On the Blog:
On the Blog:
Happy Holidays 2008 and a Hopeful New Year 2009
HbA1c for screening and diagnosis of diabetes?
Recent coverage of estimated average glucose (eAG) and the rise of HbA1c as the method for diagnosis of diabetes raises an obvious question: Are HbA1c methods and results of better quality than glucose methods and results? Dr. Westgard looks at the numbers.
High Reliability Testing: Reluctance to Simplify
In our next lesson on High Reliability, we talk about a deceptively simple principle: the reluctance to simplify. When everything about your organization is dedicated to streamlining and making things more efficient, how do you maintain the ability to know all the real complexity of your processes?
Quality Requirements for Dogs, Cats, and Horses?
In a new paper, two scientists perform a literature survey of the veterinary diagnostic literature and attempt to calculate basic quality requirements for common analytes - for the non-human species.
New Westgard Download: Sigma-metrics Tool
On September 4th, 2008, Dr. Westgard spoke as part of the AACC audioconference on "New Directions in Laboratory QC" - which was subsequently quoted in the Clin Lab News article on Risk and CLIA. We are pleased to make available Dr. Westgard's complete presentation, as well as two Sigma-metrics Charts and instructions on how to use them in QC Design.
Westgard Sigma Analysis: new HbA1c method
At the 2008 AACC/ASCLS convention, a poster was presented for a new direct enzymatic assay for %HbA1c. How does it stack up against HPLC and immunoassay methods? How do you judge a method when you've got multiple comparison methods and multiple quality requirements?
A brief introduction to EP 15 - interview with the CLSI committee chair, R. Neill Carey
We were fortunate enough to get R. Neill Carey, PhD, the chair of the CLSI EP 15 committee, to present and explain that new standard at the Chicago Method Validation workshop. He also contributed a chapter to the new Basic Method Validation manual on the same topic. But for those who have never heard of EP 15 before, we conducted a short interview with Dr. Carey. This short introduction to EP 15 may pique your interest in this new guideline.
Thinking about Three Sigma
In a previous lesson, we discussed some possible actions to take when the Sigma-metric for a method is higher than Six. But what about those methods with low Sigma-metrics? What do you do when Sigma analysis delivers bad news?
Surpassing Six Sigma: 7 Thoughts on Superior Quality
Recently, we've been seeing methods by some instruments that perform well beyond Six Sigma. What are the implications when a method is better than world class? Does this change how we should operate those tests?
Westgard Sigma Analysis: Abbott ARCHITECT c8000
At the 2008 AACC/ASCLS convention, Sten Westgard was a co-author on a study examining multiple instruments on multiple sites. When a large healthcare system has a lot of the same instrument, how do the instruments perform?
High Reliability Testing: Preoccupation with Failure
In the second lesson on High Reliability, the first principle of HROs is discussed. Preoccupation with failure sounds like a bad thing, so why is it a key behavior in highly reliable organization?
Westgard Sigma Analysis: POC hematology instrument
A recent evaluation paper in a prominent journal took a look at a new POC hematology instrument. They concluded that the performance was "within acceptable limits." When the bar is that low, what's the actual Sigma performance?
Time to Engage in Measurement Uncertainty
In the ongoing War of Words, it's time to hear another voice. Dr. Dietmar Stockl, an expert from across the Atlantic, provides us with a detailed essay explaining how measurement uncertainty can be useful to the laboratory - and even co-exist with Total Error.
The Blog is Back!
Yes, the Westgard blog is back. Regular visitors will remember that back in 2006, Westgard QC dipped its toe in the blog waters, but after a dozen or so postings, the blog went silent. Now it's back, with better features, improved commenting, and a new look. Here are a few of the recent postings:
Update on EP22, EP23 and "Alternate QC"
The search for a different way to do QC continues. And continues. Read the latest developments, from a meeting at the AACC/ASCLS convention of the CLSI committees on EP 22 and EP23.
We were happy to see the hundreds of people who visited the booth or attended the lectures given by Dr. Westgard and Sten Westgard. If you weren't able to attend the convention, you can find out quite a bit by reading our reviews and follow-ups from the show.
