Level II Monitoring Data Entry

PACE Level II
Reporting Guidance
July 2015

PACE Level II Reporting Guidance
Table of Contents

Introduction

3

Level II Reporting Requirements

3

Level II Incidents and Reporting Thresholds

3

Table 1: Level II Incidents and Reporting Thresholds

4

Additional Reporting go Other Federal and State Health Authorities

7

Process for Level II Notification to CMS and SAA and Completion
of Internal Investigation

7

Format for Level II PACE Organization Conference Call Presentation 9
Appendix A – Definition of Terms for Level II Reporting

10

Appendix B –References

16

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PACE Level II Reporting Guidance
Introduction
This guidance provides PACE organizations (POs) with an overview of requirements to report both
aggregate and individual level data to the Centers for Medicare & Medicaid Services (CMS) and
State administering agencies (SAAs) for their use in monitoring POs’ performance.
Level II Reporting Requirements apply specifically to unusual incidents that result in serious
adverse participant outcomes, or negative media coverage related to the PACE program. POs are
required to report incidents within 3 working days to https://DMAO.LMI.org with a copy to the
Regional Office (RO) and the SAA. This guidance details Level II incidents and the required
reporting actions. CMS and SAAs partner with POs to enhance their internal quality assurance
and risk management activities. Through the reporting requirements, CMS and the SAA monitor
the PO’s quality of care and risk reduction efforts.
Level II Incidents and Reporting Thresholds
Table 1, Level II Incidents and Reporting Thresholds, identifies these incidents and related
reporting thresholds. Level II incidents require internal investigation and analysis of the
occurrence by the PO with the goal of identifying systems failures and improvement opportunities.
In addition, after a Level II incident occurs, the PO must immediately correct any identified
problem that directly or potentially threatens the health and safety of a PACE participant. See 42
CFR §460.136(a)(5). Please see pages 8-9 for information on conducting a Root Cause Analysis.

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PACE Level II Reporting Guidance
Level II Incidents and Reporting Thresholds
(See Appendix A for definitions of terms)

Incident

Level II Reporting Thresholds

Abuse: including self-inflicted and
physical, financial, verbal,
emotional, psychological, or sexual.

All suspected and allegations of abuse must be reported to
appropriate state authorities. All abuse incidents confirmed by state
authorities are reported to CMS as a Level II.

Adverse Drug Reactions: 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.

Resulted in death; or
Resulted in injury requiring hospitalization (admission or observation
stay more than 23 hours) related directly to 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/HowToReport/default.htm.
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.

Adverse Outcome: a serious,
undesirable, and unexpected
outcome resulting from the
participant’s care or treatment.
Burns: an injury to tissue caused
by heat, friction, electricity,
radiation, or chemicals.

Deaths: irreversible cessation of
circulatory and respiratory
functions, or irreversible

Burn(s) 2nd or 3rd degree;
All repeat burn(s) (3 or more in 90 days) burn incidents by the same
participant; or
Resulted in providing treatment greater than first aid or requiring
hospitalization (admission or observation stay more than 23 hours)
related directly to the burn.
Homicide (known or suspected); or
Unexpected Death (provide an active coroner investigation when
submitting Root Cause Analysis (RCA) to CMS).

cessation of all functions of the
entire brain.
Elopement: a participant wanders
away or leaves a PACE-sponsored
setting, participant’s home, Skilled
Nursing Facility, or Assisted Living
Facility without notification.
Equipment-Related Occurrences:
failure of medical equipment or
device to perform in accordance to
manufacturers’ specifications or
failure to operate equipment as
intended by the manufacturer.

All elopements.

Resulted in death;
Resulted in injury requiring hospitalization (admission or observation
stay more than 23 hours) related directly to 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/HowToReport/default.htm.
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PACE Level II Reporting Guidance
Level II Incidents and Reporting Thresholds
(See Appendix A for definitions of terms)

Incident
Falls: sudden, uncontrolled,
unintentional, non-purposeful
downward displacement of the body
to the floor/ground, or hitting
another object.
Fires/Other Disasters:
environmental event at a PACEsponsored setting that requires
evacuation or unanticipated or
sudden closure of a PO.
Food-borne outbreak: three or
more cases get the same
symptoms from the same
contaminated food or drink.

Infectious Disease Outbreak:
three or more cases of the same
illness resulting from the same
source or infectious agent impacting
participants in a PACE Center,
contracted facility, or other PACE
housing arrangements.

