<p> LAW ON EMERGENCY MEDICAL ASSISTANCE 1</p><p>I GENERAL PROVISIONS</p><p>Article 1</p><p>Emergency medical assistance (hereinafter: emergency assistance), as a special area of health care, performed at the primary level, is organized with the aim of undertaking a necessary and urgent medical intervention, where the failure of its undertaking would jeopardize the lives and health of citizens or cause a permanent damage and it is carried out in line with this Law and regulations on health care and health insurance. </p><p>Article 2</p><p>Emergency assistance is an urgent medical care for persons whose life, certain body organs or body parts are directly jeopardized due to sickness, suffering or injury, or for persons with whom, in a short period of time, the basic life functions, breathing or heart function are jeopardized, with the aim of maximally shortening the time from the appearance of the emergency state until their being completely taken care of, or sending for a further treatment. </p><p>Emergency assistance shall be provided on the spot, during the primary emergency transport, as well as un the emergency units, 24 hours non stop. </p><p>Article 3</p><p>Emergency assistance shall be done by the medical workers with an education from emergency assistance, in line with this Law. In cases of larger accidents and large-scale epidemics, the emergency assistance shall be carried out in line with a separate law. </p><p>Article 4</p><p>Certain terms, within the meaning of this Law, shall have the following meaning: </p><p>- ambulance with a life-support unit is a specially equipped ambulance emergency vehicle with a standardized medical-technical equipment; </p><p>- urgent transport vehicle is an emergency vehicle for an urgent transport of patients to the health service institution on the secondary and tertiary level; </p><p>- urgent transport of patients includes the organization and the way of transport of the patients from the spot to the nearest health service institution which provides health care on the secondary and tertiary level. </p><p>1 “Official Gazette of Montenegro“, No 49/08, dated on 15 August 2008 II EMERGANCY ASSISTANCE ORGANIZATION </p><p>1. INSTITUTE</p><p>Article 5</p><p>The Activity from Article 2 of this Law shall be organized and carried out by the Emergency Assistance Institute (hereinafter: the Institute). </p><p>Article 6</p><p>The Activities of the Institute are the following: - reception, examination and triage of patients by the emergency levels; - resuscitation and monitoring of the basic life functions; - observing patients’ condition after resuscitation; - administering appropriate therapy, primary treatment of wounds and injuries; - giving vaccines and serums in line with indication, antibiotics, analgesics, and other indicated drugs; - sending patients to the health service of secondary and tertiary levels; - medical observation of patients with the aim of potentially necessary additional diagnostic procedures in order to establish the precise diagnosis, - ultrasound and laboratory diagnostics; - stopping bleeding, treating fractures, immobilization; - giving advice to patients about their health state; - employees’ from the emergency assistance dispatching center receiving calls from citizens; - triage of calls by the emergency levels and sending the emergency assistance teams to provide the emergency assistance; - observing and analyzing the emergency assistance measures in Montenegro and reporting to the competent institutions; - shaping the doctrine in the area of emergency assistance; - proposing programs of emergency assistance measures from the scope of its work; - determining standard operative procedures for all the forms of emergency assistance and harmonizing the implementation of standards in providing emergency assistance; - participating in drafting and implementing certain health care projects in extraordinary situation; - continuous medical education for medical workers, medical associates, students, medical high school students and other staff; - cooperation with the Institute fro Public Health, health service institutions, the state administration agency in charge of internal affairs and police, the Army of Montenegro, Red Cross of Montenegro, operative protection and rescue units, domestic and international NGOs which deal with the emergency assistance, international professional medical institutions; - providing emergency security measures for public gatherings and sports manifestation, emergency transportation of the sick, within the country and abroad, by a vehicle, helicopter or plane; and - other activities in line with the Law and the act of establishment the Institute. </p><p>Article 7 2 The provisions of the Law on Health Care shall be applied to the establishment and work of the Institute, and to the other issues which are important for the functioning of the Institute, unless otherwise regulated by this Law. </p><p>Article 8</p><p>The Institute shall perform the activities from Article 6 of this Law through the organizational divisions: the units and subunits for emergency assistance. </p><p>Article 9</p><p>The Institute shall organize the units and subunits for emergency assistance based on the number of citizens, geographic specificity, traffic connections and distance from the hospital. </p><p>The units for emergency assistance shall be organized in: Bar, Berane, Bijelo Polje, Budva, Cetinje, Danilovgrad, Herceg Novi, Kolašin, Kotor, Mojkovac, Nikšić, Plav, Pljevla, Podgorica, Rožaje, Tivat, Ulcinj and Žabljak.