpatient care for a pe- specific provisions of the Life Safety
riod that does not exceed, on an annual Code that, if rigidly applied, would re-
average basis, 96 hours per patient. sult in unreasonable hardship on the
CAH, but only if the waiver does not
FR 47052, Aug. 1, 2000; 69 FR 49271, Aug. 11, adversely affect the health and safety
2004; 69 FR 60252, Oct. 7, 2004; 78 FR 50970, of patients.
Aug. 19, 2013] (4) The CAH maintains written evi-
dence of regular inspection and ap-
§ 485.623 Condition of participation: proval by State or local fire control
Physical plant and environment. agencies.
(a) Standard: Construction. The CAH is (5) A CAH may install alcohol-based
constructed, arranged, and maintained hand rub dispensers in its facility if the
to ensure access to and safety of pa- dispensers are installed in a manner
tients, and provides adequate space for that adequately protects against inap-
the provision of services. propriate access.
(b) Standard: Maintenance. The CAH (6) When a sprinkler system is shut
has housekeeping and preventive main- down for more than 10 hours, the CAH
tenance programs to ensure that— must:
(1) All essential mechanical, elec- (i) Evacuate the building or portion
trical, and patient-care equipment is of the building affected by the system
maintained in safe operating condition; outage until the system is back in
(2) There is proper routine storage service, or
and prompt disposal of trash; (ii) Establish a fire watch until the
(3) Drugs and biologicals are appro- system is back in service.
priately stored; (7) Buildings must have an outside
(4) The premises are clean and or- window or outside door in every sleep-
derly; and ing room, and for any building con-
(5) There is proper ventilation, light- structed after July 5, 2016 the sill
ing, and temperature control in all height must not exceed 36 inches above
pharmaceutical, patient care, and food the floor. Windows in atrium walls are
preparation areas. considered outside windows for the pur-
(c) Standard: Life safety from fire. (1) poses of this requirement.
Except as otherwise provided in this (i) The sill height requirement does
section— not apply to newborn nurseries and
(i) The CAH must meet the applicable rooms intended for occupancy for less
provisions and must proceed in accord- than 24 hours.
ance with the Life Safety Code (NFPA (ii) Special nursing care areas of new
101 and Tentative Interim Amendments occupancies shall not exceed 60 inches.
TIA 12–1, TIA 12–2, TIA 12–3, and TIA (d) Standard: Building safety. Except
12–4.) as otherwise provided in this section,
(ii) Notwithstanding paragraph the CAH must meet the applicable pro-
(d)(1)(i) of this section, corridor doors visions and must proceed in accordance
and doors to rooms containing flam- with the Health Care Facilities Code
209
§ 485.625 42 CFR Ch. IV (10–1–17 Edition)
(NFPA 99 and Tentative Interim (xi) TIA 12–4 to NFPA 101, issued Oc-
Amendments TIA 12–2, TIA 12–3, TIA tober 22, 2013.
12–4, TIA 12–5 and TIA 12–6). (2) [Reserved]
(1) Chapters 7, 8, 12, and 13 of the
adopted Health Care Facilities Code do FR 46036, 46037, Aug. 29, 1997; 68 FR 1387, Jan.
not apply to a CAH. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR 15239,
(2) If application of the Health Care Mar. 25, 2005; 71 FR 55341, Sept. 22, 2006; 77 FR
Facilities Code required under para- 29076, May 16, 2012; 81 FR 26901, May 4, 2016;
graph (e) of this section would result in 81 FR 64036, Sept. 16, 2016]
unreasonable hardship for the CAH,
CMS may waive specific provisions of § 485.625 Condition of participation:
the Health Care Facilities Code, but Emergency preparedness.
only if the waiver does not adversely The CAH must comply with all appli-
affect the health and safety of patients. cable Federal, State, and local emer-
(e) The standards incorporated by gency preparedness requirements. The
reference in this section are approved CAH must develop and maintain a com-
for incorporation by reference by the prehensive emergency preparedness
Director of the Office of the Federal program, utilizing an all-hazards ap-
Register in accordance with 5 U.S.C. proach. The emergency preparedness
552(a) and 1 CFR part 51. You may in- plan must include, but not be limited
spect a copy at the CMS Information to, the following elements:
Resource Center, 7500 Security Boule- (a) Emergency plan. The CAH must de-
vard, Baltimore, MD or at the National velop and maintain an emergency pre-
Archives and Records Administration paredness plan that must be reviewed
(NARA). For information on the avail- and updated at least annually. The
ability of this material at NARA, call plan must do all of the following:
202–741–6030, or go to: http:// (1) Be based on and include a docu-
www.archives.gov/federallregister/ mented, facility-based and community-
codeloflfederallregulations/ based risk assessment, utilizing an all-
ibrllocations.html. If any changes in hazards approach.
this edition of the Code are incor- (2) Include strategies for addressing
porated by reference, CMS will publish emergency events identified by the
a document in the FEDERAL REGISTER risk assessment.
to announce the changes. (3) Address patient population, in-
(1) National Fire Protection Associa- cluding, but not limited to, persons at-
tion, 1 Batterymarch Park, Quincy, risk; the type of services the CAH has
MA 02169, www.nfpa.org, 1.617.770.3000. the ability to provide in an emergency;
(i) NFPA 99, Standards for Health and continuity of operations, including
Care Facilities Code of the National delegations of authority and succession
Fire Protection Association 99, 2012 plans.
edition, issued August 11, 2011. (4) Include a process for cooperation
(ii) TIA 12–2 to NFPA 99, issued Au- and collaboration with local, tribal, re-
gust 11, 2011. gional, State, and Federal emergency
(iii) TIA 12–3 to NFPA 99, issued Au- preparedness officials’ efforts to main-
gust 9, 2012. tain an integrated response during a
(iv) TIA 12–4 to NFPA 99, issued disaster or emergency situation, in-
March 7, 2013. cluding documentation of the CAH’s ef-
(v) TIA 12–5 to NFPA 99, issued Au- forts to contact such officials and,
gust 1, 2013. when applicable, of its participation in
(vi) TIA 12–6 to NFPA 99, issued collaborative and cooperative planning
March 3, 2014. efforts.
(vii) NFPA 101, Life Safety Code, 2012 (b) Policies and procedures. The CAH
edition, issued August 11, 2011; must develop and implement emer-
(viii) TIA 12–1 to NFPA 101, issued gency preparedness policies and proce-
August 11, 2011. dures, based on the emergency plan set
(ix) TIA 12–2 to NFPA 101, issued Oc- forth in paragraph (a) of this section,
tober 30, 2012. risk assessment at paragraph (a)(1) of

(x) TIA 12–3 to NFPA 101, issued Oc- this section, and the communication
tober 22, 2013. plan at paragraph (c) of this section.
210
The policies and procedures must be re- the provision of care and treatment at
viewed and updated at least annually. an alternate care site identified by
At a minimum, the policies and proce- emergency management officials.
dures must address the following: (c) Communication plan. The CAH
(1) The provision of subsistence needs must develop and maintain an emer-
for staff and patients, whether they gency preparedness communication
evacuate or shelter in place, include, plan that complies with Federal, State,
but are not limited to— and local laws and must be reviewed
(i) Food, water, medical, and pharma- and updated at least annually. The
ceutical supplies; communication plan must include all
(ii) Alternate sources of energy to of the following:
maintain: (1) Names and contact information
(A) Temperatures to protect patient for the following:
health and safety and for the safe and (i) Staff.
sanitary storage of provisions; (ii) Entities providing services under
(B) Emergency lighting; arrangement.
(C) Fire detection, extinguishing, and (iii) Patients’ physicians.
alarm systems; and (iv) Other CAHs and hospitals.
(D) Sewage and waste disposal. (v) Volunteers.
(2) A system to track the location of (2) Contact information for the fol-
on-duty staff and sheltered patients in lowing:
the CAH’s care during an emergency. If (i) Federal, State, tribal, regional,
on-duty staff and sheltered patients are and local emergency preparedness
relocated during the emergency, the staff.
CAH must document the specific name (ii) Other sources of assistance.
and location of the receiving facility or (3) Primary and alternate means for
other location. communicating with the following:
(3) Safe evacuation from the CAH, (i) CAH’s staff.
which includes consideration of care (ii) Federal, State, tribal, regional,
and treatment needs of evacuees; staff and local emergency management
responsibilities; transportation; identi- agencies.
fication of evacuation location(s); and (4) A method for sharing information
primary and alternate means of com- and medical documentation for pa-
munication with external sources of as- tients under the CAH’s care, as nec-
sistance. essary, with other health care pro-
(4) A means to shelter in place for pa- viders to maintain the continuity of
tients, staff, and volunteers who re- care.
main in the facility. (5) A means, in the event of an evacu-
(5) A system of medical documenta- ation, to release patient information as
tion that preserves patient informa- permitted under 45 CFR 164.510(b)(1)(ii).
tion, protects confidentiality of patient (6) A means of providing information
information, and secures and main- about the general condition and loca-
tains the availability of records. tion of patients under the facility’s
(6) The use of volunteers in an emer- care as permitted under 45 CFR
gency or other emergency staffing 164.510(b)(4).
strategies, including the process and (7) A means of providing information
role for integration of State or Feder- about the CAH’s occupancy, needs, and
ally designated health care profes- its ability to provide assistance, to the
sionals to address surge needs during authority having jurisdiction or the In-
an emergency. cident Command Center, or designee.
(7) The development of arrangements (d) Training and testing. The CAH
with other CAHs or other providers to must develop and maintain an emer-
receive patients in the event of limita- gency preparedness training and test-
tions or cessation of operations to ing program that is based on the emer-
maintain the continuity of services to gency plan set forth in paragraph (a) of
CAH patients. this section, risk assessment at para-
(8) The role of the CAH under a waiv- graph (a)(1) of this section, policies and
er declared by the Secretary, in accord- procedures at paragraph (b) of this sec-
ance with section 1135 of the Act, in tion, and the communication plan at
211
§ 485.625 42 CFR Ch. IV (10–1–17 Edition)
paragraph (c) of this section. The train- based on the emergency plan set forth
ing and testing program must be rein paragraph (a) of this section.
viewed and updated at least annually. (1) Emergency generator location. The
(1) Training program. The CAH must generator must be located in accord-
do all of the following: ance with the location requirements
(i) Initial training in emergency pre- found in the Health Care Facilities
paredness policies and procedures, in- Code (NFPA 99 and Tentative Interim
cluding prompt reporting and extin- Amendments TIA 12–2, TIA 12–3, TIA
guishing of fires, protection, and where 12–4, TIA 12–5, and TIA 12–6), Life Safe-
necessary, evacuation of patients, per- ty Code (NFPA 101 and Tentative In-
sonnel, and guests, fire prevention, and terim Amendments TIA 12–1, TIA 12–2,
cooperation with firefighting and dis- TIA 12–3, and TIA 12–4), and NFPA 110,
aster authorities, to all new and exist-
when a new structure is built or when
ing staff, individuals providing services
an existing structure or building is ren-
under arrangement, and volunteers,
ovated.
consistent with their expected roles.
(ii) Provide emergency preparedness (2) Emergency generator inspection and
training at least annually. testing. The CAH must implement
(iii) Maintain documentation of the emergency power system inspection
training. and testing requirements found in the
(iv) Demonstrate staff knowledge of Health Care Facilities Code, NFPA 110,
emergency procedures. and the Life Safety Code.
(2) Testing. The CAH must conduct (3) Emergency generator fuel. CAHs
exercises to test the emergency plan at that maintain an onsite fuel source to
least annually. The CAH must do the power emergency generators must have
following: a plan for how it will keep emergency
(i) Participate in a full-scale exercise power systems operational during the
that is community-based or when a emergency, unless it evacuates.
community-based exercise is not acces- (f) Integrated healthcare systems. If a
sible, an individual, facility-based exer- CAH is part of a healthcare system
cise. If the CAH experiences an actual consisting of multiple separately cer-
natural or man-made emergency that tified healthcare facilities that elects
requires activation of the emergency to have a unified and integrated emer-
plan, the CAH is exempt from engaging gency preparedness program, the CAH
in a community-based or individual, fa- may choose to participate in the
cility-based full-scale exercise for 1 healthcare system’s coordinated emer-
year following the onset of the actual gency preparedness program. If elected,
event. the unified and integrated emergency
(ii) Conduct an additional exercise preparedness program must do all of
that may include, but is not limited to the following:
the following: (1) Demonstrate that each separately
(A) A second full-scale exercise that certified facility within the system ac-
is community-based or individual, fa-
tively participated in the development
cility-based.
of the unified and integrated emer-
(B) A tabletop exercise that includes
gency preparedness program.
a group discussion led by a facilitator,
using a narrated, clinically-relevant (2) Be developed and maintained in a
emergency scenario, and a set of prob- manner that takes into account each
lem statements, directed messages, or separately certified facility’s unique
prepared questions designed to chal- circumstances, patient populations,
lenge an emergency plan. and services offered.
(iii) Analyze the CAH’s response to (3) Demonstrate that each separately
and maintain documentation of all certified facility is capable of actively
drills, tabletop exercises, and emer- using the unified and integrated emer-
gency events, and revise the CAH’s gency preparedness program and is in
emergency plan, as needed. compliance with the program.
(e) Emergency and standby power sys- (4) Include a unified and integrated
tems. The CAH must implement emer- emergency plan that meets the require-
gency and standby power systems ments of paragraphs (a)(2), (3), and (4)
212
of this section. The unified and inte- (vii) NFPA 101, Life Safety Code, 2012
grated emergency plan must also be edition, issued August 11, 2011.
based on and include— (viii) TIA 12–1 to NFPA 101, issued
(i) A documented community–based August 11, 2011.
risk assessment, utilizing an all-haz- (ix) TIA 12–2 to NFPA 101, issued Oc-
ards approach. tober 30, 2012.
(ii) A documented individual facility- (x) TIA 12–3 to NFPA 101, issued Oc-
based risk assessment for each sepa- tober 22, 2013.
rately certified facility within the (xi) TIA 12–4 to NFPA 101, issued Oc-
health system, utilizing an all-hazards tober 22, 2013.
approach. (xii) NFPA 110, Standard for Emer-
(5) Include integrated policies and gency and Standby Power Systems,
procedures that meet the requirements 2010 edition, including TIAs to chapter
set forth in paragraph (b) of this sec- 7, issued August 6, 2009.
tion, a coordinated communication (2) [Reserved]
plan and training and testing programs
that meet the requirements of para- [81 FR 64036, Sept. 16, 2016; 81 FR 80594, Nov.
16, 2016]
graphs (c) and (d) of this section, re-
spectively.
(g) The standards incorporated by Organizational structure.
for incorporation by reference by the (a) Standard: Governing body or re-
Director of the Office of the Federal sponsible individual. The CAH has a gov-
Register in accordance with 5 U.S.C. erning body or an individual that as-
552(a) and 1 CFR part 51. You may ob- sumes full legal responsibility for de-
tain the material from the sources list- termining, implementing and moni-
ed below. You may inspect a copy at toring policies governing the CAH’s
the CMS Information Resource Center, total operation and for ensuring that
7500 Security Boulevard, Baltimore, those policies are administered so as to
MD or at the National Archives and provide quality health care in a safe
Records Administration (NARA). For environment.
information on the availability of this (b) Standard: Disclosure. The CAH dis-
material at NARA, call 202–741–6030, or closes the names and addresses of—
go to: http://www.archives.gov/ (1) Its owners, or those with a con-
federallregister/ trolling interest in the CAH or in any
codeloflfederallregulations/ subcontractor in which the CAH di-
ibrllocations.html. If any changes in rectly or indirectly has a 5 percent or
this edition of the Code are incor- more ownership interest, in accordance
porated by reference, CMS will publish with subpart C of part 420 of this chap-
a document in the FEDERAL REGISTER ter;
to announce the changes. (2) The person principally responsible
(1) National Fire Protection Associa- for the operation of the CAH; and
tion, 1 Batterymarch Park, Quincy, (3) The person responsible for med-
MA 02169, www.nfpa.org, 1.617.770.3000. ical direction.
(i) NFPA 99, Health Care Facilities [58 FR 30671, May 26, 1993, as amended at 62
Code, 2012 edition, issued August 11, FR 46037, Aug. 29, 1997]
2011.
(ii) Technical interim amendment § 485.631 Condition of participation:
(TIA) 12–2 to NFPA 99, issued August Staffing and staff responsibilities.
11, 2011. (a) Standard: Staffing—(1) The CAH
(iii) TIA 12–3 to NFPA 99, issued Au- has a professional health care staff
gust 9, 2012. that includes one or more doctors of
(iv) TIA 12–4 to NFPA 99, issued medicine or osteopathy, and may in-
March 7, 2013. clude one or more physician assistants,
(v) TIA 12–5 to NFPA 99, issued Au- nurse practitioners, or clinical nurse
gust 1, 2013. specialists.

(vi) TIA 12–6 to NFPA 99, issued (2) Any ancillary personnel are super-
March 3, 2014. vised by the professional staff.
213
§ 485.635 42 CFR Ch. IV (10–1–17 Edition)
(3) The staff is sufficient to provide ant, the nurse practitioner, or clinical
the services essential to the operation nurse specialist members of the CAH’s
of the CAH. staff—
(4) A doctor of medicine or osteop- (i) Participate in the development,
athy, nurse practitioner, clinical nurse execution and periodic review of the
specialist, or physician assistant is written policies governing the services
available to furnish patient care serv- the CAH furnishes; and
ices at all times the CAH operates. (ii) Participate with a doctor of med-
(5) A registered nurse, clinical nurse icine or osteopathy in a periodic review
specialist, or licensed practical nurse is of the patients’ health records.
on duty whenever the CAH has one or (2) The physician assistant, nurse
more inpatients. practitioner, or clinical nurse spe-
(b) Standard: Responsibilities of the
cialist performs the following func-
doctor of medicine or osteopathy. (1) The
tions to the extent they are not being
doctor of medicine or osteopathy—
performed by a doctor of medicine or
(i) Provides medical direction for the
osteopathy:
CAH’s health care activities and con-
sultation for, and medical supervision (i) Provides services in accordance
of, the health care staff; with the CAH’s policies.
(ii) In conjunction with the physician (ii) Arranges for, or refers patients
assistant and/or nurse practitioner to, needed services that cannot be fur-
member(s), participates in developing, nished at the CAH, and assures that
executing, and periodically reviewing adequate patient health records are
the CAH’s written policies governing maintained and transferred as required
the services it furnishes. when patients are referred.
(iii) In conjunction with the physi- (3) Whenever a patient is admitted to
cian assistant and/or nurse practitioner the CAH by a nurse practitioner, physi-
members, periodically reviews the cian assistant, or clinical nurse spe-
CAH’s patient records, provides med- cialist, a doctor of medicine or osteop-
ical orders, and provides medical care athy on the staff of the CAH is notified
services to the patients of the CAH; of the admission.
and
(iv) Periodically reviews and signs
FR 46037, Aug. 29, 1997; 70 FR 68728, Nov. 10,
the records of all inpatients cared for 2005; 79 FR 27155, May 12, 2014]
by nurse practitioners, clinical nurse
specialists, certified nurse midwives, or § 485.635 Condition of participation:
physician assistants. Provision of services.
(v) Periodically reviews and signs a
(a) Standard: Patient care policies. (1)
sample of outpatient records of pa-
The CAH’s health care services are fur-
tients cared for by nurse practitioners,
clinical nurse specialists, certified nished in accordance with appropriate
nurse midwives, or physician assistants written policies that are consistent
only to the extent required under State with applicable State law.
law where State law requires record re- (2) The policies are developed with
views or co-signatures, or both, by a the advice of members of the CAH’s
collaborating physician. professional healthcare staff, including
(2) A doctor of medicine or osteop- one or more doctors of medicine or os-
athy is present for sufficient periods of teopathy and one or more physician as-
time to provide medical direction, con- sistants, nurse practitioners, or clin-
sultation, and supervision for the serv- ical nurse specialists, if they are on
ices provided in the CAH, and is avail- staff under the provisions of
able through direct radio or telephone § 485.631(a)(1).
communication or electronic commu- (3) The policies include the following:
nication for consultation, assistance (i) A description of the services the
with medical emergencies, or patient CAH furnishes, including those fur-
referral. nished through agreement or arrange-
(c) Standard: Physician assistant, nurse ment.

practitioner, and clinical nurse specialist (ii) Policies and procedures for emer-
responsibilities. (1) The physician assist- gency medical services.
214
(iii) Guidelines for the medical man- treatment of the patient that meet the
agement of health problems that in- standards imposed under section 353 of
clude the conditions requiring medical the Public Health Service Act (42
consultation and/or patient referral, U.S.C. 236a). (See the laboratory re-
the maintenance of health care quirements specified in part 493 of this
records, and procedures for the periodic chapter.) The services provided include
review and evaluation of the services the following:
furnished by the CAH. (i) Chemical examination of urine by
(iv) Rules for the storage, handling, stick or tablet method or both (includ-
dispensation, and administration of ing urine ketones).
drugs and biologicals. These rules must (ii) Hemoglobin or hematocrit.
provide that there is a drug storage (iii) Blood glucose.
area that is administered in accordance
(iv) Examination of stool specimens
with accepted professional principles,
for occult blood.
that current and accurate records are
kept of the receipt and disposition of (v) Pregnancy tests.
all scheduled drugs, and that outdated, (vi) Primary culturing for trans-
mislabeled, or otherwise unusable mittal to a certified laboratory.
drugs are not available for patient use. (3) Radiology services. Radiology serv-
(v) Procedures for reporting adverse ices furnished by the CAH are provided
drug reactions and errors in the admin- by personnel qualified under State law,
istration of drugs. and do not expose CAH patients or per-
(vi) A system for identifying, report- sonnel to radiation hazards.
ing, investigating and controlling in- (4) Emergency procedures. In accord-
fections and communicable diseases of ance with requirements of § 485.618, the
patients and personnel. CAH provides medical services as a
(vii) Procedures that ensure that the first response to common life-threat-
nutritional needs of inpatients are met ening injuries and acute illness.
in accordance with recognized dietary (c) Standard: Services provided through
practices and the orders of the practi- agreements or arrangements. (1) The CAH
tioner responsible for the care of the has agreements or arrangements (as
patients, and that the requirement of appropriate) with one or more pro-
§ 483.25(g) of this chapter is met with viders or suppliers participating under
respect to inpatients receiving Medicare to furnish other services to
posthospital SNF care. its patients, including—
(4) These policies are reviewed at (i) Services of doctors of medicine or
least annually by the group of profes- osteopathy;
sional personnel required under para-
(ii) Additional or specialized diag-
graph (a)(2) of this section, and re-
nostic and clinical laboratory services
viewed as necessary by the CAH.
that are not available at the CAH; and
(b) Standard: Patient services—(1) Gen-
eral: (i) The CAH provides those diag- (iii) Food and other services to meet
nostic and therapeutic services and inpatients’ nutritional needs to the ex-
supplies that are commonly furnished tent these services are not provided di-
in a physician’s office or at another rectly by the CAH.
entry point into the health care deliv- (2) If the agreements or arrange-
ery system, such as a low intensity ments are not in writing, the CAH is
hospital outpatient department or able to present evidence that patients
emergency department. These CAH referred by the CAH are being accepted
services include medical history, phys- and treated.
ical examination, specimen collection, (3) The CAH maintains a list of all
assessment of health status, and treat- services furnished under arrangements
ment for a variety of medical condi- or agreements. The list describes the
tions. nature and scope of the services pro-
(ii) The CAH furnishes acute care in- vided.
patient services. (4) The person principally responsible
(2) Laboratory services. The CAH pro- for the operation of the CAH under
vides basic laboratory services essen- § 485.627(b)(2) of this chapter is also re-
tial to the immediate diagnosis and sponsible for the following:
215
§ 485.638 42 CFR Ch. IV (10–1–17 Edition)
(i) Services furnished in the CAH rights of patients, including those set-
whether or not they are furnished ting forth any clinically necessary or
under arrangements or agreements. reasonable restriction or limitation
(ii) Ensuring that a contractor of that the CAH may need to place on
services (including one for shared serv- such rights and the reasons for the
ices and joint ventures) furnishes serv- clinical restriction or limitation. A
ices that enable the CAH to comply CAH must meet the following require-
with all applicable conditions of par- ments:
ticipation and standards for the con- (1) Inform each patient (or support
tracted services. person, where appropriate) of his or her
(5) In the case of distant-site physi- visitation rights, including any clinical
cians and practitioners providing tele- restriction or limitation on such
medicine services to the CAH’s pa- rights, in advance of furnishing patient
tients under a written agreement be- care whenever possible.
tween the CAH and a distant-site tele- (2) Inform each patient (or support
medicine entity, the distant-site tele- person, where appropriate) of the right,
medicine entity is not required to be a subject to his or her consent, to receive
Medicare-participating provider or sup- the visitors whom he or she designates,
plier. including, but not limited to, a spouse,
(d) Standard: Nursing services. Nursing a domestic partner (including a same-
services must meet the needs of pa- sex domestic partner), another family
tients. member, or a friend, and his or her
(1) A registered nurse must provide right to withdraw or deny such consent
(or assign to other personnel) the nurs- at any time.
ing care of each patient, including pa- (3) Not restrict, limit, or otherwise
tients at a SNF level of care in a deny visitation privileges on the basis
swing-bed CAH. The care must be proof race, color, national origin, religion,
vided in accordance with the patient’s sex, gender identity, sexual orienta-
needs and the specialized qualifications tion, or disability.
and competence of the staff available. (4) Ensure that all visitors enjoy full
(2) A registered nurse or, where per- and equal visitation privileges con-
mitted by State law, a physician as- sistent with patient preferences.
sistant, must supervise and evaluate
[58 FR 30671, May 26, 1993; 58 FR 49935, Sept.
the nursing care for each patient, in-
24, 1993, as amended at 59 FR 45403, Sept. 1,
cluding patients at a SNF level of care 1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408,
in a swing-bed CAH. Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 75 FR
(3) All drugs, biologicals, and intra- 70844, Nov. 19, 2010; 76 FR 25564, May 5, 2011;
venous medications must be adminis- 77 FR 29076, May 16, 2012; 78 FR 50970, Aug. 19,
tered by or under the supervision of a 2013; 79 FR 27156, May 12, 2014; 81 FR 68871,
registered nurse, a doctor of medicine Oct. 4, 2016; 82 FR 32260, July 13, 2017]
or osteopathy, or, where permitted by
State law, a physician assistant, in ac- § 485.638 Conditions of participation:
Clinical records.
cordance with written and signed or-
ders, accepted standards of practice, (a) Standard: Records system—(1) The
and Federal and State laws. CAH maintains a clinical records sys-
(4) A nursing care plan must be devel- tem in accordance with written poli-
oped and kept current for each inpa- cies and procedures.
tient. (2) The records are legible, complete,
(e) Standard: Rehabilitation Therapy accurately documented, readily acces-
Services. Physical therapy, occupa- sible, and systematically organized.
tional therapy, and speech-language (3) A designated member of the pro-
pathology services furnished at the fessional staff is responsible for main-
CAH, if provided, are provided by staff taining the records and for ensuring
qualified under State law, and con- that they are completely and accu-
sistent with the requirements for ther- rately documented, readily accessible,
apy services in § 409.17 of this subpart. and systematically organized.
(f) Standard: Patient visitation rights. (4) For each patient receiving health
A CAH must have written policies and care services, the CAH maintains a
procedures regarding the visitation record that includes, as applicable—
216
(i) Identification and social data, evi- gery for CAH patients, in accordance
dence of properly executed informed with its approved policies and proce-
consent forms, pertinent medical his- dures, and with State scope of practice
tory, assessment of the health status laws. Surgery is performed only by—
and health care needs of the patient, (1) A doctor of medicine or osteop-
and a brief summary of the episode, athy, including an osteopathic practi-
disposition, and instructions to the pa- tioner recognized under section
tient; 1101(a)(7) of the Act;
(ii) Reports of physical examinations, (2) A doctor of dental surgery or den-
diagnostic and laboratory test results, tal medicine; or
including clinical laboratory services, (3) A doctor of podiatric medicine.
and consultative findings; (b) Anesthetic risk and evaluation. (1)
(iii) All orders of doctors of medicine A qualified practitioner, as specified in
or osteopathy or other practitioners, paragraph (a) of this section, must ex-
reports of treatments and medications, amine the patient immediately before
nursing notes and documentation of surgery to evaluate the risk of the pro-
complications, and other pertinent in- cedure to be performed.
formation necessary to monitor the pa- (2) A qualified practitioner, as speci-
tient’s progress, such as temperature fied in paragraph (c) of this section,
graphics, progress notes describing the must examine each patient before sur-
patient’s response to treatment; and gery to evaluate the risk of anesthesia.
(iv) Dated signatures of the doctor of (3) Before discharge from the CAH,
medicine or osteopathy or other health each patient must be evaluated for
care professional. proper anesthesia recovery by a quali-
(b) Standard: Protection of record infor- fied practitioner, as specified in para-
mation—(1) The CAH maintains the graph (c) of this section.
confidentiality of record information (c) Administration of anesthesia. The
and provides safeguards against loss, CAH designates the person who is al-
destruction, or unauthorized use. lowed to administer anesthesia to CAH
(2) Written policies and procedures patients in accordance with its ap-
govern the use and removal of records proved policies and procedures and
from the CAH and the conditions for with State scope-of-practice laws.
the release of information. (1) Anesthesia must be administered
(3) The patient’s written consent is by only—
required for release of information not (i) A qualified anesthesiologist;
required by law. (ii) A doctor of medicine or osteop-
(c) Standard: Retention of records. The athy other than an anesthesiologist;
records are retained for at least 6 years including an osteopathic practitioner
from date of last entry, and longer if recognized under section 1101(a)(7) of
required by State statute, or if the the Act;
records may be needed in any pending (iii) A doctor of dental surgery or
proceeding. dental medicine;
[58 FR 30671, May 26, 1993, as amended at 62 (iv) A doctor of podiatric medicine;
FR 46037, Aug. 29, 1997] (v) A certified registered nurse anes-
thetist (CRNA), as defined in § 410.69(b)
§ 485.639 Condition of participation: of this chapter;
Surgical services. (vi) An anesthesiologist’s assistant,
If a CAH provides surgical services, as defined in § 410.69(b) of this chapter;
surgical procedures must be performed or
in a safe manner by qualified practi- (vii) A supervised trainee in an ap-
tioners who have been granted clinical proved educational program, as de-
privileges by the governing body, or re- scribed in § 413.85 or § 413.86 of this
sponsible individual, of the CAH in ac- chapter.
cordance with the designation require- (2) In those cases in which a CRNA
ments under paragraph (a) of this sec- administers the anesthesia, the anes-
tion. thetist must be under the supervision
(a) Designation of qualified practi- of the operating practitioner except as

tioners. The CAH designates the practi- provided in paragraph (e) of this sec-
tioners who are allowed to perform sur- tion. An anesthesiologist’s assistant
217
§ 485.641 42 CFR Ch. IV (10–1–17 Edition)
who administers anesthesia must be (b) Standard: Quality assurance. The

under the supervision of an anesthe- CAH has an effective quality assurance
siologist. program to evaluate the quality and
(d) Discharge. All patients are dis- appropriateness of the diagnosis and
charged in the company of a respon- treatment furnished in the CAH and of
sible adult, except those exempted by the treatment outcomes. The program
the practitioner who performed the requires that—
surgical procedure. (1) All patient care services and other
(e) Standard: State exemption. (1) A services affecting patient health and
CAH may be exempted from the re- safety, are evaluated;
quirement for physician supervision of (2) Nosocomial infections and medi-
CRNAs as described in paragraph (c)(2) cation therapy are evaluated;
of this section, if the State in which (3) The quality and appropriateness
the CAH is located submits a letter to of the diagnosis and treatment fur-
CMS signed by the Governor, following nished by nurse practitioners, clinical
consultation with the State’s Boards of nurse specialists, and physician assist-
Medicine and Nursing, requesting ex- ants at the CAH are evaluated by a
emption from physician supervision for member of the CAH staff who is a doc-
CRNAs. The letter from the Governor tor of medicine or osteopathy or by an-
must attest that he or she has con- other doctor of medicine or osteopathy
sulted with the State Boards of Medi- under contract with the CAH;
cine and Nursing about issues related (4) The quality and appropriateness
to access to and the quality of anes- of the diagnosis and treatment fur-
thesia services in the State and has nished by doctors of medicine or oste-
concluded that it is in the best inter- opathy at the CAH are evaluated by—
ests of the State’s citizens to opt-out of (i) One hospital that is a member of
the current physician supervision re- the network, when applicable;
quirement, and that the opt-out is con- (ii) One QIO or equivalent entity;
sistent with State law. (iii) One other appropriate and quali-
(2) The request for exemption and fied entity identified in the State rural
recognition of State laws and the with- health care plan;
drawal of the request may be sub- (iv) In the case of distant-site physi-
mitted at any time, and are effective cians and practitioners providing tele-
upon submission. medicine services to the CAH’s pa-
tients under a written agreement be-
tween the CAH and a distant-site hos-
FR 46037, Aug. 29, 1997; 66 FR 39938, Aug. 1,
2001; 66 FR 56769, Nov. 13, 2001; 77 FR 29076,
pital, the distant-site hospital; or
May 16, 2012] (v) In the case of distant-site physi-
cians and practitioners providing tele-
§ 485.641 Condition of participation: medicine services to the CAH’s pa-
Periodic evaluation and quality as- tients under a written agreement be-
surance review. tween the CAH and a distant-site tele-
(a) Standard: Periodic evaluation—(1) medicine entity, one of the entities
The CAH carries out or arranges for a listed in paragraphs (b)(4)(i) through
periodic evaluation of its total pro- (iii) of this section; and
gram. The evaluation is done at least (5)(i) The CAH staff considers the
once a year and includes review of— findings of the evaluations, including
(i) The utilization of CAH services, any findings or recommendations of
including at least the number of pa- the QIO, and takes corrective action if
tients served and the volume of serv- necessary.
ices; (ii) The CAH also takes appropriate
(ii) A representative sample of both remedial action to address deficiencies
active and closed clinical records; and found through the quality assurance
(iii) The CAH’s health care policies. program.
(2) The purpose of the evaluation is (iii) The CAH documents the outcome
to determine whether the utilization of of all remedial action.
services was appropriate, the estab- [58 FR 30671, May 26, 1993, as amended at 62
lished policies were followed, and any FR 46037, Aug. 29, 1997; 63 FR 26359, May 12,
changes are needed. 1998; 76 FR 25564, May 5, 2011]
218
§ 485.643 Condition of participation: (f) For purposes of these standards,

Organ, tissue, and eye procurement. the term ‘‘organ’’ means a human kid-
The CAH must have and implement ney, liver, heart, lung, pancreas, or in-
written protocols that: testines (or multivisceral organs).
(a) Incorporate an agreement with an [65 FR 47110, Aug. 1, 2000, as amended at 66
OPO designated under part 486 of this FR 39938, Aug. 1, 2001]
chapter, under which it must notify, in
a timely manner, the OPO or a third § 485.645 Special requirements for
party designated by the OPO of individ- CAH providers of long-term care
uals whose death is imminent or who services (‘‘swing-beds’’)
have died in the CAH. The OPO deter- A CAH must meet the following re-
mines medical suitability for organ do- quirements in order to be granted an
nation and, in the absence of alter- approval from CMS to provided post-
native arrangements by the CAH, the hospital SNF care, as specified in
OPO determines medical suitability for § 409.30 of this chapter, and to be paid
tissue and eye donation, using the defi- for SNF-level services, in accordance
nition of potential tissue and eye donor with paragraph (c) of this section.
and the notification protocol developed (a) Eligibility. A CAH must meet the
in consultation with the tissue and eye following eligibility requirements:
banks identified by the CAH for this (1) The facility has been certified as a
purpose; CAH by CMS under § 485.606(b) of this
(b) Incorporate an agreement with at subpart; and
least one tissue bank and at least one (2) The facility provides not more
eye bank to cooperate in the retrieval, than 25 inpatient beds. Any bed of a
processing, preservation, storage and unit of the facility that is licensed as a
distribution of tissues and eyes, as may distinct-part SNF at the time the facil-
be appropriate to assure that all usable ity applies to the State for designation
tissues and eyes are obtained from po- as a CAH is not counted under para-
tential donors, insofar as such an graph (a) of this section.
agreement does not interfere with (b) Facilities participating as rural pri-
organ procurement; mary care hospitals (RPCHs) on Sep-
(c) Ensure, in collaboration with the tember 30, 1997. These facilities must
designated OPO, that the family of meet the following requirements:
each potential donor is informed of its (1) Notwithstanding paragraph (a) of
option to either donate or not donate this section, a CAH that participated
organs, tissues, or eyes. The individual in Medicare as a RPCH on September
designated by the CAH to initiate the 30, 1997, and on that date had in effect
request to the family must be a des- an approval from CMS to use its inpa-
ignated requestor. A designated re- tient facilities to provide post-hospital
questor is an individual who has com- SNF care may continue in that status
pleted a course offered or approved by under the same terms, conditions and
the OPO and designed in conjunction limitations that were applicable at the
with the tissue and eye bank commu- time those approvals were granted.
nity in the methodology for approach- (2) A CAH that was granted swing-bed
ing potential donor families and re- approval under paragraph (b)(1) of this
questing organ or tissue donation; section may request that its applica-
(d) Encourage discretion and sensi- tion to be a CAH and swing-bed pro-
tivity with respect to the cir- vider be reevaluated under paragraph
cumstances, views, and beliefs of the (a) of this section. If this request is ap-
families of potential donors; proved, the approval is effective not
(e) Ensure that the CAH works coop- earlier than October 1, 1997. As of the
eratively with the designated OPO, tis- date of approval, the CAH no longer
sue bank and eye bank in educating has any status under paragraph (b)(1)
staff on donation issues, reviewing of this section and may not request re-
death records to improve identification instatement under paragraph (b)(1) of
of potential donors, and maintaining this section.
potential donors while necessary test- (c) Payment. Payment for inpatient
ing and placement of potential donated RPCH services to a CAH that has quali-
organs, tissues, and eyes take place. fied as a CAH under the provisions in
219
§ 485.647 42 CFR Ch. IV (10–1–17 Edition)
paragraph (a) of this section is made in (9) Nutrition (§ 483.25(g)(1) and (g)(2)
accordance with § 413.70 of this chapter. of this chapter).
Payment for post-hospital SNF-level of [63 FR 26359, May 12, 1998, as amended at 64
care services is made in accordance FR 41544, July 30, 1999; 67 FR 50120, Aug. 1,
with the payment provisions in § 413.114 2002; 69 FR 49272, Aug. 11, 2004; 81 FR 68871,
of this chapter. Oct. 4, 2016; 82 FR 32260, July 13, 2017]
(d) SNF services. The CAH is substan-
tially in compliance with the following psychiatric and rehabilitation dis-
SNF requirements contained in subpart tinct part units.
B of part 483 of this chapter: (a) Conditions. (1) If a CAH provides
(1) Resident rights (§ 483.10(b)(7), inpatient psychiatric services in a dis-
(c)(1), (c)(2)(iii), (c)(6), (d), (e)(2), (e)(4), tinct part unit, the services furnished
(f)(4)(ii), (f)(4)(iii), (f)(9), (g)(8), (g)(17), by the distinct part unit must comply
(g)(18) introductory text, (h) of this with the hospital requirements speci-
chapter). fied in subparts A, B, C, and D of part
(2) Admission, transfer, and discharge 482 of this subchapter, the common re-
rights (§ 483.5 definition of transfer & quirements of § 412.25(a)(2) through (f)
discharge, § 483.15(c)(1), (c)(2), (c)(3), of part 412 of this chapter for hospital
(c)(4), (c)(5), (c)(7), (c)(8), and (c)(9) of units excluded from the prospective
this chapter). payment systems, and the additional
(3) Freedom from abuse, neglect and requirements of § 412.27 of part 412 of
exploitation (§ 483.12(a)(1), (a)(2), this chapter for excluded psychiatric
(a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), units.
(2) If a CAH provides inpatient reha-
(c)(1), (c)(2), (c)(3), and (c)(4) of this
bilitation services in a distinct part
chapter). unit, the services furnished by the dis-
(4) Patient activities (§ 483.24(c) of tinct part unit must comply with the
this chapter), except that the services hospital requirements specified in sub-
may be directed either by a qualified parts A, B, C, and D of part 482 of this
professional meeting the requirements subchapter, the common requirements
of § 483.24(c)(2), or by an individual on of § 412.25(a)(2) through (f) of part 412 of
the facility staff who is designated as this chapter for hospital units excluded
the activities director and who serves from the prospective payments sys-
in consultation with a therapeutic tems, and the additional requirements
recreation specialist, occupational of §§ 412.29 and § 412.30 of part 412 of this
therapist, or other professional with chapter related specifically to rehabili-
experience or education in recreational tation units.
therapy. (b) Eligibility requirements. (1) To be
(5) Social services (§ 483.40(d) and eligible to receive Medicare payments
§ 483.70(p) of this chapter). for psychiatric or rehabilitation serv-
(6) Comprehensive assessment, com- ices as a distinct part unit, the facility
provides no more than 10 beds in the
prehensive care plan, and discharge
distinct part unit.
planning (§ 483.20(b), and § 483.21(b) and
(2) The beds in the distinct part are
(c)(2) of this chapter), except that the excluded from the 25 inpatient-bed
CAH is not required to use the resident count limit specified in § 485.620(a).
assessment instrument (RAI) specified (3) The average annual 96-hour length
by the State that is required under of stay requirement specified under
§ 483.20(b), or to comply with the re- § 485.620(b) does not apply to the 10 beds
quirements for frequency, scope, and in the distinct part units specified in
number of assessments prescribed in paragraph (b)(1) of this section, and ad-
§ 413.343(b) of this chapter). missions and days of inpatient care in
(7) Specialized rehabilitative services the distinct part units are not taken
(§ 483.65 of this chapter). into account in determining the CAH’s
(8) Dental services (§ 483.55 of this compliance with the limits on the
chapter). number of beds and length of stay in

§ 485.620.
[69 FR 49272, Aug. 11, 2004]
220
Subpart G [Reserved] medical services, and in certain cases,

therapeutic services.
Rehabilitation agency. An agency
Subpart H—Conditions of Partici- that—
pation for Clinics, Rehabilita- (1) Provides an integrated inter-
tion Agencies, and Public disciplinary rehabilitation program de-
Health Agencies as Providers signed to upgrade the physical func-
of Outpatient Physical Ther- tioning of handicapped disabled indi-
apy and Speech-Language viduals by bringing specialized reha-
Pathology Services bilitation staff together to perform as
a team; and
§ 485.701 Basis and scope. (2) Provides at least physical therapy
This subpart implements section or speech-language pathology services.
1861(p)(4) of the Act, which— Supervision. Authoritative procedural
(a) Defines outpatient physical ther- guidance that is for the accomplish-
apy and speech pathology services; ment of a function or activity and
(b) Imposes requirements with re- that—
spect to adequate program, facilities, (1) Includes initial direction and peri-
policies, staffing, and clinical records; odic observation of the actual perform-
and ance of the function or activity; and
(c) Authorizes the Secretary to estab- (2) Is furnished by a qualified per-
lish by regulation other health and son—
safety requirements. (i) Whose sphere of competence en-
compasses the particular function or
[60 FR 2327, Jan. 9, 1995] activity; and
(ii) Who (unless otherwise provided in
§ 485.703 Definitions. this subpart) is on the premises if the
Clinic. A facility that is established person performing the function or ac-
primarily to furnish outpatient physi- tivity does not meet the assistant-level
cian services and that meets the fol- practitioner qualifications specified in
lowing tests of physician involvement: § 485.705.
(1) The medical services are furnished
[41 FR 20865, May 21, 1976. Redesignated at 42
by a group of three or more physicians FR 52826, Sept. 30, 1977, and amended at 53
practicing medicine together. FR 12015, Apr. 12, 1988; 54 FR 38679, Sept. 20,
(2) A physician is present during all 1989. Redesignated and amended at 60 FR
hours of operation of the clinic to fur- 2326, 2327, Jan. 9, 1995; 60 FR 50447, Sept. 29,
nish medical services, as distinguished 1995; 73 FR 69941, Nov. 19, 2008]
from purely administrative services.
Extension location. A location or site § 485.705 Personnel qualifications.
from which a rehabilitation agency (a) General qualification requirements.
provides services within a portion of Except as specified in paragraphs (b)
the total geographic area served by the and (c) of this section, all personnel
primary site. The extension location is who are involved in the furnishing of
part of the rehabilitation agency. The outpatient physical therapy, occupa-
extension location should be located tional therapy, and speech-language
sufficiently close to share administra- pathology services directly by or under
tion, supervision, and services in a arrangements with an organization
manner that renders it unnecessary for must be legally authorized (licensed or,
the extension location to independ- if applicable, certified or registered) to
ently meet the conditions of participa- practice by the State in which they
tion as a rehabilitation agency. perform the functions or actions, and
Organization. A clinic, rehabilitation must act only within the scope of their
agency, or public health agency. State license or State certification or
Public health agency. An official agen- registration.
cy established by a State or local gov- (b) Exception for Federally defined
ernment, the primary function of qualifications. The following Federally
which is to maintain the health of the defined qualifications must be met:

population served by performing envi- (1) For a physician, the qualifications
ronmental health services, preventive and conditions as defined in section
221
§ 485.705 42 CFR Ch. IV (10–1–17 Edition)
1861(r) of the Act and the requirements (ii) Be certified as a nurse practi-
in part 484 of this chapter. tioner by a recognized national certi-
(2) For a speech-language pathologist, fying body that has established stand-
the qualifications specified in section ards for nurse practitioners; or
1861(11)(1) of the Act and the require- (iii) Be a registered professional
ments in part 484 of this chapter. nurse who is authorized by the State in
(c) Exceptions when no State Licensing which the services are furnished to
laws or State certification or registration practice as a nurse practitioner in ac-
requirements exist. If no State licensing cordance with State law and have been
laws or State certification or registra- granted a Medicare billing number as a
tion requirements exist for the profes- nurse practitioner by December 31,
sion, the following requirements must 2000; or
be met—
(iv) Be a nurse practitioner who on or
(1) An administrator is a person who
after January 1, 2001, applies for a
has a bachelor’s degree and:
Medicare billing number for the first
(i) Has experience or specialized
time and meets the standards for nurse
training in the administration of
practitioners in paragraphs (c)(8)(i) and
health institutions or agencies; or
(c)(8)(ii) of this section; or
(ii) Is qualified and has experience in
one of the professional health dis- (v) Be a nurse practitioner who on or
ciplines. after January 1, 2003, applies for a
(2) An occupational therapist must Medicare billing number for the first
meet the requirements in part 484 of time and possesses a master’s degree in
this chapter. nursing and meets the standards for
(3) An occupational therapy assistant nurse practitioners in paragraphs
must meet the requirements in part 484 (b)(1)(i) and (b)(1)(ii) of this section.
of this chapter. (9) A clinical nurse specialist is a per-
(4) A physical therapist must meet the son who must:
requirements in part 484 of this chap- (i) Be a registered nurse who is cur-
ter. rently licensed to practice in the State
(5) A physical therapist assistant must where he or she practices and be au-
meet the requirements in part 484 of thorized to perform the services of a
this chapter. clinical nurse specialist in accordance
(6) A social worker must meet the re- with State law;
quirements in part 484 of this chapter. (ii) Have a master’s degree in a de-
(7) A vocational specialist is a person fined clinical area of nursing from an
who has a baccalaureate degree and— accredited educational institution;
(i) Two years experience in voca- and,
tional counseling in a rehabilitation (iii) Be certified as a clinical nurse
setting such as a sheltered workshop, specialist by the American Nurses
State employment service agency, etc.; Credentialing Center.
or (10) A physician assistant is a person
(ii) At least 18 semester hours in vo- who:
cational rehabilitation, educational or (i) Has graduated from a physician
vocational guidance, psychology, social assistant educational program that is
work, special education or personnel accredited by the Commission on Ac-
administration, and 1 year of experi- creditation of Allied Health Education
ence in vocational counseling in a re- Programs; or
habilitation setting; or
(ii) Has passed the national certifi-
(iii) A master’s degree in vocational cation examination that is adminis-
counseling.
tered by the National Commission on
(8) A nurse practitioner is a person
Certification of Physician Assistants;
who must:
and
(i) Be a registered professional nurse
(iii) Is licensed by the State to prac-
who is authorized by the State in
tice as a physician assistant.

which the services are furnished to
practice as a nurse practitioner in ac- [63 FR 58912, Nov. 2, 1998; 64 FR 25457, May 12,
cordance with State law; and 1999; 64 FR 59442, Nov. 2, 1999]
222
§ 485.707 Condition of participation: that are kept current. Personnel

Compliance with Federal, State, records include the qualifications of all
and local laws. professional and assistant level per-
The organization and its staff are in sonnel, as well as evidence of State li-
compliance with all applicable Federal, censure if applicable.
State, and local laws and regulations. (d) Standard: Patient care policies. Pa-
(a) Standard: Licensure of organization. tient care practices and procedures are
In any State in which State or applica- supported by written policies estab-
ble local law provides for the licensing lished by a group of professional per-
of organizations, a clinic, rehabilita- sonnel including one or more physi-
tion agency, or public health agency is cians associated with the clinic or re-
licensed in accordance with applicable habilitation agency, one or more quali-
laws. fied physical therapists (if physical
(b) Standard: Licensure or registration therapy services are provided), and one
of personnel. Staff of the organization or more qualified speech pathologists
are licensed or registered in accordance (if speech pathology services are pro-
with applicable laws. vided). The policies govern the out-
[41 FR 20865, May 21, 1976. Redesignated at 42 patient physical therapy and/or speech
FR 52826, Sept. 30, 1977. Further redesignated pathology services and related services
and amended at 60 FR 2326, 2327, Jan. 9, 1995] that are provided. These policies are
§ 485.709 Condition of participation: evaluated at least annually by the
Administrative management. group of professional personnel, and re-
vised as necessary based upon this
The clinic or rehabilitation agency
evaluation.
has an effective governing body that is
legally responsible for the conduct of [41 FR 20865, May 21, 1976. Redesignated at 42
the clinic or rehabilitation agency. The FR 52826, Sept. 30, 1977, and amended at 53
governing body designates an adminis- FR 12015, Apr. 12, 1988. Redesignated and
trator, and establishes administrative amended at 60 FR 2326, 2327, Jan. 9, 1995; 60
policies. FR 50447, Sept. 29, 1995]
(a) Standard: Governing body. There is
a governing body (or designated per- Plan of care and physician involve-
son(s) so functioning) which assumes ment.
full legal responsibility for the overall
conduct of the clinic or rehabilitation For each patient in need of out-
agency and for compliance with appli- patient physical therapy or speech pa-
cable laws and regulations. The name thology services, there is a written
of the owner(s) of the clinic or rehabili- plan of care established and periodi-
tation agency is fully disclosed to the cally reviewed by a physician, or by a
State agency. In the case of corpora- physical therapist or speech patholo-
tions, the names of the corporate offi- gist respectively.
cers are made known. (a) Standard: Medical history and prior
(b) Standard: Administrator. The gov- treatment. The following are obtained
erning body— by the organization before or at the
(1) Appoints a qualified full-time ad- time of initiation of treatment:
ministrator; (1) The patient’s significant past his-
(2) Delegates to the administrator tory.
the internal operation of the clinic or (2) Current medical findings, if any.
rehabilitation agency in accordance (3) Diagnosis(es), if established.
with written policies;
(4) Physician’s orders, if any.
(3) Defines clearly the administra-
tor’s responsibilities for procurement (5) Rehabilitation goals, if deter-
and direction of personnel; and mined.
(4) Designates a competent individual (6) Contraindications, if any.
to act during temporary absence of the (7) The extent to which the patient is
administrator. aware of the diagnosis(es) and prog-
(c) Standard: Personnel policies. Per- nosis.

sonnel practices are supported by ap- (8) If appropriate, the summary of
propriate written personnel policies treatment furnished and results
223
§ 485.713 42 CFR Ch. IV (10–1–17 Edition)
achieved during previous periods of re- (iii) Administer tests and measure-
habilitation services or institutional- ments of strength, balance, endurance,
ization. range of motion, and activities of daily
(b) Standard: Plan of care. (1) For each living.
patient there is a written plan of care (2) A qualified physical therapist is
established by the physician or by the present or readily available to offer su-
physical therapist or speech-language pervision when a physical therapist as-
pathologist who furnishes the services. sistant furnishes services.
(2) The plan of care for physical ther- (i) If a qualified physical therapist is
apy or speech pathology services indi- not on the premises during all hours of
cates anticipated goals and specifies operation, patients are scheduled so as
for those services the— to ensure that the therapist is present
(i) Type; when special skills are needed, for ex-
(ii) Amount; ample, for evaluation and reevaluation.
(iii) Frequency; and (ii) When a physical therapist assist-
(iv) Duration. ant furnishes services off the organiza-
(3) The plan of care and results of tion’s premises, those services are su-
treatment are reviewed by the physi- pervised by a qualified physical thera-
cian or by the individual who estab-
pist who makes an onsite supervisory
lished the plan at least as often as the
visit at least once every 30 days.
patient’s condition requires, and the
indicated action is taken. (b) Standard: Facilities and equipment.
(4) Changes in the plan of care are The organization has the equipment
noted in the clinical record. If the pa- and facilities required to provide the
tient has an attending physician, the range of services necessary in the
therapist or speech-language patholo- treatment of the types of disabilities it
gist who furnishes the services prompt- accepts for service.
ly notifies him or her of any change in (c) Standard: Personnel qualified to
the patient’s condition or in the plan of provide physical therapy services. Phys-
care. ical therapy services are provided by,
(c) Standard: Emergency care. The re- or under the supervision of, a qualified
habilitation agency must establish pro- physical therapist. The number of
cedures to be followed by personnel in qualified physical therapists and quali-
an emergency, which cover immediate fied physical therapist assistants is
care of the patient, persons to be noti- adequate for the volume and diversity
fied, and reports to be prepared. of physical therapy services offered. A
[54 FR 38679, Sept. 20, 1989. Redesignated and qualified physical therapist is on the
amended at 60 FR 2326, 2327, Jan. 9, 1995; 63 premises or readily available during
FR 58913, Nov. 2, 1998; 73 FR 69941, Nov. 19, the operating hours of the organiza-
2008] tion.
(d) Standard: Supportive personnel. If
Physical therapy services. personnel are available to assist quali-
fied physical therapists by performing
If the organization offers physical services incident to physical therapy
therapy services, it provides an ade- that do not require professional knowl-
quate program of physical therapy and edge and skill, these personnel are in-
has an adequate number of qualified structed in appropriate patient care
personnel and the equipment necessary
services by qualified physical thera-
to carry out its program and to fulfill
pists who retain responsibility for the
its objectives.
treatment prescribed by the attending
(a) Standard: Adequate program. (1)
physician.
The organization is considered to have
an adequate outpatient physical ther- [41 FR 20865, May 21, 1976. Redesignated at 42
apy program if it can: FR 52826, Sept. 30, 1977. Further redesignated
(i) Provide services using therapeutic and amended at 60 FR 2326, 2327, Jan. 9, 1995;
exercise and the modalities of heat, 60 FR 50447, Sept. 29, 1995]

cold, water, and electricity;
(ii) Conduct patient evaluations; and
224
§ 485.715 Condition of participation: the contract must specify the term of

Speech pathology services. the contract, the manner of termi-
If speech pathology services are of- nation or renewal and provide that the
fered, the organization provides an ade- agency retains responsibility for the
quate program of speech pathology and control and supervision of the services.
has an adequate number of qualified [73 FR 69942, Nov. 19, 2008]
personnel and the equipment necessary
to carry out its program and to fulfill § 485.719 Condition of participation:
its objectives. Arrangements for physical therapy
(a) Standard: Adequate program. The and speech pathology services to be
organization is considered to have an performed by other than salaried
adequate outpatient speech pathology organization personnel.
program if it can provide the diag- (a) Conditions. If an organization pro-
nostic and treatment services to effec- vides outpatient physical therapy or
tively treat speech disorders. speech pathology services under an ar-
(b) Standard: Facilities and equipment. rangement with others, the services
The organization has the equipment are to be furnished in accordance with
and facilities required to provide the the terms of a written contract, which
range of services necessary in the provides that the organization retains
treatment of the types of speech dis- of professional and administrative re-
orders it accepts for service. sponsibility for, and control and super-
(c) Standard: Personnel qualified to vision of, the services.
provide speech pathology services. Speech (b) Standard: Contract provisions. The
pathology services are given or super- contract—
vised by a qualified speech pathologist (1) Specifies the term of the contract
and the number of qualified speech pa- and the manner of termination or re-
thologists is adequate for the volume newal;
and diversity of speech pathology serv-
(2) Requires that personnel who fur-
ices offered. At least one qualified
nish the services meet the require-
speech pathologist is present at all
ments that are set forth in this subpart
times when speech pathology services
for salaried personnel; and
are furnished.
(3) Provides that the contracting out-
[41 FR 20865, May 21, 1976. Redesignated at 42 side resource may not bill the patient
FR 52826, Sept. 30, 1977. Further redesignated or Medicare for the services. This limi-
and amended at 60 FR 2326, Jan. 9, 1995] tation is based on section 1861(w)(1) of
§ 485.717 Condition of participation: the Act, which provides that—
Rehabilitation program. (i) Only the provider may bill the
beneficiary for covered services fur-
This condition and standards apply
nished under arrangements; and
only to a rehabilitation agency’s own
patients, not to patients of hospitals, (ii) Receipt of Medicare payment by
skilled nursing facilities (SNFs), or the provider, on behalf of an entitled
Medicaid nursing facilities (NFs) to individual, discharges the liability of
which the agency furnishes services. the individual or any other person to
The hospital, SNF, or NF is responsible pay for those services.
for ensuring that qualified staff furnish [56 FR 46562, Sept. 13, 1991. Redesignated and
services for which they arrange or con- amended at 60 FR 2326, 2328, Jan. 9, 1995; 60
tract for their patients. The rehabilita- FR 50447, Sept. 29, 1995]
tion agency provides physical therapy
and speech-language pathology serv- § 485.721 Condition of participation:
ices to all of its patients who need Clinical records.
them. The organization maintains clinical
(a) Standard: Qualification of staff. records on all patients in accordance
The agency’s therapy services are fur- with accepted professional standards,
nished by qualified individuals as di- and practices. The clinical records are
rect services and/or services provided completely and accurately docu-
under contract. mented, readily accessible, and system-

(b) Standard: Arrangements for services. atically organized to facilitate retriev-
If services are provided under contract, ing and compiling information.
225
§ 485.723 42 CFR Ch. IV (10–1–17 Edition)
(a) Standard: Protection of clinical trieval of records for research or ad-

record information. The organization ministrative action.
recognizes the confidentiality of clin- (f) Standard: Location and facilities.
ical record information and provides The organization maintains adequate
safeguards against loss, destruction, or facilities and equipment, conveniently
unauthorized use. Written procedures located, to provide efficient processing
govern the use and removal of records of clinical records (reviewing, indexing,
and the conditions for release of infor- filing, and prompt retrieval).
mation. The patient’s written consent
is required for release of information [41 FR 20865, May 21, 1976. Redesignated at 42
not authorized by law. FR 52826, Sept. 30, 1977. Further redesignated
and amended at 60 FR 2326, Jan. 9, 1995]
(b) Standard: Content. The clinical
record contains sufficient information § 485.723 Condition of participation:
to identify the patient clearly, to jus- Physical environment.
tify the diagnosis(es) and treatment,
and to document the results accu- The building housing the organiza-
rately. All clinical records contain the tion is constructed, equipped, and
following general categories of data: maintained to protect the health and
(1) Documented evidence of the as- safety of patients, personnel, and the
sessment of the needs of the patient, of public and provides a functional, sani-
an appropriate plan of care, and of the tary, and comfortable environment.
care and services furnished. (a) Standard: Safety of patients. The
(2) Identification data and consent organization satisfies the following re-
forms. quirements:
(3) Medical history. (1) It complies with all applicable
(4) Report of physical examinations, State and local building, fire, and safe-
if any. ty codes.
(5) Observations and progress notes. (2) Permanently attached automatic
(6) Reports of treatments and clinical fire-extinguishing systems of adequate
findings. capacity are installed in all areas of
(7) Discharge summary including the premises considered to have special
final diagnosis(es) and prognosis. fire hazards. Fire extinguishers are
(c) Standard: Completion of records and conveniently located on each floor of
centralization of reports. Current clin- the premises. Fire regulations are
ical records and those of discharged pa- prominently posted.
tients are completed promptly. All (3) Doorways, passageways and stair-
clinical information pertaining to a pa- wells negotiated by patients are:
tient is centralized in the patient’s (i) Of adequate width to allow for
clinical record. Each physician signs easy movement of all patients (includ-
the entries that he or she makes in the ing those on stretchers or in wheel-
clinical record. chairs), (ii) free from obstruction at all
(d) Standard: Retention and preserva- times, and (iii) in the case of stair-
tion. Clinical records are retained for wells, equipped with firmly attached
at least: handrails on at least one side.
(1) The period determined by the re- (4) Lights are placed at exits and in
spective State statute, or the statute corridors used by patients and are sup-
of limitations in the State; or ported by an emergency power source.
(2) In the absence of a State statute— (5) A fire alarm system with local
(i) Five years after the date of dis- alarm capability and, where applicable,
charge; or an emergency power source, is func-
(ii) In the case of a minor, 3 years tional.
after the patient becomes of age under (6) At least two persons are on duty
State law or 5 years after the date of on the premises of the organization
discharge, whichever is longer. whenever a patient is being treated.
(e) Standard: Indexes. Clinical records (7) No occupancies or activities unde-
are indexed at least according to name sirable or injurious to the health and
of patient to facilitate acquisition of safety of patients are located in the
statistical medical information and re- building.
226
(b) Standard: Maintenance of equip- (b) All personnel follow written pro-
ment, building, and grounds. The organi- cedures for effective aseptic tech-
zation establishes a written preventive- niques. The procedures are reviewed
maintenance program to ensure that— annually and revised if necessary to
(1) The equipment is operative, and is improve them.
properly calibrated; and (c) Standard: Housekeeping. (1) The or-
(2) The interior and exterior of the ganization employs sufficient house-
building are clean and orderly and keeping personnel and provides all nec-
maintained free of any defects that are essary equipment to maintain a safe,
a potential hazard to patients, per- clean, and orderly interior. A full-time
sonnel, and the public. employee is designated as the one re-
(c) Standard: Other environmental con- sponsible for the housekeeping services
siderations. The organization provides a and for supervision and training of
functional, sanitary, and comfortable housekeeping personnel.
environment for patients, personnel, (2) An organization that has a con-
and the public. tract with an outside resource for
(1) Provision is made for adequate housekeeping services may be found to
and comfortable lighting levels in all be in compliance with this standard
areas; limitation of sounds at comfort provided the organization or outside
levels; a comfortable room tempera- resource or both meet the require-
ture; and adequate ventilation through ments of the standard.
windows, mechanical means, or a com- (d) Standard: Linen. The organization
bination of both. has available at all times a quantity of
(2) Toilet rooms, toilet stalls, and linen essential for proper care and
lavatories are accessible and con- comfort of patients. Linens are han-
structed so as to allow use by non- dled, stored, processed, and transported
ambulatory and semiambulatory indi- in such a manner as to prevent the
viduals. spread of infection.
(3) Whatever the size of the building, (e) Standard: Pest control. The organi-
there is an adequate amount of space zation’s premises are maintained free
for the services provided and disabil- from insects and rodents through oper-
ities treated, including reception area, ation of a pest-control program.
staff space, examining room, treatment
areas, and storage. FR 52826, Sept. 30, 1977. Further redesignated
[41 FR 20865, May 21, 1976. Redesignated at 42 and amended at 60 FR 2326, 2328, Jan. 9, 1995;
FR 52826, Sept. 30, 1977. Further redesignated 60 FR 50447, Sept. 29, 1995]
and amended at 60 FR 2326, Jan. 9, 1995]
§ 485.725 Condition of participation: Emergency preparedness.
Infection control. The Clinics, Rehabilitation Agencies,
The organization that provides out- and Public Health Agencies as Pro-
patient physical therapy services es- viders of Outpatient Physical Therapy
tablishes an infection-control com- and Speech-Language Pathology Serv-
mittee of representative professional ices (‘‘Organizations’’) must comply
staff with responsibility for overall in- with all applicable Federal, State, and
fection control. All necessary house- local emergency preparedness require-
keeping and maintenance services are ments. The Organizations must estab-
provided to maintain a sanitary and lish and maintain an emergency pre-
comfortable environment and to help paredness program that meets the re-
prevent the development and trans- quirements of this section. The emer-
mission of infection. gency preparedness program must in-
(a) Standard: Infection-control com- clude, but not be limited to, the fol-
mittee. The infection-control com- lowing elements:
mittee establishes policies and proce- (a) Emergency plan. The Organiza-
dures for investigating, controlling, tions must develop and maintain an
and preventing infections in the orga- emergency preparedness plan that
nization and monitors staff perform- must be reviewed and updated at least
ance to ensure that the policies and annually. The plan must do all of the
procedures are executed. following:
227
§ 485.727 42 CFR Ch. IV (10–1–17 Edition)
(1) Be based on and include a docu- emergency preparedness communica-

mented, facility-based and community- tion plan that complies with Federal,
based risk assessment, utilizing an all- State, and local laws and must be re-
hazards approach. viewed and updated at least annually.
(2) Include strategies for addressing The communication plan must include
emergency events identified by the all of the following:
risk assessment. (1) Names and contact information
(3) Address patient population, infor the following:
cluding, but not limited to, the type of (i) Staff.
services the Organizations have the (ii) Entities providing services under
ability to provide in an emergency; and arrangement.
continuity of operations, including del- (iii) Patients’ physicians.
egations of authority and succession (iv) Other Organizations.
plans. (v) Volunteers.
(4) Address the location and use of (2) Contact information for the fol-
alarm systems and signals; and meth- lowing:
ods of containing fire.
(i) Federal, state, tribal, regional and
(5) Include a process for cooperation
local emergency preparedness staff.
and collaboration with local, tribal, re-
(ii) Other sources of assistance.
gional, State, and Federal emergency
preparedness officials’ efforts to main- (3) Primary and alternate means for
tain an integrated response during a communicating with the following:
disaster or emergency situation. (i) Organizations’ staff.
(6) Be developed and maintained with (ii) Federal, state, tribal, regional,
assistance from fire, safety, and other and local emergency management
appropriate experts. agencies.
(b) Policies and procedures. The Orga- (4) A method for sharing information
nizations must develop and implement and medical documentation for pa-
emergency preparedness policies and tients under the Organizations’ care, as
procedures, based on the emergency necessary, with other health care pro-
plan set forth in paragraph (a) of this viders to maintain the continuity of
section, risk assessment at paragraph care.
(a)(1) of this section, and the commu- (5) A means of providing information
nication plan at paragraph (c) of this about the Organizations’ needs, and
section. The policies and procedures their ability to provide assistance, to
must be reviewed and updated at least the authority having jurisdiction or
annually. At a minimum, the policies the Incident Command Center, or des-
and procedures must address the fol- ignee.
lowing: (d) Training and testing. The Organi-
(1) Safe evacuation from the Organi- zations must develop and maintain an
zations, which includes staff respon- emergency preparedness training and
sibilities, and needs of the patients. testing program that is based on the
(2) A means to shelter in place for pa- emergency plan set forth in paragraph
tients, staff, and volunteers who re- (a) of this section, risk assessment at
main in the facility. paragraph (a)(1) of this section, policies
(3) A system of medical documenta- and procedures at paragraph (b) of this
tion that preserves patient informa- section, and the communication plan
tion, protects confidentiality of patient at paragraph (c) of this section. The
information, and secures and main- training and testing program must be
tains the availability of records. reviewed and updated at least annu-
(4) The use of volunteers in an emer- ally.
gency or other emergency staffing (1) Training program. The Organiza-
strategies, including the process and tions must do all of the following:
role for integration of State and Feder- (i) Initial training in emergency pre-
ally designated health care profes- paredness policies and procedures to all
sionals to address surge needs during new and existing staff, individuals pro-
an emergency. viding services under arrangement, and

(c) Communication plan. The Organi- volunteers, consistent with their ex-
zations must develop and maintain an pected roles.
228
(ii) Provide emergency preparedness separately certified facility’s unique

training at least annually. circumstances, patient populations,
(iii) Maintain documentation of the and services offered.
training. (3) Demonstrate that each separately
(iv) Demonstrate staff knowledge of certified facility is capable of actively
emergency procedures. using the unified and integrated emer-
(2) Testing. The Organizations must gency preparedness program and is in
conduct exercises to test the emer- compliance.
gency plan at least annually. The Orga- (4) Include a unified and integrated
nizations must do the following: emergency plan that meets the require-
(i) Participate in a full-scale exercise ments of paragraphs (a)(2), (3), and (4)
that is community-based or when a of this section. The unified and inte-
community-based exercise is not acces- grated emergency plan must also be
sible, an individual, facility-based. If based on and include all of the fol-
the Organizations experience an actual lowing:
natural or man-made emergency that (i) A documented community-based
requires activation of the emergency risk assessment, utilizing an all-haz-
plan, the organization is exempt from ards approach.
engaging in a community-based or in- (ii) A documented individual facility-
dividual, facility-based full-scale exer- based risk assessment for each sepa-
cise for 1 year following the onset of rately certified facility within the
the actual event. health system, utilizing an all-hazards
(ii) Conduct an additional exercise approach.
that may include, but is not limited to (5) Include integrated policies and
the following: procedures that meet the requirements
(A) A second full-scale exercise that set forth in paragraph (b) of this sec-
is community-based or individual, fa- tion, a coordinated communication
cility-based. plan and training and testing programs
(B) A tabletop exercise that includes that meet the requirements of para-
a group discussion led by a facilitator, graphs (c) and (d) of this section, re-
using a narrated, clinically-relevant spectively.
lem statements, directed messages, or [81 FR 64037, Sept. 16, 2016]
prepared questions designed to chal-
lenge an emergency plan. § 485.729 Condition of participation:
Program evaluation.
(iii) Analyze the Organization’s re-
sponse to and maintain documentation The organization has procedures that
of all drills, tabletop exercises, and provide for a systematic evaluation of
emergency events, and revise their its total program to ensure appropriate
emergency plan, as needed. utilization of services and to determine
(e) Integrated healthcare systems. If the whether the organization’s policies are
Organizations are part of a healthcare followed in providing services to pa-
system consisting of multiple sepa- tients through employees or under ar-
rately certified healthcare facilities rangements with others.
that elects to have a unified and inte- (a) Standard: Clinical-record review. A
grated emergency preparedness pro- sample of active and closed clinical
gram, the Organizations may choose to records is reviewed quarterly by the
participate in the healthcare system’s appropriate health professionals to en-
coordinated emergency preparedness sure that established policies are fol-
program. If elected, the unified and in- lowed in providing services.
tegrated emergency preparedness pro- (b) Standard: Annual statistical evalua-
gram must do all of the following: tion. An evaluation is conducted annu-
(1) Demonstrate that each separately ally of statistical data such as number
certified facility within the system ac- of different patients treated, number of
tively participated in the development patient visits, condition on admission
of the unified and integrated emer- and discharge, number of new patients,
gency preparedness program. number of patients by diagnosis(es),

(2) Be developed and maintained in a sources of referral, number and cost of
manner that takes into account each units of service by treatment given,
229
§ 485.900 42 CFR Ch. IV (10–1–17 Edition)
and total staff days or work hours by Active treatment plan means an indi-
discipline. vidualized client plan that focuses on
the provision of care and treatment
FR 52826, Sept. 30, 1977. Further redesignated
services that address the client’s phys-
and amended at 60 FR 2326, 2329, Jan. 9, 1995] ical, psychological, psychosocial, emo-
tional, and therapeutic needs and goals
as identified in the comprehensive as-
Subpart I [Reserved] sessment.
Community mental health center
Subpart J—Conditions of Partici- (CMHC) means an entity as defined in
pation: Community Mental § 410.2 of this chapter.
Health Centers (CMHCs) Comprehensive assessment means a
thorough evaluation of the client’s
SOURCE: 78 FR 64630, Oct. 29, 2013, unless physical, psychological, psychosocial,
otherwise noted. emotional, and therapeutic needs re-
lated to the diagnosis under which care
§ 485.900 Basis and scope. is being furnished by the CMHC.
Employee of a CMHC means an indi-
(a) Basis. This subpart is based on the
vidual—
following sections of the Social Secu-
(1) Who works for the CMHC and for
rity Act:
whom the CMHC is required to issue a
(1) Section 1832(a)(2)(J) of the Act W–2 form on his or her behalf; or
specifies that payments may be made (2) For whom an agency or organiza-
under Medicare Part B for partial hos- tion issues a W–2 form, and who is as-
pitalization services furnished by a signed to such CMHC if the CMHC is a
community mental health center subdivision of an agency or organiza-
(CMHC) as described in section tion.
1861(ff)(3)(B) of the Act. Initial evaluation means an immediate
(2) Section 1861(ff) of the Act de- care and support assessment of the cli-
scribes the items and services that are ent’s physical, psychosocial (including
covered under Medicare Part B as a screen for harm to self or others), and
‘‘partial hospitalization services’’ and therapeutic needs related to the psy-
the conditions under which the items chiatric illness and related conditions
and services must be provided. In addi- for which care is being furnished by the
tion, section 1861(ff) of the Act specifies CMHC.
that the entities authorized to provide Representative means an individual
partial hospitalization services under who has the authority under State law
Medicare Part B include CMHCs and to authorize or terminate medical care
defines that term. on behalf of a client who is mentally or
(3) Section 1866(e)(2) of the Act speci- physically incapacitated. This includes
fies that a provider of services for pur- a legal guardian.
poses of provider agreement require- Restraint means—
ments includes a CMHC as defined in (1) Any manual method, physical or
section 1861(ff)(3)(B) of the Act, but mechanical device, material, or equip-
only with respect to providing partial ment that immobilizes or reduces the
hospitalization services. ability of a client to move his or her
(b) Scope. The provisions of this sub- arms, legs, body, or head freely, not in-
part serve as the basis of survey activi- cluding devices, such as orthopedically
ties for the purpose of determining prescribed devices, surgical dressings
whether a CMHC meets the specified or bandages, protective helmets, or
requirements that are considered nec- other methods that involve the phys-
essary to ensure the health and safety ical holding of a client for the purpose
of clients; and for the purpose of deter- of conducting routine physical exami-
mining whether a CMHC qualifies for a nations or tests, or to protect the cli-
provider agreement under Medicare. ent from falling out of bed, or to per-
mit the client to participate in activi-
§ 485.902 Definitions. ties without the risk of physical harm

As used in this subpart, unless the (this does not include a client being
context indicates otherwise— physically escorted); or
230
(2) A drug or medication when it is (ii) Has 1 year of social work experi-
used as a restriction to manage the cli- ence in a psychiatric healthcare set-
ent’s behavior or restrict the client’s ting.
freedom of movement, and which is not (5) Mental health counselor. A profes-
a standard treatment or dosage for the sional counselor who is certified and/or
client’s condition. licensed by the State in which he or
Seclusion means the involuntary con- she practices, and has the skills and
finement of a client alone in a room or knowledge to provide a range of behav-
an area from which the client is phys- ioral health services to clients. The
ically prevented from leaving. mental health counselor conducts as-
sessments and provides services in
Volunteer means an individual who is
areas such as psychotherapy, substance
an unpaid worker of the CMHC; or if
abuse, crisis management,
the CMHC is a subdivision of an agency
psychoeducation, and prevention pro-
or organization, is an unpaid worker of
grams.
the agency or organization and is as- (6) Occupational therapist. A person
signed to the CMHC. All volunteers who meets the requirements for the
must meet the standard training redefinition of ‘‘occupational therapist’’
quirements under § 485.918(d). at § 484.4 of this chapter.
(7) Physician. An individual who
Personnel qualifications. meets the qualifications and conditions
as defined in section 1861(r) of the Act,
(a) Standard: General qualification re- and provides the services at § 410.20 of
quirements. All professionals who fur- this chapter, and has experience pro-
nish services directly, under an indi- viding mental health services to cli-
vidual contract, or under arrangements ents.
with a CMHC, must be legally author- (8) Physician assistant. An individual
ized (licensed, certified or registered) who meets the qualifications and con-
in accordance with applicable Federal, ditions as defined in section
State and local laws, and must act only 1861(s)(2)(K)(i) of the Act and provides
within the scope of their State li- the services, in accordance with State
censes, certifications, or registrations. law, at § 410.74 of this chapter.
All personnel qualifications must be (9) Advanced practice nurse. An indi-
kept current at all times. vidual who meets the following quali-
(b) Standard: Personnel qualifications fications:
for certain disciplines. The following (i) Is a nurse practitioner who meets
qualifications must be met: the qualifications at § 410.75 of this
(1) Administrator of a CMHC. A CMHC chapter; or
employee who meets the education and (ii) Is a clinical nurse specialist who
experience requirements established by meets the qualifications at § 410.76 of
the CMHC’s governing body for that this chapter.
position and who is responsible for the (10) Psychiatric registered nurse. A reg-
day-to-day operation of the CMHC. istered nurse, who is a graduate of an
approved school of professional nurs-
(2) Clinical psychologist. An individual
ing, is licensed as a registered nurse by
who meets the qualifications at
the State in which he or she is prac-
§ 410.71(d) of this chapter.
ticing, and has at least 1 year of edu-
(3) Clinical Social worker. An indication and/or training in psychiatric
vidual who meets the qualifications at nursing.
§ 410.73 of this chapter. (11) Psychiatrist. An individual who
(4) Social worker. An individual who— specializes in assessing and treating
(i) Has a baccalaureate degree in so- persons having psychiatric disorders; is
cial work from an institution accred- board certified, or is eligible to be
ited by the Council on Social Work board certified by the American Board
Education, or a baccalaureate degree in of Psychiatry and Neurology, or has
psychology or sociology, and is super- documented equivalent education,
vised by a clinical social worker, as de- training or experience, and is fully li-
scribed in paragraph (b)(3) of this sec- censed to practice medicine in the
tion; and State in which he or she practices.
231
§ 485.910 42 CFR Ch. IV (10–1–17 Edition)
§ 485.910 Condition of participation: (2) Refuse care or treatment.

Client rights. (3) Have a confidential clinical
The client has the right to be in- record. Access to or release of client in-
formed of his or her rights. The CMHC formation and the clinical record cli-
must protect and promote the exercise ent information is permitted only in
of these client rights. accordance with 45 CFR parts 160 and
(a) Standard: Notice of rights and re- 164.
sponsibilities. (1) During the initial eval- (4) Be free from mistreatment, ne-
uation, the CMHC must provide the cli- glect, or verbal, mental, sexual, and
ent, the client’s representative (if ap- physical abuse, including injuries of
propriate) or surrogate with verbal and unknown source, and misappropriation
written notice of the client’s rights and of client property.
responsibilities. The verbal notice (5) Receive information about spe-
must be in a language and manner that cific limitations on services that he or
the client or client’s representative or she will be furnished.
surrogate understands. Written notice (6) Not be compelled to perform serv-
must be understandable to persons who ices for the CMHC, and to be com-
have limited English proficiency. pensated by the CMHC for any work
(2) During the initial evaluation, the performed for the CMHC at prevailing
CMHC must inform and distribute writ- wages and commensurate with the cli-
ten information to the client con- ent’s abilities.
cerning its policies on filing a griev- (d) Standard: Addressing violations of
ance. client rights. The CMHC must adhere to
(3) The CMHC must obtain the cli-
the following requirements:
ent’s and/or the client representative’s
(1) Ensure that all alleged violations
signature confirming that he or she has
involving mistreatment, neglect, or
received a copy of the notice of rights
verbal, mental, sexual, and physical
and responsibilities.
(b) Standard: Exercise of rights and re- abuse, including injuries of unknown
spect for property and person. (1) The cli- source, and misappropriation of client
ent has the right to— property by anyone, including those
(i) Exercise his or her rights as a cli- furnishing services on behalf of the
ent of the CMHC. CMHC, are reported immediately to
(ii) Have his or her property and per- the CMHC’s administrator by CMHC
son treated with respect. employees, volunteers and contracted
(iii) Voice grievances and understand staff.
the CMHC grievance process; including (2) Immediately investigate all al-
but not limited to grievances regarding leged violations involving anyone fur-
mistreatment and treatment or care nishing services on behalf of the CMHC
that is (or fails to be) furnished. and immediately take action to pre-
(iv) Not be subjected to discrimina- vent further potential violations while
tion or reprisal for exercising his or her the alleged violation is being verified.
rights. Investigations and documentation of
(2) If a client has been adjudged in- all alleged violations must be con-
competent under State law by a court ducted in accordance with procedures
of proper jurisdiction, the rights of the established by the CMHC.
client are exercised by the person ap- (3) Take appropriate corrective ac-
pointed in accordance with State law tion in accordance with State law if
to act on the client’s behalf. the alleged violation is investigated by
(3) If a State court has not adjudged the CMHC’s administration or verified
a client incompetent, any legal rep- by an outside entity having jurisdic-
resentative designated by the client in tion, such as the State survey and cer-
accordance with State law may exer- tification agency or the local law en-
cise the client’s rights to the extent al- forcement agency; and
lowed under State law. (4) Ensure that, within 5 working
(c) Standard: Rights of the client. The days of becoming aware of the viola-
client has a right to— tion, all violations are reported to the
(1) Be involved in developing his or State survey and certification agency,
her active treatment plan. and verified violations are reported to
232
State and local entities having juris- the client’s clinical record of the fol-
diction. lowing:
(e) Standard: Restraint and seclusion. (A) A description of the client’s be-
(1) All clients have the right to be free havior and the intervention used.
from physical or mental abuse, and (B) Alternatives or other less restric-
corporal punishment. All clients have tive interventions attempted (as appli-
the right to be free from restraint or cable).
seclusion, of any form, imposed as a (C) The client’s condition or symp-
means of coercion, discipline, conven- tom(s) that warranted the use of the
ience, or retaliation by staff. Restraint restraint or seclusion.
or seclusion, defined in § 485.902, may (D) The client’s response to the inter-
only be imposed to ensure the imme- vention(s) used, including the rationale
diate physical safety of the client, for continued use of the intervention.
staff, or other individuals. (E) The name of the hospital to
(2) The use of restraint or seclusion which the client was transferred.
must be in accordance with the written (f) Standard: Restraint or seclusion:
order of a physician or other licensed Staff training requirements. The client
independent practitioner who is au- has the right to safe implementation of
thorized to order restraint or seclusion restraint or seclusion by trained staff.
in accordance with State law and must Application of restraint or seclusion in
not exceed one 1-hour duration per a CMHC must only be imposed when a
order. client becomes an immediate physical
(3) The CMHC must obtain a cor- threat to himself or herself, staff or
responding order for the client’s imme- other individuals and only in facilities
diate transfer to a hospital when re- where restraint and seclusion are per-
straint or seclusion is ordered. mitted.
(4) Orders for the use of restraint or (1) Training intervals. In facilities
seclusion must never be written as a where restraint and seclusion are per-
standing order or on an as-needed mitted, all appropriate client care staff
basis. working in the CMHC must be trained
(5) When a client becomes an imme- and able to demonstrate competency in
diate threat to the physical safety of the application of restraints, imple-
himself or herself, staff or other indi- mentation of seclusion, monitoring, as-
viduals, the CMHC must adhere to the sessment, and providing care for a cli-
following requirements: ent in restraint or seclusion and use of
(i) Restraint or seclusion may only alternative methods to restraint and
be used when less restrictive interven- seclusion. In facilities where restraint
tions have been determined to be inef- and seclusion are not permitted, appro-
fective to protect the client or other priate client care staff working in
individuals from harm. CMHC must be trained in the use of al-
(ii) The type or technique of restraint ternative methods to restraint and se-
or seclusion used must be the least re- clusion. Training will occur as follows:
strictive intervention that will be ef- (i) Before performing any of the ac-
fective to protect the client or other tions specified in this paragraph (f).
individuals from harm. (ii) As part of orientation.
(iii) The use of restraint or seclusion (iii) Subsequently on a periodic basis,
must be implemented in accordance consistent with the CMHC’s policy.
with safe and appropriate restraint and (2) Training content. The CMHC must
seclusion techniques as determined by require all appropriate staff caring for
State law. clients to have appropriate education,
(iv) The condition of the client who is training, and demonstrated knowledge
restrained or secluded must be continu- based on the specific needs of the client
ously monitored by a physician or by population in at least the following:
trained staff who have completed the (i) Techniques to identify staff and
training criteria specified in paragraph client behaviors, events, and environ-
(f) of this section. mental factors that may trigger cir-

(v) When restraint or seclusion is cumstances that could require the use
used, there must be documentation in of restraint or seclusion.
233
§ 485.914 42 CFR Ch. IV (10–1–17 Edition)
(ii) The use of nonphysical interven- § 485.914 Condition of participation:

tion skills. Admission, initial evaluation, com-
(iii) In facilities where restraint and prehensive assessment, and dis-
seclusion are permitted, choosing the charge or transfer of the client.
least restrictive intervention based on The CMHC must ensure that all cli-
an individualized assessment of the clients admitted into its program are ap-
ent’s medical and behavioral status or propriate for the services the CMHC
condition. furnishes in its facility.
(iv) The safe application and use of (a) Standard: Admission. (1) The CMHC
all types of restraint or seclusion that must determine that each client is ap-
propriate for the services it provides as
are permitted in the CMHC, including
specified in § 410.2 of this chapter.
training in how to recognize and re-
(2) For clients assessed and admitted
spond to signs of physical and psycho-
to receive partial hospitalization serv-
logical distress. ices, the CMHC must also meet sepa-
(v) In facilities where restraint and rate requirements as specified in
seclusion are permitted, clinical identi- § 485.918(f).
fication of specific behavioral changes (b) Standard: Initial evaluation. (1) A
that indicate that restraint or seclu- licensed mental health professional
sion is no longer necessary. employed by the CMHC and acting
(vi) In facilities where restraint and within his or her state scope of prac-
seclusion are permitted, monitoring tice requirements must complete the
the physical and psychological well- initial evaluation within 24 hours of
being of the client who is restrained or the client’s admission to the CMHC.
secluded, including, but not limited to, (2) The initial evaluation, at a min-
respiratory and circulatory status, imum, must include the following:
skin integrity, vital signs, and any spe- (i) The admitting diagnosis as well as
cial requirements specified by the other diagnoses.
CMHC’s policy. (ii) The source of referral.
(iii) The reason for admission as stat-
(3) Trainer requirements. Individuals
ed by the client or other individuals
providing staff training must be quali-
who are significantly involved.
fied as evidenced by education, train-
(iv) Identification of the client’s im-
ing, and experience in techniques used mediate clinical care needs related to
to address clients’ behaviors. the psychiatric diagnosis.
(4) Training documentation. The CMHC (v) A list of current prescriptions and
must document in the staff personnel over-the-counter medications, as well
records that the training and dem- as other substances that the client
onstration of competency were success- may be taking.
fully completed. (vi) For partial hospitalization serv-
(g) Standard: Death reporting require- ices only, include an explanation as to
ments. The CMHC must report deaths why the client would be at risk for hos-
associated with the use of seclusion or pitalization if the partial hospitaliza-
restraint. tion services were not provided.
(1) The CMHC must report to CMS (3) Based on the findings of the ini-
each death that occurs while a client is tial evaluation, the CMHC must deter-
in restraint or seclusion awaiting mine the appropriate members of each
transfer to a hospital. client’s interdisciplinary treatment
team.
(2) Each death referenced in para-
(c) Standard: Comprehensive assess-
graph (g)(1) of this section must be re-
ment. (1) The comprehensive assess-
ported to the CMS Regional Office by
ment must be completed by licensed
telephone no later than the close of mental health professionals who are
business the next business day fol- members of the interdisciplinary treat-
lowing knowledge of the client’s death. ment team, performing within their
(3) Staff must document in the cli- State’s scope of practice.
ent’s clinical record the date and time (2) The comprehensive assessment
the death was reported to CMS. must be completed in a timely manner,
consistent with the client’s immediate
234
needs, but no later than 4 working days primary health care provider (if any),
after admission to the CMHC. when warranted.
(3) The comprehensive assessment (xii) Factors to be considered in dis-
must identify the physical, psycho- charge planning.
logical, psychosocial, emotional, thera- (xiii) Identification of the client’s
peutic, and other needs related to the current social and health care support
client’s psychiatric illness. The systems.
CMHC’s interdisciplinary treatment (xiv) For pediatric clients, the CMHC
team must ensure that the active must assess the social service needs of
treatment plan is consistent with the the client, and make referrals to social
findings of the comprehensive assess- services and child welfare agencies as
ment. appropriate.
(4) The comprehensive assessment, at (d) Standard: Update of the comprehen-
a minimum, must include the fol- sive assessment. (1) The CMHC must up-
lowing: date the comprehensive assessment via
(i) The reasons for the admission. the CMHC interdisciplinary treatment
(ii) A psychiatric evaluation, com- team, in consultation with the client’s
pleted by a psychiatrist, non-physician primary health care provider (if any),
practitioner or psychologist practicing when changes in the client’s status, re-
within the scope of State licensure sponses to treatment, or goal achieve-
that includes the medical history and ment have occurred.
severity of symptoms. Information (2) The assessment must be updated
may be gathered from the client’s pri- no less frequently than every 30 days.
mary health care provider (if any), con- (3) The update must include informa-
tingent upon the client’s consent. tion on the client’s progress toward de-
(iii) Information concerning previous sired outcomes, a reassessment of the
and current mental status, including client’s response to care and therapies,
but not limited to, previous thera- and the client’s goals.
peutic interventions and hospitaliza- (e) Standard: Discharge or transfer of
tions. the client. (1) If the client is transferred
(iv) Information regarding the onset to another entity, the CMHC must,
of symptoms of the illness and cir- within 2 working days, forward to the
cumstances leading to the admission. entity, a copy of—
(v) A description of attitudes and be-
(i) The CMHC discharge summary.
haviors, including cultural and envi-
(ii) The client’s clinical record, if re-
ronmental factors that may affect the
quested.
client’s treatment plan.
(vi) An assessment of intellectual (2) If a client refuses the services of a
functioning, memory functioning, and CMHC, or is discharged from a CMHC
orientation. due to noncompliance with the treat-
(vii) Complications and risk factors ment plan, the CMHC must forward to
that may affect the care planning. the primary health care provider (if
(viii) Functional status, including any) a copy of—
the client’s ability to understand and (i) The CMHC discharge summary.
participate in his or her own care, and (ii) The client’s clinical record, if re-
the client’s strengths and goals. quested.
(ix) Factors affecting client safety or (3) The CMHC discharge summary
the safety of others, including behav- must include—
ioral and physical factors, as well as (i) A summary of the services pro-
suicide risk factors. vided, including the client’s symptoms,
(x) A drug profile that includes a re- treatment and recovery goals and pref-
view of all of the client’s prescription erences, treatments, and therapies.
and over-the-counter medications; (ii) The client’s current active treat-
herbal remedies; and other alternative ment plan at time of discharge.
treatments or substances that could af- (iii) The client’s most recent physi-
fect drug therapy. cian orders.
(xi) The need for referrals and further (iv) Any other documentation that
evaluation by appropriate health care will assist in post-discharge continuity
professionals, including the client’s of care.
235
§ 485.916 42 CFR Ch. IV (10–1–17 Edition)
(4) The CMHC must adhere to all Fed- active treatment plan that is estab-
eral and State-related requirements lished by the CMHC interdisciplinary
pertaining to the medical privacy and treatment team, the client, and the cli-
the release of client information. ent’s primary caregiver(s), in accord-
ance with the client’s recovery goals
§ 485.916 Condition of participation: and preferences, within 7 working days
Treatment team, person-centered of admission to the CMHC. The CMHC
active treatment plan, and coordi-
nation of services. must ensure that each client and the
client’s primary caregiver(s), as appli-
The CMHC must designate an inter- cable, receive education and training
disciplinary treatment team that is re- provided by the CMHC that are con-
sponsible, with the client, for direct- sistent with the client’s and caregiver’s
ing, coordinating, and managing the responsibilities as identified in the ac-
care and services furnished for each cli- tive treatment plan.
ent. The interdisciplinary treatment (c) Standard: Content of the person-
team is composed of individuals who centered active treatment plan. The
work together to meet the physical, CMHC must develop a person-centered
medical, psychosocial, emotional, and individualized active treatment plan
therapeutic needs of CMHC clients. for each client. The active treatment
(a) Standard: Delivery of services. (1)
plan must take into consideration cli-
An interdisciplinary treatment team,
ent recovery goals and the issues iden-
led by a physician, NP, PA, CNS, clin-
tified in the comprehensive assess-
ical psychologist, or clinical social
ment. The active treatment plan must
worker, must provide the care and
include all services necessary to assist
services offered by the CMHC.
the client in meeting his or her recov-
(2) Based on the findings of the com-
ery goals, including the following:
prehensive assessment, the CMHC must
(1) Client diagnoses.
determine the appropriate licensed
mental health professional, who is a (2) Treatment goals.
member of the client’s interdiscipli- (3) Interventions.
nary treatment team, to coordinate (4) A detailed statement of the type,
care and treatment decisions with each duration, and frequency of services, in-
client, to ensure that each client’s cluding social work, psychiatric nurs-
needs are assessed, and to ensure that ing, counseling, and therapy services,
the active treatment plan is imple- necessary to meet the client’s specific
mented as indicated. needs.
(3) The interdisciplinary treatment (5) Drugs, treatments, and individual
team may include: and/or group therapies.
(i) A doctor of medicine, osteopathy (6) Family psychotherapy with the
or psychiatry (who is an employee of or primary focus on treatment of the cli-
under contract with the CMHC). ent’s conditions.
(ii) A psychiatric registered nurse. (7) The interdisciplinary treatment
(iii) A clinical social worker. team’s documentation of the client’s or
(iv) A clinical psychologist. representative’s and primary care-
(v) An occupational therapist. giver’s (if any) understanding, involve-
(vi) Other licensed mental health ment, and agreement with the plan of
professionals, as necessary. care, in accordance with the CMHC’s
(vii) Other CMHC staff or volunteers, policies.
as necessary. (d) Standard: Review of the person-cen-
(4) If the CMHC has more than one tered active treatment plan. The CMHC
interdisciplinary team, it must des- interdisciplinary treatment team must
ignate the treatment team responsible review, revise, and document the indi-
for establishing policies and procedures vidualized active treatment plan as fre-
governing the coordination of services quently as the client’s condition re-
and the day-to-day provision of CMHC quires, but no less frequently than
care and services. every 30 calendar days. A revised active
(b) Standard: Person-centered active treatment plan must include informa-
treatment plan. All CMHC care and serv- tion from the client’s initial evalua-
ices furnished to clients must be con- tion and comprehensive assessments,
sistent with an individualized, written, the client’s progress toward outcomes
236
and goals specified in the active treat- in CMHC performance. The CMHC must
ment plan, and changes in the client’s maintain documentary evidence of its
goals. The CMHC must also meet par- quality assessment and performance
tial hospitalization program require- improvement program and be able to
ments specified under § 424.24(e) of this demonstrate its operation to CMS.
chapter if such services are included in (a) Standard: Program scope. (1) The
the active treatment plan. CMHC program must be able to dem-
(e) Standard: Coordination of services. onstrate measurable improvement in
The CMHC must develop and maintain indicators related to improving behav-
a system of communication that ioral health outcomes and CMHC serv-
assures the integration of services in ices.
accordance with its policies and proce- (2) The CMHC must measure, ana-
dures and, at a minimum, would do the lyze, and track quality indicators; ad-
following: verse client events, including the use of
(1) Ensure that the interdisciplinary restraint and seclusion; and other as-
treatment team maintains responsi- pects of performance that enable the
bility for directing, coordinating, and CMHC to assess processes of care,
supervising the care and services pro- CMHC services, and operations.
vided. (b) Standard: Program data. (1) The
(2) Ensure that care and services are program must use quality indicator
provided in accordance with the active data, including client care, and other
treatment plan. relevant data, in the design of its pro-
(3) Ensure that the care and services gram.
provided are based on all assessments (2) The CMHC must use the data col-
of the client. lected to do the following:
(4) Provide for and ensure the ongo- (i) Monitor the effectiveness and
ing sharing of information among all safety of services and quality of care.
disciplines providing care and services, (ii) Identify opportunities and prior-
whether the care and services are pro- ities for improvement.
vided by employees or those under con- (3) The frequency and detail of the
tract with the CMHC. data collection must be approved by
(5) Provide for ongoing sharing of in- the CMHC’s governing body.
formation with other health care and (c) Standard: Program activities. (1)
non-medical providers, including the The CMHC’s performance improvement
primary health care provider, fur- activities must:
nishing services to a client for condi- (i) Focus on high risk, high volume,
tions unrelated to the psychiatric con- or problem-prone areas.
dition for which the client has been ad- (ii) Consider incidence, prevalence,
mitted, and non-medical supports ad- and severity of problems.
dressing environmental factors such as (iii) Give priority to improvements
housing and employment. that affect behavioral outcomes, client
safety, and person-centered quality of
§ 485.917 Condition of participation: care.
Quality assessment and perform- (2) Performance improvement activi-
ance improvement. ties must track adverse client events,
The CMHC must develop, implement, analyze their causes, and implement
and maintain an effective, ongoing, preventive actions and mechanisms
CMHC-wide data-driven quality assess- that include feedback and learning
ment and performance improvement throughout the CMHC.
program (QAPI). The CMHC’s gov- (3) The CMHC must take actions
erning body must ensure that the pro- aimed at performance improvement
gram reflects the complexity of its or- and, after implementing those actions,
ganization and services, involves all the CMHC must measure its success
CMHC services (including those serv- and track performance to ensure that
ices furnished under contract or ar- improvements are sustained.
rangement), focuses on indicators re- (d) Standard: Performance improvement
lated to improved behavioral health or projects. CMHCs must develop, imple-

other healthcare outcomes, and takes ment and evaluate performance im-
actions to demonstrate improvement provement projects.
237
§ 485.918 42 CFR Ch. IV (10–1–17 Edition)
(1) The number and scope of distinct to the governing body and is respon-
performance improvement projects sible for the day-to-day operation of
conducted annually, based on the needs the CMHC. The administrator must be
of the CMHC’s population and internal a CMHC employee and meet the edu-
organizational needs, must reflect the cation and experience requirements es-
scope, complexity, and past perform- tablished by the CMHC’s governing
ance of the CMHC’s services and oper- body.
ations. (b) Standard: Provision of services. (1)
(2) The CMHC must document what A CMHC must be primarily engaged in
performance improvement projects are providing the following care and serv-
being conducted, the reasons for con- ices to all clients served by the CMHC
ducting these projects, and the measur- regardless of payer type, and must do
able progress achieved on these so in a manner that is consistent with
projects. the following accepted standards of
(e) Standard: Executive responsibilities. practice:
The CMHC’s governing body is respon- (i) Provides outpatient services, in-
sible for ensuring the following: cluding specialized outpatient services
(1) That an ongoing QAPI program for children, elderly individuals, indi-
for quality improvement and client viduals with serious mental illness, and
safety is defined, implemented, main- residents of its mental health service
tained, and evaluated annually. area who have been discharged from in-
(2) That the CMHC-wide quality as- patient mental health facilities.
sessment and performance improve- (ii) Provides 24-hour-a-day emer-
ment efforts address priorities for im- gency care services.
proved quality of care and client safe- (iii) Provides day treatment, partial
ty, and that all improvement actions hospitalization services other than in
are evaluated for effectiveness. an individual’s home or in an inpatient
(3) That one or more individual(s) or residential setting, or psychosocial
who are responsible for operating the rehabilitation services.
QAPI program are designated. (iv) Provides screening for clients
being considered for admission to State
§ 485.918 Condition of participation: mental health facilities to determine
Organization, governance, adminis- the appropriateness of such services,
tration of services, and partial hos- unless otherwise directed by State law.
pitalization services. (v) Provides at least 40 percent of its
The CMHC must organize, manage, items and services to individuals who
and administer its resources to provide are not eligible for benefits under title
CMHC services, including specialized XVIII of the Act, as measured by the
services for children, elderly individ- total number of CMHC clients treated
uals, individuals with serious mental by the CMHC for whom services are not
illness, and residents of its mental paid for by Medicare, divided by the
health service area who have been dis- total number of clients treated by the
charged from an inpatient mental CMHC for each 12-month period of en-
health facility. rollment.
(a) Standard: Governing body and ad- (A) A CMHC is required to submit to
ministrator. (1) A CMHC must have a CMS a certification statement pro-
designated governing body made up of vided by an independent entity that
two or more designated persons, one of certifies that the CMHC’s client popu-
which may be the administrator, that lation meets the 40 percent require-
assumes full legal authority and re- ment specified at this paragraph
sponsibility for the management of the (b)(1)(v).
CMHC, the services it furnishes, its fis- (B) The certification statement de-
cal operations, and continuous quality scribed in paragraph (b)(1)(v)(A) of this
improvement. One member of the gov- section is required upon initial applica-
erning body must possess knowledge tion to enroll in Medicare, and as a
and experience as a mental health cli- part of revalidation, including any off
nician. cycle revalidation, thereafter carried

(2) The CMHC’s governing body must out pursuant to § 424.530 of this chapter.
appoint an administrator who reports Medicare enrollment will be denied or
238
revoked in instances where the CMHC policies of the CMHC, and the client’s
fails to provide the certification state- active treatment plan.
ment as required. Medicare enrollment (d) Standard: Staff training. (1) A
will also be denied or revoked if the 40 CMHC must provide education about
percent requirement as specified in CMHC care and services, and person-
this paragraph (b)(1)(v) is not met. centered care to all employees, volun-
(vi) Provides individual and group teers, and staff under contract who
psychotherapy utilizing a psychiatrist, have contact with clients and their
psychologist, or other licensed mental families.
health counselor, to the extent author- (2) A CMHC must provide an initial
ized under State law. orientation for each individual fur-
(vii) Provides physician services. nishing services that addresses the spe-
(viii) Provides psychiatric nursing cific duties of his or her job.
services. (3) A CMHC must assess the skills
(ix) Provides clinical social work and competence of all individuals fur-
services. nishing care and, as necessary, provide
(x) Provides family counseling serv- in-service training and education pro-
ices, with the primary purpose of treat- grams where indicated. The CMHC
ing the individual’s condition. must have written policies and proce-
(xi) Provides occupational therapy dures describing its method(s) of as-
services. sessing competency and must maintain
(xii) Provides services of other staff a written description of the in-service
trained to work with psychiatric cli- training provided during the previous
ents. 12 months.
(xiii) Provides drugs and biologicals (e) Standard: Physical environment—(1)
furnished for therapeutic purposes that Environmental conditions. The CMHC
cannot be self-administered. must provide a safe, functional, sani-
(xiv) Provides client training and tary, and comfortable environment for
education as related to the individual’s clients and staff that is conducive to
care and active treatment. the provision of services that are iden-
(xv) Provides individualized thera- tified in paragraph (b) of this section.
peutic activity services that are not
(2) Building. The CMHC services must
primarily recreational or diversionary.
be provided in a location that meets
(xvi) Provides diagnostic services.
Federal, State, and local health and
(2) The CMHC and individuals fur-
safety standards and State health care
nishing services on its behalf must
occupancy regulations.
meet applicable State licensing and
(3) Infection control. There must be
certification requirements.
policies, procedures, and monitoring
(c) Standard: Professional management
for the prevention, control, and inves-
responsibility. A CMHC that has a writ-
tigation of infection and communicable
ten agreement with another agency, in-
diseases with the goal of avoiding
dividual, or organization to furnish any
sources and transmission of infection.
services under arrangement must re-
tain administrative and financial man- (4) Therapy sessions. The CMHC must
agement and oversight of staff and ensure that individual or group ther-
services for all arranged services. As apy sessions are conducted in a manner
part of retaining financial manage- that maintains client privacy and en-
ment responsibility, the CMHC must sures client dignity.
retain all payment responsibility for (f) Standard: Partial hospitalization
services furnished under arrangement services. A CMHC providing partial hos-
on its behalf. Arranged services must pitalization services must—
be supported by a written agreement (1) Provide services as defined in
which requires that all services be as § 410.2 of this chapter.
follows: (2) Provide the services and meet the
(1) Authorized by the CMHC. requirements specified in § 410.43 of this
(2) Furnished in a safe and effective chapter.
manner. (3) Meet the requirements for cov-

