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CMS Releases New Surveyor Guidance Outlining Process of Evaluating SARS-CoV-2 Test Reporting Requirements

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CMS provides guidance for state agency and CMS branch location surveyors to survey CLIA labs’ compliance with COVID-19 test reporting requirements

The US Centers for Medicare and Medicaid Services (CMS) released guidance for surveyors to ensure that CLIA-certified laboratories (those certified under the regulations and standards of the Clinical Laboratory Improvement Amendments of 1988) are in compliance with SARS-CoV-2 test reporting requirements. This guidance went into effect on Jan. 8, 2021, and CMS allowed 30 days for the guidance to be communicated to certification staff.

How CMS Surveyors Will Evaluate Labs’ COVID-19 Testing Reporting

The new guidance (QSO-21-10-CLIA) provides clinical laboratories with insights into how surveyors will focus on COVID-19 testing reporting and how they can avoid citations during surveys. There are 10 probe questions that are suggested for surveyors:

  • Is the laboratory following the manufacturer’s instructions/instructions for use?
  • Does the laboratory hold the correct CLIA certificate appropriate to the assigned authorized setting for the test/test system it is performing/using?
  • Is the laboratory offering SARS-CoV-2 testing under one of the FDA policies, and is the laboratory a CLIA-certified laboratory that meets regulatory requirements to perform high complexity testing?
  • Has the laboratory established performance specifications as required when the FDA has not granted an EUA for a SARS-CoV-2 test, and can the laboratory provide documentation that the performance specifications were reviewed and approved by the laboratory director?
  • Is the laboratory using a secure and traceable system with date and time indications for each activity/access?
  • How does the laboratory’s traceable system ensure only the authorized person can use the electronic signature?
  • Do the laboratory’s policies and procedures include how to report test results?
  • How does the laboratory track SARS-CoV-2 test results that are reported?
  • How does the laboratory document that it has reported SARS-CoV-2 test results?
  • Does the laboratory report results to its state or local health department, or as required by the state?

Clinical laboratory leaders wishing to review this new guidance in its entirety can do so here.

Related Resources:

CMS: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting