A Contribution to Strength Safety Culture in the Radionuclide Therapy with Integrated Risk Analysis in Cuba

For the management of quality and safety in medicine with ionizing radiation and the continuous improvement of the processes, the performance of the risk analysis is required for the evaluation of safety of the practices in Cuba. There are different methodologies for risk analysis. The state-of-the-art shows risk matrix (RM), the analysis of failure modes and effects (FMEA) and the incident learning system (ILS) have a limited combined use and uncommon and without application in radionuclide therapy (RT). The objective of this work is to analyse radiological risks in RT in Cuba, by establishing synergy between prospective and reactive methods focused in root causes for patients, workers and public. To undertake this investigation the following procedure was followed: (a) Review and adaptation the developed risk matrix generic models and taking into account the publication TG-100 of AAPM for each case of study (the first five cases for conventional therapy and the six case for personalized treatment); (b) Selection of initiating events (IE) and defences (frequency reducers (FR), barriers (B) and consequences reducers (CR)), applicable to the practices that were carried out in Cuba at the moment of the investigation. These practices are radiosynoviorthesis (RSV) and the myelosupressor treatment of Polycythemia Vera (PV) with Phosphorous 32, the treatment of cancer and benign thyroid diseases and personalized treatment of thyroid illness. Determination by case in study of the inherent risk and the residual risk; (c) Identification of the main stages of process and defences, both due to their percentage participation and their impact on the level of risk when they are eliminated and determination of consequences of incidents behaviour for patients, workers and public. (d) Main sub-processes and root causes from FMEA are in correspondence with the values of the risk priority number (RPN) and severity (S), but on the basis of equivalence between RM and FMEA with the previously adaptation of FMEA scale for patients, workers and public. Also, a conversion of each defence in a root cause is applied by expert´s criteria and a deployment of these. The used selection criterions are RPN≥100 and ISev≥7 and the 20% of highest value of RPN. (e) Creation of an ILS with information from articles and published reports, mainly from Australia and the United States. This includes around 30 years of published events and near misses (for the last case it was used an adapted Nyflot´s five level scale), a wide standard list of root causes and adapted SAFRON´s severity scale. Realization of the FMEA-ILS synergies, to determine the most important sub- process by FMEA and the predominant basic causes. (f) Validation of the risk matrix generic model with RM-ILS, with the better matching between initiating events and records, determination of the most reported root causes in the ILS; (g) Use of the Cuban code SECURE MR-FMEA version 3.0, developed in the Higher Institute of Advanced Technologies and Sciences (INSTEC) and (h) Creation as a training tool of an informational compendium made with Macromedia Dreamweaver 8. (i) Recommendations of actions for strengthening of safety culture in an organization and recommendations to the Cuban regulatory bodies taking into account the ACCIRAD project ENER/D4/160-2011 and adapting these.