S.L. 483.2 Art. 5Duties of blood establishments.

(1) A blood establishment shall -

(a) ensure that the personnel directly involved in the collection, testing, processing, storage and distribution of human blood and blood components for the blood establishment are qualified to perform those tasks and are provided with timely, relevant and regularly updated training;

(b) establish and maintain a quality system for blood establishments laid down in the Schedule IX;

(c) ensure that all testing and processes of the blood establishment which are referred to in Schedules V and VIII are validated;

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

(e) notify the Authority of -

(i) any serious adverse events related to the collection, testing, processing, storage and distribution of blood and blood components by the blood establishment which may have an influence on their quality and safety, and

(ii) any serious adverse reactions observed during or after transfusion which may be attributable to the quality or safety of blood or blood components collected, tested, processed, stored or distributed by the blood establishment; and

(f) establish and maintain a procedure, which is accurate, efficient and verifiable, for the withdrawal from distribution of blood or blood components associated with any notification referred to in paragraph (e).

(2) A blood establishment shall, in relation to the donation of blood -

(a) give all prospective donors of blood or blood components information in accordance with Part A of Schedule V;

(b) obtain from all persons who are willing to provide blood or blood components, information in accordance with Part B of Schedule V;

(c) put and keep in place procedures for the evaluation of donors;

(d) apply eligibility criteria for all donors of blood and blood components in accordance with Schedule VI;

(e) maintain records of the results of donor evaluations and report to donors any relevant abnormal findings from the evaluations;

(f) ensure that -

(i) an examination of the donor, including an interview, is carried out before any donation of blood or blood components,

(ii) a qualified health professional is responsible for giving to and gathering from donors the information which is necessary to assess their eligibility to donate, and

(iii) on the basis of that information, a qualified health professional assesses the eligibility of all donors to donate; and

(g) encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are, in so far as possible, provided from such donations.

(3) A blood establishment shall ensure that, in relation to the blood and blood components which it collects, processes, stores or distributes:

(a) each donation of blood and blood components, including blood and blood components which are imported into the European Community, is tested in conformity with the requirements listed in Schedule IV;

(b) the storage, transport and distribution conditions of blood and blood components comply with the requirements of Schedule VII; and

(c) quality and safety requirements for blood and blood components meet the standards specified in Schedule VIII.

(4) A blood establishment shall, in relation to the information required by Schedules II, IV, V and VI, maintain records, for a minimum period of fifteen years.

(5) As soon as practicable after the end of the reporting year, each blood establishment shall provide to the Authority a report specifying -

(a) the information referred to in sub-regulation (3) for that year; and

(b) details of the steps it has taken during that year to comply with the provisions of sub-regulation (2)(g).