Key Benefits:
The Prime Minister,
On the report of the Minister of Health and Solidarity,
In view of Directive 2002 /98/EC of the European Parliament and of the Council of 27 January 2003 establishing Quality and safety standards for the collection, control, processing, storage and distribution of human blood and blood components and amending Directive 2001 /83/EC;
In view of Commission Directive 2004 /33/EC Of 22 March 2004 implementing Directive 2002/95/EC of the European Parliament and of the Council on certain technical requirements relating to blood and blood components;
Given the code of public health, in particular Title II of the Book II of the first part;
In view of Order No. 2005-1087 of 1 September 2005 on national public health establishments and disputes in the field of blood transfusion;
In light of Decree No. 76-1004 of 4 November 1976 laying down the conditions for the authorisation of laboratories for the analysis of medical biology, and in particular Article 9.1;
In view of Decree No. 94-68 of 24 January 1994 on hemovigilance rules;
In the opinion of the French Agency for Health product safety as of 5 July 2005;
Given the opinion of the French Blood Establishment dated 5 July 2005;
The Conseil d' Etat (social section) heard,
Décrète:
Chapter I of Title II of Book II of Part I of the Code of Public Health (Regulations) is amended as follows:
I.-The title of section 2 is amended as follows: Biological Qualification of Blood Donation ".
II. -It is created in this section a sub-section 1 entitled: Donor Screening " In which an article R. 1221-5 reads as follows:
" Art. R. 1221-5. -Before pre-meeting with the donation of blood, the applicant for this donation shall complete a questionnaire, the form and content of which shall be defined by decision of the Director General of the French Health Products Safety Agency after notice of the The French Blood Establishment and the Army Blood Transfusion Centre.
" At the end of the pre-donation interview, the candidate certifies to have:
" -read and understand the detailed information provided to it;
" -eu Opportunity to ask questions and get answers;
" -informed consent to proceed with the donation process;
" -has been informed, in the case of autologous collection, of the possibility that blood products Autologous may not be sufficient to meet the requirements of the intended
. It further certifies that all the information it has provided is, to the best of its knowledge, correct, by signing it on the part of the questionnaire intended for that purpose. This section is countersigned by the person authorized to conduct donor screening and who has obtained information about the health status and medical history of the donors. A decision by the Director General of the French Health Products Safety Agency specifies the data relating to the selection of the donor, which must be kept by the French Blood Establishment. "
III. -It is created in the same section a sub-section 2 entitled: Biological analyses and screening tests ".
In this subsection, articles D. 1221-5, D. 1221-6, D. 1221-7, D. 1221-8, D. 1221-9, D. 1221-10, D. 1221-11, D. 1221-12, D. 1221-13, D. 1221-14 and D. 1221-15 become respectively the articles D. 1221-6, D. 1221-7, D. 1221-8, D. 1221-9, D. 1221-10, D. 1221-11, D. 1221-12, D. 1221-13, D. 1221-14, D. 1221-15 and D. 1221-16.
Section 3 of the same chapter is amended as follows: " Distribution and delivery of blood components ".
This section includes R. 1221-17 to R. 1221-21 thus written :
" Art. R. 1221-17. -For the purposes of this section, "
" means: 1 ° Distribution of blood components: the provision of blood components by blood establishments to other blood establishments, Health care facilities managing blood depots and manufacturers of health products derived from human blood or its components;
" 2 ° Issuance of blood components: the provision of blood components on the Medical prescription for administration to a specified patient. It shall be performed by ensuring immunological compatibility, in accordance with the medical prescription and the implementation of the hemovigilance rules.
" Art. R. 1221-18. -Each public or private health institution shall select a single blood transfusion establishment, known as a reference blood transfusion establishment, which shall provide for the distribution and delivery of blood components necessary for its Needs. He shall communicate the name of the establishment to the regional prefect and to the regional agency for competent
. The French Blood Establishment makes known to the French Health Products Safety Agency the list of Health facilities supplied by the referral blood establishments. The blood transfusion centre of the armies also makes known to the agency the establishments it supplies.
" Art. R. 1221-19. -Health care facilities retain blood components for direct therapeutic use in units called blood depots. A blood deposit is a unit that retains and delivers, under the authority of a physician or a pharmacist, blood products intended exclusively for use in the health care facility and, if applicable, Compatibility tests. It also retains blood components issued by its blood establishment for referral to patients at the health care facility.
" A health care facility cannot deliver a blood product Labile for a patient hospitalized in another health care facility than in the case of a vital transfusion emergency.
" Products that have been the subject of such a grant cannot subsequently be issued for another patient.
" The Qualification of personnel assigned to the issue of blood components meets the requirements of R. 1222-23.
" Art. R. 1221-20. -Where a deposit of blood is authorized in a health facility by the regional hospital agency under Article L. 1221-10, a convention shall be entered into between the depositary health establishment and its establishment Blood transfusion referent to organize the maintenance of the deposit and the monitoring of the retained products. A copy of this agreement is sent to the prefect.
" A decree of the Minister responsible for health, taken after the opinion of the President of the French Blood Establishment, the director of the blood transfusion centre of the armed forces and the director general of the The French Health Products Safety Agency, lays down the mandatory clauses to be included in this convention.
" Art. R. 1221-21. -Blood establishments and health facilities authorised to keep blood components for therapeutic use shall be equipped with a procedure for the removal of the circuit from any unit of Such products. "
Section 4 of the same chapter is amended as follows: " Hemovigilance ".
I.-In this section 4 a sub-section 1 entitled: General Provisions " And including R. 1221-22 and R. 1221-23 written:
" Art. R. 1221-22. -Blood safety is an element of transfusion safety. It includes, for all blood donations and for all labile blood products:
" 1 ° Reporting and reporting of serious incidents;
" 2 ° Reporting and reporting of any serious adverse reactions in a blood donor ;
" 3 ° Reporting and reporting of any adverse reactions in a recipient of blood components;
" 4 ° The collection, preservation and accessibility of information on blood samples, preparation, The use of blood components as well as the incidents and effects mentioned in 1 °, 2 ° and 3 ° above;
" 5. The assessment and operation of this information in order to prevent the occurrence of any incident or effect referred to in 1 °, 2 ° or 3 ° above;
" 6 ° The carrying out of any studies or any work concerning incidents or the risks of incidents and adverse reactions related to the aforesaid
. It also includes the collection, conservation and The availability of information on the epidemiology of blood donors and candidates for the planned autologous
. Art. R. 1221-23. -For the purposes of this section, "
" means: 1 ° Adverse reaction: the noxious response in donors and related or likely to be related to blood sampling or that occurred in recipients and related or susceptible Be related to the administration of a labile blood product;
" 2 ° Serious adverse reaction: the adverse effect causing death or life threatening, resulting in disability or incapacity, or causing or prolonging Hospitalization or other morbid condition;
" 3 ° Incident: the blood sampling incident, the biological qualification of the donation, the preparation, preservation, distribution, issue or use of products Blood labile, due to an accident or error, likely to affect the safety or quality of the product and cause adverse reactions;
" 4 ° Serious incident: the incident likely to result in serious adverse reactions. "
II. -In the same section 4, a sub-section 2 is created entitled: National Blood Safety System " Including section R. 1221-24 worded as follows:
" Art. R. 1221-24. -National Blood Safety System includes:
" -Agence française de sécurité sanitaire des produits de santé;
-National Blood Safety Commission;
" -the regional hemovigilance coordinators mentioned in article R. 1221-32;
" -the French Blood Establishment and the Army Blood Transfusion Centre;
" -Institute for Health Surveillance;
" -health care facilities and military hospitals;
" -any health professional. "
III. -In the same section 4, a sub-section 3 is created entitled: Role of the French Health Products Safety Agency " Including R. 1221-25 to R. 1221-27 thus written:
" Art. R. 1221-25. -The French Health Products Safety Agency ensures the implementation of hemovigilance. It defines the guidelines, animates and coordinates the actions of the various stakeholders and ensures compliance with the monitoring procedures organised by this section. It shall, where appropriate, take the appropriate measures to ensure the safety of the transfusion or seize the competent
. For the purpose of this mission, the Agency is the recipient of the following documents and information:
" 1 ° Under the conditions set out in sections R. 1221-50 and R. 1221-51 Serious Incident Reports as well as Statements of Serious Adverse Reaction in Blood Donors and Adverse Reaction Reports in Recipients Blood components;
" 2. Any information collected during the various stages of the transfusion chain that could compromise the quality and safety of blood components;
" 3 ° Data from the Epidemiological surveillance of blood donors and candidates for the planned autologous transfusion carried out by the Institute for Health
. The Agency also conducts or conducts epidemiological investigations and studies Relating to conditions of use of blood components.
" Art. R. 1221-26. -The Agence française de sécurité sanitaire des produits de santé communicates to the French Blood Establishment and to the Blood Transfusion Centre the information relating to the safety and quality of the blood products produced Other alertness systems.
" Art. R. 1221-27. -The Agence française de sécurité sanitaire des produits de santé establishes a summary report on haemovigilance on an annual basis. This report shall be sent to the Minister for Health and to the European Commission no later than 30 June of the following year. "
IV. -In the same section 4, a sub-section 4 is created entitled: National Blood Safety Commission ".
It includes R. 1221-28 to R. 1221-31 written as follows:
" Art. R. 1221-28. -The National Blood Safety Commission sits on the French Health Product Safety
. It has for missions:
" 1 ° give an opinion on the balance sheet of the information collected;
" 2 ° propose the Conducting surveys and studies and evaluating results;
" 3 ° To give an opinion to the Director General of the Agency on the measures taken or to be taken to prevent the occurrence or repetition of any incident or adverse reaction;
" 4 ° To adopt the annual haemovigilance report referred to in R. 1221-27.
" Art. R. 1221-29. -The Minister responsible for health may request the opinion of the committee on any matter falling within the competence of the
. Art. R. 1221-30. -National Blood Safety Commission includes:
" 1 ° Five members of law:
" -the Chief Health Officer or his or her representative;
" -the Director-General of the French Health Products Safety Agency or his Representative;
" -the director of the hospital and the care organisation or his representative;
" -the President of the French Blood Establishment or his representative;
" -the director of the blood transfusion centre of the Armies or their representative.
