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

CMS maze of rules and regulations

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