Item | Notes |
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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 18 named members, so 2/3 = 12 (excluding chair and government members). |
Open Meeting | 1:05 PM ET - no quorum |
Steering Committee Membership and Officer Roles | These slots are potentially open: 1 Vendor (Labgnostic has not been participating) 2 Healthcare Provider (Nirmala resigned, Craig has not been participating on calls - got new contact at Quest) 1 Patient Advocate (Stacy hasn’t been able to participate) Prefer we ask for interest in the positions, so that we keep the folks on the “list” and get their input directly
Chair and Vice Chair terms expire 3/14/2025, so need to hold elections Reach out to new ASTP/ONC Chief Data Officer if they are interested
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Conferences | ASCLS got accepted - waiting for exact date/time  ADLM got submitted - waiting for response Notes from the FDA Collaborative Community Panel are here: FDA CDRH Collaborative Community Panel |
ISA 2025 reference edition has been published | https://www.healthit.gov/isp/sites/isp/files/2025-01/ISA-Reference-Jan-2025.html |
Other presentations to folks at FDA? | |
Report of SHIELD achievements for 2024 | 4 active SHIELD Working Groups plus the Steering Committee Total of 104 calls held in 2024 which include: 14 ALL SHIELD Community calls 9 Special Topic calls 62 Working group calls (32 LIDR+7 standards+17 comms+6 IVD) 19 Steering Committee calls
Presentations SHIELD members at LOINC 2023 and API 2024; FDA sponsored presentations at LOINC 2024, SNOMED CT 2024 and ASTP 2024 2 presentation proposals submitted for 2025
Provided feedback on 2 federal regulation/initiatives in 2024: USCDI V5 and Proposed HTI-2 Rule List of the speakers on the Special Topics calls in 2024: Synensys and MIT - Report on Systems-theoretic Process Analysis of data Qulaity in the Lab Data Exchange space Pam Banning (Solventum)- Naming Options for Lab Tests within the LOINC terminology Karim Nashar (NHS)- State of Interoperability in the UK Judith Gillis (Amsterdam University Medical Center) - Comparability of lab results - Experiences in the Netherlands Nancy Cornish (CDC) - Specimen Cross-Mapping-Table Dr. James Crawford (Northwell) - Real World Data on COVID-19 Scott Campbell (University of Nebraska) - SNOMED CT Encoded Cancer Synoptic Reports Giorgio Cangioli - FHIR Lab Report Impelementaiton Guide from HL7 Europe Charlie Harpe (Clinical Architecture) - LOINC Mapping Experiences
Several members of SHIELD are supporting HITECH and Sequoia Laboratory Data Interoperability Implementation Guide 5 articles referencing SHIELD work, which are linked to from our website SHIELD Coordination |
Review Working Groups progress | THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!! Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid |
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.
Updated language draft:Roadmap update: ONC Feedback maybe add one more sentence or add a reference to the key consideration number for the IVD Datahub (Consideration 4) into these sentences. (change approved in principle.) Discussion: 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 - from their March 18th call (notes here, recording here) Concepts around Healthcare IT (HIT) standards needs to be conveyed earlier in training for healthcare providers as use and application of standards in vended applications is the major gap. Decision making to use Health IT standards are less likely left up to IT analysts as they mainly follow the requirements and then they generally use vendor supplied implementation guidance. However, a vendor may not support functionality for standards or only partially support. Regulatory requirements (such as CLIA) may pose a hurdle to implementation of data standards. Implementation guidance is often not well read. Training resources may not be well publicized or readily available. Perhaps conformance testing tools need to be made more widely available? What might be helpful is to look at standards implementation from a data lifecycle standpoint across all users (end to end across ecosystem), rather than just training on a single standard for a single use case. Last paragraph on page 4 of the road map final version could be augmented with these points.
Discussion: 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. 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 later Related work at HL7 Europe: | View file |
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| name | EU coded value sets.xlsx |
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Next calls | All SHIELD Calls General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to) Special Topic: Steering Committee: |
Adjourned | 1:34 PM ET |