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The Blood Safety and Quality Regulations 2005

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Hospital blood bank requirements

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9.—(1) The person responsible for the management of a hospital blood bank shall—

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

(b)establish and maintain a quality system for the hospital blood bank which is based on the principles of good practice;

(c)ensure that all processes referred to in Part 4 of the Schedule which are applicable to activities carried out by the hospital blood bank, are validated;

(d)maintain documentation on operational procedures, guidelines, training and reference manuals and reporting forms so that they are readily available for inspection under regulation 15;

(e)maintain, for not less than 30 years, the data needed to ensure full traceability of blood and blood components, from the point of receipt of the blood or blood component by the hospital blood bank;

(f)notify the Secretary of State of—

(i)any serious adverse events related to the testing, storage and distribution of blood and blood components by the hospital blood bank 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 issued for transfusion by the hospital blood bank;

(g)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 (f); and

(h)ensure that the storage, transport and distribution conditions of blood and blood components by the hospital blood bank comply with the requirements of Part 4 of the Schedule.

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