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Detailed Description

  • IV&V on harmonized terminology

  • Quality Assurance on knowledge representations

  • Knowledge can be reliably represented but how do we mitigate “bad” knowledge

Supporting Tactics

Tactic

Impact

Reference Standard/Harmonization Hub

Contains information on what analytes have a traceable standard or harmonization procedure.

Laboratory testing QC data repository

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

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

National database of testing data allowing performance monitoring of IVD and device-related issues. With linkages, could be used in evidence generation.

Supporting Use Cases

Use Case

Run APIs or other computational processes (idempotent) against the latest terminology release to assure no typographical errors in codes or displays.

Check against current date to learn if this is the correct version release.

Key Initiatives & Action Items

Deliverables