Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final) -

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1 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final) - EUROPEAN UNION The European Union IPA 2013 programme for Kosovo REPUBLIC OF KOSOVO TECHNICAL ASSISTANCE FOR THE ANIMAL HEALTH DEPARTMENT OF THE KVFA AND THE FOOD AND VETERINARY LABORATORY (KOSOVO) REF: EuropeAid/133795/DH/SER/XK Inception Report Final 15 April 2015 Consortium NIRAS/Agrotec SpA /IZSve 1

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3 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Project Identification and Information Programme : IPA 2013 Project Title Project Short Name Project ID code : Technical Assistance for the Animal Health Department of the KFVA and the Food and Veterinary Laboratory (Kosovo) : KAHL project : EuropeAid133795/DH/SER/XK Contract No : 2014/ Project location Duration Project financing : Kosovo : 24 months: 23-Feb-15 to 22-Feb-17 TA team : 1,077,750 Incidental expenditure : 200,000 Expenditure verification : 15,000 Supply tender(s) : 0 Government contribution : 0 Total project value : 1,292,750 Target groups Current project status Report Information Report Date Report author : The direct beneficiary institution is the Kosovo Food and Veterinary Authority and livestock keepers will be indirect beneficiaries and stakeholders : Inception phase Inception report 15-Apr-15 Nic Honhold, Project Team leader Other contributors Stefano Nardelli on laboratory management Andres Jatsa on information technology Anni McLeod on livestock economics Birol Urcan on communications and media This document has been produced with the financial assistance of the European Union The contents of this publication are the sole responsibility of the author/contractor/implementing partner and are in no way be taken to reflect the views of the European Union. Consortium Agrotec SpA /NIRAS/IZSve

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5 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- TABLE OF CONTENTS ABBREVIATIONS AND ACRONYMS INTRODUCTION EXECUTIVE SUMMARY AND RECOMMENDATIONS REVIEW OF PROJECT DESIGN/FINANCING PROPOSAL Policy and programme context, including linkage to other ongoing operations/activities Objectives to be achieved (Overall Objective, purpose, results) Activities Resources and budget Project Team Incidental Expenditures Assumptions and risks Management and coordination arrangements Financing arrangements Monitoring, review and evaluation arrangements Key Quality/Sustainability issues WORKPLAN FOR THE NEXT PERIOD (ANNUAL PLAN) Results to be delivered Activity schedule Resource schedule and budget Monitoring and Evaluation Updated risk management plan Special activities to support sustainability ANNEXES Annex A Updated LogFrame Annex B Deliverables and sub-activities Annex C Indicative Timetable of Activities including Deliverables for PY1 and PY2 Annex D Indicative Personnel Deployment for PY1 and PY2 Annex E Indicative Incidental Expenditures Budget for PY1 and PY2 Annex F Assumptions and Risks including Risk Management Plan Annex G Report of the KE2 Animal Health Annex H Report of the SSTE Information Technology Annex I Report of the SSTE Communication and Media Annex J Report of the SSTE Livestock Economics Consortium Agrotec SpA /NIRAS/IZSve

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7 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- ABBREVIATIONS AND ACRONYMS AH AP BIP CA COA CAP CP CVO DFR EC EU EUO EUR FAO FR FVO GDP GIS HQ I&R IPA IPARD IR ISO IT JSTE KE KFVA Animal Health Accession Partnership Veterinary (or Phytosanitary) Border Inspection Post Competent Authority Contracting Authority Common Agricultural Policy Contingency Plan Chief Veterinary Officer Draft Final Report European Commission European Union European Union Office to Kosovo Euro Food and Agriculture Organisation of the United Nations Final Report Food and Veterinary Office of EC Gross Domestic product Geographic Information System Headquarters Identification and Registration (of livestock keepers and livestock) Instrument for Pre-Accession Assistance Instrument for Pre-Accession Assistance for Rural Development Inception Report International Organization for Standardization (in Geneva) Information Technology Junior Short Term Expert Key Expert Kosovo Food and Veterinary Agency KOM Kick Off Meeting LAN Local Area Network LIMS Laboratory Information Management System Log Frame Logical Framework (project planning methodology) M&E Monitoring and Evaluation MAFRD Ministry of Agriculture, Forestry and Rural Development Consortium Agrotec SpA / NIRAS / IZSVe 4

8 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- MIPD OIE OM PCM PRAG PSC SR SSTE TA TAT TL ToR TQA UNMIK VIS VPH WB WD WG WHO Multi-annual Indicative Planning Document Office International des Epizooties Operational Manual Project Cycle Management (EU Guidelines) Practical Guide to conduct procedures for EU external actions Project Steering Committee Small Ruminants Senior Short-Term Expert Technical Assistance Technical Assistance Team Team Leader Terms of Reference Technical Quality Assurance United Nation Mission in Kosovo Veterinary Information System Veterinary Public Health (= consumer health protection) World Bank Working Day Working Group World Health Organization Consortium Agrotec SpA / NIRAS / IZSVe 5

9 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 1 INTRODUCTION The contents of this Inception Report have been produce to conform to the guidelines for an Inception Report given in the EU Project Cycle Management Guide of March 2004 downloaded from on 26-Mar-15. The project name is Technical Assistance for the Animal Health Department of the KFVA and the Food and Veterinary Laboratory (Kosovo) and the short name for the project is KAHL Project. The project is based in Pristina but will involve implementation in all parts of Kosovo. The project has a duration of 24 months and implementation commenced on 23-February The project has a total budget of 1.293million. This is made up of million for the technical assistance team and 200,000 for Incidental expenditure. The key stakeholder and beneficiary is the Kosovo Food and Veterinary Authority (KFVA). The Kosovan name is Agjencia e Ushqimit dhe Veterinarisë (AUV). This unit is currently situated within the Office of the Prime Minister although it has in the past been part of the Ministry of Agriculture, Forests and Rural Development (MAFRD) and may again become part of that organisation. The overall objective of the project is to strengthen safeguarding measures of animal health from introduction of exotic diseases and reinforce the capacity to implement control and eradication pans for diseases present in the country The project is currently in the Inception Phase which will run until 07 April 2015 after which the implementation phase will commence when/if the Inception Report is approved by the Project Steering Committee (PSC). Consortium Agrotec SpA / NIRAS / IZSVe 6

10 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 2 EXECUTIVE SUMMARY AND RECOMMENDATIONS The KAHL project is a relatively small highly focused project with a single clear beneficiary, the Kosovo Food and Veterinary Agency (KFVA). As such, it is less complex than many projects. The majority of the funding is for the Technical Assistance Team (TAT) who will work closely with their counterparts in KFVA throughout the project. The project will achieve the overall objective through a set of 11 Results and 14 Activities, The overall objective and results have been reviewed in the light of information obtained during the Inception Phase and are relevant and feasible. There is one issue in that Result 11 requires an updated Laboratory Management System to be produced whereas both the Activity related to this (Activity 14) and the Incidental Expenses only allow for the production of a draft proposal for such a system. Implementation of the system, and so full achievement of Result 11, will depend on the KFVA having sufficient financial allocation. For the purposes of the project, producing the draft proposal and required budget will represent achievement of Result 11. In the Activities, there is one main shift in emphasis required. In Activity 9, the final sentence states that The contractor shall be responsible for the operational delivery and management of the [brucellosis] programme during the lifetime of the project. This would not be technically desirable as it would result in substitution rather than building capacity. Nor is it financially feasible within the funding available to the project. Discussion with both the beneficiary (KFVA) and the contracting authority (the EUO) has led to agreement that this be re-emphasised to the project giving close support to the management and monitoring of the programme, but that the KFVA will retain the responsibility for the operational delivery and management of the programme. This shift in emphasis is described in more detail in section 3.3 Significant changes are proposed in the composition of both the Senior Short Term Expert (SSTE) and the Junior Short Term Expert (JSTE) posts and the days allocated to each post. This proposal has been developed in close co-operation with the beneficiary and project senior specialists; it has been seen and agreed by both the KFVA and the EUO. The changes have been made to match the current needs of the Project and the KFVA in order to achieve the results and overall objective of the project. The reader is referred to section for the details of the proposal. However, it should be noted that there have been no changes in the total number of Working Days (WD) for Key Experts (KEs), SSTEs or JSTEs. The total days for each category and overall for the project remains as laid out in the Annex II: Terms of Reference. Other than these changes, the project overall objective, results and activities have been found to be relevant and feasible with a few minor clarifications. A system for a clear method of monitoring project progress has been put in place. The project has 11 Results and 14 Activities. Results are identified by R1 to R11 and Activities by A1 to A14 with the numbering being the same as in the project ToRs (Annex II). The Activities have been subdivided into sub-activities, each of which has been allocated to the relevant Result. For each sub-activity, one or more Deliverables has been identified and described. There is a clear audit trail from sub-activity to Deliverable to Result to Overall Objective. Consortium Agrotec SpA / NIRAS / IZSVe 7

11 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Each sub-activity is identified in the form AN.n with A indicating that it is an Activity, N the Activity number in the ToR from which it has come and n the sub-activity identifier. These sub-activities have then been allocated to the Result to which they contribute and put in the order in which they need to be completed in order to achieve the Result. Each sub-activity has one or more Deliverables, which will mostly be in the form of reports detailing the outcome of the sub-activity. These Deliverable are identified as DN.n with D indicating a deliverable, N the same number as the Result to which they indicate progress and n the order in which they will be produced. This may sound complex but it produces a clear and easily monitored system in which for each Result there are defined Deliverables and each deliverable shows progress towards the Result and which sub-activities have been progressed and/or completed. The Log Frame (Annex A) has been produced by Result and then by sub-activity by order of implementation and also shows the Deliverable codes. The Deliverables are then detailed in Annex B with the sub-activity from which they come. The indicative Timetable of Activities indicates when each sub-activity and related Deliverables is expected to be achieved and this is shown in Annex C for the two year duration of the project. The major resource of the project is the project Technical Assistance team. An indicative timing of these inputs is shown in Annex D for the two year duration of the project. An indicative budget for Incidental Expenditures has been developed which is shown in Annex E in detail and summarised in Section The emphasis is on disease surveillance and vaccination monitoring for which around 50% of the budget is allocated. Both study visits and awareness campaign have around 20% of the funds allocated with the remaining 10% for training. This understates the training element as it is a large component of the study visits as well as being a direct output from on the job training during the deployment of the SSTEs. An Inception Report also contains the Annual Work Plan (AWP) for the first Project year (PY1). The AWP shows the progress expected during that year and indicative plans for the resources to be used, both human and financial. As this is a focused project with a two year duration, indicative resource plans have been drawn up for both years as whatever is not deployed in PY1 will need to be deployed in PY2. These will, of course, need to be reviewed and, where needed, amended at the end of PY1 to produce AWP2, but the indicative plans for both PY1 and PY2 are shown in Section 4 and the relevant annexes. Consortium Agrotec SpA / NIRAS / IZSVe 8

12 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 3 REVIEW OF PROJECT DESIGN/FINANCING PROPOSAL During the inception phase, the KAHL Project Team has consulted widely including making visits to: Kosovo Food and Veterinary Agency (KFVA) o Animal Health and Welfare Directorate o Identification and Registration Sector o Animal Health Laboratory Kosovo Veterinarians Order Livestock Department, Ministry of Agriculture, Forest and Rural Development (MAFRD) Veterinary School, Agriculture Faculty, University of Pristina Department of Communicable Diseases, National Institute of Public Health Faculty of Economics of the Agriculture University of Pristina European Union Office EU funded Animal Diseases Project (Rabies and CSF) Reports of the EU Twinning Projects Information gained from all these sources has been used to review the relevance of the project, the feasibility of the project and any required changes to the design of the project from that proposed in the Technical Proposal. Added to this are inputs from the KE for Animal Health and the SSTEs for Information Technology, Communications and Livestock Economics. 3.1 Policy and programme context, including linkage to other ongoing operations/activities Achievement of Candidate Country Status for Membership of the European Union has been and remains a prime aspiration for both the Kosovo administration and the European Commission. Much, of course, remains to be done in order for Kosovo to catch up with the neighbouring countries that are already EU Candidates. Amongst others, an important imperative for Kosovo, from the general point of view of its desire for closer integration with the rest of Europe and considering the steadily improving animal health status of its EU Candidate neighbours, in part made possible by IPA funding and a progression of Commission sponsored technical assistance projects, is to implement enhanced measures for the prevention, control and, as appropriate, eradication of livestock diseases. Particular attention needs to be given to those diseases that are damaging to production and cause economic loss to farmers, those that are harmful to human health and those that are transboundary in their epidemiology and which are, therefore, capable of re-infecting areas, even across national borders, in which a disease has already been eliminated at significant effort and cost. Consortium Agrotec SpA / NIRAS / IZSVe 9

13 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- This Project aims at the enhancement of the capacity and capability of the veterinary services in Kosovo to achieve these necessary improvements in animal health control including diagnostics. In order to do this, the Project Team will adopt a methodical and analytical approach to the difficulties in the veterinary services of Kosovo and in the veterinary laboratory. This will be based on close liaison with the main beneficiaries and key stakeholders throughout the Project. The Project Team will undertake intensive fact-finding within the relevant sectors and derive detailed implementation plans from this to undertake the necessary activities to create a sustainable upgrading of the capacity of the veterinary services in Kosovo to control and eradicate livestock diseases, working to particularly to EU but also other relevant international standards. Given the necessity to align animal health policies and standards with the EU, the project remains highly relevant for Kosovo. 3.2 Objectives to be achieved (Overall Objective, purpose, results) The Overall Objective, Project Purpose and results are taken directly from the ToR of the project, i.e. Annex II. Overall Objective The overall objective of the project is to strengthen safeguarding measures of animal health from the introduction of exotic diseases and reinforce the capacity to implement control and eradication pans for diseases present in the country Project purpose: The purposes of the project are as follows: a) To ensure a high level of public health and food safety by minimising the incidence of biological and chemical risk to humans b) To promote animal health by preventing/reducing the incidence of animal diseases and in this way to support farming and the rural economy c) To improve economic growth/cohesion/competitiveness assuring free circulation of goods and proportionate animal movements d) To promote farming practices and animal welfare related threats and minimise environmental impacts in support of the EU Sustainable Development Strategy Results: The results to be achieved are divided between two components, Animal disease control and laboratory testing Consortium Agrotec SpA / NIRAS / IZSVe 10

14 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Component 1: Animal disease control Result 1: Result 2: Result 3: Result 4: Result 5: Result 6: Development plan for the animal health unit, including annual and multiannual work plan is prepared Surveillance and vaccination programme for diseases identified by the KFVA and those for which reporting is compulsory have been drafted and implemented Cost benefit analysis for control and/or eradication of selected animal diseases is prepared Contingency plans for selected animal diseases have been reviewed and updated Control plan for brucellosis and clostridial diseases have been reviewed and updated. A list of needed diagnostic kits, biological materials and other consumables needed for implementation of the programme for control of brucellosis and clostridial diseases has been drafted; laboratory capacities and potential inclusion of new tests and techniques have been reviewed and updated. An awareness campaign on the importance of disease control and eradication for farmers and other stakeholders concerned has been designed and implemented Component 2: Laboratory testing Result 7: Result 8: Result 9: Result 10: Result 11: Training need analysis and training for the laboratory staff has been carried out A list of test and analysis to be included in the range of laboratory services to be performed has been drafted A list of missing equipment and technical specifications for these equipment has been prepared Laboratory staff trained and capable of performing laboratory tests on the selected animal diseases Laboratory management systems including document management and communications system have been reviewed and updated These results are clear but there are some minor issues to address. Result 10 is the implied outcome of Result 7. It has no specific activities that relate to it alone For brucellosis, the actions required in Result 2 will depend on the outcome of Result 5. The result implied in Result 11 is that an actual system will be produced or updated by the project, whereas the activities and incidental expenditures do not extend this far (see in Activities below) However, these are, as stated, minor issues that do not require any significant changes, just a flexible approach. The results are relevant and feasible. Consortium Agrotec SpA / NIRAS / IZSVe 11

15 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 3.3 Activities Annex II, the project ToR details 14 activities. These activities taken together are adequate to achieve the 11 results. However, as can be seen by the numbering, there is more than one identified activity per result. In some cases actions in more than one activity may contribute to one result (e.g. cost-benefit analysis in Activity 1 and 3 relate to Result 3) and actions in a single activity may contribute to more than one result. It is also the case that the ordering of the activities is not in complete concordance with the ordering of the results. Again, this is not a serious issue in terms of actual project implementation. In order to accommodate this, each activity has been split into sub-activities and ordered in the Log Frame by Result to which they contribute and within Result, by the order in which they need to be implemented to achieve the Result. These details are shown in the Log Frame in Annex A. This provides an objective monitoring point for project progress. In this section, each Activity is shown as in the ToR (Annex II) with comments on each One general comment that applies to all the activities is that where the Contractor is required to undertake the activity, this will always be in close collaboration with the Beneficiary, the KFVA. The Contractor and their Project Team see this as an important aspect of the project implementation; it is taken as implicit in the Activities in the ToR but the Project Team wishes to state it explicitly at this point in this report. Whilst it is not repeated throughout below, it should be taken as such. COMPONENT 1: Animal disease control Activity 1: The Consultant, together with the Animal Health Department of KFVA, will review the current animal health organisational framework in Kosovo, both at central level and regional level, with a view to proposing a possible streamlining of functions, rationalise of allocation of responsibilities and upgrade organisational network. Additionally, the Consultant will draft multiannual work plan covering all main functions of the animal health sector. The plan will provide for implementation on the basis of annual activities, will provide for regular assessment of results and will foresee changes or fine tuning of the plan during its implementation. Cost-benefit analyses will be mainstreamed within the work plan so as to supply precious indicators for optimal allocation of financial resources. Comments on Activity 1: This activity integrates fully and contributes to Result 1 but also contains elements of Result 3. The Activity is clear. Main-streaming cost-benefit analysis is a significant and important change that will require particular attention. Activity 2: The Consultant will prepare and implement surveillance and vaccination plans for all diseases for which reporting and notification is compulsory (according to EU and OIE procedures). Additionally, surveillance plans will be drafted and implemented also for those diseases for which reporting and notification are not compulsory but for which, on the basis of available epidemiological data, the Consortium Agrotec SpA / NIRAS / IZSVe 12

16 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Consultant, together with KFVA, have identified to be priority diseases for which surveillance is deemed important. Cost-benefit analyses will accompany plans for each disease addressed within the project. Comments on Activity 2: This Activity contributes to Result 2. The potential list of diseases included in this activity is long and a practicable list will need to be produced using risk analysis and priorities. It is unlikely that vaccination programmes will be required or feasible for many diseases beyond the current campaigns which include brucellosis, anthrax, CSF and rabies. A further vaccination programme against clostridial diseases is foreseen for There will be a need for careful prioritisation of diseases for both surveillance and vaccination to meet the resources available to the project and the KFVA. This is also true for the cost-benefit analysis, although this may also be limited by the data available; cost benefit analysis requires an adequate level of reliable data in order to offer a meaningful result. The list of diseases will also be an important element in defining the diseases to be included in Component 2 Laboratory Testing as the major emphasis of this must be to support and strengthen the surveillance required as part of Result 2. Current surveillance is weak, and in particular the primary surveillance carried out by farmers and PVPs who report disease as opposed to the collection of samples, active surveillance. The latter needs strengthening but the former, the most important form of surveillance, seems very weak. Strengthening this will require working with PVPs and farmers to improve their knowledge of what to report and how and their willingness to do so. Activity 3: The Consultant will draft contingency plans and related operational manuals for selected priority animal diseases. The Consultant will also review the national Kosovo legislation in order- to verify and ascertain that actions contained in the contingency plans are covered by legislation in force. Specific legal gap analyses will be prepared should the legislation not be entirely compliant with the needs of emergency actions provided for by the contingency plans. Relevant simulation exercises (desktop and field) will be organised and implemented for the major diseases. Comments on Activity 3: This Activity aligns with Result 4. Currently, no CPs or OMs have been made available to the Project despite requests to see them. It seems that there may as yet be no functional CPs or OMs in Kosovo, although this remains to be verified. They are certainly not easily available. They will probably need to be created from scratch in most if not all cases. There will need to be a realistic assessment of what can be achieved during the project. It is important that the process of reviewing, updating and writing Contingency Plans (CPs) and Operational Manuals (OM) is not undertaken by the project in isolation from KFVA. It would be very easy to take an already produced CP from another country, rename it, change a few words and present it as a CP for Kosovo. But it is important that all CPs are based in local possibilities, Consortium Agrotec SpA / NIRAS / IZSVe 13

