2026-01-13 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

UDI Background

Follow up from WA DOH survey:

Removing the screening vs. confirmatory distinction from LOINC could have an impact for public health epidemiologists, especially for conditions like HIV, syphilis, viral hepatitis, and some other STIs where that distinction is important for case classification, deduplication, and interpreting trends. Method-based distinctions (e.g., GC/MS vs. immunoassay) are useful, but they don’t fully substitute for knowing whether a test was used for screening or confirmation from a surveillance perspective.

Specific to COVID sequencing, WA DOH may ask labs to additionally clarify reason for ordering/performing, including 'SENTINEL SURVEILLANCE', ‘CLINICAL’, 'SUSPECTED REINFECTION', 'SUSPECTED VACCINE BREAKTHROUGH', 'TRAVEL ASSOCIATED', 'OUTBREAK' and others.
In the outpatient clinic world, insurers also may also be looking for distinction between screening and confirmatory testing. Reimbursement policies may pay for confirmatory but exclude screening. These could be coded differently, so may be using different CPT codes and ICD 10 codes. An example is CA-125 testing which may not be covered by some insurers if performed for screening purposes but would be covered in the presence of ovarian cancer.

From LIDR perspective:

Would the test have different UDI based on “screening vs confirmatory”? Probably not, but would still need to think about, if there are different reference ranges / cut-offs associated with that. Currently “screening” is in the test name in the lab menu (in LOINC it has been in the methodology so far”) - Would those be in LIDR, too? Sent every time with the result?

Also SAMSHA regulations have different cut-offs based on the type of test

Could labs set this up as panles, to include the additional clinical context of screening vs confirmatory.

We haven't discussed how LIDR will handle XXX fields too
whether for the Specimen/source or challenge details as Stan mentioned

Not sure this belongs in the UDI - will have to find a strategy to convey this aspect of the test.

Next steps for UDI representation?

The most granular use case needs the full UDI

For instrument DI+ serial number can construct the full UDI, but for reagents might not be able to, so need to look at adjustments needed for AUTO-16:

• First repeat of OBX-18.3 and OBX-18.4 make RE so that the DI can come over

• Optionally could send the full UDI in first repeat (but would still send second repeat for the serial number)

For reagents / test-kit: AUTO-16 uses INV segment (not OBX-18): Would need to add description of using the DI as the code in INV-1, where the text is the analyte name and the code system is the producer of the DI (GS1 for example) (INV-1 is a CWE datatype)

For calculated results would need to understand all the elements that are involved in the creation of those - Abbott defines a special test for these with its own UDI

CBC with auto-Diff: sometimes switch to manual, so the UDI would be adjusted accordingly (there is a flag in the LIS that handles that)

Also need to check how this would then be communicated out of the LIS - look at LRI when we are working on the NAACCR profile

Make a plan to get folks to adopt existing functionality to properly map LOINC and SNOMED CT and we need to support the correct mapping for the instruments they use and keep that updated

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

• State of LIDR tooling: Waiting for response about Biomerieux content in KOMET = LIDR (is in GitHub here: https://github.com/ikmdev/komet)

• 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 Jan 20, 2026 9 - 10 AM ET - Jan 27 overlaps with HL7 WGM, so we cancel!