A different approach: High Reliability Testing
Lean, Six Sigma, ISO and Risk Management aren't the only Quality management systems out there. There's at least one other system called High Reliability Organiation (HRO) theory. A recent report details how HRO can help improve healthcare quality.
The Quality of Proficiency Testing
A recently-released report from the CDC dared to ask the big question: is Proficiency Testing effective? Not only that, it dared to recommend a significant change in the CLIA statutes.
Westgard Sigma Analysis: Roche cobas c311
At the 2008 AACC/ASCLS convention, there is a poster with performance data on the new Roche cobas c311. What's the Sigma of these new methods?
New Edition! Basic Method Validation
We're proud to announce the publication of the third edition of this essential laboratory reference. This concise guide to method validation has been revised, updated, and expanded. We've added new chapters covering ISO, CLSI guidelines, and Sigma-metrics. Download excerpts now and get an extra discount if you place an online order.
New Online Training in Method Validation
To coincide with the release of the third edition, the online training course in method validation has also been updated and expanded. New tools, new supplementary materials, even a streaming video presentation on the "Secrets of Method Validation." The most comprehensive course in method validation just got better.
When Quality depends on the company you keep
A recent report from the CDC identified a number of problems with current proficiency testing. Among those problems, the group SD quality requirement. What is it? Why is it a problem? What can be done about it?
Westgard Sigma Analysis: a POC multitest system
When a new POC instrument reports it has great precision numbers, is that all you need to know about performance?
CAP talks about ISO 15189:2007
Earlier this year, CAP announced that it would offer ISO 15189:2007 certification to laboratories by the end of this year. What does this mean for laboratories? Westgard Web asks the CAP ISO staff.
Biologic Variation Database: the 2008 update
Dr. Carmen Ricos and her colleagues have graciously provided us with the fifth edition of their biological variation database. New data, new analytes, and new desirable specifications - a most valuable contribution to the field.
See the update highlights
See the References
See the Reference List
See the Desirable Specifications for Imprecision, Inaccuracy, and TEa
Waiting on the FDA for alternate quality control?
Earlier this year, CMS held out hope that the FDA would create another option for quality control: Alternate QC (AQC). Later, the FDA said it couldn't do that right now, but that it remains open to the possibility. But, just how feasible is it for today's FDA to tackle a new clearance option?
Westgard Sigma Analysis: GHb and cobas 6000
This month we take a Roche cobas 6000, we apply the different analytical quality requirements for GHb and evaluate its performance. What requirements should you pick? What rules should you use?
The Skinny on QC? Are Quality Requirements Lean?
In light of the publication of the fifth edition of the Ricos et al biologic variation database, it's worth contemplating one question: what's the quality of quality requirements? In the parlance of the latest management trend, are quality requirements "Lean"?
What we can learn from World Class Methods
Over the past few months, Westgard Web has performed several Sigma analyses of Abbott ARCHITECT methods, all with superior results. We decided to go straight to the source and ask them what they're doing that produces this level of quality. Turns out, they're just doing all the things that we should be doing in the laboratory...
Clinical Chemistry Citation Classic (sub required)
In the March 2008 issue of Clinical Chemistry, Dr. Westgard tells the story behind the seminal 1973 paper by Westgard and Hunt on the "Use and Interpretation of Common Statistical Tests in Method Comparison Studies." This is the paper that laid the foundation for method evaluation/validation studies for laboratory tests.
New Year, New Store
We've updated and upgraded our online store. We're using Yahoo and Paypal to provide the store and payment functionality. See the thumbnail below to get an idea of what the store looks like, then Come check it out - at www.westgardqc.com - and let us know what you think.
2008: The Year of EQC, AQC, or no QC at all?
A recent audioconference explained how EQC, despite its dubious scientific validity, was no longer educational, but policy. The audioconference brought up the possibility once more that the FDA will provide a QC clearance option for manufacturers. Don't get your hopes up...
Sigma metrics of POC glucose instruments
Scientists at the Mayo Clinic performend an interesting study of multiple POC glucose methods to evaluate their performance. Using this valuable data, we apply Westgard Sigma analysis. Do you think there's world class performance at the point of care?
Evaluating GHb quality requirements
In the recent essay on Guidelines for GHb, a number of different quality requirements were discussed and proposed. So what's happening on the instrument? Taking an Abbott Architect c8000, we apply the different analytical quality requirements and evaluate its performance.
