The pursuit of safety is not for the timid. This Health Foundation report eloquently surveys the landscape of obstacles. But there are at least two inescapable facts that make improving safety especially difficult and frustrating.

First, securing safety is a task that cannot be ‘finished’, ever. As Professor James Reason puts it: ‘Safety is a continually emerging property of a complex system.’ The threats to safety flow like an endless game on a football field, in which no two patterns and no two moments are ever the same. Linear thinking – the search for simple, single causes – is doomed. All modern approaches to achieving safety (or reliability, for that matter) require continual attention to adjustments, resilience, adaptation and local contexts.

It is so tempting, especially in politicised contexts, to try for simple answers, to ‘plug in’ safety like one plugs in a toaster. Certainly, there are techniques that can help. Checklists, monitoring devices, transparent metrics, standardised processes – these and many other mechanics have proven their worth in the right context at the right time. But, fundamentally, the quest for the installable ‘fix’ is doomed. The most important cultural characteristic of the safest enterprises is not that they have the right technical features in place (although they should), but rather that they are full of people at all levels who can sense, change, adapt and change again in response to the ever-changing terrain of threat and challenge – and are supported by their leaders to do so. Indeed, in that sense, safer systems are safer because they are never the same twice. That’s what James Reason means by ‘a continually emerging property’.

Second, the pursuit of safety depends on volunteerism. It is more about what people choose to do than about what they are required to do. Safety cannot, in any meaningful sense, be required of a workforce or, for that matter, of those they serve. For leaders, this means that their job is continually to try to build on and support intrinsic motivation.

For understandable reasons, the temptation to depend on rules and requirements is seductive. For one thing, it’s a lot easier. For another, organisations and societies obviously do need rules. We don’t want roads without speed limits, electrical plugs without grounding, or mains water with harmful germs. But René Amalberti et al emphasise the importance of distinguishing between (and acting differently on) ‘extreme violations’ (which are rare and intolerable) and ‘borderline tolerated conditions of use’ (which are pervasive, inevitable, and often wise and informative violations of rules).

Similarly, Karl Weick has clearly elucidated the properties of very safe, ‘high reliability organisations’ (HROs), and strongly emphasises the crucial capacity of ‘sensemaking’ in achieving their results. Understanding and honouring these behavioural and cultural elements of what I might call ‘deep’ safety – as opposed to ‘compliant’ safety or ‘looking good’ safety – demands a level of maturity and psychological sophistication that are too often simply not in the repertoire of an organisation, a leadership system, or a political economy.

It is for this reason that the National Advisory Group on the Safety of Patients in England, which it was my honour to chair, determined that culture will trump rules. That is not a soft idea; it is one grounded in evidence and safety science.

This report from the Health Foundation could be a landmark. Carefully studied and thoroughly acted on, it could mark a shift in the maturity of the safety movement, at least in the UK. It could signal a change from a movement that has been, with all good intention, too tethered to rules and requirements as the anchors for patient safety, to one far better informed by the scientific insights of Amalberti, Reason, Weick, Vincent and others who have been trying to teach us to eschew simple mechanics and embrace the pursuit of safety in all its subtle but nonetheless powerful human dimensions.

Above all else, the key lesson seems to be this: seeking safety raises the question ‘How do we want to be?’ far more emphatically than the question ‘What do we want to require?’ A rule-bound organisation cannot be truly safe. That requires things more important than rules: things like maturity, curiosity, dialogue, daylight, reflection, teamwork, hope and trust. It’s a tougher job for leaders than simply writing and enforcing rules. The difference is, it works.

Donald M. Berwick, MD

President Emeritus and Senior Fellow, Institute for Healthcare Improvement

This report makes the case for changing the way patient safety is approached in the NHS. It argues that change is needed in: how safety is understood, because current approaches to measurement don’t provide the full picture; how safety is improved, because existing approaches alone will not address the most intractable problems; how risk is perceived, because comfort-seeking behaviours will not create a genuine culture of learning.

The patient safety movement is now at a critical moment; to sustain momentum, there has to be recognition that things can – and should – be better.

There have been some remarkable successes in recent years to improve patient safety and tackle harm, and front-line teams supported by the Health Foundation have been an important part of these efforts (see pages 6-7 for examples of some of our current work). This report brings together what we have learned from this work, and also highlights some salutary lessons about the state of patient safety in the NHS and the complex task of continually trying to improve it.

We have learned that many systems are not designed with safety in mind, meaning that it is only the skill and resilience of health care professionals that prevents many more episodes of harm. We have learned that many care processes are unreliable, which can mean that the right equipment isn’t available in theatre, or the wrong drug is given to a patient. We have learned that many institutions don’t have a complete picture of safety, because they focus largely on past events rather than current or future risks. We have learned that there are some common factors that have repeatedly contributed to large-scale failings, but that these factors have consistently not been addressed.

Despite the many successful quality improvement projects the Health Foundation has supported, there have been many more that haven’t delivered the expected benefits. We are only now coming to fully understand the reasons for this. For instance, front-line teams consistently come up against ‘big and hairy’ issues such as inadequate information technology, inconsistent staffing and challenging established cultures. Yet these issues are far beyond the scope of individual teams, and the scope of quality improvement methods alone, to address. If the most intractable safety problems require nationally coordinated solutions, then existing approaches will not yield the future gains that patients and the public expect.

So what might safer care look like in the future?

In our view, a safer care system is conceived from the perspective of the patient, following his or her journey through different care settings, irrespective of organisational boundaries. It is networked, so that successes and failures identified in one part of the system can be readily accessed, understood and built on in another. And it is judged not by the prevalence of adverse events, but by the ability to proactively identify hazards and risks before they harm patients.

How can we get there?

• The journey must begin with practical improvements, based on what is known to work. This report presents a checklist for safety improvement, based on our experience of supporting NHS teams to improve safety. The checklist should be used by front-line teams and organisations when addressing their most pressing safety problems. (See page 28.)
• Improvements to safety on the ground can only be successful with the support of senior leaders in provider organisations. This report sets out the three vital steps that senior leaders should take to create an environment where safety improvement can flourish. (See page 29.)
• The practice and policy of safety improvement are inextricably linked, reflecting recognition that the design of the wider system can support, and hinder, the efforts of front-line staff and senior leaders. This report sets out our vision for an effective system for safety improvement. (See page 34.)

Underpinning everything is the need to approach the work with trust, sincerity and openness. Local improvements in safety won’t be successful if they are not applied faithfully, just as national improvements in safety won’t be achieved if they become subverted into measures of accountability. These are the core lessons we have learned over the past decade; this report draws on them to make the case for why and how future improvements in safety can be realised.

For more details about the ful range of the Foundation's past and present work on patient safety, please visit: www.health.org.uk/theme/patient-safety

Over the past decade, the Health Foundation has supported and funded thousands of people working in different settings, from hospitals to care homes, to develop and test approaches to making care safer. We have learned about some of the specific causes of harm, and which problems can be addressed by front-line teams using quality improvement methods. The many successes should be cause for celebration. They have played their part in dramatically reducing the number of patients harmed by safety problems. However, there is also cause for impatience. We still do not really understand why even highly successful projects do not spread at the speed many would expect; and solutions to the bigger, system-wide challenges remain few and far between.

This report synthesises the lessons from the Health Foundation’s work on improving patient safety over the past decade. Part I illustrates why improving safety is so difficult and complex, and why current approaches need to change. Part II looks at some of the work being done to improve safety and offers examples and insights to support practical improvements in patient safety. In Part III, the report explains why the system needs to think differently about safety, giving policymakers an insight into how their actions can create an environment where continuous safety improvement will flourish, as well as how they can help to tackle system-wide problems that hinder local improvement.

The report includes specific resources that we hope will contribute to the next phase of safety improvement in the NHS:

• For people improving safety at the front line, we provide a checklist for safety improvement to be used when developing solutions to safety problems. This checklist is based on our experience of supporting NHS teams to improve safety over the past decade. (See page 28.)
• For leaders of provider organisations, we set out three practical steps that need to be taken to build an organisation-wide approach to continually improving safety. (See page 29.)
• For government, quality regulators and national bodies with a remit for patient safety, we set out our vision for an effective safety system, which current activities and ambitions should be assessed against. This vision is based on what we have learned about the barriers to safety improvement, and what we consider to be the future frontiers for safety in health care. (See page 34.)

The report also includes a series of viewpoints from leading figures in safety improvement, answering the question ‘What is the future of patient safety?’ from their perspective.

Learning from major safety failings

Health care is a hazardous business. It brings together sick patients, complex systems, fallible professionals and advanced technology. It is classed as a ‘safety-critical industry’, where errors or design failures can lead to the loss of life. Terrible recent care failings illustrate the reality of these hazards, and the significant challenges involved in trying to address them. As with other safety-critical industries, it is imperative that when failures do occur, lessons are learned and action is taken to prevent the same issues reoccurring. As to whether or not this is happening, history tells a different story.

Take the following list of factors, identified in the 2001 Bristol Royal Infirmary Inquiry into the deaths of babies undergoing heart surgery:

• Isolation – in organisational or geographic terms, leaving professionals behind developments elsewhere, unaware or suspicious of new ideas, with no exposure to constructive critical exchange and peer review.
• Inadequate leadership – by managers or clinicians, characterised by a lack of vision, an inability to develop shared or common objectives, a weak or bullying management style, and a reluctance to tackle problems even in the face of extensive evidence.
• System and process failure – where a series of organisational systems and processes were either not present or not working properly, and the checks and balances needed to prevent problems were absent.
• Poor communication – affecting both communication in the health care organisation and between health care professionals and service users, where stakeholders knew something of the problems subsequently identified by an inquiry, but emergence of the full picture in a way that would prompt action was inhibited.
• Disempowerment of staff and service users – where those who might have raised problems or concerns were discouraged from doing so, either because of a sense of helplessness in the face of organisational dysfunction or because the prevailing organisational culture precluded such actions.

The same factors had been cited some 30 years earlier, in the 1969 Ely Hospital Inquiry into long-stay care for older people and people with mental health problems.

The factors are systemic, cultural, contextual and human in nature, and elements of all of them were also identified in the inquiries into failings of care at Mid Staffordshire NHS Foundation Trust and, most recently, Morecambe Bay, some 46 years after the Ely Hospital Inquiry. While such factors are complex, multifaceted and difficult to eradicate, their persistence across the decades is cause for serious concern.

Why is it so difficult to improve safety?

The complex range of factors identified in major care failings also play a central role in the success (or failure) of efforts to improve safety. In 2004, the Health Foundation launched the Safer Patients Initiative – the first major improvement programme to address patient safety in the UK. The programme ultimately helped to raise awareness of the problem of avoidable harm and provide a basis for a wider safety movement. It also began a journey which has deepened our understanding of why improvement programmes often fail to achieve the desired impact. So just why is it so difficult to improve safety? Four key reasons are: complexity, connectedness, context and counting.

Complexity: local improvement interventions cannot solve organisation-wide safety problems

The Safer Patients Initiative focused on improving the reliability of care within four clinical areas across 24 hospitals. A range of improvement interventions were used to tackle problems ranging from central line bloodstream infections to ventilator-associated pneumonia. The aims were a 30% reduction in adverse events and a 15% reduction in mortality, as well as specific goals relating to a range of process and outcome measures.

The independent evaluation of the initiative showed that all sites had improved on at least half of the 43 measures chosen. But many comparison sites that were not participating in the initiative were also improving at the same time owing to a ‘rising tide’, including many concurrent national policy initiatives. The evaluation also showed that the programme failed to become embedded into wider structures and processes, highlighting the scale of resources needed to bring about organisation-wide change.

Connectedness: deceptively simple safety problems often need system-wide solutions

The Safer Clinical Systems programme ran in two phases from 2008 to 2014. In the first phase, the Safer Clinical Systems approach was developed and tested. In the second phase, organisations were supported to try and create systems that were free from unacceptable risk in two areas – clinical handover and the management of medicines. Teams conducted systematic diagnostics on their clinical systems, collecting an array of evidence in order to make a ‘safety case’ about the safety of their service. On the basis of this, the teams chose interventions to address the risks.

Among other lessons, the independent evaluation found that many safety problems were outside the control of individual front-line teams to tackle. These problems often needed to be addressed at the organisation or system-wide level. They included inconsistent staffing, issues with information technology, or challenging established cultures. Although such problems aren’t new to those working in the health service, the evaluation highlighted the degree to which they are entrenched and can stand in the way of local improvement.

Context: the success of safety interventions depends as much on the context in which they are applied as on how well they are carried out

Many safety improvement efforts aim to replicate initiatives that have been successful in other contexts. The Lining Up research project evaluated efforts in England to reproduce the success of the Keystone programme in the US state of Michigan. Keystone had achieved dramatic reductions in bloodstream infections linked to central venous catheters (CVC-BSIs) in intensive care units. The English initiative, known as Matching Michigan, adopted the same interventions, which included technical components (such as the use of chlorhexidine to prepare the patient’s skin) and non-technical components (such as education on the science of safety).

The Lining Up team found that, even where the technical components of an initiative were applied well, a range of contextual factors, including the legacy of previous initiatives, influenced its success. This demonstrated that a programme transplanted from elsewhere does not always work in the same way in the new setting (see also Box 1 overleaf). The team concluded that a deep understanding of why a programme was successful, and how it must be adapted to the local needs and priorities on the ground, was essential.

Counting: assessing safety by what has happened in the past does not give a complete picture of safety now, or in future

The Lining Up research demonstrated that even the seemingly straightforward task of measuring improvements in safety varied so much as to make comparisons between sites ‘almost meaningless’. The challenges of safety measurement were further explored in a 2013 research report by Charles Vincent, Jane Carthey and Susan Burnett, The measurement and monitoring of safety. Their report brought together existing literature and findings of expert interviews and case studies of health care organisations already exploring innovative ways to measure safety. The researchers concluded that, despite the high volume of data collected on medical error and harm to patients, it was still not possible to know how safe care really is, and that assessing safety by what has happened in the past – such as by the number of reported incidents – does not tell us how safe care is now or will be in the near future.

Given the tendency to focus on measuring individual aspects of harm in the NHS, rather than system measures of safety, it is inevitable that an answer to the question of whether the NHS is getting safer remains ‘curiously elusive’.

The state of patient safety in the NHS

Harm caused by health care affects every health system in the world, and the NHS is no exception. Research from the UK and abroad has shown that people admitted to hospital have around a one in 10 chance of being harmed as a result of their care. About half of these episodes of harm are avoidable. We know far less about safety in settings outside of hospital, but research has suggested that around 1–2% of consultations in primary care are associated with an adverse event. The cost of harm – to patients, to those working in health care, and to productivity – is significant. However, creating a health care system that achieves zero avoidable harm is not a realistic ambition.

This is, in part, because understanding of harm – and the types of harm that are avoidable – continues to develop. Problems that were once seen as inevitable consequences of health care (such as some infections) are now seen as both preventable and unacceptable. Other problems, such as medication errors, which appeared in principle to be solvable, have turned out to be much more intractable. Further developments will give greater attention to the psychological aspects of harm, or the harm caused by failing to provide care in a timely way. However, these dimensions of safety are rarely captured through current reporting systems. Therefore, rather than zero avoidable harm, the appropriate ambition should be to continually reduce harm.

So how well is the NHS doing in continually reducing harm? Analysis of some of the measures available nationally shows that, despite some significant achievements, many gaps in knowledge remain. Even where there are measures available, the indicators paint a mixed picture (see Figures 1–13 overleaf). For example:

• People working in the NHS are increasingly willing to report safety incidents (Figure 1). However, just 0.3% of all reported incidents are in primary care, despite 90% of all patient contact taking place there. This suggests significant underreporting of harm in primary care, even taking into account the generally less risky interventions involved.
• There has been great progress in reducing rates of health care associated infections (HCAIs) such as methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile (Figures 4 and 5). However, rates of methicillin-sensitive Staphylococcus aureus (MSSA) and E. coli – which have drawn less political attention – have actually risen (Figures 6 and 7).
• People working in hospitals are more confident that action will be taken following an incident (Figure 8). However, more of them say their organisation has a blame culture (Figure 9).
• More people feel they would be safe if they were treated in hospital (Figure 11). But around 40% of patients feel there aren’t always enough members of staff on duty to care for them (Figure 12).
• In 2014, the Commonwealth Fund ranked the UK as first for safe care out of 11 developed nations. However, in 2014/15, the Care Quality Commission rated 61% of hospital trusts as ‘requires improvement’ and 13% as ‘inadequate’ for safety.

