2024-04-16 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 - 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 - regrets

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 - regrets

primary

Dari Shirazi

alternate

Graphite Health

Stan Huff - regrets

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

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 12:07 PM, 6 attendees. quorum not reached

Follow up Items

• 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)

    • Other topics?

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

  • Continued work on white paper

• IVD Data Hub

  • ALL SHIELD call update next week, slides. Are other WGs having attendance challenges? IVD vendor interest and participation.

• Standards Updates and Vocabulary Working Group

  • Next meeting May 6th

• Communications and Branding Working Group

  • Discussed CAP Today article and moving forward. Brainstorming on stakeholders within SHIELD have a forum to express different perspectives, interests, internal communication, etc.

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.

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

Proposal from IVD Data Hub team. Will send to SC when ready.

Updates:

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 example 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

Placeholder to get back to

Related work at HL7 Europe:

CLIAC Update: Recognition that standard work is needed. Nothing specific to SHIELD. Dr. Vesper’s presentation on harmonization of testing, chronic diseases. Limited time with all the topics. A number of members were not aware of harmonization.net. Plans to expand harmonized tests?

Limitations on availability of resources (time, $, resources, equipment).

Strategy to engage laboratories. Albumin. Most platforms have both methods available. Move to a preferred method? Robyn/AMP. Professional organizations cannot support a particular product or service as it opens up to liability. Need to preserve laboratory directors ability to decide under their professional practice as to right test for their environment. Bring forward data as to best practices. Dr. Vesper has a similar take. They work on data on the analytical performance of assays and let folks decide if performance meets their need, so physicians can make right decisions. Sometimes others make funding decisions and the laboratory has to work with those constraints. Once an assay is approved within CLIA certified laboratory, they may continue with it, instead of switching to something more comparable to a data hub system. Dr. Luu, indicates more is needed from differ assays. 0.4 assay difference when switching IVD vendors. Dr. Skapik, fantastic example of how complex this can get and may not have clinical background. Organizations may not trend different lab results/methods differently. Lack of specificity in small places can have systemic effects. If we raise this, we’ll stop integrating albumin. Robyn, point is well taken, would love to have standardized reference materials to have baselines up front to have cleaner data. Been discussing since 1996. Andrea asks would EHRs/practices be willing to build method specific tests, additional items. Dr. Luu thinks its good practice to build separate lab results and not comingle different results. Dr. Skapik, this is not an EHR thing, but point of care mapping. Many do not know what they are doing from a clinical or terminology perspective or both. That said, anything that is difficult for users. Opportunity to display information better. Not what folks are doing with AI. Without clear guidance from vendors that understand nuances, researchers that understand nuances, don’t see it implemented differently. Can we display information in different colors, and then understand why different. Lot of usability aspects here. Without variation being meaningful for users. Eric, says does the EHR need a separate bucket for variations. Is where we are headed with UDIs with other attributes, it goes into the same bucket, but we have other details that can be leveraged to analyze what we are looking at here. Perhaps the bucket has other attributes. Dr. Luu, they were early adopter of Happy Together. There are 2 options. Can map external lab to internal test name so transforms to local name. Appears like native internal lab result. 2. Alternatively, can produce copy of separate result, but not many are taking this path. HIT vendor documentation presents both, but no guidance on which to choose. Dr. Vesper, IVD data hub data that is interchangeable to add to their database so they can feed into IVD data hub. Incentives. People measure time from phlebotomist to reach the laboratory, as an indicator of quality. Questions if the data from a laboratory are of quality. For those developing quality parameters, want quality indicators for interoperability. Dr. Skapik, provenance use case. Would be interesting to work on a team for provenance. Would be nice to automatically generate rules from place to place and keep metadata in translation and guidance on point of care. Dr, Skapik sees codes, descriptions about source data, use resources to look up proprietary codes. When talking about provencance, can’t modify code and description. Some is messiness of manual builds and not understanding best practices. Robyn, also true from her experience. Based on provider preference, an oncologist may want lung biomarkers panel and may not care about reference laboratory. It may not matter to ordering provider. EHR vendors need to adjust. Dr. Skapik, create a display name. Robyn, often people who don’t have training or skill. Some are being pulled from lab bench, need marriage of both worlds, lab and EHR to have usable data.

Next calls

All SHIELD:

General Updates: April 23, 2024

Special Topic May 14, 2024: Netherlands Experience:

SC: TBD

Adjourned

12:?? PM ET