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Lecture 7 Control

Laboratory quality management system For medical students

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Luciefer Altonia
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5 views

Lecture 7 Control

Laboratory quality management system For medical students

Uploaded by

Luciefer Altonia
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 26

This lecture will cover the topics.

1. Control materials,
2. Establishing the value range for the
control material.
3. Graphically representing control
ranges

Including in Syllabus.
Control materials
 Controls are substances that contain an established amount of the substance being tested
—the analyte. Controls are tested at the same time and in the same way as patient
samples. The purpose of the control is to validate the reliability of the test
system and evaluate the operator’s performance and environmental conditions
that might impact results.

 Differentiating controls and calibrators: It is important not to confuse


calibrators and control materials. Calibrators are solutions with a specified defined
concentration that are used to set or calibrate an instrument, kit, or system before
testing is begun. Calibrators are often provided by the manufacturer of an instrument.
They should not be used as controls since they are used to set the instrument. Calibrators
are sometimes called standards, but the term calibrator is preferred.
Characteristics of control materials: Some important characteristics to

consider when making the selection are:

 Controls must be appropriate for the targeted diagnostic test—the substance being

measured in the test must be present in the control in a measurable form.

 The amount of the analyte present in the controls should be close to the medical

decision points of the test; this means that controls should check both low values

and high values.

 Controls should have the same matrix as patient samples; this usually means that

the controls are serum based, but they may also be based on plasma, urine or

other materials.
Types and sources of control material:

Control materials are available in a variety of forms. They may be frozen,


freezedried or chemically preserved. The freeze-dried or lyophilized materials must
be reconstituted, requiring great care in pipetting in order to ensure the correct
concentration of the analyte.

 Control materials may be purchased, obtained from a central or reference


laboratory, or made in-house by pooling sera from different patients

 Purchased controls may be either assayed or unassayed.

What is the difference???


 Assayed controls have a predetermined target value, established
by the manufacturer.

Assayed controls are more expensive to purchase than unassayed


controls.

 Unassayed control (or “in-house” controls), the laboratory must


establish the target value of the analyte.

The use of in-house controls requires resources to perform validation


and testing steps. An advantage is that the laboratory can produce very
large volumes with exact specifications.
freeze-dried or lyophilized
 Remember that QC materials are usually serum based.
Universal precautions should be used when handling.
Choosing controls: When choosing controls for a particular
method, select values that cover medical decision points, such as
one with a normal value, and one that is either high or low, but in
the medically significant range.
Controls are usually available in "high", "normal" and "low"
ranges
Shown in the graphic are normal, abnormal high and
low, and critical high and low ranges
Preparing and storing control
material
When preparing and storing QC materials,
it is important to carefully adhere to the
manufacturer’s instructions for
reconstituting and storage. If in-house
control material is used, freeze aliquots
and place in the freezer so that a small
amount can be thawed and used daily. Do
not thaw and refreeze control material.
Monitor and maintain freezer temperatures
to avoid degradation of the analyte in any
frozen control material
Establishing the value range for the control
material

 Assaying control over time: Once the appropriate control materials are
purchased or prepared, the next step is to determine the range of
acceptable values for the control material. This will be used to let the
laboratory know if the test run is “in control” or if the control values are
not reading properly—“out of control”. This is done by assaying the
control material repeatedly over time. At least 20 data points must be
collected over a 20–30-day period. When collecting this data, be sure to
include any procedural variation that occurs in the daily runs; for example,
if different testing personnel normally do the analysis, all of them should
collect part of the data.
 Once the data is collected, the laboratory will need to calculate
the mean and standard deviation of the results. A
characteristic of repeated measurements is that there is
a degree of variation. Variation may be due to operator
technique, environmental conditions or the performance
characteristics of an instrument. Some variation is normal, even
when all of the factors listed above are controlled. The standard
deviation gives a measure of the variation.

