2026-04-07 Steering Committee Meeting Notes

2026-04-07 Steering Committee Meeting Notes

Date

Apr 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- regrets

primary

 

 

alternate

Biomerieux

Xavier Gansel

primary

 

 

alternate

OPEN

OPEN

primary

OPEN

OPEN

alternate

Healthcare Provider

Quest Diagnostics, Seattle, WA

Mehdi Nassiri, MD - regrets

primary

University of Wisconsin-Madison

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

primary

UT Southwestern Medical Center

Hung Luu

primary

UNMC

Scott Campbell- regrets

primary

Longtime Lab Professional

Carmen Pugh - regrets

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 - 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

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

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

 

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

Open Meeting

12:04 PM ET - no quorum

USCDI V7 draft published

Discussion today:

  • Performance time:

    • Reviewing the purple text

    • in V3 had similar discussion and decided that in addition to the definition, you really need to identify for each use case what the clinically relevant time is, so should describe them all and then identify whihc appy for each use case

    • Performance date/time is important for

      • turn around time

      • understanding if lab results occured before procedure (normal kidney function test before CT with contrast)

      • re-evaluation of tissue for lung cancer mutations - specimen collection date/time provides the info on when the mutation was found in the patient, performance time, when it was detected in the sample, which can be many years later - both are important

      • also important for medico-legal

    • specimen received date/time is important

      • clinician not re-draw the sample

      • for prior auth / reimbursement

      • need to track the different labs in a multi-lab workflow (in combination with the receiving organization information)

    • May be we should provide all the important dates for (lab) tests need these date/times:

    • Decided to include the entire purple text with both choices to showcase the complexity

  • Device Type:

    • added “initially” to allow for future expansion

    • added controls to the not yet in focus devices

    • discussed that reagents are also consumables, so added other to hopefully clarify that don’t mean those, but rather well plates, containers, pipettes etc

    • made changes to text in red font

Call adjourned

12:55 PM EDT

From Chat:

Screenshot 2026-04-07 124506.png

 

Action items

For Vison 2030 identify the low hanging fruit and pick timelines and phased adoption goals
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 and provide a feasible timeline and phased milestone list
LIS vendor certification incentives (or IHE Connectathons and capability statements)
CAP proficiency testing pilot to include UDI in the interface and gather LOINCs for the tested platforms and review and update, where needed, then import that into LIDR and make public
Find high return PH/emergency preparedness use cases for PH pilot and LIDR population (we already have the crowdsourced LIVD file, maybe see, if we can’t get more active participation in filling it out)
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
Gather lists of qualitative results from LabCorp (Carmen) ARUP (Jenna), SonicHealth (Eric)

 

Quick decisions not requiring context or tracking

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