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Membership - who do we need input from?

  • Standard Development Organizations

    • Regenstrief

    • SNOMED International

    • HL7

  • Federal agencies

    • FDA

    • CDC

    • NLM

    • NIH

  • Implementers (Labs, also cross-pollinate with implementation subcommittee)

    • Health Partners

    • University of Nebraska

    • Intermountain Healthcare

    • Memorial Sloan Kettering Cancer Center

  • IVD Industry (also cross-pollinate with industry subcommittee)

    • IICC representatives

    • Abbott

    • Biomerieux

    • Roche

  • LIS/LIMS vendors

    • Epic

    • Cerner (reached out)

  • Terminology Services (also cross-pollinate with tooling subcommittee)

    • 3M

    • IMO

    • Clinical Architecture

  • Professional associations

    • Association of Public Health Laboratories (currently maintains the COVID-19 LIVD file)

    • College of Anatomic Pathology (CAP)

  • Others?

Industry Impact

Incentives

Providing review of mappings

Requirements in regulations (for example support for keeping mappings updated to the latest version of the mapped to standards)

Issues

Vendors thought that the FDA would hold them accountable for encouraging “off-label use” based on the interpretation of the LOINC code(s) published

Vendors may want to limit access to their mappings to paying customers only (or at least know who is downloading LIVD files)

Vendors operate internationally, so need to ensure mappings are not just US regulation focused

Standards Development Issues

Ensure the LOINC - SNOMED CT collaborative agreement and how to deal with differences in approaches

Format Considerations

current format is spreadsheet for manual review and use

Ideally we