Incident investigations by the regulatory authority of Swedish healthcare – a 20-year perspective

Abstract

Objective: The purpose of this study was to describe procedural changes in hospital incident investigations and show the consequences of these changes over time.
Methods: A two-stage method was used. First component of the study was a content analysis of 87 incident investigation sconducted 1995-2014 by the regulatory authority after adverse events in a Swedish university hospital. Second component was conducting semi-structured interviews with 11 investigators from all regulatory authority regional offices in Sweden.
Results: In a minority of incident investigations, where further demands for action were required by the regulatory authority, a major portion of these were aimed at the micro-level. A plan for follow-up was expressed in only one tenth of the investigations. All investigators had a background from the healthcare system and saw this as advantageous. Their personal memory was claimed to be the only tool when referring to previous cases. Less fieldwork, more office work and more uniformity of language were recognised changes in comparison over time. The role of doing “auditing” was the most common description by the investigators themselves.
Conclusions: The micro-level focus of the investigations reflected an organisational structure within the regulatory authority. We saw signs of parallel system weaknesses within the Swedish healthcare system with a clear absence of formalised organisational memory and a malfunctioning follow-up system of incident investigations. This can be seen both regarding the healthcare providers and the regulatory authority. The reports from the qualitative interviews data indicated that “auditing at the office” was considered the main occupation in incident investigations conducted by the regulatory authority.