Instructions for Completing the PACE Program Self - Assessment Tool

Overview

Purpose The attached self-assessment tool was developed to assist PACE organizations in assessing their readiness for pending CMS audits. Please note, the tool is not a predictor of success with the CMS audit
evaluation, but rather, intended to prompt organizations to consider certain key questions when self-evaluating operational processes, policies and procedures and clinical practices.

The self-assessment tool was designed to mirror the audit elements reviewed (and the order in which they appear) during a CMS audit. PACE organizations can enter information in the designated
assessment fields; however, to maintain the integrity of the tool, all other fields have been protected and cannot be altered or deleted.

Sections of the Self - Assessment Tool

In addition to the instructions tab, there are five (5) tabs that comprise the self-assessment tool:
1. Clinical Elements
2. Administrative Element
3. AdHoc Elements
4. Clarifications
5. Met with Notes

Clinical, Administrative and Ad Hoc Element Tabs

Sections The Clinical, Administrative and Ad Hoc element tabs contain the following fields:

Element Title: The element title and the corresponding PACE federal regulation number begin each section within the Clinical, Administrative and Ad Hoc tabs.

Requirement: A summary of the PACE federal requirement can be found in the purple field directly below the Element Title.

Owner/Lead: The individual within the PACE organization responsible for directing and/or managing the performance standard and ensuring successful monitoring should be identified in this field of the
tool.

Info Source: Includes examples of documentation or evidence that can be used to demonstrate compliance. The intent is not to be prescriptive but to provide guidance.  Sources include but are not limited
to: documented processes, grids, charts, surveys, reports or records/files.

Key Points: Important takeaways and/or reminders for the element section.

Element Questions: Each element section includes a group of questions which address specific areas of focus within the regulations. Organizations should select an answer for each question, either yes
or no, using the drop down box to the right of the question.

Met/Not Met: After answering the element questions, PACE organizations will be able to self-assess their overall performance against the element by using the drop-down box within the field and selecting
one of the two options -- Met or Not Met. Please note, by selecting Met, the PACE organization must be able to demonstrate compliance through some form of written documentation (i.e., policies, logs,
agreements, records, etc.).

Met with Note: PACE organizations can select the link and enter any additional information or notation in this field.

Helpful Features

Clarifications Tab and Hyperlink

Some element questions may require additional information or an explanation addressing element question and its intent. Such questions will have a hyperlinked "C" and when selected, will take the
organization to the clarification for the corresponding element. To return the Element Tab, select either the element abbreviation to the right or left of the clarification statement. PACE organizations can see
a list of all clarifications by selecting the Clarifications tab the Self-Assessment Tool.

Met with Notes Tab and Hyperlink

PACE organizations may wish to add a comment or additional information for elements scored as Met. By selecting the hyperlink Met with Note, PACE organizations will be able to enter any notes or
comments in the corresponding field. To return to the Element Tab, select the element abbreviation to the right of the note. PACE organizations can also view their list of entered notes by selecting the Met
with Note tab within the Self-Assessment Tool.

ATTENTION: Due to different monitor sizes and screen resolutions, the entire area of the worksheet may not display on your screen. In this case, it will be necessary to
scroll to the RIGHT or reduce the zoom on your monitor in order to capture the entire page on your screen.
PACE Program Self-Assessment Tool
CLINICAL ELEMENTS
Personnel Training (460.66) Clarifi- Owner / Self - Assessment
PRS 02 cation Lead Met / Not Met Met w/Note
Requirement (a) The PACE organization must provide training to maintain and improve the skills and knowledge of each staff member with respect to the individual’s specific duties that results in his or her continued ability to demonstrate the skills necessary for the performance
of the position.
(b) The PACE organization must develop a training program for each personal care attendant to establish the individual’s competency in furnishing personal care services and specialized skills associated with specific care needs of individual participants.
(c) Personal Care attendants must exhibit competency before performing personal care services independently. Add Note

Yes / No
PRS 1 Does your program have a written training manual that is provided to all new employees which includes PACE policies and procedures and knowledge specific duties relative to the position?
PRS 2 Does your program have a written set of initial competencies and/or scope of practice statements for each position that has direct care responsibilities, including licensed professional staff?
(physicians, nurse practitioners, social workers, nurses, physical, occupational, and speech therapists, and mental health professionals)?
PRS 3 Does the competency assessment assess all of the skills required by the position description?
PRS 4 Does the initial scope of practice documents specify how each skill is assessed?
PRS 5 Does your training program describe plans for in-services, methods of teaching and, by whom?
PRS 6 Does your program have an assessment of competencies for all staff within the first year?
PRS 7 Does your program have written plans for staff training to maintain skills and re-assessment of skills, including in-services, training, content, method of teaching and testing, and by whom?
PRS 8 Does your program have a process for annual reassessment of competencies for existing staff? CMS reg states "ongoing" , doesn't have to be annual, but most PO do it annually.
PRS 9 Is the reassessment schedule staggered through the year?
PRS 10 Does your program have a process for maintaining records for licensed professional staff to ensure that all requirements are met for licensure, certification, and continuing professional education?
PRS 11 Do you have a peer review process for assessing the performance of licensed professional staff?
PRS 12 Do you have a process for training staff on HIPAA privacy policies and documenting completion? C
PRS 13 Do you have a program for training personal care attendants (PCAs) and assessing competencies for providing services and specialized skills and documenting completion prior to giving C
direct participant care?
Info Source Position description, PCA training program description, training and assessment tools
Key Points Self assessment skills do not meet the intent of the requirements
Oversight of Direct Patient Care (460.71) Owner / Self - Assessment
PRS 04 Lead Met / Not Met Met w/Note
Requirement (a) The PACE organization must ensure that all employees and contracted staff furnishing care directly to participants demonstrate the skills necessary for performance of their position.
(1) The PACE organization must provide each employee and all contracted staff with an orientation. The orientation must include at a minimum the organization's mission, philosophy, policies on participant rights, emergency plan, ethics, the PACE benefit, and any
policies related to the job duties of specific staff.
(2) The PACE organization must develop a competency evaluation program that identifies those skills, knowledge, and abilities that must be demonstrated by direct participant care staff (employees and contractors).
(3) The competency program must be evidenced as completed before performing participant care and on an ongoing basis by qualified professionals.
(4) The PACE organization must designate a staff member to oversee these activities for employees and work with the PACE contractor liaison to ensure compliance by contracted staff.
(b) The PACE organization must develop a program to ensure that all staff furnishing direct participant care services meet the following requirements:
(1) Comply with any State or Federal requirements for direct patient care staff in their respective settings.
(2) Comply with the requirements of Sec. 460.68(a) regarding persons with criminal convictions.
(3) Have verified current certifications or licenses for their respective positions. Add Note
(4) Are free of communicable diseases and are up to date with immunizations before performing direct patient care.
(5) Have been oriented to the PACE program.
(6) Agree to abide by the philosophy, practices, and protocols of the PACE organization.

Yes / No
PRS 14 Does your program have written policies and procedures for ensuring that all employees and contracted staff providing care directly to participants demonstrate the skills necessary for performance
of the position?
PRS 15 Do your contractor agreements contain language describing your policies and procedures to assure compliance with PACE federal regulation?
PRS 16 Does your program have a systematic orientation for new employees and contracted staff that covers your organization’s mission, philosophy?
PRS 17 Does your program have a systematic orientation for new employees and contracted staff that covers policies on participant rights?
PRS 18 Does your program have a systematic orientation for new employees and contracted staff that covers policies on your emergency plan?
PRS 19 Does your program have a systematic orientation for new employees and contracted staff that covers policies on ethics?
PRS 20 Does your program have a systematic orientation for new employees and contracted staff that covers policies on covered services?
PRS 21 Does your program have a systematic orientation for new employees and contracted staff that covers policies related to roles and responsibilities for the specific position?
PRS 22 Does your program have a process in place for ensuring that existing staff attend an updated orientation on a periodic basis?
PRS 23 Does your program have a process to evaluate competencies and document (skills, knowledge and abilities specific to the position) that must be demonstrated by direct participant care contractors before caring for participants? (this item for employed staff is in the
PRS 24 section above)
Does your program have process by which qualified professionals reevaluate competencies of contracted direct care staff on an annual basis?
PRS 25 Do you have a designated staff member who oversees orientation, competency assessment and training for employees and works closely with the contract liaison to ensure compliance by contracted staff?
PRS 26 Does your program ensure that all staff furnishing direct participant care services are free of communicable diseases?
Info Source Orientation program, criminal background check log/records
Key Points
 Physical Environment (460.72) Owner / Self - Assessment
ENV 01 Lead Met / Not Met Met w/Note
Requirement (a) Space and equipment—
(1) Safe design. A PACE center must meet the following requirements:
(i) Be designed, constructed, equipped, and maintained to provide for the physical safety of participants, personnel, and visitors.
(ii) Ensure a safe, sanitary, functional, accessible, and comfortable environment for the delivery of services that protects the dignity and privacy of the participant.
(2) Primary care clinic. The PACE center must include sufficient suitable space and equipment to provide primary medical care and suitable space for team meetings, treatment, therapeutic recreation, restorative therapies, socialization, personal care, and dining.
(3) Equipment maintenance.
(i) A PACE organization must establish, implement and maintain a written plan to ensure that all equipment is maintained in accordance with the manufacturer's recommendations.
(ii) A PACE organization must perform the manufacturer’s recommended maintenance on all equipment as indicated in the organization’s written plan.
(b) Fire safety—
(1) General rule. Except as otherwise provided in this section--
(i) A PACE center must meet the applicable provisions of the 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association that apply to the type of setting in which the center is located. The Director of the Office of the Federal Register has
approved the NFPA 101 [reg] 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource
Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/code-of--federal--
regulations/ibr--locations.html. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register
to announce the changes.
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to PACE centers.
(2) Exceptions.
(i) The Life Safety Code provisions do not apply in a State in which CMS determines that a fire and safety code imposed by State law adequately protects participants and staff.
(ii) CMS may waive specific provisions of the Life Safety Code that, if rigidly applied, would result in unreasonable hardship on the center, but only if the waiver does not adversely affect the health and safety of the participants and staff.
(3) Beginning March 13, 2006, a PACE center must be in compliance with Chapter 9.2.9, Emergency Lighting.
(4) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to PACE centers.
(5) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a PACE center may install alcohol-based hand rub dispensers in its facility if--
(i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;
(ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately protects against inappropriate access; and
(iv) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued by the Standards Council of the National Fire Protection Add Note
Association on April 15, 2004
(c) Emergency and disaster preparedness—
(1) Procedures. The PACE organization must establish, implement, and maintain documented procedures to manage medical and nonmedical emergencies and disasters that are likely to threaten the health or safety of the participants, staff,
(2) Emergencies defined. Emergencies include, but are not limited, to the following:
(i) Fire.
(ii) Equipment, water, or power failure.
(iii) Care-related emergencies.
(iv) Natural disasters likely to occur in the organization's geographic area. (An organization is not required to develop emergency plans for natural disasters that typically do not affect its geographic location.)
(3) Emergency training. A PACE organization must provide appropriate training and periodic orientation to all staff (employees and contractors) and participants to ensure that staff demonstrate a knowledge of emergency procedures, including informing participants
what to do, where to go, and whom to contact in case of an emergency.
(4) Availability of emergency equipment. Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs, along with staff who know how to use the equipment, must be on the premises of every center at all times and be immediately
available. The organization must have a documented plan to obtain emergency medical assistance from sources outside the center when
needed.
(5) Annual test of emergency and disaster plan. At least annually, a PACE organization must actually test, evaluate and document the effectiveness of its emergency and disaster plans.
or the public(iii) Care-related emergencies.
(iv) Natural disasters likely to occur in the organization's geographic area. (An organization is not required to develop emergency plans for natural disasters that typically do not affect its geographic location.)
(3) Emergency training. A PACE organization must provide appropriate training and periodic orientation to all staff (employees and contractors) and participants to ensure that staff demonstrate a knowledge of emergency procedures, including informing participants
what to do, where to go, and whom to contact in case of an emergency.
(4) Availability of emergency equipment. Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs, along with staff who know how to use the equipment, must be on the premises of every center at all times and be immediately
available. The organization must have a documented plan to obtain emergency medical assistance from sources outside the center when
needed.
(5) Annual test of emergency and disaster plan. At least annually, a PACE organization must actually test, evaluate and document the effectiveness of its emergency and disaster plans.

