PACE Quality Data Without RCA

PACE Quality Data Monitoring & Reporting
Guidance
March 2021

Page 1

This document provides an overview of the Programs of All Inclusive Care for the Elderly (PACE) quality
monitoring and reporting requirements outlined in Title 42 of The Code of Federal Regulations (CFR),
§§460.130(d), 460.200(b)(1), 460.200(c) and 460.202. Note that POs are also required to timely report certain
unusual incidents to other Federal and State agencies consistent with applicable statutory or regulatory
requirements (see 42 CFR §460.136(a)(5)). Specific reporting requirements and timeframes may be found on
the respective Federal or State agency websites.
For example:
•
•

•

If a PO suspects an incident of elder abuse, it must notify the appropriate State agency with
oversight for elder affairs.
POs experiencing an incident related to equipment failure or administration of medication to a
participant that results in a serious adverse participant outcome are strongly encouraged to report
the incident to the FDA (through MedWatch on the FDA website).
POs experiencing an infectious disease outbreak (three or more participants affected bythe same
agent in the same time period) must report the outbreak to the State public health agency and
concurrently to the Centers for Disease Control and Prevention (CDC), if required.

To be in compliance with the above-referenced regulatory requirements, PACE organizations (POs) must report
both aggregate and individual PACE Quality Data to CMS. All PACE Quality Data must be reported in the
PACE Quality Monitoring Module in the Health Plan Management System (HPMS). For information on how to
enter PACE Quality Data, please see the HPMS PACE Quality Monitoring User Guide located in the PACE
Quality Module in HPMS. For questions regarding HPMS, contact the HPMS helpdesk at [email protected].
For questions regarding HPMS access, contact the HPMS user access mailbox at [email protected].
PACE Quality Data
There are two types of PACE Quality Data:
PACE Quality Data without Root Cause Analysis
This type of quality data relates to administrative processes, such as appeals, grievances, enrollments,
disenrollments, enrollment denials, etc., and does not require a root cause analysis (RCA). Other areas reported
under this category include utilization of services, for example, emergency care, hospital admissions, and
preventive care, e.g., immunizations. The frequency for reporting PACE Quality Data without RCA is
quarterly. CMS provides POs with a 45 calendar day reporting grace period at the end of each quarter. For
example, for quarter 1 which ends on March 31st, all PACE Quality Data must be reported by the deadline of
May 15th. POs are not precluded from submitting PACE Quality Data prior to the end of the quarter.
PACE Quality Data with Root Cause Analysis
This type of quality data relates to unusual incidents that result in serious adverse outcomes, or negative
national or regional notoriety related to PACE, and requires an RCA for quality improvement purposes and to
mitigate further and/or future incidence. Reportable incidents include, but are not limited to, unexpected deaths,
infectious disease outbreaks, falls with injury and/or serious traumatic injuries while enrolled in the PACE
program. The frequency for reporting PACE Quality Data with RCA is quarterly. CMS provides POs with a 45
calendar day reporting grace period at the end of each quarter. For example, for quarter 1 which ends on March
31st, all PACE Quality Data must be reported by the deadline of May 15th. POs are not precluded from
submitting PACE Quality Data prior to the end of the quarter.
Page 2

