Tissue banking: general principles
Regulatory environment in the UK
The whole process of tissue banking is now covered by legislation. The EU Directive 2004/23 (March 2004) has been transposed into UK law. This Directive lays down standards of quality and safety for all aspects of banking of human tissues and cells intended for human applications. In addition the Human Tissue Act 2004 applies throughout the UK with the exception of Scotland, where the Human Tissue (Scotland) Act 2006 applies.
All tissue establishments need to be licensed by the competent Authority which in the case of the UK is the Human Tissue Authority.
Every tissue establishment shall designate a responsible person (Designated Individual) who shall be responsible for ensuring that all activities relating to human tissues and cells intended for human application are in accordance with the laws in force in the UK (Article 17).
It is therefore the responsibility of the Designated Individual to ensure that all the requirements of the HTA are met in a timely and comprehensive manner.
Data protection and confidentiality
Living donors and families of deceased donors must be told that information relating to the donation will be stored in accordance with the Data Protection Act (DPA)1998 and may be shared with relevant health professionals.
Tissue establishments shall take the necessary measures to ensure that all data, collated within the scope of all their banking activities and to which third parties have access, have been rendered anonymous so that neither donor nor recipients remain identifiable.
Reference documents for tissue banking and haemopoietic progenitor cells
The advice contained in these Guidelines is believed to represent acceptable practice at the time of printing. It is policy to revise these Guidelines as new developments occur. However, it may not be possible to do so at the time of such change and the Guidelines should therefore be used with due regard to current acceptable practice.
The guidelines in this section apply to tissue banking activities within the Blood Transfusion Services of the UK. They must be read in conjunction with the other sections of the guidelines including those that apply to care and selection of blood donors, quality systems, quality assurance and to testing of donors.
Reference should be made to the current version Joint UKBTS/NIBSC Professional Advisory Committee's Donor Selection Guidelines available at www.transfusionguidelines.org.uk.
Note should also be made of various UK legal statutes and relevant documents which apply to tissue banking, and documents from the Council of Europe and the European Directives. These include the following:
UK legal statutes and documents relevant to tissue banking
Note: this list is current for 2007.
Department of Health. A Code of Practice for Tissue Banks: Providing Tissues of Human Origin for Therapeutic Purposes. DoH, February 2001. ISBN 1-84182-329-5.
Department of Health. Decontamination of Medical Devices. HSC 2000/032, 18 October 2000.
Department of Health. Guidance on the Microbiological Safety of Human Tissues and Organs used in Transplantation. Advisory Committee on Microbiological Safety of Blood and Tissues for Transplantation, DoH, August 2000. www.advisorybodies.doh.gov.uk/acmbtt.
Department of Health. Variant Creutzfeldt-Jakob Disease (vCJD): Minimising the Risk of Transmission. HSC 1999/178, 13 August 1999.
Department of Health. Controls Assurance in Infection Control: Decontamination of Medical Devices. HSC 1999/179, 13 August 1999.
Medical Research Council. Operational and Ethical Guidelines for Collections of Human Tissue and Biological Samples for Use in Research. Report of the Medical Research Council Working Group, November 1999.
Report of the Working Party of the Royal College of Pathologists and the Institute of Biomedical Science. Third Edition (2005) The Retention and Storage of Pathological Records and Archives.
General Medical Council booklets (available at www.gmc-uk.org):
Confidentiality: Protecting and Providing Information: April 2004
Serious Communicable Diseases: October 1997 Good Medical Practice (Third Edition): May 2001
Seeking Patients' Consent: the Ethical Considerations: November 1998
Research: the Role and Responsibility of Doctors: February 2002
Department of Health, A Code of Practice for the Diagnosis of Brain Stem Death Including Guidelines for the Identification and Management of Potential Organ and Tissue Donors. Department of Health, March 1998 available at www.dh.gov.uk.
Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection. Advisory Committee on Dangerous Pathogens Spongiform Encephalopathy Advisory Committee. June 2003 available at www.dh.gov.uk.
Health Technical Memorandum (HTM) 2010 Sterilization www.nhsestates.gov.uk.
Health Technical Memorandum (HTM) 2030 Washer-Disinfectors www.nhsestates.gov.uk.
Health Technical Memorandum (HTM) 2031 Clean Steam for Sterilization
Data Protection Act 1998, ISBN 0-10-542998-8 available at www.hmso.gov.uk.
The Anatomy Act 1984 (Commencement) Order 1988, ISBN 0-11-086081-0 available at www.legislation.hmso.gov.uk.
Department of Health, The Caldicott Committee, Report on the Review of Patient-Identifiable Information. December 1997 available at www.dh.gov.uk.
Medicines and Healthcare products Regulatory Agency (2007) Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Pharmaceutical Press, ISBN 978-0-85369-719-0.
Nuffield Council of Bioethics (1995) Human Tissues: Ethical and Legal Issues available at www.nuffieldbioethics.org.
Human Organ Transplants Act 1989 (Scotland), ISBN 0-10-543189-3 available at www.opsi.gov.uk.
Human Tissue Act 2004 (except Scotland), ISBN 0-10-543004-8 available at www.legislation.opsi.gov.uk.
Human Tissue (Scotland) Act 2006, ISBN 0-10-590094-X available at www.show.scot.nhs.uk.
Coroners Act 1988, ISBN 0-10-541388-7 available at www.opsi.gov.uk.
Department of Health, HSG (93)40: Protecting Health Care Workers and Patients from Hepatitis B and Addendum to HSG (93)40 available at www.dh.gov.uk.
Department of Health, Human Bodies, Human Choices the Law on Human Organs and Tissue in England and Wales a Consultation Report. July 2002 available at www.dh.gov.uk.
Department of Health, Human Bodies, Human Choices: Summary of the Responses to the Consultation Report. April 2003 available at www.dh.gov.uk.
Department of Health, Saving Lives, Valuing Donors: A Transplant Framework for England. July 2003 available at www.dh.gov.uk.
Joint UKBTS/NIBSC Professional Advisory Committee’s Position Statements "Consent to Tissue Donation" available at www.transfusionguidelines.org.uk.
Documents from the Council of Europe
Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 4IV. 1997, European Treaty Services/164 www.conventions.coe.int.
Solutions for Organ Preservation. European Pharmacopoeia, monograph No. 1264 (supplement 5).
Council of Europe (2007) 'Guide to safety and quality assurance for the transplantation of organs, tissues and cells, Third Edition'. ISBN 978-92-871-6037-9 available from Council of Europe publishing at www.coe.int.
European Union Directives
These are listed in Chapter 1.
Directive 2004/23/EC 'on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells’. OJ, L 102, 07.04.2004, p48.
Directive 2006/17/EC of 8 February 2006 'implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells’. OJ, 9.2.2006
Directive 2006/86/EC of 24 October 2006 'implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells’. OJ, 25.10.2006
These Directives became legally binding throughout the UK from April 2007.