The Westgard Web Essays James O. Westgard, PhD This page contains a list of all the essays (120+) written for Westgard Web by Dr. Westgard. You can access every public essay by clicking the green button. To access a preview of an essay, click the blue preview button.

All the words of Westgard

Read!	Essay Title	Preview	Availability	Get the books:
	2008: The year of EQC, AQC, or no QC at all?		Public	Assuring the Right Quality Right Six Sigma, 2nd Edition! EZ Rules© 3 CLIA Final Rules Nothing but the Truth Basic Method Validation, SECOND EDITION! Basic QC Practices Manual SECOND EDITION!! Basic Planning for Quality manual
	The Quality of Glycated Hemoglobin (Ghb)		Public
	Equivocal QC: Coming to a Lab near you		Public
	A War of Words in Laboratory Terminology, Part III		Public
	A War of Words in Laboratory Terminology, Part II		Public
	A War of Words in Laboratory Terminology?		Public
	"But...is it really out?"		Public
	Errors In, Before, Behind the Laboratory?		Public
	The Health of US Healthcare		Public
	CLSI faces the Challenge of Quality		Public
	The Meaning and Application of Total Error		Public
	Spotting Quality Internationally: Antwerp Meetings		Public
	Truthful Guidance about Trueness		Public
	Truthful Claims may not be enough		Public
	In 2007, Method Validation Skills are Still Vital		Public
	Global and Local Imperatives in US Healthcare		Public
	Why We Write.		Public
	2006: Links to South Africa		Public
	GLP for Lab QC: Part II		Public
	GLP for Lab QC: Part I		Public
	2006: Links to Spain		Public
	2006: Links to Argentina		Public
	Thank you...		Public
	Rumors of my Retirement are somewhat exaggerated...		Public
	GAO Report: the agencies respond		Public
	GAO Report on Recommendations: good, bad, and irrelevant		Public
	GAO Report on CMS - it's out		Public
	Update on Quality Design Tools		Public
	What's the Laboratory's Core Competency?		Public
	Open Letter to CLSI		Public
	Trouble with Tracking Tests		Public
	Quality Indicators and Benchmarks		Public
	Hopeful Healthcare in a Fearful Society		Public
	Unannounced Inspections: Unlikely to improve quality		Public
	100,000 miles to Quality: 2005 in Review		Public
	QC: Not just a technicality		Public
	Links to India, Part II		Public
	Method Performance and Test Quality: Same thing?		Public
	Links to India, Part I		Public
	The Quality of PT Sigma Metrics		Public
	The Quality of Coagulation Testing		Public
	Solutions for a Taxing Problem		Public
	The Quality of PSA Testing		Public
	The Quality of Glycohemoglobin Testing		Public
	The Quality of Calcium Testing		Public
	The Quality of Glucose Testing		Public
	Bah, Humbug! A look back at 2004 and EQC		Public
	The Quality of Cholesterol Testing		Public
	The Quality of Laboratory Testing, Part II: Methodology		Public
	Vioxx and Values, Vaccines and Votes		Public
	Remarks at the G2 Conference: "No Lab Left Behind"		Public
	The Quality of Laboratory Testing, Part I		Public
	Maryland General, Part V: Tip of the Iceberg?		Public
	Maryland General, Part IV: Inadequate Inspections		Public
	Connecting the Dots		Public
	Maryland General, Part III: Broken Windows at Maryland General Hospital		Public
	Maryland General, Part II: Facts of the Maryland General Healthcare Scandal		Public
	Maryland General, Part I: Cracks in the Healthcare System?		Public
	Is the CLIA Final Rule the Final Word?		Public
	Testing Equivalent Quality: A Better Way		Public, Truth
	More on CLIA and "Quality-Less Compliance"		Public, Truth
	Quality Management - the gospel according to ISO		Public
	Think straight, Talk straight		Public, Truth
	Autoverification: Taking QC to the next level - is that up or down?		Public, Truth
	Giving Thanks for 2003: Some observations on the state of QC		Public
	Medical Errors: Complexity and its solution		Public, Truth
	ISO Says So: NCCLS recommendations for Validation of User QC		Public, Truth
	2004 JCAHO Patient Safety Goals - What our goals say about where we are now		Public. Truth
	It's an Honor - personal reflections on being a teacher		Public, Truth
	"The truth, the whole truth, and nothing but the truth" - A Demanding Standard for Quality		Public, Truth
	The Final5 CLIA Rule 1/24/03		Public
	Good Data Wanted - Bad Data Need Not Apply		Public, Truth
	Signs of Six Sigma		Public
	A Momentous Happening - A New Way to Do QC!		Public
	Cooking the Books - Does it happen in the laboratory?		Public, Truth
	Quality: "I think I got it!"		Public
	Why not evidence-based method specifications?		Public, Truth
	Has quality been "Enronned"?		Public, Truth
	$aving the Cost$ of Poor Quality (Six Sigma)		Public
	Technology for implementing QC Right		Public
	Six Sigma Staffing Strategies		Public
	Repeated, repeated, got lucky!		Public, Truth
	CLIA postponed again and again and again		Public, Truth
	2001: Year of the Odyssey		Public, Truth
	Six Sigma and Requisite Laboratory QC		Public
	Six Sigma Quality Managment		Public
	Errors in Reasoning about Laboratory Errors		Public, Truth
	Quality is Job 1 when the Rubber meets the Road		Public, Truth
	Who will care for quality tomorrow?		Public
	EZ Rules for Quality Assurance		Public
	Sage Advice on "New Approaches to Quality Control"		Public, Truth
	WQC Y2K: Plans, Predictions and Predicaments		Public
	The Abbott-FDA Consent Decree? A Wake-Up Call for Laboratories		Public
	The Do's and Don'ts of Quality Control		Public
	Education and Training for Analytical Quality Management, Part IV: Internet tools for Training		Public
	Quality Control 2000: What changes are needed?		Public
	To be Uncertain or in Error? That is the question		Public, Truth
	What's wrong with traditional Quality Control?		Public
	The Need for a System of Quality Requirements		Public
	Z-Stats: Those #$%@&! Statistics		Public
	Quality Requirements: The Debate Heats up!		Public
	Points of Care for Statistics in Method-Comparison Studies		Public
	Beijing abstract: QC Principles, Practices, and Planning		Public
	From Rules and Tools to Technology and Training		Public
	Electronic QC and the Total Testing Process		Public, Truth
	Education and Training for Analytical Quality Management, Part III: Basic QC Training		Public
	Principles of QC Planning for Immunoassays		Public, BMV
	Method Validation: The Inner, Hidden, Deeper, Secret Meaning		Public, BMV
	Education and Training for Analytical Quality Management, Part II: Developing Internet courses		Public
	Quality and Commerce		Public
	QC - "Back to Basics"		Public, BQC
	Mapping the Road to Quality with OPSpecs Charts		Public
	Education and Training for Analytical Quality Management, Part I: Developing a "Lesson-Base"		Public
	Tools and Technology for QC Planning		Public
	Quality by Design		Public, Truth
	The Myth of Medical Decision Limits		Public
	Future Directions in Quality Control		Public
	Quality Goals, Requirements, and Specifications		Public
	Trends in Quality management: Utilization and Outcomes		Public
	Assuring Quality through Total Quality Management (TQM)		Public
	Putting Quality into Quality Control		Public
	Myths of Quality		Public, BMV

