The Westgard Rules

New Book: The Poor Lab's Guide to the Regulations

Posted by Sten Westgard, MS

Declare your Independence from the Fear of Inspection:

By Dr. Sharon S. Ehrmeyer, Ph.D.

In 9 concise chapters, Dr. Sharon S. Ehrmeyer, Ph.D., describes a common-sense path to compliance:

•  An overview of regulations from CLIA, CAP, TJC, and COLA
•  Proficiency Testing
•  Procedure Manuals
•  Method Verification, Calibration and Calibration Verification
•  Quality Control for the small laboratory
•  Quality Assurance
•  Personnel Competency Requirements
•  Inspection Tips, Tools for Self-preparedness
•  Point-of-Care testing requirements, EQC and the future

For decades, Dr. Ehrmeyer has been guiding laboratories in their compliance efforts. She speaks frequently on CLIA, CAP, The Joint Commission, and COLA. Her down-to-earth advice has made her a favorite at conferences around the world. Now all of her recommendations (and more) are available in this reference manual.

 More than 250 years ago, Founding Father Benjamin Franklin published "Poor's Richard's Almanack," a compilation of practical tips and words to the wise. His bestselling book spoke to the growing spirit of self-reliance and independence in America. Continuing in this tradition, the Poor Lab's Guide is an essential collection of pragmatic wisdom for the American laboratory.

Try the Guide
Find out more and Download the Foreword, Preface, TOC, Index and sample excerpts at
http://www.westgard.com/guide-sample.htm


Introductory Special:
 Save $15 off the cost of this manual with the online coupon: LABFREEDOM.
 Order at http://www.westgard.com/the-poor-labs-guide.htm store before July 31st to take advantage of this discount.

Westgard workshops and books at AACC/ASCLS Los Angeles

Posted by Sten Westgard, MS

At this year's AACC/ ASCLS meeting in Los Angeles, there are more opportunities than ever to attend a workshop with Dr. Westgard (or myself). There's even a special event where you can receive a signed, complimentary book!

Click the links below to find out more or register for these events.

Tuesday only, July 17th: At the SeraCare (Booth #804), Dr. Westgard will be signing copies of Basic QC Practices, Basic Method Validation, and Six Sigma Risk Analysis. For a limited number of visitors, these books will be FREE! (First-come, first-served, Tuesday only).

Tuesday, July 17th, 7:00 am: Sigma-metric Driven Quality Managment in the Clinical Laboratory
 Dr. Westgard, Dr. Litten of Winchester Medical Center, Winchester, VA and Dr. Khosrow Adeli, University of Toronto, Ontario, will discuss Six Sigma tools and their applications in real laboratories.


Tuesday, July 17th, 6:00 pm: Quality control for the Future series: Risk Management EP23 for Laboratories
Dr. Westgard and Dr. Curt Parvin of Bio-Rad Laboratories will discuss the new Risk Analysis techniques.


Wednesday, July 18th, 6:00 am: Vitamin D Testing - Bringing Performance and Quality to the Lab
Dr. Hossein Sadrzadeh of Cedar-Sinai Medical Center LA, Cynthia Johnson of the University of Minnesota Medical Center, will show data from their studies of new authomated 25-OH D immunoassays. Sten Westgard will place performance in context with Sigma-metrics, evidence-driven quality requirements, and provide recommendations for QC and reporting optimization in the laboratory.

Westgard QC will also be exhibiting at Booth 951. We will be demonstrating software, displaying our reference manuals, and debuting a new book (whose title and topic will remain a mystery for now...) And of course the infamous "Westgard Wear" raffle will be held.

[note: as you might expect, Dr. Westgard's lecture at the Abbott Diagnostics industry workshop will be sponsored by Abbott Diagnostics. Dr. Westgard's lecture at the Bio-Rad industry workshop will be sponsored by Bio-Rad. Dr. Westgard's appearance at the SeraCare booth will be sponsored by SeraCare, etc.]

Basic QC: now in Korean!

Posted by Sten Westgard, MS

We recently had the pleasure of working with Koonja Publishers in South Korea.

They have translated the Basic QC Practices, 3rd edition manual into Korean and are now making it available for sale: http://koonja.co.kr/shop/goods/goods_view.php?goodsno=14152

Here's a glimpse of the cover:

This is an official, authorized translation. This book has previously been translated into Spanish.

Thanks to Koonja for this important project.

