The College of American Pathologists (CAP) President Patrick Godbey, MD, FCAP issued a statement opposing the latest interim rule on COVID-19 laboratory reporting.
“The CAP strongly opposes the new penalties that the Department of Health and Human Services (HHS) will impose on laboratories who do not meet the COVID-19 data reporting requirements. Despite the CAP’s repeated requests with the department to clarify and specify the reporting requirements, and provide a workable timeframe for implementation, the requirements remain unclear and unworkable for many laboratories.
The CAP calls on HHS to rescind the new requirements, the threats of penalties, and reissue a final laboratory data reporting regulation that is more clear. Imposing penalties when laboratory data requirements are ambiguous and impractical have greatly alarmed the laboratory medical community.
As previously stated in prior meetings with HHS officials, the agency needs to rescind the laboratory data reporting requirements and provide a flexible, phased-in approach to implement a complex reporting system. The HHS is still failing to recognize that this country's data infrastructure is not ready for such requirements.
The CAP is disappointed that the regulation waives standard provisions in rule making, such as the 30-day delay in the effective date. Moreover, the CAP is frustrated that the government is establishing these policies as applicable on the date this regulation is published.”
