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Bah, Humbug: A Modest Proposal concerning EQC
This has been quite a year, full of highs and lows. Perhaps the biggest issue of 2004 for US labs are the "Equivalent" (or perhaps more appropriately, Equivocal) QC Procedures. Ruminating on this confusing new proposal, we make a modest proposal (in the spirit of Jonathon Swift).
CLIA Update: Examining the Scientific Rationale for Equivalent QC
A few months ago, CMS made a statement regarding the scientific justification for the new "Equivalent QC" practices. Most importantly, CMS refers to the NCCLS M2-A8 standard. What does this document state and how does it provide the foundation for EQC?
The Quality of Laboratory Testing: Methodology
There's a wealth of data out there on laboratory testing - particularly the data of proficiency testing programs. Dr. Westgard explains the methodology of turning PT results into laboratory performance metrics.
The Quality of Cholesterol Testing
In the first evaluation of national laboratory performance, we look at the cholesterol testing performance for over 9,500 labs. Find out how well your PT group performs, how well your instrument performs, and how well the country is performing.
The New ISO 15983:2003 Standard
There's a new ISO standard in town - 15189:2003. This one specifically addresses medical laboratories and the requirements for quality and competence. Our guest authors introduce the new standard and compare it to the existing ISO standards
A Scratch and Dent Sale
Over the course of every year, some of our books suffer wear and tear in the warehouse. A scuffed cover, a bent page, small problems that make these less than pristine. The content is still good, but the package is a little worn.So, for a very limited time, we'll be selling these "scratch and dent" copies through our online store (only) for half of list price.
There are only a few of these for each title, so you must act quickly. The offer ends as soon as the supply is exhausted.
http://www.westgard.com/Merchant2/merchant.mv
Finally, the entire Westgard QC staff and family want to extend to you our thanks and good wishes for your holidays.
CLIA Update: The Scientific Rationale for Equivalent QC?
For those wondering about the new "Equivalent QC" procedures, the AACC POC listserve has been a must-read. Arguments about the validity, acceptability, and practicality of "eQC" have been raging back and forth. Recently, someone posted an open letter to CMS, asking for the scientific rationale behind eQC. CMS replied with a statement. For those who don't subscribe to the AACC POC listserve, we're happy to post the entire conversation here.
Quality in the Spotlight: A Nexus in 2005
For ten years, Antwerp has been the site of an amazing conference on Quality in the Lab. (This is also the conference where the annual "Westgard Award" is given.) In 2005, the focus of this conference will be on moving quality to the next level: NEXUS.
Vioxx and Values, Vaccines and Votes
When quality problems at a Chiron plant mean that half our flu vaccine shots are contaminated, you know that Laboratory Medicine has become part of politics.What you may not know is that politics have very much affected Laboratory Medicine in return, and the results of the election may well determine the future of our profession.
Maryland General Hospital Scandal, Part V: A Few Bad Apples, or the Tip of the Iceberg?
After a second Congressional Hearing revealed further problems with the inspection process, the "deemed providers" of accreditation are recalibrating their inspections. Still the question remains: Was the scandal at Maryland General Hospital a case of a "few bad apples" or is just the tip of the iceberg?
http://www.westgard.com/essay68.htm
Remarks at the G2 Conference: "No Lab Left Behind"
On September 30th, Dr. Westgard received the 2004 Leadership Award for Lifetime Achievement from the Washington G2 Lab Institute. You can read his thanks and remarks upon receiving this honor online.
The Quality of Laboratory Testing, Part I
There are a lot of opinions about the state of quality of laboratory testing. FDA, CMS, CAP and many other organizations have put forward the myth that testing is great, with the rare "bad apple" that shows up in the headlines. It's time to see the truth, based on real data, about laboratory performance across the country...
Hundreds visit the Westgard Booth at the 2004 AACC/ASCLS Clinical Lab Exposition!
It was great to see so many people - and place faces to email addresses - in Los Angeles. We were overwhelmed by the crowds and ran out of our giveaways (gold pens) shortly after the show began. Also, the new CLIA book sold out at the AACC bookstore. [This makes it the 5th new Westgard book in a row that sold out at the bookstore during the AACC convention (past sell outs include Basic QC Practices, Basic Method Validation, Basic Planning for Quality, and Six Sigma Quality Design and Control)].
