WASHINGTON – A new paper utilizing survey data from the College of the American Pathologists (CAP) highlighted the importance of laboratory supply chains and personnel to meet testing demand during the COVID-19 pandemic.
The article, “Pandemic Demand for SARS-CoV-2 Testing Has Led to Critical Supply and Workforce Shortages in US Clinical and Public Health Laboratories,” was published in the Journal of Clinical Microbiology and available online in July 2023. The lead author of the article is Nancy E. Cornish, MD, a Centers for Disease Control and Prevention (CDC) medical officer who works in its Division of Laboratory Systems, Center for Surveillance, Epidemiology, and Laboratory Systems.
“All the surveys revealed that supply shortages resulted in reduced capacity of laboratories to provide tests for SARS-CoV-2 and adversely impacted routine microbiology molecular tests and culture requests such as blood cultures and other cultures,” the authors said. “In addition, the full impact of the shortages was not realized until the U.S. shutdown was lifted, elective medical and hospital procedures and clinic visits resumed, and routine laboratory test requests increased.”
Through a series of surveys of pathologists and laboratories, the CAP captured hard data showing the substantial burdens supply shortages has had on the laboratories performing testing for the coronavirus disease. The CAP has shared the data with members of Congress, the administration, and other policymakers working to mitigate the pandemic and solve persistent laboratory supply chain issues. Previously, Joe Saad, MD, FCAP, who is a member of the CAP Board of Governors and Vice Chair of the Council on Government and Professional Affairs, presented the CAP’s survey data to the CDC’s OneLab training group.
For example, in one 2021 survey about 45 percent of laboratory directors said that it was difficult or very difficult over the prior three months to acquire reagents for platforms/test kits, and 30 percent reported difficulties in acquiring pipette tips for COVID-19 testing.
In addition to the CAP, other organizations contributing data included the American Society for Microbiology, the CDC Division of Sexually Transmitted Disease Prevention, and the Emerging Infectious Disease Network.
To address supply shortages, the CAP supported the PREVENT Pandemics Act that Congress passed in 2022. Provisions in the bill seek to strengthen supply chains by, among other things, requiring the government to issue guidance on how states can access the strategic national stockpile (SNS) and sharing information about the maintenance and use of the SNS and future procurement plans. The law also authorized the Department of Health and Human Services (HHS) to contract with public and private entities to increase capacity for the rapid development, validation, manufacture, and distribution of diagnostic tests for immediate public health response activities to address an emerging infectious diseases.
The CAP is also following several provisions in the Pandemic and All-Hazards Preparedness Act reauthorization legislation that is currently being debated in Congress. This includes legislative language to authorize certain contracts and cooperative agreements with clinical laboratories for purposes of delivery of medical products to the SNS and requiring a diagnostic testing preparedness plan to be used during public health emergencies.
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About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. As a 501(c)(6) membership organization, the CAP is the only entity representing pathologists with unrestricted advocacy capability and a political action committee, PathPAC. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. Read the CAP Annual Report.