MIDWIFERY ACT. (consolidated text, OG 120/08, 145/10) I. GENERAL PROVISIONS

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MIDWIFERY ACT (consolidated text, ) I. GENERAL PROVISIONS Article 1 This Act shall regulate the contents and the method of functioning, the standard of education, the conditions for carrying out the activities, duties, quality control and professional supervision of the work of midwives in the Republic of Croatia. The provisions of this Act regarding midwives shall apply appropriately also to persons with the following professions: midwife assistant, nurse-midwife, nurse in the midwife speciality, bachelor of midwifery, senior nurse in the gynecology-obstetrics speciality and master in midwifery. The terms used in this Act and in the regulations related to this Act with meaning related to gender, regardless of whether they are used in the male or female gender, shall include equally both the male and female gender. Article 2 Midwives shall be healthcare workers and their activity shall be an integral part of the healthcare in the interest of the Republic of Croatia, and it shall be carried out under the conditions and in the way prescribed in this Act. II. THE ACTIVITIES OF MIDWIVES Article 3 The activities of midwives shall include all processes, knowledge and skills of midwife care. When carrying out her duties, a midwife shall apply her best professional knowledge, by respecting the principles of the patients' rights, the ethical and professional principles in the function of protecting the health of the population and of each patient personally. Midwives shall be obliged to keep as a professional secret all the data on the health status of the patients. Article 4 Midwives shall carry out their activities on all levels of healthcare in accordance with the standards established in an ordinance by a minister competent for the healthcare system. Article 5 Midwife care shall be a public duty and subject to the control of meeting education standards. Article 6 Carrying out midwife care shall be based on the needs of the population in accordance with the plan and programme of healthcare measures. III. EDUCATION MIDWIFE EDUCATION STANDARD 1

Article 7 The basic education of midwife assistants shall be acquired by successfully completing the vocational education for the profession of midwife-assistant in accordance with with the valid regulations of the Republic of Croatia. The basic education of the bachelor in midwifery shall be acquired by successfully completing the undergraduate study for the profession of bachelor in midwifery in accordance with the valid regulations of the Republic of Croatia. Article 8 Midwives shall acquire the high level of education by successfully completing the appropriate undergraduate and graduate university study or the integrated undergraduate and graduate university study, in accordance with the regulations in the field of higher education. ADDITIONAL PROFESSIONAL TRAINING FOR MIDWIVES Article 9 Additional training for midwives shall be carried out if the scope and complexity of work and the expected results require additional education in a specific field of healthcare. Additional training shall be carried out in the purpose of improving the quality and effectiveness of midwife work. Article 10 An increased or altered complexity of works shall be established based on the contents and the type of procedures and skills expected from the midwife on specific levels of health care, and shall be related to the altered needs of the population and patients regarding midwife care, new scientific knowledge and therapeutic procedures. The need, contents and duration of the programme for additional training of midwives shall be determined by the Croatian Chamber of Midwives in a general act. Article 11 The additional training of midwives can be carried out in healthcare institutions, institutions for vocational education or at higher education institutions. CONTINUING PROFESSIONAL TRAINING Article 12 Midwives shall be obliged to continuously renew their acquired knowledge and acquire new knowledge pursuant with the latest achievements and knowledge in the field of midwifery. Continuous professional training is carried out by participating at professional seminars, courses and professional meetings. The contents, time periods and procedures of continuous professional training and proficiency evaluations of midwives shall be regulated by the Croatian Chamber of Midwives in a general act. IV. CONDITIONS FOR CARRYING OUT THE ACTIVITIES OF MIDWIVES Article 13 A midwife assistant who acquired the basic education for a midwife assistant in accordance with Article 7 paragraph 1 of this Act may carry out midwife care only under supervision. A midwife referred to in paragraph 1 of this Article shall carry out midwife care as a midwifeassistant. Monitoring the work of a midwife assistant may be carried out by a midwife with a valid approval for independent work referred to in Article 14 paragraph 1 of this Act, and a doctor, specialist in gynaecology and obstetrics. 2

Article 14 A leader of midwife care team shall be a midwife who has completed at least the undergraduate study, which is registered in the midwife register at the Croatian Chamber of Midwives (hereinafter: the Register) and who has an approval for independent work. Midwife care as part of a team (member of a healthcare team in primary health care, member of a team in hospital care) shall be carried out by a midwife registered in the Register and who has approval to carry out the independent work of a midwife assistant, midwife bachelor or master in midwifery. A midwife who acquired at least the basic education for midwives has the right to be registered in the Register in accordance with Article 7 paragraph 1 or Article 7 paragraph 2 of this Act, carried out the traineeship and passed the professional exam. The conditions of carrying out the traineeship and passing the professional exam referred to in paragraph 3 of this Article shall not refer to citizens of the Member States of the European Union. The provisions of the Act on Healthcare and of the implementation regulations adopted based on that Act shall apply to the contents, the duration of traineeship and the method of taking the professional exam for midwives. Article 15 A midwife who is registered in the Register and who has the approval for independent work referred to in Article 14 paragraph 1 of this Act shall have the right to independent work. The right to independent work within the competence determined by this Act shall be held by a midwife assistant, a bachelor in midwifery and a master in midwifery registered in the Register and with the approval for independent work referred to in Article 14 paragraph 2 of this Act. The approval for independent work of a midwife registered in the Register shall be provided, or withheld by the Croatian Chamber of Midwives in an administrative act as determined by the Statute. No complaint shall be allowed against the administrative act referred to in paragraph 3 of this Article, but an administrative dispute may be initiated. A midwife may carry out the activity of midwifery only within the limits of her education and the additional training as determined in the approval for independent work. The approval for independent work shall be extended every six years. The conditions for giving, renewing and withholding the approval for independent work of midwives shall be prescribed by the Croatian Chamber of Midwives in a general act. The provisions referred to in paragraphs 3 and 4 of this Article shall apply to the process of renewing and withholding the approval for independent work. THE WORK OF MIDWIVES Article 15a The work of a midwife assistant shall encompass the following: working within a healthcare team with supervision from a midwife and/or doctor, applying all acquired knowledge in the field of midwife care in accordance with the principles of professional ethics and the laws, participating in education in the purpose of preserving the health and preventing sexually transmitted diseases, discovering gynecologic diseases early and planning the family, and participating in carrying out the education in preparing for birth and parenthood, preparing pregnant women for examinations and additional examinations during pregnancy, preparing the area, instruments and materials for physiological birth, carrying out the procedures of preoperative preparation and postoperative care for the operational completion of birth, preparing patients for gynecologic, auxiliary and special examinations in gynaecology, 3

caring for the personal hygiene of pregnant women, child-bearing women and eclamptic women, carrying out the dressing and bathing of the newborn child, participating in the education of parents regarding the care for a healthy infant and breastfeeding, monitoring the nutrition of pregnant women, child-bearing women and eclamptic women, monitoring the general state during hospital accommodation/treatment of pregnant women, childbearing women and eclamptic women and of healthy newborns; recognizing the pathological changes of vital functions and informing the midwife and/or doctor of those, preparing the instruments and materials for sterilization, preparing the instruments and materials for examining the pregnant women and for birth, carrying the procedures of asepsis and the procedures for preventing hospital infections, carrying out the peroral and parenteral application of medication (except intravenous) requested by doctors. Article 15b The work of a midwife shall encompass the following: acting within a health team when a multidisciplinary approach is required; applying all acquired knowledge in the field of midwife care, in accordance with the principles of professional ethics and laws, and knowledge in the fields of obstetrics and gynaecology, keeping medical documentation on midwife care; planning, organising and carrying out midwife care; evaluating the plan of midwife care, analysis the conditions for carrying it out and carrying out the clinical realisation of planned midwife care, carrying out education in preparation for parenthood and birth and providing advice on breastfeeding, identifying pregnancy, guiding the physiological pregnancy and birth on all levels of health care, determining the potential pathological changes in pregnancy and birth of which the doctor must me informed; in case of emergency guiding rear-facing birth and carrying out the manual exploration and discharge of the womb, if necessary, carrying out episiotomies and stitching first and second degree perineum ruptures, as part of a health care team, participating in monitoring pathological pregnancies and births and participating during the operational completion of births, carrying out the procedures of preoperative preparation and postoperative care and the operational completion of births and carrying out intravenous therapy, carrying out monitoring of healthy newborns and informing a doctor of potential pathological states, monitoring the state of the mother after birth and differentiating the physiological and pathological course of the postpartum period, preparing and advising women on gynecologic examinations and carrying out education in the purpose of preserving the health and preventing sexually transmitted diseases, planning the family, and preserving the sexual and reproductive health, carrying out the peroral and parenteral application of medication requested by doctors V. DUTIES OF MIDWIVES Article 16 The duties of midwives include the following: applying all available knowledge in the field of midwifery, applying the methods for resolving issues in carrying out midwife duties which require the analytical 4

and critical approach, acting in accordance with the established rules and protocols for carrying out procedures in midwifery, carrying out midwife duties in accordance with the established plan, applying, implementing and keeping records of the doctor in local, peroral and parenteral therapy, reporting the doctor in due time in case of complications while applying therapy, implementing the procedures in the field of health care and preventing illnesses, keeping midwife documentation on all carried out procedures during 24 hours, informing the doctor in due time on the state of the patient, and especially on any changes of the health status, approaching the process of resuscitation if no doctor is present, holding professional secrets, respecting patient rights, respecting the midwife ethical codex, respecting the patients' religious principles, cooperating with all team members, maintaining the reputation of the institution (employer), using the tools and equipment in an economic and efficient manner acting in the interest of the patients. Article 17 The midwife shall record all carried out procedures on the midwife list for each individual patient on all levels of health care. The midwife list referred to in paragraph 1 of this Article shall be a list of data used for the quality control of the planned and implemented midwifery. The contents and form of the midwife list shall be prescribed by the minister competent for health care at the proposal of the Croatian Chamber of Midwives. MAJOR MISCONDUCT Article 18 The following shall be considered acts of major misconduct of a midwife: when due to negligence or ignorance a midwife causes damage to a patient, when a midwife changes the way and contents of therapy as requested by the doctor of practiced therapy and when a midwife intentionally causes material damage. EXCEPTION FROM MIDWIFE RESPONSIBILITIES Article 19 A midwife may not carry out duties not within her competence and which can directly or indirectly cause damage to the patient. Article 20 If a patient consciously refuses the practiced procedure or the application of practised therapy, the midwife shall immediately inform the authorised doctor. Article 21 A midwife shall not be responsible for an unexecuted procedure if, despite applying her best knowledge and skills, the employer has not provided the requested medication, devices, the minimal required instruments or technical equipment in accordance with the minimal standards for successfully carrying out midwife care. In case of inability to carry out the practiced procedure referred to in paragraph 1 of this Article, the midwife shall immediately inform her superior in written. 5

Article 22 A midwife shall be responsible for minor and major misconduct as determined in this Act and in the general acts of the Croatian Chamber of Midwives before the disciplinary bodies of the Croatian Chamber of Midwives. Disciplinary measures for minor and major misconduct of midwives shall be determined by the Croatian Chamber of Midwives. The provisions of the Act on Criminal Procedures shall apply appropriately to the disciplinary procedures against midwives in the part not prescribed in the general act of the Croatian Chamber of Midwives. VI. QUALITY CONTROL Article 23 The control of the quality of carrying out midwife duties shall be carried out by a specially educated midwife as a member of a team appointed by the employer in cooperation with the ministry competent for health care and the Croatian Chamber or Midwives. The control of the quality of work of midwives particularly includes: the plan of midwifery, carrying out the procedure of midwifery, the results of midwife care and the effect of midwife care on the health status of patients. VII. PRIVATE PRACTICE Article 24 Private practice may be carried out only by a midwife who has completed the study referred to in Article 14 paragraph 1 of this Act with approval for independent work issued by the Croatian Chamber of Midwives. The provisions of the Health Care Act shall apply to the process of founding, temporary suspension and cessation of work of a private practice. VIII. CROATIAN CHAMBER OF MIDWIVES Article 25 The Croatian Chamber of Midwives (hereinafter: Chamber) shall be the professional independent organisation of midwives with the capacity of a legal person and with public authorities. The Chamber shall promote, represent and harmonize the interests of the midwives before state and other authorities in the Republic of Croatia and abroad. Membership in the Chamber shall be obligatory for midwives. The Chamber shall have its own coat of arms, sign, seal and stamps. The headquarters of the Chamber shall be in Zagreb. Article 26 The Chamber shall carry out the following public authorities: keep a register of its members, provide, renew and withhold approvals for independent work, carry out professional monitoring of the work of midwives. The method and conditions for carrying out the professional supervision referred to in paragraph 1 subparagraph 3 of this Article shall be prescribed by the Chamber in a general act in agreement with the minister competent for health care. Article 27 6

