Regulatory rationale and governmental expectations for a new internal control regime in healthcare

Abstract

Background: According to Norwegian supervision bodies, there has been a lack of competence and compliance in relation to internal control regulation in healthcare. As a response, a new leadership-focused regulation for quality improvement was implemented across the Norway healthcare system, effective from January 1st 2017. Studies indicate a knowledge gap on quality and safety regulation related to resilience, thus there is a need to develop new knowledge about this relationship. The aim of this study is to explore the governmental foundations and expectations of the new internal control regulation and how it facilitates or hampers resilience in healthcare. The study applies resilience in healthcare and risk regulation as theoretical perspectives. The design is a single embedded case study, investigating the Norwegian regulatory regime in healthcare. Data was collected by approaching 3 regulatory bodies through formal letters, asking them to provide internal and public documents, and by Internet-based search through open sources to access available federal documents and reports. Based on this, a document analysis was conducted, supplemented by interviews with 7 strategic informants in the regulatory bodies. Preliminary results indicate that there is a common understanding throughout the national regulatory bodies of the rationale for adjusting the regulation: implementation issues, lack of leadership competencies and responsibilities and the control component did not sit well with the field of hospital practice. However, the expectations towards the regulation’s capability to facilitate resilient potential such as flexibility and adaptation to local context and improve hospital performance, seem to vary with the informants’ affiliation to the governmental institutions and/or educational background and position. Preliminary conclusion: There is a need for multilevel research and increased governmental competence on how to support implementation of a new leadership regulation as a foundation for resilient hospital performance.