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

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 - regrets

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 - regrets

alternate

Logica

Stan Huff

primary

alternate

CAP

Raj Dash - regrets

primary

alternate

AMP

Robyn Temple - regrets

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 no quorum

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 Committe slots on the ALL SHIELD call in July - so far no nominations - reach out to ADLM - who will do that?

Conferences/Webinars

• SNOMED CT Business meeting need a few SHIELD introduction slides for Rob Hausam to present (since he is attending) as part of our feedback on container modeling in SNOMED CT for the eX-Health group in Europe - will be homework to review and eVote

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

  • When will slides be available to review - @Julia Skapik?

  • Reviewing the updated SHIELD handout - ​@Eric Crugnale​

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

  • Got feedback from ADLM about the ACCENT credit form: since SHIELD is a collaborative initiative, and not a healthcare product manufacturer or marketer, it does not meet the ACCENT definition of an ineligible company/commercial interest. SHIELD is a collaborative with 70+ groups involved, and while many of those collaborators would be ACCENT-defined ineligible companies/commercial interest, it does not mean you need to identify the commercial interest status of each group within SHIELD.  We just need to know if there's a financial relationship from SHIELD or directly from a group within SHIELD.

    • so we provided them with our employer affiliation and noted that APHL provides the zoom links and confluence pages and completed the application

  • Next Steps:

    • Review Slides before or on ​Oct 14, 2025 call

  • ADVAMed Tech Conference

    • Nick being part of a Data standardization presentation / panel and likes to get permission to talk about Collaborative Community work - you can always do that, just need to review/approve slides if formal presentation

Time critical things - MUST FINISH verbiage today, so we can do eVote in time for submission on Sept 29

• ​https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3453616246Open are due by ​Sep 29, 2025
  

  • See 2025-08-13 Topic #2 Call for notes of the first call, and made more updates on ALL SHIELD call ​Aug 26, 2025 and the SC call after that

Discussion:

Changes to the feedback were made in the confluence page directly

• Medical device / UDI related:

  • the same person reviews all elements in a class, so can make class related comment at class level or the individual element

  • US Core proposed modeling:

    • in device profile removed the implantable restriction = ​https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-device.htmlOpen

    • in USLabObservation link to device is not further constraint to must support - might want to suggest that as part of implementation guidance? ​https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-observation-lab.htmlOpen

  • need to consider how EHRs are designed currently:

    • there may be length restrictions on identifier fields, that the UDI format might exceed

    • separate fields for DI and PI are not the same as UDI (though if the format definition is known, which it will be, then UDI can be created from these fields)

    • DI is static (and can be in LIDR); PI is instance data and needs to be updated more often

    • UDI for implantable is one device/patient - manual data entry (or scanning)

    • Even if lab equipment doesn’t change often, if lab has more than one instance of the same instrument needs to be tracked for each result, so less scalable for a run of many samples to enter manually - consider workflow changes that are needed

    • Implementation guidance is good to provide, even if text in USCDI for the calss or element does not change

    • ASTP/ONC can indicate implementation guidance by use of SVAP (so could put V6 into SVAP 2026)

    • Would be good for SHIELD to provide best practice for implementation

  • Specimen Condition Acceptability - just briefly reviewed and wordsmithed

FYI

The LOINC Ontology v2 was released 9/22/25. register for the LOINC conference October 7-10 in Montreal, Canada and Virtual = ​https://loinc.org/conference/montreal-2025/register/Open

Register for the SNOMED CT Business meeting 19-22 October and Expo 22-24 October in Antwerp, Belgium and Online = SNOMED International October Business Meetings & SNOMED CT Expo 2025

Sequoia had Lab Data Interoperability Webinar (all day) to introduce their Data Usability Guide (was recorded, 290+ registered, about 150 attended)

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

Have gotten some votes, Jim added comments and is requesting to slim down the White Paper - send it back to the LIDR WG, who reviewed it yesterday and will resend for vote soon

Standards WG Vocab Follow up

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

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

Any answer about access to COSMOS data?

Collect quantitative 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?

Discuss:

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)

  • Waiting for Deloitte 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/Open )

    • 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.

    • Positive news to see if this can resume.

    • Question on when engagement from federal agencies will resume.

• Standards Updates and Vocabulary Working Group

  •  Next meeting Sept 25. Discussion the SNOMED Container terms.

• 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

• Request from e-XHealth project and HL7 Europe around remodeling the container hierarchy in SNOMED CT looking for input from laboratorians around some of the details

  • Update from Standards and Vocabulary WG

  • other topics around container:

    • model needs to allow for accommodating additives being added later vs being in applied by manufacturer

    • model needs to also allow for mapping to UDI (Medical device in USCDI) vs SNOMED CT

    • Timeline? They will be moving forward.

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

• 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

• ​Sep 30, 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

Steering Committee:

​Oct 1, 2025 - SHIELD member survey results and road map review

​Oct 14, 2025 - SHIELD Topic #2 call to review the ADLM slides

​Oct 15, 2025 - will we also meet?

Adjourned

12:59 PM EDT