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

• Previous call electronic votes passed

• Special Topic calls:

  • Confirmed:

    • LOINC Naming Call (Pam): Feb 13th

  • Proposed:

    • State of Interoperability in the UK - March 12th

    • Netherlands perspective/ interoperability solution(Andrea and Eza reached out to Feikje)

    • 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

• APHL - did not get accepted as presentation - Andrea and Riki decided NOT to do a poster for this year’s APHL Annual Meeting, despite the SC members vote to suport it, as they are not commonly accepting many informatics topics as posters

CAP Today Article Update

Next steps:

• Steering Commitee approved to progress

• Communications workgroup working on

  • Points to highlight

  • People to interview

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

  • Outline of White paper completed in Dec. Working on draft for Q1, Q2 publication

  • WG working on coding in Spreadsheet for Potassium example

• IVD Data Hub

  • Met last week. Continued work on White paper outline. Draft goal end of Q1.

  • Simon Mason NEST meeting/introductions

• Standards Updates and Vocabulary Working Group

  • Met on Jan 8. Working on several tests for use cases for interoperability challenges and identification of standards

    • D-dimer from roadmap

    • Category info needed for interoperability: LOINCs, reference ranges, methods, instrument, LIDR/LIVD items,

    • pull package inserts, have some HL7 messages and sample reports. Looking at different labs to see how they represent data.

  • Next up:

    • AST

    • Urine Culture and Susceptiblity

• Communications and Branding Working Group

  • Met last week.

    • Moving process forward with CAP Today Article. Kevin Schap checking on some things.

    • What questions are for interviewees?

    • Outline

    • SHIELD’s goals/highlights

      • Recruiting other industry stakeholders/participants

      • Overview of SHIELD, how it alligns with other organizations in the interoperability space, key deliverables (e.g. LIDR), clear vision/mission, how can lab professionals help

      • Collateral: flyer, etc.

      • What is SHIELD, What does SHIELD do, What stakeholder group do you represent, How can SHIELD benefit, What can labs do to prepare for inteoperability in future?

    • Recommendations for stakeholders for interview

      • IVD representation: Xavier and/or NIck

      • SHIELD leadership: Riki and/or Andrea

      • Pathologist/Laboratory: Hung

      • Lab Organizations: Raj

      • Standards Organizations: Marjorie and/or Eza

      • Commercial Labs: Eric Crugnale

      • Government: Keith

    • Additional details in minutes

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? SHIELD flyers?

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

LOINC Chairs Meeting (1/11/2024)

Discussed Patient Generated Health Data (PGHD) as cross-cutting topic:

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. PGHD example: Medicare patient who’s kidney function monitored for decadse, sent home urinalysis kit. http://Healthy.IO Insurer followed up several times 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 post around National Kidney Foundation question about microalbumin/creatinine home kit being used to satisfy a quality/ HEDIS measure. (Resolution: qualitative results reported, incorrect LOINCused/didn’t meet quality reporting criteria.)

   4. Awaiting 2024 task force discoveries cross-cutting within LOINC committees (NEXT STEPS below).

4. FDA is approving these devices, but appears IVD vendors are not requesting LOINCs for these new test methods. Many IVD vendors not yet providing LOINC maps in LIVD format.

5. FDA, ONC / USCDI, standards development future impacts?

   1. HL7 FHIR PGHD Implementation Guide is for consumer performed testing reported to public health 

6. Would be helpful for FDA to know more about how many LOINC requests are mahttps://projectlifedashboard.hl7.org/specifications/hl7-fhir-us-home-lab-report-v0-1-0/de from IVD vendors versus not?

7. Need more than just the LOINC code, need UDI and additional information. USCDI, UDI, and LIDR needed.

8. How to convey UDI in Auto 16 and communicating that information flow to LIS. UDI from manufacturer. IVD device and LIS

9. Discussion on requiring a UDI in USCDI and implementation aspects

   1. industry not able to capture currently, transmit, etc.

   2. process for operational/implementation

   3. Although ways to convey UDI in IHE-LAW, not do-able today. EUAs and UDIs. Good Starting discussion for Data Hub Workgroup. More than one UDI, may be complex. Need to roadmap to avoid failure.

10. Intent/where are we going? simple vs complex results

    1. some folks not familiar with UDIs

11. USCDI aspects. Encourage folks to add comments on USCDI so captured/visible on healtit.gov website. Share any documentation/evidence with Sara/website.

Sequoia Lab Tiger Team call 11Jan2024

Data Usability Workgroup

• Synensys Presentation

• Review of Google Sheet listing Priority lab results (Sequoia) and corresponding LOINC/test info. Tool to educate on variety of lab tests and data

  • crawl, walk , run

• Goal to have draft for interoperability by July

  • Use existing standards

• Discussion

  • Need rigor and expertise in lab exchange space.

  • Also if not aligned with direction of SHIELD, may want to pull back/walk away.

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