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Law No. 282 Of 5 October 2005

Original Language Title:  LEGE nr. 282 din 5 octombrie 2005

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LEGE no. 282 282 of 5 October 2005 (* republished *) on the organization of blood transfusion activity, blood donation and blood components of human origin, as well as quality assurance and health security, with a view to their therapeutic use *)
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 188 188 of 17 March 2014



--------- Note * *) Republicated pursuant to art. 248 248 of Law no. 187/2012 for the implementation of Law no. 286/2009 on the Criminal Code, published in the Official Gazette of Romania, Part I, no. 757 of 12 November 2012, corrected in the Official Gazette of Romania, Part I, no. 117 117 of 1 March 2013, giving the texts a new numbering. Law no. 282/2005 was published in the Official Gazette of Romania, Part I, no. 915 of 13 October 2005 and has been amended and supplemented by: - Government Emergency Ordinance no. 7/2006 for amendment Law no. 282/2005 on the organization of blood transfusion activity, blood donation and blood components of human origin, as well as quality assurance and health security, for their therapeutic use, published in the Official Gazette of Romania, Part I, no. 163 of 21 February 2006, approved with amendments by Law no. 434/2006 , published in the Official Gazette of Romania, Part I, no. 973 973 of 5 December 2006; - Law no. 37/2008 for completion Law no. 282/2005 on the organization of blood transfusion activity, blood donation and blood components of human origin, as well as quality assurance and health security, for their therapeutic use, published in the Official Gazette of Romania, Part I, no. 227 227 of 25 March 2008. + Chapter I General provisions + Article 1 (1) This law establishes the legal framework for blood transfusion activity, blood donation and blood components of human origin. (2) This law regulates the rules to ensure the quality and security of blood and human blood components, in order to maintain a high level of protection of the population's health. + Article 2 ((1) The introduction or removal from the country of blood, plasma and other human blood components, as well as human blood products can be done only on the basis of the special authorization of the Ministry of Health, at the proposal of the National Institute of Blood Transfusion "Prof. Dr. C.T. Nicolau" Bucharest, without prejudice to stocks in the national reserve. (2) The authorized and accredited institutions of the Ministry of National Defence will inform the Ministry of Health about the organization and conduct of this type of activities required by the need to solve specific aspects of transfusion activity in the units of this ministry, except those provided in par. ((1). + Article 3 ((1) This law applies to the collection, biological control of blood and human blood components, preparation, storage, distribution and administration thereof. ((2) If blood or human blood components are collected and biologically controlled for use exclusively in autologous transfusion and are clearly identified as such, the conditions to be met are those set out in the Annex. No. 4 lit. g). ((3) This law does not apply to blood cells. + Article 4 This law promotes the following principles: a) blood is a national resource; b) the blood transfusion activity is of the non-profit type, the donation of blood and human blood components being realized only in this framework; c) blood donation is a voluntary, anonymous and unpaid act; d) the realization of self-sufficiency of blood and human blood components is a national priority objective of health policy, under the conditions of optimal and rational therapeutic use, in accordance with the modern practice of transfusion therapy; e) national standards ensure an equivalent level of security and quality for blood and human blood components, irrespective of their origin or intended purpose; f) therapeutic administration of blood or human blood components is a medical intervention indicated and prescribed by a doctor; this activity is carried out under responsibility and medical supervision only in authorized medical facilities in this respect. + Article 5 The definitions of the terms and expressions used in the law are set out in Annex no. 1. + Chapter II Competent authority + Article 6 Blood transfusion activity is organized and controlled by the Ministry of Health, as competent authority. + Article 7 (1) The Ministry of Health exercises its prerogatives through the following structures: a) The National Institute of Blood Transfusion "Prof. Dr. C.T. Nicolau" Bucharest and the territorial blood transfusion centers; b) State health inspection; c) blood transfusion units in hospitals. (2) In order to fulfill its duties, the Ministry of Health reorganizes the National Institute of Transfusion Hematology "Prof. Dr. C.T. Nicolau" Bucharest in the National Institute of Blood Transfusion "Prof. Dr. C.T. Nicolau" Bucharest, hereinafter referred to as I.N.T.S. + Article 8 (1) The organization and functioning of the National Blood Transfusion System shall be approved by Government decision. (2) The organization, functioning, responsibilities and tasks of the competent authority and of the State Health Inspection in the field of blood transfusion are provided in Annexes no. 2 2 and 3. + Article 9 (1) The Ministry of Health authorizes the functioning of I.N.T.S., the county blood transfusion centers and the city of Bucharest, the blood transfusion units in hospitals and the activities that can be carried out. (2) Authorization of the institutions provided