2026-01-07 Steering Committee Meeting Notes

2026-01-07 Steering Committee Meeting Notes

Date

Jan 7, 2026

Attendees

(bolded names indicate attendance)

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

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

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 - regrets

primary

Christina Gallegos - regrets

alternate

Logica

 

Stan Huff

primary

 

alternate

CAP

 

Raj Dash - regrets

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

Agenda and Notes

Item

Notes

Item

Notes

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

 Li Zha attended as guest.

Open Meeting

12:10 PM ET Adjourn 1:02 PM ET

Steering Committee Membership

Vickie Derbyshire retired from FDA 12/19/2025

All of our terms expired Dec 20, 2025

eVote to extend the term of the current members to cover the missed 90 day announcement was sent on Dec 21, 2025 . As of 5Jan26, received 11 affirmative votes (100%) for the extension. 11 is quorum.

Announcement for nomination requests was sent to the ALL SHIELD distribution list on 12/19/2025, nomination period ends Feb 20, 2026, then vote should be on first Steering Committee call in April = Apr 1, 2026

Started reviewing SHIELD Charter on terms expiring for organizations (currently 2 consecutive 3 terms - understand how that works for individual members vs organizations). Also participation, and number of Steering Committee members from each stakeholder group. Question arose on whether all Steering Committee members are elgible for re-election for another 3 year term. Answer is yes. However, at the end of 2028, re-elected members will be termed out and need to have a year hiatus before being eligible to return to Steering Committee. It is possible there could be turnover of majority of Steering Committee members at that time. It’ll also be dependent on how many new folks join Steering Committee this year.

The participation Spreadsheet below indicates the term start and end dates in the far left columns for reference. Review participation for last 6 months: https://docs.google.com/spreadsheets/d/1QwCPA5haECNxPNAcJ8EeLzkxKcjxiktstlSJl3KpBOE/edit?gid=114687532#gid=114687532

 

Vacancies to be filled (as of 7Jan26)

  1. Industry (1)

  2. Health Professional (1)

  3. Patient Advocate (1)

Alignment of member terms with officer role terms.

Federal partners participation?

 

 

Conferences/Webinars/Annoucements of Interest

https://www.beckershospitalreview.com/healthcare-information-technology/ai/ai-begins-renewing-prescriptions-in-utah/ Stan mentioned Intermountain involved. Not enough physicians to take care of patients in Utah. Looking to reduce burden. Vendors tryign to automated straightforward renewals.

See Communications and Branding WG updates below. No conferences currently.

Next calls

 

All SHIELD Calls

  • Jan 27, 2026

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

Special Topic:

Jan 13, 2026 - Any Topic? No topics/speakers suggested today, so cancel.

Steering Committee:

Jan 21, 2026

CDC Forum Call in January 2026 would have been January 8th, so now looking for a date for Topic: UDI in HL7. Jasmine indicated that the next CDC Forum will likely be in March.

 

 

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

 

Next steps:

  • Aim for Jan 21, 2026 to discuss the outline

  • invite Serge to a SC meeting - aim for either Feb 4, 2026 or Feb 18, 2026 No confirmation yet on dates.

Review SHIELD WG Deliverables and Milestone Grid

THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!! - will review again in January

Standards WG Vocab Follow up

  • (Julia) Plan to have a meeting at the end of January. Will be last Tuesday in January. Plan for calls.

    • Working on same projects

      • orders

      • complex lab results: genetics, complex panel lab result. Focus on those that are unstructured.

      • Create documentation

  • Discussion:

    • Recognition that there are no FHIR Laboratory IGs (LRI, LOI, ELR equivalents) under development, but different calls working on parts of laboratory workflow/data needs that would be needed by these IGs. COW is working on ordering needs, grouping call is working on how to group lab results in panels and complex result reporting in FHIR Diagnostic Report, Specimen calls are working on transport and container needs.

    • Dan mentioned NAACCR looking to add cancer data needs to LRI v2. Andrea highlighted the FHIR Cancer Pathology IG work, but is still work in progress not ready for daily reporting. She mentioned US Core v8 lab profiles updated to have the test name (test performed/to be performed in CLIA language) as must support in FHIR. However, many IGs have not yet adopted this version/functionality in FHIR.

    • Sonic is working on V2 messaging via APHL AIMs platform to send to cancer registry reporting. Another mentioned that APHL AIMs is not free for labs. It may vary depending on the type of data too. V2 may be easier to implement for cancer registry reporting as functionality in LIS exists for other V2 messaging (ELR, LRI, LOI), in many cases.

  • Completed LRI Review Summary Document

  • Any answer about access to COSMOS data - variety of result data? - Update from Raj and Hung or Scott? on what they found out

    • OHDSI (OMOP data) or PCOR-net or I2B2 also are Common Data Models(CDMs).

  • Collect qualitative result values:

Discussion for today: How to distill this document and what to do with it

  • Pull out recommendations and feed back to LRI?

  • look if any recommendations could be used in the vision 2030 letter

Communications and Branding WG Updates: Looking at presentations for 2026. Missed some windows. Did have good presentations in 2025. Will try to monitor better.

IVD Data Hub WG Updates: Continued to be on pause. Looking at efforts, who’s driving, partnerships.

LIDR WG Updates : White paper completed. Looking to draft journal article.

HTI-5: HTI-5 Rulemaking from ONC emerged December 22, 2025. Public Comments due by Feb 27, 2026. If anything SHIELD should comment upon, please reach out ASAP. Otherwise, SHIELD may pass on commenting (since not much impacting laboratory data) on this rule. Folks are encouraged to review the video and other materials on the ONC website.

 

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 – work with Helena Sviglin

    • FDA Scientific Computing Board (SCB)

    • Compass group lab

From Chat:

Integrated above, but includes AI prescribing in Utah, HTI-5 comment date, and CDC Forum informatoin.

Action items

Robyn and Scott will brainstorm on next steps for creating guidance document around when to use free text vs discrete data vs coded discrete data and other implementation guidance around coding
Riki to send out eVote on LIDR White Paper => All review and vote!
All review the ASTP/ONC Lab Data Interop report and pull out items that SHIELD can support / identify the order of steps needed to improve adoption
Gather lists of qualitative results from LabCorp (Carmen) ARUP (Jenna), SonicHealth (Eric)
Riki to create the googlesheet for Vision 2030 statement and share
Riki to create pdf and upoad to LIDR Whitepaper page for easy download
Riki to lock all SHIELD pages that are over 1 month old and not currently being used for collaboration

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