Assuring the Right Quality Right

2007, 288 pages, 6 x 9 perfect-bound
ISBN13: 978-1-886958-24-1
ISBN 1-886958-24-6

Download the Foreword, TOC, and a free chapter of this book

• 17 Chapters
• CLIA Appendix
• Index
• Discussion of all the major trends in laboratory quality management
• Practical guide to the CLSI guidelines, ISO standards, and CLIA Final Rules
• Demonstration of Design tools for every budget

The New Laboratory Economy has entered the Age of Uncertainty

The CLIA "final" rules didn't turn out to be so final; the "Equivalent Quality Practices" that were issued were universally rejected as scientifically unsound and practically unachievable. Risk Management practices may be issued by new CLSI guidelines, but their scope and and intent have changed. ISO standards may soon arrive on US shores - or they may be decades away.

What's a laboratory to do?

In this vital new manual, Dr. James O. Westgard, sorts through all the guidelines, recommendations, trends and fads, distilling the plan for Quality into practical step-by-step directions. Even in the 21st century, Quality can be simple. With the tools and techniques introduced and demonstrated in this book, you can do the Right Quality Right.

Here are just some of the topics covered by Assuring the Right Quality Right:

• CLIA "Final" Rules and "Equivalent QC" options
• Inspection and Accreditation agencies, the impact of going "unannounced" on laboratories
• Risk Management techniques, their scope and applicability
• Six Sigma tools and benchmarks
• ISO 15189 and other standards
• Patient Safety pressures
• Government investigations into the Quality of Laboratory Testing

So what do I really need to do about Quality?

At the nexus of all the rules, regulations, standards, guidelines and best practices, Quality remains paramount. Dr. Westgard shows practical ways to evaluate the indicators, checklists, and benchmarks. He introduces an objective, rational method for managing quality in the laboratory. Finally, he demonstrates practical tools to implement and achieve that level of quality. For every laboratory budget, there is a solution that will improve quality and assure compliance.

Is this book for you?

Do you have to deal with CLIA Final Rules, ISO standards, CLSI guidelines, and/or inspection and accreditation?

Are you responsible for assuring the quality of the processes you perform?

Will you be offering services or products to someone who does?

Assuring the Right Quality Right is a critical look at today's regulatory climate. Every laboratory professional can gain something from these important lessons:

• HOSPITAL AND HEALTH SYSTEM ADMINISTRATORS: gain insight into the regulatory climate/chaos and learn what options you have to manage quality in your institution
  
• CLINICAL LABORATORY ADMINISTRATORS, PATHOLOGISTS, and PH.D.S.: develop new skills and comprehension of quality management systems.
  
• SECTION SUPERVISORS, COMPLIANCE SPECIALISTS and REGULATORY AFFAIRS MANAGERS: acquire new practical tools to streamline your quality improvement efforts.
  
• DIAGNOSTIC MANUFACTURERS, R&D, TECHNICAL SUPPORT, and FIELD REPS: understand the environment of your customers and identify areas where you can deliver truly-valued solutions.

Download the Foreword, TOC, and a free chapter of this book