ITC IRMA TruPoint Blood Analysis System - Manual (Page 54)

3.2
IRMA TRUPOINT QUALITY CONTROL
The IRMA TruPoint Quality Control program consists of the following four
elements:
1. Comprehensive, automatic, on-line quality and procedural checks
that continuously monitor sensor response and instrument response. The
IRMA TruPoint software monitors responses throughout both the
calibration and sample analysis phases of a test. If an uncharacteristic
response is detected during the calibration phase, the system rejects the
cartridge and does not allow that cartridge to be used for sample analysis.
Since sample introduction occurs after calibration, rejected cartridges do
not result in the loss of the sample. If an uncharacteristic sensor response
is detected during the sample analysis phase, the system suppresses that
sensor and does not report an analyte result for that sensor.
2. Electronic Quality Control (EQC) is performed through a
comprehensive diagnostic check of the edge connector, internal
electronics, and analyte circuitry. An EQC test simulates the electronic
signals that are produced by IRMA TruPoint sensors during a cartridge
test. During an EQC test, an isolated region of the internal circuit board
sends a range of simulated sensor signals through the cartridge
measurement channels. The range of signals generated encompasses the
entire linear range expected from blood analysis. This measurement is
followed sequentially by measurements of conductivity out to the
connector pins, insuring that no contamination is present in the edge
connector which would interfere with test results. Signal measurements
must fall within strict predetermined thresholds for the test to pass.
IRMA TruPoint EQC is an internal method, and does not require the use
of an external EQC card. Analyzers powered by AC adapter can be
configured to automatically run EQC tests per a preconfigured schedule.
3. Liquid Quality Control (LQC) is performed to verify proper shipping
and cartridge storage conditions using various liquid control solutions of
known analyte concentration. Control materials are commercially
available in levels corresponding to normal and abnormal clinical
conditions.
4. Temperature Test is performed using the IRMA TruPoint Temperature
Card to verify proper operation of the IRMA TruPoint temperature
control system. Although the temperature is monitored continuously
during patient testing, the Temperature Card allow for easy external
verification.