Altogether this paper reports the synthesis of empirical data retrieved from the case study’s larger unit of analysis (the Quality Improvement Regulation), and its link to adaptive capacity across three system levels [10, 41, 49, 50]. The multilevel case study revealed how the Quality Improvement Regulation was developed, implemented, managed, and inspected across three system levels in the Norwegian healthcare context. Synthesized findings demonstrated that the Quality Improvement Regulation facilitated adaptive capacity, but nevertheless resulted in next to no change neither at the inspector level nor the hospital management level. This makes way for deliberation about how design, and implementation of healthcare regulation best links with adaptive capacity across system levels in order to result in relevant and efficient change and improvement. The latter relates to assumed conflicts between governmental expectations and managerial and supervisory implications [19, 28, 46, 56, 57]. The forthcoming discussion is divided into two parts, with links to all three themes.
Implementing a context sensitive regulation followed up by a static inspection approach
Our study demonstrated that a regulatory regime supportive of contextual sensitivity does not guarantee actual implementation into inspectors’ nor managers’ work practices. We discuss these integrated findings by channeling: i) adapting regulation to ensure system resilience, ii) mismatch between regulatory changes and supervisory and hospital management practices, and iii) different scales of resilience.
Adapting regulation to ensure system resilience
The study overall identified that change was requested and needed, resulting in a regulatory revision. Synthesized findings indicated that the Ministry, and the Directorate, in documents and interviews, confirmed that embedded variation and complexity in healthcare settings required flexible regulatory expectations. This resonates with the resilience in healthcare concept in terms of acknowledging that external conditions may influence system performance, with real situations deviating from expectations [6, 19, 46, 47, 58, 59]. Thus, regulators in our study considered work as done when designing the Quality Improvement Regulation. A regulatory design that amongst regulatees is perceived to be sensible, could stimulate adaptive capacity across macro, meso and micro levels. Our synthesis finds that a collaboration between the system levels to mutually shape regulatory, supervisory, and management practices, may serve as an important collective potential to obtain system wide resilience. Past literature on the subject has highlighted this type of “mutual shaping” [60]. Furthermore, as a complex healthcare system is contained by uncertainty and variation, it seems key to ensure system wide adaptive capacity to meet with unexpected situations. The synthesis thus demonstrates a possible reconciliation between macro, meso, and micro-levels, by ways of seeing the various stakeholders in the system as collaborative partners in a regime of responsive regulation. This moreover implies that different stakeholders play mutual important roles in adapting regulation, to ensure the system’s resilience. This is a novel output in the research field because few studies have examined and contradicted the assumption that regulation and resilience are intractable opposites [6,7,8,9]. A regulatory and supervisory system that aims at regulating processes, through checking that hospitals are adequately undertaking quality improvement, can be considered both a better fit for a complex system and should also build resilience (and responsiveness to local conditions) through being more enabling of adaptations to local risks [6, 61]. As such, the performance-based regime investigated in our study, has great potential in being flexibly applied into hospital management and quality improvement processes. At the same time, it may build potential to foster a systematic process of hospital internal monitoring, anticipating, respond to, and learn from both regular work mode, and adverse events [45].
Mismatch between regulatory changes and supervisory and hospital management practices
The new Quality Improvement Regulation did not lead to changes in the inspectors’ work practices nor in the hospital managers’ work related to quality improvement activities. There was a mismatch between the introduction of the new Quality Improvement Regulation and the need to accordingly develop a new supervisory approach and provide hospital managers with sufficient support. The study hence indicated a potential to refine supervisory methods towards more regulator-regulatee interaction, increase the information exchange between inspectors and hospital managers and clinicians, put emphasis on developing methodology that helps hospital managers in “translating” supervision reports and frame problems into relevant improvement activities, as well as to increase attention to positive experiences and smart adaptations in hospital practice. This output vibrates implications in recent studies about innovation in supervisory methods in general, with special attention to involvement of next of kin and reflexive spaces [10, 15, 41, 49, 50, 62,63,64,65,66].
