2024-01-02 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

Andy Harris

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

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

James T. 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

Dari Shirazi

alternate

Graphite Health

Stan Huff

primary

alternate

CAP

Raj Dash

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

OPEN

primary

alternate

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

Open Meeting

 12:06 - no quorum though

Follow up Items

• Special Topic calls:

  • Confirmed:

    • Synensys Update - Jan 9th

    • LOINC Naming Call (Pam): Feb 13th

  • Proposed:

    • State of Interoperability in the UK - March 12th

    • Netherlands perspective (Andrea reached out to Feika and Dirk, no response - Eza might be able to help)

    • Use of standards and reporting across the different systems used in Cancer and Pathology

Presentations etc

• Children’s Health Laboratory Medicine Conference Feb 16 - Andrea and Riki will present SHIELD overview with the specific viewpoint around impact of SHIELD work on laboratorians - bring slides for review on SC call Feb 6th

CAP Today Article

Have offer to have several folks of the SHIELD community be interviewed for a CAP Today article about SHIELD

Email to get approval for this article - define the message to get across, if that is possible; by providing them with SHIELD overview

need to get an idea of how many folks they want to talk to

Consider including list of options for interoperability improvement - for each stakeholder group - what can I do?

Suggestions for names = representatives from different stakeholder groups - IVD vendors, SDO, Lab, Government agency?

SC members or others could volunteer and review that list in the SC

ACTION: Send email for general approval of article and solicit participation from the stakeholder groups once we have the story we aim for

Review Working Groups progress

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 update

• IVD Data Hub

  • no update

• Standards Updates and Vocabulary Working Group

  • no update

• Communications and Branding Working Group

  • CAP article thoughts - see above

  • Come up with a “How can I improve data interoperability”

    • CAP Today survey of support for interoperability (maybe as part of their LIS survey and other vendor types)

2024/25 Conferences we might want to submit abstracts to

• Executive War College Apr 30 – May 1, 2024 in New Orleans, LO Steve will be attending - need any help?

• ADLM (submission deadlines for 2024 presentations passed, but consider 2025)

• API (submission deadlines for 2024 presentations passed, but consider 2025) - due Jan 7th

  • Andrea and Riki working on SHIELD abstract - would Hung be able to present that, if accepted - will do email vote

• APHL - did not get accepted as presentation - should we submit for a poster? - due Jan 26th

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.

Riki suggestion: I suggest reordering the Considerations and moving the IVD Data hub last and renaming the section to “Making Well Standardized Data Available for Secondary Use” - we could then list as an example the IVD data hub, but we could expand this section with other uses we described under the business drivers

Discussion:

Expand more on what each individual stakeholder can do to improve interoperability in the section on moving data through the systems

Don’t adjust the mission - would also need to redo the charter, if we did that

Looking for volunteer to tackle this re-write

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.

Riki suggestion: Under the Data Semantics Section suggest we expand on the need for training for any of the standards - we should also adjust the language somewhat to highlight that we focus on LOINC here, because it had been suggested as a single solution to the problem for a while - we can re-focus this paragraph a little more on the need to use multiple semantic standards and to create an ontology covering the clinical context of laboratory data (i.e. the need for knowledge representation)

Discussion:

Similar challenges exist with other standards - address with eye towards more education and consistent implementation of ANY standard

Ask the Standards and Vocab WG to re-write this section

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).

Riki suggestion: Some of this content was originally in the document, when it was still called “Strategic Plan”, but was felt was overstepping boundaries, so was removed - we would have to carefully decide, if this should be added here, or if this is better addressed in a stand-alone document perhaps.

For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR (and update its fully spelled out name from “Repository” to “Registry” to create more of a distinction between library function vs patient level data)

Discussion:

Need to discuss the renaming of LIDR - this came from FDA - Registry (SCT uses this for namespace) vs Repository (NIH uses this for their data element repository) or other name - put on agenda for LIDR WG and bring back to SC for consideration

• For Sonic:

  • Registry contains patients in a group

  • clincial data is in repository

Make sure we add these to glossary

Being more clear around what data elements will be added and how this will be used - example UDI - looking at patterns in lab data / how will this be used in implementations?

Repository provides the easy access to standardization - use for implementation of the required standard - regulation can call out what MUST be used - repository provides the how to represent each data element and hopefully makes it easier to implement

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

Next calls

All SHIELD:

Special Topic: January 9, 2024 - Synensys Final Report

General Updates: January 23, 2024

SC: January 16, 2024

Adjourned

12:59 PM ET