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2025-12-09 LIDR Meeting Notes
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2025-12-09 LIDR Meeting Notes

Date

Dec 9, 2025

Attendees

Bolded names indicates attendance

 Name

Organization

 Name

Organization

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

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

Andrew Quinn

 

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

 

Marti Velezis

 Sonrisa / FDA

Walter Sujansky

FDA

Susan Downer

JMC

Ralf Herzog

Roche

Cornelia Felder

Roche

Daniel Golson

JMC

Andrea Prada

JMC

Maria Sagat

CAP

Russ Hamm

FDA

Akila Namasivayam

FDA

Desiree Mustaquim - regrets

CDC

Carmen Pugh

long term lab professional

Christina Gallegos

APHL

John Spinosa

Lantana

Matthew Dietz

FDA

Khushi Patel

Deloitte

Sam Wescott

Deloitte?

Li Zha

ADLM

Logistics

Next Steps for LIDR tooling

 

IKE has launched

The tool is open source, so we could use it - it has to be downloaded and locally installed

We could check if the Biomerieux dataset is included and then we could continue the pilot - ACTION ITEM: Riki to email Russ to find out the status (ensure that Biomerieux tests are done only on Biomerieux instruments for optimizing performance, though there is no limit on the culture plates used for growing the isolates, but for the IDs don't mix reagents and systems)

LIDR Patterns

  • Biomerieux culture plates

  • Toxicology screening vs confirmatory

  • challenge tests

  • urine dipstick variations

  • required specimen pre-processing before running on instrument?

Follow up on UDI representation

  • Feedback collected so far:

    • from PH/EPIs is limited so far only 1 response:

      • not looking for it yet, not aware of USCDI; for COVID, since HHS mandate just added a text box to capture device IFDs in their surveillance system

    • Outreach to Surveillance system vendors and cancer registries is limited:

      • Cancer registries are not currently collecting (not a surprise), and are not planning on collecting in the future

    • from discussion in HL7 OO WG:

      • need to support the most granular use case, which is FDA, who wants full UDI

        • adverse event reporting

          • recall vs clinical trial may be different requirements

          • updated notes with clear listing of the use cases

    • From EHRA?

    • From IVD vendors?

    • From middleware vendors?

    • From Labs

      • convo scheduled later this week

      • goal would be to get understanding of what elements are currently trakced (even if not electronically available for sharing)

  • Discussion today:

    • around dealing with UDIs for other aspects of testing:

      • like reagents used for pre-processing of specimen - dilution with saline for example

      • calibrators, QC agents

    • Should only consider devices that can be looked up in the GUUID database

    • If there is no UID, what do we do then?

    • What was the use case for collecting the test kit during COVID?

      • Goal to understand the effect of virus mutation on the targets to evaluate the efficacy of the test over time

  • NEXT STEPS:

    • Invite more stakeholder representatives to the LIDR WG call on Dec 16, 2025

      • Provide brief update on current IHE LAW supports

        • instrument DI and serial number (as PI) should be sufficient

        • INV segment supports testkit / reagent information which covers lot number and expiration date (PI) - may need to figure out the how to get the DI here (local test kit code, which can be looked up in LIVD) - that might allow construction from different sources

      • Provide overview of what is in LIVD

      • Ask for intended use of the information about used devices - what are they looking for, what kind of devices do they want to know about?

        • focus on instrument

        • focus on test kit/reagent vs POC test kit

        • out of scope: disposables, collection devices, calibrators, QC reagents

    • Once we have that, need to review if LIVD spec (Support for GTIN) and IHE-LAW support that for instrument (DI = mandatory is manufacturer, model and and optionally the GTIN and mandatory serial number for the PI in OBX-18) - when this is known a UDI can be created from this - applies at least for instruments

      • need to decide if testkit is needed - how would that be represented in IHE-LAW?

        • in V2 we have PRT segment also, which would have all elements for each device, the PRT segment can repeat

    • If changes are needed to CLSI AUTO 16, need to bring this to Automation and Informatics Expert panel at CLSI (updated version should come out - will have some editoral updates for IHE LAW, too)

    • Once LIVD FHIR IG has been published, need to see, if any changes are needed there with proposed approach

    • How to handle derived observations (e.g. calculated results like eGFR, which is then calculated in LIS, which includes instrument data and data from other sources, like urine volume received as Ask at Collection question with the order / specimen - also depends on what the lab includes in the final reports)

    • Reach out to more IVD vendors to see, if they can produce LIVD files (and/or share mappings), which will help the labs the most

    • presenting on CDC interoperability forum in January to gauge interest with rest of stakeholders - Riki reached out to Jasmine - ANSWER IS YES, date TBD!

Next call

Tuesday Dec 16, 2025 9 - 10 AM ET

Action Item Follow up

Chat

Andrea Pitkus 9:41 AM
https://www.fda.gov/medical-devices/safety-communications/recall-certain-saline-and-sterile-water-medical-products-associated-nurse-assist-fda-safety   Here's an example recall of saline/sterile water.  Unclear if any of these used by any lab nationally.

Riki Merrick 9:49 AM
For the Epis among you,
#1 We would like to know how you are using / would like to use this data?
#2 We want to know what information about devices you will need (we assume you would want to know both if the information is for the instrument or the test kit (or anything else?) as well as one or both of these UDI components: the the device identifier or the production identifier (serial number)?
#3 If you have contacts with disease surveillance system vendors could you either share their info, or ask them the below:
For the disease surveillance system vendors among you we would like to know if you have a preferred format for this, or any limitations that would make you lean one way over another.
For the laboratorians among you we would like to know if you have a preferred format for capturing instruments, test kits (and maybe also calibrators), or any limitations that would make you lean one way over another (fer example workflow considerations).

Action items