Concern for the safety of patients has always been part of the practice and organization of medicine. The obligation of doctors to consider the risk of intervention and the safety of patients was present in the Hippocratic corpus of writings and has been an integral part of teaching medicine and regulating medical misconduct since antiquity. Today, the well-known axiom âabove all, do no harmâ (in Latin primum non nocere) is, in spite of its contested origin, understood as a cornerstone in medical codes of conduct. This ethical norm of non-maleficence is taught in medical schools throughout the world not so much as a rigid rule or a fundamental principle, but as a symbol of sound clinical judgement (Brewin 1994) and as a reminder that all clinical activity carries the potential for harm (Smith 2005). In this way, the norm of non-maleficence is integral to the ethical formation of medical students, where learning to become a doctor involves the ability to practise medicine in the face of fallibility and uncertainty. It involves the inculcation of the fact that as a clinician your decisions and actions might cause harm, disability and death for the patients, regardless of your good intentions (Fox 1957; Paget 1988).
From an organizational and societal perspective, managing medical error and misconduct function as a way to establish the line between acceptable and unacceptable medical practice and office-holding. Internal collegial procedures for detecting, classifying, disciplining or forgiving error have historically been a necessary part of professionally driven processes of social control and of teaching young doctors the standards of medical practice (Bosk 2003 [1979]). Parallel to these internal mechanisms, external and public measures such as depriving doctors their licence to practise medicine andâincreasingly since the 1970sâmalpractice claims and liability suits operate as legal mechanisms for regulating cases of medical negligence or unfitness caused by, for instance, physical and mental disability.
In the last two decades, a new version of patient safetyâthe international patient safety policy programmeâhas emerged with propositions, objectives and consequences that differ fundamentally from the traditional approaches to medical error and error management. In patient safety thinking and practice as it has developed since the early 1990s, patient safety has become a policy problem linked to wider discussions of service delivery in healthcare and to parallel and overlapping healthcare policy agendas such as evidence-based medicine, quality improvement and New Public Managementâinspired ideals of public sector management based on principles of accountability, measurability and risk management. Within the sphere of this new policy approach to patient safety, the purpose of patient safety and error management has radically changed. Error management no longer primarily serves the ethical training and conduct of the medical profession or the legal regulation of medical malpractice. Rather, patient safety policy, technology and ideology are first and foremost to serve the optimization of healthcare systems. Based on a vision of failsafe system design, patient safety and error management have been introduced as optimization and reengineering strategies, where the goal is to create a learning and reporting culture through a blame-free ethos. Here, mishaps, errors and critical incidents are used as catalysts for introducing new types of technological fixes, failsafe devices and standardized protocols, checklists and procedures, all with the ambition of strengthening the system by preventing errors of similar kinds.
The programme has been brought forth through different types of developments of which one concerns a growing awareness of the magnitude of the safety problem in healthcare. Starting with the Harvard Medical Practice Study from 1991, where it was shown that harmful errorâor what was soon to be known as adverse events or critical incidentsâhappened to 4 per cent of hospitalized patients (Brennan et al. 1991; Leape et al. 1991), an emergent public and political concern with the high number of errors and a related questioning of the efficiency and adequacy of the existing internal professional and external jurisdictional error-management strategies helped promote the new policy agenda and its ideal of system optimization. This growing awareness was stimulated by a number of medical error scandals in the USA and Britain of which the Betsy Lehman scandal was of special importance. Lehman was a 39-year-old Boston Globe reporter who during her treatment at the Dana-Faber Cancer Institute in 1994 died from an overdose of chemotherapy. The Lehman case made no less than 28 front-page headlines in the USA in the three years following the incident (Conway and Weingart 2005). Public scandals such as the Lehman case and the rising awareness of the number of medical errors led the way for the success of the seminal American Institute of Medicine report To Err Is Human: Building a Safer Health System (Kohn et al. 2000). The earlier Harvard study came to have immense importance in allowing for the Institute of Medicine report to pose its well-known statement that up to 98,000 Americans die in hospitals each year as a result of medical errors that could have been prevented. Interestingly, however, the preventability theme was not part of the original Harvard study but rather an invention to support the particular âerror-prevention through redesignâ perspective on patient safety that has come to define the policy agenda. Concurrent with the growing popularity of To Err Is Human internationally, the American studies were followed by similar studies in other Western countries (Davis et al. 2002; Schiøler et al. 2001; Vincent et al. 2001; Wilson et al. 1995; Baker et al. 2004) on the basis of which it wasâand still isâgenerally agreed that approximately every tenth patient experiences a medical error during hospitalization.
