2024-01-16 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

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

Follow up Items

• Special Topic calls:

  • Confirmed:

    • LOINC Naming Call (Pam): Feb 13th

  • Proposed:

    • State of Interoperability in the UK - March 12th

    • Netherlands perspective (Andrea reached out to Feika and Dirk, no response - Eza might be able to help)

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

Presentations etc

• Children’s Health Laboratory Medicine Conference Feb 16 - Andrea and Riki will present SHIELD overview with the specific viewpoint around impact of SHIELD work on laboratorians - bring slides for review on SC call Feb 6th

• API submitted SHIELD abstract for Hung Luu to present, if accepted

CAP Today Article Update

Next steps:

• draft the description of the story we want the article to tell

• solicit participation from the stakeholder groups once we have the

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

• IVD Data Hub

• Standards Updates and Vocabulary Working Group

• Communications and Branding Working Group

2024/25 Conferences we might want to submit abstracts to

• Executive War College Apr 30 – May 1, 2024 in New Orleans, LO Steve will be attending - need any help?

• ADLM (submission deadlines for 2024 presentations passed, but consider 2025)

Patient Generated Health Data & LOINC Chairs

Discussed as cross-cutting topic during LOINC Committee Chairs Meeting 1/11/2024

1. This followed a Pre/Post coordination discussion across all committees on the agenda; nursing and radiology have much different needs than lab when it comes to pre/post coordination BUT a solution needs to be applicable for all areas of LOINC

2. Friends Personal Encounter for unsolicited PGHD  – a personal friend is on Medicare AND has had kidney function monitored for decades. The insurer sent an http://Healthy.IO kit to them and did several follow up calls when they hadn’t complied.

3. Different Information Flow is observed

   1. Seems to be recorded through Insurer database for patient; not necessarily including the medical record from dr office notes or from laboratory reporting to inpatient/outpatient records

   2. LOINC used in HEDIS ; more of an administrative use case for physician care over their patient populations.

   3. Lab LOINC’s first introduction of the microalbumin/creatinine home kit (http://Healthy.IO ) was from National Kidney Foundation, which claimed someone at some level was trying to satisfy a HEDIS measure and needed a LOINC.

   4. We didn’t get http://Healthy.IO to answer emails or inquiries thus no LOINC submission is currently in place. Awaiting 2024 task force discoveries cross-cutting within LOINC committees (NEXT STEPS below).

4. FDA is approving these devices, but has not conveyed to SHIELD or LOINC that codes need to be created, nor devices included in LIVD. NKF asked for a LOINC to keep the HEDIS measure pure for CLIA approved laboratory values and distinct from patient/home collected measurements.

5. It is unknown what FDA or ONC / USCDI have in plans for future, if anything. [SHIELD members, please keep eyes open]

   1. HL7 FHIR PGHD Implementation Guide is geared for pandemic reporting to public health  https://projectlifedashboard.hl7.org/specifications/hl7-fhir-us-home-lab-report-v0-1-0/

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.

Looking for volunteer to tackle this re-write: Reordering the Considerations and moving the IVD Data hub last and renaming the section to “Making Well Standardized Data Available for Secondary Use” - we could then list as a first use case the IVD data hub, but we could expand this section with other uses we described under the business drivers and expand more on what each individual stakeholder can do to improve interoperability in the section on moving data through the systems

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).

Renaming of LIDR update from LIDR WG:

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: January 23, 2024

Special Topic: February 13, 2024 - LOINC Naming Conventions

SC: February 6, 2024

Adjourned