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QC - The Calculations

Written by James O. Westgard, Ph.D..

This lesson discusses the math involved with QC practice. Despite the age of computers, we
still have to crunch the numbers ourselves sometimes. Dr. Westgard discusses the terms
Mean, SD, CV, Control Limits, z-scores and SDI's, explaining what they are, giving the
equations, and demonstrating how to calculate them.

What calculations?!
Mean, SD, CV
Control Limits
Cumulative or lot-to-date calculations
Z-scores, SDI's protected by reCAPTCHA
-
Privacy - Terms

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Are any calculations necessary if the control material has an assay sheet that lists the range
of acceptable values for my method?
Yes, you still need to collect your own control measurements and calculate the control limits that
apply in your own laboratory. Values and limits found on assay sheets often describe the performance
observed by a specific method in several different laboratories, which means that the figures are likely
to include variations that occur between laboratories. Therefore, those limits are likely to be too wide
for an individual method in your laboratory. If the control limits are too wide, you won't be able to
detect problems in your own laboratory.

Note that US CLIA regulations require that the laboratory determine it's own mean and standard
deviation. [493.1218(5d) "When calibration or control materials are used, statistical parameters (e.g.,
mean and standard deviation) for each lot number of calibration material and each lot of control
material must be determined through repetitive testing."]

What statistics need to be calculated to establish my own control limits? You need to calculate the
mean and standard deviation from the control results that have been collected for each control
material. It's also common to express the standard deviation in percent by calculating a coefficent of
variation, or CV.

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How many control measurements should be collected before making these calculations?

The rule of thumb is to collect at least 20 measurements over at least 2 weeks or 10 working days,
and preferably over at least 4 weeks or 20 working days. You do this by including control materials as
part of your daily work for a long enough period to observe the variation expected in your laboratory.
Too short a period leads to too small an estimate of the standard deviation. Longer is usually better
because the estimates will include more operators and more method changes, such as pre and post
maintenance performance, changes in reagent lot numbers, sample probes or pipettes, etc., thus
even one month might be too short a period. In practice, calculations of the mean and standard
deviation are often made monthly and then the monthly data are added to data from previous months
to calculate the cumulative or lot-to-date mean and standard deviation that are then used for setting
control limits. These cumulative or lot-to-date control limits are a better representation of long term
test performance.

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Control results should have at least one more significant figure than the values reported for patient
test results in order to get good estimates of the mean and standard deviation and to be able to set
appropriate control limits. With some instrument systems where test results are rounded for clinical
significance, only whole numbers end up being reported for control results, thereby giving a discrete
 distribution of control values with only a few possible results, rather than the continuous gaussian
distribution that is expected. This may lead to some practical problems in setting control limits
because the calculated control limits may not correspond to the discrete integer values being
reported.

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The mean is determined by adding a group of measured values, then dividing the total by the number
of measurements in the group. This is often written as:

where the mean may be symbolized by, an x with a bar over it (hence the term x-bar), xi represents
an individual measurement, represents the operation of summation or addition of all these xi values,
and n is the number of xi values in the group. Using just 3 numbers for an example (which is not
sufficent data according to the current laboratory practice of obtaining a minimum of 20 results), for
the values of 100, 105, and 98, xi is the total of these three or 303, and the mean or average is
303/3 or 101.

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Hand held calculators can be used to easily calculate the total of a group of measurements, then
divide that total by the number of measurements included. Scientific calculators usually have a built-in
program for both the mean and standard deviation. Electronic spreadsheets, such as Lotus 1-2-3 and
Excel, usually have built-in functions for calculating the mean and standard deviation from a column
of data. Statistical programs, such as Minitab, SPSS, SAS, and Systat have functions for calculating
the mean and standard deviation, as well as describing the population in terms of the observed
median, mode, range, lowest value, highest value, etc.

In most laboratories, the QC program in the laboratory computer system will calculate the control data
captured on-line or through manual entry. The QC programs incorporated in instrument systems and
some Point-of-Care devices have similar capabilities. Stand alone QC programs on personal
computers are also available and offer complete support for calculations, graphic displays of control
charts, and storage of results. Participants in external survey programs offered by instrument or
control manufacturers can also submit their control data for analysis by the vendors, though the data
analysis may require up to a month for return of the results.

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 The mean value for a control material provides an estimate of the central tendency of the distribution
that is expected if method performance remains stable. Any change in accuracy, such as a
systematic shift or drift, would be reflected in a change in the mean value of the control, which would
be shown by a shift or drift of the distribution of control results. Always keep in mind that the mean is
related to accuracy or systematic error and the standard deviation is related to precision or random
error. See QC - The Idea for a review of how the mean of the distribution of control results is related
to the mean and control limits on a control chart.

