CMS-10630 PACE Audit Process and Data Request Protocol

OMB Control Number: 0938-TBD (Expires: TBD)

Programs of All-Inclusive Care
for the Elderly (PACE)
AUDIT PROCESS AND DATA REQUEST

Programs of All-Inclusive Care for the Elderly (PACE)
AUDIT PROCESS AND DATA REQUEST
Table of Contents
Audit Purpose and General Guidelines .................................................................................................. 3
Universe Preparation & Submission ...................................................................................................... 5
Audit Elements ....................................................................................................................................... 8
I.

Service Delivery Requests, Appeals and Grievances (SDAG) ................................................... 8

II. Clinical Appropriateness & Care Planning ............................................................................... 11
III. Personnel Records ..................................................................................................................... 13
IV. Onsite Review ........................................................................................................................... 14
V. Quality Assessment ................................................................................................................... 16
Appendix .............................................................................................................................................. 18
Appendix A—Programs of All-Inclusive Care for the Elderly (PACE) Record Layouts ................ 18
Table 1: Service Delivery Requests (SDR) Record Layout ......................................................... 18
Table 2: Appeal Requests (AR) Record Layout .......................................................................... 20
Table 3: Grievance Requests (GR) Record Layout ...................................................................... 22
Table 4: List of Personnel (LOP) Record Layout......................................................................... 23
Table 5: List of Participant Medical Records (LOPMR) Record Layout ..................................... 24
Table 6: Quality Assessment Initiatives Records (QAIR) Record Layout ................................... 27
Table 7: On-Call Universe (OCU) Record Layout ....................................................................... 29

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Audit Purpose and General Guidelines
1. Purpose: To evaluate performance in the five areas outlined below related to the Programs of
All-Inclusive Care for the Elderly (PACE). The Centers for Medicare and Medicaid Services
(CMS) will perform its audit activities using these instructions (unless otherwise noted).
2. Review Period: The review period will be one year preceding the date of the audit engagement
letter. CMS reserves the right to expand the review period to ensure sufficient universe size.
3. Responding to Documentation Requests: The PACE organization (PO) is expected to present
any supporting documentation requested during the audit and upload the supporting
documentation, as requested, to the secure site using the designated naming convention and
within the timeframe specified by the CMS Audit Team.
4. Pre-Audit Disclosed Issues of Non-Compliance: POs will be asked to provide a list of all
disclosed issues of non-compliance that are relevant to the elements being audited and may be
detected during the audit. A disclosed issue is one that has been reported to CMS prior to the
receipt of the audit start notice (which is also known as the “engagement letter”). Issues identified
by CMS or the SAA through on-going monitoring or other account management/oversight
activities during the audit year are not considered disclosed. POs should exclude Level I and
Level II data already reported to CMS.
POs must provide a description of each disclosed issue as well as the status of correction and
remediation using the Pre-Audit Issue Summary template (Attachment III). This template is due
within 5 business days after the receipt of the audit start notice. The PO’s Account Manager will
review Attachment III to validate that “disclosed” issues were known to CMS prior to receipt of
the audit start notice.
When CMS determines that a disclosed issue was promptly identified, corrected (or is actively
undergoing correction), and the risk to participants has been mitigated, CMS will not apply the
ICAR condition classification to that condition.
5. Impact Analysis (IA): An impact analysis must be submitted as requested by CMS. The impact
analysis must identify all participants subjected to or impacted by the issue of non-compliance.
POs will have up to 10 business days to complete the requested impact analysis templates. CMS
may validate the accuracy of the impact analysis submission(s). In the event an impact analysis
cannot be produced, CMS will report that the scope of non-compliance could not be fully
measured and impacted an unknown number of participants within the PO.
6. Calculation of Score: CMS will determine if each condition cited is an Observation (0 points),
Corrective Action Required (CAR) (1 point) or an Immediate Corrective Action Required (ICAR)
(2 points).
CMS will then add all of the points (CARs and ICARs) from the audit and then divide that
number (i.e., total score), by the number of audit elements (i.e., 5 audit elements) tested to
determine the PO’s overall PACE audit score. Observations will be recorded in the draft and final
reports, but will not be scored and therefore will not be included in the audit scores.
7. Informing PO of Results: CMS will provide daily updates regarding conditions discovered that
day (unless a sample has been pended for further review). CMS will provide a preliminary
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summary of the conditions at the exit conference. The CMS Audit team will do its best to be as
transparent and timely as possible in its communication of audit findings. POs will also receive a
draft audit report which they may formally comment on and then a final report will be issued after
consideration of a PO’s comments on the draft.

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Universe Preparation & Submission
1. Responding to Universe and Documentation Requests: The PO is expected to provide
accurate and timely universe and documentation submissions within 30 calendar days of the
engagement letter date. CMS may request a revised universe if data issues are identified.
2. Pull Universes and Submit Documentation: The universes and documentation collected test
whether the PO has deficiencies related to the 5 audit elements: personnel records, service
delivery requests, appeals and grievances (SDAG), clinical appropriateness and care planning
(care planning, participant assessments, IDT requirements, etc.), quality assessment and an onsite
review.
2.1. Documentation: POs should submit the following documentation in Microsoft Word
(.docs), Microsoft Excel (.xlsx) or Portable Document File (PDF).
•
•
•

Completed PACE Supplemental Questions (Attachment II)
The PO’s Quality Assessment and Performance Improvement (QAPI) plan(s) that were in use
during the audit review period
Participant Advisory Committee (PAC) Minutes for the audit review period

2.2. Data Universes: POs will provide universes of all of their service delivery requests, all
appeals, all grievances, as well as a universe of any quality initiatives and quality data during
the audit period. Additionally, POs will provide a universe of all personnel employed during
the audit review period, as well as a universe of all participants enrolled during the audit
review period.
•
•
•
•
•
•
•

Table 1:
Table 2:
Table 3:
Table 4:
Table 5:
Table 6:
Table 7:

Service Delivery Requests (SDR)
Appeal Requests (AR)
Grievance Requests (GR)
List of Personnel (LOP)
List of Participant Medical Records (LOPMR)
Quality Assessment Initiatives Records (QAIR)
On-call Universe (OCU)

For the service delivery request, appeal and grievance universes, cases that fall in the review
period should be submitted based on the date the request/ grievance was processed/ resolved (or
should have been processed/ resolved). The date the request or grievance was received may fall
outside of the review period.
For the quality assessment universe, the PO should identify each quality initiative that occurred
and the corresponding data used in the quality initiative during the audit review period. A quality
initiative is a set of data used to measure and identify areas of good or problematic performance
within a PACE organization. Data could include examples such as hospitalizations, falls,
grievances, appeals, medical records, audits, etc.
For the personnel universe, the PO should include all personnel who were employed at any time
during the audit review period. This should include part-time employees, full-time employees,
contract employees, volunteers, and temporary employees. The PO does not need to submit the

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actual personnel record for each employee, only the information identified in Appendix A Table
4.
For the participant medical record universe, the PO should include all participants who were
enrolled at some point during the review period. This will include participants who were enrolled
prior to the audit review period who disenrolled during the audit review period, as well as
participants who enrolled during the audit review period. The PO does not need to submit
medical records for each participant, only the information identified in Appendix A Table 5.
For the on-call universe, POs must submit all information relating to all calls received after hours
by the PO.
The universes should be 1) all inclusive, regardless of whether the request was determined to be
approved, denied, or partially denied and 2) submitted in the appropriate record layout as
described in Appendix A.

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3. Submit Universes to CMS: POs should submit each universe in the Microsoft Excel (.xlsx) file
format with a header row following the record layouts shown in Appendix A, Tables 1-7. CMS
will run the tests indicated below on the first 3 universes. For the notification timeliness tests,
auditors will determine the percentage of timely cases from a full universe of approvals and
denials.
TABLE
#

RECORD
LAYOUT

UNIVERSE

APPLICABLE

1

SDR

Service
Delivery
Requests

SDAG

2

AR

Appeal
Requests

SDAG

3

GR

Grievance
Requests

SDAG

AUDIT
ELEMENT

COMPLIANCE
STANDARD TO APPLY

CFR REF.

No later than 72 hours
following the date the
request was received
by the IDT. The PO
may extend the
decision up to 5 days
when applicable.
No later than 30 days
from the date of
receipt for standard
appeals. No more
than 72 hours from
receipt of the appeal
for expedited appeals.

460.104(d)(2)
(ii) and
460.104(d)(2)
(iii)

Notification

460.122(c)(5)
and (f)(2)

Notification

A PO must determine
the timeframe for
resolving grievances
in their internal
policies and
procedures.

460.120(c)(3)

Notification

TEST

4. Selecting Samples: Auditors will review the universes collected from the PO and select samples
in accordance with the instructions noted below. For each element, the selected samples will be
given to the PO 1 business day before the review of that element begins.

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Audit Elements
I. Service Delivery Requests, Appeals and Grievances (SDAG)
1. Select Sample Cases: In sampling, CMS will select 30 targeted cases that appear significant.
CMS will attempt to ensure that the sample set is representative of various types of service
requests, grievances and appeals. CMS will use the PAC Minutes, the On-Call Universe and the
List of Participant Medical Records in order to target samples for review. The sample set will be
selected from the universe categories as follows:
•
•
•
•

10 service delivery request denials
5 service delivery request approvals
5 appeal request denials
10 grievances

2. Review Sample Case Documentation: CMS will review all sample case file documentation to
ensure the PO followed all procedures appropriately, including identifying the request, processing
the request, notifying participants timely and appropriately, and providing any approved services.
The PO will need to provide access to the following documents during the audit (either onsite or
through a live webinar):
2.1. For service delivery requests:
• Initial request:
 Copy of the initial request (received in writing, orally, etc.)
 If request was received via phone, any call notes taken that document the call.
• Copy of all case notes for an assessment if it is conducted and/or any progress notes.
• Copy of any decisions made based on the assessment.
• Copy of all letters or notifications regarding the decision.
• Documentation of the decision, including:
 Documentation showing denial, partial denial, or approval notification to the
participant and/or their caregiver, if applicable.
• Copy of the written decision letter
• For oral notification, copy of medical record notes and/or documentation of call.
• Any other reports, system notes, or logs that document denial or approval of the request
and participant notification.
• For denials, documentation that appropriate appeal rights were given.
• For approvals, documentation of service or care being provided, including an annotation
in the participant’s medical record, assessments, progress notes, and care plan.
• If applicable, documentation regarding any extension that was taken including the reason
for the extension and who requested the extension.
2.2. For appeals:
• Initial appeal request:
 Copy of the appeal request (received in writing, orally, etc.)
 If request was received via phone, any call notes taken that document the call.
• Copy of all case notes involving the appeal.
• Copy of any decisions made based on the appeal and any assessments done.
• Copy of all letters or notifications regarding the decision.
• Documentation of who conducted the review of the appeal.
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•
•
•
•
•
•
•
•
•
•
•

Documentation that the participant was given an opportunity to present evidence.
Documentation of why a plan expedited an appeal (if applicable).
Documentation of why a plan extended the appeal (if applicable).
Documentation of the decision, including:
 Documentation showing denial, partial denial, or approval notification to the
participant and/or their caregiver, if applicable.
Copy of the written decision letter
Documentation showing parties that received the decision letter (CMS, SAA, etc.)
For oral notification, copy of PO notes and/or documentation of call.
Any other reports, system notes, or logs that document denial or approval of the request
and participant notification.
For denials, documentation that appropriate appeal rights were given.
For approvals, documentation of service or care being provided, including an annotation
in the participant’s medical record.
If applicable, documentation regarding any extension that was taken including the reason
for the extension and who requested the extension.