Media-related Event: any
reporting through local, state,
regional or national media outlets
(print, broadcast, web-based, radio,
etc.) that presents a potential or
actual harmful characterization of a
PO or program.
Medication-related Occurrences:
mistakes or errors that occur when
prescribing, dispensing, or
administering a medication.

Level II Reporting Thresholds
Resulted in death;
Resulted in a fracture; or
Resulted in injury requiring hospitalization related directly to the fall.

Resulted in death;
Resulted in injury requiring hospitalization (admission or observation
stay more than 23 hours) related directly to the fire or disaster;
Resulted in inability to provide care/disruption of care; or
Resulted in a loss of safe housing for PACE participants.
Resulted in death; or
All food-borne outbreaks that meet the threshold of three or more
cases of persons exhibiting related symptoms resulting from intake
of a similar food source may be reportable to the State public health
authority either prior to or after the completion of a RCA. Some
situations may require additional reporting to the Centers for Disease
Control and Prevention (CDC).
Resulted in death; or
All incidents of infectious disease outbreaks that meet the threshold
of three or more cases (or the respective State standard if more
stringent) linked to the same infectious agent within the same time
frame (incubation, sub-acute, and acute manifestation) and are
reportable to the respective State public health authority. Some
situations may require additional reporting to the CDC.
Note: It is possible that a participant residing in a contracted facility
could be affected by an outbreak there and may meet the reporting
threshold for another Level II reporting incident, such as unexpected
death. If so, POs report the threshold that is the primary cause of
death.
Any report of which the PO is aware through local, state, regional, or
national media outlets (print, television or radio broadcast, webbased, radio, 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).
Resulted in death;
Resulted in injury requiring hospitalization (admission or observation
stay more than 23 hours) related directly to the medication-related
occurrence; or
Resulted in a near-death event, e.g., anaphylaxis, cardiac arrest.

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PACE Level II Reporting Guidance
Level II Incidents and Reporting Thresholds
(See Appendix A for definitions of terms)

Incident
Motor Vehicle Accidents: When a
PACE participant is involved in an
accident involving a vehicle
operated by PACE Staff and or
PACE contracted/owned
transportation.
Pressure Ulcer: acquired while
enrolled in PACE.

Level II Reporting Thresholds
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 Department intervention
without hospitalization, such as evaluation, suturing, splinting, or
other treatment.
Stage III;
Stage IV; or
Unstageable.

Restraint Use: physical or
chemical.

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

Suicide and Suicide Attempts: an
individual deliberately initiates a
behavior that will cause self-harm.

Resulted in death; or
Suicide attempts.

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PACE Level II Reporting Guidance
Additional Reporting to Other Federal and State Health Authorities
In addition to required CMS and SAA reporting, POs are also required to report certain unusual
incidents to other Federal and State agencies consistent with these agencies’ requirements. 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. In some situations, the State agency may instruct the PO to report concurrently to
the CDC.

The PO must make the notification(s) and take any required actions within the prescribed
timeframe to comply with applicable statutory or regulatory requirements (see 42 CFR
§460.136(a)(5)). Specific requirements can be found on the respective Federal or State
agencies’ websites.
Process for Level II Notification to CMS and SAA and Completion of Internal Investigation
1) Notify CMS and the SAA. Notify CMS via https://DMAO.LMI.org and copy the RO AM and
SAA within three working days of incident occurrence.
Content of initial notification:
a) Issue: PACE Level II Report
b) Type of incident and date incident occurred
Location of incident
c) Participant’s current status
Significant diagnoses
d) Summary of the care history
Summary of the event
e) Reported to other Federal or State health authorities
f) Provide complete contact information (e.g., name, PO, phone number, and email)

