Since his breakthrough 1994 article, “Error in Medicine,” Lucian L. Leape has been a progressive leader in efforts to change the culture of healthcare from a closed system that demands infallibility to an open system that embraces and learns from human error. The heroic and unprecedented change is already well underway and involves shifting long-standing and deeply held values that are not easily changed in any individual, much less across an entire industry like healthcare.
Physicians, nurses, and pharmacists are among the highest trained and careful professionals in our society, but the culture of medicine demands infallibility. The culture is introduced in medical school and residency when the learning process urges an error-free practice. The powerful emphasis on perfection is reinforced in hospital practice: mistakes are unacceptable. As a result, healthcare professionals naturally view errors as character flaws. This belief, combined with a physician’s feeling of ultimate responsibility to each patient, creates a no-win situation for everyone involved.
Several outcomes reveal the impact of this reinforced belief of infallibility. The culture reinforces it in a norm of covering up rather than revealing mistakes. “Physicians typically feel, not without reason, that admission of error will lead to censure or increased surveillance or, worst, that their colleagues will regard them as incompetent or careless. Far better to conceal a mistake or, if that is impossible, to try to shift the blame to another, even the patient.”1
The culture of hiding mistakes perpetuates the no-win situation where practitioners are blind-sided by professional and emotional fallout. “Physicians are emotionally devastated by serious mistakes that harm or kill patients. The emotional impact is often profound and typically a mixture of guilt, anger, embarrassment, and humiliation.” 2 They also have little recourse for alleviating the emotional impact, because many cultures do not welcome open discussion or offer support and emotional healing.
In a 2002 interview with Leape, he stated that there are two cornerstones to safety: 1) creating an environment where it’s safe for people to talk about their errors and, 2) leadership. He also points out the importance of shifting the way healthcare professionals are educated and trained. The traditional system focused on the physician as an individual with ultimate responsibility for patient outcomes. The complexity of technology and specialization surpassed that notion years ago, but the cultural norm is in many ways still prevalent.
“We need to change our training methods starting in medical school. Some people have proposed that it’s time to have medical students and nurses and pharmacists work as a team around some clinical problems in school so they get used to doing that. Clearly we have very different curriculum needs in terms of basic science and much of the specific training, but we should look for places where we can make common ground and give our young doctors experience working as part of a team.
We need to get beyond that and develop creative ways of involving patients and their caregivers much more in their care on a continuing, rather than episodic, basis. The second implication is that making available the full array of all that we can do for patients with chronic conditions involves tremendous complexity that requires a team effort. No individual doctor, nurse, technician, or therapist can meet all of a patient’s needs, and no one should try. We need to coordinate efforts and work together. It’s better for the patient and more satisfying to the workers.”3
Background
Everyone in the medical profession is well aware of the impact of 1999 report by the Institute of Medicine, “To Err is Human” The report presented astounding error rates of between 44,000 and 98,000 deaths each year in the United States as a consequence of human errors–more than from auto accidents (43,458), breast cancer (42,297), or AIDS (16,516)–and the IOM adds that a significant number of these deaths are preventable.
Those numbers are astounding and strike an emotional cord across the entire population because every person, at one time or another, needs medical care. The drama of the circumstances is heightened by the fundamental premise of the hippocratic oath: First, do no harm. Above all other professions, the sole purpose for practicing medicine is to relieve suffering, and for that healthcare professionals receive profound trust from their patients. The statistics represent a staggering disparity between intentions, delivery, and outcome. The result of the disparity is that health practitioners are just as devastated by the numbers as patients.
What gets missed when considering the statistics is that the overwhelming evidence proves that the mistakes reflect flaws in the medical systems, not the practitioners. “When individuals make mistakes, it’s because they’ve been set up to make mistakes. They’ve been put in situations where they’re more likely to make mistakes and they’re put in situations where it’s hard for them to recognize a mistake and head it off before it causes injury. That idea is a very powerful transforming concept in terms of the way we look at everything we do.”4
In recent decades that culture is changing. Atul Gawanda in his 2002 book, Complications: A Surgeon’s Notes on an Imperfect Science, states, “Everything we’ve learning in the past two decades–from cognitive psychology, from ‘human factors’ engineering, from studies of disasters like Three Mile Island and Bhopal–has yielded the same insights: not only do all human beings err, but they err frequently and in predictable, patterned ways. And systems that do not adjust for these realities can end up exacerbating rather than eliminating error.”5
There are profound examples of success from the aviation industry that stand as a model. The aviation industry changed its fundamental culture first by accepting that human errors are inevitable and designing systems that absorb those errors before they lead to catastrophe. They built in multiple buffers, automations, redundancy, and extensive ongoing feedback between the flight crew. Procedures are also standardized to the maximum extent possible. A study of transatlantic flights revealed that errors occur in the cockpit every four minutes but none of those errors lead to catastrophe because of the safety procedures implemented. Flight crews follow strict protocols for trip planning, operations, and maintenance. Pilots also undergo some of the most rigorous training, examination, and certification of any profession.
