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 - regrets

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- regrets

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick- regrets

primary

Christina Gallegos - regrets

alternate

Logica

Stan Huff - regrets

primary

alternate

CAP

Raj Dash

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ASTP/ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

 Raja Cholan

alternate (checking)

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

12:08 PM ET

Conferences/Time critical things / FYI

AMIA November 15 - 19 in Atlanta, GA https://amia.org/education-events/amia-2025-annual-symposium/call-participation was accepted

ADLM webinar about SHIELD is scheduled for October 22, 2025 12 - 1 PM ET

SHIELD Charter Updates

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3071279178 -

Missing votes from 4 members, 2 of whom are still OOO, so will wait a bit longer and do another follow up email before the August meeting.

Note: Changes to the Charter require unanimous approval by the Steering Committee!!

Next Steps:

Review SC participation (As of now need to still add the dates the Votes went out) and put this on the ALL SHIELD call

https://grants.nih.gov/grants/guide/notice-files/NOT-LM-25-002.html

Was due by Jul 14, 2025, but unfortunately we only got 7 responses, so we did NOT submit this

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/2020966449

Riki still has to send out the email to request a vote (didn't want to overlap with the NLM feedback and charter eVote so have not sent out yet) Didn’t have quorum on the call, but recorded votes from those on the call.

Standards WG Vocab Follow up

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3347447812

Please review and provide comments - aim for August

See https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3347447812 for discussion items from today’s Steering Committee on the 15 Open Items/Items for Potential Action (especially #1 and 15). Great discussio10

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:

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

• Laboratory Interoperability Data Registry (LIDR) Working Group

  • Waiting for SC review of the LIDR White paper (see below)

  • Working on a pilot project with KOMET and Biomerieux

  • 4th Tuesday Cadence of meeting once a month

• IVD Data Hub

  • Exploring finding funding opportunities - current talks with Truveta (https://www.truveta.com/ )

    • No update since last time. Been holding with limited attendance. Looking to pilot use of their systems. Unclear what can be done without funding. Federal folks haven’t been able to participate. Nick will chat with some of the IVD folks on trying to recruit more folks.

• Standards Updates and Vocabulary Working Group

  •  Met 15Jul25. Stan provided an overview of the new LOINC Order codes coming in August LOINC release. They tend to be methodless, and some are systemless (XXX,specimenless) and curated from result LOINCs.

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

  • Continuing to review survey results. Many great comments. Working through free text comments. Have slides prepared. Had to move meetings that overlap with Steering Committee.

  • Lab Orders. Australia is working FHIR based e request. Providers send orders to central repository, mapped to SNOMED CT for lab orders. Reach out to Eric for more information.

Placeholder to get back to later - NEXT TIME

• https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltext AMP paper - do we need to do something with this as the Steering Committee?

• Antimicrobial result reporting

  • Related work at HL7 Europe:

• https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltext

• 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

Next calls

All SHIELD Calls

• Jul 22, 2025

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

Special Topic:

• Let us know if you have topics or speakers of interest

Steering Committee:

• Aug 6, 2025

Adjourned

 1:01 PM ET