" 2 ° Twenty members appointed by the Minister responsible for health for a renewable term of three years, including:
-five individuals chosen because of their clinical or biological expertise in Anesthesia-resuscitation, hematology, immunology, infectivity, or virology;
" -four people chosen because of their expertise in the field of sampling, biological qualification, preparation, Distribution of blood components, including one on proposal from the Director of the Army Blood Centre;
" -a nurse with a blood transfusion experience in a health care facility;
" -two Individuals chosen because of their epidemiology skills, including a proposal from the Director General of the Institute for Health Surveillance;
" -two persons performing the duties of haemovigilance in an establishment of Health including one in a military hospital;
" -a person performing the functions of haemovigilance in a blood transfusion establishment designated on the proposal of the President of the establishment French blood after notice from the person responsible;
" -a person performing the duties of a Blood Safety Correspondent in the Blood Transfusion Centre of the designated armies on the proposal of the Director of the Blood Centre Armies blood;
" -two persons performing the duties of Regional Blood Safety Coordinator;
" -a public health inspector or pharmacist;
" -a person selected because of his or her transfusion skills Blood and designated on proposal of the Director of the National Institute of Blood Transfusion
With the exception of the people proposed by the director of the blood transfusion centre of the armies, by the president of the French establishment By the Director General of the Institute of Health Surveillance and the Director of the National Institute of Blood Transfusion, the members mentioned in 2 ° shall be appointed on the proposal of the Director General of the French Safety Agency Health product health.
" Alternates in equal numbers shall be appointed under the same conditions as the full members. They replace them if they are unable to do so. They shall succeed if a vacancy occurs during the term of office, for the remainder of the term of
. The President and the Vice-President shall be appointed by the Minister responsible for health among the members of the committee referred to in 2 °. The vice president displaces the president in case of impediment.
" Art. R. 1221-31. -The National Blood Safety Commission may hear any qualified person. It can call on rapporteurs and experts appointed by the Director-General of the French Health Products Safety
. The deliberations of the panel shall be confidential. The members of the committee and the personalities assisting them shall be bound by professional secrecy under the conditions laid down in Article 226-13 of the Criminal Code. The travel expenses of the members of the committee, rapporteurs and experts shall be reimbursed under the conditions laid down in the applicable rules applicable to officials of the
. The secretariat of the National Commission Hemovigilance is provided by the French Health Products Safety Agency. "
V.-In the same section 4, a sub-section 5 is created as follows: Regional Blood Safety Coordinators ".
It includes R. 1221-32 to R. 1221-35 thus written:
" Art. R. 1221-32. -In each region, a Blood Safety Coordinator with the Regional Director of Health and Social Affairs is responsible for:
" 1 ° To follow the implementation by the health and blood transfusion institutions of the region of Provisions of this section and, where appropriate, decisions of the Director General of the French Agency for Health Product Safety and of the actions taken by the Transfusion Safety and Blood Safety Committees Institutions;
" 2 ° To maintain direct relations with each of the haemovigilance correspondents in the region, to ensure with them the quality and reliability of the information collected pursuant to Articles R. 1221-39 and R. 1221-43 and to be kept informed of any difficulties the correspondents would encounter in the exercise of their mission;
" 3 ° To inform the regional prefect and the agency of his activity, in particular by means of an annual activity report, of which he addresses Copy to the French Blood Establishment;
" 4 ° To propose, where appropriate, to the agency, under the cover of the regional prefect, the adoption of any measures which may improve the quality, reliability and consistency of the haemovigilance device ;
" 5 ° To seize without delay the regional prefect and the agency of any difficulty which could jeopardise the blood safety and to inform the French Blood Establishment at the same time;
" 6. To propose, where appropriate, to the Département prefect the measures to be taken in the light of the fact sheets received pursuant to Article R. 1221-50.
" Art. R. 1221-33. -At the request of the Agence française de sécurité sanitaire des produits de santé or the regional prefect, or on his own initiative, the Regional Blood Safety Coordinator shall be contacted by the appropriate Blood Safety Correspondent (s) Any information that blood or blood establishments collect and hold under this chapter.
" On the basis of this information, the coordinator shall proceed or arrange by the correspondents Hemovigilance with any research useful for haemovigilance, including:
" 1 ° Identification of any labile blood product unit prepared from a donation;
" 2 ° Identification of all units administered to a patient Determined or searched for any adverse effects related to, or likely to be related to, the administration of a specific labile blood product unit or type;
" 3 ° Epidemiological data on blood donors Come from units of blood components referred to at 1 ° and 2 °.
" In accordance with the anonymity of donors and recipients, the Regional Blood Safety Coordinator shall forward the results of the investigations referred to above to the Regional Prefect and the French Health Products Safety Agency.
" A decision by the Director General of the French Health Products Safety Agency after notification of the French Blood Establishment and the French Blood transfusion centre of the armed forces may lay down the arrangements for the exchange of information, linked to such investigations, between, on the one hand, the establishments and the coordinator and, on the other hand, between the coordinator and the agency
Art. R. 1221-34. -Where necessary in the interest of hemovigilance, the Regional Blood Safety Coordinator shall forward to another regional coordinator an information of which he/she is the holder. He informed the French Health Products Safety
of the health products. Art. R. 1221-35. -The Regional Blood Safety Coordinator is a hospital doctor with equivalent qualifications, with experience in blood transfusion. He is appointed for a period of three years, renewable by decree of the regional prefect taken after advice of the French health product safety agency. "
VI. -In the same section 4, a sub-section 6 is set out as follows: Role of Blood Establishments ".
It includes R. 1221-36 to R. 1221-39 thus written:
" Art. R. 1221-36. -I.-Each blood establishment shall collect and maintain, for each labile blood product unit for which it is prepared, the following information:
" 1. Identification of blood or component donation Blood from the unit and donor identification;
" 2 ° The results of biological analyses and screening tests performed on the donation;
" 3 ° Identification of blood establishment The recipient of the prepared unit when it was distributed to another blood establishment.
" II. -Each blood establishment shall collect and maintain, for each unit of blood products, its distribution or dispensing, the following information:
" 1 ° Identification of The health facility to which units of labile blood products have been distributed or issued, and, where a health care facility issues a labile blood product for a patient hospitalized in another health care facility, Circumstances of the issuance and identification of the latter;
" 2 ° The identification of the prescriber and the identification of the patient to whom the unit has been administered or, where appropriate, the date of destruction of the unit or its return to Blood establishment.
" III. -Each blood establishment shall transmit to the Institute for Health Surveillance the data necessary for the epidemiological surveillance of blood donors and candidates for the programmed autologous
. Art. R. 1221-37. -At the request of the Agence française de sécurité sanitaire des produits de santé, the blood establishment collects and retains all the information necessary for the hemovigilance to which it has access and which relates to:
" 1 ° Autologous transfusions in which the institution participated;
" 2 ° Pre-transfusion and, where appropriate, post-transfusion tests performed on the patient;
" 3 ° Storage for future analysis of samples Biological blood donation.
" Art. R. 1221-38. -Health institutions shall send to their blood establishments the information referred to in Article R. 1221-36 and 2 ° of Article R. 1221-37
Decisions of the Director General of the French Agency The safety of health products taken after notification of the French Blood Establishment and the Blood Transfusion Centre of the Armed Forces may specify the content of the information referred to in this Article and fix the terms and conditions of their Collection by the establishment of blood transfusions or their transmission by health care
. Art. R. 1221-39. -In each blood establishment, a Blood Safety Correspondent is responsible for ensuring, under the authority of the person responsible:
" 1 ° The collection and retention of the information referred to in Articles R. 1221-36 to R. 1221-38 by ensuring their quality and reliability;
" 2. The declaration, under the conditions and in the manner provided for in Article R. 1221-49, of any serious adverse reactions in a blood donor and any adverse reaction Occurred in a recipient of labile blood products and any serious incident;
" 3 ° Communication to the Agence française de sécurité sanitaire des produits de santé and to the Regional Blood Safety Coordinator mentioned in article R. 1221-32 of the information they seek pursuant to R. 1221-33;
" 4 ° Communication to the Institut de veille sanitaire des informations referred to in III of Article R. 1221-36;
" 5 ° Information of establishments Health on the use of blood components distributed or dispensed by its establishment of blood transfusion and the transmission to such establishments of the information referred to in the first paragraph of Article R. 1221-42;
" 6 ° Reporting to the French Health Products Safety Agency and the Regional Blood Safety Coordinator any difficulties that could compromise the safety of transfusion;
" 7 ° Investigations to be undertaken in case As a result of adverse reactions or serious incidents. In this case, it shall immediately inform the French Health Products Safety Agency, which shall decide whether or not to continue the investigation, as well as the Regional Blood Safety
. The correspondent The Blood Establishment Blood Safety is appointed, as the case may be, by the President of the French Blood Establishment on a proposal from the person in charge or by the Director of the Blood Transfusion Centre. He must be a doctor or pharmacist.
" Specific conditions for the qualification and training of this correspondent may be imposed by order of the Minister responsible for health taken on the proposal of the Director General of the French Agency for Health product health security.
" The name of the correspondent is communicated by the French Blood Establishment or by the Centre for Blood Transfusion of the Armies to the French Health Products Safety Agency and to the French Regional Blood Safety Coordinator. "
VII. -In the same section 4, a sub-section 7 is created as follows: The Role of Health Care Facilities ".
It includes R. 1221-40 to R. 1221-48 thus written:
" Art. R. 1221-40. -Each health facility, whether public or private, is required to collect and maintain, for each labile blood product unit that is distributed to it or issued to a hospital patient, the following information:
" 1 ° The number Identification of the unit prepared in accordance with the national consolidation approved by the French Health Products Safety Agency;
" 2 ° The identification of the code produced in accordance with the national consolidation approved by This agency;
" 3 ° The circumstances of the transport and storage of the unit;
" 4 ° Identification of the prescriber and the person responsible for administering the labile blood product;
" 5 ° Patient identification To which the unit and the circumstances of this administration have been administered, or, where applicable, the date on which the unit was destroyed or returned to the reference blood establishment;
" 6 ° Where the health facility Issues a labile blood product to a patient hospitalized in another health care facility, the identification of that institution and the date and circumstances of the issue; and
" 7 ° Any adverse reactions in a recipient Of blood components as well as any serious incident.
" Art. R. 1221-41. -At the request of the Agence française de sécurité sanitaire des produits de santé, the health care facility collects and maintains all the information about the hemovigilance that it has access to and which relates to:
" 1 ° Transfusion Preoperative and peroperatory autologous in the institution;
" 2 ° Pre-transfusion and, where appropriate, post-transfusion tests performed on the patient;
" 3 ° The administration, in the context of the same treatment, A drug derived from blood and labile blood product;
" 4 ° The conservation, for future analysis, of biological samples taken from the patient
Art. R. 1221-42. -The establishment of blood transfusion shall send to the health care facility the information relating to the 1 ° and 2 ° of Article R. 1221-40 and, where appropriate, to 2 ° of Article R. 1221-41.
