2026-01-21 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

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

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 - regrets

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 -regrets

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ASTP/ONC

Sara Armson - regrets

primary

 OPEN

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

Keith Campbell?

primary

alternate

ADLM

Li Zha

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

12:09 PM ET - no quorum - Adjourn 12:54 PM ET

Steering Committee Membership

Votes to extend our terms through March 31, 2026 passed

Open

Review participation for 2025: https://docs.google.com/spreadsheets/d/1QwCPA5haECNxPNAcJ8EeLzkxKcjxiktstlSJl3KpBOE/edit?gid=218103267#gid=218103267

Plan on nominating everyone for second term, UNLESS we have already heard from folks who cannot commit for 3 more years (Craig Collom, Nick as representative for Roche)- Andrea motions, Eric seconds: discussion: we can nominate and need to then hear back if they can commit and their organization supports them being the representative, abstain: 0, against: 0, in favor: 8 - will follow up with eVote to complete quorum

Review participation spreadsheet - almost all are >50%, several between 50 - 75%, do we want to decrease the participation requirement to 60% - yes, make that a change proposal for the Charter - see: Proposed Charter Updates to Article 3 Section 4 - January 2026Preview

Other topics / updates to the Charter?

• How to stagger terms?

  • Do we assign shorter terms for 2nd term for some of the members:

    • pick half of each stakeholder category in numbers and make term 2 years

    • volunteer for shorter term, and/or make OPEN positions shorter

• How to align with officer duties, which are 2 year terms?

  • not needed

• How to do the lot drawing to re-vote between highest 2 candidates?

  • there are apps for that, but what if not both candidates are in the room using an electronic tool for example https://onlinetoolz.net/draw-lots#t=candidate%201%0Acandidate%202

    • Have the chair draw for each stakeholder group

    • Hold this election on the ALL SHIELD call

    • this level of detial is not needed in the charter though

• How do we ensure the longevity of this work - longer term - what does it take to keep this viable?

  • if we need to bring funding into the mix, that needs time

To Do:

Write email about nominations, 2 year term and include consdierations for the longevity of this work and request thoughts from folks

Vision 2030 work

What the message to HHS Leadership should/could be - review the Lab Report and find those things where we can connect the dots to get traction on standards adoption: https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?tab=t.0#heading=h.yp9lsvo5yvsf

Discussion today:

Please add any notes, thoughts directly nto the document, when you are working on this

Additional call is set up for Tuesday Janaury 27, 2026 12:30 - 1:30 PM ETto consolidate thoughts

If we need more time after the Feb 4th call, could use the Feb 10th Special topic call to finish up

Next steps:

• Set up the additional call for Jan 27, 2026 12:30 - 1:30 PM ET

• invite Serge to the SC meeting on Feb 18, 2026

Conferences/Webinars/Annoucements of Interest

HTI-2 NPRM Withdrawn: https://www.federalregister.gov/documents/2025/12/29/2025-23890/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health - no way to comment on this one.

• Laboratory Related items:

  • USCDI. Adopt the United States Core Data for Interoperability (USCDI) standard v4 (45 CFR 170.213(c)); establish an expiration date for USCDI v3; and update certification criteria that cross-reference USCDI:

  • § 170.207(c)—Laboratory tests;

  • Computerized Provider Order Entry—Laboratory Criterion. Update the “computerized provider order entry—laboratory” certification criterion (§ 170.315(a)(2)) to require a Health IT Module to enable a user to create and transmit laboratory orders electronically according to the standard proposed in § 170.205(g)(2) (HL7® Laboratory Order Interface (LOI) Implementation Guide (IG)); and require technology to receive and validate laboratory results according to the standard proposed in § 170.205(g)(3) (HL7® Laboratory Results Interface (LRI) IG).

Next calls

All SHIELD Calls

• Feb 24, 2026

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

Special Topic:

Feb 10, 2026 - Any Topic?

Mar 10, 2026 - Any Topic, maybe update from ASTP Annual Meeting?

Steering Committee:

Jan 27, 2026 - 12:30 - 1:30 - special call to work on Vision 2030 document

Feb 4, 2026

CDC Forum Call on Mar 3, 2026 12 - 1 PM ET with Topic: UDI in HL7.

Review SHIELD WG Deliverables and Milestone Grid

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

Vocab And Standards WG next calls anf call information?

Placeholder to get back to later

• HTI-5 website

• 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 – work with Helena Sviglin

  • FDA Scientific Computing Board (SCB)

  • Compass group lab