2026-07-28 LIDR Meeting Notes
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2026-07-28 LIDR Meeting Notes

Date

Jun 30, 2026

Attendees

Bolded names indicates attendance

 Name

Organization

 Name

Organization

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 = this page needs to get updated with the discussions from the last couple of LIDR WG notes!

Discussion today:

LIS vendor feedback:

  • currently has support for OBX-18 (instrument), but reagents / test kits are not currently stored - change in requriement to store reagent information in LIS

  • hematology and basic chemistry probalby easiest

question if pre-treatment of reagents also would need to be communicated; that would not come from the instrument, that is a human knowledge step - that would need to be done by another means - let’s leave that off for now

should we store these details in middleware?

what about system fluids etc?

Whether calibrators and all these additional items need to be associated with the result is regulatory

will need to support a many:many mapping between result and instrument / reagents

support for calculations from instrument

Data flow from instrument → optionally middleware → LIS → EHR-s; from there other users can get these data is the goal we think

Need to get LIS vendor input on current state and preference of use of OBX-18 alone, PRT alone, or a mix of both = there is no forum to easily reach all LIS vendors, so look at last CAP LIS reviews for AP (https://www.captodayonline.com/comparison-page-products/#anatomic-pathology ) and CP LIS vendor contacts (https://www.captodayonline.com/comparison-page-products/#lab-information-systems ) - Riki to draft the ask

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:

Andrea was able to get LIVD file for Abbott tests when used for the chosen common tests - will transfer the LOINCs from there into our spreadsheet - not actually creating the LIVD files for each of the tests, but rather create a list of all applicable LOINCs for these common tests for use in US

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

Next call

Going to twice a month for meetings to allow for homework time, so next call Tuesday Aug 11, 2026 9 - 10 AM ET

Chat

Andrea Pitkus 9:12 AM
and the instrument wouldn't know any pretreatment reagents that are not on the instrument too

Andrea Pitkus 9:19 AM
Amy can you support multiple instruments for a single value or only a single instrument?

Andrea Pitkus 9:20 AM
IN other words a 1:1, 1:many, many:1, and many to many?

ganselx 9:20 AM
I am unsure what you mean, Andrea ?

Andrea Pitkus 9:23 AM
for the multiple instruments or the preprocessing?
There are a few chemistry tests that require a lab professional to use a "reagent" not on the instrument to "pretreat" a specimen.  Perhaps to create a eluate that is then analyzed on the instrument and not the original specimen.
This would be an example of many reagents (potentially many instruments) leading to a single result value.

Andrea Pitkus 9:29 AM
The hematology CBC example typically involves multiple reagents for results (and combinations vary depending on result and which size cube the laboratory is using):  CELLPACK (diluents)
LYSERCELL (lysing agents)
FLUOROCELL (fluorescent dyes/stains)
SULFOLYSER (hemoglobin reagent) (These are from Sysmex, a major global IVD vendor).  This is a bit different than the chemistry/immunology patterns we've discussed.
does that answer your question?

Andrea Pitkus 9:39 AM
For cultures, multiple means may be used to identify an organism from the culture plate/media upon which the organism grows as usually not the original specimen (but as this use is expanded)

Amy McCormick 9:54 AM
https://www.captodayonline.com/laboratory-information-systems-2024/

Action items

Stan Huff will collect data for BMP based of https://loinc.org/24321-2/
Hung will collect data for CBC based of https://loinc.org/58410-2/
Christina will compare the SARS-CoV-2 LIVD file entries to the FDA list https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0 and identify any that are missing