STANDARD TWINNING LIGHT PROJECT FICHE

Transcription

1 STANDARD TWINNING LIGHT PROJECT FICHE 1. Basic Information 1.1 Programme: IPA 2011 FF RAC 1.2 Twinning Number: HR/2011/IB/SO/02 TWL 1.3 Title: Contribution to institutional capacity for blood, tissue and cells in the implementation of the Directives 2002/98/EC and 2004/23/EC (CRO BTC) 1.4 Sector: Consumer and Health Protection 1.5 Beneficiary country: Republic of Croatia 2. Objectives 2.1 Overall objective: Increase of quality and safety of blood and availability, quality and safety of tissues and cells for human application in order to assure the highest possible level of public health protection. 2.2 Project purpose: Enhancement of capacity of the Competent Authority for Blood, Tissues and Cells with the purpose of assuring adequate and timely implementation of requirements within Directive 2002/98/EC and Directive 2004/23/EC in Blood, Tissues and Cells Establishments. 2.3 Contribution to Accession Treaty/Relevant national documents: Following the signature of the Accession Treaty on 9 December 2011 by 27 Member States (MS) and the Republic of Croatia and its ratification procedure, Croatia joined the European Union (EU) on 1 July Article 36 of the Accession Treaty states that Commission shall monitor all commitments undertaken by Croatia during the accession negotiation. Europe 2020 Strategy highlights the importance of providing possibility for the future generations to enjoy healthy life. One of the objectives of this strategy is to ensure better access to health care system which will reduce social exclusion and reduce health inequalities. National Health Care Strategy states that Croatia has timely harmonised national regulations with EU regulations in the area of health care sector in relation to blood, tissues and cells. Strategy focuses on many priorities, some of which are very relevant for this project: Preserving financial stability of health care and Strengthening and better use of human resources in health care. This Twinning light project will facilitate training and development of experts competences as well as development of institutional capacities and practices which will provide accessible and effective health care system for citizens. This project will also provide insight into the legislative framework of other countries and through examples of good practice for blood, tissues and cells, Croatian national legislation will be improved and Croatian professionals will benefit. 1

2 3. Description 3.1 Background and justification: Ministry of Health of the Republic of Croatia is the Competent Authority (CA) for Blood, Tissues and Cells, including reproductive tissues and cells for human application under Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells and Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC of the European Parliament and of the council on the Community code relating to medicinal products for human use. EU legislation regarding blood, tissues and cells and assisted reproduction technology (ART) has been transposed into the national legislative framework and adopted through three laws (Act on Blood and Blood Components OG 79/2006, Act on Human Tissues and Cells Application OG 144/12, Act on Medical Assisted Fertilization OG 86/12) and a number of ordinances determining the complete legal framework regarding blood, tissues and cells, and ART. Republic of Croatia has joined the EU on 1 July 2013, therefore Ministry of Health is aiming to ensure proper implementation of the requirements of the Directives into the Croatian health care system and to play a leading role in facilitating Blood, Tissue and Cells Establishments in fulfilling the requirements of the acquis. To achieve this goal Ministry of Health has to be able to perform all Competent Authority tasks in consonance within the requirements of competency stated in the Directives. Further to the admission of the new personnel within the Competent Authority's Service for Blood, Tissues and Cells Inspection, a plan for education was prepared. Inspectors have undergone basic professional trainings in regards to the quality assurance and inspection of Blood, Tissue and Cells Establishments (including ART) and implementation of other tasks within their stipulated competence. Specific inspectors trainings were conducted mainly under the EU projects: European Union Standards and Training in the Inspection of Tissue Establishments (EUSTITE), EU-Blood- Inspection Project (EuBIS), Competent Authority Training on Inspections in Europe (CATIE). Since those basic trainings covered theoretical knowledge of Directives purport and inspection procedures there is still a need for further education of Competent Authority staff in inspection practice. The main training needs refer to the necessity to observe on-site inspections of various establishments, conducted by experienced team of Member State(s). Professionals from the Cord Blood Bank and Competent Authority personnel will directly benefit from implementation of this Twinning light project by receiving training and education as well as support in proposing future projects in the field that will increase the overall efficiency and safety in blood, tissues and cells banking in the Republic of Croatia. Transfusion service Blood Transfusion Service (BTS) in Croatia is organized as public service. All Blood Establishments are inspected against requirements of the Act on Blood and Blood Components, and authorized. 2