</p><p>The subunits for emergency assistance shall be organized in: Andrijevica, Plužine and Šavnik.</p><p>In the areas where the number of health care users is increased due to transit and stay of tourists, the Institute can, at the approval of the state administration agency in charge of health affairs (hereinafter: the Ministry) and in cooperation with the competent agencies, temporarily open the emergency assistance subunits. </p><p>The Ministry shall prescribe the more detailed conditions regarding the space, staff and equipment, as well as the way of work emergency assistance units and subunits. </p><p>Article 10</p><p>Each emergency assistance unit and subunit shall have the necessary number of teams, ambulances with a life-support unit and vehicles for urgent transport. </p><p>The team in the emergency assistance unit and subunit shall consist of: a doctor, two nurses, or medical technicians, one of which shall drive the emergency vehicle. </p><p>The team for emergency transport in the emergency assistance unit shall consist of: two nurses, or medical technicians, one of which shall drive the emergency vehicle. </p><p>The Ministry shall prescribe the necessary number of the emergency assistance teams, ambulances with a life-support unit and the emergency transport vehicle in the emergency assistance unit and subunit, as well as the conditions regarding the technical characteristics of vehicles, medical and technical equipment of vehicles and the list of drugs used ambulances with a life-support unit and emergency transport vehicles. </p><p>Article 11</p><p>The doctor in the emergency assistance team shall conduct the examination and diagnostic procedures, determine and administer the therapy in line with the Protocol on diagnostic and therapeutic procedures in the emergency assistance and shall coordinate the work of the rest of the team. </p><p>The Ministry shall pass the Protocol from paragraph 1 of this Article. </p><p>3 Article 12</p><p>In all the cases when it is not possible to take care of the patient on the spot or in the emergency assistance unit, the doctor in the emergency assistance team shall, after the provided necessary medical assistance, send and transport the patient to the closest health service institution of secondary or tertiary level. </p><p>Article 13</p><p>The patients with the jeopardized basic life functions shall be transported by the emergency transport vehicle to the closest health care institution of secondary or tertiary, only accompanied by the doctor. </p><p>The patients who are transported and received in the health service institution from paragraph 1 of this Article, and with whom the hospitalization has not been indicated, can not use emergency transport vehicle while returning from the health service institution. </p><p>Article 14</p><p>The medical workers from the Institute shall be bound to wear the working clothes of single design marked with the international symbol of emergency assistance. </p><p>Article 15</p><p>The Institute shall organize and carry out the continuous education for doctors and nurses, or medical technicians for providing emergency assistance. </p><p>The Ministry, at the proposal from the Institute, shall prescribe the program and the way of carrying out the continuous education. </p><p>Article 16</p><p>Besides the obligatory records prescribed by a separate Law, the Institute shall be obliged to keep other records, in line with the Protocol from Article 11 of this Law. </p><p>2. DISPATCHING CENTER </p><p>Article 17</p><p>The provision of information and the forwarding of calls to the emergency assistance teams shall be done through the Dispatching Center for emergency assistance. </p><p>The Dispatching Center for emergency assistance (hereinafter: the Dispatching Center) shall be a part of the single communication center for all the emergency calls in line with the separate law. The information on emergency situations shall be provided by dialing 112. </p><p>4</p><p>Article 18</p><p>The Dispatching Center shall be located in the Institute. </p><p>Each emergency assistance unit shall have it dispatcher. </p><p>In cases when it is necessary to engage more emergency assistance units, from more municipalities, the Dispatching Center in Podgorica emergency assistance unit shall coordinate the work of the engaged emergency assistance units. </p><p>Article 19</p><p>The dispatcher shall receive the calls, determine the emergency level, forward the call to the emergency assistance units, inform the closest health service institutions of secondary or tertiary level about the arrival of the emergency patient, cooperate with the police, operative protection and rescue units and other adequate services. </p><p>If the dispatcher determines that it is not necessary to engage the emergency assistance team in the field, he shall be obliged to give the adequate instructions, in line with the Protocol from Article 