RADIOMETER ABL800 FLEX, Operator'S Manual

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5. Quality control ABL800 FLEX Operator's Manual
General information
Purpose The purpose of quality control is to validate the analyzer’s performance by
evaluating accuracy and precision. Performing quality control routinely will help
to ensure that results from actual patient samples are accurate.
Solutions Each quality control system includes four types of control solutions in order to
provide control of analyzer performance when measuring parameters at low,
normal and high levels – refer to the
Quality control setup in chapter 3 .
It is possible to use non-Radiometer solutions although the accuracy and validity of
the results cannot be guaranteed.
Inserts
Control solutions are packed in ampoule boxes. Each ampoule box contains an
insert with the Radiometer-determined assigned values and control limits valid for
that particular lot of control solutions. The solution type, lot number, assigned
value and expiration date is barcoded for easy entry.
Quality control
frequency Quality control solutions are solutions with predetermined values that cover the
clinically relevant ranges for the measured parameters, the objective being to
simulate a patient sample. Each quality control system from Radiometer includes
four levels of quality control solutions in order to cover the whole clinically
significant range: low, normal and high. The number of levels should cover the
analytical measuring range.
Special country, state and local regulations must be complied with. Additional
quality control should be run after any troubleshooting or preventive maintenance
which might alter performance and whenever the technician has questions about
the performance of the analyzer.
An example of daily routine with the 4-level quality control system is given below:
Shifts per day Quality control routine
3 One level tested at the beginning of each shift. The 4th level
is tested in the 8-hour shift with the highest volume of patient
samples.
2 Two levels at the beginning of each shift.
1 All levels are tested at the beginning of each shift.
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