A realist analysis of hospital patient safety in Wales: applied learning for alternative contexts from a multisite case study

The extent and burden of the problem

Despite growing awareness of the challenges posed by patient safety,44–46 and concerted improvements efforts within some health-care systems,47,48 considerable hospital patient safety problems persist. Global estimates of the burden of harm vary. However, they are normally reported to be around 10% of all inpatient admissions with a range of 3.8–16.6%,49 though such results are influenced by the means of measurement employed. 50–53 In the UK, it is estimated that 1 in 10 NHS hospital patients is harmed during his or her care, and 1 in 300 dies as a result of adverse events such as acquired infection. 54,55 Along with these human costs, safety incidents are a drain on NHS resources, costing an estimated £3.5B per year in additional bed-days and negligence claims. 56

Avoidable harm takes various forms. Errors occurring during drug prescribing, supply and administration represent a significant and persistent burden. 57–62 So, too, do those that arise as a consequence of surgery. 63,64 A more hidden cause is, quite simply, incorrect diagnosis. 65–69 In addition, there is variation in the delivery of medical and nursing care. 70,71 Failure in the safety of care is a particular issue for high-risk patient groups,72,73 but all patients may be at risk of harm, for instance, from communication deficits at handover;74–77 from low staffing,78 especially at weekends; or because the delivery of care coincides with the influx of a new cohort of junior doctors in training. 79,80

Foundations of the problem

Rising concerns about patient safety have led, in recent years, to a number of public enquiries into highly publicised failures of the health-care system, such as patient safety failings at the Mid Staffordshire NHS Foundation Trust,81 events at the Bristol Royal Infirmary82 and the Royal Liverpool Children’s Hospital,83 and the actions of Dr Harold Shipman. 84 The major reports published following these enquiries have helped to identify reasons for the failures85 and have sought ways of improving the safety of patients. 86 Taken as a whole, the findings of successive UK inquiries have emphasised five issues that can be seen as foundations of the problem of patient safety: (1) deficits in cultures of care, (2) leadership inadequacies, (3) ineffective team working, (4) problematic regulatory oversight and governance systems and (5) limited patient and public engagement. We summarise these issues, and the recommendations made to address and eliminate them, in Table 1, as a way of introducing what was known (by us), prior to our study, about the context of patient safety.

The patient safety agenda

In 2013, the Francis Inquiry81 was accompanied by two major reports into hospital patient safety. The first was a review into the quality of care and treatment provided by 14 hospital trusts in England, led by Sir Bruce Keogh, National Medical Director for the NHS in England. 157 While this review acknowledged (as other commentators did158–160) the difficulties in adopting mortality measures as an indicator of hospital performance, it also set out core features of high-quality care for patients. The second, a report by the National Advisory Group on the Safety of Patients in England, led by Don Berwick, President Emeritus of the Institute for Healthcare Improvement (IHI),161 also endorsed these goals. Each addresses the foundations of the social problem of patient safety that are outlined in Table 1.

The improvement agenda proposed by these two recent reports is exacting. It demands changes in policies, the education of health-care professionals and wider NHS workforce and further research into the quality and safety of health care. 5

1000 Lives⁺ national programme in NHS Wales

Patient safety interventions range from isolated interventions within a discrete health-care setting, such as the estimation of intraoperative blood loss174 or the validation of specific measures of harm,175 through to national programmes of the type we are investigating in this study. 176

In April 2008, the Welsh 1000 Lives⁺ campaign was launched by a collaborative involving the Welsh Assembly Government’s Clinical Governance Support and Development Unit, the Wales Centre for Health, the National Leadership and Innovation Agency for Healthcare, the National Public Health Service and the National Patient Safety Agency. It had two distinct goals: (1) to reduce by 1000 the number of deaths caused by suboptimal care and (2) to reduce by 50,000 the number of adverse incidents. All health-care organisations in NHS Wales volunteered to participate in the programme. In 2010, the campaign was superseded by the 1000 Lives⁺ national programme. This continued the ethos of high-quality person-centred care and offered a broader range of patient safety interventions, and aligned resources, for NHS Wales’ health boards to implement. This ambitious and complex intervention built on the momentum of its predecessor and now forms a core component of the Welsh Government’s delivery framework for the NHS in Wales. As illustrated in Figure 1, 1000 Lives⁺ comprises a complex array of 11 core programme improvement areas.

FIGURE 1.

1000 Lives⁺ national patient safety programme areas.

In this study, our attention is concentrated on three focal interventions: (1) ILQI, (2) RSC and (3) RHAI.

The 1000 Lives⁺ programme and its predecessor are adaptations of the IHI’s 100,000 Lives campaign. 162,177 Both are informed by the Model for Improvement (MI), developed by Langley et al. ,178 depicted in Figure 2. This model179,180 first directs attention to three questions: what are we trying to accomplish?; how will we know that a change is an improvement?; and what changes can we make that will result in improvement? It then prescribes the implementation of solutions through a Model for Improvement, Plan-Do-Study-Act (MI-PDSA) cycle.

FIGURE 2.

Model for improvement.

Centred on Deming’s system of profound knowledge,178 the MI-PDSA approach is an acknowledged cornerstone of the science of improvement,44,181 and is informed by a diverse array of theoretical perspectives.

The MI-PDSA cycle has been promoted by the IHI as the means to foster the transformation of patient safety. 172 The strength and success of this promotion is reflected in the way that the MI-PDSA approach has been applied across a range of contexts, and to a variety of issues. Many of these themes are of direct relevance to this study, including (i) the role of local champions in leading change;182–184 (ii) the education of health-care professionals in evidence-based practice change;185–188 (iii) the implementation of the World Health Organization Surgical Safety Checklist (WHOSSC);169,189–191 (iv) the development and implementation of anti-infective prescribing policies,192–194 including those for correct hand hygiene;195 and (v) the large-scale transformation of health-care services through a heightened emphasis on patient safety. 5,196

Design, implementation and evaluation

The 1000 Lives⁺ national programme incorporated a range of IHI-inspired patient safety interventions that have been utilised worldwide. 5 These include (i) the use of checklists; (ii) care bundles (checklists and associated directive guidelines) for high-risk drugs197 and invasive practices;192,198,199 (iii) multicomponent interventions, such as those advocated for the prevention and management of pressure ulcers, falls and hospital-acquired infections;200–203 and (iv) various other forms of intervention, including staff training,118,204–206 adverse event simulation,207,208 computer-assisted care management,62,209 national and/or local alert systems and trigger tools. 28,53,210,211

Context matters

Despite having a basic improvement approach in common, the differences in scale and scope of the patient safety programmes impact on both the complexity of their implementation and the evaluation of their outcomes5,168,212–215 and the reported outcomes of these interventions are marked by considerable variation. However, although public inquiries and research evidence now concur that patient safety is, in part, a matter of context,168 there has been very limited systematic and independent analysis of the relationship between organisational factors which shape the local context of health care and the outcomes of patient safety interventions. 124,216–223

Prior to this study, relationships between the recently advocated ‘four high-priority’ features of organisational context:5,223 (1) external factors such as regulatory requirements; (2) organisational structural characteristics; (3) leadership, team work and patient safety culture; and (4) management priorities – and the outcomes of safety programmes were both undertheorised and poorly understood in empirical terms. 224 As a result, the context of patient safety remained amorphous225 and ill defined. 226 In contrast, this study is designed to address the conceptual and empirical knowledge gaps involving the context of patient safety.

Aim and objectives

This study employs insights from institutional theory227 within a realist analysis framework228–235 to examine the impact of context on the implementation of the 1000 Lives⁺ national programme across the Welsh NHS. We present and explain our conceptual framework in Chapter 2.

Our approach arises from an appreciation that the influence of organisational features on hospital patient safety programmes cannot be readily understood from traditional evaluation methods. 236,274 Building on findings from previous studies of the design237 implementation,21,220,238,239 and outcomes146,240 of patient safety improvement programmes, we examine the implementation of three focal interventions in a multisite comparative-intensive case study of hospitals in NHS Wales. We seek to reveal the complex interplay of context and concerns,234,235 captured through the organisational factors and competing institutional logics – belief systems – which guide acceptance of, or resistance to, the local adoption and adaptation of patient safety programmes. 3,240

This realist analysis of patient safety aims to ascertain which contextual factors matter, and how, why and for whom they matter, in the hope that processes and outcomes of future improvement programmes may be improved. Hence the unit of analysis in this study is the process of local implementation of the 1000 Lives⁺ programme, centred on the three focal interventions (rather than an evaluation of the 1000 Lives⁺ programme per se). The study has five main objectives:

1. to identify and analyse the organisational factors (e.g. structure, culture and managerial priorities) pertinent to the health outcomes of hospital patient safety interventions

2. to identify and analyse the contextual mechanisms (logics or belief systems) that interact with organisational factors to generate the health outcomes of hospital patient safety interventions

3. to develop and test hypotheses concerning relationships between organisational factors, mechanisms and the health outcomes of hospital patient safety interventions

4. to produce a theoretically grounded and evidence-based model of which organisational factors matter, how they matter and why they matter

5. to establish and disseminate lessons for a broad range of stakeholders concerned with patient safety policy and management.

The achievement of these objectives should allow us to suggest how a particular configuration of organisational factors may influence the mechanisms that lead to more or less successful health outcomes of the three focal safety interventions considered. It is hoped that these findings will inform policy-makers, managers and practitioners, locally, nationally and internationally; will empower stakeholders to develop improvement interventions that are more likely to work in their local contingent circumstances; and may serve as a diagnostic tool to be used as a precursor to the design of more differentiated and context-sensitive interventions in future.

Report structure

The remainder of this report is presented in eight further chapters. Recognising the complexity of the subject matter and the novelty of our conceptual framework, we have produced an innovative set of explanatory schematics to accompany each chapter, in addition to our use of standard data tables and figures. Below, we outline the structure of this report and the way in which we combine text, explanatory schematics and other forms of data presentation to ensure the clarity of our reporting.

Chapter 2 presents the conceptual framework developed in this study – realist analysis – and defines our elaboration of established approaches to realist inquiry, centred on Archerian critical realism and augmented by sociological institutionalism and neo-institutional theory (see Figures 3–6).

Chapter 3 presents the research design – comparative case study – and multimethod approach to data collection and analysis (including our alignment to realist analysis) (see Figure 7 and Tables 2–5).

Chapters 4 and 5 present our analysis of the implementation and institutionalisation of the 1000 Lives⁺ programme in NHS Wales. Together, they form the foundation for our realist analysis of the three focal interventions selected from the programme. Chapter 4 presents our analysis of the bureaucratisation of 1000 Lives⁺ programme across NHS Wales, defining our preliminary understanding of the local implementation of the 1000 Lives⁺ programme (see Figures 8–11 and Tables 6–9). Chapter 5 explores interpersonal and individual engagement with 1000 Lives⁺ to offer an account of the normalisation of the programme at the level of the functional team within each health board (see Figures 12–15 and Table 10).

Chapters 6–8 present our realist analysis of the three focal interventions – ILQI, RSC and RHAI – and our understanding of the complex and dynamic relationships between organisational factors, generative mechanisms and the outcomes of hospital patient safety interventions: Chapter 6, Improving Leadership for Quality Improvement (see Figures 16 and 17, and Tables 11–21); Chapter 7, Reducing Surgical Complications (see Figures 18–20 and Tables 22–27); and Chapter 8, Reducing Health-care Associated Infection (see Figures 21 and 22, and Tables 28–33).

Chapter 9 presents the discussion and conclusion of our study, wherein we debate which contextual factors appear to impact on the implementation of patient safety improvement programmes, promoting or retarding their local success. In addition, we discuss the generalisability of our findings, the limitations of our study and potential for future work in this important area.

Intended audience

Throughout this report we have been concerned to ensure that our findings are accessible to the public, professionals, researchers and policy-makers wishing to (a) better understand existing improvement programmes and (b) design more effective ones in the future. We hope that our innovative use of neat description and summary graphics will assist in this objective, and the summaries presented in Chapters 1 and 9 are written for this extended audience in particular. In addition, we hope that much of the detailed narrative in the report will be of relevance to social scientists and others with an academic interest in the realist analysis of complex organisational phenomena.

Realist inquiry

In realist inquiry, testable propositions of how an intervention is perceived to work are depicted through context–mechanism–outcome configurations (hereafter, CMO configurations). 228 In essence, a CMO configuration is a hypothesis that the programme outcome (O) emerges because of the action of some underlying mechanisms (M), which come into operation only in particular contexts (C). 256 Each CMO configuration, therefore, explicates and progressively refines the scope of the original programme theory. 258–260 In this manner, a virtuous circle is completed, fostering deeper understanding of the opportunities and challenges presented by an intervention, to inform future policy and practice.

Realist inquiry has gained increasing acceptance in health-care research, in part owing to its suitability for examining the implementation of complex interventions in heterogeneous, multiprofessional social systems. 261–266 However, a number of challenges have emerged concerning the operationalisation of each component of the CMO configuration. These challenges are discussed in the following four sections.

Sociological institutionalism

Within organisation studies, there has been a ‘growing disenchantment’ with analytical perspectives that emphasise the influence of managerial rationality within organisational life. 326 Rejecting the tenets of strategic management and classical economic theory, sociological institutionalists examine the significance of institutions, the ‘regulative, normative and cognitive [see Glossary] structures that provide stability and meaning to social behaviour’. 327

Some of the main contributions to understanding institutional change and inertia in health care have emerged from analyses conducted at the level of organisational fields, defined as communities of organisations that ‘partake of a common meaning system and whose participants interact more frequently and fatefully with one another than with actors outside of the field’. 328 In a seminal example, DiMaggio and Powell329 suggest that within organisational fields, three forces – mimetic (copying those perceived to be successful), coercive (e.g. regulation) and normative (e.g. stemming from professional norms) – combine to produce powerful templates of what constitutes legitimate organisational structure and action, and we use these terms in our analyses of the data from our study.

In common with critical realism, sociological institutionalism depicts a world of virtual depth,330 stratified and organised through different levels of institutional structures, along with their logics, or commonly held sets of beliefs and values. There are higher, or macro-level, structures; these include societal systems such as the bureaucratic state, capitalist markets, democracy and religion. Then come meso-level structures characterised as organisation sectors or fields; these are composed of those organisations that are involved in a particular issue or policy community. The concept incorporates field-level structures, participating organisations and the people working within and between these organisations. For instance, the field of health-care organisations comprises distinctive actors, diverse institutional logics and distinct governance structures. Finally, there is the micro-level of the individual organisation, together with further intraorganisational levels or groups.

