In 1999, the Institute of Medicine (IOM) reported that 44,000 to 98,000 Americans die each year as a consequence of medical error. These alarming figures published in the IOM article, To Err Is Human: Building a Safer Health System (Kohn, Corrigan, and Donaldson, 1999) caught the attention of health care professionals worldwide and radically transformed the patient safety perspective. In 2001, the IOM published a second report, Crossing the Quality Chasm: A New Health System for the 21st Century which criticized the U.S. health care system’s failure to provide consistent high-quality medical care. The report also emphasized the need for health care’s administrative and clinical leaders to create a culture of safety, one that can protect patients from injury. However, a culture of safety doesn’t just materialize – it calls for motivated leadership and a strategic plan to direct the organization towards the goal of a safety culture. Nowadays, patients are becoming more aware when it comes to quality health care, and they want to be certain that they are getting medical treatment that is safe, timely, effective, efficient, equitable and patient-centered. In this paper, we will examine the fundamental principles of safety and reliability, study the unique role of leadership in making and keeping an environment devoted to harm-free care, and look at ways to bring about a patient safety-oriented culture.
Error and Harm in Health Care
Health care is a complex industry. Things will always go wrong as errors ubiquitously exist. According to Leonard, Frankel, Simmonds, and Vega (2004), “An ever increasing body of evidence indicates that at least 80 percent of medical error is system derived – meaning that system flaws set good people up to fail” (p.5), and that “…only about 5 percent of medical harm is caused by incompetent or poorly intended care” (p.7). Thus, no matter how cautious and vigilant one person is, there are flaws in the system that no single individual can triumph over.
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About twenty years ago, the epidemiology of medical error was simple: “Error is due to carelessness. Blame and punishment is the response” (Leape, 2001). In essence, the focus of error was the action (or inaction) of individuals. Unfortunately, reprimanding people and telling them to be more careful did not create a safer care delivery system. For quality health care to occur, medical errors must be viewed as a testament of a bigger problem, and as a data resource to prevent injury. The spotlight should be on the system and on apprehending specific processes and technical activities, not on blaming and punishing people. An organization that believes that people are the problem will in no way be able to engender a culture of safety. The leader’s job, in this case is to build systems that prevent harm and to implement solutions that deal with specific problems within the system. Leaders do well to heed to Battista’s words: “An error doesn’t become a mistake until you refuse to correct it”. Reason (2001) also points out that it is how we understand and respond to error that decides whether harm or injury can later result. The journey to a safety culture must therefore begin by changing responses to medical errors and inadvertent incidents. Leaders have to alter their retorts to mistakes and failures by primarily asking ‘what happened’ instead of ‘who made the error’. In other words, leaders must embrace error to eliminate harm.
Fundamental Patient Safety Theories
A culture of safety must be built on the knowledge of safety principles and safety concepts. Basic safety principles include: “Risk of failure is inherent in complex systems, risk is always emerging, not all risk is foreseeable, people and systems are fallible, and clinicians can create safety every day by recognizing and compensating for risks in the work place” (Morath and Turnbull, 2005). In addition, dispelling health care myths is just as important as knowing the principles of safety. These myths as stated by Morath and Turnbull are: “clinicians are supposed to be infallible, bad things happen only when people make mistakes, people who fail are bad, and blame and punishment sufficiently motivate people to be more careful thereby avoiding future mistakes”. To create a culture of patient safety, leaders must rethink their beliefs and realize that risk is always present and constantly emerging. Rijpma (1997) notes that the following safety paradigms: Normal Accident theory and High Reliability Organization theory can provide valuable insights in understanding the nature of error causation and prevention.
Charles Perrow, the author of Normal Accident Theory, explains that accidents are inevitable because of system complexity. According to the theory, systems with ‘interactive complexity’ and ‘tight coupling’ will experience accidents that are inevitable and therefore in a sense ‘normal’. Marais, Dulac, and Leveson (2004) refers to Interactive complexity as the presence of unfamiliar or unplanned and unexpected sequences of events in a system that are either not visible or not immediately understandable; and a tightly coupled system is one that is highly interdependent. Each part of the system is closely linked to many other parts and therefore a change in one part can quickly affect the status of other parts. Basically, the more tightly coupled the work processes, the greater the possibility of an accident (Perrow, 1999).