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PACE Level II Reporting Guidance
Illustrative Example:
a) Issue: PACE Level II Report
b) Fall on March 13, 2014
c) Home
d) Critical
e) HTN, DM, Osteoporosis, ESRD, syncope
f) Participant has had 6 falls in the past 12 months
g) Participant was walking from bathroom to the bedroom without walker and fell in hallway.
Participant hit their head on the wall. Participant was unable to get up and pushed emergency
alert button for assistance. EMS arrived and transported participant to emergency department.
Participant is currently in the ICU with hip, rib, and ankle fractures and a subdural hematoma.
h) Department of Health and Mental Hygiene notified on May 6, 2014
i) James Jones
Quality Improvement Coordinator
PACE Orlando Florida
407-555-1234
Note: This example is for illustrative purposes only.
[email protected]
CMS may request that the PO conduct a full RCA. If CMS determines that a RCA is needed, CMS
will send a response to the PO to initiate an internal investigation. The email from CMS will include
a CMS reference number which must be included in all correspondence regarding the incident.
If the PO is unsure of whether a threshold for Level II reporting has been met, the PO should
consults with their CMS Account Manager first before submitting their question via
https://DMAO.LMI.org. The PO’s contact with CMS must be made by the next business day after
a determination that Level II reporting may be required.
All participant-specific events resulting in injury, requiring treatment, a change in the plan of care,
or loss of function must be documented in the medical record.
2) Conduct Root Cause Analysis. A PACE organization must initiate an investigation within three
working days of reporting the incident to CMS and the SAA. The analysis must be concluded
within 45 calendar days of reporting the incident. If the analysis cannot be completed within 45
calendar days, the PO must notify CMS via https://DMAO.LMI.org with a copy to the RO AM and
the SAA. The notification must describe the circumstances that prevented completion of the
investigation within the 45 calendar day time period and provide information on when the analysis
will be completed. CMS will then provide the PO with an extended timeframe to complete their
RCA.
As discussed above, it is important that a PACE organization document all participant-specific
events in the medical record, especially if they result in injury, require treatment, a change in the
care plan, or loss of function. Documentation should include a statement of the event, an
assessment, a diagnosis (if appropriate), policy changes, follow-up plans and participant progress.
However, any specific details that relate to the investigation of the event (e.g., what were the
contributing factors, was care inconsistent with policy, any concerns of quality, etc.) do not need to
be included in the medical record. All such documentation should be kept separately in a Quality
Assurance file.
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PACE Level II Reporting Guidance
3) Notify CMS via https://DMAO.LMI.org with a copy to the RO AM and the SAA of the
completed analysis. The RO AM may schedule a conference call to discuss the PO’s internal
investigation, subject to the availability of key individuals (CMS AM, CMS clinician, PO, and
SAA) from all entities.
Format for Level II PACE Organization (PO) Conference Call Case Presentation
When the PO has completed its RCA, the PO must notify CMS via https://DMAO.LMI.org with a
copy to the RO AM and the SAA. The PO must prepare a case presentation for discussion on the
call. When preparing the case presentation, the PO will include the following information in its
discussion:
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
m)
n)
o)
p)

Reference number
Age and gender
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
As appropriate, quality improvement projects, proposed improvements in policies, training,
procedures, systems, processes, physical plant, staffing levels, etc. to reduce future risks.

This non-identified information must be sent to https://DMAO.LMI.org as an unencrypted
attachment prior to the call.
Process for Conducting Root Cause Analysis
The PO must conduct a RCA, within three working days of reporting the incident, for events for
which the PO’s staff, or staff in consultation with CMS, determines the identified event is
sufficiently serious that an in-depth understanding of how it occurred is essential, or multiple failsafe measures are required as part of the PO’s quality assessment and performance improvement
(42 CFR §460.130, §460. 132, §460134 and §460.136).
Rescinding a Level II Incident
If at any time during the investigation, a Level II does not meet the Level II Reporting Thresholds
as listed in Table 1 Level II Incidents and Reporting Thresholds, the PO should notify CMS via
https://DMAO.LMI.org and a copy to the RO AM and SAA. The submission should include the
reference number and the reason for rescinding the Level II incident.

