2026-03-24 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:

Discussion today:

reagents and kits are more consumables compared to equipment, but there are also other consumables; it would be good to have a mechanism that allows us to identify the type of equipment we are sending UDIs for

the requirement is to capture what was used to produce the result value (like reference range and units of measure) - the LIS needs to record, so that it is available for retrospect (so not just pass-through)

focus on UDI for instrument + consumable kit

LIS might have to also capture more, but only the full UDI for the instrument + test kit/method is needed, but that is needed for the EHR-s, when they exchange between each others, to understand if result values are comperable (Epic is working on new system to support that for their customers going forward - not yet in Happy Together)

Unserstand that not all result values are coming from interfaced analyzers, but focus on that aspect for now - we can only control the format / vocabulary of what is exchanged, not how vendors enable the storage or exchange functionality inside their systems.

OBX-18 does not have a field for ‘type’, PRT has a field for participation role, might need to extend the vocabulary for that field, to support more types of equipment.

We will have to find another time to get back

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.

  • 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.

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:

Review ​Mar 3, 2027 notes about email on Adverse Events

• - list of data elements under Adverse events

  • we don’t need to add anything to the comment we have

• - Lab Test Date/Timestamps

  • this seems to cover several of the ones we were discussing on the specimen call:

    • results from instrument

    • results verified (could be auto verified or by a person)

    • results released (which often could be combined with verified, but may depends if verified by algorithm or human)

  • Result Interpretation (already in UCSDI) has issue:

    • listing both HL7 ObservationInterpretation code system (which is harmonized across all HL7 products) and SNOMED CT, which most LIS cannot support for that field (assuming EHR-s also don’t)

    • this is OBX-8 in V2 messages

    • this is issue, because of sensitivity reporting, which must be done in either OBX-5 (Result Value) or OBX-8 (Result Interpretation) based on CLSI requirements

    • was discussed in vocab WG during review of LRI

    • Should create a crossmap between SNOMED CT and ObservationInterpretation and then could move HL7 to adopt SCT instead ot allow for merging of these from both OBX-5 and OBX-8

• Looking at other levels in USCDI:

  • Accession number?

  • bad definition for Lab Test Performed Date

• 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 covers 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 31, 2026 9 - 10 AM ET