03/22/2021: Lab Update: CMS Posts FAQ for Reporting Sequencing Results for SARS-CoV-2 Variants

CDC's Laboratory Outreach Communication System (LOCS)

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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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)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: March 22, 2021