Objectives The aim of this study was to explore if, and in what ways, there has been changes in the supervisory approach toward Norwegian hospitals due to the implementation of a new management and quality improvement regulation (Regulation on Management and Quality Improvement in the Healthcare Services, hereinafter referred to as “Quality Improvement Regulation”). Moreover, we aimed to understand how inspectors’ work promotes or hampers resilience potentials of adaptive capacity and learning in hospitals. Methods The study design is a case study of implementation and impact of the Quality Improvement Regulation. We performed a document analysis, and conducted and analyzed 3 focus groups and 2 individual interviews with regulatory inspectors, recruited from 3 county governor offices who are responsible for implementation and supervision of the Quality Improvement Regulation in Norwegian regions. Results Data analysis resulted in 5 themes. Informants described no substantial change in their approach owing to the Quality Improvement Regulation. Regardless, data pointed to a development in their practices and expectations. Although the Norwegian Board of Health Supervision, at the national level, occasionally provides guidance, supervision is adapted to specific contexts and inspectors balance trade-offs. Informants expressed concern about the impact of supervision on hospital performance. Benefits and disadvantage with positive feedback from inspectors were debated. Inspectors could nurture learning by improving their follow-up and add more hospital self-assessment. Conclusions A nondetailed regulatory framework such as the Quality Improvement Regulation provides hospitals with room to maneuver, and self-assessment might reduce resource demands. The impact of supervision is scarce with an unfulfilled potential to learn from supervision. The Government could contribute to a shift in focus by instructing the county governors to actively reflect on and communicate positive experiences from, and smart adaptations in, hospital practice.

Background: The relationship between quality and safety regulation and resilience in healthcare has received little systematic scrutiny. Accordingly, this study examines the introduction of a new regulatory framework (the Quality Improvement Regulation) in Norway that aimed to focus on developing the capacity of hospitals to continually improve quality and safety. The overall aim of the study was to explore the governmental rationale and expectations in relation to the Quality Improvement Regulation, and how it could potentially influence the management of resilience in hospitals. The study applies resilience in healthcare and risk regulation as theoretical perspectives. Methods: The design is a single embedded case study, investigating the Norwegian regulatory healthcare regime. Data was collected by approaching three regulatory bodies through formal letters, asking them to provide internal and public documents, and by searching through open Internet-sources. Based on this, we conducted a document analysis, supplemented by interviews with seven strategic informants in the regulatory bodies. Results: The rationale for introducing the Quality Improvement Regulation focused on challenges associated with implementation, lack of management competencies; need to promote quality improvement as a managerial responsibility. Some informants worried that the generic regulatory design made it less helpful for managers and clinicians, others claimed a non-detailed regulation was key to make it fit all hospital-contexts. The Government expected hospital managers to obtain an overview of risks and to adapt risk management and quality improvement measures to their specific context and activities. Conclusions: Based on the rationale of making the Quality Improvement Regulation flexible to hospital context, encouraging the ability to anticipate local risks, along with expectations about the generic design as challenging for managers and clinicians, we found that the regulators did consider work as done as important when designing the Quality Improvement Regulation. These perspectives are in line with ideas of resilience. However, the Quality Improvement Regulation might be open for adaptation by the regulatees, but this may not necessarily mean that it promotes or encourages adaptive behavior in actual practice. Limited involvement of clinicians in the regulatory development process and a lack of reflexive spaces might hamper quality improvement efforts.

A new regulatory framework to support local quality and safety efforts in hospitals was introduced to the Norwegian healthcare system in 2017. This study aimed to investigate hospital managers’ perspectives on implementation efforts and the resulting work practices, to understand if, and how, the new Quality Improvement Regulation influenced quality and safety improvement activities.DesignThis article reports one study level (the perspectives of hospital managers), as part of a multilevel case study. Data were collected by interviews and analysed according to qualitative content analysis.SettingThree hospitals retrieved from two regional health trusts in Norway.Participants20 hospital managers or quality advisers selected from different levels of hospital organisations.ResultsFour themes were identified in response to the study aim: (1) adaptive capacity in hospital management and practice, (2) implementation efforts and challenges with quality improvement, (3) systemic changes and (4) the potential to learn. Recent structural and cultural changes to, and development of, quality improvement systems in hospitals were discovered (3). Participants however, revealed no change in their practice solely due to the new Quality Improvement Regulation (2). Findings indicated that hospital managers are legally responsible for quality improvement implementation and participants described several benefits with the new Quality Improvement Regulation (2). This related to adaptation and flexibility to local context, and clinical autonomy as an inevitable element in hospital practice (1). Trust and a safe work environment were described as key factors to achieve adverse event reporting and support learning processes (4).ConclusionsThis study suggests that a lack of time, competence and/or motivation, impacted hospitals’ implementation of quality improvement efforts. Hospital managers’ autonomy and adaptive capacity to tailor quality improvement efforts were key for the new Quality Improvement Regulation to have any relevant impact on hospital practice and for it to influence quality and safety improvement activities.