Yes / No
ENV 1 Is your space designed, constructed, equipped, and maintained to provide for the physical safety of participants, personnel, and visitors?
ENV 2 Does your space ensure a safe, sanitary, functional, accessible, and comfortable environment for the delivery of services that protects the dignity and privacy of the participant?
ENV 3 Does your Center include sufficient suitable space and equipment to provide primary care, team meetings, treatment, therapeutic recreation, restorative therapies, socialization, personal care
and dining?
ENV 4 Have you established, implemented, and maintained a written plan to ensure that all equipment is maintained in accordance with the manufacturer’s recommendations? C
ENV 5 Have you established, implemented, and maintained documented procedures to manage medical and nonmedical emergencies and disasters that are likely to threaten the health or safety
of the participants, staff, or the public?
ENV 6 Do such emergencies include fire, equipment, water, or power failure, care-related emergencies, and natural disasters?
ENV 7 Do you provide appropriate emergency training and periodic orientation to all staff?
ENV 8 Do you have fire extinguishers?
ENV 9 Are your fire extinguishers up to date?
ENV 10 Are your alarms working?
ENV 11 Do your doorways allow easy access for participants?
ENV 12 Are equipment and materials properly stored for participants' safety?
ENV 13 Do you have a plan in place that enusres staff know how to use your equipment and knows what to do with failed equipment? C
ENV 14 Is emergency equipment, including easily portable oxygen, airways, suction and emergency drugs, along with staff who know how to use the equipment, on the premises of every Center at all times and be immediately available?
ENV 15 Do you have a documented plan to obtain emergency medical assistance from sources outside the center when needed?
ENV 16 At least annually, does your organization actually test, evaluate, and document the effectiveness of its emergency and disaster plans?
Info Source Training Policy and Procedures; Life Saftey Code Requirements; Equipment Maintenance Plan; Medical and Non-Medical Emergency Plan Inspection Reports; Maintenance Logs
Key Points
 Infection Control (460.74) Owner / Self - Assessment
ENV 02 Lead Met / Not Met Met w/Note
Requirement (a) Standard procedures. The PACE organization must follow accepted policies and standard procedures with respect to infection control, including at least the standard precautions developed by the Centers for Disease Control and Prevention.
(b) Infection control plan. The PACE organization must establish, implement, and maintain a documented infection control plan that meets the following requirements:
(1) Ensures a safe and sanitary environment.
(2) Prevents and controls the transmission of disease and infection.
(c) Contents of infection control plan. The infection control plan must include, but is not limited to, the following:
(1) Procedures to identify, investigate, control, and prevent infections in every center and in each participant's place of residence.
(2) Procedures to record any incidents of infection. Add Note
(3) Procedures to analyze the incidents of infection to identify trends and develop corrective actions related to the reduction of future incidents.

Yes / No
ENV 17 Does your infection control plan include procedures to define staff and participant infections?
ENV 18 Does your infection control plan include procedures to identify, investigate, control and prevent infections in every center and participant’s place of residence?
ENV 19 Does your infection control plan include procedures to identify participants with a high risk of infection?
ENV 20 Does your infection control plan include procedures to record incidents of specified types of infection?
ENV 21 Can you provide a log of reported incidents?
ENV 22 Does your infection control plan include procedures to analyze reported incidents of infection to identify trends and develop corrective actions to reduce future incidents?
ENV 23 Can you provide documentation to verify that appropriate immunizations have been offered, declinations have been documented where applicable, and that tuberculin testing has been offered based
on exposure risk determined by the program?
ENV 24 Does the refrigerator where lab specimens are stored have a universal biohazard label?
ENV 25 Is personal protective equipment available in the immediate area where participants are bathed and showered?
ENV 26 Are medications and immunizations stored at temperatures per manufacturer’s guidelines?
ENV 27 Do you have procedures in place for routine monitoring of refrigerator/freezer temperature for vaccine and medication storage?
ENV 28 Do you have a process by which outliers measurements are reported and addressed?
ENV 29 Is there an audit process to ensure adherence to these procedures?
ENV 30 Do you have procedures for mandatory reporting of communicable diseases to the appropriate state and local officials?
ENV 31 Do you have a written OSHA Exposure Control Plan which includes the Standard Precautions and Bloodborne Pathogens exposure procedures, training and record keeping for staff
(including contractors and volunteers)?
Info Source Infection Control Policy and Procedures, infection control logs
Key Points
Transportation Services (460.76) Owner / Self - Assessment
TRS 01 Lead Met / Not Met Met w/Note
Requirement (a) Safety, accessibility, and equipment. A PACE organization’s transportation services must be safe, accessible, and equipped to meet the needs of the participant population.
(b) Maintenance of vehicles
(1) If the PACE organization owns, rents, or leases transportation vehicles, it must maintain these vehicles in accordance with the manufacturer’s recommendations.
(2) If a contractor provides transportation services, the PACE organization must ensure that the vehicles are maintained in accordance with the manufacturer’s recommendations.
(c) Communication with PACE center. The PACE organization must ensure that transportation vehicles are equipped to communicate with the PACE center.
(d) Training. The PACE organization must train all transportation personnel (employees and contractors) in the following:
(1) Managing the special needs of participants.
(2) Handling emergency situations. Add Note
(e) Changes in care plan. As part of the interdisciplinary team process, PACE organization staff (employees and contractors) must communicate relevant changes in a participant’s care plan to transportation personnel.

Yes / No
TRS 1 Are your vehicles equipped to communicate with Center? C
TRS 2 Is your transportation personnel trained to manage special needs of participants and handle emergency situations?
TRS 3 Do you ensure staff (employees and contractors) communicate relevant changes to the participant’s POC to transportation personnel?
Info Source Training policy; vehicle inspection log, driver's license of transportation staff
Key Points
 Dietary Services (460.78) Owner / Self - Assessment
DTY 01 Lead Met / Not Met Met w/Note
Requirement (a) Meal requirements.
(1) Except as specified in paragraphs (a)(2) or (a)(3) of this section, the PACE organization must ensure, through the assessment and care planning process, that each participant receives nourishing, palatable, well-balanced meals that meet the participant’s daily
nutritional and special dietary needs.Each meal must meet the following requirements:
(i) Be prepared by methods that conserve nutritive value, flavor, and appearance.
(ii) Be prepared in a form designed to meet individual needs.
(iii) Be prepared and served at the proper temperature.
(2) The PACE organization must provide substitute foods or nutritional supplements that meet the daily nutritional and special dietary needs of any participant who has any of the following problems:
(i) Refuses the food served.
(ii) Cannot tolerate the food served.
(iii) Does not eat adequately.
(3) The PACE organization must provide nutrition support to meet the daily nutritional needs of a participant, if indicated by his or her medical condition or diagnosis. Nutrition support consists of tube feedings, total parenteral nutrition, or peripheral parenteral
nutrition. Add Note
(b) Sanitary conditions. The PACE organization must do the following:
(1) Procure foods (including nutritional supplements and nutrition support items) from sources approved, or considered satisfactory, by Federal, State, Tribal, or local authorities with jurisdiction over the service area of the organization.
(2) Store, prepare, distribute, and serve foods (including nutritional supplements and nutrition support items) under sanitary conditions.(3) Dispose of garbage and refuse properly.

