March 31, 2020

CMS Offers Guidance on Expedited CLIA Certification

Laboratories that perform tests on human materials for the purpose of diagnosis are considered laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and must receive CLIA certification. Basic elements of certification include (1) the submission of an application and (2) compliance with statutorily dictated “accuracy, quality, and reliability requirements.” Specified state survey agencies process CLIA certification applications for the federal CLIA program. For more application instructions, see CMS: How to Apply for a CLIA Certificate, Including International Laboratories. (Please note that Washington State applicants “should not complete the CMS-116 form but should contact the Washington State Agency at (253) 395-6746 for guidance.”)

The Centers for Medicare and Medicaid Services (CMS) issued guidance on March 26, 2020, that details an expedited CLIA certification process applicable during the COVID-19 public health emergency. This guidance is relevant for laboratories that (1) want to test for COVID-19, but (2) are still in the process of applying for CLIA certification or have not yet applied. CMS wants to ensure that these laboratories “are able to begin testing as quickly as possible during the public health emergency.”

The new guidance does not waive the requirement that all laboratories need a CLIA certificate if they are to perform COVID-19 testing. CMS does not have the authority to “grant waivers or exceptions that are not established in statute or regulation” in the area of CLIA certification. However, CMS can provide for an expedited CLIA certification application process.

There are no changes to the information required in the expedited application process — only a timing shortcut. In its guidance, CMS highlights the major components of the application process: (1) the identification of a qualified laboratory director and (2) a completed CMS-116 application. Once the state survey agency determines that it has received complete application information, it assigns a CLIA number to the approved laboratory. Under normal circumstances, the approved laboratory cannot begin any testing that requires CLIA certification until a hard copy certificate arrives in the mail. Under the new guidance, the approved laboratory may begin such testing as soon as the CLIA number is assigned, as long as applicable CLIA requirements have been met. Initial indications are that state survey agencies have been very responsive to applications received under the expedited process.

Other key takeaways regarding CLIA certification guidance:

  • All guidance in the new memorandum is effective immediately and “is applicable only during the COVID-19 public health emergency.”
  • Laboratories must still comply with any state laws governing laboratories, “which may be more stringent than CLIA.”
  • CMS is exercising enforcement discretion and “will not enforce the requirement to have a separate certificate for laboratories that are located at a temporary testing site, provided that the designated primary site or home base has such a certificate (using the address of the primary site) and the work being performed in the temporary testing site falls within the parameters of the primary site’s certificate.”

Hospital/university hospital campus laboratories that are located in “contiguous buildings on the same campus and under common direction (meaning that all testing sites are under one designated director) may hold a single certificate for the laboratory sites within the same physical location or street address.”

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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