The Westgard Rules

What's New: November 2008

New Download: Sigma-Metrics Tool (and audioconference presentation)

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.

http://www.westgard.com/audiodownload.html

Westgard Sigma Analysis: A new direct 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?

http://www.westgard.com/qcapp53.htm

Interview: Dr. R. Neill Carey (A brief introduction to EP 15)

We were fortunate 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.

http://www.westgard.com/interview9.htm

Thinking about Three Sigma: 2 thoughts on troublesome performance

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?

http://www.westgard.com/lesson87.htm

Talking about a Training Trilogy in MLO

By Sten Westgard, MS

Dr. Westgard is the featured executive profile in the November 2008 issue of Medical Laboratory Observer. The editors asked him how he developed three popular training references: Basic QC Practices, Basic Method Validation, and Basic Planning for Quality.

What progress will we make?

by Sten Westgard, MS

As regular readers of Westgard Web know, Dr. Westgard has not been shy about making political comments in elections past. 

This election cycle, we didn't make many political comments on the blog or the website. It seemed to us that the candidates and the parties did just fine by themselves.

Over the past few days, we have received many emails of hopes and congratulations from people all around the world who have watched the US Presidential race. We thank you for those kind messages. It is a testament to the interconnectedness of the world that we all have a stake in each other's politics.

We celebrate the election of the new President. But the celebration can be only temporary. The real work remains before us:

"This victory alone is not the change we seek - it is only the chance for us to make that change. And that cannot happen if we go back to the way things were. It cannot happen without you."
President-Elect Barack Obama, November 4th, 2008, victory speech

Talking about CLIA and Risk in Clin Lab News

by Sten Westgard, MS
Updated 11/7/08

Dr. Westgard is quoted in the November 2008 issue of Clinical Laboratory News

in their report on "Risk Management for Clinical Labs" [subtitle: As CLIA Turns 20, A New QC Paradigm Lies Ahead for Labs] . Here's the most interesting quote:

One of the most outspoken critics of the EQC guidelines has been James Westgard, PhD, FACB, emeritus professor in the department of pathology and laboratory medicine at the University of Wisconsin Medical School and president of Westgard QC, Inc. “So what are equivalent QC procedures? Equivalent in performance? Equivalent in detecting medically important errors? Equivalent in assuring the necessary desired quality is achieved?” asked Westgard at a September 4 AACC audioconference called “New Directions in Laboratory QC: EQC, Alternate QC and Risk Assessment.” “No, it’s none of the above. It’s just a name. It has nothing to do with any practical meaning in terms of what we think of equivalents. It’s just a name,” he said.

Back a few years ago, there were more critics of Equivocal QC, for example CAP, but then their deeming status came up for review. Now all the deemed providers have implemented equivalent QC options. CMS flexed its muscle, and now there are fewer people to be outspoken.

The whole article(pdf) is worth a read. Again, one of the most interesting details is how the FDA might handle Manufacturer Risk Information - and use it against manufacturers in the event of a problem:

Steven Gutman, MD, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety indicates that FDA will not directly review a manufacturer’s risk assessment material. “Because they’re providing straight-forward information on risks and risk management, we would view that as an acceptable practice, and there might be various formats for them to do that,” Gutman explained. “It might be technical bulletins, it might be on their websites, but it wouldn’t be a part of FDA-sanctioned labeling unless they violate FDA regulations, in which case our compliance program would become concerned.” Gutman said the FDA would look to see if companies were going overboard with explicit or implicit claims about their products, reviewing the information only if the agency thought there was a problem.

As we noted before in What are the Risks of Communicating Risks?, this is a tough spot for a manufacturer.

Update: You can now download Dr. Westgard's complete presentation from the September 4th, 2008 audioconference. The pdf download includes his slides, two Sigma-metrics QC Design charts, and instructions on how to use them.