Yes / No
DTY 1 Do you have a dietary policy and procedure? C
DTY 2 Is each meal prepared and served at the proper temperature?
DTY 3 Do you have a process for substituting foods for any participant who refuses the food served?
DTY 4 Do you have a process for substituting foods for any participant who cannot tolerate the food served?
DTY 5 Do you have a process for substituting foods for any participant who does not eat adequately?
DTY 6 Do you provide nutritional support in the way of tube feedings, total parenteral nutrition, or peripheral parenteral nutrition?
DTY 7 Is your food procured from satisfactory/approved sources and stored, prepared, distributed, served and disposed under sanitary conditions?
DTY 8 Is your dishwasher reaching appropriate temperatures?
DTY 9 Are your sanitation sinks being tested regularly?
Info Source Statement of Rights and Responsibilities, Marketing materials, criteria used to determine participant attendance test log, dietary service policy
Key Points
Service Delivery (460.98) Owner / Self - Assessment
SDY 01 Lead Met / Not Met Met w/Note
Requirement (a) Plan. A PACE organization must establish and implement a written plan to furnish care that meets the needs of each participant in all care settings 24 hours a day, every day of the year.
(b) Provision of services.
(1) The PACE organization must furnish comprehensive medical, health, and social services that integrate acute and long-term care.
(2) These services must be furnished in at least the PACE center, the home, and inpatient facilities.
(3) The PACE organization may not discriminate against any participant in the delivery of required PACE services based on race, ethnicity, national origin, religion, sex, age, sexual orientation, mental or physical disability, or source of payment. (c) Minimum
services furnished at each PACE center. At a minimum, the following services must be furnished at each PACE center:
(1) Primary care, including physician and nursing services.
(2) Social services.
(3) Restorative therapies, including physical therapy and occupational therapy.
(4) Personal care and supportive services.
(5) Nutritional counseling.
(6) Recreational therapy.
(7) Meals. Add Note
(d) Center operation. (1) A PACE organization must operate at least one PACE center either in, or contiguous to, its defined service area with sufficient capacity to allow routine attendance by participants.
(2) A PACE organization must ensure accessible and adequate services to meet the needs of its participants. If necessary, a PACE organization must increase the number of PACE centers, staff, or other PACE services.
(3) If a PACE organization operates more than one center, each center must offer the full range of services and have sufficient staff to meet the needs of participants.
(e) Center attendance. The frequency of a participant's attendance at a center is determined by the interdisciplinary team, based on the needs and preferences of each participant.

Yes / No
SDY 1 Do you provide the minimum services at each of your centers: primary care, social services, restorative therapies, personal care, nutritional counseling, recreational therapy and meals?
SDY 2 Do you ensure you have sufficient staffing to provide all necessary services?
SDY 3 Do you ensure that the participant’s ADHC attendance is based on individuals’ needs and preferences? If no, describe criteria .
SDY 4 Do you have a formal process for tracking participant's attendance at a Center as determined by IDT?
SDY 5 Do you ensure care in all settings (care coordination) 24 hours a day, every day of the year?
Info Source Organization description, care plans, marketing materials
Key Points The PACE policy can specify assessment tools for use by PACE providers; however, a particular tool is not mandated.
 Emergency Care (460.100) Owner / Self - Assessment
SDY 02 Lead Met / Not Met Met w/Note
Requirement a) Written plan. A PACE organization must establish and maintain a written plan to handle emergency care. The plan must ensure that CMS, the State, and PACE participants are held harmless if the PACE organization does not pay for emergency services.
(b) Emergency care. Emergency care is appropriate when services are needed immediately because of an injury or sudden illness and the time required to reach the PACE organization or one of its contract providers, would cause risk of permanent damage to the
participant's health. Emergency services include inpatient and outpatient services that meet the following requirements:
(1) Are furnished by a qualified emergency services provider, other than the PACE organization or one of its contract providers, either in or out of the PACE organization's service area.
(2) Are needed to evaluate or stabilize an emergency medical condition.
(c) An emergency medical condition means a condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of
immediate medical attention to result in the following:
(1) Serious jeopardy to the health of the participant.
(2) Serious impairment to bodily functions.
(3) Serious dysfunction of any bodily organ or part.
(d) Explanation to participant. The organization must ensure that the participant or caregiver, or both, understand when and how to get access to emergency services and that no prior authorization is needed.
(d) On-call providers. The plan must provide for the following:
(1) An on-call provider, available 24-hours per day to address participant questions about emergency services and respond to requests for authorization of urgently needed out-of-network services and post stabilization
care services following emergency services.
(2) Coverage of urgently needed out-of-network and post-stabilization care services when either of the following conditions are met:
(i) The services are preapproved by the PACE organization.
(ii) The services are not preapproved by the PACE organization because the PACE organization did not respond to a request for approval within 1 hour after being contacted or cannot be contacted for approval.
(3)Definitions. As used in this section, the following definitions apply: Add Note
(i) Post stabilization care means services provided subsequent to an emergency that a treating physician views as medically necessary after an emergency medical condition has been stabilized. They are not emergency
services, which PACE Organizations are obligated to cover. Rather they are non-emergency services that the PO should approve before they are provided outside the service area.
(ii) Urgent care means the care provided to a PACE participant who is out of the PACE service area and who believes their illness or injury is too severe to postpone treatment until they return to the service area, but their life or function is not in severe jeopardy.

Yes / No
SDY 6 Do you have written policies for handling emergency care that include on-call provider 24/7 to address questions and respond to requests for authorization to urgent or post-stabilization care? C
SDY 7 Do you have written policies for handling emergency care that include coverage of urgently needed out-of-network and post-stabilization services for when services have been pre-approved or when services have not been pre-approved due to failure of PACE staff C
SDY 8 to respond
Does within 1 hour
your program of initial
ensure contact? caregiver or both understand when and how to access emergency services?
that participant,
SDY 9 Do you have a mechanism to review reasons for emergency department visits and initiate process improvements if indicated?
SDY 10 Do you ensure that the participant’s ADHC attendance is based on individuals’ needs and preferences? If no, describe criteria .
Info Source Participant Rights, Brochures, Agreements, Handbooks
Key Points
 Owner /
Interdisciplinary Team (460.102) Lead Self - Assessment
SDY 03
Requirement (a) Basic requirement. A PACE organization must meet the following requirements:
(1) Establish an interdisciplinary team at each center to comprehensively assess and meet the individual needs of each participant.
(2) Assign each participant to an interdisciplinary team functioning at the PACE center that the participant attends.
(b) Composition of interdisciplinary team. The interdisciplinary team must be composed of at least the following members:
(1) Primary care physician.
(2) Registered nurse.
(3) Master’s-level social worker.
(4) Physical therapist.
(5) Occupational therapist.
(6) Recreational therapist or activity coordinator.
(7) Dietitian.
(8) PACE center manager.
(9) Home care coordinator.
(10) Personal care attendant or his or her representative.
(11) Driver or his or her representative.
(c) Primary care physician.
(1) Primary medical care must be furnished to a participant by a PACE primary care physician.
(2) Each primary care physician is responsible for the following:
(i) Managing a participant's medical situations.
(ii) Overseeing a participant's use of medical specialists and inpatient care. Add Note
(d) Responsibilities of interdisciplinary team.
(1) The interdisciplinary team is responsible for the initial assessment, periodic reassessments, plan of care, and coordination of 24 hour care delivery.
(2) Each team member is responsible for the following:
(i) Regularly informing the interdisciplinary team of the medical, functional, and psychosocial condition of each participant.
(ii) Remaining alert to pertinent input from other team members, participants, and caregivers.
(iii) Documenting changes of a participant's condition in the participant's medical record consistent with documentation policies established by the medical director.
(3) The members of the interdisciplinary team must serve primarily PACE participants.
(e) Exchange of information between team members. The PACE organization must establish, implement, and maintain documented internal procedures governing the exchange of information between team members, contractors, and participants and their
caregivers consistent with the
requirements for confidentiality in Sec.460.200(e).

Yes / No
SDY 11 Does the IDT plan of care address all dimensions that effect the participant’s health and well-being?
SDY 12 Do you evaluate the operations and function of the IDT? If so, how?
SDY 13 Do you have continuity in team facilitation?
SDY 14 Are IDT decisions consistently documented in the Medical Record?
SDY 15 Do you have a documented process for assigning each participant to an IDT?
Info Source Policies and Procedures, Position Description, Confidentiality Procedures, IDT Meeting Minutes, Medical Records
Key Points CMS is looking for evidence of coordination of care
 Participant Assessment (460.104) Owner / Self - Assessment
SDY 04 Lead Met / Not Met Met w/Note
Requirement (a) Initial comprehensive assessment— (1) Basic requirement. The interdisciplinary team must conduct an initial comprehensive assessment on each participant. The assessment must be completed promptly following enrollment.
(2) As part of the initial comprehensive assessment, each of the following members of the interdisciplinary team must evaluate the participant in person, at appropriate intervals, and develop a discipline-specific assessment of the participant's health and social
status:
(i) Primary care physician.
(ii) Registered nurse.
(iii) Master’s-level social worker.
(iv) Physical therapist.
(v) Occupational therapist.
(vi) Recreational therapist or activity coordinator.
(vii) Dietitian.
(viii) Home care coordinator.
(3) At the recommendation of individual team members, other professional disciplines (for example, speech-language pathology, dentistry, or audiology) may be included in the comprehensive assessment process.
(4) Comprehensive assessment criteria. The comprehensive assessment must include, but is not limited to, the following:
(i) Physical and cognitive function and ability.
(ii) Medication use.
(iii) Participant and caregiver preferences for care.
(iv) Socialization and availability of family support.
(v) Current health status and treatment needs.
(vi) Nutritional status.
(vii) Home environment, including home access and egress.
(viii) Participant behavior.
(ix) Psychosocial status.
(x) Medical and dental status.
(xi) Participant language.
(b) Development of plan of care. The interdisciplinary team must promptly consolidate discipline specific assessments into a single plan
of care for each participant through discussion in team meetings and consensus of the entire interdisciplinary team. In developing the plan of care, female participants must be informed that they are entitled to choose a qualified specialist for women's health
services from the PACE organization's network to furnish routine or preventive women's health services.

