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The Blood Safety and Quality Regulations 2005

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This is the original version (as it was originally made).

Service of notices relating to hospital blood banks

This section has no associated Explanatory Memorandum

11.—(1) If the Secretary of State is of the opinion that—

(a)the person responsible for management of a hospital blood bank has failed, in any material respect, to comply with the requirements of these regulations; or

(b)the testing, storage or distribution of blood or blood components by the hospital blood bank is such that any blood or blood components cannot be safely administered for transfusion; or

(c)the information given by the person responsible for management of a hospital blood bank pursuant to regulation 10 was false or incomplete in any material respect,

he may serve a notice on the person responsible for management of the hospital bank requiring that the hospital ceases to conduct any of the activities specified in the notice, or refrains from administering to patients any blood or blood components specified in the notice, until the requirements of paragraph (4) are met.

(2) Subject to paragraph (3), any notice served by the Secretary of State pursuant to paragraph (1) shall specify the date from which the prohibition specified in the notice shall take effect, which shall be not less than 7 days from the date on which the notice is served.

(3) Where the Secretary of State considers that it is necessary in the interests of safety, he may specify in the notice that the prohibition takes immediate effect.

(4) The requirements of this paragraph are, as may be applicable in each case, that—

(a)that the person responsible for management of the hospital blood bank is no longer in breach of the requirements of these regulations;

(b)that the hospital blood bank is able to show that the activity or product referred to in the notice given pursuant to paragraph (1)(b) may be safely carried out or, as the case may be, administered; or

(c)that all necessary information has been supplied to the Secretary of State.

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