2026-08-05 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 - regrets

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

primary

Scott Campbell - will be late or miss

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

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

12:08 PM ET

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

• Do we want to comment on:

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

    • Has sections on AI - do we want to comment as SHIELD on the need for data standardization to allow AI models to be applicable across different organizations

  • FDA rule around re-interpretation of genomics results / what is a specimen

• https://www.federalregister.gov/documents/2026/07/16/2026-14327/medicare-and-medicaid-programs-cy-2027-payment-policies-under-the-physician-fee-schedule-and-other CMS RFI starts on page 298/719: X. Request for Information (RFI) on
  Duplicate Laboratory Testing, Imaging,
  and Result Sharing and Interoperability - feedback due by Sept 16, 2026 - will collect that here: https://docs.google.com/document/d/1HSzfc_zpuzMTiNYvwKOZOD_uXp1rVm-0DrA0gvLK0Os/edit?tab=t.0

• USCDI V7 has been published

• 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

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!!!

Vision 2030 work

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

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

Serge is available Aug 11, 2026, invite has been snet

Discussion today:

• Difference between LIVD anf LIDR need to be clear, we don;t want to have folks think that LIDR is “plug-and-play”:

  • LIDR has additional data points, not provided by the manufacturer

    • Mapping lab tests whose results are not produced by the instrument, but related to the test - for example calculation of timed tests

  • LIDR publication should only happen after review of the LOINC mapping for accuracy

  • LIDR datamodel broader than LIVD

• perceived reasons of IVD vendors for not sharing LIVD files publicly:

  • IP issues?

  • regulatory concerns that mapping to a LOINC with broader system than the approved sample types is interpreted as encouraging off-label use

• Could we get a federal agency (FDA or ONC) to put out an RFI to get formal comments on the barrier for publicly posting LIVD files / making that content publicly available?

• Could these be topics for CLIAC, when re-instared or HITECH Committees?

• Reviewing the CMS physician pay schedule, which includes an RFI on lab data ineroperability to address duplication of testing - maybe some of our points could be included in that feedback?

  • this seems to be written by folks who are not very familiar with lab workflows, so need to make sure we give the proper feedback here to avoid issues with patient care later!

  • lab data interoperability is bad, becasue labs are often thought of as the black box - they are not elevated and accessible as much as EHR-s, so one way is to raise more awareness of lab work and the importance of the data labs produce - oftern the labs are only seen as cost centers, because they don’t generate revenue

  • Commercial labs need to provide the data in like the client (physician) wants, so need to support a mulittude of formats, since none of the clients are standardized

• Could we sign SHIELD up as a member of the CMS Interoperability Pledge?

  • not sure that would work, but we coudl find out which SHIELD members have signed the pledge and reach out to them for more participation

Next steps:

Rearrange the solution points by feasibility (from an overarching perspective, not necessarily what SHIELD can do)

Review the CMS RFI to see, if any of the points we are making in this Vision 2030 statement can be included as responses to the RFI - we will take this on on on our NEXT SC Call on Aug 19, 2026 - so please read RFI and add your comments in-line in the google document (or as comments): https://docs.google.com/document/d/1HSzfc_zpuzMTiNYvwKOZOD_uXp1rVm-0DrA0gvLK0Os/edit?usp=sharing

Call adjourned

1:02 PM EDT

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?

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)