3 Plan of Reorganization of Transfusion Service was implemented in the first half of 2013 according to the Instruction on Transfusion Service Reorganization Implementation, issued by the minister, which designs a stepwise approach and time-schedule for the Transfusion Service reorganization in Croatia. All phases of the reorganization of transfusion are completed; out of 9 blood establishments 5 perform serology testing and Croatian Institute for Transfusion Medicine (CITM) is the Nucleic Acid Testing (NAT) center. From 1 March 2013 the individual donor nucleic acid amplifying testing (ID NAT testing) of every blood donor dose for hepatitis B, hepatitis C and HIV viruses is introduced. The transport of donor blood samples is organized from other establishments to the CITM. The Republic of Croatia invested over 2 million euros in the period for equipping Blood Establishments. Costs for manufacturing blood products are paid from Croatian Health Insurance Fund equally to all Blood Establishments. Since Blood Establishments are financially and organisationally independent from each other, it is evident that product cost calculation does not take into account real expenses which differ from one to another Blood Establishment depending on suppliers, quantities, transportation costs, etc. With respect to the need to maintain the equal safety and quality of blood products manufactured in all Blood Establishments, costs of the blood products have become a burden to the health budget. Status is accentuated with the professional standards requirements for new, additionally manipulated products, such as irradiated ones, and especially with requirements for further testing, such as West Nile Virus testing. Tissue and cells banking Transplantation and tissue banking activities in the Republic of Croatia started in the 1980s. It is organised as public service and costs are cover by National Health Insurance Institute. Currently, there are three tissue banks for allogeneic tissues in Croatia: Hospital Centre Zagreb, University Hospital Centre Sisters of Mercy Clinic and General Hospital Varaždin. Additional three banks are performing hematopoietic stem cells banking for autologous use at the extremely small scale of the activity (less than 50 donors/recipients per year) - University Hospital Dubrava, University Hospital Merkur and University Hospital Centre Split (up to day no donors/recipients). At the moment costs of tissues and cells procurement, processing and distribution and donor testing are not recognised by the Croatian Health Insurance Fund. Tissues and cells banks operate inside the budget of the appertaining hospitals. Considering that the current model increases the hospital management costs, it cannot be expected from hospitals to promote tissue baking or, at least, promote tissue banking according to the high quality and safety standards. Such a constellation disturbs significantly availability of tissues and cells for transplantation, consequently directs to an import from economically more acceptable sources and directly jeopardises the self-sufficiency. Croatia has a long history in ART; first successful in vitro fertilization (IVF) was performed in 1983 in University Hospital Centre Zagreb. Today, Croatia has seven public ART centres, and a number of private centres. New Act on Medically Assisted Fertilisation was adopted by the Parliament in July All establishments were inspected. Ten new Ordinances on Medically Assisted Fertilisation were 3

4 adopted in June 2013 (OG 70/13). Croatian Health Insurance Fund pays for the six procedures in the case of impaired fertility for women up to 42 years. None of the public ART Establishments reaches number of 1000 procedures a year and only two are over 700. Considering the above paragraphs and having in mind the task of assurance of blood and blood products, tissues and cells and ART quality and safety, thorough revising and balancing corresponding financial models designing can be identified as exigency. Critical and direct consequence of expected financing model redesign is significant increase of tissues and cells transplantation programme activities, reaching not only self-sufficiency but expanding beyond. Targeted development of programme is provision of countries in the region with tissues and cells meeting EU requirements. Major support for reaching the mentioned result is envisaged to be obtained through future projects for development, enhancement and restructuring, recommended from experienced EU Member States. Clinical Hospital Centre Zagreb is the most experienced hospital in tissue banking in Croatia (bones, hematopoietic stem cells-hsc, ocular tissues and cord blood) and aims for international accreditation. IPA 2009 Twinning project Strengthening of institutional capacity for blood, tissue and cells was designed to guide haematopoietic and Cord Blood Bank (CB Bank) professionals in adopting knowledge, developing skills and establishing system adequate for application for JACIE and NetCord-FACT accreditation and personnel were preliminary educated in the field. Having in mind that preparing for the above mentioned accreditation is complex, demanding and day-to-day process, it is understandable that project could not cover it in full latitude and length. After being strengthened with accurate and appropriate guidelines, professionals are supposed to continue working in that aim persistently during and after finishing the IPA 2009 project. To assure sustainability of benchmarks achieved through the mentioned project and avoidance of unnecessary cost of potentially unsuccessful application for accreditation, final checking of completed accreditation preparedness is crucial and further efforts need to be invested with this goal. 3.2 Linked activities: IPA 2009 Strengthening the Institutional Capacity for Blood, Tissues and Cells Croatian Ministry of Health is the main beneficiary of the project, which consists of two components: Twinning and Supply. Twinning component of the overall project (Twinning no. HR/2009/IB/SO/03, Contract no ) is currently being implemented by Spain and Italy as the Twinning Member State partners. Project implementation started in June 2013 and the expected completion of the project activities is February 2015 (project implementation period is 15 months; however the project was suspended in the period from January 2014 to June 2014). Twinning project results related to development of procedures for strengthening of the institutional capacity for blood, tissues and cells of all institutions involved have been partially achieved up till now, while results related to trainings and strengthening of the staff capacities have not been achieved since the related activities have not started yet. Nevertheless, all of the project results are expected to be fully achieved by the end of the project implementation. Results of the IPA 2009 Twinning project are as follows: Recommendations for amendments of existing legislation and procedures regarding 4

5 blood, tissues and cells prepared; Institutional Capacity of Competent Authority and Blood, Tissue and Cells and Assisted Reproductive Technology Establishments for licensing and inspection enhanced; Croatian Institute for Transfusion Medicine (CITM) and Ministry of Health (MH) prepared for taking a role of an operational vigilance centre at national level; Measures for improvement of quality, safety and availability of human blood, tissues and cells, including ART prepared; Capacity of CA inspectors regarding the process of licensing and inspection enhanced; Capacity of Blood, Tissues and Cells and ART Establishments staff enhanced through targeted training; Clinical Hospital Centre Zagreb (CHCZ) prepared for upgrading as referral centre. Goals of the Twinning project include the upgrade of working practices of the Competent Authorities by strengthening their institutional and administrative capacities. The transfer of the best EU institutional models and expertise will bring the catalytic effect in the operations of Competent Authority through establishment of a new system for authorisation, inspection and supervision of Blood, Tissue and Cells Establishments according to the European regulations, and at the same time by providing support to the activities of Tissue Establishments. The institutional sustainability will be ensured by the documentary tools provided (guidelines, reports, training materials etc.) as well as by the enhanced staff capacity in achieving relevant working standards. In relation to the Supply component of the overall project, it is important to highlight that a positive impact should be notable in the area of the safety and quality standards of blood, tissues and cells for human application by providing financial support for equipping of facilities with state-of-the-art medical equipment. The financial sustainability will be ensured by planning adequate national means for the maintenance of the procured equipment. In terms of cross-border impact the project will help to guarantee the same standards of quality and safety of blood, tissue and cells exchanged with other EU Member States. Within the Supply Component five Lots have been contracted (Lot 1 Pathogen inactivation system delivered and in use as of November 2013, Lot 2 Plasma shock freezer- delivered and in use as of January 2014, Lot 3 Cell counter- delivered and in use as of December 2013, Lot 5 Inverted microscope equipped with digital camera, computer and analysis softwaredelivered and in use as of October 2013 and Lot 6 Tissue storage equipment- delivered and in use as of October 2013). The items planned but not procured through the project have also been delivered to key beneficiaries, i.e. item Automated System for Blood Group Serology Testing was delivered in September 2014 and item Automated Flow cytometer, six-colour dual-laser in September This Twinning light project is in the synergy with the above mentioned IPA 2009 Twinning project and there is no overlapping between the two projects since activities foreseen and/or implemented during IPA 2009 Twinning project do not cover topics envisaged under this Twinning light project (financial models, future projects in the sector, further accreditation application tasks). Moreover, the envisaged study visit under the IPA 2009 Twinning project covered the topics related to establishment of the regulatory system and organization of blood, tissues and cells centres in one Member State (Spain), while the study visits envisaged under this Twinning light project will enable participants to obtain first-hand knowledge of good practice in 5

