As startling as the 1999 report from the Institute of Medicine was – estimating that medical errors may cause 98,000 deaths annually – a new national study indicates the problem may actually be much worse. According to the report released in July by HealthGrades, a Denver-based healthcare ranking group, the number of hospital patients who die from preventable errors may be twice as high as previously estimated. This would put medical errors just behind heart disease and cancer as the third-leading cause of death in the United States.

The study, based on national Medicare records, found there were 195,000 deaths annually from 2000 to 2002, and estimated that such mistakes cost the United States an extra $19 billion. Such statistics underscore the compelling and continuing need for healthcare institutions to implement process improvement and change management methodologies such as Six Sigma.

In a column published in the Boston Globe on July 27, 2004, Dr. Samantha Collier, vice president of medical affairs at HealthGrades, commented on the implications: ”There is little evidence that patient safety has improved in the last five years. The equivalent of 390 jumbo jets full of people are dying each year due to likely preventable, in-hospital medical errors, making this one of the leading killers in the U.S.” Dr. Kenneth W. Kizer of the National Quality Forum, a Washington-based group that develops quality measurements for healthcare, noted in the same column that the HealthGrades’ tally would be even larger if researchers had included errors at nursing homes, physician offices and other outpatient settings.

Debate may continue about exact numbers and methods for calculating the scope of the problem, but there is general consensus that healthcare is simply not as safe and reliable as it should be. One notable exception would be anesthesiology. Improvements during the past decade have reduced the number of deaths attributed to anesthesia 25-fold from 1 in 10,000 anesthetics to 1 in 250,000 today.

Modeling High Reliability Organizations (HROs)

Without providing an in-depth analysis of HRO theory and all its complexities, a high reliability organization can be broadly defined as one that experiences fewer than normal accidents despite an inherently “risky” environment. The Institute for Healthcare Improvement proposed this definition of reliability in healthcare: “The measurable capability of a process, procedure or health service to perform its intended function in the required time under commonly occurring conditions.”

A study by researchers at the Veterans Administration Palo Alto Health Care System and the Stanford Center for Health Policy/Center for Primary Care and Outcomes Research sought to compare results of safety-climate surveys administered to hospital personnel with those completed by naval aviators – known for their superior safety record.

Results from a 2001 survey distributed to roughly 6,300 hospital personnel at 15 California hospitals, including physicians, nurses, technicians and senior management were compared with responses from 6,900 naval aviators who completed the Command Safety Assessment Survey between 1998 and 2001. The average rate of “problematic” responses was 5.6 percent for the aviators, 17.5 percent for all hospital personnel, and 20.9 percent for high-hazard hospital personnel.

The results of this comparative study were more striking than the team had anticipated. Obviously, providing health care to humans requires more flexibility and customization than flying airplanes, but there are still lessons that can be learned from aviation and other high reliability industries.

Prescription for Change

There is no “silver bullet” to completely eliminate risk, but there are steps that can be taken to create a culture of safety and develop a high reliability organization. Concentrating on controllable versus uncontrollable factors (without discounting the importance of addressing issues such as regulatory compliance, malpractice insurance and the lack of coverage for more than 40 million Americans), healthcare providers can benefit by adapting solutions that help to fill existing gaps and fixing problems within their own sphere of influence.

Based on the systemic deficiencies outlined by a number of industry experts and the factors identified as characterizing successful HROs, the following is offered as a preliminary prescription for change:

1. Stronger management and leadership systems: Surveys have shown that healthcare leaders recognize the need to overcome the issue of misaligned incentives and fill management gaps that have traditionally existed in healthcare. This would include adopting a more rigorous approach to succession planning; aligning performance management with strategic objectives; creating a consistent and structured operating calendar to support business planning, and utilizing methods that help to identify and develop potential leaders in the organization.

2. Use of Six Sigma: Results have been seen at a small but growing number of healthcare organizations through the use of Six Sigma methodology (primarily DMAIC) to reduce process variation and eliminate defects. The next phase will require building on that foundation, achieving “spread” through best-practice sharing, and applying both DMAIC and DFSS principles where appropriate – going beyond individual project successes to transform organizational culture.

3. Mistake proofing: Healthcare professionals must not only make it easier to do the right thing when it comes to patient care, in some cases it must be made impossible to do the wrong thing – applying poka yoke or mistake proofing to prevent errors such as wrong site surgery or leaving surgical instruments in patients. These are occurrences that the National Quality Forum and others have agreed should never happen.

4. Use of change management techniques: Studies show that more than 60 percent of major change initiatives are doomed to fail, often due to a singular focus on technical implementation while neglecting the human aspects involved. To avoid becoming one of the casualties, organizations should use proven techniques to build acceptance and accelerate the pace of change.

5. Application of Lean: There are numerous opportunities to apply the principles of Lean in healthcare, removing workflow redundancies and non-value added steps to facilitate a greater focus on the true priorities of patient care. Examples using Lean in the healthcare environment are beginning to accumulate illustrating improvements in areas such as admissions and discharge processes.

6. Access to high-quality continuing education: The need for training does not end with the acquisition of a medical or management degree. Especially given the rapid changes in healthcare, it is necessary to provide staff with an easily accessible system for upgrading skills and gaining valuable knowledge in both medicine and business management.

7. Optimizing technology and creating a unified IT infrastructure: The needs of each organization in this regard must be carefully analyzed based on a number of considerations including strategic goals, patient volume (current and projected) and input from referring physicians. For best results, technology changes should be well thought out and accompanied by educational and process changes.

8. Establishing cohesion: To reach HRO status and effectively move the organization to a higher level of excellence in providing patient care, all of the above elements must be sewn together as part of an overall strategy to create organizational transformation. Admittedly not an easy feat to achieve, it is clearly a goal worth pursuing and one that can be enabled through appropriate and early planning.

Summary: Momentum for Change Is Building

The financial, quality and leadership challenges confronting healthcare have been extensively chronicled in recent years. Unfortunately there is no quick fix or single solution to adequately address them all. The good news, however, is that momentum for change is building, and there is a growing awareness of the value in adopting and sharing a variety of best practices.

Creating a safe, high reliability and high performance environment in healthcare will require a unique combination of strategies, unremitting determination and the spreading of ideas from stakeholders on all sides.