2026-04-01 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

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

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

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

primary

 OPEN

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

Keith Campbell

primary

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 (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

12:07 PM ET - quorum at 12:??

Steering Committee Membership

• Proposed Charter Updates to Article 3 Section 4 - January 2026Preview

  • approved

• Removal of term limits - missing 1 vote (from Craig, who is now no longer on the SC can I count him as abstain? - will include in the update, when approved and publish then

• proposed additional update about voting - to count votes as abstention, if not received by the vote due date

Next Step: Riki will write up the updated text for the charter and send for eVote - this will include the change to count no-responses as abstain.

Review SHIELD WG Deliverables and Milestone Grid

THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!!

Vocab And Standards WG next calls new days and time has been sent out and will start in April

HL7 WGM in Bethesda joint meeting with FDA and CMS or other participants that are in the area possible?

Sep 19-25th Marriott in Rockville - in person meeting for SHIELD members?

Consider if part of WG quarter or one-off

USCDI V7 draft published

• comments due by Apr 13, 2026

• USCDI Draft-V7 FeedbackPreview - eVote was sent Mar 27, 2026 - reviewing any comments/ discussion today

Discussion today:

• Performance time:

  • Comments on these elements:

    • Proposed new name: “Clinically Relevant Date/Time”

    • Proposed new definition: “Clinically relevant date and/or time a care activity is performed; for laboratory tests, this is the date/time the specimen is collected.”

  • Difference between in-vivo and in-vitro tests - need to decide if this is for the performance as it affects the patient, or if it is for the performance of the activity that produces the result - this group feels its the latter

  • for in vitro (lab) tests need these date/times:

    • specimen collection (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#p-493.1241(c)(6) )

    • specimen received in the lab (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#p-493.1242(b) )

    • result created (from instrument or technician)

    • results released

  • for in vivo need these date/times:

    • result created

    • result released

  • for the temporal clinical context need:

    • date/time about the state of the patient = biologically relevant?

  • We looked at the HL7 OO WG comments: https://isp.healthit.gov/taxonomy/term/2436/level-0

  • Remember that USCDI defines the floor for data elements that need to be exchanged across different use cases, not for capturing the data, however, if the data to be exchanged is not properly captured in the first place, then it is not available for exchange

• NOt currently covered in USCDI specifically are some of the required additional information on orders (AOEs) for example Date of last menstrual period for Pap Smear (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#p-493.1241(c)(7) )

• Device Type:

  • Comment is that calibrators SHOULD be included, as they can affect the result values, too

Next Step: Riki will send out email highlighting these discussions, need to see, if we can resolve this via email / asynchrounously, or if we need to find time for another call - the second SHIELD call is past the submission deadline, so not an option.

Call adjourned

1:04 PM EDT

Vision 2030 work

https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?tab=t.0#heading=h.yp9lsvo5yvsf

Follow up from last call - see minutes: 2026-03-18 Steering Committee Meeting NotesPreview

Discussion today:

Next calls

All SHIELD Calls

• Apr 28, 2026

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

Special Topic:

• May 12, 2026 - LOINC Updates

Steering Committee:

• Apr 15, 2026

Ideas for the longevity of SHIELD Community and workPreview

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

  • FDA Scientific Computing Board (SCB)

  • Compass group lab

• Next HTI rule (whenever it comes out)