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Dynamic List Data
Title
Issuance of Clinical Laboratory Improvement Amendments of 1988 (CLIA) State Agency Performance Review (SAPR)— Calendar Year (CY) 2025
Memo #
Admin Info: 25-09-CLIA
Posting Date
2025-07-11
Fiscal Year
2025
Summary
Memorandum Summary
The Centers for Medicare & Medicaid Services (CMS) is releasing the CY 2025 guidance for the State Agency Performance Review (SAPR). The SAPR has been changed from a Fiscal Year (FY) to a CY schedule. Historically, this review was performed after the end of the prior FY. For CY 2025, the SAPR will consist of five quarters – 4th quarter of CY 2024, and quarters 1 through 4 of CY 2025. This shift will allow us to:
• Improve transparency: By reviewing SA performance and providing feedback on a quarterly basis, CMS can ensure timely review and response, and consistent alignment with the CLIA program's goals and mission.
• Enhance collaboration: Quarterly reviews will provide an opportunity to address challenges and celebrate successes in real time.
• Increase efficiency: Quarterly reviews will allow SAs and CMS to quickly adapt to any CMS program changes and facilitate SA performance.
CLIA SAPR Review Protocol:
The 2025 SAPR has been modified as follows:
• Criterion (CR) #1: The State Agency (SA) must notify CMS within 30 days of the end of the quarter of all CLIA staff changes.
• CR #2: An additional field on Form CMS-116 (email address) will be reviewed.
• CR #4: CMS will review at least one Form CMS-2567 for adherence to Principles of Documentation (POD), and at least one Plan of Correction (POC) or Allegation of Compliance (AOC) for acceptability, written or accepted by each surveyor.
• CR #5: The SA must provide CMS all required data reports, including evidence of review and all follow-up actions taken. Additionally, all states that have a backlog of overdue surveys must submit, quarterly, their plan to complete all overdue surveys.
• CR #7: SA written procedures must follow all written guidance from CMS.
• CR #8: Submission of Form CMS-105, and submission of Workload reports are no longer required.
Review of Other Subject Areas:
• CMS has the overarching responsibility and authority for SA oversight, which is neither superseded nor limited by the CLIA SAPR. Subject areas not specifically addressed by the CY 2025 Review Criteria may also be reviewed at CMS’s discretion.
The Centers for Medicare & Medicaid Services (CMS) is releasing the CY 2025 guidance for the State Agency Performance Review (SAPR). The SAPR has been changed from a Fiscal Year (FY) to a CY schedule. Historically, this review was performed after the end of the prior FY. For CY 2025, the SAPR will consist of five quarters – 4th quarter of CY 2024, and quarters 1 through 4 of CY 2025. This shift will allow us to:
• Improve transparency: By reviewing SA performance and providing feedback on a quarterly basis, CMS can ensure timely review and response, and consistent alignment with the CLIA program's goals and mission.
• Enhance collaboration: Quarterly reviews will provide an opportunity to address challenges and celebrate successes in real time.
• Increase efficiency: Quarterly reviews will allow SAs and CMS to quickly adapt to any CMS program changes and facilitate SA performance.
CLIA SAPR Review Protocol:
The 2025 SAPR has been modified as follows:
• Criterion (CR) #1: The State Agency (SA) must notify CMS within 30 days of the end of the quarter of all CLIA staff changes.
• CR #2: An additional field on Form CMS-116 (email address) will be reviewed.
• CR #4: CMS will review at least one Form CMS-2567 for adherence to Principles of Documentation (POD), and at least one Plan of Correction (POC) or Allegation of Compliance (AOC) for acceptability, written or accepted by each surveyor.
• CR #5: The SA must provide CMS all required data reports, including evidence of review and all follow-up actions taken. Additionally, all states that have a backlog of overdue surveys must submit, quarterly, their plan to complete all overdue surveys.
• CR #7: SA written procedures must follow all written guidance from CMS.
• CR #8: Submission of Form CMS-105, and submission of Workload reports are no longer required.
Review of Other Subject Areas:
• CMS has the overarching responsibility and authority for SA oversight, which is neither superseded nor limited by the CLIA SAPR. Subject areas not specifically addressed by the CY 2025 Review Criteria may also be reviewed at CMS’s discretion.