TERMS OF REFERENCE

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					                TERMS OF REFERENCE


“IMPLEMENTATION OF THE NATIONAL SCREENING PROGRAMME FOR
        COLORECTAL, CERVICAL AND BREAST CANCER”

                  REPUBLIC OF SERBIA




                           1
1.      BACKGROUND INFORMATION ............................................................................................................... 4

     1.1.       Beneficiary country ............................................................................................................................... 4

     1.2.       Contracting Authority ............................................................................................................................ 4

     1.3.       Relevant country background ................................................................................................................ 4

2.      OBJECTIVE, PURPOSE & EXPECTED RESULTS .................................................................................... 5

     2.1.       Overall objective.................................................................................................................................... 5

     2.2.       Purpose .................................................................................................................................................. 5

     2.3.       Results to be achieved by the Consultant .............................................................................................. 5

3.      ASSUMPTIONS AND RISKS ...................................................................................................................... 7

     3.1.       Assumptions underlying the project intervention .................................................................................. 7

     3.2.       Risks ...................................................................................................................................................... 7

4.      SCOPE OF WORK ........................................................................................................................................ 8

     4.1.       General .................................................................................................................................................. 8

       4.1.1.           Project description ........................................................................................................................ 8

       4.1.2.           Geographical area to be covered ................................................................................................. 13

       4.1.3.           Target groups .............................................................................................................................. 13

     4.2.       Specific activities ................................................................................................................................. 13

       4.2.1.           Project component 1 Strengthening public health capacities ...................................................... 13

       4.2.2.           Project component 2 Strengthening human resources for cancer screenings .............................. 15

       4.2.3.   Project component 3 Assisting Ministry of Health in awareness raising and mobilisation
       campaign .................................................................................................................................................... 21

5.     Project management ...................................................................................................................................... 22

     5.1.       Responsible body................................................................................................................................. 22

     5.2.       Management structure ......................................................................................................................... 22

6.     LOGISTICS AND TIMING ......................................................................................................................... 23

     6.1.       Location ............................................................................................................................................... 23

     6.2.       Commencement date & Period of implementation .............................................................................. 23

7.     REQUIREMENTS ........................................................................................................................................ 23

     7.1.       Personnel ............................................................................................................................................. 23

       7.1.1.           Key experts ................................................................................................................................. 23
                                                                                     2
       7.1.2.           Other experts ............................................................................................................................... 27

       7.1.3.           Support staff & backstopping ..................................................................................................... 28

     7.2.       Office accommodation ........................................................................................................................ 28

     7.3.       Facilities to be provided by the Consultant ......................................................................................... 28

     7.4.       Equipment............................................................................................................................................ 28

     7.5.       Project Budget ..................................................................................................................................... 28

     7.6.       Incidental expenditure ......................................................................................................................... 28

     7.7.       Expenditure verification ...................................................................................................................... 29

     7.8.       Project visibility................................................................................................................................... 29

8.     REPORTS ..................................................................................................................................................... 29

     8.1.       Reporting requirements ....................................................................................................................... 29

     8.2.       Submission & approval of progress reports ......................................................................................... 30

9.     MONITORING AND EVALUATION......................................................................................................... 30

     9.1.       Definition of indicators ........................................................................................................................ 30

     9.2.       Special requirements ............................................................................................................................ 31




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    1. BACKGROUND INFORMATION
     1.1.       Beneficiary country

Republic of Serbia

    1.2.        Contracting Authority

EU Delegation (EUD) in the Republic of Serbia

    1.3.        Relevant country background

The health status of the population of the Republic of Serbia has shown unfavourable tendencies in the
last decades. This phenomenon has multiple origins, including the deterioration of the country‟s
economic performance during the nineties and after the millennium, and the consequent decline of
living standards for most people, the unfavourable demographic processes (aging of population, low
reproduction rate), and the social impact of the political changes in the last two decades (high number
of refugees, displaced persons).

The health care system of the country could not meet the challenges carried by the socio-economic
changes, the sustainability of health care financing required health care reforms. Serbia has a
compulsory health insurance scheme with an almost complete coverage of the population with health
insurance, and a dominantly state-owned organisational network of health care providers. The last
decade‟s reforms – under the circumstances of economic hardships, and consequently descending
income of publicly financed health insurance fund – aimed at financial sustainability, control of public
expenditures and efficiency gain in the health care sector.

To maintain the equal access to health services was a prominent goal of the reforms, and the social
health insurance scheme is considered as an essential tool to achieve it. However, the equal access has
become limited for certain groups of the society, mainly due to the financial restrictions – e.g. co-
payment system in health care – on the health care system. These groups – the poor, the Roma
population, elderly and marginalised groups – were disproportionately affected by the fiscal measures
aiming to control the utilisation of health care services.

Internationally funded projects were designed and implemented to support health care reforms in the
Republic of Serbia. Some of them were assistance programmes based on bilateral co-operation
agreements (EU, CIDA, UNICEF, JICA funds); some are implemented as loan scheme (e.g. World
Bank). In April, 2008 the Government of the Republic of Serbia has signed a financing agreement
with the European Commission on the IPA (Instrument of Pre-Accession) Assistance programmes in
order to strengthen reforms processes in the public administration and public services, furthermore to
support economic reforms and developing democratic institutions in Serbia.

Serbia has a high cancer mortality rate in European comparison, the standardized death rate of all
neoplasms was 205.87/100.000 in 2006, and the country was among the countries with the highest
cancer mortality in the WHO European region. The preventable cancer deaths considerably contribute
to the actual cancer mortality in Serbia, the breast, cervical and colorectal cancer mortality give a large
part of disease burden. The pilot projects has proven successful in mobilising people to participate in
cancer screening and, in the same time, faced the lack of organisational capacities of health care. For
details see chapter 4.1.1. of this Terms of Reference.



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2. OBJECTIVE, PURPOSE & EXPECTED RESULTS
     2.1.    Overall objective

The overall objective of the project of which this contract will be a part is to contribute into the
improvement of the health and well-being of the population of Serbia by supporting the
implementation of national cancer screening systems.

     2.2.    Purpose

The purposes of this contract are as follows:

    Project component 1.        To strengthen organisational and administrative capacities of the
       Serbian public health institutions, related to national cancer screening programmes by
       establishing and operating the National Cancer Screening Office and by training district public
       health institutes‟ staff participating in the operation of the cancer screening programmes at
       local level.

    Project component 2.       To strengthen human capacities of the Serbian health care institutions
       related to organised cancer screening programmes by training key staff participating in the
       operation of the national cancer screening programmes, namely: radiologists, radiographers,
       cytotechnicians, cytopathologists, gastroenterologists, and providing a sound methodological
       basis for their sustainable trainings, in order to maintain and develop concerned human
       resources.

    Project component 3.      To contribute into increasing participation rates in the organised
       cancer screening programmes by assisting national public health institutes in their efforts to
       train primary health care professionals on organised cancer screenings and, furthermore by
       assisting the Ministry of Health in its mobilisation campaign when organised screening
       programmes launched.

     2.3.    Results to be achieved by the Consultant

Project component 1 Strengthen public health capacities

1. established, operational and competent National Cancer Screening Office, working according to
   international public health standards;

2. 50 district public health institutes experts trained in cancer screening related basic epidemiology,
   principles of screening, methods of organisation, data collection, performance monitoring and
   evaluation, and local mobilisation techniques;

3. cost calculations in relation to cancer screening programmes, based on available epidemiological
   and clinical data, and assessment of health gain from cancer screening programmes at different
   participation rates.

Project component 2 Strengthen human resources for cancer screenings

1. a comprehensive training course material compiled to train radiologists on breast cancer screening
   and diagnostics in accordance with the recommendations and standards set by the European
   practices and guidelines, and 80 radiologists trained according to European standards in breast
   cancer screening and diagnostics;



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2. training on breast cancer screening and diagnostics is built into the continuous medical education
   system for radiologists and for radiographers, according to the existing legal regulation in the
   Republic of Serbia;

3. a comprehensive training course material compiled to train radiographers on breast cancer
   screening and diagnostics in accordance with the recommendations and standards set by the best
   European practices and guidelines, and 100 radiographers trained according to European standards
   in breast cancer screening and diagnostics;

4. a comprehensive training course material compiled to train cytopathologists on cervical cancer
   screening and diagnostics in accordance with the recommendations and standards set by the
   European practices and guidelines, 30 pathologists trained according to European standards in
   cervical cancer screening and diagnostics;

5. training on cervical cancer screening and diagnostics is built into the continuous medical education
   system for pathologists and laboratory assistants, according to the existing legal regulation in the
   Republic of Serbia;

6. a comprehensive training course material compiled to train cytotechnicians on cervical cancer
   screening and diagnostics in accordance with the recommendations and standards set by the best
   European practices and guidelines, and 100 cytotechnicians trained according to European
   standards in cervical cancer screening and diagnostics;

7. a comprehensive practice course material compiled to train gastroenterologists to perform
   colonoscopy in accordance with the recommendations and standards set by the international
   practices and guidelines, 50 gastroenterologists trained according to international standards in
   colonoscopy – especially in colorectal cancer diagnostics and therapeutic interventions
   (polypectomy);

8. training on colonoscopy is built into the continuous medical education system for
   gastroenterologists, according to the existing legal regulation in the Republic of Serbia.

