COURSES GROUPS RESOURCES GRADES Sharon …

Clinical Chemistry 2 Laboratory: WTh 4:00 ...   Laboratory Lessons and Activities

Lesson 3: Quality Control and Calculations

Quality Control and Calculations

QUALITY CONTROL AND CALCULATIONS

Learning Outcomes

1. Calculate the mean, standard deviation, variance, coefficient of variation, coefficient of variation rate, and standard deviation index for
an analytical method.
2. Eplain the usefulness of the mean, standard deviation, variance, coefficient of variation, coefficient of variation rate, and standard devi‐
ation index in interpreting quality control results.

Lesson  Discussion

INTRODUCTION

Procedures for quality control are a major part of the Quality Assessment program and are also the most noticeable part of the program. Quality
control (QC) is the process of monitoring laboratory measurements to ensure the accuracy of results. It relates to the tool and procedure designed
to recognize, minimize, and correct deficiencies in the laboratory's internal analytical process. To ensure the reliability of each measurement con‐
ducted on a sample, this is done before the release of any laboratory results.

Quality control in the laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results. Quality
control programs use statistics, the branch of mathematics that deals with collecting classifying, analyzing, and interpreting numerical data. An en‐
tire group or collection of observations is called a population. In laboratory statistics, a subgroup of the population (a group of specimens) is called
sample. The statistics involved in a good QC program can be very complicated, but this lesson will cover the important ones, the most fundamental
statistics of which that are used by the laboratory are the mean and standard deviation.

QC statistics for each test performed in the laboratory are calculated from the QC database collected by regular testing of control products. The
data collected is specific for each level of control. Consequently, the statistics and ranges calculated from this data are also specific for each level of
control and reflect the behavior of the test at specific concentrations.

BASC QUALITY CONTROL STATISTICS

The calculation for mean, variance, and standard deviation for test procedures are the foundation of a laboratory QC program. The mean is the av‐
erage of a set of values. The standard deviation, a measure of the scatter of the sample values around the mean, is derived from the calculation of
the variance, the mean square deviation. Therefore, once the mean of a set of values has been determined, it is possible to determine the accept‐
able variation in the results of that analytical method.

Calculating the Mean

The mean is calculated by finding the sum of all the value in the set and dividing this by the number of values in the set; in other words, by calcu‐
lating the average of a set of numbers. For example, 10 values obtained in repeated analyses of glucose control were: 82, 89, 85, 91, 90, 81, 85,
93 and 89 (mg/dL). The formula for determining the mean is:

÷
 I =

0%-1=87

:#
5 ±

0 = 16

Figure 3.1. Using a set of 10 value to calculate the deviation from the mean and the deviation squared

 
S = if i 4

Substituting the 10 glucose values into the formula, the mean is found to 87:

Calculating the Variance how far each number scatter around the mean .

The variance (s2) is calculated by subtracting each value in the set from the mean, squaring this number, and calculating the sum of the squares. That sum is
then divided by n – 1, which is the number of individual values in the set minus one. The formula for variance is:

An example of how to find the deviation from the mean and the deviation squared shown in Figure 4-1. The values in column two are obtained by
subtracting each value in column one from the mean. Therefore, the first entry in column two is negative (–) 5. This is obtained by subtracting 82,
the first value in column one from the mean, 87. It does not matter if some of the differences are negative numbers, because squaring them makes
them positive numbers. From the example in Figure 4-1, the following substitutions can be made in the variance formula:

Calculating the Standard Deviation

The standard deviation is denoted by s (in italics), or sometimes just SD. The standard deviation (s) is obtained by taking the square root of the variance:

Therefore, the standard deviation (s or 1s) for this glucose mean is 4. Glucose values between 83 and 91 would lie within ±1s of the mean (87). For this partic‐
ular glucose control then 2s = 8, and 3s = 12. These calculations seem complicated, but software in most analyzers includes a program that automatically cal‐
culates statistics from control values.

Coefficient of Variation

When a laboratory changes from one method of analysis to another, the precision of the new method must be compared to that of old one. This
can be done by calculating the coefficient of variation (CV) for each method. The CV is a calculated value that compares the relative variability devi‐
ation as a percentage of the mean.

For example, if a laboratory is purchasing a new blood glucose analyzer, the means and the standard deviation of the controls run on both the old
and new analyzers would be used to calculate the CV for each instrument. Suppose that the mean glucose for the normal control using the first
(old) analyzer is 98.5 mg/dL with a standard deviation (s) of 2.5 mg/dL and the mean glucose control value using the second (new) analyzer is 96
mg/dL with a standard deviation of 2.3 mg/dL. The CV’s for the two methods would be calculated as shown below:
In this comparison, the CVs are about the same, so the precision of the methods is similar. However, if a third analyzer gave a control mean of 95
mg/dL and s of 5.0 mg/dL, the CV would be calculated as follows:

Coefficient of Variation Ratio [CVR]

Although accuracy of test results is paramount in the clinical laboratory, precision is just as important. One way a laboratory can determine whether the
precision of a specific test is acceptable is to compare its precision to that of another laboratory performing the same test on the same instrument using
the same reagents (laboratory peer group).

Figure 3.2. Formula for calculating CVR.

An easy way to make this comparison is to divide the laboratory CV by the laboratory peer group CV obtained from an interlaboratory comparison
report. For example, if the CV for potassium on a particular instrument is 4% and the potassium for all other laboratories using the same instrument is
4.2%, then the coefficient of variation ratio [CVR] is 4/4.2 or 0.95. Any ratio less than 1.0 indicates that precision is better than the peer group. Any
score greater than 1.0 indicates that imprecision is larger. Ratios greater than 1.5 indicate a need to investigate the cause of imprecision and any ratio
of 2.0 or greater usually indicates need for troubleshooting and corrective action. Something in the test system is causing the increased imprecision
and patient test results may not be entirely reliable. Certainly, repeated tests such as glucose for diabetic patients or prothrombin times for patients tak‐
ing coumadin will not be reliable when the imprecision is high.
  

Standard Deviation Index [SDI]

The standard deviation index [SDI] is a peer-based estimate of reliability. If the peer group mean is defined as xGroup , the standard deviation is defined
as sGroup and the laboratory’s mean is defined as xLab .

Figure 4.3. Formula for calculating SDI.

The target SDI is 0.0 which indicates a perfect comparison with the peer group. The following guidelines may be used with SDI. A value of:
1.25 or less is considered acceptable.
1.25 – 1.49 is considered acceptable to marginal performance. Some investigation of the test system may be required.
1.5 – 1.99 is considered marginal performance and investigation of the test system is recommended.
2.0 or greater is generally considered to be unacceptable performance and remedial action is usually required.

Laboratory Activity

For today's laboratory activity, you are to:

Answer the post-laboratory write-up form →QC write up form (also found in the write up folder) and submit on or before 7:00 pm
today.
A graded quiz on this laboratory activity and the lesson discussed above will be given next meeting.