Regulatory compliance

History of regulatory compliance

The tissue banks that joined up to form NHS Blood and Transplant (NHSBT) Tissue and Eye 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.

1993 – first set of UK tissue banking standards

The British Association of Tissue Banking brought together tissue banking professionals across the UK and Eire to develop the first set of UK tissue banking standards.

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. 

2001 - voluntary 'Code of Practice for Tissue Banks'

This Department of Health initiative was developed by a working group, which included professionals from Tissue and Eye Services. We 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.

Mid 2000s – European legislation

Working with the Department of Health as part of a policy collaborative, we supported the development of the European legislation. This was to supersede the voluntary Code of Practice. The new legislation was directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004. Plus 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. Tissue and Eye 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. The Human Tissue Authority has issued Codes of Practice which detail recommendations in these areas.

Consent process

We have been instrumental in the development of consent processes that meet all legal and regulatory requirements. These processes are reviewed and endorsed:

• The Human Tissue Authority 
• Trent Research Ethics Committee
• UK Blood Services Tissue Donor Selection Guidelines 

All our teams that deal with consent, donor selection, donation, processing and supply complete a thorough training programme and assessment of competence.