S.L. 483.2 Art. 4Responsible person.

(1) A blood establishment shall designate a person who is responsible for the following tasks:

(a) ensuring that every unit of blood or blood component that has been collected or tested for any purpose has been collected and tested in accordance with the requirements of these regulations;

(b) ensuring that every unit of blood or blood components intended for transfusion has been processed, stored and distributed in accordance with the requirements of these regulations;

(c) providing information to the Authority relating to the licence of the blood establishment for the purposes of regulation 3; and

(d) the implementation in the blood establishment of the requirements of articles 10,11, 12, 13, 14 and 15 of the Act.

(2) A blood establishment shall not designate a person as a responsible person unless that person has -

(a) a diploma, certificate or other evidence of formal qualification in the field of medical or biological sciences awarded on completion of -

(i) a university course of study, or

(ii) a course recognised as an equivalent course by the Authority; and

(b) practical post-graduate experience in areas of work relevant to the responsibilities of the responsible person under these regulations for at least two years, in one or more establishments licenced in any Member State to undertake activities related to the collection and, or testing of blood and blood components, or to their preparation, storage and distribution.

(3) The responsible person may delegate any of the tasks specified in sub-regulation (1) to other persons who shall be qualified by training and experience to perform them.

(4) Blood establishments shall notify the Authority of the name of any persons to whom tasks have been delegated by the responsible person under sub-regulation (3), and the specific tasks which have been delegated to such persons.

(5) Where the responsible person or a person to whom tasks have been delegated under sub-regulation (3) is permanently or temporarily replaced, the blood establishment shall immediately provide the Authority with the name of the replacement, details of his qualifications and the date on which the replacement began his duties.

(6) If the Authority considers that the responsible person does not meet the requirements of sub-regulation (2), it may serve a notice to that effect on the blood establishment.

(7) If, within fourteen days of receiving a notice in accordance with sub-regulation (7), a blood establishment is not able to demonstrate to the reasonable satisfaction of the Authority that the responsible person does meet the requirements of sub-regulation (2), it shall, without delay -

(a) relieve him of the duties of responsible person in respect of the establishment;

(b) appoint a new responsible person in his place; and

(c) notify the Authority that it has appointed a new responsible person and provide details of the name and qualifications of the person appointed.