Identifying human error in the IVF laboratory using electronic witnessing Xavier Orriols Brunetti1, Sophie Bird1, Lourdes Muriel Rios1, Shaun Rogers1, Alan Thornhill 1,2

1The London Bridge Fertility, Gynaecology and Genetics Centre, London, UK

2Department of Biosciences, The University of Kent, Canterbury, UK.

Aim: Electronic witnessing was introduced in IVF laboratories to prevent catastrophic errors and provide an automated solution to regulatory requirements for double witnessing. Following validation involving manual witnessing in parallel, an electronic witnessing system (RI-WitnessTM) has been used continuously for 13 months in our laboratory. We investigated the incidence of errors and frequency of difficulties encountered while using the system.

Method: RI-WitnessTM uses Radio Frequency Identification (RFID) technology to track patient samples at each predefined step of the IVF process. Workstations equipped with RFID readers accompanied by touch screens record every action involving tagged items. Self-adhesive RFID tags placed on all cultureware destined to contain gametes or embryos enable readers to register tagged cultureware in any workstation area thereby monitoring patient identity throughout. Specifically we assessed the (i) true mismatch rate (i.e. introducing pre-allocated tags to work area whilst mid-procedure involving another patient); (ii) distribution and duration of mismatches (iii) incidence of additional interventions required as a consequence of using RI-WitnessTM.

Results: The study period (12/2010-1/2012) involved 1499 patients, 17435 witness steps and 19880 tags. The total mismatch rate was 51/17435 (0.29%). Excluding 24 flow-chart related mismatches (including system failures related to initial configuration e.g. cycles involving donor and recipient) and pre-allocated tags within the frequency range of the reader but outside of the workstation (6/17435), the true mismatch rate was 0.12% (21/17435). All true mismatches were rectified in <10 seconds and their distribution was not confined to specific procedures or times of day. Excluding pre-determined double manual witnessing steps, only 1% of all electronic witness steps required additional intervention from a second person.

Conclusion: RI-WitnessTM is reliable and accurately records and time-stamps all laboratory procedures, identifying a low true mismatch rate (0.12%) which compares favourably with published error rates of 0.21- 5% for similar laboratory activities.