Roche 9180 - General QC Concept; Quality Control

Roche Diagnostics
Instructions for Use · Version 10.0 119
9180 Electrolyte Analyzer 8 Quality control
Quality control
Quality control
WARNING
Failure to follow QC protocols or ignoring QC results may lead to incorrect patient
results
Failure to follow QC protocols or ignoring QC results may lead to incorrect patient results,
which may endanger patient lives.
r Follow quality control practices according to local regulations.
r Perform a minimum of one QC measurement each day. In addition, alternate through
the 3 levels of available QC materials over the course of 3 days. For example, perform a
QC measurement on day 1 with a level 1 QC material, on day 2 with a level 2 QC
material and on day 3 with a level 3 QC material.
r Perform QC tests on 3 levels after each of these actions: electrode replacement,
SnapPak replacement, start-up of the analyzer, pump tubing set replacement, main
tubing harness replacement, sample probe and fill port replacement, and cleaning of
the reference electrode housing
r If QC results do not match their expected results, perform the QC measurements again.
If QC results still do not to match their expected results, contact Roche Technical
Support.
r Do not use the analyzer for diagnostic purposes until QC results match their expected
results.
General QC concept
Roche offers an aqueous QC material called ISETROL that should be used to ensure
that the 9180 Electrolyte Analyzer provides measurements of high quality in order
to protect patients.
In order to ensure the quality of the measurement results, complete a quality control
test on three levels (1=low, 2=normal, 3=high) after each electrode exchange, after
each replacement of the SnapPak, after startup of the instrument as well as after
monthly, semi-annual and annual maintenance steps.
Additionally, at least one daily QC measurement has to be performed in alternating
levels (1=low, 2=normal, 3=high) (e.g., day 1 - level 1, day 2 - level 2, day 3 - level 3,
day 4 - level 1, etc.). When required by local regulations, QC measurements have to
be performed more often.
A quality control program for electrolytes includes the analysis of sample materials
with known ranges of expected values and the comparison of these values with
analyzer results.
Use the following control material:
o ISETROL
The target values listed in the package insert sheet should be taken as 2 SD values (SD
= standard deviation).
The QC measurement results within the target value range ± 2SD are acceptable.
If QC measurement results fall outside the target value range ± 3SD, the parameter
should not be used for further measurements!
QC measurement results that are greater than the target value ± 2SD, but less than
the target value ± 3SD, should be treated accordingly.