2025-12-02 LIDR Meeting Notes

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

• Consider connectathon for LIDR

• LIDR White Paper - updated for review to send back to SC

  • resolved all the commentsand will send back to SC

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

Update from IICC meeting:

• Still interested - the initial presentation was in 2023

Overall points to consider:

• need to define the format of UDI we need to capture for LIDR and LIVD and the IVD datahub

  • do we use the full human readable format or do we split it out into the individual parts?

• 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

  • 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

• IVD->Middleware/LIS->EHR->PH systems

• stakeholder check for what is feasible - who is reaching out to whom?

  • IVD vendors - Xavier & Ed = IICC

  • middleware vendors - Pam will try to get some contact

  • LIS/EHR-s vendors - ask Dan & Dr. Agassi - EHRA

  • Laboratories - Matt?

  • Public Health - Riki to ask CSTE / ASTHO

  • Public Health surveillance system vendors - Riki to see, if she can find some contacts

  • Cancer registry software vendors?

• Figure out what the secondary users are looking for - is UDI fit for the intended purpose?

• 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)

• NEXT STEPS:

  • 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

    • Decide on the best format to use for instance data (patient level observations)

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

    • Riki reached out to APHL and CSTE for feedback on what devices for what use and what format feedback so far <ADD LINK>

  • 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 9, 2025 9 - 10 AM ET

Action Item Follow up

• 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