2.3. For grievances:
• Initial complaint/ grievance:
 If complaint was received via fax/mail/email, copy of original complaint.
 If request was received via phone, copy of PO notes and/or documentation of call
including call details.
• Documentation explaining the grievance issue(s).
• Copy of all supplemental information submitted by the participant and/or their caregiver.
 If information was received via fax/mail/email, copy of documentation provided.
 If information was received via phone, copy of medical record notes and/or
documentation of call.
• Documentation showing the steps the PO took to resolve the issue, including appropriate
correspondence with other departments within the organization and description of the
final resolution.
• Documentation showing the PO continued providing care through the grievance process,
as appropriate.
• Documentation showing resolution notification to the participant and/or their
representative.
 Copy of the written resolution letter sent and documentation of date/time letter was
mailed.
 If oral notification was given, copy of medical record notes and/or other
documentation of call including the date.
3. Apply Compliance Standard: At a minimum, CMS will evaluate cases against the following
criteria. CMS may review factors not specifically addressed in these questions if it is determined
that there are other related SDAG requirements not being met.
3.1 Did the PO appropriately process service delivery requests, appeals and grievances?
3.1.1 Did the PO appropriately identify and classify requests, appeals and/ or grievances?
3.1.2 Did the PO use the appropriate personnel in reviewing requests and/or appeals?
3.1.3 Was a service delivery assessment conducted in person?
3.1.4 Did the PO provide the participants with a reasonable opportunity to present evidence
during their appeals?
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3.1.5
3.1.6

Did the PO properly identify and address all issues in a grievance?
Did the PO continue to provide disputed care to a Medicaid participant?

3.2 Did the PO appropriately notify participants and/or caregivers of any decision relating
to a service delivery request, appeal or grievance?
3.2.1 Did the service delivery oral and written denial notification include the specific
reason for the denial in a clear and understandable manner?
3.2.2 Did the oral and written service delivery denial notification include the right to
appeal?
3.2.3 Did the PO notify all parties of an adverse appeal decision?
3.2.4 Did the PO notify the participant of the grievance outcome?
3.3 Did the PO timely resolve/ issue a decision on a service delivery request, appeal and/or
grievance?
3.3.1 Did the PO notify the participant within 72 hours of the IDT receiving the request for
assessment/ reassessment?
3.3.2 Did the PO appropriately extend the timeframe of a service delivery request, if
applicable?
3.3.3 Did the PO process an appeal within 30 days, or, for expedited appeals, within 72
hours after the PO receives the appeal?
3.3.4 Did the PO appropriately extend the timeframe of the expedited appeal, if applicable?
3.3.5 Did a PO timely process a grievance?
3.3.6 Did the PO effectuate approved service delivery requests and appeals?
4. Sample Case Results: CMS will test each of the 30 cases. If CMS requirements are not met,
conditions (findings) are cited. If CMS requirements are met, no conditions (findings) are cited.
NOTE: Cases and conditions may have a one-to-one or a one-to-many relationship. For example,
one case may have a single condition or multiple conditions of non-compliance.

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II. Clinical Appropriateness & Care Planning
1. Select Sample Cases: In sampling, CMS will select 10 targeted medical records that appear
clinically significant. CMS will attempt to ensure that the sample set is representative of various
types of service requests and care (e.g., hospitalizations, wound care, dialysis, social needs, home
bound, skilled nursing, etc.). CMS will also utilize the SDAG universes, the On-Call Universe,
and the PAC minutes in order to appropriately target participants.
2. Review Sample Case Documentation: CMS will review all medical records for proper
documentation of all relevant processes related to participant care planning. The PO will need
access to the following documents during the audit and may be requested to produce screenshots
of any of the following:
•

•

•

•

•
•
•

All documentation related to participant assessments:
 Initial comprehensive assessment conducted,
 All annual, semi-annual, and ad-hoc assessments,
 IDT responsible for conducting assessments,
 Documentation related to outcome of assessments, changes in care plans, or any
other related resolution,
 Documentation that assessments were done in person.
All documentation related to the participant’s care plan:
 When and how the care plan was developed,
 All changes made to the care plan at any point,
 Progress notes, treatments, evaluations, of the care plan,
 IDT recommendations and notes related to the care plan,
 Assessments that were used in constructing or revising the care plan,
 Documentation that the participant was appropriately involved in making the care
plan.
All documentation related to service delivery and emergency care:
 Documentation that the PO is providing all medically necessary services and care as
determined by the IDT,
 Documentation that the PO is providing any Medicare/ Medicaid covered services as
appropriate,
 Documentation that the PO is providing comprehensive PACE services to
participants, including social, physical therapy, medical, etc.
 Documentation that shows there was an on-call provider available to participants 24
hours a day.
 Documentation showing the PO provided immediate access to emergency care,
 Any documentation of emergency care, including that the participant was held
harmless,
 Any documentation relating to the use of restraints, if applicable.
Documentation relating to the interdisciplinary team (IDT) including:
 Documentation that the IDT consists of all requisite members,
 Documentation showing all required members were involved in assessments and care
planning as appropriate,
 Documentation of any communications by the IDT.
All other documentation related to a participants experience or care at the PACE
organization.
Any documentation relating to the participants dietary needs,
Any documentation relating to a participants attendance at the PACE center.