In addition to the public authorities referred to in Article 26 of this Act, the Chamber shall carry out the following activities: 1. adopt the midwife ethical codex, 2. cooperate with the ministry competent for health care in all fields of midwife interest and provide professional opinions when preparing the regulations affecting the profession of midwives, 3. adopt the contents of the protocol for the plan and for carrying out midwifery activities, 4. propose the standards and norms for midwifery activities to the minister competent for health care, 5. identify the need, contents and duration of the additional training programme for midwives, 6. adopt a general act determining the contents, period and the process of continuous professional training and the examination of proficiency of midwives, 7. propose the contents of the midwife list to the minister competent for health care, 8. regulate the method and conditions for carrying out the professional supervision of midwifery, 9. determine the minimum prices for specific work in the midwife profession outside the basic network of health care, 10. determine the prices for individual work in the midwife profession in voluntary health insurance, 11. carry out professional supervision over the work of midwives, 12. determines midwife misconduct, 13. determines the disciplinary measures for minor and major midwife misconduct, 14. carries out the disciplinary procedure and imposes disciplinary measures for midwife misconduct, 15. cooperates with the health inspection of the ministry competent for health care, 16. represents the interests of midwives, 17. cares for the legal aid of its members, 18. cares for the other interests of its members, 19. coordinates the relations among members and actively participates in resolving potential disputes, 20. cooperates with the World Health Organization and other international organisations of interest to midwifery, 21. carries out other work as established in this Act, the Statute and other general acts of the Chamber. Article 28 The Chamber shall have a Statute. The Statute is the basic general act of the Chamber adopted by the Chamber Assembly. The minister competent for health care provides consent for the Chamber Statute. The Chamber Statute shall contain provisions on the following: name and headquarters, area on which the Chamber is active, the internal organisation, the bodies of the Chamber, their structure, authorities, method of decision-making, conditions and the method of selection and withdrawal, the duration of mandates and the responsibilities of members, the assets and the use of potential profits, the method of acquiring assets, the realisation of publicness of the Chamber's work, the membership and membership fee, the rights, obligations and disciplinary responsibility of the members, the cessation of work of the Chamber and actions related to assets in case of cessation of work. Article 29 The founder of the Chamber shall be the Ministry of Health and Social Welfare and the Croatian Association of Midwives. Article 30 Monitoring the legality of the Chamber in carrying out its public authorities shall be carried out by the Ministry competent for health care. In carrying out the monitoring referred to in paragraph 1 of this Article, the ministry competent for health care may request the appropriate reports and data from the Chamber. The reports and data referred to in paragraph 2 of this Article shall be delivered by the Chamber to the ministry competent for health care within 30 days, or it shall inform that ministry of any reasons why 7

it is not able to deliver said reports and data. The Chamber shall submit an annual report to the ministry competent for health care no later than 1 March of the following year for the previous year. Article 31 The Chamber shall inform the ministry competent for health care, other state administration bodies and the competent local and regional self-government bodies, at its own initiative or at their request of the state and issues in carrying out the activities of midwifery and on the measures that should be undertaken in order to improve the activities of midwifery and to improve the health care of citizens. The Chamber shall cooperate with state authorities and local and regional self-government bodies in solving issues regarding the activities of midwifery. The Chamber shall decide on cooperating with other healthcare worker chambers in the Republic of Croatia and with chambers of midwives in other countries. Article 32 In order to achieve its goals and realise its tasks, the Chamber shall acquire funds from: registration fees, membership fees, other revenue realised from the activities of the Chamber. The funds to carry out the work referred to in Article 26 paragraph 1 subparagraph 3 of this Act which the Chamber carries out based on public authority shall be provided from the state budget of the Republic of Croatia. IX. PENAL PROVISIONS Article 33 A midwife shall be fined from HRK 3,000.00 to 10,000.00 for misdemeanour if she: 1. fails to fulfill the obligation of keeping a professional secret (Article 3 paragraph 3), 2. carries out the activity of a midwife as a leader or member of a team if she is not registered in the Register (Article 14 paragraphs 1 and 2), 3. carries out independent work without an approval for independent work (Article 15 paragraphs 1 and 2), 4. in case of inability to carry out the practiced procedure does not inform her superior in written immediately (Article 21 paragraph 2), 5. prevents or disrupts professional supervision (Article 26 paragraph 2), 6. does not remove the deficiencies as determined by professional supervision. X. TRANSITIONAL AND FINAL PROVISIONS Article 34 The Ministry of Health and Social Welfare and the Croatian Association of Midwives shall found the Chamber within 6 months from this Act entering into force. The minister competent for health care shall, in cooperation with the Croatian Association of Midwives, appoint a founding committee of the Croatian Chamber of Midwives within three months from this Act entering into force. The Chamber shall adopt the general acts as prescribed in this Act and in the Chamber Statute within six months from its founding. Article 35 8

The regulations for whose adoption the minister competent for health is competent in accordance with this Act shall be adopted within six months from this Act entering into force. Article 36 Midwives who have a university degree in accordance with prior valid regulations, and who carried out the activities of midwifery for the past ten years before this Act entering into force, may still carry out those activities provided that, in accordance with this Act, they acquire the approval for independent work within two years. Article 37 This Act shall enter into force on the eighth day from its publication in the Official Gazette, except for Article 14 paragraph 4 of this Act which enters into force on the day of accession of the Republic of Croatia to the European Union. Class: 500-01/08-01/05 Zagreb, 3 October 2008 THE CROATIAN PARLIAMENT 9