The Myths of Quality

We like to assume that everything works perfectly in today's healthcare laboratory; that analytical quality is a given; that even if we don't know what quality we need to achieve, we're achieving it; that today's methods have better imprecision and inaccuracy than needed; that no further improvements are necessary in the QC of the 21st century. Dr. Westgard discusses these myths, sorting fact from fiction, and providing commentaries. Read this essay Back to Top

Putting Quality into Quality Control

Many laboratories and manufacturers say that they "do" quality control - but can't explain what level of quality they're acheiving. The term "Quality Control" is much-abused. In many cases, Dr. Westgard explains that what laboratories are actually performing is arbitrary control, not quality control. How do we put the quality back into quality control? Reading this essay is a good start. Read this essay Back to Top

Assuring Quality through Total Quality Management (TQM)

The teachings of industrial quality gurus, such as Deming and Juran, established new principles and processes for managing quality. Deming provided the principles for what needs to be done and Juran described the methodologies or processes for getting it done. See how a combination of these two - Total Quality Management (TQM) - can be applied to the healthcare laboratory field. Read this essay Back to Top

Trends in Quality management: Utilization and Outcomes

Re-engineering, out-sourcing, down-sizing, outcomes focus -- all the management fads have come to the healthcare laboratory with a vengeance. Dr. Westgard (with a little help from Dilbert) sorts out which approaches are valid and which are dangerous. Read this essay Back to Top

Quality Goals, Requirements, and Specifications

Everyone agrees that there should be quality control. But what does that mean? When we implement new methods in our laboratories, or develop new methods, or try to establish regulatory guidelines for performance of methods, or even inspect laboratories to assure that good quality management practices have been implemented, how do we specify bias, CV, the number of controls, the levels, etc.? Dr. Westgard introduces a way to sort it all out. Read this essay Back to Top

Future directions in Quality Control

Total Laboratory Automation and POC devices are two trends in current diagnostic equipment. Dr. Westgard reviews the history of quality control, from manual methodsin the 1950s, to the current state of the art of laboratory fourth generation instrumentation, to the quality control systems in future instruments. Learn how automation and computerization will impact the future quality control practices - what will be done for us, and what we still have to do for ourselves. Read this essay Back to Top

The Myth of Medical Decision Limits

Medical Decision Limits are described as a "second set of limits set for control values ...meant to be a wider set of limits indicating the range of medically acceptable results." The idea is that these medical decision limits embody the medical usefulness requirement for a test and by drawing these limits on our control charts, we will detect medically significant errors. Using CLIA QC requirements and practical examples, Dr. Westgard evaluates these MDLs and reveals their true nature. Read this essay Back to Top

Quality by Design

An updated version of this essay appears on the Nothing but the Truth about Quality book. If we're honest with ourselves, we know that the situation in the laboratory needs to be improved. But with all the time pressures, staff shortages, and other stresses, how can we find a quick way to put the quality back into quality control? How do we select methods that can guarantee error detection? Create purchase specifications to select instruments that can guarantee we meet our CLIA requirements? Design instruments with quality in mind? Dr. Westgard suggests practical steps that both users and manufacturers can take to bring quality into their design. Read this essay Back to Top

Tools and Technology for QC Planning

Just as instruments have evolved from manual pipettes to vast automated instruments, so too has the technology for quality control. When we're using a fourth generation instrument, should be be doing first generation quality control (like the old standby, 1:2s), a practice that was introduced in the 1950's? Dr. Westgard charts the history and progress of QC technology and introduces new tools (QC Selection grids, OPSpecs charts, automated QC selection) that we can use for the 21st century. Read this essay Back to Top

Education and Training in Analytical Quality Management, Part I: Developing a Lesson-Base

