Contents


Chapter 1 - Introduction
1.1. Introduction and scope
1.2. Benefits of transplantation
1.3. Risks of transplantation
1.4. Ethical issues
1.5. Quality management
1.6. Organisational issues

Chapter 2 - Quality management: principles for ensuring the quality of organs, tissues and cells
2.1. Introduction
2.2. General principles
2.3. Examples of quality management systems
2.4. Terminology
2.5. Quality management

Chapter 3 - Selection of donors
3.1. General requirements
3.2. Deceased donors
3.3. Living donors
3.4. Collection of surgical residues
3.5. Retesting of living donors of stored allogeneic material

Chapter 4 - Organ procurement and preservation
4.1. Deceased donors
4.2. Living donation
4.3 Organ preservation, packaging, transportation and traceability

Chapter 5 - Tissue and cell procurement
5.1. Procurement from deceased donors
5.2. Procurement from living donors
5.3. Unique donor identifier
5.4. Labelling and packaging
5.5. Procurement documentation
5.6. Storage and transportation to processing facility
5.7. Haematopoietic progenitor cells (HPC): specific issues

Chapter 6 - Tissue establishments
6.1. General organisational requirements of a tissue establishment (TE)
6.2. Facilities and equipment
6.3. Tissue and cell processing, preservation and storage
6.4. Release of tissues or cells
6.5. Distribution
6.6. Traceability
6.7 Transportation
6.8. Return into inventory
6.9. Exceptional release
6.10. Adverse reactions and events, and non-conformances
6.11. Hospital tissue and cell storage and distribution

Chapter 7 - Transplantation practices
7.1. Organisational issues
7.2. Pre-transplant period
7.3. Peri-transplant period
7.4. Post-transplant period
7.5. Use of organs, tissues and cells for purposes other than transplantation

Appendix 1 - Committee of Experts on Safety and Quality Assurance for Organs, Tissues and Cells (SP-SQA)
Appendix 2 - List of relevant standards/guidelines
Appendix 3 - Example of the evaluation of donor risk factors for transmissible diseases
Appendix 4 - Definitions
Appendix 5 - Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin
Addendum 2009 - Criteria for preventing the transmission of neoplastic diseases in organ donation