2026-02-17 LIDR Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

University of Wisconsin

Pam Banning

3M - Solventum

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Stan Huff - regrets

University of Utah

Ed Heierman

Abbott / IICC

Carmen Pugh

long term lab professional

Laurent Lardin

Biomerieux

Ralf Herzog

Roche

Christina Gallegos

APHL

Follow up on UDI representation

Adding Conclusion here:

Will keep filling this page out to collect all solutions there.

Vison 2030 work considerations

• How many 510k tests have UDI?

  • think that is a requirement for getting the 510k

• what is the request process for UDIs?

Questions are what the best way is to find them in the FDA GUUID

in Europe also requiring use of UDI - they are using GTIN numbers “blessed as UDI”, which is based on packaging, this is very complex

Riki will ask Marti about the first 2 items

Australian solution to the “combine flag”

Looks like they are using a national reference website indicating the tests that are safe to combine, nver to combine or under review; default is to not combine.

CDC work on postmarket surveillance

Might be able to add more columns to get “LIVD file content published like this one - example: Certified Total 25-hydroxyvitamin D Assays

USCDI V7 Draft review

Dates that are important for CLIA: -

• Specimen collection date/time = observation effective date/time = clinically relevant time

• Specimen received date/time

• Lab analysis date (from instrument)

• lab result verified and released date/time

We should update the mapping here to include the new elements: https://confluence.hl7.org/spaces/OO/pages/256515226/US+-+CLIA+Elements+mapping+to+HL7+data+elements

Discussed Performance Time, Diagnostic Report Date and Specimen Condition and made edits on the confluence page

LIDR Patterns

• Biomerieux culture plates

• Toxicology screening vs confirmatory

• challenge tests

• urine dipstick variations

• required specimen pre-processing before running on instrument?

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 ​Feb 24, 2026 9 - 10 AM ET