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.

Errors in, before, and behind the laboratory?
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.

Sigma metrics: Abbott Architect c16000
Using 2007 AACC poster data, we take a look at Abbott's newest, biggest chemistry instrument.

The meaning and application of Total Error
Dr. Westgard answers a few back to basics questions about total error and its role in laboratory testing .

Truthful Guidance about Trueness
The regulations emerging this year will feature new terminology that adheres to ISO conventions. As "Trueness", "Uncertainty" and other new terms crowd out 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?

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.

Basic QC Practices Manual
SECOND EDITION!!

QC - Levey-Jennings Charts

QC - Back-to-Basics

QC - The Idea 

QC - The Multirule Interpretation

An Open Letter on Risk Management and "EQC"
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.

CLIA manual Now available
To address the CLIA Final Rule and Interpretive Guidelines, Dr. Westgard, Dr. Sharon Ehrmeyer, and Dr. Teresa Darcy have written a new manual covering all the critical changes and new lab responsibilities. You can preview the first two chapters of this manual available free.

Is this the end of EQC 1, 2, 3?
The 2005 news on Equivocal QC was not supportive of options 1, 2, or 3. Professionals, manufacturers, even the regulators themselves are unhappy. We're pleased to provide a summary of what was said and by whom, as well as what that means for you. And find out if these options are now optional - or simply obsolete.

Back to the Future: CLIA EQC Option 4
A recent meeting held by the Institute formerly known as NCCLS proclaimed EQC as the "QC for the Future", then promptly proposed a new option that would circumvent the current options. Even more interesting, the new option comes out of CLIA's past...

Bah, Humbug! A look back at 2004
This was quite a year, full of high points and low points. Perhaps the biggest issue in US labs was EQC. In the spirit of Jonathon Swift, we make a modest proposal.

Analysis of the Rationale for "Equivalent QC"
In presenting a scientific basis for "Equivalent QC", CMS cites the NCCLS documents M2-A. What is this document and how does it provide the rationale for "Equivalent QC"? Dr. Westgard investigates.

A Rationale for "Equivalent QC"?
Traffic on the AACC POC listserv has been fast and furious lately. An open letter was posted questioning the scientific rationale behind equivalent QC procedures. CMS has responded. The complete letter and response are posted here for your review.

Is the CLIA 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."

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.

Lies, Damn Lies, and "Equivalent" QC
When the 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 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", when our testing and patients need more QC?

CLIA Final Rule: The Interpretive Guidelines
On January 12th, CMS released the Appendix C of the State Operations Manual. These are the Interpretive Guidelines for the CLIA Final Rule, and they contain some major changes in how the CLIA regulations will impact the laboratory. Get the first review of these guidelines from Dr. Sharon Erhmeyer and Dr. Westgard.

CLIA Final Rule: "Equivalent" QC Procedures
The Interpretive Guidelines on the final CLIA Rule contain a startling reduction in the requirements for QC. Dr. Westgard explains what this new practice is, and why it's fatally flawed.

CLIA Final Rule: Appropriate QC Procedures
If we accept 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 you determine it?

CLIA Final Rule: Method Validation Process and Procedures
Starting on April 24, 2003 all non-waived laboratory methods must be validated. This includes methods that were previously exempted from validation. In light of these new responsibilities, Dr. Westgard reviews the process and procedures of method validation.

CLIA: Statistical sense, sensitivity, and significance
Given the new CLIA Final Rule method validation responsibilities, laboratories have to become smarter about their use of statistics. Dr. Westgard examines the best uses and interpretations of statistics for method validation. Some current practices are not as good as you might think.

CLIA: What does it mean for Method Validation?
Dr. Sharon S. Ehrmeyer provides more analysis of the new CLIA Final Rule. Now that there are only 2 categories of tests - waived and non-waived - what experiments must be performed on non-waived tests? JCAHO and CAP requirements are also discussed.

CLIA: Perplexity about Personnel and Complexity
Dr. Sharon Ehrmeyer, PhD, well known for her grasp of CLIA and regulatory affairs, offers us her view of the new CLIA rules. In particular, she clarifies how these new rules will impact personnel requirements and qualifications in the laboratory.

Unannounced Inspections
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?

GAO recommendations: the agencies respond
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.

GAO recommendations: good, bad and irrelevant
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.

GAO report on CMS is out
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.

Blowing the Whistle on the Tip of the Iceberg
The Maryland General lab is back in compliance. So we can breathe easier, right? Actually, no. Now three other labs have been found deficient in Maryland. Why are more labs having problems? Why is this scandal still growing?

Maryland General, Part V: Tip of the Iceberg?
Was the scandal at Maryland General Hospital a case of a "few bad apples" or is just the tip of the iceberg? New studies and analysis...

Maryland General, 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?

Hearings, Part III: Broken Windows at Maryland General Hospital
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 problem? Dr. Westgard and Sten Westgard try to answer those question, and pose an even more important question.

Remarks at the G2 Conference: "No Lab Left Behind"
On September 30th, 2004, Dr. Westgard received the 2004 Leadership Award for Lifetime Achievement from the Washington G2 Lab Institute on September 30th. His thanks and remarks upon receiving this honor are now available.

"Westgard Rules": Best Practices
So we've catalogued some of the worst abuses of "Westgard Rules." What about the best uses? What's the best way to use "Westgard Rules" - When, Why, How and Who, too?

"Westgard Rules": Abuses, Misuses, and In-excuses
WARNING! You may not want to read this article. It's a sobering list of all the common mistakes made by manufacturers and laboratories when they implement the "Westgard Rules." As it turns out, when your software or instrument or LIS claims to have "Westgard Rules," it might not be true or even useful.

$aving the Cost$ of Poor Quality
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 for your use.

It's not Rocket Science: Lessons from the Shuttle Disasters
The loss of the Columbia and Challenger Shuttles were not just technical failures - they were also a result of a culture at NASA that devalued safety. As we look at the Shuttle failures, how can we be sure that labs aren't doing the same thing?

Internal Quality Control: A Free Download
In the November 2003 issue of the Annals of Clinical Biochemistry, Dr. Westgard presented a paper titled Internal Quality Control: planning and implementation strategies. This is a concise introduction (or refresher) to the theory and practice of QC. And by the generosity of the publisher, you can download this paper free.

A Six Sigma Method Decision Chart
We are happy to make available an upgrade to our free Method Decision Chart. Now this spreadsheet gives you an instant Six Sigma metric of your method performance. And special thanks to the contributor and creator of this spreadsheet, Alex Bragat.