title: A streamlined failure mode and effects analysis.
abstract: OBJECTIVE
  Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort.
  
  
  METHODS
  FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and used to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project.
  
  
  RESULTS
  Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes had RPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator.
  
  
  CONCLUSIONS
  Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Eric C
authors.initials: EC
authors.lastname: Ford
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Koren
authors.initials: K
authors.lastname: Smith
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Terezakis
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Victoria
authors.initials: V
authors.lastname: Croog
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Smitha
authors.initials: S
authors.lastname: Gollamudi
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Irene
authors.initials: I
authors.lastname: Gage
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Jordie
authors.initials: J
authors.lastname: Keck
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Theodore
authors.initials: T
authors.lastname: DeWeese
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
authors.forename: Greg
authors.initials: G
authors.lastname: Sibley
mesh_terms: D005240:Feasibility Studies; D005260:Female; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D010138:Pacemaker, Artificial / Q000009:adverse effects; D061214:Patient Safety; D011247:Pregnancy; D011252:Pregnancy Complications, Neoplastic / Q000532:radiotherapy; D058996:Quality Improvement; D011878:Radiotherapy / Q000592:standards; D018570:Risk Assessment; D012308:Risk Management / Q000379:methods*; D017749:Total Quality Management; D057188:Workflow