A Customized Tool of Incident Reporting for the Detection of Nonconformances at a Single IVF Center: Development, Application, and Efficacy

Table 1

Steps of development of the IVF-customized IR tool.

Date	Activities
July 2013	(1) Publication of the regional document 972/2013 that introduced mandatory operating instructions in healthcare facilities according to the Italian State-Regions Conference of March 15th/2012
August 2013-August 2014	(1) Definition of NCs potentially occurring in the IVF laboratory; (2) Attempts to report and discuss NCs through paper archives; (3) Recruitment of an expert and multidisciplinary team; (4) Identification of needs to be addressed by the tool; (5) Definition of strategy to develop the IVF-customized IR system
September 2014-October 2014	(1) Creation of a form accessible to all users in a time-saving manner; (2) Attempts in NCs recording; (3) Set-up of record extrapolation to spreadsheets
November 2014-December 2014	(1) Validation of the IVF-customized IR system; (2) Availability of the tool inside the intranet of the hospital
January 2015-at present	(1) NCs reporting by all the IVF staff; (2) Monthly and yearly extrapolation of records; (3) Discussion among IVF staff members; (4) Monitoring of corrective action implemented by Clinical Risk Manager

IVF = in vitro fertilization; NCs = nonconformances.