Background The Quality Improvement Regulation was introduced to the Norwegian healthcare system in 2017 as a new national regulatory framework to support local quality and safety efforts in hospitals. A research-based response to this, was to develop a study with the overall research question: How does a new healthcare regulation implemented across three system levels contribute to adaptive capacity in hospital management of quality and safety? Based on development and implementation of the Quality Improvement Regulation, this study aims to synthesize findings across macro, meso, and micro-levels in the Norwegian healthcare system. Methods The multilevel embedded case study collected data by documents and interviews. A synthesizing approach to findings across subunits was applied in legal dogmatic and qualitative content analysis. Setting: three governmental macro-level bodies, three meso-level County Governors and three micro-level hospitals. Participants: seven macro-level regulators, 12 meso-level chief county medical officers/inspectors and 20 micro-level hospital managers/quality advisers. Results Based on a multilevel investigation, three themes were discovered. All system levels considered the Quality Improvement Regulation to facilitate adaptive capacity and recognized contextual flexibility as an important regulatory feature. Participants agreed on uncertainty and variation to hamper the ability to plan and anticipate risk. However, findings identified conflicting views amongst inspectors and hospital managers about their collaboration, with different perceptions of the impact of external inspection. The study found no changes in management- or clinical practices, nor substantial change in the external inspection approach due to the new regulatory framework. Conclusions The Quality Improvement Regulation facilitates adaptive capacity, contradicting the assumption that regulation and resilience are “hopeless opposites”. However, governmental expectations to implementation and external inspection were not fully linked with changes in hospital management. Thus, the study identified a missing link in the current regime. We suggest that macro, meso and micro-levels should be considered collaborative partners in obtaining system-wide adaptive capacity, to ensure efficient risk regulation in quality improvement and patient safety processes. Further studies on regulatory processes could explore how hospital management and implementation are influenced by regulators’, inspectors’, and managers’ professional backgrounds, positions, and daily trade-offs to adapt to changes and maintain high quality care.

The COVID-19 pandemic has challenged our healthcare systems and required collaboration from both centralized and decentralized system levels to adapt to the changes and challenges. This commentary offers a look into the Norwegian governmental healthcare system and response within a resilience in healthcare perspective, by analyzing the situated, structural, and systemic resilience. Such a conceptualization of resilience into three scales of organizational activity may assist our efforts to understand and explain governmental actions throughout the pandemic. Research application of resilience in healthcare to explain and discuss government actions during the COVID-19 pandemic, needs to ensure sensitivity to the overall structural, cultural, and human factor aspects of the relevant healthcare system under scrutiny as well as sensitivity to specific context within the various system levels.

IntroductionIn surgery, serious adverse events have effects on the patient journey, the patient outcome and may constitute a burden to the surgeon involved. This study aims to investigate facilitators and barriers to transparency around, reporting of and learning from serious adverse events among surgeons.MethodsBased on a qualitative study design, we recruited 15 surgeons (4 females and 11 males) with 4 different surgical subspecialties from four Norwegian university hospitals. The participants underwent individual semistructured interviews and data were analysed according to principles of inductive qualitative content analysis.Results and discussionWe identified four overarching themes. All surgeons reported having experienced serious adverse events, describing these as part of ‘the nature of surgery’. Most surgeons reported that established strategies failed to combine facilitation of learning with taking care of the involved surgeons. Transparency about serious adverse events was by some felt as an extra burden, fearing that openness on technical-related errors could affect their future career negatively. Positive implications of transparency were linked with factors such as minimising the surgeon’s feeling of personal burden with positive impact on individual and collective learning. A lack of facilitation of individual and structural transparency factors could entail ‘collateral damage’. Our participants suggested that both the younger generation of surgeons in general, and the increasing number of women in surgical professions, might contribute to ‘maturing’ the culture of transparency.Conclusion and implicationsThis study suggests that transparency associated with serious adverse events is hampered by concerns at both personal and professional levels among surgeons. These results emphasise the importance of improved systemic learning and the need for structural changes; it is crucial to increase the focus on education and training curriculums and offer advice on coping strategies and establish arenas for safe discussions after serious adverse events.