The Digital Age has revolutionized countless facets of our society. Dr. Westgard discusses how the Internet it has and will impact our industry: how we can now access education and training over the web at anytime, from anywhere in the world. (If you can read this, you're part of the revolution!). Read this essay to see how workshops, courses, seminars and more will be affected by electronic communication. Read this essay Back to Top

Mapping the Road to Analytical Quality with Charts of Operating Specifications

Quality is often described as a journey. Too often our efforts describe where we've been and how we arrived at the present, rather than advancing to where we need to be in the future. Laboratory efforts need to advance quality with well-defined destinations, maps to guide us to those destinations, and careful planning to provide a smooth journey. The way is revealed. Read this essay Back to Top

QC - "Back to Basics"

Dr. Westgard explains the bare minimum everyone needs to know, and goes on to detail what laboratory technicians, medical technologists, clinical laboratory scientists, clinical chemists, QC specialists, supervisors, managers, and even directors need to know about quality control in their laboratory. If you see your title on this list, check out the essay and find out if you know all you should know. Read this essay Back to Top

Quality and Commerce

A discussion of Westgard QC and its new offerings - more online courses, more downloads, more information, and the ability to order our products directly through the website. How do we balance our educational offerings with our commercial ones? Dr. Westgard talks about this delicate juggling act and invites your comments. Read this essay Back to Top

Education and Training in Analytical Quality Management, Part II: Developing Internet courses

You may not know this (we hope you do), but Westgard QC offers several online courses for education and training. How do we do this? Here's a behind-the-scenes discussion of how we develop "just-in-time" courses for college courses, workshops, seminars, and continuing education courses for clinical chemists and clinical laboratory scientists. Read this essay Back to Top

Method Validation: The Inner, Hidden, Deeper, Secret Meaning

We run controls, we collect data, we create graphs and charts and plots and crunch numbers. Then we stuff it all in a folder and hand it to an inspector. It's called method validation. But what is it? How do we do it? Why do we do it? Dr. Westgard reveals the secret meaning behind it all. Read this essay Back to Top

Principles of QC Planning for Immunoassays

Dr. Westgard takes the theory and tools of quality planning and applies it to immunoassays. This was part of his presentation to the joint meeting of UK National External Quality Assessment Schemes (UK NEQAS) for Endocrinology and the European Ligand Assay Society (ELAS) in Edinburgh, Scotland, a paper that he delivered "virtually" to the conference. Read this essay Back to Top

Education and Training for Analytical Quality Management, Part III: Basic QC Practices training

Over the years, the practice of quality control has been corrupted (all those repeat runs, widening control limits, and even worse). It's time to get back to the basics. To that end, using all the technology of the late 20th and early 21st century, Dr. Westgard introduces a Basic QC Practices training course available online, on CD, and in one of those "old-fashioned" books. (If you ask nicely, he'll probably do it in person at your next conference, too.) Read this essay Back to Top

Electronic QC and the Total Testing Process

An updated version of this essay appears on the Nothing but the Truth about Quality book. POC devices are all the rage. But they don't do normal QC, they do "electronic QC". Just what is "electronic QC"? What does it really measure? And is it ever going to replace the real thing? Dr. Westgard provides a lucid hype-free discussion. Read this essay Back to Top

From Rules and Tools to Technology and Training

At the Fourth European Conference Quality [r]evolution in Clinical Laboratories, in Antwerp, Belgium, Dr. Westgard charted the course of the recent developments in quality control. He covers the introduction of the original multirule ("Westgard Rules") to the introduction of the OPSpecs chart, to software-automated QC selection, to the future applications of embedded software in instrumentation and laboratory information systems. Read this essay Back to Top

QC Principles, Practices and Planning

An excerpt from Dr. Westgard's address to the Conference on Quality Control of Clinical Chemistry Organized by the National Center for Clinical Laboratories, in Beijing, China. See how natural variation in test data gives rise to statistical monitoring, how statistical monitoring gives rise to multirule control (aka "Westgard Rules"), and how multirule control gives rise to operating specifications, quality planning, and practical tools. Read this essay Back to Top

Points of care in using statistics in Method-Comparison Studies

A top 10 list of things you should know about method validation. If you're not sure you're using the right statistics, the right regression, or the right plots and graphs, read here. Read this essay Back to Top

Quality Requirements: The Debate heats up!

After years of neglect, people are beginning to get interested in the issue of what quality requirements are, where they come from, and which ones must be met by today's laboratory. Dr. Westgard gives an introduction to some of the issues and suggests a system of quality requirements is needed to accomodate different approaches and applications. Read this essay Back to Top

Z-stats: Those #$%@! statistics

There are lies, damn lies, and statistics. Why do we fear and distrust statistics? Dr. Westgard ponders the subject and suggests that the reason QC in the laboratory is suffering may be because of our attitudes. Luckily, there's a remedy... Read this essay Back to Top

The Need for a System of Quality Standards

We've got TEa, performance criteria, clinical outcome criteria, proficiency testing criteria, total biologic goals, and, of course, "state of the art." It's no wonder people are confused about quality requirements. Find out how CLIA, NCEP, biological goals, clinical decision intervals, and other quality standards can (and should) be reconciled. Read this essay Back to Top

What's wrong with traditional quality control?

