Tools, Technologies and Training for Healthcare Laboratories


Basic Method Validation, 3rd Edition, extras


Basic Method Validation, Third Edition

Basic Method Validation
Third Edition

2008, 320 pages

ISBN13: 978-1886958-258

James O. Westgard, Ph.D.
with contributions from:
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,
Third Edition EXTRAS

For all the extras that couldn't fit into the third 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. (In some cases, you will need to provide proof of purchase in order to gain access to these resources)

Frequently-Asked-Questions about Method Validation

Glossary of Terms

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.

Use and Interpretation of Common Statistical Tests in Method Comparison Studies (Original Clin Chem paper, PDF)

A Method Evaluation Decision Chart (MEDx Chart) for Judging Method Performance (Original Clin Chem paper, PDF)

Method Validation Worksheets (PDF)

Normalized OPSpecs Charts and worksheets

Normalized OPSpecs Calculator


Foreword to the Third Edition

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.

This third edition provides important updates based on new regulatory requirements and emerging standards of practice, particularly the latest guidelines from CLSI (Clinical and Laboratory Standards Institute):

• Updated CLIA regulations and accreditation requirements;

• Revised chapter on reportable range that includes calibration verification;

• Revised chapter on detection limits that includes concepts of Limit of Blank, Limit of Detection, and Limit of Quantitation, as recommended in the CLSI EP17 guideline;

• Updated “Method Decision Chart” that includes criteria for 2, 3, 4, 5, and 6-Sigma performance;

• New chapter on estimation of trueness and precision based on the CLSI EP15-A2 guideline, including directions for performing the required calculations using electronic spreadsheets;

• New chapter on evolving global standards (ISO, International Organization for Standardization), ISO 15189, and the concepts of trueness and measurement uncertainty.

• New chapter on Six Sigma metrics, including instructions on how to convert method validation data into Sigma metrics.

For more than thirty 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 third edition helps you understand these method validation numbers in the proper context of your laboratory.

James O. Westgard
Madison Wisconsin

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