THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to 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(1), and in particular points (b) to (g) of the second paragraph of Article 29 thereof,
Whereas:
(1) Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.
(2) In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements.
(3) This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community(2), certain recommendations of the Council of Europe, the opinion of the Scientific Committee for Medicinal Products and Medical Devices, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products and recommendations of the World Health Organisation (WHO), as well as international experience in this field.
(4) Blood and blood components imported from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood and human plasma, should meet the quality and safety requirements set out in this Directive.
(5) With regard to blood and blood components collected for the sole purpose of, and exclusive use in, autologous transfusion (autologous donation), specific technical requirements should be laid down, as required by Article 2(2) of Directive 2002/98/EC. Such donations should be clearly identified and kept separate from other donations to ensure that they are not used for transfusion to other patients.
(6) It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.
(7) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,
HAS ADOPTED THIS DIRECTIVE:
For the purposes of this Directive, the definitions set out in Annex I shall apply.
Member States shall ensure that blood establishments provide prospective donors of blood or blood components with the information set out in Part A of Annex II.
Member States shall ensure that upon agreement of willingness to commence the donation of blood or blood components, donors provide the information set out in Part B of Annex II to the blood establishment.
Blood establishments shall ensure that donors of whole blood and blood components comply with the eligibility criteria set out in Annex III.
Blood establishments shall ensure that the storage, transport and distribution conditions for blood and blood components comply with the requirements set out in Annex IV.
Blood establishments shall ensure that the quality and safety requirements for blood and blood components comply with the requirements set out in Annex V.
1.Blood establishments shall ensure that autologous donations comply with the requirements set out in Directive 2002/98/EC and the specific requirements set out in this Directive.
2.Autologous donations shall be clearly identified as such and shall be kept separate from allogeneic donations.
Member States shall ensure that all testing and processes referred to in Annexes II to V are validated.
1.Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 8 February 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
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.
Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.
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.
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:
read and understood the educational materials provided;
had an opportunity to ask questions;
been provided with satisfactory responses to any questions asked;
given informed consent to proceed with the donation process;
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
acknowledged that all the information provided by the donor is true to the best of his/her knowledge.
Under exceptional circumstances, individual donations from donors who do not comply with the following criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of Directive 2002/98/EC.
The following criteria do not apply to autologous donations.
| Haemoglobin | for females ≥ 125 g/l | for males ≥ 135 g/l | Applicable to allogeneic donors of whole blood and cellular components |
| Protein | ≥ 60 g/l | The protein analysis for apheresis plasma donations must be performed at least annually |
| Platelets | Platelet number greater than or equal to 150 × 109/l | Level required for apheresis platelet donors |
The tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclusively for plasma for fractionation.
| Cardiovascular disease | Prospective donors with active or past serious cardiovascular disease, except congenital abnormalities with complete cure |
| Central nervous system disease | A history of serious CNS disease |
| Abnormal bleeding tendency | Prospective donors who give a history of a coagulopathy |
| Repeated episodes of syncope, or a history of convulsions | Other than childhood convulsions or where at least three years have elapsed since the date the donor last took anticonvulsant medication without any recurrence of convulsions |
| Gastrointestinal, genitourinary, haematological, immunological, metabolic, renal, or respiratory system diseases | Prospective donors with serious active, chronic, or relapsing disease |
| Diabetes | If being treated with insulin |
| Infectious diseases | Hepatitis B, except for HBsAg-negative persons who are demonstrated to be immune |
| Hepatitis C | |
| HIV-1/2 | |
| HTLV I/II | |
| Babesiosis (*) | |
| Kala Azar (visceral leishmaniasis) (*) | |
| Trypanosomiasis cruzi (Chagas' disease) (*) | |
| Malignant diseases | Except in situ cancer with complete recovery |
| Transmissible spongiform encephalopathies (TSEs), (e.g. Creutzfeldt Jakob Disease, variant Creutzfeldt Jakob Disease) | Persons who have a family history which places them at risk of developing a TSE, or persons who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands. For variant Creutzfeldt Jacob disease, further precautionary measures may be recommended. |
| Intravenous (IV) or intramuscular (IM) drug use | Any history of non-prescribed IV or IM drug use, including body-building steroids or hormones |
| Xenotransplant recipients | |
| Sexual behaviour | Persons whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood |
After an infectious illness, prospective donors shall be deferred for at least two weeks following the date of full clinical recovery.
