2025-11-04 LIDR Meeting Notes

2025-11-04 LIDR Meeting Notes

Date

Nov 4, 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?

Logistics

  • Consider connectathon for LIDR

  • LIDR White Paper - need to review comments and decide what to send back to the SC

    • OPEN ACTIONS - no update on any of these:

      • Review Figure 6 and associated text against Figure 8 and associtated text and combine / adjust as needed @riki.merrick

      • Add in Reference to AUTO 16 and provide the mapping between LIDR entries and instance data @riki.merrick

      • Review the LIVD/LIDR requirements section to ensure we have the proper vendor view - confirmed ok as written by both Xavier and Ed

  • Will see, if we can just get this published as is - Hung will clean up the White Paper references and then we will send it back to the SC for vote

  • Hung will draft a first manuscript based on the LIDR White Paper

Next Steps for LIDR tooling

 

IKE has launched

The tool is open source, so we could use it

We could check if the Biomerieux dataset is included and then we could continue the pilot

LIDR Patterns

  • eGFR - calculated based on values produced by instruments and patient demographics; but knowing which formula is being used - it does affect the selection of the LOINC (though not the patient’s sex)

    • Patient demographics comes across separately with the patient

    • We are trusting the lab to select the correct reference range for all results

    • eGFR Equations for Adults - NIDDK - this seems the formula differs based on the value of the Serum Creatinine

      • some labs do set up the testing for males vs females

      • we did mention that input for calculation values should be included with the results, so then you can understand

    • Do we need to include formula information in the LIDR file?

    • Question was are the vendors changing over to the new reagents? - How can we know?

    • LIDR WG will need to develop the content for calculations

  • High Sensitivity Troponin

LIDR provides the information about the kind of tests perfromed, when you do analytics / decision support on instnace data from that kind of test, if there are additional attributes, like patient demographics or serum levels or anything else in the instance record that needs to be taken into account at time of implementation is OUTSIDE of LIDR, but absolutely important - need to think whetehr this is something we need to communicate and if we decide we do, figure out how

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 in November

      • Riki reached out to APHL and CSTE for feedback on what devices for what use and what format, waiting for feedback

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

Next call

Tuesday Nov 11, 2025 9 - 10 AM ET

Cancel 11/18 due to AMIA and 11/25 due to Thanksgiving

Reviewing minutes from the last call - Action Item Follow up

Chat

 Andrea Pitkus 9:14 AM (Edited)
Was there an agenda today?  Shall we discuss some LIDR patterns?  Curious about representing hs Troponins and eGFRs

Andrea Pitkus 9:17 AM
It is a holiday for federal folks, but it varies amongst others

Andrea Pitkus 9:25 AM
eGFR Equations for Adults - NIDDK

Action items