Dr. Westgard addresses the Frequently-Made-Complaints (FMC's) about statistical quality control. Over the years, a whole host of gripes have accumulated. Learn which of them are valid criticisms and which of them are just plain whining. Read this essay Back to Top

To be uncertain or in error? That is the question

An updated version of this essay appears on the Nothing but the Truth about Quality book. Do you know the new ISO terms? Dr. Westgard weighs in on the new terminology and suggests there are practical applications for the new uncertainty concepts as well as the old error concepts. He also asks, should we be spending time improving terminology or improving lab performance? Read this essay Back to Top

Quality Control 2000: What changes are needed?

Forget about Y2K - what about Y2QC? What's going to happen to quality control in the laboratory? Are we going to give it up entirely? Will there be any people left in the automated laboratory? Dr. Westgard attempts to predict and recommend changes for this new millenium. Read this essay Back to Top

Education and Training in Analytical Quality Management, Part IV: Internet Tools for Training

You've built a "lesson-base." You've created an online course. You've addressed the need to teach basic skills. Now what's missing? Of course: interactive tools for the Internet. Plotters, calculators and data simulation tools that allow the user to plug in numbers on the fly and see what happens. See the new tools and what you can do with them. Read this essay Back to Top

The Do's and Don'ts of Quality Control

Dr. Westgard makes it simple and gives a primer on how to avoid excessive repeat runs, inspection failures, and maybe even larger problems. Read this essay Back to Top

The Abbott-FDA Consent Decree: A Wake-Up Call for Laboratories

A $100,000,000 fine? What's up? The recent Abbott-FDA Consent Decree resulted in a such a hugh penalty 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. Read this essay Back to Top

WQC Y2K: Plans, Priorities and Predicaments

The new millenium 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. 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. Read this essay Back to Top

Sage Advice on "New Approaches to Quality Control"

An updated version of this essay appears on the Nothing but the Truth about Quality book. Dr. Westgard recently attended an AACC meeting on "New Approaches to Quality Control." Statistical QC was implemented in industry in the 1930's and in the healthcare field in the 1960's. It's still faithfully used in industry today, but for some reason a lot of people in healthcare want to give up on it. Dr. Westgard summarizes the "new" thinking and examines some of the underlying reasoning. Read this essay Back to Top

EZ Rules for Quality Assurance

Dr. Westgard gives a sneak preview of our newest software. EZ Rules is a simple interview format program that makes it simple, easy, fast, and automatic to plan quality. Read this essay Back to Top

Who will care for quality tomorrow?

There is a crisis in laboratory staffing; the demand for laboratory professionals has exceeded the supply by thousands. Yet fewer and fewer students are pursuing medical technology. Dr. Westgard examines why this is, what impact it will have on the laboratory, and what solutions will be devised to deal with the scarcity of staffing. Read this essay Back to Top

Quality is Job 1 when the Rubber meets the Road

An updated version of this essay appears on the Nothing but the Truth about Quality book. Yes, it's a mixed metaphor. It's also an essay on the Ford/Firestone debacle, and what it means to us in healthcare laboratories. First we saw the $100 million fine on Abbott, now the recall of millions of defective tires. When will we realize that higher management has a problem with quality? Read this essay Back to Top

Errors in Reasoning about Laboratory Errors

An updated version of this essay appears on the Nothing but the Truth about Quality book. What's scarier? The fact that there are errors in laboratories, or the fact that we don't understand what those errors mean? A lot of logically dubious arguments have been put forward about reducing QC, ignoring QC, or eliminating the practice of QC altogether. Dr. Westgard examines and refutes the thinking behind these arguments. Read this essay Back to Top

Six Sigma Quality Management

Have you heard about Six-Sigma yet? It's the latest trend in quality management. It has revolutionized business processes in companies like GE and Motorola. The famed Jack Welch of GE even made it a mandatory requirement that all executives learn and practice Six Sigma. Dr. Westgard explains what's new about this approach, what's hype, and what can be applied in the laboratory. Read this essay Back to Top

Six Sigma and Requisite Laboratory QC

In the healthcare market, a lot of manufacturers are issuing products with more of an eye on their profit margin than on the quality of the product. If your manufacturer can't meet Six Sigma requirements, what can you do? Improve your internal laboratory QC -- Dr. Westgard explains how. Read this essay Back to Top

2001: Year of the Odyssey

An updated version of this essay appears on the Nothing but the Truth about Quality book. This isn't the first nor probably the last article to compare this year to the landmark film 2001: A Space Odyssey. Over 32 years ago, Stanley Kubrick and Arthur C. Clarke predicted a world of routine space travel, giant computers, and vast possibility. Has our 2001 met these expectations -- in the laboratory? Dr.Westgard muses on what laboratory professionals thought back in 1968 and how things have "changed" since then. Read this essay Back to Top

CLIA postponed again and again and again

An updated version of this essay appears on the Nothing but the Truth about Quality book. For the third time in a row, the CLIA manufacturer clearance requirements for QC clearance have been postponed. What's taking so long? Why can't HCFA and DHSS come to a conclusion? Are the manufacturers exercising some undue influence? Better than answering these questions, Dr. Westgard suggests that we shouldn't wait for more CLIA rules. We have enough rules to go on right now - and here's how to use them to improve QC... Read this essay Back to Top

Repeated, repeated, got lucky!

