Laboratory Data Standards for Interoperability

In response to a requirement in the Consolidated Appropriations Act, 2023, the ASTP/ONC prepared a report on the use of data standards for laboratory data exchange. The report explores data standards adoption and impact at each step of the laboratory workflow, from ordering through sharing the results with patients, providers, public health agencies, and more. This report is grounded in independent research, consultation with subject matter experts, and interviews and input from across the laboratory ecosystem. Additionally, ASTP/ONC lays out areas for improvement and a future vision to further enhance interoperability and exchange of laboratory data.

Laboratory information is critical to medical care, public health, and clinical research, and virtually every person who has received medical care has experienced some type of laboratory testing. The timely and precise reporting of laboratory testing results reduces the risk of diagnostic error and enhances the overall quality of care. Laboratory testing results are often the primary signal shared with public health agencies to alert them to potential public health events, and laboratory data are a critical component of real-world data used to improve healthcare practices. Despite progress in recent years, clinical laboratories still face obstacles with widespread adoption and consistent implementation of data standards. These standards create a shared understanding of data across systems, which is foundational for access to laboratory data.

Improving laboratory data interoperability is a complex task, requiring a multi-faceted approach and years of incremental improvements. The ASTP/ONC report highlights several challenges across the laboratory ecosystem, such as a lack of incentives to do resource-heavy upgrades, habitual use of local or custom codes, delays in updating of terminology and exchange standards, and insufficient training and support. ASTP/ONC explores actionable solutions to address these issues, including incentivizing and requiring laboratories to conform to common standards, conditioning the receipt of federal funding on the use of certified health IT, modernizing public health laboratory technologies, and promoting participation in the Trusted Exchange Framework and Common Agreement™ (TEFCA™). With these actions, laboratory interoperability can become less burdensome and more efficient, and can help patients, clinicians, and researchers receive timely access to information that can improve the quality of care.