2025-01-13 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc. - OPEN?

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 - regrets

primary

OPEN

OPEN

primary

Sonic Healthcare

Eric Crugnale - regrets

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

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 - regrets

alternate

NLM

 John Snyder

primary

alternate

FDA

 Keith Campbell

primary

Victoria Derbyshire - will join late

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).

Open Meeting

 1:05 PM ET - no quorum

Steering Committee Membership and Officer Roles

• These slots are potentially open:

  • 1 Vendor (Labgnostic has not been participating)

  • 2 Healthcare Provider (Nirmala resigned, Craig has not been participating on calls - got new contact at Quest)

  • 1 Patient Advocate (Stacy hasn’t been able to participate)

  • Prefer we ask for interest in the positions, so that we keep the folks on the “list” and get their input directly

• Chair and Vice Chair terms expire 3/14/2025, so need to hold elections

  • what do we do if we don't get nominations?

    • maybe switch positions of existing SC members

    • ask on ALL SHIELD call for self-nominations to the SC

    • ask the professional organization members to distribute further than SHIELD list for interest in participation in general

• Reach out to new ASTP/ONC Chief Data Officer if they are interested

  • should cover the 4 agencies CDC/FDA/CMS/ASTP

  • Riki to reach out to brief this person on SHIELD

Conferences

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

ISA 2025 reference edition has been published

https://www.healthit.gov/isp/sites/isp/files/2025-01/ISA-Reference-Jan-2025.html

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

Report of SHIELD achievements for 2024

4 active SHIELD Working Groups plus the Steering Committee

Total of 104 calls held in 2024 which include:

• 14 ALL SHIELD Community calls

• 9 Special Topic calls

• 62 Working group calls (32 LIDR+7 standards+17 comms+6 IVD)

• 19 Steering Committee calls

Presentations

• SHIELD members at LOINC 2023 and API 2024;

• FDA sponsored presentations at LOINC 2024, SNOMED CT 2024 and ASTP 2024

• 2 presentation proposals submitted for 2025

Provided feedback on 2 federal regulation/initiatives in 2024: USCDI V5 and Proposed HTI-2 Rule

List of the speakers on the Special Topics calls in 2024:

• Synensys and MIT - Report on Systems-theoretic Process Analysis of data Qulaity in the Lab Data Exchange space

• Pam Banning (Solventum)- Naming Options for Lab Tests within the LOINC terminology

• Karim Nashar (NHS)- State of Interoperability in the UK

• Judith Gillis (Amsterdam University Medical Center) - Comparability of lab results - Experiences in the Netherlands

• Nancy Cornish (CDC) - Specimen Cross-Mapping-Table

• Dr. James Crawford (Northwell) - Real World Data on COVID-19

• Scott Campbell (University of Nebraska) - SNOMED CT Encoded Cancer Synoptic Reports

• Giorgio Cangioli - FHIR Lab Report Impelementaiton Guide from HL7 Europe

• Charlie Harpe (Clinical Architecture) - LOINC Mapping Experiences

Several members of SHIELD are supporting HITECH and Sequoia Laboratory Data Interoperability Implementation Guide

5 articles referencing SHIELD work, which are linked to from our website SHIELD Coordination

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 7, 2025

• IVD Data Hub

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

• Standards Updates and Vocabulary Working Group

  • Still only 1 Co-Chair - meeting with 2 potential new folks that might help with leadership (Steven Emrick and Julia Skapic)

• Communications and Branding Working Group

  • SHIELD Membership Survey was approved by email vote to be sent out

  • Set up this linked-in page: https://www.linkedin.com/groups/13141575/

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:

• January 14^th - canceled

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

• March 11^th

Steering Committee:

• January 27th

Adjourned

 1:34 PM ET