2025-12-17 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

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 - regrets

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 - regrets

primary

alternate

AMP

Robyn Temple

primary

alternate

ADLM

Li Zha

primary

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

Victoria Derbyshire

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 18 named members (1 open slot), so 2/3 = 12 is quorum (excluding chair and government members).

# of voting member per charter: 13 - 21

# of non-voting members per charter: 7

Open Meeting

12:10 PM ET - no quorum

Conferences/Webinars

not discussed

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?

Steering Committee:

Jan 7, 2026 - Riki + Christina not available, but Andrea can chair and Jan 21, 2026

CDC Forum Call in January 2026 would have been January 8th, so now looking for a date in February Topic: UDI in HL7

Membership

#1 Waiting for official NLM representative since John Snyders departure from NLM - Raja Cholan is still working on getting a new representatives, asked to keep informed on any feedback that is NLM related

#2 Announced the open Steering Committee slots on the ALL SHIELD calls since July

Serge’s proposals for raising awareness

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 (given a vision for 2030)

Reviewed the email Serge sent to Eric and Riki - will incorporate points from it in the brainstorming document

Note that CAP is working on Performance Monitoring Workflow IHE profile, which will include checking data quality created as part of proficiency testing

Next steps:

• Folks to review the ASTP/ONC Lab report to create a vision 2030 - aim for Jan 21, 2026 to discuss the outline

  • How do we want to organize this - use a googlesheet to collect the focus points and prep for the call

• invite Serge to a SC meeting - aim for either Feb 4, 2026 or Feb 18, 2026

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

LIDR White Paper

eVote was approved - so we will now lock the page and folks can use it as reference in articles

Suggestion was to create a pdf that could be shared - will be uploaded to the page so folks can download just the text, not everything that is on the page

Standards WG Vocab Follow up

• Completed https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3347447812

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

  • Reach out to OHDSI (OMOP data) or PCOR-net or I2B2 data?

• Collect qualtitative result values:

  • recevied from Quest

  • from Labcorp?

  • from ARUP?

  • also FHIR IPS has value sets from SNOMED CT GPS set:

    • https://hl7.org/fhir/uv/ips/ValueSet-results-presence-absence-uv-ips.html

    • https://hl7.org/fhir/uv/ips/ValueSet-results-microorganism-uv-ips.html

    • https://hl7.org/fhir/uv/ips/ValueSet-results-pathology-uv-ips.html

    • https://hl7.org/fhir/uv/ips/ValueSet-results-blood-group-uv-ips.html

  • European Semantic Working Group also working on ordinal and sensitivity testing results

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

Placeholder to get back to later

• Antimicrobial result reporting - CAP Informatics Commitee will request feedback from Standards and Vocab WG

• 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