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
Agenda and Notes
em
Notes
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
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
Collaterol: 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:
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
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.
Different Information Flow is observed
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
LOINC used in HEDIS ; more of an administrative use case for physician care over their patient populations.
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.)
Awaiting 2024 task force discoveries cross-cutting within LOINC committees (NEXT STEPS below).
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.
FDA, ONC / USCDI, standards development future impacts?
HL7 FHIR PGHD Implementation Guide is for consumer performed testing reported to public health
Need more than just the LOINC code, need UDI and additional information. USCDI, UDI, and LIDR needed.
How to convey UDI in Auto 16 and communicating that information flow to LIS. UDI from manufacturer. IVD device and LIS
Discussion on requiring a UDI in USCDI and implementation aspects
industry not able to capture currently, transmit, etc.
process for operational/implementation
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.
Intent/where are we going? simple vs complex results
some folks not familiar with UDIs
USCDI aspects. Encourage folks to add comments on USCDI so captured/visible on healtit.gov website. Share any documentation/evidence with Sara/website.
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
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
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
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
Recording:
From Chat:
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