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A Certificate Program in

Quality Management Systems for Laboratory Leadership

Use of Statistical Concepts to Provide Reliable Test Results

Sherry Martin, MEd. MT(ASCP)SC

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OUTLINE
Description and value of descriptive statistics Calculation of measures of central tendency Calculation of measures of dispersion Difference in meaning of accuracy and precision Use of standard deviation in the calculation of acceptable limits

Session Objectives
Upon completion of this session, participants will be able to: Describe the value of descriptive statistics in method evaluation Compare the meaning and use of accuracy vs precision Calculate measures of central tendency and dispersion Use standard deviation measures to establish acceptable control limits

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Descriptive Statistics
All laboratory test results will have some variation; is the variation acceptable? DS allows us to analyze graphs to look for patterns Patterns can be described by their center (mean), shape and the spread Spread, or dispersion, enables laboratorians to predict the acceptability of the test results

Measures of Central Tendency

Data are frequently distributed about a central value or a central location There are several terms to describe that central location, or the central tendency of a set of data

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Measures of Central Tendency

Median = the value at the center (midpoint)
of the observations

Mode = the value which occurs with the

greatest frequency

Mean = the calculated average of the values

Calculation of the MEAN

Add all the values in the data set and divide by the number of values The mean is represented by a x with a bar over it, known as x bar 5, 4, 6, 5, 3 ,7, 5; total = 35/7 = 5

Mean ( )= 5

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The sum of all data (x) in the set

The number of data points in the set

MEDIAN
Example for an even data set: 5, 4, 6, 8, 9, 7; data set 4, 5, 6, 7, 8, 9; data set rearranged Add the two middle values: 6 + 7 = 13 Divide by two to get the average: 13/2 = 6.5

Median = 6.5

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Calculation of the MEDIAN

Values in the data set are rank ordered from least to greatest and the value in the middle is the Median Example for odd number: 5, 4, 6, 5, 3, 7, 5 data set 3, 4, 5, 5, 5, 6, 7, arranged from least to most

Median = 5

Calculation of the MODE

The most frequently occurring value in dataset 3, 4, 5, 5, 5, 6, 7

Mode = 5 3, 4, 5, 5, 5, 6, 7, 8, 9, 9, 9 Modes = 5 and 9

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Lets Calculate These Measures

Normal distribution
All values symmetrically distributed around the mean Characteristic bellshaped curve The mean, median and mode are the same value
Frequency

Mean, Median Mode

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Accuracy and Precision

The closeness of measurements to the true value is indicative of the accuracy (trueness) of the assay The degree of fluctuation in the measurements is indicative of the precision (repeatability) of the assay. Quality Control is used to monitor both the precision and the accuracy of the assay in order to provide reliable results.

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Precision and Accuracy

Precise and inaccurate Precise and accurate

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Imprecise and inaccurate

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Measures of Spread
Range the largest value in the data set minus the smallest value; represents the extremes of values that one might encounter Standard deviation (SD) represents the average distance from the center of the data and from every value in the data set Coefficient of variation enables laboratorians to compare SDs of different methods

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RANGE
The difference between the highest and lowest data points 5, 4, 6, 5, 3, 7, 5; difference from 7 to 3= 4

Range = 4
Note: It is useful with small data sets but susceptible to extreme values or outliers

STANDARD DEVIATION (s)

It quantifies how close values, such as controls are in relation to each other It is related to the precision of a test Imprecision is used to express how far apart values are from each other A low test s indicates consistent repeatability and low imprecision A high test s may be due to an error and must be corrected by the laboratory

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Standard Deviation A Measure of Dispersion

Calculation of Standard Deviation Mean (average) = = Xi / n = Sum of Xi = individual measurements n = number of measurements

Calculation of the STANDARD DEVIATION

First, calculate the variance (s2) Variance = average of the squared distances of all values from the mean It represents the difference between each value and the AVERAGE of the data

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Calculation of Variance
5, 4, 6, 5, 3, 7, 5; Find the mean; add all values and divide by 7
35/7 = 5 ( mean)

Next subtract the mean from each value

(5 -5) + (4 -5) + (6 5) + (5 5) + (3 5) + (7 5) + (5 5)

Square each value within the parenthesis

(0)2 + (-1)2 + (1)2 + (0)2 + (-2)2 + (2)2 + (0)2

Calculation of Variance (cont)

Add all the square values: 0 + 1 +1 +0 + 4 + 4 +0 = 10 Divide the sum of the squares by the total number of values minus 1 10 (7 1) = 10/6 = 1.67

Variance = 1.67

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STANDARD DEVIATION
To calculate the standard deviation, simply take the square root of the variance Square root of 1.67 = 1.29

Standard Deviation = 1.29

Calculations
Standard Deviation

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COEFFICIENT OF VARIATION
Coefficient of Variation (CV) allows us to compare the SD of different methods and different analytes It is calculated by dividing the SD by the mean and multiplying by 100 to express as % CV = 1.67/5 X 100 = 8.35%

Use of CV FSH LEVELS HCG LEVELS Conc SD CV Conc. SD CV

1 10 100 0.09 0.40 3.8 9.0 4.0 3.8 10 0.8 8.0 5.2 4.9

1,000 52.0
1,00,000 4,897,0

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Statistical Analysis
Very important skill for laboratory personnel Manuel aides:
Graph paper Math tables Calculator physical and virtual

Computer software
Laboratory Information System (LIS) Instrument vender .. Quality Control materials vendor
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Descriptive Statistics Exercise

Using the data sheets provided, calculate:
Mean Median Mode Variance Standard deviation Coefficient of variation

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Use of Standard Deviation

Distribution of Values around the Center
The way in which the values relate to the center determines its shape The Gaussian distribution is known as the Normal distribution It is symmetric, known as the bell curve The mean, median and mode values are the same

The Normal Distribution

Performance Measurement in HIV Care

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How We Calculate Limits of Acceptability

1 s = 68.3% of values from the mean 2s = 95.5% of values from the mean 3s = 99.7% of values from the mean Limits for data acceptability are defined using standard deviation. The range for 1s is calculated: Mean +/- 1s

EXAMPLE
The mean for a LDH test is 117.4 U/LL and the standard deviation is 5.03U/L 1s = 117.4 U/L 5.03 U/L = 112.4 U/L 117.4 U/L + 5.03 U/L = 122.4 U/L The 1s range is: 112.4 122.4 U/L

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EXAMPLE
2S = Mean +/- 2s 11.7.4U/L (2 x 5.03U/L) = 107.3U/L 11.7.4U/L + (2 x 5.03U/L) = 127.5U/L The 2s range is 107.3 to 127.5U/L
Only 4.5% of data should be less than 107U/L or more than 127.5U/L ( 1 in 20 results) Only 0.3% should be less than 102.3U/L (3s) or more than 132.5U/L

What Does All This Mean to Us?

The use of descriptive statistics enables us to determine when an analytical run is acceptable. It is the basis of the quality control system It enables standardization of control practices It saves time and money

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The Quality Control System

Establish allowable statistical limits of variation for each analytic method Establish a systematic process to use these limits as criteria to accept or reject the test results Establish a standardized process to identify the cause(s) of the error and solutions Reanalyze the control and patient data
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SUMMARY
An understanding of descriptive statistics provides the foundation for knowing when to accept or reject a run of test results Defining and calculating measures of tendency enables laboratorians to identify types of errors Understanding the value of applying measures of dispersion, especially standard deviation, enables laboratorians to establish acceptance levels for test results

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