Here are the winners of our annual "Westgard Wear" Raffle:
- Westgard Shirt: Rebecca Ruby Kaamino, Fremont CA
- Westgard Messenger Bag: Tomas Machin, Lompoc District Hospital, Lompoc CA
- Nothing but the Truth: David Delforge, Beckman Coulter, Chaska MN
Finally, you can get the Truth (and Nothing but the Truth)!
At the AACC convention, we proudly announced the publication of our latest book, Nothing but the Truth about Quality. This new book is a critical look on the state of quality in our laboratories. If there is one book that sums up how Dr. Westgard sees quality, this is it, and it's a must read for laboratorians. (and you can download some of the Truth for free.). If you want to know what's going on, what's going wrong, and what we need to move on - the Truth is the book for you.
Maryland General Hospital Scandal, Part IV: Inadequate Inspections
One of the most dramatic revelations of the Maryland General Hospital scandal was the failure of inspections to uncover the problems in the lab. How did the inspections fail, and can new inspection regimes solve this?
Reference Intervals and Reference Values
Per Hyltoft Petersen, our frequent and most welcome contributor from Denmark, reviews the articles of a special CCLM issue on Reference values and Reference intervals.
http://www.westgard.com/guest27.htm
Plus, Dr. Rustad describes the efforts to establish reference intervals across not only the Nordic countries, but also across analytic methods.
Come Visit us at the AACC/ASCLS Clinical Lab Exposition!
Westgard QC will be at booth #426 in Los Angeles, July 27-29. Please drop by to take part in our annual "Westgard Wear" Raffle, browse through our new CLIA book (and any other Westgard book), watch a demonstration of our latest QC software, and more (see below...).We'd love to see you and hear what you're doing about QC.
Hearings on Untruth, Part II: Facts of the Maryland General Hospital Scandal
For those of you who haven't been able to follow the scandal at Maryland General Hospital, here's a recap of the laboratory deficiencies, errors, and catastrophes - plus details on the congressional hearings on this issue.
http://www.westgard.com/essay64.htm
Hearings on Untruth, Part III: Broken Windows at Maryland General
There are two questions that all laboratory professionals are asking about the scandal at Maryland General Hospital: How could it get this bad? and How could it take so long to discover the problems? Dr. Westgard and Sten Westgard try to answer those questions, and pose an even more important question.
http://www.westgard.com/essay65.htm
Connecting the Dots
As laboratory scientists, we're taught to connect the dots between control points to look for patterns in the data and underlying causes. As observers of world events, we can also connect the dots and study the patterns to understand the underlying causes. Those events can help us understand the importance of quality control practices in the laboratory.
http://www.westgard.com/essay66.htm
Preview the Truth!!
At the AACC/ASCLS convention, Dr. Westgard will release a new book, Nothing but the Truth about Quality, a critical new treatise on the state of quality in our laboratories. If you can't attend the convention, you can preview the book here for free.
http://www.westgard.com/truthbook.html
CLIA manual now available!
Westgard QC is proud to announce the publication of the
CLIA Final Rules for Quality Systems manual:
Quality Assessment Issues and Answers
2004, 225 pages
http://www.westgard.com/cliabook.htm
Dr. Sharon S. Ehrmeyer, PhD, MT(ASCP), Dr. Teresa Darcy, MD, FACP, and Dr. Westgard have written a new book that explains the practical impact of the final CLIA regulations and interpretive guidelines. All the key changes are covered, and extra analysis is provided of the new laboratory responsibilities that the regulations have created.
If your job involves CLIA, this is a critical reference. http://www.westgard.com/cliabook.htm
Hear, Hear! Hearings on Untruth and Unquality
Dr. Westgard comments on the recent reports involving Maryland General Hospital and an excessive number of laboratory testing errors. Quality has gotten so bad in this one lab that Congress is holding hearings. Is this the first step toward CLIA 2005? Westgard Web presents the first in a series of articles on this developing story.
http://www.westgard.com/essay63.htm
ISO-2: ISO 9001:2000 and Quality Management Systems
Our guest authors Rogério Rabelo M.D., Ph.D. and Daniel Marques Périgo R.Ph. and continue their discussion of ISO and Quality Management Systems. In this second article, the authors discuss the eight basic principles of good quality management.
http://www.westgard.com/iso2.htm
Is the CLIA Final Rule the Final Word on Quality?
