2025-02-10 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

NEED NEW

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

primary

OPEN

OPEN

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics - OPEN?

Collom, Craig D

primary

Patient Advocate

 OPEN?

Stacy Lange

individual

Standards Organization

SNOMED International

Jim Case

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

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 - regrets

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram - regrets

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 18 named members, so 2/3 = 12 (excluding chair and government members).

# of voting member per charter: 13 - 21

# of non-voting members per charter: 7

Open Meeting

 1:09 PM ET - no quorum

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

#1 Update how we add folks

• to the ALL SHIELD calls (Propose: Open to anyone reaching out to Chair/Vice-Chair to be added to the distribution list)

• to Working Groups Propose: Have to be an ALL SHIELD participant who should reach out (can be via email) to the Chair/Vice-Chair of the working group for membership.

• Resulting in these Charter Updates:

  • Section 6: Change “Nominations for Membership shall be made by a Member in writing addressed to the organization's Chair and Vice Chair.” to “Nominations for Membership in Workgroups or Steering Committee shall be made by a community participant in writing (can be via email) addressed to the respective group's Chair and/or Vice Chair.”

#2 Document switching between membership categories (Organizational vs Indivdual) for all SHIELD calls as far as identifying themselves in the attendance log of All SHIELD calls and when applying for positions to the Steering Committee or Workgroup membership Propose: If member desires to switch to between membership types, the request shall be made to SHIELD’s Chair and Vice Chair for 2/3 vote approval of a quorate Steering Committee. = ok to send in eVote

#3 Update member in good standing: Propose: A member is deemed to be in good standing if the member meets all ethical standards, policies, and procedures of the Organization.  Membership applies to Steering Committee members. = ok to send in eVote

#4 Add section for process for appeal after termination of membership (realistically this applies only to Steering Committee members and the main reason would be non-participation, thus impinging quorum): Propose: Appeal of Termination from Membership
An appeal of a termination shall be submitted to the Chair and Vice Chair, which would be presented to the Steering Committee for a hearing and final decision requiring a 2/3 vote approval of quorate Steering Committee. = ok to send in eVote

Note: Changes to the Charter require unanimous approval by the Steering Committee

Discussion on the call:

Agreed to the proposed text for items 2- 4.

Article 3 Section 4 should stay as is.

the membership text comes from organizations with membership fees, so some text might sound funny because of that

Do we have some form of gate-keeping - don;t want disruptions?

email chair / vice chair to get added to distribution list (but our confluence pages are open, so anyone can find out about us)

Should we make the LinkedIn account private? - we want as many folks as possible to participate

Membership requires participation, but do we want to spell out criteria? we need to be able to remove folks that are on the Steering Committee, since we have specific percentages per stakeholder groups, that are not active so they are not blocking work

• We have reached out to those who have not participated in calls and emails to find out, if they want to continue - have gotten different answers:

  • some yes, sorry personal life interfered, will attend now

  • some please excuse me going forward, personal life does not allow participation right now

  • and some gave no answer at all - the latter is who we will need to terminate and re-fill the slot(s)

For most of the folks on the SC (and on SHIELD) we didn't have the formal written designations from the orgnaizations at the begining, as most of us had been working on SHIELD on behalf of our organizations for years already, for newer members, or where representation has changed we did get emails

Does SC member also need to ask workgroup chair for addition to workgroup?

• in other orgs they wold be considered ex-officio members that don't have a vote (but we don’t hold formal votes in the workgroups), but might still be good to let workgroup chiar know they are interested, so that their qualifications can also be reviewed

• should have a way for newcomers to introduce themselves (on call or by sending resume or both

Need to be sure we can have officer elections before terms expire -focus on the Steering Committee membership changes, so we can fit the timeline

will ist nominees for the specific positions, as not everyon is interestedin either of the positions

Adjourned

2:03  PM ET = below NOT discussed

SHIELD membership requests from last call as shared via email sent to SC members on February 1, 2025

eVote outcome to approve these as new SHIELD Members:

• Steven Emrick

• Carmen Pugh former Labcorp and long time lab professional (as individual rather than a CDC representative)

• Mark Ediger as indivdual

• Natalee Agassi as representative for Oracle Cerner

• Matthew Allison as representative for Quest Diagnostics

Steering Committee Membership and Officer Roles

• These slots are potentially open:

  • 2 Healthcare Provider (Nirmala resigned end of December, Craig has not been participating on calls, would have to consider vote to terminate his SC participation, if we want to add more than one) = Have interest from these folks:

    • Jeffrey Smith from Kaiser Permanente

    • Carmen Pugh as individual

    • Mark Ediger as indivudal

  • 1 Patient Advocate (Stacy also resigned via email for now)

• Chair and Vice Chair terms

  • First of 2 allowed consecutive terms expires 3/14/2025

  • Nomination period expires 2/12/2025

  • Votes have to be held before expiration, so on 3/10/2025 call

  • Interest received from:

    • Chair:

      • Riki Merrick

      • Andrea Pitkus

    • Vice Chair:

      • Eric Crugnale

      • Riki Merrick

      • Andrea Pitkus

• Composition of Steering Committee changes

  • Expand by 2 members ?

Review Items

LIDR White Paper open for SC review and comment until Feb 21, 2025

Conferences

AMIA November 15 - 19 in Atlanta, GA - proposals are open till 3/19 AMIA 2025 Annual Symposium Call for Participation

LOINC 7-10 October in Montreal, Canada - proposals are open till 3/30 2025 LOINC Conference - Presentations – LOINC

ASCLS got accepted - waiting for exact date/time

ADLM got submitted - waiting for response

Notes from the FDA Collaborative Community Panel are here: FDA CDRH Collaborative Community Panel

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

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

  • LIDR White Paper open for SC review and comment until Feb 21, 2025

• IVD Data Hub

  • Exploring finding funding opportunities - current talks with Truveta (EHR data and analytics | Truveta )

• Standards Updates and Vocabulary Working Group

  • Have 2 new Co-chairs: Steven Emrick and Julia Skapic and Raj will keep supporting for transition

• Communications and Branding Working Group

  • SHIELD Membership Survey is open 2/3 - 2/14/2025

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

1. The roadmap mission section describes a broad vision of lab interoperability. However, the roadmap proposed solution is limited to the FDA use cases around In-vitro diagnostics (IVD) data, specifically populating the IVD data hub.  ONC suggests clearly describing the roadmap scope so the proposed solutions can be discussed within that context.

Updated language draft: Roadmap update: ONC Feedback

maybe add one more sentence or add a reference to the key consideration number for the IVD Datahub (Consideration 4) into these sentences. (change approved in principle.)

Discussion:

• Updated roadmap:

• Also need to remove the duplicate words “for the” in the last sentence

• Anything else needed on this one?

2. The roadmap identifies training and education needs around using LOINC as a barrier to interoperability. ONC suggests clarifying how the roadmap addresses this barrier. ONC recognizes that terminologies require training and education, and replacing LOINC with another standard will not address the barrier.

Update from Standards and Vocab WG about re-write of this section - from their March 18^th call (notes here, recording here)

1. Concepts around Healthcare IT (HIT) standards needs to be conveyed earlier in training for healthcare providers as use and application of standards in vended applications is the major gap.

2. Decision making to use Health IT standards are less likely left up to IT analysts as they mainly follow the requirements and then they generally use vendor supplied implementation guidance. However, a vendor may not support functionality for standards or only partially support.

3. Regulatory requirements (such as CLIA) may pose a hurdle to implementation of data standards.

4. Implementation guidance is often not well read. Training resources may not be well publicized or readily available. Perhaps conformance testing tools need to be made more widely available?

5. What might be helpful is to look at standards implementation from a data lifecycle standpoint across all users (end to end across ecosystem), rather than just training on a single standard for a single use case.

6. Last paragraph on page 4 of the road map final version could be augmented with these points.

Discussion:

• Need to find the exact space for these points, too

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.

Antimicrobial result reporting

Placeholder to get back to later

Related work at HL7 Europe:

Next calls

All SHIELD Calls

• January 21^st

• February 25^th (Andrea to host - Christina to support)

• March 25^th

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

Special Topic:

• February 11^th - Update from ONC’s Annual Meeting / Enhancing Laboratory Interoperability: Insights and a Path Forward Panel??

• March 11^th - Synensis Report update

Steering Committee:

• February 24th - Andrea Chairing