" Decisions of the Director General The Agence française de sécurité sanitaire des produits de santé taken after notification of the French Blood Establishment may specify the content of the information referred to in this Article and determine the details of their collection by the establishment of Health or transmission by blood establishment.
" Art. R. 1221-43. -Within each health institution, public or private, a haemovigilance correspondent is responsible for ensuring:
" 1. The declaration, under the conditions and in the manner provided for in Article R. 1221-49, of any adverse reaction that has occurred In a recipient of labile blood products and any serious incident;
" 2 ° The collection and retention of the information referred to in Articles R. 1221-40 to R. 1221-42, ensuring the quality and reliability of this information ;
" 3 ° Communication to the French Health Products Safety Agency and the Regional Blood Safety Coordinator of the information they seek, pursuant to Article R. 1221-33;
" 4 ° Transmission to The establishment of blood transfusion refers to the information referred to in the first paragraph of Article R. 1221-38;
" 5 ° Reporting to the French Health Products Safety Agency and the Regional Coordinator Hemovigilance of any difficulty that could compromise blood safety;
" 6 ° Investigations to be undertaken in the event of an emergency as a result of adverse reactions in recipients of labile blood products or Serious incidents. In this case, it shall immediately inform the regional coordinator, who decides whether or not to continue the investigation, and the French Health Products Safety
. The Blood Safety Correspondent The health care facility must be a physician. However, the hemovigilance correspondent may be a pharmacist under conditions laid down by order of the Minister responsible for health on the proposal of the Director General of the French Health Products Safety
. Of Special conditions of qualification and training may be imposed on the correspondents of certain establishments by order of the Minister responsible for health, taken on the proposal of the Director General of the French Health Safety Agency Health products.
" The Blood Safety Correspondent shall be designated by the Director of the institution. In public health institutions, it shall be designated after the opinion of the medical establishment
. The name of the correspondent is communicated by the establishment to the French Health Products Safety Agency, at the Regional Blood Safety Coordinator and Referent Blood Transfusion Institution.
" Art. R. 1221-44. -In each health facility, a Transfusion and Blood Safety Committee shall bring together the director of that institution and the director of the blood transfusion establishment or their representatives, the focal points Haemovigilance of these two institutions and representatives of medical, health care, medical and administrative personnel of the health care facility. In particular, the main blood transfusion providers for this institution are represented.
" An internal regulation lays down the arrangements for the composition, organisation and operation of the Committee on Transfusion Safety and Hemovigilance of establishment.
" Art. R. 1221-45. -The mission of the Committee on Transfusion Safety and Blood Safety is to contribute through its studies and proposals to improve the safety of patients who are transfused
It ensures the implementation of the rules And hemovigilance procedures provided for in this section. He is responsible for coordinating hemovigilance activities within the health care facility.
" As such:
" 1 ° It shall ensure to the services responsible for the presence in the medical file referred to in the article R. 1112-2 of the documents relating to the transfusion acts and, where applicable, the copy of the adverse reaction report card in a recipient;
" 2 It shall have before it any matter relating to the cooperation of the correspondents Blood surveillance of the blood establishment and the health care facility, and more generally any questions relating to the transmission circuits of information, with a view to improving the effectiveness of hemovigilance;
" 3 ° Is kept informed of the conditions of the blood depots;
" 4 ° It shall be notified of serious incidents in the health care facility and of adverse reactions in the recipients, and shall design any measures intended to do so Fix;
" 5 ° Presents to the Medical Commission the establishment of a training programme in transfusion safety for the personnel concerned;
" 6 ° He submits an annual report to the Medical Committee Activity.
" Art. R. 1221-46. -The Blood Safety and Blood Safety Committee meets at least three times a year.
" The Regional Blood Safety Coordinator, the Head of the Regional Pharmacovigilance Centre and the focal point within the The establishment of the Regional Pharmacovigilance Centre for Blood Derivatives, if they so wish, attend committee meetings and may be heard.
" Art. R. 1221-47. -The French Health Products Safety Agency, the Regional Blood Safety Coordinator and the prefect of the department are addressed to the reports, reports and other documents relevant to the hemovigilance developed by the committee Transfusion safety and establishment haemovigilance.
" Art. R. 1221-48. -The Committee may refer to the Regional Blood Safety Coordinator and the French Health Products Safety Agency any questions related to the implementation of the haemovigilance rules in the health facility. He or she may ask the regional coordinator to investigate the circumstances of the occurrence of a serious incident or adverse reaction in the health care facility. "
VIII. -In the same section 4, a sub-section 8 shall be set out as follows: Obligation to report and report ".
It includes R. 1221-49 to R. 1221-52 worded as follows:
" Art. R. 1221-49. -Any health professional who finds or is aware of a serious incident shall report it without delay to the Blood Safety Officer of the Blood Transfusion Institution where the blood donation or the Blood Safety Correspondent has been performed The health care facility where the problem occurred.
" The haemovigilance correspondent conducts the appropriate investigation and examination. It writes a problem declaration form.
" Any health professional who finds or is aware of a serious adverse reaction in a blood donor shall report it without delay to the Blood Safety Correspondent Blood transfusion in which the product was taken.