Safety is one of various organizational goals that can be practiced with high reliability. The high-reliability organization theory was developed by a group of scientists at the University of California at Berkeley based on their field studies of high-reliability organizations (HRO) that achieved incredibly low accident and error rates. In order to improve patient safety, healthcare organizations must strive to emulate HRO industries such as aviation, nuclear power, hazardous chemicals, and military operations. Roberts (2001) explained that these industries were able to achieve high reliability because ‘they actively seek to know what they don’t know, design systems to make available important knowledge that relates to a problem to everyone in the organization, learn in a quick and efficient manner, aggressively avoid organizational arrogance or the belief “errors cannot happen here,” train organization staff to recognize and respond to system abnormalities, empower staff to act, and design redundant systems to catch problems early’. Thus, for health care leaders to attain HRO status, they must incessantly prepare for unanticipated failures while averting known causes of failure.
According to Leape (1997), countless errors develop from system failures. James Reason’s ‘Swiss Cheese Model’ of system failure rationalized that a combination of multiple small failures, each individually insufficient to cause an accident, usually come together to create failure in a complex system (Reason, 1990). In essence, the system is comparable to a pack of slices of Swiss cheese. Each slice acts as a “defensive layer” in the process and the holes are viewed as opportunities for a process to go wrong. For a medical error to occur, the holes need to align for each step in the process. Thus, each slice of cheese is seen as an opportunity to stop an error. Fewer holes in the system can also inhibit errors from taking place.
Designing reliable processes includes judicious assessment of existing processes, sensible planning, and the use of the science of reliability. Leaders must know and continually use that science in the organization as it is vital to their role. Berwick and Nolan (2003) defined reliability as “the capability of a process, procedure or health service to perform its intended function in the required time under commonly existing conditions”. Approximately 72 percent of medical accidents are recurrent (Leape, 1991). On the other hand, if medical accidents are recurrent, then they are foreseeable and therefore avoidable. The function of safety is to redesign and implement enhanced processes and systems to prevent medical accidents from recurring.
The Systems Thinking Approach
A systems thinking approach to creating and maintaining reliable processes is needed for patient safety. Systems thinking makes the primary assumption that medical accidents are indications of a faulty system. It also identifies individual human performance or nonperformance but puts more weight on system weaknesses. At heart, systems thinking is the practice of studying systems from a holistic point of view that entails comprehending interdependent structures, sequences, and patterns in systems, instead of analyzing only certain events in the system. The IOM publication, To Err is Human has endorsed specific concepts to improve health care. These concepts are: “medical accidents happen as a result of system defects and not because of individual performance, patient injury will lessen if safer systems of care are designed, and the culture of health care must change for safer systems of care to work”. Overall, efforts to lessen harm and reduce error should be aimed at the work processes in the system of care delivery. Leaders must also believe that harm free-care is feasible. If leaders do not believe that harm-free care is attainable, they will never be able to achieve a culture of safety for patients and staff.
Developing Effective Safety Leadership
Leadership is key to creating a patient safety culture, and effective leadership is an indispensable prerequisite to sustaining it. Leaders, through their language and action can change and transform culture by influencing the way others see reality (Carillo, 2010). Without the commitment of leadership – board of directors, senior leaders, physician and nursing leadership – and the “restlessness about the status quo” (a concept introduced by Schein, 1992), performance improvement and enhanced safety within the organization cannot be maintained. In short, an enduring safety culture is highly unlikely. Ginsburg, Chuang, Berta and others (2010) highlighted that both formal and informal leadership is considered necessary to forming and sustaining an organizational safety culture. All the same, leadership is critical when it comes to organizational improvement and not just safety aspects. Rupp, Bonacum, Frush and others noted seven leadership steps that have to be performed to attain patient safety (The Essential Guide for Patient Safety Officers, 2009):
Step One: Assess the culture for safety and act to close the gaps.
Step Two: Understand the science of improvement and reliability. Strive to be a high reliability organization.
Step Three: Foster transparency.
Step Four: Create a leadership promise.
Step Five: Engage physicians and nurses, especially those in executive and formal leadership roles.
Step Six: Hire for what you aspire to become.
Step Seven: Involve board members in the safety journey.
Furthermore, the role of leadership in relation to creating and maintaining a patient safety culture is to set up the value system in the organization; establish strategic objectives for specific activities to be carried out; line up efforts in the organization to accomplish those objectives; provide resources for the design, expansion, and sustainability of efficient systems; eliminate barriers to improvements for health care staff; and insist on compliance to well-known practices that will support patient safety.
