PROJECT IMPLEMENTATION PLAN INTEGRATED DISEASE SURVEILLANCE PROJECT (IDSP) 14th May 2004 Government of India Ministry of Health and Family Welfare Department of Health Nirman Bhawan, New Delhi Table of Contents PART 1 : RATIONALE FOR AN INTEGRATED DISEASE SURVEILLANCE PROJECT IN INDIA ................................................................................................................... 2 1 2 3 4 5 6 7 Background .................................................................................................................... 3 1.1 Burden of disease due to communicable diseases ............................................. 3 1.2 Increased risk of diseases and epidemics ........................................................... 4 1.3 Human and economic burden of epidemics ....................................................... 5 1.4 Relative burden of communicable & non communicable diseases & their risk factors ................................................................................................................. 5 1.5 Disease control efforts and role of surveillance ................................................. 6 National commitment to improve disease surveillance ................................................. 6 2.1 Central Council of Health and Family Welfare ................................................. 6 2.2 Technical Advisory Committee on plague ........................................................ 7 2.3 Committee on National Mission on Environmental Health and Sanitation ....... 7 2.4 Expert committee on Revamping of Public Health System............................... 7 2.5 National Apical Advisory Committee (NAAC) ............................................... 7 2.6 Technical Advisory Group on diseases of international public health importance.......................................................................................................... 7 2.7 Pilot project for surveillance of communicable diseases ................................... 8 2.8 Existing components for disease surveillance in disease control programs ...... 8 Current status of surveillance in the country ................................................................. 8 3.1 Conclusions from FGDs with health workers and women ................................ 9 3.1.1 Perceptions of health workers about surveillance ........................................... 9 3.1.2 Constraints perceived by health workers in performing high quality disease surveillance activities .................................................................................... 11 3.1.3 Gender issues in disease surveillance ........................................................... 12 3.2 Conclusions from state level workshops.......................................................... 13 3.2.1 Primary level ................................................................................................. 13 3.2.2 District........................................................................................................... 13 3.2.3 State............................................................................................................... 13 3.2.4 Poor integration and duplication of surveillance activities ........................... 14 3.3 Recommendations based on the above reports ................................................ 14 3.3.1 Process of Disease Surveillance.................................................................... 14 3.3.2 Involvement of Private Sector ...................................................................... 16 3.3.3 Community involvement .............................................................................. 16 3.3.4 Social Mobilization ....................................................................................... 17 Evolution of IDSP In India .......................................................................................... 17 4.1 Development of project implementation plan.................................................. 17 4.2 Developing consensus on IDSP in participating states .................................... 18 4.3 National workshop ........................................................................................... 19 Implementation Strategy .............................................................................................. 19 Special assessment carried out for IDSP ..................................................................... 20 Program sustainability ................................................................................................. 20 PART – II : OBJECTIVES AND COMPONENTS ..................................................................... 21 8 Objectives of integrated disease surveillance .............................................................. 22 9 Components of proposed IDSP .................................................................................... 22 10 Diseases to be included in the surveillance Project ..................................................... 27 10.1 List of Core Diseases: ...................................................................................... 27 10.2 Additional State Priorities ................................................................................ 28 11 Methods of surveillance ............................................................................................... 29 12 Surveillance of Risk Factors for Non communicable disease and their risk factor ..... 31 12.1 Aims ................................................................................................................. 31 12.2 Method ............................................................................................................. 32 12.3 Logistics ........................................................................................................... 33 PART – III : SURVEILLANCE MECHANISMS ........................................................................ 34 13 Reporting units ............................................................................................................. 35 13.1 Rural ................................................................................................................. 35 13.2 Urban................................................................................................................ 35 13.3 Special Units .................................................................................................... 35 14 Structural Framework of IDSP .................................................................................... 37 14.1 Urban surveillance ........................................................................................... 37 15 Integrating private practitioners in surveillance .......................................................... 39 15.1 Identification and selection of sentinel private practitioners (SSPPS) ............ 39 15.2 Recruitment of Private Practitioners to be Sentinel Sites in IDSP .................. 39 15.3 Sentinel private laboratory sites ....................................................................... 40 15.4 Number of private sentinel reporting sites ....................................................... 40 15.5 Phased Induction .............................................................................................. 41 15.6 Facilitating reporting by private sentinel sites ................................................. 41 15.6.1 Simplified Formats........................................................................................ 41 15.6.2 Frequency of Reporting ................................................................................ 41 16 Medical colleges .......................................................................................................... 42 16.1 Responsibility of Integrating Medical Colleges: ............................................. 43 17 Development of operations manuals ............................................................................ 43 18 Analysis........................................................................................................................ 45 18.1 Types of analysis.............................................................................................. 45 18.2 GIS Software .................................................................................................... 45 19 Surveillance actions ..................................................................................................... 46 19.1 Feedback and sharing information ................................................................... 46 19.1.1 Periphery ....................................................................................................... 46 19.1.2 District........................................................................................................... 46 19.1.3 State............................................................................................................... 46 19.1.4 Center ............................................................................................................ 47 19.3 Levels of response............................................................................................ 50 19.4 Response to surveillance challenges ................................................................ 51 19.5 Response at local level ..................................................................................... 51 19.6 Outbreak investigations and response .............................................................. 51 19.6.1 Definition of outbreak ................................................................................... 52 19.6.2 Threshold levels ............................................................................................ 52 19.6.3 Sources of information .................................................................................. 52 19.6.4 Verification of the outbreak .......................................................................... 52 19.6.5 Investigating an outbreak .............................................................................. 53 19.6.6 The District Outbreak Investigation Team (DO IT) ..................................... 53 19.6.7 Outbreak Response ....................................................................................... 54 19.6.8 Daily situation updates .................................................................................. 55 19.6.9 Interim report of DEIT .................................................................................. 55 19.6.10 Final Report of DEIT .................................................................................... 55 19.7 Epidemic investigation and response at state level .......................................... 56 19.8 Disaster management ....................................................................................... 56 20 Administrative structure of IDSP................................................................................. 58 20.1 Administrative structure at the national level .................................................. 58 20.2 The functions of the central surveillance unit .................................................. 60 20.3 Administrative structure at state level.............................................................. 61 20.3.1 State Surveillance Committee ....................................................................... 62 20.4 Administrative structure at district level .......................................................... 63 20.4.1 District Surveillance Committee ................................................................... 63 20.5 Mechanisms for vertical coordination between various levels ................................ 64 20.5 List of partners and key stakeholders............................................................... 65 20.6 National Institute of Communicable Diseases (NICD) .................................. 65 20.7 Indian Council of Medical Research (ICMR) ................................................. 66 20.8 Central Bureau of HeaIth Intelligence ............................................................. 66 20.9 National Institute of Biologicals ...................................................................... 66 20.10 Other agencies in the country doing surveillance ............................................ 67 20.10.1 Pollution control boards ................................................................................ 67 20.10.2 Water boards ................................................................................................. 67 20.10.3 Police administration at the states ................................................................. 67 20.10.4 Medical colleges ........................................................................................... 67 20.10.5 Private practitioners ...................................................................................... 67 20.10.6 Other NGOs doing surveillance .................................................................... 68 20.11 International partners ...................................................................................... 68 20.12 Technical partners ........................................................................................... 68 20.12.1 Centers for Disease Control – USA (CDC) .................................................. 68 20.12.2 IndiaCLEN Network ..................................................................................... 69 PART – IV : SPECIFIC INPUTS TO IMPROVE DISEASE SURVEILLANCE ..................... 70 21 Laboratory network for IDSP ..................................................................................... 71 21.1 Peripheral laboratories (L1 Laboratories) ....................................................... 71 21.2 Private laboratories .......................................................................................... 72 21.3 Additional needs for peripheral laboratories.................................................... 72 21.4 District public health laboratory (L2 Laboratories) ........................................ 73 21.4.1 Administrative structure and personnel in District PH Lab .......................... 74 21.4.2 Needs at district laboratories ......................................................................... 75 21.4.3 Other laboratories which may function as District PH Laboratories ............ 76 21.5 State public health laboratories ........................................................................ 76 21.6 Administrative Re-organization for Laboratory Work under IDSP ................ 78 21.7 Quality Assurance: ........................................................................................... 78 21.8 Reference laboratories ..................................................................................... 78 21.8.1 Strengthening National Institute of Communicable Diseases ...................... 79 21.8.2 National Institute of Cholera and Enteric Diseases, Calcutta as regional IDSP laboratory in the Eastern region .......................................................... 79 21.8.3 Microbiology PGI Chandigarh as the regional IDSP laboratory for the Northern region ............................................................................................. 79 21.8.4 Microbiology Center at CMC Vellore regional Reference Center for the Southern Region............................................................................................ 80 21.8.5 National institute of Virology, Pune regional IDSP reference laboratory for the Western Region ....................................................................................... 80 21.9 Role of ICMR centers in coordinating Disease Specific Reference Laboratories in the country .............................................................................. 80 21.10 Additional Reference Laboratories for quality control and accreditation ...... 82 21.10.1 National Institute of Biologicals with AIIMS Delhi and CMC Vellore ....... 82 21.10.2 National Accreditation Board for Testing and Calibration of Laboratories . 82 22 Biosafety and bio-medical waste management ............................................................ 82 22.1 Bio-safety issues in the proposed IDSP ........................................................... 83 22.2 Improving health practices especially handling of sharps ............................... 83 22.3 Improving infrastructure .................................................................................. 83 23 Information technology in IDSP .................................................................................. 84 23.1 Proposed IDSP information technology infrastructure and networking .......... 85 23.2 IT Infrastructure for IDSP ................................................................................ 88 23.2.1 System Software and Packages:- .................................................................. 88 23.2.2 Hardware and Networking: ........................................................................... 89 23.3 Software licenses ............................................................................................. 91 23.4 Administration ................................................................................................. 91 23.4.1 Security administration ................................................................................. 91 23.4.2 Network administration ................................................................................ 91 23.4.3 Database administration ................................................................................ 91 23.4.4 Server administration .................................................................................... 91 23.5 Failure and disaster recovery ........................................................................... 92 23.5.1 Server failure ................................................................................................. 92 23.5.2 Network failure ............................................................................................. 92 23.5.3 Inter-state network failure ............................................................................. 92 23.6 Computer virus attack ...................................................................................... 92 23.7 Management of total computer failure ............................................................. 92 24 Training needs in IDSP ................................................................................................ 92 24.1 Training Needs Assessment: ............................................................................ 93 24.2 Training Strategy: ............................................................................................ 95 24.2.1 The Sensitization Workshops ....................................................................... 95 24.2.2 Types of Induction Training Programs: ........................................................ 96 24.3 Who will provide the training .......................................................................... 96 24.3.1 National Network of training Institutions – Level 1: .................................... 96 24.3.2 Level -2 Trainers: .......................................................................................... 97 24.3.3 Level 3 Trainers: ........................................................................................... 98 24.4 Quality Assurance: ........................................................................................... 98 24.5 Site of Training: ............................................................................................... 99 24.6 The Training Curricula .................................................................................. 100 24.7 Training Plan .................................................................................................. 102 24.8 Integrating existing public health training programs for training .................. 103 24.9 24.10 25.2 25.3 25.4 25.4.1 25.4.2 25.5 Institutional capacity to undertake training in different states ....................... 103 Conclusion: .................................................................................................... 104 Socio-cultural issues to be taken up for social mobilization campaign ......... 105 Gender Issues in Surveillance ........................................................................ 105 Stakeholder who can be involved .................................................................. 105 Rural areas .................................................................................................. 105 Urban areas ................................................................................................. 105 Social mobilization strategies ........................................................................ 106 PART – V 108 : QUALITY ASSURANCE ............................................................................. 108 26 Quality assurance in IDSP ......................................................................................... 109 26.1 Supervision .................................................................................................... 112 26.2 Monitoring and evaluation ............................................................................. 112 26.2.1 Surveillance Reports ................................................................................... 113 26.3 Indicators for monitoring the program ........................................................... 114 26.4 Independent external evaluation of the surveillance and response ................ 117 26.5 Quality assurance of laboratory services in IDSP.......................................... 117 26.5.1 Role of National Centers for Quality Control ............................................. 118 26.6 Accreditation .................................................................................................. 119 26.7 Role of National Institute of Biologicals ....................................................... 119 PART – VI : ENVIRONMENT MANAGEMENT PLAN &TRIBAL DEVELOPMENT PLAN ........ 121 27 Environment Management Plan ................................................................................. 122 27.1 Project Context............................................................................................... 122 27.2 Scope of the Project ....................................................................................... 122 27.3 Environmental Issues ..................................................................................... 122 27.4 Actions to be taken under this project to address these issues. ...................... 123 27.5 Project Implementation .................................................................................. 123 27.6 Key Activities under the project: ................................................................... 124 27.7 Costs and resources ........................................................................................ 124 27.8 Monitoring ..................................................................................................... 125 27.9 Schedule of Implementation .......................................................................... 125 28 Strategy for Tribal Populations .................................................................................. 126 28.1 Tribals in IDSP .............................................................................................. 126 28.2 Integrated Disease Surveillance Project......................................................... 127 28.2.1 Project Benefits ........................................................................................... 128 28.2.2 Legal Framework ........................................................................................ 128 28.2.3 Methodology for Preparation of Tribal Strategy ........................................ 129 28.3 Study of community-based disease surveillance systems .............................. 133 28.4 Institutional Mechanisms ............................................................................... 134 28.5 Implementation and Local Participation ........................................................ 135 28.6 Cost estimate and financing plan ................................................................... 137 28.7 Monitoring and Evaluation ............................................................................ 137 PART – VII : STRATEGIES FOR INVOLVEMENT OF PRIVATE SECTOR IN DISEASE SURVEILLANCE................................................................................................. 139 29 Strategies for Involvement of private Sector in Disease Surveillance ....................... 140 29.1 Initiate Partnership With Private Health Providers For Disease Surveillance ........................................................................................................................ 140 29.2 29.3 29.4 29.5 29.6 29.7 29.8 29.9 29.10 29.11 29.12 Selection of SSPs ........................................................................................... 140 Method of Selecting the Sentinel Surveillance Unit ...................................... 140 Number of Sentinel Surveillance Units ......................................................... 141 Data Collection and Transmission ................................................................. 141 Integrating Private Sector under IDSP ........................................................... 143 Increasing Sensitivity of Reporting Units ...................................................... 143 Maintaining quality of Reporting................................................................... 143 Sustainability of Partnership .......................................................................... 144 Continuing Medical Education Session: ....................................................... 145 Other Determinants of Sustainability: ........................................................... 145 Evaluation ..................................................................................................... 146 PART – VIII 147 Procurement of goods & services ................................................................................................. 147 30 Procurement of goods and services............................................................................ 148 30.1 Civil Works: Renovation and Repair [Annexure 1] ...................................... 148 30.2 Goods & Equipment ...................................................................................... 150 30.3 Services .......................................................................................................... 154 30.4 Incremental Operational Cost [Annexure 13 & 13/I] .................................. 159 30.5 Prior Review Thresholds................................................................................ 160 PART – IX : FINANCIAL MANAGEMENT ............................................................................. 161 31 Financial Management ............................................................................................... 162 31.1 Summary Project Description ........................................................................ 162 31.2 Implementing Agency:................................................................................... 163 31.2.1 Central level ................................................................................................ 164 31.2.2 State level .................................................................................................... 164 31.2.3 District level ................................................................................................ 164 31.3 Finance Staffing and Training: ...................................................................... 164 32 Budgeting ................................................................................................................... 165 32.1 Funds Flow: ................................................................................................... 165 32.1.1 Central level: ............................................................................................... 165 32.1.2 State level .................................................................................................... 165 32.1.3 District level ................................................................................................ 166 32.2 Books of account, accounting policies and procedure: .................................. 166 32.3 Information and Reporting System: ............................................................... 167 32.4 Audit (External ) ............................................................................................ 167 32.5 Internal Audit: ................................................................................................ 168 32.6 Retroactive Financing: ................................................................................... 168 32.7 Disbursement and Payment Arrangements:- ................................................. 168 ANNEXURES .............................................................................................................................. 