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Missteps, strains, shortages: pandemic insights now recommendations

December 2021—In the COVID-19 pandemic and future pandemics, the existing expertise of clinical laboratories should be taken advantage of and labs should be enabled to validate and offer robust clinical assays, say the authors of “The Role of Clinical Laboratories in Emerging Pathogens—Insights from the COVID-19 Pandemic,” published Oct. 29 in JAMA Health Forum (2021;2[10]:​e213154).

Eric Konnick, MD, of the University of Washington, Jordan Laser, MD, of Northwell Health, and Karen Weck, MD, of the University of North Carolina at Chapel Hill, note in their viewpoint the extensive network of clinical labs that routinely develop and implement laboratory-developed testing procedures, regulated under CLIA and administered by the CMS.

“We recommend updating existing CLIA regulations to account for the technological and medical advances that have occurred in the decades since the law was written, rather than imposing duplicative regulatory schemes,” they write. “For example, laboratory classification could be better aligned to reflect the expertise of specific laboratories to guide the types of tests offered, especially in the midst of a pandemic or public health emergency.”

Early engagement of local clinical labs via state health labs and the CDC could enable the expertise and capacity that is available in the U.S. to deploy and scale testing, they say, and they suggest the CDC include additional qualified clinical laboratories in the Laboratory Response Network. They encourage the CDC to “work with professional organizations to develop tools such as assay protocols, testing criteria, control materials, and practice guidelines to enable laboratories to stay at the vanguard of the response.”