S.L. 483.1 Art. 4Duties of establishments.

An establishment shall -

(a) ensure that the personnel directly involved in the procurement, processing, preservation, storage and distribution of tissues and cells are qualified to perform such tasks and are provided with timely, relevant and regularly updated training;

(b) ensure that all donations of human tissues and cells are subjected to tests in accordance with the requirements referred to in these regulations and any schedules and any amendments thereto and that the selection and acceptance of tissues and cells comply with the requirements referred to in these regulations and any schedules and any amendments thereto;

(c) ensure that human tissue and cells and associated documentation comply with the requirements referred to in these regulations and any schedules and any amendments thereto;

(d) verify and record the fact that the packaging of human tissue and cells received complies with the requirements referred to in these regulations and any schedules and any amendments thereto;

(e) discard all tissues and cells that do not comply with those requirements;

(f) document the acceptance or rejection of received tissues or cells;

(g) ensure that human tissues and cells are correctly identified at all times by assigning an identifying code to each delivery or batch of tissues or cells in accordance with regulation 6;

(h) hold tissue and cells in quarantine until such time as the requirements relating to donor testing and information have been met in accordance with article 15 of the Act;

(i) maintain documentation on operational procedures, guidelines, training and reference manuals and reporting forms so that they are readily available for inspection;

(j) include in their standard operating procedures all processes that affect quality and safety and shall ensure that they are carried out under controlled conditions;

(k) ensure that the equipment used, the working environment and process design, validation and control conditions are in compliance with the requirements referred to in these regulations and any schedules and any amendments thereto;

(l) ensure that any modifications to the processes used in the preparation of tissues and cells shall also meet the criteria laid down in the preceeding paragraph;

(m) include in their standard operating procedures special provisions for the handling of tissues and cells to be discarded, in order to prevent the contamination of other tissues or cells, the processing environment or personnel;

(n) ensure that all procedures associated with the storage of tissues and cells are documented in the standard operating procedures and that the storage conditions comply with the requirements referred to in these regulations and any schedules and any amendments thereto;

(o) ensure that all storage processes are carried out under controlled conditions;

(p) establish and apply procedures for the control of packaging and storage areas, in order to prevent any situation arising that might adversely affect the functioning or integrity of tissues and cells;

(q) not to distribute processed tissues and cells until all the requirements laid down in these regulations and any schedules and any amendments thereto have been met;

(r) have agreements and procedures in place to ensure that, in the event of termination of activities for whatever reason, stored tissues and cells shall be transferred to other tissue establishment or establishments licensed by the Authority;

(s) ensure that labelling and documentation and packaging conform to the requirements set by these regulations and any schedules and any amendments thereto; and

(t) ensure that the quality of tissues and cells during distribution and that the distribution conditions comply with the requirements set by these regulations and any schedules and any amendments thereto.