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

## TL;DR

This study explores how external inspections in Norwegian hospitals handle serious incidents and whether stakeholder views are considered.

## Contribution

It introduces a qualitative mixed methods approach to analyze inspection practices and stakeholder involvement in healthcare regulation.

## Key findings

- External inspections are shifting toward more stakeholder involvement, but this is complex and challenging.
- Inspectors struggle to balance formal objectives with public and stakeholder expectations.
- Current inspection systems may not fully address the needs of hospitals, patients, and caregivers.

## Abstract

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.

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.

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.

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.

The online version contains supplementary material available at 10.1186/s12913-024-10714-9.