17 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- legislation and organisational structures. It is equally important that the KFVA have ownership of the CPs as they are the people who will have to implement them and for whom they should act as a resource designed to work with and in their actual situation. A CP is a guide and assistance at the start of a disease emergency; it must be a help, not a hindrance. This can only be achieved by KFVA staff being a key part of writing the CPs. The same is perhaps even more true of OMs. It will be essential the project guide, facilitate and catalyse but not take over the process. We need to build the capacity to create CPs and OMs, not substitute it. Activity 4: The Consultant will conduct a training needs assessment, and on that basis develop a training programme for the duration of the project. Fulfilment of the training objectives shall be reviewed quarterly and reported to the Contracting Authority as regular part of the project quarterly reports. The training will, among other topics, include collection, processing and analysis of epidemiological data, design and implementation of surveillance plans, and other basic activities needed to ensure an efficient animal disease control. Target trainees should be central level decision makers and field staff Comments on Activity 4: The activity contributes to Result 1. The Activity is clear. Activity 5: An information campaign on Brucellosis and clostridia will be prepared and implemented by the Consultant. A communication strategy will be prepared and submitted for approval to the Beneficiary indicating the target groups to be addressed and the media to be adopted (press, radio, posters, etc.). The campaign will be focused both on informing private individuals on the impact of Brucellosis on human health but will also serve as communication/information for farmers and stakeholders on actions that will be undertaken by KFVA and obtain support. Comments on Activity 5: This Activity contributes to Results 5 and 6. The Activity is clear. Activity 6: Presently adopted control plans for Brucellosis will be reviewed and analysed in detail. Data collected in previous years will be elaborated and analysed in order to prepare an epidemiological study of the disease status in the country. On the basis of such study, a revised version of the control plan will be prepared by the Consultant. The plan will be profiled so as move towards a prospective disease free status. For this goal, the Consultant will focus on the EU and OIE criteria adopted to declaration of Brucellosis disease free status. The revised plan will concentrate also on implementation measures to be adopted at field level so as to ensure that all tasks required are properly and fully implemented. Consortium Agrotec SpA / NIRAS / IZSVe 14

18 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Comment on Activity 6: This Activity contributes to Result 5. The intention to move towards a prospective brucellosis disease free status is clear. To do this would require moving from the current vaccination campaign in small ruminants to a test and slaughter programme for both large and small ruminants. This has several implications that may limit the ability to do this such as a requirement for effective movement controls and the level of sampling and laboratory testing that would be required. The movement controls are perhaps likely to be the harder to implement, but the need to test all ruminants at least once a year and more frequently for herds/flocks with infected animals will also be challenging in the short term. This, plus compensation, will also have strong budgetary implications that will need to be carefully planned. Activity 7: The Consultant will undertake a comprehensive review of existing control plans for clostridial diseases, taking account of the potential costs and benefits that control of these diseases entail for livestock producers and the wider economy. Given the ability of clostridial bacilli and spores to persist indefinitely in the environment, the review will pay particular attention to the long term costs of control and the desirability of ensuring appropriate cost-sharing arrangements between the public and private sectors. The review shall also include an assessment of the laboratory tests and resources (diagnostic kits, biological materials and other consumables) needed to support programmes for the control of brucellosis and clostridial diseases. Comment on Activity 7: The first part of the Activity contributes to Result 2 and the second part to Results 8 and 9.This activity is clear. Activity 8: The Consultant will address the need to raise awareness among farmers and other stakeholders (including private veterinarians) concerning the importance of animal disease control and eradication. For this purpose the contractor will develop and deliver an integrated communications campaign, including themed workshops, printed and internet materials and audio-visual spots for broadcast, which emphasises a partnership approach to the control and eradication of the priority animal diseases selected by the FVA. Comments on Activity 8: This Activity contributes to Result 6. The Activity is clear. The key stage will be to select the diseases to be included. Brucellosis and clostridial diseases are covered in Activity 5. Further priority disease will be selected early on in close collaboration with the KFVA as part of Result 2. Activity 9: The Consultant will review existing arrangements for the implementation and delivery of the massvaccination campaign against brucellosis (begun in 2010). Based on this review and an economic assessment of a range of cost-sharing options (to be agreed during the inception period with the Contracting Authority and Beneficiary Authorities), the contractor will elaborate a multi-annual implementation programme for the mass vaccination of small and large ruminant livestock populations. The contractor shall be responsible for the operational management and delivery of the programme during the lifetime of the project. Consortium Agrotec SpA / NIRAS / IZSVe 15

19 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Comments on Activity 9: This activity contributes to Result 5. The Activity is clear for the most part and will be undertaken in close collaboration with KFVA. However, it is important to clarify the final sentence, The contractor shall be responsible for the operational management and delivery of the programme during the lifetime of the project. This has been discussed with the Beneficiary and the Contracting Authority and it is clear that there is a need to reorient the meaning of the sentence. For the contractor to be responsible for the operational management and delivery of the brucellosis campaign implies taking over this activity from KFVA for the duration of the project and then handing it back two years later. This is technically undesirable as it substitutes rather than builds capacity. This goes against the principles of the project and of sustainability. It is financially not possible as there is no provision for this in the Incidental Expenditures. Even if there were, the level of funds in the Incidental Expenditures adequate to cover this activity and allow for anything else; there would be little or no funds left for any other activity. The responsibility for the operational management and delivery of the brucellosis vaccination campaign will remain with KFVA. The project will work closely with them to monitor the implementation of the vaccination campaign including cold chain at all points along the storage and distribution chain; progress of vaccination in the field on a weekly basis; post vaccination monitoring in vaccinated herds/flocks including a method for independent cross-checking of results; fully random sampling; detailed analysis of results and formulation of amendments to the campaign methodology. Activity 10: The consultant will assist Animal Health department to prepare long term budget requirements for implementation of disease surveillance and control programmes. Comments on Activity 10: This component contributes to Result 1. It will depend on the outcome of Results 1, 2 and 5 and the actions required by these. COMPONENT 2; Laboratory testing Activity 11: The Consultant will conduct a training needs assessment addressed towards strengthening and upgrading laboratory testing activities performed within the veterinary laboratory. The analysis will focus on present animal health testing methods in place and on adoption of ISO quality system. A training program will be prepared and submitted to the Beneficiary for approval and implemented throughout the duration of the project. Project quarterly reports will contain information on the progress of the training plan and on results obtained. Comments on Activity 11: This Activity relates to Results 7 and 10. The activity is clear. It is proposed that specialist training can be achieved by using Incidental Funds for international study visits to send selected staff to an appropriate EU Institute for short term intensive training in specific topics which will be Consortium Agrotec SpA / NIRAS / IZSVe 16

20 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- complimented where required by a specialist from that institute coming to the KFVA for a short period to reinforce and complete the training under local conditions. Activity 12: In order to adequately support the animal health plans elaborated within activities 1, 2, 6 and 7, the Consultant will draw up a list of laboratory testing methods needed to support such plans. The list will revert to the technical features of the laboratory methods suggested by EU Regulations or Directives and by OIE standards for different functions of the plans (testing samples, strain genotyping, verifying vaccination coverage, etc.). Comments on activity 12: This Activity contributes to Result 8 and links with Results 1, 2 and 5 and with Activities 1, 2, 6 and 7 as indicated. The Activity is clear. This clarifies that the activities regarding laboratory testing are strictly subject to the preliminary definition of the list of diseases which are to be taken into account and, for each disease, the list of laboratory procedures which must be in place. Activity 13: The Consultant will check availability of equipment needed for execution of tests listed under Activity 12 and, for missing equipment, will prepare technical specifications drafted in accordance with PRAG requisites. Comments on Activity 13: This activity relates to Result 9 and links with outcome of Result 8. The Activity is clear. Activity 14: Laboratory activity will benefit significantly from revision, streamlining and upgrading of the laboratory management system. The Consultant will draft a proposal for a revised system that will include document management functions, possible IT application and due respect of technical issues required by ISO standard. The system must ensure reliable registration of data and traceability of samples during the testing activities. The system can be designed with a wide range of different functions. In the more sophisticated applications, an IT system, directly interfaced with the analytical testing instruments, could be envisaged. A prior assessment of available budget will be made with a view towards profiling a cost effective system in line with KVFA financial allocation. Comments on Activity 14: This contributes to Result 11. For the most part, the Activity is clear. However, Result 11 indicates that the Laboratory Management System will have been updated during the project. It is clear in Activity 14 that the Project will draft a proposal for the design of system that it is agreed with KFVA should be implemented. But within the Incidental Expenditures, there is no funding available to implement such a proposal; these funds would need to come from the KFVA budget, and the preparation of a budget for this is foreseen in Activity 14 in that the design will be tailored to the available KFVA financial allocation. Consortium Agrotec SpA / NIRAS / IZSVe 17

21 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 3.4 Resources and budget The project has two major resources, the Project Team and Incidental Expenditures Project Team Project staff will continue to work from the office established in Pristina which the consultant has furnished and equipped. Backstopping and support staff (e.g. office manager, translation) will continue to assist project implementation. The Project Team comprises two Key Experts (KE1 and KE2) with a total of 710 working days of inputs, 400 Working Days for Senior Short Term Experts (SSTE) and 1140 days for Junior Short Term Experts (JSTE) The two key experts have a pivotal role in the implementation of the project; they will spend at least 90% of their allocated working days in Kosovo. In accordance with the terms of reference for the project, the profiles of the key experts are as follows. The Team Leader (Key expert 1 estimated input of 410 working days) will be responsible for the overall planning and successful implementation of the project, liaison with the Beneficiary and the Contracting Authority, and for the production and submission of the inception report, progress reports, and final report. The KE1 will also have overall responsibility for Component 1 of the project, Animal Disease Control. An Animal Health Expert (Key expert 2 - estimated input of 300 man/days) will have overall responsibility for Component 2: Laboratory Testing including the tests to be carried out, quality assurance and the laboratory management systems. All of these will be according to EU and OIE requirements and where possible to ISO standards. Senior experts (for a total of 400 working days) will be deployed to support activities related to: disease control; veterinary diagnostics; human resource management and training; livestock economics; veterinary legislation; information technology; communication and media; brucellosis. Junior experts will also be deployed for a total of 1,140 working days in the areas of disease control and surveillance; contingency planning and simulation exercises; livestock economics; communications and media; human resource management and training; legislation An indicative plan for the deployment of personnel has been developed (Annex D); a summary of the inputs by the project s experts is presented in Tables 1 and 3. Several changes have been made to the technical proposal made by the Contractor. These have been based on checking the real requirements of and in close consultation with the Beneficiary, the KFVA and SSTE inputs during the inception phase. The proposed changes have been discussed with and agreed by the Beneficiary and the EUO. The tables below show the posts and distribution of Working Days in the Technical Proposal and currently proposed. The total numbers of days per category and overall remains the same, but the allocation has been altered to meet the current needs of the KFVA and the Project. The Key Expert Days remain as in the ToR and the Technical Proposal i.e. 410 Working Days for KE1 Team leader, and 300 Working Days for KE2 Animal Health Expert. Consortium Agrotec SpA / NIRAS / IZSVe 18

22 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- The SSTE days proposed are shown in Table 1 below Table 1: Indicative reallocation of senior expert inputs for the KAHL Project Senior Short-Term Experts Original proposal Proposed in Inception Report SSTE Disease control expert 0 90 SSTE Veterinary diagnostics SSTE Livestock economics SSTE HR Management & Training SSTE Information technology SSTE Communications & media SSTE Legislation 0 25 SSTE Brucellosis Control Expert 0 20 SSTE Laboratory organisation 40 *0 SSTE Training 73 **0 SSTE totals * To be covered by the KE2 ** Amalgamated with the HR management role Given the strength of the KE2 in laboratory organisation and testing, it has been agreed to decrease the time available for the SSTE Laboratory Diagnostics and to pass all responsibility for the SSTE Laboratory management to the KE2. There is a need to supplement and strengthen the TA team in Disease Control, so an SSTE post in that speciality has been added to the SSTE team. The person appointed will work closely with the KE1 to work on contingency planning, simulation exercises, disease surveillance and postvaccination monitoring. Two other SSTE posts have been added. The first is in legislation as Activity 3 in result 4 requires an assessment of the veterinary legislation. The second is to bring a high-level specialist in brucellosis control for two short missions to focus on and give high level advice on the brucellosis control campaign in Kosovo and strong guidance for the future steps in control and eradication. The SSTE posts in HR management and training have been amalgamated as they are closely related and consultants in one can normally cover the other. Indeed, training assessment and training is an integral part of human resource management. The working days for the Livestock Economist have been increased to allow for a greater range of work and more time to transfer knowledge to Kosovan specialists, strengthening sustainability in this area. Sixty five WDs have been used for the KE and SSTE posts during the Inception Phase and these are shown in Table 2 below. Consortium Agrotec SpA / NIRAS / IZSVe 19

23 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Table 2: KE and SSTE inputs during the Inception Phase Key Experts Post Team Leader 32 Animal health 13 Senior Short Term Experts Information technology 10 Communications 5 Livestock Economics 5 Total Working Days 65 Working Days As for the SSTE posts, reallocation of time for the JSTE posts has been taken after consultation with the Beneficiary and the EUO. The proposed posts and WDs are shown in Table 3 below. Table 3: Indicative reallocation of JSTE inputs to the KAHL project Junior Short-Term Experts Technical proposal Proposed in Inception report JSTE Disease control and surveillance 220 *352 JSTE Contingency plans and simulation exercises JSTE HR management and Training JSTE Communications & media JSTE Legislation JSTE Livestock economics 0 70 JSTE Epidemiologist 155 **0 JSTE Information technology 80 0 JSTE Statistician 70 0 JSTE Farm livestock 90 0 JSTE Finance & procurement 70 0 JSTE Human resources 50 0 JSTE Public health 40 0 JSTE Event logistics expert 40 0 JSTE Unallocated JSTE totals * Converted and expanded to the Disease control and surveillance post ** Selected posts may be reinstated using unallocated working days if it is seen later on in the project that there is a defined need for this expertise Consortium Agrotec SpA / NIRAS / IZSVe 20

24 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- For the JSTE posts, a substantial level of change is recommended. There are two large areas of work for the project. Firstly disease control and surveillance and secondly in the writing of contingency plans and organising simulation exercises. Both require a more constant long term input to ensure that progress is made and maintained. For this reason, it is proposed that for each area there should be a long term near-full time JSTE. The JSTE for disease control and surveillance will be responsible for working with the KFVA to ensure the field implementation of planned disease surveillance activities and testing of samples taken. In particular, the person appointed will follow vaccination against brucellosis closely to ensure real time completion of the planned vaccination and that the post-vaccination sampling is completed and done so to the agreed plan. The JSTE for contingency planning and simulation exercises will work closely with the KFVA on both activities. These cannot and should not be undertaken by the project in isolation from KFVA. It would be very easy to take an already produced CP, rename it and change a few words and present it as a CP for Kosovo. But it is important that all CPs are based in local possibilities, legislation and organisational structures. It is equally important that the KFVA have ownership of the CPs as they are the people who will have to implement them and for whom they should be a resource designed to work with and in their actual situation. That can only be done by KFVA staff being a key part of writing the CPs. The same is perhaps even more true of Operational Manuals. The JSTE will act as a facilitator, encourager and, where required, driver of the work being carried out by KFVA to create CPs and OMs that are matched to the actual situation in Kosovo. A JSTE in Livestock Economics has been added to ensure that the SSTE in Livestock Economics has a counterpart to work with and also passes knowledge to local staff. The proposed JSTE roles in HR and training have been amalgamated as for the SSTE posts in these areas. Several JSTEs roles proposed in the Technical Proposal have been shelved in the proposals in this Inception Report. These are epidemiologist, information technology, statistics, event logistics, public health, and farm livestock. The epidemiologist post has been redefined and expanded to the JSTE Disease control and surveillance post. On discussions with the KFVA, some roles were not felt to be needed including farm livestock and statistics that would be provide through the field experience and expertise of disease control and epidemiology specialists. For others, it was felt that they may or may not be required and this would need to be determined during the implementation of the project. This includes the JSTE Information Technology which has been removed on the advice of the SSTE Information Technology following his scoping mission during the Inception Phase. However, if the need for this post, or others, becomes clear during the implementation phase, it could be reinstated. For this reason, 186 days of JSTE time have been left as unallocated so that they can be used as and when necessary including for these possible roles Incidental Expenditures The Incidental Expenditures are set at 200,000. The permitted uses are detailed in the Project ToR (Annex II) and are Consortium Agrotec SpA / NIRAS / IZSVe 21

25 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 1) Workshops, trainings, seminars on laboratory techniques, epidemiological investigations, disease identification and reporting, sample collection, recording and packaging etc.; 2) Study visits to the counterpart institutions in the EU member states, with the principle subjects of study tours being animal health planning and reporting, disease control and eradication measures for specific diseases such as tuberculosis and brucellosis, laboratory management including quality control and proficiency testing 3) Surveillance and testing programme, among other shall cover implementation of biannual surveillance programme for Brucellosis, Tuberculosis, BVD, IBRD, CSF, BT ( Bluetongue), African Swine Fever, HPAI etc.. 4) Travel within country to cover the cost of transport for the workshops, seminars, sample collection, dispatch of sampling material etc.. 5) Public Information campaigns targeting farmers and other stakeholders on the need to report suspected outbreaks of diseases at the farm level, slaughterhouses, livestock market and transport. Table 4 shows an indicative breakdown of the use of the Incidental Expenditures by category and project year (PY) Table 4: Disbursement plan for Incidental Expenditure (IE) for the period of the project (PY1 and PY2) Item PY1 PY2 Total % of Total Indicative Incidental Expenditure Training 13,000 6,400 19, Study visits 26,000 12,000 38, Surveillance and testing 32,260 34,030 66, Travel and per diem 18,150 15,610 33, Public information campaign 24,018 16,012 40, Allocated totals 113,428 84, , Contingency 2, Overall total 200, A more detailed breakdown is given in Annex E. The majority of the Travel and Per Diem budget line is to support the surveillance and testing programme with travel also required for the public information campaign and the livestock economics activities. Very little of this line is set aside for per diems as it anticipated that the majority of field trips can be completed in a day. Consortium Agrotec SpA / NIRAS / IZSVe 22

