WHAT'S NEW?WHAT'S NEW?Westgard QC, Inc., is proud to announce the release of our latest software: EZ Rules™ software
(ISBN 1-886958-14-9) is the fastest, easiest way to choose the best control rules for your laboratory tests. Using a built-in Automatic QC Selection engine, EZ Rules™ asks you a few simple questions and then automatically tells you which control rule you should use for that test. It takes minimal user input, just a few questions, to get an authoritative QC recommendation. EZ Rules™ consults an internal library of over 100 statistical control rules, and gives you the option to select Patient Data control rules for Average of Normals.We could go on and on about EZ Rules™, but the easiest way to find out more is to visit
http://www.westgard.com/ezrules.htm
There's complete information about the program, plus you can view a streaming Shockwave video demonstrating the software in action, and you can download the foreword, TOC, and section 1 of the program manual.Basic Method Validation Download:
Now you can download the Foreword, TOC, and Chapter 1 of this popular manual, which was recently called "an ideal learning tool"and "an excellent resource" by Laboratory Medicine.
http://www.westgard.com/basicmvbook.htmBasic QC Practices Book Download:
Thousands have read the book, taken the online course, or used the training CD. Basic QC Practices is an essential reference. Now you can download the Foreword, TOC, and Chapter 1 of this manual.
http://www.westgard.com/basicqcbook.htm(And of course, you can still download the TOC & Foreword of our new manual, Basic Planning for Quality http://www.westgard.com/basicqpbook.htm)
Quality is Job 1 when the Rubber Meets the Road:
Yes, it's a mixed metaphor. It's also an essay about the Ford/Firestone debacle, and what it means for us in healthcare laboratories.
http://www.westgard.com/essay33.htmZ-Stats 14: Estimating analytical errors using regression statistics
In this lesson, Dr. Zady describes practical laboratory applications and some of the complications encountered when working with real experimental data.
http://www.westgard.com/lesson44.htm
Online Courses:
Hundreds and hundreds of people like you -- from across the country
and around the globe -- are taking these online courses for continuing
education credit. Join them!
Basic Method Validation. Everything you ever wanted to know about method validation but were afraid to ask. Learn the inner, hidden, deeper secret meaning behind method validation (i.e. Why the heck do you have to crunch all those numbers, make graphs, and stick them in a folder?). This course covers all the key experiments like comparison of methods, linearity and reportable range, replication, interference, recovery, detection limit, and reference interval. CLIA, CAP-LAP, JCAHO and other regulatory requirements are also explained. An online data analysis toolkit is provided to give you worksheets, experimental plans, and the ability to generate comparison plots, difference plots, linearity plots, histograms, and more online. This course is accredited by the ASCLS for 15 PACE credits. Follow this link to register. THE BMV COURSE IS ALSO NOW AVAILABLE THROUGH THE AACC FOR 15 ACCENT CREDITS.
"Westgard Rules": The Multirule QC Minicourse. The "Westgard Rules" are common in many laboratories, but are often misunderstood and misinterpreted. Finally, Dr. Westgard has developed a course so that you can hear from the horses mouth what the rules are, how to implement them, and how to interpret control data correctly. This is a short essential course for laboratory techs who must use the "Westgard Rules". Online qc tools are used to demonstrate how to implement Multirule QC - a QC simulator, a QC checker, and more. Interactive quizzes help you judge your own progess at every step. This course is accredited by the ASCLS for 5 PACE credits. In just three lessons, you can learn everything there is to know about "Westgard Rules" and know that it was Westgard himself who told you. Follow this link to register.
The Levey-Jennings Minicourse (5 PACE credits):
Here's the fastest way to learn about the Levey-Jennings control chart. Not only do you learn how to construct control charts, plot data on them, and interpret the results,
you also gain access to Internet tools that actually create Levey-Jennings charts to your specifications. You can even test your interpretation of random data through an online QC Trainer. For a short time, the ASCLS has a bargain registration rate:
Special intro rate: $30 for ASCLS members, $60 non-members
After October 1st, $45 for ASCLS members, $90 for non-members
http://www.westgard.com/levjens.htm
http://www.ascls.org/wqc/lj.htmlBasic QC Practices has over 215 laboratory professionals enrolled! There are discounts for site licences and multiple users, as well as undergraduate rates. You get a discount on our Basic QC Practices manual when you sign up! This has everything that the Multirule Minicourse has and much, much more.
Who will care for quality tomorrow?
Dr. Westgard discusses the current shortage of qualified laboratory personnel and what that means for healthcare. He explains why there are so few new MTs and consequently what the future holds for the laboratory workplace.
