title: Safety and feasibility of STAT RAD: Improvement of a novel rapid tomotherapy-based radiation therapy workflow by failure mode and effects analysis.
abstract: OBJECTIVE
  The clinical challenge of radiation therapy (RT) for painful bone metastases requires clinicians to consider both treatment efficacy and patient prognosis when selecting a radiation therapy regimen. The traditional RT workflow requires several weeks for common palliative RT schedules of 30 Gy in 10 fractions or 20 Gy in 5 fractions. At our institution, we have created a new RT workflow termed "STAT RAD" that allows clinicians to perform computed tomographic (CT) simulation, planning, and highly conformal single fraction treatment delivery within 2 hours. In this study, we evaluate the safety and feasibility of the STAT RAD workflow.
  
  
  METHODS
  A failure mode and effects analysis (FMEA) was performed on the STAT RAD workflow, including development of a process map, identification of potential failure modes, description of the cause and effect, temporal occurrence, and team member involvement in each failure mode, and examination of existing safety controls. A risk probability number (RPN) was calculated for each failure mode. As necessary, workflow adjustments were then made to safeguard failure modes of significant RPN values. After workflow alterations, RPN numbers were again recomputed.
  
  
  RESULTS
  A total of 72 potential failure modes were identified in the pre-FMEA STAT RAD workflow, of which 22 met the RPN threshold for clinical significance. Workflow adjustments included the addition of a team member checklist, changing simulation from megavoltage CT to kilovoltage CT, alteration of patient-specific quality assurance testing, and allocating increased time for critical workflow steps. After these modifications, only 1 failure mode maintained RPN significance; patient motion after alignment or during treatment.
  
  
  CONCLUSIONS
  Performing the FMEA for the STAT RAD workflow before clinical implementation has significantly strengthened the safety and feasibility of STAT RAD. The FMEA proved a valuable evaluation tool, identifying potential problem areas so that we could create a safer workflow.
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: Ryan T
authors.initials: RT
authors.lastname: Jones
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: Lydia
authors.initials: L
authors.lastname: Handsfield
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Read
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: David D
authors.initials: DD
authors.lastname: Wilson
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: Ray
authors.initials: R
authors.lastname: Van Ausdal
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Schlesinger
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: Jeffrey V
authors.initials: JV
authors.lastname: Siebers
authors.affiliation: Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia. Electronic address: qc3k@virginia.edu.
authors.forename: Quan
authors.initials: Q
authors.lastname: Chen
mesh_terms: D001859:Bone Neoplasms / Q000532:radiotherapy* / Q000556:secondary*; D003198:Computer Simulation; D006801:Humans; D061214:Patient Safety; D011880:Radiotherapy Planning, Computer-Assisted / Q000379:methods*; D018570:Risk Assessment; D012308:Risk Management; D014057:Tomography, X-Ray Computed / Q000379:methods; D057188:Workflow