2026-07-15 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

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

 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 - regrets

primary

Scott Campbell

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) - regrets

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

OPEN

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

12:09 PM ET - no quorum

Follow up items

• NLM and FDA participation:

  • John Snyder is asking about decision for NLM

  • Reached out to contacts for FDA Collaborative Community and lead in OHT7 - they are working on finding a resource

• HTI-5 expected in August

• HTI-6 expected in November

• FDA statement: Genomic results are “not” the same as lab test results - re-analyzing the sample genomics result against a NEW VERSION of the library

• CMS rule: https://www.federalregister.gov/public-inspection/2026-14327/medicare-and-medicaid-programs-calendar-year-2027-payment-policies-under-the-physician-fee-schedule

• CMS RFI: Federal Register :: Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations - comments due by Sep 14, 2026

  • repeat testing

  • differentiating re-interpretation of existing result values on specimen from the initial result creation

• 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

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

Updates to Codes for Outbreaks

• Hantavirus LIVD file should come out soon

• Will work on Ebola LIVD later

• APHL is also researching process to coordinate the communication between the SDOs and outbreak response organizations for the future

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!!!

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

Updated spreadsheet:

realized that Monday is Yom Kippur, so we shoud not plan a meeting then. APHL time options are 8:00 AM - 5:30 PM, for Friday would have to be at APHL; for Thursday afternoon, I’d have to double-check with MaryAnn.

Stan prefers Wed at HL7 - he was the only one with a preference, so Riki will confirm with MaryAnn and then we will send out the calendar hold

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?

Vision 2030 work

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

Follow up from last call when discussed see minutes: 2026-04-29 Steering Committee Meeting Notes

Serge is available Aug 11, 2026,

Discussion today:

wordsmithed in document directly, added the clinical burden back in, making sure we state that SHIELD is unfunded and cannot do the LIDR development work without funds

Next steps:

• Add a section on who SHIELD is

• Add a section that explains the LIVD / LIDR relationship and that both are a means to the same goal, jsut require different funding approaches

• Might be good to list the steps to achieve our goals by feasibility / timing (short, middle, long-term) -

Next calls

All SHIELD Calls

• Jul 28, 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 5, 2026

Call adjourned

1:58 PM ET

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)