Users Manual Part 1

Operator’s Manual 9 - 1
9 Using the QC Program
9.1 Overview
Quality Control (QC) consists of strategies and procedures that measure the precision and stability
of the analyzer. The results imply the reliability of the sample results.
QC involves measuring materials with known, stable characteristics at frequent intervals. Analysis
of the results with statistical methods allows the inference that sample results are reliable. Mindray
Animal Medical recommends you run the QC program daily with normal, low and high level
controls.
A new lot of controls should be analyzed in parallel with the current lot prior to their expiration
dates.
This may be accomplished by running the new lot of controls for five days using any empty QC
files. The QC files calculate the mean, standard deviation and coefficient of variation for each
selected parameter. The instrument-calculated means of these ten runs should be within the
expected ranges published by the manufacturer.
9.2 QC
On a QC graph, quality control data is plotted to show whether the instrument is working well.
Laboratories may set up allowable deviations (by standard deviations (SD) or coefficient of
variation (CV%)) from the targets for the control based on their real scenario.QC points are then
plotted so the operators may easily see how far the actual QC results are from their targets. The x-
aixs indicates the QC date and time; and the Y-aixs indicates the targets as well as the defined
limits. Draw a straight line respectively at the reference value position and the upper and lower
deviation limit position of control parameter along the X-axis direction on the QC graph. Lines run
across the graph at the target as well as at the upper and lower limits to either side of the target value
for the control. The QC points' distance from the target value is measured in SD or CV%.
You can select one of the two ways below to run controls:
• Run controls under the “QC” screen.
• Put controls together with normal samples, and run the controls on the “Count” screen
9.2.1 Setting up QC Files (Administrators)
Introduction to the QC File Setup
You can set up QC files on the QC file setup screens.