Ideation
Strategy Alignment Legend | |
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User Experience and Functionality Strategy for how stakeholders and end-users engage with the SHIELD tooling and available knowledge.
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Infrastructure and Integration Strategy for how the tooling and knowledge management environment will operate and integrate with external systems and standards.
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Knowledge Management and Analytics Strategy for how knowledge will be captured, versioned, and curated over time in a highly reliable and patient-safe way.
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Strategy for ensuring the quality, fit-for-purpose, and usefulness of available knowledge.
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Use Cases
At a high level, the SHIELD Initiative’s clinical interoperability effort has three major goals:
Clinical interoperability of laboratory results
Public health surveillance and reporting
Performance monitoring of in vitro diagnostic tests
Necessary Tools and Functionality
Problem: Mapping laboratory tests to terminologies is non-standardized, error-prone, and highly labor-intensive. The end product is ineffective for the above use cases.
Solution:
Develop tools that:
Define a single source of truth for correct mapping of IVDs to codes and make it easily accessible
Assure the quality of the mapping process to guard patient safety
Contain all necessary data elements for downstream use cases
Ease import and maintenance for laboratories, manufacturers, and health IT vendors
Clearly communicate to vendors what they must support in the future
Tool | Tool Type | Strategy | Description |
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Laboratory Interoperability Data Resources (LIDR) | Class Repository | Knowledge Management and Analytics | Contains necessary class definitions for IVDs and assigned codes |
Controlled Terminology and Semantic Resource | Knowledge Architecture | Knowledge Management and Analytics | Controlled terminology identifying 1:1 mappings for IVDs and semantic codes |
Reference Standard/Harmonization Hub | Class Repository | Quality Assurance and IV&V | Contains information on what analytes have a traceable standard or harmonization procedure. |
UDI repository | Class Repository | Knowledge Management and Analytics | Contains necessary device and IVD information |
Application programming interfaces | Vendor Functionality | Infrastructure and Integration | When possible, data sources should offer programmatic interfaces |
Automated lab catalog and data dictionary maintenance tools | Vendor Functionality | User Experience and Functionality | Ideally laboratories/vendors would not need to manually look up necessary LIDR or semantic mappings--searching within the LIS via API calls to necessary repositories would ease burden |
LIDR/UDI IVD Vendor Authoring Tool | Authoring Tool | User Experience and Functionality | Make it easy for vendors to assign codes quickly and well. |
LIDR Implementation Help Portal | Website | User Experience and Functionality | Education resources for labs and hospitals implementing code mappings. Training for harmonization, workflow integration and data exchange. Includes auto-population tools for labs, reference implementation for testing messages and message validators. HL7 v2 and FHIR support. |
Third party search | Vendor Functionality | Infrastructure and Integration | If a third party (i.e. not the laboratory or the original result destination) received a subset of result data, would they be able to quickly obtain missing data elements from LIDR or re: harmonization status? |
LIS/EHRs' ability to store and exchange needed data elements | Vendor Functionality | Infrastructure and Integration | Not all necessary elements (e.g. UDI) are supported in current systems |
Laboratory testing QC data repository | Instance Repository | Quality Assurance and IV&V | By monitoring individual testing data, a QC data hub would potentially 1) identify testing that can safely be treated as similar 2) identify incorrectly mapped tests |
Grouping determination re: standardization/harmonization | Knowledge Architecture | Quality Assurance and IV&V | Primarily a governance problem: will there be a central location telling people if tests from two IVDs can be trended together, or will this be left to local judgment? |
Real World Evidence data hub | Instance Repository | Quality Assurance and IV&V | National database of testing data allowing performance monitoring of IVD and device-related issues. With linkages, could be used in evidence generation. |
Necessary Data Elements (General Classes)
Problem: To support clinical interoperability, we need detailed enough information about tests to:
Uniquely identify a single testing event for a patient
Uniquely identify all tests of a certain class (e.g. all the same IVD, or the same analyte)
Do so in a manner that is easily extensible
Solution: Support the following elements
Clinical interpretation data elements
e.g. result value, specimen, units, reference ranges
Semantic/ontological data elements and relationships
e.g. Solor, LOINC-on-OWL
Device/manufacturer data elements
e.g. UDI for device, IVD, kit, code assignment
Standardization/harmonization information
Timelines
Problem: Much of the clinical interoperability effort relies on tools that haven’t been built yet, coordination of complex issues between large organizations, and vendor support of standards that haven’t been defined yet
Solution: Approach goals incrementally. Some necessary projects can be started immediately, whereas others will require multiple years for adoption. Even the ones that require years (e.g. vendor functionality) need to be started as soon as possible.
By Year 1:
Define semantic resource solution
Define necessary identifiers and data elements re: LIDR, UDI, standardization/harmonization
Develop LIDR Implementation Help Portal
Flat file and web access to necessary static data sources
Immediately engage vendors on new functionality required
By Year 2:
LIS/EHRs begin to support new features/data elements
Application programming interfaces to necessary static data sources
Authoring tools for LIDR/UDI assignment
By Year 3:
LIS/EHRs complete ability to store and exchange all necessary data elements
Automated lab catalog and data dictionary maintenance tools
Third party search
Laboratory data repository
IVD data hub
Measures
Out of scope. Defer to Effectiveness Committee.