SHIELD- Standardization of Lab Data to Enhance Patient-Centered Outcomes Research and Value-Based Care

Improving the Quality, Interoperability and Portability of Laboratory Data within and Between Institutions
Agency
  • Food and Drug Administration (FDA)
Start Date
  • 4/1/2019
Functionality
  • Use of Enhanced Publically-Funded Data Systems for Research
  • Linking of Clinical and Other Data for Research

 

STATUS: Active Project

BACKGROUND

Every day, physicians must make conclusions about a patient’s health status based on a snapshot in time during a brief visit, conversation with the patient, and limited historical (often rhetorical) health information. A simple, and meaningful representation of a patient’s diagnostic history can be invaluable in contextualizing a patient’s personal health care challenges at any single point in time. Laboratory data, however, is commonly excluded from many research efforts due to challenges with data ambiguity. The absence of laboratory semantic interoperability or the ability of two or more systems to exchange, use and analyze information the same way for in vitro diagnostic (IVD) device has been frequently cited as a significant impediment to continuity of patient care, research and overall public healthcare. While it is largely digitized, IVD data that should be represented the same way is often described differently between institutions (or even within an institution) leading to ambiguity and incapacitating its utility in research or other purposes. To address this critical need to improve laboratory data infrastructure, multi-agency sponsored public workshops were held in 2015 and 2016, leading to the formation of the SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) collaborative. The SHIELD collaborative is a multi-agency/stakeholder network consisting of the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Office of the National Coordinator for Health Information Technology (ONC), Centers for Medicare and Medicaid Services (CMS), US Department of Veterans Affairs (VA), IVD manufacturers, EHR vendors, laboratories, College of American Pathologists, standards developers, Pew Charitable Trusts, National Evaluation System for healthcare Technology, and academia.

This project will expand the collaborative efforts of FDA and other stakeholders involved in the SHIELD initiative to ensure laboratory information interoperability, such that the same type of device is described the same way in electronic health records (EHR) systems. To realize this goal, this project will develop code mapping manuals to consistently map the same LOINC (Logical Observations Identifiers Names and Codes) to the same type of IVD. This is important because without the specific guidance, manufacturers of IVD devices and laboratories often assign different (and frequently incorrect) LOINC codes for the same type of device. This project will also pilot implementation of SHIELD standard digital formats to update infrastructure in active healthcare provider laboratories, which will include the seamless distribution of LOINC and SNOMED-CT (Systematized Nomenclature of Medicine--Clinical Terms) coding to those provider institutions and registries.

PROJECT PURPOSE & GOALS

This project aims to improve the quality, interoperability and portability of laboratory data within and between institutions so that diagnostic information can be pulled from different sources or shared between institutions to help illuminate clinical management and understand health outcomes.

The overall objectives of the project are to:

  • Using the process the Regenstrief Institute (owner, developer and curator of LOINC codes) used for Microbiology, develop LOINC code mapping manuals for the remainder of IVD domains: Chemistry, Drug/Toxicology, Allergy, Serology/Hematology, Cell Markers and Molecular Pathology.
  • Conduct pilot implementation and testing of an interoperability upgrade to existing laboratory information systems (LIS) and registries by incorporating SHIELD-approved, high-quality, industry-defined and supported format to facilitate the publication and exchange of LOINC codes for vendor IVD test results.
  • Assess the interoperability and value of the systems and tools tested in the pilot in live LIS and EHR systems pre- and post-implementation.