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Tool

Tool Type

Strategy

Description

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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