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

COVID-19 Briefings

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

CMS Allows Clinical Laboratories to Perform Testing While Awaiting CLIA Certificate of Waiver Approval

CMS maze of rules and regulations
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New CMS temporary enforcement discretion allows clinical laboratories greater flexibility when applying for a CLIA Certificate of Waiver

The US Centers for Medicare and Medicaid Services (CMS) recently released guidance for clinical laboratories that have applied for a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver (CoW) and want to know at what point they can begin testing. This guidance applies specifically to the CMS-116 application for a CLIA Certificate of Waiver.

CMS provides guidance to clinical laboratories on this issue, stating, “CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 POC testing when a facility has submitted a CMS-116 application for a CLIA CoW, but has not yet been assigned a CLIA number. Specifically, facilities that have applied for a CLIA CoW to perform SARS-CoV-2 POC testing … can begin SARS-CoV-2 POC testing and reporting patient-specific results as soon as they have submitted their application to their State Agency (SA). A non-certified facility will be treated as operating under CoW while their application is being processed.”

CMS notes that this temporary enforcement discretion does not mean that normal CLIA requirements are being loosened outside this specific guidance. CMS also encourages laboratories to consider that their state agencies may have additional licensure requirements that must be met before they can begin testing.

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