POs must also initiate an RCA investigation internally within three working days of identifying the incident.
The analysis must be completed and documented in HPMS within the 45 day grace period at the end of each
quarter. POs are required to document all RCA information in the fields provided in HPMS, as well as indicate
what the participant’s current status is, both prior to and at the conclusion of the RCA investigation.
For PACE quality incidents that require an RCA, CMS will consider the data submission complete once the
RCA data has been entered in HPMS. If an RCA cannot be completed and entered into HPMS within the 45
day grace period, the PO may request an extension in HPMS. Please see the HPMS PACE Quality Monitoring
User Guide for additional information and instructions on requesting an extension.
Note: Supporting documentation for an RCA may be submitted in HPMS through the upload document feature,
however, CMS does not require the submission of supporting documentation into HPMS and expects that this
will only be done on a voluntary basis, and only in extraordinary or unusual circumstances. Some examples of
supporting documentation may include, but are not limited to: police and/or coroner reports, complex adverse
outcomes, motor vehicle accidents involving serious injury and/or death, etc.
CMS expects POs to discuss PACE Quality Data and any RCA findings with their CMS Account Manager
(AM) on an ongoing basis. The AM may request a more detailed discussion with the PO regarding a specific
PACE quality incident/event, and the RCA that was conducted in response. To facilitate the discussion, the PO
should prepare a case presentation that includes the following information:
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Enrollment date
Participant’s current status
Significant diagnoses
Summary of the care history
Summary of the event
Immediate actions taken
IDT team’s main concerns related to participant prior to event
Precipitating/contributing factors
Participant’s involvement/actions surrounding the event
Participant’s degree of involvement in PACE program
Working relationship with contracted facility, contracted services (if applicable)
Compliance with PO’s established policies and procedures
Identification of risk points or policy deficiencies and their potential contribution to the
event
Actions taken by the PO to reduce future risk, i.e., quality improvement projects, policy
revision, staff training, participant education, revision of procedures, alteration in staffing
levels, etc.

It is important that POs document all participant related events, such as falls, burns, adverse outcomes, etc. in
the medical record, including those that result in injury, require treatment, a change in the care plan, or loss of
function. Documentation should include details of the incident as well as assessments, diagnoses, consultations,
changes to the plan of care, follow-up, and progress notes, as appropriate/required. The PO does not need to
include details in the medical record that relate to the investigation of the incident/event (e.g., contributing
factors, inconsistent care that conflicted with policy, quality concerns, etc.). Instead, this documentation should
be kept separately in a Quality Assurance file.
POs should regularly monitor their PACE Quality Data for Quality Improvement (QI) purposes using a
standardized methodology (e.g., Plan, Do, Study, Act, known as PDSA) to:
Page 3

•
•
•
•
•
•
•

Identify, track and trend opportunities and/or areas in need of improvement;
Develop and implement a plan(s) of action to improve or maintain quality of care and services;
Institute QI-driven change in policies, procedures, systems, or training as appropriate;
Evaluate the effectiveness of interventions;
Monitor for sustained improvement;
Report and discuss findings with oversight committees including the PO’s governing body; and
Document evidence of a performance improvement activity(s) for review by the PACE
organization, CMS, and the State Administering Agency (SAA).

PACE Quality Data Reporting Requirements and Thresholds
Appendix A provides the PACE Quality Data reporting requirements and thresholds. For additional
information, please see Appendix B, Defining Terms. For questions concerning PACE Quality Data
reporting, POs should contact their CMS AM and/or the PACE portal at https://pace.lmi.org.

Page 4

PACE Quality Monitoring & Reporting Guidance

Appendix A: PACE Quality Data Reporting Requirements and Thresholds
Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

Abuse: Categories of •
abuse include:
Abandonment,
Emotional/Psychologi •
cal Abuse, Financial
or Material
Exploitation, Neglect,
Physical Abuse, SelfNeglect and Sexual
Abuse.

All abuse incidents confirmed by
state authorities are reported to
CMS.
Please note, all suspected and
allegations of abuse must be
reported to appropriate state
authorities, but only reported to
CMS as a quality incident if the
abuse is confirmed.

Appeal: An appeal is •
a participant's or
caregiver’s action
taken with respect to
the PO’s non-coverage
of, or nonpayment for
a service, including
denials, reductions, or
termination of
services.

No
Appeals are entered into HPMS
once the appeal has been resolved or
denied.

Adverse Drug
•
Reaction: Any
•
unintended effect on
the body as a result of
the use of therapeutic
drugs, drugs of abuse,
or the interaction of
two or more
pharmacologically
active agents.

Yes
Resulted in death; or
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to the adverse
drug reaction; or any adverse drug
reaction that meets the Food and
Drug Administration (FDA)
guidelines for reporting under the
FDA’s MedWatch program. More
information regarding reporting and
the definition of a serious adverse
drug reaction can be found on the
FDA’s website at:
http://www.fda.gov/Safety/MedWat
ch/HowToReport/default.htm.

