173-1072 / Improving patient safety in assisted reproduction

GOP Information
Organisation sharing the GOP
Related practices from PaSQ database
Agenas- Italian National Agency for Regional Healthcare Services


Quality improvement project
Quality improvement project
Implementation of Patient Safety initiatives / Activities
GOP Description
Implementation level
Clinical settings
Assisted Reproduction (AR) centers
Development, test and validation of tools to be used to improve the safety of patients who undergo assisted reproduction;
Professionals and patients
The GOP methodology is based on the steps outlined below:
–    Setting up of a panel of experts made up by representatives of the National Health Institute (holding the National Registry of Assisted Reproduction), Cittadinanzattiva (Active Citizenship- organization whose aims are the promotion of citizens’ rights) and the Ministry of Health;
–    Analysis of relevant National and International literature and collection of experiences in the field carried out in the Italian regions and in other European countries.
–    Analysis of the AR clinical and organizational processes
Based on the results of the analyses of literature and processes, the phases of the AR care pathway with the highest risk of errors were systematically identified.
Timeframe implementation
14 months
Implementation tools available
A Failure Mode Effect Analysis (FMEA) was carried out on the phases identified. The following tools were identified to be the most helpful to avoid the occurrence of adverse events in AR
–    An adaptation of the WHO surgical safety checklist to be implemented in AR settings
–    Patient safety alert systems for both the patient and the professional involved in the AR process
–    An educational and training program for professionals working in AR centers
They will be tested and validated in the centers belonging to 3 different Regions
Implementation cost
The overall budget estimated for carrying out the project is € 117.500 (it includes implementation of the tools in 3 AR centers)
Method used to measure the results
Professionals working in 3 centers for Assisted Reproduction belonging to 3 different Regions identified and agreed upon the main processes in the AR care pathway. Subsequently, the following 3 phases considered as crucial to ensure patient safety were identified: reception of the couple, identification and traceability (including pick-up and transfer), organization of the pharmacological treatment plan.
The FMEA carried out on the above phases allowed to identify the highest Risk Priority Numbers (RPN) reported below.
The highest RPNs identified thanks to the FMEA concern the sub-phases:
Hormonal check up and echographic monitoring- the professional does not realize the treatment must be modified: RPN 324; the patient does not understand the new therapeutic instructions: RPN 320
Pick up- wrong timing in delivering the patient to the operating room staff: RPN 405; wrong application of the surgical safety checklist (adverse drug reactions: RPN 504; no antibiotic administration: RPN 384)
Analysis of the results
The objectives of the project have been fully reached. Moreover, during the focus groups the need has arisen to address another important step in the AR care pathway, that is to say the misunderstanding or non-understanding of therapeutic protocol (due to linguistic difficulties or wrong/mis-communication from the physician) that could lead to adverse drug reaction or miscarriage.
Therefore all the stakeholders involved in the project agreed upon the need to identify any experiences/good practices/protocols implemented at the local level as well as in other European countries to overcome the problem.
Implementation barriers
Did you find implementation barriers?
Please describe implementation barriers
The main challenge we faced was to make professionals, institutions, experts and citizens’ organizations work together.
Describe the strategies used to overcome the barriers (If needed)
We set up a coordination group made up by representatives of the main institutions working in the field of AR, clinicians and citizens’ representatives. Therefore, every step of the project was shared and agreed upon by all the relevant stakeholders.
Other information
Other information about the GOP that you would like to add (Link or attached document)
The value of the project lies in the fact that for the first time all the stakeholders have collaborated in the development of tools to enhance patient safety in AR in Italy.