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Brett Trusko, Ph.D. and H. James Harrington

Brett Trusko, Ph.D. and H. James Harrington’s default image

FDA Compliance

The Prescription for Health Care Excellence

Take Six Sigma as needed

Published: Tuesday, April 25, 2006 - 22:00

According to the Institute of Medicine, there are approximately 100,000 people per year killed in the Unites States because of medical errors. There are 100,000 families in despair because they have lost a loved one too soon. This also means that 100,000 medical professionals are losing sleep, worried about what they should have done differently, or whether they’ll be able to continue practicing medicine. Looking at this differently, the spending on homeland security, international affairs and defense since Sept. 11 has risen by some estimates as much as $100 billion per year—$33 million for every person killed that day. Although we can’t accurately estimate how many dollars are spent on health care quality, we know that the federal government is spending $100 million on health care information technology (IT) and at least that much on other quality initiatives. Even if we’re conservative in our estimate and figure that $1 billion is spent on health care quality, the per capita spending is only $10,000 per death. The 9/11 deaths were tragic and comparing terrorism to health care delivery may not be fair, but it’s valid if you’re one of the family members whose loved ones died because of a medical error.

Consider the following shocking stories: Patricia Ann Hottois, 53, died after an abdominal pad was left in her after surgery at Maricopa Medical Center in Phoenix in 2003; two dialysis patients at Foothill Medical Centre in Calgary, Alberta, died when they were given potassium chloride instead of sodium chloride in 2004; Tawnya Brown died at Inova Fairfax Hospital in Falls Church, Virginia, in 2003 when she was given two pints of A-negative blood although she was O-positive; and a 2-year-old boy died at a large Minnesota hospital after being given the wrong dose of Heparin after a liver transplant because the nurse misread the log. These are only four misfortunate deaths, and there are 99,996 more who are most likely forgotten by everyone except the families and, in many cases, the court system and malpractice insurers. Perhaps the most unfortunate thing about all this is that the errors are generally not the fault of health care professionals, but that of poorly designed processes, ineffective information systems and a bureaucratic mess caused by arcane laws and the need to practice defensive medicine. Patients and health care professionals deserve better.

What’s the answer?
Regardless of which statistic strikes a chord with you, the industrialized world is facing a triad of problems—an aging population, a health care worker shortage and a situation where health care expenses are growing at double digits—all of which are causing the United States to become less competitive in the world market. Furthermore, these health care costs are becoming a greater challenge for a government whose tax base is declining as a direct result of a general decline in the working-age population and manufacturing facilities.

For the purposes of this article, we accept that the number of deaths and the amount of quality in the health care system are directly related. If we improve quality, we will reduce the number of deaths due to medical mistakes. Over the long term, higher quality also equates to cheaper health care. Additionally, higher quality, contrary to the common perception, also leads to a need for fewer medical professionals as we eliminate the need for redundancy and inspection. It’s time to measure health care failures in mortality per million, not mortality per thousand. Given that we’re talking about health care, mortality by error should require measurement per billion opportunities instead of per million.

Studies indicate that service industries have an error rate of 159,000 to 308,000 per million opportunities. In statistical terms this turns out to be the 2.0 to 2.5 sigma level. For example, the process for treating depression is estimated to be running at 308,538 errors per million opportunities, or at the 2 sigma level. (Sigma, shown as the Greek letter , is commonly used as a measurement of the variation around the average of any process. Also known as the standard deviation, 1 represents 34.134 percent of the data points under a normal curve.)

Although process-capability techniques have been used extensively in manufacturing for over 50 years, a breakthrough occurred when Motorola applied them to business-support functions as a logical extension of its manufacturing initiatives. The results were improvements of 10 to 100 times in Motorola’s business process in as short a period as two years. When Motorola won the Malcolm Baldrige National Quality Award in the late 1980s, it credited the Six Sigma program as the primary driver of its improvement. During the first part of the 1990s, Six Sigma continued at Motorola and spread slowly into other organizations. In the mid-1990s General Electric Co. latched on to the concept and committed millions of dollars to implementing the program throughout the organization. GE’s program expanded from 200 projects in 1995 to 6,000 projects in 1997, which resulted in more than $320 million in savings, all attributed to Six Sigma. In 1998, GE estimated that its savings were about $750 million.

Six Sigma projects are designed to reduce error rates to a maximum of 3.44 errors per million exposures (or opportunities) through the use of statistical-analysis techniques, problem solving and quality principles. The typical health care organization has error rates between 67,000 and 309,000 (three sigma and two sigma) per million opportunities.

More important than the measurement of error rates is the methodology behind Six Sigma. The Six Sigma methodology forces hospitals to measure those categories that are important to the business of health care: quality, mortality, customer satisfaction and employee satisfaction, among others. If a hospital says that it’s a “patient-focused” organization, what does that mean? How does the institution measure patient focus? If it can’t be measured, then how do they know if they’re successful at it? Real-world experience shows that humans measure what they think is important and while hospitals do a wonderful job of measuring net income, they generally don’t do so well at measuring patient focus.