170 ACKNOWLEDGEMENT The Project Implementation Report (PIP) was written with contributions from grassroots level health workers from three states of Tamil Nadu, Maharashtra and Uttar Pradesh. We gratefully acknowledge their contribution during the state level workshops and focus group discussions conducted for developing the DPR. We also acknowledge the inputs of Directors of Public Health and the State Surveillance Officers from the above three states, without which this would not have been possible. We particularly want to thank Dr. .P. Krishnamurthy, Dr. T. J. Agustine from Tamil Nadu, Dr. S. Salunke and Dr. R. R. Katti from Maharashtra for their contributions. Many technical assessment groups were involved in developing this document. We want to specially thank Dr. Ashish Mathur (IT consultant), Dr. Robert Martin, Dr. Ronald Cada and Dr. Loris Hughes (CDC team), Dr. Davadasan (WHO) and Dr. Sampat Krishnan (WHO) who have contributed to development of this document. United States Agency for International Development (USAID) and the World Bank (WB) provided financial and technical support for developing state and national PIPs. Dr. Peter Heywood, Dr. K. Sudhakar, Mrs. Rashmi Sharma, Mr. Mamchand and Mr. Mohan Gopalakrishnan (World Bank) and Dr. Victor Barberio and Dr. Dora Warren (USAID) played crucial supportive roles. We are grateful to the Ministry of Health and Family Welfare, Government of India (GOI) for giving us this opportunity to participate in an important public health activity. We particularly thank Mr. JVR Prasada Rao (Secretary, Health), Dr. S.P.Agarwal, DGHS, Mrs. P. Jyoti Rao, Additional Secretary, Dr. Shivlal, Director NICD, Mrs. Bhavani Thyagarajan and Shri. B.P.Sharma, Joint Secretary, Department of Health, who have interacted with us actively in the preparation of the PIP. We acknowledge Ms. Jyoti Bahri and Ms. Vaishali Chaturvedi for their contribution in editing and giving final touch to the document. A great deal of work was done by the PIP team of the INCLEN network particularly Dr. Kurien Thomas, Dr. N. K. Arora, Dr. Srinath Reddy, Dr. Ramesh Ahuja, Dr. P. P. Joshi, Dr. Sunitha Shanbagh, Dr. Saradha Suresh, and Dr. Nalini Ramamurthy. This has indeed been a team effort. i ABBREVIATIONS AIDS AFP AMR ANM API ASI CAG CBHI CCHFW CDC CFR CMC CSU CVD DALY DCP DEA DEIT DFID DGHS DHS DME DOTS DSO DSU EMP EQA EPI FGDs AFMC GASP GOI GIS HBV HCV HIV IAP IBRD ICDS ICMR IDA IDSP IEC IFEPT - Acquired Immuno Deficiency Syndrome Acute Flaccid Paralysis Anti Microbial Resistance Auxiliary Nurse Midwife Association of Physicians India Association of Surgeons India Controller and Auditor General of India. Central Bureau of Health Intelligence Central Council of Health and Family Welfare Centers for Disease Control Case Fatality Rates Christian Medical College Central Surveillance Unit Cardio Vascular Disease Disability Adjusted Life Years Diploma in Clinical Pathology Department of Economic Affairs District Epidemic Investigation Team Department for International Development Director General of Health Services Director of Health services Director of Medical Education Direct Observed Treatment, Shortcourse District Surveillance Officer District Surveillance Unit Environment Management Plan External Quality Assurance Expanded Program on Immunization Focus Group Discussions Armed Forces Medical College Gonococcal Antimicrobial Susceptibility Testing Program Government of India Geographical Information System Hepatitis B Virus Hepatitis C Virus Human Immuno Deficiency Virus Indian Association of Pediatrics International Bank for Reconstruction and Development Integrated Child Development Services Indian Council of Medical Research International Development Association Integrated Disease Surveillance Project Information Education and Communication Internal Federation of Enteric Phage Typing ii IMA INCLEN IndiaCLEN IT ISM M&E MOHFW MOU JE FETP FMR IEQUAS MOU NACP NAAC NABL - NAMP NARI NADI NCD NCDS NGO NIB NICD NICED NIE NIH NIV NLEP NPV NPSCD PHC PIP PRI RCH RMP RRT RTI RTA SC/ST SHSP SPH SPPs SSO SSPPS - Indian Medical Association International Clinical Epidemiology Network Indian Clinical Epidemiology Network Information Technology Indian System of Medicine Monitoring and Evaluation Ministry of Health and Family Welfare Memorandum of Understanding Japanese Encephalitis Field Epidemiology Training Program Financial Monitoring Report Internal and External Quality Assurance system Memoranda of Understanding National AIDS Control Program National Apical Advisory Committee National Accreditation Board for Testing and Calibration Laboratories National Anti-Malarial Program National Aids Research Institute North Arcot District Information Non-Communicable Diseases Non Communicable Disease Surveillance Non Governmental Organization National Institute of Biologicals National Institute of Communicable Diseases National Institute of Cholera and Enteric Diseases National Institute of Epidemiology National Institute of Health National Institute of virology National Leprosy Elimination Program Net Present Value National Program for Surveillance of Communicable Diseases Primary Health Center Project Implementation Plan Panchayati Raj Institutions Reproductive and Child Health Registered Medical Practitioner Rapid Response Team Reproductive Tract Infection Road Traffic Accidents Schedule Caste / Schedule Tribe State Health Systems Project Sentinel Private Hospital Sentinel Private Practitioners State Surveillance Officer Selected Sentinel Private Practitioners iii STD TB TOTs UNICEF USAID VCRC VHAI WAN WHO WB WMP - Sexually Transmitted Disease Tuberculosis Training of Trainers United Nations Children’s Fund United States Agency for International Development Vector Control Research Center Voluntary Health Association of India Wide Area Network World Health Organization World Bank Waste Management Plan iv EXECUTIVE SUMMARY INTEGRATED DISEASE SURVEILLANCE PROJECT Background The Government of India is initiating a decentralized, state based Integrated Disease Surveillance Project (IDSP) in the country in response to a long felt need expressed by various expert committees. The project would be able to detect early warning signals of impending outbreaks and help initiate an effective response in a timely manner. It is also expected to provide essential data to monitor progress of on going disease control programs and help allocate health resources more optimally. Objectives The project development objective is to improve the information available to the government health services and private health care providers on a set of high-priority diseases and risk factors, with a view to improving the on-the-ground responses to such diseases and risk factors. Specifically, the projects aims: To establish a decentralized state based system of surveillance for communicable and non-communicable diseases, so that timely and effective public health actions can be initiated in response to health challenges in the country at the state and national level. To improve the efficiency of the existing surveillance activities of disease control programs and facilitate sharing of relevant information with the health administration, community and other stakeholders so as to detect disease trends over time and evaluate control strategies. The project will assist the Government of India and the states and territories to: surveil a limited number of health conditions and risk factors; strengthen data quality, analysis and links to action; improve laboratory support; train stakeholders in disease surveillance and action; coordinate and decentralize surveillance activities; integrate disease surveillance at the state and district levels, and involve communities and other stakeholders, particularly the private sector. Components Component 1. Establish and Operate a Central-level Disease Surveillance Unit. Under this component, Ministry of Health and Family Welfare (MOHFW) will establish a new Disease Surveillance Unit at the central level to help coordinate and decentralize disease surveillance activities. The new unit will support and complement the states' disease surveillance v efforts. The unit will be staffed by existing permanent staff reassigned from within the MOHFW. This component will address the constraints of lack of coordination despite central control of surveillance activities and the need for changing the diseases included in the system. Effective coordination (as compared to control) of disease surveillance activities depends on establishing the appropriate processes and institutional arrangements at the central level. This will be done through the creation of a small disease surveillance unit to support the states disease surveillance efforts. Component 2. Integrate and strengthen disease surveillance at the state and district levels. This component addresses the constraints imposed by lack of coordination at the sub-national levels, the limited use of modern technology and data management techniques, the inability of the system to act on information and the need for inclusion of other stakeholders. It will integrate and strengthen disease surveillance at the state and district levels, and involve communities and other stakeholders, in particular, the private sector. Component 3. Improve laboratory support. This component will consist of: (i) upgrading laboratories at the state level, in order to improve laboratory support for surveillance activities. Adequate laboratory support is essential for providing on-time and reliable confirmation of suspected cases; monitoring drug resistance; and monitoring changes in disease agents; (ii) introducing a quality assurance system for assessing and improving the quality of laboratory data. Component 4. Training for disease surveillance and action. The changes envisaged under the first three components will require a large and coordinated training effort to reorient health staff to an integrated surveillance system and provide the new skills needed. Training programs will include representatives from the private sector, NGOs and community groups. Project Highlights It will monitor a limited number of conditions based on state perceptions including 13 core and 5 state priority conditions for which pubic health response is available. District, State & Central Surveillance units will be set up so that the program is able to respond in a timely manner to surveillance challenges in the country including emerging epidemics. It will integrate surveillance activities in the country under various programs and use existing infrastructure for its function. Private practitioners / Private hospitals / Private laboratories will be inducted into the program as sentinel units. Active participation of medical colleges in the surveillance activities. The project will ensure uniform high quality surveillance activities at all levels by vi (i) (ii) (iii) (iv) (v) (vi) Limiting the total number of diseases under surveillance and reducing overload at the periphery Developing standard case definitions Developing formats for reporting Developing user friendly manuals Providing training to all essential personnel, and Setting a system of regular feed back to the participants on the quality of surveillance activity. District Public Health Laboratory will be strengthened to enhance capacity for diagnosis and investigations of epidemics and confirmation of disease conditions. Use of information technology for communication, data entry, analysis, reporting, feedback and actions. A national level surveillance network will be established up to the district level. Diseases conditions under the surveillance program (i) Regular Surveillance: Vector Borne Disease Water Borne Disease Respiratory Diseases Vaccine Preventable Diseases Diseases under eradication Other Conditions Other International commitments: Unusual clinical syndromes (Causing death / hospitalization) (ii) : 1. : 2. : 3. : 4. : 5. : 6. : 7. : 8. : 9. Sentinel Surveillance Sexually transmitted diseases/Blood borne : 10 Other Conditions : 11 : 12 (iii) HIV/HBV, HCV Water Quality Outdoor Air Quality (Large Urban centers) Regular periodic surveys: NCD Risk Factors (iv) Malaria Acute Diarrhoeal Disease (Cholera) Typhoid Tuberculosis Measles Polio Road Traffic Accidents (Linkup with police computers) Plague Menigoencephalitis/Respiratory Distress Hemorragic fevers, other undiagnosed conditions : 13 Anthropometry, Physical activity, Blood Pressure, Tobacco, Nutrition, Blindness Additional State Priorities : Each state may identify up to five additional conditions for surveillance. vii Note: GOI may include in a public health emergency any other unusual health condition. Project funds could be used for such emergencies and reimbursed by IDA subject to agreement at the next joint project review mission. Phasing Phase I (commencing from FY 2004-05) Andhra Pradesh, Himachal Pradesh, Karnataka, Madhya Pradesh, Maharashtra, Uttaranchal, Tamil Nadu, Mizoram & Kerala Phase II (commencing from FY 2005-06) Chhatisgarh, Goa, Gujarat, Haryana, Rajasthan, West Bengal, Manipur, Meghalaya, Orissa, Tripura, Chandigarh, Pondicherry, Delhi Phase III (commencing from FY 2006-07) Uttar Pradesh, Bihar, Jammu & Kashmir, Jharkhand, Punjab, Arunachal Pradesh, Assam, Nagaland, Sikkim, A & N Nicobar, D & N Haveli, Daman & Diu, Lakshdweep. Key performance indicators: Key aspects of overall performance of the surveillance system will be assessed using the following indicators: Number and percentage of districts providing monthly surveillance reports on time - by state and overall; Number and percentage of responses to disease-specific triggers on time - by state and overall; Number and percentage of responses to disease-specific triggers assessed to be adequate by state and overall; Number and percentage of laboratories providing adequate quality of information - by state and center; Number of districts in which private providers are contributing to disease information; Number of reports derived from private health care providers; Number of reports derived from private laboratories; # and % of states in which surveillance information relating to various vertical disease control programs have been integrated # and % of project districts and states publishing annual surveillance reports within three months of the end of the fiscal year; Publication by CSU of consolidated annual surveillance report (print, electronic, including posting on the websites) within three months of the end of fiscal year. Expectations Surveillance is the essence of a disease control program. By setting up a decentralized, action oriented, integrated and responsive program, it is expected that IDSP will avert a sufficient number of disease outbreaks and epidemics and reduce human suffering and improve the efficiency of all existing health programs. Such a program will also allow monitoring of resource allocation and form a tool to enhance equity in health delivery. viii YEAR WISE PROJECT COSTS (Rs. in millions) Year 2004-05 2005-06 2006-07 Sub Total (Xth Plan) 2007-08 2008-09 Sub Total (XIth Plan) Grand Total Total 700.0 880.0 1020.0 2600.0 840.0 643.6 1483.6 4083.6 Components-wise Project Costs Non-Recurring : Rs. in Millions Renovation & Furnishing Laboratory Equipments Computer Hardware & Accessories Office Equipments Application Software Furniture & Fixtures IEC Activities Training of Personnel Consultancy (Procurement, Software, Evaluation Studies etc) Sub-total Non Recurring Costs 243.6 641.9 432.6 102.5 220.0 142.5 360.1 204.3 158.6 2506.2 Recurring (for 5 years): Laboratory consumables Personnel Costs Networking Costs Operational & Maintenance Costs Sub-total Recurring Costs 310.5 561.2 125.2 580.6 1577.5 GRAND TOTAL 4083.6 1 PART – I RATIONALE FOR AN INTEGRATED DISEASE SURVEILLANCE PROJECT IN INDIA 2 1 BACKGROUND Integrated Disease Surveillance Program (IDSP) is intended to be the backbone of public health delivery system in the country. It is expected to provide essential data to monitor progress of on going disease control programs and help in optimizing the allocation of resources. It will be able to detect early warning signals of impending outbreaks and help initiate an effective response in a timely manner. IDSP will also facilitate the study of disease patterns in the country and identify new emerging diseases. It will play a crucial role in obtaining political and public support for the health programs in the country. India is currently passing through an epidemiological transition. Many states in India have good health delivery systems while other states are lagging far behind. Health problems of some states are predominantly due to communicable diseases, while in others it is due to noncommunicable diseases. Any system that intends to be futuristic will need to take into account the variability and cater to differential needs in the country. It will need to be decentralized and state specific. The program will need to cater to the wide geo-political and socio-economic differences in the country and tailor its implementation to levels suitable for the given region in the country. Equity in health delivery is one of the primary concerns of the government. Through an effective disease surveillance program, health of vulnerable populations in underdeveloped regions and tribal populations in India will be better understood and corrective steps will be taken to improve their conditions. Surveillance is essential for the early detection of emerging (new) or re-emerging (resurgent) infectious diseases. In the absence of surveillance, disease may spread unrecognized by those responsible for health care or public health agencies, because sick people would be seen in small numbers by many individual health care workers. By the time the outbreak is recognized, it may be too late for intervention measures. Continuous monitoring is essential for detecting the ‘early signals’ of outbreak of any epidemic of a new or resurgent disease. For disease surveillance to prevent emerging epidemics, the time taken for effective action should be short. Empowering the public to be responsible is an important function. Surveillance data can be effectively used for the purpose of social mobilization to help the public participate actively in controlling important diseases. This is an important step in reducing the burden of disease in the community. 1.1 Burden of disease due to communicable diseases The disease burden due to infectious diseases in India is among the highest in the world. Infectious diseases are major causes of admissions in the hospitals and visits to health facilities. Tuberculosis and malaria are the leading causes of deaths in the country. In recent years, India faced the plague outbreak and dengue hemorrhagic fever outbreaks. National lack of preparedness was evident. Various health bodies have issued warnings regarding the importation and spread of yellow fever. Our state of preparedness requires immediate strengthening and surveillance is the key pillar of our state of preparedness. 3 The communicable disease burden as seen through Disability Adjusted Life Years (DALY) loss carried out by World Bank and WHO has shown that there has been some decline in communicable diseases during the last one decade. The table below gives distribution of DALY loss by cause for the world and India for the years 1990 and 1999. TABLE : DISTRIBUTION OF DAILY LOSS BY CAUSE AND DEMOGRAPHIC REGION, 1990 AND 1999 Cause World 1990 India 1990 World 1999 India 1999 Population (Millions) 5,267 850 5,961 995 + Total DALY (Millions) 1,362 292 1438 250 - Communicable diseases (%) 45.8 50.5 39.1 41.2 - Tuberculosis 3.4 3.7 2.3 6.9 + STDs and HIV 3.8 2.7 9.0 4.8 + Diarrhea 7.3 9.6 5.0 6.7 - childhood 5.0 6.7 7.6 4.1 - Malaria 2.6 0.3 3.1 2.4 + Worm infections 1.8 0.9 0.12 1.8 + Respiratory infections 9.0 10.9 7.0 7.9 - Others 12.9 15.7 5.5 6.7 - Vaccine-preventable infections Trend Source:- World Bank Report 1993 World Health Report 2000 1.2 Increased risk of diseases and epidemics Rapid urbanization, industrial and other development activities, encroachment by man on areas so far uninhabited leading to ecological changes, deforestation and rapid means of transportation within the country as well as international travel have increased the risk of diseases and epidemics. Improvement in the living standards and changes in life styles are accompanied by increased health hazards. The receptivity of an area to outbreaks is related to inadequate drinking water facilities, poor sanitary conditions and a weak public health system. Unfortunately, conditions are conducive for outbreaks in most parts of the country. While, not all outbreaks can be predicted or prevented, epidemic preparedness and precautionary measures can reduce the risk of outbreaks, minimize their scale and lessen their impact on human suffering. 4 1.3 Human and economic burden of epidemics The outbreaks of diseases in the past have highlighted the urgency for a disease surveillance system so that early warning signals are recognized and appropriate control measures initiated in a timely manner. Epidemics are public health emergencies that disrupt routine health services and are a major drain on resources. Besides direct costs involved in outbreak control measures and treatment of patients, the indirect costs due to negative impact on domestic and international tourism and trade can be astronomical. The avoidable human misery and loss in productivity resulting from illness and death cannot be quantified in mere economic terms. 1.4 Relative burden of communicable & non communicable diseases & their risk factors Socio-cultural, economic and political diversities in India also reflect on the disease burden. India is going through an epidemiological transition and in many states non-communicable diseases contribute significantly to overall burden of the disease in the community. The table below shows that in the first ten disease conditions related to burden of disease, communicable diseases and non-communicable diseases are more or less equally distributed. Any disease surveillance program capable of responding to the future needs of the people will need to integrate both communicable and non-communicable diseases in its preview. TABLE 1.4 RELATIVE IMPORTANCE OF NON-COMMUNICABLE DISEASE IN INDIA INDIA INDIA/WORLD (000) % of total % of World Total Population 982223 % of total 16.7 Deaths 9337 100 17.3 1 Ischemic Heart Disease 1471 15.8 19.9 2 Lower Respiratory Infections 969 10.4 28.1 3 Diarrheal Disease 711 7.6 32.1 4 Cerebrovascular Diseases 557 6.0 10.9 5 Tuberculosis 421 4.5 28.1 6 Road Traffic Injury 217 2.3 18.5 7 Measles 190 2.0 21.4 8 HIV/AIDS 179 1.9 7.8 9 Tetanus 165 1.8 40.3 5 10 Chronic Obstructive Pulmonary 153 Disease Communicable diseases Non Communicable diseases 1.6 6.8 28.2 25.7 Source World Health Organization 1999 Unlike communicable diseases, most non-communicable diseases are more latent and they occur after a prolonged exposure to life style risk factors like smoking, blood sugar, blood pressure and hyper-cholestremia. Public health action will be primarily directed against preventive strategies for the disease and hence the priority is to monitor risk factors rather than NCD diseases itself. A similar policy has been adopted by WHO on NCD surveillance. 1.5 Disease control efforts and role of surveillance From the preceding introduction it is clear that there is an urgent need for effective control of diseases. There are different approaches for achieving control of diseases. Prophylactic immunization is one such highly cost-effective and powerful method. By the strategic application of immunization, smallpox was eradicated. It is worth pointing out that diseasesurveillance was also an integral part of the strategy of smallpox eradication. The universal application of selected vaccines in infancy and preschool age has resulted in the dramatic decline of childhood tuberculosis, meningitis, diphtheria, whooping cough, poliomyelitis and measles. The selective application of tetanus prophylaxis in pregnancy has resulted in a similar reduction of neonatal tetanus. Diseases can be brought under effective control through early diagnosis and prompt treatment, reducing the number of patients actively transmitting the infection to others. This strategy is being adopted for the tuberculosis control program. A Febrile Flaccid Paralysis (AFP) surveillance under National Polio Eradication Initiative is a robust example of surveillance and its contribution to disease eradication / control efforts. The other examples of targeted disease control programs which are under implementation are: National Anti-malarial Program (NAMP), National AIDS Control Program (NACP) Revised National Tuberculosis Control Programme and National Leprosy Elimination Program (NLEP). In all these programs, surveillance is an important component to facilitate disease control efforts not only through early detection of outbreaks but also by providing valuable data about the impact of the interventions and time trend analysis of disease. This information has helped in midcourse corrections in program strategy wherever necessary. 2 NATIONAL COMMITMENT TO IMPROVE DISEASE SURVEILLANCE The concept of improving disease surveillance has been under active consideration of Government of India. Various political and technical committees have provided considerable support to the concept. 2.1 Central Council of Health and Family Welfare The Central Council of Health and Family Welfare (CCHFW) is the apex political and policy formulating body comprising of Union Minister of Health and Family Welfare (chairperson) 6 and health ministers from all the States / Union Territories of the country as members. The council has recommended the establishment of state and district level epidemiological units and revitalization of procedures of identification and reporting of outbreaks through the primary health care system. The Fourth Conference of the Central Council of Health and Family Welfare took cognizance of the existing inadequate disease surveillance system and recommended that a nation wide disease surveillance program should be launched with the National Institute of Communicable Diseases (NICD) as the national coordinating agency. 2.2 Technical Advisory Committee on plague After the outbreak of plague in 1994, Government of India constituted a technical committee to suggest measures to prevent recurrence of such outbreaks. Initiation of a nation wide effective disease surveillance program was strongly recommended by the Committee. It also suggested the strengthening of disease surveillance activities at all the tiers of health care delivery system. 2.3 Committee on National Mission on Environmental Health and Sanitation An inter-ministerial committee under the chairpersonship of the Union Health Secretary was constituted in 1995 by the Government of India to suggest ways and means to mitigate diseases due to environmental degradation and insanitation. The Committee recommended launching of a Health Surveillance and Support Services. 2.4 Expert committee on Revamping of Public Health System The expert committee constituted in 1995 under the chairpersonship of Member, Planning Commission on Revamping of Public Health System also stressed the need to strengthen the public health system for effective implementation and evaluation of national health programs and prevention of large outbreaks, which had adverse implications at national and international levels. The Committee also identified the surveillance and control of diseases as an important function of public health system. 2.5 National Apical Advisory Committee (NAAC) The Government of India constituted a National Apical Advisory Committee for National Disease Surveillance and Response System (NAAC) vide GO T 21011/8/94-PH (Pt.1), April 1996. The NAAC assigned the task of preparing a Concept Plan to a Sub-Group. This Concept Plan was prepared after extensive deliberations in two sittings of the NAAC and three meetings of the Sub-group. The concept plan prepared by NAAC was circulated to all state governments as well as WHO for their comments. A meeting was convened by the Government of India to formulate the concept plan. State health secretaries and delegates from WHO (Geneva) participated in the meeting. 2.6 Technical Advisory Group on diseases of international public health importance The Government of India constituted a technical advisory group on diseases of international public health importance in 1999. The report submitted by this group highlights the importance of effective surveillance and need for strengthening of infrastructure to meet the 7 growing challenge posed by various microorganisms, which have tremendous international public health importance. 2.7 Pilot project for surveillance of communicable diseases A pilot project called the National Surveillance Program for Communicable Diseases was launched in 1997-98 to strengthen the disease surveillance system so that early warning signals of outbreaks are recognized and appropriate timely follow-up action is initiated. The main objective of the program were capacity building at district and state levels. The program is being implemented through the existing health infrastructure and surveillance system strengthened through training of medical and para-medical personnel, up gradation of laboratories, communication and data processing systems. The program is being implemented through the state health systems. The program at the central level is coordinated by the National Institute of Communicable Diseases, Delhi. It presently covers 100 districts and a budgetary allocation of Rs. 25 crores was made for the program during the Ninth plan. 2.8 Existing components for disease surveillance in disease control programs Most of the existing disease control programs have surveillance components that exist independently, but many do not function in a coordinated manner. The programs with major surveillance components include: The National Anti-Malaria Control Program National Leprosy Elimination Program Revised National Tuberculosis Control Program Nutritional Surveillance National AIDS Control Program National Polio Surveillance Program as part of the Polio eradication initiative National Programme for Control of Blindness (Sentinel Surveillance) Surveillance components have been built into the ‘State Health Systems Projects’ to improve health care infrastructure in various states under World Bank funding. The Family Welfare department carries out surveillance activities for family planning, child and maternal morbidity and mortality. Department of Women and Child conducts surveillance of nutrition through the National Institute of Nutrition. The Integrated Child Development (ICDS) program monitors the nutritional status of children at the village level. For the surveillance system to be efficient and cost effective, all such activities need to be coordinated and information and resources shared. 3 CURRENT STATUS OF SURVEILLANCE IN THE COUNTRY Three state level workshops and ten focus group discussions (FGDs) were conducted with male (five) and female (five) health workers in three states, namely Tamil Nadu, Maharastra and Uttar Pradesh to understand the present status of surveillance activities. In addition, five FGDs were conducted with tribal (two), rural (two) and urban (one) women in Bilaspur district of Chattisgarh. In the following sections the summary findings from FGDs and state level workshops are presented. 8 3.1 Conclusions from FGDs with health workers and women 3.1.1 Perceptions of health workers about surveillance Discussions held with health workers in FGDs revealed that they generally understood disease surveillance related to collecting data regarding occurrence and spread of different disease conditions with relation to time. They felt that the purpose of surveillance was to identify epidemics, study root causes, investigate epidemiological causes and take action to contain the outbreaks. In fact, some of the health workers perceived epidemic investigations as synonymous with surveillance of diseases. House to house visits were perceived as active surveillance and the most important component of the process. Some also mentioned that the data collection at the health facilities constituted passive surveillance, although this data was used rarely. Surveys are also undertaken, as part of surveillance activities. Several health workers thought that whatever information they collected including the demography were part of the surveillance activity. Imparting health education, identifying beneficiaries and delivery of different services to the people under various national health programs were other activities mentioned as part of surveillance. The workers felt that surveillance was useful to forecast epidemics, detect disease outbreaks, evaluate usefulness of the actions taken, treatment given. Surveillance data was useful for taking decisions about new health care policies and programs. Usually data is collected through house visits. It is also obtained from out patient clinics, during various health camps or when patients are admitted to a hospital. In such cases, they also make house visits to collect more information. Many health workers enjoy good relationships with their communities. In their area, people come forward on their own and give them the desired information During the field visits, they have regular contact with the village elders, particularly ladies and the Pradhan, chauwkidar or other community persons who give them information. At times people come forward and tell them about the disease outbreaks in the community and health workers later go to the community to verify the reports. The health workers also get disease information from the ICDS workers during their interactions for other activities. Attempts are made to get surveillance information from local private practitioners but most health workers are not satisfied with the response. Allopathic doctors, RMPs and practitioners of ISM are generally busy with their clinical practice and maintain few records. They pass on the information only if the health workers approach them to get information about specific type of patients or refer those who cannot afford private treatment. Data is recorded in pre-designed formats. These formats are designed according to the needs of various programs. In addition, for other diseases, which come under routine reporting, formats for entering data are available at some places, while at other places, health workers have evolved their own data recording formats. Reporting is done weekly or monthly, but during epidemics reporting is on a daily basis and a nil report is also sent. 9 During epidemics all other activities become secondary to the epidemic work. Health workers often receive the first information about epidemics from the community leaders, local Panchayat members or NGOs working in the area. Some times, they come to know about it through the newspapers. There are rumor registers that are kept in health facilities. In all such situations, the health worker first verifies the information for type of disease outbreak and its location before passing it on to the higher authorities. Health workers are aware of the timings and locations of the potential outbreaks of diarrhoeal diseases, cholera, and malaria. They are more vigilant for such information during the epidemic and a more active search for the cases is done. During the non-epidemic period, only random search for these cases is done. At times local people send telegrams to the collector directly and then the health worker gets the information which is confirmed and reported. Two copies are made and one is sent to the concerned officer and the other is kept for records. At some of the places the data is compiled from three sections: field, health facility based and information from the private practitioners, all reported separately. The data is mostly in form of frequency tables and no further analysis is done at the PHC level. Although most health workers claimed that data was reliable as well as valid, they did agree that it did not represent the whole picture. Many patients seek care from the private sector and are hence left out of the reporting system. There are also areas which are left out during surveillance activities because of being scattered over a large geographical area. Duplication of data is also a possibility due to the same patients being contacted during field visits and subsequently attending the health facilities. In the field, some community members give incomplete or invalid information. The senior officers and health supervisors do not regularly supervise data collection and data recording processes and no feedback is received from them. Reports are either sent directly to the PHC medical officer or to the health inspectors or to the staff nurses at some places. At times the Panchayat members, press and village health committees or local leaders provide information to health authorities in an informal manner, bypassing the health worker. This is particularly true during disease outbreaks. Health workers understand the imperatives of an epidemic and often use the fastest mode of communication as well as break the transmission chain to hasten appropriate action. The district authorities may be informed before the PHC doctors. Occasionally, delays of several days occur in providing information about the epidemic, especially if the health worker is not able to verify the existence of the outbreak or does not give credence to the information received. Some health workers are vary of informing about sudden increases in the number of cases with diseases that have the potential to develop into an epidemic; or report occurrence of unusual cases because of the fear that it would increase their work load. Feedback mechanism for surveillance data is considered less than optimal at present. After the surveillance data is submitted, it travels up through various levels from the PHC to district to state head quarters but no feedback is given to the ground staff about the interpretation and proposed actions. Many times the health workers come to know about the response to data 10 through other channels. Thus most health workers are not sure about the current use of the surveillance data for response, planning and improving health systems. In case of small outbreaks at the local level, health workers along with medical officers at PHC level initiate action without waiting for formal instructions from the district and higher levels. However, if the number of cases is large, outside help in the form of logistic supplies, and additional manpower support is sought. 