PMID- 26071401
OWN - NLM
STAT- MEDLINE
DCOM- 20160325
LR  - 20181113
IS  - 1748-717X (Electronic)
IS  - 1748-717X (Linking)
VI  - 10
DP  - 2015 Jun 13
TI  - Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to 
      CyberKnife Stereotactic Body Radiation Therapy (SBRT).
PG  - 132
LID - 10.1186/s13014-015-0438-0 [doi]
LID - 132
AB  - 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(R) 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.
FAU - Veronese, Ivan
AU  - Veronese I
AD  - Dipartimento di Fisica, Universita degli Studi di Milano, Via Celoria 16, Milan, 
      20133, Italy. ivan.veronese@unimi.it.
FAU - De Martin, Elena
AU  - De Martin E
AD  - Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, 
      Milan, Italy. Elena.DeMartin@istituto-besta.it.
FAU - Martinotti, Anna Stefania
AU  - Martinotti AS
AD  - Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. 
      AnnaStefania.Martinotti@cdi.it.
FAU - Fumagalli, Maria Luisa
AU  - Fumagalli ML
AD  - Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, 
      Milan, Italy. MariaLuisa.Fumagalli@istituto-besta.it.
FAU - Vite, Cristina
AU  - Vite C
AD  - Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. 
      Cristina.Vite@gmail.com.
AD  - Present address; Now at: Clinica Luganese, Lugano, Switzerland. 
      Cristina.Vite@gmail.com.
FAU - Redaelli, Irene
AU  - Redaelli I
AD  - Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. 
      irene.redaelli@gmail.com.
FAU - Malatesta, Tiziana
AU  - Malatesta T
AD  - Ospedale San Giovanni Calibita Fatebenefratelli, UOC Fisica Sanitaria AFAR, Rome, 
      Italy. tiziana.malatesta@tin.it.
FAU - Mancosu, Pietro
AU  - Mancosu P
AD  - Reparto di Radioterapia Oncologica, Istituto Clinico Humanitas, Milan, Italy. 
      pietro.mancosu@humanitas.it.
FAU - Beltramo, Giancarlo
AU  - Beltramo G
AD  - Centro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. 
      giancarlo.beltramo@cdi.it.
FAU - Fariselli, Laura
AU  - Fariselli L
AD  - Fondazione IRCCS Istituto Neurologico Carlo Besta Milano, Unita di Radioterapia, 
      Milan, Italy. laura.fariselli@istituto-besta.it.
FAU - Cantone, Marie Claire
AU  - Cantone MC
AD  - Dipartimento di Fisica, Universita degli Studi di Milano, Via Celoria 16, Milan, 
      20133, Italy. marie.cantone@unimi.it.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20150613
PL  - England
TA  - Radiat Oncol
JT  - Radiation oncology (London, England)
JID - 101265111
SB  - IM
MH  - *Healthcare Failure Mode and Effect Analysis
MH  - Humans
MH  - Italy
MH  - Liver Neoplasms/*surgery
MH  - Medical Errors
MH  - Patient Safety
MH  - Postoperative Complications/epidemiology/etiology
MH  - *Radiosurgery/adverse effects/instrumentation
MH  - Risk
MH  - Spinal Neoplasms/*surgery
MH  - Treatment Failure
PMC - PMC4469574
EDAT- 2015/06/14 06:00
MHDA- 2016/03/26 06:00
PMCR- 2015/06/13
CRDT- 2015/06/14 06:00
PHST- 2015/01/16 00:00 [received]
PHST- 2015/06/09 00:00 [accepted]
PHST- 2015/06/14 06:00 [entrez]
PHST- 2015/06/14 06:00 [pubmed]
PHST- 2016/03/26 06:00 [medline]
PHST- 2015/06/13 00:00 [pmc-release]
AID - 10.1186/s13014-015-0438-0 [pii]
AID - 438 [pii]
AID - 10.1186/s13014-015-0438-0 [doi]
PST - epublish
SO  - Radiat Oncol. 2015 Jun 13;10:132. doi: 10.1186/s13014-015-0438-0.