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 - regrets

Graphite

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

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 and they are working through feedback

  • 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 @Russell Ott (Unlicensed) shared this file <ADD HERE!>

    • Review the LIVD/LIDR requirements section to ensure we have the proper vendor view @Xavier Gansel and @Ed Heierman

Integrated Knowledge Management (IKM) development

Bringing Integrated Knowledge Management to Life | Integrated Knowledge Management

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)

LIDR Googlesheet Potassium and more LIVD data

READ ME tab discussion:

• Need to make clear that DTC definition here is the FDA designation in package insert, NOT the jurisdiction

  • DAT: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/directaccesstestingpdf.pdf

  • DTC: https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests#:~:text=Direct%2Dto%2Dconsumer%20tests%20have,get%20a%20disease%20or%20condition.

  • OTC: https://www.fda.gov/medical-devices/diagnostic-data-program/digital-diagnostics-over-counter-otc-and-point-care-poc#:~:text=Over%20the%20past%20several%20years,for%20conditions%20beyond%20infectious%20disease.

• Difference to OTC defintion - OTC is for testing by non-lab professional, while for DTC the testing is performed at a lab, may be collected by consumer, not need a prescription?

  • Need to better understand what prescription here means - assume order by provider needed

• We will need to revisit which one(s) of these we feel should be in scope for LIDR

ProBNP tab discussion:

• used this test for building this out in IKM - rows 2, 5, 8 come from the Biomerieux file

• differecnce between entries in rows 2 and 5 is the differnt packaging (referneceID) and related UDI

• Ser/Plas vs using only Ser or Pl when the lab creates this in their compendium - linking the acellular blood LOINCs to the more specific specimen requriements for each lab - that’s why there are additional rows

• have now added LOINC and LOINC ontology in the IKM; will have this - will provide update on what can be shared on next call

• can now do distributed authoring rather than creating duplicate records for truely duplicate content, but overlay localizations

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

Next call

Tuesday Jun 10, 2025 9:00 - 9:55 AM ET

Adjourned

9:47 AM ET