Typically, the multiplicity of logics in a given domain is represented as some combinations of (i) higher-order societal logics,331 (ii) field-level logics332 and (iii) institutional or ‘cultural’ logics. 333 At the societal level, heterogeneous higher-order logics sculpt the social world, conveying the core organising principles of different sectors. 331 Institutional logics orchestrate lower-level institutional strata and ensuing practices. They shape organisational interests, individual preferences, define actors’ expectations about each other’s behaviour and organise their enduring relations with each other. 330,334

Previous studies of UK health-care fields have concentrated on the role of, and dynamics among, three logics: professionalism, bureaucracy and market. Professional logic was dominant for much of the twentieth century and gave workers with specialised knowledge (e.g. doctors) cultural and material privileges, including the power to organise and control their own work and that of others. 335,336 The primary justification for these arrangements was that service delivery is optimised when it is under the control of experts acting with the altruism they are assumed to develop during prolonged training and socialisation. During the latter part of the twentieth century, successive governments promoted combinations of two alternative logics in health care: (1) bureaucratic logic, which holds that service delivery is improved under the administrative control of work using techniques of performance management, and (2) market logic, which holds that improved service delivery arises from conditions of competition among providers and choice among clients.

In our framework, multiple layers of logics constitute and provide the inherent structure to context. However, organisational actors (or agents) may go along with or actively resist these social prescriptions,337 thus inhibiting or supporting change. The process of institutional change is, therefore, both enabled and constrained by (i) the array of institutions, which compose and condition the substructure of the health-care field, and (ii) agential theorisation, reflexivity and ensuing modes of institutional work. 338–340 Accordingly, even though institutions provide meaning to social life, such conditioning is non-deterministic. 229,341

Realist social theory

To further elaborate realist inquiry, we turn to Margaret Archer’s seminal work on critical realism. 229–235 As in Herepath’s study,342 our approach employs Archer’s conceptual approach to structure,229 culture230 and agency,231 together with her later work on reflexivity. 232–235 Our reasons for incorporating Archer’s realist social theory are threefold.

First, Archer’s ontological stance holds structure (context) and agency (mechanism) as separate entities. Consequently, Archer offers help to researchers who struggle over this distinction when analysing the complex interplay of context and mechanism during the development of CMO configurations.

Second, an Archerian approach resonates with sociological institutionalism. 343,344 Hence by harnessing institutional theory within an Archerian approach, institutions are given their due recognition and temporal role as both symbolic constructions and a set of material practices which guide actors’ behaviours. 345 This helps to reveal the multiple logics which shape adherence to, or disregard for, the components of an improvement programme and its underlying ethos.

Third, an Archerian approach offers a robust methodological framework composed of three phases,229 which parallel the context, mechanism and outcome components of a CMO configuration. Therefore, methodologically, the researcher is guided by an aligned approach that helps to distinguish the boundaries between context and mechanism and to reveal possible causal links between them.

Intervention: a distinct analytical category

Our first elaboration to realist inquiry is to include intervention as a separate analytical category in our realist analysis model. This stems from our recognition that although realist studies have adopted similar Pawsonian conceptions of intervention, the absence of intervention as an analytical component has encouraged its underspecification and conflation within context. 286

We therefore consider that there is an imperative within realist inquiry to (i) explicitly define the intervention ‘I’ and (ii) add this to Pawson’s original CMO formula to produce intervention–context–mechanism–agency–outcome (I-CMAO) configurations. This allows us to understand precisely ‘what’ is working in a situated context, for whom, how and in what broader circumstances. This refinement is depicted in Figures 3 and 4, and this method of representation forms the basis of all the translational schematics for the realist analysis presented in Chapters 6–8.

FIGURE 3.

Basic I-CMAO schematic.

FIGURE 4.

Translation from a CMO configuration to an I-CMAO configuration.

Context: structural conditioning

As noted earlier, both realist inquiry and sociological institutionalism not only stress the importance of context228 but also warn that to enable meaningful explanatory analysis, context cannot be reduced to the spatial, geographical or institutional location into which a social programme is introduced and that a more nuanced understanding of the multiple layers that compose a given context must be established. 236,244,257

Guided by the approach to realist inquiry adopted by Pawson,228 we address the need to develop a more subtle analysis of context by specifying four main levels of contextual hierarchy (infrastructural system, institutional setting, interpersonal relations and individual) with all but the individual level divided into substrata (see Figure 5).

At the highest hierarchical level, we see the infrastructural system of the Welsh health-care state as comprising three strata: (1) the higher-order societal logics which mould this contextual arena; (2) the Welsh Government, as a devolved substate nation, and (3) the public sector partner agencies with regulatory oversight of health-care quality and patient safety, which operate in close liaison with, but distinct from, the Welsh Government and NHS Wales. The second highest hierarchical level of context, the institutional setting, is conceptualised through two strata: (4) NHS Wales, as a corporate whole, and (5) its seven constituent health boards as distinct multisite organisations. The third level, interpersonal relationships, which constitute the relational structure within which actors are embedded, is captured across two further strata: (6) a hospital site-based ward or multisite department and (7) the functional team (the group of people who carry out the tasks involved in running a ward or department). Our final stratum (8) describes the capacities of the individual actors.

However, a stratified model of context provides only the basic architecture of our argument, as it lacks the means to consider context as ‘situated’, meaning dynamic, conditioned, relational and temporally fluid. In essence, we see the dynamism of context as contoured by emergent structural, cultural and agential powers across time. Our recourse to Archerian critical realism, together with the work of Herepath,342 therefore offers a more complex yet nuanced means to develop I-CMAO configurations.

An underlying premise of realist theory and research is that context affects or mediates ensuing agential actions346 and hence the structural constraints and enablements of context are mediated to the agent as first-order emergents. First-order emergents encompass agents’ placement within their broader social context and roles, their vested interests, the opportunity costs associated with different courses of action and, thus, their perceived interpretive freedom. Such first-order emergents impact differently on each agent, enabling or frustrating the attainment of their desired goals depending on their social bargaining power, both as individuals and as members of groups. Consequently, our analysis of how context impinges on agents is stratified across three levels: social position, how their roles relate to others and the cultural logics of the institutional domain within which they are situated. In this way we expose the contextual constraints and enablements imposed on the agent.

The second stage by which the constraints and enablements of context are mediated addresses how agents, conditioned by their contexts, think about and influence the formulation of their desired projects, both individually and collectively. 232 These influences give rise to potential second-order emergents (i.e ‘the results of the results’ of the first-order emergent properties346), which in their turn affect the ways in which an intervention is implemented.

Accordingly, in our realist analysis, we separate context from its mediation (or the effects of the context on the intervention). As depicted in Figure 5, we first specify the explicit stratum concerned, so that hierarchical and heterarchical influences may be more readily appreciated within a situated context. Second, we identify dominant structural and cultural emergent properties within that context to define the structural conditioning in play. Third, we apportion its mediation to mechanism, as expanded in Mechanism: sociocultural interaction.

FIGURE 5.

Contextual strata: structural conditioning, hierarchical and heterarchical metamechanisms.

Mechanism: sociocultural interaction

In her later work, Archer has refined her conceptualisation of the mediation of contextual influences, which, she contends, is undertaken via two mechanisms: habituation, guiding routine action, and reflexivity, guiding those actions which demand a more creative response. 338 Critically, Archer asserts that such reflexive theorisation occurs through three stages: (1) discernment, the preliminary review stage of an issue of concern, where reflective retrospective and prospective thought informs practical action; (2) deliberation, involving the ranking of such concerns against others; and (3) dedication, entailing their prioritisation and alignment to foster a fallible yet correctable commitment to a chosen path. Reflexive theorisation thus represents the explicit interplay of social context and personal concerns that lies at the heart of Pawson’s notion of mechanism.

Following this approach, in our realist analysis we allocate contextual mediation to mechanism, and to this we add reflexive theorisation. Furthermore, as depicted in Figure 6, we distinguish the conceptual elements of mechanism from its ensuing outcome, illuminating the fundamental role of beliefs and values – institutional logics – on the propensity to act, and revealing the contested nature of institutional change and practice evolution.

FIGURE 6.

Mechanism: mediation via reflexive theorisation vs. habituation.

In this study of the 1000 Lives⁺ programme, we examine the demarcation between context and mechanism, focusing on mediation, reflexive theorisation, ensuing agency via negotiation and the mode of institutional work enacted during two fundamental institutional processes: bureaucratisation and normalisation. These, we contend, operate as sociocultural and organisational meta mechanisms, the underpinning carriers347 of the processes of health-care change desired by 1000 Lives⁺. In essence, it is through successful embedding within these fundamental meta-mechanisms that the patient safety programme becomes institutionalised.

Agency and ensuing outcomes: structural and cultural elaboration or reproduction

In our realist analysis framework, outcome is not perceived as a simple, single aspect of change such as a defined health outcome. Instead, it is recognised that the multifaceted nature of an intervention, particularly when implemented within different organisations, each shaped by their own contextual constraints and enablements, gives rise to discordant mechanisms which trigger different patterns of social transformation. 243,269 Moreover, such outcome patterns are contingent on all the tiny process and positioning issues that occur on the way to the goal. 244

Our framework is, therefore, concerned with the explication of these unfolding actions over time. Specifically, we seek to examine the means through which the health-care practice change advocated by the 1000 Lives⁺ programme, and the three focal interventions we consider in depth, are negotiated by the functional teams positioned within the contextual strata depicted in Figure 5. We thus seek to illuminate how health-care practice evolves (or not) over time, by considering the third-order emergents impacting within the contextual arena.

Third-order emergents arise from the effects of first- and second-order influences on the outcomes of the intervention. 229 This concept, therefore, captures structural and ideational differentiation, together with the regrouping inherent to the power play of a diverse array of agents.

Anonymisation

All seven health boards in NHS Wales participated in the study. Summary data describing each organisation are presented in Appendix 1. To ensure anonymity from this stage of the report onwards, participant health boards are identified via a randomly assigned code letter from A to G. Numeric subscripts are then used to identify a constituent major hospital (X₁), a constituent district general hospital (X₂) or a constituent small local community hospital (X₃).

Ontological and epistemological alignment to realist analysis

The basic premise, or ontology, of critical realist informed research is that the world may be viewed as stratified into three domains in which are apparent structures, mechanisms, powers and relations; events and actions; and experiences and perceptions. 362,363 Research in this tradition focuses on the identification and explanation of the underlying generative mechanisms that shape structure, agency and the social relations that are reproduced and/or transformed. 252

The nature of the approach taken by realist research does impose limitations on what may be revealed through a comparative case study research design. However, it is a viable means for discerning structures and mechanisms, conveyed through our understanding of the social world and, thus, subject to revision as our collective knowledge is refined. 363,365 Nevertheless, one cannot connect powers or causal mechanisms to events and perceptions easily or securely by simple inspection. 366 This is because, once set in motion, they continue to have an influence even if other countervailing powers and mechanisms prevent this influence manifesting itself. The act of drawing conclusions from a comparative case study is, therefore, a complex matter. It is informed by epistemology (what we think is known), the nature of the comparisons made between cases and the mode of inference employed.

Comparative case study research designs using a critical realist approach must, therefore, seek to define constraining and enabling social structures, encompassing organisations, groups and individuals, together with the rules, practices, technological artefacts, discourse and culture which they manifest. 365 In addition, social actors’ interpretations of such structures, and their beliefs, values and theories, require detailed consideration. The comparisons made between cases draw on abductive and retroductive modes of inference as opposed to inductive and deductive. 363,364 Abduction involves the production of an elementary account of a basic process or mechanism. 363 Retroduction builds on this analytical stage to reconstruct the basic conditions for such phenomena to be what they are, so fostering knowledge of the conditions, structures and mechanisms in play. 362,363 Abstraction forms the basis of both abduction and retroduction. As empirically demonstrated by Herepath,342 abstraction draws out the various components within the situated context so that the researcher may gain new insight into the way they combine and interact.

Case site selection and sampling strategy

Case site selection was based on a two-stage sampling strategy. In phase 1, four clear and readily operable criteria – corporate parent, complexity, function and geographical coverage – were employed to define the purposive sample of case-site hospitals within each health board (see Appendix 1), and three within-case comparators were selected from each health board: (1) a major hospital, (2) a district general hospital and (3) a small community hospital. This approach ensured theoretical variation in I-CMAO configurations by optimising the scope for description, interpretation and explanatory analysis, while reducing chance associations. 367–369 In contrast, in phase 2, the focus of the study was narrowed to four local health boards, and centred on deeper examination of the most promising I-CMAO configurations for the three focal interventions examined from the 1000 Lives⁺ programme.

Data collection, coding and analysis

In adopting an overarching approach that combined realist inquiry with regard to the explication of I-CMAO configurations, this study sought to examine the contextual conditioning which predated the launch of the 1000 Lives⁺ programme, together with the mechanisms which emerged from the social interaction of different groups of health-care workers engaged in its implementation, and the subsequent outcome on the embedded practices of day-to-day health-care practice. As illustrated by the schedule of data methods and sources illustrated in Figure 7, and expanded in the following four sections, a wide range of data collection methods were used. 256

FIGURE 7.

Schedule of data methods and sources.

Access to patient stories and organisational culture survey data

During the design and development of the grant application for this study, the research team was assured of access to an archive of patient stories and organisational culture survey data held by the 1000 Lives⁺ programme team. Following the commencement of the study, working in close liaison with the 1000 Lives⁺ programme team, three critical issues emerged on review of these data. First, and most importantly, these data lacked ethical approval and informed patient consent for use for research purposes. Second, the patient stories data had been collected via inconsistent means and lacked the requisite information to verify or contact data sources. Given such issues, these data were, therefore, used in a restricted manner to inform the phase 1 interview guide. Third, with respect to the organisational culture survey data, that archive reflected the organisational boundaries prior to the reconfiguration of NHS Wales. The research teams therefore considered that such historical data provide limited insight into NHS Wales’ evolving cultural composition post reconfiguration. These data were, therefore, used only to inform the research team’s understanding of organisational context, and the organisational legacy effect that it imparts, within each reconfigured health board.

Supplementary quantitative data quality

During phases 1 and 2 of the study, data from interviews and documentary analysis indicated that, with respect to the focal interventions ILQI and RSC, the desired supplementary quantitative data were of inconsistent quality. This issue did not impact RHAI because mandatory surveillance data were available via the Welsh Healthcare Associated Infection Programme (WHAIP) led by Public Health Wales. The research team discussed this issue at length with the study’s advisory board and commissioners, who advocated the continued investigation of the three focal interventions adjusted to reflect the broader organisational outcomes of the 1000 Lives⁺ programme and focal interventions.

Bureaucratic state logic

As illustrated in Figure 8, the logic of the bureaucratic state is expressed through an array of structural features that inculcate a pervasive performance measurement and management ethos across the Welsh health-care field. 385,386 Much of this was introduced under the UK New Labour government, such as new systems for clinical governance, a statutory duty of quality and evidence-based national service frameworks. That government also laid the foundations for an array of arm’s-length bodies that retain the scope for direct intervention in the NHS in England and Wales. 387 Some have even seen this as a precursor to the legitimisation of the role of the state as the guarantor of social provision, rather than as the sole provider,388 a stance which resonated with the policy approach of the 2010 UK Conservative–Liberal Democrat coalition government. However, while the logic of the bureaucratic state imposes a sense of control, the efficient use of resources resides largely within the control of discrete professionals. 389 This logic is, therefore, tempered by the wielding of professional power at the individual and group level,390 as illustrated in Figures 8 and 9.

FIGURE 8.

Institutional logics in the Welsh health-care institutional field.

FIGURE 9.

Institutional logics in the Welsh health-care institutional field: dominant and subordinate logics in a complementary, co-existent or countervailing alignment.

In Wales, the bureaucratic state logic of the Welsh Government orchestrates the top-down performance measurement and management of the 1000 Lives campaign and the successor 1000 Lives⁺ programme. For example, under the mantle of 1000 Lives⁺, NHS Wales’ constituent organisations are tasked to (i) set appropriate local targets for the reduction of harm and hospital mortality, initially by employing the Trigger Tool for hospitals; (ii) demonstrate participation in 1000 Lives⁺ through the appointment of executive leads; and (iii) collect robust data so that local variation in service provision may be identified, analysed and understood, resulting in the development of intelligent targets for service improvement and patient safety. 391 Strategic oversight of such actions rests with the National Quality and Safety Forum instituted in 2012.

Capitalist market logic replaced by collaboration

The UK New Labour government followed the Conservative adherence to new public management, aiming to increase the efficiency and quality of service provision through the logic of the capitalist market. For the UK health-care field this approach could be seen in the encouragement of aspects of competition, contestability and practice-based commissioning, and the same stance lingered on in the 2010 UK Conservative–Liberal Democrat coalition government’s health-care policy. However, in the post-devolution Welsh health-care field, this logic has been opposed and replaced by collaboration. 392 Importantly, the Government of Wales Act (2006) requires the Welsh Government to work in formal partnership with the voluntary sector, local government and businesses. This constitutes a set of operational requirements not paralleled elsewhere in the UK. 393

The NHS reforms in Wales have, therefore, sought to inculcate a new set of behaviours – replacing competition with collaboration, joint working and whole-systems thinking – to foster a greater emphasis on quality and patient safety outcomes. This collaborative logic is interwoven throughout the 1000 Lives⁺ programme, as evidenced by its integral mini-collaboratives, and national learning and networking events, which foster co-operation, knowledge sharing and peer challenge. Furthermore, strategic oversight of health-care standards and patient safety performance in Wales requires collaboration across the National Quality and Safety Forum, Welsh Government, HIW, PSOW, CHCs and health-care providers, including those in the independent sector.

Professional logic

Despite Wales’ adoption of a collaborative approach, the ideological approach to public management reform adopted by the UK government still impacts on Wales through its reserved powers. Thus, at the field level, professional logic – be that corporate management or the array of hierarchically positioned health-care professionals394 – remains constrained. Indeed, what can be seen is an explicit focus on workforce development (and, thus, organisational development) through a managerialist variant of transformational leadership,395 role redesign and adherence to prescriptive standards that seek to build staff capacity and capability while reducing service variation. 396 This logic is inescapably interwoven with performance management. As asserted in the current quality delivery plan for NHS Wales,391 the operationalisation of the 1000 Lives⁺ programme is central to the building of staff capacity and capability across NHS Wales:

1000 Lives⁺ will continue to be the core NHS improvement programme, ensuring a common and consistent language and approach to improvement.

Health Boards and Trusts will agree a plan to train 25 per cent of their directly employed and contractor workforce in quality improvement methodology (at basic, expert or leadership level) by the end of March 2014, supported by 1000 Lives⁺.

Achieving Excellence: The Quality Delivery Plan for the NHS in Wales 2012–2016 (2012)391

Democratic logic

Although the logic of democracy, expressed in policy through the desire for heightened user participation, engagement and control over public services, appeared in the Conservative Party’s general election manifesto of 1979, it reached new heights during the first term of the New Labour government. Beginning with the promotion of openness and public involvement in the NHS,397 it progressed to the heightened legitimacy and authority of lay voices398 and the later adoption of a Scandinavian model of explicit patient choice which evolved into individualisation and coproduction. However, it is uncertain if this approach can or will be fully realised, as its implementation is dependent on many factors, not least that appropriate program design is essential if engagement with the citizen-consumer is to be effective. 399,400

In the Welsh health-care field, given the overt rejection of market logic, the policy levers for provider pluralism and ensuing choice were not available. Wales has, therefore, embraced a citizen-centred model,392 adhering to notions of collectivism and standardisation as in the traditional socialist values of equality, social justice and social inclusion in policy. 401 The 1000 Lives⁺ programme explicitly seeks to actively engage patients in the coproduction of their health care. Indeed, as expanded in Chapter 6, patient stories represent an important means of gaining feedback. In addition, an aligned programme, Putting Things Right, launched in April 2011 (www.wales.nhs.uk/sites3/home.cfm?orgid=932), facilitates the communication of what are collectively termed ‘concerns’ (complaints, claims and incidents reports) into the standards of health-care delivery and patient safety in NHS Wales. This operates in parallel with NHS Wales’ governance framework.

Patient safety governance processes in NHS Wales

The 1000 Lives⁺ programme has now become integrated within organisational and professional patient safety governance processes operating across the Welsh health-care field and this complex patient safety intervention was perceived to symbolise and be part of the language of working together (transcription 4:11, below).

I think 1000 Lives⁺, certainly, because by its very nature it’s a collaborative approach, it gives you a way of getting people in a room. Also, because it’s badged 1000 Lives⁺ it probably doesn’t feel as threatening to some board-level stakeholders – it’s a convenient badge that’s become a metaphor for working together – the terminology, it’s become part of the patient safety language of NHS Wales.

Policy lead, Welsh Government (146); transcription 4:11

External oversight of health-care quality and patient safety

In Wales, HIW, CHCs and the PSOW provide external oversight of health-care quality and patient safety. Such audit processes were seen as helping to validate the delivery of appropriate health-care standards, promoting change through identifying service failings (transcription 4:31, below).

Healthcare Inspectorate Wales did a spot audit here, last October I think it was, and on the particular morning they came in – I wasn’t here, I wasn’t on duty, and the sister wasn’t here and there were a couple of staff off – it was absolutely bedlam! There were two patients dying, so two lots of family in and there were doctors everywhere, because it was after 9 o’clock and a load of medical students came to the ward. The linen trolley with the fresh linen for the day had been thrown in. People were doing breakfast; they were still doing breakfast! It looked like an absolute bombsite apparently. And in the audit they completely floored us . . . but, since then, I think it did us a favour because there were some things that we’d been fighting to get done because, as you know, this is an old ward. So there are things that we’ve managed to get changed on the back of this audit. So it’s done us little favours.

Ward manager, case site B₁ (060); transcription 4:31

Furthermore, audits provided an important external source of data, countering parochialism and strengthening democratic challenge across NHS Wales (transcription 4:32, below).

[Do you report back to the Welsh Government?] For Welsh Government – well, there’s a firewall between them and us [a CHC in Wales] – but we are an agent of government. However, having said that, we are a pain in their side – we say things they don’t want to hear – the political view is obviously very different. But it’s my duty to tell the truth to government, to tell them: ‘actually you’re not providing sufficient care, or your health boards with sufficient money to provide that care, and patients are struggling. Ultimately, you’re to blame guys – don’t blame the health boards – you’re to blame’. Basically, we’re seeing the NHS being removed by stealth. The government are going to be very cross with me, but I have a duty to speak on behalf of patients, so there you go!

[Does the politicisation of health care make it difficult for you to expose problems?] Yes, if it lands in the minister’s lap and the minister doesn’t like it! There’ll be a level of ‘ball bouncing’ between government civil servants and the CHCs simply because they don’t want that to land on the Minister’s desk. I can’t say I blame them. But it is my job to speak honestly on behalf of patients. Patients are David to the NHS’ Goliath and how on earth can they possibly fight that giant?

Chief Executive, CHC in Wales (073); transcription 4:32

The role of ‘critical friend’, working in creative tension with a partner health board, is central to the scrutiny of local health services and advocacy support to complainants (transcription 4:33). However, for some health boards, these vital relationships may be fraught (transcription 4:34). Moreover, in discussions with such external organisations, though awareness of the 1000 Lives⁺ programme was evident, monitoring of adherence to its practices was overshadowed by the use of competing performance measures. Health boards were also concerned with this issue (transcription 4:35, below).

The Healthcare Standard we’ve just got used to, well, for me, it’s now much more of a narrative – you tell your story – it’s like we’ve gone from a series of MOTs and driving tests and garage inspections to a sticker on the back of the car saying: ‘How’s my driving?’. It’s a bit like: ‘here’s the standards for health care, how do you think you are doing?’. Not one of them is a genuine standard, which really confuses staff; they’re basically a list of aspirational statements and we’re left essentially to our own devices about how we decide whether we meet them or not. My joke was that they could have saved a lot of time and money by just printing a lot of mouse-mats with the standards on because it’s an aide memoire – it’s basically a wish list. So that’s a different approach to quality improvement. We’re now encouraged to be more self-reflective and self-reliant but it is difficult because people always get things wrong and screw up and how do you legislate for that?

Executive Director, case site G₁ (011); transcription 4:35

Patient safety and competing contextual challenges

The 1000 Lives⁺ programme, and the predecessor 1000 Lives campaign, have been implemented during a major structural reconfiguration of NHS Wales. This has created a contextual challenge, specifically for the leadership and communication of the patient safety agenda (transcription 4:36, below) adding to the potential for distraction (transcriptions 4:37 and 4:38).

Post reconfiguration, I suppose, the size of the organisation brings its own challenges – it’s a huge challenge – how do you communicate things effectively when you’re that big? For 1000 Lives⁺ and other health board strategies, my biggest challenge is keeping in touch with what the organisation’s priorities are – what is [name] chief priority as chief executive, how is he driving that forward – if we’re going to make things change in line with his strategy, you’ve got to know what it is. If you don’t know what it is, how on earth are we going to do that? There’re so many tiers to go through now. I don’t want to harp back all the time but it’s a valid comparison because before I could talk directly to the chief executive because I’d see him in the corridor, and the medical director; those relationships were direct then, weren’t they? Before you had the key people in your organisation – that physical proximity, almost a direct route on a formal and informal basis – you would be kept up to speed when things were going on. But now, it’s lost.

Associate Director, case site B₂ (009); transcription 4:36

However, the greatest challenge arises, unsurprisingly, from unstinting financial pressures. All areas of NHS Wales are expected to do more with less and this confronts the 1000 Lives⁺ programme with a stark challenge (transcriptions 4:39 and 4:40, below).

If we are to keep up the momentum on 1000 Lives⁺ the area that we need to keep pushing is the business case for quality – to have the evidence from all of the 1000 Lives⁺ improvement programmes to show where the cost savings are – to build that bank of evidence for cost savings through quality improvement; that’s where we need to get to.

Policy lead, Welsh Government (065); transcription 4:40

Disconfirmation

The overarching goals of 1000 Lives⁺ signal the need for institutional change through an admission that patients are not being cared for as well as they should be: what Schein, building on Lewin’s theories of planned change, calls an act of disconfirmation350,351 (Figures 10 and 11 and Tables 6–9). Thus, the process of institutional change in the Welsh health-care field begins with the transmission of the IHI’s influential MI-PDSA approach via elite institutional carriers,403,404 such as ministers and government officials, who, by conveying their political advocacy for such change – ‘sticking their heads above the political parapet’, as one respondent put it – promote the concept, encouraging others to introduce its ethos and practices by processes of imitation (mimetic institutional isomorphism329) and/or official directive (coercive institutional isomorphism329). In this context, the logic of the bureaucratic state is dominant, rendering the logics of collaboration, profession and democracy into a complementary stance under the influence of ministerial authorisation. However, it should be noted that implementation may be undermined when actors find it difficult to meet the organisational goals by using the explicit policies and procedures, and proceed to modify them, a process known as ‘gaming’405 (see Figure 11, point 2, and Chapter 7, Realist analysis and comparative case study, Sociocultural interaction: agency and strategic negotiation).

FIGURE 10.

Bureaucratisation of 1000 Lives⁺: hierarchical metamechanism operating across the contextual strata of the infrastructural system and institutional setting.

FIGURE 11.

Bureaucratisation of 1000 Lives⁺: hierarchical metamechanism operating across the contextual strata of the interpersonal system within NHS Wales’ health boards.

At the level of the infrastructural system (see Table 6), the systemic legitimisation of the IHI’s MI-PDSA approach is signalled by the aligned names: 1000 Lives campaign and 1000 Lives⁺ national programme. Meanwhile, its formalisation is marked through the embedding of these patient safety interventions in Welsh health-care policy and governance systems.

As expanded in Table 7, both added democracy and authentication come from public sector partner agencies tasked with the external oversight of health-care quality and patient safety, with their inspection regimens encouraging adherence to 1000 Lives⁺ standards, beliefs and norms. Indeed, during the transition from the campaign to the national programme, the use of the 1000 Lives⁺ and associated MI-PDSA approach became embedded in the Welsh Government’s health-care policy, notably in its tier 1 targets and aligned performance metrics.

Deinstitutionalisation

At the level of NHS Wales and its constituent health boards, deinstitutionalisation, the second facet of the 1000 Lives⁺ local implementation, can be seen as the 1000 Lives⁺ programme’s mandate is legitimised via the Welsh Government’s Department of Health and Social Care (see Table 8). Formalisation then ensues as the programme is placed under the statutory oversight of local Quality and Safety Committees (see Figure 11). Through local acts of co-optation in each health board, leaders are assigned to each focal intervention. They are tasked to identify potential systemic failures, anticipate adverse events and reframe such issues as a social problem to be addressed through collaboration with health-care professionals across NHS Wales’ constituent health boards.

A wider range of health-care actors are gradually co-opted into 1000 Lives⁺ contributing to the multiprofessional and multisite co-ordination of patient safety. This generates internal challenge through which previously accepted standards of quality and safety – for example, the nature and frequency of adverse outcomes in theatre169,191,406 or for central venous catheter-related bloodstream infections407 – are viewed in a pejorative light. Practitioners, acting as institutional entrepreneurs,41 now collectively adopt a new normative standard leading to practice-based change181 and the rejection of old habits. This leads to institutional change and strengthens the collective will to create an organisational culture attuned to quality improvement. 408

Preinstitutionalisation

This constitutes the third facet of the local implementation of the 1000 Lives⁺ programme and is demonstrated at the interpersonal level, impacting functional teams, be they the executive board or ward-based clinicians. Importantly, as illustrated in Figure 9, in the context of the hospital department or ward-based functional team, professional logic (re)gains dominance. This creates the potential for discord between the different professional logics of health-care management, medicine, nursing and other allied professional groups, although Table 9 depicts this in a benign manner.

As illustrated in Figure 11, innovation can emerge from the evidence-based learning of the MI-PDSA approach. 172,409,410 The use of data to inform practice heightens the identification and awareness of systemic patient safety failings. 24,181,411 Furthermore, collaboration and communication across the multidisciplinary team is increased through testing of a rapid cycle of change. 172,180,187,412 This gives rise to knowledge mobilisation and greater understanding of variation in health-care service delivery. 187 However, the burden of data collection and demands of validation may retard meaningful engagement and give rise to the practice of gaming. 405 In addition, because performance measurement and monitoring systems are mandatory, the logic of the bureaucratic state again asserts dominance. This again creates the potential for discord among logics as illustrated by the decoupling expressed in the exemplar transcriptions.

Theorisation

This is central to the conceptual framework employed in our study. Greenwood et al. 227 contend that this manifests through the (i) specification of general organisational failings; (ii) justification of abstract possible solutions; and (iii) assertions of moral and pragmatic legitimacy. Hence, in refining perceptions of cause and effect, reflexive theorisation represents a key stage in individual and collective social actors’ adaptive response to institutional change. 413 It underpins the notion of mechanism, set out in Chapter 2, as the embodiment of an agent’s reasoning and their selective attention to the disparate resources offered through the 1000 Lives⁺ national programme.

As depicted in Figure 11, the implementation and bureaucratisation of 1000 Lives⁺ increases knowledge and understanding of the unfolding change, revealing common areas of failing and enabling refinements to be made. Such legitimisation helps to overcome reluctance and resistance to engage,127,414,415 and so aids its institutionalisation across NHS Wales. This end may be achieved through multidisciplinary team-based discussion,169,189,219 including focus groups with patients151,416 and health-care professionals,417 together with dedicated support for interorganisational learning. 261,418 Such processes aid emancipation of staff, giving them the authority, whatever their rank, to insist on correct safety procedures being followed. However, should this theorisation stage fail to change people’s values and attitudes appropriately, this may precipitate institutional decoupling,348,349 giving rise to the emergence of a legitimacy façade85 and the failure of the intervention.

Diffusion

Diffusion through wider adoption constitutes the fifth facet of the local implementation of the 1000 Lives⁺ programme. However, as noted by Berwick,419 continuous effort is required to maintain and spread the gain associated with such practice change. As illustrated in Table 7, at this interface the logic of democracy assumes dominance, fostering the external oversight of patient safety via public sector partner agencies’ inspection regimens to support this goal.

Reinstitutionalisation

This is the final facet of the 1000 Lives⁺ local implementation, reflecting widespread organisational acceptance of and adherence to the new programme. However, this, too, in acknowledging an ongoing commitment to the embedded MI-PDSA approach, must evolve with the shifting dynamic of the evidence-base3–5 and progressive rehabitualisation. 222

Coherence

As expressed in May’s normalisation process theory,352,353 coherence means that a practice – an ensemble of beliefs, behaviours and acts that manipulate or organise objects and others – is made possible by a set of ideas about its meaning, uses and utility and by socially defined and organised competencies. 353 In this regard, the 1000 Lives⁺ programme may be seen as a material object which facilitates the improvement of the patient safety in NHS Wales through the way in which the health-care team, both individually and collectively, think about and understand its meaning and carry out the practices involved.

As evident from patient safety studies undertaken in NHS Wales,210 the coherence and foundational competence of the 1000 Lives⁺ programme is clearly linked to the underpinning MI-PDSA approach. 178,219 This method of service improvement has been advocated in health care for many years420–423 and its widespread adoption in developed health-care systems promotes health-care actors’ awareness of the MI-PDSA approach as accepted practice,353 so aiding its embedding into day-to-day working. 186

Cognitive participation

The 1000 Lives⁺ programme is normalised through ongoing cognitive participation, defined by May and Finch353 as ‘the symbolic and real enrolments and engagements of human actors that position them for the interactional and material work of collective action’.

Although cognitive participation in the 1000 Lives⁺ programme is underpinned by the MI-PDSA approach, specifically with regard to the promotion of a consistent approach across its multicomponent improvement programmes,424 other resources make valuable contributions. For example, the 1000 Lives⁺ programme team, improvement guides and local and national learning events each facilitate cognitive participation through education and practice-based skill development. Such learning, whether at an individual,187,421,425–427 an organisational12,411 or a system-wide level,24,428 is fundamental to health-care practice change, as is the need for senior organisational leaders to develop a comparable level of awareness of 1000 Lives⁺, the MI-PDSA approach and associated drivers. 429 Cognitive participation thus helps to ensure that systemic and organisational factors giving rise to patient neglect are addressed,430 while knowledge sharing and trust are enhanced. 431

Collective action

The cognitive participation of social actors gives rise to collective purposive action aimed at some goal. However, with respect to the 1000 Lives⁺ programme, such goal-orientation may include resistance, subversion or reinvention, as well as affirmation and compliance with the core features of this patient safety programme. The normalisation of 1000 Lives⁺ is, therefore, dependent on institutional and professional work that defines and operationalises the desired features of 1000 Lives⁺, aligned factors which promote or inhibit social actors’ enacting of 1000 Lives⁺ and social actors’ collective investment of effort in such practices. 353

For the 1000 Lives⁺ programme, two processes which facilitate collective action are interactional workability and relational integration. 352 These involve cross-team co-operation,432 notably via enhanced communication;433,434 the development of shared goals, meanings and expectations;435 and accountability and confidence in the internal and external credibility fostered by mandated local and national monitoring of 1000 Lives⁺. Furthermore, given the explicit steps defined in each discrete patient safety intervention, 1000 Lives⁺ represents a valid and recognised practical aide memoire. In this way, the programme helps to increase awareness of patient-related issues, procedures and anticipated risks across functional health-care teams,436 including both public and population health care. 437

Other processes which facilitate collective action are skill-set workability and contextual integration. 352 Skill-set workability describes how work is divided up among practitioners with different but complementary skills. 353 For example, empirical investigation of the WHOSSC, the focal intervention discussed in Chapter 7, supports the view that defined allocation of work, where the assessment of intraoperative blood loss is apportioned to surgeons, patient-specific airways management to the anaesthesia team and sterility and equipment issues to nurses,438 enhances the performance of the operating theatre team. However, such task definition does remain susceptible to entrenched role boundaries and perceived surgical autonomy, which may impact adversely on safety culture. 439 Contextual integration, as the term suggests, refers to the integration of 1000 Lives⁺ within a social context and its interplay with extant structures and organisational procedures. As May and Finch353 point out, integration may not be easy to achieve in some contexts and will require collective effort from those involved.

Reflexive monitoring

Practices, even when established, demand reflexive monitoring to ensure appropriate performance. 338,353,440 Patterns of collective action, and their outcomes, are therefore continuously evaluated by participants in implementation processes, both formally and informally, and with a greater or lesser degree of intensity depending on their interest and involvement. 353 The normalisation of the 1000 Lives⁺ programme in day-to-day practice is, therefore, dependent on institutional and professional work that defines and organises the everyday understanding of 1000 Lives⁺, aligned factors which promote or inhibit social actors’ appraisal of 1000 Lives⁺ and social actors’ collective investment in its ongoing theorisation and refined understanding. 353

Individual and collective reflection of actual practice against explicit and more tacit norms, while central to the embedding of a practice,356,441–444 may differ markedly from formal governance procedures and standards, in some cases giving rise to a façade of legitimacy. 85 Empirical studies of patient safety have also highlighted the human barriers to incident reporting, despite its central role in organisational learning and the establishment of a stronger safety culture. 412 In the following section, we seek to examine the views and experiences of individuals and groups during the institutionalisation of the 1000 Lives⁺ programme, and so to understand the processes involved in the operationalisation, subversion or reconstruction of its associated practices.

Model for Improvement, Plan-Do-Study-Act approach

The central role of the MI-PDSA approach, asserted in Putative mechanisms fostering the normalisation of 1000 Lives⁺, is clearly evident in the study’s participant health boards. This approach provides a recognised framework for health-care practice change and feedback that, through the Improving Quality Together website, benefits from institutional work via the ongoing support of the 1000 Lives⁺ national programme (transcription 5:11, below, and transcription 5:12).

The PDSA approach provides a framework for improvement but you still need leadership, you need ideas and execution, so you’ve still got to generate the will in the people that you’re working with first. Then you’ve got to have change ideas that are based on evidence and not just plucked out of the air – you actually have things that have to be tested – and then you test them; you don’t just assume they’ll work in practice. But the approach gives people the freedom to test them, measure and learn from the process. So, I think, if I was to say anything, it’s a framework, and its helped teams to focus on a name, on a measure, that will tell them whether or not they’re getting towards their aim, and on a change that will hopefully help them to achieve that aim.

Welsh Government, policy lead (033); transcription 5:11

Transcription 5:13, below, describes the role of PDSA in building coherence, cognitive participation and collective action to enable health-care staff to design and deliver practice change.

The model for improvement [MI-PDSA], well it’s, it’s a tried and tested approach, part of improvement science. Look, traditionally we’ve gone: ‘here’s a problem; here’s the solution’, and we’ve tried to fit the problem to the solution even if it involves putting a square peg in a round hole just get on and do it! And, for all sorts of reasons, people don’t just get on and do it because, because things aren’t fit for purpose. So the issue of using the model for improvement is you enable people. You start from the very beginning, you know – you expose the need – you properly measure and identify the problem and enable people to understand that the problem lies with them and that they can do something about it, which is quite empowering. And then, obviously, you guide a solution, and some of those solutions are their own, though most of the time we take an evidence-based practice approach. We introduce them to the evidence-based practice and the methodology – the improvement methodology – so that they can go out and they can get started straight away by having an idea, testing it on one patient one time, one nurse, one doctor! It’s quick and easy, it doesn’t require whole engagement of masses of staff, they can just go out and gradually, gradually build and learn from those very small tests of change and they can adapt existing material to make it fit for purpose. We’ve got the methodology – it’s simple, it’s safe – it requires little or no investment at the beginning in terms of staff resource. There is strong leadership over supporting all of these programmes, so that there is an accountability route, so you can’t just go away and do nothing, there are lines of accountability through local working, through direct and divisional quality and safety meetings, and then through to the steering – the 1000 Lives⁺ steering group – and the quality and safety committee. But it’s simple, the methodology is simple, it’s intuitive, logical, and it’s really enabling people to develop and make the system do what is right to do, easy to do.

Associate Director, case site D₁ (049); transcription 5:13

The inherent simplicity of the approach is viewed to aid its adoption and the sense of local ownership and engagement that underpin its normalisation across NHS Wales (transcriptions 5:14, 5:15 and 5:16). Moreover, as illustrated in transcription 5:17, below, the MI-PDSA approach helps in surfacing the need for improvement, and confidence in the efficacy of its structured processes gives a sense of security that facilitates positive small steps towards change.

Well, I think, fundamentally, it provides us with a focal point to get around the table – to actually acknowledge there’s a problem in the first place – and that we’ve got a structure to follow that’s going to take us in the direction towards solving it. That we might not necessarily solve it in the first place – it might take a couple of times of going through the process to resolve it – but it gives us that format to be able to: it’s a building block to start to look at what the problem is, within a structured way. And I think it’s something, it’s almost like a baby’s dummy, I think it’s something that we just, it’s almost a comfort blanket for us.

Ward manager, case site G₃ (084); transcription 5:17

This markedly positive stance places emphasis on the MI-PDSA’s incremental approach to service development and the empowerment of staff (transcription 5:18). However, two issues countervail: the potential for misuse as an instrument of control (transcription 5:19), and disagreement over the validity of the evidence base for the efficacy of the 1000 Lives⁺ programme (transcription 5:20, below).

1000 Lives⁺ programme team are, in the main, focused on achieving practical, pragmatic activities across NHS Wales which seek to generate service improvements and change. But in NHS Wales, on the other side, you’ve got medical and other professionals – and academics – who work to a completely different standard of evidence in terms of rigorous knowledge-based scientific work: you know how explicit medical or epidemiological statistical modelling is! So, for them, the introduction of 1000 Lives⁺ is, well, it’s completely counter-cultural. The reports that the 1000 Lives programme team were stating were the outcomes of the initial programme, in terms of mortality statistics, well some view it all as some political conspiracy that’s being sold to the NHS, and the public – it’s spin, fluff, crap – it’s not valid data, it’s not collected in a robust manner, it’s flawed. Oh God: please save me from the tyranny of evidence! [What do you mean by the tyranny of evidence?] It’s a killer phrase, isn’t it, in fact it’s the killer phrase. [What do you mean?] It’s used by professionals in health care to stop action, to destroy the potential for change: ‘Oh, we can’t do that, the evidence-base is too weak; their argument is flawed, the data’s mismanaged’. [Anything to maintain the status quo?] Status quo ante! The evidence-based for the 1000 Lives⁺ national programme has been systematically attacked by the other factions – for one side, it’s evidence and truth; for the other, it’s spin and fluff – and reality is caught in the middle.

Policy lead, Welsh Government (081); transcription 5:20

Board leadership, followership and change

Executive-level leadership of patient safety augments the normalisation of the 1000 Lives⁺ programme in NHS Wales (transcription 5:21, below).

If the job of the Executive Team is not about patient safety – organisational fitness, systems, processes, governance structures – then I don’t understand the job!

Executive Director, Workforce and Organisation Development, case site G₁ (012); transcription 5:21

Beyond the board, there is acknowledgement of the need for leaders with expertise in quality improvement methodology to support staff and maintain their commitment to patient safety (transcription 5:22, below). Such roles are, therefore, pivotal for the successful transition of the ownership of the patient safety agenda from the 1000 Lives⁺ programme team to the health board.

My reflection on the PDSA process and instruction is, as a methodology, it’s a very good one. The problem with regards to its application is that you need somebody who is a PDSA expert within the organisation – a leader and change management mentor who can support the various mini-collaboratives with quality improvement methodology – to harness what people are doing.

Associate Director, case site F₁ (026); transcription 5:22

However, some respondents indicated a degree of resentment about the obligatory nature of the 1000 Lives⁺ programme and suggested that such commands to engage may be left unheeded (transcriptions 5:23, and 5:24 below).

The 1000 Lives⁺ national programme and the campaign – it’s command and control rather than a grass-roots culture change – it hasn’t been created by the people. It’s not of the people. It’s an imposition. It’s control. It’s from Cardiff. It’s very much a Cardiff thing that is being pushed to everyone else because: ‘we know better’. Outside Cardiff, it feels remote and distant and not part of us, it’s something that we all recognise as important, clearly, but we don’t necessarily own it.

Consultant gastroenterologist, case site F₁ (T027); transcription 5:24

There was a widespread belief that effective board leadership of patient safety is paramount (transcriptions 5:25 and 5:26) but the importance of clinical leadership of patient safety throughout the organisation, so directing teamwork, communication and collaboration to deliver the desired practice change, was also emphasised (transcription 5:27, below).

Clinical leadership is key – credible clinical leadership – and that’s all about empowerment of band 7 nurses. When we’re in escalation, when beds are crazy, that’s when it’s hard. It’s then you need your band 7 nurses to turn around and tell you what isn’t safe. That’s something we’re working really hard at but that’s a whole culture change. But the 1000 Lives⁺ PDSA cycles did give them a feeling of empowerment that they could make and own changes, they could take chances in the way that suited their ward or theatre or wherever they were doing it: it wasn’t that we were telling them how to do it, it was about them trying it and seeing how it worked, and changing it until it did work in their area. So, I think that they, the areas that did feel empowered through 1000 Lives⁺, combined with the data that they were collecting, well they knew whether they were doing something good or not, and those two things would motivate change.

Associate Director, case site A₂ (T069); transcription 5:27

Teamwork, collaboration and emancipation

For health-care practitioners who have invested meaning in the 1000 Lives⁺ programme, and who adhere to its practices, the programme functions as a rallying point, building collective action and ensuing teamwork. This aids collaboration and communication across different areas of the employing health board and represents an important aspect of the institutional maintenance work that helps to reproduce the norms and beliefs inherent to 1000 Lives⁺ (transcription 5:28, below, and transcription 5:29).

There are other nurse managers and practice development nurses within the organisation that I tend to work with quite closely. For example, with my colleague in surgery, we delivery similar sort of teaching about 1000 Lives⁺, so we link up and deliver sessions together. That way we could pull staff from both of our Directorates, increase numbers, and it’s easier when you’ve got someone else there. We also meet as a group four times a year, so any development and training needs, and that kind of thing, can be discussed and we can agree how things may be taken forward. I know certain of my colleagues were very heavily involved with the SPI [Safer Patients Initiative] work and the first phase of 1000 Lives – they delivered all the corporate training around the PDSA methodology and that type of thing. They’re good contacts to have!

Ward manager, case site D₁ (T010); transcription 5:28

In teamwork situations, the 1000 Lives⁺ programme is perceived to empower health-care staff in roles traditionally subordinate to the profession of medicine. The emancipation of these staff helps to break down the entrenched barriers that prohibit challenge and scope for change (transcription 5:30, below).

1000 Lives⁺ gives them [nursing staff] the freedom to question, which they might not previously have had the confidence to do, as it gives them a format to do it and it’s standardised. Also, you get less challenge back when you are questioning something because everybody here’s been exposed to 1000 Lives⁺.

Theatre manager, case site A₁ (T008); transcription 5:30

Empowerment and engagement with others similarly motivated by 1000 Lives⁺ is seen to have led to patient safety improvements (transcription 5:31). However, there is a view that the latent potential of staff is yet to be realised in NHS Wales (transcription 5:32, below).

I think the key to the next step is, if you like, taking the stabilisers off the bike. 1000 Lives⁺ has supported staff to do specific projects and that has enabled them to have the confidence to say: ‘this is why, and this is how we’re going to do it’. The next step is: ‘this is my idea, and this is what I want to do’. But how is that picked up and supported by the organisation when it’s not an external prompt is the question. I think the NHS is quite bad at thinking about change normally because we’re reeling from it being imposed.

Associate Director, case site G₁ (T011); transcription 5:32

Building the ethos of patient safety: pride and shame in health-care practice

During discussions with the wide range of health-care practitioners interviewed across NHS Wales, the 1000 Lives⁺ programme appeared to be aligned with feelings of both pride and shame in health-care practice.

On the one hand, a strong sense of achievement is depicted in transcriptions 5:33 and 5:34 (below) and highlights the reinforcing role of individual reflexive monitoring – and objective success – in fostering meaningful engagement.

Our last pressure ulcer was approximately – we’ve had two in the last three and a half years – we’ve got a very good record. I’m so proud of our record on pressure ulcer prevention. We have nurses, now, who’ve never seen pressure ulcers. I’m really proud of it. I have this massive thing about pressure ulcers; I have a zero tolerance of them!

Nurse manager, case site A₂ (T058); transcription 5:33

If you’ve had 300 days free of MRSA [meticillin-resistant Staphylococcus aureus], C. diff. [Clostridium difficile] or pressure ulcers in this organisation, it is celebrated with cake! I think, maybe a few years ago, I might have been: ‘that’s a bit gimmicky’ but, actually, the feedback from staff and patients is really positive, and we make sure that patients are involved in that celebration. So, we’ll do media, some publicity around it as well, there’s always features in our local press about a team, ward or department that’s working particularly well. I think that’s positive for our organisation but actually it’s positive from a public perspective because it gives some confidence in the service. Too often bad news is good news, isn’t it?

Associate Director, case site A₁ (T025); transcription 5:34

Indeed, receiving praise for their efforts is seen as central to staff’s continued motivation and commitment to 1000 Lives⁺ (transcription 5:35).

This positive stance is, however, balanced by the use of blame and shame, prompted via the reporting mechanisms inherent to its governance structures across NHS Wales (transcription 5:36).

Another respondent spoke of the ‘desensitising’ effect of being perceived to fail, suggesting that this led to an exaggerated determination not to go beyond the strict parameters of their current task (transcription 5:37, below).

Rather than bad practice being done, there are less opportunities for good practice. People are becoming desensitised by public perceptions of failure. It is normal, now, to sit next to a phone and not answer it because it isn’t going to be for you, and you’re going to be interrupted from your job. The nurse is in a tabard saying do not disturb me on my drug round; that’s wonderful, but you’ve got three consultants doing their ward round too! In the good old days, a sister or staff nurse would come round with me. Now, I’ve got to try and find a nurse and all you get is: ‘it’s not my bay, I’m sorry, I’m on Bay B’, so they don’t know the patient – how many nurses does it take to change a light bulb? Oh sorry, that light bulb isn’t in my bay – it’s that compartmentalised. The sisters have got an awful time; they’ve got, they’re getting kind of beaten at all ends. The number of staff you have on the wards – the ratio of nurses to patients has gone down – apparently, there’s some paper which says that’s safe but then there’s all the other things as well. I think that’s, you know, that’s the concern.

Consultant, palliative medicine, case site A₁ (T052); transcription 5:37

In addition, for those who welcome the new emphasis on patient safety and take a pride in adhering to the precepts of 1000 Lives⁺, there may be a deep sense of shame when failures in patient safety do occur (transcription 5:38, below).

So, with 1000 Lives⁺ we thought we’ve cracked it, it’s done! But I was walking out of the ward one evening at about 9 o’clock at night, and we have, always on our ward, we have a policy of putting our safety crosses in the public area. So, I was walking out of the ward and I saw this red square on the pressure ulcer monitoring, and I said to myself: ‘some idiot’s made a mistake on the safety cross’. I went back into the ward and they said: ‘no, actually, we’ve had a pressure ulcer’, and we all wanted to cut our wrists, really, it was a very depressing moment.

Consultant surgeon, case site B₁ (T062); transcription 5:38

The ethos of care stimulated by the 1000 Lives⁺ programme is, therefore, constrained by the fragmented nature of its normalisation. As expressed in transcription 5:39, and more so in transcription 5:40 below, there is a profound disjuncture. For some, 1000 Lives⁺ and its associated MI-PDSA approach have been actively embraced, resulting in its progressive normalisation: 1000 Lives⁺ is, therefore, absorbed into daily practice. Yet for others, although its mandated nature enforces engagement, this has been resisted: 1000 Lives⁺ is, therefore, only adsorbed onto (i.e. there is token commitment only and it is not properly integrated) daily practice – and, in this transitional state, it may fail to institutionalise across NHS Wales.

Sometimes it can feel we’re doing 1000 Lives⁺ for the sake of 1000 Lives⁺! Well because, you know, people don’t necessarily see their mini-collaborative within the context of the overall quality improvement, patient safety improvement – reducing waste, variation, and harm from the policy perspective – and I don’t think as an organisation we’ve been very good at placing those mini-collaboratives within the context of the overall quality improvement and patient safety improvement agenda. I think that’s why – it just sometimes feels like one of those stand alone things that people do – and, I think, we’ve lost a trick.

Associate Director, case site F₁ (T026); transcription 5:40

Mortality reviews, WalkRounds and patient stories

As outlined in Chapter 1, health-care quality and patient safety demand effective and co-ordinated leadership from politicians,448,449 executive-level managers81,450 and their subordinate staff – whether corporate or clinical professionals451 – who interact with patients, directly or indirectly,4,88,204,452,453 in the coproduction of their care. 146,155,454 Health-care leadership is, therefore, inherently distributed30,36,455,456 and complex,457 and necessitates active followership. 458 Furthermore, it is modulated by a range of other factors which impact patient safety and the culture of care,459–461 most notably (i) organisational governance processes, audit and monitoring systems;462–465 (ii) management processes and their reception by staff;29,466–469 (iii) team-centred learning and local commitment to education;11,207,470–474 (iv) an individual and collective focus on practice innovation;43,475 and (v) the development of an organisational culture of care, wherein transparency, communication and mutual respect are valued. 22,476–478

Structural conditioning: structural and cultural emergent properties in the Welsh health-care field

Initially, we discussed the dominant structural and cultural influences impacting health board-level actors during the institutionalisation of the 1000 Lives⁺ programme and ILQI with policy leads in the Welsh Government. As commented in transcriptions 6:01 and 6:02 (below) – and as previously reflected in transcription 4:01 – the 1000 Lives⁺ programme was deeply integrated with health-care policy development in Wales.

The 1000 Lives⁺ national programme has been a vehicle to do lots and lots of things; it’s been very useful. Now, for pretty much all projects – when we get to the stage where there’s some policy that we need to do in Welsh Government and, I think, even more so following Francis – the implementation is designed with the methodology that sits behind 1000 Lives⁺ in mind because it’s there, and people can understand it, and so they can use it in order to be able to move stuff forward.

Policy lead, Welsh Government (145); transcription 6:01

What we’ve started to introduce this year – this new financial year just started – is we’ve tweaked the tier 1 targets and we’ve created basically five domains of quality. So we’ve tried to reflect much more broadly what boards are doing. We’ve piloted alongside it the principle of what I would call a bit of improvement methodology. We’ve sort of laid out a series of matrixes or grids of competencies that we expect boards to be able to display on a scale of 1 to 5 – a scale of maturity – so what we’re trying to do is to move it away, a bit, from just target driven to being more about development. As I’m trying to make it more developmental, it is starting to get closer to the 1000 Lives⁺ type approach.

Policy lead, Welsh Government (146); transcription 6:02

Such policy actors held robust views on the dominant structural emergent properties impacting health boards: ‘it’s finance, reconfiguration, staffing, and health-care quality performance’ (transcription 6:03, below).

What are the structural constraints on the 1000 Lives⁺ national programme? That’s an interesting question, we could probably spend the next hour just discussing that; but I’ll do my best to be succinct. The first structural constraint is, obviously, the financial difficulties that all public services now face in light of the global economic downturn. Second, for NHS Wales, it’s the major reconfiguration, and that’s still ongoing, as we have to address the configuration of services and their provision across Wales, so there’s a ripple effect across all health boards as they reconfigure. All that will create heated political and public debate because, in Wales, as elsewhere, people are fiercely protective of their health-care services – they still criticise them – but they don’t want services shifted to other sites away from their locality. That creates staffing constraints for all health boards, especially those further off the M4 corridor. As I’m sure you are aware, there are major difficulties in some areas of Wales, in terms of the recruitment and retention of general practitioners, some acute specialisms, accident and emergency, and others. And then, of course, we have the Francis Report, which, I believe, will heighten governance and performance management systems, as we saw after the Kennedy Report into Bristol Royal Infirmary. So, it’s finance, reconfiguration, staffing, and health-care quality performance, they’re the main ones, at least!

Policy lead, Welsh Government (143); transcription 6:03

Financial constraints were also seen to have a specific adverse effect on patient safety (transcription 6:04).

Beyond the goals of 1000 Lives⁺ and ILQI, these acknowledged structural constraints shaped the strategic context to the delivery of the Welsh Governments’ tier 1 targets, and their active management and mitigation was central to the bureaucratic control exerted over each health board (transcription 6:05, below).

[How do you hold NHS Wales’ health boards to account for their performance?] We have an escalation framework – basically four levels of escalation, five if you include zero – we monitor health boards, as they have to perform against the targets that they’re supposed to achieve, and if they’re performing against all of the standards then they wouldn’t be escalated. Basically, they’re allowed to get on with it and, to a degree, we actually pull away from the level of assurance that we seek. So we could get to the stage where you might only, you know, touch them quarterly or half-yearly. But we’re not at that point with anybody at the moment. Once things start to go wrong – somebody’s missing their targets – we then escalate to level 1, 2, 3 and up to 4. At each of those levels there’s a slightly higher level of intervention. Each of these would be just a bit more forceful: ‘you need to have got to a recovery plan by this’; ‘we need you to be showing you’re doing a recovery plan’, if they don’t do that they go up another level and that carries on and the frequency increases. Basically, by the time we’ve got to level 4, the chair will probably be having conversations with the minister, and the chief executive will be probably having conversations with the chief executive of NHS Wales. Throughout this process what we’re looking at is, essentially, what have we got to do with this board; is there something that’s needed in way of turning around behaviour, turning around attitude, turning around performance? Does that mean we have to bring something or someone in? We can bring to bear quite a lot of sanctions, in terms of alterations to their allocation of money. Now, we don’t normally get to that stage but we’re very close with a few boards at the minute – we do have to recognise, as is happening in NHS England, that performance is very difficult in the current financial environment – so the whole system is just basically not quite as slick as it would have been even a year ago.

Policy lead, Welsh Government (146); transcription 6:05

Another respondent viewed the Francis Report to have been the main cultural impact on health boards during the institutionalisation of the 1000 Lives⁺ programme and ILQI (transcription 6:06).

Other structural and cultural constraints arose from the institutionalised delegation of strategic oversight of patient safety – and, thus, 1000 Lives⁺ and ILQI – to the leadership of directors and associate directors of medicine, nursing, and therapies and health science (transcriptions 6:07 and 6:08, below, and transcription 6:09).

Post Francis, I think that the cultural constraints which will impact on NHS Wales’ health boards and 1000 Lives⁺ national programme stem from driving forward a transparent culture of compassionate care – we’ve set out our views on that – so, that is all about the professions, their traditional practices, turfs and turf wars, recognising that errors do happen, and that we can make change to mitigate some of them, though it will take real leadership and time to change the culture.

Policy lead, Welsh Government (145); transcription 6:07

The quality of our services and patient safety issues, though they fall within my remit as accountable officer, are delegated to other board members. You’ll find this across NHS Wales. Certainly, for 1000 Lives⁺ it’ll be the medical director, nursing director, and the one for therapies and health sciences – or whatever title is applied for this type of board-level role – that hold the strategic focus for the patient safety agenda. Typically, it’ll be their associate directors who will be more involved, operationally, in the roll-out of 1000 Lives⁺. This isn’t an abdication or abrogation of responsibility, it’s delegation through to the clinical professionals who ultimately deliver care to patients and whose practices 1000 Lives⁺ is attempting to transform. [What about your engagement in mortality measurement, WalkRounds, and use of patient stories at board level?] Yes, we do those. But that is only part of what we do, there’s more to managing this health board than addressing 1000 Lives⁺.

Chief Executive, case site A₁ (078); transcription 6:08

First-order emergents for board-level actors central to the institutionalisation of ILQI

The dominant structure and culture described in the previous section shaped the context and conditioned the actions of the board-level directors and associate directors central to the institutionalisation of the ILQI. Below, we set out how actors in such professional role-positions reflected on first-order emergents such as their delegated leadership of the ILQI, their vested interests and perceived opportunity costs associated with various courses of action, and seek to discern how this shaped their interpretive freedom and scope for purposive action to support patient safety.

Second-order emergents and situational logic

In case sites A to D, the interplay of structural, cultural and agential emergent properties impacted on the three groups of actors central to the institutionalisation of the 1000 Lives⁺ programme and ILQI. Structurally, the presence of necessary and internal linkages of a complementary nature between structures such as the mandated bureaucratic performance management systems and associated 1000 Lives⁺ and ILQI goals, notably the RAMI, which was integrated into local mortality measurement practices, rendered these performance management and governance institutions mutually reinforcing. Similarly, structural resilience emerged from the co-ordinated action of directors of medicine, nursing, and therapies and health sciences, as collective champions of 1000 Lives⁺ and the broader patient safety agenda.

Second, at board level, the institutionalisation of 1000 Lives⁺ and ILQI draws professional logic into alignment with that of the bureaucratic state. Moreover, there is coalescence and cohesion across medical, nursing, allied professional and health-care management logics. This places each into a complementary stance, fosters the cross-cultural systematisation of facets of 1000 Lives⁺ and ILQI across NHS Wales and promotes the reproduction of such practices across each health board. Consequently, at board level, the ILQI operated under a situational logic of protection that moulded sociocultural interaction, agency, strategic negotiation and the ensuing mode of institutional work.

Sociocultural interaction: agency and strategic negotiation

A situational logic of protection emerged from a context of necessary and internal linkages of a complementary nature between systemic structures and harmonising logics. However, given the status of the people involved, the inherent change agenda overarching the 1000 Lives⁺ programme and, thus, the ILQI were executed from a position of high negotiating strength. Below, we highlight this complex interplay in both a discrete case site and across multiple case sites, drawing out different degrees of bureaucratisation and normalisation to help understand the interplay of the focal intervention, context and mechanism.

Structural elaboration or reproduction in the Welsh health-care field

We also sought to gauge key actors’ perceptions of the structural elaboration or reproduction that had emerged under a situational logic of protection. A national programme team member described how, through the formalisation of ILQI, a network of patient safety leaders, health-care professionals from managerial, medical, nursing and other allied groups, had evolved (transcription 6:38, below).

Well, throughout the 1000 Lives campaign and 1000 Lives⁺, there were some specific interventions that were focused on board-level leaders. But we quickly recognised that, actually, the people that we needed to get at were often senior leaders who didn’t have a formal board-level role. Another thing was that, because of the level of disruption with the NHS in Wales – due to the reconfiguration – there weren’t people in all the formally appointed board roles, so you had a much more, a looser coalition of senior leaders that we needed to engage with. But one of the things that we have recognised, increasingly, is that to achieve a connection between the clinical teams working on programmes and an organisation level focus involves much more than board-level leaders and front line leaders. It involves a network of people throughout the organisation.

1000 Lives⁺ national programme team member (089); transcription 6:38

This notable structural change, in indoctrinating others, promoted the distributed leadership of patient safety and the local integration of the 1000 Lives⁺ programme at each case site. Furthermore, the structural change associated with the integration of mortality reviews into the Welsh Government’s performance management framework was viewed to have added an important ‘critical lens’ through which to view patient safety, providing a valued means of organisational learning (transcriptions 6:39 to 6:41).

In contrast, cultural change was viewed as far more fragmented. This was viewed as owing partly to the pejorative perception of 1000 Lives⁺ as a nurse-dominated agenda and partly to the time demanded for such cultural evolution, if not revolution (transcriptions 6:42 to 6:44, below).

One success is that it’s certainly been embraced by the nursing profession but I’d like to see it embraced by the multidisciplinary teams in a broader context. Some of the other professions are quite dismissive: ‘it’s a nursey-nursey thing’.

Policy lead, Welsh Government (140); transcription 6:42

I do think we have driven structural change through 1000 Lives⁺ but, I think, cultural change is slower. It’s happening, no doubt, and the new website will, I hope, help NHS Wales to build a workforce that has a detailed understanding of service improvement – the skills and knowledge, the capabilities to sustain patient safety – and the sense of empowerment to act.

Policy lead, Welsh Government (145); transcription 6:43

That notion, that simple acknowledgement that, in the Welsh NHS, we do harm. It’s politically difficult to stand-up and say that but I believe it’s the start of real culture change: a revolution in care.

Policy lead, Welsh Government (081); transcription 6:44

Importantly, the cultural change that was in play included some notes of discord. For instance, the means of guiding care could become an end in itself, much to the detriment of the patient (transcription 6:45, below).

The nurses have become conditioned, in some respects to, if they’re having a problem with a patient, they reach for a piece of paper to document behaviours. So I’ll give you an example of one of the recent wards that I’ve been working on – it’s a very, very busy trauma ward – and we have a big problem with older people becoming delayed transfers of care because it’s difficult for us to discharge older people, with high intensity needs, out into a more appropriate setting once their orthopaedic and the trauma care is finished.

One of our patients on this particular ward has, is completely dependent, unable to verbalise her needs or her wants, bed bound, reliant on us for everything, from feeding, to turning, to toileting, to trying to interpret communication. And in that, clearly, she becomes very frustrated. So she’s taken to grabbing out or grabbing nurses as they’re turning her. Instead of the nurses stopping and thinking how can we better interact with her, and how can we reassure her more, they’ve reached for a behaviour chart. So now her behaviours are being documented – instead of actually stopping and thinking about what can we do differently – let’s document the bad behaviour is their response. I think, as a nurse leader, that’s what we’re conditioning our nurses to do.

Associate Director, case site C₁ (119); transcription 6:45

In addition, some aspects of WalkRounds and the use of patient stories were found wanting. For some respondents, WalkRounds were centred on ‘good news stories’ that lacked feedback and action at ward level rather than providing a means for transparent and open discussions (transcriptions 6:46 to 6:49), and ownership of the voice behind the patient story was a source of concern for others. However, overall the 1000 Lives⁺ programme’s ILQI was considered to be a catalyst for change (transcription 6:50).

In Wales, the NHS is characterised by a management style which is probably best described as pace setting, so it tends to have a pace setting management style. And 1000 Lives⁺ and collaborative working and engagement with the public and all of those sorts of things, is more about a coaching style. So for me, it’s getting that right balance between targets setting a pace and underpinning it with something, which then coaches people at the best way of how they can do those maturely, so it’s how we go about bringing that together, which for me is the absolute challenge that we’ve got. And it seems very easy to say that but when you think of the characteristics that you’re changing to do that, it’s immense.

Policy lead, Welsh Government (146); transcription 6:50

World Health Organization Surgical Safety Checklist

The WHOSSC evolved from the Safe Surgery Saves Lives initiative, established by the World Alliance for Patient Safety as part of the World Health Organization’s (WHO) efforts to reduce the number of surgical deaths across the world. This initiative sought to harness political commitment and clinical will to address important safety issues. The principal concerns were poor communication among team members; inadequate surgical and anaesthetic safety practices; and avoidable surgical infection. 531

As illustrated in Figure 19, the WHOSSC is characterised by simplicity and brevity, and is composed of a series of questions to guide the co-ordinated actions of the theatre team. Notably, many of the individual steps advocated are accepted as routine practice. But, as expanded below, such acceptance does not reduce the barriers to its collective adoption. 531 It is, therefore, acknowledged that to foster engagement and enhance compliance,532 each theatre team must adapt the WHOSSC to their needs and routine operative workflow and to address many different types of surgery. 533–545

FIGURE 19.

The WHOSSC. Source: http://whqlibdoc.who.int/publications/2009/9789241598590_eng_Checklist.pdf. Reproduced with permission.

With increasing acceptance of the WHOSSC,546 aligned approaches have been adapted to address broader surgical issues and hazards. 547–550 There have also been more subtle changes such as the adjustment of the timing of questions likely to cause anxiety to patients. 173

Since its inception, the WHOSSC has proved to be a robust means of reducing perioperative complications. 70,406,551,552 Empirical research supports assertions that the WHOSSC (i) saves lives;553–557 (ii) improves communication across the surgical team;558 (iii) reduces the occurrence of wrong-site surgery;63 (iv) promotes adherence to defined antibiotic protocols, thereby reducing the incidence of surgical-site infection;559–561 and (v) fosters more efficient use of theatre time and resources,556 while supporting appropriate staffing levels. 439

Despite such obvious benefits, operationalisation of the WHOSSC may be poor. 70,190,562–564 Failures to follow the checklist include not identifying the patient; undertaking a wrong-site surgery or procedure;565 and failing to identify staff members. 123,566 In addition, pressure of time may lead to surgical procedures being started before the checklist is completed. 567–569 Failure to complete sign out is another common deviation. 122 Poor engagement by anaesthetists,71 surgeons570 and nursing staff due to resistance and gaps in knowledge has also been reported. 435,543,571

Structural conditioning: structural and cultural emergent properties in the Welsh health-care field

Completing the WHOSSC surgical checklist was a compulsory element of the overarching policy mandate of the 1000 Lives⁺ national programme (transcription 7:01, below).

1000 Lives⁺– well, it’s not rocket science by any stretch of the imagination – it’s an incredibly simple approach and that is one of the reasons why it works. The PDSA cycles and all of that stuff it’s created a language that they like: it’s language that they all understand. The WHO checklist just adds another element to it, which is recognised world-wide. It’s mandated as a practice – in policy and professionally – so they’ve just got to do it. After all it saves lives, we know it saves lives.

Policy lead, Welsh Government (146); transcription 7:01

In addition, the WHOSSC was strongly advocated by the WHO, the IHI and the array of associated medical professional Royal Colleges, placing the dominant logic of the bureaucratic state into close alignment with that of professional medical logic within the theatre environment (transcription 7:02, below).

The WHO checklist – it’s compulsory – so it was a little bit more straightforward because, at the end of the day, if people didn’t comply then they were in breach of contract with their controlling body. So that was it, essentially.

Consultant surgeon, case site D₁ (083); transcription 7:02

Such structural constraint was amplified by a parallel programme, Transforming Theatres, representing a Welsh adaptation of the NHS Institute for Innovation and Improvement’s Productive Series, The Productive Ward and The Productive Operating Theatre (transcription 7:03).

The dominant cultural emergent properties, which moulded the institutionalisation of the 1000 Lives⁺ RSC and WHOSSC, arose from the institutional system of the theatre departments in case sites A–D. First, such theatre departments were perceived to function in relative isolation within the base hospital and parent health board (transcription 7:04, below).

Theatre attracts extroverts – you wouldn’t work here if you didn’t have thick skin and couldn’t deal with some of the issues that we have to deal with – but they feel quite isolated from the organisational agenda in a way. Theatre is its own little world. There isn’t that link between the theatre and the rest of the wards, and the larger organisation. But there is a link across the different operating theatres in the health board even though they are all different.

Theatre manager, case site A₁ (008); transcription 7:04

The perception of a distinctive functional and professional culture underscored this sense of separation (transcription 7:05) and this second cultural emergent property fostered the potential for conflict. Across each case site, the traditional view that the surgeon was in charge still lingered. This created a schism: a managerial logic aligned to the nursing profession versus a counterpoised stance aligned to surgeons and their medical colleagues. This tension was not a key issue at all case sites. However, such institutionalised professional role-positions arose as a perceptible fault-line throughout many discussions (transcription 7:06, below).

In theatre, traditionally, the surgeon was the captain of their ship – they ran the show and all the rest of it – and people just did their bidding. But today that’s completely the wrong way round! That’s completely not what modern surgery’s about because you’re only as good as your parts. Now a lot of people won’t believe that still! So if you’re trying to get people to implement the WHO checklist and yet they believe that everything depends on them performing correctly and that they don’t make errors [laughs] then it’s a very difficult task! You’re far more likely to engage with people that actually are slightly less self-assured because they understand there may be a better way to improve the care of the patients. So my gambit with some of my colleagues was to say: ‘I’m not as perfect as you – but do you know your error rate? Are you perfect? Are you one in a million perfect? And if it is that one in a million then what are you going to do to improve’– but people have to accept there’s a problem before they’ll look for a solution. I think they have to see that it’s a problem before they’ll change their practice.

Consultant surgeon, case site A₁ (063); transcription 7:06

Such cultural constraints highlight the critical role of agential emergent properties. Most notably these include leadership and orchestrated collective action within the multidisciplinary theatre team to address perceived problems (transcription 7:07, below).

