Roberta Maggiulli. Centro GENERA Medicina della Riproduzione Roma, Marostica, Napoli, Umbertide

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1 Roberta Maggiulli Centro GENERA Medicina della Riproduzione Roma, Marostica, Napoli, Umbertide

5 Significant increase in the number of IVF cycles performed at our centre Need to improve our lab efficiency Double manual witnessing is time consuming and distracting Concept of Involuntary automaticity the second witness may see what he expected to see

witnessing is time consuming and distracting Concept of

6 Electronic witnessing RFID Tags Radio frequency identification labels (IVFWitnessTM, UK) RFID Tag Reader Barcodes (MatcherTM, FertilityQMS Ltd, UK) RFID reader Scanner RFID Patient Card Controlling software

Reader Barcodes (MatcherTM, FertilityQMS Ltd, UK)

7 Timing required for an ex-novo installation of an electronic witnessing system (RI Witness ) into a busy IVF clinic: to integrate and install the system in the working area for the setting and configuration of the working flow-chart Patient Satisfaction for the training of all the clinical embryologists

system in the working area for the setting and configuration of the working

8 Work Area Readers Controlling Software 4 working days PC Ad Monitor Barcode Reader Training of Laboratory Staff STAFF TRAININ G 7 working days

9 Adjustment of the system workflow according to our laboratory s existing protocols Reduction of the system users errors to less than 1% Double manual witnessing simultaneously performed True mismatches = mismatches derived from a simultaneous presence of two different patient samples in the working area Secondary mismatches = mismatches derived from acceptable common errors (i.e. preallocated tags within the frequency range of the reader, but outside of the workstation)

simultaneous presence of two different patient samples in the working area Secondary mismatches = mismatches derived

11 Validation period Post-validation period Patients (N) Witnessing steps (N) % (17/2099) 0.66% (39/5921) True mismatch rate (%) 0.09% (2/2099) 0.10% (6/5921) Secondary mismatch rate (%) 0.71% (15/2099) 0.56% (33/5921) Mismatch rate (%) 0.1% mismatch/step x 7 steps/cycle = ~0.7% mismatch/cycle x 0.25 pregnancy/cycle= ~0.17% mismatch/pregnancy

10% (6/5921) Secondary mismatch rate (%) 0.71% (15/2099) 0.

13 A secure system providing exit and entry point management between the Lab & cryopreservation using Brady barcode labels.

16 PGS Cycles Aneuploid Euploid

17 To provide a proof of concept for a direct oocyte/embryo labeling system

18 Novo et al., 2011

19 In vitro development of embryos microinjected with different types of polysilicon barcodes into their perivitelline space. Magnified images of the barcodes MOUSE MODEL Remaining barcodes Novo et al., 2011

20 HUMAN OOCYTES Novo et al., 2013

21 Novo et al., 2013

22 06/18/14 22

23 06/18/14 Sociodemographic variables: Age Gender Education Previous IVF treatments A likert scale of values ranging from 0 to 6 has been assigned to each answer 23

24 06/18/14 Awared of IVF mix-up risk? Yes, definitely: 11.9% (28/236) Yes, vaguely: 64.8 % (153/236) Concerned about IVF mixup? No: 8.5% (20/236) No: 23.3% (55/236) Yes, definitely: 39.8% (94/236) Yes, quite: 51.7% (122/236)

25 06/18/14 Anxiety reduction with EW No: 6.8% 16/236) ELECTRONIC WITNESSING Yes, definitely: 80.9 (191/236) Yes, vaguely: 12.3 % (29/236)

26 06/18/14 Traceability Yes, vaguely: 11,8% (28/236) No: 1.3% (3/236) Yes, definitely: 86.9% (2505/236) Patients reassurance Yes, quite: 39.8% (94/236) Yes, definitely: 51.7% (122/236) Multiple logistic regression analysis did not revealed any influence of socio-demographic variables on patient s attitudes toward IVF electronic witness system.

27 Easy to implement Safeguards the reliability of the entire IVF process Traceability of each step performed Reduction of staff workload and distractions Patients reassurance

28 CLINICA VALLE GIULIA, Roma SALUS ASI MEDICAL, Marostica GENERA UMBERTIDE, Perugia CLINICAL DIRECTOR: Filippo Maria Ubaldi LABORATORY DIRECTOR: Laura Rienzi Rome Elena Baroni Silvia Colamaria Maddalena Giuliani Susanna Ferrero Fabio Sapienza Marostica Antonio Ciconte Silvia Venanzi Laura Buffo Antonio Gugole Angelo Moratello CIPA Michele Ermini Beatrice Ermini Umbertide Antonio Angelini Emanuela Migliorati Fabrizio Fiorini Rome Stefania Romano Roberta Maggiulli Laura Albricci Antonio Capalbo Federica Sanges Catello Scarica Elena Ievoli Lisa Dovere Marta Stoppa Danilo Cimadomo Giovanna Orlando Emiliano Scepi Erminia Alviggi Mauro Schimberni Annalise Giallonardo Giovanna Vettraino Marostica Benedetta Iussig Ludovica Dusi Sara Bertelle Umbertide Nicoletta Barnocchi Letizia Papini

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