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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LAW No. 4 of 10 January 1995 on blood donation, the therapeutic use of human blood transfusion organization in Romania'S PARLIAMENT ISSUING published in MONITORUL OFICIAL NR. 9 out of 19 January 1995, the Romanian Parliament adopts this law.

Chapter 1 General provisions Article 1 (1) donating blood for therapeutic purposes, in order to contribute to the protection of public health, is a humanitarian gesture, voluntary, anonymous and bearing.

(2) blood donation is made only by persons who have the age between 18 and 65 years and, following medical examination, do not present themselves for medical contraindications or risk factors for diseases transmissible via any kind of blood.

(3) sampling blood from minor or adult lacking discernment, unless a medical indications, is prohibited.

Article 2 Persons donor blood for therapeutic purposes are declared honorary blood donors.

Article 3 (1) transfusion Activity based on profit, what would achieve on account of blood, plasma and blood derivatives of human origin, is prohibited.

(2) Collection of blood as a result of physical constraints or morals of a person is prohibited.

Chapter 2 article 4 Blood Donation activity of transfusion from Romania is organized and controlled by the Ministry of health through its specialized units.

Article 5 of the harvest, preservation and distribution of human blood and blood products, the Ministry of health has the following obligations: a) organizes, directs and controls the work of harvesting, preparation and preservation of human blood and its derivatives, carried out through its specialized units authorized;

b) lays down requirements concerning the annual forecast singe on the basis of proposals made by the territorial health departments through blood transfusion centres;

(c) ensure, through units) and other sanitary epidemiological control units and blood donor clinic, laboratory control of blood collected, as instructed by the Ministry of health, in order to ensure its quality;

d) directs and controls the use in therapy and diagnosis of blood and its derivatives, focusing on the application of the most appropriate measures to prevent the transmission of posttransfuzionale reactions and any infections;

e) organise the work of establishing the blood group of citizens, with a view to its inclusion in the law, in the identity card;

f) ensure human blood reserve and its derivatives for contingencies;

g) organise the involvement of physicians and health personnel in actions relating to attracting new Honorary blood donors;

h) reutileaza and equips the blood transfusion centers with modern equipment-specific activity, including computer science, in order to operate at optimum parameters.

Article 6 (1) harvesting human blood or plasma for therapeutic purposes may be carried out at Headquarters or by mobile teams, only by the specialised sanitary units for this activity, on the basis of permits issued by the Ministry of health operation and, respectively, the Ministry of national defence, for its subordinate units flying.

(2) the separation, processing and preservation of blood or plasma, and derivatives of blood or plasma are carried out by specialised institutions, authorised by the Ministry of health.

(3) the conditions Plasmapheresis technical shall be determined by the Ministry of health, through the regulation drafted for this purpose.

Article 7 (1) harvesting and preserving blood and plasma are carried out according to the instructions of the Ministry of health.

(2) collection of blood and plasma will be done only under medical supervision and responsibility.

(3) Frequency donarilor and quantities taken from each donation shall be established by regulations of the Ministry of health. The taking of blood from a donation will be 5-7 ml/kg body weight of the donor, but not greater than 450 ml.

Article 8 (1) Placing or removing from the land of human blood and blood products or of the plasma can only be made on the basis of the authorization of the Ministry of health, for each lot, without prejudice to national reserve stocks.

(2) institutions in the field of the Ministry of national defence, authorized by the Ministry of health will inform the Organization and carrying out of such activities imposed by the necessity of solving some specific aspects of the activity chain of this Ministry.

Article 9 in order to obtain blood-derived products with specific therapeutic action or diagnose, immunization of donors with foreign antigens is subject to the instructions of the Ministry of health. Immunization cannot be made with the written consent of the postulates of the donor, after he took the knowledge about her goals and risks.