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3. Apply Compliance Standard: At a minimum, CMS will evaluate cases against the following
criteria. CMS may review factors not specifically addressed in these questions if it is determined
that there are other related PACE requirements not being met.
3.1 Did the PO provide adequate care/ services to the participants (including but not
limited to transportation, dietary, medical care, etc.)?
3.1.1 Did the PO furnish mandatory services at the PACE center?
3.1.2 Did the PO provide appropriate services and care? Did the PO provide
immediate access to emergency services?
3.1.3 Did the PO provide access to care/ services 24 hours a day as necessary?
3.2 Did the PO ensure that the IDT was appropriately involved in the participants’
care?
3.2.1 Has the PACE organization appropriately established an interdisciplinary
team at each PACE center?
3.2.2 Did the IDT appropriately document assessments, care plans, and care
coordination in the medical record?
3.2.3 Is there evidence that members of the IDT remain alert to pertinent input
from other team members, participants, and caregivers?
3.3 Did the PO perform assessments as required?
3.3.1 Did the PO perform assessments as required in a timely manner (annual,
semi-annual, or more frequently when necessary)?
3.3.2 Did the PO ensure the appropriate IDT members performed assessments?
3.3.3 Were all required assessments conducted in-person?
3.4 Did the PO keep an accurate and appropriate medical record?
3.4.1 Did the PO maintain a single, comprehensive medical record?
3.4.2 Did the PO maintain a medical record that was complete, accurately
documented, readily accessible, systematically organized and available to all
staff?
3.5 Did the PO develop and document an appropriate care plan for the participants?
3.5.1 Did the PO promptly and appropriately develop a care plan that meets the
minimum requirements for each participant?
3.5.2 Did the PO appropriately evaluate and monitor the participants’ care plan?
3.5.3 Did the PO ensure that the appropriate IDT members were involved in
creating the care plan?
3.5.4 Was an explanation of care plan changes given to the participant?
3.5.5 Did the participant have a role in care plan decisions?
4. Sample Case Results: CMS will test each of the 10 medical records. If CMS requirements are
not met, conditions (findings) are cited. If CMS requirements are met, no conditions (findings)
are cited. NOTE: Cases and conditions may have a one-to-one or a one-to-many relationship. For
example, one case may have a single condition or multiple conditions of non-compliance.
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III.

Personnel Records

1. Select Sample Cases: CMS will select a targeted sample of 10 personnel records. CMS will
attempt to ensure that the sample set is representative of various types of employees, including
part-time, full-time, contract, volunteers, etc.
2. Review Sample Case Documentation: CMS will review all sample case file documentation to
determine that the personnel records contain all required materials. The PO will need to produce
the following documents during the audit and may be requested to produce screenshots or copies
of any of the following:
•
•
•
•
•
•

Documentation in the personnel file of all required trainings given to employees,
Documentation of any competencies given,
Documentation of any and all background checks conducted,
Documentation of OIG excluded provider checks being conducted,
Employee health records, including:
 Immunizations (either provided or offered),
 Any physicals administered
Documentation of Licensure required for the position

3. Apply Compliance Standard: At a minimum, CMS will evaluate cases against the following
criteria. CMS may review factors not specifically addressed in these questions if it is determined
that there are other related PACE requirements not being met.
3.1 Did the PO personnel have the appropriate licensures?
3.2 Did the PO conduct an OIG exclusion check for personnel?
3.3 Did the PO run a background check on personnel?
3.4 Did the PO ensure that all staff with direct participant contact were medically cleared
for communicable diseases and have all immunizations up-to-date before engaging in
direct participant contact?
3.5 Did the PO provide trainings and/or competencies, as appropriate, for personnel?
3.5.1 Were competency evaluations done for individuals performing participant care?
3.5.2 Was OSHA training provided?
3.5.3 Were ongoing trainings provided to personnel?
3.5.4 Did staff receive appropriate emergency training?
4. Sample Case Results: CMS will test each of the 10 files. If CMS requirements are not met,
conditions (findings) are cited. If CMS requirements are met, no conditions (findings) are cited.
NOTE: Cases and conditions may have a one-to-one or a one-to-many relationship. For example,
one case may have a single condition or multiple conditions of non-compliance.

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IV.

Onsite Review

1. Select Participants for Observation: CMS will observe 3 to 5 participants while onsite,
including at least one who receives care from home and one who receives care at the center.
CMS may observe more participants while onsite if an issue is noted that warrants additional
review. In addition to selecting participants to observe, CMS will do an onsite inspection of at
least one transportation vehicle and check for specific emergency equipment available at the
PACE organization.
2. Review Sample Case Documentation and Observations: The PO should be able to provide the
following access to CMS auditors:
•
•
•
•
•
•

A private area (can be the clinic) to view a willing participant receiving care,
A home visit of a willing participant,
A visit to an outside facility (such as a SNF), if applicable,
At least one transportation vehicle used to transport participants to and from the center,
Any emergency equipment the center has available.
An IDT meeting for CMS observation.

3. Apply Compliance Standard: At a minimum, CMS will evaluate the onsite review portion of
the audit against the following criteria. CMS may review factors not specifically addressed in
these questions if it is determined that there are other related PACE requirements not being met.
3.1 Does the PO have a method of communicating between the van and the PACE center?
3.2 Does the PO have a method of providing safe transportation to participants?
3.2.1 Did the PO have a demonstrated method for securing participants (i.e., seat belts) and
securing DME (e.g., wheelchairs, oxygen, walkers)?
3.3 Did the PO appropriately communicate regarding the participant’s care plan?
3.3.1 Has the PO appropriately established an IDT at each PACE center?
3.3.2 Is there evidence that members of the IDT remain alert to pertinent input from other
team members, participants, and caregivers?
3.3.3 Was an explanation of care plan changes given to the participant?
3.3.4 Did the IDT collaborate with the participant and/or caregiver in care plan
development?
3.4 Did the PO adhere to an individual's care plan when providing care/ services?
3.4.1 Did the PO provide services or care as identified in the care plan?
3.4.2 Did the PO provide treatment or medications as identified in the care plan?
3.5 Does the PO follow appropriate infection control standards when providing care?
3.5.1 Did personnel wash/ sanitize hands as appropriate?
3.5.2 Did personnel don and doff personal protective equipment as appropriate?
3.6 Does the PO have emergency equipment available (suction, oxygen, medications, etc.)?
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3.7 Does the PO appropriately document changes, progress notes, and/or treatment in the
care plan and any evidence that these changes/ treatments were implemented?
3.7.1 If a change in the care plan was identified, was it appropriately documented?
3.7.2 If treatment was rendered, was that appropriately documented?
3.7.3 During an assessment or treatment, were progress notes appropriately documented?
3.7.4 Did the care plan identify measureable outcomes to be achieved?
3.8 Does the PO follow dietary care plans by providing food in the form necessary for
participant’s needs?
3.8.1 If the care plan identifies the participant as needing a particular type of meal (pureed,
etc.), does that participant actually receive that meal?
4. Onsite Review Results: CMS will conduct onsite observations. If CMS auditors determine that
requirements are not met while conducting the onsite review, conditions (findings) are cited. If
CMS requirements are met, no conditions (findings) are cited.