It is clear that things must continue to change. There needs to be recognition of the successes of the past, but also of the limitations of current approaches to improving safety – and the role that policymakers and national bodies can play in fostering improvement. These issues, together with examples of the practical experiences of front-line teams, are explored in parts II and III.

The policy and practice of improving patient safety are inextricably linked. Regulation, guidance, directives and other initiatives can have strong effects on the behaviour of organisations and individuals across the NHS. That is the point, of course. However, it is important to recognise how policy can ‘create the “latent conditions” that increase the risk of failure at the sharp end [as well as] generate organisational contexts that are conducive to providing high quality care’.

In our 2015 report, Constructive comfort: accelerating change in the NHS, we looked at the key factors needed for successful change and explored why they are not consistently present in the NHS. We identified three types of mechanism by which national bodies can effect successful change in the NHS: directing change from the outside; supporting organisations to make change; or seeking to influence the behaviour of individuals. The report concluded that previous efforts, which have largely focused on externally directing change, have had mixed success, and an approach which blends the three mechanisms coherently is likely to be most successful.

In the context of safety improvement, and building on the findings of the Berwick review, this means: ensuring appropriate accountability in rare cases of reckless or neglectful care; creating an environment that works with people’s intrinsic motivations to do good; and harnessing the collective effort to address the issues that make safety improvement so challenging. In this part, we set out how an effective system for safety improvement can be designed to enable these aspirations to become a reality. In doing so, it is important to understand how the current policy approach to patient safety is affecting the NHS.

Perspectives from the NHS

In late 2014, we conducted interviews with 17 NHS board-level leads for patient safety across England. We wanted to understand how the policy and regulatory environment was perceived, and what effect it was having. While many of those we spoke to welcomed the increased national focus on quality and safety, a number of issues were raised. We heard concerns from acute trusts that financial pressures would take precedence over quality in the future, and concerns from mental health, ambulance and community trusts about an excessive focus on acute care. Regulation was generally felt to be moving in a positive direction, however, many of those interviewed were concerned about the resources being absorbed by multiple national reporting lines, and perceived a lack of strong leadership or a coherent push towards safety.

Organisations that had experienced recent problems highlighted particular concerns that close monitoring and scrutiny was hindering long-term planning and progress. Higher-performing organisations told us they want more standardised measurement so that performance can be benchmarked to enable learning from each other.

Many respondents also expressed regret that the ‘futility of blame’ message of the Berwick review was offset by the continued culture of defensiveness in the NHS. As illustrated in Figure 9, the number of people working in the NHS in England who felt their organisation blames or punishes the people involved in incidents rose from 10% to 13% between 2010 and 2014. Such trends illustrate the potential impact, direct or indirect, of national policy on members of NHS staff, and the extent to which this can hinder progress in the areas where a growing consensus is emerging about the future frontiers for patient safety.

Thinking differently about patient safety

It is difficult to argue against suggestions that health care can be made safer. But to begin to bring about change, all those involved in providing health care need to start thinking differently about how safety improvement is supported across the NHS. National bodies and policymakers can support this by encouraging action in the following three areas:

• Developing a culture and system of learning.
• Improving safety across multiple care settings.
• Managing safety proactively.

Developing a culture and system of learning

The fundamental principles and ultimate goal of improving patient safety is to create a system where there is continual learning from past events to mitigate future risks. While many of the most far-reaching national developments have focused on building systems and cultures of learning, many of them have fallen short. The National Reporting and Learning System (NRLS) is one such example, where the original vision to identify problems rapidly in one part of the NHS and routinely develop and share solutions across the entire system has not been fully realised.

One reason this has happened is because people’s understanding of ‘learning’ is varied and vague. Learning is an active process that depends on collaboration and engagement between patients, professionals and policymakers to address practical problems. To have a material impact on patient safety, systems must be designed to provide people with the space and support to work constructively together on shared problems. Two emerging examples point the way.