Different scales of resilience
Macro-level findings displaying the need for a regulatory change held together with micro-level findings, did show that several structural and cultural changes at the hospital level had occurred in recent years. We argue that these changes could link with resilience at different scales of organizational activity [67]. By applying these theoretical scales to our findings, macro-level findings indicated systemic resilience: demonstrating how the previous regulatory regime (the Internal Control Regulations) was reformed by the government into a new, PDSA designed Quality Improvement Regulation. This came as a response to needs proposed at the micro-level. Micro-level findings indicated structural changes as in for instance the recent establishment of different types of patient safety and quality councils in the hospitals. Our synthesis thus underpins that those processes to support change were partly ongoing regardless of the design and implementation of the new Quality Improvement Regulation and partly facilitated by performance-based regulation’s support for flexible management of quality and safety. We argue that responsive regulatory regimes foster adaptive capacity at different scales and therefore may contribute to promote collaboration among different stakeholder levels in healthcare [39, 40]. On the other hand, these integrated findings displayed a paradox as the systemic development was not followed by reported changes in management or supervisory practices.
The complexity of autonomy in risk regulation and resilience
Our study demonstrated that autonomy and adaptive capacity to tailor quality improvement efforts were imperative if the regulatory framework ought to have any relevant impact on inspectors’ and managers’ activities. We discuss the integrated findings by channeling: i) the value of autonomy and management to successful implementation, ii) a regulatory craft focusing on responsive collaboration between regulators, inspectors and regulatees, and III) moving forward.
The value of autonomy and management to successful implementation
Performance-based regulation such as the Quality Improvement Regulation may represent an advantage compared to other regulatory strategies, in terms of supporting autonomy and adaptation to risk and context [10, 40]. As proved in our findings, hospital managers are expected to base their quality improvement measures and risk reducing activities on contextual conditions such as available resources and competences [30]. The ability to plan for, adapt to and anticipate local risks is thus incorporated into governmental expectations and regulatory strategies. As our study established a more nuanced outlook on regulation as governmental behavioral modification, the synthesis therefore counters with a traditional clinician viewpoint seeing regulation per se as a necessary evil and contradictory to autonomy and individual influence [6, 68]. On the other hand, autonomy and freedom to tailor improvement efforts require competence, additional resources, and systems to support hospitals and hospital managers, and responsible application by the regulatees [39, 40, 69, 70]. System’s “software”, including organizational culture, adequate management, and leadership, has shown to be a crucial determinant of quality improvement performance [61, 71]. For instance, micro-level noncompliance to implementation may link with a lack of management competences [72]. Attention to meaning and purpose in management training has therefore shown to be essential in achieving successful implementation in healthcare settings [20, 73,74,75,76,77,78,79]. As clinicians possess firsthand knowledge and experiences with adaptive capacity, past research has also demonstrated the urgency in having clinicians in management roles to get systematic improvement methodology embedded into everyday hospital work [77, 79,80,81].
Our synthesis, advocates for a more thorough understanding of how resources, competences and in-house interpretation support could constructively facilitate implementation of regulatory requirements and lead to long-term structural and systemic changes in the responsive healthcare system. We encourage further research to investigate into this field.
A regulatory craft focusing on responsive collaboration between regulators, inspectors and regulatees
By mapping the complex everyday reality in a regulatory regime in healthcare, our synthesis has sought out aspects that governments need to keep in mind while designing and developing new healthcare regulation.
Our study demonstrates that healthcare regulation is solely sensible if it is inclusive of those who are responsible to implement the strategies and requirements. Previous literature has shown how government audits with lack of attention to local conditions and stakeholder inclusion can lead to de-legitimization of external regulation [17, 40, 41, 79, 81,82,83]. In turn, lack of trust and unwillingness to learn can lead to all kinds of maladaptive behaviors [82]. As our micro-level findings displayed a lack of trust and motivation to learn from external inspection, it seems crucial that regulatory bodies play out a sensible “regulatory craft”. Their craft may influence the regulations’ impact on the regulatees’ behaviour and performance in terms of how regulatees implement a regulatory requirement or change [83]. Linked to our integrated findings, we uphold the argument that performance-based regulation like the Quality Improvement Regulation, seems sensible because it specifies preferences or objectives. It for instance recommends a PDSA approach, without compromising healthcare professional or institutional autonomy to choose appropriate actions and efforts according to relevant risks.
