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Abstract

The debate in bioethics around patient safety deals with the pervasive problem of medical error. A traditional reaction to medical error in the past focused on blaming individual professionals. This punitive method was called the professional sanctions model. However, it was unsuccessful insofar as medical errors continued extensively. An alternative is called the patient safety model. This new approach focuses on the organizational systems and processes underlying medical error. The goal is to shift from being reactive and punitive to being proactive and positive in the sense of preventing error and enhancing safety. At the core of this new method is the root cause analysis of errors to identify the underlying systems and processes that create an environment in which mistakes occur. This results in fostering a safety culture that encourages organizations to identify mistakes, to prevent sentinel events, and to support patients and families who have been hurt. As a result, this approach calls for better national reporting mechanisms of medical error to enhance patient safety in healthcare across the world.

Introduction

The debate in bioethics around patient safety deals with the pervasive problem of medical error in healthcare. This is a global problem insofar as the extent of avoidable medical error is enormous, causing very large numbers of deaths and even higher numbers of serious injuries. For example, in the USA, a famous report was published by the Institute of Medicine in 2000 called To Err is Human: Building a Safer Health System (IOM 2000) – this will be referred to as the IOM Report. The report calculated that up to nearly 100,000 deaths were occurring as a result of medical error each year in the nation. These numbers were calculated based on previously published data – though subsequent research has suggested that the number could be much higher. The puzzling issue is why the general public has not become upset about the extent of the problem. The explanation is that medical errors and deaths occur to one patient and in one hospital at a time. The lack of a central reporting mechanism to track the problem has made it very difﬁcult for the public to understand what is going on. If the public became aware of the extent of the problem, public debate and widespread advocacy would likely result. Following this IOM Report, many organizational systems were implemented in healthcare to ameliorate the problem. A similar approach has occurred worldwide insofar as healthcare is now more attentive to designing and implementing organizational systems to prevent medical errors and to promote patient safety. This analysis discusses this focus on patient safety in healthcare as a function of organizational ethics.

Background

Until the turn of the millennium, the general approach to medical error across the world was to blame the clinician for negligence or malpractice. Typically, hefty penalties accrued not only as a punishment to the individual concerned but also as a warning to other clinicians to avoid similar conduct. In one sense this accusatory and reactive approach made sense insofar as a patient either died because of a medical error or suffered signiﬁcantly – redress was sought through punishment to prevent recurrence. However, this seemingly plausible reaction had very little impact on reducing the extent of medical error in healthcare. Hence, another approach emerged that initially seemed odd insofar as it shifted the blame from the individuals causing the medical error. The blame shifted to organizational systems in healthcare that were construed as being faulty or inadequate, creating an environment that made medical error possible. The basic idea was to ﬁx the systems underlying medical error rather than to ﬁx blame on good clinicians who were caught up in problematic structures. Of course, this new approach does not ignore the continuing need for investigations into intentional or reckless behavior around which malpractice legitimately revolves.

This shift from ﬁxing blaming on individuals to ﬁxing underlying systems has occurred in healthcare across the world in an effort to protect patients from medical error. As a result, the focus on organizational systems that cause medical error has generated a new emphasis in organizational ethics upon patient safety in healthcare. To discuss this dramatic shift in healthcare globally, the analysis considers the varying types of medical error and the contrasting models to deal with the problem (Magill 2013, 2006; some of the concepts from these publications have been incorporated and developed for this contribution). The goal is to move away from a paradigm of heat and blame to a paradigm of light and remedy. This means avoiding a focus on blame where individual clinicians are accused of causing medical errors. The alternative is to shed light on the controversy by examining the root causes of medical error to implement organizational remedies that support patient safety.

Medical Error And The Safety Paradigm

It can be helpful to note that discussions about patient safety can transfer to safety of human subjects in medical research. There are well-known examples of patients dying in research protocols, such as Jesse Gelsinger who was the ﬁrst patient to die in a research protocol on gene therapy. However, the purpose of this analysis is patient safety – considering the safety of patients, not research subjects or scientiﬁc misconduct. The ethical implications of medical error negatively impact not only patients by compromising their safety but also healthcare professionals and organizations by placing them in untenable situations. Medical error constitutes a foundational compromise of the basic tenets of professional standards of practice and of an organization’s integrity insofar as patients are killed or injured. The problem for professionals and organizations is compounded when they try to cover up the medical error or explain it away to patients who may not be able to understand medical causality. As a result, the ethical debate around patient safety is not just about the quality of care but also about professional standards of practice and organizational integrity (Panesar et al. 2014). To engage the ethical debate around patient safety, it is necessary to have a sense of the extent of medical errors in healthcare.

