Course Description
Course Description
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Course Description |
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Basic Method Validation focuses on the essentials for validating the performance of laboratory methods for moderate or high complexity tests. These methods comprise the majority of tests performed in most healthcare laboratories. The knowledge and skills required for basic method validation are the minimum training and education needed to validate method performance in any healthcare laboratory. This online course has been accredited by the ASCLS for 15 PACE credits and by the AACC for 15 ACCENT credits. |
James O. Westgard, Ph.D., is the primary instructor and is responsible for the contents of this course. Dr. Westgard is a Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School, Co-Director of the Graduate Certificate in Laboratory Quality Management in the Clinical Laboratory Science Program, Director of Quality Management Services in the Clinical Laboratories at the University of Wisconsin Hospital &Clinics, and Principal in Westgard Quality Corporation.
Other Clinical Laboratory Scientists who provide parts of the instruction include Patricia L. Barry, B.S., MT(ASCP) and Elsa F. Quam, B.S., MT(ASCP), who are Quality Specialists in the Clinical Laboratories at the University of Wisconsin Hospital & Clinics, and Sharon S. Ehrmeyer, Ph.D., MT(ASCP), who is CLS Program Director, Co-Director of the Graduate Certificate Program, and Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School.
Precision and accuracy are fundamental performance characteristics of an analytical method and must be properly managed to assure the quality of any laboratory test. Related characteristics that are always important are the reportable range and the reference intervals for patient test results. Proper management of any testing process requires that these characteristics be validated to assure that laboratory performance is acceptable for the intended clinical applications.
Students will develop the skills and expertise to:
All the materials for this course are available via the Internet.
Basic Method Validation is approved at the Intermediate Level of Instruction for 15 hours of PACE credit. Participants may register with the ASCLS and pass a final exam to receive the 15 PACE credits. The internet materials are being provided on this, the website of Westgard QC. Participants who wish to receive ACCENT credits must register directly through the Westgard Web.
The course consists of 15 lessons, 1 practice exam, and 1 online exam.
Lesson 1. Is quality still an issue for laboratory
tests?
In this introductory lesson, Dr. Westgard challenges current thinking
that analytical quality is better than needed for medical care.
Lesson 2. How do you manage quality?
The principles of Total Quality Management (TQM) are adapted to
define a framework for managing quality in a healthcare laboratory.
Lesson 3. What is the purpose of a method validation
study?
In this lesson, Dr. Westgard reveals the inner, hidden, deeper,
secret method of method validation. Knowing the secret is the
key to developing a practical approach to method validation.
Lesson 4. What are the regulatory requirements for method
validation?
Dr. Sharon Ehrmeyer reviews the US government's CLIA guidelines
for method validation, as well as CAP and JCAHO accreditation
requirements.
Lesson 5. How is a method selected?
This lesson describes the different types of method characteristics
and identifies those that must be addressed when selecting the
analytical method or system.
Lesson 6. What experiments are necessary to validate
method performance?
The types of analytical errors of interest are identified and
related to specific experiments that estimate the magnitude of
those errors. These experiments are then organized into a study
plan.
Lesson 7. How are the experimental data analyzed?
This lesson provides an overview of the data analysis "tools"
that should be used with the different experiments. A "data
analysis toolkit" is introduced and available calculation
resources are discussed.
Lesson 8. How is the reportable range of a method determined?
In this lesson, Elsa Quam describes how a "linearity or reportable
range" experiment is carried out. She provides a practical
procedure for preparing mixtures of two pools and includes detailed
worksheets.
Lesson 9. How is the imprecision of a method determined?
The "replication" experiment is described, the important
experimental factors are identified, and the appropriate data
calculations are discussed.
Lesson 10. How is the inaccuracy or bias of a method
determined?
This lesson describes how a "comparison of methods"
experiment is carried out and how the data should be analyzed,
emphasizing both statistical calculations and graphical displays.
Regression and t-test statistics are considered, along with comparison
and difference plots.
Lesson 11. What other experiments might be needed to validate method performance? Experiments for "interference," "recovery," and "detection limit" are described. These experiments are sometimes needed with immunoassay tests and therapeutic drug monitoring tests, and also are generally required when a laboratory modifies a manufacturer's method.
Lesson 12. How do you judge the performance of a method?
Given the data collected in the method validation experiments,
the experimental results can be interpreted using a graphical
technique - the Method Decision Chart. This lesson describes how
to construct a Method Decision Chart and use it to judge the performance
of a method.
Lesson 13. How is a reference interval verified?
In this lesson, Patricia Barry presents a practical procedure
for assessing the validity of a manufacturer's recommendations
for reference intervals.
Lesson 14. What's a practical procedure for validating
a method?
This lesson reviews the overall approach to method validation
and provides a set of worksheets for collecting the minimum amount
of data needed in each experiment. With this background and these
worksheets, you can plan and organize your own study.
Lesson15. What questions do you have about method validation?
Answers to frequently asked questions are provided to clarify
some of the sticky points in method validation. A summary of "points
of care" for applying statistics is also provided.