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V.

Quality Assessment

1. Select Sample Cases: CMS will select two tracers, using the Quality Assessment Initiatives
Records universe, appeals and grievances documentation, onsite interviews and discussions with
the PO, a review of participant medical records, etc. to determine the effectiveness of the POs
quality assessment and performance improvement (QAPI) program. A “tracer” is a quality
initiative, participant outcome, issue, event, trend, etc. that is used to assess compliance with
different aspects of the quality program. For example, if there is an issue related to a particular
participant hospitalization, auditors may use the hospitalization to assess the PO’s identification,
correction and follow-up (e.g., possible training/ process improvement) related to that event.
Likewise, if the PO identifies reduction of hospital utilization in its QAPI plan, auditors may use
hospitalization data from the review period to assess the effectiveness of the QAPI program.
2. Review Tracer Case Documentation: CMS will review all relevant documentation and
information related to the tracer. The PO will need to produce the following documents during
the audit and may be requested to produce screenshots or copies of any of the following:
•
•
•
•
•
•
•
•
•

Overview of the quality initiative, identified issue or concern
Detailed explanation of the quality initiative(s), issue(s) (e.g., what the PO found, when
the PO first learned about the issue, the root cause, and who or which personnel were
involved.)
Root cause analysis that determined what caused or allowed the issue, problem or
deficiency to occur, if applicable
Specific actions taken in response to the detected issue(s), if applicable
Documentation of communication to staff regarding the issue
Processes and procedures revised in response to becoming aware of the issue(s), if
applicable
Any internal monitoring that was implemented as a result of corrective actions being
taken, if applicable
Timeframes related to the quality initiatives or issues, root cause analyses, or corrective
actions
Staff members and contractors involved in the QAPI activities

3. Apply Compliance Standard: At a minimum, CMS will evaluate the two tracers against the
following criteria. CMS may review factors not specifically addressed in these questions if it is
determined that there are other related PACE requirements not being met.
3.1. Did the PO develop and/ or implement an effective, data driven quality assessment and
performance improvement program?
3.1.1. Did the PO appropriately develop and implement outcome measures?
3.1.2. Did the PO appropriately identify and implement corrective action when identifying a
quality issue?
3.2. Did the PO ensure that the appropriate staff were involved in the development and
implementation of QAPI activities?
4. Sample Case Results: CMS will use the tracers to assess whether CMS requirements are met. If
CMS requirements are not met, conditions (findings) are cited. If CMS requirements are met, no
conditions (findings) are cited. NOTE: Cases and conditions may have a one-to-one or a one-to-

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many relationship. For example, one case may have a single condition or multiple conditions of
non-compliance.

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Appendix
Appendix A—Programs of All-Inclusive Care for the Elderly (PACE) Record Layouts
The universes for the PACE program area must be submitted as a Microsoft Excel (.xlsx) file with a
header row. Do not include additional information outside of what is dictated in the record layout.
Please use a comma (,) to separate multiple values within one field if there is more than one piece of
information for a specific field.
NOTE: There is a maximum of 4,000 characters per record row. Therefore, should additional
characters be needed for a variable, enter this information on the next record at the appropriate start
position.
Table 1: Service Delivery Requests (SDR) Record Layout
• Include all requests processed as service delivery requests.
• Submit cases based on the date the PO’s decision was rendered or should have been rendered
(the date the request was initiated may fall outside of the review period).
Column
ID
A

Field Name

Field Type

Participant First Name

B

Participant Last Name

C

Participant ID

D

Person who submitted
the Service Request

E

Date Service Delivery
Request Received

F

Category of the Request

G

Description of the
Request

H

Date(s) assessment(s)
performed

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Page 18 of 29

Field
Length
50

Description

50

Last name of the participant.

25

The identification number the PO uses to
identify the participant.

30

Provide the person who submitted the service
request. Valid fields include: participant,
caregiver, IDT, other.
Date the service delivery request was received
by the interdisciplinary team (IDT). Submit in
CCYY/MM/DD format (e.g., 2017/01/01).
Provide the category or type of service
delivery request. Examples include: Center
days, eye wear, dental, home care, etc.
Provide a description of the issue and, for
denials, an explanation of why the decision
was denied.
Provide the date(s) that the assessment(s) was
performed by the appropriate personnel or
disciplines (IDT members) for the service
request. If more than one date, enter all dates
separated by a comma. Submit in
CCYY/MM/DD format (e.g., 2017/01/01).
Enter NA if an assessment was not conducted.

10

50

1000

80

First name of the participant.

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Column
ID
I

Field Name

Field Type

Discipline(s)
performing
assessment(s)

CHAR
Always
Required

J

Assessment(s) In
Person

2

K

Request Disposition

L

Extension

M

Date of Oral
Notification

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

N

Date of Written
Notification

CHAR
Always
Required

10

O

Date service provided

CHAR
Always
Required

10

Page 19 of 29

Field
Length
100

16

1

16

Description
Provide the disciplines of the personnel
involved in performing any of the assessments
for this service request. If more than one
discipline, include all applicable separated by
commas. Enter NA if an assessment was not
conducted.
Yes (Y)/ No (N) indicator on whether all the
assessments were done in person. Enter NA if
an assessment was not conducted.
Provide the request disposition for the service
delivery request. Valid fields include:
Approved, Denied or Partially Denied.
Yes (Y) / No (N) indicator on whether an
extension was taken.
Date the PO provided oral notification of the
decision to the participant or caregiver.
Submit in CCYY/MM/DD format (e.g.
2017/01/01). Enter NA if no oral notification
was provided.
Date the PO provided written notification of
the decision to the participant or caregiver.
Submit in CCYY/MM/DD format (e.g.
2017/01/01). Enter NA if no written
notification was provided.
Date the approved service was provided to the
participant. Submit in CCYY/MM/DD format
(e.g. 2017/01/01). Enter NA if the request was
denied.

