Regulations / Accreditations and Legislations

Laboratory Regulations and their Significance
1983 Prospective Payment System for Medicare
patients established payment based on diagnosis-related
groups (DRGs). Hospitals are paid a fixed amount per
DRG, regardless of actual cost, thereby creating an
incentive to discharge patients as soon as medically
possible. For inpatients, laboratories become cost centers
instead of revenue centers (Social Security Amendments
(P.L. 98-21).
1984 Deflect Reduction Act (P.L. 93-369): Established
outpatient laboratory fee schedule to control cost; froze
Part B fee schedule
1988 Clinical Laboratory Improvement Act of 1988
(CLIA ‘88) (amended 1990, 1992): Established that all
laboratories must be certified by the federal government
with mandated quality assurance, personnel, and
proficiency testing standards based on test complexity.
Until this time, the federal government regulated only the
few laboratories conducting interstate commerce or
independent or hospital laboratories that wanted medicare
reimbursement. CLIA applies to all sites where testing is
done, including physicians’ offices and clinics.
1989 Physicain Self-referral Ban Stark I; PL 101-
239): Prevents physicians from referring Medicare
patients to self-owned laboratories.
Ergonomic Safety and Health Program
Management Guidelines: Established OSHA guidelines
for employee safety
1990 Three-Day Rule initiated by CMS: Payment for any
laboratory testing done 3 calendar days before admission
as in patient is not reimbursed because testing is
considered to be part of the hospital stay (Omnibus
Reconciliation Act); directs HHS to develop an outpatient
DRG system.
Occupational Exposure to Hazardous
Chemicals in Laboratories: Establishes OSHA
guidelines to limit unnecessary exposure to hazardous
chemicals.
1992 Occupational Exposure to Blood-Borne
Pathogens: Established OSHA guidelines to limit
unnecessary exposure to biological hazards.
1996 Health Insurance Portability and
Accountability Act: Directs how health care information
is managed. This law protects patients from inappropriate
dispersion (oral, written, or electronic) of personal
information and is the basis for many of the privacy
standards currently in place.
1997 OIG Compliance Guidelines for clinical
laboratories develop programs that promote high ethical
and lawful conduct, especially regarding billing practices
and fraud and abuse.
2001 CMS National Coverage Determination:
Replaced most local medical review policies used to
determine whether certain laboratory tests are medically
necessary and therefore reimbursable. Before this, each
Medicare intermediary had its own medical necessity
guidelines.
2003 Hazardous Material Regulations: Deal with
shipment of blood and other potentially biohazardous
products (DOT).

Laboratory-Related Government Agencies

CDC Centers for Disease Control and Prevention is under the U.S Department of Health and Human Services
(HHS) and provides oversight of public health and safety, including the laboratory. (www.cdc.gov)
CMS Centers for Medicine and Medical Services (formerly known as GCFA) overseas the largest health care
program in the United States, processing more that 1 billion claims per year. Medicine (see chapter 12)
provides coverage to approximately 40 million Americans over the age of 65, some people with disabilities,
and patients with end-stage stage renal disease, with a budget of 309 billion (2004). Medicaid provides
coverage to approximately 50 million low-income individuals through a stage-federal partnership that cost
277 billion (2004). CMS sets quality standards and reimbursement rates that apply to the laboratory and
are often used by other third-party payers. (www.cms.hhs.gov)
DOT U.S. Department of Transportation has the responsibility of regulating biohazardous materials that
include blood and other human products. Laboratory shipments sent to reference laboratories must be
packaged per guidelines set by this agency. (www.dot.gov)
EPA Environmental Protection Agency sets and enforce standards for disposal of hazardous laboratory
materials such as formalin, xylene and other potential carcinogens. (www.epa.gov)
EEOC Equal Equipment Opportunity Commission oversees and enforces Title VII dealing with fair
employment practices related to the Civil Rights Act of 1964 and the Equal Employment Opportunity Act
of 1972. Hiring of laboratory staff falls under the same rules as most businesses. (www.eeoc.gov)
FDA U.S. Food and Drug Administration is part of HHS and regulates the manufacture of biologics (such as
blood donor testing and component preparation) and medical devices (such as laboratory analyzer) and test
kits through its Office of In-Vitro Diagnostic Device and Safety. FDA inspects blood donor and/or
