03/26/2020: Lab Advisory: CMS Issues CLIA Guidance for Laboratories Performing COVID-19 Testing

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

CMS Issues CLIA Guidance for Laboratories Performing COVID-19 Testing

General Statement

Today, the Centers for Medicare & Medicaid Services (CMS) issued important guidanceexternal icon and frequently asked questionspdf iconexternal icon (FAQs) to help ensure that clinical laboratories in the United States are prepared to respond to the coronavirus disease (COVID-19) pandemic, while at the same time making sure they can fulfill CLIA requirements. This guidance provides information related to remote reviewing of pathology slides, proficiency testing, alternate collection devices, and requirements for obtaining a Clinical Laboratory Improvement Amendments (CLIA) certificate during a public health emergency. CMS is exercising some flexibilities during this time. However, the agency does not have the authority under the CLIA program to approve waivers (which allow for program modifications).

Online resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Laboratory Outreach Communication System | 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 27, 2020