2026-08-19 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

primary

University of Wisconsin-Madison

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

primary

UT Southwestern Medical Center

Hung Luu - regrets

primary

 OPEN

OPEN

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

primary

Scott Campbell - will be late or miss

alternate

AMP

Robyn Temple - regrets

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

John Snyder (NLM)

primary

OPEN

alternate

FDA

Keith Campbell

primary

Daniel Canos (OCEA/CDRH)

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 15 named members (3 open slots), so 2/3 = 10 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

Follow up items

• NLM and FDA participation:

  • FDA re-engaging with SHIELD

    • device information made easier accessible

    • may need some HL7 work - expand Structured Product Labeling to cover some of the content that is in LIVD (and more that may not yet in LIVD)

      • identify issues that could happen, if we can include those in that same process or can the process be “split” or identify if we have fields that don’t have a lot of “churn”, but can be updated

    • LIDR WG has been looking for an easier way to get 510k information from FDA websites

    • Riki to request LIDR WG invites get forwarded to FDA

  • John is back as NLM representative - has been working on Quality initaitves to review additional extension content in the US: Crosswalk with US and Vet extension - promote 8 more concepts to the international edition; next is APHL and VA extensions to streamline SCT use

    • will need to reinstate the Vocab WG and wokr on the qualifier hierarchy terms

• Upcoming rules listing: https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST&currentPub=true&agencyCode=&showStage=active&agencyCd=0900&csrf_token=C0B6ACBF4D626D326F9722E8D1C8960644BAAEE8BF328F00B7FBFEFAF5B32D19D8D24859AA608E98CE0CD17F31F7FC0CC8FC

  • https://sam.gov/workspace/contract/opp/180c46c0287a4b4097106e0979f8c58f/view feedback due by Sep 25, 2026

• Review SC Participation - for Sep 16, 2026 call

• eVote about SHIELD ONC meeting outcome: 11 votes recevied - 2 abstain, 9 approve - need to make slides for review on Sep 2, 2026or latest Sep 16, 2026

• Raj Dash would like to present to 2026 Annual Conference – North Carolina HIMSS October 19-20 on SHIELD work in October - will also send those around between calls, or present on a future call

https://docs.google.com/document/d/1HSzfc_zpuzMTiNYvwKOZOD_uXp1rVm-0DrA0gvLK0Os/edit?tab=t.0

Working in document - could also do some work on ALL SHIELD call on Aug 25, 2026 need to have final votable content after SC call on Sep 2, 2026

Riki out Sep 10, 2026 to Sep 15, 2026, so vote needs to be complete no later than Sep 8, 2026, so that Riki and Andrea can do handover of content etc on Sep 9, 2026

Discussion Notes:

• Reviewed the USCDI+ / FHIR question first

• for the barriers and lever question we should review our vision 2030 statement to add in the low hanging fruit, wheer applicable and also pull out relevant barriers / suggested levers from ONC report in more detail

• incentives are needed for both LIS vendors AND the labs to implement standards - of course also the right timeframe (EHR-s are at least a decade ahead)

• for certificaiton ensure that in production systems are being certified, not just the underlying LIS

• Discussed need for support of post-coordination (hard for current systems, as tests are often not set up to be LOINC system or LOINC method agnostic; new LOINCs will supoprt value sets for both of these) - affects both the LIS (potentially need for support across many SCT hierarchies) and the labs (in terms of setting up tests with those things in mind

• would be good to have USCDI+ with much more data modeling - including realtionships between elements to support HIT system developers

Next Steps:

Please review the linked document and feel free to add your thoughts directly - we will pick this back up if we have time on the ALL SHIELD call, else next SC call

Call adjourned - below not discussed

1:02 PM EDT

Vision 2030 work

https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?usp=sharing

Follow up from meeting with Serge: 2026-08-11 Steering Committee Meeting Notes

Discussion today:

SHIELD F2F Sep 23, 2026 5:30 - 9:00 PM EDT

RSVP form: https://app.smartsheet.com/b/form/019fb2fc17007cde87fbce109db67277

Review Potential Agenda Items next copule of calls:

1.Short term interoperability goals/recommendations (aligned with Vision)

2.Top lab tests for national adoption

3.Blockers and what's needed to overcome

4.ONC presentation on their lab interoperability goals. (What they can share. areas of focus so SHIELD can align)

5.Presentation about SHIELD, interop challenges, needs to any congressional reps (education, conversation)

6.Conversation with FDA on need for discrete, searchable test details (510 K). Do they have details? Website issue? What would address? Emphasize need for PH among others (COVID, Hanta, Ebola, etc.)

7.Conversation with other agencies/entities on lab topics in their area? (e.g. CLIA, SDOs, NLM, Rachel Dunscombe from HL7?)

8.Conversation on IVD vendors on how to get LIVD maps from them (those not yet providing). Ideas, how to execute and by which entities/people, by when?

9. Longer term needs (Vision) discussion - specific semantic concept modeling

10.Next Steps Need to develop time blocks for agenda, Goals, Questions. Next Steps. Maybe 15 min presentation, 15 min Q&A, 15 min discussion 10 min Next Steps w point person and by when.

11. Invite congressional folks related to the CLIA LDT database?

SC Members

Scott Campbell now at CAP and will replace Raj as primary CAP representative, Kevin will be alternate - Riki requested email to that effect for records - still open

Review SHIELD WG Deliverables and Milestone Grid

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

The Standards and Vocab WG first call was held on Tuesday, Jun 23, 2026 10-11 AM EDT - start out with once a month on the third Tuesday - need call invite JULIA!!!

Next calls

All SHIELD Calls

• Aug 25, 2026

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

Special Topic:

• Aug 11, 2026 meet with Serge

Steering Committee:

• Aug 19, 2026

Ideas for the longevity of SHIELD Community and work

not discussed

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)