Tools, Technologies and Training for Healthcare Laboratories

Basic Method Validation, 4th Edition, extras


Basic Method Validation, 4th Edition

Basic Method Validation
Fourth Edition

2020, 320 pages

ISBN13: 978-1886958-258

James O. Westgard, Ph.D.
with contributions from:

Nils Person, PhD
Elsa F. Quam, BS MT(ASCP)
Patricia L. Barry, BS MT(ASCP)
Sharon S. Ehrmeyer, Ph.D.
R. Neill Carey, Ph.D.

Basic Method Validation,

For all the extras that couldn't fit into the fourth edition,

This is the home page for those who have purchased a copy of the Basic Method Validation manual, third edition. For owners of the book, this page provides links to supplementary material not available to the general public. (You will need to provide proof of purchase in order to gain access to these resources)

Method Validation Enhanced Online Tool Kit

You will need to contact This email address is being protected from spambots. You need JavaScript enabled to view it. to gain one free period of access to these tools. You will be asked to provide some type of proof of purchase (order #, PO#, date of purchase, etc.) Please allow 1-3 business days for reply.


Basic Method Validation is part of a trilogy of “back to basics” books that focus on analytical quality management. The other two books are Basic QC Practices and Basic Planning for Quality. When I teach these materials, I start with method validation because it introduces the basic concepts of analytical performance and the experimental and statistical techniques needed to describe performance in quantitative terms. These concepts carry through into the practice of QC and the selection of optimal QC procedures via quality design and planning.

The original source of this approach to method validation goes back thirty years to a series of papers that were published in the American Journal of Medical Technology and later as a monograph titled Method Evaluation. My co-authors were Diane J de Vos, Marian R. Hunt, Else F. Quam, R. Neill Carey, and Carl C. Garber, all of whom worked at the University of Wisconsin. We introduced this approach at workshops that were taught at the national ASMT and AACC meetings. Today Neill and Carl, together with David Koch, continue to teach this approach at the AACC national meeting. They now hold the record for the longest running workshop in AACC history.

For more than fifty years, I have worked on quality control and method validation. While statistics, equations and calculations may not change, the context and the environment are constantly evolving. I hope this latest edition helps you understand these method validation numbers in the proper context of your laboratory.

James O. Westgard
Madison Wisconsin

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