Final Report - Moldova Assessment
Transcription
Final Report - Moldova Assessment
TECHNICAL ASSESSMENT REPORT Moldova Assessment of the national communicable disease surveillance and response systems 2014 TECHNICAL ASSESSMENT REPORT Moldova - Assessment of the national communicable disease surveillance and response systems 2014 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page ii of 95 Acknowledgements The internal and national review team acknowledges with gratitude the full and professional collaboration of respondents at all levels of the Moldova communicable diseases system. The support of TAIEX and the Romania National Institute of Public Health, and the WHO Regional Office for Europe WHO Europe and WHO Collaborating Centre for HIV surveillance in Zagreb, Croatia in enabling the participation of Drs Popovici and Bozicevic, respectively, is gratefully acknowledged. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page iii of 95 Contents Abbreviation ..................................................................................................................v Executive Summary ....................................................................................................... 1 1 Introduction .......................................................................................................... 6 1.1 1.2 1.3 1.4 2 Background .........................................................................................................................6 Assessment Methodology .................................................................................................6 Country profile ...................................................................................................................7 Health systems profile ....................................................................................................10 Surveillance ......................................................................................................... 16 2.1 Surveillance objectives, legislative framework ............................................................16 2.2 Identification and reporting of diseases under surveillance .....................................17 2.3 Data processing, analysis by the Public Health Centres ............................................18 2.4 Reporting and feedback..................................................................................................19 2.5 Outbreak recognition, management, investigation and reporting ...........................19 2.6 Data protection, data access .........................................................................................21 2.7 Parallel Disease specific surveillance systems .............................................................21 2.8 Other surveillance systems ............................................................................................23 2.9 System sensitivity and specificity ..................................................................................23 2.10 System coordination and integration ............................................................................24 2.11 International reporting and potential for case reporting to EU level.......................26 2.12 System monitoring and evaluation ...............................................................................26 Surveillance and Outbreaks: strengths and weaknesses ......................................................28 Component S1: Legislative and regulatory framework ........................................................28 Component S2: Surveillance information systems ................................................................31 Component S3: Use of surveillance information system .....................................................33 Component S4: Disease specific programmes and surveillance .........................................35 Component S5: Public health workforce ................................................................................38 Component S6: Support to wider health service ..................................................................40 3 Public Health Microbiology System .......................................................................... 41 3.1 System Overview .............................................................................................................41 3.2 Primary diagnostic laboratory services .........................................................................41 3.3 Reference microbiological diagnostic services ............................................................42 3.4 Laboratory activity reporting..........................................................................................44 3.5 Integration with surveillance systems and other sectors ..........................................44 3.6 Integration with alert and response systems ..............................................................45 3.7 Laboratory regulation and standards ...........................................................................46 3.8 Training and continuing education microbiologists and technical staff ..................47 Public health Microbiology: strengths and weaknesses.........................................................48 Component L1: Primary diagnostic laboratory services ......................................................48 Component L2: Reference microbiological diagnostic services ..........................................49 Component L3: Laboratory service quality ............................................................................51 Component L4: Inter-professional and inter-sectoral collaboration ..................................52 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 4 Page iv of 95 Public Health Emergency Preparedness, Response and Crisis Management ................... 53 4.1 Systems Overview ...........................................................................................................53 4.2 Past crises and potential threats ...................................................................................53 4.3 Management of Public Health emergencies ................................................................54 4.4 Regulatory basis ..............................................................................................................54 4.5 Strategic and Coordinating Bodies ................................................................................55 4.6 Early warning and communications ..............................................................................56 4.7 Training .............................................................................................................................57 4.8 Summary ...........................................................................................................................57 Public health emergency preparedness: strengths and weaknesses ..................................58 Component P1: Regulatory and strategic basis ....................................................................58 Component P2: Emergency preparedness and response organisation .............................59 Component P3: Emergency preparedness planning .............................................................60 Component P4: Preparedness and response operations .....................................................62 Component P5: Monitoring and evaluation ............................................................................64 Annexes ..................................................................................................................... 65 Annex 1. Annex 2. Annex 3. Prevention Annex 4. Annex 5. International and National Review Teams, and National Respondents ..........66 Terms of Reference and Itinerary .........................................................................67 Principal Legislation, Decisions, Orders relating to Communicable Disease and Control in Republic of Moldova ......................................................................73 List of reportable diseases, syndromes, events. .................................................81 Health Emergency Response Organisations ........................................................85 Maps & figures Figure Figure Figure Figure Figure 1 2 3 4 5 - Republic of Moldova: administrative divisions .....................................................................8 Organisation of the health system, Republic of Moldova. ...............................................11 Organisational chart of the Ministry of Health, Republic of Moldova .............................12 Organisational chart National Centre Public Health ..........................................................13 Public health emergencies organisational structure, Republic of Moldova. ..................56 Tables Table 1 - List of recommendations ..........................................................................................................4 Table 2 - Economic indicators, Republic of Moldova, 2011 .................................................................9 Table 3 - Health Indicators, Republic of Moldova ...............................................................................10 Table 4 - Reported confirmed disease rates from surveillance systems, for selected diseases, Republic of Moldova, compared with EU/EEA Member States (mean crude rate), 2012 ..............25 Table 5 - Most significant natural disasters occurring in the Republic of Moldova in terms of death and population affected, 1990–2014 .........................................................................................53 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page v of 95 Abbreviation BSL Biosafety level CCHF Crimean-Congo haemorrhagic fever CLSI Clinical and Laboratory Standards Institute CPESS Civil Protection and Exceptional Situations Service CPH Centre for Public Health CSP Conferinţa ştiinţifico-practică DV Dermato-venereology ECDC European Centre for Disease Prevention and Control EARS Early Aberration Reporting System EMAS Emergency Medical Assistance Service EU European Union EUCAST European Committee on Antimicrobial Susceptibility Testing GAVI Global Alliance for Vaccines and Immunisation GDP Gross domestic product GIS Geographic information systems GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria HDI Human Development Index HIV/AIDS Human immunodeficiency virus infection and acquired immune deficiency syndrome IBBS Bio-behavioural surveillance survey ICD International Classification of Disease IHR International Health Regulations MediPIET Mediterranean Programme for Intervention Epidemiology Training MoH Ministry of Health NCPH National Centre for Public Health NIHC National Health Insurance Company NIPP National Tuberculosis Institute NRL National reference laboratory NSPCEM National Scientific and Practical Centre of Emergency Medicine PCR Polymerase chain reaction PHC Public Health Centres PHS Public Health service RCDM Centre for Disaster Medicine SAE Electronic surveillance system SAQ Self-administered questionnaire SOP Standard Operating Procedure STD Sexually transmitted diseases STI Sexually transmitted infections TAIEX Technical Assistance and Information Exchange instrument TB Tuberculosis TESSy The European Surveillance System ToR Terms of Reference USSR Union of Soviet Socialist Republics VETC/STEC Vero /Shiga toxin- producing Escherichia coli WHO Europe World Health Organisation Regional Office for Europe WNV West Nile Virus TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 1 of 95 Executive Summary Background Communicable disease surveillance and response systems in the Republic of Moldova have undergone substantial development from the Shemasko system inherited on independence in 1991, and in the context of repeated reforms of government administration, healthcare services and public health structures. A major review by WHO in 2001 1 provided significant impetus and strategic direction to the reform and development of the surveillance system. Recent years have seen substantial developments in the legislative and strategic frameworks relating to communicable disease prevention and control, and in technical and design elements of the surveillance and early warning systems. A major strategic focus over this period has been the decision to align systems as compatible with those of European Union countries. In 2014 Moldova entered into a Partnership Agreement with the European Union. The present review was requested by the Ministry, with support from the European Union (TAIEX) and WHO Europe, for an external system review by an expert team convened by the European Centre for Communicable Disease Control (ECDC), working in close collaboration with national system leaders and experts. Agreed terms of the review included particular reference to the effectiveness and efficiency of the communicable disease surveillance and responses systems, their compatibility with EU requirements and norms, and advice on further strategic and technical development. The ECDC team, comprising experts from ECDC, the Republic of Romania, and WHO Europe (Zagreb collaborating centre), undertook preliminary enquiries and carried out a review in Moldova from 31 March – 4 April 2014, working closely with national leaders and experts, staff and related sector organisations, at both national and rayon/municipal levels. System achievements The international review team recognised a number of particular strengths of the system in Moldova, particularly since the substantive WHO review of 2001: Surveillance Surveillance is based primarily on a national passive system, with a clear and comprehensive legislative and regulatory framework, which appears generally well accepted by healthcare staff. System development proceeds in the context of well established strategic planning within overall public health system development. The surveillance system has a case classification system that is coherent with EU reporting requirements, and applied to reported cases by epidemiologists at local level. A pilot electronic surveillance system (SAE), is well established nationally, with good acceptance by data providers and public health staff. Regular descriptive reporting and analysis, mostly at national level, supports use of surveillance data for ongoing epidemic intelligence, monitoring of national programme targets, and to support national policy development and planning. Good use is made of web sites at both local and national level for dissemination of information. Outbreak recognition and management Outbreak reporting and management is subject to clear responsibilities and requirements, with local units supported as necessary by national teams. The SAE has a module for flagging in real time possible disease clusters based on doctor reporting of individual cases. Public health laboratories Primary diagnostic laboratories have benefitted from recent World Bank and European Union investment; facilities and equipment are generally modern and adequate, with a reasonable range of bacteriology and serology services and well established patterns of referral to national reference laboratories for selected pathogens. The reporting system provides a good overview of pathogens diagnosed by the national laboratory system. National reference laboratories carry out all the core functions expected in a European context. Some are internationally accredited, and participate in external quality assurance schemes; some are recognised as WHO national centres, and there is involvement in international surveillance and research projects. There is a good collaboration between microbiologists and epidemiology and clinical staff, at both local and national levels. 1 WHO (Regional Office for Europe). Assessment of the National Surveillance System for Infectious Diseases. WHO, 2002. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 2 of 95 Public health emergency preparedness Preparedness for response to public health emergencies is a shared responsibility at government level, between civil protection and public health. There is clear regulation for the authority and line of command in case of emergencies with potential public health impact. A national, multi-sectorial plan for disaster risk reduction is regularly updated. Districtlevel plans are in place to manage public health emergency situations, and reviewed regularly, with committees appointed to coordinate activities, and regular multi-sector simulation exercises. Rapid response teams at all levels of the health system are designated and trained. There is cross-Ministry planning and management for all crisis situations, including epidemics, and guidelines on preparedness planning for hospitals and district authorities. For management of major public health events, due to biological and radiological agents, specific intervention plans and operating procedures are developed and enforced. Health sector preparedness is monitored and evaluated. Workforce There is a dedicated epidemiological and microbiological professional workforce, familiar with the legislative and regulatory framework for their services. Protocols and standard operating procedures for epidemiologists are in place for several important service functions, with generally adequate working conditions and infrastructural support. There is also a well-established programme of guidelines for clinicians that include several communicable diseases of public health importance. Continuing professional education programmes for doctors are well established. System Challenges There are a number of areas where progress since 2001 has been rather muted; implementation of the WHO assessment findings appear to have been variable. Some system deficiencies could present challenges for effective and efficient collaboration with the communicable disease surveillance and control network of EU member states 2. The recommendations of the present review are summarised in Table 1 and set out in more detail in each chapter. A full listing is also given following the executive summary. Surveillance Although there has been considerable technical and legislative work since 2001 on developing priorities for communicable disease prevention and control, little of this appears reflected in daily work or annual reviews of the epidemiology services, at either rayon or national levels. Reported diseases are processed by rayon staff in a similar manner, with little analysis beyond reporting counts to NCPH on standard forms. Skills in the analysis of surveillance data at rayon level, and the IT infrastructure to support it, both appear very limited. This is only partly compensated for by a small epidemiological surveillance team at national level, which appears still heavily engaged by the demands of further development of the electronic surveillance system (SAE). With the exception of a few diseases (e.g. TB, HIV), there is little tailoring of either information required, or the investigation approach to the public health importance of the disease, or for understanding of the local epidemiology, or for the needs of national prevention and control programmes, or policy development. Analytical skills for the investigation of outbreaks remain limited at rayon level, and analytical methods are infrequently used, even when supported by national outbreak support teams. Continuing professional education of rayon epidemiologists and their support staff in these areas must be a priority. The SAE remains under pilot status, despite clear effectiveness and acceptability. The lack of legislative legitimisation of case information reported through it hinders its ability to support the implementation of a public health priority based approach to communicable disease surveillance, prevention and control. The SAE reproduces the traditional forms of reporting and can generate several different types of report; however it provides for limited data analytical capacities, especially at local level. Partly for this reason, data analysis even at national level remains limited, even in descriptive terms. The presence of a national system of surveillance case definitions, and its implementation by epidemiologists close to the case at rayon level, is a real strength of the system. However there appear to be no guidelines for, or training in, their use, and their precision in practice is uncertain. The sensitivity of surveillance appears quite variable, and there are some diseases of public health importance essentially unrecognised by the system. While some diseases appear to be subject to reasonable ascertainment (e.g. TB, salmonellosis, syphilis), others are almost certainly grossly under-reported, or not detected at all (e.g. campylobacteriosis, legionellosis, listeriosis, Chlamydia, West Nile fever, invasive bacterial diseases). Limited diagnostic laboratory capacities are an important factor here, although there may also be other underlying healthcare system 2 Decision 2013/1082/EC TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 3 of 95 issues that require investigation. It is difficult to develop, and have a balanced approach to development of policy, planning, surveillance and prevention for communicable diseases that are not reasonably recognised and reported. Some important diseases remain under surveillance through parallel systems (HIV, TB, STIs). There may be benefits in integrating at least some of these into the main surveillance system, particularly when the SAE is fully operational. Integration of STI and TB surveillance should have clear benefits. However, the effectiveness and efficiency benefits, and necessary precautions of such integration, for disease ascertainment and practical prevention and control purposes, need to be carefully assessed. Improved data protection arrangements may be required. There are clear improvements needed in HIV surveillance, regardless of the arrangements for its administration. Liaison with veterinary and food safety authorities’ remains very limited, and needs to be improved, including both more frequent liaison, and information sharing, of at least defined aggregate data. Public health laboratory system The primary diagnostic laboratories have been recently upgraded, and basic primary services and referrals appear to work well. However there are significant challenges for the ongoing provision and development of national reference laboratory services, including appropriate modern equipment and diagnostic technologies, consistent procurement (e.g. of test reagents), and housed in adequate buildings. Recruitment and retention of microbiology specialists is an increasing problem. There is no national system of biosafety and biosecurity regulation. There is insufficient liaison with laboratories in other sectors (veterinary, food, and environment). The role of laboratories in supporting communicable disease outbreak identification and management is unspecified. Health emergency planning While civil protection preparedness and response systems are well developed, and regularly exercised, the provision for public health emergencies, particularly related to major communicable disease outbreaks, or highly contagious cases, is less clear and secure. Strategic planning for public health emergencies requires development, with particular reference to compatibility with EU Decision 2013/1082, and testing through simulation exercises, and training of staff. The lines of command in a public health (c.f. civil protection) emergency require clarification. Communicable disease system workforce As above, formal assessment of the support for communicable disease surveillance, prevention and control through the training, recruitment and professional education of the workforce is beyond the present review. Incidental assessments and recommendations are made in the respective chapters. It is apparent that ongoing maintenance of a skilled workforce related to communicable disease surveillance, prevention and control is a strategic priority for the Moldova. There are major challenges: recruitment of graduates into the specialties is falling; retention of skilled staff difficult given better remuneration in other countries; the present workforce ageing; unfilled vacancies in the rayons. As above, there are important professional skills gaps to be addressed. While there are good educational facilities for specialist training and continuing education, more needs to be done to raise the profile of epidemiology and microbiology as careers, for nonmedical as well as medical graduates. The present medical specialist based model of public health may be unsustainable in the medium to long term; Moldova could usefully consider leadership in developing a multidisciplinary approach to public health, including communicable prevention and control, as practised in a number of EU countries. Page 4 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Table 1 - List of recommendations [Note: This table includes abbreviated descriptions only: reference should be made to main text for full statement and rationale] No Recommendation (heading) Priority*: public health impact Priority**: Page Ease of implementation Surveillance and outbreak response S1.1 Surveillance objectives and priorities 1 2 S1.2 Parallel surveillance systems 2 3 S1.3 Liason with veterinary and food safety systems 2 1 S1.4 Personal data protection 3 1 S2.1 Dual paper and electronic reporting systems 1 2 S2.2 Validation of case reports 2 1 S2.3 GIS support to rayon epidemiologists 2 2 S2.4 Early warning and alert system 1 2 S3.1 Use of surveillance data for national level public health functions 1 2 S3.2 Use of surveillance data at rayon level 1 2 S3.3 Gaps in surveillance 1 2 S4.1 HIV surveillance and information issues 2 1, 2 S4.2 STI surveillance 2 1, 2 S4.3 TB surveillance 2 2 S5.1 The epidemiology workforce 1 2 S5.2 Outbreak management lacks analytical investigation 1 2 S5.3 Analytical epidemiology skills of rayon epidemiologists and support staff 1 2 S5.4 Continuing professional education 1 2 S6.1 Guidelines and training for clinicians 1 2 Public health microbiology L1.1 Maintenance of diagnostic systems based on classical technologies 1 2 L2.1 National reference laboratory (NRL) mandate and nomination 2 1 L2.2 Sustainability of good quality NRL services 1 3 L2.3 Biosafety at NRLs 2 2 L2.4 Maintenance of laboratory capabilities with limited resources 1 3 L3.1 Sustainability and development of microbiology expertise 1 2 L3.2 Antimicrobial susceptibility testing 1 1 L4.1 Inter-sectoral collaboration 1 2 L4.2 Business continuity 2 2 55 Page 5 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 L4.3 Laboratory roles in national communicable disease emergencies 1 1 Public health emergency preparedness P1.1 Complex legislative framework 1 2 P1.2 Alignment to EU acquis 1 2 P2.1 Dispersed and overlapping responsibilities 1 1 P2.2 Biosafety and biosecurity 1 1 P3.1 Public health emergency planning 1 2 P3.2 Operational response planning for health emergencies 1 2 P3.3 Pandemic influenza planning 1 2 P4.1 Operational responsibility in public health emergencies 1 2 P4.2 Public health emergency training 1 2 P4.3 Rapid response teams 1 3 P5.1 Preparedness of local public health sector organisations 1 2 P5.2 Rayon level public health preparedness plans 1 2 P5.3 Links with EU institutions relating to public health emergencies 1 1 *1 = higher public health impact; 3 = lower ** 1= more amenable to implementation, 3 = less TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 1 Page 6 of 95 Introduction 1.1 Background In February 2014 the Ministry of Health of the Republic of Moldova submitted to the European Commission a request for the organisation of an expert country assessment mission through the TAIEX instrument. The general objective of this expert mission organized from 31 March to 4 April 2014 was to provide a peer-based assessment of Moldova’s national communicable diseases surveillance and public health emergency response systems. This mission occurred in a context of expressed interested by both the EU and Moldova to further develop their cooperation in the field of public health, with notably a view to raising the level of public health safety and protection of human health and strengthen the public health system of the Moldova. The European Union is developing an increasingly close relationship with Moldova, as a partner country within the European Neighbourhood Policy. In 2014 Moldova and the EU signed an Association Agreement3. This agreement includes identification of public health as a sector for increased cooperation, including in the area of epidemiological surveillance and control of communicable diseases. The specific objectives for this expert mission were to: Assess Moldova’s communicable diseases national surveillance system components (structure, process, capacities, effectiveness and coordination) and evaluate its coherence with EU legislation and normative practice in EU countries; Assess Moldova’s capacities to respond to public health emergencies; Provide advice for the development of an action plan setting up priorities for the strengthening of Moldova’s capacities in disease surveillance. Such an action plan would be particularly aimed at: Assessing the existing legal framework in the field of communicable diseases surveillance system with a view to support harmonization with the EU legislative acquis; Assessing public health capacities at national and local level; Revising and updating the list of priority communicable diseases; Adjusting the list of notifiable diseases and related case definitions. The conclusions of this expert review are intended to support the development and implementation of a 2-year national action plan aiming at strengthening Moldova’s surveillance capacities on communicable diseases, including coherence with EU acquis and professional and service practices compatible with those of EU member states. 