PURPOSE OF TEST
This procedure is to detect patients with renal failure who might be harmed by intravenous contrast media used for imaging procedures. The iSTAT 1 analyzer is intended for use in approved Point of Care locations. With the iSTAT 1 System, the FDA has categorized the Creatinine Cartridge as a Waived Complexity Test when testing is performed using venous whole blood samples collected in sodium or lithium heparin evacuated tubes only.
POLICY
SUPPLIES
MANUFACTURER’S INFORMATION
IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions)
INITIAL ORIENTATION, TRAINING & COMPETENCY
Initial Orientation & Training – This must be completed (once) with all new staff trained to use this test.
Competency Test Basic User – This must be completed by all testing personnel 1) After initial training and before technical duties are performed; 2) 6 months after initial training (California Law); and 3) annually thereafter.
Competency Test Super User – This must be completed by all testing personnel 1) After initial training and before technical duties are performed; 2) 6 months after initial training (California Law); and 3) annually thereafter.
QUALITY CONTROL
SAFETY DATA SHEETS (SDS)