2026-05-19 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

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:https://docs.google.com/spreadsheets/d/1zpbjDmWgA-RQW8fJdTe5kHZG6LwAAVzqeCHxhCNXR4g/edit?usp=sharing

Discussion today:

Stan googled for the BMP instruments, got a list of 20 instruments, then googled for UDI for this and came up with several and then looked that up in the GUUID website, but didn’t find the same often

Andrea points to the FDA approved instruments

Suggest to reach out to the manufacturer and request LIVD files

Add examples of what is problematic with using this site https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0 :

• CLIA considers a test system the instrument+test kit, so that part is helpful, but that is just on the second page of the listings, so requires to look at every entry in the first table

• the table does not indicate, if the test system is still available

• there are so many test systems and the webpage only exports the first table, not the content for each of those entries

• If we still had a good FDA contact, could we reach out to get those pulled from their data base?

Call adjourned

9:30 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