3.1.2 Constraints perceived by health workers in performing high quality disease surveillance activities Health workers perceived the training to carry out tasks pertaining to disease surveillance as being insufficient. Manuals for some diseases are available in English and most of the health workers are not able to comprehend them. Case definitions are often not clear. When new programs are launched, or modified, case definitions are some times changed, creating confusion among the health staff and also affecting the quality of data collected. The health workers uniformly complained of being asked to collect too much data in the field. This had influenced both the quality of work and ability to complete the task assigned. At places, they were required to fill up 24 registers with every new program adding an additional one. Furthermore, stationary was often not available or adequate thus forcing the workers to use loose sheets, and occasionally purchase the stationery on their own. Health workers make a lot of effort to draw data collection formats on the loose sheets themselves, thus increasing the possibility of filling incomplete as well as inconsistent information particularly when predesigned formats are not available. They often carry loose sheets in the field to avoid carrying all the registers. Priorities of the health authorities are perceived as changing, creating confusion in the minds of the health workers, resulting in poor as well as inconsistent reporting of data. Several patients go directly to the doctors', particularly private practitioners, and thus they are not included in the reporting system. There is inadequate data collection because the population under each worker is too large and several posts are lying vacant. Commuting to the work area is an additional constraint in obtaining complete data. Some times the same information is required to be filled in several places so there is duplication of efforts. Surveillance activities are also hampered during epidemic conditions and when camps were organized. Supervision is not perceived as being supportive and many health workers perceived the supervisory visits as occasions for reprimand leading to loss of confidence. In some places, male and female health workers, voluntary health nurses, and other categories of health personnel complained of being subjected to discriminatory treatment by the department which was demoralizing for their overall performance. It was stated that some people were too shy and embarrassed to talk about diseases related to sex and reproductive organs, particularly if they did not have a good rapport with the health 11 workers. Thus, information related to HIV-AIDS, RTI, and STD were difficult to elicit. Similarly, tuberculosis and leprosy were considered diseases with social stigma. In some places, people consider exanthemata as a curse of GOD and do not let outsiders enter their houses or share the information with health workers. Occasionally mothers would not speak about the illness of their children to health workers because they feared further wrath of evil spirits on their offspring. Religious minority groups in some areas are suspicious of the government health systems and hence withhold information. Urban subjects of higher socio-economic status did not wish to utilize public health services and therefore are not included in reporting of surveillance activities. Due to poor credibility of health systems, many people consider the surveillance activity is meant for the health department with no benefit to common people. Women do not speak freely particularly when the head of the family is not at home or if male health workers approach them for any information. 3.1.3 Gender issues in disease surveillance In FGDs it was found that family elders, in-laws, husbands, sons or the earning members of the family take decisions regarding the place, type and timing of seeking health care. Tribal women and women residing in urban as well as rural areas perceived their education and financial status as important factors in taking independent decisions in matters of health for themselves and their children. Women in both rural and urban areas do not talk about their symptoms either with their family members or with health workers during early the phase of the diseases. They usually first talk to their husbands about their illnesses. Tribal and rural women felt that doctors in public sector health facilities do not provide good care because they are poor. Due to poverty and poor accessibility to health facilities, women first try home remedies. When the symptoms do not ameliorate, help is sought from traditional healers or the local drug store. Thus, it is often quite late when they reach out to existing health facilities for their illnesses. However, for diseases that are perceived as serious in the community, patients are taken to hospital early. If someone inquires about the symptoms and illness, women do not hesitate to share the information, particularly in the tribal areas. Focus group discussions with women in tribal, rural and urban areas consistently brought out the gender disparity to seek health care. When men fall sick, the family gets worried, and treatment is promptly sought. In contrast, attention is not given to the initial symptoms in women. If the symptoms do not subside on their own or with home remedies, then they are taken to health care providers. Women perceived that boys are more delicate and emotional as compared to girls. It was felt by women that girls could withstand the illness better and recover faster, as compared to boys. Interestingly, such perceptions were more prevalent among urban women than among rural or tribal women. 12 3.2 Conclusions from state level workshops The state level workshops in Tamil Nadu, Maharashtra and Uttar Pradesh brought out the following issues on current disease surveillance activities. 3.2.1 Primary level Active or passive data collection is going on for more than 60-90 different conditions in some of the states The peripheral data collection system is over burdened with a substantial percentage of the time of the ANM spent on surveillance related activities Quality of reporting is hampered by absence of clear case definitions Data transmission is affected by poor communication facilities available Absence of formats for reporting diseases adversely affect quality of the data collect. There is no horizontal integration of surveillance activities of existing disease control programs Data is not collected from private practitioners, private laboratories and private hospitals both in rural and urban setting. Infrastructure for urban surveillance is very weak in view of the rapid growth in urban populations There is no system of feedback to the lower levels of the health system. Data collection during emergencies and epidemics is of better quality There is no system of quality control for the data collected and there is very little analysis and action based on the data 3.2.2 District Quality of data collected is poor Analysis of data is inadequate for meaningful interpretation The laid down protocols were not being followed and needed to be activated District level response system is activated only in times of outbreak NCDs not included in surveillance even though the burden due to them is high The information is not shared across disease control programs There is lack of coordination between departments District administrative system not able to make use of the health data 3.2.3 State There is need to improve the quality of data in terms of reliability and validity There is problem of timeliness as data is transmitted to state head quarters irregularly and often late. Most of the data received at the state level is not analysed Data is not used for routine program planning There is need to improve human resources 13 3.2.4 Poor integration and duplication of surveillance activities A number of distinct and independent surveillance activities exist in the states with significant duplication of resources and poor information sharing across stakeholders. Surveillance activities of vertical programs of Malaria, Tuberculosis, Polio, HIV are functioning independently. There is also a pilot project in 100 districts for surveillance of communicable diseases (NPSCD). Few non-governmental agencies are also involved in surveillance. But the overall experience is that the disease surveillance system is not working effectively. It is not able to detect and respond to epidemics, nor is it providing information on important health conditions. There is considerable scope for improvement in many areas and there are certain areas, which are not covered by the present surveillance activities. The main reason why disease surveillance activity in the country perhaps is not as effective as it could be, is because of the following factors: There are a number of parallel systems existing under various programs which are not integrated. The existing programs do not cover non-communicable diseases. There is need to bring the medical colleges and large tertiary hospitals in the private sector into the reporting system as well as for utilization of laboratory facilities. The laboratory network needs to be improved and there is a need to prescribe clear cut thresholds for response at each level. Surveillance is necessary not only for detection of epidemics, but for rapid response to arrest spread of disease and to generate essential data for decision making on a regular basis. Presently, surveillance is sometimes reduced to routine data gathering with sporadic response systems. There is a need for increased use of information technology in order to ensure that information is gathered rapidly and responses made immediately. IT can also be used to analyze and sort data so as to predict epidemics based on trends of the reported of disease so that preventive action can be taken. The consensus is to evolve a system that functions within the existing healthcare system by improving the existing infrastructure and facilities rather than by creating new monoliths; to concentrate on improving human capacity and to focus on utilizing existing facilities for surveillance to the fullest. 3.3 Recommendations based on the above reports 3.3.1 Process of Disease Surveillance Health providers at all levels ought to understand the scope and benefits of disease surveillance and be able to delineate surveillance related activities from other health services. Strategies to improve the validity of surveillance data Increasing the specificity of data 14 There is need to develop operational manuals in the local language for different levels of health functionaries. The health staff should be formally oriented to the contents of the operational manual on surveillance with periodic reinforcement of key issues. The case definitions of the diseases that are under surveillance should be clearly understood by the health workers and other staff. Changes in case definitions should be avoided unless absolutely necessary. Surveillance formats should be simple, requiring minimum necessary information to be obtained and readily available as printed forms. The health workers must complete these during their contact with patients at home, field or health facilities. Increasing the sensitivity of data Complete coverage of population under every health worker by i. Targeting hard to reach and migratory populations ii. Improving efficiency of fieldwork through micro planning and categorizing surveillance data that needs to be collected during house visits or from health facilities. Involving all stakeholders in the entire process (private sector, community, leaders, influences, etc.) by various strategies like social mobilization, sensitization, training and ownership activities. Improvement in the overall quality of data. Surveillance should be restricted to 10-15 health conditions that are of public health significance in the area. Training of health workers and other health personnel in basic principles of epidemiology, data collection, surveillance of health conditions that are now proposed to be included in the list e.g. non - communicable diseases and preliminary data analysis and interpretation. Early identification of outbreaks / epidemics The health workers and field staff should have a pre-defined list of epidemic prone diseases in their area. They must be aware of the epidemiology of these health conditions and risk factors that facilitate disease outbreaks, and maintain a high level of suspicion. Health workers should be able to recognize unknown disease conditions occurring / reported in their area. 15 Awareness levels of traditional sources of first information about epidemics (i.e. community members, local leaders, press, NGOs) should be increased to facilitate early reporting. Interval between first information and confirmation of outbreak needs to be minimized to avoid delays in response. Health staff should be encouraged to report occurrences of unusual cases or observed increase in the number of cases with epidemic potential. Trigger levels and standard operating procedures need to be pre defined for all health conditions with epidemic potential. Disease Surveillance has to be associated with feedback to field staff and community and appropriate responses. There is a need for an inbuilt mechanism of regular monitoring of the program with a checklist of tasks that ought to be supervised. Supervision has to be supportive. PHC doctors should perform their role as leaders of the primary health care team by providing appropriate training, motivation and encouragement, to health workers. 3.3.2 Involvement of Private Sector The objective of incorporating the private sector in health will be to improve the sensitivity of surveillance data. The private health facilities / practitioners including traditional healers can function as sentinel sites to regularly collect and send information on a very restricted number of health conditions. Such information will at least be able to demonstrate the trends in disease occurrence. The process of involving private sector requires some experimentation. Some of the strategies suggested by health workers during FGDs are: - to create awareness about disease surveillance and its benefits. to provide them training for carrying out surveillance related activities. legislation may also prove to be effective in their involvement. 3.3.3 Community involvement An institutional mechanism to be put in place where field staff makes proactive efforts to develop personal rapport with the community and solicit their support and cooperation in various health programs including disease surveillance. Community must be regularly given feedback about surveillance data and the consequent responses to sustain their participation and interest. Community leaders, influencers and NGOs should also be made part of the process that makes health related decisions at the community level. 16 3.3.4 Social Mobilization Different IEC and social mobilization campaign strategy for - 4 health personnel and private practitioners; and community, community leaders and NGOs IEC messages have to be prepared within the local context and in a locally comprehensible language. All channels of communication to be used for creating awareness. Social mobilization campaigns must address the prevalent socio-cultural beliefs and issues relating to gender disparities. EVOLUTION OF IDSP IN INDIA In 1998 the Government of India requested the World Bank to support preparation of a disease surveillance project. During subsequent discussions, the Bank and the GOI agreed to collaborate on preparing a disease surveillance project, which will have the following characteristics: 4.1 The program will cover a limited number of disease conditions of public health importance, in which public health response is needed. It will cover both communicable and non-communicable diseases. The system will use different methods of surveillance (e.g. sentinel sites, periodic surveys etc. in addition to the regular surveillance). The program will be action oriented with the ability of timely response at the local and regional level, in addition to national level responses. It will integrate all existing surveillance activities of the disease control programs. The program will envisage the use of modern Information Technology to facilitate transfer of information. The program will be decentralized and state based in its administrative structure. The center will be responsible for co-ordination, quality control, policy formulation, financial and technical assistance. There will be an overall emphasis on monitoring system performance, evolution and change, and on building capacity at all levels. Development of project implementation plan The project preparation commenced with a meeting at Hyderabad in September 2000, in which four states and the GOI were present together with representatives of WHO, CDC, NIH, USAID, DFID and other national agencies like NICD and ICMR. In this meeting a consensus on the above project plans was reached. Following this meeting the MOHFW set up a steering committee chaired by the Special Secretary, (Health) and six members from NICD, ICMR, WB were selected to oversee the progress of this project. 17 MOHFW, GOI requested Tamil Nadu, Maharashtra and Uttar Pradesh and later Andhra Pradesh, Karnataka, Himachal Pradesh to prepare the state Project Implementation Plan for the project. INDIACLEN consultants were contracted to help the state governments in the preparation of the PIPs in the three states. 4.2 Developing consensus on IDSP in participating states Health is a state subject in the federal constitution and is administered by the state governments with guidance from MOHFW, Government of India. The states have initiated a number of health programs to improve the health of the people. The vertical disease control programs administered by the central government are also mediated through the state health systems. Most of these programs have been only partially successful in their delivery because of the wide variation in socio-cultural differences and health infrastructure. In this setting it is not possible to adopt a common surveillance system for the whole country and there is need to understand and adapt to differences in the region. Therefore, it was considered important to have a grass root level approach to the development of IDSP in India. Three state level workshops were conducted in Tamil Nadu, Maharashtra and Uttar Pradesh to facilitate state PIP development. The objective of the workshops was to understand the current surveillance activities of the state with a view 1) to improving the quality of disease surveillance activities and 2). To identify priority diseases which require surveillance, based on the burden of disease and availability of public health action. These meetings were organized primarily by the Director of public health in the three states with collaboration from MOHFW GOI, USAID, WB and INDIACLEN. A bottoms up approach was used and state level meetings included grass root level workers from PHCs, Block and District level administrative officers, representatives of Indian Medical Associations and other NGOs doing surveillance, in addition to state level program officers, state health secretary, Director of public health. Currently State PIPs have been obtained from two states, Tamil Nadu, Andhra Pradesh, Karnataka, and Maharashtra. In addition, state level workshops and situational analysis and assessment of current needs were additionally performed in Uttar Pradesh. The government has corresponded with state administrations on the concept plan of IDSP and obtained feed back from six states and three union territories: 1) Haryana, 2) Arunachal Pradesh, 3) Karnataka, 4) Goa 5) Gujarat 6) Uttaranchal, 7) Union territories of Lakshadeep, Dadra and Nagar Haveli, Pondichery. They have committed to implement IDSP. A national level PIP draft was prepared, based on the above information. This was circulated to at least eight other states (West Bengal, Manipur, Madhya Pradesh, Uttaranchal, Andra Pradesh, Karnataka, Goa, and Pondichery) to further understand the basic differences, particularly on infrastructural differences in quality and types of laboratory networks. Available human resources, capacity for undertaking training for the program and differences in administrative structures in the states were taken into account in the preparation of the final document. 18 4.3 National workshop In June 2001, a National level workshop was conducted in New Delhi to reach a consensus on the role of central agencies. This meeting was organized by the MOHFW, GOI in which the conceptual framework for the Integrated Disease Surveillance (IDS) Program was discussed with partner agencies. Responsibilities of partners were discussed to develop a surveillance system in the country without delay, which is: 5 Integrated Decentralized Action oriented Responsive IMPLEMENTATION STRATEGY TABLE : RESPONSIBILITIES AND ACTIVITIES OF STAKE HOLDERS: ANM Serial No: Activity Disease/Risk factors 1 Data Collection 1) Malaria 2) TB 3) ADD 4) Typhoid 5) EPI - Fever with Rash 6) Jaundice 7) AFP 8) Other Rare disease a) Meningitis b) Tetanus c) Whooping Caugh d) Plague e) Anthrax f) Death unknown cause g) Suicides 9) Water Quality 10) Road Traffic Accidents 11) 12) 13) 14) 15) 16) MHW MO_PHC Community/ Village SSPs Pradhan/Media District *** *** *** *** *** *** *** *** *** *** Medical Colleges State * 7 8 9 10 Training Monitoring & Evaluation Policy & Guidelines Consultancy TOTAL *** ** *** *** ** * *** * *** ** *** *** *** * * * * * * *** ** * *** *** *** *** *** *** *** *** *** Urban Data Lab confirmation of diagnosis Internal Quality control Epidemic Investigations Analysis, Dissemination & Reporting External Quality control Partners ** ** ** ** ** ** ** CVD Risk Factors HIV/AIDS STDS/RTI Other Risk behaviour Air Pollution AMR 2 3 4 5 6 Center * * *** * * *** * *** *** *** *** *** *** ** * ** ** *** ** ** 6 5 4 9 *** 8 ** ** 9 7 14 *** ** ** *** 8 5 The variations in health infrastructure in the participating states require that the IDSP program be implemented, using a modular strategy in a phased manner. The four main components of IDSP in terms of resource allocation are: 1) Information Technology and Networking 2) Laboratory Upgradation 3) Human Resource Development 4) Disease surveillance and response mechanisms. 19 It is envisaged that the states will be utilizing funds differentially on different key components of the program to achieve IDSP objectives. External evaluation of the program will be undertaken at the end of the second year and fourth year, to assess the progress in the process of implementation and the result of this evaluation will determine the type of support provided for the next phase of implementation of IDSP in a given state. By the end of the first year it is expected to bring at least 10 states with ‘Political Will’ into the program. The states will be included in the program as and when the state PIPs are completed during year two and by the end of the second year, it is expected that all the states in India will be inducted into the program at a basic level. The detailed time line is given in section 32. The ability of Medical colleges to perform the functions specified under IDSP will be ensured by the Government by initiating appropriate consultations with the state health administration and Medical Council of India. The participation of private practitioners is crucial in detecting trends of disease and for early detection of emerging diseases since, more than 70% of the health care is being carried out by non-governmental agencies. Sentinel Private Practitioners and Hospitals will be integrated in the program. The recruitment of sentinel private practitioners will be undertaken in a phased manner with doubling of the number of private practitioners in the second year of the program. This will be facilitated by establishing formal linkages with Indian Medical Associations and other relevant national professional bodies of medical practitioners. The state and district surveillance officers will be primarily responsible for this activity. The participation of all private laboratories will be mandated with legislation and accreditation. Registration of these entities with the authorized State / National accreditation bodies will occur after the legislation is passed. 6 SPECIAL ASSESSMENT CARRIED OUT FOR IDSP 1. 2. 3. 4. 5. 6. 7. 8. 7 Assessments Laboratory Needs for IDSP Information Technology assessment Determinants of Quality in Data collection Institutional Assessment Economic Assessment Training Assessment Environmental Assessment Social Assessment Agencies - CDC / WB / INDIACLEN - World Bank/Deptt. of IT - INDIACLEN / WB - World Bank - World Bank - WHO / INDIACLEN / WB - World Bank - World Bank PROGRAM SUSTAINABILITY The IDSP will be completely funded in the first five years. Thereafter, the important heads under which costs are likely to be incurred on a recurring basis are: Information technology and communications, laboratory and training. It is estimated that approximately 10% of the project costs are required to sustain these components. No additional expenditure on personnel and infrastructure are envisaged for the proposed IDSP. Furthermore, the current expenditure on surveillance components of several vertical programs will also be available for IDSP. 20 PART – II OBJECTIVES AND COMPONENTS 21 8 OBJECTIVES OF INTEGRATED DISEASE SURVEILLANCE The project development objective is to improve the information available to the government health services and private health care providers on a set of high-priority diseases and risk factors, with a view to improving the on-the-ground responses to such diseases and risk factors. Specifically, the projects aims: To establish a decentralized state based system of surveillance for communicable and non-communicable diseases, so that timely and effective public health actions can be initiated in response to health challenges in the country at the state and national level. To improve the efficiency of the existing surveillance activities of disease control programs and facilitate sharing of relevant information with the health administration, community and other stakeholders so as to detect disease trends over time and evaluate control strategies. The project will assist the Government of India and the states and territories to: surveil a limited number of health conditions and risk factors; strengthen data quality, analysis and links to action; improve laboratory support; train stakeholders in disease surveillance and action; coordinate and decentralize surveillance activities; integrate disease surveillance at the state and district levels, and involve communities and other stakeholders, particularly the private sector. 9 COMPONENTS OF PROPOSED IDSP Project Component 1 Establish and Operate a Central-level Disease Surveillance Unit Under this component, MOHFW will establish a disease surveillance unit at the central level. The new unit will support and complement the states' disease surveillance efforts. The unit will be staffed by 7 permanent staff reassigned from within the MOHFW. In addition, 15 contract staff (5 technical and 10 support staff) will be hired. Government orders for establishing the unit have already been issued and the positions for contract staff have been advertised. Suitable office space has been identified and communications and information technology equipment and furniture are included in the budget. The permanent and contract staff will be responsible for the activities of the unit which will include: preparation of national guidelines for disease surveillance based on agreement with the states and other stakeholders on the priority diseases and conditions to be included in the surveillance system, standardized case definitions and the methods to be used for their surveillance. promoting compliance by the states with central policies and technical guidelines. 22 providing overall support to states and coordinating national surveillance activities, including the preparation of a national plan of action. coordination and timely transport of specimens to the regional, national and international reference laboratories. data analysis to identify epidemiological trends and preparation of national reports on the epidemiological situation. coordination of Quality Assurance surveys (in conjunction with the states). The project will finance consultants, equipment and furniture and incremental operating costs. Project Component 2 Integrate and strengthen disease surveillance at the state and district levels This component includes involvement of communities and other stakeholders, in particular the private sector. This component addresses the constraints imposed by lack of coordination at the sub-national levels, the limited use of modern technology and data management techniques, the inability of the system to act on information and the need for inclusion of other stakeholders. It will consist of 4 sub-components: (a) State-level. A disease surveillance unit will be established at the state level under the project. The State Surveillance Unit (SSU) will be headed by a technical officer from the state cadre. The state office will also hire 3 technical consultants and 4 support staff. Emphasis will be on strengthening integration of the activities of existing health staff, laboratory information, the private sector and the community into the overall system through implementation of procedures and activities spelt out in the district-level and state-level disease surveillance manuals. Activities at the state level will include: preparing and sending monthly summaries of the disease situation to the central level; training state and district level staff; implementing periodic surveys for non-communicable diseases and/or their risk factors; implementing Quality Assurance surveys (in conjunction with GOI); integration of disease control efforts based on the surveillance data; supporting districts in data analysis, transport of laboratory specimens, and outbreak investigations; analyzing surveillance data across districts. (b) District level. The District Surveillance Unit (DSU), established under the project, will be headed by a medical graduate with a background in public health and/or epidemiology. Other contract staff will include a microbiologist and 4 support staff, including data entry operators. Activities will include: analyzing surveillance data from the peripheral level; providing support for collection and transport of specimens to laboratory networks; initiating investigation of suspected cases; 23 providing feedback to the health facility; responding promptly to information provided by communities. (c) Community level: Activities will include: notifying the nearest health facility of a disease or health condition selected for community-based surveillance supporting health workers during case or outbreak investigations using feedback from health workers to take action, including health education and coordination of community participation. (d) Strengthen data quality, analysis and links to action: Activities will include: 'real-time' on-line entry, management and analysis of surveillance data through use of computers, the Internet and the WWW; reporting surveillance data using standard software, including GIS, while allowing flexibility to add new systems as needed; email services between central sections and departments, within and between states, laboratories and other persons and institutions involved in public health; rapid dissemination of 'health alerts' and other textual information; and electronic distribution of reports both to the public health staff and civil society; Quality Assurance surveys of laboratory information. The Information Technology aspects of the project will involve setting up a network to transfer data between various levels of the system, provision of stand alone computers at the district level and links to district, state and national units. Software for the system will be developed to facilitate simplified data entry with multilingual formats, analysis and consolidation of data at each level, generation of alerts on the basis of disease-specific thresholds, documentation of the system and development of manuals, phased deployment of software, skills assessment of staff and provision of appropriate training. Further details of the Information Technology element of the project are given in Annex 11. The project will support incremental operating costs, purchase of services from NGOs, consultants, computers, development and purchase of software, technical assistance, strengthening of electronic communication between the districts, states and center, IEC materials and media space. Project Component 3 Improve Laboratory Support. This component would consist of: (i) The upgrading of laboratories at the state level, in order to improve laboratory support for surveillance activities. Adequate laboratory support is essential for providing on-time and reliable confirmation of suspected cases; monitoring drug resistance; and monitoring changes in disease agents; and 24 (ii) The introduction of a quality assurance system for assessing and improving the quality of laboratory data. The laboratory network for the IDSP will have 4 levels: L1 - peripheral laboratories and microscopy centers; L2 - district public health laboratories; L3 - disease-based state laboratories; and L4 – reference laboratories and quality control laboratories. L1 laboratories will provide information for the diagnosis of malaria, TB, typhoid, chlorination levels in water and fecal contamination of water. Whilst these laboratories already handle examination of sputum and blood smears, some need minor internal modification as well as the provision of kits for typhoid diagnosis and assessment of fecal contamination of water. L2 laboratories will need to carry out tests for TB, malaria, typhoid, cholera and water quality, primarily to confirm results from the peripheral levels and for quality control. Some will require minor internal modification and additional equipment, reagents and kits. These laboratories will also be connected to the computer network. Staff will be as already assigned, reassigned from other laboratories or, in the case of microbiologists, hired on contract. L3 laboratories will carry out tests to confirm L1 and L2 results, for some state-specific diseases (e.g. leptospirosis), as part of the internal quality control mechanism, and assays required for the non-communicable disease surveys. The project provides for some minor internal modification of laboratories, equipment required for additional tests, reagents and kits, and a computer, software and telephone connectivity. L4 laboratories - IDSP will have one central and four reference laboratories to support routine work and specific outbreak investigations. These are high quality laboratories which already have the capacity to carry out the laboratory tests required. The project will fund incremental operating costs and, if required, a computer, software and telephone connectivity. External Quality Assurance surveys (EQAS) of laboratory data are an important tool in improving the quality of laboratory information. This will be carried out under contract to a third partner with external accreditation for medical laboratory quality assurance. Standard material will be supplied or the assay and assessment to a sample of IDSP laboratories in each state each year. These results will then form the basis for specific interventions in the IDSP system to improve laboratory quality. The Terms of Reference for these surveys are set out in Annex.13. The component would finance renovation of existing buildings, purchase of equipment, technical assistance, incremental operating costs and surveys. Project Component 4 Training for Disease Surveillance and Action The changes envisaged under the first three components will require a large and coordinated training effort to reorient health staff to an integrated surveillance system and provide the new skills needed. This component will support general training for orientation of staff in both the public and private sectors to disease 25 surveillance; specific training for disease control staff; specialized training in epidemiology; specialized training in data management and communications. The training strategy and plan for the project is based on training needs assessment carried out in 6 states. Eight separate short-term training programs for various categories of staff are to be covered in the training program. The material to be covered for each group and the numbers to be trained are shown in the table below: Trainees I Training of central, district and state surveillance teams II Medical Officers ofthePHCs, CHCs and Urban Health sector. MOs of local Medical colleges. Mos of NGOs/ Mission Hospitals III Medical Officers of the Hospitals, Sub-district Hospitals, Medical College Hospitals IV MPWs (Male / Female), Health Supervisors, NGO volunteers, unregistered Medical practitioners Content of Training Number to be trained • Overview and introduction to surveillance with special reference to IDSP. • Basic epidemiology pertaining to surveillance including definitions like rates, ratios, Incidence Rate, Prevalence Rate, spot maps, graphs etc. • Details of case detection, including case definitions, reporting units and filling up forms, compilation and transmission of data • Collection and transmission of laboratory specimens and bio-safety issues • Details of analysis and interpretation of data • Details on response to outbreaks • Supervision Monitoring and Evaluation . • Feedback • Training methodology • Inter-sectoral coordination • Cluster survey sampling and analysis methods (state team only) • Overview and introduction to surveillance with special reference to IDSP. • Details of case detection, including case definitions, reporting units and filling up forms, compilation and transmission of data • Collection and transmission of laboratory specimens and bio-safety issues • Basics of analysis and interpretation of data • Details on response to outbreaks • Supervision Monitoring and Evaluation. • Overview and introduction to surveillance with special reference to IDSP. • Details of case detection, including case definitions, reporting units and filling up forms, compilation and transmission of data • Basics of lab confirmation - what specimens to be sent to which lab, and in what manner for confirmation • Overview and introduction to surveillance • Syndrome description • Filling up of forms • Transmission of data • Collection of specimens • Biosafety issues • Basic response to outbreaks 2523 19298 6900 160153 26 • Overview and introduction to surveillance with special reference to IDSP • Hands on training on diagnosis of specific diseases. Especially culture and sensitivity of stool and blood, serology etc. • Quality assurance mechanisms • Biosafety issues V State and District level microbiologists / lab technicians. Also of the urban health sector. Also Microbiologists from local Medical Colleges VI Training for lab • Introduction to IDSP assistants at CHC • Testing for sputum AFB, Malarial smear, Typhoid /PHC test Collection, Storage and transportation of specimens Biosafety issues Training for data Introduction to IDSP management at Extracting of data from the computers district and states Analysis of data level VII 2368 3356 592 10 DISEASES TO BE INCLUDED IN THE SURVEILLANCE PROJECT The diseases to be included in the surveillance program will be based on the following criteria: 1) Burden of disease in the community, 2) Availability of public health response and 3) Special considerations and international commitments. Based on the information obtained from the state level workshops the following core conditions will be included in the IDS program. The disease conditions that are included in the core list and state specific list of the surveillance program will be reviewed once in two years based on disease burden and availability of public health action and suitably modified. 