Quality and safety

Quality Management

Of great importance to FBTV is the quality of the processes, from donor selection to distribution, which, together with research, guarantee a high standard of the tissues distributed.

Respecting ethical principles and current regulations, the Foundation does its utmost to achieve the highest quality standards, with scrupulous compliance with good laboratory practices and constant monitoring of all processes that guarantee the high level of quality provided.

Safety and Quality

One of the main requirements of tissue transplantation is to guarantee safety, which starts with the correct selection of the donor, an essential element in minimising the possibility of disease transmission.

To guarantee the safety of the tissues distributed, FBTV carries out a careful selection through an in-depth analysis that evaluates the donor’s medical and social history, clinical status, physical examination, and serological test results, in order to rule out any risk factors. In addition, every step is documented and clearly traced. All documentation regarding donor history and tissue processing information is made available to the transplanting surgeon, and each tissue distributed is accompanied by documentation certifying the quality and safety of the tissue.

Through the Quality Management System, all processes are kept under control by means of Standard Operating Procedures (SOPs) describing activities such as staff training, instrument/equipment management and environment qualification.

All activities aimed at the assurance and continuous improvement of tissue collection, processing and distribution services are accredited by the National Transplant Centre and follow the ISO 9001:2015 standard.

FBTV is on the list of Tissue Banks certified by the National Transplant Centre

 

Certifications

FBTV is accredited by the National Transplant Centre (with biennial renewal) for the following processes:

  • Harvesting of cardiac, vascular, musculoskeletal, placental and skin tissue
    Processing and storage of cardiac, vascular, musculoskeletal and placental tissue
  • Distribution of cardiac, vascular, musculoskeletal and amniotic membrane tissue
  • FBTV has an active Quality Management System compliant with UNI EN ISO 9001:2015 certified by Certiquality, certificate no. 18938, for the following activities
  • Harvesting from living tissue, cadaver retrieval, processing, storage, validation and distribution of homograft tissues for transplantation purposes
  • Design and delivery of training and communication events
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