A second important reason for the success of the new safety programme is the strong increase in medical malpractice claims. Especially in the USA since the 1970s (Thorpe 2004) but increasingly also in other Western countries, a rising number of cases of malpractice are treated in legal systems created to deal with questions of, on the one hand, compensation and, on the other, intent, personal fitness or neglect in order to determine if the treatment provided falls below the accepted standard. The international patient safety programme can be understood as a way to minimize this problem of medical liability. At the same time, the programme is often perceived as an alternative approach to error management, established on an immanent critique of the legal systemâs difficulties of addressing the distributed agency of medical practices and the cooperational and systemic components of certain types of medical errors. In other words, legal systems have a tendency to put persons and not medical teams, technologies, organizations, management or systems on trial. From this perspective, the current safety agenda has been a way for the medical profession to draw attention to the âsystemicâ components of medical errors. This can partly explain the strong professional support to the patient safety movement that has largely been driven and developed by doctors on the policy and institutional level and by nurses on the organizational level. With the focus on systemic error and the efforts to create âlearning culturesâ in healthcare organizations through blame-free methodologies and rhetorical strategies, the programme can be understood as a professionally led attempt to create a regime for dealing with errors alongside the legal system. This parallel way of managing error has resulted in a new system for internal control through reporting and analysis of incidents, safety audits, retrospect journal reviews and a whole range of standardized safety methodologies and tools, which can be understood as part of a âregulatory epistemologyâ in which internal control and risk management systems represent organizations as trustworthy for the public through production of certain types of evidence (Power 2007: 40). Or, as argued by Jessica Mesman, â[t]he danger to be indicted for malpractice has set in motion an avalanche of numbersâ (2008: 191).
The safety programme and its ideal of system optimization through failsafe organizing are founded on and enacted through a set of basic assumptions about medicine, errors, risk, health professionals and health systems. One assumption concerns medical âcultureâ. It is a dominant trope in mainstream patient safety literature that healthcare organizations are dominated by practices of blaming and shaming, where errors give rise to individual witch hunts and layoffs. The tale of a blame culture is used to promote the need for a blame-free perspective as well as to argue for a systems theoretical view on error management. Another assumption concerns the possibility of risk elimination. Already with the âpreventabilityâ theme of To Err Is Human (Kohn et al. 2000), it is implied that risk and errors can and should be prevented through appropriate failsafe system design. A third assumption concerns âhuman natureâ. In mainstream patient safety thinking, humans (i.e., health professionals) are established as essentially and permanently error-prone. This proclamation is used to found the argument that safety management should strive to improve systems rather than relying on training and development of appropriate routines, competences and skills of those working in these systems. Lastly, the patient safety programme is based on a quest for certainty and a faith in organizing principles. Today most patient safety technologies are based on the idea that healthcare organizations are relatively stable systems that can become failsafe though standardization and the reduction of practice variance. But also the most dominant of the current alternatives to the mainstream approach, the Resilience or Safety II approach to patient safety, promote a set of organizing principles based on the possibility of predetermining the main characteristics of healthcare settings (Hollnagel et al. 2013, 2015; Braithwaite et al. 2015).
In this book, I inquire into these four assumptions of the patient safety programme; I investigate the particular ways they are enacted in healthcare; I challenge them one by one; and I develop a pragmatic stance on patient safety that takes its point of departure in the concrete clinical situations and pragmatic clinical practices in which patient safety is enacted based on a complex combination of trained and internalized safety dispositions, practical types of reasoning, well-founded routines and skills, ethical attitudes, thoroughly rehearsed teamwork as well as guidelines, protocols and technologies. By proposing a case-based and situated way into safety, the book offers an alternative vocabulary for understanding and approaching safety and risk management in healthcare particularly and in public sector institutions more generally. Moreover, it would seem that these findings and the presented pragmatic approach are not only of relevance for safety and risk managementâbut more generally for contemporary management thinking where centralized and standardized system improvements are often presupposed as the ârightâ solutions to various organizational problems.
In the remainder of this introduction, I present the programme as an international movement and as a study object, I familiarize the reader with the empirical context for the studies of medical practices and safety technologies on which the book is founded, and I introduce the pragmatic stance that informs it.
An International Movement
The patient safety policy agenda and its quest to create failsafe organizations through system optimization is an international phenomenon. Patient safety has become institutionalized in the Western world at large, and increasingly in developing countries as well. This process has occurred through massive coordinated efforts originating from international agencies and dominant national players, mainly American. The World Health Organization (WHO) has, since the launch of The World Alliance for Patient Safety (WHO 2004), been an important player in this institutionalization by explicitly aiming âto coordinate, disseminate and accelerate improvements in patient safety worldwideâ.1 Today, WHO stands behind, amongst other initiatives, the development and spread of various global campaigns, training programmes, global focus areas such as infections, safe surgery and patient involvement; guidelines and manuals for reporting systems and other safety technologies; and checklists for hand hygiene, surgery, childbirth, trauma and much more. Other important governmental as well as non-governmental global players include the American Institute of Medicine, which set the agenda with To Err Is Human (Kohn et al. 2000); the American Institute for Healthcare Improvement (IHI), which plays a major part in innovating and disseminating...