2025-04-02 Steering Commitee 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

Yue Jin

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

primary

UNMC

Scott Campbell - regrets

primary

OPEN

OPEN

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics - OPEN?

Collom, Craig D

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case - regrets

primary

Monica Harry - regrets

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

Graphite Health

Stan Huff - regrets

primary

alternate

CAP

Raj Dash - regrets

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ASTP/ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

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

1:08 PM ET, no quorum

Conferences/Time critical things

AMIA November 15 - 19 in Atlanta, GA AMIA 2025 Annual Symposium Call for Participation submitted proposal

ASCLS presentation is scheduled for June 11, 2025, 8 - 9 AM PT - slides are due to ASCLS by May 16th, so need SC vote for approval before then - assume via email the week of May 12 at the latest, if we can’t get it done on SC call May 6th

USCDI Draft-V6 Feedback

Riki drafted some language from several sources

SC discussed adding an overarching comment around the need for more detailed data modeling in USCDI to prevent differing interpretations of data elements by different implementers

Riki will send link to page out to ALL SHIELD group today - request review by COB Monday (4/7)

Riki will review any comments/ make adjustments

Riki will send out to SC for email vote - broken into votes for each comment due by EOD 4/13, so Riki can submit approved comments as offical SHIELD comments by deadline of 4/14

SHIELD Charter Updates as shared via email sent to SC members on

Proposed Charter Updates To Article Three - March 2025 - Review the updated Article Three of the Charter as a whole

Discuss:

#1 Comments submitted:

• Organizational representative comment:

  • we understand need to ensure folks are using the right “hat”, but we don't really want to be in the situation wehre we need to enforce it

  • Can we put the work on the member claiming to be representative (and also the burden of proof)

  • Change from:

    • assumed that representative of Organizational Members have that authorization

  • Change to:

    • it is the responsibility of the Organizational Member(s) to obtain authorization from their Organization to participate as a Steering Committee member

• Appeal Process Section:

  • Robyn points out that the body that decides to terminate should not be the same as the one that hears and decides the appeal - but we only have the Steering Committee at the moment.

  • Possible options - all require more changes to the charter:

    • Have the appeal be submitted to the Chair / Vice Chair, then create an ad hoc committee that will review the appeal from the general membership? If so how do we pick this group?

    • Create an Executive Committee that are the Chair / Vice Chair of Steering Committee and Chairs of the Working groups - they could be the first to decide on the termination, then the appeal goes to the full Steering Committee, or the other way around?

    • Make the termination a decision of the Chair and Vice Chair and then appeal to the SC?

    • Or as part of member responsibilities identify the maximum number of missed meetings / non-participation, then the Chair / Vice Chair just informs the member of the loss of membership rights?

      • proposed timeframe: 6 months or shorter?

      • is it just meetings or any communication or?

      • what if the absence is communicated ahead of time (for organizational members they have the option to appoint other representatives to take their place, but that doesn’t work for individuals)

#2 Note: Changes to the Charter require unanimous approval by the Steering Committee - we will have to revote, but will hold on that until we can have Robyn on a call to get her thoughts

Steering Committee Composition

New member for open Healthcare Provider slot:

Carmen Pugh (8)

Mark Ediger (5)

Other issues for discussion:

• Craig has not been participating on calls, is on today after Riki remembered she has a cell number and texted him - we will need to get an updated email address, as he does not check the one SHIELD has often

• 1 Patient Advocate (Stacy also resigned via email)

• Composition of Steering Committee changes?

  • Expand by 2 members, which would make quorum 13 instead of the current 12 (once open slots are filled)

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:

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.

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.

Discussion:

Review Items

- NOT DISCUSSED -

NOT DISCUSSED - LIDR White Paper open for SC review until April 7th and discuss on the SC call on April 16th

Electronic Health Records and Genomics AMP paper - do we need to do something with this as the Steering Committee?

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 figuring out what a pilot project would entail

• IVD Data Hub

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

    • Ongoing work with Truveta - waiting for their baseline assessment - call set for later this week

• Standards Updates and Vocabulary Working Group

  • New meeting time (once a month starting week of April 14)?

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

Placeholder to get back to later

- NOT DISCUSSED -

• Antimicrobial result reporting

  • Related work at HL7 Europe:

• Electronic Health Records and Genomics

• 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

- NOT DISCUSSED -

All SHIELD Calls

• April 22^nd

• May 27^th

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

Special Topic:

• April 8^th Synensys Report update

• May 13^th - NEED TOPIC

Steering Committee:

• April 16^th

• May 6^th - need to vote on ASCSL presentation

• May 20^th - Riki not available

Adjourned

 1:02 PM ET