(3) Delivered in accordance with es- erage as described in § 410.110 of this
tablished professional standards, the chapter.
239
§ 485.920 42 CFR Ch. IV (10–1–17 Edition)
(4) Meet the content of certification (b) Policies and procedures. The CMHC
and plan of treatment requirements as must develop and implement emer-
described in § 424.24(e) of this chapter. gency preparedness policies and proce-
(g) Standard: Compliance with Federal, dures, based on the emergency plan set
State, and local laws and regulations re- forth in paragraph (a) of this section,
lated to the health and safety of clients. risk assessment at paragraph (a)(1) of
The CMHC and its staff must operate this section, and the communication
and furnish services in compliance with plan at paragraph (c) of this section.
all applicable Federal, State, and local The policies and procedures must be re-
laws and regulations related to the viewed and updated at least annually.
health and safety of clients. If State or At a minimum, the policies and proce-
local law provides for licensing of dures must address the following:
CMHCs, the CMHC must be licensed. (1) A system to track the location of
The CMHC staff must follow the on-duty staff and sheltered clients in
CMHC’s policies and procedures. the CMHC’s care during and after an
emergency. If on-duty staff and shel-
Emergency preparedness. tered clients are relocated during the
emergency, the CMHC must document
The Community Mental Health Cen- the specific name and location of the
ter (CMHC) must comply with all ap- receiving facility or other location.
plicable Federal, State, and local emer- (2) Safe evacuation from the CMHC,
gency preparedness requirements. The which includes consideration of care
CMHC must establish and maintain an and treatment needs of evacuees; staff
emergency preparedness program that responsibilities; transportation; identi-
meets the requirements of this section. fication of evacuation location(s); and
The emergency preparedness program
primary and alternate means of com-
must include, but not be limited to, the
munication with external sources of as-
following elements:
sistance.
(a) Emergency plan. The CMHC must
(3) A means to shelter in place for cli-
develop and maintain an emergency
ents, staff, and volunteers who remain
preparedness plan that must be re-
in the facility.
viewed, and updated at least annually.
The plan must do all of the following: (4) A system of medical documenta-
tion that preserves client information,
(1) Be based on and include a docu-
mented, facility-based and community- protects confidentiality of client infor-
based risk assessment, utilizing an all- mation, and secures and maintains the
hazards approach. availability of records.
(2) Include strategies for addressing (5) The use of volunteers in an emer-
emergency events identified by the gency or other emergency staffing
risk assessment. strategies, including the process and
(3) Address client population, includ- role for integration of state or Feder-
ing, but not limited to, the type of ally designated health care profes-
services the CMHC has the ability to sionals to address surge needs during
provide in an emergency; and con- an emergency.
tinuity of operations, including delega- (6) The development of arrangements
tions of authority and succession with other CMHCs or other providers
plans. to receive clients in the event of limi-
(4) Include a process for cooperation tations or cessation of operations to
and collaboration with local, tribal, re- maintain the continuity of services to
gional, State, and Federal emergency CMHC clients.
preparedness officials’ efforts to main- (7) The role of the CMHC under a
tain an integrated response during a waiver declared by the Secretary of
disaster or emergency situation, in- Health and Human Services, in accord-
cluding documentation of the CMHC’s ance with section 1135 of the Social Se-
efforts to contact such officials and, curity Act, in the provision of care and
when applicable, of its participation in treatment at an alternate care site

collaborative and cooperative planning identified by emergency management
efforts. officials.
240
(c) Communication plan. The CMHC ness policies and procedures to all new
must develop and maintain an emer- and existing staff, individuals pro-
gency preparedness communication viding services under arrangement, and
plan that complies with Federal, State, volunteers, consistent with their ex-
and local laws and must be reviewed pected roles, and maintain documenta-
and updated at least annually. The tion of the training. The CMHC must
communication plan must include all demonstrate staff knowledge of emer-
of the following: gency procedures. Thereafter, the
(1) Names and contact information CMHC must provide emergency pre-
for the following: paredness training at least annually.
(i) Staff. (2) Testing. The CMHC must conduct
(ii) Entities providing services under exercises to test the emergency plan at
arrangement. least annually. The CMHC must:
(iii) Clients’ physicians. (i) Participate in a full-scale exercise
(iv) Other CMHCs. that is community-based or when a
(v) Volunteers. community-based exercise is not acces-
(2) Contact information for the fol- sible, an individual, facility-based. If
lowing: the CMHC experiences an actual nat-
(i) Federal, State, tribal, regional, ural or man-made emergency that re-
and local emergency preparedness quires activation of the emergency
staff. plan, the CMHC is exempt from engag-
(ii) Other sources of assistance. ing in a community-based or indi-
(3) Primary and alternate means for vidual, facility-based full-scale exer-
communicating with the following: cise for 1 year following the onset of
(i) CMHC’s staff. the actual event.
(ii) Federal, State, tribal, regional,
(ii) Conduct an additional exercise
and local emergency management
that may include, but is not limited to
agencies.
the following:
(4) A method for sharing information
and medical documentation for clients (A) A second full-scale exercise that
under the CMHC’s care, as necessary, is community-based or individual, fa-
with other health care providers to cility-based.
maintain the continuity of care. (B) A tabletop exercise that includes
(5) A means, in the event of an evacu- a group discussion led by a facilitator,
ation, to release client information as using a narrated, clinically-relevant
permitted under 45 CFR 164.510(b)(1)(ii). emergency scenario, and a set of prob-
(6) A means of providing information lem statements, directed messages, or
about the general condition and loca- prepared questions designed to chal-
tion of clients under the facility’s care lenge an emergency plan.
as permitted under 45 CFR 164.510(b)(4). (iii) Analyze the CMHC’s response to
(7) A means of providing information and maintain documentation of all
about the CMHC’s needs, and its ability drills, tabletop exercises, and emer-
to provide assistance, to the authority gency events, and revise the CMHC’s
having jurisdiction or the Incident emergency plan, as needed.
Command Center, or designee. (e) Integrated healthcare systems. If a
(d) Training and testing. The CMHC CMHC is part of a healthcare system
must develop and maintain an emer- consisting of multiple separately cer-
gency preparedness training and test- tified healthcare facilities that elects
ing program that is based on the emer- to have a unified and integrated emer-
gency plan set forth in paragraph (a) of gency preparedness program, the
this section, risk assessment at para- CMHC may choose to participate in the
graph (a)(1) of this section, policies and healthcare system’s coordinated emer-
procedures at paragraph (b) of this sec- gency preparedness program. If elected,
tion, and the communication plan at the unified and integrated emergency
paragraph (c) of this section. The train- preparedness program must do all of
ing and testing program must be re- the following:
viewed and updated at least annually. (1) Demonstrate that each separately
(1) Training. The CMHC must provide certified facility within the system ac-
initial training in emergency prepared- tively participated in the development
241
of the unified and integrated emer- 486.108 Condition for coverage: Safety
gency preparedness program. standards.
(2) Be developed and maintained in a 486.110 Condition for coverage: Inspection of
manner that takes into account each equipment.
separately certified facility’s unique Subparts D–F [Reserved]
and services offered. Subpart G—Requirements for Certification
(3) Demonstrate that each separately and Designation and Conditions for
certified facility is capable of actively Coverage: Organ Procurement Orga-
using the unified and integrated emer- nizations
gency preparedness program and is in
compliance. 486.301 Basis and scope.
(4) Include a unified and integrated 486.302 Definitions.
emergency plan that meets the require- REQUIREMENTS FOR CERTIFICATION AND
ments of paragraphs (a)(2), (3), and (4) DESIGNATION
of this section. The unified and inte-
grated emergency plan must also be 486.303 Requirements for certification.
486.304 Requirements for designation.
based on and include all of the fol- 486.306 OPO service area size designation
lowing: and documentation requirements.
(i) A documented community-based 486.308 Designation of one OPO for each
risk assessment, utilizing an all-haz- service area.
ards approach. 486.309 Re-certification from August 1, 2006
(ii) A documented individual facility- through July 31, 2010.
based risk assessment for each sepa- 486.310 Changes in control or ownership or
rately certified facility within the service area.
health system, utilizing an all-hazards RE-CERTIFICATION AND DE-CERTIFICATION
approach.
(5) Include integrated policies and 486.312 De-certification.
procedures that meet the requirements 486.314 Appeals.
486.316 Re-certification and competition
set forth in paragraph (b) of this sec-
processes.
tion, a coordinated communication
plan and training and testing programs ORGAN PROCUREMENT ORGANIZATION OUTCOME
that meet the requirements of para- REQUIREMENTS
graphs (c) and (d) of this section, re- 486.318 Condition: Outcome measures.
spectively.
ORGAN PROCUREMENT ORGANIZATION PROCESS
[81 FR 64039, Sept. 16, 2016] PERFORMANCE MEASURES
486.320 Condition: Participation in Organ
PART 486—CONDITIONS FOR COV- Procurement and Transplantation Net-
ERAGE OF SPECIALIZED SERVICES work.
FURNISHED BY SUPPLIERS 486.322 Condition: Relationships with hos-
pitals, critical access hospitals, and tis-
Subpart A—General Provisions sue banks.
486.324 Condition: Administration and gov-
Sec. erning body.
486.1 Basis and scope. 486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
Subpart B [Reserved] 486.330 Condition: Information manage-
ment.
Subpart C—Conditions for Coverage: 486.342 Condition: Requesting consent.
Portable X-Ray Services 486.344 Condition: Evaluation and manage-
ment of potential donors and organ
486.100 Condition for coverage: Compliance placement and recovery.
with Federal, State, and local laws and 486.346 Condition: Organ preparation and
regulations. transport.
486.102 Condition for coverage: Supervision 486.348 Condition: Quality assessment and
by a qualified physician. performance improvement (QAPI).
486.104 Condition for coverage: Qualifica-
486.360 Condition for Coverage: Emergency
tions, orientation, and health of tech-

preparedness.
nical personnel.
486.106 Condition for coverage: Referral for AUTHORITY: Secs. 1102, 1138, and 1871 of the
service and preservation of records. Social Security Act (42 U.S.C. 1302, 1320b-8,
242
and 1395hh) and section 371 of the Public § 486.100 Condition for coverage: Com-
Health Service Act (42 U.S.C 273). pliance with Federal, State, and
local laws and regulations.
Subpart A—General Provisions The supplier of portable X-ray serv-
ices is in conformity with all applica-
§ 486.1 Basis and scope.
ble Federal, State, and local laws and
(a) Statutory basis. This part is based regulations.
on the following sections of the Act: (a) Standard—licensure or registration
1102 and 1138(b), 1871 of the Social Security of supplier. In any State in which State
Act, section 371(b) of the Public Health Serv- or applicable local law provides for the
ice Act—for coverage of organ procurement licensure or registration of suppliers of
services. X-ray services, the supplier is (1) li-
1861(p)—for coverage of outpatient physical censed or registered pursuant to such
therapy services furnished by physical thera- law, or (2) approved by the agency of
pists in independent practice.
1861(s) (3), (15), and (17)—for coverage of
the State or locality responsible for li-
portable X-ray services. censure or registration as meeting the
standards established for such licen-
(b) Scope. (1) This part sets forth the sure or registration.
conditions for coverage of certain spe- (b) Standard—licensure or registration
cialized services that are furnished by of personnel. All personnel engaged in
suppliers and that are not specified in operating portable X-ray equipment
other portions of this chapter. are currently licensed or registered in
(2) The conditions for coverage of accordance with all applicable State
other specialized services furnished by and local laws.
suppliers are set forth in the following (c) Standard—licensure or registration
regulations which, unless otherwise in- of equipment. All portable X-ray equip-
dicated, are part of this chapter: ment used in providing portable X-ray
(i) Ambulatory surgical center (ASC) services is licensed or registered in ac-
services—Part 416. cordance with all applicable State and
(ii) Ambulance services—Part 410, local laws.
subpart B. (d) Standard—conformity with other
(iii) ESRD services—Part 405, subpart Federal, State, and local laws and regula-
U. tions. The supplier of portable X-ray
(iv) Laboratory services—Part 493. services agrees to render such services
(v) Mammography services—Part 410, in conformity with Federal, State, and
subpart B (§ 410.34) and 21 CFR part 900, local laws relating to safety standards.
subpart B, of the Food and Drug Ad-
ministration regulations. [34 FR 388, Jan. 10, 1969. Redesignated at 42
(vi) Rural health clinic and Federally FR 52826, Sept. 30, 1977. Further redesignated
qualified health center services—Part and amended at 60 FR 2326, Jan. 9, 1995; 60 FR
491, subpart A. 45086, Aug. 30, 1995]
[60 FR 50447, Sept. 29, 1995, as amended at 71 § 486.102 Condition for coverage: Su-
FR 31046, May 31, 2006] pervision by a qualified physician.
Portable X-ray services are provided
Subpart B [Reserved] under the supervision of a qualified
physician.
Subpart C—Conditions for Cov- (a) Standard—physician supervision.
erage: Portable X-Ray Serv- The performance of the roentgenologic
ices procedures is subject to the supervision
of a physician who meets the require-
ments of paragraph (b) of this section
AUTHORITY: Secs. 1102, 1861(s) (3), (11) and
(12), 1864, and 1871 of the Social Security Act and one of the following requirements
(42 U.S.C. 1302, 1395x(s) (3), (11), and (12), is met:
1395aa and 1395hh). (1) The supervising physician owns
the equipment and it is operated only
SOURCE: 34 FR 388, Jan. 10, 1969, unless oth-

erwise noted. Redesignated at 42 FR 52826, by his employees, or
Sept. 30, 1977, and further redesignated and (2) The supervising physician cer-
amended at 60 FR 2326, Jan. 9, 1995. tifies annually that he periodically
243
§ 486.104 42 CFR Ch. IV (10–1–17 Edition)
checks the procedural manuals and ob- Radiology or who possesses qualifica-
serves the operators’ performance, that tions which are equivalent to those re-
he has verified that equipment and per- quired for such certification, and at
sonnel meet applicable Federal, State, least 12 full months of pertinent port-
and local licensure and registration re- able X-ray equipment operation experi-
quirements and that safe operating ence in the 5 years prior to January 1,
procedures are used. 1968.
(b) Standard—qualifications of the phy- (3) For those whose training was
sician supervisor. Portable X-ray serv- completed prior to July 1, 1960: Suc-
ices are provided under the supervision cessful completion of 24 full months of
of a licensed doctor of medicine or li- training and/or experience of which at
censed doctor of osteopathy who is least 12 full months were under the di-
qualified by advanced training and ex- rect supervision of a physician who is
perience in the use of X-rays for diag- certified in radiology by the American
nostic purposes, i.e., he (1) is certified College of Radiology or who possesses
in radiology by the American Board of qualifications which are equivalent to
Radiology or by the American Osteo- those required for such certification,
pathic Board of Radiology or possesses and at least 12 full months of pertinent
qualifications which are equivalent to portable X-ray equipment operation ex-
those required for such certification, or perience in the 5 years prior to Janu-
(2) is certified or meets the require- ary 1, 1968.
ments for certification in a medical (4) For those whose training was
specialty in which he has become completed prior to January 1, 1993, suc-
qualified by experience and training in cessful completion of a program of for-
the use of X-rays for diagnostic pur- mal training in X-ray technology in a
poses, or (3) specializes in radiology school approved by the Council on Edu-
and is recognized by the medical com- cation of the American Medical Asso-
munity as a specialist in radiology. ciation, or by the American Osteo-
pathic Association is acceptable.
[34 FR 388, Jan. 10, 1969. Redesignated at 42
FR 52826, Sept. 30, 1977. Further redesignated (b) Standard—personnel orientation.
and amended at 60 FR 2326, Jan. 9, 1995; 60 FR The supplier of portable X-ray services
45086, Aug. 30, 1995] has an orientation program for per-
sonnel, based on a procedural manual
§ 486.104 Condition for coverage: which is: Available to all members of
Qualifications, orientation and the staff, incorporates relevant por-
health of technical personnel. tions of professionally recognized docu-
Portable X-ray services are provided ments, and includes instruction in all
by qualified technologists. of the following:
(a) Standard-qualifications of tech- (1) Precautions to be followed to pro-
nologists. All operators of the portable tect the patient from unnecessary ex-
X-ray equipment meet the require- posure to radiation;
ments of paragraphs (a)(1), (2), (3), or (2) Precautions to be followed to pro-
(4) of this section: tect an individual supporting the pa-
(1) Successful completion of a pro- tient during X-ray procedures from un-
gram of formal training in X-ray tech- necessary exposure to radiation;
nology in a school approved by the (3) Precautions to be followed to pro-
Joint Review Committee on Education tect other individuals in the sur-
in Radiologic Technology (JRCERT), rounding environment from exposure
or have earned a bachelor’s or asso- to radiation;
ciate degree in radiologic technology (4) Precautions to be followed to pro-
from an accredited college or univer- tect the operator of portable X-ray
sity. equipment from unnecessary exposure
(2) For those whose training was to radiation;
completed prior to July 1, 1966, but on (5) Considerations in determining the
or after July 1, 1960: Successful comple- area which will receive the primary
tion of 24 full months of training and/ beam;
or experience under the direct super- (6) Determination of the time inter-
vision of a physician who is certified in val at which to check personnel radi-
radiology by the American College of ation monitors;
244
(7) Use of the personnel radiation cates why portable X-ray services are
monitor in providing an additional necessary.
check on safety of equipment; (b) Standard—records of examinations
(8) Proper use and maintenance of performed. The supplier makes for each
equipment; patient a record of the date of the port-
(9) Proper maintenance of records; able X-ray examination, the name of
(10) Technical problems which may the patient, a description of the proce-
arise and methods of solution; dures ordered and performed, the refer-
(11) Protection against electrical haz- ring physician or nonphysician practi-
ards; tioner, the operator(s) of the portable
(12) Hazards of excessive exposure to X-ray equipment who performed the
radiation. examination, the physician to whom
(c) Standard: Employee records. the radiograph was sent, and the date
Records are maintained and include it was sent.
evidence that— (c) Standard—preservation of records.
(1) Each employee is qualified for his Such reports are maintained for a pe-
or her position by means of training riod of at least 2 years, or for the pe-
and experience; and riod of time required by State law for
(2) Employees receive adequate such records (as distinguished from re-
health supervision. quirements as to the radiograph itself),
whichever is longer.
FR 52826, Sept. 30, 1977, and amended at 53 [34 FR 388, Jan. 10, 1969. Redesignated at 42
FR 12015, Apr. 12, 1988; 60 FR 45086, Aug. 30, FR 52826, Sept. 30, 1977. Further redesignated
1995; 73 FR 69942, Nov. 19, 2008] and amended at 60 FR 2326, Jan. 9, 1995; 60 FR
45086, Aug. 30, 1995; 77 FR 69372, Nov. 16, 2012]
§ 486.106 Condition for coverage: Re-
ferral for service and preservation § 486.108 Condition for coverage: Safe-
of records. ty standards.
All portable X-ray services performed X-ray examinations are conducted
for Medicare beneficiaries are ordered through the use of equipment which is
by a physician or a nonphysician prac- free of unnecessary hazards for pa-
titioner as provided in § 410.32(a) of this tients, personnel, and other persons in
chapter or by a nonphysician practi- the immediate environment, and
tioner as provided in § 410.32(a)(2) and through operating procedures which
records are properly preserved. provide minimum radiation exposure
(a) Standard—referral by a physician or to patients, personnel, and other per-
nonphysician practitioners. Portable X- sons in the immediate environment.
ray examinations are performed only (a) Standard—tube housing and devices
on the order of a physician licensed to to restrict the useful beam. The tube
practice in the State or by a nonphysi- housing is of diagnostic type. Dia-
cian practitioner acting within the phragms, cones, or adjustable collima-
scope of State law. Such nonphysician tors capable of restricting the useful
practitioners may be treated the same beam to the area of clinical interest
as physicians treating beneficiaries for are used and provide the same degree of
the purpose of this paragraph. The sup- protection as is required of the hous-
plier’s records show that: ing.
(1) The portable X-ray test was or- (b) Standard—total filtration. (1) The
dered by a licensed physician or a non- aluminum equivalent of the total fil-
physician practitioner acting within tration in the primary beam is not less
the State scope of law; and than that shown in the following table
(2) Such physician or nonphysician except when contraindicated for a par-
practitioner’s written, signed order ticular diagnostic procedure.
specifies the reason a portable X-ray
Total filtration (inherent plus
test is required, the area of the body to Operating kVp added)
be exposed, the number of radiographs
to be obtained, and the views needed; it Below 50 kVp .................. 0.5 millimeters aluminum.
50–70 kVp ....................... 1.5 millimeters aluminum.
also includes a statement concerning
Above 70 kVp ................. 2.5 millimeters aluminum.
the condition of the patient which indi-
245
§ 486.110 42 CFR Ch. IV (10–1–17 Edition)
(2) If the filter in the machine is not radiation exposure (e.g., a film badge)
accessible for examination or the total is provided to each individual who op-
filtration is unknown, it can be as- erates portable X-ray equipment. The
sumed that the requirements are met if device is evaluated for radiation expo-
the half-value layer is not less than sure to the operator at least monthly
that shown in the following table: and appropriate records are maintained
by the supplier of portable X-ray serv-
Operating kVp Half-value layer
ices of radiation exposure measured by
50 kVp ............................. 0.6 millimeters aluminum. such a device for each individual.
70 kVp ............................. 1.6 millimeters aluminum. (k) Standard—personnel and public
90 kVp ............................. 2.6 millimeters aluminum.
100 kVp ........................... 2.8 millimeters aluminum.
protection. No individual occupation-
110 kVp ........................... 3.0 millimeters aluminum. ally exposed to radiation is permitted
120 kVp ........................... 3.3 millimeters aluminum. to hold patients during exposures ex-
cept during emergencies, nor is any
(c) Standard—termination of exposure. other individual regularly used for this
A device is provided to terminate the service. Care is taken to assure that
exposure after a preset time or expo- pregnant women do not assist in port-
sure. able X-ray examinations.
(d) Standard—control panel. The con-
trol panel provides a device (usually a [34 FR 388, Jan. 10, 1969. Redesignated at 42
FR 52826, Sept. 30, 1977. Further redesignated
milliammeter or a means for an audi- and amended at 60 FR 2326, Jan. 9, 1995; 60 FR
ble signal to give positive indication of 45086, Aug. 30, 1995]
the production of X-rays whenever the
X-ray tube is energized. The control § 486.110 Condition for coverage: In-
panel includes appropriate indicators spection of equipment.
(labelled control settings and/or me-
Inspections of all X-ray equipment
ters) which show the physical factors
and shielding are made by qualified in-
(such as kVp, mA, exposure time or
dividuals at intervals not greater than
whether timing is automatic) used for
every 24 months.
the exposure.
(a) Standard—qualified inspectors. In-
(e) Standard—exposure control switch.
spections are made at least every 24
The exposure control switch is of the
months by a radiation health specialist
dead-man type and is so arranged that
who is on the staff of or approved by an
the operator can stand at least 6 feet
appropriate State or local government
from the patient and well away from
agency.
the useful beam.
(f) Standard—protection against elec- (b) Standard—records of inspection and
trical hazards. Only shockproof equip- scope of inspection. The supplier main-
ment is used. All electrical equipment tains records of current inspections
is grounded. which include the extent to which
(g) Standard—mechanical supporting or equipment and shielding are in compli-
restraining devices. Mechanical sup- ance with the safety standards outlined
porting or restraining devices are pro- in § 486.108.
vided so that such devices can be used [34 FR 388, Jan. 10, 1969. Redesignated at 42
when a patient must be held in position FR 52826, Sept. 30, 1977. Further redesignated
for radiography. and amended at 60 FR 2326, Jan. 9, 1995; 60 FR
(h) Standard—protective gloves and 45086, Aug. 30, 1995; 60 FR 50447, Sept. 29, 1995]
aprons. Protective gloves and aprons
are provided so that when the patient Subparts D–F [Reserved]
must be held by an individual, that in-
dividual is protected with these shield- Subpart G—Requirements for Cer-
ing devices.
(i) Standard—restriction of the useful
tification and Designation and
beam. Diaphragms, cones, or adjustable Conditions for Coverage:
collimators are used to restrict the Organ Procurement Organiza-
useful beam to the area of clinical in- tions
terest.
(j) Standard—personnel monitoring. A SOURCE: 71 FR 31046, May 31, 2006, unless
device which can be worn to monitor otherwise noted.
246
§ 486.301 Basis and scope. Certification means a CMS determina-

tion that an OPO meets the require-
(a) Statutory basis. (1) Section 1138(b)
ments for certification at § 486.303.
of the Act sets forth the requirements
that an organ procurement organiza- Death record review means an assess-
tion (OPO) must meet to have its organ ment of the medical chart of a de-
procurement services to hospitals cov- ceased patient to evaluate potential for
ered under Medicare and Medicaid. organ donation.
These include certification as a Decertification means a CMS deter-
‘‘qualified’’ OPO and designation as the mination that an OPO no longer meets
OPO for a particular service area. the requirements for certification at
(2) Section 371(b) of the Public Health § 486.303.
Service Act sets forth the requirements Designated requestor or effective re-
for certification and the functions that questor is an individual (generally em-
a qualified OPO is expected to perform. ployed by a hospital), who is trained to
(3) Section 1102 of the Act authorizes handle or participate in the donation
the Secretary of Health and Human consent process. The designated re-
Services to make and publish rules and questor may request consent for dona-
regulations necessary to the efficient tion from the family of a potential
administration of the functions that donor or from the individual(s) respon-
are assigned to the Secretary under the sible for making the donation decision
Act. in circumstances permitted under
(4) Section 1871 of the Act authorizes State law, provide information about
the Secretary to prescribe regulations donation to the family or decision-
as may be necessary to carry out the maker(s), or provide support to or col-
administration of the Medicare pro- laborate with the OPO in the donation
gram under title XVIII. consent process.
(b) Scope. This subpart sets forth— Designation means CMS assignment
(1) The conditions and requirements of a geographic service area to an OPO.
that an OPO must meet; Once an OPO is certified and assigned a
(2) The procedures for certification geographic service area, organ procure-
and designation of OPOs; and ment costs of the OPO are eligible for
(3) The terms of the agreement with Medicare and Medicaid payment under
CMS and the basis for and the effect of section 1138(b)(1)(F) of the Act.
de-certification. Donation service area (DSA) means a
(4) The requirements for an OPO to geographical area of sufficient size to
be re-certified. ensure maximum effectiveness in the
procurement and equitable distribution
§ 486.302 Definitions. of organs and that either includes an
As used in this subpart, the following entire metropolitan statistical area or
definitions apply: does not include any part of such an
Adverse event means an untoward, un- area and that meets the standards of
desirable, and usually unanticipated this subpart.
event that causes death or serious in- Donor means a deceased individual
jury or the risk thereof. As applied to from whom at least one vascularized
OPOs, adverse events include but are organ (heart, liver, lung, kidney, pan-
not limited to transmission of disease creas, or intestine) is recovered for the
from a donor to a beneficiary, avoid- purpose of transplantation.
able loss of a medically suitable poten- Donor after cardiac death (DCD)
tial donor for whom consent for dona- means an individual who donates after
tion has been obtained, or delivery to a his or her heart has irreversibly
transplant center of the wrong organ stopped beating. A donor after cardiac
or an organ whose blood type does not death may be termed a non-
match the blood type of the intended heartbeating or asystolic donor.
beneficiary. Donor document means any docu-
Agreement cycle refers to the time pe- mented indication of an individual’s
riod of at least 4 years when an agree- choice regarding his or her wishes con-
ment is in effect between CMS and an cerning organ and/or tissue donation
OPO. that was made by that individual or
247
§ 486.302 42 CFR Ch. IV (10–1–17 Edition)
another authorized individual in ac- (C) Has a history of Coronary Artery

cordance with any applicable State Bypass Graft (CABG);
law.’’ (D) Has a history of coronary stent/
Eligible death. An eligible death for intervention;
organ donation means the death of a (E) Has a current or past medical his-
person— tory of myocardial infarction (MI);
(1) Who is 75 years old or younger; (F) Has a severe vessel diagnosis as
(2) Who is legally declared dead by supported by cardiac catheterization
neurologic criteria in accordance with (that is more than 50 percent occlusion
State or local law; or 2+ vessel disease);
(3) Whose body weight is 5 kg or (G) Has acute myocarditis and/or en-
greater; docarditis;
(4) Whose body mass Index (BMI) is 50 (H) Has heart failure due to cardio-
kg/m2 or less; myopathy;
(5) Who had at least one kidney, (I) Has an internal defibrillator or
liver, heart, or lung that is deemed to pacemaker;
meet the eligible data definition as fol- (J) Has moderate to severe single
lows: valve or 2-valve disease documented by
(i) The kidney would be initially echo or cardiac catheterization, or pre-
deemed to meet the eligible data defi- vious valve repair;
nition unless the donor meets one of (K) Has serial echo results showing
the following: severe global hypokinesis;
(A) Is more than 70 years of age; (L) Has myxoma; or
(B) Is age 50–69 years with history of (M) Has congenital defects (whether
Type 1 diabetes for more than 20 years; surgically corrected or not).
(iv) The lung would be initially
(C) Has polycystic kidney disease;
deemed to meet the eligible data defi-
(D) Has glomerulosclerosis equal to
nition unless the donor meets one of
or more than 20 percent by kidney bi-
the following:
opsy;
(A) Is more than 65 years of age;
(E) Has terminal serum creatinine
(B) Is diagnosed with coronary ob-
greater than 4/0 mg/dl;
structive pulmonary disease (COPD)
(F) Has chronic renal failure; or (for example, emphysema);
(G) Has no urine output for at least (C) Has terminal PaO2/FiO2 less than
or more than 24 hours; 250 mmHg;
(ii) The liver would be initially (D) Has asthma (with daily prescrip-
deemed to meet the eligible data defi- tion);
nition unless the donor has one of the (E) Asthma is the cause of death;
following: (F) Has pulmonary fibrosis;
(A) Cirrhosis; (G) Has previous lobectomy;
(B) Terminal total bilirubin equal to (H) Has multiple blebs documented
or more than 4 mg/dl; on Computed Axial Tomography (CAT)
(C) Portal hypertension; Scan;
(D) Macrosteatosis equal to or more (I) Has pneumonia as indicated on
than 50 percent or fibrosis equal to or Computed Tomography (CT), X-ray,
more than stage II; bronchoscopy, or cultures;
(E) Fulminant hepatic failure; or (J) Has bilateral severe pulmonary
(F) Terminal AST/ALT of more than contusions as per CT.
700 U/L. (6) If a deceased person meets the cri-
(iii) The heart would be initially teria specified in paragraphs (1)
deemed to meet the eligible data defi- through (5) of this definition, the death
nition unless the donor meets one of of the person would be classified as an
the following: eligible death, unless the donor meets
(A) Is more than 60 years of age; any of the following criteria:
(B) Is at least or more than 45 years (i) The donor was taken to the oper-
of age with a history of at least or ating room with the intent for the OPO
more than 10 years of HTN or at least to recover organs for transplant and all
or more than 10 years of type 1 diabe- organs were deemed not medically
tes; suitable for transplantation; or
248
(ii) The donor exhibits any of the fol- Entire metropolitan statistical area
lowing active infections (specific diag- means a metropolitan statistical area
noses) of— (MSA), a consolidated metropolitan
(A) Bacterial: Tuberculosis, Gangre- statistical area (CMSA), or a primary
nous bowel or perforated bowel or metropolitan statistical area (PMSA)
intra-abdominal sepsis; listed in the State and Metropolitan
(B) Viral: HIV infection by serologic Area Data Book published by the U.S.
or molecular detection, Rabies, Reac- Bureau of the Census. CMS does not
tive Hepatitis B Surface Antigen, recognize a CMSA as a metropolitan
Retroviral infections including Viral area for the purposes of establishing a
Encephalitis or Meningitis, Active Her- geographical area for an OPO.
pes simplex, varicella zoster, or Expected donation rate means the do-
cytomegalovirus viremia or pneu- nation rate expected for an OPO based
monia, Acute Epstein Barr Virus (mon- on the national experience for OPOs
onucleosis), West Nile (c) Virus infec- serving similar hospitals and donation
tion, SARS, except as provided in para- service areas. This rate is adjusted for
graph (8) of this definition. the following hospital characteristics:
(C) Fungal: Active infection with Level I or Level II trauma center, Met-
Cryptococcus, Aspergillus, ropolitan Statistical Area size, MS
Histoplasma, Coccidioides, Active Case Mix Index, total bed size, number
candidemia or invasive yeast infection; of intensive care unit (ICU) beds, pri-
(D) Parasites: Active infection with mary service, presence of a neuro-
Trypanosoma cruzi (Chagas’), surgery unit, and hospital control/own-
Leishmania, Strongyloides, or Malaria ership.
(Plasmodium sp.); or Observed donation rate is the number
(E) Prion: Creutzfeldt-Jacob Disease. of donors meeting the eligibility cri-
(7) The following are general exclu- teria per 100 deaths.
sions: Open area means an OPO service area
for which CMS has notified the public
(i) Aplastic anemia, Agranulocytosis;
that it is accepting applications for
(ii) Current malignant neoplasms ex-
designation.
cept non-melanoma skin cancers such
Organ means a human kidney, liver,
as basal cell and squamous cell cancer
heart, lung, pancreas, or intestine (or
and primary CNS tumors without evi-
multivisceral organs when trans-
dent metastatic disease;
planted at the same time as an intes-
(iii) Previous malignant neoplasms tine).
with current evident metastatic dis- Organ procurement organization (OPO)
ease; means an organization that performs
(iv) A history of melanoma; or coordinates the procurement, pres-
(v) Hematologic malignancies: Leu- ervation, and transport of organs and
kemia, Hodgkin’s Disease, Lymphoma, maintains a system for locating pro-
Multiple Myeloma; spective beneficiaries for available or-
(vi) Active Fungal, Parasitic, Viral, gans.
or Bacterial Meningitis or Encepha- Re-certification cycle means the 4-year
litis; and cycle during which an OPO is certified.
(vii) No discernable cause of death. Standard criteria donor (SCD) means a
(8) Notwithstanding paragraph donor that meets the eligibility cri-
(6)(ii)(B) of this definition, an HIV posi- teria for an eligible donor and does not
tive organ procured for the purpose of meet the criteria to be a donor after
transplantation into an HIV positive cardiac death or expanded criteria
recipient would be an exception to an donor.
active infection rule out, consistent Transplant hospital means a hospital
with the HIV Organ Policy Equity Act that provides organ transplants and
(the Hope Act). other medical and surgical specialty
Eligible donor means any donor that services required for the care of trans-
meets the eligible death criteria. The plant patients. There may be one or
number of eligible donors is the numer- more types of organ transplant centers
ator of the donation rate outcome per- operating within the same transplant
formance measure. hospital.
249
§ 486.303 42 CFR Ch. IV (10–1–17 Edition)
Urgent need occurs when an OPO’s § 486.304 Requirements for designa-

noncompliance with one or more condition.
tions for coverage has caused, or is (a) Designation is a condition for
likely to cause, serious injury, harm, payment. Payment may be made under
impairment, or death to a potential or the Medicare and Medicaid programs
actual donor or an organ beneficiary. for organ procurement costs attrib-
[71 FR 31046, May 31, 2006, as amended at 77 utable to payments made to an OPO by
FR 29031, May 16, 2012; 81 FR 79880, Nov. 14, a hospital only if the OPO has been
2016] designated by CMS as an OPO.
(b) An OPO must be certified as a
REQUIREMENTS FOR CERTIFICATION AND qualified OPO by CMS under 42 U.S.C.
DESIGNATION 273(b) and § 486.303 to be eligible for des-
ignation.
§ 486.303 Requirements for certifi- (c) An OPO must enter into an agree-
cation. ment with CMS in order for the organ
In order to be certified as a qualified procurement costs attributable to the
OPO to be reimbursed under Medicare
organ procurement organization, an
and Medicaid.
organ procurement organization must:
(a) Have received a grant under 42 § 486.306 OPO service area size des-
U.S.C. 273(a) or have been certified or ignation and documentation re-
re-certified by the Secretary within the quirements.
previous 4 years as being a qualified (a) General documentation requirement.
OPO. An OPO must make available to CMS
(b) Be a non-profit entity that is ex- documentation verifying that the OPO
empt from Federal income taxation meets the requirements of paragraphs
under section 501 of the Internal Rev- (b) and (c) of this section at the time of
enue Code of 1986. application and throughout the period
(c) Have accounting and other fiscal of its designation.
procedures necessary to assure the fis- (b) Service area designation. The de-
cal stability of the organization, in- fined service area either includes an
cluding procedures to obtain payment entire metropolitan statistical area or
for kidneys and non-renal organs pro- a New England county metropolitan
vided to transplant hospitals. statistical area as specified by the Di-
(d) Have an agreement with CMS, as rector of the Office of Management and
the Secretary’s designated representa- Budget or does not include any part of
tive, to be reimbursed under title XVIII such an area.
(c) Service area location and character-
for the procurement of kidneys.
istics. An OPO must define and docu-
(e) Have been re-certified as an OPO ment a proposed service area’s location
under the Medicare program from Jan- through the following information:
uary 1, 2002 through December 31, 2005. (1) The names of counties (or parishes
(f) Have procedures to obtain pay- in Louisiana) served or, if the service
ment for non-renal organs provided to area includes an entire State, the name
transplant centers. of the State.
(g) Agree to enter into an agreement (2) Geographic boundaries of the serv-
with any hospital or critical access ice area.
hospital in the OPO’s service area, in- (3) The number and the names of all
cluding a transplant hospital that re- hospitals and critical access hospitals
quests an agreement. in the service area that have both a
(h) Meet the conditions for coverage ventilator and an operating room.
for organ procurement organizations, [71 FR 31046, May 31, 2006, as amended at 79
which include both outcome and proc- FR 27156, May 12, 2014]
ess performance measures.
(i) Meet the provisions of titles XI, § 486.308 Designation of one OPO for
XVIII, and XIX of the Act, section each service area.
371(b) of the Public Health Services (a) CMS designates only one OPO per
Act, and any other applicable Federal service area. A service area is open for
regulations. competition when the OPO for the
250
service area is de-certified and all ad- of metropolitan statistical areas, if ap-
ministrative appeals under § 486.314 are plicable; and
exhausted. (4) The length and continuity of a
(b) Designation periods— hospital’s relationship with an OPO
(1) General. An OPO is normally des- other than the hospital’s designated
ignated for a 4-year agreement cycle. OPO.
The period may be shorter, for exam- (g) A hospital may continue to oper-
ple, if an OPO has voluntarily termi- ate under its existing agreement with
nated its agreement with CMS and an out-of-area OPO while CMS is proc-
CMS selects a successor OPO for the essing the waiver request. If a waiver
balance of the 4-year agreement cycle. request is denied, a hospital must enter
In rare situations, a designation period into an agreement with the designated
may be longer, for example, a designa- OPO within 30 days of notification of
tion may be extended if additional the final determination.
time is needed to select a successor
OPO to replace an OPO that has been
FR 27156, May 12, 2014]
de-certified.
(2) Re-Certification. Re-certification § 486.309 Re-certification from August
must occur not more frequently than 1, 2006 through July 31, 2010.
once every 4 years.
An OPO will be considered to be re-
(c) Unless CMS has granted a hos-
certified for the period of August 1, 2006
pital a waiver under paragraphs
through July 31, 2010 if an OPO met the
(d) through (f) of this section, the standards to be a qualified OPO within
hospital must enter into an agreement a 4-year period ending December 31,
only with the OPO designated to serve 2001 and has an agreement with the
the area in which the hospital is lo- Secretary that is scheduled to termi-
cated. nate on July 31, 2006. Agreements based
(d) If CMS changes the OPO des- on the August 1, 2006 through July 31,
ignated for an area, hospitals located 2010 re-certification cycle will end on
in that area must enter into agree- January 31, 2011.
ments with the newly designated OPO
or submit a request for a waiver in ac- § 486.310 Changes in control or owner-
cordance with paragraph (e) of this sec- ship or service area.
tion within 30 days of notice of the
(a) OPO requirements. (1) A designated
change in designation.
OPO considering a change in control
(e) A hospital may request and CMS (see § 413.17(b)(3)) or ownership or in its
may grant a waiver permitting the hos- service area must notify CMS before
pital to have an agreement with a des- putting it into effect. This notification
ignated OPO other than the OPO des- is required to ensure that the OPO, if
ignated for the service area in which changed, will continue to satisfy Medi-
the hospital is located. To qualify for a care and Medicaid requirements. The
waiver, the hospital must submit data merger of one OPO into another or the
to CMS establishing that— consolidation of one OPO with another
(1) The waiver is expected to increase is considered a change in control or
organ donations; and ownership.
(2) The waiver will ensure equitable (2) A designated OPO considering a
treatment of patients listed for trans- change in its service area must obtain
plants within the service area served prior CMS approval. In the case of a
by the hospital’s designated OPO and service area change that results from a
within the service area served by the change of control or ownership due to
OPO with which the hospital seeks to merger or consolidation, the OPOs
enter into an agreement. must resubmit the information re-
(f) In making a determination on quired in an application for designa-
waiver requests, CMS considers— tion. The OPO must provide informa-
(1) Cost effectiveness; tion specific to the board structure of
(2) Improvements in quality; the new organization, as well as oper-

(3) Changes in a hospital’s designated ating budgets, financial information,
OPO due to changes in the definitions and other written documentation CMS
251
§ 486.312 42 CFR Ch. IV (10–1–17 Edition)
determines to be necessary for designa- meets the requirements for certifi-

tion. cation at § 486.303. CMS may also termi-
(b) CMS requirements. (1) If CMS finds nate an agreement immediately in
that the OPO has changed to such an cases of urgent need, such as the dis-
extent that it no longer satisfies the covery of unsound medical practices.
requirements for OPO designation, CMS will de-certify the OPO as of the
CMS may de-certify the OPO and de- effective date of the involuntary termi-
clare the OPO’s service area to be an nation.
open area. An OPO may appeal such a (c) Non-renewal of agreement. CMS
de-certification as set forth in § 486.314. will not voluntarily renew its agree-
The OPO’s service area is not opened
ment with an OPO if the OPO fails to
for competition until the conclusion of
meet the requirements for certification
the administrative appeals process.
at § 486.318, based on findings from the
(2) If CMS finds that the changed
OPO continues to satisfy the require- most recent re-certification cycle, or
ments for OPO designation, the period the other requirements for certifi-
of designation of the changed OPO is cation at § 486.303. CMS will de-certify
the remaining portion of the 4-year the OPO as of the ending date of the
term of the OPO that was reorganized. agreement.
If more than one designated OPO is in- (d) Notice to OPO. Except in cases of
volved in the reorganization, the re- urgent need, CMS gives written notice
maining designation term is the long- of de-certification to an OPO at least 90
est of the remaining periods unless days before the effective date of the de-
CMS determines that a shorter period certification. In cases of urgent need,
is in the best interest of the Medicare CMS gives written notice of de-certifi-
and Medicaid programs. The changed cation to an OPO at least 3 calendar
OPO must continue to meet the re- days prior to the effective date of the
quirements for certification at § 486.303 de-certification. The notice of de-cer-
throughout the remaining period. tification states the reasons for de-cer-
tification and the effective date.
RE-CERTIFICATION AND DE-
CERTIFICATION (e) Public notice. Once CMS approves
the date for a voluntary termination,
§ 486.312 De-certification. the OPO must provide prompt public
(a) Voluntary termination of agreement. notice in the service area of the date of
If an OPO wishes to terminate its de-certification and such other infor-
agreement, the OPO must send CMS mation as CMS may require. In the
written notice of its intention to ter- case of involuntary termination or
minate its agreement and the proposed nonrenewal of an agreement, CMS also
effective date. CMS may approve the provides notice to the public in the
proposed date, set a different date no service area of the date of de-certifi-
later than 6 months after the proposed cation. No payment under titles XVIII
effective date, or set a date less than 6 or XIX of the Act will be made with re-
months after the proposed effective spect to organ procurement costs at-
date if it determines that a different tributable to the OPO on or after the
date would not disrupt services to the effective date of de-certification.
service area. If CMS determines that a
designated OPO has ceased to furnish
FR 38515, Aug. 14, 2017]
organ procurement services to its serv-
ice area, the cessation of services is § 486.314 Appeals.
deemed to constitute a voluntary ter-
mination by the OPO, effective on a If an OPO’s de-certification is due to
date determined by CMS. CMS will de- involuntary termination or non-re-
certify the OPO as of the effective date newal of its agreement with CMS, the
of the voluntary termination. OPO may appeal the de-certification on
(b) Involuntary termination of agree- substantive and procedural grounds.
ment. During the term of the agree- (a) Notice of initial determination. CMS
ment, CMS may terminate an agree- mails notice to the OPO of an initial
ment with an OPO if the OPO no longer
252
de-certification determination. The no- (iv) Correspondence between CMS

tice contains the reasons for the deter- and the affected OPO.
mination, the effect of the determina- (2) The administrative record will not
tion, and the OPO’s right to seek re- include any privileged information.
consideration. (e) Pre-Hearing conference. At any
(b) Reconsideration. (1) Filing request. time before the hearing, the CMS hear-
If the OPO is dissatisfied with the de- ing officer may call a pre-hearing con-
certification determination, it has 15 ference if he or she believes that a con-
business days from receipt of the no- ference would more clearly define the
tice of de-certification to seek recon- issues. At the pre-hearing conference,
sideration from CMS. The request for the hearing officer may establish the
reconsideration must state the issues briefing schedule, sets the hearing
or findings of fact with which the OPO date, and addresses other administra-
disagrees and the reasons for disagree- tive matters. The hearing officer will
ment. issue an order reflecting the results of
(2) An OPO must seek reconsider- the pre-hearing conference.
ation before it is entitled to seek a (f) Date of hearing. The hearing offi-
hearing before a hearing officer. If an cer sets a date for the hearing that is
OPO does not request reconsideration no more than 60 calendar days fol-
or its request is not made timely, the lowing the receipt of the request for a
OPO has no right to further adminis- hearing.
trative review. (g) Conduct of hearing. (1) The hearing
is open to both parties, CMS and the
(3) Reconsideration determination. CMS
OPO.
makes a written reconsidered deter-
(2) The hearing officer inquires fully
mination within 10 business days of re-
into all the matters at issue and re-
ceipt of the request for reconsider-
ceives in evidence the testimony of
ation, affirming, reversing, or modi-
witnesses and any documents that are
fying the initial determination and the
relevant and material.
findings on which it was based. CMS
(3) The hearing officer provides the
augments the administrative record to
parties with an opportunity to enter an
include any additional materials sub-
objection to the inclusion of any docu-
mitted by the OPO, and a copy of the
ment. The hearing officer will consider
reconsideration decision and sends the
the objection and will rule on the docu-
supplemented administrative record to
ment’s admissibility.
the CMS hearing officer.
(4) The hearing officer decides the
(c) Request for hearing. An OPO dis-
order in which the evidence and the ar-
satisfied with the CMS reconsideration guments of the parties are presented
decision, must file a request for a hear- and the conduct of the hearing.
ing before a CMS hearing officer within (5) The hearing officer rules on the
40 business days of receipt of the notice admissibility of evidence and may
of the reconsideration determination. admit evidence that would be inadmis-
If an OPO does not request a hearing or sible under rules applicable to court
its request is not received timely, the procedures.
OPO has no right to further adminis- (6) The hearing officer rules on mo-
trative review. tions and other procedural items.
(d) Administrative record. The hearing (7) The hearing officer regulates the
officer sends the administrative record course of the hearing and conduct of
to both parties within 10 business days counsel.
of receipt of the request for a hearing. (8) The hearing officer may examine
(1) The administrative record con- witnesses.
sists of, but is not limited to, the fol- (9) The hearing officer takes any ac-
lowing: tion authorized by the rules in this
(i) Factual findings from the sur- subpart.
vey(s) on the OPO conditions for cov- (h) Parties’ rights. CMS and the OPO
erage. may:
(ii) Data from the outcome measures. (1) Appear by counsel or other au-
(iii) Rankings of OPOs based on the thorized representative, in all hearing
outcome data. proceedings.
253
§ 486.316 42 CFR Ch. IV (10–1–17 Edition)
(2) Participate in any pre-hearing (2) Has been shown by survey to be in

conference held by the hearing officer. compliance with the requirements for
(3) Agree to stipulations as to facts certification at § 486.303, including the
which will be made a part of the conditions for coverage at §§ 486.320
record. through 486.348.
(4) Make opening statements at the (b) De-certification and competition. If
hearing. an OPO does not meet two out of the
(5) Present relevant evidence on the three outcome measures as described in
issues at the hearing. paragraph (a)(1) of this section or the
(6) Present witnesses, who then must requirements described in paragraph
be available for cross-examination, and (a)(2) of this section, the OPO is de-cer-
cross-examine witnesses presented by tified. If the OPO does not appeal or
the other party. the OPO appeals and the reconsider-
(7) Present oral arguments at the ation official and CMS hearing officer
hearing. uphold the de-certification, the OPO’s
service area is opened for competition
(i) Hearing officer’s decision. The
from other OPOs. The de-certified OPO
hearing officer renders a decision on
is not permitted to compete for its
the appeal of the notice of de-certifi-
open area or any other open area. An
cation within 20 business days of the
OPO competing for an open service
hearing.
area must submit information and data
(1) Reversal of de-certification. If the
that describe the barriers in its service
hearing officer reverses CMS’ deter-
area, how they affected organ dona-
mination to de-certify an OPO in a case
tion, what steps the OPO took to over-
involving the involuntary termination
come them, and the results.
of the OPO’s agreement, CMS will not
(c) Criteria to compete. To compete for
terminate the OPO’s agreement and
an open service area, an OPO must
will not de-certify the OPO.
meet the criteria in paragraph (a) of
(2) De-certification is upheld. If the de- this section and the following addi-
certification determination is upheld tional criteria:
by the hearing officer, the OPO is de- (1) The OPO’s performance on the do-
certified and it has no further adminis- nation rate outcome measure and yield
trative appeal rights. outcome measure is at or above 100 per-
(j) Extension of agreement. If there is cent of the mean national rate aver-
insufficient time prior to expiration of aged over the 4 years of the re-certifi-
an agreement with CMS to allow for cation cycle; and
competition of the service area and, if (2) The OPO’s donation rate is at
necessary, transition of the service least 15 percentage points higher than
area to a successor OPO, CMS may the donation rate of the OPO currently
choose to extend the OPO’s agreement designated for the service area.
with CMS. (3) The OPO must compete for the en-
(k) Effects of de-certification. Medicare tire service area.
and Medicaid payments may not be (d) Criteria for selection. CMS will des-
made for organ procurement services ignate an OPO for an open service area
the OPO furnishes on or after the effec- based on the following criteria:
tive date of de-certification. CMS will (1) Performance on the outcome
then open the de-certified OPO’s serv- measures at § 486.318;
ice area for competition as set forth in (2) Relative success in meeting the
§ 486.316(c). process performance measures and
other conditions at §§ 486.320 through
§ 486.316 Re-certification and competi- 486.348;
tion processes.
(3) Contiguity to the open service
(a) Re-Certification of OPOs. An OPO area.
is re-certified for an additional 4 years (4) Success in identifying and over-
and its service area is not opened for coming barriers to donation within its
competition when the OPO: own service area and the relevance of
(1) Meets two out of the three out- those barriers to barriers in the open
come measures requirements at area. An OPO competing for an open
§ 486.318; and service area must submit information
254
and data that describe the barriers in (Observed per 100 donors—Expected per
its service area, how they affected 100 donors <¥10);
organ donation, what steps the OPO (B) A ratio of observed to expected
took to overcome them, and the re- yield less than 0.90; and
sults. (C) A two-sided p-value is less than
(e) No OPO applies. If no OPO applies 0.05.
to compete for a de-certified OPO’s (ii) The number of organs used for re-
open area, CMS may select a single search per donor, including pancreata
OPO to take over the entire open area used for islet cell research.
or may adjust the service area bound- (b) For OPOs operating exclusively in
aries of two or more contiguous OPOs noncontiguous States, Common-
to incorporate the open area. CMS will wealths, Territories, and possessions,
make its decision based on the criteria an OPO must meet two out of the three
in paragraph (d) of this section. following outcome measures:
(1) The OPO’s donation rate of eligi-
[71 FR 31046, May 31, 2006, as amended at 78 ble donors as a percentage of eligible
FR 75199, Dec. 10, 2013]
deaths is no more than 1.5 standard de-
ORGAN PROCUREMENT ORGANIZATION viations below the mean national dona-
OUTCOME REQUIREMENTS tion rate of eligible donors as a per-
centage of eligible deaths, averaged
§ 486.318 Condition: Outcome meas- over the 4 years of the re-certification
ures. cycle. Both the numerator and denomi-
nator of an individual OPO’s donation
(a) With the exception of OPOs oper- rate ratio are adjusted by adding a 1
ating exclusively in noncontiguous for each donation after cardiac death
States, Commonwealths, Territories, donor and each donor over the age of
or possessions, an OPO must meet two 70;
out of the three following outcome (2) The observed donation rate is not
measures: significantly lower than the expected
(1) The OPO’s donation rate of eligi- donation rate for 18 or more months of
ble donors as a percentage of eligible the 36 months of data used for re-cer-
deaths is no more than 1.5 standard de- tification, as calculated by the SRTR;
viations below the mean national dona- (3) The OPO data reports, averaged
tion rate of eligible donors as a per- over the 4 years of the recertification
centage of eligible deaths, averaged cycle, must meet the rules and require-
over the 4 years of the re-certification ments of the most current OPTN ag-
cycle. Both the numerator and denomi- gregate donor yield measure.
nator of an individual OPO’s donation (i) The initial criteria used to iden-
rate ratio are adjusted by adding a 1 tify OPOs with lower than expected
for each donation after cardiac death organ yield, for all organs as well as for
donor and each donor over the age of each organ type, will include all of the
70; following:
(2) The observed donation rate is not (A) More than 10 fewer observed or-
significantly lower than the expected gans per 100 donors than expected yield
donation rate for 18 or more months of (Observed per 100 donors—Expected per
the 36 months of data used for re-cer- 100 donors <¥10);
tification, as calculated by the SRTR; (B) A ratio of observed to expected
(3) The OPO data reports, averaged yield less than 0.90; and
over the 4 years of the recertification (C) A two-sided p-value is less than
cycle, must meet the rules and require- 0.05.
ments of the most current OPTN ag- (ii) The number of organs used for re-
gregate donor yield measure. search per donor, including pancreata
(i) The initial criteria used to iden- used for islet cell research.
tify OPOs with lower than expected (c) Data for the outcome measures.
organ yield, for all organs as well as for (1) An OPO’s performance on the out-
each organ type, will include all of the come measures is based on 36 months
following: of data, beginning with January 1 of

(A) More than 10 fewer observed or- the first full year of the re-certifi-
gans per 100 donors than expected yield cation cycle and ending 36 months
255
§ 486.320 42 CFR Ch. IV (10–1–17 Edition)
later on December 31, 7 months prior to protocol for donation after cardiac
the end of the re-certification cycle. death) and the requirements for hos-
(2) If an OPO takes over another pitals at § 482.45 or § 485.643. The agree-
OPO’s service area on a date later than ment must specify the meaning of the
January 1 of the first full year of the terms ‘‘timely referral’’ and ‘‘immi-
re-certification cycle so that 36 months nent death.’’
of data are not available to evaluate (b) Standard: Designated requestor
the OPO’s performance in its new serv- training for hospital staff. The OPO
ice area, we will not hold the OPO ac- must offer to provide designated re-
countable for its performance in the questor training on at least an annual
new area until the end of the following basis for hospital and critical access
re-certification cycle when 36 months hospital staff.
of data are available. (c) Standard: Cooperation with tissue
banks.
FR 75199, Dec. 10, 2013; 81 FR 79881, Nov. 14,
(1) The OPO must have arrangements
2016] to cooperate with tissue banks that
have agreements with hospitals and
ORGAN PROCUREMENT ORGANIZATION critical access hospitals with which the
PROCESS PERFORMANCE MEASURES OPO has agreements. The OPO must
cooperate in the following activities,
§ 486.320 Condition: Participation in as may be appropriate, to ensure that
Organ Procurement and Transplan- all usable tissues are obtained from po-
tation Network. tential donors:
After being designated, an OPO must (i) Screening and referral of potential
become a member of, participate in, tissue donors.
and abide by the rules and require- (ii) Obtaining informed consent from
ments of the OPTN established and op- families of potential tissue donors.
erated in accordance with section 372 of (iii) Retrieval, processing, preserva-
the Public Health Service Act (42 tion, storage, and distribution of tis-
U.S.C. 274). The term ‘‘rules and re- sues.
quirements of the OPTN’’ means those (iv) Providing designated requestor
rules and requirements approved by the training.
Secretary. No OPO is considered out of (2) An OPO is not required to have an
compliance with section 1138(b)(1)(D) of arrangement with a tissue bank that is
the Act or this section until the Sec- unwilling to have an arrangement with
retary approves a determination that the OPO.
the OPO failed to comply with the
rules and requirements of the OPTN. § 486.324 Condition: Administration
The Secretary may impose sanctions and governing body.
under section 1138 only after such non- (a) While an OPO may have more
compliance has been determined in this than one board, the OPO must have an
manner. advisory board that has both the au-
thority described in paragraph (b) of
§ 486.322 Condition: Relationships this section and the following member-
with hospitals, critical access hos- ship:
pitals, and tissue banks. (1) Members who represent hospital
(a) Standard: Hospital agreements. administrators, either intensive care or
An OPO must have a written agree- emergency room personnel, tissue
ment with 95 percent of the Medicare banks, and voluntary health associa-
and Medicaid participating hospitals tions in the OPO’s service area.
and critical access hospitals in its serv- (2) Individuals who represent the pub-
ice area that have both a ventilator lic residing in the OPO’s service area.
and an operating room and have not (3) A physician with knowledge, expe-
been granted a waiver by CMS to work rience, or skill in the field of human
with another OPO. The agreement histocompatibility, or an individual
must describe the responsibilities of with a doctorate degree in a biological
both the OPO and hospital or critical science and with knowledge, experi-
access hospital in regard to donation ence, or skills in the field of human
after cardiac death (if the OPO has a histocompatibility.
256
(4) A neurosurgeon or other physician making routine inquiries about organ

with knowledge or skills in the neuro- donations by potential donors.
sciences. (c) The advisory board described in
(5) A transplant surgeon representing paragraph (a) of this section has no au-
each transplant hospital in the service thority over any other activity of the
area with which the OPO has arrange- OPO and may not serve as the OPO’s
ments to coordinate its activities. The governing body or board of directors.
transplant surgeon must have prac- Members of the advisory board de-
ticing privileges and perform trans- scribed in paragraph (a) of this section
plants in the transplant hospital rep- are prohibited from serving on any
resented. other OPO board.
(6) An organ donor family member. (d) The OPO must have bylaws for
(b) The OPO board described in para- each of its board(s) that address poten-
graph (a) of this section has the au- tial conflicts of interest, length of
thority to recommend policies for the terms, and criteria for selecting and re-
following: moving members.
(1) Procurement of organs. (e) A governing body must have full
(2) Effective agreements to identify legal authority and responsibility for
potential organ donors with a substan- the management and provision of all
tial majority of hospitals in its service OPO services and must develop and
area that have facilities for organ do- oversee implementation of policies and
nation. procedures considered necessary for the
(3) Systematic efforts, including pro- effective administration of the OPO,
fessional education, to acquire all use- including fiscal operations, the OPO’s
able organs from potential donors. quality assessment and performance
(4) Arrangements for the acquisition improvement (QAPI) program, and
and preservation of donated organs and services furnished under contract or ar-
provision of quality standards for the rangement, including agreements for
acquisition of organs that are con- these services. The governing body
sistent with the standards adopted by must appoint an individual to be re-
the OPTN, including arranging for sponsible for the day-to-day operation
testing with respect to preventing the of the OPO.
acquisition of organs that are infected (f) The OPO must have procedures to
with the etiologic agent for acquired address potential conflicts of interest
immunodeficiency syndrome (AIDS). for the governing body described in
(5) Appropriate tissue typing of or- paragraph (d) of this section.
gans. (g) The OPO’s policies must state
(6) A system for allocation of organs whether the OPO recovers organs from
among transplant patients that is con- donors after cardiac death.
sistent with the rules and requirements [71 FR 31046, May 31, 2006, as amended at 77
of the OPTN, as defined in § 486.320 of FR 29031, May 16, 2012]
this part.
(7) Transportation of organs to trans- § 486.326 Condition: Human resources.
plant hospitals. All OPOs must have a sufficient num-
(8) Coordination of activities with ber of qualified staff, including a direc-
transplant hospitals in the OPO’s serv- tor, a medical director, organ procure-
ice area. ment coordinators, and hospital devel-
(9) Participation in the OPTN. opment staff to obtain all usable or-
(10) Arrangements to cooperate with gans from potential donors, and to en-
tissue banks for the retrieval, proc- sure that required services are provided
essing, preservation, storage, and dis- to families of potential donors, hos-
tribution of tissues as may be appro- pitals, tissue banks, and individuals
priate to assure that all useable tissues and facilities that use organs for re-
are obtained from potential donors. search.
(11) Annual evaluation of the effec- (a) Standard: Qualifications. (1) The
tiveness of the OPO in acquiring or- OPO must ensure that all individuals
gans. who provide services and/or supervise

(12) Assistance to hospitals in estab- services, including services furnished
lishing and implementing protocols for under contract or arrangement, are
257
§ 486.328 42 CFR Ch. IV (10–1–17 Edition)
qualified to provide or supervise the territories within the OPO’s service

services. area or as required by State or terri-
(2) The OPO must develop and imple- tory law or by the jurisdiction in which
ment a written policy that addresses the OPO is located. The medical direc-
potential conflicts of interest for the tor is responsible for implementation
OPO’s director, medical director, sen- of the OPO’s protocols for donor eval-
ior management, and procurement co- uation and management and organ re-
ordinators. covery and placement. The medical di-
(3) The OPO must have credentialing rector is responsible for oversight of
records for physicians and other practi- the clinical management of potential
tioners who routinely recover organs in donors, including providing assistance
hospitals under contract or arrange- in managing a donor case when the sur-
ment with the OPO and ensure that all geon on call is unavailable.
physicians and other practitioners who
recover organs in hospitals with which § 486.328 Condition: Reporting of data.
the OPO has agreements are qualified (a) An OPO must provide individ-
and trained. ually-identifiable, hospital-specific
(b) Standard: Staffing. (1) The OPO organ donation and transplantation
must provide sufficient coverage, ei- data and other information to the
ther by its own staff or under contract Organ Procurement and Transplan-
or arrangement, to assure both that tation Network, the Scientific Registry
hospital referral calls are screened for of Transplant Beneficiaries, and DHHS,
donor potential and that potential do- as requested by the Secretary. The
nors are evaluated for medical suit- data may include, but are not limited
ability for organ and/or tissue donation to:
in a timely manner. (1) Number of hospital deaths;
(2) The OPO must have a sufficient (2) Results of death record reviews;
number of qualified staff to provide in- (3) Number and timeliness of referral
formation and support to potential calls from hospitals;
organ donor families; request consent
(4) Number of eligible deaths;
for donation; ensure optimal mainte-
nance of the donor, efficient placement (5) Data related to non-recovery of
of organs, and adequate oversight of organs;
organ recovery; and conduct QAPI ac- (6) Data about consents for donation;
tivities, such as death record reviews (7) Number of eligible donors;
and hospital development. (8) Number of organs recovered, by
(3) The OPO must provide a sufficient type of organ; and
number of recovery personnel, either (9) Number of organs transplanted,
from its own staff or under contract or by type of organ.
arrangement, to ensure that all usable (b) An OPO must provide hospital-
organs are recovered in a manner that, specific organ donation data annually
to the extent possible, preserves them to the transplant hospitals with which
for transplantation. it has agreements.
(c) Standard: Education, training, and (c) Data to be used for OPO re-certifi-
performance evaluation. The OPO must cation purposes must be reported to
provide its staff with the education, the OPTN and must include data for all
training, and supervision necessary to deaths in all hospitals and critical ac-
furnish required services. Training cess hospitals in the OPO’s donation
must include but is not limited to per- service area, unless a hospital or crit-
formance expectations for staff, appli- ical access hospital has been granted a
cable organizational policies and proce- waiver to work with a different OPO.
dures, and QAPI activities. OPOs must (d) Data reported by the OPO to the
evaluate the performance of their OPTN must be reported within 30 days
staffs and provide training, as needed, after the end of the month in which a
to improve individual and overall staff death occurred. If an OPO determines
performance and effectiveness. through death record review or other
(d) Standard: Medical director. The means that the data it reported to the
OPO’s medical director is a physician OPTN was incorrect, it must report the
licensed in at least one of the States or corrected data to the OPTN within 30
258
days of the end of the month in which the purpose of transplantation, includ-
the error is identified. ing information identifying transplant
(e) For the purpose of determining beneficiaries.
the information to be collected under (c) Data retention. Donor and trans-
paragraph (a) of this section, the fol- plant beneficiary records must be
lowing definitions apply: maintained in a human readable and
(1) Kidneys procured. Each kidney re- reproducible paper or electronic format
covered will be counted individually. for 7 years.
En bloc kidneys recovered will count as (d) Format of records. The OPO must
two kidneys procured. maintain data in a format that can
(2) Kidneys transplanted. Each kidney readily be transferred to a successor
transplanted will be counted individ- OPO and in the event of a transfer
ually. En bloc kidney transplants will must provide to CMS copies of all
be counted as two kidneys trans- records, data, and software necessary
planted. to ensure uninterrupted service by a
(3) Extra-renal organs procured. Each successor OPO. Records and data sub-
organ recovered is counted individ- ject to this requirement include donor
ually. and transplant beneficiary records and
(4) Extra-renal organs transplanted. procedural manuals and other mate-
Each organ or part thereof trans- rials used in conducting OPO oper-
planted will be counted individually. ations.
For example, a single liver is counted
as one organ procured and each portion § 486.342 Condition: Requesting con-
that is transplanted will count as one sent.
transplant. Further, a heart and double An OPO must encourage discretion
lung transplant will be counted as and sensitivity with respect to the cir-
three organs transplanted. A kidney/ cumstances, views, and beliefs of po-
pancreas transplant will count as one tential donor families.
kidney transplanted and one extra- (a) An OPO must have a written pro-
renal organ transplanted. tocol to ensure that, in the absence of
a donor document, the individual(s) re-
§ 486.330 Condition: Information man- sponsible for making the donation de-
agement. cision are informed of their options to
An OPO must establish and use an donate organs or tissues (when the
electronic information management OPO is making a request for tissues) or
system to maintain the required med- to decline to donate. The OPO must
ical, social and identifying information provide to the individual(s) responsible
for every donor and transplant bene- for making the donation decision, at a
ficiary and develop and follow proce- minimum, the following:
dures to ensure the confidentiality and (1) A list of the organs and/or tissues
security of the information. that may be recovered.
(a) Donor information. The OPO must (2) The most likely uses for the do-
maintain a record for every donor. The nated organs or tissues.
record must include, at a minimum, in- (3) A description of the screening and
formation identifying the donor (for recovery processes.
example, name, address, date of birth, (4) Information about the organiza-
social security number or other unique tions that will recover, process, and
identifier, such as Medicare health in- distribute the tissue.
surance claim number), organs and (5) Information regarding access to
(when applicable) tissues recovered, and release of the donor’s medical
date of the organ recovery, donor man- records.
agement data, all test results, current (6) An explanation of the impact the
hospital history, past medical and so- donation process will have on burial ar-
cial history, the pronouncement of rangements and the appearance of the
death, and consent and next-of-kin in- donor’s body.
formation. (7) Contact information for indi-
(b) Disposition of organs. The OPO vidual(s) with questions or concerns.

must maintain records showing the dis- (8) A copy of the signed consent form
position of each organ recovered for if a donation is made.
259
§ 486.344 42 CFR Ch. IV (10–1–17 Edition)
(b) If an OPO does not request con- (2) Ensure that screening and testing
sent to donation because a potential of the potential donor (including point-
donor consented to donation before his of-care testing and blood typing) are
or her death in a manner that satisfied conducted by a laboratory that is cer-
applicable State law requirements in tified in the appropriate specialty or
the potential donor’s State of resi- subspecialty of service in accordance
dence, the OPO must provide informa- with part 493 of this chapter.
tion about the donation to the family (3) Ensure that the potential donor’s
of the potential donor, as requested. blood is typed using two separate blood
samples.
§ 486.344 Condition: Evaluation and (4) Document potential donor’s
management of potential donors record with all test results, including
and organ placement and recovery. blood type, before organ recovery.
The OPO must have written proto- (d) Standard: Collaboration with trans-
cols for donor evaluation and manage- plant programs. (1) The OPO must estab-
ment and organ placement and recov- lish protocols in collaboration with
ery that meet current standards of transplant programs that define the
practice and are designed to maximize roles and responsibilities of the OPO
organ quality and optimize the number and the transplant program for all ac-
of donors and the number of organs re- tivities associated with the evaluation
covered and transplanted per donor. and management of potential donors,
(a) Potential donor protocol manage- organ recovery, and organ placement,
ment. (1) The medical director is re- including donation after cardiac death,
sponsible for ensuring that potential if the OPO has implemented a protocol
donor evaluation and management pro- for donation after cardiac death.
tocols are implemented correctly and (2) The protocol must ensure that:
appropriately to ensure that potential (i) The OPO is responsible for two
donors are thoroughly assessed for separate determinations of the donor’s
medical suitability for organ donation blood type;
and clinically managed to optimize (ii) If the identity of the intended re-
organ viability and function. cipient is known, the OPO has a proce-
(2) The OPO must implement a sys- dure to ensure that prior to organ re-
tem that ensures that a qualified phy- covery, an individual from the OPO’s
sician or other qualified individual is staff compares the blood type of the
available to assist in the medical man- donor with the blood type of the in-
agement of a potential donor when the tended recipient, and the accuracy of
surgeon on call is unavailable. the comparison is verified by a dif-
(b) Potential donor evaluation. The ferent individual;
OPO must do the following: (iii) Documentation of the donor’s
(1) Verify that death has been pro- blood type accompanies the organ to
nounced according to applicable local, the hospital where the transplant will
State, and Federal laws. take place.
(2) Determine whether there are con- (3) The established protocols must be
ditions that may influence donor ac- reviewed regularly with the transplant
ceptance. programs to incorporate practices that
(3) If possible, obtain the potential have been shown to maximize organ do-
donor’s medical and social history. nation and transplantation.
(4) Review the potential donor’s med- (e) Documentation of beneficiary infor-
ical chart and perform a physical ex- mation. If the intended beneficiary has
amination of the donor. been identified prior to recovery of an
(5) Obtain the potential donor’s vital organ for transplantation, the OPO
signs and perform all pertinent tests. must have written documentation from
(c) Testing. The OPO must do the fol- the OPTN showing, at a minimum, the
lowing: intended organ beneficiary’s ranking in
(1) Arrange for screening and testing relation to other suitable candidates
of the potential donor for infectious and the recipient’s OPTN identification
disease according to current standards number and blood type.

of practice, including testing for the (f) Donation after cardiac death. If an
human immunodeficiency virus. OPO recovers organs from donors after
260
cardiac death, the OPO must have pro- (iii) Infectious disease testing results
tocols that address the following: available at the time of organ pack-
(1) Criteria for evaluating patients aging.
for donation after cardiac death; (3) The source documentation must
(2) Withdrawal of support, including be placed in a watertight container in
the relationship between the time of either of the following:
consent to donation and the with- (i) A location specifically designed
drawal of support; for documentation; or
(3) Use of medications and interven- (ii) Between the inner and external
tions not related to withdrawal of sup- transport materials.
port; (4) Two individuals, one of whom
(4) Involvement of family members must be an OPO employee, must verify
prior to organ recovery; that the documentation that accom-
(5) Criteria for declaration of death panies an organ to a transplant center
and the time period that must elapse is correct.
prior to organ recovery. (c) The OPO must develop and follow
(g) Organ allocation. The OPO must a written protocol for packaging, label-
have a system to allocate donated or- ing, handling, and shipping organs in a
gans among transplant patients that is manner that ensures their arrival with-
consistent with the rules and require- out compromise to the quality of the
ments of the OPTN, as defined in organ. The protocol must include pro-
§ 486.320 of this part. cedures to check the accuracy and in-
(h) Organ placement. The OPO must tegrity of labels, packaging, and con-
develop and implement a protocol to tents prior to transport, including
maximize placement of organs for verification by two individuals, one of
transplantation. whom must be an OPO employee, that
information listed on the labels is cor-
FR 27156, May 12, 2014] rect.
(d) All packaging in which an organ
§ 486.346 Condition: Organ prepara- is transported must be marked with
tion and transport. the identification number, specific con-
(a) The OPO must arrange for testing tents, and donor’s blood type.
of organs for infectious disease and tis- [71 FR 31046, May 31, 2006, as amended at 81
sue typing of organs according to cur- FR 79881, Nov. 14, 2016]
rent standards of practice. The OPO
must ensure that testing and tissue § 486.348 Condition: Quality assess-
typing of organs are conducted by a ment and performance improve-
laboratory that is certified in the ap- ment (QAPI).
propriate specialty or subspecialty of The OPO must develop, implement,
service in accordance with part 493 of and maintain a comprehensive, data-
this chapter. driven QAPI program designed to mon-
(b)(1) The OPO must send complete itor and evaluate performance of all
documentation of donor information to donation services, including services
the transplant center with the organ, provided under contract or arrange-
including donor evaluation, the comment.
plete record of the donor’s manage- (a) Standard: Components of a QAPI
ment, documentation of consent, docu- program. The OPO’s QAPI program
mentation of the pronouncement of must include objective measures to
death, and documentation for deter- evaluate and demonstrate improved
mining organ quality. This information performance with regard to OPO activi-
is available to the transplant center ties, such as hospital development, des-
electronically. ignated requestor training, donor man-
(2) The OPO must physically send a agement, timeliness of on-site response
paper copy of the following documenta- to hospital referrals, consent practices,
tion with each organ: organ recovery and placement, and
(i) Blood type; organ packaging and transport. The

(ii) Blood subtype, if used for alloca- OPO must take actions that result in
tion; and performance improvements and track
261
§ 486.360 42 CFR Ch. IV (10–1–17 Edition)
performance to ensure that improve- egations of authority and succession

ments are sustained. plans.
(b) Standard: Death record reviews. As (4) Include a process for cooperation
part of its ongoing QAPI efforts, an and collaboration with local, tribal, re-
OPO must conduct at least monthly gional, State, and Federal emergency
death record reviews in every Medicare preparedness officials’ efforts to main-
and Medicaid participating hospital in tain an integrated response during a
its service area that has a Level I or disaster or emergency situation, in-
Level II trauma center or 150 or more cluding documentation of the OPO’s ef-
beds, a ventilator, and an intensive forts to contact such officials and,
care unit (unless the hospital has a when applicable, of its participation in
waiver to work with another OPO), collaborative and cooperative planning
with the exception of psychiatric and efforts.
rehabilitation hospitals. When missed (b) Policies and procedures. The OPO
opportunities for donation are identi- must develop and implement emer-
fied, the OPO must implement actions gency preparedness policies and proce-
to improve performance. dures, based on the emergency plan set
(c) Standard: Adverse events. (1) An forth in paragraph (a) of this section,
OPO must establish written policies to risk assessment at paragraph (a)(1) of
address, at a minimum, the process for this section, and, the communication
identification, reporting, analysis, and plan at paragraph (c) of this section.
prevention of adverse events that occur The policies and procedures must be re-
during the organ donation process. viewed and updated at least annually.
(2) The OPO must conduct a thorough At a minimum, the policies and proce-
analysis of any adverse event and must dures must address the following:
use the analysis to affect changes in (1) A system to track the location of
the OPO’s policies and practices to pre- on-duty staff during and after an emer-
vent repeat incidents. gency. If on-duty staff is relocated dur-
ing the emergency, the OPO must doc-
§ 486.360 Condition for Coverage: ument the specific name and location
Emergency preparedness. of the receiving facility or other loca-
The Organ Procurement Organization tion.
(OPO) must comply with all applicable (2) A system of medical documenta-
Federal, State, and local emergency tion that preserves potential and ac-
preparedness requirements. The OPO tual donor information, protects con-
must establish and maintain an emer- fidentiality of potential and actual
gency preparedness program that donor information, and secures and
meets the requirements of this section. maintains the availability of records.
The emergency preparedness program (c) Communication plan. The OPO
must include, but not be limited to, the must develop and maintain an emer-
following elements: gency preparedness communication
(a) Emergency plan. The OPO must de- plan that complies with Federal, State,
velop and maintain an emergency pre- and local laws and must be reviewed
paredness plan that must be reviewed and updated at least annually. The
and updated at least annually. The communication plan must include all
plan must do all of the following: of the following:
(1) Be based on and include a docu- (1) Names and contact information
mented, facility-based and community- for the following:
based risk assessment, utilizing an all- (i) Staff.
hazards approach. (ii) Entities providing services under
(2) Include strategies for addressing arrangement.
emergency events identified by the (iii) Volunteers.
risk assessment. (iv) Other OPOs.
(3) Address the type of hospitals with (v) Transplant and donor hospitals in
which the OPO has agreements; the the OPO’s Donation Service Area
type of services the OPO has the capac- (DSA).

ity to provide in an emergency; and (2) Contact information for the fol-
continuity of operations, including del- lowing:
262
(i) Federal, State, tribal, regional, mutually agreed upon protocols that
and local emergency preparedness address the duties and responsibilities
staff. of the transplant program, the hospital
(ii) Other sources of assistance. in which the transplant program is op-
(3) Primary and alternate means for erated, and the OPO during an emer-
communicating with the following: gency.
(i) OPO’s staff. (2) The OPO must have the capability
(ii) Federal, State, tribal, regional, to continue its operation from an alter-
and local emergency management nate location during an emergency.
agencies. The OPO could either have:
(d) Training and testing. The OPO (i) An agreement with one or more
must develop and maintain an emer- other OPOs to provide essential organ
gency preparedness training and test- procurement services to all or a por-
ing program that is based on the emer- tion of its DSA in the event the OPO
gency plan set forth in paragraph (a) of cannot provide those services during an
this section, risk assessment at para- emergency;
graph (a)(1) of this section, policies and (ii) If the OPO has more than one lo-
procedures at paragraph (b) of this sec- cation, an alternate location from
tion, and the communication plan at which the OPO could conduct its oper-
paragraph (c) of this section. The train- ation; or
ing and testing program must be re-
(iii) A plan to relocate to another lo-
cation as part of its emergency plan as
(1) Training. The OPO must do all of
required by paragraph (a) of this sec-
the following:
tion.
(i) Initial training in emergency pre-
paredness policies and procedures to all (f) Integrated healthcare systems. If an
new and existing staff, individuals pro- OPO is part of a healthcare system
viding services under arrangement, and consisting of multiple separately cer-
volunteers, consistent with their ex- tified healthcare facilities that elects
pected roles. to have a unified and integrated emer-
(ii) Provide emergency preparedness gency preparedness program, the OPO
training at least annually. may choose to participate in the
(iii) Maintain documentation of the healthcare system’s coordinated emer-
training. gency preparedness program. If elected,
(iv) Demonstrate staff knowledge of the unified and integrated emergency
emergency procedures. preparedness program must do all of
(2) Testing. The OPO must conduct the following:
exercises to test the emergency plan. (1) Demonstrate that each separately
The OPO must do the following: certified facility within the system ac-
(i) Conduct a paper-based, tabletop tively participated in the development
exercise at least annually. A tabletop of the unified and integrated emer-
exercise is a group discussion led by a gency preparedness program.
facilitator, using a narrated, clinically- (2) Be developed and maintained in a
relevant emergency scenario, and a set manner that takes into account each
of problem statements, directed mes- separately certified facility’s unique
sages, or prepared questions designed circumstances, patient populations,
to challenge an emergency plan. and services offered.
(ii) Analyze the OPO’s response to (3) Demonstrate that each separately
and maintain documentation of all ta- certified facility is capable of actively
bletop exercises, and emergency using the unified and integrated emer-
events, and revise the OPO’s emergency preparedness program and is in
gency plan, as needed. compliance.
(e) Continuity of OPO operations dur- (4) Include a unified and integrated
ing an emergency. Each OPO must have emergency plan that meets the require-
a plan to continue operations during an ments of paragraphs (a)(2), (3), and (4)
emergency. of this section. The unified and inte-
(1) The OPO must develop and main- grated emergency plan must also be
tain in the protocols with transplant based on and include all of the fol-
programs required under § 486.344(d), lowing:
263
(i) A documented community-based 488.54 Temporary waivers applicable to hos-

risk assessment, utilizing an all-haz- pitals.
ards approach. 488.56 Temporary waivers applicable to
(ii) A documented individual facility- skilled nursing facilities.
based risk assessment for each sepa- 488.60 Special procedures for approving end
rately certified facility within the stage renal disease facilities.
health system, utilizing an all-hazards 488.61 Special procedures for approval and
re-approval of organ transplant centers.
approach.
488.64 Remote facility variances for utiliza-
(5) Include integrated policies and
tion review requirements.
procedures that meet the requirements
488.68 State Agency responsibilities for
set forth in paragraph (b) of this sec- OASIS collection and data base require-
tion, a coordinated communication ments.
plan and training and testing programs
that meet the requirements of para- Subpart C—Survey Forms and Procedures
graphs (c) and (d) of this section, re-
spectively. 488.100 Long term care survey forms, Part
A.
[81 FR 64040, Sept. 16, 2016] 488.105 Long term care survey forms, Part
B.
488.110 Procedural guidelines.
PART 488—SURVEY, CERTIFI- 488.115 Care guidelines.
CATION, AND ENFORCEMENT
PROCEDURES Subpart D—Reconsideration of Adverse
Determinations—Deeming Authority for
Subpart A—General Provisions Accreditation Organizations and CLIA
Exemption of Laboratories Under State
Sec. Programs
488.1 Definitions.
488.2 Statutory basis. 488.201 Reconsideration.
488.3 Conditions of participation, conditions 488.203 Withdrawal of request for reconsid-
for coverage, conditions for certification eration.
and long term care requirements. 488.205 Right to informal hearing.
488.4 General rules for a CMS-approved ac- 488.207 Informal hearing procedures.
creditation program for providers and
488.209 Hearing officer’s findings.
suppliers.
488.5 Application and re-application proce- 488.211 Final reconsideration determina-
dures for national accrediting organization.
tions.
488.6 Providers or suppliers that participate Subpart E—Survey and Certification of
in the Medicaid program under a CMS- Long-Term Care Facilities
approved accreditation program.
488.7 Release and use of accreditation sur- 488.300 Statutory basis.
veys. 488.301 Definitions.
488.8 Ongoing review of accrediting organi- 488.303 State plan requirement.
zations. 488.305 Standard surveys.
488.9 Validation surveys. 488.307 Unannounced surveys.
488.10 State survey agency review: Statu- 488.308 Survey frequency.
tory provisions. 488.310 Extended survey.
488.11 State survey agency functions. 488.312 Consistency of survey results.
488.12 Effect of survey agency certification.
488.314 Survey teams.
488.13 Loss of accreditation.
488.14 Effect of QIO review. 488.318 Inadequate survey performance.
488.18 Documentation of findings. 488.320 Sanctions for inadequate survey per-
488.20 Periodic review of compliance and ap- formance.
proval. 488.325 Disclosure of results of surveys and
488.24 Certification of noncompliance. activities.
488.26 Determining compliance. 488.330 Certification of compliance or non-
488.28 Providers or suppliers, other than compliance.
SNFs, NFs, and HHAs with deficiencies. 488.331 Informal dispute resolution.
488.30 Revisit user fee for revisit surveys. 488.332 Investigation of complaints of viola-
tions and monitoring of compliance.

Subpart B—Special Requirements 488.334 Educational programs.
488.52 [Reserved]
264
488.335 Action on complaints of resident ne- Subpart G [Reserved]
glect and abuse, and misappropriation of
resident property. Subpart H—Termination of Medicare Cov-
erage and Alternative Sanctions for
Subpart F—Enforcement of Compliance End-Stage Renal Disease (ESRD) Facili-
For Long-Term Care Facilities with Defi- ties
ciencies
488.604 Termination of Medicare coverage.
488.400 Statutory basis. 488.606 Alternative sanctions.
488.401 Definitions. 488.608 Notice of alternative sanction and
488.402 General provisions. appeal rights: Termination of coverage.
488.404 Factors to be considered in selecting 488.610 Notice of appeal rights: Alternative
remedies. sanctions.
488.406 Available remedies.
488.408 Selection of remedies. Subpart I—Survey and Certification of
488.410 Action when there is immediate Home Health Agencies
jeopardy.
488.412 Action when there is no immediate
488.705 Definitions.
jeopardy.
488.710 Standard surveys.
488.414 Action when there is repeated sub- 488.715 Partial extended surveys.
standard quality of care. 488.720 Extended surveys.
488.415 Temporary management. 488.725 Unannounced surveys.
488.417 Denial of payment for all new admis- 488.730 Survey frequency and content.
sions. 488.735 Surveyor qualifications.
488.418 Secretarial authority to deny all 488.740 Certification of compliance or non-
payments. compliance.
488.422 State monitoring. 488.745 Informal Dispute Resolution (IDR).
488.424 Directed plan of correction.
488.425 Directed inservice training. Subpart J—Alternative Sanctions for Home
488.426 Transfer of residents, or closure of Health Agencies With Deficiencies
the facility and transfer of residents.
488.430 Civil money penalties: Basis for im- 488.800 Statutory basis.
posing penalty. 488.805 Definitions.
488.431 Civil money penalties imposed by 488.810 General provisions.
CMS and independent informal dispute 488.815 Factors to be considered in selecting
resolution: for SNFS, dually-partici- sanctions.
488.820 Available sanctions.
pating SNF/NFs, and NF-only facilities.
488.825 Action when deficiencies pose imme-
488.432 Civil money penalties imposed by
diate jeopardy.
the State: NF-only.
488.830 Action when deficiencies are at the
488.433 Civil money penalties: Uses and ap- condition-level but do not pose imme-
proval of civil money penalties imposed diate jeopardy.
by CMS. 488.835 Temporary management.
488.434 Civil money penalties: Notice of pen- 488.840 Suspension of payment for all new
alty. patient admissions.
488.436 Civil money penalties: Waiver of 488.845 Civil money penalties.
hearing, reduction of penalty amount. 488.850 Directed plan of correction.
488.438 Civil money penalties: Amount of 488.855 Directed in-service training.
penalty. 488.860 Continuation of payments to an
488.440 Civil money penalties: Effective date HHA with deficiencies.
and duration of penalty. 488.865 Termination of provider agreement.
488.442 Civil money penalties: Due date for
AUTHORITY: Secs. 1102, 1128l, 1864, 1865, 1871
payment of penalty.
and 1875 of the Social Security Act, unless
488.444 Civil money penalties: Settlement of
otherwise noted (42 U.S.C 1302, 1320a–7j,
penalties.
1395aa, 1395bb, 1395hh and 1395ll).
488.446 Administrator sanctions: long-term
care facility closures. SOURCE: 53 FR 22859, June 17, 1988, unless
488.450 Continuation of payments to a facil- otherwise noted.
ity with deficiencies.
488.452 State and Federal disagreements in- Subpart A—General Provisions
volving findings not in agreement in non-
State operated NFs and dually partici- § 488.1 Definitions.
pating facilities when there is no imme-
diate jeopardy. As used in this part—

488.454 Duration of remedies. Act means the Social Security Act.
488.456 Termination of provider agreement. Certification means a determination
made by the state survey agency that
265
§ 488.1 42 CFR Ch. IV (10–1–17 Edition)
providers and suppliers are in compli- Provider of services or provider refers

ance with the applicable conditions of to a hospital, critical access hospital,
participation, conditions for coverage, skilled nursing facility, nursing facil-
conditions for certification, or require- ity, home health agency, hospice, com-
ments. prehensive outpatient rehabilitation
Conditions for certification means the facility, or a clinic, rehabilitation
health and safety standards RHCs must agency or public health agency that
meet to participate in the Medicare furnishes outpatient physical therapy
program. or speech pathology services.
Conditions for coverage means the re- Rate of disparity means the percent-
quirements suppliers must meet to par-
age of all sample validation surveys for
ticipate in the Medicare program.
which a State survey agency finds non-
Conditions of participation means the
requirements providers other than compliance with one or more Medicare
skilled nursing facilities must meet to conditions and no comparable condi-
participate in the Medicare program tion level deficiency was cited by the
and includes conditions of certification accreditation organization, where it is
for rural health clinics. reasonable to conclude that the defi-
Deemed status means that CMS has ciencies were present at the time of the
certified a provider or supplier for accreditation organization’s most re-
Medicare participation, based on all of cent surveys of providers or suppliers
the following criteria having been met: of the same type.
The provider or supplier has volun-
Example: Assume that during a validation
tarily applied for, and received, accred- review period State survey agencies perform
itation from a CMS-approved national validation surveys at 200 facilities of the
accrediting organization under the ap- same type (for example, ambulatory surgical
plicable Medicare accreditation pro- centers, home health agencies) accredited by
gram; the accrediting organization has the same accreditation organization. The
recommended the provider or supplier State survey agencies find 60 of the facilities
to CMS for Medicare participation; out of compliance with one or more Medicare
CMS has accepted the accrediting orga- conditions, and it is reasonable to conclude
nization’s recommendation; and CMS that these deficiencies were present at the
finds that all other participation re- time of the most recent survey by an accred-
quirements have been met. itation organization. The accreditation orga-
Full review means a survey of a pro- nization, however, has found deficiencies
comparable to the condition level defi-
vider or supplier for compliance with
ciencies at only 22 of the 60 facilities. These
all of the Medicare conditions or re-
validation results would yield ((60–22)/200) a
quirements applicable to that provider rate of disparity of 19 percent.
or supplier type.
Immediate jeopardy means a situation Reasonable assurance means that an
in which the provider’s or supplier’s accrediting organization has dem-
non-compliance with one or more onstrated to CMS’s satisfaction that
Medicare requirements, conditions of its accreditation program require-
participation, conditions for coverage ments meet or exceed the Medicare
or certification has caused, or is likely program requirements.
to cause, serious injury, harm, impair- State includes the District of Colum-
ment, or death to a resident or patient. bia, the Commonwealth of Puerto Rico,
Medicare condition means any condi- the Virgin Islands, Guam, and Amer-
tion of participation or for coverage, ican Samoa.
including any long term care require-
State survey agency refers to the state
ments.
health agency or other appropriate
National accrediting organization
state or local agency CMS uses to per-
means an organization that accredits
provider entities, as that term is de- form survey and review functions pro-
fined in section 1865(a)(4) of the Act, vided for in sections 1864, 1819(g), and
under a specific program and whose ac- 1919(g) of the Act.
credited provider entities under each Substantial allegation of non-compli-

program are widely located geographi- ance means a complaint from any of a
cally across the United States.
266
variety of sources (such as patient, rel- 1861(ee)—Discharge planning guidelines for

ative, or third party), including com- hospitals.
plaints submitted in person, by tele- 1861(ff)(3)(A)—Requirements for CMHCs.
1861(ss)(2)—Accreditation of religious non-
phone, through written correspond-
medical health care institutions.
ence, or in newspaper or magazine arti- 1863—Consultation with state agencies, ac-
cles, that would, if found to be present, crediting bodies, and other organizations
adversely affect the health and safety to develop conditions of participation, con-
of patients or residents and raises ditions for coverage, conditions for certifi-
doubts as to a provider’s or supplier’s cation, and requirements for providers or
compliance with any Medicare condi- suppliers.
tion of participation, condition for cov- 1864—Use of State survey agencies.
erage, condition for certification, or re- 1865—Effect of accreditation.
1875(b)—Requirements for performance re-
quirements. view of CMS-approved accreditation pro-
Supplier means any of the following: grams.
Independent laboratory; portable X-ray 1880—Requirements for hospitals and SNFs
services; physical therapist in inde- of the Indian Health Service.
pendent practice; ESRD facility; rural 1881—Requirements for ESRD facilities.
health clinic; Federally qualified 1883—Requirements for hospitals that fur-
health center; chiropractor; or ambula- nish extended care services.
tory surgical center. 1891—Conditions of participation for home
health agencies; home health quality.
[53 FR 22859, June 17, 1988, as amended at 54 1902—Requirements for participation in the
FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, Medicaid program.
1991; 57 FR 24982, June 12, 1992; 58 FR 30676, 1913—Medicaid requirements for hospitals
May 26, 1993; 58 FR 61838, Nov. 23, 1993; 62 FR that provide NF care.
46037, Aug. 29, 1997; 71 FR 68230, Nov. 24, 2006; 1919—Medicaid requirements for NFs.
80 FR 29834, May 22, 2015]
§ 488.2 Statutory basis. FR 67052, Nov. 30, 1999; 77 FR 67164, Nov. 8,
2012; 80 FR 29834, May 22, 2015]
This part is based on the indicated
provisions of the following sections of § 488.3 Conditions of participation,
the Act: conditions for coverage, conditions
for certification and long term care
1128—Exclusion of entities from participa- requirements.
tion in Medicare.
1128A—Civil money penalties. (a) Basic rules. To be approved for
1138(b)—Requirements for organ procure- participation in, or coverage under, the
ment organizations and organ procurement Medicare program, a prospective pro-
agencies. vider or supplier must meet the fol-
1814—Conditions for, and limitations on, pay- lowing:
ment for Part A services. (1) Meet the applicable statutory
1819—Requirements for SNFs.
1820—Requirements for CAHs. definitions in section 1138(b), 1819, 1820,
1832(a)(2)(C)—Requirements for Organiza- 1832(a)(2)(C), 1832(a)(2)(F), 1832(a)(2)(J),
tions that provide outpatient physical 1834(e), 1861, 1881, 1883, 1891, 1913 or 1919
therapy and speech language pathology of the Act.
services. (2) Be in compliance with the appli-
1832(a)(2)(F)—Requirements for ASCs. cable conditions, certification require-
1832(a)(2)(J)—Requirements for partial hos- ments, or long term care requirements
pitalization services provided by CMHCs.
prescribed in part 405 subparts U or X,
1861(e)—Requirements for hospitals.
1861(f)—Requirements for psychiatric hos- part 410 subpart E, part 416, part 418
pitals. subpart C, parts 482 through 486, part
1861(m)—Requirements for Home Health 491 subpart A, or part 494 of this chap-
Services ter.
1861(o)—Requirements for Home Health (b) Special conditions. The Secretary
Agencies shall consult with state agencies and
1861(p)(4)—Requirements for rehabilitation national AOs, as applicable, to develop
agencies.
CoP, CfC, conditions for certification
1861(z)—Institutional planning standards
and long term care requirements.
that hospitals and SNFs must meet.

1861(aa)—Requirements for RHCs and FQHCs. (1) The Secretary may, at a state’s
1861(cc)(2)—Requirements for CORFs. request, approve health and safety re-
1861(dd)—Requirements for hospices. quirements for providers or suppliers in
267
§ 488.4 42 CFR Ch. IV (10–1–17 Edition)
the state that exceed Medicare pro- program provides reasonable assurance
gram requirements. that the entities accredited under the
(2) If a state or political subdivision program meet or exceed the applicable
imposes requirements on institutions Medicare conditions or requirements.
(that exceed the Medicare program re- This information must include the fol-
quirements) as a condition for the pur- lowing:
chase of health services under a state (1) Documentation that demonstrates
Medicaid plan approved under title XIX the organization meets the definition
of the Act, (or if Guam, Puerto Rico, or of a ‘‘national accrediting organiza-
the Virgin Islands does so under a state tion’’ under § 488.1 as it relates to the
plan for Old Age Assistance under title accreditation program.
I of the Act, or for Aid to the Aged, (2) The type of provider or supplier
Blind, and Disabled under the original accreditation program for which the
title XVI of the Act), the Secretary im-
organization is requesting approval or
poses similar requirements as a condi-
re-approval.
tion for payment under Medicare in
that state or political subdivision. (3) A detailed crosswalk (in table for-
mat) that identifies, for each of the ap-
[80 FR 29835, May 22, 2015] plicable Medicare conditions or re-
quirements, the exact language of the
§ 488.4 General rules for a CMS-ap-
proved accreditation program for organization’s comparable accredita-
providers and suppliers. tion requirements and standards.
(4) A detailed description of the orga-
(a) The following requirements apply
nization’s survey process to confirm
when a national accrediting organiza-
that a provider or supplier meets or ex-
tion has applied for CMS approval of a
ceeds the Medicare program require-
provider or supplier accreditation pro-
gram and CMS has found that the pro- ments. This description must include
gram provides reasonable assurance for all of the following information:
providers or suppliers accredited under (i) Frequency of surveys performed
the program: and an agreement by the organization
(1) When a provider or supplier dem- to re-survey every accredited provider
onstrates full compliance with all of or supplier, through unannounced sur-
the accreditation program require- veys, no later than 36 months after the
ments of the accrediting organization’s prior accreditation effective date, in-
CMS-approved accreditation program, cluding an explanation of how the ac-
the accrediting organization may rec- crediting organization will maintain
ommend that CMS grant deemed status the schedule it proposes. If there is a
to the provider or supplier. statutorily-mandated survey interval
(2) CMS may deem the provider or of less than 36 months, the organiza-
supplier, excluding kidney transplant tion must indicate how it will adhere
centers within a hospital and ESRD fa- to the statutory schedule.
cilities, to be in compliance with the (ii) Documentation demonstrating
applicable Medicare conditions or re- the comparability of the organization’s
quirements. The deemed status pro- survey process and surveyor guidance
vider or supplier is subject to valida- to those required for state survey agen-
tion surveys as provided at § 488.9. cies conducting federal Medicare sur-
(b) [Reserved] veys for the same provider or supplier
[80 FR 29835, May 22, 2015] type, in accordance with the applicable
requirements or conditions of partici-
§ 488.5 Application and re-application pation or conditions for coverage or
procedures for national accrediting certification.
organizations. (iii) Copies of the organization’s sur-
(a) Information submitted with applica- vey forms, guidelines, and instructions
tion. A national accrediting organiza- to surveyors.
tion applying to CMS for approval or (iv) Documentation demonstrating
re-approval of an accreditation pro- that the organization’s survey reports
gram under § 488.4 must furnish CMS identify, for each finding of non-com-
with all of the following information pliance with accreditation standards,
and materials to demonstrate that the the comparable Medicare CoP, CfC,
268
conditions for certification, or require- creditation intervals for existing ac-

ments. credited facilities.
(v) Description of the organization’s (7) A description of the education and
accreditation survey review process. experience requirements surveyors
(vi) Description of the organization’s must meet.
procedures and timelines for notifying (8) A description of the content and
surveyed facilities of non-compliance frequency of the organization’s in-serv-
with the accreditation program’s ice training it provides to survey per-
standards. sonnel.
(vii) Description of the organization’s
(9) A description of the organization’s
procedures and timelines for moni-
evaluation systems used to monitor
toring the provider’s or supplier’s cor-
the performance of individual sur-
rection of identified non-compliance
with the accreditation program’s veyors and survey teams.
standards. (10) The organization’s policies and
(viii) A statement acknowledging procedures to avoid conflicts of inter-
that, as a condition for CMS approval est, including the appearance of con-
of a national accrediting organization’s flicts of interest, involving individuals
accreditation program, the organiza- who conduct surveys or participate in
tion agrees to provide CMS with infor- accreditation decisions.
mation extracted from each accredita- (11) A description of the organiza-
tion survey for a specified provider or tion’s data management and analysis
supplier as part of its data submissions system for its surveys and accredita-
required under paragraph (a)(11)(ii) of tion decisions, including all of the fol-
this section, a copy of all survey re- lowing:
ports and related information for appli- (i) A detailed description of how the
cants seeking initial participation in organization uses its data to assure the
Medicare, and, upon request from CMS, compliance of its accreditation pro-
a copy of the most recent accreditation gram with the Medicare program re-
survey for a specified provider or sup- quirements.
plier, together with any other informa- (ii) A statement acknowledging that
tion related to the survey as CMS may the organization agrees to submit
require (including corrective action timely, accurate, and complete data to
plans). support CMS’s evaluation of the ac-
(ix) A statement acknowledging that crediting organization’s performance.
the accrediting organization will pro- Data to be submitted includes, but is
vide timely notification to CMS when not limited to, accredited provider or
an accreditation survey or complaint supplier identifying information, sur-
investigation identifies an immediate vey schedules, survey findings, and no-
jeopardy as that term is defined at
tices of accreditation decisions. The or-
§ 489.3 of this chapter. Using the format
ganization must submit necessary data
specified by CMS, the accrediting orga-
according to the instructions and time-
nization must notify CMS within two
frames CMS specifies.
business days from the date the accred-
iting organization identifies the imme- (12) The organization’s procedures for
diate jeopardy. responding to, and investigating, com-
(5) The criteria for determining the plaints against accredited facilities, in-
size and composition of the organiza- cluding policies and procedures regard-
tion’s survey teams for the type of pro- ing referrals when applicable to appro-
vider or supplier to be accredited, in- priate licensing bodies and ombudsman
cluding variations in team size and programs.
composition for individual provider or (13) The organization’s accreditation
supplier surveys. status decision-making process, includ-
(6) The overall adequacy of the num- ing its policies and procedures for
ber of the organization’s surveyors, in- granting, withholding, or removing ac-
cluding how the organization will in- creditation status for facilities that
crease the size of the survey staff to fail to meet the accrediting organiza-
match growth in the number of accred- tion’s standards or requirements, as-
ited facilities while maintaining re-ac- signment of less than full accreditation
269
§ 488.5 42 CFR Ch. IV (10–1–17 Edition)
status or other actions taken by the or- the proposed changes without prior
ganization in response to non-compli- written notice of continued program
ance with its standards and require- approval from CMS except as provided
ments. The organization must furnish for at § 488.8(b)(2).
the following: (19) A statement that, in response to
(i) A description of all types and cat- a written notice from CMS to the orga-
egories of accreditation decisions asso- nization of a change in the applicable
ciated with the program for which ap- conditions or requirements or in the
proval is sought, including the dura- survey process, the organization will
tion of each. provide CMS with proposed cor-
(ii) A statement acknowledging that
responding changes in the organiza-
the organization agrees to notify CMS
tion’s requirements for its CMS-ap-
(in a manner CMS specifies) of any de-
cision to revoke, withdraw, or revise proved accreditation program to ensure
the accreditation status of a specific continued comparability with the CMS
deemed status provider or supplier, conditions or requirements or survey
within three business days from the process. The organization must comply
date the organization takes an action. with the following requirements:
(14) A list of all facilities currently (i) The proposed changes must be
accredited by the organization under submitted within 30 calendar days of
the program for which CMS approval is the date of the written CMS notice to
sought, including the type and cat- the organization or by a date specified
egory of accreditation currently held in the notice, whichever is later. CMS
by each provider or supplier, and the will give due consideration to an orga-
expiration date of each provider’s or nization’s request for an extension of
supplier’s current accreditation. the deadline.
(15) A schedule of all surveys ex- (ii) The proposed changes will not be
pected to be conducted by the organiza- implemented without prior written no-
tion for the accreditation program tice of continued program approval
under review during the 6-month period from CMS, except as provided for at
following submission of the applica- § 488.8(b)(1)(iv).
tion.
(20) A statement acknowledging that,
(16) The three most recent audited fi-
nancial statements of the organization as a condition for CMS’s approval of an
that demonstrate that the organiza- accreditation program, the organiza-
tion’s staffing, funding, and other re- tion will agree to permit its surveyors
sources are adequate to perform the re- to serve as witnesses in a legal pro-
quired surveys and related activities. ceeding if CMS takes an adverse action
(17) A statement that it will: against a provider or supplier on the
(i) Provide written notification to basis of the organization’s accredita-
CMS and to all providers or suppliers tion survey findings, and will cooperate
accredited under a CMS-approved ac- with CMS to make surveyors and other
creditation program at least 90 cal- staff available when needed.
endar days in advance of the effective (21) A statement acknowledging that
date of a decision by the organization the organization agrees to make all
to voluntarily terminate its CMS-ap- Medicare cited deficiencies, both stand-
proved accreditation program, includ- ard and condition level, immediate
ing the implications for their deemed jeopardy situations, and dates of cor-
status in accordance with § 488.8(g)(2); rection, for final accreditation survey
and reports publicly available on the orga-
(ii) Adhere to the requirements for nization’s Web site within 90 days after
written notice to its accredited pro- the survey report is made available to
viders or suppliers at § 488.8(e) in the those facilities for the most recent 3
case of an involuntary termination.
years, on an ongoing basis in a manner
(18) A statement that it will provide
specified by CMS. This acknowledge-
written notification to CMS of any pro-
posed changes in the organization’s ment includes all initial, triennial,

CMS-approved accreditation program full, follow-up, focused, and complaint
and that it agrees not to implement surveys.
270
(b) Additional information needed. If consideration until the reconsideration

CMS determines that additional infor- is administratively final.
mation is necessary to make a deter- (e) Public notice and comment. CMS
mination for approval or denial of the publishes a notice in the FEDERAL REG-
organization’s initial application or re- ISTER when the following conditions
application for CMS’s approval of an are met:
accreditation program, CMS will notify (1) Proposed notice. When CMS re-
the organization and afford it an oppor- ceives a complete application from a
tunity to provide the additional infor- national accrediting organization seek-
mation. ing CMS’s approval of an accreditation
(c)(1) Withdrawing an application. An program, it publishes a proposed no-
accrediting organization may withdraw tice. The proposed notice identifies the
its initial application for CMS’s-ap- organization and the type of providers
proval of its accreditation program at or suppliers to be covered by the ac-
any time before CMS publishes the
creditation program and provides 30
final notice described in paragraph
calendar days for the public to submit
(e)(2) of this section.
comments to CMS.
(2) Voluntary termination of a CMS-ap-
(2) Final notice. When CMS decides to
proved accreditation program. An accred-
iting organization may voluntarily ter- approve or disapprove a national ac-
minate its CMS-approved accreditation crediting organization’s application, it
program at any time. The accrediting publishes a final notice within 210 cal-
organization must notify CMS of its endar days from the date CMS deter-
decision to voluntarily terminate its mines the AO’s applications was com-
approved accreditation program at plete, unless the application was for a
least 90 calendar days in advance of the skilled nursing facility accreditation
effective date of the termination. In program. There is no timeframe for
accordance with the requirement at publication of a final notice for a na-
§ 488.4(a)(17)(i), the accrediting organi- tional accrediting organization’s appli-
zation must also provide written notice cation for approval of a skilled nursing
at least 90 days in advance of the effec- facility accreditation program. The
tive date of the termination to each of final notice specifies the basis for the
its deemed status providers or sup- CMS decision.
pliers. (i) Approval or re-approval. If CMS ap-
(d) Re-submitting a request. (1) Except proves or re-approves the accrediting
as provided in paragraph (d)(2) of this organization’s accreditation program,
section, an organization whose request the final notices describes how the ac-
for CMS’s approval or re-approval of an creditation program provides reason-
accreditation program has been denied able assurance. The final notice speci-
may resubmit its application if the or- fies the effective date and term of the
ganization satisfies all of the following approval (which may not be later than
requirements: the publication date of the notice and
(i) Revises its accreditation program which will not exceed 6 years.
to address the issues related to the de- (ii) Disapproval. If CMS does not ap-
nial of its previous request. prove the accrediting organization’s
(ii) Demonstrates that it can provide accreditation program, the final notice
reasonable assurance. describes, except in the case of a
(iii) Resubmits the application in its skilled nursing facility accreditation
entirety. program, how the organization fails to
(2) If an accrediting organization has provide reasonable assurance. In the
requested, in accordance with subpart case of an application for a skilled
D of this part, a reconsideration of nursing facility accreditation program,
CMS’s determination that its request
disapproval may be based on the pro-
for approval of an accreditation pro-
gram’s failure to provide reasonable as-
gram is denied, it may not submit a
new application for approval of an ac- surance, or on CMS’s decision to exer-

creditation program for the type of cise its discretion in accordance with
provider or supplier at issue in the re- section 1865(a)(1)(B) of the Act. The
271
§ 488.6 42 CFR Ch. IV (10–1–17 Edition)
final notice specifies the effective date on an ongoing basis. This review in-
of the decision. cludes, but is not limited to the fol-
lowing:
FR 38516, Aug. 14, 2017] (1) Review of the organization’s sur-
vey activity.
§ 488.6 Providers or suppliers that par- (2) Analysis of the results of the vali-
ticipate in the Medicaid program dation surveys under § 488.9(a)(1), in-
under a CMS-approved accredita- cluding the rate of disparity between
tion program.
certifications of the accrediting orga-
A provider or supplier that has been nization and certifications of the SA.
granted ‘‘deemed status’’ by CMS by (3) Review of the organization’s con-
virtue of its accreditation from a CMS- tinued fulfillment of the requirements
approved accreditation program is eli- in § 488.5(a).
gible to participate in the Medicaid (b) Comparability review. CMS assesses
program if they are not required under the equivalency of an accrediting orga-
Medicaid regulations to comply with nization’s CMS-approved program re-
any requirements other than Medicare quirements to the comparable Medi-
participation requirements. care requirements if the following con-
[80 FR 29837, May 22, 2015] ditions exist:
(1) CMS imposes new Medicare cer-
§ 488.7 Release and use of accredita- tification requirements or changes its
tion surveys. survey process.
A Medicare participating provider or (i) CMS provides written notice of
supplier deemed to meet program re- the changes to the affected accrediting
quirements in accordance with § 488.4 organization.
must authorize its accrediting organi- (ii) CMS specifies in its written no-
zation to release to CMS a copy of its tice a timeframe, not less than 30 cal-
most current accreditation survey and endar days from the date of the notice,
any information related to the survey for the accrediting organization to sub-
that CMS may require (including, but mit its proposed equivalent changes,
not limited to, corrective action including its implementation time-
plans). frame, for CMS review. CMS may ex-
(a) CMS may determine that a pro- tend the deadline after due consider-
vider or supplier does not meet the ap- ation of a written request for extension
plicable Medicare conditions or re- by the accrediting organization, sub-
quirements on the basis of its own in- mitted prior to the original deadline.
vestigation of the accreditation survey (iii) After completing the com-
or any other information related to the parability review CMS provides written
survey. notification to the organization wheth-
(b) With the exception of home er or not the accreditation program,
health agency surveys, general disclo- including the proposed revisions and
sure of an accrediting organization’s implementation timeframe, continues
survey information is prohibited under to meet or exceed all applicable Medi-
section 1865(b) of the Act. CMS may care requirements.
publically disclose an accreditation (iv) If, no later than 60 calendar days
survey and information related to the after receipt of the organization’s pro-
survey, upon written request, to the posed changes, CMS does not provide
extent that the accreditation survey the written notice to the organization
and survey information are related to required in paragraph (b)(1)(iii) of this
an enforcement action taken by CMS. section, then the revised program will
[80 FR 29837, May 22, 2015] be deemed to meet or exceed all appli-
cable Medicare requirements and to
§ 488.8 Ongoing review of accrediting have continued CMS approval.
organizations. (v) If an organization fails to submit
(a) Performance review. In accordance its proposed changes within the re-
with section 1875(b) of the Act, CMS quired timeframe, or fails to imple-
evaluates the performance of each ment the proposed changes that have
CMS-approved accreditation program been determined by CMS or deemed to
272
be comparable, CMS may open an ac- (iii) A description of the possible ac-
creditation program review in accord- tions that may be imposed by CMS
ance with paragraph (c) of this section. based on the findings of the accredita-
(2) An accrediting organization pro- tion program review.
poses to adopt new requirements or to (iv) The actions the accrediting orga-
change its survey process. nization must take to address the iden-
(i) An accrediting organization must tified deficiencies including a timeline
provide written notice to CMS of any for implementation not to exceed 180
proposed changes in its accreditation calendar days after receipt of the no-
requirements or survey process and tice that CMS is initiating an accredi-
must not implement any changes be- tation program review.
fore receiving CMS’s approval, except (2) CMS reviews the accrediting orga-
as provided below. nization’s plan of correction for accept-
(ii) If, no later than 60 calendar days ability.
after receipt of the organization’s pro- (3) If CMS determines as a result of
posed changes, CMS does not provide the accreditation program review or a
written notice to the organization that review of an application for renewal of
the accreditation program, including an existing CMS-approved accredita-
the proposed revisions, continues or tion program that the accrediting or-
does not continue to meet or exceed all ganization has failed to meet any of
applicable Medicare requirements, then the requirements of this subpart, CMS
the revised program will be deemed to may place the accrediting organiza-
meet or exceed all applicable Medicare tion’s CMS-approved accreditation pro-
requirements and to have continued gram on probation for a period up to
CMS approval. 180 calendar days to implement correc-
(iii) If an organization implements tive actions, not to exceed the accred-
changes that have neither been deter- iting organization’s current term of ap-
mined by CMS nor deemed to be com- proval. In the case of a renewal appli-
parable to the applicable Medicare re- cation where CMS has placed the ac-
quirements, CMS may open an accredi- creditation program on probation, CMS
tation program review in accordance indicates that any approval of the ap-
with paragraph (c) of this section. plication is conditional while the pro-
(c) CMS-approved accreditation program is placed on probation.
gram review. If a comparability or per- (i) Within 60 calendar days after the
formance review reveals evidence of end of any probationary period, CMS
substantial non-compliance of an ac- issues a written determination to the
crediting organization’s CMS-approved accrediting organization as to whether
accreditation program with the re- or not a CMS-approved accreditation
quirements of this subpart, CMS may program continues to meet the require-
initiate an accreditation program re- ments of this subpart, including the
view. reasons for the determination.
(1) If an accreditation program re- (ii) If CMS has determined that the
view is initiated, CMS provides written accrediting organization does not meet
notice to the organization indicating the requirements, CMS withdraws ap-
that its CMS-approved accreditation proval of the CMS-approved accredita-
program approval may be in jeopardy tion program. The notice of determina-
and that an accreditation program re- tion provided to the accrediting organi-
view is being initiated. The notice pro- zation includes notice of the removal
vides all of the following information: of approval, reason for the removal, in-
(i) A statement of the instances, cluding the effective date determined
rates or patterns of non-compliance in accordance with paragraph (c)(3)(iii)
identified, as well as other related in- of this section.
formation, if applicable. (iii) CMS publishes in the FEDERAL
(ii) A description of the process to be REGISTER a notice of its decision to
followed during the review, including a withdraw approval of a CMS-approved
description of the opportunities for the accreditation program, including the
accrediting organization to offer fac- reasons for the withdrawal, effective 60

tual information related to CMS’s find- calendar days from the date of publica-
ings. tion of the notice.
273
§ 488.9 42 CFR Ch. IV (10–1–17 Edition)
(d) Immediate jeopardy. If at any time (2) Voluntary termination by accred-

CMS determines that the continued ap- iting organization. When an accrediting
proval of a CMS-approved accredita- organization has voluntarily termi-
tion program of any accrediting orga- nated its CMS-approved accreditation
nization poses an immediate jeopardy program and provides its accredited
to the patients of the entities accred- providers and suppliers the notice re-
ited under that program, or the contin- quired at § 488.5(a)(17), an affected pro-
ued approval otherwise constitutes a vider’s or supplier’s deemed status con-
significant hazard to the public health, tinues in effect for 180 calendar days
CMS may immediately withdraw the after the termination effective date if
approval of a CMS-approved accredita- the provider or supplier submits an ap-
tion program of that accrediting orga- plication to another CMS-approved ac-
nization and publish a notice of the re- creditation program within 60 calendar
moval, including the reasons for it, in days from the date of the notice from
the FEDERAL REGISTER. the accrediting organization. The pro-
(e) Notification of providers or sup- vider or supplier must also provide
pliers. An accrediting organization written notice to the SA that it has
whose CMS approval of its accredita- submitted an application for accredita-
tion program has been withdrawn must tion under another CMS-approved ac-
notify, in writing, each of its accred- creditation program within this same
ited providers or suppliers of the with- 60-calendar day timeframe. Failure to
drawal of CMS approval and the impli- comply with the timeframe require-
cations in accordance with paragraph ments specified in this section will
(g)(1) of this section for the providers’ place the provider or supplier under the
or suppliers’ deemed status no later SAs authority for continued participa-
than 30 calendar days after the notice tion in Medicare and on-going moni-
is published in the FEDERAL REGISTER. toring.
(f) Request for reconsideration. Any ac- (h) Onsite observations of accrediting
crediting organization dissatisfied with organization operations. As part of the
a determination to withdraw CMS ap- application review process, the ongoing
proval of its accreditation program review process, or the continuing over-
sight of an accrediting organization’s
may request a reconsideration of that
performance, CMS may conduct at any
determination in accordance with sub-
time an onsite inspection of the ac-
part D of this part.
crediting organization’s operations and
(g) Continuation of deemed status—(1) offices to verify the organization’s rep-
Involuntary termination. After CMS re- resentations and to assess the organi-
moves approval of an accrediting orga- zation’s compliance with its own poli-
nization’s accreditation program, an cies and procedures. The onsite inspec-
affected provider’s or supplier’s deemed tion may include, but is not limited to,
status continues in effect for 180 cal- the review of documents, auditing
endar days after the removal of the ap- meetings concerning the accreditation
proval if the provider or supplier sub- process, observation of surveys, the
mits an application to another CMS- evaluation of survey results or the ac-
approved accreditation program within creditation decision-making process,
60 calendar days from the date of publi- and interviews with the organization’s
cation of the removal notice in the staff.
FEDERAL REGISTER. The provider or
supplier must also provide written no- [80 FR 29837, May 22, 2015]
tice to the SA that it has submitted an
application for accreditation under an- § 488.9 Validation surveys.
other CMS-approved accreditation pro- (a) Basis for survey. CMS may require
gram within this same 60-calendar day a survey of an accredited provider or
timeframe. Failure to comply with the supplier to validate the accrediting or-
timeframe requirements specified in ganization’s CMS-approved accredita-
this section will place the provider or tion process. These surveys are con-
supplier under the SAs authority for ducted on a representative sample

continued participation in Medicare basis, or in response to substantial al-
and on-going monitoring. legations of non-compliance.
274
(1) For a representative sample, the deemed to meet the applicable Medi-
survey may be comprehensive and ad- care conditions or requirements in ac-
dress all Medicare conditions or re- cordance with this section if all of the
quirements, or it may be focused on a following requirements are met:
specific condition(s) as determined by (1) It withdraws any prior refusal to
CMS. authorize its accrediting organization
(2) For a substantial allegation of to release a copy of the provider’s or
noncompliance, the SA surveys for any supplier’s current accreditation survey.
condition(s) or requirement(s) that (2) It withdraws any prior refusal to
CMS determines is related to the alle- allow a validation survey, if applicable.
gations. (3) CMS finds that the provider or
(b) Selection for survey. (1) A provider supplier meets all applicable Medicare
or supplier selected for a validation CoP, CfC, conditions of certification, or
survey must cooperate with the SA requirements.
that performs the validation survey.
(e) Impact of adverse actions. The ex-
(2) If a provider or supplier selected
istence of any performance review,
for a validation survey fails to cooper-
comparability review, deemed status
ate with the SA, it will no longer be
review, probationary period, or any
deemed to meet the Medicare condi-
other action by CMS, does not affect or
tions or requirements, but will be sub-
limit conducting any validation sur-
ject to a review by the SA in accord-
vey.
ance with § 488.10(a), and may be sub-
ject to termination of its provider [80 FR 29839, May 22, 2015]
agreement under § 489.53 of this chap-
ter. § 488.10 State survey agency review:
(c) Consequences of a finding of non- Statutory provisions.
compliance. (1) If a CMS validation sur- (a) Section 1864(a) of the Act requires
vey results in a finding that the pro- the Secretary to enter into an agree-
vider or supplier is out of compliance ment with any State that is able and
with one or more Medicare conditions willing to do so, under which appro-
or requirements, the provider or sup- priate State or local survey agencies
plier will no longer be deemed to meet will determine whether:
the Medicare conditions or require- (1) Providers or prospective providers
ments and will be subject to ongoing meet the Medicare conditions of par-
review by the SA in accordance with ticipation or requirements (for SNFs
§ 488.10(a) until the provider or supplier and NFs);
demonstrates compliance.
(2) Suppliers meet the conditions for
(2) CMS may take actions for the de-
coverage; and
ficiencies identified in the state valida-
tion survey in accordance with § 488.24, (3) Rural health clinics meet the con-
or may first direct the SA to conduct ditions of certification.
another survey of the provider’s or sup- (b) Section 1865(a) of the Act provides
plier’s compliance with specified Medi- that if an institution is accredited by a
care conditions or requirements before national accrediting organization rec-
taking the enforcement actions pro- ognized by the Secretary, it may be
vided for at § 488.24. deemed to have met the applicable con-
(3) If CMS determines that a provider ditions or requirements.
or supplier is not in compliance with (c) Section 1864(c) of the Act author-
applicable Medicare conditions or re- izes the Secretary to enter into agree-
quirements, the provider or supplier ments with state survey agencies for
may be subject to termination of the the purpose of conducting validation
provider or supplier agreement under surveys in institutions accredited by
§ 489.53 of this chapter or of the supplier an accreditation program recognized
agreement in accordance with the ap- by the Secretary.
plicable supplier conditions and any (d) Section 1865(c) provides that an
other applicable intermediate sanc- accredited institution that is found
tions and remedies. after a validation survey to have sig-