6 blood, tissue and cells, and ART inspection, including planning, organisation and performing inspection and use of all inspection related documents in practice. Properly and duly educated inspectors with developed inspection skills are main instrument for Directives implementation surveillance and for the practical on-the-job training in the Member State through study visits is crucial in realizing this goal which cannot be achieved solely through workshops and seminars in the Beneficiary country. Other linked activities: In the period from 2009 to 2013, the following activities were executed: TAIEX Study Visit on Tissue Bank and Competent Authority in Barcelona (2-5 June 2009, 4 participants) TAIEX Study Visit on Quality Management System in Tissue Bank in Berlin (6-10 July 2009, 3 participants) TAIEX Workshop on Tissue Bank Management for Regulators in Zagreb (9-11 December 2009, 36 participants) Workshop Procurement and processing of tissue and cells (4 days in September 2010, participants) TAIEX Expert Mission - National plan for Tissue and Cells Establishment (July 2010, 6 participants) TAIEX Expert Mission on tissue and cells (Improvement of safety and quality of tissue and cells) (2 days in December 2010, 3 participants) TAIEX Study visit on Spanish National Transplant Organization (October 2010, 3 participants) TAIEX Expert Mission on Donor Quality Assurance Programme (November 2010, 5 participants) TAIEX Expert Mission on Transplant Registry (November 2010) Workshop on Training for ICU doctors and hospital transplant coordinators (November 2010, 65 participants) TAIEX Workshop on Quality Systems in Transfusion Medicine (2 days in December 2010, 120 participants) TAIEX Study Visit on UK s Human Fertilization and Embryology Authority (April 2011, 3 participants) TAIEX Expert Mission on Ocular Tissue Bank Inspection (May 2011) TAIEX Expert Mission on Skin Bank Inspection (February 2012) TAIEX Workshop on Quality Systems in Ocular Tissue Banking INT MARKT (January 2013) TAIEX Workshop on Deceased Donation and Transplantation INT MARKT (July 2013) These kinds of activities are also planned to continue in the upcoming years. They do not interfere/overlap with the IPA 2009 project or this Twinning light project since they ensure adequate training of Croatian experts in the many different areas, thus facilitating implementation of both IPA 2009 Twinning and this Twinning light project. 6

7 3.3 Results: Result 1: Recommendations for financial models of transfusion medicine service, tissue and cells banking and ART prepared Indicators of achievement: Current financing model of transfusion medicine service reviewed and Review Report with detailed recommendations on the best financial practice prepared Current financing model of tissues and cells banking system, including the ART, reviewed and Review Report with detailed recommendations on the best financial practice prepared Result 2: Recommendations for future projects with the purpose of further development, enhancement and restructuring of tissues and cells transplantation programme, ART service and blood transfusion service prepared Indicator of achievement: Gaps and Needs Analysis related to further development, enhancement and restructuring of tissues and cells transplantation programme, ART service and blood transfusion service performed and Assessment Report with recommendations for future projects prepared Result 3: University Hospital Centre Zagreb s Hematopoietic Stem Cells (HSC) Bank and Cord Blood (CB) Bank prepared for the international accreditation application Indicators of achievement: Level of preparedness of the HSC Bank and CB Bank for the international accreditation application assessed and detailed Assessment Report prepared HSC Bank and CB Bank experts (5 representatives) and the Competent Authority experts (4 representatives) for JACIE and FACT-NetCord accreditation application trained through workshops on the following topics: - Preparation of the documentation for JACIE accreditation - Preparation of the documentation for FACT-NetCord accreditation - Review of the documentation prepared for JACIE accreditation - Review of the documentation prepared for FACT-NetCord accreditation Study tour (3 working days; 3 participants from HSC/CB Bank and 2 participants from the Competent Authority) in an EU Member State accredited hematopoietic stem cells bank and cord blood bank conducted and corresponding report prepared Result 4: Capacity of the Competent Authority inspection unit in the field of blood, tissue and cells banking strengthened Indicators of achievement: Competent Authority inspectors practically trained through real (actual) inspection in an EU Member State as follows: - Inspection study tour (4 working days; 4 participants) to Blood Establishment conducted and corresponding report prepared 7

8 - Inspection study tour (4 working days; 4 participants) to Tissues and Cells Establishment conducted and corresponding report prepared - Inspection study tour (4 working days; 4 participants) to ART Establishment conducted and corresponding report prepared 3.4 Activities: Member State is kindly requested to further develop activities in the submitted proposal which are needed in order to achieve the results stipulated in the fiche. Two visibility events will be organized in the course of the implementation of the project; Kick-off meeting at the start of the implementation and the Final meeting at the end of the implementation of the project activities. 3.5 Means/ Input from the MS Partner Administration: MS Project Leader may participate in the project also as the short-term expert (STE) and in this case the MS Project Leader should satisfy requirements stipulated in the fiche for both the Project Leader and the relevant STE profile Profile and tasks of the Project Leader Profile of the Project Leader Requirements: - University level education or equivalent professional experience of 10 years in the field of medicine - 6 years of professional working experience in the field of transfusion medicine and/or tissues and cells banking - Experience in project management - Working level of English language - Proven contractual relations to public administration or mandated body, as defined under Twinning manual Computer literacy Assets: - Experience in implementation of EU Directives and standards for blood and/or tissues and cells - Experience in EU funded project Tasks of the Project Leader: - Overall management and coordination of the whole project and particular activities, in cooperation with Croatian PL - Co-ordination of MS experts work and availability - Project reporting - Organization of study visits - Participation in Steering Committee Meetings - Mobilizing short - term experts 8

9 - Ensuring backstopping and financial management of the project in the MS - Overall responsibility and direction of the MS Twinning partner inputs and proposing corrective measures, if needed Profile and tasks of the short-term experts For each of the proposed experts in the submitted proposal the Member State is kindly requested to indicate the experts profile. Profile of the Short-term expert 1 (STE 1) Expert for financial management Requirements: - University level education or equivalent professional experience of 8 years in the health system - 3 years of working experience in the health system - Experience in developing or analyzing financing model in the health system - Working level of English language - Proven contractual relations to public administration or mandated body, as defined under Twinning manual Computer literacy Asset: - Experience in providing trainings on financing model in the health system Tasks of the Short-term expert 1: - Reviewing financial model of transfusion medicine service - Reviewing financial model of tissues and cells banking system - Reviewing financial model of ART service - Preparing relevant review reports with recommendations - Conducting gaps and needs analysis and preparing assessment report with recommendations for future projects - Close cooperation with the Croatian experts in undertaking all activities - Participating in all relevant project activities in cooperation with other short-term experts Profile of the Short-term expert 2 (STE 2) Expert for HSC banking accreditation Requirements: - University level education or equivalent professional experience of 8 years in the field of hematopoietic stem cells (HSC) banking or cord blood (CB) banking - 4 years of experience in the field of HSC or CB banking - Experience in implementation of accreditation standards - Working level of English language - Proven contractual relations to public administration or mandated body, as defined under Twinning manual Computer literacy 9

10 Assets: - Working experience as a certified FACT-NetCord or JACIE inspector - Experience in providing trainings related to FACT-NetCord or JACIE accrediation standards Tasks of the Short-term expert 2: - Assessing preparedness for the international accreditation and preparing assessment report with recommendations - Conducting trainings on preparation of international accreditation - Close cooperation with the Croatian experts in undertaking all activities - Participating in all relevant project activities in cooperation with other short-term experts Profile of the Short-term expert 3 (STE 3) Expert for projects in substances of human origin field Requirements: - University level education or equivalent professional experience of 8 years in the field of medicine - 4 years of experience in the field of substances of human origin - Working level of English language - Proven contractual relations to public administration or mandated body, as defined under Twinning manual Computer literacy Assets: - Experience in providing trainings in the field of substances of human origin - Experience in project preparation in the health sector under structural or cohesion funds Tasks of the Short-term expert 3: - Conducting gaps and needs analysis and preparing assessment report with recommendations for future projects - Close cooperation with the Croatian experts in undertaking all activities - Participating in all relevant project activities in cooperation with other short-term experts Note: The pool of experts should include: - At least one short-term expert who in addition to the respective profile requirements has experience in FACT-NetCord accreditation standards; - At least one short-term expert who in addition to the respective profile requirements has experience in JACIE accreditation standards. 10