component manufacturing facilities irrespective of other regulatory agencies and/or accrediting
organization. (www.fda.fov)
HHS U.S Department of Health and Human Services oversees CMS, OIG and FDA
NARA National Archives and Records Administration provides a number of databases, including access to the
Federal Register, where laboratory and other regulations are published
(www.gpoaccess.gov/fr/index.html)
NRC National Regulatory Commission develops and enforces federal guidelines that ensure the proper use
and operation of nonmilitary nuclear facilities. Laboratory tests that uses radioactive materials (like
radioimmunoassay) must adhere to guidelines set by this agency. (www.nrc.gov)
NIDA National Institute on Drug Abuse regulates standards for performing and maintaining appropriate quality
control for drugs of abuse testing (www.nida.gov)
NIOSH National Institutes of Occupational Safety and Health is a part of HHS and provides research,
information, education and training in the field of occupational safety and health. NIOSH makes
recommendations regarding safety hazards but has no authority to enforce them
(www.cdc.gov/niosh/homepage.html)
NIH National Institutes of Health is an agency of HHS and is a world leader in medical research. It publishes
a variety of clinical practice guidelines, some of which are applicable to the laboratory, such as those for
diabetes and lipid testing. (www.nih.gov)
NIST National Institutes of Standards and Technology is a branch of the Commerce Department and has
contributed to the development of many health care products. In addition, it has developed standards for
calibration, weights and measures and the International System of Units. (ww.nist.gov)
OIG Office of the Inspector General is a part of HHS and is responsible for auditing, inspecting and identifying
fraud and abuse in CMS programs such as laboratory testing. The focus of OIG is usually noncompliance
with reimbursement regulations such as medical necessity. (www.oig.hhs.gov)
OSHA Occupational Safety and Health Administration is part of the U.S Department of Labor and develops
and enforces workplace standards to protect employee’s safety and health. Recommendations from OSHA
includes guidelines addressing blood-borne pathogens, chemical safety, phlebotomist, latex gloves,
ergonomics, and any other potentially hazardous situation that may be found in the workplace.
(www.osha.gov)
State State Department of Health vary in the extent to which they regulate laboratories. Some states, like New
Department York license all laboratories and oversees mandatory proficiency testing and laboratory inspection
of Health programs; others do neither. New York and Washington have Clinical Laboratory Improvement Act
“deemed status”

Suggested Guidelines for the Record and Specimens Retention 24 hours urine
Based on College of American Pathologists. CLAA 1988. CLIA 7 days blood and fluid smears
’88 Guidelines 7 days microbiology stains, slides
2 years Retention of records 2 weeks Wet tissue
2 years Accession of logs 10 years surgical pathologist slides (bone marrow)
2 years Maintenance of instrument logs 10 years paraffin block slides
2 years Quality control record 5 years cytology slides
10 years Blood bank donor receipt records 10 years ____-A slides
10 years Blood bank patient records 10 years reports on surgical, cytology, forensics
10 years Blood bank employee signature-initials cytogenetics slides
5 years Blood bank quality control (QC) records 3 years cytogenetics slides
2 years clinical pathology test records 20 years cytogenetics slides reports and images
48 hours Serum, CSF, other body fluids 10 years Flow cytometry plots or histograms
 Licensure on the Operation, Maintenance and
Registration of Clinical Lab in the Philippines
1. RA. 4688 – Approved June 18, 1966
• Section 1: registration and license
o What are the exemptions?
• Section 2: professionally in-charge, licensed
physician
• Section 3: enforcement of the provision –
Secretary of Health through BRL
• Section 4: punishment for violators
• Section 5: if any section or part of this act shall
be adjudged by nay court of competent
jurisdiction to be invalid, the judgement shall not
affect impair or invalidate
• Section 6: The sum of fifty thousand pesos or so
much thereof as maybe necessary
• Section 7: Repealing cause
• Section 8: Approval
2. AO NO. 59 s. 2001
• November 19, 2001
• ADMINISTRATIVE ORDER
• No. 59 series 2001
Rules and regulation governing the
establishment, operation and maintenance of clinical
laboratories in the Philippines
• Section 1
Title:
This Administrative Order shall be known as the “Rules
and Regulations Governing the Establishment, Operation
and Maintenance of Clinical Laboratories in the
Philippines.”
