2024-06-04 Meeting Steering Committee 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 - regrets

alternate

HL7

Julia Skapik

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick - regrets

primary

Dari Shirazi

alternate

Graphite Health

Stan Huff

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

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).

12:08EST

Welcome to Michael Smalara as CMS representative

Open Meeting

HIMSS Proposal

• Eric Crugnale and Julia Skapik

• Discussion

• Vote to approve submission

• Submissions Due June 10th

Discussion on who will be attending and who to pull into a panel about SHIELD. Government agencies also have clearance. ONC will have multiple folks and will need clearance to participate.

2 or 3 people presentators. Julia Skapik, Eric Crugnale, ONC person. 1 hour. Eric and Julia to connect and have a draft proposal. Aim by end of day Wed.

Andrea will share slides from LOINC with Eric, Julia, Sara?

Title/Focus: End to End lab interoperability. educational and future. public private partnership. applied focus.

data Warehouse examples Julia. ONC USCDI data items.

IMO/Clinical Architecture, who act as surrogate.

Plan to send by Fri for E-Vote due by Monday for submission by June 10th deadline.

Follow up Items -

• Special Topic calls:

  • Next dates:

    • June 11th - CWRDi Dr. James Crawford

    • July 9th - Open, Specimen CrossMapping Table?

    • August 12- Open, Specimen CrossMapping Table?

  • Proposed:

    • Use of standards and reporting across the different systems used in Cancer and Pathology - ask CAP folks if interested / someone available (Scott offered)

• Follow up from Collaborative Community Report to FDA - Keith / Vickie. Keith gave a presentation. Love the information. Short presentation of High Points. Presentation later this week to leadership

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

  • White paper. Discussion on Specimen Information. Plan to include Scott to a future call.

• IVD Data Hub

  • No substantial updates Will meet next week.

  • Good conversations about data hub and ongoing initiatives with the landscape assessment.

• Standards Updates and Vocabulary Working Group

  • No updates

• Communications and Branding Working Group

  • Deloitte team has a lot of materials. Eric

  • Elevator pitches and CAP article

  • Deloitte has a quite a bit of information. What is most of interest?

  • Strengths and Challenges in SHIELD. Help prepare for questions about/gaps in SHIELD.

  • Vicky will share 1 pagers, high level overview documentation.

  • Meeting tomorrow. Feel free to email Vicky with any needs.

ONC Feedback

• ONC January 2024 Health IT Standards Bulletin due to ONC by July 2024

  Information about the SVAP 2024 can be found at: = Standards Version Advancement Process

Roadmap section updates in response to ONC comments on the SHIELD roadmap - NOT DISCUSSED

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.

From last SC call: Nick will connect with Sara to get more context and then bring this to the IVD datahub group - then Nick will bring back here

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?

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 exampel implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

Looking for volunteer to tackle this re-write: 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 - NOT DISCUSSED

Placeholder to get back to later

Related work at HL7 Europe:

Next calls - NOT DISCUSSED

All SHIELD:

General Updates: June 25, 2024

Ask about SC: June 18, 2024

July 4th week call availability.

July 2nd SC: iffy attendance. Hung around. Jim Case out.

Adjourned

12:44: PM ET