Article 10 (1) Honorary Blood Donors, and donors of plasma by plasmapheresis shall be entitled, upon request, for each donation, the following: a) a table at Center of blood transfusion or a combination of a meal at a restaurant or vouchers for food, at the level of the allowance;

b) every fifth donation, a reward in the form of vouchers for food, provided those donari to be undertaken in 2 consecutive years and within the limits of the frequency and the amounts collected in accordance with the provisions of this law;

c) 2 days off from work, including the day of donation, for employees employed in public institutions, as well as to other legal persons;

d) 2 consecutive days of relief, including donation day, pupils and students;

the distinguishing badge of e) "Donor" to the first donation and "Diploma of honour" for at least five donari blood;

f) priority programming for outpatient care at specialist clinics, medicines and sanitary materials for free-conditions of hospitalization and outpatient public health units-in, for donors showing diseases resulting from blood donation;

g) priority in obtaining tickets for the Ministry of health treatment and reducing by 50% the cost of these tickets for people with at least 15 donari in last 5 years;

h) subscription with 50% reduction for public transport, the place of residence, for a period of 2 months; reimbursement of transport between the place of residence and the place where blood donation is made, on the occasion of each donari.

(2) the amount of the allocations and rewards provided for in this law shall be determined by decision of the Government.

(3) donors of plasma by plasmapheresis are entitled to the same reward as blood donors after five donari, regardless of time intervals between two donari, but no more than three rewards within a period of 12 months.

(4) donors who donate blood or blood cells for reagents intended for diagnosis can receive a reward for this type of donation, based on an agreement established with institutions specialized only in establishments within the network of Ministry of health or the Ministry of national defense, after the donor has taken beforehand knowledge, under signature, about the goals and risks donari and had a long tradition within 7 days. The reward may not be greater than the amount of money equivalent to four bonds donari bloodbath.

(5) the rights of the military honorary blood donors shall be determined on the basis of the provisions of this law, by application to the specific activities of the armed forces, and is approved by order of the Ministers who subordinated military personnel.

(6) the rights of donors will be awarded on the basis of evidence issued for the purpose of blood transfusion centres.

(7) expenses relating to honorary blood donors it supports from local budgets.

Article 11 (1) 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 organizations and cooperative associations, the salary for the holidays is equivalent to the rate of the day.

(3) legal and physical Persons that use personal employee will qualify for tax exemption under the law, for the amounts which represent the counterpart of holidays granted to employees for the donation of blood or plasma.

Article 12 the Declaration by donors for communicable diseases, as well as the known risk factors, after a previous information within the medical examination is mandatory.

Chapter 3 human therapeutic use of blood Article 13 detailed rules regarding transfusion therapy scientific are set by regulation, drafted by the Ministry of health.

Article 14 each hospital is a medical Commission of hemovigilenta, who oversees and analyses the security measures taken to protect the patient's transfusion recipient, and the consumption of blood or blood derivatives transfuzional.

Article 15 (1) hemovigilenta medical Committees in each hospital will encourage the practice of autotransfuziei chirurgicali in patients without medical contraindications for this technique.

(2) the Minister of health determines, by regulation, the rules of practice of the autotransfuziei.

(3) Patients undergoing the procedure autotransfuzie is not considered blood donors, and their single may not be used for other patients.

Article 16 (1) the administration of blood and its derivatives for hospitalized patients in hospitals is done through blood transfusion or by departments, medical staff specialized in health establishments.

(2) establishment is run by a specialist subordinate head of anaesthesia and intensive care.

(3) liability for legal medical activity of transfusion and personnel who perform or supervise the work shall be determined by the rules of transfusion of blood units operating, prepared by the Ministry of health.

Article 17 (1) therapeutic Administration of labile blood is considered an emergency therapy and are carried out free of charge for the sick of the health care units.

(2) considering the mass concentrated preparations of labile cell erythrocytes, leukocytes, platelets or plasma frozen or liquid and concentrate factor VIII antihemofilic.

Article 18 (1) stable serum or Preparations from human plasma or therapeutic use or use diagnostics, which are stability in preservation for a period exceeding two months are industrial products, pharmaceutical products, which are in medicine.

(2) products intended for the treatment of hemophilia plasma stable under all forms are free only for hemophiliac patients.

Chapter 4 organisation of transfusion in article 19 (1) of the basic health Units for transfusion are: Organization of blood transfusion centre County and the municipality of Bucharest, public institution with legal personality which may function in structure of blood transfusion centres and municipal towns.

