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Law No. 460 Of 12 November 2003

Original Language Title:  LEGE nr. 460 din 12 noiembrie 2003

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LEGE no. 460 460 of 12 November 2003 (* updated *) on the exercise of the professions of biochemist, biologist and chemist, the establishment, organization and functioning of the Order of Biochemists, Biologists and Chemists in the Romanian healthcare system ((updated until 21 April 2016 *)
ISSUER PARLIAMENT




---------- The Romanian Parliament adopts this law + Chapter I The exercise of the professions of biochemist, biologist and chemist in the healthcare system in Romania + Section 1 General provisions + Article 1 ((1) The exercise of the professions of biochemist, biologist and chemist in the health system in Romania is a right of any natural person, Romanian citizen or citizen of a Member State of the European Union, holder of the diploma issued by an institution of higher education of biochemical, biological or chemical profile, recognized by law, and having the necessary competence for carrying out laboratory analyses. (2) In the laboratory biochemist, biologist and chemist have the right to initiative and decision in terms of laboratory techniques and apparatus for the maximum operativeness and liability execution of the requested analyses, under signature. (3) The exercise of the professions of biochemist, biologist and chemist in the health system is authorized by the Ministry of Health. + Article 2 The professions of biochemist, biologist and chemist in the health system include rights and responsibilities resulting from the job description. + Article 3 (1) The exercise of the professions of biochemist, biologist and chemist in the health system is based on the authorization of free practice, which is granted by the Ministry of Health on the basis of the following acts: a) diploma issued by a higher education institution of biochemical, biological or chemical profile, recognized by law; b) certificate of criminal record; c) health certificate; d) opinion of the Order of Biochemists, Biologists and Chemists. (2) The exercise of the professions of biochemist, biologist and chemist in some laboratories in the health system is also done on the basis of the accreditation certificate, which is granted by the Ministry of Health on the basis of the following acts: a) authorization of free practice; b) employee certificate; c) cerere-tip; d) opinion of the Order of Biochemists, Biologists and Chemists. + Article 4 (1) The professions of biochemist, biologist and chemist can be practiced in public or private health facilities and in educational and research institutions with biomedical profile. (2) In public hospitals and outpatients biochemists, biologists and chemists at least 5 years old in the specialty can serve as head of laboratory. + Article 5 The biochemist, biologist and chemist, employed in public or private health facilities, have rights and obligations arising from legal norms and regulations, from the provisions of the individual employment contract and from the internal order regulations. + Article 6 Biochemists, biologists and health care chemists, who have the title of doctor of science and who meet the conditions of standard retirement age, can continue professional activity, on request, until the age of 65, women, and for 70 years, men, through annual extensions, under the conditions provided in art. 3 3 para. ((1), only with the agreement of the employer. *) + Article 7 The professions of biochemist, biologist and chemist can be practiced in free practice practices for public services related to the medical act. Their income can also be made from services provided under the contract with health care providers or health insurance companies. + Article 8 Ensuring the protection of the biochemist, biologist and chemist in the health system, for the risks arising from professional practice, is the employer's obligation and is carried out by the employer through the insurance companies. + Article 9 The content and characteristics of the biochemist, biologist and chemist's activity are: a) carry out laboratory investigations according to the training and specialization; b) participate in control programs on the health status of the population; c) participate in the theoretical and practical training of future specialists who have included laboratory practice in the training programs; d) participate, together with doctors and other staff, in medical research; e) participate, together with other staff, to protect the environment. + Section 2 Training, improvement and specialization of biochemists, biologists and chemists in the Romanian healthcare system + Article 10 The formation of biochemists, biologists and chemists in the health system is carried out in higher education institutions recognized by the law, based on the programs developed by the Ministry of Education, Research and Youth. + Article 11 The biochemist, biologist and chemist in the health system have the professional obligation to prepare through continuous training programs, developed by the Ministry of Health in consultation with the Order of Biochemists, Biologists and Chemists. + Article 12 (1) The specialization of biochemist, biologist and chemist in the health system is carried out through programs having specific content and duration, according to the requirements, in institutions empowered for the proposed purpose. (2) The non-payment specialization is performed theoretically through courses and practice in medical laboratories. (3) The duration of the specialization is 4 