PURPOSE OF TEST
The Accu-Chek INFORM II meter is considered a waived test by the FDA used to obtain rapid assessment of blood glucose concentration results at the point of care. The test is to be used for monitoring glucose levels and should not be used for diagnosis.
POLICY
SUPPLIES
MANUFACTURER’S INFORMATION
Control Solution Package Insert
MEMOS
Lancets – Single Use Only – September 2010
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)