Tissue Services

Quality and safety are synonymous within Tissue Services. A quality graft is a safe graft and patient safety is our paramount concern.

Our approach has always been to embed quality into our policies, procedures and culture.

This can be demonstrated throughout our processes:

1) Regulatory compliance

Tissue Services was amongst the first tissue banks in the UK to be inspected by the MHRA (Medicines and Healthcare Products Regulatory Agency) to the Department of Health's voluntary Code of Practice for Tissue Banks. This has been superseded by the Human Tissue Act and Tissue Services is licensed by the HTA (Human Tissue Authority).

2) Good Manufacturing Practice (GMP)

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.

3) Independent QA Release

All tissue batch records are checked by both a Tissue Bank Manager and an independent Quality Assurance Manager to ensure that all tissues are safe and efficacious.

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.

4) Training

All Tissue Services personnel undergo rigorous, detailed training programmes and are assessed to ensure they are competent prior to undertaking their duties.

5) New Product Development

Prior to the implementation or introduction of a novel processing method or tissue the processes are validated to ensure they are effective. 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.

6) Traceability

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.

7) State of the Art Facility

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.

8) Continuous Improvement

The Tissue Bank is audited regularly by the NHS Blood and Transplant team of expert independent auditors. This ensures continued compliance and also drives continuous improvement.

9) Multidisciplinary Team

All aspects of the process (both clinical and scientific) are controlled by Tissue Services to ensure that all tissue grafts are quality assured.