Page Comparison

To propose steps for creation of LIVD file entries for all IVD tests, available in a centralized repository after with or without 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

Ultimate goal is to have data used in patient care, research public health be comparable - need to have support for the full data model for the complete meaning of the test

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 and review new data elements

      • Develop process for submission, optional review and feedback on content

      • Should include a QA process as part of the submission for either new data elements as well as content

    • financially

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

  • Develop and recommend a LIVD planning strategic SHIELD endorsed standards implementation plan

    • Creation of LIVD Catalog by IVD Manufacturers - increase number of manufacturers creating catalog

    • LAW adoption - increase number of instruments supporting IHE LAWAlignment of LAW/LIVD with Hospital System protocols

    • Get more of the standards used in SHIELD as part of Recognized Consensus Standards: Medical Devices (fda.gov)

      • currently listed: LOINC, SNOMED, POCT1A

      • missing: UCUM, CLSI AUTO16 / LAW, IHE profiles

  • Identify mapping content applicable to a LIVD catalog for terminology alignment

    Identifier of Test Performed (

    (this WG definds the elements, the Vocab and Standards identifies the best approach)

    • Alignment of data elements supported in LIDR / LIVD with those already supported in LAW

    • Alignment of data elements in LIDR / LIVD needing support in LIS and EHR Systems

  • Identify which of the data elements are needed in the data flow and which are needed for reference within LIDR

    • evaluation against pre-analytical / analytical and post-analytical workflows

• Future:

  • Develop LIVD planning roadmap of supporting activities

  • Provide guidance on best terminology representation for specific methods (TBD in which committee)

Items out of scope:

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

• Information modeling around how data from different tests are put to use in LIS / EHR-s data exchange

Workplan

• Identify the elements for the MVP

  • what each use case needs

  • if elements are just in LIDR, or need to move with patient data

  • As part of MVP at minimum:

    • Name of ordered test (and identifier LOINC)

    • Name of test performed test (and identifier 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