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.”
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.

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).

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:
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Clinical Decision Support (CDS)/Artificial Intelligence (AI)
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Epidemiology/outbreak monitoring
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Healthcare research and innovation
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Public health reporting
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Regulatory decisions
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Signal detection
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Real-World Evidence
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
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.

Resources
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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Test manufacturers and developers: SHIELD-LabCodes@fda.hhs.gov
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Test users (e.g., laboratories/healthcare providers): dlsinquiries@cdc.gov
Medical Device Innovation Consortium
SHIELD Standards Partners and Associated Efforts
Guidance/Recommendations
ONC
FDA
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2015 and 2016 SHIELD Multi-Agency Public Workshops
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see: recordings, transcripts, and a discussion paper
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FDA Guidance LOINC for IVD Tests
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FDA Recognition of LOINC and SNOMED-CT
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FDA RWE Guidance
CDC
Support Provided By:
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Presidential Advisory Council for Combatting Antimicrobial Resistant Bacteria (PACCARB)
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Dedicated volunteers who have invested countless hours and expertise
Contact SHIELD Directly: