2026-05-04 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:

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.

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:

Did Stan find his review identifying which of the top LOINCs could cover about 80% of lab test volume - it’s the same that resulted in the LOINC ranking

Discussion today:

Consider POCT as out of scope - so exclude waived tests

consider looking at simple tests, maybe Hemoglobin A1c

Found 337 in FDA CLIA search - see example download (only includes first listing - when you click on each entry on the webpage, get more detail on the test kit - in some instances the name we have for SARS-CoV-2 is not on the first page, only on the second page):

does not include the UDI

look up in GUUID - example print out of info findable there:

look at high clinical impact / patient care/safety

identify gaps in LOINC / SNOMED CT for qualitative results

Next call ​May 19, 2026 - it is overlapping with HL7 WGM, so let’s cancel that and regroup ​Jun 2, 2026

Call adjourned

9:38 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 ​May 19, 2026 9 - 10 AM ET