The Westgard Rules

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.

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.

Thank you, Rochester

By Sten Westgard, MS

We got a big dose of "Minnesota Nice" during our workshop in Rochester, Minnesota. The participants were very helpful - some of them showed up earlier than we did and helped set up the table arrangements for the room! There really is a different culture in the midwest, a spirit of kindness and cooperation that you don't always find in states that lack prolonged sub-zero winters.

When you think of Rochester, Minnesota, your first thought might be the Mayo Clinic. While we were very happy to have many Mayo Clinic attendees, the workshop was actually hosted by the Olmsted Clinic. That's the other hospital in Rochester:

There's a pretty good reason why we picked Olmsted as the host. Take a look at the picture below, where the Medical Director of Olmsted is posing with us:

I realize the picture is small, but I'm guessing you can see a family resemblance. That's right, the Medical Director of Olmsted Clinic is Dr. David Westgard, the brother of Dr. James Westgard. So the day was filled with an excess of Westgards. Dr. David Westgard introduced Dr. James Westgard, and Sten Westgard also presented a few of the topics. In addition to an education on method validation, the audience got an introduction to the Westgard family dynamics. Statistics and North Dakota jokes actually work well together

Thanks again to Olmsted for hosting this workshop and providing us with an excellent opportunity for a mini-family reunion.

Westgard Interview on the Web, Part Two

Posted by Sten Westgard

Back at the 2008 AACC conference in Washington, DC, Dr. Westgard sat down for an hour with some friends from COLA. They interviewed him on a number of topics, from his personal story and the journey of his career in laboratory medicine, to the origin and use of the "Westgard Rules."

You can see the second part of this video interview on the Advance website, sponsored by COLA.

[ Here's the link to first part of the interview.]

The release of this interview coincides with the run-up to COLA's Symposium for Clinical Laboratories. Dr. Westgard will give the keynote address for this symposium and he will join experts like Lucia Berte, Greg Cooper, Judy Yost, and many others, to discuss quality and laboratory medicine. This symposium is taking place on September 25th through the 27th, in Scottsdale, Arizona.

These excerpts won't be up for much longer. So if you want to actually see and hear Westgard on the Web, do it ASAP.

Westgard interview on the web

Posted by Sten Westgard

Back at the 2008 AACC conference in Washington, DC, Dr. Westgard sat down for an hour with some friends from COLA. They interviewed him on a number of topics, from his personal story and the journey of his career in laboratory medicine, to the origin and use of the "Westgard Rules."

You can see the first part of this video interview on the Advance website, sponsored by COLA.

The release of this interview coincides with the run-up to COLA's Symposium for Clinical Laboratories. Dr. Westgard will give the keynote address for this symposium and he will join experts like Lucia Berte, Greg Cooper, Judy Yost, and many others, to discuss quality and laboratory medicine. This symposium is taking place on September 25th through the 27th, in Scottsdale, Arizona.

I believe more excerpts of this interview will be posted soon, but they may not be up for long. So if you want to actually see Westgard on the Web, do it ASAP.