26 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- For the item on study visits, two distinct activities are proposed 1) A study tour by a group of veterinarians from the Directorate of Animal Health and Welfare of the KFVA to an EU MS or EU region with similar circumstances to Kosovo in terms of size, border issues and disease situation but where a fully functioning veterinary service is in operation to EU standards. This study tour should take place as early as possible in the project to allow time for the lessons learned and information gained to be applied during the lifetime of the project. 2) A series of short study visits by laboratory staff of the KFVA Food and Veterinary laboratory (and specifically the Animal Health lab) to ISO17025 certified diagnostic laboratories in the EU in order to learn specific methods for disease diagnosis or lab management. These would then be complemented by a return visit by a specialist from that EU lab to the KFVA laboratory in order to reinforce and complete the training under local conditions. These latter visits would be under the SSTE post for Veterinary Diagnostics. There is no defined government contribution to the project in financial terms. However, the close collaboration with KFVA staff that has been present to date and is expected to continue forms a valuable and essential contribution by the RKS government to the project. 3.5 Assumptions and risks The assumptions and risks have been reviewed and are included as Annex F. There are none that seem at this early stage to be critical to the implementation if the project. However, they will be kept under frequent review. The table of identified risks also include their estimated probability, impact and proposed mitigation measures. 3.6 Management and coordination arrangements The arrangements for the management and coordination of the project are described in the project s terms of reference and the technical proposal. They are outlined schematically in Figure 1. The European Union Office in Pristina, represented by the Task Manager, is responsible for the management of the service contract with the consultant. Project implementation will be guided by a Project Steering Committee (PSC) comprising major stakeholders such as the KFVA, MAFRD and possibly representatives of other stakeholder groups. The ToR of the project (Annex II) states that meetings of the PSC will be convened at least every 3 months to discuss the progress of the project (the project shall send electronically to any member of the PSC the content of the meeting along with a summary of the progress achieved by the project). The Task Manager approves the engagement of all non-key experts and the incidental expenditure for study visits and other training outside Kosovo. The structure of the project and its organization are shown in Figure 1. Consortium Agrotec SpA / NIRAS / IZSVe 23

27 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Figure 1: KAHL Project management and co-ordination structure As well as the formal guidance of the PSC, it is proposed to establish a technical working group (WG) composed of KAHL specialists, KFVA staff, MAFRD Livestock specialists, PVP representatives and representatives of active producers groups. This WG would meet regularly, probably quarterly, to allow an exchange of information and ideas that would be beneficial to both the Project and the KFVA. Other WGs might be considered, although probably with KAHL acting as catalyst rather than directly organising them. These could include a WG on livestock economics, drawing membership from KFVA, the University of Pristina, other universities/colleges and specialists from NGOs a WG on laboratory diagnostic methods and quality control with membership from the KFVA laboratories, the NIPH and other human diagnostic laboratories. The project started with the arrival of the Team Leader on 23 February By March 2015, the Consultant had established an office in premises located near to the EUO. It is hoped that a satellite office can be established at KFVA. 3.7 Financing arrangements The project is financed by the European Union. The EU has allocated Euro 200,000 to meet incidental expenditure associated with the implementation of project activities, the disbursement of which will be in accordance with the indicative budget included in this Inception Report (Annex E Consortium Agrotec SpA / NIRAS / IZSVe 24

28 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- and as shown in summary above in Table 4). Prior approval via administrative orders issued by the EU Office is required for the expenditure for study visits and the utilization of this provision will be authorized by the Task Manager. Other Incidental Expenditure funds can be used without prior approval of the EUO Task Manager. However, it will be an important and sensible action to keep the EUO Task Manager informed of the proposed use of all Incidental Funds to ensure that this is done in compliance with EU procedures. Funds will be advanced to the project by the Consultant who will claim reimbursement through invoices submitted with each interim report. In addition, the EU has potentially allocated a budget of Euro 300,000 for laboratory equipment required for project implementation, which will be procured through an international supply tender. However, this is completely separate from project funds. 3.8 Monitoring, review and evaluation arrangements The project team will monitor implementation in a participatory style, which will provide the opportunity for project partners to contribute to action planning. In this manner, operations will be jointly planned, implemented, monitored and reviewed. The basis for evaluation will be provided by a framework linked to the impact indicators, assumptions and preconditions that are included in the logical framework included as Annex A. This Log Frame is the key tool for M&E of the project. Linked to this is the table of Deliverables by Result and Activity (Annex B) and the Indicative Timetable of Activities in Annex C which shows the expected times of implementation for each subactivity and the expected timing of the deliverable from each. These three documents work together to provide a dynamic system for monitoring and evaluating the project on a frequent basis by the project and the EUO. 3.9 Key Quality/Sustainability issues Lessons from previous projects show clearly the need for the implementation of the KAHL Project to start by establishing and maintaining close working relationships with the KFVA in order to achieve a sustainable outcome. To establish adequate ownership and promote the development of the beneficiary s capacity, the project will aim to secure a high level of participation of key actors by creating a range of opportunities for them to assist in project planning, implementation and monitoring. The project will provide a high level of technical support but will avoid when at all possible any substitution for local project partners in the state veterinary service or private veterinary practice. Wherever possible, the partner institutions will be responsible for the implementation of activities that they will have to continue after the project, for example, in conducting vaccination campaigns, in monitoring the performance of field veterinarians (under guidance of the project), in disease reporting and in organizing controls of animal movement. The project will seek to build any new procedures into the standard operating systems of the beneficiary so that they continue after the end of the project. Attention to these factors is expected to assure the quality of the project s actions and enhance the sustainability of its intended impact. Consortium Agrotec SpA / NIRAS / IZSVe 25

29 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 4 WORKPLAN FOR THE NEXT PERIOD (ANNUAL PLAN) This is a two year project so, by definition, any planned activity, deliverable of input not achieved in PY1, will need to be achieved in PY2. For this reason, all of the following sections cover both PY1 and PY Results to be delivered The results to be delivered are detailed in the List of Deliverables and sub-activities in Annex B and shown on the indicative Timetable of Activities Annex C. Each deliverable is a milestone per se so no additional milestones are indicated. 4.2 Activity schedule The indicative timetable of activities is shown in Annex C. The activities and sub-activities are shown by result and deliverable, with the end point of each activity and sub-activity being one or more deliverables which are mostly reports that will detail what has been done and the result. 4.3 Resource schedule and budget The indicative deployment for project personnel for PY1 is shown in Annex D and the indicative budget for PY1 is shown in Annex E. 4.4 Monitoring and Evaluation Monitoring and evaluation of project progress will be made using the following key tools and indicators The OVIs in the LogFrame attached as Annex A The achievement of deliverables as shown in the Timetable of Activities and Deliverables attached as Annex B The details of the Deliverables for each sub-activity attached as Annex C The use of Project personnel Working Days, shown indicatively in Annex D The use of Incidental Expenditures, shown indicatively in Annex E In each report, the achievements of outputs and use of resources will be compared against the plan for that period as shown in this Inception Report for AWP1 and for AWP2 for PY2. Where target shave not been met, the reason(s) for this will be documents and the corrective measures required formulated and instituted. 4.5 Updated risk management plan The risk management plan is shown in Annex F and is the same ad referred to in section Special activities to support sustainability The approach to sustainability for this AWP is outlined in Section 3.9 above. Consortium Agrotec SpA / NIRAS / IZSVe 26

30 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- 5 ANNEXES Annex A Annex B Annex C Annex D Annex E Annex F Annex G Annex H Annex I Annex J Updated LogFrame Deliverables and sub-activities Indicative Timetable of Activities including Deliverables for PY1 and PY2 Indicative Personnel Deployment for PY1 and PY2 Indicative Incidental Expenditures Budget for PY1 and PY2 Assumptions and Risks including Risk Management Plan Report of the KE2 Animal Health Report of the SSTE Information Technology Report of the SSTE Communication and Media Report of the SSTE Livestock Economics Consortium Agrotec SpA / NIRAS / IZSVe 27

31 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex A LogFrame Consortium Agrotec SpA / NIRAS / IZSVe 28

32

33 KAHL Project Inception Report LogFrame Project Description Indicators Sources of information Assumptions Overall Objective The overall objective of the project is to strengthen safeguarding measures of animal health from the introduction of so-called exotic diseases and to reinforce the capacity to implement control and eradication plans for diseases present in the country. This essentially means the introduction of improved strategies for the surveillance and control of the targeted diseases and, if appropriate and achievable, for their eradication. In order to ensure the effective implementation of the new measures, capacity building in the official veterinary service is also necessary. - Revised Work Plans for livestock disease surveillance, control and eradication are in place and being implemented. -Epidemiological data show reductions in the prevalence of the targeted diseases. - The prevalence of zoonotic diseases in the human population has fallen. - Documented work plans - Official statistical reports of cases and outbreaks of livestock diseases -Public health disease reports - That the official veterinary service (KFVA) approve, accept and implement the revised disease control strategies. - That the human, financial and other resources necessary for the implementation of the measures are, and continue to be available. - That the human, financial and other resources necessary for the implementation of the measures are, and continue to be available. Project Purpose 1. To ensure a high level of public health and food safety by minimising the incidence of biological and chemical risks to humans. Reduced prevalence of foodborne and other zoonotic diseases. Official public health records and reports In addition to animal health controls, there is an understanding and acceptance of the risk of contact with infected animals and of the care needed in the production and preparation of food of animal origin. 2. To promote animal health by preventing/reducing the incidence of animal diseases, and in this way to support farming and the rural economy. Government (MAFRD) data show improvements in rural income. Kosovo statistical reports indicate less dependence of the country on imported food of animal origin. The public awareness campaigns for farmers have their intended effect. 3. To improve economic growth, cohesion and competitiveness and to ensure safety in the free circulation of goods and proportionate animal movements. 4. To promote farming practices and animal welfare which prevent animal health related threats and minimise environmental impacts in support of the EU Sustainable Development Strategy. Increase in the income of livestock farmers. Animal production methods, attention to health and welfare and marketing improve. Official statistical reports of agricultural GDP The productivity and profitability of livestock farming will improve. That planned improvement in the provision of advisory inputs in agriculture have the desired effect. EC progress Reports on Kosovo Farmers adopt new ideas and combine with neighbours and commodity groups to achieve improvements.

34 KAHL Project Inception Report LogFrame Project Description Indicators Sources of information Assumptions Project Results R1. A development plan for the Animal Health Unit, including annual and multiannual work plans have been prepared. The restructuring of the Unit is complete and documented. The work plans exist in document form and are being implemented. Project Quarterly Reports. KFVA annual reports and annual plans KFVA approves the development plan and the work plans. Veterinary field staff perceive the benefits of the revised plans and implement them conscientiously. R2. Surveillance and vaccination programmes for diseases identified by the KFVA and those for which reporting is compulsory have been drafted and implemented. The programmes are in place and being implemented: records of vaccinations and laboratory results of surveillance are available. Project Quarterly Reports. KFVA reports of surveillance results and vaccination campaigns The human and other resources are adequate for the implementation of the programmes. R3. A cost benefit analysis for the control and/or eradication of selected animal diseases has been prepared.. A report of the analysis is available Project Quarterly Reports. Official MAFRD/KFVA reports The analyses will be used objectively by decision makers to decide on the priorities for disease control activities. R4. Contingency plans for selected animal diseases have been reviewed and updated. R5. The control plan for brucellosis and clostridial diseases has been reviewed and updated. A list of diagnostic kits, biological materials and other consumables needed for implementation of the programme for control of brucellosis and clostridial diseases has been drafted; laboratory capacities and the potential inclusion of new tests and techniques have been reviewed and updated. The revised contingency plans are available in printed and electronic form The revised control plans are available in printed and electronic form. The revised test manual is available in printed and electronic form Project Quarterly Reports. Official MAFRD/KFVA reports Project Quarterly Reports. Official MAFRD/KFVA reports KFVA adopts the plans, takes steps to make them legally binding and puts them into effect. Government funding is sufficient to maintain the required supply of the necessary diagnostic kits, biological materials and other consumables for the field work and laboratory testing R6. An awareness campaign for farmers and other stakeholders concerned on the importance of disease control and eradication has been designed and implemented. The awareness materials are available Project Quarterly Reports. The stakeholders have access to the awareness materials and that they make a point of becoming familiar with the issues involved. The target audience understands and accepts the information presented

35 R7. A training needs analysis has been carried out and training for the laboratory staff has been delivered. KAHL Project Inception Report LogFrame Project Description Indicators Sources of information Assumptions Both the analysis and the Project Quarterly Reports. training materials are available. Signed training attendance forms and training evaluation forms are available The staff participate actively in the training sessions and that they provide practical feed-back.. The revised test manual is available in printed and electronic form. R8. A list of tests and analysis to be included in the range of laboratory services to be performed has been drafted. The list is readily available. Laboratory SOPs are available. Project Quarterly Reports The revised test manual is available in printed and electronic form. R.9 A list of missing equipment and technical specifications for that equipment has been prepared. The list is readily available. Project Quarterly Reports. Procurement documentation Staff co-operate in the preparation of the list of missing equipment. R10. Laboratory staff have been trained and are capable of performing the laboratory tests for the selected animal diseases The training materials are available. Training evaluation completed Project Quarterly Reports Staff accept the revised test manual and adhere strictly to the protocols set out. R11. The laboratory management system, including document management and the communication system have been reviewed and updated The proposed revised management system is documented. Project Quarterly Reports. Laboratory documentation Staff contribute ideas to the updating of the laboratory management system, accept the result and adapt quickly to the new arrangements. KFVA has the budget for thw creation and implementation of the system

36 R1 D1.1 D1.2 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions Component 1: Animal disease control Development plan for the animal health unit, including annual and multiannual work plan is prepared A1.1 Together with the Animal Health Department of Head of Animal Health and Study tour to an EU MS or Availability in English of all KFVA, review the current animal health Welfare Directorate region with comparable size necessary information organisational framework in Kosovo, both at KE1 and disease situation central level and regional level, with a view to SSTE HR and Training Travel to field proposing a possible streamlining of functions, SSTE Disease Control rationalise of allocation of responsibilities and JSTE HR and Training upgrade organisational network. JSTE Disease Control D1.3 A1.2 Draft a multiannual work plan covering all main functions of the animal health sector. The plan will provide for implementation on the basis of annual activities, will provide for regular assessment of results and will foresee changes or fine tuning of the plan during its implementation. Cost-benefit analyses will be mainstreamed within the workplan so as to supply precious indicators for optimal allocation of financial resources. Head of Animal Health and Welfare Directorate Head of KFVA An Hlth lab KE1 KE2 SSTE Disease Control SSTE Livestock Econ JSTE Disease Control JSTE Livestock Econ Workshops to train PVPs in disease surveillance and reporting Adequate information on disease incidence, costs of disease and costs of control are available for setting priorities, planning and cost-benefit analysis. Agreement to adoption of the proposed workplan by KFVA and other central decision makers. D1.4 A4.1 Conduct a training needs assessment, and on that basis develop a training programme for the duration of the project. The training will, among other topics, include collection, processing and analysis of epidemiological data, design and implementation of surveillance plans, and other basic activities needed to ensure an efficient animal disease control. Target trainees should be central level decision makers, field staff and PVPs SSTE HR and Training KE1 SSTE Disease Control JSTE HR and Training JSTE Disease Control JSTE CP and Simulation High level of response to the training needs assessments Support for training from KFVA Participation by central decisions makers, field staff and PVPs is supported by central authorities

37 D1.5 D1.6 D1.7 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions Travel to training sites Training materials and equipment A4.2 Organise and deliver the agreed training programme. Fulfilment of the training objectives shall be reviewed quarterly and reported to the SSTE HR and Training KE1 SSTE Disease Control Contracting Authority as regular part of the project JSTE HR and Training quarterly reports. JSTE Disease Control JSTE CP and Simulation Suitable venues are available Committed participation by trainees Good level and standard of completion of training evaluations D1.8 A10.1 From a cumulative list of all surveillance and control programs, the cost of each programme will be calculated and will include at least: the cost of vaccines and consumables; staff costs including salaries and physical resources; payments to authorised PVPs; laboratory costs; administrative costs. From this costing data, a detailed long term budget will be prepared SSTE Livestock Econ SSTE Disease control KE1 JSTE Livestock Econ JSTE Disease control JSTE CP and simulation Sufficient data is available to allow a cost-benefit analysis to be carried out R2 D2.1 D2.2 D2.3 Surveillance and vaccination programme for diseases identified by the KFVA and those for which reporting is compulsory have been drafted and A2.1 Prepare and implement surveillance and vaccination plans for all diseases for which reporting and notification is compulsory (according to EU and OIE procedures). KFVA An Hlth Welf Dir KE1 KE2 SSTE Disease control SSTE Vet diagnostics SSTE Brucellosis JSTE Disease control JSTE CP and simulation Field travel for project staff Consumables for taking of samples, dispatch and testing Veterinary information system for collating and analysing data Workshops and seminars on disease surveillance for PVPs and Inspectors KFVA and other decision makers accept the plans PVPs co-operate with the plans Adequate govt. staff and resources are available to implement the plans

38 D2.4 D2.5 D2.6 A2.2 Prepare and implement surveillance plans for those diseases for which reporting and notification are not compulsory but for which, on the basis of available epidemiological data, the Consultant, together with KFVA, have identified to be priority diseases for which surveillance is deemed important. KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions KFVA An Hlth Welf Dir KE1 KE2 SSTE Disease control SSTE Vet diagnostics JSTE Disease control JSTE CP and simulation Field travel for project staff Consumables for taking of samples, dispatch and testing Veterinary information system for collating and analysing data Workshops and seminars on disease surveillance for PVPs and Inspectors KFVA and other decision makers accept the plans PVPs co-operate with the plans Adequate govt. staff and resources are available to implement the plans R3 Cost benefit analysis for control and/or eradication of selected animal diseases is prepared D3.1 A2.3 In collaboration with KFVA, prepare cost-benefit analyses to accompany the surveillance and control plans for each disease addressed within the project. SSTE Livestock Econ JSTE Livestock Econ Field trips to meet with farmers and PVPs R4 Contingency plans for selected animal diseases have been reviewed and updated D4.1 A3.1 Review the current contingency plans for selected SSTE Disease control diseases KE1 JSTE CP and simulation D4.2 A3.2 Draft contingency plans and related operational KFVA AHWD manuals for selected priority animal diseases. SSTE Disease control KE1 JSTE CP and simulation D4.3 D4.4 D4.5 D4.6 A3.3 Review the Kosovo legislation in order to verify and ascertain that actions contained in the contingency plans are covered by legislation in force. Specific legal gap analyses will be prepared should the legislation not be entirely compliant with the needs of emergency actions provided for by the contingency plans. KFVA AHWD SSTE Legislation SSTE Disease control KE1 JSTE Legislation JSTE CP and simulation Realistic disease list has been prepared and accepted Necessary data is available to carry out meaningful CBAs Previous CPs are available for review in translation KFVA establish CP and SOP drafting working group Legislation including administrative orders is available in English

39 D4.4 D4.5 D4.6 D4.7 A3.4 In close collaboration with the KFVA, organise and implement relevant simulation exercises (desktop and field) for the major diseases. KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions KFVA AHWD SSTE Disease control KE1 JSTE CP and simulation Travel for project staff Hiring of venues Workshops to explain exercises Resources for the organisation and running of simulation exercises (desktop and field) Suitable venues are available KFVA, PVPs and farmers engage fully and participate in the exercises R5 Control plan for brucellosis and clostridial diseases have been reviewed and updated. A list of needed diagnostic kits, biological materials and other consumables needed for implementation of the programme for control of brucellosis and clostridial diseases has been drafted; laboratory capacities and potential inclusion of new tests and techniques have been reviewed and updated. D5.1 A6.1 Collect and analyse the data on brucellosis collected in previous years in order to prepare an epidemiological study of the brucellosis disease situation in the country. D5.2 A6.2 Review and analyse the currently adopted control plans for Brucellosis in detail. D5.3 A9.1 Review the existing arrangements for the implementation and delivery of the vaccination campaign against brucellosis that commenced in 2010 D5.4 A6.3 Assess the laboratory tests and resources (diagnostic kits, biological materials and other consumables) needed to support programmes for the control of brucellosis and identify gaps and requirements KFVA AHWD KE1 SSTE Disease control JSTE Disease control KFVA AHWD KE1 SSTE Disease control JSTE Disease control KFVA AHWD KE1 SSTE Brucellosis SSTE Disease control JSTE Disease control Head of animal hlth lab KE2 SSTE Vet diagnostics SSTE Brucellosis Consumables for seroprevalence study Field travel Field travel to interview farmers and PVPs Field travel to interview farmers and PVPs Data is available to allow a sufficiently detailed epidemiological study Collaboration by farmers and PVPs Information required is available in English KFVA can provide the required information

