NORTHFIELD, Ill.–The US Food and Drug Administration (FDA) is extending a $1 million one-year contract awarded to a multidisciplinary CAP team in 2022 by an additional year and for an additional $2.5 million through September 2024.
This contract will allow the CAP to further develop and improve laboratory test coding standardization and usability to improve public health and patient care.
“We are making great progress on objectives for the current phase of the FDA contract producing a strategic design for encoded laboratory test result data flow, validation, and interoperability,” stated M.E. (Doc) de Baca, MD, FCAP, chair of the College of American Pathologists’ Council on Informatics and Pathology Innovation. “We have met our set deliverables for the FDA interim milestones, putting ourselves in a good position to hit the ground running this fall for the extension.”
The FDA contract extension aligns with the CAP’s proposal to deliver three primary objectives building on the current strategic design work in progress:
- Laboratory Coding Transmission Feasibility POC: Perform a proof of concept (POC) with a laboratory to understand if the encoded data coming back to the CAP has the appropriate mapping to the Laboratory Interoperability Data Repository (LIDR) standard, under development as part of the government supported SHIELD initiative. Examine the quality of the data coming back and address any gaps. Perform analysis to determine if the encoded test data coming back would meet the necessary threshold for different data transmission standards.
- Test Menu Coding Education & Training POC: The CAP will provide training, education, and the necessary tools to educate laboratories on system changes that will need to be performed to implement LIDR and will provide training and education on any system changes needed to accommodate interface or interoperability requirements.
- Proof of concept with Analysis Normal form (ANF): This is to demonstrate if and how laboratory data with LIDR could be formulated into meaningful structured and interoperable clinical statements.
“This is a testament to the hard work and dedication of our CAP team to deliver outstanding results at the highest standard of excellence,” said Dr. de Baca.
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. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.
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