(d) Re-instating deemed status. An ac- nificant deficiencies related to health
credited provider or supplier will be and safety of patients will no longer
275
§ 488.11 42 CFR Ch. IV (10–1–17 Edition)
meet the applicable conditions or re- tion requirements, the SA will conduct
quirements. a full review in a timely manner.
[53 FR 22859, June 17, 1988, as amended at 56 [80 FR 29839, May 22, 2015]
FR 48879, Sept. 26, 1991; 58 FR 61842, Nov. 23,
1993; 62 FR 46037, Aug. 29, 1997; 80 FR 29839, § 488.14 Effect of QIO review.
May 22, 2015] When a QIO is conducting review ac-
tivities under section 1154 of the Act
§ 488.11 State survey agency functions. and part 466 of this chapter, its activi-
State and local agencies that have ties are in lieu of the utilization review
agreements under section 1864(a) of the and evaluation activities required of
Act perform the following functions: health care institutions under sections
(a) Survey and make recommenda- 1861(e)(6), and 1861(k) of the Act.
tions regarding the issues listed in [59 FR 56237, Nov. 10, 1994]
§ 488.10.
(b) Conduct validation surveys of § 488.18 Documentation of findings.
deemed status providers and suppliers (a) The findings of the State agency
as provided in § 488.9. with respect to each of the conditions
(c) Perform other surveys and carry of participation, requirements (for
out other appropriate activities and SNFs and NFs), or conditions for cov-
certify their findings to CMS. erage must be adequately documented.
(d) Make recommendations regarding When the State agency certifies to the
the effective dates of provider agree- Secretary that a provider or supplier is
ments and supplier approvals in ac- not in compliance with the conditions
cordance with § 489.13 of this chapter. or requirements (for SNFs and NFs),
and therefore not eligible to partici-
pate in the program, such documenta-
FR 29839, May 22, 2015]
tion includes, in addition to the de-
§ 488.12 Effect of survey agency certifi- scription of the specific deficiencies
cation. which resulted in the agency’s rec-
ommendation, any provider or supplier
Certifications by the State survey response.
agency represent recommendations to (b) If a provider or supplier is cer-
CMS. tified by the State agency as in compli-
(a) On the basis of these rec- ance with the conditions or participa-
ommendations, CMS will determine tion requirements (for SNFs and NFs)
whether: or as meeting the requirements for spe-
(1) A provider or supplier is eligible cial certification (see § 488.54), with de-
to participate in or be covered under ficiencies not adversely affecting the
the Medicare program; or health and safety of patients, the fol-
(2) A provider or supplier accredited lowing information will be incor-
under a CMS-approved accreditation porated into the finding:
program remains deemed to meet the (1) A statement of the deficiencies
Medicare conditions or requirements, that were found.
or will be placed under the jurisdiction (2) A description of further action
of the SA and subject to further en- that is required to remove the defi-
forcement actions in accordance with ciencies.
the provisions at § 488.9. (3) A time-phased plan of correction
(b) Notice of CMS’s determination developed by the provider and supplier
will be sent to the provider or supplier. and concurred with by the State agen-
cy.
[53 FR 22859, June 17, 1988, as amended at 80 (4) A scheduled time for a resurvey of
FR 29839, May 22, 2015] the institution or agency to be con-
ducted by the State agency within 90
§ 488.13 Loss of accreditation.
days following the completion of the
If an accrediting organization noti- survey.
fies CMS that it is terminating a pro- (c) If, on the basis of the State cer-
vider or supplier due to non-compli- tification, the Secretary determines
ance with its CMS-approved accredita- that the provider or supplier is eligible
276
to participate, the information de- quirements (for SNFs and NFs) or con-
scribed in paragraph (b) of this section ditions for coverage will supersede the
will be incorporated into a notice of State survey agency’s previous certifi-
eligibility to the provider or supplier. cation.
(d) If the State agency receives infor-
(Secs. 1102, 1814, 1861, 1863 through 1866, 1871,
mation to the effect that a hospital or and 1881; 42 U.S.C. 1302, 1395f, 1395x, 1395z
a critical access hospital (as defined in through 1395cc, 1395hh, and 1395rr)
section 1861(mm)(1) of the Act) has vio-
lated § 489.24 of this chapter, the State [45 FR 74833, Nov. 12, 1981. Redesignated and
agency is to report the information to amended at 53 FR 23100, June 17, 1988, and
further amended at 54 FR 5373, Feb. 2, 1989; 56
CMS promptly. FR 48879, Sept. 26, 1991; 59 FR 56237, Nov. 10,
[39 FR 2251, Jan. 17, 1974. Redesignated at 39 1994]
FR 11419, Mar. 28, 1974, and further redesig-
nated at 42 FR 52826, Sept. 30, 1977. Redesig- § 488.24 Certification of noncompli-
nated at 53 FR 23100, June 17, 1988; 59 FR ance.
32120, June 22, 1994; 59 FR 56237, Nov. 10, 1994;
(a) Special rules for certification of
62 FR 46037, Aug. 29, 1997]
noncompliance for SNFs and NFs are
EFFECTIVE DATE NOTE: At 59 FR 32120, June set forth in § 488.330.
22, 1994, § 488.18(d) was added. This paragraph
(b) The State agency will certify that
contains information collection and record-
keeping requirements and will not become a provider or supplier is not or is no
effective until approval has been given by longer in compliance with the condi-
the Office of Management and Budget. tions of participation or conditions for
coverage where the deficiencies are of
§ 488.20 Periodic review of compliance such character as to substantially
and approval. limit the provider’s or supplier’s capac-
(a) Determinations by CMS to the ef- ity to furnish adequate care or which
fect that a provider or supplier is in adversely affect the health and safety
compliance with the conditions of par- of patients; or
ticipation, or requirements (for SNFs (c) If CMS determines that an insti-
and NFs), or the conditions for cov- tution or agency does not qualify for
erage are made as often as CMS deems participation or coverage because it is
necessary and may be more or less not in compliance with the conditions
than a 12-month period, except for of participation or conditions for cov-
SNFs, NFs and HHAs. (See § 488.308 for erage, or if a provider’s agreement is
special rules for SNFs and NFs.) terminated for that reason, the institu-
(b) The responsibilities of State sur- tion or agency has the right to request
vey agencies in the review and certifi- that the determination be reviewed.
cation of compliance are as follows: (Appeals procedures are set forth in
(1) Resurvey providers or suppliers as part 498 of this chapter.)
frequently as necessary to ascertain
compliance and confirm the correction [59 FR 56237, Nov. 10, 1994]
of deficiencies;
§ 488.26 Determining compliance.
(2) Review reports prepared by a Pro-
fessional Standards Review Organiza- (a) Additional rules for certification
tion (authorized under Part B Title XI of compliance for SNFs and NFs are set
of the Act) or a State inspection of forth in § 488.330.
care team (authorized under Title XIX (b) The decision as to whether there
of the Act) regarding the quality of a is compliance with a particular re-
facility’s care; quirement, condition of participation,
(3) Evaluate reports that may pertain or condition for coverage depends upon
to the health and safety of patients; the manner and degree to which the
and provider or supplier satisfies the var-
(4) Take appropriate actions that ious standards within each condition.
may be necessary to achieve compli- Evaluation of a provider’s or supplier’s
ance or certify noncompliance to CMS. performance against these standards
(c) A State survey agency certifi- enables the State survey agency to
cation to CMS that a provider or sup- document the nature and extent of de-
plier is no longer in compliance with ficiencies, if any, with respect to a par-
the conditions of participation or re- ticular function, and to assess the need
277
§ 488.28 42 CFR Ch. IV (10–1–17 Edition)
for improvement in relation to the pre- CMS. In the case of an immediate jeop-
scribed conditions. ardy situation, CMS may require a
(c) The State survey agency must ad- shorter time period for achieving com-
here to the following principles in de- pliance.
termining compliance with participa- (b) The existing deficiencies noted ei-
tion requirements: ther individually or in combination
(1) The survey process is the means neither jeopardize the health and safe-
to assess compliance with Federal ty of patients nor are of such character
health, safety and quality standards; as to seriously limit the provider’s ca-
(2) The survey process uses resident pacity to render adequate care.
and patient outcomes as the primary (c)(1) If it is determined during a sur-
means to establish the compliance vey that a provider or supplier is not in
process of facilities and agencies. Spe-
compliance with one or more of the
cifically, surveyors will directly ob-
standards, it is granted a reasonable
serve the actual provision of care and
time to achieve compliance.
services to residents and/or patients,
and the effects of that care, to assess (2) The amount of time depends upon
whether the care provided meets the the—
needs of individual residents and/or pa- (i) Nature of the deficiency; and
tients. (ii) State survey agency’s judgment
(3) Surveyors are professionals who as to the capabilities of the facility to
use their judgment, in concert with provide adequate and safe care.
Federal forms and procedures, to deter- (d) Ordinarily a provider or supplier
mine compliance; is expected to take the steps needed to
(4) Federal procedures are used by all achieve compliance within 60 days of
surveyors to ensure uniform and con- being notified of the deficiencies but
sistent application and interpretation the State survey agency may rec-
of Federal requirements; ommend that additional time be grant-
(5) Federal forms are used by all sured by the Secretary in individual situa-
veyors to ensure proper recording of tions, if in its judgment, it is not rea-
findings and to document the basis for sonable to expect compliance within 60
the findings. days, for example, a facility must ob-
(d) The State survey agency must use tain the approval of its governing body,
the survey methods, procedures, and or engage in competitive bidding.
forms that are prescribed by CMS.
(e) The State survey agency must en- [59 FR 56237, Nov. 10, 1994, as amended at 77
sure that a facility’s or agency’s actual FR 67164, Nov. 8, 2012; 80 FR 29839, May 22,
2015]
provision of care and services to resi-
dents and patients and the effects of § 488.30 Revisit user fee for revisit sur-
that care on such residents and pa- veys.
tients are assessed in a systematic
manner. (a) Definitions. As used in this sec-
tion, the following definitions apply:
Certification (both initial and recer-
FR 67164, Nov. 8, 2012]
tification) means those activities as
§ 488.28 Providers or suppliers, other defined in § 488.1.
than SNFs, NFs, and HHAs with de- Complaint surveys means those sur-
ficiencies. veys conducted on the basis of a sub-
(a) If a provider or supplier is found stantial allegation of noncompliance,
to be deficient in one or more of the as defined in § 488.1. The requirements
standards in the conditions of partici- of sections 1819(g)(4) and 1919(g)(4) of
pation, conditions for coverage, or con- the Social Security Act and § 488.332
ditions for certification or require- apply to complaint surveys.
ments, it may participate in, or be cov- Provider of services, provider, or sup-
ered under, the Medicare program only plier has the meaning defined in § 488.1,
if the provider or supplier has sub- and ambulatory surgical centers,
mitted an acceptable plan of correction transplant centers, and religious non-

for achieving compliance within a rea- medical health care institutions sub-
sonable period of time acceptable to ject to §§ 416.2, 482.70, and 403.702 [C8] of
278
this chapter, respectively, will be sub- ited as an offset collection to be used

ject to user fees unless otherwise ex- exclusively for survey and certification
empted. activities conducted by State survey
Revisit survey means a survey per- agencies pursuant to section 1864 of the
formed with respect to a provider or Act or by CMS, and will be available
supplier cited for deficiencies during an for CMS until expended. CMS may de-
initial certification, recertification, or vise other collection methods as it
substantiated complaint survey and deems appropriate. In determining
that is designed to evaluate the extent these methods, CMS will consider effi-
to which previously-cited deficiencies ciency, effectiveness, and convenience
have been corrected and the provider or for the providers, suppliers, and CMS.
supplier is in substantial compliance CMS may consider any method allowed
with applicable conditions of participa- by law, including: Credit card; elec-
tion, requirements, or conditions for tronic fund transfer; check; money
coverage. Revisit surveys include both order; and offset collections from
offsite and onsite review. claims submitted.
Substantiated complaint survey means (2) Fees for revisit surveys under this
a complaint survey that results in the section are not allowable items on a
proof or finding of noncompliance at cost report, as identified in part 413,
the time of the survey, a finding that subpart B of this chapter, under title
noncompliance was proven to exist, but XVIII of the Act.
was corrected prior to the survey, and (3) Fees for revisit surveys will be
includes any deficiency that is cited due for any revisit surveys conducted
during a complaint survey, whether or during the time period for which au-
not the cited deficiency was the origi- thority to levy a revisit user fee exists.
nal subject of the complaint.
(e) Reconsideration process for revisit
(b) Criteria for determining the fee. (1)
user fees. (1) CMS will review a request
The provider or supplier will be as-
for reconsideration of an assessed re-
sessed a revisit user fee based upon one
visit user fee—
or more of the following:
(i) The average cost per provider or (i) If a provider or supplier believes
supplier type. an error of fact has been made in the
(ii) The type of revisit survey con- application of the revisit user fee, such
ducted (onsite or offsite). as clerical errors, billing for a fee al-
(iii) The size of the provider or sup- ready paid, or assessment of a fee when
plier. there was no revisit conducted, and
(iv) The number of follow-up revisits (ii) If the request for reconsideration
resulting from uncorrected defi- is received by CMS within 14 calendar
ciencies. days from the date identified on the re-
(v) The seriousness and number of de- visit user fee assessment notice.
ficiencies. (2) CMS will issue a credit toward
(2) CMS may adjust the fees to ac- any future revisit surveys conducted, if
count for any regional differences in the provider or supplier has remitted
cost. an assessed revisit user fee and for
(c) Fee schedule. CMS must publish in which a reconsideration request is
the FEDERAL REGISTER the proposed found in favor of the provider or sup-
and final notices of a uniform fee plier. If in the event that CMS judges
schedule before it assesses revised re- that a significant amount of time has
visit user fees. The notices must set elapsed before such a credit is used,
forth which criteria will be used and CMS will refund the assessed revisit
how, as well as the amounts of the as- user fee amount paid to the provider or
sessed fees based on the criteria as supplier.
identified in paragraph (b) of this sub- (3) CMS will not reconsider the as-
part. sessment of revisit user fees that re-
(d) Collection of fees. (1) Fees for request reconsideration of the survey
visit surveys under this section may be findings or deficiency citations that
deducted from amounts otherwise pay- may have given rise to the revisit, the
able to the provider or supplier. As revisit findings, the need for the revisit
they are collected, fees will be depos- itself, or other similarly identified
279
§ 488.52 42 CFR Ch. IV (10–1–17 Edition)
basis for the assessment of the revisit ing such other requirements as the
user fee. Secretary finds necessary under sec-
(f) Enforcement. If the full revisit user tion 1861(e)(9). (For further information
fee payment is not received within 30 relating to the exception in section
calendar days from the date identified 1861(e)(5) of the Act, see paragraph (c)
on the revisit user fee assessment no- of this section.)
tice, CMS may terminate the facility’s (c) Temporary waiver of 24-hour nurs-
provider agreement (pursuant to ing requirement of 24-hour registered
§ 489.53(a)(16) of this chapter) and en- nurse requirement. CMS may waive the
rollment in the Medicare program or
requirement contained in section
the supplier’s enrollment and partici-
1861(e)(5) that a hospital must provide
pation in the Medicare program (pursu-
24-hour nursing service furnished or su-
ant to § 424.535(a)(1) of this chapter).
pervised by a registered nurse. Such a
[72 FR 53648, Sept. 19, 2007, as amended at 82 waiver may be granted when the fol-
FR 36635, Aug. 4, 2017] lowing criteria are met:
(1) The hospital’s failure to comply
Subpart B—Special Requirements fully with the 24-hour nursing require-
ment is attributable to a temporary
§ 488.52 [Reserved]
shortage of qualified nursing personnel
§ 488.54 Temporary waivers applicable in the area in which the hospital is lo-
to hospitals. cated.
(a) General provisions. If a hospital is (2) A registered nurse is present on
found to be out of compliance with one the premises to furnish or supervise
or more conditions of participation for the nursing services during at least the
hospitals, as specified in part 482 of daytime shift, 7 days a week.
this chapter, a temporary waiver may (3) The hospital has in charge, on all
be granted by CMS. CMS may extend a tours of duty not covered by a reg-
temporary waiver only if such a waiver istered nurse, a licensed practical (vo-
would not jeopardize or adversely af- cational) nurse.
fect the health and safety of patients. (4) The hospital complies with all re-
The waiver may be issued for any one quirements specified in paragraph (a)
year period or less under certain cir- of this section.
cumstances. The waiver may be with- (d) Temporary waiver for technical per-
drawn earlier if CMS determines this sonnel. CMS may waive technical per-
action is necessary to protect the sonnel requirements, issued under sec-
health and safety of patients. A waiver tion 1861(e)(9) of the Act, contained in
may be granted only if: the Conditions of Participation; Hos-
(1) The hospital is located in a rural
pitals (part 482 of this chapter). Such a
area. This includes all areas not delin-
waiver must take into account the
eated as ‘‘urban’’ by the Bureau of the
availability of technical personnel and
Census, based on the most recent cen-
sus; the educational opportunities for tech-
(2) The hospital has 50 or fewer inpa- nical personnel in the area in which
tient hospital beds; the hospital is located. CMS may also
(3) The character and seriousness of limit the scope of services furnished by
the deficiencies do not adversely affect a hospital in conjunction with the
the health and safety of patients; and waiver in order not to adversely affect
(4) The hospital has made and con- the health and safety of the patients.
tinues to make a good faith effort to In addition, the hospital must also
comply with personnel requirements comply with all requirements specified
consistent with any waiver. in paragraph (a) of this section.
(b) Minimum compliance requirements.
Each case will have to be decided on its FR 11419, Mar. 28, 1974, and amended at 41 FR
individual merits, and while the degree 27962, July 8, 1976. Further redesignated at 42
and extent of compliance will vary, the FR 52826, Sept. 30, 1977, and amended at 47
institution must, as a minimum, meet FR 31531, July 20, 1982; 51 FR 22041, June 17,
all of the statutory conditions in sec- 1986. Redesignated at 53 FR 23100, June 17,
tion 1861(e)(1)–(8), in addition to meet- 1988]
280
§ 488.56 Temporary waivers applicable comply with § 483.70(h) of this chapter,

to skilled nursing facilities. but such compliance is impeded by the
(a) Waiver of 7-day registered nurse re- unavailability of physicians in the
quirement. To the extent that § 483.35 of area.
this chapter requires any skilled nurs- [39 FR 35777, Oct. 3, 1974. Redesignated and
ing facility to engage the services of a amended at 42 FR 52826, Sept. 30, 1977. Fur-
registered nurse more than 40 hours a ther redesignated and amended at 53 FR
week, the Secretary may waive such 23100, June 17, 1988, and further amended at
requirement for such periods as he 56 FR 48879, Sept. 26, 1991; 57 FR 43925, Sept.
23, 1992; 81 FR 68871, Oct. 4, 2016; 82 FR 32260,
deems appropriate if, based upon docu- July 13, 2017]
mented findings of the State agency,
he determines that: § 488.60 Special procedures for ap-
(1) Such facility is located in a rural proving end stage renal disease fa-
area and the supply of skilled nursing cilities.
facility services in such area is not suf- (a) Consideration for approval. An
ficient to meet the needs of individual ESRD facility that wishes to be ap-
patients therein, proved or that wishes an expansion of
(2) Such facility has at least one dialysis services to be approved for
fulltime registered nurse who is regu- coverage, in accordance with part 494
larly on duty at such facility 40 hours of this chapter, must secure a deter-
a week, and mination by the Secretary. To secure a
(3) Such facility (i) has only patients determination, the facility must sub-
whose attending physicians have indi- mit the following documents and data
cated (through physicians’ orders or for consideration by the Secretary:
admission notes) that each such pa- (1) Certification by the State agency
tient does not require the services of a referred to in § 488.12 of this part.
registered nurse for a 48-hour period, or (2) Data furnished by ESRD network
(ii) has made arrangements for a reg- organizations and recommendations of
istered nurse or a physician to spend the Public Health Service concerning
such time at the facility as is deter- the facility’s contribution to the ESRD
mined necessary by the patient’s at- services of the network.
tending physician to provide necessary (3) Data concerning the facility’s
services on days when the regular compliance with professional norms
fulltime registered nurse is not on and standards.
duty. (4) Data pertaining to the facility’s
(4) Such facility has made and con- qualifications for approval or for any
tinues to make a good faith effort to expansion of services.
comply with the more than 40-hour (b) Determining compliance with mini-
registered nurse requirement, but such mal utilization rates: Time limitations—(1)
compliance is impeded by the unavail- Unconditional status. A facility which
ability of registered nurses in the area. meets minimal utilization require-
(b) Waiver of medical director requirements will be assigned this status as
ment. To the extent that § 483.70(h) of long as it continues to meet these re-
this chapter requires any skilled nurs- quirements.
ing facility to engage the services of a (2) Conditional status. A conditional
medical director either part-time or status may be granted to a facility for
full-time, the Secretary may waive not more than four consecutive cal-
such requirement for such periods as he endar years and will not be renewable
deems appropriate if, based upon docu- (see § 405.2122(b) of this chapter). Its
mented findings of the State agency, status may be examined each calendar
he determines that: year to ascertain its compliance with
(1) Such facility is located in an area Subpart U.
where the supply of physicians is not (3) Exception status. Under unusual
sufficient to permit compliance with circumstances (see § 405.2122 (b) of this
this requirement without seriously re- chapter) the Secretary may grant a
ducing the availability of physician time-limited exception to a facility
services within the area, and which is not in compliance with the
(2) Such facility has made and con- minimal utilization rate(s) for either
tinues to make a good faith effort to unconditional status or conditional
281
§ 488.61 42 CFR Ch. IV (10–1–17 Edition)
status. This exception status may be § 488.61 Special procedures for ap-
granted, and may be renewed on an an- proval and re-approval of organ
nual basis, under circumstances where transplant centers.
rigid application of minimal utilization For the purposes of this subpart, the
rate requirements would adversely af- survey, certification, and enforcement
fect the achievement of ESRD program procedures described at 42 CFR part
objectives. 488, subpart A apply to transplant cen-
(c) New applicant. A facility which ters, including the periodic review of
has not previously participated in the compliance and approval described at
ESRD program must submit a plan de- § 488.20.
tailing how it expects to meet the con- (a) Initial approval procedures for
ditional minimal utilization rate sta- transplant centers that are not Medicare-
tus by the end of the second calendar approved as of June 28, 2007. A trans-
year of its operation under the pro- plant center, including a kidney trans-
gram and meet the unconditional mini- plant center, may submit a request to
mal utilization rate status by the end CMS for Medicare approval at any
of the fourth calendar year of its oper- time.
ation under the program. (1) The request, signed by a person
(d) Notification. The Secretary will authorized to represent the center (for
notify each facility and its network co- example, a chief executive officer),
ordinating council of its initial and its must include:
subsequent minimal utilization rate (i) The hospital’s Medicare provider
classification. I.D. number;
(e) Failure to meet minimal utilization (ii) Name(s) of the designated pri-
rate. A facility failing to meet stand- mary transplant surgeon and primary
ards for unconditional status or condi- transplant physician; and,
tional status, or if applicable, for ex- (iii) A statement from the OPTN that
ception status, will be so notified at the center has complied with all data
the time of such classification. submission requirements.
(f) Interim regulations participant. A (2) To determine compliance with the
facility previously participating under clinical experience and outcome re-
the interim regulations will not be ap- quirements at §§ 482.80(b) and 482.80(c),
proved under the program established CMS will review the data contained in
by subpart U until it has demonstrated the most recent OPTN Data Report and
that it meets all the applicable re- 1-year patient and graft survival data
quirements of this subpart, including contained in the most recent Scientific
the appropriate minimal utilization Registry of Transplant Beneficiary
rate. It may continue under the in- (SRTR) center-specific report.
terim program only for a period not to (3) If CMS determines that a trans-
exceed 1 year from the effective date of plant center has not met the data sub-
these amendments (see § 405.2100(c) of mission, clinical experience, or out-
this chapter). During this period it come requirements, CMS may deny the
may demonstrate its ability to meet request for approval or may review the
the appropriate minimal utilization center’s compliance with the condi-
rate. Failure to qualify under this sub- tions of participation at §§ 482.72
part will automatically terminate cov- through 482.76 and §§ 482.90 through
482.104 of this chapter, using the proce-
erage of such facility’s services under
dures described at 42 CFR part 488, sub-
the ESRD program at the end of such
part A, to determine whether the cen-
year.
ter’s request will be approved. CMS
[41 FR 22510, June 3, 1976. Redesignated at 42 will notify the transplant center in
FR 52826, Sept. 30, 1977, and further amended writing whether it is approved and, if
at 45 FR 58124, Sept. 2, 1980. Redesignated approved, of the effective date of its
and amended at 53 FR 23100, June 17, 1988; 73 approval.
FR 20474, Apr. 15, 2008]

(4) CMS will consider mitigating fac-
tors in accordance with paragraphs (f),
(g), and (h) of this section.
282
(5) If CMS determines that a trans- longer apply to the center as of the
plant center has met the data submis- date of its approval. Once CMS ap-
sion, clinical experience, and outcome proves an extra-renal organ transplant
requirements, CMS will review the cen- center under the conditions of partici-
ter’s compliance with the conditions of pation, the NCDs no longer apply to
participation contained at §§ 482.72 the center as of the date of its ap-
through 482.76 and §§ 482.90 through proval.
482.104 of this chapter using the proce- (4) If a transplant center that is
dures described at 42 CFR part 488, sub- Medicare approved as of June 28, 2007
part A. If the transplant center is submits a request for approval under
found to be in compliance with all the the CoPs at §§ 482.72 through 482.104 of
conditions of participation at §§ 482.72 this chapter but CMS does not approve
through 482.104, except for § 482.82 of the transplant center, or if the trans-
this chapter (Re-approval Require- plant center does not submit its re-
ments), CMS will notify the transplant quest to CMS for Medicare approval
center in writing of the effective date under the CoPs by December 26, 2007,
of its Medicare-approval. CMS will no- CMS will revoke the transplant cen-
tify the transplant center in writing if ter’s approval under the conditions for
it is not Medicare-approved. coverage for kidney transplant centers
(6) A kidney transplant center may or the national coverage decisions for
submit a request for initial approval extra-renal transplant centers, as ap-
after performing at least 3 transplants plicable, and the transplant center will
over a 12-month period. no longer be reimbursed for services
(b) Initial approval procedures for provided to Medicare beneficiaries.
transplant centers, including kidney CMS will notify the transplant center
transplant centers, that are Medicare ap- in writing of the effective date of its
proved as of June 28, 2007. (1) A trans- loss of Medicare approval.
plant center that wants to continue to (c) Re-approval procedures. Once Medi-
be Medicare approved must be in com- care-approved, transplant centers, in-
pliance with the conditions of partici- cluding kidney transplant centers,
pation at §§ 482.72 through 482.104 as of must be in continuous compliance with
June 28, 2007 and submit a request to all the conditions of participation for
CMS for Medicare approval under the transplant centers at §§ 482.72 through
conditions of participation no later 482.104 of this chapter, except for
than December 26, 2007, using the proc- § 482.80 (initial approval requirements).
ess described in paragraph (a)(1) of the (1) CMS will review the transplant
section. center’s data on an on-going basis and
(2) CMS will determine whether to in making re-approval determinations.
approve the transplant center, using (i) To determine compliance with the
the procedures described in paragraphs data submission requirements at
(a)(2) through (a)(5) of this section. § 482.82(a) of this chapter, CMS will re-
Until CMS makes a determination quest data submission data from the
whether to approve the transplant cen- OPTN for the previous 3 calendar
ter under the conditions of participa- years.
tion at §§ 482.72 through 482.104, the (ii) To determine compliance with
transplant center will continue to be the clinical experience and outcome re-
Medicare approved under the end stage quirements at § 482.82(b) and (c) of this
renal disease (ESRD) conditions for chapter, CMS will review the data con-
coverage (CfCs) in part 405, subpart U tained in the most recent OPTN Data
of this chapter for kidney transplant Report for the previous 3 years and 1-
centers or the pertinent national cov- year patient and graft survival data
erage decisions (NCDs) for extra-renal contained in the most recent SRTR
organ transplant centers, as applicable, center-specific reports.
and the transplant center will continue (2) CMS may choose to review the
to be reimbursed for services provided transplant center for compliance with
to Medicare beneficiaries. §§ 482.72 through 482.76 and 482.90
(3) Once CMS approves a kidney through 482.104 of this chapter, using
transplant center under the conditions the procedures described at 42 CFR
of participation, the ESRD CfCs no part 488, subpart A.
283
§ 488.61 42 CFR Ch. IV (10–1–17 Edition)
(3) CMS will consider mitigating fac- been implemented and institutional-
tors in accordance with paragraphs (f), ized on a sustainable basis, and that
(g), and (h) of this section. are supported by outcomes more recent
(4) CMS will notify the transplant than the latest available SRTR report,
center in writing if its approval is for which there is a sufficient post-
being revoked and of the effective date transplant patient and graft survival
of the revocation. period and a sufficient number of
(d) Loss of Medicare Approval. Centers transplants such that CMS finds that
that have lost their Medicare approval the program demonstrates present-day
may seek re-entry into the Medicare compliance with the requirements at
program at any time. A center that has § 482.80(c)(2)(ii)(C) or § 482.82(c)(2)(ii)(C)
lost its Medicare approval must: of this chapter;
(1) Request initial approval using the (v) Whether the program has made
procedures described in § 488.61(a); extensive use of innovative transplan-
(2) Be in compliance with §§ 482.72 tation practices relative to other
through 482.104 of this chapter, except transplant programs, such as a high
for § 482.82 (Re-approval Requirements), rate of transplantation of individuals
at the time of the request for Medicare who are highly sensitized or children
approval; and who have undergone a Fontan proce-
(3) Submit a report to CMS docu- dure compared to most other trans-
menting any changes or corrective ac- plant programs, where CMS finds that
tions taken by the center as a result of the innovative practices are supported
the loss of its Medicare approval sta- by evidence-based published research
tus. literature or nationally recognized
(e) Transplant Center Inactivity. A standards or Institution Review Board
transplant center may remain inactive (IRB) approvals, and the SRTR risk-ad-
and retain its Medicare approval for a justment methodology does not take
period not to exceed 12 months. A the relevant key factors into consider-
transplant center must notify CMS ation; and
upon its voluntary inactivation as re-
(vi) Whether the program’s perform-
quired by § 482.74(a)(3) of this chapter.
ance, based on the OPTN method of
(f) Consideration of mitigating factors
calculating patient and graft survival,
in initial approval and re-approval sur-
is within the OPTN’s thresholds for ac-
vey, certification, and enforcement ac-
ceptable performance and does not flag
tions for transplant centers—(1) Factors.
OPTN performance review under the
Except for situations of immediate
applicable OPTN policy.
jeopardy or deficiencies other than
failure to meet requirements of § 482.80 (2) Content. A request for consider-
or § 482.82 of this chapter, CMS will ation of mitigating factors must in-
consider such mitigating factors as clude sufficient information to permit
may be appropriate in light of the na- an adequate review and understanding
ture of the deficiency and cir- of the transplant program, the factors
cumstances, including (but not limited that have contributed to outcomes,
to) the following, in making a decision program improvements or innovations
of initial and re-approval of a trans- that have been implemented or
plant center that does not meet the planned, and in the case of natural dis-
data submission, clinical experience, or asters, the recovery actions planned.
outcome requirements: Examples of information to be sub-
(i) The extent to which outcome mitted with each request include (but
measures are not met or exceeded; are not limited to) the following:
(ii) Availability of Medicare-approved (i) The name and contact information
transplant centers in the area; for the transplant hospital and the
(iii) Extenuating circumstances (for names and roles of key personnel of the
example, natural disaster) that have a transplant program;
temporary effect on meeting the condi- (ii) The type of organ transplant pro-
tions of participation; gram(s) for which approval is re-
(iv) Program improvements that sub- quested;

stantially address root causes of graft (iii) The conditions of participation
failures or patient deaths, that have that the program does not meet for
284
which the transplant center is request- (vii) For requests based on natural
ing CMS’ review for mitigating factors; disasters or public health emergency:
(iv) The program’s organizational (A) A description of the disaster or
chart with full-time equivalent levels, emergency, the specific impact on the
roles, and structure for reporting to program, the time periods of the
hospital leadership; event(s) and of its immediate recovery
(v) For applications involving sub- aftermath;
standard patient or graft survival, the (B) Identification of the transplants
rationale and supporting evidence for that occurred during the period for
CMS’ review includes, but is not lim- which the request is being made; and
ited to— (C) The approximate date when the
(A) Root Cause Analysis for patient program believes it substantially re-
deaths and graft failures, including fac- covered from the event(s), or believes
tors the program has identified as like- it will recover if substantial recovery
ly causal or contributing factors for has not been accomplished at the time
patient deaths and graft failures; of the request.
(B) Program improvements that have (3) Timing. Within 14 calendar days
been implemented and improvements after CMS has issued formal written
that are planned; notice of a condition-level deficiency
(C) Patient and donor/organ selection to the program, CMS must receive no-
criteria and evaluation protocols, in- tification of the program’s intent to
cluding methods for pre-transplant pa- seek mitigating factors approval or re-
tient evaluation by cardiologists, he- approval, and receive all information
matologists, nephrologists, and psychi- for consideration of mitigating factors
atrists or psychologists to the extent within 120 calendar days of the CMS
applicable; written notification for a deficiency
(D) Waitlist management protocols due to data submission, clinical experi-
and practices relevant to outcomes; ence or outcomes at § 482.80 or § 482.82 of
(E) Pre-operative management proto- this chapter. Failure to meet these
cols and practices; timeframes may be the basis for denial
(F) Immunosuppression/infection proof mitigating factors. However, CMS
phylaxis protocols; may permit an extension of the
(G) Post-transplant monitoring and timeline for good cause, such as a de-
management protocols and practices; clared public health emergency.
(H) Quality Assessment and Perform- (g) Results of mitigating factors re-
ance Improvement (QAPI) Program view—(1) Actions. Upon review of the re-
meeting minutes from the most recent quest to consider mitigating factors,
four meetings and attendance rosters CMS may take the following actions:
from the most recent 12 months; (i) Approve initial approval or re-ap-
(I) Quality dashboard and other per- proval of a program’s Medicare partici-
formance indicators; and pation based upon approval of miti-
(J) The most recent data regarding gating factors;
transplants that have been made and (ii) Deny the program’s request for
for outcomes in terms of both patient Medicare approval or re-approval based
survival and graft survival; on mitigating factors.
(vi) For mitigating factors requests (iii) Offer a time-limited Systems Im-
based on innovative practice: provement Agreement, in accordance
(A) A description of the innovations with paragraph (h) of this section,
that have been implemented and iden- when a transplant program has waived
tification of the specific cases for its appeal rights, has implemented sub-
which the innovative practices are rel- stantial program improvements that
evant so as to enable the patient and address root causes and are institution-
graft survival data for such cases to be ally supported by the hospital’s gov-
compared with all other transplants for erning body on a sustainable basis, and
at least the period covered by the lat- has requested more time to design or
est available SRTR report. implement additional improvements or
(B) The literature, research, or other demonstrate compliance with CMS

evidentiary basis that supports consid- outcome requirements. Upon comple-
eration of the practice(s) as innovative. tion of the Systems Improvement
285
§ 488.61 42 CFR Ch. IV (10–1–17 Edition)
Agreement or a CMS finding that the (A) Review of policies, staffing, oper-
hospital has failed to meet the terms of ations, relationship to hospital serv-
the Agreement, CMS makes a final de- ices, and factors that contribute to
termination of whether to approve or program outcomes;
deny a program’s request for Medicare (B) Suggestions for quality improve-
approval or re-approval based on miti- ments the hospital should consider;
gating factors. A Systems Improve- (C) Both verbal and written feedback
ment Agreement follows the process provided directly to the hospital;
specified in paragraph (h) of this sec- (D) Verbal debriefing provided di-
tion. rectly to CMS; neither the hospital nor
(2) Limitation. CMS will not approve the peer review team is required to pro-
any program with a condition-level de- vide a written report to CMS; and
ficiency. However, CMS may approve a (E) Onsite review by a multidisci-
program with a standard-level defi- plinary team that includes a trans-
ciency upon receipt of an acceptable plant surgeon with expertise in the rel-
plan of correction. evant organ type(s), a transplant ad-
(h) Transplant Systems Improvement ministrator, an individual with exper-
Agreement. A Systems Improvement tise in transplant QAPI systems, a so-
Agreement is a binding agreement, en- cial worker or psychologist or psychia-
tered into voluntarily by the hospital trist, and a specialty physician with
and CMS, through which CMS extends expertise in conditions particularly
a prospective Medicare termination relevant to the applicable organ
date and offers the program additional types(s) such as a cardiologist,
time to achieve compliance with the nephrologist, or hepatologist. Except
conditions of participation, contingent for the transplant surgeon, CMS may
on the hospital’s agreement to partici- permit substitution of one type of ex-
pate in a structured regimen of quality pertise for another individual who has
expertise particularly needed for the
improvement activities, demonstrate
type of challenges experienced by the
improved outcomes, and waive the
program, such as substitution of an in-
right to appeal termination based on
fection control specialist in lieu of, or
the identified deficiency or deficiencies
in addition to, a social worker;
(that led to the Agreement) in consid-
(iii) An action plan that addresses
eration for more time to demonstrate
systemic quality improvements and is
compliance. In some cases, transplant
updated after the onsite peer review;
programs may enter a period of inac-
(iv) An onsite consultant whose
tivity—voluntarily, or imposed as a
qualifications are approved by CMS,
condition of the Systems Improvement
and who provides services for 8 days
Agreement. per month on average for the duration
(1) Content. In exchange for the addi- of the agreement, except that CMS
tional time to initiate or continue ac- may permit a portion of the time to be
tivities to achieve compliance with the spent offsite and may agree to fewer
conditions of participation, the hos- consultant days each month after the
pital must agree to a regimen of speci- first 3 months of the Systems Improve-
fied activities, including (but not lim- ment Agreement;
ited to) all of the following: (v) A comparative effectiveness anal-
(i) Patient notification about the de- ysis that compares policies, proce-
gree and type of noncompliance by the dures, and protocols of the transplant
program, an explanation of what the program with those of other programs
program improvement efforts mean for in areas of endeavor that are relevant
patients, and financial assistance to to the center’s current quality im-
defray the out-of-pocket costs of co- provement needs;
payments and testing expenses for any (vi) Development of increased pro-
wait-listed individual who wishes to be ficiency, or demonstration of current
listed with another program; proficiency, with patient-level data
(ii) An external independent peer re- from the Scientific Registry of Trans-
view team that conducts an onsite as- plant Recipients and the use of registry
sessment of the program. The peer re- data to analyze outcomes and inform
view must include— quality improvement efforts;
286
(vii) A staffing analysis that exam- (i) Possesses the necessary profes-
ines the level, type, training, and skill sional qualifications;
of staff in order to inform transplant (ii) Is not precluded from partici-
center efforts to ensure the engage- pating by reason of financial interest
ment and appropriate training and in any such facility or direct responsi-
credentialing of staff; bility for the care of the patients being
(viii) Activities to strengthen per- reviewed or, in the case of a skilled
formance of the Quality Assessment nursing facility, employment by the fa-
and Performance Improvement Pro- cility; and
gram to ensure full compliance with (iii) Is not precluded from effective
the requirements of § 482.96 and § 482.21 participation by the distance between
of this chapter; the facility and his residence, office, or
(ix) Monthly (unless otherwise speci- other place of work. An individual
fied) reporting and conference calls whose residence, office, or other place
with CMS regarding the status of proof work is more than approximately
grammatic improvements, results of one hour’s travel time from the facility
the deliverables in the Systems Im- shall be considered precluded from ef-
provement Agreement, and the number fective participation.
of transplants, deaths, and graft fail- (2) ‘‘Adjacent facility’’ means a
ures that occur within 1 year post- health care facility located within a 50-
transplant; and mile radius of the facility which re-
(x) Additional or alternative require- quests a variance.
ments specified by CMS, tailored to the (b) The Secretary may grant a re-
transplant program type and cir- questing facility a variance from the
cumstances. CMS may waive the con- time frames set forth in §§ 405.1137(d) of
tent elements at paragraphs (h)(1)(v), this chapter and 482.30 as applicable,
(h)(1)(vi), (h)(1)(vii), or (h)(1)(viii) of within which reviews all of cases must
this section if it finds that the program be commenced and completed, upon a
has already adequately conducted the showing satisfactory to the Secretary
activity, the program is already pro- that the requesting facility has been
ficient in the function, or the activity unable to meet one or more of the re-
is clearly inapplicable to the defi- quirements of § 405.1137 of this chapter
ciencies that led to the Agreement. or § 482.30 of this chapter, as applicable,
(2) Timeframe. A Systems Improve- by reason of insufficient medical and
ment Agreement will be established for other professional personnel available
up to a 12-month period, subject to to conduct the utilization review re-
CMS’ discretion to determine if a quired by § 405.1137 of this chapter or
shorter timeframe may suffice. At the § 482.30 of this chapter, as applicable.
hospital’s request, CMS may extend (c) The request for variance shall
the agreement for up to an additional document the requesting facility’s in-
6-month period. A signed Systems Im- ability to meet the requirements for
provement Agreement remains in force which a variance is requested and the
even if a subsequent SRTR report indi- facility’s good faith efforts to comply
cates that the program has restored with the requirements contained in
compliance with the CMS conditions of § 405.1137 of this chapter or § 482.30 of
participation, except that CMS in its this chapter, as applicable.
sole discretion may shorten the time- (d) The request shall include an as-
frame or allow modification to any surance by the requesting facility that
portion of the elements of the Agree- it will continue its good faith efforts to
ment in such a case. meet the requirements contained in
[72 FR 15278, Mar. 30, 2007, as amended at 79 § 405.1137 of this chapter or § 482.30 of
FR 27156, May 12, 2014; 79 FR 50359, Aug. 22, this chapter, as applicable.
2014; 81 FR 79881, Nov. 14, 2016] (e) A revised utilization review plan
for the requesting facility shall be sub-
§ 488.64 Remote facility variances for mitted concurrently with the request
utilization review requirements. for a variance. The revised plan shall
(a) As used in this section: specify the methods and procedures

(1) An ‘‘available’’ individual is one which the requesting facility will use,
who: if a variance is granted, to assure:
287
§ 488.68 42 CFR Ch. IV (10–1–17 Edition)
(1) That effective and timely control for a renewal shall be submitted not
will be maintained over the utilization later than 30 days prior to the expira-
of services; and tion of the variance and shall contain
(2) That reviews will be conducted so all information required by paragraphs
as to improve the quality of care pro- (c), (d), and (f) of this section. Renewal
vided to patients. of the variance will be contingent upon
(f) The request for a variance shall the facility’s continuing to meet the
include: provisions of this section.
(1) The name, location, and type (e.g.,
[40 FR 30818, July 23, 1975. Redesignated at 42
hospital, skilled nursing facility) of the FR 52826, Sept. 30, 1977; 51 FR 22041, June 17,
facility for which the variance is re- 1986; 51 FR 27847, Aug. 4, 1986; 51 FR 43197,
quested; Dec. 1, 1986. Redesignated and amended at 53
(2) The total number of patient ad- FR 23100, June 17, 1988]
missions and average daily patient cen-
sus at the facility within the previous § 488.68 State Agency responsibilities
six months; for OASIS collection and data base
(3) The total number of title XVIII requirements.
and title XIX patient admissions and As part of State agency survey re-
the average daily patient census of sponsibilities, the State agency or
title XVIII and title XIX patients in other entity designated by CMS has
the facility within the previous six overall responsibility for fulfilling the
months; following requirements for operating
(4) As relevant to the request, the the OASIS system:
names of all physicians on the active (a) Establish and maintain an OASIS
staff of the facility and the names of database. The State agency or other en-
all other professional personnel on the tity designated by CMS must—
staff of the facility, or both; (1) Use a standard system developed
(5) The name, location, and type of or approved by CMS to collect, store,
each adjacent facility (e.g., hospital, and analyze data;
skilled nursing facility); (2) Conduct basic system manage-
(6) The distance and average travel ment activities including hardware and
time between the facility and each ad- software maintenance, system back-up,
jacent facility; and monitoring the status of the data-
(7) As relevant to the request, the lo- base; and
cation of practice of available physi- (3) Obtain CMS approval before modi-
cians and the estimated number of fying any parts of the CMS standard
other available professional personnel, system including, but not limited to,
or both (see paragraph (a)(1)(iii) of this standard CMS-approved—
section); (i) OASIS data items;
(8) Documentation by the facility of (ii) Record formats and validation
its attempt to obtain the services of edits; and
available physicians or other profes- (iii) Agency encoding and trans-
sional personnel, or both; and mission methods.
(9) A statement of whether a QIO ex- (b) Analyze and edit OASIS data. The
ists in the area where the facility is lo- State agency or other entity des-
cated. ignated by CMS must—
(g) The Secretary shall promptly no- (1) Upon receipt of data from an
tify the facility of the action taken on HHA, edit the data as specified by CMS
the request. Where a variance is in ef- and ensure that the HHA resolves er-
fect, the validation of utilization re- rors within the limits specified by
view pursuant to § 405.1137 of this chap- CMS;
ter or § 482.30 shall be made with ref- (2) At least monthly, make available
erence to the revised utilization review for retrieval by CMS all edited OASIS
plan submitted with the request for records received during that period, ac-
variance. cording to formats specified by CMS,
(h) The Secretary, in granting a vari- and correct and retransmit previously
ance, will specify the period for which rejected data as needed; and
the variance has been granted; such pe- (3) Analyze data and generate reports
riod will not exceed one year. A request as specified by CMS.
288
(c) Ensure accuracy of OASIS data. gration of the OASIS data set into the
The State agency must audit the accu- facility’s own record keeping system;
racy of the OASIS data through the (2) Instruct each HHA on the use of
survey process. software to encode and transmit OASIS
(d) Restrict access to OASIS data. The data to the State;
State agency or other entity des- (3) Specify to a facility the method of
ignated by CMS must do the following: transmission of data to the State, and
(1) Ensure that access to data is re- instruct the facility on this method.
stricted except for the transmission of
(4) Monitor each HHA’s ability to
data and reports to—
transmit OASIS data.
(i) CMS;
(ii) The State agency component that (5) Provide ongoing technical assist-
conducts surveys for purposes related ance and general support to HHAs in
to this function; and implementing the OASIS reporting re-
(iii) Other entities if authorized by quirements specified in the conditions
CMS. of participation for home health agen-
(2) Ensure that patient identifiable cies; and
OASIS data is released only to the ex- (6) Carry out any other functions as
tent that it is permitted under the Pri- designated by CMS necessary to main-
vacy Act of 1974. tain OASIS data on the standard State
(e) Provide training and technical sup- system.
port for HHAs. The State agency or
[64 FR 3763, Jan. 25, 1999]
other entity designated by CMS must—
(1) Instruct each HHA on the admin-
istration of the data set, privacy/con- Subpart C—Survey Forms and
fidentiality of the data set, and inte- Procedures
289
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
§ 488.100 Long term care survey forms, Part A.

290
EC01JA91.016</GPH>
291
EC01JA91.017</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
292
EC01JA91.018</GPH>
293
EC01JA91.019</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
294
EC01JA91.020</GPH>
295
EC01JA91.021</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
296
EC01JA91.022</GPH>
297
EC01JA91.023</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
298
EC01JA91.024</GPH>
299
EC01JA91.025</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
300
EC01JA91.026</GPH>
301
EC01JA91.027</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
302
EC01JA91.028</GPH>
303
EC01JA91.029</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
304
EC01JA91.030</GPH>
305
EC01JA91.031</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
306
EC01JA91.032</GPH>
307
EC01JA91.033</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
308
EC01JA91.034</GPH>
309
EC01JA91.035</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
310
EC01JA91.036</GPH>
311
EC01JA91.037</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
312
EC01JA91.038</GPH>
313
EC01JA91.039</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
314
EC01JA91.040</GPH>
315
EC01JA91.041</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
316
EC01JA91.042</GPH>
317
EC01JA91.043</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
318
EC01JA91.044</GPH>
319
EC01JA91.045</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
320
EC01JA91.046</GPH>
321
EC01JA91.047</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
322
EC01JA91.048</GPH>
323
EC01JA91.049</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
324
EC01JA91.050</GPH>
325
EC01JA91.051</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
326
EC01JA91.052</GPH>
327
EC01JA91.053</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
328
EC01JA91.054</GPH>
329
EC01JA91.055</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
330
EC01JA91.056</GPH>
331
EC01JA91.057</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
332
EC01JA91.058</GPH>
333
EC01JA91.059</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
334
EC01JA91.060</GPH>
335
EC01JA91.061</GPH>
§ 488.100 42 CFR Ch. IV (10–1–17 Edition)
336
EC01JA91.062</GPH>
337
EC01JA91.063</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
§ 488.105 Long term care survey forms, Part B.

338
EC01JA91.064</GPH>
339
EC01JA91.065</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
340
EC01JA91.066</GPH>
341
EC01JA91.067</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
342
EC01JA91.068</GPH>
343
EC01JA91.069</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
344
EC01JA91.070</GPH>
345
EC01JA91.071</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
346
EC01JA91.072</GPH>
347
EC01JA91.073</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
348
EC01JA91.074</GPH>
349
EC01JA91.075</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
350
EC01JA91.076</GPH>
351
EC01JA91.077</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
352
EC01JA91.078</GPH>
353
EC01JA91.079</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
354
EC01JA91.080</GPH>
355
EC01JA91.081</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
356
EC01JA91.082</GPH>
357
EC01JA91.083</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
358
EC01JA91.084</GPH>
359
EC01JA91.085</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
360
EC01JA91.086</GPH>
361
EC01JA91.087</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
362
EC01JA91.088</GPH>
363
EC01JA91.089</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
364
EC01JA91.090</GPH>
365
EC01JA91.091</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
366
EC01JA91.092</GPH>
367
EC01JA91.093</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
368
EC01JA91.094</GPH>
369
EC01JA91.095</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
370
EC01JA91.096</GPH>
371
EC01JA91.097</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
372
EC01JA91.098</GPH>
373
EC01JA91.099</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
374
EC01JA91.100</GPH>
375
EC01JA91.101</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
376
EC01JA91.102</GPH>
377
EC01JA91.103</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
378
EC01JA91.104</GPH>
379
EC01JA91.105</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
380
EC01JA91.106</GPH>
381
EC01JA91.107</GPH>
§ 488.105 42 CFR Ch. IV (10–1–17 Edition)
382
EC01JA91.108</GPH>
§ 488.110 Procedural guidelines. resident, is actually being provided in

nursing homes. Although the onsite re-
SNF/ICF Survey Process. The purpose
view procedures have been changed, fa-
for implementing a new SNF/ICF sur-
cilities must continue to meet all ap-
vey process is to assess whether the

plicable Conditions/Standards, in order
quality of care, as intended by the law to participate in Medicare/Medicaid
and regulations, and as needed by the programs. That is, the methods used to
383
EC01JA91.109</GPH>
§ 488.110 42 CFR Ch. IV (10–1–17 Edition)
compile information about compliance CMS–519), along with the related work-
with law and regulations are changed; sheets (CMS–520 through 524).
the law and regulations themselves are Use this survey process for all sur-
not changed. The new process differs veys of SNFs and ICFs—whether free-
from the traditional process, prin- standing, distinct parts, or dually cer-
cipally in terms of its emphasis on resi- tified. Do not use this process for sur-
dent outcomes. In ascertaining wheth- veys of Intermediate Care Facilities for
er residents grooming and personal hy- Mentally Retarded (ICFs/IID), swing-
giene needs are met, for example, sur- bed hospitals or skilled nursing sec-
veyors will no longer routinely evalu- tions of hospitals that are not sepa-
ate a facility’s written policies and rately certified as SNF distinct parts.
procedures. Instead, surveyors will ob- Do not announce SNF/ICF surveys
serve residents in order to make that ahead of time.
determination. In addition, surveyors (b) The Survey Tasks. Listed below are
will confirm, through interviews with the survey tasks for easy reference:
residents and staff, that such needs are • Task 1. Entrance Conference.
indeed met on a regular basis. In most • Task 2. Resident Sample—Selection
reviews, then, surveyors will ascertain Methodology.
whether the facility is actually pro- • Task 3. Tour of the Facility. Resi-
viding the required and needed care dent Needs. Physical Environment.
and services, rather than whether the Meeting with Resident Council Rep-
facility is capable of providing the care resentatives. Tour Summation and
and services. Focus of Remaining Survey Activity.
• Task 4. Observation/Interview/Med-
THE OUTCOME-ORIENTED SURVEY PROCESS— ical Record. Review of Each Individual
SKILLED NURSING FACILITIES (SNFS) AND
INTERMEDIATE CARE FACILITIES (ICFS)
in the Resident Sample (including drug
regimen review).
(a) General. • Task 5. Drug Pass Observation.
(b) The Survey Tasks. • Task 6. Dining Area and Eating As-
(c) Task 1—Entrance Conference. sistance Observation.
(d) Task 2—Resident Sample—Selection
• Task 7. Forming the Deficiency
Methodology.
(e) Task 3—Tour of the Facility.
Statement (if necessary).
(f) Task 4—Observation/Interview/Medical • Task 8. Exit Conference.
Record Review (including drug regimen re- (c) Task 1—Entrance Conference. Per-
view). form these activities during the en-
(g) Task 5—Drug Pass Observation. trance conference in every certifi-
(h) Task 6—Dining Area and Eating Assist- cation and recertification survey:
ance Observation. • Introduce all members of the team
(i) Task 7—Forming the Deficiency State- to the facility staff, if possible, even
ment. though the whole team may not be
(j) Task 8—Exit Conference.
present for the entire entrance con-
(k) Plan of Correction.
(l) Followup Surveys. ference. (All surveyors wear identifica-
(m) Role of Surveyor. tion tags.)
(n) Confidentiality and Respect for Resi- • Explain the SNF/ICF survey proc-
dent Privacy. ess as resident centered in focus, and
(o) Team Composition. outline the basic steps.
(p) Type of Facility-Application of SNF or • Ask the facility for a list showing
ICF Regulations. names of residents by room number
(q) Use of Part A and Part B of the Survey with each of the following care needs/
Report. treatments identified for each resident
(a) General. A complete SNF/ICF fa- to whom they apply:
cility survey consists of three compo- —Decubitus care
nents: —Restraints
• Life Safety Code requirements; —Catheters
• Administrative and structural re- —Injections
quirements (Part A of the Survey Re- —Parenteral fluids
port, Form CMS–525); and —Rehabilitation service

• Direct resident care requirements —Colostomy/ileostomy care
(Part B of the Survey Report, Form —Respiratory care
384
—Tracheostomy care Number of

residents in Number of residents in sample 1
—Suctioning facility
—Tube feeding
0–60 resi- 25% of residents (minimum—10).
Use this list for selecting the residents.
dent sample. 61–120 20% of residents (minimum—15).
residents.
• Ask the facility to complete page 2 121–200 15% of residents (minimum—24).
of Form CMS–519 (Resident Census) as residents.
soon as possible, so that the informa- 201 + resi- 10% of residents (minimum—30).
dents.
tion can further orient you to the fa-
1 Maximum—50.
cility’s population. In a survey of a
SNF with a distinct part ICF, you may Note that the calculation is based on
collect two sets of census data. How- the resident census, not beds. After de-
ever, consolidate the information when termining the appropriate sample size,
submitting it to the regional office. select residents for the sample in a ran-
You may modify the Resident Census dom manner. You may, for example, se-
Form to include the numbers of li- lect every fifth resident from the resi-
censed and certified beds, if necessary. dent census, beginning at a random po-
• Ask the facility to post signs on sition on the list. For surveys of dually
readily viewed areas (at least one on certified facilities or distinct part
each floor) announcing that State sur- SNFs/ICFs, first use the combined SNF/
veyors are in the facility performing an ICF population to calculate the size of
‘‘inspection,’’ and are available to meet the sample, and then select a sample
with residents in private. Also indicate that reflects the proportions of SNF
the name and telephone number of the and ICF residents in the facility’s over-
State agency. Hand-printed signs with all population.
(2) Special Care Needs/Treatments. The
legible, large letters are acceptable.
survey form specifies several care
• If the facility has a Resident Coun- needs/treatments that must always be
cil, make mutually agreeable arrange- reviewed when they apply to any facil-
ments to meet privately with the presi- ity residents. These include:
dent and officers and other individuals
• Decubitus Care
they might invite.
• Restraints
• Inform the facility that interviews • Catheters
with residents and Resident Councils • Injections, Parenteral Fluids, Colos-
are conducted privately, unless they tomy/Ileostomy, Respiratory Care,
independently request otherwise, in Tracheostomy Care, Suctioning,
order to enhance the development of Tube Feeding
rapport as well as to allay any resident • Rehabilitative Services (physical
anxiety. Tell the facility that informa- therapy, speech pathology and audi-
tion is gathered from interviews, the ology services, occupational therapy)
tour, observations, discussions, record Due to the relatively low prevalence
review, and facility officials. Point out of these care needs/treatments, appro-
that the facility will be given an oppor- priate residents may be either under-
tunity to respond to all findings. represented or entirely omitted from
(d) Task 2—Resident Sample—Selection the sample. Therefore, determine dur-
Methodology. This methodology is ing the tour how many residents in the
aimed at formulating a sample that re- random selection fall into each of these
flects the actual distribution of care care categories. Then, compare the
needs/treatments in the facility popu- number of such residents in the ran-
lation. dom selection with the total number of
Primarily performed on a random residents in the facility with each spec-
basis, it also ensures representation in ified care need/treatment (based on ei-
the sample of certain care needs and ther the resident census or other infor-
treatments that are assessed during mation provided by the facility).
the survey. Review no less than 25 percent of the
(1) Sample Size. Calculate the size of residents in each of these special care
the sample according to the following needs/treatments categories. For exam-
guide: ple, if the facility has 10 residents with
385
§ 488.110 42 CFR Ch. IV (10–1–17 Edition)
decubitus ulcers, but only one of these ily members/significant others (if
residents is selected randomly, review present), and staff, asking open-ended
two more residents with decubitis ul- questions in order to confirm observa-
cers (25% of 10 equals 2.5, so review a tions, obtain additional information, or
total of 3). Or, if the facility has two corroborate information, (e.g., acci-
residents who require tube feeding, nei- dents, odors, apparent inappropriate
ther of whom is in the random selec- dress, adequacy and appropriateness of
tion, review the care of at least one of activities). Converse sufficiently with
the these residents. This can be accom- residents selected for in-depth review
plished in the following manner: to ascertain whether they are willing
Conduct in-depth reviews of the ran- to be interviewed and are communica-
domly selected residents and then per- tive. Observe staff interactions with
form limited reviews of additional resi- other staff members as well as with
dents as needed to cover the specified residents for insight into matters such
care categories. Such reviews are lim- as resident rights and assignments of
ited to the care and services related to staff responsibilities.
the pertinent care areas only, e.g., Always knock and/or get permission
catheters, restraints, or colostomy. before entering a room or interrupting
Utilize those worksheets or portions of privacy. If you wish to inspect a resi-
worksheets which are appropriate to dent’s skin, observe a treatment proce-
the limited review. Refer to the Care dure, or observe a resident who is ex-
Guidelines, as a resource document, posed, courteously ask permission from
when appropriate. the resident if she/he comprehends, or
Always keep in mind that neither the ask permission from the staff nurse if
random selection approach nor the re- the resident cannot communicate. Do
view of residents within the specified not do ‘‘hands-on’’ monitoring such as
care categories precludes investigation removal of dressings; ask staff to re-
of other resident care situations that move a dressing or handle a resident.
you believe might pose a serious threat (3) Resident Needs. While touring,
to a resident’s health or safety. Add to focus on the residents’ needs—physical,
the sample, as appropriate. emotional, psychosocial, or spiritual—
(e) Task 3—Tour of the Facility—(1) and whether those needs are being met.
Purpose. Conduct the tour in order to: Refer to the following list as needed:
• Develop an overall picture of the —Personal hygiene, grooming, and ap-
types and patterns of care delivery propriate dress
present within the facility; —Position
• View the physical environment; —Assistive and other restorative de-
and vices
• Ascertain whether randomly se- —Rehabilitation issues
lected residents are communicative —Functional limitations in ADL
and willing to be interviewed. —Functional limitations in gait, bal-
(2) Protocol. You may tour the entire ance and coordination
facility as a team or separately, as —Hydration and nutritional status
long as all areas of the facility are ex- —Resident rights
amined by at least one team member. —Activity for time of day (appropriate
Success of the latter approach, how- or inappropriate)
ever, is largely dependent on open —Emotional status
intra-team communication and the —Level of orientation
ability of each team member to iden- —Awareness of surroundings
tify situations for further review by —Behaviors
the team member of the appropriate —Cleanliness of immediate environ-
discipline. You may conduct the tour ment (wheelchair, bed, bedside table,
with or without facility staff accom- etc.)
panying you, as you prefer. Facilities, —Odors
however, vary in staff member avail- —Adequate clothing and care supplies
ability. Record your notes on the Tour as well as maintenance and cleanli-
Notes Worksheet, Form CMS–521. ness of same

Allow approximately three hours for (4) Review of the Physical Environment.
the tour. Converse with residents, fam- As you tour each resident’s room and
386
auxiliary rooms, also examine them in • ‘‘What don’t you like? What do you
connection with the physical environ- like?’’
ment requirements. You need not docu- (6) Tour Summation and Focus of Re-
ment physical environment on the maining Survey Activity. When the tour
Tour Notes Worksheet. Instead, you is completed, review the resident cen-
may note any negative findings di- sus data provided by the facility. De-
rectly on the Survey Report Form in termine if the care categories specified
the remarks section. in the section on Resident Sample are
(5) Meeting With Resident Council Rep- sufficiently represented in the random
resentatives. If a facility has a Resident selection, make adjustments as needed,
Council, one or more surveyors meet and complete the listing of residents on
with the respresentatives in a private the worksheet labeled ‘‘Residents Se-
area. Facility staff members do not at- lected for In-depth Review’’, Form
tend unless specifically requested by CMS–520.
the Council. Explain the purpose of the Transcribe notes of a negative nature
survey and briefly outline the steps in onto the SRF in the ‘‘Remarks’’ col-
the survey process, i.e., entrance con- umn under the appropriate rule. Find-
ference * * * exit conference. Indicate ings from a later segment in the survey
your interest in learning about the or gathered by another surveyor may
strengths of the facility in addition to combine to substantiate a deficiency.
any complaints or shortcomings. State You need not check ‘‘met’’ or ‘‘not
that this meeting is one part of the in- met’’ at this point in the survey. Dis-
formation gathering; the findings have cuss significant impressions/conclu-
not yet been completed nor the conclusions at the completion of each subse-
sions formulated. Explain further, how- quent survey task, and transfer any
ever, that the official survey findings negative findings onto the Survey Re-
are usually available within three port Form in the Remarks section.
months after the completion of the sur- (f) Task 4—Observation/Interview/Med-
vey, and give the telephone number of ical Record Review (including drug regi-
the State agency office. men review). Perform the in-depth re-
Use this meeting to ascertain view of each individual in the resident
strengths and/or problems, if any, from sample in order to ascertain whether
the consumer’s perspective, as well as the facility is meeting resident needs.
to develop additional information Evaluate specific indicators for each
about aspects of care and services resident, utilizing the front and back of
gleaned during the tour that were pos- the ‘‘Observation/Interview/Record Re-
sibly substandard. view (OIRR)’’ worksheet, Form CMS–
Conduct the meeting in a manner 524. You may prefer to perform the
that allows for comments about any record review first, complete resident/
aspect of the facility. (See the section staff/family observations and inter-
on Interview Procedures.) Use open- views, and finally, return to the record
ended questions such as: for any final unresolved issues. On the
• ‘‘What is best about this home?’’ other hand, you may prefer to do the
• ‘‘What is worst?’’ interviews first. Either method is ac-
• ‘‘What would you like to change?’’ ceptable. Whenever possible, however,
In order to get more detail, use ques- complete one resident’s observation/
tions such as: interview/medical record review and
document the OIRR before moving
• ‘‘Can you be more specific?’’ onto another resident. If because of the
• ‘‘Can you give me an example?’’
facility layout, it is more efficient to
• ‘‘What can anyone else tell me
do more than one record review at a
about this?’’
time, limit such record review to two
If you wish to obtain information or three residents so your familiarity
about a topic not raised by the resi- with the particular resident and con-
dents, use an approach like the fol- tinuity of the OIRR are not com-
lowing: promised.
• ‘‘Tell me what you think about the (1) Observation. Conduct observations
food/staff/cleanliness here.’’ concurrently with interviews of resi-
• ‘‘What would make it better?’’ dents, family/significant others, and
387
§ 488.110 42 CFR Ch. IV (10–1–17 Edition)
discussions with direct care staff [of • Assure that you will strive for ano-
the various disciplines involved. In nymity for the resident and that the
multi-facility operations, whenever interview is used in addition to med-
possible, observe staff that is regularly ical records, observations, discussions,
assigned to the facility in order to gain etc., to capture an accurate picture of
an understanding of the care and serv- the treatment and care provided by the
ices usually provided.] Maintain re- facility. Explain that the official find-
spect for resident privacy. Minimize ings of the survey are usually available
disruption of the operations of the fa- to the public about three months after
cility or impositions upon any resident completion of the survey, but resident
as much as possible. Based upon your names are not given to the public.
observations of the residents’ needs, • When residents experience dif-
gather information about any of the ficulty expressing themselves:
following areas, as appropriate: —Avoid pressuring residents to ver-
Bowel and bladder training balize
Catheter care —Accept and respond to all commu-
Restraints nication
Injections —Ignore mistakes in word choice
Parenteral fluids —Allow time for recollection of words
Tube feeding/gastrostomy
—Encourage self-expression through
Colostomy/ileostomy any means available
Respiratory therapy
Tracheostomy care • When interviewing residents with
Suctioning decreased receptive capacity:
(2) Interviews. Interview each resident —Speak slowly and distinctly
in private unless he/she independently —Speak at conversational voice level
requests that a facility staff member or —Sit within the resident’s line of vi-
other individual be present. Conduct sion
the in-depth interview in a nonthreat- • Listen to all resident information/al-
ening and noninvasive fashion so as to legations without judgment. Infor-
decrease anxiety and defensiveness. mation gathered subsequently may
The open-ended approach described in substantiate or repudiate an allega-
the section on the Resident Council is tion.
also appropriate for the in-depth inter- The length of the interview varies,
view. While prolonged time expendi- depending on the condition and wishes
ture is not usually a worthwhile use of of the resident and the amount of in-
resources or the resident’s time, do formation supplied. Expect the average
allow time initially to establish rap- interview, however, to last approxi-
port. mately 15 minutes. Courteously termi-
At each interview: nate an interview whenever the resi-
• Introduce yourself. dent is unable or unwilling to continue,
• Address the resident by name. or is too confused or disoriented to
• Explain in simple terms the reason continue. Do, however, perform the
for your visit (e.g., to assure that the other activities of this task (observa-
care and services are adequate and ap- tion and record review). If, in spite of
propriate for each resident). your conversing during the tour, you
• Briefly outline the process—en- find that less than 40 percent of the
trance conference, tour, interviews, ob- residents in your sample are suffi-
servations, review of medical records, ciently alert and willing to be inter-
resident interviews, and exit con- viewed, try to select replacements so
ference. that a complete OIRR is performed for
• Mention that the selection of a par- a group this size, if possible. There may
ticular resident for an interview is not be situations, however, where the resi-
meant to imply that his/her care is dent population has a high percentage
substandard or that the facility proof confused individuals and this per-
vides substandard care. Also mention centage is not achievable. Expect that
that most of those interviewed are se- the information from confused individ-
lected randomly. uals can be, but is not necessarily, less
388
reliable than that from more alert indi- • The interventions have been car-
viduals. ried out.
Include the following areas in the • The resident has been evaluated to
interview of each resident in the sam- determine the effectiveness of the
ple: interventions.
Activities of daily living For example, if a resident has devel-
Grooming/hygiene oped a decubitus ulcer while in the fa-
Nutrition/dietary cility, record review can validate staff
Restorative/rehabilitation care and and resident interviews regarding the
services facility’s attempts at prevention. Use
Activities your own judgment; review as much of
Social services the record(s) as necessary to evaluate
Resident rights the care planning. Note that facilities
need not establish specific areas in the
Refer to the Care Guidelines ‘‘eval-
record stating ‘‘Assessment,’’ ‘‘Plan,’’
uation factors’’ as a resource for pos-
‘‘Intervention,’’ or ‘‘Evaluation’’ in
sible elements to consider when focus-
order for the documentation to be con-
ing on particular aspects of care and
sidered adequate.
resident needs.
(ii) Reconciling the record with itself.
Document information obtained from Determine:
the interviews/observations on the
OIRR Worksheet. Record in the • If the resident has been properly as-
‘‘Notes’’ section any additional infor- sessed for all his/her needs.
mation you may need in connection • That normal and routine nursing
with substandard care or services. Un- practices such as periodic weights,
less the resident specifically requests temperatures, blood pressures, etc., are
that he/she be identified, do not reveal performed as required by the resident’s
the source of the information gleaned conditions.
from the interview. (iii) Performing the drug regimen re-
(3) Medical Record Review. The med- view. The purpose of the drug regimen
ical record review is a three-part proc- review is to determine if the phar-
ess, which involves first reconciling the macist has reviewed the drug regimen
observation/interview findings with the on a monthly basis. Follow the proce-
record, then reconciling the record dures in Part One of Appendix N, Sur-
against itself, and lastly performing veyor Procedures for Pharmaceutical
the drug regimen review. Service Requirements in Long-Term
Document your findings on the OIRR Care Facilities. Fill in the appropriate
Worksheet, as appropriate, and summa- boxes on the top left hand corner of the
rize on the Survey Report Form the reverse side of the OIRR Worksheet,
findings that are indicative of problem- Form CMS–524. Appendix N lists many
atic or substandard care. Be alert for irregularities that can occur. Review
repeated similar instances of sub- at least six different indicators on each
standard care developing as the num- survey. However, the same six indica-
ber of completed OIRR Worksheets in- tors need not be reviewed on every sur-
creases. vey.
NOTE: The problems related to a particular NOTE: If you detect irregularities and the
standard or condition could range from iden- documentation demonstrates that the phar-
tical (e.g., meals not in accordance with die- macist has notified the attending physician,
tary plan) to different but related (e.g., nurs- do not cite a deficiency. Do, however, bring
ing services—lapse in care provided to resi- the irregularity to the attention of the med-
dents with catheters, to residents with con- ical director or other facility official, and
tractures, to residents needing assistance for note the official’s name and date of notifica-
personal hygiene and residents with improp- tion on the Survey Report Form.
erly applied restraints). (g) Task 5—Drug Pass Observation. The
purpose of the drug pass observation is
(i) Reconciling the observation/interview to observe the actual preparation and
findings with the record. Determine if: administration of medications to resi-
• An assessment has been performed. dents. With this approach, there is no

• A plan with goals has been devel- doubt that the errors detected, if any,
oped. are errors in drug administration, not
389
§ 488.110 42 CFR Ch. IV (10–1–17 Edition)
documentation. Follow the procedure help alleviate resident anxiety over the
in Part Two of Appendix N, Surveyor observation process.
Procedures for Pharmaceutical Service Select a minimum of five residents
Requirements in Long-Term Care Fa- for each meal observation and include
cilities, and complete the Drug Pass residents who have their meals in their
Worksheet, Form CMS–522. Be as neu- rooms. Residents selected for the in-
tral and unobtrusive as possible during depth review need not be included in
the drug pass observation. Whenever the dining and eating assistance obser-
possible, select one surveyor, who is a vation; however, their whole or partial
Registered Nurse or a pharmacist, to inclusion is acceptable. Ascertain the
observe the drug pass of approximately extent to which the facility assesses,
20 residents. In facilities where fewer plans, and evaluates the nutritional
than 20 residents are receiving medica- care of residents and eating assistance
tions, review as many residents receiv- needs by reviewing the sample of 10 or
ing medications as possible. Residents more residents. If you are unable to de-
selected for the in-depth review need termine whether the facility meets the
not be included in the group chosen for standards from the sample reviewed,
the drug pass; however, their whole or expand the sample and focus on the
partial inclusion is acceptable. In order specific area(s) in question, until you
to get a balanced view of a facility’s can formulate a conclusion about the
practices, observe more than one per- extent of compliance. As with the
son administering a drug pass, if fea- other survey tasks, transfer the find-
sible. This might involve observing the
ings noted on the ‘‘Dining & Eating As-
morning pass one day in Wing A, for
sistance Observation’’ worksheet to the
example, and the morning pass the
Survey Report Form.
next day in Wing B.
Transfer findings noted on the ‘‘Drug (i) Task 7—Forming the Deficiency
Pass’’ worksheet to the SRF under the Statement—(1) General. The Survey Re-
appropriate rule. If your team con- port Form contains information about
cludes that the facility’s medication all of the negative findings of the sur-
error rate is 5 percent or more, cite the vey. Be sure to transfer to the Survey
deficiency under Nursing Services/Ad- Report Form data from the tour, drug
ministration of Drugs. Report the error pass observation, dining area and eat-
rate under F209. If the deficiency is at ing assistance observation, as well as
the standard level, cite it in Nursing in-depth review of the sample of resi-
Services, rather than Pharmacy. dents. Transfer only those findings
(h) Task 6—Dining Area and Eating As- which could possibly contribute to a
sistance Observation. The purpose of this determination that the facility is defi-
task is to ascertain the extent to which cient in a certain area.
the facility meets dietary needs, par- Meet as a group in a pre-exit con-
ticularly for those who require eating ference to discuss the findings and
assistance. This task also yields infor- make conclusions about the defi-
mation about staff interaction with ciencies, subject to information pro-
residents, promptness and appropriate- vided by facility officials that may fur-
ness of assistance, adaptive equipment ther explain the situation. Review the
usage and availability, as well as ap- summaries/conclusions from each task
propriateness of dress and hygiene for and decide whether any further infor-
meals. mation and/or documentation is nec-
For this task, use the worksheet en- essary to substantiate a deficiency. As
titled ‘‘Dining Area and Eating Assist- the facility for additional information
ance Observation’’ (Form CMS–523). for clarification about particular find-
Observe two meals; for a balanced view, ings, if necessary. Always consider in-
try to observe meals at different times formation provided by the facility. If
of the day. For example, try to observe the facility considers as acceptable,
a breakfast and a dinner rather than practices which you believe are not ac-
two breakfasts. Give particular care to ceptable, ask the facility to backup its
performing observations as unobtru- contention with suitable reference ma-

sively as possible. Chatting with resi- terial or sources and submit them for
dents and sitting down nearby may your consideration.
390
(2) Analysis. Analyze the findings on ascertain compliance, and cite accord-
the Survey Report Form for the degree ingly. Residents, family, or former em-
of severity, frequency of occurrence ployees may be helpful for information
and impact on delivery of care or qual- gathering.
ity of life. The threshold at which the (4) Composing the Deficiency Statement.
frequency of occurrences amounts to a Write the deficiency statement in
deficiency varies from situation to sit- terms specific enough to allow a rea-
uation. One occurrence directly related sonably knowledgeable person to un-
to a life-threatening or fatal outcome derstand the aspect(s) of the require-
can be cited as a deficiency. On the ment(s) that is (are) not met. Do not
other hand, a few sporadic occurrences delve into the facility’s policies and
may have so slight an impact on deliv- procedures to determine or speculate
ery of care or quality of life that they on the root cause of a deficiency, or
do not warrant a deficiency citation. sift through various alternatives in an
Review carefully all the information effort to prescribe an acceptable rem-
gathered. What may appear during ob- edy. Indicate the data prefix tag and
servation as a pattern, may or may not regulatory citation, followed by a sum-
be corroborated by records, staff, and mary of the deficiency and supporting
residents. For example, six of the 32 findings using resident identifiers, not
residents in the sample are dressed in resident names, as in the following ex-
mismatched, poorly buttoned clothes. ample.
A few of the six are wearing slippers F102 SNF 405.1123(b).—Each resident has
without socks. A few others are wear- not had a physician’s visit at least once
ing worn clothes. Six occurrences every 30 days for the first 90 days after ad-
might well be indicative of a pattern of mission. Resident #1602 has not been seen by
susbstandard care. Close scrutiny of a physician since she was admitted 50 days
records, discussions with staff, and ago. Her condition has deteriorated since
interviews reveal, however, that the six that time (formulation of decubiti, infec-
tions).
residents are participating in dressing
retraining programs. Those residents When the data prefix tag does not re-
who are without socks, chose to do so. peat the regulations, also include a
The worn clothing items were also cho- short phrase that describes the prefix
sen—they are favorites. tag (e.g., F117 decubitus ulcer care).
Combinations of substandard care List the data tags in numerical order,
such as poor grooming of a number of whenever possible.
residents, lack of ambulation of a num- (j) Task 8—Exit Conference. The pur-
ber of residents, lack of attention to pose of the exit conference is to inform
positioning, poor skin care, etc., can the facility of survey findings and to
yield a deficiency in nursing services arrange for a plan of correction, if
just as 10 out of 10 residents receiving needed. Keep the tone of the exit con-
substandard care for decubiti yields a ference consistent with the character
deficiency. of the survey process—inspection and
(3) Deficiencies Alleged by Staff or Resi- enforcement. Tactful, business-like,
dents. If staff or residents allege defi- professional presentation of the find-
ciencies, but records, interviews, and ings is of paramount importance. Rec-
observation fail to confirm the situa- ognize that the facility may wish to re-
tion, it is unlikely that a deficiency ex- spond to various findings. Although de-
ists. Care and services that are indeed ficiency statements continue to de-
confirmed by the survey to be in com- pend, in part, on surveyor professional
pliance with the regulatory require- judgment, support your conclusions
ments, but considered deficient by resi- with resident-specific examples (identi-
dents or staff, cannot be cited as defi- fiers other than names) whenever you
cient for certification purposes. On the can do so without compromising con-
other hand, if an allegation is of a very fidentiality. Before formally citing de-
serious nature (e.g., resident abuse) ficiencies, discuss any allegations or
and the tools of record review and ob- findings that could not be substan-
servation are not effective because the tiated during earlier tasks in the proc-
problem is concealed, obtain as much ess. For example, if information is
information as possible or necessary to gathered that suggests a newly hired
391
§ 488.110 42 CFR Ch. IV (10–1–17 Edition)
R.N. is not currently licensed, ask the day,’’ is not acceptable. An acceptable
facility officials to present current li- plan of correction would explain
censure information for the nurse in changes made to the facility’s staffing
question. Identify residents when the and scheduling in order to gurantee
substandard care is readily observed or that staff is available to provide all
discerned through record review. En- necessary services for all residents.
sure that the facility improves the care Acceptance of the plan of correction
provided to all affected residents, not does not absolve the facility of the re-
only the identified residents. Make sponsibility for compliance should the
clear to the facility that during a fol- implementation not result in correc-
low-up visit the surveyors may review tion and compliance. Acceptance indi-
residents other than those with signifi- cates the State agency’s acknowledge-
cant problems from the original sam- ment that the facility indicated a will-
ple, in order to see that the facility has ingness and ability to make correc-
corrected the problems overall. Do not tions adequately and timely.
disclose the source of information pro-
Allow the facility up to 10 days to
vided during interviews, unless the
prepare and submit the plan of correc-
resident has specifically requested you
tion to the State agency, however, fol-
to inform the facility of his/her com-
ments or complaints. In accordance low your SA policy if the timeframe is
with your Agency’s policy, present the shorter. Retain the various survey
Statement of Deficiencies, form CMS– worksheets as well as the Survey Re-
2567, on site or after supervisory report Form at the State agency. For-
view, no later than 10 calendar days ward the deficiency statement to the
following the survey. CMS regional office.
(k) Plan of Correction. Explain to the (l) Follow-up Surveys. The purpose of
facility that your role is to identify the follow-up survey is to re-evaluate
care and services which are not con- the specific types of care or care deliv-
sistent with the regulatory require- ery patterns that were cited as defi-
ments, rather than to ascertain the cient during the original survey. Ascer-
root causes of deficiencies. Each facil- tain the corrective status of all defi-
ity is expected to review its own care ciencies cited on the CMS–2567. Be-
delivery. Subsequent to the exit con- cause this survey process focuses on
ference, each facility is required to the actual provision of care and serv-
submit a plan of correction that identi- ices, revisits are almost always nec-
fies necessary changes in operation essary to ascertain whether the
that will assure correction of the cited deficienicies have indeed been cor-
deficiencies. In reviewing and accept- rected. The nature of the deficiencies
ing a proposed plan of correction, apply dictates the scope of the follow-up
these criteria: visit. Use as many tasks or portions of
• Does the facility have a reasonable the Survey Report Form(s) as needed
approach for correcting the defi- to ascertain compliance status. For ex-
ciencies? ample, you need not perform another
• Is there a high probability that the drug pass if no drug related deficiencies
planned action will result in compli- were cited on the initial survey. Simi-
ance? larly, you need not repeat the dining
• Is compliance expected timely? area and eating assistance observations
Plans of correction specific to resi- if no related problems were identified.
dents identified on the deficiency All or some of the aspects of the obser-
statement are acceptable only where vation/interview/medical record review,
the deficiency is determined to be however, are likely to be appropriate
unique to that resident and not indic- for the follow-up survey.
ative of a possible systemic problem. When selecting the resident sample
For example, as a result of an aide for the follow-up, determine the sample
being absent, two residents are not am- size using the same formula as used
bulated three times that day as called earlier in the survey, with the fol-
for in their care plans. A plan of cor- lowing exceptions:

rection that says ‘‘Ambulate John • The maximum sample size is 30
Jones and Mary Smith three times per residents, rather than 50.
392
• The minimum sample size of 10 ensure that the restriants are applied
residents does not apply if only one properly.
care category was cited as deficient A secondary role for the surveyor is
and the total number of residents in to provide general consultation to the
the facility in that category was less provider/consumer community. This in-
than 10 (e.g., deficiency cited under cludes meeting with provider/consumer
catheter care and only five residents associations and other groups as well
have catheters). as participating in seminars. It also in-
cludes informational activities, where-
Include in the sample those residents
by you respond to oral or written in-
who, in your judgment, are appropriate
quiries about required outcomes in
for reviewing vis-a-vis the cited sub-
care and services.
standard care. If possible, include some (n) Confidentiality and Respect for
residents identified as receiving sub- Resident Privacy. Conduct the survey in
standard care during the initial survey. a manner that allows for the greatest
If after completing the follow-up ac- degree of confidentiality for residents,
tivities you determine that the cited particularly regarding the information
deficiencies were not corrected, ini- gathered during the in-depth inter-
tiate adverse action procedures, as ap- views. When recording observations
propriate. about care and resident conditions,
(m) Role of Surveyor. The survey and protect the privacy of all residents. Use
certification process is intended to de- a code such as resident identifier num-
termine whether providers and sup- ber rather than names on worksheets
pliers meet program participation re- whenever possible. Never use a resi-
quirements. The primary role of the dent’s name on the Deficiency State-
surveyor, then, is to assess the quality ment, Form CMS–2567. Block out resi-
of care and services and to relate those dent names, if any, from any document
findings to statutory and regulatory that is disclosed to the facility, indi-
requirements for program participa- vidual or organization.
tion. When communicating to the facility
When you find substandard care or about substandard care, fully identify
services in the course of a survey, care- the resident(s) by name if the situation
fully document your findings. Explain was identified through observation or
the deficiency in sufficient detail so record review. Improperly applied re-
that the facility officials understand straints, expired medication, cold food,
your rationale. If the cause of the defi- gloves not worn for a sterile procedure,
ciency is obvious, share the informa- and diet inconsistent with order, are
tion with the provider. For example, if examples of problems which can be
you cite a deficiency for restraints identified to the facility by resident
(F118), indicate that restraints were ap- name. Information about injuries due
plied backwards on residents 1621, 1634, to broken equipment, prolonged use of
1646, etc. restraints, and opened mail is less like-
ly to be obtained through observation
In those instances where the cause is
or record review. Do not reveal the
not obvious, do not delve into the fa-
source of information unless actually
cility’s policies and procedures to de-
observed, discovered in the record re-
termine the root cause of any defi-
view, or requested by the resident or
ciency. Do not recommend or prescribe
family.
an acceptable remedy. The provider is
(o) Team Composition. Whenever pos-
responsible for deciding on and imple-
sible, use the following survey team
menting the action(s) necessary for
model:
achieving compliance. For the re-
straint situation in the example above, SNF/ICF SURVEY TEAM MODEL
you would not ascertain whether the
improper application was due to im- In facilities with 200 beds or less, the
proper training or lack of training, nor team size may range from 2 to 4 mem-
would you attempt to identify the staff bers. If the team size is:
member who applied the restraints. It • 2 members: The team has at least
is the provider’s responsibility to make one RN plus another RN or a dietitian
the necessary changes or corrections to or a pharmacist.
393
§ 488.110 42 CFR Ch. IV (10–1–17 Edition)
• 3–4 member: In addition to the com- • When a terminated facility re-

position described above, the team has quests program participation 60 days or
one or two members of any discipline more after termination. Treat this sit-
such as a social worker, sanitarian, uation as a request for initial certifi-
etc. cation and complete Part A of the sur-
If the facility has over 200 beds and vey report in addition to Part B.
the survey will last more than 2 days, • If an ICF with a favorable compli-
the team size may be greater than 4 ance history requests to covert a num-
members. Select additional disciplines ber of beds to SNF level, complete both
as appropriate to the facility’s compli- Part A and Part B for compliance with
ance history. the SNF requirements. If distinct part
Average onsite time per survey: 60 status is at issue, also examine wheth-
person hours (Number of surveyors er it meets the criteria for certifi-
cation as a distinct part.
multiplied by the number of hours on
site) (i) Addendum for Outpatient Physical
Preferably, team members have ge- Therapy (OPT) or Speech Pathology Serv-
rontological training and experience. ices. Use the Outpatient Physical Ther-
Any member may serve as the team apy—Speech Pathology SRF (CMS–
leader, consistent with State agency 1893) as an addendum to Part A.
procedures. In followup surveys, select (ii) Resurvey of Participating Facilities.
disciplines based on major areas of cor- Do not use Part A for resurveys of par-
rection. Include a social worker, for ex- ticipating SNFs and ICFs. A deter-
ample, if the survey revealed major mination of compliance, based on docu-
psychosocial problems. This model mented examination of the written
does not consider integrated survey policies and procedures and other perti-
and Inspection of Care review teams, nent documents during the initial sur-
which typically would be larger. vey, establishes the facility’s compli-
(p) Type of Facility—Application of ance status with Part A requirements.
SNF or ICF Regulations. Apply the regu- This does not preclude citing defi-
lations to the various types of facilities ciencies if they pertain to administra-
in the following manner: tive or structural requirements from
• Freestanding Skilled Nurs- Apply SNF regulations.
Part A that are uncovered incidental
ing Facility (SNF) to a Part B survey. As an assurance
• Freestanding Intermediate Apply ICF regulations. measure, however, each facility at the
Care Facility (ICF) time of recertification must complete
• SNF Distinct Part of a Hos- Apply SNF regulations.
pital an affidavit (on the CMS–1516) attest-
• ICF Distinct Part of a Hos- Apply ICF regulations. ing that no substantive changes have
pital occurred that would affect compliance.
• Dually Certified SNF/ICF Apply SNF regulations and Each facility must also agree to notify
442.346(b).
• Freestanding SNF with ICF Apply SNF regulations for the State agency immediately of any
Distinct Part (Regardless of SNF unit. upcoming changes in its organization
the proportion of SNF and Apply ICF regulations for ICF or management which may affect its
ICF beds, the facility type distinct part.
is determined by the higher Apply both SNF and ICF reg-
compliance status. If a new adminis-
level of care. Therefore, ulations for shared services trator is unable to complete the affi-
LTC facilities with distinct (e.g., dietary). davit, proceed with the survey using
parts are defined as SNFs If the same deficiency occurs the Part B form and worksheets; do not
with ICF distinct parts.) in both the SNF and ICF
components of the facility, use the Part A form. The survey cannot
cite both SNF and ICF reg- be considered complete, however, until
ulations. the affidavit is signed. If the facility
If the deficiency occurs in the
SNF part only, cite only the
fails to complete the affidavit, it can-
SNF regulation. not participate in the program.
If the deficiency occurs in the (iii) Substantial Changes in a Facility’s
ICF part only, cite only the Organization and Management. If you
ICF regulation.
receive such information, review the
(q) Use of Part A and Part B of the Sur- changes to ensure compliance with the
vey Report—(1) Use of Part A (CMS–525). regulations. Request copies of the ap-
Use Part A for initial certification sur- propriate documents (e.g., written poli-
veys only, except under the following cies and procedures, personnel quali-
circumstances: fications, or agreements) if they were
394
not submitted. If the changes have • CMS–523—Dining Area and Eating

made continued compliance seem Assistance Worksheet
doubtful, determine through a Part B • CMS–5245—Observation/Interview/
survey whether deficiencies have re- Record Review Worksheet
sulted. Cite any deficiencies on the For complaint investigations, per-
CMS–2567 and follow the usual proce- form a full or partial Part B survey
dures. based on the extent of the allegations.
(2) Use of Part B (CMS–519). Use Part If the complaint alleges substandard
B and the worksheets for all types of care in a general fashion or in a variety
SNF and ICF surveys—initials, recer- of services and care areas, perform sev-
tifications, followup, complaints, etc. eral tasks or a full Part B survey, as
The worksheets are: needed. If the complaint is of a more
specific nature, such as an allegation of
• CMS–520—Residents Selected for In- improper medications, perform an ap-
depth Review propriate partial Part B survey, such
• CMS–521—Tour Notes Worksheet as a drug pass review and a review of
• CMS–522—Drug Pass Worksheet selected medical records.
395
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
§ 488.115 Care guidelines.

396
EC01JA91.110</GPH>
397
EC01JA91.111</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
398
EC01JA91.112</GPH>
399
EC01JA91.113</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
400
EC01JA91.114</GPH>
401
EC01JA91.115</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
402
EC01JA91.116</GPH>
403
EC01JA91.117</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
404
EC01JA91.118</GPH>
405
EC01JA91.119</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
406
EC01JA91.120</GPH>
407
EC01JA91.121</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
408
EC01JA91.122</GPH>
409
EC01JA91.123</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
410
EC01JA91.124</GPH>
411
EC01JA91.125</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
412
EC01JA91.126</GPH>
413
EC01JA91.127</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
414
EC01JA91.128</GPH>
415
EC01JA91.129</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
416
EC01JA91.130</GPH>
417
EC01JA91.131</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
418
EC01JA91.132</GPH>
419
EC01JA91.133</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
420
EC01JA91.134</GPH>
421
EC01JA91.135</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
422
EC01JA91.136</GPH>
423
EC01JA91.137</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
424
EC01JA91.138</GPH>
425
EC01JA91.139</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
426
EC01JA91.140</GPH>
427
EC01JA91.141</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
428
EC01JA91.142</GPH>
429
EC01JA91.143</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
430
EC01JA91.144</GPH>
431
EC01JA91.145</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
432
EC01JA91.146</GPH>
433
EC01JA91.147</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
434
EC01JA91.148</GPH>
435
EC01JA91.149</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
436
EC01JA91.150</GPH>
437
EC01JA91.151</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
438
EC01JA91.152</GPH>
439
EC01JA91.153</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
440
EC01JA91.154</GPH>
441
EC01JA91.155</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
442
EC01JA91.156</GPH>
443
EC01JA91.157</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
444
EC01JA91.158</GPH>
445
EC01JA91.159</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
446
EC01JA91.160</GPH>
447
EC01JA91.161</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
448
EC01JA91.162</GPH>
449
EC01JA91.163</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
450
EC01JA91.164</GPH>
451
EC01JA91.165</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
452
EC01JA91.166</GPH>
453
EC01JA91.167</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
454
EC01JA91.168</GPH>
455
EC01JA91.169</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
456
EC01JA91.170</GPH>
457
EC01JA91.171</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
458
EC01JA91.172</GPH>
459
EC01JA91.173</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
460
EC01JA91.174</GPH>
461
EC01JA91.175</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
462
EC01JA91.176</GPH>
463
EC01JA91.177</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
464
EC01JA91.178</GPH>
465
EC01JA91.179</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
466
EC01JA91.180</GPH>
467
EC01JA91.181</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
468
EC01JA91.182</GPH>
469
EC01JA91.183</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
470
EC01JA91.184</GPH>
471
EC01JA91.185</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
472
EC01JA91.186</GPH>
473
EC01JA91.187</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
474
EC01JA91.188</GPH>
475
EC01JA91.189</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
476
EC01JA91.190</GPH>
477
EC01JA91.191</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
478
EC01JA91.192</GPH>
479
EC01JA91.193</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
480
EC01JA91.194</GPH>
481
EC01JA91.195</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
482
EC01JA91.196</GPH>
483
EC01JA91.197</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
484
EC01JA91.198</GPH>
485
EC01JA91.199</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
486
EC01JA91.200</GPH>
487
EC01JA91.201</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
488
EC01JA91.202</GPH>
489
EC01JA91.203</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
490
EC01JA91.204</GPH>
491
EC01JA91.205</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
492
EC01JA91.206</GPH>
493
EC01JA91.207</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
494
EC01JA91.208</GPH>
495
EC01JA91.209</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
496
EC01JA91.210</GPH>
497
EC01JA91.211</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
498
EC01JA91.212</GPH>
499
EC01JA91.213</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
500
EC01JA91.214</GPH>
501
EC01JA91.215</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
502
EC01JA91.246</GPH>
503
EC01JA91.216</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
504
EC01JA91.217</GPH>
505
EC01JA91.218</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
506
EC01JA91.219</GPH>
507
EC01JA91.220</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
508
EC01JA91.221</GPH>
509
EC01JA91.222</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
510
EC01JA91.223</GPH>
511
EC01JA91.224</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
512
EC01JA91.225</GPH>
513
EC01JA91.226</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
514
EC01JA91.227</GPH>
515
EC01JA91.228</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
516
EC01JA91.229</GPH>
517
EC01JA91.230</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
518
EC01JA91.231</GPH>
519
EC01JA91.232</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
520
EC01JA91.233</GPH>
521
EC01JA91.234</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
522
EC01JA91.235</GPH>
523
EC01JA91.236</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
524
EC01JA91.237</GPH>
525
EC01JA91.238</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
526
EC01JA91.239</GPH>
527
EC01JA91.240</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
528
EC01JA91.241</GPH>
529
EC01JA91.242</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
530
EC01JA91.243</GPH>
531
EC01JA91.244</GPH>
§ 488.115 42 CFR Ch. IV (10–1–17 Edition)
532
EC01JA91.245</GPH>
Subpart D—Reconsideration of quirements, may request a reconsider-

Adverse Determinations— ation of the determination by filing a
request with CMS either directly by its
Deeming Authority for Ac- authorized officials or through its legal
creditation Organizations and representative. The request must be
CLIA Exemption of Labora- filed within 60 days of the receipt of no-
tories Under State Programs tice of an adverse determination or
nonrenewal as provided in subpart A of
SOURCE: 57 FR 34012, July 31, 1992, unless part 488 or subpart E of part 493, as ap-
otherwise noted. plicable.
(2) Reconsideration procedures are
§ 488.201 Reconsideration. available after the effective date of the
(a) Right to reconsideration. (1) A na- decision to deny, remove, or not renew
tional accreditation organization dis- the approval of an accreditation orga-
satisfied with a determination that its nization or State laboratory program.
accreditation requirements do not pro- (d) Content of request. The request for
vide (or do not continue to provide) reconsideration must specify the find-
reasonable assurance that the entities ings or issues with which the accredita-
accredited by the accreditation organi- tion organization or State disagrees
zation meet the applicable long-term and the reasons for the disagreement.
care requirements, conditions for cov-
[57 FR 34012, July 31, 1992, as amended at 58
erage, conditions of certification, con-
FR 61843, Nov. 23, 1993]
ditions of participation, or CLIA condi-
tion level requirements is entitled to a § 488.203 Withdrawal of request for re-
reconsideration as provided in this sub- consideration.
part.
A requestor may withdraw its re-
(2) A State dissatisfied with a deter-
quest for reconsideration at any time
mination that the requirements it im-
before the issuance of a reconsideration
poses on laboratories in that State and
determination.
under the laws of that State do not
provide (or do not continue to provide) § 488.205 Right to informal hearing.
reasonable assurance that laboratories
licensed or approved by the State meet In response to a request for reconsid-
applicable CLIA requirements is enti- eration, CMS will provide the accredi-
tled to a reconsideration as provided in tation organization or the State lab-
this subpart. oratory program the opportunity for
(b) Eligibility for reconsideration. CMS an informal hearing as described in
will reconsider any determination to § 488.207 that will—
deny, remove or not renew the ap- (a) Be conducted by a hearing officer
proval of deeming authority to private appointed by the Administrator of
accreditation organizations, or any de- CMS; and
termination to deny, remove or not (b) Provide the accreditation organi-
renew the approval of a State labora- zation or State laboratory program the
tory program for the purpose of ex- opportunity to present, in writing or in
empting the State’s laboratories from person, evidence or documentation to
CLIA requirements, if the accredita- refute the determination to deny ap-
tion organization or State files a writ- proval, or to withdraw or not renew
ten request for a reconsideration in ac- deeming authority or the exemption of
cordance with paragraphs (c) and (d) of a State’s laboratories from CLIA re-
this section. quirements.
(c) Manner and timing of request for re-
consideration. (1) A national accredita- § 488.207 Informal hearing procedures.
tion organization or a State laboratory (a) CMS will provide written notice
program described in paragraph (b), of the time and place of the informal
dissatisfied with a determination with hearing at least 10 days before the
respect to its deeming authority, or, in scheduled date.
the case of a State, a determination (b) The informal reconsideration

with respect to the exemption of the hearing will be conducted in accord-
laboratories in the State from CLIA re- ance with the following procedures—
533
§ 488.209 42 CFR Ch. IV (10–1–17 Edition)
(1) The hearing is open to CMS and (d) The reconsideration determina-
the organization requesting the recon- tion of the Administrator is final.
sideration, including— (e) A final reconsideration deter-
(i) Authorized representatives; mination against an accreditation or-
(ii) Technical advisors (individuals ganization or State laboratory pro-
with knowledge of the facts of the case gram will be published by CMS in the
or presenting interpretation of the FEDERAL REGISTER.
facts); and
(iii) Legal counsel; Subpart E—Survey and Certifi-
(2) The hearing is conducted by the cation of Long-Term Care Fa-
hearing officer who receives testimony cilities
and documents related to the proposed
action;
(3) Testimony and other evidence otherwise noted.
may be accepted by the hearing officer
even though it would be inadmissable § 488.300 Statutory basis.
under the usual rules of court proce-
Sections 1819 and 1919 of the Act es-
dures;
tablish requirements for surveying
(4) Either party may call witnesses
SNFs and NFs to determine whether
from among those individuals specified
they meet the requirements for partici-
in paragraph (b)(1) of this section; and
pation in the Medicare and Medicaid
(5) The hearing officer does not have programs.
the authority to compel by subpoena
the production of witnesses, papers, or § 488.301 Definitions.
other evidence.
As used in this subpart—
§ 488.209 Hearing officer’s findings. Abbreviated standard survey means a
survey other than a standard survey
(a) Within 30 days of the close of the that gathers information primarily
hearing, the hearing officer will through resident-centered techniques
present the findings and recommenda- on facility compliance with the re-
tions to the accreditation organization quirements for participation. An abbre-
or State laboratory program that re- viated standard survey may be pre-
quested the reconsideration. mised on complaints received; a change
(b) The written report of the hearing of ownership, management, or director
officer will include— of nursing; or other indicators of spe-
(1) Separate numbered findings of cific concern. Abbreviated standard
fact; and surveys conducted to investigate a
(2) The legal conclusions of the hear- complaint or to conduct on-site moni-
ing officer. toring to verify compliance with par-
ticipation requirements are subject to
§ 488.211 Final reconsideration deter- the requirements of § 488.332. Other
mination.
premises for abbreviated standard sur-
(a) The hearing officer’s decision is veys would follow the requirements of
final unless the Administrator, within § 488.314.
30 days of the hearing officer’s deci- Abuse is the willful infliction of in-
sion, chooses to review that decision. jury, unreasonable confinement, in-
(b) The Administrator may accept, timidation, or punishment with result-
reject or modify the hearing officer’s ing physical harm, pain or mental an-
findings. guish. Abuse also includes the depriva-
(c) Should the Administrator choose tion by an individual, including a care-
to review the hearing officer’s decision, taker, of goods or services that are nec-
the Administrator will issue a final re- essary to attain or maintain physical,
consideration determination to the ac- mental, and psychosocial well-being.
creditation organization or State lab- Instances of abuse of all residents, irre-
oratory program on the basis of the spective of any mental or physical con-
hearing officer’s findings and rec- dition, cause physical harm, pain or
ommendations and other relevant in- mental anguish. It includes verbal
formation. abuse, sexual abuse, physical abuse,
534
and mental abuse including abuse fa- facility, or who is used under an ar-
cilitated or enabled through the use of rangement with another agency or or-
technology. Willful, as used in this defi- ganization.
nition of abuse, means the individual Partial extended survey means a sur-
must have acted deliberately, not that vey that evaluates additional partici-
the individual must have intended to pation requirements subsequent to
inflict injury or harm. finding substandard quality of care
Deficiency means a SNF’s or NF’s during an abbreviated standard survey.
failure to meet a participation require- Skilled nursing facility (SNF) means a
ment specified in the Act or in part 483, Medicare nursing facility.
subpart B of this chapter. Standard survey means a periodic,
Dually participating facility means a resident-centered inspection which
facility that has a provider agreement gathers information about the quality
in both the Medicare and Medicaid proof service furnished in a facility to de-
grams. termine compliance with the require-
Extended survey means a survey that ments for participation.
evaluates additional participation re-
Substandard quality of care means one
quirements subsequent to finding sub-
or more deficiencies related to partici-
standard quality of care during a
pation requirements under § 483.10
standard survey.
‘‘Resident rights’’, paragraphs (a)(1)
Facility means a SNF or NF, or a dis-
through (a)(2), (b)(1) through (b)(2), (e)
tinct part SNF or NF, in accordance
(except for (e)(2), (e)(7), and (e)(8)),
with § 483.5 of this chapter.
(f)(1) through (f)(3), (f)(5) through (f)(8),
Immediate family means husband or
and (i) of this chapter; § 483.12 of this
wife; natural or adoptive parent, child
chapter ‘‘Freedom from abuse, neglect,
or sibling; stepparent, stepchild, step-
and exploitation’’; § 483.24 of this chap-
brother, or stepsister; father-in-law,
ter ‘‘Quality of life’’; § 483.25 of this
mother-in-law, son-in-law, daughter-in-
chapter ‘‘Quality of care’’; § 483.40 ‘‘Be-
law, brother-in-law, or sister-in-law;
havioral health services’’, paragraphs
grandparent or grandchild.
(b) and (d) of this chapter; § 483.45
Immediate jeopardy means a situation
‘‘Pharmacy services’’, paragraphs (d),
in which the provider’s noncompliance
(e), and (f) of this chapter; § 483.70 ‘‘Ad-
with one or more requirements of par-
ministration’’, paragraph (p) of this
ticipation has caused, or is likely to
chapter, and § 483.80 ‘‘Infection con-
cause, serious injury, harm, impair-
trol’’, paragraph (d) of this chapter,
ment, or death to a resident.
which constitute either immediate
Misappropriation of resident property
jeopardy to resident health or safety; a
means the deliberate misplacement,
pattern of or widespread actual harm
exploitation, or wrongful, temporary or
that is not immediate jeopardy; or a
permanent use of a resident’s belong-
widespread potential for more than
ings or money without the resident’s
minimal harm, but less than imme-
consent.
diate jeopardy, with no actual harm.
Neglect is the failure of the facility,
its employees or service providers to Substantial compliance means a level
provide goods and services to a resident of compliance with the requirements of
that are necessary to avoid physical participation such that any identified
harm, pain, mental anguish, or emo- deficiencies pose no greater risk to
tional distress. resident health or safety than the po-
Noncompliance means any deficiency tential for causing minimal harm.
that causes a facility to not be in sub- Validation survey means a survey con-
stantial compliance. ducted by the Secretary within 2
Nurse aide means an individual, as de- months following a standard survey,
fined in § 483.5 of this chapter. abbreviated standard survey, partial
Nursing facility (NF) means a Med- extended survey, or extended survey
icaid nursing facility. for the purpose of monitoring State
Paid feeding assistant means an indi- survey agency performance.
vidual who meets the requirements [59 FR 56238, Nov. 10, 1994, as amended at 68
specified in § 483.60(h)(1) of this chapter FR 55539, Sept. 26, 2003; 81 FR 68871, Oct. 4,
and who is paid to feed residents by a 2016; 82 FR 36635, Aug. 4, 2017]
535
§ 488.303 42 CFR Ch. IV (10–1–17 Edition)
§ 488.303 State plan requirement. ance and correcting deficiencies as the

(a) A State plan must provide that remedies listed in paragraphs (d) and
the requirements of this subpart and (e) of this section.
subpart F of this part are met, to the [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
extent that those requirements apply 28, 1995]
to the Medicaid program.
(b) A State may establish a program § 488.305 Standard surveys.
to reward, through public recognition, (a) For each SNF and NF, the State
incentive payments, or both, nursing survey agency must conduct standard
facilities that provide the highest qual- surveys that include all of the fol-
ity care to Medicaid residents. For pur- lowing:
poses of section 1903(a)(7) of the Social (1) A case-mix stratified sample of
Security Act, proper expenses incurred residents;
by a State in carrying out such a pro- (2) A survey of the quality of care
gram are considered to be expenses furnished, as measured by indicators of
necessary for the proper and efficient medical, nursing, and rehabilitative
administration of the State plan. care, dietary and nutrition services, ac-
(c) A State must conduct periodic tivities and social participation, and
educational programs for the staff and sanitation, infection control, and the
residents (and their representatives) of physical environment;
NFs in order to present current regula- (3) An audit of written plans of care
tions, procedures, and policies under and residents’ assessments to deter-
this subpart and subpart F of this part. mine the accuracy of such assessments
(d) Required remedies for a non-State and the adequacy of such plans of care;
operated NF. A State must establish, and
in addition to termination of the pro- (4) A review of compliance with resi-
vider agreement, the following rem- dents’ rights requirements set forth in
edies or an approved alternative to the sections 1819(c) and 1919(c) of the Act.
following remedies for imposition (b) The State survey agency’s failure
against a non-State operated NF: to follow the procedures set forth in
(1) Temporary management. this section will not invalidate other-
(2) Denial of payment for new admis- wise legitimate determinations that a
sions. facility’s deficiencies exist.
(3) Civil money penalties.
(4) Transfer of residents. § 488.307 Unannounced surveys.
(5) Closure of the facility and trans- (a) Basic rule. All standard surveys
fer of residents. must be unannounced.
(6) State monitoring. (b) Review of survey agency’s sched-
(e) Optional remedies for a non-State uling and surveying procedures. (1) CMS
operated NF. A State may establish reviews on an annual basis each State
the following remedies for imposition survey agency’s scheduling and sur-
against a non-State operated NF: veying procedures and practices to en-
(1) Directed plan of correction. sure that survey agencies avoid giving
(2) Directed in-service training. notice of a survey through the sched-
(3) Alternative or additional State uling procedures and the conduct of the
remedies. surveys.
(f) Alternative or additional State (2) CMS takes corrective action in
remedies. If a State uses remedies that accordance with the nature and com-
are in addition to those specified in plexity of the problem when survey
paragraph (d) or (e) of this section, or agencies are found to have notified a
alternative to those specified in para- SNF or NF through their scheduling or
graph (d) of this section (other than procedural policies. Sanctions for inad-
termination of participation), it equate survey performance are in ac-
must— cordance with § 488.320.
(1) Specify those remedies in the (c) Civil money penalties. An indi-
State plan; and vidual who notifies a SNF or NF, or
(2) Demonstrate to CMS’s satisfac- causes a SNF or NF to be notified, of

tion that those alternative remedies the time or date on which a standard
are as effective in deterring noncompli- survey is scheduled to be conducted is
536
subject to a Federal civil money pen- quirements by SNFs and NFs if its re-
alty not to exceed $2,000 as adjusted an- view of the allegation concludes that—
nually under 45 CFR part 102. (i) A deficiency in one or more of the
requirements may have occurred; and
(ii) Only a survey can determine
FR 61563, Sept. 6, 2016]
whether a deficiency or deficiencies
§ 488.308 Survey frequency. exist.
(2) The survey agency does not con-
(a) Basic period. The survey agency duct a survey if the complaint raises
must conduct a standard survey of issues that are outside the purview of
each SNF and NF not later than 15 Federal participation requirements.
months after the last day of the pre-
vious standard survey. [53 FR 22859, June 17, 1988, as amended at 82
FR 36635, Aug. 4, 2017]
(b) Statewide average interval. (1) The
statewide average interval between § 488.310 Extended survey.
standard surveys must be 12 months or
less, computed in accordance with (a) Purpose of survey. The purpose of
paragraph (d) of this section. an extended survey is to identify the
(2) CMS takes corrective action in policies and procedures that caused the
accordance with the nature of the facility to furnish substandard quality
of care.
State survey agency’s failure to ensure
(b) Scope of extended survey. An ex-
that the 12-month statewide average
tended survey includes all of the fol-
interval requirement is met. CMS’s
lowing:
corrective action is in accordance with
(1) Review of a larger sample of resi-
§ 488.320.
dent assessments than the sample used
(c) Other surveys. The survey agency in a standard survey.
may conduct a survey as frequently as (2) Review of the staffing and in-serv-
necessary to— ice training.
(1) Determine whether a facility com- (3) If appropriate, examination of the
plies with the participation require- contracts with consultants.
ments; and (4) A review of the policies and proce-
(2) Confirm that the facility has cor- dures related to the requirements for
rected deficiencies previously cited. which deficiencies exist.
(d) Computation of statewide average (5) Investigation of any participation
interval. The statewide average interval requirement at the discretion of the
is computed at the end of each Federal survey agency.
fiscal year by comparing the last day (c) Timing and basis for survey. The
of the most recent standard survey for survey agency must conduct an ex-
each participating facility to the last tended survey not later than 14 cal-
day of each facility’s previous standard endar days after completion of a stand-
survey. ard survey which found that the facil-
(e) Special surveys. (1) The survey ity had furnished substandard quality
agency may conduct a standard or an of care.
abbreviated standard survey to deter-
mine whether certain changes have § 488.312 Consistency of survey re-
caused a decline in the quality of care sults.
furnished by a SNF or a NF, within 60 CMS does and the survey agency
days of a change in the following: must implement programs to measure
(i) Ownership; accuracy and improve consistency in
(ii) Entity responsible for manage- the application of survey results and
ment of a facility (management firm); enforcement remedies.
(iii) Nursing home administrator; or
(iv) Director of nursing. § 488.314 Survey teams.
(2) [RESERVED] (a) Team composition. (1) Surveys
(f) Investigation of complaints. (1) The under sections 1819(g)(2) and 1919(g)(2)
survey agency must review all com- of the Social Security Act must be con-
plaint allegations and conduct a stand- ducted by an interdisciplinary team of

ard or an abbreviated survey to inves- professionals, which must include a
tigate complaints of violations of re- registered nurse.
537
§ 488.318 42 CFR Ch. IV (10–1–17 Edition)
(2) Examples of professionals include, survey as a trainee if accompanied on-

but are not limited to, physicians, phy- site by a surveyor who has successfully
sician assistants, nurse practitioners, completed the required training and
physical, speech, or occupational testing program.
therapists, registered professional
[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
nurses, dieticians, sanitarians, engi-
28, 1995 as amended at 82 FR 36636, Aug. 4,
neers, licensed practical nurses, or so- 2017]
cial workers.
(3) The State determines what con- § 488.318 Inadequate survey perform-
stitutes a professional, subject to CMS ance.
approval.
(a) CMS considers survey perform-
(4) Any of the following cir-
cumstances disqualifies a surveyor for ance to be inadequate if the State sur-
surveying a particular facility: vey agency—
(i) The surveyor currently works, or, (1) Indicates a pattern of failure to—
within the past two years, has worked (i) Identify deficiencies and the fail-
as an employee, as employment agency ure cannot be explained by changed
staff at the facility, or as an officer, conditions in the facility or other case
consultant, or agent for the facility to specific factors;
be surveyed. (ii) Cite only valid deficiencies;
(ii) The surveyor has any financial (iii) Conduct surveys in accordance
interest or any ownership interest in with the requirements of this subpart;
the facility. or
(iii) The surveyor has an immediate (iv) Use Federal standards, protocols,
family member who has a relationship and the forms, methods and procedures
with a facility described in paragraphs specified by CMS in manual instruc-
(a)(4)(i) or paragraph (a)(4)(ii) of this tions; or
section. (2) Fails to identify an immediate
(iv) The surveyor has an immediate jeopardy situation.
family member who is a resident in the (b) Inadequate survey performance
facility to be surveyed. For purposes of does not—
this section, an immediate family (1) Relieve a SNF or NF of its obliga-
member is defined at § 488.301 of this tion to meet all requirements for pro-
part. gram participation; or
(b) CMS training. CMS provides com-
(2) Invalidate adequately documented
prehensive training to surveyors, in-
deficiencies.
cluding at least the following:
(1) Application and interpretation of § 488.320 Sanctions for inadequate sur-
regulations for SNFs and NFs. vey performance.
(2) Techniques and survey procedures
for conducting standard and extended (a) Annual assessment of survey per-
surveys. formance. CMS assesses the perform-
(3) Techniques for auditing resident ance of the State’s survey and certifi-
assessments and plans of care. cation program annually.
(c) Required surveyor training. (1) Ex- (b) Sanctions for inadequate survey per-
cept as specified in paragraph (c)(3) of formance. When a State demonstrates
this section, the survey agency may inadequate survey performance, as
not permit an individual to serve as a specified in § 488.318, CMS notifies the
member of a survey team unless the in- survey agency of the inadequacy and
dividual has successfully completed a takes action in accordance with para-
training and testing program pre- graphs (c) and (d) of this section.
scribed by the Secretary. (c) Medicaid facilities. (1) For a pat-
(2) The survey agency must have a tern of failure to identify deficiencies
mechanism to identify and respond to in Medicaid facilities, CMS—
in-service training needs of the sur- (i) Reduces FFP, as specified in para-
veyors. graph (e) of this section, and if appro-
(3) The survey agency may permit an priate;

individual who has not completed a (ii) Provides for training of survey
training program to participate in a teams.
538
(2) For other survey inadequacies in (5) Final appeal results.

