Learn why changing institutional culture is essential for the well-being of patients, practitioners and administrators alike.
Nothing demands more focus and energy from a physician leader than creating a safe environment for patients, patients’ families and the workforce. Since the publication of To Err is Human in 2000, the public has become more aware of the unsafe environment in health care.1
It has been estimated that between 44,000 and 98,000 patients die each year in the United States because of medical error. In 2004, that figure was estimated at more than 195,000.2 A 2013 estimate placed it at between 210,000 and 440,000 deaths.3 And a 2014 study showed more than 12 million missed diagnoses in the United States every year4 — an estimate that compounds the problem of medical error.
Physician leaders, as well as the entire health care system, must be focused on the issue of patient safety as the core of quality health care. Patient safety is best defined as the “freedom from accidental injury.”1 Most errors originate either from a planning failure or an execution failure.5 A planning error is when the wrong care plan was selected, but was carried out appropriately, while an execution error occurs when the right care plan was selected, but not carried out correctly.
Patient safety is a strategic imperative that must be initiated, led and managed by an organization’s senior leaders, including its board of directors. Senior leaders cannot delegate this process to a lower team.6 Imbedding patient safety procedures into an overall organizational strategy sets in place a powerful aim and direction of senior leaders.
Physician leaders must create a culture of patient safety in their organizations. A starting place is to insert the framework of a “just culture” into the workforce.7
In a just culture, individuals shouldn’t be held responsible for errors that occur because of system issues over which the individual has no control. On the other hand, individuals should be held accountable for those actions under their control. A just culture provides a framework to follow in order to achieve an environment of patient safety by allowing individuals to report errors without fear of retribution, with a focus on four areas:
- Creating a learning culture in which an organization constantly applies new ways to establish safe patient-care practices.
- Creating an open and fair culture in which the workforce is not afraid to report errors.
- Designing safe systems that require the organization, led by senior leaders, to have continuous improvement processes in
- Training the workforce in how to manage their individual behavioral choices for the betterment of patients.
Balancing “no blame of the workforce” with “accountability of the workforce” can be a difficult task for health care organization’s leaders — particularly when it comes to physicians.8 Traditionally, physicians have been independent of oversight and therefore not fully accountable to the organization, except via the rules and regulations of an organized medical staff that typically has weak enforcement capability.
Physician leaders should have an open—and ongoing—discussion with their medical staff about the principles and practices of patient safety. In order to have this ongoing discussion, physician leaders need to continually educate themselves in the science and practice of patient safety.
Changing the Culture
In complex health care organizations, a hierarchy of factors contribute to the lack of safety.9 These factors include the institutional culture, management and leadership issues, the work environment, the care team and tasks at hand, communication and patient handoffs, among others.
Care teams, individual providers and patients have been referred to as the sharp end of the health care system.10 However, the causes of error do not always begin and end there. Rather, in many cases, safety issues begin at the blunt end — which can include administrative decisions, environmental design and the existing institutional culture.
A primary imperative in achieving a high level of patient safety is the need to transform the culture.
Foremost, a new physician leader must evaluate his or her institutional culture and assess the willingness of other senior leaders to create a safe environment for patients and staff. This can be done by using cultural survey tools. Most cultural surveys have intrinsic limitations, but they generally serve as guides to help senior leaders make necessary changes within their organization so that a patient safety-oriented culture can be established.11 Survey results can help senior leaders by providing insight into the organization’s patient safety issues.
Physician leaders also must recognize that there are important tactics available to help reduce errors and promote safe environments.12 These tactics fall into five general categories:
- Reducing complexity of the care processes.
- Optimizing information processing.
- Automating wisely.
- Using constraints so that human error can be blunted.
- Mitigating the unwanted side effects of change.
Reducing complexity of any process or technology makes perfect sense. Anytime a process or technology becomes too complex, humans have difficulty in sequentially managing them.12 Complexity can be reduced by decreasing the number of steps in the process or reducing the number of choices that an employee is able to make. Other ways include decreasing task or process execution time, making information required for a task easier to understand and assimilate, and reducing any distractions that may interfere with the task or process.
Optimizing information processing is a safety technique used to increase an individual’s understanding and reduce his or her reliance on memory.12 Optimization of information processing can be accomplished by using checklists, protocols and reminders that can be as simple as handwritten notes about how to use certain computer-based clinical decision tools. An important consideration about technology is to ensure that it supports, rather than supplants, an individual’s decisions.
