WHAT WAS NEW in 2005?WHAT WAS NEW in 2005?Westgard Workshops 2006
Westgard QC is proud to announce our public workshops for 2006 to be held in Madison, Wisconsin, June 5th through 7th.
June 5: Standards and Practices, Guidelines and Indicators - The Lab in 2006
From unannounced inspections, checklist changes, and the risk of EQC, a panel of experts will help you navigate the new laboratory landscape
June 6-7: Evidence-Based Quality Management
International experts from academia and industry will help you find the evidence in your own lab about quality performance - and show you how to base your management practices on it.
Early registration and group discounts are available now
Patient Safety: Can we get there from here?
Our second lesson on Patient Safety examines the traits of an ideal safety culture - and compares current laboratory practices to those ideals. Does "lab culture" measure up to "safety culture"? What prevents us from reaching the ideal safety culture?
Interview: Dr. Jan Krouwer on Risk Management
Dr. Jan Krouwer, author of Managing Risk in Hospitals, talks with us about Risk Management basics - and their implementation in the clinical laboratory.
100,000 miles to Quality: A year in review
Over the course of 2005, Dr. Westgard visited a dozen countries and over a dozen cities just here in the US. At the end of his travels, he sends out thanks to countless individuals who came to listen, to talk, and to enrich the dialog on quality.
Seasons Greetings
As the year draws to a close, we send out our wishes for peace on earth, good will to all, to our colleagues and friends around the world. Thanks for taking the time to visit Westgard Web. And thanks for making quality a part of your laboratory.
Happy Holidays,
James O. Westgard,
Sten Westgard
Joan Westgard
Lab Mistakes Threaten Credibility, Spur Lawsuits
This article in the LA Times, by Walter F Roche, Jr, quotes Dr. Westgard from his talk at the G-2 preconference workshop on Maryland General. Mr. Roche originally "broke" the story on Maryland General while he worked for the Baltimore Sun.
What are the Risks of Risk Management?
Risk Management is coming to laboratory medicine, possibly to a regulation near you. As we learn about the principles, tools, and processes of RM, let's also take time to evaluate the risks.
Is Bad QC just a technicality?
If we say reduced QC is actually equivalent QC, does it matter that this isn't true? In an era where telling the truth can be hazardous to your career, it's time to take stock of the state of truth here in the lab.
CAP on Proficiency Testing
We've said a lot about proficiency testing data in the last year. But what do the PT providers say about their data? We asked CAP to comment on the quality of their proficiency testing.
Lean in a Lab: One Hospital's Experience
Baptist Medical Center South is a brand new hospital in Florida. When they designed the hospital, the laboratory manager had the opportunity to design the lab from the ground up. See how her implementation of Lean techniques affected the layout, staff, and efficiency of her lab.
Patient Safety: What's the culture in the lab?
You may already know that Patient Safety is an important "new" concept in healthcare. It's a hot topic in articles, at conferences, and new institutions have been created and new laws have been passed just to promote Patient Safety. So where does the lab fit in?
http://www.westgard.com/lesson81.htm
ISO 15189: Policies and Procedures
In conjunction with Dr. Westgard's lectures, Mr. Greg Cooper, head of Clinical Standards and Practices at Bio-Rad, made presentations on ISO 15189. We are grateful to him for allowing us to make that presentation available on this website as well.
http://www.westgard.com/iso5.htm
Links to India, Part I and and Part II
Dr. Westgard recently returned from a four-city tour of India. As a way of thanking his gracious hosts, and letting the rest of us know what he was doing, he provides some extra details on his time in this burgeoning laboratory marketplace.
http://www.westgard.com/essay83.htm
http://www.westgard.com/essay85.htm
Method Performance & Test Quality: Same thing?
A question that often comes up when Dr. Westgard speaks: What’s the difference between the quality of a test and the performance of a method? (Would it surprise you to learn that manufacturer claims aren't always produced in routine laboratory operation?)
http://www.westgard.com/essay84.htm
Quality Management Cocktail: ISO, Lean, and Six Sigma
What are the new approaches to quality management? How do they work? Do they have anything in common with each other? If we combine them, do we have a "drug cocktail" for the problems that plague healthcare management? These are the questions we brought to a recent AACC EduTrak.
http://www.westgard.com/guest30.htm
From Method Validation to Sigma metrics: Evaluating a Vitros 5.1 FS
One of the papers at the AACC convention poster session provided us with a great set of data on CV and bias for a new chemistry instrument. From that data, we can evaluate the Sigma performance and the QC required by the instrument. We can even compare the new instrument with Sigma metrics from other competing instruments.
http://www.westgard.com/qcapp32.htm
The Quality of Proficiency Testing Metrics
In our series on the Quality of Laboratory Testing, we've been looking at as many PT groups as possible. But the question arises, are some PT group estimates better than others? We take a closer look at CAP PT Sigma metrics.
http://www.westgard.com/essay82.htm
The Quality of Coag Testing
Over a dozen companies are making POC devices to perform coagulation testing. But what quality is being achieved by the current laboratory systems - and can we expect better quality from the POC instruments?
http://www.westgard.com/essay81.htm
The Quality of PSA Testing
For many men, a PSA test is a prelude to biopsy. But even the man who created the PSA era has recently said that the test is "all but useless." See if the quality of PSA testing has anything to do with the usefulness of this test.
http://www.westgard.com/essay79.htm
Westgard QC extends its thanks to the hundreds who braved the stifling heat and humidity of Orlando to visit us at the festival of abbreviations. Amidst the largest exhibition of diagnostic companies (and the circus of freebies and gimmicks that implies), we were very happy to receive your visit.