Page 5

Yes

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

Adverse Outcome: A •
serious, undesirable, •
and unexpected
outcome resulting
from the participant’s
care or treatment.

Yes
Resulted in death;
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to the adverse
outcome; or resulted in a fracture
requiring surgical interventions.

Burns 2nd Degree or •
Higher: An injury to •
tissue caused by heat,
friction, electricity,
radiation, or chemicals
that results in a 2nd or
3rd degree burn(s).

Burn(s) 2nd degree or higher; and/or Yes
Required the following:
o Treatment by a physician or
primary care provider,
and/or
o An emergency room visit, or
required hospitalization
(admission or observation
stay more than 23 hours)
related directly to the burn.

Elopement: A
•
participant with
cognitive impairment,
wanders away or
leaves an area without
supervision or
authorization and
presents a safety threat
to the participant
and/or others.

All elopements.

Emergency Room
and/or Urgent Care
Visit(s): Is any
unscheduled care
provided in an
emergency room or
urgent care center.

•

•

•

Yes

No
Any instance in which a PACE
participant receives unscheduled
care provided in a hospital
emergency room or an urgent care
center.
Data includes whether or not the
participant was admitted to the
hospital (yes/no) or observation
stay, and
Has this participant had repeat ER
visits (i.e. a return visit to an ER or
urgent care setting within the
reporting period)?
Page 6

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

Enrollment Data:
•
Enrollment data is the
total number of
participants who were •
enrolled in the PACE •
organization, as well •
as prospective enrollee
denials, during the
reporting quarter.
•

No
Data is collected at an
organizational level until the last
day of the quarter and includes:
Total Enrollments;
Total New Enrollments;
Enrollment Denials (prospective
enrollees) including the denial date
and denial reason;
Total Disenrollments (does not
include deaths); and
• Total Deaths.
Note: Participant deaths should be
reported as a “death” and not as a
“disenrollment” from PACE.

Equipment Related •
Occurrences: Failure •
of medical equipment
or device to perform in
accordance with
manufacturers’
specifications, or
failure to operate
equipment as intended
by the manufacturer.

Yes
Resulted in death;
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to the
equipment-related occurrence; or
An equipment related occurrence
that directly affected the
participants’ safety that meets the
FDA guideline for reporting under
the FDA’s MedWatch program.
More information regarding
reporting can be found on the
FDA’s website:
http://www.fda.gov/Safety/MedWat
ch/HowToReport/default.htm.

Falls with Injury: A •
sudden, unintentional, •
descent of the body to
either the
floor/ground, or
another object.

Resulted in death;
Resulted in a fracture; or
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to the fall.

Page 7

Yes

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

Falls without Injury: •
A sudden,
unintentional, descent
of the body to the
floor/ground, or
another object.

Any fall that does not result in
death, a fracture, or an injury
requiring hospitalization related
directly to the fall.

Fires/Other
•
Disasters:
•
Environmental event
at a PACE-sponsored
setting that requires
the evacuation of, or,
an unanticipated
•
closure of a PACE
center.

Yes
Resulted in death;
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to the fire or
disaster; or
Resulted in the inability to provide
care/disruption of care.

Foodborne
•
Outbreak: A
•
foodborne disease
outbreak is defined as
an incident in which
three or more persons
experience a similar
illness resulting from
the ingestion of a
common food.

Yes
Resulted in death; or
All foodborne outbreaks that meet
the threshold of three or more cases
of persons exhibiting related
symptoms resulting from intake of a
similar food source must be reported
to CMS and the State public health
authority. Some situations may
require additional reporting to the
CDC.

No

Grievances: A
• Grievances are entered under one of No
grievance is defined as
two categories:
a complaint, either
• Resolved; or
written or oral,
• Alternative Solution, which means
expressing
that the PO has chosen an
dissatisfaction with
alternative option to address the
service delivery or
grievance(s) safely and
quality of care.
appropriately.
Note: Some grievances may not be
resolved to the participants/caregiver
satisfaction, however, CMS expects that
all grievances will reach a resolution.