An updated version of this essay appears on the Nothing but the Truth about Quality book. Believe it or not, but this is an actual comment from an QC action log (from a facility that shall remain nameless). At least the author was being honest about how he/she was performing their QC - by luck, not by science. If you still use 2s limits for your controls, you need to read this article. If you still repeat controls and runs until they're "in," you need to read this article. And for anyone who thinks that QC is just fine, you really, really need to read this article. Read this essay Back to Top

Six Sigma Staffing Strategies

Six Sigma not only tells you where you can cut costs and improve quality, it's also a great staffing indicator. See how Sigma-metrics can tell you where staff rotation is possible, and where you need to put your best techs. Read this essay Back to Top

Technology for Implementing QC Right

What kind of software is available for Quality Control? Is the software you get for "free" up to the job? Dr. Westgard provides a cogent survey of what's available in today's market. He also highlights what features are important in a QC program, as well as the features that still need to be offered. Read this essay Back to Top

$aving the Cost$ of Poor Quality

Contrary to popular business belief, there are ways to improve quality and save money at the same time. Six Sigma is founded on that core philosophy. But where are the savings in the laboratory? Here's a hard fact: poor QC practices are wasting money in your laboratory RIGHT NOW. Dr. Westgard shows how to identify, quantify, and eliminate the wasted time, effort, and resources spent on repeat runs, repeated controls, and poor patient care. Six Sigma Cost Worksheets are included and can be downloaded. Read this essay Back to Top

Has Quality been "Enronned"?

An updated version of this essay appears on the Nothing but the Truth about Quality book. As we watch the unfolding Enron scandal, it's tempting to believe that those terrible practices could never happen in healthcare. Alas, Dr. Westgard has examined the facts of the Enron case and seen the hidden face of our healthcare industry. We have much of Enron in our laboratories, our institutions, our regulators, our control and diagnostics manufacturers, even in our professional standards. Read this essay to see what we can learn -- and unlearn -- from the Enron scandal. Read this essay Back to Top

Why not Evidence-based Method Specifications?

An updated version of this essay appears on the Nothing but the Truth about Quality book. In the March issue of Clin Chem, the NACB published a long paper about the use of laboratory tests for patients with diabetes. Dr. Westgard examines their "evidence-based" recommendations, and finds some poor Sigma values. See also the related QC applications: Choosing QC for Glycated Hemoglobin and Setting Specifications for Gylcated Hemoglobin Read this essay Back to Top

Quality: "I think I got it!"

That was the oft-heard refrain at Westgard Workshops 2002. For those of you who weren't able to attend the workshops, this has pictures of what we did, quotes from those who came, and some observations from Dr. Westgard on why these workshops are so important and so successful. Read this essay Back to Top

Cooking the books - does it happen in the laboratory?

An updated version of this essay appears on the Nothing but the Truth about Quality book. Enron, Arthur Andersen,Worldcom, the list goes on and on. Corporate scandals have swept the nation. Executives have been cooking the books and playing with the numbers. Are we in the laboratory immune? Or have we been playing with our numbers, too? Dr. Westgard examines some of the current laboratory practices, including guidelines recently published, to see if the numbers add up. Read this essay Back to Top

A Momentous Happening - A New Way to Do QC!

A new QC technology has been cleared that replaces the use of traditional external quality controls. This happened because a manufacturer submited a claim for this new QC technology and provided the documentation to defend that claim. Read all about it! Read this essay Back to Top

Signs of Six Sigma

A few years ago, Dr. Westgard was one of the first and only voices advocating the application of Six Sigma to healthcare processes. Times have changed. Six Sigma is starting to pop up everywhere. See where it's showing up today. Read this essay Back to Top

Good Data Wanted - Bad Data Need Not Apply

An updated version of this essay appears on the Nothing but the Truth about Quality book. The premier scientific journals have announced a new initiative called STARD (Standards for Reporting Diagnostic Accuracy) What does STARD mean for you? And what does it say about the data being reported in journals today? Dr. Westgard investigates. Read this essay Back to Top

The Final5 CLIA Rule: 1/24/03

The final, final, final, final, final CLIA Rule was published on January 24, 2003. After 15 years, CLIA-88 is finally final. The last rules contain some big changes in terminology, organization, and regulation. It promises to have a huge impact on the "compliance" minimums for QC, on the responsibility for QC in the laboratory, and on the requirements made on manufacturers to provide quality instruments and methods. Read this essay, first of a series, for in-depth and comprehensive coverage of these new rules. Read this essay Back to Top

The Truth, the Whole Truth, and Nothing But the Truth - A Demanding Standard for Quality

An updated version of this essay appears on the Nothing but the Truth about Quality book. As we look at the quality of laboratory medicine, we need a demanding standard for judging the truth. See how some new tests (hs-CRP) and new recommendations (diabetes) fare when they're held up to the "the truth, the whole truth, and nothing but the truth" standard. Read this essay Back to Top

It's an Honor - personal reflections on being a teacher

An updated version of this essay appears on the Nothing but the Truth about Quality book. Dr. Westgard was given the 2003 Professor Alvin Dubin award for Distinguished Contributions to the Discipline and Practice of Clinical Biochemistry. The National Academy of Clinical Biochemistry presented the award to Dr. Westgard during the AACC meeting in Philadelphia. This occasion gave Dr. Westgard the opportunity to thank those who helped shape his career. Read this essay Back to Top

2004 JCAHO Patient Safety Goals - What our goals say about where we are now

An updated version of this essay appears on the Nothing but the Truth about Quality book. JCAHO just released its goals for patient safety. How we define our goals says a lot about what we're doing - or not doing - right now. See what next year's goals say about current patient safety. Read this essay Back to Top

ISO Says So - Recommendations for Validation of User QC

An updated version of this essay appears on the Nothing but the Truth about Quality book. The NCCLS came out with a recommendation on Validation of User QC for ISO. Dr. Westgard reviews these recommendations, and examines the ISO system as a whole. Read this essay Back to Top

