Systemic Harmonization and Interoperability Enhancement for Lab Data (SHIELD)

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 contact:

Test manufacturers and developers: SHIELD-LabCodes@fda.hhs.gov.
Test users (e.g., laboratories/healthcare providers): dlsinquiries@cdc.gov.

SHIELD Overview

Describing the same test the same way

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 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