Medicaid facilities, CMS provides for (6) Notice of termination of a facil-
training of survey teams. ity.
(d) Medicare facilities. For all survey (7) Medicare and Medicaid cost re-
inadequacies in Medicare facilities, ports.
CMS— (8) Names of individuals with direct
(1) Requires that the State survey or indirect ownership interest in a SNF
agency submit a plan of correction; or NF, as defined in § 420.201 of this
(2) Provides for training of survey chapter.
teams; (9) Names of individuals with direct
(3) Provides technical assistance on or indirect ownership interest in a SNF
scheduling and procedural policies; or NF, as defined in § 420.201 of this
(4) Provides CMS-directed sched- chapter, who have been found guilty by
uling; or a court of law of a criminal offense in
(5) Initiates action to terminate the violation of Medicare or Medicaid law.
agreement between the Secretary and (b) Charge to public for information.
the State under section 1864 of the Act, CMS and the State may charge the
either in whole or in part. public for specified services with re-
(e) Reduction of FFP. In reducing FFP spect to requests for information in ac-
for inadequate survey performance, cordance with—
CMS uses the formula specified in sec- (1) Section 401.140 of this chapter, for
tion 1919(g)(3)(C) of the Act, that is 33 Medicare; or
percent multiplied by a fraction— (2) State procedures, for Medicaid.
(1) The numerator of which is equal (c) How public can request information.
to the total number of residents in the The public may request information in
NFs that CMS found to be noncompli- accordance with disclosure procedures
ant during validation surveys for that specified in 45 CFR part 5.
quarter; and (d) When information must be disclosed.
(2) The denominator of which is equal The disclosing agency must make
to the total number of residents in the available to the public, upon the
NFs in which CMS conducted valida- public’s request, information con-
tion surveys during that quarter. cerning all surveys and certifications
(f) Appeal of FFP reduction. When a of SNFs and NFs, including statements
State is dissatisfied with CMS’s deter- of deficiencies, separate listings of any
mination to reduce FFP, the State isolated deficiencies that constitute no
may appeal the determination to the actual harm, with the potential for
Departmental Appeals Board, using the minimal harm, and plans of correction
procedures specified in 45 CFR part 16. (which contain any provider response
to the deficiency statement) within 14
§ 488.325 Disclosure of results of sur- calendar days after each item is made
veys and activities. available to the facility.
(a) Information which must be provided (e) Procedures for responding to re-
to public. As provided in sections quests. The procedures and time periods
1819(g)(5) and 1919(g)(5) of the Act, the for responding to requests are in ac-
following information must be made cordance with—
available to the public, upon the (1) Section 401.136 of this chapter for
public’s request, by the State or CMS documents maintained by CMS; and
for all surveys and certifications of (2) State procedures for documents
SNFs and NFs: maintained by the State.
(1) Statements of deficiencies and (f) Information that must be provided to
providers’ comments. the State’s long-term care ombudsman.
(2) A list of isolated deficiencies that The State must provide the State’s
constitute no actual harm, with the po- long-term care ombudsman with the
tential for minimal harm. following:
(3) Approved plans of correction. (1) A statement of deficiencies re-
(4) Statements that the facility did flecting facility noncompliance, includ-
not submit an acceptable plan of cor- ing a separate list of isolated defi-
rection or failed to comply with the ciencies that constitute no harm with
conditions of imposed remedies. the potential for minimal harm.
539
§ 488.330 42 CFR Ch. IV (10–1–17 Edition)
(2) Reports of adverse actions speci- (A) The State certifies the compli-
fied at § 488.406 imposed on a facility. ance or noncompliance of non-State
(3) Written response by the provider. operated NFs. Regardless of the State
(4) A provider’s request for an appeal entity doing the certification, it is
and the results of any appeal. final, except in the case of a complaint
(g) Information which must be provided or validation survey conducted by
to State by a facility with substandard CMS, or CMS review of the State’s
quality of care. (1) To provide for the findings.
notice to physicians required under (B) CMS certifies the compliance or
sections 1819(g)(5)(C) and 1919(g)(5)(C) of noncompliance of all State-operated fa-
the Act, not later than 10 working days cilities.
after receiving a notice of substandard (C) The State survey agency certifies
quality of care, a SNF or NF must pro- the compliance or noncompliance of a
vide the State with a list of— non-State operated SNF, subject to the
(i) Each resident in the facility with approval of CMS.
respect to which such finding was (D) The State survey agency certifies
made; and compliance or noncompliance for a du-
(ii) The name and address of his or ally participating SNF/NF. In the case
her attending physician. of a disagreement between CMS and
(2) Failure to disclose the informa- the State survey agency, a finding of
tion timely will result in termination noncompliance takes precedence over
of participation or imposition of alter- that of compliance.
native remedies. (ii) In the case of a validation survey,
(h) Information the State must provide the Secretary’s determination as to the
to attending physician and State board. facility’s noncompliance is binding,
Not later than 20 calendar days after a and takes precedence over a certifi-
SNF or NF complies with paragraph (g) cation of compliance resulting from
of this section, the State must provide the State survey.
written notice of the noncompliance (2) Basis for certification. (i) Certifi-
to— cation by the State is based on the sur-
(1) The attending physician of each vey agency findings.
resident in the facility with respect to (ii) Certification by CMS is based on
which a finding of substandard quality either the survey agency findings (in
of care was made; and the case of State-operated facilities),
(2) The State board responsible for li- or, in the case of a validation survey,
censing the facility’s administrator. on CMS’s own survey findings.
(i) Access to information by State Med- (b) Effect of certification—(1) Certifi-
icaid fraud control unit. The State must cation of compliance. A certification of
provide access to any survey and cer- compliance constitutes a determina-
tification information incidental to a tion that the facility is in substantial
SNF’s or NF’s participation in Medi- compliance and is eligible to partici-
care or Medicaid upon written request pate in Medicaid as a NF, or in Medi-
by the State Medicaid fraud control care as a SNF, or in Medicare and Med-
unit established under part 1007, of this icaid as a dually participating facility.
title, consistent with current State (2) Certification of noncompliance. A
laws. certification of noncompliance requires
[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. denial of participation for prospective
28, 1995] providers and enforcement action for
current providers in accordance with
§ 488.330 Certification of compliance subpart F of this part. Enforcement ac-
or noncompliance. tion must include one of the following:
(a) General rules—(1) Responsibility for (i) Termination of any Medicare or
certification. (i) The State survey agen- Medicaid provider agreements that are
cy surveys all facilities for compliance in effect.
or noncompliance with requirements (ii) Application of alternative rem-
for long term care facilities. The sur- edies instead of, or in addition to, ter-
vey by the State survey agency may be mination procedures.

followed by a Federal validation sur- (c) Notice of certification of noncompli-
vey. ance and resulting action. The notice of
540
certification of noncompliance is sent (ii) SNFs and dually participating

in accordance with the timeframes SNF/NFs; and
specified in § 488.402(f), and resulting (iii) Any other facilities subject to a
action is issued by CMS, except when CMS validation survey or CMS review
the State is taking the action for a of the State’s findings.
non-State operated NF. (4) The provisions of part 431 of this
(d) Content of notice of certification of chapter apply when a non-State oper-
noncompliance. The notice of certifi- ated Medicaid NF, which has not re-
cation of noncompliance is sent in ac- ceived a CMS validation survey or CMS
cordance with the timeframes specified review of the State’s findings, requests
in § 488.402(f) and includes information a hearing on the State’s denial of par-
on all of the following: ticipation, termination of provider
(1) Nature of noncompliance. agreement, or certification of non-
(2) Any alternative remedies to be compliance leading to an alternative
imposed under subpart F of this part. remedy, except State monitoring.
(3) Any termination or denial of par- (f) Provider agreements. CMS or the
ticipation action to be taken under Medicaid agency may execute a pro-
this part. vider agreement when a prospective
(4) The appeal rights available to the provider is in substantial compliance
facility under this part. with all the requirements for participa-
(5) Timeframes to be met by the pro- tion for a SNF or NF, respectively.
vider and certifying agency with regard (g) Special rules for Federal validation
to each of the enforcement actions or surveys. (1) CMS may make inde-
appeal procedures addressed in the no- pendent certifications of a NF’s, SNF’s,
tice. or dually participating facility’s non-
(e) Appeals. (1) Notwithstanding any compliance based on a CMS validation
provision of State law, the State must survey.
impose remedies promptly on any pro- (2) CMS issues the notice of actions
vider of services participating in the affecting facilities for which CMS did
Medicaid program— validation surveys.
(i) After promptly notifying the facil- (3) For non-State-operated NFs and
ity of the deficiencies and impending non-State-operated dually partici-
remedy or remedies; and pating facilities, any disagreement be-
(ii) Except for civil money penalties, tween CMS and the State regarding the
during any pending hearing that may timing and choice of remedies is re-
be requested by the provider of serv- solved in accordance with § 488.452.
ices. (4) Either CMS or the survey agency,
(2) CMS imposes remedies promptly at CMS’s option, may revisit the facil-
on any provider of services partici- ity to ensure that corrections are
pating in the Medicare or Medicaid made.
program or any provider of services [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
participating in both the Medicare and 28, 1995; 76 FR 15126, Mar. 18, 2011]
Medicaid programs—
(i) After promptly notifying the facil- § 488.331 Informal dispute resolution.
ity of the deficiencies and impending (a) Opportunity to refute survey find-
remedy or remedies; and ings. (1) For non-Federal surveys, the
(ii) Except for civil money penalties State must offer a facility an informal
imposed on NFs-only by the State, dur- opportunity, at the facility’s request,
ing any pending hearing that may be to dispute survey findings upon the fa-
requested by the provider of services. cility’s receipt of the official state-
(3) The provisions of part 498 of this ment of deficiencies.
chapter apply when the following pro- (2) For Federal surveys, CMS offers a
viders request a hearing on a denial of facility an informal opportunity, at the
participation, or certification of non- facility’s request, to dispute survey
compliance leading to an enforcement findings upon the facility’s receipt of
remedy (including termination of the the official statement of deficiencies.
provider agreement), except State (3) For SNFs, dually-participating

monitoring: SNF/NFs, and NF-only facilities that
(i) All State-operated facilities; have civil money penalties imposed by
541
§ 488.332 42 CFR Ch. IV (10–1–17 Edition)
CMS that will be placed in a CMS es- have a means of communicating infor-
crow account, CMS also offers the fa- mation among appropriate entities,
cility an opportunity for independent and the State survey agency retains re-
informal dispute resolution, subject to sponsibility for the investigation proc-
the terms of paragraphs (b), (c), and (d) ess.
of this section and of § 488.431. The fa- (4) If, after investigating a com-
cility must request independent infor- plaint, the State has reason to believe
mal dispute resolution in writing with- that an identifiable individual ne-
in 10 days of receipt of CMS’s offer. glected or abused a resident, or mis-
However, a facility may not use the appropriated a resident’s property, the
dispute resolution processes at both State survey agency must act on the
§§ 488.331 and 488.431 for the same defi- complaint in accordance with § 488.335.
ciency citation arising from the same (b) On-site monitoring. The State sur-
survey unless the informal dispute res- vey agency conducts on-site moni-
olution process at § 488.331 was com- toring on an as necessary basis when—
pleted prior to the imposition of the (1) A facility is not in substantial
civil money penalty. compliance with the requirements and
(b)(1) Failure of the State or CMS, as is in the process of correcting defi-
appropriate, to complete informal dis- ciencies;
pute resolution timely cannot delay (2) A facility has corrected defi-
the effective date of any enforcement ciencies and verification of continued
action against the facility. substantial compliance is needed; or
(2) A facility may not seek a delay of (3) The survey agency has reason to
any enforcement action against it on question the substantial compliance of
the grounds that informal dispute reso- the facility with a requirement of par-
lution has not been completed before ticipation.
the effective date of the enforcement (c) Composition of the investigative
action. team. A State may use a specialized
(c) If a provider is subsequently suc- team, which may include an attorney,
cessful, during the informal dispute auditor and appropriate health profes-
resolution process, at demonstrating sionals, to identify, survey, gather and
that deficiencies should not have been preserve evidence, and administer rem-
cited, the deficiencies are removed edies to noncompliant facilities.
from the statement of deficiencies and
any enforcement actions imposed sole- § 488.334 Educational programs.
ly as a result of those cited deficiencies A State must conduct periodic edu-
are rescinded. cational programs for the staff and
(d) Notification. Upon request, CMS residents (and their representatives) of
does and the State must provide the fa- SNFs and NFs in order to present cur-
cility with written notification of the rent regulations, procedures, and poli-
informal dispute resolution process. cies on the survey, certification and
[59 FR 56238, Nov. 10, 1994, as amended at 76 enforcement process under this subpart
FR 15126, Mar. 18, 2011] and subpart F of this part.
§ 488.332 Investigation of complaints § 488.335 Action on complaints of resi-

of violations and monitoring of dent neglect and abuse, and mis-
compliance. appropriation of resident property.
(a) Investigation of complaints. (1) The (a) Investigation. (1) The State must
State survey agency must establish review all allegations of resident ne-
procedures and maintain adequate staff glect and abuse, and misappropriation
to investigate complaints of violations of resident property and follow proce-
of participation requirements. dures specified in § 488.332.
(2) The State survey agency takes ap- (2) If there is reason to believe, either
propriate precautions to protect a com- through oral or written evidence that
plainant’s anonymity and privacy, if an individual used by a facility to pro-
possible. vide services to residents could have
(3) If arrangements have been made abused or neglected a resident or mis-

with other State components for inves- appropriated a resident’s property, the
tigation of complaints, the State must State must investigate the allegation.
542
(3) The State must have written pro- (e) Factors beyond the individual’s con-
cedures for the timely review and in- trol. A State must not make a finding
vestigation of allegations of resident that an individual has neglected a resi-
abuse and neglect, and misappropria- dent if the individual demonstrates
tion of resident property. that such neglect was caused by factors
(b) Source of complaints. The State beyond the control of the individual.
must review all allegations regardless (f) Report of findings. If the finding is
of the source. that the individual has neglected or
(c) Notification—(1) Individuals to be abused a resident or misappropriated
notified. If the State makes a prelimi- resident property or if the individual
nary determination, based on oral or waives the right to a hearing, the State
written evidence and its investigation, must report the findings in writing
that the abuse, neglect or misappro- within 10 working days to—
priation of property occurred, it must (1) The individual;
notify in writing— (2) The current administrator of the
(i) The individuals implicated in the facility in which the incident occurred;
investigation; and and
(ii) The current administrator of the (3) The administrator of the facility
facility in which the incident occurred. that currently employs the individual,
(2) Timing of the notice. The State if different than the facility in which
must notify the individuals specified in the incident occurred;
paragraph (c)(1) of this section in writ-
(4) The licensing authority for indi-
ing within 10 working days of the
viduals used by the facility other than
State’s investigation.
nurse aides, if applicable; and
(3) Contents of the notice. The notice
(5) The nurse aide registry for nurse
must include the—
aides. Only the State survey agency
(i) Nature of the allegation(s);
may report the findings to the nurse
(ii) Date and time of the occurrence; aide registry, and this must be done
(iii) Right to a hearing; within 10 working days of the findings,
(iv) Intent to report the substan- in accordance with § 483.156(c) of this
tiated findings in writing, once the in- chapter. The State survey agency may
dividual has had the opportunity for a not delegate this responsibility.
hearing, to the nurse aide registry or (g) Contents and retention of report of
appropriate licensure authority; finding to the nurse aide registry. (1) The
(v) Fact that the individual’s failure report of finding must include informa-
to request a hearing in writing within tion in accordance with § 483.156(c) of
30 days from the date of the notice will this chapter.
result in reporting the substantiated
(2) The survey agency must retain
findings to the nurse aide registry or
the information as specified in para-
appropriate licensure authority.
graph (g)(1) of this section, in accord-
(vi) Consequences of waiving the
ance with the procedures specified in
right to a hearing;
§ 483.156(c) of this chapter.
(vii) Consequences of a finding
(h) Survey agency responsibility. (1)
through the hearing process that the
The survey agency must promptly re-
alleged resident abuse or neglect, or
view the results of all complaint inves-
misappropriation of resident property
did occur; and tigations and determine whether or not
a facility has violated any require-
(viii) Fact that the individual has the
ments in part 483, subpart B of this
right to be represented by an attorney
chapter.
at the individual’s own expense.
(d) Conduct of hearing. (1) The State (2) If a facility is not in substantial
must complete the hearing and the compliance with the requirements in
hearing record within 120 days from the part 483, subpart B of this chapter, the
day it receives the request for a hear- survey agency initiates appropriate ac-
ing. tions, as specified in subpart F of this
(2) The State must hold the hearing part.

at a reasonable place and time conven- [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
ient for the individual. 28, 1995]
543
§ 488.400 42 CFR Ch. IV (10–1–17 Edition)
Subpart F—Enforcement of Com- (c) Number of remedies. CMS or the

pliance for Long-Term Care State may apply one or more remedies
for each deficiency constituting non-
Facilities with Deficiencies compliance or for all deficiencies con-
stituting noncompliance.
SOURCE: 59 FR 56243, Nov. 10, 1994, unless (d) Plan of correction requirement. (1)
otherwise noted.
Except as specified in paragraph (d)(2)
§ 488.400 Statutory basis. of this section, regardless of which
remedy is applied, each facility that
Sections 1819(h) and 1919(h) of the Act has deficiencies with respect to pro-
specify remedies that may be used by gram requirements must submit a plan
the Secretary or the State respectively of correction for approval by CMS or
when a SNF or a NF is not in substan- the survey agency.
tial compliance with the requirements (2) Isolated deficiencies. A facility is
for participation in the Medicare and not required to submit a plan of correc-
Medicaid programs. These sections also tion when it has deficiencies that are
provide for ensuring prompt compli- isolated and have a potential for mini-
ance and specify that these remedies mal harm, but no actual harm has oc-
are in addition to any other available curred.
under State or Federal law, and, ex- (e) Disagreement regarding remedies. If
cept, for civil money penalties imposed the State and CMS disagree on the de-
on NFs-only by the State, are imposed cision to impose a remedy, the dis-
prior to the conduct of a hearing. agreement is resolved in accordance
[76 FR 15126, Mar. 18, 2011] with § 488.452.
(f) Notification requirements—(1) Ex-
§ 488.401 Definitions. cept when the State is taking action
As used in this subpart— against a non-State operated NF, CMS
or the State (as authorized by CMS)
New admission means a resident who
gives the provider notice of the rem-
is admitted to the facility on or after
edy, including the—
the effective date of a denial of pay-
(i) Nature of the noncompliance;
ment remedy and, if previously admit-
(ii) Which remedy is imposed;
ted, has been discharged before that ef-
(iii) Effective date of the remedy; and
fective date. Residents admitted before
(iv) Right to appeal the determina-
the effective date of the denial of pay-
tion leading to the remedy.
ment, and taking temporary leave, are
(2) When a State is taking action
not considered new admissions, nor
against a non-State operated NF, the
subject to the denial of payment.
State’s notice must include the same
Plan of correction means a plan devel-
information required by CMS in para-
oped by the facility and approved by
graph (f)(1) of this section.
CMS or the survey agency that de-
(3) Immediate jeopardy—2 day notice.
scribes the actions the facility will
Except for civil money penalties and
take to correct deficiencies and speci-
State monitoring imposed when there
fies the date by which those defi-
is immediate jeopardy, for all remedies
ciencies will be corrected.
specified in § 488.406 imposed when
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. there is immediate jeopardy, the notice
28, 1995] must be given at least 2 calendar days
before the effective date of the enforce-
§ 488.402 General provisions. ment action.
(a) Purpose of remedies. The purpose of (4) No immediate jeopardy—15 day no-
remedies is to ensure prompt compli- tice. Except for civil money penalties
ance with program requirements. and State monitoring, notice must be
(b) Basis for imposition and duration of given at least 15 calendar days before
remedies. When CMS or the State choos- the effective date of the enforcement
es to apply one or more remedies speci- action in situations in which there is
fied in § 488.406, the remedies are ap- no immediate jeopardy.
plied on the basis of noncompliance (5) Date of enforcement action. The 2-

found during surveys conducted by and 15-day notice periods begin when
CMS or by the survey agency. the facility receives the notice.
544
(6) Civil money penalties. For civil (A) Skilled nursing facility, for Medi-
money penalties, the notices must be care;
given in accordance with the provisions (B) State, for Medicaid; or
of §§ 488.434 and 488.440. (ii) Denial of payment for all new ad-
(7) State monitoring. For State moni- missions.
toring, no prior notice is required. (3) Civil money penalties.
(4) State monitoring.
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept.
28, 1995, as amended at 64 FR 13360, Mar. 18,
(5) Transfer of residents.
1999] (6) Closure of the facility and trans-
fer of residents.
§ 488.404 Factors to be considered in (7) Directed plan of correction.
selecting remedies. (8) Directed in-service training.
(a) Initial assessment. In order to se- (9) Alternative or additional State
lect the appropriate remedy, if any, to remedies approved by CMS.
apply to a facility with deficiencies, (b) Remedies that must be established.
CMS and the State determine the seri- At a minimum, and in addition to ter-
ousness of the deficiencies. mination of the provider agreement,
(b) Determining seriousness of defi- the State must establish the following
ciencies. To determine the seriousness remedies or approved alternatives to
of the deficiency, CMS considers and the following remedies:
the State must consider at least the (1) Temporary management.
following factors: (2) Denial of payment for new admis-
(1) Whether a facility’s deficiencies sions.
constitute— (3) Civil money penalties.
(i) No actual harm with a potential (4) Transfer of residents.
for minimal harm; (5) Closure of the facility and trans-
(ii) No actual harm with a potential fer of residents.
for more than minimal harm, but not (6) State monitoring.
immediate jeopardy; (c) State plan requirement. If a State
(iii) Actual harm that is not imme- wishes to use remedies for noncompli-
diate jeopardy; or ance that are either additional or al-
(iv) Immediate jeopardy to resident ternative to those specified in para-
health or safety. graphs (a) or (b) of this section, it
(2) Whether the deficiencies— must—
(i) Are isolated; (1) Specify those remedies in the
(ii) Constitute a pattern; or State plan; and
(iii) Are widespread. (2) Demonstrate to CMS’s satisfac-
(c) Other factors which may be consid- tion that those remedies are as effec-
ered in choosing a remedy within a rem- tive as the remedies listed in paragraph
edy category. Following the initial as- (a) of this section, for deterring non-
sessment, CMS and the State may con- compliance and correcting deficiencies.
sider other factors, which may include, (d) State remedies in dually partici-
but are not limited to the following: pating facilities. If the State’s remedy is
(1) The relationship of the one defi- unique to the State plan and has been
ciency to other deficiencies resulting approved by CMS, then that remedy, as
in noncompliance. imposed by the State under its Med-
(2) The facility’s prior history of non- icaid authority, may be imposed by
compliance in general and specifically CMS against the Medicare provider
with reference to the cited deficiencies. agreement of a dually participating fa-
cility.
§ 488.406 Available remedies. [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept.
(a) General. In addition to the remedy 28, 1995]
of termination of the provider agree-
ment, the following remedies are avail- § 488.408 Selection of remedies.
able: (a) Categories of remedies. In this sec-
(1) Temporary management. tion, the remedies specified in
(2) Denial of payment including— § 488.406(a) are grouped into categories

(i) Denial of payment for all individ- and applied to deficiencies according to
uals, imposed by CMS, to a— how serious the noncompliance is.
545
§ 488.408 42 CFR Ch. IV (10–1–17 Edition)
(b) Application of remedies. After con- (3) CMS or the State may apply one
sidering the factors specified in or more of the remedies in Category 2
§ 488.404, as applicable, if CMS and the to any deficiency except when—
State choose to impose remedies, as (i) The facility is in substantial com-
provided in paragraphs (c)(1), (d)(1) and pliance; or
(e)(1) of this section, for facility non- (ii) CMS or the State imposes a civil
compliance, instead of, or in addition money penalty for a deficiency that
to, termination of the provider agree- constitutes immediate jeopardy, the
ment, CMS does and the State must penalty must be in the upper range of
follow the criteria set forth in para- penalty amounts, as specified in
graphs (c)(2), (d)(2), and (e)(2) of this § 488.438(a).
section, as applicable. (e) Category 3. (1) Category 3 remedies
(c) Category 1. (1) Category 1 remedies include the following:
include the following: (i) Temporary management.
(i) Directed plan of correction. (ii) Immediate termination.
(ii) State monitoring. (iii) Civil money penalties of $3,050–
(iii) Directed in-service training. $10,000 as adjusted annually under 45
(2) CMS does or the State must apply CFR part 102 per day.
one or more of the remedies in Cat- (iv) Civil money penalty of $1,000–
egory 1 when there— $10,000 as adjusted annually under 45
(i) Are isolated deficiencies that con- CFR part 102 per instance of non-
stitute no actual harm with a potential compliance.
for more than minimal harm but not (2) When there are one or more defi-
immediate jeopardy; or ciencies that constitute immediate
(ii) Is a pattern of deficiencies that jeopardy to resident health or safety—
constitutes no actual harm with a po- (i) CMS does and the State must do
tential for more than minimal harm one or both of the following:
but not immediate jeopardy. (A) Impose temporary management;
(3) Except when the facility is in sub- or
stantial compliance, CMS or the State (B) Terminate the provider agree-
may apply one or more of the remedies ment;
in Category 1 to any deficiency. (ii) CMS and the State may impose a
(d) Category 2. (1) Category 2 remedies civil money penalty of $3,050–$10,000 as
include the following: adjusted annually under 45 CFR part
(i) Denial of payment for new admis- 102 per day or $1,000–$10,000 as adjusted
sions. annually under 45 CFR part 102 per in-
(ii) Denial of payment for all individ- stance of noncompliance, in addition to
uals imposed only by CMS. imposing the remedies specified in
(iii) Civil money penalties of $50–3,000 paragraph (e)(2)(i) of this section.
as adjusted annually under 45 CFR part (3) When there are widespread defi-
102 per day. ciencies that constitute actual harm
(iv) Civil money penalty of $1,000- that is not immediate jeopardy, CMS
$10,000 as adjusted annually under 45 and the State may impose temporary
CFR part 102 per instance of non- management, in addition to Category 2
compliance. remedies.
(2) CMS applies one or more of the (f) Plan of correction. (1) Except as
remedies in Category 2, or, except for specified in paragraph (f)(2) of this sec-
denial of payment for all individuals, tion, each facility that has a deficiency
the State must apply one or more of with regard to a requirement for long
the remedies in Category 2 when there term care facilities must submit a plan
are— of correction for approval by CMS or
(i) Widespread deficiencies that con- the State, regardless of—
stitute no actual harm with a potential (i) Which remedies are imposed; or
for more than minimal harm but not (ii) The seriousness of the defi-
immediate jeopardy; or ciencies.
(ii) One or more deficiencies that (2) When there are only isolated defi-
constitute actual harm that is not im- ciencies that CMS or the State deter-
mediate jeopardy. mines constitute no actual harm with
546
a potential for minimal harm, the fa- health or safety, CMS or the State
cility need not submit a plan of correc- must notify the other of such a finding.
tion. (2) CMS will or the State must do one
(g) Appeal of a certification of non- or both of the following:
compliance. (1) A facility may appeal a (i) Take immediate action to remove
certification of noncompliance leading the jeopardy and correct the non-
to an enforcement remedy. compliance through temporary man-
(2) A facility may not appeal the agement.
choice of remedy, including the factors (ii) Terminate the facility’s partici-
considered by CMS or the State in se- pation under the State plan. If this is
lecting the remedy, specified in done, CMS will also terminate the fa-
§ 488.404. cility’s participation in Medicare if it
is a dually participating facility.
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. (d) The State must provide for the
28, 1995, as amended at 64 FR 13360, Mar. 18, safe and orderly transfer of residents
1999; 81 FR 61563, Sept. 6, 2016] when the facility is terminated.
(e) If the immediate jeopardy is also
§ 488.410 Action when there is imme-
diate jeopardy. substandard quality of care, the State
survey agency must notify attending
(a) If there is immediate jeopardy to physicians and the State board respon-
resident health or safety, the State sible for licensing the facility adminis-
must (and CMS does) either terminate trator of the finding of substandard
the provider agreement within 23 cal- quality of care, as specified in
endar days of the last date of the sur- § 488.325(h).
vey or appoint a temporary manager to
remove the immediate jeopardy. The [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept.
28, 1995]
rules for appointment of a temporary
manager in an immediate jeopardy sit- § 488.412 Action when there is no im-
uation are as follows: mediate jeopardy.
(1) CMS does and the State must no- (a) If a facility’s deficiencies do not
tify the facility that a temporary man- pose immediate jeopardy to residents’
ager is being appointed. health or safety, and the facility is not
(2) If the facility fails to relinquish in substantial compliance, CMS or the
control to the temporary manager, State may terminate the facility’s pro-
CMS does and the State must termi- vider agreement or may allow the fa-
nate the provider agreement within 23 cility to continue to participate for no
calendar days of the last day of the longer than 6 months from the last day
survey, if the immediate jeopardy is of the survey if—
not removed. In these cases, State (1) The State survey agency finds
monitoring may be imposed pending that it is more appropriate to impose
termination. alternative remedies than to terminate
(3) If the facility relinquishes control the facility’s provider agreement;
to the temporary manager, the State (2) The State has submitted a plan
must (and CMS does) notify the facility and timetable for corrective action ap-
that, unless it removes the immediate proved by CMS; and
jeopardy, its provider agreement will (3) The facility in the case of a Medi-
be terminated within 23 calendar days care SNF or the State in the case of a
of the last day of the survey. Medicaid NF agrees to repay to the
(4) CMS does and the State must ter- Federal government payments received
minate the provider agreement within after the last day of the survey that
23 calendar days of the last day of sur- first identified the deficiencies if cor-
vey if the immediate jeopardy has not rective action is not taken in accord-
been removed. ance with the approved plan of correc-
(b) CMS or the State may also im- tion.
pose other remedies, as appropriate. (b) If a facility does not meet the cri-
(c)(1) In a NF or dually participating teria for continuation of payment
facility, if either CMS or the State under paragraph (a) of this section,
finds that a facility’s noncompliance CMS will and the State must terminate
poses immediate jeopardy to resident the facility’s provider agreement.
547
§ 488.414 42 CFR Ch. IV (10–1–17 Edition)
(c) CMS does and the State must Medicaid or both programs will be con-
deny payment for new admissions when sidered).
a facility is not in substantial compli- (2) Termination would allow the
ance 3 months after the last day of the count of repeated substandard quality
survey. of care surveys to start over.
(d) CMS terminates the provider (3) Change of ownership. (i) A facility
agreement for SNFs and NFs, and stops may not avoid a remedy on the basis
FFP to a State for a NF for which par- that it underwent a change of owner-
ticipation was continued under para- ship.
graph (a) of this section, if the facility (ii) In a facility that has undergone a
is not in substantial compliance within change of ownership, CMS does not and
6 months of the last day of the survey. the State may not restart the count of
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. repeated substandard quality of care
28, 1995] surveys unless the new owner can dem-
onstrate to the satisfaction of CMS or
§ 488.414 Action when there is re- the State that the poor past perform-
peated substandard quality of care. ance no longer is a factor due to the
(a) General. If a facility has been change in ownership.
found to have provided substandard (e) Facility alleges corrections or
quality of care on the last three con- achieves compliance after repeated sub-
secutive standard surveys, as defined in standard quality of care is identified. (1)
§ 488.305, regardless of other remedies If a penalty is imposed for repeated
provided— substandard quality of care, it will con-
(1) CMS imposes denial of payment tinue until the facility has dem-
for all new admissions, as specified in onstrated to the satisfaction of CMS or
§ 488.417, or denial of all payments, as the State that it is in substantial com-
specified in § 488.418; pliance with the requirements and that
(2) The State must impose denial of it will remain in substantial compli-
payment for all new admissions, as ance with the requirements for a period
specified in § 488.417; and of time specified by CMS or the State.
(3) CMS does and the State survey (2) A facility will not avoid the impo-
agency must impose State monitoring, sition of remedies or the obligation to
as specified in § 488.422, until the facil- demonstrate that it will remain in
ity has demonstrated to the satisfac- compliance when it—
tion of CMS or the State, that it is in (i) Alleges correction of the defi-
substantial compliance with all re- ciencies cited in the most recent stand-
quirements and will remain in substan- ard survey; or
tial compliance with all requirements.
(ii) Achieves compliance before the
(b) Repeated noncompliance. For pur-
effective date of the remedies.
poses of this section, repeated non-
compliance is based on the repeated § 488.415 Temporary management.
finding of substandard quality of care
and not on the basis that the substance (a) Definition. Temporary manage-
of the deficiency or the exact tag num- ment means the temporary appoint-
ber for the deficiency was repeated. ment by CMS or the State of a sub-
(c) Standard surveys to which this pro- stitute facility manager or adminis-
vision applies. Standard surveys com- trator with authority to hire, termi-
pleted by the State survey agency on nate or reassign staff, obligate facility
or after October 1, 1990, are used to de- funds, alter facility procedures, and
termine whether the threshold of three manage the facility to correct defi-
consecutive standard surveys is met. ciencies identified in the facility’s op-
(d) Program participation. (1) The de- eration.
termination that a certified facility (b) Qualifications. The temporary
has repeated instances of substandard manager must—
quality of care is made without regard (1) Be qualified to oversee correction
to any variances in the facility’s proof deficiencies on the basis of experi-

gram participation (that is, any stand- ence and education, as determined by
ard survey completed for Medicare, the State;
548
(2) Not have been found guilty of mis- (1) Medicare facilities. In the case of
conduct by any licensing board or pro- Medicare facilities, CMS may deny
fessional society in any State; payment to the facility.
(3) Have, or a member of his or her (2) Medicaid facilities. In the case of
immediate family have, no financial Medicaid facilities—
ownership interest in the facility; and (i) The State may deny payment to
(4) Not currently serve or, within the the facility; and
past 2 years, have served as a member (ii) CMS may deny payment to the
of the staff of the facility. State for all new Medicaid admissions
(c) Payment of salary. The temporary
to the facility.
manager’s salary—
(b) Required denial of payment. CMS
(1) Is paid directly by the facility
while the temporary manager is as- does or the State must deny payment
signed to that facility; and for all new admissions when—
(2) Must be at least equivalent to the (1) The facility is not in substantial
sum of the following— compliance, as defined in § 488.401, 3
(i) The prevailing salary paid by pro- months after the last day of the survey
viders for positions of this type in what identifying the noncompliance; or
the State considers to be the facility’s (2) The State survey agency has cited
geographic area; a facility with substandard quality of
(ii) Additional costs that would have care on the last three consecutive
reasonably been incurred by the pro- standard surveys.
vider if such person had been in an em- (c) Resumption of payments: Repeated
ployment relationship; and instances of substandard quality of care.
(iii) Any other costs incurred by such When a facility has repeated instances
a person in furnishing services under of substandard quality of care, pay-
such an arrangement or as otherwise ments to the facility or, under Med-
set by the State. icaid, CMS payments to the State on
(3) May exceed the amount specified behalf of the facility, resume on the
in paragraph (c)(2) of this section if the date that—
State is otherwise unable to attract a (1) The facility achieves substantial
qualified temporary manager. compliance as indicated by a revisit or
(d) Failure to relinquish authority to written credible evidence acceptable to
temporary management—(1) Termination CMS (for all facilities except non-State
of provider agreement. If a facility fails operated NFs against which CMS is im-
to relinquish authority to the tem- posing no remedies) or the State (for
porary manager as described in this non-State operated NFs against which
section, CMS will or the State must CMS is imposing no remedies); and
terminate the provider agreement in
(2) CMS (for all facilities except non-
accordance with § 488.456.
State operated NFs against which CMS
(2) Failure to pay salary of temporary
is imposing no remedies) or the State
manager. A facility’s failure to pay the
salary of the temporary manager is (for non-State operated NFs against
considered a failure to relinquish au- which CMS is imposing no remedies)
thority to temporary management. believes that the facility is capable of
(e) Duration of temporary management. remaining in substantial compliance.
Temporary management ends when the (d) Resumption of payments: No re-
facility meets any of the conditions peated instances of substandard quality of
specified in § 488.454(c). care. When a facility does not have re-
peated instances of substandard qual-
§ 488.417 Denial of payment for all new ity of care, payments to the facility or,
admissions. under Medicaid, CMS payments to the
(a) Optional denial of payment. Except State on behalf of the facility, resume
as specified in paragraph (b) of this sec- prospectively on the date that the fa-
tion, CMS or the State may deny pay- cility achieves substantial compliance,
ment for all new admissions when a fa- as indicated by a revisit or written
cility is not in substantial compliance credible evidence acceptable to CMS

with the requirements, as defined in (under Medicare) or the State (under
§ 488.401, as follows: Medicaid).
549
§ 488.418 42 CFR Ch. IV (10–1–17 Edition)
(e) Restriction. No payments to a fa- standard quality of care, payment is

cility or, under Medicaid, CMS pay- resumed when—
ments to the State on behalf of the fa- (1) The facility achieved substantial
cility, are made for the period between compliance, as indicated by a revisit or
the date that the— written credible evidence acceptable to
(1) Denial of payment remedy is im- CMS; and
posed; and (2) CMS believes that the facility will
(2) Facility achieves substantial com- remain in substantial compliance.
pliance, as determined by CMS or the
State. § 488.422 State monitoring.
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. (a) A State monitor—
28, 1995] (1) Oversees the correction of defi-
ciencies specified by CMS or the State
§ 488.418 Secretarial authority to deny survey agency at the facility site and
all payments. protects the facility’s residents from
(a) CMS option to deny all payment. If harm;
a facility has not met a requirement, (2) Is an employee or a contractor of
in addition to the authority to deny the survey agency;
payment for all new admissions as (3) Is identified by the State as an ap-
specified in § 488.417, CMS may deny propriate professional to monitor cited
any further payment for all Medicare deficiencies;
residents in the facility and to the (4) Is not an employee of the facility;
State for all Medicaid residents in the (5) Does not function as a consultant
facility. to the facility; and
(b) Prospective resumption of payment. (6) Does not have an immediate fam-
Except as provided in paragraphs (d) ily member who is a resident of the fa-
and (e) of this section, if the facility cility to be monitored.
achieves substantial compliance, CMS (b) A State monitor must be used
resumes payment prospectively from when a survey agency has cited a facil-
the date that it verifies as the date ity with substandard quality of care
that the facility achieved substantial deficiencies on the last 3 consecutive
compliance. standard surveys.
(c) Restriction on payment after denial (c) State monitoring is discontinued
of payment is imposed. If payment to the when—
facility or to the State resumes after (1) The facility has demonstrated
denial of payment for all residents, no that it is in substantial compliance
payment is made for the period be- with the requirements, and, if imposed
tween the date that— for repeated instances of substandard
(1) Denial of payment was imposed; quality of care, will remain in compli-
and ance for a period of time specified by
(2) CMS verifies as the date that the CMS or the State; or
facility achieved substantial compli- (2) Termination procedures are com-
ance. pleted.
(d) Retroactive resumption of payment.
Except when a facility has repeated in- [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
stances of substandard quality of care, 28, 1995]
as specified in paragraph (e) of this sec-
§ 488.424 Directed plan of correction.
tion, when CMS or the State finds that
the facility was in substantial compli- CMS, the State survey agency, or the
ance before the date of the revisit, or temporary manager (with CMS or
before CMS or the survey agency re- State approval) may develop a plan of
ceived credible evidence of such com- correction and CMS, the State, or the
pliance, payment is resumed on the temporary manager require a facility
date that substantial compliance was to take action within specified time-
achieved, as determined by CMS. frames.
(e) Resumption of payment—repeated
instances of substandard care. When § 488.425 Directed inservice training.

CMS denies payment for all Medicare (a) Required training. CMS or the
residents for repeated instances of sub- State agency may require the staff of a
550
facility to attend an inservice training whether or not the deficiencies con-

program if— stitute immediate jeopardy.
(1) The facility has a pattern of defi- (b) CMS or the State may impose a
ciencies that indicate noncompliance; civil money penalty for the number of
and days of past noncompliance since the
(2) Education is likely to correct the last standard survey, including the
deficiencies. number of days of immediate jeopardy.
(b) Action following training. After the
staff has received inservice training, if FR 13360, Mar. 18, 1999]
the facility has not achieved substan-
tial compliance, CMS or the State may § 488.431 Civil money penalties im-
impose one or more other remedies posed by CMS and independent in-
specified in § 488.406. formal dispute resolution: for SNFS,
(c) Payment. The facility pays for di- dually-participating SNF/NFs, and
rected inservice training. NF-only facilities.
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. (a) Opportunity for independent review.
28, 1995] CMS retains ultimate authority for the
survey findings and imposition of civil
§ 488.426 Transfer of residents, or clo- money penalties, but provides an op-
sure of the facility and transfer of portunity for independent informal dis-
residents. pute resolution within 30 days of notice
(a) Transfer of residents, or closure of of imposition of a civil money penalty
the facility and transfer of residents in an that will be placed in escrow in accord-
emergency. In an emergency, the State ance with paragraph (b) of this section.
has the authority to— An independent informal dispute reso-
(1) Transfer Medicaid and Medicare lution will—
residents to another facility; or (1) Be completed within 60 days of fa-
(2) Close the facility and transfer the cility’s request if an independent infor-
Medicaid and Medicare residents to an- mal dispute resolution is timely re-
other facility. quested by the facility.
(b) Required transfer when a facility’s (2) Generate a written record prior to
provider agreement is terminated. When the collection of the penalty.
the State or CMS terminates a facili- (3) Include notification to an in-
ty’s provider agreement, the State will volved resident or resident representa-
arrange for the safe and orderly trans- tive, as well as the State’s long term
fer of all Medicare and Medicaid resi- care ombudsman, to provide oppor-
dents to another facility, in accordance tunity for written comment.
with § 483.70(l) of this chapter. (4) Be approved by CMS and con-
(c) Required notifications when a facili- ducted by the State under section 1864
ty’s provider agreement is terminated. of the Act, or by an entity approved by
When the State or CMS terminates a the State and CMS, or by CMS or its
facility’s provider agreement, CMS de- agent in the case of surveys conducted
termines the appropriate date for noti- only by federal surveyors where the
fication, in accordance with § 483.70(l) State independent dispute resolution
of this chapter. process is not used, and which has no
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
conflict of interest, such as:
28, 1995, as amended at 76 FR 9511, Feb. 18, (i) A component of an umbrella State
2011; 81 FR 68872, Oct. 4, 2016] agency provided that the component is
organizationally separate from the
§ 488.430 Civil money penalties: Basis State survey agency.
for imposing penalty. (ii) An independent entity with a spe-
(a) CMS or the State may impose a cific understanding of Medicare and
civil money penalty for either the Medicaid program requirements se-
number of days a facility is not in sub- lected by the State and approved by
stantial compliance with one or more CMS.
participation requirements or for each (5) Not include the survey findings
instance that a facility is not in sub- that have already been the subject of
stantial compliance, regardless of an informal dispute resolution under
551
§ 488.432 42 CFR Ch. IV (10–1–17 Edition)
§ 488.331 for the particular deficiency cian escrow account under this section,
tations at issue in the independent CMS will collect such civil money pen-
process under § 488.431, unless the infor- alties in the same manner as the State
mal dispute resolution under § 488.331 in accordance with § 488.432.
was completed prior to the imposition (c) Maintenance of escrowed funds.
of the civil money penalty. CMS will maintain collected civil
(b) Collection and placement in escrow money penalties in an escrow account
account. (1) For both per day and per pending the resolution of any adminis-
instance civil money penalties, CMS trative appeal of the deficiency find-
may collect and place the imposed civil ings that comprise the basis for the
money penalties in an escrow account civil monetary penalty imposition.
on whichever of the following occurs CMS will retain the escrowed funds on
first: an on-going basis and, upon a final ad-
(i) The date on which the inde- ministrative decision, will either re-
pendent informal dispute resolution turn applicable funds in accordance
process is completed under paragraph with paragraph (d)(2) of this section or,
(a) of this section. in the case of an unsuccessful adminis-
(ii) The date that is 90 days after the trative appeal, will periodically dis-
date of the notice of imposition of the burse the funds to States or other enti-
penalty. ties in accordance with § 488.433.
(2) For collection and placement in (d) When a facility requests a hearing.
escrow accounts of per day civil money (1) A facility must request a hearing on
penalties, CMS may collect the portion the determination of the noncompli-
of the per day civil money penalty that ance that is the basis for imposition of
has accrued up to the time of collec- the civil money penalty as specified in
tion as specified in paragraph (b)(1) of § 498.40 of this chapter.
this section. CMS may make additional (2) If the administrative law judge re-
collections periodically until the full verses deficiency findings that com-
amount is collected, except that the prise the basis of a civil money penalty
full balance must be collected once the in whole or in part, the escrowed
facility achieves substantial compli- amounts continue to be held pending
ance or is terminated from the pro- expiration of the time for CMS to ap-
gram and CMS determines the final peal the decision or, where CMS does
amount of the civil money penalty im- appeal, a Departmental Appeals Board
posed. decision affirming the reversal of the
(3) CMS may provide for an escrow pertinent deficiency findings. Any col-
payment schedule that differs from the lected civil money penalty amount
collection times of paragraph (1) of this owed to the facility based on a final ad-
subsection in any case in which CMS ministrative decision will be returned
determines that more time is necessary to the facility with applicable interest
for deposit of the total civil money as specified in section 1878(f)(2) of the
penalty into an escrow account, not to Act.
exceed 12 months, if CMS finds that im- [76 FR 15126, Mar. 18, 2011]
mediate payment would create sub-
stantial and undue financial hardship § 488.432 Civil money penalties im-
on the facility. posed by the State: NF-only.
(4) If the full civil money penalty is (a) When a facility requests a hearing.
not placed in an escrow account within (1) When the State imposes a civil
30 calendar days from the date the pro- money penalty against a non-State op-
vider receives notice of collection, or erated NF that is not subject to impo-
within 30 calendar days of any due date sition of remedies by CMS, the facility
established pursuant to a hardship must request a hearing on the deter-
finding under paragraph (b)(3), CMS mination of noncompliance that is the
may deduct the amount of the civil basis for imposition of the civil money
money penalty from any sum then or penalty within the time specified in
later owed by CMS or the State to the § 431.153 of this chapter.
facility in accordance with § 488.442(c). (2)(i) If a facility requests a hearing

(5) For any civil money penalties within the time frame specified in
that are not collected and placed into paragraph (a)(1) of this section, for a
552
civil money penalty imposed per day, (2) Waives its right to a hearing in
the State initiates collection of the writing, are specified in §§ 488.436(b) and
penalty when there is a final adminis- 488.440.
trative decision that upholds the
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
State’s determination of noncompli- 28, 1995, as amended at 64 FR 13360, Mar. 18,
ance after the facility achieves sub- 1999; 76 FR 15127, Mar. 18, 2011]
stantial compliance or is terminated.
(ii) If a facility requests a hearing for § 488.433 Civil money penalties: Uses
a civil money penalty imposed per in- and approval of civil money pen-
stance of noncompliance within the alties imposed by CMS.
time specified in paragraph (a)(1) of (a) Ten percent of the collected civil
this section, the State initiates collec- money penalty funds that are required
tion of the penalty when there is a to be held in escrow pursuant to
final administrative decision that up- § 488.431 and that remain after a final
holds the State’s determination of non- administrative decision will be depos-
compliance. ited with the Department of the Treas-
(b) When a facility does not request a ury in accordance with § 488.442(f). The
hearing for a civil money penalty im- remaining ninety percent of the col-
posed per day. (1) If a facility does not lected civil money penalty funds that
request a hearing in accordance with are required to be held in escrow pursu-
paragraph (a) of this section, the State ant to § 488.431 and that remain after a
initiates collection of the penalty when final administrative decision must be
the facility— used entirely for activities that protect
(i) Achieves substantial compliance; or improve the quality of care or qual-
or ity of life for residents consistent with
(ii) Is terminated. paragraph (b) of this section and may
(2) When a facility does not request a not be used for survey and certification
hearing for a civil money penalty imposed operations or State expenses, except
per instance of noncompliance. If a facil- that reasonable expenses necessary to
administer, monitor, or evaluate the
ity does not request a hearing in ac-
effectiveness of projects utilizing civil
cordance with paragraph (a) of this sec-
money penalty funds may be per-
tion, the State initiates collection of
mitted.
the penalty when the time frame for
(b) All activities and plans for uti-
requesting a hearing expires.
lizing civil money penalty funds, in-
(c) When a facility waives a hearing.
cluding any expense used to administer
(1) If a facility waives, in writing, its
grants utilizing civil money penalty
right to a hearing as specified in funds, must be approved in advance by
§ 488.436, for a civil money penalty im- CMS and may include, but are not lim-
posed per day, the State initiates col- ited to:
lection of the penalty when the facil- (1) Support and protection of resi-
ity— dents of a facility that closes (volun-
(i) Achieves substantial compliance; tarily or involuntarily).
or (ii) Is terminated. (2) Time-limited expenses incurred in
(2) If a facility waives, in writing, its the process of relocating residents to
right to a hearing as specified in home and community-based settings or
§ 488.436, the State initiates collection another facility when a facility is
of civil money penalty imposed per in- closed (voluntarily or involuntarily) or
stance of noncompliance upon receipt downsized pursuant to an agreement
of the facility’s notification. with the State Medicaid agency.
(d) Accrual and computation of pen- (3) Projects that support resident and
alties for a facility that— family councils and other consumer in-
(1) Requests a hearing or does not re- volvement in assuring quality care in
quest a hearing are specified in facilities.
§ 488.440; (4) Facility improvement initiatives,

such as joint training of facility staff
and surveyors or technical assistance
553
§ 488.434 42 CFR Ch. IV (10–1–17 Edition)
for facilities implementing quality as- (f) If CMS finds that a State has not
surance and performance improvement spent civil money penalty funds in ac-
programs. cordance with this section, or fails to
(5) Development and maintenance of make use of funds to benefit the qual-
temporary management or receivership ity of care or life of residents, or fails
capability such as but not limited to, to maintain an acceptable plan for the
recruitment, training, retention or use of funds that is approved by CMS,
other system infrastructure expenses. then CMS may withhold future dis-
However, as specified in § 488.415(c), a bursements of civil money penalty
temporary manager’s salary must be funds to the State until the State has
paid by the facility. In rare situations, submitted an acceptable plan to com-
if the facility is closing, CMS plans to ply with this section.
stop or suspend continued payments to
[79 FR 45658, Aug. 5, 2014]
the facility under § 489.55 of this chap-
ter during the temporary manager’s § 488.434 Civil money penalties: Notice
duty period, and CMS determines that of penalty.
extraordinary action is necessary to
(a) CMS notice of penalty. (1) CMS
protect the residents until relocation
sends a written notice of the penalty to
efforts are successful, civil money pen-
the facility for all facilities except
alty funds may be used to pay the man-
non-State operated NFs when the State
ager’s salary.
is imposing the penalty.
(c) At a minimum, proposed activi-
(2) Content of notice. The notice that
ties submitted to CMS for prior ap-
CMS sends includes—
proval must include a description of
(i) The nature of the noncompliance;
the intended outcomes, deliverables,
and sustainability; and a description of (ii) The statutory basis for the pen-
the methods by which the activity re- alty;
sults will be assessed, including spe- (iii) The amount of penalty per day of
cific measures. noncompliance or the amount of the
(d) Civil money penalty funds may penalty per instance of noncompliance;
not be used for activities that have (iv) Any factors specified in
been disapproved by CMS. § 488.438(f) that were considered when
(e) The State must maintain an ac- determining the amount of the pen-
ceptable plan, approved by CMS, for alty;
the effective use of civil money funds, (v) The date of the instance of non-
including a description of methods by compliance or the date on which the
which the State will: penalty begins to accrue;
(1) Solicit, accept, monitor, and (vi) When the penalty stops accruing,
track projects utilizing civil money if applicable;
penalty funds including any funds used (vii) When the penalty is collected;
for state administration. and
(2) Make information about the use (viii) Instructions for responding to
of civil money penalty funds publicly the notice, including a statement of
available, including about the dollar the facility’s right to a hearing, and
amount awarded for approved projects, the implication of waiving a hearing,
the grantee or contract recipients, the as provided in § 488.436.
results of projects, and other key infor- (b) State notice of penalty. (1) The
mation. State must notify the facility in ac-
(3) Ensure that: cordance with State procedures for all
(i) A core amount of civil money pen- non-State operated NFs when the State
alty funds will be held in reserve for takes the action.
emergencies, such as relocation of resi- (2) The State’s notice must—
dents pursuant to an involuntary ter- (i) Be in writing; and
mination from Medicare and Medicaid. (ii) Include, at a minimum, the infor-
(ii) A reasonable amount of funds, be- mation specified in paragraph (a)(2) of
yond those held in reserve under para- this section.
graph (e)(3)(i) of this section, will be [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
awarded or contracted each year for 28, 1995, as amended at 64 FR 13360, Mar. 18,
the purposes specified in this section. 1999]
554
§ 488.436 Civil money penalties: Waiv- penalty amount imposed per day to the
er of hearing, reduction of penalty lower range.
amount. (2) When CMS determines that a
(a) Waiver of a hearing. The facility SNF, dually-participating SNF/NF, or
may waive the right to a hearing, in NF-only facility subject to a civil
writing, within 60 days from the date of money penalty imposed by CMS self-re-
the notice imposing the civil money ports and promptly corrects the non-
penalty. compliance for which the civil money
(b) Reduction of penalty amount. (1) If penalty was imposed, CMS will reduce
the facility waives its right to a hear- the amount of the penalty by 50 per-
ing in accordance with the procedures cent, provided that all of the following
specified in paragraph (a) of this sec- apply —
tion, CMS or the State reduces the (i) The facility self-reported the non-
civil money penalty by 35 percent, as compliance to CMS or the State before
long as the civil money penalty has not it was identified by CMS or the State
also been reduced by 50 percent under and before it was reported to CMS or
§ 488.438. the State by means of a complaint
(2) If the facility does not waive its lodged by a person other than an offi-
right to a hearing in accordance with cial representative of the nursing
the procedures specified in paragraph home;
(a) of this section, the civil money pen- (ii) Correction of the self-reported
alty is not reduced by 35 percent. noncompliance occurred on whichever
[59 FR 56243, Nov. 10, 1994; 62 FR 44221, Aug. of the following occurs first:
20, 1997; 76 FR 15127, Mar. 18, 2011] (A) 15 calendar days from the date of
the circumstance or incident that later
§ 488.438 Civil money penalties: resulted in a finding of noncompliance;
Amount of penalty. or
(a) Amount of penalty. (1) The pen- (B) 10 calendar days from the date
alties are within the following ranges, the civil money penalty was imposed;
set at $50 increments: (iii) The facility waives its right to a
(i) Upper range. Penalties in the hearing under § 488.436;
range of $3,050–$10,000 as adjusted annu- (iv) The noncompliance that was self-
ally under 45 CFR part 102 per day are reported and corrected did not con-
imposed for deficiencies constituting stitute a pattern of harm, widespread
immediate jeopardy, and as specified in harm, immediate jeopardy, or result in
paragraph (d)(2) of this section. the death of a resident;
(ii) Upper range. Penalties in the (v) The civil money penalty was not
range of $50–$3,000 as adjusted annually imposed for a repeated deficiency, as
under 45 CFR part 102 per day are im- defined in paragraph (d)(3) of this sec-
posed for deficiencies that do not con- tion, that was the basis of a civil
stitute immediate jeopardy, but either money penalty that previously re-
caused actual harm, or caused no ac- ceived a reduction under this section;
tual harm, but have the potential for and
more than minimal harm. (vi) The facility has met mandatory
(2) Per instance penalty. When pen- reporting requirements for the incident
alties are imposed for an instance of or circumstance upon which the civil
noncompliance, the penalties will be in money penalty is based, as required by
the range of $1,000-$10,000 as adjusted Federal and State law.
annually under 45 CFR part 102 per in- (3) Under no circumstances will a fa-
stance. cility receive both the 50 percent civil
(b) Basis for penalty amount. The money penalty reduction for self-re-
amount of penalty is based on CMS’s or porting and correcting under this sec-
the State’s assessment of factors listed tion and the 35 percent civil money
in paragraph (f) of this section. penalty reduction for waiving its right
(c) Decreased penalty amounts. (1) Ex- to a hearing under § 488.436.
cept as specified in paragraph (d)(2) of (d) Increased penalty amounts. (1) Be-
this section, if immediate jeopardy is fore a hearing requested in accordance

removed, but the noncompliance con- with § 488.431(d) or § 488.432(a), CMS or
tinues, CMS or the State will shift the the State may propose to increase the
555
§ 488.440 42 CFR Ch. IV (10–1–17 Edition)
per day penalty amount for facility § 488.440 Civil money penalties: Effec-
noncompliance which, after imposition tive date and duration of penalty.
of a lower level penalty amount, be- (a)(1) The per day civil money pen-
comes sufficiently serious to pose im- alty may start accruing as early as the
mediate jeopardy. date that the facility was first out of
(2) CMS does and the State must in- compliance, as determined by CMS or
crease the per day penalty amount for the State.
any repeated deficiencies for which a (2) A civil money penalty for each in-
lower level penalty amount was pre- stance of noncompliance is imposed in
viously imposed, regardless of whether a specific amount for that particular
the increased penalty amount would deficiency .
exceed the range otherwise reserved for (b) The per day civil money penalty
nonimmediate jeopardy deficiencies. is computed and collectible, as speci-
(3) Repeated deficiencies are defi- fied in §§ 488.431, 488.432, and 488.442 for
ciencies in the same regulatory group- the number of days of noncompliance
ing of requirements found at the last until the date the facility achieves sub-
survey, subsequently corrected, and stantial compliance, or, if applicable,
found again at the next survey. the date of termination when —
(e) Review of the penalty. When an ad- (1) The determination of noncompli-
ministrative law judge or State hear- ance is upheld after a final administra-
ing officer (or higher administrative tive decision for NFs-only subject to
review authority) finds that the basis civil money penalties imposed by the
state or for civil money penalties im-
for imposing a civil money penalty ex-
posed by CMS that are not collected
ists, as specified in § 488.430, the admin-
and placed into an escrow account;
istrative law judge or State hearing of-
(2) The facility waives its right to a
ficer (or higher administrative review
hearing in accordance with § 488.436; or
authority) may not— (3) The time for requesting a hearing
(1) Set a penalty of zero or reduce a has expired and CMS or the State has
penalty to zero; not received a hearing request from the
(2) Review the exercise of discretion facility.
by CMS or the State to impose a civil (c)(1) For NFs-only subject to civil
money penalty; and money penalties imposed by the State
(3) Consider any factors in reviewing and for civil money penalties imposed
the amount of the penalty other than by CMS that may not be placed in an
those specified in paragraph (f) of this escrow account, the entire penalty,
section. whether imposed on a per day or per in-
(f) Factors affecting the amount of pen- stance basis, is due and collectible as
alty. In determining the amount of pen- specified in the notice sent to the pro-
alty, CMS does or the State must take vider under paragraphs (d) and (e) of
into account the following factors: this section.
(1) The facility’s history of non- (2) For SNFs, dually-participating
compliance, including repeated defi- SNF/NFs, or NFs subject to civil
ciencies. money penalties imposed by CMS, col-
(2) The facility’s financial condition. lection is made in accordance with
§ 488.431.
(3) The factors specified in § 488.404.
(d)(1) When a civil money penalty is
(4) The facility’s degree of culpability. imposed on a per day basis and the fa-
Culpability for purposes of this para- cility achieves substantial compliance,
graph includes, but is not limited to, CMS does or the State must send a sep-
neglect, indifference, or disregard for arate notice to the facility containing
resident care, comfort or safety. The the following information:
absence of culpability is not a miti- (i) The amount of penalty per day.
gating circumstance in reducing the (ii) The number of days involved.
amount of the penalty. (iii) The total amount due.
[59 FR 56243, Nov. 10, 1994, as amended at 64 (iv) The due date of the penalty.
FR 13360, Mar. 18, 1999; 68 FR 46072, Aug. 4, (v) The rate of interest assessed on
2003; 76 FR 15127, Mar. 18, 2011; 81 FR 61563, the unpaid balance beginning on the
Sept. 6, 2016] due date, as provided in § 488.442.
556
(2) When a civil money penalty is im- visit, penalties imposed on a per day
posed for an instance of noncompli- basis only accrue until that date of
ance, CMS does or the State must send correction for which there is written
a separate notice to the facility con- credible evidence.
taining the following information: (2) If an on-site revisit is not nec-
(i) The amount of the penalty. essary to confirm substantial compli-
(ii) The total amount due. ance, penalties imposed on a per day
(iii) The due date of the penalty. basis only accrue until the date of cor-
(iv) The rate of interest assessed on rection for which CMS or the State re-
the unpaid balance beginning on the ceives and accepts written credible evi-
due date, as provided in § 488.442. dence.
(e) In the case of a facility for which
the provider agreement has been termi-
FR 13361, Mar. 18, 1999; 76 FR 15128, Mar. 18,
nated and on which a civil money pen- 2011]
alty was imposed on a per day basis,
CMS does or the State must send this § 488.442 Civil money penalties: Due
penalty information after the— date for payment of penalty.
(1) Final administrative decision is
(a) When payments are due for a civil
made;
money penalty. (1) Payment for a civil
(2) Facility has waived its right to a
money penalty is due in accordance
hearing in accordance with § 488.436; or
with § 488.431 of this chapter for CMS-
(3) Time for requesting a hearing has
imposed penalties and 15 days after the
expired and CMS or the state has not
State initiates collection pursuant to
received a hearing request from the fa-
§ 488.432 of this chapter for State-im-
cility.
posed penalties, except as provided in
(f) Accrual of penalties when there is no
paragraphs (a)(2) and (3) of this section.
immediate jeopardy. (1) In the case of
(2) After a request to waive a hearing or
noncompliance that does not pose im-
when a hearing was not requested. Ex-
mediate jeopardy, the daily accrual of
cept as provided for in § 488.431, a civil
per day civil money penalties is im-
money penalty is due 15 days after re-
posed for the days of noncompliance
ceipt of a written request to waive a
prior to the notice specified in § 488.434
hearing in accordance with § 488.436 or
and an additional period of no longer
15 days after the time period for re-
than 6 months following the last day of
questing a hearing has expired and a
the survey.
hearing request was not received when:
(2) After the period specified in para-
graph (f)(1) of this section, if the facil- (i) The facility achieved substantial
ity has not achieved substantial com- compliance before the hearing request
pliance, CMS terminates the provider was due; or
agreement and the State may termi- (ii) The effective date of termination
nate the provider agreement. occurs before the hearing request was
(g)(1) In a case when per day civil due.
money penalties are imposed, when a (3) After the effective date of termi-
facility has deficiencies that pose im- nation. A civil money penalty payment
mediate jeopardy, CMS does or the is due 15 days after the effective date of
State must terminate the provider termination, if that date is earlier than
agreement within 23 calendar days the date specified in paragraph (a)(1)of
after the last day of the survey if the this section.
immediate jeopardy remains. (b) [Reserved]
(2) The accrual of the civil money (c) Deduction of penalty from amount
penalty imposed on a per day basis owed. The amount of the penalty, when
stops on the day the provider agree- determined, may be deducted from any
ment is terminated. sum then or later owing by CMS or the
(h)(1) If an on-site revisit is necessary State to the facility.
to confirm substantial compliance and (d) Interest—(1) Assessment. Interest is
the provider can supply documentation assessed on the unpaid balance of the
acceptable to CMS or the State agency penalty, beginning on the due date.
that substantial compliance was (2) Medicare interest. Medicare rate of
achieved on a date preceding the re- interest is the higher of—
557
§ 488.444 42 CFR Ch. IV (10–1–17 Edition)
(i) The rate fixed by the Secretary of State-operated facilities, or other fa-
the Treasury after taking into consid- cilities for which CMS’s enforcement
eration private consumer rates of in- action prevails, in accordance with
terest prevailing on the date of the no- § 488.330.
tice of the penalty amount due (pub- (b) The State has the authority to
lished quarterly in the FEDERAL REG- settle cases at any time prior to the
ISTER by HHS under 45 CFR 30.13(a)); or evidentiary hearing decision for all
(ii) The current value of funds (pub- cases in which the State’s enforcement
lished annually in the FEDERAL REG- action prevails.
ISTER by the Secretary of the Treasury,
subject to quarterly revisions). § 488.446 Administrator sanctions:
(3) Medicaid interest. The interest rate long-term care facility closures.
for Medicaid is determined by the Any individual who is or was the ad-
State. ministrator of a facility and fails or
(e) Penalties collected by CMS. Civil failed to comply with the requirements
money penalties and corresponding in- at § 483.70(l) of this chapter—
terest collected by CMS from— (a) Will be subject to a civil mone-
(1) Medicare-participating facilities tary penalty as follows:
are deposited and disbursed in accord- (1) A minimum of $500 as adjusted an-
ance with § 488.433; and nually under 45 CFR part 102 for the
(2) Medicaid-participating facilities first offense.
are returned to the State. (2) A minimum of $1,500 as adjusted
(f) Collection from dually participating annually under 45 CFR part 102 for the
facilities. Civil money penalties col- second offense.
lected from dually participating facili- (3) A minimum of $3,000 as adjusted
ties are deposited and disbursed in ac- annually under 45 CFR part 102 for the
cordance with § 488.433 and returned to third and subsequent offenses.
the State in proportion commensurate (b) May be subject to exclusion from
with the relative proportions of Medi- participation in any Federal health
care and Medicaid beds at the facility care program (as defined in section
actually in use by residents covered by 1128B(f) of the Act); and
the respective programs on the date (c) Will be subject to any other pen-
the civil money penalty begins to ac- alties that may be prescribed by law.
crue. [76 FR 9511, Feb. 18, 2011, as amended at 81
(g) Penalties collected by the State. FR 61563, Sept. 6, 2016; 81 FR 68872, Oct. 4,
Civil money penalties collected by the 2016]
State must be applied to the protection
of the health or property of residents of § 488.450 Continuation of payments to
facilities that the State or CMS finds a facility with deficiencies.
noncompliant, such as— (a) Criteria. (1) CMS may continue
(1) Payment for the cost of relocating payments to a facility not in substan-
residents to other facilities; tial compliance for the periods speci-
(2) State costs related to the oper- fied in paragraph (c) of this section if
ation of a facility pending correction of the following criteria are met:
deficiencies or closure; and (i) The State survey agency finds
(3) Reimbursement of residents for that it is more appropriate to impose
personal funds or property lost at a fa- alternative remedies than to terminate
cility as a result of actions by the fa- the facility;
cility or by individuals used by the fa- (ii) The State has submitted a plan
cility to provide services to residents. and timetable for corrective action ap-
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. proved by CMS; and
28, 1995, as amended at 64 FR 13361, Mar. 18, (iii) The facility, in the case of a
1999; 76 FR 15128, Mar. 18, 2011] Medicare SNF, or the State, in the case
of a Medicaid NF, agrees to repay the
§ 488.444 Civil money penalties: Settle- Federal government payments received
ment of penalties. under this provision if corrective ac-
(a) CMS has authority to settle cases tion is not taken in accordance with
at any time prior to a final administra- the approved plan and timetable for
tive decision for Medicare-only SNFs, corrective action.
558
(2) CMS or the State may terminate § 488.452 State and Federal disagree-
the SNF or NF agreement before the ments involving findings not in
end of the correction period if the cri- agreement in non-State operated
teria in paragraph (a)(1) of this section NFs and dually participating facili-
ties when there is no immediate
are not met. jeopardy.
(b) Cessation of payments. If termi-
nation is not sought, either by itself or The following rules apply when CMS
and the State disagree over findings of
along with another remedy or rem-
noncompliance or application of rem-
edies, or any of the criteria set forth in
edies in a non-State operated NF or du-
paragraph (a)(1) of this section are not
ally participating facility:
met or agreed to by either the facility (a) Disagreement over whether facility
or the State, the facility or State will has met requirements. (1) The State’s
receive no Medicare or Federal Med- finding of noncompliance takes prece-
icaid payments, as applicable, from the dence when—
last day of the survey. (i) CMS finds that a NF or a dually
(c) Period of continued payments—(1) participating facility is in substantial
Non-compliance. If the conditions in compliance with the participation re-
paragraph (a)(1) of this section are met, quirements; and
CMS may continue payments to a (ii) The State finds that a NF or du-
Medicare facility or the State for a ally participating facility has not
Medicaid facility with noncompliance achieved substantial compliance.
that does not constitute immediate (2) CMS’s findings of noncompliance
jeopardy for up to 6 months from the take precedence when—
last day of the survey. (i) CMS finds that a NF or a dually
(2) Facility closure. In the case of a fa- participating facility has not achieved
cility closure, the Secretary may, as substantial compliance; and
the Secretary determines appropriate, (ii) The State finds that a NF or a du-
continue to make payments with re- ally participating facility is in sub-
spect to residents of a long-term care stantial compliance with the participa-
tion requirements.
facility that has submitted a notifica-
(3) When CMS’s survey findings take
tion of closure during the period begin-
precedence, CMS may—
ning on the date such notification is
(i) Impose any of the alternative
submitted to CMS and ending on the remedies specified in § 488.406;
date on which the residents are suc- (ii) Terminate the provider agree-
cessfully relocated. ment subject to the applicable condi-
(d) Failure to achieve substantial com- tions of § 488.450; and
pliance. If the facility does not achieve (iii) Stop FFP to the State for a NF.
substantial compliance by the end of (b) Disagreement over decision to termi-
the period specified in paragraph (c) of nate. (1) CMS’s decision to terminate
this section, the participation of a facility takes
(1) CMS will— precedence when—
(i) Terminate the provider agreement (i) Both CMS and the State find that
of the Medicare SNF in accordance the facility has not achieved substan-
with § 488.456; or tial compliance; and
(ii) Discontinue Federal funding to (ii) CMS, but not the State, finds
the SNF for Medicare; and that the facility’s participation should
(iii) Discontinue FFP to the State for be terminated. CMS will permit con-
the Medicaid NF. tinuation of payment during the period
prior to the effective date of termi-
(2) The State may terminate the pro-
nation not to exceed 6 months, if the
vider agreement for the NF. applicable conditions of § 488.450 are
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. met.
28, 1995, as amended at 76 FR 9511, Feb. 18, (2) The State’s decision to terminate
2011; 78 FR 16805, Mar. 19, 2013] a facility’s participation and the proce-
dures for appealing such termination,

as specified in § 431.153(c) of this chap-
ter, takes precedence when—
559
§ 488.454 42 CFR Ch. IV (10–1–17 Edition)
(i) The State, but not CMS, finds that (1) CMS or the State determines that
a NF’s participation should be termi- the facility has achieved substantial
nated; and compliance and is capable of remaining
(ii) The State’s effective date for the in substantial compliance; or
termination of the NF’s provider agree- (2) CMS or the State terminates the
ment is no later than 6 months after provider agreement.
the last day of survey. (c) In the case of temporary manage-
(c) Disagreement over timing of termi- ment, the remedy continues until—
nation of facility. The State’s timing of (1) CMS or the State determines that
termination takes precedence if it does the facility has achieved substantial
not occur later than 6 months after the compliance and is capable of remaining
last day of the survey when both CMS in substantial compliance;
and the State find that— (2) CMS or the State terminates the
(1) A facility is not in substantial provider agreement; or
compliance; and (3) The facility which has not
(2) The facility’s participation should achieved substantial compliance re-
be terminated. assumes management control. In this
(d) Disagreement over remedies. (1) case, CMS or the State initiates termi-
When CMS or the State, but not both, nation of the provider agreement and
establishes one or more remedies, in may impose additional remedies.
addition to or as an alternative to ter- (d) In the case of a civil money pen-
mination, the additional or alternative alty imposed for an instance of non-
remedies will also apply when— compliance, the remedy is the specific
(i) Both CMS and the State find that amount of the civil money penalty im-
a facility has not achieved substantial posed for the particular deficiency.
compliance; and
(e) If the facility can supply docu-
(ii) Both CMS and the State find that
mentation acceptable to CMS or the
no immediate jeopardy exists.
State survey agency that it was in sub-
(2) Overlap of remedies. When CMS and
stantial compliance and was capable of
the State establish one or more rem-
remaining in substantial compliance, if
edies, in addition to or as an alter-
necessary, on a date preceding that of
native to termination, only the CMS
the revisit, the remedies terminate on
remedies apply when both CMS and the
the date that CMS or the State can
State find that a facility has not
verify as the date that substantial
achieved substantial compliance.
compliance was achieved and the facil-
(e) Regardless of whether CMS’s or
ity demonstrated that it could main-
the State’s decision controls, only one
tain substantial compliance, if nec-
noncompliance and enforcement deci-
essary.
sion is applied to the Medicaid agree-
ment, and for a dually participating fa- [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
cility, that same decision will apply to 28, 1995, as amended at 64 FR 13361, Mar. 18,
the Medicare agreement. 1999]
§ 488.454 Duration of remedies. § 488.456 Termination of provider

agreement.
(a) Except as specified in paragraphs
(b) and (d) of this section, alternative (a) Effect of termination. Termination
remedies continue until— of the provider agreement ends—
(1) The facility has achieved substan- (1) Payment to the facility; and
tial compliance, as determined by CMS (2) Any alternative remedy.
or the State based upon a revisit or (b) Basis for termination. (1) CMS and
after an examination of credible writ- the State may terminate a facility’s
ten evidence that it can verify without provider agreement if a facility—
an on-site visit; or (i) Is not in substantial compliance
(2) CMS or the State terminates the with the requirements of participation,
provider agreement. regardless of whether or not immediate
(b) In the cases of State monitoring jeopardy is present; or
and denial of payment imposed for re- (ii) Fails to submit an acceptable
peated substandard quality of care, plan of correction within the time-
remedies continue until— frame specified by CMS or the State.
560
(2) CMS and the State terminate a fa- sonable and appropriate efforts to meet
cility’s provider agreement if a facil- that condition.
ity— (c) If termination of coverage is
(i) Fails to relinquish control to the based on failure to meet any of the
temporary manager, if that remedy is other conditions specified in part 494 of
imposed by CMS or the State; or this chapter, coverage will not be rein-
(ii) Does not meet the eligibility cri- stated until CMS finds that the reason
teria for continuation of payment as for termination has been removed and
set forth in § 488.412(a)(1). there is reasonable assurance that it
(c) Notice of termination. Before termi- will not recur.
nating a provider agreement, CMS does
and the State must notify the facility § 488.606 Alternative sanctions.
and the public— (a) Basis for application of alternative
(1) At least 2 calendar days before the sanctions. CMS may, as an alternative
effective date of termination for a fa- to termination of Medicare coverage,
cility with immediate jeopardy defi- impose one of the sanctions specified in
ciencies; and paragraph (b) of this section if CMS
(2) At least 15 calendar days before finds that—
the effective date of termination for a (1) The supplier fails to participate in
facility with non-immediate jeopardy the activities and pursue the goals of
deficiencies that constitute noncompli- the ESRD network that is designated
ance. to encompass the supplier’s geographic
(d) Procedures for termination. (1) CMS area; and
terminates the provider agreement in (2) This failure does not jeopardize
accordance with procedures set forth in patient health and safety.
§ 489.53 of this chapter; and (b) Alternative sanctions. The alter-
(2) The State must terminate the native sanctions that CMS may apply
provider agreement of a NF in accord- in the circumstances specified in para-
ance with procedures specified in parts graph (a) of this section include the fol-
431 and 442 of this chapter. lowing:
(1) Denial of payment for services
Subpart G [Reserved] furnished to patients first accepted for
care after the effective date of the
Subpart H—Termination of Medi- sanction as specified in the sanction
notice.
care Coverage and Alter- (2) Reduction of payments, for all
native Sanctions for End- ESRD services furnished by the sup-
Stage Renal Disease (ESRD) plier, by 20 percent for each 30-day pe-
Facilities riod after the effective date of the
sanction.
SOURCE: 73 FR 20475, Apr. 15, 2008, unless (3) Withholding of all payments,
otherwise noted. without interest, for all ESRD services
furnished by the supplier to Medicare
§ 488.604 Termination of Medicare cov- beneficiaries.
erage. (c) Duration of alternative sanction. An
(a) Except as otherwise provided in alternative sanction remains in effect
this subpart, failure of a supplier of until CMS finds that the supplier is in
ESRD services to meet one or more of substantial compliance with the re-
the conditions for coverage set forth in quirement to cooperate in the network
part 494 of this chapter will result in plans and goals, or terminates coverage
termination of Medicare coverage of of the supplier’s services for lack of
the services furnished by the supplier. compliance.
(b) If termination of coverage is
based solely on a supplier’s failure to § 488.608 Notice of alternative sanction
participate in network activities and and appeal rights: Termination of
pursue network goals, as required at coverage.
§ 494.180(i) of this chapter, coverage (a) Notice of alternative sanction. CMS

may be reinstated when CMS deter- gives the supplier and the general pub-
mines that the supplier is making rea- lic notice of the alternative sanction
561
§ 488.610 42 CFR Ch. IV (10–1–17 Edition)
and of the effective date of the sanc- Abbreviated standard survey means a
tion. The effective date of the alter- focused survey other than a standard
native sanction is at least 30 days after survey that gathers information on an
the date of the notice. HHA’s compliance with fewer specific
(b) Appeal rights. Termination of standards or conditions of participa-
Medicare coverage of a supplier’s tion. An abbreviated standard survey
ESRD services because the supplier no may be based on complaints received, a
longer meets the conditions for cov- change of ownership or management,
erage of its services is an initial deter- or other indicators of specific concern
mination appealable under part 498 of such as reapplication for Medicare bill-
this chapter. ing privileges following a deactivation.
Complaint survey means a survey that
§ 488.610 Notice of appeal rights: Alter- is conducted to investigate specific al-
native sanctions.
legations of noncompliance.
If CMS proposes to apply an alter- Condition-level deficiency means non-
native sanction specified in § 488.606(b), compliance as described in § 488.24 of
the following rules apply: this part.
(a) CMS gives the facility notice of Deficiency is a violation of the Act
the proposed alternative sanction and and regulations contained in part 484,
15 days in which to request a hearing. subparts A through C of this chapter, is
(b) If the facility requests a hearing, determined as part of a survey, and can
CMS provides an informal hearing by a be either standard or condition-level.
CMS official who was not involved in
Extended survey means a survey that
making the appealed decision.
reviews additional conditions of par-
(c) During the informal hearing, the
ticipation not examined during a
facility—
standard survey. It may be conducted
(1) May be represented by counsel; at any time but must be conducted
(2) Has access to the information on when substandard care is identified.
which the allegation was based; and
Noncompliance means any deficiency
(3) May present, orally or in writing,
found at the condition-level or stand-
evidence and documentation to refute
ard-level.
the finding of failure to participate in
network activities and pursue network Partial extended survey means a sur-
goals. vey conducted to determine if defi-
(d) If the written decision of the in- ciencies and/or deficient practice(s)
formal hearing supports application of exist that were not fully examined dur-
the alternative sanction, CMS provides ing the standard survey. The surveyors
the facility and the public, at least 30 may review any additional require-
days before the effective date of the al- ments which would assist in making a
ternative sanction, a written notice compliance finding.
that specifies the effective date and the Standard-level deficiency means non-
reasons for the alternative sanction. compliance with one or more of the
standards that make up each condition
of participation for HHAs.
Subpart I—Survey and Certifi- Standard survey means a survey con-
cation of Home Health Agen- ducted in which the surveyor reviews
cies the HHA’s compliance with a select
number of standards and/or conditions
SOURCE: 77 FR 67164, Nov. 8, 2012, unless of participation in order to determine
otherwise noted. the quality of care and services fur-
nished by an HHA as measured by indi-
§ 488.700 Basis and scope. cators related to medical, nursing, and
Section 1891 of the Act establishes re- rehabilitative care.
quirements for surveying HHAs to de- Substandard care means noncompli-
termine whether they meet the Medi- ance with one or more conditions of
care conditions of participation. participation identified on a standard
survey, including deficiencies which

§ 488.705 Definitions. could result in actual or potential
As used in this subpart— harm to patients of an HHA.
562
Substantial compliance means compli- (2) To determine whether the HHA is

ance with all condition-level require- in compliance with one or more or all
ments, as determined by CMS or the additional conditions of participation
State. not examined during the standard sur-
vey.
§ 488.710 Standard surveys. (b) Timing and basis for survey. An ex-
(a) For each HHA, the survey agency tended survey must be conducted not
must conduct a standard survey not later than 14 calendar days after com-
later than 36 months after the date of pletion of a standard survey which
the previous standard survey that in- found that a HHA was out of compli-
cludes, but is not limited to, all of the ance with a condition of participation.
following (to the extent practicable):
(1) A case-mix stratified sample of in- § 488.725 Unannounced surveys.
dividuals furnished items or services by (a) Basic rule. All HHA surveys must
the HHA. be unannounced and conducted with
(2) Visits to the homes of patients, procedures and scheduling that renders
(the purpose of the home visit is to the onsite surveys as unpredictable in
evaluate the extent to which the qual- their timing as possible.
ity and scope of services furnished by (b) State survey agency’s scheduling
the HHA attained and maintained the and surveying procedures. CMS reviews
highest practicable functional capacity each survey agency’s scheduling and
of each patient as reflected in the pa- surveying procedures and practices to
tient’s written plan of care and clinical assure that the survey agency has
records), but only with their consent, taken all reasonable steps to avoid giv-
and, if determined necessary by CMS or ing notice of a survey through the
the survey team, other forms of com- scheduling procedures and conduct of
munication with patients including the surveys.
telephone calls. (c) Civil money penalties. Any indi-
(3) Review of indicators that include vidual who notifies an HHA, or causes
the outcomes of quality care and serv- an HHA to be notified, of the time or
ices furnished by the agency as indi- date on which a standard survey is
cated by medical, nursing, and reha- scheduled to be conducted is subject to
bilitative care. a Federal civil money penalty not to
(4) Review of compliance with a se- exceed $2,000 as adjusted annually
lect number of regulations most re- under 45 CFR part 102.
lated to high-quality patient care. [77 FR 67164, Nov. 8, 2012, as amended at 81
(b) The survey agency’s failure to fol- FR 61563, Sept. 6, 2016]
low the procedures set forth in this sec-
tion will not invalidate otherwise le- § 488.730 Survey frequency and con-
gitimate determinations that defi- tent.
ciencies exist at an HHA. (a) Basic period. Each HHA must be
surveyed not later than 36 months after
§ 488.715 Partial extended surveys. the last day of the previous standard
A partial extended survey is con- survey. Additionally, a survey may be
ducted to determine if standard or con- conducted as frequently as necessary
dition-level deficiencies are present in to—
the conditions of participation not (1) Assure the delivery of quality
fully examined during the standard home health services by determining
survey and there are indications that a whether an HHA complies with the Act
more comprehensive review of condi- and conditions of participation; and
tions of participation would determine (2) Confirm that the HHA has cor-
if a deficient practice exists. rected deficiencies that were pre-
viously cited.
§ 488.720 Extended surveys. (b) Change in HHA information. A
(a) Purpose of survey. The purpose of standard survey or an abbreviated
an extended survey is: standard survey may be conducted
(1) To review and identify the poli- within 2 months of a change, or knowl-
cies and procedures that caused an edge of a change, in any of the fol-
HHA to furnish substandard care. lowing:
563
§ 488.735 42 CFR Ch. IV (10–1–17 Edition)
(1) Ownership; (4) The surveyor has an immediate

(2) Administration; or, family member who is a patient of the
(3) Management of the HHA. HHA to be surveyed.
(c) Complaints. A standard survey, or
abbreviated standard survey— § 488.740 Certification of compliance
or noncompliance.
(1) Must be conducted of an HHA
within 2 months of when a significant Rules to be followed for certification,
number of complaints against the HHA documentation of findings, periodic re-
are reported to CMS, the State, the view of compliance and approval, cer-
State or local agency responsible for tification of noncompliance, and deter-
maintaining a toll-free hotline and in- mining compliance of HHAs are set
vestigative unit, or any other appro- forth, respectively, in §§ 488.12, 488.18,
priate Federal, State, or local agency; 488.20, 488.24, and 488.26 of this part.
or
(2) As otherwise required to deter- § 488.745 Informal Dispute Resolution
mine compliance with the conditions of (IDR).
participation such as the investigation (a) Opportunity to refute survey find-
of a complaint. ings. Upon the provider’s receipt of an
official statement of deficiencies,
§ 488.735 Surveyor qualifications.
HHAs are afforded the option to re-
(a) Minimum qualifications. Surveys quest an informal opportunity to dis-
must be conducted by individuals who pute condition-level survey findings.
meet minimum qualifications pre- (b) Failure to conduct IDR timely. Fail-
scribed by CMS. In addition, before any ure of CMS or the State, as appro-
State or Federal surveyor may serve on priate, to complete IDR shall not delay
an HHA survey team (except as a train- the effective date of any enforcement
ee), he/she must have successfully com- action.
pleted the relevant CMS-sponsored (c) Revised statement of deficiencies as
Basic HHA Surveyor Training Course a result of IDR. If any findings are re-
and any associated course pre- vised or removed by CMS or the State
requisites. All surveyors must follow based on IDR, the official statement of
the principles set forth in § 488.24 deficiencies is revised accordingly and
through § 488.28 according to CMS poli- any enforcement actions imposed sole-
cies and procedures for determining ly as a result of those cited deficiencies
compliance with the conditions of par- are adjusted accordingly.
ticipation.
(d) Notification. When the survey find-
(b) Disqualifications. Any of the fol-
ings indicate a condition-level defi-
lowing circumstances disqualifies a
ciency, CMS or the State, as appro-
surveyor from surveying a particular
priate, must provide the agency with
agency:
written notification of the opportunity
(1) The surveyor currently works for, for participating in an IDR process at
or, within the past two years, has the time the official statement of defi-
worked with the HHA to be surveyed
ciencies is issued. The request for IDR
as:
must be submitted in writing to the
(i) A direct employee; State or CMS, must include the spe-
(ii) An employment agency staff at cific deficiencies that are disputed, and
the agency; or must be made within the same 10 cal-
(iii) An officer, consultant, or agent endar day period that the HHA has for
for the agency to be surveyed con- submitting an acceptable plan of cor-
cerning compliance with conditions of rection.
participation specified in or pursuant
to sections 1861(o) or 1891(a) of the Act.
(2) The surveyor has a financial in- Subpart J—Alternative Sanctions
terest or an ownership interest in the for Home Health Agencies
HHA to be surveyed. With Deficiencies
(3) The surveyor has a family mem-

ber who has a relationship with the SOURCE: 77 FR 67165, Nov. 8, 2012, unless
HHA to be surveyed. otherwise noted.
564
§ 488.800 Statutory basis. governing body must ensure that the

Section 1891(e) through (f) of the Act temporary manager has authority to
authorizes the Secretary to take ac- hire, terminate or reassign staff, obli-
tions to remove and correct defi- gate funds, alter procedures, and man-
ciencies in an HHA through an alter- age the HHA to correct deficiencies
native sanction or termination or both. identified in the HHA’s operation.
Furthermore, this section specifies EFFECTIVE DATE NOTE: At 82 FR 4591, Jan.
that these sanctions are in addition to 13, 2017, § 488.805, the definition of temporary
any others available under State or management was amended by removing
Federal law, and, except for the final ‘‘§§ 484.4 and 484.14(c)’’ and adding in its place
determination of civil money penalties, ‘‘§§ 484.105(b) and 484.115’’, effective July 13,
are imposed prior to the conduct of a 2017. At 82 FR 31729, July 10, 2017, this
hearing. amendment was delayed until Jan. 13, 2018.
§ 488.805 Definitions. § 488.810 General provisions.

As used in this subpart— (a) Purpose of sanctions. The purpose
Directed plan of correction means CMS of sanctions is to ensure prompt com-
or the temporary manager (with CMS/ pliance with program requirements in
SA approval) may direct the HHA to order to protect the health and safety
take specific corrective action to of individuals under the care of an
achieve specific outcomes within spe- HHA.
cific timeframes. (b) Basis for imposition of sanctions.
Immediate jeopardy means a situation When CMS chooses to apply one or
in which the provider’s noncompliance more sanctions specified in § 488.820,
with one or more requirements of par- the sanctions are applied on the basis
ticipation has caused, or is likely to of noncompliance with one or more
cause serious injury, harm, impair- conditions of participation found
ment, or death to a patient(s). through a survey and may be based on
New admission means an individual failure to correct previous deficiency
who becomes a patient or is readmitted findings as evidenced by repeat defi-
to the HHA on or after the effective ciencies.
date of a suspension of payment sanc- (c) Number of sanctions. CMS may
tion. apply one or more sanctions for each
Per instance means a single event of deficiency constituting noncompliance
noncompliance identified and corrected or for all deficiencies constituting non-
through a survey, for which the statute
compliance.
authorizes CMS to impose a sanction.
Plan of correction means a plan devel- (d) Extent of sanctions imposed. When
oped by the HHA and approved by CMS CMS imposes a sanction, the sanction
that is the HHA’s written response to applies to the parent HHA and its re-
survey findings detailing corrective ac- spective branch offices.
tions to cited deficiencies and specifies (e) Plan of correction requirement. Re-
the date by which those deficiencies gardless of which sanction is applied, a
will be corrected. non-compliant HHA must submit a
Repeat deficiency means a condition- plan of correction for approval by CMS.
level citation that is cited on the cur- (f) Notification requirements—(1) No-
rent survey and is substantially the tice. CMS provides written notification
same as or similar to, a finding of a to the HHA of the intent to impose the
standard-level or condition-level defi- sanction.
ciency citation cited on the most re- (2) Date of enforcement action. The no-
cent previous standard survey or on tice periods specified in § 488.825(b) and
any intervening survey since the most § 488.830(b) begin the day after the HHA
recent standard survey. receives the notice.
Temporary management means the (g) Appeals. (1) The provisions of part
temporary appointment by CMS or by 498 of this chapter apply when the HHA
a CMS authorized agent, of a sub- requests a hearing on a determination
stitute manager or administrator based of noncompliance leading to the impo-

upon qualifications described in §§ 484.4 sition of a sanction, including termi-
and 484.14(c) of this chapter. The HHA’s nation of the provider agreement.
565
§ 488.815 42 CFR Ch. IV (10–1–17 Edition)
(2) A pending hearing does not delay diate jeopardy has not been removed by
the effective date of a sanction, includ- the HHA.
ing termination, against an HHA. (3) In addition to a termination, CMS
Sanctions continue to be in effect re- may impose one or more alternative
gardless of the timing of any appeals sanctions, as appropriate.
proceedings. (b) 2-day notice. Except for civil
money penalties, for all sanctions spec-
§ 488.815 Factors to be considered in ified in § 488.820 that are imposed when
selecting sanctions. there is immediate jeopardy, notice
CMS bases its choice of sanction or must be given at least 2 calendar days
sanctions on consideration of one or before the effective date of the enforce-
more factors that include, but are not ment action.
limited to, the following: (c) Transfer of care. An HHA, if its
(a) The extent to which the defi- provider agreement terminated, is re-
ciencies pose immediate jeopardy to sponsible for providing information, as-
patient health and safety. sistance, and arrangements necessary
(b) The nature, incidence, manner, for the proper and safe transfer of pa-
degree, and duration of the deficiencies tients to another local HHA within 30
or noncompliance. days of termination. The State must
(c) The presence of repeat defi- assist the HHA in the safe and orderly
ciencies, the HHA’s overall compliance transfer of care and services for the pa-
history and any history of repeat defi- tients to another local HHA.
ciencies at either the parent or branch
location. § 488.830 Action when deficiencies are
at the condition-level but do not
(d) The extent to which the defi- pose immediate jeopardy.
ciencies are directly related to a fail-
ure to provide quality patient care. (a) Noncompliance. If the HHA is no
(e) The extent to which the HHA is longer in compliance with the condi-
part of a larger organization with per- tions of participation, either because
formance problems. the deficiency or deficiencies substan-
tially limit the provider’s capacity to
(f) An indication of any system-wide
furnish adequate care but do not pose
failure to provide quality care.
immediate jeopardy, have a condition-
§ 488.820 Available sanctions. level deficiency or deficiencies that do
not pose immediate jeopardy, or be-
In addition to termination of the pro- cause the HHA has repeat noncompli-
vider agreement, the following alter- ance that results in a condition-level
native sanctions are available: deficiency based on the HHA’s failure
(a) Civil money penalties. to correct and sustain compliance,
(b) Suspension of payment for all new CMS will:
admissions. (1) Terminate the HHA’s provider
(c) Temporary management of the agreement; or
HHA. (2) Impose one or more alternative
(d) Directed plan of correction, as set sanctions set forth in § 488.820(a)
out at § 488.850. through (f) of this part as an alter-
(e) Directed in-service training, as native to termination, for a period not
set out at § 488.855. to exceed 6 months.
(b) 15-day notice. Except for civil
§ 488.825 Action when deficiencies money penalties, for all sanctions spec-
pose immediate jeopardy.
ified in § 488.820 imposed when there is
(a) Immediate jeopardy. If there is im- no immediate jeopardy, notice must be
mediate jeopardy to the HHA’s patient given at least 15 calendar days before
health or safety— the effective date of the enforcement
(1) CMS immediately terminates the action. The requirements of the notice
HHA provider agreement in accordance are set forth in § 488.810(f) of this part.
with § 489.53 of this chapter. (c) Not meeting criteria for continuation
(2) CMS terminates the HHA provider of payment. If an HHA does not meet
agreement no later than 23 days from the criteria for continuation of pay-
the last day of the survey, if the imme- ment under § 488.860(a) of this part,
566
CMS will terminate the HHA’s provider date of the survey identifying non-
agreement in accordance with § 488.865 compliance.
of this part. (d) Payment of salary. (1) The tem-
(d) Termination time frame when there porary manager’s salary—
is no immediate jeopardy. CMS termi- (i) Is paid directly by the HHA while
nates an HHA within 6 months of the the temporary manager is assigned to
last day of the survey, if the HHA is that HHA; and
not in compliance with the conditions (ii) Must be at least equivalent to the
of participation, and the terms of the sum of the following:
plan of correction have not been met. (A) The prevailing salary paid by pro-
(e) Transfer of care. An HHA, if its viders for positions of this type in what
provider agreement terminated, is re- the State considers to be the HHA’s ge-
sponsible for providing information, as- ographic area (prevailing salary based
sistance, and arrangements necessary on the Geographic Guide by the De-
for the proper and safe transfer of pa- partment of Labor (BLS Wage Data by
tients to another local HHA within 30 Area and Occupation);
days of termination. The State must
(B) Any additional costs that would
assist the HHA in the safe and orderly
have reasonably been incurred by the
transfer of care and services for the pa-
HHA if such person had been in an em-
tients to another local HHA.
ployment relationship; and
§ 488.835 Temporary management. (C) Any other costs incurred by such
a person in furnishing services under
(a) Application. (1) CMS may impose
such an arrangement or as otherwise
temporary management of an HHA if it
set by the State.
determines that an HHA has a condi-
(2) An HHA’s failure to pay the salary
tion-level noncompliance and CMS de-
and other costs of the temporary man-
termines that management limitations
ager described in paragraph (d)(1) of
or the deficiencies are likely to impair
this section is considered a failure to
the HHA’s ability to correct defi-
relinquish authority and control to
ciencies and return the HHA to full
temporary management.
compliance with the conditions of par-
ticipation within the timeframe re- § 488.840 Suspension of payment for
quired. all new patient admissions.
(2) [Reserved]
(b) Procedures. (1) CMS notifies the (a) Application. (1) CMS may suspend
HHA that a temporary manager is payment for all new admissions if an
being appointed. HHA is found to have condition-level
(2) If the HHA fails to relinquish au- deficiencies, regardless of whether
thority and control to the temporary those deficiencies pose immediate jeop-
manager, CMS terminates the HHA’s ardy.
provider agreement in accordance with (2) CMS will consider this sanction
§ 488.865. for any deficiency related to poor pa-
(c) Duration and effect of sanction. tient care outcomes, regardless of
Temporary management continues whether the deficiency poses imme-
until— diate jeopardy.
(1) CMS determines that the HHA has (b) Procedures—(1) Notices. (i) Before
achieved substantial compliance and suspending payments for new admis-
has the management capability to en- sions, CMS provides the HHA notice of
sure continued compliance with all the the suspension of payment for all new
conditions of participation; admissions as set forth in § 488.810(f).
(2) CMS terminates the provider The CMS notice of suspension will in-
agreement; or clude the nature of the noncompliance;
(3) The HHA reassumes management the effective date of the sanction; and
control without CMS approval. In such the right to appeal the determination
case, CMS initiates termination of the leading to the sanction.
provider agreement and may impose (ii) The HHA may not charge a newly
additional sanctions. admitted HHA patient who is a Medi-

(4) Temporary management will not care beneficiary for services for which
exceed a period of 6 months from the Medicare payment is suspended unless
567
§ 488.845 42 CFR Ch. IV (10–1–17 Edition)
the HHA can show that, before initi- (iii) Accurate and credible resources,
ating care, it gave the patient or his or such as PECOS, Medicare cost reports
her representative oral and written no- and Medicare/Medicaid claims informa-
tice of the suspension of Medicare pay- tion that provide information on the
ment in a language and manner that operation and resources of the HHA.
the beneficiary or representative can (iv) Evidence that the HHA has a
understand. built-in, self-regulating quality assess-
(2) Restriction. (i) Suspension of payment and performance improvement
ment for all new admissions sanction system to provide proper care, prevent
may be imposed anytime an HHA is poor outcomes, control patient injury,
found to be out of substantial compli- enhance quality, promote safety, and
ance. avoid risks to patients on a sustainable
(ii) Suspension of payment for pa- basis that indicates the ability to meet
tients with new admissions will remain the conditions of participation and to
in place until CMS determines that the ensure patient health and safety.
HHA has achieved substantial compli- (2) Adjustments to penalties. Based on
ance or is involuntarily terminated revisit survey findings, adjustments to
with the conditions of participation, as penalties may be made after a review
determined by CMS. of the provider’s attempted correction
(3) Resumption of payments. Payments of deficiencies.
to the HHA resume prospectively on
(i) CMS may increase a CMP in incre-
the date that CMS determines that the
ments based on a HHA’s inability or
HHA has achieved substantial compli-
failure to correct deficiencies, the pres-
ance with the conditions of participa-
ence of a system-wide failure in the
tion.
provision of quality care, or a deter-
(c) Duration and effect of sanction.
mination of immediate jeopardy with
This sanction ends when—
(1) CMS determines that the HHA is actual harm versus immediate jeop-
in substantial compliance with all of ardy with potential for harm.
the conditions of participation; or (ii) CMS may also decrease a CMP in
(2) When the HHA is terminated or increments to the extent that it finds,
CMS determines that the HHA is not in pursuant to a revisit, that substantial
compliance with the conditions of par- and sustainable improvements have
ticipation at a maximum of 6 months been implemented even though the
from the date noncompliance was de- HHA is not yet in full compliance with
termined. the conditions of participation.
(iii) No penalty assessment will ex-
§ 488.845 Civil money penalties. ceed $10,000 as adjusted annually under
(a) Application. (1) CMS may impose a 45 CFR part 102 for each day of non-
civil money penalty against an HHA compliance.
for either the number of days the HHA (3) Upper range of penalty. Penalties
is not in compliance with one or more in the upper range of $8,500 to $10,000 as
conditions of participation or for each adjusted under 45 CFR part 102 per day
instance that an HHA is not in compli- of noncompliance are imposed for a
ance, regardless of whether the HHA’s condition-level deficiency that is im-
deficiencies pose immediate jeopardy. mediate jeopardy. The penalty in this
(2) CMS may impose a civil money range will continue until compliance
penalty for the number of days of im- can be determined based on a revisit
mediate jeopardy. survey.
(3) A per-day and a per-instance CMP (i) $10,000 as adjusted annually under
may not be imposed simultaneously for 45 CFR part 102 per day for a deficiency
the same deficiency. or deficiencies that are immediate
(b) Amount of penalty—(1) Factors con- jeopardy and that result in actual
sidered. CMS takes into account the harm.
following factors in determining the (ii) $9,000 as adjusted annually under
amount of the penalty: 45 CFR part 102 per day for a deficiency
(i) The factors set out at § 488.815. or deficiencies that are immediate
(ii) The size of an agency and its re- jeopardy and that result in a potential
sources. for harm.
568
(iii) $8,500 as adjusted annually under not corrected and found again at the
45 CFR part 102 per day for an isolated time of revisit survey(s) for which a
incident of noncompliance in violation lower-level penalty amount was pre-
of established HHA policy. viously imposed.
(4) Middle range of penalty. Penalties (iii) CMS may impose a more severe
in the range of $1,500–$8,500 as adjusted amount of penalties for repeated non-
annually under 45 CFR part 102 per day compliance with the same condition-
of noncompliance are imposed for a re- level deficiency or uncorrected defi-
peat and/or condition-level deficiency ciencies from a prior survey.
that does not constitute immediate (c) Procedures—(1) Notice of intent.
jeopardy, but is directly related to poor CMS provides the HHA with written
quality patient care outcomes. notice of the intent to impose a civil
(5) Lower range of penalty. Penalties money penalty. The notice includes the
in this range of $500–$4,000 as adjusted amount of the CMP being imposed, the
annually under 45 CFR part 102 are im- basis for such imposition and the pro-
posed for a repeat and/or condition- posed effective date of the sanction.
level deficiency that does not con- (2) Appeals. (i) Appeals procedures. An
stitute immediate jeopardy and that HHA may request a hearing on the de-
are related predominately to structure termination of the noncompliance that
or process-oriented conditions (such as is the basis for imposition of the civil
OASIS submission requirements) rath-
money penalty. The request must meet
er than directly related to patient care
the requirements in § 498.40 of this
outcomes.
chapter.
(6) Per instance penalty. Penalty im-
posed per instance of noncompliance (ii) Waiver of a hearing. An HHA may
may be assessed for one or more sin- waive the right to a hearing, in writ-
gular events of condition-level non- ing, within 60 days from the date of the
compliance that are identified and notice imposing the civil money pen-
where the noncompliance was cor- alty. If an HHA timely waives its right
rected during the onsite survey. When to a hearing, CMS reduces the penalty
penalties are imposed for per instance amount by 35 percent, and the amount
of noncompliance, or more than one is due within 15 days of the HHAs
per instance of noncompliance, the agreeing in writing to waive the hear-
penalties will be in the range of $1,000 ing. If the HHA does not waive its right
to $10,000 as adjusted annually under 45 to a hearing in accordance to the pro-
CFR part 102 per instance, not to ex- cedures specified in this subsection, the
ceed $10,000 as adjusted annually under civil money penalty is not reduced by
45 CFR part 102 each day of noncompli- 35 percent.
ance. (d) Accrual and duration of penalty.
(7) Decreased penalty amounts. If the (1)(i) The per day civil money penalty
immediate jeopardy situation is re- may start accruing as early as the be-
moved, but condition-level noncompli- ginning of the last day of the survey
ance continues, CMS will shift the pen- that determines that the HHA was out
alty amount imposed per day from the of compliance, as determined by CMS.
upper range to the middle or lower (ii) A civil money penalty for each
range. An earnest effort to correct any per instance of noncompliance is im-
systemic causes of deficiencies and sus- posed in a specific amount for that par-
tain improvement must be evident. ticular deficiency, with a maximum of
(8) Increased penalty amounts. (i) In $10,000 as adjusted annually under 45
accordance with paragraph (b)(2) of CFR part 102 per day per HHA.
this section, CMS will increase the per (2) A penalty that is imposed per day
day penalty amount for any condition- and per instance of noncompliance may
level deficiency or deficiencies which, not be imposed simultaneously.
after imposition of a lower-level pen- (3) Duration of per day penalty when
alty amount, become sufficiently seri- there is immediate jeopardy. (i) In the
ous to pose potential harm or imme- case of noncompliance that poses im-
diate jeopardy. mediate jeopardy, CMS must terminate

(ii) CMS increases the per day pen- the provider agreement within 23 cal-
alty amount for deficiencies that are endar days after the last day of the
569
§ 488.845 42 CFR Ch. IV (10–1–17 Edition)
survey if the immediate jeopardy is not (3) In the case of an HHA for which
removed. the provider agreement has been invol-
(ii) A penalty imposed per day of non- untarily terminated and for which a
compliance will stop accruing on the civil money penalty was imposed on a
day the provider agreement is termi- per day basis, CMS sends this penalty
nated or the HHA achieves substantial information after one of the following
compliance, whichever occurs first. actions has occurred:
(4) Duration of penalty when there is (i) Final administrative decision is
no immediate jeopardy. (i) In the case of made.
noncompliance that does not pose im- (ii) The HHA has waived its right to
mediate jeopardy, the daily accrual of a hearing in accordance with paragraph
per day civil money penalties is im- (c)(2)(ii) of this section.
posed for the days of noncompliance (iii) Time for requesting a hearing
prior to the notice specified in para- has expired and CMS has not received a
graph (c)(1) of this section and an addi- hearing request from the HHA.
tional period of no longer than 6 (f) Due date for payment of penalty. A
months following the last day of the penalty is due and payable 15 days from
survey. notice of the final administrative deci-
(ii) If the HHA has not achieved com- sion.
pliance with the conditions of partici- (1) Payments are due for all civil
pation, CMS terminates the provider money penalties within 15 days:
agreement. The accrual of civil money (i) After a final administrative deci-
penalty stops on the day the HHA sion when the HHA achieves substan-
agreement is terminated or the HHA tial compliance before the final deci-
achieves substantial compliance, sion or the effective date of termi-
whichever is earlier. nation before final decision,
(e) Computation and notice of total pen- (ii) After the time to appeal has ex-
alty amount. (1) When a civil money pired and the HHA does not appeal or
penalty is imposed on a per day basis fails to timely appeal the initial deter-
and the HHA achieves compliance with mination,
the conditions of participation as de- (iii) After CMS receives a written re-
termined by a revisit survey, CMS quest from the HHA requesting to
sends a final notice to the HHA con- waive its right to appeal the deter-
taining all of the following informa- minations that led to the imposition of
tion: a sanction,
(i) The amount of penalty assessed (iv) After substantial compliance is
per day. achieved, or
(ii) The total number of days of non- (v) After the effective date of termi-
compliance. nation.
(iii) The total amount due. (2) A request for hearing does not
(iv) The due date of the penalty. delay the imposition of any penalty; it
(v) The rate of interest to be assessed only potentially delays the collection
on any unpaid balance beginning on of the final penalty amount.
the due date, as provided in paragraph (3) If an HHA waives its right to a
(f)(4) of this section. hearing according to paragraph
(2) When a civil money penalty is im- (c)(2)(ii) of this section, CMS will apply
posed for per instance of noncompli- a 35 percent reduction to the CMP
ance, CMS sends a notice to the HHA amount when:
containing all of the following infor- (i) The HHA achieved compliance
mation: with the conditions of participation be-
(i) The amount of the penalty that fore CMS received the written waiver
was assessed. of hearing; or
(ii) The total amount due. (ii) The effective date of termination
(iii) The due date of the penalty. occurs before CMS received the written
(iv) The rate of interest to be as- waiver of hearing.
sessed on any unpaid balance beginning (4) The period of noncompliance may
on the due date, as provided in para- not extend beyond 6 months from the
graph (f)(6) of this section. last day of the survey.
570
(5) The amount of the penalty, when those specified in paragraph (b) of this
determined, may be deducted (offset) section.
from any sum then or later owing by [77 FR 67165, Nov. 8, 2012, as amended at 79
CMS or State Medicaid to the HHA. FR 66118, Nov. 6, 2014; 81 FR 61563, Sept. 6,
(6) Interest is assessed and accrues on 2016]
the unpaid balance of a penalty, begin-
ning on the due date. Interest is com- § 488.850 Directed plan of correction.
puted at the rate specified in § 405.378(d) (a) Application. CMS may impose a di-
of this chapter. rected plan of correction when an HHA:
(g) Penalties collected by CMS—(1) Dis- (1) Has one or more deficiencies that
bursement of CMPs. Civil money pen- warrant directing the HHA to take spe-
alties and any corresponding interest cific actions; or
collected by CMS from Medicare and (2) Fails to submit an acceptable plan
Medicaid participating HHAs are dis- of correction.
bursed in proportion to average dollars (b) Procedures. (1) Before imposing
spent by Medicare and Medicaid at the this sanction, CMS provides the HHA
national level based on MSIS and HHA notice of the impending sanction.
PPS data for a three year fiscal period. (2) CMS or the temporary manager
(i) Based on expenditures for the FY (with CMS approval) may direct the
2007–2009 period, the initial proportions HHA to take corrective action to
to be disbursed are 63 percent returned achieve specific outcomes within spe-
to the U.S. Treasury and 37 percent re- cific timeframes.
turned to the State Medicaid agency. (c) Duration and effect of sanction. If
(ii) Beginning one year after the ef- the HHA fails to achieve compliance
fective date of this section, CMS shall with the conditions of participation
annually update these proportions within the timeframes specified in the
based on the most recent 3-year fiscal directed plan of correction, CMS:
period, prior to the year in which the (1) May impose one or more other
CMP is imposed, for which CMS deter- sanctions set forth in § 488.820; or
mines that the relevant data are essen- (2) Terminates the provider agree-
tially complete. ment.
(iii) The portion corresponding to the
Medicare payments is returned to the § 488.855 Directed in-service training.
U.S. Department of Treasury as mis- (a) Application. CMS may require the
cellaneous receipts. staff of an HHA to attend in-service
(iv) The portion corresponding to the training program(s) if CMS determines
Medicaid payments is returned to the that—
State Medicaid agency. (1) The HHA has deficiencies that in-
(2) Penalties may not be used for Sur- dicate noncompliance;
vey and Certification operations nor as (2) Education is likely to correct the
the State’s Medicaid non-Federal med- deficiencies; and
ical assistance or administrative (3) The programs are conducted by
match. established centers of health education
(h) Review of the penalty. When an ad- and training or consultants with back-
ministrative law judge or state hearing ground in education and training with
officer (or higher administrative re- Medicare Home Health Providers, or as
view authority) finds that the basis for deemed acceptable by CMS and/or the
imposing a civil monetary penalty ex- State (by review of a copy of cur-
ists, as specified in this part, the ad- riculum vitas and/or resumes/ref-
ministrative law judge, State hearing erences to determine the educator’s
officer (or higher administrative re- qualifications).
view authority) may not— (b) Procedures—(1) Action following
(1) Set a penalty of zero or reduce a training. After the HHA staff has re-
penalty to zero; ceived in-service training, if the HHA
(2) Review the exercise of discretion has not achieved compliance, CMS may
by CMS to impose a civil monetary impose one or more other sanctions
penalty; and specified in § 488.820.

(3) Consider any factors in reviewing (2) Payment. The HHA pays for the di-
the amount of the penalty other than rected in-service training for its staff.
571
§ 488.860 42 CFR Ch. IV (10–1–17 Edition)
§ 488.860 Continuation of payments to under any one of the following condi-

an HHA with deficiencies. tions—
(a) Continued payments. CMS may (1) The HHA is not in compliance
continue payments to an HHA with with the conditions of participation.
condition-level deficiencies that do not (2) The HHA fails to submit an ac-
constitute immediate jeopardy for up ceptable plan of correction within the
to 6 months from the last day of the timeframe specified by CMS.
(3) The HHA fails to relinquish con-
survey if the criteria in paragraph
trol to the temporary manager, if that
(a)(1) of this section are met.
sanction is imposed by CMS.
(1) Criteria. CMS may continue pay-
(4) The HHA fails to meet the eligi-
ments to an HHA not in compliance
bility criteria for continuation of pay-
with the conditions of participation for
ment as set forth in § 488.860(a)(1).
the period specified in paragraph (a) of (c) Notice. CMS notifies the HHA and
this section if all of the following cri- the public of the termination, in ac-
teria are met: cordance with procedures set forth in
(i) The HHA has been imposed an al- § 489.53 of this chapter.
ternative sanction or sanctions and (d) Procedures for termination. CMS
termination has not been imposed. terminates the provider agreement in
(ii) The HHA has submitted a plan of accordance with procedures set forth in
correction approved by CMS. § 489.53 of this chapter.
(iii) The HHA agrees to repay the (e) Appeal. An HHA may appeal the
Federal government payments received termination of its provider agreement
under this provision if corrective ac- by CMS in accordance with part 498 of
tion is not taken in accordance with this chapter.
the approved plan and timetable for
corrective action.
(2) CMS may terminate the HHA’s PART 489—PROVIDER AGREEMENTS
provider agreement any time if the cri-
teria in paragraph (a)(1) of this section
AND SUPPLIER APPROVAL
are not met. Subpart A—General Provisions
(b) Cessation of payments for new ad-
missions. If termination is imposed, ei- Sec.
ther on its own or in addition to an al- 489.1 Statutory basis.
ternative sanction or sanctions, or if 489.2 Scope of part.
489.3 Definitions.
any of the criteria set forth in para- 489.10 Basic requirements.
graph (a)(1) of this section are not met, 489.11 Acceptance of a provider as a partici-
the HHA will receive no Medicare pay- pant.
ments, as applicable, for new admis- 489.12 Decision to deny an agreement.
sions following the last day of the sur- 489.13 Effective date of agreement or ap-
vey. proval.
(c) Failure to achieve compliance with 489.18 Change of ownership or leasing: Ef-
fect on provider agreement.
the conditions of participation. If the
HHA does not achieve compliance with Subpart B—Essentials of Provider
the conditions of participation by the Agreements
end of the period specified in paragraph
(a) of this section, CMS will terminate 489.20 Basic commitments.
the provider agreement of the HHA in 489.21 Specific limitations on charges.
accordance with § 488.865. 489.22 Special provisions applicable to pre-
payment requirements.
489.23 Specific limitation on charges for
§ 488.865 Termination of provider
services provided to certain enrollees of
agreement.
fee-for-service FEHB plans.
(a) Effect of termination by CMS. Ter- 489.24 Special responsibilities of Medicare
mination of the provider agreement hospitals in emergency cases.
ends— 489.25 Special requirements concerning
CHAMPUS and CHAMPVA programs.
(1) Payment to the HHA; and
489.26 Special requirements concerning vet-

(2) Any alternative sanction(s). erans.
(b) Basis for termination. CMS termi- 489.27 Beneficiary notice of discharge
nates an HHA’s provider agreement rights.
572
489.28 Special capitalization requirements Subpart I—Advance Directives
for HHAs.
489.29 Special requirements concerning 489.100 Definition.
beneficiaries served by the Indian Health 489.102 Requirements for providers.
Service, Tribal health programs, and 489.104 Effective dates.
urban Indian organization health pro- AUTHORITY: Secs. 1102 1819, 1820(E), 1861,
grams. 1864(M), 1866, 1869, and 1871 of the Social Se-
curity Act (42 U.S.C. 1302, 1395i–3, 1395x,
Subpart C—Allowable Charges 1395aa(m), 1395cc, 1395ff, and 1395(hh)).
489.30 Allowable charges: Deductibles and SOURCE: 45 FR 22937, Apr. 4, 1980, unless
coinsurance. otherwise noted.
489.31 Allowable charges: Blood.
489.32 Allowable charges: Noncovered and Subpart A—General Provisions
partially covered services.
489.34 Allowable charges: Hospitals partici- § 489.1 Statutory basis.
pating in State reimbursement control
systems or demonstration projects. (a) This part implements section 1866
489.35 Notice to intermediary. of the Social Security Act (the Act).
Section 1866 of the Act specifies the
Subpart D—Handling of Incorrect terms of provider agreements, the
Collections grounds for terminating a provider
agreement, the circumstances under
489.40 Definition of incorrect collection.
which payment for new admissions
489.41 Timing and methods of handling.
489.42 Payment of offset amounts to bene-
may be denied, and the circumstances
ficiary or other person. under which payment may be withheld
for failure to make timely utilization
Subpart E—Termination of Agreement and review. The sections of the Act speci-
Reinstatement After Termination fied in paragraphs (a)(1) through (a)(4)
of this section are also pertinent.
489.52 Termination by the provider. (1) Section 1861 of the Act defines the
489.53 Termination by CMS. services covered under Medicare and
489.54 Termination by the OIG. the providers that may be reimbursed
489.55 Exceptions to effective date of termi-
for furnishing those services.
nation.
489.57 Reinstatement after termination.
(2) Section 1864 of the Act provides
for the use of State survey agencies to
Subpart F—Surety Bond Requirements for ascertain whether certain entities
HHAs meet the conditions of participation.
(3) Section 1865(a)(1) of the Act pro-
489.60 Definitions. vides that an entity accredited by a na-
489.61 Basic requirement for surety bonds. tional accreditation body found by the
489.62 Requirement waived for Government- Secretary to satisfy the Medicare con-
operated HHAs. ditions of participation, conditions for
489.63 Parties to the bond.
coverage, or conditions of certification
489.64 Authorized Surety and exclusion of
surety companies.
or requirements for participation shall
489.65 Amount of the bond. be treated as meeting those require-
489.66 Additional requirements of the surety ments. Section 1865(a)(2) of the Act re-
bond. quires the Secretary to consider when
489.67 Term and type of bond. making such a finding, among other
489.68 Effect of failure to obtain, maintain, things, the national accreditation
and timely file a surety bond. body’s accreditation requirements and
489.69 Evidence of compliance. survey procedures.
489.70 Effect of payment by the Surety. (4) Section 1871 of the Act authorizes
489.71 Surety’s standing to appeal Medicare the Secretary to prescribe regulations
determinations.
for the administration of the Medicare
489.72 Effect of review reversing CMS’s de-
termination.
program.
489.73 Effect of conditions of payment. (b) Although section 1866 of the Act
489.74 Incorporation into existing provider speaks only to providers and provider
agreements. agreements, the following rules in this

part also apply to the approval of sup-
Subparts G–H [Reserved] plier entities that, for participation in
573
§ 489.2 42 CFR Ch. IV (10–1–17 Edition)
Medicare, are subject to a determina- (9) Religious nonmedical health care

tion by CMS on the basis of a survey institutions (RNHCIs).
conducted by the SA or CMS surveyors; (c)(1) Clinics, rehabilitation agencies,
or, in lieu of an SA or CMS-conducted and public health agencies may enter
survey, accreditation by an accrediting into provider agreements only for fur-
organization whose program has CMS nishing outpatient physical therapy,
approval in accordance with the re- and speech pathology services.
quirements of part 488 of this chapter (2) CMHCs may enter into provider
at the time of the accreditation survey agreements only to furnish partial hos-
and accreditation decision, in accord- pitalization services.
ance with the following:
[45 FR 22937, Apr. 4, 1980, as amended at 47
(1) The definition of immediate jeop- FR 56297, Dec. 15, 1982; 48 FR 56036, Dec. 15,
ardy at § 489.3. 1983; 51 FR 24492, July 3, 1986; 58 FR 30676,
(2) The effective date rules specified May 26, 1993; 59 FR 6578, Feb. 11, 1994; 62 FR
in § 489.13. 46037, Aug. 29, 1997; 68 FR 66720, Nov. 28, 2003]
(3) The requirements specified in
§ 489.53(a)(2), (13), and (18), related to § 489.3 Definitions.
termination by CMS of participation in For purposes of this part—
Medicare. Immediate jeopardy means a situation
(c) Section 1861(o)(7) of the Act rein which the provider’s or supplier’s
quires each HHA to provide CMS with non-compliance with one or more re-
a surety bond. quirements, conditions of participa-
[75 FR 50418, Aug. 16, 2010, as amended at 80 tion, conditions for coverage, or condi-
FR 29839, May 22, 2015] tions for certification has caused, or is
likely to cause, serious injury, harm,
§ 489.2 Scope of part. impairment, or death to a resident or
(a) Subpart A of this part sets forth patient.
the basic requirements for submittal Physician-owned hospital means any
and acceptance of a provider agree- participating hospital (as defined in
ment under Medicare. Subpart B of this § 489.24) in which a physician, or an im-
part specifies the basic commitments mediate family member of a physician
and limitations that the provider must (as defined in § 411.351 of this chapter),
agree to as part of an agreement to has an ownership or investment inter-
provide services. Subpart C specifies est in the hospital. The ownership or
the limitations on allowable charges to investment interest may be through
beneficiaries for deductibles, coinsur- equity, debt, or other means, and in-
ance, copayments, blood, and services cludes an interest in an entity that
that must be part of the provider holds an ownership or investment in-
agreement. Subpart D of this part terest in the hospital. This definition
specifies how incorrect collections are does not include a hospital with physi-
to be handled. Subpart F sets forth the cian ownership or investment interests
circumstances and procedures for de- that satisfy the requirements at
nial of payments for new admissions § 411.356(a) or (b) of this chapter.
and for withholding of payment as an Provider agreement means an agree-
alternative to termination of a pro- ment between CMS and one of the pro-
vider agreement. viders specified in § 489.2(b) to provide
(b) The following providers are sub- services to Medicare beneficiaries and
ject to the provisions of this part: to comply with the requirements of
(1) Hospitals. section 1866 of the Act.
(2) Skilled nursing facilities (SNFs). [48 FR 39837, Sept. 1, 1983, as amended at 51
(3) Home health agencies (HHAs). FR 24492, July 3, 1986; 54 FR 5373, Feb. 2, 1989;
(4) Clinics, rehabilitation agencies, 59 FR 56250, Nov. 10, 1994; 60 FR 50119, Sept.
and public health agencies. 28, 1995; 72 FR 47412, Aug. 22, 2007; 73 FR 48757,
(5) Comprehensive outpatient reha- Aug. 19, 2008; 80 FR 29840, May 22, 2015]
bilitation facilities (CORFs).
(6) Hospices. § 489.10 Basic requirements.
(7) Critical access hospital (CAHs). (a) Any of the providers specified in
(8) Community mental health centers § 489.2 may request participation in
(CMHCs). Medicare. In order to be accepted, it
574
must meet the conditions of participa- surety bond requirements specified in

tion or requirements (for SNFs) set subpart F of this part.
forth in this section and elsewhere in (f) In order for a home health agency
this chapter. The RNHCIs must meet to be accepted as a new provider, it
the conditions for coverage, conditions must also meet the capitalization re-
for participation and the requirements quirements specified in subpart B of
set forth in this section and elsewhere this part.
in this chapter. [58 FR 61843, Nov. 23, 1993, as amended at 59
(b) In order to participate in the FR 6578, Feb. 11, 1994; 63 FR 312, Jan. 5, 1998;
Medicare program, the provider must 68 FR 66720, Nov. 28, 2003]
meet the applicable civil rights re-
quirements of: § 489.11 Acceptance of a provider as a
participant.
(1) Title VI of the Civil Rights Act of
1964, as implemented by 45 CFR part 80, (a) Action by CMS. If CMS determines
which provides that no person in the that the provider meets the require-
United States shall, on the ground of ments, it will send the provider—
race, color, or national origin, be ex- (1) Written notice of that determina-
cluded from participation in, be denied tion; and
the benefits of, or be subject to dis- (2) Two copies of the provider agree-
crimination under, any program or ac- ment.
tivity receiving Federal financial as- (b) Action by provider. If the provider
sistance (section 601); wishes to participate, it must return
both copies of the agreement, duly
(2) Section 504 of the Rehabilitation
signed by an authorized official, to
Act of 1973, as implemented by 45 CFR
CMS, together with a written state-
part 84, which provides that no quali-
ment indicating whether it has been
fied handicapped person shall, on the
adjudged insolvent or bankrupt in any
basis of handicap, be excluded from
State or Federal court, or whether any
participation in, be denied the benefits insolvency or bankruptcy actions are
of, or otherwise be subject to discrimi- pending.
nation under any program or activity (c) Notice of acceptance. If CMS ac-
receiving Federal financial assistance; cepts the agreement, it will return one
(3) The Age Discrimination Act of copy to the provider with a written no-
1975, as implemented by 45 CFR part 90, tice that—
which is designed to prohibit discrimi- (1) Indicates the dates on which it
nation on the basis of age in programs was signed by the provider’s represent-
or activities receiving Federal finan- ative and accepted by CMS; and
cial assistance. The Age Discrimina- (2) Specifies the effective date of the
tion Act also permits federally assisted agreement.
programs and activities, and bene-
ficiaries of Federal funds, to continue [45 FR 22937, Apr. 4, 1980, as amended at 59
FR 56251, Nov. 10, 1994; 62 FR 43937, Aug. 18,
to use certain age distinctions, and fac-
1997]
tors other than age, that meet the re-
quirements of the Age Discrimination § 489.12 Decision to deny an agree-
Act and 45 CFR part 90; and ment.
(4) Other pertinent requirements of (a) Bases for denial. CMS may refuse
the Office of Civil Rights of HHS. to enter into an agreement for any of
(c) In order for a hospital, SNF, HHA, the following reasons:
hospice, or RNHCI to be accepted, it (1) Principals of the prospective pro-
must also meet the advance directives vider have been convicted of fraud (see
requirements specified in subpart I of § 420.204 of this chapter);
this part. (2) The prospective provider has
(d) The State survey agency will as- failed to disclose ownership and control
certain whether the provider meets the interests in accordance with § 420.206 of
conditions of participation or require- this chapter;
ments (for SNFs) and make its rec- (3) The prospective provider is a phy-
ommendations to CMS. sician-owned hospital as defined in

(e) In order for a home health agency § 489.3 and does not have procedures in
to be accepted, it must also meet the place for making physician ownership
575
§ 489.13 42 CFR Ch. IV (10–1–17 Edition)
disclosures to patients in accordance the accreditation decision, as applica-

with § 489.20(u); or ble, if on that date the provider or sup-
(4) The prospective provider is unable plier meets all applicable Federal re-
to give satisfactory assurance of com- quirements as set forth in this chapter.
pliance with the requirements of title (If the agreement or approval is time-
XVIII of the Act. limited, the new agreement or approval
(b) [Reserved] is effective on the day following the ex-
(c) Compliance with civil rights require- piration of the current agreement or
ments. CMS will not enter into a pro- approval.) However, the effective date
vider agreement if the provider fails to of the agreement or approval may not
comply with civil rights requirements be earlier than the latest of the dates
set forth in 45 CFR parts 80, 84, and 90, on which CMS determines that each
subject to the provisions of § 489.10. applicable Federal requirement is met.
[45 FR 22937, Apr. 4, 1980, as amended at 51 Federal requirements include, but are
FR 34833, Sept. 30, 1986; 54 FR 4027, Jan. 27, not limited to—
1989; 59 FR 6578, Feb. 11, 1994; 59 FR 56251, (1) Enrollment requirements estab-
Nov. 10, 1994; 72 FR 47413, Aug. 22, 2007]
lished in part 424, subpart P, of this
§ 489.13 Effective date of agreement or chapter. CMS determines, based upon
approval. its review and verification of the pro-
(a) Applicability—(1) General rule. Ex- spective provider’s or supplier’s enroll-
cept as provided in paragraph (a)(2) of ment application, the date on which
this section, this section applies to enrollment requirements have been
Medicare provider agreements with, met;
and supplier approval of, entities that, (2) The requirements identified in
as a basis for participation in Medicare §§ 489.10 and 489.12; and
are subject to a determination by CMS (3) The applicable Medicare health
on the basis of— and safety standards, such as the appli-
(i) A survey conducted by the State cable conditions of participation, the
survey agency or CMS surveyors; or requirements for participation, the
(ii) In lieu of such State survey agen- conditions for coverage, or the condi-
cy or CMS conducted survey, accredita- tions for certification.
tion by an accreditation organization (c) All health and safety standards are
whose program has CMS approval in not met on the date of survey. If, on the
accordance with section 1865 of the Act date the survey is completed, the pro-
at the time of the accreditation survey vider or supplier has failed to meet any
and accreditation decision. one of the applicable health and safety
(2) Exceptions. (i) For an agreement standards, the following rules apply for
with a community mental health cen- determining the effective date of the
ter (CMHC) or a federally qualified
provider agreement or supplier ap-
health center (FQHC), the effective
proval, assuming that no other Federal
date is the date on which CMS accepts
requirements remain to be satisfied.
a signed agreement which assures that
However, if other Federal requirements
the CMHC or FQHC meets all Federal
remain to be satisfied, notwithstanding
requirements.
(ii) A Medicare supplier approval of a the provisions of paragraphs (c)(1)
laboratory is effective only while the through (c)(3) of this section, the effec-
laboratory has in effect a valid CLIA tive date of the agreement or approval
certificate issued under part 493 of this may not be earlier than the latest of
chapter, and only for the specialty and the dates on which CMS determines
subspecialty tests it is authorized to that each applicable Federal require-
perform. ment is met.
(b) All health and safety standards are (1) For an agreement with an SNF,
met on the date of survey. The agree- the effective date is the date on
ment or approval is effective on the which—
date the State agency, CMS, or the (i) The SNF is in substantial compli-
CMS contractor survey (including the ance (as defined in § 488.301 of this chap-
Life Safety Code survey, if applicable) ter) with the requirements for partici-
is completed, or on the effective date of pation; and
576
(ii) CMS or the State survey agency § 489.18 Change of ownership or leas-
receives from the SNF, if applicable, an ing: Effect on provider agreement.
approvable waiver request. (a) What constitutes change of owner-
(2) For an agreement with, or an ap- ship—(1) Partnership. In the case of a
proval of, any other provider or sup- partnership, the removal, addition, or
plier, (except those specified in para- substitution of a partner, unless the
graph (a)(2) of this section), the effec- partners expressly agree otherwise, as
tive date is the earlier of the following: permitted by applicable State law, con-
(i) The date on which the provider or stitutes change of ownership.
supplier meets all applicable condi- (2) Unincorporated sole proprietorship.
tions of participation, conditions for Transfer of title and property to an-
coverage, or conditions for certifi- other party constitutes change of own-
cation; or, if applicable, the date of a ership.
CMS-approved accreditation organiza- (3) Corporation. The merger of the
tion program’s positive accreditation provider corporation into another cor-
decision, issued after the accreditation poration, or the consolidation of two or
organization has determined that the more corporations, resulting in the cre-
provider or supplier meets all applica- ation of a new corporation constitutes
change of ownership. Transfer of cor-
ble conditions.
porate stock or the merger of another
(ii) The date on which a provider or
corporation into the provider corpora-
supplier is found to meet all conditions tion does not constitute change of own-
of participation, conditions for cov- ership.
erage, or conditions for certification, (4) Leasing. The lease of all or part of
but has lower-level deficiencies, and— a provider facility constitutes change
(A) CMS or the State survey agency of ownership of the leased portion.
receives an acceptable plan of correc- (b) Notice to CMS. A provider who is
tion for the lower-level deficiencies contemplating or negotiating a change
(the date of receipt is the effective date of ownership must notify CMS.
regardless of when the plan of correc- (c) Assignment of agreement. When
tion is approved); or, if applicable, a there is a change of ownership as speci-
CMS-approved accreditation organiza- fied in paragraph (a) of this section,
tion program issues a positive accredi- the existing provider agreement will
tation decision after it receives an ac- automatically be assigned to the new
ceptable plan of correction for the owner.
lower-level deficiencies; or (d) Conditions that apply to assigned
(B) CMS receives an approvable waiv- agreements. An assigned agreement is
er request (the date of receipt is the ef- subject to all applicable statutes and
fective date regardless of when CMS regulations and to the terms and condi-
approves the waiver request). tions under which it was originally
issued including, but not limited to,
(3) For an agreement with any other
the following:
provider or an approval of any other
(1) Any existing plan of correction.
supplier (except those specified in para-
(2) Compliance with applicable health
graph (a)(2) of this section) that is
and safety standards.
found to meet all conditions of partici- (3) Compliance with the ownership
pation, conditions for coverage, or con- and financial interest disclosure re-
ditions for certification, but has lower- quirements of part 420, subpart C, of
level deficiencies and has submitted this chapter.
both an approvable plan of correction/ (4) Compliance with civil rights re-
positive accreditation decision and an quirements set forth in 45 CFR parts 80,
approvable waiver request, the effec- 84, and 90.
tive date is the later of the dates that (e) Effect of leasing. The provider
result when calculated in accordance agreement will be assigned to the les-
with paragraph (c)(2)(ii)(A) or see only to the extent of the leased por-
(c)(2)(ii)(B) of this section. tion of the facility.

[75 FR 50418, Aug. 16, 2010] [45 FR 22937, Apr. 4, 1980, as amended at 59
FR 56251, Nov. 10, 1994]
577
§ 489.20 42 CFR Ch. IV (10–1–17 Edition)
Subpart B—Essentials of Provider QIO that has a contract with CMS

Agreements under part B of title XI of the Act.
(f) To maintain a system that, during
§ 489.20 Basic commitments. the admission process, identifies any
The provider agrees to the following: primary payers other than Medicare, so
(a) To limit its charges to bene- that incorrect billing and Medicare
ficiaries and to other individuals on overpayments can be prevented.
their behalf, in accordance with provi- (g) To bill other primary payers be-
sions of subpart C of this part. fore Medicare.
(b) To comply with the requirements (h) If the provider receives payment
of subpart D of this part for the return for the same services from Medicare
or other disposition of any amounts in- and another payer that is primary to
correctly collected from a beneficiary Medicare, to reimburse Medicare any
or any other person in his or her be- overpaid amount within 60 days.
half. (i) If the provider receives, from a
(c) To comply with the requirements payer that is primary to Medicare, a
of § 420.203 of this chapter when it hires payment that is reduced because the
certain former employees of inter- provider failed to file a proper claim—
mediaries. (1) To bill Medicare for an amount no
(d) In the case of a hospital or a CAH greater than would have been payable
that furnishes services to Medicare as secondary payment if the primary
beneficiaries, either to furnish directly insurer’s payment had been based on a
or to make arrangements (as defined in proper claim; and
§ 409.3 of this chapter) for all Medicare- (2) To charge the beneficiary only: (i)
covered services to inpatients and out- The amount it would have been enti-
patients of a hospital or a CAH except tled to charge if it had filed a proper
the following: claim and received payment based on
(1) Physicians’ services that meet the such a claim; and
criteria of § 415.102(a) of this chapter for (ii) An amount equal to any primary
payment on a reasonable charge basis. payment reduction attributable to fail-
(2) Physician assistant services, as ure to file a proper claim, but only if
defined in section 1861(s)(2)(K)(i) of the the provider can show that—
Act, that are furnished after December (A) It failed to file a proper claim
31, 1990. solely because the beneficiary, for any
(3) Nurse practitioner and clinical reason other than mental or physical
nurse specialist services, as defined in incapacity, failed to give the provider
section 1861(s)(2)(K)(ii) of the Act. the necessary information; or
(4) Certified nurse-midwife services, (B) The beneficiary, who was respon-
as defined in section 1861(ff) of the Act, sible for filing a proper claim, failed to
that are furnished after December 31, do so for any reason other than mental
1990. or physical incapacity.
(5) Qualified psychologist services, as (j) In the State of Oregon, because of
defined in section 1861(ii) of the Act, a court decision, and in the absence of
that are furnished after December 31, a reversal on appeal or a statutory
1990. clarification overturning the decision,
(6) Services of an anesthetist, as de- hospitals may bill liability insurers
fined in § 410.69 of this chapter. first. However, if the liability insurer
(e) In the case of a hospital or CAH does not pay ‘‘promptly’’, as defined in
that furnishes inpatient hospital serv- § 411.50 of this chapter, the hospital
ices or inpatient CAH services for must withdraw its claim or lien and
which payment may be made under bill Medicare for covered services.
Medicare, to maintain an agreement (k) In the case of home health agen-
with a QIO for that organization to re- cies that provide home health services
view the admissions, quality, appro- to Medicare beneficiaries under sub-
priateness, and diagnostic information part E of part 409 and subpart C f part
related to those inpatient services. The 410 of this chapter, to offer to furnish
requirement of this paragraph (e) ap- catheters, catheter supplies, ostomy

plies only if, for the area in which the bags, and supplies related to ostomy
hospital or CAH is located, there is a care to any individual who requires
578
them as part of their furnishing of (2) An on-call list of physicians who

home health services. are on the hospital’s medical staff or
(l) In the case of a hospital as defined who have privileges at the hospital, or
in § 489.24(b) to comply with § 489.24. who are on the staff or have privileges
(m) In the case of a hospital as de- at another hospital participating in a
fined in § 489.24(b), to report to CMS or formal community call plan, in accord-
the State survey agency any time it ance with § 489.24(j)(2)(iii), available to
has reason to believe it may have re- provide treatment necessary after the
ceived an individual who has been initial examination to stabilize indi-
transferred in an unstable emergency viduals with emergency medical condi-
medical condition from another hos- tions who are receiving services re-
pital in violation of the requirements quired under § 489.24 in accordance with
of § 489.24(e). the resources available to the hospital;
(n) In the case of inpatient hospital and
services, to participate in any health (3) A central log on each individual
plan contracted for under 10 U.S.C. 1079 who comes to the emergency depart-
or 1086 or 38 U.S.C. 613, in accordance ment, as defined in § 489.24(b), seeking
with § 489.25. assistance and whether he or she re-
(o) In the case of inpatient hospital fused treatment, was refused treat-
services, to admit veterans whose ad- ment, or whether he or she was trans-
mission has been authorized under 38 ferred, admitted and treated, stabilized
U.S.C. 603, in accordance with § 489.26. and transferred, or discharged.
(p) To comply with § 489.27 of this (s) In the case of an SNF, either to
part concerning notification of Medi- furnish directly or make arrangements
care beneficiaries of their rights asso- (as defined in § 409.3 of this chapter) for
ciated with the termination of Medi- all Medicare-covered services furnished
care services. to a resident (as defined in § 411.15(p)(3)
(q) In the case of a hospital as defined of this chapter) of the SNF, except the
in § 489.24(b)— following:
(1) To post conspicuously in any (1) Physicians’ services that meet the
emergency department or in a place or criteria of § 415.102(a) of this chapter for
places likely to be noticed by all indi- payment on a fee schedule basis.
viduals entering the emergency depart- (2) Services performed under a physi-
ment, as well as those individuals wait- cian’s supervision by a physician as-
ing for examination and treatment in sistant who meets the applicable defi-
areas other than traditional emergency
nition in section 1861(aa)(5) of the Act.
departments (that is, entrance, admit-
(3) Services performed by a nurse
ting area, waiting room, treatment
area), a sign (in a form specified by the practitioner or clinical nurse specialist
Secretary) specifying rights of individ- who meets the applicable definition in
uals under Section 1867 of the Act with section 1861(aa)(5) of the Act and is
respect to examination and treatment working in collaboration (as defined in
for emergency medical conditions and section 1861(aa)(6) of the Act) with a
women in labor; and physician.
(2) To post conspicuously (in a form (4) Services performed by a certified
specified by the Secretary) information nurse-midwife, as defined in section
indicating whether or not the hospital 1861(gg) of the Act.
or rural primary care hospital partici- (5) Services performed by a qualified
pates in the Medicaid program under a psychologist, as defined in section
State plan approved under title XIX. 1861(ii) of the Act.
(r) In the case of a hospital as defined (6) Services performed by a certified
in § 489.24(b) (including both the trans- registered nurse anesthetist, as defined
ferring and receiving hospitals), to in section 1861(bb) of the Act.
maintain— (7) Dialysis services and supplies, as
(1) Medical and other records related defined in section 1861(s)(2)(F) of the
to individuals transferred to or from Act, and those ambulance services that

the hospital for a period of 5 years from are furnished in conjunction with
the date of the transfer; them.
579
§ 489.20 42 CFR Ch. IV (10–1–17 Edition)
(8) Erythropoietin (EPO) for dialysis subject to a civil money penalty in ac-
patients, as defined in section cordance with section 17 of the Occupa-
1861(s)(2)(O) of the Act. tional Safety and Health Act of 1970,
(9) Hospice care, as defined in section including any adjustments of the civil
1861(dd) of the Act. money penalty amounts under the Fed-
(10) An ambulance trip that initially eral Civil Penalties Inflation Adjust-
conveys an individual to the SNF to be ment Act, for a violation of the BBP
admitted as a resident, or that conveys standards. A civil money penalty will
an individual from the SNF in connec- be imposed and collected in the same
tion with one of the circumstances manner as civil money penalties under
specified in § 411.15(p)(3)(i) through section 1128A(a) of the Social Security
(p)(3)(iv) of this chapter as ending the Act.
individual’s status as an SNF resident.
(u) Except as provided in paragraph
(11) The transportation costs of elec-
(v) of this section, in the case of a phy-
trocardiogram equipment (HCPCS code
sician-owned hospital as defined at
R0076), but only with respect to those
§ 489.3—
electrocardiogram test services fur-
nished during 1998. (1) To furnish written notice to each
(12) Services described in paragraphs patient at the beginning of the pa-
(s)(1) through (6) of this section when tient’s hospital stay or outpatient visit
furnished via telehealth under section that the hospital is a physician-owned
1834(m)(4)(C)(ii)(VII) of the Act. hospital, in order to assist the patient
(13) Those chemotherapy items iden- in making an informed decision regard-
tified, as of July 1, 1999, by HCPCS ing his or her care, in accordance with
codes J9000–J9020; J9040–J9151; J9170– § 482.13(b)(2) of this subchapter. The no-
J9185; J9200–J9201; J9206–J9208; J9211; tice should disclose, in a manner rea-
J9230–J9245; and J9265–J9600; and, as of sonably designed to be understood by
January 1, 2004, by HCPCS codes A9522, all patients, the fact that the hospital
A9523, A9533, and A9534. meets the Federal definition of a physi-
(14) Those chemotherapy administra- cian-owned hospital specified in § 489.3
tion services identified, as of July 1, and that the list of the hospital’s own-
1999, by HCPCS codes 36260–36262; 36489; ers or investors who are physicians or
36530–36535; 36640; 36823; and 96405–96542. immediate family members (as defined
(15) Those radioisotope services iden- at § 411.351 of this chapter) of physi-
tified, as of July 1, 1999, by HCPCS cians is available upon request and
codes 79030–79440. must be provided to the patient at the
(16) Those customized prosthetic de- time the request for the list is made by
vices (including artificial limbs and or on behalf of the patient. For pur-
their components) identified, as of July poses of this paragraph (u)(1), the hos-
1, 1999, by HCPCS codes L5050–L5340; pital stay or outpatient visit begins
L5500–L5611; L5613–L5986; L5988; L6050– with the provision of a package of in-
L6370; L6400–6880; L6920–L7274; and
formation regarding scheduled
L7362–L7366, which are delivered for a
preadmission testing and registration
resident’s use during a stay in the SNF
for a planned hospital admission for in-
and intended to be used by the resident
patient care or an outpatient service.
after discharge from the SNF.
(17) Those RHC and FQHC services (2) To require each physician who is a
that are described in § 405.2411(b)(2) of member of the hospital’s medical staff
this chapter. to agree, as a condition of continued
(t) Hospitals that are not otherwise medical staff membership or admitting
subject to the Occupational Safety and privileges, to disclose, in writing, to all
Health Act of 1970 (or a State occupa- patients the physician refers to the
tional safety and health plan that is hospital any ownership or investment
approved under section 18(b) of the Oc- interest in the hospital that is held by
cupational Safety and Health Act) the physician or by an immediate fam-
must comply with the bloodborne ily member (as defined at § 411.351 of
pathogens (BBP) standards under 29 this chapter) of the physician. Disclo-

CFR 1910.1030. A hospital that fails to sure must be required at the time the
comply with the BBP standards may be referral is made.
580
(v) The requirements of paragraph (u) medical needs of any patient who de-
of this section do not apply to any phy- velops an emergency medical condi-
sician-owned hospital that does not tion, as defined in § 489.24(b), at a time
have at least one referring physician when there is no doctor of medicine or
(as defined at § 411.351 of this chapter) doctor of osteopathy present in the
who has an ownership or investment hospital.
interest in the hospital or who has an (4) Before admitting a patient or pro-
immediate family member who has an viding an outpatient service to out-
ownership or investment interest in patients for whom a notice is required,
the hospital, provided that such hos- the hospital must receive a signed ac-
pital signs an attestation statement to knowledgment from the patient stating
that effect and maintains such attesta- that the patient understands that a
tion in its records. doctor of medicine or doctor of osteop-
(w)(1) In the case of a hospital as de- athy may not be present during all
fined in § 489.24(b), to furnish written hours services are furnished to the pa-
notice to all patients at the beginning tient.
of their planned or unplanned inpatient (5) Each dedicated emergency depart-
hospital stay or at the beginning of ment, as that term is defined in
any planned or unplanned outpatient § 489.24(b), in a hospital in which a doc-
visit for observation, surgery or any tor of medicine or doctor of osteopathy
other procedure requiring anesthesia, if is not present 24 hours per day, 7 days
a doctor of medicine or a doctor of os- per week must post a notice conspicu-
teopathy is not present in the hospital ously in a place or places likely to be
24 hours per day, 7 days per week, in noticed by all individuals entering the
order to assist the patients in making dedicated emergency department. The
informed decisions regarding their posted notice must state that the hos-
care, in accordance with § 482.13(b)(2) of pital does not have a doctor of medi-
this subchapter. For purposes of this
cine or a doctor of osteopathy present
paragraph, a planned hospital stay or
in the hospital 24 hours per day, 7 days
outpatient visit begins with the provi-
per week, and must indicate how the
sion of a package of information re-
hospital will meet the medical needs of
garding scheduled preadmission testing
any patient with an emergency medical
and registration for a planned hospital
condition, as defined in § 489.24(b), at a
admission for inpatient care or out-
time when there is no doctor of medi-
patient service. An unplanned hospital
cine or doctor of osteopathy present in
stay or outpatient visit begins at the
the hospital.
earliest point at which the patient pre-
sents to the hospital. (x) To comply with § 488.30 of this
(2) In the case of a hospital that is a chapter, to pay revisit user fees when
main provider and has one or more re- and if assessed.
mote locations of a hospital or one or (y) In the case of a hospital or crit-
more satellites, as these terms are de- ical access hospital, to provide notice,
fined in § 413.65(a)(2), § 412.22(h), or as specified in paragraphs (y)(1) and (2)
§ 412.25(e) of this chapter, as applicable, of this section, to each individual enti-
the determination is made separately tled to Medicare benefits under Title
for the main provider and each remote XVIII of the Act when such individual
location or satellite whether notice to receives observation services as an out-
patients is required. Notice is required patient for more than 24 hours. Notice
at each location at which inpatient must be provided to the individual not
services are furnished at which a doc- later than 36 hours after observation
tor of medicine or doctor of osteopathy services are initiated or sooner if the
is not present 24 hours per day, 7 days individual is transferred, discharged, or
per week. admitted. Notice may be provided be-
(3) The written notice must state fore such individual receives 24 hours
that the hospital does not have a doc- of observation services as an out-
tor of medicine or a doctor of osteop- patient.
athy present in the hospital 24 hours (1) Written notice. Hospitals and crit-
per day, 7 days per week, and must in- ical access hospitals must use a stand-
dicate how the hospital will meet the ardized written notice, as specified by
581
§ 489.21 42 CFR Ch. IV (10–1–17 Edition)
the Secretary, which includes the fol- § 489.21 Specific limitations on

lowing information: charges.
(i) An explanation of the status of Except as specified in subpart C of
the individual as an outpatient receiv- this part, the provider agrees not to
ing observation services and not as an charge a beneficiary for any of the fol-
inpatient of the hospital or critical ac- lowing:
cess hospital and the reason for status (a) Services for which the beneficiary
as an outpatient receiving observation is entitled to have payment made
services; and under Medicare.
(ii) An explanation of the implica- (b) Services for which the beneficiary
tions of such status as an outpatient on would be entitled to have payment
services furnished by the hospital or made if the provider—
(1) Had in its files the required cer-
critical access hospital (including serv-
tification and recertification by a phy-
ices furnished on an inpatient basis),
sician relating to the services fur-
such as Medicare cost-sharing require-
nished to the beneficiary;
ments, and subsequent eligibility for (2) Had furnished the information re-
Medicare coverage for skilled nursing quired by the intermediary in order to
facility services. determine the amount due the provider
(2) Oral notice. The hospital must give on behalf of the individual for the pe-
an oral explanation of the written noti- riod with respect to which payment is
fication described in paragraph (y)(1) of to be made or any prior period;
this section. (3) Had complied with the provisions
(3) Signature requirements. The writ- requiring timely utilization review of
ten notice specified in paragraph (y)(1) long stay cases so that a limitation on
of this section must either— days of service has not been imposed
(i) Be signed by the individual who under section 1866(d) of the Act (see
receives observation services as an out- subpart K of part 405 and part 482 of
patient or a person acting on the indi- this chapter for utilization review re-
vidual’s behalf to acknowledge receipt quirements); and
of such notification; or (4) Had obtained, from the bene-
ficiary or a person acting on his or her
(ii) If the individual who receives ob-
behalf, a written request for payment
servation services as an outpatient or
to be made to the provider, and had
the person acting on behalf of the indi- properly filed that request. (If the ben-
vidual refuses to provide the signature eficiary or person on his or her behalf
described in paragraph (y)(1) of this refuses to execute a written request,
section, is signed by the staff member the provider may charge the bene-
of the hospital or critical access hos- ficiary for all services furnished to him
pital who presented the written notifi- or her.)
cation and includes the name and title (c) Inpatient hospital services fur-
of the staff member, a certification nished to a beneficiary who exhausted
that the notification was presented, his or her Part A benefits, if CMS reim-
and the date and time the notification burses the provider for those services.
was presented. (d) Custodial care and services not
reasonable and necessary for the diag-
[45 FR 22937, Apr. 4, 1980]
nosis or treatment of illness or injury,
EDITORIAL NOTE: For FEDERAL REGISTER ci- if—
tations affecting § 489.20, see the List of CFR (1) The beneficiary was without fault
Sections Affected, which appears in the in incurring the expenses; and
Finding Aids section of the printed volume (2) The determination that payment
and at www.fdsys.gov. was incorrect was not made until after
EFFECTIVE DATE NOTE: At 59 FR 32120, June the third year following the year in
22, 1994, § 489.20(l) through (r) were added. which the payment notice was sent to
Paragraphs (m), (r)(2), and (r)(3) contain in- the beneficiary.
formation collection and recordkeeping re- (e) Inpatient hospital services for
quirements and will not become effective which a beneficiary would be entitled
until approval has been given by the Office of to have payment made under Part A of
Management and Budget. Medicare but for a denial or reduction
582
in payments under regulations at surance amount required under Medi-

§ 412.48 of this chapter or under section care.
1886(f) of the Act. (d) A provider may not charge an in-
(f) Items and services furnished to a dividual for (1) its agreement to admit
hospital inpatient (other than physi- or readmit the individual on some
cians’ services as described in specified future date for covered inpa-
§ 415.102(a) of this chapter or the serv- tient services; or (2) for failure to re-
ices of an anesthetist as described in main an inpatient for any agreed-upon
§ 405.553(b)(4) of this chapter) for which length of time or for failure to give ad-
Medicare payment would be made if vance notice of departure from the pro-
furnished by the hospital or by other vider’s facilities.
providers or suppliers under arrange- [45 FR 22937, Apr. 4, 1980, as amended at 68
ments made with them by the hospital. FR 46072, Aug. 4, 2003]
For this purpose, a charge by another
provider or supplier for such an item or § 489.23 Specific limitation on charges
service is treated as a charge by the for services provided to certain en-
rollees of fee-for-service FEHB
hospital for the item or service, and is plans.
also prohibited.
A provider that furnishes inpatient
(g) [Reserved]
hospital services to a retired Federal
(h) Items and services (other than worker age 65 or older who is enrolled
those described in § 489.20(s)(1) through in a fee-for-service FEHB plan and who
(15)) required to be furnished under is not covered under Medicare Part A,
§ 489.20(s) to a resident of an SNF (de- must accept, as payment in full, an
fined in § 411.15(p) of this chapter), for amount that approximates as closely
which Medicare payment would be as possible the Medicare inpatient hos-
made if furnished by the SNF or by pital prospective payment system
other providers or suppliers under ar- (PPS) rate established under part 412.
rangements made with them by the The payment to the provider is com-
SNF. For this purpose, a charge by an- posed of a payment from the FEHB
other provider or supplier for such an plan and a payment from the enrollee.
item or service is treated as a charge This combined payment approximates
by the SNF for the item or service, and the Medicare PPS rate. The payment
is also prohibited. from the FEHB plan approximates, as
[49 FR 324, Jan. 3, 1984, as amended at 51 FR closely as possible, the Medicare PPS
22052, June 17, 1986; 52 FR 27765, July 23, 1987; rate minus any applicable enrollee de-
60 FR 63189, Dec. 8, 1995; 64 FR 41683, July 30, ductible, coinsurance, or copayment
1999; 65 FR 46796, July 31, 2000; 65 FR 62646, amount. The payment from the en-
Oct. 19, 2000; 66 FR 39601, July 31, 2001] rollee is equal to the applicable deduct-
ible, coinsurance, or copayment
§ 489.22 Special provisions applicable amount.
to prepayment requirements.
[62 FR 56111, Oct. 29, 1997]
(a) A provider may not require an in-
dividual entitled to hospital insurance § 489.24 Special responsibilities of
benefits to prepay in part or in whole Medicare hospitals in emergency
for inpatient services as a condition of cases.
admittance as an inpatient, except (a) Applicability of provisions of this
where it is clear upon admission that section. (1) In the case of a hospital that
payment under Medicare, Part A can- has an emergency department, if an in-
not be made. dividual (whether or not eligible for
(b) A provider may not deny covered Medicare benefits and regardless of
inpatient services to an individual en- ability to pay) ‘‘comes to the emer-
titled to have payment made for those gency department’’, as defined in para-
services on the ground of inability or graph (b) of this section, the hospital
failure to pay a requested amount at or must—
before admission. (i) Provide an appropriate medical
(c) A provider may not evict, or screening examination within the capa-
threaten to evict, an individual for in- bility of the hospital’s emergency de-
ability to pay a deductible or a coin- partment, including ancillary services
583
§ 489.24 42 CFR Ch. IV (10–1–17 Edition)
routinely available to the emergency demic influenza), the waiver will con-
department, to determine whether or tinue in effect until the termination of
not an emergency medical condition the applicable declaration of a public
exists. The examination must be con- health emergency, as provided under
ducted by an individual(s) who is deter- section 1135(e)(1)(B) of the Act.
mined qualified by hospital bylaws or (b) Definitions. As used in this sub-
rules and regulations and who meets part—
the requirements of § 482.55 of this Capacity means the ability of the hos-
chapter concerning emergency services pital to accommodate the individual
personnel and direction; and requesting examination or treatment
(ii) If an emergency medical condi- of the transferred individual. Capacity
tion is determined to exist, provide any encompasses such things as numbers
necessary stabilizing treatment, as de- and availability of qualified staff, beds
fined in paragraph (d) of this section, and equipment and the hospital’s past
or an appropriate transfer as defined in practices of accommodating additional
paragraph (e) of this section. If the hos- patients in excess of its occupancy lim-
pital admits the individual as an inpa- its.
tient for further treatment, the hos- Comes to the emergency department
pital’s obligation under this section means, with respect to an individual
ends, as specified in paragraph (d)(2) of who is not a patient (as defined in this
this section. section), the individual—
(2)(i) When a waiver has been issued (1) Has presented at a hospital’s dedi-
in accordance with section 1135 of the cated emergency department, as de-
Act that includes a waiver under sec- fined in this section, and requests ex-
tion 1135(b)(3) of the Act, sanctions amination or treatment for a medical
under this section for an inappropriate condition, or has such a request made
transfer or for the direction or reloca- on his or her behalf. In the absence of
tion of an individual to receive medical such a request by or on behalf of the
screening at an alternate location do individual, a request on behalf of the
not apply to a hospital with a dedi- individual will be considered to exist if
cated emergency department if the fol- a prudent layperson observer would be-
lowing conditions are met: lieve, based on the individual’s appear-
(A) The transfer is necessitated by ance or behavior, that the individual
the circumstances of the declared needs examination or treatment for a
emergency in the emergency area dur- medical condition;
ing the emergency period. (2) Has presented on hospital prop-
(B) The direction or relocation of an erty, as defined in this section, other
individual to receive medical screening than the dedicated emergency depart-
at an alternate location is pursuant to ment, and requests examination or
an appropriate State emergency pre- treatment for what may be an emer-
paredness plan or, in the case of a pub- gency medical condition, or has such a
lic health emergency that involves a request made on his or her behalf. In
pandemic infectious disease, pursuant the absence of such a request by or on
to a State pandemic preparedness plan. behalf of the individual, a request on
(C) The hospital does not discrimi- behalf of the individual will be consid-
nate on the basis of an individual’s ered to exist if a prudent layperson ob-
source of payment or ability to pay. server would believe, based on the indi-
(D) The hospital is located in an vidual’s appearance or behavior, that
emergency area during an emergency the individual needs emergency exam-
period, as those terms are defined in ination or treatment;
section 1135(g)(1) of the Act. (3) Is in a ground or air ambulance
(E) There has been a determination owned and operated by the hospital for
that a waiver of sanctions is necessary. purposes of examination and treatment
(ii) A waiver of these sanctions is for a medical condition at a hospital’s
limited to a 72-hour period beginning dedicated emergency department, even
upon the implementation of a hospital if the ambulance is not on hospital
disaster protocol, except that, if a pub- grounds. However, an individual in an

lic health emergency involves a pan- ambulance owned and operated by the
demic infectious disease (such as pan- hospital is not considered to have
584
‘‘come to the hospital’s emergency de- on an urgent basis without requiring a

partment’’ if— previously scheduled appointment; or
(i) The ambulance is operated under (3) During the calendar year imme-
communitywide emergency medical diately preceding the calendar year in
service (EMS) protocols that direct it which a determination under this sec-
to transport the individual to a hos- tion is being made, based on a rep-
pital other than the hospital that owns resentative sample of patient visits
the ambulance; for example, to the that occurred during that calendar
closest appropriate facility. In this year, it provides at least one-third of
case, the individual is considered to all of its outpatient visits for the treat-
have come to the emergency department of emergency medical conditions
ment of the hospital to which the indi- on an urgent basis without requiring a
vidual is transported, at the time the previously scheduled appointment.
individual is brought onto hospital Emergency medical condition means—
property;
(1) A medical condition manifesting
(ii) The ambulance is operated at the
itself by acute symptoms of sufficient
direction of a physician who is not em-
severity (including severe pain, psy-
ployed or otherwise affiliated with the
hospital that owns the ambulance; or chiatric disturbances and/or symptoms
(4) Is in a ground or air nonhospital- of substance abuse) such that the ab-
owned ambulance on hospital property sence of immediate medical attention
for presentation for examination and could reasonably be expected to result
treatment for a medical condition at a in—
hospital’s dedicated emergency depart- (i) Placing the health of the indi-
ment. However, an individual in a non- vidual (or, with respect to a pregnant
hospital-owned ambulance off hospital woman, the health of the woman or her
property is not considered to have unborn child) in serious jeopardy;
come to the hospital’s emergency de- (ii) Serious impairment to bodily
partment, even if a member of the am- functions; or
bulance staff contacts the hospital by (iii) Serious dysfunction of any bod-
telephone or telemetry communica- ily organ or part; or
tions and informs the hospital that (2) With respect to a pregnant woman
they want to transport the individual who is having contractions—
to the hospital for examination and (i) That there is inadequate time to
treatment. The hospital may direct the effect a safe transfer to another hos-
ambulance to another facility if it is in pital before delivery; or
‘‘diversionary status,’’ that is, it does (ii) That transfer may pose a threat
not have the staff or facilities to ac- to the health or safety of the woman or
cept any additional emergency pa- the unborn child.
tients. If, however, the ambulance staff
Hospital includes a critical access
disregards the hospital’s diversion in-
hospital as defined in section
structions and transports the indi-
1861(mm)(1) of the Act.
vidual onto hospital property, the indi-
vidual is considered to have come to Hospital property means the entire
the emergency department. main hospital campus as defined in
Dedicated emergency department means § 413.65(b) of this chapter, including the
any department or facility of the hos- parking lot, sidewalk, and driveway,
pital, regardless of whether it is lo- but excluding other areas or structures
cated on or off the main hospital cam- of the hospital’s main building that are
pus, that meets at least one of the fol- not part of the hospital, such as physi-
lowing requirements: cian offices, rural health centers,
(1) It is licensed by the State in skilled nursing facilities, or other enti-
which it is located under applicable ties that participate separately under
State law as an emergency room or Medicare, or restaurants, shops, or
emergency department; other nonmedical facilities.
(2) It is held out to the public (by Hospital with an emergency department
name, posted signs, advertising, or means a hospital with a dedicated

other means) as a place that provides emergency department as defined in
care for emergency medical conditions this paragraph (b).
585
§ 489.24 42 CFR Ch. IV (10–1–17 Edition)
Inpatient means an individual who is necessary to assure, within reasonable

admitted to a hospital for bed occu- medical probability, that no material
pancy for purposes of receiving inpa- deterioration of the condition is likely
tient hospital services as described in to result from or occur during the
§ 409.10(a) of this chapter with the ex- transfer of the individual from a facil-
pectation that he or she will remain at ity or that, with respect to an ‘‘emer-
least overnight and occupy a bed even gency medical condition’’ as defined in
though the situation later develops this section under paragraph (2) of that
that the individual can be discharged definition, the woman has delivered the
or transferred to another hospital and child and the placenta.
does not actually use a hospital bed Transfer means the movement (in-
overnight. cluding the discharge) of an individual
Labor means the process of childbirth outside a hospital’s facilities at the di-
beginning with the latent or early rection of any person employed by (or
phase of labor and continuing through affiliated or associated, directly or in-
the delivery of the placenta. A woman directly, with) the hospital, but does
experiencing contractions is in true not include such a movement of an in-
labor unless a physician, certified dividual who (i) has been declared dead,
nurse-midwife, or other qualified med- or (ii) leaves the facility without the
ical person acting within his or her permission of any such person.
scope of practice as defined in hospital (c) Use of dedicated emergency depart-
medical staff bylaws and State law, ment for nonemergency services. If an in-
certifies that, after a reasonable time dividual comes to a hospital’s dedi-
of observation, the woman is in false cated emergency department and a re-
labor. quest is made on his or her behalf for
Participating hospital means (1) a hos- examination or treatment for a med-
pital or (2) a critical access hospital as ical condition, but the nature of the re-
defined in section 1861(mm)(1) of the quest makes it clear that the medical
Act that has entered into a Medicare condition is not of an emergency na-
provider agreement under section 1866 ture, the hospital is required only to
of the Act. perform such screening as would be ap-
Patient means— propriate for any individual presenting
(1) An individual who has begun to in that manner, to determine that the
receive outpatient services as part of individual does not have an emergency
an encounter, as defined in § 410.2 of medical condition.
this chapter, other than an encounter (d) Necessary stabilizing treatment for
that the hospital is obligated by this emergency medical conditions—(1) Gen-
section to provide; eral. Subject to the provisions of para-
(2) An individual who has been admit- graph (d)(2) of this section, if any indi-
ted as an inpatient, as defined in this vidual (whether or not eligible for
section. Medicare benefits) comes to a hospital
Stabilized means, with respect to an and the hospital determines that the
‘‘emergency medical condition’’ as de- individual has an emergency medical
fined in this section under paragraph condition, the hospital must provide ei-
(1) of that definition, that no material ther—
deterioration of the condition is likely, (i) Within the capabilities of the staff
within reasonable medical probability, and facilities available at the hospital,
to result from or occur during the for further medical examination and
transfer of the individual from a facil- treatment as required to stabilize the
ity or, with respect to an ‘‘emergency medical condition.
medical condition’’ as defined in this (ii) For transfer of the individual to
section under paragraph (2) of that def- another medical facility in accordance
inition, that the woman has delivered with paragraph (e) of this section.
the child and the placenta. (2) Exception: Application to inpatients.
To stabilize means, with respect to an (i) If a hospital has screened an indi-
‘‘emergency medical condition’’ as de- vidual under paragraph (a) of this sec-
fined in this section under paragraph tion and found the individual to have
(1) of that definition, to provide such an emergency medical condition, and
medical treatment of the condition admits that individual as an inpatient
586
in good faith in order to stabilize the propriate medical screening examina-

emergency medical condition, the hos- tion required under paragraph (a) of
pital has satisfied its special respon- this section, and initiated any further
sibilities under this section with re- medical examination and treatment
spect to that individual. that may be required to stabilize the
(ii) This section is not applicable to emergency medical condition under
an inpatient who was admitted for paragraph (d)(1) of this section.
elective (nonemergency) diagnosis or (iii) An emergency physician or non-
treatment. physician practitioner is not precluded
(iii) A hospital is required by the con- from contacting the individual’s physi-
ditions of participation for hospitals cian at any time to seek advice regard-
under part 482 of this chapter to pro- ing the individual’s medical history
vide care to its inpatients in accord- and needs that may be relevant to the
ance with those conditions of partici- medical treatment and screening of the
pation. patient, as long as this consultation
(3) Refusal to consent to treatment. A does not inappropriately delay services
hospital meets the requirements of required under paragraph (a) or para-
paragraph (d)(1)(i) of this section with graphs (d)(1) and (d)(2) of this section.
respect to an individual if the hospital (iv) Hospitals may follow reasonable
offers the individual the further med- registration processes for individuals
ical examination and treatment de- for whom examination or treatment is
scribed in that paragraph and informs required by this section, including ask-
the individual (or a person acting on
ing whether an individual is insured
the individual’s behalf) of the risks and
and, if so, what that insurance is, as
benefits to the individual of the exam-
long as that inquiry does not delay
ination and treatment, but the indi-
screening or treatment. Reasonable
vidual (or a person acting on the indi-
registration processes may not unduly
vidual’s behalf) does not consent to the
discourage individuals from remaining
examination or treatment. The med-
for further evaluation.
ical record must contain a description
of the examination, treatment, or both (5) Refusal to consent to transfer. A
if applicable, that was refused by or on hospital meets the requirements of
behalf of the individual. The hospital paragraph (d)(1)(ii) of this section with
must take all reasonable steps to se- respect to an individual if the hospital
cure the individual’s written informed offers to transfer the individual to an-
refusal (or that of the person acting on other medical facility in accordance
his or her behalf). The written docu- with paragraph (e) of this section and
ment should indicate that the person informs the individual (or a person act-
has been informed of the risks and ben- ing on his or her behalf) of the risks
efits of the examination or treatment, and benefits to the individual of the
or both. transfer, but the individual (or a per-
(4) Delay in examination or treatment. son acting on the individual’s behalf)
(i) A participating hospital may not does not consent to the transfer. The
delay providing an appropriate medical hospital must take all reasonable steps
screening examination required under to secure the individual’s written in-
paragraph (a) of this section or further formed refusal (or that of a person act-
medical examination and treatment re- ing on his or her behalf). The written
quired under paragraph (d)(1) of this document must indicate the person has
section in order to inquire about the been informed of the risks and benefits
individual’s method of payment or in- of the transfer and state the reasons
surance status. for the individual’s refusal. The med-
(ii) A participating hospital may not ical record must contain a description
seek, or direct an individual to seek, of the proposed transfer that was re-
authorization from the individual’s in- fused by or on behalf of the individual.
surance company for screening or sta- (e) Restricting transfer until the indi-
bilization services to be furnished by a vidual is stabilized—(1) General. If an in-
hospital, physician, or nonphysician dividual at a hospital has an emer-

practitioner to an individual until gency medical condition that has not
after the hospital has provided the ap- been stabilized (as defined in paragraph
587
§ 489.24 42 CFR Ch. IV (10–1–17 Edition)
(b) of this section), the hospital may (B) Has agreed to accept transfer of
not transfer the individual unless— the individual and to provide appro-
(i) The transfer is an appropriate priate medical treatment;
transfer (within the meaning of para- (iii) The transferring hospital sends
graph (e)(2) of this section); and to the receiving facility all medical
(ii)(A) The individual (or a legally re- records (or copies thereof) related to
sponsible person acting on the individ- the emergency condition which the in-
ual’s behalf) requests the transfer, dividual has presented that are avail-
after being informed of the hospital’s able at the time of the transfer, includ-
obligations under this section and of ing available history, records related
the risk of transfer. The request must to the individual’s emergency medical
be in writing and indicate the reasons condition, observations of signs or
for the request as well as indicate that symptoms, preliminary diagnosis, re-
he or she is aware of the risks and ben- sults of diagnostic studies or telephone
efits of the transfer; reports of the studies, treatment pro-
(B) A physician (within the meaning vided, results of any tests and the in-
of section 1861(r)(1) of the Act) has formed written consent or certification
signed a certification that, based upon (or copy thereof) required under para-
the information available at the time graph (e)(1)(ii) of this section, and the
of transfer, the medical benefits rea- name and address of any on-call physi-
sonably expected from the provision of cian (described in paragraph (g) of this
appropriate medical treatment at an- section) who has refused or failed to
other medical facility outweigh the in- appear within a reasonable time to pro-
creased risks to the individual or, in vide necessary stabilizing treatment.
the case of a woman in labor, to the Other records (e.g., test results not yet
woman or the unborn child, from being available or historical records not
transferred. The certification must readily available from the hospital’s
contain a summary of the risks and files) must be sent as soon as prac-
benefits upon which it is based; or ticable after transfer; and
(C) If a physician is not physically (iv) The transfer is effected through
present in the emergency department qualified personnel and transportation
at the time an individual is trans- equipment, as required, including the
ferred, a qualified medical person (as use of necessary and medically appro-
determined by the hospital in its by- priate life support measures during the
laws or rules and regulations) has transfer.
signed a certification described in (3) A participating hospital may not
paragraph (e)(1)(ii)(B) of this section penalize or take adverse action against
after a physician (as defined in section a physician or a qualified medical per-
1861(r)(1) of the Act) in consultation son described in paragraph (e)(1)(ii)(C)
with the qualified medical person, of this section because the physician or
agrees with the certification and subse- qualified medical person refuses to au-
quently countersigns the certification. thorize the transfer of an individual
The certification must contain a sum- with an emergency medical condition
mary of the risks and benefits upon that has not been stabilized, or against
which it is based. any hospital employee because the em-
(2) A transfer to another medical fa- ployee reports a violation of a require-
cility will be appropriate only in those ment of this section.
cases in which— (f) Recipient hospital responsibilities. A
(i) The transferring hospital provides participating hospital that has special-
medical treatment within its capacity ized capabilities or facilities (includ-
that minimizes the risks to the individ- ing, but not limited to, facilities such
ual’s health and, in the case of a as burn units, shock-trauma units, neo-
woman in labor, the health of the un- natal intensive case units, or, with re-
born child; spect to rural areas, regional referral
(ii) The receiving facility— centers (which, for purposes of this
(A) Has available space and qualified subpart, mean hospitals meeting the
personnel for the treatment of the indi- requirements of referral centers found
vidual; and at § 412.96 of this chapter)) may not
588
refuse to accept from a referring hos- (ii) Within 15 calendar days of receiv-
pital within the boundaries of the ing the case, the QIO gives written no-
United States an appropriate transfer tice, sent by certified mail, return re-
of an individual who requires such spe- ceipt requested, to the physician or the
cialized capabilities or facilities if the hospital (or both if applicable).
receiving hospital has the capacity to (iii)(A) The written notice must con-
treat the individual. tain the following information:
(1) The provisions of this paragraph (1) The name of each individual who
(f) apply to any participating hospital may have been the subject of the al-
with specialized capabilities, regardless leged violation.
of whether the hospital has a dedicated (2) The date on which each alleged
emergency department. violation occurred.
(2) The provisions of this paragraph (3) An invitation to meet, either by
(f) do not apply to an individual who telephone or in person, to discuss the
has been admitted to a referring hos- case with the QIO, and to submit addi-
pital under the provisions of paragraph tional information to the QIO within 30
(d)(2)(i) of this section. calendar days of receipt of the notice,
(g) Termination of provider agreement. and a statement that these rights will
If a hospital fails to meet the require- be waived if the invitation is not ac-
ments of paragraph (a) through (f) of cepted. The QIO must receive the infor-
this section, CMS may terminate the mation and hold the meeting within
provider agreement in accordance with the 30-day period.
§ 489.53. (4) A copy of the regulations at 42
(h) Consultation with Quality Improve- CFR 489.24.
ment Organizations (QIOs)—(1) General. (B) For purposes of paragraph
Except as provided in paragraph (h)(3) (h)(2)(iii)(A) of this section, the date of
of this section, in cases where a med- receipt is presumed to be 5 days after
ical opinion is necessary to determine the certified mail date on the notice,
a physician’s or hospital’s liability unless there is a reasonable showing to
under section 1867(d)(1) of the Act, CMS the contrary.
requests the appropriate QIO (with a (iv) The physician or hospital (or
contract under Part B of title XI of the both where applicable) may request a
Act) to review the alleged section meeting with the QIO. This meeting is
1867(d) violation and provide a report not designed to be a formal adversarial
on its findings in accordance with para- hearing or a mechanism for discovery
graph (h)(2)(iv) and (v) of this section. by the physician or hospital. The meet-
CMS provides to the QIO all informa- ing is intended to afford the physician
tion relevant to the case and within its and/or the hospital a full and fair op-
possession or control. CMS, in con- portunity to present the views of the
sultation with the OIG, also provides physician and/or hospital regarding the
to the QIO a list of relevant questions case. The following provisions apply to
to which the QIO must respond in its that meeting:
report. (A) The physician and/or hospital has
(2) Notice of review and opportunity for the right to have legal counsel present
discussion and additional information. during that meeting. However, the QIO
The QIO shall provide the physician may control the scope, extent, and
and hospital reasonable notice of its re- manner of any questioning or any
view, a reasonable opportunity for dis- other presentation by the attorney.
cussion, and an opportunity for the The QIO may also have legal counsel
physician and hospital to submit addi- present.
tional information before issuing its (B) The QIO makes arrangements so
report. When a QIO receives a request that, if requested by CMS or the OIG, a
for consultation under paragraph (h)(1) verbatim transcript of the meeting
of this section, the following provisions may be generated. If CMS or OIG re-
apply— quests a transcript, the affected physi-
(i) The QIO reviews the case before cian and/or the affected hospital may
the 15th calendar day and makes its request that CMS provide a copy of the
tentative findings. transcript.
589
§ 489.24 42 CFR Ch. IV (10–1–17 Edition)
(C) The QIO affords the physician exclusion in accordance with section
and/or the hospital an opportunity to 1867(d)(1) of the Act and 42 CFR part
present, with the assistance of counsel, 1003 of this title.
expert testimony in either oral or writ- (4) If the QIO determines after a pre-
ten form on the medical issues preliminary review that there was an ap-
sented. However, the QIO may reason- propriate medical screening examina-
ably limit the number of witnesses and tion and the individual did not have an
length of such testimony if such testi- emergency medical condition, as de-
mony is irrelevant or repetitive. The fined by paragraph (b) of this section,
physician and/or hospital, directly or then the QIO may, at its discretion, re-
through counsel, may disclose patient turn the case to CMS and not meet the
records to potential expert witnesses requirements of paragraph (h) except
without violating any non-disclosure for those in paragraph (h)(2)(v).
requirements set forth in part 476 of (i) Release of QIO assessments. Upon
this chapter. request, CMS may release a QIO assess-
(D) The QIO is not obligated to con- ment to the physician and/or hospital,
sider any additional information pro- or the affected individual, or his or her
vided by the physician and/or the hos- representative. The QIO physician’s
pital after the meeting, unless, before identity is confidential unless he or she
the end of the meeting, the QIO re- consents to its release. (See §§ 476.132
quests that the physician and/or hos- and 476.133 of this chapter.)
pital submit additional information to (j) Availability of on-call physicians. In
support the claims. The QIO then al- accordance with the on-call list re-
lows the physician and/or the hospital quirements specified in § 489.20(r)(2), a
an additional period of time, not to ex- hospital must have written policies and
ceed 5 calendar days from the meeting, procedures in place—
to submit the relevant information to (1) To respond to situations in which
the QIO. a particular specialty is not available
(v) Within 60 calendar days of receiv- or the on-call physician cannot respond
ing the case, the QIO must submit to because of circumstances beyond the
CMS a report on the QIO’s findings. physician’s control; and
CMS provides copies to the OIG and to
(2) To provide that emergency serv-
the affected physician and/or the af-
ices are available to meet the needs of
fected hospital. The report must con-
individuals with emergency medical
tain the name of the physician and/or
conditions if a hospital elects to—
the hospital, the name of the indi-
vidual, and the dates and times the in- (i) Permit on-call physicians to
schedule elective surgery during the
dividual arrived at and was transferred
time that they are on call;
(or discharged) from the hospital. The
report provides expert medical opinion (ii) Permit on-call physicians to have
regarding whether the individual in- simultaneous on-call duties; and
volved had an emergency medical con- (iii) Participate in a formal commu-
dition, whether the individual’s emer- nity call plan. Notwithstanding par-
gency medical condition was stabilized, ticipation in a community call plan,
whether the individual was transferred hospitals are still required to perform
appropriately, and whether there were medical screening examinations on in-
any medical utilization or quality of dividuals who present seeking treat-
care issues involved in the case. ment and to conduct appropriate trans-
(vi) The report required under para- fers. The formal community plan must
graph (h)(2)(v) of this section should include the following elements:
not state an opinion or conclusion as (A) A clear delineation of on-call cov-
to whether section 1867 of the Act or erage responsibilities; that is, when
§ 489.24 has been violated. each hospital participating in the plan
(3) If a delay would jeopardize the is responsible for on-call coverage.
health or safety of individuals or when (B) A description of the specific geo-
there was no screening examination, graphic area to which the plan applies.
the QIO review described in this sec- (C) A signature by an appropriate

tion is not required before the OIG may representative of each hospital partici-
impose civil monetary penalties or an pating in the plan.
590
(D) Assurances that any local and re- § 489.26 Special requirements con-
gional EMS system protocol formally cerning veterans.
includes information on community For inpatient services, a hospital
on-call arrangements. that participates in the Medicare pro-
(E) A statement specifying that even gram must admit any veteran whose
if an individual arrives at a hospital admission is authorized by the Depart-
that is not designated as the on-call ment of Veterans Affairs under 38
hospital, that hospital still has an obli- U.S.C. 603 and must meet the require-
gation under § 489.24 to provide a med- ments of 38 CFR part 17 concerning ad-
ical screening examination and stabi- missions practices and payment meth-
lizing treatment within its capability, odology and amounts. This section ap-
and that hospitals participating in the plies to services furnished to veterans
community call plan must abide by the admitted on and after July 1, 1987.
regulations under § 489.24 governing ap-
propriate transfers. [59 FR 32123, June 22, 1994]
(F) An annual assessment of the com-
§ 489.27 Beneficiary notice of dis-
munity call plan by the participating charge rights.
hospitals.
(a) A hospital that participates in the
[59 FR 32120, June 22, 1994, as amended at 62 Medicare program must furnish each
FR 46037, Aug. 29, 1997; 65 FR 18548, Apr. 7,
Medicare beneficiary or enrollee, (or an
2000; 65 FR 59748, Oct. 6, 2000; 66 FR 1599, Jan.
9, 2001; 66 FR 59923, Nov. 30, 2001; 68 FR 53262, individual acting on his or her behalf),
Sept. 9, 2003; 71 FR 48143, Aug. 18, 2006; 72 FR timely notice as required by section
47413, Aug. 22, 2007; 73 FR 48758, Aug. 19, 2008; 1866(A)(1)(M) of the Act and in accord-
74 FR 44001, Aug. 27, 2009; 78 FR 50971, Aug. ance with § 405.1205 and § 422.620. The
19, 2013] hospital must be able to demonstrate
EFFECTIVE DATE NOTE: At 59 FR 32120, June compliance with this requirement.
22, 1994, § 489.24 was added. Paragraphs (d) (b) Notification by hospitals and other
and (g) contain information collection and providers. Hospitals and other providers
recordkeeping requirements and will not be- (as identified at 489.2(b)) that partici-
come effective until approval has been given pate in the Medicare program must fur-
by the Office of Management and Budget. nish each Medicare beneficiary, or rep-
resentative, applicable CMS notices in
§ 489.25 Special requirements con-
cerning CHAMPUS and CHAMPVA advance of discharge or termination of
programs. Medicare services, including the no-
tices required under § 405.1200, § 405.1202,
For inpatient services, a hospital § 405.1206, and § 422.624 of this chapter.
that participates in the Medicare pro-
gram must participate in any health [71 FR 68724, Nov. 27, 2006]
plan contracted under 10 U.S.C. 1079 or
1086 (Civilian Health and Medical Pro- § 489.28 Special capitalization require-
ments for HHAs.
gram of the Uniformed Services) and
under 38 U.S.C. 613 (Civilian Health and (a) Basic rule. An HHA entering the
Medical Program of the Veterans Ad- Medicare program on or after January
ministration) and accept the 1, 1998, including a new HHA as a result
CHAMPUS/CHAMPVA-determined al- of a change of ownership, if the change
lowable amount as payment in full, of ownership results in a new provider
less applicable deductible, patient cost- number being issued, must have avail-
share, and noncovered items. Hospitals able sufficient funds, which we term
must meet the requirements of 32 CFR ‘‘initial reserve operating funds,’’ at
part 199 concerning program benefits the time of application submission and
under the Department of Defense. This at all times during the enrollment
section applies to inpatient services process up to the expiration of the 3-
furnished to beneficiaries admitted on month period following the conveyance
or after January 1, 1987. of Medicare billing privileges to oper-

ate the HHA for the three-month pe-
[59 FR 32123, June 22, 1994]
riod after Medicare billing privileges
591
§ 489.28 42 CFR Ch. IV (10–1–17 Edition)
are conveyed by the Medicare con- must provide CMS with adequate proof
tractor, exclusive of actual or proof the availability of initial reserve op-
jected accounts receivable from Medi- erating funds. Such proof, at a min-
care. imum, will include a copy of the state-
(b) Standard. Initial reserve operating ment(s) of the HHA’s savings, check-
funds are sufficient to meet the re- ing, or other account(s) that contains
quirement of this section if the total the funds, accompanied by an attesta-
amount of such funds is equal to or tion from an officer of the bank or
greater than the product of the actual other financial institution that the
average cost per visit of three or more funds are in the account(s) and that
similarly situated HHAs in their first the funds are immediately available to
year of operation (selected by CMS for the HHA. In some cases, an HHA may
comparative purposes) multiplied by have all or part of the initial reserve
the number of visits projected by the operating funds in cash equivalents.
HHA for its first three months of oper- For the purpose of this section, cash
ation—or 22.5 percent (one fourth of 90 equivalents are short-term, highly liq-
percent) of the average number of vis- uid investments that are readily con-
its reported by the comparison HHAs— vertible to known amounts of cash and
whichever is greater. that present insignificant risk of
(c) Method. CMS, through the inter- changes in value. A cash equivalent
mediary, will determine the amount of that is not readily convertible to a
the initial reserve operating funds known amount of cash as needed dur-
using reported cost and visit data from ing the initial three month period for
submitted cost reports for the first full which the initial reserve operating
year of operation from at least three funds are required does not qualify in
HHAs that the intermediary serves meeting the initial reserve operating
that are comparable to the HHA that is funds requirement. Examples of cash
seeking to enter the Medicare program, equivalents for the purpose of this sec-
considering such factors as geographic tion are Treasury bills, commercial
location and urban/rural status, num- paper, and money market funds. As
ber of visits, provider-based versus with funds in a checking, savings, or
free-standing, and proprietary versus other account, the HHA also must be
non-proprietary status. The determina- able to document the availability of
tion of the adequacy of the required any cash equivalents. CMS later may
initial reserve operating funds is based require the HHA to furnish another at-
on the average cost per visit of the testation from the financial institution
comparable HHAs, by dividing the sum that the funds remain available, or, if
of total reported costs of the HHAs in applicable, documentation from the
their first year of operation by the sum HHA that any cash equivalents remain
of the HHAs’ total reported visits. The available, until a date when the HHA
resulting average cost per visit is then will have been surveyed by the State
multiplied by the projected visits for agency or by an approved accrediting
the first three months of operation of organization. The officer of the HHA
the HHA seeking to enter the program, who will be certifying the accuracy of
but not less than 90 percent of average the information on the HHA’s cost re-
visits for a three month period for the port must certify what portion of the
HHAs used in determining the average required initial reserve operating funds
cost per visit. is non-borrowed funds, including funds
(1) In selecting the comparative invested in the business by the owner.
HHAs as described in this paragraph That amount must be at least 50 per-
(c), the CMS contractor shall only se- cent of the required initial reserve op-
lect HHAs that have provided cost re- erating funds. The remainder of the re-
ports to Medicare. When selecting cost serve operating funds may be secured
reports for the comparative analysis, through borrowing or line of credit
CMS will exclude low utilization or no from an unrelated lender.
utilization cost reports. (e) Borrowed funds. If borrowed funds
(2) [Reserved] are not in the same account(s) as the

(d) Required proof of availability of ini- HHA’s own non-borrowed funds, the
tial reserve operating funds. The HHA HHA also must provide proof that the
592
borrowed funds are available for use in inpatient hospital services must accept
operating the HHA, by providing, at a the payment methodology and no more
minimum, a copy of the statement(s) than the rates of payment established
of the HHA’s savings, checking, or under 42 CFR part 136, subpart D as
other account(s) containing the bor- payment in full for the following pro-
rowed funds, accompanied by an attes- grams:
tation from an officer of the bank or (1) A contract health service (CHS)
other financial institution that the program under 42 CFR part 136, subpart
funds are in the account(s) and are im- C, of the Indian Health Service (IHS);
mediately available to the HHA. As (2) A CHS program under 42 CFR part
with the HHA’s own (that is, non-bor- 136, subpart C, carried out by an Indian
rowed) funds, CMS later may require Tribe or Tribal organization pursuant
the HHA to establish the current avail- to the Indian Self-Determination and
ability of such borrowed funds, includ- Education Assistance Act, as amended,
ing furnishing an attestation from a fi- Public Law 93–638, 25 U.S.C. 450 et seq.;
nancial institution or other source, as and
may be appropriate, and to establish (3) A program funded through a grant
that such funds will remain available or contract by the IHS and operated by
until a date when the HHA will have an urban Indian organization under
been surveyed by the State agency or which items and services are purchased
by an approved accrediting organiza- for an eligible urban Indian (as those
tion. terms are defined in 25 U.S.C. 1603 (f)
(f) Line of credit. If the HHA chooses and (h)).
to support the availability of a portion (b) Hospitals and critical access hos-
of the initial reserve operating funds pitals may not refuse service to an in-
with a line of credit, it must provide dividual on the basis that the payment
CMS with a letter of credit from the for such service is authorized under
lender. CMS later may require the HHA programs described in paragraph (a) of
to furnish an attestation from the this section.
lender that the HHA, upon its certifi-
[72 FR 30711, June 4, 2007]
cation into the Medicare program, con-
tinues to be approved to borrow the
amount specified in the letter of credit. Subpart C—Allowable Charges
(g) Billing Privileges. (1) CMS may
deny Medicare billing privileges to an § 489.30 Allowable charges:
Deductibles and coinsurance.
HHA unless the HHA meets the initial
reserve operating funds requirements (a) Part A deductible and coinsurance.
of this section. The provider may charge the bene-
(2) CMS may revoke the Medicare ficiary or other person on his or her be-
billing privileges of an HHA that fails half:
to maintain and comply with the ini- (1) The amount of the inpatient hos-
tial reserve operating funds require- pital deductible or, if less, the actual
ments of this section for the three- charges for the services;
month period after it receives its Medi- (2) The amount of inpatient hospital
care billing privileges. coinsurance applicable for each day the
individual is furnished inpatient hos-
[63 FR 312, Jan. 5, 1998, as amended at 75 FR
70465, Nov. 17, 2010]
pital services after the 60th day, during
a benefit period; and
§ 489.29 Special requirements con- (3) The posthospital SNF care coin-
cerning beneficiaries served by the surance amount.
Indian Health Service, Tribal health (4) In the case of durable medical
programs, and urban Indian organi- equipment (DME) furnished as a home
zation health programs. health service, 20 percent of the cus-
(a) Hospitals (as defined in sections tomary charge for the service.
1861(e) and (f) of the Social Security (b) Part B deductible and coinsurance.
Act) and critical access hospitals (as (1) The basic allowable charges are the
defined in section 1861(mm)(1) of the $75 deductible and 20 percent of the

Social Security Act) that participate customary (insofar as reasonable)
in the Medicare program and furnish charges in excess of that deductible.
593
§ 489.31 42 CFR Ch. IV (10–1–17 Edition)
(2) For hospital outpatient services, that excess will be deducted from any
the allowable deductible charges de- Medicare payments due the provider.
pend on whether the hospital can de- [56 FR 23022, May 20, 1991, as amended at 57
termine the beneficiary’s deductible FR 36018, Aug. 12, 1992]
status.
(i) If the hospital is unable to deter- § 489.32 Allowable charges: Non-
mine the deductible status, it may covered and partially covered serv-
ices.
charge the beneficiary its full cus-
tomary charges up to $75. (a) Services requested by beneficiary. If
(ii) If the beneficiary provides official services furnished at the request of a
beneficiary (or his or her representa-
information as to deductible status,
tive) are more expensive than, or in ex-
the hospital may charge only the
cess of, services covered under Medi-
unmet portion of the deductible.
care—
(3) In either of the cases discussed in (1) A provider may charge the bene-
paragraph (b)(2) of this section, the ficiary an amount that does not exceed
hospital is required to file with the the difference between—
intermediary, on a form prescribed by (i) The provider’s customary charges
CMS, information as to the services, for the services furnished; and
charges, and amounts collected. (ii) The provider’s customary charges
(4) The intermediary must reimburse for the kinds and amounts of services
the beneficiary if reimbursement is au- that are covered under Medicare.
thorized and credit the expenses to the (2) A provider may not charge for the
beneficiary’s deductible if the deduct- services unless they have been re-
ible has not yet been met. quested by the beneficiary (or his or
(5) In the case of DME furnished as a her representative) nor require a bene-
home health service under Medicare ficiary to request services as a condi-
Part B, the coinsurance is 20 percent of tion of admission.
(3) To avoid misunderstanding and
the customary (insofar as reasonable)
disputes, a provider must inform any
charge for the services, with the fol-
beneficiary who requests a service for
lowing exception: If the DME is used
which a charge will be made that there
DME purchased by or on behalf of the will be a specified charge for that serv-
beneficiary at a price at least 25 per- ice.
cent less than the reasonable charge (b) Services not requested by the bene-
for comparable new equipment, no co- ficiary. For special provisions that
insurance is required. apply when a provider customarily fur-
[45 FR 22937, Apr. 4, 1980, as amended at 51 nishes more expensive services, see
FR 41350, Nov. 14, 1986] § 413.35 of this chapter.
§ 489.31 Allowable charges: Blood. FR 34833, Sept. 30, 1986]
(a) Limitations on charges. (1) A pro-
§ 489.34 Allowable charges: Hospitals
vider may charge the beneficiary (or participating in State reimburse-
other person on his or her behalf) only ment control systems or demonstra-
for the first three pints of blood or tion projects.
units of packed red cells furnished A hospital receiving payment for a
under Medicare Part A during a cal- covered hospital stay under either a
endar year, or furnished under Medi- State reimbursement control system
care Part B during a calendar year. approved under 1886(c) of the Act or a
(2) The charges may not exceed the demonstration project authorized
provider’s customary charges. under section 402(a) of Pub. L. 90–248 (42
(3) The provider may not charge for U.S.C. 1395b–1) or section 222(a) of Pub.
any whole blood or packed red cells in L. 92–603 (42 U.S.C. 1395b–1 (note)) and
any of the circumstances specified in that would otherwise be subject to the
§ 409.87(c)(2) of this chapter. prospective payment system set forth
(b) Offset for excessive charges. If the in part 412 of this chapter may charge
charge exceeds the cost to the provider, a beneficiary for noncovered services
as follows:
594
(a) For the custodial care and medi- may be offset against amounts other-
cally unnecessary services described in wise due the provider.
§ 412.42(c) of this chapter, after the con-
ditions of § 412.42(c)(1) through (c)(4) are § 489.42 Payment of offset amounts to
met; and beneficiary or other person.
(b) For all other services in accord- (a) In order to carry out the commit-
ance with the applicable rules of this ment to refund amounts incorrectly
subpart C. collected, CMS may determine that
amounts offset in accordance with
[54 FR 41747, Oct. 11, 1989]
§ 489.41 are to be paid directly to the
§ 489.35 Notice to intermediary. beneficiary or other person from whom
the provider received the incorrect col-
The provider must inform its inter- lection, if:
mediary of any amounts collected from (1) CMS finds that the provider has
a beneficiary or from other persons on failed, following written request, to re-
his or her behalf. fund the amount of the incorrect col-
lection to the beneficiary or other per-
Subpart D—Handling of Incorrect son; and
Collections (2) The provider agreement has been
terminated in accordance with the pro-
§ 489.40 Definition of incorrect collec- visions of subpart E of this part.
tion. (b) Before making a determination to
(a) As used in this subpart, ‘‘incor- make payment under paragraph (a) of
rect collections’’ means any amounts this section, CMS will give written no-
collected from a beneficiary (or some- tice to the provider (1) explaining that
one on his or her behalf) that are not an incorrect collection was made and
authorized under subpart C of this part. the amount; (2) requesting the provider
(b) A payment properly made to a to refund the incorrect collection to
provider by an individual not consid- the beneficiary or other person; and (3)
ered entitled to Medicare benefits will advising of CMS’s intention to make a
be deemed to be an ‘‘incorrect collec- determination under paragraph (a) of
tion’’ when the individual is found to this section.
be retroactively entitled to benefits. (c) The notice will afford an author-
ized official of the provider an oppor-
§ 489.41 Timing and methods of han- tunity to submit, within 20 days from
dling. the date on the notice, written state-
(a) Refund. Prompt refund to the ben- ment or evidence with respect to the
eficiary or other person is the preferred incorrect collection and/or offset
method of handling incorrect collec- amounts. CMS will consider any writ-
tions. ten statement or evidence in making a
(b) Setting aside. If the provider can- determination.
not refund within 60 days from the date (d) Payment to a beneficiary or other
on the notice of incorrect collection, it person under the provisions of para-
must set aside an amount, equal to the graph (a) of this section:
(1) Will not exceed the amount of the
amount incorrectly collected, in a sep-
incorrect collection; and
arate account identified as to the indi-
(2) May be considered as payment
vidual to whom the payment is due.
made to the provider.
This amount incorrectly collected
must be carried on the provider’s
records in this manner until final dis- Subpart E—Termination of Agree-
position is made in accordance with ment and Reinstatement After
the applicable State law. Termination
(c) Notice to, and action by, inter-
mediary. (1) The provider must notify § 489.52 Termination by the provider.
the intermediary of the refund or set- (a) Notice to CMS. (1) A provider that
ting aside required under paragraphs wishes to terminate its agreement, ex-
(a) and (b) of this section. cept for a SNF as specified in para-
(2) If the provider fails to refund or graph (a)(2) of this section, must send
set aside the required amounts, they CMS written notice of its intention in
595
§ 489.53 42 CFR Ch. IV (10–1–17 Edition)
accordance with paragraph (a)(3) of ble regulations of this chapter or with

this section. the provisions of the agreement.
(2) A SNF that wishes to terminate (2) The provider or supplier places re-
its agreement due to closure of the fa- strictions on the persons it will accept
cility must send CMS written notice of for treatment and it fails either to ex-
its intention at least 60 days prior to empt Medicare beneficiaries from those
the date of closure, as required at restrictions or to apply them to Medi-
§ 483.70(l) of this chapter. care beneficiaries the same as to all
(3) The notice may state the intended other persons seeking care.
date of termination which must be the (3) It no longer meets the appropriate
first day of the month. conditions of participation or require-
(b) Termination date. (1) If the notice ments (for SNFs and NFs) set forth
does not specify a date, or the date is elsewhere in this chapter. In the case
not acceptable to CMS, CMS may set a of an RNHCI no longer meets the con-
date that will not be more than 6 ditions for coverage, conditions of par-
months from the date on the provider’s ticipation and requirements set forth
notice of intent. elsewhere in this chapter.
(2) CMS may accept a termination (4) It fails to furnish information
date that is less than 6 months after that CMS finds necessary for a deter-
the date on the provider’s notice if it mination as to whether payments are
determines that to do so would not un- or were due under Medicare and the
duly disrupt services to the community amounts due.
or otherwise interfere with the effec- (5) It refuses to permit examination
tive and efficient administration of the of its fiscal or other records by, or on
Medicare program. behalf of CMS, as necessary for
(3) A cessation of business is deemed verification of information furnished
to be a termination by the provider, ef- as a basis for payment under Medicare.
fective with the date on which it (6) It failed to furnish information on
stopped providing services to the com- business transactions as required in
munity. § 420.205 of this chapter.
(c) Public notice. (1) The provider (7) It failed at the time the agree-
must give notice to the public at least ment was entered into or renewed to
15 days before the effective date of ter- disclose information on convicted indi-
mination. viduals as required in § 420.204 of this
(2) The notice must— chapter.
(i) Specify the termination date; and (8) It failed to furnish ownership in-
(ii) Explain to what extent services formation as required in § 420.206 of this
may continue after that date, in ac- chapter.
cordance with the exceptions set forth (9) It failed to comply with civil
in § 489.55. rights requirements set forth in 45 CFR
[45 FR 22937, Apr. 4, 1980, as amended at 76 parts 80, 84, and 90.
FR 9512, Feb. 18, 2011; 81 FR 68872, Oct. 4, 2016; (10) In the case of a hospital or a crit-
82 FR 38516, Aug. 14, 2017] ical access hospital as defined in sec-
tion 1861(mm)(1) of the Act that has
§ 489.53 Termination by CMS. reason to believe it may have received
(a) Basis for termination of agreement. an individual transferred by another
CMS may terminate the agreement hospital in violation of § 489.24(d), the
with any provider if CMS finds that hospital failed to report the incident to
any of the following failings is attrib- CMS or the State survey agency.
utable to that provider, and may, in (11) In the case of a hospital re-
addition to the applicable require- quested to furnish inpatient services to
ments in this chapter governing the CHAMPUS or CHAMPVA beneficiaries
termination of agreements with sup- or to veterans, it failed to comply with
pliers, terminate the agreement with § 489.25 or § 489.26, respectively.
any supplier to which the failings in (12) It failed to furnish the notice of
paragraphs (a)(2), (13) and (18) of this discharge rights as required by § 489.27.
section are attributable: (13) The provider or supplier refuses

(1) It is not complying with the pro- to permit copying of any records or
visions of title XVIII and the applica- other information by, or on behalf of,
596
CMS, as necessary to determine or is, entrance, admitting area, waiting

verify compliance with participation room, treatment area), signs specifying
requirements. rights of individuals under this sub-
(14) The hospital knowingly and will- part, to post conspicuously informa-
fully fails to accept, on a repeated tion indicating whether or not the hos-
basis, an amount that approximates pital participates in the Medicaid pro-
the Medicare rate established under gram, and to maintain medical and
the inpatient hospital prospective pay- other records related to transferred in-
ment system, minus any enrollee dividuals for a period of 5 years, a list
deductibles or copayments, as payment of on-call physicians for individuals
in full from a fee-for-service FEHB with emergency medical conditions,
plan for inpatient hospital services pro- and a central log on each individual
vided to a retired Federal enrollee of a who comes to the emergency depart-
fee-for-service FEHB plan, age 65 or ment seeking assistance.
older, who does not have Medicare Part (c) Termination of agreements with hos-
A benefits. pitals that fail to make required disclo-
(15) It had its enrollment in the Medi- sures. In the case of a physician-owned
care program revoked in accordance to hospital, as defined at § 489.3, CMS may
§ 424.535 of this chapter. terminate the provider agreement if
(16) It has failed to pay a revisit user the hospital failed to comply with the
fee when and if assessed. requirements of § 489.20(u) or (w). In the
(17) In the case of an HHA, it failed to case of other participating hospitals, as
correct any deficiencies within the re- defined at § 489.24, CMS may terminate
quired time frame. the provider agreement if the partici-
(18) The provider or supplier fails to pating hospital failed to comply with
grant immediate access upon a reason- the requirements of § 489.20(w).
able request to a state survey agency (d) Notice of termination—(1) Timing:
or other authorized entity for the pur- basic rule. Except as provided in para-
pose of determining, in accordance graphs (d)(2) and (d)(3) of this section,
with § 488.3, whether the provider or CMS gives the provider notice of termi-
supplier meets the applicable require- nation at least 15 days before the effec-
ments, conditions of participation, con- tive date of termination of the provider
ditions for coverage, or conditions for agreement.
certification. (2) Timing exceptions: Immediate jeop-
(b) Termination of agreements with cer- ardy situations—(i) Hospitals. If CMS
tain hospitals. In the case of a hospital finds that a hospital is in violation of
or critical access hospital that has an § 489.24(a) through (f), and CMS deter-
emergency department, as defined in mines that the violation poses imme-
§ 489.24(b), CMS may terminate the pro- diate jeopardy to the health or safety
vider agreement if— of individuals who present themselves
(1) The hospital fails to comply with to the hospital for emergency services,
the requirements of § 489.24 (a) through CMS—
(e), which require the hospital to exam- (A) Gives the hospital a preliminary
ine, treat, or transfer emergency med- notice indicating that its provider
ical condition cases appropriately, and agreement will be terminated in 23
require that hospitals with specialized days if it does not correct the identi-
capabilities or facilities accept an ap- fied deficiencies or refute the finding;
propriate transfer; or and
(2) The hospital fails to comply with (B) Gives a final notice of termi-
§ 489.20(m), (q), and (r), which require nation, and concurrent notice to the
the hospital to report suspected viola- public, at least 2 , but not more than 4,
tions of § 489.24(e), to post conspicu- days before the effective date of termi-
ously in emergency departments or in nation of the provider agreement.
a place or places likely to be noticed (ii) Skilled nursing facilities (SNFs).
by all individuals entering the emer- For an SNF with deficiencies that pose
gency departments, as well as those in- immediate jeopardy to the health or
dividuals waiting for examination and safety of residents, CMS gives notice at
treatment in areas other than tradi- least 2 days before the effective date of
tional emergency departments, (that termination of the provider agreement.
597
§ 489.54 42 CFR Ch. IV (10–1–17 Edition)
(iii) Home health agencies (HHAs). For the grounds that the provider and the
an HHA with deficiencies that pose im- beneficiary could not reasonably be ex-
mediate jeopardy to the health and pected to know that payment would
safety of patients, CMS gives notice to not be made. (The rules for deter-
the HHA at least 2 days before the ef- mining such lack of knowledge are set
fective date of termination of the pro- forth in §§ 405.330 through 405.334 of this
vider agreement. chapter.)
(3) Notice of LTC facility closure. In the (b) Notice of termination. The OIG will
case of a facility where CMS termi-
give the provider notice of termination
nates a facility’s participation under
Medicare or Medicaid in the absence of at least 15 days before the effective
immediate jeopardy, CMS determines date of termination of the agreement,
the appropriate date for notification. and will concurrently give notice of
(4) Content of notice. The notice states termination to the public.
the reasons for, and the effective date (c) Appeal by the provider. A provider
of, the termination, and explains the may appeal a termination of its agree-
extent to which services may continue ment by the OIG in accordance with
after that date, in accordance with subpart O of part 405 of this chapter.
§ 489.55. (d) Other applicable rules. The termi-
(5) Notice to public. CMS concurrently nation of a provider agreement by the
gives notice of the termination to the OIG is subject to the additional proce-
public. dures specified in §§ 1001.105 through
(e) Appeal by the provider. A provider 1001.109 of this title for notice and ap-
may appeal the termination of its pro- peals.
vider agreement by CMS in accordance
with part 498 of this chapter. [51 FR 24492, July 3, 1986, as amended at 51
FR 34788, Sept. 30, 1986]
[51 FR 24492, July 3, 1986]
EDITORIAL NOTE: For FEDERAL REGISTER ci- § 489.55 Exceptions to effective date of
tations affecting § 489.53, see the List of CFR termination.
Sections Affected, which appears in the
(a) Payment is available for up to 30
Finding Aids section of the printed volume
and at www.fdsys.gov. days after the effective date of termi-
nation for:
§ 489.54 Termination by the OIG. (1) Inpatient hospital services (in-
(a) Basis for termination. (1) The OIG cluding inpatient psychiatric hospital
may terminate the agreement of any services) and post hospital extended
provider if the OIG finds that any of care services (except as specified in
the following failings can be attributed paragraph (b) of this section with re-
to that provider. spect to LTC facilities) furnished to a
(i) It has knowingly and willfully beneficiary who was admitted before
made, or caused to be made, any false the effective date of termination; and
statement or representation of a mate- (2) Home health services and hospice
rial fact for use in an application or re- care furnished under a plan established
quest for payment under Medicare. before the effective date of termi-
(ii) It has submitted, or caused to be nation.
submitted, requests for Medicare pay- (b) The Secretary may, as the Sec-
ment of amounts that substantially ex- retary determines is appropriate, con-
ceed the costs it incurred in furnishing tinue to make payments with respect
the services for which payment is re- to residents of a long-term care facility
quested. that has submitted a notification of
(iii) It has furnished services that the
closure as required at § 483.70(l) of this
OIG has determined to be substantially
chapter during the period beginning on
in excess of the needs of individuals or
of a quality that fails to meet profes- the date such notification is submitted
sionally recognized standards of health and ending on the date on which the
care. The OIG will not terminate a pro- residents are successfully relocated.
vider agreement under paragraph (a) if [76 FR 9512, Feb. 18, 2011, as amended at 78
CMS has waived a disallowance with FR 16805, Mar. 19, 2013; 81 FR 68872, Oct. 4,
respect to the services in question on 2016]
598
§ 489.57 Reinstatement after termi- the bond otherwise meets the require-
nation. ments of this section.
When a provider agreement has been Unpaid civil money penalty or assess-
terminated by CMS under § 489.53, or by ment means a civil money penalty or
the OIG under § 489.54, a new agreement assessment imposed by CMS on an
with that provider will not be accepted HHA under Titles XI, XVIII, or XXI of
unless CMS or the OIG, as appropriate, the Social Security Act, plus accrued
finds— interest, that, after the HHA or Surety
(a) That the reason for termination has exhausted all administrative ap-
of the previous agreement has been re- peals, remains unpaid (because the
moved and there is reasonable assur- civil money penalty or assessment has
ance that it will not recur; and not been paid to, or offset or com-
(b) That the provider has fulfilled, or promised by, CMS) and is not the sub-
has made satisfactory arrangements to ject of a written arrangement, accept-
fulfill, all of the statutory and regu- able to CMS, for payment by the HHA.
latory responsibilities of its previous In the event a written arrangement for
agreement. payment, acceptable to CMS, is made,
an unpaid civil money penalty or assess-
[51 FR 24493, July 3, 1986] ment also means such civil money pen-
alty or assessment, plus accrued inter-
Subpart F—Surety Bond est, that remains due 60 days after the
Requirements for HHAs HHA’s default on such arrangement.
Unpaid claim means a Medicare over-
SOURCE: 63 FR 313, Jan. 5, 1998, unless oth-
payment for which the HHA is respon-
erwise noted. sible, plus accrued interest, that, 90
days after the date of the agency’s no-
§ 489.60 Definitions. tice to the HHA of the overpayment,
As used in this subpart unless the remains due (because the overpayment
context indicates otherwise— has not been paid to, or recouped or
Assessment means a sum certain that compromised by, CMS) and is not the
CMS may assess against an HHA in subject of a written arrangement, ac-
lieu of damages under Titles XI, XVIII, ceptable to CMS, for payment by the
or XXI of the Social Security Act or HHA. In the event a written arrange-
under regulations in this chapter. ment for payment, acceptable to CMS,
Assets includes but is not limited to is made, an unpaid claim also means a
any listing that identifies Medicare Medicare overpayment for which the
beneficiaries to whom home health HHA is responsible, plus accrued inter-
services were furnished by a partici- est, that remains due 60 days after the
pating or formerly participating HHA. HHA’s default on such arrangement.
Civil money penalty means a sum cer- [63 FR 313, Jan. 5, 1998, as amended at 63 FR
tain that CMS has the authority to im- 29655, June 1, 1998]
pose on an HHA as a penalty under Ti-
tles XI, XVIII, or XXI of the Social Se- § 489.61 Basic requirement for surety
curity Act or under regulations in this bonds.
chapter. Except as provided in § 489.62, each
Participating home health agency HHA that is a Medicare participating
means a ‘‘home health agency’’ (HHA), HHA, or that seeks to become a Medi-
as that term is defined by section care participating HHA, must obtain a
1861(o) of the Social Security Act, that surety bond (and furnish to CMS a copy
also meets the definition of a ‘‘proof such surety bond) that meets the re-
vider’’ set forth at § 400.202 of this chap- quirements of this subpart F and
ter. CMS’s instructions.
Rider means a notice issued by a Sur-
ety that a change in the bond has oc- § 489.62 Requirement waived for Gov-
curred or will occur. ernment-operated HHAs.
Surety bond means one or more bonds An HHA operated by a Federal,
issued by one or more surety compa- State, local, or tribal government

nies under 31 U.S.C. 9304 to 9308 and 31 agency is deemed to have provided
CFR parts 223, 224, and 225, provided CMS with a comparable surety bond
599
§ 489.63 42 CFR Ch. IV (10–1–17 Edition)
under State law, and CMS therefore (3) For other good cause.
waives the requirements of this sub- (d) Any determination CMS makes
part with respect to such an HHA if, under paragraph (c) of this section is
during the preceding 5 years the HHA effective immediately when notice of
has— the determination is published in the
(a) Not had any unpaid claims or un- FEDERAL REGISTER and remains in ef-
paid civil money penalties or assess- fect until a notice of reinstatement is
ments; and published in the FEDERAL REGISTER.
(b) Not had any of its claims referred (e) Any determination CMS makes
by CMS to the Department of Justice under paragraph (c) of this section does
or the General Accounting Office in ac- not affect the Surety’s liability under
cordance with part 401 of this chapter. any surety bond issued by a surety
[63 FR 313, Jan. 5, 1998, as amended at 63 FR company to an HHA before notice of
29655, June 1, 1998] such determination is published in ac-
cordance with paragraph (d) of this sec-
§ 489.63 Parties to the bond. tion.
The surety bond must name the HHA (f) A determination by CMS that a
as Principal, CMS as Obligee, and the surety company is an unauthorized
surety company (and its heirs, execu- Surety under this section is not a de-
tors, administrators, successors and as- barment, suspension, or exclusion for
signees, jointly and severally) as Sur- the purposes of Executive Order No.
ety. 12549 (3 CFR, 1986 comp., p. 189).
§ 489.64 Authorized Surety and exclu- § 489.65 Amount of the bond.

sion of surety companies. (a) Basic rule. The amount of the sur-
(a) An HHA may obtain a surety bond ety bond must be $50,000 or 15 percent
required under § 489.61 only from an au- of the Medicare payments made by
thorized Surety. CMS to the HHA in the HHA’s most re-
(b) An authorized Surety is a surety cent fiscal year for which a cost report
company that— has been accepted by CMS, whichever
(1) Has been issued a Certificate of is greater.
Authority by the U.S. Department of (b) Computation of the 15 percent: Par-
the Treasury in accordance with 31 ticipating HHA. The 15 percent is com-
U.S.C. 9304 to 9308 and 31 CFR parts 223, puted as follows:
224, and 225 as an acceptable surety on (1) For the initial bond—on the basis
Federal bonds and the Certificate has of Medicare payments made by CMS to
neither expired nor been revoked; and the HHA in the HHA’s most recent fis-
(2) Has not been determined by CMS cal year as shown in the HHA’s most
to be an unauthorized Surety for the recent cost report that has been ac-
purpose of an HHA obtaining a surety cepted by CMS. If the initial bond will
bond under this section. cover less than a full fiscal year, the
(c) CMS determines that a surety computation of the 15 percent will be
company is an unauthorized Surety based on the number of months of the
under this section— fiscal year that the bond will cover.
(1) If, upon request by CMS, the sur- (2) For subsequent bonds—on the
ety company fails to furnish timely basis of Medicare payments made by
confirmation of the issuance of, and CMS in the most recent fiscal year for
the validity and accuracy of informa- which a cost report has been accepted.
tion appearing on, a surety bond an However, if payments in the first six
HHA presents to CMS that shows the months of the current fiscal year differ
surety company as Surety on the bond; from such an amount by more than 25
(2) If, upon presentation by CMS to percent, then the amount of the bond is
the surety company of a request for 15 percent of such payments projected
payment on a surety bond and of suffi- on an annualized basis.
cient evidence to establish the surety (c) Computation of 15 percent: An HHA
company’s liability on the bond, the that seeks to become a participating HHA
surety company fails to timely pay by obtaining assets or ownership interest.

CMS in full the amount requested, up For an HHA that seeks to become a
to the face amount of the bond; or participating HHA by purchasing the
600
assets or the ownership interest of a (1) The full amount of any unpaid
participating or formerly participating claim, plus accrued interest, for which
HHA, the 15 percent is computed on the the HHA is responsible; and
basis of Medicare payments made by (2) The full amount of any unpaid
CMS to the participating or formerly civil money penalty or assessment im-
participating HHA in the most recent posed by CMS on the HHA, plus ac-
fiscal year that a cost report has been crued interest.
accepted. (b) The bond must provide the fol-
(d) Change of ownership. For an HHA lowing:
that undergoes a change of ownership (1) The Surety is liable for unpaid
the 15 percent is computed on the basis claims, unpaid civil money penalties,
of Medicare payments made by CMS to and unpaid assessments that are dis-
the HHA for the most recently accept- covered when the surety bond is in ef-
ed cost report. fect, regardless of when the payment,
(e) An HHA that seeks to become a par- overpayment, or other event giving
ticipating HHA without obtaining assets rise to the claim, civil money penalty,
or ownership interest. For an HHA that or assessment occurred, provided CMS
seeks to become a participating HHA makes a written demand for payment
without purchasing the assets or the from the Surety during, or within 90
ownership interest of a participating or days after, the term of the bond.
formerly participating HHA, the 15 per- (2) If the HHA fails to furnish a bond
cent computation does not apply. meeting the requirements of this sub-
(f) Exception to the basic rule. If an part F for the year following expiration
HHA’s overpayment in the most re- of the term of an annual bond, or if the
cently accepted cost report exceeds 15 HHA fails to submit a rider when a
percent of annual payments, CMS may rider is required to be submitted under
require the HHA to secure a bond in an this subpart, or if the HHA’s provider
amount up to or equal to the amount agreement is terminated, the last bond
of overpayment, provided the amount or rider, as applicable, submitted by
of the bond is not less than $50,000. the HHA to CMS, which bond or appli-
(g) Expiration of the 15 percent provi- cable rider meets the requirements of
sion. For an annual surety bond, or for this subpart, remains effective and the
a rider on a continuous surety bond, Surety remains liable for unpaid
that is required to be submitted on or claims, civil money penalties, and as-
after June 1, 2005, notwithstanding any sessments that—
reference in this subpart to 15 percent (i) CMS determines or imposes on or
as a basis for determining the amount asserts against the HHA based on over-
of the bond, the amount of the bond or payments or other events that took
rider, as applicable, must be $50,000 or place during or prior to the term of the
such amount as CMS specifies in ac- last bond or rider; and
cordance with paragraph (f) of this sec- (ii) Were determined or imposed dur-
tion, whichever amount is greater. ing the 2 years following the date the
[63 FR 313, Jan. 5, 1998, as amended at 63 FR HHA failed to submit a bond or re-
29655, June 1, 1998] quired rider or the date the HHA’s pro-
vider agreement is terminated, which-
§ 489.66 Additional requirements of ever is later.
the surety bond. (c) The bond must provide that the
The surety bond that an HHA obtains Surety’s liability to CMS under the
under this subpart must meet the fol- bond is not extinguished by any action
lowing additional requirements: of the HHA, the Surety, or CMS, in-
(a) The bond must guarantee that cluding but not necessarily limited to
within 30 days of receiving written no- any of the following actions:
tice from CMS of an unpaid claim or (1) Action by the HHA or the Surety
unpaid civil money penalty or assess- to terminate or limit the scope or term
ment, which notice contains sufficient of the bond. The Surety’s liability may
evidence to establish the Surety’s li- be extinguished, however, when—
ability under the bond, the Surety will (i) The Surety furnishes CMS with
pay CMS, up to the stated amount of notice of such action not later than 10
the bond— days after receiving notice from the
601
§ 489.67 42 CFR Ch. IV (10–1–17 Edition)
HHA of action by the HHA to termi- annual bond is submitted for the initial
nate or limit the scope of the bond, or term, it must be effective through the
not later than 60 days before the effec- end of the HHA’s current fiscal year.
tive date of such action by the Surety; (b) Type of bond. The type of bond re-
or quired to be submitted by an HHA
(ii) The HHA furnishes CMS with a under this subpart may be either—
new bond that meets the requirements (1) An annual bond (that is, a bond
of this subpart. that specifies an effective annual pe-
(2) The Surety’s failure to continue riod corresponding to the HHA’s fiscal
to meet the requirements of § 489.64(a) year); or
or CMS’s determination that the sur- (2) A continuous bond (that is, a bond
ety company is an unauthorized Surety that remains in full force and effect
under § 489.64(b). from term to term unless it is termi-
(3) Termination of the HHA’s pro- nated or canceled as provided for in the
vider agreement. bond or as otherwise provided by law)
(4) Any action by CMS to suspend, that is updated by the Surety, via the
offset, or otherwise recover payments issuance of a rider, for a particular fis-
to the HHA. cal year for which the bond amount has
(5) Any action by the HHA to— changed or will change.
(i) Cease operation; (c) HHA that seeks to become a partici-
(ii) Sell or transfer any asset or own- pating HHA. (1) An HHA that seeks to
ership interest; become a participating HHA must sub-
(iii) File for bankruptcy; or mit a surety bond with its enrollment
(iv) Fail to pay the Surety. application (Form CMS–855, OMB num-
(6) Any fraud, misrepresentation, or ber 0938–0685). The term of the initial
negligence by the HHA in obtaining the surety bond must be effective from the
surety bond or by the Surety (or by the effective date of provider agreement as
Surety’s agent, if any) in issuing the specified in § 489.13 of this part. How-
surety bond, except that any fraud, ever, if the effective date of the pro-
misrepresentation, or negligence by vider agreement is less than 30 days be-
the HHA in identifying to the Surety fore the end of the HHA’s current fiscal
(or to the Surety’s agent) the amount year, the HHA may obtain a bond effec-
of Medicare payments upon which the tive through the end of the next fiscal
amount of the surety bond is deter- year, provided the amount of the bond
mined will not cause the Surety’s li- is the greater of $75,000 or 20 percent of
ability to CMS to exceed the amount of the amount determined from the com-
the bond. putation specified in § 489.65(c) as appli-
(7) The HHA’s failure to exercise cable.
available appeal rights under Medicare (2) An HHA that seeks to become a
or to assign such rights to the Surety. participating HHA through the pur-
(d) The bond must provide that ac- chase or transfer of assets or ownership
tions under the bond may be brought interest of a participating or formerly
by CMS or by CMS’s fiscal inter- participating HHA must also ensure
mediaries. that the surety bond is effective from
(e) The bond must provide the Sure- the date of such purchase or transfer.
ty’s name, street address or post office (d) Change of ownership. An HHA that
box number, city, state, and zipcode to undergoes a change of ownership must
which the CMS notice provided for in submit the surety bond to CMS not
paragraph (a) of this section is to be later than the effective date of the
sent. change of ownership and the bond must
[63 FR 313, Jan. 5, 1998, as amended at 63 FR be effective from the effective date of
29655, June 1, 1998] the change of ownership through the
remainder of the HHA’s fiscal year.
§ 489.67 Term and type of bond. (e) Government-operated HHA that
(a) Each participating HHA that does loses its waiver. A government-operated
not meet the criteria for waiver under HHA that, as of January 1, 1998, meets
§ 489.62 must submit to CMS in a form the criteria for waiver under § 489.62
as CMS may specify, a surety bond for but thereafter is determined by CMS to
a term beginning January 1, 1998. If an not meet such criteria, must submit a
602
surety bond to CMS within 60 days § 489.70 Effect of payment by the Sur-
after it receives notice from CMS that ety.
it no longer meets the criteria for A Surety’s payment to CMS under a
waiver. bond for an unpaid claim or an unpaid
(f) Change of Surety. An HHA that ob- civil money penalty or assessment,
tains a replacement surety bond from a constitutes—
different Surety to cover the remaining (a) Collection of the unpaid claim or
term of a previously obtained bond unpaid civil money penalty or assess-
must submit the new surety bond to ment (to the extent the Surety’s pay-
CMS within 30 days of obtaining the ment on the bond covers such unpaid
bond from the new Surety. claim, civil money penalty, or assess-
(Authority: Secs. 1102 and 1871 of the Social ment); and
Security Act (42 U.S.C. 1302 and 1395hh)) (b) A basis for termination of the
[63 FR 315, Jan. 5, 1998, as amended at 63 FR HHA’s provider agreement under
10731, Mar. 4, 1998; 63 FR 29656, June 1, 1998; § 489.53(a)(1).
63 FR 41171, July 31, 1998]
§ 489.71 Surety’s standing to appeal
§ 489.68 Effect of failure to obtain, Medicare determinations.
maintain, and timely file a surety A Surety has standing to appeal any
bond. matter that the HHA could appeal, pro-
(a) The failure of a participating vided the Surety satisfies all jurisdic-
HHA to obtain, file timely, and main- tional and procedural requirements
tain a surety bond in accordance with that would otherwise have applied to
this subpart F and CMS’s instructions the HHA, and provided the HHA is not,
is sufficient under § 489.53(a)(1) for CMS itself, actively pursuing its appeal
to terminate the HHA’s provider agree- rights under this chapter, and provided
ment. further that, with respect to unpaid
(b) The failure of an HHA seeking to claims, the Surety has paid CMS all
become a participating HHA to obtain amounts owed to CMS by the HHA on
and file timely a surety bond in accord- such unpaid claims, up to the amount
ance with this Subpart F and CMS’s in- of the bond.
structions is sufficient under [63 FR 29656, June 1, 1998]
§ 489.12(a)(3) for CMS to refuse to enter
into a provider agreement with the § 489.72 Effect of review reversing de-
HHA. termination.
§ 489.69 Evidence of compliance. In the event a Surety has paid CMS
on the basis of liability incurred under
(a) CMS may at any time require an a bond obtained by an HHA under this
HHA to make a specific showing of subpart F, and to the extent the HHA
being in compliance with the require- that obtained such bond (or the Surety
ments of this Subpart F and may re- under § 489.71) is subsequently success-
quire the HHA to submit such addi- ful in appealing the determination that
tional evidence as CMS considers suffi- was the basis of the unpaid claim or
cient to demonstrate the HHA’s com- unpaid civil money penalty or assess-
pliance. ment that caused the Surety to pay
(b) If requested by CMS to do so, the CMS under the bond, CMS will refund
failure of an HHA to timely furnish to the Surety the amount the Surety
sufficient evidence to CMS to dem- paid to CMS to the extent such amount
onstrate compliance with the require- relates to the matter that was success-
ments of this Subpart F is sufficient fully appealed by the HHA (or by the
for CMS to terminate the HHA’s pro- Surety), provided all review, including
vider agreement under § 489.53(a)(1) or judicial review, has been completed on
to refuse to enter into a provider agree- such matter. Any additional amounts
ment with the HHA under § 489.12(a)(3), owing as a result of the appeal will be
as applicable. paid to the HHA.
603
§ 489.73 42 CFR Ch. IV (10–1–17 Edition)
§ 489.73 Effect of conditions of pay- rectives with respect to all adult indi-
ment. viduals receiving medical care, or pa-
If a Surety has paid an amount to tient care in the case of a patient in a
CMS on the basis of liability incurred religious nonmedical health care insti-
under a bond obtained by an HHA tution, by or through the provider and
under this subpart F, and CMS subse- are required to:
quently collects from the HHA, in (1) Provide written information to
whole or in part, on such unpaid claim, such individuals concerning—
civil money penalty, or assessment (i) An individual’s rights under State
that was the basis for the Surety’s li- law (whether statutory or recognized
ability, CMS reimburses the Surety by the courts of the State) to make de-
such amount as CMS collected from cisions concerning such medical care,
the HHA, up to the amount paid by the including the right to accept or refuse
Surety to CMS, provided the Surety medical or surgical treatment and the
has no other liability to CMS under the right to formulate, at the individual’s
bond. option, advance directives. Providers
are permitted to contract with other
(Authority: Secs. 1102 and 1871 of the Social entities to furnish this information but
Security Act (42 U.S.C. 1302 and 1395hh)) are still legally responsible for ensur-
[63 FR 29656, June 1, 1998] ing that the requirements of this sec-
tion are met. Providers are to update
§ 489.74 Incorporation into existing and disseminate amended information
provider agreements. as soon as possible, but no later than 90
The requirements of this subpart F days from the effective date of the
are deemed to be incorporated into ex- changes to State law; and
isting HHA provider agreements effec- (ii) The written policies of the pro-
tive January 1, 1998. vider or organization respecting the
[63 FR 315, Jan. 5, 1998. Redesignated at 63 FR implementation of such rights, includ-
29656, June 1, 1998] ing a clear and precise statement of
limitation if the provider cannot im-
plement an advance directive on the
Subparts G–H [Reserved] basis of conscience. At a minimum, a
provider’s statement of limitation
Subpart I—Advance Directives should:
(A) Clarify any differences between
SOURCE: 57 FR 8203, Mar. 6, 1992, unless oth- institution-wide conscience objections
erwise noted. and those that may be raised by indi-
vidual physicians;
§ 489.100 Definition. (B) Identify the state legal authority
For purposes of this part, advance di- permitting such objection; and
rective means a written instruction, (C) Describe the range of medical
such as a living will or durable power conditions or procedures affected by
of attorney for health care, recognized the conscience objection.
under State law (whether statutory or (2) Document in a prominent part of
as recognized by the courts of the the individual’s current medical
State), relating to the provision of record, or patient care record in the
health care when the individual is inca- case of an individual in a religious non-
pacitated. medical health care institution, wheth-
er or not the individual has executed
§ 489.102 Requirements for providers. an advance directive;
(a) Hospitals, critical access hos- (3) Not condition the provision of
pitals, skilled nursing facilities, nurs- care or otherwise discriminate against
ing facilities, home health agencies, an individual based on whether or not
providers of home health care (and for the individual has executed an advance
Medicaid purposes, providers of per- directive;
sonal care services), hospices, and reli- (4) Ensure compliance with require-
gious nonmedical health care institu- ments of State law (whether statutory
tions must maintain written policies or recognized by the courts of the
and procedures concerning advance di- State) regarding advance directives.
604
The provider must inform individuals (c) The providers listed in paragraph
that complaints concerning the ad- (a) of this section—
vance directive requirements may be (1) Are not required to provide care
filed with the State survey and certifi- that conflicts with an advance direc-
cation agency; tive.
(5) Provide for education of staff con- (2) Are not required to implement an
cerning its policies and procedures on advance directive if, as a matter of
advance directives; and conscience, the provider cannot imple-
(6) Provide for community education ment an advance directive and State
regarding issues concerning advance law allows any health care provider or
directives that may include material any agent of such provider to conscien-
required in paragraph (a)(1) of this sec- tiously object.
tion, either directly or in concert with
(d) Prepaid or eligible organizations
other providers and organizations. Sep-
(as specified in sections 1833(a)(1)(A)
arate community education materials
may be developed and used, at the dis- and 1876(b) of the Act) must meet the
cretion of providers. The same written requirements specified in § 417.436 of
materials do not have to be provided in this chapter.
all settings, but the material should (e) If an adult individual is incapaci-
define what constitutes an advance di- tated at the time of admission or at
rective, emphasizing that an advance the start of care and is unable to re-
directive is designed to enhance an in- ceive information (due to the incapaci-
capacitated individual’s control over tating conditions or a mental disorder)
medical treatment, and describe appli- or articulate whether or not he or she
cable State law concerning advance di- has executed an advance directive,
rectives. A provider must be able to then the provider may give advance di-
document its community education ef- rective information to the individual’s
forts. family or surrogate in the same man-
(b) The information specified in para- ner that it issues other materials about
graph (a) of this section is furnished: policies and procedures to the family of
(1) In the case of a hospital, at the the incapacitated individual or to a
time of the individual’s admission as surrogate or other concerned persons
an inpatient. in accordance with State law. The pro-
(2) In the case of a skilled nursing fa- vider is not relieved of its obligation to
cility at the time of the individual’s provide this information to the indi-
admission as a resident. vidual once he or she is no longer inca-
(3)(i) In the case of a home health pacitated or unable to receive such in-
agency, in advance of the individual formation. Follow-up procedures must
coming under the care of the agency. be in place to provide the information
The HHA may furnish advance direc- to the individual directly at the appro-
tives information to a patient at the priate time.
time of the first home visit, as long as
the information is furnished before [57 FR 8203, Mar. 6, 1992, as amended at 59 FR
care is provided. 45403, Sept. 1, 1994; 60 FR 33294, June 27, 1995;
(ii) In the case of personal care serv- 62 FR 46037, Aug. 29, 1997; 64 FR 67052, Nov. 30,
ices, in advance of the individual com- 1999; 68 FR 66720, Nov. 28, 2003]
ing under the care of the personal care
§ 489.104 Effective dates.
services provider. The personal care
provider may furnish advance direc- These provisions apply to services
tives information to a patient at the furnished on or after December 1, 1991
time of the first home visit, as long as payments made under section
the information is furnished before 1833(a)(1)(A) of the Act on or after De-
care is provided. cember 1, 1991, and contracts effective
(4) In the case of a hospice program, on or after December 1, 1991.
at the time of initial receipt of hospice

care by the individual from the pro-
gram.
605
PART 491—CERTIFICATION OF tional Board of Pediatric Nurse Practi-

CERTAIN HEALTH FACILITIES tioners and Associates; or
(2) Has satisfactorily completed a
Subpart A—Rural Health Clinics: Conditions formal 1 academic year educational
for Certification; and FQHCs Conditions program that:
for Coverage (i) Prepares registered nurses to per-
form an expanded role in the delivery
Sec. of primary care;
491.1 Purpose and scope. (ii) Includes at least 4 months (in the
491.2 Definitions. aggregate) of classroom instruction
491.3 Certification procedures.
and a component of supervised clinical
491.4 Compliance with Federal, State and
local laws.
practice; and
491.5 Location of clinic. (iii) Awards a degree, diploma, or cer-
491.6 Physical plant and environment. tificate to persons who successfully
491.7 Organizational structure. complete the program; or
491.8 Staffing and staff responsibilities. (3) Has successfully completed a for-
491.9 Provision of services. mal educational program (for pre-
491.10 Patient health records. paring registered nurses to perform an
491.11 Program evaluation. expanded role in the delivery of pri-
491.12 Emergency preparedness.
mary care) that does not meet the re-
AUTHORITY: Sec. 1102 of the Social Security quirements of paragraph (2) of this def-
Act (42 U.S.C. 1302); and sec. 353 of the Public inition, and has been performing an ex-
Health Service Act (42 U.S.C. 263a). panded role in the delivery of primary
care for a total of 12 months during the
Subpart A—Rural Health Clinics: 18-month period immediately preceding
Conditions for Certification; the effective date of this subpart.
and FQHCs Conditions for Physician means the following:
Coverage (1) As it pertains to the supervision,
collaboration, and oversight require-
§ 491.1 Purpose and scope. ments in sections 1861(aa)(2)(B) and
This subpart sets forth the condi- (aa)(3) of the Act, a doctor of medicine
tions that rural health clinics or or osteopathy legally authorized to
FQHCs must meet in order to qualify practice medicine or surgery in the
for reimbursement under Medicare State in which the function is per-
(title XVIII of the Social Security Act) formed; and
and that rural health clinics must (2) Within limitations as to the spe-
meet in order to qualify for reimburse- cific services furnished, a doctor of
ment under Medicaid (title XIX of the dental surgery or of dental medicine, a
Act). doctor of optometry, a doctor of podia-
try or surgical chiropody or a chiro-
[57 FR 24982, June 12, 1992] practor (see section 1861(r) of the Act
for specific limitations).
§ 491.2 Definitions. Physician assistant means a person
As used in this subpart, unless the who meets the applicable State re-
context indicates otherwise: quirements governing the qualifica-
Direct services means services pro- tions for assistants to primary care
vided by the clinic’s staff. physicians, and who meets at least one
FQHC means an entity as defined in of the following conditions:
§ 405.2401(b). (1) Is currently certified by the Na-
Nurse practitioner means a registered tional Commission on Certification of
professional nurse who is currently li- Physician Assistants to assist primary
censed to practice in the State, who care physicians; or
meets the State’s requirements gov- (2) Has satisfactorily completed a
erning the qualifications of nurse prac- program for preparing physician’s as-
titioners, and who meets one of the fol- sistants that:
lowing conditions: (i) Was at least 1 academic year in
(1) Is currently certified as a primary length;

care nurse practitioner by the Amer- (ii) Consisted of supervised clinical
ican Nurses’ Association or by the Na- practice and at least 4 months (in the
606
aggregate) of classroom instruction di- cable Federal, State and local laws and
rected toward preparing students to de- regulations.
liver health care; and (a) Licensure of clinic or center. The
(iii) Was accredited by the American clinic or center is licensed pursuant to
Medical Association’s Committee on applicable State and local law.
Allied Health Education and Accredita- (b) Licensure, certification or registra-
tion; or tion of personnel. Staff of the clinic or
(3) Has satisfactorily completed a center are licensed, certified or reg-
formal educational program (for pre- istered in accordance with applicable
paring physician assistants) that does State and local laws.
not meet the requirements of para- [57 FR 24982, June 12, 1992]
graph (2) of this definition and assisted
primary care physicians for a total of § 491.5 Location of clinic.
12 months during the 18-month period (a) Basic requirements. (1) An RHC is
that ended on December 31, 1986. located in a rural area that is des-
Rural area means an area that is not ignated as a shortage area.
delineated as an urbanized area by the (2) An FQHC is located in a rural or
Bureau of the Census. urban area that is designated as either
Rural health clinic or clinic means a a shortage area or an area that has a
clinic that is located in a rural area medically underserved population.
designated as a shortage area, is not a (3) Both the RHC and the FQHC may
rehabilitation agency or a facility pri- be permanent or mobile units.
marily for the care and treatment of (i) Permanent unit. The objects, equip-
mental diseases, and meets all other ment, and supplies necessary for the
requirements of this subpart. provision of the services furnished di-
Shortage area means a defined geo- rectly by the clinic or center are
graphic area designated by the Depart- housed in a permanent structure.
ment as having either a shortage of (ii) Mobile unit. The objects, equip-
personal health services (under section ment, and supplies necessary for the
1302(7) of the Public Health Service provision of the services furnished di-
Act) or a shortage of primary medical rectly by the clinic or center are
care manpower (under section 332 of housed in a mobile structure, which
that Act). has fixed, scheduled location(s).
Secretary means the Secretary of (iii) Permanent unit in more than one
Health and Human Services, or any of- location. If clinic or center services are
ficial to whom he has delegated the furnished at permanent units in more
pertinent authority. than one location, each unit is inde-
pendently considered for approval as a
FR 27156, May 12, 2014] rural health clinic or for approval as an
FQHC.
§ 491.3 Certification procedures. (b) Exceptions. (1) CMS does not dis-
qualify an RHC approved under this
A rural health clinic will be certified
subpart if the area in which it is lo-
for participation in Medicare in accord-
cated subsequently fails to meet the
ance with subpart S of 42 CFR part 405.
definition of a rural, shortage area.
The Secretary will notify the State
(2) A private, nonprofit facility that
Medicaid agency whenever he has cer-
meets all other conditions of this sub-
tified or denied certification under
part except for location in a shortage
Medicare for a prospective rural health
area will be certified if, on July 1, 1977,
clinic in that State. A clinic certified
it was operating in a rural area that is
under Medicare will be deemed to meet
determined by the Secretary (on the
the standards for certification under
basis of the ratio of primary care phy-
Medicaid.
sicians to the general population) to
[71 FR 55346, Sept. 22, 2006] have an insufficient supply of physi-
cians to meet the needs of the area
§ 491.4 Compliance with Federal, State served.
and local laws. (3) Determinations on these excep-

