2024-02-20 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

Started 12:09 PM, quorum reached at: 12:42 PM

Follow up Items

• Special Topic calls:

  • Next dates:

    • April 9th

    • May 14th - Netherlands

    • June 11th

  • Proposed:

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

Presentations etc

• Children’s Health Laboratory Medicine Conference Feb 16 went well, slides were shared

• API SHIELD abstract was accepted, so Dr. Hung Luu will present on behalf of SHIELD (May 20-23, 2024)

• CAP article outreach has started

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

  • did not meet this week

  • last week discussed Unique device identification and UDI

• IVD Data Hub

  • still need more participation - moved the call to Thursdays 11:00 AM

  • need to figure out how to expand the use of the data hub - right now looks too limited to only IVD post-market - working on the update to the roadmap section around the description of the datahub

• Standards Updates and Vocabulary Working Group

  • Still looking for another Co-Chair!

  • Reviewed the LRI specification: came up with 14 data element to identify all available standards - gap analysis on these:

    • Administrative Sex

    • Race

    • Interpretation Codes

    • Observation Result Status Codes

    • InterpretationResult StatusValue TypeSpecimen TypeSpecimen Reject ReasonSpecimen ConditionRelevant Clinical InformationDevice TypeLOINCSNOMED CT

    • UCUM

• Communications and Branding Working Group

  • moved to Thusdays 4 PM, every other week to be confirmed

Feedback on ONC published artifact - do we want to compile as SHIELD, or just as members?

• USCDI+ - USCDI+ Service Portal due to ONC by March 4, 2024

• United States Core Data for Interoperability (USCDI)(including USCDI v5) due to ONC by April 15, 2024

• 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

• Decided last SC call to focus on Unique Testkit Device Identifier

Discussion:

There is quite a bit of push back on this data element

Should support testkit and instrument device identifiers, in order to accommodate different patterns

provide a way to be able to use data generated as part of regular care for FDA regulatory AND OTHER secondary uses

mitigate infrastructure gaps - certification for LIS does not exist at the moment, so missing central player in the ecosystem

also see updates on Unique Testkit Device Identifier

DI part of the UDI is a synomym of manufacturer and model - GUUID

Manufacturers have a lot of work to maintain the UDI for FDA - was a 3 year project to get this organized - don't really want to do something else / in addition

Proposed comment: Drop “unique” from the name

Could we make a LOINC for things that would not have unique identifiers - like LDTs?

• maybe use SCT to represent this as procedures? or brands/products?

• This needs to be computable - maybe use the CLIA number of the lab and a procedure code for the method? - this would keep this within the CLIA test system

  • does this scale internationally?

• issue with text for manufacturer and model is not computable and there are changes over time in name of manufacturers and the kits, too (rebranding)

Should support implementation of IHE LAW = CLSI-AUTO-16, which includes transmission of device ID form the instrument to LIS - LIS needs to be able to retian and share those!

What would need to happen to include LIS under ONC certification to over gaps?

• There would need to be incentives for LIS vendors to create and the labs to adopt this certified technology

• We think there might have been regulation that FDA could not require LIS certification

• Primary barrier would be setting up the workflow for LIS certification testing

SInce we are dealing with different perspectives in the industry in this group providing feedback on this tight a timeline might not be the best approach

Riki will email a proposed statement to the Steering COmmittee and ask, if we should bring this up on the ALL SHIELD call next week or vote via email, since comments are due March 4.

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.

Next calls

All SHIELD:

General Updates: February 27, 2024

Special Topic: March 12, 2024 - State of Interoperability in the UK

SC: March 5, 2024

Adjourned