2025-09-23 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 waiting for SC vote

  • 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

Reviewed comments received

Next Steps for LIDR tooling

Integrated Knowledge Management (IKM) development

Riki to email Russ to get link to tool on GitHub (KOMET) = Integrated Knowledge Exchange (IKE) launch

Bringing Integrated Knowledge Management to Life | Integrated Knowledge Management

LIDR pilot participation - current focus is on SNOMED CT and LOINC

Follow up on UDI representation

IICC presentation of UDI representations for CDC Interoperability Forum on Lab Standards Group - discuss with Connie (update this maybe?

Aim for January call as this is a good venue to engage federal folks to give them better understanding of the issues

IICC meeting next month, Ed will bring this up

would be good to have discussion on what are preferred approaches for instruments and LIS

SHIELD Update slides got accepted for AIMIA - might be good to understand how UDI will be represented in all information systems engaged in lab data exchange - how will it be sent and how it can be represented in the analyzer managger / LIS etc

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 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

• 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

Email from Scott

Example HL7 V2 ZS1 segments containing the staining used for the slide including reagents (with lot numbers) used in the stain - thoughts on how to translate that for LIVD / LIDR?

Open

Took a brief look at this screenshot as part of the feedback on USCDI V7

Prepping for SC call related to UDI https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/edit-v2/3453616246

• Created the draft verbiage for UDI and Specimen Condition Acceptability

• Note that Epic is currently creating profiles for different tests at different granularities:

  • example lead testing:

    • one axis is specimen type (venous vs capillary blood)

    • another axis is the POCT instrument

• Need to provide guidance on how to understand the implementation implications for each of the USCDI elements - SHIELD would be a good community to provide that input - getting this input the

• DOES THIS WORK?

Call Adjourned

10:01 AM ET

Next call

Tuesday Oct 14, 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