2026-03-18 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

primary

Roche

Open

alternate

Healthcare Provider

Quest Diagnostics, Seattle, WA

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 / ACLA

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case

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

alternate

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:?? PM ET - quorum at 12:08

Steering Committee Membership

• Proposed Charter Updates to Article 3 Section 4 - January 2026Preview

  • eVote outcome: missing 1 vote; Riki will follow up

• How do we get enough folks with shorter terms to allow staggering across the stakeholder groups - or should we consider a motion to remove term limits?

• Nominations so far on 2026 SC tab = review participation for 2025: https://docs.google.com/spreadsheets/d/1QwCPA5haECNxPNAcJ8EeLzkxKcjxiktstlSJl3KpBOE/edit?gid=218103267#gid=218103267

  • Labgnostic only had 5% participation over the last year - should we consider a vote to invoke the charter removal section?

  • Also Roche is not returning

• How are we going to do voting on the All SHIELD call?

  • We would request that each participant updates their zoom name to also indicate the stakeholder group they belong to.

  • Since we don’t have more nominations than slots, we were thinking we could approve the roster for each stakeholder group in one of these ways:

    #1 (probably the easiest): ask all members of the stakeholder group to approve the nominations and see, if anyone votes against

    #2 set up a ranking poll (e.g., https://strawpoll.com/xVg71barryr/results ) and ask every member of the stakeholder group to rank their candidates (though probably all would be approved anyways, since we have fewer or the exact number of open slots), so this may be overkill.

  • The charter does not mention any quorum requirements – so what happens if we only have representatives from one org, or just 1 person or even none for a given stakeholder group?

    • Can we open up the vote to all attendees or approve the full slate by a vote of all attendees?

Next steps:

EVote on removing term limits

EVote on letting all attendees vote on the full slate

USCDI V7 draft published

• comments due by Apr 13, 2026

• USCDI Draft-V7 FeedbackPreview

• will send out for eVote by Mar 25, 2026 so we can have discussion for any outstanding changes, in case a re-Vote is needed

For awareness

• LOINC 2.82 is out

  • https://loinc.org/news/loinc-version-2-82-release-highlights/

  • Release notes are now here: https://loinc.org/kb/loinc-release-notes/

  • recorded webinar: https://mailchi.mp/9485f299a7cb/video-recording-and-slides-from-the-loinc-webinar-are-now-available?e=2ef71d67b4

• CIRCLE | ARPA-H proposal

Vision 2030 work

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

Follow up from last call:

Define the goal, identify the low hanging fruit and timelines in which adoption of the existing building blocks can be achieved and provide a phased approach to slowly raise the bar (example 20% of tests with correclty coded LOINCS the first year 50% the next)

Phrase the need to support AI training and use in healthcare as another driver for standardization

Discussion today:

Creating a separate letter that could be shared with the current adminitration / congress that:

#1 Identifies the risks of using non-standard models to train AI models (example: the LOINC mapping work Andrea mentioned, where LOINC selection was based on the test name alone = having LIVD style data (even without a LOINC assignment) for each of the tests should have helped with mapping)

#2 Identifies USCDI data elements (V6 or higher) as the core data elements that should be standardized for lab data exchange - we could work with ASTP/ONC to ensure that USCDI+ lab data exchange use case is updated to reflect all required data elements that way

#3 similar to the table in the ASTP/ONC report provides the what cost, what benefit (T-shirt size level, not actual $$) each of the proposed steps would have adding specific timelines and phased milestones for each, so that there is an understanding of what needs one-time funding, what needs continous funding etc

#4 CAP proficiency testing is going electronic

• ask them to add support for UDI in those messages - that should encourage LIS vendors to build suport for it into their systems (that can then be leveraged for sending to EHR-s and PHS-s)

• ask them to collect the LOINCs used and then have those reviewed for accuracy by SHIELD, and provide feedback to the labs while at the same time start populating LIDR for the 10 most common tests

• CAP has a list of platforms for their type of proficiency tests - if we can get the LOINCs mapped for those, also good start for LIDR (then could use to showcase reduction in mapping burden?) - ask CAP for list of common tests

• Follow up email from Andrea listing the most common Lab LOINCs and questions: and and CAP PT list. Spreadsheet with Top 100 LOINCs tab, CAP PT Analytes tab, and tab mapping/combining the two.

• NOTE this FDA test access site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0

#5 PH / Emergency preparedness use cases are in the ASTP report - focus on some of those - doesn’t alwyas have to be direct funding support for all stakeholders - if you can reduce burden, that should also help

#6 Curating / gathering content for LIDR is very manual at this time - if we could showcase a process that makes that easier (maybe by linking new test submissions to FDA to LIDR (Keith surrent term for it: Device extension (DeX) in KOMET), or at minimum collecting all LIDR data elements when manufacturers ask for new LOINC codes)

Next calls

All SHIELD Calls

• Mar 24, 2026

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

Special Topic:

• Apr 7, 2026 - topic? - keep as option for USCDIV7 Draft feedback discussion, if needed

• May 12, 2026 - LOINC Updates

Steering Committee:

• Apr 1, 2026

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 and call information - Julia will send out a date/time and hope other Co-Chairs can attend

Ideas for the longevity of SHIELD Community and workPreview

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)