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Minister of Health and Sports,
In light of Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and the Council on certain technical requirements for blood and blood components;
Vu le Public Health Code, including article R. 1221-5 ;
In the light of the opinion of the Director General of the French Health Product Safety Agency dated 3 November 2008,
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The criteria for selecting blood donors are:
I. ― Age limit of donors:
Prior to the age of 18, no donation is authorized, except in the case provided for in thearticle L. 1221-5.
From 18 to 65 years old, any type of donation is possible, except the donation of granulocyte, which is only allowed up to 50 years. The first donation after 60 years is subject to the appreciation of a doctor at the blood transfusion facility.
After 65 years, only the total blood donation is allowed and provided that each donation is authorized by a doctor at the blood transfusion facility.
After 70 years, no donations are authorized, except as set out in the VII of this section.
No donation is allowed for protected majors.
II. ― Interval between donations:
The minimum interval between two donations is:
- two weeks between a plasma donation and any other type of donation;
– four weeks between a gift of platelets or a donation of granulocytes and any other type of cellular donation, this period may be reduced for compatible HLA donors, according to the doctor's appreciation;
– eight weeks between a gift of total blood or red blood cells in combined apheresis and any other donation of red blood cells;
― sixteen weeks between a simple short-lived donation of red blood cells and any other donation of red blood cells.
The intervals to be met by the different combinations between two types of donations are the subject of a table in Appendix I to this Order.
III. - Frequency of sampling:
For a period of twelve months, with a tolerance of fifteen days, the number of gifts, all types, is less than or equal to twenty-four.
The number of units of red blood cell concentrates collected in total blood and/or apheresis is less than or equal to six per year for men and four per year for women.
The number of donations of platelet concentrates by apheresis is less than or equal to twelve per year for men and women.
The number of plasma donations is less than or equal to twenty-four per year for men and women.
The number of donations of granulocytes per apheresis is less than or equal to two for men and women and can be increased to four in the case of therapeutic necessity, appreciated by a doctor at the blood transfusion facility.
IV. - Sampling volume:
When a total blood sample is collected, excluding samples and anticoagulants, is less than or equal to 13% of the estimated total blood volume of the donor, but not more than 500 ml.
The total volume of blood components taken, excluding samples and anticoagulants, is less than or equal to 13% of the estimated total blood volume of the donor, but not more than 650 ml.
When sampling plasma aesis, the volume taken, excluding samples and anticoagulants is less than or equal to 16% of the estimated total blood volume of the donor, but not more than 750 ml.
For any sampling, beyond 40 ml, the additional sample volume is subtracted from the total sample volume.
V.- Clinical and biological characteristics of the donor:
1. Clinical characteristics:
During the prior maintenance of the donation, it is up to the person authorized to make the selection of the donors to appreciate the possibility of a donation in respect of counter-indications and their duration, their anteriority and their evolution, through additional questions to the questionnaire prior to the donation.
Sampling is not permitted if the failure to understand the gift applicant presents a risk of insufficient or inadequate response.
The candidate shall be deferred from the gift if he presents a counter-indication referred to in one of the tables in Appendix II to this Order. Health authorities may modify, add or delete contraindications to blood donation based on specific epidemiological situations or data of hemovigilance.
A minimum weight of 50 kg is required for any type of donation.
For simple apheral removals of red blood cells, the total blood volume of the donor is equal to or greater than 5 litres.
2. Biological characteristics:
The hemoglobin rate is at least:
120 g / l for women and 130 g / l for men for all cellular donations;
- 140 g/l for men and women for donations in simple apheresa of red blood cells;
― 120 g / l for women and 130 g / l for men for plasma donations and, below these values, levy is left to the appreciation of a doctor at the blood transfusion facility.
For the gift of platelets, the platelet count is greater than or equal to 150 × 109 / l, with a possible derogation for compatible HLA and HPA donors, depending on the doctor's appreciation.
The protide rate is greater than or equal to 60 g / l for plasma donations and platelet donations.
The continuation of the simple apherèse donations of red blood cells can only be done if the ferritinemia realized on the occasion of the first simple apherèse of red blood cells is greater than 20 ng / ml.
VI. - Provisions specific to plasma sampling for fractionation:
Contraindications in Appendix II by an asterisk (*) are not applicable to plasma sampling for fractionation.
VII. - Provisions specific to rare blood samples:
These provisions are contained in annex III to the present order.
VIII. - Special provisions for exclusively non-therapeutic sampling:
These provisions are contained in annex IV to the present order.
IX. - Special provisions for autologous sampling:
These provisions are contained in annex V to the present order.
X. ∙ Provisions relating to genetic hemochromatosis donors:
These provisions are contained in annex VI to the present order.
The implementation of the selection criteria set by this Order is subject to a regular assessment by the French Blood Establishment and the Blood Transfusion Centre of the Armed Forces and a quarterly review of the epidemiological monitoring of blood donors is transmitted by the Health Watch Institute to the Minister responsible for health.
This Order will be reviewed once a year.
This Order shall enter into force three months after its publication in the Official Journal of the French Republic.
The present order will be issued in the Official Journal of the French Republic.
ANNEX III
A sampling may be carried out on an exceptional basis:
- for therapeutic emergency reasons and when tissue compatibility requires it;
- to ensure, inter alia, the transfusion coverage of some patients with complex immunization or rare phenotype, when the search for suitable products for these patients has led to the selection of donors with certain counter indications;
- for rare erythrocytary phenotypes, and the needs expressed by the national rare phenotype blood bank (BNSPR).
These cases are elements of appreciation of the need to derogate from the sampling rules and the donor selection criteria defined in Article 1 and Annex II to this Order.