10.1 List of Core Diseases: Regular Surveillance: Vector Borne Disease Water Borne Disease Respiratory Diseases Vaccine Preventable Diseases Diseases under eradication Other Conditions : 1. : 2. : 3. : 4. : 5. : 6. : 7. Malaria Acute Diarrhoeal Disease (Cholera) Typhoid Tuberculosis Measles Polio Road Traffic Accidents (Linkup with police computers) 27 Other International commitments: Unusual clinical syndromes (Causing death / hospitalization) : 8. : 9. Plague Menigoencephalitis / Respiratory Distress Hemorragic fevers, other undiagnosed conditions Sentinel Surveillance Sexually transmitted diseases/Blood borne : 10 Other Conditions : 11 12 HIV/HBV, HCV Water Quality Outdoor Air Quality (Large Urban centers) Regular periodic surveys: NCD Risk Factors : 13 Anthropometry, Physical Activity, Blood pressure, Tobacco, Nutrition, Blindness and any other unusual health condition GOI may include in a public health emergency - subject to agreement at the next joint project review mission, project funds could be used for these surveillance activities). 10.2 Additional State Priorities In addition to the core diseases which will be under surveillance for all the states, each state will be able to identify up to five additional conditions for which surveillance will be initiated. State Specific Diseases for States covered in Phase I are given below : Andhra Pradesh Karnataka Kerala Tamilnadu Maharashtra M.P. Uttaranchal Mizoram H.P. Filariasis Filariasis, KFD & HGS, Leptospirosis Leptospirosis Leprosy,Leptospirosis Diphtheria, NN Tetanus, Leptospirosis Leprosy, Diphtheria, NN Tetanus Leprosy, Diphtheria, Tetanus Cancer, Substance Abuse, Acid Peptic Disease, Pneumonia Thyroid Diseases, Leishmaniasis, Acid Peptic Diseases, Rheumatic Heart Diseases, Cancer Note: In the event of a public health emergency, this list may be expanded to provide the necessary surveillance and rapid response by MOHFW and States. The inclusion of such disease and its surveillance and rapid response activities under the Project would be reviewed by the subsequent Joint Review Mission (JRM). Such activities would be eligible for IDA financing until the subsequent JRM. The financing of such activities by IDA beyond the Joint Review would depend on the recommendations of the JRM. 28 11 METHODS OF SURVEILLANCE Quality of data collection is of crucial importance. Hence, overloading the peripheral health worker will be avoided. The following three main sources of data will be tapped within the system for collection of surveillance data. Routine reporting will be conducted at the PHC by the ANMs and HWs. State specific diseases will be added to this, to a total of not more than 15 disease conditions including the state list. Information related to geographical changes in prevalence can be obtained by the system by sentinel surveillance. This form of surveillance will be used for HIV, HBV, HCV, Water Quality, Air Quality etc. Special teams will be developed to assess NCD risk factor surveillance. The below specifies the details and type of surveillance for various diseases identified in the above list TABLE : FREQUENCY, RESPONSIBILITY AND TYPE OF REPORTING Disease Conditions 1 2. 3. Tuberculosis Malaria Cholera Unit Surveillance Method Recording PHC SPPs/PH DH Regular Micro C P-Lab DPHLab PHC SPPs/PH DH Micro C Regular Passive Active and Passive Daily Weekly Daily Daily Weekly Daily Daily by HW Weekly Daily Daily P-Lab DPHLab Other Weekly Daily Weekly PHC Daily by HW Weekly Weekly Daily Daily PHC Regular SPPs/PH DH DPHLab Passive Confirming/ Reporting Weekly MO Weekly Weekly DTO Weekly DTO Weekly Weekly LD Weekly MO Weekly Weekly DMO Weekly (ADPH) Weekly Weekly LD Weekly MO/DMO Weekly MO Weekly MO Weekly Weekly DMO Weekly LD Lab Confirmation Peripheral Lab Peripheral Lab Peripheral Lab 29 Other Disease Conditions 4. 5. Typhoid Measles Unit Weekly Surveillance Method Recording PHC SPPs/PH P-Lab Regular DH DPH Lab Passive PHC Active PHC Regular SPPs/PH DH Other Passive PHC Active Passive DH 6. Polio Regular Passive SPPs/PH Other 7. Unusual clinical syndromes / Diseases with international commitments PHC PHC DH Other Active Regular Passive Weekly MO/DMO Confirming/ Reporting Weekly Weekly Weekly Daily Daily Weekly MO Weekly Weekly Weekly DMO Weekly LD Daily by HW Weekly Weekly Daily Weekly Weekly by MO Daily Follow current system) Follow current system Follow current system Weekly Weekly MO Weekly MO Daily Weekly Daily Weekly Weekly DMO Weekly DMO Weekly DMO Weekly Weekly by MO Weekly Weekly DMO Weekly MO/DMO Weekly DMO Lab Confirmation Peripheral Lab and District Lab District Laboratory State and Reference Labs Weekly DMO Weekly Peripheral, District and State Labs 30 8 State Specific Diseases (Refer Section 10.2 for Details) Disease Conditions 9 Road Traffic Accident 10 HIV – ANC data Water 11. Quality 12. Out door Air pollution 13. NCD Risk Factors PHC Unit S.Police SACS PHC WB PCB DSO Regular Passive Daily HW by Surveillance Method Recording Regular Sentinel Confirming/ Reporting - Weekly Active Once in a Once in 3 month months Monthly Monthly MO Monthly Monthly DSO Twice Twice weekly weekly Once in 1 1 Years DSO year Sentinel Active Active Active Sentinel Active Sentinel Weekly by MO District and State Labs Lab Confirmation Weekly NA District Lab Peripheral and District Labs State Lab State Lab 12 SURVEILLANCE OF RISK FACTORS FOR NON COMMUNICABLE DISEASE AND THEIR RISK FACTOR 12.1 Aims• Assessing prevalence of CVD risk factors, among various populations so as to monitor trends in population health behaviors and risk factors for chronic disease over time. Determine the need for chronic disease prevention and control programs in the community. Determine financial allocation for programs in controlling NCDs in the community. It is proposed to measure the following, as the first stage of NCD surveillance in the IDSP program: Demography Tobacco and Alcohol use Pulse rate Blood pressure Height and weight Waist measurement Physical activity index Pattern of nutrition. 31 As the second stage, the measurement of Hb, Cholesterol and HDL / LDL ratios, Blood glucose may be taken up on a random sample of subjects in coordination with the state surveillance laboratory. FIG. STEP WISE METHOD IN NCD RISK FACTOR SURVEILLANCE IN IDSP: Step-wide Approach to Risk Factor Surveillance Biochemical es Tr ig ex ici ty lyc er id measures Co m pl Fasting blood glucose m Ti ed k, w Blood Pressure sk al s es ai BMI iv ity W s t/ H ip BP KA g n pi co str d Physical measures Reported Comprehensive l ica ed M , t e Di ry sto Expanded hi Demography P BM hys i I cal Ac t Tobacco Alcohol l fo in Cost Cholesterol Core 12.2 Method A Proportionate to Population Cluster Survey will be conducted in 20% of the districts every year on a regular basis. This would ensure full coverage in five years time and provide information on a yearly basis. Health delivery clusters will be selected on a stratified random basis in urban and rural sectors, so that information is available on high-risk populations in the urban areas and targeted interventions can be initiated as necessary. Regular surveys will be carried out under the directions of the state Director of Public Health. The design of the survey will be made in collaboration with ICMR. Manual of procedures will be made available to the investigating team. The NCD surveillance team will be contracted to an organization who has previous experience in conducting public health surveys. Training will be provided to the NCD survey team in collaboration with ICMR and State Medical Colleges. External quality assurance for the program will be the responsibility of ICMR. Since the same team will be doing surveillance for 20% of the district each year, the learning curve and feed back from monitoring and evaluation will provide necessary inputs to improve their quality of work as the program evolves. 32 12.3 Logistics It is proposed that on a yearly basis the survey will be contracted out to the best bidders for this program who will be able to deliver the results in the stipulated time of 1-2 months to cover 20% of the geographical area. Money will be allocated for this under IDSP. The NCD Risk factor surveillance manual will be developed by ICMR and the State NCD team will be trained within six months of the IDSP, so that NCD surveillance can start by the first half of 2003. Retrospective financing may need to be arranged for NCD team training. 33 PART – III SURVEILLANCE MECHANISMS 34 13 REPORTING UNITS 13.1 Rural a. Medical Officer Block PHC (BPHC / CHC –100,000) i Sub-centers ii PHC (30,000) iii CHC (100,000) b. Sentinel Private Practitioners c. Informers at community level (Rumor registry) i. Village Pradhan ii. Teachers iii. Anganwadi members iv. Self help group v. News papers 13.2 Urban a. Hospital b. Medical Colleges c. Sentinel Private Practitioners/ Sentinel Private Hospitals/Private Lab d. Specialty Hospitals: i. Infectious disease ii. Tuberculosis iii. Children e. Municipal Corporation i. Hospitals ii. Dispensaries / Health Posts f. Employees State Insurance Scheme (ESI) i. Hospitals ii . Dispensaries g. Central Government Health Scheme i. Hospitals ii. Dispensaries h. Railways i. Hospitals ii. Dispensaries i. Informers at the community level (Rumor registry) i. Ward members ii. Anganwadi workers iii. Youth groups iv. News papers 13.3 Special Units a. Other NGOs doing surveillance activities b. State Water Pollution Control Board c. Regional/ State Air Pollution Control Board d. District Police Information System 35 STRUCTURAL FRAMEWORK OF INTEGRATED DISEASE SURVEILLANCE PROJECT RURAL SURVEILLANCE CSU- Central Surveillance Unit SSU- State Surveillance Unit DSU- District Surveillance Unit CSU UUu UUS UUU UU URBAN SURVEILLANCE SSPS - Selected Sentinel Private Sites SSU District/HIV/AIDS Rural SSPS - 15 District TB Lab District Hospital PHC , Sub-centres Informers ID Hospitals Dispensaries Informers DSU UU ESI Railway Hosp Water Dept. CGHS Corporation Hosp Pollution Control ICMR Labs Rural Medical Colleges Police District Malaria Unit 36 Medical Colleges Urban SSPS-15 14 STRUCTURAL FRAMEWORK OF IDSP Consistent with the philosophy of IDSP and to meet its objectives, the focal point of all surveillance related activities at the periphery will be the District Surveillance Unit (DSU). DSU will receive surveillance data from both rural and urban reporting units. To increase the sensitivity of data, additional reporting will be identified in both urban and rural areas. It will be particularly critical for urban areas where current surveillance efforts are grossly inadequate. For the first time private sentinel sites from both urban and rural areas will be identified as partners. Further, in urban regions ESI, Railway Hospitals and Dispensaries, Medical Colleges, Private Hospitals, Army Hospitals will also contribute to urban surveillance. Information on Road Traffic Accidents will be obtained from the police department. Analysis, response and feedback from these sources will be coordinated by the DSU. DSU will be in communication with the state and central surveillance units through the district surveillance network in vertical integration. At the periphery, public sector reporting units especially, the CHCs will be directly entering data through the computer network supplied as part of the program. If facilities are available the sentinel private practitioners and other reporting units will directly transfer data to these units. Alternatively, data entry operators will need to input approximately 40 reports per week from rural and urban sentinel sites at the DSU. 14.1 Urban surveillance Census 2001 shows that there are 31 cities with more than 10 lacks population in the country. Of these 3 are Mega Cities (Metros) with more than 8 million population and 3 Large cities with 4-8 million population. The distribution of these cities is given in the Map attached. The urban disease surveillance system is weak with poor infrastructural support and over load of existing staff in most urban setting. There is also wide variability in the administrative structure of these corporations. Currently surveillance is weak and the program involves only the government sector. The IDSP envisages integrating all available resources with emphasis on private practitioners, Private hospitals and laboratories and medical colleges wherever available as described under sections 15 and 16. Thus the thrust of the IDSP in urban surveillance will be through Sentinel hospitals, Medical colleges and Sentinel Private Practitioners. It is proposed that for every 20 lacks-40 lacks (2-4 million) population infrastructure will be provided to undertake district level surveillance activities. Thus metro cities of Delhi, Mumbai & Culcutta will have 3 district level infrastructure while large cities like Chennai, Bangalore and Hyderabad will have 2 district level infrastructure each. Smaller corporations 1-4 million will be considered as one health district. Corporations having smaller than 1 million population will 37 report to the district surveillance unit of the district head quarters along with rural sites of that district. Each urban district will have 15 sentinel surveillance units / 10 lack population. including government and private sector reporting to the urban district surveillance officer (DSO). The number of sites may be doubled over the next 1 year. This will be further linked to the state level surveillance unit as with other district surveillance units. Number of Mega Cities with more than 8 million Population Number of Very Large Cities with 4-8 million Population Number of Large Cities with 2-4 million Population Number of Moderately large Cities 1-2 million Population = 3 Sentinel sites = 3 x 8 x 15 = 3 “ = 3 x 4 x 15 = 4 “ = 4 x 2 x 15 = 21 “ = 21x1 x 15 = 360 = 180 = 120 = 315 Details of the flow of information will vary with the administrative structure of the urban health system in 38 each situation. The overall framework has been specified above. Thus for urban surveillance in the country there will be approximately 1000 sentinel units of which 500 will be from the government sector (District hospital, ESI, Railway, Medical colleges etc) and 500 will be private sentinel sites (Private hospitals, Private laboratories, Private practitioners, Private medical colleges etc). The sentinel sites under government sector will undertake outbreak investigations and other preventive action in response to surveillance information. The private sentinel sites will be largely data gathering sites to increase the sensitiveness of the system to changing trends. 15 INTEGRATING PRIVATE PRACTITIONERS IN SURVEILLANCE More than 70% of primary health delivery in our country is by private health providers (Private Practitioners - PPs) of traditional or modern medicine. Valid and timely information on disease patterns can be collected only if they are integrated into the Disease Surveillance Program. It is logistically difficult to include all PPs and maintain the quality of data collection. Therefore it is proposed to have selected Sentinel Private Practitioners (SPPs) to be part of the program so as to detect trends of disease and identify the occurrence of outbreaks, early. Objectives: To identify disease outbreaks early To find out trends of disease over a period of time 15.1 Identification and selection of sentinel private practitioners (SSPPS) The district surveillance officer will be responsible for integrating SSPs in each district. The selection criteria will be: Willingness to participate in the program. SPPs who are likely to come across a large number of cases of the disease of interest. Previous experience with collaboration on health programs with the Public Health System. The private sector has been effectively involved with AFP surveillance by the NPSP, as reporting units. Involving ~20,000 private sites across the country, and ensuring their sustained interest as well as participation will be very challenging. A partnership of this magnitude between the public and private sector has not been experimented with before in the health sector. 15.2 Recruitment of Private Practitioners to be Sentinel Sites in IDSP Specific steps required to be taken by the district surveillance officer to facilitate private participation include: 39 a. Approaching the private practitioner through professional bodies like IMA, IAP, API, ASI etc. b. Organizing surveillance workshops at state and district levels to disseminate objectives, methods and outcome of proposed IDSP. c. Establishing direct dialogue with potential private sentinel sites. d. Motivating participation through incentives such as: Inclusion of name in the network directory. Certificate of recognition and participation under IDSP. Access to IDSP computer web reports. Quarterly bulletins on health status of the region from District Surveillance Officer. Feedback from health workers during regular visits to collect data. Membership in village health committee meetings on rotatory basis. The most important incentive will be the regular feedback offered to them. Those who have access to computers may access the Web database of the IDSP and hence get regular reports on disease patterns. This will also allow them to see who has reported what diseases in the last quarter. The name included in the data base will act as an incentive. Printed quarterly reports will be sent to all participating SPPs from the district surveillance unit. This bulletin will list all the SPPs who are contributing to the program in the district and the number of cases reported by them in each quarter. A written memorandum of understanding will be made with participating SSPs in each district. 15.3 Sentinel private laboratory sites These will serve as another category of urban reporting units. At least 10 urban private laboratories per district including the district hospital will be included. If and when the accreditation process becomes operational, then all accredited laboratories will be included. Till then, the process of selection would be similar to the one under SSPs. 15.4 Number of private sentinel reporting sites It is proposed that each surveillance unit at the block level have at least one sentinel private practitioner / Sentinel Private Hospital site reporting regularly on specified diseases under IDSP. There are approximately 15 blocks per district. Thus there will be ~9000 rural sentinel sites. Similarly, in the urban area of each district there will another 15 SSPs / SPH sites per district total of about ~9000 urban sites. In large metros there will be at least 20 sentinel sites selected and distributed throughout the urban surveillance unit in the city / municipal limits. Large cities in the country with a population of more than 2 million which will be considered metros. These cities will contribute another 500 additional sentinel sites bringing the total of SSPs / SPHs to ~ 20,000 in the country with 650 districts. This would also ensure that at the district level we will be entering data from 10 CHCs and 30 SSPs, a total of 40 per district. 40 15.5 Phased Induction There will be a phased increase in the induction of SSPs in the program. In the second year, the total number of SSPs will be increased from 15 to 30 per rural and urban region of the blocks and 40 SSPs from large metropolis cities. This will bring ~20,000 urban and ~20,000 rural SSPs contributing to the IDSP by year three. 15.6 Facilitating reporting by private sentinel sites 15.6.1 Simplified Formats As this is an attempt to see the disease pattern and not actually the disease burden, the format would contain limited information like diagnosis, age, sex and residence only. 15.6.2 Frequency of Reporting It is suggested that each of the SPPs report at weekly intervals. Since at each PHC there will be 10 SPPs this will mean at least one report per day from each region and three to four reports per day at the Block PHC. In addition, if there is any untoward case or a sudden increase noted, additional reports may be sent. Emergency telephone numbers will be made available to contact MO PHC / Health worker. Flexibility will be provided in the method of reporting by the SPPs. Each PHC may choose an optimal method that is suitable in the situation. Any of the following methods may be used: a. b. c. d. Telephone followed by mailing of IDSP format by hard copy Fax Electronic mailing Courier i. Office of the DSO / CHC ii. Direct contact with Health Worker if necessary iii. Private Courier can be contracted Telephonic reports will be encouraged during epidemic situations so as to avoid delay. MO Block PHC / computer entry person / District Surveillance Officer will be able to receive information from the periphery. Routine reporting will be facilitated by the health worker visiting the SPPs in the rural areas on specific days assigned for reporting. In urban areas, telephones can be used or the health workers can collect reports from SPPs as done in the polio program. 41 16 MEDICAL COLLEGES Medical colleges are currently not contributing effectively to surveillance activities in the country. Diseases presented at medical colleges are not being reported to surveillance officers due to poor motivation and other commitments. In IDSP, a defined role for all the medical colleges of the country is being proposed. The following departments in the colleges will be the sites for reporting the diseases under surveillance. In this way it would become part of urban surveillance activity, because most of these colleges are situated in urban areas. It is proposed that one faculty member from each of the following departments will constitute an institutional IDSP sub-committee. The chairperson of the sub-committee can be the nodal person who will report to the district surveillance officer and ensure that relevant information is sent in on time. Principal / Medical superintendent (Chair) Community Medicine Medicine Pediatrics Chest and Tuberculosis Microbiology Cardiology The participants of the IDSP sub-committee are selected on the basis of diseases currently under surveillance in the program. Medicine and Cardiology are also responsible for NCD components of the IDSP. The sub-committee is chaired by a senior administrative staff member of the medical college so that participation in the program will be effective. In addition to data collection Medical colleges can contribute to the IDSP as Reference laboratories Quality Assurance / Evaluation Training Epidemic Investigation / response in collaboration with DSO or SSO (State Surveillance Officer) NCD Surveillance Reference Laboratory: Many state medical colleges are functioning as reference laboratories for specific microorganisms. They will continue to do the same under the IDSP. Members of the IDSP sub-committee can serve as members of the rapid response team at the district and state level if required. The evaluation and quality assurance team can include members of the medical college staff. Since, the staff in medical colleges in the state is often not administratively under Director of Public Health this allows for independent evaluation. IDSP plans to integrate the surveillance of communicable and non-communicable diseases in one program. The NCD risk factor surveillances are planned as regular surveys once in three to five years in different parts of the state in a cyclical manner. The members of the medical college sub-committee, particularly 42 cardiology and medicine will assist the director of Public Health in planning and executing the NCD risk factor surveillance. The participation of medical colleges will not only help IDSP activities as outlined above but, also help the institutions in the teaching and training of undergraduates and postgraduate students and in operational research in surveillance related issues. This would give students an opportunity to have hands on experience in surveillance while under training for the first time in the country, as they are the future health care providers and managers of the various programs. This would mean sustainability on a long-term basis for the IDSP. Medical college faculty members are particularly good at training issues since they are primarily teachers. IDSP plans to incorporate these faculty members in improving the training of IDSP personnel. Each Medical College will be encouraged to adopt an administrative block from the field practice area used for the training of medical undergraduate and postgraduate students. The surveillance data collected from this block will be provided to the district surveillance unit. Since most of the medical colleges are situated in the urban and semi-urban regions where surveillance is weak, this will provide additional inputs from the urban regions of India. 16.1 Responsibility of Integrating Medical Colleges: The state surveillance unit will take responsibility of training and facilitating the integration of medical colleges into the system. The director of Medical Education in the state will select one of the medical college team members as the overall coordinator for all the medical colleges’ activities in the state. The health secretary will facilitate the activity of developing the state IDSP unit in each medical college in the state. Medical colleges willing to take on the surveillance function as urban district surveillance unit (urban - DSU) will be provided data entry and other resources allocated to the district surveillance unit to facilitate this activity. The State Surveillance Unit will enter into a written memorandum of understanding with the medical college administration regarding performance of IDSP functions. At the central level interaction with the IMC by the MOHFW will emphasize the need for this integration. 17 DEVELOPMENT OF OPERATIONS MANUALS An operations manual has been developed for the IDSP. This is intended as a handbook for the people who are going to implement the program, especially at the district level. In addition parts of this manual with data entry, and reporting along with formats for reporting will be assembled as a simple field manual at the periphery. Thus it is envisaged that there will be two manuals, one for the District Surveillance Officer, which will contain all aspects of the IDSP including technical details, and another for the field level, which will lay more emphasis on data collection and transmission. The district operational manual will be disease specific and will deal with the core diseases identified by the IDSP and in each state disease specific conditions will be attached. This will be modular in structure and changes can be easily incorporated in this module 43 as disease conditions and surveillance techniques change with time. The Technical Operations manual will inform the managers of: The detailed role of the staff in IDSP - who will do what. The details of what has to be done. An overview of how things have to be done. Additional Reference manuals will be made providing details about various surveillance activities including 1). Reporting units, 2). Reporting, 3). Analysis, 4). Surveillance Action, 5). Feed back, 6). Monitoring and Evaluation These reference manuals will be available at the district surveillance office (DSO). This manual is intended for all those involved in the IDSP, especially for those at the District level. The contents of the Operation manual are: Introduction Case Definitions Role of the Functionaries - highlighting the roles of each of the staff / stakeholder involved in the IDSP. Recording and Reporting – deals with the details of how data has to be recorded in prescribed formats and reported to the other levels. Analysis - informs those involved in analysis on how to do it. Investigation and Response - gives generic details of how to respond in the event of an outbreak. Specimen collection and transportation – helps the MO to decide how best to confirm the clinical / epidemiological diagnosis. Feed back. The entire operations manual will be in modular fashion, so that later developments and state specific data can be incorporated into it. It will also need to inter - phase with the laboratory manuals and the IT manuals. The following Reference manuals will be prepared and made available to enhance the skills required at different levels. i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. Manual of case definitions Manual for data collection Manual of data entry and compilation Manual for report generation, analysis and interpretation Manual for containment measures Manual of outbreak investigations Manual of guidelines for epidemic preparedness and response Manual of standard treatment guidelines Manual for lab technicians Manual of computers and software Administrative manual 44 xii. 18 Relevant excerpts of public health act on surveillance ANALYSIS Analysis is necessary at all levels for the optimum utilization of information. However, at the periphery only frequency tables are necessary and this will be automated by the use of computers. More detailed analysis is necessary at the district, state and central levels so that summary feed back reports and interpretations of results of surveillance data is possible without delay. The analyzed reports need to be sent to the district / state administration and other stake holders and will guide the surveillance actions. Initiate response at appropriate level Monitor disease control programs Identify emerging epidemics Assist in allocation of resources Mobilization of public support for health programs 18.1 Types of analysis Data analysis has to be made on the basis of: Time Place Person These reports need to be tabulated and percentages need to be calculated by age groups affected and gender. If mortality is an issue, these need to be calculated from available data. Modelling can be done based on information on both sentinel and regular data collection to calculate disease burden in the community. Analysis will also look into 1) Timeliness of reporting units 2) Completeness of reporting 3) Trend changes between reporting units (between private and public reporting units located in rural and urban areas respectively). Most of the primary analysis will be automatic background activity of the computer program at the district and state levels. The program will produce results on trends of disease, of time and space, and produce reports regularly, and on detecting deviations from the normal. Specific additional analysis required for each disease will be performed by the district and state surveillance officer. The details of the type of analysis for individual diseases will be dealt under the IDSP manual in greater detail. 