Add Note
 (c) Periodic reassessment— (1) Semiannual reassessment. On at least a semiannual basis, or more often if a participant's condition dictates, the following members of the interdisciplinary team must conduct an in-person reassessment:
(i) Primary care physician.
(ii) Registered nurse.
(iii) Master’s-level social worker.
(iv) Recreational therapist or activity coordinator.
(v) Other team members actively involved in the development or implementation of the participant's plan of care, for example, home care coordinator, physical therapist, occupational therapist, or dietitian.
(2) Annual reassessment. On at least an annual basis, the following members of the interdisciplinary team must conduct an in-person reassessment:
(i) Physical therapist.
(ii) Occupational therapist.
(iii) Dietitian. Add Note
(iv) Home care coordinator.
(d) Unscheduled reassessments. In addition to annual and semiannual reassessments, unscheduled reassessments may be required based on the following:
(1) A change in participant status. If the health or psychosocial status of a participant changes, the members of the interdisciplinary team,
listed in paragraph (a)(2) of this section, must conduct an in-person reassessment.
(2) At the request of the participant or designated representative. If a participant (or his or her designated representative) believes that the participant needs to initiate, eliminate, or continue a particular service, the appropriate members of the interdisciplinary team,
as identified by the
interdisciplinary team, must conduct an in-person reassessment.
(i) The PACE organization must have explicit procedures for timely resolution of requests by a participant or his or her designated representative to initiate, eliminate or continue a particular service.
(ii) Except as provided in paragraph (c)(3)(iii) of this section, the interdisciplinary team must notify the participant or designated representative of its decision to approve or deny the request from the participant or designated representative as expeditiously as the
participant's condition requires, but no later than 72 hours after the date the interdisciplinary team receives the request for reassessment.
(iii) The interdisciplinary team may extend the 72-hour timeframe for notifying the participant or designated representative of its decision to approve or deny the request by no more than 5 additional days for either of the following reasons:
(A) The participant or designated representative requests the extension.
(B) The team documents its need for additional information and how the delay is in the interest of the participant.
(iv) The PACE organization must explain any denial of a request to the participant or the participant's designated representative orally and in writing. The PACE organization must provide the specific reasons for the denial in understandable language. The PACE
organization is responsible for the following:
(A) Informing the participant or designated representative of his or her right to appeal the decision as specified in Sec.460.122.
(B) Describing both the standard and expedited appeals processes, including the right to, and conditions for, obtaining expedited consideration of an appeal of a denial of services as specified in Sec.460.122.
(C) Describing the right to, and conditions for, continuation of appealed services through the period of an appeal as specified in Sec. 460.122(e).
(v) If the interdisciplinary team fails to provide the participant with timely notice of the resolution of the request or does not furnish the services required by the revised plan of care, this failure constitutes an adverse decision, and the participant's request must be
automatically processed by the PACE organization as an appeal in accordance with Sec.460.122.
(d) Changes to plan of care. Team members who conduct a reassessment must meet the following requirements:
(1) Reevaluate the participant's plan of care.
(2) Discuss any changes in the plan with the interdisciplinary team.
(3) Obtain approval of the revised plan from the interdisciplinary team and the participant (or
designated representative).
(4) Furnish any services included in the revised plan of care as a result of a reassessment to the participant as expeditiously as the participant's health condition requires.
(e) Documentation. Interdisciplinary team members must document all assessment and reassessment information in the participant's medical record.

(B) Describing both the standard and expedited appeals processes, including the right to, and conditions for, obtaining expedited consideration of an appeal of a denial of services as specified in Sec.460.122.
(C) Describing the right to, and conditions for, continuation of appealed services through the period of an appeal as specified in Sec. 460.122(e).
(v) If the interdisciplinary team fails to provide the participant with timely notice of the resolution of the request or does not furnish the services required by the revised plan of care, this failure constitutes an adverse decision, and the participant's request must be
automatically processed by the PACE organization as an appeal in accordance with Sec.460.122.
(d) Changes to plan of care. Team members who conduct a reassessment must meet the following requirements:
(1) Reevaluate the participant's plan of care.
(2) Discuss any changes in the plan with the interdisciplinary team.
(3) Obtain approval of the revised plan from the interdisciplinary team and the participant (or
designated representative).
(4) Furnish any services included in the revised plan of care as a result of a reassessment to the participant as expeditiously as the participant's health condition requires.
(e) Documentation. Interdisciplinary team members must document all assessment and reassessment information in the participant's medical record.

No
SDY 16 Do you have an audit system in place to ensure the prompt development of each participant’s comprehensive plan of care?
SDY 17 Do you ensure that members of the IDT complete a timely assessment?
Info Source Meeting minutes, Care Plans, Sign-in logs
Key Points Prompt and comprehensive assessments by each discipline represented on the IDT is paramount.
 Plan of Care (460.106) Owner / Self - Assessment
SDY 05 Lead Met / Not Met Met w/Note
Requirement (a) Basic requirement. The interdisciplinary team must promptly develop a comprehensive plan of care for each participant.
(b)Content of plan of care. The plan of care must meet the following requirements:
(1) Specify the care needed to meet the participant’s medical, physical, emotional, and social needs, as identified in the initial comprehensive assessment.
(2)Identifiy measurable outcomes to be achieved.
(c) Implementation of the plan of care.
(1) The team must implement, coordinate, and monitor the plan of care whether the services are furnished by PACE employees or contractors.
(2) The team must continuously monitor the participant’s health and psychosocial status, as well as the effectiveness of the plan of care, through the provision of services, informal observation, input from participants or caregivers, and communications among
members of the interdisciplinary team and other providers.
(d)Evaluation of plan of care. On at least a semi-annual basis, the inter-disciplinary team must revaluate the plan of care, including defined out-comes, and make changes as necessary. Add Note
(e)Participant and caregiver involvement in plan of care. The team must develop, review, and reevaluate the plan of care in collaboration with the participant or caregiver, or both, to ensure that there is agreement with the
plan of care and that the participant’s concerns are addressed.
(f) Documentation.The team must document the plan of care, and any changes made to it, in the participant’s medical record.

Yes / No
SDY 18 Is each POC is evaluated at least every six (6) months by the IDT?
SDY 19 Do you ensure participant and/or caregiver involvement in the POC?
SDY 20 Is each plan must be documented in MR?
SDY 21 Do you have a clear process for ensuring that IDT continually monitor the Plan of Care and ensure its effectiveness?
What is your process?
SDY 22 Do you have a clear process for ensuring that IDT involve participant and/or caregivers in the care planning process?
What is your process?
Info Source
Key Points
Internal Quality Assessment and Performance Improvement Activities (460.136) Owner / Self - Assessment
QAP 04 Lead Met / Not Met Met w/Note
Requirement a) Quality assessment and performance improvement requirements. A PACE organization must do the following:
(1) Use a set of outcome measures to identify areas of good or problematic performance.
(2) Take actions targeted at maintaining or improving care based on outcome measures.
(3) Incorporate actions resulting in performance improvement into standards of practice for the delivery of care and periodically track performance to ensure that any performance improvements are sustained over time.
(4) Set priorities for performance improvement, considering prevalence and severity of identified problems, and give priority to improvement activities that affect clinical outcomes.
(5) Immediately correct any identified problem that directly or potentially threatens the health and safety of a PACE participant.
(b) Quality assessment and performance improvement coordinator. A PACE organization must designate an individual to coordinate and oversee implementation of quality assessment and performance improvement activities.
(c) Involvement in quality assessment and performance improvement activities.
(1) A PACE organization must ensure that all interdisciplinary team members, PACE staff, and contract providers are involved in the development and implementation of quality assessment and performance improvement activities and are aware of the results of
Add Note
these activities.
(2) The quality improvement coordinator must encourage a PACE participant and his or her caregivers to be involved in quality assessment and performance improvement activities, including providing information about their satisfaction with services.

