Basic Planning for Quality

NOTE: CURRENTLY ON BACK ORDER. SHOULD BE BACK IN STOCK MID-OCTOBER.

Product Description
2000, 272 pages, 6" x 9" perfect bound
ISBN 1-886958-13-0

• 15 Chapters
• 4 appendices
• Reference list
• Online Reference list
• Glossary
• Self-assessment questions and answers
• 20+ example applications

A practical introduction to the management and planning of quality control. With the aid of cartoons and more than 60 illustrations, Dr. Westgard dispels the confusion over how to select quality control procedures for laboratory methods.

Using a detailed step-by-step planning process, the author shows you how to define the quality needed for a laboratory test, how you can select control rules for tests, and how you can set specifications for allowable bias and CV. CLIA requirements, JCAHO guidelines, CLSI methodologies and QC practice guidelines are discussed, and more than 20 quality-planning examples are graphically demonstrated covering applications for automated chemistry, blood gas, immunoassay, and coagulation tests.

Appendices include tables of CLIA quality requirements, European goals for total biologic error, as well as a complete glossary, reference list, online reference list, and a set of self-assessment questions and detailed answers.

Basic Planning for Quality is a much-needed primer on the management of quality control in the laboratory. For lab managers and directors, quality specialists, and clinical laboratory scientists who are looking for a saner way to manage quality in their labs, this manual will provide the missing ingredient – an objective way to manage your testing processes to achieve the quality needed for patient care while accounting for the actual performance of the methods in your laboratory.

• Establish a practical process for managing quality in your laboratory!
• Plan your quality logically, efficiently, and quickly!
• Move beyond compliance with JCAHO, CLIA, NCCLS, and other rules!
• Optimize your QC to minimize waste and maximize performance!
• Select the best control rules for your tests!

Basic Planning for Quality makes use of over 65 illustrations, graphs and tables, explains more than two dozen applications in detail, covers CLIA, JCAHO, NCCLS and other requirements, includes appendices on CLIA requirements, European Biologic Goals, and provides a database of quality recommendations for over 300 analytes.

Learning Objectives:

In fifteen chapters, the Basic Planning for Quality manual teaches you how to:

• Define the analytical quality required for laboratory test.
• Utilize charts of operating specifications for quality-planning applications.
• Establish purchase specifications for the imprecision and inaccuracy needed for analytical methods.
• Select control rules and numbers of measurement appropriate for the imprecision and inaccuracy of your method and the quality required in your laboratory.
• Select appropriate Total QC strategies for methods in you laboratory.
• Implement a practical "manual" quality-planning process with normalized charts of operating specifications.
• Utilize online quality plannin tools to speed the quality-planning process.

Reviews

from Archives of Pathology and Laboratory Medicine: Vol. 125, No. 10, pp. 1396-1396.

Basic Planning for Quality: Training in Analytical Quality Management for Healthcare Laboratories

Review by Stephen E. Kahn, PhD, DABCC and Amy Haara, MBA, MPA Maywood, Ill

Basic Planning for Quality: Training in Analytical Quality Management for Healthcare Laboratories provides a practical introduction to quality management and planning with an emphasis on key quality control concepts and issues in the health care laboratory. This is a recent text from an array of educational tools created by Dr James Westgard, an internationally renowned leader in the development and application of quality management principles in health care. More than 15 years ago, Dr Westgard's name became linked to clinical laboratory quality control through his successful efforts to apply multiple quality control rules ("multirules") to clinical laboratory processes. In part through the publisher of this text, Westgard QC, Inc, Dr Westgard has continued to create textbooks such as this product as well as educational programs, software products, and Web-based learning courses. These valuable tools have been used worldwide to facilitate the education of many individuals within health care, and specifically the clinical laboratory, on state-of-the-art practical applications of quality management principles to health care processes.

This book's subtitle identifies directly the nature of the practical information conveyed in the text as well as the audience of readers the book targets. In a clear, concise and "reader-friendly" manner, the author effectively guides the reader through the key steps in quality planning that are relevant to the health care laboratory setting. In achieving this goal, Dr Westgard ensures that the legislative, regulatory, and accreditation body aspects of health care laboratory quality planning and management are also addressed.

