A1c4 Incorrect / absent Human error or Reduced 1 3 2 6 Witnessing 1 3 1 3 registration data negligence traceability / data loss A.2 Sperm A2a Patient A1a1 Patient mismatch Incorrect labelling Sperm 5 1 5 25 Witnessing, the 5 1 1 5 preparation identification due to human error mismatch patient signs his own labels A2b Sample A2b1 Biological sample Correctly labelled, mismatch 5 1 5 25 Colour code and 5 1 1 5 identification mismatch but tube mismatch witnessing due to human error A2c Sample A2c1 Not working or Technical failure Sample damage 2 3 1 6 Calibration and 2 2 1 4 processing uncalibrated equipment maintenance of all critical instruments A2c2 Time and Lack of training or Sample damage 4 2 1 8 Staff training 4 1 1 4 conditions not operator's respected negligence A2c3 Incorrect media Lack of training or Sample 4 2 2 16 training 4 1 2 8 preparation operator's contamination / negligence impaired semen quality A2c4 Incorrect/absent Human error or Reduced 1 3 2 6 Witnessing 1 3 1 3 registration data negligence traceability / data loss A.3 IVF or ICSI A3a Sample A3a1 Biological sample Incorrect labelling Oocyte and 5 1 5 25 Witnessing 5 1 1 5 identification mismatch due to error sperm mismatch A3b1 A3b Not Sample working or Technical failure Sample damage 2 3 1 6 Calibration and 2 2 1 4 uncalibrated processing equipment maintenance of all critical instruments
A1c4 Incorrect / absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.2 Sperm preparation A2a Patient identification A1a1 Patient mismatch Incorrect labelling due to human error Sperm mismatch 5 1 5 25 Witnessing, the patient signs his own labels 5 1 1 5 A2b Sample identification A2b1 Biological sample mismatch Correctly labelled, but tube mismatch due to human error mismatch 5 1 5 25 Colour code and witnessing 5 1 1 5 A2c Sample processing A2c1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4 A2c2 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 2 1 8 Staff training 4 1 1 4 A2c3 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired semen quality 4 2 2 16 training 4 1 2 8 A2c4 Incorrect/absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.3 IVF or ICSI A3a Sample identification A3a1 Biological sample mismatch Incorrect labelling due to error Oocyte and sperm mismatch 5 1 5 25 Witnessing 5 1 1 5 A3b Sample processing A3b1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4
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