2026-03-31 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 from last week:

Goal is to focus on interfaced data

UDIs are linked to the result values

Full UDI needed for end users

Is it beneficial to be able to know device category = instrument / test kit / reagent / controls / calibrator / consumables?

Discussion today:

https://isp.healthit.gov/taxonomy/term/2376/draft-uscdi-v7 = Device type added in V7; represented in SCT - GMDN will be an extension in SCT (https://www.snomed.org/news/gmdn-agency-and-snomed-international-announce-strategic-collaboration-to-advance-global-medical-device-content-and-interoperability )- could represent the device type, though that is more detailed than the category mentioned above

in IHE LAW, would know if instrument (from OBX-18) or something different (INV segment), because these come in different message fields

LDT - would still be a lab test, would have the UDIs (may not be in the GUUID), if using commercial products rather than making their own reagents, though not FDA approved

Need to also include software that is considered a medical device - for algorithms in calculations

• need to also include the LIS - when the calculations are done there (it has the demographics that affects the choice of formula)

• what about formulas? - not sure those have UDIs - that may be methods (captured in LOINC code - example eGFR LOINCs, though not sure if that captures the different sex aspects of the formula)

• at Home performed tests - different performance (not showing quant results) - does that affect LOINC choice?

If we don’t need to send the category along - most pragmatic would be to send everything in OBX-18, as that is supported in older v2 messages

Jim Harrison is working on PT message spec, which is just one use case, though goal is to have the same message spec for PT and patient result reporting

Reviewed Top Lab LOINCs against CAP’s PT catalog - some results are reported slightly differently - for example calculated LDL is not included (vs direct LDL) - would need to look at these patterns

Hematology PT testing is not using instruments for image results for cell identification

Content may vary for the PT testing for some of these top lab tests; SHIELD focus should be for the top lab tests, even if some are not part of PT

Which of the tests in panels do we include in our list of supported codes? Assume we support the clinical results and ensure that we have LOINCs and SNOMED CT - maybe we find some gaps in UDI (potentially for calculated results)

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

USCDI Draft-V7 Feedback

CDC requested elements = see publications that support collection / use of some of these: UCSDI V7 Element Support

I did 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

• https://uscdiplus.healthit.gov/uscdiplus?id=uscdi_record&table=x_g_sshh_uscdi_sub_domain&sys_id=b159d5111ba19e101ceb0e1ce54bcb3c&view=sp - list of data elements under Adverse events

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

• https://uscdiplus.healthit.gov/uscdiplus?id=uscdi_record&table=x_g_sshh_uscdi_data_element_parent&sys_id=ab8867dc1bba725049edc957624bcb4c&view=sp - 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 Apr 7, 2026 9 - 10 AM ET