2025-08-06 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

primary

Roche

Open

alternate

Healthcare Provider

Indiana University/Indiana University Health/Association for Molecular Pathology

Mehdi Nassiri, MD - regrets

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

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

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 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 - so far no nominations - reach out to ADLM

Conferences/Webinars

• AMIA November 15 - 19 in Atlanta, GA AMIA 2025 Annual Symposium Call for Participation was accepted

  • Aim to review the sides for next call

  • Reviewing the LOINC meeting handouts about SHIELD and will send out for comments and approval vote later today

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

• Andrea attended ADLM vendor exhibit hall - reached out to IVD vendors (asking about LIVD and USCDI) and LIS vendors and invited them to participate in SHIELD

Time critical things

• USCDI V6 was published Jul 24, 2025 https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi#uscdi-v6 along with https://www.healthit.gov/topic/standardsbulletin_25-2 for background

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

    • We want to re-purpose the Aug 12 call for work on this - Riki will check WIth Cornelia, if the How to send UDI in IHE LAW slides can be shared more broadly - if yes, will include as background info for the USCDI V7 Suggestions call, else will just send email notifying the larger group

FYI

• SHIELD Webinar now available on ASCLS: SHIELD as a Mechanism to Support the Adoption of Common Standards for Laboratory Data Interoperability | Labucate - there is a small fee to watch it

• HIT-4 was released Jul 31, 2025  https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-electronic-prescribing

  • focus is TEFCA, ePrescribing and prior Auth

  • ELR and TEFCA as optional item for reporting - pointing to the Sequoia Project SOP for ELR, which only included FHIR observation (missing any input around other FHIR resources) - not sure about V2 content via TEFCA - this might need some review

  • Unclear if it goes into effect Oct 1, 2025 or in 2026 sometime

  • Webinar Aug 12, 2025 1 PM EDT  (link to regiser is in the linked announcement above)

• White House, Tech Leaders Commit to Create Patient-Centric Healthcare Ecosystem | CMS

  • from the Interoperability Framework | CMS:

  • By April 1, 2026

    • #12 Networks must provide or facilitate access to data using FHIR APIs, that adheres to the US Core FHIR implementation guide, including full FHIR capabilities statement and USCDI V3 (or later) with terminology compliance (e.g., labs in LOINC, meds in RxNorm, conditions in SNOMED). Networks should leverage FHIR Bulk data exchange to reduce stress on existing systems and enable the exchange of full data records.

• 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

  • Need to add Andrea’s feedback:

  • plan on bringing this to the 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

SHIELD Charter Updates

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

These changes have been unanimously approved!!!!, so I can create the new final version to post

Review SC participation - how often?

Discuss:

Decided we will check twice a year, may be in December and June

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.

Will send email today requesting a vote

Standards WG Vocab Follow up

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

Last call we discussed #1 and #15

Any answer about access to COSMOS data? Dan not on, so no answer here

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

Discuss:

Made comments in the other confluence page - discussed Item #2

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

Not discussed

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

Not discussed

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 (EHR data and analytics | Truveta )

    • 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 - Not discussed

• 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

• Aug 26, 2025

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

Special Topic:

• Aug 12, 2025 USCDI V7 Suggestion review call

Steering Committee:

• Aug 20, 2025

Adjourned

12:55  PM EDT