• Section 2: Authority
These rules and regulations are issued to implement R.A.
4688: Clinical Laboratory Law consistent with E.O. 102
series 1999: Redirecting the Functions and Operations of
the Department of Health. The Department of Health
(DOH), through the Bureau of Health Facilities and
Services (BHFS) in the Health Regulation Cluster, shall
exercise the regulatory functions under these rules and
regulations.
• Section 3: Purpose
These rules and regulations are promulgated to protect
and promote the health of the people by ensuring
availability of clinical laboratories that are properly
managed with adequate resources, with effective and
efficient performance through compliance with quality
standards.
• Section 4: Scope
1. These regulations shall apply to all entities performing
the activities and functions of clinical laboratories which
shall include the examination and analysis of any or all
samples of human and other related tissues, fluids,
secretions, radioactive, or other materials from the human
body for the determination of the existence of pathogenic
organisms, pathologic processes or conditions in the
person from whom such samples are obtained.
2. These regulations do not include government
laboratories doing laboratory examinations limited to acid
fast bacilli microscopy, malaria screening and cervical
cancer screening, provided their services are declared as
extension of a licensed government clinical laboratory.
• Section 5: Classification of Laboratories
• Section 6 Policies
1. An approved permit to construct and design lay–out of
a clinical laboratory shall be secured form the BHFS prior
to submission of an application for a Petition to Operate.
2. No clinical laboratory shall be constructed unless plans
have been approved and construction permit issued by the
BHFS.
3. A clinical laboratory shall operate with a valid license
issued by BHFS/CHD, based on compliance with the
minimum licensing requirements (Annex A).
4. The clinical laboratory shall be organized and managed
to provide effective and efficient laboratory services.
5. The clinical laboratory shall provide adequate and
appropriate safety practices for its personnel and clientele.
• Section 7: Requirement and procedures for
Application of Permit
• Section 8: Violations
• Section 9: Investigation of Charges and
Complaints
• Section 10: Modification and Revocation of
License
• Section 11: Repealing cause
• Section 12: Publication and List of Licensed
Clinical Laboratories
• Section 13: Effectivity
AO NO. 59 s. 2001 ANNEX
Technical standards and minimum requirements:
I. Staffing:
1) shall be managed by Pathologist or
Physician with three months training on
clinical laboratory medicine, quality
control and lab management
2) shall Staffing employ qualified and
adequately trained personnel
3) number of medical technologists shall be
proportional to the workload and shall be
available at all times
4) there shall be staff development and
appropriate continuing education
II. Physical Facilities:
1) well ventilated
2) sufficient working space and adequate
water supply
3) shall have the following measurements
• Category: space / sq meter
• Primary: 10
• Secondary: 20
• Tertiary: 60
III. Equipment/Instruments
1) there shall be provisions for sufficient
number and types of appropriate
equipment/instruments
2) for other lab examinations, equipment
necessary for performing procedures
shall be made available
IV. Glasswares / Reagents / Supplies
• All categories of clinical laboratories
shall provide adequate and appropriate
glassware, reagents and supplies
necessary to undertake the required
services.
V. Waste Management
• There shall be provisions for adequate and
efficient disposal of waste following
guidelines of the DOH and the LGU
VI. Quality Control Program
1) Internal Quality Control Program
- documented continuous competency
assessment program for all lab personnel
- the program shall provide appropriate
and standard lab methods, reagents and
supplies and equipment
- program for the proper monitoring and
maintenance of all equipment
- program for the use of quality control
reference materials
2) External Quality Control Program
- shall participate in an External Quality
Assurance Program
- satisfactory performance rating
- non participation – basis for the
suspension/revocation of the license
VII. Reporting
• All lab reports shall bear the name of the
registered medical technologist and
pathologist
• No person shall issue a report, orally or in
writing without the directive from the
Pathologist or his authorized associate to the
requesting physician or his authorized
representative except in emergency cases
VIII. Recording
1) adequate and effective system of recording
requests and reports of all specimens
submitted and examined
2) provisions for filling storage and accession of
all reports
3) lab records shall be kept or file for at least 1
year.