The final, and most powerful change that shifted the aviation culture was establishing a non-punitive system for error reporting. Pilots who report an incident within ten days have automatic immunity from punishment, and the reports go to a neutral, outside agency. The FAA recognized long ago that pilots seldom reported an error if it led to disciplinary action, so they established a confidential reporting system for safety infractions. This step opened up the opportunity for transparent and objective review of errors for fact-based learning. The results have been phenomenal: The risk of unintentional death in an airplane declined from one person in 2 million in the 1970’s to 1 in 8 million in during the 1990’s as a result of programs for setting and enforcing standards established by the Federal Aviation Administration.
There are also phenomenal results in the medical field of anesthesiology. “Whereas mortality from anesthesia was one in 10,000 to 20,000 just two decades ago, it is now estimated at less than one in 200,000. Anesthesiologists have led the medical profession in recognizing system factors as causes and designed fail-safe systems, and in training provide preventative systems.6 The new systems include features as common as building uniform and fail-safe machines that prevent harmful errors from occurring, and developing a state-of-the art anesthesia-simulation system known as Eagle Patient Simulator. 7
The Long and Winding Road to Change
The response to the IOM’s landmark findings have been dramatic. Both public and private organizations responded promptly with a flurry of activity and implementation of a variety of safety initiatives. The federal Quality Interagency Coordination Task Force (QUIC) supported the IOM recommendations and government health care systems began to implement the IOM proposals. As the result of Congress’s funding of $50 million for patient safety, the Agency for Health Research and Quality (AHRQ) in particular has moved aggressively to advance the cause of patient safety.
Progress in the private sector has also been impressive. Hospitals and health care organizations throughout America are implementing safety programs. Key professional organizations, such as the National Patient Safety Foundation, the American Hospital Association, the American Medical Association, the American College of Physicians, the American Nurses Association, the Association of Health Systems Pharmacists have expanded their focus on safety. Training, credentialing, and accrediting organizations, including the Accreditation Council for Graduate Medical Education and the Joint Commission on Accreditation of Healthcare Organizations have given patient safety new visibility by setting new standards and guidelines. Insurers and purchasing groups, such as the Leapfrog Group have made safety a priority in their contracting with providers. The patient safety movement is clearly launched. 8
Among the many challenging facing the healthcare industry in making this monumental shift, is to change the culture from a closed to open culture. In an address to the Senate Committee on Health, Education, Labor and Pensions in 2001, Leape stated,
“No voluntary reporting system will be successful, however, unless, like internal systems, reporting is safe. While some have suggested that physicians and hospitals should be required to publicly report all errors or accidents, such a proposal perpetuates the climate of blame and punishment that has been the major barrier to making progress in safety over the years. The evidence is clear that doctors and hospitals can readily avoid reporting incidents if it exposes them to risks of censure or litigation.
The potential for reporting of medical errors and incidents to contribute to patient safety is substantial. An oft-cited model is the “close-call” Aviation Safety Reporting System (ASRS) run by NASA, which has been successful because reporters are protected from disciplinary action and reporting leads to expert analysis and feedback of information to the FAA which makes procedural and other changes as needed. This voluntary system receives over 36,000 reports annually and has contributed significantly to aviation safety over the years. Properly managed, a medical incident reporting system could be even more successful.”9
The New Complexity of Care
Patient safety is only one example of the many dramatic changes facing the healthcare industry in the new millennium. Global healthcare is changing at a frenetic pace. In an effort to keep up with constant and exponentially changing technology and innovation, the two basic pillars of medicine (science and humanism) are changing, but in very different ways.
While the scientific pillar of medicine has grown in proactive and dramatic ways, the human pillar of medicine has evolved more slowly, and in a more reactive way rather than systematically driving change. The result has been a splintering of various trends in practicing medicine. One example is an overwhelming practice of defensive medicine, especially in the United States. This can be seen in the decline of autopsies as the primary tool for learning. Another example is that liability insurance in the U.S. costs more than $8 billion per year, putting the estimated costs of defensive medicine, by some estimates, at more than $20 billion.10
The U.S. healthcare system has also reinvented itself in the last two decades towards managed care where third party participants dictate who gets medical care, and how that care is delivered. The United states spends more per capita, and as a percentage of GDP, than any other developed nation in the world, yet the system excludes close to 20 percent of the population from insurance coverage, and the medical outcomes are not discernibly better than those achieved in other developed countries. 11
Another reactive change is a trend towards isolated and insular medical communities that don’t communicate and share information. One U.S. study, for example, revealed a stubborn, overwhelming, and embarrassing degree of inconsistency in the ways doctors deliver treatment. For example, the likelihood of a doctor sending a patient for a gallbladder-removal operation varies 270 percent depending on what city you live in; for a hip replacement, 450 percent, for care in an intensive care unit during the last six months of your life, 880 percent. A patient in Santa Barbara, Caifornia, is five times more likely to be recommended for back surgery for a back pain than one in the Bronx, New York. This is uncertainty at work, with the varying experience, habits, and intuitions of individual doctors leading into massively different care for people.” 12
The heroic change efforts underway to address medical errors demonstrate how quickly and effectively an entire community can join forces to promote positive change. Not all issues facing healthcare have such a universal personal stake, however, that helps drive that positive effort. For many issues, the causes are complex, the stakeholders vary, and the solutions are elusive.