40 D5.5 A9.4 In close collaboration with KFVA, undertake the assessment of the operational management and delivery of the programme during the lifetime of the project. Monitor the distribution of vaccine, the maintenance of the cold chain and the field application of the vaccine. Design the postvaccination sero-monitoring and monitor its application and results. KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions KFVA AHWD Field travel for monitoring by SSTE Disease Control project of vaccination KE1 Consumables for sample KE2 taking SSTE Vet diagnostics Cold chain monitoring JSTE Disease control equipment The cold chain is properly monitored PVPs take post vaccination samples as required Farmers, PVPs, inspectors and KFVA staff co-operate fully D5.6 A9.3 Elaborate a multi-annual implementation programme for the vaccination of small and large ruminant livestock populations against brucellosis. D5.7 A6.4 On the basis of the analyses in A6.1 and 6.2, a revised version of the control plan for brucellosis will be prepared. Where possible, the plan will be profiled so as move towards a prospective disease free status. For this goal, the review will focus on the EU and OIE criteria adopted for declaration of Brucellosis disease free status. The revised plan will concentrate also on implementation measures to be adopted at field level so as to ensure that all tasks required are properly and fully implemented. KFVA AHWD SSTE Brucellosis SSTE Disease control KE1 JSTE Disease control KFVA AHWD SSTE Brucellosis SSTE Disease control KE1 JSTE Disease control Collaboration of KFVA staff Programme is accepted by KFVA The revised control plan is accepted and approved by the KFVA, the PSC and the EUO The conditions exist in Kosovo for moving towards a disease free status D5.8 A9.2 Undertake an economic assessment of a range of cost-sharing options for the vaccination campaign against brucellosis (to be agreed during the inception period with the Contracting Authority and Beneficiary Authorities). KFVA AHWD SSTE Livestock Econ SSTE Disease control KE1 JSTE Disease control Field travel to interview farmers and PVPs The required economic data is available The principle of cost-sharing is accepted

41 D5.9 A7.1 Gather the data, information and materials available on clostridial diseases in Kosovo. Undertake a comprehensive review of existing control plans for clostridial diseases. The review shall also include an estimate of the effectiveness and costs (public and private) of the current measures D5.10 A7.2 Taking account of the potential costs and benefits that control of clostridial diseases entail for livestock producers and the wider economy and given the ability of clostridial bacilli and spores to persist indefinitely in the environment, undertake a review of the cost-benefits of their control paying particular attention to the long term costs of control and the desirability of ensuring appropriate cost-sharing arrangements between the public and private sectors. D5.11 A7.3 Assess the laboratory tests and resources (diagnostic kits, biological materials and other consumables) needed to support programmes for the control of clostridial diseases and identify gaps and requirements KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions KFVA AHDW and Labs Field travel to interview PVPs KE1 and farmers SSTE Disease control SSTE Livestock Econ JSTE Disease control JSTE Livestock Econ SSTE Livestock Econ SSTE Disease Control KE1 JSTE Livestock Econ JSTE Disease control Head of animal hlth lab KE2 SSTE Vet diagnostics Field travel to interview PVPs and farmers Adequate data is available to asses the impact of clostridial diseases, costs and benefits of control Adequate data is available to asses the impact of clostridial diseases, costs and benefits of control D5.12 A5.1 A communication strategy for the delivery of information on brucellosis and clostridial diseases, in Albanian and Serbian, with reference to the particular groups to be targeted, the media to be employed (press, radio, posters etc.) and the timing of the campaign will be prepared and submitted for approval to the KFVA with amendments made as required. Head of KFVA Comms SSTE Communication JSTE Communication Previous communications strategies and examples KFVA approves the strategy selected

42 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions D5.13 A5.2 Prepare and trial information campaign materials Head of KFVA Comms Field travel to hold meetings on Brucellosis and clostridial diseases that will SSTE Communication with PVPs and farmers to trial include: the nature of the diseases; the economic SSTE Disease control materials losses to livestock farmers that result from KE1 infections; the risks to human health of brucellosis; JSTE Communication the means by which animal and human infection JSTE Disease control can be prevented; the official measures that are in place or that will be introduced to control and prevent those diseases. The campaign will be focused both on informing private individuals on the impact of Brucellosis on human health but will also serve as communication/information for farmers and stakeholders on actions that will be undertaken by KFVA and obtain support. EU visibility rules will be taken into account in the drafting of the awareness campaign D5.14 A5.3 Implementation of the information campaign on brucellosis and clostridial diseases as planned and assessment of its effectiveness. Feedback on the campaign strategy will be collected and analysed KFVA SSTE Communications SSTE Disease control KE1 JSTE Communications JSTE Disease control JSTE CP and simulation Workshops for farmers, PVPs and Inspectors Resources to produce agreed materials and other media Interest of the target groups in the information presented and their positive response R6 An awareness campaign on the importance of disease control and eradication for farmers and other stakeholders concerned has been designed and implemented D6.1 A8.1 Diseases for the awareness campaign are selected by Project team and KFVA Head of KFVA AHWD KE1 SSTE Disease control JSTE Disease control

43 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions D6.2 A8.2 A communication strategy for the delivery of Head of KFVA Comms Previous communications KFVA approves the strategy information on the selected diseases, in Albanian SSTE Communication strategies and examples selected and Serbian, with reference to the particular JSTE Communication groups to be targeted, the media to be employed (press, radio, posters etc.) and the timing of the campaign will be prepared and submitted for approval to the KFVA with amendments mad as required. D6.3 A8.3 Prepare and trial information campaign materials on selected diseases that will include: the nature of the diseases; the economic losses to livestock farmers that result from infections; the risks to human health of the selected diseases; the means by which animal and human infection can be prevented; the official measures that are in place or that will be introduced to control and prevent those diseases. The campaign will be focused both on informing private individuals on the impact of Brucellosis on human health but will also serve as communication/information for farmers and stakeholders on actions that will be undertaken by KFVA and obtain support. EU visibility rules will be taken into account in the drafting of the awareness campaign Head of KFVA Comms SSTE Communication SSTE Disease control KE1 JSTE Communication JSTE Disease control Field travel to hold meetings with PVPs and farmers to trial materials D6.4 A8.4 Implementation of the information campaign on selected diseases as planned and assessment of its effectiveness. Feedback on the campaign strategy will be collected and analysed KFVA SSTE Communications SSTE Disease control KE1 JSTE Communications JSTE Disease control JSTE CP and simulation Workshops for farmers, PVPs and Inspectors Resources to produce agreed materials and other media Interest of the target groups in the information presented and their positive response

44 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions Component 2: Laboratory Testing R7 Training need analysis and training for the laboratory staff has been carried out D7.1 A11.1 Conduct a training needs assessment addressed towards strengthening and upgrading laboratory Head of KFVA An Hlth Lab SSTE HR and Training High level of practical responses to the TNAs testing activities performed within the veterinary KE2 laboratory. The analysis will focus on present animal health testing methods in place and on SSTE Vet Diagnostics JSTE HR and Training adoption of ISO quality system. D7.2 A11.2 Based on the training needs assessment in Deliverable 7.1, prepare a training programme will be submitted to the beneficiary for approval D7.3 A11.3 Prepare the training materials for the approved training programme for staff of the KFVA Food and Veterinary Laboratory testing for livestock diseases Head of KFVA An Hlth Lab SSTE HR and Training KE2 SSTE Vet Diagnostics JSTE HR and Training Head of KFVA An Hlth Lab SSTE HR and Training KE2 SSTE Vet Diagnostics JSTE HR and Training Training materials Training programme is agreed by KFVA Appropriate resources are available D7.4 A11.4 Implement the training program in Deliverable 7.2 including collecting training evaluation forms. D7.5 A11.5 Produce updates of progress of the training programme and results obtained Head of KFVA An Hlth Lab SSTE HR and Training KE2 SSTE Vet Diagnostics JSTE HR and Training Head of KFVA An Hlth Lab SSTE HR and Training KE2 SSTE Vet Diagnostics JSTE HR and Training Short study missions to EU lab institutes for specified laboratory methods Training materials and equipment Training evaluation system Details of training contents Training attendance record Training evaluation forms Avilability of suitable institutes and venues Appropriate staff are available for training Full participation by selected staff in the training Training evaluations are completed fully

45 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions R10 Laboratory staff trained and capable of performing laboratory tests on the selected animal diseases D10.1 A11.5 Produce updates of progress of the training programme and results obtained SSTE HR and Training JSTE HR and Training Details of training contents Training attendance record Training evaluation forms R8 A list of test and analysis to be included in the range of laboratory services to be performed has been drafted D8.1 A12.1 In collaboration with KFVA, produce a list of the Head of Animal Hlth Lab livestock diseases to be covered by the KFVA Food KE2 and veterinary Laboratory to include notifiable SSTE Vet Diagnostics diseases and non-notifiable diseases included in Key Results 2 (notifiable and non-notifiable diseases) and 5 (brucellosis and clostridial diseases). D8.2 A12.2 Define the laboratory testing methods required for Head of Animal Hlth Lab diagnosis/detection of the diseases in the list in KE2 Deliverable 8.1 and necessary to support the SSTE Vet Diagnostics planned measures for surveillance and control of each of the diseases. The measures may include, where appropriate, testing samples, strain genotyping, verifying vaccination coverage. The selected methods should be in accordance with EU Regulations or Directives and OIE standards Training evaluations are completed fully List is approved by KFVA senior management Collaboration between AHWD Directorate and KFVA Lab D8.3 A12.3 Make a list of the consumables (test kits, reagents etc.) necessary for carrying out the testing procedures included in Deliverable 8.2 with an indication of probable annual throughput for each procedure Head of Animal Hlth Lab KE2 SSTE Vet Diagnostics

46 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions R9 D9.1 A list of missing equipment and technical specifications for these equipment has been prepared A13.1 From Deliverable 8.2, prepare a list of equipment Head of KFVA An Hlth Lab required to carry out the defined tests KE2 SSTE Vet Diagnostics D9.2 A13.2 With the participation and support of KFVA Food and veterinary Laboratory staff, evaluate the availability and functionality of the equipment present in the laboratory and compare this to the list in Deliverable 9.1 to determine what equipment is present and functional, present and requires repair or must be procured in order to meet the tests include in Deliverable 8.2 Head of KFVA An Hlth Lab KE2 SSTE Vet Diagnostics D9.3 A13.3 Prepare a list, including full technical specifications, of equipment to be procured for the KVFA Food and veterinary Laboratory in order to meet the test requirements in Deliverable 8.2 The list and technical specifications will be in accordance with EU PRAG rules and will include an estimate of likely overall cost. Head of KFVA An Hlth Lab KE2 SSTE Vet Diagnostics

47 R11 D11.1 D11.2 KAHL Project Inception Report LogFrame Activity Responsible Other Inputs Assumptions Laboratory management systems including document management and communications system have been reviewed and updated A14.1 Assess the current status of the management SSTE Information Tech Co-operation and support of the systems of Food and Veterinary Laboratory. On KE2 staff of the KFVA food and the basis of this, draft a proposal for a revised SSTE Vet diagnostics veterinary laboratory system that will include document management Acceptance and approval of the functions, possible IT application and due respect proposal by senior management of technical issues required by ISO standard. of KFVA The system must ensure reliable registration of data and traceability of samples during the testing activities. The system, which is aimed at streamlining and upgrading of the laboratory management system, will ensure reliable registration of data and traceability of samples during the testing activities. The system can be designed with a wide range of different functions. In the more sophisticated applications, an IT system, directly interfaced with the analytical testing instruments, could be envisaged. D11.3 A14.2 Make a prior assessment of available budget with a view towards profiling a cost effective laboratory management system in line with KVFA financial allocation SSTE Information Tech KE2 SSTE Vet diagnostics Data is available on costs and quantities in order to create a budget KFVA staff collaborate in the exercise

48

49 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex B Deliverables and Sub-Activities by Result Consortium Agrotec SpA / NIRAS / IZSVe 29

50

51 Deliverable Activity Component 1: Animal disease control Key Result 1 Development plan for the animal health unit, including annual and multiannual work plan is prepared Deliverable 1.1 Detailed assessment of the structure, functions and management of the Animal Health Department A1.1 Together with the Animal Health Department of KFVA, review the current animal health organisational framework in Kosovo, both at central level and regional level, with a view to proposing a possible streamlining of functions, rationalise of allocation of responsibilities and upgrade organisational network. Deliverable 1.2 A detailed proposal for the reform of the structure, management and job allocation of the AHWD Deliverable 1.3 A functional and implemented multiannual workplan with amendments made during the course of the project depending on the results of the monitoring process A1.1 A1.2 Draft a multiannual work plan covering all main functions of the animal health sector. The plan will provide for implementation on the basis of annual activities, will provide for regular assessment of results and will foresee changes or fine tuning of the plan during its implementation. Cost-benefit analyses will be mainstreamed within the workplan so as to supply precious indicators for optimal allocation of financial resources. Deliverable 1.4 A training programme document describing, in details, the content of the programme, the number and approximate timing of the training events and the proposed manner of its delivery A4.1 Conduct a training needs assessment, and on that basis develop a training programme for the duration of the project. The training will, among other topics, include collection, processing and analysis of epidemiological data, design and implementation of surveillance plans, and other basic activities needed to ensure an efficient animal disease control. Target trainees should be central level decision makers, field staff and PVPs Deliverable 1.5 Training materials for the participants produced A4.2 Organise and deliver the agreed training programme. Fulfilment of the training objectives shall be reviewed quarterly and reported to the Contracting Authority as regular part of the project quarterly reports. Deliverable 1.6 Returned training forms and analysis A4.2

52 Deliverable 1.7 Reports on the implementation of the training programme, its efficacy, any changes made as it progresses and suggestions for improvement (QR) Deliverable 1.8 A detailed long term budget prepared jointly by KFVA and project team consultants for the implementation of disease surveillance an control in Kosovo A4.2 A10.1 From a cumulative list of all surveillance and control programs, the cost of each programme will be calculated and will include at least: the cost of vaccines and consumables; staff costs including salaries and physical resources; payments to authorised PVPs; laboratory costs; administrative costs. From this costing data, a detailed long term budget will be prepared Surveillance and vaccination programme for diseases identified by the KFVA and those for which reporting is compulsory have been drafted Key Result 2: and implemented Deliverable 2.1 Completed surveillance and vaccination plans for notifiable diseases Deliverable 2.2 Results of surveillance for notifiable diseases from the KFVA animal health lab Deliverable 2.3 Documents confirming vaccinations against notifiable diseases completed by KFVA staff or authorised PVPs Deliverable 2.4 Completed surveillance and vaccination plans for non-notifiable diseases A2.1 Prepare and implement surveillance and vaccination plans for all diseases for which reporting and notification is compulsory (according to EU and OIE procedures). A2.1 A2.1 Deliverable 2.5 Results from field surveillance for non-notifiable diseases A2.2 A2.2 Prepare and implement surveillance plans for those diseases for which reporting and notification are not compulsory but for which, on the basis of available epidemiological data, the Consultant, together with KFVA, have identified to be priority diseases for which surveillance is deemed important. Deliverable 2.6 Results of surveillance testing for non-notifiable diseases from the KFVA Food and Animal Health Laboratory A2.2

53 Key Result 3 Cost benefit analysis for control and/or eradication of selected animal diseases is prepared Deliverable 3.1 A full dossier of cost-benefit analyses for each of the notifiable and A2.3 In collaboration with KFVA, prepare cost-benefit analyses to non-notifiable diseases included, integrated into each control plan accompany the surveillance and control plans for each disease addressed within the project. Key Result 4 Contingency plans for selected animal diseases have been reviewed and updated Deliverable 4.0 A review of the current contingency plans for selected diseases is A3.1 Review the current contingency plans for selected diseases produced Deliverable 4.1 Completed updated contingency plans for each of the selected priority animal diseases A3.2 Draft contingency plans and related operational manuals for selected priority animal diseases. Deliverable 4.2 A detailed report on the status of the animal health regulatory framework in Kosovo with recommendations for revision to ensure that actions contained in the contingency plans are covered by legislation in force and recommendations for any gaps A3.3 Review the Kosovo legislation in order to verify and ascertain that actions contained in the contingency plans are covered by legislation in force. Specific legal gap analyses will be prepared should the legislation not be entirely compliant with the needs of emergency actions provided for by the contingency plans. Deliverable 4.3 Simulation exercise guidance documents for participants A3.4 In close collaboration with the KFVA, organise and implement relevant simulation exercises (desktop and field) for the major diseases. Deliverable 4.4 Desktop and field simulation exercises carried out (at least one of A3.4 each) Deliverable 4.5 Simulation exercise evaluation forms competed A3.4 Deliverable 4.6 Reports of the exercises, their efficacy and suggestions for improvements as the series progresses produced and put in Quarterly reports. A3.4

54 Key result 5 Control plan for brucellosis and clostridial diseases have been reviewed and updated. A list of needed diagnostic kits, biological materials and other consumables needed for implementation of the programme for control of brucellosis and clostridial diseases has been drafted; laboratory capacities and potential inclusion of new tests and techniques have been reviewed and updated. Deliverable 5.1 A comprehensive epidemiological study of the brucellosis situation A6.1 Collect and analyse the data on brucellosis collected in previous of Kosovo years in order to prepare an epidemiological study of the brucellosis disease situation in the country. Deliverable 5.2 Report of the analysis of the current plans for the control of brucellosis including an account of deficiencies noted A6.2 Review and analyse the currently adopted control plans for Brucellosis in detail. Deliverable 5.3 A critical review of the arrangements in place for the campaign of vaccination against brucellosis in ruminants Deliverable 5.4 A report detailing the laboratory tests and resources necessary for the support of the control programmes for brucellosis including gaps identified and requirements A9.1 Review the existing arrangements for the implementation and delivery of the vaccination campaign against brucellosis that commenced in 2010 A6.3 Assess the laboratory tests and resources (diagnostic kits, biological materials and other consumables) needed to support programmes for the control of brucellosis and identify gaps and requirements Deliverable 5.5 Annual reports on the vaccine distribution, cold chain quality and field application of the vaccine. Also the design of post-vaccination sero-monitoring, the implementation and results of this monitoring and the assessment for the efficacy of vaccination in vaccinated animals and the population overall A9.4 In close collaboration with KFVA, undertake the assessment of the operational management and delivery of the programme during the lifetime of the project. Monitor the distribution of vaccine, the maintenance of the cold chain and the field application of the vaccine. Design the post-vaccination sero-monitoring and monitor its application and results. Deliverable 5.6 A multi-annual implementation programme for the mass vaccination of small and large ruminant livestock approved A9.3 Elaborate a multi-annual implementation programme for the vaccination of small and large ruminant livestock populations against brucellosis. Deliverable 5.7 A revised control plan for brucellosis produced A6.4 On the basis of the analyses in A6.1 and 6.2, a revised version of the control plan for brucellosis will be prepared. Where possible, the plan will be profiled so as move towards a prospective disease free status. For this goal, the review will focus on the EU and OIE criteria adopted for declaration of Brucellosis disease free status. The revised plan will concentrate also on implementation measures to be adopted at field level so as to ensure that all tasks required are properly and fully implemented.

