Estudo e desenvolvimento de um modelo de análise de risco para Radiocirurgia intracraniana

Abstract

The reported events in radiotherapy that constitute accidents or incidents have increased worldwide in the last 25 years. Most of these events resulted from human failure and have happened in radiotherapy centers that use high technologies. The radiotherapy Quality Management needs a prospective approach through risk analysis. This approach is supported by recent publications as this actually extremely needed due the large number of accidents. Because of the complexity of the process in radiotherapy, the search for quality of care in order to ensure patient safety is one of the most discussed topics worldwide. Although only 14% of radiotherapy centers in Brazil offer treatments with intracranial radiosurgery technique (SRS), studies about the quality of care related to the safety of patients undergoing this technique is of great importance. Any deviations from the prescribed dose using SRS technique is considered more critical than in other methods of radiation treatment, as the delivered doses in SRS are higher, in the range of 10 Gy to 40 Gy, to lesions up to 50 mm in diameter, which are delivered in a single fraction or in five fractions. In view of those information, this work aims to satisfy the new Quality Management paradigm by developing a risk analysis model, and a Quality Index for SRS in Brazil, through the techniques of Process Map and FMEA used in the TG100/AAPM. The study was performed in three high technology reference radiotherapy centers, two located in Rio de Janeiro city and one in Sao Paulo city. A SRS Process Map was identified for each radiotherapy center, and then FMEA technique was applied in every subprocesses identified on the map. From NPR values obtained by the FMEA a ranking of failure modes was held. Failure modes with NPR ≥ 100 and S ≥ 7 were chosen as priority to implement safety strategies. From the scores assigned to the S parameter in the implementation of FMEA a Severity Index (SI) and a Quality Index (QI) were created from an association between the NPR and the SI. The result of this study indicates that safety strategies should be implemented for the first 10 failure modes of the ranking, and a new evaluation of the process should occur every year. In addition, it is also indicated that the QI shows a minimum improvement of 9 % after the re-evaluation of the process. Overall, the study showed that the adoption of the FMEA tool together with the QI are justified as they minimize the risks to the patient, improving the quality of care and enhancing the safety Taken together the FMEA and the QI create mechanisms for ensuring that the dose will be delivered more precisely and accurately, and consequently, this increases the chances of cure or local control of the tumor, improving quality of life of the patients.