There was a surgeon I worked with – an orthopaedic surgeon – who I really respected. One day, because I’d just been on a course and knew the proper way of doing the procedure he was going to do, I realised he was going to use the wrong approach. Basically, he was going to go in from the other side of the leg. I knew he was wrong, so I told his registrar, because I couldn’t tell him. The registrar knew he was wrong, and he couldn’t tell him. That’s the example I always use with theatre clinicians: ‘if the most senior consultant was just about to stick a knife into someone, and the most junior member of the department walked in and said – excuse me, stop – what would be the response?’ Would the response be: ‘OK, what have you got to say?’ or would it be ‘get the hell out of my theatre’ with somebody throwing something at him? That usually raises a smile, and once you start talking about it, they realise that the teams that they think were good teams are actually not. Getting back to my example, I said to him in the end: ‘Mr [Name], so you’re using the medial approach today, are you?’, and it was as if somebody switched a switch on in his brain. You could see him almost like come awake and go: ‘no, I think I will go in laterally’. But he couldn’t say to me, you know: ‘thanks for that, I was going to make a mistake’ – we both had to play the game – this whole thing about hierarchies!

1000 Lives⁺ national programme team member (041); transcription 7:07

Consideration of the underlying contextual strata at the interpersonal and individual levels further reveals the impact of this cultural fault-line and exposes the deeply held belief systems anchored to such discordant professional logics. Different cultural stances could lead some individuals to pay little attention to the RSC and WHOSSC. For instance, it was reported that some consultant surgeons did not believe the WHOSSC to be necessary and, thus, viewed it as little more than a management weapon to exert control (transcriptions 7:08 and 7:09). As succinctly expressed in an excerpt from transcription 7:10, below, the institutionalisation of the WHOSSC was dependent on flattening the professional role-based hierarchy in the theatre department.

Our theory on it is if people get the briefings right – where they develop a real team by flattening the hierarchy – and there’s respect for everyone in the theatre, the whole checklist sails through! People start to understand – they’re not worried about challenging a surgeon – they see the value of it!

1000 Lives⁺ national programme team member (041); transcription 7:10

First-order emergents for key actors central to the institutionalisation of the World Health Organization Surgical Safety Checklist

A distinctive set of structural and cultural emergent properties shaped the context in which individuals who were central to the institutionalisation of the WHOSSC found themselves and conditioned their ensuing actions. Deeply entrenched professional role-positions orchestrated the operation of the theatre departments, and we asked theatre managers, consultant surgeons and anaesthetists, and theatre nurses to reflect on their placement, their vested interests and the perceived opportunity costs associated with various courses of action to determine how this shaped their activities.

Second-order emergents and situational logic

In case sites A–D, the interplay of structural, cultural and agential emergent properties impacted on the three groups of actors central to the institutionalisation of the 1000 Lives⁺ national programme, the RSC and the WHOSSC, enabling or frustrating the position they adopted and their role in implementation.

Where structure was concerned, the RSC and WHOSSC emerged into a context moulded by internal and necessary linkages that reflected both complementarities and contradictions. However, as illustrated in the transcriptions above, culturally there was deep discord as the key actors were confronted by the constraining contradictions (necessary incompatibilities) between the dominant logic of the bureaucratic state with its aligned professional health-care management logic versus that of professional medical logic. This led to development of a situational logic of correction/compromise, where those tasked with the implementation of the WHOSSC confronted a context fraught with the power play of different professional groups and had to act in a manner that sought to ameliorate this sociocultural constraint.

Sociocultural interaction: agency and strategic negotiation

At each case site, the situational logic of correction/compromise motivated an essentially concessionary negotiating stance among the key actors. Below, we elaborate two features in depth to highlight this complex interplay across multiple case sites.

Structural elaboration or reproduction in the Welsh health-care field

In examining the contested institutionalisation of the WHOSSC under a situational logic of correction/compromise we sought to gauge key actors’ perceptions of emergent outcomes. Structural change, wrought through the introduction of the WHOSSC and its integration into governance processes, was viewed to have been achieved. However, some interviewees openly acknowledged decoupling from governance processes and the diminishing of the RSC and WHOSSC to a ‘tick-box exercise’ (transcriptions 7:36 and 7:37, below).

As far as the WHO checklist [long pause]. I think it’s disappointing that the figures that are sent in to the centre about compliance bear no resemblance to what’s actually going on out in the service. I just worry that people at the top may be comfortable in the fact that everyone’s having a WHO checklist done and that’s not – that’s not – the case.

Theatre manager, case site C₁ (006); transcription 7:36

I think they saw the benefit but the time constraints get in the way – it became a tick-box exercise – and they weren’t being filled in properly. I remember going round to pick up the form, and seeing someone quickly take it off the stand and tick it, so that data was not really true. The worth wasn’t seen immediately.

Theatre nurse, case site D₁ (113); transcription 7:37

Yet other interviewees, who viewed the institutionalisation of the RSC and WHOSSC pragmatically, perceived structural progress, albeit blended with residual gaps due to professional cultural contradictions. Transcription 7:38, below, captured a cautionary viewpoint that acknowledged that discrete aspects of the WHOSSC had indeed failed to fully embed into daily practice. This reveals an important issue to be addressed when seeking to attain such cultural change: the act of brokering alignment between discordant professional logics demands ongoing creative institutional work to promote the desired alignment and unification at the cultural-system level.

The WHO checklist does work now, generally, but there are gaps. The things that didn’t really take off were things like the theatre briefings before the meetings – they keep being revisited but they keep failing – and they’re trying to relaunch those in [name, different health board] too! They talk about these ‘champion theatres’ of course but nobody knows what champion theatres are! If you ask anyone who’s not in the know – who isn’t a believer – then they won’t have a clue! It’s then very difficult to say: ‘look, the guys in Theatre 3 are doing really good work, can you do the same?’ And they say: ‘well I don’t know anything about it, why should I do that? What’s in it for me?’ It’s compulsory! But even then it won’t be taken care of.

Consultant surgeon, case site D₁ (083); transcription 7:38

In contrast, no pejorative stance muted the perceived success reported in transcriptions 7:39 and 7:40; although the respondent in transcription 7:40, below, was concerned about disparity in theatre department practice, this was mitigated by the belief that auditing such engagement would accommodate, though not reconcile, such variation.

The WHO checklist has been rolled-out across the organisation for some time now and it’s used in each of our theatre suites. But how it’s used is different, it’s different: some of them will do their team debrief on the same day, others will do the WHO meetings all in the meeting, and then it’s managed differently. But whatever they’re doing it’s audited. The activity around the WHO checklist is audited every month.

Associate Director, case site C₁ (119); transcription 7:40

Such varied responses underline the need for leadership and skilled strategic negotiation to broker compromise, contain discord and disregard among the disbelievers and deliver successful change to promote local patient safety practices.

Health-care-associated infection, prevention and control

Health-care-associated infection (HCAI), prevention and control is an issue that impacts on developed and developing health-care systems. 572–574 It is a source of concern for politicians, health-care professionals, patients and the public alike. 575,576 Addressing the human costs in terms of morbidity and mortality is paramount,577,578 but there is also a need to minimise the cost burden incurred through protracted treatment and extended lengths of stay. 577,579–582 A range of patient safety interventions have been designed to improve this problem. 181,583–590 Such interventions typically encompass (i) mandatory reporting and surveillance programmes;591–594 (ii) ensuing targets, standards and performance indicators for IPAC,595–620 especially for high-risk clinical practices600–602 and vulnerable patient groups;603–606 and (iii) heightened control over the use of antimicrobial drugs in the face of the changing epidemiology of HCAIs,589,607–610 exemplified by the rise of MRSA and extended-spectrum beta-lactamase (ESBL)-producing strains of Escherichia coli and Klebsiella pneumonia. 609,611–619

In the NHS, following major outbreaks of hospital-acquired (nosocomial) infection,620 national targets for the reduction of MRSA bacteremias (blood infections) and C. difficile (gastrointestinal) infection are supported by enhanced mandatory surveillance. Oversight rests with the Health Protection Agency in England and Scotland,592,597,621 and, in Wales, the WHAIP led by Public Health Wales. In this manner, IPAC is placed at the centre of clinical and corporate governance. 622 Indeed, the Health Act 2006 Code of Practice mandates adherence to national and local policies and protocols. 623 Zero tolerance of HCAIs624,625 is a primary policy goal.

Core to success is the enactment of good hand hygiene across health-care practitioners, support workers626–630 and patients. 631–635 This standard precaution, perceived to be fundamental to safe health-care practice,636 is captured through the WHO’s ‘five moments of hand hygiene’. 637 These guidelines harness a substantial evidence base in support of hand antisepsis to limit the incidence of HCAIs. 587 However, such education requires regular updating638–640 to promote the adoption of, and continued adherence to, evidence-based improvements,641,642 and monitoring systems are necessary to audit compliance. 595,596,643–645

Although existing studies highlight success in limiting HCAIs48,181 through hand hygiene195,639,646–648 and wider reaching educational programmes,649–653 a high level of non-compliance with basic infection control measures persists among health-care professionals. 654 Indeed, junior medical and nursing staff copy the aberrant behaviour of their superiors,655–657 which results in the entrenchment of non-compliance across successive generations. 655–660 IPAC teams, therefore, have a central role to play in active staff engagement,661 support for peer-to-peer education,662 and the monitoring of HCAIs to reduce the burden of avoidable harm to patients and its associated untoward costs. 581,663–689

The changing epidemiology of HCAIs607,608,611,612,617,666–694 also places demands on medical microbiologists and clinical pharmacists specialising in antibiotic medicines management. 57,671 Collectively, their active stewardship of antibiotic prescribing is acknowledged to limit overprescribing672 and improve adherence to guidelines. 673–676 However, their oversight of surgical prophylaxis is constrained by the charting and timing of the administration of such drugs within the theatre environment. 677–679

There are many other ways in which patients may acquire infections while in hospital. These include the use of invasive medical devices such as ventilators,48,680–710 intravenous and arterial cannulae605,687–690 and various sorts of catheter691–695 However, these sources of infection and the precautions taken to avoid them are not considered in this study.

Structural conditioning: structural and cultural emergent properties in the Welsh health-care field

In contrast to the other focal interventions selected from the 1000 Lives⁺ programme and analysed in Chapters 6 and 7, the discrete interventions selected from RHAI – standard precautions for hand hygiene to prevent the transmission of infection and the use of antimicrobial drugs to ensure the effective prevention and treatment of infection – did not represent practice innovations. The dominant structural emergent properties impacting the RHAI were, therefore, the complex array of established alternative frameworks and the ongoing surveillance of their effectiveness via the WHAIP (transcription 8:01, below).

The question for me is, how do we untangle 1000 Lives⁺ from all of the other elements in play – it’s complicated, confounded – because what’s happening is happening between 1000 Lives⁺, all of the other frameworks and antimicrobial guidelines that are out there, and mandatory surveillance reporting and feedback via WHAIP.

So, it’s through one or a combination of all of those things that the higher echelons, if you like, of hospital management are now faced with infection control, and its importance, much more so than they were 10 years or so ago, or even less than that. So I think, whether it’s due to 1000 Lives⁺, other frameworks, or the surveillance processes in place, I think it’s achieving something – because they have to be aware and address HCAI due to WHAIP reporting to the Welsh Government – my impression is that they are aware of it and they feel accountability.

Now when you have accountability in the higher levels of management, the way that they effect that accountability, quite rightly, is through delegation and spreading the message in terms of what needs doing. The previous medical director here, who was spectacularly engaged, even before 1000 Lives⁺, with the idea of infection control provided a real sense of leadership, and had an awful lot of insight. I don’t know why that was, perhaps he just saw it as part of his role, I don’t know, but he did it very well. But now, now that we’re a lot bigger, and we have a wider range of – I don’t want to use that term ‘lower’ – some of the next tier down levels of management, like director level and their associates or assistants, that message is dissipated.

Consultant microbiologist, case site C₁ (034); transcription 8:01

Other structural issues also surfaced during discussions with respondents, notably the compounding impact of the reconfiguration of NHS Wales on framework alignment, and the need for the co-ordination and consolidation of different guidelines under a health-board-wide and emergent all-Wales remit (transcriptions 8:02 and 8:03, below).

The reconfiguration of NHS Wales, the formation of health boards that’s occurred during the roll-out of the original 1000 Lives campaign and 1000 Lives⁺, I think this has created issues which are problematic. I think that the creation of much larger health boards has created barriers to the roll-out of 1000 Lives and 1000 Lives⁺. So, for example, something that’s seen to be an incredibly high priority within this health board, quite rightly, is the fact that before we were [number] Trusts, and we all had, I imagine, a pretty good spread of infection control policies that were broadly in line, and in their own way ticked the boxes for national recommendations. But they were not the same. Now a priority, here, is that we have harmonised consistent policies. So, you know, we all have workable policies that we could just leave alone to would work on each site; but no, we are required to have single harmonised policies that we all agree to. Now the differences that existed were there for a reason. But now we’ve got to try and overcome those differences, agree amongst ourselves, and then get wider agreement across the consultants. And the point being that that’s a job of work that takes time and is outside the time requirements that might be put into 1000 Lives⁺.

Consultant microbiologist, case site A₁ (035); transcription 8:02

Working with consultant microbiologists, we produce and review the antibiotic policies used across the health board. There’re planning to have all Wales antibiotic policy guidelines. [Have they been produced and published?] No, no way: it’s still at a very early stage of discussion, about 6 months in, and I think it will take years to agree: there’s so much disagreement about what to use, when, and some doctors simply refuse to follow any guidelines, no matter who produces them: ‘where’s the evidence; the evidence is disputed; it’s not that clear cut; it’s my freedom to prescribe how I see fit for my patient’. We get that same old argument, from some of them, all the time.

So, we produce the health board’s antibiotic guidelines and monitor them through audit cycles across each ward or base hospital; we do the education associated with antibiotic usage for the junior doctors, nurses, and other staff, including other pharmacists; and we do antibiotic ward rounds with consultant microbiologists – this is a small hospital, so consultant microbiologists don’t have junior doctors attached to them, so, in a way, we act like their juniors – this involves antibiotic prescribing and follow-up, checking that the drug and indication are appropriate, that the dose, route, are all correct, that sort of stuff. I don’t think of the context outside so much, I suppose; for me, it’s about the people I talk to and work with each day.

Pharmacist, Antibiotics Medicines Management, case site B₂ (001); transcription 8:03

In addition to the structural constraints arising from various existing guidelines, a previous patient safety improvement programme, the Safer Patients Initiative, had a legacy effect which resonated strongly with some IPAC nurses interviewed as part of this study (transcription 8:04, below, and transcription 8:05).

If I’m honest with you, when it [1000 Lives] came out originally, it was a bit of a spin-off from the SPI [Safer Patients Initiative], you know, the IHI approach, wasn’t it?

It came out at the time when we were reorganising the health service in Wales. So, I think, a lot of the correspondence went to people whose positions have changed and so on and so forth. They started off at a very high level but there was a lot going on in the organisations and it didn’t really filter down – the leadership was a little bit fragmented at that time – I think in the last 2 years we’ve sort of taken hold of it.

