03/22/2021: Lab Update: CMS Posts FAQ for Reporting Sequencing Results for SARS-CoV-2 Variants
Audience: Clinical Laboratory Professionals
Level: Laboratory Update
On March 19, 2021, the U.S. Centers for Medicare & Medicaid Services (CMS) posted the “CLIA SARS-CoV-2 Variant Testing Frequently Asked Question” document to provide information for facilities that perform sequencing to identify SARS- CoV-2 genetic variants.
CMS will not cite CLIA-certified laboratories that perform SARS-CoV-2 genetic variant testing on identified specimens and report patient-specific variant results to state or local public health departments without establishing performance specifications as required by §493.1253(b)(2), provided that the laboratory only reports patient-specific results to a public health department and the results are not intended to be used for purposes of an individual’s diagnosis, prevention, treatment, or health assessment.
If at any time the SARS-CoV-2 genetic variant result is intended to be used for purposes of an individual’s diagnosis, prevention, treatment, or health assessment, the test must be performed in a CLIA-certified laboratory and in compliance with all applicable CLIA regulations.
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Online resources:
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC Coronavirus (COVID-19) Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
If you have any questions, please contact us at LOCS@cdc.gov.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)