1.2 Assessment Methodology 1.2.1 Pre-visit Objectives of the review, and terms of reference (ToR) were agreed with the Ministry prior to the visit (Annex 2). Within these parameters for assessment were drawn and adapted from standard ECDC assessment instruments for the communicable disease surveillance and response systems of enlargement countries. A self-administered questionnaire (SAQ) comprising key preliminary information requested in advance of the visit was forwarded to the Ministry and returned to the international review team prior to the visit. The international review team comprised two epidemiologists specialist in surveillance and outbreak response systems (one form ECDC, one from Republic of Romania), and a third, specialist in health emergency preparedness (ECDC). The fourth team member was a specialist in HIV and STD programme assessment and provided courtesy of WHO Europe (Zagreb collaborating centre). The final team member was a specialist microbiologist (ECDC). Team members from Romania and WHO Europe were funded by TAIEX and WHO respectively. The international team reviewed the SAQ response from the Ministry, including associated legislation and reports provided. Published reports by country authorities were also reviewed, as well as previous reports by international health authorities. The scope of the assessment included general review of the legislative and strategic framework pertaining to public health in general, and communicable disease surveillance and control in particular, and the structure, function, effectiveness, efficiency, quality and sustainability of the communicable disease surveillance and response, and health emergency preparedness functions, together with the microbiology services as supporting infrastructure. Human resource availability, training and continuing education were briefly considered in this context, but not formally assessed. 3 http://eeas.europa.eu/moldova/pdf/eu-md_aa-dcfta_en.pdf TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 7 of 95 The preliminary and in-country reviews were designed to give a coherent overview of the function of the surveillance and response system, both regarding performance of individual elements within it, their coordination, and apparent system effectiveness and efficiency overall. International team reviewers sought to follow the path of patients and information through the system, from symptomatic presentation to information in the surveillance system, and the uses of the latter for public health purposes, including policy, disease programme and service planning, routine disease control service work, and responses to outbreaks and health emergencies. 1.2.2 In-country For this purpose an itinerary was agreed, as part of the ToR, including site visits in two rayons significantly distant from the capital, and in Chisinau municipality itself. The team visited institutions and discussed with lead staff, as semistructured interviews, their functions in the surveillance and response system, relationships with other parts of the system, and other collaborating sectors, reviewed operational data, and facilities and infrastructure. Selected aspects of function at each institution were examined in detail. The international team was accompanied on site visits by members of the national review team. The itinerary commenced with a workshop including presentations by national leaders of key aspects of system legislative, strategic and functional organisation. Preliminary plenary discussions of findings of the international team were held during the visit, which concluded with a preliminary debriefing on the final day. 1.2.3 Post visit Following the in-country review, the findings of the international team relating to system components were reviewed, identifying key components of system operation, strengths and areas needing development. Interactions between systems were identified (particularly between surveillance, response, and laboratory systems), and recommendations identified grouped by their expected public health impact and ease of implementation. These findings were returned to national team members as a draft report for critical review, and comment, including correction of factual errors and additional information and observation. The final draft report responding to this input was returned for final review to Moldova team members in December 2014 and the final report submitted to the Ministry of Health in March 2015. A listing of the international and national review teams, and principal country respondents, and detailed itinerary are given in Annexes 1 and 2. 1.2.4 Assessment limitations The present assessment was completed by a small international team over five days in-country, supplemented by documentary review before and after the visit. Only a limited number of organisational entities, leaders and locations could be visited in that time. In particular it was not possible to formally interview leaders involved in workforce education, specialist and occupational training, continuing education and workforce planning. 1.3 Country profile 1.3.1 Geographical, Political, Economic background The Republic of Moldova became independent in 1991 after the break-up of the former USSR. Moldova is divided into thirty-two districts (rayons) and three municipalities, with 3.5 million habitants4. The autonomous unit of Transnistria, on the eastern border, is not under direct government control, and was not included in this review. 4 Country Cooperation Strategy at a glance, Moldova, WHO/Europe, 2013 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 8 of 95 Figure 1 - Republic of Moldova: administrative divisions With an economy dominated by agriculture and food processing, 58% of its population live in rural areas and 42% in urban areas5. 5 Sources: Monitoring official development assistance to the health sector in the Republic of Moldova, WHO/Europe 2012 report. Page 9 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 The economic transition that followed the accession to independence caused considerable socioeconomic hardship in the country and the health status of the population fell, with a steep rise mortality, and negative population growth for several years4. Moldova embarked on an ambitious programme of economic reform. Although Moldova is still one of the poorest countries in the WHO European Region, its recent economic performance has been strong, if volatile: GDP growth has been solid in recent years5. While the Human Development Index (HDI) is below the European region average, it has been on an upward trend. The health status of the Moldovan population has been steadily improving; Moldova regained its pre-independence life expectancy at birth (69 years) in 2010. The infant mortality rate has been falling steadily since the mid-90’s, reaching 11 per 1000 live births in 20114. Nevertheless, challenges persist. While increasing, life expectancy remains low compared with other countries of the WHO European Region. Mortality and morbidity rates are high among the working-age population5, particularly associated with non-communicable diseases (coronary heart disease, cancer), and lifestyle risk factors, including heavy alcohol and tobacco consumption4. Table 2 - Economic indicators, Republic of Moldova, 2011 5 Indicator Level GDP growth 6.41% Population 3 559 000 GDP per capita $3369 World Bank country classification Lower middle income HDI 0.649 1.3.2 Health Reforms At independence in 1991, Moldova had a health system with numerous facilities and staff but limited resources to sustain them. Despite some reductions in capacity, Moldova in 1997 had one of the most extensive networks of health facilities and health staff in either Western Europe or other countries of the former Soviet Union (World Bank 2000) 6. Economic constraints post-independence led to the dramatic consolidation of the healthcare system, with reductions in the number of hospital beds, activity levels and personnel. Moldova inherited the Semashko health care system model from the former Soviet Union. Mandatory health insurance was introduced in 2004, which has driven the health system towards universal coverage, and greater emphasis on primary care, which has been reformed on a family doctor model4. Primary and secondary health care have been reformed and consolidated. Primary care is based on family doctor services, on a general practice model. Additional challenges include health workforce shortages: emigration, the broadening of alternative career opportunities and low wages mean that the country is facing recruitment problems for key health workers, particularly in rural areas and in the primary health care system. The national sanitary-epidemiology services were reformed as the National Centre of Preventive Medicine, with further reform as the Public Health Service in 2009. Key policy documents have been developed for the sector: the National Health Policy 2017-2021 and the Healthcare System Development Strategy 2008-2017 both identify mid- and long-term reform priorities4. 6 Health systems in transition. Moldova health systems review (2008) Page 10 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Table 3 - Health Indicators, Republic of Moldova Indicator Life expectancy at birth (2010) Level 4 69.13 Under-5 mortality rate per 10004 19 Maternal mortality rate per 100 000 live births(2010) Total expenditure on health as % of GDP(2010) 4 44.47 4 11.7 Prevalence of TB burden (2012)7 Estimated MDR-TB among new cases (2012) 249 (per 100 000) 7 Estimates MDR-TB among previously treated cases(2012) HIV prevalence among TB cases(2012)7 HIV incidence per 100 000 population (2011) 24% 7 62% 6% 5 20.25 1.3.3 Infectious disease challenges Tuberculosis, HIV and syphilis remain major public health priorities in Moldova. Reported rates of salmonellosis and EHEC are high compared with those reported in EU countries. At the same time significant emerging diseases in South East Europe may provide challenges for detection and response (e.g. West Nile virus infection). Some communicable diseases of public health importance may be under-recognised (see section 2.9). 1.3.4 Development partners Moldova is benefitting from international support to reform and strengthen the health care system. A number of international agencies8, in addition to WHO, are active in supporting Moldova through technical assistance, capacity building, and funds. In 2010, 9.6% of total health expenditure came from external sources4 in the form of project-based donations and loans from international actors including the EU, the World Bank, GFATM, GAVI and various United Nations agencies. In 2011, this official development assistance for health reached $59.1 million, across both communicable and non-communicable diseases. In 2014 Moldova and the European Union signed an Association Agreement. This Agreement includes identification of public health as a sector for increased cooperation, including the area of epidemiological surveillance and control of communicable diseases. 1.4 Health systems profile 1.4.1 Principal health authorities and organisations (a) Overview The healthcare and public health systems of the Republic of Moldova are complex involving a number of state authorities. Rayons and municipalities are responsible for healthcare services at all levels (emergency, primary, secondary and tertiary); these are funded primarily through mandatory health insurance, introduced in 2004. The state Public Health service (PHS) – which includes the national and rayon and municipal centres of public health – addresses population health issues, and is accountable to and directly financed by the Ministry of Health. 7 8 2012 TB Country work summary, WHO/Europe UNDP, UNICEF, UNFPA, UNODC, UNAIDS, IAEA the World Bank, European Union, and international NGOs TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 11 of 95 Figure 2 - Organisation of the health system, Republic of Moldova Source: the National Centre Public Health (b) Health system financing Mandatory health insurance funds most of healthcare in the Republic of Moldova, funded through contracts with the National Health Insurance Company (NIHC). NHIC is funded by employer payroll contributions, transfers from the national budget to cover the non-working population, direct payments from self-employed workers, state budget allocations and a small amount from income derived from services. The Ministry of Health plans and administers the state budget in the health sector. Once the budget is approved by Parliament, the Ministry of Health can reallocate the resources based on current priorities or emerging needs. 1.4.2 Principal organisations in communicable disease prevention and control (a) Ministry of health The Ministry of Health is responsible for developing and monitoring the implementation of public health policies, legislation and regulation in the health field, promoting the inclusion of health related action in all public policies, and supporting their efficient implementation in other sectors. The Directorates of Public Health, Hospital Care and Emergencies, and Primary Healthcare at the Ministry are headed by respective Deputy Ministers. The Deputy Minister of Health is also the main state sanitary doctor9. 9 Law No. 10-XVI (3 February 2009) on state surveillance of public health TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 12 of 95 Figure 3 - Organisational chart of the Ministry of Health, Republic of Moldova Source: the National Centre Public Health (b) Public Health Service (PHS) The State Public Health Service (PHS), which is seen as an integrated set of entities from the Ministry of Health, including the Chief State Sanitary Doctor of the Republic, to the National Centre for Public Health and Centres for Public health at municipal and rayon level. The PHS is headed directly by a Deputy Minister, and coordinated by the Ministry through the Directorate of Public Health. (c) National Centre for Public Health (NCPH) The NCPH is directly accountable to the Ministry of Health, and is responsible for most core public health functions at the national level. The Centre was restructured in 2010. The Centre monitors and assesses the public health and the healthcare systems, and gives expert health policy advice. It provides data and reports on principal health indicators; prepares programmes and measures for the prevention of disease; works on the professional development of public health experts, and performs public health research. The NCPH also recognizes threats to health and draws up measures for their mitigation; provides technical and methodological support to rayon and municipal Centres of Public Health; assesses and reports on implementation of national public health policies, and serves as a training centre. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 13 of 95 Figure 4 - Organisational chart National Centre Public Health Source: the National Centre Public Health (d) Rayon/municipal Centres of Public Health The rayon/municipal centres of public health (CPH) were also restructured in 2010. They are accountable directly to the Ministry of Health, and rely on NCPH for technical support. Rayon and municipal Centres of Public Health coordinate the implementation of national public health policies in their jurisdictions. They undertake core public health functions, including monitoring, prevention, health protection and promotion, and report periodically to the NCPH regarding the main health indicators and the implementation of national programmes and ministerial orders. Rayon CPH structures and organisation vary with size of the population served, but all have divisions or departments for communicable disease surveillance and control, health promotion and non-communicable disease surveillance, health protection (including environmental health, occupational health, child and adolescent health) and public health management. These services are underpinned by microbiology and environmental laboratories, IT and administrative and logistics support. (e) Public health microbiology services The Public health microbiology system in Moldova is based on microbiology and sanitary-hygiene/environmental laboratories in each of the 36 rayon or municipal centres for public health (CPH), together with the equivalent laboratories at NCPH. In addition there are two radiological laboratories, located in Chisinau and at the NCPH Balti. The core functions of the CPH laboratories are to provide investigations for the detection and confirmation of cases of infectious disease, and of wider public health threats (biological, chemical, radiological). Clinical and environmental (food, water, vector) samples are tested in public health microbiological laboratories, at both national and rayon level. The national level laboratory performs both primary diagnostic and reference laboratory functions. (f) Primary care, hospital services At rayon/municipal levels there are 49 centres of family doctors (35 in districts, one in Balti and 13 in Chişinău municipality). Depending on the population served, there are family health centres with, typically, 3-4 doctors, single doctor practices, and health offices without physicians. In Moldova there are 82 hospitals, almost half of which are in Chişinău municipality, and accounting for over half of all beds. National hospitals have 36% of all beds, and municipal and rayon hospitals account for 54% of beds. The private TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 14 of 95 hospital sector is very small (1% of beds). There are continued reforms of the secondary services sector, to reduce duplication, overlapping of services and oversupply of beds, particularly in Chisinau. (g) National Centre of Health Management (NCHM) The NCHM is an entity accountable to the Ministry of Health, responsible for supporting establishment of the roles, objectives and procedures of health service providers. In particular, it is responsible for analysis surveys/studies of disease risk factors; maintaining and managing the national health statistical database; coordinating the collection, processing and analysis of statistical information on population health and of the medico-sanitary institutions’ activity results; and developing and implementing assessment systems for national health programmes (for example, HIV/ AIDS and TB programmes). (h) National health insurance Company (NHIC) The NHIC is an autonomous entity responsible for managing compulsory HIFs. The main tasks of the NHIC include: establishing and managing the mandatory health insurance system (including applying the appropriate procedures and mechanisms for creating financial funds to cover the health care costs, in accordance with the unique mandatory health insurance programme), quality control of the health care provided, and implementing the regulatory framework for mandatory health insurance. 1.4.3 Other sectors involved in communicable disease control (a) Ministry of Agriculture Ministry of Agriculture’s responsibilities includes responsibility for animal health, zoonotic and vector-borne diseases. At rayon and municipal level, investigation of zoonotic and foodborne diseases is conducted by epidemiologists in conjunction with specialists from veterinary services. (b) Food Safety Agency (FSA) The FSA has been recently established as an entity separate from the Ministry of Agriculture, reporting directly to Government. It is responsible for ensuring safety throughout the food chain, ‘from farm to fork.’ The main responsibilities of the FSA include animal health, control of zoonoses, and cooperation with the MoH on food safety. (The MoH is responsible for the prevention of foodborne diseases, and for leading primary and secondary prevention interventions, and epidemiological investigation of foodborne outbreaks. (c) Ministry of Environment The Ministry of Environment is responsible for developing and promoting state policies in the area of environment protection and relating to the rational use of natural resources, waste management, biodiversity conservation, geological research, use and protection of underground sites, water and sanitation supply, and the regulation of nuclear and radiological activities. The Ministry participates in planning and implementing measures for avoiding occurrence of natural disasters (floods, droughts) and management of their consequences. Among other duties, the authority regulates human activities relating to the environment, where these may impact on public health. 1.4.4 Communicable disease system workforce (a) Epidemiologists and support staff Epidemiologists lead both communicable and non-communicable disease divisions or departments at national, municipal and rayon levels. There are currently 140 epidemiologists including: 32 at the National Center for Public Health, 84 in 34 rayon Centers and two municipal Centers for Public Health (Chisinau, Balti), 11 in 4 departmental Centers for Preventive Medicine (including ministries of Internal Affairs, and Defense), and 13 in hospitals. Overall it is estimated that there are 3.2 epidemiologists per 100,000 population. At rayon/municipality level the epidemiologist: population ratio is approximately 1:42,000. Epidemiologists are medical graduates with two years specialist training. At present five to ten doctors enter the specialist training programme each year. Epidemiologists are responsible for the surveillance and control of communicable diseases in the rayon or municipality, among other responsibilities (see chapter 2). They also administer and report on childhood immunisation programmes. Epidemiologists have support staff who assist with administration of infectious disease reports and their investigation and reporting. Epidemiologist assistants have two years of training after general lyceum study, following a special curriculum in public health at two municipal colleges (in Chisinau and Balti). TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 (b) Page 15 of 95 Public health microbiologists Microbiologists are medical graduates with five years specialist training. Only laboratories at NCPH and in larger rayons or municipalities are led by specialist microbiologists; most at rayon level are managed by microbiology technicians, supported by NCPH microbiologists. At present NCPH employs 12 microbiologists and 20 technical staff. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 2 Page 16 of 95 Surveillance 2.1 Surveillance objectives, legislative framework 2.1.1 Overview The objectives and development of the surveillance and control of communicable disease is set out in the principal Act (below) and further elaborated through Government decisions, Ministerial orders, and the National Strategy on Public Health for 2014-2020. Healthcare and public health staff are also supported through publications of guidelines and indications. 2.1.2 Legislation and regulation In the Republic of Moldova the surveillance of communicable, and non-communicable diseases is carried out and regulated in accordance with Law No. 10-XVI (3 February 2009) on state surveillance of public health. This “principal Act” sets out the general citizen rights and obligations of persons in Moldova, to public health in Moldova, the basic goal and principles of state policy in public health, and principal activities of the state in pursuing these. It sets out the content of public health surveillance, (as a broad activity also involving health promotion, disease prevention and control programmes), and the competencies and powers of government, Ministry of Health, other central and local government authorities. In particular, the Law established and sets out the responsibilities powers and organisation of the State Public Health Service (PHS), which is seen as an integrated set of entities from the Ministry of Health, including the Chief State Sanitary Doctor of the Republic, to the National Centre for Public Health and Centres for Public health at municipal and rayon level. It also authorises the establishment and principal functions of the state surveillance information system. Other important primary legislation relating to communicable disease control includes legislation on health services, and control of HIV/AIDS and tuberculosis (see Annex 3). In relation to communicable disease prevention and control, the principal Act is supplemented by Government Decisions, Minister of Health orders and decisions, and Guidelines (see Annex 3). The principal generic legislation includes: Gov. Decision related to State Surveillance of Public Health nr. 384 (12 May 2010);10 Gov. Decision on approving Regulation related national surveillance and control of communicable diseases and public health events nr. 951 (25.December 2013);11 Order No. 368 (13 December 2004): submission to the Ministry of Health of urgent and mandatory information on emergencies and natural disasters; Order of the Ministry of Health No. 171 (20 June 1990): on improving the record system of certain infectious and parasitic diseases in the Republic of Moldova; Order No. 385 (12 October 2007): approving case definitions for surveillance, and reporting of communicable diseases in the Republic of Moldova; Order of the Ministry of Health No. 13 (11 January 2011): approving the notification form (emergency notification data sheet) on reporting case identification of communicable diseases, poisoning, foodborne diseases, occupational acute poisoning, and/or side-effects after administration of immunobiologic products. This primary legislation is further enacted through Ministry of Health orders covering mandatory notification of defined diseases and public health events, including outbreaks (2004), the introduction of national case definitions (2007), development of the public health laboratory surveillance network (2013) and national surveillance and control of communicable diseases and public health events (2013)12. Data exchange between the veterinary service and public health surveillance is also underpinned by regulation (see Annex 3). 10 http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=334620 http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=350538 12 MoH order on approving of case definition for diagnosis, recording and reporting of communicable diseases in the Republic of Moldova nr. 385 from 12.10.2007 MoH order regarding the implementation of the Programme for development of state surveillance public health Laboratory Network in RM nr.668 from 10.06.2013 11 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 17 of 95 2.1.3 Guidelines and protocols Below the level of legislation and regulation there is a substantial programme of protocols and guidance developed directly by NPHC. Protocols and guidance for clinical case management are in place for several notifiable diseases (e.g. salmonellosis, cryptosporiosis, echinococcus, hepatitis B, rotavirus infection in children, nosocomial infections, investigation of HIV/AIDS, microbiological investigation of campylobacteriosis, among others). These are often extensive, although concentrating primarily on clinical management. Guidelines for epidemiologists have also been developed for specific diseases (e.g. influenza, HIV/AIDS, hepatitis, rotavirus infection, cholera, tularemia, Annex 3). 