if a downward trend is noted on a levey-jennings qc chart, what is the best course of action

by Tianna Botsford 10 min read

What does 1 3s mean on a Levey Jennings chart?

Sep 21, 2021 · In Basic QC Practices, 7 James Westgard introduces “Westgard Rules,” which are a variation on the Nelson rules for Levey Jennings charts used in laboratories. Levey Jennings charts use standard deviation instead of sigma estimator to calculate limits. His 7T rule (figure 3) adds one additional point to the trends in figure 1.

What is a trend in QC values?

QC Levey-Jennings charts are used to track the ... Charts are created for each test, and for each QC value within the test A control chart gives you a visual display of method stability or instability over a ... alternating up and down. If this trend is present, it

What are the limitations of Levy-Jennings charts?

a Levey-Jennings control chart. In the 1950's, Levey and Jennings applied statistical principles for analyzing QC in clinical laboratories. These principles (along with some modifications) are used in today's modern laboratories.

What are the Levey-Jennings control rules?

See QC - The Levey Jennings chart for more information about preparing control charts. In manual applications, a 1 2s rule should be used as a warning to trigger application of the other rules, thus anytime a single measurement exceeds a 2s control limit, you respond by inspecting the control data using the other rules.

What is a trend and shift on a Levey-Jennings chart?

A shift is a sudden change of values from one level of the control chart to another. A common cause of a shift is failure to recalibrate when changing lot numbers of reagents during an analytical run. A trend is a continuous movement of values in one direction over six or more analytical runs.

What does a Levey-Jennings chart show?

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.

How do you read a quality control chart?

The following rules can be used to properly interpret control charts:Rule 1 – One point beyond the 3 σ control limit.Rule 2 – Eight or more points on one side of the centerline without crossing.Rule 3 – Four out of five points in zone B or beyond.Rule 4 – Six points or more in a row steadily increasing or decreasing.More items...•Feb 15, 2021

What are the control limits of the Levey-Jennings chart?

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.

How is Levey-Jennings calculated?

The Levey-Jennings chart uses the calculated standard deviation (or a known standard deviation) to determine the control limits. The individuals control chart uses an estimated standard deviation from the range chart to determine the control limits.

What is trend and shift?

Applicable to run charts and control charts, a shift in its most basic form is seven points in a row either above or below the centerline. A trend is seven points in a row in an upward direction or seven points in a row in a downward direction.Jan 4, 2013

How do you make a Levey Jennings chart?

Here are the steps to create a Levey Jennings Chart using QI Macros:Click and drag over your data to select it.Next, click on the QI Macros menu > Control Charts (SPC) > Special (CUSUM, EWMA) and then on the type of Levey Jennings Chart you want.More items...

What does control chart tell you?

The control chart is a graph used to study how a process changes over time. Data are plotted in time order. A control chart always has a central line for the average, an upper line for the upper control limit, and a lower line for the lower control limit. These lines are determined from historical data.

How do you know if a control chart is in control?

Control charts are used to determine whether a process is in statistical control or not. If there are no points beyond the control limits, no trends up, down, above, or below the centerline, and no patterns, the process is said to be in statistical control.

How many Westgard rules are there?

The well-known Westgard multirule QC procedure uses 5 different control rules to judge the acceptability of an analytical run.

What is r4s rule?

Westgard Rule R. 4s The R4s rule applies to controls within a run. If two controls exceed 4SD, that is, if one control exceeds +2SD and the other control (or another control, if more than 2 controls are tested) exceeds -2SD, the run should be rejected.

What are the Westgard rules and how should they be used to assess quality control results?

Westgard Rules are multirule QC rules to help analyze whether or not an analytical run is in-control or out-of-control. It uses a combination of decision criteria, usually 5 different control rules to judge the acceptability of an analytical run.Apr 1, 2020

What is a multirule QC procedure?

First, a non-technical description. When my daughter Kristin was young and living at home, she liked to party. One day when she told me she was again intending to be out late, I felt the need to exert some parental control over her hours.

What are the "Westgard rules"?

For convenience, we adopt a short hand notation to abbreviate different decision criteria or control rules, e.g., 1 2s to indicate 1 control measurement exceeding 2s control limits. We prefer to use subscripts to indicate the control limits, but other texts and papers may use somewhat different notation (e.g.

What are other common multirules?

In situations where 3 different control materials are being analyzed, some other control rules fit better and are easier to apply, such as:

How do you perform multirule QC?

You collect your control measurements in the same way as you would for a regular Levey-Jennings control chart. You establish the means and standard deviations of the control materials in the same way.

What is N?

When N is 2, that can mean 2 measurements on one control material or 1 measurement on each of two different control materials. When N is 3, the application would generally involved 1 measurement on each of three different control materials.

Why use a multirule QC procedure?

Multirule QC procedures are obviously more complicated than single rule procedures, so that's a disadvantage. However, they often provide better performance than the commonly used 1 2s and 1 3s single-rule QC procedures.

Are there similiar strategies for QC testing and diagnostic testing?

Yes, a QC test is like a diagnostic test! The QC test attempts to identify problems with the normal operation of an analytical testing process, whereas the diagnostic test attempts to identify problems with the normal operation of a person. Appropriate action or treatment depends on correctly identifying the problem.

Example Application

  • For a cholesterol method, two different commercial control products have been selected that have concentrations near the important medical decision levels of 200 mg/dL and 240 mg/dL identified by the National Cholesterol Education Program (NCEP) guidelines for test interpretation. The materials were analyzed once per day for a period of twenty days. From thes…
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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 12s or 13srule. These rules are defined as follows: 1. 12srefers 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 i…
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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 13srule) calculated as the mean plus or minus 3 times the standard deviation. For this example, …
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Preparation of Control Charts

  • This exercise shows how to construct control charts manually using standard graph paper. For this exercise, graph paper having 10x10 or 20x20 lines per inch works well. You will need two sheets, one for each chart of the two control materials. While it is possible to prepare both charts on a single sheet, this may reduce the readability of the control charts. If you do not have graph …
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Use of Control Charts

  • Once the control charts have been set up, you start plotting the new control values that are being collected as part of your routine work. The idea is that, for a stable testing process, the new control measurements should show the same distribution as the past control measurements. That means it will be somewhat unusual to see a control value that exceeds a 2s control limit an…
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