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 Collaborative Learning Communities (CLC). CLC 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:

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

  • Epidemiology/outbreak monitoring

  • Healthcare research and innovation

  • Public health reporting

  • Regulatory decisions

  • Signal detection

  • 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 HouseLOINC 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:

Medical Device Innovation Consortium

MDIC SHIELD Program

SHIELD Standards Partners and Associated Efforts

Click here to view table

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:

Contact SHIELD Directly:

SHIELD-LabCodes@fda.hhs.gov 

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