2.1.4 National Strategies The National Strategy on Public Health 2014-2013 sets out the context of public health issues in terms of population health status, principal causes of morbidity and mortality, and their risk factors. It also outlines the various organisations responsible for collaborating on implementing the strategy, across health promotion, health protection and primary and secondary disease prevention. It also sets out key issues relating to public health workforce, and research Communicable diseases are addressed in the Strategy along with non-communicable diseases and the same key strategies identified, including; an improved legal framework, sustainable financing, cross-sector collaboration, strengthening PHS capacities and knowledge and practices of health workers, and promotion of early detection through strengthened national surveillance systems. Vaccine preventable and nosocomial diseases are specifically identified. In relation to communicable diseases and public health events, the Action Plan for 2014 -15 includes objectives related to communicable disease surveillance, epidemic intelligence and early detection and response, preparedness for public health emergencies (see chapter 4) and strengthening laboratory capacities (see chapter 3). 2.2 Identification and reporting of diseases under surveillance 2.2.1 Diseases, syndromes and health events subject to mandatory reporting There are presently 72 infectious diseases and syndromes that are mandatory to be reported by healthcare staff in Moldova. In addition six health problems are reportable (e.g. nosocomial infection, antibiotic resistance) (see Annex 4). It is also required to report a number of other events, including outbreaks, natural disasters, chemical or radiological incidents. 2.2.2 Reporters All health care workers are required to report suspected or confirmed cases of disease or events specified in the notifiable disease list. Events potentially reportable under the International Health Regulations, 2005 (IHR) must be reported to the IHR focal point14. 2.2.3 Diagnostic confirmation Cases are referred for laboratory investigation according to clinical judgement, supported by protocols and guidance covering several of the commonly occurring and/or important communicable diseases and syndromes (as above)15. Cases notified initially on suspicion and expected are confirmed through laboratory investigation. 2.2.4 Reporting Cases of infectious diseases are reported by the primary, emergency, and specialised (infectious diseases doctors) healthcare, and hospitals (in case of nosocomial infections) to the regional epidemiologists at the territorial Public Health Centres (PHC). Doctors report according to one of the notifiable diseases or syndromes, and assign an International Classification of Disease (ICD-10) code to the case; this applies to both confirmed and unconfirmed (suspected) cases. Paper reports use form 058/e; a two sided A4 size form which also provides for extensive clinical information through tick boxes on the reverse side; much of this latter information is optional and often only partially completed (Annex 5). 13 Gov. Decision on approving Strategy on Public Health for period 2014-2020, 20.12.2013, Nr.1032, M.O. nr. 304-310, art nr.1139 din 27.12.2013 http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=350833 14 IHR National Focal Point in accordance with MoH order regarding implementation of Gov. Decision nr. 475 from 26.03.2008 on approving Action Plan for IHR implementation in the Republic of Moldova nr.268 from 06.08. 2009 15 In accordance with MoH order regarding the implementation of the Programme for development of state surveillance public health Laboratory Network in RM nr.668 from 10.06.2013 http://www.cnsp.md/down/info1371468083ro.pdf, is mentioned the level of different public health laboratories core capacities and commences for confirmation TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 18 of 95 2.2.5 Electronic reporting system This paper reporting has been supplemented, since 2010, by a dedicated electronic system for communicable disease reporting (System on Epidemiological Alerts). This system is a dedicated stand-alone reporting system (electronic patient records are not yet developed in Moldova). The system is however linked to demographic and health care worker registers. The electronic system appears generally user friendly and well accepted by the healthcare staff sending the reports – it is understood there was initial resistance from some doctors which has largely settled. Microbiology staff enters laboratory test data directly into the system. The system is now entering a second phase of development, supported by World Bank funds, increasing its technical capabilities and its extension to medical practices is continuing. However, it has not been mandated by regulation as a sole form of reporting, and even where it is available, doctors must also report using the traditional paper system. Where medical practices do not have access to the system, or even to the internet, PHC staff may offer services to support the reporting process. 2.3 Data processing, analysis by the Public Health Centres 2.3.1 Receipt of reports Reports on communicable cases are received by the rayon (territorial) epidemiologists at the Public Health Centres (PHC) by two modalities, as above: paper forms and the electronic reporting system (SAE). Some urgent reporting is also done by telephone. The electronic system is generally preferred by PHC staff. Epidemiologists and designated staff have access in real time to cases reported by doctors, and to confirmatory test data entered by laboratories. The national ID number is used as the common identifier linking the medical and laboratory reports. Paper reports are also received, checked against the electronic data if applicable, and filed. If there is only a paper report, PHC staff enters the data into the SAE. 2.3.2 Case classification Regional Epidemiologists at the rayon centres for Public Health (CPH) review the reported cases on a daily basis, and make operational decisions re follow-up and further investigation that may be necessary. On a daily basis the epidemiologists classify the cases (reported by doctors as ICD-10 codes) according to the national system of surveillance case classification16, as possible, probable and confirmed. Although official reports tabulate data according to reportable entity and ICD-10 code, only cases that are confirmed through this process by local epidemiologists are included in the tables. The national surveillance case classification system was first developed in 2006, following the WHO system review recommendations in 2001, and revised in 2007, to align more closely with case definitions for reporting to EU level. There are no written procedures or protocols for PHC epidemiologists covering this process of classification of cases for surveillance purposes (beyond the end result expressed in the case classification per se), and approaches taken by local epidemiologists to this process appear to vary. This variation appears more marked for some syndromes, e.g. ILI, SARI. 2.3.3 Data analysis (a) Rayon level At rayon level epidemiologists and staff produce weekly and monthly standard summary reports (Form 2) of the number of confirmed cases received, together with incidence rates by disease, age group and locality (based on population data provided by central statistical authorities17). Standard weekly reports including trend analyses are produced for major groups of diseases and syndromes (e.g. acute diarrhoeal diseases), and (e.g. diarrhoea disease, acute respiratory disease) and seasonal reports are produced for influenza monitoring (ILI, ARI, SARI syndromes). Routine reports of immunisation coverage are also produced. Beyond these standard reports there is little additional or ad hoc analysis by rayon epidemiologists. Data export for analysis is not well supported by the SAE, and analytical skills of rayon epidemiologists and support staff are not apparently well developed. Data reported for most cases is limited or variably complete and additional data collection is not usually undertaken. 16 MoH order on approving of case definition for diagnosis, recording and reporting of communicable diseases in the Republic of Moldova, 12.10.2007, nr. 385 17 Statistical evidence Form no. 2 “Statistical report on communicable and parasitic diseases”. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 19 of 95 Outbreak reporting and investigation are outlined below (see 2.5). (b) National level Epidemiologists and designated analytical staff at the National PHC have access to anonymised individual case reports in the SAE. Both routine and specific analyses are carried out based primarily on cases validated as confirmed by rayon epidemiologists – routine statistical reports are based on cases confirmed according to the national case classification scheme.. The SAE generates standard reports for weekly and monthly reporting of numbers and incidence of confirmed cases of diseases and syndromes subject to mandatory reporting. These regular analyses are produced by disease, age group and rayon and locality. Standard denominators are used, derived from census data and projections. Analyses of incidence trend are carried out for each of the major reportable diseases, on at least a yearly basis, and published in the Annual Report18. These are usually descriptive trend analyses over recent years, with some breakdown of demographic data as appears pertinent to the situation; accompanied by a short descriptive text. Routine descriptive analyses of risk factors are also periodically undertaken, where data is available for particular diseases (e.g. TB, HIV, Hepatitis B and C, etc). Immunisation uptake standard analyses are completed regularly. Beyond these routine and annual standard analyses, there is limited analytical analysis or applied research undertaken, either by NPHC or in association with academic institutions. The NPHC neither publishes frequently in refereed journals, nor commissions projects from or with academic partners. The epidemiological analytical team at NPHC is small, and guiding the further development of the electronic reporting system is a substantial burden. 2.4 Reporting and feedback 2.4.1 Rayon level At local level the routine surveillance reports on notifiable diseases, diarrhoeal and influenza syndromes are made available to primary healthcare and hospitals, and other local stakeholders, on a weekly and monthly basis. These are primarily statistical tables with little or no interpretive text comment. Brief information related to local outbreak(s) are included if relevant. An annual report is also produced, which is sent to local hospitals and health centres, and some rayons publish on their websites22. 2.4.2 National level The NPHC circulates the weekly and monthly reports on reportable disease frequency and incidence, syndromic diarrhoeal and sentinel influenza and rotavirus surveillance, as described above, to the Ministry, specialist staff from PHCs and healthcare workers19. NHPC also provides reports on epidemic intelligence and national outbreaks to the Ministry on a weekly basis, and more frequently if required (see below). An Annual Report is produced, as described above, and published both in hardcopy and on the Ministry website. It is distributed to data providers and stakeholders as described above. Other means of communicating with stakeholders include scientific meetings 20, inter-sectoral governmental meetings, national conferences, and professional fora21. 2.5 Outbreak recognition, management, investigation and reporting 2.5.1 Overview Outbreaks are defined in MoH documentation as a situation when diseases or health events occur at a greater frequency than normally expected in a period of time and place. In practice, at both rayon and local level, two or more linked cases constitute a potential outbreak, for management and reporting purposes. 18 SUPRAVEGHEREA DE STAT A SĂNĂTĂŢII PUBLICE ÎN REPUBLICA MOLDOVA (RAPORT NAȚIONAL), Minitsry of Health, 2014. http://cnsp.md/submeniu.php?id1=37&id2=0 20 http://cnsp.md/submeniu.php?id1=50&id2=0 21 http://ms.gov.md/?q=colegiul-ministerului http://www.gov.md/libview.php?l=ro&id=6459&idc=436 19 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 20 of 95 Thirty-three outbreaks were reported in 2013, 32 with diarrhoeal disease (503 cases) and one measles outbreak (27 cases). 2.5.2 Outbreak detection (a) Local level At local level primary care and hospital doctors are expected to notify the rayon epidemiologist(s) if they suspect an outbreak – that they are seeing more cases than expected. Microbiologists also report suspected outbreaks through changes in pattern of laboratory requests received and identifications made. Finally, managers of institutions such as (schools, preschools, workplaces, long term care centres) are also expected to report if they suspect an outbreak (through absenteeism, etc). Rayon epidemiologists report suspected outbreaks on a prescribed form, or through the outbreak/event reporting facility on the SAE. In some urgent situations NPHC may be informed directly by healthcare staff regarding an outbreak or case with a high public health risk. (b) National level At national level, NPHC epidemiologists may also become aware of outbreaks through two additional sources: (i) Epidemic intelligence This is in an early stage of development at NPHC; staff review national and internal media reports, and global epidemic intelligence websites, on a daily basis. Events within country are followed up for assessment and verification by rayon epidemiologists on request from NPHC; (ii) Early warning system component of SAE In addition to a general outbreak/event reporting facility, the SAE has a component where the indicator (individual case based) surveillance reports are reviewed automatically on a daily basis for the presence of potential clusters of cases. These clusters are identified according to criteria set by the epidemiological system managers (e.g. x cases of disease X within a given locality within x days). Aberration detection software is not deployed (e.g. EARS). Flags are reviewed daily by NPHC epidemiologists and referred as necessary to rayon epidemiologists for follow-up and verification. 2.5.3 Outbreak management, including investigation (a) Rayon level Routine local outbreaks are managed or supervised by rayon epidemiologists, in conjunction with sanitary, veterinary and/or food safety inspectors as required by the situation, and with active involvement of health care staff as needed. Most outbreaks are of diarrhoeal disease, and investigation usually includes substantial microbiological investigation of affected persons, food and environment. Associated epidemiological investigation is usually limited to interviews of cases, identification of linked cases, and simple descriptive analysis. The cause of the outbreak is assigned by the epidemiologist, on the basis of microbiological findings (if positive) or of ‘experience.’ Some outbreaks are classified as of source unknown. Analytical epidemiological investigation methods (e.g. case control or cohort studies) are rarely employed; epidemic curves are not routine. (b) Larger outbreaks and events/outbreaks of high public health risk In these cases, rayon epidemiologists are supported by teams from NPHC, who go out to the rayon to assist with the investigation and management of the situation. Such teams are multidisciplinary, usually of 4-6 persons, and are deployed on request of the rayon or NPHC initiative. In 2013 such teams were deployed from Chisinau on twelve occasions. 2.5.4 Reporting of outbreaks Rayon epidemiologists file ‘closure’ reports on outbreaks once management and investigation is complete, either on SRE or prescribed paper forms. Reports on the outbreak occurrence and progress may be included as appropriate in local and national weekly reports. NPHC prepares a summary of outbreaks formally reported during the year but this is not formally published as defined section of the Annual Report; indications of outbreak activity are given in relevant parts of the Report. 2.5.6 Incident reviews Outbreak report ‘closure forms’ are routinely forwarded to and reviewed at national level. Incident reviews, including outbreak management, are not routinely conducted at either rayon or national level. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 21 of 95 2.6 Data protection, data access 2.6.1 Overview The protection of personal health data, including information concerning notifiable infectious diseases, is provided for in national law and regulation. All staff employed in healthcare and rayon and national level PHCs are made aware of their responsibilities as part of employment. 2.6.2 Access to personally identifiable information The personal identity of reported notifiable disease cases is (with some exceptions) generally confined to staff at rayon level. Staff at rayon PHCs is required to protect the identity of cases reported. However few specific organisational procedures to restrict the number of staff who could see or access reports appear to be in place, particularly for diseases with potentially stigmatic associations (e.g. STIs, hepatitis, TB). National level staff generally has access only to anonymised cases (identified by national number, and by epidemiological (event/episode) number generated by the system). Within the SAE, considerable attention has been given to the protection of personal data, and the designated staff entitled to use the system has access only to relevant cases within their jurisdiction or area of reporting responsibility. This system of levels of access is administered and monitored by SAE epidemiologist administrators at NPHC. 2.6.3 Risk of deductive disclosure Deductive disclosure remains a significant risk, particularly (but not exclusively) at rayon level. While transparency of reporting is valued, reporting of individual cases within a locality and restricted time period can make the affected individuals vulnerable to deductive disclosure. 2.6.4 Special situations There are some exceptions to this general data protection infrastructure. TB cases are still required to be reported by name to the Minister of Health. HIV and AIDS cases are reported to a national registry at the Hospital of Dermatology and Communicable Diseases. 2.7 Parallel Disease specific surveillance systems 2.7.1 Overview Surveillance of a number of diseases of public health importance is administered in parallel to the main surveillance system, particularly with respect to initial case reporting and data administration and analysis. These include, in particular, tuberculosis, HIV and AIDS, and sexually transmitted infections (STI). 2.7.2 Sexually Transmitted Infections Programme governance, plan/strategy, priorities, and objectives The national STI programme and STI surveillance is part of the National Program for HIV/AIDS and STIs Prevention and Control that is co-ordinated as of 2012 by the Hospital of Dermatology and Communicable Diseases. STI screening, diagnostic testing, treatment and prevention services are provided at various clinical sites, but primarily by dermatovenereology (DV) services. The surveillance system consists of the disaggregated reporting of cases of syphilis gonorrhoea and chlamydia by DV services, the monitoring of syphilis prevalence in pregnant women, and STI prevalence assessment through integrated bio-behavioural surveillance surveys (IBBS) in key populations22. STI case reporting The main source of STI case report data is outpatient DV services, which operate in each rayon/municipality as part of the district hospital, and in Chisinau as a part of the Municipal DV Centre. Patents both self-refer and are referred from general practitioners. DV services report cases of syphilis, gonorrhoea and chlamydia using individual-level electronic and paper-based forms, on a monthly basis to both the National Centre of Public Health (NCPH) and the Hospital of Dermatology and Communicable Diseases. STI cases are also reported from six departments that operate outside of the health care sector (e.g. the Ministry of Interior, Justice, Defence, Civil Aviation) and report on an annual basis to NCPH. DV services also carry out regulatory 22 Female sex workers [FSW], people who inject drugs [PWID], men who have sex with men [MSM]), prisoners. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 22 of 95 screening programmes of employees involved in various defined occupations involving contact with children (including doctors). A significant minority of STIs are diagnosed in this way. Cases of syphilis are largely treated by dermato-venereologists, although an unknown proportion of patients are thought to consult private physicians. Patients diagnosed with gonococcal infection can also be treated outside of the DV services, predominantly by gynaecologists and urologists; case notification forms for patients with gonococcal infection are required to be sent to DV specialists who report them to the National Centre for STIs and NCPH. Reporting is mainly name-based, though it can also be done anonymously using a system of unified codes. It was stated during a visit to the Municipal Centre for Dermato-Venereology in Chisinau that approximately 80% of their STI case report forms are assigned such codes instead of names. 2.7.3 HIV and AIDS (a) Overview HIV surveillance is part of the National Program for HIV/AIDS and STIs Prevention and Control (NAP) that since 2012 is co-ordinated by the Hospital of Dermatology and Communicable Diseases. Previously, HIV surveillance system was coordinated by NCPH. The National AIDS Programme is implemented through the National Programme on Prevention and Control of HIV/AIDS and STI for 2011–201523. Implementation of the NAP is coordinated by the National Coordination Council for HIV and TB, an inter-ministerial and inter-sectoral decision-making body. (b) Reporting and surveillance HIV surveillance in Moldova consists of HIV case reporting, reporting of AIDS deaths, integrated HIV bio-behavioural surveys (IBBS), population size estimates and HIV testing data. Reporting of HIV cases is through a system parallel to the main surveillance system. Infectious disease clinicians (since 2012) send completed HIV case report forms from the local level direct to the National AIDS Programme based at the Hospital for Dermatology and Communicable Diseases (HDCD). During 2013, data on the mode of HIV transmission were reported for approximately 44% of 706 reported HIV cases. In the previous years, completeness of mode of transmission data was reportedly much higher. Approximately 70% of newly diagnosed HIV patients have CD4 count testing; however no data on CD4 counts in newly diagnosed HIV cases were found in the reports that describe the HIV epidemic in Moldova. 2.7.4 Tuberculosis TB is a public health priority in Moldova, with a reported incidence of pulmonary TB of 86/100,000 in 2013. The trends in TB notification rates in the Republic of Moldova have not significantly decreased in the last five years; late diagnosed cases are frequent. The Republic of Moldova has one of the highest documented levels of multi-drug resistant TB (MDRTB) in the world; around one third of newly diagnosed TB patients two thirds of those returning for treatment have MDR-TB. Co-infection with HIV is frequent, and cases of nosocomial infection occur, including among hospital staff. Moldova has a strategic plan for Tuberculosis and is supported by a number of global partners, particularly the Global Fund. It is supervised by the national Coordination Board for TB and HIV programmes, and the Ministry. The programme was reviewed by WHO Europe in 2013. TB surveillance is administered separately from the main communicable disease surveillance system as a parallel system. Surveillance is based on a combination of passive case finding (symptomatic patients seeking medical care) and active case finding through extensive fluorography screening programmes. Symptomatic cases are reported by doctors direct to the National TB programme based at the National Tuberculosis Institute “Chiril Draganiuc” (NIPP). Most notifications come from district TB services in rayons and municipalities, including the municipal TB hospital in Chisinau. Most cases are diagnosed or confirmed at the National Reference Laboratory at NIPP. Notifications included more detailed information than in the general surveillance system; the TB programme maintains a detailed computerised database of cases, and reports periodically to the Ministry, National Coordination Board, and NCPH (statistics). 2.7.5 Healthcare associated infection, antimicrobial resistance and antimicrobial usage Each hospital is required to have an operational plan for the surveillance and control of nosocomial infections developed in accordance with the national plan approved by the Ministry of Health. National guidelines for surveillance and control of nosocomial infections – including a section on protecting the health of care workers – have been developed and are in the process of being implemented. Hospitals have certain facilities for isolation of infectious patients in accordance with national standards and National Clinical Protocols. 23 Approved by the Government of the Republic of Moldova in 2010 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 23 of 95 Hospital epidemiologists, where available, are responsible for carrying out investigations, data analysis and reporting of nosocomial cases and outbreaks according to the standard protocols of the rayon/municipal Centre of Public Health. Data related to nosocomial and principal surgical infections is reported to the rayon CPH, and aggregated at the national level. No community and hospital surveillance systems for antibiotic resistance and antibiotic usage are in place. A monitoring system for antibiotic resistance was set up in limited number of hospitals. At the national level, for scientific research purposes, aggregated data regarding drug-resistant pathogens in hospitals are collected. Neither national coordinated surveillance nor national data are available. 2.8 Other surveillance systems (a) Immunisation surveillance Surveillance of childhood schedule vaccine uptake is undertaken on an ongoing basis, with birth cohorts for resident children as denominators. There have been no sero-epidemiology surveys in recent years to corroborate apparent community immunisation levels. Cases of measles are rare, one outbreak was reported in 2012 (see above). (b) Sentinel surveillance systems A number of sentinel systems are in operation, including surveillance of influenza and acute respiratory infection syndromes, rotavirus infection, and pneumonia in children under 5 years of age24. (c) Syndromic surveillance systems Apart from two of the sentinel systems above, no syndromic surveillance systems 25 are used in the Republic of Moldova. (d) Surveillance of special groups A number of surveillance and screening systems are in operation, which were not specifically assessed during this review. These include screening procedures for systems for particular occupational groups, returning travellers, migrants, refugees, prisoners. (e) Military, Police The Military and Police have their own healthcare and infectious disease systems. However aggregate data is submitted monthly to NCPH. These systems were not assessed during the present review. 2.9 System sensitivity and specificity 2.9.1 Sensitivity Sensitivity is a critical quality aspect for any surveillance system. Surveillance system sensitivity is defined as the proportion of actually occurring cases of infection that are known to the surveillance system (WHO 2006). As such, it is a function of the completeness of both ascertainment and reporting of cases26. 