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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)

  • Like to see that data instances of test data is being collected for regulatory use – so FDA would need to share the requirements

  • Industry is being asked by customers to provide LOINC mapping (not so much SNOMED codes yet) because there is a requirement for reporting to PH as well as for MU to have the tests be represented using LOINC

  • ONC should clearly state that LOINC mapping is still required and needs to be maintained

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

  • Future formats should

    • support automatic mapping, if possible

    • support mapping assistance for manual selection

    • be more easily searchable