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Law No. 4 Of 10 January 1995 On Blood Donation, The Therapeutic Use Of Human Blood Transfusion Organization In Romania

Original Language Title:  LEGE nr. 4 din 10 ianuarie 1995 privind donarea de singe, utilizarea terapeutică a sângelui uman şi organizarea transfuzională în România

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LEGE No. 4 of 10 January 1995 on blood donation, therapeutic use of human blood and transfusion organization in Romania
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR NO. 9 of 19 January 1995



The Romanian Parliament adopts this law + Chapter 1 General provisions + Article 1 (1) The donation of blood for therapeutic purposes, intended to contribute to the protection of the health of the population, is a humanitarian gesture, benevol, unpaid and anonymous. (2) The donation of blood is made only by persons who are between 18-65 years of age and who, following the thorough medical examination, do not have medical contraindications or risk factors for diseases of any nature communicable by blood. (3) The harvesting of blood from minor persons or from discerning adults, outside a medical indication, is prohibited. + Article 2 Single donor persons for therapeutic purposes are declared honorary donors of Romania. + Article 3 (1) Transfusion activity based on profit, which would be realized on account of blood, plasma and blood derivatives of human origin, is prohibited. (2) The harvesting of blood as a result of the exercise of a constraint of a physical or moral nature on a person is prohibited. + Chapter 2 Blood donation + Article 4 The transfusion activity in Romania is organized and controlled by the Ministry of Health through its specialized units. + Article 5 In the activity of harvesting, preserving and distributing human blood and products derived from blood, the Ministry of Health has the following obligations: a) organize, guide and control the activity of harvesting, preparation and preservation of the human blood and its derivatives, carried out through its authorized specialized units; b) establishes the forecast for the annual blood needs based on the proposals made by the territorial sanitary directions through the blood transfusion centers; c) ensure, through specialized units and other health facilities, epidemiological and clinical control of blood donors, laboratory control of the blood collected, according to the instructions of the Ministry of Health, in order to ensure quality d) guide and control the use for therapeutic and diagnostic purposes of the blood and its derivatives, aiming at the application of the most appropriate measures to avoid posttransfusion reactions and the transmission of any infections; e) organize the activity of establishing the blood group of citizens, in order to register it, under the law, in the identity card; f) ensure the supply of human blood and its derivatives for special situations; g) organizes the involvement of doctors and health personnel in actions on attracting new honorary donors of blood; h) retooled and equips the blood transfusion centers with modern equipment specific to their activity, including computer science, to carry out their activity at optimal parameters. + Article 6 (1) The harvesting of the human blood or plasma for therapeutic purposes may be carried out, at the premises or by mobile teams, only by the specialized health facilities for this activity, based on operating permits issued by the Ministry Health and the Ministry of National Defence, respectively, for the units subordinated to it. (2) The separation, processing and preservation of blood or plasma, as well as blood or plasma derivatives shall be carried out by specialized institutions, authorized by the Ministry of Health. ((3) Plasmapheresis is carried out under technical conditions that are established by the Ministry of Health, by regulation elaborated for this purpose. + Article 7 (1) The harvesting and preservation of blood and plasma are made according to the instructions of the Ministry of Health. (2) The collection of blood and plasma will be done only under supervision and medical responsibility. (3) The frequency of donations and the quantities taken at each donation are established by regulations of the Ministry of Health. Blood sampling at a donation will be 5-7 ml/kg body weight donor, but not more than 450 ml. + Article 8 (1) The introduction or removal from the country of human blood, as well as products derived from blood or plasma may be made only on the basis of the special authorization of the Ministry of Health, for each lot, without prejudice to stocks in reserve national. (2) The profile institutions of the Ministry of National Defence, authorized by the Ministry of Health, will inform on the organization and conduct of this type of activities required by the need to solve specific aspects of the activity transfusion from the units of this ministry. + Article 9 In order to obtain products derived from singe with specific diagnostic or therapeutic action, immunization of donors with foreign antigens is subject to Instructions of the Ministry of Health. Immunization can only be done with the written consent of the donor, after he became aware of her goals and risks. + Article 10 (1) Honorary blood donors, as well as plasma donors by plasmapheresis benefit, on request, for each actual donation, from the following: a) a meal at the blood transfusion center or a non-refundable meal voucher at a restaurant or vouchers for food products, at the level of the legal allowance; b) for each fifth donation, of a reward in the form of vouchers for food products, provided that these donations are made in 2 consecutive years and within the frequency limits and in quantities taken according to the provisions this law; c) 2 days off from work, including the day of donation, for employees assigned to public institutions, as well as to other legal entities; d) 2 consecutive days exemption from frequency, including donation day, students and students; e) the distinctive badge of "Honorary Donor" at the first donation and "Diploma of Honor" for at least five donations of blood; f) appointment with priority for ambulatory care at specialized offices, medicines and free sanitary materials-in hospitalization and outpatient conditions-in public health facilities, for donors presenting conditions resulting from blood donation; g) priority in obtaining treatment tickets in the Ministry of Health units and reducing by 50% the cost of these tickets for people with at least 15 donations in the last 5 years; h) subscription with 50% discount for public transport, in the locality of residence, for a period of 2 months; settlement of transport expenses between the locality of residence and the locality where the donation of blood is made, on the occasion of each donari. (2) The level of allowances and rewards provided for in this Law shall be determined by Government Decision. (3) Plasmapheresis plasma donors are entitled to the same reward as blood donors, after five donations, regardless of the time intervals between two donations, but no more than three rewards within a 12-month period. (4) Donors who donate blood or blood cells to obtain reagents intended for diagnosis may receive a reward for this type of donation, based on a convention established only with the institutions specialized in transfusion within the the network of the Ministry of Health or the Ministry of National Defence, after the donor has previously taken knowledge, under signature, about the purposes and risks of this donation and had a term of thinking of 7 days. The reward may not be higher than the amount of vouchers equivalent to four blood donations. (5) The rights of the military honorary donors shall be established on the basis of the provisions of this law, by application to the specifics of the activities of the armed forces, and shall be approved by order of the ministers who have military personnel in subordination. (6) The rights of donors will be granted on the basis of evidence released for this purpose by blood transfusion centers. ((7) The expenditure on honorary donors of blood shall be borne by local budgets. + Article 11 (1) The salary for days off from work is equivalent to the average daily wage, calculated according to the legal provisions. (2) For blood donors, members of cooperative organizations and associations, the salary for days off is equivalent to the rate of the day worked. (3) Legal and physical persons who use salaried personnel will benefit from tax exemption, under the law, for the amounts representing the value of days off granted to employees for the donation of blood or plasma. + Article 12 The declaration by donors of communicable diseases, as well as of the risk factors known by them, after a prior information in the medical examination, is mandatory. + Chapter 3 Therapeutic use of human blood + Article 13 The scientific rules on transfusion therapy are established by regulation developed by the Ministry of Health. + Article 14 In each hospital a medical commission of hemovigilance is organized, which supervises and analyzes the transfusion security measures taken for the protection of the recipient patient, as well as the consumption of transfusion blood or blood derivatives. + Article 15 (1) Medical haemovigilance commissions in each hospital will encourage the practice of autotransfusion in surgical patients who do not have medical contraindications for this technique. (2) The Ministry of Health shall establish, by regulation, the rules for the practice of self-transfusion. ((3) Patients undergoing self-transfusion procedure do not consider themselves as blood donors, and their single cannot be used in other patients. + Article 16 (1) The administration of the blood and its derivatives for patients admitted to hospitals is made by the Transfusion Point or through the transfusion sections, by the medical-health personnel specialized in transfusion. (2) The transfusion point is led by a specialist doctor subordinated to the head of the anesthesia and intensive care department. (3) The legal medical liability for the activity of the Transfusion Point and of the personnel executing or controlling the transfusion activity is established by the regulation of operation of the transfusion units, elaborated by the Ministry Health. + Article 17 (1) The therapeutic administration of blood-lable preparations is considered emergency therapy and is carried out free of charge for the sick by healthcare facilities. (2) The concentrated cellular mass of erythrocytes, platelets or leukocytes, frozen or liquid plasma and the concentration of anti-hemophilic factor VIII shall be considered. + Article 18 (1) Stable preparations of serum or human plasma, either with therapeutic use or with diagnostic use, which have stability in conservation for a duration exceeding 2 months, are