11 4. Institutional Framework Ministry of Health, as the Competent Authority is the main beneficiary institution for the overall implementation of the project activities. The project stakeholders are as follows: University Hospital Centre Zagreb Hematopoietic Stem Cell Bank and CB Bank as well as Blood Establishments, Tissue and Cells Establishments and ART Establishments. The aim of the Ministry of Health is improvement of the health system so it can satisfy the overall needs of Croatian citizens regarding quality and expert health care which involve disease prevention, professional illness prevention, health education, early disease risk identification and treatment as well as rehabilitation of the patients. Currently there are two different technical units of the Competent Authority (CA) within the Ministry, which are responsible for performing the tasks under the competence stated in accordance with the requirements of European Tissue and Blood Directives. One unit is the Institute for Biomedicine and Transplantation, established mainly for the purpose of authorization procedures, biovigilance and activity monitoring. The authorization for Blood and Tissue Establishments grants the Minister based on the inspection report. The other unit is Service for Blood, Tissues and Cells Inspection, established mainly for the purpose of inspection, legislation enforcement monitoring and biovigilance. The above mentioned units cooperate, among themselves and healthcare establishments, in providing the best possible service to the general public. University Hospital Centre Zagreb (UHC), established in 1942, is the most experienced hospital in tissue banking in Croatia. In the UHC s Multi-tissue Bank bones, allogeneic and autologous haematopoietic stem cells, cardiovascular tissues, ocular tissues and cord blood are banked. UHC s haematopoietic stem cells bank is Croatian only allogeneic and only cord blood bank. The total number of people participating in the project (working in the abovementioned health establishments) is expected to be: for blood approx. 15, for HSC bank approx. 7 and for ART approx. 15. The number should be extended to 4 blood and tissues inspectors and 3 Institute for Biomedicine and Transplantation s employees that will be trained to adequately perform their assignments in concordance with the EU Directives and Croatian legislation. Coordination of the project will be under the responsibility of the Ministry of Health. The results of the project are not expected to lead to a change of the institutional framework as described. Two Steering Committee meetings will be held for the purpose of reviewing the progress made under the project as well as to discuss results achieved and/or problems occurred. The first Steering Committee meeting will be held during the third month of project activities implementation in order to discuss and comment the draft start-up report. The second Steering Committee meeting will be organised during the last month of the implementation period of the Action to discuss the draft final report. It should be noted that the participation of the Member State Project Leader in Steering Committees meetings has to be combined with expert missions in case the Member State Project Leader is also a short-term expert in the twinning light project. If the Member State Project Leader is not short-term expert in the twinning light project then his visits to Croatia, (one visit every three months) as part of his overall task to ensure coordination and political 11

12 steering of the project, should be organised at the same time as the two Steering Committee meetings of the project. The exact participants of the Steering Committee meetings will be defined during the implementation of the project, but will at least include the following members: BC Project Leader MS Project Leader CFCA Project Manager MRDEUF Sector Manager The beneficiary is committed to provide all necessary infrastructure such as office space and desktop computers with internet connection for experts, venue for holding seminars and workshops, and to ensure the necessary local staff/experts inputs. 5. Budget Contribution to institutional capacity for blood, tissue and cells in the implementation of the Directives 2002/98/EC and 2004/23/EC (CRO BTC) Twinning Light Contract IPA Community Contribution 90% EUR National Co-financing TOTAL 10% EUR EUR The total amounts of the IPA Community Contribution and National Co-financing stipulated in the above table represent the total maximum amounts and therefore, they may be reduced at the level of the Twinning light contract, while the relevant ratio (percentages) should be maintained as fixed. The co-financing requirement foreseen under IPA will be considered fulfilled according to the provision of the relevant Financing Agreement. Interpretation costs will be reimbursed from the budget only for the purpose of workshops and seminars, up to 7% of the Contract amount can be used for translation and interpretation purposes. Provisions for visibility costs and expenditure verification costs should be included in the budget. 6. Implementation Arrangements 6.1 Implementing Agency responsible for tendering, contracting and accounting: Central Finance and Contracting Agency (CFCA) Ulica grada Vukovara Zagreb, Croatia Ms Nataša Mikuš Žigman, Director Phone: Fax:

13 Twinning Administrative Office Central Finance and Contracting Agency Ulica grada Vukovara Zagreb, Croatia Ms Nirvana Sokolovski, Twinning NCP Phone: Fax: twinning@safu.hr 6.2 Main counterpart in the BC: Deputy Senior Programme Officer (SPO) Ms Antoaneta Bilić, Deputy SPO Ministry of Health Ksaver 200a Zagreb, Croatia Phone: Fax: address: antoaneta.bilic@miz.hr BC Project Leader Ms Vanja Nikolac, Head of Service for Blood, Tissues and Cells Inspection Ministry of Health Ksaver 200a Zagreb, Croatia Phone: Fax: vanja.nikolac@miz.hr 6.3 Contracts: It is envisaged that the Project will be implemented thorough one Twinning light contract, with a maximum amount of ,00 EUR. 6.4 Reporting: The Start-up Report will cover first two months of the contract and will be submitted during the third month. The Start-up report should: - Clearly define the aims and purpose of the aid provided by the project, - Give detailed description of the content of particular parts of the project, - Work out in detail the activities carried out and the results achieved, - Work out in detail all modifications agreed with the beneficiary institution, - Review difficulties met during the implementation of the project and measures that were undertaken for their removal, - Provide all findings obtained in the meanwhile and preliminary conclusions, and 13

