Safety and quality
We work within a highly regulated environment and operate under a quality system
You’re in safe hands
Quality and safety are synonymous within Tissue and Eye Services. A quality graft is a safe graft and patient safety is our paramount concern. Our system ensures traceability of tissues from donor to recipient hospital and the highest standards of microbiology testing.
Our safety and quality processes
We were amongst the first tissue banks in the UK to be inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA). This has been superseded by the Human Tissue Act, and Tissue and Eye Services is licensed by the Human Tissue Authority (HTA). All our procedures comply with:
- The Human Tissue Act (2004)
- The HTA codes of practice
- The EU Cell and Tissue Directive
- EU Regulations and Guidance on Microbiological Safety of Human Organs
- Tissue and Cells used in Transplantation
- The Guidelines for the Blood Transfusion Service in the UK
All tissue donor selection and tissue retrieval, processing, storage and issue activities are controlled via the principles of GMP. This includes the control of processes, documents, personnel, change, facilities, consumables and the management of adverse events and incidents.
All tissue batch records are checked by a Tissue Bank Manager and an independent Quality Assurance Manager. Tissue release is controlled by the PULSE computer system which checks that all mandatory results are acceptable before enabling the transfer of tissue from quarantine to available for issue.
Our team undergo rigorous, detailed training programmes and are assessed to ensure they are competent prior to undertaking their duties.
Processes are validated to ensure they are effective prior to the implementation or introduction of a novel processing method or tissue. Any change to a process is also validated and has to be controlled via the change control process. New tissue grafts are validated and introduced via the GMP Tissue Validation and Development Laboratory and the Technology Centre.
Tissue is traced from donor to final product via bar code labelling to the ISBT 128 system. This ensures anonymity for the donor whilst maintaining links to all testing and processing records. All equipment and consumables used in tissue donation and processing are recorded.
The Tissue Bank was designed and purpose built in collaboration with experts to ensure compliance with GMP. This world class facility has a suite of clean rooms to ensure all products are processed to the highest possible quality standards.
The Tissue Bank is audited regularly by NHS Blood and Transplant's team of expert independent auditors. This ensures continued compliance and also drives continuous improvement.
All aspects of the process (both clinical and scientific) are controlled by us to ensure that all tissue grafts are quality assured.