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9-10 Operator’s Manual – OPTI CCA-TS2
9 OPERATING PRINCIPLES
9.5.6 Quality Control
On initial use of each shipment of cassettes, and at 1 month intervals thereafter, validation of the lot
should be performed by analysis of OPTI Medical blood gas, electrolyte, metabolite, tHb and SO
2
controls (OPTI CHECK or OPTI CHECK PLUS). This material should provide target values for all
measured parameters over a range of measurement values typically seen in each laboratory.
The results obtained should fall within limits defined by the day-to-day variability as measured in the
user’s laboratory.
It is recommended to aspirate Quality Control and Proficiency testing material directly from the ampoule.
This procedure helps to minimize sensitivity to pre-analytic and other errors associated with the use of
aqueous controls (see Limitations Section).
The multi-level Standard Reference Cassettes (SRCs) should be used as a control for measurement and
proper analyzer operation. These cassettes can test at 3 levels and OPTI Medical Systems recommends
that SRC measurements should be performed for levels 1 and 3 (high and low values) once each day of
OPTI CCA-TS2 operation. The test cassettes contain a stable optical sensor simulator which is measured
by the device in exactly the same manner as any other cassette and provides assurance that measurement
of all analytes by the device is consistent. The results obtained should fall within limits supplied with the
SRCs. For SRC limit values, see analyte section of this manual.
All specific performance specifications reported in this summary are determined from the above, minimal
recommendations for quality control verification.
The Standard Reference Cassettes are a complemetary method in quality control testing. In traditional
blood gas analyzers, liquid quality control (QC) material is run several times a day to verify the system
measurement, including reagents, used for patient testing. On these systems, multiple patient samples
are run using the same reagent system. On the OPTI CCA-TS2, all reagents needed to run a single patient
measurement are pre-packaged in a single disposable cassette. Each cassette is an individual reagent and
sensor system.
The traditional method of running a liquid QC material several times each day does not check these
individual reagent and sensor systems. Therefore, manufacturers have developed complementary QC
methods to ensure all elements of the system are monitored. OPTI Medical Systems has a two-step
approach. First the SRC, the OPTI CCA-TS2’s electronic/optical simulator, checks the electronics, optics,
thermostats, etc. of the system. Second, when a sample cassette is inserted, it performs an extensive
quality check prior to patient sampling to ensure, among other things, that the reagent system contained
within the cassette is within pre-defined limits. If it is not, an error message occurs and the cassette is
discarded. In addition, automatic checks are performed of packaging integrity, temperature control,
proper fluidic control, bubble detection, etc. This approach provides a quality control check of the system
similar to traditional liquid QC without incurring additional costs to the laboratory.
Every hospital is required to develop its own policies and procedures for quality control checks.
Minimum guidelines are defined by a variety of regulatory agencies. Many agencies have updated their
regulations to incorporate complementary QC methods such as the SRC. Some, however, have not.
For agencies requiring a liquid QC material and for institutions requiring additional QC checks, OPTI
CHECK and OPTI CHECK PLUS are available. These controls are specially formulated aqueous liquid
control materials that contain all analytes measurable by the OPTI CCA-TS2. They contain a stable
suspension of polystyrene micro beads which reflect and partially absorb red and infrared light similarly
to erythrocytes, allowing true measurement of tHb and SO
2
. The three control levels contain three
different concentrations of micro beads to simulate low, medium, and high hemoglobin blood samples.