Strategy for how stakeholders and end-users engage with the SHIELD tooling and available knowledge.
Tools to support clinical interoperability must remove the burden of complexity from local laboratories and implementers. For knowledge artifacts that require unified definitions or mappings, repositories should:
Act as a single source of truth
Easily import knowledge (new IVDs, versions, or mappings)
Easily export knowledge (to local users)
Contain all data elements necessary for the defined use cases
Allow distributed content development
Allow version control
Display knowledge provenance and dependency
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 (e.g. semantic) without the necessary information from another (e.g. traceability) will result in failure.
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
Tactic | Impact |
|---|---|
Laboratory Interoperability Data Resources (LIDR) | Contains necessary class definitions for IVDs and assigned codes |
Controlled Terminology and Semantic Resource | Controlled terminology identifying 1:1 mappings for IVDs and semantic codes |
UDI Repository | Contains necessary device and IVD information |
Reference Standard/Harmonization Hub | Contains information on what analytes have a traceable standard or harmonization procedure. |
Grouping determination re: standardization/harmonization | Primarily a governance problem: will there be a central location telling people if tests from two different IVDs can be trended together, or will this be left to local judgment? |
Use Case |
|---|
A laboratory is adding a new test to its menu. By querying the LIDR, the laboratory is able to define appropriate terminology code mappings for its test, and they are also able to determine that the test is traceable to an international reference standard. |
A health information exchange (HIE) receives information from an EHR about laboratory tests. They receive information about the test, its code, and the device that performed it, but not the traceability information. They are able to query the central repository to access the missing traceability information. |
A laboratory wants to know if it can safely treat tests from two different IVDs as comparable enough for its clinicians to treat them as interchangeable. The laboratory queries the traceability repository and determines that one of the tests is not standardized or harmonized; it decides not to treat the tests as equivalent. |
An IVD vendor creates a new IVD. Using intuitive authoring tools, The vendor publishes the new IVD to the LIDR and includes necessary information regarding recommended terminology codes, the device in use, and information about the traceability of the analyte measurement process. |
Define semantic resource solution
Define necessary identifiers and data elements re: LIDR, UDI, standardization/harmonization
Engage health IT vendors on new functionality required to support transfer of necessary data elements
Engage pre-existing traceability community and its efforts
Develop LIDR Implementation Help Portal
Flat file and web access to necessary static data sources
Laboratory Interoperability Data Resources (LIDR)
Controlled Terminology and Semantic Resource
UDI Repository
Reference Standard/Harmonization Hub
Grouping determination re: standardization/harmonization