industrial pharmaceuticals, which have a medicine. ((2) Stable plasma products intended for haemophilia treatment, in all forms, are free of charge only for haemophiliac patients. + Chapter 4 Transfusion organisation + Article 19 (1) The basic health units for the transfusion organization are: the county blood transfusion center and the city of Bucharest, public institutions with legal personality in the structure of which the blood transfusion centers can operate city and municipal. (2) In justified cases, blood transfusion sections may be organized in the structure of hospitals, for their own needs, which are medically coordinated by the blood transfusion centers. + Article 20 The county blood transfusion centers, as well as the Blood Transfusion Center of Bucharest municipality execute harvesting actions at the headquarters, at the fixed harvesting points located in polyclinics or in dispensaries or at the workplace of donors, through mobile teams. + Article 21 The technical functioning regulation of blood transfusion centers is approved by the Ministry of Health, based on the proposal of the National Institute of Transfusion Hematology and the National Transfusion Commission. + Article 22 Blood transfusion centers deliver blood products to transfusion points in hospitals and technically control their transfusion activity. + Article 23 The county blood transfusion centers and the city of Bucharest are led by a director doctor. They are controlled, from a financial, epidemiological point of view and the performance of specific functions of harvesting, delivery and administration of blood, by the Ministry of Health and its specialized bodies. + Article 24 (1) Each blood transfusion center is part of a regional blood transfusion group, coordinated, from a technical point of view, by the director of the regional blood transfusion center, located in a city that is, as a rule, medical university center. (2) The number of regional blood transfusion groups and the arondate county blood transfusion centers shall be fixed by the Ministry of Health. + Article 25 (1) The specialized bodies of the Ministry of Health on the control of transfusion activity are: a) the National Hemovigilance and Ethics Commission; b) National Reference Laboratory; c) National Institute of Transfusion Hematology; d) National Transfusion Commission. (2) The organization, duties and functioning of these bodies shall be established by regulations approved by order of the Minister of Health. + Article 26 The control of the prophylaxis of transmissible viral infections is carried out through the National Reference Laboratory, for viruses communicable by blood, subordinated to the Ministry of Health, as well as through the network of inspectorates of health police and medicine preventive. + Article 27 The Ministry of National Defence has a transfusion network organized on the basis of regulations adapted to the technical norms established for the Ministry of Health's own transfusion network. + Article 28 (1) The activity of scientific and didactic research in transfusion hematology is carried out through the National Institute of Transfusion Hematology in Bucharest and through the regional transfusion centers, in collaboration with hematology clinics, immunology, oncology and medical-surgical for transplantation. (2) Scientific research in transfusion is oriented after the national interest issue established by the National Institute of Transfusion Hematology and the National Transfusion Commission, in collaboration with the Academy of Medical Sciences and other medical institutions. + Article 29 ((1) Single, blood and plasma derivatives can only be used by medical prescription, following a medical examination of the patient and only for therapeutic or diagnostic purposes. ((2) Restringation of the clinical indications of blood and derivatives transfusion only for cases with indications shall be under the responsibility of the physician who cares for the patient. + Article 30 (1) The therapeutic and diagnostic products derived from single or plasma donated will be issued to healthcare facilities by blood transfusion centers and other authorized specialized units. (2) The therapeutic and diagnostic products derived from blood or plasma may also be released directly to the population, on a prescription basis, in accordance with the legal provisions. + Chapter 5 Sanctions + Article 31 Violation of the provisions of this law attracts disciplinary, material, civil, contravention or criminal liability, as appropriate. + Article 32 It constitutes contraventions, if not committed under such conditions as to constitute crimes, committing the following facts: a) performing activities related to the donation, harvesting, processing and use of human blood, without authorization from the Ministry of Health or under conditions other than those provided for in the legal authorization; b) the modification or the attempt to modify the biological characteristics of a person's blood, before the harvest, without its consent; c) disclosure of information that allows the simultaneous identification of the donor and the recipient; d) the disposal of blood or derived products at a rate different from that established legally. + Article 33 (1) Contraventions provided in art. 32 lit. a) and d) are sanctioned with contravention fine from 300,000 lei to 2,000,000 lei. (2) Contraventions provided in art. 32 lit. b) and c) are sanctioned with a fine of 