Issuance of Clinical Laboratory Improvement Amendments of 1988 State Agency Performance Review —Fiscal Year 2020 (FY 2020)

• CLIA SAPR Review Protocol: The FY 2020 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. Due to the Public Health Emergency (PHE) and resulting prioritization of surveys starting March, 27, 2020, the review year has been shortened in FY 2020 to October 1, 2019 through March 1, 2020. • 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Subject Areas: CMS Branch Locations have the overarching responsibility and authority for SA oversight, which is not superseded nor limited by the CLIA SAPR.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 2020 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 March 5, 2021.