title: Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT).
abstract: BACKGROUND
  A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres.
  
  
  METHODS
  The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered.
  
  
  RESULTS
  The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value.
  
  
  CONCLUSIONS
  The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.
authors.affiliation: Dipartimento di Fisica, Università degli Studi di Milano, Via Celoria 16, Milan, 20133, Italy. ivan.veronese@unimi.it.
authors.forename: Ivan
authors.initials: I
authors.lastname: Veronese
authors.affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, Milan, Italy. Elena.DeMartin@istituto-besta.it.
authors.forename: Elena
authors.initials: E
authors.lastname: De Martin
authors.affiliation: Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. AnnaStefania.Martinotti@cdi.it.
authors.forename: Anna Stefania
authors.initials: AS
authors.lastname: Martinotti
authors.affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, Milan, Italy. MariaLuisa.Fumagalli@istituto-besta.it.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Fumagalli
authors.affiliation: Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. Cristina.Vite@gmail.com.|Present address; Now at: Clinica Luganese, Lugano, Switzerland. Cristina.Vite@gmail.com.
authors.forename: Cristina
authors.initials: C
authors.lastname: Vite
authors.affiliation: Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. irene.redaelli@gmail.com.
authors.forename: Irene
authors.initials: I
authors.lastname: Redaelli
authors.affiliation: Ospedale San Giovanni Calibita Fatebenefratelli, UOC Fisica Sanitaria AFAR, Rome, Italy. tiziana.malatesta@tin.it.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Malatesta
authors.affiliation: Reparto di Radioterapia Oncologica, Istituto Clinico Humanitas, Milan, Italy. pietro.mancosu@humanitas.it.
authors.forename: Pietro
authors.initials: P
authors.lastname: Mancosu
authors.affiliation: Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. giancarlo.beltramo@cdi.it.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Beltramo
authors.affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, Unità di Radioterapia, Milan, Italy. laura.fariselli@istituto-besta.it.
authors.forename: Laura
authors.initials: L
authors.lastname: Fariselli
authors.affiliation: Dipartimento di Fisica, Università degli Studi di Milano, Via Celoria 16, Milan, 20133, Italy. marie.cantone@unimi.it.
authors.forename: Marie Claire
authors.initials: MC
authors.lastname: Cantone
mesh_terms: D000067495:Healthcare Failure Mode and Effect Analysis; D006801:Humans; D007558:Italy; D008113:Liver Neoplasms / Q000601:surgery*; D019300:Medical Errors; D061214:Patient Safety; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D016634:Radiosurgery / Q000009:adverse effects / Q000295:instrumentation; D012306:Risk; D013125:Spinal Neoplasms / Q000601:surgery*; D017211:Treatment Failure