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CMS Releases FAQs for CLIA Certificates and University Laboratories

CMS maze of rules and regulations

New clarification provided by CMS for CLIA considerations for university laboratories

The US Centers for Medicare and Medicaid Services (CMS) released guidance for Clinical Laboratory Improvement Amendments (CLIA) requirements and regulatory information for university laboratories. This guidance was issued in the form of a questions and answers document and was made available on Aug. 31, 2020.

The CMS CLIA guidance addressed three questions: 

  1. For a facility’s need for a CLIA certificate when performing SARS-CoV-2 surveillance testing using pooled sampling for non-patient-specific reporting: CMS states, “Facilities performing SARS-CoV-2 surveillance testing using a pooled sampling procedure to report non patient-specific SARS-CoV-2 cohort results will not require CLIA certification.”
  2. On a university notifying a specific person that they should seek testing in a CLIA-certified laboratory: CMS clarifies that “If at any time a patient-specific result is reported, the facility is subject to CLIA and required to obtain an appropriate CLIA certificate.” CMS does, however, offer enforcement discretion for SARS-CoV-2 surveillance testing where patient-specific results are reported, provided that the university laboratory does not provide the test result to the patient and refers them to a CLIA-certified laboratory for further diagnostic testing.
  3. How a university laboratory can obtain CLIA certification: CMS outlines resources and methods by which university laboratories can either operate under an existing CLIA certificate of an affiliated university laboratory, or can apply for a CLIA certificate.

Clinical laboratory leaders can view the full text of the CMS Q&As here.

Related Resource:

CLIA and University Laboratory Testing FAQ