Evaluation audit of cytotoxic preparation isolator bio-cleaning practices according to 2022 Good Preparation Practices following positive bacteriological surface samples

Background and Objectives
Since 2015, the activity of the Cytotoxic Reconstitution Unit (CRU), which performs high-risk sterile preparations, has been increasing. Three new Hospital Pharmacy Technicians (HPT) were trained over 18 months. In September 2023, two samples taken from the isolator tested positive for environmental germs. This raised questions about the practices of the HPT. It was decided to carry out an audit as part of the self-assessment of our practices. The purpose of this audit is to review the practices of the HPT working under isolators to determine if the steps described in the Good Preparation Practices (GPP) for setting up and taking down in the isolator are being correctly carried out.

Materials and Methods
The new GPP and the internal bio-cleaning procedure at the CRU were used to develop an audit checklist. This checklist includes the tasks that HPT must perform during their setup and takedown in the isolator. All CRU HPT were visually audited by the intern. The responses have been recorded in an Excel spreadsheet for result analysis. A new procedure regarding the setup and takedown of HPT in the isolator was drafted and presented to the staff along with the audit results.

Results
The audit reveals that during setup, all HPT keep their work area clear, place a sterile drape correctly, and wear sterile gloves over the neoprene isolator gloves. However, only 33% check the integrity of the neoprene gloves before starting their preparation shift. Additionally, changing gloves and sterile drape every hour is only done in 66% of cases. Finally, none of the HPT perform bio-cleaning at the beginning of their shift. During takedown, we could note that all HPT clean and tidy the isolator. Neoprene gloves checks are done in 83% of cases and sleeve checks are performed weekly.

Discussion - Conclusion
This audit enabled us to analyze HPT practices during their setup and takedown in the isolator. Some steps were not performed despite several reminders of their importance, such as bio-cleaning and checking the integrity of the sleeves and neoprene gloves at the beginning and end of the shift. Knowledge of the new GPP by the HPT is essential since they have been enforceable since September 2023. A procedure for setup and takedown in the isolator, a follow-up checklist, and training for CRU staff have been implemented, reminding them of the practices and their importance. The audit will need to be repeated to ensure follow-up and limit deviations in practice.

See the poster