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Identification of harmonized tests - per this definition = https://www.harmonization.net/measurands/
In Scope Activities: Testing Continuum / Ecosystem
Perspective/ Stakeholder | Milestone Description | Stage/Phase | Notes |
|---|---|---|---|
IVD Vendor | Test Development | ||
IVD Vendor | |||
SDO: LOINC | Create Lab Order & Result LOINCs | ||
IVD Vendor | Create Test LIVD Maps | ||
FDA | 510 (k) Approval | ||
FDA | Pre-Market Assessments / EUA | ||
Lab / LIS | Assay Validation / Interfaces | ||
Lab / LIS | Test (orders and results) build | ||
Lab / LIS | Test Catalog/ Compendium / CLIA Specimen Collection Manual | ||
EHR / Provider | CPOE- Support of Multiple Catalogs (2-5 avg) | ||
EHR / Provider | Lab Order Sender / Expansion (Indiv Patient) | Pre-Analytical | |
Lab / LIS | Lab Order Receiver / Expansion (Indiv Patient) | Analytical | |
Questionable:
Calibration - use of calibration reagents - provide list of “acceptable reagents” of those not yet harmonized to the manufacturers
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