The physician in charge of sampling shall, on a case-by-case basis, determine the exemptions to the sampling rules that it authorizes, in the case of age limits, the sample volume, the weight of the candidate and the interval between the donations, in accordance with the following rules:
- outside the age limits, volume and interval of donations provided for in section 1 and annex I to this Order, the possibility of taking a candidate for the donation is left to the assessment of the doctor of the blood transfusion institution (ETS) and will be appreciated according to the clinical and biological tolerance of the donor candidate. For a minor, the consent of the holders of parental authority is required, the refusal of the minor obstructing the removal;
― the removal of donors weighing less than 50 kg is left to the doctor's appreciation of the blood transfusion institution, provided that, for a total blood donation, the volume taken does not exceed 13% of the estimated blood volume.
When the derogation concerns the identification of a possible risk of communicable disease, specific procedures specify the conditions for the collection, preparation, qualification, conservation, transport and delivery of labiles blood products (LPS).
In this case, whenever an exemption from the use of the LLP is considered, the decision to take is made jointly by the physician responsible for the collection of the STA, the physician responsible for the distribution and delivery, and, where applicable, by the local correspondent of the NPA.
A suitable post-done, biological or clinical control, where possible or indicated, will be carried out in the donor who has presented a transmissible disease risk factor. The results will be transmitted, if any, to the National Reference Centre for Blood Groups (CNRGS) and to the SNB.
Apart from the counter-indications referred to in the preceding paragraph, any other counter-indication may be considered on a case-by-case basis if the counter-indication does not question the security of the donor. The decision to take in a derogatory setting is taken jointly by the doctor in charge of the sampling and the doctor in charge of the sampling of the ETS, after assessing the clinical and/or biological fitness of the candidate for the donation.
These provisions do not preclude the existing regulations on exemptions for biological analysis and testing for blood samples intended for use, in the event of compelling therapeutic necessity and in the preparation of labial blood products for self-testing.
SPECIAL PROVISIONS
NON-THERAPETIC PRELINES
Field of application of non-therapeutic levies: any type of labile blood products and samples from a homologous blood donation, taken by the ETS, regardless of their mode of conditioning.
These products are intended to:
― laboratory research, apart from research on people;
– manufacturing of in vitro diagnostic medical devices (DMDIV);
― the conduct of tests and analyses of medical biology;
- teaching.
Applicants to the donation are subject to a reception procedure identical to that established for a therapeutic donation.
The acceptance criteria for non-therapeutic blood donation can be expanded according to the destination of the sampling.
There are commonly three types of non-therapeutic sampling:
― levies for teaching: donors are selected in the same way as for a gift for therapeutic use;
― levies intended for the manufacture of in vitro diagnostic medical devices (DMDIV) or for the conduct of medical biology tests and analyses: these levies are managed according to the provisions below, with the exception of those relating to derogatory levies;
― samplings for research laboratories: donors are selected according to the needs expressed in a specific convention between the ESA or the CTSA and the laboratory concerned, in accordance with the donor's safety.
The frequency, the interval between the donations and the volumes taken are identical to those made under the same grant.
In the case of fractional sampling, less than the volume usually taken from a blood donor, the total volume taken from a given period must never exceed that allowed for therapeutic donations over the same period. These provisions apply to donations of total blood, plasmapheresis and cellular apheresis.
By derogation from the sampling rules and the donor selection criteria defined in Article 1 of this Order, in the event that it is envisaged to collect subjects less than 50 kg, the maximum amount of total blood collected never exceeds 13% of the total blood volume estimated from the donor's weight. The removal of these donors is left to the appreciation of the sampling physician.
Contraindications to the donation to protect the donor's health apply to non-therapeutic sampling. However, the sampling physician will take into account, for his assessment, the volume taken, the nature and the frequency.
Contraindications to the donation intended to protect the health of the recipient do not apply to non-therapeutic sampling.
Donors with a positive HIV virus marker, HCV, HBV (HB antigen) are counter-indicated for non-therapeutic donation, except in case of derogatory sampling.
Derogatory levies: for reasons of scientific interest and/or reagents, in case of positive markers of HIV viruses, HCV, HBV (HB antigen), certain levies may, exceptionally, derogate from the above rules. Sampling is then carried out within the framework of specific procedures and conventions that define precisely the conditions:
- selection of donors;
- the information of the donor and the informed collection of his consent;
- information of the collection teams;
- sampling;
– protecting all involved actors and the environment;
- the delivery of the products and samples taken.
Annex V
SPECIAL PROVISIONS
AUTOLOGICAL PREPARATION
The donor selection criteria defined in Article 1 and Annex II to this Order are not applicable to the collection of autologous blood.
In the case of heart disease, the doctor appreciates the possibility of taking the blood sample clinical context.
In case of bacterial infection, the sampling is contraindicated for a period left to the doctor's appreciation.
Contraindication to anemia is left to the doctor's appreciation of the blood transfusion facility.
It is also permanently contraindicated in case of neurological decompensation and hemostasis pathology and coagulopathy.
These provisions do not preclude the application of the existing regulations relating to exemptions for biological analysis and testing of blood samples for autologous transfusion.
PROVISIONS RELATING TO DONNORS
GENERAL HEMOCHROMATOSE
Genetic hemochromatosis is not a contraindication to blood donation.
In the case of indications of therapeutic blood loss, the blood donation is authorized, on the proposal of a doctor of the French Blood Institution or the Blood Transfusion Centre of the Armed Forces, subject to informed information from the donor and his consent, and in accordance with the following conditions:
― sampling is done on a transfusion site including a health centre;
― sampling is done in collaboration with the medical team monitoring the patient;
the gift meets the selection criteria set out in this Order. The doctor may decide to waive the provisions on the intervals between two donations and the number of donations per year.
Done in Paris, January 12, 2009.
Roselyne Bachelot-Narquin