2.9.2 Apparent relative surveillance system sensitivity in Moldova 24 Sentinel surveillance ILI, ARI, SARI (MoH order on the improvement of surveillance system for influenza and acute respiratory infections nr.824 from 31.10.2011, http://ms.gov.md/legislatie?field_legtip_tid=16&=Caut%C4%83, sentinel surveillance on rotavirus infection (MoH order nr. 252 from 20.06.2008 on the implementation of sentinel surveillance for rotavirus infection in the Republic of Moldova, and MoH order 1238 from 07.12.2012 on the assessment of the impact the introduction of rotavirus vaccine, sentinel surveillance on pneumonia (MoH order regarding epidemiological sentinel surveillance of community acquired pneumonia in children under 5 years MoH order nr.1190 from 23.10.2013, http://ms.gov.md/sites/default/files/legislatie/ord._1190_din_23.10.3_supravegherea_epidem._pneumonii_comunitare.pdf 25 E.g. surveillance of defined syndromes in medical emergency care departments, surveillance of relevant ‘over the counter’ pharmacy drug sales, etc 26 Ascertainment relates to the proportion of actually occurring cases of infection in the country that are actually recognised and diagnosed by the health care system. There is no expectation for most diseases that ascertainment will approach 100%; for most diseases the proportion if cases recognised will be much lower, but for surveillance and public health purposes, it is important that the level of ascertainment be adequate for the public health purposes relevant to that disease (or disease group) and that it be reasonably consistent over time. Reporting refers to the communication of the information re a diagnosed case to the country’s surveillance system; there is no reason in principle why this should not be 100%, and this is the de facto standard. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 24 of 95 Table 4 compares the outputs from the Moldova surveillance system - in terms of the annual incidence of cases reported through it - with the median equivalent outputs from EU member states. Such comparisons do not of themselves indicate a sensitivity issue for the surveillance system, but, where large differences exist, it poses an apriori question for consideration by country leaders as to why it should be so. From the table it appears that the traditionally well recognised public health problems of TB, HIV, salmonellosis and shigellosis, VTEC/STEC, gonorrhoea and syphilis, are reported by the Moldova system at rates considerably exceeding the EU median, suggesting both the substantial dimensions of the actual public health problem, and the probable effectiveness of the systems for their recognition and reporting However, other diseases, recognised as public health issues in a European context, are reported by the system much less frequently than in EU member states; e.g. Campylobacteriosis, Yersiniosis, Hepatitis A; legionellosis; Chlamydia; invasive H.influenzae and S.pneumoniae infections. While it is theoretically possible that the actually incidence of these diseases is lower than in EU member states, the level of disparity suggests the presence of ascertainment and/or reporting issues that require further investigation. A number of diseases, which are required to be reported to EU level by Member States, have not been reported in the Republic during 2011-2013. These include (in decreasing order of frequency of reporting in the EU): campylobacteriosis, measles, legionnaires disease, listeriosis, brucellosis, West Nile virus infection, viral haemorrhagic fever (including CCHF) (see also chapter 3, microbiology). While in some cases this may reflect the true situation, in others failure of ascertainment and/or reporting is likely. For some diseases, it is noted that laboratory access and capacities is limited. Some of these relatively uncommon diseases are important from a public health perspective, either because of the potential severity of the infection (e.g. listeriosis, meningococcal disease), or their epidemic potential (e.g. measles, legionellosis, WNV infection). Some indicate potentially significant interactions with animal and occupational health (e.g. yersiniosis, brucellosis); others are emerging diseases in the South-East European region (e.g. WNV infection). Others are subject to elimination targets (e.g. measles). For these various reasons it is important to establish with reasonable certainty that these ‘zero reports’ reflect the true epidemiological situation, rather than the failure of health services to identify cases. 2.10 System coordination and integration 2.10.1 Coordination between national communicable disease systems As above, TB, HIV/AIDS, STI surveillance systems are administered independently of the main surveillance system. There is no data linkage between these systems, and each other or the general surveillance system. There are no or infrequent liaison meetings between epidemiologists administering these different systems. One consequence of the present arrangement is the effective exclusion of rayon epidemiologists from timely information about local epidemiology of these diseases (limited to annual high level reports from the respective agencies). 2.10.2 Coordination with other relevant national surveillance and information systems There is no data linkage between databases for human and veterinary infectious disease surveillance 27, or with surveillance of the new Food Safety Authority. In the case of a public health event originated by zoonotic diseases, the veterinary service reports data through an electronic surveillance system for animal traceability, which was developed to automatically exchange data with the public health electronic surveillance system; this exchange of information is no longer working. There is infrequent liaison, between system leaders at NCPH and at the Ministry of Agriculture (veterinary health), and the Food Safety Authority. 27 Although this is provided for by regulation Page 25 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Table 4 - Reported confirmed disease rates from surveillance systems, for selected diseases, Republic of Moldova, compared with EU/EEA Member States (mean crude rate), 2012 (Diseases reported at less than the 25% percentile reported rate for EU countries are indicated in red). Disease Moldova no reported cases 2012 Moldova rate confirmed cases 2012 EU Member States median rate: reported confirmed cases /100,000 2012 Tuberculosis 90.6 13.5 Legionellosis 0.0 1.1 Botulism 0.1 0.01 Brucellosis 0.0 0.08 Campylobacteriosis 0.0 68.3 Cryptosporidiosis 1.8 3.1 Giardiasis 6.2 5.4 - 0.2 Hepatitis A 0.1 2.6 Leptospirosis 0.1 0.1 Listeriosis 0.0 0.4 Salmonellosis 34.3 21.9 Shigellosis 13.3 1.6 Toxoplasmosis (congenital) 0.0 1.5 Trichinellosis 0.0 0.1 Tularaemia 0.0 0.2 Typhoid/paratyphoid fever 0.1 0.3 VTEC/STEC 6.4 1.5 Yersiniosis 0.0 2.0 Chlamydia 0.2 177.1 Gonorrhoea 32.6 9.3** Hepatitis B 1.6 3.3** Hepatitis C 1.9 7.4** HIV 13.8 5.7 AIDS 4.4 2.2 Syphilis 63.1 3.6** Respiratory diseases Food and waterborne diseases Echinococcus Sexually transmitted and blood-borne diseases Emerging and vector-borne diseases Page 26 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Dengue - 0.3 Hantavirus infections - 1.0 Malaria 0.8 0.9 Q fever 0.1 0.2 Tick-borne encephalitis 0.1 0.5 West Nile Virus infection 0.0 0.1 Invasive haemophilus influenzae 0.0 0.36 Invasive meningococcal disease 0.2 6.40 Invasive pneumococcal disease 0.0 3.63 Measles 0.3 2.2* Mumps 3.4 2.9* Pertussis 2.1 10.9* Rubella 0.1 7.9* Vaccine preventable diseases *total reported cases **2011 data “0.0” zero reported cases; “-“ no report. 2.11 International reporting and potential for case reporting to EU level Communicable disease statistics are supplied annually, on an aggregate basis, to WHO (CISID and EUROFLU). Detailed anonymised TB case reports are made to WHO on an agreed basis with ECDC. Detailed anonymised case reports for HIV and AIDS are made direct to ECDC (TESSy). Reporting to WHO under the International Health regulations are made as required and self-assessment system reports have been submitted annually according to WHO requirements. 2.12 System monitoring and evaluation 2.12.1 Previous evaluations or reviews (a) International organisations An holistic assessment of the Republic of Moldova surveillance system was completed by WHO in 2001 28. A selfassessment of public health functions in Moldova was completed in association with WHO in 201029. WHO Europe completed a review of the STD programme, in 2013 (and again, in association with the present review, in 2014). WHO also reviewed the national TB programme in 201330. (b) Internal reviews The Ministry of Health conducted an internal review of legislation compatibility with the EU acquis, in 2013. Otherwise there have been no internal evaluations of the surveillance and response system in the Republic of Moldova. 28 WHO, Regional Office for Europe. Assessment of the National Surveillance System for Infectious Diseases Republic of Moldova 19-31 March 2001. WHO, 2002 29 WHO, Regional Office forb Europe. Analysis of Public Health Operations, Services and Activities in the Republic of Moldova. WHO, 2012. 30 WHO, Regional Office for Europe. Review of the National Tuberculosis Programme in the Republic of Moldova. WHO, 2013. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 27 of 95 2.12.2 System sensitivity and data validity There have been no internal evaluations or reviews of the sensitivity of the surveillance systems, at a generic level. At a disease specific level, attempts to estimate true population size and system sensitivity have been undertaken under the HIV and STI programmes. 2.12.3 Internal data completeness and validity As described above, there is routine daily activity by rayon epidemiologists and staff checking the accuracy of case data, referring back to the doctors if necessary, as part of the surveillance case classification process. There is no regular monitoring of the completeness or timeliness of data supplied, at either rayon or national level, although this could be built into the operating specifications of the SAE. 2.12.4 Representativeness There have been no evaluations of the representativeness of the general surveillance system. Studies of reporting among risk groups are an integral part of the HIV and STI programmes. Page 28 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 SURVEILLANCE AND OUTBREAKS: STRENGTHS AND WEAKNESSES COMPONENT S1: LEGISLATIVE AND REGULATORY FRAMEWORK Strengths Nationally distributed and regulated passive surveillance system There is a national distributed passive surveillance system, with a clear and comprehensive legislative and regulatory framework, generally well accepted by both healthcare staff and public and generally good compliance with reporting. Strategic planning There are clear strategic plans for further development of the surveillance system in the context of overall public health development planning Outbreak reporting and response There are clear responsibilities and requirements for outbreak reporting, available 24/7 at local and national levels, with local PHS responses supported as required by a defined NPHS team WEAKNESS RECOMMENDATION S1.1 Surveillance objectives and priorities Although there are clear overall objectives for the effect of the systems for surveillance prevention and control of communicable diseases, there are no specific objectives related to the surveillance system (exceptions include some specific surveillance requirements for specific programmes, e.g. TB, HIV); Although prioritisation work has been completed for communicable diseases, this does not appear to have been integrated into policy and practice for the epidemiology services; most diseases are subject to the same reporting procedures, and there is little particular attention to the ‘priority diseases’ in the design of or priorities given to surveillance or control operations at local level The notifiable disease list includes diseases and syndromes of limited public health value: overwhelming the reporting system, diluting commitment of primary care doctors to reporting, and obscuring public health priorities The prioritisation of communicable diseases should be reviewed, with a view to integrating attention to priority diseases at all levels: national policy development and planning of preventive programmes and strategies; (further) development of national strategies for priority diseases where this is required or none exist, in collaboration as needed with veterinary and food safety sectors (e.g. food and waterborne diseases, vector-borne diseases, antimicrobial resistance) design and adjustment of reporting requirements, and development of analytical capacities and processes, to meet the needs of these programmes and strategies; integration into work processes and practices at rayon PHC level; focused training and continuing professional development on the public health management of these priority diseases for public health and healthcare staff The diseases subject to mandatory reporting should be critically reviewed, with deletion of diseases and syndromes which cannot be shown to have sufficient value for public health purposes to justify mandatory individual case reporting ; Consideration should be given specifically to: the specific surveillance needs and priorities of the various national disease programmes, and adapting information to be reported accordingly Page 29 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 making some diseases/syndromes subject to reporting only on a periodic aggregate basis; reducing the amount of clinical information requested on standard reports S1.2 Parallel surveillance systems: Parallel surveillance systems for HIV, STI, TB can create inefficiencies and/or reduced effectiveness; through either double reporting, or lack of timely communication of information (case or aggregate based as appropriate) to epidemiologists and others involved in leading or supporting the planning and implementation of prevention and care programmes, at both national and rayon level The integration of these systems into the overall surveillance system should be actively considered, with particular reference to: advantages related to efficiency and quality of system administration; improvement in data and communication linkages between the relevant clinicians and epidemiologists and staff at both rayon and national levels, for the purposes of development of prevention programmes as well as case and contact management; particular requirements related to personal data protection which may be needed for these disease cases (For individual diseases, refer component S4) S1.3 Liaison with veterinary and food safety systems There is inadequate liaison and information exchange between public health and veterinary and food safety services at both local and national levels - only rabies cases , or outbreak situations , are subject to adequate communication with the veterinary services Formal agreements arrangements should be established between public health and veterinary and food safety services covering: Regular liaison Regular exchange of surveillance information and reports Operating procedures and protocols related to infectious disease events and outbreaks (see also ch. 4) Exploration of potential objectives and content of potential data linkages S1.4 Personal data protection Personal data protection is well regulated, and understood by individual staff; however there are few operational processes and procedures at rayon PHC level to restrict access to case reports to those handling them or following up the cases; For some diseases individual named data is transmitted to national level; Rayon PHCs should have policies and procedures for limiting exposure of individual case reports to the minimum number of staff; Only anonymised (coded) data should be held at national level, including personal data related to TB cases TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Publication of statistical reports and maps including single cases can risk deductive disclosure of the individuals concerned, particularly for frequent local level and date specified reports. Page 30 of 95 Processes should be established for giving avoiding deductive disclosure of individuals suffering particular infections, particularly related to regular reports at district level; Public health staff (national and rayon level) should receive training related to deductive disclosure Page 31 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT S2: SURVEILLANCE INFORMATION SYSTEMS Strengths National surveillance case classification system A well-established31 national case classification system, coherent with EU reporting requirements 32 is applied to cases at local level by epidemiologists and support staff. Electronic surveillance information system An electronic pilot surveillance system is well established nationally, with good levels of acceptance by healthcare data providers and public health staff. Information system support for local communicable disease prevention and control work Electronic surveillance system offers considerable present and potential assistance to local epidemiologists re the work case and outbreak detection, validation, analysis, and for monitoring the performance of the surveillance system. Outbreak and high risk case alert system An alert system built into the electronic database, routinely flags possible outbreaks identified through indicator surveillance. WEAKNESS RECOMMENDATION S2.1 Dual paper and electronic reporting systems; electronic surveillance system still under ‘pilot’ status; The traditional paper based reporting system is still fully functional leading to unnecessary double work and impairing the ability of local public health services to focus on data validation, control and prevention activities; The pilot electronic IT system is currently used primarily for reproduction of historic33 aggregate reports; its potential for analysis based on national case definitions is not yet fully exploited, and it does not support data export for ad hoc statistical analysis; Guidelines and operational manuals for rayon/municipal epidemiologists to work with the electronic system are not yet available. Priority should be given to formal establishment of this pilot system, as soon as practicable, including necessary legislative and regulatory authority. While it is recognised that the IT system continues to evolve technically, the need for parallel paper reporting should be removed as soon as possible. Standard reports should also be developed and used that are explicitly based on the national case classification system SOPs for rayon/municipal epidemiologists to work with the electronic system should be developed. S2.2 Validation of case reports: Validation of case reports by local epidemiologists appears variable in practice: unspecified, manual processes, in some cases of limited precision (e.g. influenza related cases) 31 32 33 Operational manuals for rayon/municipal epidemiologists to work with the case classification system should be developed. 2007 Essentially identical to the case classification for reporting to EU level (2002), for all relevant diseases and health events. The present need for this is understood given the pilot status of the system. Page 32 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 S2.3 GIS support to rayon epidemiologists: While GIS is available as a tool for rayon epidemiologists as part of the electronic SAE system, the system is currently unable to support surveillance and outbreak detection through (confidential) identification of case locations at village and street level. The GIS system should be further developed to identify the distribution of the cases at village and street level, and available to both national and rayon level epidemiologists (with appropriate data protection arrangements) S2.4 Early warning and alert system: The early warning and alert module of SAE has aberration flags based on manually set parameters based on epidemiological judgement, rather than use of a statistically based algorithm. The GIS component of the system is limited to locality level, and the zone shading of cases numbers; does not indicate locations of individual cases to street level. This alert system should continue to be developed, as a priority; consideration should be given to: developing a more systematic basis for defining aberrant levels for ‘flags’ (e.g. statistically based aberration detection software) further enhancing the GIS capabilities down to individual case and street level (for strictly confidential internal use by national and rayon epidemiologists for prevention and containment purposes, with measures to avoid deductive disclosure) Page 33 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT S3: USE OF SURVEILLANCE INFORMATION SYSTEM Strengths Feedback of surveillance information In addition to monthly and annual hard copy reports, there is good use of PH institutions web sites at both local and national level for dissemination of information about both communicable diseases and their occurrence locally and nationally Analysis and use of surveillance information There is regular basic descriptive analysis and reporting of surveillance data, mostly at national level, with some more detailed analysis for annual and ad hoc reports, ongoing monitoring of possible disease clusters, and to support national policy development and planning, and monitoring of some national programme targets. WEAKNESS RECOMMENDATION S3.1 Limited use of surveillance data for national level public health functions: At national level analysis of surveillance data is primarily focused on outbreak detection and the annual report, with limited use to inform and support policy development and service planning, programme monitoring, applied research, national leadership in communicable disease prevention and control The capacity (human resources, time, skills) to analyse surveillance and other relevant (e.g. applied research) data for these purposes should be increased to enable sufficient support for these national public health functions; S3.2 Limited rayon level analysis and use of surveillance data: There is limited ability/expectation on local epidemiologists to analyse and use surveillance data to produce information for their intelligence needs and action; The analytical capacity and processes at both national and rayon levels should be improved: This should be continued and further developed, including: greater attention and resource commitment to data analysis and presentation of data as useful information that can be understood by health professionals and the public; information should be linked with performed or intended public health actions. S3.3 Surveillance system sensitivity gaps : Surveillance sensitivity (level of disease recognition/ascertainment and reporting) is critically low for some diseases, e.g. Campylobacter, Chlamydia, emerging diseases such as West Nile Virus, invasive meningococcal disease; For some important diseases, reporting is often late in the clinical course (TB, HIV). Other diseases are likely to be considerably underreported cf. comparable systems in some EU member The healthcare and surveillance pathways of the diseases identified as comparatively under-reported, or not reported at all, by the surveillance system, should be reviewed, to validate whether underascertainment is occurring, identify the healthcare and laboratory system issues, and plan remedial action accordingly TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 states, e.g. parasitic gastrointestinal diseases, yersiniosis, legionellosis, pertussis34 Some diseases required to be reported at EU level appear currently not reported at all by the RM system 34 Page 34 of 95 Pathways for identification and reporting of diseases required for EU level reporting, that have not been recognised at all by the system over the past three years, should be reviewed, as above. These sensitivity issues relate primarily to systemic health service and/or laboratory issues, rather than the surveillance system per se Page 35 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT S4: DISEASE SPECIFIC PROGRAMMES AND SURVEILLANCE Strengths Disease specific surveillance Well established parallel systems are in place for surveillance of TB, HIV, and sexually transmitted diseases.35 HIV The current HIV surveillance system provides long-standing data on the number of reported HIV cases and HIV prevalence data in pregnant women tested for HIV as part of ANC services. HIV prevalence and behavioural data in key populations have been collected in 2009 and 2013; size estimations of key populations have been done for determining prevention needs and assessing coverage with different services; system representativeness appears adequate from key populations; there is an infrastructure that would support electronic reporting of HIV cases, including CD4 counts at the time of HIV diagnosis. Sexually transmitted diseases Reporting of cases of syphilis and gonorrhoea appears to function well with reasonable sensitivity and representativeness; Prevalence estimates for syphilis and hepatitis B are available for several populations at higher risk of STIs; Two staff have been trained in laboratory diagnostics of STIs at the WHO collaborating centre in Sweden TB TB surveillance operates through a well-established web based passive reporting system, from hospital pneumologists to the national TB centre; Case information is available in real time, supporting joint control activities at local level between pneumologists, GPs and epidemiologists; Surveillance and monitoring at national level is compliant with WHO and ECDC requirements. Influenza A sentinel surveillance system is established nationally, looking to detect and identify influenza strains Immunisation Vaccine uptake reporting functions routinely and with apparent efficiency nationwide. WEAKNESS RECOMMENDATION S4.1 HIV surveillance and information The roles and responsibilities among institutions that participate in HIV surveillance are not well defined, shared and co-ordinated. The current fragmentation of HIV surveillance should be overcome. It is necessary that the National AIDS Programme of the Ministry of Health establishes a productive collaboration with key partners from other governmental institutions, academic institutions and NGOs. Capacities of the staff working on HIV surveillance at the national level (at the National Centre for Public Health and at the HDCD) need development, particularly in data use and interpretation. Staff working on HIV surveillance at the national level should receive training to develop their capacities in HIV surveillance and data interpretation. Improvements should be made to the reporting system: HIV case reporting system has limited usefulness in 35 HAI and AMR, immunisation surveillance not examined Page 36 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 providing data on the reported mode of HIV transmission since it severely under-estimates MSM transmission and probably over-estimates heterosexual transmission. CD4 count data are not analysed and presented in the routine surveillance reports. Some important bridging groups are not yet included in surveillance, such as sexual partners of PWID, clients of FSW and migrants, which limits the ability to interpret increases in sexual transmission from HIV case reports. There may be challenges with acceptability of HIV case reporting by infectious disease clinicians who are, since the year 2012, requested to report HIV cases to the National HIV Programme based at the HDCD. Data on the mode of HIV transmission were available for only approximately 40% of HIV cases reported in 2013. There is also unclear responsibility over reporting of cases of AIDS deaths. Epidemiologists at rayon or national level have no access to aggregate or anonymised data related to HIV cases, resulting in lack of intelligence for action re prevention and early diagnosis activities at district level. There is a need to bring in line HIV case definitions with those recommended by WHO and ECDC; HIV case reports need to be entered in an electronic database that should be based at the National AIDS Programme; HIV case reporting should be integrated into communicable disease case reporting system and should include data on CD4 counts. The validity of data on reported modes of HIV transmission in recently diagnosed HIV cases should be improved. Sexual transmission of HIV should be better understood, by identifying and carrying out surveys in groups at higher risk of sexually transmitted HIV, such as pregnant women, sexual partners of PWID, clients of FSW and migrants. Clinicians that report HIV cases need training, supportive supervision and should be given operational manuals on HIV case reporting in order to ensure better quality of data. In order to overcome a legal requirement which stipulates that electronic HIV case reporting database cannot be name-based, case reports should be coded with unique codes; There is a need to clearly define which institution is responsible for AIDS deaths reporting and to ensure greater completeness of data on AIDS deaths; Since epidemiologists at rayon level are in charge of developing HIV prevention interventions, HIV case reporting data should be shared with epidemiologists at least on a quarterly basis, as well as other HIV surveillance data. STI surveillance STI surveillance is not integrated into communicable disease surveillance system. STI surveillance should be integrated into communicable disease surveillance system. The case definition for gonorrhoea does not include asymptomatic infection, cases with infection at extragenital sites, or diagnosis based on nucleic acid amplifications tests (NAATs). Case definition of gonorrhoea should be brought in line with WHO, IUSTI and ECDC case definitions. Congenital syphilis is not a notifiable disease. Under-diagnosis and under-reporting of gonorrhoea is more likely than that for syphilis, since syphilis should be, diagnosed, treated and reported by dermato- Congenital syphilis should be a notifiable disease There is a need to improve the sensitivity of case reporting of gonorrhoea by collecting information on diagnosed cases outside of DV clinics. