Regulatory Compliance

The tissue banks that joined up to form NHS Blood and Transplant (NHSBT) Tissue Services were greatly influential in the development of the UK standards that exist today. These standards have been aligned to other international benchmarks e.g. American Association of Tissue Banks and European Association of Tissue Banks.

The British Association of Tissue Banking in 1993 under the first president John Kearney (the then Director of the Yorkshire Regional Tissue Bank – (YRTB) which later joined NHSBT) brought together professionals in the field of tissue banking across the UK and Eire to develop the first set of UK tissue banking standards. YRTB also held ISO certification. Over the same period, the tissue banks already within the UK Blood Services further developed these standards in the 'Guidelines for Blood Transfusion Services in the UK'. The current version of these is available at www.transfusionguidelines.org.uk.

In 2001 the Department of Health voluntary 'Code of Practice for Tissue Banks' was developed by a working group including professionals from Tissue Services. NHSBT Tissue Services were inspected by the Medicines Control Agency (later to become the Medicines and Healthcare product Regulatory Authority) and became the first multi-tissue bank to be licensed under the scheme.

By again working with the Department of Health as part of a policy collaborative, Tissue Services also supported the development of the European legislation that was to supersede this voluntary scheme: Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004, and it's subsequent Commission Directives 2006/17/EC, 8 February 2006 and 2006/86/EC 24 October 2006.

In addition, The Human Tissue Act 2004, Human Tissue (Scotland) Act 2006 and associated Codes of Practice have also now been transposed into UK law, and Tissue Services hold licenses from the Human Tissue Authority to cover all these aspects. A major feature of the Human Tissue Act is that it makes consent the fundamental principle for the lawful removal, storage and use of human tissue, and the Human Tissue Authority have issued Codes of Practice which detail recommendations in these areas.

Tissue Services have been instrumental in the development of consent processes for NHSBT that meet all legal and regulatory requirements. These processes have been reviewed and endorsed by the Human Tissue Authority and Trent Research Ethics Committee. In addition Tissue Services procedures for the assessment and selection of donors meet all requirements. Tissue Services is represented on the UK Blood Services Tissue Donor Selection Guidelines writing group. These guidelines also include the requirements for occular tissue donation and are available online at www.transfusionguidelines.org.uk. All staff that undertake consent, donor selection, donation, processing and supply do so only after completion of a thorough training programme and successful assessment of competence.

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0845 607 6820

National Fax Line:
0845 607 6819

Tissue Services

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