2024-12-03 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

NEW: Scott Vardy

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

primary

UNMC

Scott Campbell

primary

Tufts Medical Center

Nanguneri Nirmala

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

Stacy Lange

individual

Standards Organization

SNOMED International

Jim Case

primary

Monica Harry - regrets

alternate

Regenstrief Institute

Marjorie Rallins

primary

Eza Hafeza

alternate

HL7

Julia Skapik - regrets

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick

primary

NEW: 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

ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

alternate

NLM - regrets

 John Snyder

primary

alternate

FDA

 Keith Campbell - regrets

primary

 Victoria Derbyshire - regrets

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

Open Meeting

 12:10 PM ET, no quorum reached

Reminder of open action items / outcome of action items

• Participation in FDA’s CDRH’s Collaborative Community Panel on December 17 - all on this call approved

• Sending of SHIELD membership survey - we will do this in January

• Doodle for new timeslot

Collaborative Community Panel Presentation December 17, 2024 3:50 - 4:20 P

Review proposed answers to the questions

Content for Collaborative Community website

Received content request from FDA for Collaborative Community website: https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together

Ideas to highlight:

• 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

• 4 of 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

• 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

Conferences

ASCLS got submitted - waiting for response

• asked if we could do 60 minutes with more education on LOINC / SNOMED CT, fingers crossed!

ADLM got submitted - waiting for response

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

  • Draft of the LIDR White Paper is close enough to ask the SC members to review and add their comments: LIDR White Paper

• IVD Data Hub

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

• Standards Updates and Vocabulary Working Group

  • Still only 1 Co-Chair

• Communications and Branding Working Group

  • SHIELD Membership Survey waiting for SC votes!

Administrative things

Review SC Composition, terms and requirements for re-voting:

• Representative first 3 year terms expire 12/20/2025

• Chair and Vice Chair 2 year terms expire 3/14/2025

  • 90 days would be 12/14/2024 for call for nominations for Chair and Vice-Chair, so folks, start thinking about who might want to take the reins

  • email Andrea and Riki with any nominations

  • 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 participaiton in general

• Steering Committee attendance review and proposed members to be replaced due to non-attendance / participation:

  • will share via email

• Doodle Poll outcome: Best time for most folks is still TBD

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

• December 17^th

• January 28^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 - Update from ONC’s Annual Meeting / Enhancing Laboratory Interoperability: Insights and a Path Forward Panel

• February 11^th

Steering Committee:

• TBD

Adjourned

 12: PM ET