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Table 2: Appeal Requests (AR) Record Layout
• Include all requests processed as standard or expedited appeals received by the PACE
organization.
• Submit cases based on the date the PO’s decision was rendered or should have been
rendered (the date the request was initiated may fall outside of the review period).
Column
ID
A

Field Name

Field Type

Participant First Name

B

Participant Last Name

C

Participant ID

D

Person who submitted
the Appeal

E

Date Appeal Received

F

Time Appeal Received

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

G

Expedited

H

Extension

I

Category of the Appeal

J

Description of the
Appeal

K

Request Disposition

L

Date of Oral
Notification

M

Time of Oral
Notification

Page 20 of 29

Field
Length
50

Description

50

Last name of the participant.

25

The identification number the PO uses to
identify the participant.

30

Provide the person who submitted the
appeal. Valid fields include: participant,
caregiver, IDT, other.
Provide the date the appeal was received
by the PO. Submit in CCYY/MM/DD
format (e.g., 2017/01/01).
Provide the time the appeal was received
by the PO. Submit in HH:MM format
(e.g. 23:54). Enter NA for an appeal that
was not expedited.
Yes (Y) / No (N) indicator on whether the
appeal was expedited.

10

5

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

1

CHAR
Always
Required

5

First name of the participant.

1

Yes (Y) / No (N) indicator on whether the
PO took an extension on the appeal.

50

Provide the category or type of appeal
request. Examples include: Center days,
eye wear, dental, home care, etc.
Provide a description of the issue and, for
denials, an explanation of why the appeal
was denied.
Provide the request disposition for the
appeal. Valid fields include: Approved,
Denied or Partially Denied.
Date the PO provided oral notification of
the decision to the participant or caregiver.
Submit in CCYY/MM/DD format (e.g.
2017/01/01). Enter NA if no oral
notification was provided.
Time the PO provided oral notification of
the decision to the participant or caregiver.
Submit in HH:MM format (e.g. 23:59).
Enter NA if no oral notification was
provided or if the request was not
expedited.

1000

16

16

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Column
ID
N

Field Name

Field Type

Date of Written
Notification

CHAR
Always
Required

O

Time of Written
Notification

CHAR
Always
Required

5

P

Date Service Provided

CHAR
Always
Required

10

Q

Quality Analysis

CHAR
Always
Required

1

Page 21 of 29

Field
Length
10

Description
Date the PO provided written notification
of the decision to the participant or
caregiver. Submit in CCYY/MM/DD
format (e.g. 2017/01/01). Enter NA if no
written notification was provided.
Time the PO provided written notification
of the decision to the participant or
caregiver. Submit in HH:MM format (e.g.
23:59). Enter NA if no written
notification was provided or if the request
was not expedited.
If the appeal was approved at any level of
the process, provide the date the service
was provided to the participant. Submit in
CCYY/MM/DD (e.g., 2017/01/01). Enter
NA if the appeal was not approved or if
the service has not been provided yet.
Yes (Y) / No (N) indicator on whether an
analysis of this particular appeal was
included in your QAPI program?

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Table 3: Grievance Requests (GR) Record Layout
• Include all complaints processed as grievances.
• Submit grievances based on the date the PO’s decision was rendered or should have been
rendered (the date the complaint was initiated may fall outside of the review period).
Column
ID
A

Field Name

Field Type

Field Length

Description

Participant First Name

50

First name of the participant.

B

Participant Last Name

50

Last name of the participant.

C

Participant ID

25

The identification number the PO uses to
identify the participant.

D

Person who submitted
the Grievance

30

E

Date Grievance
Received

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

F

Category of the
Grievance

CHAR
Always
Required

50

G

Description of the
Grievance

1000

H

Grievance Resolution

I

Date of Resolution

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Provide the person who submitted the
grievance. Valid fields include:
participant, caregiver, other.
Provide the date the grievance was
received by the PO. Submit in
CCYY/MM/DD format (e.g.,
2017/01/01).
Provide the category or type of grievance.
Examples include: Personnel or staffing
issue, service delivery, dietary,
transportation, home care, etc.
Provide a description of the grievance.

J

Date of Oral
Notification

CHAR
Always
Required

10

K

Date of Written
Notification

CHAR
Always
Required

10

L

Quality Analysis

CHAR
Always
Required

1

Page 22 of 29

10

1

10

Yes (Y) / No (N) indicator on whether the
grievance is resolved (i.e., all issues have
been addressed).
Provide the date the grievance was
resolved (i.e., all issues addressed) by the
PO. Submit in CCYY/MM/DD format
(e.g., 2017/01/01). Enter NA if the
grievance has not been resolved.
Date of oral notification of the grievance
resolution. Submit in CCYY/MM/DD
format (e.g., 2017/01/01). Enter NA if no
oral notification was provided.
Date the written notification of the
grievance resolution was given to the
participant or caregiver. Submit in
CCYY/MM/DD format (e.g.,
2017/01/01). Enter NA if no written
notification was provided.
Yes (Y) / No (N) indicator on whether
an analysis of this particular grievance
was included in your QAPI program?

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Table 4: List of Personnel (LOP) Record Layout
• Include all personnel employed during the audit period (i.e., volunteer, part-time, full
time, and contract).
• Include any personnel hired during the audit period.
• Exclude all personnel terminated prior to the audit period.
Column
ID
A

Field Name

Field Type

Field Length

Description

Employee First Name

50

First name of the employee.

B

Employee Last Name

50

Last name of the employee.

C

Job Title

25

D

Job Description

Provide the job title of the employee.
Examples: Home health aide, physical
therapist, etc.
Provide a brief description of the job
duties.