A Sneak Peek at "EZ Rules"
Those of you who attended the AACC/ASCLS convention know what this is about. Our newest software is easier to use and makes QC planning faster than ever. Get a glimpse of the future of QC planning.
Z-Stats 13: The Least Squares Regression Model
Dr. Zady explains variables both dependent and independent (but not co-dependent), variances both explained and unexplained, and deviations both squared and unsquared.Finally, we want to thank all of you who came to the Westgard Booth at the AACC/ASCLS in San Francisco. It was great to see so many of our website "regulars" and put faces to the emails we've received. Your feedback, comments, reactions, questions, and suggestions are what make this website and this company so great. So stay in touch and stay tuned; the best is yet to come.
By the way, The Basic Planning for Quality Manual proved very popular at the AACC/ASCLS show: it sold out on the second day!
Westgard QC is proud to announce the publication of a new manual: Basic Planning for Quality. If you've been following the website updates for the past few months, you've previewed some of the articles that form the heart of this book. However, the book contains new sections, chapters, and appendices that can't be found on the web. You can DOWNLOAD a copy of the foreword and toc here.
Basic Planning for Quality is a practical introduction to the management and planning of quality control. It's also the first book to use cartoons (specifically, cartoon vikings) to explain quality planning! With the aid of Hagar the Horrible® and more than 65 illustrations, Dr. Westgard dispels the confusion over how to select quality control procedures for laboratory methods. Using a detailed step-by-step planning process, he 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. The tools needed for planning quality are included in the book - including charts of operating specifications, worksheets, and access to graphic online decision-making tools - so as soon as you've read a chapter, you can put it into practice immediately. CLIA requirements, JCAHO guidelines, NCCLS 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 discussion of the financial impact of quality planning. A complete glossary, reference list, online reference list, and a set of self-assessment questions and detailed answers are also included. For anyone serious about managing quality in the laboratory, this is an essential book. And for a limited time, this new manual is available at a special introductory rate exclusively through our website: http://www.westgard.com/order.htm
AACC/ASCLS Conference, San Francisco 23-27: For those attending this meeting, we'd sincerely like you to drop by our booth (#745) and check out our new manual, our new software, and our new online minicourse. Visiting the booth will be the only way to get an early glimpse at the new QC Validator, and the only time of the year when you can leaf through our manuals, check out our videos, and take our CDs for a spin. Plus, we're handsome fellows with great senses of humor. So stop by and have some fun. This is the last time you'll hear about it from us.
QP 15: FAQ's of QP
Dr. Westgard answers some of the frequently-asked questions about Quality Planning, like "Why oh why must I plan QC?" If you don't see the question you'd like to ask about Quality Planning, we encourage you to email us.
http://www.westgard.com/lesson63.htmBack to the Stats! Z-Stats 11: Confidence Intervals
Dr. Zady returns to these pages with a timely discussion of confidence intervals. Do you believe
in the numbers you're producing? Learn the statistical definition of confidence.
The Basic Planning for Quality series wraps up this month with some coagulation test applications. This time, however, instead of using Normalized OPSpecs charts to plan quality for the coag tests, you can use our new online tools! Finally, we're adding a special database of biologic variation for over 300 analytes; this database contains, in addition to within- and between-subject biologic variation data, specifications for desired levels of bias, imprecision, and allowable total error. For those seeking more quality requirements and guidelines, this database may be just the thing.
QP 13: Coagulation Applications
Quality planning isn't just for chemistry. Coagulation analyzers behave just like multitest chemistry analyzers. Dr. Westgard demonstrates how to pick QC procedures for Prothrombin Time, Partial Thromboplastin Time, and Fibrinogen.Quality Planning Tools - ONLINE!
Use our new online tools to plan quality - everything you need is provided! The tools take your input and create OPSpecs charts with your data automatically plotted for your inspection. The online Method Planner helps you establish specifications for bias and CV. The online QC Planner helps you choose the best control rule for your test.QP 14: What's wrong with statistical quality control?
You can't throw stick these days without hitting someone who wants to abolish quality control. Dr. Westgard tackles the arguments used by these grumps and reveals a secret: performing quality control isn't hard, but performing quality control badly is both incredibly difficult and and extremely time-consuming.A Meeting Review
Dr. Westgard recently attended an AACC meeting titled "New Approaches to Quality Control." His summary of the speakers and topics provides a revealing critique of what was actually "new" and what was actually just blather.New database on Biologic Variation
Dr. Carmen Ricos has graciously provided us with her database of biologic variation for over 300 quantities. These tables include within- and between-subject variation, as well as desirable specifications for quality (allowable total biologic error), imprecision, and bias. This is a great new source of information for those seeking guidance in quality requirements!An Award for Basic Method Validation
The Basic Method Validation manual was recently named one of Doody Journal's Annual Best Books of the Year. Many of you might not know what the Doody Journal is - or you might think doody of Doody, but we're happy that someone, anyone, thought it worth a little bit extra attention.
