Comprehensive protocol of traceability during IVF: The result of a multicentre failure mode and effect analysis

Laura Rienzi, Fiorenza Bariani, M. Dalla Zorza, E. Albani, F. Benini, S. Chamayou, M.G. Minasi, L. Parmegiani, L. Restelli, G. Vizziello, Alessandro Nanni Costa

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STUDY QUESTION Can traceability of gametes and embryos be ensured during IVF? SUMMARY ANSWER The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. WHAT IS KNOWN ALREADY Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. STUDY DESIGN, SIZE, DURATION Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. PARTICIPANTS/MATERIALS, SETTING, METHODS In each centre, this study involved: the laboratory director, the Quality Control & Quality Assurance responsible, Embryologist(s), Gynaecologist(s), Nurse(s) and Administration. The FMEA analyses were performed according to the Joint Commission International. MAIN RESULTS AND THE ROLE OF CHANCE The FMEA teams identified seven main process phases: oocyte collection, sperm collection, gamete processing, insemination, embryo culture, embryo transfer and gamete/embryo cryopreservation. A mean of 19.3 (SD ± 5.8) associated process steps and 41.9 (SD ± 12.4) possible failure modes were recognized per centre. A RPN ≥15 was calculated in a mean of 6.4 steps (range 2-12, SD ± 3.60). A total of 293 failure modes were centrally analysed 45 of which were considered at medium/high risk. After consistent corrective measures implementation and re-evaluation, a significant reduction in the RPNs in all centres (RPN
Original languageEnglish
Pages (from-to)1612-1620
Number of pages9
JournalHuman Reproduction
Issue number8
Publication statusPublished - Aug 2017


  • embryo mismatch
  • failure mode and effect analysis
  • IVF
  • risk analysis
  • traceability
  • witness
  • clinical trial
  • controlled clinical trial
  • controlled study
  • cryopreservation
  • decision making
  • embryo
  • embryo culture
  • embryo transfer
  • embryology
  • error
  • female
  • funding
  • gamete
  • genetic screening
  • gynecologist
  • human
  • human cell
  • implantation
  • insemination
  • joint
  • male
  • multicenter study
  • national health organization
  • nurse
  • oocyte donation
  • quality control
  • registration
  • risk assessment
  • sperm
  • study design
  • validity


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