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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:

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

  • Develop a plan for steady state

  • 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

Hung Luu

UT Southwestern Medical Center

Working Group Co-Chair; SC liasion

Riki Merrick

Association of Public Health Laboratories

Working Group Co-Chair; SC liasion

Andrea Pitkus

University of Wisconsin-Madison

Steering Committee member

Xavier Gansel

Biomerieux

Steering Committee member

Rob Rae

CAP

Dan Rutz

Epic

Steering Committee member

Pam Banning

3M Health Information Systems

Laurent LARDIN

Biomerieux

Amy McCormick

Epic

Sandy Jones

CDC Cancer Surveillance

Stan Huff

Graphite

Steering Committee member

Craig Collom

Steering Committee member