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The standard deviation is determined by first calculating the mean, then taking the difference of each
control result from the mean, squaring that difference, dividing by n-1, then taking the square root. All
these operations are implied in the following equation:

where s represents the standard deviation, means summation of all the (xi - )2 values, xi is an
individual control result, is the mean of the control results, and n is the total number of control
results included in the group.

For computerized calculations and for estimating the cumulative standard deviation, the form of the
equation that is commonly used is:

where xi2 is the summation of all the squared individual values, and ( xi)2 is the square of the sum
of all the individual values.

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It is easy to use a scientific calculator, an electronic spreadsheet, or a statistics program, all of which
have built-in functions for calculating the standard deviation of a group of measurements. This
function for calculating the standard deviation is often labeled "SD". Specialized QC software in
laboratory information systems, instruments, and personal computer workstations will automatically
calculate the standard deviation for the data being accumulated. External quality assessment
programs offered by manufacturers of instruments and control materials will also process the data of
participants and provide reports that include the calculated results.

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 The standard
deviation is related
to the spread or
distribution of
control results about
the expected mean.
Whereas the mean
is an indicator of
central tendency
and therefore
related to accuracy
or systematic error,
the standard
deviation is a
measure of the width of the distribution and is related to imprecision or random error. The bigger the
standard deviation, the wider the distribution, the greater the random error, and the poorer the
precision of the method; the smaller the standard deviation, the narrower and sharper the distribution,
the smaller the random error, and the better the precision of the method.

For a measurement procedure, it is generally expected that the distribution of control results will be
normal or gaussian, as shown above. For a gaussian distribution, the percentage of results that are
expected with certain limits can be predicted. For example, for control results that fit a gaussian
distribution, it would be expected that 68.2% of the observed results will be within plus/minus 1s of
the mean; 95.5% within plus/minus 2s of the mean, and 99.7% within plus/minus 3s of the mean.

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CV refers to the "coefficient of variation," which describes the standard deviation as a percentage of
the mean, as shown in the following equation:

CV = (s/ )100
where s is the standard deviation, is the mean, and the multiplier of 100 is used to convert the s/
ratio to a percentage.

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The standard deviation of a method often changes with concentration, i.e., the larger the
concentration, the larger the standard deviation, therefore it is usually necessary to estimate the
standard deviation at the concentration level of interest. Because the CV reflects a ratio of the
:
 standard deviation to the concentration, it is often provides a better estimate of method performance
over a range of concentrations.

For example, you may be interested in planning a QC procedure on the basis of the performance
needed at a critical decision concentration of 200 mg/dL, but the nearest control available has a mean
of 190 mg/dL. Therefore, it is best to calculate the CV from the observed results at 190 mg/dL, then
apply that CV to the 200 mg/dL decision level. This is the reason that QC planning applications with
the QC Validator program use a percentage figure for the imprecision of the method.

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Given the mean and standard deviation for a control material, control limits are calculated as the
mean plus and minus a certain multiple of the standard deviation, such as 2s or 3s. For cholesterol
where a control material has a mean of 200 mg/dL and a standard deviation of 4 mg/dL, the 2s
control limits would be 192 and 208 mg/dL, and the 3s control limits would be 188 and 212 mg/dL.

See a web-based Control Limit calculator in the lesson, QC - The Levey-Jennings Chart
(/lesson12.htm)

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As a rule of thumb, the control results and the calculated standard deviation should have at least one
more significant figure than needed for clinical significance of the patient test result; the mean of a
control material should include at least two more significant figures than needed for clinical
signficance of the patient test result. When in doubt, carry more significant figures than necessary
and round at the end when the control limits have been calculated. Most calculators and computers
carry plenty of extra figures so you can round at the end.

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Typically, control results are summarized by calculating the mean, standard deviation, CV, and N on a
monthly basis. In order to establish longer term estimates of the mean and standard deviation, the
control data or calculated results need to be accumulated to describe performance observed over a
longer periods of time. Longer term limits are often described as "cumulative limits," which indicates
:
 they have been calculated from cumulative means and standard deviations. These may also be
referred to as "lot to date" limits when these calculated values are provided by a manufacturer or
supplier who processes the control data for a group of laboratories in order to provide information
about the comparative performance between laboratories and between methods.

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This is a long term estimate of a method's precision performance based on a large number of control
measurements collected over a long period of time. A long period here is at least two months and
could be several months, even a year.