Medical Errors: Complexity and its solutions

An updated version of this essay appears on the Nothing but the Truth about Quality book. Recently, a JAMA study revealed that medical errors cost the US at least $9 billion in extra charges and treatment, and kill over 32,000 people, every year. Recently, a Misys software flaw was discovered, work-around-ed, and patched. Recently, everyone has been talking about getting their processes "Lean." What's the unifying thread here? Complexity and its many solutions: automation, computerization, and simplification. Examine the stories of the day and understand the source of today's problems - and maybe even understand where problems will occur in the future. . Read this essay Back to Top

Giving Thanks for 2003 - some observations on the state of quality

December 2003 The year 2003 saw Dr. Westgard in 36 different cities in the US and 8 foreign countries. Dr. Westgard met with or spoke to over 5,000 professionals in the clinical lab sciences this year. After this whirlwind of travel and talk, he gives thanks and offers some observations on the state of Quality Management Read this essay Back to Top

Autoverification: Taking QC to the next level - is that up or down?

January 2004 An updated version of this essay appears on the Nothing but the Truth about Quality book. 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? Read this essay Back to Top

Think Straight, Talk Straight

January 2004 An updated version of this essay appears on the Nothing but the Truth about Quality book. 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. Read this essay Back to Top

Quality Management - the Gospel According to ISO

In the face of failed CLIA regulations, where do we now turn? We may need to look to standards and practices outside the US. With this in mind, Dr. Westgard introduces a new series of articles about ISO and quality management. Guest authors Dr. Rogerio Rabelo and Dr. Daniel Perigo come to us from Fleury Diagnostics in Brazil, where they have experienced the ISO certification process. Read this essay Back to Top

More on CLIA and "Quality-Less Compliance"

An updated version of this essay appears on the Nothing but the Truth about Quality book. We've posted a large number of articles about the specifics of the Final CLIA Rule and the accompanying Interpretive Guidelines. But in addition to covering the specifics, we need to look at the big picture. Why did we get the CLIA Final Rule and Interpretive Guidelines the way that we did? Why did it take over ten years to complete? Why did manufacturer's QC clearance go by the wayside? How did we end up with "electronic QC" and "equivalent QC"? Read this essay Back to Top

Testing Equivalent Quality: A Better Way

An updated version of this essay appears on the Nothing but the Truth about Quality book. 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. Read this essay Back to Top

Is the Final Rule the Final Word?

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." Read this essay Back to Top

Hearings on Untruth and Unquality, Part I: Cracks in the Healthcare System?

May 2004. Dr. Westgard comments on the recent reports involving Maryland General Hospital and laboratory errors. The first in a series of articles on this developing story. Read this essay Back to Top

Hearings on Untruth and Unquality, Part II: Facts of the Maryland General Hospital Scandal

June 2004 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. Read this essay Back to Top

Hearings on Untruth and Unquality, Part III: Broken Windows at Maryland General Hospital

July 2004 There are two questions that all laboratory professionals are asking (or should be) about the scandal at Maryland General Hospital: How could it get this bad? and How could it take so long to discover the problem? Dr. Westgard and Sten Westgard try to answer those questions, and pose an even more important question: Are there more Maryland Generals out there? Read this essay Back to Top

Connecting the Dots to Reveal Patterns and Assignable Causes

July 2004. 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 difficulties and importance of quality control practices in the laboratory. Read this essay Back to Top

Maryland General Hospital Scandal, Part IV: Inadequate Inspections

August 2004. 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? Read this essay Back to Top

Maryland General Scandal, Part V: Tip of the Iceberg?

September 2004. 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? Read this essay Back to Top

The Quality of Laboratory Testing, Part I

September 2004. 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... Read this essay Back to Top

Remarks at the G2 Conference: "No Lab Left Behind"

September 2004. 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 here. Read this essay Back to Top

Vioxx and Values, Vaccines and Votes

October 2004. Note: this is an essay that mixes politics with laboratory healthcare. 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. Read this essay Back to Top

The Quality of Laboratory Testing, Part II: Methodology

November 2004. 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 first analysis quickly debunks the notion that QC is no longer necessary for US laboratories. Read this essay Back to Top

The Quality of Cholesterol Testing

December 2004. In the US, cholesterol testing has been discussed for decades. Specific quality requirements for precision and accuracy have existed on the books for years. But now we can determine if labs are meeting these goals. An analysis of over 9,500 laboratories in 5 different PT organizations reveals the difference between optimistic claims and actual achievements. Read this essay Back to Top

Bah, Humbug! Or, how I learned to stop worrying and love EQC

December 2004. Note: this is an essay that mixes politics with laboratory healthcare. Some of you may have been wondering how I’m coping after the November election. I’m pleased to tell you that I’m over it and have learned my lesson. The American people have spoken and elected to stay the course, right or wrong, so I am going to change my ways. No more liberal idealism; I’m going to accept neoconservative unrealism. Read this essay Back to Top

The Quality of Glucose Testing

January 2005. An analysis of over 9,500 laboratories in 5 different PT organizations reveals the difference between optimistic claims and actual achievements.. Read this essay Back to Top

The Quality of Calcium Testing

January 2005. 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? Read this essay Back to Top

Blowing the Whistle on the Tip of the Iceberg

January 2005. 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? Read this essay Back to Top

The Quality of Hemoglobin Testing

February 2005. GHb is a critical test for diabetes control, yet it's not one of the regulated CLIA analytes for proficiency testing. So in addition to determing the actual performance of laboratories for GHb, we need to determine how well labs should be performing. With enough data, though, both tasks can be accomplished... Read this essay Back to Top