Yes / No
QAP 1 In the past year, have you measured improvements that have been successful?
Provide examples.
QAP 2 Do you have indicators or improvements that have not met your goals for them?
Provide plan to improve.
QAP 3 Do you share QAPI results with staff?
How do you share QAPI results with staff?
QAP 4 Does your written QAPI Plan identify outcome indicators that are being measured in your effort to improve for the current year?
List outcome indicators that are being measured.
QAP 5 Do you conduct participant satisfaction surveys?
Describe how you incorporate results into QAPI Plan.
QAP 6 Do you conduct caregiver satisfaction surveys?
Describe how you incorporate results into QAPI Plan.
QAP 7 Do you reach or exceed 80% compliance on Pneumovax Immunization?
What was your average score for the past year?
QAP 8 Do you reach or exceed 80% compliance on Influenza Immunization?
What was your average score for the past year?
QAP 9 Do you have a system to ensure data accuracy?
Describe the system.
QAP 10 In the past year, have there been any incidents of a safety problem, level 2 events or negative outcome related to a participant?
If so, what occurred and what actions were taken?
QAP 11 Do you monitor effectiveness of interventions and that changes are sustained over time?
QAP 12 Do you have a risk management program?
Describe proactive risk reductions that have been done
 QAP 13 Do you use a Root Cause Analysis tool to review level 2 reportable events?
QAP 14 Do you have a system to track and trend all incidents?
QAP 15 Do you have a process in place to identify quality of care issues?
Describe the process and one example of how quality of care issues have been addressed over the past year?
QAP 16 Do you have ongoing screening activities or critical indicators are routinely used to monitor care?
QAP 17 Do you involve staff in the quality improvement process?
Describe how this is done.
QAP 18 Do you involve contractors in the quality improvement process?
Describe how this is done.
QAP 19 Do you have a committee with community input that provides feedback related to ethical decision making?
QAP 20 Do you meet external quality assessment and reporting requirements, as specified by CMS or the State Administering Agency, in accordance with 460.202?
QAP 21 Do you ensure the industry standard codes are utilized – CPT, DRG, ICD-9 and non-standard coding are fully documented, approved and utilized consistently throughout the organization?
QAP 22 Do you have a plan for privacy and transmission and code sets?
QAP 23 Do you ensure that data elements are reported uniformly by all providers, and that reports from multiple sources are comparable and can be reliably merged into more comprehensive reports?
QAP 24 Do you ensure the validity of data from any manual system?
Source
Key Points
PACE Program Self-Assessment Tool
ADMINISTRATIVE ELEMENTS
Contracted Services (460.70) Clarifi- Owner / Self-Assessment
CTS 01 cation Lead Met / Not Met Met w/Note
Requirement (a)General rule. The PACE organization must have a written contract with each outside organization, agency, or individual that furnishes administrative or care-related services not furnished directly by the PACE organization except for emergency services as describe in §460.100.
(b) Contract requirements. A contract between a PACE organization and a contractor must meet the following requirements
(1)Contract only with an entity that meets all applicable Federal and State requirements… including Medicare and Medicaid requirements…
(2) A contractor must be accessible to participants, located either within or near the PACE organization’s service area.
(3) A PACE organization must designate an official liaison to coordinate activities between contractors and the organization
(d)Content of contract. Each contract must be in writing and include the following information:
(1) Name of contractor
(2) Services furnished (including work schedule if appropriate).
(3)Payment rate and method.
(4) Terms of the contract, including beginning and ending dates, methods of extension, renegotiation, and termination.
(5)Contractor agreement to do the following:
(i)Furnish only those services authorized by the PACE interdisciplinary team
(ii) Accept payment from the PACE organization as payment in full, and not bill participants, CMS the State administering agency, or private insurers.
(iii) Hold harmless CMS, the State, and PACE participants if the PACE organization does not pay for services performed by the contractor in accordance with the contract.
(iv)Not assign the contract or delegate duties under the contract unless it obtains prior written approval from the PACE organization.
(v) Submit reports required by the PACE organization.
(vi) Agree to perform all the duties related to its position as specified in this part. Add Note
(vii) Participate in interdisciplinary team meeting as required.
(viii) Agree to be accountable to the PACE organization.
(ix) Cooperate with the competency evaluation program and direct participant care requirements specified in §460.71.
(e) Contracting with another entity to furnish PACE Center services.
(1) A PACE organization may only contract for PACE Center services if it is fiscally sound as defined in §460.80(a) of this part and has demonstrated competence with the PACE model as evidenced by successful monitoring by CMS and the State administering agency.
(2) The PACE organization retains responsibility for all participants and may only contract for the PACE Center services identified in §460.98(d).

Yes / No
CTS 1 Do you maintain a written contract with each outside organization, agency and individuals providing administrative or care related services to participants (except emergency services)?
CTS 2 Do your contractors meet all State and Federal requirements?
CTS 3 Do your contractors designate someone to coordinate services between the contractor and the organization?
CTS 4 Is your current list of contractors on file and available upon request?
CTS 5 Do your contracts include contractor name, services provided, rate, and terms?
CTS 6 Does the contractor agree to furnish only those services authorized by the PACE interdisciplinary team?
CTS 7 Does the contractor agree to accept payment from the PACE organization as payment in full, and not bill participants, CMS, the State administering agency, or private insurers?
CTS 8 Does the contractor agree to hold harmless CMS, the State, and PACE participants if the PACE Organization does not pay for services performed by the contractor in accordance with the contract?
CTS 9 Does the contractor agree to not assign the contract or delegate duties under the contract unless it obtains prior written approval from the PACE Organization?
CTS 10 Does the contractor agree to submit reports required by the PACE organization?
CTS 11 Does the contractor agree to agree to perform all the duties related to its position as specified in this part?
CTS 12 Does the contractor agree to participate in interdisciplinary team meeting as required?
CTS 13 Does the contractor agree to cooperate with the competency evaluation program and direct participant care requirements specified in §460.71?
CTS 14 Does the contractor agree to scope of services outlined in the contract is accurate and clear?
CTS 15 Does the contractor agree to cross reference the services delivery table to make certain all of the services that your PACE program states are contracted and are represented by a template or executed contract?
CTS 16 Is there a process in place to maintain a current list of providers?
CTS 17 Is this information given to new enrollees?
CTS 18 Is this information sent to all enrollees annually?
CTS 19 Do all institutional contractors, such as a hospital or skilled nursing facility, meet Medicare or Medicaid participation requirements?
CTS 20 Do practitioners or suppliers meet Medicare or Medicaid requirements applicable to the services it furnishes?
CTS 21 For administrative contracts such as records maintenance and storage, is there a Business Associate agreement in place?
CTS 22 Is Information provided to contractors related to your QAPI?
CTS 23 Is Information provided to contractors related to the grievance and appeals process?
CTS 24 Is Information provided to contractors related to an orientation and understanding of PACE, Philosophy of care, IDT process?
CTS 25 A process in place to verify the competency of the contracted provider?
CTS 26 Do contract providers have in place processes to determine and assure compliance with the requirements of §460.68(a) regarding persons with criminal convictions?
CTS 27 Do contract providers have in place processes to determine and assure compliance with current certifications or licenses for their respective positions?
CTS 28 Do contract providers have in place processes to determine and assure compliance with and are free of communicable diseases?
CTS 29 Do contract providers have in place processes to determine and assure their employees have been oriented to the PACE program?
CTS 30 Do contract providers have in place processes to determine and assure that employees abide by the philosophy, practices, and protocols of the PACE organization?
CTS 31 Is there a process in place to track compliance with all contract oversight and verification requirements?
CTS 32 Does this individual make site visits to providers such as personal care aide providers to verify compliance with contract and regulatory requirements?
CTS 33 Is there evidence in the contract records that verifies areas such as licensure, OIG checks, etc?
Info Source Contractor agreements, training materials, contract monitoring/oversight logs and documentation
Key Points The PACE organization remains accountable for and maintains authority over the contractor and the services provided by the contractor.
 Fiscal Soundness (460.80) Owner / Self-Assessment
FIN 01 Lead Met / Not Met Met w/Note
Requirement (a) Fiscally Sound operation. A PACE organization must have a fiscally sound operation, as demonstrated by the following:
(1) Total assets greater than total liabilities
(2) Sufficient cash flow and adequate liquidity to meet obligations as they become due.
(3) A net operating surplus or a financial plan for maintaining solvency that is satisfactory to CMS and the State administering agency.
(b) Insolvency plan. The organization must have a documented plan in the event of insolvency, approved by CMS and the State administering agency, which provides for the following:
(1) Continuation of benefits for the duration of the period for which capitation payment has been made.
(2) Continuation of benefits to participants who are confined in a hospital on the date of insolvency until their discharge.
(3) Protection of participants from liability for payment of fees that are the legal obligation of the PACE organization.
(c) Arrangements to cover expenses. (1) A PACE organization must demonstrate that it has arrangements to cover expenses in the amount of
at least the sum of the following in the event it becomes insolvent:
(i) One month's total capitation revenue to cover expenses the month before insolvency. Add Note
(ii) One month's average payment to all contractors, based on the prior quarter's average payment, to cover expenses the month after the date it declares insolvency or ceases operations.
(2) Arrangements to cover expenses may include, but are not limited to, the following:
(i) Insolvency insurance or reinsurance.
(ii) Hold harmless arrangement.
(iii) Letters of credit, guarantees, net worth, restricted State reserves, or State law provisions.

Yes / No
FIN 1 Is your organization's financial sponsor in good standing with Medicaid or Medicare?
FIN 2 Can you provide projections through break even and one year beyond?
FIN 3 Can you provide quarterly balance sheets?
FIN 4 Can you provide quarterly statements of revenues and expenses?
FIN 5 Do you have sufficient cash flow reserves?
Info Source Cast Flow Analysis Documents, Balance Sheets, Financial Reports
Key Points
Explanation of Rights (460.116) Owner / Self-Assessment
PRT 04 Lead Met / Not Met Met w/Note
Requirement (a) A PACE organization must have written policies and implement procedures to ensure that the particpant, his or her representative, if any, and staff understand these rights.
(b) The PACE organization must fully explain the rights to the participant and his or her representative, if any, at the time of enrollment in a manner understood by the participant.
(c) The PACE organization must meet the following requirements;
(1) Write the participant rights in English adn in any other principal languages of the community. Add Note
(2) Display the participant rights in a prominant place in the PACE center.

