Annex 5

(Art. 29 para. 3 and 5, 30 para. 1, 32 para. 2)

Donor suitability, test procedures and information about donating blood

1 Evaluation of donor suitability

Recommendation R (95) of the Council of Europe of 12 October 1995¹(incl. Appendices) on the Preparation, Use and Quality Assurance of Blood Components.

2 Test procedure requirements

2.1 An unmixed sample from each blood donation must be tested for HIV 1 and 2, the hepatitis B virus (HBV), the hepatitis C virus (HCV) and Treponema pallidum.

2.2 Testing must include the determination of:

1. HIV 1 and 2 antibodies (anti-HIV 1+2 antibodies);
2. hepatitis B virus surface antigen (HBsAg) or antibodies against the hepatitis B virus core antigen (anti-HBc antibodies);
3. hepatitis C antibodies (anti-HCV antibodies);
4. Treponema pallidum antibodies;
5. HI virus (HIV 1): using an appropriate nucleic acid amplification technique;
6. hepatitis B virus (HBV): using an appropriate nucleic acid amplification technique;
7. hepatitis C virus (HCV): using an appropriate nucleic acid amplification technique.

2.3 Testing of autologous blood donations need only comprise the tests listed in number 2.2 letters a–d.

2.4 For plasma intended for fractionation, at least the tests listed in number 2.2 letters a–c must be performed.

2.5 The ABO blood group and the Rhesus D antigen expression must be determined for each blood donation, except for plasma intended for fractionation.

2.6 Additional tests may be required for specific components, donors or epidemiological situations.

3 Regulations concerning information

3.1 The information that must be given to potential donors of blood and labile blood products is specified in Recommendation R (95) of the Council of Europe of 12 October 1995 (incl. Appendices) on the Preparation, Use and Quality Assurance of Blood Components.

3.2 The information that must be obtained from donors for every donation must contain the following details in particular:

1. the personal details of the donor that permit unique identification with no danger of a mix-up, and contact details (donor identification);
2. the donor's state of health and previous diseases, in particular the factors that can help to identify and exclude persons whose donation could pose a risk to themselves or a risk of transmitting a disease to others;
3. the donor’s signature on the donor questionnaire;
4. the signature of the person specified in number 3.3.

3.3 The donor’s state of health and previous diseases must be recorded by a qualified healthcare professional by means of a questionnaire and a personal interview.

3.4 In signing the questionnaire, the donor confirms that he or she:

a. has read and understood the information provided;

b. has had the opportunity to ask questions;

c. has received satisfactory answers to any questions asked;

d. having been informed about the process, has consented to the donation being continued;

e. in the case of an autologous blood donation, has been informed that the donated blood or blood components may not be sufficient for the planned transfusion; and

f. has provided all information to the best of their knowledge and in good faith.