Quality and safety management of advanced medical technologies in home care organisations: A qualitative survey along the road to uniformity in the Netherlands.

Abstract Background: A Quality Management System (QMS) in health care organisations encompasses not only policies, processes and necessary procedures, but should also encompass quality, safety, and risk management of medical technology (MT). Tactical and operational decision-making levels should be closely interconnected. Previous studies showed that nurses at the operational level do have a good awareness of patient safety, but especially in teams with a strong degree of self-organisation the interaction with tactical levels is an issue. Methods: A qualitative methodology was employed to explores the perspectives of employees who are responsible at a tactical level in homecare organisations concerning the quality and safety of advanced medical technologies (AMTs). Fifteen semi-structured interviews were conducted with purposively sampled employees across the Netherlands. Data were analyzed thematically using mainly a deductive approach. Results: All organisations possess a QMS, with only seven participants indicating that there is a plan for the quality and safety of AMTs. Most organisations apply the national protocols in the use of AMTs and rely on the supplier’s maintenance protocols. Although some participants say that their organisation has no formal procedure for resolving malfunctions with AMTs, all know pathways to solve problems. Organisations use tailored training programs for nurses in using AMTs, but not all are testing knowledge and skills and/or demand the formal registration of competence of nurses. Professionals report an incident on a separate form in the electronic client file or via a separate reporting system. However, there is no uniformity within organisations about handling incidents. Most interviewees state that in any case, incidents are discussed in the team. On the dimension ‘reporting, evaluating and learning from incidents’, the prevalent patient safety culture is ‘proactive’ on average. Conclusions: There is a lack of uniformity regarding quality and safety procedures for the use of AMTs in homecare organisations and structured policies for the implementation, use and maintenance are needed. This study identified additional risk factors regarding individual competencies in the use of AMTs at home. Employees at a tactical level, seem to be more positive about the patient safety culture with AMTs in their organisations than nurses at operational level.