Dr. Westgard was also pleasantly surprised to receive the 2005 Outstanding Contributions to Management Sciences Award from the AACC Management Sciences Division.
Here are the winners of the annual "Westgard Wear" Raffle:
Shirts:
- Carla Cuthbert, Dr. John MacDonald Center, Miami, Florida
- Pat Reed, University of Vermont, Burlington, Vermont
Messenger Bags:
- Holly Faby, Memorial Hospital West, Pembroke Pines, Florida
- Sonja Nehr-Kanet, Idaho State University, Boise, Idaho
These prizes have been shipped out to the winners. Thanks to everyone who entered.
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This 10' x 10' space was home for three days. Many a demo was given. Many a brochure was handed out. |
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Dr. Westgard was pleased to speak about "Equivalent QC" at the Bio-Rad booth during the convention. |
The Current State of CLIA EQC
The recent news on Equivocal QC has not been supportive of options 1, 2, or 3. Professionals, manufacturers, even the regulators themselves are unhappy. We're pleased to provide a summary of what's being said and by whom, as well as what that means for you. And find out if these options are now optional - or simply obsolete.
http://www.westgard.com/cliafinalrule13.htm
Back to the Future: CLIA EQC Option 4
A recent meeting held by the Institute formerly known as NCCLS (now CLSI) proclaimed EQC as the "QC for the Future", then promptly proposed a new option that would replace thecurrent options. Even more interesting, the new option comes out of CLIA's past...
http://www.westgard.com/cliafinalrule12.htm
Westgard QC at the AACC/IFCC/ASCLS Exposition
Westgard QC will be exhibiting at this year's conference of the acronyms ( AACC/IFCC/ASCLS ) in Orlando, Florida, July 24-30. We invite you to visit us at Booth 1213, right up front. Drop by for a "Westgard Wear" raffle, see our new products, tell us a joke, and (how exciting) take some of our brochures!
ISO 14001:2004
Can labs evolve into centers of sustainable development? ISO thinks so. See the new standards on Environmental Management Systems (EMS). (Thanks to Dr Rabelo and Dr. Perigo for providing this article.)
http://www.westgard.com/iso4.htm
A Review about Nothing
Clinical Chemistry has reviewed Nothing but the Truth about Quality Control: "A major concern about this book is that it mixes science and social values..." Read the whole review about the Truth and see if you agree.
http://www.westgard.com/truthbook.html#review
Why you haven't heard from Westgard Web lately
If you've been getting the Westgard Web newsletter for a while, you might have noted its recent absence from your mailbox in the past few months. It's not that Westgard Web has gone away - we were just rather busy. Dr. Westgard has traveled to Finland, Belgium, Scotland, Slovakia, the Czech Republic, and France (not to mention another half dozen trips here in the US). Now that he's back in the US in one spot for a while, the newsletter frequency will pick up.
Have you heard of IQLM? It's a new US organization: the Institute for Quality in Laboratory Medicine. 2005 is their inaugural conference, and they used this opportunity to honor "ten visionaries pursuing quality improvements for laboratory tests and services."
Dr. James O. Westgard, PhD, was recognized for Improved Quality Processes for the laboratory. We also congratulate the other distinguished award winners: Brent James, MD, M. Stat (for Excellence in Quality of Care); James P. Bagian, MD (for Patient Safety); Carl Wittwer, MD, PhD (for Technical Advancement); Peter J. Howanitz, MD (for Improved Quality Processes); Michael Laposata, MD, PhD (for Improved Clinical Integration); Dennis S. O’Leary, MD (for Organizational Leadership); Kenneth W. Kizer, MD, MPH (for Organizational Leadership); George D. Lundberg, MD (for Career Leadership); and David M. Eddy, MD, PhD (for Distinguished Achievement).
In recognition of their excellence in practice, the IQLM presented each honoree with a specially commissioned crystal award created by Fräbel Studio, whose work is collected by Queen Elizabeth II, Monaco’s Prince Rainier, and the Smithsonian.
According to IQLM, this organization "is a new public-private partnership organization being formed to engage the health care community in improving the use of laboratory tests and services. The IQLM will be the first organization bringing together clinicians, laboratory professionals, patients, manufacturers, government and accrediting bodies to work on advancing substantial improvements in quality, effectiveness, safety and appropriateness for the broad universe of laboratory testing."
We hope IQLM can be a source for positive change, reform, and improvement. We dearly need such an organization today.