years. (4) Specialization is completed with the obtaining of the specialized diploma, by taking an exam. (5) I take exception to the provisions of par. (2) and (3) accredited biochemists, biologists and chemists, who are at least 5 years old in the field of health or in educational and research institutions with biomedical profile, on the date of entry into force of this law. + Article 13 The methodology for conducting continuous professional training programs and awarding diplomas certifying the completion of the courses is established by the Ministry of Health and higher education institutions, in consultation with the College Doctors in Romania and the Order of Biochemists, Biologists and Chemists. + Article 14 The forms of training, specialization and professional improvement, carried out abroad by biochemists, biologists and chemists in the health system, are assimilated to those equivalent in the country, according to the regulations in force. + Section 3 Rules of ethics and professional deontology + Article 15 In the exercise of the profession, the biochemist, biologist and chemist in the health system respect the dignity of the human being and the principles of ethics, showing professional and moral responsibility, always acting in the interest of the patient, the patient's family and community. + Article 16 The biochemist, biologist and chemist in the health system are obliged to keep professional secrecy. + Article 17 Disputes or deviations from professional ethics shall be considered and the measures shall be taken, as the case may be, by the head of the medical team or by the management of the unit or by the Romanian College of Physicians, together with the Order of Biochemists, Biologists and Chemists, according to the Code of Ethics and Professional Deontology of Biochemists, Biologists and Chemists in the Health System. + Section 4 Relations that are established in the exercise of the profession of biochemist, biologist and chemist in the health system + Article 18 The activity of the biochemist, biologist and chemist in the health system is carried out individually or within mixed collective. + Article 19 The biochemist, biologist and chemist in the healthcare system collaborate with the doctor and recognize his coordinating role, as well as with the other members of the collective, participating in the maintenance of amicable relations within it and contributing to quality assurance of the medical act + Article 20 The members of the Order of Biochemists, Biologists and Chemists in the Romanian health system are obliged to apply the paraphernalia including the name, surname, degree and specialty on all the bulletins for the analyses they carry out. + Article 21 Relations between biochemists, biologists and chemists in the healthcare system are based on fairness, collaboration, mutual respect and professional solidarity, according to the Code of Ethics and Professional Deontology of Biochemists, Biologists and Health care chemists. + Chapter II Establishment, organization and functioning of the Order of Biochemists, Biologists and Chemists in the Romanian Health System + Section 1 General characteristics + Article 22 (1) The Order of Biochemists, Biologists and Chemists in the Romanian Health System is established as a professional, non-governmental, apolitical, non-profit and legal entity, representing the interests of its members. (2) The Order of Biochemists, Biologists and Chemists in the Romanian Health System includes biochemists, biologists and chemists authorized to exercise their profession in units of the Ministry of Health or other ministries with their own health network, in the private health sector and in biomedical research units. + Article 23 The Order of Biochemists, Biologists and Chemists in the Romanian Health System is headquartered in Bucharest. + Section 2 Tasks of the Order of Biochemists, Biologists and Chemists in the Romanian Health System + Article 24 The Order of Biochemists, Biologists and Chemists has the following tasks: a) defend the prestige and professional dignity of its members in relations with third-party natural or legal persons; b) defend and promote the professional interests of its members; c) issue internal rules, in compliance with the legal provisions; d) elaborates and supervises compliance with the Code of ethics and professional deontology of biochemists, biologists and chemists in the health system, adopted after its endorsement by the Ministry of Health; e) represent its members in relations with governmental, non-governmental organizations and trade unions, internally and internationally; f) provide professional assistance to its members in situations of judging cases of deviations from the norms of ethics and professional deontology, as well as dispute resolution; g) collaborates with the Ministry of Health for the elaboration of regulations regarding the registration in the single register of biochemists, biologists and chemists in the health system; h) collaborates with the Ministry of Health and the Romanian College of Physicians in the elaboration and monitoring of training programs, specialization and improvement of the theoretical and practical professional training of biochemists, biologists and chemists of the health system; i) collaborate with the Ministry of Health in order to develop specific norms and regulations on the profession of biochemist, biologist and chemist in the health system; j) endorses the issuance of the authorization of free practice for biochemists, biologists and chemists in the health system; k) act together with central and territorial health institutions for ensuring, in public and