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PACE Level II Reporting Guidance
Appendix A: Definition of Terms for Level II Reporting
The following terms are operational definitions used to assist POs in determining which
should be reported as Level II incidents.
Abuse: The willful infliction of injury, unreasonable confinement, intimidation, or punishment with
resulting physical harm, pain, mental anguish, or death. This also includes the deprivation by an
individual, including a caretaker, of goods or services that are necessary to attain or maintain
physical, mental, and psychosocial well-being.
The National Center of Elder Abuse¹ defines three categories of elder abuse:
• Domestic Elder Abuse: generally refers to any of several forms of maltreatment of an
elderly adult person by someone who has a special relationship with the elder (a spouse, a
sibling, a child, a friend, or a caregiver), that occur in the elder’s home, or in the home of a
caregiver.
• Institutional abuse: generally refers to any of the above-mentioned forms of abuse that
occur in residential facilities for elderly persons (e.g., nursing homes, foster homes, group
homes, and care facilities). Perpetrators of institutional abuse usually are persons who
have a legal or contractual obligation to provide elder victims with care and protection
(e.g., paid caregivers, staff, and professionals).
• Self-Neglect or Self Abuse: is characterized as the behavior of an elderly person that
threatens his/her own health or safety. Self-neglect generally manifests itself in an older
person as a refusal or failure to provide himself/herself with adequate food, water, clothing,
shelter, personal hygiene, medication (when indicated- or gives away, sells their
medication and or replace their medication with illegal medications ), and safety
precautions.
Abuse may include the following:
Verbal Abuse: The use of oral, written, or gestured language that willfully includes
disparaging and derogatory terms to the elder person or their families, or within their hearing
distance, regardless of their age, ability to comprehend, or disability. Examples of Verbal
Abuse: Threats of harm, saying things to frighten an elderly person, (e.g. such as telling a
elder he/she will never see his family again).
Emotional or Psychological Abuse: The infliction of anguish, pain, or distress through
verbal or nonverbal acts. Emotional/psychological abuse includes but is not limited to verbal
assaults, insults, threats, intimidation, humiliation, and harassment. In addition, treating an
older person like an infant; isolating an elderly person from his/her family, friends, or regular
activities; giving an elderly person the "silent treatment;" and enforced social isolation are
examples of emotional/psychological abuse.
Sexual Abuse: Non-consensual sexual contact of any kind with an elderly person. Sexual
contact with any person incapable of giving consent is also considered sexual abuse. It
includes, but is not limited to, unwanted touching, all types of sexual assault or battery, such
as rape, sodomy, coerced nudity, and sexually explicit photographing.
¹ National Center on Elder Abuse (n.d.) What is elder abuse? Retrieved from http://www.ncea.aoa.gov/faq/index.aspx

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PACE Level II Reporting Guidance
Physical Abuse: The use of physical force that may result in bodily injury, physical pain, or
impairment. Physical abuse may include but is not limited to such acts of violence as
striking (with or without an object), hitting, beating, pushing, shoving, shaking, slapping,
kicking, pinching, and burning. In addition, inappropriate use of drugs and physical
restraints, force-feeding, and physical punishment of any kind also are examples of physical
abuse.
Neglect: The refusal or failure to fulfill any part of a person's obligations or duties to an
elder. Neglect may also include failure of a person who has fiduciary responsibilities to
provide care for an elder (e.g., pay for necessary home care services) or the failure on the
part of an in-home service provider to provide necessary care. Neglect typically means the
refusal or failure to provide an elderly person with such life necessities as food, water,
clothing, shelter, personal hygiene, medicine, comfort, personal safety, and other essentials
included in an implied or agreed-upon responsibility to an elder.
Abandonment: The desertion of an elderly person by an individual who has assumed
responsibility for providing care for an elder, or by a person with physical custody of an
elder.
Financial or material exploitation: The illegal or improper use of an elder's funds, property,
or assets. Examples include, but are not limited to, cashing an elderly person's checks
without authorization or permission; forging an elderly person’s signature; misusing or
stealing an older person's money or possessions; coercing or deceiving an older person into
signing any document (e.g., contracts or will); and the improper use of conservatorship,
guardianship, or power of attorney.
Aggregate Data: Data combined from several measurements. This summary data is
obtained by totaling the single values from a collection of values meeting specific criteria.
For example, the aggregate for deaths of participants in a quarter for a PO would be the
total number of participant deaths from all causes during the specified three month period.
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 as Level
II incident 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-thecounter drugs, biologics, medical devices, and special nutritional products.

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PACE Level II Reporting Guidance
Adverse Participant Outcome: A serious, undesirable, and unexpected outcome
resulting from care or treatment.
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.
Note: For all participant deaths, POs must have an internal process to capture data on
each participant death and report this information in HPMS.
Elopement: Occurs when a participant wanders away or leaves a PACE-sponsored setting, a
participant’s home, a Skilled Nursing Facility, and Assisted living Facility without authorization
and presents a threat of safety to self and others. CMS acknowledges the right of a PACE
participant to leave the PACE center at will when mentally capable of doing so. Therefore,
the term elopement for the purposes of Level II Reporting is limited to participants whose
medical condition resulting in cognitive deficits or, to those who have been deemed legally
incapable of making their own decisions about complying with documented treatment plans.
Equipment or Device Related Occurrence: The failure of medical equipment or device to
perform in accordance to manufacture’s specifications or failure to operate equipment as
intended by the manufacturer. Common causes of medical equipment or device failure are
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;
as well as failure to report and remove defective equipment or devices from patient care
areas in order to ensure they are not used until they are replaced or repaired that results in
serious injury, serious illness, or death.
Fall: A sudden, uncontrolled, unintentional, non-purposeful downward displacement of the
body to the floor/ground, or hitting another object. Falls present several unique challenges
for reporting, such as confounding conditions or circumstances, the potential volume of
reporting, difficulty assessing the circumstances of a fall not witnessed or occurring outside
the PACE Center, and potential delay in identifying pathology causing or resulting from the
fall.

