2025-06-18 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 - regrets

primary

Roche

Yue Jin - regrets

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 - regrets

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

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

 Raja Cholan

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 no quorum

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 reached out to request a webinar about SHIELD later this year to be scheduled in August or later

We got enough votes to Sign on to the CLIAC FACA APHL SignOn Letter follow up - thank you

Version of the latter as sent:

https://www.federalregister.gov/documents/2025/05/16/2025-08701/request-for-information-health-technology-ecosystem

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3346530480 - we got enough votes and ai added the pdf version of what was posted to the top of the confluence page

Steering Committee Composition Question

Adjusting Stan’s Participation category since Graphite Health is no longer, but Stan is still on the board of Logica - that is a public private partnership, not for profit, so leave under professional organization

https://www.federalregister.gov/documents/2025/04/23/2025-06967/exploration-of-health-level-seven-fast-healthcare-interoperability-resources-for-use-in-study-data

Due by Jun 23, 2025 - so need a vote by EOD 6/22 - will do via email, if needed

Discuss:

Focusing on USCDI feedback is good - mostly geared towards getting data out of EHR-s, but maybe good to also provide a bit of background on how the lab data gets into the EHR-s (via V2 or scanned paper reports / downloaded pdf, especailly if not created in the in-house lab - in-house lab data has the best chance of being discrete data - next would be quantitiative results (for chem / CBC etc); unclear if the LIS module of EHR-s can handel the FHIR access or not. Some labs do provide access to results via FHIR APIs for patient portals, so may be usable).

Also point out discussions still ongoing at HL7 about panel representation in FHIR (use of DiagnosticReport vs observation.hasMember), which might impact access to the data (as pulling just individual observations out of a panel might loose some clinical context (for example the Ainon Gap)

Also cancer results are not often discrete - even though the Cancer Reporting FHIR IG was named in the latest Promoting Interoperability Rule, it is not implemented and has not been tested enough to know if it will work - also having issues with the proper grouping of the observations.

Research sponsor can complie the data however they want, unclear how sponsors keep the data, if discrete or converted or otherwise adjusted, especially for clinical trials that are organized at different organizations

Next Steps:

Riki to draft the additional feedback and send via email to SC members by EOD Jun 18, 2025,

All to review and make edit on confluence (via comments) - Final vote on submission is needed by EOD Jun 22, 2025

Riki to submit Jun 23, 2025, if approved by quorate vote

SHIELD Charter Updates

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3071279178 - Review the updated Article Three of the Charter as a whole

Discuss:

Reviewed the proposed wording for participation:

should have a means to follow up on missed meetings (not all are being recorded, so then would need to read minutes) - also participating in online editing of documents / email votes is participation

Notifying of missing the meeting does not make up for missing the meeting, but communication helps and planning can happen (and other forms of participation still count)

From a process perspective we could add an Agreement letter that Steering Committee members or WG Chairs sign, so that all are at least aware of the expectations

Since we don;t have a borad structure, we don’t really have a third party to adjudicate appeals, so proposed parocess flow:

Notice of lacking member participation

Chair or designee reaches out to member for explanation

Working out plan for member accommodation with appropriate participation so that Steering Committee function is not impaired

No plan can be worked out, or continued non-participation by the member, the Chair annouces the member’s termination with a 2 week period to appeal to the Steering Committee

Ifno appeal, decision is final, if appeal, SC will hear the appeal and make final decision at time of meeting (eVote)he appeal and make final decision at time of meeting (eVote)

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

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

Due by Jul 14, 2025

Will have to read for relevance to SHIELD before we decide if we want to respond - If anyone has bandwidth, please make a note here:

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

Review and Vote?

Discuss:

Standards WG Vocab Follow up - NEXT TIME

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

Please review and provide comments - will take this up in early August 2025

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

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:

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.

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 - NEXT TIME

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

• 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.

• Standards Updates and Vocabulary Working Group

  •  Getting everyone on the same page after restarting

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

  • Continuing to review survey results. Had to move meetings that overlap with Steering Committee.

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

• June 25^th

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:

• Jul 2, 2025 - Riki is out, but Andrea and Christina can run the call

• Jul 16, 2025

Adjourned

 1: ?? PM ET