Tools, Technologies and Training for Healthcare Laboratories

Part I. Cracks in the Healthcare Quality System?

May 2004

Dr. Westgard comments on the reports involving Maryland General Hospital and laboratory errors. The first in a series of articles on this story.

Hear, Hear, Hear! Hearings on untruth and unquality!
Part I. Cracks in the Healthcare Quality System?

May 2004

It has been some time since I’ve written about quality in the news. My excuses are teaching, grandchildren, traveling, grandchildren, completing the CLIA Final Rules book, grandchildren, and also finishing another book titled “Nothing but the Truth about Quality.” The “truth” book contains many essays from this website, organized around the gold standard of evidence, i.e., the importance of “the truth, the whole truth, and nothing but the truth.” Quality and truth have much in common. The ideas are simple, but their evaluation in the real world is difficult.

This past week, the New York Times restated the news about several of their earlier articles on weapons of mass destruction, acknowledging that they did not adequately vet and check their sources. In the very same week, Ahmad Chalabi was exposed as an unreliable source of much of the intelligence information about the weapons of mass destruction. Turns out he was one of the sources for the New York Times stories as well as the Defense Department’s intelligence on WMD. Then, still within the same week, the General in charge in Iraq stepped down, NOT because of anything to do with the treatment of prisoners in Abu Graib, for which he testified in a hearing on Capital Hill that he was responsible but not to blame. This should be enough untruth to challenge every American to take politics more seriously.

Last month on Capital Hill there was also testimony before the Subcommittee on Criminal Justice (of the Committee on Government Reform) about “Ensuring accuracy and accountability in laboratory testing: Does the experience of Maryland General Hospital expose cracks in the system?” I suppose we should be thankful that all of the other bad news overshadows the bad news about quality in laboratories and healthcare. On the other hand, we might also consider that all of these events are connected to the lack of truth and quality in political decisions that lead to government policies and regulations.

Bad apples or bad apple trees?

I’m particularly dismayed that the theory of a few bad apples has been advanced as the cause of many of our current problems. Anyone with any experience in management, and particularly quality management, should know that this theory is false. In fact, it is one of the fundamental principles of quality management that problems are caused by poor processes, not people. Poor processes let bad things happen. The people involved in the process are victims as much as the products, patients, and prisoners. Poor managers blame the people, even though the managers themselves have designed the processes and also are the only ones who have the power to make changes that will prevent the problems. There certainly are some badly diseased apple trees that drop their apples, let them spoil, then blame the apples for spoiling themselves.

The name of that disease is “poor management.” The structure of the management tree has decayed. Yes, those same people who make the big money are the ones who are responsible for many of the problems in Corporate America, Government America, and Healthcare America. Many cases of gross mismanagement in corporate America have filled the news the last few years. The cases of gross mismanagement in Government America are filling the news today. The cases of gross mismanagement in Healthcare America are beginning and can be expected to fill the news in the years ahead.

Principles of good management

I submit that the principles of quality management are the most important part of “good management.” The reason is that the lack of quality is a major cause for losing marketshare and going out-of-business. Others may argue that financials are more important than quality, but Japanese industry pretty much destroyed that argument in the 1980 and 90s. Remember the principles espoused by Deming: improved quality leads to improved productivity (by reduction of waste and rework) which leads to improved financials. Thus, quality management is good management for profitability as well.

In the book on Curing Health Care [1], the basic principles of quality management are given as follows:

  1. Productive work is accomplished through processes.
  2. Sound customer-supplier relationships are absolutely necessary for sound quality management.
  3. The main source of quality defects is problems in the process.
  4. Poor quality is costly.
  5. Understanding the variability of the process is a key to improving quality.
  6. Quality control should focus on the most vital processes.
  7. The modern approach to quality is thoroughly grounded in scientific and statistical thinking.
  8. Total employee involvement is critical.
  9. New organizational structures can help achieve quality improvement.
  10. Quality management employs three basic, closely interrelated activities: quality planning, quality control, and quality improvement.

Note particularly items 1, 3, and 5. Work is accomplished through processes, defects are caused by problems in the process, and reduction of those defects, i.e., quality improvement, depends on understanding and reducing the variability in the processes. Employee involvement is critical (item 8), but the employee doesn’t design, implement, or manage the processes. Presidents, CEOs, department heads, directors, supervisors, and managers are the people who have the power, authority, and responsibility to define, modify, and improve the processes. The employees who provide the first line of defense often have knowledge of what is going wrong and their involvement is critical to make improvements in the process.

I also want to point out that this book was published in 1990, prior to the more recent Institute of Medicine books that call attention to the severity of quality problems in healthcare [2,3]. These management principles are well-known, even in healthcare. And they have been derived from earlier practices in manufacturing industry, thus they are even more well-known in Corporate America than Healthcare America. Given that many of our current government officials have come from Corporate America, it follows that these principles should also be well-known in Government America.

Principles vs politics in the laboratory – a case study is unfolding

We now have an opportunity to watch the war of principles vs politics unfold in a battlefield close to home – an American hospital laboratory. Please forgive my rhetoric, but it seems to take a war to arouse our interests. Maybe we need a war against unquality in laboratory testing. If so, the first battle is being waged right now in the hearings on Capital Hill. The first hearing was held on May 18, 2004, and a second hearing is scheduled for mid-June.

The first hearing includes testimony from the FDA describing the classification and approval of medical devices and their introduction into the field, CMS describing the CLIA regulations for field laboratories, an instrument manufacturer describing the monitoring and maintenance of systems in the field, JCAHO describing the inspection and accreditation of a hospital, CAP describing the inspection and accreditation of a laboratory, a president and CEO of a healthcare systems describing the quality management in a multi-site healthcare system, a member of the board of trustees of a hospital describing the mission and community service of the hospital, and two clinical laboratory analysts describing the working conditions and environment in the laboratory.

Rather than comment on the evidence presented so far, I will wait until after the second hearing. However, I will refer you to an earlier discussionQuality is Job One when the Rubber meets the Road [4] that considers patient safety and the many cracks in our fragmented quality system in healthcare. Don’t say we couldn’t predict that this would happen in spite of FDA, CMS, JCAHO, CAP, ISO, etc. I think “cracks” underestimates the problems; “canyons” comes to my mind!

CLIA 2005?

One wonders if this is the start of another round of laboratory regulations. Given that CLIA is finally final after some 15 years in the making, maybe this is the first public evidence that CLIA doesn’t really work. Remember that it was cholesterol testing and PAP smears that got CLIA going many years ago. Those reports appeared in the Wall Street Journal, rather than the Baltimore Sun, but otherwise this has an all too familiar feel. This might be the start of something new!


  1. Berwick DM, Godfrey AB, Roessner J. Curing Health Care: New strategies for quality improvement. Jossey-Bass Publishers, San Francisco, 1990, Chapter 3, pp 29-45.
  2. Institute of Medicine. To Err is Human: Building a safer health system. National Academy Press, Washington, DC, 2000.
  3. Institute of Medicine. Crossing the Quality Chasm: A new health system for the 21st century. National Academy Press, Washington, DC, 2001.
  4. Westgard JO. Nothing but the Truth about Quality: Essays on quality management in the healthcare laboratory. Westgard QC, Inc., Madison, WI, 2004, Chapter 22.

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.