P-224

Islets graft preparation in an ISO 9001-certified laboratory for a safety clinical application

R.M. Goebbels, N. Aouassar, D. Xhema, D. Dufrane
University clinical hospital Saint-Luc, Brussels, Belgium

Objective: The aim of this work consists to the ISO certification based on the control of all the processes taking place in the laboratory activity to provide reproducibility, safety and security to the graft and, in so doing, to the patient. Our purpose is to present how we worked to obtain this certification and how we continue to operate to maintain it.

Materials: The main processes are fourfold: Management, Operational, Support, and Quality management/improvement. We divided the operational processes in sub - processes that come one after another. The main sub-processes are (i) pancreas procurement/acceptation/treatment, (ii) islets graft liberation, deliverance and (iii) graft implantation/follow-up. All specifications and requirements are clearly described in Standard Operating Procedures (SOP) and carefully documented for all islets isolations . Supports were identified as all the structures linked to the activity: the infrastructure itself, the environment and the HVAC system, the equipment, the purchases and suppliers, the archives , as well as the human and financial resources.

Results: In our structure, the quality insurance plays two different roles; its first and basic role consists in the maintenance of Standard Operating Procedures describing all the sub-mentioned processes. Its second role is the continuous improvement of the quality by using tools such as quality indicators, root causes analysis, risk analysis, corrective/ preventive actions, as well as stimulating the implication of all the staff members together with the medical management team, which is perhaps the most important task.

Conclusion: Reaching the ISO 9001 certification can improve the worldwide reproducibility of human islets transplantation.

P-224

Islets graft preparation in an ISO 9001-certified laboratory for a safety clinical application

R.M. Goebbels, N. Aouassar, D. Xhema, D. Dufrane
University clinical hospital Saint-Luc, Brussels, Belgium

Objective: The aim of this work consists to the ISO certification based on the control of all the processes taking place in the laboratory activity to provide reproducibility, safety and security to the graft and, in so doing, to the patient. Our purpose is to present how we worked to obtain this certification and how we continue to operate to maintain it.

Materials: The main processes are fourfold: Management, Operational, Support, and Quality management/improvement. We divided the operational processes in sub - processes that come one after another. The main sub-processes are (i) pancreas procurement/acceptation/treatment, (ii) islets graft liberation, deliverance and (iii) graft implantation/follow-up. All specifications and requirements are clearly described in Standard Operating Procedures (SOP) and carefully documented for all islets isolations . Supports were identified as all the structures linked to the activity: the infrastructure itself, the environment and the HVAC system, the equipment, the purchases and suppliers, the archives , as well as the human and financial resources.

Results: In our structure, the quality insurance plays two different roles; its first and basic role consists in the maintenance of Standard Operating Procedures describing all the sub-mentioned processes. Its second role is the continuous improvement of the quality by using tools such as quality indicators, root causes analysis, risk analysis, corrective/ preventive actions, as well as stimulating the implication of all the staff members together with the medical management team, which is perhaps the most important task.

Conclusion: Reaching the ISO 9001 certification can improve the worldwide reproducibility of human islets transplantation.