(2) in duly justified cases you can organize sections of blood transfusion in hospitals for their own needs, which in terms of medical are coordinated by the blood transfusion centers.

Article 20 of blood transfusion centres in the County, as well as blood transfusion centre of the municipality of Bucharest harvesting actions run at Headquarters, at fixed points of harvesting can be found in clinics or in health centres or at the workplace of the donors, through mobile teams.

Article 21 of the rules of procedure of blood transfusion centres shall be approved by the Ministry of health, on the basis of a proposal from the National Institute of Hematology and Transfusion of blood of the National Commission.

Article 22 blood transfusion centres deliver blood products from blood transfusions in hospitals and controls from a technical standpoint their transfusion.

Article 23 blood transfusion centres and of the municipality of Bucharest are led by a physician directory. They are controlled, from a financial standpoint, and the completion of the epidemiological specific functions of collection, delivery and administration of blood, by the Ministry of health and its specialized bodies.

Article 24 (1) Each blood transfusion centre is part of a regional grouping of blood transfusion, coordinated, from the technical point of view, the physician director of blood transfusion centre, set in a city that is, as a rule, University medical center.

(2) the number of regional groupings of blood transfusion and blood transfusion centres, subordinated the County shall be fixed by the Ministry of health.

Article 25 (1) of the Ministry of health concerning the control of transfusion are: a) national Hemovigilenta Commission and ethics;

(b) the National Reference Laboratory);

c) National Institute of Transfusion Haematology;

d) national Transfusion Commission.

(2) the Organization, powers and functioning of such bodies shall be determined by regulations approved by order of the Minister of health.

Article 26 Control communicable viral infections prophylaxis is carried out by the national reference Laboratory for virus infection transmissible through blood, subordinated to the Ministry of health, and through the network of regional directorates of health and preventive medicine.

Article 27 National Defense Ministry has organized a transfusion network on the basis of regulations adapted to the technical standards established for the network of establishments of the Ministry of health.

Article 28 (1) scientific research and teaching in hematology transfusion is carried out by the National Institute of Hematology and Transfusion in Bucharest through regional centres of transfusion, in collaboration with the clinics of Hematology, immunology, Oncology, and medical-surgical transplantation.

(2) scientific research in transfusion targets after the issue of the national interest to be determined by the National Institute of Transfusion Hematology and transfusion, the National Commission in collaboration with the Academy of medical sciences and other medical institutions.

Article 29 (1) Single, blood and plasma derivatives may not be used than by medical prescription, following a medical examination of the patient and only for therapeutic or diagnostic purposes.

(2) provide for the clinical indications for transfusion of blood and derived only for cases with indication is made under the responsibility of the doctor who takes care of the patient.

Article 30 (1) therapeutic and diagnostic use derived from single or in plasma donated will be issued units of medical care by the blood transfusion centers and other specialized units.

(2) Therapeutic Products and diagnostic use derived from blood or plasma may be issued directly to population-based prescription in accordance with legal provisions.

Chapter 5 article 31 Penalties violation this law shall entail disciplinary, material, administrative, civil or criminal, as appropriate.

Article 32 Constitute offences, unless they have been perpetrated in such conditions to constitute the crime, committing the following acts: (a)) regarding activities the donation, collection, processing and use of human blood, without authorization from the Ministry of health or under conditions other than those laid down in the legal authorization;

b) modification or attempt to amend the biological characteristics of a person's blood before the harvest, without consent;

c) disclosure of information identifying the donor and at the receiver;

d) disposal of blood or derivatives at a rate different from that set.

Article 33 (1) the Offences referred to in articles. 32 lit. ) and (d)) shall be sanctioned with contraventional fine from 2,000,000 to 300,000 lei lei.

(2) the Offences referred to in articles. 32 lit. b) and (c)) shall be imposed with a fine from 1,000,000 to 200,000 lei lei.

(3) administrative Fines may be imposed and to legal persons, in which case the minimum and maximum limits are doubled.

Article 34 the finding of violations and, where appropriate, sanctions are carried out by persons specially authorized by the Ministry of health.

