The Westgard Rules

Errors in our thoughts on Laboratory Error Rates?

Posted by Sten Westgard, MS

A recent abstract from the 2009 IFCC/EFCC (Euromedlab) caught my eye:

Quality Indicators for Laboratory Process; assessment in the Trento Department of Laboratory Medicine.
I Caola, C Pellegrini, N Bergamo, E Saurini, P Caciagli.
CCLM 2009

Examining the quality records of five laboratories, they applied a set of Quality Indicators from the IFCC. Errors were tracked and tabulated. The results are quite interesting.

Q&A: The independence of vendors for QC and EQA/PT?

Posted by Sten Westgard, MS

A recent question came in from outside the US, regarding the choice of controls and EQA/PT provider. In such a case, there are often economies gained by choosing the same vendor for both control materials and EQA/PT materials. But the theory of quality control and assurance dictates that you should have independent checks on your processes. Indeed, in some countries, there are regulations which prevent control manufacturers from selling proficiency testing materials for precisely that reason.

This is a difficult issue, one that epitomizes the struggle between efficiency (cost) and safety (quality). 

More after the fold...

STT-Consulting: Worth the Trip

Posted by Sten Westgard, MS

I have been meaning to post this for some time. Our good friend and colleagues, Dietmar

Stöckl and Linda Thienpont, started their own website in the latter part of 2008: STT-Consulting

What's New: June 2009

Posted by Sten Westgard, MS

We've had a lot of new material this month!

ESSAY: EQC = Eliminated QC

A recent exchange of emails between POCT users reveals the true effect of reducing QC frequency with EQC options.

http://www.westgard.com/essay128.htm

NEW DATABASE: Within-subject biological variation in disease: collated data and clinical consquences

Dr. Carmen Ricos and her colleagues have generously allowed us to post a new database on Biologic Variation within subjects with disease. The previous databases have relied on data from healthy patients. See how the variation changes when you examine patients with different disease states.

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

INTERVIEW: Dr. Carmen Ricos

In addition to letting us post another one of her databases, Dr. Carmen Ricos agreed to answer a few questions about the work, the results, and the meaning of all this biologic variation.

http://www.westgard.com/interview11.htm

SIGMA ANALYSIS: A New Mid-Volume Laboratory Analyzer

We take a look at data from an abstract that will be presented at the 2009 AACC/ASCLS/CSCC conference in Chicago. Just because you buy a new chemistry instrument, does that guarantee you'll get world class quality methods?

http://www.westgard.com/qcapp58.htm

REMINDER: CHANGE IS COMING TO WESTGARD WEB

We wanted to give you a heads-up on future changes that will be made to the layout and operation of Westgard Web. Don't Panic.

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

Reminder NEW ONLINE COURSE: QUALITY MANAGEMENT AND DESIGN FOR ANALYTICAL SYSTEMS

The new online course introduces you to the Planning and Design techniques that are part of the systems approach to analytical quality management.  In six lessons, participants review current guidelines for quality, learn to use QC Design tools, customize their procedures, and achieve the quality required by their tests. This course includes a short video lecture by Dr. Westgard.

As a bonus, register this month with coupon NEWIQMD and you'll save 25% off the cost of registration
 (must use coupon at http://www.westgardqc.com )

http://westgard.org/index.pl?iid=27322

Q&A: QC with a new control lot; manufacturer mean

Posted by Sten Westgard, MS

Some recent questions we got via email:

"When a new lot number of control was started in a machine, the insert sheet range will be followed until 20 or 30 days then our own range will be settled. After doing this some of the tests run during this period become outside the settled range. Is this accepted?"

"Sometimes our own range is outside the insert sheet range e.g. the insert sheet range is 20-30 and our own range is 18-25. is this accepted or we have to be inside the insert sheet range"

The answers, after the fold...

Guest Editor: MLO at 40 years

Posted by Sten Westgard, MS

Medical Laboratory Observer is celebrating its 40th year of publication. As part of the festivities, they asked Dr. Westgard to pen a guest editorial. Here's the link:

Quality Management: 40 years of rules and regs, training and education
http://www.mlo-online.com/features/2009_june/0609_editor.aspx

Congratulations to MLO on four decades of service.

Come See Us at Booth 1826

Posted by Sten Westgard, MS

 That time of year is approaching again...

Westgard QC, Inc., will attend the 2009 AACC/ASCLS/CSCC meeting in Chicago, Illinois. We will be at BOOTH 1826.

Among other things, we will be demonstrating software as well as our new online courses at http://www.westgard.org We will be offering registration specials for training, as well as coupons for the books and software.

We will also be holding the annual "Westgard Wear" raffle, the only opportunity to win such items as a "Westgard Rules" baseball cap, shirt, or messenger bag. These items are not sold in stores (no store would be willing to sell them). Nor will these items be understood by the general public if you wear them. But for those seeking rare and obscure laboratory apparel, it doesn't get more rare and obscure than this.

[I think this year we will also find a way to let people who aren't attending the conference participate in the raffle, too. Stay tuned to the blog for those details.]

This, of course, is not in compliance with the AdvaMed's new ethics policy. (We will still be giving away pens at the booth, too.) We aren't worried that these small gifts will exert too much influence on your purchasing decisions and behavior; there isn't that much money to be made in quality in the first place.