Yes / No
PRT 1 Do you have a clear, accurate, and written Bill of Rights that includes at a minimum all rights in 460.112?
PRT 2 Does it and inform the participant of his/her rights, responsibilities, rules and regulations?
PRT 3 Do you ensure the Bill of Rights are provided in a timely manner and assure participant’s understanding?
PRT 4 Do you ensure participants privacy and confidentiality in all settings?
PRT 5 Do you ensure participants reasonable access to a telephone?
PRT 6 Do you ensure that participants are encouraged and assisted to exercise rights as a participant in appeals process, civil rights and legal rights?
PRT 7 Do you ensure that participants are encouraged and assisted to recommend changes to services and policies?
PRT 8 Do you ensure participants receive accurate, easily understood information necessary in making an informed decision and assist when needed?
PRT 9 Do you ensure participants are informed in writing of available services (both directly and through contractors) before AND at the time of enrollment?
PRT 10 Do you ensure participants are informed in writing of available services (both directly and through contractors) when there is a change in services?
PRT 11 Do you allow participants to examine or upon reasonable request, assist with the examination of the most recent results of the organization’s CMS or SAA audit?
PRT 12 Do you ensure each participant has the right to choose an in-network provider that’s capable of providing sufficient care?
PRT 13 Do you ensure that each participant has the right to access emergency services?
PRT 14 Do you ensure that each participant has the right to have advance directives explained?
PRT 15 Do you ensure that each participant has the right to informed of health and functional status?
PRT 16 Do you ensure that each participant has the right to participate in development and implementation of POC?
PRT 17 Do you ensure that each participant has the right to request reassessment by IDT?
PRT 18 Do you ensure that each participant has the right to given reasonable advance notice in writing of any transfer and the justification?
PRT 19 Do you ensure that each participant has the right to communicate with provider knowing his/her PHI will remain confidential?
PRT 20 Do you ensure that each participant has the right to review and copy his/her medical record and request amendments to those records?
PRT 21 Do you ensure that each participant has the right to levy a complaint or appeal any treatment decision?
PRT 22 Have you developed and implemented a policy that defines whether and how restraints will be used as a treatment option and examples of allowable restraints?
PRT 23 Do you ensure limited use of restraints (both physical and chemical) to the lease restrictive and most effective methods available?
PRT 24 When using restraints do you ensure they are imposed for a defined, limited period of time, based upon the assessed need?
PRT 25 When using restraints do you ensure they are imposed in accordance with safe and appropriate restraining techniques?
PRT 26 When using restraints do you ensure they are used only when other less restrictive methods have been found to be ineffective?
PRT 27 When using restraints do you ensure they are removed or ended at the earliest possible time?
PRT 28 Do appropriate staff continually assess, monitor and reevaluate the condition of the restrained participant?
PRT 29 Have you established a documented process for responding to and rectifying any violation of a participant’s rights?
Info Source Copy of Bill of Rights, Policy and Procedures
Key Points
 Greivance Process (460.120) Owner / Self-Assessment
PRT 06 Lead Met / Not Met Met w/Note
Requirement For purposes of this part, a grievance is a complaint, either written or oral, expressing dissatisfaction with services delivery or the quality of care furnished.
(a) Process to resolve grievances. A PACE organization must have formal written process to evaluate and resolve medical and non-medical grievances by participants, their family members, or representatives.
(b)Notification to participants. Upon enrollment, and at least annually thereafter, the PACE organization must give a participant written information on the grievance process.
(c) Minimum requirements. At a minimum, the PACE organization’s grievance process must include written procedures for the following:
(1) How a participant files a grievance.
(2)Documentation of a participant’s grievance.
(3) Response to, and resolution of, grievances in a timely manner.
(4) Maintenance of confidentiality of a participant’s grievance.
Add Note
(d) Continuing care during grievance process. The PACE organization must continue to furnish all required services to the participant during the grievance process.
(e) Explaining the grievance process. The PACE organization must discuss with and provide to the participant in writing the specific steps, including timeframes for response, that will be taken to resolve the participant’s grievance.
(f) Analyzing grievance information. The PACE organization must maintain, aggregate, and analyze information on grievance proceedings. This information must be used in the PACE organization’s internal quality assessment and performance improvement program

Yes / No
PRT 30 Do you have a policy in place covering how a participant files a grievance?
PRT 31 Do you have a policy in place that contains documentation of a participant’s grievance?
PRT 32 Do you have a policy in place on how to respond to and resolve grievances in a timely manner.
PRT 33 Do you have a policy in place covering maintenance of confidentiality of a participant’s grievance?
PRT 34 Do you have a policy in place that requires PO to continue to furnish all required services to the participant during the grievance process.
PRT 35 Do you have a policy in place requiring that the PACE PO discuss with and provide to the participant in writing the specific steps, including timeframes for response that will be taken to resolve the participant’s grievance?
PRT 36 Do you have a policy in place to discuss grievance policy at enrollment?
PRT 37 Do you have a process in place to annually notify participants of the grievance process?
PRT 38 Do you maintain a log of all grievances?
PRT 39 Is your grievance information is tracked and trended as part of QAPI?
PRT 40 Are Staff trained at employment and annually thereafter in the grievance policy?
PRT 41 Are contract providers made aware of the grievance policy?
PRT 42 Are grievances tracked and trended as part of your QAPI?
PRT 43 Is grievance information kept in a secure location in compliance with HIPAA?
Info Source Enrollment procedures, Enrollment Forms
Key Points
PACE Organization's Appeals Process (460.122) Owner / Self-Assessment
PRT 07 Lead Met / Not Met Met w/Note
Requirement For purposes of this section, an appeal is a participant’s action taken with respect to the PACE organization’s noncoverage of, or nonpayment for, a service including denials, reductions, or termination of services.
(a)PACE organization’s written appeals process. The PACE organization must have a formal written appeals process, with specified timeframes for response, to address noncoverage or nonpayment of a service.
(b) Notification of participants. Upon enrollment, at least annually thereafter, and whenever the interdisciplinary team denies a request for services or payment, the PACE organization must give a participant written information on the appeals process.
(c) Minimum requirements. At a minimum, the PACE organization’s appeals process must include
written procedures for the following:
(1) Timely preparation and processing of a written denial of coverage or payment as provided in §460.104(c)(3).
(2) How a participant files an appeal.
(3) Documentation of a participant’s appeal.
(4) Appointment of an appropriately credentialed and impartial third party who was not involved in the original action and who does not have a stake in the outcome of the appeal to review the participant’s appeal.
(5) Responses to, and resolution of, appeals as expeditiously as the participant’s health condition requires, but no later than 30 calendar days after the organization received an appeal.
(6) Maintenance of confidentiality of appeals.
(d) Notification. A PACE organization must give all parties involved in the appeal the following:
(1) Appropriate written notification.
(2) A reasonable opportunity to present evidence related to the dispute, in person, as well as in writing.
(e) Services furnished during appeals process. During the appeals process, the PACE organization must meet the following requirements:
(f) Expedited appeals process
(1) A PACE organization must have an expedited appeals process for situations in which the participant believes that his or her life, health, or ability to regain or maintain maximum function could be seriously jeopardized, absent provision of the service in dispute.
(2) Except as provided in paragraph (f)(3) of this section, the PACE organization must respond to the appeal as expeditiously as the participant’s health condition requires, but no later than 72 hours after it receives the appeal.
(3) The PACE organization may extend the 72-hour timeframe by up to 14 calendar days for either of the following reasons: Add Note
(i) The participant requests the extension.
(ii) The organization justifies to the State administering agency the need for additional information and how the delay is in the interest of the participant.
(g) Determination in favor of participant. A PACE organization must furnish the disputed service as expeditiously as the participant’s health condition requires if a determination is made in favor of the participant on appeal.
(h) Determination adverse to participant. For a determination that is wholly or partially adverse to a participant, at the same time the decision is made, the PACE organization must notify the following:
(1) CMS.
(2) The State administering agency.
(3) The participant.
(i) Analyzing appeals information. A PACE organization must maintain, aggregate, and analyze information on appeal proceedings and use this information in the organization’s internal quality

Yes / No
PRT 44 Is there a policy in place that addresses how a participant files an appeal?
PRT 45 Is there a policy in place regarding documentation of a participant’s appeal?
PRT 46 Is there a policy in place that provides for the appointment of an appropriately credentialed and impartial third party who was not involved in the original action and who does not have a stake in the outcome of the appeal to review the participant’s appe
PRT 47 Is there a policy in place on how to respond to and resolve appeals as expeditiously as the participant’s health condition requires, but no later than 30 calendar days after the organization receives an appeal?
 PRT 48 Is there a policy in place that maintains confidentiality of appeals?
PRT 49 Is there a policy in place that addresses expedited appeals as may be necessary?
PRT 50 Is there a policy in place on notification process?
PRT 51 Is there a policy in place that describes the process by which services continue during the appeal process as required under Medicaid?
PRT 52 Is there a policy in place that describes the process to notify CMS, the State and the participant of an adverse determination?
PRT 53 Is there a policy in place that describes a process to notify the participant of their external appeal rights under Medicare and/or Medicaid?
PRT 54 Do you track and trend appeals in the QAPI?
PRT 55 Is there a process in place to assure that all staff are trained at employment and annually thereafter on the appeals policy and procedure?
PRT 56 Have all letters disseminated to participants been pre-approved by the SAA and CMS?
Info Source Enrollment procedures, Enrollment Forms
Key Points
Additional Appeal Rights Under Medicare or Medicaid (460.124) Owner /
PRT 08 Lead Met / Not Met Met w/Note
Requirement A PACE organization must inform a participant in writing of his or her appeal rights under Medicare or Medicaid managed care, or both, assist the participant in choosing which to pursue if both are applicable, and forward the appeal to the appropriate external entity.
Add Note

Yes / No
PRT 57 Do you have a clearly written policy that documents the enrollment process?
PRT 58 Does your policy make clear that participants must be 55 or older?
PRT 59 Does your policy make clear that participants must be determined by SAA to meet level of care requirement?
PRT 60 Does your policy make clear that participants must reside in the service area?
PRT 61 Does your policy meet other program specific eligibility requirements imposed under the program agreement?
Info Source Enrollment procedures, Enrollment Forms
Key Points
Enrollment Process (460.162) Owner / Self-Assessment
MKT 03 Lead Met / Not Met Met w/Note
Requirement (a) Intake process. Intake is an intensive process during which PACE staff members make one or more visits to a potential participant's place of residence and the potential participant makes one or more visits to the PACE center. At a minimum, the intake process must include the
following activities:
(1) The PACE staff must explain to the potential participant and his or her representative or caregiver the following information:
(i) The PACE program, using a copy of the enrollment agreement described in Sec.460.154, specifically references the elements of the agreement including but not limited to Sec.460.154(e), (i) through (m), and (r).
(ii) The requirement that the PACE organization would be the participant's sole service provider and clarification that the PACE organization guarantees access to services, but not to a specific provider.
(iii) A list of the employees of the PACE organization who furnish care and the most current list of contracted health care providers under Sec. 460.70(c).
(iv) Monthly premiums, if any.
(v) Any Medicaid spenddown obligations.
(vi) Post-eligibility treatment of income.
(2) The potential participant must sign a release to allow the PACE organization to obtain his or her medical and financial information and eligibility status for Medicare and Medicaid.
(3) The State administering agency must assess the potential participant, including any individual who is not eligible for Medicaid, to ensure that he or she needs the level of care required under the State Medicaid plan for coverage of nursing facility services, which indicates that the
individual's health status is comparable to the health status of individuals who have participated in the PACE demonstration waiver programs.
(4) PACE staff must assess the potential participant to ensure that he or she can be cared for appropriately in a community setting and that he or she meets all requirements for PACE eligibility specified in this part. Add Note
(b) Denial of Enrollment. If a prospective participant is denied enrollment because his or her health or safety would be jeopardized by living in a community setting, the PACE organization must meet the following requirements:
(1) Notify the individual in writing of the reason for the denial.
(2) Refer the individual to alternative services, as appropriate.
(3) Maintain supporting documentation of the reason for the denial.
(4) Notify CMS and the State administering agency and make the documentation available for review.

