title: A novel process for introducing a new intraoperative program: a multidisciplinary paradigm for mitigating hazards and improving patient safety.
abstract: BACKGROUND
  Since the Institute of Medicine's report, To Err is Human, was published, numerous interventions have been designed and implemented to correct the defects that lead to medical errors and adverse events; however, most efforts were largely reactive. Safety, communication, team performance, and efficiency are areas of care that attract a great deal of attention, especially regarding the introduction of new technologies, techniques, and procedures. We describe a multidisciplinary process that was implemented at our hospital to identify and mitigate hazards before the introduction of a new technique: high-dose-rate intraoperative radiation therapy, (HDR-IORT).
  
  
  METHODS
  A multidisciplinary team of surgeons, anesthesiologists, radiation oncologists, physicists, nurses, hospital risk managers, and equipment specialists used a structured process that included in situ clinical simulation to uncover concerns among care providers and to prospectively identify and mitigate defects for patients who would undergo surgery using the HDR-IORT technique.
  
  
  RESULTS
  We identified and corrected 20 defects in the simulated patient care process before application to actual patients. Subsequently, eight patients underwent surgery using the HDR-IORT technique with no recurrence of simulation-identified or unanticipated defects.
  
  
  CONCLUSIONS
  Multiple benefits were derived from the use of this systematic process to introduce the HDR-IORT technique; namely, the safety and efficiency of care for this select patient population was optimized, and this process mitigated harmful or adverse events before the inclusion of actual patients. Further work is needed, but the process outlined in this paper can be universally applied to the introduction of any new technologies, treatments, or procedures.
authors.affiliation: Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA. jrodrig1@jhmi.ed
authors.forename: Jose M
authors.initials: JM
authors.lastname: Rodriguez-Paz
authors.forename: Lynette J
authors.initials: LJ
authors.lastname: Mark
authors.forename: Kurt R
authors.initials: KR
authors.lastname: Herzer
authors.forename: James D
authors.initials: JD
authors.lastname: Michelson
authors.forename: Kelly L
authors.initials: KL
authors.lastname: Grogan
authors.forename: Joseph
authors.initials: J
authors.lastname: Herman
authors.forename: David
authors.initials: D
authors.lastname: Hunt
authors.forename: Linda
authors.initials: L
authors.lastname: Wardlow
authors.forename: Elwood P
authors.initials: EP
authors.lastname: Armour
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Pronovost
mesh_terms: D000328:Adult; D000368:Aged; D001918:Brachytherapy / Q000009:adverse effects*; D002985:Clinical Protocols; D003198:Computer Simulation; D019091:Critical Pathways; D005260:Female; D006801:Humans; D033183:Interdisciplinary Communication; D007430:Intraoperative Care; D007431:Intraoperative Complications / Q000517:prevention & control*; D008297:Male; D008348:Manikins; D019300:Medical Errors / Q000517:prevention & control*; D008875:Middle Aged; D009369:Neoplasms / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D010348:Patient Care Team; D016730:Program Development; D015397:Program Evaluation; D011446:Prospective Studies; D011829:Radiation Dosage; D011832:Radiation Injuries / Q000517:prevention & control*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D018570:Risk Assessment; D017751:Safety Management