Automation is rapidly increasing as organizations in every industry seek to improve productivity and reduce costs. In health care, automation sometimes increases complexity and therefore might make a given situation more unsafe. With automation, it’s important to make sure technology blends seamlessly into the work processes without creating its own safety problems.12
Using constraints, which restrict the actions of an individual or system, is an evolving and important safety tool.12 Constraints can be categorized into three general types: physical, procedural and cultural. A physical constraint is something that restricts the interchange of physical items — such as an oxygen hose that’s designed to fit only the oxygen tank and not the nitrogen gas cylinder. Procedural constraints restrict certain tasks from being carried out — such as stop orders, warnings or limitations on what an individual can do. Cultural constraints help set acceptable behavioral standards that provide a framework for both an individual and an organization to follow in order to function effectively.12
Managing the Change
When introducing new technology or processes, senior leaders must be aware of the potential for unwanted effects to occur. Failure modes and effects analysis is one important tool they can use. Originally developed by reliability engineers, FMEA helps predict adverse issues that might occur with a new technology. This is done by evaluating complex processes, identifying elements that have a risk of causing harm, and selecting remedies.13,14
FMEA has been used to examine new process changes in the delivery of intravenous drug infusions, for example.13 By testing or piloting a new technology or process before full implementation, errors might be reduced because they were already evaluated and corrected.12 That also might include reduction of the nonlethal costs that can occur in unsafe environments — for example, the financial impact of postoperative complications.15
A physician leader might also consider implementing human factors engineering in patient safety.16 HFE deals with the design of equipment, machines, environment and systems that includes the consideration of human capabilities and limitations. HFE includes many biomedical disciplines such as ergonomics, anthropometrics, biomechanics, sensation and perception, anatomy and physiology, and cognitive physiology.
Finally, a major key toward developing and sustaining a patient safety program is the creation of an environment of teamwork. It is now recognized that team performance in health care is crucial to providing a safe patient environment.1 A lack of teamwork is seen as an important contributing factor to adverse events rather than the lack of clinical skills.17
Patient safety is an all-encompassing construct that represents a difficult problem for any physician leader to manage in an efficient and workable manner. The Institute for Healthcare Improvement has outlined steps for patient safety and high reliability that physician leaders should consider.6 They are:
- Addressing the strategic priorities of their organization.
- Addressing the culture of the workforce — which begins with the leadership team and board of directors, because these two groups will lead the cultural transformation that elevates patient safety to the highest priority.
- Addressing organizational infrastructure, including assessment of the necessary software requirements and patient-safety trained personnel needed to manage a comprehensive patient safety program.
Key stakeholders can make or break any initiative. Physician leaders should analyze the organization’s key stakeholders to recognize those that might be early adopters of a patient safety program as well as those that might be roadblocks.
A defined and well-managed communication plan or process can help build awareness and keep the workforce informed. Physician leaders should oversee senior-level efforts to establish and communicate the system-level patient safety aims. These aims should be incorporated into the organizational strategic plans, linked to key performance measures and have assigned leadership tasks, with results reported to senior leaders and directors.
Physician leaders should develop organizational plans and processes that directly support the patients, families and staff members affected by medical error. Likewise, special effort should be directed at creating an organizational process that helps providers through the emotional stresses that often follow a medical error.
Finally, physician leaders should be on the forefront of the activities that redesign processes and create high reliability for the organization.
Eugene Fibuch (1945-2017) was professor emeritus at the School of Medicine and co-director of the physician leadership program in the Henry W. Bloch School of Management at the University of Missouri in Kansas City. This article is part of an ongoing series he submitted in 2016.
Jennifer J. Robertson, MD, MSEd, FAAEM, is an assistant professor in the emergency medicine department at Emory University in Atlanta, Georgia.
- Kohn LT, Corrigan JM, Donaldson MS (eds). Committee on Quality of Health Care in America, Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
- In-hospital deaths from medical errors. 2004; Aug. 9, Medical News Today.
- Lieber JB, How to make hospitals less deadly. Wall Street Journal, May 18, 2016.
- Singh H. The battle against misdiagnosis. Wall Street Journal. Aug. 8, 2014
- Reason J. 1990. Human Error.Cambridge University Press. New York.
- Botwinick L, Bisognano M, Haraden C. Leadership Guide to Patient Safety.IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2006. (Available on IHI.org).
- Wachter RM, Pronovost MD. Balancing “No blame” with accountability in patient safety. 2009. NEJM. Vol. 361 (14); pp. 1401-1406.
- Vincent C, Taylor-Adams S, Stanhope N. Framework for analyzing risk and safety in clinical medicine. BMJ. Vol. 316; pp. 1154-1157.
- Cook RI, Woods DD. Operating at the sharp end: the complexity of human error. In: Bogner MS, editor. Human error in medicine. Hillsdale, NJ. Erlbaum, 1994; pp 255-310.
- Singla AK, Kitch BT, Weissman JS, Campbell EG. Assessing patient safety culture: A review and synthesis of the measurement tools. 2006. J Patient Saf. Vol. 2 (3); pp 105-115.
- Nolan T. System changes to improve patient safety. 2000. BMJ, Vol. 320 (7237), pp771-773.
- Apkon M, Leanoard J, Probst, et al. Design of a safer approach to intravenous drug infusions: failure mode effects analysis. 2004. Qual Saf Health Care Vol 13 (2): (2004) pp. 265-271.
- Grissinger M, Rich D. JCAHO: meeting the standards for patient safety. Joint Commission on Accreditation of Healthcare Organizations. 2002. J Am Pharm Assoc (Wash). Vol 42 (5 Suppl 1): pp S54-5.
- Bratzler DW, Hunt DR. The surgical infection prevention and surgical care improvement project: National initiative to improve outcomes for patients having surgery. 2006. Clin Infect Dis. Vol. 43 (3), pp. 322-330.
- Gosbee J. Human factors engineering and patient safety. 2002. Qual Saf Health Care. Vol. 11, pp. 352-354.
- Manser T. Teamwork and patient safety in dynamic domains of healthcare: a review of the literature. 2009. Acta Anesthesiol Scand. Vol. 53; pp.143-151.