"Some will find this book too controversial and frustrating to read." - D. Joe Boone, CDC
Read the Clinical Chemistry Review of this book

Nothing but the Truth about Quality 

Nothing but the Truth about Quality,
Essays on Quality Management in the Healthcare Laboratory
 
2004, 258 pages
$60 list price
 

Author: 
James O. Westgard, Ph.D., FACB  

Contents: 

  • 25 Chapters 
  • 5 commentaries on Truth, QC, Goals, Standards, and Managment 
  • Foreword by Callum Fraser, noted expert on Biologic Variation
  • Preface and Suggestions on use of the book
  • Appendix on the use of OPSpecs Charts as essential QC tools

Nothing but the Truth about Quality

Essays on Quality Management in the Healthcare Laboratory

  • NEW, UPDATED and COLLECTED ESSAYS BY JAMES O. WESTGARD, PHD, FACB
  • WITH AN INTRODUCTION BY CALLUM FRASER, NOTED EXPERT ON BIOLOGIC VARIATION

The Collected Wisdom and
Advice of an International Expert on laboratory quality management

With the help of Dilbert cartoons, Dr. James O. Westgard, PhD, outspoken advocate for better quality in healthcare laboratories and creator of the "Westgard Rules", presents a collection of essential writings on quality. These essays, many of them originally published on Westgard Web, cover topics ranging from Six Sigma to Diabetes, Cholesterol to hs-CRP, Enron to Firestone, NCEP to the CLIA Final Rule, ISO uncertainty to Evidence-Based Medicine. Together, they provide you with a broad and in-depth analysis and perspective on current quality management practices and the need for improvements.

A No-Holds Barred Look at the State of Quality in Healthcare Laboratories

Taken together, these essays fire a broadside at the conventional wisdom about the state of quality in laboratory testing today. This is a book that must be read by laboratory directors and manager, industry executives and consultants, government regulators and surveyors, and professional accreditors and inspectors.

Learn the dirty little secrets about the lack of quality in laboratory testing today...

  • Why scientific studies may be biased by unscientific assumptions about the performance and stability of laboratory testing processes.
  • How professional standards and practice guidelines are setting the wrong goals for quality - and don't know it
  • Why "Electronic QC" and "Equivalent QC" endanger the quality of patient testing
  • How CLIA has failed to assure the quality of laboratory testing
  • Why current management practices may be bad for healthcare organizations
  • And much much more...

Nothing but the Truth about Quality is the real book on quality management in the healthcare laboratory. Bringing these issues to life and into your life - it goes beyond the formal scientific papers and the glossy instrument brochures to illustrate the importance of quality in everday issues, especially healthcare.

Finally, you can get the truth about quality.

View the Table of Contents!

Download the Foreword, Preface, TOC, and First Commentary!

Order the manual now! 


Table of Contents
The Truth, the Whole Truth, and Nothing but the Truth 1
1. A Truth Standard for Quality 3
2. Quintiles and Quality 11
3. Why not Evidence-Based Method Specifications? 19
4. Cooking the Books: Is it happening in lab error budgets? 29
5. Think Straight, Talk Straight 37
Nothing but the Truth about Quality Goals 43
6. Quality Goals, Requirements and Specifications 45
7. Quality by Design 61
8. Quality Goals and Equivalent Quality Testing 69
9. Errors in Reasoning about Laboratory Errors 77
10. JCAHO Patient Safety Goals 85
Nothing but the Truth about Quality Control 93
11. Good Data Wanted, Bad Data Need Not Apply! 95
12. Autoverification: Taking QC to the Next Level - up or down? 103
13. "Electronic QC" and the Total Testing Process 111
14. Lies, Damn Lies, and "Equivalent QC" 121
15. Doing the Right QC 127
Nothing but the Truth about Quality Standards and Regulations 143
16. Enron and Quality - When Opposites Detract 145
17. CLIA Postponed and postponed and postponed and postponed 155
18. ISO Says So: Recommendations for Validation of User QC 163
19. To be Uncertain or in Error? That is the Question 171
20. Quality-Less Compliance 177
Nothing bu the Truth about Quality Management 185
21. Quality in the New Millenium 187
22. Quality is Job 1 when the Rubber meets the Road 197
23. It's not Rocket Science: Lessons from the Shuttle Disasters 205
24. Medical Errors - Complexity and its Solutions 215
25. Truth, just Truth 223
Appendix 1: Primer on OPSpecs Charts 233
Postscript: It's an Honor 249
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The 2005 Clinical Chemistry Review

Reviewed by D. Joe Boone
Division of Laboratory Systems
Office of Public Health Partnerships
National Center for Health Marketing
CDC, Atlanta, GA

This book is a collection of 25 essays taken from those published by the guru of quality control on www.westgard.com over the last few years. These essays are intended to stimulate the reader to reexamine current quality control, quality management, and planning processes to determine whether these processes, in fact, evoke the "truth about the quality of laboratory testing". The book is divided into five parts exploring quality as truth, quality goals, quality control, quality standards/regulations, and quality management, with an added appendix containing a Primer on OPSpecs Charts. The author strives to make the subject both lively and controversial. Certainly the book will be viewed by many as controversial because it takes issue with actions of professional organizations and their members, government agencies, the diagnostics industry, healthcare organizations, accrediting and standard setting bodies, businesses, and about everyone in between for the current state of quality in laboratory testing.

Reasons are given for including each chapter in the book, which should help those trying to use it as a quick reference or for training clinical laboratory scientists and clinical pathology residents. A major concern about this book is that it mixes science and social values in developing a case for what the author views as an inherent inattention to and inadequacy of quality in healthcare. This is illustrated with the use of high-sensitivity C-reactive protein test, the American Diabetes Association/US Department of Health and Human Services (ADA/HHS) guidelines for diabetes diagnosis and treatment monitoring, and National Cholesterol Education Program (NCEP) guidelines. In each case, the author paints a picture of inconsistency between the science and the policy goals, especially if the desire is to have greater than four sigma laboratory test performance.

As one might expect, the strength of this book is the science behind the quality control recommendations. However, by including other topics such as the Enron and Arthur Andersen scandals, and by implying that our healthcare system and laboratories are now compliance mills rather than quality driven, the author presents a view of the world that some may consider biased and cynical. In so doing, he misses an opportunity to promote the value of implementing quality systems thinking in healthcare, regardless of where laboratory testing is being performed - which is now almost everywhere. Whether the goal is compliance or quality or both, laboratorians could use insights and additional guidance about feasible approaches to quality (beyond statistical control) in our evolving healthcare system.

Near the end of the book the author adds a cautionary note indicating that those who find fault with mixing politics with laboratory science probably should stop reading. Some will find this book too controversial and frustrating to read. However, those who can bypass the strong opinions of the author will being to see quality as more than just a value that is difficult to define, but as a measure of truth. Is the book really "nothing but the truth?" You will be the judge.


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