Risk, safety, and reliability. From cult to culture?

As we move into the second quarter of 2009, the safety and reliability of healthcare has become a hot topic and a top priority. And rightly so, since unsafe healthcare creates an unacceptable ‘double whammy’ effect. Firstly, it permanently damages lives and may even be lethal, and secondly it wastes scarce health care resources at an alarming rate. Moreover, with central bankers worldwide using public money to bail out broken financial systems, and some governments doing the same for bankrupt industries, there simply isn’t money to waste on unsafe health care practice anymore. Just as financial and industrial sectors in the global economy are facing severe challenges, so is health care, which must respond to become safe, effective, fairly distributed, and sustainable. The aim of this special edition is to provide readers with stimulating and thought-provoking papers addressing major theory and practice issues in patient safety, healthcare risk and reliability. Risk and safety have risen to prominence in healthcare relatively recently, within the last two decades, moving from a marginal, almost, ‘cult’ issue to international concern about patient safety culture. Reliability theory is the most recent addition to healthcare, emerging over the past 5 years. The complex clinical issues, and their theoretical, methodological and practical dimensions span acute and community healthcare settings, individuals and organizations, and macro- meso- and micro-levels. Each paper not only provides essential information to assist nurse managers and leaders in maintaining safe practice, but also connects with the other articles. We hope our authors, many of whom are nationally and internationally recognized as key contributors in the field, point the way towards solving these difficult issues. Moreover, as we move forward, published feedback from readers on this key topic is an important part of the debate, and very welcome, ranging from a 200-word letter upwards. The papers are presented in three sub-sections: patient safety, healthcare risk, and reliability. These explore the epidemiology of safety and risk, measuring risk and safety culture, management strategies, economics and education, and consider the underpinning theories and research. Initially, we considered having regulation as a major theme for discussion, but decided against this because much had already been published on the subject, and we felt that the rapidly emerging, progressive theme of reliability theory offered better potential. Some articles in this themed issue have been designated as free online, meaning that non-subscribers can access them, with our complements. Quality, safety, and reliability levels in health care are not as high as they should be, and this is a fundamental concern to patients, healthcare practitioners, managers and policy-makers at all stages of the patient journey. Quality and safety vary and, despite the best intentions of the majority of healthcare practitioners, sub-optimal care is common, with unintended patient harm occurring frequently throughout the system. Reliability theory seems thinly applied with few centres of excellence. Nursing and nursing management have a primary role in ensuring patient safety. As in many other areas, nurse managers need to take a strong leadership role in implementing change, evaluating costs and benefits rigourously. Evidence demonstrating the importance of nursing in patient care quality and safety is increasing. In 1999 the Institute of Medicine (USA) identified the importance of healthcare system design and interprofessional teamwork ( Institute of Medicine 1999). Their subsequent report ‘To err is human: building a safer health system’ (IoM 2000) first identified patient safety errors as a policy and practice priority. The IOM later highlighted the role of nurses in patient safety (IoM 2004). Much earlier, Leape (1994) identified that nursing’s frontline presence and vigilance protects patients from errors. Meanwhile, Aiken et al.’s (2002) research linked higher numbers of patient deaths with fewer nurses providing care, and Needleman et al. (2002), Needleman & Buerhaus (2003) found higher rates of complications associated with reduced nursing time spent on actual patient care. In the UK the Department of Health Report: ‘An Organization with a Memory’ (DoH 2000) emphasized the need for organizational learning from ‘adverse incidents’ and ‘near misses’ in the NHS. The aim was to change the NHS organizational safety culture from a ‘blame’ culture to an open, learning culture. ‘Building a Safer NHS for Patients’ (DoH 2001) recommended the NHS ‘modernize’ its approach to dealing with adverse events, and created The National Patient Safety Agency (NPSA) with the remit to promote patient safety and organizational learning, and establish and manage The National Incident Reporting System. ‘Building a Safer NHS for Patients’ (DoH 2001) also identified the important role of education and training in creating positive learning environments and open learning organizational cultures. The National Health Service Confederation Report (2003)‘Creating the virtuous circle: patient safety, accountability and an open and fair