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Attendees:

Bolded names were present

Name

Organization

Agenda and Notes

  • Introductions

  • Background – see ppt: <ADD>

    • USCDI V3 is what is the latest adopted version in 2023 – V4 has more lab related data elements, but still missing some like specimen collection date

    • Do not trend results from tests that are not done on the same instrument as the rule, UNLESS you have a harmonization indicator

    • Discussion around proposed LIDR data elements

      •  Specimen as per package insert or the specimen that is used in the lab

        • When specimen are collected by the laboratory the appropriate SCT code is associated with the concept

        • Need to make sure we collect details when we submit the specimen on the patient sample (vs what are the allowable specimen types for an IVD)

        • Also need to ensure we deal with derived specimen (isolates)

    • Some of the elements would be submitted from different sources  - like CLIA numbers would not

    • Should LIDR include all the challenge info or calculated results?

    • How will we prioritize the elements for discussion on calls

  • Committee Priorities Discussion

    • Open Access vs Restricted (not behind a paywall)

      • Some vendors may want to only have customers access to their codes

        • May need to abstract a requirement from this

  • Content vs Infrastructure

    • Should decide on the first set of data elements to be represented in LIDR

    • Identify the data elements needed for the digital fingerprint of a lab test

  • Repository vs Standard

    • LIDR is not a separate data standard, but building on existing ones to transmit the content out of LIDR

    • Repository of information and updates the standards where we need to use them

    • Amalgamation of supported data standards to provide guidance on what to use

    • Identify where these are gaps in existing standards

    • Create a set of user stories we want to cover

    • Should not create a brand new standard

  • Committee Product Discussion

    • Journal Article

    • White Paper

    • CLSI Document

    • Other

    • Originally thought to have a list of requirements

      • What we want in it

      • What we want it to do (like must be free (not pay for access)

      • Create this so that it can be adopted by the community

    • Also need a user manual

    •  What would the journal be used for?

      • Promote adoption of LIDR

      • Helpful to have something that can be cited

  • Collaboration Discussion

    • FDA – Requirements Document (Walter Sujansky, Marti Velezis)

      • For the knowledge management platform

      • Need to get alignment with them.so invite them to a future call

    • Sequoia Project

      • Working on requirements and best practice around laboratory data

  • Open Discussion

    • Exclude LDTs

    • Discuss what lab areas to focus on – set up a priority list

      • Where does blood bank, clinical genomics, etc fits in?

    • We are not doing the mapping, but we need to describe the path we would use to get from the list of requirements and the tool to that actual content creation

      • What if we have panels that include calculations, or what if have the automated instrument that if the result is not achievable, then add in the manual

      • Scope for starters is IVD instrument created

      • Goal should be a minimal viable product

  • For next call:

    • Decide on scope (in or out) and review the existing list of requirements

From Chat: