"Housekeeping"

A discussion of Westgard QC and its new offerings - more online courses, more downloads, more information, and the ability to order our products directly through the website. How do we balance our educational offerings with our commercial ones? Dr. Westgard talks about this delicate juggling act and invites your comments.

• The Cost of QC Planning
• The QC Validator Idea
• The Upside
• The Downside
• Our Intentions
• The Question of Objectivity
• References

Phil Crosby's book "Quality is Free" [1] was very influential in selling the concepts and ideas of quality management to business and industry. We used Crosby's book plus his video "The Quality Man" to introduce TQM in the laboratory at University of Wisconsin Hospital in the mid 80s. As we started to implement TQM, it was obvious that it was costing us a lot of time and effort to make the improvements necessary to achieve the quality required by our users and customers.

Quality may be free once the necessary quality has been achieved, but the process of improving quality does cost money, particularly the time and effort involved in training for process improvement, making improvements in existing processes, and implementing new quality processes.

The Cost of QC Planning

It has to cost money to implement a QC planning process to improve analytical quality management because it's a new process for most laboratories. It's like implementing any new method in a laboratory. You have the choice of preparing everything from scratch, which minimizes reagent and supply costs while maximizing labor cost, or you can buy a reagent kit or an instrument system, which maximizes reagent and supply costs while minimizing labor costs. You can implement a QC planning process by developing power function graphs and preparing OPSpecs charts from scratch, or you can use a planning kit such as the OPSpecs Manual, or you can use techology such as the QC Validator program. The point is that it costs money, time, and effort anyway you do it.

To keep the cost low, we developed the ability deliver our QC Validator software over the internet. To be perfectly clear, I should say we are now "selling" software over the internet. One advantage of the internet is that the program is available to you when you decide you need it, without any cost or delay for shipment.

I view this as a very satisfying accomplishment and the culmination of a lot of work - taking the theory of quality control and quality-planning, developing practical tools that facilitate the application of that theory, developing the technology that makes those tools easily available, then delivering that technology to interested laboratorians anywhere in the world, along with the education and training necessary to support applications in their own laboratories. Others may view this as a conflict between quality and commerce, which is why I'm discussing what we're doing.

The QC Validator Idea

It all started because a reviewer of the early quality planning papers [3,4] pointed out that this theory would be of little practical value unless a software package could be developed "that would allow laboratorians to enter values for the quality requirements and have them translated into charts of operating specifications. This would be an extremely valuable contribution to the laboratory community." That started me thinking about a computer program that would do in minutes what it was taking me days to accomplish with electronic spreadsheets.

I'm not a programmer, so the problem for me was how to develop computer software to support quality-planning applications. The solution was to form WesTgard QC as a business entity to support development and application of QC planning tools, including software technology, hardcopy manuals, and training materials.

After a few years, we had the technology - QC Validator version 1.1 [5] - that accomplished what the reviewer recommended. The development of version 2.0 with automatic QC selection [6,7] takes the technology even further. And with the development of this website, we now are able to provide you with both versions of the computer program, as well as with educational materials and training to support QC planning in your own laboratory. As a professor, this achieves a major objective - taking one's research work and doing something useful with it. It's the whole cycle from development of new knowledge to application of that knowledge in the field. That's very satisfying!

The Upside

As the QC Validator program evolved, the OPSpecs chart became readily available and could be used for studying a variety of quality issues, such as

• the evaluation of clinical (non-statistical) control limits [8],
• the comparison of analytical and clinical quality requirements [9],
• the comparison of European and American recommendations for quality requirements [10],
• the design of QC procedures for immunoassay methods [11],
• the evaluation of method acceptance criteria and the development of a graphical method evaluation decision chart [12],
• the assessment of matrix effects of control materials on QC performance [13],
• the assessment of recommendations for "state of the art" method performance [14],
• the design of average of normals QC procedures [15],
• and the establishment of method specifications for imprecision and inaccuracy [16].

As the Wisconsin producer of Point Beer says, "it's not just for breakfast anymore." QC Validator's not just for selecting control rules anymore; it more properly should be consider a quality planning program that can be used to investigate a lot of quality issues.

The Downside

There is a downside, of course. My own role is changing because I'm no longer needed to do some of the things I used to do. There was a time when I was the expert in QC design and my recommendations on how QC should be done on different methods and instruments were valued by laboratories and manufacturers. Now they can get those same recommendations from a computer program that has my expertise embedded in the criteria and logic used for QC selection. I view that as an accomplishment because I believe that my real job is to establish processes to get things done. If I do a good job of that, I should no longer be needed to do those particular things. However, I think I'm still needed to establish new processes and better ways of doing things.

There's another downside that worries me more - it's the attitude that we can't provide a high quality educational website if we also sell products. Many people seem to think that it's a conflict of interest to try to do both. I believe we have to do both - provide quality training and education, as well as provide products to support and improve quality management. Theory without tools isn't enough. Tools without technology isn't enough. Technology without training isn't enough. That's why our mission at this website is "tools, technology, and training for quality management." [We'll continue to put the stuffy theory in the scientific literature, but we'll let you know where to find it.]