The Quality of Glycated Hemoglobin (GHb)
Part Four of Dr. Westgard's series on the War of Words in the Laboratory shows the impact of lax standards on one of the most important tests in the laboratory. Guidelines for GHb have been issued in 2002 and 2007 - but are they on target? Is there any evidence in this evidence-based medicine guideline?
Equivocal QC: Coming to a Lab near you
Despite universal complaints about the CMS "EQC" options, despite the CMS admission that "we blew it", and despite a complete lack of scientific validity, these policies are coming to a laboratory near you. See how it's going to happen...
Guest Essay: Frequency of QC and Patient Safety
We're delighted to present this guest essay from Dr. Kent Dooley, an astute reader who has done serious thinking about what patient safety implies for quality control. If labs are serious about patient safety, should they be reducing their quality control?
Sigma metrics: Abbott Architect c16000
Using 2007 AACC poster data, we take another look at Abbott's newest, biggest chemistry instrument. Does the site evaluation corroborate the manufacturer's evaluation?
A War of Words in Laboratory Terminology? Part III
Looking beyond the terminology of Trueness and Uncertainty, Dr. Westgard examines the intended uses and customers of these terms.
A War of Words in Laboratory Terminology? Part II
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.
A War of Words in Laboratory Terminology?
Have we reached the point where a "total allowable error" is no longer acceptable? Shall we stop defining how good a test should be - just so we can insist that tests shouldn't be in error at all? The ISO terminology of trueness and uncertainty and its passionate advocates might be saying just that.
"But...is it really out?"
We get a lot of email at Westgard Web, and a lot of it asks questions about specific situations where the theory of QC might say a control is out, while the "real world" laboratory believes that it's actually "in." This essay discusses why and where there are the differences between the theory of QC and the practice of QC.
Ten ways to do the Wrong QC Wrong
Taking a cue from the previous, we look at a "Top Ten" list of real world QC scenarios and see how laboratories are getting their QC wrong.
Why We Write
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.
New "Westgard Rules" worksheets?
If the rules are 25 years old, why are we offering "new" worksheets? Well, it came to our notice that the current worksheet graphically describes the "classic" multirules, but no similar worksheets exist for our other recommended multirule combinations. Now we've remedied that - in one download, you can see the "classic" rules, as well as modern recommendations for instruments with 2 controls and 3 controls per run.
"Westgard Rules" at 25 years - an audio download
By some accounts, the "Westgard Rules" turned 25 years old in 2007. In celebration of this anniversary, the webmaster interviewed Dr. Westgard by phone about the past, present, and future of multirules and QC. ( Please note this file is 13.5 MB. Our apologies for the quality of the recording - Dr. Westgard was on his way to South Africa at the time). In the future, we plan on offering regular "podcasts" for your convenience.
Good Laboratory Practices, Part II
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.
Good Laboratory Practices for Statistical QC.
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.
A Multichemistry analysis: 16 years later
The unspoken assumption in laboratories and diagnostics is that we're getting better all the time. Our new systems are better than our old ones. But does the data show this? Just looking at a Westgard et al. paper from 1990 and a collection of recent instrument performance data provides a challenge to this thinking.
Are "Westgard Rules" efficient and cost effective?
David Plaut, longtime friend of Dr. Westgard, recently collaborated on a multisite evaluation of the implementation of "Westgard Rules" in the laboratory. The poster, originally at the 2005 AACC conference, is now available in an expanded format online. And we thank David for it.
The War on Error: Complete Victory or a Long, Hard Slog?
As part of our continuing series on Patient Safety concepts, we explore the nature of Error, its varieties and occurences in the lab, and consider the proposed changes in QC through the perspective of Swiss cheese. No. We're not kidding. Swiss cheese.
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?
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.
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?
The Quality of PT Sigma metrics
In our 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.
Multistage QC Design with EZ Rules 3
See how EZ Rules 3 makes Multistage QC Design possible. The most advanced QC techniques are easy to a sneak peak at a new version of EZ Rules we'll be releasing soon. This new version combines the best features of Validator and EZ Rules, and adds some new twists as well.
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