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

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CMS Releases New Resources for Clinical Laboratories Seeking Information About CLIA Certification During the Pandemic

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New CMS resources help new clinical laboratories to obtain CLIA certification

At the end of September 2020, the US Centers for Medicare and Medicaid Services (CMS) released guidelines and easy-access information regarding CLIA certification during the COVID-19 pandemic. While the reason for these new resources was not explicitly stated, they come at a time when the growth of point-of-care (POC) SARS-CoV-2 antigen testing has significantly expanded. This has triggered many entities to seek the CLIA certification that is needed to perform these POC tests.

Resources released by CMS include the Laboratory Quick Start Guide to CMS CLIA Certification, which outlines six steps clinical laboratories should follow. These include:

  1. Download and complete form CMS-116;
  2. Complete type of certificate requested in section II;
  3. Receive fee coupon (ie, invoice);
  4. Pay applicable fees;
  5. Receive laboratory certificate and begin testing; and
  6. Maintain certificate.

Clinical laboratory leaders can use the new CMS Laboratory Quick Start Guide to quickly understand the CLIA certification application process. Each step is explained in the guide.

In addition to the Laboratory Quick Start Guide, CMS also released a resource page, with links to more than a dozen information pages, including frequently asked questions on multiple topics, educational topics, and CMS articles that may be helpful.

Related Resources:

Laboratory Quick Start Guide to CMS CLIA Certification

CMS: Clinical Laboratory Improvement Amendments (CLIA) Resource Page

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