External inspection approaches and involvement of stakeholders' views in inspection following serious incidents - a qualitative mixed methods study from the perspectives of regulatory inspectors.

OBJECTIVE: The objective was to gain knowledge about how external inspections following serious incidents are played out in a Norwegian hospital context from the perspective of the inspectors, and whether stakeholders' views are involved in the inspection. METHODS: Based on a qualitative mixed methods design, 10 government bureaucrats and inspectors situated at the National Board of Health Supervision and three County Governors in Norway, were strategically recruited, and individual semi-structured interviews were conducted. Key official government documents were selected, collected, and thematically analyzed along with the interview data. RESULTS: Our findings overall demonstrate two overarching themes: Theme (1) Perspectives on different external inspection approaches of responding and involving stakeholders in external inspection following serious incidents, Theme (2) Inspectors' internal work practices versus external expectations. Documents and all participants reported a development towards new approaches in external inspection, with more policies and regulatory attention to sensible involvement of stakeholders. Involvement and interaction with patients and informal caregivers could potentially inform the case complexity and the inspector's decision-making process. However, stakeholder involvement was sometimes complex and challenging due to e.g., difficult communication and interaction with patients and/or informal caregivers, due to resource demands and/or the inspector's lack of experience and/or relevant competence, different perceptions of the principle of sound professional practice, quality, and safety. The inspectors considered balancing the formal objectives and expectations, with the expectations of the public and different stakeholders (i.e. hospitals, patients and/or informal caregivers) a challenging part of their job. This balance was seen as an important part of the continuous development of ensuring public trust and legitimacy in external inspection processes. CONCLUSIONS AND IMPLICATIONS: Our study suggests that the regulatory system of external inspection and its available approaches of responding to a serious incident in the Norwegian setting is currently not designed to accommodate the complexity of needs from stakeholders at the levels of hospital organizations, patients, and informal caregivers altogether. Further studies should direct attention to how the wider system of accountability structures may support the internal work practices in the regulatory system, to better algin its formal objectives with expectations of the public.

Linking resilience and regulation across system levels in healthcare - a multilevel study.

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.

Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study.

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.

Influence of external assessment on quality and safety in surgery: a qualitative study of surgeons' perspectives.

INTRODUCTION: Transparency about the occurrence of adverse events has been a decades-long governmental priority, defining external feedback to healthcare providers as a key measure to improve the services and reduce the number of adverse events. This study aimed to explore surgeons' experiences of assessment by external bodies, with a focus on its impact on transparency, reporting and learning from serious adverse events. External bodies were defined as external inspection, police internal investigation, systems of patient injury compensation and media. METHODS: Based on a qualitative study design, 15 surgeons were recruited from four Norwegian university hospitals and examined with individual semi-structured interviews. Data were analysed by deductive content analysis. RESULTS: Four overarching themes were identified, related to influence of external inspection, police investigation, patient injury compensation and media publicity, (re)presented by three categories: (1) sense of criminalisation and reinforcement of guilt, being treated as suspects, (2) lack of knowledge and competence among external bodies causing and reinforcing a sense of clashing cultures between the 'medical and the outside world' with minor influence on quality improvement and (3) involving external bodies could stimulate awareness about internal issues of quality and safety, depending on relevant competence, knowledge and communication skills. CONCLUSIONS AND IMPLICATIONS: This study found that external assessment might generate criminalisation and scapegoating, reinforcing the sense of having medical perspectives on one hand and external regulatory perspectives on the other, which might hinder efforts to improve quality and safety. External bodies could, however, inspire useful adjustment of internal routines and procedures. The study implies that the variety and interconnections between external bodies may expose the surgeons to challenging pressure. Further studies are required to investigate these challenges to quality and safety in surgery.

Naming the "baby" or the "beast"? The importance of concepts and labels in healthcare safety investigation.

This paper focuses on concepts and labels used in investigation of adverse events in healthcare. The aim is to prompt critical reflection of how different stakeholders frame investigative activity in healthcare and to discuss the implications of the labels we use. We particularly draw attention to issues of investigative content, legal aspects, as well as possible barriers and facilitators to willingly participate, share knowledge, and achieve systemic learning. Our message about investigation concepts and labels is that they matter and influence the quality of investigation, and how these activities may contribute to system learning and change. This message is important for the research community, policy makers, healthcare practitioners, patients, and user representatives.

Learning from experience: a qualitative study of surgeons' perspectives on reporting and dealing with serious adverse events.

INTRODUCTION: In 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. METHODS: Based 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 DISCUSSION: We 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 IMPLICATIONS: This 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.

Articulating Concepts Matters! Resilient Actions in the Norwegian Governmental Response to the COVID-19 Pandemic Comment on "Government Actions and Their Relation to Resilience in Healthcare During the COVID-19 Pandemic in New South Wales, Australia and Ontario, Canada".

The coronavirus disease 2019 (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.

Investigating Hospital Supervision: A Case Study of Regulatory Inspectors' Roles as Potential Co-creators of Resilience.

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.

Hospital managers' perspectives with implementing quality improvement measures and a new regulatory framework: a qualitative case study.

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. DESIGN: This 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. SETTING: Three hospitals retrieved from two regional health trusts in Norway. PARTICIPANTS: 20 hospital managers or quality advisers selected from different levels of hospital organisations. RESULTS: Four 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). CONCLUSIONS: This 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.