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 37 of 95 venereologists. It is unclear to what extent codes used in STI case reporting are unique to individual patients. The functioning and quality of STI case reporting based on unique codes should be reviewed and assessed. There is still mandatory STI screening of some occupational groups. Mandatory screening of occupational groups for STIs should be abolished. With exception of testing for syphilis, symptomatic male gonococcal urethritis and culture of Trichomonas vaginalis, the laboratory methods in use for STI diagnostics are generally not in adherence to international norms and guidelines. STI diagnostics should be improved with introduction of sensitive, validated and quality assured and controlled laboratory tests. There are no internationally published studies regarding gonococcal antimicrobial and no valid antimicrobial resistance testing or resistance data for N. gonorrhoeae. Laboratory diagnosis of Chlamydia trachomatis infection used antibody detection for diagnosis of uncomplicated chlamydial infections. Some level of quality assurance and control system was available at all visited laboratories where STI diagnostics is done. While there appears to be substantial progress made towards elimination of congenital syphilis, there is no process established to validate this. Antimicrobial resistance testing for N. gonorrhoeae should be established, and studies carried out to establish the epidemiology of AMR in N. gonorrhoeae in Moldova. Antibody detection methods for diagnosing genital chlamydial infection have highly suboptimal sensitivity and specificity and should not be used to diagnose acute uncomplicated C. Trachomatis infection. A complete quality assurance system should be established in the key laboratories where STI diagnostics is done. The Ministry should request from WHO initiation of the process for validation of elimination of congenital syphilis. TB surveillance TB surveillance continues to operate in parallel to the main surveillance system, limiting information to and involvement of rayon epidemiologists and staff in disease prevention and control activities at local level; benefits of the SAE in terms of real time reporting, analysis and outbreak detection are not available to TB programme The present agreement in principle regarding integrating TB surveillance into the general surveillance system should be investigated, to identify its benefits in support of effective Tb control and treatment compliance at rayon and municipal level, and to identify additional data protection measured that may be necessary. Page 38 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT S5: PUBLIC HEALTH WORKFORCE Strengths Workforce A dedicated and disciplined professional epidemiological and microbiological workforce, familiar with the legislative and regulatory framework for their service. Public health procedures and protocols Protocols and standard operating procedures (SOPs) for epidemiologists and support staff are in place for several important epidemiology service functions. Epidemiology unit infrastructure Generally adequate staff working conditions with good access to computers, information systems, other necessary equipment, and internet connectivity. WEAKNESS RECOMMENDATION S5.1 The epidemiology workforce: The epidemiologist workforce is ageing, and it is not clear that sufficient doctors are being recruited to the specialty training programme and retained/appointed to epidemiologist posts related to communicable disease control to maintain the present workforce over the medium term; Attention should be given as a priority to: forward planning and strategic management of the impending crisis in the epidemiologist workforce (through expected retirements); A strategic plan based on careful monitoring of human resources and assignment of responsibilities should be developed by the Ministry in conjunction with education and training authorities; Consideration should be given to the increased use of nonmedical staff in epidemiology services, and to the adjusting the present required activities of specialist epidemiologists. There are unfilled vacancies for epidemiologists, particularly at rayon level; Epidemiologists perform some routine activities that could be performed by staff with less specialist training (both clinical, e.g. nurses, and nonclinical, e.g. MPH or IT graduates). Epidemiologists carry out many reporting activities for statistical purposes with little apparent public health use. S5.2 Outbreak management lacks analytical investigation: Outbreak investigations are still patient oriented, offering few elements on descriptive and little in terms of analytical investigation; Reporting of outbreaks is mandatory, but the quality of outbreak investigations and response is not adequately monitored. Training and continuing education programmes should be provided to strengthen the continuing professional development of epidemiologists particularly related to use of analytical methods in outbreak investigation, surveillance and development of prevention programmes. Professional guidelines and Standard Operating Procedures (SOPs) for outbreak investigation should be further updated and developed. Incident reviews of (at least a sample of) outbreaks, including their management, should be regularly undertaken, for benefit of learning of epidemiologists and staff nationwide. Page 39 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 S5.3 Analytical epidemiology skills of rayon epidemiologists and support staff: Rayon epidemiologists and support staff appear to lack, and/or do not have time or resources to apply modern skills in both descriptive and analytical epidemiology,, to support both surveillance and investigation of outbreaks; In-service training and continuing professional education programmes should be provided for epidemiologists and support staff; The programme of developing and updating protocols and SOPs for public health staff should continue, and be extended to cover all important aspects of public health practice at district and national levels; Particular attention should be given at rayon level to protocols/SOPs relating to: outbreak investigation analysis and use of surveillance data validation of surveillance case classification procedures S5.4 Continuing professional development Few of the continuing professional development (CPD) activities/events presently available to medical specialists, including epidemiologists and microbiologists, (as well as general practitioners and hospital doctors, who need to keep up to date), appear to relate to communicable disease prevention and control (apart from vaccination); CPD programmes for epidemiologist support staff appear to be limited. CPD programmes should recognise the need for continuing professional development in the field of communicable diseases prevention and control, and provide training opportunities accordingly, for both public health and healthcare staff; Epidemiologists should be expected, and supported to have, CPD activities related to communicable disease prevention and control, and relevant skills (eg statistical analysis). CPD programmes should be developed for public health support staff; Where CPD programmes for both epidemiologists and support staff, are deficient related to needed skills for the epidemiology service (e.g. in surveillance and outbreak investigation), they should be complemented by in-service training. Use international opportunities to support further training of epidemiologists (e.g. MediPIET) and develop national capacities for training public health specialists in the field of intervention epidemiology. Page 40 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT S6: SUPPORT TO WIDER HEALTH SERVICE Strengths Guidelines and training for clinicians A well-developed programme of clinical and public health guidelines is in place, for most diseases of public health significance, below the level of (but supported by) ministerial regulation, available to doctors and other health service staff. Training programmes, particularly for family doctors, are well established WEAKNESS RECOMMENDATION Guidelines and training for clinicians: The guidelines programme does not cover all infectious diseases of public health relevance, public health management aspects are sometimes underdeveloped, and some guidelines need updating Training programmes, particularly for family doctors, are well established, but with little attention to public health management of infectious diseases considered This important programme of work should be maintained, supported and extended; particular attention should be given to: further increasing the technical areas where healthcare staff can be supported through guidance without requirement for ministerial regulation or decision; consideration should be given to extracting, consolidating and promulgating public health management guidelines as a national Communicable Disease Public Health Handbook; Training of clinicians should be ensured, at both national and rayon level, that includes public health and communicable disease public health management competencies (in addition to existing continuing professional, education on clinical subjects). TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 3 Page 41 of 95 Public Health Microbiology System 3.1 System Overview Laboratory services for both diagnostic and reference purposes are provided primarily by a network of laboratories under Centres for Public Health, at rayon, municipal and national level. The primary legal framework underpinning laboratory surveillance is the 2013 MoH order regarding the implementation of the programme for development of the state surveillance public health laboratory network in the Republic of Moldova36. 3.2 Primary diagnostic laboratory services 3.2.1 Diagnostic services Moldova has the laboratory diagnostic capacity to confirm cases according to the EU case definitions for all diseases under EU surveillance except for those indicated in chapter 2. Primary diagnostic services are provided by: Laboratories of the Centres for Public health (CPH) in rayons and municipalities: these laboratories are authorised by the Minister of Health to carry out laboratory investigations on causative agents of communicable diseases under national surveillance. National reference laboratory (NRL): the NRL at Chisinau also provides primary diagnostic services, e.g. for virological testing and “dangerous pathogens”. Private laboratories: there are also a small number of private laboratories in Moldova, located mainly at private clinics. Such laboratories are reported to perform diagnostic testing for sexually transmitted diseases including HIV/AIDS. However, it is not clear if and how they are reporting (see chapter 2, HIV, STD surveillance). 3.2.2 Range and scope of diagnostic tests The majority of primary diagnostic services, for both family doctors and hospitals, are provided by CPH laboratories, making them also the prime source of microbiological data for surveillance. They include mainly basic bacteriology and parasitology investigations (light microscopy for Giardia lamblia and helminths), and ELISA (screening tests) for HIV. There is very limited capability in the field of virology (serological testing is 99% performed for HIV screening, the remaining 1% is mainly performed for research purposes). Real-time PCR machines are few, and often dedicated to an individual disease (e.g. influenza). There is no capacity to sequence/perform full genome typing. 3.2.3 Antimicrobial resistance testing There is no community and hospital surveillance system for antimicrobial resistance (AMR) and antibiotic usage are in place. A monitoring system for antibiotic resistance was set up in a limited number of hospitals. For example, antimicrobial susceptibility testing is performed for Salmonella only at the national level. Clinical breakpoints as described by the Clinical and Laboratory Standards Institute (CLSI) are used for antimicrobial susceptibility testing, data interpretation and reporting37. 3.2.4 Referral systems Should the laboratory located at the rayon/municipal CPH be unable to diagnose a suspected case, or be in the need of confirmatory diagnostics, it may refer patient samples to the respective national reference laboratory. No charge is levied for referral of samples. For some pathogens, referral is required by regulation. 3.2.5 Capacity and infrastructure Operational conditions of clinical microbiology laboratories, including provision of adequate staffing, space and equipment, are regulated by national ordinance.38 There appears to be limited capacity for timely sample transportation from clinicians to the laboratory, particularly outside the rayon centre. CPH laboratories have capacity for pre-analytical preparation of samples for serological testing and sample storage. 36 37 38 http://www.cnsp.md/down/info1371468083ro.pdf http://clsi.org/blog/2012/01/13/clsi-publishes-2012-antimicrobial-susceptibility-testing-standards/ Ordinul Ministerului Sănătăţii nr. 668 din 10 June 2013; http://www.cnsp.md/down/info1371468083ro.pdf TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 (a) Page 42 of 95 Human resources Public health laboratories at rayon/municipal level are led by microbiology technicians who are university graduates, with continuous professional education in microbiology, and supported by microbiologists from NCPH. Staff appear dedicated and well-motivated, with a good knowledge of diagnostic tests available. (b) Buildings and equipment The laboratory space within the public health centres appears generally sufficient: an average microbiological laboratory space of 275m2 and Sanitary Hygienic Laboratory space of 183m2 is regulated39. The microbiological laboratories of municipal centres visited (Chisinau, Cahul, Ungheni), are generally well equipped for the range of tests that they perform. Rayon microbiology facilities have been recently upgraded via World Bank funding. Modern equipment has been provided by several international donors (e.g. World Bank, EC, WHO, CDC) including MicroScan Walk Away automated microbiology systems for bacterial pathogens, Phoenix 100 ID/AST system for identification of Enterobacteriaceae and commonly isolated glucose non-fermenting gram negative bacilli (automated system for identification and antimicrobial resistance testing), as well as class 2 biosafety cabinets, refrigerators, ultracentrifuges, and autoclaves. The sanitary hygiene laboratories have more basic, rather out-dated equipment. (c) Supplies and procurement Laboratories at both local and national level frequently lack reagents to perform requested diagnostic tests – procurement is intermittent. The modern equipment requires specific consumables. (d) Laboratory information system While laboratories in public health services are connected to SAE with test results immediately available on SAE, some clinicians are not connected to the internet so there is still paper based reporting of laboratory test results done in parallel. Private laboratories are not connected to the laboratory information system. 3.3 Reference microbiological diagnostic services 3.3.1 Formal recognition No formal procedure for nomination of national reference laboratories is in place. 3.3.2 Primary diagnostic services The reference laboratory at NCPH performs primary diagnostics for rare, difficult to culture, and dangerous pathogens, as well as other common pathogens. Diagnostic services are provided for both hospital inpatients and outpatients, as well as for family doctors. Serologic and molecular diagnostic methods are used for: Viral infections: hepatitis, HIV / AIDS, rotavirus, herpes virus (ELISA and PCR). Respiratory infections: influenza, SARS, parainfluenza, adenovirus, RS virus (ELISA and PCR). Parasitic infections: Cysticercosis, Echinococcosis, Trichinellosis, Toxocara, Toxoplasmosis (ELISA) Bacterial infections: Mycoplasma, Chlamydia, bacterial meningitis, Salmonellosis, Shigellosis, Yersiniosis, Escherichia coli, Campylobacter, Listeriosis (ELISA and PCR). Vaccine preventable diseases: Rubella, Rubeola, Measles, Diphtheria, Tetanus (ELISA). Dangerous pathogens: Brucellosis, Tularaemia, Anthrax, Leptospirosis, Q-fever, West Nile fever (ELISA and PCR). Virological diagnostic capacity is very limited. There are few real-time PCR machines available, and these are usually exclusively dedicated to individual diseases (e.g. influenza). There is extremely limited capacity to perform molecular typing, and no capacity to perform gene sequencing. 39 Decision Nr. 668 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 43 of 95 3.3.3 Characterisation and reference services Reference diagnostics provide confirmatory diagnosis of samples sent from primary laboratories across the country. These include isolation and characterisation of human pathogens, including determination of virulence factors. There is capacity (methods not specified) to perform molecular typing of Salmonella, VTEC and Listeria. Scientific advice provided includes guidance on diagnostic methods/practices, disease/pathogen specific guidance; national guidelines for clinical laboratory practice. 3.3.4 Referral systems (national and international) A national referral system exists for referral of certain samples from public health laboratories to Chisinau (e.g. primary testing (ELISA) for HIV is performed in the public health laboratories and then referred for molecular testing/confirmation). Although there are much international collaboration established within surveillance and research networks, there are no formal international referral arrangements in place. Examples of international collaboration include: CDC o Rotavirus vaccine effectiveness o Norovirus, and hepatitis viruses WHO o Influenza - WHO reference laboratory for influenza, exchange of information, sentinel site, sending of isolates to the WHO collaborating center in London o Polio - WHO reference laboratory for polio o Rubella and measles (WHO reference laboratory, Moscow) EU Networks o Danish veterinarian institute (SalmSurv) o Romanian institute Twining project Black sea network; o o Laboratories in Moscow and in the Saratov university (e.g. arboviruses) Pact for stability for public health problems (AMR, TB, HIV working groups). 3.3.5 Other reference services (a) Training Training is regularly conducted both for staff of the reference laboratory and for staff of the public health centre laboratories on the routine tests performed. There is limited training of laboratory personnel on new test methods. (b) Scientific advice Scientific advice provided by the NRLs includes guidance on diagnostic methods/practices (e.g. disease/pathogen specific guidance; national guidelines for clinical laboratory practice). (c) Information to the public Information to the public is provided both at both rayon national level in collaboration with the epidemiologists (e.g. on preventive measures and recommendations for implementation of specific control measures). 3.3.6 Capacity and infrastructure (a) Human resources The NRLs at NCPH are led by specialist medical microbiologists, supported by microbiology technicians (see chapter 1). (b) Buildings and equipment Both the Laboratory for Dangerous Pathogens and the Reference Laboratory for Microbiology within the NCPH at Chisinau are located in a rather run down building with old, partially obsolete equipment. The Laboratory for Dangerous Pathogens includes a biosafety 3 facility (glovebox). It has capacity to work with small animals (rodents, mosquitoes etc), and maintains its own animal facility. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 44 of 95 There are some extant security problems, e.g. the access to the dangerous pathogen laboratory is not secured (normal door/lock). Access to the rooms at higher biosafety level/BSL3 glove box is restricted and under video surveillance. The Center for Virology (for respiratory and gastrointestinal infections) is located in a new building with new equipment (real time PCR, serological testing, and isolation). The Influenza, measles and Polio laboratories are WHO accredited and participates in regular international EQAs/proficiency testing. They have all necessary equipment and a dedicated room for egg inoculation, but (as yet) no eggs. (c) Supplies and procurement Laboratories frequently lack reagents to perform requested diagnostic tests, due to intermittent procurement. (d) Laboratory information system The reference laboratories have all access to computer/ internet. 3.4 Laboratory activity reporting Annually extensive activity reports (“passports”) are produced by all the 36 public health laboratories. These are aggregated into the Annual Laboratory Activity Report by the National Reference Laboratory. The microbiology data in the report are primarily descriptive showing the number and type of tests performed by region/municipality. Analytical data (e.g. resistance trends) are shown for selected pathogens or health issues, such as HIV/AIDS, Tuberculosis and antibiotic resistance. 3.5 Integration with surveillance systems and other sectors 3.5.1 Reporting of infectious disease cases Reporting of microbiological test results as part of the national case reporting is outlined in chapter 2. Public health laboratories performing microbiological testing have access to the real-time electronic reporting system in place and report according to the national regulations. The system provides a good link between clinical, epidemiological and laboratory data. The feedback of results to clinicians is appreciated for diagnosis and therapy, and the system is well accepted. Some reporting is done in parallel on paper as still some clinicians have no access to the internet. 3.5.2 Liaison with epidemiologists and public health units In the Centres for Public Health, both on the municipal and the national level there is a good liaison between microbiologists and the epidemiologists. A consensus workshop was held in 2007 consolidating the links between clinicians, laboratories and the epidemiology services. 3.5.3 Liaison with other sector laboratories Collaboration between human pathogen laboratories mostly occurs on ad hoc basis with most laboratories not being integrated into national laboratory networks. There are only national networks on TB and HIV. Collaboration with private laboratories both for research and health emergencies appears limited. (a) Veterinary Veterinary services have one national and three regional laboratories. There is no data linkage with human surveillance systems. Collaboration with the laboratories of the Ministry of Agriculture are limited, both for research and health emergencies. Good collaboration appears to be established relating to suspected rabies cases. Collaboration relating to e.g. anthrax, brucellosis, tularaemia takes place only at national level. At the municipal level, staff appear unfamiliar with diseases such as West Nile virus. (b) Food Liaison with the newly established National Food Safety Agency as well as with the Consumer Protection Agency under the Ministry of Economy appears limited roles and responsibilities need to be clearly outlined and procedures agreed upon. There is the capacity to detect the following bacteria in food (ELISA): E.coli (O157), Listeria monocytogenes, enterotoxin producing Staphylococci. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 (c) Page 45 of 95 Environment The control of environmental hazards is divided between different authorities which lack coordination and cooperation. Each authority has its own laboratory network doing analysis of environmental health hazards. The Public health laboratory carries out investigations for the detection and confirmation of public health threats, however, lacking up-to date equipment and qualified personnel. The Ministry of Health is responsible for developing the legislation on air quality and environment protection. The testing of environmental samples collected with the purpose of monitoring risk factors is carried out mainly by three laboratories: the NCPH lab, and those of the Centres of Public Health in Chisinau and Balti municipalities. (d) Potable water The Minster of Health is responsible for developing national legislation in relation to drinking water and in collaboration with the Ministry of Environment for developing the legislation on sewage and discharge of waste and residues. There is capacity for the detection of the following bacteria in drinking water: E. coli, E. faecalis, Clostridium perfringens, P. aeruginosa, S. aureus. 3.6 Integration with alert and response systems 3.6.1 Overview Authorised laboratories of the public health institutes should perform the laboratory examinations in the event of an epidemic of infectious diseases. If laboratories identify any unusual event of potential public health impact as of their routine work, they are obliged to promptly report this to the national centre of public health. At the national level trends of microbiological findings are analysed. Monitoring for detecting new and/or emerging pathogen strain characteristics is done by some of the NRLs (e.g. influenza, measles, polio). There is a system in place to allow reporting of unusual events of potential public health impact (as detected by analysis of laboratory results) such as: Cases of pathogens with new profile/determinants of antimicrobial drug resistance; Cases of pathogens with new or unusual virulence profile; Clusters in time/area of isolates/case of common genotype; Increased occurrence of pathogens or increase in antigenic type distribution; However, there is very limited capacity to detect rare and/or emerging strains/pathogens as they will escape testing with standard methods applied. The capacity of the public health laboratory network to investigate health threats is especially weak in terms of detection and confirmation of toxic and radiologic agents. 3.6.2 Role in outbreaks The role of the laboratories in potential epidemics is outlined in the national legislation and is covered during the training/specialisation in microbiology. Reference microbiology laboratories may participate in outbreak investigations. Assistance from national level is given to regional level laboratories if needed. In most cases however, the outbreak control team at regional level is considered competent enough to perform investigation on differential diagnoses using its own public health laboratories; however, this can only be the case for bacteriological agents. Inter-sectoral table-top exercises and drills for rapid response teams involving the national laboratory network are provided annually by the CPESS and MoH. 3.6.3 Sentinel surveillance Laboratories participate in sentinel surveillance systems for ILI, ARI, SARI, rotavirus infection40 and childhood pneumonia41 (see chapter 2). 