We continue our Planning for Quality series. This month we demonstrate the applications of Planning for Quality in Automated Chemistry, Blood-Gas, and Immunoassay methods -- showing you how to put the planning into practice. If you would like to see more tests, methods, instruments examined on this website, send us an e-mail. We'd be glad to take a look at your suggestions or even your real-world data and show you how you can choose better control rules.
QP 9: Practice makes Proficient
Learn the What, Where, When, Why and How of Quality Planning! Depending on how many of the Quality Planning lessons you've already read, this essay provides an overview, preview, review, or quick refresher of the quality-planning process and the training materials available to support your applications.QP 10: Automated Chemistry Applications
This is the first of several lessons on applications of the Quality Planning process. Using the Quality Planning Worksheet and Normalized OPSpecs Charts (both available for free download on this website), Dr. Westgard shows you how to choose the best QC procedures for chemistry, glucose, chloride, calcium and other methods on automated chemistry system. More generalized advice and strategies for the planning and implementation of chemistry methods are discussed.QP 11: Blood-Gas Applications
Dr. Westgard shows how to plan quality for pH, pCO2, pO2 and other Blood-Gas methods. The differences between the quality of high-volume instrument systems and POC devices is discussed, along with other planning and implementation strategies.QP 12: Immunoassay Applications
Recently Immunoassay applications were called the trickiest methods in the laboratory. Sounds like a quality planning challenge! Dr. Westgard shows that quality can be planned for even the hardest, most difficult methods. Cortisol, thyroxine, and thyroid stimulating hormone examples are demonstrated, along with more general advice on how to handle quality for these methods.Read our Reviews!
The latest review of the Basic QC Practices manual is out, this time found in the American Journal of Clinical Pathology. Every journal that's reviewed Basic QC Practices has loved it - see what Am J Clin Path has to add to the accolades. We've also posted a number of comments from our online course participants -- if you've wondered what people taking the course think, check this page out.Finally, we wanted to let you know we'll be exhibiting at the 2000 AACC/ASCLS Conference in San Francisco July 23-27. Come visit us at Booth 745! We'll be showing off new manuals, new software, new courses, and more.
The Quality Planning Series Continues: Everyone
agrees you should plan quality. But when it comes to how to do
it, there is much debate. How can one plan quality easily, cheaply,
and quickly? We've got everything you need to get started and
we're giving it to you for free: worksheets, planning flowcharts,
OPSpecs charts,
all downloadable and ready to use. Take advantage and start planning
your quality today!
QP 6: Using OPSpecs Charts to plan Quality.
OPSpecs (Operating Specifications) Charts allow you to build your QC requirements right into your quality-planning process. They also take method instability into account and use a very easy, intuitive, and quick graphical method. If you can plot a point on a graph, you can use OPSpecs Charts to plan your quality.
QP 7: Formulating a Total Quality Control (TQC) Strategy
Quality Planning doesn't end when you've found the right QC procedure. You also need to optimize your management of the tests and methods in your laboratory, and learn how to distribute your scarce laboratory resources. Using TQC Strategies will help.
QP 8: Using Normalized OPSpecs Charts to manually plan your Quality
If you don't have software to generate OPSpecs Charts, or lack a reference text of OPSpecs Charts, what do you do? You use the Normalized OPSpecs Charts provided on this website. Normalized OPSpecs Charts are even simpler than regular OPSpecs Charts - and you can get them for free here!
Normalized OPSpecs Charts (a PDF download)
A series of 8 Normalized OPSpecs Charts that you can download to your hard drive and print out as needed. Includes a flowchart explaining when to use each chart. If you use our Javascript calculator, you won't even need to do any math.Quality Planning Worksheet (a PDF download)
This one-page worksheet gives you a jumpstart on planning you quality. All you need are a few
key details (quality requirement, CV, bias) and you can pick QC procedures for any rule.
In the wake of the Abbott-FDA consent decree, we're introducing a new series on Quality Planning. Quality Planning is what builds quality into methods, processes, and instruments from the start. Quality Planning is what will help us all avoid problems with repeat runs, regulatory fines, recalls, and other debacles.
QP 1: A Wake-up call for Quality Management!
What does the Abbott-FDA Decree mean? What was wrong with the quality of all those tests and why didn't any of the laboratories using those tests notice a problem? Dr. Westgard offers analysis, answers, and a roadmap for the future.
