CMS cracks down on labs performing COVID-19 testing without CLIA certification

October 14, 2020

In an effort to protect the integrity of laboratory testing during the COVID-19 pandemic, CMS recently issued 171 cease-and-desist letters to labs who did not have proper CLIA certification in place to perform COVID-19 testing, or were performing testing beyond the scope of their certification.

CMS said since Aug. 12 it has issued the 171 letters to entities that were testing for COVID without the proper CLIA certifications in place. Of the letters, 34 percent went to facilities conducting laboratory testing without a CLIA certificate and 66 percent were issued to laboratories performing COVID-19 testing outside the scope of the existing CLIA certification, according to the release.

The letters ordered these labs to stop testing immediately to avoid inaccurate or unreliable test results. Following receipt of the letter, labs are required to provide CMS an attestation certifying they have ceased testing.

As part of the process, CMS offered provided the non-certified labs with information on how to become CLIA certified and encouraged certified laboratories to obtain the proper CLIA certification to resume testing, the release stated. CMS clarified that any entity performing COVID-19 testing is technically considered a laboratory and must be certified under CLIA.

If your lab was impacted by this enforcement and has questions surrounding how to get properly certified to resume testing, don’t hesitate to reach out to us at 517-486-4262.

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