40 (MoH order nr.252 from 20.06.2008 on the implementation of sentinel surveillance for rotavirus infection in the Republic of Moldova, and MoH order nr.1238 from 07.12.2012 on the assessment of the impact the introduction of rotavirus vaccine) 41 (MoH order regarding epidemiological sentinel surveillance of community acquired pneumonia in children under 5 years MoH order nr.1190 from 23.10.2013 http://ms.gov.md/sites/default/files/legislatie/ord._1190_din_23.10.3_supravegherea_epidem._pneumonii_comunitare.pdf) TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 46 of 95 3.7 Laboratory regulation and standards 3.7.1 Regulatory mandate Public health laboratories operate under the mandate of the MoH order regarding the implementation of the Programme for development of state surveillance public health Laboratory Network in RM42. 3.7.2 Quality systems (a) Internal quality assessment systems All public health laboratories have internal quality assurance programs. The performance of results is assessed through inter-laboratory comparison of results. Guidelines, SOPs/quality manuals are developed by each laboratory to address handling, analysis and evaluation of the samples. (b) External quality assessment systems The NCPH organises annually national external quality control programmes for microbiological, sanitary-hygiene and radiological laboratories. The NRLs on influenza, polio and enteric pathogens, measles and rubella regularly participate in international quality assessment schemes for diagnosis and pathogen characterization. The Reference Laboratory for Microbiology has excellent results in international panels for measles and rubella. (c) Accreditation All public health laboratories are accredited every five years by the National Council for Evaluation and Accreditation in Health (CNEAS) in accordance with standards developed by the International Organization for Standardisation (ISO)43. Three laboratories (NCPH laboratory, CSP Chisinau and CSP Ceadar Lunga) are accredited by the Accreditation Centre Product Conformity Assessment (CAECP)44. CAECP performs annual external quality control accreditation of laboratories for surveillance. Quality management systems are in place in accredited laboratories. NCPH laboratories have accreditation by WHO e.g. for the diagnosis of polio, rubella, measles and influenza. 3.7.3 Biosafety (a) Biosafety levels Most human microbiology laboratories are at biosafety level 2 (BSL2). BSL3 facilities operate at the National Centre for Public Health in Chisinau (Dangerous Pathogens Laboratory). (b) National administration of biosafety There appears to be no national system for the regulation of biosafety in primary and secondary microbiology laboratories. The National Commission for biologic security established through the law nr 755-XV from 21st of December 2001 on biological security executes only authorisation and control duties of activities involved in process of obtaining, testing, producing, using and marketing of genetically modified microorganisms, plants and animals through modern biotechnology45. No national authority is responsible for developing and monitoring the implementation of biosecurityand biosafety standards. The existing guidance on laboratory biosafety is essentially the translated version of the WHO laboratory biosafety manual, 3rd edition) 201146 . Guidance on “Regulations for the Transport of Infectious Substances and Biosafety” was 42 MoH order nr.668 from 10.06.2013, http://www.cnsp.md/down/info1371468083ro.pdf ISO 17025 and ISO 15189 44 ISO 17025 45 According to the Regulation of organization and functioning of the nominated Commission approved by the Government decision nr. 603 from 20th May 2003. 46 http://www.cnsp.md/down/info1310369288ro.pdf 43 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 47 of 95 approved in 2011, and is applied, and training given47. There are international sample shipment providers/couriers, which can ship highly infectious substances in accordance to the international biosafety regulations (but at high costs). 3.8 Training and continuing education microbiologists and technical staff Specialist training and continuing education for microbiologists was not assessed during this country visit. It was noted that international training (e.g. seminars, courses, workshops, twinning programs) is rarely available for laboratory staff other than for national laboratory heads (due to lack of dedicated funds). 47 http://www.cnsp.md/down/info1310369463ro.pdf Page 48 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 PUBLIC HEALTH MICROBIOLOGY: STRENGTHS AND WEAKNESSES COMPONENT L1: PRIMARY DIAGNOSTIC LABORATORY SERVICES Strengths Diagnostic services of rayon and municipal laboratories: An adequate range of basic bacteriology services is provided for both primary care and hospital clinicians. Equipment and estate infrastructure of municipal level laboratories Facilities and equipment are modern and adequate for the range of tests performed. Problem Recommendation L1.1 Sustainability of diagnostic services Maintenance of current laboratory investigation capabilities with limited human resources is a continuing difficulty. Many currently used diagnostic tests rely on classical, laborious, time consuming technologies. Consideration should be given to progressively increasing the use of other test systems (e.g. rapid diagnostic test systems) and processes (automatisation). Validated rapid test kits could be used for rapid laboratory diagnosis in field investigations. Page 49 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT L2: REFERENCE MICROBIOLOGICAL DIAGNOSTIC SERVICES Strengths National Reference public health functions NRLs provide a range of services consistent with the core functions of NRLs outlined in the ECDC technical guidance;48 Legal mandate for confirmatory testing for surveillance For a selected number of diseases, national legislation obliges primary testing laboratories to forward clinical samples to the national level for confirmation; Microbiology reporting system The current laboratory reporting system provides a real-time overview of most of the pathogens diagnosed by the national laboratory system, including the possibility to monitor trends in pathogen characteristics. Problem Recommendation L2.1 National reference laboratory (NRL) mandate and nomination Mandate and core functions of NRLs are not formally defined. There is no selection or review process of candidate providers based on objective proficiency and performance criteria (evidence based nomination); NRLs should be nominated: Based on demonstrated capabilities and performance (by e.g. successful completion of external quality assessment rounds and/or accreditation using national/international standards), Under defined terms of reference (such as these promoted by ECDC in the Core functions of microbiology reference laboratories for communicable diseases”, June 2010 For a defined period of time, implying revision of capabilities and quality of services before possible re-nomination. L2.2 Sustainability of good quality NRL services Sustainable good quality laboratory services depend on continuous financial support, compliance with confirmatory testing, and a critical throughput of appropriate primary and referral test requests. The financing of NRLs should be sufficient to ensure uninterrupted provision of requested laboratory services (e.g. logistics of reagents supply); The use of joint diagnostic and reference microbiology applied research projects could be promoted as a funding source for increasing referral of samples and clinical isolates. NRL facilities appear outdated and the equipment is partially obsolete. Funding for test reagents is neither sufficient nor consistent to enable continuing procurement without gaps. 48 NRLs should be appropriately re-equipped and renovated to meet current generally accepted standards; Measures should be investigated to maintain and increase the referral of samples isolates to NRLs for confirmatory testing; ECDC technical report “Core functions of microbiology reference laboratories for communicable diseases”, June 2010. Page 50 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 L2.3 Biosafety at NRLs There is no obligatory certification for biosafety compliance. Laboratory staff should be trained regularly to increase biosafety awareness and compliance; There is no regular auditing, exercises and training of staff in biosafety (both expert and support personnel, including cleaning and maintenance staff). A national system for certification of laboratory biosafety compliance should be considered. Such a system could include provision for auditing and training. A bio-safety officer at national level could be appointed to oversee this activity; Access to the BSL3 laboratory should be continuously monitored. L2.4 Maintain laboratory testing capabilities with limited human resources Many current diagnostic tests rely on classical laborious time consuming technologies. Consider to progressively increase use of other, including automated, test systems (e.g. rapid diagnostic test systems) and processes. Page 51 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT L3: LABORATORY SERVICE QUALITY Strengths Competent and dedicated workforce Staff at the public health laboratories is dedicated and highly motivated. At both municipal and national levels, staff has a good knowledge of diagnostic tests available. The heads of the public health laboratories visited are university graduates, continuous professional education in microbiology. Some of the staff in the NRLs is involved in international surveillance and research projects. Quality of NRLs Some of the NRLs are internationally accredited (Influenza, polio, measles and rubella) and participate regularly in external quality assurance, with very good results. Some serve as WHO national reference centres. Problem Recommendation L3.1 Sustainability and development of microbiology expertise There is a decline in medical graduates specialising in Medical Microbiology and little evidence of involvement of other scientifically trained experts (e.g. molecular biology, biotechnology, bioinformatics) in NRL functions (e.g. data analysis, research and method development). Recruitment into the specialty should be developed, and the attractiveness of a relatively long specialisation should be enhanced. Possible contributions could include: increased involvement of medical microbiologists in epidemiological investigations and preparedness and response activities; opportunities offered by the ECDC supported EUPHEM training scheme; education activities of learned societies in clinical microbiology; Non-medical microbiology staff could be more involved in applied research at the NRLs (e.g. new method development and validation). L3.2 Antimicrobial susceptibility testing EUCAST breakpoints are not used for antimicrobial susceptibility testing as required by case definitions for reporting to EU level. Antimicrobial susceptibility testing should be aligned with the EUCAST methodology and interpretation criteria, including breakpoints.. Page 52 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT L4: INTER-PROFESSIONAL AND INTER-SECTORAL COLLABORATION Strengths Good public health collaboration There is a good collaboration/ communication between epidemiologist and public health microbiology staff within the Public Health Centres. Microbiologists are involved in outbreak investigations as members of multidisciplinary outbreak teams. Technical advice is provided on appropriate microbiological sampling, sample transportation and sample testing procedures as well as interpretation of specialized test results. Good international collaboration There are active international public health and research collaborations on a variety of agents with many international partners. Problem Recommendation L4.1 Inter-sectorial collaboration There are limited collaborations with environmental testing laboratories and veterinary laboratories both on public health and research. Improve inter-sectoral collaboration between services and laboratories at national level, (e.g. regarding sharing of data, information, and reports; explore potential for data linkage of surveillance systems); Increase knowledge of veterinary epidemiologists and microbiologists regarding emerging infectious diseases (e.g. West-Nile virus). L4.2 Business continuity There are no generators ensuring continuous function of microbiological equipment Procure back up power sources for national reference laboratories. L4.3 Clarity of laboratory role in national communicable disease emergencies The national emergency plan does not mention laboratories (see chapter 4). The role of laboratories in communicable disease outbreaks should be integrated into national health emergency plans. Simulation exercises could be conducted to test roles and responsibilities of NRLs and other public health microbiology laboratories, including surge testing capacity in the case of a major outbreak of a communicable disease. Page 53 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 4 Public Health Emergency Preparedness, Response and Crisis Management 4.1 Systems Overview The Republic of Moldova has in recent years developed a substantial body of legislation and capacities for a solid public health preparedness and response system, with shared responsibilities between civil protection and public health. The system, and particularly the public health component, has taken good advantage of international support in modernising a structure inherited from past administrations and built on a wide multi-sectorial network from central down to local level to prepare and respond to emergencies and disasters to which the country is prone. The Public Health system (at both national and rayon levels) were significantly re-organised in 2010, and is now being adapted to reflect the new Public Health Strategy 2014 -2020. 4.2 Past crises and potential threats The database of the Centre for Research on the Epidemiology of Disasters (CRED) lists epidemics, floods, extreme temperatures, windstorms and drought as the natural disasters that are responsible for the highest mortality rates and have the greatest adverse effect on large numbers of the population in the Republic of Moldova. Table 5 - Most significant natural disasters occurring in the Republic of Moldova in terms of death and population affected, 1990–2014 Category Event # of Events Killed Total Affected Damage (000 US$) Drought Drought 3 2 216194 406000 0.7 72064.7 135333.3 - 1647 - - 1647 - 10 7374 - 10 7374 - 13 - - 13 - - 10 4457 54832 3.3 1485.7 18277.3 51 47500 307752 12.8 11875 76938 - 2600000 31600 - 2600000 31600 3 25580 - 3 25580 - ave. per event Epidemic Bacterial Infectious Diseases 1 ave. per event Extreme temperature Cold wave 1 ave. per event Extreme winter conditions 1 ave. per event Flood Unspecified 3 ave. per event General flood 4 ave. per event Storm Unspecified 1 ave. per event Local storm ave. per event 1 Created on: Apr-2-2014. - Data version: v12.07; Source: "EM-DAT: The OFDA/CRED International Disaster Database; www.em-dat.net - Université Catholique de Louvain - Brussels - Belgium" TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 54 of 95 4.3 Management of Public Health emergencies The National Public Health Strategy 2014-202049 outlines a new approach in public health in Moldova (see chapter 1). In particular, the legal framework in the area of public health emergencies is to address priorities, gaps and outcomes for the development of an integrated, all-hazard public health emergency preparedness framework. The Strategy is accompanied by a detailed Plan of Actions with specific objectives and tasks related to the strengthening of preparedness and response to public health emergencies. Of particular relevance are: Task 2.1.6: Adjustment of the legal framework (regulations, standards, guides, indications and methodological recommendations) on public health emergencies of chemical, biological, radiological origin to the international standards; Task 2.1.8: Establishment and implementation of the National Integrated System of health sector preparedness and response to public health emergencies; Task 2.1.12: Periodical training of the intervention teams on planning, preparing, estimating the needs and vulnerabilities, evaluating, managing and communicating the risks, and post-intervention evaluation. Cross-cutting activities include responsibilities for inspection, monitoring, and enforcement, shared between the newlyestablished National Food Safety Agency (NFSA), under the Government authority, the SPHSS under the Ministry of Health and the Consumer Protection Agency (CPA) under the Ministry of Economy. The existing legislation and related regulations appear to be in line with the EU legislation. 4.4 Regulatory basis The preparedness for, response to, and recovery from public health emergencies is a shared responsibility at government level, between civil protection and public health. There is a large body of legal provisions that regulates the authority and line of command in case of emergencies with potential public health impact. 4.4.1 Civil protection The implementation of policy and plans is mainly achieved through the Civil Protection and Emergency Situations Services, which come under the authority of the Ministry of Interior, and are regulated mainly by the following legislation: Law No 271 on Civil Protection of 9 November 1994: establishes the fundamental principles of civil protection and the legal framework according to which all public authorities, enterprises, institutions, organizations, and citizens are required to act. Decision No. 347 of 25 March 2003: includes a definition and classification of the different types (e.g. natural, technological, biological-social) and levels (local, territorial, national, trans boundary) of an emergency. The Decision also includes the provisions for collecting and exchanging information on prevention and response. Decision No. 961 of 21 August 2006: establishes a national laboratory network for the surveillance and control of radioactive, poisonous and highly toxic substances, and biologic agents in the environment. Law No. 93 on Civil Protection and Emergency Situations Service of 5 April 2007: establishes the Civil Protection and Emergency Situations Services, defines its roles and responsibilities at national and sub-national levels, as well as the conditions of service. The Civil Protection and Emergency Situations Services are responsible for coordinating the activities of all authorities involved in response to disasters, including the health authorities. 4.4.2 Health services In the health sector, crisis preparedness, mitigation and response is covered by three overarching laws: 49 50 Law No. 411 of 28 March 1995, which establishes the fundamental requirements for providing health care to the population, also in crisis situations (Article 24), aimed at strengthening crisis preparedness and response in the health sector. Law No. 10-XVI of 3 February 2009 which defines responsibilities of PHS on surveillance and control of communicable diseases and public health events, including investigation of outbreaks of infectious diseases. A dedicated chapter (IX) relates to approach, responsibilities and management of public health emergencies. In the context of the International Health Regulations (2005 50), the law sets out special “empowerment” clauses Government Decision No. 1032 of 20.12.2013) WHO, 2005 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 55 of 95 concerning persons and goods, for specific actions that can be required to be taken during public health emergencies (articles 60 and 61). Government Decision No. 1076/2010 provides definitions, classifications and evaluation criteria for emergency situations, as well as methodology for data collection and information flow The Ministry of Health unified plan for emergency situations takes into consideration country-specific risks and sets out the basic measures to be followed, including health care for the population facing certain threats and triggers; for example, situations such as earthquakes, outbreaks of communicable disease, epidemics, radioactive contamination, transport accidents, and accidents and incidents caused by chemical agents. This plan is published the Ministry of Health website. Rayon/ municipal and institutional plans for prevention, preparedness and management of public health emergencies are annually adjusted and approved. At operational level some specific plans exist for preparedness and response to certain public health events (i.e. avian/pandemic influenza, cholera and outbreaks of acute diarrhoeal diseases). 4.5 Strategic and Coordinating Bodies Health emergency planning and response involves organisations at governmental, Ministry and local levels (see Annex 5) 4.5.1 Governmental level (a) Government Commission for Emergency Situations The Commission is the main body responsible for implementing preventive measures, verifying emergency preparedness and managing emergency situations, generated by all hazards. The Commission is chaired by the Prime Minister and includes representatives from all ministries and departments. The Commission has executive functions for prevention and response in all-hazard emergencies. (b) Civil Protection and Exceptional Situations Service (CPESS) CPESS is a national multi-sectorial agency and working body of the Government Commission for Emergency Situations, under the authority of the Ministry for Internal Affairs, and acting as the secretariat (implementing body) of the Government Commission. It is responsible for development of the National Multi-sectoral Plan for Civil Protection that includes components from the sector plans of the ministries and government agencies. (c) National Extraordinary Commission for Public Health The Commission is responsible for an integrated approach on prevention and management measures, multi-sectorial mobilization and coordination of response to public health threats and emergencies. It ensures an adequate degree of preparedness for public health emergencies and their management. 4.5.2 Coordinating bodies subordinated to the Ministry of Health (a) MoH Commission for Emergency Situations The Commission is responsible for ensuring an adequate degree of the Health System preparedness for public health emergencies, as well as providing management of measures on prevention, mitigation, response and recovery in case of their occurrence. (b) National Centre of Public Health (NCPH) NCPH is the scientific, technical and coordinating institution of the MoH Service of State Surveillance, and the Implementing body of the National Extraordinary Public Health Commission (see chapter 1). NCPH functions include emergency preparedness and interventions in public health emergencies, in collaboration with the relevant services of other ministries and central authorities. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 56 of 95 Figure 5 - Public health emergencies organisational structure, Republic of Moldova Source: Moldova Ministry of Health In case of emergency situations such as outbreaks, the NCPH (and CPH at rayon/municipal levels), carry out antiepidemic and sanitary-hygienic measures (c) National Scientific and Practical Centre of Emergency Medicine (NSPCEM) Tertiary level medical institution, providing emergency medical care, including for mass casualty situations. NSPCEM is a coordinating body of the Medical Emergency Service and Disaster Medicine Service. (d) Centre for Disaster Medicine (RCDM) RCDM is a specialized subdivision within NSPCEM, responsible for planning and coordinating the work of all components of the Disaster Medicine Service. 4.5.3 Rayon/municipal level At local level, emergency pre-hospital care is provided by a system comprising the Emergency Medical Assistance Service (EMAS), and Emergency Medicine Zonal Stations, supported by Medical units, Paramedical and medical teams, , and Civil Protection first aid teams, drawn for different organisations (see Annex 4.1).Hospitals provide emergency inpatient and out-patient care, as well as specialized medical teams. As above the Centres for Public health carry out local epidemic control and hygiene measures in disease outbreak situations, supported as needed by teams from NCPH (see section 2.5). 4.6 Early warning and communications All major emergencies are reported to the Civil Protection and Emergency Situations Services and the governor of the respective district. Communication channels are maintained via the telephone (including mobile telephones) and the Internet, and there are separate communication lines with the Civil Protection and Emergency Situations Services, the Hydro- meteorological services (Hydromet) and the police. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 57 of 95 The warning and communication system is based on the Emergency Medical Assistance Service despatch services and transmission networks, through which information regarding the emergency is sent and medical care activities for the population are conducted and coordinated. To achieve this task in all EMAS substations, special points for the reception and distribution of urgent information have been established by Minister of Health order51. The Operative Service of the Ministry of Health for 24 hour communication is located in the Ministry, but is part of the Disaster Management Centre, under the authority of the National Emergency Medicine Centre (NCPH). It is responsible for taking telephone calls on a 24-hour basis from a variety of sources, through the public number (721010). The main role of the Operative Service is two-fold: (1) to deal with general enquiries from the public on health-related issues and problems in accessing health services (but not calls for emergency ambulance services; these are directed through the 903 number); and (2) to act as focal point for the communication of important information between the Ministry of Health and other ministries, subordinate institutions, hospitals and district authorities, on request. The staff of the Operative Service has no service provision authority: in the event of a serious event, it is responsible only for ensuring that information reaches the relevant people within in the Ministry of Health, functioning basically as the Ministry's hot line. The Service is well organized and has well-documented standard operating procedures, with lists of contact numbers for hospitals and key personnel and a system of logging calls and action taken. In accordance with IHR requirements that call upon countries to strengthen their capacities on early detection, assessment and communication on public health threats, a unit monitoring public health threats at regional, national and international level was created in 2009 in the NCPH. 4.7 Training The Epidemiology Department of the State University of Medicine and Pharmacy “Nicolae Testemitanu” provides a small training program on public health emergencies management, risk management and risk communication. The training curricula on Public health emergencies preparedness and response is underdeveloped. The Faculty of Post Graduate Medicine offers a number of obligatory short courses and postgraduate training in public health, including a module on climate change and health. However, training in disaster management is not available. Training in emergency medicine is provided in medical colleges and training centres, and there is now a medical specialty training programme in emergency medicine. 