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Basic Method Validation, 4th Edition

 Westgard QC is proud to announce the new 4th edition of our popular textbook, Basic Method Validation and Verification.

Basic Method Validation and Verification, 4th Edition

Training in Statistical Quality Control for Medical Laboratories

BMVcover5002020, 312 pages, 9" by 6" paperback
ISBN1-886958-33-5
ISBN13: 978-1-886958-33-3
List price: $80.00

Download the Preface, Table of Contents, Index and Chapter Excerpts (more than 40 pages!) of this book.

[Special offer! Save $10 off the cost of the book with the coupon code GETVERIFIED.
The fine print: Online store only, cannot be combined with other offers. One coupon per order, per customer. Expires November 30th, 2024.]

BASIC METHOD VALIDATION AND VERIFICATION: REVISED, EXPANDED AND UPDATED!

  • THE BEST EXPLANATION OF HOW TO CHECK OUT A NEW METHOD IN YOUR LAB
  • OVER 100 CHARTS, GRAPHS, TABLES and ILLUSTRATIONS!
  • THE DEFINITIVE BOOK ON LABORATORY QUALITY FOR MORE THAN TWO DECADES
  • NOW INCLUDES A CHAPTER ON QUALITATIVE TEST VALIDATION AND VERIFICATION - CRUCIAL FOR PCR, SEROLOGY AND LATERAL FLOW TESTS USED IN THE COVID19 PANDEMIC
  • DISCUSSES THE STRENGTHS AND WEAKNESSES OF CHOOSING VALIDATION OR VERIFICATION FOR YOUR METHODS
  • EXPLAINS HOW ISO STANDARDS INTEGRATE WITH CLIA, CAP AND OTHER REGULATIONS

Thousands of medical technology professionals have made the Basic Method Validation and Verification their roadmap to implementing new methods in their laboratory.

In the fourth edition, Dr. James O. Westgard and colleagues have updated their coverage:

  • Updated Verification and Validation regulations, guidelines, and recommendations from around the world.
  • New explanations about practical approaches to validate Qualitative methods
  • Expanded discussion of the multiple ways to compare methods, from Difference plots to  Scatter plots, from Deming regression to Passing-Bablok
  • Exclusive access to online content that supplements and tests your knowledge of the material

Basic Validation and Verification is the plain language, common sense guide to the studies and statistics that govern the evaluation, validation and verification of a laboratory method. For healthcare pratictioners who want to implement and operate valid QC procedures, this manual is an essential reference.

Table of Contents

 

CHAPTER PAGE
1. Is Quality still an issue for laboratory tests? 1
2. How do you manage quality? 13
3. What is the purpose of a method validation study? 31
4. What are the regulatory requirements for basic method validation? 41
5. How is a method selected? 65
6. What experiments are necessary to validate or verify method performance? 75
7. How are the experimental data analyzed? 89
8. How is the reportable range of a method determined? 101
9. How is the imprecision of a method determined?
 117
10. How is the inaccuracy (bias) of a method determined? 133
11. What’s another way to determine accuracy?
 159
12. How do you test for more specific sources of inaccuracy? 171
13. What is the lowest test value that is reliable? 179
14. How is a reference interval verified? 189
15. How do you judge the performance of a method? 199
16. What’s a practical plan for validating/ verifying? 213
17. How do you validate a qualitative method? 233
18. How can claims be evaluated on the Sigma scale? 251
19. Self-Assessment Questions and Answers and Example Datasets 259
The Statistical Appendix
 289
Index

305