title: Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF.
abstract: Traceability of cells during IVF is a fundamental aspect of treatment, and involves witnessing protocols. Failure mode and effects analysis (FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with witnessing protocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic witnessing system (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual witnessing system is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the witnessing process, identifying critical steps and planning changes in practice to enable safety to be enhanced.
authors: GENERA Centres for Reproductive Medicine, Clinica Valle Giulia Rome, Salus Marostica, Poliambulatorio Umbertide, Clinica Ruesch Naples, Italy. Electronic address: rienzi@generaroma.it.
authors: Laura
authors: L
authors: Rienzi
authors: Italian National Transplant Centre (CNT), Istituto Superiore di Sanità, Rome, Italy.
authors: Fiorenza
authors: F
authors: Bariani
authors: Centro Trasfusionale, Ulss 9, Treviso, Italy.
authors: Michela
authors: M
authors: Dalla Zorza
authors: GENERA Centres for Reproductive Medicine, Clinica Valle Giulia Rome, Salus Marostica, Poliambulatorio Umbertide, Clinica Ruesch Naples, Italy.
authors: Stefania
authors: S
authors: Romano
authors: GENERA Centres for Reproductive Medicine, Clinica Valle Giulia Rome, Salus Marostica, Poliambulatorio Umbertide, Clinica Ruesch Naples, Italy.
authors: Catello
authors: C
authors: Scarica
authors: GENERA Centres for Reproductive Medicine, Clinica Valle Giulia Rome, Salus Marostica, Poliambulatorio Umbertide, Clinica Ruesch Naples, Italy.
authors: Roberta
authors: R
authors: Maggiulli
authors: Italian National Transplant Centre (CNT), Istituto Superiore di Sanità, Rome, Italy.
authors: Alessandro
authors: A
authors: Nanni Costa
authors: GENERA Centres for Reproductive Medicine, Clinica Valle Giulia Rome, Salus Marostica, Poliambulatorio Umbertide, Clinica Ruesch Naples, Italy.
authors: Filippo Maria
authors: FM
authors: Ubaldi
mesh_terms: D005260:Female; D005307:Fertilization in Vitro / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D000067495:Healthcare Failure Mode and Effect Analysis / Q000379:methods*; D006801:Humans; D008297:Male; D064406:Patient Harm / Q000517:prevention & control; D010355:Patient Identification Systems / Q000379:methods; D011247:Pregnancy; D012384:Rome; D012449:Safety
keywords: FMEA; IVF; embryos; mismatch; traceability; witness