The Westgard Rules

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.

30 Years of Workshops!

Originally posted August 7th, 2006

One of the more significant milestones passed at the AACC/ASCLS conference was the 30th year of the "Concepts and Practices in the Evaluation of Laboratory Methods" workshop. This workshop, taught by Carl Garber, PhD, R. Neill Carey, PhD, and David Koch, PhD, is now the longest continuously taught workshop at the conference.

An article celebrating this anniversary was in the Monday "Convention Daily" of Clinical Laboratory News (Title: Workshops Offer Participants New Lab Tools and Skills: Instructors of 'Evaluation of Laboratory Methods' Mark 30th Year'). Unfortunately, the article is not available online (yet), so I will quote a short passage where Neill Carey and Carl Garber talk about the 'early years' of the workshop:

"'At the time, what we were suggesting was a fairly new concept,' Carey recalled. 'Before that point, people hadn't talked much about making decisions on the acceptability of methods based on measuring errors.' Garber explains that their workshop has always been intended to provide practical advice for laboratorians on the use - and the misuse - of statistics. 'Our focus has consistently been on clinical significance - where the rubber meets the road,' he said 'Through the years we've tried to help our colleagues better understand what the clinician requires in terms of allowable error and variation on a test result.'"

I worked with Carl and Neill and David when they worked at the University of Wisconsin Hospital and Clinics in Madison.  They are a part of that "Wisconsin mafia" that has helped keep quality and statistics at the center of laboratory testing. I must also admit I had a hand in developing this workshop, too. We published a series of papers  in the early 1970s on the "proper use of statistics in evaluating methods" and presented them in a workshop in 1976 at the American Society of Medical Technology. The next year, 1977, I was heading over to Uppsala, Sweden, for a sabbatical (where my interest in QC would begin and where the "Westgard Rules" would be developed). I recommended that Carl and Neill take the workshop to the AACC conference (David Koch would join them in 1982.). And they have taught that workshop ever since.

Over the years, they have applied continuous improvement to their Method Evaluation workshop, modifying, updating, and adding material. The workshop, now part of the new AACC University, is a tightly packed four hours that includes not only the basic statistical studies for method validation, but also Six Sigma, CLIA regulations and CLSI guidelines. There's probably no other workshop that is so stuffed with information. If you ever get a chance to come to the AACC conference, I highly recommend attending the workshop. You'll learn a lot - either something new or something you've forgotten.

What they've accomplished is the long distance marathon of conference programming. Few people would have the stamina, diligence, and determination to make a fresh presentation every year on this important topic. But Carl, Neill, and David have done it and I hope they continue to do it for decades to come.

So congratulations again.

Westgard Workshops 2006, Part II: What was unsaid

originally posted June 13, 2006

The first day of the Westgard Workshops covered Standards and Practices, Indicators and Guidelines.

We were lucky enough to have presentations by both CAP and JCAHO officials, detailing the latest changes in the checklists, guidelines, patient safety goals, etc. I can't do justice to all the details here. There are simply too many changes year to year to cover in a short note. What's frightening is that ever since the "final" CLIA rule in 2003, every year is bringing a huge set of changes. You would think that a laboratory would need to have a FTE devoted just to tracking the changes in the regulations.

Obviously, unannounced inspections were a hot topic. But even more interesting was what wasn't being said.

With the CLSI committees working on several new guidelines for both manufacturers and laboratories (EP22 and EP23), with CLIA still formulating what "Option 4" is going to be, this year is mainly about anticipation. Cross your fingers, because we are really hoping that the people who gave us the disastrous EQC options 1 through 3 and going to hit a home run this time.

An even more intriguing silence was the  impending GAO report. As you recall, in the wake of the Maryland General Hospital problems, several congressmen asked the GAO to evaluate how CMS, CAP and JCAHO were doing their jobs. This has been a multi-year evaluation.

Well evidently, the GAO has finished the report and it was supposed to be released to the public in early June. Our JCAHO presenter, Kathy Steffens mentioned that a draft report had been delivered in April. CAP has already responded. JCAHO has also responded. But CMS asked for an extended period of time to respond.

Overall, there is an expectation that this GAO report is going to be a disappointment. It will ask for changes, but many of those changes will not be useful. It may reach some strange conclusions. And the odds that analytical quality is going to be improved by this report are very slim.
            

Westgard Workshops 2006, Part I

Originally posted on June 12, 2006
First of all, we want to thank all of our participants who came from all directions to learn and share. The most rewarding part of this continuing series is that some of our speakers this year were the participants only a few years ago. Clearly, we have seen people absorb the material, put it into action, and go even further with it. Lookingat the "class of 2006", it's going to be very interesting to see who emerges as the new leaders and teachers.

Here are some quick pictures of some of the class:

We had a fantastic turnout, our biggest attendance ever:

Below, Dr. Callum Fraser and Dr. Westgard talk with participants during a break:

We also want to sincerely thank all of our speakers. They, too, came from afar to present and enrich the Westgard Workshops. A special thank you goes to Callum Fraser, who came from Scotland to discuss the role of Biologic Variation in Quality Design and Planning. Probably the most illuminating discussion on the topic this year. We also thank Bio-Rad, Inc. for supporting Dr. Fraser's travel and accomodation.

Dr. Fraser's work on Biologic Variation contains some serious statistics, but the overarching message is simple: the data on Biologic Variation can quickly determine the needed performance of laboratory methods. With the extensive databank compiled by Ricos et al., and calculator tools easily available, all you have to do is plug a few numbers in and click a button. It's that easy to figure out the clinical usefulness of current methods, as well as the performance needed for the next generation of methods.

I'll add more comments on the workshops throughout this week. Stay tuned.