14 - Contain a general plan of activities for the implementation of the remained duration of the project. The Final Report shall be submitted within three months upon the completion of the project activities and in any case within the legal duration of the project, and it should contain the following: - Complete review of all activities carried out by MS experts during the implementation of the project, - Achieved progress concerning each activity, - Summary of all project results, with particular emphasis on mandatory results, - Estimation of the project impact compared with the project aims and measures of the achieved progress, - Identification of all important problems met during the implementation of the contract and solutions that have been applied, - Lessons drawn from the project, and - Recommendations for further steps in future projects The reports must be endorsed and countersigned by the beneficiary, who may make additional comments. Reports shall be submitted to Ministry of Health, the Central Finance and Contracting Agency, the Ministry of Regional Development and EU Funds and the concerned service of the European Commission in a form of 3 hard copies and an electronic version. All reports should be written in English. 6.5 Language: English will be the working language of this Twinning light project. 7. Implementation Schedule (indicative) 7.1 Launching of the call for proposals: 4Q Start of project activities: 2Q Project completion: 4Q Duration of the execution period (number of months) - 9 months; the execution period will end 3 months after the implementation period of the Action (work plan) which will take 6 months. 8. Sustainability The Twinning light project will contribute to the improvement of safety and quality of blood and tissues and cells according to the requirements of the Directives 2002/98/EC and 2004/23/EC. This project is a follow up of the IPA 2009 Twinning project Strengthening the Institutional Capacity for Blood, Tissues and Cells and represents further improvement of 1 This Twinning light project should start after IPA 2009 Twinning project Strengthening the Institutional Capacity for Blood, Tissues and Cells, which is expected to finish in 2Q

15 health care system. The mentioned IPA 2009 Twinning project and this Twinning light project will provide the base necessary for planning other compatible projects that will progress in the future EU funds. It is necessary to continue the mentioned improvement, especially in the field of biomedicine as well as competences of experts for blood, tissues and cells and ART through training and education, necessary in order to bring safety, quality and accessibility of the human blood, tissues and cells to the European level. In this sense, improvement of BTC experts competences will be ensured through trainings, workshops and study visits which will form the base for further trainings, as trained BTC experts will further disseminate the obtained knowledge. After the end of the project, University Hospital Centre Zagreb s Hematopoietic Stem Cells (HSC) Bank and Cord Blood (CB) Bank will apply for the international accreditation. With accreditation contribution part to the haematopoietic stem cells banking as a constituent part of international register will be ensured and access of stem cells transplantation for patients in the Republic Croatia will be increased. Exchange of stem cells between the Republic of Croatia and EU countries according to the EU standards will be also provided. Finally, financial models will be established and implemented, which will insure financial sustainability of haematopoietic stem cells banking. Development and implementation of efficient financial models for blood, tissues and ART will ensure realistically base for full implementation of Directives requirements. 9. Crosscutting issues Based on the fundamental principles of promoting equality and combating discrimination, participation in the project will be guaranteed on the basis of equal access regardless of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. 10. Conditionality and sequencing Conditionality N/A Sequencing This Twinning light project should start after IPA 2009 Twinning project Strengthening the Institutional Capacity for Blood, Tissues and Cells, which is expected to finish in the second quarter of Twinning light contract resulting from this call for proposals can be concluded upon finalisation and achievement of all the results of the IPA 2009 Twinning project Strengthening the Institutional Capacity for Blood, Tissues and Cells. 15

