title: [Modal failure analysis and effects in the detection of errors in the transport of samples to the clinical laboratory].
abstract: OBJECTIVE
  Owing to the decrease in values of biochemical glucose parameter in some samples from external extraction centres, and the risk this implies to patient safety; it was decided to apply an adaptation of the «Health Services Failure Mode and Effects Analysis» (HFMEA) to manage risk during the pre-analytical phase of sample transportation from external centres to clinical laboratories.
  
  
  METHODS
  A retrospective study of glucose parameter was conducted during two consecutive months. The analysis was performed in its different phases: to define the HFMEA topic, assemble the team, graphically describe the process, conduct a hazard analysis, design the intervention and indicators, and identify a person to be responsible for ensuring completion of each action.
  
  
  RESULTS
  The results of glucose parameter in one of the transport routes, were significantly lower (P=.006). The errors and potential causes of this problem were analysed, and criteria of criticality and detectability were applied (score≥8) in the decision tree. It was decided to: develop a document management system; reorganise extractions and transport routes in some centres; quality control of the sample container ice-packs, and the time and temperature during transportation.
  
  
  CONCLUSIONS
  This work proposes quality indicators for controlling time and temperature of transported samples in the pre-analytical phase. Periodic review of certain laboratory parameters can help to detect problems in transporting samples. The HFMEA technique is useful for the clinical laboratory.
authors.affiliation: Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España. Electronic address: laura.pares@salud.madrid.org.
authors.forename: L
authors.initials: L
authors.lastname: Parés-Pollán
authors.affiliation: Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España.
authors.forename: A
authors.initials: A
authors.lastname: Gonzalez-Quintana
authors.affiliation: Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España.
authors.forename: J
authors.initials: J
authors.lastname: Docampo-Cordeiro
authors.affiliation: Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España.
authors.forename: C
authors.initials: C
authors.lastname: Vargas-Gallego
authors.affiliation: Dirección Médica de Continuidad Asistencial, Hospital universitario 12 de Octubre, Madrid, España.
authors.forename: G
authors.initials: G
authors.lastname: García-Álvarez
authors.affiliation: Subdirección Médica de Servicios Centrales, Hospital universitario 12 de Octubre, Madrid, España.
authors.forename: V
authors.initials: V
authors.lastname: Ramos-Rodríguez
authors.affiliation: Servicio de Análisis Clínicos/Bioquímica, Hospital universitario 12 de Octubre, Madrid, España.
authors.forename: M P
authors.initials: MP
authors.lastname: Diaz Rubio-García
mesh_terms: D064790:Clinical Laboratory Services; D003951:Diagnostic Errors; D006801:Humans; D012189:Retrospective Studies; D018570:Risk Assessment; D013048:Specimen Handling / Q000592:standards*
keywords: Accreditation; Acreditación; Calidad; Diagnostic errors; Errores de diagnóstico; Gestión del riesgo; Manipulación de muestras; Patient safety; Quality; Risk management; Seguridad del paciente; Specimen handling