CMS IQCP Clarification for EUA Tests

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below is a link to the most recent message about CMS Individualized Quality Control Plan (IQCP) clarification for EUA tests.

CMS IQCP Clarification for EUA Tests

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.”

Click here to read more.