The cease-and-desist letters order labs to immediately stop testing. After a lab receives a letter, it is required to provide CMS proof it has stopped testing.
Every facility that conducts COVID-19 testing is considered a laboratory and is required to be certified under the Clinical Laboratory Improvement Amendments of 1988, CMS said. Labs certified as part of the amendments meet federal performance, quality and safety standards to properly diagnose, prevent and treat diseases.
Of the 171 letters CMS sent to labs, 34 percent were facilities that were conducting COVID-19 testing without proper certification, and 66 percent were certified but conducting tests outside the scope of federal standards.
CMS is encouraging labs that aren’t certified to come into compliance so they can resume testing.
It is imperative to public safety that facilities apply for federal 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, CMS said.
Read the agency’s full news release here.
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