WASHINGTON—The College of American Pathologists (CAP) urged the Department of Health and Human Services (HHS) to use its authority under today’s national emergency declaration to waive regulatory requirements and give laboratories the flexibility needed to manage the COVID-19 pandemic.
In a letter to Admiral Brett Giroir, MD, the CAP specifically requested a temporary waiver of CLIA requirements and give local laboratories the discretion to work remotely and determine what is best for their staffs to manage the pandemic. Further, the CAP requested the agency postpone inspections of accredited laboratories, which would allow personnel to fully verify and validate new coronavirus testing assays and redesign operations to accommodate emerging technologies and testing.
The March 13 letter to Dr. Giroir was signed by CAP President Patrick Godbey, MD, FCAP, and CAP Council on Accreditation Chair Richard Scanlan, MD, FCAP.
“Pathologists and other licensed healthcare professionals can utilize remote review and sign out for pathology interpretation/diagnosis and other data reviews utilizing virtual private network (VPN) data access,” the letter said. “This would allow laboratories to employ appropriate protocols to reduce the risk of infection among their own teams and to avoid hindering their ability to test and treat patients. If laboratory personnel were to be significantly impaired, it could become difficult for the country to continue to respond to this crisis. Providing this waiver will serve to minimize the disruption to the workforce that is occurring while maintaining the best possible patient care.”
Prior to the national emergency declaration, the CAP remained engaged with officials from the HHS, Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) regarding laboratory testing for the coronavirus disease caused by the SARS-CoV-2 virus. The CAP has provided specific examples of regulatory changes the agencies should make in response to the pandemic. In addition, the CAP has participated in multiple calls to answer questions and request flexibility and discretion on requirements when necessary. The CAP’s advocacy has focused on issues concerning pathologists across the country during the pandemic—namely, the regulatory steps agencies can take to increase laboratory testing and patient access while also maintaining laboratory quality.
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 at cap.org.