4.8 Summary In summary the Moldova health emergency preparedness system has a number of strengths: 51 The Civil Protection and Emergency Situation Service maintains a national, multi-sectorial plan for the protection of citizens. It includes components of all plans prepared by the various ministries and government agencies, including the health sector. The intersectorial Extraordinary Committee on Public Health (national and rayon level) ensures an integrated approach, applying prevention and management measures, multi-sectoral mobilisation and coordination response in public health threats and emergencies. A national multi-hazard sector plan is available which appears to cover the main components necessary to initiate a crisis response, with components of mass casualty and health care management. Similar generic plans exist for each district and detailed plans specific to avian influenza and influenza pandemic have also been developed. National multi-sectoral and sectoral/district-level plans are in place to manage emergency situations, and committees are appointed at all jurisdictions to coordinate activities. Rapid response teams at all health system levels are designated and trained in first response to disasters. The communicable disease surveillance system is well equipped to monitor occurrence of infectious diseases and identify unusual and unexpected health events clustering by place, time and population groups, allowing early detection, risk assessment and response actions. For management of public health events caused by biological and radiological agents, specific intervention plans and operation procedures are developed and approved. IHR (2005) is in the process of being implemented, and the National Focal Point for IHR is the contact for national and international partners during an emergency of international concern. MoH order nr.382 from 11.08.2009. Page 58 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 PUBLIC HEALTH EMERGENCY PREPAREDNESS: STRENGTHS AND WEAKNESSES COMPONENT P1: REGULATORY AND STRATEGIC BASIS Strengths Regulatory framework The preparedness for, response to, and recovery from public health emergencies is a shared responsibility at government level, between civil protection and public health. Legal basis exists that regulates the authority and line of command in case of emergencies with potential public health impact. Well maintained cross sector plans The Civil Protection and Emergency Situation Service maintains and regularly updates a national, multi-sectorial plan for disaster risk reduction. It includes components of all plans prepared by the various ministries and government agencies, including the health sector. Problem Recommendation P1.1 Complex legislative framework The existing legal framework applicable to public health preparedness and response system is diluted in multiple primary and secondary legal acts. Operational responsibilities and associated regulations are similarly reflected in numerous provisions and guidelines which make it difficult (at field level) to clearly understand the links and chain of command. The Ministry of Health Commission for Emergency Situations, in collaboration with the Civil Protection and Emergency Situation Service should develop a simple, integrated strategic framework (and roadmap) to identify shortcomings and to align the national legislation to the requirements of the EU Decision 1082/2013, especially as it concerns the national allhazard plans for cross-border threat to health. P1.2 Alignment to EU acquis The legal framework in the area of public health emergency preparedness and response is not fully adjusted to the provisions of EU acquis (eg. Decision 1082/2013). Coordination of key activities among the authorities concerned is not regulated by clear terms of reference (e.g. sharing of data on food-borne outbreaks). Standard operating procedures for intervention on specific hazards and emergencies, as well as business continuity plans for essential services within the health sector (though appears that some hospital maintain an emergency plan for acute crises) are not in place. There is a need (MoH) to develop a public health strategic preparedness plan, defining requirements (upsurge capacity) and responsibilities of all services, and a detailed plan of specific and cross-sectorial simulation exercises aimed at testing operational procedures and training of emergency personnel. Priority sectors should be identified with which joint SOPs and TORs need to be developed, tested and enforced. Page 59 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT P2: EMERGENCY PREPAREDNESS AND RESPONSE ORGANISATION Strengths Traditional organisational frameworks A well-structured organisation, at all level of the government and territorial jurisdictions, based on a framework inherited from previous administrations. Response plans and structures in place at all levels National multi-sectorial and district-level plans for disaster risk reduction are in place to manage emergency situations, and committees are appointed to coordinate activities. Rapid response teams at all levels of the health system are designated and trained. National level expert and cross sector planning The Commission for Exceptional Situations, represented by different ministries and departments, is responsible for planning and management in all crises situations, including epidemics. The Civil Protection is the national authority responsible for implementing policies in the area of crisis situations and the National Multi-sectorial Plan for Civil Protection includes components from the sector plans of the ministries and governmental agencies. Hospital and local health emergency planning The Ministry of Health develops guidelines on preparedness planning to hospitals and district authorities. Plans developed by the district are approved in coordination with the Disaster Medicine Centre. Problem Recommendation P2.1 Dispersed and overlapping responsibilities The organisational structure at national and local level has developed over recent years by the way of adding entities with overlapping responsibilities. The dispersed capacities to identify, assess, and manage public health risks and emergencies, as well as the insufficient cross-sector collaboration at the local and national levels, are of concern for clarity of the line of command from central to local level, in planning and responding to public health emergencies. Clear responsibilities, and necessary resources, should be assigned to the NCPH for: Public health risk assessment; Developing an integrated PH emergency plan, with guidelines and operating procedures; Developing and maintaining exercise and training programmes for targeted PH personnel for preparedness and response to PH emergencies of both short and long duration (outbreaks and pandemics). P2.2 Biosafety and biosecurity There is no specific strategic framework in the area of biosafety and biosecurity addressing laboratory capacity for identifying, assessing, monitoring, and minimizing health risks of biologic origin, including assessing events due to deliberate release of agents (bioterrorism). The institutional framework for preparedness and response should clearly identify links and responsibilities between relevant authorities (across sectors such as public health laboratories and law enforcement) and develop specific guidelines and terms of reference addressing biosafety and response to deliberate release of agents. Page 60 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT P3: EMERGENCY PREPAREDNESS PLANNING Strengths Maintained and updated cross-sector planning The CPESS is responsible for preparing and regularly updating a national, multi-sectorial plan for the protection of citizens, including components of all plans prepared by the various ministries and government agencies, including the health sector. A national multi-hazard preparedness plan (under the strategic coordination of Civil Protection) is available covering the main components necessary to initiate a crisis response. Similar generic plans exist for each district and detailed plans for specific health threats (avian influenza and influenza pandemic) were developed. Pandemic preparedness planning The current national Pandemic Influenza preparedness plan was published in December 2009. MoH intended to update the plan in 2013, addressing all potential pandemic strains not just H1N1. Communication plans The MoH has a "General Communication Plan in Public Health" which includes a communication plan for the public covering communication for all extraordinary health events including pandemic influenza. Communication material was produced and tested during the 2009 H1N1 pandemic, based on WHO guidelines and translated into Moldovan and Russian. Posters were also distributed at the airport. Problem Recommendation P3.1 Public health emergency planning Health sector preparedness planning focuses mainly on emergency care services and the emergency response phase. The disaster management plan seems not to be geared to respond to crisis of long duration such as pandemic flu. There is a need (MoH) to develop a public health strategic plan, defining requirements (upsurge capacity) and responsibilities of all services, and a detailed plan of specific and cross-sectorial simulation exercises aimed at testing operational procedures and training of emergency personnel. The strategic plan should give considerations to a multi-hazard approach, defining common managerial responsibilities concerning dissemination of information, crisis coordination and definition of roles. Risk assessment is not formally and systematically performed for emergencies in the public sector involving communicable diseases, using modern methods of risk ranking, to identify vulnerability in the PH sector and to define the necessary flexibility, efficiency and resource to respond to PH emergencies A systematic risk profile on communicable diseases (vulnerability, impact) should be developed using risk ranking methodology (cf. ECDC project proposal) as a basis to inform PH emergency planning for priority events. A working group could be appointed under the authority of the NCPH to perform this task in a timely manner and develop a review programme to regularly update the ranking (re. P3.2 for operational plans). P3.2 Operational response planning for health emergencies Specific preparedness and response (operational) plans are lacking (or outdated) for major public health emergencies, including templates and guidelines for assessment of risks, needs, and vulnerabilities planning, testing, response, risk/crisis communication (including for deliberate release of biologic agents). The all-hazard generic plan should be accompanied by more detailed specific plans, based on a robust risk assessment (impacts and vulnerabilities), each with guidelines on hazard-specific issues, such as: Distancing measures for populations and rationale for access to services; Preparedness for mass gathering management; Page 61 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Communicable diseases with epidemic potential (e.g. dengue, cholera, avian influenza or influenza pandemic) and zoonoses; consideration to be given to prolonged crises. Incidents due to deliberate release (biological, chemical, radio-nuclear). Other specific major hazards (environmental, technological and social) to which the country is vulnerable. P3.3 Pandemic influenza planning An updated national Pandemic Influenza Preparedness plan (post 2009 pandemic) has not been completed. not finalized. A new national preparedness plan for Pandemic Influenza addressing issues identified during H1N1 2009 pandemic should be developed with reference to the new WHO guidelines on pandemic influenza (2013). Page 62 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT P4: PREPAREDNESS AND RESPONSE OPERATIONS Strengths Clarity of operational response planning The civil protection service has developed a classification of emergency situations based on resources needed for first response. The multi-sectorial organisation of the strategic level is reflected at the operational level in response to an emergency, where the responsibility for coordinating health-related support in a crisis situation is shared between the Ministry of Health and their Commission for Emergency Situations, the State Agency for Material Reserves, Public Acquisitions and Humanitarian Aid, the Government’s Interdepartmental Commission for Humanitarian Aid and possible other central, regional and local authorities. Specific response plans for major public health events For management of major public health events caused by biological and radiological agents, specific intervention plans and operating procedures are developed and enforced. Cross border agreements A cross-border agreement (with Romania and Ukraine) exists for deployment of response capacities in case of major emergencies. This includes provisions for earthquakes and floods. Moldova has sufficient emergency medical services (rapid response teams) nationwide. Outbreak detection and response The communicable disease surveillance system is able to detect unusual and unexpected health events, allowing early detection, risk assessment and rapid response. Local staff carries out investigations of outbreaks, and national staff are often involved in support to local epidemiologists for events of major importance. Problem Recommendation P4.1 Clarity of operational responsibility in public health emergencies The dispersed capacities to identify, assess, and manage public health risks and emergencies, as well as the insufficient cross-sector collaboration at the local and national levels, make difficult the effective coordination of response to minimise the impact of public health emergencies It would be useful to clearly define the lines of command and control in public health emergencies, preferably having the Ministry of Health and their crisis coordinator as the highest authority. The NCPH could be delegated by the MoH to develop an operational preparedness and response plan, based on the national all-hazard strategic plan. Local public authorities, could be involved in developing generic and specific plans (including training and exercising) beginning from regional and municipal risk assessment P4.2 Public health emergency training There are limited trained human resources in the primary healthcare and public health systems, to be able to assess the public health risks, to plan and evaluate, as well as to report data to the surveillance system. An inventory of essential resources and trained personnel should be developed and maintained, including the acquisition of modern equipment for rapid identification and confirmation of threats (mobile labs and rapid intervention teams) At the national level refresher training is provided regularly for epidemiologists involved in response teams, but at the sub-national level Moldova lacks the finances for this regular training. Training programmes need to include not only emergency medicine and mass casualty management but also a broad range of topics related to disaster management and public health. A programme of regular training of the intervention TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 63 of 95 teams should be developed on planning, preparing, estimating the needs and vulnerabilities, evaluating, managing and communicating the risks, and postintervention evaluation. P4.3 Rapid response teams Rapid response teams appear to lack equipment (i.e. transport, mobile labs) and training in public health emergencies (planning, risk assessment, risk management and crisis communication) in line with international standards and best practice. A long-term, cost-effective business plan should be developed for modernising mobile and PPE equipment, and submitted to relevant authorities (including donor community) for project funding. Page 64 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 COMPONENT P5: MONITORING AND EVALUATION Strengths Exercising and monitoring of plans at national and rayon level The Civil protection and Emergency Situations service (CPESS) is responsible for conducting multi-sectorial simulation exercises in six or seven districts a year, and for reporting on the status of the health sector to the Prime Minister. The Disaster Medicine Centre has been delegated by the Ministry of Health to be responsible for monitoring and evaluation in the health sector and takes an active role in this process. The generic, all-hazard health sector plans at the rayon/municipal level, which are based on a national template, are reviewed and coordinated by the Disaster Medicine Centre on a yearly basis and approved by the governor of the rayon. Problem Recommendation P5.1 Preparedness of local public health sector Apart from that which is implemented in cooperation with the Civil Protection and Emergency Situations Service, the Public Health sector does not have a strategy for monitoring and testing the effectiveness of Rayon health sector plans or the crisis plans of individual medical services (laboratories, epidemiology services, PHC). L5.2 Rayon level public health preparedness plans Insufficient human resources in the rayon and municipal Centres of Public Health to provide complete and prompt reporting on events with public health impact and monitor the effectiveness of local plans. L5.3 Links with EU institutions relating to public health emergencies Although international collaboration exists in civil protection (including links with EU MIC), and the system has been tested with international inputs, the links with EU are still to be established, especially in consideration to the monitoring and evaluation of public health capacities and capabilities to respond to crossborder health threats. The preparedness and response plan should contain a programme of simulation exercises for different scenarios at national and rayon/municipal levels, including in individual medical facilities, for example dealing with an unidentified infectious disease with a high mortality rate. The simulation exercises should be extended to involve the national reference laboratories (see recommendation L4.3). The exercises should aim at identifying gaps and procedures to be addressed by revision of respective plans and establishment of specific training curricula for personnel. Lessons learned from the pandemic influenza response (2009) could be used as case study to identify gaps of an all-hazard public health preparedness plan, and to build upon. Strengthening operational links with the European Centre for Disease Prevention and Control and participating actively in relevant disease-specific networks and training and evaluation projects (including international simulation exercises, and system assessments in other countries) would provide opportunities to review and improve some of the gaps and give access to EU financial mechanisms. TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Annexes 1 International and National Review Teams, and National Respondents 2 Terms of Reference 3 Legislation, Decisions, Orders relating to Communicable Disease Prevention and Control 4 List of reportable diseases, syndromes, events. 5 Organisational Responders: Public Health Emergencies Page 65 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 66 of 95 Annex 1. International and National Review Teams, and National Respondents International team: Massimo Ciotti, senior expert, public health emergency preparedness, , ECDC (international team leader) Ivana Bozicevic, epidemiologist, WHO Collaborating Centre, Zagreb. Graham Fraser, epidemiologist, ECDC. Katrin Leitmeyer, public health microbiologist, ECDC. Florin Popovici, medical chief, Romania National Institute of Public Health, Bucharest. Nabil Safrany, international liaison support, ECDC (Stockholm). National team: Stela Gheorghita, epidemiologist, NCPH, Chisinau (national team leader). Ion Apostol, specialist, NCPH, Chisinau. Natalia Caterinciuc, epidemiologist, Center for diarrheic and zoonotic diseases, NCPH, Chisinau. Valeriu Chicu, associate professor, State University of Medicine and Pharmacy, Chisinau. Radu Cojocaru, public health microbiologist, NCPH, Chisinau. Anatolie Melnic, epidemiologist, Center for Vaccine Preventable diseases, NCPH, Chisinau. Constantine Rimis, public health microbiologist, NCPH, Chisinau. Principal System Respondents in Moldova: (a) National: Stela Gheorghita, epidemiologist, NCPH, Chisinau (national team leader). Valeriu Chicu, associate professor, State University of Medicine and Pharmacy, Chisinau. Anatolie Melnic, epidemiologist, Center for Vaccine Preventable diseases, NCPH, Chisinau. Radu Cojocaru, public health microbiologist, NCPH, Chisinau. Natalia Caterinciuc, epidemiologist, Center for diarrheic and zoonotic diseases, NCPH, Chisinau. Constantine Rimis, public health microbiologist, NCPH, Chisinau. Ion Apostol, specialist, NCPH, Chisinau. (b) Rayon and municipalities: Luminita Suveica, manager, Center of Public Health, mun. Chisinau. Nicolai Furtuna, epidemiologist, Center of Public Health mun. Chisinau. Liliana Domenti – manager, Institute of Phthysiopneumology, Chisinau. Lucia Pirtina, coordinator of HIV/AIDS program, Dermatovenerology and communicable diseases hospital, Chisinau. Vorel Bradu, head of the Center of Public Health Ungheni. Vladimir Lisenco, head of the Center of Public Health Cahul. Page 67 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Annex 2. Terms of Reference and Itinerary Expert Mission on Assessment of National Surveillance System for Communicable Diseases INT MARKT IND/EXP 54525 organised in co-operation with ECDC Venue: 30.03.2014 Chisinau, Republic of Moldova 31 March - 04 April 2014 For more information on TAIEX assistance and to download presentations of this event, please go to : http://ec.europa.eu/enlargement/taiex. Aim of the Expert Mission: Assessment of National Surveillance System for Communicable Diseases The objectives of the Assessment of National Surveillance System for Communicable Diseases include: 1. Assessment of Communicable Diseases national surveillance system components (structure, process, capacities, effectiveness, coordination) to evaluate the compliance with EU disease networks; 2. Assessment of the status of preparedness planning to respond to emergencies with particular reference to intra and intersectoral collaboration with sectors essential for the functioning of the public health sector; 3. Draw the proposal/plan of action on base of standard tools (strengths, weaknesses, opportunities, threats) for setting priorities, planning, integration of parallel surveillance system and the preparedness activities, mobilizing and distribution of available resources. Page 68 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Expert Mission Agenda Day 1: Monday 31 March 2014 Time 09:0010.00 Activity Briefing at the National Center of Public Health, MoH 10.1511.15 Briefing of the mission Presentation on the purpose questionnaire, procedure expectation from the evaluation Ministry of Health 11.3512.35 Visit to the European Union Delegation to the Republic of Moldova EU Delegation to the Republic of Moldova Address: 12, Kogălniceanu str., Chișinau, Tel : 22 505210 12.3513.30 Lunch 13.3017.00 Workshop with national experts. - Preparation activities for evaluation, - Selection of territories for evaluation, - Procedure and Data Collection Tools, - Field Testing of Questionnaire - Exercises on Field Assessment Facility / Venue National Center of Public Health National Center of Public Health Participants Experts Mihail Pisla; NCPH Ion Bahnarel, NCPH Stela Gheorghita, NCPH Anatolie Melnic, NCPH Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Experts Svetlana Cotelea, deputy minister MoH Carolina Cerniciuc, MoH Eugenia Berzan, MoH Mihail Pisla; NCPH Stela Gheorghița, NCPH Experts EU Delegation representatives Mihail Pisla; NCPH Stela Gheorghița, NCPH Experts Mihail Pisla; NCPH Stela Gheorghita, NCPH Anatolie Melnic, NCPH Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Valeriu Chicu, Nicolae Testemitsanu State University of Medicine and Pharmacy (SUMF) Ghenadie Curochin, Nicolae Testemitsanu State University of Medicine and Pharmacy Ludmila Birca, mun. hospital of contagious diseases in children Constantin Rimis, NCPH Nicolae Furtuna, Center of Public Health mun. Chisinau Nicolae Gaisan, Center of Public Health Cahul Veaceslav Cislari, Center of Public Health mun. Balti Viorel Bradu, Center of Public Health Ungheni Vasile Bejenaru, Center of Public Health Edinet Veronica Lefter, Center of Public Health Calarași Anatolie Talmazan, Center of Public Health Causeni Page 69 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Expert Mission Agenda Day 2 : Tuesday 01 April 2014 Time 07.00 Activity Departure to the districts Facility / Venue National Center of Public Health 10:0013.00 Visits to districts/rayons: 2 groups working in parallel: I group - Ungheni II group - Cahul : Center of Public Health Ungheni Center of Public Health Cahul Interested authorities 13.0013.30 13.3017.00 19.30 Each group will be split in 2 small subgroups (one international expert and one national expert): I subgroup: - primary health service - hospital (infectologist, pulmonologist, dermatovenerealogist etc) II subgroup: - veterinary and food safety service - rayon level civil emergency coordinator Lunch Field visit in selected territories: territorial CPH Both subgroups - laboratory - public health service (epidemiologist and staff; sanitary inspector) - other relevant services Arrival in Chisinau Center of Public Health Ungheni Center of Public Health Cahul Participants Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Valeriu Chicu, SUMF Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Valeriu Chicu, SUMF Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Vorel Bradu, Center of Public Health Ungheni Vladimir Lisenco, Center of Public Health Cahul Specialists from the Center of Public Health Ungheni and Cahul Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Valeriu Chicu, SUMF Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Vorel Bradu, Center of Public Health Ungheni Vladimir Lisenco, Center of Public Health Cahul Specialists from the Center of Public Health Ungheni and Cahul Page 70 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Expert Mission Agenda Day 3 : Wednesday 02 April 2014 Time 08.00 Activity Coordination meeting Facility / Venue National Center of Public Health 10:0013.00 Visits to intermediar and national level services/leaders mun. Chisinau: 2 groups working in parallel: I group will work with national level and will be split in 2 subgroups: health and non-health sectors I subgroup National CD surveillance and control leader and team (NCPH) National reference lab National programme leaders: TB, HIV, STI National leader CD emergency (MoH) II subgroup National civil emergency programme leaders (Ministry of Interior) Others II group will be split in 2 subgroups (one international expert and one national expert) to visit: I subgroup - primary health services (municipal and rural area) - hospital II subgroup - laboratory - public health service (epidemiologist and staff; sanitary inspector) - other special relevant services Lunch National Center of Public Health Center of Public Health Chisinau, Interested authorities Visits to intermediar and national level National Center of Public Health 13.0013.30 13.30- Participants Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Valeriu Chicu, SUMF Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Valeriu Chicu, SUMF Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Luminita Suveica, Center of Public Health Chisinau, Specialists from the Center of Public Health mun. Chisinau Liliana Domenti – Institut of Pneumology; Lucia Pirtina, coordinator of HIV/AIDS program , etc Experts Stela Gheorghita, NCPH Page 71 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 17.00 services/leaders mun. Chisinau Center of Public Health mun. Chisinau Interested authorities Anatolie Melnic, NCPH Valeriu Chicu, SUMF Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Luminita Suveica, Center of Public Health mun. Chisinau, Specialists from the Center of Public Health mun. Chisinau Liliana Domenti – Institute of Pneumology; Lucia Pirtina, coordinator of HIV/AIDS program , etc Expert Mission Agenda Day 4 : Thursday 03 April 2014 Time 09:0013.00 Activity Preliminary conclusions and additional visits to intermediar and national level health and non-health services, mun. Chisinau Facility / Venue National Center of Public Health Center of Public Health mun. Chisinau Interested authorities 13.0013.30 13.3017.00 Participants Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Valeriu Chicu, Nicolae Testemitsanu State University of Medicine and Pharmacy Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Nicolai Furtuna, Center of Public Health mun. Chisinau Specialists from the Center of Public Health mun. Chisinau, etc. Lunch Feedback workshop with national experts National Center of Public Health Experts Mihail Pisla, NCPH, Ion Bahnarel, NCPH Stela Gheorghita, NCPH Anatolie Melnic, NCPH Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Valeriu Chicu, Nicolae Testemitsanu State University of Medicine and Pharmacy Ghenadie Curochin, Nicolae Testemitsanu State University of Medicine and Pharmacy Ludmila Birca, mun. hospital of contagious diseases in children Constantin Rimis, NCPH Nicolae Furtuna, Center of Public Health mun. Chisinau Page 72 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Expert Mission Agenda Day 5 : Friday 04 April 2014 Time 09.0012.30 12.3013.30 13.3015.00 15.3017.00 Activity Preparation meeting for debriefing at the MoH Facility / Venue National Center of Public Health Participants Experts Stela Gheorghita, NCPH Anatolie Melnic, NCPH Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Valeriu Chicu, Nicolae Testemitsanu State University of Medicine and Pharmacy Ludmila Birca, mun. hospital of contagious diseases in children Constantin Rimis, NCPH Nicolae Furtuna, Center of Public Health mun. Chisinau Lunch Debriefing at the Ministry of Health Discussions, outcomes, collaboration perspectives Ministry of Health National Center of Public Health Experts Svetlana Cotelea, deputy minister MoH Carolina Cerniciuc, MoH Eugenia Berzan, MoH Mihail Pisla, NCPH Ion Bahnarel, NCPH Valeriu Chicu, Nicolae Testemitsanu State University of Medicine and Pharmacy Stela Gheorghița, NCPH Anatolie Melnic, NCPH Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Experts Mihail Pisla, NCPH Ion Bahnarel, NCPH Stela Gheorghita, NCPH Anatolie Melnic, NCPH Valeriu Chicu, Nicolae Testemitsanu State University of Medicine and Pharmacy Radu Cojocaru, NCPH Natalia Caterinciuc, NCPH Constantin Rimis, NCPH Nicolae Furtuna, Center of Public Health mun. Chisinau Page 73 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Annex 3. Principal Legislation, Decisions, Orders relating to Communicable Disease Prevention and Control in Republic of Moldova Nr. d/o Name Data of approving Nr. Published Laws 1. Law on State Surveillance of Public Health 03.02.2009 nr.10-XVI 2. Law on health service 28.03.1995 nr.411-XIII 3. Law on prophylaxis of HIV/AIDS 16.02.2007 nr. 23-XVI 4. 