For more than 30 years, Dr. James O. Westgard has been at the forefront of method validation and quality. After pioneering the method evaluation approach, he has consistently championed the proper techniques to validate and verify the performance of laboratory methods. With this third edition of Basic Method Validation, Dr. Westgard provides a crucial update on the tools and techniques of laboratory method assessments.

This third edition includes the following updates and additions:

• Revised chapter on regulations that reflects the Final CLIA Rule as well as the latest CAP and Joint Commission requirements.
• Revised chapter on reportable range that includes calibration verification.
• Revised chapter on detection limit that describes the concepts of Limit of Blank, Limit of Detection, and Limit of Quantitation.
• Revised Method Decision Chart that includes the Six Sigma goal for
  world class quality.
• New chapter on the estimation of trueness and precision based on the CLSI User Verification Performance for Precision and Trueness guideline, including directions for performing the required calculations.
• New chapter on evolving global standards (ISO) and the ISO 15189 standard, as well as the concepts of trueness and measurement uncertainty.
• New chapter that discusses how to translate method validation data into Sigma-metrics.
• Exclusive access to an online method validation toolkit that performs these validation calculations.

With the best of the previous editions and new material from the third edition, Basic Method Validation teaches you how to:

• Perform your method validation experiments quickly, efficiently, correctly!
• Choose the order of the experiments to save time!
• Collect the appropriate data for each experiment - without wasting specimens!
• Calculate the right statistics!
• Interpret the method validation results rationally!
• Judge the acceptability of the method, not the statistics!
• Establish a practical procedure for validating a method!

Basic Method Validation addresses healthcare professionals who perform laboratory tests in central laboratories, clinic or outpatient laboratories, and point-of-care settings. This concise, easy-to-read, 320-page manual contains a comprehensive introduction to method validation in the laboratory, from the conceptual idea of method validation to the bench-level specifics of planning an experiment:

• The inner, hidden, deeper, secret meaning behind method validation is revealed (i.e. why do we do what we do!).
• The requirements of CLIA, CAP, Joint Commission and other agencies are explained so you know what experiments your laboratory has to perform.
• All the experiments are explained in detail, from the number of specimens needed, how long the experiment should take, what problems to look out for, as well as (most importantly) what the numbers mean when you're finally done.
• Practical experimental plans and worksheets are provided so readers can immediately evaluate and improve their current method validation practices.

Publisher: Westgard Quality Corporation (TQC)

Author: James O. Westgard, PhD

Copyright: 2008

Pages: 320

Size: 6" x 9"