11/12/2020: Lab Update: CMS IQCP Clarification for EUA Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Update

The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a statement in response to the recent confusion regarding quality control for tests with FDA emergency use authorization (EUA). See below for the statement from CMS:

“The manufacturer’s instructions for all tests that have authorization for use as EUA must be followed, to include quality control (QC). Surveyors will ensure that the laboratory is following the EUA Instructions for Use (IFU) as well as its own established policies, specifically its QC procedures. QC for EUAs must be followed, and no deviations to the QC requirements in the EUA are permitted; Individualized Quality Control Plan (IQCP) is not applicable to EUAs.  Please note: The laboratory director may determine, based on risk assessment, that additional QC needs to be implemented above what is required in the EUA IFU. Please also note: States and Accreditation Organizations (AOs) may have more stringent requirements.”

In addition, on Tuesday, November 10, CMS updated the Clinical Laboratory Improvement Amendments (CLIA) frequently asked questions (FAQ) document to provide further clarification on IQCP and added several new FAQs regarding CLIA certificates. Click here to view the document.

Online resources:

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

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)