Dynamic List Information
Dynamic List Data
Title
Issuance of Clinical Laboratory Improvement Amendments of 1988 (CLIA) State Agency Performance Review (SAPR)—Fiscal Year 2023 (FY 2023)
Memo #
23-16-CLIA
Posting Date
2023-09-29
Fiscal Year
2023
Summary
Memorandum Summary
• CLIA SAPR Review Protocol: The FY 2023 review has been updated from FY 2022. We are introducing a new performance indicator in criterion #5 (educational only), a new Criterion #8, Budget (educational only), and requirements for running and monitoring mandatory and quarterly reports beginning in October 2023.
• Goal: To ensure optimal CLIA State Agency (SA) performance with support from the Centers for Medicare & Medicaid Services (CMS) Branch Locations, as necessary.
• Summary Report for Each CLIA SA: The aim of each report is a balanced picture of the CLIA SA’s operations. The SA “Performance Thresholds for Written Corrective Action Plan,” “Quantified Performance Results” and “Written Corrective Action Plan” results will be reported on the Summary Report. The review year in FY 2023 is October 1, 2022, through September 30, 2023.
• Review of Other Subject Areas: CMS Branch Locations have the overarching responsibility and authority for SA oversight, which is not superseded nor limited by the CLIA SAPR. Subject areas not specifically addressed by the FY 2023 Review Criteria may also be reviewed at the CMS Branch Location’s discretion.
• Due Date: Draft CLIA SAPR Summary Reports, Worksheets and Cover Letters are due to the applicable Operations Branch Manager by Friday, March 1, 2024.
• CLIA SAPR Review Protocol: The FY 2023 review has been updated from FY 2022. We are introducing a new performance indicator in criterion #5 (educational only), a new Criterion #8, Budget (educational only), and requirements for running and monitoring mandatory and quarterly reports beginning in October 2023.
• Goal: To ensure optimal CLIA State Agency (SA) performance with support from the Centers for Medicare & Medicaid Services (CMS) Branch Locations, as necessary.
• Summary Report for Each CLIA SA: The aim of each report is a balanced picture of the CLIA SA’s operations. The SA “Performance Thresholds for Written Corrective Action Plan,” “Quantified Performance Results” and “Written Corrective Action Plan” results will be reported on the Summary Report. The review year in FY 2023 is October 1, 2022, through September 30, 2023.
• Review of Other Subject Areas: CMS Branch Locations have the overarching responsibility and authority for SA oversight, which is not superseded nor limited by the CLIA SAPR. Subject areas not specifically addressed by the FY 2023 Review Criteria may also be reviewed at the CMS Branch Location’s discretion.
• Due Date: Draft CLIA SAPR Summary Reports, Worksheets and Cover Letters are due to the applicable Operations Branch Manager by Friday, March 1, 2024.