200,000 lei to 1,000,000 lei. (3) The contravention fines may also be applied to legal entities, in which case the minimum and maximum limits shall be doubled. + Article 34 The finding of contraventions and, where appropriate, the application of sanctions shall be made by persons specially empowered by the Ministry of Health. + Article 35 The provisions of this Law shall be supplemented by the provisions of 32/1968 on the establishment and sanctioning of contraventions, amended, except art. 25-27. + Article 36 The following facts are offences: a) the intentional non-declaration, by the donor, of communicable diseases and known risk factors, at prior information in the medical examination; b) the action to determine a person to donate blood in exchange for money rights, for the purpose of marketing the donated blood or its derivatives; c) the action to determine a person, by physical or moral coercion, to donate blood; d) the distribution of a blood product that does not appear on the list of products authorized by the e) harvesting or trying to harvest blood from a person without its consent; f) harvesting or trying to harvest blood from a minor or from a major person without discernment, outside the specific medical indications; g) the organization of transfusion for the purpose of obtaining profit realized on account of blood, plasma and blood derivatives of human origin; h) use with intent or distribution of blood products, without being proceeded to regulatory biological analyses for the detection of communicable diseases by blood; i) disclosure of data related to blood deposits and its derivatives, of strategic national interest. + Article 37 (1) The offences referred to in art. 36 lit. a), b), c) and d) shall be punished with imprisonment from 6 months to 3 years or with a fine. (2) The offences referred to in art. 36 lit. e), f), g), h) and i) shall be punished with imprisonment from 6 months to 5 years. + Chapter 6 Transitional and final provisions + Article 38 (1) The Red Cross Society of Romania, as well as the associations of honorary donors of blood support the health facilities in the activity of donor recruitment and stimulation of blood donation. ((2) Other professional, social, religious or natural or legal organizations may support this activity. (3) The ministries, the other central and local bodies of the public administration, the county health departments and the city of Bucharest, as well as the cultural, broadcasting and television institutions are obliged to support the propaganda actions organized for the purpose of donating blood, according to the skills they have. (4) Local councils are required to facilitate all actions to promote donation and collection of blood, by making available blood transfusion centres suitable for mobile collection and information media teams. of population. + Article 39 (1) The expenses for carrying out actions aimed at contributing to the education of citizens for the purpose of blood donation and on the way of harvesting the blood and voluntary participation in this humanitarian action will be made from the amounts provided annually in the budget of the Ministry of Health, for health (2) For the purpose provided in par. (1), radio and television advertisements in connection with the donation of blood are free of charge. + Article 40 (1) Until the conditions of operation of a Romanian industrial unit for plasma fractionation are created, the therapeutic products derived from plasma will be carried out as follows: a) through cooperation with a modern industrial unit abroad, under the law; b) by plasma processing in the transfusion network of the Ministry of Health, within the quantitative and qualitative limits imposed by the existing technical equipment, which will be modernized. ((2) The participation with serum or plasma in the production of derived, therapeutic or diagnostic preparations is part of the obligations of the blood transfusion centers and of the other authorized units, under the regulatory contractual conditions approved by Health Ministry. + Article 41 (1) This law shall enter into force within 30 days of its publication in the Official Gazette of Romania. (2) On the same date, the provisions of Government Decision no. 999/1990 , published in the Official Gazette of Romania, Part I, no. 106 of September 15, 1990, amended by Government Decision no. 132/1992, published in the Official Gazette of Romania, Part I, no. 55 of April 1, 1992 and by Government Decision no. 73/1993, published in the Official Gazette of Romania, Part I, no. 52 of March 8, 1993, and republished in the Official Gazette of Romania, Part I, no. 53 53 of 9 March 1993, and any other provisions to the contrary. (3) Within 30 days from the publication in the Official Gazette of Romania of this Law, the Ministry of Health shall submit to the Government the draft decision on the establishment of the National Institute of Transfusion Hematology and other provisions contained in the law, which is regulated by Government decision. This law was adopted by the Senate at the meeting of December 29, 1994, in compliance with the provisions of art 74 74 para. (1) of the Romanian Constitution. SENATE PRESIDENT prof. univ. dr. OLIVIU GHERMAN This law was adopted by the Chamber of Deputies at the meeting of December 29, 1994, in compliance with the provisions of 74 74 para. (1) of the Romanian Constitution. CHAMBER OF DEPUTIES PRESIDENT ADRIAN NASTASE -----------------------