" The donor conducts the appropriate investigation and review and prepares a report card for an adverse reaction in a donor's file.
" Any health care professional who discovers or is aware of an adverse reaction in a labile blood product recipient shall report it without delay to the haemovigilance of the health care facility in which the Product. Failing to be able to contact him, he shall report it to any haemovigilance of a blood establishment, which transmits this information to the appropriate hemovigilance correspondent.
" The Blood Safety Correspondent The health establishment in which the administration of the product has been administered shall carry out the appropriate investigations and examinations in the service concerned. He shall inform the correspondent of the blood transfusion establishment and shall, in consultation with him, draw up a statement of adverse reaction in a recipient, a copy of which shall be placed on the medical record of the
. If Adverse events that may be due to a labile blood product have appeared in a patient who has also been administered drugs derived from blood or biological products under another vigilance, a copy of the Statement of adverse reaction in this patient is communicated to the appropriate vigilance correspondent.
" Art. R. 1221-50. -The Agence française de sécurité sanitaire des produits de santé and the Regional Blood Safety Coordinator are simultaneously receiving reports of serious incident reports and reports of adverse reactions in a Donor or recipient. The French Blood Establishment and the Blood Transfusion Centre of the Environments are each addressed to the respective declaration sheets.
" Art. R. 1221-51. -A decision by the Director General of the French Health Products Safety Agency fixes, after the opinion of the French blood establishment and the blood transfusion centre of the armies, the form and content of the declaration sheets Serious incidents, as well as reports of adverse reactions in a donor or recipient, and the manner in which they are transmitted. This decision may define the cases and situations where the record is to be transmitted.
" Art. R. 1221-52. -The provisions of this Section shall apply to biomedical research on blood components, without prejudice to the provisions of Title II of Book I of Part I of this Code. "
Section 5 of the same chapter is entitled " Application to the Environmental Health Service ".
It includes an article D. 1221-53 worded as follows:
" Art. D. 1221-53. -For the purposes of the provisions of Sections 1 to 4 of this Chapter, the hospitals of the armies and the blood transfusion centre of the armies shall, except in the field of external operations, be regarded as health facilities And as a blood establishment. "
Section 6 of the same chapter is entitled: " Pharmacists who are responsible for the surveillance of certain blood components in blood establishments. "
It includes R. 1221-54 and R. 1221-55 written:
" Art. R. 1221-54. -Pharmacists who are responsible under Article L. 1221-10 for the surveillance of blood components intended for direct therapeutic use in blood establishments should be included in Section D of the The National Order of Pharmacists or Section E if they are in an overseas department or in the territorial community of Saint-Pierre-et-Miquelon
Art. R. 1221-55. -Pharmacists in health care facilities, when they are responsible for the surveillance of a blood deposit referred to in section R. 1221-20, must be enrolled in Section D of the National Pharmacists' Order for this activity, Even if they are already enrolled in another section or section E if they are in an overseas department or in the territorial community of Saint-Pierre-et-Miquelon. "
Chapter II of Title II of Book II of the first part of the code of public health (regulations) is amended as follows:
I.-In section 1, after sub-section 2, it is inserted A new sub-section 3 entitled " Person responsible ", which includes R. 1222-9-1 to R. 1222-9-5 thus written:
" Art. R. 1222-9-1. -The person responsible for compliance with the regulations concerning the quality and safety of blood products in blood establishments referred to in Article L. 1222-2 shall be responsible for:
" -ensure that each unit of Blood or blood components, regardless of its intended use, is collected, controlled and, where it is intended for transfusion, prepared, preserved, distributed or issued in accordance with legislative provisions and Current regulations;
" -to communicate to the French Health Products Safety Agency information on the accreditation of blood establishments referred to in Article L. 1223-2;
" -to ensure The establishment, evaluation and updating of the quality assurance system in accordance with the good practices referred to in Article L. 1223-3;
" -take the necessary measures to ensure full traceability of products Blood components regardless of their destination;
" -to establish the haemovigilance device within the French Blood Establishment and to ensure the application of the relevant procedures.
" The responsible person gives Instructions to the Directors of Blood Establishments and Blood Safety Correspondents for the implementation of the provisions of this Article
This person may be the President of the French Establishment Of the blood provided that it meets the qualifying conditions set out in R. 1222-9-2. In this case, the appointment order of that President expressly provides for it.
" Art. R. 1222-9-2. -The responsible person must comply with the conditions of practice of medicine or pharmacy and justify, in the field of blood transfusion, a practical experience of at least two years acquired in one or more establishments of Blood transfusion.
" Art. R. 1222-9-3. -The President of the French Blood Establishment designates at the same time as the person responsible for one or more acting persons. The acting person shall be given the same powers and duties as the person in charge for the replacement period and shall exercise them effectively for the duration of the
. The Person Acting manager must meet the qualification and experience requirements referred to in R. 1222-9-2.
" Art. R. 1222-9-4. -The President of the French Blood Establishment sends to the Director General of the French Health Products Safety Agency copies of any act designating the responsible person and responsible persons Acting.
" When the person responsible is temporarily replaced, the President of the French Blood Establishment shall immediately notify the Director General of the Agency of the person's name and date of taking office Acting manager he has designated.
