2025-11-19 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

alternate

Epic

Dan Rutz

primary

alternate

Biomerieux

Xavier Gansel

primary

alternate

Roche

Nick Decker

primary

Roche

Open

alternate

Healthcare Provider

Indiana University/Indiana University Health/Association for Molecular Pathology

Mehdi Nassiri, MD

primary

University of Wisconsin-Madison

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA

primary

UT Southwestern Medical Center

Hung Luu

primary

UNMC

Scott Campbell

primary

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case - regrets

primary

Monica Harry

alternate

Regenstrief Institute

Marjorie Rallins

primary

Eza Hafeza - regrets

alternate

HL7

Julia Skapik

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick

primary

Christina Gallegos

alternate

Logica

Stan Huff

primary

alternate

CAP

Raj Dash - regrets

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ASTP/ONC

Sara Armson

primary

 OPEN

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

 Keith Campbell

primary

Victoria Derbyshire

alternate

Quorum evaluation (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business)

Currently we have 17 named members (2 open slots), so 2/3 = 11 is quorum (excluding chair and government members).

# of voting member per charter: 13 - 21

# of non-voting members per charter: 7

Open Meeting

12:09 PM ET

Conferences/Webinars

Update from AMIA:

Q&A Feedback: Problem is worse than what the presentation shows in terms of coding (person from a GA lab)

How to deal with LDT - different LOINC coding - how to address UDI assignment to those (may be the same, but on different sample types)

getting better idea of how many are LDTs vs commercially available - look at COSMOS data (Raj/Hung?) - create a paper to get idea about the percentage of LDTs producing lab results

Create a meta data element to indicate if LDT.

Hard to know how many tests are available in the US owverall (to get the denominator)

Making FDA 510k website be easier to use - searching by type of test rather than manufacturer

If test result needs to also have organizational NPI (though labs usually use CLIA) which entity validated the test (for commercial tests that would be the manufacturers) that might give us the LDTs

Next calls

All SHIELD Calls

• ​Nov 25, 2025

• ​Dec 16, 2025

General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to)

Special Topic:

​Dec 9, 2025 - Any Topic?

Steering Committee:

​Dec 3, 2025

CDC Forum Call in January 2026 Topic: UDI in HL7

Membership

#1 Waiting for official NLM representative since John Snyders departure from NLM - Raja Cholan is still working on getting a new representatives, asked to keep informed on any feedback that is NLM related

#2 Announced the open Steering Committee slots on the ALL SHIELD call in July - so far no nominations - reach out to ADLM - Riki will email her contacts and see what comes of it

#3 Steven Emerick is stepping down as Co-Chair for Vocab and Standards WG - we canceled the remaining calls in 2025 - hope to start that back up in 2026 - Julia still co-chairing

Serge’s proposals for raising awareness

Could we draft documents to get SHIELD visibility to HHS leadership - maybe an open letter, lab vision statement?

Potentially reference the ASTP Lab Interoperability Report (also includes possible actions, which shows the levers that are available using policy) and highlight what SHIELD’s focus is?

Maybe take a high level action described and then more clearly identify more granular actions that could be taken (connecting the dots) - make it more obvious to the non-SME groups

If SHIELD is not doing the advocacy work, who is doing that - are we working with them?

Working on adoption of standards and breaking down the barriers to adoption

Next step: Figure out what the message to HHS Leadership should/could be - review the Lab Report and find those things where we can connect the dots to get traction on standards adoption (given a vision for 2030)

Review SHIELD WG Deliverables and Milestone Grid

THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!! - will review again in January

LIDR White Paper

Hopefully we have sent this out for eVote by then

Standards WG Vocab Follow up

• Continue

  • On prior calls we discussed #1, #2, #4, #5, #6, #7, #8 and #15

• Any answer about access to COSMOS data? - Update from Raj and Hung on what they found - neither of them are on - next time

• Collect qualtitative result values from IICC - Riki asked, any way to get this from Labcorp, ARUP (Carmen will try to get some) and Quest (Riki to reach out) - goal is to make sure all concepts are in the SCT qualifier hierarchy

  • not looking for the TNP and other exceptional “results”

  • regardless of specific test, but if we coudl get these organized by method, we might be able to come up with method specific value sets in the future

Placeholder to get back to later

• Antimicrobial result reporting - CAP Informatics Commitee will request feedback from Standards and Vocab WG

• Other presentations to folks at FDA?

  • Data Standards Review Committee of the FDA – work with Helena Sviglin

  • FDA Scientific Computing Board (SCB)

  • Compass group lab