Notes from email thread/SC call:
Tailor this to the AMIA audience, which is mainly physician informaticists
May wish to highlight it will help providers and facilities understand where test differences impact values, decisions, algorithms, research and interoperability
Focusing on pain points for data exchange and how SHIELD can help
meaning of tests be distinct, method type is important, impact on incorrect codification of lab tests results in EHR-s
Clinicians care about finding the right test to order, where to find the result and what the next step is for patient care
Focusing on how SHIELD helps improve usability of lab results for providers - example Impact of Chlamydia testing if incorrect LOINC is used
ELR
eCR
HEDIS measures
Insurance reimbursements
data quality inititatives
We could have one panelist bring up the challenges and others could bring the solutions, or we could divide the breadths of issues and address both – the problem and how SHIELD is helping to fix it – on the technical as well as on the policy level.
Word document sections:
Title:
Automating sharing of high quality lab data and how SHIELD can support the Adoption of Standards for Laboratory Data Interoperability and Usability
Abstract:
Learn the latest about the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) stakeholder initiative focused on US national laboratory interoperability needs. SHIELD’s work is to achieve semantic and clinical interoperability from laboratory ordering to performance of laboratory testing on in vitro diagnostics devices, to laboratory resulting to public health and the EHR, to usage of real-world laboratory data for research, surveillance, clinical trials and post market needs. An aim is to help maintain the integrity and complete meaning of a laboratory test to reduce negative decision-making impacts for optimizing patient care and outcomes and improving the quality and availability of data for research, surveillance and public health needs. Use of standards such as LOINC and SNOMED CT in SHIELD initiatives will be discussed.
Introduction:
Laboratory data in the United States is complex, starting with tagging structured data from the in vitro diagnostics (IVD) device through moving specified data to laboratory information systems (LIS), healthcare organizations and patients. In this presentation, we describe challenges across the lab information ecosystem and proposed solutions to harmonize the process of lab information exchange. Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) is a public-private partnership of over 70 organizations representing federal agencies, in vitro diagnostics (IVD) organizations, standards development organizations, medical associations, and other professional laboratory organizations established to build, implement, and support a comprehensive solution that addresses clinical and semantic device interoperability of in vitro diagnostics (IVD) across the nation.
SHIELD strives to create laboratory data interoperability because it will enable accurate public health surveillance, provide confidence to patients and providers in laboratory results and ensure medical researchers that their studies can be reproduced. Attendees will learn more about current challenges with sharing meaningful, consistent laboratory result information between systems, areas where stakeholders need to collaborate to achieve this level of interoperability and harmonization and how they can contribute. SHIELD’s mission is to “Describe the SAME test the SAME way ANYWHERE in the Healthcare ecosystem”
Panel Members:
Jenna Rychert, PhD, ABMM - Medical Director: Operational Informatics, Microbial Immunology, and Customer Support; Director, Laboratory and Clinical IT, ARUP Laboratories
Adjunct Associate Professor, University of Utah School of Medicine
Relevant References:
· Rychert J. In support of interoperability: A laboratory perspective. Int J Lab Hematol. 2023 Aug;45(4):436-441. doi: 10.1111/ijlh.14113. Epub 2023 Jun 20. PMID: 37337695.
· Rychert, J. LOINC Management in Reference Labs. 2023 LOINC Conference.
Pamela Banning, MLS(ASCP)cm, PMP – Senior Healthcare Content Developer, Solventum Health Information Systems; Laboratory LOINC Committee Chair
Relevant References:
· Banning, P. Mapping in Action: Mapping Local Test Codes to LOINC. 2024 LOINC Conference
· Banning, P. In-roads: Advancing LOINC Adoption in Clinical Trials. 2023 LOINC Conference
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Relevant References:
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Discussion and Conclusion:
Discussion Topics – Jenna Rychert:
Keeping LOINC up to date - ensuring the lab has processes in place to get the best LOINC assigned as the test evolves over time and as LOINC evolves over time
LIS limitations - often the assumption is that there is no need for the LIS to communicate outside of the EHR it is built into
HL7 2.5.1 inbound is not possible
Assigning SNOMED to qualifiers (Negative, Positive, etc) is not available
Mechanisms for assigning LOINC for Microbiology are clunky and don't exist for AP
No mechanism to assign LOINC at the order level, only the result level
No reflex mechanism outside of the micro module
No support for more than one standard code system (standard code system is hardcoded)
No standard support for specimen attributes (most have a single bucket they call specimen source, some have type and source site) making it hard to properly describe specimen, particularly for AP and micro (infection control follow up)
Requirement to have a result in order to produce a report (for example when a specimen is rejected – that should really not be reported as a result)
Order level LOINC is often requested by clients, especially for public health reporting but it isn't always practical to attempt to assign a LOINC
HEDIS measures - we are finding that our clients are trying to provide lab data that that is needed for HEDIS but the LOINC ARUP provides is not on the list of acceptable lab tests (maybe the new LOINC ontology will help address that and the HEDIS panels could define mostly the analytes that should be included rather than kuisting explicit LOINCS as part of the panel (think of it as a valueset definition that gets expanded every time it is called, so that new additions can be considered?))
Discussion Topics (tailor as needed) – Pam Banning
· Examples of why LOINC is not a total solution for systemic interoperability
· Keeping LOINC up to date from an IVD manufacturer perspective. SHIELD encourages use of IICC’s LIVD format for communication of approved LOINC terms. Examples of resources needed
· Types of missing information from LIVD files (Supporting information)
· Lab LOINC activities in improving LOINC for clinical laboratories; basic interoperability of systems
· Known content gaps in LOINC
o Flow Cytometry / Special Cell Immunology
o Patient Generated Health Data
Discussion Topics - Julia Skapik
Integrating laboratory data across the lifecycle of healthcare: The role of UDI in ensuring valid laboratory data flow
The proposal would then describe multiple views in succession from upstream to downstream:
IVD vendor process
Lab ordering and testing
Transmission of lab results to healthcare entities and patients
Validation and reuse of lab data across downstream use cases (not patient care but things like billing, public health, etc)
Ideally we would at each transition point describe the existing challenges to seamless data transmission and then suggest approaches that would facilitate closing these gaps.
Discussion Topics - Marjorie Rallins
Discussion Topics Steven Emrick
Overall References??:
Luu, Laboratory Data as a Potential Source of Bias in Healthcare Artificial Intellgence and Machine Learning Models, Annals of Laboratory Medicine, 2024, October 24, PMID: 39444135
Semantic Interoperability for In Vitro Diagnostic Systems. 1st ed. CLSI report AUTO17. Clinical and Laboratory Standards Institute; 2023.
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