CMS issued QSO-22-25-CLIA this week, 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. The change in enforcement discretion is effective immediately and means that skilled nursing facilities and/or assisted living communities with a CLIA Certificate of Waiver must check that they are complying with the manufacturer’s instructions when using these tests, if they are not approved for use on asymptomatic individuals, stop using them and order new tests.

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.

Questions?

Contact:

Laura Hofmann, MSN, RN – Director of Clinical and Nursing Facility Regulatory Services
c: 425-231-4804