private health facilities, the quality of the medical act; l) endorse, together with the Romanian College of Physicians, the authorization for the installation of private medical laboratories and is pronounced in connection with the steps taken to prohibit their installation, taking into account the exercise work in accordance with the professional competence of the staff, the technical equipment and compliance with the environmental protection rules. + Section 3 Members of the Order of Biochemists, Biologists and Chemists + Article 25 (1) Members of the Order of Biochemists, Biologists and Chemists shall be entered in a single register, which shall be published periodically. (2) Members who are at the age of retirement remain enrolled, on request, in the Order of Biochemists, Biologists and Chemists. + Article 26 Members of the Order of Biochemists, Biologists and Chemists are obliged: a) comply with the legal regulations on the exercise of the profession of biochemist, biologist and chemist in the health system; b) to respect the status of the Order of Biochemists, Biologists and Chemists on the exercise of these professions; c) to respect and apply the rules of ethics and professional deontology. + Article 27 The incomes of the Order of Biochemists, Biologists and Chemists are constituted from: a) the registration fee and the monthly contributions of the members; b) donations, sponsorships, according to the law; c) funds resulting from scientific and editorial rights; d) other sources, in compliance with the legal provisions. + Article 28 Money funds can be used for administration expenses, such as: staff salaries, purchase of fixed funds, household material, financing of organizational expenses, improvement of professional training, granting of scholarships through the competition, the creation of institutions with philanthropic and scientific purpose and others, which are established by the National Council of the Order of Biochemists, Biologists and Chemists. + Section 4 Organization and functioning of the Order of Biochemists, Biologists and Chemists in the Romanian Health System + Article 29 The order of Biochemists, Biologists and Chemists in the Romanian health system is organized at national, county, and Bucharest. + Article 30 The governing bodies of the Order of Biochemists, Biologists and Chemists, at national and county level, respectively of the city of Bucharest, are: general assembly, national council, county council, respectively of Bucharest, and their executive offices. + Article 31 The elections for the governing bodies of the Order of Biochemists, Biologists and Chemists in the Romanian health system, at national and county level, respectively of the city of Bucharest, take place every 4 years. + Article 32 (1) The General Assembly of the Order of Biochemists, Biologists and Chemists, made up of representatives elected at the county level, respectively of the city of Bucharest, meets annually. (2) The General Assembly shall elect by secret ballot, by simple majority, the members of the National Council of the Order of Biochemists, Biologists and Chemists, in the presence of at least two thirds of the total number of elected representatives. (3) The General Assembly shall adopt, in the presence of at least two thirds of the total number of elected representatives, the Code of Professional Ethics and Deontology, the Statute and the Regulation for the Organization and Functioning of the Order of Biochemists, Biologists and Chemists. + Article 33 (1) The National Council of the Order of Biochemists, Biologists and Chemists is composed of 55 members, as follows: one representative of each county, 6 representatives of the city of Bucharest, 8 representatives of medical laboratories private in Romania, chosen by the general assembly of the Order of Biochemists, Biologists and Chemists. (2) The national council referred to in par. ((1) is legally constituted in the presence of half of its members and decides by simple majority. (3) The national council referred to in par. (1) meets in annual, ordinary and extraordinary sessions. (4) Within the national council provided in par. (1) specialist committees operate. + Article 34 Between the sessions of the national council provided in 33, the Order of Biochemists, Biologists and Chemists in the Romanian health system is coordinated by the executive office. + Article 35 (1) The executive office of the Order of Biochemists, Biologists and Chemists in the Romanian health system ensures its permanent activity, according to the law and its own regulations. (2) The Executive Office shall be composed of: Chairperson, 3 Vice-Presidents, one Secretary and 2 members, elected by secret ballot by the members of the national council provided for in 33. (3) The functions of the President, Vice-President and Secretary are incompatible with the corresponding functions of a trade union + Article 36 (1) The county council of the Order of Biochemists, Biologists and Chemists has a number of members in proportion to the number of biochemists, biologists and chemists of the registered health system, as follows: a) up to 50 members registered in the single register and contributions-up to 7 members; b) more than 50 members registered in the single register and contributions-up to 11 members. (2) The council established at the level of Bucharest municipality consists of 11 members. (3) The election of the members of the county councils, respectively of the city of Bucharest, ((1) and (2), shall be made by the general assembly, by secret ballot, by simple majority, by the participation of at least two-thirds of the total number of