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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, knowledge bases 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. |
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