Part of the problem is that, not so long ago, the human pillar of medicine was much simpler. Take the personal relationship of the doctor and patient. 20 years ago, no one invaded that face-to-face relationship. Today, however, just a few decades later, the transformation of healthcare has numerous participants who each have a stake in that face-to-face relationship. And each of them pull up a chair every time a healthcare professional and patient meet. They include a managed care, medicare or medicaide representative, insurance adjuster, hospital administrator, liability insurance agent, private or group medical practice managers, professional and paraprofessional staff, office managers, participating specialist physicians, and the list goes on.
In “Linking Assessment to Learning,” R.S. Handfield-Jones describes the nature of continuous learning for a doctor’s practice as a complicated environmental “swamp”:
“This journey (of continuing practice) includes many factors at increasing levels of organizational complexity: autonomous patients with their individual needs; families, practice contexts and settings; other health care workers; medical and regulatory organizations; and broader social and community issues.”13
Add to this the new well-informed, internet-influenced patient. Many healthcare professionals refer to “old” and “new” patients, but not meaning their age. “New” patients arrive with more current information about diagnosis or treatment, sometimes more than the provider. This is another challenge to the old paradigm of healthcare delivery that practitioners contend with on a daily basis. They also have to deal with legal issues, informed consent, and treating patients more as partners than subordinates who blindly follow recommendations.
Recovering the Human Pillar of Medicine
In 2002 the Institute of Medicine (IOM) issued another report titled, “Crossing the Quality Chasm: A New Health System for the twenty-first century.” It defines six specific areas in which significant improvements need to be made:
Care should be:
- safe
- effective
- patient-centered
- timely
- efficient; and
- equitable
The IOM report also includes 10 rules to guide patient-clinician relationships in an improved health system:
- Care should be based on continuous healing relationships
- Care should be customized based on patient needs and values
- Care should be decision-making control should reside with the patient
- Knowledge and information should be shared with the patient
- Clinical decisions should be evidence-based
- Care systems should be safe
- The health systems should be more transparent, allowing patients and families to make informed decisions
- The health system should anticipate needs rather than simply reacting to events
- The health system should not waste resources or patient time; and
- There should be more cooperation among clinicians to ensure an appropriate exchange of information and coordination of care.
This kind of change cannot occur without stakeholders mobilizing efforts to collaborate and share information with continuous flexibility and objectivity. Dramatic culture change of any magnitude cannot take place without a shared commitment among all of the key players, from the top executives down to the hourly wage earner. To meet these new standards of excellence, the healthcare industry needs to continue expanding the culture of openness. These changes demand unprecedented teamwork that capitalize on human resources in creative and innovating ways. The changes need to transcend technology and innovation to integrate relationships at every level based on mutual, trust, respect and candor. Everyone in the healthcare industry has a stake in, and stands to benefit from, building a sound foundation of relationships throughout the profession.
How do you shift the values and beliefs in healthcare professionals so that people openly and willingly share information, including information about errors? How do you shift the learning models used since medical school and early education to open, team-based approaches to learning? How to you establish sound critique practices so that people maximize the resources that each person brings to a healthcare team with a “what’s best” not “who’s best” approach?
As Leape points out, the shift away from an individual, isolated approach and towards a team approach is critical. No one person can hold all the information needed to deliver the best quality care. “Current approaches rely on strategies directed at individuals only, but in real life, doctors’ work is characterized by multiple complex professional interactions. These interactions involve different kinds of teams and are embedded within the overall context and systems of care. In addition to individual factors, therefore…the performance of doctors in health care teams and systems will also impact on the overall quality of patient care.” 14
And this change should start in medical schools so healthcare professionals learns the benefits of teamwork synergy from the outset of their training. But early training is not enough. In reality, teamwork is no longer a choice and defines a core element of continuous learning throughout healthcare. People must be able to work in teams in order to carry out the most basic care. “Focusing on the individual does not take into account broader parameters that are potentially more influential in improving quality of care. These parameters include the performance of doctors within the teams and systems in which they work…Moreover, the ability to work in teams has now been incorporated into new operational definitions of competence, particularly where models of health care delivery are changing.” 15
Two primary features are fundamental for effective culture change:
- To develop a clear model, a shared understanding of the soundest practices for a healthy culture, and then compare that understanding with the actual culture in place. This model includes specific features that define what conditions and behaviors people value as sound and guide each person in their daily activities. The comparison of the ideal and actual culture reveals gaps between where people want to be and where they actually are now. The gap provides the map.
