Patient safety in the interface between hospital and risk regulator1

The paper explores how regulatory practice affects procedures and routines regarding patient safety in hospitals. The paper is based on a multi-level case study within the Norwegian healthcare system. In this paper we investigate methods of operations between the risk regulator and the regulatee by emphasizing systematic and incidental activities performed in the interface; and by assessing the regulators' underlying models of understanding errors. Our study indicates that despite a strong commitment from the top management and increased awareness and efforts within the hospital, methods of operation between risk regulator and hospital do not have a substantial impact on patient safety improvement and learning from errors within the hospital. The study shows that patient safety is exposed to pressures from internal mechanisms (e.g. occupational subcultures, regulatory styles, underreporting) and external mechanisms (e.g. public attitudes, organized interests, media cover) with consequences that have to be managed across organizational interfaces. Thus, understanding of vertical risk governance processes and the involved organizational interfaces is vital.