Table 1.

Conceptual Clarifications

The relationship of Quality, Safety and Resilience

• Different paradigms exist when it comes to resilience. This paper relies on a resilience engineering tradition that has been applied in healthcare [13]. • There is not always a clear distinction between the concepts of quality and safety in healthcare. • According to the Institute of Medicine, and the Norwegian adoption of the conceptualization of quality, quality consists of six dimensions: clinical effectiveness, patient safety, patient centeredness, care coordination, efficiency, timeliness, and equity [14, 15, 16, 17]. • Some definitions view safety as an “attribute of quality”, and successful healthcare outcomes as results from quality efforts [18]. According to Sheps & Cardiff [18] this view misses that tradeoffs, complexity and variability are important elements in healthcare. • In this paper, we argue that there are different quality dimensions with safety as one dimension. Resilience is about creating and obtaining high quality services (Safety-II). We thus apply a wider definition compared to traditional literature focusing on risk and safety (Safety-I). Our perspective is in line with the ongoing Resilience in Healthcare Research Program (2018–2023) [12]. • We define resilience as “the capacity to adapt to challenges and changes at different system levels, to maintain high quality care” [12].

Resilient Performance

• According to Hollnagel [19], any organization that manages to respond to, monitor, learn from and anticipate both expected and unexpected events would in a strict sense have potential for resilient performance. Performance, however, is complicated to study and to measure theoretically because it depends on context and local circumstances. • In this paper, the potential for resilient performance is explored as the potential to adapt regulatory requirements into daily work practices.

Regulation

• Legal and regulatory matters are primarily developed, applied and disputed within national borders. This makes legal terminology and regulatory activities multifaceted and not easy to interconnect on an international scale. • This paper defines the phenomenon of regulation generally and specifically: 1. as a general governmental mechanism/instrument (including inspection; supervision). 2. as one specific Norwegian regulatory framework; regime referred to in this paper as the Quality Improvement Regulation with a capital “R” in “regulation”. • In this paper a regulatory system of Internal Control is defined as enforced self-regulation characterized by the organization’s individual responsibility to apply systematic measures to ensure that all organizational activities are planned, organized, carried out and maintained in accordance with governmental requirements- and health legislation [20]. • We define performance-based regulation as a regulatory instrument that requires certain outcomes (achieved or avoided) without specifying any solutions [9].