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To propose steps for creation of LIVD file entries for all IVD tests, available in a centralized repository after mapping review.

Define the initial design and develop a sustainability and steady state plan for use of LIVD specifically and for other SHIELD standards in the future

Items in scope:

• Current:

  • Produce a white paper that is citable with the requirements

  • Gather requirements for a LIVD file repository and develop related budget item for development

  • Develop a plan for steady state

    • operationally

      • Develop process to add new data elements

      • Develop process for feedback on content

    • financially

      • find a sustainable solution that retains free access to the data in LIDR

  • Develop and recommend a LIVD planning strategic plan

    • Creation of LIVD Catalog by IVD Manufacturers - increase number of manufacturers creating catalog (Ed H.)

    • LAW adoption - increase number of instruments supporting IHE LAW (Ed H.)

    • Alignment of LAW/LIVD with Hospital System protocols (Ed H.)

  • Identify mapping content applicable to a LIVD catalog for terminology alignment (Ed H.)

    • Identifier of Test Performed (LOINC)

    • Type of Specimen (SNOMED CT)

    • Type of Qualitative Result (SNOMED CT)

    • Units for Quantitative results (UCUM)

    • Type of Equipment Identifier (UDI or other means to uniquely identify the kit - e.g. for LDTs)

    • Type of Test Kit Identifier (UDI or other means to uniquely identify the instrument used - e.g. for LDTs - but less likely)

    • Type of method used (SNOMED CT) - may help with automating LOINC assignment

    • LAW coverage of terminology

• Future:

  • Develop LIVD planning roadmap of supporting activities

Items out of scope:

• Harmonization of lab tests - this is important work for clinical interoperability, but is not terminology related, requires lab studies etc

Prior work:

https://aphlinformatics.atlassian.net/wiki/spaces/SLC