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Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD)

Illustration of a piece of clinical laboratory equipment, under the word SHIELD, which stands for Systemic Harmonization and Interoperability Enhancement for Laboratory Data.

Since 2015, the FDA has partnered with federal agencies and key stakeholders from 70+ organizations (including federal, academia, and industry) to form and grow the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) collaboration. SHIELD aims to bring together the brightest minds from across the laboratory data ecosystem to build, implement, and support a comprehensive solution that addresses clinical and semantic device interoperability of in vitro diagnostics (IVD) across the nation. This encompasses data as it flows throughout the entire laboratory data life cycle (that is, the exchange of data from standards organizations to IVD devices to laboratory workstations to Electronic Health Records [EHR]).

In 2023, key stakeholders established the SHIELD Collaborative Community. Members of the FDA SHIELD program team participate in this collaborative community.

Through the innovative harmonization of data standards such as SNOMED-CT (a U.S. government system used for the exchange of electronic clinical information) and LOINC (a database and universal standard for identifying medical laboratory observations), the FDA SHIELD program team is working to develop a platform that dramatically improves the quality and portability of laboratory data, which helps reduce patient safety risk. This work will be done in cooperation with leading laboratory data experts across the nation, prioritizing knowledge management, systems thinking, enhanced analytic data storage, and ecosystem engagement.

Infographic showing SHIELD Priority Areas

Challenges with Data Collection and Analysis

Clinical laboratory data – orders, results, and interpretations – are among the most important types of data for clinical care, public health, and the development of medical devices. Because of its widespread use, laboratory data has the potential to move freely between different systems.

Infographic showing the expectation that SHIELD will result in an ideal of single-trip laboratory data integrity of 100% and the factors that contribute to that expectation.

Unfortunately, laboratory data is simple to transmit, but tremendously challenging to manage and evaluate due to non-standardized encoding practices used by IVD manufacturers, laboratories, and EHR vendors nationwide. This diversity in IVD test data may have an impact on patient safety and make it more difficult to analyze lab data on a national level.

Researchers conducted an evaluation with five health care systems that found data maintained only 59% integrity as it moved from laboratory analyzer to laboratory information system. Similarly, the authors of a Journal of the American Medical Informatics Association (JAMIA) article estimated that the integrity of a single round-trip through the lab data lifecycle yielded 22-68% integrity.

Infographic showing the reality of single-trip laboratory data integrity of 22-68% and the factors that contribute to that reality.

Though testing methods and devices across laboratories throughout the country remain consistent, there are significant challenges that impede data collection and analysis and could adversely impact patients, providers, and organizations.

  • There is no systematic application of codes by device manufacturers and data standards are not harmonized.
    Impact: significant variation in organization, categorization, and storing of results
  • Existing standard interface specifications between IVDs and LISs are not implemented consistently across systems
    Impact: there is room for manual translation and user-error
  • There is no hierarchy of concepts in the primary laboratory data standard
    Impact: multiple available codes with varying levels of granularity for the same test
  • Not all relevant and pertinent data elements are codified or even included in the current interface implementations
    Impact: valuable, useful information is not captured or codified

Example of Challenges

SHIELD Funded Program Portfolio

Contact Us

For additional information, contact SHIELD-LabCodes@fda.hhs.gov.

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