CMS-10630 Clinical Appropriateness and Care Planning Impact Analys

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Overview

Instructions
Root Cause Detail
Root Cause Summary
Participant Impact

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Sheet 1: Instructions

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 RCA tab.
Impact Analysis Due Date:

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Sheet 2: Root Cause Detail

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

Detailed Description of the Issue (Explain what happened)

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Sheet 3: Root Cause Summary

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)

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

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

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

Actions Taken to Resolve Negatively Impacted Individuals Including Outreach Description and Status

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

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

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Sheet 4: Participant Impact

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 its 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

Medicare Beneficiary Identifier

Participant ID

Date of Enrollment MM/DD/YYYY

Date of Disenrollment MM/DD/YYYY Enter NA if the participant is still enrolled.

Did the participant experience a medication error during the audit review period? (Yes/No) If NO, enter NA in columns H through V.

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 MM/DD/YYYY Enter NA if the medication has not been discontinued.

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)

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

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

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

Did a medication error occur due to ineffective communication with or oversight of a contracted provider? (Yes/No)

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)

If yes, describe the negative outcomes. Enter NA if the participant did not experience negative outcomes.

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