Method Validation Basics Course Information

Method Validation Basics focuses on the essentials for validating the performance of moderately or highly complex laboratory methods. These classes of methods comprise the largest number of methods in use in healthcare laboratories, therefore, the knowledge and skills involved with basic method validation represent the minimum training and education needed in any healthcare laboratory.

Dr. James O. Westgard 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 Quality Management, Clinical Laboratory Science Program, Director of Quality Management Services in the Clinical Laboratories at the University of Wisconsin Hospital & Clinics, and Principle 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, PhD, 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 must always be validated are the reportable range and the reference intervals for patient test results. Proper management of any testing process requires that these characteristics be measured experimentally to determine whether the observed performance is acceptable for the intended clinical applications.

Students will develop the expertise to:

• Define the quality required for a laboratory test;
• Select, organize, and plan the experiments to be performed;
• Collect appropriate experimental data;
• Analyze experimental data with appropriate statistics;
• Estimate the size of the analytic errors observed for the method;
• Judge the acceptability of a method for its intended medical application.

All the materials for this course are available via the Internet.

• The syllabus lists the different units (lessons, practical exam, online exam) and provides links to individual lesson plans. BOOKMARK THE SYLLABUS AS THE STARTING PAGE FOR YOUR DAILY STUDIES.
• Each lesson plan provides a list of specific objectives, links to course materials for that lesson, a list of things to do, and some questions for self-assessment. Selected reference papers are provided in PDF format and can be read (and printed) using the Adobe Acrobat Reader.

The course consists of 15 study units, including 13 lessons, 1 practical exam, and 1 on-line exam.

Lesson 1. Is quality still an issue for laboratory tests? In this introductory lesson, Dr. Westgard challenges current thinking that xxxxytical 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 provide a framework for managing quality in a laboratory.

Lesson 3. What quality is needed for laboratory tests? The need for "standards of quality" is discussed by Jerry Ehrmeyer, then Dr. Westgard describes the different kinds of standards of quality that are used for laboratory tests, with particular emphasis on the implication of the CLIA proficiency testing criteria for acceptable performance.

Lesson 4. What are the regulatory requirements for the validation of laboratory methods? The CLIA system of classifying laboratory methods according to complexity is described, along with the different method validation requirements for tests of different complexity.

Lesson 5. 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 6. How do you select a new method? The different types of method characteristics that need to be considered are described, as well as which characteristics are of primarily importance in method selection and which are the focus of the method validation experiments.

Lesson 7. What are the experiments that validate method performance? Individual experiments are identified and related to the type of error that can be estimated, then these experiments are organized into an efficient plan.

Lesson 8. How do you statistically xxxxyze the experimental data? General guidelines are provided for the statistics that are used for individual experiments. A "data xxxxysis toolkit" is introduced and online calculators are demonstrated.

Lesson 9. How do you determine the reportable range of a method? The details for carrying out a "linearity experiment" are described, including how the data is xxxxyzed to assess the "reportable range" of an xxxxytical method.

Lesson 10. How do you determine the imprecision of a method? The replication experiment is described, along with the calculation of the mean, SD, and CV.

Lesson 11. How do you determine the accuracy of a method? The comparison of methods experiment is described and the importance graphing the data is emphasized. Appropriate statistical calculation may include t-test statistics (mean, SDdiff, t-value) or linear regression statistics (slope, y-intercept, standard deviation about the regression line, correlation coefficient).

Lesson 12. How do you verify reference range? The problem of verifying a reference range is distinguished from the problem of estimating reference intervals to provide a practical experiment that requires minimum data.

Lesson 13. How do you judge the acceptability of a method? Given the data collected in the basic experiments, the observed performance can be judged using a graphical tool – the Method Decision Chart.

Unit 14 – Practical Exam. Can you assess the acceptability of a new method? This is an open book exam in which example data or an example method validation report must be critically assessed to judge the acceptability of a method.

Unit 15 – On-line Exam. Open book exam with two hour time limit.