culture’ advised that patient safety should be included in all courses. Educators were encouraged to promote and teach skills that are crucial to patient safety: interaction, leadership, teamwork and communication. However, evidence about how patient safety is addressed in healthcare professional education and how organizations develop safe healthcare practitioners remains limited. Risk, error, adverse events, and critical incidents are omnipresent, and undermine safety and quality. Healthcare is especially high-risk, if it uses complex systems which rely heavily on humans, to effect critical decisions in high pressure environments. The difficulty is that before errors can be minimized, the latent risk factors must be identified and managed. Responses to risk should be proactive rather than reactive; identifying and managing them before they impact adversely on individuals or organizations. However, risk prevention remains the ideal. Robust risk assessment and management policies have become a key component of organizational governance at all levels, and thus an everyday part of management practice. Organizations which succeed at this generate improved care quality, safety, efficiency and reliability, as well as reduced costs. In normal times, this may yield a competitive advantage under prospective reimbursement. In austerity it could be make-or-break. Debates about whether risk is more or less prevalent in contemporary society continue. The perception of risk and beliefs about its causation and prevalence are important as they drive how risk is defined, assessed and managed. Traditional approaches treat safety problems and errors as individual failings, caused by inadequate knowledge or skills. This ‘bad apple’ theory involves naming, blaming, shaming, retraining, and possibly dismissing individuals. Individual risk can be managed by standardization, mechanization and tight control over processes. Yet in health care, as the seven steps to patient safety document (NPSA 2003) suggests, the reality is different. The traditional approach fails in a number of crucial areas (NPSA 2003): failing to take account of systems and complexity; failing to acknowledge the high-risk, error-prone nature of organizational activities; failing to facilitate the open reporting of errors and near-misses; failing to analyse errors and their causation; and failing to learn from mistakes. So in order to analyse risk and safety management, it is necessary to first clarify its nature, scale and scope. The papers in the risk sub-theme cover the epidemiology of adverse events in healthcare (Brady et al. 2009), the nature of risk/safety problems in home care residents in Canada (Doran et al. 2009), the risks of adverse drug reactions in Wales (Jordan et al. 2009) and risks during medication administration in Italy (Palese et al. 2009). It would be wrong to assume that these risks are exclusively the concern of healthcare organizations, managers and nurses in these countries. As Brady et al. (2009) show us, adverse events are universal phenomena, about which we have much more to learn. Doran et al. (2009) explore the epidemiology of safety and risk in a secondary data set of nursing home residents in Canada, comparing their results to recent similar studies, and finding that new falls, unintended weight loss, new emergency room and hospital visits, and urinary tract infections were the most prevalent adverse events. These methods and data make a useful contribution to the evidence, and help managers first identify potential safety risks, and subsequently manage them. To highlight the contribution that Doran’s study makes to this debate, we have made access to this paper free online. In the mental health setting, Jordan et al. (2009) examine the electronic records of clients in crisis home resolution teams, for evidence of monitoring potential adverse drug reactions. Their findings suggest that important aspects of medication monitoring are omitted, and that in future, improved electronic records should be used. They propose the West Wales Adverse Drug Reaction profile as one possible strategy for this. In this respect, Jordan et al.’s paper could equally well belong to the safety section of this issue. Turning to inpatient care, one of the most common and important routines is the medication administration round, and medication errors are a real threat to patient safety. The observational study by Palese et al. (2009), during drug rounds in seven Italian surgical wards, suggests that interruptions are very common, with telephone interruptions a particular risk to drug round safety. These authors suggest that many of the avoidable interruptions relate to work organization, and could be changed create a safer, undisturbed environment for drug administration. Developing a culture of healthcare safety is a global priority, and strategies for achieving this include the adoption of a systems approach (Reason 2000) and open reporting, where adverse events are reported, analysed and learned from (NPSA 2003). Safety culture refers to a commitment to safety that pervades the entire organization, from frontline staff to executive management. Healthcare systems are focusing explicitly on developing a culture of patient