2025-10-14 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

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

Next Steps for LIDR tooling

Integrated Knowledge Management (IKE) development

Riki to email Russ to get link to tool on GitHub (KOMET) = Integrated Knowledge Exchange (IKE) launch - email was sent 10/9 and again today - this link was shared on the IKE Community Launch event: https://github.com/ikmdev/komet

https://www.ikm.dev/

Community Launch event Oct 15, 20252 - 4 PM EDT - Microsoft Teams Need help?

Join the meeting now

IKE Community web page: https://www.ikehub.org/ and zulip chat: https://ike.zulipchat.com/

Recording of the event

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

    • we will bring this up on the ADLM webinar Oct 22, 2025 12 - 1 PM EDT - and the registration link: https://artery.myadlm.org/discussion/dsi-webinar-event-oct-22#bm3122bfd4-8db2-4e2f-8928-66dbda011d12

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

    • invite more stakeholder representatives to the LIDR WG call in November

  • presenting on CDC interoperability forum in January to gauge interest with rest of stakeholders

Next call

Tuesday Oct 28, 2025 9 - 10 AM ET

Reviewing minutes from the last call - 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