ITC IRMA TruPoint Blood Analysis System - Manual (Page 111)

7.15
QUALITY CONTROL (QC)
SETTINGS
QA Users can access QC Settings by pressing QC from the SETTING
OPTIONS menu. The following options are presented:
Menu: Returns to main MENU.
Settings: Returns to SETTING OPTIONS
menu.
QC Lockout: Allows definition of the number of
electronic (EQC) and/or liquid
(LQC) quality control tests required to support patient testing.
Controls: Allows set-up of new controls and editing or deletion of
established controls for IRMA TruPoint cartridge and
SureStepPro Glucose Module tests. If the glucose module is in
use, refer to the SureStepPro Glucose Module User Manual for
details.
QC LOCKOUT
QA Users can designate the number of QC tests (electronic and/or liquid QC)
required to support patient testing. Separate QC lockout schedules may be
established for each product type and analyte or analyte group. When QC
Lockout is activated, either 1, 2, or 3 successful quality control tests must be
run during a shift or the analyzer will deny access to the patient test screen.
Shifts can be specified as 8-, 12-, or 24- hours in length.
Example: An 8 hour shift length and one EQC tests per shift is defined. A 1
hour grace period is provided at the start of each shift in which the patient test
screens may be accessed even if QC requirements have not been met. If the
shift begins at 7 a.m., the grace period is from 7-8 a.m. After the grace period,
patient test screens cannot be accessed until a successful EQC test has been
run. QC must be run after the shift start time established in the set-up (in this
example, 7 a.m.) to count toward satisfying the QC Lockout requirement.
Shift times are based on the analyzer’s internal clock.
General QC lockout rules
• When EQC Lockout is on, an EQC test failure at any time (i.e., even if
EQC passed earlier on the same shift) will lockout patient testing.
Following an EQC test failure, a passed EQC test is required to resume
patient testing.
• When liquid QC limits have been established, results must fall within the
established QC limits to be considered a successful test and satisfy QC
lockout requirements.