2026-03-17 LIDR Meeting Notes - no quorum after 10 min

Hung Luu - regrets

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

Follow up on UDI representation

Adding Conclusion here:

Will keep filling this page out to collect all solutions there.

Note that we will have a special call to work out where to send the UDI for the test kit on the LIDR WG call on Tuesday, March 24, 2026 9:00-10:00 AM ET – from discussion these are the choices to discuss:
OBX-17, OBX-18, INV-1, SID-1, PRT segment.

Vison 2030 work considerations

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.

  • Marti and Keith are trying to get a number (or find a good way we could find that out ourselves)

• 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):

  1. Select an FDA-Accredited Issuing Agency

  Choose one of the FDA-accredited issuing agencies to obtain your device identifier (DI):

  GS1 (most commonly used)

  HIBCC (Health Industry Business Communications Council)

  ICCBBA (International Council for Commonality in Blood Banking Automation)

  2. Obtain a Device Identifier (DI)

  The UDI-DI is ultimately assigned by the Labeler based on the Issuing Agency’s instructions (e.g., GS1 GTIN Allocation Rules).  Note: there is a fixed part of the value (e.g., GS1 Company Prefix that is assigned by a GS1 Member Organization).

  The DI is the mandatory, fixed portion of the UDI that identifies the specific version or model of a device. 

  3. Assign Production Identifiers (PI)

  If applicable, assign production identifiers such as lot number, serial number, expiration date, or manufacturing date. These variable portions of the UDI change with each production batch or unit. 

  4. Submit Information to GUDID

  Enter your device information into the FDA's Global Unique Device Identification Database (GUDID): 

  • Create an account in GUDID

  • Submit required device information including the DI, device description, labeling information, and other attributes

  This must be done before the device is distributed.

• To answer the question of why we were asking - getting this info easier: No, you would have to go to all of the IVD Labelers to ask them to send you the information directly.  The issuing agencies do not assign the information and not all of the labelers use the data pools/services where that information may be consolidated (and if it is – it would most likely cost money to access). 

   

• 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.

• If the ask is to have FDA come up with an API for IVDs – we could take that back to the FDA UDI Program.

USCDI V7 Draft review

CDC requested elements = see publications that support collection / use of some of these:

We should update the mapping here to include the new elements: https://confluence.hl7.org/spaces/OO/pages/256515226/US+-+CLIA+Elements+mapping+to+HL7+data+elements

Discussed:

• Should review CPOE elements for those data elements that are required for the lab, for example:

  • specimen collection and source sites for the prostate biopsies to calculate the Gleason Score

  • LMP for Pap smears - is actually written into CLIA

  • How are AOEs covered in USCDI?

• Follow up from the SHIELD Topic #2 call: Sara stated that re-submitting comments does make a difference, especially if focused around these 4 questions:

1. Provide comments on the name and definition of data elements

2. Identify other widely exchanged data elements that could be added - from other USCDI levels or USCDI+

3. Identify if the proposed data elements are being exchanged today between health IT systems

4. Show that these data elements are broadly usable across healthcare use cases and specialties

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

Tuesday ​Mar 10, 2026 9 - 10 AM ET