Project component 3 Assist Ministry of Health in awareness raising and mobilisation campaign

1. teaching/educational material for short training – in 4-6 hours – prepared for district public health
   institutes staff in order to train and educate selected primary health care staff (dom zdravlja
   administrative staff, general practitioners and practice nurses) on tasks and techniques of effective
   participation in cancer screening programmes, with special regard to colorectal cancer screening,
   and on mobilisation their patients for screening;

2. district public health institutes staff trained and supplied with teaching/educational material on
   educating selected primary health care staff on participation in cancer screening programmes, with
   special regard to colorectal screening, and on mobilisation patients for screening;

3. assistance provided for the Ministry of Health to the mobilisation campaign in the form of printed
   information leaflet for patients, short information leaflets for primary health care staff.




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3. ASSUMPTIONS AND RISKS
      3.1.   Assumptions underlying the project intervention

       Organisational and human capacity is existing to organise cancer screenings in the district
        public health institutes;

       Readiness of all local stakeholders to participate actively in implementation of screening
        programmes.

       High level ministerial support and inter-ministerial cooperation exists in relation to national
        cancer screening programme implementation.

       Financial resources are available for continuing the screening programmes over the longer
        term, and financing mechanisms are worked out to enable health care institutions to provide
        high-quality cancer screening services on a sustainable basis.

       Adequate human resource capacity to conduct the screening programmes is available over the
        longer-term.

       Legal aspects of establishing National Cancer Screening Office are arranged, Ministry of
        Health initiates and carries out necessary legislative or legal measures.

      3.2.   Risks

       Organisation of national-level cancer screenings fails due to the lack of organisational and
        administrative capacities within the Ministry of Health, and therefore vital decisions are not
        made in the Ministry of Health;

       Key stakeholders, such as health care institutions, of the national cancer screening programme
        do not show interest in participating in the organised screening, due to lack of financial
        resources or clear and transparent financing mechanisms;

       A clear structure of rights and responsibilities of governing national cancer screening
        programmes is missing due to the capacity constraints in the Ministry of Health;

       High-level health policy support exhausted within a short period of time, because of the initial
        difficulties of launching national level cancer screening programmes;

       A sufficient number of radiologists or radiographers is not available taking part in trainings
        and for participating in breast cancer screening, thus increasing even further the shortage of
        human capacity in radiology;

       A sufficient number of pathologists or cytotechnicians is not available taking part in trainings
        and for participating in cervical cancer screening;

       A sufficient number of gastroenterologists is not available taking part in trainings and for
        participating in colorectal cancer diagnostics;

       Professional conflicts between public health profession and concerned further professions (e.g.
        radiologist, gastroenterologist, gynaecologist) and lack of consensus could prevent effective
        and wide implementation of cancer screening programmes, narrow group interests, partisan in
        nature, dominate national goals.

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4. SCOPE OF WORK
     4.1.     General

              4.1.1.   Project description

Serbia is among the countries with the highest breast and cervical cancer mortality rate in Europe.

Mortality due to the malignant neoplasms of breast was 29,64/100.000 in 2006), the number of deaths
exceeds 1.500 annually. However, Serbia has a relatively low breast cancer incidence rate in European
comparison (incidence 68,46/100.000 in 2005, resulting in more than 4.500 new cases every year).
According to the data of the National Breast Cancer Prevention Programme of the Republic of Serbia,
70% of new mammal carcinomas are larger than 2 cm when detected, and in more than 50% of all
cases the tumour has already spread into the regional lymphatic nodes, reached the skin, or has already
produced distant metastases. This phenomenon indicates the potential health gain from a well
organized early detection system in the country. The early diagnosis and treatment of breast cancer can
have a considerable effect to decrease the cancer-related preventable mortality and the better health of
the Serbian women.

The number of new cervical cancer cases is more than 1.700-1.800/year, the standardized incidence
rate was 24,8/100.000 in 2005. The high incidence rate is accompanied by one of the highest mortality
rate in Europe, in 2006 the standardized death rate (SDR, females, malignant neoplasm of cervix uteri,
per 100.000) was 9,98, the 3rd-4th highest among the European countries. In that year 481 women
died of the consequences of cervical cancer. Vast majority (more than 2/3) of new cervical cancer
cases were detected after the early invasive phase and the prognosis of these cases was poor
accordingly.

In the Republic of Serbia death rate attributed to the cancers of colorectal origin is relatively close to
that of the European countries, exceeding the EU average by 15% in male, and by 19% in case of
women. Still, colorectal cancers led to the death of 2.422 inhabitants of Serbia, of which 1.051 were
woman and 1.371 man in 2006. Thus, colorectal cancers are the second on the list of malignant
diseases causing cancer deaths in both genders. The number of new cases is approx. 3.800 per year.

To give a new momentum to the cancer control efforts in Serbia, the Ministry of Health has created
national programmes to co-ordinate the activity of involved stakeholders, and also to enhance their
professional, organisational and administrative capacities. These national programmes (namely the
breast, cervical and colorectal cancer prevention programmes) are making use of the advantages of
governmental support, and the high level endorsement of key professional and societal stakeholders.

In April 2008, the Government of the Republic of Serbia signed a financing agreement with the
European Commission on the IPA assistance (Instrument of Pre-Accession) in order to support the
efforts of Serbia to develop its public administration and services, democratic institutions, and also
carry out economic reforms. Within the frame of IPA assistance programmes – acknowledging the
governmental efforts aiming to decrease cancer-related disease-burden in Serbia, and also the
prominent professional quality of the abovementioned national documents – the “Implementation of
the National screening programme for colorectal, cervical and breast cancer” was identified as one of
the priorities to promote the health of the population of Serbia. The main aim of the project is to
support the implementation of organized screening programmes for breast cancer, cervical cancer and
colorectal cancer.

The project is divided into a Technical Assistance (TA) component, and an Equipment development
component. The TA component intends to enhance the professional and organisational capacities as
well as the administrative basis of the national cancer screening programmes, while the procurement

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of equipment will develop the infrastructure of the Serbian health care system, crucial to fulfil tasks
related to the national cancer screening programs.

The Technical Assistance is divided into three components:

       Project component 1 Strengthening public health capacities.

       Project component 2 Strengthening human resources for cancer screenings.

       Project component 3 Assisting Ministry of Health in awareness raising and mobilisation
        campaign.

The National Cancer Screening Office (NCSO) shall have a central role in the organisation,
monitoring and supervision of national cancer screening programmes: it will provide general
coordination and professional guidance for the district public health institutes‟ staff involved into local
organisation of cancer screening programmes. The NCSO shall maintain and operate the national
cancer screening database, furthermore will collect information and prepare reports on existing human
and infrastructural capacities, and prepares recommendations on capacity development, financing and
regulating screening programmes for the Ministry of Health. The NCSO will be the institutional basis
of quality assurance and performance monitoring for cancer screening programmes, evaluating and
monitoring the participating health service providers.

The NCSO is to be established as a unit of the Institute of Public Health (IPH) of Serbia “Dr Milan
Jovanović Batut”. As regards its professional activities, it shall be professionally independent, having
an Advisory Board appointed by the Minister, which supervises its activities.

The National Cancer Screening Office will carry out its activities according to the international
standards, with special regard to the recommendations of the International Agency for Research on
Cancer (IARC) and the International Association of Cancer Registries (IACR), and in close co-
operation with the relevant Serbian national institutes and professional bodies (e.g. National Institute
of Oncology and Radiology etc.).

The district public health institutes (there are 24 district + Beograd city under the authority of the
Government of the Republic of Serbia) have an important role in the implementation of cancer
screening programmes according to the official national programmes adopted by the Government.
They will be responsible for the local organisation and supervision of cancer screenings, including the
compilation of invitation lists, local co-ordination of health service providers, local mobilisation
interventions aimed at increasing the participation in screenings, supervision of performance and
quality of the services of local health care providers, data collection and analysis for the National
Cancer Screening Office on local capacities related to organised screenings, and supporting local
planning and development for screening programmes.

According to the National Breast Cancer Prevention Programme, organized breast cancer screening is
targeted to the age group of 45 to 69 years, and screening takes place every two years. The screening
programme is based on personal invitation for testing sent to all women in the target group, i.e.
invitation letter sent to home address. The invitation scheme will use the National Health Insurance
Fund register of insurees. Breast cancer screening events include clinical examination of breasts and
mammography, performed in two standard projections (mediolateral and craniocaudial). In line with
the standards set in the National Breast Cancer Prevention Programme, double reading is a must,
carried out by independent radiologists. The data actually available show approximately 1.300.000
women being in the target group (45-69 years), which means 650.000 women to be invited for
screening every year. Supposing 70% or less coverage in the first 5 years of the screening programme,
not more than 450.000 screenings per year will be preformed.


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Despite of the efforts aiming at developing technical background, supported by the European Union
IPA-programme, and also by the JICA (Japan International Cooperation Agency) bilateral co-
operation agreement, during the next several years the Serbian system of breast screening will remain
heterogeneous as regards technical infrastructure. It means that screen-film mammography and digital
mammography (computed radiography or full-field digital mammography) will be present in the same
time in different locations, thus the radiologists shall be well versed in reading images of different
techniques. System development efforts aspire to assure the highest possible number of pictures to be
digitalized, and also to provide the optimal image reading facilities for the breast cancer screening
system. At least 3 full-field digital mammography units and 33 analogous mammography units with
computed radiography units will be set to work in the locations with the highest expected yearly
workload, but in some locations screen-film mammography will still be used as the only screening
modality.

In order to improve the image viewing conditions, screening mammogram reading will be
concentrated to 18-20 centres equipped with digital mammography units or with high-quality
diagnostic workstations with 5 megapixel monitors, according to the actual plans. These centres shall
have sufficient professional capacity as regards the number and skills of radiologists, and will also be
located in the country to provide opportunity to satellite mammography units/screening stations to
transfer their pictures for reading easily.

At present one of the most important obstacles of organized breast cancer screening in the Republic of
Serbia is the shortage of radiologists with necessary skills in screening mammogram reading. Data
from the National Breast Cancer Prevention Programme show that 580 radiology specialists work in
healthcare institutions, out of which less than 10% (50-60 radiologists) perform mammographic
diagnostics. In order to assure the high quality of reading, together with the optimal workload of
radiology specialists involved into the national breast cancer screening programme, the number of
radiologists with adequate skills in mammography diagnostics shall be doubled by the time the
national programme is launched, and also the systematic mammography diagnostics training of
radiologists has to be strengthened within the frame of existing continuous professional
development/continuous medical education (CPD/CME) programmes.

To produce high quality mammograms is a key success factor of the early diagnosis of breast cancer.
The radiographers, therefore, have a central role in the national breast screening programme. Currently
755 radiology technicians with higher education (radiographers) and 712 X-ray technicians with
secondary vocational training (radiology assistants) are working in the health care system of the
Republic of Serbia, but only a few of them have the necessary skills in screening mammography. At a
70% coverage of breast cancer screening programme (which is probably an overestimated proportion
at the beginning of the national programme) at least 70-80 well-trained radiographers shall be involved
into the screening programme with full-time capacity. Their training is a prerequisite of the success of
the national programme. In the long run the replacement of retiring staff shall be ensured. This
requires a continuous education scheme for mammography radiographers in place and built into the
national framework of health care staff continuous professional development (CPD/CME)
programmes.

According to the National Cervical Cancer Prevention Programme, organized cervical cancer
screening is targeted to the age group of 25 to 69 years, and screening takes place every three years.
The screening programme is based on personal invitation for testing sent to all women in the target
group, i.e. invitation letter sent to home address. The invitation scheme will use the population
register. The cervical cancer screening events are limited to cervical smear checking (Papanicolaou
test). The screening interval is three years.




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Cervical smear is taken at the primary health care centres (dom zdravlja in Serbian health care
organisation) by gynaecologists1. After fixation the smears are processed in cytology laboratories,
however the existing practice in the country shows remarkable heterogeneity. In most cases the
staining of the smears takes place at the level of primary health care, and the reading is performed by
the gynaecologist himself. This did not allow high-quality reading practice to evolve, so thus smear
reading is not carried out by trained and skilled cytotechnicians, but medical specialists, who perform
this task by their other daily activities and have a low annual number of readings (1000-2000/year).
Also this practice does not fit in the standards set by international recommendations and guidelines.

The data actually available show approximately 2.270.000 women being in the target group (25-69
years), which means 760.000 women to be invited for screening every year. Supposing 50% or less
coverage in the first 5 years of the screening programme, not more than 380.000 cervical cancer
screenings per year will be preformed.

At present one of the important obstacles of organized cervical cancer screening in the Republic of
Serbia is the shortage of cytotechnicians and cytopathologists with necessary skills in evaluating Pap
smears.

Data from the National Cervical Cancer Prevention Programme show that approx. 130 pathology
specialists work in Serbia, out of which only several have sub-specialisation in cytopathology. In order
to provide the necessary professional supervision of smear reading, the number of pathologists with
adequate skills in cytopathology diagnostics shall be doubled by the time the national programme is
launched. The cytopathology training of pathologists has to be strengthened within the frame of
existing continuous professional development/continuous medical education (CPD/CME)
programmes. There are two established cytopathologist sub-specialisation programmes: at the Medical
Faculty of the University of Novi Sad, and at the Medical Faculty, University of Beograd available for
those with specialisation in pathology.

In cervical cancer screening the main task of cytotechnologists is the primary screening of cervical
smears of women without specific symptoms. This requires specific knowledge and skills, and also a
continuous, adequate workload, effective quality assurance mechanisms, mutual control of work
among cytotechnicians, and professional supervision by cytopathologist. For several reasons (lack of
cytopathology as an established sub-discipline, still existing tradition of alternative organisation of
smear reading) there is a severe shortage of trained cytotechnicians (in Serbia they are called:
cytoscreeners). In order to assure high quality Papanicolaou smear reading in the national cervical
cancer screening programme, together with assuring optimal workload of cytotechnicians involved
into the national cervical cancer screening programme, the number of trained cytotechnicians should
be increased considerably. Furthermore, the laboratory technicians must have the opportunity to
educate themselves in the field of cytology, the cytotechnicians training shall be built into the
CME/CPD system for professionals with non-medical degree (nurses, other relevant paramedical
professionals).

According to the National Programme for Colorectal Cancer Prevention, organized colorectal cancer
screening is targeted to the age group of 50 to 69 years. The invitation scheme will use the National
Health Insurance Fund register of insurees. The screening takes place every year. The screening
programme is based on personal invitation for testing sent to all people in the target group, i.e.
invitation letter sent to home address, together with an information leaflet, a short questionnaire on
colorectal malignancy risk factors, and faecal occult bleeding tests, now it is the faecal
immunochemical test. The patient receives also an envelope to send back the test to the local
1
  The gynaecology in the Serbian health care is organised into a two-tier system. A considerable proportion of
gynaecologists (more than 500 gynaecologists, according to data from 2005) are working in primary health care,
and more than 650 works in higher levels (secondary or tertiary) of the health care system. Majority of women in
Serbia is registered to one of the 500 gynaecologists working in primary health care.

                                                      11
laboratory. To increase the participation, the primary health care staff is involved into the mobilisation
of patients, to inform and motivate people by their general practitioner they are registered to.

The data from 2006 show approximately 1.900.000 people being in the target group (50-69 years), to
be invited for screening every year. Supposing not more than 50% participation rate in the first years
of the screening programme, and assuming about 3.6% positives for faecal occult bleeding (the pilots
in Voždovac, Beograd had the positivity rate of 3,6%) not more than successive 35.000 colonoscopies
are expected to be performed.

At present one of the most important obstacles of organized colorectal cancer screening in the
Republic of Serbia is the shortage of gastroenterologists with the necessary skills in performing
colonoscopy, especially in patients presenting only positive for faecal occult bleeding, but without
symptoms.

The Serbian Gastroenterology Association and Serbian Society for Gastrointestinal Endoscopy and
Society of Coloproctology state that short courses „„should not be considered a substitute for training
acquired during a formal residency/fellowship in an accredited training program‟‟; however, the ability
to practice therapeutic techniques on endoscopic simulators without associated risks to the patient
early on in training would be advantageous. The European Society of Gastrointestinal Endoscopy has
recommended that simulators, where available, should be used for training in GI endoscopy.

The key national policy documents related to colorectal cancer screening are the National Program
“Serbia Against Cancer” and the National Programme for Colorectal Cancer Prevention. These
documents could be downloaded from the website of the Ministry of Health at:
http://www.minzdravlja.info/downloads/Zakoni/Strategije/Nacionalni%20Program%20Za%20Prevenc
iju%20Kolorektalnog%20Karcinoma.pdf.

When the trainings and sustainable training programmes are planned, the national legislation on
continuous medical education shall be taken into account, according to the Rule Book on Closer
Conditions for Implementing Continuous Education for Health Workers and Healthcare Collaborators
(“Official Gazette of the RS”, number 130/07).

Lessons learnt from previous pilot projects on organised cancer screenings show that social
mobilisation campaigns, outreach techniques can effectively increase the willingness of participation
in cancer screening among the population. Careful planning, selection of adequate methods, thorough
monitoring of the implementation of social mobilisation campaigns could make them an effective tool
to serve organised cancer screening programmes.

One of the mobilisation techniques with proven effectiveness is the involvement of primary health
care staff, to use their potential in advising, informing people on health-related issues.

Beside this, local campaigns, distribution of information material, local media appearance could be a
useful accompanying communication intervention to national media campaigns.

It will be the task of the district public health institutes‟ staff to deliver short training programmes for
the health care staff – general practitioners, practice nurses, gynaecologists – of local primary health
care centres (dom zdravlja). These short trainings will focus on the duties of concerned staff related to
cancer screening, with special regard to patient information and mobilisation, professional
communication, and role of primary health care in colorectal cancer screening, i.e. performing faecal
occult blood testing.

The key national policy documents related to the cancer screenings are the National Program “Serbia
Against Cancer” and the National Breast Cancer Prevention Programme, the National Programme for
Cervical Cancer Prevention and the National Programme for Prevention of Colorectal Carcinoma to be

                                                    12
downloaded       from        the     website       of      the           Ministry       of       Health
(http://www.minzdravlja.info/downloads/Zakoni/Strategije).

When the trainings and sustainable training programmes are planned, the national legislation on
continuous medical education shall be taken into account, according to the Rule Book on Closer
Conditions for Implementing Continuous Education for Health Workers and Healthcare Collaborators
(“Official Gazette of the RS”, number 130/07).

             4.1.2.   Geographical area to be covered

Republic of Serbia under the authority of the Government of the Republic of Serbia

             4.1.3.   Target groups

Ministry of Health staff, staff of National Cancer Screening Office, staff of health institutions
participating in the implementation of organized cancer screening programmes, and the public health
institute network staff.

     4.2.    Specific activities

             4.2.1.   Project component 1 Strengthening public health capacities

In order to assist effectively the public health capacity development of cancer screening programme
implementation in the Republic of Serbia, the Consultant shall carry out the following tasks, in order
to achieve the expected results.

To Result 1. of Project Component 1. “established, operational and competent National Cancer
Screening Office, working according to international public health standards”

             4.2.1.1. Employing National Cancer Screening Office staff and operating NCSO

The NCSO staffs is estimated to 5 experts: 1 executive manager, 3 professional associates, each
working as coordinator for national cancer screening programmes (breast, cervical and colorectal) and
1 IT expert responsible for the national cancer screening database operation.

The Consultant will employ the NCSO staff for 2,5 years, and operate the NCSO according to the
rules and regulations set by the Ministry of Health, and the internal procedures and standards to be
worked out by the NCSO staff. The Ministry of Health shall take the necessary legal measures to
provide the legal framework for the operation on NCSO, including the amendment of structure of
Institute of Public Health (IPH) of Serbia “Dr Milan Jovanović Batut”, establishing authorities for
NCSO concerning data collection and analysis, performance monitoring and quality assurance; this in
collaboration with the National Agency for Accreditation and Continuous Improvement of Quality of
Health Care.

The NCSO staff will have the task to create and maintain professional contacts with the relevant
national institutes of Serbia, and organise its activities according to the legal framework and by the
guidance provided by the NCSO Advisory Board consisting of prominent clinical professionals,
representative of public health sciences and the Ministry of Health and the National Health Insurance
Fund. The professional networking includes at least 1 workshop on each cancer screening programme,
with the key stakeholders and leading professionals.

The legal and financial administrative capacity, and furthermore the internal professional capacities of
the Institute of Public Health (IPH) of Serbia “Dr Milan Jovanović Batut” are provided for the NCSO
successful operation.

                                                  13
To Result 1. of Project Component 1. “established, operational and competent National Cancer
Screening Office, working according to international public health standards”

             4.2.1.2. Training and skill development of National Cancer Screening Office professional
                      associates (breast, cervical and colorectal cancer screening coordinators)

The national cancer screening coordinators need a professional training on the operation of cancer
screening systems and, especially data collection and reporting on cancer screening and related
subjects (e.g. capacity assessment). Furthermore, they will need organisational development and
networking skills, knowledge and skills on quality assurance and performance monitoring. The
knowledge of mobilization techniques is vital for the co-ordinators, also the professional networking
and communication techniques.



To Result 1. of Project Component 1. “established, operational and competent National Cancer
Screening Office, working according to international public health standards”

To Result 3. of Project Component 1.”cost calculations in relation to cancer screening programmes,
based on available epidemiological and clinical data, and assessment of health gain from cancer
screening programmes at different participation rates”

             4.2.1.3. Working out and implementing NCSO data collection procedures and reports

The Consultant will make a proposal concerning the data content of reports prepared by the NCSO.
Report on national screening system, regular survey of available capacities (human resource and
infrastructure), performance of health services providers related to cancer screenings shall be included.
The NCSO collect information from the health care providers directly (e.g. screening events and
results), and with the help of district public health institutes (capacities, performance).



To Result 1. of Project Component 1. “established, operational and competent National Cancer
Screening Office, working according to international public health standards”

             4.2.1.4. Defining and supervision of development of NCSO Database Software solution

The national cancer screening database shall contain all relevant records concerning organised
screening programmes. These are: population lists by unique ID number, list of people (by unique ID
number) invited for screening, date and site of appearance, result of screening (negative or non-
negative) by screening type. The legal regulation of the Republic of Serbia makes it possible to use
personal health insurance identification number for identification purposes in the cancer screening
systems, and also it is already used in the National Cancer Registry. This gives the opportunity to
create cross-tables using the cancer screening database and cancer registry.

The database software is independent of the National Cancer Registry software but has to be
compatible with it. The NCSO cancer screening database software solution shall be based on previous
health care related software development projects, but operated independently from those.

The estimated annual data input is about 1-3 million records per year (breast, cervical and colorectal
cancer screening, supposing 100% coverage). One record has at least 5-10 fields, depending on the
type of screening. The screening takes place every two years in case of breast cancer and colorectal
cancer screening, and in three years in case of cervical cancer screening.
                                                   14
The content of reports generated shall be in line with the relevant international standards e.g. European
Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis and European Guidelines
for Quality Assurance in Cervical Screening.



To Result 2. of Project Component 1. “50 district public health institutes experts trained in cancer
screening related basic epidemiology, principles of screening, methods of organisation, data
collection, performance monitoring and evaluation, and local mobilisation techniques”

             4.2.1.5. Training district public health institutes staff on organised cancer screenings

The district public health institutes staff will be the local co-ordinators of the cancer screening
programmes. Their capacities should be strengthened in the field of:

       local co-ordination,

       using social mobilisation techniques, especially reaching the poor and marginalised groups,

       data collection and analysis;

       performance monitoring;

The trainings are aimed at local public health staff members, who will be directly involved into the
operation of cancer screening programmes. The training is a short training course, 1-2 days, involving
approx. 40-45 public health experts from district public health institutes.



             4.2.2.   Project component 2 Strengthening human resources for cancer screenings



To Result 1. of Project component 2. “a comprehensive training course material compiled to train
radiologists on breast cancer screening and diagnostics in accordance with the recommendations and
standards set by the European practices and guidelines, and 80 radiologists trained according to
European standards in breast cancer screening and diagnostics” and

To Result 2. of Project component 2. “training on breast cancer screening and diagnostics is built
into the continuous medical education system for radiologists and for radiographers, according to the
existing legal regulation in the Republic of Serbia”

             4.2.2.1. Compilation of training programme for radiologists

Based on the relevant sections of “European guidelines for quality assurance in breast cancer
screening and diagnosis, 4th edition, 2006, Guidelines for training” (European Breast Cancer Network
Coordination Office, International Agency for Research on Cancer) and also based on the “Guidelines
on the standards for the training of specialised health professionals dealing with breast cancer”
(European Society of Mastology (EUSOMA), as published in the European Journal of Cancer, 43,
(2007) 660-675, a comprehensive training course shall be worked out. The theoretical and practical
content of the training programme should be in line with the relevant items of the abovementioned
documents.
The training programme includes a 3–4 days residential course, which would cover the training
subjects, with practical film reading sessions and mammography test reading, a 3 weeks secondment at
a specialist breast diagnostic unit, with direct involvement in the clinical work co-ordinated by a
                                                   15
responsible tutor. Also includes 6 months activity at the base unit, with interaction and help from the
tutor, and a 1–2 days secondment at the tutor‟s breast unit in order for the tutor to assess the impact of
training on the radiologist‟s performance.
The Consultant will prepare, within this sub-task (all documents in Serbian and English language):

       curriculum for the training course;

       teaching material, in form of lecture notes;

       hand-outs for lectures;

       guide for tutors;

       set of films/pictures for reading sessions and test readings;

       chrestomathy including the most important sections of the relevant international documents.

When training is planned, the national legislation on continuous medical education shall be taken into
account, according to the Rule Book on Closer Conditions for Implementing Continuous Education for
Health Workers and Healthcare Collaborators (“Official Gazette of the RS”, number 130/07).

The documents (i.e. curriculum, teaching material etc.) prepared by the Consultant will be transferred
for further utilisation to appointed organisation(s) – by the decision of the Ministry of Health of the
Republic of Serbia – when the Consultant‟s tasks will have been completed.



To Result 1. of Project component 2. “a comprehensive training course material compiled to train
radiologists on breast cancer screening and diagnostics in accordance with the recommendations and
standards set by the European practices and guidelines, and 80 radiologists trained according to
European standards in breast cancer screening and diagnostics”

              4.2.2.2. Delivery of training programme for radiologists

Based on the training programme compiled, the Consultant shall organize the training programme for
radiologists in order to provide the necessary skills, proficiency to read screening mammography
pictures in the national breast screening system of the Republic of Serbia.

The training programme for radiologists shall be made available to approx. 80 radiologists – divided
into smaller groups – working in almost all districts of the country. The accommodation and meals for
participants during the residential course and the closing short secondment shall be paid from the
budget of the project.

The location of the residential course will be decided upon by the Consultant.

The tutorial component and the closing short secondment of the training programme may take place at
4 dedicated clinical centres in Serbia, namely Novi Sad – Institute of Oncology Sremska Kamenica,
Beograd – National Institute of Oncology and Radiology, Kragujevac – Clinical Centre, Niš – Clinical
Centre.




                                                    16
To Result 3. of Project component 3. “a comprehensive training course material compiled to train
radiographers on breast cancer screening and diagnostics in accordance with the recommendations
and standards set by the best European practices and guidelines, and 100 radiographers trained
according to European standards in breast cancer screening and diagnostics” and

To Result 2. of Project component 2. “training on breast cancer screening and diagnostics is built
into the continuous medical education system for radiologists and for radiographers, according to the
existing legal regulation in the Republic of Serbia”

             4.2.2.3. Compilation of a training programme for radiographers

Based on the relevant sections of “European guidelines for quality assurance in breast cancer
screening and diagnosis, 4th edition, 2006, Guidelines for training” (European Breast Cancer Network
Coordination Office, International Agency for Research on Cancer) and also based on the “Guidelines
on the standards for the training of specialised health professionals dealing with breast cancer”
(European Society of Mastology (EUSOMA), as published in the European Journal of Cancer, 43,
(2007) 660-675, a comprehensive training course shall be worked out. The theoretical and practical
content of the radiographers training programme shall be in line with the relevant items of the
abovementioned documents.

The training programme includes at least 40 hours of documented training specific to the radiographic
aspects of mammography practical training, and also practical training what requires a 1:1
student/trainer ratio, and the trainees should perform at least 75 mammograms under the supervision
of trainers.

The Consultant will prepare:

       curriculum for the training course;

       teaching material, in form of lecture notes;

       hand-outs for lectures;

       guide for practical trainers.

When training is planned, the national legislation on continuous medical education shall be taken into
account, according to the Rule Book on Closer Conditions for Implementing Continuous Education for
Health Workers and Healthcare Collaborators (“Official Gazette of the RS”, number 130/07).

By decision of the Ministry of Health of the Republic of Serbia, the documents (i.e. curriculum,
teaching material etc.) prepared by the Consultant will be transferred to appointed organisation(s) for
further utilisation after the tasks will have been completed.



To Result 3. of Project component 3. “a comprehensive training course material compiled to train
radiographers on breast cancer screening and diagnostics in accordance with the recommendations
and standards set by the best European practices and guidelines, and 100 radiographers trained
according to European standards in breast cancer screening and diagnostics”

             4.2.2.4. Delivery of training programme for radiographers

Based on the training programme compiled, the Consultant shall organize the training programme for
radiographers in order to provide the necessary skills, proficiency in breast cancer screening

                                                   17
technology, incl. taking screen-film mammography and digital mammography (computed radiography
or full-field digital mammography) pictures, and using these equipments.

The training programme for radiographers shall be made available to approx.100 radiographers –
divided into smaller groups – working in almost all districts of the country. The accommodation and
meals for participants during the initial residential course is to be paid from the budget of the project.

The Consultant will decide on the locations for the residential courses, optimally in several locations
in the country, with practice components in centres with the highest turn-over of screening
mammography.



To Result 4. of Project component 2. “a comprehensive training course material compiled to train
cytopathologists on cervical cancer screening and diagnostics in accordance with the
recommendations and standards set by the European practices and guidelines, 30 pathologists trained
according to European standards in cervical cancer screening and diagnostics” and

To Result 5. of Project component 2. “training on cervical cancer screening and diagnostics is built
into the continuous medical education system for pathologists and laboratory assistants, according to
the existing legal regulation in the Republic of Serbia”

              4.2.2.5. Organisation and delivery of training programme for cytopathologists

Based on the relevant sections of “European guidelines for quality assurance in cervical cancer
screening, 2nd edition, 2008, (International Agency for Research on Cancer) and also based on the
already existing cytopathology sub-specialisation training programme in Serbia, a comprehensive
training course shall be delivered to pathologists to enable them to carry out tasks related to
administration and professional supervision of cytopathology laboratories. The theoretical and
practical content of the training programme should be in line with the relevant items of the
abovementioned documents.
The Consultant within this sub-task (all documents in Serbian and English language) shall:

       identify existing cyto-pathology training programmes in the country;

       in co-operation with the identified university(ies) shall develop a training course, which:

            o is based on the existing, and already accredited cytopathology course programmes;

            o allows the participants to obtain the knowledge and skills necessary to administer and
              supervise cytopathology laboratories in relation to cervical cancer screening
              programme, within 6 months;

            o allows the participants to complete their cytopathology sub-specialisation in the
              following time without interrupting their studies or practical trainings.

When training is planned, the national legislation on continuous medical education shall be taken into
account, according to the Rule Book on Closer Conditions for Implementing Continuous Education for
Health Workers and Healthcare Collaborators (“Official Gazette of the RS”, number 130/07).

The training programme for pathologists shall be made available to approx. 30 pathologists working in
different districts of the country.



                                                   18
To Result 6. of Project component 2. “a comprehensive training course material compiled to train
cytotechnicians on cervical cancer screening and diagnostics in accordance with the
recommendations and standards set by the best European practices and guidelines, and 100
cytotechnicians trained according to European standards in cervical cancer screening and
diagnostics” and

To Result 5. of Project component 2. “training on cervical cancer screening and diagnostics is built
into the continuous medical education system for pathologists and laboratory assistants, according to
the existing legal regulation in the Republic of Serbia”

             4.2.2.6. Compilation of a training programme for cytotechnicians

Based on the relevant sections of “European guidelines for quality assurance in cervical cancer
screening, 2nd edition, 2008, (International Agency for Research on Cancer) and also taking into
account the standards set forth in the “National Program for Cervical Cancer Prevention” a
comprehensive training course shall be worked out. The theoretical and practical content of the
cytotechnologist training programme has to be in line with the relevant sections of the
abovementioned documents. The training course shall allow the trainees to take part also in the regular
work of their base cytopathology laboratory.

The Consultant will prepare:

       curriculum for the training course;

       teaching material, in form of lecture notes;

       hand-outs for lectures;

       guide for practical training.

When training is planned, the national legislation on continuous medical education shall be taken into
account, according to the Rule Book on Closer Conditions for Implementing Continuous Education for
Health Workers and Healthcare Collaborators (“Official Gazette of the RS”, number 130/07).

By decision of the Ministry of Health of the Republic of Serbia, the documents (i.e. curriculum,
teaching material etc.) prepared by the Consultant will be transferred to appointed organisation(s) for
further utilisation after the tasks will have been completed.



To Result 6. of Project component 2. “a comprehensive training course material compiled to train
cytotechnicians on cervical cancer screening and diagnostics in accordance with the
recommendations and standards set by the best European practices and guidelines, and 100
cytotechnicians trained according to European standards in cervical cancer screening and
diagnostics”

             4.2.2.7. Delivery of training programme for cytotechnicians

Based on the training programme compiled, the Consultant shall organize the training programme for
cytotechnicians in order to provide the necessary skills, proficiency in cervical cancer screening incl.
reading cervical smears, operating internal and external quality assurance methods in cytopathology
etc.

                                                   19
The training programme for cytotechnicians shall be made available to approx.100 laboratory
assistants, biologists, nurses with diploma – divided into smaller groups – working in almost all
districts of the country.

The Consultant will decide on the locations for the residential courses, optimally in several locations
in the country, with practice components in centres with the highest turn-over of screening cytology.
The accommodation and meals for participants during the residential courses is to be paid from the
budget of the project.



To Result 7. of Project component 2. “a comprehensive practice course material compiled to train
gastroenterologists to perform colonoscopy in accordance with the recommendations and standards
set by the international practices and guidelines, 50 gastroenterologists trained according to
international standards in colonoscopy – especially in colorectal cancer diagnostics and therapeutic
interventions (polypectomy)” and

To Result 8. of Project component 2. “training on colonoscopy is built into the continuous medical
education system for gastroenterologists, according to the existing legal regulation in the Republic of
Serbia”

             4.2.2.8. Organisation and delivery of training programme for gastroenterologists

Based on the best international practices and professional requirements needed for performing
colonoscopy, and, also using the colonoscopy training simulator located in the gastroenterology
department of the Clinical Centre of Serbia, Beograd, at least 50 gastroenterologists should be trained
on performing colonoscopy (polypectomy interventions included). The training course shall last 6
months and the trainees should be able upon completion of the course and following hands-on training
on patients to perform colonoscopy with 80-90% technical success before deemed competent in a
specific skill (e.g. ability to reach coecum over 80% of the time and have minimum of 50 supervised
interventions-polypectomies). The sites of hands on clinical training are the Clinical Centre of Serbia,
Belgrade, and the Clinical Centre of Vojvodina, Novi Sad. The trainers‟ remuneration is paid out of
the project budget. The Consultant:

       prepares the detailed training plan;
       prepares guide for tutors for clinical practice;
       carries out and provides supervision for colonoscopies carried out using the simulator;
       organises the clinical practice for trainees, assuring the professional supervision and a tutorial
        guidance during training period.

To Result 7. of Project component 2. “a comprehensive practice course material compiled to train
gastroenterologists and surgeons to perform colonoscopy in accordance with the recommendations
and standards set by the international practices and guidelines, 50 gastroenterologists trained
according to international standards in colonoscopy – especially in colorectal cancer diagnostics and
therapeutic interventions (polypectomy)”

             4.2.2.9. Organisation and delivery of training programme for colonoscopy assistants

Based on the best international practices and professional requirements a one-day short training course
shall organised and delivered in 5 locations in Serbia for colonoscopy assistants on colorectal
screening, preparation of patients, appropriate instrument and accessories maintenance. Expected
number of assistants to be trained is 70-80.



                                                   20
             4.2.3.   Project component 3 Assisting Ministry of Health in awareness raising and
                      mobilisation campaign



To Result 1. of Project component 3. “teaching/educational material for short training – in 4-6 hours
– prepared for district public health institutes staff in order to train and educate selected primary
health care staff (dom zdravlja administrative staff, general practitioners and practice nurses) on
tasks and techniques of effective participation in cancer screening programmes, with special regard to
colorectal cancer screening, and on mobilisation their patients for screening”

             4.2.3.1. Preparing short training programme and professional information materials for
                      primary health care staff on cancer screenings

The Consultant (and the Cancer Screening Office) shall support the local knowledge and skills transfer
activity of district public health institutes staff, by providing the following:

       compilation of a short training programme (4-6 hours) to be applied by district public health
        institutes staff, in order to transfer information and knowledge to local primary health care
        staff on their role in cancer screenings, especially in organised colorectal cancer screening,
        and on effective mobilisation of patients to participate in cancer screening. The local public
        health institutes‟ staff (“train the trainer” approach) will be prepared to train local primary
        health care staff on screenings as a cost-effective method of multiplying knowledge in primary
        care. The documentation of short training course includes:

            o hand-outs for lectures;

            o guide for trainers;

            o short, easy-to-use information material for local primary health care staff training, 3-4
              pages altogether, in 30.000 copies.



To Result 1. of Project component 3. “teaching/educational material for short training – in 4-6 hours
– prepared for district public health institutes staff in order to train and educate selected primary
health care staff (dom zdravlja administrative staff, general practitioners and practice nurses) on
tasks and techniques of effective participation in cancer screening programmes, with special regard to
colorectal cancer screening, and on mobilisation their patients for screening”

To Result 2. of Project component 3. “district public health institutes staff trained and supplied with
teaching/educational material on educating selected primary health care staff on participation in
cancer screening programmes, with special regard to colorectal screening, and on mobilisation
patients for screening”

             4.2.3.2. Training of district public health institutes staff to educate primary health care
                      staff on cancer screenings

District public health institutes staff shall trained and supplied with teaching/educational material on
educating selected primary health care staff on participation in cancer screening programmes, with
special regard to colorectal screening, and on mobilisation patients for screening. Using local public
health capacities to disseminate information to primary health care staff can be a low-cost and still
effective technique, if carried out appropriately and local trainers are prepared for this task.


                                                  21
To Result 3. of Project component 3. “assistance provided for the Ministry of Health to the
mobilisation campaign in the form of printed information leaflet for patients, short information leaflets
for primary health care staff”

             4.2.3.3. Assisting the Ministry of Health to its mobilisation campaign in the form of printed
                      information leaflet for patients, short information leaflets for primary health care
                      staff

The Consultant, in agreement and close co-operation with the Ministry of Health, shall support
national-level media campaigns organised and financed by the Ministry, with printed materials on
cancer screenings to be distributed in dom zdravljas and at local events organised by local public
health institutes. The total amount of media activity, printing, design work shall not exceed the
230.000 EUR, and could be considered as a supplementary activity to the Ministry‟s efforts. The
accurate date and sequence of launching national cancer screening programmes have not been decided
on yet, detailed planning of social communication activities could be planned only after the Ministry
of Health made the necessary decisions.


5. PROJECT MANAGEMENT
5.1. Responsible body

The Contracting Authority shall be the Delegation of the European Commission to the Republic of
Serbia and thus the Consultant is solely responsible to the EC Delegation on all matters pertaining to
the Contract and its Terms and Conditions.

5.2. Management structure

A project Steering Committee (SC) shall be convened during the inception phase. The SC will steer
and monitor project implementation and undertake remedial actions for problems that may arise.
Membership will include at least:
    -   The Minister of Health or an appointed MoH representative (Chair);
    -   EC Delegation Project Manager;
    -   Project Team Leader (Convenor and Secretary);
    -   The representative of the National Health Insurance Fund (as member of the National Cancer
        screening Office Advisory Board);
    -   Health Professional Members of the National Cancer Screening Office Advisory Board (for
        breast, cervical and colorectal screening)
    -   The Director of the National Institute of Public Health;
    -   Other representatives as required.
Representatives from additional beneficiary institutions may be included as observers. Other
representatives of the project team or the health sector in Serbia may attend on an ad hoc basis at the
invitation of the SC. The project will provide secretarial support to the Steering committee.
The SC will meet every three months at the least. It shall maintain a continuing focus on project
results; provide continuing guidance on policy and technical matters relating to all project components
and continuous advice on the allocation and prioritisation of project resources. The Steering
Committee shall receive the executive summaries of project reports as prepared by the project team
and approved by the EC Delegation Project Manager.
The implementation of the Project will be coordinated with the national coordination body(s) and the
contact person appointed by the Ministry of Health, through regular meetings.

The Project Manager at the EC Delegation is responsible for approving periodical narrative reports,
approving inclusion of non-key experts and the use of funds from the incidental expenditure as well as
                                                   22
approving and preparing any modifications to the original contract and annexes, approval of financial
reports and payment execution.

6. LOGISTICS AND TIMING
     6.1.    Location

The location of the project office is Beograd, the Republic of Serbia. Trainings and other education
programmes may take place in other locations as indicated in the relevant parts of the ToR.

     6.2.    Commencement date & Period of implementation

The intended commencement date is January 2011 and the period of implementation of the contract
will be 24 months from this date. Please refer to Articles 4 and 5 of the Special Conditions for the
actual commencement date and period of implementation.



7. REQUIREMENTS
     7.1.    Personnel

             7.1.1.   Key experts

All experts who have a crucial role in implementing the contract are referred to as key experts. They
are expected to perform all project related activities in Serbia and any relevant study tours organised
by the project abroad. Therefore, the key experts are expected to spend at least 85% of their time in
Serbia.

                                                                                   Number of days
Experts                                                      Number of experts
                                                                                    (minimum)
Key experts
LT Public Health – Team Leader                                        1                  400
LT Breast Cancer Screening Expert                                     1                  100
LT Cervical Cancer Screening Expert                                   1                  100
LT Colorectal Cancer Screening Expert                                 1                  100
Non-key experts
Senior experts                                                      Pool                 500
Junior LT experts – national cancer screening co-
                                                                      3                  1260
ordinators (breast, cervical and colorectal)
Junior LT expert (IT expert)                                        1                   240
                                                              A minimum of 2,000 days must be
Total number of person days
                                                              foreseen for the non-key experts.


All key experts are required to have an excellent command of the English language, including oral and
written reporting abilities, as well as strong managerial and negotiation skills, preferably at
government level.




                                                  23
The profiles of the key experts for this contract are as follows:

Key expert 1: Team Leader

Qualifications and skills

           Educations: A senior expert with a relevant university degree, or equivalent (where a
        university degree has been awarded on completion of a minimum of four years study in a
        university or equivalent institution) in the field of Medical sciences, or Degree in Health
        Sciences, Health Economics. A Master‟s Degree in a health related field is required, PhD or
        MBA (health services) would be an asset.

       Professional skills:

            o skills in working with multi-national and multi-disciplinary teams,

            o skills in project planning and implementation;

            o skills in working with state administration, in transition countries is an asset;

       Team management skills: leadership skills, necessity to manage a self-developing team with
        multi-faceted activities;

       Communication skills: Communication skills in team management and operation are required.
        Skills in communication with medical professionals, especially with leading professionals in
        medical disciplines are an advantage.

       Language skills: Fluency in English (written and spoken)

General professional experience

       at least 10 years working experience in public health or health care sector

       3 years managerial experience in the field of public health or health care

       experience obtained in transition countries on public health or health care is an advantage

Specific professional experience

       Proven experience in organisational development in the health sector (incl. public health) or
        public administration;

       Experience of cancer screening programme planning and implementation;

       Experience of performance monitoring of health care providers is a requirement.

       Organising and/or planning medical professional education programmes is an advantage;

       Experience of planning and building institutions in transition countries is an asset;



Key expert 2: Senior expert – Specialist in breast cancer screening


                                                    24
Qualifications and skills

       Educations: A senior expert with a relevant university degree, or equivalent (where a
        university degree has been awarded on completion of a minimum of four years study in a
        university or equivalent institution) in the field of Medical sciences, or Degree in Health
        Sciences, A Master or PhD is an asset.

       Skills in project planning and implementation are an advantage;

       Skills in supervising and coaching young professionals, especially in the field of health care or
        public health is an asset;

       Skills in drafting reports,

       Language skills: Fluency in English (written and spoken)

General professional experience

       5 years working experience in relation to breast cancer screening, or diagnostics/treatment;

       working experience in transition countries is an advantage;

Specific professional experience

       proven experience in working in breast cancer screening programme;

       specific knowledge of breast cancer epidemiology and national screening systems World-
        wide;

       designing and implementation of national or regional level breast cancer screening
        programmes is an asset;

       knowledge of data collection systems in the field of cancer screening or knowledge of
        operation of cancer registries is an advantage.

Key expert 3: Senior expert – Specialist in cervical cancer screening

Qualifications and skills

       Educations: A senior expert with a relevant university degree, or equivalent (where a
        university degree has been awarded on completion of a minimum of four years study in a
        university or equivalent institution) in the field of Medical sciences, or Degree in Health
        Sciences. A Master or PhD is an asset.

       Skills in project planning and implementation are an advantage;

       Skills in supervising and coaching young professionals, especially in the field of health care or
        public health is an asset;

       Skills in drafting reports,

       Language skills: Fluency in English (written and spoken)

General professional experience
                                                   25
       5 years working experience in relation to cervical cancer screening, or diagnostics/treatment;

       working experience in transition countries is an advantage;

Specific professional experience

       proven experience in working in cervical cancer screening programme;

       specific knowledge of cervical cancer epidemiology and national screening systems world-
        wide;

       designing and implementation of national or regional level cervical cancer screening
        programmes is an asset;

       knowledge of data collection systems in the field of cancer screening or knowledge of
        operation of cancer registries is an advantage.

Key expert 4: Senior expert – Specialist in colorectal cancer screening

Qualifications and skills

       Educations: A senior expert with a relevant university degree, or equivalent (where a
        university degree has been awarded on completion of a minimum of four years study in a
        university or equivalent institution) in the field of Medical sciences, or Degree in Health
        Sciences.. A Master or PhD is an asset.

       Skills in project planning and implementation are an advantage;

       Skills in supervising and coaching young professionals, especially in the field of health care or
        public health is an asset;

       Skills in drafting reports,

       Language skills: Fluency in English (written and spoken)

General professional experience

       5 years working experience in relation to colorectal cancer screening, or diagnostics/treatment;

       working experience in transition countries is an advantage;

Specific professional experience

       proven experience in working in colorectal cancer screening programme;

       specific knowledge of colorectal cancer epidemiology and national screening systems World-
        wide;

       designing and implementation of national or regional level colorectal cancer screening
        programmes is an asset;

       knowledge of data collection systems in the field of cancer screening or knowledge of
        operation of cancer registries is an advantage.

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             7.1.2.   Other experts

CVs for experts other than the key experts are not examined prior to the signature of the contract. They
should not be included in the tender offer. The Consultant shall select and hire other experts as
required according to the profiles determined in the Organisation and Methodology and these Terms of
Reference. All experts must be independent and free from conflict of interest in the responsibilities
accorded to them. The Consultant will ensure that a sufficient number of experts are fluent in Serbian.

The selection procedures used by the Consultant to select these other experts shall be transparent and
shall be based on pre-defined criteria, including professional qualifications, language skills and work
experience. The findings of selection panels shall be recorded. The selection of experts shall be subject
to approval by the contracting authority. Note that civil servants of the public administration of Serbia
regardless of their administrative situation cannot be recruited as experts.

Senior short-term experts will form a pool with the skills detailed below.

The team leader will report to the Project Manager of the EC Delegation in Belgrade. The project team
will ensure the technical compliance of the Project with best EU practices and will ensure coordination
with other ongoing projects and activities in the country.

The team leader will also ensure a close cooperation and partnership with the relevant European Union
agencies, European networks of professionals in the quality and accreditation, as well as prominent
international and non governmental organisations.

Junior long-term experts

The National Cancer Screening Office staff will consist of junior long-term experts, who will stay in
the NCSO after the termination of the Project. Optimally there is one expert dedicated to each national
cancer screening programmes as national co-ordinator (breast, cervical and colorectal), and an IT
expert to operate NCSO cancer screening database. The national co-ordinators (three junior long-term
experts) of the cancer screening programmes shall be selected by the Advisory Board of the National
Cancer Screening Office. The Advisory Board consists of professionals with high reputation,
appointed by the Minister of Health.

The estimated required capacity is 1.500 expert days altogether for the staff of NCSO for the whole
duration of the Project.

Senior short-term experts

A team of senior short-term experts shall be involved into the implementation of specific tasks related
to project implementation. They shall have an expertise in the field of professional education for
radiologist and radiographers, also for cytopathologists and cytotechnicians and in the field of
colonoscopy training. They will participate in the design and delivery of professional training
programmes for the selected health care professionals, and also as tutors for local professionals trained
in the Project. They must have a well-based international experience and/or local experience in
professional training in the field.

Furthermore, short-term senior experts will contribute to the planning and implementation of local
public health institutes training programmes, training of NCSO staff, epidemiological and cost-
calculations and planning and designing of health communication programmes. Therefore, experts
with the following skills shall be the part of the short-term senior experts‟ team: public health
expertise, mainly in the field of screening programmes, knowledge in practice and training of cancer
epidemiology, health economics, health communication practice and skills, experience in health
                                                   27
communication campaign (local experience is sufficient), and furthermore experience and skills in
organisational development in health care, optimally with special respect to cancer screening
programmes. A procurement expert with limited expert days capacity shall be included to support
procurement processes (short-term experts, educational materials etc.)

The short-term experts can be professionals with international practice and expertise, and also local
professionals. Their optimal combination could be the key to the successful implementation of the
tasks.

The total capacity devoted to short-term senior experts is altogether 500 expert days for the whole
duration of the Project.

              7.1.3.   Support staff & backstopping

Backstopping and support staff costs must be included in the fee rates of the experts.


     7.2.     Office accommodation

Office accommodation of a reasonable standard and of approximately 10 square metres for each expert
working on the contract is to be provided by the Beneficiary.

     7.3.     Facilities to be provided by the Consultant

The Consultant shall ensure that experts are adequately supported and equipped. In particular it shall
ensure that there is sufficient administrative, secretarial and interpreting provision to enable experts to
concentrate on their primary responsibilities. It must also transfer funds as necessary to support its
activities under the contract and to ensure that its employees are paid regularly and in a timely fashion.

If the Consultant is a consortium, the arrangements should allow for the maximum flexibility in
project implementation. Arrangements offering each consortium member a fixed percentage of the
work to be undertaken under the contract should be avoided.

     7.4.     Equipment

No equipment is to be purchased on behalf of the Contracting Authority / beneficiary country as part
of this service contract or transferred to the Contracting Authority / beneficiary country at the end of
this contract. Any equipment related to this contract which is to be acquired by the beneficiary country
must be purchased by means of a separate supply tender procedure.

     7.5.     Project Budget

The total budget available to implement the project is 2,100,000 Euro.

     7.6.     Incidental expenditure

The Provision for incidental expenditure is 550.000 EUR. It covers the ancillary and exceptional
eligible expenditure incurred under this contract. It cannot be used for costs which should be covered
by the Consultant as part of its fee rates, as defined above. Its use is governed by the provisions in the
General Conditions and the notes in Annex V of the contract. It covers:

    a) Preparation and distribution of training materials and information/visibility materials;

    b) information campaign costs;

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    c) costs directly related to trainings, e.g. accommodation and meals for trainees in residential
       components of the professional training programmes,

    d) costs directly related to workshops and conferences: venue rentals and meals for workshops
       and conference participants,.

    e) International travel and transport costs and subsistence allowances for missions/study tours to
       be undertaken as part of this contract requiring an overnight stay away from the base of
       operation in Serbia;
    f) Local travel and transport costs and subsistence allowances for missions requiring an
       overnight stay within Serbia;


The Consultant will need prior written approval from the Contracting Authority before
spending the funds related to components a), b), c), d) and e) within the Incidental Expenditure.
Any subsistence allowances to be paid for missions undertaken as part of this contract from the base of
operations in the beneficiary country must not exceed the per diem rates published on the Web site
http://europa.eu.int/comm/europeaid/index_en.htm at the start of each such mission.

This amount must be included without modification in the Budget breakdown.

     7.7.    Expenditure verification

The Provision for expenditure verification relates to the fees of the auditor who has been charged with
the expenditure verification of this contract in order to proceed with the payment of further pre-
financing instalments if any and/or interim payments if any.

The Provision for expenditure verification for this contract is EUR 80.000 for the whole duration of
the Project. This amount must be included without modification in the Budget breakdown.

     7.8.    Project visibility

The Consultant will receive the relevant guidelines from the EC Delegation. It is recommended that, at
the beginning of the project, a press conference be held and a press release be issued to national
professional journals, as well as to the regular press. Advantage should be taken of all appropriate
occasions to ensure coverage by the press and the media of events related to the project. All printed
material prepared by the Consultant, press releases, articles etc shall be cleared beforehand by the
Project Manager and the EC Delegation Press Officer, who shall also advise on the stickers,
letterheads, business cards etc used by the Consultant within the project. A detailed set of guidelines
applicable on project visibility are to be sought at the following web address:
http://www.ec.europa.eu/europeaid/work/visibility/index_en.htm .



8. REPORTS
     8.1.    Reporting requirements

An Inception Report is prepared after 3 months providing update of the local situation and a detailed
plan of implementation of the Project. Inception Report includes any clarifications of these Terms of
Reference that may be required to meet project objectives; list of major conceptual/strategic issues that
need to be resolved, with brief analysis of the issues and recommendations and other problems
encountered or envisaged, along with proposed solutions.

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Interim reports: Each report shall consist of a narrative section and a financial section. The narrative
section of reports shall be concise documents following each of the three project components (not
more than 20 pages per report, excluding progress charts and annexes).

The financial section of the reports must contain details of the time inputs of the experts, of the
incidental expenditure and of the provision for expenditure verification. They must be provided along
with the corresponding invoice, the financial report and an expenditure verification report defined in
Article 28 of the General Conditions. The progress report for a particular reporting period must be
submitted within 10 working days of the end of the reporting period.

A final report will be submitted not later than three weeks after the end of the project. The report shall
include the overall appraisal of the project including a financial analysis; indicate any deviations from
the initial plans and schedules as well as a critical study of any major problems that may have arisen
during the performance of the contract. The final report must detail the achievements of the project,
using the same structure, performance indicators and measurements as specified in the work plan. The
format of the final report shall be based on the standard EU reporting format (Annex A). The final
invoice, the financial report and an expenditure verification report must accompany the final report.

        8.2.   Submission & approval of progress reports

Three printed copies and one electronic version on CD-ROM of the progress reports referred to above
must be submitted to the Project Manager identified in the contract. The Project Manager is
responsible for approving the progress reports. The Ministry of Health of the Republic of Serbia has
the right to comment the reports.

All reports should be written in English, and submitted in hard copy and electronic form as follows:
                  Dr Maja Vuckovic-Krcmar, Health and Social Affairs Programme Manager
                  Delegation of the European Union to the Republic of Serbia
                  Vladimira Popovica 40, 5th floor
                  GTC Avenue block 19a
                  11070 New Belgrade
                  Serbia


9. MONITORING AND EVALUATION
        9.1.   Definition of indicators

         Internal rules and procedures of National Cancer Screening Office worked out;

         NCSO fully operating, according to approved Rules and Regulations;

         NCSO staff trained and competent to perform daily activity study visits organised;

         Detailed content and format of NCSO regular reports and policy documents worked out;
          reports are prepared in due time and format;

         Quality standards for performing screening programmes are established in accordance with
          EU quality assurance guidelines for all three types of cancer

         Cancer screening database developed in line with the European Network of Cancer of
          Registers (module in HIS and in primary health care information system) is operational by
          project completion.
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       Curricula and teaching material of health care professionals‟ training programmes;

       Number of trainings held for health care workers for early detection of cancer;

       Number of trainings held for local public health staff on cancer screenings;

       Number of health care workers educated to conduct cancer screenings during specific training
        programmes;

       Number of local public health staff trained in organising local screening programmes, and in
        training local primary health care staff;

       Number of individual invitations for screenings sent annually by local organisers (Dom
        Zdravljas);

       Number of professional information materials for primary health care professionals
        concerning participation in cancer screenings, number of printed copies of such materials;

       Number of leaflets, information materials designed and printed out for local distribution in
        population mobilisation campaigns.



      9.2.   Special requirements

N/A

                                                 ***




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