title: A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy.
abstract: OBJECTIVE
  To improve the quality of our gynecologic brachytherapy practice and reduce reportable events, we performed a process analysis after the failure modes and effects analysis (FMEA).
  
  
  METHODS
  The FMEA included a multidisciplinary team specifically targeting the tandem and ring brachytherapy procedure. The treatment process was divided into six subprocesses and failure modes (FMs). A scoring guideline was developed based on published FMEA studies and assigned through team consensus. FMs were ranked according to overall and severity scores. FM ranking >5% of the highest risk priority number (RPN) score was selected for in-depth analysis. The efficiency of each existing quality assurance to detect each FM was analyzed.
  
  
  RESULTS
  We identified 170 FMs, and 99 were scored. RPN scores ranged from 1 to 192. Of the 13 highest-ranking FMs with RPN scores >80, half had severity scores of 8 or 9, with no mode having severity of 10. Of these FM, the originating process steps were simulation (5), treatment planning (5), treatment delivery (2), and insertion (1). Our high-ranking FM focused on communication and the potential for applicator movement. Evaluation of the efficiency and the comprehensiveness of our quality assurance program showed coverage of all but three of the top 49 FMs ranked by RPN.
  
  
  CONCLUSIONS
  This is the first reported FMEA process for a comprehensive gynecologic brachytherapy procedure overview. We were able to identify FMs that could potentially and severely impact the patient's treatment. We continue to adjust our quality assurance program based on the results of our FMEA analysis.
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA. Electronic address: jmayadev@ucdavis.edu.
authors.forename: Jyoti
authors.initials: J
authors.lastname: Mayadev
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Sonja
authors.initials: S
authors.lastname: Dieterich
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Rick
authors.initials: R
authors.lastname: Harse
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Susan
authors.initials: S
authors.lastname: Lentz
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Mathew
authors.initials: M
authors.lastname: Mathai
authors.affiliation: Department of Radiation Oncology, Scott and White Memorial Hospital, Temple, TX.
authors.forename: Sunita
authors.initials: S
authors.lastname: Boddu
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Marianne
authors.initials: M
authors.lastname: Kern
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Jean
authors.initials: J
authors.lastname: Courquin
authors.affiliation: Department of Radiation Oncology, University of California Davis Medical Center, Sacramento, CA.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Stern
mesh_terms: D001918:Brachytherapy / Q000592:standards*; D005260:Female; D005833:Genital Neoplasms, Female / Q000532:radiotherapy*; D000067495:Healthcare Failure Mode and Effect Analysis / Q000379:methods* / Q000458:organization & administration; D006801:Humans; D017064:Process Assessment, Health Care / Q000379:methods*; D011785:Quality Assurance, Health Care
keywords: Brachytherapy; Gynecologic oncology; Quality assurance