2025-10-14 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 - regrets

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 - regrets

primary

Sonic Healthcare

Eric Crugnale - regrets

primary

Former Quest Diagnostics

Collom, Craig D - regrets

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

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

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 (2 open slots), 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

Conferences/Webinars

• At LOINC conference not much knowledge about LIVD

  • Biomerieux has international downloads even though they do not have specific communications about this

• SNOMED CT Business meeting slides for Rob Hausam to present

  • will send these out for approval

• Reviewing the updated SHIELD handout

  • not having hierarchy is a feature, not a bug

    • challenge here really is too much pre-coordinated attributes define a term, which may or may not clash with information model in the repsective HIT-system

    • audience won't understand “pre-coordinated” - for them there are just too many similar looking codes to chose for a test

    • will update that bullet

  • Changed goal of 100% to >80%

  • Change Expectations to Ideal State

  • Add space between laboratory and data

  • add 's' to dicipline

• ADLM webinar slides about SHIELD is scheduled for October 22, 2025 12 - 1 PM ET https://docs.google.com/presentation/d/1U38x3kp3br3zpTHjV3BUc-BTrsbDR2TsC2LVaZHAG9s/edit?slide=id.g385da3d5db0_2_281#slide=id.g385da3d5db0_2_281

  • Have 50 minutes of presentation, 10 minutes for questions

  • need to address the Learning Goals in slide 2

  • copied ASCLS slides and added some from ASTP report

  • still a work in progress

  • looking for suggestions on where to cut

  • Shouldn’t spend too much time on UDI, IVD vendors are required to create and submit to FDA GUUID for all registered medical devices, but might be good to call out as a heads up, especially since we want them to provide LIVD files, which ideally include the UDI - Nick might send a suggested list of bullet points

• AMIA November 15 - 19 in Atlanta, GA https://amia.org/education-events/amia-2025-annual-symposium/call-participation was accepted

  • When will slides be available to review - @Julia Skapik?

Adjourned

1:00 PM ET