Description
Select this binder if you plan on testing simple “waived” tests classified by the FDA. These are simple laboratory tests that have an insignificant risk of an erroneous result and carry a low clinical significance.
- HIPAA Overview
- Incident Management Plan
- FDA Medical Device
- General maintenance overview
- Safety program
- Specimen labeling/collection/rejection
- Staff Orientation
- Control procedure: QC for waived kit testing
- Temperature, specimen, rejection, reagent kit log
