Quality and safety standards for human blood and blood components
The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order, in particular, to prevent the transmission of diseases. This Directive lays down high standards of quality and safety of human blood and blood components throughout the Community. The objective is to introduce a comprehensive package of binding rules applicable throughout the whole blood transfusion chain.
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 [See amending acts].
The purpose of this Directive is to set standards of quality and safety for blood * and blood components * throughout the blood transfusion chain. To this end, it applies to the collection and testing of human blood and blood components, irrespective of their final destination. It also applies to the processing, storage and distribution * of human blood and blood components intended for transfusion.
Obligations incumbent upon the authorities of the Member States
With regard to the licensing of blood establishments, Member States shall ensure that activities relating to the collection and testing of human blood and blood components are undertaken only by the blood establishments * which have been designated, authorised, accredited or licensed by the competent authority for that purpose.
All the information to be provided by blood establishments to the competent authority for the purposes of designation, authorisation, accreditation or licensing is specified in Annex I. This includes general information (identification of the blood establishment, qualifications and contact details of responsible persons, etc.) and a description of the quality system (quality manual, qualifications of personnel, hygiene provisions, details of procedures for assessment of donors, etc.).
The competent authority must organise inspections * and appropriate control measures in blood establishments at least once every two years. It must also organise appropriate measures in the event of any serious adverse event * or reaction or suspicion thereof.
Blood establishments must designate a person responsible for:
- ensuring that every unit of blood or of blood components has been collected and tested and, when intended for transfusion, has been prepared, stored and distributed in compliance with the laws in force in the Member State;
- communicating to the competent authority the information necessary for the designation, authorisation, accreditation or licensing procedure;
- implementing the requirements relating to quality management in blood establishments (cf. below).
These various tasks may be delegated to other persons who possess the necessary qualifications and experience.
The Directive stipulates minimum conditions of qualification for the person responsible for the blood establishment (university-level qualification in the field of medical or biological sciences and at least two years' post-graduate practical experience).
The personnel of the establishment must also possess the necessary qualifications and receive relevant and regular training.
A quality system based on the principles of good practice must be introduced by each blood establishment and hospital blood banks *. The Commission is responsible for establishing the Community standards and specifications relating to this system.
With regard to documentation and record-keeping, the blood establishments must keep the following up to date:
- documentation on operational procedures, guidelines, training and reference manuals, and reporting forms;
- records of the information required in Annexes II (report concerning the preceding year's activity) and IV (basic testing requirements for whole blood and plasma donations).
The competent authority must keep records of applications made by establishments for accreditation, provisions relating to existing establishments and notifications of any serious adverse reactions or events.
The traceability of blood and blood components, from donor to recipient and vice versa, must be guaranteed. In order to ensure full traceability, blood establishments and hospital blood banks must implement a system permitting unmistakable identification of each single blood donation and each unit of blood and components thereof.
A system permitting an equivalent level of traceability must be operated with regard to blood and blood components imported from third countries.
Product labelling must match the requirements listed in Annex III.
Any serious adverse events must be notified to the competent authority. Blood establishments and hospital blood banks must have in place a procedure for the efficient withdrawal from distribution of blood or blood components associated with a serious adverse event.
Conditions relating to donations and donors in order to ensure the quality and safety of blood and blood components
Donors must be provided with certain information when giving blood. This includes information on the characteristics of blood and blood products, and an undertaking by the blood collection centre to contact the donor if the results of the tests reveal any form of pathology.
Certain information must be obtained from donors, for example their identification, their state of health and medical history, and a signature confirming that the donor has read and understood the information provided.
The donor is subject to an evaluation procedure and must satisfy the criteria concerning physical suitability, such as age, and donation criteria, such as the time interval between donations. Permanent deferral criteria are also drawn up in order to protect both the donor and the recipient (for example in case of diseases that could place either the donor or the recipient in danger).
An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components.
Measures must be taken to encourage voluntary and unpaid blood donations, with a view to ensuring that blood and blood components are as far as possible provided from such donations.
Each donation of blood or blood components must undergo certain tests (listed in Annex IV). The same applies to blood or blood components imported into the Community.
Data protection and confidentiality
All data, including genetic information, must be rendered anonymous so that the donor is no longer identifiable.
Community code relating to medicinal products for human use
This Directive amends the Community code relating to medicinal products for human use in order to ensure that the safety and quality standards are the same whatever the intended purpose of blood or blood components, including their use as raw materials in the production of medicinal products.
The purpose of this Directive is to set standards of quality and safety for blood and blood components throughout the blood transfusion chain in the European Union (EU). It is a response not only to the need to protect public health but also to the need to ensure that the internal market functions properly by facilitating the movement of these products within the EU.
|Act||Entry into force - Date of expiry||Deadline for transposition in the Member States||Official Journal|
OJ L 33 of 8.2.2003
|Amending Act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 596/2009
OJ L 188 of 18.7.2009