04.07.2008 Nr. 153 Law on control and prophylaxis of tuberculosis M.O.nr.67/183 din 03.04.2009 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 1169 M.O. nr. 34, art nr.373 din 22.06.1995 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=31 2823 M.O.nr. 54-56/250 din 20.04.07 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=32 3271 M.O.nr.143-144, art nr.583 din 05.08.2008 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=32 8770 Governmental Decree / Decision 5. Gov. Decision on approving law on health service 06.08.2007 Nr 886 6. Gov. Decision on approving Strategy of health system development for period 2008-2017 7. Gov. Decision related to State Surveillance of Public Health 24.12.2007 Nr. 1471 8. Gov. Decision related to the National Extraordinary Commission of Public Health 14.12.2009 Nr.820 9. Gov. Decision on approving Action Plan for IHR implementation in the Republic of Moldova 26.03.2008 Nr.475 10. Gov. Decision on approving Strategy on Public Health for period 2014-2020 20.12.2013 Nr.1032 12.05.2010 nr. 384 MO nr. 127-130/931 din 2007 http://lex.justice.md/md/324940/ M.O nr. 8-10, art nr. 43 din 15.01.2008 http://lex.justice.md/md/326615/ M.O., nr.78-80/455 din 21.05.2010 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 4620 MO nr 187-188 din 18.12.2009 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 3111 MO nr 16-17/88 din 26.01.2008 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=32 7526 M.O. nr. 304-310, art nr.1139 din 27.12.2013 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=35 0833 Page 74 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 11. Gov. Decision on approving of gradual sectoral framework for combating the effects of new pandemic influenza A (H1N1) in Republic of Moldova 15.12.2009 Nr.824 12. Gov. Decision on approving National Immunization Program for period 20112015 23.12.2010 Nr.1192 13. Gov. Decision on approving National Program on prevention and control of HIV/AIDS and STI for period 2011-2015 16.12.2010 nr.1143 14. Gov. Decision on approving National Program on combating viral hepatitis B, C and D for period 2012-2016 13.02.2012 Nr.90 15. Gov. Decision on approving National Program on control of tuberculosis for period 2011-2015 21.12.2010 16. Gov. Decision on approving Regulation related national surveillance and control of communicable diseases and public health events 25.11.2013 17. Gov. Decision related to the combating and prophylactic measures of rabies 06.05.1998 Nr.494 18. Gov. Decision on Sanitary Regulation on hygiene for health care institutions 23.07.2010 Nr.663 Nr.1171 Nr.951 M.O. nr. 191-192, art nr.927 din 25.12.2009 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 3177 M.O. nr. 259-263, art nr.1319 din 31.12.2010 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 7207 M.O. nr. 254-256, art nr.1286 din 24.12.2010 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 7100 M.O. nr. 34-37 din 17.02.2012, art Nr : 115 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=34 2219 M.O. nr. 259-263, art nr.1316 din 31.12.2010 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 7204 M.O. nr.284-289 (4602-4607) din 06.12.2013 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=35 0538 M.O. nr. 62-65/1998 din 09.07.1998 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=30 2497 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 5428 19. MoH order/decision 20. MoH order on State Surveillance of Public Health 21. MoH order on approving of case definition for diagnosis, recording and reporting of communicable diseases in the Republic of Moldova 22. MoH order regarding the implementation of the Programme for development of state surveillance public health Laboratory Network in RM 03.06.2010 12.10.2007 10.06.2013 nr.369 http://www.cnsp.md/info.php?id1= 34&id2=4&page=7 nr. 385 Nr.668 http://www.cnsp.md/down/info137 1468083ro.pdf Page 75 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 23. MoH decision available on commissioning experimental electronic surveillance system for communicable diseases 24. MoH on approving reporting form about detection of communicable disease, intoxication, toxi-infection caused by food and/or occupation site, adverse effect after vaccination 25. MoH order on the improvement of surveillance system for influenza and acute respiratory infections 26. MoH order on enhancing activities on combating viral hepatitis B,C and D in RM 31.07.2009 nr.477-d 11.01.2011 Nr.13 http://ms.gov.md/sites/default/files/ legislatie/ordinul_nr._13_din_11.01. 2011.pdf 31.10.2011 Nr.824 http://ms.gov.md/legislatie?field_le gtip_tid=16&=Caut%C4%83, MoH order 824 21.09.1998 nr. 264 27. MoH order regarding organization prevention and combating measures for cholera and other acute diarrheal diseases in RM 28. MoH order regarding epidemiological sentinel surveillance of communityacquired pneumonia in children under 5 years 29. MoH order regarding implementation of Gov. Decision nr. 475 from 26.03.2008 on approving Action Plan for IHR implementation in the Republic of Moldova 30. MoH order Related to prophylactic measures and combating viral hepatitis B in RM 03.06.2010 nr.371 http://ms.gov.md/sites/default/files/ legislatie/ordin_no_371_din_03.06.2 010.pdf 23.10.2013 Nr.1190 http://ms.gov.md/sites/default/files/ legislatie/ord._1190_din_23.10.3_su pravegherea_epidem._pneumonii_c omunitare.pdf 06.08. 2009 nr.268 14.07. 2004 nr. 211 31. MoH order on implementation of National Program on combating viral hepatitis B, C and D for period 20122016 32. MoH order on implementation of National Immunization Program for period 2011-2015 30.03.2011 Nr.301 http://ms.gov.md/sites/default/files/ legislatie/ordinul_nr._104_din_16.02 .2011.pdf 33. MoH order on implementation National Program on prevention and control of HIV/AIDS and STI for period 2011-2015 34. MoH order on the surveillance and http://ms.gov.md/sites/default/files/ legislatie/ordinul_nr._301_din_30.03 .2012.pdf http://ms.gov.md/sites/default/files/ legislatie/ordinul_nr._69_din_03.02. 2011.pdf 16.02.2009 nr.51 http://cnsp.md/down/info13893705 31ro.pdf 35. MoH order on approving forms for health care 31.10.2011 Nr.828 http://ms.gov.md/sites/default/files/ legislatie/ordinul_nr._828_din_31.10 .2011.pdf 36. MoH order on strategies to eliminate measles and rubella and surveillance of these infections 23.01.2006 nr. 37 control of nosocomial infections" that approved "Guidelines for the surveillance and control of nosocomial infections" Page 76 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 37. MoH order on changes of the "Instruction on conducting laboratory investigation to HIV/ AIDS in blood donor samples, people from high risk groups and other contingents of the population in diagnostic laboratories for AIDS, hepatitis and other viral infections" 38. MoH order about testing of blood donors for HIV / AIDS in blood transfusion centers in RM 02.04.2002 nr. 64 11.12.2003 nr. 354 39. Epidemiological surveillance on HIV/AIDA. Standard protocol. 19.01.2007 nr.20 40. MoH order on approving the regulation for examination and medical surveillance to detect contamination with human immunodeficiency virus (AIDS) 41. MoH order on the implementation of Gov. Decision nr.1075 from 16.11.2010. Joint Action Plan of the countries NIS on combating HIV/AIDS 42. MoH decision on carrying out surveillance of HIV/AIDS second generation 31.07.2007 nr. 314 27.12.2011 nr. 842 14.05.2009 nr. 300 43. MoH decision on optimizing the collection, transportation and release the results for blood samples for HIV testing. 44. MoH Order on the optimization of epidemiological surveillance and increase the effectiveness of measures to prevent and combating helmintiasis in RM" 45.MoH order on the Rules of examination and medical surveillance to detect contamination with human immunodeficiency virus (AIDS) 46. MoH and MoA order on surveillance, monitoring, prophylactic and combating of salmonellosis 15.07.2009 nr. 420 23.01.2006 nr. 36 http://cnsp.md/down/info13932365 76ro.pdf 08.08.2012 nr.790 M.O. nr.234-236/1329 din 09.11.12 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=34 5329 30.09.2004 nr.285 47. MoH order on improving of prophylactic measures on rabies 12.03.99 nr.74 48. MoH order on improving measures for diagnostic, prophylaxis and epidemiological surveillance of zooantroponosis 49. MoH order on prophylaxis and combating Bovine spongiform encephalopathy (Creutzfeldt-Jacob). 10.08.02 nr.218 28.11.01 nr.274 50. MoH order on improving the control and prevention of yersiniosis 21.05.97 nr.108 Page 77 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 51. MoH on epidemiological surveillance of typhus, the control and prevention of pediculosis 21.02.2013 Nr.164 http://ms.gov.md/sites/default/files/ legislatie/ord_164_din_21.02.2013.p df 52. MoH order on achievement Gov.Decision nr. 663 of 23.07.2010 approving the Regulation on the hygiene health medical institutions 14.09.2010 Nr.632 http://www.ms.gov.md/sites/default /files/legislatie/ordin_no_632_din_1 4.09.2010.pdf 53.MoH order on implementation of measures for prevention morbidity of diphtheria 18.09.1986 nr. 380 54.MoH order on improving measures for enhancing activities in prophylaxis meningococcal infection and implementation of epidemiological surveillance 55.MoH order for unification bacteriological investigations used in clinical-diagnostic laboratories 01.12.1988 nr.858 22.04.1985 nr.535 56. MoH decision on improving activities of bacteriological laboratories of CPH 30.12.1997 nr.314 57. MoH decision on implementation of measures for minimizing of effect of bioterrorist act in the Republic of Moldova 58. MoH decision on implementing biosecurity measures 14.04.2003 nr.105-d 15.04.03 nr.108-d Guideline 59.“National guidelines and Operational Manual on second generation epidemiological surveillance on HIV/AIDS in Republic of Moldova” 60.National guidelines and quality management in laboratory investigation on HIV/AIDS in RM 61. Toxocarosis 26.12.2013 MoH ord. nr. 1551 19.01.2007 Ord. MS nr. 20 62.Standard on epidemiological surveillance on HIV/AIDS 25.11.2013 63. 16.02.2009 Guidelines for the surveillance and control of nosocomial infections 09.09.13 64. Ghidelines. Intestinal dismicrobism in children. 16.05.01 65.Criptosporidasis: ethiopathogenesis, clinical manifestation, laboratory diagnostics, epidemiology, combating 28.02.2005 Ghide, aproved by MoH order nr. 0114/16-91 Nr. 951 http://cnsp.md/down/info13830389 25ro.pdf Approved by MoH order nr. 51 http://www.cnsp.md/down/info138 9370531ro.pdf Nr.12 RM nr. 01.10.32.23 Page 78 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 and prevention measures 66.Etiology, epidemiology, pathogenicity, clinical manifestation, laboratory diagnostics, treatment, combating and prevention measures strongiloidosis. 67.Echinococcoses (hidatidozis): etiology, pathogenicity, clinical manifestation, laboratory diagnostics, treatment, epidemiology and prophylactic measures 68.Methods for sanitary – parasitology investigation in environment objects 28.02.2005 RM nr. 01.10.32.24 15.05. 2012 IM nr.3 20.07. 2011 ord. MS nr.585 69. Guidance on laboratory biosafety, (WHO Laboratory biosafety manual, 3th edition) 2011 http://cnsp.md/down/info13103692 88ro.pdf 70. Guidance on regulations for the Transport of Infectious Substances 2011 http://cnsp.md/down/info13103694 63ro.pdf Indications, recommendations 71. Methodical indications. Epidemiology of salmonellosis in humans and animals, prevention and control measures 23.12.2005 Nr.08c1/2573 72. Recommendation. Rotavirus infection in children - etiology, epidemiology, clinical diagnosis, treatment, prevention 24.10.2013 73. Recommendation. Supplementary measures on prophylaxis and combating diarrheic diseases in children. 74. Methodical indications. Epidemiology, diagnosis and prophylaxis of Lyme borreliosis 28.02.2005 Nr.01.10.3 2.2-2 23.03.2006 08a-1/557 75. Methodical indications. Microbiologic diagnostics of diarrheic diseases 24.08.2012 Nr.7 76. Methodical indications. Determination of bacterial sensitivity to antimicrobial preparations by diffusion method. 24.08.2012 Nr.8 77. Indications. Epidemiology, clinical manifestation, and epidemiological surveillance for tularemia 14.01.97 Nr.7-d 78. Indications. Epidemiology, clinical manifestation, and epidemiological surveillance for leptospirosis 14.01.97 Nr.8-d 79. Indications. Epidemiology, clinical manifestation, and lab.diagnostic, 16.06.1999 06.3.9.27 Page 79 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 epidemiological surveillance for anthrax 80. Indications. Epidemiology, clinical manifestation, lab.diagnostic, epidemiological surveillance and prophylaxis for Q fever 22.12.1999 Nr.06.3.9.3 1 81. Indications. Epidemiology, clinical manifestation, and epidemiological surveillance for brucelosis 17.12.2001 Nr.06.9.3.4 7 82. Indications. Clinical manifestation, and epidemiological surveillance for spongiform encephalopathy 07.03.2003 Nr.06.9.3.4 8 83. Indications. Microbiologic diagnostic of campilobacteriosis 22.06.2006 84. Indications. Collecting, evidence and prognosis of number of small micromammals 12.10.2012 Nr.9 Food safety 85. Law regarding food 18.03.2004 nr. 78 86. Gov. Decision on approving Regulation regarding microbiological criteria for food 16.03.09 nr.221 08.11.07 (anex nr.4) nr.120 9 88. Government Decision approving sanitary regulations on food supplements 02.09.09 nr.538 89. Government Decision on approving Sanitary Regulations on new food products 31.12.09 nr.925 90. Government Decision on approving Sanitary Regulations for contaminants in food 22.06.10 nr.520 91. Government Decision on approving of General Regulations on food hygiene 25.05.10 Nr.412 87. Gov. Decision on catering services M.O., nr.83-87/431 din 28.05.2004 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=31 3238 M.O. nr.59-61/272 din 24.03.09 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 1096 M.O., nr.180-183/1281 din 23.11.07 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=32 5940 M.O, nr.138-139/603 din 08.09.2009 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 2200 M.O., nr.2-4/16 din 15.01.2010 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 3395 M.O., nr.108-109/607 din 29.06.2010 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 5039 M.O., nr.83-84 din 28.05.10 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 4708 Page 80 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 92. Government Decision on approving Sanitary Regulations on infant formulas and formulas of preparations for infants and toddlers 93. Government Decision on approving Sanitary Regulations on food additives 11.05.11 Nr.338 29.03.13 nr.229 M.O., nr.82 din 17.05.11 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=33 8552 M.O. nr.69-74 din 05.04.13 http://lex.justice.md/index.php?acti on=view&view=doc&lang=1&id=34 7280 Page 81 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Annex 4. List of reportable diseases, syndromes, events. Infectious diseases and special health events reportable in the Republic of Moldova (with indication of diseases and health events reportable to EU level) Anexa nr. 1 la ordinul MS nr. 385 din 12.10.2007 Denumirea Boli aflate în supraveghere în UE* 2 3 Nr.d/r 1 I. Boli transmisibile 1. Amibiaza 2. Antraxul 3. Ascaridioza 4. Boala (infecţia) meningococică 5. Borrelioza Lyme (Boala Lyme) 6. Botulismul * 7. Bruceloza * 8. Criptosporidioza * 9. Dermatomicozele 10. Difteria * 11. Echinococoza * 12. Enterobioza (oxiuriaza) 13. Febra Galbenă * 14. Febra hemoragică de Crimeea-Congo * 15. Febra hemoragică Lassa * 16. Febra hemoragică Marburg/Ebola * 17. Febra Q * 18. Febra tifoidă şi paratifoidă * * * Page 82 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 19. Gonorea * 20. Gripa aviară * 21. Gripa umană * 22. Hepatita virală A * 23. Hepatita virală B * 24. Hepatita virală C * 25. Hepatita virală D 26. Hepatita virală E 27. Himenolepidoza 28. Holera * 29. Infecţia cu Campylobacter * 30. Infecţia cu Citomegalovirus 31. Infecţia cu Escherichia coli Entero- Hemoragică (EHEC) 32. Infecţia enterovirală 33. Infecţia genitală cu Chlamidia trachomatis * 34. Infecţia cu Haemophilus influenzae tip b, invazivă * 35. Infecţia rotavirală 1 2 * 3 36. Infecţia cu Streptococcus pneumoniae, invazivă * 37. Infecţia cu virusul West Nile * 38. Infecţia cu virusurile Herpes simplex 39. Lambliaza (Giardiaza) * Legioneloza * 41. Leptospirozele * 42. Listerioza * 43. Malaria (paludismul) * 44. Mononucleoza infecţioasă 45. Oreionul (parotidita epidemică) 40. * TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 46. 47. Page 83 of 95 Ornitoza Pertussis (tusea convulsivă) * 48. Pesta * 49. Poliomielita paralitică * 50. Rabia umană (turbarea) * 51. Rubeola şi rubeola congenitală * Rujeola * 53. Salmonelozele (non-typhi, non-paratyphi) * 54. Scabia 55. Scarlatina 56. Shigellozele * 57. Sifilisul * 58. Sindromul acut respirator sever (SARS) * 59. Sindromul Imunodeficienţei Dobândite (SIDA) * 60. Infectarea cu HIV * 61. Tetanosul neonatal 62. Tetanosul şi tetanosul obstetrical 63. Tifosul exantematic şi boala Brill 64. Toxoplasmoza * 65. Trichineloza (Trichinoza) * 66. Trichocefaloza (Trichuriaza) 67. Tuberculoza * 68. Tularemia * 69. Variantă nouă a maladiei Creutzfeldt-Jakob * 70. Varicela 71. Variola * 72. Yersinioza * 52. II. Probleme speciale de sănătate * TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Page 84 of 95 73. Boli diareice acute 74. Infecţii acute ale căilor respiratorii superioare 75. Infecţii nosocomiale * 76. Reacţii adverse şi complicaţii postvaccinale * 77. Rezistenţa antimicrobiană * 78. Toxiinfecţii alimentare * Page 85 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Annex 5. Health Emergency Response Organisations Governmental Level Civil Protec Public Health Legal draft Exec Plan Oper Evid base Info Mgnt Train Eval Responsibilities x Main body responsible for implementing preventive measures, verifying emergency preparedness and managing emergency situations, generated by all hazards. The Commission is chaired by the Prime Minister and includes representatives from all ministries and departments. Government Commission for Emergency Situations x The Commission has executive functions for prevention and response in all-hazard emergencies. The Commission is chaired by the Prime Minister. The Deputy-Prime Ministers, the Minister of Internal Affairs and the Head of Civil Protection and Emergency Situations Service of the MIA are Vice-Chairmen. The Commission’s composition includes the heads of relevant Central Public Authorities. Civil Protection and Exceptional Situations Service (CPESS) x x x x x National multi-sectorial agency and working body of the Government Commission for Emergency Situations, under the authority of the Ministry for Internal Affairs, and acting as the secretariat (implementing body) of the Government Commission. Responsible for development of the National Multisectoral Plan for Civil Protection that includes components from the sector plans of the ministries and government agencies. National Extraordinary Commission for Public Health x x x x Responsible for an integrated approach on prevention and management measures, multi-sectorial mobilization and coordination of response to public health threats and emergencies. Ensures an adequate degree of preparedness for public health emergencies and their management. One of the Deputy-Prime Ministers is appointed as Commission's Chairman and Minister of Health is appointed as Vice-Chairman. The Commission’s composition includes heads (or deputies) of relevant Central Public Page 86 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Authorities, as well the chiefs of central level health structures. The Commission has the right to declare/cancel the state of emergency in Public Health. Coordinating bodies subordinated to the Ministry of Health MoH Commission for Emergency Situations x x Under the authority of the MoH. Ensuring an adequate degree of the Health System preparedness for public health emergencies, as well as providing management of measures on prevention, mitigation, response and recovery in case of their occurrence. State Public Health Surveillance Service x Includes the National Center for Public Health, Public Health Centers of Chisinau and Balti municipalities and 34 public health centers at district level. In case of emergency situations such as outbreaks the public health centers perform antiepidemic and sanitary-hygienic measures. The public health centers are part of the National laboratory Network. National Scientific and Practical Centre of Emergency Medicine (NSPCEM) x x Tertiary level medical institution, providing emergency medical care, including for mass casualty. NSPCEM is a coordinating body of the Medical Emergency Service and Disaster Medicine Service. Centre for Disaster Medicine (RCDM) x x x x x x (A specialized subdivision within NSPCEM) is responsible for planning and coordinating the work of all components of the Disaster Medicine Service. RCDM gathers and analyzes information on potential risks triggering emergency situations, plans the organisation of medical care in cases of mass casualty, performs training of medical personnel of the health institutions in preparedness and response to public health emergencies, and evaluates the level of preparedness of medical institutions. In case of threat or outbreak of large-scale RCDM’s staff is deployed to the MoH and provides operational guidance to the Commission’s Page 87 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Operative Command Center. National Centre of Public Health (NCPH) x x x x x Implementing body of the National Extraordinary Public Health Commission. Scientific, technical and coordinating institution of the MoH Service of State Surveillance. NCPH provides evidence basis for public health policies and strategies, develops drafts for sanitary regulations, methodologies and other acts on public health, ensures research and development of expertise, provides support to rayon and municipal Centres of Public Health and performs other activities on Public Health Surveillance. NCPH’s functions include emergency preparedness and interventions in public health emergencies, in collaboration with the relevant services of other ministries and central authorities. NCPH is the designated National Focal Point for International Health Regulations (IHR). At this end the Section of public health alerts monitoring and disease notification, performs early warning functions. LocaL Level Emergency Medicine Zonal Stations x x Functional and structural components of the Medical Emergency Service at the prehospital stage. They are accountable to the Ministry of Health and provide emergency medical care in their jurisdictions (zone). They include district Emergency Medicine Substations and Emergency Medicine Points, located in the served area. Currently there are 4 Emergency Medicine Zonal Stations in the country: North, Central, South and Autonomous Territory of Gagauzia. x Provides emergency medical assistance to population in pre-hospital stage (including in cases of mass casualty events) and assisted medical transportation of patients from the accident or illness area to designated health facilities. Structurally the Service consists of NSPCEM, which is both a specialized Emergency Medical Assistance Service x Page 88 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 hospital and coordination body of the Service, 4 Emergency Medicine Zonal Stations with 41 Emergency Medicine Substations and 88 Emergency Medicine Points. Distributed in the country there are about 250 ambulance team on duty, as first response for emergency medical assistance of population in case of mass casualty events. Hospital system x x Consists of: a) 62 public hospitals, including: - 34 district hospitals; - 10 municipal hospitals; - 18 republican hospitals; b) 10 departmental hospitals; c) 10 private hospitals. The total number of public hospital beds is tallying up to 20,021 (561.0 hospital beds per 100,000 people). Over 50 per cent of hospitals (16 national hospitals, 9 municipal hospitals, 8 public departmental hospitals and 8 private hospitals) with 9,369 beds overall, or 46.8 per cent of the total number of hospital beds, are in the municipality of Chisinau. The remaining hospitals, most of which are district-level inpatient facilities, are located all over the country. Medical units x x In addition to their basic functions, most medical institutions are required to create and maintain units with different healthcare profiles. According to the national Plan of health care in the event of Emergency Situations health care institutions in the country are responsible to maintain the following number of units: - paramedical teams – 620; - medical teams – 488 - specialized medical teams – 90 - preventive medicine teams – 42 medical detachments - 3 x Based at family doctors' centers, health centers, district and municipal hospitals to be mobilized in case of emergency, together with ambulance teams, prehospital medical and emergency care. x Usually created by republican and municipal hospitals in order to strengthen the capacity of medical institutions, directly involved in providing medical assistance in emergency situations, by providing specialized medical care. Paramedical and medical teams x Specialized medical teams x Page 89 of 95 TECHNICAL ASSESSMENT REPORT - MOLDOVA 2014 Civil Protection’s first aid teams x x Teams created on voluntary principle by private companies, enterprises, educational institutions, local authorities, etc. to provide first aid to injured people in emergency situations, their evacuations outside the outbreak zone and their concentration in gathering points. The responsibility for the aid teams’ preparedness lies on the directors of facilities to which they belong. In the event of a public health threat or outbreak the teams go under the responsibility of the health authority of the respective emergency situation’s commission.