Medical errors can occur in any stage of care from diagnosis to treatment, including preventive care. There are different types of errors, often clustered into medication errors, surgical errors, and diagnostic errors (Wachter 2012). There are many ways in which diagnostic errors occur: for example, there can be a mistake or delay in clinical diagnosis; there can be a failure to provide relevant or indicated tests; and there can be a failure to act on the results of tests or when using tests that are outmoded. Furthermore, there are many ways in which treatment errors occur: for example, during surgery; in avoidable delay in treatment; when there is inappropriate care; and when prescribing, dispensing, administering, and monitoring medications. Also, many other forms of medical error occur: for example, when there is communication failure or equipment malfunction, when there is fatigue among clinicians, when there is poor infection control, etc. The list of errors and their varying types goes on expansively.

This variety of medical error generates a broad deﬁnition of patient safety as freedom from accidental injury. In general, the approach to medical error that is adopted here reﬂects the philosophy of error in the work of James Reason (1990, 1997). In this broad context medical error can be deﬁned as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Even though not every medical error actually harms a patient, a category of errors can be speciﬁcally designated to identify those that cause harm to patients. These are called preventable adverse events – an adverse event is an injury resulting from a medical intervention. For example, by some estimates nearly one-third of adverse drug events among outpatients can be prevented.

However, it is important to distinguish a medical error from a lapse or a slip that occurs when an action is not what was originally intended. That can be described as being an error of execution. However, it is crucial to note that a slip or lapse is not necessarily minor or unimportant because patients can die from them. In contrast, there is an error of planning when an action does not achieve the outcome that was intended because the intended action was mistaken.

An additional distinction needs to be drawn between latent errors and active errors. With regard to active errors, they typically occur with operators at the front line where they intersect with patients. As a result, the effects of active errors are immediate. With regard to latent errors, they typically are distant from an operator’s control reﬂecting poor design in a system. There is a shift in discourse about medical error from focusing on the clinician who enacts an error (active error) to underlying systems that create an environment where an error can occur (latent error). This shift emphasizes that the greatest threat to a patient’s safety must be associated with systems. It is understandable why a standard response to a medical error focuses on active errors as being enacted by a speciﬁc clinician. Nonetheless, it is now widely understood that the failure of systems is much more critical insofar as medical errors tend to be linked with latent failures. In other words, creating safe systems in the healthcare environment requires a focus on latent errors as system failures. At the heart of this approach is the recognition that a system is a set of interdependent elements interacting to achieve a common aim (Zipperer 2014).

This approach to error that focuses on reviewing and designing underlying systems to support safety has been extraordinarily successful in other industries. For example, there is a safety paradigm in the airline industry that can shed light on the importance of a systems approach to error and safety. Civilian airlines adopt a comprehensive approach to ﬂight and passenger safety. They insist upon a variety of related interventions including the following: accident investigations and incident reporting, meticulous recordkeeping, mandatory standards for safety, training programs, data safety and monitoring boards, and research for continuous quality improvement. As a result, a variety of regulatory bodies have been developed in different countries across the world to provide oversight for the safety of civilian ﬂights. Also, a crucial component in the success of noticeably increased ﬂight safety has been the establishment of a process for conﬁdential incident reporting. By freeing civilian airlines from regulatory reprisals for reporting pilot error and near misses, pilot cooperation has soared and enhanced passenger safety has resulted. This safety paradigm can be applied to healthcare by shifting from focusing on individual culpability for error to emphasizing organizational systems for patient safety.

