As the leading accreditor of laboratories, CAP leaders participated in the April 14 Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting on laboratory regulations during and after the COVID-19 pandemic. Joe Saad, MD, FCAP, who is the Vice-Chair of the Council of Government and Professional Affairs (CGPA), and Christina Wojewoda, MD, FCAP, who is the Chair of the Microbiology Committee, testified before the committee on issues related to laboratory-developed tests (LDTs) and consumer at home tests during the COVID-19 pandemic. The CAP works to ensure regulations protect patients without overburdening pathologists and laboratories, including advocating for a sensible public-private oversight approach and guaranteeing the quality of laboratory-developed tests.

During the meeting, Dr. Saad provided testimony on the quick deployment of the emergency use of laboratory-developed tests (LDTs) during the COVID-19 pandemic. Dr. Saad stated in his submitted testimony that, “The (EUA) process of having uniform standards and guidelines made the ramp-up process more effective, but timely consistent communication from federal agencies is essential. While the Food and Drug Administration (FDA) and the CMS have made recent improvements in this area, initial delays and shortcomings affected the prevalence of testing in the United States.” In light of Dr. Saad’s testimony and discussion, the group recommended creating regionals certified hubs exempt from the Emergency Use Authorization (EUA) process, developing a response network of academic and community laboratories for LDTs.

Dr. Saad also testified on laboratory regulations should include flexibility granted during the public health emergency. “We welcomed the CMS providing flexibility on-site locations, the (remote sign-out) waiver was granted on March 26, 2020 – two weeks after the national emergency declaration – delaying critical testing. Importantly, while we support efforts to streamline administrative procedures for personnel, the CAP strongly believes the current CLIA personnel requirements for testing should be maintained.” The CLIAC committee did discuss on the need for CLIA modernization, which would expand the clinical laboratory response network to pandemics and remote work waivers under CLIA.

Additionally, Dr. Wojewoda provided testimony on Point-of-Care Testing, Self-Collection, and Self-Testing. Because of COVID-19, over-the-counter diagnostic testing increased, the FDA is moving to enable an increased level of at-home diagnostic testing. Dr. Wojewoda, explained the critical performance of these tests are inferior to traditional laboratory testing with the end-user further diminishing the performance of these systems. The CLIAC discussed ways to improve access to US populations, educate end-users on implications of results and limitations of the systems, and determine whether additional regulations are needed.