Issuance of Clinical Laboratory Improvement Amendments of 1988 (CLIA)
State Agency Performance Review (SAPR)-Fiscal Year 2019 (FY 2019)

• CLIA SAPR Review Protocol: The FY 2019 review introduces a restructured, more
streamlined, SAPR process.
• Goal: CLIA State Agency (SA) optimal performance, with support from the Centers
for Medicare & Medicaid Services (CMS) Regional Offices (ROs), as necessary.
• Summary Report for Each CLIA SA: The aim of each report is a balanced picture of
the CLIA SA’s operations. The CLIA SAPR review for FY 2019 is educational due
to the new process; therefore, no SA “Performance Thresholds for Written
Corrective Action Plan”, “Quantified Performance Results” or “Written
Corrective Action Plan” results will be reported on the Summary Report.
• Review of Other Subject Areas: CMS ROs 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authority for SA oversight, which is not superseded nor limited by the CLIA SAPR.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 2019 Review Criteria may also be
reviewed at the RO’s discretion.
• Due Date: Draft CLIA SAPR Summary Reports, Worksheets, Cover Letters and RO
Review Tools are due in Central Office (CO) by March 6, 2020.