2025-12-03 Steering Committee Meeting Notes

2025-12-03 Steering Committee Meeting Notes

Date

Dec 3, 2025

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 - regrets

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 - regrets

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

 

Jim Case - regrets

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

ADLM

Li Zha

primary

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

Victoria Derbyshire

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 18 named members (1 open slot), 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

12:10 PM ET - no quorum

Conferences/Webinars

No updates

Next calls

 

All SHIELD Calls

  • Dec 16, 2025

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:

Dec 17, 2025

CDC Forum Call in January 2026 date TBD 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 call in July

#3 Looking for Co-Chair for Vocab and Standards WG - Scott said he will help - YEAH!!!

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)

Next steps:

  • Folks to review the ASTP/ONC Lab report to create a vision 2030 - 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

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

Look for eVote shortly

Standards WG Vocab Follow up

  • Continue LRI Review Summary Document

    • On prior calls we discussed #1, #2, #4, #5, #6, #7, #8 and #15

  • Any answer about access to COSMOS data? - Update from Raj and Hung on what they found - neither of them are on - next time

  • Collect qualtitative result values from Labcorp, ARUP and Quest - no update today, but got commitment to get form several folks

Discussion today:

#3 - is just a statement

#9 - thre may be reason to have free text - when you want patient’s words, vs more formal codifying for summarizing

work with the Lab community what should be free, discrete vs discrete coded

#10 & 11 - should provide SCT with the recommendations, this is not for LRI specifically - but when / if hte speicmne CMT cannot be using the FHIR concpetmap resource, we may have the push to get SCT to work on this in their Quality improvement initiative (Jim Case)

#12 is just an overall statement

#13 - related to #9 - is workflow issue and implementation problem - need to have a community to work on this and then create that guidance - we did the EHR-S Funcitonal requirements for LRI - but that was problematic; in general the EHR-WG might be the right place, but not currently the right people; should this be created by ACLA or CAP, AMP or other professional organization? Example: CAP synoptic reporting structures

Robyn and Scott will brainstorm on next steps. LabMCoP could be an option for convening

#14 - also applies to LIS vendors - same as #13 and #9

#15 - mapping to LOINC, when some LOINCs are prescribed by CMS or HEDIS; roll up using the LOINC Ontology should be easier to deal with that - also LIDR is supposed to help there, too

need to decide on the preferred model and provide conversion tools between the different models

pragmatic implementation is often the culprit

PIQI framework effort is aiming to give you a quality report on your data to evaluate your implemantation to help folks address that

Next Steps:

Think about how to distill this document and what to do with it for next call

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

From Chat:

Missed taking screenshots - but I don;t recall seeing any links or importnat messages, that are not also captured in notes above - sorry

 

Action items

Robyn and Scott will brainstorm on next steps for creating guidance dovument 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 (Carmen?), Quest (Riki), SonicHealth (Eric)

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