As different problems require different problem-solving techniques, the regulatory craft coincides with principles retrieved both from responsive regulation theory and resilience in healthcare [1, 2, 39, 40, 46, 83]. Central oversight, as in providing hospitals with a set of governmental requirements and regulations on one hand, and independent, local adaptations on the other, reflects how the two sets of ideas are entailed in any healthcare system. By ensuring adaptive capacity into the regulatory regime, it concurrently facilitates anticipation, another resilience potential [45]. Yet again, as our synthesis demonstrates, hospital managers’ ability to adapt and anticipate presuppose administrative and advisory support from the macro and meso-levels. Thus, these capacities’ purpose, namely, to corroborate system resilience, depend on central government support in budget allocations, as well as regional and local administered support to competence building and resources in general. Enabling factors that make performance management constructive have previously shown to be teamwork, self-organizing practices, and shared sensemaking [61]. These collaborative processes call for a double loop learning process. This is a core idea of the PDSA cycle, with focus on getting the information about organizational challenges as experienced by micro level stakeholders, further up the system chain, to meso and macro-level stakeholders [84, 85]. By having attention to information flow as part of the problem-solving, it may eventually lead to reevaluation of policies, regulations, and practices. In this, we find resonance with the resilience potential of learning, as well as connecting to the idea of trying to minimize the gap between work as regulators and inspectors often imagine it to be, and work as done by the regulatees [19, 46]. The PDSA cycle, as found in the design of the Quality Improvement Regulation, may contribute to stimulate reflection and accordingly, foster a recoupling between work as imagined and work as done. This reflexivity is important on all system levels (macro, meso, micro), as well as across system levels (macro-meso, meso-micro, macro–micro). Our synthesis therefore demonstrates that successful implementation presupposes a regulatory craft with focus on responsive collaboration, to reduce the mismatch found between regulatory changes and supervisory and hospital management practices. Performance-based healthcare regulation could consequently account for a balance between the ideal of centralization and the ideal of decentralization and contribute to adaptive capacity in hospital management of quality and safety. Thereby, the craft may foster system resilience.
Moving forward
Overall, what our synthesis showed was that to achieve a regulatory change, illustrated by the Quality Improvement Regulation, set out in a practical hospital context, adaptive capacity, is needed across three system levels. This includes more extensive collaborative efforts both prior to regulatory changes, during development and design processes, that exceeds the regular hearing processes. It also includes innovation to ensure collaboration between regulators and regulatees during external inspections, by increasing the application of expertise-oriented inspectors, recurring use of hospital self-assessment and involvement into implementation evaluation processes. Our study also illustrated that inspectors were expected to master the “craft” of moving between different regulatory strategies [10, 41]. The supervisory system examined may not have the sufficient construction to facilitate the responsiveness and trade-offs inspectors are supposed to handle. These aspects are important take home messages in the understanding of the thorough efforts required from stakeholders across all three system levels to improve quality and safety in healthcare settings. To ensure that the performance-based regulatory and supervisory model of which the Norwegian system builds upon, reflects the complexity it is supposed to regulate, inspect, and manage, we recommend a governmental evaluation of the implications our study has indicated. Our synthesis calls for a demanding systemic adaptive process, to move the current responsive regime forward.
Strengths and limitations
The multilevel case study was based on the argument that various stakeholders at different system levels have different impact on the risk management process [47]. Through information flow and decision-making processes, the system levels are interwoven, implying that researchers need to understand the relationships among the different stakeholders [86]. One of the main strengths with a multilevel perspective is therefore the opportunity to investigate different realities and gain a systems perspective [5]. Accordingly, this synthesis paid attention to different realities at three system levels in the Norwegian healthcare setting. By assuming that integration could emerge from identification and tracking of macro, meso, and micro level participants’ views, expectations, and experiences of the rationale for the revised regulatory regime, in addition to actively look for links to adaptive capacity in the documentary evidence and interview responses, both bottom-up and a top-down perspectives were nurtured in this synthesis [87]. However, our study has some limitations. We did not limit our study to either specialized somatic healthcare or psychiatry but included managers from both areas. Considering differences in the arenas’ complexity, resources, and structures this could be considered a methodological limitation. The fact that the micro-level data collection included only two out of the four regional health authorities in the Norwegian specialized healthcare system, may have hampered our knowledge about geographical variations. Lastly, the discussion is based on the reality as described by the participants in the interviews, as well as evidence found in documents, not as observed by the researchers. Thus, our synthesis does not fully explain why changes in clinical and managerial behaviour was lacking.