Page 8

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

For each participant, the PO provides
No
the following information regarding
vaccinations:
• All participants enrolled during the
reporting period (including new,
current, disenrolled and deceased
participants);
• The total eligible to receive
immunization;
• The number of vaccines
administered by the PO to eligible
participants;
Pneumococcal:
https://www.cdc.gov/v • The total number eligible
participants who did not receive the
accines/vpd/pneumo/in
Pneumococcal/Influenza for the
dex.html
following reasons:
Influenza:
o Medically contraindicated;
http://www.cdc.gov/va
o Prior immunization;
ccines/vpdo Refused;
vac/flu/default.htm.
o Vaccine unavailable; or
o Missed opportunity (vaccine
available but was not
administered); and
• The number of participants who
received the vaccine and reported or
had a reaction.
Immunizations:
Pneumococcal and
influenza
immunizations are
reported for all
participants enrolled
during the reporting
period. CMS expect
POs to immunize
participants according
to current CDC
guidelines.

Infectious Disease
•
Outbreak: Three or •
more cases of the
same illness resulting
from the same source •
or infectious agent
impacting PACE
participants.

Resulted in death; or
All incidents that are reportable to
the respective State or County
public health authority; or
Have three or more cases and are
linked to the same infectious agent
within the same time frame. The
time frame is dependent on the
infectious agent.
Note: Some situations may require
additional reporting to the CDC.

Page 9

Yes

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

Media Related
•
Event: Any reporting
through local, state,
regional or national
media outlets (print,
broadcast, web-based,
radio, etc.) that may
potentially or actually
presents a harmful
characterization of a
PO or the National
PACE program.

Any report of which the PO is aware Yes
through local, state, regional, or
national media outlets (print,
television or radio broadcast, webbased, etc.) that presents a potential
or actual harmful characterization of
a PO or the national PACE program
(e.g., a local newspaper article on an
investigation of reported elder abuse
by a PACE staff).

Medication
•
Administration
Errors Without an
Adverse Effect:
Medication errors that
occur in violation of a
physician’s order that
did not result in death,
injury or adverse
outcome requiring
hospitalization
(admission or
observation stay more
than 23 hours) related
directly to the
medication related
occurrence.

No
Any medication error including:
o Prescribing the wrong
medication to a participant;
o Dispensing the wrong
medication to a participant;
o Administration of the wrong
medication to a participant;
o Administration of medication via
an incorrect route;
o Administration of medication at
the incorrect time; or
o Administration of an incorrect
dosage of medication.

Page 10

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Medication Related •
Occurrence:
Medication errors that
occur in violation of a
physician’s order that
did result in death,
injury or adverse
outcome requiring
hospitalization
(admission or
observation stay more
than 23 hours) related
directly to the
medication related
occurrence.

Root Cause
Analysis Required?
Yes/No

Yes
Any medication error including:
o Prescribing the wrong
medication to a participant;
o Dispensing the wrong
medication to a participant;
o Administration of the wrong
medication to a participant;
o Administration of medication via
an incorrect route;
o Administration of medication at
the incorrect time; or
o Administration of an incorrect
dosage of medication.

Motor Vehicle
Accident: When a
PACE participant is
involved in an
accident while in a
vehicle that is
operated by PACE
Staff and or PACE
contractors.

•
•

Pressure Injury: A
pressure injury that is
acquired while
enrolled in PACE.

Yes
• Stage 3;
• Stage 4; or
• Unstageable
For more information, visit the National
Pressure Injury Advisory Panel website
at https://npiap.com.

•

Restraint Use: The
•
use of a physical or
chemical restraint on a
PACE participant.

Resulted in death;
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to motor
vehicle accident; or
Resulted in injury requiring
emergency room intervention
without hospitalization (i.e.
evaluation, suturing, splinting, or
other treatment).

Resulted in death; or
Resulted in injury requiring
hospitalization (admission or
observation stay more than 23
hours) related directly to restraint
use.

Page 11

Yes

Yes

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause
Analysis Required?
Yes/No

Suicide Attempt/
•
Suicide:
•
An individual
deliberately initiates a
behavior that will
cause self-harm.