55 Deliverable 5.8 A detailed report on the cost-sharing options for financing control of brucellosis in Kosovo A9.2 Undertake an economic assessment of a range of cost-sharing options for the vaccination campaign against brucellosis (to be agreed during the inception period with the Contracting Authority and Beneficiary Authorities). Deliverable 5.9 A report on clostridial diseases of livestock in Kosovo which defines the situation and status of the various diseases involved as well as records the strengths and weaknesses of the current official control measures. A7.1 Gather the data, information and materials available Undertake a comprehensive review of existing control plans for clostridial diseases. The review shall also include an estimate of the effectiveness and costs (public and private) of the current measures Deliverable 5.10 A report on the cost-benefits of controlling the various clostridial diseases that also considers the option of financing controls by a system of cost-sharing between the public and private sectors. A7.2 Taking account of the potential costs and benefits that control of clostridial diseases entail for livestock producers and the wider economy and given the ability of clostridial bacilli and spores to persist indefinitely in the environment, undertake a review of the cost-benefits of their control paying particular attention to the long term costs of control and the desirability of ensuring appropriate cost-sharing arrangements between the public and private sectors. Deliverable 5.11 Deliverable 5.12 A report detailing the laboratory tests and resources necessary for the support of the control programmes for clostridial diseases including gaps identified and requirements Campaign delivery strategy for brucellosis and clostridial diseases produced and approved by KFVA A7.3 Assess the laboratory tests and resources (diagnostic kits, biological materials and other consumables) needed to support programmes for the control of clostridial diseases and identify gaps and requirements A5.1 A communication strategy for the delivery of information on brucellosis and clostridial diseases, in Albanian and Serbian, with reference to the particular groups to be targeted, the media to be employed (press, radio, posters etc.) and the timing of the campaign will be prepared and submitted for approval to the KFVA with amendments made as required.

56 Deliverable 5.13 Information campaign materials on brucellosis and clostridial diseases produced and approved by KFVA A5.2 Prepare and information campaign materials on Brucellosis and clostridial diseases that will include: the nature of the diseases; the economic losses to livestock farmers that result from infections; the risks to human health of brucellosis; the means by which animal and human infection can be prevented; the official measures that are in place or that will be introduced to control and prevent those diseases. The campaign will be focused both on informing private individuals on the impact of Brucellosis on human health but will also serve as communication/information for farmers and stakeholders on actions that will be undertaken by KFVA and obtain support. EU visibility rules will be taken into account in the drafting of the awareness campaign Deliverable 5.14 Report collating the implementation, feedback and analysis of the information campaign for brucellosis and clostridial diseases with recommendations for future campaigns A5.3 Implementation of the information campaign on brucellosis and clostridial diseases as planned and assessment of its effectiveness. Feedback on the campaign strategy will be collected and analysed Key Result 6 An awareness campaign on the importance of disease control and eradication for farmers and other stakeholders concerned has been designed and implemented Deliverable 6.1 Diseases for the awareness campaign selected A8.1 Disease for the awareness campaign selected by Project team and Deliverable 6.2 Campaign delivery strategy for selected diseases produced and approved by KFVA A8.2 A communication strategy for the delivery of information on the selected diseases, in Albanian and Serbian, with reference to the particular groups to be targeted, the media to be employed (press, radio, posters etc.) and the timing of the campaign will be prepared and submitted for approval to the KFVA with amendments mad as required. Deliverable 6.3 Information campaign materials on selected diseases produced and A8.3 Prepare information campaign materials on selected diseases that Deliverable 6.4 Report collating the implementation, feedback and analysis of the information campaign for selected diseases with recommendations for future campaigns A8.4 Implementation of the information campaign on selected diseases as planned and assessment of its effectiveness. Feedback on the campaign strategy will be collected and analysed

57 Component 2: Laboratory Testing Key Result 7 Training need analysis and training for the laboratory staff has been carried out Deliverable 7.1 Training needs assessment report (R7) A11.1 Conduct a training needs assessment addressed towards strengthening and upgrading laboratory testing activities performed within the veterinary laboratory. The analysis will focus on present animal health testing methods in place and on adoption of ISO quality system. Deliverable 7.2 A prepared and officially approved training programme for the staff A11.2 Based on the training needs assessment in Deliverable 7.1, prepare of the Food and Veterinary Laboratory a training programme will be submitted to the beneficiary for approval Deliverable 7.3 Training materials for participants A11.3 Prepare the training materials for the approved training programme for staff of the KFVA Food and Veterinary Laboratory testing for livestock diseases Deliverable 7.4 Returned training evaluation forms and analysis of them A11.4 Implement the training program in Deliverable 7.2 including collecting training evaluation forms. Deliverable 7.5 Reports on progress of the training programme and results obtained in the Quarterly Reports A11.5 Produce updates of progress of the training programme and results obtained Key Result 10 Deliverable 10.1 Laboratory staff trained and capable of performing laboratory tests on the selected animal diseases Full report of the training programme for laboratory staff compiled A11.5 Produce updates of progress of the training programme and results from the regular reports obtained Key Result 8 A list of test and analysis to be included in the range of laboratory services to be performed has been drafted Deliverable 8.1 A list of the livestock diseases to be covered by the KFVA Food and A12.1 In collaboration with KFVA, produce a list of the livestock diseases veterinary Laboratory is agreed with KFVA to be covered by the KFVA Food and veterinary Laboratory to include notifiable diseases and non-notifiable diseases included in Key Results 2 (notifiable and non-notifiable diseases) and 5 (brucellosis and clostridial diseases).

58 Deliverable 8.2 A list of the testing procedures to be applied for each disease for which there are surveillance, control or eradication plans with indicative quantities Deliverable 8.3 A list of the consumables (test kits, reagents etc.) necessary for carrying out the testing procedures included in Deliverable 8.2 with an indication of probable annual throughput for each procedure A12.2 Define the laboratory testing methods required for diagnosis/detection of the diseases in the list in Deliverable 8.1 and necessary to support the planned measures for surveillance and control of each of the diseases. The measures may include, where appropriate, testing samples, strain genotyping, verifying vaccination coverage. The selected methods should be in accordance with EU Regulations or Directives and OIE standards A12.3 Make a list of the consumables (test kits, reagents etc.) necessary for carrying out the testing procedures included in Deliverable 8.2 with an indication of probable annual throughput for each procedure Key result 9 A list of missing equipment and technical specifications for these equipment has been prepared Deliverable 9.1 A list of equipment required for the tests defined in Deliverable 8.2 A13.1 From Deliverable 8.2, prepare a list of equipment required to carry out the defined tests Deliverable 9.2 A list of equipment which must be repaired or procured in order A13.2 With the participation and support of KFVA Food and veterinary to meet all the tests included in Deliverable 8.2 Laboratory staff, evaluate the availability and functionality of the equipment present in the laboratory and compare this to the list in Deliverable 9.1 to determine what equipment is present and functional, present and requires repair or must be procured in order to meet the tests include in Deliverable 8.2 Deliverable 9.3 A list, including full technical specifications, of equipment to be procured for the KVFA Food and veterinary Laboratory in order to meet the test requirements in Deliverable 8.2. The list and technical specifications will be in accordance with EU PRAG rules and will include an estimate of likely overall cost. A13.3 Prepare a list, including full technical specifications, of equipment to be procured for the KVFA Food and veterinary Laboratory in order to meet the test requirements in Deliverable 8.2 The list and technical specifications will be in accordance with EU PRAG rules and will include an estimate of likely overall cost.

59 Key Result 11 Deliverable 11.1 Laboratory management systems including document management and communications system have been reviewed and updated A detailed report of the assessment of the current status of the A14.1 Assess the c current status of the management systems of Food management systems of Food and veterinary Laboratory and Veterinary Laboratory. On the basis of this, draft a proposal for a revised system that will include document management functions, possible IT application and due respect of technical issues required by ISO standard. The system must ensure reliable registration of data and traceability of samples during the testing activities. The system, which is aimed at streamlining and upgrading of the laboratory management system, will ensure reliable registration of data and traceability of samples during the testing activities. The system can be designed with a wide range of different functions. In the more sophisticated applications, an IT system, directly interfaced with the analytical testing instruments, could be envisaged. Deliverable 11.2 Deliverable 11.3 A detailed proposal for a revised and streamlined management system for the KFVA Food and Veterinary Laboratory A financial strategy to match the available budget to the cost of the upgrade of the laboratory management system of the KFVA Food and Veterinary Laboratory A14.1 A14.2 Make a prior assessment of available budget with a view towards profiling a cost effective laboratory management system in line with KVFA financial allocation

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61 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex C Indicative Timetable of Activities for PY1 and PY2 Consortium Agrotec SpA / NIRAS / IZSVe 30

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63 Key Result 1 D 1.1 A1.1 D 1.2 A1.1 D 1.3 A1.2 D 1.4 A4.1 D 1.5 A4.2 D 1.6 A4.2 D 1.7 A4.2 D 1.8 A10.1 KAHL Project Inception Report Indicative Timetable of Activities PY1 Q1 PY1 Q2 PY1 Q3 PY1 Q4 PY2 Q1 PY2 Q2 PY2 Q3 PY2 Q4 M A M J J A S O N D J F M A M J J A S O N D J F Component 1: Animal disease control Key Result 2: D 2.1 A2.1 D 2.2 A2.1 D 2.3 A2.1 D 2.4 A2.2 D 2.5 A2.2 D 2.6 A2.2 Key Result 3 D 3.1 A2.3 Key Result 4 D 4.1 A3.1 D 4.2 A3.2 D 4.3 A3.3 D 4.4 A3.4 D 4.5 A3.4 D 4.6 A3.4

64 Key result 5 D 5.1 A6.1 D 5.2 A6.2 D 5.3 A9.1 D 5.4 A6.3 D 5.5 A9.4 D 5.6 A9.3 D 5.7 A6.4 D 5.8 A9.2 KAHL Project Inception Report Indicative Timetable of Activities PY1 Q1 PY1 Q2 PY1 Q3 PY1 Q4 PY2 Q1 PY2 Q2 PY2 Q3 PY2 Q4 M A M J J A S O N D J F M A M J J A S O N D J F D 5.9 A7.1 D 5.10 A7.2 D 5.11 A7.3 D 5.12 A5.1 D 5.13 A5.2 D 5.14 A5.3 Key Result 6 D 6.1 A8.1 D 6.2 A8.2 D 6.3 A8.3 D 6.4 A8.4

65 Key Result 7 D 7.1 A11.1 D 7.2 A11.2 D 7.3 A11.3 D 7.4 A11.4 D 7.5 A11.5 KAHL Project Inception Report Indicative Timetable of Activities PY1 Q1 PY1 Q2 PY1 Q3 PY1 Q4 PY2 Q1 PY2 Q2 PY2 Q3 PY2 Q4 M A M J J A S O N D J F M A M J J A S O N D J F Component 2: Laboratory Testing Key Result 10 D 10.1 A11.5 Key Result 8 D 8.1 A12.1 D 8.2 A12.2 D 8.3 A12.3 Key result 9 D 9.1 A13.1 D 9.2 A13.2 D 9.3 A13.3 Key Result 11 D 11.1 A14.1 D 11.2 A14.1 D 11.3 A14.2

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67 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex D Indicative Timetable of Deployment of Personnel for PY1 and PY2 Consortium Agrotec SpA / NIRAS / IZSVe 31

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69 KAHL Project Inception Report Indicative Personnel Deployment PY1 PY2 PY1 PY2 Totals Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Key Experts KE1 Team Leader KE2 Animal health expert Senior Short-Term Experts SSTE Disease control SSTE Veterinary diagnostics SSTE Livestock economics SSTE HR Management and Training SSTE Information technology SSTE Communications & media SSTE Legislation SSTE Brucellosis Junior Short-Term Experts JSTE Disease control and surveillance JSTE Contingency plans and simulation exercises JSTE Livestock economist JSTE HR Management and Training JSTE Communications & media JSTE Legislation JSTE Unallocated 186 KE SSTE JSTE Total

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71 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex E Indicative Incidental Expenditure Budget for PY1 and PY2 Consortium Agrotec SpA / NIRAS / IZSVe 32

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73 KAHL Project Inception Report Indicative Incidental Expenditure Budget Code Item PY1 PY2 Total % of Total Indicative Incidental Expenditure C1.1 Workshop 10,500 1,500 12,000 C1.2 Seminar 800 1,200 2,000 C1.3 Training materials 1, ,600 C1.4 Desktop simulation exercise 0 1,000 1,000 C1.5 Field based simulation exercise 0 2,000 2,000 C1 Training 13,200 6,400 19, C2.1 Animal Health 20, ,000 C2.2 Laboratory techniques 6,000 12,000 18,000 C2 Study visits 26,000 12,000 38, C3.1 Brucellosis SR post-vaccination 12,000 12,000 24,000 C3.2 Brucellosis SR prevalence 9,000 9,000 18,000 C3.3 Brucellosis cattle prevalence 3,000 3,000 6,000 C3.4 Bovine TB survey C3.5 BVD / IBR sero-survey 3,000 3,000 6,000 C3.6 Clostridia testing C3.7 Bluetongue sero-survey 3,000 3,000 6,000 C3.8 CSF / ASF testing C3.9 HPAI / ND testing C3.10 Epidemiological investigation 1,000 1,200 2,200 C3.11 Disease identification and reporting ,150 C3.12 Sample collection and transport 700 1,600 2,300 C3 Surveillance and testing 32,360 34,030 66, C4.1 Field travel 18,200 14,400 32,600 C4.2 Per diem ,260 C4 Travel and per diem 18,650 15,210 33, C5.1 Printing C5.2 Radio spot 3,000 2,000 5,000 C5.3 Television spot 12,000 8,000 20,000 C5.4 Public meetings / workshops 9,000 6,000 15,000 C5.5 Direct marketing C5 Public information campaign 24,018 16,012 40, PSC1 Meeting PSC2 Document translation PSC Project Steering Committee Allocated totals 114,228 83, , Contingency 2, Overall total 200,

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75 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex F Assumptions And Risks including Risk Management Plan Consortium Agrotec SpA / NIRAS / IZSVe 33

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77 KAHL Inception Report: Project Assumptions N Assumptions based on the tender dossier and clarified by our expert team Commitment towards EU accession is confirmed throughout the duration of the project. The Government of Kosovo allocates adequate funding for sustained control and eradication of priority animal diseases. Qualified veterinarians and/or technicians are available to undergo training and implement plans and measures introduced by the project. Comment/Consultant assessment EU accession is a major objective for the Government and people of Kosovo and, in view of the strong support from EU institutions, that position is very unlikely to change. The will is almost certain to be there, since the project objectives fit well with the new ARDP, shortage of funds could, however, be a problem. This potential problem, real because of staff shortfalls, would have to be overcome by carefully planning the training and by having commitments from managers to make staff available.

78 KAHL Inception Report: Project Risks and Risk Management Plan N Risk Comment Probability Impact Monitoring & Mitigation Strategy Political instability in certain regions of Kosovo could impede full and proper implementation of project activities. Insufficient budget allocated to Animal Health Unit of KFVA Incursion of diseases from neighbouring countries could jeopardise the impact of animal health strategies implemented within Kosovo Although the situation now appears to be more stable in the country tensions persist and there is always the possibility of volatility returning. Insufficient budget is a permanent problem for KFVA: the issue is whether co-operation with the project would be a top priority for the limited finances. This is an ever-present possibility and part of the justification for the project. Medium Medium Medium Low High Medium The situation is monitored by the EU Office, and warnings would be given of serious trouble. At a low level of instability the project could probably continue to work, depending on the advice of the EUO. It would be necessary to have an early warning of budget difficulties. In such an event the TL would consult with the EU Task Manager and seek a diplomatic intervention to relieve the problem. It could be treated not as a failure of the system; but as a demonstration of what could easily happen at any time. The situation would provide a live training exercise with PT experts deeply involved in the control activities.. 4 That individual livestock owners or groups fail to co-operate in the new surveillance and control measures. In view of previous collaboration, such an event does not seem to be particularly likely. Low Low Occasional failures are not significant. Persistent or group resistance would require veterinary inspectors and PVPs, supported by PT experts, to attempt persuasion. 5 That the large numbers of holdings with small numbers of sheep make the practical implementation of the project difficult. This is essentially a problem of trying to carry out the campaigns with limited staff numbers. Low Low Veterinary inspectors are already familiar with this constraint and probably have strategies to mitigate the problem e.g. having numbers of sheep gathered in one place in a village. This risk would probably only become a real constraint if project activities require a large expansion of vaccination and/or active surveillance.

79 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex G Report of the KE2 Animal health Consortium Agrotec SpA / NIRAS / IZSVe 34

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81 EuropeAid/133795/DH/SER/XK DRAFT MISSION REPORT 02/03/2015 to 13/03/ /03/2015 to 03/04/2015 Stefano Nardelli 1

82 Table of Contents PURPOSE OF THE MISSION... 3 ITINERARY... 3 METHOD... 3 RESULTS... 4 ASSESSMENT OF THE CURRENT SITUATION OF THE AHS... 4 STRATEGY DRAFT Diagnostic procedures Quality management system... 8 MAIN CONCLUSIONS SUMMARY OF ACTIVITIES ACTION PLAN (NEXT STEPS)

83 Purpose of the mission The mission mainly focused on the following activities: 1. Animal health laboratory: to assess the current situation of the Animal Health Section (AHS) of the Kosovo Veterinary and Food Laboratory (KFVL) 2. Inception report: to define a strategy draft aiming at giving the technical assistance to AHS Itinerary ,5 Meeting with the team leader Meeting in the KFVA (Shaban Gollopeni, Bafti Murati) Meeting in the KFVL (Fillojete Rrustemaj, Beqe Hulaj, Izedin Goga) Meeting in the KFVA (Shaban Gollopeni, Bafti Murati) Reviewing the OIE-, EU- and RKS- legal provisions on animal diseases /// Not working day /// Not working day Reviewing the quality calibration procedures of the KFVL Meeting in the KFVA (Valdet Gjinovci, Fillojete Rrsutemaj, Shaban Gollopeni) Drafting the proposal list of the "major" diseases Meeting in the KFVL (Fillojete Rrustemaj, Beqe Hulaj) - Meeting in EEAS (Arton Osmani) ,5 Meeting in the KFVA (Shaban Gollopeni, Bafti Murati) ,5 Drafting the proposal list of the "major" diseases Meeting in the KFVA (Shaban Gollopeni, Bafti Murati, Berat Hoxha) Reviewing the LIMS requirements with the KAHL IT consultant (Andres Jatsa ) Meeting in the KFVA (Bafti Murati, Nazmi Qollaku, Andres Jatsa) ,5 Meeting in the KFVA (Bafti Murati, Shaban Gollopeni) Persons met Dr Shaban Gollopeni Dr Berat Hoxha Mr Nazmi Qollaku Dr Bafti Murati Dr Fillojetё Rrustemaj Dr Beqe Hulaj Dr Izedin Goga Dr Valdet Gjinovci Dr Arton Osmani Food and Veterinary Agency Food and Veterinary Agency Food and Veterinary Agency Food and Veterinary Laboratory Food and Veterinary Laboratory Food and Veterinary Laboratory Food and Veterinary Laboratory CVO EEAS - Pristina Method Inapplicable 3

