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Levey-Jennings Control Chart Explained

The document discusses the Levey-Jennings control chart, a graphical method for displaying control results over time, and outlines various concepts related to analytical competence, quality control, and measurement errors. It defines key terms such as analytical run, accuracy, precision, and the Westgard rules used for quality control. Additionally, it emphasizes the importance of maintaining analytical quality through established limits and reference materials.

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5 views27 pages

Levey-Jennings Control Chart Explained

The document discusses the Levey-Jennings control chart, a graphical method for displaying control results over time, and outlines various concepts related to analytical competence, quality control, and measurement errors. It defines key terms such as analytical run, accuracy, precision, and the Westgard rules used for quality control. Additionally, it emphasizes the importance of maintaining analytical quality through established limits and reference materials.

Translated by

ScribdTranslations
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Levey-Jennings control chart

Graphical method that shows the results of the


controls. The results are graphed
sequentially in time (X axis), and the result
of the measurement (Y axis).
Westgard rules or multi-rules for
accept or reject an analytical run
ISP CHILE INFORMATION
Analytical competence: expertise, aptitude, suitability or
the ability that an analytical method has to achieve
meet the quality requirements, which are
defined as optimal by the clinical laboratory for
a certain analyte, usually defined at
through the maximum allowed Total Error, in such a way,
that the TotalError obtained for an analyte
determined in the laboratory is less than the Error
Maximum allowed total (ETa) or its components by
separated.
Quality control: Area of quality management
focused on meeting the requirements of
quality.

Analytical run: Interval (period of time or a


series of measures) for which it is expected that the
the precision and accuracy of the measurement system are
established.
Analytical performance: laboratory capability
clinical to evaluate the quality control process
considering maximum imprecision and inaccuracy
["permitted","analytical range","interferences","recovery"]
and also the frequency and duration of the analytical error.
Measurement error: it is the difference between the result of
a measurement and the true value of the measured.
Random error: difference between a concrete result
of a measure and the average result that could
to be observed with an infinite number of measurements of the
same measurements carried out under conditions of
repeatability.

Systematic error: the average value that could result


from an infinite number of measurements of the same
measured carried out under conditions of
repeatability, less the true value of
measuring.
Critical Systematic Error: corresponds to the size of the
systematic error medically important that is
it is necessary to detect through the quality procedure,
to meet and maintain a quality requirement
defined.
ErrorTotal: Efecto combinado o neto del error
random and systematic.

Maximum allowed total error (ETa): requirement of


analytical quality that establishes a limit for the
imprecision (random error) and inaccuracy (error
systematic) and that are allowed in only one
measurement or in the result of a single exam.
Accuracy: degree of agreement between the result of
a measurement and a true value of the measured item; the
The concept encompasses veracity and accuracy, it applies to a
result.
Inaccuracy: degree of dispersion of the results
independent of the measurements obtained under
specific conditions. The statistical parameters
what defines them is the standard deviation or
coefficient of variation.

Uncertainty: parameter associated with the results of


a measurement that characterizes the dispersion of the
values that could be reasonably attributed to the
measuring.
Control chart limits: graphical criteria that allows
evaluate whether a measurement procedure is
finds inside or out of control. They are calculated
generally from the average and the standard deviation
standard that is determined by virtue of a
stable operation.
Measurement: a set of operations aimed at
purpose of determining a value of a magnitude.

Control material: substance that has one or more


of its established properties to allow its use
in a quantitative analytical series that allows knowing
the imprecision of the measurements.
Reference material: material or substance
prepared by a National or International Organization
recognized, in which one or several values of the(s)
property(ies) is (are) sufficiently homogeneous
and well defined(s) to allow its use for calibration of a
device, evaluate an analytical method or assign values
to materials.
Precision: degree of agreement between results
obtained from repetitions of the same sample and under
stipulated conditions.

Westgard Rules: Series of control rules


used in the quality control procedure for
analyze the measurement of control.
Repeatability: precision of the results of a
measurements obtained with the same method, the same
operator, the same measuring instrument and during
a defined time.

Reproducibility: accuracy of the results of a


measurements obtained with the same method, on the
same measured but under different conditions
(different operators, batch of reagents, equipment of
measurement, laboratories, etc.).
Traceability: property of a measurement or value of
a pattern that must be related to references
established, generally national patterns or
international, through a chain
uninterrupted comparisons, all of them with
established uncertainties.

Bias: it is the difference between the results


expected and the accepted reference values.
Veracity: degree of agreement between the average
from the results of infinite measurements and a value of
reference.

Verification: confirmation through examination and


obtaining objective evidence that has been
the specified requirements are met.
BIBLIOGRAPHY

Techniques and Methods of Clinical Laboratory, 3rd Edition


José Manuel González de Buitrago, 2010.

Principles of Clinical Biochemistry and Molecular Biology, Álvaro


González Hernández, 2010.

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