The rural health clinic or FQHC and tions will be made by the Secretary
its staff are in compliance with appli- upon application by the facility.
607
§ 491.6 42 CFR Ch. IV (10–1–17 Edition)
(c) Criteria for designation of rural (2) A population group that is des-
areas. (1) Rural areas are areas not de- ignated by PHS as having a shortage of
lineated as urbanized areas in the last personal health services.
census conducted by the Census Bu- (f) Requirements specific to FQHCs. An
reau. FQHC approved for participation in
(2) Excluded from the rural area clas- Medicare must meet one of the fol-
sification are: lowing criteria:
(i) Central cities of 50,000 inhabitants (1) Furnish services to a medically
or more; underserved population.
(ii) Cities with at least 25,000 inhab- (2) Be located in a medically under-
itants which, together with contiguous served area, as demonstrated by an ap-
areas having stipulated population den- plication approved by PHS.
sity, have combined populations of CROSS REFERENCE: See 42 CFR 110.203(g) (41
50,000 and constitute, for general eco- FR 45718, Oct. 15, 1976) and 42 CFR Part 5 (42
nomic and social purposes, single com- FR 1586, Jan. 10, 1978).
munities;
[43 FR 5375, Feb. 8, 1978. Redesignated at 50
(iii) Closely settled territories sur- FR 33034, Aug. 16, 1985, and amended at 57 FR
rounding cities and specifically des- 24982, June 12, 1992; 61 FR 14658, Apr. 3, 1996;
ignated by the Census Bureau as urban. 68 FR 74816, Dec. 24, 2003; 71 FR 55346, Sept.
(3) Included in the rural area classi- 22, 2006]
fication are those portions of extended
cities that the Census Bureau has de- § 491.6 Physical plant and environ-
termined to be rural. ment.
(d) Criteria for designation of shortage (a) Construction. The clinic or center
areas. (1) The criteria for determina- is constructed, arranged, and main-
tion of shortage of personal health tained to insure access to and safety of
services (under section 1302(7) of the patients, and provides adequate space
Public Health Services Act), are: for the provision of direct services.
(i) The ratio of primary care physi- (b) Maintenance. The clinic or center
cians practicing within the area to the has a preventive maintenance program
resident population; to ensure that:
(ii) The infant mortality rate; (1) All essential mechanical, elec-
(iii) The percent of the population 65 trical and patient-care equipment is
years of age or older; and maintained in safe operating condition;
(iv) The percent of the population (2) Drugs and biologicals are appro-
with a family income below the pov- priately stored; and
erty level. (3) The premises are clean and or-
(2) The criteria for determination of derly.
shortage of primary medical care man- [57 FR 24983, June 12, 1992, as amended at 81
power (under section 332(a)(1)(A) of the FR 64041, Sept. 16, 2016]
Public Health Services Act) are:
(i) The area served is a rational area § 491.7 Organizational structure.
for the delivery of primary medical (a) Basic requirements. (1) The clinic
care services; or center is under the medical direc-
(ii) The ratio of primary care physi- tion of a physician, and has a health
cians practicing within the area to the care staff that meets the requirements
resident population; and of § 491.8.
(iii) The primary medical care man- (2) The organization’s policies and its
power in contiguous areas is overuti- lines of authority and responsibilities
lized, excessively distant, or inacces- are clearly set forth in writing.
sible to the population in this area. (b) Disclosure. The clinic or center
(e) Medically underserved population. discloses the names and addresses of:
A medically underserved population in- (1) Its owners, in accordance with
cludes the following: section 1124 of the Social Security Act
(1) A population of an urban or rural (42 U.S.C. 132 A–3);
area that is designated by PHS as hav- (2) The person principally responsible
ing a shortage of personal health serv- for directing the operation of the clinic
ices. or center; and
608
(3) The person responsible for med- the clinic’s or center’s written policies
ical direction. and the services provided to Federal
[57 FR 24983, June 12, 1992]
program patients.
(3) Periodically reviews the clinic’s
§ 491.8 Staffing and staff responsibil- or center’s patient records, provides
ities. medical orders, and provides medical
(a) Staffing. (1) The clinic or center care services to the patients of the
has a health care staff that includes clinic or center.
one or more physicians. Rural health (c) Physician assistant and nurse prac-
clinic staffs must also include one or titioner responsibilities. (1) The physician
more physician’s assistants or nurse assistant and the nurse practitioner
practitioners. members of the clinic’s or center’s
(2) The physician member of the staff staff:
may be the owner of the rural health (i) Participate in the development,
clinic, an employee of the clinic or cen- execution and periodic review of the
ter, or under agreement with the clinic written policies governing the services
or center to carry out the responsibil- the clinic or center furnishes;
ities required under this section. (ii) Participate with a physician in a
(3) The physician assistant, nurse periodic review of the patients’ health
practitioner, nurse-midwife, clinical records.
social worker or clinical psychologist (2) The physician assistant or nurse
member of the staff may be the owner practitioner performs the following
or an employee of the clinic or center, functions, to the extent they are not
or may furnish services under contract being performed by a physician:
to the clinic or center. In the case of a (i) Provides services in accordance
clinic, at least one physician assistant with the clinic’s or center’s policies;
or nurse practitioner must be an em- (ii) Arranges for, or refers patients
ployee of the clinic. to, needed services that cannot be pro-
(4) The staff may also include ancil- vided at the clinic or center; and
lary personnel who are supervised by (iii) Assures that adequate patient
the professional staff. health records are maintained and
(5) The staff is sufficient to provide transferred as required when patients
the services essential to the operation are referred.
of the clinic or center. [57 FR 24983, June 12, 1992, as amended at 61
(6) A physician, nurse practitioner, FR 14658, Apr. 3, 1996; 68 FR 74817, Dec. 24,
physician assistant, certified nurse- 2003; 71 FR 55346, Sept. 22, 2006; 79 FR 25480,
midwife, clinical social worker, or clin- May 2, 2014; 79 FR 27156, May 12, 2014]
ical psychologist is available to furnish
patient care services at all times the § 491.9 Provision of services.
clinic or center operates. In addition, (a) Basic requirements. (1) All services
for RHCs, a nurse practitioner, physi- offered by the clinic or center are fur-
cian assistant, or certified nurse-mid- nished in accordance with applicable
wife is available to furnish patient care Federal, State, and local laws; and
services at least 50 percent of the time (2) The clinic or center is primarily
the RHC operates. engaged in providing outpatient health
(b) Physician responsibilities. The phy- services and meets all other conditions
sician performs the following: of this subpart.
(1) Except for services furnished by a (3) The laboratory requirements in
clinical psychologist in an FQHC, paragraph (c)(2) of this section apply to
which State law permits to be provided RHCs, but do not apply to FQHCs.
without physician supervision, pro- (b) Patient care policies. (1) The clin-
vides medical direction for the clinic’s ic’s or center’s health care services are
or center’s health care activities and furnished in accordance with appro-
consultation for, and medical super- priate written policies which are con-
vision of, the health care staff. sistent with applicable State law.
(2) In conjunction with the physician (2) The policies are developed with
assistant and/or nurse practitioner the advice of a group of professional

member(s), participates in developing, personnel that includes one or more
executing, and periodically reviewing physicians and one or more physician
609
§ 491.10 42 CFR Ch. IV (10–1–17 Edition)
assistants or nurse practitioners. At and has available the drugs and

least one member is not a member of biologicals commonly used in life sav-
the clinic or center staff. ing procedures, such as analgesics, an-
(3) The policies include: esthetics (local), antibiotics,
(i) A description of the services the anticonvulsants, antidotes and
clinic or center furnishes directly and emetics, serums and toxoids.
those furnished through agreement or (d) Services provided through agree-
arrangement. ments or arrangements. (1) The clinic or
(ii) Guidelines for the medical man- center has agreements or arrangements
agement of health problems which in- with one or more providers or suppliers
clude the conditions requiring medical participating under Medicare or Med-
consultation and/or patient referral, icaid to furnish other services to its pa-
the maintenance of health care tients, including:
records, and procedures for the periodic (i) Inpatient hospital care;
review and evaluation of the services (ii) Physician(s) services (whether
furnished by the clinic or center. furnished in the hospital, the office,
(iii) Rules for the storage, handling, the patient’s home, a skilled nursing
and administration of drugs and facility, or elsewhere); and
biologicals. (iii) Additional and specialized diag-
(4) These policies are reviewed at nostic and laboratory services that are
least annually by the group of profes- not available at the clinic or center.
sional personnel required under para- (2) If the agreements are not in writ-
graph (b)(2) of this section and re- ing, there is evidence that patients re-
viewed as necessary by the clinic or ferred by the clinic or center are being
center. accepted and treated.
(c) Direct services—(1) General. The [57 FR 24983, June 12, 1992, as amended at 58
clinic or center staff furnishes those di- FR 63536, Dec. 2, 1993]
agnostic and therapeutic services and
supplies that are commonly furnished § 491.10 Patient health records.
in a physician’s office or at the entry (a) Records system. (1) The clinic or
point into the health care delivery sys- center maintains a clinical record sys-
tem. These include medical history, tem in accordance with written poli-
physical examination, assessment of cies and procedures.
health status, and treatment for a vari- (2) A designated member of the pro-
ety of medical conditions. fessional staff is responsible for main-
(2) Laboratory. These requirements taining the records and for insuring
apply to RHCs but not to FQHCs. The that they are completely and accu-
RHC provides laboratory services in ac- rately documented, readily accessible,
cordance with part 493 of this chapter, and systematically organized.
which implements the provisions of (3) For each patient receiving health
section 353 of the Public Health Service care services, the clinic or center
Act. The RHC provides basic labora- maintains a record that includes, as
tory services essential to the imme- applicable:
diate diagnosis and treatment of the (i) Identification and social data, evi-
patient, including: dence of consent forms, pertinent med-
(i) Chemical examinations of urine ical history, assessment of the health
by stick or tablet method or both (in- status and health care needs of the pa-
cluding urine ketones); tient, and a brief summary of the epi-
(ii) Hemoglobin or hematocrit; sode, disposition, and instructions to
(iii) Blood glucose; the patient;
(iv) Examination of stool specimens (ii) Reports of physical examinations,
for occult blood; diagnostic and laboratory test results,
(v) Pregnancy tests; and and consultative findings;
(vi) Primary culturing for trans- (iii) All physician’s orders, reports of
mittal to a certified laboratory. treatments and medications, and other
(3) Emergency. The clinic or center pertinent information necessary to
provides medical emergency procedures monitor the patient’s progress;

as a first response to common life- (iv) Signatures of the physician or
threatening injuries and acute illness other health care professional.
610
(b) Protection of record information. (1) meets the requirements of this section.
The clinic or center maintains the con- The emergency preparedness program
fidentiality of record information and must include, but not be limited to, the
provides safeguards against loss, de- following elements:
struction or unauthorized use. (a) Emergency plan. The RHC/FQHC
(2) Written policies and procedures must develop and maintain an emer-
govern the use and removal of records gency preparedness plan that must be
from the clinic or center and the condi- reviewed and updated at least annu-
tions for release of information. ally. The plan must do all of the fol-
(3) The patient’s written consent is lowing:
required for release of information not (1) Be based on and include a docu-
authorized to be released without such mented, facility-based and community-
consent. based risk assessment, utilizing an all-
(c) Retention of records. The records hazards approach.
are retained for at least 6 years from (2) Include strategies for addressing
date of last entry, and longer if re- emergency events identified by the
quired by State statute. risk assessment.
(Secs. 1102, 1833 and 1902(a)(13), Social Secu- (3) Address patient population, in-
rity Act; 49 Stat. 647, 91 Stat. 1485 (42 U.S.C. cluding, but not limited to, the type of
1302, 13951 and 1396a(a)(13))) services the RHC/FQHC has the ability
[43 FR 30529, July 14, 1978. Redesignated at 50 to provide in an emergency; and con-
FR 33034, Aug. 16, 1985, as amended at 57 FR tinuity of operations, including delega-
24984, June 12, 1992] tions of authority and succession
plans.
§ 491.11 Program evaluation.
(4) Include a process for cooperation
(a) The clinic or center carries out, and collaboration with local, tribal, re-
or arranges for, an annual evaluation gional, State, and Federal emergency
of its total program. preparedness officials’ efforts to main-
(b) The evaluation includes review of: tain an integrated response during a
(1) The utilization of clinic or center disaster or emergency situation, in-
services, including at least the number cluding documentation of the RHC/
of patients served and the volume of FQHC’s efforts to contact such officials
services; and, when applicable, of its participa-
(2) A representative sample of both tion in collaborative and cooperative
active and closed clinical records; and planning efforts.
(3) The clinic’s or center’s health (b) Policies and procedures. The RHC/
care policies. FQHC must develop and implement
(c) The purpose of the evaluation is emergency preparedness policies and
to determine whether: procedures, based on the emergency
(1) The utilization of services was ap- plan set forth in paragraph (a) of this
propriate; section, risk assessment at paragraph
(2) The established policies were fol- (a)(1) of this section, and the commu-
lowed; and nication plan at paragraph (c) of this
(3) Any changes are needed. section. The policies and procedures
(d) The clinic or center staff con- must be reviewed and updated at least
siders the findings of the evaluation annually. At a minimum, the policies
and takes corrective action if nec- and procedures must address the fol-
essary. lowing:
[71 FR 55346, Sept. 22, 2006] (1) Safe evacuation from the RHC/
FQHC, which includes appropriate
§ 491.12 Emergency preparedness. placement of exit signs; staff respon-
The Rural Health Clinic/Federally sibilities and needs of the patients.
Qualified Health Center (RHC/FQHC) (2) A means to shelter in place for pa-
must comply with all applicable Fed- tients, staff, and volunteers who re-
eral, State, and local emergency pre- main in the facility.
paredness requirements. The RHC/ (3) A system of medical documenta-

FQHC must establish and maintain an tion that preserves patient informa-
emergency preparedness program that tion, protects confidentiality of patient
611
§ 491.12 42 CFR Ch. IV (10–1–17 Edition)
information, and secures and main- reviewed and updated at least annu-
tains the availability of records. ally.
(4) The use of volunteers in an emer- (1) Training program. The RHC/FQHC
gency or other emergency staffing must do all of the following:
strategies, including the process and (i) Initial training in emergency pre-
role for integration of State and Feder- paredness policies and procedures to all
ally designated health care profes- new and existing staff, individuals pro-
sionals to address surge needs during viding services under arrangement, and
an emergency. volunteers, consistent with their ex-
(c) Communication plan. The RHC/ pected roles,
FQHC must develop and maintain an (ii) Provide emergency preparedness
emergency preparedness communica- training at least annually.
tion plan that complies with Federal, (iii) Maintain documentation of the
State, and local laws and must be retraining.
viewed and updated at least annually. (iv) Demonstrate staff knowledge of
The communication plan must include emergency procedures.
all of the following: (2) Testing. The RHC/FQHC must con-
(1) Names and contact information duct exercises to test the emergency
for the following: plan at least annually. The RHC/FQHC
(i) Staff. must do the following:
(ii) Entities providing services under (i) Participate in a full-scale exercise
arrangement. that is community-based or when a
(iii) Patients’ physicians. community-based exercise is not acces-
sible, an individual, facility-based. If
(iv) Other RHCs/FQHCs.
the RHC/FQHC experiences an actual
(v) Volunteers.
natural or man-made emergency that
(2) Contact information for the fol- requires activation of the emergency
lowing: plan, the RHC/FQHC is exempt from
(i) Federal, State, tribal, regional, engaging in a community-based or in-
and local emergency preparedness dividual, facility-based full-scale exer-
staff. cise for 1 year following the onset of
(ii) Other sources of assistance. the actual event.
(3) Primary and alternate means for (ii) Conduct an additional exercise
communicating with the following: that may include, but is not limited to
(i) RHC/FQHC’s staff. following:
(ii) Federal, State, tribal, regional, (A) A second full-scale exercise that
and local emergency management is community-based or individual, fa-
agencies. cility-based.
(4) A means of providing information (B) A tabletop exercise that includes
about the general condition and loca- a group discussion led by a facilitator,
tion of patients under the facility’s using a narrated, clinically-relevant
care as permitted under 45 CFR emergency scenario, and a set of prob-
164.510(b)(4). lem statements, directed messages, or
(5) A means of providing information prepared questions designed to chal-
about the RHC/FQHC’s needs, and its lenge an emergency plan.
ability to provide assistance, to the au- (iii) Analyze the RHC/FQHC’s re-
thority having jurisdiction or the Inci- sponse to and maintain documentation
dent Command Center, or designee. of all drills, tabletop exercises, and
(d) Training and testing. The RHC/ emergency events, and revise the RHC/
FQHC must develop and maintain an FQHC’s emergency plan, as needed.
emergency preparedness training and (e) Integrated healthcare systems. If a
testing program that is based on the RHC/FQHC is part of a healthcare sys-
emergency plan set forth in paragraph tem consisting of multiple separately
(a) of this section, risk assessment at certified healthcare facilities that
paragraph (a)(1) of this section, policies elects to have a unified and integrated
and procedures at paragraph (b) of this emergency preparedness program, the
section, and the communication plan RHC/FQHC may choose to participate

at paragraph (c) of this section. The in the healthcare system’s coordinated
training and testing program must be emergency preparedness program. If
612
elected, the unified and integrated 493.25 Laboratories performing tests of high
emergency preparedness program must complexity.
Subpart B—Certificate of Waiver
(1) Demonstrate that each separately
certified facility within the system ac- 493.35 Application for a certificate of waiv-
tively participated in the development er.
of the unified and integrated emer- 493.37 Requirements for a certificate of
gency preparedness program. waiver.
493.39 Notification requirements for labora-
(2) Be developed and maintained in a
tories issued a certificate of waiver.
manner that takes into account each
separately certified facility’s unique Subpart C—Registration Certificate, Certifi-
circumstances, patient populations, cate for Provider-performed Micros-
and services offered. copy Procedures, and Certificate of
(3) Demonstrate that each separately Compliance
certified facility is capable of actively
using the unified and integrated emer- 493.43 Application for registration certifi-
gency preparedness program and is in cate, certificate for provider-performed
microscopy (PPM) procedures, and cer-
compliance with the program.
tificate of compliance.
(4) Include a unified and integrated 493.45 Requirements for a registration cer-
emergency plan that meets the require- tificate.
ments of paragraphs (a)(2), (3), and (4) 493.47 Requirements for a certificate for
of this section. The unified and inte- provider-performed microscopy (PPM)
grated emergency plan must also be procedures.
based on and include all of the fol- 493.49 Requirements for a certificate of
lowing: compliance.
493.51 Notification requirements for labora-
(i) A documented community–based
tories issued a certificate of compliance.
risk assessment, utilizing an all-haz- 493.53 Notification requirements for labora-
ards approach. tories issued a certificate for provider-
(ii) A documented individual facility- performed microscopy (PPM) procedures.
based risk assessment for each sepa-
rately certified facility within the Subpart D—Certificate of Accreditation
health system, utilizing an all-hazards 493.55 Application for registration certifi-
approach. cate and certificate of accreditation.
(5) Include integrated policies and 493.57 Requirements for a registration cer-
procedures that meet the requirements tificate.
set forth in paragraph (b) of this sec- 493.61 Requirements for a certificate of ac-
tion, a coordinated communication creditation.
plan, and training and testing pro- 493.63 Notification requirements for labora-
grams that meet the requirements of tories issued a certificate of accredita-
tion.
paragraphs (c) and (d) of this section,
respectively. Subpart E—Accreditation by a Private,
[81 FR 64041, Sept. 16, 2016] Nonprofit Accreditation Organization
or Exemption Under an Approved
PART 493—LABORATORY State Laboratory Program
REQUIREMENTS 493.551 General requirements for labora-
tories.
Subpart A—General Provisions 493.553 Approval process (application and
reapplication) for accreditation organiza-
Sec. tions and State licensure programs.
493.1 Basis and scope. 493.555 Federal review of laboratory require-
493.2 Definitions. ments.
493.3 Applicability. 493.557 Additional submission requirements.
493.5 Categories of tests by complexity. 493.559 Publication of approval of deeming
493.15 Laboratories performing waived authority or CLIA exemption.
tests. 493.561 Denial of application or reapplica-
493.17 Test categorization. tion.
493.19 Provider-performed microscopy 493.563 Validation inspections—Basis and

(PPM) procedures. focus.
493.20 Laboratories performing tests of 493.565 Selection for validation inspection—
moderate complexity. laboratory responsibilities.
613
493.567 Refusal to cooperate with validation 493.857 Condition: Immunohematology.
inspection. 493.859 Standard; ABO group and D (Rho)
493.569 Consequences of a finding of non- typing.
compliance as a result of a validation in- 493.861 Standard; Unexpected antibody de-
spection. tection.
493.571 Disclosure of accreditation, State 493.863 Standard; Compatibility testing.
and CMS validation inspection results. 493.865 Standard; Antibody identification.
493.573 Continuing Federal oversight of pri-
vate nonprofit accreditation organiza- Subpart I—Proficiency Testing Programs for
tions and approved State licensure pro- Nonwaived Testing
grams.
493.575 Removal of deeming authority or 493.901 Approval of proficiency testing pro-
CLIA exemption and final determination grams.
review. 493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing pro-
Subpart F—General Administration grams.
493.602 Scope of subpart. PROFICIENCY TESTING PROGRAMS BY

493.606 Applicability of subpart. SPECIALTY AND SUBSPECIALTY
493.638 Certificate fees.
493.909 Microbiology.
493.639 Fee for revised certificate.
493.911 Bacteriology.
493.643 Fee for determination of program
493.913 Mycobacteriology.
compliance.
493.915 Mycology.
493.645 Additional fee(s) applicable to ap-
493.917 Parasitology.
proved State laboratory programs and
493.919 Virology.
laboratories issued a certificate of ac-
493.921 Diagnostic immunology.
creditation, certificate of waiver, or cer- 493.923 Syphilis serology.
tificate for PPM procedures. 493.927 General immunology.
493.646 Payment of fees. 493.929 Chemistry.
493.649 Methodology for determining fee
493.931 Routine chemistry.
amount. 493.933 Endocrinology.
493.937 Toxicology.
Subpart G [Reserved] 493.941 Hematology (including routine he-
matology and coagulation).
Subpart H—Participation in Proficiency 493.945 Cytology; gynecologic examinations.
Testing for Laboratories Performing 493.959 Immunohematology.
Nonwaived Testing
Subpart J—Facility Administration for
493.801 Condition: Enrollment and testing of
samples.
Nonwaived Testing
493.803 Condition: Successful participation. 493.1100 Condition: Facility administration.
493.807 Condition: Reinstatement of labora- 493.1101 Standard: Facilities.
tories performing nonwaived testing. 493.1103 Standard: Requirements for trans-
fusion services.
PROFICIENCY TESTING BY SPECIALTY AND SUB-
493.1105 Standard: Retention requirements.
SPECIALTY FOR LABORATORIES PERFORMING
TESTS OF MODERATE COMPLEXITY (INCLUD-
ING THE SUBCATEGORY), HIGH COMPLEXITY,
Subpart K—Quality System for Nonwaived
OR ANY COMBINATION OF THESE TESTS Testing
493.821 Condition: Microbiology. 493.1200 Introduction.
493.823 Standard; Bacteriology. 493.1201 Condition: Bacteriology.
493.825 Standard; Mycobacteriology. 493.1202 Condition: Mycobacteriology.
493.827 Standard; Mycology. 493.1203 Condition: Mycology.
493.829 Standard; Parasitology. 493.1204 Condition: Parasitology.
493.831 Standard; Virology. 493.1205 Condition: Virology.
493.833 Condition: Diagnostic immunology. 493.1207 Condition: Syphilis serology.
493.835 Standard; Syphilis serology. 493.1208 Condition: General immunology.
493.837 Standard; General immunology. 493.1210 Condition: Routine chemistry.
493.839 Condition: Chemistry. 493.1211 Condition: Urinalysis.
493.841 Standard; Routine chemistry. 493.1212 Condition: Endocrinology.
493.843 Standard; Endocrinology. 493.1213 Condition: Toxicology.
493.845 Standard; Toxicology. 493.1215 Condition: Hematology.
493.849 Condition: Hematology. 493.1217 Condition: Immunohematology.
493.851 Standard; Hematology. 493.1219 Condition: Histopathology.

493.853 Condition: Pathology. 493.1220 Condition: Oral pathology.
493.855 Standard; Cytology: gynecologic ex- 493.1221 Condition: Cytology.
aminations. 493.1225 Condition: Clinical cytogenetics.
614
493.1226 Condition: Radiobioassay. Subpart L [Reserved]
493.1227 Condition: Histocompatibility.
Subpart M—Personnel for Nonwaived
GENERAL LABORATORY SYSTEMS
Testing
493.1230 Condition: General laboratory sys-
tems. 493.1351 General.
493.1231 Standard: Confidentiality of patient
LABORATORIES PERFORMING PROVIDER-
information.
493.1232 Standard: Specimen identification PERFORMED MICROSCOPY (PPM) PROCEDURES
and integrity. 493.1353 Scope.
493.1233 Standard: Complaint investiga- 493.1355 Condition: Laboratories performing
tions. PPM procedures; laboratory director.
493.1234 Standard: Communications. 493.1357 Standard; laboratory director quali-
493.1235 Standard: Personnel competency fications.
assessment policies. 493.1359 Standard; PPM laboratory director
493.1236 Standard: Evaluation of proficiency responsibilities.
testing performance. 493.1361 Condition: Laboratories performing
493.1239 Standard: General laboratory sys- PPM procedures; testing personnel.
tems quality assessment. 493.1363 Standard; PPM testing personnel
qualifications.
PREANALYTIC SYSTEMS 493.1365 Standard; PPM testing personnel
493.1240 Condition: Preanalytic systems. responsibilities.
493.1241 Standard: Test request.
493.1242 Standard: Specimen submission, LABORATORIES PERFORMING MODERATE
handling, and referral. COMPLEXITY TESTING
493.1249 Standard: Preanalytic systems 493.1403 Condition: Laboratories performing
quality assessment. moderate complexity testing; laboratory
director.
ANALYTIC SYSTEMS 493.1405 Standard; Laboratory director
493.1250 Condition: Analytic systems. qualifications.
493.1251 Standard: Procedure manual. 493.1406 Standard; Laboratory director
493.1252 Standard: Test systems, equipment, qualifications on or before February 28,
instruments, reagents, materials, and 1992.
supplies. 493.1407 Standard; Laboratory director re-
493.1253 Standard: Establishment and sponsibilities.
verification of performance specifica- 493.1409 Condition: Laboratories performing
tions. moderate complexity testing; technical
493.1254 Standard: Maintenance and func- consultant.
tion checks. 493.1411 Standard; Technical consultant
493.1255 Standard: Calibration and calibra- qualifications.
tion verification procedures. 493.1413 Standard; Technical consultant re-
493.1256 Standard: Control procedures. sponsibilities.
493.1261 Standard: Bacteriology. 493.1415 Condition: Laboratories performing
493.1262 Standard: Mycobacteriology. moderate complexity testing; clinical
493.1263 Standard: Mycology. consultant.
493.1264 Standard: Parasitology. 493.1417 Standard; Clinical consultant quali-
493.1265 Standard: Virology. fications.
493.1267 Standard: Routine chemistry. 493.1419 Standard; Clinical consultant re-
493.1269 Standard: Hematology. sponsibilities.
493.1271 Standard: Immunohematology. 493.1421 Condition: Laboratories performing
493.1273 Standard: Histopathology. moderate complexity testing; testing
493.1274 Standard: Cytology. personnel.
493.1276 Standard: Clinical cytogenetics. 493.1423 Standard; Testing personnel quali-
493.1278 Standard: Histocompatibility. fications.
493.1281 Standard: Comparison of test re- 493.1425 Standard; Testing personnel respon-
sults. sibilities.
493.1282 Standard: Corrective actions.
493.1283 Standard: Test records. LABORATORIES PERFORMING HIGH COMPLEXITY
493.1289 Standard: Analytic systems quality TESTING
assessment. 493.1441 Condition: Laboratories performing
high complexity testing; laboratory di-
POSTANALYTIC SYSTEMS
rector.
493.1290 Condition: Postanalytic systems. 493.1443 Standard; Laboratory director

493.1291 Standard: Test report. qualifications.
493.1299 Standard: Postanalytic systems 493.1445 Standard; Laboratory director re-
quality assessment. sponsibilities.
615
493.1447 Condition: Laboratories performing questing or issued a certificate of accred-
high complexity testing; technical super- itation.
visor.
493.1449 Standard; Technical supervisor Subpart R—Enforcement Procedures
qualifications.
493.1451 Standard; Technical supervisor re- 493.1800 Basis and scope.
sponsibilities. 493.1804 General considerations.
493.1453 Condition: Laboratories performing 493.1806 Available sanctions: All labora-
high complexity testing; clinical consult- tories.
ant. 493.1807 Additional sanctions: Laboratories
493.1455 Standard; Clinical consultant quali- that participate in Medicare.
fications. 493.1808 Adverse action on any type of CLIA
493.1457 Standard; Clinical consultant re- certificate: Effect on Medicare approval.
sponsibilities. 493.1809 Limitation on Medicaid payment.
493.1459 Condition: Laboratories performing 493.1810 Imposition and lifting of alter-
high complexity testing; general super- native sanctions.
visor. 493.1812 Action when deficiencies pose im-
493.1461 Standard; General supervisor quali- mediate jeopardy.
fications. 493.1814 Action when deficiencies are at the
493.1462 General supervisor qualifications condition level but do not pose imme-
on or before February 28, 1992. diate jeopardy.
493.1463 Standard; General supervisor re- 493.1816 Action when deficiencies are not at
sponsibilities. the condition level.
493.1467 Condition: Laboratories performing 493.1820 Ensuring timely correction of defi-
high complexity testing; cytology gen- ciencies.
eral supervisor. 493.1826 Suspension of part of Medicare pay-
493.1469 Standard; Cytology general super- ments.
visor qualifications. 493.1828 Suspension of all Medicare pay-
493.1471 Standard; Cytology general super- ments.
visor responsibilities. 493.1832 Directed plan of correction and di-
493.1481 Condition: Laboratories performing rected portion of a plan of correction.
high complexity testing; 493.1834 Civil money penalty.
cytotechnologist. 493.1836 State onsite monitoring.
493.1483 Standard; Cytotechnologist quali- 493.1838 Training and technical assistance
fications. for unsuccessful participation in pro-
493.1485 Standard; Cytotechnologist respon- ficiency testing.
sibilities. 493.1840 Suspension, limitation, or revoca-
493.1487 Condition: Laboratories performing tion of any type of CLIA certificate.
high complexity testing; testing per- 493.1842 Cancellation of Medicare approval.
sonnel. 493.1844 Appeals procedures.
493.1489 Standard; Testing personnel quali- 493.1846 Civil action.
fications. 493.1850 Laboratory registry.
493.1491 Technologist qualifications on or
before February 28, 1992. Subpart S [Reserved]
493.1495 Standard; Testing personnel respon-
sibilities. Subpart T—Consultations
Subparts N–P [Reserved] 493.2001 Establishment and function of the

Clinical Laboratory Improvement Advi-
Subpart Q—Inspection sory Committee.
AUTHORITY: Sec. 353 of the Public Health
493.1771 Condition: Inspection requirements
Service Act, secs. 1102, 1861(e), the sentence
applicable to all CLIA-certified and
following sections 1861(s)(11) through
CLIA-exempt laboratories.
1861(s)(16) of the Social Security Act (42
493.1773 Standard: Basic inspection require-
U.S.C. 263a, 1302, 1395x(e), the sentence fol-
ments for all laboratories issued a CLIA
lowing 1395x(s)(11) through 1395x(s)(16)), and
certificate and CLIA-exempt labora-
the Pub. L. 112–202 amendments to 42 U.S.C.
tories.
263a.
493.1775 Standard: Inspection of laboratories
issued a certificate of waiver or a certifi- SOURCE: 55 FR 9576, Mar. 14, 1990, unless
cate for provider-performed microscopy otherwise noted.
procedures.
493.1777 Standard: Inspection of laboratories
Subpart A—General Provisions
that have requested or have been issued

a certificate of compliance.
493.1780 Standard: Inspection of CLIA-ex- SOURCE: 57 FR 7139, Feb. 28, 1992, unless
empt laboratories or laboratories re- otherwise noted.
616
§ 493.1 Basis and scope. Adverse action means the imposition

of a principal or alternative sanction
This part sets forth the conditions
by CMS.
that all laboratories must meet to be ALJ stands for Administrative Law
certified to perform testing on human Judge.
specimens under the Clinical Labora- Alternative sanctions means sanctions
tory Improvement Amendments of 1988 that may be imposed in lieu of or in ad-
(CLIA). It implements sections 1861(e) dition to principal sanctions. The term
and (j), the sentence following section is synonymous with ‘‘intermediate
1861(s)(13), and 1902(a)(9) of the Social sanctions’’ as used in section 1846 of
Security Act, and section 353 of the the Act.
Public Health Service Act, as amended Analyte means a substance or con-
by section 2 of the Taking Essential stituent for which the laboratory con-
Steps for Testing Act of 2012. This part ducts testing.
applies to all laboratories as defined Approved accreditation organization for
under ‘‘laboratory’’ in § 493.2 of this laboratories means a private, nonprofit
part. This part also applies to labora- accreditation organization that has
tories seeking payment under the formally applied for and received
Medicare and Medicaid programs. The CMS’s approval based on the organiza-
requirements are the same for Medi- tion’s compliance with this part.
care approval as for CLIA certification. Approved State laboratory program
means a licensure or other regulatory
[57 FR 7139, Feb. 28, 1992, as amended at 79 program for laboratories in a State,
FR 25480, May 2, 2014]
the requirements of which are imposed
§ 493.2 Definitions. under State law, and the State labora-
tory program has received CMS ap-
As used in this part, unless the con- proval based on the State’s compliance
text indicates otherwise— with this part.
Accredited institution means a school Authorized person means an indi-
or program which— vidual authorized under State law to
(a) Admits as regular student only order tests or receive test results, or
persons having a certificate of gradua- both.
tion from a school providing secondary Calibration means a process of testing
education, or the recognized equivalent and adjusting an instrument or test
of such certificate; system to establish a correlation be-
(b) Is legally authorized within the tween the measurement response and
State to provide a program of edu- the concentration or amount of the
cation beyond secondary education; substance that is being measured by
(c) Provides an educational program the test procedure.
for which it awards a bachelor’s degree Calibration verification means the as-
or provides not less than a 2-year pro- saying of materials of known con-
centration in the same manner as pa-
gram which is acceptable toward such
tient samples to substantiate the in-
a degree, or provides an educational
strument or test system’s calibration
program for which it awards a master’s
throughout the reportable range for pa-
or doctoral degree;
tient test results.
(d) Is accredited by a nationally rec- Challenge means, for quantitative
ognized accrediting agency or associa- tests, an assessment of the amount of
tion. substance or analyte present or meas-
This definition includes any foreign ured in a sample. For qualitative tests,
institution of higher education that a challenge means the determination
HHS or its designee determines meets of the presence or the absence of an
substantially equivalent requirements. analyte, organism, or substance in a
Accredited laboratory means a labora- sample.
tory that has voluntarily applied for CLIA means the Clinical Laboratory
and been accredited by a private, non- Improvement Amendments of 1988.
profit accreditation organization ap- CLIA certificate means any of the fol-
proved by CMS in accordance with this lowing types of certificates issued by
part; CMS or its agent:
617
§ 493.2 42 CFR Ch. IV (10–1–17 Edition)
(1) Certificate of compliance means a proved by CMS in accordance with sub-

certificate issued to a laboratory after part E of this part.
an inspection that finds the laboratory Condition level deficiency means non-
to be in compliance with all applicable compliance with one or more condition
condition level requirements, or re- level requirements.
issued before the expiration date, pend- Condition level requirements means
ing an appeal, in accordance with any of the requirements identified as
§ 493.49, when an inspection has found ‘‘conditions’’ in subparts G through Q
the laboratory to be out of compliance of this part.
with one or more condition level re- Confirmatory testing means testing
quirements. performed by a second analytical pro-
(2) Certificate for provider-performed cedure that could be used to substan-
microscopy (PPM) procedures means a tiate or bring into question the result
certificate issued or reissued before the of an initial laboratory test.
expiration date, pending an appeal, in
Credible allegation of compliance
accordance with § 493.47, to a labora-
means a statement or documentation
tory in which a physician, midlevel
that—
practitioner or dentist performs no
(1) Is made by a representative of a
tests other than PPM procedures and,
laboratory that has a history of having
if desired, waived tests listed in
maintained a commitment to compli-
§ 493.15(c).
ance and of taking corrective action
(3) Certificate of accreditation means a
when required;
certificate issued on the basis of the
laboratory’s accreditation by an ac- (2) Is realistic in terms of its being
creditation organization approved by possible to accomplish the required
CMS (indicating that the laboratory is corrective action between the date of
deemed to meet applicable CLIA re- the exit conference and the date of the
quirements) or reissued before the ex- allegation; and
piration date, pending an appeal, in ac- (3) Indicates that the problem has
cordance with § 493.61, when a valida- been resolved.
tion or complaint survey has found the Dentist means a doctor of dental med-
laboratory to be noncompliant with icine or doctor of dental surgery li-
one or more CLIA conditions. censed by the State to practice den-
(4) Certificate of registration or registra- tistry within the State in which the
tion certificate means a certificate laboratory is located.
issued or reissued before the expiration Distributive testing means laboratory
date, pending an appeal, in accordance testing performed on the same speci-
with § 493.45, that enables the entity to men, or an aliquot of it, that requires
conduct moderate or high complexity sharing it between two or more labora-
laboratory testing or both until the en- tories to obtain all data required to
tity is determined to be in compliance complete an interpretation or calcula-
through a survey by CMS or its agent; tion necessary to provide a final re-
or in accordance with § 493.57 to an en- portable result for the originally or-
tity that is accredited by an approved dered test. When such testing occurs at
accreditation organization. multiple locations with different CLIA
(5) Certificate of waiver means a cer- certificates, it is considered distribu-
tificate issued or reissued before the tive testing.
expiration date, pending an appeal, in Equivalency means that an accredita-
accordance with § 493.37, to a labora- tion organization’s or a State labora-
tory to perform only the waived tests tory program’s requirements, taken as
listed at § 493.15(c). a whole, are equal to or more stringent
CLIA-exempt laboratory means a lab- than the CLIA requirements estab-
oratory that has been licensed or ap- lished by CMS, taken as whole. It is ac-
proved by a State where CMS has de- ceptable for an accreditation organiza-
termined that the State has enacted tion’s or State laboratory program’s
laws relating to laboratory require- requirements to be organized dif-
ments that are equal to or more strin- ferently or otherwise vary from the
gent than CLIA requirements and the CLIA requirements, as long as (1) all of
State licensure program has been ap- the requirements taken as a whole
618
would provide at least the same protec- viding information for the diagnosis,
tion as the CLIA requirements taken prevention, or treatment of any disease
as a whole; and (2) a finding of non- or impairment of, or the assessment of
compliance with respect to CLIA re- the health of, human beings. These ex-
quirements taken as a whole would be aminations also include procedures to
matched by a finding of noncompliance determine, measure, or otherwise de-
with the accreditation or State re- scribe the presence or absence of var-
quirements taken as a whole. ious substances or organisms in the
CMS agent means an entity with body. Facilities only collecting or pre-
which CMS arranges to inspect labora- paring specimens (or both) or only
tories and assess laboratory activities serving as a mailing service and not
against CLIA requirements and may be performing testing are not considered
a State survey agency, a private, non- laboratories.
profit organization other than an ap- Midlevel practitioner means a nurse
proved accreditation organization, a midwife, nurse practitioner, or physi-
component of HHS, or any other gov- cian assistant, licensed by the State
ernmental component CMS approves within which the individual practices,
for this purpose. In those instances if such licensing is required in the
where all of the laboratories in a State State in which the laboratory is lo-
are exempt from CLIA requirements, cated.
based on the approval of a State’s ex- Nonwaived test means any test sys-
emption request, the State survey tem, assay, or examination that has
agency is not the CMS agent. not been found to meet the statutory
FDA-cleared or approved test system criteria specified at section 353(d)(3) of
means a test system cleared or ap- the Public Health Service Act.
proved by the FDA through the pre- Operator means the individual or
market notification (510(k)) or pre- group of individuals who oversee all
market approval (PMA) process for in- facets of the operation of a laboratory
vitro diagnostic use. Unless otherwise and who bear primary responsibility
stated, this includes test systems ex- for the safety and reliability of the re-
empt from FDA premarket clearance sults of all specimen testing performed
or approval. in that laboratory. The term includes—
HHS means the Department of Health (1) A director of the laboratory if he
and Human Services, or its designee. or she meets the stated criteria; and
Immediate jeopardy means a situation (2) The members of the board of di-
in which immediate corrective action rectors and the officers of a laboratory
is necessary because the laboratory’s that is a small corporation under sub-
noncompliance with one or more condi- chapter S of the Internal Revenue
tion level requirements has already Code.
caused, is causing, or is likely to cause, Owner means any person who owns
at any time, serious injury or harm, or any interest in a laboratory except for
death, to individuals served by the lab- an interest in a laboratory whose stock
oratory or to the health or safety of and/or securities are publicly traded.
the general public. This term is syn- (That is e.g., the purchase of shares of
onymous with imminent and serious stock or securities on the New York
risk to human health and significant Stock Exchange in a corporation own-
hazard to the public health. ing a laboratory would not make a per-
Intentional violation means knowing son an owner for the purpose of this
and willful noncompliance with any regulation.)
CLIA condition. Party means a laboratory affected by
Kit means all components of a test any of the enforcement procedures set
that are packaged together. forth in this subpart, by CMS or the
Laboratory means a facility for the OIG, as appropriate.
biological, microbiological, serological, Performance characteristic means a
chemical, immunohematological, property of a test that is used to de-
hematological, biophysical, scribe its quality, e.g., accuracy, preci-
cytological, pathological, or other ex- sion, analytical sensitivity, analytical

amination of materials derived from specificity, reportable range, reference
the human body for the purpose of pro- range, etc.
619
§ 493.2 42 CFR Ch. IV (10–1–17 Edition)
Performance specification means a ing performance for all testing events

value or range of values for a perform- for at least one year for a specific test,
ance characteristic, established or analyte, subspecialty, or specialty and
verified by the laboratory, that is used has been designated by an HHS ap-
to describe the quality of patient test proved proficiency testing program as
results. a referee laboratory for analyzing pro-
Physician means an individual with a ficiency testing specimens for the pur-
doctor of medicine, doctor of osteop- pose of determining the correct re-
athy, or doctor of podiatric medicine sponse for the specimens in a testing
degree who is licensed by the State to event for that specific test, analyte,
practice medicine, osteopathy, or po- subspecialty, or specialty.
diatry within the State in which the Reference range means the range of
laboratory is located. test values expected for a designated
Principal sanction means the suspen- population of individuals, e.g., 95 per-
sion, limitation, or revocation of any cent of individuals that are presumed
type of CLIA certificate or the can- to be healthy (or normal).
cellation of the laboratory’s approval Reflex testing means confirmatory or
to receive Medicare payment for its additional laboratory testing that is
services. automatically requested by a labora-
Prospective laboratory means a laboratory under its standard operating pro-
tory that is operating under a registra- cedures for patient specimens when the
tion certificate or is seeking any of the laboratory’s findings indicate test re-
three other types of CLIA certificates. sults that are abnormal, are outside a
Rate of disparity means the percent- predetermined range, or meet other
age of sample validation inspections pre-established criteria for additional
for a specific accreditation organiza- testing.
tion or State where CMS, the State Repeat proficiency testing referral
survey agency or other CMS agent means a second instance in which a
finds noncompliance with one or more proficiency testing sample, or a portion
condition level requirements but no of a sample, is referred, for any reason,
comparable deficiencies were cited by to another laboratory for analysis
the accreditation organization or the prior to the laboratory’s proficiency
State, and it is reasonable to conclude testing program event cut-off date
that the deficiencies were present at within the period of time encompassing
the time of the most recent accredita- the two prior survey cycles (including
tion organization or State licensure in- initial certification, recertification, or
spection. the equivalent for laboratories sur-
veyed by an approved accreditation or-
Example: Assume the State survey agency,
CMS or other CMS agent performs 200 sam-
ganization).
ple validation inspections for laboratories Reportable range means the span of
accredited by a single accreditation organi- test result values over which the lab-
zation or licensed in an exempt State during oratory can establish or verify the ac-
a validation review period and finds that 60 curacy of the instrument or test sys-
of the 200 laboratories had one or more con- tem measurement response.
dition level requirements out of compliance. Sample in proficiency testing means
CMS reviews the validation and accredita- the material contained in a vial, on a
tion organization’s or State’s inspections of
the validated laboratories and determines
slide, or other unit that contains mate-
that the State or accreditation organization rial to be tested by proficiency testing
found comparable deficiencies in 22 of the 60 program participants. When possible,
laboratories and it is reasonable to conclude samples are of human origin.
that deficiencies were present in the remain- State includes, for purposes of this
ing 38 laboratories at the time of the accredi- part, each of the 50 States, the District
tation organization’s or State’s inspection. of Columbia, the Commonwealth of
Thirty-eight divided by 200 equals a 19 per- Puerto Rico, the Virgin Islands and a
cent rate of disparity.
political subdivision of a State where
Referee laboratory means a laboratory the State, acting pursuant to State
currently in compliance with applica- law, has expressly delegated powers to

ble CLIA requirements, that has had a the political subdivision sufficient to
record of satisfactory proficiency test- authorize the political subdivision to
620
act for the State in enforcing require- perform an assay or examination and
ments equal to or more stringent than generate test results.
CLIA requirements. Unsatisfactory proficiency testing per-
State licensure means the issuance of formance means failure to attain the
a license to, or the approval of, a lab- minimum satisfactory score for an
oratory by a State laboratory program analyte, test, subspecialty, or specialty
as meeting standards for licensing or for a testing event.
approval established under State law. Unsuccessful participation in pro-
State licensure program means a State ficiency testing means any of the fol-
laboratory licensure or approval pro- lowing:
gram. (1) Unsatisfactory performance for
State survey agency means the State the same analyte in two consecutive or
health agency or other appropriate two out of three testing events.
State or local agency that has an (2) Repeated unsatisfactory overall
agreement under section 1864 of the So- testing event scores for two consecu-
cial Security Act and is used by CMS
tive or two out of three testing events
to perform surveys and inspections.
for the same specialty or subspecialty.
Substantial allegation of noncompliance
(3) An unsatisfactory testing event
means a complaint from any of a vari-
score for those subspecialties not grad-
ety of sources (including complaints
ed by analyte (that is, bacteriology,
submitted in person, by telephone,
through written correspondence, or in mycobacteriology, virology,
newspaper or magazine articles) that, parasitology, mycology, blood compat-
if substantiated, would have an impact ibility, immunohematology, or syphilis
on the health and safety of the general serology) for the same subspecialty for
public or of individuals served by a lab- two consecutive or two out of three
oratory and raises doubts as to a lab- testing events.
oratory’s compliance with any condi- (4) Failure of a laboratory performing
tion level requirement. gynecologic cytology to meet the
Target value for quantitative tests standard at § 493.855.
means either the mean of all partici- Unsuccessful proficiency testing per-
pant responses after removal of formance means a failure to attain the
outliers (those responses greater than 3 minimum satisfactory score for an
standard deviations from the original analyte, test, subspecialty, or specialty
mean) or the mean established by de- for two consecutive or two of three
finitive or reference methods accept- consecutive testing events.
able for use in the National Reference Validation review period means the
System for the Clinical Laboratory one year time period during which CMS
(NRSCL) by the National Committee conducts validation inspections and
for the Clinical Laboratory Standards evaluates the results of the most re-
(NCCLS). In instances where definitive cent surveys performed by an accredi-
or reference methods are not available tation organization or State laboratory
or a specific method’s results dem- program.
onstrate bias that is not observed with Waived test means a test system,
actual patient specimens, as deter- assay, or examination that HHS has
mined by a defensible scientific pro-
determined meets the CLIA statutory
tocol, a comparative method or a
criteria as specified for waiver under
method group (‘‘peer’’ group) may be
section 353(d)(3) of the Public Health
used. If the method group is less than
10 participants, ‘‘target value’’ means Service Act.
the overall mean after outlier removal [57 FR 7139, Feb. 28, 1992, as amended at 57
(as defined above) unless acceptable FR 7236, Feb. 28, 1992; 57 FR 34013, July 31,
scientific reasons are available to indi- 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220,
cate that such an evaluation is not ap- Jan. 19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR
propriate. 20043, Apr. 24, 1995; 63 FR 26732, May 14, 1998;
Test system means the instructions 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22,
and all of the instrumentation, equip- 2003; 79 FR 25480, May 2, 2014; 79 FR 27157,
May 12, 2014]
ment, reagents, and supplies needed to
621
§ 493.3 42 CFR Ch. IV (10–1–17 Edition)
§ 493.3 Applicability. (c) Each laboratory must be either

CLIA-exempt or possess one of the fol-
(a) Basic rule. Except as specified in
lowing CLIA certificates, as defined in
paragraph (b) of this section, a labora-
§ 493.2:
tory will be cited as out of compliance
(1) Certificate of registration or reg-
with section 353 of the Public Health
istration certificate.
Service Act unless it—
(2) Certificate of waiver.
(1) Has a current, unrevoked or un-
(3) Certificate for PPM procedures.
suspended certificate of waiver, reg- (4) Certificate of compliance.
istration certificate, certificate of (5) Certificate of accreditation.
compliance, certificate for PPM proce-
dures, or certificate of accreditation [60 FR 20043, Apr. 24, 1995]
issued by HHS applicable to the cat-
egory of examinations or procedures § 493.15 Laboratories performing
waived tests.
performed by the laboratory; or
(2) Is CLIA-exempt. (a) Requirement. Tests for certificate
(b) Exception. These rules do not of waiver must meet the descriptive
apply to components or functions of— criteria specified in paragraph (b) of
(1) Any facility or component of a fa- this section.
cility that only performs testing for fo- (b) Criteria. Test systems are simple
rensic purposes; laboratory examinations and proce-
(2) Research laboratories that test dures which—
human specimens but do not report pa- (1) Are cleared by FDA for home use;
tient specific results for the diagnosis, (2) Employ methodologies that are so
prevention or treatment of any disease simple and accurate as to render the
or impairment of, or the assessment of likelihood of erroneous results neg-
the health of individual patients; or ligible; or
(3) Laboratories certified by the Sub- (3) Pose no reasonable risk of harm
stance Abuse and Mental Health Serv- to the patient if the test is performed
ices Administration (SAMHSA), in incorrectly.
which drug testing is performed which (c) Certificate of waiver tests. A labora-
meets SAMHSA guidelines and regulatory may qualify for a certificate of
tions. However, all other testing con- waiver under section 353 of the PHS
ducted by a SAMHSA-certified labora- Act if it restricts the tests that it per-
tory is subject to this rule. forms to one or more of the following
tests or examinations (or additional
(c) Federal laboratories. Laboratories
tests added to this list as provided
under the jurisdiction of an agency of
under paragraph (d) of this section) and
the Federal Government are subject to
no others:
the rules of this part, except that the
(1) Dipstick or Tablet Reagent Uri-
Secretary may modify the application
nalysis (non-automated) for the fol-
of such requirements as appropriate.
lowing:
[57 FR 7139, Feb. 28, 1992, as amended at 58 (i) Bilirubin;
FR 5221, Jan. 19, 1993; 60 FR 20043, Apr. 24, (ii) Glucose;
1995; 68 FR 3702, Jan. 24, 2003] (iii) Hemoglobin;
(iv) Ketone;
§ 493.5 Categories of tests by com- (v) Leukocytes;
plexity.
(vi) Nitrite;
(a) Laboratory tests are categorized (vii) pH;
as one of the following: (viii) Protein;
(1) Waived tests. (ix) Specific gravity; and
(2) Tests of moderate complexity, in- (x) Urobilinogen.
cluding the subcategory of PPM proce- (2) Fecal occult blood;
dures. (3) Ovulation tests—visual color com-
(3) Tests of high complexity. parison tests for human luteinizing
(b) A laboratory may perform only hormone;
waived tests, only tests of moderate (4) Urine pregnancy tests—visual
complexity, only PPM procedures, only color comparison tests;

tests of high complexity or any com- (5) Erythrocyte sedimentation rate—
bination of these tests. non-automated;
622
(6) Hemoglobin—copper sulfate—non- (1) Knowledge—(i) Score 1. (A) Mini-

automated; mal scientific and technical knowledge
(7) Blood glucose by glucose moni- is required to perform the test; and
toring devices cleared by the FDA spe- (B) Knowledge required to perform
cifically for home use; the test may be obtained through on-
(8) Spun microhematocrit; and the-job instruction.
(9) Hemoglobin by single analyte in- (ii) Score 3. Specialized scientific and
struments with self-contained or com- technical knowledge is essential to per-
ponent features to perform specimen/ form preanalytic, analytic or
reagent interaction, providing direct postanalytic phases of the testing.
measurement and readout. (2) Training and experience—(i) Score 1.
(d) Revisions to criteria for test cat- (A) Minimal training is required for
egorization and the list of waived tests. preanalytic, analytic and postanalytic
HHS will determine whether a labora- phases of the testing process; and
tory test meets the criteria listed (B) Limited experience is required to
under paragraph (b) of this section for perform the test.
a waived test. Revisions to the list of (ii) Score 3. (A) Specialized training is
waived tests approved by HHS will be essential to perform the preanalytic,
published in the FEDERAL REGISTER in analytic or postanalytic testing proc-
a notice with opportunity for com- ess; or
ment. (B) Substantial experience may be
(e) Laboratories eligible for a certifi- necessary for analytic test perform-
cate of waiver must— ance.
(1) Follow manufacturers’ instruc- (3) Reagents and materials prepara-
tions for performing the test; and tion—(i) Score 1. (A) Reagents and ma-
(2) Meet the requirements in subpart terials are generally stable and reli-
B, Certificate of Waiver, of this part. able; and
(B) Reagents and materials are pre-
[57 FR 7139, Feb. 28, 1992, as amended at 58 packaged, or premeasured, or require
FR 5221, Jan. 19, 1993] no special handling, precautions or
storage conditions.
§ 493.17 Test categorization.
(ii) Score 3. (A) Reagents and mate-
(a) Categorization by criteria. Notices rials may be labile and may require
will be published in the FEDERAL REG- special handling to assure reliability;
ISTER which list each specific test sys- or
tem, assay, and examination cat- (B) Reagents and materials prepara-
egorized by complexity. Using the tion may include manual steps such as
seven criteria specified in this para- gravimetric or volumetric measure-
graph for categorizing tests of mod- ments.
erate or high complexity, each specific (4) Characteristics of operational steps—
laboratory test system, assay, and ex- (i) Score 1. Operational steps are either
amination will be graded for level of automatically executed (such as
complexity by assigning scores of 1, 2, pipetting, temperature monitoring, or
or 3 within each criteria. The score of timing of steps), or are easily con-
‘‘1’’ indicates the lowest level of com- trolled.
plexity, and the score of ‘‘3’’ indicates (ii) Score 3. Operational steps in the
the highest level. These scores will be testing process require close moni-
totaled. Test systems, assays or exami- toring or control, and may require spe-
nations receiving scores of 12 or less cial specimen preparation, precise tem-
will be categorized as moderate com- perature control or timing of proce-
plexity, while those receiving scores dural steps, accurate pipetting, or ex-
above 12 will be categorized as high tensive calculations.
complexity. (5) Calibration, quality control, and
proficiency testing materials—(i) Score 1.
NOTE: A score of ‘‘2’’ will be assigned to a
criteria heading when the characteristics for (A) Calibration materials are stable
a particular test are intermediate between and readily available;

the descriptions listed for scores of ‘‘1’’ and (B) Quality control materials are sta-
‘‘3.’’ ble and readily available; and
623
§ 493.19 42 CFR Ch. IV (10–1–17 Edition)
(C) External proficiency testing ma- (A) When categorizing previously

terials, when available, are stable. uncategorized new technology;
(ii) Score 3. (A) Calibration materials, (B) When FDA determines it to be
if available, may be labile; necessary in cases involving a request
(B) Quality control materials may be for a change in categorization; and
labile, or not available; or (C) If a manufacturer requests review
(C) External proficiency testing ma- of a categorization decision by FDA in
terials, if available, may be labile. accordance with 21 CFR 10.75.
(6) Test system troubleshooting and (ii) Test categorization will be effec-
equipment maintenance—(i) Score 1. (A) tive as of the notification to the appli-
Test system troubleshooting is auto- cant.
matic or self-correcting, or clearly de-
(2) For test systems, assays, or ex-
scribed or requires minimal judgment;
aminations not commercially avail-
and
able, a laboratory or professional group
(B) Equipment maintenance is pro-
vided by the manufacturer, is seldom may submit a written request for cat-
needed, or can easily be performed. egorization to PHS. These requests will
(ii) Score 3. (A) Troubleshooting is be forwarded to CDC for evaluation;
not automatic and requires decision- CDC will determine complexity cat-
making and direct intervention to re- egory and notify the applicant, CMS,
solve most problems; or and FDA of the categorization deci-
(B) Maintenance requires special sion. In the case of request for a change
knowledge, skills, and abilities. of category or for previously
(7) Interpretation and judgment—(i) uncategorized new technology, PHS
Score 1. (A) Minimal interpretation and will receive the request application and
judgment are required to perform forward it to CDC for categorization.
preanalytic, analytic and postanalytic (3) A request for recategorization will
processes; and be accepted for review if it is based on
(B) Resolution of problems requires new information not previously sub-
limited independent interpretation and mitted in a request for categorization
judgment; and or recategorization by the same appli-
(ii) Score 3. (A) Extensive independent cant and will not be considered more
interpretation and judgment are re- frequently than once per year.
quired to perform the preanalytic, ana- (4) If a laboratory test system, assay
lytic or postanalytic processes; and or examination does not appear on the
(B) Resolution of problems requires lists of tests in the FEDERAL REGISTER
extensive interpretation and judgment. notices, it is considered to be a test of
(b) Revisions to the criteria for cat- high complexity until PHS, upon re-
egorization. The Clinical Laboratory quest, reviews the matter and notifies
Improvement Advisory Committee, as the applicant of its decision. Test cat-
defined in subpart T of this part, will egorization is effective as of the notifi-
conduct reviews upon request of HHS cation to the applicant.
and recommend to HHS revisions to (5) PHS will publish revisions peri-
the criteria for categorization of tests. odically to the list of moderate and
(c) Process for device/test categorization high complexity tests in the FEDERAL
utilizing the scoring system under REGISTER in a notice with opportunity
§ 493.17(a). (1)(i) For new commercial for comment.
test systems, assays, or examinations,
the manufacturer, as part of its 510(k) [57 FR 7139, Feb. 28, 1992, as amended at 58
and PMA application to FDA, will sub- FR 5222, Jan. 19, 1993]
mit supporting data for device/test cat-
§ 493.19 Provider-performed micros-
egorization. FDA will determine the copy (PPM) procedures.
complexity category, notify the manu-
facturers directly, and will simulta- (a) Requirement. To be categorized as
neously inform both CMS and CDC of a PPM procedure, the procedure must
the device/test category. FDA will con- meet the criteria specified in para-
sult with CDC concerning test cat- graph (b) of this section.
egorization in the following three situ- (b) Criteria. Procedures must meet
ations: the following specifications:
624
(1) The examination must be person- (8) Fecal leukocyte examinations.

ally performed by one of the following (9) Qualitative semen analysis (lim-
practitioners: ited to the presence or absence of
(i) A physician during the patient’s sperm and detection of motility).
visit on a specimen obtained from his (d) Revisions to criteria and the list of
or her own patient or from a patient of PPM procedures. (1) The CLIAC con-
a group medical practice of which the ducts reviews upon HHS’ request and
physician is a member or an employee. recommends to HHS revisions to the
(ii) A midlevel practitioner, under criteria for categorization of proce-
the supervision of a physician or in
dures.
independent practice only if authorized
by the State, during the patient’s visit (2) HHS determines whether a labora-
on a specimen obtained from his or her tory procedure meets the criteria listed
own patient or from a patient of a clin- under paragraph (b) of this section for
ic, group medical practice, or other a PPM procedure. Revisions to the list
health care provider of which the mid- of PPM procedures proposed by HHS
level practitioner is a member or an are published in the FEDERAL REGISTER
employee. as a notice with an opportunity for
(iii) A dentist during the patient’s public comment.
visit on a specimen obtained from his (e) Laboratory requirements. Labora-
or her own patient or from a patient of tories eligible to perform PPM exami-
a group dental practice of which the nations must—
dentist is a member or an employee. (1) Meet the applicable requirements
(2) The procedure must be cat- in subpart C or subpart D, and subparts
egorized as moderately complex. F, H, J, K, and M of this part.
(3) The primary instrument for per- (2) Be subject to inspection as speci-
forming the test is the microscope, fied under subpart Q of this part.
limited to bright-field or phase-con-
trast microscopy. [60 FR 20044, Apr. 24, 1995; 68 FR 50723, Aug.
(4) The specimen is labile or delay in 22, 2003]
performing the test could compromise
the accuracy of the test result. § 493.20 Laboratories performing tests
(5) Control materials are not avail- of moderate complexity.
able to monitor the entire testing proc- (a) A laboratory may qualify for a
ess. certificate to perform tests of mod-
(6) Limited specimen handling or erate complexity provided that it re-
processing is required. stricts its test performance to waived
(c) Provider-performed microscopy tests or examinations and one or more
(PPM) examinations. A laboratory may tests or examinations meeting criteria
qualify to perform tests under this sec- for tests of moderate complexity in-
tion if it restricts PPM examinations cluding the subcategory of PPM proce-
to one or more of the following procedures.
dures (or additional procedures added
(b) A laboratory that performs tests
to this list as provided under paragraph
or examinations of moderate com-
(d) of this section), waived tests and no
others: plexity must meet the applicable re-
(1) All direct wet mount preparations quirements in subpart C or subpart D,
for the presence or absence of bacteria, and subparts F, H, J, K, M, and Q of
fungi, parasites, and human cellular this part. Under a registration certifi-
elements. cate or certificate of compliance, lab-
(2) All potassium hydroxide (KOH) oratories also performing PPM proce-
preparations. dures must meet the inspection re-
(3) Pinworm examinations. quirements at §§ 493.1773 and 493.1777.
(4) Fern tests. (c) If the laboratory also performs
(5) Post-coital direct, qualitative ex- waived tests, compliance with subparts
aminations of vaginal or cervical mu- H, J, K, and M of this part is not appli-
cous. cable to the waived tests. However, the

(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
625
§ 493.25 42 CFR Ch. IV (10–1–17 Edition)
laboratory must comply with the re- the certificate of the designated pri-
quirements in §§ 493.15(e), 493.1773, and mary site or home base, using its ad-
493.1775. dress.
(2) Not-for-profit or Federal, State,
FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, or local government laboratories that
2003] engage in limited (not more than a
combination of 15 moderately complex
§ 493.25 Laboratories performing tests or waived tests per certificate) public
of high complexity. health testing may file a single appli-
(a) A laboratory must obtain a cer- cation.
tificate for tests of high complexity if (3) Laboratories within a hospital
it performs one or more tests that that are located at contiguous build-
meet the criteria for tests of high com- ings on the same campus and under
plexity as specified in § 493.17(a). common direction may file a single ap-
(b) A laboratory performing one or plication or multiple applications for
more tests of high complexity must the laboratory sites within the same
meet the applicable requirements of physical location or street address.
subpart C or subpart D, and subparts F, (c) Application format and contents.
H, J, K, M, and Q of this part. The application must—
(c) If the laboratory also performs (1) Be made to HHS or its designee on
tests of moderate complexity, the ap- a form or forms prescribed by HHS;
plicable requirements of subparts H, J, (2) Be signed by an owner, or by an
K, M, and Q of this part must be met. authorized representative of the lab-
Under a registration certificate or cer- oratory who attests that the labora-
tificate of compliance, PPM procedures tory will be operated in accordance
must meet the inspection requirements with requirements established by the
at §§ 493.1773 and 493.1777. Secretary under section 353 of the PHS
(d) If the laboratory also performs Act; and
waived tests, the requirements of sub- (3) Describe the characteristics of the
parts H, J, K, and M are not applicable laboratory operation and the examina-
to the waived tests. However, the lab- tions and other test procedures per-
oratory must comply with the require- formed by the laboratory including—
ments in §§ 493.15(e), 493.1773, and (i) The name and the total number of
493.1775. test procedures and examinations per-
formed annually (excluding tests the
[57 FR 7139, Feb. 28, 1992, as amended at 60 laboratory may run for quality control,
FR 20044, Apr. 24, 1995; 68 FR 3702, Jan. 24, quality assurance or proficiency test-
2003; 68 FR 50723, Aug. 22, 2003]
ing purposes;
(ii) The methodologies for each lab-
Subpart B—Certificate of Waiver oratory test procedure or examination
performed, or both; and
SOURCE: 57 FR 7142, Feb. 28, 1992, unless (iii) The qualifications (educational
otherwise noted. background, training, and experience)
of the personnel directing and super-
§ 493.35 Application for a certificate of vising the laboratory and performing
waiver. the laboratory examinations and test
(a) Filing of application. Except as procedures.
specified in paragraph (b) of this sec- (d) Access requirements. Laboratories
tion, a laboratory performing only one that perform one or more waived tests
or more waived tests listed in § 493.15 listed in § 493.15(c) and no other tests
must file a separate application for must meet the following conditions:
each laboratory location. (1) Make records available and sub-
(b) Exceptions. (1) Laboratories that mit reports to HHS as HHS may rea-
are not at a fixed location, that is, lab- sonably require to determine compli-
oratories that move from testing site ance with this section and § 493.15(e);
to testing site, such as mobile units (2) Agree to permit announced and
providing laboratory testing, health unannounced inspections by HHS in ac-

screening fairs, or other temporary cordance with subpart Q of this part
testing locations may be covered under under the following circumstances:
626
(i) When HHS has substantive reason requirements of this subpart. In addi-
to believe that the laboratory is being tion, failure to meet the requirements
operated in a manner that constitutes of this subpart will result in suspension
an imminent and serious risk to human or denial of payments under Medicare
health. and Medicaid in accordance with sub-
(ii) To evaluate complaints from the part R of this part.
public. (e)(1) A certificate of waiver issued
(iii) On a random basis to determine under this subpart is valid for no more
whether the laboratory is performing than 2 years. In the event of a non-
tests not listed in § 493.15. compliance determination resulting in
(iv) To collect information regarding
HHS action to revoke, suspend, or
the appropriateness of waiver of tests
limit the laboratory’s certificate of
listed in § 493.15.
waiver, HHS will provide the labora-
(e) Denial of application. If HHS deter-
mines that the application for a certifi- tory with a statement of grounds on
cate of waiver is to be denied, HHS which the determination of non-com-
will— pliance is based and offer an oppor-
(1) Provide the laboratory with a tunity for appeal as provided in sub-
written statement of the grounds on part R of this part.
which the denial is based and an oppor- (2) If the laboratory requests a hear-
tunity for appeal, in accordance with ing within the time specified by HHS,
the procedures set forth in subpart R of it retains its certificate of waiver or re-
this part; issued certificate of waiver until a de-
(2) Notify a laboratory that has its cision is made by an administrative
application for a certificate of waiver law judge, as specified in subpart R of
denied that it cannot operate as a lab- this part, except when HHS finds that
oratory under the PHS Act unless the conditions at the laboratory pose an
denial is overturned at the conclusion imminent and serious risk to human
of the administrative appeals process health.
provided by subpart R; and (3) For laboratories receiving pay-
(3) Notify the laboratory that it is ment from the Medicare or Medicaid
not eligible for payment under the program, such payments will be sus-
Medicare and Medicaid programs.
pended on the effective date specified
[57 FR 7142, Feb. 28, 1992, as amended at 58 in the notice to the laboratory of a
FR 5222, Jan. 19, 1993; 60 FR 20044, Apr. 24, non-compliance determination even if
1995] there has been no appeals decision
§ 493.37 Requirements for a certificate issued.
of waiver. (f) A laboratory seeking to renew its
certificate of waiver must—
(a) HHS will issue a certificate of
waiver to a laboratory only if the lab- (1) Complete the renewal application
oratory meets the requirements of prescribed by HHS and return it to
§ 493.35. HHS not less than 9 months nor more
(b) Laboratories issued a certificate than 1 year before the expiration of the
of waiver— certificate; and
(1) Are subject to the requirements of (2) Meet the requirements of §§ 493.35
this subpart and § 493.15(e) of subpart A and 493.37.
of this part; and (g) A laboratory with a certificate of
(2) Must permit announced or unan- waiver that wishes to perform exami-
nounced inspections by HHS in accord- nations or tests not listed in the waiv-
ance with subpart Q of this part. er test category must meet the require-
(c) Laboratories must remit the cer- ments set forth in subpart C or subpart
tificate of waiver fee specified in sub- D of this part, as applicable.
part F of this part.
(d) In accordance with subpart R of [57 FR 7142, Feb. 28, 1992, as amended at 58
this part, HHS will suspend or revoke FR 5222, Jan. 19, 1993; 60 FR 20045, Apr. 24,
or limit a laboratory’s certificate of 1995]
waiver for failure to comply with the
627
§ 493.39 42 CFR Ch. IV (10–1–17 Edition)
§ 493.39 Notification requirements for (3) Laboratories within a hospital

laboratories issued a certificate of that are located at contiguous build-
waiver. ings on the same campus and under
Laboratories performing one or more common direction may file a single ap-
tests listed in § 493.15 and no others plication or multiple applications for
must notify HHS or its designee— the laboratory sites within the same
(a) Before performing and reporting physical location or street address.
results for any test or examination (c) Application format and contents.
that is not specified under § 493.15 for The application must—(1) Be made to
which the laboratory does not have the HHS or its designee on a form or forms
appropriate certificate as required in prescribed by HHS;
subpart C or subpart D of this part, as (2) Be signed by an owner, or by an
applicable; and authorized representative of the lab-
(b) Within 30 days of any change(s) oratory who attests that the labora-
in— tory will be operated in accordance
(1) Ownership; with the requirements established by
(2) Name; the Secretary under section 353 of the
(3) Location; or Public Health Service Act; and
(4) Director. (3) Describe the characteristics of the
laboratory operation and the examina-
[57 FR 7142, Feb. 28, 1992, as amended at 60 tions and other test procedures per-
FR 20045, Apr. 24, 1995]
formed by the laboratory including—
(i) The name and total number of test
Subpart C—Registration Certifi- procedures and examinations per-
cate, Certificate for Provider- formed annually (excluding waived
performed Microscopy Proce- tests or tests for quality control, qual-
dures, and Certificate of ity assurance or proficiency testing
Compliance purposes);
(ii) The methodologies for each lab-
oratory test procedure or examination
SOURCE: 57 FR 7143, Feb. 28, 1992, unless
otherwise noted.
performed, or both;
(iii) The qualifications (educational
§ 493.43 Application for registration background, training, and experience)
certificate, certificate for provider- of the personnel directing and super-
performed microscopy (PPM) proce- vising the laboratory and performing
dures, and certificate of compli- the examinations and test procedures.
ance. (d) Access and reporting requirements.
(a) Filing of application. Except as All laboratories must make records
specified in paragraph (b) of this sec- available and submit reports to HHS as
tion, all laboratories performing non- HHS may reasonably require to deter-
waived testing must file a separate ap- mine compliance with this section.
plication for each laboratory location. [57 FR 7143, Feb. 28, 1992, as amended at 58
(b) Exceptions. (1) Laboratories that FR 5222, Jan. 19, 1993; 58 FR 39155, July 22,
are not at a fixed location, that is, lab- 1993; 60 FR 20045, Apr. 24, 1995; 68 FR 3702,
oratories that move from testing site Jan. 24, 2003]
to testing site, such as mobile units
providing laboratory testing, health § 493.45 Requirements for a registra-
screening fairs, or other temporary tion certificate.
testing locations may be covered under Laboratories performing only waived
the certificate of the designated pri- tests, PPM procedures, or any com-
mary site or home base, using its ad- bination of these tests, are not re-
dress. quired to obtain a registration certifi-
(2) Not-for-profit or Federal, State, cate.
or local government laboratories that (a) A registration certificate is re-
engage in limited (not more than a quired—(1) Initially for all laboratories
combination of 15 moderately complex performing test procedures of moderate
or waived tests per certificate) public complexity (other than the sub-
health testing may file a single appli- category of PPM procedures) or high
cation. complexity, or both; and
628
(2) For all laboratories that have nial of a laboratory’s certificate of

been issued a certificate of waiver or compliance application, HHS will pro-
certificate for PPM procedures that in- vide the laboratory with a statement of
tend to perform tests of moderate or grounds on which the noncompliance
high complexity, or both, in addition determination is based and offer an op-
to those tests listed in § 493.15(c) or portunity for appeal as provided in sub-
specified as PPM procedures. part R.
(b) HHS will issue a registration cer- (g) If the laboratory requests a hear-
tificate if the laboratory— ing within the time specified by HHS,
(1) Complies with the requirements of it retains its registration certificate or
§ 493.43; reissued registration certificate until a
(2) Agrees to notify HHS or its des- decision is made by an administrative
ignee within 30 days of any changes in law judge as provided in subpart R of
ownership, name, location, director or this part, except when HHS finds that
technical supervisor (laboratories per- conditions at the laboratory pose an
forming high complexity testing only); imminent and serious risk to human
(3) Agrees to treat proficiency testing health.
samples in the same manner as it (h) For laboratories receiving pay-
treats patient specimens; and ment from the Medicare or Medicaid
(4) Remits the fee for the registration program, such payments will be sus-
certificate, as specified in subpart F of pended on the effective date specified
this part. in the notice to the laboratory of de-
(c) Prior to the expiration of the reg- nial of the certificate application even
istration certificate, a laboratory if there has been no appeals decision
must— issued.
(1) Remit the certificate fee specified [57 FR 7143, Feb. 28, 1992, as amended at 58
in subpart F of this part; FR 5223, Jan. 19, 1993; 60 FR 20045, Apr. 24,
(2) Be inspected by HHS as specified 1995; 68 FR 3702, Jan. 24, 2003]
in subpart Q of this part; and
(3) Demonstrate compliance with the § 493.47 Requirements for a certificate
applicable requirements of this subpart for provider-performed microscopy
and subparts H, J, K, M, and Q of this (PPM) procedures.
part. (a) A certificate for PPM procedures
(d) In accordance with subpart R of is required—
this part, HHS will initiate suspension (1) Initially for all laboratories per-
or revocation of a laboratory’s reg- forming test procedures specified as
istration certificate and will deny the PPM procedures; and
laboratory’s application for a certifi- (2) For all certificate of waiver lab-
cate of compliance for failure to com- oratories that intend to perform only
ply with the requirements set forth in test procedures specified as PPM proce-
this subpart. HHS may also impose cer- dures in addition to those tests listed
tain alternative sanctions. In addition, in § 493.15(c).
failure to meet the requirements of (b) HHS will issue a certificate for
this subpart will result in suspension of PPM procedures if the laboratory—
payments under Medicare and Medicaid (1) Complies with the requirements of
as specified in subpart R of this part. § 493.43; and
(e) A registration certificate is— (2) Remits the fee for the certificate,
(1) Valid for a period of no more than as specified in subpart F of this part.
two years or until such time as an in- (c) Laboratories issued a certificate
spection to determine program compli- for PPM procedures are subject to—
ance can be conducted, whichever is (1) The notification requirements of
shorter; and § 493.53;
(2) Not renewable; however, the reg- (2) The applicable requirements of
istration certificate may be reissued if this subpart and subparts H, J, K, and
compliance has not been determined by M of this part; and
HHS prior to the expiration date of the (3) Inspection only under the cir-
registration certificate. cumstances specified under §§ 493.1773

(f) In the event of a noncompliance and 493.1775, but are not routinely in-
determination resulting in an HHS de- spected to determine compliance with
629
§ 493.49 42 CFR Ch. IV (10–1–17 Edition)
the requirements specified in para- § 493.15 or tests categorized as moderate

graphs (c) (1) and (2) of this section. complexity (including the subcategory)
(d) In accordance with subpart R of or high complexity.
this part, HHS will initiate suspension, (c) Failure to comply with the re-
limitation, or revocation of a labora- quirements of this subpart will result
tory’s certificate for PPM procedures in—
for failure to comply with the applica- (1) Suspension, revocation or limita-
ble requirements set forth in this sub- tion of a laboratory’s certificate of
part. HHS may also impose certain al- compliance in accordance with subpart
ternative sanctions. In addition, failure R of this part; and
to meet the requirements of this sub- (2) Suspension or denial of payments
part may result in suspension of all or
under Medicare and Medicaid in ac-
part of payments under Medicare and
cordance with subpart R of this part.
Medicaid, as specified in subpart R of
this part. (d) A certificate of compliance issued
(e) A certificate for PPM procedures under this subpart is valid for no more
is valid for a period of no more than 2 than 2 years.
years. (e) In the event of a noncompliance
determination resulting in an HHS ac-
[58 FR 5223, Jan. 19, 1993, as amended at 60 tion to revoke, suspend or limit the
FR 20045, Apr. 24, 1995; 68 FR 3702, Jan. 24,
2003; 68 FR 50723, Aug. 22, 2003]
laboratory’s certificate of compliance,
HHS will—
§ 493.49 Requirements for a certificate (1) Provide the laboratory with a
of compliance. statement of grounds on which the de-
A certificate of compliance may in- termination of noncompliance is based;
clude any combination of tests cat- and
egorized as high complexity or mod- (2) Offer an opportunity for appeal as
erate complexity or listed in § 493.15(c) provided in subpart R of this part. If
as waived tests. Moderate complexity the laboratory requests a hearing with-
tests may include those specified as in 60 days of the notice of sanction, it
PPM procedures. retains its certificate of compliance or
(a) HHS will issue a certificate of reissued certificate of compliance until
compliance to a laboratory only if the a decision is made by an administra-
laboratory— tive law judge (ALJ) as provided in
(1) Meets the requirements of §§ 493.43 subpart R of this part, except when
and 493.45; HHS finds that conditions at the lab-
(2) Remits the certificate fee speci- oratory pose an imminent and serious
fied in subpart F of this part; and risk to human health or when the cri-
(3) Meets the applicable requirements teria at § 493.1840(a) (4) and (5) are met.
of this subpart and subparts H, J, K, M, (f) For laboratories receiving pay-
and Q of this part. ment from the Medicare or Medicaid
(b) Laboratories issued a certificate program, such payments will be sus-
of compliance— pended on the effective date specified
(1) Are subject to the notification rein the notice to the laboratory of a
quirements of § 493.51; and noncompliance determination even if
(2) Must permit announced or unan-
there has been no appeals decision
nounced inspections by HHS in accord-
issued.
ance with subpart Q of this part—
(i) To determine compliance with the (g) A laboratory seeking to renew its
applicable requirements of this part; certificate of compliance must—
(ii) To evaluate complaints; (1) Complete and return the renewal
(iii) When HHS has substantive rea- application to HHS 9 to 12 months
son to believe that tests are being per- prior to the expiration of the certifi-
formed, or the laboratory is being oper- cate of compliance; and
ated in a manner that constitutes an (2) Meet the requirements of § 493.43
imminent and serious risk to human and paragraphs (a)(2) and (b)(2) of this
health; and section.

(iv) To collect information regarding (h) If HHS determines that the appli-
the appropriateness of tests listed in cation for the renewal of a certificate
630
of compliance must be denied or lim- § 493.53 Notification requirements for

ited, HHS will notify the laboratory in laboratories issued a certificate for
writing of the— provider-performed microscopy
(1) Basis for denial of the application; (PPM) procedures.
and Laboratories issued a certificate for
(2) Opportunity for appeal as pro- PPM procedures must notify HHS or
vided in subpart R of this part. its designee—
(i) If the laboratory requests a hear- (a) Before performing and reporting
ing within the time period specified by results for any test of moderate or high
HHS, the laboratory retains its certifi- complexity, or both, in addition to
cate of compliance or reissued certifi- tests specified as PPM procedures or
cate of compliance until a decision is any test or examination that is not
made by an ALJ as provided in subpart specified under § 493.15(c), for which it
R, except when HHS finds that condi- does not have a registration certificate
tions at the laboratory pose an immi- as required in subpart C or subpart D,
nent and serious risk to human health. as applicable, of this part; and
(b) Within 30 days of any change in—
(j) For laboratories receiving pay-
(1) Ownership;
ment from the Medicare or Medicaid
(2) Name;
program, such payments will be sus-
(3) Location; or
pended on the effective date specified (4) Director.
in the notice to the laboratory of non-
renewal of the certificate of compli- [58 FR 5224, Jan. 19, 1993, as amended at 60
ance even if there has been no appeals FR 20046, Apr. 24, 1995]
decision issued.
Subpart D—Certificate of
FR 3702, Jan. 24, 2003]
Accreditation
§ 493.51 Notification requirements for SOURCE: 57 FR 7144, Feb. 28, 1992, unless
laboratories issued a certificate of otherwise noted.
compliance.
§ 493.55 Application for registration
Laboratories issued a certificate of certificate and certificate of accred-
compliance must meet the following itation.
conditions: (a) Filing of application. A laboratory
(a) Notify HHS or its designee within may be issued a certificate of accredi-
30 days of any change in— tation in lieu of the applicable certifi-
(1) Ownership; cate specified in subpart B or subpart C
(2) Name; of this part provided the laboratory—
(3) Location; (1) Meets the standards of a private
(4) Director; or non-profit accreditation program ap-
(5) Technical supervisor (laboratories proved by HHS in accordance with sub-
performing high complexity only). part E; and
(b) Notify HHS no later than 6 (2) Files a separate application for
months after performing any test or each location, except as specified in
examination within a specialty or sub- paragraph (b) of this section.
specialty area that is not included on (b) Exceptions. (1) Laboratories that
the laboratory’s certificate of compli- are not at fixed locations, that is, lab-
ance, so that compliance with require- oratories that move from testing site
ments can be determined. to testing site, such as mobile units
providing laboratory testing, health
(c) Notify HHS no later than 6
screening fairs, or other temporary
months after any deletions or changes
testing locations may be covered under
in test methodologies for any test or
the certificate of the designated pri-
examination included in a specialty or
mary site or home base, using its ad-
subspecialty, or both, for which the
dress.
laboratory has been issued a certificate (2) Not-for-profit or Federal, State,
of compliance. or local government laboratories that

[57 FR 7143, Feb. 28, 1992, as amended at 60 engage in limited (not more than a
FR 20046, Apr. 24, 1995] combination of 15 moderately complex
631
§ 493.57 42 CFR Ch. IV (10–1–17 Edition)
or waived tests per certificate) public (2) Agrees to notify HHS within 30
health testing may file a single appli- days of any changes in ownership,
cation. name, location, director, or supervisor
(3) Laboratories within a hospital (laboratories performing high com-
that are located at contiguous build- plexity testing only);
ings on the same campus and under (3) Agrees to treat proficiency testing
common direction may file a single ap- samples in the same manner as it
plication or multiple applications for treats patient specimens; and
the laboratory sites within the same (4) Remits the fee for the registration
physical location or street address. certificate specified in subpart F of
(c) Application format and contents. this part.
The application must—(1) Be made to (b)(1) The laboratory must provide
HHS on a form or forms prescribed by HHS with proof of accreditation by an
HHS; approved accreditation program—
(2) Be signed by an owner or author- (i) Within 11 months of issuance of
ized representative of the laboratory the registration certificate; or
who attests that the laboratory will be (ii) Prior to the expiration of the cer-
operated in accordance with the re- tificate of compliance.
quirements established by the Sec- (2) If such proof of accreditation is
retary under section 353 of the Public not supplied within this timeframe, the
Health Service Act; and laboratory must meet, or continue to
(3) Describe the characteristics of the meet, the requirements of § 493.49.
laboratory operation and the examina- (c) In accordance with subpart R of
tions and other test procedures per- this part, HHS will initiate suspension,
formed by the laboratory including— revocation, or limitation of a labora-
(i) The name and total number of tory’s registration certificate and will
tests and examinations performed an- deny the laboratory’s application for a
nually (excluding waived tests and certificate of accreditation for failure
tests for quality control, quality assur- to comply with the requirements set
ance or proficiency testing purposes); forth in this subpart. In addition, fail-
(ii) The methodologies for each lab- ure to meet the requirements of this
oratory test procedure or examination subpart will result in suspension or de-
performed, or both; and nial of payments under Medicare and
(iii) The qualifications (educational Medicaid as specified in subpart R of
background, training, and experience) this part.
of the personnel directing and super- (d) A registration certificate is valid
vising the laboratory and performing for a period of no more than 2 years.
the laboratory examinations and test However, it may be reissued if the lab-
procedures. oratory is subject to subpart C of this
(d) Access and reporting requirements. part, as specified in § 493.57(b)(2) and
All laboratories must make records compliance has not been determined by
available and submit reports to HHS as HHS before the expiration date of the
HHS may reasonably require to deter- registration certificate.
mine compliance with this section. (e) In the event that the laboratory
[57 FR 7144, Feb. 28, 1992, as amended at 58 does not meet the requirements of this
FR 5224, Jan. 19, 1993; 58 FR 39155, July 22, subpart, HHS will—
1993; 60 FR 20046, Apr. 24, 1995] (1) Deny a laboratory’s request for
certificate of accreditation;
§ 493.57 Requirements for a registra- (2) Notify the laboratory if it must
tion certificate. meet the requirements for a certificate
A registration certificate is required as defined in subpart C of this part;
for all laboratories seeking a certifi- (3) Provide the laboratory with a
cate of accreditation, unless the lab- statement of grounds on which the ap-
oratory holds a valid certificate of plication denial is based;
compliance issued by HHS. (4) Offer an opportunity for appeal on
(a) HHS will issue a registration cer- the application denial as provided in
tificate if the laboratory— subpart R of this part. If the laboratory

(1) Complies with the requirements of requests a hearing within the time
§ 493.55; specified by HHS, the laboratory will
632
retain its registration certificate or re- (3) May be subject to suspension, rev-
issued registration certificate until a ocation or limitation of the labora-
decision is made by an administrative tory’s certificate of accreditation or
law judge as provided in subpart R, un- certain alternative sanctions; and
less HHS finds that conditions at the (4) May be subject to suspension of
laboratory pose an imminent and seri- payments under Medicare and Medicaid
ous risk to human health; and as specified in subpart R.
(5) For those laboratories receiving (d) A certificate of accreditation
payment from the Medicare or Med- issued under this subpart is valid for no
icaid program, such payments will be more than 2 years. In the event of a
suspended on the effective date speci- non-compliance determination as a re-
fied in the notice to the laboratory of sult of a random sample validation or
denial of the request even if there has complaint inspection, a laboratory will
been no appeals decision issued. be subject to a full review by HHS in
accordance with § 488.11 of this chapter.
[57 FR 7144, Feb. 28, 1992, as amended at 60
FR 20046, Apr. 24, 1995]
(e) Failure to meet the applicable re-
quirements of part 493, will result in an
§ 493.61 Requirements for a certificate action by HHS to suspend, revoke or
of accreditation. limit the certificate of accreditation.
HHS will—
(a) HHS will issue a certificate of ac-
(1) Provide the laboratory with a
creditation to a laboratory if the lab-
statement of grounds on which the de-
oratory—
termination of noncompliance is based;
(1) Meets the requirements of § 493.57
(2) Notify the laboratory if it is eligi-
or, if applicable, § 493.49 of subpart C of
ble to apply for a certificate as defined
this part; and
in subpart C of this part; and
(2) Remits the certificate of accredi- (3) Offer an opportunity for appeal as
tation fee specified in subpart F of this provided in subpart R of this part.
part. (f) If the laboratory requests a hear-
(b) Laboratories issued a certificate ing within the time frame specified by
of accreditation must— HHS—
(1) Treat proficiency testing samples (1) It retains its certificate of accred-
in the same manner as patient samples; itation or reissued certificate of ac-
(2) Meet the requirements of § 493.63; creditation until a decision is made by
(3) Comply with the requirements of an administrative law judge as pro-
the approved accreditation program; vided in subpart R of this part, unless
(4) Permit random sample validation HHS finds that conditions at the lab-
and complaint inspections as required oratory pose an imminent and serious
in subpart Q of this part; risk to human health; and
(5) Permit HHS to monitor the cor- (2) For those laboratories receiving
rection of any deficiencies found payments from the Medicare or Med-
through the inspections specified in icaid program, such payments will be
paragraph (b)(4) of this section; suspended on the effective date speci-
(6) Authorize the accreditation pro- fied in the notice to the laboratory
gram to release to HHS the labora- even if there has been no appeals deci-
tory’s inspection findings whenever sion issued.
HHS conducts random sample or com- (g) In the event the accreditation or-
plaint inspections; and ganization’s approval is removed by
(7) Authorize its accreditation pro- HHS, the laboratory will be subject to
gram to submit to HHS the results of the applicable requirements of subpart
the laboratory’s proficiency testing. C of this part or § 493.57.
(c) A laboratory failing to meet the (h) A laboratory seeking to renew its
requirements of this section— certificate of accreditation must—
(1) Will no longer meet the require- (1) Complete and return the renewal
ments of this part by virtue of its ac- application to HHS 9 to 12 months
creditation in an approved accredita- prior to the expiration of the certifi-
tion program; cate of accreditation;

(2) Will be subject to full determina- (2) Meet the requirements of this sub-
tion of compliance by HHS; part; and
633
§ 493.63 42 CFR Ch. IV (10–1–17 Edition)
(3) Submit the certificate of accredi- cluded in a specialty or subspecialty,

tation fee specified in subpart F of this or both, for which the laboratory has
part. been issued a certificate of accredita-
(i) If HHS determines that the re- tion.
newal application for a certificate of
accreditation is to be denied or lim- Subpart E—Accreditation by a Pri-
ited, HHS will notify the laboratory in vate, Nonprofit Accreditation
writing of—
(1) The basis for denial of the applica-
Organization or Exemption
tion; Under an Approved State
(2) Whether the laboratory is eligible Laboratory Program
for a certificate as defined in subpart C
of this part; SOURCE: 63 FR 26732, May 14, 1998, unless
(3) The opportunity for appeal on otherwise noted.
HHS’s action to deny the renewal ap-
plication for certificate of accredita- § 493.551 General requirements for
tion as provided in subpart R of this laboratories.
part. If the laboratory requests a hear- (a) Applicability. CMS may deem a
ing within the time frame specified by laboratory to meet all applicable CLIA
HHS, it retains its certificate of ac- program requirements through accredi-
creditation or reissued certificate of tation by a private nonprofit accredita-
accreditation until a decision is made tion program (that is, grant deemed
by an administrative law judge as pro- status), or may exempt from CLIA pro-
vided in subpart R of this part, unless gram requirements all State licensed
HHS finds that conditions at the lab- or approved laboratories in a State
oratory pose an imminent and serious that has a State licensure program es-
risk to human health; and tablished by law, if the following condi-
(4) Suspension of payments under tions are met:
Medicare or Medicaid for those labora- (1) The requirements of the accredi-
tories receiving payments under the tation organization or State licensure
Medicare or Medicaid programs. program are equal to, or more strin-
gent than, the CLIA condition-level re-
FR 5224, Jan. 19, 1993] quirements specified in this part, and
the laboratory would meet the condi-
§ 493.63 Notification requirements for tion-level requirements if it were in-
laboratories issued a certificate of spected against these requirements.
accreditation. (2) The accreditation program or the
Laboratories issued a certificate of State licensure program meets the re-
accreditation must: quirements of this subpart and is ap-
(a) Notify HHS and the approved ac- proved by CMS.
creditation program within 30 days of (3) The laboratory authorizes the ap-
any changes in— proved accreditation organization or
(1) Ownership; State licensure program to release to
(2) Name; CMS all records and information re-
(3) Location; or quired and permits inspections as out-
(4) Director. lined in this part.
(b) Notify the approved accreditation (b) Meeting CLIA requirements by ac-
program no later than 6 months after creditation. A laboratory seeking to
performing any test or examination meet CLIA requirements through ac-
within a specialty or subspecialty area creditation by an approved accredita-
that is not included in the laboratory’s tion organization must do the fol-
accreditation, so that the accreditation lowing:
organization can determine compliance (1) Obtain a certificate of accredita-
and a new certificate of accreditation tion as required in subpart D of this
can be issued. part.
(c) Notify the accreditation program (2) Pay the applicable fees as re-
no later than 6 months after of any de- quired in subpart F of this part.
letions or changes in test methodolo- (3) Meet the proficiency testing (PT)
gies for any test or examination in- requirements in subpart H of this part.
634
(4) Authorize its PT organization to plies or reapplies to CMS for exemption

furnish to its accreditation organiza- from CLIA program requirements of li-
tion the results of the laboratory’s par- censed or approved laboratories within
ticipation in an approved PT program the State, must provide the following
for the purpose of monitoring the lab- information:
oratory’s PT and for making the an- (1) A detailed comparison of the indi-
nual PT results, along with explana- vidual accreditation, or licensure or
tory information required to interpret approval requirements with the com-
the PT results, available on a reason- parable condition-level requirements;
able basis, upon request of any person. that is, a crosswalk.
A laboratory that refuses to authorize (2) A detailed description of the in-
release of its PT results is no longer spection process, including the fol-
deemed to meet the condition-level re- lowing:
quirements and is subject to a full re- (i) Frequency of inspections.
view by CMS, in accordance with sub- (ii) Copies of inspection forms.
part Q of this part, and may be subject (iii) Instructions and guidelines.
to the suspension or revocation of its (iv) A description of the review and
certificate of accreditation under decision-making process of inspections.
§ 493.1840. (v) A statement concerning whether
(5) Authorize its accreditation orga- inspections are announced or unan-
nization to release to CMS or a CMS nounced.
agent the laboratory’s PT results that (vi) A description of the steps taken
constitute unsuccessful participation to monitor the correction of defi-
in an approved PT program, in accord- ciencies.
ance with the definition of ‘‘unsuccess- (3) A description of the process for
ful participation in an approved PT monitoring PT performance, including
program,’’ as specified in § 493.2 of this action to be taken in response to un-
part, when the laboratory has failed to successful participation in a CMS-ap-
achieve successful participation in an proved PT program.
approved PT program. (4) Procedures for responding to and
(6) Authorize its accreditation orga- for the investigation of complaints
nization to release to CMS a notifica- against its laboratories.
tion of the actions taken by the organi- (5) A list of all its current labora-
zation as a result of the unsuccessful tories and the expiration date of their
participation in a PT program within accreditation or licensure, as applica-
30 days of the initiation of the action. ble.
Based on this notification, CMS may (6) Procedures for making PT infor-
take an adverse action against a lab- mation available (under State con-
oratory that fails to participate suc- fidentiality and disclosure require-
cessfully in an approved PT program. ments, if applicable) including explana-
(c) Withdrawal of laboratory accredita- tory information required to interpret
tion. After an accreditation organiza- PT results, on a reasonable basis, upon
tion has withdrawn or revoked its ac- request of any person.
creditation of a laboratory, the labora- (b) CMS action on an application or re-
tory retains its certificate of accredita- application. If CMS receives an applica-
tion for 45 days after the laboratory re- tion or reapplication from an accredi-
ceives notice of the withdrawal or rev- tation organization, or State licensure
ocation of the accreditation, or the ef- program, CMS takes the following ac-
fective date of any action taken by tions:
CMS, whichever is earlier. (1) CMS determines if additional in-
formation is necessary to make a de-
§ 493.553 Approval process (applica- termination for approval or denial of
tion and reapplication) for accredi- the application and notifies the accred-
tation organizations and State li- itation organization or State to afford
censure programs. it an opportunity to provide the addi-
(a) Information required. An accredita- tional information.
tion organization that applies or re- (2) CMS may visit the accreditation
applies to CMS for deeming authority, organization or State licensure pro-
or a State licensure program that ap- gram offices to review and verify the
635
§ 493.555 42 CFR Ch. IV (10–1–17 Edition)
policies and procedures represented in (i) Accredited laboratories (or labora-

its application and other information, tories whose areas of specialty/sub-
including, but not limited to, review specialty testing have changed); or
and examination of documents and (ii) Licensed laboratories, including
interviews with staff. the specialty/subspecialty areas of test-
(3) CMS notifies the accreditation or- ing.
ganization or State licensure program (4) Notify each accredited or licensed
indicating whether CMS approves or laboratory within 10 days of CMS’s
denies the request for deeming author- withdrawal of the organization’s deem-
ity or exemption, respectively, and the ing authority or State’s exemption.
rationale for any denial. (5) Provide CMS with inspection
(c) Duration of approval. CMS ap- schedules, as requested, for validation
proval may not exceed 6 years. purposes.
(d) Withdrawal of application. The ac-
creditation organization or State licen- § 493.557 Additional submission re-
sure program may withdraw its appli- quirements.
cation at any time before official noti- (a) Specific requirements for accredita-
fication, specified at § 493.553(b)(3). tion organizations. In addition to the in-
formation specified in §§ 493.553 and
§ 493.555 Federal review of laboratory 493.555, as part of the approval and re-
requirements. view process, an accreditation organi-
CMS’s review of an accreditation or- zation applying or reapplying for deem-
ganization or State licensure program ing authority must also provide the
includes, but is not limited to, an eval- following:
uation of the following: (1) The specialty or subspecialty
(a) Whether the organization’s or areas for which the organization is re-
State’s requirements for laboratories questing deeming authority and its
are equal to, or more stringent than, mechanism for monitoring compliance
the condition-level requirements for with all requirements equivalent to
laboratories. condition-level requirements within
(b) The organization’s or State’s in- the scope of the specialty or sub-
spection process to determine the com- specialty areas.
parability of the full inspection and (2) A description of the organization’s
complaint inspection procedures and data management and analysis system
requirements to those of CMS, includ- with respect to its inspection and ac-
ing, but not limited to, inspection fre- creditation decisions, including the
quency and the ability to investigate kinds of routine reports and tables gen-
and respond to complaints against its erated by the systems.
laboratories. (3) Detailed information concerning
(c) The organization’s or State’s the inspection process, including, but
agreement with CMS that requires it not limited to the following:
to do the following: (i) The size and composition of indi-
(1) Notify CMS within 30 days of the vidual accreditation inspection teams.
action taken, of any laboratory that (ii) Qualifications, education, and ex-
has— perience requirements that inspectors
(i) Had its accreditation or licensure must meet.
suspended, withdrawn, revoked, or lim- (iii) The content and frequency of
ited; training provided to inspection per-
(ii) In any way been sanctioned; or sonnel, including the ability of the or-
(iii) Had any adverse action taken ganization to provide continuing edu-
against it. cation and training to inspectors.
(2) Notify CMS within 10 days of any (4) Procedures for removal or with-
deficiency identified in an accredited drawal of accreditation status for lab-
or CLIA-exempt laboratory if the defi- oratories that fail to meet the organi-
ciency poses an immediate jeopardy to zation’s standards.
the laboratory’s patients or a hazard to (5) A proposed agreement between
the general public. CMS and the accreditation organiza-

(3) Notify CMS, within 30 days, of all tion with respect to the notification re-
newly— quirements specified in § 493.555(c).
636
(6) Procedures for monitoring labora- reapplies for exemption from the CLIA
tories found to be out of compliance program, the State must do the fol-
with its requirements. (These moni- lowing:
toring procedures must be used only (1) Demonstrate to CMS that it has
when the accreditation organization enforcement authority and administra-
identifies noncompliance. If non- tive structures and resources adequate
compliance is identified through vali- to enforce its laboratory requirements.
dation inspections, CMS or a CMS (2) Permit CMS or a CMS agent to in-
agent monitors corrections, as author- spect laboratories in the State.
ized at § 493.565(d)). (3) Require laboratories in the State
(7) A demonstration of its ability to to submit to inspections by CMS or a
provide CMS with electronic data and CMS agent as a condition of licensure
reports in compatible code, including or approval.
the crosswalk specified in § 493.553(a)(1), (4) Agree to pay the cost of the vali-
that are necessary for effective valida- dation program administered in that
tion and assessment of the organiza- State as specified in §§ 493.645(a) and
tion’s inspection process. 493.646(b).
(8) A demonstration of its ability to (5) Take appropriate enforcement ac-
provide CMS with electronic data, in tion against laboratories found by CMS
compatible code, related to the adverse not to be in compliance with require-
actions resulting from PT results con- ments equivalent to CLIA require-
stituting unsuccessful participation in ments.
PT programs as well as data related to (6) Submit for Medicare and Medicaid
the PT failures, within 30 days of the payment purposes, a list of the special-
initiation of adverse action. ties and subspecialties of tests per-
(9) A demonstration of its ability to formed by each laboratory.
provide CMS with electronic data, in (7) Submit a written presentation
compatible code, for all accredited lab- that demonstrates the agency’s ability
oratories, including the area of spe- to furnish CMS with electronic data in
cialty or subspecialty. compatible code, including the cross-
(10) Information defining the ade- walk specified in § 493.553(a)(1).
quacy of numbers of staff and other re- (8) Submit a statement acknowl-
sources. edging that the State will notify CMS
(11) Information defining the organi- through electronic transmission of the
zation’s ability to provide adequate following:
funding for performing required inspec- (i) Any laboratory that has had its li-
tions. censure or approval revoked or with-
(12) Any facility-specific data, upon drawn or has been in any way sanc-
request by CMS, which includes, but is tioned by the State within 30 days of
not limited to, the following: taking the action.
(i) PT results that constitute unsuc- (ii) Changes in licensure or inspec-
cessful participation in a CMS-ap- tion requirements.
proved PT program. (iii) Changes in specialties or sub-
(ii) Notification of the adverse ac- specialties under which any licensed
tions or corrective actions imposed by laboratory in the State performs test-
the accreditation organization as a re- ing.
sult of unsuccessful PT participation. (9) Provide information for the re-
(13) An agreement to provide written view of the State’s enforcement proce-
notification to CMS at least 30 days in dures for laboratories found to be out
advance of the effective date of any of compliance with the State’s require-
proposed change in its requirements. ments.
(14) An agreement to disclose any (10) Submit information that dem-
laboratory’s PT results upon reason- onstrates the ability of the State to
able request by any person. provide CMS with the following:
(b) Specific requirements for a State li- (i) Electronic data and reports in
censure program. In addition to require- compatible code with the adverse or
ments in §§ 493.553 and 493.555, as part of corrective actions resulting from PT

the approval and review process, when results that constitute unsuccessful
a State licensure program applies or participation in PT programs.
637
§ 493.559 42 CFR Ch. IV (10–1–17 Edition)
(ii) Other data that CMS determines § 493.561 Denial of application or re-
are necessary for validation and assess- application.
ment of the State’s inspection process (a) Reconsideration of denial. (1) If
requirements. CMS denies a request for approval, an
(11) Agree to provide CMS with writ- accreditation organization or State li-
ten notification of any changes in its censure program may request, within
licensure/approval and inspection re- 60 days of the notification of denial,
quirements. that CMS reconsider its original appli-
(12) Agree to disclose any labora- cation or application for renewal, in
tory’s PT results in accordance with a accordance with part 488, subpart D.
State’s confidentiality requirements. (2) If the accreditation organization
(13) Agree to take the appropriate en- or State licensure program requests a
forcement action against laboratories reconsideration of CMS’s determina-
found by CMS not to be in compliance tion to deny its request for approval or
with requirements comparable to con- reapproval, it may not submit a new
dition-level requirements and report application until CMS issues a final re-
these enforcement actions to CMS. consideration determination.
(14) If approved, reapply to CMS
(b) Resubmittal of a request for ap-
every 2 years to renew its exempt sta-
proval—accreditation organization. An
tus and to renew its agreement to pay
accreditation organization may resub-
the cost of the CMS-administered vali-
mit a request for approval if a final re-
dation program in that State.
consideration determination is not
§ 493.559 Publication of approval of pending and the accreditation program
deeming authority or CLIA exemp- meets the following conditions:
tion. (1) It has revised its accreditation
(a) Notice of deeming authority or ex- program to address the rationale for
emption. CMS publishes a notice in the denial of its previous request.
FEDERAL REGISTER when it grants (2) It demonstrates that it can pro-
deeming authority to an accreditation vide reasonable assurance that its ac-
organization or exemption to a State credited facilities meet condition-level
licensure program. requirements.
(b) Contents of notice. The notice in- (3) It resubmits the application in its
cludes the following: entirety.
(1) The name of the accreditation or- (c) Resubmittal of request for ap-
ganization or State licensure program. proval—State licensure program. The
(2) For an accreditation organization: State licensure program may resubmit
(i) The specific specialty or sub- a request for approval if a final recon-
specialty areas for which it is granted sideration determination is not pend-
deeming authority. ing and it has taken the necessary ac-
(ii) A description of how the accredi- tion to address the rationale for any
tation organization provides reason- previous denial.
able assurance to CMS that a labora-
tory accredited by the organization § 493.563 Validation inspections—Basis
and focus.
meets CLIA requirements equivalent to
those in this part and would meet CLIA (a) Basis for validation inspection—(1)
requirements if the laboratory had not Laboratory with a certificate of accredita-
been granted deemed status, but had tion. (i) CMS or a CMS agent may con-
been inspected against condition-level duct an inspection of an accredited lab-
requirements. oratory that has been issued a certifi-
(3) For a State licensure program, a cate of accreditation on a representa-
description of how the laboratory re- tive sample basis or in response to a
quirements of the State are equal to, substantial allegation of noncompli-
or more stringent than, those specified ance.
in this part. (ii) CMS uses the results of these in-
(4) The basis for granting deeming spections to validate the accreditation
authority or exemption. organization’s accreditation process.

