March 26 LOCS (CDC) Email

Audience: Clinical Laboratory Professionals
Subject: CMS Issues CLIA Guidance and FAQs for Laboratories During the COVID-19 Pandemic
Level: Laboratory Advisory

General Statement

Today, the Centers for Medicare & Medicaid Services (CMS) issued important guidance and frequently asked questions (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).

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