PACE Quality Data With RCA

PACE Quality Data Monitoring & Reporting
Guidance
2020

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),
§§460.140, 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 by the 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 (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 is related to administrative processes, such as appeals, grievances, enrollments,
disenrollments, enrollment denials, etc., and does not require a root cause analysis (RCA) 1. 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 is related 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 within three working days of
identifying the incident.

Page 2

PO must also initiate the RCA investigations internally within three working days of identifying the incident.
The analysis must be completed and documented in HPMS within 45 days of identifying the incident. 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 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 45 days of identifying the incident, POs should
inform their CMS AM. Also, if completion of the RCA extends beyond the respective quarter, POs will need to
request an extension in HPMS. Please see the HPMS PACE Quality Monitoring User Guide for additional
information and instructions on requesting an extension.
PACE Quality Data
PACE Quality Data Without
RCA
PACE Quality Data With
RCA
RCA Investigation

Reporting Frequency in
HPMS
Quarterly, with a 45 calendar
day reporting grace period at
the end of each quarter
Within 3 working days of
identifying the incident
Within 45 days of identifying
the incident

Other Considerations
POs are not precluded from
reporting data prior to the end
of the quarter.
POs are not precluded from
reporting data sooner than 3
days.
PO must initiate RCA
investigations internally
within 3 working days of
identifying the incident and
conclude the investigation
within 45 days.

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 root cause analysis (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:
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)

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)
Page 3

l) Compliance with PO’s established policies and procedures
m) Identification of risk points or policy deficiencies and their potential contribution to the event
n) 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:
•
•
•
•
•
•
•

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 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/Psychological
Abuse, Financial or
Material Exploitation,
Neglect, Physical Abuse,
Self-Neglect and Sexual
Abuse.

All abuse incidents confirmed by state Yes
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.

Appeals are entered into HPMS once the No
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/MedWatch/H
owToReport/default.htm.

Page 5

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

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

•
•

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

•

•
•

Root Cause Analysis
Required?
Yes/No

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.
Burn(s) 2nd degree or higher; and/or
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.

Yes

All elopements.

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

Reporting Thresholds
•
•
•
•
•

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.

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

•
•

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

Root Cause Analysis
Required?
Yes/No

No
Data is collected at an organizational
level until the last day of the quarter and
includes:
Disenrollment’s
New Enrollments,
Total Deaths, and
Enrollment Denials (prospective
enrollees) including the denial date and
denial reason.
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/MedWatch/H
owToReport/default.htm.
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.

Yes

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

No

Page 7

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

Root Cause Analysis
Required?
Yes/No

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 Centers for Disease
Control and Prevention (CDC).

Grievances: A
•
grievance is defined as a
complaint, either written •
or oral, expressing
•
dissatisfaction with
service delivery or
quality of care.

Grievances are entered under one of two No
categories:
Resolved; or
Alternative Solution, which means that
the PO has chosen an alternative option
to address the grievance(s) safely and
appropriately.
Please 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 the
No
following information regarding
vaccinations:
• The total number of participants enrolled
during the reporting period (including all
disenrolled and deceased participants);
• The total eligible to receive
immunization;
• The number of vaccines administered by
the PO to eligible participants;
Pneumococcal:
• The total number eligible participants
https://www.cdc.gov/vac
who did not receive the
cines/vpd/pneumo/index.
Pneumococcal/Influenza for the
html
following reasons:
o Medically contraindicated;
Influenza:
http://www.cdc.gov/vacci
o Prior immunization;
nes/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.

Yes
Resulted in death; or
All incidents that are reportable to the
respective State or County public health
authority, have three or more cases and
are linked to the same infectious agent
within the same time frame. Some
situations may require additional
reporting to the CDC.

Page 9

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, webbased, radio, etc.) that
may potentially or
actually presents a
harmful characterization
of a PO or the National
PACE program.

Yes
Any report of which the PO is aware
through local, state, regional, or national
media outlets (print, television or radio
broadcast, web- based, 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.

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.

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.

Page 10

PACE Quality Monitoring & Reporting Guidance

Incident

Reporting Thresholds

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.

•
•
•

Root Cause Analysis
Required?
Yes/No

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

Yes

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

Suicide attempt; or
Resulted in death

Yes

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
Unexpected death with a coroner
investigation.

Yes

Page 11

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 12

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, as well as
prospective enrollee denials, during the reporting quarter.
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.
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
Page 13

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.
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.

Page 14

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 drug that is used for discipline or convenience and is not required to treat
medical symptoms.

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 15

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

http://www.cdc.gov

Centers for Medicare & Medicaid Services
• Quality initiatives and research

http://www.cms.gov

PACE Regulations (42 CFR 460)

http://www.ecfr.gov

Food and Drug Administration
• Drug safety
• Medical device and equipment safety
• MedWatch reporting

http://www.fda.gov

ICD 10 CODES
The Joint Commission
National Academies of Sciences, Engineering
and Medicine (formerly the IOM)
• Aging issues
• Healthcare 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
American Society of Consultant Pharmacists

https://www.cms.gov/Medicare/Coding/ICD10/index
www.jointcommission.org
https://www.nap.edu/

https://npiap.com

http://www.nia.nih.gov

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

Page 16

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 June 30, 2020. The time required to complete this information collection is
estimated to average 1-2 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 17