Roche OMNI C, Instructions For Use Manual

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5 Quality control
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
5-1
5 Quality control
If QC measurements are not performed or only incomplete or the QC measurement
is ignored, it can lead to incorrect measurement results, which may lead to incorrect
clinical decisions.
Danger of personal injuries!
5.1 General QC concept
Roche Diagnostics always strives to ensure the highest quality standards for its products.
This quality awareness is the result of a sense of responsibility toward the customer and the
well-being of the patient.
The quality control is an important element of this claim. Aqueous blood gas/electrolyte QC
materials, such as COMBITROL, AUTO-TROL, etc., are offered to ensure that the Roche
OMNI C provides measurements of high quality to protect customers or its patients.
In order to ensure the quality of the measurement results, complete a quality control test on
3 levels (low, normal, high) after each electrode exchange and after startup of the instru-
ment at least once daily or more often in accordance with local regulations. A quality con-
trol program for blood gas, electrolytes and tHb/SO
2
includes the analysis of sample mate-
rials with known ranges of expected values and the comparison of these values with analyzer
results.
The following control material is recommended:
•
COMBITROL TS
• AUTO-TROL TS
The target areas listed in the package text should be taken as 2
σ
areas (
σ
= standard devia-
tion) (e.g. for P O
2
, 2
σ
= 12 mmHg, 1
σ
= 6 mmHg).
The QC measurement results within the target value range ± 2
σ
are perfect.
If QC measurement results fall outside the target value range ± 3
σ
, the parameter must be
blocked!
QC measurement results that are greater than the target value ± 2
σ
, but smaller than the
target value ± 3
σ
, lead to a QC warning and must be dealt with separately.