16 ANNEXES TO PROJECT FICHE 1. Logical framework matrix in standard format 16

17 Annex 1. Logical framework matrix in standard format Contribution to institutional capacity for blood, tissue and cells in the implementation of the Directives 2002/98/EC and 2004/23/EC (CRO BTC) Ministry of Health Programme name and number: IPA 2011 FF RAC Contracting period expires: 3 years following the date of conclusion of the Financing Agreement Total budget: ,00 EUR Overall objective Objectively Verifiable Indicators Sources of Verification Increase of quality and safety of blood and availability, quality and safety of tissues and cells for human application in order to Quality and safety of blood, tissues and cells for human application increased and in accordance with the requirements of assure the highest possible level of public Directives 2002/98/EC and 2004/23/EC health protection. achieved Directives 2002/98/EC and 2004/23/EC fully implemented University Hospital Centre Zagreb s Hematopoietic Stem Cells (HSC) Bank and Cord Blood (CB) Bank accredited National register on licensed blood, tissue and cells establishments Annual report on tissue, cells and blood activities for Republic of Croatia National biovigilance report sent to EC Project purpose Objectively Verifiable Indicators Sources of Verification Assumptions Enhancement of capacity of the Competent Recommendations for financial models Meeting minutes Authority for Blood, Tissues and Cells prepared with the purpose of assuring adequate and Recommendations for future projects Reports from study visits timely implementation of requirements prepared List of participants of within Directive 2002/98/EC and Directive University Hospital Centre Zagreb s workshops, meetings and 2004/23/EC in Blood, Tissues and Cells Hematopoietic Stem Cells (HSC) Bank and visibility events Establishments. Cord Blood (CB) Bank prepared for the Disbursement period expires: 4 years following the end date for contracting IPA financing: EUR (90%) National co-financing: EUR (10%) 2 Commitment and support of the Government and Ministry of Health Good coordination and real-time information transfer from blood, tissues and cells establishments Qualified and experienced MS experts 2 The total amounts of the IPA Community Contribution and National Co-financing stipulated in the above table represent the total maximum amounts and therefore, they may be reduced at the level of the Twinning light contract, while the relevant ratio (percentages) should be maintained as fixed. The co-financing requirement foreseen under IPA will be considered fulfilled according to the provision of the relevant Financing Agreement. 17

18 international accreditation application Capacity of the Competent Authority inspection unit strengthened Report and recommendations produced under the project Twinning light project reports Results Objectively Verifiable Indicators Sources of Verification Assumptions Result 1: Recommendations for financial Current financing model of transfusion models of transfusion medicine service, medicine service reviewed and Review tissue and cells banking and ART prepared Report with detailed recommendations on the best financial practice prepared Documentation produced under the project Current financing model of tissues and cells banking system, including the ART, reviewed and Review Report with detailed recommendations on the best financial practice prepared in the implementation of Directives 2002/98/EC and 2004/23/EC Respective authorities and institutions have sufficient capacities and are willing to cooperate on the issues linked to implementation Commitment and support of the Government and Ministry of Health Good coordination and real-time information transfer from blood, tissues and cells establishments Qualified and experienced MS experts in the implementation of Directives 2002/98/EC and 2004/23/EC Result 2: Recommendations for future projects with the purpose of further development, enhancement and restructuring of tissues and cells transplantation programme, ART service and blood transfusion service prepared Gaps and Needs Analysis related to further development, enhancement and restructuring of tissues and cells transplantation programme, ART service and blood transfusion service performed and Assessment Report with recommendations for future projects prepared Documentation produced under the project Respective authorities and institutions have sufficient capacities and are willing to cooperate on the issues linked to implementation 18

19 Result 3: University Hospital Centre Zagreb s Hematopoietic Stem Cells (HSC) Bank and Cord Blood (CB) Bank prepared for the international accreditation application Level of preparedness of the HSC Bank and CB Bank for the international accreditation application assessed and detailed Assessment Report prepared HSC Bank and CB Bank experts (5 representatives) and the Competent Authority experts (4 representatives) for JACIE and FACT-NetCord accreditation application trained through workshops on the following topics: -Preparation of the documentation for JACIE accreditation -Preparation of the documentation for FACT-NetCord accreditation -Review of the documentation prepared for JACIE accreditation -Review of the documentation prepared for FACT-NetCord accreditation Study tour (3 working days; 3 participants from HSC/CB Bank and 2 participants from the Competent Authority) in an EU Member State accredited hematopoietic stem cells bank and cord blood bank conducted and corresponding report prepared Documentation produced under the project Result 4: Capacity of the Competent Authority inspection unit in the field of blood, tissue and cells banking strengthened Competent Authority inspectors practically trained through real (actual) inspection in an EU Member State as follows: -Inspection study tour (4 working days; 4 participants) to Blood Establishment conducted and corresponding report prepared Documentation produced under the project 19

20 -Inspection study tour (4 working days; 4 participants) to Tissues and Cells Establishment conducted and corresponding report prepared -Inspection study tour (4 working days; 4 participants) to ART Establishment conducted and corresponding report prepared Activities Means Specification of costs Assumptions Activities to be implemented correspond to the activities developed in the selected MS proposal. Review, gaps and needs analysis, assessment, workshops, study tours ,00 EUR In line with the assumptions specified for results. Preconditions: N/A 20