On April 28, 2004, the AACC held its audioconference on “CLIA’88: Recent Changes, Future Directions.” During that conference, the speakers were asked to respond to "our" position on "equivalent QC procedures." To respond to those responses, we want to clarify our concerns about Eqc.
http://www.westgard.com/essay62.htm
From Precision Claims to Six Sigma estimates: High Volume Hematology Analyzers
Last month we provided information on how to convert Precision claims into Six Sigma metrics. This month we put the lesson into practice. Working with CAP Today's recent survey of High Volume Hematology Analyzers, we convert the manufacturer precision claims into Six Sigma estimates. Want to see how the instruments shape up?
http://www.westgard.com/qcapp27.htm
From Method Validation to Six Sigma metrics: POC glucose
We recently came across a paper comparing 4 POC blood glucose monitoring instruments. Here's a good picture of the performance of POC devices. Do you think POC devices achieve the same quality as those methods in the central lab? See how they stack up.
http://www.westgard.com/qcapp28.htm
2004 Biological Variation Database Update
Dr. Ricos et al. have updated their incredibly valuable database of biological variation and desirable specifications for imprecision, bias, and total error. We are happy to present these specifications with permission from the authors.
http://www.westgard.com/guest26.htm
Testing Equivalent Quality: A better way
CMS has created "equivalent QC", but the regulations really only allow "equivalent quality testing." This difference is important - and if "Eqc" is here to stay, finding the equivalent quality in testing is the only way to find a real solution. Finding that quality can be done, and done simply, using Sigma Metrics.
From Precision Claims to Six Sigma metrics
When you buy a new diagnostic device, the manufacturer is required to provide you with performance claims. How useful are those claims? If we convert them into Sigma metrics, can we get even more information? See how claims can become metrics, and what the results will mean.
A CLIA Final Rule recap
For more than a year, Westgard Web has covered the CLIA Final Rule, the Interpretive Guidelines, and the "equivalent QC practices". Here's a recap of all the articles presented.
- I: Key Changes in the CLIA Final Rule http://www.westgard.com/essay50.htm
- II: Perplexity about Personnel and Complexity, by Sharon S. Ehrmeyer, Ph.D. http://www.westgard.com/cliafinalrule2.htm
- III: Conflict between Quality vs. Compliance in QC. http://www.westgard.com/cliafinalrule3.htm
- IV: New Regulations for Method Validation, by Sharon S. Ehrmeyer, Ph.D. http://www.westgard.com/cliafinalrule4.htm
- V: Method Validation Process and Procedures http://www.westgard.com/cliafinalrule5.htm
- VI: Statistical Sense, Sensitivity, and Significance http://www.westgard.com/cliafinalrule6.htm
- VII: "Equivalent QC Procedures" http://www.westgard.com/cliafinalrule7.htm
- VIII: The Interpretive Guidelines http://www.westgard.com/cliafinalrule8.htm
- IX: Appropriate QC Procedures http://www.westgard.com/cliafinalrule9.htm
- X: Lies, Damn Lies, and "Equivalent QC" http://www.westgard.com/cliafinalrule10.htm
- More on CLIA and "Quality-Less" Compliance http://www.westgard.com/essay60.htm
We hope these reports and essays have been useful to you. In the coming months, we hope to expand the coverage to address even more of the issues you find important. We invite you to share your thoughts on the CLIA Final Rule, and if you have other topics you'd like us to cover we invite your suggestions.
Westgard in the News
Westgard Web isn't been the only source of news on CLIA, but other journals are starting to come here before they write their stories:
- January 2004, AACC Strategies Newsletter, "CLIA Guidelines Provide New Options for POC Blood Gas, Coagulation QC" - interview with Dr. Westgard for comments
- February 2004, AACC Clinical Lab News, "CLIA Interpretive Guidelines Debut on CMS Website" by Sue Auxter-Parham - extended interview with Dr. Westgard for comments
- March 2004, AACC Clinical Lab News, "Imprecision and Physiological Variation", by Dr. David G. Grenache, PhD. Referenced in this article is the guest essay by Dr. Callum Fraser on "Are 'Scientific Statements' the scientific truth?" http://www.westgard.com/guest23.htm
The full article is at http://www.aacc.org/cln/series/phy_variation.pdf
If you've seen a Westgard Web article referenced, posted, circulated, or cursed, we'd love to hear about it.