However, the following deferral periods shall apply for the infections listed in the table:
| Brucellosis (*) | 2 years following the date of full recovery |
| Osteomyelitis | 2 years after confirmed cured |
| Q fever (*) | 2 years following the date of confirmed cured |
| Syphilis (*) | 1 year following the date of confirmed cured |
| Toxoplasmosis (*) | 6 months following the date of clinical recovery |
| Tuberculosis | 2 years following the date of confirmed cured |
| Rheumatic fever | 2 years following the date of cessation of symptoms, unless evidence of chronic heart disease |
| Fever > °C | 2 weeks following the date of cessation of symptoms |
| Flu-like illness | 2 weeks after cessation of symptoms |
| Malaria (*) | |
|---|---|
—individuals who have lived in a malarial area within the first five years of life | 3 years following return from last visit to any endemic area, provided person remains symptom free; may be reduced to 4 months if an immunologic or molecular genomic test is negative at each donation |
—individuals with a history of malaria | 3 years following cessation of treatment and absence of symptoms. Accept thereafter only if an immunologic or molecular genomic test is negative |
—asymptomatic visitors to endemic areas | 6 months after leaving the endemic area unless an immunologic or molecular genomic test is negative |
—individuals with a history of undiagnosed febrile illness during or within six months of a visit to an endemic area | 3 years following resolution of symptoms; may be reduced to 4 months if an immunologic or molecular test is negative |
| West Nile Virus (WNV) (*) | [F128 days after leaving a risk area of locally acquired West Nile Virus unless an individual Nucleic Acid Test (NAT) is negative] |
Textual Amendments
| Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative |
| Persons whose behaviour or activity places them at risk of acquiring infectious diseases that may be transmitted by blood. | Defer after cessation of risk behaviour for a period determined by the disease in question, and by the availability of appropriate tests |
| Attenuated viruses or bacteria | 4 weeks |
| Inactivated/killed viruses, bacteria or rickettsiae | No deferral if well |
| Toxoids | No deferral if well |
| Hepatitis A or hepatitis B vaccines | No deferral if well and if no exposure |
| Rabies | No deferral if well and if no exposure If vaccination is given following exposure defer for one year |
| Tick-borne encephalitis vaccines | No deferral if well and if no exposure |
| Pregnancy | 6 months after delivery or termination, except in exceptional circumstances and at the discretion of a physician |
| Minor surgery | 1 week |
| Dental treatment | Minor treatment by dentist or dental hygienist — defer until next day (NB: Tooth extraction, root-filling and similar treatment is considered as minor surgery) |
| Medication | Based on the nature of the prescribed medicine, its mode of action and the disease being treated |
| Particular epidemiological situations (e.g. disease outbreaks) | Deferral consistent with the epidemiological situation (These deferrals should be notified by the competent authority to the European Commission with a view to Community action) |
| Serious cardiac disease | Depending on the clinical setting of the blood collection |
| Persons with or with a history of
| Member States may, however, establish specific provisions for autologous donations by such persons |
| Active bacterial infection |
| Component | Temperature of storage | Maximum storage time |
|---|---|---|
| Red cell preparations and whole blood (if used for transfusion as whole blood) | + 2 to + 6 °C | 28 to 49 days according to the processes used for collection, processing and storage |
| Platelet preparations | + 20 to + 24 °C | 5 days; may be stored for 7 days in conjunction with detection or reduction of bacterial contamination |
| Granulocytes | + 20 to + 24 °C | 24 hours |
| Component | Storage conditions and duration |
|---|---|
| Red blood cells | Up to 30 years according to processes used for collection, processing and storage |
| Platelets | Up to 24 months according to processes used for collection, processing and storage |
| Plasma and cryoprecipitate | Up to 36 months according to processes used for collection, processing and storage |
| Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allowable storage period after thawing to depend on the method used. | |
Transport and distribution of blood and blood components at all stages of the transfusion chain must be under conditions that maintain the integrity of the product.
| Component | Quality measurements required The required frequency of sampling for all measurements shall be determined using statistical process control | Acceptable results for quality measurements |
|---|---|---|
| Red cells | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 45 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, buffy coat removed | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 43 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 40 g per unit | |
| Leucocyte content | Less than 1 × 106 per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, in additive solution | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 45 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, buffy coat removed, in additive solution | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 43 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, leucocyte-depleted, in additive solution | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 40 g per unit | |
| Leucocyte content | Less than 1 × 106 per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, apheresis | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 40 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Whole blood | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis 450 ml +/- 50ml For paediatric autologous whole blood collections — not to exceed 10,5 ml per kg body weight |
| Haemoglobin (*) | Not less than 45 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Platelets, apheresis | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions | |
| pH | [F2Minimum 6,4 corrected for 22 °C, at the end of the shelf life] | |
| Platelets, apheresis, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 1 × 106 per unit | |
| pH | [F2Minimum 6,4 corrected for 22 °C, at the end of the shelf life] | |
| Platelets, recovered, pooled | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 0,2 × 109 per single unit (platelet-rich plasma method) Less than 0,05 × 109 per single unit (buffy coat method) | |
| pH | [F2Minimum 6,4 corrected for 22 °C, at the end of the shelf life] | |
| Platelets, recovered, pooled, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 1 × 106 per pool | |
| pH | [F2Minimum 6,4 corrected for 22 °C, at the end of the shelf life] | |
| Platelets, recovered, single unit | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 0,2 × 109 per single unit (platelet-rich plasma method) Less than 0,05 × 109 per single unit (buffy coat method) | |
| pH | [F2Minimum 6,4 corrected for 22 °C, at the end of the shelf life] | |
| Platelets, recovered, single unit, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions | |
| Leukocyte content | Less than 1 × 106 per unit | |
| pH | [F2Minimum 6,4 corrected for 22 °C, at the end of the shelf life] | |
| Plasma, fresh-frozen | Volume | Stated volume +/- 10 % |
| Factor VIIIc (*) | Average (after freezing and thawing): 70 % or more of the value of the freshly collected plasma unit | |
| Total protein (*) | Not less than 50 g/l | |
| Residual cellular content (*) | Red cells: less than 6,0 × 109/l Leucocytes: less than 0, 1 × 109/l Platelets: less than 50 × 109/l | |
| Plasma, fresh-frozen, cryoprecipitate-depleted | Volume | Stated volume: +/- 10 % |
| Residual cellular content (*) | Red cells: less than 6,0 × 109/l Leucocytes: less than 0,1 × 109/l Platelets: less than 50 × 109/l | |
| Cryoprecipitate | Fibrinogen content (*) | Greater than or equal to 140 mg per unit |
| Factor VIIIc content (*) | Greater than or equal to 70 international units per unit | |
| Granulocytes, apheresis | Volume | Less than 500 ml |
| Granulocyte content | Greater than 1 × 1010 granulocytes per unit |
Textual Amendments