Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box - regrets

primary

alternate

Epic

Dan Rutz

primary

alternate

Biomerieux

Xavier Gansel - regrets

primary

alternate

Roche

Nick Decker

primary

Roche

Open

alternate

Healthcare Provider

Indiana University/Indiana University Health/Association for Molecular Pathology

Mehdi Nassiri, MD - regrets

primary

University of Wisconsin-Madison

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

primary

UT Southwestern Medical Center

Hung Luu - regrets

primary

UNMC

Scott Campbell

primary

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

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-regrets

alternate

HL7

Julia Skapik

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick - regrets

primary

Christina Gallegos

alternate

Logica

Stan Huff

primary

alternate

CAP

Raj Dash

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:?10PM ET

Membership

#1 Waiting for official NLM representative since John Snyders departure from NLM - Raja Cholan is still working on getting a new representatives, asked to keep informed on any feedback that is NLM related

#2 Announced the open Steering Committe slots on the ALL SHIELD call - so far no nominations - reach out to ADLM - who will do that?

Conferences/Webinars

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

  • When will slides be available to review?

  • Reviewing the updated SHIELD handout?

• ADLM webinar about SHIELD is scheduled for October 22, 2025 12 - 1 PM ET

  • Answer about ineligible companies: To put it plainly, ACCENT’s definition of an ineligible company is any company whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. 

    Calling out a few examples from SHIELD’s list, Biomerieux, Roche, Abbott, would all be defined as ineligible companies. Meanwhile, educational institutions (Upenn, UT Southwestern, etc.), reference laboratories (ARUP), and government agencies (CDS, FDA, etc.) are not ineligible companies.

    Overall, ACCENT has no concerns with faculty or planning committee members having financial relationships with ineligible companies participating in the activity. The only exception is if those individuals are employees or owners of those ineligible companies, we would just need attestation that their relationships will not bias their content or contributions.

    More details regarding ACCENT’s rules regarding financial relationships can be found on the ACCENT Guidelines webpage

    • Sponsors: Ineligible companies contributing money to the Activity Organizer that is used in support of planning and/or delivering the educational activity.

    • Supporters: Ineligible companies contributing in-kind resources to the Activity Organizer that is used in support of planning and/or delivering the educational activity.

    • Endorsers: Ineligible companies that agree to endorse the educational activity formally and publicly for the purpose of marketing and/or communicating the educational activity. An example might be an ineligible company that is acknowledged in the program documentation or promotions as an educational partner but does not fall into the Sponsors or Supporters definition above.

  • Next Steps:

  • Review Slides either Sept 24th or more likely Oct 15th call

Time critical things

• ​https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3453616246Open are due by ​Sep 29, 2025
  

  • See 2025-08-13 Topic #2 Call for notes of the first call, and made more updates on ALL SHIELD call ​Aug 26, 2025
    

  • Will need to vote to approve on Sept 24th SC or via e vote if not quorum

Discussion:

FYI

Anything new?

The LOINC Ontology v2 is expected to be released around September 21. register for the LOINC conference Oct 7-10 in Montreal.

​https://loinc.org/conference/montreal-2025/register/Open

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/2020966449

Have gotten some votes, Jim added comments and is requesting to slim down the White Paper - send it back to the LIDR WG. Reviewed on LIDR call.

Standards WG Vocab Follow up

Continue ​https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3347447812Open

Last call we discussed #1 and #15

Any answer about access to COSMOS data? Dan not on, so no answer here

Collect quantitative result values from as many vendors we can - what would be the best way to get this? In 2018 (or was it 2020) several vendors had lists; would be good to get a list so we can make sure SCT codes are available for those

Requested next Vocab call discuss SNOMED Container and additive requests.

Discuss:

Roadmap section updates in response to ONC comments on the SHIELD roadmap

Reviewing Updated Roadmap: https://aphlinformatics.atlassian.net/wiki/download/attachments/3214147628/DRAFT_UpdatedSHIELD_Community Roadmap_20250402.docx?api=v2

Changes are highlighted with markup addressing these ONC comments:

1. Aligning the roadmap scope to the mission scope

2. Addressing the concern that all standards need training and education

• Still need to review this one: Reviewed 2Jul25 see page 5 added text.

3. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap.  ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).

Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an example implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

(Action plan of which solutions would improve intereoperability. Why were these solutions chosen for the path forward. What is needed? How do you know this is the right path forward? Where’s the evidence this will work? )

For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption.

Discuss:

Review Working Groups progress

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

Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid

• Laboratory Interoperability Data Registry (LIDR) Working Group

  • Waiting for SC review of the LIDR White paper (see below)

  • Waiting for Deloitte on a pilot project with KOMET and Biomerieux

  • 4th Tuesday Cadence of meeting once a month

• IVD Data Hub

  • Exploring finding funding opportunities - current talks with Truveta (​https://www.truveta.com/Open )

    • No update since last time. Been holding with limited attendance. Looking to pilot use of their systems. Unclear what can be done without funding. Federal folks haven’t been able to participate. Nick will chat with some of the IVD folks on trying to recruit more folks.

    • Positive news to see if this can resume.

    • Question on when engagement from federal agencies will resume.

• Standards Updates and Vocabulary Working Group

  •  Next meeting Sept 25. Discussion the SNOMED Container terms.

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

  • Continuing to review survey results. Many great comments. Working through free text comments. Have slides prepared. Had to move meetings that overlap with Steering Committee.

  • Lab Orders. Australia is working FHIR based e request. Providers send orders to central repository, mapped to SNOMED CT for lab orders. Reach out to Eric for more information.

Placeholder to get back to later

• Request from e-XHealth project and HL7 Europe around remodeling the container hierarchy in SNOMED CT looking for input from laboratorians around some of the details

  • Update from Standards and Vocabulary WG

  • other topics around container:

    • model needs to allow for accommodating additives being added later vs being in applied by manufacturer

    • model needs to also allow for mapping to UDI (Medical device in USCDI) vs SNOMED CT

    • Timeline? They will be moving forward.

• ​https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltextOpen AMP paper - do we need to do something with this as the Steering Committee?

• Antimicrobial result reporting

  • Related work at HL7 Europe:
    

• ​https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltextOpen
  

• Other presentations to folks at FDA?

  • Data Standards Review Committee of the FDA – work with Helena Sviglin

  • FDA Scientific Computing Board (SCB)

  • Compass group lab

Next calls

All SHIELD Calls

• ​Sep 30, 2025

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

Special Topic:

• ​Sep 9, 2025 Sara’s presentation ASTP/ONC Updates

  • USCDI exchange capability. Certification Companion Guide.

    • https://www.healthit.gov/topic/certification-ehrs/onc-health-it-certification-program-test-method

    • https://www.healthit.gov/test-method/united-states-core-data-interoperability-uscdi-0

    • https://www.healthit.gov/test-method/application-access-all-data-request

  • Real world data reports on using FHIR for Laboratory Data

  • Laboratory needs without incentives/regulations (how to spur voluntary adoption)

Steering Committee:

• ​Sep 24, 2025(Riki to move invite from Sept 17th to 24th)

• October 1, 2024 Riki and Andrea both OOO

  • prefer to cancel, meet Tue Oct 14th (instead of Topic call), or Wed Oct 29th?

Adjourned

1:00PM EDT