2026-04-29 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box - regrets

primary

alternate

Epic

Dan Rutz

primary

alternate

Biomerieux

Xavier Gansel

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

primary

UT Southwestern Medical Center

Hung Luu

primary

UNMC

Scott Campbell

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

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

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

• SHIELD flyer by eVote needs more votes

• FDA leadership powerpoint update was submitted as reviewed, despite not having enough votes, since it was due

• eVote for Charter updates needs more votes

• NLM and FDA participation:

  • John Snyder is asking about decision for NLM

  • Reached out to contact for FDA Collaborative Community without an answer, so will now reach out to lead in OHT7

Review SHIELD WG Deliverables and Milestone Grid

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

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

Sep 19-25th HL7 is at Marriott in Rockville - in person meeting for SHIELD members? Potentially another DC area site.

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 still needs to ask OO if WG wants to sponsor 1 quarter for SHIELD meeting - would be good to have the days that work best

or could we use the connectathon days = Saturday or Sunday - would have to ask HL7

would be good to have FDA re-engagement

Should this be just Steering Committee or all of SHIELD?

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 Notes

Review on LIDR call work and next steps (2026-04-07 LIDR Meeting Notes ) - 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

Re-invite Serge for discussion

Discussion today:

• LIDR work:

  • include the Auto-Diff in the CBC LIVD and include the LOINC for the manual Diff, so that all is covered (and provide guidance on how to handle this)

    • for cell ID in proficiency testing that will be different than in clinical practice

  • exclude POCT

  • for Lipid Panel:

    • there are 3 different formulas for LDL calculations, so should include all 3, might need new LOINCs for that

  • limit to these test for now, since we need funding to support creation of this work

• Vision document:

  • in bottom of the document: green text has been moved to the draft content higher up

  • PAMA impact: expand labs that are participating and reduce reimbursement for labs

    • https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule/clfs-pama-reporting-resources

    • AMP and CAP support retracting of PAMA:

      • https://www.amp.org/advocacy/advocacy-resources/coverage-and-reimbursement/pama/

      • https://www.amp.org/advocacy/take-action/#/

      • CAP letter

      • AMP letter

  • Need to get funding model clear: IVD data hub collects fees for use

    • which can go to the labs providing the data

    • be used to curate LIDR content

  • Labs providing data to IVD datahub, MUST be following LIDR encoding - could be part of proficiency testing

  • need to reach out to get better idea of what pharma needs for monitoring - though not ideal to limit to that, but that is where the money is

  • What exactly is the level of detail real world data needs to have to be useful to IVD vendor to expand use (maybe to new sample type - just the tyoe, or also detail about how colected, containers etc) - Michael said he might be able to look if he can find more details

Next calls

All SHIELD Calls

• Jun 9, 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 20, 2026overlaps with HL7 WGM - Riki also out May 27, 2026, so will meet May 13, 2026

Call adjourned

1:00 PM ET

Ideas for the longevity of SHIELD Community and work

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)