in par. (1) is made on the basis of specific norms *) approved by order of the Minister of Health ---------- Note * *) See Order of Health Minister no. 607/2013 for the approval of the Specific Rules on the authorization of blood transfusion units from health facilities, published in the Official Gazette of Romania, Part I, no. 281 281 of 20 May 2013. (3) The Ministry of Health determines the activities that can be carried out by the institutions provided in (1), after verifying compliance with the provisions of the (4) I.N.T.S., the county blood transfusion centers and the Bucharest municipality and the blood transfusion units in hospitals cannot bring any changes to the activities carried out without the written and prior approval of the Ministry of Health. + Article 10 The Ministry of Health organizes, in the National Blood Transfusion System and in the blood transfusion units in hospitals, inspections and control measures to ensure compliance with the provisions of this law. + Article 11 (1) The Minister of Health temporarily suspends or withdraws the operating authorization or carrying out activities of I.N.T.S., county blood transfusion centers and Bucharest municipality and blood transfusion units in hospitals, whether an inspection or other means of control has proved that these institutions do not comply with the legal provisions. (2) The situations in which the authorization to operate the institutions referred to in par. (1) are approved by order of the Minister of Health. + Chapter III Blood donation + Article 12 (1) I.N.T.S. and the county blood transfusion centers and the city of Bucharest take all necessary measures to provide potential blood donors and human blood components, ensuring confidentiality from any information provided. authorized personnel, relating to their health status, to the results of their donation testing and to any future identification by a third party, except as required by law. ((2) Potentials blood donors or human blood components shall be provided with the necessary information according to Annex no. 4 lit. b). + Article 13 I.N.T.S. and the county blood transfusion centers and the city of Bucharest take all necessary measures so that all donors in Romania who manifest their desire to perform a blood donation or human blood components provide information set out in Annex no. 4 lit. c). + Article 14 I.N.T.S. and the county blood transfusion centers and the city of Bucharest will ensure that blood donors and human blood components correspond to the eligibility criteria established according to the norms set out in Annex no. 4 lit. d). + Article 15 (1) The ministries, the other central and local bodies of the public administration, the county public health departments and the city of Bucharest, as well as the cultural, broadcasting and television institutions are obliged to support the actions of promotion organized for the purpose of blood donation and human blood components, according to the skills they have. (2) The Romanian Broadcasting Society, the Romanian Television Society and the Ministry of National Education promote the humanitarian campaigns of blood donation, at national level. (3) Mayors are required to support all actions to promote donation and blood collection and human blood components, by making available means of information to the population and suitable locations for mobile teams. harvesting. (4) I.N.T.S. and the county blood transfusion centers and the city of Bucharest organize information, education and communication campaigns for health in the field of blood transfusion, in collaboration with the county public health departments and the Bucharest. ((5) The expenses for carrying out the mentioned actions intended to contribute to the education and information of citizens for the purpose of voluntary blood donation or on the way of harvesting and testing of blood products will be made from the amounts provided annually in the budget of the Ministry of Health to promote blood donation. ((6) Promoting blood donation through the press, radio and television stations is free of charge. + Article 16 Blood donation is carried out both within the county blood transfusion centers and the city of Bucharest, as well as within the mobile units belonging to the blood collection centers, properly equipped, which move in order to Blood harvesting from potential donors. + Article 17 (1) Blood donors have the right to receive, at each donation, a food allowance in the form of meal vouchers, which have the physical and value characteristics provided by Law no. 142/1998 on the granting of meal tickets, with subsequent amendments and completions, or a postdonation meal at the blood transfusion center in the equivalent of the total value of the meal tickets granted. (2) The number of meal vouchers, as well as other rights and obligations of blood donors shall be determined by Government decision. (3) The expenses related to the rights referred to in ((1) shall be borne: a) in 2006, from the local budgets of the localities where the profile institutions with blood harvesting activity for transfusion purposes are based; b) as of January 1, 2007, from the state budget through the budget of the Ministry of Health. (4) In application of paragraph (1) and (3), the Ministry of Health shall develop norms approved by order *) of the Minister of Health with the opinion of the Ministry of Labour, Family, Social Protection and Elderly and the Ministry of Public Finance. --------- Note * *) See Order of Public Health Minister no. 441/2007 for the approval of the implementing rules art. 16 16 of Law no. 282/2005 on the organization of blood transfusion activity, blood donation and blood components of human origin, as well as quality assurance and health security, with a view to their therapeutic use, with subsequent amendments and completions, published in the Official Gazette of Romania, Part I, no. 248 248 of 13 April 2007. + Chapter IV Privacy and data protection + Article 18 (1) The Ministry of Health shall take all necessary measures so that the data, including genetic information, which are obtained under this law and to which a third person has access, shall become confidential so that the donor cannot be identified. (2) For the purpose provided in par. (1) I.N.T.S. and the county blood transfusion centers and the city of Bucharest shall take measures to: a) the realization of databases; b) ensuring data security and prohibiting any unauthorized changes in donor files or exclusion registers; c) prohibition of unauthorized transfer of information; d) the introduction of procedures to resolve any discrepancy between the data; e) guarantee the traceability of donations, aiming at no unauthorized disclosure. + Article 19 The system for reporting information and data to the competent institutions to which the collection and monitoring of epidemiological data is assigned shall be established by order of the Minister of Health. + Chapter V Quality Management + Article 20 I.N.T.S. designates at the level of the county blood transfusion centers and of the city of Bucharest a person, hereinafter referred to as the responsible person, who has the following duties: a) to guarantee compliance with the legal provisions in force regarding donation, harvesting, biological control, preparation, preservation and distribution for each unit of blood or blood component; b) the transmission to the Ministry of Health of the information necessary for the authorization procedure; c) the application of the provisions of the present law regarding the qualification of the personnel and the quality management system at the level + Article 21 (. The responsible person must meet the following minimum conditions of professional training: a) to be the holder of a university degree in the field of medical sciences or a university training cycle in these fields, recognized in Romania; b) post-university practical experience of at least 2 years in the respective fields, acquired in one or more authorized and accredited institutions to carry out harvesting, testing, preparation, storage and distribution activities. (2) The attributions provided in art. 20 may be delegated to other persons with the same qualification as the person responsible. + Article 22 (1) I.N.T.S. and the county blood transfusion centers and the city of Bucharest communicate to the Ministry of Health the name of the responsible person provided in art. 20 or other persons delegated, according to art. 21 21 para. (2), and information on the specific tasks it must perform, according to the job description. (. If the person responsible or the delegated persons are temporarily replaced or definitively replaced, the institution shall immediately communicate to the Ministry of Health the name of the new person responsible and the date from which this replacement is made + Article 23 The collection of blood and human blood components is only done under supervision and medical responsibility. + Article 24 Personnel involved in the establishment of admission to donation, collection, biological control, preparation, preservation, distribution and administration of blood and human blood components hold the necessary qualifications for the execution of these tasks and benefit appropriate and permanently updated training, according to the requirements established by the Ministry of Health, by order of the Minister of Health. + Article 25 (1) Each unit of blood or human blood components is biologically controlled according to the legal provisions in force, which guarantee that all necessary measures have been taken to protect the health of people who receive blood or human blood components. (2) Basic requirements on biological control, practiced on blood donations or human blood components, including autologous blood donations, shall be established by order of the Minister of Health. + Article 26 I.N.T.S. and the county blood transfusion centers and the city of Bucharest have the obligation to ensure and verify compliance with the specific conditions of preservation of blood and human blood components in all stages of activity, from the moment of collection until the time of their distribution and transport, as set out in Annex no. 4 lit. e). + Article 27 I.N.T.S. and the county blood transfusion centers and the city of Bucharest have the obligation to ensure the conformity of quality and safety of blood and human blood components with the requirements set out in Annex no. 4 lit. f). + Article 28 The frequency of donations and the maximum volume collected at each donation are approved by order of the Minister of Health. + Chapter VI Therapeutic use of blood and human blood components + Article 29 (1) Blood and human blood components will be distributed by I.N.T.S. through the county blood transfusion centers and the city of Bucharest, with reimbursement in non-profit system, at the request of healthcare institutions with units of authorized transfusion from the territory of arondat. (2) The blood products obtained from the plasma processing can be issued, for a fee, to healthcare institutions or directly to the population, on prescription. ((3) The contravail of a blood unit, of human blood components, as well as of blood products obtained from plasma processing will be established by order *) of the Minister of Health. ---------- Note * *) See Order of Health Minister no. 1.057/2011 on the updating of tariffs for laboratory tests carried out by the National Institute of Transfusion Hematology and the blood transfusion network, published in the Official Gazette of Romania, Part I, no. 454 454 of 29 June 2011. + Article 30 (1) The therapeutic administration of blood and human blood components to patients admitted to hospitals is done only after performing immunohematological tests, mandatory for the transfusion act, established by specific norms approved by order of the Minister of Health (2) The activity of the blood transfusion units in the hospital is carried out under the responsibility of a doctor with qualification in the field of blood transfusion, designated by the hospital management. + Article 31 ((1) Blood and human blood components can only be administered on the basis of a medical prescription, resulting from a complete medical examination and for therapeutic purposes only. ((2) The responsibility of prescribing and administering blood and human blood components shall be with the patient's treating physician. ((3) The clinical indications of blood transfusion and human blood components are established on the basis of the National Guidelines for the rational therapeutic use of blood and human blood components, approved by order * *) of the Minister of Health. ---------- Note ** **) See Order of Public Health Minister no. 1.343/2007 for the approval of the National Guide for the rational therapeutic use of blood and human blood components, published in the Official Gazette of Romania, Part I, no. 569 569 of 20 August 2007. (4) For the purpose of administration of transfusion therapy, the attending physician shall ensure that the patient is informed of this medical act and obtain his written consent. (5) Following transfusion therapy the patient is informed in writing of the transfusion act performed. + Article 32 The provisions of this law also apply accordingly to blood transfusion units in hospitals, according to their duties and competences. + Chapter VII System of haemovigilance + Article 33 (1) The Ministry of Health organises the National Hemovigilance System. * **) -------- Note *** ***) See Order of Public Health Minister no. 1.228/2006 for the approval of the Rules on the organisation of the system of haemovigilance, traceability assurance as well as the Regulation on the Registration and Reporting System in the event of incidents and severe adverse reactions related to the collection and administration of blood and human blood components, published in the Official Gazette of Romania, Part I, no. 870 of 24 October 2006, with subsequent amendments and completions. (2) The organizational structure, responsibilities and duties of the medical institutions involved, as well as the registration and reporting system in case of occurrence of incidents and adverse reactions related to the collection and administration of blood and components human blood is established by regulation approved by order of the Minister of Health. (3) The Ministry of Health will organize inspections and other control measures in case of occurrence or suspicion of any severe adverse reaction or any severe adverse incident. (4) In order to maintain and improve transfusion security, the Ministry of Health shall develop procedures for the verification and evaluation of the reported information and the measures taken, in order to prevent the occurrence of similar reactions + Article 34 I.N.T.S. elaborates and introduces at the level of the county blood transfusion centers and the city of Bucharest a specific procedure that allows with precision, effectiveness and in a verifiable way the blocking of distribution and the recall in order withdrawal of blood and human blood components associated with a severe incident or severe adverse reaction, in compliance with the provisions laid down in Annex no. 4 lit. i). + Article 35 (1) I.N.T.S. and the county blood transfusion centers and the city of Bucharest have the obligation to ensure, for each stage of their own activity, the traceability of blood and human blood components collected or prepared, from the moment determining the donor's eligibility by the time of distribution and transport to the final destination. (2) Blood transfusion units in hospitals have the obligation to ensure, for each stage of their own activity, the traceability of blood and human blood components received, from the moment of their reception until the moment of realization of the act transfusional to the receiving patient. + Article 36 (1) In order to ensure traceability, the Ministry of Health shall develop and introduce the national single system for the identification of each blood donation, of each unit of blood and human blood components collected or prepared, by adopting rules set out in Annex no. 4 lit. a). (2) The state health inspection checks, at the level of the national blood transfusion system, the introduction and observance of the national single system of identification of each blood donation and of each blood unit and human blood components collected or prepared, to guarantee traceability from the donor to the recipient and from the recipient to the donor. + Article 37 The Ministry of Health shall take all necessary measures to ensure the introduction and use of the blood-labelling system and the collected, biologically controlled, prepared and preserved human blood components, which are distributed in the territory, in accordance with the single national identification system and the labelling requirements laid down in the rules of approval by order of the Minister of Health. + Article 38 The data necessary to ensure traceability are kept at the level of I.N.T.S., the county blood transfusion centers and the city of Bucharest and the transfusion units in hospitals, at least 30 years. + Chapter VIII Sanctions + Article 39 Violation of the provisions of this law attracts disciplinary, material, civil, contravention or criminal liability, as appropriate. + Article 40 They constitute crimes and are punishable by imprisonment from 6 months to 3 years or with a fine the following facts: a) the intentional non-declaration by the donor of communicable diseases or known risk factors, after prior information in the medical examination; b) the collection of blood from a person without the consent of the person; c) blood collection from a minor or from a major person without discernment, outside of specific medical indications established by the attending physician; d) the organization of transfusion activity in order to obtain material advantages by harnessing the blood and human blood components; e) the distribution and use of blood and human blood components without regular biological control and validation procedure; f) performing activities related to the donation, collection, biological control, preparation, distribution and administration of blood and human blood components, without authorization from the Ministry of Health or under conditions other than those provided for in the legal authorization or without accreditation for those activities; g) modification of the biological characteristics of a person's blood, before the harvest, without its consent. + Article 41 The following facts are contraventions: a) disclosure of information enabling the identification of the donor and the recipient; b) the distribution of blood or human blood components at a price different from that established legally; c) blood donation in order to obtain material advantages or for the purpose of marketing donated blood or human blood components; d) the distribution of a human blood component not in the national nomenclature approved by the competent authority + Article 42 (1) Contraventions provided in art. 41 is sanctioned with a fine of 500 lei to 1,500 lei. ((2) Sanctions shall also apply to legal persons. (3) The finding of contraventions and the application of sanctions shall be made by persons empowered with inspection tasks, designated by the competent authority. + Article 43 Provisions relating to contraventions provided for in art. 41 is completed with the provisions of Government Ordinance no. 2/2001 on the legal regime of contraventions, approved with amendments and additions by Law no. 180/2002 , with subsequent amendments and completions, as well as with the provisions Government Decision *) no. 857/2011 ** **) on the establishment and sanctioning of contraventions to public health norms. ---------- Note * *) See Law no. 254/2010 for repeal Law no. 98/1994 on the establishment and sanctioning of contraventions to the legal norms of hygiene and public health, published in the Official Gazette of Romania, Part I, no. 848 848 of 17 December 2010. Note ** **) Government Decision no. 857/2011 was published in the Official Gazette of Romania, Part I, no. 621 621 of 1 September 2011. + Chapter IX Final provisions + Article 44 Annexes no. 1-4 are an integral part of this law. + Article 45 This law * **) enters into force 120 days from the date of publication in the Official Gazette of Romania, Part I, except art. 46, which takes effect 3 days from the date of publication in the Official Gazette of Romania, Part I. ---------- Note *** ***) Law no. 282/2005 was published in the Official Gazette of Romania, Part I, no. 915 915 of 13 October 2005. + Article 46 (1) Within 60 days from the date of publication of the present law in the Official Gazette of Romania, Part I, the Ministry of Health will develop and submit to the Government a draft Government decision * ***) on the establishment, organization and functioning of the Advisory Committee for the Promotion of Blood Donation. --------- Note **** ****) See Government Decision no. 546/2006 on the establishment, organization and functioning of the Advisory Committee for the Promotion of Blood Donation, published in the Official Gazette of Romania, Part I, no. 389 389 of 5 May 2006. (2) The appointment of the members of the Advisory Committee for the Promotion of Blood Donation will be established by order of the Minister of Health. + Article 47 On the date of entry into force of this Law, Law no. 4/1995 on blood donation, therapeutic use of human blood and transfusion organization in Romania, published in the Official Gazette of Romania, Part I, no. 9 of 19 January 1995, as amended, shall be repealed. + Article 48 This law transposes Directive 2002 /98/EC on quality and security standards for the collection, testing, processing, storage and distribution of human blood and blood components, published in the Official Journal of the European Communities (JOCE) no. L033 of 8 February 2003. + Annex 1 TERMINOLOGY Under the terms of this law, the following terms and expressions have the following meaning: a) blood-venous blood, collected from a single donor, in a sterile and apirogenic device containing anticoagulant; b) blood components-human blood components, as well as erythrocytes, leukocytes, platelets, plasma, which can be obtained by various methods; c) blood product-any therapeutic product obtained from human blood or plasma by industrial-pharmaceutical processing; d) homologous donation-blood collection or blood components from a person for therapeutic use in another person or for industrial-pharmaceutical processing; e) autologous transfusion-blood or blood components, collected from one person, for therapeutic use only in the same person; f) blood transfusion center-any structure or body that is responsible for any stage in the harvesting and testing of blood and human blood components, whatever the intended purpose, and with their processing, preparation and distribution when are intended for transfusion; this definition does not include blood transfusion units in hospitals; g) the county blood transfusion center or the Bucharest municipality-profile institution, public institution with activity in the field of blood transfusion, according to the accreditation granted by the Ministry of Health; h) hospital blood transfusion unit-structure within hospitals, which stores blood and human blood components intended for delivery and therapeutic use exclusively in the services of the hospital where they operate; these units perform the mandatory immunohaematological tests for the transfusion act; i) severe adverse event-any inopportune event related to the collection, biological control, preparation, preservation or distribution of blood and human blood components, likely to cause death or to endanger life, to determine a disability or incapacity of the patient or who causes or prolongs hospitalization or morbidity; j) severe adverse reaction-an unforeseen reaction to the donor or to the patient, related to the collection or transfusion of blood or human blood components, which is deadly, life-threatening, causes disability or incapacity, causes or prolongs hospitalisation or morbidity; k) exclusion of the donor-suspension from the admissibility of a blood donor or blood components; exclusion is temporary or permanent; l) distribution-supply of blood and human blood components to other county blood transfusion centers or the city of Bucharest, blood transfusion units or for industrial processing-pharmaceutical; refers to the delivery of blood or human blood components from the blood transfusion units of a hospital to a ward in the same hospital for therapeutic use; m) traceability-all recorded information and measures that allow the tracking and identification of each stage of activity, starting from the admission of the person to donation to the therapeutic use of blood and blood components human; traceability allows the establishment of a link between the donor and one or more recipients and from the recipient to the donor, being established by means of a single national system for the identification of blood establishments and persons; n) haemovigilance-a set of procedures for the surveillance of undesirable incidents or of severe adverse reactions that occur both to the donor and to the blood recipient, as well as to the surveillance of donor epidemiological methods; o) inspection-official control activity, carried out according to the adopted requirements, in order to assess compliance with the legal provisions in the field, as well as to identify non-conformities; p) self-sufficiency-the provision of national blood and human blood components, under the conditions of rational therapeutic use, in accordance with the modern practice of transfusion therapy; q) quality system-organizational structure, procedures, processes and resources necessary for the implementation of quality management; r) validation-establishing documented and objective evidence that particular requirements for specific use can be fully met; s) authorization-evaluation and analysis process that conditionally and legally condition the commissioning and conduct of certain activities in the field of blood transfusion; s) authorization-technical and legal act issued in writing by the public health authority the component, by which the conditions and/or operating parameters of an activity in the field of transfusion are established; t) blood cells-precursor cells of the human blood cell components. + Annex 2 TASKS Ministry of Health as competent authority In order to comply with the principles provided in 4 of the law, the powers of the Ministry of Health as competent authority are as follows a) elaborates the policy and strategy of sustainable development of the National Blood Transfusion System; b) organize the system and the blood transfusion program based on the objectives of the national policy; c) ensure transparency in the field of blood transfusion; d) ensure the human, financial and technical resources necessary for the functioning of the National Blood Transfusion System, under the conditions of this Law; e) adopt the necessary measures, through its specific structures, to ensure national self-sufficiency of blood and human blood components; f) promotes and ensures compliance with the legal and ethical principles governing the blood transfusion system; g) oversee the use of blood in an optimal and rational way in order to avoid losses; h) establishes the duties, responsibilities, rights and obligations of the structures involved in the implementation of the blood transfusion program; i) develop the rules on the qualifications of personnel, the necessary requirements for ensuring the safety, efficacy and quality of blood and blood components, as well as the information management system; j) adopt the necessary measures for each structure of the national blood transfusion system to introduce and apply a quality system founded on principles of good practice; k) ensures through its competent structures traceability, from donor to recipient and from recipient to donor, blood and human blood components collected, biologically controlled, prepared, preserved, distributed and administered on . l) develop and introduce the unique national system of identification of each blood donation, of