(5) The term of approval, not to ex- (2) Laboratory in a State with an ap-
ceed 6 years. proved State licensure program. (i) CMS
638
or a CMS agent may conduct an inspec- (1) A review of documents.

tion of any laboratory in a State with (2) An audit of meetings concerning
an approved State licensure program the accreditation process.
on a representative sample basis or in (3) Evaluation of accreditation in-
response to a substantial allegation of spection results and the accreditation
noncompliance. decision-making process.
(ii) The results of these inspections (4) Interviews with the accreditation
are used to validate the appropriate- organization’s staff.
ness of the exemption of that State’s (f) Onsite inspection of a State licensure
licensed or approved laboratories from program. An onsite inspection of a
CLIA program requirements. State licensure program office may in-
(b) Validation inspection conducted on clude, but is not limited to, the fol-
a representative sample basis. (1) If CMS lowing:
or a CMS agent conducts a validation (1) A review of documents.
inspection on a representative sample (2) An audit of meetings concerning
basis, the inspection is comprehensive, the licensure or approval process.
addressing all condition-level require-
(3) Evaluation of State inspection re-
ments, or it may be focused on a spe-
sults and the licensure or approval de-
cific condition-level requirement.
cision-making process.
(2) The number of laboratories sam-
pled is sufficient to allow a reasonable (4) Interviews with State employees.
estimate of the performance of the ac- § 493.565 Selection for validation in-
creditation organization or State. spection—laboratory responsibil-
(c) Validation inspection conducted in ities.
response to a substantial allegation of
noncompliance. (1) If CMS or a CMS A laboratory selected for a validation
agent conducts a validation inspection inspection must do the following:
in response to a substantial allegation (a) Authorize its accreditation orga-
of noncompliance, the inspection fo- nization or State licensure program, as
cuses on any condition-level require- applicable, to release to CMS or a CMS
ment that CMS determines to be reagent, on a confidential basis, a copy of
lated to the allegation. the laboratory’s most recent full, and
(2) If CMS or a CMS agent substan- any subsequent partial inspection.
tiates a deficiency and determines that (b) Authorize CMS or a CMS agent to
the laboratory is out of compliance conduct a validation inspection.
with any condition-level requirement, (c) Provide CMS or a CMS agent with
CMS or a CMS agent conducts a full access to all facilities, equipment, ma-
CLIA inspection. terials, records, and information that
(d) Inspection of operations and offices. CMS or a CMS agent determines have a
As part of the validation review proc- bearing on whether the laboratory is
ess, CMS may conduct an onsite in- being operated in accordance with the
spection of the operations and offices requirements of this part, and permit
to verify the following: CMS or a CMS agent to copy material
(1) The accreditation organization’s or require the laboratory to submit
representations and to assess the ac- material.
creditation organization’s compliance (d) If the laboratory possesses a valid
with its own policies and procedures. certificate of accreditation, authorize
(2) The State’s representations and to CMS or a CMS agent to monitor the
assess the State’s compliance with its correction of any deficiencies found
own policies and procedures, including through the validation inspection.
verification of State enforcement ac-
tions taken on the basis of validation § 493.567 Refusal to cooperate with
inspections performed by CMS or a validation inspection.
CMS agent. (a) Laboratory with a certificate of ac-
(e) Onsite inspection of an accreditation creditation. (1) A laboratory with a cer-
organization. An onsite inspection of an tificate of accreditation that refuses to
accreditation organization may in- cooperate with a validation inspection

clude, but is not limited to, the fol- by failing to comply with the require-
lowing: ments in § 493.565—
639
§ 493.569 42 CFR Ch. IV (10–1–17 Edition)
(i) Is subject to full review by CMS or § 493.571 Disclosure of accreditation,

a CMS agent, in accordance with this State and CMS validation inspec-
part; and tion results.
(ii) May be subject to suspension, (a) Accreditation organization inspec-
revocation, or limitation of its certifi- tion results. CMS may disclose accredi-
cate of accreditation under this part. tation organization inspection results
(2) A laboratory with a certificate of to the public only if the results are re-
accreditation is again deemed to meet lated to an enforcement action taken
the condition-level requirements by by the Secretary.
virtue of its accreditation when the fol- (b) State inspection results. Disclosure
lowing conditions exist: of State inspection results is the re-
(i) The laboratory withdraws any sponsibility of the approved State li-
prior refusal to authorize its accredita- censure program, in accordance with
tion organization to release a copy of State law.
the laboratory’s current accreditation (c) CMS validation inspection results.
CMS may disclose the results of all
inspection, PT results, or notification
validation inspections conducted by
of any adverse actions resulting from
CMS or its agent.
PT failure.
(ii) The laboratory withdraws any § 493.573 Continuing Federal oversight
prior refusal to allow a validation in- of private nonprofit accreditation
spection. organizations and approved State
(iii) CMS finds that the laboratory licensure programs.
meets all the condition-level require- (a) Comparability review. In addition
ments. to the initial review for determining
(b) CLIA-exempt laboratory. If a CLIA- equivalency of specified organization
exempt laboratory fails to comply with or State requirements to the com-
the requirements specified in § 493.565, parable condition-level requirements,
CMS notifies the State of the labora- CMS reviews the equivalency of re-
tory’s failure to meet the require- quirements in the following cases:
ments. (1) When CMS promulgates new con-
dition-level requirements.
§ 493.569 Consequences of a finding of (2) When CMS identifies an accredita-
noncompliance as a result of a vali- tion organization or a State licensure
dation inspection. program whose requirements are no
(a) Laboratory with a certificate of ac- longer equal to, or more stringent
creditation. If a validation inspection than, condition-level requirements.
results in a finding that the accredited (3) When an accreditation organiza-
laboratory is out of compliance with tion or State licensure program adopts
one or more condition-level require- new requirements.
ments, the laboratory is subject to— (4) When an accreditation organiza-
tion or State licensure program adopts
(1) The same requirements and sur-
changes to its inspection process, as re-
vey and enforcement processes applied
quired by § 493.575(b)(1), as applicable.
to laboratories that are not accredited
(5) Every 6 years, or sooner if CMS
and that are found out of compliance determines an earlier review is re-
following an inspection under this part; quired.
and (b) Validation review. Following the
(2) Full review by CMS, in accordance end of a validation review period, CMS
with this part; that is, the laboratory evaluates the validation inspection re-
is subject to the principal and alter- sults for each approved accreditation
native sanctions in § 493.1806. organization and State licensure pro-
(b) CLIA-exempt laboratory. If a vali- gram.
dation inspection results in a finding (c) Reapplication procedures. (1) Every
that a CLIA-exempt laboratory is out 6 years, or sooner, as determined by
of compliance with one or more condi- CMS, an approved accreditation orga-
tion-level requirements, CMS directs nization must reapply for continued

the State to take appropriate enforce- approval of deeming authority and a
ment action. State licensure program must reapply
640
for continued approval of a CLIA ex- § 493.575 Removal of deeming author-

emption. CMS provides notice of the ity or CLIA exemption and final de-
materials that must be submitted as termination review.
part of the reapplication procedure. (a) CMS review. CMS conducts a re-
(2) An accreditation organization or view of the following:
State licensure program that does not (1) A deeming authority review of an
meet the requirements of this subpart, accreditation organization’s program if
as determined through a comparability the comparability or validation review
or validation review, must furnish produces findings, as described at
CMS, upon request, with the reapplica- § 493.573. CMS reviews, as appropriate,
tion materials CMS requests. CMS es- the criteria described in §§ 493.555 and
tablishes a deadline by which the mate- 493.557(a) to reevaluate whether the ac-
rials must be submitted. creditation organization continues to
meet all these criteria.
(d) Notice. (1) CMS provides written
(2) An exemption review of a State’s
notice, as appropriate, to the following: licensure program if the comparability
(i) An accreditation organization in- or validation review produces findings,
dicating that its approval may be in as described at § 493.573. CMS reviews,
jeopardy if a comparability or valida- as appropriate, the criteria described in
tion review reveals that it is not meet- §§ 493.555 and 493.557(b) to reevaluate
ing the requirements of this subpart whether the licensure program con-
and CMS is initiating a review of the tinues to meet all these criteria.
accreditation organization’s deeming (3) A review of an accreditation orga-
authority. nization or State licensure program, at
(ii) A State licensure program indi- CMS’s discretion, if validation review
cating that its CLIA exemption may be findings, irrespective of the rate of dis-
in jeopardy if a comparability or vali- parity, indicate widespread or system-
dation review reveals that it is not atic problems in the organization’s ac-
meeting the requirements of this sub- creditation or State’s licensure process
part and that a review is being initi- that provide evidence that the require-
ated of the CLIA exemption of the ments, taken as a whole, are no longer
State’s laboratories. equivalent to CLIA requirements,
taken as a whole.
(2) The notice contains the following
(4) A review of the accreditation or-
information: ganization or State licensure program
(i) A statement of the discrepancies whenever validation inspection results
that were found as well as other re- indicate a rate of disparity of 20 per-
lated documentation. cent or more between the findings of
(ii) An explanation of CMS’s review the organization or State and those of
process on which the final determina- CMS or a CMS agent for the following
tion is based and a description of the periods:
possible actions, as specified in (i) One year for accreditation organi-
§ 493.575, that CMS may impose based zations.
on the findings from the comparability (ii) Two years for State licensure pro-
or validation review. grams.
(iii) A description of the procedures (b) CMS action after review. Following
available if the accreditation organiza- the review, CMS may take the fol-
tion or State licensure program, as ap- lowing action:
plicable, desires an opportunity to ex- (1) If CMS determines that the ac-
creditation organization or State has
plain or justify the findings made dur-
failed to adopt requirements equal to,
ing the comparability or validation re-
or more stringent than, CLIA require-
view.
ments, CMS may give a conditional ap-
(iv) The reapplication materials that proval for a probationary period of its
the accreditation organization or State deeming authority to an organization
licensure program must submit and the 30 days following the date of CMS’s de-
deadline for that submission. termination, or exempt status to a

State within 30 days of CMS’s deter-
mination, both not to exceed 1 year, to
641
§ 493.575 42 CFR Ch. IV (10–1–17 Edition)
afford the organization or State an op- (g) Withdrawal of approval-effect on

portunity to adopt equal or more strin- laboratory status—(1) Accredited labora-
gent requirements. tory. After CMS withdraws approval of
(2) If CMS determines that there are an accreditation organization’s deem-
widespread or systematic problems in ing authority, the certificate of accred-
the organization’s or State’s inspection itation of each affected laboratory con-
process, CMS may give conditional ap- tinues in effect for 60 days after it re-
proval during a probationary period, ceives notification of the withdrawal of
not to exceed 1 year, effective 30 days approval.
following the date of the determina- (2) CLIA-exempt laboratory. After CMS
tion. withdraws approval of a State licen-
(c) Final determination. CMS makes a sure program, the exempt status of
final determination as to whether the each licensed or approved laboratory in
organization or State continues to the State continues in effect for 60
meet the criteria described in this sub- days after a laboratory receives notifi-
part and issues a notice that includes cation from the State of the with-
the reasons for the determination to drawal of CMS’s approval of the pro-
the organization or State within 60 gram.
days after the end of any probationary (3) Extension. After CMS withdraws
period. This determination is based on approval of an accreditation organiza-
an evaluation of any of the following: tion or State licensure program, CMS
may extend the period for an addi-
(1) The most recent validation in-
tional 60 days for a laboratory if it de-
spection and review findings. To con-
termines that the laboratory sub-
tinue to be approved, the organization
mitted an application for accreditation
or State must meet the criteria of this
to an approved accreditation organiza-
subpart.
tion or an application for the appro-
(2) Facility-specific data, as well as
priate certificate to CMS or a CMS
other related information.
agent before the initial 60-day period
(3) The organization’s or State’s in- ends.
spection procedures, surveyors’ quali- (h) Immediate jeopardy to patients. (1)
fications, ongoing education, training, If at any time CMS determines that
and composition of inspection teams. the continued approval of deeming au-
(4) The organization’s accreditation thority of any accreditation organiza-
requirements, or the State’s licensure tion poses immediate jeopardy to the
or approval requirements. patients of the laboratories accredited
(d) Date of withdrawal of approval. by the organization, or continued ap-
CMS may withdraw its approval of the proval otherwise constitutes a signifi-
accreditation organization or State li- cant hazard to the public health, CMS
censure program, effective 30 days from may immediately withdraw the ap-
the date of written notice to the orga- proval of deeming authority for that
nization or State of this proposed ac- accreditation organization.
tion, if improvements acceptable to (2) If at any time CMS determines
CMS have not been made during the that the continued approval of a State
probationary period. licensure program poses immediate
(e) Continuation of validation inspec- jeopardy to the patients of the labora-
tions. The existence of any validation tories in that State, or continued ap-
review, probationary status, or any proval otherwise constitutes a signifi-
other action, such as a deeming au- cant hazard to the public health, CMS
thority review, by CMS does not affect may immediately withdraw the ap-
or limit the conduct of any validation proval of that State licensure program.
inspection. (i) Failure to pay fees. CMS withdraws
(f) Federal Register notice. CMS pub- the approval of a State licensure pro-
lishes a notice in the FEDERAL REG- gram if the State fails to pay the appli-
ISTER containing a justification for re- cable fees, as specified in §§ 493.645(a)
moving the deeming authority from an and 493.646(b).
accreditation organization, or the (j) State refusal to take enforcement ac-

CLIA-exempt status of a State licen- tion. (1) CMS may withdraw approval of
sure program. a State licensure program if the State
642
refuses to take enforcement action administering the laboratory certifi-

against a laboratory in that State cation program under section 353 of the
when CMS determines it to be nec- PHS Act.
essary. (1) For registration certificates and
(2) A laboratory that is in a State in certificates of compliance, the costs in-
which CMS has withdrawn program ap- clude issuing the certificates, col-
proval is subject to the same require- lecting the fees, evaluating and moni-
ments and survey and enforcement toring proficiency testing programs,
processes that are applied to a labora- evaluating which procedures, tests or
tory that is not exempt from CLIA re- examinations meet the criteria for in-
quirements. clusion in the appropriate complexity
(k) Request for reconsideration. Any category, and implementing section 353
accreditation organization or State of the PHS Act.
that is dissatisfied with a determina- (2) For a certificate of waiver, the
tion to withdraw approval of its deem- costs include issuing the certificate,
ing authority or remove approval of its collecting the fees, determining if a
State licensure program, as applicable, certificate of waiver should be issued,
may request that CMS reconsider the evaluating which tests qualify for in-
determination, in accordance with sub- clusion in the waived category, and
part D of part 488. other direct administrative costs.
(3) For a certificate for PPM proce-
Subpart F—General Administration dures, the costs include issuing the cer-
tificate, collecting the fees, deter-
SOURCE: 57 FR 7138, 7213, Feb. 28, 1992, un- mining if a certificate for PPM proce-
less otherwise noted. dures should be issued, evaluating
which procedures meet the criteria for
§ 493.602 Scope of subpart. inclusion in the subcategory of PPM
This subpart sets forth the method- procedures, and other direct adminis-
ology for determining the amount of trative costs.
the fees for issuing the appropriate cer- (4) For a certificate of accreditation,
tificate, and for determining compli- the costs include issuing the certifi-
ance with the applicable standards of cate, collecting the fees, evaluating the
the Public Health Service Act (the PHS programs of accrediting bodies, and
Act) and the Federal validation of ac- other direct administrative costs.
credited laboratories and of CLIA-ex- (b) Fee amount. The fee amount is set
empt laboratories. annually by HHS on a calendar year
[60 FR 20047, Apr. 24, 1995]
basis and is based on the category of
test complexity, or on the category of
§ 493.606 Applicability of subpart. test complexity and schedules or
ranges of annual laboratory test vol-
The rules of this subpart are applica-
ume (excluding waived tests and tests
ble to those laboratories specified in
performed for quality control, quality
§ 493.3.
assurance, and proficiency testing pur-
[58 FR 5212, Jan. 19, 1993] poses) and specialties tested, with the
amounts of the fees in each schedule
§ 493.638 Certificate fees. being a function of the costs for all as-
(a) Basic rule. Laboratories must pay pects of general administration of
a fee for the issuance of a registration CLIA as set forth in § 493.649 (b) and (c).
certificate, certificate for PPM proce- This fee is assessed and payable at
dures, certificate of waiver, certificate least biennially. The methodology used
of accreditation, or a certificate of to determine the amount of the fee is
compliance, as applicable. Laboratories found in § 493.649. The amount of the fee
must also pay a fee to reapply for a applicable to the issuance of the reg-
certificate for PPM procedures, certifi- istration certificate or the issuance or
cate of waiver, certificate of accredita- renewal of the certificate for PPM pro-
tion, or a certificate of compliance. cedures, certificate of waiver, certifi-
The total of fees collected by HHS cate of accreditation, or certificate of

under the laboratory program must be compliance is the amount in effect at
sufficient to cover the general costs of the time the application is received.
643
§ 493.639 42 CFR Ch. IV (10–1–17 Edition)
Upon receipt of an application for a must pay a fee to cover the cost of de-
certificate, HHS or its designee notifies termining program compliance. Lab-
the laboratory of the amount of the re- oratories issued a certificate for PPM
quired fee for the requested certificate. procedures, certificate of waiver, or a
[60 FR 20047, Apr. 24, 1995]
certificate of accreditation are not sub-
ject to this fee for routine inspections.
§ 493.639 Fee for revised certificate. (b) Costs included in the fee. Included
(a) If, after a laboratory is issued a in the fee for determining program
registration certificate, it changes its compliance is the cost of evaluating
name or location, the laboratory must qualifications of personnel; monitoring
pay a fee to cover the cost of issuing a proficiency testing; conducting onsite
revised registration certificate. The fee inspections; documenting deficiencies;
for the revised registration certificate evaluating laboratories’ plans to cor-
is based on the cost to issue the revised rect deficiencies; and necessary admin-
certificate to the laboratory. istrative costs. HHS sets the fee
(b) A laboratory must pay a fee to amounts annually on a calendar year
cover the cost of issuing a revised cer- basis. Laboratories are inspected bien-
tificate in any of the following cir- nially; therefore, fees are assessed and
cumstances: payable biennially. If additional ex-
(1) The fee for issuing an appropriate penses are incurred to conduct follow
revised certificate is based on the cost up visits to verify correction of defi-
to issue the revised certificate to the ciencies, to impose sanctions, and/or
laboratory as follows: for surveyor preparation for and at-
(i) If a laboratory with a certificate tendance at ALJ hearings, HHS as-
of waiver wishes to perform tests in ad- sesses an additional fee to include
dition to those listed in § 493.15(c) as these costs. The additional fee is based
waived tests, it must, as set forth in on the actual resources and time nec-
§ 493.638, pay an additional fee for the essary to perform the activities.
appropriate certificate to cover the ad- (c) Classification of laboratories that re-
ditional testing. quire inspection for purpose of deter-
(ii) If a laboratory with a certificate mining amount of fee. (1) There are ten
for PPM procedures wishes to perform classifications (schedules) of labora-
tests in addition to those specified as tories for the purpose of determining
PPM procedures or listed in § 493.15(c) the fee amount a laboratory is as-
as waived tests, it must, as set forth in sessed. Each laboratory is placed into
§ 493.638, pay an additional fee for the one of the ten following schedules
appropriate certificate to cover the ad- based on the laboratory’s scope and
ditional testing. volume of testing (excluding tests per-
(2) A laboratory must pay a fee to formed for quality control, quality as-
cover the cost of issuing a revised cer- surance, and proficiency testing pur-
tificate when— poses).
(i) A laboratory changes its name, lo- (i) (A) Schedule A Low Volume. The
cation, or its director; or laboratory performs not more than
(ii) A laboratory deletes services or 2,000 laboratory tests annually.
wishes to add services and requests (B) Schedule A. The laboratory per-
that its certificate be changed. (An ad- forms tests in no more than 3 special-
ditional fee is also required under ties of service with a total annual vol-
§ 493.643(d) if it is necessary to deter- ume of more than 2,000 but not more
mine compliance with additional re- than 10,000 laboratory tests.
quirements.) (ii) Schedule B. The laboratory per-
[57 FR 7213, Feb. 28, 1992, as amended at 60 forms tests in at least 4 specialties of
FR 20047, Apr. 24, 1995] service with a total annual volume of
not more than 10,000 laboratory tests.
§ 493.643 Fee for determination of pro- (iii) Schedule C. The laboratory per-
gram compliance. forms tests in no more 3 specialties of
(a) Fee requirement. In addition to the service with a total annual volume of
fee required under § 493.638, a labora- more than 10,000 but not more than
tory subject to routine inspections 25,000 laboratory tests.
644
(iv) Schedule D. The laboratory per- (C) Toxicology.

forms tests in at least 4 specialties (D) Urinalysis.
with a total annual volume of more (iv) The specialty of Hematology.
than 10,000 but not more than 25,000 (v) The specialty of
laboratory tests. Immunohematology, which includes
(v) Schedule E. The laboratory per- one or more of the following sub-
forms more than 25,000 but not more specialties:
than 50,000 laboratory tests annually. (A) ABO grouping and Rh typing.
(vi) Schedule F. The laboratory per-
(B) Unexpected antibody detection.
forms more than 50,000 but not more
than 75,000 laboratory tests annually. (C) Compatibility testing.
(vii) Schedule G. The laboratory per- (D) Unexpected antibody identifica-
forms more than 75,000 but not more tion.
than 100,000 laboratory tests annually. (vi) The specialty of Pathology,
(viii) Schedule H. The laboratory per- which includes the following sub-
forms more than 100,000 but not more specialties:
than 500,000 laboratory tests annually. (A) Cytology.
(ix) Schedule I. The laboratory per- (B) Histopathology.
forms more than 500,000 but not more (C) Oral pathology.
than 1,000,000 laboratory tests annu- (vii) The specialty of Radiobioassay.
ally. (viii) The specialty of
(x) Schedule J. The laboratory per- Histocompatibility.
forms more than 1,000,000 laboratory (ix) The specialty of Clinical Cyto-
tests annually. genetics.
(2) For purposes of determining a lab-
(d) Additional fees. (1) If after a cer-
oratory’s classification under this sec-
tificate of compliance is issued, a lab-
tion, a test is a procedure or examina-
oratory adds services and requests that
tion for a single analyte. (Tests per-
formed for quality control, quality as- its certificate be upgraded, the labora-
surance, and proficiency testing are ex- tory must pay an additional fee if, in
cluded from the laboratory’s total an- order to determine compliance with ad-
nual volume). Each profile (that is, ditional requirements, it is necessary
group of tests) is counted as the num- to conduct an inspection, evaluate per-
ber of separate procedures or examina- sonnel, or monitor proficiency testing
tions; for example, a chemistry profile performance. The additional fee is
consisting of 18 tests is counted as 18 based on the actual resources and time
separate procedures or tests. necessary to perform the activities.
(3) For purposes of determining a lab- HHS revokes the laboratory’s certifi-
oratory’s classification under this sec- cate for failure to pay the compliance
tion, the specialties and subspecialties determination fee.
of service for inclusion are: (2) If it is necessary to conduct a
(i) The specialty of Microbiology, complaint investigation, impose sanc-
which includes one or more of the fol- tions, or conduct a hearing, HHS as-
lowing subspecialties: sesses the laboratory holding a certifi-
(A) Bacteriology. cate of compliance a fee to cover the
(B) Mycobacteriology. cost of these activities. If a complaint
(C) Mycology. investigation results in a complaint
(D) Parasitology. being unsubstantiated, or if an HHS ad-
(E) Virology. verse action is overturned at the con-
(ii) The specialty of Serology, which clusion of the administrative appeals
includes one or more of the following process, the government’s costs of
subspecialties: these activities are not imposed upon
(A) Syphilis Serology. the laboratory. Costs for these activi-
(B) General immunology ties are based on the actual resources
(iii) The specialty of Chemistry, and time necessary to perform the ac-
which includes one or more of the fol- tivities and are not assessed until after
lowing subspecialties: the laboratory concedes the existence

(A) Routine chemistry. of deficiencies or an ALJ rules in favor
(B) Endocrinology. of HHS. HHS revokes the laboratory’s
645
§ 493.645 42 CFR Ch. IV (10–1–17 Edition)
certificate of compliance for failure to tory a fee to cover the cost of these ac-
pay the assessed costs. tivities. Costs are based on the actual
resources and time necessary to per-
[57 FR 7138, 7213, Feb. 28, 1992, as amended at
60 FR 20047, Apr. 24, 1995; 68 FR 3702, Jan. 24, form the activities and are not assessed
2003] until after the laboratory concedes the
existence of deficiencies or an ALJ
§ 493.645 Additional fee(s) applicable rules in favor of HHS. HHS revokes the
to approved State laboratory pro- laboratory’s certificate for failure to
grams and laboratories issued a pay the assessed costs. If a complaint
certificate of accreditation, certifi- investigation results in a complaint
cate of waiver, or certificate for being unsubstantiated, or if an HHS ad-
PPM procedures.
verse action is overturned at the con-
(a) Approved State laboratory programs. clusion of the administrative appeals
State laboratory programs approved by process, the costs of these activities
HHS are assessed a fee for the fol- are not imposed upon the laboratory.
lowing:
[60 FR 20047, Apr. 24, 1995]
(1) Costs of Federal inspections of
laboratories in that State (that is, § 493.646 Payment of fees.
CLIA-exempt laboratories) to verify
that standards are being enforced in an (a) Except for CLIA-exempt labora-
appropriate manner. tories, all laboratories are notified in
(2) Costs incurred for investigations writing by HHS or its designee of the
of complaints against the State’s appropriate fee(s) and instructions for
CLIA-exempt laboratories if the com- submitting the fee(s), including the due
plaint is substantiated. date for payment and where to make
(3) Costs of the State’s prorata share payment. The appropriate certificate is
of general overhead to develop and im- not issued until the applicable fees
plement CLIA. have been paid.
(b) Accredited laboratories. (1) In addi- (b) For State-exempt laboratories,
tion to the certificate fee, a laboratory HHS estimates the cost of conducting
that is issued a certificate of accredita- validation surveys within the State for
tion is also assessed a fee to cover the a 2-year period. HHS or its designee no-
cost of evaluating individual labora- tifies the State by mail of the appro-
tories to determine overall whether an priate fees, including the due date for
accreditation organization’s standards payment and the address of the United
and inspection policies are equivalent States Department of Treasury des-
to the Federal program. All accredited ignated commercial bank to which
laboratories share in the cost of these payment must be made. In addition, if
inspections. These costs are the same complaint investigations are conducted
as those that are incurred when in- in laboratories within these States and
specting nonaccredited laboratories. are substantiated, HHS bills the
(2) If a laboratory issued a certificate State(s) the costs of the complaint in-
of accreditation has been inspected and vestigations.
followup visits are necessary because of [57 FR 7138, 7213, Feb. 28, 1992, as amended at
identified deficiencies, HHS assesses 60 FR 20048, Apr. 24, 1995]
the laboratory a fee to cover the cost
of these visits. The fee is based on the § 493.649 Methodology for determining
actual resources and time necessary to fee amount.
perform the followup visits. HHS re- (a) General rule. The amount of the
vokes the laboratory’s certificate of fee in each schedule for compliance de-
accreditation for failure to pay the as- termination inspections is based on the
sessed fee. average hourly rate (which includes
(c) If, in the case of a laboratory that the costs to perform the required ac-
has been issued a certificate of accredi- tivities and necessary administration
tation, certificate of waiver, or certifi- costs) multiplied by the average num-
cate for PPM procedures, it is nec- ber of hours required or, if activities
essary to conduct a complaint inves- are performed by more than one of the
tigation, impose sanctions, or conduct entities listed in paragraph (b) of this
a hearing, HHS assesses that labora- section, the sum of the products of the
646
applicable hourly rates multiplied by tractors is the average hourly rate es-
the average number of hours required tablished for contractor assistance
by the entity to perform the activity. based on an independent government
The fee for issuance of the registration cost estimate for the required work-
certificate or certificate of compliance load. This rate includes the cost of con-
is based on the laboratory’s scope and tractor support to provide proficiency
volume of testing. testing programs to laboratories that
(b) Determining average hourly rates do not participate in an approved pro-
used in fee schedules. Three different en- ficiency testing program, provide spe-
tities perform activities related to the cialized assistance in the evaluation of
issuance or reissuance of any certifi- laboratory performance in an approved
cate. HHS determines the average proficiency testing program, perform
hourly rates for the activities of each assessments of cytology testing labora-
of these entities. tories, conduct special studies, bill and
(1) State survey agencies. The fol- collect fees, issue certificates, estab-
lowing costs are included in deter- lish accounting, monitoring and re-
mining an average hourly rate for the porting systems, and assist with nec-
activities performed by State survey essary surveyor training.
agencies: (c) Determining number of hours. The
(i) The costs incurred by the State average number of hours used to deter-
survey agencies in evaluating per- mine the overall fee in each schedule is
sonnel qualifications and monitoring HHS’s estimate, based on historical ex-
each laboratory’s participation in an perience, of the average time needed by
approved proficiency testing program. each entity to perform the activities
The cost of onsite inspections and mon- for which it is responsible.
itoring activities is the hourly rate de-
rived as a result of an annual budget [57 FR 7138, 7213, Feb. 28, 1992, as amended at
negotiation process with each State. 60 FR 20048, Apr. 24, 1995]
The hourly rate encompasses salary
costs (as determined by each State’s Subpart G [Reserved]
civil service pay scale) and fringe ben-
efit costs to support the required num- Subpart H—Participation in Pro-
ber of State inspectors, management ficiency Testing for Labora-
and direct support staff.
(ii) Travel costs necessary to comply
tories Performing Nonwaived
with each State’s administrative re- Testing
quirements and other direct costs such
as equipment, printing, and supplies. SOURCE: 57 FR 7146, Feb. 28, 1992, unless
These costs are established based on otherwise noted.
historical State requirements.
(iii) Indirect costs as negotiated by § 493.801 Condition: Enrollment and
HHS. testing of samples.
(2) Federal agencies. The hourly rate Each laboratory must enroll in a pro-
for activities performed by Federal ficiency testing (PT) program that
agencies is the most recent average meets the criteria in subpart I of this
hourly cost to HHS to staff and support part and is approved by HHS. The lab-
a full time equivalent employee. In- oratory must enroll in an approved
cluded in this cost are salary and program or programs for each of the
fringe benefit costs, necessary adminis- specialties and subspecialties for which
trative costs, such as printing, train- it seeks certification. The laboratory
ing, postage, express mail, supplies, must test the samples in the same
equipment, computer system and build- manner as patients’ specimens. For
ing service charges associated with laboratories subject to 42 CFR part 493
support services provided by organiza- published on March 14, 1990 (55 FR 9538)
tional components such as a computer prior to September 1, 1992, the rules of
center, and any other oversight activi- this subpart are effective on September
ties necessary to support the program. 1, 1992. For all other laboratories, the
(3) HHS contractors. The hourly rate rules of this subpart are effective Janu-
for activities performed by HHS con- ary 1, 1994.
647
§ 493.801 42 CFR Ch. IV (10–1–17 Edition)
(a) Standard; Enrollment. The laboratory director must attest to the rou-
tory must— tine integration of the samples into the
(1) Notify HHS of the approved pro- patient workload using the labora-
gram or programs in which it chooses tory’s routine methods.
to participate to meet proficiency test- (2) The laboratory must test samples
ing requirements of this subpart. the same number of times that it rou-
(2)(i) Designate the program(s) to be tinely tests patient samples.
used for each specialty, subspecialty, (3) Laboratories that perform tests
and analyte or test to determine com- on proficiency testing samples must
pliance with this subpart if the labora- not engage in any inter-laboratory
tory participates in more than one pro- communications pertaining to the re-
ficiency testing program approved by sults of proficiency testing sample(s)
CMS; and until after the date by which the lab-
(ii) For those tests performed by the oratory must report proficiency testing
laboratory that are not included in results to the program for the testing
subpart I of this part, a laboratory event in which the samples were sent.
must establish and maintain the accu- Laboratories with multiple testing
racy of its testing procedures, in ac- sites or separate locations must not
cordance with § 493.1236(c)(1). participate in any communications or
(3) For each specialty, subspecialty discussions across sites/locations con-
and analyte or test, participate in one cerning proficiency testing sample re-
approved proficiency testing program sults until after the date by which the
or programs, for one year before desig- laboratory must report proficiency
nating a different program and must testing results to the program.
notify CMS before any change in des- (4) The laboratory must not send pro-
ignation; and ficiency testing samples or portions of
(4) Authorize the proficiency testing proficiency testing samples to another
program to release to HHS all data re- laboratory for any analysis for which it
quired to— is certified to perform in its own lab-
(i) Determine the laboratory’s com- oratory. Any laboratory that CMS de-
pliance with this subpart; and termines intentionally referred a pro-
(ii) Make PT results available to the ficiency testing sample to another lab-
public as required in section 353(f)(3)(F) oratory for analysis may have its cer-
of the Public Health Service Act. tification revoked for at least 1 year. If
(b) Standard: Testing of proficiency CMS determines that a proficiency
testing samples. The laboratory must ex- testing sample was referred to another
amine or test, as applicable, the pro- laboratory for analysis, but the re-
ficiency testing samples it receives quested testing was limited to reflex,
from the proficiency testing program distributive, or confirmatory testing
in the same manner as it tests patient that, if the sample were a patient spec-
specimens. This testing must be con- imen, would have been in full conform-
ducted in conformance with paragraph ance with written, legally accurate and
(b)(4) of this section. If the laboratory’s adequate standard operating proce-
patient specimen testing procedures dures for the laboratory’s testing of pa-
would normally require reflex, dis- tient specimens, and if the proficiency
tributive, or confirmatory testing at testing referral is not a repeat pro-
another laboratory, the laboratory ficiency testing referral, CMS will con-
should test the proficiency testing sider the referral to be improper and
sample as it would a patient specimen subject to alternative sanctions in ac-
up until the point it would refer a pa- cordance with § 493.1804(c), but not in-
tient specimen to a second laboratory tentional. Any laboratory that receives
for any form of further testing. a proficiency testing sample from an-
(1) The samples must be examined or other laboratory for testing must no-
tested with the laboratory’s regular pa- tify CMS of the receipt of that sample
tient workload by personnel who rou- regardless of whether the referral was
tinely perform the testing in the lab- made for reflex or confirmatory test-
oratory, using the laboratory’s routine ing, or any other reason.

methods. The individual testing or ex- (5) The laboratory must document
amining the samples and the labora- the handling, preparation, processing,
648
examination, and each step in the test- rect the problem identified by the un-
ing and reporting of results for all pro- successful proficiency testing perform-
ficiency testing samples. The labora- ance.
tory must maintain a copy of all (3) The laboratory has a poor compli-
records, including a copy of the pro- ance history.
ficiency testing program report forms
used by the laboratory to record pro- [57 FR 7146, Feb. 28, 1992, as amended at 60
ficiency testing results including the FR 20048, Apr. 24, 1995; 63 FR 26737, May 14,
1998; 68 FR 3702, Jan. 24, 2003]
attestation statement provided by the
PT program, signed by the analyst and § 493.807 Condition: Reinstatement of
the laboratory director, documenting laboratories performing nonwaived
that proficiency testing samples were testing.
tested in the same manner as patient
specimens, for a minimum of two years (a) If a laboratory’s certificate is sus-
from the date of the proficiency testing pended or limited or its Medicare or
event. Medicaid approval is cancelled or its
(6) PT is required for only the test Medicare or Medicaid payments are
system, assay, or examination used as suspended because it fails to partici-
the primary method for patient testing pate successfully in proficiency testing
during the PT event. for one or more specialties, subspecial-
ties, analyte or test, or voluntarily
withdraws its certification under CLIA
FR 5228, Jan. 19, 1993; 68 FR 3702, Jan. 24,
2003; 79 FR 27157, May 12, 2014] for the failed specialty, subspecialty,
or analyte, the laboratory must then
§ 493.803 Condition: Successful partici- demonstrate sustained satisfactory
pation. performance on two consecutive pro-
(a) Each laboratory performing non- ficiency testing events, one of which
waived testing must successfully par- may be on site, before CMS will con-
ticipate in a proficiency testing pro- sider it for reinstatement for certifi-
gram approved by CMS, if applicable, cation and Medicare or Medicaid ap-
as described in subpart I of this part proval in that specialty, subspecialty,
for each specialty, subspecialty, and analyte or test.
analyte or test in which the laboratory (b) The cancellation period for Medi-
is certified under CLIA. care and Medicaid approval or period
(b) Except as specified in paragraph for suspension of Medicare or Medicaid
(c) of this section, if a laboratory fails payments or suspension or limitation
to participate successfully in proof certification under CLIA for the
ficiency testing for a given specialty, failed specialty, subspecialty, or
subspecialty, analyte or test, as de- analyte or test is for a period of not
fined in this section, or fails to take re- less than six months from the date of
medial action when an individual fails cancellation, limitation or suspension
gynecologic cytology, CMS imposes of the CLIA certificate.
sanctions, as specified in subpart R of
this part. [58 FR 5228, Jan. 19, 1993, as amended at 60
(c) If a laboratory fails to perform FR 20048, Apr. 24, 1995]
successfully in a CMS-approved pro-
ficiency testing program, for the ini- PROFICIENCY TESTING BY SPECIALTY AND
tial unsuccessful performance, CMS SUBSPECIALTY FOR LABORATORIES
may direct the laboratory to undertake PERFORMING TESTS OF MODERATE
training of its personnel or to obtain COMPLEXITY (INCLUDING THE SUB-
CATEGORY), HIGH COMPLEXITY, OR ANY
technical assistance, or both, rather
than imposing alternative or principle COMBINATION OF THESE TESTS
sanctions except when one or more of
§ 493.821 Condition: Microbiology.
the following conditions exists:
(1) There is immediate jeopardy to The specialty of microbiology in-
patient health and safety. cludes, for purposes of proficiency test-
(2) The laboratory fails to provide ing, the subspecialties of bacteriology,

CMS or a CMS agent with satisfactory mycobacteriology, mycology,
evidence that it has taken steps to cor- parasitology and virology.
649
§ 493.823 42 CFR Ch. IV (10–1–17 Edition)
§ 493.823 Standard; Bacteriology. to those laboratories failing to partici-

pate in a testing event only if—
(a) Failure to attain an overall test-
(1) Patient testing was suspended
ing event score of at least 80 percent is
during the time frame allotted for test-
unsatisfactory performance.
ing and reporting proficiency testing
(b) Failure to participate in a testing
results;
event is unsatisfactory performance
(2) The laboratory notifies the in-
and results in a score of 0 for the test-
specting agency and the proficiency
ing event. Consideration may be given
testing program within the time frame
to those laboratories failing to partici-
for submitting proficiency testing re-
sults of the suspension of patient test-
(1) Patient testing was suspended ing and the circumstances associated
during the time frame allotted for test- with failure to perform tests on pro-
ing and reporting proficiency testing ficiency testing samples; and
results; (3) The laboratory participated in the
(2) The laboratory notifies the in- previous two proficiency testing
specting agency and the proficiency events.
testing program within the time frame (c) Failure to return proficiency test-
for submitting proficiency testing re- ing results to the proficiency testing
sults of the suspension of patient test- program within the time frame speci-
ing and the circumstances associated fied by the program is unsatisfactory
with failure to perform tests on pro- performance and results in a score of 0
ficiency testing samples; and for the testing event.
(3) The laboratory participated in the (d)(1) For any unsatisfactory testing
previous two proficiency testing event for reasons other than a failure
events. to participate, the laboratory must un-
(c) Failure to return proficiency test- dertake appropriate training and em-
ing results to the proficiency testing ploy the technical assistance necessary
program within the time frame speci- to correct problems associated with a
fied by the program is unsatisfactory proficiency testing failure.
performance and results in a score of 0 (2) Remedial action must be taken
for the testing event. and documented, and the documenta-
(d)(1) For any unsatisfactory testing tion must be maintained by the labora-
event for reasons other than a failure tory for two years from the date of par-
to participate, the laboratory must un- ticipation in the proficiency testing
dertake appropriate training and em- event.
ploy the technical assistance necessary (e) Failure to achieve an overall test-
to correct problems associated with a ing event score of satisfactory perform-
proficiency testing failure. ance for two consecutive testing events
(2) Remedial action must be taken or two out of three consecutive testing
and documented, and the documenta- events is unsuccessful performance.
tion must be maintained by the labora-
tory for two years from the date of par- § 493.827 Standard; Mycology.
ticipation in the proficiency testing (a) Failure to attain an overall test-
event. ing event score of at least 80 percent is
(e) Failure to achieve an overall test- unsatisfactory performance.
ing event score of satisfactory perform- (b) Failure to participate in a testing
ance for two consecutive testing events event is unsatisfactory performance
or two out of three consecutive testing and results in a score of 0 for the test-
events is unsuccessful performance. ing event. Consideration may be given
§ 493.825 Standard; Mycobacteriology. pate in a testing event only if—
(a) Failure to attain an overall test- (1) Patient testing was suspended
ing event score of at least 80 percent is during the time frame allotted for test-
unsatisfactory performance. ing and reporting proficiency testing
(b) Failure to participate in a testing results;
event is unsatisfactory performance (2) The laboratory notifies the in-

and results in a score of 0 for the test- specting agency and the proficiency
ing event. Consideration may be given testing program within the time frame
650
for submitting proficiency testing re- (c) Failure to return proficiency test-
sults of the suspension of patient testing results to the proficiency testing
ing and the circumstances associated program within the time frame speci-
with failure to perform tests on pro- fied by the program is unsatisfactory
ficiency testing samples; and performance and results in a score of 0
(3) The laboratory participated in the for the testing event.
previous two proficiency testing (d)(1) For any unsatisfactory testing
events. event for reasons other than a failure
(c) Failure to return proficiency test- to participate, the laboratory must un-
ing results to the proficiency testing dertake appropriate training and em-
program within the time frame speci- ploy the technical assistance necessary
fied by the program is unsatisfactory to correct problems associated with a
performance and results in a score of 0 proficiency testing failure.
for the testing event. (2) Remedial action must be taken
(d)(1) For any unsatisfactory testing and documented, and the documenta-
event for reasons other than a failure tion must be maintained by the labora-
to participate, the laboratory must un- tory for two years from the date of par-
dertake appropriate training and em- ticipation in the proficiency testing
ploy the technical assistance necessary event.
to correct problems associated with a (e) Failure to achieve an overall test-
proficiency testing failure. ing event score of satisfactory perform-
(2) Remedial action must be taken ance for two consecutive testing events
and documented, and the documenta- or two out of three consecutive testing
tion must be maintained by the labora- events is unsuccessful performance.
tory for two years from the date of par-
ticipation in the proficiency testing § 493.831 Standard; Virology.
event. (a) Failure to attain an overall test-
(e) Failure to achieve an overall testing event score of at least 80 percent is
ing event score of satisfactory perform- unsatisfactory performance.
ance for two consecutive testing events (b) Failure to participate in a testing
or two out of three consecutive testing event is unsatisfactory performance
events is unsuccessful performance. and results in a score of 0 for the test-
ing event. Consideration may be given
§ 493.829 Standard; Parasitology. to those laboratories failing to partici-
(a) Failure to attain an overall test- pate in a testing event only if—
ing event score of at least 80 percent is (1) Patient testing was suspended
unsatisfactory performance. during the time frame allotted for test-
(b) Failure to participate in a testing ing and reporting proficiency testing
event is unsatisfactory performance results;
and results in a score of 0 for the test- (2) The laboratory notifies the in-
ing event. Consideration may be given specting agency and the proficiency
to those laboratories failing to partici- testing program within the time frame
pate in a testing event only if— for submitting proficiency testing re-
(1) Patient testing was suspended sults of the suspension of patient test-
during the time frame allotted for testing and the circumstances associated
ing and reporting proficiency testing with failure to perform tests on pro-
results; ficiency testing samples; and
(2) The laboratory notifies the in- (3) The laboratory participated in the
specting agency and the proficiency previous two proficiency testing
testing program within the time frame events.
for submitting proficiency testing re- (c) Failure to return proficiency test-
sults of the suspension of patient testing results to the proficiency testing
ing and the circumstances associated program within the time frame speci-
with failure to perform tests on pro- fied by the program is unsatisfactory
ficiency testing samples; and performance and results in a score of 0
(3) The laboratory participated in the for the testing event.

previous two proficiency testing (d)(1) For any unsatisfactory testing
events. event for reasons other than a failure
651
§ 493.833 42 CFR Ch. IV (10–1–17 Edition)
to participate, the laboratory must un- to participate, the laboratory must un-
dertake appropriate training and em- dertake appropriate training and em-
ploy the technical assistance necessary ploy the technical assistance necessary
to correct problems associated with a to correct problems associated with a
proficiency testing failure. proficiency testing failure.
(2) For any unsatisfactory testing (2) For any unacceptable testing
events, remedial action must be taken event score, remedial action must be
and documented, and the documenta- taken and documented, and the docu-
tion must be maintained by the labora- mentation must be maintained by the
tory for two years from the date of par- laboratory for two years from the date
ticipation in the proficiency testing of participation in the proficiency test-
event. ing event.
(e) Failure to achieve an overall test-
ing event score of satisfactory perform-
ance for two consecutive testing events
ance for two consecutive testing events
or two out of three consecutive testing
events is unsuccessful performance.
§ 493.833 Condition: Diagnostic immu-
nology. § 493.837 Standard; General immu-
nology.
The specialty of diagnostic immu-
nology includes for purposes of pro- (a) Failure to attain a score of at
ficiency testing the subspecialties of least 80 percent of acceptable responses
syphilis serology and general immu- for each analyte in each testing event
nology. is unsatisfactory analyte performance
for the testing event.
§ 493.835 Standard; Syphilis serology. (b) Failure to attain an overall test-
(a) Failure to attain an overall testing event score of at least 80 percent is
ing event score of at least 80 percent is unsatisfactory performance.
unsatisfactory performance. (c) Failure to participate in a testing
(b) Failure to participate in a testing event is unsatisfactory performance
event is unsatisfactory performance and results in a score of 0 for the test-
and results in a score of 0 for the testing event. Consideration may be given
ing event. Consideration may be given to those laboratories failing to partici-
to those laboratories failing to participate in a testing event only if—
pate in a testing event only if— (1) Patient testing was suspended
(1) Patient testing was suspended during the time frame allotted for test-
during the time frame allotted for testing and reporting proficiency testing
ing and reporting proficiency testing results;
results; (2) The laboratory notifies the in-
(2) The laboratory notifies the in- specting agency and the proficiency
specting agency and the proficiency testing program within the time frame
ing and the circumstances associated
ing and the circumstances associated
with failure to perform tests on pro-
with failure to perform tests on pro-
ficiency testing samples; and
ficiency testing samples; and
(3) The laboratory participated in the (3) The laboratory participated in the
previous two proficiency testing previous two proficiency testing
events. events.
(c) Failure to return proficiency test- (d) Failure to return proficiency test-
ing results to the proficiency testing ing results to the proficiency testing
program within the time frame speci- program within the time frame speci-
fied by the program is unsatisfactory fied by the program is unsatisfactory
performance and results in a score of 0 performance and results in a score of 0
for the testing event. for the testing event.

(d)(1) For any unsatisfactory testing (e)(1) For any unsatisfactory analyte
event for reasons other than a failure or test performance or testing event
652
for reasons other than a failure to par- (3) The laboratory participated in the
ticipate, the laboratory must under- previous two proficiency testing
take appropriate training and employ events.
the technical assistance necessary to (d) Failure to return proficiency test-
correct problems associated with a pro- ing results to the proficiency testing
ficiency testing failure. program within the time frame speci-
(2) For any unacceptable analyte or fied by the program is unsatisfactory
testing event score, remedial action performance and results in a score of 0
must be taken and documented, and for the testing event.
the documentation must be maintained (e)(1) For any unsatisfactory analyte
by the laboratory for two years from or test performance or testing event
the date of participation in the pro- for reasons other than a failure to par-
ficiency testing event. ticipate, the laboratory must under-
(f) Failure to achieve satisfactory take appropriate training and employ
performance for the same analyte or the technical assistance necessary to
test in two consecutive testing events correct problems associated with a pro-
or two out of three consecutive testing ficiency testing failure.
events is unsuccessful performance. (2) For any unacceptable analyte or
(g) Failure to achieve an overall test- testing event score, remedial action
ing event score of satisfactory perform- must be taken and documented, and
ance for two consecutive testing events the documentation must be maintained
or two out of three consecutive testing by the laboratory for two years from
events is unsuccessful performance. the date of participation in the pro-
ficiency testing event.
§ 493.839 Condition: Chemistry. (f) Failure to achieve satisfactory
The specialty of chemistry includes performance for the same analyte or
for the purposes of proficiency testing test in two consecutive testing events
the subspecialties of routine chem- or two out of three consecutive testing
istry, endocrinology, and toxicology. events is unsuccessful performance.
(g) Failure to achieve an overall test-
§ 493.841 Standard; Routine chemistry. ing event score of satisfactory perform-
(a) Failure to attain a score of at ance for two consecutive testing events
least 80 percent of acceptable responses or two out of three consecutive testing
for each analyte in each testing event events is unsuccessful performance.
is unsatisfactory analyte performance
§ 493.843 Standard; Endocrinology.
for the testing event.
(b) Failure to attain an overall test- (a) Failure to attain a score of at
ing event score of at least 80 percent is least 80 percent of acceptable responses
unsatisfactory performance. for each analyte in each testing event
(c) Failure to participate in a testing is unsatisfactory analyte performance
event is unsatisfactory performance for the testing event.
and results in a score of 0 for the test- (b) Failure to attain an overall test-
ing event. Consideration may be given ing event score of at least 80 percent is
to those laboratories failing to partici- unsatisfactory performance.
pate in a testing event only if— (c) Failure to participate in a testing
(1) Patient testing was suspended event is unsatisfactory performance
during the time frame allotted for test- and results in a score of 0 for the test-
ing and reporting proficiency testing ing event. Consideration may be given
results; to those laboratories failing to partici-
(2) The laboratory notifies the in- pate in a testing event only if—
specting agency and the proficiency (1) Patient testing was suspended
testing program within the time frame during the time frame allotted for test-
for submitting proficiency testing re- ing and reporting proficiency testing
sults of the suspension of patient test- results;
ing and the circumstances associated (2) The laboratory notifies the in-
with failure to perform tests on pro- specting agency and the proficiency
ficiency testing samples; and testing program within the time frame
653
§ 493.845 42 CFR Ch. IV (10–1–17 Edition)
for submitting proficiency testing re- (2) The laboratory notifies the in-
sults of the suspension of patient test- specting agency and the proficiency
ing and the circumstances associated testing program within the time frame
with failure to perform tests on pro- for submitting proficiency testing re-
ficiency testing samples; and sults of the suspension of patient test-
(3) The laboratory participated in the ing and the circumstances associated
previous two proficiency testing with failure to perform tests on pro-
events. ficiency testing samples; and
(d) Failure to return proficiency test- (3) The laboratory participated in the
ing results to the proficiency testing previous two proficiency testing
program within the time frame speci- events.
fied by the program is unsatisfactory (d) Failure to return proficiency test-
performance and results in a score of 0 ing results to the proficiency testing
for the testing event. program within the time frame speci-
(e)(1) For any unsatisfactory analyte fied by the program is unsatisfactory
or test performance or testing event performance and results in a score of 0
for reasons other than a failure to par- for the testing event.
ticipate, the laboratory must under- (e)(1) For any unsatisfactory analyte
take appropriate training and employ or test performance or testing event
the technical assistance necessary to for reasons other than a failure to par-
correct problems associated with a pro- ticipate, the laboratory must under-
ficiency testing failure. take appropriate training and employ
(2) For any unacceptable analyte or the technical assistance necessary to
testing event score, remedial action correct problems associated with a pro-
must be taken and documented, and ficiency testing failure.
the documentation must be maintained (2) For any unacceptable analyte or
by the laboratory for two years from testing event score, remedial action
the date of participation in the pro- must be taken and documented, and
ficiency testing event. the documentation must be maintained
(f) Failure to achieve satisfactory by the laboratory for two years from
performance for the same analyte or the date of participation in the pro-
test in two consecutive testing events ficiency testing event.
or two out of three consecutive testing (f) Failure to achieve satisfactory
events is unsuccessful performance. performance for the same analyte or
(g) Failure to achieve an overall test- test in two consecutive testing events
ing event score of satisfactory perform- or two out of three consecutive testing
ance for two consecutive testing events events is unsuccessful performance.
(g) Failure to achieve an overall test-
§ 493.845 Standard; Toxicology. ance for two consecutive testing events
(a) Failure to attain a score of at events is unsuccessful performance.
least 80 percent of acceptable responses
for each analyte in each testing event § 493.849 Condition: Hematology.
is unsatisfactory analyte performance
for the testing event. The specialty of hematology, for the
(b) Failure to attain an overall test- purpose of proficiency testing, is not
ing event score of at least 80 percent is subdivided into subspecialties of test-
unsatisfactory performance. ing.
(c) Failure to participate in a testing
§ 493.851 Standard; Hematology.
event is unsatisfactory performance
and results in a score of 0 for the test- (a) Failure to attain a score of at
ing event. Consideration may be given least 80 percent of acceptable responses
to those laboratories failing to partici- for each analyte in each testing event
pate in a testing event only if— is unsatisfactory analyte performance
(1) Patient testing was suspended for the testing event.
during the time frame allotted for test- (b) Failure to attain an overall test-
ing and reporting proficiency testing ing event score of at least 80 percent is
results; unsatisfactory performance.
654
(c) Failure to participate in a testing § 493.855 Standard; Cytology:

event is unsatisfactory performance gynecologic examinations.
and results in a score of 0 for the test- To participate successfully in a cy-
ing event. Consideration may be given tology proficiency testing program for
to those laboratories failing to partici- gynecologic examinations (Pap
pate in a testing event only if— smears), the laboratory must meet the
(1) Patient testing was suspended requirements of paragraphs (a) through
during the time frame allotted for test- (c) of this section.
ing and reporting proficiency testing (a) The laboratory must ensure that
results; each individual engaged in the exam-
(2) The laboratory notifies the in- ination of gynecologic preparations is
specting agency and the proficiency enrolled in a proficiency testing pro-
testing program within the time frame gram approved by CMS by January 1,
for submitting proficiency testing re- 1995, if available in the State in which
sults of the suspension of patient test- he or she is employed. The laboratory
ing and the circumstances associated must ensure that each individual is
with failure to perform tests on pro- tested at least once per year and ob-
ficiency testing samples; and tains a passing score. To ensure this
(3) The laboratory participated in the annual testing of individuals, an an-
previous two proficiency testing nounced or unannounced testing event
events. will be conducted on-site in each lab-
(d) Failure to return proficiency test- oratory at least once each year. Lab-
ing results to the proficiency testing oratories will be notified of the time of
program within the time frame speci- each announced on-site testing event
fied by the program is unsatisfactory at least 30 days prior to each event. Ad-
performance and results in a score of 0 ditional testing events will be con-
for the testing event. ducted as necessary in each State or
(e)(1) For any unsatisfactory analyte region for the purpose of testing indi-
or test performance or testing event viduals who miss the on-site testing
for reasons other than a failure to par- event and for retesting individuals as
ticipate, the laboratory must under- described in paragraph (b) of this sec-
take appropriate training and employ tion.
the technical assistance necessary to (b) The laboratory must ensure that
correct problems associated with a pro- each individual participates in an an-
ficiency testing failure. nual testing event that involves the ex-
amination of a 10-slide test set as de-
(2) For any unacceptable analyte or
scribed in § 493.945. Individuals who fail
testing event score, remedial action
this testing event are retested with an-
must be taken and documented, and
other 10-slide test set as described in
the documentation must be maintained
paragraphs (b)(1) and (b)(2) of this sec-
by the laboratory for two years from
tion. Individuals who fail this second
the date of participation in the pro-
test are subsequently retested with a
ficiency testing event.
20-slide test set as described in para-
(f) Failure to achieve satisfactory graphs (b)(2) and (b)(3) of this section.
performance for the same analyte in Individuals are given not more than 2
two consecutive events or two out of hours to complete a 10-slide test and
three consecutive testing events is un- not more than 4 hours to complete a 20-
successful performance. slide test. Unexcused failure to appear
(g) Failure to achieve an overall test- by an individual for a retest will result
ing event score of satisfactory perform- in test failure with resulting remedi-
ance for two consecutive testing events ation and limitations on slide examina-
or two out of three consecutive testing tions as specified in (b)(1), (b)(2), and
events is unsuccessful performance. (b)(3) of this section.
(1) An individual is determined to
§ 493.853 Condition: Pathology. have failed the annual testing event if
The specialty of pathology includes, he or she scores less than 90 percent on
for purposes of proficiency testing, the a 10-slide test set. For an individual
subspecialty of cytology limited to who fails an annual proficiency testing
gynecologic examinations. event, the laboratory must schedule a
655
§ 493.857 42 CFR Ch. IV (10–1–17 Edition)
retesting event which must take place body detection; compatibility testing;
not more than 45 days after receipt of and antibody identification.
the notification of failure.
(2) An individual is determined to § 493.859 Standard; ABO group and D
have failed the second testing event if (Rho) typing.
he or she scores less than 90 percent on (a) Failure to attain a score of at
a 10-slide test set. For an individual least 100 percent of acceptable re-
who fails a second testing event, the sponses for each analyte or test in each
laboratory must provide him or her testing event is unsatisfactory analyte
with documented, remedial training performance for the testing event.
and education in the area of failure, (b) Failure to attain an overall test-
and must assure that all gynecologic ing event score of at least 100 percent
slides evaluated subsequent to the no- is unsatisfactory performance.
tice of failure are reexamined until the (c) Failure to participate in a testing
individual is again retested with a 20- event is unsatisfactory performance
slide test set and scores at least 90 per- and results in a score of 0 for the test-
cent. Reexamination of slides must be ing event. Consideration may be given
documented. to those laboratories failing to partici-
(3) An individual is determined to pate in a testing event only if—
have failed the third testing event if he (1) Patient testing was suspended
or she scores less than 90 percent on a during the time frame allotted for test-
20-slide test set. An individual who ing and reporting proficiency testing
fails the third testing event must cease results;
examining gynecologic slide prepara- (2) The laboratory notifies the in-
tions immediately upon notification of specting agency and the proficiency
test failure and may not resume exam- testing program within the time frame
ining gynecologic slides until the lab- for submitting proficiency testing re-
oratory assures that the individual ob- sults of the suspension of patient test-
tains at least 35 hours of documented, ing and the circumstances associated
formally structured, continuing edu- with failure to perform tests on pro-
cation in diagnostic cytopathology ficiency testing samples; and
that focuses on the examination of (3) The laboratory participated in the
gynecologic preparations, and until he previous two proficiency testing
or she is retested with a 20-slide test events.
set and scores at least 90 percent. (d) Failure to return proficiency test-
(c) If a laboratory fails to ensure that ing results to the proficiency testing
individuals are tested or those who fail program within the time frame speci-
a testing event are retested, or fails to fied by the program is unsatisfactory
take required remedial actions as de- performance and results in a score of 0
scribed in paragraphs (b)(1), (b)(2) or for the testing event.
(b)(3) of this section, CMS will initiate (e)(1) For any unsatisfactory testing
intermediate sanctions or limit the event for reasons other than a failure
laboratory’s certificate to exclude to participate, the laboratory must un-
gynecologic cytology testing under dertake appropriate training and em-
CLIA, and, if applicable, suspend the ploy the technical assistance necessary
laboratory’s Medicare and Medicaid to correct problems associated with a
payments for gynecologic cytology proficiency testing failure.
testing in accordance with subpart R of (2) For any unacceptable analyte or
this part. unsatisfactory testing event score, re-
[57 FR 7146, Feb. 28, 1992, as amended at 58 medial action must be taken and docu-
FR 5228, Jan. 19, 1993; 59 FR 62609, Dec. 6, mented, and the documentation must
1994] be maintained by the laboratory for
two years from the date of participa-
§ 493.857 Condition: tion in the proficiency testing event.
Immunohematology. (f) Failure to achieve satisfactory
The specialty of immunohematology performance for the same analyte in
includes four subspecialties for the pur- two consecutive testing events or two
poses of proficiency testing: ABO group out of three consecutive testing events
and D (Rho) typing; unexpected anti- is unsuccessful performance.
656
(g) Failure to achieve an overall test- § 493.863 Standard; Compatibility test-

ing event score of satisfactory for two ing.
consecutive testing events or two out (a) Failure to attain an overall test-
of three consecutive testing events is ing event score of at least 100 percent
unsuccessful performance. is unsatisfactory performance.
(b) Failure to participate in a testing
§ 493.861 Standard; Unexpected anti- event is unsatisfactory performance
body detection. and results in a score of 0 for the test-
(a) Failure to attain an overall testing event. Consideration may be given
ing event score of at least 80 percent is to those laboratories failing to partici-
unsatisfactory performance. pate in a testing event only if—
(b) Failure to participate in a testing (1) Patient testing was suspended
event is unsatisfactory performance during the time frame allotted for test-
and results in a score of 0 for the testing and reporting proficiency testing
ing event. Consideration may be given results;
(2) The laboratory notifies the in-
specting agency and the proficiency
(1) Patient testing was suspended for submitting proficiency testing re-
during the time frame allotted for test- sults of the suspension of patient test-
ing and reporting proficiency testing ing and the circumstances associated
results; with failure to perform tests on pro-
(2) The laboratory notifies the in- ficiency testing samples; and
specting agency and the proficiency (3) The laboratory participated in the
testing program within the time frame previous two proficiency testing
for submitting proficiency testing re- events.
sults of the suspension of patient test- (c) Failure to return proficiency test-
ing and the circumstances associated ing results to the proficiency testing
with failure to perform tests on pro- program within the time frame speci-
ficiency testing samples; and fied by the program is unsatisfactory
(3) The laboratory participated in the performance and results in a score of 0
previous two proficiency testing for the testing event.
events. (d)(1) For any unsatisfactory testing
(c) Failure to return proficiency test- event for reasons other than a failure
ing results to the proficiency testing to participate, the laboratory must un-
program within the time frame speci- dertake appropriate training and em-
fied by the program is unsatisfactory ploy the technical assistance necessary
performance and results in a score of 0 to correct problems associated with a
for the testing event. proficiency testing failure.
(d)(1) For any unsatisfactory testing (2) For any unsatisfactory testing
event for reasons other than a failure event score, remedial action must be
to participate, the laboratory must un- taken and documented, and the docu-
dertake appropriate training and em- mentation must be maintained by the
laboratory for two years from the date
ploy the technical assistance necessary
of participation in the proficiency test-
to correct problems associated with a
ing event.
proficiency testing failure.
(2) For any unsatisfactory testing ing event score of satisfactory for two
event score, remedial action must be consecutive testing events or two out
taken and documented, and the docu- of three consecutive testing events is
mentation must be maintained by the unsuccessful performance.
laboratory for two years from the date
of participation in the proficiency test- § 493.865 Standard; Antibody identi-
ing event. fication.
(e) Failure to achieve an overall test- (a) Failure to attain an overall test-
ing event score of satisfactory for two ing event score of at least 80 percent is
consecutive testing events or two out unsatisfactory performance.

of three consecutive testing events is (b) Failure to participate in a testing
unsuccessful performance. event is unsatisfactory performance
657
§ 493.901 42 CFR Ch. IV (10–1–17 Edition)
and results in a score of 0 for the test- gram must be offered by a private non-
ing event. Consideration may be given profit organization or a Federal or
to those laboratories failing to partici- State agency, or entity acting as a des-
pate in a testing event only if— ignated agent for the State. An organi-
(1) Patient testing was suspended zation, Federal, or State program seek-
during the time frame allotted for testing approval or reapproval for its pro-
ing and reporting proficiency testing gram for the next calendar year must
results; submit an application providing the re-
(2) The laboratory notifies the in- quired information by July 1 of the
specting agency and the proficiency current year. The organization, Fed-
testing program within the time frame eral, or State program must provide
for submitting proficiency testing re- technical assistance to laboratories
sults of the suspension of patient test- seeking to qualify under the program,
ing and the circumstances associated and must, for each specialty, sub-
with failure to perform tests on pro- specialty, and analyte or test for which
ficiency testing samples; and it provides testing—
(3) The laboratory participated in the (a) Assure the quality of test sam-
previous two proficiency testing ples, appropriately evaluate and score
events. the testing results, and identify per-
(c) Failure to return proficiency test- formance problems in a timely manner;
ing results to the proficiency testing (b) Demonstrate to HHS that it has—
program within the time frame speci- (1) The technical ability required to—
fied by the program is unsatisfactory (i) Prepare or purchase samples from
performance and results in a score of 0 manufacturers who prepare the sam-
for the testing event. ples in conformance with the appro-
(d)(1) For any unsatisfactory testing priate good manufacturing practices
event for reasons other than a failure required in 21 CFR parts 606, 640, and
to participate, the laboratory must un- 820; and
dertake appropriate training and em- (ii) Distribute the samples, using rig-
ploy the technical assistance necessary orous quality control to assure that
to correct problems associated with a samples mimic actual patient speci-
proficiency testing failure. mens when possible and that samples
(2) For any unsatisfactory testing are homogeneous, except for specific
event score, remedial action must be subspecialties such as cytology, and
taken and documented, and the docu- will be stable within the time frame for
mentation must be maintained by the analysis by proficiency testing partici-
laboratory for two years from the date pants;
of participation in the proficiency test- (2) A scientifically defensible process
ing event. for determining the correct result for
(e) Failure to identify the same anti- each challenge offered by the program;
body in two consecutive or two out of (3) A program of sufficient annual
three consecutive testing events is un- challenge and with the frequency speci-
successful performance. fied in §§ 493.909 through 493.959 to es-
(f) Failure to achieve an overall test- tablish that a laboratory has met min-
ing event score of satisfactory for two imum performance requirements;
consecutive testing events or two out (4) The resources needed to provide
of three consecutive testing events is Statewide or nationwide reports to reg-
unsuccessful performance. ulatory agencies on individual’s per-
formance for gynecologic cytology and
Subpart I—Proficiency Testing on individual laboratory performance
Programs for Nonwaived Testing on testing events, cumulative reports
and scores for each laboratory or indi-
SOURCE: 57 FR 7151, Feb. 28, 1992, unless vidual, and reports of specific labora-
otherwise noted. tory failures using grading criteria ac-
ceptable to HHS. These reports must be
§ 493.901 Approval of proficiency test- provided to HHS on a timely basis
ing programs. when requested;

In order for a proficiency testing pro- (5) Provisions to include on each pro-
gram to receive HHS approval, the proficiency testing program report form
658
used by the laboratory to record test- ploy the individuals, within 15 working
ing event results, an attestation state- days of the testing event;
ment that proficiency testing samples (b) Furnish to HHS cumulative re-
were tested in the same manner as pa- ports on an individual laboratory’s per-
tient specimens with a signature block formance and aggregate data on CLIA-
to be completed by the individual per- certified laboratories for the purpose of
forming the test as well as by the lab- establishing a system to make the pro-
oratory director; ficiency testing program’s results
(6) A mechanism for notifying par- available, on a reasonable basis, upon
ticipants of the PT shipping schedule request of any person, and include such
and for participants to notify the pro- explanatory information as may be ap-
ficiency testing program within three propriate to assist in the interpreta-
days of the expected date of receipt of
tion of the proficiency testing pro-
the shipment that samples have not ar-
gram’s results;
rived or are unacceptable for testing.
The program must have provisions for (c) Provide HHS with additional in-
replacement of samples that are lost in formation and data upon request and
transit or are received in a condition submit such information necessary for
that is unacceptable for testing; and HHS to conduct an annual evaluation
(7) A process to resolve technical, ad- to determine whether the proficiency
ministrative, and scientific problems testing program continues to meet the
about program operations; requirements of §§ 493.901 through
(c) Meet the specific criteria for pro- 493.959;
ficiency testing programs listed by spe- (d) Maintain records of laboratories’
cialty, subspecialty, and analyte or performance for a period of five years
test contained in §§ 493.901 through or such time as may be necessary for
493.959 for initial approval and there- any legal proceedings; and
after provide HHS, on an annual basis, (e) Provide HHS with an annual re-
with the information necessary to as- port and, if needed, an interim report
sure that the proficiency testing pro- which identifies any previously unrec-
gram meets the criteria required for ognized sources of variability in kits,
approval; and instruments, methods, or PT samples,
(d) Comply with all applicable pack- which adversely affect the programs’
aging, shipment, and notification re- ability to evaluate laboratory perform-
quirements of 42 CFR part 72. ance.
[57 FR 7151, Feb. 28, 1992, as amended at 58 [57 FR 7151, Feb. 28, 1992, as amended at 58
FR 5228, Jan. 19, 1993] FR 5228, Jan. 19, 1993]
§ 493.903 Administrative responsibil-
ities. § 493.905 Nonapproved proficiency
testing programs.
The proficiency testing program
must— If a proficiency testing program is
(a)(1) Provide HHS or its designees determined by HHS to fail to meet any
and participating laboratories with an criteria contained in §§ 493.901 through
electronic or a hard copy, or both, of 493.959 for approval of the proficiency
reports of proficiency testing results testing program, CMS will notify the
and all scores for each laboratory’s per- program and the program must notify
formance in a format as required by all laboratories enrolled of the non-
and approved by CMS for each CLIA- approval and the reasons for non-
certified specialty, subspecialty, and approval within 30 days of the notifica-
analyte or test within 60 days after the tion.
date by which the laboratory must re-
port proficiency testing results to the PROFICIENCY TESTING PROGRAMS BY
proficiency testing program. SPECIALTY AND SUBSPECIALTY
(2) Provide HHS with reports of PT
§ 493.909 Microbiology.
results and scores of individual per-
formance in cytology and provide cop- The subspecialties under the spe-
ies of reports to participating individ- cialty of microbiology for which a pro-
uals, and to all laboratories that em- gram may offer proficiency testing are
659
§ 493.911 42 CFR Ch. IV (10–1–17 Edition)
bacteriology, mycobacteriology, my- cilli, gram-positive cocci, gram-nega-

cology, parasitology and virology. Spe- tive cocci, and miscellaneous gram-
cific criteria for these subspecialties negative bacteria, as appropriate. The
are found at §§ 493.911 through 493.919. specific organisms included in the sam-
ples may vary from year to year. The
§ 493.911 Bacteriology. annual program must include samples
(a) Types of services offered by labora- for bacterial antigen detection, bac-
tories. In bacteriology, for proficiency terial isolation and identification,
testing purposes, there are five types of Gram stain, and antimicrobial suscep-
laboratories: tibility testing.
(1) Those that interpret Gram stains (1) An approved program must fur-
or perform primary inoculation, or nish HHS with a description of samples
both; and refer cultures to another lab- that it plans to include in its annual
oratory appropriately certified for the program no later than six months be-
subspecialty of bacteriology for identi- fore each calendar year. At least 50 per-
fication; cent of the samples must be mixtures
(2) Those that use direct antigen of the principal organism and appro-
techniques to detect an organism and priate normal flora. The program must
may also interpret Gram stains or per- include other important emerging
form primary inoculation, or perform pathogens (as determined by HHS) and
any combination of these; either organisms commonly occurring
(3) Those that, in addition to inter- in patient specimens or opportunistic
preting Gram stains, performing pri- pathogens. The program must include
mary inoculations, and using direct the following two types of samples;
antigen tests, also isolate and identify each type of sample must meet the 50
aerobic bacteria from throat, urine, percent mixed culture criterion:
cervical, or urethral discharge speci- (i) Samples that require laboratories
mens to the genus level and may also to report only organisms that the test-
perform antimicrobial susceptibility ing laboratory considers to be a prin-
tests on selected isolated microorga- cipal pathogen that is clearly respon-
nisms; sible for a described illness (excluding
(4) Those that perform the services in immuno-compromised patients). The
paragraph (a)(3) of this section and also program determines the reportable iso-
isolate and identify aerobic bacteria lates, including antimicrobial suscepti-
from any source to the species level bility for any designated isolate; and
and may also perform antimicrobial (ii) Samples that require laboratories
susceptibility tests; and to report all organisms present. Sam-
(5) Those that perform the services in ples must contain multiple organisms
paragraph (a)(4) of this section and also frequently found in specimens such as
isolate and identify anaerobic bacteria urine, blood, abscesses, and aspirates
from any source. where multiple isolates are clearly sig-
(b) Program content and frequency of nificant or where specimens are de-
challenge. To be approved for pro- rived from immuno-compromised pa-
ficiency testing for bacteriology, the tients. The program determines the re-
annual program must provide a min- portable isolates.
imum of five samples per testing event. (2) An approved program may vary
There must be at least three testing over time. For example, the types of
events at approximately equal inter- organisms that might be included in an
vals per year. The samples may be pro- approved program over time are—
vided to the laboratory through mailed Anaerobes:
shipments or, at HHS’ option, may be Bacteroides fragilis group
provided to HHS or its designee for on- Clostridium perfringens
site testing. For the types of labora- Peptostreptococcus anaerobius
tories specified in paragraph (a) of this Enterobacteriaceae
section, an annual program must in- Citrobacter freundii
Enterobacter aerogenes
clude samples that contain organisms
Escherichia coli
that are representative of the six major Klebsiella pneumoniae
groups of bacteria: anaerobes, Proteus mirabilis
Enterobacteriaceae, gram-positive ba- Salmonella typhimurium
660
Serratia marcescens fied in paragraph (a)(3) of this section
Shigella sonnei will be evaluated on the basis of the av-
Yersinia enterocolitica erage of its scores for paragraphs (c)(3)
Gram-positive bacilli:
Listeria monocytogenes
through (c)(6) as determined in para-
Corynebacterium species CDC Group JK graph (c)(7) of this section.
Gram-positive cocci: (3) Since laboratories may incor-
Staphylococcus aureus rectly report the presence of organisms
Streptococcus Group A in addition to the correctly identified
Streptococcus Group B principal organism(s), the grading sys-
Streptococcus Group D (S. bovis and tem must provide a means of deducting
enterococcus)
credit for additional erroneous orga-
Streptococcus pneumoniae
Gram-negative cocci: nisms that are reported. Therefore, the
Branhamella catarrhalis total number of correct responses for
Neisseria gonorrhoeae organism isolation and identification
Neisseria meningitidis submitted by the laboratory divided by
Miscellaneous Gram-negative bacteria: the number of organisms present plus
Campylobacter jejuni the number of incorrect organisms re-
Haemophilis influenza, Type B ported by the laboratory must be mul-
Pseudomonas aeruginosa
tiplied by 100 to establish a score for
(3) For antimicrobial susceptibility each sample in each testing event. For
testing, the program must provide at example, if a sample contained one
least one sample per testing event that principal organism and the laboratory
includes gram-positive or gram-nega- reported it correctly but reported the
tive strains that have a predetermined presence of an additional organism,
pattern of sensitivity or resistance to which was not considered reportable,
the common antimicrobial agents. the sample grade would be 1/(1 + 1) × 100
(c) Evaluation of a laboratory’s per- = 50 percent.
formance. HHS approves only those pro- (4) For antimicrobial susceptibility
grams that assess the accuracy of a testing, a laboratory must indicate
laboratory’s responses in accordance which drugs are routinely included in
with paragraphs (c) (1) through (7) of its test panel when testing patient
this section. samples. A laboratory’s performance
(1) The program determines staining will be evaluated for only those anti-
characteristics to be interpreted by biotics for which service is offered. A
Gram stain. The program determines correct response for each antibiotic
the reportable bacteria to be detected will be determined as described in
by direct antigen techniques or isola- § 493.911(c) (1) using criteria such as the
tion. To determine the accuracy of a guidelines established by the National
laboratory’s response for Gram stain Committee for Clinical Laboratory
interpretation, direct antigen detec- Standards. Grading is based on the
tion, identification, or antimicrobial number of correct susceptibility re-
susceptibility testing, the program sponses reported by the laboratory di-
must compare the laboratory’s re- vided by the actual number of correct
sponse for each sample with the re- susceptibility responses determined by
sponse which reflects agreement of ei- the program, multiplied by 100. For ex-
ther 80 percent of ten or more referee ample, if a laboratory offers suscepti-
laboratories or 80 percent or more of bility testing for Enterobacteriaceae
all participating laboratories. using amikacin, cephalothin, and
(2) To evaluate a laboratory’s re- tobramycin, and the organism in the
sponse for a particular sample, the pro- proficiency testing sample is an
gram must determine a laboratory’s Enterobacteriaceae, and the laboratory
type of service in accordance with reports correct responses for two of
paragraph (a) of this section. A labora- three antimicrobial agents, the labora-
tory must isolate and identify the or- tory’s grade would be 2/3 × 100 = 67 per-
ganisms to the same extent it performs cent.
these procedures on patient specimens. (5) The performance criterion for
A laboratory’s performance will be qualitative antigen tests is the pres-

evaluated on the basis of its final an- ence or absence of the bacterial anti-
swer, for example, a laboratory speci- gen. The score for antigen tests is the
661
§ 493.913 42 CFR Ch. IV (10–1–17 Edition)
number of correct responses divided by (b) Program content and frequency of

the number of samples to be tested for challenge. To be approved for pro-
the antigen, multiplied by 100. ficiency testing for mycobacteriology,
(6) The performance criteria for the annual program must provide a
Gram stain is staining reaction, i.e., minimum of five samples per testing
gram positive or gram negative. The event. There must be at least two test-
score for Gram stain is the number of ing events per year. The samples may
correct responses divided by the num- be provided through mailed shipments
ber of challenges to be tested, multi- or, at HHS’ option, provided to HHS or
plied by 100. its designee for on-site testing events.
(7) The score for a testing event in For types of laboratories specified in
bacteriology is the average of the paragraphs (a)(1) and (a) (3) through (5)
scores determined under paragraphs of this section, an annual program
(c)(3) through (c)(6) of this section must include samples that contain spe-
kbased on the type of service offered by cies that are representative of the 5
the laboratory. major groups (complexes) of
mycobacteria encountered in human
[57 FR 7151, Feb. 28, 1992, as amended at 58 specimens. The specific mycobacteria
FR 5228, Jan. 19, 1993; 68 FR 3702, Jan. 24,
2003]
included in the samples may vary from
year to year.
§ 493.913 Mycobacteriology. (1) An approved program must fur-
nish HHS and its agents with a descrip-
(a) Types of services offered by labora- tion of samples that it plans to include
tories. In mycobacteriology, there are in its annual program no later than six
five types of laboratories for pro- months before each calendar year. At
ficiency testing purposes: least 50 percent of the samples must be
(1) Those that interpret acid-fast mixtures of the principal mycobacteria
stains and refer specimen to another and appropriate normal flora. The pro-
laboratory appropriately certified in gram must include mycobacteria com-
the subspecialty of mycobacteriology; monly occurring in patient specimens
(2) Those that interpret acid-fast and other important emerging
stains, perform primary inoculation, mycobacteria (as determined by HHS).
and refer cultures to another labora- The program determines the reportable
tory appropriately certified in the sub- isolates and correct responses for
specialty of mycobacteriology for iden- antimycobacterial susceptibility for
tification; any designated isolate.
(3) Those that interpret acid-fast (2) An approved program may vary
stains, isolate and perform identifica- over time. For example, the types of
tion and/or antimycobacterial suscepti- mycobacteria that might be included
bility of Mycobacterium tuberculosis, but in an approved program over time are—
refer other mycobacteria species to an-
other laboratory appropriately cer- TB
Mycobacterium tuberculosis
tified in the subspecialty of
Mycobacterium bovis
mycobacteriology for identification Group I
and/or susceptibility tests; Mycobacterium kansasii
(4) Those that interpret acid-fast Group II
stains, isolate and identify all Mycobacterium szulgai
mycobacteria to the extent required Group III
for correct clinical diagnosis, but refer Mycobacterium avium-intracellulare
antimycobacterial susceptibility tests Mycobacterium terrae
to another laboratory appropriately Group IV
Mycobacterium fortuitum
certified in the subspecialty of
mycobacteriology; and (3) For antimycobacterial suscepti-
(5) Those that interpret acid-fast bility testing, the program must pro-
stains, isolate and identify all vide at least one sample per testing
mycobacteria to the extent required event that includes mycobacterium tu-
for correct clinical diagnosis, and per- berculosis that has a predetermined
form antimycobacterial susceptibility pattern of sensitivity or resistance to
tests on the organisms isolated. the common antimycobacterial agents.
662
(4) For laboratories specified in para- (4) For antimycobacterial suscepti-

graphs (a)(1) and (a)(2), the program bility testing, a laboratory must indi-
must provide at least five samples per cate which drugs are routinely in-
testing event that includes challenges cluded in its test panel when testing
that are acid-fast and challenges which patient samples. A laboratory’s per-
do not contain acid-fast organisms. formance will be evaluated for only
(c) Evaluation of a laboratory’s per- those antibiotics for which suscepti-
formance. HHS approves only those pro- bility testing is routinely performed on
grams that assess the accuracy of a patient specimens. A correct response
laboratory’s response in accordance for each antibiotic will be determined
with paragraphs (c)(1) through (6) of as described in § 493.913(c)(1). Grading is
this section. based on the number of correct suscep-
(1) The program determines the re- tibility responses reported by the lab-
portable mycobacteria to be detected oratory divided by the actual number
by acid-fast stain, for isolation and of correct susceptibility responses as
identification, and for determined by the program, multiplied
antimycobacterial susceptibility. To by 100. For example, if a laboratory of-
determine the accuracy of a labora- fers susceptibility testing using three
tory’s response, the program must antimycobacterial agents and the lab-
compare the laboratory’s response for oratory reports correct response for
each sample with the response that re- two of the three antimycobacterial
flects agreement of either 80 percent of agents, the laboratory’s grade would be
ten or more referee laboratories or 80 2⁄3 × 100 = 67 percent.
percent or more of all participating (5) The performance criterion for

laboratories. qualitative tests is the presence or ab-
(2) To evaluate a laboratory’s re- sence of acid-fast organisms. The score
sponse for a particular sample, the pro- for acid-fast organism detection is the
gram must determine a laboratory’s number of correct responses divided by
type of service in accordance with the number of samples to be tested,
paragraph (a) of this section. A labora- multiplied by 100.
tory must interpret acid-fast stains (6) The score for a testing event in
and isolate and identify the organisms mycobacteriology is the average of the
to the same extent it performs these scores determined under paragraphs
procedures on patient specimens. A (c)(3) through (c)(5) of this section
laboratory’s performance will be evalu- based on the type of service offered by
ated on the basis of the average of its the laboratory.
scores as determined in paragraph
(c)(6) of this section. [57 FR 7151, Feb. 28, 1992, as amended at 58
(3) Since laboratories may incor- FR 5228, Jan. 19, 1993; 68 FR 3702, Jan. 24,
2003]
rectly report the presence of organisms
in addition to the correctly identified § 493.915 Mycology.
principal organism(s), the grading sys-
tem must provide a means of deducting (a) Types of services offered by labora-
credit for additional erroneous orga- tories. In mycology, there are four
nisms reported. Therefore, the total types of laboratories for proficiency
number of correct responses submitted testing purposes that may perform dif-
by the laboratory divided by the num- ferent levels of service for yeasts,
ber of organisms present plus the num- dimorphic fungi, dermatophytes, and
ber of incorrect organisms reported by aerobic actinomycetes:
the laboratory must be multiplied by (1) Those that isolate and identify
100 to establish a score for each sample only yeasts and/or dermatophytes to
in each testing event. For example, if a the genus level;
sample contained one principal orga- (2) Those that isolate and identify
nism and the laboratory reported it yeasts and/or dermatophytes to the
correctly but reported the presence of species level;
an additional organism, which was not (3) Those that isolate and perform
present, the sample grade would be identification of all organisms to the
1 / (1 + 1) × 100 = 50 percent genus level; and
663
§ 493.917 42 CFR Ch. IV (10–1–17 Edition)
(4) Those that isolate and perform (1) The program determines the re-
identification of all organisms to the portable organisms. To determine the
species level. accuracy of a laboratory’s response,
(b) Program content and frequency of the program must compare the labora-
challenge. To be approved for pro- tory’s response for each sample with
ficiency testing for mycology, the an- the response that reflects agreement of
nual program must provide a minimum either 80 percent of ten or more referee
of five samples per testing event. There laboratories or 80 percent or more of
must be at least three testing events at all participating laboratories.
approximately equal intervals per year. (2) To evaluate a laboratory’s re-
The samples may be provided through sponse for a particular sample, the pro-
mailed shipments or, at HHS’ option, gram must determine a laboratory’s
may be provided to HHS or its designee type of service in accordance with
for on-site testing. An annual program paragraph (a) of this section. A labora-
must include samples that contain or- tory must isolate and identify the or-
ganisms that are representative of five ganisms to the same extent it performs
major groups of fungi: Yeast or yeast- these procedures on patient specimens.
like fungi; dimorphic fungi; (3) Since laboratories may incor-
dematiaceous fungi; dermatophytes; rectly report the presence of organisms
and saprophytes, including opportun- in addition to the correctly identified
istic fungi. The specific fungi included principal organism(s), the grading sys-
in the samples may vary from year to tem must deduct credit for additional
year. erroneous organisms reported. There-
(1) An approved program must, before fore, the total number of correct re-
each calendar year, furnish HHS with a sponses submitted by the laboratory
description of samples that it plans to divided by the number of organisms
include in its annual program no later present plus the number of incorrect
than six months before each calendar organisms reported by the laboratory
year. At least 50 percent of the samples must be multiplied by 100 to establish
must be mixtures of the principal orga- a score for each sample in each ship-
nism and appropriate normal back- ment or testing event. For example, if
ground flora. Other important emerg- a sample contained one principal orga-
ing pathogens (as determined by HHS) nism and the laboratory reported it
and organisms commonly occurring in correctly but reported the presence of
patient specimens must be included pe- an additional organism, which was not
riodically in the program. present, the sample grade would be 1/(1
(2) An approved program may vary + 1)x100 = 50 percent.
over time. As an example, the types of (4) The score for the antigen tests is
organisms that might be included in an the number of correct responses di-
approved program over time are— vided by the number of samples to be
tested for the antigen, multiplied by
Candida albicans
Candida (other species)
100.
Cryptococcus neoformans (5) The score for a testing event is
Sporothrix schenckii the average of the sample scores as de-
Exophiala jeanselmei termined under paragraph (c)(3) or
Fonsecaea pedrosoi (c)(4), or both, of this section.
Microsporum sp.
Acremonium sp. [57 FR 7151, Feb. 28, 1992, as amended at 58
Trichophvton sp. FR 5228, Jan. 19, 1993; 68 FR 3702, Jan. 24,
Aspergillus fumigatus 2003]
Nocardia sp.
Blastomyces dermatitidis 1 § 493.917 Parasitology.
Zygomycetes sp. (a) Types of services offered by labora-
1 NOTE: Provided as a nonviable sample.
tories. In parasitology there are two
(c) Evaluation of a laboratory’s per- types of laboratories for proficiency
formance. HHS approves only those pro- testing purposes—
grams that assess the accuracy of a (1) Those that determine the presence
laboratory’s response, in accordance or absence of parasites by direct obser-

with paragraphs (c)(1) through (5) of vation (wet mount) and/or pinworm
this section. preparations and, if necessary, refer
664
specimens to another laboratory appro- (3) For laboratories specified in para-

priately certified in the subspecialty of graph (a)(1) of this section, the pro-
parasitology for identification; gram must provide at least five sam-
(2) Those that identify parasites ples per testing event that include
using concentration preparations and/ challenges which contain parasites and
or permanent stains. challenges that are devoid of parasites.
(b) Program content and frequency of (c) Evaluation of a laboratory’s per-
challenge. To be approved for pro- formance. HHS approves only those pro-
ficiency testing in parasitology, a programs that assess the accuracy of a
gram must provide a minimum of five laboratory’s responses in accordance
samples per testing event. There must with paragraphs (c)(1) through (6) of
be at least three testing events at ap- this section.
proximately equal intervals per year. (1) The program must determine the
The samples may be provided through reportable parasites. It may elect to es-
mailed shipments or, at HHS’s option, tablish a minimum number of parasites
may be provided to HHS or its designee to be identified in samples before they
for on-site testing. An annual program are reported. Parasites found in rare
must include samples that contain numbers by referee laboratories are not
parasites that are commonly encoun- considered in scoring a laboratory’s
tered in the United States as well as performance; such findings are neutral.
those recently introduced into the To determine the accuracy of a labora-
United States. Other important emerg- tory’s response, the program must
ing pathogens (as determined by HHS) compare the laboratory’s response with
and parasites commonly occurring in the response that reflects agreement of
patient specimens must be included pe- either 80 percent of ten or more referee
riodically in the program. laboratories or 80 percent or more of
(1) An approved program must, before all participating laboratories.
each calendar year furnish HHS with a (2) To evaluate a laboratory’s re-
description of samples that it plans to sponse for a particular sample, the pro-
include in its annual program no later gram must determine a laboratory’s
than six months before each calendar type of service in accordance with
year. Samples must include both paragraph (a) of this section. A labora-
formalinized specimens and PVA (poly- tory must determine the presence or
vinyl alcohol) fixed specimens as well absence of a parasite(s) or concentrate
as blood smears, as appropriate for a and identify the parasites to the same
particular parasite and stage of the extent it performs these procedures on
parasite. The majority of samples must patient specimens.
contain protozoa or helminths or a (3) Since laboratories may incor-
combination of parasites. Some sam- rectly report the presence of parasites
ples must be devoid of parasites. in addition to the correctly identified
principal parasite(s), the grading sys-
(2) An approved program may vary
tem must deduct credit for these addi-
over time. As an example, the types of
tional erroneous parasites reported and
parasites that might be included in an
not found in rare numbers by the pro-
approved program over time are—
gram’s referencing process. Therefore,
Enterobius vermicularis the total number of correct responses
Entamoeba histolytica submitted by the laboratory divided by
Entamoeba coli the number of parasites present plus
Giardia lamblia the number of incorrect parasites re-
Endolimax nana ported by the laboratory must be mul-
Dientamoeba fragilis tiplied by 100 to establish a score for
Iodamoeba butschli each sample in each testing event. For
Chilomastix mesnili
example, if a sample contained one
Hookworm
principal parasite and the laboratory
Ascaris lumbricoides
Strongyloides stercoralis
reported it correctly but reported the
Trichuris trichiura presence of an additional parasite,
Diphyllobothrium latum which was not present, the sample

Cryptosporidium sp. grade would be
Plasmodium falciparum 1/(1 + 1) × 100 = 50 percent.
665
§ 493.919 42 CFR Ch. IV (10–1–17 Edition)
(4) The criterion for acceptable per- proved program over time are the more
formance for qualitative parasitology commonly identified viruses such as
examinations is presence or absence of Herpes simplex, respiratory syncytial
a parasite(s). virus, adenoviruses, enteroviruses, and
(5) The score for parasitology is the cytomegaloviruses.
number of correct responses divided by (c) Evaluation of laboratory’s perform-
the number of samples to be tested, ance. HHS approves only those pro-
multiplied by 100. grams that assess the accuracy of a
(6) The score for a testing event is laboratory’s response in accordance
the average of the sample scores as de- with paragraphs (c)(1) through (5) of
termined under paragraphs (c)(3) this section.
through (c)(5) of this section. (1) The program determines the re-
[57 FR 7151, Feb. 28, 1992, as amended at 68 portable viruses to be detected by di-
FR 3702, Jan. 24, 2003] rect antigen techniques or isolated by
laboratories that perform viral isola-
§ 493.919 Virology. tion procedures. To determine the ac-
(a) Types of services offered by labora- curacy of a laboratory’s response, the
tories. In virology, there are two types program must compare the labora-
of laboratories for proficiency testing tory’s response for each sample with
purposes— the response that reflects agreement of
(1) Those that only perform tests either 80 percent of ten or more referee
that directly detect viral antigens or laboratories or 80 percent or more of
structures, either in cells derived from all participating laboratories.
infected tissues or free in fluid speci- (2) To evaluate a laboratory’s re-
mens; and sponse for a particular sample, the pro-
(2) Those that are able to isolate and gram must determine a laboratory’s
identify viruses and use direct antigen type of service in accordance with
techniques. paragraph (a) of this section. A labora-
(b) Program content and frequency of tory must isolate and identify the vi-
challenge. To be approved for pro- ruses to the same extent it performs
ficiency testing in virology, a program these procedures on patient specimens.
must provide a minimum of five sam- (3) Since laboratories may incor-
ples per testing event. There must be rectly report the presence of viruses in
at least three testing events at ap- addition to the correctly identified
proximately equal intervals per year. principal virus, the grading system
The samples may be provided to the must provide a means of deducting
laboratory through mailed shipments credit for additional erroneous viruses
or, at HHS’s option, may be provided to reported. Therefore, the total number
HHS or its designee for on-site testing. of correct responses determined by
An annual program must include viral virus culture techniques submitted by
species that are the more commonly the laboratory divided by the number
identified viruses. The specific orga- of viruses present plus the number of
nisms found in the samples may vary incorrect viruses reported by the lab-
from year to year. The annual program oratory must be multiplied by 100 to
must include samples for viral antigen establish a score for each sample in
detection and viral isolation and iden- each testing event. For example, if a
tification. sample contained one principal virus
(1) An approved program must fur- and the laboratory reported it cor-
nish HHS with a description of samples rectly but reported the presence of an
that it plans to include in its annual additional virus, which was not
program no later than six months be- present, the sample grade would be 1/(1
fore each calendar year. The program + 1) × 100 = 50 percent.
must include other important emerg- (4) The performance criterion for
ing viruses (as determined by HHS) and qualitative antigen tests is presence or
viruses commonly occurring in patient absence of the viral antigen. The score
specimens. for the antigen tests is the number of
(2) An approved program may vary correct responses divided by the num-
over time. For example, the types of vi- ber of samples to be tested for the anti-
ruses that might be included in an ap- gen, multiplied by 100.
666
(5) The score for a testing event is paragraphs (b)(1) through (4) of this
the average of the sample scores as de- section.
termined under paragraph (c)(3) and (1) To determine the accuracy of a
(c)(4) of this section. laboratory’s response for qualitative
and quantitative syphilis tests, the
FR 3702, Jan. 24, 2003]
program must compare the labora-
tory’s response with the response that
§ 493.921 Diagnostic immunology. reflects agreement of either 80 percent
of ten or more referee laboratories or
The subspecialties under the spe- 80 percent or more of all participating
cialty of immunology for which a pro- laboratories. The proficiency testing
gram may offer proficiency testing are program must indicate the minimum
syphilis serology and general immu- concentration, by method, that will be
nology. Specific criteria for these sub- considered as indicating a positive re-
specialties are found at §§ 493.923 and sponse. The score for a sample in syphi-
493.927. lis serology is the average of scores de-
termined under paragraphs (b)(2) and
§ 493.923 Syphilis serology.
(b)(3) of this section.
(a) Program content and frequency of (2) For quantitative syphilis tests,
challenge. To be approved for pro- the program must determine the cor-
ficiency testing in syphilis serology, a rect response for each method by the
program must provide a minimum of distance of the response from the tar-
five samples per testing event. There get value. After the target value has
must be at least three testing events at been established for each response, the
approximately equal intervals per year. appropriateness of the response must
The samples may be provided through be determined by using fixed criteria.
mailed shipments or, at HHS’ option, The criterion for acceptable perform-
may be provided to HHS or its designee ance for quantitative syphilis serology
for on-site testing. An annual program tests is the target value ±1 dilution.
must include samples that cover the (3) The criterion for acceptable per-
full range of reactivity from highly re- formance for qualitative syphilis serol-
active to non-reactive. ogy tests is reactive or nonreactive.
(b) Evaluation of test performance. (4) To determine the overall testing
HHS approves only those programs event score, the number of correct re-
that assess the accuracy of a labora- sponses must be averaged using the fol-
tory’s responses in accordance with lowing formula:
Number of acceptable responses for all challenges

× 100 = Testing event score
Total numbber of all challenges
[57 FR 7151, Feb. 28, 1992, as amended at 58 active to nonreactive. The samples
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, may be provided through mailed ship-
2003] ments or, at HHS’ option, may be pro-
vided to HHS or its designee for on-site
§ 493.927 General immunology. testing.
(a) Program content and frequency of (b) Challenges per testing event. The
challenge. To be approved for pro- minimum number of challenges per
ficiency testing for immunology, the testing event the program must pro-
annual program must provide a min- vide for each analyte or test procedure
imum of five samples per testing event. is five. Analytes or tests for which lab-
There must be at least three testing oratory performance is to be evaluated
events at approximately equal inter- include:
vals per year. The annual program

Analyte or Test Procedure
must provide samples that cover the
full range of reactivity from highly re- Alpha-l antitrypsin
667
ER25SE06.022</MATH>
§ 493.927 42 CFR Ch. IV (10–1–17 Edition)
Alpha-fetoprotein (tumor marker) sponse, the appropriateness of the re-
Antinuclear antibody sponse must be determined by using ei-
Antistreptolysin O
Anti-human immunodeficiency virus (HIV)
ther fixed criteria or the number of
Complement C3 standard deviations (SDs) the response
Complement C4 differs from the target value.
Hepatitis markers (HBsAg, anti-HBc,
HBeAg) Criteria for Acceptable Performance
IgA
IgG The criteria for acceptable perform-
IgE ance are—
IgM
Infectious mononucleosis Criteria for acceptable per-
Analyte or test
Rheumatoid factor formance
Rubella
Alpha-1 antitrypsin ................. Target value ±3 SD.
(c) Evaluation of a laboratory’s analyte Alpha-fetoprotein (tumor Target value ±3 SD.
or test performance. HHS approves only marker).
those programs that assess the accu- Antinuclear antibody .............. Target value ±2 dilutions or
positive or negative.
racy of a laboratory’s responses in ac- Antistreptolysin O .................. Target value ±2 dilution or
cordance with paragraphs (c)(1) positive or negative.
through (5) of this section. Anti-Human Immuno- Reactive or nonreactive.
(1) To determine the accuracy of a deficiency virus.
laboratory’s response for quantitative Complement C3 ..................... Target value ±3 SD.
Complement C4 ..................... Target value ±3 SD.
and qualitative immunology tests or Hepatitis (HBsAg, anti-HBc, Reactive (positive) or non-
analytes, the program must compare HBeAg). reactive (negative).
the laboratory’s response for each IgA ......................................... Target value ±3 SD.
analyte with the response that reflects IgE ......................................... Target value ±3 SD.
agreement of either 80 percent of ten or IgG ......................................... Target value ±25%.
more referee laboratories or 80 percent IgM ......................................... Target value ±3 SD.
Infectious mononucleosis ...... Target value ±2 dilutions or
or more of all participating labora- positive or negative.
tories. The proficiency testing program Rheumatoid factor ................. Target value ±2 dilutions or
must indicate the minimum concentra- positive or negative.
tion that will be considered as indi- Rubella ................................... Target value ±2 dilutions or
immune or nonimmune or
cating a positive response. The score positive or negative.
for a sample in general immunology is
either the score determined under (3) The criterion for acceptable per-
paragraph (c)(2) or (3) of this section.
formance for qualitative general im-
(2) For quantitative immunology
munology tests is positive or negative.
analytes or tests, the program must de-
termine the correct response for each (4) To determine the analyte testing
analyte by the distance of the response event score, the number of acceptable
from the target value. After the target analyte responses must be averaged
value has been established for each re- using the following formula:
Number of acceptable responses for the analyte

× 100 = Analyte score for
Total number of challenges for the analyte the testing event
(5) To determine the overall testing sponses for all analytes must be aver-
event score, the number of correct re- aged using the following formula:


ER25SE06.022</MATH>
668
ER25SE06.023</MATH>
[57 FR 7151, Feb. 28, 1992, as amended at 58 Uric Acid
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24,
2003] (c) Evaluation of a laboratory’s analyte
or test performance. HHS approves only
§ 493.929 Chemistry. those programs that assess the accu-
racy of a laboratory’s responses in ac-
The subspecialties under the spe-
cordance with paragraphs (c)(1)
cialty of chemistry for which a pro-
through (5) of this section.
ficiency testing program may offer pro-
(1) To determine the accuracy of a
ficiency testing are routine chemistry,
laboratory’s response for qualitative
endocrinology, and toxicology. Specific
and quantitative chemistry tests or
criteria for these subspecialties are
analytes, the program must compare
listed in §§ 493.931 through 493.939.
the laboratory’s response for each
§ 493.931 Routine chemistry. analyte with the response that reflects
agreement of either 80 percent of ten or
(a) Program content and frequency of more referee laboratories or 80 percent
challenge. To be approved for pro- or more of all participating labora-
ficiency testing for routine chemistry, tories. The score for a sample in rou-
a program must provide a minimum of tine chemistry is either the score de-
five samples per testing event. There termined under paragraph (c)(2) or (3)
must be at least three testing events at of this section.
approximately equal intervals per year. (2) For quantitative chemistry tests
The annual program must provide sam- or analytes, the program must deter-
ples that cover the clinically relevant mine the correct response for each
range of values that would be expected analyte by the distance of the response
in patient specimens. The specimens from the target value. After the target
may be provided through mailed ship- value has been established for each re-
ments or, at HHS’ option, may be pro- sponse, the appropriateness of the re-
vided to HHS or its designee for on-site sponse must be determined by using ei-
testing. ther fixed criteria based on the per-
(b) Challenges per testing event. The centage difference from the target
minimum number of challenges per value or the number of standard devi-
testing event a program must provide ations (SDs) the response differs from
for each analyte or test procedure list- the target value.
ed below is five serum, plasma or blood
samples. Criteria for Acceptable Performance
Analyte or Test Procedure The criteria for acceptable perform-
Alanine aminotransferase (ALT/SGPT) ance are—
Albumin Criteria for acceptable per-
Alkaline phosphatase Analyte or test formance
Amylase
Aspartate aminotransferase (AST/SGOT) Alanine aminotransferase Target value ±20%.
Bilirubin, total (ALT/SGPT).
Albumin .................................. Target value ±10%.
Blood gas (pH, pO2, and pCO2) Alkaline phosphatase ............ Target value ±30%.
Calcium, total Amylase ................................. Target value ±30%.
Chloride Aspartate aminotransferase Target value ±20%.
Cholesterol, total (AST/SGOT).
Cholesterol, high density lipoprotein Bilirubin, total ......................... Target value ±0.4 mg/dL or
Creatine kinase ±20% (greater).
Creatine kinase, isoenzymes Blood gas pO2 ....................... Target value ±3 SD.
pCO2 ..................................... Target value ±5 mm Hg or
Creatinine ±8% (greater).
Glucose (Excluding measurements on devices pH .......................................... Target value ±0.04.
cleared by FDA for home use) Calcium, total ......................... Target value ±1.0 mg/dL.
Iron, total Chloride ................................. Target value ±5%.
Lactate dehydrogenase (LDH) Cholesterol, total .................... Target value ±10%.
LDH isoenzymes Cholesterol, high density Target value ±30%.
Magnesium lipoprotein.
Creatine kinase ...................... Target value ±30%.
Potassium Creatine kinase isoenzymes MB elevated (presence or ab-
Sodium sence) or Target value

Total Protein ±3SD.
Triglycerides Creatinine .............................. Target value ±0.3 mg/dL or
Urea Nitrogen ±15% (greater).
669
§ 493.933 42 CFR Ch. IV (10–1–17 Edition)
Criteria for acceptable per- Criteria for acceptable per-

Analyte or test Analyte or test
formance formance
Glucose (excluding glucose Target value ±6 mg/dl or Urea nitrogen ......................... Target value ±2 mg/dL or
performed on monitoring ±10% (greater). ±9% (greater).
devices cleared by FDA for Uric acid ................................. Target value ±17%.
home use.
Iron, total ................................ Target value ±20%.
Lactate dehydrogenase Target value ±20%. (3) The criterion for acceptable per-
(LDH). formance for qualitative routine chem-
LDH isoenzymes ................... LDH1/LDH2 (+ or ¥) or Tar-
get value ±30%.
istry tests is positive or negative.
Magnesium ............................ Target value ±25%. (4) To determine the analyte testing
Potassium .............................. Target value ±0.5 mmol/L. event score, the number of acceptable
Sodium ................................... Target value ±4 mmol/L.
Total Protein .......................... Target value ±10%. analyte responses must be averaged
Triglycerides .......................... Target value ±25%. using the following formula:


[57 FR 7151, Feb. 28, 1992, as amended at 68 Human Chorionic gonadotropin (excluding
FR 3702, Jan. 24, 2003] urine pregnancy tests done by visual color
comparison categorized as waived tests)
§ 493.933 Endocrinology. T3 Uptake
(a) Program content and frequency of Triiodothyronine
challenge. To be approved for pro- Thyroid-stimulating hormone
ficiency testing for endocrinology, a Thyroxine
program must provide a minimum of (c) Evaluation of a laboratory’s analyte
five samples per testing event. There or test performance. HHS approves only
must be at least three testing events at those programs that assess the accu-
approximately equal intervals per year. racy of a laboratory’s responses in ac-
The annual program must provide sam- cordance with paragraphs (c)(1)
ples that cover the clinically relevant
range of values that would be expected
(1) To determine the accuracy of a
in patient specimens. The samples may
be provided through mailed shipments laboratory’s response for qualitative
or, at HHS’ option, may be provided to and quantitative endocrinology tests
HHS or its designee for on-site testing. or analytes, a program must compare
(b) Challenges per testing event. The the laboratory’s response for each
minimum number of challenges per analyte with the response that reflects
testing event a program must provide agreement of either 80 percent of ten or
for each analyte or test procedure is more referee laboratories or 80 percent
five serum, plasma, blood, or urine or more of all participating labora-
samples. tories. The score for a sample in endo-
crinology is either the score deter-
Analyte or Test
ER25SE06.022</MATH>
mined under paragraph (c)(2) or (c)(3)

Cortisol of this section.
Free Thyroxine
670
ER25SE06.023</MATH>
(2) For quantitative endocrinology Analyte or test Criteria for acceptable per-
formance
tests or analytes, the program must de-
termine the correct response for each Cortisol ................................... Target value ±25%.
analyte by the distance of the response Free Thyroxine ...................... Target value ±3 SD.
Human Chorionic Target value ±3 SD positive
from the target value. After the target Gonadotropin (excluding or negative.
value has been established for each re- urine pregnancy tests done
sponse, the appropriateness of the re- by visual color comparison
categorized as waived
sponse must be determined by using ei- tests).
ther fixed criteria based on the per- T3 Uptake .............................. Target value ±3 SD.
centage difference from the target Triiodothyronine ..................... Target value ±3 SD.
Thyroid-stimulating hormone Target value ±3 SD.
value or the number of standard devi- Thyroxine ............................... Target value ±20% or 1.0
ations (SDs) the response differs from mcg/dL (greater).
the target value.
(3) The criterion for acceptable per-
Criteria for Acceptable Performance formance for qualitative endocrinology
tests is positive or negative.
The criteria for acceptable perform- (4) To determine the analyte testing
ance are— event score, the number of acceptable
analyte responses must be averaged
using the following formula:


[57 FR 7151, Feb. 28, 1992, as amended at 58 may be provided to HHS or its designee
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, for on-site testing.
2003] (b) Challenges per testing event. The
minimum number of challenges per
§ 493.937 Toxicology.
testing event a program must provide
(a) Program content and frequency of for each analyte or test procedure is
challenge. To be approved for pro- five serum, plasma, or blood samples.
ficiency testing for toxicology, the an-
nual program must provide a minimum Analyte or Test Procedure
of five samples per testing event. There Alcohol (blood) Phenytoin
must be at least three testing events at Blood lead Primidone
approximately equal intervals per year. Carbamazepine Procainamide
The annual program must provide sam- Digoxin (and metabolite)
ples that cover the clinically relevant Ethosuximide Quinidine
range of values that would be expected Gentamicin Theophylline
in specimens of patients on drug ther- Lithium Tobramycin
apy and that cover the level of clinical Phenobarbital Valproic Acid
significance for the particular drug.

ER25SE06.022</MATH>
(c) Evaluation of a laboratory’s analyte

The samples may be provided through or test performance. HHS approves only
mailed shipments or, at HHS’ option,
671
ER25SE06.023</MATH>
§ 493.941 42 CFR Ch. IV (10–1–17 Edition)
those programs that assess the accu- Criteria for Acceptable Performance
racy of a laboratory’s responses in ac-
The criteria for acceptable perform-
cordance with paragraphs (c)(1)
ance are:
(1) To determine the accuracy of a Analyte or test Criteria for acceptable per-
formance
laboratory’s responses for quantitative
toxicology tests or analytes, the pro- Alcohol, blood ........................ Target Value ±25%.
gram must compare the laboratory’s Blood lead .............................. Target Value ±10% or 4 mcg/
response for each analyte with the re- dL (greater).
Carbamazepine ..................... Target Value ±25%.
sponse that reflects agreement of ei- Digoxin ................................... Target Value ±20% or ±0.2
ther 80 percent of ten or more referee ng/mL (greater).
laboratories or 80 percent or more of Ethosuximide ......................... Target Value ±20%.
Gentamicin ............................. Target Value ±25%.
all participating laboratories. The Lithium ................................... Target Value ±0.3 mmol/L or
score for a sample in toxicology is the ±20% (greater).
score determined under paragraph Phenobarbital ......................... Target Value ±20%
(c)(2) of this section. Phenytoin ............................... Target Value ±25%.
Primidone ............................... Target Value ±25%.
(2) For quantitative toxicology tests Procainamide (and metabo- Target Value ±25%.
or analytes, the program must deter- lite).
mine the correct response for each Quinidine ................................ Target Value ±25%.
Tobramycin ............................ Target Value ±25%.
analyte by the distance of the response Theophylline .......................... Target Value ±25%.
from the target value. After the target Valproic Acid .......................... Target Value ±25%.
value has been established for each re-
sponse, the appropriateness of the re- (3) To determine the analyte testing
sponse must be determined by using event score, the number of acceptable
fixed criteria based on the percentage analyte responses must be averaged
difference from the target value using the following formula:


[57 FR 7151, Feb. 28, 1992, as amended at 58 that would be expected in patient
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, specimens. The samples may be pro-
2003] vided through mailed shipments or, at
HHS’ option, may be provided to HHS
§ 493.941 Hematology (including rou- and or its designee for on-site testing.
tine hematology and coagulation).
(b) Challenges per testing event. The
(a) Program content and frequency of minimum number of challenges per
challenge. To be approved for pro- testing event a program must provide
ficiency testing for hematology, a pro- for each analyte or test procedure is
gram must provide a minimum of five five.
samples per testing event. There must
be at least three testing events at ap- Analyte or Test Procedure
ER25SE06.022</MATH>
proximately equal intervals per year. Cell identification or white blood cell dif-
The annual program must provide sam- ferential
ples that cover the full range of values Erythrocyte count
672
ER25SE06.023</MATH>
Hematocrit (excluding spun microhemato- (2) For quantitative hematology tests
crit) or analytes, the program must deter-
Hemoglobin mine the correct response for each
Leukocyte count
Platelet count analyte by the distance of the response
Fibrinogen from the target value. After the target
Partial thromboplastin time value has been established for each re-
Prothrombin time sponse, the appropriateness of the re-
(1) An approved program for cell sponse is determined using either fixed
identification may vary over time. The criteria based on the percentage dif-
types of cells that might be included in ference from the target value or the
an approved program over time are— number of standard deviations (SDs)
the response differs from the target
Neutrophilic granulocytes value.
Eosinophilic granulocytes
Basophilic granulocytes Criteria for Acceptable Performance
Lymphocytes
Monocytes The criteria for acceptable perform-
Major red and white blood cell abnormalities ance are:
Immature red and white blood cells
Criteria for acceptable per-
(2) White blood cell differentials Analyte or test formance
should be limited to the percentage
distribution of cellular elements listed Cell identification ................... 90% or greater consensus on
identification.
above. White blood cell differential ... Target ±3SD based on the
(c) Evaluation of a laboratory’s analyte percentage of different
or test performance. HHS approves only types of white blood cells
those programs that assess the accu- in the samples.
Erythrocyte count ................... Target ±6%.
racy of a laboratory’s responses in ac- Hematocrit (Excluding spun Target ±6%.
cordance with paragraphs (c) (1) hematocrits).
through (5) of this section. Hemoglobin ............................ Target ±7%.
(1) To determine the accuracy of a Leukocyte count .................... Target ±15%.
Platelet count ......................... Target ±25%.
laboratory’s responses for qualitative Fibrinogen .............................. Target ±20%.
and quantitative hematology tests or Partial thromboplastin time .... Target ±15%.
analytes, the program must compare Prothrombin time ................... Target ±15%.
the laboratory’s response for each
analyte with the response that reflects (3) The criterion for acceptable per-
agreement of either 80 percent of ten or formance for the qualitative hema-
more referee laboratories or 80 percent tology test is correct cell identifica-
or more of all participating labora- tion.
tories. The score for a sample in hema- (4) To determine the analyte testing
tology is either the score determined event score, the number of acceptable
under paragraph (c) (2) or (3) of this analyte responses must be averaged
section. using the following formula:


ER25SE06.022</MATH>
673
ER25SE06.023</MATH>
§ 493.945 42 CFR Ch. IV (10–1–17 Edition)
[57 FR 7151, Feb. 28, 1992, as amended at 58 (b)(3)(ii)(A) of this section. For all slide
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, preparations, a 100% consensus agree-
2003] ment among a minimum of three phy-
§ 493.945 Cytology; gynecologic exami- sicians certified in anatomic pathology
nations. is required. In addition, for
premalignant and malignant slide
(a) Program content and frequency of preparations, confirmation by tissue
challenge. (1) To be approved for pro- biopsy is required either by comparison
ficiency testing for gynecologic exami- of the reported biopsy results or re-
nations (Pap smears) in cytology, a evaluation of biopsy slide material by
program must provide test sets com-
a physician certified in anatomic pa-
posed of 10- and 20-glass slides. Pro-
thology.
ficiency testing programs may obtain
slides for test sets from cytology lab- (2) An individual qualified as a tech-
oratories, provided the slides have been nical supervisor under § 493.1449 (b) or
retained by the laboratory for the re- (k) who routinely interprets
quired period specified in gynecologic slide preparations only
§§ 493.1105(a)(7)(i)(A) and 493.1274(f)(2). If after they have been examined by a
slide preparations are still subject to cytotechnologist can either be tested
retention by the laboratory, they may using a test set that has been screened
be loaned to a proficiency testing pro- by a cytotechnologist in the same lab-
gram if the program provides the laboratory or using a test set that has not
oratory with documentation of the been screened. A technical supervisor
loan of the slides and ensures that who screens and interprets slide prep-
slides loaned to it are retrievable upon arations that have not been previously
request. Each test set must include at examined must be tested using a test
least one slide representing each of the set that has not been previously
response categories described in para- screened.
graph (b)(3)(ii)(A) of this section, and (3) The criteria for acceptable per-
test sets should be comparable so that formance are determined by using the
equitable testing is achieved within scoring system in paragraphs (b)(3) (i)
and between proficiency testing pro- and (ii) of this section.
viders. (i) Each slide set must contain 10 or
(2) To be approved for proficiency 20 slides with point values established
testing in gynecologic cytology, a pro- for each slide preparation based on the
gram must provide announced and un- significance of the relationship of the
announced on-site testing for each in- interpretation of the slide to a clinical
dividual at least once per year and condition and whether the participant
must provide an initial retesting event in the testing event is a
for each individual within 45 days after cytotechnologist qualified under
notification of test failure and subse- § 493.1469 or § 493.1483 or functioning as a
quent retesting events within 45 days technical supervisor in cytology quali-
after completion of remedial action de- fied under § 493.1449 (b) or (k) of this
scribed in § 493.855. part.
(b) Evaluation of an individual’s per- (ii) The scoring system rewards or pe-
formance. HHS approves only those pro- nalizes the participants in proportion
grams that assess the accuracy of each to the distance of their answers from
individual’s responses on both 10- and the correct response or target diag-
20-slide test sets in which the slides nosis and the penalty or reward is
have been referenced as specified in weighted in proportion to the severity
paragraph (b)(1) of this section. of the lesion.
(1) To determine the accuracy of an (A) The four response categories for
individual’s response on a particular reporting proficiency testing results
challenge (slide), the program must and their descriptions are as follows:
compare the individual’s response for
each slide preparation with the re- Category Description
sponse that reflects the predetermined
consensus agreement or confirmation A ............... Unsatisfactory for diagnosis due to:

on the diagnostic category, as de- (1) Scant cellularity.
scribed in the table in paragraph (2) Air drying.
674
Category Description Examinee’s response: A B C D
(3) Obscuring material (blood, inflam- Correct response category:

A ................................................. 10 0 0 0
matory cells, or lubricant).
B ................................................. 5 10 0 0
B ............... Normal or Benign Changes—includes: C ................................................. 5 0 10 5
(1) Normal, negative or within normal D ................................................. 0 ¥5 5 10
limits.
(2) Infection other than Human
(D) Criteria for scoring system for a
Papillomavirus (HPV) (e.g.,
Trichomonas vaginalis, changes or 10-slide test set. (See table at para-
morphology consistent with Candida graph (b)(3)(ii)(A) of this section for a
spp., Actinomyces spp. or Herpes description of the response categories.)
simplex virus). For cytotechnologists qualified under
(3) Reactive and reparative changes § 493.1469 or § 493.1483:
(e.g., inflammation, effects of chem-
otherapy or radiation). Examinee’s response: A B C D
C ............... Low Grade Squamous Intraepithelial
Correct response category:
Lesion—includes:
A ................................................. 10 0 5 5
(1) Cellular changes associated with B ................................................. 5 10 5 5
HPV. C ................................................. 5 0 10 10
(2) Mild dysplasia/CIN–1. D ................................................. 0 ¥5 10 10
D ............... High Grade Lesion and Carcinoma—
includes: (E) In accordance with the criteria
(1) High grade squamous for the scoring system, the charts in
intraepithelial lesions which include
moderate dysplasia/CIN–2 and se-
paragraphs (b)(3)(ii)(F) and (G) of this
vere dysplasia/carcinoma in-situ/ section, for technical supervisors and
CIN–3. cytotechnologists, respectively, pro-
(2) Squamous cell carcinoma. vide maximums of 5 points for a cor-
(3) Adenocarcinoma and other malig- rect response and minus ten (¥10)
nant neoplasms. points for an incorrect response on a
20-slide test set.
(B) In accordance with the criteria (F) Criteria for scoring system for a
for the scoring system, the charts in 20-slide test set. (See table at para-
paragraphs (b)(3)(ii)(C) and (D) of this graph (b)(3)(ii)(A) of this section for a
section, for technical supervisors and description of the response categories.)
cytotechnologists, respectively, pro- For technical supervisors qualified
vide a maximum of 10 points for a cor- under § 493.1449(b) or (k):
rect response and a maximum of minus
five (¥5) points for an incorrect re- Examinee’s response: A B C D
sponse on a 10-slide test set. For exam- Correct response category:
ple, if the correct response on a slide is A ........................................... 5 0 0 0
‘‘high grade squamous intraepithelial B ........................................... 2.5 5 0 0
lesion’’ (category ‘‘D’’ on the scoring C .......................................... 2.5 0 5 2.5
D .......................................... 0 ¥10 2.5 5
system chart) and an examinee calls it
‘‘normal or negative’’ (category ‘‘B’’ on
(G) Criteria for scoring system for a
the scoring system chart), then the
20-slide test set. (See table at
examinee’s point value on that slide is
(b)(3)(ii)(A) of this section for a de-
calculated as minus five (¥5). Each
scription of the response categories.)
slide is scored individually in the same
For cytotechnologists qualified under
manner. The individual’s score for the
§ 493.1469 or § 493.1483:
testing event is determined by adding
the point value achieved for each slide Examinee’s response: A B C D
preparation, dividing by the total
Correct response category:
points for the testing event and multi- A ......................................... 5 0 2.5 2.5
plying by 100. B ......................................... 2.5 5 2.5 2.5
(C) Criteria for scoring system for a C ......................................... 2.5 0 5 5
10-slide test set. (See table at D ......................................... 0 ¥10 5 5
(b)(3)(ii)(A) of this section for a de-
scription of the response categories.) [57 FR 7151, Feb. 28, 1992, as amended at 58
For technical supervisors qualified FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24,
under § 493.1449(b) or (k): 2003]
675
§ 493.959 42 CFR Ch. IV (10–1–17 Edition)
§ 493.959 Immunohematology. those programs that assess the accu-

racy of a laboratory’s response in ac-
(a) Types of services offered by labora-
tories. In immunohematology, there are cordance with paragraphs (d)(1)
four types of laboratories for pro- through (5) of this section.
ficiency testing purposes— (1) To determine the accuracy of a
(1) Those that perform ABO group laboratory’s response, a program must
and/or D (Rho) typing; compare the laboratory’s response for
(2) Those that perform ABO group each analyte with the response that re-
and/or D (Rho) typing, and unexpected flects agreement of either 100 percent
antibody detection; of ten or more referee laboratories or
(3) Those that in addition to para- 95 percent or more of all participating
graph (a)(2) of this section perform laboratories except for unexpected
compatibility testing; and antibody detection and antibody iden-
(4) Those that perform in addition to tification. To determine the accuracy
paragraph (a)(3) of this section anti- of a laboratory’s response for unex-
body identification. pected antibody detection and antibody
(b) Program content and frequency of identification, a program must com-
challenge. To be approved for pro- pare the laboratory’s response for each
ficiency testing for analyte with the response that reflects
immunohematology, a program must agreement of either 95 percent of ten or
provide a minimum of five samples per more referee laboratories or 95 percent
testing event. There must be at least or more of all participating labora-
three testing events at approximately tories. The score for a sample in
equal intervals per year. The annual immunohematology is either the score
program must provide samples that determined under paragraph (d)(2) or
cover the full range of interpretation (3) of this section.
that would be expected in patient (2) Criteria for acceptable performance.
specimens. The samples may be pro- The criteria for acceptable perform-
vided through mailed shipments or, at ance are—
HHS’ option, may be provided to HHS
Criteria for acceptable per-
or its designee for on-site testing. Analyte or test formance
(c) Challenges per testing event. The
minimum number of challenges per ABO group .............................. 100% accuracy.
D (Rho) typing ......................... 100% accuracy.
testing event a program must provide Unexpected antibody detection 80% accuracy.
for each analyte or test procedure is Compatibility testing ................ 100% accuracy.
five. Antibody identification ............. 80% accuracy.
Analyte or Test Procedure

(3) The criterion for acceptable per-
ABO group (excluding subgroups) formance for qualitative
D (Rho) typing immunohematology tests is positive or
Unexpected antibody detection negative.
Compatibility testing (4) To determine the analyte testing
Antibody identification
event score, the number of acceptable
(d) Evaluation of a laboratory’s analyte analyte responses must be averaged
or test performance. HHS approves only using the following formula:

676
ER25SE06.023</MATH>

Subpart J—Facility Administration § 493.1103 Standard: Requirements for

for Nonwaived Testing transfusion services.
A facility that provides transfusion
SOURCE: 68 FR 3703, Jan. 24, 2003, unless services must meet all of the require-
otherwise noted. ments of this section and document all
transfusion-related activities.
§ 493.1100 Condition: Facility adminis- (a) Arrangement for services. The facil-
tration. ity must have a transfusion service
Each laboratory that performs non- agreement reviewed and approved by
waived testing must meet the applica- the responsible party(ies) that govern
ble requirements under §§ 493.1101 the procurement, transfer, and avail-
through 493.1105, unless HHS approves a ability of blood and blood products.
procedure that provides equivalent (b) Provision of testing. The facility
quality testing as specified in Appendix must provide prompt ABO grouping,
C of the State Operations Manual (CMS D(Rho) typing, unexpected antibody
Pub. 7). detection, compatibility testing, and
laboratory investigation of transfusion
§ 493.1101 Standard: Facilities. reactions on a continuous basis
through a CLIA-certified laboratory or
(a) The laboratory must be con- a laboratory meeting equivalent re-
structed, arranged, and maintained to quirements as determined by CMS.
ensure the following: (c) Blood and blood products storage
(1) The space, ventilation, and utili- and distribution. (1) If a facility stores
ties necessary for conducting all phases or maintains blood or blood products
of the testing process. for transfusion outside of a monitored
(2) Contamination of patient speci- refrigerator, the facility must ensure
mens, equipment, instruments, re- the storage conditions, including tem-
agents, materials, and supplies is mini- perature, are appropriate to prevent
mized. deterioration of the blood or blood
(3) Molecular amplification proce- product.
dures that are not contained in closed (2) The facility must establish and
systems have a uni-directional follow policies to ensure positive iden-
workflow. This must include separate tification of a blood or blood product
areas for specimen preparation, ampli- beneficiary.
fication and product detection, and, as (d) Investigation of transfusion reac-
applicable, reagent preparation. tions. The facility must have proce-
(b) The laboratory must have appro- dures for preventing transfusion reac-
priate and sufficient equipment, instru- tions and when necessary, promptly
ments, reagents, materials, and sup- identify, investigate, and report blood
plies for the type and volume of testing and blood product transfusion reac-
it performs. tions to the laboratory and, as appro-
(c) The laboratory must be in compli- priate, to Federal and State authori-
ance with applicable Federal, State, ties.
and local laboratory requirements.
(d) Safety procedures must be estab- § 493.1105 Standard: Retention re-
lished, accessible, and observed to en- quirements.
sure protection from physical, chem- (a) The laboratory must retain its
ical, biochemical, and electrical haz- records and, as applicable, slides,
ards, and biohazardous materials. blocks, and tissues as follows:
(e) Records and, as applicable, slides, (1) Test requisitions and authorizations.
blocks, and tissues must be maintained Retain records of test requisitions and
and stored under conditions that en- test authorizations, including the pa-
sure proper preservation. tient’s chart or medical record if used
677
ER25SE06.022</MATH>
§ 493.1200 42 CFR Ch. IV (10–1–17 Edition)
as the test requisition or authoriza- (b) If the laboratory ceases operation,

tion, for at least 2 years. the laboratory must make provisions
(2) Test procedures. Retain a copy of to ensure that all records and, as appli-
each test procedure for at least 2 years cable, slides, blocks, and tissue are re-
after a procedure has been discon- tained and available for the time
tinued. Each test procedure must in- frames specified in this section.
clude the dates of initial use and dis- [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22,
continuance. 2003]
(3) Analytic systems records. Retain
quality control and patient test Subpart K—Quality System for
records (including instrument print- Nonwaived Testing
outs, if applicable) and records docu-
menting all analytic systems activities
SOURCE: 68 FR 3703, Jan. 24, 2003, unless
specified in §§ 493.1252 through 493.1289
otherwise noted.
for at least 2 years. In addition, retain
the following: § 493.1200 Introduction.
(i) Records of test system perform-
(a) Each laboratory that performs
ance specifications that the laboratory
nonwaived testing must establish and
establishes or verifies under § 493.1253
maintain written policies and proce-
for the period of time the laboratory
dures that implement and monitor a
uses the test system but no less than 2
quality system for all phases of the
years.
total testing process (that is,
(ii) Immunohematology records, preanalytic, analytic, and
blood and blood product records, and postanalytic) as well as general labora-
transfusion records as specified in 21 tory systems.
CFR 606.160(b)(3)(ii), (b)(3)(iv), (b)(3)(v) (b) The laboratory’s quality systems
and (d). must include a quality assessment
(4) Proficiency testing records. Retain component that ensures continuous
all proficiency testing records for at improvement of the laboratory’s per-
least 2 years. formance and services through ongoing
(5) Quality system assessment records. monitoring that identifies, evaluates
Retain all laboratory quality systems and resolves problems.
assessment records for at least 2 years. (c) The various components of the
(6) Test reports. Retain or be able to laboratory’s quality system are used to
retrieve a copy of the original report meet the requirements in this part and
(including final, preliminary, and cor- must be appropriate for the specialties
rected reports) at least 2 years after and subspecialties of testing the lab-
the date of reporting. In addition, re- oratory performs, services it offers, and
tain the following: clients it serves.
(i) Immunohematology reports as
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
specified in 21 CFR 606.160(d). 2003]
(ii) Pathology test reports for at
least 10 years after the date of report- § 493.1201 Condition: Bacteriology.
ing. If the laboratory provides services in
(7) Slide, block, and tissue retention—(i) the subspecialty of Bacteriology, the
Slides. (A) Retain cytology slide prep- laboratory must meet the require-
arations for at least 5 years from the ments specified in §§ 493.1230 through
date of examination (see § 493.1274(f) for 493.1256, § 493.1261, and §§ 493.1281
proficiency testing exception). through 493.1299.
(B) Retain histopathology slides for
at least 10 years from the date of exam- § 493.1202 Condition:
ination. Mycobacteriology.
(ii) Blocks. Retain pathology speci- If the laboratory provides services in
men blocks for at least 2 years from the subspecialty of Mycobacteriology,
the date of examination. the laboratory must meet the require-
(iii) Tissue. Preserve remnants of tis- ments specified in §§ 493.1230 through

sue for pathology examination until a 493.1256, § 493.1262, and §§ 493.1281
diagnosis is made on the specimen. through 493.1299.
678
§ 493.1203 Condition: Mycology. § 493.1212 Condition: Endocrinology.

