Table 3 Theme 1 and 2, codes, and examples of document citations

THEME 1 Perspectives on different External Inspection Approaches of Responding and Involving stakeholders in External Inspection following Serious Incidents

Five key approaches of responding, used in incident-based inspection with intention to increase stakeholder involvement

“The County Governor must assess which procedures are the most appropriate to get the necessary progress in the (internal) improvement work, and what will be most expedient in each individual case. How extensive and close the follow-up should be depends on a specific assessment of the content of the case and the conditions in the (healthcare) organization”. NBHS guidelines to the County Governors ref. 12.06.2023 [60].

Frequent hospital application of self-assessment templates in inspections

“The (healthcare) organization is responsible for patient safety and quality improvement work. By application of this approach, we perform inspection of whether the organization’s follow-up processes are in accordance with the Quality Improvement Regulations”. NBHS guidelines to the County Governors ref. 12.06.2023 [60].

Infrequent on-site inspection in hospital settings

“When the NBHS receives a notification (…), it should conduct on-site inspection as soon as possible, if this is necessary in order to sufficiently inform the case”. The Health Supervision Act, § 6 [40].

“When the department conducts on-site inspection, we always offer a meeting involving the patient/user and/or informal caregivers. The final report from onsite inspection is always returned to the patient/user and/or informal caregivers”. NBHS Annual Report 2021 [39].

THEME 2 Inspectors’ Internal Work Practices Versus External Expectations

The objectives of formal inspection encountering patients’ and informal caregivers’ understanding and perception of quality and safety

“The purpose of the Act is to establish government inspection which contributes to strengthening the safety and quality of the healthcare services and the public’s trust in healthcare professionals and the healthcare services”. The Health Supervision Act, § 1 [40].

“The experiences of users and informal caregivers from encounters with the (healthcare) services are important information when the Norwegian Board of Health Supervision prioritizes the use of external inspection resources. The experiences contribute to our inspection becoming relevant and to improving the quality and safety of the services. Involvement of users and informal caregivers is an important contribution to strengthening the public trust in the services”. NBHS Annual Report 2021 [39].

Sound professional practice principles encountering patients’ and informal caregivers’ understanding and perception of quality and safety

“Healthcare services offered or given in accordance with this Act should be (in line with the principle of) sound professional practice”. MHCS, 1999; the Specialized Healthcare Services Act, § 2–2 [41].

“Those who request the external inspection authority’s assessment of an incident may often have an expectation that we should conclude whether the health care provided was sound; adequate. The individual’s wishes for supervisory follow-up will in some cases conflict with the need we have to direct our efforts towards conditions that will lead to increased quality and safety for more people (than the individual). This must be clearly communicated, and we must explain why we prioritize the way we do. At the same time, we need to take care of the person who approached us”. NBHS guidelines to the County Governors ref. 12.12.2022 [62].

Governmental delegation of responsibility for incident-based inspection; Resource demands

“The County Governor is given the authority to supervise the healthcare services and is directly subordinate to the Norwegian Board of Health Supervision”. The Health Supervision Act, § 3 [3, 40].

“If the early case proceedings indicate that the case should be transferred to the County Governor for further process, we leave the County Governor with the overall contact with the patient/user/informal caregiver(s)”. NBHS Annual Report 2021 [39].