QSO-22-25-CLIA
DATE: September 26th, 2022
TO: State Survey Agency Directors FROM: Director, Quality, Safety & Oversight Group (QSOG)
SUBJECT: CMS Rescinds December 7, 2020, Enforcement Discretion for the Use of SARS CoV-2
Memorandum Summary
CMS is issuing this memorandum to rescind the December 7, 2020 guidance regarding the enforcement discretion under CLIA for the use of tests for SARS-CoV-2 on asymptomatic individuals outside of the test’s authorization, when an Emergency Use Authorization has been granted by the FDA.
EFFECTIVE IMMEDIATELY:
• CMS is rescinding the enforcement discretion that allowed Certificate of Waiver labs to perform SARS-CoV-2 molecular and antigen Point of Care (POC) tests on asymptomatic individuals outside of the test’s authorization.
• CMS is also rescinding the enforcement discretion that allowed non-waived labs to perform SARS-CoV-2 molecular and antigen tests on asymptomatic individuals outside of the test’s authorization without establishing performance specifications.
• All CLIA certified laboratories are required to follow the manufacturer’s instructions for use with regards to the intended use for SARS-CoV-2.
• In order to use any test for SARS-CoV-2 outside of the test’s authorization, a laboratory must be a high-complexity laboratory.
• In addition, the laboratory must establish performance specifications as required by the CLIA regulations at 42 CFR 493.1253 before reporting patient test results.