COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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CMS Updates CLIA FAQ Guidance for Clinical Laboratories

CMS maze of rules and regulations

New CMS guidance update addresses quality control requirements for COVID-19 tests

The Centers for Medicare and Medicaid Services (CMS) recently provided guidance to clinical laboratories for questions concerning their CLIA obligations pertaining to COVID-19 testing. This document, the “Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency,” was updated Dec. 17, 2020, to update or change the answers for three of the frequently asked questions that CMS addressed.

The first change was to the question, “Does ‘CLIA-waived’ mean that a facility does not have to have a CLIA certificate?”. This change was the most minor of the three changes and addresses the fact that CMS is exercising temporary enforcement discretion under CLIA for some types of surveillance testing.

The second change was perhaps the most significant and changed the answer to the question, “Can a laboratory develop an Individualized Quality Control Plan (IQCP) for COVID- 19 test systems?”. Previously, CMS had indicated that this was not necessary, and the quality controls described in the EUA were sufficient. The most recent change takes into consideration that lab directors may find it necessary to institute quality controls beyond those described in the EUA instructions for use.

The third change was in response to the question, “Has the FDA authorized any EUA tests for COVID-19 for at-home testing?”. This change reflects that at-home testing is now available. While three at-home tests had received EUAs at the time of CMS’ update, two of those were issued in the 48 hours prior to the update and are not included in the new CMS’ responses.

Clinical laboratory leaders wishing to view the CMS changes in more detail can do so here.

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