2025-08-20 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

Roche

Nick Decker

primary

Roche

Open

alternate

Healthcare Provider

Indiana University/Indiana University Health/Association for Molecular Pathology

Mehdi Nassiri, MD

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 - regrets

primary

Former Quest Diagnostics

Collom, Craig D

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

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

12:09 PM 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

Conferences/Webinars

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

  • Review the slides? Deadline date: Julia will work on getting them ready for next steering committee.

  • Reviewing the updated SHIELD handout next call, since Eric is OOO till Aug 25, 2025

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

  • review ineligible organization clause from https://myadlm.org/education/accredit-your-education-program/accent-guidelines#Sponsor

    • Definitions 

      • Ineligible company: An ineligible company is one whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

        • Question on whether it includes Health IT?

        • IVD manufacturers look to be included

        • Software vendors?

        •  

      • 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.

    • Question: Is anyone of the SHIELD members an ineligible company?

  • unsure when slides are due

Time critical things

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

  • See 2025-08-13 Topic #2 Call for notes of the first call, should continue discussions on ALL SHIELD call Aug 26, 2025

Discussion:

Focus on information you can collect

Specimen Condition Acceptability - is not currently collected in discrete form, sent in chartable comment after the result instead, unless it is for the entire order, though even there it is more often a chartable comment on a canceled order

Some IVD instruments report some of these conditions (hemolysis, jaundice etc) as results, could be numeric or semi-quant or ordinal

Request is for renaming to conditon, and then could add 2 more elements:

• acceptability criteria - though those are defined in each lab’s compendium and not exchanged in the patient specifc message - there is would show up as

• specimen reject reason or as test not performed reason

IS the mapping to SPM-24 directive. e.g. is that where it must live? For encoded values, yes - the problem is that V2 has OBR-SPM connection, so where a panel contains more than one specimen - in later versions of V2 an element was added to OBX to identify the applicable specimen

LIMS/LIS may not have a separate tables for the specimen condition at this time to provide mappings

in Epic - for order cancelation we do have a list of canned reason, also support free text on the EHR side. in beaker it will probalby go to redraw workflow instead

In V2 before addition of SPM, could not use reject reason even at the OBR level, in V2.5.1 can reject at OBR, but not individual test level - there is a FHIR Jira that addresses the ways in which tests can be not performed, which also applies to V2 (situaltionally) so we could mapp how we would approach this in V2 (the ticket is for FHIR approach) https://jira.hl7.org/browse/FHIR-51640

FYI

• HTI-4 was released Jul 31, 2025  https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-electronic-prescribing

  • Webinar recording: https://www.youtube.com/watch?v=V1f-mkORFG8

  • Follow up items???

• 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.

SHIELD Charter Updates / SC participation

Updated version is here: https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3503226881

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

Standards WG Vocab Follow up

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

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

Discuss:

Made comments in the other confluence page - discussed Item #2

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

Not discussed

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

Not discussed

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)

  • Working 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/ )

    • 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.

• Standards Updates and Vocabulary Working Group

  •  Next meeting Sept 25. Stan provided an overview of the new LOINC Order codes coming in August LOINC release. They tend to be methodless, and some are systemless (XXX,specimenless) and curated from result LOINCs.

• 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 - Not discussed

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

• 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

• Aug 26, 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

Steering Committee:

• Sep 3, 2025 - what about Sept Sep 17, 2025 is during WGM lunch - move = yes move to Sept 24th? (No Nick, but works better for hL7 attendees

Adjourned

12:  PM EDT