The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulate laboratory testing. CLIA requires that clinical laboratories are certified by the Centers for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
Generally, CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.
Before conducting any clinical diagnostic or serological SARS-CoV-2 testing, a laboratory must be CLIA-certified and meet the applicable regulatory requirements.
The lab’s CLIA certification must correspond to the highest level of complexity of tests performed. The more complicated the test, the more stringent the specific CLIA quality standards and requirements are for personnel qualifications and responsibilities.