We were a little bit at odds with the priorities of the RHAI programme initially because we had done our own prevalence survey, internally, and we hadn’t identified problems with catheter-associated UTIs [urinary tract infections]. We did an incident survey over a period of 1 month in wards in the organisation and there were no issues with catheter-associated infections at that point in time. However, we identified problems with peripheral venous cannulas during our point prevalence survey. But the campaign was mandating a focus on short-term urinary catheters, whereas our priority at that time was more to do with peripheral lines. So it was a little bit of, it was a little bit, you know, sort of didactic I guess: ‘this is a priority, and this is what you must do’, and I was thinking, well, in our organisation, this is our priority and we will do that, at the moment we need to focus on that.

Senior nurse, IPAC, case site A₂ (076); transcription 8:04

Such structural constraints were interwoven with the current financial challenge; as one respondent commented, ‘the biscuits are gone!’ (transcriptions 8:06 and 8:07).

The cultural emergent properties impacting staff involved with infection control arose from their different but interlocking roles. It was clear that there was close liaison between each professional group (transcriptions 8:08 and 8:09, below).

I’m aware that there are different models, if you like, with the consultant leading, consultant microbiologist, the infection control doctor leading the service. Here it’s a flat model – a flat model between the lead infection control nurse and the lead infection control doctor – and it is something that I feel not only works well but is appropriate because we bring different skills to the mix, and I’m not sure that any set of skills is more important than the other.

Consultant microbiologist, case site C₁ (T034); transcription 8:08

Well, predominantly, in infection control, our role is for support and advice to staff. That’s our role. But we’re also involved in conducting audits – particularly things like hand hygiene audits, commode audits, environmental audits, and those kind of things – and those are fed back to ward staff, the results and an required action. But we also carry out things like surveillance, so we’ll monitor our alert organisms [for WHAIP]. If there’s any kind of change – an indication that there’s an increase in health-care-associated infections, or an increase in any of our WHAIP alert organism, such as MRSA, MSSA [meticillin-sensitive S. aureus], C. diff, Group A strep [Group A Streptococcus], E. coli, any of the alert organisms, we’ll go and find out, and liaise with the consultant microbiologist.

Senior nurse, IPAC, case site D₂ (017); transcription 8:09

Such liaison also gave rise to professional networks which enabled processes of interprofessional knowledge mobilisation that were perceived to be operating at a more challenging level than those of 1000 Lives⁺ (transcription 8:10, below).

If I’m facing something that new, a bit different to what I’ve handled before, I would first contact other antibiotic specialist pharmacists – there’s a network across Wales – so that would be one source of information and advice. The others, naturally, are the consultant microbiologists and IPAC nurses. Also, there’s a formal meeting twice a year of the Antibiotic Stewardship Forum, which consists of medical microbiologists, pharmacists, and some specialist nurses. They don’t meet that often but they’re a great source of information, and an opportunity to share learning and development.

[Are there any other groups that you would contact for advice or support?] Yes, the UK CPA [UK Clinical Pharmacy Association] is another source of information. They have an infection management group – they’re more advanced in England – there’s a good web site, support materials, that sort of stuff which is very helpful. In England, they have developed the consultant pharmacists role – we don’t have those in Wales yet; but I think one is due to be developed in Renal Pharmacy, which is an incredibly complex field. So that sort of recognition, legitimacy almost, is absent in Wales. Another group is the British Society for Antimicrobial Chemotherapy. They’ve got a useful website, and they run all Wales study days, which, in terms of the evidence and focus, are pitched at a far higher level than 1000 Lives⁺. I feel like I’m learning something new when I attend these, not just being told to wash my hands before I go onto a ward, or to make sure that a course of antibiotics has a defined stop date! Another is the Welsh Microbiological Association and again, they run study days, really focused on education, and this is linked into Public Health Wales. So this is all at a level above 1000 Lives⁺.

Pharmacist, Antibiotics Medicines Management, case site B₂ (001); transcription 8:10

First-order emergents for key actors central to the institutionalisation of Reducing Health-care Associated Infection

Such structural and cultural emergent properties shaped the context in which key actors, central to the institutionalisation of the RHAI now found themselves and conditioned their ensuing actions. We therefore asked consultant microbiologists, nurses specialising in IPAC and pharmacists specialising in the management of antibiotic medicines to reflect on their placement, their vested interests and the perceived opportunity costs associated with various courses of action, to determine how this shaped their activities.

Second-order emergents and situational logic

In case sites A–D, the interplay of structural, cultural and agential emergent properties impacted on the three groups of actors directly involved in the operationalisation of RHAI. First, in structural terms, RHAI was integrated into the social system-level but was overshadowed by existing systems. Second, in cultural terms, though internal and necessary complementarities could be seen between the RHAI and the array of professional logics in play, this was not considered to add much to already existing principles and procedures and was largely disregarded. RHAI, therefore, operated under a situational logic of protection that was primarily directed towards the pre-existing structural and cultural system-level, and thus to sociocultural interaction aligned with long-established practices.

Sociocultural interaction: agency and strategic negotiation

As discussed in Chapter 6, a situational logic of protection is typically associated with a defensive negotiating stance. However, for RHAI, prior systems of HCAI surveillance and developed IPAC practices overshadowed the intervention. The progressive institutionalisation of the 1000 Lives⁺ national programme and RHAI, therefore, unfolded in a terrain marred by a degree of disdain. We highlight this complex interplay in both a discrete case site and across multiple case sites, again drawing out different degrees of bureaucratisation and normalisation to help enrich our understanding of the institutional work complementary to the interplay of the focal intervention, context and mechanism.

Structural elaboration or reproduction in the Welsh health-care field

In examining the progressive institutionalisation of the 1000 Lives⁺ national programme’s RHAI we sought to gauge key actors’ perceptions of the structural elaboration or reproduction that had manifested under a situational logic of protection. For consultant microbiologists, attributing improved outcomes in HCAIs to 1000 Lives⁺ or RHAIs was considered to be very challenging, owing to the interplay and collective impact of multiple IPAC policies on WHAIP’s robust epidemiological modelling (transcription 8:41, below).

If you’re looking at say, catheter care policy, now, looking for it to reduce catheter-associated UTIs [urinary tract infections] then that’s going to be a small subset. So, it’s very, very difficult to be able to draw and demonstrate a reduction. It’s technically possible, if you have a big enough study population. However, practices in hospital are not static, things change, for the better, for the worse, for a whole host of reasons, and controlling any one aspect through 1000 Lives⁺ policy, or something of that nature, that may have one impact but there may be contrary aspects that the main path is working on. So, it can be, I think, very challenging, and very difficult to really show a reduction and improvement in outcomes.

Consultant microbiologist, case site A₁ (035); transcription 8:41

Structural change was apportioned to the ward-based functional health-care team. In enacting RHAI and other IPAC guidelines, such staff not only delivered change (transcription 8:42, below), but were continually motivated to do so through fear of exposure of failings (transcriptions 8:43 and 8:44).

Our C. difficile rates have actually gone down, a reduction again on last year. So it’s good. But, you know, that’s where our support and advice has come in. But at the end of the day, in infection control, we’re not there on the coalface, if you like, it’s the staff who put that into practice, into place, you know, they carry on with what we advise. So, you know, a lot of the hard work is down to them.

Nurse, IPAC, case site D₂ (019); transcription 8:42

Cultural change, by contrast, was perceived to be far more marked, with a professional logic of zero tolerance of HCAIs emerging across NHS Wales, although it remained far removed from the reality of day-to-day health-care practice (transcription 8:45, below).

I think the culture is changing, I mean, I’ve seen it in the short time I’ve been in infection control, the ownership at ward level for infection control has shifted. Whereas, you know, if there was a problem on the ward, often the wards wouldn’t call us, so we would find out by our surveillance!

But now wards are contacting us to say: ‘I think we’ve got a problem’, so there’s the acceptance of their role in infection prevention and control. Before, for Clostridium difficile, it was accepted that it’s just a consequence of being in hospital – the attitude was: ‘what do you expect, you’re going to have antibiotics, you’re elderly, you’re bound to get it’ – but that is changing now. Now people are saying: ‘no, they shouldn’t be getting a health-care-associated infection, it’s just not good enough’. There should be zero tolerance on infection, health-care-associated infection. [But they still happen, don’t they? And patients still die as a consequence, don’t they?] Yes. [Long pause] But I think at ward level staff now are not accepting that patients should acquire an infection as a result of being in hospital.

Nurse, IPAC, case site B₁ (131); transcription 8:45

In addition, though tangential to RHAI, the normalisation of the 1000 Lives⁺ MI-PDSA approach was evident (transcriptions 8:46 and 8:47). However, the crux of such cultural change lay in the education of staff (transcription 8:48, below, and transcriptions 8:49 and 8:50).

Education is key, too, not just education for the sake of antibiotic education but to change the culture. But, again, we face a huge problem here as the attitude is: ‘well, what’s the problem; why do we need to change how we do things; the evidence is weak’, it’s always the same.

I don’t want to sound cynical, I don’t. I love my job. But getting people to change is difficult, especially doctors, though they do know that I know what I’m on about. But we go through the same issues with each junior doctor rotation – I feel that I have to re-prove myself to them because they prescribe, wrongly – I know what they should be prescribing better than they do. So, a large part of what I do is education, and not just about drugs.

[Do you think that the junior doctors respect the work you do?] If they’re arrogant, and think they know it all, probably not; but they’re the most dangerous. Once you’re stopped them from killing a patient, once or twice; once they’ve realised how fallible they’re, and how, within the NHS, you’re lucky if you got a good team around you, who all know their own profession and offer different expertise, they start to listen. They’re not all like it, thankfully. Some are really good, and with more joint training early on in health-care professional careers, I think the issue of professional respect is getting better. But the best doctors are those that listen, and, more importantly, they ask for information and advice, they’re keen to learn, and you know they’re going to be good because they work constructively within the team. But with some with doctors, we often just get point blank refusal to co-operate.

[What are the consequences of this? How does the audit cycle, and associated governance processes intervene to feedback in such circumstances?] Well, the pharmacy audit will be sent to the medical director but, with the lack of prescriber identification, and data aggregation, it gets blunted.

Pharmacist, Antibiotics Medicines Management, case site C₁ (013); transcription 8:48

Contextual organisational factors pertinent to the health outcomes of hospital patient safety interventions

In this section we build on our conceptualisation of a situated context. Informed by our realist analysis of the local implementation of the 1000 Lives⁺ programme’s three focal interventions – ILQI, RSC and RHAI – we identify and analyse the supraorganisational and organisational factors in the Welsh health-care field which are pertinent to the health outcomes of these hospital patient safety interventions.

Mechanisms that interact with contextual organisational factors to generate the health outcomes of hospital patient safety interventions

In this section, first, we reflect on the notion of a mechanism. Then we set out how our findings have identified critical mechanism substructures which impact the local implementation of the 1000 Lives⁺ programme.

Mediation and reflexive theorisation

In defining such mechanism substructures, our findings help to reveal how the structural constraints and enablements of context are mediated to social actors engaged in the local implementation of the 1000 Lives⁺ programme. As expanded in Chapter 2, these influences give rise to four potential second-order emergents, which foster the accompanying situational logics of protection, correction/compromise, opportunism and elimination, thereby guiding the generative mechanisms in play.

Our findings illustrated that the focal intervention ILQI drew professional logic into alignment with that of the bureaucratic state. This fostered the systematisation of 1000 Lives⁺ and ILQI across the cultural system level of NHS Wales and promoted the reproduction of such practices across each health board. Consequently, at board level, ILQI operated under a situational logic of protection that guided sociocultural interaction, agency, strategic negotiation and ensuing modes of institutional work.

The focal intervention RSC, centred on the local implementation of the WHOSSC, confronted a more contested terrain, with the coalescence and cohesion manifest between the views of theatre managers, consultant surgeons tasked with the implementation of the WHOSSC, and theatre nurses, stymied by the countervailing stance adopted by some surgeons. These constraining contradictions (necessary incompatibilities) between the dominant logic of the bureaucratic state and aligned professional health-care management logic versus that of professional medical logic held by surgeons opposed to the introduction of the WHOSSC therefore created a situational logic of correction/compromise. This logic guided sociocultural interaction, agency, strategic negotiation and ensuing modes of institutional work along its disrupted path.

The focal intervention RHAI emerged into a context moulded by internal and necessary linkages of a complementary nature to existing structures. Nonetheless, a situational logic of protection of the status quo ante manifested. Reflexive monitoring was found to be anchored to the past, to preferred and more highly rated organisational and professional processes currently in use. Under these conditions, there was only superficial interest in and action to engage with RHAI.

Development and hypothesis testing of relationships between contextual organisational factors, mechanisms and the health outcomes of hospital patient safety interventions

In this study, we sought to develop and test hypothesis regarding the nature of the relationships between contextual organisational factors, mechanisms and the health outcomes of hospital patient safety interventions. Yet given the ontological commitment to critical realism, set out in Chapter 2 (see Addressing the challenges of realist enquiry, Realist social theory) and Chapter 3 (see Comparative case study approach, Ontological and epistemological alignment to realist analysis), such hypothesis testing was markedly different from that commonly adopted in positivistic studies. In essence, our approach centred on the progressive explanation and refinement of our understanding of the local implementation of the 1000 Lives⁺ programme, and the three focal interventions considered in more depth, all framed through our I-CMAO configurations.

Across Chapters 4–8, this approach revealed the nuanced relationships associated with the bureaucratisation and normalisation of the 1000 Lives⁺ programme, as illustrated in the explanatory schematics and accompanying data tables. What emerged from our data was the role of structural and cultural conditioning on the individual, embedded at the level of the functional team – managerial and clinical – and their ensuing disposition and scope to act to effect institutional change in support of patient safety. Such social structure, understood as the internal and necessary relations between social positions and positioned-practices, gave rise to emergent causal powers as the material cause of social activity. 733–735 Perceived through our non-reductionist critical realist ontological stance, patient safety is, therefore, an emergent property of the micro-level organisation of health care.

In examining the bureaucratisation and normalisation of the 1000 Lives⁺ programme, together with the local implementation of the three focal interventions selected, the underpinning role of the MI-PDSA approach, depicted in Figures 2–11, was revealed. 1000 Lives⁺, together with this core resource, were found to have become ’part of the patient safety language of NHS Wales’ . . . ’PDSA cycles and all of that stuff it’s created a language that they like: it’s language that they all understand’. That, supported by the 1000 Lives⁺ dedicated website, and aligned resources from Improving Quality Together and Patient Safety Wales, now provide the means to spread such practices across NHS Wales.