In the rapidly evolving landscape for diagnostic testing for the SARS-CoV-2 virus, the CAP can help clarify and simplify the rules of compliance so that you can efficiently and safely introduce testing in your laboratory to serve your patients during this public health emergency. A brief definition of key regulatory terms will set the stage for a deep dive into the requirements for implementing and running SARS-CoV-2 testing in your laboratory. We’ll cover what’s required for verification and validation when bringing up a new test plus ongoing requirements for personnel and quality monitoring to keep the test running. We’ll even discuss what to do when your best laid plans go awry, and you need to change course because your critical supplies are now out of stock.
Richard Scanlan, MD, FCAP