2025-12-16 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 - regrets

Abbott / IICC

Carmen Pugh

long term lab professional

Laurent Lardin

Biomerieux

Ralf Herzog

Roche

Christina Gallegos

APHL

Kathleen Figetakis

WA DOH

Marti Velezis

Sonrisa / FDA

Follow up on UDI representation

UDI BackgroundPreview

• Out of scope: disposables, collection devices, calibrators, QC reagents and other devices without UDI available in the GUUID database

• Goal for the call:

  • Getting an idea of the intended use of the information about used devices

    • What kind of devices?

    • What aspects around each device?

    • What are the use cases?

• Focus discussions:

  • Instruments

  • Test kit/reagent

• Overview of what IHE LAW currently supports - not explicitly discussed

  • instrument DI and serial number (as PI) should be sufficient

  • INV segment supports testkit / reagent information which covers lot number and expiration date (PI) - may need to figure out the how to get the DI here (local test kit code, which can be looked up in LIVD) - that might allow construction from different sources

• Overview of what LIVD curently supports- not explicitly discussed

Notes:

• Review of the WA DOH findings:

  • Summary of findings on the UDI Background page liked above

  • Follow up questions:

    • Screening vs confirmatory method take out of LOINC - would there be impact?

      • can ask laboratorians

      • suggestion from LOINC would be to send that as separate field (maybe a different OBX; linked by OBX-4)

    • WA accreditation requirements vs CLIA requirements around devices?

      • CAP does include traceback to the instrument requirement for result

• Looking at GUUID to understand that a lot of the individual elements desired by Epis are available in the database, when you have the (DI element of the) UDI

  • Pro Code

  • Catalog number - surprised folks didn’t list it, as in other areas that’s the most common since needed for inventory tracking (also referred to as SKU#)

• POC tests also have UDIs in the GUUID - the reason only a few of the COVID tests did is that all of them were EUAs (normally not as common, so here would have manufacturer name, device name, model name (can provide differentiation if no DI is known, but this is not the same as serial number and maybe version can also be helpful))

Next call

Tuesday Jan 13, 2026 9 - 10 AM ET