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

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

CMS Updates CLIA FAQ Guidance for Clinical Laboratories

CMS maze of rules and regulations
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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.

Related Resource:

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group