Individual Culpability Versus Organizational Systems

Efforts to reduce medical error in the past highlighted the individual culpability of a clinician for the mistake. The individual clinician was blamed for the medical error and punished in an effort to prevent future recurrence either by the guilty individual or by others. This was known as the professional sanctions model. The reactive model dwelt upon who was responsible for the error, accusing a professional of carelessness or incompetence, rather than trying to clarify what precisely caused the mistake. This model relied upon establishing a climate of fear and shame to deter individuals from making mistakes. Not surprisingly, this approach generated a tendency to cover up errors and a failure to report them, thereby escalating the problem rather than diminishing it. The failure of this model is widely recognized insofar as it was unable to reduce the extent of medical errors. A different model was urgently needed to more effectively deal with avoiding medical error and promoting patient safety.

The model that has made much more effective progress to diminish error and enhance safety is known as the patient safety model. This requires an understanding of the connection between risk management, quality improvement, and patient safety (Dekker 2011). The patient safety model seeks changes in the systems and processes that create the environment in which practices occur that cause individuals to make medical mistakes. The purpose is to identify exactly what occurred in a medical error, getting to the root cause of the problem, in order to implement safeguards in the underlying systems and processes that will prevent recurrence. This proactive organizational approach to the problem of medical error encourages reporting of error to remedy the system glitches that cause it and thereby lead to signiﬁcant quality improvement of patient care. At the core of this proactive and positive model is what is known as root cause analysis whereby the underlying causes of the mistake are identiﬁed to prevent recurrence.

Root Cause Analysis

The purpose of root cause analysis is to reduce medical error and foster patient safety by identifying the precise cause of error and by preventing system failures (Joint Commission 2003, 2012). This undertaking enables healthcare to adopt a proactive approach that focuses on the underlying systems and processes rather than a reactive approach that concentrates on the personal performance of an individual professional to assign blame for error. In other words, identifying the causal factors of an error is what matters. Part of the vocabulary associated with root cause analysis is that of sentinel events – here, the term “sentinel” indicates an unexpected occurrence or risk that requires immediate investigation. However, sentinel events are not the same as medical errors: not all sentinel events result from a medical error (Joint Commission 2008). By adopting a systems approach rather than focusing on individuals, root cause analysis focuses primarily on organizational processes rather than on personal performance. Hence, a successful root cause analysis does not assign blame, but enables a team to understand the causes or potential causes of medical error and the required changes that are likely to prevent their recurrence.

Generally, a root cause analysis of a sentinel event clariﬁes the systemic underpinning of a problem to diminish medical error and improve patient safety (Wachter 2012). This involves a variety of interrelated steps, including the following: identifying risk reduction strategies; designing, seeking consensus around, and implementing improvements to the systems and processes underlying the problem; developing outcome measures for continuous improvement in the quality of care; and reporting the results in a public manner.

More particularly, the process of root cause analysis has very speciﬁc steps that should be followed to maximize the reduction of medical error and the enhancement of patient safety. Before any sentinel event occurs, the healthcare institution should create an environment that is conducive to pursuing a root cause analysis in order to improve patient safety. This means that the healthcare institution should provide sufﬁcient resources to ensure that a reliable investigation can occur in a timely manner when required. When a sentinel event is reported, a team should be assigned to assess the event as an undertaking that is designed to be objective and fair.

The focus should be on risk reduction by considering systems and processes and not upon blame assignment by accusing individual professionals. The problem should be studied in a comprehensive manner beginning with a precise account of the criteria being used and an accurate description of what occurred or what nearly happened – sentinel events include medical errors and near misses, so to speak. The data should be gathered and recorded meticulously and in a manner that safeguards data protection as well as patient conﬁdentiality. An example of the processes involved in undertaking a root cause analysis and a summary of sentinel event data in the USA for 2014 can be found on the website of the organization that accredits hospitals, The Joint Commission (http://www.jointcommission.org/ sentinel_event.aspx).

Safety Culture

Insofar as root cause analysis reﬂects the basic shift from individual culpability to focusing on organizational systems, this dynamic new approach provides a robust and ﬂexible instrument to foster a culture of patient safety in healthcare organizations (Wachter 2012). Several ethical guidelines can be identiﬁed to develop an organizational culture that seeks to reduce medical error and promote patient safety as healthcare priorities.

