2025-03-10 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 - regrets

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 - regrets

primary

UNMC

Scott Campbell

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

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

Graphite Health

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

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

1:07 PM ET

Conferences

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

• Suggested panelists: Jenna Rychert, Julia Skapik, Pam Banning - others interested Steven Emrick, Marjorie Rallins

• • UDI not yet functionality in EHR-s to capture this yet

  • Focusing on pain points for data exchange and how SHIELD can help

    • meaning of tests be distinct, method type is important, impact on incorrect codification of lab tests results in EHR-s

  • Clinicians care about finding the right test to order, where to find the result and what the next step is for patient care

  • Focusing on how SHIELD helps improve usability of lab results for providers

  • HEDIS measure problems with LOINCs from reference labs - HEDIS MY 2025: What’s New, What’s Changed, What’s Retired - NCQA

    • so folks map to the incorrect LOINCs to get HEDIS credits, which is not what we want to see

  • Impact of Chlamydia testing if incorrect LOINC is used

    • ELR

    • eCR

    • HEDIS measures

    • Insurance reimbursements

    • data quality

  • Would be good to include a plug for UDI and why providers should care about it - and ask for it

  • Ask attendees on what are their pain points are - Andrea can share a list of questions used in other presentations

  • Title: Should the title be more about the problem rather than SHIELD?

    • Automating sharing of high quality lab data and how SHIELD can support the Adoption of Standards for Laboratory Data Interoperability and Usability

• Setting up confluence page for thoughts - will copy from there into word, to fullfill the AMIA formatting requirements =2025 AMIA Panel Proposal

LOINC 7-10 October in Montreal, Canada - proposals are open till 3/30 https://loinc.org/conference/montreal-2025/presentations/

ASCLS got accepted - waiting for exact date/time

ADLM got submitted - not accepted - Pam’s proposal on LOINC mapping has been accepted, so she might be able to “put in a plug” for SHIELD

Find New Meeting Time

https://www.when2meet.com/?29478083-E8yoY

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

  • no meeting since last SC call

• IVD Data Hub

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

    • Ongoing work with Truveta - waiting for their baseline assessment

• Standards Updates and Vocabulary Working Group

  • Getting baseline and setting up use cases to work on

  • We should remind them of Xavier’s requets for valueset work

• Communications and Branding Working Group

  • SHIELD Membership Survey summary

    • reviewing the comments for summarizing the free text comments

    • Kevin is taking the lead using Chat GPT for some help

    • Next meeting is this week

  • AMIA proposal for panel - due by 3/19: Proposed panel members: - see above topic

SHIELD Charter Updates as shared via email sent to SC members on - not discussed

Proposed Charter Updates Feb 2025 - Review and vote here to approve the updated chater as a whole and then get votes from any missing person via email

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

Review Items - not discussed

LIDR White Paper was open for SC review and comment until Feb 21, 2025 - Riki has not recieved any via email, however there are a few from LIDR WG members that we haven’t addressed - we could do that today and approve, or send back to LIDR and then approve later - thoughts?

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

Steering Committee Membership and Officer Roles

• Chair and Vice Chair terms

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

  • Nomination period expired 2/12/2025

  • Votes have to be held before expiration, so on 3/10/2025 call - Interest received from:

    • Chair:

      • Riki Merrick (5)

      • Andrea Pitkus (1)

    • Vice Chair:

      • Eric Crugnale (2)

      • Riki Merrick (1)

      • Andrea Pitkus (3)

We will finish the vote via email!

• 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 individual

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

• Composition of Steering Committee changes?

  • Expand by 2 members, which would make quorum 13 instead of the current 12

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:

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

All SHIELD Calls

• March 25^th

• April 22^nd

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

Special Topic:

• March 11^th canceled instead we’ll have

• March 25^th LOINC Ontology Presentation

• April 8^th Synensys Report update

• May 13^th that is during HL7 WGM, but that is in Madrid, Spain, so may not affect that many folks

Steering Committee:

• March 24^th

• Not scheduled after this - decide on new day/time:

  • old schedule April 1, April 15

  • new schedule April 7 and April 21 is Easter Monday

Adjourned

 ?? PM ET