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Overview

 

Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) is a multi -stakeholder, public-private partnership to improve the quality, utility and portability of electronic laboratory data (i.e., in vitro diagnostic [IVD] data) through the harmonized implementation of semantic data standards that have been appropriately qualified by a sole authoritative source.  Codes for laboratory data should be interoperable: “Describe the same test the same way, every time.”

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By improving the semantic interoperability of laboratory data within and between institutions, diagnostic information can be used to better support clinical decisions and enable Real-World Evidence (RWE) relevance and reliability. SHIELD supports the provision of vetted and harmonized codes from manufactures/industry to laboratories; this enables consistent representation in LIS and downstream to EHR, achieving cross-institutional semantic interoperability.

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SHIELD provides MDEpiNet with harmonized laboratory data coding support for the Learning Communities (LC). LC brings together Coordinated Registry Networks (CRNs) from a variety of clinical spaces. This partnership enables efficient incorporation of laboratory data into CRNs without the need for extensive manual curation. This partnership is funded by the Patient-Centered Outcome Research Trust Fund (PCORTF), Office of the Assistant Secretary for Planning and Evaluation (ASPE)/Health and Human Services (HHS).
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Mission, Goals and Partners

Mission: implementation harmonized application and to advance innovation and reduce burdens to the healthcare.

Goal: Cross Institutional Laboratory Data Interoperability

Develop publicly available infrastructure to improve the quality, interoperability and portability of laboratory data within and between institutions to enable/support of:

  • Clinical Decision Support (CDS)/Artificial Intelligence (AI)

  • Epidemiology/outbreak monitoring

  • Healthcare research and innovation

  • Public health reporting

  • Regulatory decisions

  • Signal detection

  • Real-World Evidence

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SHIELD Stakeholders (>70 institutions engaged):  FDA (CDRH, CDER, CBER), CDC, NIH, ONC, CMS, VA, CAP, IVD Manufacturers, EHR Vendors, Laboratories, Standards Developers, PEW Charitable Trusts, NEST/MDIC, MDEpiNet, Professional organizations, Academia

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By improving the semantic interoperability of laboratory data within and between institutions, diagnostic information can be used to better support clinical decisions and enable Real-World Evidence (RWE) relevance and reliability. SHIELD supports the provision of vetted and harmonized codes from manufactures/industry to laboratories; this enables consistent representation in LIS and downstream to EHR, achieving cross-institutional semantic interoperability.

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Resources

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SARS-CoV-2/COVID-19 Test Coding Resources

Daily COVID-19 test reporting is required by the White House. LOINC and SNOMED-CT are to be used for reporting purposes and are key for advancing RWE utility. For assistance in the assignment of LOINC and SNOMED-CT codes, please refer to the LIVD SARS-CoV-2 Test Catalog at: https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html

For technical support/questions see:

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Medical Device Innovation Consortium

MDIC SHIELD Program

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SHIELD Standards Partners and Associated Efforts

Click here to view table

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Guidance/Recommendations

ONC

FDA

  • 2015 and 2016 SHIELD Multi-Agency Public Workshops

  • FDA Guidance LOINC for IVD Tests

  • FDA Recognition of LOINC and SNOMED-CT

  • FDA RWE Guidance

CDC

 
Support Provided By:

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Contact SHIELD Directly:

Gregory.Pappas@fda.hhs.gov

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