On February 6, 2020, CMS published QSO 20-10-CLIA.

Key Points:

  • The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and the corresponding protocols have been developed by the CDC for use by CDC qualified laboratories and the assay has been issued an Emergency Use Authorization (EUA) from the FDA.
  • Upon receipt of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and corresponding Manufacturer’s Instructions (MI), CDC qualified laboratories will verify assay performance specifications in their laboratory per the manufacturer’s instructions.
  • Surveyors are to notify their CMS Location if they discover a laboratory using an assay without an EUA that is testing for the same agent for which the emergency has been declared, or a modified EUA assay. The CMS Location will notify CMS Baltimore.

Are any HFAP Standards affected by this change?

No. This notice is provided for your information only.

The complete document can be viewed at QSO 20-10 CLIA.