18.2 GIS Software Geographical Information System software (eg: Health Mapper) will be utilized to generate spot maps and understand disease frequency and the relationship with geographic variables and other 45 variables relating to environment and population. The tool will also help to disseminate information more optimally as a social mobilization tool and to obtain political support for the program. Use of GIS facilitates faster and valid interpretations of changing trends of disease in time and space. The GIS system will function only if valid data is collected and analyzed at the district level. The program will incorporate GIS into the system after the basic levels in performance in surveillance activity have been established in the participating states. It is expected to be part of the program in at least some states with advanced health delivery status, by the second year of the program. 19 SURVEILLANCE ACTIONS 19.1 Feedback and sharing information Sharing of information with all stake holders for effective public health action is the primary purpose of the IDSP. Regular reports generated by the district surveillance unit will be shared with all the stakeholders of the program at the district level and all reports generated by the state surveillance unit will be shared by the stakeholders at the state level. The reports will be available through internet / intranet services which can be obtained by dial up services to the district surveillance unit and through the IDSP network at the district level. The stakeholders include: 19.1.1 Periphery Medical officer of PHCs Sentinel Private Practitioners participating in IDSP Participating laboratories 19.1.2 District All members of the district surveillance unit State Surveillance unit District Public Health Laboratory Sentinel Private Hospitals participating in IDSP Program officers of disease control programs Medical Colleges Other members as decided by the district surveillance unit officer 19.1.3 State All members of the state surveillance unit National IDSP Officer at Delhi 46 State level Disease control program offices State laboratories Medical Colleges in the state Others as decided by the state surveillance unit In addition a monthly surveillance bulletin will be published by the state officer and dispatched to other stakeholders in the state similar to CD Alert by NICD. The state surveillance unit may contract private agencies to do this work. 19.1.4 Center Dte.GHS; Ministry of Health and Family Welfare ICMR, NICD, NIB, CBHI Other partner agencies as identified by MOHFW In addition a monthly summary bulletin will be issued to all other stake holders of the program. 19.2 Response to the Surveillance Information By establishing surveillance units at the district, state and national levels the project provides, for the first time, resources and a structure with in which a more adequate response to the surveillance information collected can take place. The IDSP manuals set out case definitions and trigger levels (e.g. number of suspected cases in a specified time and location) for each of the diseases/health conditions under surveillance. The responses to be made when each of these trigger levels is crossed for one of the communicable diseases under surveillance are also specified in the manuals together with the reporting and follow-up actions to be taken - a general summary of these actions is shown in the table below. Details for each of the diseases are given in the District Operations Manuals for the project. The software to be developed in this project will alert district level staff when the triggers have been crossed and will also send information to the state if appropriate action by the districts is not notified within a specific time. For non-communicable diseases the situation is different - the frequency of collecting information is lower, the response time is longer and the interventions of a different nature. The surveillance information is collected through periodic surveys, on a three-year cycle and the information will then be used to plan interventions to be carried out by the state and districts. 47 Level Routine Activities Trigger for Action Action 1. Local Health Worker • monitoring of illnesses (continuous) • syndromic reporting to CHC (weekly) • refer patients to PHC / CHC • suspected case count above disease specific action threshold specified for the condition • unusual syndrome causing death or hospitalization • inform MO PHC/CHC • active search for similar cases • collection and transport of biological samples to lab • IEC for public • integration with non health personnel in the community 2. CHCMO/ PHCMO • verification of local health worker case reports (weekly) • verification of laboratory reports (weekly) • feedback to local health workers (weekly) • suspected / confirmed case count above diseasespecific action threshold • notification from DSU of apparent outbreak 3. District Surveillance Unit/Committees • data entry of sentinel • confirmed case count data from institutions not indicating local outbreak linked directly (weekly) • analysis including calculation of case counts and descriptive epidemiology (weekly) • monitoring and evaluation including assess accuracy and completeness of submitted reports (weekly) • collection and trend • verification of reports of outbreaks from health worker (within 24 hours). • verification of reports of outbreaks in the rumor registry (within 48 hours) • disease-specific control activities (immediately) • collection and transport of biological samples to lab • reporting of suspected and confirmed cases to DSU (within 24 hours) • IEC and integration with village health committee • outbreak investigation under DSU direction • initiate outbreak investigation through Rapid Response Teams (RRT) • provide coordination to outbreak response activities involving CHCs • initiate disease control measures and treatment • notify SSU • facilitate private /public partnership in outbreak response 48 analysis of water quality, air quality, and road accident data • reporting to SSU (weekly) • integration and facilitation information flow to district program managers. • feedback to reporting units (weekly) • outreach to community organizations 4. State Surveillance • compilation of DSU • confirmed case count Unit/Committees reports (monthly) indicating multifocal • assess reporting outbreak or pandemic performance of DSUs (monthly) • reporting to CSU (monthly) • feedback to DSUs (monthly) • implementation of risk factor surveys (every 3 years) • plan and implement risk factor control campaigns based on survey information • coordination of training activities • implementation of external quality assurance program for labs • coordinate activities with other relevant state agencies • advise DSUs on disease control measures • monitor situation and response (continuously) • notify CSU • deployment of state rapid response team if necessary 49 5. Central Surveillance Unit/Committees • development of national guidelines for case definitions and disease control • oversight and direction ofIDSP • compilation and analysis of SSU reports (quarterly) • coordination of regional and central labs reporting to international public health agencies (for selected conditions) • feedback to SSUs (quarterly) • reporting to World Bank • coordinate external quality assurance activities • uncontrolled multifocal outbreak or pandemic • international health threat potentially affecting India • advise SSUs on disease control measures • monitor situation and response (continuously) • notify international public health agencies • seek and coordinate international assistance if necessary Annual Surveillance Reports Publication of annual surveillance reports by district, State and Centre Surveillance Units would be disseminated to all Stakeholders including leading private providers. Besides specific information on occurrence of core and state specific diseases, these reports would also include physical progress, case studies and other relevant information. These reports would also provide feedback to various participating units. This activity would be one of the key project deliverables and will be closely monitored. Integration of Surveillance under various disease control programme One of the important objectives of IDSP is to integrate surveillance activities carried out under various vertical disease control programmes. To facilitate integration, the project envisages various activities like data generation using uniform and common reporting formats, integrated training of health workers, common mode of transmission, collection compilation and analysis of data and using common IT network for transmission to State and Centre levels. Surveillance under National Disease Control Programmes relating to Malaria, Tuberculosis, HIV/AIDS, Diseases under RCH (Measles, Polio, Acute Diarrhoeal Diseases) and state specific diseases would be integrated. 19.3 Levels of response The program will specify response levels for each of the target diseases under surveillance. Different trigger levels will be described for the surveillance conditions, so that specific surveillance related action can be predetermined based on the levels set for the condition. The 50 trigger levels will be modified, based on incidence of the disease in the region, by the local health authority according to the needs of the program. Trigger –1 Trigger –2 Trigger –3 Trigger - 4 Trigger - 5 Local response by health worker and MO. District level response by DSO & RRT. State Level Response to an established outbreak State Level Response to established epidemic Disaster response. Details of the response in relation to specific diseases will be described in the IDSP manual. 19.4 Response to surveillance challenges Trigger-1 Response (HWs) Trigger-2 Outbreak investigation and response (CHC MO/ PHC MO) Trigger-3 Outbreak investigations and response (District Surveillance Unit) Trigger-4 Epidemic investigation and epidemic response (State Surveillance Unit) Trigger-5 Disaster response (Center, State, District, Local) Trigger levels will depend on the type of disease, number of evolving cases. These will be region specific depending on incidence of disease and previous reporting trends. E.g.: Single case of Flacid paralysis or plague - Initiate response at state / national level. For diarrhoeal disease the number of cases will trigger a variable response. 19.5 Response at local level The disease pattern may follow an expected time and seasonal pattern. The HW will be trained to take local action to control predicted outbreaks under the direction of local PHC MO. 19.6 Outbreak investigations and response Currently many states have formed epidemic investigation and response teams to tackle disease outbreaks in the country under the pilot project of NSPCD at the state and district level. These teams are currently not effective because there is delay in information processing and absence of real time analysis of data. Most of the times the information comes from lay persons and the health authorities require verification of this information causing additional delays and hence timely and effective interventions are difficult to initiate in the current system. Timely response therefore needs local appraisal of the developing outbreak and intervention to be initiated without delay. In IDSP a regular analysis and trends report will be generated and specified trigger levels for specific conditions will be identified as per the operational manual. It will be the responsibility of the district surveillance unit under the leadership of the district surveillance officer, to initiate the first action and to notify the state surveillance officer. 51 19.6.1 Definition of outbreak An outbreak or epidemic is defined as the occurrence in a community of cases of an illness clearly in excess of expected numbers. While an outbreak is usually limited to a small focal area, an epidemic covers large geographic areas and has more than one focal point. 19.6.2 Threshold levels The first step in investigating an outbreak is to detect it. One of the common ways of early detection is to review the data from routine surveillance and check if it crosses threshold levels. Details of this are provided in Section 2. The second technique is more generic, it is the detection of unusual events. The number of cases, needed to be termed an outbreak varies according to several factors. It depends on past trends of the disease, case fatality rates (CFR) and potential to spread to other places. For some diseases a single case is an epidemic e.g. Polio. States and districts should establish criteria based on their local situations. For example, five cases of similar illness of acute onset within an incubation period of that disease or death in a village could be considered as an outbreak. These threshold levels will be based on previous experiences with that disease confirmed by data of the previous years. This data maybe available as monthly reports of cases and would need to be modified to a weekly frequency. 19.6.3 Sources of information The nodal person for surveillance will scrutinize all the data received in the health facility from: Routine Surveillance: Peruse the reports, laboratory results and see if the incidence of disease has crossed the threshold levels. Rumor register: All health facilities should maintain a rumor register and enter information in the register whenever a suspected outbreak is reported by a layperson. Media: Daily scanning of newspapers and other media reports of suspected outbreaks must be carried out. Every report must be verified. The nodal person will take immediate action if the threshold level has been crossed and report the outbreak to the next level after verification of the outbreak. If the number of cases are very high (exact figures could be fixed for each disease by the states), he will immediately inform the district and state headquarters depending on the extent of the outbreak. For example, in Maharashtra, if there are more than 25 cholera cases, then the PHC MO will inform the district, similarly if there are more than 100 cases, then the MO will inform the state. 19.6.4 Verification of the outbreak The preliminary step of the outbreak investigation will be to confirm the outbreak. Much time may be wasted due to a false alarm. Even if the outbreak is suspected from the routine 52 surveillance data, it must be verified (lest it be a data entry error). The reported cases should initially be verified by the PHC MO. If there is evidence of an outbreak, then necessary action needs to be taken. 19.6.5 Investigating an outbreak Efforts will be made to investigate each and every outbreak. Investigations would reveal why the outbreak occurred, identify high-risk groups and areas, and evaluate control measures. Such investigations, other than controlling the outbreaks, help in identifying system failures and by taking necessary corrective action, further strengthen the health services. 19.6.6 The District Outbreak Investigation Team (DO IT) The DEIT is a multifaceted team that looks into the various aspects of an outbreak. There will be a DEIT team at each district. A similar team may be available at the regional and state level to support the DEIT if and when and if necessary. Composition of this team is: i. Nodal officer (*) in charge of disease control in the district (Epidemiologist) – the team leader, usually with public health training and experience. ii. The Clinician – either a physician or a pediatrician who is able to make a clinical diagnosis from the cases. (Member of nearest medical college surveillance team) iii. The Microbiologist – (From District PH Laboratory) to collect the specimens and to transport them appropriately. Many districts may not have a microbiologist so a laboratory technician may be substituted. Where necessary, the state team should also include an entomologist in the team. iv. District administrative nominee (not below the rank of Tahsildar). v. Any other person in the list of surveillance consultants with DSO. vi. The Health Assistant – his role is to assist the team in the community, do surveys, make community contacts and mobilize the community when necessary. He would also be responsible for organizing the logistics. *The nodal officer will be selected from the program officers of disease control programs other than the district surveillance officer. The DSO should not be the investigating officer to avoid conflict of interest. The nodal officer will coordinate the selection of team leader for the DEIT based on the type of disease outbreaks. For suspected Polio and Malaria, the disease control officers for the program will head the DEIT. For unknown epidemics and for other diseases DEIT will be selected from the available program officers. All program officers at the district level should obtain training on a rapid response team and epidemic preparedness. The DEIT will be allotted resources specifically for response related activities so as to be effective. They will need: A dedicated and functioning vehicle so that they are able to visit the site at short notice. (This will be made available from existing vehicles at the district level by the DSO authorized by the District Collector) 53 Drugs so that they can start the preliminary treatment. Diagnostic reagents and kits for doing preliminary diagnosis. Facilities to transport the samples. As required, state and national level teams can be brought into action as per predefined levels of the spread of the outbreak in the region and the type of disease. 19.6.7 Outbreak Response Even as the outbreak is detected, and is being investigated, control measures need to be instituted. These may be general measures, till the specific source and route of transmission is identified. For example, if one is suspecting water borne disease, then one should start a campaign requesting people to use safe drinking water. Containment measures may be divided into general measures and specific measures. The basic principle in control and containment is given in the following figure. FIG. PRINCIPLES IN CONTROL AND CONTAINMENT Non-infected person Infectious person / agent Immunization Chemoprophylaxis Infected person Early detection and Good case management Diseased person Early detection and Good case management Death 54 Depending on the disease, the most effective specific measures are instituted as specified in the manual of IDSP. At the time of initiation of investigations into an outbreak, the district surveillance office notifies the state surveillance officer. Based on the results of the outbreak investigation and preliminary assessment of the team, a decision to call for state level response to control the outbreak or its spread to other districts will be made. The levels of occurrence of diseases for each region will be predetermined in the program manual based on changing incidence of the disease in the region. IEC activities will be initiated through village health committee meetings and other community leaders to control the disease in the region in all cases. 19.6.8 Daily situation updates During the period of the outbreak the nodal MO should continue to give daily situation updates to the next level. This should continue even when the DEIT has started its investigation and should include the list of new cases, laboratory results received, any new findings, any containment measures taken etc. This daily report should continue till the end of the outbreak (i.e. no suspect case during a period which is double the incubation period). However, it is important that these updates are kept as simple as possible – thereby sparing the MO unnecessary work. 19.6.9 Interim report of DEIT The DEIT will submit an interim report within one week of starting their investigation, response and control activities. The report should cover verification of the outbreak, total number of affected cases deaths, time, person, place analysis, management of the patients, likely suspected source, immediate control measures implemented, etc. The report will include reports by the physician and microbiologist, and entomologist (where applicable), the laboratory results received during that period, environmental factors, etc. It will also have a provisional hypothesis of the cause of the outbreak and comments / recommendations, if any, including whether any further outside help is necessary. 19.6.10 Final Report of DEIT One week after the outbreak has ceased, (double the incubation period of the diseased without a single case) a final outbreak investigation report must be submitted by the EIT. If the epidemic is prolonged, a summary of the action taken and results obtained will be documented and submitted to the District Collector within one month of the initiation of action through the district surveillance officer. This report must be comprehensive and give a complete picture of the multi-factorial causes of the outbreak, the precipitating factors, the evolution of the epidemic, description of the persons affected, time trends, areas affected and direction of spread of the epidemic. It should have 55 complete details of laboratory results including regional laboratory report (cross verification and strain identification), confirmation of the provisional diagnosis and other relevant information. Documentation of the epidemic is an important step in outbreak investigation. Useful lessons can be learnt if the documentation is complete and data properly analyzed. The information will be useful in drawing up long-term strategies for reducing the risk of outbreaks in the future and in more effective handling of an outbreak, should it occur. It is also important that feedback from the report is shared with the lower levels and also other districts. Publication in a journal will ensure wider circulation of the lessons learnt. 19.7 Epidemic investigation and response at state level If the outbreak investigations reveal the need for state level response or information received and processed at the state level indicates a potential or real epidemic, the state level investigation and response should be initiated by the state surveillance unit under guidance of the state surveillance officer. There will be up to three state level rapid response teams and each team will consist of the following: i. State Surveillance Officer / Nominee ii. Microbiologist from the State Public Health Laboratory iii. Nodal officer in charge of disease control program in the state iv. Consultant Epidemiologist v. Representative of IDSP sub-committee of medical college Actions: At the time of initiation of the epidemic response, the Director of Public Health, Secretary of Public Health would be kept informed of the progress of the epidemic and results of the investigations and interventions. The State Surveillance officer will notify the Central Surveillance office in MOHFW, so that if needed, a national level response could be initiated by ICMR and NICD without delay. Specific public health actions will be listed and defined in the operations manual for each level of operations for a specified disease. The summary of the action taken and results obtained will be documented and submitted to the Secretary Health within one month of the initiation of action. 19.8 Disaster management Disasters may be defined as events that are outside the control of local resources to cope with. Out break of diseases like plague in Surat or natural disasters like earthquakes and floods could initiate a disaster management plan in IDSP. Disasters could be epidemic induced or impact on disease control. The disaster management plan of IDSP would take into account these situations. Current Situation: Current disaster management plans at the nation level have the following structure. At the national level the Prime Minister presides over the cabinet committee and the 56 policies of this committee are carried out by the Crisis Management Committee chaired by the Central Relief Commissioner and Additional Secretary - Ministry of Agriculture. They provide financial, technical and material assistance to the state governments who are primarily responsible for managing the disaster. At the state level, the crisis management group works under the chairmanship of the Chief Secretary with senior level functionaries of various departments as members. The action plan for disaster management is district based and formed by the district administration in consultation with the crisis management group. As part of integrated disease surveillance, the epidemic response teams at district and state levels will coordinate in the event of disaster: i. ii. iii. iv. v. Improving preparedness for Response - computer networking, information sharing, GIS. Allocation of emergency stocks of medicines and equipments. Disaster prediction and warning – Early warning of epidemics. Improving hygiene and sanitation. Social mobilization and public awareness of potential disasters in the country. The operations manual for IDSP will deal with specifics in disaster management and how IDSP will inter-phase with the crisis management group at the state and central levels. TABLE GENERAL GUIDELINES ON TRIGGER LEVELS Health Condition Acute Diarrhoeal Diseases Cholera Typhoid Trigger Event Rising Trends Higher as compared to previous years. Clustering of cases in time and space. In endemic area, rising trends or higher as compared to previous years. In non endemic areas, even a single case. Malaria Rising trends. Higher as compared to previous years. Clustering of cases in time and space. Rising Trends. Higher as compared to previous years. Clustering of cases in time Response Investigate and contain if small and focal. If widespread or of higher magnitude, then involve the district surveillance unit. In endemic areas investigate and contain. In non-endemic areas, investigate and contain. Involve district/ state authorities. Investigate and contain if small and focal. If wide spread or of higher magnitude, then involve district and state surveillance teams. Involve the district and state authorities depending on the magnitude of the problem. 57 Polio and space. In tribal or remote areas, even a single case. In other areas clustering of cases. One confirmed case Water Quality Fecal contamination. Above permissible levels Air Quality If parameters above permitted levels Tuberculosis HIV Changing Trends in Disease Changing Trends in Disease/Infection Measles State Specific Diseases Investigate and contain if small and focal. If widespread or of higher magnitude, then involve district authorities. Involve, District, State, National Surveillance Units. Inform local health authorities on changing trends and levels of chlorination. Develop feed back to community on changing trends in geographical area. Involve the local communities. Involve the local communities. Will be specified in the State PIPs. 20 ADMINISTRATIVE STRUCTURE OF IDSP There is increasing recognition of the fact that the surveillance activities involve actions at multisectoral levels, which need to be closely coordinated. In many states the activities of surveillance and their coordination have so far been restricted to mainly the health department, despite the fact that the control over the causes that give rise to epidemic prone diseases are in the hands of other departments of the Government. For example, quality of water and its supply and sanitation are under the departments of urban and rural development. In urban areas, issues related to water supply, water quality and sanitation are dealt with by the municipal corporations, which have no direct coordination with the health authorities in the state. Therefore, in the present project an effort has been made to evolve an administrative structure, taking into account the peculiar circumstances of each state, which further takes into account the multi-sectoral nature of the activity. It is proposed to set up Surveillance Committees at Central, State and District levels to perform coordination functions between various stakeholders, review the surveillance activities at regular intervals (monthly), identify trouble shooters and suggest mechanisms to rectify them, initiate internal and external evaluations of the IDSP activities at different levels. These committees will advise the Surveillance Officers (i. e. the nodal officer) at all the three levels to operationalize the suggestions of the steering committees and also manage the program on a day-to-day basis. 20.1 Administrative structure at the national level It is proposed to set up a central surveillance unit, which would be based at the Dte.GHS, Ministry of Health and Family Welfare. The unit would be headed by the Program Officer of the 58 rank of Deputy Director General and assisted by an Assistant Director General along with supporting staff such as technical officers and consultants as may be required for the program. The staff for the central surveillance unit would be engaged either on deputation from NICD, ICMR, as well as any other organizations under the Ministry of Health and Family Welfare or as contract basis. The unit would also set up a control room with facilities for communication in the nature of FAX machines and computers, as well as strong infrastructure for MIS. This would act as headquarters during epidemics and disasters as well as a center for trend analysis of data received from all over the country. The central surveillance unit would take up technical charge of implementation of the IDSP. Administratively, this unit would report to the Health Secretary and Secretary Family Welfare through the DGHS. For administrative matters, a Joint Secretary in the Department of Health Incharge would be assisted by DS / Director in the Public Health Division. [ Proposed Structure at Central Level National Disease Surveillance Committee National Executive Committee National Surveillance Unit Technical Division DDG (IDSP) ADG (IDSP) Consultant (Procurement) Consultant (IT) Consultant (HRD) Administrative Division JS (IDSP) Director/DS (IDSP) US (IDSP) Accounts Officer Consultant (Finance) Data Manager Data Processing Assistants Statistical Assistant Data Entry Operators Steno/Office Assistants Class IV 1 2 1 2 2 2 Proposed Structure at State Level State Disease Surveillance Committee State Executive Committee State Surveillance Unit Joint Director (SSO) Consultant- Technical & Training Consultant -Finance & Procurement Data Manager 1 Data Entry Operators 2 Office Assistant 1 Class IV 1 59 Proposed Structure at District Level District Disease Surveillance Committee District Executive Committee District Surveillance Unit Deputy Chief Medical Officer as DSO Data Entry Operator 2 Account 1 Administrative Assistant 1 ORGANOGRAM NATIONAL SURVEILLANCE COMMITTEE Director General ICMR Director General Health Services JS (Health) (Co. Chair) JS (Family Welfare) National Program Managers Polio, Malaria, TB, HIV - AIDS Chairperson* National Surveillance Committee IMA Representative JS (FA) NGO Director NICD Consultants (IndiaCLEN / WHO / Medical College / others) Representative Ministry of Environment Director NIB Representative Ministry of Home National Surveillance Officer (Member Secretary) * Secretary Health or Secretary Family Welfare (to alternate) 20.2 The functions of the central surveillance unit Acting as the nodal point or control room at the central level for coordinating responses to requests received from states during epidemics and disasters. Analysis of data received from the states and provide feedback on trends observed. Form and supervise the movement of the rapid response team at the central level to supplement the efforts of states during disasters or epidemics of very large magnitude. 60 These rapid response teams would be headed by an epidemiologist and would be staffed by one microbiologist, one clinician and one laboratory expert. Entomologist, anthropologist and related persons would also be kept in panel and called in when required. These experts would be drawn not only from central agencies like NICD and ICMR but also from other agencies like medical colleges and specialized institutes like NIV, NTI and MRC. There would be at least five such teams and this surveillance unit would form a panel of experts so that teams could be sent out to two or three places at the same time. Coordinate the activities of central agencies such as NICD, ICMR and referral laboratories under the program. Monitor the progress of implementation of all the different components under the program. Ensure implementation of quality guidelines and standard operating procedures evolved under the program. Obtain reports from states on the various activities under the programme including expenditure and send reports and reimbursement claims as required by the World Bank through the financial controller. Report regularly to the central surveillance committee set up under the chairmanship of the Health Secretary at the central level which is referred to later. At the central level, a committee overseeing all matters relating to surveillance in the country would be set up under the chairmanship of the Health Secretary, with the other members being DGHS, DG(ICMR), Dir(NICD), Dir(NIB), JS(PH), representatives from the Ministries of Agriculture and Rural and Urban Development and Department of drinking water, as well as representatives from NGOs like Voluntary Health Association of India as well as the Program Officer. The committee shall meet at least once a month to consider the monthly report on surveillance activities that would be prepared by the Program Officer and shall meet as and when required during disasters and epidemics. 20.3 Administrative structure at state level It is proposed to setup a state surveillance unit at the state headquarters, which would work under the chairmanship of State Health Secretary. Director of Public Health or her / his equivalent would be designated as the co-chair person. This unit would be responsible for: The collation and analysis of all data being received from the districts and transmitting the same to the central surveillance unit. Coordinating the activities of the rapid response teams and dispatching them to the field whenever the need arises. Monitoring and reviewing the activities of the district surveillance units including checks on validity of data, responsiveness of the system and functioning of the laboratories. Coordinating the activities of the state public health laboratories and the medical college laboratories. 