CMS Issues Guidance Related to New and Modified CLIA Requirements for SARSCoV-2 Test Result Reporting

Published: 01/11/2021

  • Centers for Medicare and Medicaid Services
Relevant To:
  • Clinical Lab

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued guidance for surveyors related to the changes the agency made to Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories requirements in response to the public health emergency (PHE) caused by the SARS-CoV-2 virus.

Section 18115 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act1 requires that “[e]very laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagno

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