title: Applying failure mode effects and criticality analysis in radiotherapy: lessons learned and perspectives of enhancement.
abstract: BACKGROUND
  The 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: IRCCS Istituto Clinico Humanitas, Rozzano, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Scorsetti
authors.forename: Chiara
authors.initials: C
authors.lastname: Signori
authors.forename: Paola
authors.initials: P
authors.lastname: Lattuada
authors.forename: Gaetano
authors.initials: G
authors.lastname: Urso
authors.forename: Mario
authors.initials: M
authors.lastname: Bignardi
authors.forename: Pierina
authors.initials: P
authors.lastname: Navarria
authors.forename: Simona
authors.initials: S
authors.lastname: Castiglioni
authors.forename: Pietro
authors.initials: P
authors.lastname: Mancosu
authors.forename: Paolo
authors.initials: P
authors.lastname: Trucco
mesh_terms: D006801:Humans; D018787:Radiation Oncology / Q000592:standards*; D012307:Risk Factors; D012449:Safety