E

Date of Hire

F

Date of Termination

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

G

Type of Employment

25

H

Direct Participant
Contact

I

License

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Page 23 of 29

50

10

10

1

2

Provide the date the employee was hired
by the PO. Submit in CCYY/MM/DD
format (e.g., 2015/01/01).
Provide the date the employee was
terminated from the PO. Submit in
CCYY/MM/DD format (e.g.,
2017/01/01). Enter NA if the employee
is still working for the PO.
Provide the type of employment for the
employee. Valid fields are: contract,
full-time, part-time, volunteer, other.
Yes (Y) / No (N) indicator of whether
the employee has direct participant
contact as a part of their job duties.
Yes (Y) / No (N) indicator of whether
the employee is licensed for their job
with the PACE organization. Enter NA
if the employee’s position for not
require a license.

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Table 5: List of Participant Medical Records (LOPMR) Record Layout
• Include all participants enrolled in the PO at some point during the audit period.
• Exclude all participants disenrolled prior to the audit period.
Column
ID
A

Field Name

Field Type

Field Length

Description

Participant First Name

50

First name of the participant.

B

Participant Last Name

50

Last name of the participant.

C

Participant ID

25

The identification number the PO uses to
identify the participant.

D

Date of Enrollment

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

10

E

Date of Disenrollment

CHAR
Always
Required

10

F

Reason for
disenrollment

100

G

Number of Hospital
Admissions/
Observations
Number of Emergency
Room Visits

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

CHAR
Always
Required
CHAR
Always
Required

1

CHAR
Always
Required

1

Provide the date the participant was
enrolled in the PO. Submit in
CCYY/MM/DD format (e.g.,
2015/01/01).
Provide the date the participant
disenrolled from the PO. Submit in
CCYY/MM/DD format
(e.g.2015/01/01). Answer NA if the
participant is still enrolled.
Provide the reason for the disenrollment.
Answer NA if the participant is still
enrolled.
Provide the number of hospital
admissions or observations that occurred
during the audit review period.
Provide the number of emergency room
visits that occurred during the audit
review period.
Provide the number of skilled nursing
facility/ nursing facility admissions that
occurred during the audit review period.
This should include all SNF/NF
admissions for any cause, including
admission as a result of a request for
services.
Yes (Y) / No (N) indicator on whether
the participant currently resides in a SNF
or NF?
Provide whether the participant received
home care during the audit review
period (either skilled or unskilled).
Valid Fields are: Skilled or Unskilled.
If the participant did not receive home
care during the audit review period enter
NA.
Yes (Y) / No (N) indicator on whether
the participant currently receives either
skilled or unskilled home care?

H

I

Number of SNF/NF
Admissions

J

Currently in SNF/NF

K

Received Home Care

L

Currently Receiving
Home Care

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3

3

3

10

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Column
ID
M

Field Name

Field Type

Field Length

Description

Current Center
Attendance

CHAR
Always
Required

1

N

Transportation
Services Provided

1

O

Number of Falls
reported as a Level II
event
Currently recovering
from a fall reported as
a Level II event

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Provide information on how often the
participant currently attends the center.
Enter the number of days each week
(e.g., 1, 3, 5).
Yes (Y) / No (N) indicator on whether
the PO provides transportation to the
participant?
Provide the number of falls a participant
had during the audit review period that
were reported as a Level II event.
Yes (Y) / No (N) indicator on whether
the participant is still recovering from a
fall that was reported as a Level II
event? Enter NA if the participant did
not have a fall reported as a Level II
event.
Provide the number of infections the
participant had during the audit review
period. This includes all types of
infections as defined by your infection
control plan. Enter NA if the participant
did not have an infection during the
audit review period.
Yes (Y) / No (N) indicator on whether
the participant has had one or more
pressure ulcer(s) during the audit review
period. Only include pressure ulcers
that are staged II or above.
Yes (Y) / No (N) indicator on whether
the participant is currently receiving
treatment for a pressure ulcer staged II
or above?
Yes (Y) / No (N) indicator on whether
the participant is currently experiencing
ongoing incontinence (either bladder or
bowel)?
Yes (Y) / No (N) indicator on whether
the participant had an indwelling
catheter during the audit review period?
Yes (Y) / No (N) indicator on whether
the participant experienced significant
unanticipated weight loss at any time
during the audit review period?
If the participant needed a mechanically
altered diet at any point during the audit
period, enter a description of the diet
(e.g., pureed, mechanical, etc.).
Yes (Y) / No (N) indicator on whether
the participant received parenteral or
enteral feeding at any point during the
audit period?

