ITC IRMA TruPoint Blood Analysis System - Manual (Page 55)

3.3
QUALITY CONTROL
RECOMMENDATION
Following method verification and establishment of liquid quality control
limits, ITC recommends EQC as the primary method of assessing system
accuracy and precision. Since each test site may have unique requirements,
each site should select and verify a quality control system that meets their
needs. ITC recommends that QC be performed as follows:
RUN AN EQC TEST:
• Once per shift of patient testing on each analyzer;
• When the analyzer experiences a significant change in storage
temperature, (e.g., movement from a cold to a hot environment);
• Whenever the performance of the analyzer requires verification, according
to facility or regulatory agency protocol.
RUN TWO LEVELS OF LIQUID CONTROL:
• Before a new cartridge lot or shipment is put into use, (following the
required equilibration period) to verify proper shipping and equilibration
conditions. Cartridge lot verification is not required for each analyzer in
use.
ADDITIONAL LIQUID CONTROL TESTING:
• Is required only if cartridges are required to go through an additional
equilibration period due to temperature fluctuations of greater than 8°C
(14.4°F) in the cartridge storage area. Refer to Section 1-Cartridge
Equilibration Procedure for additional equilibration information.
• If cartridges are required to go through an additional equilibration period,
run two levels of liquid control before putting the cartridge lot back into
use.
RUN A TEMPERATURE TEST:
• Monthly to verify that the IRMA TruPoint temperature control system is
operating properly.