Issuance of Clinical Laboratory Improvement Amendments of 1988 (CLIA) State Agency Performance Review (SAPR)—Fiscal Year 2021 (FY 2021)

CLIA SAPR Review Protocol: The FY 2021 review is continuing the restructured, more streamlined, SAPR process introduced in FY 2019. • Goal: CLIA State Agency (SA) optimal 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” or “Written Corrective Action Plan” results will be reported on the Summary Report. The review year in FY 2021 is October 1, 2020 through September 30, 2021. • 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Subject Areas: CMS Branch Locations have the overarching responsibility and authority for SA oversight, which is not superseded nor limited by the CLIA SAPR.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 2021 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 Branch Manager by Friday, March 4, 2022.