S.L. 483.6 Art. 4Framework for quality and safety.

(1) Procurement organisations and transplantation centres shall be bound to have in place a framework for quality and safety covering all stages of the chain from donation to transplantation or disposal.

(2) The framework shall provide for the adoption and implementation of operating procedures for:

(a) the verification of donor identity;

(b) the verification of the details of the donor’s or the donor’s family’s consent, authorisation or absence of any objection, in accordance with the national rules that apply where donation and procurement take place;

(c) the verification of the completion of the organ and donor characterisation in accordance with regulation 7 and the Schedule;

(d) the procurement, preservation, packaging and labelling of organs in accordance with regulations 5, 6 and 8;

(e) the transportation of organs in accordance with regulation 8;

(f) ensuring traceability, in accordance with regulation 10, guaranteeing compliance with European Union and national legal provisions on the protection of personal data and confidentiality;

(g) the accurate, rapid and verifiable reporting of serious adverse events and reactions in accordance with regulation 11(1);

(h) the management of serious adverse events and reactions in accordance with regulation 11(2).

(3) Procurement organisations and transplant centres shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal are suitably qualified or trained and competent, and shall develop specific training programmes for such personnel.