Lies, Damn Lies, and "Equivalent QC"
When the CLIA Final Rule Interpretive Guidelines came out, a new practice called "Equivalent" QC was introduced. Just what is it equivalent to? Well, if it was applied to fire safety, CMS would be telling you to turn off your smoke detectors.
More on CLIA Final Rule and "Quality-Less" Compliance
We've covered the specifics of the CLIA Final Rule and the Interpretive Guidelines, but now it's time to take a look at the Big Picture.
- Why did it take over ten years to get the CLIA Final Rule?
- Why did manufacturer's QC clearance go by the wayside?
- Why did we end up with "electronic QC" and "equivalent QC"?
- Where did the need for better quality for the patient go?
The Gospel According to ISO
The International Standards Organization (ISO) is having a growing impact on industry and labs in the US, and it has become common outside the US for laboratories to seek ISO certification. Dr. Westgard introduces a new series of articles examining ISO and its relevance to the laboratory.
ISO-1: Basics and Perspectives
Daniel Marques Périgo R.Ph. and Rogério Rabelo M.D., Ph.D., veterans of ISO certification, explain the concepts of the International Standards Organization. Learn what you can expect (and not expect) if and when your organization embraces ISO.
Think Straight, Talk Straight
Enron is in the news again, and Dr. Westgard has been studying their failings - and the ethics that they really practiced. What he finds is that _our_ compliance mentality bears a considerable resemblance to the Enron accounting mentality. Really.
CLIA Final Rule: The Interpretive Guidelines
On January 12, 2004, CMS released Appendix C of the State Operations Manual. That happens to be the Interpretive Guidelines for the CLIA Final Rule. And what is contained in those interpretations are some major changes in how laboratories will be regulated, and what kind of QC they will be allowed or required to perform. Get the first look at the true impact of these guidelines with the help of Dr. Sharon Ehrmeyer, Ph.D. and Dr. Westgard
Autoverification: Taking QC to the next level?
Autoverification seems to be a hot topic these days. Articles are in the press, the journals, and soon to come audioconferences. But just what is autoverification, and how does it relate to QC? And if it doesn't involve QC, just what is really being verified?
Where in the World will Westgard Be - in 2004?
Dr. Westgard has justed added a Six Sigma workshop to be held in Denmark on March 22nd, 2004, hosted by Radiometer. To learn more about this workshop and other upcoming appearances around the world by Dr. Westgard, visit the link below - and also check out the Westgard Workshops 2004
CLIA Final Rule: Appropriate QC Procedures
If we realize that "equivalent" qc procedures are not equal... If we want to assure quality rather than comply with regulations... If we want to do the right QC, not the least QC... What is the appropriate QC to do? And how do we determine it?
CLIA Final Rule for Quality Systems - Interpretive Guidelines and Inspection Issues
June 14, 2004 * 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:
- Judy Yost, MA, MT(ASCP) of CMS
- 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 15-16, 2004 * 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
EZ RUNS™ AND INSTRUMENT MANAGER™
How can you import data directly into the world's most advanced QC program from hundreds of instruments? With the powerful combination of Instrument Manager™ and EZ Runs™.
http://www.westgard.com/ezrunsandim.html
EZ Runs™ demos and downloads:
EZ Runs™ software is the most advanced QC Charting software in the world. It offers you Levey-Jennings charts with the best "Westgard Rules" from the largest, most optimized control rule library. MultiChart™ view lets you see multiple controls, materials and levels all on one intuitive screen. Real-time decision-making occurs as control data is automatically interpreted, errors are automatically flagged, and corrective actions are automatically recorded in to an Action Log. EZ Runs™ also allows you to perform Mult-Stage QC, the most advanced type of QC Design for the hardest-to-QC tests. All of this, with complete custom control over reporting and an EZ interview process that asks you a few simple questions one step at a time. For both the expert and the novice in QC, there is only one choice for QC Charting. (And for a limited time, integrated EZ Rules™ is included free with purchase)You can download standalone demos, view streaming Shockwave movies, and download the foreword, TOC, and section 1 of the program manual, or just find out more at
http://www.westgard.com/ezruns.html
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 2002,
follow this link. We put up so many 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.
