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There are four significant areas of medical knowledge that need to be represented in systems for clinical interoperability to be successful. Attempting to rely on one area Attempts at clinical interoperability using only one level of mapping (e.g. semantic) without the necessary information from another (e.g. traceability) will result in failurejeopardize patient safety.
Semantic/ontological relationships
Defined terminology mappings assigned to IVDs
Clinical reference standard traceability/harmonization status
Direct comparability of laboratory results requires the knowledge of whether those results are both traceable to a reference standard material or harmonization procedure.
Clinical interpretation data elements
E.g. result value, units, reference range, specimen type
Device/manufacturer data elements
E.g. UDI for device, kit
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