2024-10-15 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 - 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

alternate

Regenstrief Institute

Marjorie Rallins

primary

Eza Hafeza - regrets

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

Michael Smalara

primary

Open

alternate

ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

alternate

NLM

 John Snyder

primary

alternate

FDA

 Keith Campbell

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

 12:09 PM ET, but no quorum

SHIELD Presentation at ASCLS June 8-12 in Sacramento, California

Considering submission of abstract, but looking for speakers - https://www.cvent.com/c/abstracts/a0f08f8a-77b8-488c-8fa9-38672d10b40d

Riki can attend, since she is local - are there others who know they will be attending and want to present?

will be email request

Nirmala had attended a webinar for proposals, can repurpose HIMSS proposal, add Riki as presenter and add on anyone else who wants to present - request bios for each of the presenter

30 min 1 presenter, 60 min up to 4 presenters

Use the LOINC proposal - Andrea will share with Eric, as that is closer to the ASCLS audience

Riki will send email requesting vote on the principal of doing a presentaiton at ASCLS / submitting a proposal

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

Discussion:

• need to locate where exactly in the roadmap the new text lands - Hung will take a stab at that - thank you!

• Discussed meaning of updating instruments

  • harmonization here is not at the method level - though ultimately if we have that, then we’d be much better off, harmonization here is about the data produced by the insturments and the meta data about the reagent / protocol and instrument used, so comparability of results can be assessed

  • changing an instrument now is very invasive, requires a lot of work and differs between instruments

  • decided to change sentence to reflect that these are changes to the testing done by the lab.

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:

• What does IT folks are less suceptible mean?

  • IT folks usually have requirements documents and then step by step vendor instructions, when they implement (if vendor does not support, that would be a different issue)

  • it is actually good, when there is only 1 field for a given data element - example LOINC, everyone knows where that is, so you can figure out if code is correct for example

  • There are other elements that are sent in multiple places, depending on the implementation:

    • reference range:

      • in the proper field

      • in a comment, since proper field does not suport a table, when not all attributes that can affect the reference range are known to the lab

    • units of measure

      • in the proper field (either coded, or just as text

      • as part of the value (and if the value gets truncated, then this will be lost)

  • Above list can grow - Standards group needs to review these and others that fall into this category

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.

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

• Steering Committee attendance review

• consider changing timeslot

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

  • Work continues on white paper - review final draft before sending to SC

• IVD Data Hub

  •  no update

• Standards Updates and Vocabulary Working Group

  • No new updates

• Communications and Branding Working Group

  •  working on a survey to SHIELD members to better understand what makes folks participate / not attend calls / better understand each stakeholders' perspective - for next SC call

Antimicrobial result reporting

Placeholder to get back to later

Related work at HL7 Europe:

Next calls

All SHIELD Calls

• October 22^nd

• November 26^th (week of Thanksgiving – or meet November 12^th?)

• December would be 24 or 31 – do we want to meet 17^th?

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

Special Topic:

• December 10^th - Clinical Architecture LOINC survey

Steering Committee:

• November 5^th

Adjourned

 12:53 PM ET