title: Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure.
abstract: Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process.
  
  
  
  We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority.
  
  
  
  The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100.
  
  
  
  This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.
authors.affiliation: MD, Post Graduate School of Public Health, University of Siena, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Serafini
authors.affiliation: MD, Post Graduate School of Public Health, University of Siena, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Troiano
authors.affiliation: Laboratory Technician, Clinical Pathology Unit, "Le Scotte" Teaching Hospital, Siena, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Franceschini
authors.affiliation: Biologist, Clinical Pathology Unit, "Le Scotte" Teaching Hospital, Siena, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Calzoni
authors.affiliation: Full Professor, Health Service Research Laboratory and Post Graduate School of Public Health, University of Siena, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Nante
authors.affiliation: MD, Clinical Pathology Unit, "Le Scotte" Teaching Hospital, Siena, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Scapellato
mesh_terms: D020016:Activated Protein C Resistance / Q000097:blood / Q000175:diagnosis*; D015415:Biomarkers / Q000097:blood; D001780:Blood Coagulation Tests / Q000379:methods / Q000592:standards*; D001800:Blood Specimen Collection / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D005165:Factor V / Q000378:metabolism*; D006801:Humans; D007558:Italy; D011237:Predictive Value of Tests; D011336:Probability; D018570:Risk Assessment; D012308:Risk Management / Q000592:standards*; D012680:Sensitivity and Specificity; D013597:Systems Analysis
chemical_list: D015415:Biomarkers; C095381:factor V Leiden; D005165:Factor V
keywords: Clinical laboratory; FMECA; Hematology; Quality; Risk management