11 of this Law. The dispatcher in the Institute shall be a doctor and a nurse, or a medical technician, and the dispatcher in the emergency assistant unit in other municipalities shall be a nurse, or a medical technician who is educated for providing emergency assistance, in line with this Law. </p><p>Article 20</p><p>The dispatching Center shall have a sufficient number of lines. </p><p>The connection between the ambulance and the dispatcher shall be established through a single connection system. </p><p>Article 21</p><p>All the conversations in the Dispatching Center shall be recorded and kept on an appropriate audio medium as a medical documentation, in line with a separate law. </p><p>Article 22</p><p>In cases where the activities of the emergency assistance teams is rendered difficult or dangerous, a rescue helicopter shall be engaged in the rescue, as well as the other equipment and devices of the state administration agency in charge of internal affairs and police, maritime safety and other agencies and services, which can offer adequate support to the emergency assistance teams in line with the standard operative procedures. </p><p>5 . </p><p>III FINANCING EMERGENCY ASSISTANCE</p><p>Article 23</p><p>The funds needed for emergency assistance shall be provided from the budget of Montenegro, the Republican Fund for Health Insurance and other sources, in line with this Law. </p><p>The work of temporary subunits for emergency assistance from Article 9 of this Law, as well as a number of emergency assistance teams above the determined number of teams shall be financed from the local self government funds. </p><p>IV SUPERVISION Article 24</p><p>The Ministry shall exercise supervision of the implementation of this Law and regulations adopted based on it. </p><p>Health inspectors shall exercise the inspection control from the Ministry competency in line with the Law. </p><p>V PENAL PROVISIONS Article 25</p><p>The Institute shall be penalized by a fine from thirty-fold to two hundred-fold amount of the minimal wage rate in Montenegro, if: </p><p>- it does not organize and carry out a continuous education (Article 15); - does not keep special records (Article 16); </p><p>The responsible person of the legal entity shall be penalized by a fine from ten-fold to twenty-fold minimal wage rate in Montenegro for the offense from paragraph 1 of this Article. </p><p>Article 26</p><p>The medical worker shall be penalized by a fine from ten-fold to twenty-fold minimal wage rate in Montenegro, if: </p><p>- he transports unaccompanied patient with the endangered basic life functions (Article 13 paragraph 1); - he does not wear working clothes (Article 14); - as a dispatcher, he does not act in line with the Protocol (Article 19, paragraphs 1 and 2). </p><p>VI TRANSITIONAL AND FINAL PROVISIONS 6 Article 27</p><p>The Institute shall be established within 12 months from the day this Law becomes valid. </p><p>Until the Institute is established, the emergency assistance shall be provided by the emergency assistance service in the medical center. </p><p>Article 28</p><p>On the day of its establishment, the Institute shall take over the existing space, equipment, vehicles and the employees in the emergency assistance services in the medical centers. </p><p>Article 29</p><p>By way of exception from the provision of Article 10 of this Law, the employee who, on the day when this Law became valid, was performing the driver’s duty in the emergency assistance service, shall make part of the emergency assistance team. </p><p>The employees from paragraph 1 of this Article shall be bound to finish the education for performing the emergency assistance affairs within 12 months from the adoption of the act from Article 15 of this Law. </p><p>Article 30</p><p>Until the establishment of the Dispatching Center, in line with this Law, the information on the need for urgent medical care shall be provided by dialing number 94. </p><p>Article 31</p><p>The Ministry shall adopt the by-laws for implementing this Law within 12 months from the day this Law become valid. </p><p>Article 32</p><p>This Law shall become valid on the eighth day from the day of its publishing in the “The Official Gazette of Montenegro”. </p><p>7 Statement of reasons</p><p>1. CONSTITUTIONAL BASIS </p><p>Constitutional basis for passing this Law is comprised in Article 16 paragraph 1 item 5 of the Constitution of Montenegro which prescribes that this Law, in line with the Constitutions, also regulates the other issues of interest fro Montenegro and in Article 69 paragraph 1 which prescribes that everyone has right to health care. </p><p>2. REASONS FOR ADOPTION The Law on Health Care (»The Official Gazette of the Republic of Montenegro, no 39/04_ has created a normative framework for the health system reform, as well as the reform of the primary level of health care, as a segment of the health system of Montenegro. Budući da je hitna medicinska pomoć djelatnost na primarnom nivou i njena organizacija podliježe reformi i shodno navedenom zakonu organizuje u skladu sa posebnim zakonom, radi preduzimanja neophodne i neodložne medicinske intervencije čije bi nepreduzimanje ugrozilo život i zdravlje građana ili izazvalo trajna oštećenja organizma. The concept of »personal doctor« which has been shaped by the health care reform enables the personal doctor to realize two »independent activities«, that is, makes it impossible for him, besides the authorizations regulated by Law and by-laws, to organize the providing of urgent medical assistance. Urgent medical assistance is of vital importance for health care functioning in any state. The current organization of this segment of health care showed deficiencies, first of all in availability as the basic principle of functioning of the health system of any state and the constitutional right of citizens. A small number of municipalities in Montenegro has a developed urgent medical assistance regarding space, equipment and personnel, while in a larger number of municipalities, there is a noticeable lack in space and equipment, and the personnel has been provided through overtime work of all the doctors. </p><p>As regards the local and regional distribution, the urgent medical assistance does not sufficiently cover the main roads where the urgent interventions and urgent transport are important for the injuries in traffic accident. In the same way, the issue of providing urgent medical assistance has not been resolved in scarcely populated and isolated areas, as well as in tourist places during the tourist season when there is also the problem of financing the urgent medical assistance. With the aim of improving and harmonizing the quality of urgent medical assistance in all the part of the country, it is necessary to establish a new system of urgent medical assistance which would unite the emergency services in each municipality, and which would be based on the planned needs for urgent interventions. In that sense, the plan is also to establish the Institute for urgent medical assistance which would unite the whole service of urgent medical assistance in the whole area of Montenegro, which would monitor the situation and the needs, and provide the unified standards of quality and equipment in all the municipalities and settlements, coordinate the work of the units and subunits for urgent medical assistance and secure a continuous education of the employees. Besides the mentioned things, it would also provide an urgent and fast transport, also including the transport by helicopter, in all the parts of the country and a systematic coordination with the hospital</p><p>8 resources, with the aim of a more quality action in urgent states, and it would also organize a necessary number of teams of urgent medical assistance on the main roads and tourist places during the summer and winter season. </p><p>3. ALIGNMENT WITH THE EUROPEAN LAWS AND THE APPROVED MEDICAL CONVENTIONS This Law is based on the recommendations of the World Health Organization and the approved European standards in the area of urgent medical care on the spot, Resolutions WHA 56.24 and WHA 57.10, and the Recommendation Rec (2006)7 of the Committee of Ministers to member states on management of patient safety and prevention of adverse events in health care. </p><p>4. LEGAL INSTITUTES EXPLANATION</p><p>A. Basic conceptual orientations By passing this Law, the urgent medical assistance will be organized in line with the recommendations of the World Health Organization and European standards in the area of urgent medical care on the spot, with clearly determined norms and ways of financing, which will, in the upcoming period, give visible results in achieving the quality of provided medical assistance in urgent situations, to all who need it, and will significantly increase the number of successful resuscitations in the field. Also, the comparative experiences from the countries from the region have been used, as well as from the developed countries of EU. The implementation of the foreseen legal decisions should make possible that in the whole are of Montenegro, it should not take more than 20 minutes to provide an adequate health care. </p><p>B Concrete solutions</p><p>I GENERAL PROVISIONS (Articles 1 - 4) the goals and subject of the regulation of this Law have been determined, as well as the meaning of certain terms. </p><p>II EMERGENCY ASSISTANCE ORGANIZATION (Articles 5 - 16)</p><p>1) INSTITUTE </p><p>In this part, the organization and the scope of activities of the Institute have been determined, and it is prescribed that the Institute performs the activities of emergency assistance, through the organizational parts, units and subunits for urgent medical assistance, within which the emergency medical assistance teams are active. Also, the local and sub local units for urgent medical assistance have been determined, depending on the number of citizens, geographic specificities, traffic connections and distances from the health service institutions, but also there is the prescribed possibility of establishing the temporary subunits in the areas where, due to the transit and presence of tourists, there is an increased number of health care users, as well as the number of teams above the number prescribed by the regulations. The same paragraph prescribes the composition of the emergency assistance teams, while the number of emergency assistance teams, ambulances with a life-support units and the vehicles for