ANNEX IIU.K.INFORMATION REQUIREMENTS (as referred to in Articles 2 and 3)
PART AU.K.Information to be provided to prospective donors of blood or blood components
1.Accurate educational materials, which are understandable for members of the general public, about the essential nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, and the important benefits to patients.U.K.
2.For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history, and the testing of donations and the significance of ‘informed consent’.U.K.
For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are not to donate blood or blood components if there could be a risk for the recipient.
For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take place in the presence of a health risk to the individual whether as donor or recipient of the autologous blood or blood components.
3.Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of information concerning the donor's health, and of the results of the tests performed.U.K.
4.The reasons why individuals are not to make donations which may be detrimental to their health.U.K.
5.Specific information on the nature of the procedures involved either in the allogeneic or autologous donation process and their respective associated risks. For autologous donations, the possibility that the autologous blood and blood components may not suffice for the intended transfusion requirements.U.K.
6.Information on the option for donors to change their mind about donating prior to proceeding further, or the possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrassment or discomfort.U.K.
7.The reasons why it is important that donors inform the blood establishment of any subsequent event that may render any prior donation unsuitable for transfusion.U.K.
8.Information on the responsibility of the blood establishment to inform the donor, through an appropriate mechanism, if test results show any abnormality of significance to the donor's health.U.K.
9.Information why unused autologous blood and blood components will be discarded and not transfused to other patients.U.K.
10.Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmissible microbiologic agents, will result in donor deferral and destruction of the collected unit.U.K.
11.Information on the opportunity for donors to ask questions at any time.U.K.
PART BU.K.Information to be obtained from donors by blood establishments at every donation
1.Identification of the donorU.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 donorU.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 donorU.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.