Attn: CLIA Providers
CMS rescinds QSO-22-25-CLIA
CMS Rescinds December 7, 2020, Enforcement Discretion for the Use of SARS-CoV-2 Tests on Asymptomatic Individuals Outside of the Test’s Instructions for Use
Memorandum Summary
CMS issued CMS-22-25-CLIA rescinding 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.
Questions
For questions or concerns relating to this memorandum, please contact LabExcellence@cms.hhs.gov.
|
