title: A practical framework for patient care teams to prospectively identify and mitigate clinical hazards.
abstract: BACKGROUND
  One of the greatest challenges facing both practitioners and risk managers is the identification of previously unknown clinical hazards and defects. With the rapid proliferation of new health care services, unknown hazards may propagate as new therapies are integrated into the existing health care system. The main goal of risk analysis is to make these hazards visible by proactively searching and probing the system. Yet, a comprehensive approach by which to safely integrate new therapies into the existing clinical environment has yet to be clearly articulated. Patient care teams can use the proposed framework when introducing new therapies.
  The framework includes a background investigation and literature search; an in situ simulation (in the actual clinical setting used for patients); a Failure Mode and Effects Analysis to determine the severity, probability, and risk of the potential hazards; and a multidisciplinary protocol and safety checklist to standardize practice and ensure provider accountability.
  
  
  METHODS
  Application of this framework to three operative scenarios--intraoperative radiation therapy (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC), and an interventional pulmonology program--demonstrates its flexibility. Its use prospectively identified and mitigated 20 IORT, 5 HIPEC, and 18 interventional pulmonology hazards/defects. Subsequent patient cases were largely uneventful. All cases and patient safety reporting systems are monitored to identify any new defects in an effort to continuously improve patient care.
  
  
  CONCLUSIONS
  The use of a comprehensive framework to identify and mitigate hazards in an on-site simulated environment promotes safer care for target patient populations; results in familiarity with procedures, amelioration of staff concerns, and standardization of practice; and facilitates teamwork and communication.
authors.affiliation: Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, USA. kherzer@jhmi.edu
authors.forename: Kurt R
authors.initials: KR
authors.lastname: Herzer
authors.forename: Jose M
authors.initials: JM
authors.lastname: Rodriguez-Paz
authors.forename: Peter A
authors.initials: PA
authors.lastname: Doyle
authors.forename: Paul W
authors.initials: PW
authors.lastname: Flint
authors.forename: David J
authors.initials: DJ
authors.lastname: Feller-Kopman
authors.forename: Joseph
authors.initials: J
authors.lastname: Herman
authors.forename: Robert E
authors.initials: RE
authors.lastname: Bristow
authors.forename: Renee
authors.initials: R
authors.lastname: Cover
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Pronovost
authors.forename: Lynette J
authors.initials: LJ
authors.lastname: Mark
mesh_terms: D006296:Health Services / Q000592:standards*; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control*; D010348:Patient Care Team / Q000458:organization & administration* / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods; D018570:Risk Assessment / Q000379:methods; D017751:Safety Management / Q000379:methods*