2026-02-24 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

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: UDI Background

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?

• what the best way is to find them in the FDA GUUID

Waiting for answer

USCDI V7 Draft review

USCDI Draft-V7 Feedback

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

See publications that support collection / use of some of these: UCSDI V7 Element Support

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: Device Type, Diagnostic Report Date, Medical Device class and UDI - made changes directly on the feedback page

Really need a data model to get to interoperability for each use case

Having the current classes potentially creates a confusion across different domains, about which are appropriate to use (if the classes themselves are not use cases, they should not be used for grouping)

Different domains have different needs, including different data elements, so focusing on each domain / use case and identifying all elements needed - for example using the procedure class for orders, which has different vocabulary bindings than the laboratory orders element in the Orders Class (which didn't exist in older versions of USCDI).

Do we need to mention that any newer versions of the report need to be made available to other downstream users (like copy-to-providers)? - not sure we can attach that requirement to a single data element

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 Mar 3, 2026 9 - 10 AM ET