The Quality of PSA Testing

May 2005. The October 2004 issue of Clinical Laboratory Strategies headlined an article “Prostate Cancer Research Declares PSA Era ‘Over’” [1]. Thomas Stamey, who is credited with creating the PSA era, now thinks the test is “all but useless.” Despite this, PSA testing continues across America. Does the performance of this test method match its utility? Read this essay Back to Top

Solutions for the Taxing Problem of QC

May 2005. QC is like taxes. Ask anyone about it, and it's unlikely that you'll hear a happy response. But like taxes, QC is something you can't avoid if you want a functional and productive society or healthcare community. Westgard QC provides a sneak peak at a program designed to help make the "QC tax" less burdensome on you. Read this essay Back to Top

The Quality of Coagulation Testing

June 2005. Over a dozen companies now offer Coag Testing at the Point-of-Care. But do we know how well Coag methods are performing back in the lab? And do those results provide us with insight into performance issues for POC testing? Read this essay Back to Top

The Quality of PT Sigma metrics

October 2005. In our ongoing series on the Quality of Laboratory Testing, we've been looking at as many PT groups as possible. But the questions arises, are some PT group estimates better than others? We take a closer look at CAP PT Sigma metrics. Read this essay Back to Top

Links to India, Part I

October 2005. 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. Read this essay Back to Top

Method Performance and Test Quality: Same thing?

October 2005. A question that often comes up when Dr. Westgard makes a presentation: 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?) Read this essay Back to Top

Links to India, Part II

October 2005. The second part of a discussion of Dr. Westgard's four-city tour of India. Read this essay Back to Top

Links to India, Part II

October 2005. The second part of a discussion of Dr. Westgard's four-city tour of India. Read this essay Back to Top

QC: Not just a technicality

November 2005. 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. Read this essay Back to Top

100,000 Miles to Quality: 2005 in Review

December 2005. Dr. Westgard visited a dozen countries and dozens of cities this year. At the end of this year of travels, he sends out thanks to countless individuals who came to listen, to talk, and to learn together about quality. Read this essay Back to Top

Unannounced Inspections: Unlikely to Improve Quality

January 2006. Across the US, laboratorians are growing pale. Many of them will no longer know the exact date of their inspection. But will "surprise" inpections improve quality? Read this essay Back to Top

Hopeful Healthcare in a Fearful Society

February 2006. What's the State of Healthcare in the US? Can HSAs, restricted liability rights, P4P, and CPOE save us? An essay that strays outside the laboratory. Read this essay Back to Top

Quality Indicators and Benchmarks

March 2006. Are you ready for the latest lists for the laboratory? IQLM is preparing a list of Quality Indicators, as well as a list of things that physicians don't like about laboratorians, and a list of things that laboratorians don't like about physicians. In all of this "Top Tenning," is there anything useful? Read this essay Back to Top

Trouble with Tracking Test Results

Mach 2006. The New York City Board of Health and Mental Hygiene has amended the city’s Health Code to require laboratories to report all hemoglobin Alc test results in order to monitor diabetic patients. Will monitoring approximately 100,000 results each month improve quality for anyone? Read this essay Back to Top

Open Letter to CLSI

April 2006. Numerous CLSI committees are formulating the standards for QC for the Future right now. In light of recent evidence that analytical quality is not as good as most assumed, this is an open appeal to those decision-makers and deciders all across the country to remember that statistical QC is a critical tool for the laboratory. Read this essay Back to Top

What's the Laboratory's Core Competency?

May 2006. Some gas stations around the country ran out of gas this month. Would you go to a gas station that had no gas? Now, would you use a laboratory that had no quality in their testing? Read this essay Back to Top

Update on Quality Design Tools

June 2006. There are a variety of tools and programs available to those who want to implement Sigma metrics and QC Design in their laboratory. Some are free, some are not, and some new tools are coming soon... Read this essay Back to Top

GAO Report on CMS: it's out

June 2006. Remember Maryland General? Part of the outcome was a Congressional request for a GAO (Government Accountability Office) investigation of CMS and its related agencies. Well, the report is finally out. And it's not kind. Read this essay Back to Top

GAO Report Recommendations: the good, the bad, and the irrelevant

July 2006. with Sten Westgard, MS As a result of the GAO investigation, there are 13 recommendations being made in their report. We've analyzed each point to determine if they're useful, bizarre, or just irrelevant. Read this essay Back to Top

GAO Report: the agencies respond

August 2006. with Sten Westgard, MS The final GAO report contained not only recommendations, but preliminary responses of those affected by the recommendations. See what CMS, CAP, JCAHO, and COLA had to say to the GAO when they saw the first draft of the report. Read this essay Back to Top

Rumors of my Retirement are somewhat exaggerated...

September 2006. Yes, I am retiring. But only from one job. Read this essay Back to Top

Thank you...

September 2006. There are few moments in life when you can take stock of your life in the presence of friends, colleagues and family. Read this essay Back to Top

2006: Links to Argentina

October 2006. Dr. Westgard recently attended the CALIDAB conference in Argentina. Here are a few highlights. Read this essay Back to Top

2006: Links to Spain

November 2006. Dr. Westgard recently attended the Spanish society of Clinical Chemistry and Chemical Pathology in Bilbao, Spain. Here are a few highlights. PLUS, a special Powerpoint download with Dr. Westgard's presentation translated into Spanish. Read this essay Back to Top

GLP for Lab QC: Part I

November 2006. Did you know the ASCP held a teleconference this year on " A How-Should-I guide to Laboratory Quality Control." They cited the lack of "Good Laboratory Practice" standards for QC in the laboratory. If only they had looked at the recent CLSI standards, they would have found some. Dr. Westgard explains the new C24-A3 standard and how it can lead you to good laboratory practices in quality control. Read this essay Back to Top

GLP for Lab QC: Part II

December 2006. Some practical advice on the proper set up, implementation and use of QC, as well as a discussion of "standard deviations" from Good Laboratory Practice. Read this essay Back to Top

2006: Links to South Africa

December 2006. Dr. Westgard reached his fifth continent this year in a tour of South Africa. See what he has to say about this visit and the topic: "QC and Life in the Lab" Read this essay Back to Top

Why We Write...