84 Results ASSESSMENT OF THE CURRENT SITUATION OF THE AHS AHS is one of the sections of the KFVL, which includes other departments, such as chemistry food analysis etc., which are not involved in the current project. AHS is divided in four branches, i.e.: Bacteriology and Parasitology o Chief of sector Beqë Hulaj (Vet) o Staff Graduated Saranda Ahmeti (Vet) Technicians /// Serology o Chief of sector Dafina Ymeri (acting Biol) o Staff Graduated Jeton Spahiu (Vet) Malbora Shandro (Vet) Technicians /// Virology and Molecular Biology* o Chief of sector Vacancy /// o Staff Graduated /// Technicians /// (*)this specific branch currently empty- is scheduled to be activated soon Histopatology o Chief of Sector Izedin Goga (Vet) o Staff Graduated /// Technicians /// Support staff (sample submission) Lumnije Shala (agr. engineer) Naile Osmani (food technologist) The workload of AHS is shown in annex no. 4, which is an excerpt of the report (for the year 2014) sent by the Kosovo Food and Veterinary Agency to the CVO. According to this report, almost all samples have been submitted for serological analyses (supposed to be mainly Brucella serological tests, Elisa and Rose Bengal Test -RBT-), whereas other submissions are very few. This issue has to be carefully taken into account, because at least for some sectors the workload seems to be low, and the lower it is, the higher the probability of loosing technical competence. During the mission, the list of the diagnostic procedures which are currently in place in the different labs of the AHS has been required (see annexes 1 2 3). Within AHD, some -only serologicalprocedures have been accredited (see annex no. 1) by the Directorate for Accreditation of Kosovo (DAK). According to what currently declared in the DAK website ( i.e. The vision of DAK is to become full member of EA (European cooperation for Accreditation) and to sign the EA MLA as soon as possible, it is clear that DAK has still to be internationally recognized (as acknowledged by the KFVL Quality Manager Dr Fillojetё Rrustemaj). As a consequence, accreditation certificates issued by DAK do not have (at least to date) any official legal value at international level: of course, this does not mean that, from a substantial point of view, a properly structured Quality Management System (QMS) has not been put in place in the laboratories audited and accredited by DAK. When reviewing the list of the serological procedures, it has to be highlighted that all DAK-accredited procedures are based on Elisa reaction as far as the Brucella antibody detection is concerned (which is the most relevant disease to be taken into account in the framework of the project), 4

85 o the rapid agglutination (Rose Bengal Test RBT) is in place, but it has still to be accredited o the complement fixation has not been implemented o Elisa for Brucella melitensis antibody detection in blood samples of small ruminants has been established (according to the OIE manual) and accredited, but this serological procedure is not legalised / acknowledged by the EU legislation (Council Directive 91/68/EEC) When reviewing the list of the bacteriological procedures, it has to be highlighted that No procedure is in place for the isolation/identification of Brucella spp as well as of Yersinia enterocolitica, which prevents the lab from further investigating Brucella outbreaks diagnosed on a serological basis; this situation is related to the lack of a BSL-3 level laboratory, which does not allow to manipulate Brucella strains under proper conditions (also considering the biological risk for the lab staff) As far as clostridial enterotoxemia is concerned, the lab carries out an immunochromatographic rapid lateral flow test for alfa and epsilon toxin of Clostridium perfringens; bacteriological as well as molecular biology techniques are not used, primarily because of the lack of reagents (PCR, bacteriological media) As far as the Virology and Molecular Biology unit is concerned, the absence of dedicated staff, which does not allow to have a routinely diagnostic activity in place the lack of sample submissions, due to (also) the current regulatory provisions of the Kosovo competent authorities, which do not include molecular techniques among the diagnostic procedures which have to be implemented/utilised for the diseases of major concern represent the main drawbacks. By the way, the Molecular Biology Unit laboratory is almost brand new, properly designed and equipped, and inside KFVL people with an adequate training are present. As far as the DAK-accreditation of the KFVL is concerned, a Quality Management System (QMS) has been put in place. Within AHS: All the lab equipment were regularly maintained and checked, except for the Elisa reader, which currently has never been calibrated. However, recently calibration and maintenance contract with external companies have expired and, as a consequence, o filters of the flow cabinets have not been replaced o micropipettes have been sent for calibration to an external body (Kosovo metrological Agency) which is completely lacking of any accreditation (unlike the previous one -Eramed-) see below Calibration procedures for thermometers and micropipettes (which are the only measurement instruments which are currently used inside the department) are outsourced to external companies (micropipettes Eramed, and more recently Kosovo Metrology Agency - ; thermometers Kosovo Metrology Agency) which lack of a fully recognized ISO17025 accreditation as calibration laboratories. To date, Kosovo Metrological Agency was never accredited at all, whereas Eramed was accredited by the same accreditation body of KFVL, i.e. DAK (which is not a full EA member, as above reported). For this reason, calibration certificate issued for both thermometers and micropipettes are not valid at international level, although they are generally properly structured and filled. The only remark regards the calibration certificate of the micropipettes, which (at least in Eramed certifcates) does not identify the scale which was used and does not allow to understand its resolution (which is a relevant requirement defined in the ISO 8655 regulation). Samples are properly registered and identified at their arrival in the lab, by using o A unique submission code (year/submission e.g. 15/403 year 2015, submission no. 403) o A unique sample identification: samples belonging to the same submission are identified by a progressive number, usually starting from 1; e.g. if the submission 15/403 consist of 5

86 10 samples, they will be uniquely identified in the following way 15/403/1, 15/403/2,, 15/403/10. o In the lab archive, for each submission the correspondence between Submission ID and farm of origin Sample lab ID and eartag of the animals is properly tracked and stored STRATEGY DRAFT Referring to activities listed in the Technical Proposal Component 2, laboratory testing, in this inception phase following main actions have to be undertaken: Activity 12: Draw up a list of laboratory testing methods needed to adequately support the animal health plans elaborated within other activities (e.g. 1, 2, 6 and 7). The methods will conform to the technical features of the laboratory methods suggested by EU Regulations or Directives and by OIE standards for different functions of the plans (testing samples, strain genotyping, verifying vaccination coverage, etc.). Starting with the assumptions that Taking into account the small size of the country, it is meaningless to request that KFVL must be able to properly manage each animal disease, but a selection has to be made aiming at identifying which are the major diseases whose diagnosis/management can be outsourced (e.g. by shipping the samples to NRLs of other countries) KFVL is the only public veterinary laboratory in Kosovo, and therefore that, at least for the diseases which can considered as relevant / not outsourceable for this specific geographic area, it has to play the role of NRL and therefore it has to be capable to carry out at least the basic / fundamental diagnostic procedures which have to be in place in order to ensure a reliable diagnosis the first step is represented by the definition of the major veterinary diseases which have to be included in the diagnostic portfolio of KFVL. After defining the list of major diseases, it will be possible To accurately define the list of laboratory testing methods needed to adequately support the animal health plans (Activity 12) To conduct a training needs assessment and to draft a training programme of the Laboratory staff (Activity 11) In order to create this list of major diseases, six main starting points have to be considered: 1. The OIE-Listed notifiable diseases, infections and infestations in force in 2015 ( 2. The EU-regulations defining the list of the notifiable diseases, which are o Council Directive of 26 June 1964 on animal health problems affecting intra- Community trade in bovine animals and swine (64/432/EEC) o Council Directive of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-community trade in certain live animals and products with a view to the completion of the internal market (90/425/EEC) o Council Directive of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (92/65/EEC) 3. The EU-regulations regarding sanitary controls for intra-community trade of animals o Council Directive of 26 June 1964 on animal health problems affecting intra- Community trade in bovine animals and swine (64/432/EEC) 6

87 o Council Directive of 28 January 1991 on animal health conditions governing intra- Community trade in ovine and caprine animals (91/68/EEC) o Council Directive of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (92/65/EEC) o Regulation (EC) of the European Parliament and of the Council of 22 may 2001 laying down rules for the prevention, control and eradication of certain Transmissible Spongiform Encephalopathies (999/2001) o Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue Bluetongue 4. The EU-regulations regarding sanitary controls on breeding animals o Bulls: Council Directive of 14 June 1988 laying down the animal health requirements applicable to intra-community trade in and imports of semen of domestic animals of the bovine species (88/407/EEC) Commission Regulation (EC) No 1266/2007 (see above) - Bluetongue o Stallions, boars, rams, bucks: Council Directive of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (92/65/EEC) As far as this specific issue is concerned, attention should be focused on bulls, because in the only breeding station which is present in Kosovo only bulls are kept 5. The Kosovo list of notifiable diseases according to current legal provisions of the Kosovo republic (Veterinary Law 2004/21) 6. The current epidemiological situation in the Balkan region On this basis, it looks to be reasonable, at least on a tentatively way, to identify a list of selected major diseases (which is of course shorter than the OIE one), for which the KFVL must have the diagnostic capability, in terms of equipment / staff / reagents (lab consumables, kits), even if the no. of submitted samples is / will be presumably low. For example, According to the Veterinary Law Rift Valley Fever is a notifiable disease, but it is not appropriate to have in place diagnostic procedures regarding this diseases, which has never been described in Europe For Classical Swine Fever (CSF) currently KFVL carries out ELISA tests for antibody detection (useful in wild boars, but not in domestic vaccinated pigs) as well as for antigen detection; the implementation of more sensitive virological techniques (e.g. PCR kits which are commercially available and validated by EU NFLs, like as ADIAVET TM CSFV Classical Swine Fever PCR Kit) would greatly improve the KFVL diagnostic capability A tentative list of the major disease has been drafted in annex no. 6a 6b 6c. Annexes no. 7a 7b 7c are an excerpt of the EU-provisions listing the notifiable diseases for different animal species. Annex no. 6a aligns the OIE list of notifiable diseases, the Kosovo Veterinary Law 2004/21 and the mail EU legal provisions concerning notifiable diseases control/eradication programmes control of breeding animals. Annex no. 6b is a proposal, excerpted from annex no. 6a, of the major diseases which should be covered by the KFVL diagnostic capabilities. According to this proposed list most of the OIE-notifiable diseases are not worthy being classified as major diseases, e.g. because that o o never occurred in Europe are not have been reported in Europe since a lot of time (Transmissible Gastroenteritis of Swine) 7

88 some of the Kosovo-notifiable diseases indeed are not worthy being classified as major diseases, e.g. because they never recently occurred in Europe (Rinderpest, Rift Valley Fever) All diseases for which compulsory controls have been laid down in the framework of either control programmes (bovine, swine, small ruminants) or sanitary controls on breeding animals (bulls, small ruminants) have been included According to this approach, an adequate budget has to be allocated, mainly aiming at ensuring an adequate reagent supply, even for those diseases (e.g. CSF, FMD) for which sample submission is strictly related to clinical suspicions, and therefore it could be very low; this issue is relevant in particular for the molecular biology reagents (e.g. PCR kits) which, as a general rule, are expensive but, at the same time, definitely are the only diagnostic tool which -for many diseases- allow to issue a reliable negative lab result. At least in this initial inception phase of the project, in KFVL equipment do not represent a major drawback for the current and future main lab activities the regular participation of KFVL laboratory in international (e.g. at EU level) proficiency tests has to be ensured the personnel shortage of the KFVL has to be considered, if the future daily workload of the laboratory has to be increased (and it should be, in particular if molecular techniques will be implemented at least for some major diseases listed in annex no. 6b). After defining the tentative list of major diseases, for each of them (annex 6c) has been identified the role of primary/active surveillance the priority level (basing on the list of notifiable diseases according to the RKS law) the list of diagnostic techniques which are already in use / eligible to be established in the KFVL (annex 6c). Of course, the draft list has been agreed with the KFVA and KFVL managers, but it will for sure again discussed and reviewed, in particular as far as the definition of the testing procedures to be implemented in the laboratory. In any case, at least for the following procedures specific actions must be undertaken: Bacteriological examination for Brucella spp with conventional (microbiological including Yersinia enterocolitica isolation) techniques, which currently is not carried out. In practical terms: o a short term expert should be identified, who will be in charge of liaising with the KFVL personnel and of organising specific training activities, both in loco and in foreign labs (study tour) o due to biosafety reasons, since KFVL by now does not have (but in the next future it will have) a BSL3 facility, the practical training will be done using Brucella neotomae strains, which are recognised as non-zoonotic, but at the same time show a growth pattern which is very similar to Brucella abortus / melitensis strains Reactivation of the molecular biology techniques, which should be utilised for most of the major diseases. In practical terms: o a short term expert should be identified, who will be in charge of liaising with the KFVL personnel and of organising specific training activities, both in loco and in foreign labs (study tour) o as a first step, a model disease (or group of related diseases) could be selected, for which specific PCR techniques (mainly based on commercial kits) should be introduced and, consequently, equipment and lab reagents should be reviewed and -if neededupdated; as model disease, PCR for Pestivirus infection could be suggested, because in this case the same set of PCR techniques will enable the lab to properly carry out the diagnosis of CSF as well as BVD infections; Activity 13: Check availability of equipment needed for execution of tests listed under Activity 12 and, for missing equipment, prepare technical specifications, drafted in accordance with the PRAG requirements. 8

89 As long as the list of major diseases has not been defined, it is too early to check the availability of equipment needed for execution of diagnostic tests. However, as far as the quality management system of KFVL is concerned, the unavailability of calibration equipment can be seen at a glance; consequently, the calibration of all lab measurement instruments must be outsurced (in this case Eramed, Kosovo Metrological Agency). This issue has to be carefully discussed. The main finding is represented by the lack of an international value of DAK accreditation. Currenlty, DAK is an Associated Member of the EA (European co-operation for Accreditation - but it did not sign any EA Multilateral Agreement (EA MLA - The signatories of the MLA Agreement recognise and accept the equivalence of the accreditation systems operated by the signing members, and also the reliability of the conformity assessment results provided by conformity assessment bodies accredited by the signing members. The EA website clearly states that ( the five steps to check the reliability of a certificate or a report are: Check that there is an accreditation mark on the report or certificate. Check that the accreditation mark is of an accreditation body signatory to the EA, ILAC or IAF MLA. Check that your supplier is accredited for the competence, the tests, the results you need. Check that the tests have been carried out against international standards. Alternatively, check that the standards, methods used can be accepted in the country of destination. In case of problems, contact the national accreditation body Consequently, accreditations issued by DAK to KFVL as well as to Eramed do not have any official value at international level. For the same reason, currently all calibration certificates issued by Eramed (and, even more so, by Kosovo Metrology Agency, which has never been accredited by anybody) do not have any official value, although they are (mostly) properly structured and filled. Two main possibilities are available in order to fix this issue, i.e. a) To wait for the accreditation of DAK by (higher) accrediting bodies at an international level b) To provide KFVL with the equipment which are necessary in order to enable the KFVL personnel to carry out the calibrations of the lab instruments by himself, applying internal calibration procedures. Option a) must necessarily taken into account, i.e. there is an urgent need for DAK of becoming accredited in order to provide its certifications (released to diagnostic KFVL- as well as calibration Eramed- laboratories) with an internationally recognized legal value. However the second option b) must be carefully considered, due to the significant cost savings of money that can be achieved. It is easy to compare the current costs for calibrating the KFVL lab devices when outsourcing the activity or carrying out it using internal procedures as well as personnel. The detailed comparison is drafted in annex no. 5, by indicating a) Costs for calibrations outsourced to an external service b) Costs for calibrations carried out internally: in this case the cost of the equipment (purchase + calibration) is given, and the purchase cost if expressed ad depreciation charge on a ten year basis (which I the average duration of such devices). It is easy to demonstrate that the outsourcing of metrological activities is a) more expensive, the more the higher is the no. of devices which undergo calibration procedures; currently, costs are more or less the same for both options, but option <a> does not include costs for the calibration of neither the Elisa reader nor the multichannel micropipettes (whereas option <b> does) as soon as the no. of devices to be calibrated increases ( e.g. the no. of micropipettes), costs of option <a> are doomed to increase as well (whereas costs of option <b> do not change) 9

90 as soon as the DAK become a full EA member (therefore entitled to accredit calibration laboratories issuing certificate with a full international value), the cost of the certificates issued by Eramed will probably increase option <b> enables KFVL o to calibrate low-volume delivering micropipettes (e.g. those used in molecular biology techniques) o to measure the thermal uniformity of the incubators (ISO 7218 requirement), which currently is not assessed b) not always fulfilling the requirements set up in the ISO17025 regulation, in particular as far as the accreditation of the external calibration laboratories is concerned: it has to be reminded that, basing on ISO17025, calibrations properly done by internal adequately trained- personnel are recognized by external auditors, whereas calibration certificates issued by external non accredited labs are not. For this reason, a specific activity regarding the establishment of internal procedures of calibrations has been detailed in the strategy draft. MAIN CONCLUSIONS The first decision which must be taken regards the definition of the list of major diseases which require a specific diagnostic capability of the KFVL. Annex no. 6a represents a draft proposal, which should be considered as a starting point. Of course, for many disease (OIE-listed and/or EUnotifiable) the better and money-saving approach is to rely on the support of foreign labs (e.g. EU NRLs), with which specific agreements have to be drawn up; but, for the diseases which will be recognized / classified as major, the KFVL diagnostic competence must be ensured, at least for some fundamental procedures. Once defined the list, a quantitatively adequate sample submission to the KFVL must be ensured, at least for some of the diseases and as far as possible (but in any case not only for Brucella antibody detection, as happens today); this is a pre-requirement in order to maintain the technical competence of the lab. Secondly, aiming at improving KFVL in order to fulfil the diagnostic requests which arise from the redefined list if diseases (which will be surely larger than the current one), following issues have to be considered: Regulatory issue: once defined the list of major diseases, o the Kosovo Veterinary law should be amended o specific testing activities should be implemented (e.g. monitoring programmes for other diseases with respect to Brucella), of course aiming at better drawing the animal health status in Kosovo, but also at increasing the no. of samples submitted as well as of diagnostic techniques routinely employed in the lab Equipment issue: no specific comments regarding the lab equipment; a decision should be taken whether to keep on outsourcing the calibration activities or to establish internal procedures; in the second case, an initial investment of (for the purchase) / (for the initial calibration of the devices) should be allocated - costs are given without VAT, basing on values given for supplies in Western Europe countries -, but there are clear advantages, both at economical and technical level, which justify the purchase in the writer s opinion Personnel issue: the current staff does not guarantee that future significant increases of the workload can be properly born / managed; in particular, the shortage of non-graduated technicians has to be highlighted Financial issue: if KFVL must be able to properly carry out the diagnosis of the major diseases, an adequate reagent supply must be ensured, including also diagnostic kits (mainly for Elisa as well as PCR reactions), which could be more or less expensive, but which have to be immediately available in the lab e.g. in case of clinical suspicions. 10

91 SUMMARY OF ACTIVITIES UNDERTAKEN DURING THE MISSION RELATED TO ACTIVITIES DEFINED IN THE PROJECT TECHNICAL PROPOSAL - Component 2 Laboratory testing Activity 11 - Conduct a training needs assessment and draft a training programme for the laboratory staff - Implement the training programme Training need can be assessed and training programme can be defined properly as soon as the list of the major diseases to be managed at KFVL level has been defined (see activity no. 12) Activity 12 Draw up a list of laboratory testing methods needed to adequately support the animal health plans elaborated within other activities (e.g. 1, 2, 6 and 7). The methods will conform to the technical features of the laboratory methods suggested by EU Regulations or Directives and by OIE standards for different functions of the plans (testing samples, strain genotyping, verifying vaccination coverage, etc.). A list of major diseases has been drafted (annexes no. 6b-6c), for which diagnostic procedures must be put in place in KFVL. After agreeing upon the list with Kosovo competent veterinary authorities, for each major disease diagnostic procedures will be identified which must be operating in KFVL which have to be outsourced to foreign labs (typically: EU NRLs) On this basis, training needs (see activity no. 11) will be assessed. Activity 13 Check availability of equipment needed for execution of tests listed under Activity 12 and, for missing equipment, prepare technical specifications, drafted in accordance with the PRAG requirements. As for activity no. 12, after defining the list of the major diseases as well as of the related diagnostic procedures to be implemented, equipment needs will be assessed. Regarding the quality management system, a proposal has been drafted (annex no. 5) pointing towards the establishment of internal procedures, which fix the issue of the missing accreditation of (at least some) external labs committed with the calibration of the KFVL devices includes devices which to date have never been calibrated (multichannel micropipettes, Elisa reader) is less expensive (in a medium-long term perspective) Activity 14 - Draft a proposal for a revised system that will include document management functions, possible IT application and due respect of technical issues required by ISO standard. The system must ensure reliable registration of data and traceability of samples during the testing activities. The system, which is aimed at streamlining and upgrading of the laboratory management system, will ensure reliable registration of data and traceability of samples during the testing activities. The system can be designed with a wide range of different functions. In the more sophisticated applications, an IT system, directly interfaced with the analytical testing instruments, could be envisaged. - Make a prior assessment of available budget for upgrading the laboratory with a view towards profiling a cost effective system in line with KVFA financial allocation. 11

