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This is the original version (as it was originally made).

Disclosure of information by blood establishments and hospital blood banks

This section has no associated Explanatory Memorandum

14.—(1) A blood establishment and the person responsible for management of a hospital blood bank shall ensure that all information which is collected for the purposes of these Regulations is held securely so that it is—

(a)available for the purpose of, tracing donations;

(b)not disclosed except—

(i)in accordance with one or more of the requirements of paragraph (2), or

(ii)where they have been rendered anonymous so that donors are no longer identifiable;

(c)subject to safeguards against unauthorised additions, deletions or modifications.

(2) The requirements of this paragraph are—

(a)the disclosure is made in accordance with an order of a court or is otherwise required by law;

(b)the disclosure is to an inspector appointed by the Secretary of State in accordance with regulation 15(10); or

(c)the disclosure is for the purpose of tracing a donation from donor to recipient or recipient to donor.

(3) Where a disclosure is made to an inspector pursuant to paragraph (2)(b), the inspector shall not further disclose the information received unless—

(a)the disclosure is made in accordance with an order of a court or is otherwise required by law;

(b)the disclosure is to another officer of the Secretary of State where this is necessary for the proper performance of the inspector or officer’s duties; or

(c)the information has been rendered anonymous so that that donors are no longer identifiable.

(4) Where a disclosure is made by an inspector to another officer of the Secretary of State pursuant to paragraph (3), that person shall not further disclose the information he receives other than in accordance with the requirements of that paragraph.

(5) The responsible person of the blood establishment and the person responsible for management of the hospital blood bank shall ensure that they put in place a procedure to ensure that any discrepancies relating to data which are brought to their attention are resolved without delay.

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