members entered in the single register and by contributions. The election of representatives for the General Assembly of the Order of Biochemists, Biologists and Chemists is made by secret ballot, by simple majority, according to the norm of representation, by a delegate to two members registered in the single register. Elections are validated in the presence of two-thirds of the total number of delegates. If two thirds of the total number of delegates are not present at the elections conference, another election conference will be held after two weeks, the result of which will be validated regardless of the number of participants. (4) The county council, respectively of the city of Bucharest, provided in par. (1) and (2), shall elect from among its members an office consisting of: president, 2 vice presidents and a secretary. (5) The functions of the President, Vice-President and Secretary are incompatible with the corresponding function in a trade union + Article 37 Persons who exercise leadership positions at national, county, and Bucharest, respectively, in the structures of the Order of Biochemists, Biologists and Chemists maintain their jobs during the period in which they perform the functions That. + Article 38 The governing bodies of the Order of Biochemists, Biologists and Chemists operate in accordance with the legal provisions and their own regulations. + Section 5-a Procedures and sanctions + Article 39 (1) Members of the Order of Biochemists, Biologists and Chemists who violate the specific regulations on the exercise of the professions of biochemist, biologist and chemist in the health system, as well as the Code of Ethics and Professional Deontology of biochemists, biologists and chemists in the healthcare system shall be subject to the following penalties: a) reprimand; b) warning; c) temporary suspension of the membership of the Order of Biochemists, Biologists and Chemists; d) the withdrawal of the membership of the Order of Biochemists, Biologists and Chemists and the proposal to the Ministry of Health to cancel the professional practice authorization for a period of 6 months to a year or definitively. (2) The application of sanctions provided in par. ((1) lit. a) and b) is the competence of the county councils of the Order of Biochemists, Biologists and Chemists, and the application of the para. ((1) lit. c) and d) is the competence of the national council. + Article 40 The conclusions of the investigation and sanctions applied are communicated in writing to the person concerned, to the county council, respectively of the city of Bucharest, of the Order of Biochemists, Biologists and Chemists, to the employer and, as the case may + Article 41 (1) Appeals against sanctions provided for in art. 39 39 para. ((1) lit. a) and b) can be made at the specialized commission of the National Council of the Order of Biochemists, Biologists and Chemists, within 30 days of the communication of the sanction. (2) Against the sanctions provided for in art. 39 39 para. ((1) lit. c) and d) can be challenged at the court in whose territorial area the biochemist, biologist and chemist in the health system who was sanctioned, within 30 days of the communication of the sanction, carries out his activity. + Article 42 Disciplinary responsibility of the members of the Order of Biochemists, Biologists and Chemists, provided in art. 39, does not exclude civil, patrimonial, contravention and criminal liability, as the case may be, according to legal provisions. + Article 43 The membership of the Order of Biochemists, Biologists and Chemists ceases as a result of the loss of the right to exercise these professions, as well as following non-payment, for 3 consecutive months, of the membership fee. + Article 44 The practice of the professions of biochemist, biologist and chemist in the health system by persons who do not have this quality constitutes a crime and is punishable according to the provisions of the Criminal Code. + Article 45 ((1) The organization of the elections for the establishment of the first governing bodies at national, county, and Bucharest, respectively, is carried out on the basis of the regulation developed by the central electoral commission of initiative, consisting of: a) a representative of the Ministry of Health b) a representative of the Romanian College of Physicians; c) 16 biochemists, biologists and chemists from the health system; d) a union representative. (2) The members of the national council and the county council, respectively of the city of Bucharest, of the Order of Biochemists, Biologists and Chemists shall be elected for a term of 4 years. + Chapter III Final provisions + Article 46 Biochemists, biologists and chemists in the health system are obliged to comply with the provisions of this law and the regulations specific to the sector in which they operate. + Article 47 The order of Biochemists, Biologists and Chemists in the Romanian health system works on the basis of this law and on the basis of its own adjustments, elaborated in accordance with the provisions of the law + Article 48 This law shall enter into force 30 days after its publication in the Official Gazette of Romania, Part I. This law was adopted by the Senate at the meeting of September 29, 2003, in compliance with the provisions of art 74 74 para. (1) of the Romanian Constitution.
SENATE PRESIDENT
NICOLAE VACAROIU
This law was adopted by the Chamber of Deputies at the meeting of October 21, 2003, in compliance with the provisions of 74 74 para. (1) of the Romanian Constitution.
p. CHAMBER OF DEPUTIES PRESIDENT,
VIOREL HREBENCIUC
Bucharest, November 12, 2003. No. 460. -----