CMS orders halt in non-CLIA-certified labs’ COVID-19 testing

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CMS orders halt in non-CLIA-certified labs’ COVID-19 testing
tjordan_drupal
Oct 12, 2020

The Centers for Medicare & Medicaid Services Oct. 9 announced a crackdown on labs that are testing for COVID-19 without proper Clinical Laboratory Improvement Amendments certification.

The agency said it has issued 171 cease-and-desist orders to facilities that were either conducting lab testing without CLIA certificates or performing COVID-19 testing outside the scope of existing CLIA certifications. The letters include information for non-certified labs on the CLIA certification process; the CLIA review process was recently streamlined by CMS.

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CMS orders halt in non-CLIA-certified labs’ COVID-19 testing
tjordan_drupal
Oct 12, 2020

The Centers for Medicare & Medicaid Services Oct. 9 announced a crackdown on labs that are testing for COVID-19 without proper Clinical Laboratory Improvement Amendments certification.

The agency said it has issued 171 cease-and-desist orders to facilities that were either conducting lab testing without CLIA certificates or performing COVID-19 testing outside the scope of existing CLIA certifications. The letters include information for non-certified labs on the CLIA certification process; the CLIA review process was recently streamlined by CMS.

Novel Coronavirus (COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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