2026-04-07 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 - regrets

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Stan Huff

University of Utah

Ed Heierman

Abbott / IICC

Carmen Pugh - regrets

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 from last week:

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:

Reviewed the googlesheet - goal is to pick a few of the most common tests, identify all available tests and collect LIVD from vendors (or collect LOINCs and create LIVD content), check for any LOINC and SCT gaps for these - then we can include this as specific milestones in the vision 2030 letter and come up with phased goals for implementation

googlesheet has a few tabs:

• Top LOINCs = highest common ranked 100 LOINCs that are lab tests

• Approved PT Analytes = Analytes used in CAP PT tests - the top of the page has the link to the CAP test item catalog, which includes additional offerings besides CMS requirements

  • page 141 for example shows Hemoglobin A1c peer groups, so can find applicable manufacturers here

  • Dr Vesper provided the highest cost test for CMS payments (some are low frequency for high cost treatment like cancer drugs) to find those that are done very often

• Sequoia Pjt Labs = list of labs identified by clinicians of the Sequoia project as high impact

• PT&LOINC Overlap = combines the most common LOINCs with those available in CAP PT and identified by Sequoia

• Added after the call:

  • BMP = as example for the data collection tab for each of the panels we decide to do - this includes the steps to take

  • BMP_Glucose = as example for analyte LIVD file

Note that there are some calculations that are not in the CAP catalog, that we probably should include

also for some tests, PT results get reported differently than for clinical care - example is for blood cell differentiations those are done in PT in a web-portal, so not in LIS/LIMS

Stan also did a review identifying which of the top LOINCs could cover about 80% of test volume - he will look for that

Can look up what tests are available by analyte as 510k approved: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0

Decide to focus on these panels to start:

BMP

CBC

Lipid

SARS-CoV-2 = already have LIVD file = https://www.cdc.gov/laboratory-systems/php/livd-test-codemapping/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcsels%2Fdls%2Flivd-codes.html need to check what is missing from it and add it

Worksteps for the common tests LIVD file work:

Identify the panel we want to use to pick analytes

for each analyte:

• find the manufacturers:

  • use the CAP PT catalog to find the manufacturer that can be used for PT

  • could also use the FDA 510k by Analyte webpage to find those (maybe in addition?)

  • identify the UDI for instrument and testkits

• reach out to the manufacturer and request their LIVD file (or LOINCs)

• find all applicable LOINCs - we could create valuesets for these

• might need to find some of the other results that are not coming from instruments (calculations) to add to the LIVD file

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 Apr 21, 2026 9 - 10 AM ET