title: Failure mode and effective analysis ameliorate awareness of medical errors: a 4-year prospective observational study in critically ill children.
abstract: BACKGROUND
  Errors in are estimated to occur with an incidence of 3.7-16.6% in hospitalized patients. The application of systems for detection of adverse events is becoming a widespread reality in healthcare. Incident reporting (IR) and failure mode and effective analysis (FMEA) are strategies widely used to detect errors, but no studies have combined them in the setting of a pediatric intensive care unit (PICU).
  
  
  OBJECTIVE
  The aim of our study was to describe the trend of IR in a PICU and evaluate the effect of FMEA application on the number and severity of the errors detected.
  
  
  METHODS
  With this prospective observational study, we evaluated the frequency IR documented in standard IR forms completed from January 2009 to December 2012 in the PICU of Woman's and Child's Health Department of Padova. On the basis of their severity, errors were classified as: without outcome (55%), with minor outcome (16%), with moderate outcome (10%), and with major outcome (3%); 16% of reported incidents were 'near misses'. We compared the data before and after the introduction of FMEA.
  
  
  RESULTS
  Sixty-nine errors were registered, 59 (86%) concerning drug therapy (83% during prescription). Compared to 2009-2010, in 2011-2012, we noted an increase of reported errors (43 vs 26) with a reduction of their severity (21% vs 8% 'near misses' and 65% vs 38% errors with no outcome).
  
  
  CONCLUSIONS
  With the introduction of FMEA, we obtained an increased awareness in error reporting. Application of these systems will improve the quality of healthcare services.
authors.affiliation: Department of Woman's and Child's Health, Pediatric Residency Program, University of Padova, Padova, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Daverio
authors.affiliation: Department of Woman's and Child's Health, Pediatric Residency Program, University of Padova, Padova, Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Fino
authors.affiliation: Education and Training Department, University-Hospital, Padova, Italy.
authors.forename: Brugnaro
authors.initials: B
authors.lastname: Luca
authors.affiliation: Pediatric Intensive Care Unit, Department of Woman's and Child's Health, University-Hospital, Padova, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Zaggia
authors.affiliation: Pediatric Intensive Care Unit, Department of Woman's and Child's Health, University-Hospital, Padova, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Pettenazzo
authors.affiliation: Quality Assurance Service, University-Hospital, Padova, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Parpaiola
authors.affiliation: Quality Assurance Service, University-Hospital, Padova, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Lago
authors.affiliation: Pediatric Intensive Care Unit, Department of Woman's and Child's Health, University-Hospital, Padova, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Amigoni
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness / Q000628:therapy*; D004282:Documentation; D004358:Drug Therapy / Q000592:standards; D005568:Forms and Records Control; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric / Q000458:organization & administration* / Q000592:standards; D019300:Medical Errors / Q000517:prevention & control*; D011446:Prospective Studies; D058996:Quality Improvement; D012308:Risk Management; D013647:Task Performance and Analysis; D017211:Treatment Failure; D016896:Treatment Outcome
keywords: critical care; healthcare quality; incident reporting; medical errors; pediatric intensive care unit