2001: Year of the Odyssey

James O. Westgard, PhD, FACB

An updated version of this essay appears on the Nothing but the Truth about Quality book.

This isn't the first nor probably the last article to compare this year to the landmark film 2001: A Space Odyssey. Over 32 years ago, Stanley Kubrick and Arthur C. Clarke predicted a world of routine space travel, giant computers, and vast possibility. Has our 2001 met these expectations -- in the laboratory? Dr.Westgard muses on what laboratory professionals thought back in 1968 and how things have "changed" since then.

January 2001

It's 2001, the official start of the new millennium. I'm not the first one to tell you that it's also the same year as Stanley Kubrick's film 2001: A Space Odyssey. The seminal film (and novel by Arthur C. Clarke) came out in 1968 and had an extraordinary vision of the year 2001. More than 32 years ago, Kubrick and Clarke predicted:

Space travel would be so commonplace it would be run by traditional airlines like Pan Am.
Space Stations would be large and numerous manned bases would exist on the moon.
Computers would become so powerful, so advanced, that they could reason, conspire, and even have nervous breakdowns.

In our year 2001, things have not quite fulfilled expectations:

We have a space station (just barely) but space travel is not commonplace, indeed is a rare event and a contentious political issue.
We have not returned to the Moon since the Apollo landings. Few people in 1968, in the heat of the US Space Program, would have believed that once we reached the Moon, we would turn our back on it. But we did.
Computers have indeed grown quite powerful, complex, and widespread, but true artificial intelligence has not been achieved. (Some might say that the propensity of some computers to crash at critical moments might qualify as nervous breakdowns, but that's not the problem the film predicted.)

A lot of the projections about where we were going to be didn't turn out to be true. And I thought at this moment, it might be good to look back to 1968 from a laboratory perspective: where did we think the laboratory professions were going to go, and where did we actually end up in our year 2001?

I have to admit that in 1968 I was too busy to pay any attention to Clarke's book or Kubrick's film. I had just finished graduate school at the University of Wisconsin in January 1968 and was beginning my first job as a Clinical Chemist at the University of Wisconsin Hospital. I finished my studies at the end of the first semester and needed a temporary job while my wife completed her teaching year in the Madison Public School system.

Having been trained to do research, I never doubted I had that capability. But, I didn't know whether or not I had the skills to do practical and useful work. To me, that was the biggest challenge and the skill I had to demonstrate to myself. The University reminded me that I also had to demonstrate academic excellence and my boss, Dr. Frank Larson, who was Director of the Clinical Laboratories, told me that I should "write down some of the things" I was doing and learning. To that end, I began to write about method evaluation and quality control.

I will also admit that I had no intention of staying at the University for these thirty-some years. It just happened that the clinical laboratory was the ideal workplace to apply my training in analytical chemistry, the work was truly satisfying, and very challenging.

Laboratory 1968

I began as a Clinical Chemist assisting Dr. Merle Evenson who was the Director of the Clinical Chemistry Laboratory. The first wave of laboratory automation was in progress - Technicon AutoAnalyzers and multichannel systems were being installed for as many of the tests as possible. Dr. Phil Hicks was developing one of the first computer information systems in our laboratory, therefore we were one of the few laboratories that had online data acquisition. It was a new world of automation and computerization!

Clinical laboratories were at the beginning of a long period of growth and development, but it was very difficult to maintain staffing - not unlike the period we are entering today. What differed was that we had no problem getting the hospital administration to provide us with new positions. The problem was that we could never keep our positions fully staffed. There was a shortage of Medical Technologists and a high turnover in staff.

Emergency medicine was beginning to develop. Physicians who served in the Vietnam War were beginning to provide more aggressive emergency room treatments. The first blood gas instruments appeared, making it possible to provide critical laboratory tests that were of much value in emergency services. Micro analyses were also improving, which increased the demand for services for pediatrics and neonates. Renal dialysis and kidney transplantation were becoming significant services at our hospital. All of these led to increased demand for stat tests and around the clock service.

Up till this time, most after-hours service was provided by a few senior technologists, usually the laboratory supervisors. As the demand for after-hours chemistry tests grew, we established "call programs" to provide 24 hour service. Within another year or two, we had to establish full-time staffing for 24 hour service in clinical chemistry. Night positions were, of course, not very desirable hours for most people, and we had to staff those positions with the least senior personnel, usually new Medical Technologists and Medical Laboratory Technicians.

Quality issues

Given the changes in technology, the increased demands for services, and the difficulty in maintaining adequate staffing, the quality of laboratory tests was a big concern. Dr. Roy Barnett, a clinical pathologist at Norwalk Hospital, was the leading authority on quality management in laboratory testing. Barnett published his first recommendations on the medical significance of laboratory tests in 1968 [1] and a landmark paper on method validation in 1970 [2]. Quantitative techniques for analytical quality management were just beginning to be used.

My first job assignment was to evaluate the performance of a new Technicon multichannel analyzer. This was the beginning of a long learning experience about experimental approaches and statistical techniques for method validation studies [3,4]. Of course, once a method was evaluated and implemented, then statistical QC became a big concern. My life's work lay before me, though I didn't know it at the time.

