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Attendees:

Bolded names were present

Name

Organization

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Sandy Jones

CDC

Stan Huff

Graphite

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Agenda and Notes

  • Introductions

  • Background – see ppt: <ADD>

    View file
    nameSHIELD Community LIDR Committee.pptx

    • 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:

From Chat:

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