safety that will enable risk to be managed more effectively. The papers by Gerry Armitage, Beverley Norris and Emma Boakes explore theories underpinning this crucial area, offering practical solutions to promoting safety and reducing or eradicating risk and error. Armitage (2009) critiques human error theory and applies it to nursing management. Norris (2009) complements this, by examining the ergonomic case for human factors and safe patient care, and explaining how human factors research can be used to improve patient safety. Boakes (2009) short report shows how the NPSA’s Foresight training applies human factors research, to improve the safety of nursing care with this prospective risk assessment technique. Understanding the complexity of patient safety culture is essential before it can be managed and improved. This abstract construct cannot be measured directly, and must be inferred from behaviours. The Manchester Patient Safety Framework (MaPSaF 2006) provides a useful framework for the measurement and improvement of patient safety culture across a range of clinical settings. Dianne Parkers’ short report outlines the key features of MaPSaF, which is a tool nurse managers can use to understand, assess, and then improve safety culture in their place of work (Parker 2009). As highlighted earlier, a pervasive ‘blame culture’ impedes acknowledgment of error, and ‘professional “silos”’ offer resistance to changing any universal aspect of health care, including culture. The papers in this section, provide knowledge that will help nurse managers do this and improve safety for patients and staff. In this respect, only the brave or foolish would argue against improving healthcare safety. However, the level and quality of evidence needs to be improved, which is a massive international challenge. Rebecca Warburton begins to address this challenge, by asking the key question, ‘how much safety is enough?’ With limited resources, tough decisions may have to be made. Cost effectiveness is very influential in other areas of health research and, as safety researchers and providers move beyond the early adoption phase, this method may go some way towards providing an answer. Paradoxically, applying strict cost effectiveness criteria would mean that many of the useful safety interventions written about here might not be recommended (Warburton 2009). Two main methodological recommendations are made. Firstly, use of an iterative cost effectiveness methodology in an ‘economic evaluation loop’, and secondly the iterative use of Plan-Do-Study-Act (PDSA) cycles as part of local models for improvement. These methods are very powerful, and perhaps even identifying where the diminishing returns to safety implementation start to bite. The relationship between patient and staff safety is important, but has had little in-depth empirical study hitherto. To remedy this, Smith et al. (2009) link emotions at work not only to patient and staff safety, but also to the important wider issues of patient safety culture, governance, and education for patient safety. The need for emotionally intelligent and supportive nursing management is highlighted in this study, and education is in turn seen as an imperative to achieve this. In his discussion of reliability theory, Bill Riley suggests that Perrow’s (1984, 1994) concept of complexity and tight coupling (where harm follows immediately or very soon after an adverse event), create the need for increased healthcare reliability. In another paradox, the very success of health care in terms of more technological treatments, is part of the problem because it increases complexity, perhaps beyond the capability of the human factors discussed in earlier papers to deal with. Interdisciplinary team training and process design are highlighted as two essential components of reliable health care, and the extent to which these techniques are currently used is a matter for debate. According to Riley (2009), nurses fit very well into the mainstream safety paradigm, because their vigilance in practice serves as an important defence against latent conditions and active failures highlighted by Leape (1994), Reason (2000) and many others. However, as well as being part of the solution, nurses may also be part of the problem, because they themselves may make errors or violate procedures, especially if staffing levels or morale are low. Riley moves on to consider the nature of effective health care teams, and methods to train them, suggesting ‘in-situ simulation’ and ‘rapid cycle correction’ as promising approaches. Turning to process design, important suggestions are made about how to modify the health care production process towards improvement. These include the care bundle approach, which is becoming increasingly prominent in intensive and high dependency care, combined with statistical process control (SPC) involving: process maps; control charts; and a model for improvement based on the iterative use of PDSA. Interestingly, there are very close parallels between this and the economic approach discussed earlier by Warburton, and we feel there may ultimately be convergence between them as part of the same toolkit. To finish, Riley makes five strong recommendations for nurse leaders