2026-04-15 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 - rgrets

primary

alternate

OPEN

OPEN

primary

OPEN

OPEN

alternate

Healthcare Provider

Quest Diagnostics, Seattle, WA

Mehdi Nassiri, MD

primary

University of Wisconsin-Madison

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

primary

UT Southwestern Medical Center

Hung Luu

primary

UNMC

Scott Campbell- regrets

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 - regrets

primary

Monica Harry

alternate

Regenstrief Institute

Marjorie Rallins - regrets

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 - regrets

primary

alternate

CAP

Raj Dash - regrets

primary

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

Keith Campbell

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

12:07 PM ET - quorum at 12:??

Follow up items

• USCDI Draft-V7 FeedbackPreview was submitted

• eVote on Proposed Charter Updates Mar - April 2026Preview will come out later today

• Review Action Items below

• NLM and FDA participation:

  • John Snyder is asking about decision for NLM

  • What can we do about FDA?

    • Reach out to contact for FDA Collaborative Community first, if no answer email lead of the OHT7 division?

      • yes, reach out to FDA Collaborative Community contact first, then OHT7 leadership

      • could also reach out to Greg Pappas

Updates for FDA leadership

Request came in yesterday - reviewed the draft slides, will send out for eVote by EOD today.

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 should start in May - Julia will send the call invite - it will be either once a month on Tuesday or Wednesday at 11 AM ET; Riki will share the emails for the WG members

SHIELD Flyer Updates

Updated flyer version for review and then eVote

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

Sep 19-25th Marriott in Rockville - in person meeting for SHIELD members?

Consider if part of WG quarter (if OO can sponsor that; need to have permission for virtual participants) or one-off outside of HL7

Riki will ask OO if WG wants to sponsor 1 quarter for SHIELD meeting, if not that, then need to decide what other options we have

would be good to have FDA re-enagement

Vision 2030 work

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

Follow up from last call - see minutes: 2026-03-18 Steering Committee Meeting NotesPreview

Review on LIDR call work and next steps (2026-04-07 LIDR Meeting NotesPreview ) - discuss boundaries (exclude POCT?) and pick the tests to focus on besides the BMP, CBC (do we want to add Auto-Diff?), Lipid, SARSCoV-2) - collect any blocking issues to implementation for some of the proposed test types

Collect input from IVD vendors about the barriers to LIVD creation

Discussion today:

Robyn suggested to review nonwaived regulated analytes list to see if all are confirmed as included / on the list, so we added a column to double check against that list, too (see PT_Analysis tab)

review and data collation for the IVD test implementation will take some time, but is pre-requisite for having numbers to include in the vision statement doc

Let’s focus on the verbiage for the high level statement - can point out that a follow up document with implementation suggestions will follow

For next call = Apr 29, 2026 please re-familiarize yourself with the googledoc, so we can draft some more content and re-invite Serge to an upcoming call

Next calls

All SHIELD Calls

• Apr 28, 2026

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

Special Topic:

• May 12, 2026 - LOINC Updates

Steering Committee:

• May 6, 2026 - Riki and Andrea out - move to Apr 29, 2026!

• May 20, 2026overlaps with HL7 WGM - Riki also out May 27, 2026 - will decide on the next call

Call adjourned

12:53 PM ET

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)