CMS-10630 Personnel Impact Analysis Template

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Overview

Instructions
Detailed Sample Information
Root Cause Analysis
Participant Impact

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Sheet 1: Instructions

Audit Review Period:
Issue(s) of non-compliance:	Auditors: Select All that Apply	Issue:
		Initial personnel competencies
		Personnel licensure
		OIG exclusion checks
		Criminal Convictions
		Communicable disease clearance
Scope:	Initial personnel competencies: • The scope of the Impact Analysis is no more than 50% of staff (including employees and contractors) during the audit review period who were not included in the personnel sample selection and meet the following criteria: 1. Were newly hired during the audit review period; and 2. Provided participant care in the PACE centers or participant homes. Personnel licensure: • The scope of the Impact Analysis is no more than 50% of staff (including employees and contractors) during the audit review period who were not included in the personnel sample selection and had direct participant contact in the PACE centers or participant homes. OIG exclusion checks: • The scope of the Impact Analysis is no more than 50% of staff (including employees and contractors) during the audit review period who were not included in the personnel sample selection and were newly hired during the audit review period. Criminal Convictions: • The scope of the Impact Analysis is no more than 50% of staff (including employees and contractors) during the audit review period who were not included in the personnel sample selection and were newly hired during the audit review period.
	Communicable disease clearance: • The scope of the Impact Analysis is no more than 50% of staff (including employees and contractors) during the audit review period who were not included in the personnel sample selection and meet the following criteria: 1. Were newly hired during the audit review period; and 2. Had direct participant contact in the PACE centers or participant homes.
Instructions:	General: • 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 RCA tab. • Respond to the questions in the Participant Impact tab.
Impact Analysis Due Date:
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 0938-1327. This information collection will allow CMS to conduct comprehensive reviews of PACE organizations to ensure compliance with regulatory requirements. The time required to complete this information collection is estimated at 780 per response, including the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection. This information collection is mandatory per CMS’s authority under Section 1894 and 1934 of the Social Security Act and implementing regulations at 42 CFR § 460.190 and 460.194, which state that CMS, in conjunction with the State Administering Agency (SAA), audit PACE organizations (POs) annually for the first 3 contract years (during the trial period), and then on an ongoing basis following the trial period. Additionally, per § 460.200(a) PACE organizations are required to collect data, maintain records, and submit reports as required by CMS and the State administering agency. 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.

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Sheet 2: Detailed Sample Information

Tracking ID Number	Brief Description Of Issue (Completed By The CMS Audit Lead)	Type of Issue Identified (Completed By The CMS Audit Lead) (Applies to condition 1P.02 Only. For all other conditions enter N/A)	Detailed Description of the Issue (Explain what happened)
		x

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Sheet 3: Root Cause Analysis

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

Section 1 - General Information: This information is to be completed for all Impact Analyses

Section 2 - This information is to be completed if the Impact Analysis is being requested for: Initial personnel competencies

Section 3 - This information is to be completed if the Impact Analysis is being requested for: Personnel licensure

Section 4 - This information is to be completed if the Impact Analysis is being requested for: OIG exclusion checks

Section 5 - This information is to be completed if the Impact Analysis is being requested for: Criminal Convictions

Section 6 - This information is to be completed if the Impact Analysis is being requested for: Communicable disease clearance

Section 7 - General Information: This information may be completed for all Impact Analyses

Employee First Name

Employee Last Name

Job Title

Date of Hire MM/DD/YYYY

Date of Termination MM/DD/YYYY Enter NA if employee was not terminated during audit review period.

Type of Employment Enter contract, Full-time, Part-time, Volunteer, or Other.

Direct Participant Contact (Yes/No)

License (Yes/No)

Is there documentation that the staff member's competency was evaluated prior to them providing participant care independently? (Yes/No) *This requirement only applies to personnel newly hired during the audit review period. If the auditor did not select Initial personnel competencies on the instructions tab the PO may enter NA in all columns in section 2. Enter NA in all columns in section 2 if the individual did not provide participant care independently during the audit review period.

Date Individual Began Providing Care Independently MM/DD/YYYY

Date of competency evaluation completed. MM/DD/YYYY Enter Not Completed if the competency evaluation was never done.

Is the individual (employee or contractor) required to have a license in order to perform care and/or services in the PO's state? (Yes/No) *This requirement applies to all personnel. If the auditor did not select Personnel licensure on the instructions tab the PO may enter NA in all columns in section 3. If the answer to this question is No enter NA in all remaining columns in section 3.

Type of license(s) required? *This requirement applies to all personnel.

Is there documentation that the staff member had a valid license for the duration of the audit review period? (Yes/No) *This requirement applies to all personnel.

Is there documentation that an OIG exclusion check was completed before the date of hire? (Yes/No) *This requirement only applies to personnel newly hired during the audit review period. If the auditor did not select OIG exclusion checks on the instructions tab the PO may enter NA in all remaining columns in section 4.

Date the OIG check was completed. MM/DD/YYYY Enter Not Completed if the OIG check was never completed.

Is there documentation that a background check was completed before the date of hire? (Yes/No) *This requirement only applies to personnel newly hired during the audit review period. If the auditor did not select Background checks on the instructions tab the PO may enter NA in all remaining columns in section 5.

Date the background check was completed. MM/DD/YYYY Enter Not Completed if the background check was never completed.

Is there documentation the individual (employee or contractor) was cleared of communicable diseases prior to engaging in direct participant contact? (Yes/No) Enter NA if the individual did not have direct participant contact during the audit review period. *This requirement only applies to personnel newly hired during the audit review period. If the auditor did not select Communicable disease clearance on the instructions tab the PO may enter NA in all remaining columns in section 6. If the answer to this question is NA, enter NA in all remaining columns in section 6.

Date of Initial Participant Contact MM/DD/YYYY

Was a risk assessment completed before the individual engaged in direct participant contact? (Yes/No)

Date risk assessment was completed MM/DD/YYYY Enter NA if a risk assessment was not completed.

Did the risk assessment determine if the individual was exposed to or had any symptoms of the following diseases: (i) COVID–19, (ii) Diphtheria, (iii) Influenza, (iv) Measles, (v) Meningitis, (vi) Meningococcal Disease, (vii) Mumps, (viii) Pertussis, (ix) Pneumococcal Disease, (x) Rubella, (xi) Streptococcal Infection, (xii) Varicella Zoster Virus, (xiii) any other infectious diseases noted as a potential threat to public health by the CDC? (Yes/No) Enter NA if a risk assessment was not completed.

Were the results of the risk assessment reviewed by a registered nurse, physician, nurse practitioner, or physician assistant? (Yes/No) Enter NA if a risk assessment was not conducted.

Did the risk assessment indicate that a physical exam was needed? (Yes/No) Enter NA if a risk assessment was not conducted.

Was a physical exam completed before the individual engaged in direct participant contact? (Yes/No)

Date physical exam was completed. MM/DD/YYYY Enter NA if a physical exam was not completed.

Was the physical exam completed by a physician, nurse practitioner, or physician assistant? (Yes/No) Enter NA if a physical exam was not conducted.

Was the individual determined to be free of active Tuberculosis disease? *This question applies regardless of whether a risk assessment or physical examination was completed. (Yes/No)

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 staff member please enter the information in this column.