Euro GTP Guidance - Euro GTPs

8. In addition, in the case of a deceased donor, and in the case of a living donor when
justified, a physical examination of the body must be performed to detect any signs that may
be sufficient in themselves to exclude the donor or which must be assessed in the light of the
donor’s medical and personal history.
9. The complete donor records must be reviewed and assessed for suitability and signed by a
qualified health professional. 33
10. The donor selection criteria should be based on the risk analysis associated with the
properties and use of tissues and cells. Physical examination, medical history and social
behaviour, biological testing, post-mortem examination (for deceased donors) and other
appropriate investigations provide the information to assess the presence of such risks.
11. The donor selection criteria should take into account those donor aspects that influence
the safety of the donor and the safety and quality of a specific tissue.
12. Tissue specific contra-indications for donation have to be determined by the responsible
person of the TE, based on the risk assessment linked to the given disorder.
13. The TE should have a procedure in place to evaluate the consequence for donor selection
of emerging (infectious) diseases or advancing medical insights. Evaluations have to be
documented.
14. An authorised person must collect and record the donor’s relevant medical and
behavioural information according to the requirements.
15. In order to acquire the appropriate information, different relevant sources must be used,
including at least an interview with the donor for living donors, and for deceased donors an
interview with a person who knew the donor well. Furthermore, the following sources when
appropriate:
a) Medical records of the donor;
b) Interview with the treating physician;
c) Interview with the general practitioner;
d) Autopsy report when applicable;
e) Results of laboratory or imaging investigations;
f) Medical information of the mother in case of a newborn donor.
16. ‘The health professional responsible for obtaining the health history must ensure that the
donor or other relevant party has:
a. understood the information provided;
b. had an opportunity to ask questions and been provided with satisfactory
responses
33 Commission Directive 2006/17/EC (Annex IV)
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