Anatomic and forensic pathology:
permanently
IX. Laboratory Fees
1) rates shall be within range, take in to
consideration the cost of testing and quality
control of laboratory procedures
2) performance of special procedures or
examinations shall ne charged separately
Sections of The Clinical Laboratory
I. Clinical Chemistry
- testing of blood and other body fluids to quantify
essential soluble chemicals including waste
products useful for the diagnosis of a certain
diseases
- blood and urine most common
- one of the busiest, state of the art full automated
facility
- Endocrinology: testing of hormones
- Toxicology and Drug testing
- IQA, NEQAP and CQI important activities
II. Microbiology
4 sections
1) bacteriology
2) mycobacteriology
 3) mycology
4) virology
- specimen: blood and other body fluids, stool
swabs from different sites of the body
Activities in Microbiology section
1. microscopic visualization of microorganisms after
staining, isolation and identification of bacteria
(aerobes and anaerobes) and fungi
2. antibacterial. Antimicrobial susceptibility testing
3. preparation of culture media and stains
4. quality control and quality assurance
5. infection control and biosafety
6. proper waste disposal
7. mycobacteriology for identification
mycobacterium
III. Hematology and Coagulation Studies
- Enumeration of cells in the blood and other
body fluids
- Examinations done include: CBC, blood smear
preparation and staining of body fluids
- Coagulation studies
- Automated machines: Automated hematology
analyzers
- Bone marrow examination
IV. Clinical Microscopy
1) Macroscopic examinations
- Color
- Transparency
- Chemical properties
2) Microscopic examinations
- To detect presence of abnormal cells and
parasites
- To quantify red cells and WBC
- To check on the presence of other
chemicals found in urine
V. Blood Bank/Immunohematology
Main activities:
1) blood typing
2) compatibility testing
3) screening for all antibodies
4) identification of antibodies
5) screening of blood components used for
blood transfusion
6) (HBL) – blood donation activities such as
donor recruitment and screening, bleeding
donor and post- donation care
VI. Immunology and Serology
- Analysis of serum antibodies in certain
infectious agents (primarily of viral origin)
- Immunology is the study of the body's
immune system and its functions and
disorders. Serology is the study of blood
serum (the clear fluid that separates when
blood clots).
Immunology and serology laboratories focus on the
following:
- Identifying antibodies. These are proteins
made by a type of white blood cell in response
to a foreign substance (antigen) in the body.
of - Investigating problems with the immune
system. These include when the body's
immune system attacks its own tissues
(autoimmune diseases) and when a body's
immune system is underactive
(immunodeficiency disorders).
- Determining organ, tissue, and fluid
compatibility for transplantation
ANATOMIC PATHOLOGY
- Section of Histopathology/Cytology
SPECIALIZED SECTIONS OF THE LABORATORY
- Immunohistochemistry
- Molecular biology and biotechnology
Laboratory Testing Cycle
Three Phases of Laboratory Cycle
1. PRE- ANALYTIC PHASE
2. ANALYTIC PHASE
3. POST- ANALYTIC PHASE
Quality Assurance in the Clinical Laboratory
• TO ensure reliability of test results
• Organized, systematic, well- planned and
regularly done with results for documentation and
review
 2 MAJOR COMPONENTS
1. IQAS day to day activities
2. EQAS system for checking
performance among clinical
laboratories, facilitated by
external agencies
NRL

Designated NRL- EQAS are the following:

1. National Kidney Transplant Institute (NKTI) –
Hematology and Coagulation
2. Research Institute of Tropical Medicine
(RITM) – Microbiology (identification and
antibiotic susceptibility testing) and Parasitology
(identification of ova and quantitation of malaria)
3. Lung Center of the Philippine (LCP) – Clinical
Chemistry (for testing 10 analytes, namely
glucose, creatinine, total protein, albumin, blood
urea nitrogen, uric acid, cholesterol, sodium,
potassium, and chloride)
4. East Avenue Medical Center (EAMC) – drugs
of abuse (methamphetamine and cannabinoids
5. San Lazaro Hospital STD-AIDS Cooperative
Center Laboratory (SACCL) – infectious
immunology hepatitis B surface antigen (HBsAg),
human immunodeficiency virus (HIV), hepatitis
C virus (HCV)