2023-07-24 Meeting Notes

Attendees:

Bolded names were present

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) - we have a space on our main page (https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/1938718763/Laboratory+Interoperability+Data+Repository+LIDR+Working+Group#Scope ) and review the existing list of requirements = LIVD File Repository Requirements

From Chat: