UNOFFICIAL TRANSLATION. NATIONAL PROGRAM FOR CERVICAL CANCER PREVENTION organized screening program -

Transcription

1 UNOFFICIAL TRANSLATION NATIONAL PROGRAM FOR CERVICAL CANCER PREVENTION organized screening program - BELGRADE, 04 th March 2009

2 Contents 1. Situational survey 1.1. Cervical cancer epidemiology 1.2. Legal regulations 1.3. Organization of services for women healthcare 1.4. Staff capacities and level of equipment 2. Priority problems 3. National program objectives 4. Managing and coordination of National Program activities 5. Screening program 5.1 Methodology 5.2. Informing, education, communication and social mobilization 5.3. Identifying target population 5.4. Delivery of invitations 5.5. Organization of testing 5.6. Cytological check 5.7. Sending patients for further diagnostics and treatment 5.8. Data collection and information system 5.9. Program implementation indicators (process and outcome) 6. Monitoring and evaluation of National Program implementation 7. Financing National Program activities ENCLOSURES 1. Action Plan Terms and abbreviations 3. Cervical cancer epidemiology 4. Health workers in women healthcare per counties 5. Prerequisites for National Program implementation 5.1. Standards for staff, space and equipment 5.2. Staff education 6. Expert-methodological instruction for taking smears 7. Expert-methodological instructions for working in cytology laboratory 2

3 8. Cytology report form 9. Protocol for monitoring women after receiving cytology check results 10. Cervical Cytology School Program 11. Narrow specialization program: Clinical Cytology 12. Informing, education, communication and social mobilization 13. Survey of documents and literature. The cervical cancer represents a global problem - especially in the developing countries. According to the World Health Organization data, our country has the biggest incidence of cervical cancer in Europe. By observing this problem as one of priorities, the Ministry of Health of the Republic of Serbia has on 03 rd July 2006 established Special Working Group for Cervical Cancer Prevention the task of which was, among else, to compile a National Cervical Cancer Prevention Program. Bearing in mind the importance of the problem and the fact that in Serbia practically every day one woman dies from cervical cancer, the Working Group has, respecting the recommendations of the WHO, analyzing the screening programs of other countries and using experiences from Pilot Project in Branicevo County, compiled a Program that should enable beginning of cervical cancer screening also in our country. This Program has been adopted by the Government of the Republic of Serbia and it has been published in the Official Gazette no. 54 dated 23 rd May On the fourth of April 2008 the Minister of Health has established Republic Expert Commission consisting of Special Work Group with a few new members, with the basic task to implement the adopted National Program for Organized Screening. The Program participants are facing a very responsible and complex task to organize and implement successful screening with limited finances. Our country has enough of gynecologists and other medical staff for screening implementation. By introducing organized screening, partial transformation of health service organization shall also be performed, modeled upon the countries successful in screening implementation. That primarily pertains to education of cyto-screeners and organization of cytology laboratory service. Another positive factor in fight against cervical cancer is that in the meantime a vaccine against the most frequent types of human papiloma viruses causing this type of cancer has been discovered and registered. The National Cervical Cancer Prevention Program is harmonized with the World Health Organization recommendations, the objective of which is early cervical cancer discovery, adequate diagnostics and therapy in order to decrease mortality and improve quality of life of woman". 3

4 Members of the Special Working Group 1. Chairman: Professor Dimitrije Segedi Ph.D., Gynecology and Obstetrics Clinics Novi Sad 2. Vice-Chairman: Doc. Zivko Perisic, Ph.D., Gynecology- Obstetrics Clinic Narodni front", Belgrade 3. Secretary: MA of Med.Sc. Vesna Dragicevic, MD, City Public Health Institute, Belgrade, Bojana Milosevic, MD (EPOS) 4. Members: Professor Vesna Kesic, Ph.D., Institute for Gynecology and Obstetrics, Clinical Center of Serbia, Belgrade Professor Zivka Eri, Ph.D., Institute for Lung Diseases of Vojvodina, Sremska Kamenica Mirjana Djokic, Physician, Military-Medicine Academy, Belgrade MA of Med.Sci. Ana Bekic-Jovicevic, MD, Institute for Oncology and Radiology of Serbia, Belgrade Prim. Mirjana Velimirovic, MD, Medical Center Savski Venac", Belgrade Svetlana Milenkovic, MD, Institute for Gynecology and Obstetrics, Clinical Center of Serbia, Belgrade MA of Med.Sci. Nevenka Pavlovic, MD, City Public Health Institute, Belgrade 4

5 1. SITUATIONAL SURVEY 1.1. Cervical cancer epidemiology Situation in the world Cervical cancer is the second frequent malignant disease of women in the world, with around 490,000 newly-registered cases every year. Over 80% of cervical cancer cases, as well as deaths due to this disease are registered in the developing countries. There are dramatic differences in the rate of incidence in the world, from 2 cases per 100,000 women in Syria, to 87.3 per 100,000 women in Haiti (rates have been standardized per age groups). Cervical cancer - one of priority public health problems in Serbia According to the data of Cancer Register of Central Serbia and Register for Malignant Tumors in Vojvodina, in the territory of Serbia (without Kosovo) every year around 1400 new cases of cervical cancer are discovered. It is the second most frequent malignancy in women, after breast cancer. Standardized rate of cervical cancer incidence in Central Serbia in 2002 was 27.2 per 100,000 women, representing the highest rate of incidence in Europe. Similar high rates are marked in Rumania, Albania and Bosnia and Herzegovina. According to the data of the Statistics Bureau of Serbia, in women died of cervical cancer. Standardized death rate was 7.2 per 100,000 women and is lower than the rates in the quoted neighboring countries. Disease stadium represents the main forecasting factor in patients with cervical cancer. According to available data, less than one third of cervical cancer cases are detected in early invasive phase, when just surgical treatment can be successful. In most of the patients those stadiums are more developed, when it is necessary to apply post-surgical or radical radiotherapy which prolongs disease, can lead to different complications and significantly increases the costs of treatment. (Enclosure 3.) Cervical cancer -possible causes and prevention Regional differences in rates and trends of developing cervical cancer are contributed to by several factors. Infection with Human Papiloma Viruses (HPV), sexually transmitted is considered the main etiological factor and it represents necessary, but not sufficient condition for cervical cancer occurrence. Smoking and immuno-supression are two most important cofactors in pathogenesis of cervical cancer. However, frequency of cervical cancer greatly depends on one another factor, and that is existence and success of the screening program in the observed population. The screening program enables not only detection of cervical cancer in an early phase, but also discovering pre-cancerogenous lesions, by elimination of which malignant changes development is prevented. The basic screening test is Papanicolaou test. Mostly in developed countries, in which the screening programs are successfully implemented already for a couple of decades, dramatic drop in incidence of cervical cancer mortality has been marked.

6 1.2. Legal regulations Healthcare system and organization of health service have been regulated by the Healthcare Act (Official Gazette of the RS, number 107/2005) (hereinafter the Law). Healthcare in the sense of this Law covers implementing measures for maintaining and enhancing the health of citizens, prevention, suppression and early detection of diseases, injuries and other health disturbances and timely and efficient treatment and rehabilitation (Article 2). Healthcare in the Republic of Serbia consists of healthcare institutions and other forms of health service (private practice), established in order to secure healthcare, as well as the health workers, that is, healthcare collaborators, performing healthcare activity in line with this Law (Article 6). According to the same Law the healthcare activity is performed on the primary, secondary and tertiary level (Articles 79, 88, 89, 90, 91). According to the provisions of the quoted Law, the citizens shall exercise their primary healthcare in medical centers through their chosen physician, and for the population of women older than 15, besides medical doctor from the adult healthcare service, chosen physicians are also specialists of gynecology and obstetrics. Contents of work of the selected physician, Specialist of Gynecology and Obstetrics have been defined by the Healthcare Act, Rulebook on Conditions for Performing Healthcare Activity in Healthcare Institutions and Other Forms of Health Services, Rulebook on Conditions and Method of Internal Organization of Healthcare Institutions, Rulebook on Scope and Contents of the Right to Healthcare from Mandatory Health Insurance and about Participation for the Year 2007, Rulebook on Amendments of the Rulebook on Conditions, Criteria and Metrics for Closing Contract with Healthcare Services Providers and for Determining Compensation for Their Work in 2007, and by the Rulebook on Method and Procedure for Exercising the Rights from Mandatory Healthcare Insurance and about Participation for 2007 (Official Gazette of the RS 1/2007 and 52/2007). In the procedure for exercising healthcare in the medical center, the chosen physician shall implement all activities defined by the Healthcare Act (Articles 95, 98, 99) including also organizing and implementing measures for maintenance and enhancing the health of women, checks for diagnostics and timely treatment as well as sending patients to the secondary and tertiary level. According to the Law on Health Insurance (Official Gazette of the RS 107/2005) insured persons provided with healthcare in full amount are also insurees older than 65 years of age (Article 22 paragraph 3). According to the Rulebook on Scope and Contents of the Right to Healthcare from Mandatory Health Insurance and Participation for 2007, the Republic Health Insurance Bureau guarantees the right to targeted check for early cervical cancer detection once a year, to all women age from 20 to Organization of healthcare services for women Medical center is a health institution where healthcare activity is performed on primary level, and where at least preventive healthcare is organized for all categories of inhabitants, urgent medical assistance, general medical practice, healthcare of women and children, field service, as well as laboratory and other diagnostics (Healthcare Act, Official Gazette of the RS number 107/2005, Articles 94, 95).

7 The same Law regulates healthcare jobs on primary level, which among else cover prevention, early detection and control of malignant diseases. Health institutions on this level also cooperate with the other health, social and other institutions and organizations for preparing and execution of health maintenance and improvement program (Article 88). In medical center (and other primary level healthcare institutions) one can also perform specialist - consultancy activity. In that case, the medical center shall be linked in expert or organizational sense with adequate healthcare institution performing secondary healthcare activity (Article 89). In the Republic of Serbia there are 157 medical centers with healthcare units in the network. Hospital is a health institution performing healthcare activity on secondary level (Article 110). Healthcare of women on this level is performed through specialist-consultancy and stationary healthcare from gynecology and obstetrics (Article 111). Healthcare on this level covers more complex measures and treatments for detecting disease and injuries, as well as for treatment and rehabilitation of sick and injured (Article 90). Healthcare of women on tertiary level is rendered in clinics, institutes, clinic-hospital centers and clinical centers (Articles 115, 116, 117, and 118). Institutes and public health institutes as healthcare institutions performing healthcare activity on several levels (Articles 119, 120, 121, 122) are responsible for planning, monitoring and implementation of special healthcare programs defined by the Ministry of Health of the Republic of Serbia. Cervical Cancer Screening Program is one of priority programs of the Ministry of Health of the Republic of Serbia, and it is necessary to have participation of all defined healthcare levels for implementation of which. Service for healthcare of women exists in all medical centers, independently if they are independent healthcare institutions, or if they belong to health centers. The internal organization of these services hasn t been clearly defined not in one of the regulations or bylaws. The usual practice is to divide the work of the counseling office for pregnant women in time and space from the other segments of work of this service, which is in line with the Expert Methodological Instructions for Implementing Ordinance on Healthcare of Women, Children, Preschool Children and Students (Official Gazette of the RS 49/95) which is still implemented. Cervical cancer screening can be implemented by setting aside space and time only for these activities, which depends on spatial and staff capacities of the service, pending that access to patients who are coming for other diagnostics or treatment should not be limited Staff capacities and level of equipment Service for healthcare of women on primary level (in medical center) secures out-ofhospital healthcare of women in the population older than 15 years. According to the data from the Institute for Public Health of Serbia (Health-Statistics Yearbook of the RS for 2005) in our Republic gynecological medical services are rendered by 539 physicians, out of which 505 (93.7%) physicians specialists of gynecology and obstetrics. There are 6043 women older than 15 years of age per one physician in the service for healthcare of women (Enclosure 4 - Health workers in services for healthcare of women per counties). On the other healthcare levels there are additional 662 specialists of gynecology and obstetrics and 135 physicians specialists of pathological anatomy.

8 2. PRIORITY PROBLEMS 1. High rate of cervical cancer incidence in Serbia 2. Discovery of cervical cancer in later stadiums and high mortality rate from this disease 3. Insufficient level of information of women regarding efficiency of preventive measures for cervical cancer 4. Low coverage of target women population with regular Papanicolaou checks 5. Failure to include cervical cancer prevention among priorities of public-health problems in Serbia 6. Lack of harmonization of sequence of using services on various healthcare levels in Serbia 7. Insufficient training of the existing staff for implementing screening 8. Lack of necessary equipment and space 9. Non-existence of information system for supporting implementation of the National Cervical Cancer Screening Program (hereinafter the National Program) 10. Insufficient inclusion of the local community in activities for enhancing the health of women 11. Lack of means for financing organized screening within the National Program. 3. NATIONAL PROGRAM OBJECTIVES General objective Decrease of incidence and mortality of women from cervical cancer in Serbia. Specific objectives Raising consciousness of women regarding importance of regular checks and early detection of changes on cervix and informing them about the importance of screening Securing support to the National Program on state level Defining the role of institutions on all healthcare levels in prevention and treatment of cervical cancer Strengthening healthcare institutions capacities for National Program implementation (securing sufficient number of trained staff and equipment) Establishing system for collecting and managing National program data Establishing quality control for cervical cancer prevention services Inclusion of local communities and non-governmental sector in National Program implementation. 4. MANAGING AND COORDINATION OF THE NATIONAL PROGRAM ACTIVITIES Cervical cancer prevention covers a set of activities, among which central place occupies the Organized Screening Program. Cervical cancer screening shall be implemented on the territory of the Republic of Serbia in the form of organized decentralized program. 1. а) The Ministry of Health of the Republic of Serbia has, based on Article 23 of the State Administration Act (Official Gazette of the RS 79/05) and Article 22 of the Regulation on

9 Principles for Internal Regulation and Systematization of Jobs in the Ministries, Special Organizations and Governmental Services (Official Gazette of the RS 95/05), formed a Special Working Group for cervical cancer prevention (hereinafter SWG). SWG has compiled a Proposal of the National Cervical Cancer Screening Program. b) The Ministry of Health of the Republic of Serbia has completed renaming of SWG into Republic Expert Commission (hereinafter REC). REC has an expert consultancy role in implementing and monitoring National program activities. Based on decision of the Minister of Health of the Republic of Serbia number / dated 4 th April 2008 REC has a task to: - Perform analysis of the existing staff capacities and level of equipment with adequate medical devices and devices for services for women healthcare in primary level healthcare institutions - compile a proposal for procuring equipment for additional equipping of health institutions according to priorities - compile a National Cervical Cancer Prevention Program - organized screening program - present Good Practice Guide for Cervical Cancer Prevention and to compile a plan for its implementation in the quoted institutions - propose national program of gynecologists education for early detection of changes on cervix (cyto-diagnostics) in cooperation with the Republic Expert Commission for Pathology and Cytology - define a deadline for beginning of the program, criteria and method of program evaluation - propose health institutions where education of gynecologists shall be performed, including also possible number of attendants of the education - compile a proposal of continuous education program for gynecologists - propose a method for recording, processing, interpreting and use of data resulting from screening implementation - propose criteria and a method for evaluating quality of rendered services - Propose promotional activities and a method for motivating women for regular use of protective measures in healthcare institutions on primary level. REC is also evaluating fulfillment of conditions for forming reference cytology laboratory and appoints a supervisor. c) The Ministry of Health of the Republic of Serbia has appointed within the Sector for Public Health and Programmed Healthcare a person responsible for National Program implementation. d) The Ministry of Health shall form the Office for Screening Cervical Cancer (hereinafter the Office). Activities of the Office for Screening shall define quality standards and perform quality control, compiles a financial plan on annual level for the needs of implementing screening and a proposal for distribution of funds to Program participants. It envisages and organizes printing of uniform invitation letters, accompanying health-promotion material (leaflets, posters, etc.) and performs their distribution through the network of institutes and Public Health Bureaus. It shall lead a social mobilization campaign on the national level, including national media, postal service and other necessary subjects in screening s implementation. It is obliged to secure continuous two-way flow of data and information between all institutions /participants in the National Program. It shall form and, in cooperation with the Informatics

10 Service of the Public Health Institute Dr Milan Jovanovic Batut" (hereinafter PHI), it shall keep database for organized cervical cancer screening. This database contains necessary sets of data received during organized screening implementation from all healthcare institutions included in the Screening Program. Sets of data shall be contained in the software specially designed for the needs of National Program implementation. By installing this software in medical centers included in the Screening Program, efficient data collection shall be enabled (through the network of institutes and bureaus) into the formed database, as well as insight into activities and results of the Program. The Office shall analyze final data from the Organized Cervical Cancer Screening Database, which shall be delivered to the Ministry of Health (Sector for Programmed Healthcare and REC). The Office shall compile periodic reports about implemented activities, envisaged by the National Program and it shall deliver them to the Ministry of Health (Sector for Programmed Healthcare and REC). Periodic reports shall be compiled based on reports received from PHI. The Office shall collect, analyze and propose measures for improving staff capacities and equipment necessary for National Program implementation. The Office shall also compile a Plan and a Report on Financial Operations, which it shall deliver to the Ministry of Health of the Republic of Serbia. 2. Institute for Public Health Dr Milan Jovanovic Batut" coordinates activities of the institutes and public health bureaus included in the National Program. Information system of this institution shall secure informatics support in National Program implementation, in the sense of collecting data from county institutes /bureaus in electronic form, updating Database for Organized Cervical Cancer Screening and forwarding data from the base to the Office for Screening (once a month). Based on periodic reports on activities implemented within the National Program that the regional institutes and bureaus shall deliver to a specially appointed person in the Service for Planning and Organization of PHI, report shall be prepared for the Screening Office and for the Ministry of Health (every six months). All data on newly-discovered cases of cervical cancer during organized screening implementation shall be regularly delivered to the Center for Control and Prevention of Non- Contagious Diseases and PHI, in order to update Central Cancer Register database. 3. County institutes/ public health bureaus shall determine a representative (Epidemiologist, Welfare Specialist) in charge of implementation of the National Cervical Cancer Screening Program in the territory of the county for which they have been established. The selected representative shall participate in compilation of the Medical Center Operating Plan, performs expert consultation for the needs of implementing organized screening, processes data from periodic reports on performed activities from the screening program and data about discovered pre-cancerogenous changes and cervical cancer, received from the medical center and compiles reports for county territory. The county institutes/public health bureaus collect and forward to PHI two types of data: sets of data from medical centers in their territory, contained in specially designed software (once a month) and periodic reports on completed activities (every six months). 4. Medical center initiates, organizes and shall implement the National Program on the territory of the municipality it covers. These activities shall be performed in cooperation with

11 the county institute/public health bureau and local self-government (Person responsible for health in the local self-government). Medical center shall form a Group for Cervical Cancer Screening Coordination, consisting of: Management representative from the medical center (Manager, Senior nurse) Head of Service for Healthcare of Women in the medical center Senior nurse of the Service for Healthcare of Women in the medical center Specialist of Epidemiology, Social Medicine and Hygiene employed with the medical center, or manager of the Center for Preventive Health Services, if this has been formed within the medical center Senior Field Nurse of the medical center Local self-government representative (person in charge of healthcare). Group for Coordination of Screening in the medical center should before start of screening compile an Operation Plan Action Plan for its medical center. One should especially pay attention to those organizational procedures for which the screening methodology gives several opportunities, to select one and to state it in the plan. Among those treatments are: a precise method for delivering the invitation, a method for scheduling checks, organization of testing, place for performing cytological check, communication of results. Person responsible for keeping the database, appointed by the Group for Screening Coordination shall once a month deliver to the County Institute/ Public Health Bureau sets of data from the screening program in electronic form. Besides that, all data on newly discovered cases of cervical cancer during organized screening implementation shall be regularly delivered to the county institute/ public health bureau by registering the disease according to the valid regulations. Medical Center s Group for Screening Coordination shall write periodic reports on program implementation and deliver them to the county institute/public health bureau every 6 months, based on processing and outcome indicators. 5. SCREENING PROGRAM 5.1. Screening methodology Cervical cancer screening shall be implemented on the territory of the Republic of Serbia in the form of organized decentralized program. The screening program shall cover women ages from 25 to 69. Target group shall be identified using voting lists or bases of unique citizens identification numbers and lists of insurees from the Republic Health Insurance Bureau. Invitation for testing is delivered to all women from the target group. The testing means cytological cervical smear check (Papanicolaou test) according to the expert-methodological instructions. The screening interval is three years. Taking cervical smears shall be implemented by the Service for Healthcare of Women in the medical center.

12 Cytological checks of cervical smears are performed in cytology laboratory in the medical center itself, only for that medical center, or in one medical center for the whole county, or in laboratory within the medical center for the county, etc. Communicating results, determining the dynamics and contents of further monitoring, including sending for further diagnostics shall be implemented by the Service for Healthcare of Women in the medical center. 5.2 Informing, education, communication and social mobilization According to the Cervical Cancer Screening Program, before starting program implementation it is necessary to define strategy for informing, education, communication and social mobilization, operating plan for its implementation, time framework and to determine responsible persons for implementing the quoted activities in every medical center. Strategy for Informing, Education, Communication and Social Mobilization for Implementing Screening Program in the Area of Municipalities Covered by the Medical Center is the first document that should be written, and it represents a part of the Operating Plan Medical Center Action Plan prepared and adopted by the Medical Center Screening Coordination Group. The time frame for implementing one circle of the program is 4 years (3 years plus one year for women that haven t responded during the third year of screening) and for each year an operational action plan shall be written. (Enclosure 12. Informing, education and social mobilization) 5.3. Identifying target population Target population covers female citizens of Serbia age years. According to the Serbian Republic Statistics Bureau data (according to the census from 2002) this group covers women. Identifying the target group for screening shall be performed according to the quoted methodology in all municipalities in the territory of the Republic of Serbia (5.1. Screening methodology). Group for Cervical Cancer Screening Coordination in the medical center of any municipality shall appoint persons /team in charge of: - compilation of list of target population in its municipality (name, family name, year of birth, unique citizen s identification number, full residential address) - invitation plan compilation - forwarding the number of women envisaged for screening to the Office, in order to print the necessary number of invitation letters (according to prepared lists and invitation plan) - completing printed invitation letters received from the Office - establishing the records of sent invitations, delivered invitations and responses to the testing (The quoted activities shall be performed by the medical technician, according to the recommended standards, Standards for staff, space and equipment) Delivery of invitations

13 Group for Cervical Cancer Screening Coordination in the medical center of every municipality in Serbia shall, based on its list of target population and invitation plans compile a schedule for delivering the invitations. To each person from the list shall be delivered: 1. invitation letter containing the invitation for participation in the program with: - pre-set date and the time interval for performing checks with performance interval in the medical center and - telephone number for confirmation of arrival or change of term, 2. informative leaflet (short and simple information on objective and importance of screening). It is necessary to define time of taking smears, not only in the morning but also in the afternoon hours, in order to harmonize it with the personal and working obligations of women invited for screening. Coordination Group shall periodically (at 1 to 2 months) check response of women to invitations for screening, using database in which those data are recorded and which is also updated from time to time. Persons who haven t responded to the invitation after 2 months shall be sent the second, and if necessary, third invitation for screening. Organization for sending the first and successive invitations can be performed in cooperation with the field service of the medical center, with the local self-government s assistance (one should envisage agreement of the Ministry of Health with the Ministry of Telecommunications and the possibility to use free PTT services) Organization of testing On the quoted date, the person shall with the invitation letter, contact Service for Healthcare of Women in the medical center. The health worker in charge shall receive that person, take invitation letter, perform recording and direct that person to adequate physician. The medical center shall based on its staff and spatial possibilities organize screening implementation. Taking of cervical smears shall be done according to the expert-methodology instructions (Enclosure 6. Expert-Methodological Instructions for Taking Smears) Cytological survey Performing cytological check shall be done according to the expert-methodological instructions (Enclosure 7. Expert-Methodological Instructions for Work in Cytology Laboratory) Sending patients for further diagnostics Patient is sent for further diagnostics treatments into regional healthcare institution on secondary /tertiary level. With hysto-pathological finding the patient returns to the selected physician, who, depending on the type of diagnosed change, acts according to recommendations from the Protocol for Monitoring Women after Receiving Results of Cytological Check (Enclosure 9.). In order that the whole procedure would have full value and in order that it gives the right result, it is necessary to define clear authorities on different

14 levels of healthcare, as well as communication channels, paying full attention that the procedure should be simple for the patient, acceptable, understandable and minimally stressful. It is of extreme importance to secure adequate communication with the patient on every level. It covers communication of all possibilities for treatment and outcomes, and receiving informed consent of the patient for further treatment, as well as enabling her to ask questions in each phase of diagnosing and therapy Collecting data and information system In implementing organized population screening it is necessary to develop a software that would secure efficient program support. The software should contain sets of data on: - target population - sent invitations - response - test results - further diagnostics and therapy procedures. All data received on activities implemented during the organized screening shall be entered into the electronic database. Collection of data from the National Program has been organized in the following way: 1. Health worker in the medical center who receives the woman with the invitation, shall record in the Book of Screening Protocol (specially formed for the needs of the National Program), completes the header with general data in the form of Cytological Report (three copies) and sends her to the gynecologist. 2. The gynecologist completes a part of the form of Cytological Report pertaining to anamnesis, takes the smear and sends the marked fixed platelet together with the Cytological Report form to the cytology laboratory. 3. Cyto-screener shall check the platelet and complete the remaining part of the form. The platelets and report form shall be archived according to the methodology described in Enclosure The completed form of Cytological Report shall be delivered to the gynecologist who has taken the smear or to the chosen gynecologist, depending on the methodological treatment for which the medical center has opted during the organized screening planning. 5. The gynecologist communicates cytological check results and enters them into medical file. In case of suspicious PA findings, the patient shall be sent to her chosen gynecologist, who is further acting according to recommendations from Enclosure Data collected during screening implementation shall be entered into the medical center electronic database (software for the needs of screening implementation). Access to electronic database and data entry shall be performed by a person authorized by the Medical Center Coordination Group. 7. Data from medical center electronic database shall be delivered to the county institute / Public health bureau (for networking medical centers over the existing

15 informatics network, and for the others on CDs once a month), and from there to PHI and to the Office, in order to be entered into database of the Cancer Register and Database for Cervical Cancer Organized Screening. 8. During determining marks that would be present in the sets of data for delivery, one should obligatory respect the Law on Personal Data Protection (Official Gazette of FRY number 24/1998) Indicators of program implementation (process and outcome) Screening implementation process indicators are: - percentage of women who have responded to the invitation and reported to medical center after the first and later invitations - percentage of women who have performed the test - percentage of women who came to pick test result - percentage of inadequate tests - percentage of replies for further diagnostics and treatment - percentage of returned invitations - percentage of women who did not respond to the delivered invitations. Indicators for screening outcome are: - percentage of positive tests (PA III, IV or V) - percentage of patients with pre-cancerogenous changes (CIN-SIL) - percentage of patients with carcinoma and pato-hystological type - phase of disease in the moment of establishing the diagnosis. The quoted process and outcome indicators are elements for writing periodic reports on implemented activities on all levels, from the medical center to the Ministry of Health. Indicators for screening outcome form elements for planning further healthcare system activities, in order to decrease incidence and mortality from cervical cancer. 6. PROGRAM IMPLEMENTATION MONITORING AND EVALUATION Monitoring and evaluation shall be planned and implemented by the Office, with the assistance and participation of REC, based on the existing Organized Screening Database and periodic reports from the institutes and public health bureaus. Continuous entry and forwarding of data into electronic Organized Screening Database is obligatory for all participants authorized for this activity within the Program. Updating of the database shall be performed by Informatics Service of PHI of Serbia. The Office shall also organize periodic expert supervision over program implementation. Coordination Group in the medical center shall perform, based on process indicators, periodic (monthly) evaluation of all screening activities and it shall deliver reports to the county institute/public health bureau every 6 months. These reports shall be further sent to PHI and to the Office (Scheme 1).

16 All cases of cervical cancer that would be discovered using screening program shall be specially registered in the Cancer Register (Center for Control and Prevention of Noncontagious Diseases of PHI), in order to create conditions for evaluation of cancer incidence rates, with and without cases of this disease registered by screening. 7. FINANCING OF THE NATIONAL PROGRAM ACTIVITIES According to the Rulebook on Scope and Contents of the Right to Healthcare from Mandatory Health Insurance and about Participation for 2007, the Republic Health Insurance Bureau guarantees the right to targeted check for early detection of cervical cancer once a year to all women from 20 to 65 years of age. According to the Health Insurance Act (Official Gazette of the RS 107/2005) insured persons provided with healthcare in full amount are also insurees over 65 years of age (Article 22 paragraph 3). Costs of executing organized screening shall be covered from special budget line, which is negotiated every year, according to the proposed one-year financial plan. This special budget line covers additional costs for organized screening implementation: Establishing and work of the office Financing of REC for screening monitoring and evaluation Production and printing of promotional material and invitation letters Education of all screening participants according to the education plan delivered by the Office Procurement of necessary equipment and additional engagement of employees in the medical centers, institutes and public health bureaus Equipping and financing reference laboratories and staff included in the screening Software maintenance Securing funds for check, for uninsured persons who shall be covered by this check according to the screening program Other sources of financing can also be used for financing this program Republic Health Insurance Bureau shall cover additional costs of medical centers for performing screening operations. The Office shall prepare one-year financial plan for screening implementation, and present it to he Ministry of Health /the Minister.

17 ENCLOSURES ENCLOSURE 1. ACTION PLAN Financing of activities from the National Organized Screening Program The Government shall secure stable sources of financing for implementing activities and the National Screening Program. For these purposes all available financial sources shall be used, like: general budget, budget of the Ministry of Health and of other relevant ministries, funds of the Republic Health Insurance Bureau. Regardless of the method for financing selected by the Government, the funds shall be used only for agreed and defined activities envisaged by the Action Plan. Action Plan from 2008 to 2011 Action Plan for National Screening Program Implementation is given in the Table 1 of this Enclosure. The Office shall be responsible for action plan compilation for the next period, based on achieved results in the last year of the initial period (2011). ACTION PLAN from 2008 to 2011 Program objectives Strategies Activities Responsible bodies and time framework Securing prerequisites for adopting and implementation of the National Program 1. Securing administrative and operational apparatus for National Program implementation 1.1. Passing of the National Cervical Cancer Screening Program and publishing in the Official Gazette of the RS Establishing of the Office 1.3. Allocation of funds from the budget for Office work. Ministry of Health November 2008 Ministry of Health October 2008 Government of the Republic of Serbia, Ministry of Health Јануар Source of funding General budget /budget of the Ministry of Health for programmed healthcare General budget /budget of the Ministry of Health General budget /budget of the Ministry of Health for programmed healthcare Success indicators Relevant documents proving passing of the National Screening Program. The Program shall be published in the Official Gazette of the RS. Minutes of the Ministry of Health from the founding session of the NCSC. Relevant documents of the Ministry of Health proving allocation of finances for the needs of NCSC s work.

18 Program Strategies Activities Responsible objectives bodies and time frame 2. Securing staff capacities 3. Securing equipment 2.1 Education of cyto-screeners according to the proposed standards in the Program 2.2 Education of Pathologists -narrow specialization in Clinical Cytology for 5 reference cytology laboratories (2 laboratories in Belgrade, 1 in Nis, 1 in Kragujevac, 1 in Novi Sad /Sremska Kamenica). The Ministry of Health / School of Cytology GOC "Narodni front", Belgrade In totals 90 cyto-screeners in the period The Ministry of Health / Medical Faculty Novi Sad, In total 10 Specialist of Pathology in the period Additional education of The Office/Medical gynecologists, nurses and other centers /Institutes/ medical and non-medical staff in Public Health medical centers and county bureaus from institutes/public health bureaus for the January needs of Program implementation. 2.4 Education of administrative staff Medical centers / Institutes/ Public for the needs of Program Health bureaus implementation. from January -Presentation of the screening program Training for software usage. 3.1 Estimate of the level of equipment of offices in medical centers before start of the National Program implementation. 3.2 Equipping offices in medical center with equipment for taking cytological smears. Office/ Ministry. of Health, November Medical centers from January Estimate of the level of equipment The Office/ of cytology laboratories in medical Ministry of centers. Health, November Equipping of cytology laboratories in medical centers with the equipment for cytology checks of preparations (see standard equipment necessary for cytological check of the preparations). Medical centers, the Ministry of Health, from January Source of financing Medical centers independently, according to the estimated needs. Tertiary level institutions for healthcare in Belgrade, Nis, Kragujevac and Novi Sad. Medical centers. Medical centers / institutes/ Public health bureaus. The Office. Medical centers /local selfgovernment The Office. Medical centers /local selfgovernment. Success indicators Periodic report from the School of Cytology, number of trained cyto-screeners annually. Periodic report from the Medical Faculty in Novi Sad about subspecializations, that is, narrow subspecialization from Clinical Cytology. Number of seminars held in medical institution a year, for the needs of Program implementation, Number of health workers/collaborators who have attended additional educational programs. -Number of held seminars/annually in one of the medical centers-number of trained administrative workers. Report. on the level of equipment. List of necessary equipment per medical centers and plan of equipment distribution. Report. on the level of equipment. List of necessary equipment per medical centers and plan of equipment distribution. 3.5 Estimate of the level of equipment The Office/ of cytology laboratories in reference Reference institutions/the The Ministry of Health

19 institutions. 3.6 Equipping of cytology laboratories in reference institutions with equipment for cytology checks of the preparations. 3.7 Estimate of the level of equipment in medical centers with computer equipment. Ministry of Health. The Office/ The Ministry of Health /reference Institutions. Program Strategies Activities Responsible objectives bodies and time frame 4. Inviting women for screening 3.8 Equipping medical centers with computer equipment. The Ministry of Health. The Office/ The Medical centers /local selfgovernment. equipment. Report. on the level of Ministry of Health, November Source of financing Success indicators Medical centers, The Ministry of Health, from January Equipping NCSC The Ministry of with computer equipment, and Health. networking with Public Health Institute of Serbia "dr Milan Jovanovic Batut" Installation of software for the needs of National Program implementation Networking of medical centers out-of-network in informatics system of the network of institutes and public health bureaus Organization of sending the first and repeated invitations. 4.2 Defining the lists of women who shall be covered by screening, according to the National Program recommendations. 4.3 Plan of invitation shall be prepared on annual level (2008, 2009, 2010, for women that haven t responded in 2010). Medical centers / The Ministry of Health /local Self-government. The Ministry of Health / The Office. List of necessary equipment per medical centers and plan of equipment distribution. Report on furnishing NCSC with necessary computer equipment and software. Office. Office. Report on software installation -number of medical centers and institutes/ public health bureaus where the software has been installed. The Office/ The Office/ Institute for Public Ministry of Health. health of Serbia" dr Milan Jovanovic Batut". The Ministry of Health / Ministry of Telecommunicatio ns, December Medical centers /County institutes and public health bureaus give support January Medical centers /County institutes and public health bureaus give support March Agreement between the Ministry of Health with the Ministry of Telecommunications on the possibility to use free PTT services. Medical centers. 4.4 I Group of invited (in the first Medical centers Medical centers. year of organized screening): women /County institutes born from the 1 st January 1974, 73, and public health 72, 71, 70, 69, 68, 67, 66, 65, 64, bureaus give List of women who shall be covered with screening for 3 calendar years (2007, 2008, and 2009.) Plan of inviting women for four

20 63, 62, 61, conclusive with 31 st support. December II Group (in the second year of screening) Women born from the 1 st January 1979, 78, 77, 76, conclusive with women born on 31 st December In the same group also fall women born from the 1 st of January 1959, 58, 57, and 56, conclusive with women born on the 31 st December In the second year of screening all the other women should also be invited, who did not respond, from the I group of women invited for screening. III Group (in the third year of organized screening): Women born from the 1 st January 1984, 83, 82, 81, conclusive with women born on 31 st December In the third year of screening women born from the 1 st January 1949, 48, 47, 46, 45, 44, 43, 42, 41 should also be invited, conclusive with women born on 31 st December In the third year of screening shall be invited all women from the II group of women invited for screening that haven t responded. IV Group (in the fourth year of organized screening) all women from the III group shall be invited, who didn t respond in the previous year and women from I group shall be re-invited (I year of screening- age 1974, conclusive with 1960). 4.5 Delivery to the Office of lists of women who shall be invited for screening. 4.6 Printing and delivery of printed invitation letters to medical centers. Medical centers, March The Office, March Manufacture, designing and printing of posters, agitation The Office, cards/leaflets on importance of cervical cancer prevention. February Medical centers. The Office. The Office. successive calendar years (for 2007, 2008, 2009, 2010-for women that haven t responded in 2009). List of women planned for inviting for screening per years (for 2007, 2008, 2009, and 2010-for women who didn t respond in 2009). -Report on printed invitation letters -Plan of invitation letters distribution per medical centers. -Report on printed promotional materials. -Plan of promotional material distribution per medical centers and institutes / Public health bureaus. -Number of printed agitation cards

21 Program objective s 4.8 Manufacture of periodic reports on The Office performed activities during screening, /Institute for based on recommended process and Public health of outcome indicators for Screening Serbia dr Milan Program implementation. Jovanovic Batut" Per 6 months. Strategies Activities Responsible bodies and time frame B. Informing, education, social mobilization 5.1 National campaign for cervical cancer prevention Compilation of communication strategies for National campaign supporting National Program implementation. 5.2 Informing, education, social mobilization (IEC/СМ) on municipal level. The Ministry of Health / Office /Network of institutes and Public health bureaus, November, December The Ministry of Health / Office, October Medical centers /county institutes/ Public health bureaus. December The Office. Source of financing The Ministry of Health / and other ministries. The Ministry of Health / Office. The Office / Ministry of Health /Local selfgovernment. /leaflets. -Number of printed posters. -Periodic reports. Success indicators Report on achieved campaign objectives. Communication Strategy for the campaign. Report on Action Plan implementation, pertaining to informing, education and social mobilization per counties.

22 ENCLOSURE 2. TERMS AND ABBREVIATIONS Incidence - number of initiated episodes of illness and newly diseased persons during the given period in a certain population. Age specific rate of incidence - number of new cases of disease in defined age group per inhabitants of that age group. Standardized rates of incidence and mortality - represent fictitious values achieved by certain technical procedure, by introducing standard population (it is usually from the world or from Europe). They are used to overcome differences (most often per gender and age) existing in different populations, so that they are convenient for comparing. Screening - preliminary identification of unrecognized disease or defect by using tests, hearing or other procedures that can be quickly applied. Screening tests shall set aside seemingly healthy individuals who probably have a disease, from those who are probably disease free. FIGO- The International Federation of Gynecology and Obstetrics (Federation Internationale de Gynecologie et d'obstetrique). HPV - Human papilloma viruses. PA - Papanicolaou (test, method, classification). WHO - World Health Organization. REC- Republic Expert Commission for Cervical Cancer Prevention. NO- National Office for Cervical Cancer Screening. BCC - Benign cellular changes. ASC-US - Atypical Squamous Cells of Undetermined Significance. ASC-H- Atypical Squamous Cells - Cannot Exclude High-Grade Squamous Intraepithelial Lesion. AGUS - Atypical Glandular Cells of Undetermined Significance. AGC - Atypical Glandular Cells. AIS - Adenocarcinoma in situ. L-SIL - Low-Grade Squamous Intraepithelial Lesion.

23 H-SIL High-Grade Squamous Intraepithelial Lesion. CIN - Cervical Intraepithelial Neoplasia. HP - Hysto-pathological finding. ECC - Endocervical curettage. LEEP - Loop" electro-surgical excision procedure (loop excision). SCJ- Squamocollumnar junction IVP - Intravenous pielography CT - computerized tomography NМР - Nuclear magnet resonance PHI- Institute for Public health of Serbia Dr Milan Jovanovic Batut"

24 ENCLOSURE 3. Cervical cancer epidemiology Situation in the world Cervical cancer is second most frequent malignant disease in women in the world, with around 490,000 newly registered cases each year. Over 80.0% of cervical cancer cases, as well as deaths due to that disease are registered in the developing countries. There are dramatic differences in the rate of incidence in the world, from 2 cases per 100,000 women in Syria to 87,3 per 100,000 women in Haiti (rates have been standardized per age). The highest rates have been marked in the Eastern and Western Africa, Malaysia, Caribbean and Central America, the lowest rates have been marked in Eastern and Western Asia, Australia, North America, North and Western Europe (Graph 1). Graph 1. Rate of cervical cancer incidence in the world (rates have been standardized per age, according to the world standard population, per 100,000 women) Source: Ferlay J and сар. Globocan < 9.3 < 1G.2 < 26.2 < 32.G < 37.3 Regional differences in rates and trends of cervical cancer development are contributed to by several factors. Frequency of cervical cancer depends on sexual activity, because the infection with oncogenous types of human 24

25 papilloma virus (HPV) which is sexually transmitted is considered the main etiological factor. This infection represents a necessary, but insufficient reason for cervical cancer occurrence. However, frequency of cervical cancer largely depends on another factor, and that is existence and success of the screening program in the observed population. The screening program enables not only discovery of cervical cancer in an early phase, but also discovery of pre-cancerogenous lesions, by elimination of which appearance of malignant changes is prevented. The basic screening test is Papanicolaou test. In the countries, mostly developed ones, in which the screening programs are successfully implemented for already a couple of decades, dramatic drop in incidence and mortality has been marked for cervical cancer. Cervical cancer - one of priority public health problems in Serbia According to the data from the Cancer Register of Central Serbia and Register for Malignant Tumors of Vojvodina, in the territory of Serbia (without Kosovo) every year around 1400 new cases of cervical cancer are detected. It is the second most frequent malignant tumor in women, after breast cancer. Standardized rate of cervical cancer incidence in central Serbia was in per 100,000 women, which represents the highest rate of incidence in Europe. Similarly high rates are marked in Rumania, Albania and Bosnia and Herzegovina (Graph 2). Graph 2. Standardized rates of cervical cancer incidence in European countries in 2002 (rates have been standardized according to age, per 100,000 women) Source: Globocan I < 8.2 I < 10.4 < 13.3 < 16.2 <

26 According to the data of Statistics Bureau of Serbia, in women died of cervical cancer. Standardized death rate was 7.2 per 100,000 women and is lower than the rate in the quoted neighboring countries (Table 1). This difference could be explained by better availability and/or efficiency of institutions for cervical cancer treatment in Serbia. Table 1. European countries with the highest rate of death in 2002 (the rates have been standardized according to age, per 100,000 women) Source: Globocan 2002 and Serbian Statistics Bureau Standardized mortality rate Country Romania 13.0 Albania 9.8 Lithuania 9.0 Bulgaria 8.0 Bosnia and 8.0 Herzegovina Poland 7.8 Moldova 7.8 Macedonia 7.6 Latvia 7.4 Serbia 7.2 Hungary 6.7 Estonia 6.6 Russian Federation 6.5 Ukraine 6.4 Slovakia

27 Serbia per counties Rate of incidence of cervical cancer is higher in central Serbia than in Vojvodina. Besides that, there are also significant differences in incidence among counties in Central Serbia. In 2002, the lowest rates of incidence (16.6 per 100,000) have been marked in Macvanski County, and the highest, over two times bigger in Eastern Serbia, on the border with Rumania and in Belgrade (Table 2). Table 2. The rates of cervical cancer incidence in counties of Central Serbia in 2002 (rate of incidence has been standardized according to age per 100,000 women, 2002) Source: Cancer Register for Central Serbia County Standardized rate of incidence Zajecarski 38.1 Borski 37.1 Moravicki 32.9 Belgrade 32.5 Sumadijski 31.5 Jablanicki 30.7 Toplicki 29.1 Branicevski 28.3 Pcinjski 26.7 Podunavski 23.5 Zlatiborski 22.9 Pomoravski 22.1 Nisavski 21.3 Rasinski 20.9 Raski 20.9 Pirotski 19.5 Kolubarski 17.0 Macvanski 16.6 Stage of disease during diagnostics According to the available data, less than one third of cervical cancer cases are discovered in early phase of the disease (FIGO stage 0 or 1а). In most of the patients we have higher stadiums (Graph 3). 27

28 Stage of disease represents a main prognostic factor in patients with cervical cancer. Besides that, in higher stadiums post-surgical or radical radiotherapy is necessary, which prolongs treatment, can lead to early or late complications of irradiation and significantly increases the costs of treatment. Graph 3. Stage of disease (FIGO) in patients with cervical cancer in Belgrade in 2002 Source: Hospital Cancer Register of Institute for Oncology and Radiology of Serbia, and Cancer Register of Central Serbia IV 1% 0 / Ia 32% IIa Ib 26% Age distribution of cervical cancer in Serbia Risk for cervical cancer appearance increases with age. The biggest number of patients with developed disease is between 45 and 54 year of age. However, the disease can, although very rarely appear also much earlier, even before 20 th year of age (Table 3). Table 3. Age distribution of cervical cancer patients in central Serbia in 2002 Source: Cancer Register of Central Serbia Age-specific rate Years of age Number of cases % of all cases per 100,