Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance) (c. 33)

ANNEX II U.K. INFORMATION REQUIREMENTS (as referred to in Articles 2 and 3)

PART B U.K. Information to be obtained from donors by blood establishments at every donation

1. Identification of the donor U.K.

Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.

2. Health and medical history of the donor U.K.

Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified healthcare professional, that includes relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or health risks to themselves.

3. Signature of the donor U.K.

Signature of the donor, on the donor questionnaire, countersigned by the health care staff member responsible for obtaining the health history confirming that the donor has:

(a)

read and understood the educational materials provided;

(b)

had an opportunity to ask questions;

(c)

been provided with satisfactory responses to any questions asked;

(d)

given informed consent to proceed with the donation process;

(e)

been informed, in the case of autologous donations, that the donated blood and blood components may not be sufficient for the intended transfusion requirements; and

(f)

acknowledged that all the information provided by the donor is true to the best of his/her knowledge.