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Quality Control Pathologists Shewhart's Individuals Control Chart

Quality control procedures like intralaboratory QC and interlaboratory proficiency testing are important to monitor the accuracy and precision of analytical test methods. Intralaboratory QC involves analyzing control samples daily to ensure test reliability, while interlaboratory proficiency testing periodically provides unknown samples to compare lab performance. Quality control charts like Levey-Jennings plots are used to visually monitor test performance over time and identify any issues.

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Pau Soriano
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31 views

Quality Control Pathologists Shewhart's Individuals Control Chart

Quality control procedures like intralaboratory QC and interlaboratory proficiency testing are important to monitor the accuracy and precision of analytical test methods. Intralaboratory QC involves analyzing control samples daily to ensure test reliability, while interlaboratory proficiency testing periodically provides unknown samples to compare lab performance. Quality control charts like Levey-Jennings plots are used to visually monitor test performance over time and identify any issues.

Uploaded by

Pau Soriano
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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1.

Define the ff:

Quality Control

- Laboratory quality control is designed to detect, reduce, and correct deficiencies in a


laboratory's internal analytical process prior to the release of patient results, in order to
improve the quality of the results reported by the laboratory.

Intralab QC

- QC testing is performed within a laboratory to monitor and ensure the reliability


of test results produced by the laboratory. Control materials (usually liquid
controls) are used to monitor the test system and verify that quality patient test
results have been attained. A control is a stabilized sample with a predetermined
range of result values that simulates a patient sample.
- Control samples are tested in the same way as patient samples. If the results from
testing a control sample are not within the acceptable ranges, we assume there
has been a problem in the test procedure, equipment, or the samples themselves.
There are many criteria for rejecting a test based on the control samples
measurements; these criteria will be detailed further in a later section. Patient
results are not reported until the cause of the problem has been found, the
problem resolved, and the controls retested to verify that everything is working
normally.
- It involves the analyses of control samples together with the patient specimens.
- It is important for the daily monitoring of accuracy and precision of analytical methods.
It allows identification of analytic errors within a one-week cycle.

Interlab QC

- It involves the proficiency testing programs that periodically provide samples of unknown
concentrations to participating clinical laboratories.
- It is important in maintaining long-term accuracy of the clinical methods
- It is also used to determine state-of-the art interlaboratory performance.

Levey-Jennings Chart

- A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual


indication whether a laboratory test is working well. The distance from the mean is measured
in standard deviations. It is named after Stanley Levey and E. R. Jennings, pathologists who
suggested in 1950 that Shewhart's individuals control chart could be used in the clinical
laboratory.[3] The date and time, or more often the number of the control run, is plotted on the
x-axis. A mark is made indicating how far the actual result was from the mean, which is the
expected value for the control. Lines run across the graph at the mean, as well as one, two
and three standard deviations to either side of the mean. This makes it easy to see how far
off the result was.

QC procedure(s) to be implemented

Each of the two control materials will be analyzed once per run, providing a total of two control
measurements per run. Control status will be judged by either the 1 2s or 13s rule. These rules are
defined as follows:

 12s refers to the control rule that is commonly used with a Levey-Jennings chart when the
control limits are set as the mean plus/minus 2s. In many laboratories, this rule is used to reject a
run when a single control measurement exceeds a 2s control limit.
 13s corresponds to a Levey-Jennings chart having control limits set as the mean plus/minus
3s. An analytical run is rejected when a single control measurement exceeds a 3s control limit.

The 12s rule is very commonly used today, and while it provides high error detection, the use of 2s
control limits gives an expected high level of false rejections. The 1 3s rule provides an alternative QC
procedure that has lower false rejections, but also lower error detection. In this exercise, you will see
how to apply both QC procedures and also get a feel for the difference in their performance.

Calculation of control limits

Two sets of control limits will be needed to implement the rules described above. The first set uses
2s control limits (for implementation of the 12s rule) calculated as the mean plus or minus 2 times the
standard deviation. The second set uses 3s control limits (for implementation of the 1 3s rule)
calculated as the mean plus or minus 3 times the standard deviation.

For this example, Control 1 has a mean of 200 and a standard deviation of 4 mg/dL.
The upper control limit would be:
200 + 2*4, which is 208 mg/dL.
The lower control limit would be:
200 - 2*4, or 192 mg/dL.

Cumulative Sum Graph

- A cumulative sum (CUSUM) chart is a type of control chart used to monitor small
shifts in the process mean. It uses the cumulative sum of deviations from a target.

- The CUSUM chart plots the cumulative sum of deviations from the target for
individual measurements or subgroup means.

The CUSUM requires two parameters:


 A reference value (k) specified in sigma units. k is often set to half the shift to be
detected, in sigma units. Default k=0.5 which is equal to detecting a shift of 1 sigma.

 The decision limit (h) specified in sigma units. Default h=5.

When designing a CUSUM chart it is necessary to consider the average run length and shift
to be detected. Extensive guidance is available on suitable parameters (NIST 2012,
Montgomery 2012).

It is possible to modify the CUSUM, so it responds more quickly to detect a process that is
out-of-control at start-up. This modification is done using an initial CUSUM equal to half of
the h parameter.

Like the EWMA, CUSUM is sensitive to small shifts in the process mean but does not match
the ability of a Shewhart chart to detect larger shifts. For this reason, it is sometimes used
together with a Shewhart chart (Montgomery 2012).
-

Youden Twin Plot

- The CUSUM requires two parameters:


- A reference value (k) specified in sigma units. k is often set to half the shift to be detected,
in sigma units. Default k=0.5 which is equal to detecting a shift of 1 sigma.
- The decision limit (h) specified in sigma units. Default h=5.
- When designing a CUSUM chart it is necessary to consider the average run length and
shift to be detected. Extensive guidance is available on suitable parameters (NIST 2012,
Montgomery 2012).
- It is possible to modify the CUSUM, so it responds more quickly to detect a process that is
out-of-control at start-up. This modification is done using an initial CUSUM equal to half of
the h parameter.
- Like the EWMA, CUSUM is sensitive to small shifts in the process mean but does not
match the ability of a Shewhart chart to detect larger shifts. For this reason, it is
sometimes used together with a Shewhart chart (Montgomery 2012).

Trend Shift

- Trend shift signals a change in the website performance. It provides a starting point


to analyze the change (increase/decrease) in the metric being monitored. Performance
analysts can use this data to identify the root cause and take corrective measures if
necessary.

Specificity

- The specificity of a test is its ability to designate an individual who does not have a
disease as negative.
- "Analytical specificity" refers to the ability of an assay to measure on particular
organism or substance, rather than others, in a sample.

Sensitivity

- Sensitivity refers to a test's ability to designate an individual with disease as positive. A


highly sensitive test means that there are few false negative results, and thus fewer
cases of disease are missed.
- "Analytical sensitivity" represents the smallest amount of substance in a sample that can
accurately be measured by an assay. 

Accuracy

- Accuracy is a measure of how close a measurement is to the correct or accepted value


of the quantity being measured

Precision

- Precision is a measure of how close a series of measurements are to one another.

Random Error

- Random errors occur because of random and inherently unpredictable events in the
measurement process.

Systematic Error

- -Systematic errors occur when there is a problem in the measurement system that
affects all measurements in the same way.

2. What is the importance of quality control?

- Quality control is essential to building a successful business that delivers products


that meet or exceed customers' expectations. It also forms the basis of an efficient
business that minimizes waste and operates at high levels of productivity.

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