Since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without the appropriate certifications under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA, which verifies that labs meet federal performance and quality standards to help ensure they provide reliable results.
According to CMS, 34% of the labs that were ordered to stop testing were operating without a CLIA certificate, while the remaining 66% were performing COVID-19 testing outside the scope of their existing CLIA certification. The letters provided non-certified labs with information on how to become CLIA certified and encouraged certified labs to obtain proper CLIA certification so they could resume COVID-19 testing.
Source: CMS Takes Action to Protect Integrity of COVID-19 Testing