Introduction: A new regulatory framework (the Quality Improvement Regulation) to support local, management-based quality and safety efforts in hospitals was introduced to the Norwegian healthcare system in 2017. This thesis explores healthcare regulation and resilience through the Quality Improvement Regulation, by investigating its possible links to adaptive capacity in hospital management of quality and safety enhancing activities. The literature lacks studies exploring how regulation and resilience intertwine, two concepts often considered as counterparts. Hence, there is a gap in knowledge about regulatory and supervisory impact on quality and safety, and attention to hospital managers’ competences and responsibilities as key elements to resilience in healthcare. This thesis therefore casts a new light on how regulators and inspectors may design, inspect, and enforce a regulation regime, and thereby contribute to adaptive capacity, anticipatory capacity, and learning as key elements in different hospital contexts. Overall outputs from this thesis are important to the development and implementation of future regulatory amendments. Aim: The overall aim of this thesis was to explore the rationale, expectations, implementation, and management of the Quality Improvement Regulation. The overall and leading research question was: How does a new healthcare regulation implemented across three system levels contribute to adaptive capacity in hospital management of quality and safety? Methods: The study was designed as a multilevel, single embedded case study. Data was collected by approximately 500 pages of documentary evidence, 29 individual interviews and 3 focus group interviews (10 participants): in total 39 participants. Data was analyzed by legal dogmatic and qualitative content analysis. Three levels of stakeholders were included from the Norwegian healthcare system: macro-level (three governmental regulatory bodies), meso- level (three County Governors), micro-level (three hospitals retrieved from two regional health authorities). Macro-level participants were seven strategic participants positioned at the Norwegian Ministry of Health and Care Services, the Norwegian Directorate of Health, and the Norwegian Board of Health Supervision. Meso-level participants were two chief county medical officers, three assistant chief county medical officers, and seven inspectors, recruited from three County Governors. Micro-level participants were 20 hospital managers or quality advisors selected from different levels at three hospitals. Findings: Paper I (macro-level) explored the governmental rationale for developing the Quality Improvement Regulation, expectations towards hospital management and its expected influence on resilience. Data retrieved from documentary evidence and individual interviews indicated that the rationale for the Quality Improvement Regulation’s design was to make it flexible to various hospital contexts. In turn, the macro-level expected hospital managers to anticipate local risks. However, the study found that the Government expected the generic regulatory design to come across as challenging for hospital managers and clinicians. Paper II (meso-level) investigated into changes in the supervisory approach and inspectors’ work to promote or hamper adaptive capacity and learning in hospitals. Evidence emerged from documents and focus group interviews and indicated that despite supervision being adapted to specific hospital contexts and the inspectors’ trade-offs, there was a general concern about the lack of impact of supervision on hospital performance. Paper III (micro-level) explored hospital managers’ perspectives on implementation efforts and the following work practices, to understand if, and how, the new Quality Improvement Regulation influenced quality and safety improvement activities. Across interview data, participants experienced the Quality Improvement Regulation as more suitable to variation and different contexts compared to the previous regulatory framework. However, findings revealed no change in practice related to quality and safety activities, solely due to the new regulatory framework, despite recent structural and cultural changes to quality improvement systems in hospitals. Data reported that lack of time, competence and/or motivation affected hospital implementation. Conclusions: This thesis represents a rare glimpse into regulatory implementation efforts across three system levels, set out in a resilience in healthcare perspective. This thesis revealed that regulators considered the perspective of variation, complexity, and uncertainty in hospital settings to be important when designing the Quality Improvement Regulation. The latter resonates with resilience in healthcare concepts and contradicts previous research. The Quality Improvement Regulation contributed to context adaptation, by supporting nondetailed risk based organizing and management of quality and safety. However, hospital managers’ autonomy and adaptive capacity to tailor quality improvement efforts were imperative for the regulatory requirements to have any relevant impact on hospital practice. Limited involvement of clinicians in the regulatory development process could hamper quality improvement efforts. Inspectors could nurture learning by improving their follow up, use expert inspectors, and add more hospital self- assessment activities. This thesis highlights the importance of ensuring that any macro-level quality improvement initiatives and regulatory requirements are accompanied by appropriate resourcing, support, and advanced preparation to ensure the best possible chance of getting implemented effectively.

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