2026-06-30 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

Manjula Dharmawardhana

CDC

Jim Harrison

CAP

Follow up on UDI representation

Adding Conclusion here: UDI Background - @Hung Luu - do we need to update this page with the notes from the last couple of side meetings?

Summary decisions so far:

Goal is to focus on interfaced data

UDIs are linked to the result values

Full UDI needed for end users

No need to have the types identified - if you can look up by UDI, just do that

consider software as a medical device (specific algorithms)

FYI = Answers to the questions around UDI:

• How many 510k tests have UDI? You would have to query the database using FDA product code and hopefully trap the entire list of IVD tests - i.e., there are many product codes and I am sure an office level search will result in too many non-test products (i.e., instruments, etc).I think that is a requirement for getting the 510k - Yes, most 510K submissions fall under the UDI Rule.

  • We need to better understand the actual number - who at the FDA would know? How can we find that out?

• what is the request process for UDIs? FDA does not issue UDI-DIs.  They are created by the Labeler (US) based on the requirements of the Issuing Agency (e.g., GS1, HIBCC, ICCBBA).

   

• what the best way is to find them in the FDA GUDID?  Same response as finding 510Ks - you will need to either search by FDA product code or GMDN code to see if you could locate all of the products you are looking for -- I do not think this is an easy process to ensure you have 100% of the tests.

  As you may remember -- even finding the test kit and analyzer was difficult.

I am not sure even AI could make sense of this one yet....but it is worth a try if someone has time to create some prompts.

• We would have to know how things are named to find them, so that is an issue.

Follow up from IHE discussion - use of LIVD may needs some updates
instruments are global, so the UDI may not be the same for different regions; as the tests are often set up for different regions

adding vendor specific testkit IDs:

Open

Australia was asking for support of QC material, not the actual QC result; Example

OBX|... result of patient
INV|||QC|
INV|||Reagent1
INV||Reagent2

INV||Calibrator?

For proficency testing - these are not normally reported out of the lab; IHE is writing a profile for this communication = PMW

outside of the lab - in LRI or LTW:

OBX
PRT
PRT

There may be remapping needed from instrument to get the clinical context added => LIS - EHR-s for some of the tests (challenge tests for example) - this functionality needs to be provided by the LIS (or middleware).

Need to have education for these type of tests about what is needed to be transformed from the instrument to be reported - so LOINC will need to be changed, additional results may need to be added for calculations

Need to figure out how the UDI figure into the pattern of reagents UDI and results; the instrument UDI.

you need to know what was involved in creating the result: instrument, reagent, QC, maybe even the person who performed it

need to consider patterns of set up - devices and elements needed for different lab domains

See if we can continue this with LIS + more IVD vendors

Vison 2030 work considerations

SHIELD focus should be for the top lab tests, even if some are not part of PT - see here for current thoughts:Common LOINCs for LIDRPreview

Discussion today:

using these CLIA - Clinical Laboratory Improvement Amendments is very hard, there is API functionality, how best to get this data out - send feedback to FDA about what is useful

Enhancing CLIA Act 2026 - creating a database for LDTs - could we figure out a way to structure this data when this is set up

We also don’t know what all is being tested for nationally

maybe set up all the LOINCs for the common results = common specimen + common methods and collect those on the individual tabls, so we have a stratign point of just a few LOINCs per analyte - capture those on the LIVD formated tabs for each analyte, even if it is just 1 or 2 LOINCs per tab without any manufacturers associated for now.

Call adjourned

10:02 AM EDT

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

Going to twice a month for meetings to allow for homework time, so next call Tuesday Jul 14, 2026 9 - 10 AM ET