P

3

2

Q

Number of Infections

CHAR
Always
Required

3

R

Pressure Ulcers

CHAR
Always
Required

1

S

Currently receiving
treatment for pressure
ulcer

CHAR
Always
Required

1

T

Incontinent

CHAR
Always
Required

1

U

Indwelling Catheter

1

V

Significant Weight
Loss

CHAR
Always
Required
CHAR
Always
Required

W

Mechanically Altered
Diet

CHAR
Always
Required

100

X

Parenteral or Enteral
Feeding

CHAR
Always
Required

1

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1

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Column
ID
Y

Field Name

Field Type

Field Length

Description

Dementia

1

Z

Pyschoactive
Medications

CHAR
Always
Required
CHAR
Always
Required

AA

Restraints

CHAR
Always
Required

150

AB

Assistance with
Administering
Medications

CHAR
Always
Required

1

AC

Pain Management

CHAR
Always
Required

1

AD

Skilled Therapy

CHAR
Always
Required

1

AE

Currently Receiving
Skilled Therapy

1

AF

Functional Decline

AG

Oxygen Use

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

AH

Dialysis

1

AI

Impaired Vision

CHAR
Always
Required
CHAR
Always
Required

AJ

Impaired Hearing

CHAR
Always
Required

1

Yes (Y) / No (N) indicator on whether
the participant has/had a diagnosis of
dementia?
Yes (Y) / No (N) indicator on whether
the participant received psychoactive
medications during the audit review
period?
If physical or chemical restraints were
used on the participant at any time
during the audit review period, please
describe what restraint was used.
Yes (Y) / No (N) indicator on whether
the participant requires/required
assistance with administering
medication?
Yes (Y) / No (N) indicator on whether
the participant was prescribed pain
management during the audit review
period?
Yes (Y) / No (N) indicator on whether
the participant has ever received skilled
therapy during the audit review period.
Include all types of skilled therapy
received.
Yes (Y) / No (N) indicator on whether
the participant is currently receiving
skilled therapy?
Yes (Y) / No (N) indicator on whether
the participant experienced a functional
decline during the audit review period?
Yes (Y) / No (N) indicator on whether
the participant regularly used oxygen (as
indicated by the care plan) during the
audit review period (not as a result of an
acute event)?
Yes (Y) / No (N) indicator on whether
the participant received dialysis during
the audit review period?
Yes (Y) / No (N) indicator on whether
the participant has impaired vision (i.e,
blind or vision is severely impaired
without corrective lenses)?
Yes (Y) / No (N) indicator on whether
the participant has impaired hearing (i.e.,
deaf or hearing is severely impaired
without an assistive hearing device)?

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1

1

1

1

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Table 6: Quality Assessment Initiatives Records (QAIR) Record Layout
• Include each quality initiative that occurred during the audit review period and the
corresponding data used in the quality initiative. Data could include examples such as
hospitalizations, falls, grievances, appeals, medical records, audits, etc.
Column
ID
A

Field Name

Field Type

Data Identifier

B

Quality Initiative Name

C

Quality Initiative Goal

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

D

QAPI Plan

E

Incident

F

Type of Data Collected

G

Start Date of Quality
Initiative

H

End Date of Quality
Initiative

I

Root cause

J

Corrective Action
Required

K

Corrective Action
Implemented

L

M

Field
Length
3

Description

100

Provide a name for the quality initiative (e.g.,
falls reduction).

500

Provide a description of the quality initiative
goal (e.g., The purpose of this quality
initiative is to reduce falls in participants
identified as a high risk for falls).
Yes (Y) / No (N) indicator on whether this
initiative was conducted as a result of its
inclusion in the approved QAPI plan?
Yes (Y) / No (N) indicator on whether this
initiative was conducted as a result of an
incident that occurred during the audit review
period?
Enter the type of data that was used as a part
of the quality initiative (e.g. grievances,
appeals, assessments, etc.).
Provide the date the quality initiative began.
Submit in format CCYY/MM/DD (e.g.
2017/02/01).
Provide the date the quality initiative was
concluded. Submit in format CCYY/MM/DD
(e.g. 2017/02/01). Enter NA if the quality
initiative has not concluded (it is ongoing).
Yes (Y) / No (N) indicator of whether any
root cause analyses were done as a result of
the quality initiative?
Yes (Y) / No (N) indicator on whether the PO
determined that any corrective actions were
required as a result of the quality initiative?
Yes (Y) / No (N) indicator on whether the PO
implemented any corrective actions as a result
of the quality initiative? Enter NA if no
corrective action was necessary.
Provide the date the PO began implementing
corrective action as a result of the quality
initiative. Submit in format CCYY/MM/DD
(e.g., 2017/02/01). Enter NA if no corrective
action was necessary.
Yes (Y) / No (N) indicator on whether the PO
identified any potential participant harm
relating to this issue?

CHAR
Always
Required
CHAR
Always
Required

1

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

200

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

1

Start Date of Corrective
Action Implementation

CHAR
Always
Required

10

Potential Participant
Harm

CHAR
Always
Required

1

Page 27 of 29

1

10

10

1

2

Enter a unique identifier (number) for each
row of data. Use numbers 1, 2, 3, 4, etc.

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Column
ID
N

Field Name

Field Type

Actual Participant
Harm

O

Quality Improvements

CHAR
Always
Required
CHAR
Always
Required

P

Quality Improvements
Description

CHAR
Always
Required

1000

Q

Ongoing Review or
monitoring

1

R

Frequency of review/
monitoring

CHAR
Always
Required
CHAR
Always
Required

Page 28 of 29

Field
Length
1

1

10

Description
Yes (Y) / No (N) indicator on whether the PO
identified any actual participant harm (such as
an injury)?
Yes (Y) / No (N) indicator on whether any
quality improvements were initiated as a result
of this quality initiative (e.g., policies and
procedures updated, staff retrained,
programmatic change, etc.).
If applicable, describe the quality
improvements initiated as a result of this
quality initiative. If no quality improvements
were initiated enter NA.
Yes (Y) / No (N) indicator on whether there
was ongoing review or monitoring of this
quality initiative?
Provide the frequency of the ongoing review
or monitoring that was conducted (or is being
conducted). Daily, weekly, monthly, random.
Enter NA if no ongoing review or monitoring
is done.

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Programs of All-Inclusive Care for the Elderly (PACE)
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Table 7: On-Call Universe (OCU) Record Layout
• Include all after hour calls received by the PO.
• Exclude all calls received during normal business hours.
Column
ID
A

Field Name

Field Type

Field Length

Description

Participant First Name

50

First name of the participant.

B

Participant Last Name

50

Last name of the participant.

C

Participant ID

25

The identification number the PO uses
to identify the participant.

D

Caller Information

50

E

Date of Call

F

Time of Call

Provide who made the call (e.g.
participant, daughter, spouse, caregiver,
etc.).
Provide the date the call was received.
Submit in CCYY/MM/DD format (e.g.
2017/01/01).
Provide the time the call was received.
Submit in HH:MM format (e.g. 23:54).

G

Call Description/
Reason For Call

H

Response to Call

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

10

5

1500

Provide a description of the call (e.g.
reason for the call).

1500

Provide a description of the response to
the call as it relates to the participant
(e.g. did the PO send someone to the
participant’s home, did the participant
go to the hospital, etc.).

PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
The valid OMB control number for this information collection is 0938-TBD. The time required to complete this information collection is estimated to average 240 hours
per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you
have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA
Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

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