2024-04-09 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 - regrets

primary

Roche

Yue Jin - regrets

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 - regrets

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 - regrets

alternate

Graphite Health

Stan Huff

primary

alternate

CAP

Raj Dash - regrets

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 - regrets

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 12:08 PM, no quorum reached

Report on progress to FDA Collaborative Community - NOT DISCUSSED

Review report for 2023 and goals for 2024

will include in email for approval to send back to FDA by 4/12

Follow up Items - NOT DISCUSSED

• Special Topic calls:

  • Next dates:

    • May 14th - Netherlands

    • June 11th - 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)

Review Working Groups progress - NOT DISCUSSED

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

• IVD Data Hub

• Standards Updates and Vocabulary Working Group

• Communications and Branding Working Group

Feedback on ONC USCDI V5

• 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

Collating comments here: SHIELD Feedback on USCDI V5 Draft

Capturing some discussion here:

Test Kit Identifier - since we are requesting UDI, should work on IHE LAW = CLSI AUTO-16 udates to support that

Instrument Identifier - should be added also, since go hand in hand with Testkit Identifier

What about the class agnostic medical device data elements USCDI level 2: https://www.healthit.gov/isa/uscdi-data-class/medical-devices#level-2

• Issue with these generic data elements is that you still need to define for each use case (data class) how they need to be used

  • if we want to be able to say for lab must have test kit DI and instrument DI, for blood pressure must have instrument DI, for implantable device must record full UDI (or DI + PI or whatever the rules are) would need to add some attributes to the current USCDI data element to accomplish that

  • another example would be the Lab related date/timestamp element - without efining at what triggers these need to be captured it is not very useful

  • ideally this should be set up so that additional constraints can be added to the generic data elements for each use of the element in its clinical context, as long as the element is still the same - if we go that route MANY current elements in USCDI would need revisions

HAVE TO VOTE TODAY - OR VIA EMAIL - didn’t reach quorim, so will send email

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: April 23, 2024

SC: April 16, 2024

Also May 7th neither Chair nor Vicehair is available - should we just cancel or move to April 30th?

Adjourned

1:01 PM ET