The basic quality control statistics

Statistical Calculations
• The mean (X) is the sum of the control observations (x1, x2, ...
xi) divided by the number (n) of observations:

• Practice calculating the mean of the following five results: 45,

44, 45, 48, 39
(n 5). (45 44 45 48 39)/5 221/5 44.2
• The standard deviation (SD or s) is the measure of the
dispersion of a group of values around the mean. It is derived
from the curve of normal distribution. It is used to assess
precision.

• Practice calculating the SD of the following results: 45, 44, 45,

48, 39 (n 5).
SD (s) = 3.3
 Standard Deviation (SD)
• It is the commonly used measure of dispersion
• Gives a measurement of dispersion around
the mean
• Calculation:
– X±1SD includes 68% observations
– X±2SD includes 95% observations
– The higher the SD, the more the observation
varies (deviates) from the mean.
 Percentage Coefficient of Variation
(%CV)

• Measures level of imprecision

• Assess the reliability of a given method based on
preset values

S tan dard Deviation

% CV = 100
Mean
 Gaussian Probability Distribution
• It is very important in statistics
• When the distribution of values around the
mean are plotted graphically and are
symmetrical this is referred to as a Gaussian
curve.
• Statistical procedures are based on Gaussian
probability distribution.
 How Are These Values Used?
• Mean and SD are calculations that assess the
accuracy and precision of the analysis statistically.
• Errors of accuracy may be assessed by examining
changes in the measured concentration of the
control over time and comparing these concentration
values to mean and SD ranges of the control.
• By contrast, an imprecision problem will be
demonstrated by an increase in the SD and %CV of
results of the control concentration over time.
 General Principles Of Control Charts

• Control charts are simple graphical displays in

which the observed values are plotted versus
the time when the observations are made.
• The control limits are calculated from the mean
(x) and standard deviations (s)
• The most commonly used charts indicate day
or run number on the X-axis and observed QC
concentration, indicating mean, and SD ranges
on the Y-axis
• One example of a QC chart is the Levey-
Jennings control chart.
• By plotting the daily QC results, one can
visualize the deviation of the results from the
mean, typically noting when the results are
greater than 2 SD from the mean on a daily
basis.
 Control Rules
• The criteria used to determine acceptability
of each control measurement are termed
control rules, or QC rules.
• Westgard defined QC rules based on the
earlier work of Shewhart, Levey, and
Jennings.
• Use of multiple control rules (commonly
referred to as Westgard rules) can improve
the performance of the control system.
 Control Rules
• Individual rules have different capabilities for
detecting different types of analytical error.
• A control rule or control decision is used to judge
whether analysis is performing well.
• Ranges can be tighter if clinical requirements are
more demanding, but the SD limit should not be
set so narrow that excessive time and resources
are wasted checking false rejections.
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15
 Errors in Laboratory Testing

• Random or Systematic
• Random Errors – cannot be absolutely
identified (Ex. Differences in techniques
between workers, specimen characteristics,
etc.)
• Systematic Errors – variation that may make
results consistently higher or lower than the
mean value for a control (Ex. Trouble with the
instrument, deteriorated reagents, etc.)
QC can be achieved through:
• Internal Quality Control (IQC)
• External Quality Assessment (EQA)
 Internal Quality Control Program

• An internal quality control program depend on

the use of internal quality control (IQC)
specimens, LJ Control Charts, and the use of
statistical methods for interpretation.
 Impact of Internal Quality Control
• Continuous detection and rectification of the
Analytical Process.
– Reagent-Equipment-Personnel-Specimen
– Ensure the degree of both precision & accuracy of
your results
– Assure the quality and clinical applicability of your
laboratory reports
– Generate objective evidence of your analytical
performance.
 External Quality Assessment (EQA)

“A program in which multiple samples are

periodically sent to members of a group of
laboratories for analysis and/or identification;
whereby each laboratory’s results are compared with
those of other laboratories in the group and/or with
an assigned value, and reported to the participating
laboratories and others.”
 External Quality Assessment (EQA)
• Inter laboratory
• Complimentary to IQC
• Maintain the long-term accuracy of the
analytical process.
 Impact of External Quality
Assessment
• Continuous quality improvement
• Independent laboratory audit
• Objective evidence of a laboratory analytical
performance
• Assess the results which the laboratory
delivers
• Encourages the search for the root cause of
unacceptable performance.
 Postanalytical Factors
• Postanalytical factors are also important
aspects of testing and primarily deal with
reporting of results and other aspects that
occur after the analysis phase.
• Just as the other two phases of testing have
an effect upon the quality of laboratory test
results, so does the report.
 Postanalytical Factors
• If they are not delivered legibly and in a timely
manner and are not positively identified with the
patient sample, laboratory results are not valid no
matter how carefully preanalytical and analytical
errors were avoided.
• Postanalytical factors include comparing the patient
results to the correct reference ranges as well as
taking into consideration abnormal results that
correlate with critical situations.