Leadership is required across the healthcare organization to develop a culture of safety. Here leadership includes clinicians, executives, and boards of directors as an organizational responsibility (Youngberg 2012). This leadership commitment requires a dynamic vision to advance the quality of patient care in which patient safety is a priority objective for the institution. This commitment also requires appropriate allocation of resources – these are needed to ensure effective team functioning for safety-related processes (recognizing that there tend to be fewer errors when team work is involved) and to establish clear oversight for patient safety within the organization. These processes include root cause analysis of sentinel events to identify actual and potential risks, to reduce the number and severity of adverse outcomes, and to support systems redesign as needed.

Effective leadership is manifest in fostering a learning environment across the organization that includes everyone in the endeavor to promote patient safety. There are several crucial components that are needed to develop a robust learning environment for patient safety. Training must be provided to encourage open communication to report sentinel events and to provide feedback from errors not only to explain why they occurred but also to implement improvement mechanisms and to track changes for effectiveness.

Effective leadership and a robust learning environment must acknowledge that human limits are inherent to any design process. Because of the inherent limitations that humans bring to any process that involves patient safety, it is crucial to avoid reliance on memory and on vigilance because each can be prone to serious compromise. To avoid reliance of memory, protocols and checklists should be designed and adopted. An example is the civilian airline industry where pilots of the aircraft work through checklists meticulously as they prepare for the ﬂight. Reliance on vigilance should be avoided because of the limited nature of the human attention span – our brains are not computers. Hence, key processes should be simpliﬁed to minimize problem solving and reduce the likelihood of error; and work processes should be standardized enabling personnel to work safely. In addition to concerns with memory and vigilance, jobs should be designed with safety as the priority such as giving attention to work hours and assignment loads, stafﬁng ratios, fatigue, or sleep deprivation. Also, being conscious of safety in the workplace should encourage the use of constraints and nudging functions to guide users to the next action or decision.

While safety design in the workplace is indispensable for a safety culture, the organization also needs to be continuously watchful in the sense of anticipating the unexpected. This attentiveness requires a proactive mindset that has two interrelated features. There needs to be an ongoing scrutiny of systems and processes to antecedently detect potential threats to safety. There also needs to be an ongoing design and redesign of systems and processes both to avoid accidents (such as by automating tasks that are repetitive, time consuming, and error prone) and to recover from accidents (such as by making errors visible when possible and making it easy to reverse operations).

Because of the pivotal signiﬁcance of developing a culture of patient safety across healthcare organizations to diminish medical error, it is indispensable that accrediting processes for healthcare insist on this matter. In many countries this has led to the development of national patient safety goals that healthcare organizations are expected to achieve. Naturally, as more goals (e.g., for hospital care or for long-term care) are achieved each year, patient safety will be enhanced signiﬁcantly (for an example, see http://www.jointcommission. org/standards_information/npsgs.aspx). These goals can be connected with the extensive variety of speciﬁc cases of medical error to develop basic competencies in patient safety (Johnson et al. 2015).

Conclusion

As progress on patient safety continues, organizational ethics seeks to encourage two new approaches: a compensation approach and a central reporting approach. If these gain widespread appeal, they will considerably enhance the agenda for patient safety. Talking with patients and families about medical error and injury is not an easy undertaking (Truog et al. 2011). However, the endeavor can become more productive in the context of an apology and compensation, especially if healthcare can give assurances that better reporting mechanisms are being developed.

On the one hand, there needs to be better systems to establish fair resolutions or settlements regarding medical errors. One widely acknowledged approach is for organizations to assume responsibility. This approach is called no-fault compensation. Here, compensation is provided to the victims of medical error without the organization accepting culpability or fault. This approach receives signiﬁcant attention as an alternative to undertaking expensive lawsuits (Wachter 2012). These medical malpractice lawsuits occur in different ways in different jurisdictions around the world. In this compensation approach, healthcare providers adopt several measures after a medical error occurs: they explain to the patient (or the patient’s representatives) the mistake’s details and offer an apology for the harm done; they explain the interventions that have been put in place to prevent recurrence with other patients; and they offer compensation for the pain and suffering involved.

On the other hand, there needs to be better mechanisms for reporting medical error within institutions, between organizations, and across each nation. This will require a centralized system that mandates reporting of medical errors at a national level, preferably with conﬁdential reporting systems included. If that data can be accrued in a reliable manner, the public will have a better sense of the problem and healthcare systems globally will be help more accountable for patient safety.

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