Compliance Concerns for Respiratory and Clinical Labs Performing COVID-19 Testing

 

The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the significant increase in lab tests brought about by widespread testing for COVID-19. For example, in March 2021, labs had processed more than 363 million COVID tests, which averages out to about 1.1 tests per U.S. citizen. This number is rapidly growing as, each day, labs process more than one million COVID tests.

That said, initially, COVID testing got off to a slow start. The result was that the federal government did little to regulate respiratory and clinical labs in the processing of samples for fear of standing in the way of getting the disease under control. However, now that a vaccine is available, much of the country is vaccinated, and the disease (at least temporarily) appears to be under control, the federal government is cracking down on respiratory and clinical labs performing COVID-19 testing.

By some estimates, upwards of 80% of all COVID tests are processed by private labs. Clinical labs face complex regulatory requirements when ensuring they comply with current federal laws, especially in the wake of the pandemic. Thus, it is essential that respiratory and clinical labs performing COVID testing ensure that their procedures and policies are compliant with the current regulatory framework.

For more information visit here https://www.jdsupra.com/legalnews/compliance-concerns-for-respiratory-and-4460313/