2026-02-03 LIDR Meeting Notes

Hung Luu - regrets

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

University of Wisconsin

Pam Banning

3M - Solventum

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Stan Huff

University of Utah

Ed Heierman

Abbott / IICC

Carmen Pugh

long term lab professional

Laurent Lardin

Biomerieux

Ralf Herzog

Roche

Christina Gallegos

APHL

Follow up on UDI representation

Adding Conclusion here: UDI Background

Will keep filling this page out to collect all solutions there.

UDI presentation to CDC' Forum on Adoption of Standards for Laboratory Data on Mar 3, 202612 - 1 PM ET

Open

Discussion today:

Ensure we talk about reagents in addition to instruments

Give more of a background - actual examples of real world problems (Flu test was giving false positives for Flu B (Carmen to check if she can get the details)

include the fact that labs have to trace this for CLIA (and FDA could request for adverse event follow up), but not currently sharing with results in real time - what is the current system not addressing

Uses this meeting as introduction with commitment of follow up for specific details

email comments to Ed and Riki

IKE Community meeting last week: https://www.youtube.com/watch?v=jqbDwXQThJE

presented KOMET and the device-extension, includes the UDI from GUUID, but may need to have some more explanation on what is the instrument and reagent/testkit

SHIELD and LIDR were mentioned quite often

FDA didn’t seem to have been officially participating in the call

USCDI V7 Draft was published

core-data-interoperability-uscdi#draft-uscdi-v7

Comments due Apr 13, 2026

Laboratory Class

(no specimen collection date/time - specifically, but covered in examples in Performance Time under the more general Healthcare Attributes, but collection method was added)

Healthcare Information Attributes - broader than lab

covers new: Diagnostic Report Date and Reason Not Performed

Medical Devices Class

• added device type - pointing to SNOMED CT (no hierarchy listed, but potentially use descendenants of 272181003 |Clinical equipment and/or device (physical object); FHIR US Core uses https://hl7.org/fhir/R4/valueset-device-kind.html ) and provided some clarifying text in the class

  • GMDN will be included in SNOMED CT going forward, probably as its own extension:

    • https://www.snomed.org/news/gmdn-agency-and-snomed-international-announce-strategic-collaboration-to-advance-global-medical-device-content-and-interoperability

    • https://www.gmdnagency.org/gudid-d https://www.gmdnagency.org/gudid-database-updated-to-include-gmdn-code/

  • Reagents might be considered substances from a SNOMED CT hierarchy perspective

  • Consider including this as part of LIDR to support mapping

LIDR Patterns - not discussed

• Biomerieux culture plates

• Toxicology screening vs confirmatory

• challenge tests

• urine dipstick variations

• required specimen pre-processing before running on instrument?

Action Item Follow up - Not discussed

• State of LIDR tooling: Some of the Biomerieux content is in KOMET which is now referred to as the device extension (DeX) = LIDR (is in GitHub here: https://github.com/ikmdev/komet) - there will be another IKE community meeting

  • Date: Thursday, January 29th
    Time: 2:00-4:00 PM EST
    Location: Virtual
    Register here for the meeting link

• Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary

  • Review operational definition of “equivalence”

    • Will look for a CLSI defintion

    • also check IFCC definition

• Outreach to Dr. DeBaca

  • Hung will check for more info and maybe see, if she could participate in SHIELD

• Keep updating the googlesheet: Potassium LIVD data

• Shared Reportable Conditions LIVD google sheet for crowdsourcing with CSTE - added sign up sheet for PHAs to specific conditions and see how that develops

• Have LIVD File Repository Requirements

  Have draft budget (for setting up a web-based database and yearly maintenance): https://aphlinformatics.atlassian.net/wiki/download/attachments/915407143/LIDR - Budget.xlsx?api=v2

• Define next steps to migrate existing LIVD files into FHIR LIVD catalog format and find a FHIR server to host

Next call

Tuesday Feb 10, 2026 9 - 10 AM ET