Brainstorming Notes

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