The fact is we have to develop a commercial component if we are to continue to bring you the educational materials and training courses. It takes money to support this website! In the first year, it' quickly became a full-time job for the webmaster to manage all the materials and support the educational and training efforts that are under development.

Our Intentions

We hope to make this website self- supporting and, therefore, a resource that will continue to serve you in the future. Educational and training materials will continue to be posted and available to you, free of charge. There is no requirement that you buy anything from us, however, we hope you will find some of our products of value and buy them for that reason.

We will start to formalize training courses that will be available for continuing education credit from various professional organizations. The Basic QC Practices courses is one example. If you want continuing education credits, an organized course of study, and a way to test your knowledge of the subject, you will have to pay for the course and credits.

We will also be organizing and packaging training courses for interested manufacturers and suppliers. These courses will have some customized materials for specific customers, therefore, they will be available only to customers with the appropriate identification. Further in the future, we expect to provide educational materials that will be used in college and university courses. Again, you will have to pay for those credits.

In short, if you want some recognition for what you're learning, you'll have to pay whoever grants the credits. If you want to learn for the love of learning, the materials are here and available to you for free.

Question of Objectivity

Will I try to sell the tools, technology, and training that I've developed as the best way of doing things? As they say in Minnesota, you bet! This is my life's work and I believe in what I'm doing.

However, there are several balancing factors that will keep me objective. One factor is that much of what I'm recommending has been documented in the scientific literature, which means it has been subjected to a peer review process. Believe me when I tell you I've had to answer a lot of questions, comments, and criticisms to get these papers about QC published in scientific journals. It's a lot more fun writing for this website where I have some freedom of expression, though the webmaster still gets on my case once in awhile.

You should also be aware that professional organizations review and approve any courses they offer for continuing education credits. "Commercial bias" is one of the important issues in such a review. Approval by a professional organization usually means that questions concerning commercial bias have been resolved. We had several discussions with AACC about this while the Quality Control Planning course was under review. And we made several changes due to that review, such as eliminating the need for the OPSpecs Manual as a source of OPSpecs charts and providing participants with a free educational version of the QC Validator program for generating OPSpecs charts as needed during the course.

Finally, there is the market itself. When better approaches, methods, tools, technology, and training come along, we will have to adapt, otherwise you won't visit our website and make use of what we're providing. Market forces will be a strong balancing factor and will force us to provide better training materials, courses, and products. Commerce doesn't conflict with quality, but actually is a strong driving force for improving quality and reducing costs. Providing the customer with improved quality at reduced cost is what Crosby was talking about when he said 'quality is free.'

References

1. Crosby PB. Quality is Free. New York: McGraw-Hill Book Co., 1979.
2. The Quality Man. Films Inc., 1213 Wilmette Ave., Wilmette, IL, 1982.
3. Westgard JO, Hytoft Petersen P, Wiebe DA. Laboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program (NCEP). Clin Chem 1991:37:656-661.
4. Westgard JO, Wiebe DA. Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing. Clin Chem 1991;37:1938-44.
5. Westgard JO. A program for assessing statistical control procedures. Med Lab Observ 1994;26(2): 55-60.
6. Westgard JO, Stein B, Westgard SA, Kennedy R. QC Validator 2.0: a computer program for automatic selection of statistical QC procedures in healthcare laboratories. Comput Method Program Biomed 1997;53:175-186.
7. Westgard JO, Stein B. An automatic process for selecting statistical QC procedures to assure clinical or analytical quality requirements. Clin Chem 1997;43:400-403.
8. Westgard JO, Quam EF, Barry PL. Establishing and evaluating QC acceptability criteria. Med Lab Observ 1994;26(2):22-26.
9. Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem 1994;40;1909-14.
10. Westgard JO, Seehafer JJ, Barry PL. European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by U.S. CLIA proficiency testing criteria. Clin Chem 1994;40:1228-32.
11. Mugan K, Carlson IH, Westgard JO. Planning QC procedures for immunoassays. J Clin Immunoassay 1994;17:216-22.
12. Westgard JO. A method evaluation decision chart (MEDx Chart) for judging method performance. Clin Lab Science. 1995;8:277-83.
13. Olafsdottir E, Westgard JO, Ehrmeyer SS, Fallon KD. Matrix effects on the performance and selection of QC procedures to monitor PO2 in blood gas measurements. Clin Chem 1996;42:392-6.
14. Westgard JO, Bawa N, Ross JW, Lawson NS. Laboratory precision performance: State of the art versus operating specifications that assure the analytical quality required by proficiency testing criteria. Arch Path Lab Med 1996;120:621-625.
15. Westgard JO, Smith FA, Mountain PJ, Boss S. Design and assessment of average of normals (AON) patient data algorithms to maximize run lengths for automatic process control. Clin Chem 1996;42:1683-1688.
16. Fallest-Strobl PC, Olafsdottir E, Wiebe DA, Westgard JO. Comparison of NCEP performance specifications for triglycerides, HDL, and LDL cholesterol with operating specifications based on NCEP clinical and analytical goals. Clin Chem 1997:43:2164-2168.