AACC Convention: Joan Gordon and Clark Rundell

Posted by Sten Westgard, MS

Pictured Above: Joan Gordon MT(ASCP) and Clark Rundell, PhD of Main Molecular Quality Control

Joan and Clark were key authors in the third edition of Basic QC Practices. Their contributions for the chapter on Molecular QC - and their help in getting additional authors to contribute - made for one of the most important new additions to the manual.

the practice of quality control in molecular and genetic testing is a new frontier. We hope that with Joan and Gordon's help, we can start to explore what's going on in this area of testing and see what improvements are necessary.

See you at Anaheim AACC/ASCLS, Booth 6708

Posted by Sten Westgard, MS

Next week, July 25th through 29th, the staff of Westgard QC will be in Anaheim for the AACC/ASCLS convention. We'll be at BOOTH 6708.

Among other things, we will have copies of the new Basic QC Practices, Third Edition, manual. The AACC expects to have the Spanish Translation of this title available, both in book format and on CD. So there will be some special events involving the new book, including autographed copies available at the Van Slyke auction, raffle prize giveaway at some booths (check with us for details), etc.

We will also be demonstrating our EZ Rules QC Design software as well as our new online courses at http://www.westgard.org We will be offering registration specials for training, as well as coupons for the books and software available to attendees.

We will also be holding our annual "Westgard Wear" Raffle, a rare opportunity to win such items as a "Westgard Rules" baseball cap, shirt, or messenger bag. These items are not sold in stores (no store is willing to sell something this strange). Nor will these items be understood by the general public if you wear them. But for those seeking rare laboratory apparel, it doesn't get more obscure than this.

We also will have Special Discounts available at the show - but to find out how good those specials are, you have to visit us at the booth. Continuing the tradition from last year, however, we will also have a set of specials available online:

• Special #1: Use coupon code WISHYOUWEREHERE and you'll save $15.00 off any order at our online store
• Special #2: Use coupon code BETTERTHANATEESHIRT and you'll save $25 off any order over $100 at the online store
• Anyone who downloads, places an order, or simply sends us an email at [email protected] will be entered in the Virtual Westgard Raffle. Three lucky winners, chosen at random at the end of the raffle period, will win a Westgard hat, shirt, or bag. These unique items are not sold in stores - no store would have them. But for those who like obscure laboratory gear, there's nothing more obscure.

Fine Print for Special #1: one coupon per order, per customer, cannot be combined, online store only, special starts Wednesday July 21st and ends August 10th.

Fine Print for Special #2: void where prohibited, one entry per person, we cannot calculate odds of winning because we have very little idea of who will enter during this week. Again, this will end on August 10th.

Fine Print on the Fine Print: Why will the non-show specials last longer than the actual convention specials? Call it the AACC Show Hangover Effect. We'll be tired after the convention and need a few extra days to recover.

We'll post details from the convention next week.

Is this Basic Better?

Posted by Sten Westgard, MS

Now that the third edition of Basic QC Practices has been published, there is the inevitable question for readers who purchased the second or even the first edition of the book: is this new edition worth the upgrade?

Just to review the history of publication: the first edition came out in 1998, the second edition came out in 2002, and now, eight years later, we have come out with the third edition.

Anyone who has been to college recently, or footed the bill of a child in college, knows that textbook prices have been getting higher every year, and that textbook publishers are quick to release a new edition. At Westgard QC, we don't try to churn out new editions every other year. As it happens, one of my first jobs out of college was at a college textbook publisher. It was a sobering experience, because it was clear that new editions were being published solely to make the previous edition obsolete. In that way, publishers could prevent their profit margins from being eroded by the re-sale of textbooks.

That's not what we do here at Westgard. The new edition was really overdue.

Here are just three examples of what was removed from the old second edition:

• Chapter 18: computer technology for selecting the right QC. We removed the discussion of software tools. In the new edition, we now explain how to use a manual tool that readers can download. This should provide a more accessible design tool that can be immediately used (and has no additional cost to the reader)
• Chapter 19: computer technology for implementing QC right. We removed this list of QC software packages. In the intervening 8 years, most of the QC charting programs have been lost, so to speak. Even our own charting program, EZ Runs, was purchased and absorbed into Bio-Rad's software offerings
• Glossary, Reference List, and Self-Assessment Questions and Answers. While these are valuable, they take up a lot of space in the book. In the third edition, we have moved these to an online section available to readers, and freed up the space to add new chapters

These are some of the major changes. Several other chapters were cut as well, replaced by more up-to-date discussions of Quality Systems, ISO, QC Frequency, and more.  To see what was added in the third edition, visit the Basic QC Practices, Third Edition homepage.