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These calculations are often automatically performed by the QC programs in laboratory computer
systems, personal computer work stations, and in many automated instruments and even some point-
of-care devices.

If you need to perform these calculations yourself, one practical approach is to calculate monthly
statistics, then tabulate the month n's, xi and xi2, which can then be totaled and used in the
equation below to provide the cumulative estimate:

where nt( xi)t2 is the total of the sums of all the squared individual values, and ( xi)t2 is the square
of the total of the sums of all the individual values, and nt is the total number of measurements in the
time period of interest.

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This is a long term estimate of the central tendency observed for a control material based on a large a
number of control measurements collected over a long period of time. A long period here is at least
two months and could be several months, even a year. Changes in the accuracy of a method could
lead to shifts or drifts in the mean observed for a control material.

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 From the monthly statistics that are calculated, tabulate the monthly n's and xi's, which can then be
totaled for the period of interest (two months, several months), and used in the equation below to
provide the cumulative mean:

Where ( xi)t is the total of the monthly sums of individual values and nt is the total of the monthly ns
for the period of interest.

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The estimates for the cumulative or lot-to-date mean and standard deviation, as calculated above, are
used to calculate cumulative or lot-to-date control limits. Here's a table that illustrates the whole
procedure.
(Cumulative results are show in parentheses.)

Monthly total
Calculated
Month (cumulative Control Limits
statistics
total)
n x x2 Mean s Mean +/- 3s
1 20 3983 793465 199.15 3.63 188.3 - 210.0
2 20 3993 797537 199.65 4.20 187.1 - 212.2
(1591002
(40) (7976) (199.40) (3.86) (187.8 - 211.0)
(tel:1591002))
3 20 4002 801138 200.10 4.22 187.5 - 212.7
(60) (11978) (2392140) (199.63) (3.97) (187.7 - 211.6)
4 20 4020 808182 201.00 2.92 192.2 - 209.8
(80) (15998) (3200322) (199.96) (3.77) (188.7 - 211.3)
5 20 3995 798259 199.75 3.68 188.7 - 210.8
(100) (19993) (3998581) (199.93) (3.73) (188.7 - 211.1)

See a web-based QC calculator that performs these calculations.

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 A z-score is a calculated value that tells how many standard deviations a control result is from the
mean value expected for that material. It is calculated by taking the difference between the control
result and the expected mean, then dividing by the standard deviation observed for that control
material. For example, if a control result of 112 is observed on a control material having a mean of
100 and a standard deviation of 5, the z-score is 2.4 [(112- 100)/5]. A z-score of 2.4 means that the
observed control value is 2.4 standard deviations from its expected mean, therefore this result
exceeds a 2s control limit but not a 3s control limit.

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It is very helpful to have z-scores when you are looking at control results from two or more control
materials at the same time, or when looking at control results on different tests and different materials
on a multitest analyzer. You can quickly see if any result exceeds a single control limit, for example, a
z-score of 3.2 indicates that a 3s control limit has been exceeded. You can also look for systematic
changes or trends occurring across different control materials, for example, consecutive z-scores of 2
or greater on two different control materials.

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If you participate in an external quality assessment program or a proficiency testing program, you are
asked to analyze a series of unknown specimens and submit your test results for comparison with
those obtained by other laboratories. The data from all the laboratories are usually analyzed to
determine an overall average and standard deviation for the group. The program will generally report
your performance relative to the group. The difference between your test results and the overall
average is often expressed by a standard deviation index, or SDI, which expresses the difference in
terms of the number of standard deviations from the overall mean. For example, an SDI of 1.0 would
indicate your result fell one standard deviation from the mean. On a series of specimens, if you
observe SDIs such as +1.5, +0.8, +2.0, +1.4, and +1.0 (all positive), this suggests that your method is
generally running on the high side and is biased, on average, by +1.3 SDI. To figure the size of this
average bias in concentration units, you need to multiply by the actual value of the group SD.

Note the similarity between the calculation of the SDI and the z-score. They're basically the same
thing, but the z-score tends to be used in internal QC programs to compare an individual QC result
with the expected values for that material, whereas the SDI tends to be used in external QC programs
to compare the performance of the lab with the overall mean for a defined comparative group or with
an established target value.

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:
 One advantage is that it allows you to inspect results from many different tests at the same time,
without having to think about different units and the actual magnitude of the change in the units of the
test. In general, any SDI of 2.0 or greater deserves some special concern, regardless what the test is.
Any test whose average SDI is 1.0 or greater deserves some special attention because your method
shows a systematic difference from the group. In the future, this bias might lead to unacceptable
results.

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