This text would most benefit readers who already have some basic knowledge of quality control principles in the health care laboratory. The first 8 chapters systematically develop key issues and considerations in the quality planning process. Each of these chapters generally builds on those that preceded it, and the ninth chapter summarizes and reviews previous major concepts and issues. The next 4 chapters illustrate practical applications to the areas of automated chemistry, blood gas, immunoassay, and coagulation quality planning. The final 2 chapters of this 15-chapter text incorporate frequently raised concerns or questions on quality planning and quality control with the author's useful insights and answers to them. Each chapter concludes with a short list of self-assessment questions, and the answers are available at the end of the text.

As Dr Westgard notes, those who are "eager to learn practical applications and who are more concerned with how to do quality planning than the theory and background" can actually begin with the ninth chapter, briefly review 2 earlier specific chapters on key steps in the quality planning process, and, after studying an application chapter, move on to using the principles for their own applications. The text's appendices summarize recommendations for quality requirements and desirable performance specifications on most routine laboratory procedures; these recommendations are compiled from several key sources, such as the Clinical Laboratory Improvement Amendment of 1988 (CLIA'88) regulations. There is also an appendix addressing financial implications of quality planning. Finally, the text also provides readers with information and guidance to access online quality planning tools available on the Internet.

As health care continues to evolve through a challenging period of regulatory proliferation and financial constraints, it has become increasingly difficult, though no less critical, to ensure quality in laboratory testing. This recommended text is a valuable and worthwhile addition to the library of any health care laboratorian who is responsible for quality planning. It should greatly benefit those interested in enhancing their skills in the development and application of practical quality management concepts to the workplace setting of the health care laboratory.

Reprinted with permission of the Archives of Pathology and Laboratory Medicine

from AACB Newsletter, September 2001:

Reviewed by Les Watkinson

It is obvious to those who study this book that James Westgard has never taken a course in statistics, and that his ability to stir up trouble in the laboratory is probably due to his ancestral lineage that closely relates him to Hagar the Horrible. These are not my conclusions they are facts clearly stated by Dr Westgard, and if Dr Westgard is related to Hagar the Horrible then the book also serves as a family photograph album of the Westgard ancestors.

Basic Planning for Quality is not so much a reference book but more a study course that also provides access to QC tools from the Internet. There are 15 chapters which are better described as lessons, each beginning with a short study plan that includes the goals for the lesson, specific objectives, material to study and things to do. Each then concludes with a short list of self-assessment questions. The book aims to teach the reader how to

• Define the quality required for a test,
• Establish the purchase specifications for imprecision and inaccuracy for new analytical methods and systems,
• Select QC procedures that maximise quality and minimise cost, and
• Formulate an overall or total QC strategy that balances statistical and non-statistical components in a quality system.

For those who cut their QC teeth on Westgard Multi-Rules, we learn from this book that Westgard Rules are not OK or rather that there is more to quality control than multi-rules and subsets of multi-rules are often more appropriate. We are introduced to OPSpecs charts that are used to plan the quality of a laboratory test and direct us to which rules are the more appropriate for each method. Individual chapters cover the planning of quality for, chemistry methods, blood gas methods, immunoassays methods and coagulation methods. The final appendix to the book deals with the financial impact of quality planning and strong cases are made that show the implementation of a quality planning process can actually save money.

As one would expect from a book that is directed towards USA laboratories it bases the implementation of a quality planning process on the regulations, standards and practices recommended by the Joint Commission for Accreditation of Health Care Organisations (JCAHO), Clinical laboratory Improvement Amendments (CLIA-88) and the National Committee for Clinical Laboratory Standards (NCCLS). However if your laboratory is not required to meet CLIA acceptability and/or if you prefer quality requirements based on biological variability, then you will find that the quality planning process works with any total error requirement, and there is a list of desired specifications for total error, imprecision and bias derived from biological variation, for the reader to use.

For anyone who wants to learn the practical applications of planning for quality it is a book of many parts. It is a reference book, it is a planning manual, it is a study course and it gives access to Dr Westgard's website and the world of quality.

Maybe by working through this book Lucky Eddy will learn to understand Hagar the Horrible and hopefully put into practice what he has learnt. Who knows he may also get a promotion.

ISBN 1-886958-13-1
Published by Westgard QC, Inc., 7614 Gray Fox Trail, Madison, WI 53717, USA

Westgard QC, Inc. copyright 2008
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