October 13, 2020 – The Centers for Medicare & Medicaid Services (CMS) announced that since August 12, it has issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without an appropriate CLIA certificate.
CLIA certification is important because it verifies that laboratories meet federal performance, quality and safety standards to properly diagnose, prevent and treat diseases, CMS said.
Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA. To make certification easy, CMS implemented an expedited review process at the beginning of the public health emergency and recently released a quick-start guide that helps laboratories with the application process.
“It is imperative to public safety that facilities apply for CLIA certification and only operate within the scope of that certification to prevent false results that could adversely alter diagnosis, treatments and contribute to the further spread of COVID-19,” the agency said in a press release.
Of the 171 letters, 34% went to facilities conducting laboratory testing without a CLIA certificate and 66% were issued to laboratories performing COVID-19 testing outside the scope of the existing CLIA certification. The letters ordered these laboratories to stop immediately to safeguard the integrity of COVID-19 testing, and protect patients from potential endangerment if provided inaccurate or unreliable test results. Following receipt of the letter, laboratories are required to provide CMS an attestation certifying they have ceased testing.