Many health care organizations have attempted process improvement over the past 20 years, and most of these efforts have ended in disappointment. The discipline of the Six Sigma approach to quality through process improvement (as opposed to isolated quality attempts such as inspection and post-mortem review of errors) is potentially the industry’s best opportunity to address lingering issues of quality and the resultant real costs that are added to any system when poor quality is the rule, rather than the exception.

Six Sigma applications
An ever-growing number of health care organizations are using Six Sigma to improve processes—from admitting to discharge and all of the administrative and clinical processes in between. This adoption is driven by several factors, including the need to improve an organization’s bottom line and to eliminate medical errors, as well as to position the health care industry for an imminent, global, consumer-centered health care revolution.

Health care providers once enjoyed a respect from their customers that few institutions in the world could match. Then came years of double-digit cost increases capped off by the National Institute of Health’s report that medical errors kill approximately 98,000 people per year in the United States. These mistakes can range from prescription errors to a failure to wash one’s hands. Many health care consumers began to question why increasing costs didn’t equate to improved quality. Accordingly, the health care industry finds itself at a crossroads: It can continue on the current path, which surely will lead to disaster, or it can choose the other route, which may bring about redemption.

From a historical perspective, early efforts to use Six Sigma in health care were based on either 100-percent inspection or Phil Crosby’s zero defects (View “Zero Defects vs. Six Sigma” article here). Zero defects is an inspirational way of explaining to employees the notion that everything should be done right the first time, that there should be no failures or defects in the work process. In the health care world, a defect can be as small as an unpaid bill or so serious as to result in the death of a patient. Probably more critical than in any other industry, zero defects should be the order of the day in a patient encounter.

Zero defects, however, is a difficult concept for employees to comprehend, because the reality of the business is that zero defects can never be achieved.

To make Six Sigma more personal, consider the case of a physician who performs more than 1,000 surgical procedures with 1,000 opportunities for error per case. This is very challenging based on normal performance levels and requires a radical new design in the way operating rooms function.

If the typical surgical procedure contains 1,200 processing steps and each step has a short-term 4-sigma capability, (because the process inevitably drifts) the yield from the procedure over time would be approximately .05 percent. In other words, there’s a near-zero possibility of completing a single surgical procedure without committing an error.

Will Six Sigma work in health care?
The Six Sigma approach is in its infancy in the health care industry. It’s been applied to some extent to refine some hospitals’ business processes using reengineering or process-redesign methodologies. But, all in all, we won’t be successful in reducing patient errors by continuing to follow the quality efforts of the past.

Most health care providers have put into place some type of total quality management or continuous quality improvement program. Six Sigma will enhance these programs as it builds on their strengths and puts additional focus on measurement systems.

We recommend the following 10-step process to reach the six sigma level in a clinically intensive process:

  1. Identify your products. What service or product are you producing? In the case of an operating suite, it might be technically superior procedures.

  2. Identify customer requirements. Patients’ perceptions of error-free performance are based on all the little things that go on around them, and patients set the performance standard.

  3. Diagnose the frequency and source of errors. What’s the source of errors? In an emergency department, errors could come from any number of places, including supply carts or ineffective ambulance routing, leading to overcrowded waiting rooms.

  4. Design the process. How can the process enablers be put together to provide the best value solution? In the emergency room, perhaps there are mechanisms that can help to avoid overcrowding.

  5. Develop a simulation model. This is used to project the processes’ performance characteristics and determine if the process will meet the customer’s error-free needs. Try a new scheduling system.

  6. Error-proof the process. How can the process be changed to eliminate potential errors? In the operating suite, this might include a new flow of personnel or redesigning procedure packs.

  7. Install internal and external control points and measurements. How can you detect trends before they become errors?

  8. Install the new process. How do you get users to embrace the new process?

  9. Measure performance. Does the process meet the Six Sigma requirements? If not, how does the process need to be adjusted to do so?

  10. Improve continuously. How can the process’s effectiveness, efficiency and adaptability be improved?

Six Sigma applied to health care will lead to shorter hospital stays, improved customer satisfaction, reduced time waiting to enter the health care unit, reduced inventory, and increased efficiency in the billing and collection system. Even for those health care providers that claim they can’t afford it, there are critical processes that can be addressed while noncritical processes are ignored in the name of economics. For example, the airline industry operates at an almost unheard of 7+ sigma level for getting passengers to their destination, while baggage delivery is at some level below three. We may not get some things right, but delivering error-free health care should be an international priority.


About The Author

Brett Trusko, Ph.D. and H. James Harrington’s default image

Brett Trusko, Ph.D. and H. James Harrington

Brett Trusko, Ph.D., has a doctorate in business administration, an MBA in innovation management and more than 20 years of experience in information-technology standards, process improvement, finance, information systems, project management and interim executive management. He’s also a certified public accountant and an innovator in information technology, new-product development and corporate entrepreneurialism. Trusko is a frequent lecturer in topics ranging from technology and policy to IT strategy and product development. He’s now a senior manager with Harrington Institute.H. James Harrington is CEO of the Harrington Institute Inc. and chairman of the board of Harrington Group. He has more than 55 years of experience as a quality professional and is the author of 22 books.