PURPOSE OF TEST
The iSTAT 1 analyzer is intended for use in approved Point of Care locations. With the iSTAT 1 System, the FDA has categorized the Glucose Cartridge as a Non-Waived Complex Test when testing is performed using arterial, venous, and capillary whole blood samples. The test for glucose, as part of the i-STAT System, is intended for use in the in vitro quantification of glucose in arterial, venous, or capillary whole blood. Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
POLICY
SUPPLIES
iStat Glucose Testing Supplies PENDING
MANUFACTURER’S INFORMATION
iStat Calibration Verification
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 – 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)