Assuring the Right Quality Right
Product Description
2007, 288 pages, 6 x 9 perfect-bound
ISBN13: 978-1-886958-24-1
ISBN 1-886958-24-6
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:
So what do I really need to do about Quality?
ISBN13: 978-1-886958-24-1
ISBN 1-886958-24-6
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
- CLSI guidelines, their new role in shaping the regulatory landscape
- 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.
Do YOU need this book?
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