S.L. 483.6 Art. 7Transport of organs.

(1) (a) All procured organs and donors thereof shall be characterised before transplantation through the collection of the information set out in the Schedule.

(b) The information specified in Part A of the Schedule contains a set of minimum data which has to be collected for each donation. Information specified in Part B of the Schedule contains a set of complementary data to be collected in addition, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case.

(2) Notwithstanding the provisions of sub-regulation (1), if according to a risk-benefit analysis in a particular case, including in life-threatening emergencies, the expected benefits for the recipient outweigh the risks posed by incomplete data, an organ may be considered for transplantation even where not all of the minimum data specified in Part A of the Schedule are available.

(3) In order to meet the quality and safety requirements laid down in these regulations, the medical team shall endeavour to obtain all necessary information from living donors and for that purpose shall provide them with the information they need in order to understand the consequences of donation. In the case of deceased donation, where possible and appropriate, the medical team shall endeavour to obtain such information from relatives of the deceased donor or other persons. The medical team shall also endeavour to make all parties from whom information is requested aware of the importance of the swift transmission of that information.

(4) The tests required for organ and donor characterisation shall be carried out by laboratories with suitably qualified or trained and competent personnel and adequate facilities and equipment.

(5) Organisations, bodies and laboratories involved in organ and donor characterisation shall have appropriate operating procedures in place to ensure that the information on organ and donor characterisation reaches the transplantation centre in due time.

(6) Where organs are exchanged between Member States, the information on organ and donor characterisation, as specified in the Schedule, shall be transmitted to the other Member State with which the organ is exchanged.