61 Sending regular feedback to the district units on the trend analysis of data received from them. Coordinating all training activities under the project. Coordinating meetings of the state surveillance committee, which is referred to in later paragraphs. 20.3.1 State Surveillance Committee A state surveillance committee is to be set up in each state under the chairmanship of the Health Secretary to oversee all the surveillance activities in the state and will be administratively responsible for program activities in the state. States would be free to make any variations as long as the general structures and principles behind the structure are preserved. The chairmanship by the Health Secretary is vital considering that the coordinating role of this committee with other departments during large-scale epidemics is going to be very vital and it was felt that the Health Secretary would be in a better position to do so. A TYPICAL ORGANOGRAM AT THE STATE LEVEL Director Health Service Director Public Health (Co. Chair) Director Medical Education State Program Managers Polio, Malaria, TB, HIV - AIDS Representative Water Board State Data Manager IDSP Head, State Public Health Lab NGO Chairperson* State Surveillance Committee Medical Colleges State Coordinator State Training Officer Representative Department of Home Representative Department of Environment State Surveillance Officer IMA Representative (Member Secretary) * State Health Secretary 62 The members of the committee will include: 1. Health Secretary (Chair person) 2. Director of Public Health (Co-Chair) 3. Directors Health Services, Medical Educations (HODs) 4. Program managers of TB, Malaria, Polio, HIV 5. Representatives from Department of Environment and Home 6. Head of the State Public Health Laboratory 7. Representative of the state unit of the Indian Medical Association 8. Coordinating member from state Medical colleges surveillance team 9. One representative from the NGOs working for public health 10. State Surveillance Officer. (Member Secretary) The state surveillance committee would meet at least once a month when there is no epidemic situation and meet at more frequent intervals during times of epidemic or large outbreaks. 20.4 Administrative structure at district level 20.4.1 District Surveillance Committee The district surveillance committee will be responsible for the regular running of the program. The district surveillance unit will be chaired by the District collector / District -Magistrate. The members of the DSU will include: i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. District Collector (Chair person) Chief Medical Officer District (Co-Chair) Program officers of PH, TB, Malaria, HIV, Polio Representative of Medical College Representative of SSPs in the district Police Superintendent Representative from the Water Board NGO representative Chairman District Panchayat Board Head of the District Public Health Laboratory The District Surveillance Officer (DDPH) (Member Secretary) The Committee will meet once a month regularly and as often as needed during an epidemic. A routine report of this meeting should be forwarded to the State Surveillance office once a month to understand the progress and problems in various districts. Reports of these meeting will be forwarded to the National Surveillance cell once in three months. 63 District Program Manager Polio, Malaria, TB, HIV - AIDS CMO (Co. Chair) Representative Water Board Chief District PH Laboratory District Data Manager (IDSP) Representative Pollution Board Superintendent Of Police Chairperson* District Surveillance Committee IMA /PvtSector Representative NGO Representative District Training Officer (IDSP) District Panchayat Chairperson Medical College Representative if any District Surveillance Officer (Member Secretary) * District Collector or District Magistrate 20.5 Mechanisms for vertical coordination between various levels Vertical coordination will be as critical as the horizontal coordination mechanisms outlined above. While IDSP will be a decentralized district based program, the following issues necessitate vertical coordination as well Existing vertical disease control / elimination / eradication programs. Integration and coordination of regional and national reference laboratories. Management of national IDSP-IT network. Special training requirements by central, regional and state institutions and organizations. Response to surveillance data. External quality control. Monitoring and evaluation. International commitments on disease control. Planning and resource allocation. The CSU will hold discussions with the Program Management Units of the Major Disease Control Programs to work out modalities and time-frame for integrating Surveillance activities carried out in these programs with IDSP. GOI and the Bank will identify indicators to measure progress on this integration. Regular interaction between the functionaries from different levels must take place. It is proposed that at the state level, a meeting is convened by the State Surveillance Unit once every quarter for all district surveillance officers of IDSP to discuss the issues outlined above. 64 Similarly, the National Surveillance Unit will convene quarterly meetings of State Surveillance officers. During these meetings the problems faced in making progress by various states will be discussed based on quarterly meetings from State Surveillance cell and information generated from the IDSP database. Consultants and other stakeholders in the program will provide their feedback during these meetings. 20.5 List of partners and key stakeholders National Technical Institutions NICD,ICMR,NI,NABL,CBHI Other Agencies in the country Air/water Pollution Control Boards Police Administration Medical Colleges Indian Medical Association Other NGOs doing surveillance Multilaterla/Bilateral Agencies WHO USAID World Bank DFID Technical Agencies IndiaCLEN CDC 20.6 National Institute of Communicable Diseases (NICD) This institute is under the administrative control of the Director General of Health Services, Ministry of Health and Family Welfare, Government of India. It is involved in undertaking surveillance for major communicable diseases, and maintaining watch over newer health problems and recommending appropriate measures to the Government to tackle these problems. The institute has eight field stations. The NICD is expected to provide extensive support to the integrated disease surveillance program especially at the central level. Its functions are expected to include: Contribution of staff to the central surveillance unit and also providing technical backup on issues related to disease surveillance. Functioning as the premium referral laboratory, especially in investigations of unknown and newly emerging diseases. Providing guidelines and training of rapid response teams at central and state levels and equipping them to investigate outbreaks of newly emerging diseases. Participation in evaluation of the implementation of surveillance programs in various states. 65 Organization of training courses for various personnel as per the training needs. Preparations of protocols for investigation of various outbreaks and also manuals and guidelines for investigation of outbreaks and epidemics. The National Institute of Communicable Diseases (NICD) shall monitor the epidemic prone diseases and provide necessary technical support to the central, state and district authorities. On request NICD will also assist the states in investigation of outbreaks of unknown etiology, outbreaks with high case fatality rates, outbreaks with the potential of spread to other states and other such events for which assistance maybe requested by the state authorities. 20.7 Indian Council of Medical Research (ICMR) The Indian Council of Medical Research is an autonomous organization funded by the Union Ministry of Health and Family Welfare, administered through its head quarters in New Delhi. It has a network of 26 institutes located in various states in the country. The majority of them focus on a single disease of which six address regional health issues. The outreach is further strengthened by a large number of field stations in different geo-ecological sites in the country. ICMR is the premier agency for medical research in the country. The roles envisaged for ICMR are: Providing staff for the central surveillance unit as well as rapid response teams as per requirements. Integration of laboratories within the ICMR system with the IDSP, especially as referral laboratories for specific diseases. Undertaking research on newly emerging diseases and identifying new areas for surveillance. Providing any other research backup that may be required by the program. Providing training to the NIE for field epidemiologists. NCD Risk Factor Surveillance. Assist in monitoring and evaluation of IDSP. Quality control in the state laboratories for performing laboratory functions. Development and evaluation of new tools for surveillance. 20.8 Central Bureau of HeaIth Intelligence Central Bureau of Health Intelligence will maintain the National Data Base and assist in developing regular reports for the government. 20.9 National Institute of Biologicals National Institute of Biologicals will be responsible for accreditation of private laboratories in IDSP and in facilitating quality assurance of the participating laboratories, particularly in private and sentinel laboratories in the country. 66 20.10 Other agencies in the country doing surveillance 20.10.1 Pollution control boards The pollution control boards at different states and regional levels are responsible for monitoring outdoor air pollution in mega cities in the country. They already have data which is collected on a daily basis from the cities and published in a booklet. The IDSP will obtain this data on a weekly basis through the state surveillance unit and make it available to the health policy makers in the country. A memorandum of understanding will be made by the state pollution control boards and the state surveillance unit for this purpose. 20.10.2 Water boards The quality of water supplied in the urban regions of the country is controlled by the Water Board in the states. This information is very crucial, since water borne epidemics are included in the diseases under surveillance. A memorandum of understanding will be developed between the water board at the state level and the state surveillance unit to provide regular information on urban water quality at weekly intervals. This information will be collected at the district level by the district surveillance units. 20.10.3 Police administration at the states In many states Road Traffic Accidents (RTA) are being monitored by the police administration in each district. In Tamil Nadu and Maharashtra RTC information is available from police computers. Presently this is under surveillance in the North Arcot District Information system (NADI). A memorandum of understanding will be made between the police administration and state surveillance unit so that this information is collected at the district level each month and entered into the district computers. An efficient link up will be established so that information flow will be easy, and come directly from the police computers. 20.10.4Medical colleges This has been already dealt with under Medical college Integration and Urban surveillance in chapter 16 and 17. To facilitate this integration the state surveillance units will enter into a Memorandum of Understanding with the participating medical colleges. At the center interactions with the Indian Medical Council will be developed so that the importance of students and their awareness of disease surveillance is increased in the country. Please refer to sections on Epidemic Investigation, NCD surveillance, Training, Monitoring and evaluation, Laboratory for further information on the role of Medical colleges. 20.10.5 Private practitioners The informal health services provided by private practitioners both qualified and unqualified, contribute to total health care of the country. In many states, the unqualified health practitioners provide the bulk of the health services. The Sentinel private practitioners will include members from both the qualified and unqualified. The method of selection and phased induction of SPPs has been dealt with in another section. Support of Indian Medical Association and other professional bodies will be obtained to facilitate this integration. 67 20.10.6 Other NGOs doing surveillance Currently there are a number of NGOs who are doing community disease surveillance in the country. NADI in Tamil Nadu, UNICEF in Rajasthan and BAIF in Maharashtra are examples of this activity. These NGOs will be integrated in the activities of the IDSP. Memorandum of understanding will be made by the State Surveillance Unit with the NGOs involved with disease surveillance in the country. 20.11 International partners IDSP program has been strengthened through the efforts of the bilateral agencies like WB, USAID, DIFID who participated in developing the conceptual framework and funded the different stages of the program and in writing the PIP. USAID has on-going agreements with a number of technical partners and resources have been allocated for surveillance related activities. USAID will continue to contribute to the GOI surveillance initiatives by facilitating technical support from WHO, CDC and IndiaCLEN. The bilateral agencies will support monitoring and evaluation of the program in the future and provide valuable inputs for improving the program further. WHO has vast experience in the field of surveillance. They have helped to establish surveillance activities in Africa, Latin America and other developing countries. They will share their expertise in the Integrated Disease Surveillance Program in India. Currently they are involved with training assessment and development of the field manual for the program. WHO will provide financing and technical support including consultants in various disciplines. WHO representative (WR) office will act as the focal point for all WHO inputs and will work with the GOI. The World Bank has been in the forefront in assisting the government in developing the Integrated Disease Surveillance Program in the country. The financial assistance from the International Development Assistance (IDA) will facilitate the establishment of this unique program in the country. 20.12 Technical partners In addition to Technical Partners from National Institutes like NICD, ICMR, NIB, NABL, it is envisaged that the following agencies / networks will have an important role to play in strengthening the IDSP. 20.12.1 Centers for Disease Control – USA (CDC) United States has one of most effective disease control programs in the world. This is coordinated by CDC in USA. The CDC team of consultants will share their expertise in the different aspects of the program, especially in laboratory standardization and establishment of laboratory protocols and quality control. CDC will particularly assist in laboratory development, 68 bio-safety issues and training. They are also expected to play a role in training of laboratory personnel and monitoring and evaluation of the program. 20.12.2 IndiaCLEN Network The Indian Clinical Epidemiology Network is of medical colleges in India who have been active in public health and disease surveillance. Initially the INDIACLEN started as a small group of six medical colleges in India, but through its research activities it has now enlarged its activities to include more than 40 medical colleges in the country. The members are trained in clinical epidemiology, biostatistics and research methodology. There are also trained people in health economics and social sciences in the network. USAID in India has supported establishment of a good infrastructure in some of the medical colleges where the Clinical Epidemiology units were established. The network has been involved with antimicrobial surveillance, program evaluation, study of violence against women and children in the Indian setting. The network helped MOHFW in developing the PIP for the IDSP. IndiaCLEN network will assist the IDSP in the following areas: Provide consultancy services to IDSP. Assist the GOI in finalizing the state and national PIP. Assist in Human Resource Development particularly in data management, analysis and laboratory diagnosis Participate in monitoring and evaluation of the program 69 PART – IV SPECIFIC INPUTS TO IMPROVE DISEASE SURVEILLANCE 70 21 LABORATORY NETWORK FOR IDSP Laboratory support is essential to proper functioning of disease surveillance and hence comprehensive support will be provided for surveillance related laboratory work. This includes Incremental Infrastructure support Equipments to perform the specific tasks where necessary Additional reagents as required Communication and networking Training and human resource development to carry out high quality work Communication and Training needs for the program are taken up in separate sections. This section will primarily deal with Infrastructure, Equipments and Reagents. Currently, the laboratory support in many areas appears weak and the available system is not integrated well with the district and state surveillance program. There is a need to define the specific roles of the various laboratories at PHCs, district and state levels and strengthen these systems. Areas that need special attention include technology and infrastructure for performing essential diagnostic tests at the district level, particularly microbiology cultures, bio-safety management and quality assurance. The laboratory network for IDS will be established at four levels of functions: Peripheral Laboratories and Microscopic centers (L1 Labs) District Public Health Laboratory (L2 Labs) Disease Based State Laboratories (L3 Labs) Regional Laboratories IDSP and Quality control Laboratories (L4) Disease based reference Laboratories (L5) 21.1 Peripheral laboratories (L1 Laboratories) Peripheral laboratories will function so as to assist the laboratory diagnosis of: i. Malaria ii. Tuberculosis iii. Typhoid iv. Chlorination level of the drinking water source in the periphery v. Fecal contamination of water Existing peripheral laboratories at the PHC level are capable of handling microscopic examination of sputum and blood smears and are currently undertaking this activity under TB and Malaria Control Programs. Typhoid can be diagnosed at the periphery using ‘Typhi Dot’ test which can be performed easily and has established validity and reliability. Kits are available for detecting fecal contamination of water, which can be used at the periphery and these will be made available. 71 In the urban regions the microscopic centers for TB and Malaria Program can continue to provide inputs on these diseases, but additional selected private laboratories and established and accredited laboratories will be brought into the network as sentinel institutions in the periphery. Table: Peripheral laboratories can be classified as follows: PHC Laboratory Tuberculosis Sputum AFB smear Confirm 0.5% Malaria Blood smear for Malaria Confirm 0.5% Typhoid Rapid Diagnostic test (Typhi Confirm 0.5% Dot) Water Quality Kit for chlorination test Confirm 0.5% Water Quality Rapid test Kit for fecal Confirm 0.1% contamination Urban Peripheral labs Microscopy center TB Tuberculosis Sputum AFB smear Confirm 0.5% Microscopy center Malaria Blood smear Confirm 0.5% Malaria Accredited Private Labs Tuberculosis Sputum AFB smear Confirm 1% Malaria Blood smear for Malaria Confirm .5% Typhoid Typhi Dot Test Confirm .5% Water Board Water Quality Kit for Chlorination test Confirm .5% Rapid test for fecal Confirm 0.1% contamination 21.2 Private laboratories Private laboratories will be brought under a licensing and accreditation system. Mandatory reporting for IDSP notifiable diseases will be enforced. They will report to the District Public Health laboratory at weekly intervals. Till accreditation is established, the private laboratories will be included as one of the sentinel reporting units as described in section dealing with private practitioners 21.3 Additional needs for peripheral laboratories Peripheral laboratories need minimal structural modification of the laboratory areas in the CHC to perform these functions well. Most of them are currently equipped with microscopes for performing microscopy for TB and Malaria. They will also be provided rapid diagnostic tools for diagnosing Typhoid in those presenting symptoms of prolonged fever and a rapid test kit for fecal contamination of water. A more detailed list of needs is given in the table below. 72 1 2. 3. 4 5. 6. 7. 8. 9. 10. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. INCREMENTAL NEEDS FOR PERIPHERAL LABORATORIES Equipments Estimated Units Incremental Needs Binocular Microscope with oil Available Nil immersion Lancet Available Nil Ice box Available Nil Stool transport carrier Not Available Needed Test tube rack Available Nil Table top centrifuge Available Nil Refrigerator Available Nil Spirit lamp Available Nil Smear transporting box Not Available Needed Sterile leak proof containers Not Available Needed INCREMENTAL NEEDS FOR PERIPHERAL LABORATORIES Supplies Estimated Units Incremental Needs Clean slides Available Nil Slide markers Available Nil Gloves Available Nil GBS Stain Available Nil Staining rack Available Nil Transport medium (Cary Blair) Not Available Needed Sterile test tubes Available Nil Plastic vials Not Available Needed Sterile cotton wool swabs Available Nil Rapid Diagnostic Kit Typhoid Not Available Needed Rapid test kit for faecal Not Available Needed contamination Blood culture bottles with broth Not Available Nil Zeil Neelsen Acid fast stain Available Nil Aluminium Foil Not Available Needed Cotton Available Nil Sealing material Not Available Needed Extra plastic vials for transportation Not Available Needed of serum 21.4 District public health laboratory (L2 Laboratories) The District Public Health Laboratory will be the backbone of the laboratory network under IDSP. Currently, the district level laboratories are the weakest link in the program. The district laboratories are expected to have a major role in the surveillance program and the existing infrastructure and administrative structure will be improved to undertake the following tasks. 73 EXPECTED ROLES OF THE DISTRICT PUBLIC HEALTH LABORATORIES Conditions Test Confirmation Additional Tests 1 Tuberculosis Sputum AFB smear Confirm 1% (both +ves and -ves)from Peripheral Labs 2 Malaria Blood smear Confirm 1% from Periphery 3 Typhoid Rapid Diagnostic Confirm 1% Typhi Blood culture on test and Blood Dot tests Positive 1% of suspected culture samples typhoid 4 Cholera Stool Culture ADD Stool culture Cholera Toxin Test confirmation in 0.1% of suspected cholera 5 Water Quality Chlorination tests 1% of samples Colony count and Colony count from periphery tested in 5% of Rapid test for fecal samples contamination Note: Facilities for Drug resistance tests for malaria & TB may be required at this level. 21.4.1 Administrative structure and personnel in District PH Lab Most of the district laboratories are now situated attached to District Hospitals and primarily perform the functions of a curative laboratory. These district laboratories will be brought under the control of the district Public Health officer at the level of Joint Director. These laboratories will be staffed by a qualified person who can undertake microbiological cultures. A person with microbiology training (Diploma in Clinical Pathology -DCP) will need to be posted at this level. Since it is unlikely that a sufficient number of MSc. microbiology level trained personnel will be available, DCP level training is considered sufficient, since in many universities DCP curriculum have six months of microbiology and can be provided on job training to undertake culture activities for IDSP. This is specified in the training section. Public Health departments will need to reallocate staff with microbiology training to district laboratories. If adequate numbers are not available, the state surveillance unit should contract qualified people temporarily for the job. At the district level integration of equipment and trained staff will be improved by bringing the DTC laboratory staff and Malaria laboratory staff within the district public health laboratory. Integration of DTC and Malaria program at the district level is crucial for effective functioning of the district level laboratory, since trained laboratory technicians are already available with these programs. 74 21.4.2 Needs at district laboratories The district public health laboratory will be included in the IDSP computer network, so that transfer of information on identified diseases can be promptly transferred to the district surveillance unit and to the peripheral reporting units, as soon as data becomes available. Details are given in the IT manual Equipment and Reagents: These laboratories need to be upgraded with equipment and infrastructure to provide this function. The following needs have been identified: EQUIPMENTS NEEDED AT DISTRICT LABORATORIES 1 2 3 4 Equipments What is needed Binocular Microscope with oil immersion Test tube rack Table top centrifuge Incubator 5 Water bath 6 Refrigerator 7 Autoclave 8 ELISA reader and Washer 9 Hot air oven 10 Bio-safety hood 11 Inoculating loops 12 Pasteur pipettes 13 Vortex mitxer 14 - 70 Deep freezer What is available and Where Incremental Needs Binocular microscopes supplied under To be supplied TB/Malaria program/NPSCD wherever required Available Nil Available in District PH lab Additional one needed Available at District PH lab Additional one needed Not Available 2 Available at District PH lab Small one available Not Available Available at District PH lab Not Available Not Available Not Available Not Available Not Available Needed Nil Needed Needed Nil Needed Needed Needed Needed Needed SUPPLIES REQUIRED AT DISTRICT LABORATORIES 1 2 3 4 Supplies What is needed Zeil Neelsen Acid fast stain Blood culture bottles with broth Rapid Diagnostic Test kit for Typhoid Dehydrated media What is available and Where Incremental Needs Available with District TB lab Not Available Nil Needed Not available Needed Not Available Needed 75 5 6 7 HIV diagnostic kit ELISA Diagnostic kit for water quality Screw capped bottles Available with NACO Not Available Nil Needed Not Available Needed 21.4.3 Other laboratories which may function as District PH Laboratories The laboratories of ESI HQ and Regional Railway Hospitals and Army Command Hospitals in some districts can take on the role of the district public health laboratory if memorandum of understanding can be arrived at with the state surveillance unit for that function. 21.5 State public health laboratories Most states have well developed state level laboratories capable of performing the roles of L3 laboratories. Labs in Medical colleges will be part of this level. The state level laboratories need not be in a single laboratory but can be a group of well-networked laboratories in the state, specific for diseases under consideration. The primary roles of the state level laboratories are to: Provide quality control of District laboratories Impart training of Laboratory Personnel at the district levels Participate in the epidemic investigation in response to surveillance challenges Link up with state and district surveillance units so that information transfer is optimized. Function as the Primary laboratory for NCD risk factor surveillance. 76 EXPECTED TESTS DONE AT STATE LABORATORIES 1 Conditions Tuberculosis 2 Malaria 3 Typhoid 4 Cholera 5 Water Quality 6. 7. 8. NCD surveillance Polio Measles 9. 10 11 Leptospirae Dengue Hepatitis 12 13 Anthrax Plague Test AFB Culture and Sensitivity Confirmation Perform in 1% of positive cultures from district level Confirm 1% from districts Sensitivity Testing in Confirm 1% of S.typhi isolates bacterial isolates at district level Cholera culture and Typing 1% of Cholera Cholera toxin test isolates from districts Colony count Confirm 0.5% from district levels Blood sugar, HDL, LDL Follow present procedures Kit for Measles IgM antibodies MAT Test for Leptospira IgM test for Dengue Serology for Hepatitis A, E, B, C Confirm 1% of samples from district Identification of Anthrax Identification of plague Objective Identify magnitude of MDR TB Pattern of AMR for S.typhi typing Identify pattern of bacterial infection Risk factor surveillance for NCD Confirm Polio Confirm Measles Confirm Leptospirae Confirm Dengue Quality control Hepatitis work Confirm Anthrax Confirm Plague State level laboratories will be identified by the State Health administration. In each state the State Surveillance Unit will select the laboratories to perform the above functions for IDSP. These laboratories will be chosen depending on the existing strength and willingness to perform the surveillance activity and can be from both the government and private sector. Most state level laboratories have the infrastructure and equipment which may need to be minimally supplemented to function effectively in the roles specified as state surveillance laboratories. Consumables may need to be provided for some diseases for which additional load is expected. State level laboratories are expected to do AMR testing on random samples of isolates from districts and this needs additional inputs. Most of the state level laboratories are already providing training for laboratory technicians at different levels. This may need to be tailored to suit the needs of the IDSP. Currently, the biggest 77 lacuna in state level laboratories is their connectivity. Some laboratories have got computers but there is not infrastructure for sharing the information. Development of a network is essential. Most laboratories will be provided additional dedicated computers, softwares, and telephone connectivity charges as part of this program. 21.6 Administrative Re-organization for Laboratory Work under IDSP The Department of Health at the State level will identify responsibility for administrative overseeing of the laboratory system. This individual will be designated as the state laboratory director. At the District Level, identify the individual who will be designated as the laboratory director and who will be responsible for management overseeing of the peripheral health centers. Selected Medical Colleges may be designated state laboratories and will provide services in their area of expertise. The state IDSP unit will enter into written memorandum of understanding (MOU) with department of medical education to assure recognition of roles and responsibilities. 21.7 Quality Assurance: One of the state laboratory will be designated as the organizational entity to provide training in quality assurance and to coordinate training activities. A calendar of training offered by various institutes and universities will be maintained and include training in laboratory methods / techniques, quality assurance, and management. Laboratory training will be provided to district laboratories in a central setting. In turn, district laboratories should provide appropriate training to PHC’s. The designated institution should be responsible for evaluation of training programs and should include pre-and post-test evaluations as well as on-site evaluations to determine changes in practice. Biological safety and hazardous waste – The laboratory director in each district can oversee and implement policy on waste management at district level. 21.8 Reference laboratories IDSP will have one central and four regional reference laboratories catering to routine work and outbreak investigations. The Central laboratory at NICD will function as the apex reference laboratory for IDSP. In addition, the following laboratories will be designated as IDSP regional reference centers in the four regions of India. 78 Along with the above designated reference laboratories, there are a number of laboratories of high standard in the country and they could be incorporated into the IDSP as reference laboratories for various specific disease conditions. 21.8.1 Strengthening National Institute of Communicable Diseases The epidemiological division and various laboratories of NICD will function as the apex laboratory for IDSP surveillance. Necessary inputs for improving the infrastructure of the central laboratory and facilities for training will be provided under the program. Currently NICD has a basic laboratory, this will be upgraded to a P3 laboratories. Additional funds will be provided for reagents and civil works. NICD will take on the following responsibilities: Participate in monitoring and evaluation of the laboratories Participate in epidemic investigations as required To prepare standard manuals of techniques for the constituent laboratories To serve as a training center for laboratory personnel and coordination of training programs for all laboratory technologists To serve as the central referral laboratory for all laboratories in the network of the National Surveillance program To provide technical supervision and guidance to the laboratories in the country To serve as a center for the preparation and distribution of certain reagents and biological reagents for the constituent laboratories. 21.8.2 National Institute of Cholera and Enteric Diseases, Calcutta as regional IDSP laboratory in the Eastern region Originally established as the Cholera Research Laboratory, its scope was enlarged in 1975 and renamed as NICED. The laboratory is primarily working on enteric bacteria but has enlarged its interest to HIV, Rotavirus and Hepatitis. It is a very well equipped and staffed laboratory (15 Microbiologists and 47 technologists) with advanced equipment for molecular studies available. The institute conducts courses in enteric diagnosis from time to time and is the only lab in the world carrying out Vibrio phage typing. 21.8.3 Microbiology PGI Chandigarh as the regional IDSP laboratory for the Northern region This laboratory is well equipped, well staffed and has vast experience in antimicrobial susceptibility testing. ICMR has designated laboratories as Reference centers for antimicrobial susceptibility testing for rapidly growing aerobic bacteria. They are taking part in WHO-NET programme for antibiotic resistance monitoring. 79 21.8.4 Microbiology Center at CMC Vellore regional Reference Center for the Southern Region This laboratory is well equipped, well staffed and has vast experience in antimicrobial susceptibility testing. CMC has been successfully coordinating the external quality control program for other laboratories in the country for many years. ICMR has designated this laboratory as a Reference center for antimicrobial susceptibility testing. 