If the laboratory provides services in If the laboratory provides services in
the subspecialty of Mycology, the lab- the subspecialty of Endocrinology, the
oratory must meet the requirements laboratory must meet the require-
specified in §§ 493.1230 through 493.1256, ments specified in §§ 493.1230 through
§ 493.1263, and §§ 493.1281 through 493.1256, and §§ 493.1281 through 493.1299.
493.1299.
§ 493.1213 Condition: Toxicology.
§ 493.1204 Condition: Parasitology. If the laboratory provides services in
If the laboratory provides services in the subspecialty of Toxicology, the lab-
the subspecialty of Parasitology, the oratory must meet the requirements
laboratory must meet the require- specified in §§ 493.1230 through 493.1256,
ments specified in §§ 493.1230 through and §§ 493.1281 through 493.1299.
493.1256, § 493.1264, and §§ 493.1281
through 493.1299. § 493.1215 Condition: Hematology.
If the laboratory provides services in
§ 493.1205 Condition: Virology. the specialty of Hematology, the lab-
If the laboratory provides services in oratory must meet the requirements
the subspecialty of Virology, the lab- specified in §§ 493.1230 through 493.1256,
oratory must meet the requirements § 493.1269, and §§ 493.1281 through
specified in §§ 493.1230 through 493.1256, 493.1299.
§ 493.1265, and §§ 493.1281 through
§ 493.1217 Condition:
493.1299. Immunohematology.
§ 493.1207 Condition: Syphilis serology. If the laboratory provides services in
the specialty of Immunohematology,
the laboratory must meet the require-
the subspecialty of Syphilis serology,
ments specified in §§ 493.1230 through
493.1256, § 493.1271, and §§ 493.1281
through 493.1299.
493.1256, and §§ 493.1281 through 493.1299.
§ 493.1219 Condition: Histopathology.
§ 493.1208 Condition: General immu-
nology. If the laboratory provides services in
the subspecialty of Histopathology, the
laboratory must meet the require-
the subspecialty of General immu-
nology, the laboratory must meet the
493.1256, § 493.1273, and §§ 493.1281
requirements specified in §§ 493.1230
through 493.1299.
through 493.1256, and §§ 493.1281 through
493.1299. § 493.1220 Condition: Oral pathology.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, If the laboratory provides services in
2003] the subspecialty of Oral pathology, the
laboratory must meet the require-
§ 493.1210 Condition: Routine chem- ments specified in §§ 493.1230 through
istry.
493.1256, and §§ 493.1281 through 493.1299.
the subspecialty of Routine chemistry, § 493.1221 Condition: Cytology.
the laboratory must meet the require- If the laboratory provides services in
ments specified in §§ 493.1230 through the subspecialty of Cytology, the lab-
493.1256, § 493.1267, and §§ 493.1281 oratory must meet the requirements
through 493.1299. specified in §§ 493.1230 through 493.1256,
§ 493.1274, and §§ 493.1281 through
§ 493.1211 Condition: Urinalysis. 493.1299.
the subspecialty of Urinalysis, the lab- § 493.1225 Condition: Clinical cyto-
oratory must meet the requirements genetics.

specified in §§ 493.1230 through 493.1256, If the laboratory provides services in
and §§ 493.1281 through 493.1299. the specialty of Clinical cytogenetics,
679
§ 493.1226 42 CFR Ch. IV (10–1–17 Edition)
the laboratory must meet the require- § 493.1233 Standard: Complaint inves-
ments specified in §§ 493.1230 through tigations.
493.1256, § 493.1276, and §§ 493.1281 The laboratory must have a system
through 493.1299. in place to ensure that it documents all
complaints and problems reported to
§ 493.1226 Condition: Radiobioassay.
the laboratory. The laboratory must
If the laboratory provides services in conduct investigations of complaints,
the specialty of Radiobioassay, the lab- when appropriate.
oratory must meet the requirements
specified in §§ 493.1230 through 493.1256, § 493.1234 Standard: Communications.
and §§ 493.1281 through 493.1299. The laboratory must have a system
in place to identify and document prob-
§ 493.1227 Condition: lems that occur as a result of a break-
Histocompatibility.
down in communication between the
If the laboratory provides services in laboratory and an authorized person
the specialty of Histocompatibility, who orders or receives test results.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
ments specified in §§ 493.1230 through 2003]
493.1256, § 493.1278, and §§ 493.1281
through 493.1299. § 493.1235 Standard: Personnel com-
petency assessment policies.
GENERAL LABORATORY SYSTEMS
As specified in the personnel require-
§ 493.1230 Condition: General labora- ments in subpart M, the laboratory
tory systems. must establish and follow written poli-
cies and procedures to assess employee
Each laboratory that performs non- and, if applicable, consultant com-
waived testing must meet the applica- petency.
ble general laboratory systems require-
ments in §§ 493.1231 through 493.1236, un- § 493.1236 Standard: Evaluation of pro-
less HHS approves a procedure, speci- ficiency testing performance.
fied in Appendix C of the State Oper- (a) The laboratory must review and
ations Manual (CMS Pub. 7), that pro- evaluate the results obtained on pro-
vides equivalent quality testing. The ficiency testing performed as specified
laboratory must monitor and evaluate in subpart H of this part.
the overall quality of the general lab- (b) The laboratory must verify the
oratory systems and correct identified accuracy of the following:
problems as specified in § 493.1239 for (1) Any analyte or subspecialty with-
each specialty and subspecialty of test- out analytes listed in subpart I of this
ing performed. part that is not evaluated or scored by
a CMS-approved proficiency testing
§ 493.1231 Standard: Confidentiality of
patient information. program.
(2) Any analyte, specialty or sub-
The laboratory must ensure confiden- specialty assigned a proficiency testing
tiality of patient information through- score that does not reflect laboratory
out all phases of the total testing proc- test performance (that is, when the
ess that are under the laboratory’s con- proficiency testing program does not
trol. obtain the agreement required for scor-
ing as specified in subpart I of this
§ 493.1232 Standard: Specimen identi- part, or the laboratory receives a zero
fication and integrity. score for nonparticipation, or late re-
The laboratory must establish and turn of results).
follow written policies and procedures (c) At least twice annually, the lab-
that ensure positive identification and oratory must verify the accuracy of
optimum integrity of a patient’s speci- the following:
men from the time of collection or re- (1) Any test or procedure it performs
ceipt of the specimen through comple- that is not included in subpart I of this
tion of testing and reporting of results. part.
680
(2) Any test or procedure listed in and maintains the authorization or

subpart I of this part for which com- documentation of its efforts to obtain
patible proficiency testing samples are the authorization.
not offered by a CMS-approved pro- (c) The laboratory must ensure the
ficiency testing program. test requisition solicits the following
(d) All proficiency testing evaluation information:
and verification activities must be doc- (1) The name and address or other
umented. suitable identifiers of the authorized
person requesting the test and, if ap-
§ 493.1239 Standard: General labora- propriate, the individual responsible
tory systems quality assessment. for using the test results, or the name
(a) The laboratory must establish and address of the laboratory submit-
and follow written policies and proce- ting the specimen, including, as appli-
dures for an ongoing mechanism to cable, a contact person to enable the
monitor, assess, and, when indicated, reporting of imminently life threat-
correct problems identified in the gen- ening laboratory results or panic or
eral laboratory systems requirements alert values.
specified at §§ 493.1231 through 493.1236. (2) The patient’s name or unique pa-
(b) The general laboratory systems tient identifier.
quality assessment must include a re- (3) The sex and age or date of birth of
view of the effectiveness of corrective the patient.
actions taken to resolve problems, re- (4) The test(s) to be performed.
vision of policies and procedures nec- (5) The source of the specimen, when
essary to prevent recurrence of prob- appropriate.
lems, and discussion of general labora- (6) The date and, if appropriate, time
tory systems quality assessment re- of specimen collection.
views with appropriate staff. (7) For Pap smears, the patient’s last
(c) The laboratory must document all menstrual period, and indication of
general laboratory systems quality as- whether the patient had a previous ab-
sessment activities. normal report, treatment, or biopsy.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, (8) Any additional information rel-
2003] evant and necessary for a specific test
to ensure accurate and timely testing
PREANALYTIC SYSTEMS and reporting of results, including in-
terpretation, if applicable.
§ 493.1240 Condition: Preanalytic sys- (d) The patient’s chart or medical
tems. record may be used as the test requisi-
Each laboratory that performs non- tion or authorization but must be
waived testing must meet the applica- available to the laboratory at the time
ble preanalytic system(s) requirements of testing and available to CMS or a
in §§ 493.1241 and 493.1242, unless HHS CMS agent upon request.
approves a procedure, specified in Ap- (e) If the laboratory transcribes or
pendix C of the State Operations Man- enters test requisition or authorization
ual (CMS Pub. 7), that provides equiva- information into a record system or a
lent quality testing. The laboratory laboratory information system, the
must monitor and evaluate the overall laboratory must ensure the informa-
quality of the preanalytic systems and tion is transcribed or entered accu-
correct identified problems as specified rately.
in § 493.1249 for each specialty and sub-
specialty of testing performed. § 493.1242 Standard: Specimen submis-
sion, handling, and referral.
§ 493.1241 Standard: Test request. (a) The laboratory must establish
(a) The laboratory must have a writ- and follow written policies and proce-
ten or electronic request for patient dures for each of the following, if appli-
testing from an authorized person. cable:
(b) The laboratory may accept oral (1) Patient preparation.
requests for laboratory tests if it solic- (2) Specimen collection.

its a written or electronic authoriza- (3) Specimen labeling, including pa-
tion within 30 days of the oral request tient name or unique patient identifier
681
§ 493.1249 42 CFR Ch. IV (10–1–17 Edition)
and, when appropriate, specimen ual (CMS Pub. 7), that provides equiva-
source. lent quality testing. The laboratory
(4) Specimen storage and preserva- must monitor and evaluate the overall
tion. quality of the analytic systems and
(5) Conditions for specimen transpor- correct identified problems as specified
tation. in § 493.1289 for each specialty and sub-
(6) Specimen processing. specialty of testing performed.
(7) Specimen acceptability and rejec-
tion. § 493.1251 Standard: Procedure man-
(8) Specimen referral. ual.
(b) The laboratory must document (a) A written procedure manual for
the date and time it receives a speci- all tests, assays, and examinations per-
men. formed by the laboratory must be
(c) The laboratory must refer a speci- available to, and followed by, labora-
men for testing only to a CLIA-cer- tory personnel. Textbooks may supple-
tified laboratory or a laboratory meet- ment but not replace the laboratory’s
ing equivalent requirements as deter- written procedures for testing or exam-
mined by CMS. ining specimens.
(d) If the laboratory accepts a refer- (b) The procedure manual must in-
ral specimen, written instructions clude the following when applicable to
must be available to the laboratory’s the test procedure:
clients and must include, as appro- (1) Requirements for patient prepara-
priate, the information specified in tion; specimen collection, labeling,
paragraphs (a)(1) through (a)(7) of this storage, preservation, transportation,
section. processing, and referral; and criteria
for specimen acceptability and rejec-
§ 493.1249 Standard: Preanalytic sys- tion as described in § 493.1242.
tems quality assessment.
(2) Microscopic examination, includ-
(a) The laboratory must establish ing the detection of inadequately pre-
and follow written policies and proce- pared slides.
dures for an ongoing mechanism to (3) Step-by-step performance of the
monitor, assess, and when indicated, procedure, including test calculations
correct problems identified in the and interpretation of results.
preanalytic systems specified at (4) Preparation of slides, solutions,
§§ 493.1241 through 493.1242. calibrators, controls, reagents, stains,
(b) The preanalytic systems quality and other materials used in testing.
assessment must include a review of (5) Calibration and calibration
the effectiveness of corrective actions verification procedures.
taken to resolve problems, revision of (6) The reportable range for test re-
policies and procedures necessary to sults for the test system as established
prevent recurrence of problems, and or verified in § 493.1253.
discussion of preanalytic systems qual- (7) Control procedures.
ity assessment reviews with appro- (8) Corrective action to take when
priate staff. calibration or control results fail to
(c) The laboratory must document all meet the laboratory’s criteria for ac-
preanalytic systems quality assess- ceptability.
ment activities. (9) Limitations in the test method-
[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, ology, including interfering substances.
2003] (10) Reference intervals (normal val-
ues).
ANALYTIC SYSTEMS (11) Imminently life-threatening test
results, or panic or alert values.
§ 493.1250 Condition: Analytic systems. (12) Pertinent literature references.
Each laboratory that performs non- (13) The laboratory’s system for en-
waived testing must meet the applica- tering results in the patient record and
ble analytic systems requirements in reporting patient results including,
§§ 493.1251 through 493.1283, unless HHS when appropriate, the protocol for re-
approves a procedure, specified in Ap- porting imminently life-threatening
pendix C of the State Operations Man- results, or panic, or alert values.
682
(14) Description of the course of ac- (1) Identity and when significant,
tion to take if a test system becomes titer, strength or concentration.
inoperable. (2) Storage requirements.
(c) Manufacturer’s test system in- (3) Preparation and expiration dates.
structions or operator manuals may be (4) Other pertinent information re-
used, when applicable, to meet the required for proper use.
quirements of paragraphs (b)(1) (d) Reagents, solutions, culture
through (b)(12) of this section. Any of media, control materials, calibration
the items under paragraphs (b)(1) materials, and other supplies must not
through (b)(12) of this section not pro- be used when they have exceeded their
vided by the manufacturer must be expiration date, have deteriorated, or
provided by the laboratory. are of substandard quality.
(d) Procedures and changes in proce- (e) Components of reagent kits of dif-
dures must be approved, signed, and ferent lot numbers must not be inter-
dated by the current laboratory direc- changed unless otherwise specified by
tor before use. the manufacturer.
(e) The laboratory must maintain a
copy of each procedure with the dates § 493.1253 Standard: Establishment
and verification of performance
of initial use and discontinuance as de- specifications.
scribed in § 493.1105(a)(2).
(a) Applicability. Laboratories are not
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, required to verify or establish perform-
2003] ance specifications for any test system
used by the laboratory before April 24,
§ 493.1252 Standard: Test systems,
equipment, instruments, reagents, 2003.
materials, and supplies. (b)(1) Verification of performance speci-
fications. Each laboratory that intro-
(a) Test systems must be selected by duces an unmodified, FDA-cleared or
the laboratory. The testing must be approved test system must do the fol-
performed following the manufactur- lowing before reporting patient test re-
er’s instructions and in a manner that sults:
provides test results within the labora- (i) Demonstrate that it can obtain
tory’s stated performance specifica- performance specifications comparable
tions for each test system as deter- to those established by the manufac-
mined under § 493.1253. turer for the following performance
(b) The laboratory must define cri- characteristics:
teria for those conditions that are es- (A) Accuracy.
sential for proper storage of reagents (B) Precision.
and specimens, accurate and reliable (C) Reportable range of test results
test system operation, and test result for the test system.
reporting. The criteria must be con- (ii) Verify that the manufacturer’s
sistent with the manufacturer’s in- reference intervals (normal values) are
structions, if provided. These condi- appropriate for the laboratory’s pa-
tions must be monitored and docu- tient population.
mented and, if applicable, include the (2) Establishment of performance speci-
following: fications. Each laboratory that modifies
(1) Water quality. an FDA-cleared or approved test sys-
(2) Temperature. tem, or introduces a test system not
(3) Humidity. subject to FDA clearance or approval
(4) Protection of equipment and in- (including methods developed in-house
struments from fluctuations and inter- and standardized methods such as text
ruptions in electrical current that ad- book procedures), or uses a test system
versely affect patient test results and in which performance specifications
test reports. are not provided by the manufacturer
(c) Reagents, solutions, culture must, before reporting patient test re-
media, control materials, calibration sults, establish for each test system
materials, and other supplies, as appro- the performance specifications for the
priate, must be labeled to indicate the following performance characteristics,
following: as applicable:
683
§ 493.1254 42 CFR Ch. IV (10–1–17 Edition)
(i) Accuracy. ment, and test system performance

(ii) Precision. that is necessary for accurate and reli-
(iii) Analytical sensitivity. able test results and test result report-
(iv) Analytical specificity to include ing.
interfering substances. (ii) Perform and document the func-
(v) Reportable range of test results tion checks, including background or
for the test system. baseline checks, specified in paragraph
(vi) Reference intervals (normal val- (b)(2)(i) of this section. Function
ues). checks must be within the laboratory’s
(vii) Any other performance char- established limits before patient test-
acteristic required for test performing is conducted.
ance.
(3) Determination of calibration and § 493.1255 Standard: Calibration and
control procedures. The laboratory must calibration verification procedures.
determine the test system’s calibration Calibration and calibration
procedures and control procedures verification procedures are required to
based upon the performance specifica- substantiate the continued accuracy of
tions verified or established under the test system throughout the labora-
paragraph (b)(1) or (b)(2) of this sec- tory’s reportable range of test results
tion. for the test system. Unless otherwise
(c) Documentation. The laboratory specified in this subpart, for each ap-
must document all activities specified plicable test system the laboratory
in this section. must do the following:
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, (a) Perform and document calibra-
2003] tion procedures—
(1) Following the manufacturer’s test
§ 493.1254 Standard: Maintenance and system instructions, using calibration
function checks. materials provided or specified, and
(a) Unmodified manufacturer’s equip- with at least the frequency rec-
ment, instruments, or test systems. The ommended by the manufacturer;
laboratory must perform and document (2) Using the criteria verified or es-
the following: tablished by the laboratory as specified
(1) Maintenance as defined by the in § 493.1253(b)(3)—
manufacturer and with at least the fre- (i) Using calibration materials appro-
quency specified by the manufacturer. priate for the test system and, if pos-
(2) Function checks as defined by the sible, traceable to a reference method
manufacturer and with at least the fre- or reference material of known value;
quency specified by the manufacturer. and
Function checks must be within the (ii) Including the number, type, and
manufacturer’s established limits be- concentration of calibration materials,
fore patient testing is conducted. as well as acceptable limits for and the
(b) Equipment, instruments, or test sys- frequency of calibration; and
tems developed in-house, commercially (3) Whenever calibration verification
available and modified by the laboratory, fails to meet the laboratory’s accept-
or maintenance and function check proto- able limits for calibration verification.
cols are not provided by the manufac- (b) Perform and document calibra-
turer. The laboratory must do the fol- tion verification procedures—
lowing: (1) Following the manufacturer’s
(1)(i) Establish a maintenance pro- calibration verification instructions;
tocol that ensures equipment, instru- (2) Using the criteria verified or es-
ment, and test system performance tablished by the laboratory under
that is necessary for accurate and reli- § 493.1253(b)(3)—
able test results and test result report- (i) Including the number, type, and
ing. concentration of the materials, as well
(ii) Perform and document the main- as acceptable limits for calibration
tenance activities specified in para- verification; and
graph (b)(1)(i) of this section. (ii) Including at least a minimal (or

(2)(i) Define a function check pro- zero) value, a mid-point value, and a
tocol that ensures equipment, instru- maximum value near the upper limit of
684
the range to verify the laboratory’s re- (1) Perform control procedures as de-
portable range of test results for the fined in this section unless otherwise
test system; and specified in the additional specialty
(3) At least once every 6 months and and subspecialty requirements at
whenever any of the following occur: §§ 493.1261 through 493.1278.
(i) A complete change of reagents for (2) For each test system, perform
a procedure is introduced, unless the control procedures using the number
laboratory can demonstrate that and frequency specified by the manu-
changing reagent lot numbers does not facturer or established by the labora-
affect the range used to report patient tory when they meet or exceed the re-
test results, and control values are not quirements in paragraph (d)(3) of this
adversely affected by reagent lot num- section.
ber changes. (3) At least once each day patient
(ii) There is major preventive main- specimens are assayed or examined
tenance or replacement of critical perform the following for—
parts that may influence test perform- (i) Each quantitative procedure, in-
ance. clude two control materials of different
(iii) Control materials reflect an un- concentrations;
usual trend or shift, or are outside of (ii) Each qualitative procedure, in-
the laboratory’s acceptable limits, and clude a negative and positive control
other means of assessing and cor- material;
recting unacceptable control values (iii) Test procedures producing grad-
fail to identify and correct the prob- ed or titered results, include a negative
lem. control material and a control mate-
(iv) The laboratory’s established rial with graded or titered reactivity,
schedule for verifying the reportable respectively;
range for patient test results requires (iv) Each test system that has an ex-
more frequent calibration verification. traction phase, include two control ma-
terials, including one that is capable of
§ 493.1256 Standard: Control proce- detecting errors in the extraction proc-
dures. ess; and
(a) For each test system, the labora- (v) Each molecular amplification pro-
tory is responsible for having control cedure, include two control materials
procedures that monitor the accuracy and, if reaction inhibition is a signifi-
and precision of the complete analytic cant source of false negative results, a
process. control material capable of detecting
(b) The laboratory must establish the the inhibition.
number, type, and frequency of testing (4) For thin layer chromatography—
control materials using, if applicable, (i) Spot each plate or card, as appli-
the performance specifications verified cable, with a calibrator containing all
or established by the laboratory as known substances or drug groups, as
specified in § 493.1253(b)(3). appropriate, which are identified by
(c) The control procedures must— thin layer chromatography and re-
(1) Detect immediate errors that ported by the laboratory; and
occur due to test system failure, ad- (ii) Include at least one control mate-
verse environmental conditions, and rial on each plate or card, as applica-
operator performance. ble, which must be processed through
(2) Monitor over time the accuracy each step of patient testing, including
and precision of test performance that extraction processes.
may be influenced by changes in test (5) For each electrophoretic proce-
system performance and environ- dure include, concurrent with patient
mental conditions, and variance in op- specimens, at least one control mate-
erator performance. rial containing the substances being
(d) Unless CMS approves a procedure, identified or measured.
specified in Appendix C of the State (6) Perform control material testing
Operations Manual (CMS Pub. 7), that as specified in this paragraph before re-
provides equivalent quality testing, the suming patient testing when a com-
laboratory must— plete change of reagents is introduced;
685
§ 493.1261 42 CFR Ch. IV (10–1–17 Edition)
major preventive maintenance is per- (4) Before, or concurrent with the ini-
formed; or any critical part that may tial use—
influence test performance is replaced. (i) Check each batch of media for ste-
(7) Over time, rotate control material rility if sterility is required for testing;
testing among all operators who per- (ii) Check each batch of media for its
form the test. ability to support growth and, as ap-
(8) Test control materials in the propriate, select or inhibit specific or-
same manner as patient specimens. ganisms or produce a biochemical re-
(9) When using calibration material sponse; and
as a control material, use calibration (iii) Document the physical charac-
material from a different lot number teristics of the media when com-
than that used to establish a cut-off promised and report any deterioration
value or to calibrate the test system. in the media to the manufacturer.
(10) Establish or verify the criteria (5) Follow the manufacturer’s speci-
for acceptability of all control mate- fications for using reagents, media, and
rials. supplies and be responsible for results.
(i) When control materials providing (f) Results of control materials must
quantitative results are used, statis- meet the laboratory’s and, as applica-
tical parameters (for example, mean ble, the manufacturer’s test system
and standard deviation) for each batch criteria for acceptability before report-
and lot number of control materials ing patient test results.
must be defined and available. (g) The laboratory must document all
(ii) The laboratory may use the stat- control procedures performed.
ed value of a commercially assayed (h) If control materials are not avail-
control material provided the stated able, the laboratory must have an al-
value is for the methodology and in- ternative mechanism to detect imme-
strumentation employed by the labora- diate errors and monitor test system
tory and is verified by the laboratory. performance over time. The perform-
(iii) Statistical parameters for ance of alternative control procedures
unassayed control materials must be must be documented.
established over time by the laboratory
through concurrent testing of control [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
materials having previously deter- 2003]
mined statistical parameters. § 493.1261 Standard: Bacteriology.
(e) For reagent, media, and supply
checks, the laboratory must do the fol- (a) The laboratory must check the
lowing: following for positive and negative re-
(1) Check each batch (prepared inactivity using control organisms:
house), lot number (commercially pre- (1) Each day of use for beta-
pared) and shipment of reagents, disks, lactamase methods other than
stains, antisera, (except those specifi- Cefinase TM.
cally referenced in § 493.1261(a)(3)) and (2) Each week of use for Gram stains.
identification systems (systems using (3) When each batch (prepared in-
two or more substrates or two or more house), lot number (commercially pre-
reagents, or a combination) when prepared), and shipment of antisera is pre-
pared or opened for positive and nega- pared or opened, and once every 6
tive reactivity, as well as graded reac- months thereafter.
tivity, if applicable. (b) For antimicrobial susceptibility
(2) Each day of use (unless otherwise tests, the laboratory must check each
specified in this subpart), test staining batch of media and each lot number
materials for intended reactivity to en- and shipment of antimicrobial agent(s)
sure predictable staining characteris- before, or concurrent with, initial use,
tics. Control materials for both posi- using approved control organisms.
tive and negative reactivity must be (1) Each day tests are performed, the
included, as appropriate. laboratory must use the appropriate
(3) Check fluorescent and control organism(s) to check the proce-
immunohistochemical stains for posi- dure.

tive and negative reactivity each time (2) The laboratory’s zone sizes or
of use. minimum inhibitory concentration for
686
control organisms must be within es- (c) The laboratory must document all
tablished limits before reporting pa- control procedures performed, as speci-
tient results. fied in this section.
(c) The laboratory must document all
control procedures performed, as speci- § 493.1264 Standard: Parasitology.
fied in this section. (a) The laboratory must have avail-
able a reference collection of slides or
§ 493.1262 Standard: Mycobacteriology.
photographs and, if available, gross
(a) Each day of use, the laboratory specimens for identification of
must check all reagents or test proce- parasites and use these references in
dures used for mycobacteria identifica- the laboratory for appropriate com-
tion with at least one acid-fast orga- parison with diagnostic specimens.
nism that produces a positive reaction
(b) The laboratory must calibrate
and an acid-fast organism that pro-
and use the calibrated ocular microm-
duces a negative reaction.
eter for determining the size of ova and
(b) For antimycobacterial suscepti-
parasites, if size is a critical param-
bility tests, the laboratory must check
each batch of media and each lot num- eter.
ber and shipment of antimycobacterial (c) Each month of use, the laboratory
agent(s) before, or concurrent with, ini- must check permanent stains using a
tial use, using an appropriate control fecal sample control material that will
organism(s). demonstrate staining characteristics.
(1) The laboratory must establish (d) The laboratory must document all
limits for acceptable control results. control procedures performed, as speci-
(2) Each week tests are performed, fied in this section.
the laboratory must use the appro-
priate control organism(s) to check the § 493.1265 Standard: Virology.
procedure. (a) When using cell culture to isolate
(3) The results for the control orga- or identify viruses, the laboratory
nism(s) must be within established lim- must simultaneously incubate a cell
its before reporting patient results. substrate control or uninoculated cells
(c) The laboratory must document all as a negative control material.
control procedures performed, as speci- (b) The laboratory must document all
fied in this section. control procedures performed, as speci-
§ 493.1263 Standard: Mycology. fied in this section.
(a) The laboratory must check each § 493.1267 Standard: Routine chem-
batch (prepared in-house), lot number istry.
(commercially prepared), and shipment For blood gas analyses, the labora-
of lactophenol cotton blue when pre- tory must perform the following:
pared or opened for intended reactivity
(a) Calibrate or verify calibration ac-
with a control organism(s).
cording to the manufacturer’s speci-
(b) For antifungal susceptibility
fications and with at least the fre-
tests, the laboratory must check each
batch of media and each lot number quency recommended by the manufac-
and shipment of antifungal agent(s) be- turer.
fore, or concurrent with, initial use, (b) Test one sample of control mate-
using an appropriate control orga- rial each 8 hours of testing using a
nism(s). combination of control materials that
(1) The laboratory must establish include both low and high values on
limits for acceptable control results. each day of testing.
(2) Each day tests are performed, the (c) Test one sample of control mate-
laboratory must use the appropriate rial each time specimens are tested un-
control organism(s) to check the proce- less automated instrumentation inter-
dure. nally verifies calibration at least every
(3) The results for the control orga- 30 minutes.

nism(s) must be within established lim- (d) Document all control procedures
its before reporting patient results. performed, as specified in this section.
687
§ 493.1269 42 CFR Ch. IV (10–1–17 Edition)
§ 493.1269 Standard: Hematology. uct storage temperature over a 24-hour

(a) For manual cell counts performed period.
using a hemocytometer— (2) Inspections of the alarm system
(1) One control material must be must be documented.
tested each 8 hours of operation; and (d) Retention of samples of transfused
(2) Patient specimens and control blood. According to the laboratory’s es-
materials must be tested in duplicate. tablished procedures, samples of each
(b) For all nonmanual coagulation unit of transfused blood must be re-
test systems, the laboratory must in- tained for further testing in the event
clude two levels of control material of transfusion reactions. The labora-
each 8 hours of operation and each tory must promptly dispose of blood
time a reagent is changed. not retained for further testing that
(c) For manual coagulation tests— has passed its expiration date.
(1) Each individual performing tests (e) Investigation of transfusion reac-
must test two levels of control mate- tions. (1) According to its established
rials before testing patient samples and procedures, the laboratory that per-
each time a reagent is changed; and forms compatibility testing, or issues
(2) Patient specimens and control blood or blood products, must promptly
materials must be tested in duplicate. investigate all transfusion reactions
(d) The laboratory must document all occurring in facilities for which it has
control procedures performed, as speci- investigational responsibility and
fied in this section. make recommendations to the medical
staff regarding improvements in trans-
§ 493.1271 Standard: fusion procedures.
Immunohematology.
(2) The laboratory must document, as
(a) Patient testing. (1) The laboratory applicable, that all necessary remedial
must perform ABO grouping, D(Rho) actions are taken to prevent
typing, unexpected antibody detection, recurrences of transfusion reactions
antibody identification, and compat- and that all policies and procedures are
ibility testing by following the manu- reviewed to assure they are adequate
facturer’s instructions, if provided, and to ensure the safety of individuals
as applicable, 21 CFR 606.151(a) through being transfused.
(e). (f) Documentation. The laboratory
(2) The laboratory must determine must document all control procedures
ABO group by concurrently testing un- performed, as specified in this section.
known red cells with, at a minimum,
anti-A and anti-B grouping reagents. [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
For confirmation of ABO group, the 2003]
unknown serum must be tested with
§ 493.1273 Standard: Histopathology.
known A1 and B red cells.
(3) The laboratory must determine (a) As specified in § 493.1256(e)(3), fluo-
the D(Rho) type by testing unknown rescent and immunohistochemical
red cells with anti-D (anti-Rho) blood stains must be checked for positive and
typing reagent. negative reactivity each time of use.
(b) Immunohematological testing and For all other differential or special
distribution of blood and blood products. stains, a control slide of known reac-
Blood and blood product testing and tivity must be stained with each pa-
distribution must comply with 21 CFR tient slide or group of patient slides.
606.100(b)(12); 606.160(b)(3)(ii) and Reaction(s) of the control slide with
(b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); each special stain must be documented.
and 640.11(b). (b) The laboratory must retain
(c) Blood and blood products storage. stained slides, specimen blocks, and
Blood and blood products must be tissue remnants as specified in
stored under appropriate conditions § 493.1105. The remnants of tissue speci-
that include an adequate temperature mens must be maintained in a manner
alarm system that is regularly in- that ensures proper preservation of the
spected. tissue specimens until the portions

(1) An audible alarm system must submitted for microscopic examination
monitor proper blood and blood prod- have been examined and a diagnosis
688
made by an individual qualified under (1) A review of slides from at least 10

§ 493.1449(b), (l), or (m). percent of the gynecologic cases inter-
(c) An individual who has success- preted by individuals qualified under
fully completed a training program in § 493.1469 or § 493.1483, to be negative for
neuromuscular pathology approved by epithelial cell abnormalities and other
HHS may examine and provide reports malignant neoplasms (as defined in
for neuromuscular pathology. paragraph (e)(1) of this section).
(d) Tissue pathology reports must be (i) The review must be performed by
signed by an individual qualified as an individual who meets one of the fol-
specified in paragraph (b) or, as appro- lowing qualifications:
priate, paragraph (c) of this section. If (A) A technical supervisor qualified
a computer report is generated with an under § 493.1449(b) or (k).
electronic signature, it must be au- (B) A cytology general supervisor
thorized by the individual who per- qualified under § 493.1469.
formed the examination and made the (C) A cytotechnologist qualified
diagnosis. under § 493.1483 who has the experience
(e) The laboratory must use accept- specified in § 493.1469(b)(2).
able terminology of a recognized sys- (ii) Cases must be randomly selected
tem of disease nomenclature in report- from the total caseload and include
ing results. negatives and those from patients or
(f) The laboratory must document all groups of patients that are identified
control procedures performed, as speci- as having a higher than average prob-
fied in this section. ability of developing cervical cancer
based on available patient information.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, (iii) The review of those cases se-
2003]
lected must be completed before re-
§ 493.1274 Standard: Cytology. porting patient results.
(2) Laboratory comparison of clinical
(a) Cytology slide examination site. All information, when available, with cy-
cytology slide preparations must be tology reports and comparison of all
evaluated on the premises of a labora- gynecologic cytology reports with a di-
tory certified to conduct testing in the agnosis of high-grade squamous
subspecialty of cytology. intraepithelial lesion (HSIL), adenocar-
(b) Staining. The laboratory must cinoma, or other malignant neoplasms
have available and follow written poli- with the histopathology report, if
cies and procedures for each of the fol- available in the laboratory (either on-
lowing, if applicable: site or in storage), and determination
(1) All gynecologic slide preparations of the causes of any discrepancies.
must be stained using a Papanicolaou (3) For each patient with a current
or modified Papanicolaou staining HSIL, adenocarcinoma, or other malig-
method. nant neoplasm, laboratory review of all
(2) Effective measures to prevent normal or negative gynecologic speci-
cross-contamination between mens received within the previous 5
gynecologic and nongynecologic speci- years, if available in the laboratory (ei-
mens during the staining process must ther on-site or in storage). If signifi-
be used. cant discrepancies are found that will
(3) Nongynecologic specimens that affect current patient care, the labora-
have a high potential for cross-con- tory must notify the patient’s physi-
tamination must be stained separately cian and issue an amended report.
from other nongynecologic specimens, (4) Records of initial examinations
and the stains must be filtered or and all rescreening results must be
changed following staining. documented.
(c) Control procedures. The laboratory (5) An annual statistical laboratory
must establish and follow written poli- evaluation of the number of—
cies and procedures for a program de- (i) Cytology cases examined;
signed to detect errors in the perform- (ii) Specimens processed by specimen
ance of cytologic examinations and the type;

reporting of results. The program must (iii) Patient cases reported by diag-
include the following: nosis (including the number reported
689
§ 493.1274 42 CFR Ch. IV (10–1–17 Edition)
as unsatisfactory for diagnostic inter- (ii) For the purposes of establishing

pretation); workload limits for individuals exam-
(iv) Gynecologic cases with a diag- ining slides in less than an 8-hour
nosis of HSIL, adenocarcinoma, or workday (includes full-time employees
other malignant neoplasm for which with duties other than slide examina-
histology results were available for tion and part-time employees), a period
comparison; of 8 hours is used to prorate the num-
(v) Gynecologic cases where cytology ber of slides that may be examined.
and histology are discrepant; and The formula—
(vi) Gynecologic cases where any re-
screen of a normal or negative speci- Number of hours examining slides × 100
men results in reclassification as low- 8
grade squamous intraepithelial lesion
(LSIL), HSIL, adenocarcinoma, or is used to determine maximum slide
other malignant neoplasms. volume to be examined;
(6) An evaluation of the case reviews (iii) Nongynecologic slide prepara-
of each individual examining slides tions made using liquid-based slide pre-
against the laboratory’s overall statis- paratory techniques that result in cell
tical values, documentation of any dis- dispersion over one-half or less of the
crepancies, including reasons for the total available slide may be counted as
deviation and, if appropriate, correc- one-half slide; and
tive actions taken. (iv) Technical supervisors who per-
form primary screening are not re-
(d) Workload limits. The laboratory
quired to include tissue pathology
must establish and follow written poli-
slides and previously examined cytol-
cies and procedures that ensure the fol-
ogy slides (gynecologic and
lowing:
nongynecologic) in the 100 slide work-
(1) The technical supervisor estab- load limit.
lishes a maximum workload limit for (3) The laboratory must maintain
each individual who performs primary records of the total number of slides
screening. examined by each individual during
(i) The workload limit is based on the each 24-hour period and the number of
individual’s performance using evalua- hours spent examining slides in the 24-
tions of the following: hour period irrespective of the site or
(A) Review of 10 percent of the cases laboratory.
interpreted as negative for the condi- (4) Records are available to document
tions defined in paragraph (e)(1) of this the workload limit for each individual.
section. (e) Slide examination and reporting.
(B) Comparison of the individual’s in- The laboratory must establish and fol-
terpretation with the technical super- low written policies and procedures
visor’s confirmation of patient smears that ensure the following:
specified in paragraphs (e)(1) and (e)(3) (1) A technical supervisor confirms
of this section. each gynecologic slide preparation in-
(ii) Each individual’s workload limit terpreted to exhibit reactive or repar-
is reassessed at least every 6 months ative changes or any of the following
and adjusted when necessary. epithelial cell abnormalities:
(2) The maximum number of slides (i) Squamous cell.
examined by an individual in each 24- (A) Atypical squamous cells of unde-
hour period does not exceed 100 slides termined significance (ASC-US) or can-
(one patient specimen per slide; not exclude HSIL (ASC-H).
gynecologic, nongynecologic, or both) (B) LSIL-Human papillomavirus
irrespective of the site or laboratory. (HPV)/mild dysplasia/cervical
This limit represents an absolute max- intraepithelial neoplasia 1 (CIN 1).
imum number of slides and must not be (C) HSIL-moderate and severe dys-
employed as an individual’s perform- plasia, carcinoma in situ (CIS)/CIN 2
ance target. In addition— and CIN 3 or with features suspicious
(i) The maximum number of 100 slides for invasion.

is examined in no less than an 8-hour (D) Squamous cell carcinoma.
workday; (ii) Glandular cell.
690
ER24JA03.000</GPH>
(A) Atypical cells not otherwise spec- automated screening devices, the lab-
ified (NOS) or specified in comments oratory must follow manufacturer’s in-
(endocervical, endometrial, or glan- structions for preanalytic, analytic,
dular). and postanalytic phases of testing, as
(B) Atypical cells favor neoplastic applicable, and meet the applicable re-
(endocervical or glandular). quirements of this subpart K.
(C) Endocervical adenocarcinoma in (h) Documentation. The laboratory
situ. must document all control procedures
(D) Adenocarcinoma endocervical, performed, as specified in this section.
adenocarcinoma endometrial, adeno-
carcinoma extrauterine, and adenocar- [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
2003]
cinoma NOS.
(iii) Other malignant neoplasms.
§ 493.1276 Standard: Clinical cyto-
(2) The report of gynecologic slide genetics.
preparations with conditions specified
in paragraph (e)(1) of this section must (a) The laboratory must have policies
be signed to reflect the technical su- and procedures for ensuring accurate
pervisory review or, if a computer re- and reliable patient specimen identi-
port is generated with signature, it fication during the process of
must reflect an electronic signature accessioning, cell preparation,
authorized by the technical supervisor photographing or other image repro-
who performed the review. duction technique, photographic print-
(3) All nongynecologic preparations ing, and reporting and storage of re-
are reviewed by a technical supervisor. sults, karyotypes, and photographs.
The report must be signed to reflect (b) The laboratory must have records
technical supervisory review or, if a that document the following:
computer report is generated with sig- (1) The media used, reactions ob-
nature, it must reflect an electronic served, number of cells counted, num-
signature authorized by the technical ber of cells karyotyped, number of
supervisor who performed the review. chromosomes counted for each meta-
(4) Unsatisfactory specimens or slide phase spread, and the quality of the
preparations are identified and re- banding.
ported as unsatisfactory. (2) The resolution is appropriate for
(5) The report contains narrative de- the type of tissue or specimen and the
scriptive nomenclature for all results. type of study required based on the
(6) Corrected reports issued by the clinical information provided to the
laboratory indicate the basis for cor- laboratory.
rection. (3) An adequate number of
(f) Record and slide retention. (1) The karyotypes are prepared for each pa-
laboratory must retain all records and tient.
slide preparations as specified in (c) Determination of sex must be per-
§ 493.1105. formed by full chromosome analysis.
(2) Slides may be loaned to pro- (d) The laboratory report must in-
ficiency testing programs in lieu of clude a summary and interpretation of
maintaining them for the required the observations, number of cells
time period, provided the laboratory counted and analyzed, and use the
receives written acknowledgment of International System for Human Cyto-
the receipt of slides by the proficiency genetic Nomenclature.
testing program and maintains the ac- (e) The laboratory must document all
knowledgment to document the loan of control procedures performed, as speci-
these slides. fied in this section.
(3) Documentation of slides loaned or
referred for purposes other than pro- [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
ficiency testing must be maintained. 2003]
(4) All slides must be retrievable
upon request. § 493.1278 Standard:
(g) Automated and semi-automated Histocompatibility.

screening devices. When performing (a) General. The laboratory must
evaluations using automated and semi- meet the following requirements:
691
§ 493.1278 42 CFR Ch. IV (10–1–17 Edition)
(1) An audible alarm system must be W.H.O. Committee on Nomenclature

used to monitor the storage tempera- and for which reagents are readily
ture of specimens (donor and bene- available.
ficiary) and reagents. The laboratory (iv) The assignment of HLA antigens.
must have an emergency plan for alter- (v) When antigen redefinition and re-
nate storage. typing are required.
(2) All patient specimens must be (6) Check each HLA typing by test-
easily retrievable. ing, at a minimum the following:
(3) Reagent typing sera inventory (i) A positive control material.
prepared in-house must indicate (ii) A negative control material in
source, bleeding date and identification which, if applicable to the technique
number, reagent specificity, and vol- performed, cell viability at the end of
ume remaining. incubation is sufficient to permit accu-
(4) If the laboratory uses rate interpretation of results. In assays
immunologic reagents (for example, in which cell viability is not required,
antibodies, antibody-coated particles, the negative control result must be
or complement) to facilitate or en- sufficiently different from the positive
hance the isolation of lymphocytes, or control result to permit accurate inter-
lymphocyte subsets, the efficacy of the pretation of results.
methods must be monitored with ap- (iii) Positive control materials for
propriate quality control procedures. specific cell types when applicable
(5) Participate in at least one na- (that is, T cells, B cells, and mono-
tional or regional cell exchange pro- cytes).
gram, if available, or develop an ex- (c) Disease-associated studies. The lab-
change system with another laboratory oratory must check each typing for
in order to validate interlaboratory re- disease-associated HLA antigens using
producibility. control materials to monitor the test
(b) HLA typing. The laboratory must components and each phase of the test
do the following: system to ensure acceptable perform-
(1) Use a technique(s) that is estab- ance.
lished to optimally define, as applica- (d) Antibody Screening. The labora-
ble, HLA Class I and II specificities. tory must do the following:
(2) HLA type all potential transplant (1) Use a technique(s) that detects
beneficiaries at a level appropriate to HLA-specific antibody with a speci-
support clinical transplant protocol ficity equivalent or superior to that of
and donor selection. the basic complement-dependent
(3) HLA type cells from organ donors microlymphocytotoxicity assay.
referred to the laboratory. (2) Use a method that distinguishes
(4) Use HLA antigen terminology antibodies to HLA Class II antigens
that conforms to the latest report of from antibodies to Class I antigens to
the World Health Organization detect antibodies to HLA Class II anti-
(W.H.O.) Committee on Nomenclature. gens.
Potential new antigens not yet ap- (3) Use a panel that contains all the
proved by this committee must have a major HLA specificities and common
designation that cannot be confused splits. If the laboratory does not use
with W.H.O. terminology. commercial panels, it must maintain a
(5) Have available and follow written list of individuals for fresh panel bleed-
criteria for the following: ing.
(i) The preparation of cells or cel- (4) Make a reasonable attempt to
lular extracts (for example, solubilized have available monthly serum speci-
antigens and nucleic acids), as applica- mens for all potential transplant bene-
ble to the HLA typing technique(s) per- ficiaries for periodic antibody screen-
formed. ing and crossmatch.
(ii) Selecting typing reagents, wheth- (5) Have available and follow a writ-
er prepared in-house or commercially. ten policy consistent with clinical
(iii) Ensuring that reagents used for transplant protocols for the frequency
typing are adequate to define all HLA- of screening potential transplant bene-
A, B and DR specificities that are offi- ficiary sera for preformed HLA-specific
cially recognized by the most recent antibodies.
692
(6) Check each antibody screening by (3) For nonrenal transplantation, if

testing, at a minimum the following: HLA testing and final crossmatches
(i) A positive control material con- were not performed prospectively be-
taining antibodies of the appropriate cause of an emergency situation, the
isotype for the assay. laboratory must document the cir-
(ii) A negative control material. cumstances, if known, under which the
(7) As applicable, have available and emergency transplant was performed,
follow written criteria and procedures and records of the transplant must re-
for antibody identification to the level flect any information provided to the
appropriate to support clinical trans- laboratory by the patient’s physician.
plant protocol. (g) Documentation. The laboratory
(e) Crossmatching. The laboratory must document all control procedures
must do the following: performed, as specified in this section.
(1) Use a technique(s) documented to [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
have increased sensitivity in compari- 2003]
son with the basic complement-depend-
ent microlymphocytotoxicity assay. § 493.1281 Standard: Comparison of
(2) Have available and follow written test results.
criteria for the following: (a) If a laboratory performs the same
(i) Selecting appropriate patient test using different methodologies or
serum samples for crossmatching. instruments, or performs the same test
(ii) The preparation of donor cells or at multiple testing sites, the labora-
cellular extracts (for example, solu- tory must have a system that twice a
bilized antigens and nucleic acids), as year evaluates and defines the relation-
applicable to the crossmatch tech- ship between test results using the dif-
nique(s) performed. ferent methodologies, instruments, or
(3) Check each crossmatch and com- testing sites.
patibility test for HLA Class II anti- (b) The laboratory must have a sys-
genic differences using control mate- tem to identify and assess patient test
rials to monitor the test components results that appear inconsistent with
and each phase of the test system to the following relevant criteria, when
ensure acceptable performance. available:
(f) Transplantation. Laboratories per- (1) Patient age.
forming histocompatibility testing for (2) Sex.
transfusion and transplantation pur- (3) Diagnosis or pertinent clinical
poses must do the following: data.
(1) Have available and follow written (4) Distribution of patient test re-
policies and protocols specifying the sults.
histocompatibility testing (that is, (5) Relationship with other test pa-
HLA typing, antibody screening, com- rameters.
patibility testing and crossmatching) (c) The laboratory must document all
to be performed for each type of cell, test result comparison activities.
tissue or organ to be transfused or
transplanted. The laboratory’s policies § 493.1282 Standard: Corrective ac-
must include, as applicable— tions.
(i) Testing protocols for cadaver (a) Corrective action policies and
donor, living, living-related, and com- procedures must be available and fol-
bined organ and tissue transplants; lowed as necessary to maintain the lab-
(ii) Testing protocols for patients at oratory’s operation for testing patient
high risk for allograft rejection; and specimens in a manner that ensures ac-
(iii) The level of testing required to curate and reliable patient test results
support clinical transplant protocols and reports.
(for example, antigen or allele level). (b) The laboratory must document all
(2) For renal allotransplantation and corrective actions taken, including ac-
combined organ and tissue transplants tions taken when any of the following
in which a kidney is to be trans- occur:
planted, have available results of final (1) Test systems do not meet the lab-
crossmatches before the kidney is oratory’s verified or established per-
transplanted. formance specifications, as determined
693
§ 493.1283 42 CFR Ch. IV (10–1–17 Edition)
in § 493.1253(b), which include but are lytic systems specified in §§ 493.1251

not limited to— through 493.1283.
(i) Equipment or methodologies that (b) The analytic systems quality as-
perform outside of established oper- sessment must include a review of the
ating parameters or performance speci- effectiveness of corrective actions
fications; taken to resolve problems, revision of
(ii) Patient test values that are out- policies and procedures necessary to
side of the laboratory’s reportable prevent recurrence of problems, and
range of test results for the test sys- discussion of analytic systems quality
tem; and assessment reviews with appropriate
(iii) When the laboratory determines staff.
that the reference intervals (normal (c) The laboratory must document all
values) for a test procedure are inap- analytic systems quality assessment
propriate for the laboratory’s patient activities.
population. [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
(2) Results of control or calibration 2003]
materials, or both, fail to meet the lab-
oratory’s established criteria for ac- POSTANALYTIC SYSTEMS
ceptability. All patient test results ob-
tained in the unacceptable test run and § 493.1290 Condition: Postanalytic sys-
since the last acceptable test run must tems.
be evaluated to determine if patient Each laboratory that performs non-
test results have been adversely af- waived testing must meet the applica-
fected. The laboratory must take the ble postanalytic systems requirements
corrective action necessary to ensure in § 493.1291 unless HHS approves a pro-
the reporting of accurate and reliable cedure, specified in Appendix C of the
patient test results. State Operations Manual (CMS Pub. 7)
(3) The criteria for proper storage of that provides equivalent quality test-
reagents and specimens, as specified ing. The laboratory must monitor and
under § 493.1252(b), are not met. evaluate the overall quality of the
postanalytic systems and correct iden-
§ 493.1283 Standard: Test records. tified problems as specified in § 493.1299
(a) The laboratory must maintain an for each specialty and subspecialty of
information or record system that in- testing performed.
cludes the following:
(1) The positive identification of the § 493.1291 Standard: Test report.
specimen. (a) The laboratory must have an ade-
(2) The date and time of specimen re- quate manual or electronic system(s)
ceipt into the laboratory. in place to ensure test results and
(3) The condition and disposition of other patient-specific data are accu-
specimens that do not meet the labora- rately and reliably sent from the point
tory’s criteria for specimen accept- of data entry (whether interfaced or
ability. entered manually) to final report des-
(4) The records and dates of all speci- tination, in a timely manner. This in-
men testing, including the identity of cludes the following:
the personnel who performed the (1) Results reported from calculated
test(s). data.
(b) Records of patient testing includ- (2) Results and patient-specific data
ing, if applicable, instrument print- electronically reported to network or
outs, must be retained. interfaced systems.
(3) Manually transcribed or electroni-
§ 493.1289 Standard: Analytic systems cally transmitted results and patient-
quality assessment. specific information reported directly
(a) The laboratory must establish or upon receipt from outside referral
and follow written policies and proce- laboratories, satellite or point-of-care
dures for an ongoing mechanism to testing locations.

monitor, assess, and when indicated, (b) Test report information main-
correct problems identified in the ana- tained as part of the patient’s chart or
694
medical record must be readily avail- (h) When the laboratory cannot re-
able to the laboratory and to CMS or a port patient test results within its es-
CMS agent upon request. tablished time frames, the laboratory
(c) The test report must indicate the must determine, based on the urgency
following: of the patient test(s) requested, the
(1) For positive patient identifica- need to notify the appropriate indi-
tion, either the patient’s name and vidual(s) of the delayed testing.
identification number, or a unique pa- (i) If a laboratory refers patient
tient identifier and identification num- specimens for testing—
ber. (1) The referring laboratory must not
(2) The name and address of the lab- revise results or information directly
oratory location where the test was related to the interpretation of results
performed. provided by the testing laboratory;
(3) The test report date. (2) The referring laboratory may per-
(4) The test performed. mit each testing laboratory to send the
(5) Specimen source, when appro- test result directly to the authorized
priate. person who initially requested the test.
(6) The test result and, if applicable, The referring laboratory must retain
the units of measurement or interpre- or be able to produce an exact dupli-
tation, or both. cate of each testing laboratory’s re-
(7) Any information regarding the port; and
condition and disposition of specimens (3) The authorized person who orders
that do not meet the laboratory’s cri- a test must be notified by the referring
teria for acceptability. laboratory of the name and address of
(d) Pertinent ‘‘reference intervals’’ or each laboratory location where the test
‘‘normal’’ values, as determined by the was performed.
laboratory performing the tests, must (j) All test reports or records of the
be available to the authorized person information on the test reports must
who ordered the tests and, if applica- be maintained by the laboratory in a
ble, the individual responsible for using manner that permits ready identifica-
the test results. tion and timely accessibility.
(e) The laboratory must, upon re- (k) When errors in the reported pa-
quest, make available to clients a list tient test results are detected, the lab-
of test methods employed by the laboratory must do the following:
oratory and, as applicable, the per- (1) Promptly notify the authorized
formance specifications established or person ordering the test and, if applica-
verified as specified in § 493.1253. In ad- ble, the individual using the test re-
dition, information that may affect the sults of reporting errors.
interpretation of test results, for exam- (2) Issue corrected reports promptly
ple test interferences, must be provided to the authorized person ordering the
upon request. Pertinent updates on test and, if applicable, the individual
testing information must be provided using the test results.
to clients whenever changes occur that
(3) Maintain duplicates of the origi-
affect the test results or interpretation
nal report, as well as the corrected re-
of test results.
port.
(f) Except as provided in § 493.1291(l),
(l) Upon request by a patient (or the
test results must be released only to
authorized persons and, if applicable, patient’s personal representative), the
the persons responsible for using the laboratory may provide patients, their
test results and the laboratory that personal representatives, and those
initially requested the test. persons specified under 45 CFR
164.524(c)(3)(ii), as applicable, with ac-
(g) The laboratory must immediately
cess to completed test reports that,
alert the individual or entity request-
using the laboratory’s authentication
ing the test and, if applicable, the indi-
vidual responsible for using the test re- process, can be identified as belonging
sults when any test result indicates an to that patient.

imminently life-threatening condition, [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
or panic or alert values. 2003, as amended at 79 FR 7316, Feb. 6, 2014]
695
§ 493.1299 42 CFR Ch. IV (10–1–17 Edition)
§ 493.1299 Standard: Postanalytic sys- § 493.1355 Condition: Laboratories per-

tems quality assessment. forming PPM procedures; labora-
(a) The laboratory must establish tory director.
and follow written policies and proce- The laboratory must have a director
dures for an ongoing mechanism to who meets the qualification require-
monitor, assess and, when indicated, ments of § 493.1357 and provides overall
correct problems identified in the management and direction in accord-
postanalytic systems specified in ance with § 493.1359.
§ 493.1291.
(b) The postanalytic systems quality § 493.1357 Standard; laboratory direc-
assessment must include a review of tor qualifications.
the effectiveness of corrective actions
taken to resolve problems, revision of The laboratory director must be
policies and procedures necessary to qualified to manage and direct the lab-
prevent recurrence of problems, and oratory personnel and the performance
discussion of postanalytic systems of PPM procedures as specified in
quality assessment reviews with appro- § 493.19(c) and must be eligible to be an
priate staff. operator of a laboratory within the re-
(c) The laboratory must document all quirements of subpart R of this part.
postanalytic systems quality assess- (a) The laboratory director must pos-
ment activities. sess a current license as a laboratory
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, director issued by the State in which
2003] the laboratory is located, if the licens-
ing is required.
Subpart L [Reserved] (b) The laboratory director must
meet one of the following require-
Subpart M—Personnel for ments:
Nonwaived Testing (1) Be a physician, as defined in
§ 493.2.
SOURCE: 57 FR 7172, Feb. 28, 1992, unless (2) Be a midlevel practitioner, as de-
otherwise noted. fined in § 493.2, authorized by a State to
practice independently in the State in
§ 493.1351 General. which the laboratory is located.
This subpart consists of the per- (3) Be a dentist, as defined in § 493.2.
sonnel requirements that must be met
by laboratories performing moderate § 493.1359 Standard; PPM laboratory
complexity testing, PPM procedures, director responsibilities.
high complexity testing, or any com- The laboratory director is respon-
bination of these tests. sible for the overall operation and ad-
[60 FR 20049, Apr. 24, 1995] ministration of the laboratory, includ-
ing the prompt, accurate, and pro-
LABORATORIES PERFORMING PROVIDER- ficient reporting of test results. The
PERFORMED MICROSCOPY (PPM) PRO- laboratory director must—
CEDURES
(a) Direct no more than five labora-
tories; and
SOURCE: 60 FR 20049, Apr. 24, 1995, unless
otherwise noted. (b) Ensure that any procedure listed
under § 493.19(c)—
§ 493.1353 Scope. (1) Is personally performed by an in-
In accordance with § 493.19(b), the dividual who meets the qualification
moderate complexity procedures speci- requirements in § 493.1363; and
fied as PPM procedures are considered (2) Is performed in accordance with
such only when personally performed applicable requirements in subparts H,
by a health care provider during a pa- J, K, and M of this part.
tient visit in the context of a physical

examination. PPM procedures are sub-
FR 3713, Jan. 24, 2003; 68 FR 50724, Aug. 22,
ject to the personnel requirements in 2003]
§§ 493.1355 through 493.1365.
696
§ 493.1361 Condition: Laboratories per- (b) Performed using a microscope

forming PPM procedures; testing limited to a brightfield or a phase/con-
personnel. trast microscope.
The laboratory must have a suffi-
LABORATORIES PERFORMING MODERATE
cient number of individuals who meet
COMPLEXITY TESTING
the qualification requirements of
§ 493.1363 to perform the functions spec- § 493.1403 Condition: Laboratories per-
ified in § 493.1365 for the volume and forming moderate complexity test-
complexity of testing performed. ing; laboratory director.
§ 493.1363 Standard: PPM testing per- The laboratory must have a director
sonnel qualifications. who meets the qualification require-
ments of § 493.1405 of this subpart and
Each individual performing PPM pro- provides overall management and di-
cedures must— rection in accordance with § 493.1407 of
(a) Possess a current license issued this subpart.
by the State in which the laboratory is
located if the licensing is required; and § 493.1405 Standard; Laboratory direc-
(b) Meet one of the following require- tor qualifications.
ments: The laboratory director must be
(1) Be a physician, as defined in qualified to manage and direct the lab-
§ 493.2. oratory personnel and the performance
(2) Be a midlevel practitioner, as de- of moderate complexity tests and must
fined in § 493.2, under the supervision of be eligible to be an operator of a lab-
a physician or in independent practice oratory within the requirements of
if authorized by the State in which the subpart R of this part.
laboratory is located. (a) The laboratory director must pos-
(3) Be a dentist as defined in § 493.2 of sess a current license as a laboratory
this part. director issued by the State in which
the laboratory is located, if such li-
§ 493.1365 Standard; PPM testing per-
sonnel responsibilities. censing is required; and
(b) The laboratory director must—
The testing personnel are responsible (1) (i) Be a doctor of medicine or doc-
for specimen processing, test perform- tor of osteopathy licensed to practice
ance, and for reporting test results. medicine or osteopathy in the State in
Any PPM procedure must be— which the laboratory is located; and
(a) Personally performed by one of (ii) Be certified in anatomic or clin-
the following practitioners: ical pathology, or both, by the Amer-
(1) A physician during the patient’s ican Board of Pathology or the Amer-
visit on a specimen obtained from his ican Osteopathic Board of Pathology or
or her own patient or from a patient of possess qualifications that are equiva-
a group medical practice of which the lent to those required for such certifi-
physician is a member or employee. cation; or
(2) A midlevel practitioner, under the (2)(i) Be a doctor of medicine, doctor
supervision of a physician or in inde- of osteopathy, or doctor of podiatric
pendent practice if authorized by the medicine licensed to practice medicine,
State in which the laboratory is lo- osteopathy, or podiatry in the State in
cated, during the patient’s visit on a which the laboratory is located; and
specimen obtained from his or her own (ii) Have had laboratory training or
patient or from the patient of a clinic, experience consisting of:
group medical practice, or other health (A) At least one year directing or su-
care provider, in which the midlevel pervising non-waived laboratory test-
practitioner is a member or an em- ing; or
ployee. (B) Beginning September 1, 1993, have
(3) A dentist during the patient’s at least 20 continuing medical edu-
visit on a specimen obtained from his cation credit hours in laboratory prac-
or her own patient or from a patient of tice commensurate with the director
a group dental practice of which the responsibilities defined in § 493.1407; or

dentist is a member or an employee; (C) Laboratory training equivalent to
and paragraph (b)(2)(ii)(B) of this section
697
§ 493.1406 42 CFR Ch. IV (10–1–17 Edition)
obtained during medical residency. director issued by the State, if such li-
(For example, physicians certified ei- censing exists; and
ther in hematology or hematology and (b) The laboratory director must:
medical oncology by the American (1) Be a physician certified in ana-
Board of Internal Medicine); or tomical or clinical pathology (or both)
(3) Hold an earned doctoral degree in by the American Board of Pathology or
a chemical, physical, biological, or the American Osteopathic Board of Pa-
clinical laboratory science from an ac- thology or possess qualifications that
credited institution; and are equivalent to those required for
(i) Be certified by the American such certification;
Board of Medical Microbiology, the (2) Be a physician who:
American Board of Clinical Chemistry, (i) Is certified by the American Board
the American Board of Bioanalysis, or of Pathology or the American Osteo-
the American Board of Medical Labora- pathic Board of Pathology in at least
tory Immunology; or one of the laboratory specialties; or
(ii) Have had at least one year experi- (ii) Is certified by the American
ence directing or supervising non- Board of Medical Microbiology, the
waived laboratory testing; American Board of Clinical Chemistry,
(4)(i) Have earned a master’s degree the American Board of Bioanalysis, or
in a chemical, physical, biological or other national accrediting board in one
clinical laboratory science or medical of the laboratory specialties; or
technology from an accredited institu- (iii) Is certified by the American So-
tion; ciety of Cytology to practice
(ii) Have at least one year of labora- cytopathology or possesses qualifica-
tory training or experience, or both in tions that are equivalent to those re-
non-waived testing; and quired for such certification; or
(iii) In addition, have at least one (iv) Subsequent to graduation, has
year of supervisory laboratory experi- had 4 or more years of full-time general
ence in non-waived testing; or laboratory training and experience of
(5)(i) Have earned a bachelor’s degree which at least 2 years were spent ac-
in a chemical, physical, or biological quiring proficiency in one of the lab-
science or medical technology from an oratory specialties;
accredited institution; (3) For the subspecialty of oral pa-
(ii) Have at least 2 years of labora- thology only, be certified by the Amer-
tory training or experience, or both in ican Board of Oral Pathology, Amer-
non-waived testing; and ican Board of Pathology or the Amer-
(iii) In addition, have at least 2 years ican Osteopathic Board of Pathology or
of supervisory laboratory experience in possesses qualifications that are equiv-
non-waived testing; alent to those required for certifi-
(6) Be serving as a laboratory direc- cation;
tor and must have previously qualified (4) Hold an earned doctoral degree
or could have qualified as a laboratory from an accredited institution with a
director under § 493.1406; or chemical, physical, or biological
(7) On or before February 28, 1992, science as a major subject and
qualified under State law to direct a (i) Is certified by the American Board
laboratory in the State in which the of Medical Microbiology, the American
laboratory is located. Board of Clinical Chemistry, the Amer-
[57 FR 7172, Feb. 28, 1992, as amended at 58 ican Board of Bioanalysis, or other na-
FR 5233, Jan. 19, 1993] tional accrediting board acceptable to
HHS in one of the laboratory special-
§ 493.1406 Standard; Laboratory direc- ties; or
tor qualifications on or before Feb- (ii) Subsequent to graduation, has
ruary 28, 1992. had 4 or more years of full-time general
The laboratory director must be laboratory training and experience of
qualified to manage and direct the lab- which at least 2 years were spent ac-
oratory personnel and test perform- quiring proficiency in one of the lab-
ance. oratory specialties;

(a) The laboratory director must pos- (5) With respect to individuals first
sess a current license as a laboratory qualifying before July 1, 1971, have
698
been responsible for the direction of a meeting the qualifications of §§ 493.1409,

laboratory for 12 months between July 493.1415, and 493.1421, respectively.
1, 1961, and January 1, 1968, and, in ad- (b) If the laboratory director reappor-
dition, either: tions performance of his or her respon-
(i) Was a physician and subsequent to sibilities, he or she remains responsible
graduation had at least 4 years of per- for ensuring that all duties are prop-
tinent full-time laboratory experience; erly performed.
(ii) Held a master’s degree from an (c) The laboratory director must be
accredited institution with a chemical, accessible to the laboratory to provide
physical, or biological science as a onsite, telephone or electronic con-
major subject and subsequent to grad- sultation as needed.
uation had at least 4 years of pertinent (d) Each individual may direct no
full-time laboratory experience; more than five laboratories.
(iii) Held a bachelor’s degree from an (e) The laboratory director must—
accredited institution with a chemical, (1) Ensure that testing systems de-
physical, or biological science as a veloped and used for each of the tests
major subject and subsequent to grad- performed in the laboratory provide
uation had at least 6 years of pertinent quality laboratory services for all as-
full-time laboratory experience; or pects of test performance, which in-
(iv) Achieved a satisfactory grade cludes the preanalytic, analytic, and
through an examination conducted by postanalytic phases of testing;
or under the sponsorship of the U.S. (2) Ensure that the physical plant
Public Health Service on or before July and environmental conditions of the
1, 1970; or laboratory are appropriate for the test-
(6) Qualify under State law to direct ing performed and provide a safe envi-
the laboratory in the State in which ronment in which employees are pro-
the laboratory is located. tected from physical, chemical, and bi-
NOTE: The January 1, 1968 date for meeting
ological hazards;
the 12 months’ laboratory direction require- (3) Ensure that—
ment in paragraph (b)(5) of this section may (i) The test methodologies selected
be extended 1 year for each year of full-time have the capability of providing the
laboratory experience obtained before Janu- quality of results required for patient
ary 1, 1958 required by State law for a labora- care;
tory director license. An exception to the
(ii) Verification procedures used are
July 1, 1971 qualifying date in paragraph
(b)(5) of this section was made provided that adequate to determine the accuracy,
the individual requested qualification ap- precision, and other pertinent perform-
proval by October 21, 1975 and had been em- ance characteristics of the method; and
ployed in a laboratory for at least 3 years of (iii) Laboratory personnel are per-
the 5 years preceding the date of submission forming the test methods as required
of his qualifications. for accurate and reliable results;
[58 FR 5233, Jan. 19, 1993] (4) Ensure that the laboratory is en-
rolled in an HHS approved proficiency
§ 493.1407 Standard; Laboratory direc- testing program for the testing per-
tor responsibilities. formed and that—
The laboratory director is respon- (i) The proficiency testing samples
sible for the overall operation and ad- are tested as required under subpart H
ministration of the laboratory, includ- of this part;
ing the employment of personnel who (ii) The results are returned within
are competent to perform test proce- the timeframes established by the pro-
dures, and record and report test re- ficiency testing program;
sults promptly, accurate, and pro- (iii) All proficiency testing reports
ficiently and for assuring compliance received are reviewed by the appro-
with the applicable regulations. priate staff to evaluate the labora-
(a) The laboratory director, if quali- tory’s performance and to identify any
fied, may perform the duties of the problems that require corrective ac-
technical consultant, clinical consult- tion; and

ant, and testing personnel, or delegate (iv) An approved corrective action
these responsibilities to personnel plan is followed when any proficiency
699
§ 493.1409 42 CFR Ch. IV (10–1–17 Edition)
testing results are found to be unac- (13) Ensure that an approved proce-
ceptable or unsatisfactory; dure manual is available to all per-
(5) Ensure that the quality control sonnel responsible for any aspect of the
and quality assessment programs are testing process; and
established and maintained to assure (14) Specify, in writing, the respon-
the quality of laboratory services pro- sibilities and duties of each consultant
vided and to identify failures in quality and each person, engaged in the per-
as they occur; formance of the preanalytic, analytic,
(6) Ensure the establishment and and postanalytic phases of testing,
maintenance of acceptable levels of an- that identifies which examinations and
alytical performance for each test sys- procedures each individual is author-
tem; ized to perform, whether supervision is
(7) Ensure that all necessary reme- required for specimen processing, test
dial actions are taken and documented performance or results reporting, and
whenever significant deviations from whether consultant or director review
the laboratory’s established perform- is required prior to reporting patient
ance specifications are identified, and test results.
that patient test results are reported
only when the system is functioning
FR 3713, Jan. 24, 2003]
properly;
(8) Ensure that reports of test results § 493.1409 Condition: Laboratories per-
include pertinent information required forming moderate complexity test-
for interpretation; ing; technical consultant.
(9) Ensure that consultation is avail-
The laboratory must have a technical
able to the laboratory’s clients on mat-
consultant who meets the qualification
ters relating to the quality of the test
requirements of § 493.1411 of this sub-
results reported and their interpreta-
part and provides technical oversight
tion concerning specific patient condi-
in accordance with § 493.1413 of this
tions;
subpart.
(10) Employ a sufficient number of
laboratory personnel with the appro- § 493.1411 Standard; Technical con-
priate education and either experience sultant qualifications.
or training to provide appropriate con-
sultation, properly supervise and accu- The laboratory must employ one or
rately perform tests and report test re- more individuals who are qualified by
sults in accordance with the personnel education and either training or expe-
responsibilities described in this sub- rience to provide technical consulta-
part; tion for each of the specialties and sub-
(11) Ensure that prior to testing pa- specialties of service in which the lab-
tients’ specimens, all personnel have oratory performs moderate complexity
the appropriate education and experi- tests or procedures. The director of a
ence, receive the appropriate training laboratory performing moderate com-
for the type and complexity of the plexity testing may function as the
services offered, and have dem- technical consultant provided he or she
onstrated that they can perform all meets the qualifications specified in
testing operations reliably to provide this section.
and report accurate results; (a) The technical consultant must
(12) Ensure that policies and proce- possess a current license issued by the
dures are established for monitoring State in which the laboratory is lo-
individuals who conduct preanalytical, cated, if such licensing is required.
analytical, and postanalytical phases (b) The technical consultant must—
of testing to assure that they are com- (1) (i) Be a doctor of medicine or doc-
petent and maintain their competency tor of osteopathy licensed to practice
to process specimens, perform test pro- medicine or osteopathy in the State in
cedures and report test results prompt- which the laboratory is located; and
ly and proficiently, and whenever nec- (ii) Be certified in anatomic or clin-
essary, identify needs for remedial ical pathology, or both, by the Amer-
training or continuing education to im- ican Board of Pathology or the Amer-
prove skills; ican Osteopathic Board of Pathology or
700
possess qualifications that are equiva- § 493.1413 Standard; Technical con-

lent to those required for such certifi- sultant responsibilities.
cation; or The technical consultant is respon-
(2)(i) Be a doctor of medicine, doctor sible for the technical and scientific
of osteopathy, or doctor of podiatric oversight of the laboratory. The tech-
medicine licensed to practice medicine, nical consultant is not required to be
osteopathy, or podiatry in the State in onsite at all times testing is per-
which the laboratory is located; and formed; however, he or she must be
(ii) Have at least one year of labora- available to the laboratory on an as
tory training or experience, or both in needed basis to provide consultation,
non-waived testing, in the designated as specified in paragraph (a) of this sec-
specialty or subspecialty areas of serv- tion.
ice for which the technical consultant (a) The technical consultant must be
accessible to the laboratory to provide
is responsible (for example, physicians
on-site, telephone, or electronic con-
certified either in hematology or he-
sultation; and
matology and medical oncology by the (b) The technical consultant is re-
American Board of Internal Medicine sponsible for—
are qualified to serve as the technical (1) Selection of test methodology ap-
consultant in hematology); or propriate for the clinical use of the test
(3)(i) Hold an earned doctoral or mas- results;
ter’s degree in a chemical, physical, bi- (2) Verification of the test procedures
ological or clinical laboratory science performed and the establishment of the
or medical technology from an accred- laboratory’s test performance charac-
ited institution; and teristics, including the precision and
(ii) Have at least one year of labora- accuracy of each test and test system;
tory training or experience, or both in (3) Enrollment and participation in
non-waived testing, in the designated an HHS approved proficiency testing
specialty or subspecialty areas of serv- program commensurate with the serv-
ice for which the technical consultant ices offered;
is responsible; or (4) Establishing a quality control
program appropriate for the testing
(4)(i) Have earned a bachelor’s degree
performed and establishing the param-
in a chemical, physical or biological
eters for acceptable levels of analytic
science or medical technology from an performance and ensuring that these
accredited institution; and levels are maintained throughout the
(ii) Have at least 2 years of labora- entire testing process from the initial
tory training or experience, or both in receipt of the specimen, through sam-
non-waived testing, in the designated ple analysis and reporting of test re-
specialty or subspecialty areas of serv- sults;
ice for which the technical consultant (5) Resolving technical problems and
is responsible. ensuring that remedial actions are
taken whenever test systems deviate
NOTE: The technical consultant require-
ments for ‘‘laboratory training or experi-
from the laboratory’s established per-
ence, or both’’ in each specialty or sub- formance specifications;
specialty may be acquired concurrently in (6) Ensuring that patient test results
more than one of the specialties or sub- are not reported until all corrective ac-
specialties of service, excluding waived tests. tions have been taken and the test sys-
For example, an individual who has a bach- tem is functioning properly;
elor’s degree in biology and additionally has (7) Identifying training needs and as-
documentation of 2 years of work experience suring that each individual performing
performing tests of moderate complexity in tests receives regular in-service train-
all specialties and subspecialties of service, ing and education appropriate for the
would be qualified as a technical consultant type and complexity of the laboratory
in a laboratory performing moderate com- services performed;
plexity testing in all specialties and sub- (8) Evaluating the competency of all
specialties of service.
testing personnel and assuring that the
[57 FR 7172, Feb. 28, 1992, as amended at 58 staff maintain their competency to
FR 5234, Jan. 19, 1993] perform test procedures and report test
701
§ 493.1415 42 CFR Ch. IV (10–1–17 Edition)
results promptly, accurately and pro- (b) Be a doctor of medicine, doctor of

ficiently. The procedures for evalua- osteopathy or doctor of podiatric medi-
tion of the competency of the staff cine and possess a license to practice
must include, but are not limited to— medicine, osteopathy or podiatry in
(i) Direct observations of routine pa- the State in which the laboratory is lo-
tient test performance, including pa- cated.
tient preparation, if applicable, speci- [57 FR 7172, Feb. 28, 1992, as amended at 58
men handling, processing and testing; FR 5234, Jan. 19, 1993]
(ii) Monitoring the recording and re-
porting of test results; § 493.1419 Standard; Clinical consult-
(iii) Review of intermediate test re- ant responsibilities.
sults or worksheets, quality control The clinical consultant provides con-
records, proficiency testing results, sultation regarding the appropriate-
and preventive maintenance records; ness of the testing ordered and inter-
(iv) Direct observation of perform- pretation of test results. The clinical
ance of instrument maintenance and consultant must—
function checks; (a) Be available to provide clinical
(v) Assessment of test performance consultation to the laboratory’s cli-
through testing previously analyzed ents;
specimens, internal blind testing sam- (b) Be available to assist the labora-
ples or external proficiency testing tory’s clients in ensuring that appro-
samples; and priate tests are ordered to meet the
(vi) Assessment of problem solving clinical expectations;
skills; and (c) Ensure that reports of test results
include pertinent information required
(9) Evaluating and documenting the
for specific patient interpretation; and
performance of individuals responsible
(d) Ensure that consultation is avail-
for moderate complexity testing at
able and communicated to the labora-
least semiannually during the first
tory’s clients on matters related to the
year the individual tests patient speci-
quality of the test results reported and
mens. Thereafter, evaluations must be
their interpretation concerning spe-
performed at least annually unless test
cific patient conditions.
methodology or instrumentation
changes, in which case, prior to report- § 493.1421 Condition: Laboratories per-
ing patient test results, the individ- forming moderate complexity test-
ual’s performance must be reevaluated ing; testing personnel.
to include the use of the new test The laboratory must have a suffi-
methodology or instrumentation. cient number of individuals who meet
the qualification requirements of
§ 493.1415 Condition: Laboratories per-
forming moderate complexity test- § 493.1423, to perform the functions
ing; clinical consultant. specified in § 493.1425 for the volume
and complexity of tests performed.
The laboratory must have a clinical
consultant who meets the qualification § 493.1423 Standard; Testing personnel
requirements of § 493.1417 of this part qualifications.
and provides clinical consultation in Each individual performing moderate
accordance with § 493.1419 of this part. complexity testing must—
(a) Possess a current license issued
§ 493.1417 Standard; Clinical consult- by the State in which the laboratory is
ant qualifications.
located, if such licensing is required;
The clinical consultant must be and
qualified to consult with and render (b) Meet one of the following require-
opinions to the laboratory’s clients ments:
concerning the diagnosis, treatment (1) Be a doctor of medicine or doctor
and management of patient care. The of osteopathy licensed to practice med-
clinical consultant must— icine or osteopathy in the State in
(a) Be qualified as a laboratory direc- which the laboratory is located or have

tor under § 493.1405(b) (1), (2), or (3)(i); earned a doctoral, master’s, or bach-
or elor’s degree in a chemical, physical,
702
biological or clinical laboratory (a) Each individual performs only

science, or medical technology from an those moderate complexity tests that
accredited institution; or are authorized by the laboratory direc-
(2) Have earned an associate degree tor and require a degree of skill com-
in a chemical, physical or biological mensurate with the individual’s edu-
science or medical laboratory tech- cation, training or experience, and
nology from an accredited institution; technical abilities.
or (b) Each individual performing mod-
(3) Be a high school graduate or erate complexity testing must—
equivalent and have successfully com- (1) Follow the laboratory’s proce-
pleted an official military medical lab- dures for specimen handling and proc-
oratory procedures course of at least 50 essing, test analyses, reporting and
weeks duration and have held the mili- maintaining records of patient test re-
tary enlisted occupational specialty of sults;
Medical Laboratory Specialist (Labora- (2) Maintain records that dem-
tory Technician); or
onstrate that proficiency testing sam-
(4)(i) Have earned a high school di-
ples are tested in the same manner as
ploma or equivalent; and
patient samples;
(ii) Have documentation of training
appropriate for the testing performed (3) Adhere to the laboratory’s quality
prior to analyzing patient specimens. control policies, document all quality
Such training must ensure that the in- control activities, instrument and pro-
dividual has— cedural calibrations and maintenance
(A) The skills required for proper performed;
specimen collection, including patient (4) Follow the laboratory’s estab-
preparation, if applicable, labeling, lished corrective action policies and
handling, preservation or fixation, procedures whenever test systems are
processing or preparation, transpor- not within the laboratory’s established
tation and storage of specimens; acceptable levels of performance;
(B) The skills required for imple- (5) Be capable of identifying problems
menting all standard laboratory proce- that may adversely affect test perform-
dures; ance or reporting of test results and ei-
(C) The skills required for performing ther must correct the problems or im-
each test method and for proper instru- mediately notify the technical consult-
ment use; ant, clinical consultant or director;
(D) The skills required for per- and
forming preventive maintenance, trou- (6) Document all corrective actions
bleshooting and calibration procedures taken when test systems deviate from
related to each test performed; the laboratory’s established perform-
(E) A working knowledge of reagent ance specifications.
stability and storage;
(F) The skills required to implement LABORATORIES PERFORMING HIGH
the quality control policies and proce- COMPLEXITY TESTING
dures of the laboratory;
(G) An awareness of the factors that § 493.1441 Condition: Laboratories per-
influence test results; and forming high complexity testing;
(H) The skills required to assess and laboratory director.
verify the validity of patient test re- The laboratory must have a director
sults through the evaluation of quality who meets the qualification require-
control sample values prior to report- ments of § 493.1443 of this subpart and
ing patient test results. provides overall management and di-
[57 FR 7172, Feb. 28, 1992, as amended at 58 rection in accordance with § 493.1445 of
FR 5234, Jan. 19, 1993] this subpart.
§ 493.1425 Standard; Testing personnel § 493.1443 Standard; Laboratory direc-

responsibilities. tor qualifications.
The testing personnel are responsible The laboratory director must be

for specimen processing, test perform- qualified to manage and direct the lab-
ance, and for reporting test results. oratory personnel and performance of
703
§ 493.1445 42 CFR Ch. IV (10–1–17 Edition)
high complexity tests and must be eli- (5) On or before February 28, 1992, be
gible to be an operator of a laboratory qualified under State law to direct a
within the requirements of subpart R. laboratory in the State in which the
(a) The laboratory director must pos- laboratory is located; or
sess a current license as a laboratory (6) For the subspecialty of oral pa-
director issued by the State in which thology, be certified by the American
the laboratory is located, if such li- Board of Oral Pathology, American
censing is required; and Board of Pathology, the American Os-
(b) The laboratory director must— teopathic Board of Pathology, or pos-
(1)(i) Be a doctor of medicine or doc- sess qualifications that are equivalent
tor of osteopathy licensed to practice to those required for certification.
medicine or osteopathy in the State in
which the laboratory is located; and [57 FR 7172, Feb. 28, 1992, as amended at 58
FR 5234, Jan. 19, 1993; 59 FR 62609, Dec. 6,
(ii) Be certified in anatomic or clin- 1994; 62 FR 25858, May 12, 1997; 63 FR 55034,
ical pathology, or both, by the Amer- Oct. 14, 1998; 65 FR 82944, Dec. 29, 2000; 68 FR
ican Board of Pathology or the Amer- 3713, Jan. 24, 2003]
ican Osteopathic Board of Pathology or
possess qualifications that are equiva- § 493.1445 Standard; Laboratory direc-
lent to those required for such certifi- tor responsibilities.
cation; or The laboratory director is respon-
(2) Be a doctor of medicine, a doctor sible for the overall operation and ad-
of osteopathy or doctor of podiatric ministration of the laboratory, includ-
medicine licensed to practice medicine, ing the employment of personnel who
osteopathy or podiatry in the State in are competent to perform test proce-
which the laboratory is located; and dures, record and report test results
(i) Have at least one year of labora- promptly, accurately and proficiently,
tory training during medical residency and for assuring compliance with the
(for example, physicians certified ei- applicable regulations.
ther in hematology or hematology and
(a) The laboratory director, if quali-
medical oncology by the American
fied, may perform the duties of the
Board of Internal Medicine); or
technical supervisor, clinical consult-
(ii) Have at least 2 years of experi-
ant, general supervisor, and testing
ence directing or supervising high com-
personnel, or delegate these respon-
plexity testing; or
sibilities to personnel meeting the
(3) Hold an earned doctoral degree in
qualifications under §§ 493.1447, 493.1453,
a chemical, physical, biological, or
493.1459, and 493.1487, respectively.
clinical laboratory science from an ac-
credited institution and— (b) If the laboratory director reappor-
tions performance of his or her respon-
(i) Be certified and continue to be
certified by a board approved by HHS; sibilities, he or she remains responsible
or for ensuring that all duties are prop-
erly performed.
(ii) Before February 24, 2003, must
have served or be serving as a director (c) The laboratory director must be
of a laboratory performing high com- accessible to the laboratory to provide
plexity testing and must have at onsite, telephone or electronic con-
least— sultation as needed.
(A) Two years of laboratory training (d) Each individual may direct no
or experience, or both; and more than five laboratories.
(B) Two years of laboratory experi- (e) The laboratory director must—
ence directing or supervising high com- (1) Ensure that testing systems de-
plexity testing. veloped and used for each of the tests
(4) Be serving as a laboratory direc- performed in the laboratory provide
tor and must have previously qualified quality laboratory services for all as-
or could have qualified as a laboratory pects of test performance, which in-
director under regulations at 42 CFR cludes the preanalytic, analytic, and
493.1415, published March 14, 1990 at 55 postanalytic phases of testing;

FR 9538, on or before February 28, 1992; (2) Ensure that the physical plant
or and environmental conditions of the
704
laboratory are appropriate for the test- (9) Ensure that consultation is avail-
ing performed and provide a safe envi- able to the laboratory’s clients on mat-
ronment in which employees are pro- ters relating to the quality of the test
tected from physical, chemical, and bi- results reported and their interpreta-
ological hazards; tion concerning specific patient condi-
(3) Ensure that— tions;
(i) The test methodologies selected (10) Ensure that a general supervisor
have the capability of providing the provides on-site supervision of high
quality of results required for patient complexity test performance by testing
care; personnel qualified under
(ii) Verification procedures used are § 493.1489(b)(4);
adequate to determine the accuracy, (11) Employ a sufficient number of
precision, and other pertinent perform- laboratory personnel with the appro-
ance characteristics of the method; and priate education and either experience
(iii) Laboratory personnel are per- or training to provide appropriate con-
forming the test methods as required sultation, properly supervise and accu-
for accurate and reliable results; rately perform tests and report test re-
(4) Ensure that the laboratory is en- sults in accordance with the personnel
rolled in an HHS-approved proficiency responsibilities described in this sub-
testing program for the testing per- part;
formed and that—
(12) Ensure that prior to testing pa-
(i) The proficiency testing samples tients’ specimens, all personnel have
are tested as required under subpart H the appropriate education and experi-
of this part;
ence, receive the appropriate training
(ii) The results are returned within for the type and complexity of the
the timeframes established by the pro-
services offered, and have dem-
ficiency testing program;
onstrated that they can perform all
(iii) All proficiency testing reports
testing operations reliably to provide
received are reviewed by the appro-
and report accurate results;
priate staff to evaluate the labora-
tory’s performance and to identify any (13) Ensure that policies and proce-
problems that require corrective ac- dures are established for monitoring
tion; and individuals who conduct preanalytical,
(iv) An approved corrective action analytical, and postanalytical phases
plan is followed when any proficiency of testing to assure that they are com-
testing result is found to be unaccept- petent and maintain their competency
able or unsatisfactory; to process specimens, perform test pro-
(5) Ensure that the quality control cedures and report test results prompt-
and quality assessment programs are ly and proficiently, and whenever nec-
established and maintained to assure essary, identify needs for remedial
the quality of laboratory services pro- training or continuing education to im-
vided and to identify failures in quality prove skills;
as they occur; (14) Ensure that an approved proce-
(6) Ensure the establishment and dure manual is available to all per-
maintenance of acceptable levels of an- sonnel responsible for any aspect of the
alytical performance for each test sys- testing process; and
tem; (15) Specify, in writing, the respon-
(7) Ensure that all necessary reme- sibilities and duties of each consultant
dial actions are taken and documented and each supervisor, as well as each
whenever significant deviations from person engaged in the performance of
the laboratory’s established perform- the preanalytic, analytic, and
ance characteristics are identified, and postanalytic phases of testing, that
that patient test results are reported identifies which examinations and pro-
only when the system is functioning cedures each individual is authorized
properly; to perform, whether supervision is re-
(8) Ensure that reports of test results quired for specimen processing, test
include pertinent information required performance or result reporting and
for interpretation; whether supervisory or director review
705
§ 493.1447 42 CFR Ch. IV (10–1–17 Edition)
is required prior to reporting patient (1)(i) Be a doctor of medicine or doc-

test results. tor of osteopathy licensed to practice
medicine or osteopathy in the State in
FR 3714, Jan. 24, 2003] which the laboratory is located; and
(ii) Be certified in clinical pathology
§ 493.1447 Condition: Laboratories per- by the American Board of Pathology or
forming high complexity testing; the American Osteopathic Board of Pa-
technical supervisor. thology or possess qualifications that
The laboratory must have a technical are equivalent to those required for
supervisor who meets the qualification such certification; or
requirements of § 493.1449 of this sub- (2)(i) Be a doctor of medicine, doctor
part and provides technical supervision of osteopathy, or doctor of podiatric
in accordance with § 493.1451 of this medicine licensed to practice medicine,
subpart. osteopathy, or podiatry in the State in
which the laboratory is located; and
§ 493.1449 Standard; Technical super- (ii) Have at least one year of labora-
visor qualifications. tory training or experience, or both, in
The laboratory must employ one or high complexity testing within the spe-
more individuals who are qualified by cialty of microbiology with a minimum
education and either training or expe- of 6 months experience in high com-
rience to provide technical supervision plexity testing within the subspecialty
for each of the specialties and sub- of bacteriology; or
specialties of service in which the lab- (3)(i) Have an earned doctoral degree
oratory performs high complexity tests in a chemical, physical, biological or
or procedures. The director of a labora- clinical laboratory science from an ac-
tory performing high complexity test- credited institution; and
ing may function as the technical su- (ii) Have at least 1 year of laboratory
pervisor provided he or she meets the training or experience, or both, in high
qualifications specified in this section. complexity testing within the spe-
(a) The technical supervisor must cialty of microbiology with a minimum
possess a current license issued by the of 6 months experience in high com-
State in which the laboratory is lo- plexity testing within the subspecialty
cated, if such licensing is required; and of bacteriology; or
(b) The laboratory may perform ana- (4)(i) Have earned a master’s degree
tomic and clinical laboratory proce- in a chemical, physical, biological or
dures and tests in all specialties and clinical laboratory science or medical
subspecialties of services except technology from an accredited institu-
histocompatibility and clinical cyto- tion; and
genetics services provided the indi- (ii) Have at least 2 years of labora-
vidual functioning as the technical su- tory training or experience, or both, in
pervisor— high complexity testing within the spe-
(1) Is a doctor of medicine or doctor cialty of microbiology with a minimum
of osteopathy licensed to practice med- of 6 months experience in high com-
icine or osteopathy in the State in plexity testing within the subspecialty
which the laboratory is located; and of bacteriology; or
(2) Is certified in both anatomic and (5)(i) Have earned a bachelor’s degree
clinical pathology by the American in a chemical, physical, or biological
Board of Pathology or the American science or medical technology from an
Osteopathic Board of Pathology or Pos- accredited institution; and
sesses qualifications that are equiva- (ii) Have at least 4 years of labora-
lent to those required for such certifi- tory training or experience, or both, in
cation. high complexity testing within the spe-
(c) If the requirements of paragraph cialty of microbiology with a minimum
(b) of this section are not met and the of 6 months experience in high com-
laboratory performs tests in the sub- plexity testing within the subspecialty
specialty of bacteriology, the indi- of bacteriology.

vidual functioning as the technical su- (d) If the requirements of paragraph
pervisor must— (b) of this section are not met and the
706
specialty of mycobacteriology, the in- of mycobacteriology.
dividual functioning as the technical (e) If the requirements of paragraph
supervisor must— (b) of this section are not met and the
(1)(i) Be a doctor of medicine or doc- laboratory performs tests in the sub-
tor of osteopathy licensed to practice specialty of mycology, the individual
medicine or osteopathy in the State in functioning as the technical supervisor
which the laboratory is located; and must—
(ii) Be certified in clinical pathology (1)(i) Be a doctor of medicine or doc-
by the American Board of Pathology or tor of osteopathy licensed to practice
the American Osteopathic Board of Pa- medicine or osteopathy in the State in
thology or possess qualifications that which the laboratory is located; and
are equivalent to those required for (ii) Be certified in clinical pathology
such certification; or by the American Board of Pathology or
(2)(i) Be a doctor of medicine, doctor the American osteopathic Board of Pa-
of osteopathy, or doctor or podiatric thology or possess qualifications that
medicine licensed to practice medicine, are equivalent to those required for
osteopathy, or podiatry in the State in such certification; or
which the laboratory is located; and (2)(i) Be a doctor of medicine, doctor
of osteopathy, or doctor of podiatric
(ii) Have at least 1 year of laboratory
medicine licensed to practice medicine,
training or experience, or both, in high
osteopathy, or podiatry in the State in
complexity testing within the spe-
cialty of microbiology with a minimum
of 6 months experience in high com-
plexity testing within the subspecialty
complexity testing within the spe-
of mycobacteriology; or
cialty of microbiology with a minimum
(3)(i) Have an earned doctoral degree of 6 months experience in high com-
in a chemical, physical, biological or plexity testing within the subspecialty
clinical laboratory science from an ac- of mycology; or
credited institution; and (3)(i) Have an earned doctoral degree
(ii) Have at least 1 year of laboratory in a chemical, physical, biological or
training or experience, or both, in high clinical laboratory science from an ac-
complexity testing within the spe- credited institution; and
cialty of microbiology with a minimum (ii) Have at least 1 year of laboratory
of 6 months experience in high com- training or experience, or both in high
plexity testing within the subspecialty complexity testing within the spe-
of mycobacteriology; or ciality of microbiology with a min-
(4)(i) Have earned a master’s degree imum of 6 months experience in high
in a chemical, physical, biological or complexity testing within the sub-
clinical laboratory science or medical specialty of mycology; or
technology from an accredited institu- (4)(i) Have earned a master’s degree
tion; and in a chemical, physical, biological or
(ii) Have at least 2 years of labora- clinical laboratory science or medical
tory training or experience, or both, in technology from an accredited institu-
high complexity testing within the spe- tion; and
cialty of microbiology with a minimum (ii) Have at least 2 years of labora-
of 6 months experience in high com- tory training or experience, or both, in
plexity testing within the subspecialty high complexity testing within the spe-
of mycobacteriology; or cialty of microbiology with a minimum
(5)(i) Have earned a bachelor’s degree of 6 months experience in high com-
in a chemical, physical or biological plexity testing within the subspecialty
science or medical technology from an of mycology; or
accredited institution; and (5)(i) Have earned a bachelor’s degree
(ii) Have at least 4 years of labora- in a chemical, physical or biological
tory training or experience, or both, in science or medical technology from an
high complexity testing within the spe- accredited institution; and

cialty of microbiology with a minimum (ii) Have at least 4 years of labora-
of 6 months experience in high com- tory training or experience, or both, in
707
§ 493.1449 42 CFR Ch. IV (10–1–17 Edition)
high complexity testing within the spe- science or medical technology from an
cialty of microbiology with a minimum accredited institution; and
of 6 months experience in high com- (ii) Have at least 4 years of labora-
plexity testing within the subspecialty tory training or experience, or both, in
of mycology. high complexity testing within the spe-
(f) If the requirements of paragraph cialty of microbiology with a minimum
(b) of this section are not met and the of 6 months experience in high com-
specialty of parasitology, the indi- of parasitology.
vidual functioning as the technical su- (g) If the requirements of paragraph
pervisor must— (b) of this section are not met and the
(1)(i) Be a doctor of medicine or a
laboratory performs tests in the sub-
doctor of osteopathy licensed to prac-
specialty of virology, the individual
tice medicine or osteopathy in the
functioning as the technical supervisor
State in which the laboratory is lo-
must—
cated; and
(ii) Be certified in clinical pathology (1)(i) Be a doctor of medicine or doc-
by the American Board of Pathology or tor of osteopathy licensed to practice
the American Osteopathic Board of Pa- medicine or osteopathy in the State in
thology or possess qualifications that which the laboratory is located; and
are equivalent to those required for (ii) Be certified in clinical pathology
such certification; or by the American Board of Pathology or
(2)(i) Be a doctor of medicine, doctor the American Osteopathic Board of Pa-
of osteopathy, or doctor of podiatric thology or possess qualifications that
medicine licensed to practice medicine, are equivalent to those required for
osteopathy, or podiatry in the State in such certification; or
which the laboratory is located; and (2)(i) Be a doctor of medicine, doctor
(ii) Have at least one year of labora- of osteopathy, or doctor of podiatric
tory training or experience, or both, in medicine licensed to practice medicine,
high complexity testing within the spe- osteopathy, or podiatry in the State in
cialty of microbiology with a minimum which the laboratory is located; and
of 6 months experience in high com- (ii) Have at least 1 year of laboratory
plexity testing within the subspecialty training or experience, or both, in high
of parasitology; complexity testing within the spe-
(3)(i) Have an earned doctoral degree cialty of microbiology with a minimum
in a chemical, physical, biological or of 6 months experience in high com-
clinical laboratory science from an ac- plexity testing within the subspecialty
credited institution; and of virology; or
(ii) Have at least 1 year of laboratory (3)(i) Have an earned doctoral degree
training or experience, or both, in high in a chemical, physical, biological or
complexity testing within the spe- clinical laboratory science from an ac-
cialty of microbiology with a minimum credited institution; and
of 6 months experience in high com-
plexity testing within the subspecialty
of parasitology; or
(4)(i) Have earned a master’s degree complexity testing within the spe-
in a chemical, physical, biological or cialty of microbiology with a minimum
clinical laboratory science or medical of 6 months experience in high com-
technology from an accredited institu- plexity testing within the subspecialty
tion; and of virology; or
(ii) Have at least 2 years of labora- (4)(i) Have earned a master’s degree
tory training or experience, or both, in in a chemical, physical, biological or
high complexity testing within the spe- clinical laboratory science or medical
cialty of microbiology with a minimum technology from an accredited institu-
of 6 months experience in high com- tion; and
plexity testing within the subspecialty (ii) Have at least 2 years of labora-
of parasitology; or tory training or experience, or both, in

(5)(i) Have earned a bachelor’s degree high complexity testing within the spe-
in a chemical, physical or biological cialty of microbiology with a minimum
708
of 6 months experience in high com- cal science or medical technology from

plexity testing within the subspecialty an accredited institution; and
of virology; or (ii) Have at least 4 years of labora-
(5)(i) Have earned a bachelor’s degree tory training or experience, or both, in
in a chemical, physical or biological high complexity testing for the spe-
science or medical technology from an cialty of diagnostic immunology.
accredited institution; and (i) If the requirements of paragraph
(ii) Have at least 4 years of labora- (b) of this section are not met and the
tory training or experience, or both, in laboratory performs tests in the spe-
high complexity testing within the specialty of chemistry, the individual
cialty of microbiology with a minimum functioning as the technical supervisor
of 6 months experience in high com- must—
plexity testing within the subspecialty (1)(i) Be a doctor of medicine or doc-
of virology. tor of osteopathy licensed to practice
(h) If the requirements of paragraph medicine or osteopathy in the State in
(b) of this section are not met and the which the laboratory is located; and
laboratory performs tests in the spe- (ii) Be certified in clinical pathology
cialty of diagnostic immunology, the by the American Board of Pathology or
individual functioning as the technical the American Osteopathic Board of Pa-
supervisor must— thology or possess qualifications that
(1)(i) Be a doctor of medicine or a are equivalent to those required for
doctor of osteopathy licensed to prac- such certification; or
tice medicine or osteopathy in the (2)(i) Be a doctor of medicine, doctor
State in which the laboratory is lo- of osteopathy, or doctor of podiatric
cated; and medicine licensed to practice medicine,
(ii) Be certified in clinical pathology osteopathy, or podiatry in the State in
by the American Board of Pathology or which the laboratory is located; and
the American Osteopathic Board of Pa-
thology or possess qualifications that
are equivalent to those required for
complexity testing for the specialty of
such certification; or
chemistry; or
(2)(i) Be a doctor of medicine, doctor
(3)(i) Have an earned doctoral degree
of osteopathy, or doctor of podiatric
in a chemical, physical, biological or
medicine licensed to practice medicine,
clinical laboratory science from an ac-
osteopathy, or podiatry in the State in
credited institution; and
(ii) Have at least 1 year of laboratory (ii) Have at least 1 year of laboratory
training or experience, or both, in high training or experience, or both, in high
complexity testing for the specialty of complexity testing within the spe-
diagnostic immunology; or cialty of chemistry; or
(3)(i) Have an earned doctoral degree (4)(i) Have earned a master’s degree
in a chemical, physical, biological or in a chemical, physical, biological or
clinical laboratory science from an ac- clinical laboratory science or medical
credited institution; and technology from an accredited institu-
(ii) Have at least 1 year of laboratory tion; and
training or experience, or both, in high (ii) Have at least 2 years of labora-
complexity testing within the spe- tory training or experience, or both, in
cialty of diagnostic immunology; or high complexity testing for the spe-
(4)(i) Have earned a master’s degree cialty of chemistry; or
in a chemical, physical, biological or (5)(i) Have earned a bachelor’s degree
clinical laboratory science or medical in a chemical, physical or biological
technology from an accredited institu- science or medical technology from an
tion; and accredited institution; and
(ii) Have at least 2 years of labora- (ii) Have at least 4 years of labora-
tory training or experience, or both, in tory training or experience, or both, in
high complexity testing for the spe- high complexity testing for the spe-
cialty of diagnostic immunology; or cialty of chemistry.

(5) (i) Have earned a bachelor’s de- (j) If the requirements of paragraph
gree in a chemical, physical or biologi- (b) of this section are not met and the
709
§ 493.1449 42 CFR Ch. IV (10–1–17 Edition)
laboratory performs tests in the spe- (i) Be a doctor of medicine or a doc-

cialty of hematology, the individual tor of osteopathy licensed to practice
functioning as the technical supervisor medicine or osteopathy in the State in
must— which the laboratory is located; and
(1)(i) Be a doctor of medicine or a (ii) Meet one of the following require-
doctor of osteopathy licensed to prac- ments—
tice medicine or osteopathy in the (A) Be certified in anatomic pathol-
State in which the laboratory is lo- ogy by the American Board of Pathol-
cated; and ogy or the American Osteopathic Board
(ii) Be certified in clinical pathology of Pathology or possess qualifications
by the American Board of Pathology or that are equivalent to those required
the American Osteopathic Board of Pa- for such certification; or
thology or possess qualifications that (B) Be certified by the American So-
are equivalent to those required for ciety of Cytology to practice
such certification; or cytopathology or possess qualifications
(2)(i) Be a doctor of medicine, doctor that are equivalent to those required
of osteopathy, or doctor of podiatric for such certification;
medicine licensed to practice medicine, (2) An individual qualified under
osteopathy, or podiatry in the State in § 493.1449(b) or paragraph (k)(1) of this
which the laboratory is located; and section may delegate some of the cy-
(ii) Have at least one year of labora- tology technical supervisor responsibil-
tory training or experience, or both, in ities to an individual who is in the
high complexity testing for the spe- final year of full-time training leading
cialty of hematology (for example, to certification specified in paragraphs
physicians certified either in hema- (b) or (k)(1)(ii)(A) of this section pro-
tology or hematology and medical on- vided the technical supervisor qualified
cology by the American Board of Inter- under § 493.1449(b) or paragraph (k)(1) of
nal Medicine); or this section remains ultimately respon-
(3)(i) Have an earned doctoral degree sible for ensuring that all of the re-
in a chemical, physical, biological or sponsibilities of the cytology technical
clinical laboratory science from an ac- supervisor are met.
credited institution; and (l) If the requirements of paragraph
(ii) Have at least 1 year of laboratory (b) of this section are not met and the
training or experience, or both, in high laboratory performs tests in the sub-
complexity testing within the spe- specialty of histopathology, the indi-
cialty of hematology; or vidual functioning as the technical su-
(4)(i) Have earned a master’s degree pervisor must—
in a chemical, physical, biological or (1) Meet one of the following require-
clinical laboratory science or medical ments:
technology from an accredited institu- (i) (A) Be a doctor of medicine or a
tion; and doctor of osteopathy licensed to prac-
(ii) Have at least 2 years of labora- tice medicine or osteopathy in the
tory training or experience, or both, in State in which the laboratory is lo-
high complexity testing for the spe- cated; and
cialty of hematology; or (B) Be certified in anatomic pathol-
(5)(i) Have earned a bachelor’s degree ogy by the American Board of Pathol-
in a chemical, physical or biological ogy or the American Osteopathic Board
science or medical technology from an of Pathology or possess qualifications
accredited institution; and that are equivalent to those required
(ii) Have at least 4 years of labora- for such certification;
tory training or experience, or both, in (ii) An individual qualified under
high complexity testing for the spe- § 493.1449(b) or paragraph (l)(1) of this
cialty of hematology. section may delegate to an individual
(k)(1) If the requirements of para- who is a resident in a training program
graph (b) of this section are not met leading to certification specified in
and the laboratory performs tests in paragraph (b) or (l)(1)(i)(B) of this sec-
the subspecialty of cytology, the indi- tion, the responsibility for examina-
vidual functioning as the technical su- tion and interpretation of
pervisor must— histopathology specimens.
710
(2) For tests in dermatopathology, (ii) An individual qualified under

meet one of the following require- § 493.1449(b) or paragraph (1)(3)(i) of this
ments: section may delegate to an individual
(i) (A) Be a doctor of medicine or doc- who is a resident in a training program
tor of osteopathy licensed to practice leading to certification specified in
medicine or osteopathy in the State in paragraphs (b) or (1)(3)(i)(B) of this sec-
which the laboratory is located and— tion, the responsibility for examina-
(B) Meet one of the following require- tion and interpretation of ophthalmic
ments: specimens; or
(1) Be certified in anatomic pathol- (m) If the requirements of paragraph
ogy by the American Board of Pathol- (b) of this section are not met and the
ogy or the American Osteopathic Board laboratory performs tests in the sub-
of Pathology or possess qualifications specialty of oral pathology, the indi-
that are equivalent to those required vidual functioning as the technical su-
for such certification; or pervisor must meet one of the fol-
(2) Be certified in dermatopathology lowing requirements:
by the American Board of Dermatology (1)(i) Be a doctor of medicine or a
and the American Board of Pathology doctor of osteopathy licensed to prac-
or possess qualifications that are tice medicine or osteopathy in the
equivalent to those required for such State in which the laboratory is lo-
certification; or cated and—
(ii) Be certified in anatomic pathol-
(3) Be certified in dermatology by the
ogy by the American Board of Pathol-
American Board of Dermatology or
ogy or the American Osteopathic Board
possess qualifications that are equiva-
of Pathology or possess qualifications
lent to those required for such certifi-
that are equivalent to those required
cation; or
for such certification; or
(ii) An individual qualified under (2) Be certified in oral pathology by
§ 493.1449(b) or paragraph (l)(2)(i) of this the American Board of Oral Pathology
section may delegate to an individual or possess qualifications for such cer-
who is a resident in a training program tification; or
leading to certification specified in (3) An individual qualified under
paragraphs (b) or (l)(2)(i)(B) of this sec- § 493.1449(b) or paragraph (m) (1) or (2)
tion, the responsibility for examina- of this section may delegate to an indi-
tion and interpretation of vidual who is a resident in a training
dermatopathology specimens. program leading to certification speci-
(3) For tests in ophthalmic pathol- fied in paragraphs (b) or (m) (1) or (2) of
ogy, meet one of the following require- this section, the responsibility for ex-
ments: amination and interpretation of oral
(i)(A) Be a doctor of medicine or doc- pathology specimens.
tor of osteopathy licensed to practice (n) If the requirements of paragraph
medicine or osteopathy in the State in (b) of this section are not met and the
which the laboratory is located and— laboratory performs tests in the spe-
(B) Must meet one of the following cialty of radiobioassay, the individual
requirements: functioning as the technical supervisor
(1) Be certified in anatomic pathol- must—
ogy by the American Board of Pathol- (1)(i) Be a doctor of medicine or a
ogy or the American Osteopathic Board doctor of osteopathy licensed to prac-
of Pathology or possess qualifications tice medicine or osteopathy in the
that are equivalent to those required State in which the laboratory is lo-
for such certification; or cated; and
(2) Be certified by the American (ii) Be certified in clinical pathology
Board of Ophthalmology or possess by the American Board of Pathology or
qualifications that are equivalent to the American Osteopathic Board of Pa-
those required for such certitication thology or possess qualifications that
and have successfully completed at are equivalent to those required for
least 1 year of formal post-residency such certification; or

fellowship training in ophthalmic pa- (2)(i) Be a doctor of medicine, doctor
thology; or of osteopathy, or doctor of podiatric
711
§ 493.1449 42 CFR Ch. IV (10–1–17 Edition)
medicine licensed to practice medicine, (ii) Have training or experience that

osteopathy, or podiatry in the State in meets one of the following require-
which the laboratory is located; and ments:
(ii) Have at least 1 year of laboratory (A) Have 4 years of laboratory train-
training or experience, or both, in high ing or experience, or both, within the
complexity testing for the specialty of specialty of histocompatibility; or
radiobioassay; or (B)(1) Have 2 years of laboratory
(3)(i) Have an earned doctoral degree training or experience, or both, in the
in a chemical, physical, biological or specialty of general immunology; and
clinical laboratory science from an ac- (2) Have 2 years of laboratory train-
credited institution; and ing or experience, or both, in the spe-
(ii) Have at least 1 year of laboratory cialty of histocompatibility.
training or experience, or both, in high (p) If the laboratory performs tests in
complexity testing within the spe- the specialty of clinical cytogenetics,
cialty of radiobioassay; or the individual functioning as the tech-
(4)(i) Have earned a master’s degree nical supervisor must—
in a chemical, physical, biological or (1)(i) Be a doctor of medicine, doctor
clinical laboratory science or medical of osteopathy, or doctor of podiatric
technology from an accredited institu- medicine licensed to practice medicine,
tion; and osteopathy, or podiatry in the State in
(ii) Have at least 2 years of labora- which the laboratory is located; and
tory training or experience, or both, in (ii) Have 4 years of training or experi-
high complexity testing for the spe- ence, or both, in genetics, 2 of which
cialty of radiobioassay; or have been in clinical cytogenetics; or
(5)(i) Have earned a bachelor’s degree (2)(i) Hold an earned doctoral degree
in a chemical, physical or biological in a biological science, including bio-
science or medical technology from an chemistry, or clinical laboratory
science from an accredited institution;
accredited institution; and
and
(ii) Have at least 4 years of labora-
(ii) Have 4 years of training or experi-
tory training or experience, or both, in
ence, or both, in genetics, 2 of which
high complexity testing for the spe-
have been in clinical cytogenetics.
cialty of radiobioassay.
(q) If the requirements of paragraph
(o) If the laboratory performs tests in
(b) of this section are not met and the
the specialty of histocompatibility, the laboratory performs tests in the spe-
individual functioning as the technical cialty of immunohematology, the indi-
supervisor must either— vidual functioning as the technical su-
(1)(i) Be a doctor of medicine, doctor pervisor must—
of osteopathy, or doctor of podiatric (1)(i) Be a doctor of medicine or a
medicine licensed to practice medicine, doctor of osteopathy licensed to prac-
osteopathy, or podiatry in the State in tice medicine or osteopathy in the
which the laboratory is located; and State in which the laboratory is lo-
(ii) Have training or experience that cated; and
meets one of the following require- (ii) Be certified in clinical pathology
ments: by the American Board of Pathology or
(A) Have 4 years of laboratory train- the American Osteopathic Board of Pa-
ing or experience, or both, within the thology or possess qualifications that
specialty of histocompatibility; or are equivalent to those required for
(B)(1) Have 2 years of laboratory such certification; or
training or experience, or both, in the (2)(i) Be a doctor of medicine, doctor
specialty of general immunology; and of osteopathy, or doctor of podiatric

CFR 2017 Title42a Vol5

Uploaded by

Copyright:

Available Formats

You might also like

CFR 2017 Title42a Vol5

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CFR 2017 Title42a Vol5

Uploaded by

Copyright:

Available Formats

Title 42

Revised as of October 1, 2017

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PUBLISHING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Phone: toll-free (866) 512-1800; DC area (202) 512-1800

Chapter IV—Centers for Medicare & Medicaid Services, Depart-

Chapter V—Office of Inspector General-Health Care, Department

Table of CFR Titles and Chapters ....................................................... 1095

Alphabetical List of Agencies Appearing in the CFR ......................... 1115

List of CFR Sections Affected ............................................................. 1125

To cite the regulations in

CHAPTER IV—Centers for Medicare & Medicaid Services, De-

SUBCHAPTER G—STANDARDS AND CERTIFICATION

505 Establishment of the health care infrastructure

510 Comprehensive care for joint replacement model ... 870

600 Administration, eligibility, essential health bene-

PART 482—CONDITIONS OF 482.56 Condition of participation: Rehabili-

482.54 Condition of participation: Out- 482.100 Condition of participation: Organ

§ 482.12 Condition of participation: (9) Ensure that when telemedicine

medical staff recommendations that lowing requirements are met:

(i) A doctor of medicine or osteop- (C) Limited, under paragraph (c)(1)(v)

that scope is— ital expenditure is for services and fa-

propriate. half of the patient to investigate the

right to be free from restraint or seclu- State law.

of a physician or other licensed inde- (11) Physician and other licensed

criteria specified in paragraph (f) of tient is continually monitored—

behavioral status or condition. straint used on the patient during this

deaths related to restrictions of move- visitation rights, including any clinical

quirements: gency; and continuity of operations, in-

(4) Include a process for cooperation (5) A system of medical documenta-

(ii) Conduct an additional exercise pital may choose to participate in the

(h) The standards incorporated by 16, 2016]

Subpart C—Basic Hospital (i) Focus on high-risk, high-volume,

including the reduction of medical er- through an agreement with a distant-

contained in this section. site telemedicine entity, the governing

from the telemedicine services pro- credentialing, privileging, and over-

including scope-of-practice laws, hos- son where appropriate) to self-admin-

brought into the hospital. trieval by diagnosis and procedure, in

(3) The hospital must have a proce- or by another practitioner responsible

(viii) Final diagnosis with comple- (3) Outdated, mislabeled, or other-

cure area. able, radiologic services according to

that the blood collecting establishment components held in quarantine as set

testing required by FDA is indetermi- riod of 12 weeks unless—

cian or hospital must inform the de- respective duties.

(1) Individual patient nutritional (A) Established by the local medical

(i) A staff committee of the institu- termination that an admission or con-

(2) If application of the Health Care gust 1, 2013.

Discharge planning. hospital that a patient needs a dis-

disclosable financial interest, as speci- eyes or to decline to donate. The indi-

be an organ procurement representa- Subpart D—Optional Hospital

partment when requested by the Sec-

(ii) An updated examination of the (5) An anesthesiologist’s assistant, as

operating practitioner or of an anes- out is consistent with State law.

(ii) All practitioners not appointed to therapy assistants, speech-language pa-