Basic QC in Spanish Translation

[Posted by Sten Westgard, MS, from the AACC Press Release]

AACC Publishes Basic QC Practices in Spanish

Washington, DC, June 2nd, 2010 

The American Association for Clinical Chemistry’s publishing arm, AACC Press, announces the publication of its first book in Spanish: Basic QC Practices: Training in Statistical Quality Control for Medical Laboratories, 3rd Edition by Dr. James Westgard.  The book will also be published in English by Westgard QC.  A world-wide authority on QC, Dr. Westgard is the co-founder and principal in Westgard QC, which provides training, technology and tools for laboratory quality management.  He is also an Emeritus Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School.  His research focused on performance validation of laboratory methods and most recently on statistical quality control. Dr. Westgard is the author of nearly 200 publications, including eight books on laboratory quality management and has received numerous awards, including several from AACC.

This seminal QC work updates key issues in quality and includes added chapters on Equivalent QC, EQC Evaluation Protocols, and Risk Assessment; new analytics of QC for molecular diagnostics, virology, genetics, and cancer markers; and updated coverage of CLIA, CAP and Joint Commission requirements.  The Spanish translation differs slightly from the English edition to reflect the differences in practice and regulation between the United States and Latin America.  AACC will distribute copies of the book in Latin America and it will be available on its website in late July.

This translation was made possible by a gift to AACC from the Wallace H. Coulter Foundation to support educational projects in emerging countries.  Wallace H. Coulter was an innovator, entrepreneur and founder of the Coulter Corporation.  He revolutionized the practice of hematology and laboratory medicine and pioneered the fields of flow cytometry and monoclonal antibodies.  The Coulter Principle, or electronic sensing zone, was the first of his 82 patents. Its initial application, the Coulter Counter, provided the first high-throughput, standardized method to count and size cells and particles as they flow through an aperture.  It led to major breakthroughs in science, medicine and industry.

Place a pre-order for the Spanish version of Basic QC Practices, third edition. (ships late July 2010)

Order the English version immediately through Westgard QC.

For more information about AACC or AACC Press, contact Peter Patterson on either of the above phone numbers or at [email protected].

 

New Book: Basic QC Practices, Third Edition

Posted by Sten Westgard, MS

The best book on QC just got better.

For more than a decade, thousands of laboratory professionals have made Basic QC Practices their standard reference on quality control.

In this new edition, Dr. James O. Westgard and colleagues have significantly expanded their coverage of the latest issues:

• Comprehensive discussion of the Total Testing Process, including Pre-Analytic, Analytic and Post-Analytic sources of errors
• Added chapters on Equivalent QC, EQC Evaluation Protocols, and Risk Assessment
• New analytics of QC for molecular diagnostics, virology, genetics, and cancer markers
• Updated coverage of CLIA, CAP, JC requirements
• All of this, plus the best lessons on quality control, Levey-Jennings control charts, trouble-shooting, and "Westgard Rules"

Click here to download a free preview of the Basic QC Practices, Third Edition manual, including the Preface, TOC, Index and chapter excerpts.

Basic QC Practices, Third Edition
2010, 352 pages, 6" x 9" perfect bound
ISBN 1-886958-07-6
ISBN-13  978-1-886958-07-4

If you order online now, you can save $15 off the list price, using the online coupon code: BQC3ED
[the fine print: online store only, one coupon per customer, per order, cannot be combined with other offers, expires May 31st]

Read chapter excerpt: Pre- and Post-Analytical Quality

Read chapter excerpt: QC for Molecular diagnostic testing

Order now

Talking about a Training Trilogy in MLO

By Sten Westgard, MS

Dr. Westgard is the featured executive profile in the November 2008 issue of Medical Laboratory Observer. The editors asked him how he developed three popular training references: Basic QC Practices, Basic Method Validation, and Basic Planning for Quality.

CLIA at 20

posted by Sten Westgard, MS

This week, AACC is going to host an audioconference on the latest update of CLIA. We're celebrating 20 years of CLIA in 2008.

Over at the online store, you can celebrate by saving $20 off the price of the CLIA Final Rules manual.
Use the coupon code clia20 during the checkout and you'll save $20.

This offer will run from now (October 6th) until Halloween - that's more than 20 days of savings.