2025-11-05 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 - regrets

primary

alternate

Roche

Nick Decker - regrets

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 - regrets

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

primary

Monica Harry

alternate

Regenstrief Institute

Marjorie Rallins

primary

Eza Hafeza

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

12:07 PM ET, quorum at 12:15 PM ET

Conferences/Webinars

ADLM slides vote was 1 vote short, but we held the webinar anyways

AIMA slides also was a couple votes short, but there was quite a bit of feedback and adjustments that happened and they were submitted by the deadline

Riki will give a SHIELD update to CSTE national ELR call for their December call (using SNOMED CT slides plus list of accomplishments) Riki did frame the ask around UDI usage expectations (from LIDR WG)) on the CSTE ELR call yesterday

Next calls

All SHIELD Calls

• Nov 25, 2025

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

Special Topic:

Nov 18, 2025 - SHIELD member survey

Steering Committee:

Nov 19, 2025

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

Roadmap section updates in response to ONC comments on the SHIELD roadmap

Reviewing Updated Roadmap: https://aphlinformatics.atlassian.net/wiki/download/attachments/3214147628/DRAFT_UpdatedSHIELD_Community Roadmap_20250402.docx?api=v2

Changes are highlighted with markup addressing these ONC comments:

1. Aligning the roadmap scope to the mission scope

2. Addressing the concern that all standards need training and education

• Still need to review this one: Reviewed 2Jul25 see page 5 added text.

3. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap.  ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).

Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an example implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

(Action plan of which solutions would improve intereoperability. Why were these solutions chosen for the path forward. What is needed? How do you know this is the right path forward? Where’s the evidence this will work? )

For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption.

Discuss:

• Start at page 17 in this updated document:

• Motion to approve the updated Roadmap - Hung Luu, Mehdi Nassiri, no further discussion, against: 0, abstain: 1, in favor: 10

Review Working Groups progress

THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!!

Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid

Reviewed and made updates on that page

LIDR White Paper

We will send that back for vote with the understanding that this is published on the SHIELD confluence page and then we will write shorter articles to submit to journals (and could reference this then)

Standards WG Vocab Follow up

Continue LRI Review Summary DocumentPreview

On prior calls we discussed #1, #2 and #15

Any answer about access to COSMOS data? - This is customer based, Dan shared information on how to connect to Raj, so he could check for Duke; Hung also has access, he will check what he can find out.

Collect qualtitative result values from as many vendors we can - what would be the best way to get this? In 2018 (or was it 2020) several vendors had lists; would be good to get a list so we can make sure SCT codes are available for those - who has this action item? Riki will ask IICC

Discuss:

Today we talked open issues #4, #5, #6, #7 and #8 - added comments on that page

Placeholder to get back to later

• Electronic Health Records and Genomics add to a resources page - another paper should be forthcoming next year from same WG

• Antimicrobial result reporting - this got moved to being a CAP Informatics Committee project - Related work at HL7 Europe: - Hung will give update and 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