Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability.

BACKGROUND AND PURPOSE Industrial companies use failure mode and effect analysis (FMEA) to improve quality. Our objective was to describe an FMEA and subsequent interventions for an automated intraoperative electron radiotherapy (IOERT) procedure with computed tomography simulation, pre-planning, and a fixed conventional linear accelerator. MATERIAL AND METHODS A process map, an FMEA, and a fault tree analysis are reported. The equipment considered was the radiance treatment planning system (TPS), the Elekta Precise linac, and TN-502RDM-H metal-oxide-semiconductor-field-effect transistor in vivo dosimeters. Computerized order-entry and treatment-automation were also analyzed. RESULTS Fifty-seven potential modes and effects were identified and classified into 'treatment cancellation' and 'delivering an unintended dose'. They were graded from 'inconvenience' or 'suboptimal treatment' to 'total cancellation' or 'potentially wrong' or 'very wrong administered dose', although these latter effects were never experienced. Risk priority numbers (RPNs) ranged from 3 to 324 and totaled 4804. After interventions such as double checking, interlocking, automation, and structural changes the final total RPN was reduced to 1320. CONCLUSIONS FMEA is crucial for prioritizing risk-reduction interventions. In a semi-surgical procedure like IOERT double checking has the potential to reduce risk and improve quality. Interlocks and automation should also be implemented to increase the safety of the procedure.

[1]  Eric C Ford,et al.  Evaluation of safety in a radiation oncology setting using failure mode and effects analysis. , 2009, International journal of radiation oncology, biology, physics.

[2]  Bruce Thomadsen.  Quality and safety in radiotherapy : learning the new approaches in task group 100 and beyond , 2013 .

[3]  Paul Keall,et al.  Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems. , 2010, Medical physics.

[4]  J Pascau,et al.  Feasibility of integrating a multi-camera optical tracking system in intra-operative electron radiation therapy scenarios , 2013, Physics in medicine and biology.

[5]  Juan A. Santos,et al.  Intraoperative radiation therapy opportunities for clinical practice normalization: Data recording and innovative development. , 2014, Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology.

[6]  B. Daniel,et al.  Defining an optimal role for breast magnetic resonance imaging when evaluating patients otherwise eligible for accelerated partial breast irradiation. , 2013, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[7]  Michael R. Beauregard,et al.  The Basics of FMEA , 1996 .

[8]  Roberto Orecchia,et al.  Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy , 2013, Radiation Oncology.

[9]  Giuseppe Iaccarino,et al.  In vivo dosimetry with MOSFETs: dosimetric characterization and first clinical results in intraoperative radiotherapy. , 2005, International journal of radiation oncology, biology, physics.

[10]  F. Calvo,et al.  Post-chemoradiation intraoperative electron-beam radiation therapy boost in resected locally advanced rectal cancer: long-term results focused on topographic pattern of locoregional relapse. , 2014, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[11]  Albert I. Wertheimer.  Medication error prevention , 2014 .

[12]  Maria Y Y Law,et al.  Informatics in radiology: DICOM-RT and its utilization in radiation therapy. , 2009, Radiographics : a review publication of the Radiological Society of North America, Inc.

[13]  Sara Broggi,et al.  Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy , 2013, Journal of applied clinical medical physics.

[14]  C. Madu.  Introduction to quality , 1998 .

[15]  R. Orecchia,et al.  Application of failure mode and effects analysis to intraoperative radiation therapy using mobile electron linear accelerators. , 2012, International journal of radiation oncology, biology, physics.

[16]  M. Valdivieso,et al.  Intraoperative Imaging in IOERT Sarcoma Treatment: Initial Experience in two Clinical Cases , 2011 .

[17]  Julian R Perks,et al.  Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy. , 2012, International journal of radiation oncology, biology, physics.

[18]  R. Corvò,et al.  On-line optimization of intraoperative electron beam radiotherapy of the breast. , 2012, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[19]  Claudio V. Sole,et al.  ISIORT pooled analysis 2013 update: clinical and technical characteristics of intraoperative radiotherapy , 2014 .

[20]  A. Luini,et al.  Real-time in vivo dosimetry using micro-MOSFET detectors during intraoperative electron beam radiation therapy in early-stage breast cancer. , 2006, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[21]  H. Bartelink,et al.  Has partial breast irradiation by IORT or brachytherapy been prematurely introduced into the clinic? , 2012, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[22]  G. Starkschall,et al.  American Association of Physicists in Medicine Radiation Therapy Committee Task Group 53: quality assurance for clinical radiotherapy treatment planning. , 1998, Medical physics.

[23]  J. Pascau,et al.  Research opportunities in intraoperative radiation therapy: the next decade 2013–2023 , 2013, Clinical and Translational Oncology.

[24]  Sasa Mutic,et al.  Process-based quality management for clinical implementation of adaptive radiotherapy. , 2014, Medical physics.

[25]  J. López-Tarjuelo,et al.  In vivo dosimetry in intraoperative electron radiotherapy , 2014, Strahlentherapie und Onkologie.

[26]  K. Popper,et al.  The critical attitude in medicine: the need for a new ethics. , 1983, British medical journal.

[27]  J. Tey,et al.  Adjuvant chemoradiotherapy with or without intraoperative radiotherapy for the treatment of resectable locally advanced gastric adenocarcinoma. , 2012, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[28]  Andrés Santos,et al.  Feasibility assessment of the interactive use of a Monte Carlo algorithm in treatment planning for intraoperative electron radiation therapy , 2014, Physics in medicine and biology.

[29]  A. Kuten,et al.  Clinical and technical characteristics of intraoperative radiotherapy , 2013, Strahlentherapie und Onkologie.

[30]  F. Vicini,et al.  Cardiac dose sparing and avoidance techniques in breast cancer radiotherapy. , 2014, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[31]  Todd Pawlicki,et al.  Quality and Safety in Radiotherapy , 2010 .

[32]  L. Potters,et al.  Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine , 2013, Front. Oncol..

[33]  Roberto Orecchia,et al.  IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: long term results of an ISIORT pooled analysis. , 2013, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[34]  Manuel Desco,et al.  An innovative tool for intraoperative electron beam radiotherapy simulation and planning: description and initial evaluation by radiation oncologists. , 2012, International journal of radiation oncology, biology, physics.

[35]  Felipe A. Calvo,et al.  Imaging opportunities for treatment planning in intraoperative electron beam radiotherapy (IOERT): Developments in the context of RADIANCE system , 2014 .