Suicide attempt; or
Resulted in death.

Unexpected Death: •
Irreversible cessation •
of circulatory and
respiratory functions,
or irreversible
cessation of all
functions of the entire
brain that was
unanticipated and/or
unexpected in nature.

Homicide (known or suspected); or Yes
Unexpected death with a coroner
investigation.

Page 12

Yes

Appendix B: Defining Terms
Abuse: According to the National Center on Elder Abuse (NCEA), the following types of abuse are commonly
accepted as the major categories of elder mistreatment:
• Physical Abuse: Inflicting or threatening to inflict, the use of physical force that may result in bodily injury,
physical pain or impairment;
• Emotional or Psychological Abuse: The infliction of anguish, pain, or distress through verbal or nonverbal
acts;
• Sexual Abuse: Non-consensual sexual contact of any kind with an elderly person;
• Financial or Material Exploitation: The illegal or improper use of an elder’s funds, property, or assets;
• Neglect: The refusal or failure to fulfill any part of a person’s obligations or duties to an elder;
• Abandonment: The desertion of an elderly by an individual who has assumed responsibility for providing
care for an elder, or by a person with physical custody of an elder;
• Self-Neglect: Characterized as the behavior of an elderly person that threatens his/her own health or safety.
For more information on elder abuse, visit the NCEA website at https://ncea.acl.gov/.
Adverse Drug Reaction: Any unintended effect on the body as a result of the use of therapeutic drugs, drugs of
abuse, or the interaction of two or more pharmacologically active agents. A serious adverse drug reaction is one
that results in death, a life-threatening event, hospitalization, disability, or requires intervention to prevent
permanent impairment or damage. The FDA maintains a drug safety database containing reports of serious
adverse drug reactions entitled MedWatch. A serious adverse drug reaction will be reported when the patient
outcome meets FDA guideline for reporting a serious adverse event under the FDA’s MedWatch program.
More information regarding MedWatch reporting can be found on the FDA’s website at:
http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. CMS advises POs to monitor the FDA
MedWatch in order to keep up to date with important medical product information, including information on
prescription and over-the- counter drugs, biologics, medical devices, and special nutritional products.
Adverse Participant Outcome: A serious, undesirable, and unexpected outcome resulting from care or
treatment.
Appeal: An appeal is a participant's action taken with respect to the PO’s non-coverage of, or nonpayment for,
a service including denials, reductions, or termination of services.
Burn: An injury to tissue by heat, friction, electricity, radiation, or chemicals. Burns are characterized by
degree, based on the severity of the tissue damage. A first-degree burn causes redness and swelling in the
outermost layers of skin (epidermis). A second-degree burn involves redness, swelling and blistering, and the
damage may extend beneath the epidermis to deeper layers of skin (dermis). A third-degree burn, also called a
full-thickness burn, destroys the entire depth of skin causing significant scarring. Damage also may extend to
the underlying fat, muscle, or bone. The severity of the burn is also judged by the amount of body surface area
(BSA) involved.
Death: An irreversible cessation of circulatory and respiratory functions, or irreversible cessation of all
functions of the entire brain, including the brain stem. This determination is made in accordance with State and
Federal law. For reporting purposes, there are two categories of deaths, these include; 1. Deaths that are
expected or anticipated, and reported as part of enrollment data, and 2. Unexpected Deaths, which are a result
Page 13