92 The current system ensures reliable registration of data and traceability of samples during test activities, basing on (manual) paper records. Together with the KAHL Information Technology, an evaluation of possible approaches for establishing a LIMS inside KFVL has been initiated. 12

93 Action plan (Next steps) Action Basing on the draft list of major disease, defining the first set of diseases and related lab techniques which have to be established (tentatively: vesicular diseases, African/classical swine fever, brucellosis) Defining a training programme (entrusted to a short term expert) regarding Brucella spp / Yersinia enterocolitica detection by means of bacteriological culture Defining a training programme (entrusted to a short term expert) regarding the diagnosis of animal diseases with molecular techniques Person(s) responsible Stefano Nardelli Stefano Nardelli Stefano Nardelli Deadline Within the end of the next mission (Key Expert 2) Within the end of the next mission (Key Expert 2) Within the end of the next mission (Key Expert 2)

94 Annex 1: list of the diagnostic techniques inside AHD serology lab Nr Testing Materials Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Blood Serum Testing Parameter Methods Testing Equipment Antibodies against Leucosis Antibodies against BVDV (Bovine Viral Diarrhoea Virus) Antibodies against CSFV(Classical Swine Fever) Antigen of CSF (Classical Swine Fever) virus Antibodies against IBR (Infectious Bovine Rhinotracheitis) Antibodies against Brucella melitensis in small ruminants Antibodies against Brucella abortus in cattle Bluetongue Toxoplasmosis Q-fever Chlamydiosis Brucella abortus, ovis, caprine Brucella abortus milk test FMD (Foot and Mouth Disease) OIE Terrestrial Manual OIE Terrestrial Manual OIE Terrestrial Manual OIE Terrestrial Manual OIE Terrestrial Manual OIE Terrestrial Manual OIE Terrestrial Manual ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant Measurement range 450 nm 450 nm 450 nm 450 nm 450 nm 450 nm 450 nm 450 nm 450 nm 450 nm 450 nm Measurement accuracy For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% Status Accredited Accredited Accredited Accredited Accredited Accredited Accredited Not Accredited Not Accredited Not Accredited Not Accredited Rose Bengal Not Accredited ELISA Reader Tecan Nanoquant ELISA Reader Tecan Nanoquant 450 nm 450 nm For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% For 0-2 OD < ± (1 % + 10 mod) For 2-3 OD < ± 2.5% Not Accredited Not Accredited 14

95 Annex 2: list of the diagnostic techniques inside AHD bacteriology lab Analysis Procedure Listeria Monocytogenes Salmonella spp Bacillus Anthracis OIE Terrestrial Manual 2014Chapter Listeria monocytogenes IS0 6579:2002 FDA,Amd1 OIE Terrestrial Manual 2012 chapter Anthrax Paenibacillus larvae ssp larvae OIE terrestrial manual 2008 chapter American foulbrood of honey bees Melissococcus plutonius OIE terrestrial manual 2008 chapter European foulbrood of honey bees Paenibacillus larvae ssp larvae Immunochromatographic test -lateral flow VITA, UK Melissococcus plutonius Immunochromatographic test -lateral flow VITA,UK Nosema OIE Terrestrial Manual, 2013Chapter Nosemosis of honey bees Varroa destructor OIE terrestrial manual 2008 chapter varroosis of honey bees Acarapis woodi OIE Terrestrial Manual 2008 chapter acarapisosis of honey bees Antibiogramme Kirby Bauer protocol 15

96 Annex 3: list of the diagnostic techniques inside AHD pathology lab 1 Autopsia e kufomave te kafsheve/the autopsy of the of animals carcases 2 Ekzaminimi histopatologjik i indeve te kafsheve/histopathological examination of animal tissues 3 Ekzaminimi i terbimit me testin e imunofluorescences direkte/examination of rabies with direct immunofluorescence test. 4 5 Ekzaminimi i markerit ( tetraciklineve) te vaksines se terbimit me mikroskop fluorescent/examination of the rabies vaccive marker (tetracycline) with fluorescent microscope. Ekzaminimi i serumit te kafsheve te egra(dhelprave) ne pergjigje imunologjike kunder virusit vaksinal te terbimit me testin ELISA/Examination of serum of wildlife (foxes) in the immune response against rabies vaccine virus with ELISA test. 16

97 Annex no. 4: samples submitted to AHS during 2014 (RAPORTI VJETOR I DSHMK për vitin 2014) 17

98 Annex no. 5: economical comparison of calibration activities Outsourced to external bodies Carried out inside KFVL with internal procedures as well as personnel CALIBRATION: OUTSOURCED Lab Device Frequency of Physical No. Of Total Cost Unit Cost calibration Characteristics Devices (per year) Thermomether yearly Temperature Micropipette (mono) yearly Volume (1) Micropipette (multi) yearly Volume 8 Not calibrated Scale (technical) yearly Weight 8 80 (1) 640 Scale (analytical) yearly Weight (1) 200 Elisa reader yearly Absorbance 3 Not calibrated Total (yearly cost) Lab Device Thermomether Micropipette Scale Elisa reader CALIBRATION: INTERNAL Reference device (2) depreciation Frequency of Costs charge/year Description calibration Purchase Calibration (3) Calibration/year Certified 150 Every 2 years (5) thermometer (4) 500 Certified Every year (6) 6-digit scale Hygromether 100 Every 3 years Barometer (7) 300 Certified 130 Every 3 years weights 250 Certified grey 250 Every 3 years glass plate 500 Total (yearly cost) CURRENT YEARLY COST Outsourced Not including Elisa Reader / multichannel micropipettes calibration Currently not ISO17025 compliant Increases with the no. of devices Internal Including Elisa Reader / multichannel micropipettes calibration ISO17025 compliant Does not increase with the no. of devices (1) current costs paid to the external calibration service, which are not ISO17025 accredited (scales - Kosovo Metrology Agency) or sub iudice accredited (micropipettes, thermometers - DAK) (2) device used for calibrating lab devices (3) calibration of the reference device carried out by an ISO17025 accredited lab (4) 0,00 C resolution equipped with 3 thermal sensors in order to map the temperature distribution inside the climatic chambers (5) calibration of the 3 sensors at 7 different temperature levels (6) yearly calibration including full-risk maintenance (7) used for monitoring the environmental conditions of the room where micropipettes are calibrated PS ph-meters have not been included in the comparison, because already now they are calibrated / verified by the KFVL personnel 18

99 Annex no. 6a: tentative list of Kosovo major diseases, for which specific diagnostic procedures must be in place in KFVL Oie Listed of Notifiable Diseases (2015) RKS Veterinary Notifiable Law diseases(1) 19 Eu regulations Sanitary controls(2) Breeding animals(3) Zoonosis Tentative List of RKS Major Diseases(4) Multiple species diseases, infections and infestations Anthrax X X X X Bluetongue X X X X X Brucellosis (Brucella abortus) X X X X X X Brucellosis (Brucella melitensis) X X X X X X Brucellosis (Brucella suis) X X X(o) X X X Crimean Congo haemorrhagic fever X X Epizootic haemorrhagic disease --- Equine encephalomyelitis (Eastern) X --- Foot and mouth disease X X X Heartwater --- Infection with Aujeszky's disease virus X(o) X X Infection with Echinococcus granulosus X --- Infection with Echinococcus multilocularis X --- Infection with rabies virus X X X X Infection with Rift Valley fever virus X X X --- (unlikely) Infection with rinderpest virus X X --- (unlikely) Infection with Trichinella spp. X X X Japanese encephalitis X --- New world screwworm (Cochliomyia hominivorax) --- Old world screwworm (Chrysomya bezziana) --- Paratuberculosis --- Q fever X X Surra (Trypanosoma evansi) (X) --- Tularemia X --- West Nile fever X(4) X X Cattle diseases and infections Bovine anaplasmosis --- Bovine babesiosis X Bovine genital campylobacteriosis X X Bovine spongiform encephalopathy X X X X X Bovine tuberculosis X X X X X X Bovine viral diarrhoea X X Enzootic bovine leukosis X X X X X Haemorrhagic septicaemia --- Infectious bovine rhinotracheitis X(o) X X Infection with Mycoplasma mycoides subsp. mycoides X X --- (unlikely) Lumpy skin disease X X X Theileriosis --- Trichomonosis X X Trypanosomosis (tsetse-transmitted) X --- Sheep and goat diseases and infections Caprine arthritis/encephalitis X Contagious agalactia --- Contagious caprine pleuropneumonia --- Infection with Chlamydophila abortus (Enzootic abortion of ewes) X X Infection with peste des petits ruminants virus X X X Maedi-Visna X Nairobi sheep disease (X) --- Ovine epididymitis (Brucella ovis) X X Salmonellosis (S. abortusovis) --- Scrapie X X X X Sheep pox and goat pox X X X Equine diseases and infections Contagious equine metritis X --- Dourine --- Equine encephalomyelitis (Western) X(4) X --- Equine infectious anaemia X --- Equine influenza --- Equine piroplasmosis --- Glanders --- Infection with African horse sickness virus X X --- (unlikely) Infection with equid herpesvirus-1 (EHV-1) --- Infection with equine arteritis virus X --- Venezuelan equine encephalomyelitis X(5) X ---

100 Oie Listed of Notifiable Diseases (2015) RKS Veterinary Notifiable Law diseases(1) Eu regulations Sanitary controls(2) Breeding animals(3) Zoonosis Tentative List of RKS Major Diseases(4) Swine diseases and infections African swine fever X X X Infection with classical swine fever virus X X X X Nipah virus encephalitis X --- Porcine cysticercosis X --- Porcine reproductive and respiratory syndrome --- Transmissible gastroenteritis X(o) --- Avian diseases and infections Avian chlamydiosis X(6) X --- Avian infectious bronchitis --- Avian infectious laryngotracheitis --- Avian mycoplasmosis (Mycoplasma gallisepticum) --- Avian mycoplasmosis (Mycoplasma synoviae) --- Duck virus hepatitis --- Fowl typhoid --- Avian influenza (poultry) X X X HPAI A viruses in birds other than poultry X X X Infection with Newcastle disease virus X X X Infectious bursal disease (Gumboro disease) --- Pullorum disease --- Turkey rhinotracheitis --- Lagomorph diseases and infections Myxomatosis X(o) --- Rabbit haemorrhagic disease X(o) --- Other diseases and infections --- Camelpox --- Leishmaniosis X X Bee diseases, infections and infestations Melissococcus plutonius (European foulbrood) X(o) X Paenibacillus larvae (American foulbrood) X X Infestation of honey bees with Acarapis woodi X(o) X Infestation of honey bees with Tropilaelaps spp. X X Varroa spp. (Varroosis) X(o) X Aethina tumida (Small hive beetle) X X Other animal species Fish diseases Epizootic haematopoietic necrosis X Infectious haematopoietic necrosis X X Spring viraemia of carp X Viral haemorrhagic septicaemia X Other diseases (here non listed) ---- Mollusc diseases Although including some EU-notifiable diseases, since --- Crustacean diseases these diseases are not relevant for Kosovo, they are not --- Amphibians included in the tentative major diseases list --- Other diseases (not present in the OIE list) Aleutian disease (mink) X(o) --- Border Disease (rams, bucks) X X Ebola (non-human primates) X X --- Campylobacter spp (poultry) X X(i) Monkey pox (Rodentia and non.human primates) X X --- Nosema spp (bees) X(i) Porcine Enterovirus Encephalomyelitis (pigs) X --- Scabies X --- Salmonella spp (poultry) X X(i) Swine Vesicular Disease (pigs) X X X Toxoplasmosis X X(i) Tularemia (Lagomorphs) X(o) X --- Vesicular Stomatis (Ruminants, Equines) X X --- (unlikely) Viral Enteritis (mink) X(o) --- (1) EU-notifiable diseases basing (mainly) on the following provisions - Directive 1964/432 annex E(I) - Directive 1990/425 annex C - Directive 1992/65 annex A (2) EU-compulsory[X] or EU-optional[X(o)] officially recognized programmes basing (mainly) on the following provisions - Directive 1964/432 (cattle, swine) - Directive 1991/68 (small ruminants) - Directive 1992/65 annex B (other species) - Regulation 2001/999 (BSE, scrapie) - Regulation 2007/1266 (Bluetongue (3) EU-compulsory controls on breeding animals basing (mainly) on the following provisions - Directive 1988/407 (bulls) - Directive 1992/65 (stallions, boars, rams, bucks) - Regulation 2007/1266 (Bluetongue, ruminants) (4) X(i) included in the list on KFVA s request (5) According to Directive 1990/425, Viral Equine Encephalomyelitis is notifiable (subject to mandatory emergency actions); for this reason, in the table all equine viral encephalomyelitis have been classified as notifiable (6) Only Psittacosis is EU-notifiable (in Psittaciformes) 20

101 Annex no. 6b: tentative list of Kosovo major diseases, for which specific diagnostic procedures must be in put place in KFVL Disease (OIE list 2015) Multiple species diseases, infections and infestations Anthrax Bluetongue Brucellosis (Brucella abortus) Brucellosis (Brucella melitensis) Brucellosis (Brucella suis) Crimean Congo haemorrhagic fever Foot and mouth disease Aujeszky's disease Rabies Infection with Trichinella spp. Q fever West Nile fever Cattle diseases and infections Bovine Babesios Bovine genital campylobacteriosis Bovine spongiform encephalopathy Bovine tuberculosis Bovine viral diarrhoea Enzootic bovine leukosis Infectious bovine rhinotracheitis Lumpy skin disease Trichomonosis Sheep and goat diseases and infections Caprine arthritis/encephalitis Enzootic abortion of ewes (Chlamydophila abortus) Infection with peste des petits ruminants virus Maedi-Visna Ovine epididymitis (Brucella ovis) Scrapie Sheep pox and goat pox Swine diseases and infections African swine fever Classical swine fever Avian diseases and infections Avian Influenza HPAI A viruses in birds other than poultry Newcastle disease Other diseases and infections Leishmaniosis Bee diseases, infections and infestations Melissococcus plutonius (European foulbrood) Paenibacillus larvae (American foulbrood) Infestation of honey bees with Acarapis woodi Infestation of honey bees with Tropilaelaps sp Varroa spp. (Varroosis) Aethina tumida (Small hive beetle) Fish diseases Epizootic haematopoietic necrosis Infectious haematopoietic necrosis Spring viraemia of carp Viral haemorrhagic septicaemia Other diseases (not present in the OIE list) Border Disease (small ruminants) Campylobacter spp (poultry) Nosema spp (bees) Salmonella spp (poultry) Swine vesicular disease (swine) Toxoplasmosis (multiple species) Comments EU-Notifiable Zoonosis EU-Notifiable EU-regulated relevant for breeding animals EU-Notifiable Zoonosis EU-regulated relevant for breeding animals EU-Notifiable Zoonosis EU-regulated relevant for breeding animals EU-Notifiable Zoonosis EU-regulated relevant for breeding animals Zoonosis present in the Balkan area EU-Notifiable EU-regulated relevant for breeding animals EU-Notifiable Zoonosis present in Europe Zoonosis present in Europe Zoonosis present in Europe EU-Notifiable Zoonoosis present in Europe KFVA s request Relevant for breeding animals EU-Notifiable Zoonosis EU-regulated EU-Notifiable EU-regulated Zoonosis - relevant for breeding animals Relevant for breeding animals EU-Notifiable EU-regulated relevant for breeding animals EU-regulated relevant for breeding animals EU-Notifiable Risk of introduction from Middle East / Turkey Relevant for breeding animals KFVA s request Zoonosis EU-Notifiable KFVA s request EU-Notifiable Relevant for breeding animals EU-Notifiable EU-Notifiable EU-Notifiable Risk of introduction from eastern Europe EU-Notifiable EU-Notifiable EU-Notifiable EU-Notifiable Zoonosis EU-regulated EU-Notifiable EU-regulated EU-Notifiable EU-regulated EU-Notifiable KFVA s request EU-Notifiable KFVA s request KFVA s request Relevant for breeding animals (Small Ruminant) Zoonosis KFVA s request KFVA s request Zoonosis KFVA s request EU-Notifiable Risk of introduction from Italy Zoonosis - KFVA s request 21

102 Annex no. 6c: tentative list of Kosovo major diseases, for which specific diagnostic procedures must be in put place in KFVL Disease Present in Kosovo KS Schedule 1 EU Notifiable EU regulated 22 EU Breeding Zoonosis Primary surveillance Active surveillance Priority Ab detection Lab tests required Aetiological agent detection Multiple species diseases, infections and infestations Anthrax Y Y Y Y High /// Microscopy/PCR Bluetongue Y Y Y Y Y High ELISA PCR Brucellosis (Brucella abortus)? Y Y Y Y Y High RBT/CFT/ELISA Culture Brucellosis (Brucella melitensis) Y Y Y Y Y Y High RBT/CFT/ELISA Culture Brucellosis (Brucella suis) Y Y Y Y RBT/CFT/ELISA Culture Crimean Congo haemorrhagic fever Y Y ELISA PCR Foot and mouth disease Y Y High ELISA PCR Aujeszky's disease Y Y ELISA PCR Rabies? Y Y Y High ELISA IFAT/PCR Infection with Trichinella spp.? Y Y - ++ High ELISA Microscopy Q fever Y Y ELISA PCR West Nile fever Y Y ELISA PCR Cattle diseases and infections Bovine Babesiosis ELISA Microscopy/PCR Bovine genital campylobacteriosis Y - ++(bulls) /// Culture Bovine spongiform encephalopathy Y Y Y Y High /// ELISA Bovine tuberculosis Y Y Y Y Y Y High Skin test /// Bovine viral diarrhoea Y ELISA PCR Enzootic bovine leukosis Y Y Y Y - ++ High ELISA /// Infectious bovine rhinotracheitis Y Y ELISA PCR Lumpy skin disease Y Y High /// PCR Trichomonosis Y - +++(bulls) /// Microscopy/Culture Sheep and goat diseases and infections Caprine arthritis/encephalitis? (Y) (High) ELISA PCR Enzootic abortion of ewes (Chlamydophila abortus) Y ELISA PCR Infection with peste des petits ruminants virus Y High ELISA PCR Maedi-Visna? (Y) (High) ELISA PCR Ovine epididymitis (Brucella ovis) Y (rams) CFT/ELISA /// Scrapie Y High /// ELISA Sheep pox and goat pox Y High /// PCR Swine diseases and infections African swine fever Y Y High ELISA PCR Classical swine fever? Y Y High ELISA PCR Avian diseases and infections Avian Influenza (HPAI and LPNAI) Y Y High HI/ELISA PCR, Rapid test HPAI A viruses in birds other than poultry Y Y High HI/ELISA PCR, Rapid test Newcastle disease? Y Y High HI/ELISA PCR Other diseases Leishmaniosis Y ++ - IF ///