Quality management principles

By 1974, I had enough practice experience and common sense to formulate the management approach that I thought was needed to maintain a high-quality service laboratory. Working with Marion Hunt, who was the Chief Technologist in the Clinical Chemistry laboratory, we wrote the paper that has defined my life's work. That paper, Quality is everyone's job [5], described the philosophy and approach to quality management that has guided me throughout my career. The paper is not well-known because it was published in a "throw-away" journal. Some of the language and terms are old-fashioned and out-of-date, but the fundamental principles that were outlined then are as valid today as they were thirty years ago:

To achieve quality, it is necessary to view quality management as a system that permeates all activities in the laboratory.

Commit to Quality as a management strategy:

Management's commitment to quality is central to the whole system.

Management must communicate the goals to the analysts and must be willing to share the responsibilities with the analysts.

If Management encourages quality, well-qualified and conscientious people will provide quality, in spite of obstacles that may confront them.

Put everyone to work on Quality:

The laboratory should permit each analyst to contribute to the development and maintenance of the quality system; one approach is specific method or instrument responsibilities.

It is essential that each technologist understand the QC system and that its purpose is to help him/her perform their work.

Each technologist must understand that the most important response to an "out-of-control" indicator is to question the validity of the laboratory results.

Focus on processes and improvement:

Careful selection of methodology and instrument systems and proper standardization is essential to institute methods, or processes, which have a chance of providing reliable results.

When a problem is identified, a solution must be implemented to achieve acceptable performance.

Institute on-the-job education and training:

Through in-service training and careful and periodic evaluation of personnel, the laboratory can maintain the capabilities of each analyst.

In-service training is the mechanism for providing the transfer of new methods from method validation to routine operation.

The inservice training program provides a mechanism for change that can be used to institutionalize process improvements.

Laboratory 2001

Laboratories today are again in the midst of many changes. Mergers at all levels have had a profound effect on how the laboratory performs. There has been an explosion of new devices, methods and instruments. Just when the skills needed in the laboratory are becoming more complex, a severe shortage of qualified medical technologists has occurred. A new focus on profit and bottom lines has made quality seem like an "extra" instead of a fundamental. All this and much, much more has happened.

Have we outgrown the quality management principles of 1968? Not by a long shot. 2001 is here, but many of the problems are the same as before - changing technology, increasing demands for testing, shortage of skilled analysts, increasing concerns about quality. The quality principles of "old" are embodied in today's quality management approaches: Total Quality Management, Continuous Quality Improvement, and Six Sigma Quality Management. Our year 2001 still faces the same problems and issues as the laboratory faced back in 1968. In many ways, the problems have grown more complex - additional problem-solving mechanisms and tools are needed.

Perhaps the main difference between 1968 and 2001 is that while quality is still a concern in the laboratory, the core reason behind the concern is different. Back in 1968, the tools and techniques to assure quality were still being developed. Here in 2001, we assume that we've dealt with all that quality stuff and can move on. The US government passed the CLIA regulations - now endless forms, records, and documentation are required for "compliance" with those regulations, so quality must be okay, right? Have you ever met a salesperson who told you that the quality of the latest control/method/instrument was bad? And salespeople are experts in quality, so they should know.

Unfortunately, the truth is that compliance to minimum regulations does not assure quality. Too often, laboratories in 2001 ignore quality because they have to satisfy a profit margin, because they don't have the skills to know the difference between good or bad quality is, or simply because a staffing shortage prevents us from dealing with the problem.

Like the moon, we have turned our back on quality.

What we're doing about it!

One might be tempted to give up on quality altogether - if we can't get it right after 32 years of trying, perhaps it should be abandoned. But every crisis is also an opportunity. We are not helpless to prevent poor quality. Any action we take is a step in the right direction

To that end, in 2001 Westgard QC will bring you the practical tools and training to implement Six-Sigma quality design and control in your laboratories. These are special resources that can be applied to any laboratory and any analytical testing process, even those in other industries. These resources include quantitative tools that are not available in standard off-the-shelf Six-Sigma training programs, therefore they will supplement any Six Sigma or Total Quality Management program.

As part of these efforts, we are reorganizing the Westgard.com website to provide better Internet services. These will include:

Online store for purchasing training materials;

Direct registration for training courses;

A special members-only section with interactive Internet tools and software downloads.

We will also bring you new educational materials, including:

Six-Sigma Quality Design and Control manual

Current Issues in Analytical Quality Management manual

Online course on Basic Planning for Quality

Live workshop on Six-Sigma Quality Design and Control

And we have new, advanced computer tools available right now - the new EZ Rules version of our Validator technology for automatic selection of statistical QC procedures.

We invite you to join us in 2001: A QC Odyssey. Let us participate in the fight for quality. Let us share the journey.

References

Barnett RN. Medical significance of laboratory results. Am J Clin Pathol 1968;50:671-676.

Barnett RN, Youden WJ. A revised scheme for the comparison of quantiative methods. Am J Clin Pathol 1970;54:454-462.

Westgard JO, Hunt MR. Use and interpretation of common statistical tests in method comparison studies. Clin Chem 1973;19:49-57.

Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem 1974;20:825-833.

Westgard JO, Hunt MR. Achieving quality is everyone's job. Laboratory Medicine 1974;12:16-20.

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.

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