Issuance of Clinical Laboratory Improvement Amendments of 1988 (CLIA)
State Agency Performance Review (SAPR)-Fiscal Year 2018 (FY2018)

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Title
Issuance of Clinical Laboratory Improvement Amendments of 1988 (CLIA)
State Agency Performance Review (SAPR)—Fiscal Year 2018 (FY2018)
Memo #
18-20-CLIA
Posting Date
2018-09-28
Fiscal Year
2018
Summary
• CLIA SAPR Review Protocol: The FY 2018 review is limited to eight criteria.
• Summary Report for Each CLIA SA: The aim of each report is a balanced picture of the CLIA SA’s operations, including activities the SA performs well, area(s) where improvement may be needed, noteworthy accomplishments, and any special circumstances affecting performance.
• Review of Other Subject Areas: CMS ROs have the overarching responsibility and authority for SA oversight, which is not superseded nor limited by the CLIA SAPR.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 2018 Review Criteria may also be
reviewed at the RO’s discretion.
• Review of CLIA SAPR Criterion 4: The RO Review Tool has been updated based on RO reviewer feedback (See Attachment #1).
• Review of CLIA SAPR Criterion 10: The RO Review Tool for Criterion 10, POD Principle 3 is utilized again this year, with slight modification, based on RO reviewer feedback. (See Attachment #1).
• Due Date: Draft CLIA SAPR Summary Reports, Worksheets, Cover Letters and RO Review Tools are due in Central Office (CO) by March 8, 2019.