QP 2: Assuring Quality through Total Quality Management
There's a way to plan instruments, methods, and procedures so quality is built-in from the start: Total Quality Management (TQM). This triage system allows you to rely on statistical qc for the easy methods, and emphasizez the non-statistical qc components for those harder methods. Dr. Westgard explains how to adopt and apply TQM where you work.
QP 3:Complying with Regulations, Standards, & Practice Guidelines
JCAHO, CLIA, NCCLS - which guidelines define quality in the lab? Dr. Westgard sorts through all the different regulations, recommendations, and emerges with the critical directions.
QP4: Devising a Practical Process
Ok, so we agree that we need to plan quality. But how to do it? Isn't it incredibly complex and consuming and therefore we simply don't have time for it? NO! There's an easy way to plan quality, a step-by-step process that we can use for every test in the lab. Read this to discover it.
QP5: Defining Quality Requirements
Now that we agree that we need to plan quality, and that we've decided on a practical process to do it, there's just one hitch left: Where do we find quality requirements? How do we reconcile CLIA PT criterion, clinical decision levels, analytical quality requirements, biological variation, etc.? What does it mean when a salesman says his instrument is "state of the art"? What state? What art?
Dr. Westgard introduces a system of quality standards to allow you to determine the quality required for every test.
Your Questions Answered!
Here are some of the best questions we received in the last few months, along with Dr. Westgard's answers. Don't see your question? Send it in...
http://www.westgard.com/quest13.htm
The biggest news of the year (so far) is the unveiling of our new online courses, Basic Method Validation, and the Multirule QC Minicourse. Both are available right now from the ASCLS. Get PACE credits, use interactive plotters, calculators and graphing tools, learn something useful, all from the convenience of your own home (or cubicle or workstation or library or laptop...)
Y2K WQC. The year 2000 will bring many changes for Westgard QC. Dr. Westgard explains all the new features, products and services that will come from this website and the company in the coming year. There are plans, priorities and predicaments. We want you to know what we're up to, and we'd love to hear what you think.
Z-Stats 9: Truth or Consequences for a statistical test of significance. How much power does a statistical test have? What do the results of a statistical test mean? Dr. Zady weighs in on this matter and gives you guidance on how you should weigh the results of your tests.
Z-Stats 10: ANOVA. No, this isn't a PBS show, it's the analysis of variance. While this is the statistician's passion, it's a bit less thrilling for laboratory personnel. Dr. Zady simplifies the topic and makes it easier to understand and implement ANOVA in a healthcare situation.
QC Planning for Healthcare Laboratories has ended its online run. Over 135 laboratory professionals enrolled, representing more than 26 countries: Argentina, Australia, Belgium, Brazil, Britain, Canada, Columbia, Denmark, Finland, Germany, Hong Kong, Ireland, Israel, Italy, Mexico, the Netherlands, Norway, Paraguay, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, the United States, and Taiwan. We'd like to thank everyone who participated in the course and gave us feedback to make it better. Over the course of the next year, we'll be revamping the essays and updating them for the new millenium. If you are still interested in taking this course, you can take the course via CD! There's even a special on it this month.
Here are some key articles that went up in December 1999 that we still want to draw your attention to:
The Abbott-FDA Consent Decree. $100,000,000 fine? What's
up? The recent Abbott-FDA Consent Decree
resulted in a $100 million dollar fine because of a long standing
failure to comply with FDA's Good Manufacturing Practices or Quality
System Regulation. How does this affect
you? Dr. Westgard explains how the Consent Decree should alert
laboratories and manufacturers of the importance of an independent
laboratory quality system that assures the quality of routine
test results.
Do's and Don'ts of QC. A primer on how
to avoid excessive repeat runs, inspection failures, and
maybe even larger problems...
Good Laboratory Practice
and CLIA:
This guest essay by Dr. Janine Cook details the obligations of
Good Laboratory Practice and the
government requirements of CLIA. Find out where the two mesh and
where they conflict.
NEW QC TOOLS!!!
We've added new online tools for your use. These tools are in
their beta-testing stage, so we're interested in hearing your
feedback about their use. If you want new features, let us know.
The AUTOMATIC QC
SELECTION ENGINE - A new service from Westgard QC:
QC Validator technology can now be imbedded in instruments and
other software packages. We have developed a "software engine"
that can be imbedded in any Windows program. If you are a manufacturer
or LIS producer, you now have the ability to directly insert Automatic
QC Selection in your current system. If your company is interested
in adding Automatic QC Selection to your list of features, be
sure to read this article.
For all the news that was 1999,
follow this link. We put up a lot of essays,
lessons, etc., last year, and we're proud of the response. Our
website has grown now to over 5,000 visitors a month. We
hope you keep coming back for more.
