2025-04-22 LIDR Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Xavier Gansel

Biomerieux

Pam Banning

3M - Solventum

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Stan Huff - regrets

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Marti Velezis

 Sonrisa / FDA

Walter Sujansky

FDA

Susan Downer

JMC

Ralf Herzog

Roche

Cornelia Felder

Roche

Daniel Golson

JMC

Andrea Prada

JMC

Maria Sagat

CAP

Russ Ott

FDA

Akila Namasivayam

FDA

Desiree Mustaquim

CDC

Carmen Pugh

long term lab professional

Christina Gallegos

APHL

John Spinosa

Lantana

Matthew Dietz

FDA

Logistics

• Next meeting: May 6, May 13, need to check on May 20

• Consider connectathon for LIDR - update?

• LIDR White Paper under SC review extended until April 16th - not yet discussed

  • OPEN ACTIONS - no update on any of these:

    • Review again for making sure it doesn’t look like LOINC is a bad standard - we don't want to perpetuate inocrrect information - it is not a LOINC issue, it is trying to highlight the issue with modeling lab tests and how folks apply LOINC @Stan Huff

    • Review Figure 6 and associated text against Figure 8 and associtated text and combine / adjust as needed @riki.merrick

    • Add in Reference to AUTO 16 and provide the mapping between LIDR entries and instance data @Russell Ott (Unlicensed) to check for his version of the mapping file

    • Review the LIVD/LIDR requirements section to ensure we have the proper vendor view @Xavier Gansel and @Ed Heierman

Integrated Knowledge Management (IKM) development

https://www.ikm.dev/

LIDR pilot participation - current focus is on SNOMED CT, still adding in support for LOINC and UCUM etc

Will get update on timeline to support other code systems? still working on LOINC ontology

LIDR Googlesheet Potassium and more LIVD data

Blue column headers = LIVD file columns

Yellow column headers = additional meta data

Pink column header = codified information derived from LIVD columns

green column headers = other data of interest from package inserts

light red = other data elements of interest

On Potassium Tab reviewing the colored cells:

• orange - some follow up needed - for rows 18/19 - only difference is method description in Vendor Analyte Name column and Vendor Analyte Code (marked yellow - why is 987 in both rows?) - using the same methodless LOINC - Roche question!

• Need to expand to some organism tests to see, if we can find patterns there that require additional columns

• Should we include AOEs in LIDR output? - might be helpful to labs to have when building their compendium, but they may already have those as part of their dictionary

• we should identify all columns that should be included in the LIDR output

  • this depends on the scope:

    • do we want to support all elements needed to understand / interpret the results

    • support other lab workflows

• Riki to find the other data elements that other groups collected during COVID and add to this googlesheet header (actually I will add as separate tab so we can add definitions for all column headers and how we anticipate those being used -added as “ReadMe”)

• wouldn’t it be nice to have package insert content in strucutred format (APHL is currently trying to publish a paper arund the SARS-CoV-2 LIVD work along with other groups (AdVeritas, Center of Complex Interventions, NIH) and how cumbersome it was to get the data out of the pdfs, getting notified when updates were available, dealing with changing format of the web pages etc.

  • some examples of fields from package inserts:

    • CLIA complexity

    • cross reactivity

    • patient population for verification

  • might be good to have local version for the LIDR entries that are pertinent to the lab (rather than having to go lok for the pdf package insert every time)

  • it would also be good for the 510k documentation to have more strucutred data available for searches (was very hard to find potassium tests)

• If we expand what we include in LIDR output, we should write an implementation guide to help folks use the output properly

• added second tab for Pro NPB testing based on Biomerieux’s LIVD file, which Andre extended with some entries from Mayo and Stanford compendium as comparison what needs to be in there and this email:

Reviewing minutes from the last call - 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 5/6/2025 9:00 - 9:55 AM ET

Adjourned

9:48 AM ET