- Learning and practice teamwork skills (like critique, conflict resolution, and decision making) provide the compass and roadmap for getting from sound to actual. Sound relationship skills constantly reinforce the healthy relationships and healthy culture through continuous improvement.
In 2002, the National Academies Institute of Medicine published a book entitled, Speaking of Health, in which they recommend using theory-based change strategies.
“Communication and behavior change theories provide a powerful tool for organizing our thoughts, the existing evidence, and cultural realities so that health communication interventions can be more comprehensive, more sophisticated, and more likely to have the desired effects on health behavior change.” 16
The Healthcare Grid Theory articulates an empirically proven theory of human behavior that has been phenomenally effective in leading change across many industries around the world over for the past 40 years. The theory and methods were also instrumental in driving error-related culture change in the aviation industry.17 In addition to providing a model of what’s possible, a pathway to get there is also included in the form of a proven methodology for turning concepts, ideas, and values into operational realities.
Just as healthcare delivery ultimately happens one patient at a time, change happens one person, and one relationship at a time. Change begins at the individual level by addressing how people’s behaviors impact others. With that awareness, individuals then explore their relationships in teams, and work to build mutual trust and respect around new values and attitudes. Change then spreads across an entire organization and, ultimately, across an entire industry.
To be effective, change must be self-convincing. Grid theory and methodology delivers the kind of change that Leape recommends by making the team the primary unit of learning. Team-based learning designs promote collaboration and trust rather than the traditional top-down approach to learning.
References
- Leape, L.L “Error in Medicine”; JAMA, December 21, 1994–vol. 272, no. 23, p. 1852.
- Leape, L.L “Error in Medicine”; JAMA, December 21, 1994–vol. 272, no. 23, p. 1852.
- MANAGED CARE July 2001. ©MediMedia USA, A Conversation with Lucian Leape, M.D., Moving Beyond A Punitive Mind-Set
- MANAGED CARE July 2001. ©MediMedia USA, A Conversation with Lucian Leape, M.D., Moving Beyond A Punitive Mind-Set
- Gawande, Atul: Complications: A Surgeon’s Notes on an Imperfect Science; 2002: New York: Picador: Henry Holt and Company; page 62-63.
- Leape, L.L “Error in Medicine”; JAMA, December 21, 1994–vol. 272, no. 23, p. 1856.
- Gawande, Atul: Complications: A Surgeon’s Notes on an Imperfect Science; 2002: New York: Picador: Henry Holt and Company; page 68.
- Prepared Statement of Lucian L. Leape, M.D. Harvard School of Public Health Subject-Reporting and Prevention of Medical Errors-Before the Senate Committee on Health, Education, Labor and Pensions
- Prepared Statement of Lucian L. Leape, M.D. Harvard School of Public Health Subject-Reporting and Prevention of Medical Errors-Before the Senate Committee on Health, Education, Labor and Pensions
- Lundberg, George D. Severed Trust: Why American Medicine Hasn’t Been Fixed; 2002/2000: Basic Books, p. 37.
- Lundberg, George D. Severed Trust: Why American Medicine Hasn’t Been Fixed; 2002/2000: Basic Books, p. 5.
- Gawande, Atul: Complications: A Surgeon’s Notes on an Imperfect Science; 2002: New York: Picador: Henry Holt and Company; page 248-249.
- R.S. Handfield-Jones: “Linking Assessment to Learning,” Blackwell Science Ltd Medical education 2002; 36:949-958”
- Farmer, Elizabeth A, Beard, Jonathan B., Dauphinee, Dale W., LaDuca, Tony, Mann, Karen: Assessing the Performance of Doctors in Teams and Systems; 2002: Papers from the 10th Cambridge Conference: Medical Education 2002; 36: 942-948.
- Farmer, Elizabeth A, Beard, Jonathan B., Dauphinee, Dale W., LaDuca, Tony, Mann, Karen: Assessing the Performance of Doctors in Teams and Systems; 2002: Papers from the 10th Cambridge Conference: Medical Education 2002; 36: 942-948.
- Speaking of Health: Assessing Health Communication Strategies for Diverse Populations; Institute of Medicine of the National Academies; Washington D.C.: 2002: The National Academies Press, p.69.
- “Optimum Culture in the Cockpit”: 1990 Hisaaki Yamamori/Japan Airlines and Cockpit Resource Management.