Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analys

Audit Review Period:
Issue of non-compliance:

Restraints

Scope:

• The scope of this Impact Analysis is limited to 50% of the participants enrolled during the audit review period who were not included in the provision of
services sample selection.
• The auditor will select the participants to be reviewed and enter their identifying information on the Participant Impact tab.

Instructions:

• Review only the participant medical records selected by the auditor. The selected participants are identified in the Participant Impact tab.
• Review the selected medical records to determine if restraints were utilized for any participants.
• Read each question carefully before responding.
• Respond to the questions in the participant impact tab.
• The review timeframe is the audit review period. Errors noted prior to the audit review period should not be included.
• After completing the Impact Analysis, if any changes need to be made to the Root Cause Analysis, please update the changes in the RCA tab.

Impact Analysis Due Date:

Date Identified
(MM/DD/YY)
(Completed By The CMS
Audit Lead)

Brief Description Of Issue
(Completed By The CMS Audit Lead)

Condition Language
(Completed By The CMS Audit Lead)

Pending OMB Approval (0938-New)

Detailed Description of the Issue
(Explain what happened)
(Remaining fields to be Completed by PACE Organization)

Root Cause Analysis for the Issue
(Explain why it happened)

Methodology - Describe the process that
was undertaken to determine the # of
individuals (e.g. participants) impacted

Pending OMB Approval (0938-New)

# of Individuals
Impacted

Action Taken to Resolve System/
Operational Issues

Date System/ Operational Remediation Date System/ Operational Remediation Actions Taken to Resolve Negatively Impacted Individuals Date Individual Outreach and Remediation
Completed (MM/DD/YY)
Including Outreach Description and Status
Initiated
Initiated
(MM/DD/YY)
(MM/DD/YY)

Pending OMB Approval (0938-New)

Date Individual Outreach and
Remediation Completed
(MM/DD/YY)

For the purpose of this Impact Analysis, restraints are defined as: (1) A physical restraint is any manual method or physical or mechanical device, materials, or equipment attached or adjacent to the
participant's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body. (2) A chemical restraint is a 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.
Participant First Name

Participant Last Name

Participant ID

Date of Enrollment

Date of Disenrollment

MM/DD/YYYY

MM/DD/YYYY

Reason for Disenrollment

Were any physical devices, materials, or equipment used to restrict Describe the type of physical restraint.
the participant's movement at any point during the audit review
period?
Enter NA if no physical restraints were used.
(Yes/No)
If the answer to this question is no the PO may enter NA in all
remaining fields.

Were any medications used to control behavior or Describe the type of chemical restraint.
to restrict the participant's freedom of movement
that is not a standard treatment for the
Enter NA if chemical restraints were not used.
participant's medical or psychiatric condition?
(Yes/No)

Was a physician's order for the chemical restraint Were any less restrictive methods utilized prior to
obtained prior to administration of the
the use of physical or chemical restraints?
medication?
(Yes/No)
(Yes/No)
Enter NA if physical and chemical restraints were
Enter NA if chemical restraints were not used.
not used.

Describe the less restrictive methods utilized prior to
the use of physical or chemical restraints.
Enter NA if physical and chemical restraints were not
used.

Describe how it was determined that a physical or chemical restraint was
necessary.

Date the restraint was initiated.

Time the restraint was initiated.

MM/DD/YYYY

Enter NA if no restraints were utilized.

Enter NA if no restraints were utilized.

Was an assessment conducted to determine Based on the assessment, how long was the How frequently was the participant
how long the restraint was needed?
restraint needed?
monitored while the restraint was applied?
(Yes/No)
Enter NA if no restraints were utilized.

Enter NA if no restraints were utilized or if
no assessment was completed.

Enter NA if no restraints were utilized.

Date the restraint was discontinued.

Time the restraint was discontinued.

MM/DD/YYYY

Enter NA if no restraints were utilized. (Yes/No)

Enter NA if no restraints were utilized.

Were the PO's policies and procedures followed?

Enter NA if no restraints were utilized.

If the participant experienced negative
outcomes, did they occur, in some part, as a
result of the use of restraints?
(Yes/No)

If yes, describe the negative outcomes.

Optional: Please note, you do not have to complete this column.

Enter NA if the participant did not experience negative outcomes.

If there are any mitigating factors that you would like CMS to consider related to a
specific participant, please enter the information in this column.