Table 4 Contrasts in content of the previous and new regulatory framework

In contrast to the previous “Internal Control Regulations”, the new Quality Improvement Regulation:

• has a plan, do, study, act structure (the PDSA cycle) [30, 34, 36],

• adds management and quality improvement terminology, by explicitly addressing the top hospital management level as judicially responsible for systematic and continuous improvement of quality

• specifies delegation of quality improvement work related tasks, by stating that the practical- day to day- implementation is delegated to every management level in the relevant hospital

• adds an obligation to annually conduct a systematic evaluation of the organization’s risk management and quality improvement measures

The new Quality Improvement Regulation outlines a set of four main components in hospital risk management and implementation of measures set to improve quality:

• (P) the duty to plan,

• (D) the duty to implement,

• (S) the duty to evaluate,

• (A) the duty to correct

Each major improvement measure or risk reducing measure should:

• operationalize its specific goals, resources, and activities along with the four PDSA components

• consider its measures based on specific contextual conditions: resources, competences, and activities