Wednesday, June 28, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.3. DONOR SCREENING

A.3. DONOR SCREENING

1. Both generic and specific GTPs should include requirements related to donor selection and evaluation, risk assessment, validation methodologies, documentation, premises, personnel and quality management.

2. The major objective of the chapter on the donor screening process is to protect the final tissue recipient.  Safety and quality of the human tissue depends, to a large extent, on the ability to identify true positive risks and avoid false positive risks.

3. According to EU Directive 2006/17/EC, Articles 3 and 4 ‘Selection criteria for donors are based on an analysis of the risks related to the application of the specific cells/tissues.  Indicators of these risks should be identified by physical examination, review of the medical and behavioural history, biological testing, post-mortem examination (for deceased donors) and any other appropriate investigation.’  Outlines for physical examination are described elsewhere in this Guide, whereas the other criteria could be defined as the process of donor screening.  The purpose of screening a donor is to collect information, to assess the data on critical points of safety, quality and unique identification, and to evaluate this information in relation to relevant aspects of the tissue, in order to determine whether or not to release tissues for transplantation purposes

4. This chapter aims to provide tools to carry out the screening test in the best way so as to ensure the quality of the tissue and the safety of transplant recipients.  The scope of this chapter covers the steps between donor detection and donor release for further processing.

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