 One of the goals of a QC programme is to differentiate


between normal variation and errors
Characteristics of repeated measures:
The variability of repeated measurements will be distributed around a
central point or location. This characteristic of repeated measurements is
known as central tendency.
The three measures of central tendency are:
Mode — the number that occurs most frequently.
Median — the central point of the values when they are arranged in
numerical sequence.
Mean — the arithmetic average of results. The mean is the most
commonly used measure of central tendency used in laboratory QC.
Statistical notations: Statistical notations are symbols used in
mathematical formulas to calculate statistical measures thats important to
know are:

∑ the sum of
N number of data points (results or observations)
X1 individual result
X1 – Xn data point 1– n where n is the last result
X the symbol for the mean
√ the square root of the data.
 Mean :
 Before calculating QC ranges:
The purpose of obtaining 20 data points by running the QC sample is to
quantify normal variation and establish ranges for QC samples. Use
the results of these measurements to establish QC ranges for testing.
If one or two data points appear to be too high or low for the set of data,
they should not be included when calculating QC ranges. They are called
“outliers”.
 If there are more than 2 outliers in the 20 data points, there is a problem
with the data and it should not be used.
 Identify and resolve the problem and repeat the data collection.
 Normal distribution: If many
measurements are taken, and the
results are plotted on a graph, the
values form a bell-shaped curve as
the results vary around the mean.
This is called a normal distribution
(also termed Gaussian distribution).

The distribution can be seen if data


points are plotted on the x-axis and the
frequency with which they occur on the
y-axis.
 Accuracy and precision : If a measurement is repeated many
times, the result is a mean that is very close to the true mean.
 Accuracy is the closeness of a measurement to its true value.
 Precision is the amount of variation in the measurements.
 The less variation a set of measurements has, the more precise it is.
 Bias is the difference between the expectation of a test result
and an accepted reference method.
The reliability of a method is judged in terms of accuracy and
precision.
The purpose of quality control is to monitor the accuracy and precision
of laboratory assays before releasing patient results.

Measures of variability: The methods used in clinical laboratories may show


different variations about the mean; hence, some are more precise than others.
To determine the acceptable variation, the laboratory must compute the standard
deviation (SD) of the 20 control values. This is important because a characteristic
of the normal distribution is that, when measurements are normally distributed:
 68.3% of the values will fall within –1 SD and +1 SD of the mean.
 95.5% fall within –2 SD and +2 SD.
 99.7% fall between –3 SD and +3 SD of the mean.

Once the mean and SD are computed for a set of measurements, a QC


material that is examined along with patients' samples should fall within
these ranges.
Standard deviation: SD is a measurement of variation in a set of results. It is very useful to the
laboratory in analyzing QC results.
The formula for calculating standard deviation is:

The number of independent data points (values) in a data set are represented by “n”. Calculating
the mean reduces the number of independent data points to n – 1. Dividing by n –1 reduces bias.

∑ the sum of
n number of data points (results or observations)
X1 individual result
X1 – Xn data point 1– n where n is the last result
X the symbol for the mean
√ the square root of the data.
Calculating acceptable limits for the control : The values of the
mean, as well as the values of + 1, 2 and 3 SDs are needed to develop
the chart used to plot the daily control values.
 To calculate 2 SDs, multiply the SD by 2 then add and subtract each
result from the mean.
 To calculate 3 SDs, multiply the SD by 3, then add and subtract each
result from the mean.
For any given data point, 68.3% of values will fall between + 1 SD,
95.5% between + 2 SD and 99.7% between + 3 SD of the mean.
When only one control is used, we consider an examination run to be
“in control” if a value is within 2 SD of the mean.
 Coefficient of variation :
The coefficient of variation (CV) is the SD expressed as a percentage of the
mean.

The CV is used to monitor precision. When a laboratory changes from


one method of analysis to another, the CV is one of the elements that
can be used to compare the precision of the methods. Ideally, the value of
the CV should be less than 5%.
Graphically representing control
ranges:
Using graphs for analysis and monitoring: Once the appropriate
range of control values has been established, the laboratory will find it very
useful to represent the range graphically for the purpose of daily monitoring.
The common method for this graphing is the use of Levey–Jennings
charts.
Developing data for Levey– Jennings charts: In order to develop
Levey–Jennings charts for daily use in the laboratory, the first step is the
calculation of the mean and SD of a set of 20 control values as already
explained.
Levey–Jennings chart: A Levey–Jennings chart can then be drawn, showing
the mean value as well as + 1, 2, and 3 SD. The mean is shown by drawing a
line horizontally in the middle of the graph and the SD are marked off at
appropriate intervals and lines drawn horizontally on the graph, as shown below.
This Levey–Jennings chart was developed using 20 repeated measurements
of the control value. In order to use the Levey–Jennings chart to record and
monitor daily control values, label the x-axis with days, runs, or other
intervals used to run QC. Label the chart with the name of the test and the
lot number of the control being used.

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