• First, the government has committed to establishing an independent patient safety investigation function for the English NHS. The aim is to investigate rapidly, independently and routinely the most serious patient safety issues and make targeted recommendations for improvement across the entire health care system. Done effectively, this can ensure those working in health care actively examine and reflect on their practices, explore problems that span the health care system, and collectively develop and implement solutions.
• The second example is Q – an initiative, led by the Health Foundation and supported and co-funded by NHS England, connecting people skilled in improvement across the UK. Q will make it easier for people with expertise in improvement to share ideas, enhance their skills and make changes that bring tangible improvements in health and care. Q is bringing together a diverse range of people to form a community working to improve health and care. The aim of the initiative is to connect a critical mass of people in order to radically expand and accelerate improvements to the quality of care.

Improving safety across multiple care settings

Efforts to improve patient safety have historically focused on the hospital sector. This is because hospitals meet the needs of people with serious and immediate health concerns, where there is a greater risk of harm occurring. But the delivery of health care will increasingly shift out of hospital settings, and patient safety must follow. If care is going to be more integrated – where pathways of care will span multiple settings, where people will be increasingly managing their own conditions, or be cared for in their own homes rather than in controlled hospital environments – then those aiming to improve safety needs to respond.

A number of the Health Foundation’s improvement programmes have begun to test ideas to address the challenges presented by this shift. For instance, in East Kent, the acute trust has been working in partnership with the care home sector to implement a community geriatric team to tackle the problem of unplanned and avoidable readmissions. In Northumbria, structured medicines reviews are now done in partnership with care home residents to reduce unnecessary and potentially harmful medications. And in Airedale, a direct line has been established to link people in their own home or in residential homes with nurses and consultants outside of normal hours.

These types of approaches, which break down traditional organisational boundaries and see safety from the perspective of the patient, offer an exciting way forward for the recipients and providers of care alike. They also offer an insight into how safety can be managed more proactively, rather than simply waiting for something to go wrong before doing anything about it.

Managing safety proactively

Other ‘safety-critical industries’ have had their fair share of high-profile failures with tragic loss of life on a large scale – be it the Chernobyl nuclear meltdown in 1986 or the Tenerife airplane collision in 1977. As a consequence, these industries have embraced new ways of thinking more proactively about detecting hazards and managing risks in an effort to prevent any recurrence. For instance, tools such as risk registers are common in other industries, where they tend to be used in forward-looking ways to help diagnose problems in processes and identify prospective hazards. In health care, however, risk registers tend to be backward-looking, bureaucratic data-collection exercises. Though they often generate huge amounts of data, they are rarely used in a way that provides an accurate indicator of the next problem to arise or the underlying causes of harm.

Shifting away from delivering improvement through reducing incidences of harm to the proactive identification and management of hazards offers huge opportunities. It can help to diagnose more accurately known problems and surface previously unknown problems. While it is not possible to foresee and mitigate every possible risk, an organisation that is used to identifying, analysing, controlling and monitoring threats to patient safety routinely will be more resilient in the face of unexpected events. However, for such an approach to become commonplace across the NHS, there must be a system for safety improvement that encourages rather than inhibits this behaviour.

Our vision for an effective safety system

It is clear that work to improve practice at the front line and to develop organisation-wide approaches to safety will only yield limited further benefits if the issues identified in this report are not also recognised at the system level. We therefore set out a vision for an effective system for safety improvement, based on the four core themes used in the safety checklist presented in Part II: measurement and monitoring, improvement and learning, engagement and culture, and strategy and accountability.

We recommend that national bodies with a remit for patient safety, from across the UK, assess the extent to which their objectives, structures, policies and initiatives support the vision set out below. We ask them to reflect on any gaps or conflicts and take coordinated action to address them.

The progress made in improving patient safety over the past 15 years shows that the NHS has the will, skill and determination to make this vision a reality. Further improvements in safety will not be easy, and have to be achieved in the context of tightening financial constraints and increasing demands on the time and energy of people working in the NHS. But the many practical experiences and achievements of teams from across the NHS can act as inspiration to others. And important lessons from the past can help senior leaders and policymakers create an environment in which safety improvements can flourish in the future.

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