21.8.5 National institute of Virology, Pune regional IDSP reference laboratory for the Western Region It is the WHO collaborating Centre for Abroviruses and Myxoviruses. It was established in 1960 as a Arbovirus research laboratory. It has done yeoman’s service in epidemiology, lab diagnosis of virus diseases such as JE virus, dengue infection and other arbovirus diseases. It isolated and characterized Kyasanur Foreste Disease and played an important part in its control. It is now specifically working in the field of arboviruses, myxoviruses (surveillance of Influenza) Hepatitis viruses. It is well equipped and staffed. It has P3 and P4 facilities. A new building is ready for occupation. There are 15 scientists including virologists, epidemiologists and entomologists and 45 technologists. It conducts postgraduate courses in virology and also imparts individual training to scientists from India and abroad. It is a WHO collaborating center. A monoclonal based IgM ELISA for diagnosis of flavivirus infections i.e., JE, West Nile and dengue has been developed by NIV, Pune. The monocolonal antibody generated against JE virus has now replaced polyclonal flavivirus cross reactive human serum. TgG-HRP conjugate as well as biotinylated Mab are in use in IgM capture ELISA. Incorporating this reagent, NIV supplied the kits to various institutes in India and also to WHO for distribution to institutes in South-East Asia. Tests for diagnosis of Measles IgM and HAV IgM have also been developed here and are supplied to other laboratories. 21.9 Role of ICMR centers in coordinating Disease Specific Reference Laboratories in the country There are a number of ICMR laboratories in different parts of India which could function as reference laboratories for IDSP. The MOHFW and Central Surveillance unit will develop a memorandum of understanding with ICMR so that ICMR can closely collaborate with MOHFW in IDSP and the National reference laboratory network. Based on the present strength of the laboratories they could help in : Characterization of the strain e.g.; sero-typing, phage typing, molecular finger printing Repository of standard strains and reagents and their supply to constituent laboratories Production of diagnostic anti-sera and supply to laboratories in the network Production of reagents for antibody detection and their supply to laboratories in the network 80 Research in production of rapid diagnostic reagents To standardize methods, procedures and equipment and to supply these to constituent laboratories To serve as a provider of quality assurance for constituent laboratories To participate in International EQAS of laboratory disciplines The following conditions will have designated reference laboratories. These laboratories will be selected based on the expertise available and willingness to participate in IDSP. BACTERIAL Enteric bacteria: Cholera, Shigella, Salmonella Streptococcus pyogenes and pneumoniae C.diphtheriae Neisseria meningitides and gonorrhea Staphylococcus Tuberculosis Enteric viruses Arboviruses Myxoviruses Hepatitis viruses Neurotropic viruses HIV Malaria and filaria Parasitology Zoonoses Antimicrobial susceptibility of rapidly growing organisms VIRAL PARASITIC OTHERS RELATED REFERENCE CENTERS Vector control Statistics Vaccines production and quality control Epidemiology 81 21.10 Additional Reference Laboratories for quality control and accreditation 21.10.1 National Institute of Biologicals with AIIMS Delhi and CMC Vellore NIB will be requested to participate as EQA Provider for the IDSP laboratories at the state and central level. For Peripherals laboratories – Provider Medical College laboratories For District laboratories – Provider State / Medical College laboratories For States and Regional Laboratories – Central coordinator NIB and IEQAS For designated central, state and regional laboratories. Liaise with International QA laboratories coordinated by WHO Central coordinator – National Institute of Biologicals International collaboration with Quality Assurance Division, Central Public Health Laboratory, Colindale, London 21.10.2 National Accreditation Board for Testing and Calibration of Laboratories NABL will be requested to develop a compulsory accreditation process for all laboratories in the country to assure quality. Refer to chapter on quality assurance. 22 BIOSAFETY AND BIO-MEDICAL WASTE MANAGEMENT Currently, bio-safety issues and bio-medical management at all levels of health care delivery and laboratory services are not explicitly prescribed and practiced. The written guidelines when available are not implemented due to the health personnels poor knowledge, attitudes and lack of training. With the rising HIV epidemic in the community there is a gradual increase in the awareness of risk to the health personnel and of ‘Universal precautions’. There is concern that universal precautions are not feasible and are expensive and may not protect individuals. This has resulted in a reluctance, on the part of the health providers at various levels, to participate in programs requiring collection of possible infected material and taking care of affected individuals. Some institutions in the country are taking steps to safely dispose bio-hazardous waste and in the process are fulfilling their social obligations in this regard. For example, the Indian Air Force hospital in Bangalore has developed an improved waste disposal system with a multi-option approach, which is to be extended to all the major armed forces' hospitals in the country. Keeping in view the danger posed by the hospital waste, the command Hospital Air Force, Bangalore has developed a proper waste disposal system under a WHO project. The system adopts a multi-option approach under which an inventory of waste is made and hydroclave, microclave and autoclave incinerations are used to remove the toxicity. A similar system is planned in 28 major hospitals of the armed forces for a total outlay of Rs 103 crores. 82 22.1 Bio-safety issues in the proposed IDSP These are primarily related to transmission of infectious agents to individuals at risk. They are: Risk to health personnel during collection and handling of specimen. Risk to community on transportation of infected material. Disposal of hazardous waste in the program. These risks can be reduced by: Improving health practices by providers Developing training programmes on collection and transfer of specimens and cleaning and maintaining of laboratory Specific facilities and guidelines for disposal of bio-hazardous waste IDSP will address bio-safety issues related with health personnel and to the community by the following measures. 22.2 Improving health practices especially handling of sharps Developing a manual of Dos and Don’ts in mandatory day to day activities Training to prevent accidents Training in decontamination and sterilization Universal precautions during collection, transportation of biological specimens. 22.3 Improving infrastructure 24.4 Bio-safety cabinets Equipment for sterilization Systematic approach for collection and disposal of waste Management of bio-hazardous waste in IDSP Waste generated within hospital premises has three main components: Common wastes, for example, administrative office waste and kitchen waste; Pathogenic or infectious wastes (these also contain sharps); Hazardous wastes (mainly those originating in the laboratories containing toxic substances). The quantity of the first type of waste tends to be much larger than the second and third types. Ideally, these three types of waste should be separated. However, separation is possible only when there is significant management commitment, in-depth and continuous 83 training of personnel, and permanent supervision to ensure that the prescribed practices are being followed. Otherwise, there is always a risk that infectious and hazardous materials will enter the common waste stream. Hospital waste is the gruesome by- product of disease control and of modern medicine. Blood-caked needles, body parts, acrid bandages and other infectious waste pours, often unchecked, out of the hospitals every day. The only solution is a safe waste-disposal technology. Developing infrastructure for hazardous waste management at each laboratory. This will be done as part of the program allocation for individual participating laboratories. Combining strategy to dispose hazardous waste generated from laboratory with general hospital waste. This would be part of a district waste management scheme and IDSP will link up with the existing system in the districts of operation. Will encourage efforts in the development of private / public systems for hospital waste disposal and enactment of appropriate legislation so that this becomes mandatory for all health care delivery sites generating bio-hazardous wastes. 23 INFORMATION TECHNOLOGY IN IDSP At present, the state, district and block level units of IDSP have telephones connections or can easily obtain the same, since connectivity can be obtained on demand in states like Tamil Nadu and Maharashtra. This includes, CHC / Block PHC, District Surveillance office, District Public Health Lab, State Surveillance office and state level laboratories. There are no telephone connections available at PHCs / Addl.PHCs. Transfer of information on disease outbreaks can be quickly passed on from Block level PHCs to District Surveillance office. Current advanced technology is to be used for the computing and communication needs of the program. It is proposed to provide connectivity initially up to District level. Connectivity to CHCs would be taken up on a pilot basis, before replication of the same at CHC level. Computers for data entry and receiving inputs from the district level would be available at the periphery. Peripheral data entry units will dial into the dedicated server at the district surveillance center for sending and receiving surveillance information. At the district level, it is proposed to develop a dedicated surveillance network linking all districts of the country. Back up of local data at the district will be available at District Server, in case of data loss at the Central database. Regular back up of local data will be taken in CD ROMs for storage. The district surveillance officer will do basic analysis of data at the district level, in addition to sending reports of the compiled data to the state surveillance unit. The state surveillance unit will perform all advanced analysis and regular feed back reports will be provided to the district and participating peripheral centers. 84 The network is expected to exist on the following levels: CHC/Primary Health Center (Level-1) (Pilot Basis) District Health Office (Level-2) State Health Directorate (Level-3) Directorate General of Health Services (Level-4) Full vertical and restricted horizontal access for data will be provided in the program. The network will be efficient in terms of data entry, personnel requirement, training needs, data transmission, possible damages and costs. 23.1 Proposed IDSP information technology infrastructure and networking Information flow in Integrated Disease Surveillance Program is as depicted in the figure given below. Redundancy is built into the system at the server level. There is provision of a Server with hot swappable hard disks at District level alongwith three client machines. There is also a provision of a (Remote Access Server) RAS which would enable peripheral units to dial into the server and transfer the data. The district units would have the ISDN/dedicated connectivity to enable them to transfer the data to State and Central servers. 85 Rural Channel Disease Surveillance System -Information Flow Health Worker and Nurses Sub Centre Urban Channel Health Worker and Nurses Sanitary Workers PHC with Medical Oficer Rural Lab Channel Health Inspector Block Hospital/ CHC / BLOCK PHC with Civil Surgeon and Medical officers District Health Officer Information from National Programs $ DDHS / DDHS National Program District Hospital with Chief Medical Officer Wards Urban Lab Channel Block Laboratory Zonal Laboratory District Lab Corporation Lab Medical Colleges State Private Channel Private Practitioners Zones Municipal Corporation Private Nursing Homes Private Hospital $ State Private Agencies/NGOs State Laboratory National Unit DHS 86 State Server WAN Link to adjacent State Modem Client 1 Switch Router Client 2 Switch Modem WAN Link to adjacent State Client n 29.2 State Network Configuration 87 The all-India WAN design will involve a trade-off between cost and fault-tolerance. One strategy is to setup a partially-meshed network of links such that there are at least two independent paths between any two adjacent states. An example of this is given below: Fig 9. State 1 State 3 State 2 State 4 Note that no single link failure will cause transmission failure. Also, note that the link from State 1 to State 4 is not strictly necessary but provides extra fault tolerance. The infrastructure for the system will include: State Servers: Each server will need to run Operating System, Database and Analysis Server and the Data Entry and Analysis Application. It is expected that the maximum amount of data storage requirements per state per year will not exceed 15 GB. Taking all these factors into account, and allowing for future growth in the number of clients that must be supported, the following configuration is recommended for each State server: 23.2 IT Infrastructure for IDSP 23.2.1 System Software and Packages:23.2.1.1 Operating System: An appropriate Operating System will be required on every PC/ Server machine at Centre, State and District levels. The operating systems at various levels, for client and server machines, should be a userfriendly OS, providing secure and stable environment, as per operational needs at each level. It should support all the prevalent and desirable functionalities of a modern day operating system, including – all type of networking/ protocol features, virus/ intrusion protection, crash-proofing and system recovery features etc. For clients, it could be Windows XP or Linux or similar other Operating System and for servers, Windows 2K/ 2003, Unix or Linux Server version or similar other Operating 88 System, matching the needs of the integrated IDSP application finalized (yet to) for implementation at respective levels. 23.2.1.2 RDBMS: Similarly, the need of RDBMS package will also vary at various levels, but it should be a widely used and supported RDBMS, with all present day features of file/ record handling, authentication, concurrent access, ODBC support etc The options may be --- Oracle, SQL Server, DB2 or similar other package, matching the needs of integrated IDSP solution finalized. For small volume/ versatility needs at Client level, MS-Access or similar other Linux based package may also suffice. 23.2.1.3 Application Support/ Development Platform and GIS/ other tools: The choices for the application support/ development platform and tools will completely depend on the needs of the Integrated IDSP Application solution and the vendor’s approach to the solution development. But with given intent of implementing Web based solutions at every level, largely the requirements will confine to Web Servers/ Web Authoring & Site management tools and GIS/ data-analysis tools at State and Central levels, apart from a Web browser required on every PC. The options could be ASP/ .net or JAVA based development, with Web service tools like IIS/ Front Page, IBM Web-sphere etc. and GIS/ statistical packages like MapInfo etc at State/ Central levels. 23.2.2 Hardware and Networking: 23.2.2.1 District Level District Surveillance Unit One lower end server (512MB RAM, min. 2x18 GB hot swap HDD, SCSI controller, CD/Tape Back-up, NIC etc.), with RAS, for multiple (up to three) dial-in access to the server. Two Client PCs (P-IV 2.4 GHz, 256MB RAM, 40 GB HDD, CD/DVD Drive, NIC etc.) on LAN, supporting at least 4-5 extra ports for connecting more PCs. One Dot matrix and one Ink-jet printer, UPS 1 KVA with two-hour back up Clients Three Client PCs (similar as above) with dial-up modem, printer (DMP/Ink Jet) and UPS (500 VA 30 Min. backup) for Dist. Level Govt. institutions. 89 Connectivity ISDN/dedicated connectivity, at least 64 Kbps, through ISP or NICNET (NIC District Unit), Provision for Stabilized and continuous power supply. 23.2.2.2 State Level State Surveillance Unit Two Mid Range Servers (Dual Xeon processor, min. 1GB RAM, min. 2x36 GB Hot swap HDD, SCSI/RAID controller, CTD Back-up, NIC etc.) for Web services and Database, Three Client PCs (similar to districts) on LAN, supporting at least 8-10 extra ports for connecting more PCs, One Dot matrix, one ink-jet printer, one Laser-jet printer and one scanner UPS 2 KVA with two-hour back up Clients Five Client PCs (similar as above) with dial-up modem, printer (DMP/Ink Jet) and UPS (500 VA 30 Min. backup) for State level Govt. institutions/ Labs Connectivity ISDN/dedicated connectivity, at least 128 Kbps, through ISP or NICNET (NIC State Unit), Provision for Stabilized and continuous power supply 23.2.2.3 Central Level Central Surveillance Unit Two Mid Range Servers (Dual Xeon processor, min. 1GB RAM, min. 2x36 GB Hot swap HDD, SCSI/RAID controller, CTD Back-up, NIC etc.) for Web services and Database, Three Client PCs (similar to districts) on LAN, supporting at least 8-10 extra ports for connecting more PCs, One Dot matrix, one ink-jet and one LaserJet printers, one scanner UPS 2 KVA with two-hour back up Clients Ten Client PCs (similar as above) with dial-up modem, printer (DMP/Ink Jet) and UPS (500 VA 30 Min. backup) for State level Govt. institutions/ Labs Connectivity ISDN/dedicated connectivity, at least 128 Kbps, through ISP or NICNET (NIC Hqr Unit) Provision for Stabilized and continuous power supply 90 Similar to Central IDSP Directorate, a similar set-up at National Institute of Communicable diseases (NICD) and may be ICMR, are also envisaged, so that they are fully equipped to support this activity. 23.3 Software licenses The number of licensed software that will be required for the project, and the total licenses required for the whole of India is given below. SOFTWARE LICENSES Software Server Operating System Database and Analysis Server Messaging Server Server Monitoring Desktop Operating System National Level 2 2 1 1 10 State Level 2 2 1 1 5 Distric t Level 1 1 1 1 3 23.4 Administration This will include security, network, database, and server administration. 23.4.1 Security administration Secured Application with secured mailboxes are to be deployed to manage users and groups. User sessions will be logged and input data will be tagged by session identity to allow audit. 23.4.2 Network administration An exclusive IP address range will be allocated to each state. Client machines and other data producers will be assigned static IP addresses in this range. Other client machines will be dynamically assigned IP addresses in the given range at login time. 23.4.3 Database administration Database administration will involve setting up replication and recovery procedures. 23.4.4 Server administration Servers deployed at the State and District will be monitored and administered remotely. An application will be developed for monitoring the health of the network components, servers, and main clients of the system with provision for alerts to be issued to appropriate personnel. 91 23.5 Failure and disaster recovery Redundancy will be built into the system at the server, network levels so that there are no single points of failure. High-quality hardware components will be purchased, and hardware service agreements guaranteeing low mean time to repair will be entered into. The effects of various types of failures is discussed below. 23.5.1 Server failure When a server in the state fails, the other server will automatically replace it. The hardware maintenance company must repair the machine or provide a replacement within a day. Fitting the new server with software and data can be done within stipulated hours. 23.5.2 Network failure When a link in the network fails, the duplicate network link will automatically takeover. The hardware maintenance company must repair the network within a day. 23.5.3 Inter-state network failure If one of the WAN links between two adjacent states fails, the other will take over. If both WAN links fail, inter-State data transfer will stop. The hardware maintenance company or the responsible party must agree to repair the link within a day. 23.6 Computer virus attack The approach used here will be to prevent rather than cure viruses. Normal users of the system will not have the rights to install applications on client machines, and will not be able to access the server except through the application. There will be no CD-ROM or floppy drives on client machines. Sharing of folders will not be allowed on client machines. If there is suspicion of infection on a client machine, the machine will be immediately replaced with a standby machine and repaired. Repair will consist of formatting the hard disk of the machine and reinstalling all software. The server will also be hardened against the possibility of virus attacks by shutting down unnecessary services, and restricting access by clients to inter-process communication. 23.7 Management of total computer failure If the data in a state is completely lost for whatever reason, it can be built back up from the database replica at an adjacent State Server. This can be done within one day of the restoration of the hardware and other infrastructure of the state. 24 TRAINING NEEDS IN IDSP Integrated Disease Surveillance Program envisages to have a action oriented district centered, decentralized surveillance program established in the country. Human Resource Development is one of the important components of the program. 92 The following key issues underlie the development of the Training strategy and Plan IDSP doses not intend to employ additional staff considering the financial position of the states and long term sustainability Existing personnel will be provided training to undertake surveillance activities more efficiently integrating even non-health workers for this activity if necessary. As far as possible training will be provided locally at the sub-district level, some at district and few at state and at the center Public private partnership is an important component in IDSP both in terms of training provider and the trainee. Current method series mode of training and training of trainers has not been able to provide good quality training and this will be taken into consideration in the development of the training strategy for IDSP. 24.1 Training Needs Assessment: An assessment of training needs was carried out in 6 states in India to understand the available infrastructure, human resources and perceived needs of the program in terms of human resource development. The key inferences that emerged from this assessment were as follows: Training and sensitization workshops for IDSP activities is essential for the successful implementation of the program. There is a wide variation in the training needs and available infrastructure between different states. While some of the states have established training centres and good medical colleges, the training infrastructure (including human resources) in other states leaves much to be desired. The male health workers are not being re-employed in most states and only 30-50% of available posts are occupied. Over the next few years more vacancies are likely to be present in this category. Qualified microbiologists even at diploma level are not present in the public health system in most states for working in the district public health laboratories envisaged in the program. 93 Staff trained in Public Health are very few, especially at the District level and above. This means that the training in surveillance needs to be imparted to all the relevant personnel, including the district and state level officers Duration of training for IDSP should be short and it is not possible to spare health workers and doctors for more than 2-3 days at a time. Consultant service at State level would be required at least for the first 2 years to effectively implement the IDSP activities in addition to training of personnel. User friendly training manuals should be made available. Based on training needs following matrix gives recommended curricula : Training Feedback Supervision and Monitoring Research Response Lab confirmation Analysis Case detection Overview TABLE : RECOMMENDED TRAINING CURRICULLA FOR EACH LEVEL Central and State Nodal officers ++ ++ ++ ++ ++ ++ ++ ++ ++ Select Medical College trainers ++ ++ ++ ++ ++ ++ ++ ++ ++ Corporation Health Officers ++ ++ ++ ++ ++ ++ ++ ++ ++ State EIT members ++ + ++ ++ ++ + - + ++ SIHFW staff ++ + ++ ++ ++ + - + ++ District Nodal Officers ++ ++ ++ ++ ++ ++ ++ ++ ++ District EIT members ++ + ++ ++ ++ + - + ++ District Statisticians + + + - - - + - + District Lab technicians + + + ++ + - ++ - + District HFW Trg centers ++ ++ ++ ++ ++ ++ ++ - ++ SPM and Microbiology Depts of Medical Colleges ++ ++ ++ ++ ++ ++ ++ ++ ++ State Directorate, State Epidemiologists, Entomologists, State Statisticians. ++ - - - - - - - - MHO ++ ++ ++ ++ ++ ++ ++ - ++ 94 Pediatric, Medicine and Emergency Dept. of Medical colleges ++ + - - - - - - - MPs, MLAs, Mayors, Commissioners ++ - - - - - - - - Private representatives ++ + - + - - - - - DHO, District Programme managers, DMO, District Hospital Physicians, Pediatricians ++ + - + - - - - - Officials of other Depts. + - - - - - - - - MO – PHC / CHC, urban dispensaries, MHO ++ ++ ++ ++ ++ ++ ++ - ++ Sub block staff ++ ++ - - - - - - - Community representatives ++ - - - - - - - - 24.2 Training Strategy: Induction Training prior to initiating the program. Continued training • On-the-job supervision and training • Web based training – credit system • regular refresher training • Annual peer interaction - CME 24.2.1 The Sensitization Workshops The sensitization workshop is essential to make the program but this is considered in detail under social mobilization and not being considered as part of training. Short half a day to 1 day sensitization workshops will be conducted as part of IEC activities to make stake holders aware of the IDSP and ensure their participation in the program at different levels. These workshops are seen differently than training and is dealt with in the IEC section. The groups which needs sensitization are mentioned below: 1. State Level – Policy makers and administrators at state, district including Health secretaries, secretaries of related sectors. Heads of departments of medical education and health services. Medical college principals, District collectors, 95 2. District Level - NGOs doing and interested in disease surveillance. Representatives of Indian Medical Association (IMA) and Indian Association Paediatrics (IAP). 3. Block Level - Panchayat leaders, School teachers, Anganwadi workers, Sentinel private practitioners and Medical practitioners of alternate systems of medicine alike aurveda, unani, homeopathy and un registered practitioners in the locality. 24.2.2 Types of Induction Training Programs: There are 8 separate training programs planned under the program to meet the needs of the following groups of personnel in the program. (a) Training of the State and District surveillance teams – The trainers (b) Training of the Medical officers – The primary efferent arm of the project (PHC / CHC / Urban Health services / Medical colleges) (c) Training of the Medical officers – Important affarent arm of the project (Private Sector hosptials, Including SSPs, MC, others) (d) Training of the Peripheral workers – The work horses (MPWs, ANMs, Health supervisors, NGO field workers etc) (e) Training of Microbiologists and Lab technicians (State and District level) (f) Training of Lab technicians (Sub District level) (g) Training of Data entry operators (State, District and Sub District level) (h) Training of Data Managers (District and State level). 24.3 Who will provide the training The training plan was developed so that the training provided will meet the high quality required for IDSP to function effectively. It also took into account the loss in quality with standard series mode of training. Three levels of trainers were identified: Level-1 Trainers Level-2 Trainers Level-3 Trainers 24.3.1 National Network of training Institutions – Level 1: The responsibility of training in the program will be with a network of national institutions selected on the basis of definite criteria. These institutions will take the responsibility for training state and district surveillance teams coordinated by the central surveillance unit functioning under the ministry of health and family welfare. These will be the Level-1 Trainers. 96 A Consortium of institutions may also qualify for with established memorandum of understanding on the roles and responsibilities. A total of 30 institutions will be chosen which would focus on training in surveillance activities, and specific laboratory training. Institutions specialised in epidemiology and surveillance activities may be chosen, even if they do not have training facilities in laboratory. In such cases the State would have to choose a separate institution for training in laboratory activities. The Central Surveillance Cell would short list the 30 institutions based on certain criteria. The State Surveillance Unit would be free to chose the appropriate ones for their state. Some of the criteria proposed for choosing a Training Institution are as follows: Criteria: Epidemiology Training center a. Recognized training institutions with experience in post graduate teaching in the field of community medicine/ Public health, and microbiology b. Adequate training infrastructure and equipments, , c. Key resource person in the area of epidemiology, microbiology, medicine and paediatrics who are willing to be resource person for training if selected d. Preferably, experience in health surveillance activities Criteria for Laboratory Training: 1. Training institutions with experience in the field of microbiology 2. Adequate training infrastructure and equipments, , 3. Key resource person with expertise in the filed of microbiology who are willing to be resource person for training if selected 4. Preferably, experience in health surveillance activities Criteria for Institutions for training in data management: 1. Institutions with prior experience in training in data management 2. Adequate training infrastructure and equipments, 3. Key resource person with expertise in the field of statistics and data management who are willing to be resource person for training if selected 4. 4. Preferably, experience in health surveillance activities 24.3.2 Level -2 Trainers: The level 2 trainers would be members of the district and state surveillance team who have been trained by the Level 1 Trainers. They would take the primary responsibility of training the district and sub-district personnel (Category II, III and V trainees). 97 24.3.3 Level 3 Trainers: These would be the Block Medical officers who would in turn train the Sub Block staff (Category IV trainees). 24.4 Quality Assurance: Mixed model series and parrallel mode of training is planned for the program so that loss of training quality in series mode is minimized. 