Guide to safety and quality assurance for organs, tissues and cells (2002)

The non-commercialisation of substances of human origin is one of the basic principles supported by the Council of Europe. The safety and dignity of the donor and the recipient are the ethical concerns followed by the European Health Committee. To this end a Group of Experts was entrusted to prepare this guide, which includes standards for procurement, preservation, processing and distribution.
The legal provisions which should be complied with in the area of the transplantation of organs, tissues and cells are enacted in the additional protocol to the Convention on Human Rights and Biomedicine. The protocol is appended in its entirety to this guide.

The Guide to safety and quality assurance will be of interest to health professionals working in transplantation centres, organ, tissues and cell exchange organisations, legislators and all those working in the field of transplantation. This guide will be regularly updated, in line with the latest technical progress.

Contents

Chapter 1 - Introduction
Scope
Benefits of transplantation
Risks of transplantation
Ethical issues
Quality assurance
Organisational issues
Chapter 2 - Selection of donors
General requirements
Cadaveric donors
Living donors of organs, tissues and cells
Chapter 3 - Organ retrieval and preservation
Living donation
Cadaveric donation
Chapter 4 - Tissue and cell procurement
Types of tissues and cells
Living-donor tissue retrieval
Cadaveric donor tissue retrieval
Donor identification
Donor identification number
Labelling and packaging
Retrieval documentation
Storage and transportation to processing facility
Haematopoietic Progenitor Cells (HPC): specific issues
Chapter 5 - Tissue and cell banking
General organisational requirements of a tissue or cell bank
Facilities and equipment
Tissue and cell processing, preservation and storage
Release of tissue or cells
Tracking
Transportation
Return into inventory
Exceptional release
Recipient adverse events and non-conformances
Hospital tissue and cell storage and distribution
Chapter 6 - Transplantation practices
Organisational issues
Pre-transplant period
Peri-transplant period
Post-transplant period
Use of organs, tissues and cells for purposes other than transplantation
Appendices
Appendix 1: Participants
Appendix 2: List of relevant standards/guidelines
Appendix 3: Definitions
Appendix 4: Additional protocol to the Convention on Human Rights and Biomedicine, on transplantation of organs and tissues of human origin