PS-066 Use of a risk analysis method in a chemotherapy production centralised unit

Abstract

BackgroundThe significant increase in the number of patients affected by cancer has provoked medical and pharmaceutical teams to improve the quality and safety of the chemotherapy process.PurposeThe objective was to analyse the production of chemotherapy treatments in an isolator after physician’s prescription, and pharmaceutical analysis of the prescription in our cytotoxic production centralised unit.Material and methodsThe preliminary hazard analysis (PHA) method was used. To lead this analysis, a multidisciplinary group was formed. The different steps of the PHA were to:-define the boundaries of the study, the scales of likelihood and severity, and the risk ranking table;-realise the cartography of hazardous situations (HS) and determine the priority’s level associated with the vulnerability of exposed elements (priority 1 for very vulnerable element and priority 2 for vulnerable element); -elaborate scenarios corresponding to HS and evaluate initial risk index;-propose preventive actions and evaluate final risk index.Data were analysed by the software Statcart.ResultsThe study of chemotherapy process revealed 5 phases: picking of drugs and medical devices, sterilisation, chemotherapy preparation in an isolator, packaging and dispensing. 129 HS: 43 HS of priority 1 and 86 HS of priority 2. Categories of hazards causing most HS were linked to management (29/129) and human factors (32/129). The phase ‘chemotherapy preparations in an isolator’ represented more than 55% (24/43) of priority 1 HS. From these 24 HS, 34 scenarios were developed: 44% (15/34) presented an acceptable risk (C1), 56% (19/34) presented a tolerable risk under control (C2) and none presented an inacceptable risk (C3). The 19 scenarios quoted in C2 needed preventive measures to reduce the risk. After implementation of these measures, all scenarios will present an acceptable risk.ConclusionThis PHA allowed us to highlight HS in our chemotherapy production process. Professional practice evaluations of pharmacy technicians and analytical controls of preparations are part of recommended preventive measures. A timetable for the implementation of measures is being drafted. To improve quality of the entire process, the other critical phases, such as administration, will be analysed. PHA is a method which can be used in cytotoxic production units to assess and optimise risk management.No conflict of interest

A comparative risk assessment of dialysis care processes in the home and hospital care contexts

“…The importance of adopting a structured risk assessment for enhancing care of patients is discussed in literature. Several methods for structuring the risk assessment process, are discussed, for example, the Healthcare Failure Mode and Effect Analysis (HFMEA) (McElroy et al 2016;Franklin et al 2012;Rosen et al 2015;Garfield et al 2018;De Giorgi et al 2010), Preliminary hazard analysis (PHA) (Schlatter 2018;Riou et al 2017;Grespan et al 2019Grespan et al , 2007De Giorgi et al 2010), and the Fault Tree Analysis (FTA) (McElroy et al 2017;Rogith et al 2017;Teixeira et al 2016;Ong and Coiera 2010). Nonetheless, owing to the uncertain nature of risks embedded in the clinical care pathways, applying specific risk assessment methods is not straightforward because of factors such as the need for patient records (for quantitative methods), domain knowledge, or user-knowledge on using different methods while assessing risks (Chemweno et al 2018;Beaussier et al 2016;Paine et al 2018).…”