urgent transport, the conditions regarding the technical characteristics of vehicles, medical and technical equipment of vehicles, as well as the list of drugs used in ambulances and vehicles for urgent transport are prescribed by the state administration agency in charge of health affairs (hereinafter: the Ministry). Article 11 prescribes that the doctor in the emergency assistance teams conducts the examination, diagnostic procedures and administers the therapy in line with the Protocol on diagnostic and therapeutic procedures in HMP passed by the Ministry. Articles 12 and 13 prescribe that in all the situations when it is not possible to take care of the patient on the spot or in the emergency assistance unit, the doctor in the emergency team sends the</p><p>9 patient by an urgent transport vehicle to the closest health service institution of the secondary or tertiary level, and that the patients with endangered life functions are transported by urgent transport vehicle only accompanied by a doctor. Article 14 prescribes the obligation on the part of the employed in the emergency assistance to wear the working clothes of single design, marked with the international symbol of emergency assistance. Article 15 prescribes that the Law organizes a continuous education of medical workers for work in the emergency assistance. </p><p>2) DISPATCHING CENTER (Articles 17-22) The complete work coordination of the emergency assistance teams, information on events and forwarding calls is done through the Dispatching Center, which is, in line with the provisions of this Law, an organizational part of the Institute but also a part of the single operative communication system for all the emergency calls, organized in line with a separate law. </p><p>The provisions of this Law prescribe that for the emergency calls, 112 should be dialed. Article 19 prescribes the activities of the dispatcher upon the reception of the call, in line with the Protocol passed by the Ministry. The same Article prescribes that the personnel in the Dispatching Center in the emergency unit in Podgorica consists of a doctor and a nurse/medical technician, while in the emergency unit in other municipalities, the dispatcher can be a nurse/medical technician, educated for the work in the emergency assistance, in line with the provisions of this Law. Articles 20 and 21, with the aim of establishing a fast and unhindered communication, prescribe that the Dispatching Center has to have a sufficient number of lines, and that the connection between the ambulance and the dispatcher is established through a single communication system. Also, there is a prescribed obligation to record and keep, in the appropriate medium, all the conversations in the Dispatching Center. </p><p>Article 22 prescribes that, in cases when the action of the emergency assistance teams is rendered difficult or dangerous, a rescue helicopter is included in the rescue, as well as the other equipment and devices of the state administration agency in charge of internal affairs and police, maritime safety and other agencies and services, in line with the standard operative procedures. </p><p>III FINANCING EMERGENCY ASSISTANCE</p><p>Article 23 prescribes that the emergency assistance is financed from the budget of Montenegro, the Republican Fund for Health Insurance and other funds in line with the law, and there is also a possibility to establish a temporary subunit during the tourist season, with the participation of local self government, together with the teams above the determined number. </p><p>IV SUPERVISION</p><p>Article 24 prescribes that the Ministry exercises supervision of the implementation of this Law and the regulations which are adopted based on it, and that the inspection control affairs, from the Ministry's competence, are performed by a health inspector, in line with the law. </p><p>V PENAL PROVISIONS</p><p>Penal provisions (Articles 25 and 26) prescribe the fines for the offenses of violation of the obligations prescribed by this law. </p><p>VI TRANSITIONAL AND FINAL PROVISIONS</p><p>10 Articles 27 – 32 regulate certain issues of transitional regime. In that way, it has been determined that until the Institute is established, the emergency affairs will be performed by the emergency assistance services in the medical centers, and on the day of its establishment, the Institute will take over the existing space, equipment, vehicles and the employees in the urgent assistance services in the mentioned institutions. Also, the status of the employees, who have performed the driver's duty on the day this Law becomes valid, is regulated in a way that they make a part of the emergency assistance team, where they have a certain time framework within which they are bound to finish their education for the work in emergency assistance, in line with this Law. </p><p>5. FUNDS FOR IMPLEMENTATION OF THIS LAW </p><p>In order to implement this Law, it is necessary to provide the funds for building the Institute for urgent assistance building in Podgorica, for the adaptation of the emergency units and subunits space, and also the procurement of ambulances with a life-support unit, vehicle for urgent transport and other necessary equipment. </p><p>11</p>