" Art. R. 1222-9-5. -For the application of this sub-section to the blood transfusion centre of the armed forces, the responsibilities and tasks assigned to the responsible person shall be provided by the director of that centre. "
II. -In the same section 1, sub-section 3: Scientific Council " And subsection 4: " Budget and accounting organisation " Become sub-section 4, respectively: Scientific Council " And subsection 5: " Budget Organization ".
III. -Section 2 of the same Chapter II of Title II of Book II of Part I of the Code of Public Health (Regulations) is thus amended:
1 ° In subsection 1 of this section, it is added to section R. 1222-19 before The words: " The Nurses " The words: " Only physicians, ".
2 ° Section 2 of the same section is amended as follows:
-the heading of this subsection is amended as follows: Distribution and delivery of blood products Labile " ;
-Article R. 1222-23 is replaced by the following:
" Art. R. 1222-23. -Only under the authority of a doctor or a pharmacist may the functions of distributing and dispensing blood components defined in Article R. 1221-17:
" 1 ° Nurses;
" 2 ° People Authorised to be employed as a technician in a laboratory for the analysis of medical biology under the provisions of Articles 4 and 26-1 of Decree No. 76-1004 of 4 November 1976 laying down the conditions for the authorisation of laboratories Medical biology analysis;
" 3 ° Persons with a biological license;
" 4 ° Midwives. "
3 ° In subsection 3 of the same section, the first paragraph of Article R. 1222-27 is amended as follows: the word" Storage " Is replaced by the word: " Conservation " And, after the word: " Pharmacist ", are added the words:" Or a Person with an engineering degree or a national graduate degree in higher education in life sciences, chemistry or physics ".
4 ° In sub-section 4 of the same section, Article R. 1222-28 is replaced by The following provisions: " Persons who, on the one hand, meet the conditions of practice of medicine or pharmacy, or have an engineering degree or a national postgraduate degree in higher education in science Life, chemistry, physics or quality, and which, on the other hand, justify a two-year experience at least in the insurance or quality control sector and have received clearance following a theoretical and practical training Adjustment to employment in accordance with the good practices referred to in Article L. 1223-3; ".
5 ° In sub-section 5 of the same section, the last sentence of the second subparagraph of Article R. 1222-31 reads as
: They must In addition to possessing or acquiring within two years of their appointment the university degree of blood transfusion, or the capacity in transfusion technology, or the diploma of complementary specialized studies of haematology-transfusion. "
Section 2 of Chapter III of Title II of Book II of Part I of the Code of Public Health (Regulations) is amended as follows:
I.-The title of the section is amended as follows: Follows: " Establishment Licensing and Inspection ".
II. Article R. 1223-4 reads as follows:
" Art. R. 1223-4. -The decision of the Director General of the French Agency for Health Product Safety on the application for approval or renewal of the authorisation shall take place within three months from the date of receipt of the application Accompanied by a complete and admissible file. In the absence of a reply to the expiry of that period, the authorisation shall be deemed to be refused in the case of an application for authorisation, and deemed to have been granted in the terms of the previous authorisation in the case of an application for renewal
The decision on Of the transfusion activities referred to in Article L. 1223-2, those which may be carried out by the blood establishment and the site (s) attached to that establishment in which those activities Can be distributed.
" Approval shall be granted for a period of five years from the date of the decision. It is renewable for an identical duration. "
III. -After R. 1223-4 are inserted sections R. 1223-4-1, R. 1223-4-2 and R. 1223-4-3 thus written:
" Art. R. 1223-4-1. -Are subject to the prior written authorisation of the Director General of the French Health Products Safety Agency any changes to the elements of the approval relating to:
" -to a new transfusion activity;
" - The premises in which these activities are carried out and the technical equipment subject to a qualification in accordance with the good practices referred to in Article L. 1223-3 when these modifications of premises or equipment result in a Change in number of people received or products used;
" -the creation of new premises in which the approved activities are performed.
" The decision of the Director General shall take place within three months of Of the date of receipt of the application accompanied by a complete and admissible file. In the absence of a response to the expiry of that period, the authorization to amend is deemed to have been refused. The amendment of the approval does not extend the duration of the initial authorisation granted.
" Art. R. 1223-4-2. -Subject to declaration all changes relating to:
" -the name or address of the registered office of the blood transfusion establishment receiving the approval;
" -the appointment of the Director of the Blood Establishment Blood;
" -the appointment of new persons responsible for the activities referred to in R. 1223-8 et seq. In the blood establishment;
" -the elimination of a transfusion activity and the Closure of a site in which this activity is carried out in accordance with the patterns of organisation of blood transfusion;
" -the preparation of labile blood products implementing new technology;
" -to the distribution Or the delivery of blood components by the blood establishment to a new blood deposit;
" -the implementation of new medico-technical software used for authorized activities;
" -to all Change in the procedures put in place to ensure continuity of the transfusional public service.
" The declaration shall be made no later than the month following the implementation of the amendments referred to in R. 1223-4-1. It is addressed by the President of the French Blood Establishment to the Director General of the French Health Products Safety Agency, accompanied by a letter explaining the subject matter and the possible impact of the amendment On authorized activities. The Director General shall notify the President of the French Blood Establishment of the receipt of the declaration. The Director General of the Agency may request additional information from the applicant on the declaration.