Article 35 the provisions of this law shall be supplemented by the provisions of law No. 32/68 on the establishment and sanctioning offences, as amended, with the exception of art. 25-27. Article 36 Constitutes offences the following facts: a non-intentional), by donor, communicable diseases and known risk factors, information under the prior medical examination;

b) to determine an action person to donate blood in Exchange for pecuniary rights, for the purpose of marketing of blood donated or its derivatives;

c) to determine an action person, through physical or moral constringere, to donate blood;

d) distributing a blood product that is included in the list of products approved by the Ministry of health;

e) harvesting or trying to harvest blood from a person without the consent of the latter;

f) harvesting or attempt to harvest blood from a minor or major in a person lacking in discernment, unless specific medical indications;

g) organisation of transfusion in order to obtain profit achieved on account of blood, plasma and blood derivatives of human origin;

h) intentional use or distribution of blood products without being conducted biological tests for the detection of communicable diseases regulations through blood;

I) the disclosure relating to blood and deposits its derivatives, strategic national interest.

Article 37 (1) the crimes referred to in article 1. 36 lit. a), b), c) and (d)) shall be punished with imprisonment from six months to three years or by a fine.

(2) the Offences referred to in articles. 36 lit. e), f), (g)), h) and (i)) are punishable by imprisonment from 6 months to 5 years.

Chapter 6 transitional and final Provisions Article 38 (1) Red Cross Society from Romania, as well as honorary blood donor associations supports the health units in donor recruitment activity and stimulation of blood donation.

(2) other professional organizations, religious or social, physical or legal persons can not support this activity.

(3) the ministries, other Central and local bodies of public administration, county health departments and Bucharest, as well as cultural institutions, radio and television are obligated to support the actions of organized propaganda for the purpose of blood donation, according to the skills you have.

(4) the local councils have a duty to facilitate all actions for the promotion of blood donation and collection of, by putting at the disposal of blood transfusion centres, premises suitable for mobile collection teams and means of informing the general public.

Article 39 (1) expenditure for actions intended to contribute to the education of citizens in order to blood donation and the way blood collection and voluntary participation in this humanitarian action will be made of the amounts provided for in the annual budget of the Ministry of health, health education.

(2) for the purpose referred to in paragraph 1. (1) advertisements on radio and television in connection with the donation of blood is free of charge.

Article 40 (1) to create the conditions for the operation of industrial units for a Romanian fractionarea plasma, therapeutic plasma-derived products shall be made as follows: a) through cooperation with a modern industrial unit from abroad, according to the law;

b) processing plasma transfusion network of the Ministry of health, the quantitative and qualitative limits imposed by technical equipment, which will be modernized.

(2) participation with serum or plasma derivative production preparations, therapeutic or diagnostic tools is part of the obligations of blood transfusion centres and other establishments approved under the terms of the contractual regulations approved by the Ministry of health.

Article 41 (1) this law shall enter into force 30 days after its publication in the Official Gazette of Romania.

(2) on the same date shall repeal the provisions of governmental decision nr. 999/90, not published in the Official Gazette of Romania, part I, no. 106 of 15 September 1990, as amended by Government decision No. 132/92, published in the Official Gazette of Romania, part I, no. 55 from 1 April 1992 and by the decision of the Government. 73/93, published in the Official Gazette of Romania, part I, no. 52 of 8 March 1993, and republished in the Official Gazette of Romania, part I, no. 53 of 9 March 1993, as well as any other provisions to the contrary.

(3) within 30 days of its publication in the Official Gazette of the present law, the Ministry of health will submit the draft Government decision on the establishment of the National Institute of Transfusion Haematology and other provisions contained in the law, which shall be regulated by the Government.

This law was adopted by the Senate at its meeting on December 29, 1994, in compliance with the provisions of art. 74 para. (1) of the Constitution of Romania.
SENATE PRESIDENT Prof. Dr. O'LEARY GAITAN this law was adopted by the Chamber of deputies at its meeting on December 29, 1994, in compliance with the provisions of art. 74 para. (1) of the Constitution of Romania.
PRESIDENT Of The CHAMBER Of DEPUTIES ADRIAN NASTASE — — — — — — — — — — — — — — — — — — — — — — —

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