The Centers for Medicare & Medicaid Services (CMS) Director, Quality, Safety & Oversight Group (QSOG) published a memo on September 26 to the State Survey Agency Directors regarding the Clinical Laboratory Improvement Amendments of 1988 (CLIA) State Agency Performance Review (SAPR) for Fiscal Year 2024 (FY 2024).
Memorandum summary:
· The Centers for Medicare & Medicaid Services (CMS) is releasing the FY 2024 guidance for the State Agency Performance Review (SAPR).
· CLIA SAPR Review Protocol: The FY 2024 review has been updated from FY 2023. Three documents are being updated to improve readability and ease by which SAs may complete the templates: the FY 2024 SAPR Excel Workbook, the FY 2024 Summary Report, and the FY 2024 CLIA SAPR Cover Letter CAP Resp Template.
· Goal: The purpose of the SAPR is to ensure optimal State Agency (SA) performance to improve quality in patient laboratory testing and promote health and safety.
· Review of Other Subject Areas: CMS’s Division of Clinical Laboratory Improvement and Quality (DCLIQ) has the overarching responsibility and authority for SA oversight, which is neither superseded nor limited by the CLIA SAPR.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 FY 2024 Review Criteria may also be reviewed at CMS DCLIQ’s discretion.
The CLIA SAPR review for FY 2024 includes SA “Performance Thresholds for Written Corrective Action Plan,” “Quantified Performance Results,” and “Written Corrective Action Plan” results on the Summary Report. CMS DCLIQ SAO Branch has the option to expand the review to include additional areas of CLIA SA responsibilities which, in their judgment, merits evaluation or monitoring.
The eight criteria for FY 2024 are:
· Criterion #1 - Personnel Qualifications, Training, and Competency
· Criterion #2 - Data Management
· Criterion #3 - Proficiency Testing (PT) Desk Review
· Criterion #4 - Principles of Documentation (PoD), Plan of Correction (PoC)/Allegation of Compliance (AoC)
· Criterion #5 - Survey Workload and Outcome-Oriented Survey Process (OOSP)
· Criterion #6 - Complaints
· Criterion #7 - Quality Assessment
· Criterion #8 – Budget