" Art. R. 1223-4-3. -Amendments other than those subject to authorisation or declaration shall be described in the annual statement of activity provided for in Article R. 1223-8. "
IV. -Article R. 1223-6 is amended as follows:
In the first paragraph, after the words: The period laid down in the first paragraph of Article R. 1223-4 " Are added the words: " And the second paragraph of Article R. 1223-4-1. "
V.-After R. 1223-7, it is inserted an R. 1223-7-1 worded as follows:
" Art. R. 1223-7-1. -The Agence française de sécurité sanitaire des produits de santé diligently conducts inspections of blood establishments at a rate at least two years in order to ensure that blood transfusion activities are in conformity with Establishment with good practices and compliance with the operating standards and equipment applicable to them. The Director General of the Agency may request that all necessary information be given to this effect from the blood establishment. "
Subsections 1 and 2 of Section 3 of Chapter III of Title II of Book II of Part I of the Code of Public Health (Regulatory Party) are amended as follows:
I.-Article R. 1223-8 is Thus written:
" Art. R. 1223-8. -The collection of blood and its components, their biological qualification, the preparation, processing, distribution and dispensing of blood components shall be carried out in accordance with good practices defined by the decision of the Director-General of the French Health Products Safety Agency, taken pursuant to Article L. 1223-3. For each of these activities and on each of the sites where they are carried out, the blood establishment shall assign personnel with the required qualifications pursuant to Article L. 1222-10, to dispose of the equipment provided for By good practice for each of the blood transfusion activities and meet the operating standards set out in this section.
" The French Blood Establishment and the Blood Transfusion Center of the Armies address each Year to the Director General of the French Health Products Safety Agency, for each of their establishments, a state of activity whose form and content are fixed by order of the Minister responsible for health on the proposal of the Director General of the Agency. "
II. -The first and second paragraph of Article R. 1223-10 reads as follows:
" Personnel who team the total blood samples at a fixed or mobile site must at least understand, within each team, in addition to the presence of the Less a physician, a person authorized to collect and meet the conditions set out in R. 1222-18. Any team of three or more persons performing the total blood sampling at a fixed or mobile site must include, in addition to the presence of a physician, at least one nurse or nurse
Personnel who take the samples from Blood products by apheresis or in view of stationary or mobile autologous samples must include within each team, in addition to the presence of at least one physician, one or more nurses. "
III. -In Article R. 1223-11, the words: A laboratory framework and " Are deleted.
IV. Article R. 1223-12 reads as follows:
" Art. R. 1223-12. -In order to carry out the laboratory activity of immunohaematology, the establishment of blood transfusion must have, at each site in which this activity is carried out, technicians, in accordance with the rules laid down for the good Carrying out analyses pursuant to Article L. 6213-2, placed under the responsibility of a doctor or pharmacist with the qualifications required by Article L. 1222-10. These technicians can, depending on the volume of laboratory analysis activity, intervene in another laboratory on the site. The institution must also have a separate laboratory in each of the sites involved in the donation-hematology laboratory. "
V.-The last three paragraphs of R. 1223-13 are replaced by the following:
" For distribution, dispensing, transfusional board and, where appropriate, immunohematology laboratory, 24 hours a day, by the establishment of a blood transfusion.
" For the distribution and delivery activity, and on each site, the permanence on site 24 hours on 24 or in the absence of stand-by availability shall be provided by a doctor, a pharmacist, a biological licence holder, a nurse or a laboratory technician with the qualifications provided for in Article L. 1222-10. At least one physician shall provide twenty-four hours a day, on a periodic basis, on a periodic basis, on the part of the Board of
. For the activity of immuno-hematology, and on each site, the permanence on site 24 hours on 24 or in the absence of a stand-by availability shall be provided by a person having the qualifications provided for in the second subparagraph of Article R. 1222-31 and by a laboratory technician with the qualifications provided for in the Article L. 1222-10.
" Subject to the conclusion of a written contract, this permanence may, where appropriate, be arranged in collaboration with a health institution. "
VI. -Article R. 1223-14:
At the c of 2 °, the words: " Cell and gene therapy products " Are replaced by the words: " Preparation of gene therapy and cell therapy ".
The 2 ° is completed by a" F " Read as follows: (f) Lactarium ".
Section 5 of Chapter III of Title II of Book II of the first part of the code of public health (regulations) is thus amended:
I. Article R. 1223-30 reads as follows:
" The The director of the centre, chosen from among the doctors of the armed forces meeting the conditions laid down in Article R. 1222-9-2, shall be appointed by the Minister of Defence, after the opinion of the Minister responsible for health. "
II. -Article R. 1223-31 reads as follows:
1 ° reads as follows: The conditions for the preparation, preservation, distribution and delivery of blood components. "
The 2 ° is completed with the following sentence:
" The Agence française de sécurité sanitaire des produits de santé diligently conducts inspections of blood establishments at at least a biennial rate. The Director General of the Agency may request that all necessary information be given to this effect from the blood establishment. "
The last paragraph is replaced by the following:
" The Director General of the French Health Products Safety Agency sends a copy of the inspection report to the Minister of Defence and to the Minister responsible for Health. "
The provisions set out in section 4 of this Order may be amended by Order in Council.
Done at Paris, 1 February 2006.
Dominique de Villepin
By the Prime Minister:
The Minister of Health and Solidarities,
Xavier Bertrand
Minister of Defence,
Michèle Alliot-Marie