December 2006. with Sten Westgard, MS After ten years of Westgard Web and more than 100 essays written, Dr. Westgard reflects on the reasons for writing for the Laboratory Professional audience on the Internet. Read this essay Back to Top

Global and Local Imperatives in US Healthcare

January 2007. After traveling to five continents in 2006, Dr. Westgard gained a new perspective on US healthcare. As our healthcare system fails, the world is watching. Read this essay Back to Top

In 2007, Method Validation Skills are still Vital

January 2007. A recent "false epidemic" makes it clear that rigorous statistical skills are not optional in the new era of instrument diagnostics. Read this essay Back to Top

Instrument Claims: Should they be Statistically or Clinically Significant? Truthful Claims may not be enough?

February 2007. This year will see the launch of a fleet of new regulations and standards for the laboratory and the manufacturer. But is it really enough to verify that an instrument does what the manufacturer says it does? Don't we need to assure that the instrument does something clinically useful, too? Read this essay Back to Top

Truth, Trueness, and Truthiness: Some Truthful Guidance about Trueness, Uncertainty and Quality

February 2007. We need some truthful guidance about Trueness, Uncertainty and Quality. This year's regulations feature new terminology that adheres to ISO conventions. As we leave behind our familiar concepts of precision, bias, and total error, are we gaining anything? Are we just changing names, or are we changing our goals, too? Read this essay Back to Top

Spotting Quality Internationally: The Antwerp Meetings

April 2007. This year's "Quality in the Spotlight" conference tackled the subject of auditing and inspections. Dr. Westgard reviews some of the highlights. Read this essay Back to Top

The Meaning and Application of Total Error

April 2007. While the scientific community has grown comfortable with the once-revolutionary concept of "total error", novices and newcomers are often puzzled by the term. Dr. Westgard answers a few "back to basics" questions about total error and its role in laboratory testing. Read this essay Back to Top

CLSI faces the Challenge of Quality

April 2007. Dr. Westgard attended the recent CLSI workshop to learn about forthcoming standards on risk assessment, quality, and (E?)QC. It seems the rumors of the death of Options 1, 2, and 3 may have been exaggerated... Read this essay Back to Top

The Health of US Healthcare

June 2007. A recent report on the quality of US Healthcare doesn't put us in first place, despite spending far more on healthcare than other nations. Why is that? Read this essay Back to Top

Errors In, Before, and Behind the Laboratory

July 2007. Several recent studies assert they have calculated the rate of error in laboratories, pre-analytical, analytical, and post-analytical. But what those numbers mean depends on what's being counted and who's doing the counting. Read this essay Back to Top

"But is it really out?"

September 2007. with Sten Westgard, MS We may want to do the Right QC Right, but often our adjustments of QC Theory to fit our 'real world' laboratory end up making us do the Wrong QC Wrong. This essay discusses why and where there are the differences between the theory of QC and the practice of QC. Read this essay Back to Top

A War of Words in Laboratory Terminology?

September 2007. Total Error. Trueness. Uncertainty. Can these terms coexist? Under ISO, will defining an allowable error for a test become unacceptable? Will the embrace of ISO accreditation mandate the rejection of all non-ISO-conforming terminology and concepts? The debate - and the future - is uncertain. Read this essay Back to Top

A War of Words in Laboratory Terminology, Part II: Concepts and Terminology in a Changing, Uncertain World

October 2007. Trueness. Uncertainty. Accuracy. Precision. Why are there so many definitions for the same terms? Dr. Westgard traces the history of metric concepts in the clinical laboratory. See when and where ISO, IFCC, and CLSI began introducing new terminology into the lab. Read this essay Back to Top

A War of Words in Laboratory Terminology, Part III: Intended Applications and Customers

October 2007. Looking beyond the terminology of Trueness and Uncertainty, Dr. Westgard examines the intended uses and customers of these terms. If we spend our time fighting about Metrological definitions, are we serving the patient? Read this essay Back to Top

Equivocal QC: Coming to a Laboratory near you

November 2007. Despite the universal complaints, Despite the CMS admission that "We blew it", Despite a complete lack of scientific validity, "EQC" options are coming to a laboratory near you. See how it's going to happen. Read this essay Back to Top

The Quality of Glycated Hemoglobin (GHb) The War of Words in Laboratory Terminology, Part IV

November 2007. After traveling to five continents in 2006, Dr. Westgard gained a new perspective on US healthcare. As our healthcare system fails, the world is watching. Read this essay Back to Top

EQC, AQC, and FDA QC Clearance: From control to compliance; from compliant to complicit

January 2008. recent audioconference explained how EQC, despite its dubious scientific validity, is no longer educational, but policy. The audioconference brought up the possibility once more that the FDA will provide a QC clearance option for manufacturers. (Hint: Don't get your hopes up...) Read this essay Back to Top

James O. Westgard, PhD, is an emeritus professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.