each unit of blood and human blood components collected or prepared; m) coordinates the collaboration of all institutions and civil society involved in the promotion and support of blood donation; n) supports and recognizes international solidarity in ensuring blood security worldwide; o) organize the National Hemovigilance System; p) establishes the system of record, reporting, verification and evaluation of reported information on severe adverse reactions and severe incidents related to the collection, preparation, biological control, preservation, distribution and transfusion of blood and human blood components; q) ensures the guarantee of the blood labeling system and human blood components, according to the provisions of this law; r) ensures the elaboration and introduction of a single system for the coding of donor identification data in the reports to the competent institutions to which the collection and monitoring of epidemiological data is assigned. + Annex 3 TASKS State health inspection in the field of blood transfusion In order to apply the provisions of this Law, the duties of the State Health Inspection are as a) organize, whenever necessary, inspections and other control measures in cases of suspicion or in those reporting serious unforeseen incidents and serious adverse reactions, according to the provisions of this law; b) verify the application of laws, regulations and good practices concerning the collection, preparation, biological control, conservation, distribution, therapeutic use and health security of blood and human blood components; c) elaborates, in collaboration with the Transfusion Commission of the Ministry of Health, norms and procedures for the conduct of the transfusion inspection; d) technically control and carry out the necessary technical expertise on the collection of blood and human blood components, preparation, biological control, conservation, distribution and therapeutic use, in order to ensure health security; e) may suspend the activity of health facilities involved in human blood collection, preparation, biological control, preservation, distribution and therapeutic use of blood and human blood components, in case of serious danger or suspicion of serious danger to public health; f) collects the scientific and technical data necessary to carry out its tasks, receives the control reports or the opinions of the expertise carried out in its field of competence by the public institutions of the state; g) participate in the international actions of Romania in its field of competence; h) periodically reports to the Minister of Health and informs the Transfusion Commission of the Ministry of Health, I.N.T.S. and the county blood transfusion centers and of the city of Bucharest on the results of the control activity carried out, statistical and epidemiological data, providing the expertise required in its field of competence; i) develop and submit to the approval of the Ministry of Health the annual control action plan j) to maintain and improve transfusion security, apply the procedures for the verification and evaluation of the reported information and the measures taken in the field of hemovigilance, developed by the Ministry of Health, to prevent the occurrence similar reactions; k) regularly, in the structures of the National Blood Transfusion System and in the blood transfusion units in hospitals, inspections and other measures to control and evaluate the application and compliance with the requirements of this law, to a range not exceeding 2 years; l) designate specialists who carry out inspections and other control measures, having the following duties: -to inspect the organizational structures of the National Blood Transfusion System and blood transfusion units in hospitals; -use standardised control and evaluation procedures; -to take samples for examination and analysis; -verify all the documents to which the objective of the inspection relates; m) take all necessary measures so that the persons responsible for the inspection and other control measures referred to in lett. k) have access to documents. + Annex 4 TECHNICAL RULES By order of the Minister of Health, the following technical rules and their adaptation to scientific and technical progress are approved: a) The rules for ensuring traceability; b) Rules on information to be provided to donors; c) Rules on information to be communicated by donors, including identification data, medical history, as well as the donor's signature; d) The rules on the admissibility of blood donors and human blood components, including the criteria for permanent exclusion and the criteria for temporary exclusion from donation; e) The rules on collection, biological control, preparation, preservation, distribution and transport of blood and human blood components; f) Rules on the quality and security of blood and blood components; g) The rules on autologous transfusion; h) Rules on standards and specifications covered by the legislation in the field, relating to the quality system in a blood transfusion institution; i) the procedures regulated in accordance with the legislation in force, regarding the reporting of serious unforeseen incidents and severe adverse reactions, blocking of distribution and recall for withdrawal; j) National nomenclature of human blood components; k) Rules on the activity of blood transfusion units in hospitals; l) Rules regarding the authorization and accreditation of I.N.T.S., of the county blood transfusion centers and of the city of Bucharest and of the blood transfusion units in hospitals; m) National guide for the rational therapeutic use of blood and human blood components. -------