Building a Culture of Safety
Changing the culture of an organization is fundamental to creating and sustaining patient safety. Culture consists of an organization’s shared values, beliefs, and behaviors. It influences the way members think, act, and approach their work. What’s more, culture strengthens commitment to organizational goals and provides direction by reinforcing standards of conduct. On the whole, culture signifies the organization’s unique way of doing things.
Carillo (2010) points out that there are visible and invisible elements of an organization’s culture. The visible elements consist of organizational policies, procedures, language, stories and symbols, and the invisible aspects comprise the beliefs and assumptions that affect how people think and act. In order to instill a culture of safety, an organization’s beliefs and assumptions must be amended. Kotier (1990) conveys six key tasks that have to be performed to facilitate organizational change: “establishing direction, aligning people, motivating and inspiring people, planning and budgeting, organizing and staffing, and controlling and problem solving”. However, organizational change is not an instant process. Changing behaviors into a desired form takes time, devotion and persistence. It also takes patience, as people do not simply or readily change.
Morath and Turnbull (2005) state that four subcultures must be established to create a patient safety culture: an accountable culture, a just culture, a learning culture, and a culture of partnership. An accountable structure is a culture in which leaders acknowledge full responsibility for patient safety. There is no room for blame and shifting the responsibility. in fact, being accountable means telling the truth even when the truth is complicated and painful. Moreover, an accountable structure should exhibit the traits of a high reliability organization during its performance (Morath and Turnbull, 2005). A just culture is a culture of trust in which people are encouraged to provide essential safety-related information, but in which they are also clear about where the line has to be drawn between acceptable and unacceptable behavior (Reason, 1997). A just culture is characterized by systems thinking, organizational learning, well-developed decision-making mechanisms, and clear organizational structures (Connor, 2007). A learning culture has deep admiration and an unappeasable pursuit for understanding how the system works and why events arise. It is characterized by “the willingness and the competence to draw the right conclusions from its safely information system and the will to implement major reforms when their need is indicated”. Finally, a culture of partnership is a culture based on effective teamwork, communication and the interactions of people within the system. This part of the organizational culture also includes the patient and the patient’s family as team members.
The Institute for Healthcare Improvement (IHI), following several years of leading organizations in patient safety, recommends eight steps to achieving a culture of safety in health care organizations (IHI Innovation Series: Leadership Guide to Patient Safety, 2006):
Step One: Address Strategic Priorities, Culture, and Infrastructure
A. Establish Patient Safety as a Strategic Priority
B. Assess Organization Culture
C. Establish a Culture That Supports Patient Safety
D. Address Organization Infrastructure
E. Learn About Patient Safety and Methods for Improvement
Step Two: Engage Key Stakeholders
A. Engage the Board of Trustees
B. Engage Physicians
C. Engage Staff
D. Engage Patients and Families
Step Three: Communicate and Build Awareness
A. Begin Patient Safety Leadership WalkRounds
B. Implement Safety Briefings
C. Improve Communication Using SBAR (Situation-Background-Assessment-Recommendation) Technique
D. Implement Crew Resource Management Strategies
Step Four: Establish, Oversee, and Communicate System-Level Aims
A. Establish Aims Beyond Benchmarks
B. Oversee and Communicate System-Level Aims
Step Five: Track/Measure Performance Over Time, Strengthen Analysis
A. Measure Harm Over Time as a System-Level Measure
B. Improve Analysis of Adverse Events
C. Strengthen Incident Reporting Mechanisms
Step Six: Support Staff and Patients/Families Impacted by Medical Errors
A. Provide Support to Staff and Patients or Families Impacted by Medical Errors and Harm
B. Ensure the Safety of Staff
Step Seven: Align System-Wide Activities and Incentives
A. Align System Measures, Strategy, and Projects
B. Align Incentives
Step Eight: Redesign Systems and Improve Reliability
A. Redesign Care Processes to Increase Reliability
B. Implement Rapid Response Teams
C. Introduce Simulation
D. Implement a Computerized Physician Order Entry System
Conclusion
Patient safety is a prime issue being confronted by health care organizations today. In this paper, we highlighted important safety paradigms, discussed the essentials of a safety culture and noted the importance of capable and engaged leadership. In summary, it is the leader’s job to create a culture of safety; amending an organizational culture is needed to instill a culture of safety; lastly, both leadership commitment and an organization’s culture of safety are necessary for patient safety.
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