The fastest, easiest way to select the best QC rules!

The laboratory has entered a new era of uncertainty.

Today's Laboratory Manager faces a bewildering array of laws, guidelines, and standards. Are you going to be able to read all the CLIA Final Rules, EQC protocols and options, CLSI guidelines, ISO standards, Risk Managment formulas, Patient Safety Goals and the acceditation and inspection checklists and procedures? If you can, congratulations. You're probably the only one.

For the rest of us, there's Assuring the Right Quality Right. This compact manual provides a practical "crosswalk" of all the regulatory documents and management trends, noting areas of convergance and zones of confusion. But more important than that, Dr. James O. Westgard devotes his expert judgement to providing concrete, realistic recommendations. If you're looking for a source of Best Laboratory Practices that will also fulfill compliance needs, look no further.

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

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With the publication of the CLIA Final Rule and the Interpretive Guidelines in the State Inspector's Manual, the landscape of the healthcare laboratory has once again been profoundly changed. New method validation requirements have altered the responsibilities of laboratories and manufacturers. New guidelines for "equivalent QC procedures" challenge the laboratory to take responsibility for the quality of testing.

With new regulations compounded by new interpretive guidelines, questions remain and confusion reigns.

In this new manual, Dr. James O. Westgard and colleagues will help you identify the impact of the regulations on your laboratory.

CLIA Final Rules for Quality Systems is more than a compliance manual. It identifies the specific regulations, then takes the discussion one step further, to the reasoning and logic that shaped CLIA. Readers will gain not only a grasp on the regulatory details, but a broader understanding of the key concepts of quality control, method validation, and even Six Sigma quality management.

2004, 225 pages, 6" x 9" perfect bound
ISBN 1-886958-20-3

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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.

2004, 258 pages, 6" x 9" perfect bound
ISBN 1-886958-21-1

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Revised, Updated. Expanded. Essential.

Six Sigma Quality is an advanced technique of improving processes and profitability that has revolutionized industries across America and around the world. The facts are plain: by improving quality with Six Sigma techniques, businesses have been able to save billions while gaining a competitive edge. In this book, Dr. Westgard shows you how to apply the Six Sigma techniques to laboratory testing processes.

Section 1 deals with Six Sigma methods and metrics - how to characterize a process in order to compare your performance with world class quality. Section 2 describes tools and technology for Six Sigma design and control. Section 3 illustrates the application strategies for complicated laboratory services such as multitest automated systems, cardiac markers in a POC setting, new-born screening, and patient data for laboratory QC. The last section discusses obstacles and obstacles in implementing Six Sigma Quality Management. It covers the different management theories and approaches, including Patient Safety, ISO guidelines, Lean, and Risk Management, as well as the confusion and chaos of the CLIA regulations. Finally, this book includes a series of financial worksheets to help you assess the current state of your laboratory testing processes and the cost savings that may be possible through Six Sigma improvements.

2006, 348 pages, 6" x 9" perfect bound
ISBN 1-886958-23-8

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

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Praised by every reviewer as an essential reference, the Basic QC Practices manual is now available in its Second Edition. With 8 new chapters, more than 100 more pages, and over 120 charts, tables, graphs and illustrations, it's better than ever. New topics are covered in the second edition, including: Point-of-Care Testing and Physician Office labs; Electronic QC and the Total Testing Process; External Quality Assurance, Proficiency Testing and Peer Comparison; Software tools for QC design; Software tools for QC Implementation; What's the "State of the Art" of QC?; What's in the future for laboratory QC.

Basic QC Practices is still true to the fundamentals of the laboratory. The text includes thorough explanations of Levey-Jennings control charts; the multirule QC procedure ("Westgard Rules"); interpreting control data; responding to out-of-control situations; determining and meeting quality requirements; choosing control materials; calculating mean, CV, and standard deviation. Self-assessment questions and answers, interactive exercises, glossary, references, and links to online graphing tools make this book the gold standard for QC.

2002, 340 pages, 6" x 9" perfect bound
ISBN 1-886958-17-3

First Edition is no longer available
ISBN 1-886958-09-2

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Patented Automatic QC Selection Process!
QC Validator 2.0 automatically selects control rules and control measurements to meet your laboratory's quality requirements.  With just the click of a button, you'll discover the most cost-effective control rule and N that guarantees the quality of your test methods. You can examine the performance of individual control rules - or you can let the computer do the work for you. The program comes with settings for 1, 2 and 3 control materials per run, as well as the ability to customize the number of control materials, QC Selection Criteria, and QC Selection Logic. The program uses computer-executed logic in choosing appropriate control procedures based on the quality required by CLIA-88 PT criteria. The software runs on a 386 PC or higher and Windows 95, 98, 2000, NT, XP or later, requiring 2MB of RAM and 1MB of hard disk memory.

Direct download of QC Validator 2.0 is available now. A completely electronic option, this package does not include a program manual, but you will of course have access to the extensive HELP utility and 5 interactive tutorials.

1996, PDF program manual, program disk
ISBN 1-886958-05-X

PLEASE NOTE: THIS PRODUCT IS NO LONGER AVAILABLE

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The next generation of QC charting is here. EZ Runs(tm) offers multirule ("Westgard Rules"), multilevel, and multistage QC design; flexible setting of means, SDs, and control limits (user-assigned or calculated by fixed interval, moving interval, or cumulative-to-date); automatic flagging and logging of control rule exceptions and corrective actions; the largest choice of control rules (over 100 single-rule and multirule combinations); traditional Levey-Jennings chart display as well as MultiChart(tm) display - where all controls, all levels, all control rules are easily displayed and interpreted on one screen. All of this comes with an EZ interview mode, on-screen advice, and in-depth Help.

Advanced optional features include embedded Automatic QC Selection with EZ Rules(tm), direct data import from hundreds of instruments using Instrument Manager(tm) from Data Innovations, Inc.

EZ Runs(tm) software runs on a Pentium or higher, Windows 95, 98, 2000, NT, XP or later, 32 MB RAM, and requires 45 MB of hard disk memory.

2002, perfect bound program manual, program CD
ISBN 1-886958-18-1

PLEASE NOTE: THIS SOFTWARE IS NO LONGER AVAILABLE
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