103 Disease Present in Kosovo KS Schedule 1 EU Notifiable EU regulated EU Breeding Zoonosis Primary surveillance Active surveillance Priority Ab detection Lab tests required Aetiological agent detection Bee diseases, infections and infestations Melissococcus plutonius (European foulbrood) Y (High) /// Culture Paenibacillus larvae (American foulbrood) Y Y (High) /// Culture Infestation of honey bees with Acarapis woodi Y (High) /// Microscopy Infestation of honey bees with Tropilaelaps spp Y (High) /// Microscopy Varroa spp. (Varroosis) Y (High) /// Microscopy Aethina tumida (Small hive beetle) Y (High) /// Microscopy Fish diseases Epizootic haematopoietic necrosis /// ELISA/PCR Infectious haematopoietic necrosis Y Y /// IFAT/PCR Spring viraemia of carp /// IFAT/PCR Viral haemorrhagic septicaemia /// IFAT/PCR Other diseases (not present in the OIE list) Border Disease (small ruminant) Y - ++(rams) ELISA PCR Campylobacter spp (poultry) Y Y - - /// Culture Nosema spp (bees) (High) /// Microscopy/PCR Salmonellosis spp (poultry) Y - - /// Culture Swine vesicular disease (swine) Y Y High ELISA PCR Toxoplasma (multiple species) Y Y ELISA PCR KS SCHEDULE 1 List of the notifiable diseases according to the Kosovo Veterinary Law 2004/21. Diseases for which the indication (Y) is given are not notifiable, but their inclusion in the list is suggested by KAHL. PRIMARY/ACTIVE SURVEILLANCE For each disease, columns are filled according to the actual significance of each kind of surveillance (not according to what currently is being done by the RKS veterinary services). PRIORITY All the diseases listed as notifiable (according to the Kosovo Veterinary Law 2004/21) have been classified as high priority diseases, except for those which are very unlikely to occur on Kosovo (for this reason they have not been included in the major diseases list). Diseases for which the indication (High) is given are not notifiable, but their inclusion in the high-priority disease list is suggested by KAHL. LAB TEST REQUIRED Lab tests are listed which are already in use / eligible to be introduced in the KFVL; e.g., in the case of FMD/SVD or Classical/African Swine Fever the virus isolation on cell cultures has not been mentioned due to the biosafety requirements which are required as well as to the technical difficulties linked to the maintenance of cell cultures; this specific lab procedures have to be outsourced to NRLs of foreign countries. As a general rule, it has been agreed with KFVL that procedures based on cell culture / embryonated eggs should not be taken into account. About the CFT and HI tests: no doubt about their usefulness (in particular for Brucella and Avian Influenza antibody detection), but the feasibility of a regular supply of fresh erythrocytes has to be assessed. 23

104 Annex no. 7a: excerpt of the main legal provisions cited in annex no. 6a EU-notifiable disease Dir. 1964/432 ANNEX E (I) (a) Bovine diseases Foot-and-mouth disease Rabies Tuberculosis Brucellosis Contagious bovine pleuropneumonia Enzootic bovine leukosis Anthrax (b) Swine diseases Rabies Brucellosis Classical swine fever African swine fever Foot-and-mouth disease Swine vesicular disease Anthrax 24

105 Annex no. 7b: excerpt of the main legal provisions cited in annex no. 6a EU-notifiable disease Dir. 1990/425 ANNEX C LIST OF DISEASES OR EPIZOOTIC DISEASES, SUBJECT TO MANDATORY EMERGENCY ACTION, WITH TERRITORIAL RESTRICTIONS (MEMBER STATES, REGIONS OR ZONES) Foot and mouth disease (FMD) Classical swine fever (CSF) African swine fever (ASF) Swine vesicular disease (SVD) Newcastle disease (ND) Rinderpest Peste des petits ruminants (PPR) Vesicular stomatitis (VS) Blue tongue African horse sickness (AHS) Viral equine encephalomyelitis Teschen disease Avian influenza Sheep and goat pox Lumpy skin disease Rift valley fever Contagious bovine pleuropneumonia 25

106 Annex no. 7c: excerpt of the main legal provisions cited in annex no. 6a EU-notifiable disease Dir. 1992/65 ANNEX A Notifiable diseases in the context of this Directive Disease African horse sickness African swine fever Avian influenza American foulbrood Anthrax Bluetongue Brucella abortus Brucella melitensis Brucella ovis Brucella suis Classical swine fever Contagious bovine pleuropneumonia Ebola Foot-and-mouth disease Infectious haematopoeitic necrosis Lumpy skin disease Monkey pox Mycobacterium bovis Newcastle disease Peste des petits ruminants Porcine enterovirus encephalomyelitis Psittacosis Rabies Rift valley fever Rinderpest Small hive beetle(aethina tumida) Sheep and goat pox Swine vesicular disease Tropilaelaps mite (Tropilaelapsspp). Vesicular stomatitis TSE Equidae Suidae andtayassuidae Aves Apis Order/family/species primarily concerned Bovidae, Camelidae, Cervidae, Elephantidae, Equidae and Hippopotamidae Antilocapridae, Bovidae, Cervidae, Giraffidae, and Rhinocerotidae Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae andtragulidae Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae andtragulidae Camelidae, Tragulidae, Cervidae, Giraffidae, Bovidae and Antilocapridae Cervidae, Leporidae, Ovibos moschatus, Suidae andtayassuidae Suidae andtayassuidae Bovines (including zebu, buffalo, bison and yak) Non-human primates Artiodactyla and Asian elephants Salmonidae Bovidae andgiraffidae Rodentia and non-human primates Mammalia, in particularantilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, and Tragulidae Aves Bovidae and Suidae Suidae Psittaciformes Carnivora and Chiroptera Bovidae, Camelusspecies andrhinocerotidae Artiodactyla Apis and Bombus Bovidae Suidae andtayassuidae Apis Artiodactyla andequidae Bovidae, Cervidae, Felidae and Mustelidae 26

107 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex H Report of the SSTE Information Technology Consortium Agrotec SpA / NIRAS / IZSVe 35

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109 KOSOVO FOOD AND VETERINARY AGENCY Technical assistance for the Animal Health Department of the KFVA and the Food and Veterinary Laboratory MISSION REPORT (23 rd March 3 rd April 2015) Of Information Technology Expert April 2015

110 ABBREVIATIONS AND ACRONYMS BIP CEO COTS EU I&R ISO IT ISP JSTE KE KVFA LAN LIMS PC PVTP SaaS SSTE TA ToR VIS WD Border Inspection Post Chief Executive Officer Commercial Off-The-Shelf European Union Identification and Registration International Organization for Standardization Information Technology Internet Service Provider Junior Short Term Expert Key Expert Kosovo Veterinary and Food Agency Local Area Network Laboratory Information Management System Personal Computer Private Veterinary Practitioner Software As-A-Service Senior Short Term Expert Technical Assistance Terms of Reference Veterinary Information System Working Day

111 TABLE OF CONTENTS Abbreviations and acronyms... 2 Table of contents... 3 Introduction... 3 Laboratory Information Management System... 3 Current situation... 3 LIMS proposal... 5 LIMS development methodology... 5 Comparison of in-house and outsourced software development approaches... 6 Open source LIMS... 7 One time activities... 8 Review of ToR for the development of I&R software... 8 Time plan of missions... 8 List of meetings / Itinerary... 9 ANNEX List of KFVA laboratory instruments and staff INTRODUCTION Senior Short Term Expert s (SSTE) on Information Technology (IT) first mission to Pristina was carried out between 23 rd of March and 3 rd of April of Ten working days (WD) were implemented during the time period. During the mission IT expert worked together with Team Leader, Key Expert 2, Communications Expert, Livestock Economist and government representatives from the Kosovo Food and Veterinary Agency (KFVA). SSTE on IT is directly involved in achieving of the project result 11 Laboratory management systems including document management and communications system have been reviewed and updated. Result 11 is further subdivided into 3 deliverables: - D11.1 A detailed report of the assessment of the current status of the management systems of Food and veterinary Laboratory - D11.2 A detailed proposal for a revised and streamlined management system for the KFVA Food and Veterinary Laboratory - D11.3 A financial strategy to match the available budget to the cost of the upgrade of the laboratory management system of the KFVA Food and Veterinary Laboratory During the first mission most efforts were aimed at achieving D11.1. In addition the beneficiary has requested SSTE on IT to review a draft ToR for the development of the I&R system. Initially the technical offer envisaged 80 working days for the Junior Short Term Expert (JSTE) on IT. After reviewing project results and deliverables it was decided together with the Team Leader to shift the 80 WD to the pool of unallocated time. LABORATORY INFORMATION MANAGEMENT SYSTEM CURRENT SITUATION On 24th of March SSTE on IT met with the Head of KFVA Laboratory Dr Bafti Murati and the IT Officer of KFVA Mr Nazmi Collaku. The aim of the meeting was to

112 describe the current situation at the KFVA laboratory. The KFVA laboratory consists of six sectors: - Microbiology - Bacteriology - Serology - Food microbiology - Food chemistry - Milk analysis There are 30 staff working at the laboratory. The laboratory is equipped with around 20 personal computers (PC) running Microsoft operating system. The computer hardware in the laboratory is 5-10 years old and out of warranty. The website of the laboratory is incorporated into the KFVA website at Laboratory computers are a connected to the KFVA Local Area Network (LAN). There is no firewall separating the laboratory network from the rest of the agency. The computer users at the laboratory have basic knowledge level in computers, enabling them to work with office suite software, communicating with s and browse Internet. User support and maintenance is provided by the KFVA IT Officer Mr Nazmi Collaku. The following types of analytical testing instruments are directly connected to PCs and are using specialized software: - ELISA readers - PCR somatic cell counters - HPLC - Soleris - Foodscan - Spectrophotometer - GC/MSD - Bactoscan - Milkoscan - Fossomatic Minor - Colony doc-it For full list of KFVA laboratory equipment please have a look at annex List of KFVA laboratory instruments and staff. The list was prepared by IT Officer of KFVA Mr Nazmi Collaku. At the moment information management processes at the KFVA laboratory are based on using paper. SSTE on IT was introduced to the attempt at developing a Laboratory Information Management System (LIMS) for the KFVA laboratory using an in-house software developer. Under the leadership of the previous laboratory director a local software developer was employed. His task was to design a LIMS according to the specific requirements of the KFVA Laboratory. The developer has since finished his cooperation with the laboratory but unfortunately the system implementation was not achieved and no data has been entered. In current state the software is unusable. The SSTE on IT suggested that the developer should be contacted and the

113 possibility of finalizing the work should be discussed. At this stage it looks improbable that the system is going to work. LIMS PROPOSAL During the next mission of SSTE on IT together with Key Expert (KE) Dr Stefano Nardelli and government counterparts a proposal document for a new LIMS will be compiled. The design document will follow the criterions defined by ISO and it will include the necessary document management functions. Direct interfaces with the analytical testing instruments will be included in the proposal. Estimated cost of LIMS will be also specified in the proposal. The estimated amount will be aggregated from the costs for hardware, licenses, customization, localization, training and maintenance. On 2 nd of April SSTE on IT together with KE Dr Stefano Nardelli met with the Head of KFVA Laboratory Dr Bafti Murati, the IT Officer of KFVA Mr Nazmi Collaku and with Quality Manager of KFVA Ms Fillojete Rrustemaj. The aim of the meeting was to discuss development of LIMS proposal. It was agreed that Ms Fillojete Rrustemaj will be the contact person for the LIMS technical design preparation. SSTE on IT was informed that KFVA laboratory has applied for a euro budget for the development of LIMS and is expecting to receive the official approval for the amount by July It is therefore appropriate to plan for the next mission of SSTE on IT to take place around that time. As a result LIMS technical design document will be ready in time. The LIMS proposal will explain the following topics: - sample flow diagram in the laboratory - specification of integrated laboratory instruments - bar-coding requirement - integration with other information systems at KFVA - training needs Different options for LIMS development will be outlined: an option to procure Commercial Off-The-Shelf (COTS) LIMS, freeware or open-source LIMS option and Software As-A-Service (SaaS) LIMS. Additionally the LIMS software could be developed from scratch to meet the specific requirements of KFVA laboratory. The development can be outsourced to a software developing company or managed inhouse. In-house development approach is a process whereby the organization s own staff (in-house team) develops the IT systems. By contrast outsourced software development approach describes the procurement of the IT systems from outside vendors. LIMS DEVELOPMENT METHODOLOGY The general criterions for LIMS software solution are: - fulfilment of local requirements - user acceptance - optimising costs

114 - minimising risks - safeguarding of investment The future KFVA laboratory LIMS should be open for future developments and prepared to be linked with other systems. The solution must be adapted to specific requirements of Kosovo. The user acceptance of the LIMS is assured if they benefit from the use of the system, also if the system is easy to use and always available. The following costs will need to be accounted for: - one time start-up costs of hardware, software and infrastructure - continuous operating costs namely maintenance, staffing and telecommunication Investment safeguarding of LIMS is achieved through: - modern system design - readiness of the system to meet new requirements - extensibility of the system towards new technologies - favouring of standard solutions versus unique solutions - independence from a particular software developer or vendor Proposed methodology for deciding on a LIMS software consists of the following steps: - establish user requirements - prepare functional design - develop or procure the system - test the system - provide training - provide continuous support and maintenance COMPARISON OF IN-HOUSE AND OUTSOURCED SOFTWARE DEVELOPMENT APPROACHES When developing IT systems there is a choice between in-house development approach and outsourced software development approach. The following are the advantages of in-house development: - organization will have full ownership of the system (its source code and the knowledge gained while developing it) - the software will be tailored exactly to the business requirements of the organization - the relationship between the development team and the software users is very close which should result in excellent communication - organization retains full control over the system and its functionality - no need to pay for costs like licensing fees, installation, localization and user training - the development costs correspond to local market prices - cultural misunderstandings and translation problems are eliminated - not dependent on a specific software supplier The following are the disadvantages of in-house development:

115 - in-house development is usually more expensive than outsourcing; especially if software development is not one of the core functions of the organization - for extended time period the organization will need to commit to setting up and maintaining a software development unit and the relevant infrastructure - the organization will bear the risks of cost and development time overruns (studies have shown that around 75% of IT development projects go over budget and/or do not meet the time deadline) - for governmental organization it might prove to be difficult to offer competitive remuneration to highly skilled software developers - if there is a COTS alternative available then the in-house IT systems development is usually much more time consuming - providing a long-term full-time work for the in-house development team could be a challenge OPEN SOURCE LIMS By and large open source software is a program whose source code is made available for use and modification. There are a number of open source LIMS available, some of them are listed below: - Bika, - calims, - LabKey, - openclinica, - Labmatica, - Science Lab Inventory & Order Management, - FlowLIMS, - Open-LIMS, - OpenElis, More information about open source LIMS can be found at The most proven examples of the open source LIMS are being used by hundreds of organizations and have been developed for more than 10 years, are ISO ready, contain document management functionality and are web-based needing only a thin client. During the mission SSTE on IT together with KE2 conducted a limited trial of Bika LIMS. Brucellosis testing workflow was successfully implemented using the opensource LIMS. SSTE on IT suggested to the KFVA lab to conduct a similar trial of a freely available open source LIMS. By trialing the open source LIMS the laboratory can substantially improve their understanding of LIMS possibilities.

116 ONE TIME ACTIVITIES During the first mission the SSTE on IT was engaged in following one time activities: - Review of the ToR for the development of web-based I&R software - Comments provided to the INSTRUMENT FOR PRE-ACCESSION ASSISTANCE (IPA II) document - A calendar tool has been set in order to publish KAHL project activities on Internet. The calendar is accessible to project team at: 40group.calendar.google.com REVIEW OF TOR FOR THE DEVELOPMENT OF I&R SOFTWARE On 23 rd of March SSTE on IT met with the Head of I&R Section Mr Sadik Heta and the IT Officer of KFVA Mr Nazmi Collaku. The aim of the meeting was to review the IT components of the existing I&R system and discuss the plans for future. Since 2010 InterTrace software has been implemented as the I&R data management system. Server hardware currently used for I&R was installed in The old hardware will be replaced with the new server in the coming months. KFVA has identified new functions for the I&R software and is planning for a major upgrade. For the current fiscal year KFVA has budgeted around euros for the I&R software development. SSTE on IT was given a copy of the draft ToR for the development of I&R software and asked to provide his comments. On 31 st of March SSTE on IT met with the Head of I&R Section Mr Sadik Heta and conveyed his opinion regarding the draft ToR for the development of I&R software. Main observations are: - It is necessary to include a detailed time plan (ie project duration, allowed time for system design, development, testing, deployment, support and maintenance) - Reporting requirements should be described (ie, Inception Report, Design Specification, Testing Report, Training Report) - Existing I&R system should be fully explained to the contractor (manual of I&R procedures and I&R forms) - The ToR should specify the transition from the existing I&R system to the new version (existing functions that will be kept unchanged in the new system, similarly functions that will be removed or modified) - List of interfaces to other systems (for example to LIMS, VIS, etc) TIME PLAN OF MISSIONS The total input of SSTE on IT is 20 working days (WD), divided into two missions. The below table describes missions of SSTE on IT. Nr Mission start Mission length Description of work/activities Comments 1 March/April WD Support to the preparation of Inception Report Accomplished

117 2 July WD Activities according to Project Plan To be delivered Total of 20 WDs and 2 missions LIST OF MEETINGS / ITINERARY Date Event Travel Tartu-Tallinn-Istanbul Travel Istanbul-Pristina Kick-off meeting with Team Leader Meeting with the Head of Animal Health and Welfare Directorate of KFVA Meeting with the Head of I&R Section Meeting with the Chief Executive Officer (CEO) of KFVA Meeting with the Head of Animal Health and Welfare Directorate of KFVA Meeting with the Head of KFVA laboratory and IT Officer of KFVA Meeting with TL to discuss the Inception Report Meeting with TL to discuss the Inception Report Meeting with the Head of I&R Section Report writing Meeting with the Head of I&R Section Report writing Meeting with the Head of KFVA laboratory and IT Officer of KFVA Meeting with the Head of Animal Health and Welfare Directorate of KFVA Report writing Travel Pristina-Istanbul Travel Istanbul-Tallinn-Tartu

118 ANNEX LIST OF KFVA LABORATORY INSTRUMENTS AND STAFF Laboratory Devices has own program Staff Serology and molecular diagnostic Elisa yes PCR yes 3 Elisa yes Bacterology,mycology and parasitology PCR yes 2 Pathalogy and pathohistology TICSSUE PROCESOR manualy manualy 1 Soleris yes Food Microbiology Colony doc-it yes 5 Incubator manualy Elisa yes charm yes hplc yes Food chemistry and veterinary residues foodscan yes 9 spectrophotometer yes gcmsd yes hlpl\lcms yes Bactoskan(2) yes Raw milk analasys Milkoscan yes 3 Fosomatic yes Sample reception/veterinary 2 Sample recepiton/food 2 Director 1 Quality manager 1 Director assistant 1 30

119 Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Inception Report (Final)- Annex I Report of the SSTE Communications and Media Consortium Agrotec SpA / NIRAS / IZSVe 36

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121 Technical Assistance for the Animal Health Department of the KFVA and the Food and Veterinary Laboratory EuropeAid/133795/DH/SER/XK EUROPEAN UNION The European Union IPA 2013 programme for Kosovo REPUBLIC OF KOSOVO Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) EuropeAid/133795/DH/SER/XK Mission Report Senior short term communication expert Mission 01 March 2015 A project implemented by the Consortium Agrotec SpA / NIRAS / IZSve This project is funded by the European Union Short term senior expert on communication Mission Report Apr-15 1 / 7