of a homicide and/or otherwise unanticipated in nature and have or will undergo an active coroner investigation.
Elopement: Occurs when a participant with cognitive impairment, wanders away or leaves an area without
supervision or authorization and presents a safety threat to the participant and/or others.
CMS acknowledges the right of a PACE participant to leave the PACE center at will when mentally capable of
doing so. Therefore, for reporting purposes, the term elopement is limited to participants whose medical
condition(s) involves cognitive deficits and/or impaired judgment, or to those deemed legally incapable of
making their own decisions about complying with documented treatment plans.
Emergency Room Visit: Any instance in which a PACE participant receives unscheduled care provided in a
hospital emergency room or an urgent care center.
Enrollment Data: The total number of participants who were enrolled in the PACE organization during the
reporting quarter, including new enrollments and prospective enrollee denials, total disenrollments, and total
deaths. For purposes of PACE Quality Data reporting, a participant death should be reported as a “death” and
not as a “disenrollment” from PACE.
Equipment or Device Related Occurrence: The failure of medical equipment or device to perform in
accordance with manufacture’s specifications or failure to operate equipment as intended by the manufacturer.
Common causes of medical equipment or device failure include: lack of knowledge regarding the appropriate
operation of equipment or device, instructions, labeling, packaging errors, equipment or devices defects,
software defects, inappropriate interactions with other devices while in use, failure to conduct equipment or
device safety checks, failure to service equipment or devices as instructed by manufacturer, failure to report and
remove defective equipment or devices from patient care areas to ensure they are not used until they are
replaced or repaired that results in serious injury, serious illness, or death.
Fall: A sudden, unintentional, descent of the body to either the floor/ground, or another object, For reporting
purposes, there are two categories of falls, these include; 1. Falls without Injury, and 2. Falls with Injury that
result in death, fracture, and/or an injury requiring hospitalization (admission or observation stay more than 23
hours) related directly to the fall.
Fire/Other Disasters: An environmental event at a PACE-sponsored setting that requires the evacuation of, or,
an unanticipated closure of a PACE center, and usually results in the inability to provide care or causes a
disruption in care. These events include but are not limited to: Blizzard, Earthquake, Fire, Heavy Rain/Flood,
Hurricane, Ice Storm, Power Outage, Tornado and/or Other Type.
Foodborne Outbreak: A foodborne disease outbreak is defined as an incident in which three or more persons
experience a similar illness resulting from the ingestion of a common food.
Immunizations: Refers to the reporting of pneumococcal and influenza immunization data. Immunization data
is reported for all participants enrolled during the reporting period. Pneumococcal immunizations are reported
on a quarterly basis. The data collection period for influenza immunizations begins October 1 and ends March
31st of the following calendar year, and reported at the end of quarter 1.
Infectious Disease Outbreak: Three or more cases of the same illness resulting from the same source or
infectious agent impacting PACE participants. POs are required to report an infectious disease outbreak if one
or more of the criteria below is met:
Page 14

•
•
•

Resulted in death; or
All incidents that are reportable to the respective State or County public health authority; or
Have three or more cases and are linked to the same infectious agent within the same time frame. The
time frame is dependent on the infectious agent.

Media Related Incident: Any reporting through local, state, regional or national media outlets (print,
broadcast, web-based, radio, etc.) that may potentially or actually presents a harmful characterization of a PO or
the National PACE program. The PO must notify CMS and the SAA when knowledge of adverse publicity
could reflect poorly on either the local and/or national program. CMS and the respective SAA have the
obligation to maintain public trust and accountability to funding authorities. Timely notification by the PO
enables CMS and SAA to collaborate in transmitting an accurate perspective of the PACE program.
Medication Related Occurrences: Medication errors that occur in violation of a physician’s order and result in
death, injury or adverse outcome requiring hospitalization (admission or observation stay more than 23 hours)
related directly to the medication related occurrence.
POs must develop their pharmacy programs to prescribe, dispense, store, and administer the right medication to
the right participant in the right dose, at the right time, and via the right route. The identification of medicationrelated system failures is an essential PACE internal quality assurance responsibility. Common causes of
medication-related occurrences include confusion in the labeling of products, difficulty reading a prescriber's
handwriting, misunderstanding a verbal medication order, patient misunderstanding, and ambiguities in product
names or directions for use.
Medication Administration Errors without an Adverse Effect: Medication errors that occur in violation of a
physician’s order that do not result in death, injury or adverse outcome requiring hospitalization (admission or
observation stay more than 23 hours) related directly to the medication related occurrence.
Motor Vehicle Accident (MVA): Applies when a PACE participant is involved in an accident while in a
vehicle that is operated by PACE Staff and/or PACE contractors. POs must report a vehicle collision that occurs
while transporting PACE participants to and/or from a PACE sponsored activity. PACE sponsored activities can
include but are not limited to travel to and/or from the PACE Center, community-based appointments, visits,
excursions, etc.
Participant: Any individual enrolled in a PACE program.
Pressure Injury: According to the National Pressure Injury Advisory Panel (NPIAP), a pressure injury is
localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical
or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a
result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue
for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition
of the soft tissue.
PACE organizations must report stage 3, 4, and unstageable pressure injuries that develop while enrolled in
PACE. For more information on pressure injuries, please visit the NPIAP website at https://npiap.com/.
Quality Improvement Activities: Any activity undertaken by a PO to improve processes, the delivery of care
and services, or participant outcomes. Quality improvement activities may be targeted at the organizational,
provider team, or participant level.
Page 15