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PACE Level II Reporting Guidance
Fire/Other Disasters: An environmental event at a PACE-sponsored setting that requires
evacuation or unanticipated or sudden closure of a PO resulting in the inability to provide
care/disruption in care (i.e. tornado, bombing, earthquake), or results in a loss of safe
housing for PACE participants.
Food-borne outbreak: Three or more people get the same illness from the same
contaminated food or drink.
Improvement Activities: Activities undertaken by a PO in response to investigating unusual
participant incidents or to correct program deficits. The PO follows its quality improvement
processes and its policies and procedures. The quality improvement focus can be at the
organizational, provider team, or participant level. Examples include:
•
•
•

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

Infectious Disease Outbreak: Three or more cases of the same illness resulting from the
same source or infectious agent impacting participants in a PACE Center, contracted
facility, or other PACE housing arrangement resulting serious illness, hospitalization, or
death.
Media-related Incident: Any reporting through local, state, regional or national media
outlets (print, broadcast, web-based, radio, etc.) that presents a potential or actual
harmful characterization of a PO or the PACE program. The PO must notify its
contractual partners and sponsors, CMS and SAA, when adverse publicity that it is
aware of 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: Mistakes or errors that occur when prescribing,
dispensing, or administering a medication. POs 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 medication-related
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, or ambiguities in product names or directions for use.
Motor Vehicle Accident (MVAs): Applies to MVAs in which PACE participants are
transported, contracted/owned, or operated by PACE personnel. Report vehicle collision in
which the vehicle is transporting PACE participants to or from a PACE program-related
activity. Program related activities include travel to and from the PACE Center, and
community-based appointments, visits, and excursions.
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PACE Level II Reporting Guidance
Participant: Individual enrolled in a PACE program.
Pressure Ulcer: According to the National Pressure Ulcer Advisory Panel (NPUAP) a
pressure ulcer is a localized injury to skin and/or underlying tissue, usually over a bony
prominence, as a result of pressure, or pressure in combination with shear force and/or
friction. When determining the required level of reporting pressure ulcers, PACE
organizations should consider that most pressure ulcers managed for nursing home
residents heal within 60 days. The vast majority of pressure ulcers are preventable. POs
having difficulty determining whether a pressure ulcer requires Level II reporting should
consult with their CMS account manager and or submit their inquiry to
https://DMAO.LMI.org. PACE organizations should report stage III, IV, and unstageable
pressure ulcers that develop while enrolled in PACE. Please refer to for the NPUAP for
stage definitions: www.npuap.org.
Restraint: PACE regulations 42CFR §460.114 stipulate 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 of achieving a safe environment or safe participant behavior, PACE regulations
do permit the limited use of either a physical or chemical restraint.
Restraints can be either physical or chemical:
• Physical restraint--any manual method or physical or mechanical device, material, or
equipment attached or adjacent to the patient’s body that the participant cannot remove
easily and which restricts freedom of movement or normal access to one’s body.
Includes but not limited to leg restraints, arm restraints, hand mitts, soft ties or vests, lap
cushions, and lap trays the patient can’t remove easily.
• 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, 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.

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PACE Level II Reporting Guidance
Appendix B: References
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
• Infectious disease and foodborne outbreaks
• Injury, violence and safety
• Older adults and seniors health issues
• Research publications

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

Institute of Medicine
• Aging issues
• Healthcare and quality issues
• Research publications

http://www.iom.edu

The Joint Commission
• Participant safety
• Root Cause Analysis process
• Sentinel event alert reports

www.jointcommission.org

National Database of Nursing Quality Indicators
• Quality measures and indicators
• Research-based practice

http://www.nursingquality.org/

National Pressure Ulcer Advisory Panel
• Research and guidelines on pressure
ulcer management

http://www.npuap.org

National Institute of Aging
• Research publications
• Safety issues

http://www.nia.nih.gov

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PACE Level II Reporting Guidance
Pharmacy Related Resources:
•

Institute for Safe Medication Practices

http://www.ismp.org/

•

National Association of Boards of Pharmacy
Links to State Boards

http://www.nabp.net/

•

American Society of Consultant Pharmacists
(LTC Pharmacists)

http://www.ascp.com/

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