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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.

ACT

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].

SUMMARY

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.

Responsible person

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.

Quality management

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.

Haemovigilance *

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.

Background

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.

Key terms used in the act
  • Blood component: a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods (centrifugation, filtration and freezing).
  • Hospital blood bank: a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities.
  • Distribution: the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.
  • Blood establishment: any structure or body that is involved in any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion.
  • Haemovigilance: a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.
  • Serious adverse event: any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.
  • Inspection: formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.
  • Blood product: any therapeutic product derived from human blood or plasma.
  • Blood: whole blood collected from a donor and processed either for transfusion or for further manufacturing.
  • Autologous transfusion: a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used.

REFERENCES

ActEntry into force - Date of expiryDeadline for transposition in the Member StatesOfficial Journal

Directive 2002/98/EC

8.2.2003

8.2.2005

OJ L 33 of 8.2.2003

Amending Act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal

Regulation (EC) No 596/2009

7.8.2009

-

OJ L 188 of 18.7.2009

RELATED ACTS

Implementing measures

Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic [Official Journal L 288 of 4.11.2009].
This implementing Directive, applicable until 30 June 2009, gave Member States the possibility to derogate exceptionally and conditionally from certain eligibility criteria for blood donors in order to guarantee blood supply in the case of an Influenza A(H1N1) pandemic, whilst ensuring the health of blood and blood component donors and recipients is protected.

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments [Official Journal L 256 of 1.10.2005].
This implementing Directive lays down the specific technical requirements for a quality system for blood establishments.
Member States must ensure that the quality system in place in all blood establishments and hospital blood banks complies with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events [Official Journal L 256 of 1.10.2005].
This implementing Directive lays down the technical requirements to ensure traceability of blood and blood components from the donor to the recipient, and the procedures.
Member States must ensure that the systems and procedures for traceability and notification of serious adverse reactions in place at national level and in all blood establishments and hospital blood banks comply with the Community standards and specifications set out in the Annex to the Directive.

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 [Official Journal L 91 of 30.3.2004].
In application of Directive 2002/98/EC, this text provides more detailed information, criteria and requirements relating to donations and donors, storage, transport and distribution of blood and blood components and to the quality and safety of blood and blood components.

Implementation reports

Communication from the Commission of 19 January 2010 to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2002/98/EC 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 [COM(2010) 3 final – Not published in the Official Journal].
This Communication reports a satisfactory implementation of Directive 2002/98/EC. Member States have now successfully designated and set up their competent authorities, as well as inspection systems, control measures and haemovigilance systems.
However, Member States must pursue the finalisation of the accreditation/designation/authorisation/licensing process for all blood establishments.
The Commission encourages the good practice of collecting reports on blood establishments in the preceding year. These reports could be a valuable source of information for both regulators and citizens.

Report from the Commission of 19 June 2006 - First report on the application of the Blood Directive [COM(2006) 313 final – Not published in the Official Journal].
This report sets out the measures adopted by the Member States in application of the Blood Directive. It covers the 15 Member States which belonged to the EU on 31 December 2003.
The report points out that ten Member States adopted more stringent protective measures than those provided for in the Directive, particularly with regard to donor selection, biological control of donations and haemovigilance.
The document describes the application, at national level, of the Directive's provisions relating to:

  • the obligations of the competent national authorities, in particular those relating to inspection and control;
  • blood establishments and the obligation to designate a responsible person with at least the minimum qualifications;
  • quality management in each blood establishment;
  • haemovigilance;
  • the quality and safety of blood and blood components;
  • data protection.

Report from the Commission of 17 May 2006 on the promotion by Member States of voluntary unpaid blood donations [COM(2006) 217 final – Not published in the Official Journal].
This report summarises the measures taken by Member States to encourage voluntary unpaid donations (allowances, possibility of time off work, information campaigns, awareness programmes, etc.).
It also presents the measures the Commission intends to take in order to promote self-sufficiency in human blood and human plasma in the European Community. Such measures include:

  • a Europe-wide study to identify best practices with a view to developing a methodology and basic set of principles for awareness campaigns;
  • continuation of the discussion on self-sufficiency in the Community with an examination of the question of the optimal use of blood.
 
Last updated: 13.07.2010
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