Operator’s Manual – OPTI CCA-TS2
4-3
4 CALIBRATION AND QUALITY CONTROL
4.4 Calibration Verification
Calibration verification allows for the validation of the blood gas analyzer’s ability to recover
known values at various points within the reportable range of all parameters and may be required
by various regulatory agencies.
The OPTI CCA-TS2 Analyte Section, included in the back section of this manual, provides
precision and recovery data for all the measured parameters in the ranges that are usually
encountered in the diagnostic testing of patients.
A calibration verification kit is available from OPTI Medical for all parameters except tHb and
SO
2
. For calibration verification of tHb and SO
2
, OPTI Medical recommends testing whole blood
against a reference analyzer.
4.5 QC Recommendations
The multi-level Standard Reference Cassette (SRC) should be used as a control for the OPTI
CCA-TS2 analyzer. The SRC contains a stable optical sensor simulator which is measured by
the device in exactly the same manner as any other cassette and provides assurance that all
parameters measured by the analyzer are consistent. The OPTI will subject the SRC sensors to
different levels of light to simulate low, normal and high patient measurements. Level 1 and level
3 represent high and low samples and are the system default settings based on the OPTI Medical
QC recommendations. The results obtained should fall within limits contained in the SRC
barcode.
NOTE: Hospitals should develop their own policy and procedures on the number of QC samples
to be run on a daily basis as mandated by the regulatory agency under which they
operate.
After receipt of a shipment of cassettes and at monthly intervals thereafter, validation should be
performed by analysis of OPTI CHECK or OPTI CHECK PLUS Blood Gas Controls. These
materials should provide target values for all measured parameters over a range of measurement
values typically seen in each testing site laboratory. The results obtained should fall within limits
defined by the day-to-day variability as measured in the user’s laboratory facility.
OPTI Medical recommends the following as a minimum testing frequency of QC materials:
Control
Frequency
SRC levels 1 and 3
At least 1x per day in operation
OPTI Check or OPTI Check Plus Liquid
Controls
1 month intervals and with each new shipment
of cassettes.