Yes / No
MKT 1 In your enrollment process do you clearly explain monthly premiums, if any?
MKT 2 In your enrollment process do you clearly explain Medicaid spend down obligations?
MKT 3 In your enrollment process do you clearly explain that SAA will review potential participants for eligibility?
MKT 4 In your enrollment process do you clearly explain that the organization must assess the participant to ensure that he/she can be cared for appropriately and meets all eligibility requirements?
MKT 5 When denying enrollment do you notify the individual in writing of the reason?
MKT 6 When denying enrollment do you refer to alternate services as appropriate?
MKT 7 When denying enrollment do you maintain supporting documentation of the reason for the denial?
MKT 8 When denying enrollment do you notify CMS and SAA and make documentation available for review?
MKT 9 Does your enrollment agreement contain name, sex, and DOB?
MKT 10 Does your enrollment agreement contain Medicare beneficiary status and number, if applicable?
MKT 11 Does your enrollment agreement contain Medicaid recipient status and number, if applicable?
MKT 12 Does your enrollment agreement contain other health insurance information, if applicable?
MKT 13 Does your enrollment agreement stipulate conditions for enrollment and disenrollment in PACE?
MKT 14 Does your enrollment agreement contain description of premiums and procedures for payment of premiums?
MKT 15 Does your enrollment agreement contain notification that Medicaid or dually eligible participants are not liable for any premiums?
MKT 16 Does your enrollment agreement contain notification that Medicaid or dually eligible participants may be liable for any applicable spend down liability under 435.121 and 435.831?
MKT 17 Does your enrollment agreement contain notification that Medicaid or dually eligible participants may be liable for any amounts under the post-eligibility treatment of income process under 460.184?
MKT 18 Does your enrollment agreement inform participant that he or she may not disenroll from PACE at a SSA office?
MKT 19 Does your enrollment agreement inform participant that enrollment in PACE results in disenrollment from any other Medicare or Medicaid prepayment plan or optional benefit?
MKT 20 Does your enrollment agreement inform participant of consequences of subsequent enrollment in other optional Medicare and Medicaid covered services, and how services are obtained from organization?
MKT 21 Does your enrollment agreement provide a description of procedures for obtaining emergency and urgently needed out-of-network services?
MKT 22 Does your enrollment agreement provide a participant bill of rights?
MKT 23 Does your enrollment agreement describe the grievances and appeals process, including numbers for use in appeals?
MKT 24 Does your enrollment agreement make clear that participant has obligation to inform organization of a move or lengthy absence from the service area?
 MKT 25 Does your enrollment agreement require acknowledgement that participant understands the requirement that the organization must be the applicant’s sole service provider?
MKT 26 Does your enrollment agreement provide a statement that organization has an agreement with CMS and SAA that is subject to renewal on a periodic basis and, if the agreement is not renewed, the program will be terminated?
MKT 27 Does your agreement require authorization from application to disclose and exchange information with CMS, its agents, SAA and organization?
MKT 28 Does your enrollment agreement include applicant’s signature and the date?
MKT 29 Upon enrollment do you provide participant a copy of enrollment agreement?
MKT 30 Upon enrollment do you provide participant a membership card?
MKT 31 Upon enrollment do you provide participant Emergency information to post in his/her home?
MKT 32 Upon enrollment do you submit participant information to CMS and SAA?
MKT 33 At any time during enrollment if any changes to the agreement are made do you give an updated copy of information to the participant?
MKT 34 At any time during enrollment if any changes to the agreement are made do you explain the changes to the participant, representative or caregiver in a manner they understand?
MKT 35 Do you ensure that enrollment is effective on the first day of the calendar month following the date the organization receives the signed agreement?
MKT 36 Do you ensure that enrollment continues until participant’s death?
MKT 37 Do you ensure that enrollment continues until participant voluntarily disenrolls?
MKT 38 Do you ensure that enrollment continues until participant is involuntarily disenrolled as described in 460.164?
MKT 39 Do you ensure that at least annually, SAA reevaluates participant’s level of care required under the State Medicaid plan for coverage of nursing facility services?
MKT 40 Do you retain MR, documentation for the reason for waiving the annual recertification requirement?
Info Source
Key Points
Voluntary Disenrollment (460.162) Owner /
MKT 08 Lead Met / Not Met Met w/Note
Requirement A PACE participant may voluntarily disenroll from the program without cause at any time. Add Note
Yes / No
MKT 41 Does your voluntary disenrollment policy state that participant may disenroll without cause at any time?
MKT 42 Do you ensure that your voluntary disenrollment process is not burdensome and occurs in a timely manner?
Info Source
Key Points
Involuntary Disenrollment (460.164) Owner /
MKT 09 Lead Met / Not Met Met w/Note
Requirement (a) Reasons for involuntary disenrollment. A participant may be involuntarily disenrolled for any of the following reasons:
(1) The participant fails to pay, or to make satisfactory arrangements to pay, any premium due the PACE organization after a 30-day grace period.
(2) The participant engages in disruptive or threatening behavior, as described in paragraph (b) of this section.
(3) The participant moves out of the PACE program services area or is out of the service area for more than 30 consecutive days, unless the PACE organization agrees to a longer absence due to extenuating circumstances.
(4) The participant is determined to no longer meet the State Medicaid nursing facility level of care requirements and is not deemed eligible.
(5) The PACE program agreement with CMS and the State administering agency is not renewed or is terminated.
(6) The PACE organization is unable to offer health care services due to the loss of State licenses or contracts with outside providers.
(b) Disruptive or threatening behavior. For purposes of this section, a participant who engages in disruptive or threatening behavior refers to a participant who exhibits either of the following:
(1) A participant whose behavior jeopardizes his or her health or safety, or the safety of others; or
(2) A participant with decision-making capacity who consistently refuses to comply with his or her individual plan of care or the terms of the PACE enrollment agreement.
(c) Documentation of disruptive or threatening behavior. If a PACE organization proposes to disenroll a participant who is disruptive or threatening, the organization must document the following information in the participant's medical record:
(1) The reasons for proposing to disenroll the participant.
(2) All efforts to remedy the situation.
(d) Noncompliant behavior. Add Note
(1) A PACE organization may not disenroll a PACE participant on the grounds that the participant has engaged in noncompliant behavior if the behavior is related to a mental or physical condition of theparticipant, unless the participant's behavior jeopardizes his or her health or safety,
or the safety of others.
(2) For purposes of this section, noncompliant behavior includes repeated noncompliance with medical advice and repeated failure to keep
appointments.
(e) State administering agency review and final determination. Before an involuntary disenrollment is effective, the State administering agency must review it and determine in a timely manner that the PACE organization has adequately documented acceptable grounds for
disenrollment.

Yes / No
MKT 43 Does your policies clearly state that involuntary disenrollment occurs when a participant fails to pay after 30-day grace period?
MKT 44 Does your policies clearly state that involuntary disenrollment occurs when participant engages in disruptive or threatening behavior as described in paragraph (b) of the regulations?
MKT 45 Does your policies clearly state that involuntary disenrollment occurs when participant moves out of the service area or out of service area for more than 30 days? (unless the organization agrees to a longer absence)
MKT 46 Does your policies clearly state that involuntary disenrollment occurs when participants no longer meet State Medicaid nursing facility level of care requirements and is not deemed eligible?
MKT 47 Does your policies clearly state that involuntary disenrollment occurs when the agreement between organization and CMS and SAA is not renewed?
MKT 48 Does your policies clearly state that involuntary disenrollment occurs when the organization is unable to offer health care services due to loss of State licenses or contracts with outside providers?
MKT 49 When disenrolling a participant do you use the most expedient process allowed under Medicare and Medicaid procedures, as set forth in the PACE program agreement?
MKT 50 When disenrolling a participant do you coordinate the disenrollment date between Medicare and Medicaid?
MKT 51 When disenrolling a participant do you give reasonable advance notice to the participant?
MKT 52 Do you clarify to enrollees/participants that when disenrolling a participant, he or she must continue to use services and remain liable for any premiums?
MKT 53 Do you continue to provide all services when disenrolling a participant?
MKT 54 Do you allow participants to be reinstated in the program?
MKT 55 Do you clarify to enrollees/participants that if the reason for disenrollment is failure to pay the premium and the participant pays the premium before the effective date of disenrollment, he/she is reinstated in the program with a break in coverage?
MKT 56 Do you ensure a policy and procedure is in place to document the reason for all voluntary and involuntary disenrollment?
MKT 57 Do you make documentation available for review by CMS and SAA?
MKT 58 Do you use the information on voluntary disenrollment in the organization’s QAPI program?
Info Source
Key Points
PACE Program Self-Assessment Tool
AD HOC ELEMENTS
Record Maintenance and Reporting Personnel Training Clarifi- Owner / Self-Assessment
cation Lead Met / Not Met Met w/Note

