Key Benefits:
Minister of Health and Sports,
Vu le Public Health Code, including article L. 1413-5 ;
Having regard to the amended decision of 1 June 2001 on the carriage of dangerous goods by road (known as "ADR");
Having regard to the decision of 24 April 2002 on the approval of the regulations on good practices for the transport of samples, products and samples derived from human blood;
In view of the decision of 29 November 2004 setting out the terms and conditions of designation and the missions of national reference centres for the control of communicable diseases;
In view of the decision of 12 March 2007 setting out the list of national reference centres for the control of communicable diseases and associated laboratories,
Stop it!
The French Blood Establishment transmits to the transfusion virology laboratory of the National Blood Transfusion Institute, as part of its associated laboratory missions of national reference centres for hepatitis B, C and delta and human immunodeficiency viruses, all pockets and plasma samples from blood donors, positive for one or more of the following markers:
• HIV-1 / HIV-2;
- ARN-VIH;
- anti-VHC;
- ARN-VHC;
- HBs antigen;
ADN –-VHB;
― antibodies anti-HBc newly detected in a known donor;
- antibodies anti-HTLV.
The French Blood Establishment also transmits to the National Reference Centre the pockets and samples of plasma from donors with an atypical clinical-biological profile likely to correspond to a hepatitis or retroviral infection related to a mutant virus.
Plasma pockets and samples are ceded by the French Blood Institution at the Transfusion Virology Laboratory of the National Institute for Gracious Blood Transfusion.
The plasma to be transmitted to the transfusion virology laboratory of the National Institute of Blood Transfusion is two sources:
1 to 2 ml of plasma from controlled and collected tubes during blood donation;
100 ml of plasma from plasma pockets prepared from blood donation.
Plasma from the pockets prepared from the blood donation is conditioned in pockets by sterile connection and labeled by the French Blood Institution, so as to ensure the traceability link between the original pocket, the recipient pocket, the gift and the corresponding questionnaire sent to the Health Watch Institute, according to the regulations in force.
When the plasma pocket is not available, in the case of a simple aesthetic of red platelets or blood cells, as well as in the case of a plasma pocket destroyed during preparation, only the sample from the control tubes is sent to the transfusion virology laboratory of the National Blood Transfusion Institute, with mention of the non-availability pattern of the plasma pocket.
The pouches and plasma samples to be transmitted are conditioned and transported in accordance with the above-mentioned April 24, 2002.
The transfusion virology laboratory of the National Institute of Blood Transfusion ensures the charge and responsibility of the transport, which is carried out by a provider in accordance with the provisions of the aforementioned decision of 1 June 2001.
Any complementary practical provisions related to transport will be established directly between the French Blood Institution and the Transfusion Virology Laboratory of the National Blood Transfusion Institute.
A sheet is attached to the pockets and samples of transmitted plasma. It includes, at a minimum, the identification of the sender and the pre-harvest blood transfusion facility, the donation identifier, and the name of the virus.
The products transmitted by the French Blood Establishment are used by the transfusion virology laboratory of the National Blood Transfusion Institute as part of the missions entrusted to it under the above-mentioned decree of 29 November 2004.
The transfusion virology laboratory of the National Institute of Blood Transfusion cannot carry out any direct industrial exploitation of all or part of the plasmas transmitted by the French Blood Establishment by an assignment to another organism, apart from collaborations that could occur between national or international expert laboratories.
The transfusion virology laboratory of the National Institute of Blood Transfusion provides the person responsible for the qualification laboratory of donations from the pre-harvesting blood transfusion facility with details of the results of the investigations carried out in its missions. A copy of each final result is sent simultaneously to the person responsible for the French Blood Institution mentioned in theArticle R. 1222-9-1 of the Public Health Code and the national plasma library.
The results of the analyses carried out contribute to the development of the annual activity report provided to the Health Watch Institute.
Any oral or written scientific communication relating to the national surveillance of infections by hepatitis B and C viruses and human immunodeficiency in blood donors is carried out according to the publication rules defined by the Health Watch Institute, the National Institute for Blood Transfusion and the French Blood Institution as part of the steering committee "epedemiological surveillance of blood donors".
The present order will be issued in the Official Journal of the French Republic.
Done in Paris, February 6, 2009.
Roselyne Bachelot-Narquin