An additional honor was conferred upon Dr. Westgard in April. He was named one of the Top Ten Persons in the IVD Industry by the April 2005 IVD Technology magazine. Here's some of the description of this selection:
"The following list presents 10 persons who have made a significant impact on the IVD industry. IVD Technology’s editorial advisory board and reader board members were first asked to nominate potential candidates for this list. The board members were told that potential nominees should be those persons who have had a considerable influence on the IVD industry. The board members were then asked to select from the compiled list of all the nominees those persons who they thought should be on this final list. Efforts were made to ensure that this list reflects contributions in both the regulatory and scientific areas."
The Quality of Glucose Testing
An analysis of over 9,500 laboratories in 5 different PT organizations reveals the difference between optimistic claims and actual achievements.
http://www.westgard.com/essay75.htm
The Quality of Calcium Testing
A recent NIST/Mayo Clinic study found that even a small calibration error/bias of only 0.1 mg/dL could add up to $60 million in healthcare costs. So what is the quality of calcium testing in the US, and what does it cost?
http://www.westgard.com/essay76.htm
Blowing the Whistle on the Tip of the Iceberg
The Maryland General lab is back in compliance. So we can breathe easier, right? Actually, no. Three other labs have been found with violations. Why are more labs in Maryland having problems? Is this "scandal" still growing?
http://www.westgard.com/essay77.htm
CLIA Final Rule for Quality Systems - Interpretive Guidelines and Inspection Issues
June 27, 2005 * Madison, Wisconsin
The CLIA Final Rule and its Interpretive Guidelines have changed the landscape of the healthcare laboratory.
New method validation requirements and changes in quality control requirements and procedures will shift and alter the responsibilities of laboratories and manufacturers. In the face of these new regulations, confusion and questions remain.
Come join a discussion of these issues with Dr. James O. Westgard, PhD, and an outstanding group of scheduled speakers:
- Nancy Yernasian MT(ASCP) of CAP
- Joanne Born MT(ASCP) of JCAHO
- Sharon Erhmeyer, PhD, MT(ASCP) of UW
- Ronald L. Laessig, PhD of UW and WI State Lab
- Teresa P. Darcy, MD, FASCP of UW and UWHC
Attend and get answers to your questions about the Final Rule, the Interpretive Guidelines, and laboratory inspections. Included with your registration will be a new book, The CLIA Final Rule: Quality Assessment Issues and Answers.
Six Sigma Quality Design and Control
June 28-29, 2005 * Madison Wisconsin
Six Sigma is now well known to healthcare. Hospitals, Reference Laboratories, and Diagnostic Manufacturers are either contemplating its use, or are implementing it somewhere in their business. By dramatically reducing errors and defects, these companies have made strategic quality improvements and improved their efficiency and profitability. If you haven't learned about Six Sigma yet, it's time. If you know Six Sigma, it's time to learn how it applies to analytical testing processes. Few realize it, but the core process for laboratories is the best target for Six Sigma improvements.
In a relaxed, retreat-style setting, Dr. Westgard introduces the basics of Six Sigma:
- Determine the Sigma performance of your tests;
- Select QC procedures appropriate for your Sigma metrics;
- Assign staffing and resources on the basis of Sigma performance;
- Prioritize process improvement efforts and resources.
Using real-world applications of Six Sigma quality improvement and with demonstrations of the impact of Six Sigma on costs and instrument design, Dr. Westgard will teach advanced Six Sigma QC techniques. Participants will not only learn the skills needed to become leaders in the new laboratory economy, they'll also walk away with a set of software tools to immediately implement Six Sigma in their own workplace.
Seating is limited, so early registration is encouraged. (Last year's workshops sold out)
There are early registration discounts, as well as additional discounts for multiple registrations.
For more details and registration information please visit
For over a decade, Westgard QC has offered consulting services, training solutions, oem products, and embeddable QC engines to the major diagnostic and laboratory corporations of the world. Some of the world's biggest healthcare companies have used Westgard consulting services for their strategic projects. If you haven't seen what we have to offer, we invite you to take a look:
Consulting: http://www.westgard.com/consulting.html
Training: http://www.westgard.com/training.html
OEM: http://www.westgard.com/oem.html
Embedded QC: http://www.westgard.com/qcengines.html
A COMPARISON OF WESTGARD SOFTWARE
EZ Runs™, EZ Rules™, QC Validator®: Westgard QC has introduced three distinct QC software packages for QC Design and for QC Implementation. How do they match up? What features does each package have? And which one is right for you?
http://www.westgard.com/featuregrid.html
Our complete list of downloads.
EZ Rules™ demos and downloads:
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.You can download standalone demos, view streaming Shockwave movies, and download the foreword, TOC, and section 1 of the program manual at
http://www.westgard.com/ezrules.htm
Basic Method Validation Download:
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)
Online Courses:
Over a thousand 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.
"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.
http://www.westgard.com/levjens.htm
http://www.ascls.org/wqc/lj.htmlBasic QC Practices has hundreds of laboratory professionals enrolled! It's our most popular online course, with dozens of site licences across the country AND AROUND THE WORLD. You get a discount on our Basic QC Practices manual when you sign up! This well-received course has everything that the Multirule and Levey-Jennings Minicourse has and much, much more.
For all the news that was 2004, follow this link. We hope you keep coming back for more.