Add Note
Yes / No
RM 1 Do you have a formal written process for performing criminal background checks for employees and contractors furnishing direct participant care?
RM 2 Do you screen each employee and contractor to verify that they have not been excluded from Medicare and Medicaid programs?
RM 3 Do you have a formal written Conflict of Interest policy?
RM 4 Does your program have written policies and procedures for ensuring that all employees and contracted staff providing care directly to participants demonstrate the skills necessary for performance of the position?
RM 5 Do your contractor agreements contain language describing your policies and procedures to assure compliance?
RM 6 Does your program have a systematic orientation for new employees and contracted staff that covers your organization’s mission, philosophy?
RM 7 Does your program have a systematic orientation for new employees and contracted staff that covers policies on participant rights?
RM 8 Does your program have a systematic orientation for new employees and contracted staff that covers policies on your emergency plan?
RM 9 Does your program have a systematic orientation for new employees and contracted staff that covers policies on ethics?
RM 10 Does your program have a systematic orientation for new employees and contracted staff that covers policies on covered services?
RM 11 Does your program have a systematic orientation for new employees and contracted staff that covers policies related to roles and responsibilities for the specific position?
RM 12 Does your program have a process in place for ensuring that existing staff attend an updated orientation on a periodic basis?
RM 13 Does your program have a process to evaluate competencies and document (skills, knowledge and abilities specific to the position) that must be demonstrated by direct participant care contractors before caring for participants? (this item for employed sta
RM 14 Does your program have process by which qualified professionals reevaluate competencies of contracted direct care staff on an annual basis?
RM 15 Do you have a designated staff member who oversees orientation, competency assessment and training for employees and works closely with the contract liaison to ensure compliance by contracted staff?
RM 16 Is there a process in place to collect data, maintain records and submit reports as required by CMS and the State Administering Agency?
Who has access to data and records?
RM 17 Does the process include participant health outcomes data, financial books, medical records, personnel records, or employee health records?
RM 18 Is there a policy on safeguarding all data?
RM 19 Are medical records retained for 10 years post discharge or death? C
RM 20 If yes, does the policy contain a check-out system so that the location of any medical record is known at any time?
RM 21 If yes, does the policy contain circumstances in which an original record may leave the PACE center?
RM 22 If yes, does the policy contain procedures for securing/safeguarding records after hours?
RM 23 If yes, does the policy contain procedures to protect records from damage such as fire and flood?
If an electronic health record system is being used, how is information backed up and where is the server?
RM 24 Does the policy contain procedures for transmitting medical record information via fax?
RM 25 Does the policy contain plans for training and education of staff at orientation and on an ongoing basis related to protecting the confidentiality of PHI?
RM 26 Is there a process to ensure records are complete, accurate and up to date (i.e., filing of participant information)?
RM 27 Are there established timeframes to complete medical documentation in the participant record?
RM 28 Are steps taken to improve staff performance related to the above.? (i.e., are routine audits of the medical record done to assure accuracy, completeness, logic and consistency?)
RM 29 Are procedures in place to address when a participant or caregiver requests to review and copy his or her own medical record or to amend those records?
RM 30 Are there policies and procedures in place to demonstrate that they have instituted a minimum necessary disclosure of PHI?
RM 31 Does the policy contain uses and disclosure procedures including exceptions?
RM 32 Are staff oriented and trained annually on PHI and if so, how often?
RM 33 Is there a process in place to “de-identify” PHI?
RM 34 Is there a policy in place that requires the program not to use either a participant’s SS# or their HIC# as a medical record number?
RM 35 Is there a process in place to collect data, maintain records and submit reports as required by CMS and the State Administering Agency?
Who has access to data and records?
RM 36 Does the process include participant health outcomes data?
RM 37 Does the process include financial books and records?
RM 38 Does the process include medical records?
RM 39 Does the process include personnel records?
RM 40 Does the process include employee health records?
RM 41 Is there a policy on safeguarding all data?
RM 42 Are medical records retained for 10 years post discharge or death? (note: Medicare Part D requires records to be retained for 10 years, since Medicare part D information is contained in the participant’s medical record a retention period of 10 years is required)
RM 43 If yes, does the policy contain a check-out system so that the location of any medical record is known at any time?
RM 44 If yes, does the policy contain circumstances in which an original record may leave the PACE center?
RM 45 If yes, does the policy contain procedures for securing/safeguarding records after hours?
RM 46 If yes, does the policy contain procedures to protect records from damage such as fire and flood?
If an electronic health record system is being used, how is information backed up and where is the server?
RM 47 Does the policy contain procedures for transmitting medical record information via fax?
RM 48 Does the policy contain plans for training and education of staff at orientation and on an ongoing basis related to protecting the confidentiality of PHI?
RM 49 Is there a process to ensure records are complete, accurate and up to date (i.e., filing of participant information)?
RM 50 Are there established timeframes to complete medical documentation in the participant record?
RM 51 Are steps taken to improve staff performance related to the above.? (i.e., are routine audits of the medical record done to assure accuracy, completeness, logic and consistency?)
RM 52 Are procedures in place to address when a participant or caregiver requests to review and copy his or her own medical record or to amend those records?
RM 53 Are there policies and procedures in place to demonstrate that they have instituted a minimum necessary disclosure of PHI?
RM 54 Does the policy contain uses and disclosure procedures including exceptions?
RM 55 Are staff oriented and trained annually on PHI and if so, how often?
RM 56 Is there a process in place to “de-identify” PHI?
RM 57 Is there a policy in place that requires the program not to use either a participant’s SS# or their HIC# as a medical record number?
Info Source
Key Points
Participant Health Outcomes Data Owner / Self-Assessment
Lead Met / Not Met Met w/Note
Requirement Add Note
Yes / No
PH 1 Have you identified a core set of quality measures for your PACE organization? (i.e., emergency department visits, weight gain or loss, immunization rates)
PH 2 Is your health information system designed to collect outcomes data?
PH 3 Do you collect, integrate, analyze and report data and measure performance?
PH 4 Is a single staff member responsible for maintaining the QAPI system and plan?
PH 5 Do you have a process for reviewing quality reports, designing quality improvement activities based on the data, and providing feedback about quality performance to program staff?
PH 6 Do you ensure that your report required elements to CMS and SAA in the manner and time intervals required?
PH 7 Can you provide a list of all of the data and information pertaining to the quality of participant care that your program reports, including the manner and time intervals of reporting. and SAA?
PH 8 Can you indicate those data that are required to be reported by CMS?
Info Source
Key Points
Medical Records Owner / Self-Assessment
Lead Met / Not Met Met w/Note
Requirement Add Note
Yes / No
HR 1 Is each record readily accessible?
HR 2 Is each record systematically organized?
HR 3 Is each record available to all staff?
HR 4 Is each record housed at the center?
HR 5 Do you have a process for periodic re-assessment to assure that your medical record continues to meet these requirements?
HR 6 If your medical record is electronic, does it assure signed, secure computer entry by a unique identifier of primary author?
HR 7 If your medical record is electronic, does it assure appropriate identifying information?
HR 8 If your medical record is electronic, does it assure documentation of all services furnished, including emergency care, inpatient or LTC services, services provided by center employees
and contractors, and contractor reports?
HR 9 If your medical record is electronic, does it assure assessment, reassessment, plan of care treatments, progress notes, and updates to the plan of care to reflect collaborative care planning
with residential and other health care settings?
HR 10 If your medical record is electronic, does it assure historical medical records?
HR 11 If your medical record is electronic, does it assure hospital discharge summaries?
HR 12 If your medical record is electronic, does it assure  documentation of IDT contact with informal support?
HR 13 If your medical record is electronic, does it assure enrollment agreement?
HR 14 If your medical record is electronic, does it assure physician orders?
HR 15 If your medical record is electronic, does it assure advance directives?
HR 16 If your medical record is electronic, does it assure signed release permitting disclosure of PHI?
HR 17 Do your records show documentation of prompt transfer of medical record copies upon request with release?
Info Source
Key Points
PACE Program Self-Assessment Tool
CLARIFICATIONS

Question Clarifications Redirect

PRS 12 Training plan should include: PRS 12
A timeline for training all existing staff
Records of mandatory attendance by all staff
PRS 13 Program should include: PRS 13
The skills listed that are necessary for the personal care attendent
How each of the skills listed will be tested to determine the PCA's competencey
Who is responsible in the PO for determining competency of the PCAs

ENV 4 Written plan must identify equipment, identify how manufacturer's recommendations will be used, who is responsible for ENV 4
maintaining the equipment and record keeping, procedures to report device related death and serious injuries to FDA and/or the manufacturer

ENV 13 It is important to remove broken equipment from its designated area and place signage on it to inform staff that its not to be used. ENV 13

TRS 1 Be aware that auditors may want to ride the transportation van and observe how participants are TRS 1
secured and safely transported.

DTY 1 Ensure policy addreses safe food delivery, emergency food supplies, nutritional adequacy of your menus to DTY 1
ensure that the participants' nutritional needs are ment - which includes - parental and integral
nutrition and home environment.

SDY 5 Plan for handling emergency care must contain hold-harmless clause for CMS and the state SDY 5

SDY 6 Be certain that your organization clearly communicates to participants that they are NOT required to call SDY 6
the center or on-call services after hours for an emergency. This should be clearly stated in materials
provided to participants.

RM 19 Medicare Part D requires records to be retained for 10 years, since Medicare part D information is contained in the participant’s medical record a retention period of 10 years is required. RM 19
PACE Program Self-Assessment Tool
MET WITH NOTE (Clinical - Administrative - Ad Hoc Elements)
Clinical Elements Redirect
PRS 02 PRS 02
Note:

PRS 04
Note: PRS 04

ENV 01
Note: ENV 01

ENV 02
Note: ENV 02

TRS 01
Note: TRS 01

DTY 01
Note: DTY 01

SDY 01
Note: SDY 01

SDY 02
Note: SDY 02

SDY 03
Note: SDY 03

SDY 04
Note: SDY 04

SDY 05
Note: SDY 05

QAP 04
Note: QAP 04

Administrative Elements
CTS 01
Note: CTS 01

FIN 01
Note: FIN 01

PRT 04
Note: PRT 04

PRT 06
Note: PRT 06

PRT 07
Note: PRT 07

PRT 08
Note: PRT 08

MKT 03
 Note: MKT 03

MKT 08 MKT 08
Note:

MKT 09
Note: MKT 09

Ad Hoc Elements
RM
Note: RM

PH
Note: PH

HR
Note: HR