Examples include:
•
•
•

Assessment of home delivery process for medication, with goals of increased safety and efficiency;
The IDT develops a more comprehensive falls risk assessment and prevention protocol; or
Care plan modifications are made in response to an unusual event or near miss accident.

Reporting Quarter(s):
Quarters

Quarter Begins

Quarter Ends

1
2
3
4

January 1st
April 1st
July 1st
October 1st

March 31st
June 30th
September 30th
December 31st

Last Day to Enter Quarterly
Data
May 15th
August 15th
November 15th
February 15th

Restraint: PACE regulation 42CFR §460.114 stipulates that, if the interdisciplinary team (IDT) determines that
a restraint is needed to ensure the participant's physical safety or the safety of others, the organization must limit
the use of restraints to the least restrictive and most effective method available. Although CMS expects POs to
try alternative methods for achieving a safe environment or safe participant behavior, PACE regulations do
permit the limited use of these restraint types:
•

•

Physical restraint--any manual method or physical/mechanical device, material, or equipment attached
or adjacent to the participant’s body that cannot easily be removed and restricts freedom of movement or
normal access to one’s body. Examples include but are not limited to leg restraints, arm restraints, hand
mitts, soft ties, vests, lap cushions, and lap trays that can’t easily be removed.
Chemical restraint--any medication used to control behavior or to restrict the participant's freedom of
movement and is not a standard treatment for the participant's medical or psychiatric condition.

Root Cause Analysis: A multi-disciplinary process of study or analysis that uses a detailed and structured
process to examine factors contributing to a specific outcome (e.g., an adverse event).
Suicide Attempt: An act with a non-fatal outcome in which a participant deliberately initiates a behavior that,
without intervention from others, will cause self-harm, or deliberately ingests a substance in excess of the
prescribed or generally recognized therapeutic dosage that will cause self-harm.

Page 16

Appendix C: Resources
Resources

Webpage

Agency for Healthcare Research and Quality
• Clinical practice guidelines
• Preventing medical errors
• Quality care
• Safe care

http://www.ahrq.gov

Centers for Disease Control and Prevention
• Immunizations
• Infectious disease and foodborne
outbreaks
• Injury, violence and safety
• Older adults and seniors health issues
Centers for Medicare & Medicaid Services
• Quality initiatives and research
PACE Regulations (42 CFR Part 460)
Food and Drug Administration
• Drug safety
• Medical device and equipment safety
• MedWatch reporting
ICD 10 CODES

http://www.cdc.gov

http://www.cms.gov
http://www.ecfr.gov
http://www.fda.gov

https://www.cms.gov/Medicare/Coding/ICD10/index

The Joint Commission

www.jointcommission.org

National Academies of Sciences, Engineering
and Medicine (formerly the IOM)
• Aging issues
• Health care and quality issues
• Research publications
National Pressure Injury Advisory Panel
• Research and guidelines on pressure injury
management
National Institute of Aging
• Research publications
• Safety issues
Institute for Safe Medication
Practices
National Association of Boards of Pharmacy

https://www.nap.edu/

https://npiap.com

http://www.nia.nih.gov

http://www.ismp.org/
http://www.nabp.net/

American Society of Consultant Pharmacists

http://www.ascp.com/

Page 17

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 0938-1264
(CMS-10525). The current expiration date is December 31, 2023. The time required to complete this information collection
is estimated to average 1- 4 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.

Page 18