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UPDATE: AACC Actions on COVID-19

By Carmen Wiley, PhD, DABCC, FAACC posted 04-03-2020 14:41

The essential work of clinical laboratory professionals could never be clearer than it is now, as the coronavirus pandemic tightens its grip in the U.S. and in countries worldwide. AACC members have been diligently and determinedly developing, validating, and implementing SARS-CoV-2 tests while also responding to the surge in diagnostic testing from the mounting influx of patients with COVID-19 illness.

Our Policy and External Affairs Core Committee has been working closely with me and the AACC staff to assess this ever-changing situation. We will continue to proactively advocate for you to efficiently develop and perform SARS-CoV-2 tests and to raise public awareness of the need for clinical laboratories to be part of the solution in providing widely available testing. The association has also disseminated educational content and provided resources to the medical community to aid in triaging and testing.

Since my last update on March 5 we have taken these actions:

  • On March 6, AACC warned in a news release that the VALID Act-introduced on March 5 to give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests-would result in decreased patient access to essential medical tests. The association pointed to the delays such a structure caused its members during the coronavirus pandemic and urged Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.
  • On March 9, AACC's Clinical Chemistry Trainee Council presented English and Chinese versions of a Pearl of Laboratory Medicine on COVID-19 and AACC's Learning Lab released a free mini-course on COVID-19.
  • On March 14, AACC issued a press statement and on March 17 a formal news release cautioning that the Families First Coronavirus Response Act as drafted at that time did not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the FDA. AACC asked Congress to correct this oversight.
  • On March 16 I participated along with seven others in a live expert panel convened by Newswise-a scientific information resource for journalists-for 30 reporters covering COVID-19.
  • Since March 16 I have been interviewed about COVID-19 diagnostic testing by many high-level news outlets. From these interviews, AACC and its COVID-19-related resources have been mentioned in at least 21 articles, including in the Washington Post, ABC News, WINK - a CBS local news TV station, Science News, Modern Healthcare, Lab Pulse, 360Dx, Pharmacy Times, Becker's Hospital Review, and the South China Morning Post.
  • On March 18, Clinical Laboratory News published an article relaying the experiences of two clinical labs in bringing up testing even as they faced regulatory hurdles and shortages of test components while the demand for testing escalated.
  • On March 19, AACC launched a directory of U.S. clinical laboratories that are, or will be, performing testing for SARS-CoV-2 to help healthcare providers quickly find laboratories that can diagnose patients suspected of having COVID-19. If you would like to enroll your lab in the directory, sign up here. Labs that need to update their entry in the directory, can do so here.
  • Today, AACC issued a statement commending the U.S. Senate not only for passing the Coronavirus Aid, Relief, and Economic Security (CARES) Act but also for responding to the concerns of the clinical laboratory community and revising this legislation to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether or not they are performed under an FDA EUA. AACC also urged the House of Representatives to move swiftly to pass this bill and send it to the President for his signature.

As efforts keep ramping up nationally and internationally to respond to the pandemic AACC likewise will continue to monitor the situation closely, acting as necessary on behalf of our members and the clinical laboratory profession as a whole.

Our association has been quite proactive in responding to this exceptional public health crisis. I am extremely proud of our efforts to inform the public, policymakers, and the lab community about critical diagnostic testing issues involving COVID-19. The work you, our valued AACC members, and indeed the global lab community are performing inspires me. Together, we are truly making a difference.