CDC LOCS Lab Update: CMS Posts FAQ for Reporting Sequencing Results for SARS-CoV-2 Variants

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.

Please share this message with your networks and invite them to opt in to LOCS to receive future updates. 

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 LOCS@cdc.gov.

This Lab Update was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.