CMS-10630 Clinical Appropriateness and Care Planning Impact Analys

Audit Review Period:
Issue of non-compliance:

Medication errors

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 any medication errors occurred.
• Respond to the questions in the participant impact tab.
• The review timeframe is the audit review period. Errors noted before or after 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

# of Individuals
Impacted

Action Taken to Resolve System/
Operational Issues

Pending OMB Approval (0938-New)

Date System/ Operational Remediation Date System/ Operational Remediation
Initiated
Completed (MM/DD/YY)
(MM/DD/YY)

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

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

Pending OMB Approval (0938-New)

For the purpose of this Impact Analysis, a medication error is defined as: any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication is in the control of the PACE Organization or one of it's contracted providers. Such events may be related to
professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.
Participant First Name

Participant Last Name

Participant ID

Date of Enrollment

Date of Disenrollment

MM/DD/YYYY

MM/DD/YYYY

Did the participant experience a medication error during the
audit review period?
(Yes/No)
If NO, the PO may enter NA in all remaining fields.

Pending OMB Approval (0938-New)

Medication Name
List each medication that was associated with a medication error
in a new row.

Medication Dosage

Medication Route

Medication Frequency

Medication Start Date

Medication Discontinue Date
Enter NA if the medication has not been discontinued.

Pending OMB Approval (0938-New)

Describe the type of Medication Error
(Examples: Did not give medication, Gave wrong
medication, etc.)

In what setting was or should the medication have been
administered? (PACE Center, SNF, ALF, Home)

Pending OMB Approval (0938-New)

Date the Medication Error Began (First occurrence of the Date the Medication Error Ended (Last Occurrence of
the medication error)
medication error)
MM/DD/YYYY

How many doses of medication were provided or
omitted in error between the first and last date?

MM/DD/YYYY

If the participant experienced negative outcomes, did
they occur, in some part, as a result of the failure to
provide the item or service?
(Yes/No)

Pending OMB Approval (0938-New)

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.

Pending OMB Approval (0938-New)