- 作者：Marta Scorsetti ; Chiara Signori ; Paola Lattuada ; Gaetano Urso ; Mario Bignardi ; Pierina Navarria ; Simona Castiglioni ; Pietro Mancosu ; Paolo Trucco
- 关键词：Risk analysis ; Process analysis ; FMECA ; Lessons learned
- 刊名：Radiotherapy and Oncology
- 出版年：2010
- 出版时间：March 2010
- 年：2010
- 卷：94
- 期：3
- 页码：367-374
- 全文大小：438 K
IntroductionThe radiation oncology process along with its unique therapeutic properties is also potentially dangerous for the patient, and thus it should be delivered under a systematic risk control. To this aim incident reporting and analysis are not sufficient for assuring patient safety and proactive risk assessment should also be implemented. The paper accounts for some methodological solutions, lessons learned and opportunities for improvement, starting from the systematic application of the failure mode effects and criticality analysis (FMECA) technique to the radiotherapy process of an Italian hospital.Materials and methods
The analysis, performed by a working group made of experts of the radiotherapy unit, was organised into the following steps: (1) complete and detailed analysis of the process (integration definition for function modelling); (2) identification of possible failure modes (FM) of the process, representing sources of adverse events for the patient; (3) qualitative risk assessment of FMs, aimed at identifying priorities of intervention; (4) identification and planning of corrective actions.
Results
Organisational and procedural corrective measures were implemented; a set of safety indexes for the process was integrated within the traditional quality assurance indicators measured by the unit. A strong commitment of all the professionals involved was observed and the study revealed to be a powerful “tool” for dissemination of patient safety culture.
Conclusion
The feasibility of FMECA in fostering radiotherapy safety was proven; nevertheless, some lessons learned as well as weaknesses of current practices in risk management open to future research for the integration of retrospective methods (e.g. incident reporting or root cause analysis) and risk assessment.