Seeking Laboratory Best Practices

Posted by Sten Westgard, MS

Paul Epner, who helped start the Labs are Vital initiative, asked us to put out the word for him on an important issue.

Paul is working on a project with Battelle Memorial Institute (Battelle) to identify evidence-based "best practices" in laboratory medicine, particularly in these three areas:

• Reducing patient specimen identification errors
• Timely, accurate communication of critical laboratory test results
• Preventing blood culture contamination

If you have unpublished studies, or in-house data on these topics, we encourage you to contact Paul Epner: PEPner at chicagobooth dot edu (I'm spelling the email address here to cut down on Spam to Paul's account). Paul and Batelle are actively seeking new participants in this project. You can find out more at the http://www.futurelabmedicine.org

Battelle does this work as a subcontractor for the CDC, so this is important work and these results will be widely disseminated.

Best Practices for the Laboratory are also Vital.

What's New: May 2009

By Sten Westgard, MS

If you can read the dates, you know we're a little behind schedule this month - or last month.

In May, Between Dr. Westgard and myself ("a" Westgard), we visited Puerto Rico; Oslo; Kolding, Denmark; Hamilton, Ontario; and Barcelona, Spain. We were not in the office very much and did not keep up with our website posting duties. While we were able to put up new material, we fell behind in telling people about the new articles.

So here, in retrospect, are the new articles that appeared last month:

ESSAY: The Risk Management Process

Risk Management tools, techniques and terminology are headed for the laboratory. New standards and guidelines will make heavy use of these concepts in forthcoming recommendations for laboratory conduct. So what is Risk? And what exactly is Risk Management? Dr. Westgard explains some of the words and meanings of this new movement... 

http://www.westgard.com/essay127.htm

GUEST ESSAY: A MANUFACTURER'S PERSPECTIVE ON SIGMA-METRICS

Dr. Ian Giles, Director of Scientific Affairs for Sysmex America, shares their experiences with Sigma-metric analysis and its impact upon their operations and customer relations.

http://www.westgard.com/guest44.htm

NEW ONLINE COURSE: QUALITY MANAGEMENT AND DESIGN FOR ANALYTICAL SYSTEMS

The new online course introduces you to the Planning and Design techniques that are part of the systems approach to analytical quality management. In six lessons, participants review current guidelines for quality, learn to use QC Design tools, customize their procedures, and achieve the quality required by their tests. This course includes a short video lecture by Dr. Westgard.

As a bonus, register this month with coupon NEWQMD and you'll save 25% off the cost of registration
 (must use coupon at http://www.westgardqc.com )

http://westgard.org/index.pl?iid=27322

Thanks for your patience and continued patronage of the website.

Lots more in store for June!

Links to Canada

The Hamilton, Ontario, AQC Workshop

By James O. Westgard, PhD

Pictured with us are Brenda Rafter-Tadgell, Cathie McCallum,
Dr. Westgard, Joan Weppler, Andrea Tjahja, Sten Westgard and Dr. Edward Young.
These hosts worked very hard to arrange for a spectacular day.

On May 22, 2009, we had the pleasure of presenting a workshop on “Planning Analytical QC Systems” in Hamilton, Ontario.  Sponsored by the Hamilton Regional Laboratory Medicine Program, 200+ laboratory analysts greeted us with great Canadian hospitality. 

We were met at the airport by a stretch limo that was truly impressive. And unusual, since the normal business travel we do does not involve any kind of limo, much less stretch. We only wished our wives had been along so they could have been suitably impressed.

This is our first workshop on “Planning Analytical QC Systems” that begins to address the application of risk management for optimizing laboratory QC plans.  We intend to further develop this theme and related educational materials to address the training needs for the new CLSI EP22 and EP23 guidelines due to be published later this year.  Our plan is to provide practical guidance in tune with our recent book “Assuring the Right Quality Right: Good Laboratory Practices for Verifying the Attainment of the Intended Quality of Test Results.”

For those of you who follow Westgard Web, the introduction to our approach to developing Analytical QC Plans can be found in the following recent postings:

• “First do no harm: A safety net to catch analytical errors.” www.westgard.com/essay125.htm
• “The Risk Management Process.”  www.westgard.com/essay127.htm

Our approach builds on the fundamentals of QC Design and Planning, which are now available in a new online course on “Quality Management and Design of Analytical Systems.”  This new course is based on the “Right Quality Right” book and introduces the concepts and tools that are needed to customize or optimize QC procedures for the quality required by a test and the precision and bias observed for a method. 

Our Hamilton workshop covered some of this material, with particular emphasis on tools such as the Method Decision Chart, Sigma-Metrics QC Selection Tool, and Normalized OPSpecs Charts.  You can find support for these tools on our website, including the following descriptions and downloads:

• “Update on QC design tools.” www.westgard.com/essay94.htm
• “Adopting the OPSpecs chart as your planning tool.” www.westgard.com/lesson54.htm
• “Implementing a manual process using normalized OPSpecs charts. www.westgard.com/lesson56.htm
• Sigma-metrics worksheet and presentation pdf download
• Normalized OPSpecs charts pdf download

Thanks again to our hosts and to all those who attended the workshop.