Application Of Risk Analysis Methods To Stereotactic Body Radiation Therapy(SBRT)Quality Management

Objective:The aim of this work was application of the risk analysis approach to assess the risks for patients undergoing the Stereotactic Body Radiation Therapy and to design and improve the quality control methods to ensure the safety and quality of SBRT.Methods:A Multidisciplinary team was formed to conduct the risk analysis method of SBRT with four steps:1)identification of the whole SBRT process;2)identification of the failure modes(FM)and the causes of them of the whole process,ranking the FMs by risk priority number(RPN)together with failure mode and effect analysis(FMEA)and the scoring system;3)identification of the high risks FMs and performing fault tree analysis;4)designing and improving the quality control methods.At last to investigate the effectiveness of the quality control methods through performing FMEA once again for some high risks FMs.Results:the SBRT procedure consists of 14 main processes,70 sub-processes;228 total failure modes were identified,RPN ranking from 21 to 202.5,the high risk FM threshold was set to 148,45 high FMs were identified.Top 5 FMs(RPN)were Prior medical records with wrong review(202.5),active breathing control with wrong guidance(194.5),CBCT registration error(189),contouring error(187.5),couch removing error(187.2).Scores of 0 D of the second FMEA were found to be lower than the first time after the quality control methods was performed.The whole method conducted was last 5 months with 8 departments and 36 members participated in.Conclusion:risk analysis is a simple and practical as well as an effective method for systematic analysis in SBRT to design and improve quality management to ensure the safety and quality of SBRT.