Suitability of blood donors

This Recommendation is intended to boost confidence in the safety of the blood transfusion chain and to enhance the European Community's self-sufficiency in blood supplies.

ACT

Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community [Official Journal L 203 of 21.7.1998].

SUMMARY

Awareness

The Member States ought to make donors aware of:

• the benefits to patients of blood and plasma donations;
• the risk of infectious diseases being transmitted by blood and blood products, and the resultant need for a medical history, a physical examination and the testing of donations;
• the reasons why they should not provide donations, in the interests of both their own health and the safety of recipients;
• the possibility of asking questions and of withdrawing from the donation process at any time.

Information given to donors

Donors are given an assurance that they will be contacted by the blood collection centre if test results show evidence of any pathology.

Donors are informed of the measures taken to ensure the confidentiality of any information relating to their health and their donation. They have the option of requesting that the medical staff should not use their donation.

Information provided by donors

Donors should provide to the blood and plasma collection establishment the following details:

• their identity, attested by a valid official document;
• information on their health and medical history, including any behavioural characteristics that may affect the quality of the donation, by way of a written questionnaire and an interview with a trained medical staff member;
• their signature on the said questionnaire, alongside that of the medical staff member conducting the interview; their agreement that their donation(s) may be used and their written consent confirming that they wish to continue with the donation process.

Identification/registration system

The Member States should ensure that an identification/registration system is set up for the purpose of:

• identifying every collection establishment;
• identifying prospective donors in such a way that verification is possible each time a donation is made;
• future traceability of donations through the keeping of records on donors and prospective donors, ensuring unique identification with all the necessary guarantees of confidentiality;
• allowing the inclusion of information relating to adverse donor reaction to a donation and reasons for preventing an individual from making a donation, whether temporarily or permanently, whilst ensuring confidentiality.

Donor suitability

The criteria for acceptance of donors should be clearly indicated in every donation centre and explained to the donors.

The Member States must ensure that a donation will not adversely affect the health of a future recipient or of the donor. A prospective donor's suitability must be determined at each donation session, with steps being taken to prohibit or phase out the use of "replacement donors". Moreover, a responsible physician is required to give his/her written authorisation at the final stage of determining the suitability of a prospective donor whose eligibility is questionable.

The Member States must take steps to exclude permanently or temporarily from the donation process persons who display any of the conditions and characteristics listed in sections B and C of Annex II.

The exclusion of any prospective donor, whether permanent or temporary, must be recorded in a file, indicating the reasons.

Confidentiality

The Member States must ensure the confidentiality and security of sensitive medical information about prospective donors. They are required to put in place procedures for resolving data discrepancies and to prevent the unauthorised disclosure of information, while ensuring the traceability of donations.

Protection of donors' health

Annex III of the Recommendation sets out common standards for the protection of donors' health, particularly as regards:

• the maximum volumes of blood and plasma to be collected during a single donation and over a 12-month period;
• the minimum time interval between donations.

Medical attention must be made available to the donor if the donation gives rise to an adverse event.

The Member States should ensure that a sample of every donation is tested for diseases transmissible by blood and that re-testing is carried out on blood samples found to be reactive in an initial screening test.

Encouragement of voluntary donation

The Member States should take all the necessary measures to encourage the voluntary and unpaid donation of blood and plasma.

RELATED ACTS

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Directive 2001/83/EC [Official Journal L 33 of 08.02.2003]. This Directive lays down high standards of quality and safety for human blood and blood components throughout the Community, with the aim of putting in place a full set of binding rules across the entire "transfusion chain".

Last updated: 26.05.2006