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Date

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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  Victoria Derbyshire - regrets

alternate

Agenda and Notes

Item

Notes

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

 12:0? 10 PM ET, no quorum reached

Reminder of open action items / outcome of action items

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:

  • # of proposals submitted

  • # of times feedback on federal regulation/initiatives provided

    • 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 sepakers speakers on the Special Topics calls in 2024:Active WGs and total number of calls held

      • 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 https://aphlinformatics.atlassian.net/wiki/spaces/SC

    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

    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 (smile)

      • 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:

      View file
      nameDRAFT_SHIELD_Community Roadmap_11_4_2024_Latest_Version.docx

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

    • Anything else needed on this one?

    1. 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 18th 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

    1. 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:

    View file
    nameEU coded value sets.xlsx

    Next calls

    All SHIELD Calls

    • December 17th

    • January 28th

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

    Special Topic:

    • January 14th - Update from ONC’s Annual Meeting / Enhancing Laboratory Interoperability: Insights and a Path Forward Panel

    • February 11th

    Steering Committee:

    • TBD

    Adjourned

     12: PM ET

    ...