2026-07-01 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

OPEN

OPEN

primary

OPEN

OPEN

alternate

Healthcare Provider

Quest Diagnostics, Seattle, WA

Mehdi Nassiri, MD - regrets

primary

University of Wisconsin-Madison

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA

primary

UT Southwestern Medical Center

Hung Luu

primary

 OPEN

OPEN

primary

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare / ACLA

Eric Crugnale

primary

Harvard

Li Zha

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case

primary

Monica Harry - regrets

alternate

Regenstrief Institute

Marjorie Rallins - regrets

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

Scott Campbell - regrets

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ONC

Sara Armson

primary

 OPEN

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

OPEN

primary

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 (1 open slot, future 3 openings), 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

Follow up items

• NLM and FDA participation:

  • John Snyder is asking about decision for NLM

  • Reached out to contacts for FDA Collaborative Community and lead in OHT7 - they are working on finding a resource

• CLIA in congress: https://www.congress.gov/bill/119th-congress/house-bill/8890/text?s=1&r=1&hl=clia

  • AMP is keeping an eye out

  • affects LDTs, mentions a centralized dB for those, so maybe could expand LIDR to piggy-back off that effort, if there is funding?

  • would be good to see, if this database could capture LOINC assignment (or encourage request for new codes, if mapping not possible)

  • a lot of discussion going on in the lab community

• ONC LEAP Grant announcement:

  • Area 3: includes a pilot for independent small labs to support LOINC coding or other interoperability approaches

    • should update language around replacing local codes to clarify that this should be mapping in addition, since unique ID is required for workflow triggering

  • Letter of intent was due yesterday

• https://healthit.gov/blog/standards/advancements-in-health-it-oncs-2026-approved-svap-standards/

  "Beginning August 29, 2026, Health IT developers participating in the ONC Health IT Certification Program may voluntarily use these approved standards in their Certified Health IT Modules. SVAP provides a pathway for developers to adopt newer standards versions without waiting for regulatory updates to certification requirements."

• USCDI V6 is named, which adds several new lab related data elements

• you can be certified to perviously SVAPed standards - this just adds to exiting certifications

• if you want to suggest improvements on USCDI elements submit that to the websites

• for translation of data elements into implementations review US Core specifications and attend HL7 Cross Group Calls = Thursdays 1 -2 PM ET =

SC Members

Scott Campbell now at CAP and will replace Raj as primary CAP representative, Kevin will be alternate - Riki requested email to that effect for records - still open

Updates to Codes for Outbreaks

• Hantavirus no longer emergency in US (new LOINCs are coming and the LIVD file should still be published) - SNOMED CT modeling ongoing

• Will work on Ebola LIVD later

• APHL is also researching process to coordinate the communication between the SDOs and outbreak response organizations for the future

Review SHIELD WG Deliverables and Milestone Grid

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

The Standards and Vocab WG first call was held on Tuesday, Jun 23, 2026 10-11 AM EDT - start out with once a month on the third Tuesday

HL7 WGM in Bethesda joint meeting with FDA, ONC and CMS or other participants that are in the area possible?

RSVP so far (not public, but we can review)

•Potential Agenda Items:

1.Short term interoperability goals/recommendations (aligned with Vision)

2.Top lab tests for national adoption

3.Blockers and what's needed to overcome

4.ONC presentation on their lab interoperability goals. (What they can share. areas of focus so SHIELD can align)

5.Presentation about SHIELD, interop challenges, needs to any congressional reps (education, conversation)

6.Conversation with FDA on need for discrete, searchable test details (510 K). Do they have details? Website issue? What would address? Emphasize need for PH among others (COVID, Hanta, Ebola, etc.)

7.Conversation with other agencies/entities on lab topics in their area? (e.g. CLIA, SDOs, NLM, Rachel Dunscombe from HL7?)

8.Conversation on IVD vendors on how to get LIVD maps from them (those not yet providing). Ideas, how to execute and by which entities/people, by when?

9. Longer term needs (Vision) discussion - specific semantic concept modeling

10.Next Steps Need to develop time blocks for agenda, Goals, Questions. Next Steps. Maybe 15 min presentation, 15 min Q&A, 15 min discussion 10 min Next Steps w point person and by when.

11. Invite congressional folks related to the CLIA LDT database?

Vision 2030 work

https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?tab=t.0#heading=h.yp9lsvo5yvsf

Follow up from last call when discussed see minutes: 2026-04-29 Steering Committee Meeting Notes

Need to find date to re-invite Serge - consider aiming for Aug 11, 2026, so we have some time to polish the text; we will use the Special Topic call on Jul 14, 2026 as working session

Discussion today:

We will polish the text on July 14th - please all check to make sure you have access to the gooledoc before the call

Next calls

All SHIELD Calls

• Jul 28, 2026

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

Special Topic:

• Jul 14, 2026 use this for Vison 2030 preparation and Aug 11, 2026 as option to meet with Serge (in addition to Aug 16, 2026)

Steering Committee:

• Jul 15, 2026

Call adjourned

1:?? PM ET

Ideas for the longevity of SHIELD Community and work

not discussed

Placeholder to get back to later

• Antimicrobial result reporting - CAP Informatics Commitee will request feedback from Standards and Vocab WG

  • Any updates from CAP?

• Other presentations to folks at FDA?

  • Data Standards Review Committee of the FDA

  • FDA Scientific Computing Board (SCB)

  • Compass group lab

• Next HTI rule (whenever it comes out)