who want to enhance the reliability of their own system or unit. We also made access to this paper free online. Complementary to the Riley paper, Kristi Miller and colleagues provide evidence of how simulation techniques can be used to identify key behavioural markers in interdisciplinary interaction. Their study identifies four important components of this: situational awareness; closed loop communication; situation-background-assessment-recommendation-response (SBAR-R); and a shared mental model of events. Not only are these essential components of teamwork, but readers should note they are also crucial parts of reliability theory and, if consistently applied, a fundamental part of safety culture (but not the only part). Using in-situ simulation techniques, and scenarios based on actual critical incidents, Miller et al. (2009) found that that these behaviours were not consistently observed. This suggests that more educational effort is needed to instil these reliability competencies into practitioner behaviour, if a safety culture is to take hold in service provision. Staying with this theme, Hannah Cooke provides us with a critical perspective on the use of reliability theory in health care, comparing Perrow’s original concept of normal accident theory, high reliability theory as currently adapted to health care, and an anthropological approach known as grid-group cultural theory. Perrow’s theory suggests accidents are inevitable and in some respects ‘normal’, where tight coupling and complexity occur. Grid-group theory proposes looser coupling and making organization less complex and more ‘linear’. To Cooke (2009), reliability theory is considered a top-down managerial approach to introducing safety culture, and thus of limited potential, because the actual culture that evolves may be more due to bottom-up factors. As an interesting aside, the analysis implies that complexity and tight coupling appear grafted into reliability theory from their original use by Perrow. The strength of reliability theory is seen as being in its potential to create organizational learning. However, grid-group theory is offered as a more bottom-up perspective approach to service culture, where ‘grid’ (relating to the rules and hierarchy) interacts with ‘group’ (the degree of social cohesion) to produce four stable cultural subsets. These form a useful framework to consider the meaning of risk within an organization, which in turn permits managers to select appropriate management strategies. Nurse staffing levels are a key feature of the health care safety debate, and so we asked eminent nursing workforce and safety scholar Sean Clarke to comment on how these areas have evolved and, more importantly, where they are headed. Using the language of metaphor, he describes how workforce research programmes evolved pragmatically, in ways least disruptive to practice yet large enough to generate meaningful data. Using (at the behest of funders) what appeared to be the least helpful variables, these studies yielded associations strong enough to inform and underpin changes to policy and law. The full story is told, in true docu-drama style, by Gordon et al. (2008). Even Arnold Schwarzenegger gets in on the act- although apparently not the good guy this time. We have made access to this commentary free online and the book is reviewed in this issue of JNM (see p. 265). So, will the future be like the past for safety and staffing research? As Clarke (2009) suggests in his ice hockey analogy, if we return to where we think the puck is, we may well have missed it, losing our hard-won positional advantages because the game has moved on. Perhaps we should build on previous studies rather than merely repeat them, with detailed exploration of the interaction of financial, workforce and safety issues closer to the shop floor, combined with the PDSA approach. Mainstream production economics techniques may be used for the bigger studies, along with the iterative cost-effectiveness methods discussed in this issue. However, good studies are necessary but not sufficient. Ruthless process redesign and organizational learning are also needed to overhaul expensive, unreliable and outmoded ways of working and thinking. Risk management, human factors, workforce, safety culture, emotional labour, finance, reliability theory. These diverse research programmes each grapple with part of the same latent construct – the best service delivery paradigm. But, like the blind men in Clarke’s commentary, we cannot say fully what it is yet. In order to address the core issues in health care delivery-safety included – future efforts must work beyond the range of solitary programmes, and establish convergence between them. This will help establish a safe and sustainable health care delivery paradigm for the future (Newbold 2008). Unsafe health care harms people and wastes resources. As Warburton (2009) suggests in this issue: ‘…reducing waste will make it possible to provide needed medical care to all… without costs spiralling out of control’. Because of this, we believe reliable, safe health care should become an integral part of healthcare service culture as soon as possible. The global financial situation suggests it cannot wait that long.