2025-07-29 LIDR Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Xavier Gansel

Biomerieux

Pam Banning

3M - Solventum

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 Ott

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 - Deloitte will be at connectathon, but no specific LIDR track planned at this point (Riki to check with Ralf (Roche)), but if FHIR IG not yet published might be too premature)

• LIDR White Paper under SC review- ready to send out the vote

  • OPEN ACTIONS - no update on any of these:

    • Review again for making sure it doesn’t look like LOINC is a bad standard - we don't want to perpetuate inocrrect information - it is not a LOINC issue, it is trying to highlight the issue with modeling lab tests and how folks apply LOINC @Stan Huff

    • 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 @Xavier Gansel - confirmed ok as written and @Ed Heierman

Integrated Knowledge Management (IKM) development

https://www.ikm.dev/

LIDR pilot participation - current focus is on SNOMED CT, still adding in support for LOINC and UCUM etc

Will get update on timeline to support other code systems - actively working on this (RxNorm, GUUID) - waiting for update to schedule next meeting

LIDR

Reviewed the white paper and resolved comments. References still need to be updated.

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

USCDI V6 published

• Includes UDI = https://www.healthit.gov/isp/taxonomy/term/7917/uscdi-v6

• very broad defintion, so might want to support drawing boundaries we need in LIVD and LIDR

  • instrument

  • test-kit

  • exclude supplies

  • What about calibrators?

  • start with DI part of all of these types (then add support in for PI at later time, unless folks support barcode scanning) https://medqair.com/blog/unique-device-identification-udi-system-an-overview/

• 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 and IHE-LAW support that for instrument (DI and PI)

• stakeholder check for what is feasible:

  • LIS/EHR-s vendors

  • IVD vendors

  • middleware vendors

  • Public Health surveillance system vendors

  • Laboratories

  • Public Health

• For HL7 we have a Cross-paradigm IG for all prodcut families to communicate UDI: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=487

• Comment for V7 submission is open till Sep 29, 2025 - have page for feedback set up here: https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/edit-v2/3453616246

• We should review what Connie had proposed a few years ago:

  • Instrument set up is more static (and LAW already sends manufacturer, model = DI), so could include that in the data dictionary, if the LIS cannot get it from the instrument

  • evaluate the workflow changes that might be needed to support

  • who can concatenate the indivdual elements to create the full UDI

• For the SHIELD ADLM presentation we could include UDI requirements to give folks a heads up

• Bring this topic to CDC Lab Interoperabilty Forum (in October or January depending on how fast we get things pulled together?)

• 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

Next Step:

• Re-read Connie’s presentation and understand the pros and cons for each option and apply to complicated scenario to see, if we can better understand workflow impacts

Next call

Tuesday Aug 26, 2025 9:00 - 9:55 AM ET

Adjourned

9:52 AM ET