25% faculty for Health worker training at the sub-district level will be from state and district surveillance team (2 levels higher) 25% of the faculty for district Level training will be from the selected national institutes of training Independent external evaluation of training is an important component Determine the continued funding for training by the institutions and groups The trainees for the induction training are given below: Table : THE TRAINEES1 Category Level I State and District level Surveillance Teams II Medical Officers Trainees State Surveillance Officer (SSO), State Programme managers, State Microbiologists / Lab technicians and State level Data Managers District Surveillance officer, 2 District programme Managers, District Microbiologist / LT and District Data Managers RRT members Numbers 10 per state Medical Officers of the PHCs, CHCs and Urban Health sector. MOs of the SPM departments of local Medical colleges. MOs of NGOs / Mission Hospitals 70 per district 10 per district 1 Nodal Officers: It is clarified that nodal officer/District Surveillance Officer at district level does not automatically imply the DHFWO but should be the officer who is actually involved with the programme and would usually be a Dy DHO/ Dy CMO/ Programme officer dealing with surveillance. S/He should preferably be a specialist in public health 98 III Clinical Medical officers IV Sub Block staff V State and District Level Laboratory training VI VII Sub District Level Laboratory training Data entry operators VIII Data managers Medical Officers of the Hospitals, Subdistrict Hospitals, Medical College Hospitals, SPPs, MPWs (Male / Female), Health Supervisors, NGO volunteers, unregistered Medical practitioners State and District level microbiologists / LT. Also of the urban health sector. Also Microbiologists from local Medical Colleges PHC / CHC / Urban dispensary LTs DEOs at CHC, District and state level Statisticians at District and State level 30 per district 350 district 5 per district 5 per district 15 per district 2 per district 24.5 Site of Training: Maximum time that personnel at district and sub-district level can be spared is 2-3 days. This means that most of the training is district and sub-district level itself. Training will be preferably at one level higher than the working environment I II III. IV TRAINEES District and State Surveillance team Medical Officers of the PHCs, CHCs and Urban Health sector. MOs of the SPM departments of local Medical colleges. MOs of NGOs / Mission Hospitals Medical Officers of the Hospitals, Subdistrict Hospitals, Medical College Hospitals, SPPs, MPWs (Male / Female), Health TRAINERS Level 1 – Selected National Level Training Institutions Level 2 – State and District Surveillance Team Site Regional / State District HQ Duration 6 days District HQ 1 day CHC 2 days 3 days Support from Level 1 Trainers Level 2 – State and District Surveillance Team Support from Level 1 Trainers CHC Team with selected MO PHCs. Support from Level 2 99 V VI VII VIII Supervisors, NGO volunteers, unregistered Medical practitioners State and District level microbiologists / LT. Also of the urban health sector. Also Microbiologists from local Medical Colleges Training for lab assistants at CHC / PHC Data entry operators Data Managers district Trainers. Level 1 trainers - Identified training institutions Regional / State 6 days District Public Health laboratory staff Representatives from Level-1 institutions Soft ware agency Identified training institutions District HQ 3 days District HQ Regional/ state 2 days 3 days 24.6 The Training Curricula The training curricula for the IDSP would be focussed mainly on surveillance activities. While all the staff would get an overview about IDSP, the stress would be on the practical aspects of the programme that apply to their level, rather than esoteric epidemiology principles. The basis for the IDSP curricula would be the Operational manual. I Trainees Training of district and state Surveillance teams Content of Training Overview and introduction to surveillance with special reference to IDSP. Basic epidemiology pertaining to surveillance including definitions like rates, ratios, IR, PR, CFR, spot maps, graphs etc. Details of case detection, including case definitions, reporting units and filling up forms, compilation and transmission of data Collection and transmission of laboratory specimens and bio-safety issues Details of analysis and Interpretation of data Details on Response to outbreaks Supervision Monitoring and Evaluation . Feed back Training methodology Inter-sectoral coordination 100 II Medical Officers of the PHCs, CHCs and Urban Health sector. MOs of the SPM departments of local Medical colleges. MOs of NGOs / Mission Hospitals Overview and introduction to surveillance with special reference to IDSP. Details of case detection, including case definitions, reporting units and filling up forms, compilation and transmission of data Collection and transmission of laboratory specimens and bio-safety issues Basics of analysis and Interpretation of data Details on Response to outbreaks Supervision Monitoring and Evaluation. III Medical Officers of Overview and introduction to surveillance with special the Hospitals, reference to IDSP. Subdistrict Details of case detection, including case definitions, Hospitals, Medical reporting units and filling up forms, compilation and College Hospitals, transmission of data SPPs, Basics of lab confirmation – what specimens to be sent to which lab, and in what manner for confirmation Trainees Content of Training IV MPWs (Male / Overview and introduction to surveillance Female), Health Syndrome description Supervisors, NGO Filling up of forms volunteers, Transmission of data unregistered Medical Collection of specimens practitioners Biosafety issues Basic response to outbreaks V State and District Overview and introduction to surveillance with special level microbiologists reference to IDSP / LT. Also of the Hands on training on diagnosis of specific diseases. urban health sector. Especially Culture and sensitivity of stool and blood, Also Microbiologists Serology etc. from local Medical Quality assurance mechanisms Colleges Biosafety issues VI Training for lab Introduction to IDSP assistants at CHC / Testing for sputum AFB, Malarial smear, Typhi Dot test PHC Collection, storage and transportation of specimen Biosafety issues VIII Training for data Introduction to IDSP management at Extracting of data from the computers district and state Analysis of data level 101 24.7 Training Plan Trainers Level 1 (30 institutions) Level 2 (230 districts) Trainees State and District Trainers 30x 9 states W1 MOs of PHCs / CHC etc 70x230 districts (16100) Totally 60 – 70 trainees per district One training team per district 3 batches of 3 days each An average of 2 weeks Totally 30 trainees per district One training team 2 batches of 1 day each. MOs of Hospitals 30x 230 (6900) Level 3 (230 districts) Level 1 (30 institutions) Level 2 (230 districts) Level 1 MPWs etc 6x4x15x 230 (82800) State / District Trainers Lab 2 x 30 x 9 LT of PHC / CHC 10x 230 W2 W3 W4 W4 W5 W6 W7 W8 W9 W10 Totally 2700 trainees in 9 states. 30 Training institutions An average of 90 trainees per training institution 3 batches per training institution –30 trainees per batch One week training per batch 20 – 30 trainees per block One training team per block 1 batch of 2 days each ~550 trainees 20 training institutions – an average of 30 participants per institution 1 batch per institution – of I week 10 LTs per district One training team One batch per district of 3 days Data ~460 trainees Management 20 training institutions – an 2x 230 average of 25 participants per institution 1 batch per institution – of 3 days 102 24.8 Integrating existing public health training programs for training Currently there are a number of training programs in public health organized by different organizations in the country. These are: Two years Masters in Applied Epidemiology - NIE Three months FETP - NICD Ten day Epidemic preparedness and response - NIE / NICD Ten days Training of RRT - NICD Ten day Training on Computer Applications - NICD Two year MPH course - SCT – Trivandrum Three year MD course in PSM - Selected Medical colleges 15 days course on Basic Epidemiology - CMC, Vellore Two year MSc in Epidemiology - CMC, Vellore Two year MPH at TISS - Mumbai These are the various training programmes that are already existent and the IDSP can use some of them to train their staff as well as utilize the materials already available. 24.9 Institutional capacity to undertake training in different states There are some medical colleges that have existing public health departments and trained epidemiologists and can be used for training purposes. Some of these are: PROVISIONAL LIST OF MEDICAL COLLEGE/INSTITUTIONS AIIMS – Delhi MMC – Chennai AIPHH – Kolkata CMC – Vellore NICED – Kolkata NIMS – Hyderabad NRS Medical College – Kolkata SJMC – Bangalore GMC – Guwahati MIMS – Manipal SGPGI – Lucknow TMC – Trivandrum PGIMER – Chandigarh SCT – Trivandrum CMC – Ludhiana JIPMER – Pondicherry IIHMR – Jaipur INDIACLEN network of Medical colleges AFMC Pune TISS – Mumbai BJMC Pune NIE – Chennai Grant Medical college – Mumbai NICD – New Delhi NIHFW Other than these, there are other medical colleges which can play an important role in training at sub-district levels. 103 24.10 Conclusion: Total of ~112,000 personnel of different category will need to be provided training during the induction phase of the Integrated Disease Surveillance Program. Even though the magnitude of this training is very large. The phased induction of the program will make it feasible for the induction training to be completed in time frame of 3-6 months time to cover 9 states considered for the 1st phase of the program. Most of the personnel will be provided specific training for performing the tasks for IDSP at subdistrict and at the district level and the duration for district and sub-district level training will be short (2-3 days only) The quality of training can be assured by developing a mixed model of series and parrallel system where core trainers are represented in the lower order training sessions and having random external evaluation and feed back to the system Retrospective financing allowed in the program will make it feasible for the state and central governments to initiate components of training even before the World bank financing is made available. 25 SOCIAL MOBILIZATION AND COMMUNITY PARTICIPATION Disease surveillance cannot be sustained unless the community stakeholders support the data collection and the health system recognizes them as true partners. Therefore, a well planned social mobilization strategy will have to be put in place to obtain valid and reliable data with high sensitivity. 25.1 Current involvement of community In areas where health workers enjoy a good relationship with their communities, people come forward and volunteer the desired information. Several health workers are in regular contact with village elders’ particularly ladies, pradhan, panchayat members, chauwkidar and other community members who tell them about the occurrence of diseases. Current efforts are based on individual initiative taken by some enthusiastic health staff. However there is no institutionalized system of involving the community in health programs including surveillance activities. In addition, the community consistently expected to get feedback about the activities and data collected by health workers. When no feedback is given to the community, the people consider the whole exercise as part of the health worker’s job responsibility which was irrelevant and of no benefit to them. The community members, press, and local leadership often give information about epidemics. There are rumor registers kept in PHCs and sub-centers. Thus community is already contributing significantly in the current efforts of disease surveillance and detection of outbreaks. 104 25.2 Socio-cultural issues to be taken up for social mobilization campaign There are several socio-cultural barriers prevailing in the communities across the country that influence the sensitivity of data collected for surveillance activities. Social mobilization campaign in IDSP will need to address all diseases associated with sociocultural beliefs. Details have been provided in section 3.1.2 Religious minority groups in some areas are suspicious of the government health systems and hence withhold information. Urban clients staying in high-rise buildings do not wish to utilize public health services and therefore are non-cooperative even for surveillance activities. Due to poor credibility of health systems, many clients consider surveillance activity is meant for health departments with no benefit to common people. Tribal and rural women felt that doctors in public sector health facilities do not provide good care because they are poor. Local leadership may sometimes refuse to support public health activities including surveillance if these hurt their personal interests. 25.3 Gender Issues in Surveillance Focus group discussions with women in tribal, rural and urban areas consistently brought out the gender disparity in seeking health care. Gender disparity would seriously influence the validity of currently available surveillance data. Details about the perception on this issues are provided in section 3.1.3. 25.4 Stakeholder who can be involved All those individuals and organizations that operate as an interface between the health system and the community will be identified as community stakeholders. The stakeholders will be involved proactively during the planning and implementation phase of IDSP. To meet these objectives, the stakeholders will be made members of the district surveillance and block surveillance committee. The proposed list of stakeholders is provided under ensuing subsections. 25.4.1 Rural areas Panchayat and its members; school teachers; community based organizations e.g. mahila mandals and youth clubs; NGOs working in health areas; elected representatives from the area; private rural practitioners. 25.4.2 Urban areas Municipal councilors; representatives of professional bodies e.g. IAP, IMA, API; NGOs; chemists organization; leading private practitioners and owners of hospitals / nursing homes. 105 25.5 Social mobilization strategies The aim of the social mobilization campaign under the IDSP will be: To create awareness among the partners, notably the private practitioners, NGOs and the community about existing health programs, IDSP, the potential benefits, areas in which their participation will be solicited To establish an institutional mechanism to involve community and their leaders Develop a system of providing regular feedback to the community about disease occurrence, the responses to surveillance and impact of disease control programs IEC must address all the issues that are likely to improve the sensitivity of the surveillance data, particularly the prevalent socio-cultural beliefs and gender disparities To increase the reach of the campaign, all channels of communication are to be used; these will include electronic media, press, hoardings, hand bills, posters, and interpersonal communication through health providers at all levels Content and messages of the campaign targeted at health workers and private practitioners will be different from that meant for the community, panchayat members, local influential persons and NGOs. In view of the above, resources will be required for following activities: Central Level: Organizing a media campaign for creating mass awareness about the usefulness of the surveillance, about core disease surveillance, dispelling common socio-cultural beliefs and gender disparity Sensitization and mobilization meetings for central and state level functionaries of IMA and other professional bodies to solicit their support for the program Some IEC material for health functionaries and selected sentinel private practitioners, highlighting technical issues State Level Organizing a media campaign for creating mass awareness about usefulness of the surveillance, about core and state specific disease surveillance, dispelling common socio-cultural beliefs and gender disparity Sensitization and mobilization meetings for state and district level functionaries of IMA and other professional bodies, medical colleges, NGOs involved in health, to solicit their support for the program IEC material for health functionaries and selected sentinel private practitioners highlighting technical issues IEC material and messages to be prepared within the local context and in the locally comprehensible language Bring out periodic reports on surveillance data and the consequent responses by the health department as feedback to the community and local leadership 106 District Level and Periphery Organize sensitization and mobilization meetings at district head quarters for local IMA executive members, prominent practitioners, NGOs in health, elected representatives of the local as well as state bodies, district panchayat board members, teachers IEC material and messages to be prepared within the local context and in the locally comprehensible language; put up hoardings, posters, distribute hand bills to create wide spread awareness. The IEC material has to be displayed in schools, all sentinel sites, prominent locations in the village and busy street crossings in urban areas, and in all places where mass human gatherings occur e.g. festivals, melas, exhibitions At village and block level: organize meetings between medical officers of the area, health workers and village health committees once in three months, with the purpose of revitalizing this institution, enhance community participation in all health related matters and identifying the community as partners in the planning and decision making process. 107 PART – V QUALITY ASSURANCE 108 26 QUALITY ASSURANCE IN IDSP Assuring quality in IDSP activity is of primary importance. The quality of data must be valid, reliable and timely to serve as an effective tool in health decision-making (to serve as an effective tool in health decision making). To ensure quality in the program the following factors have been incorporated: 1 Restricting the total number of diseases to be kept under surveillance based on priority and thus preventing overloading the peripheral staff. 2 Proving training to all the essential staff of the program as specified in the training section. These include: a. Induction training b. On the job training for the 1st 4 years of the program to all the stake holders. 3 Using information technology optimally in data entry and analysis. The large number of reporting units in the periphery will make the quality of data unreliable unless IT is used. Computer entry of data has been introduced till the block PHC level. Timeliness of transfer of information will also be assured by this process. Details are included in the IT chapter. 4 Development of Field Manuals for the program is of crucial importance to ensure quality of surveillance. These will be user friendly and in local languages to enable the field staff to utilize these for standardization and training. 5 Supervision will be a continuous process at all levels to maintain quality. 6 Monitoring, evaluation and feedback have been built into the system to improve on the activity as the program evolves over time. 7 External evaluation will be mandatory and this will be used to facilitate mid course corrections in the program. 8 External quality control programs exist for all participating laboratories. 9 A system of accreditation has been developed for participating laboratories. One of the objectives of the component on laboratory support is to improve the quality of laboratory services, particularly as they relate to the health conditions under surveillance. The laboratory data are used to increase the specificity of diagnosis and verify the cause of suspected outbreaks. As the current quality of laboratory activities across districts and states is unknown it will be necessary to conduct a baseline survey of the quality of laboratory services for the diseases under surveillance in the first year of the project. The survey results will form the cornerstone and basis for a comprehensive external quality assurance scheme (EQAS) to be implemented during the project. 109 EQAS is evaluation by an outside agency of performance by a number of laboratories on specially supplied samples with the objective to achieve between-laboratory or between-method comparability; if these specimens have been analyzed with a reference preparation, estimates of accuracy can also be made. Such external assessment is essential for maintenance of quality standards in laboratories. This external assessment should be complemented by laboratories' internal evaluation through internal quality control and standardization of procedures. The laboratory network for IDSP will be established at five levels of functions: 1. 2. 3. 4. 5. Peripheral Laboratories and Microscopic centers (L1 Labs) District Public Health Laboratory (L2 Labs) Disease Based State Laboratories (L3 Labs) Regional Laboratories IDSP and Quality control Laboratories (L4) Disease based reference Laboratories (L5) The activities to be undertaken at each level in this laboratory network are as shown in the Tables 1 to 3 below: Table 1. Activities to be undertaken in Peripheral Laboratories PHC Laboratory / Tuberculosis Sputum AFB smear Collect random sample of Sputum for Culture at L3 Lab Confirms 0.5% Malaria Typhoid Blood smear for Malaria Rapid diagnostic test (Typhi Dot) Collect blood for culture at L2 Level Confirm 0.5% Confirm 0.5% Water Quality Kit for chlorination test Rapid test kit for fecal Contamination collects random sample of water for colony count at L2 lab Confirms 0.5% Confirms 0.1% Cholera Collect random sample of stool For testing at L2 lab 110 Table 2 - Activities to be undertaken by the District Laboratories Conditions Test Confirmation Tuberculosis Sputum AFB Smear Confirm 1% (both +ves and -ves) from Peripheral Labs Malaria Blood smear Confirms 1% from Periphery Typhoid Rapid Diagnostic test and Blood culture Confirms 1% Typhi Dot tests positive samples Blood culture on 1% of suspected typhoid Cholera Stool culture Cholera Toxin Test ADD Stool culture confirmation in 0.1% of suspected cholera 1% of samples from periphery Colony count tested in 5% of samples Water Quality Chlorination tests and colony count Additional Tests Rapid test for fecal contamination Table 3 - Activities to be undertaken by State Laboratories Test Conditions Test AFB Culture and Sensitivity Confirmation Objective 1. Tuberculosis Perform 1% of positive culture from district level Identify magnitude of MDRTB 2. Malaria 3. Typhoid Sensitivity Testing in S.typhi isolates Confirm 1% of bacterial isolates at District Level Pattern of AMR for S.typhi typing 4. Cholera Cholera culture and typing 1% of Cholera isolates from districts Identify pattern of bacterial infection Confirm 1% from districts Cholera toxin test 5. Water Quality Colony count 6. NCD surveillance Blood sugar, HDL, LDL Risk factor surveillance for NCD 7. Polio Follow present procedures Confirm Polio 8. Measles Kit for Measles IgM antibodies Confirm Measles 9. Leptospirae MAT Test for Leptospira Confirms 0.5% from district levels Confirm Leptospirae 111 10. Dengue IgM test for Dengue Confirm Dengue 11. Hepatitis Serology for Hepatitis A, E, B, C 12. Anthrax Identification of Anthrax Confirm Anthrax 13. Plague Identification of plague Confirm Plague Confirm 1% of samples from district Quality control Hepatitis work Study Tasks: The Survey Organization selected for EQAS is expected to carry out the following tasks which should be addressed in the proposal: Prepare a detailed protocol for undertaking the survey including the overall approach to the assessment of laboratory quality in a cross-sectional survey, survey methodology, survey instruments, sample design, and sample size Details of the manner in which quality of the specific laboratory tests will be made. Pre-test tools and questionnaire Carry out the survey Data entry and analysis Outline of report Schedule of work through submission of the final report 26.1 Supervision Supervision is a process of helping health staff to improve their work performance. Supervision is not an inspection. The aim of the supervision will be to develop a good system wherein supervisors and health professionals work together to review progress, identify problems, decide what has caused the problem and develop feasible solutions. Supervision will include following components: - Specific job descriptions that to include surveillance tasks relevant to each category of health staff. - Preparation of a supervision plan. - Conducting supervisory visits. - Preparation of a supervisory check list. - Preparation of a report of the supervisory visit. - A check list of supervisory activities will be developed at every level to facilitate the process. Supervision will be facilitatory rather than a policing mechanism. 26.2 Monitoring and evaluation All surveillance activities will be continuously monitored and supervise using pre-defined indicators. Process and performance indicators for response and management will be developed for the project. This will ensure building an effective monitoring and supervisory system with emphasis on developing high quality of surveillance activity in IDSP. The data from monitoring 112 and evaluation will be used to effect appropriate response mechanisms and conduct mid-course improvement in the program. The objectives of monitoring will be to assess: 1. 2. 3. 4. 5. Timeliness and completeness of reports Responses and action taken. Delay between onset and identification of epidemics outbreaks. Supervisory activities. Actions/steps taken to modify/improve/IDSP are on the basis of data, reports and analysis. The monthly meeting of the health staff responsible for surveillance at the health facility at the district level will review and analyze the data reported during the month. Disease outbreaks and the response of the health system will also be reviewed during these meetings. A detailed report on the outbreak can be helpful in planning for the next meeting. Following points will be discussed during the meeting: - Any changes that were made to initial response activities; - Recommended changes to improve epidemic responses in the future; - Dissemination of a report on the outbreak. When the disease surveillance system has been put in place, an independent external evaluation of the program will be carried out once a year or once in two years to determine whether: - The surveillance objectives are being met. Surveillance data are used for action. The improved surveillance has had an impact on health events at district and state levels. 26.2.1 Surveillance Reports High quality annual surveillance reports would be brought out at District, State and Central level within three months of completion of each year. These would be treated as key project deliverables. These reports would also be available on web site for wider dissemination. 113 26.3 Indicators for monitoring the program Following matrix gives specific indicators to monitor various activities under the Project: Annex 1: Project Design Summary INDIA: Integrated Disease Surveillance Project Hierarchy of Objectives Key Performance Indicators Data Collection Strategy Critical Assumptions Sector-related CAS Goal: To develop the capacity to manage public health programs effectively Sector/ country reports: National Family Health Survey NSSO surveys RCH survey UNICEF MICS SRS (from Goal to Bank Mission) Improved management of public health programs will contribute to poverty reduction in India Project reports: MOHFW reports at state and central level MOHFW reports at state and central level Periodic independent third-party surveys of a sample of 'responses' each 6 months. Third-party survey in Years 1, 3 and 5. (from Objective to Goal) Improved information does translate into better management of public health programs. Sector Indicators: (i) under-5 mortality rate; (ii) maternal mortality rate; (iii) nutritional status of under-5s; (iv) contraceptive prevalence rate. All in relation to the goals of the MDGs. Project Development Outcome / Impact Indicators: # and % of districts providing Objective: To improve the monthly surveillance reports on information available to time - by state and overall. # and the government health % of responses to disease-specific services and private health triggers on time - by state and care providers on a set of overall. # and % responses to high-priority diseases and disease-specific triggers assessed risk factors, with a view to to be adequate - by state and improving the on-theoverall. # and % of laboratories ground responses to such providing adequate quality of diseases and risk factors. information - by state and overall. # of reports derived from private providers. # of reports derived from private laboratories. # and % of districts in which private providers are contributing disease information. # and % of states in which surveillance information relating to various vertical disease control programs have been integrated under IDSP. # and % of project districts and states publishing annual surveillance reports within three months of the end of the fiscal year, publication by CSU of consolidated annual Surveillance report (print, electronic, including posting on the websites) within three months of the end of fiscal year 114 Hierarchy of Objectives Output from each Component: Component 1 - Establish and operate a Central-level Disease Surveillance Unit Key Performance Indicators Data Collection Strategy Critical Assumptions Output Indicators: Project reports: (from Outputs to Objective) CSU established and Central unit reports Central unit has required functioning with adequate staff and IT hardware. Bank reports Special surveys and assessments managerial and technical capacity IT software developed, operating and national network established. GOI willing to adopt new roles Central reports on national disease situation produced on time. Component 2. Integrate and strengthen disease surveillance at the state and district levels (a) State level - establish SSUs linked via IT network to CSU - support districts in gathering and entering information on time - support districts in timely response to diseasespecific triggers Center has the capacity to provide support and technical assistance to the states Number of SSUs established with adequate staff, IT Central unit reports State unit reports States willing to integrate disease surveillance activities hardware/software, linked to national network. Bank reports Special surveys and States and districts willing to assessments involve communities and the Number and % responses to disease-specific triggers private sector assessed to be adequate. Number of districts linked to the state and national disease surveillance network. (b) District level - Number of DSUs established State reports District and state units have PHCs/CHCs - ensure that district level actions take place on time, particularly training, QA, installation of network; - support reporting units in gathering and entering information on time with assigned staff and operating IT system. adequate skills, resources and authority to respond Private sector has adequate incentive to participate Number and % responses to disease-specific triggers assessed to be adequate. District reports Number of private health care 115 - respond to diseaseproviders contributing to specific triggers promptly surveillance reports. - promote participation by private providers and laboratories (c) Community level Number of villages/urban State reports Communities and private -provide information to wards reporting occurrence of District reports reporting units on disease health events. levels and unusual health Events sector have adequate incentives to participate Component 3 – Improve laboratory support - # of laboratories to be renovated/upgraded - # of laboratories to be equipped - implementation of quality assurance program Laboratory information is available in a timely manner and integrated into the surveillance system Laboratory information is of good quality # and % of district, state and national laboratories providing adequate quality of information in a timely manner. Central unit reports State unit reports Bank reports Special surveys and assessments # of reports derived from private laboratories. # of quality assurance surveys completed. Component 4 - Training for disease surveillance and action - design, implement, evaluate, and modify (as necessary) training programs to improve surveillance activities Number of staff trained in • general orientation • disease surveillance epidemiology and outbreak investigation • use of software • specific lab assays, quality control methods and reporting formats Quality of training - % of third-party assessments favorable. Central unit reports State unit reports Bank reports Special surveys and assessments 116 Hierarchy of Objectives Key Performance Indicators Data Collection Strategy Critical Assumptions Project Components / Sub-components: 1. Establish and operate a Central-level Disease Surveillance Unit Integrate and strengthen disease surveillance at the state and district levels stakehold 3. Improve laboratory Inputs: (budget for each component) USD 2.63 Million Project reports: USD 56.47 Million Supervision reports Special surveys Adequate and timely flow of funds from the states to the districts USD 26.57 Million Supervision reports Special surveys 4. Training for disease surveillance and action. USD 2.97 Million Supervision reports Special surveys Timely assignment of staff and consultants; equipment purchased, staff trained, Q A surveys implemented Timely procurement Evaluation and assessment of training Quarterly project reports (from Components to Outputs) Adequate and timely flow of funds from GOI to the states 26.4 Independent external evaluation of the surveillance and response Depending on the development status of surveillance in a state, program management, process and performance indicators will be identified. The IDSP will be then evaluated by an independent external agency using both qualitative and quantitative research methods. First external evaluation will be done at the end of first year and thereafter every two years. Recommendations of the external evaluation will be used to improve and modify the existing systems and also to follow up on the IDSP project. 26.5 Quality assurance of laboratory services in IDSP Practice of quality assurance should be an integral part of the program and mandatory for all the constituent laboratories of the Government. Quality assurance comprises of internal quality control and external quality assessment. It is planned to establish a network of external quality assessment providers, with the ICMR as the central coordinator. It is proposed to involve colleges in the country to be EQAS providers. A list of suggested centers is given below. For Peripherals laboratory – Provider Medical College laboratory For District laboratory – Provider State/ Medical College laboratory For States and Regional Laboratory – Central coordinator NIB and IEQAS For designated central, state and regional laboratory. Liaise with International QA laboratory coordinated by WHO 117 Central coordinators for Quality Control for Laboratories: National Institute of Biologicals In collaboration with Quality Assurance Division AIIMS New Delhi (North) Central Public Health Laboratory CMC Vellore (South) Colindale, London At the initiation of the program, a training workshop for conducting EQAS will be carried out for state providers. The state providers will then conduct workshops for participating laboratories to sensitise them and to learn the basic principles of quality assurance. Quality assurance in laboratory medicine is the means by which reliability, precision and accuracy of investigation used in support of optimal patient care can be achieved. Quality assurance comprises of internal quality control and external quality assessment. Very few laboratories are part of an external quality control program. There is need to develop this optimally in all levels for the laboratory network as part of the quality assurance program. Quality control of the peripheral laboratories will be the responsibility of the district public health laboratory. Confirming 5-10% of laboratory results of PHC laboratory should be made mandatory at the district laboratory. Private laboratories participating in the IDSP will enroll in the mandatory accreditation process for which established quality control procedures will be specified. Laboratory manuals for work on specific diseases will be made available to peripheral laboratories, both private and government, under IDSP program. Training, on job evaluation and retraining will be provided to the laboratory personnel as part of quality assurance. Quality control of the district laboratory will be done by the state laboratories. In addition to rules in the operational manual of procedure, detailed internal quality control procedures will be laid down. 5-10% of the results will be counter checked by the state laboratories as part of the quality control. Regular once a monthly feedback will be provided to the laboratories on the results of the quality control. All state and medical college laboratories will participate in the well established external quality control programme specified by MOHFW. Under the guidance of ICMR, selected reference laboratories and partner organizations will take up the responsibility for establishing external quality control mechanisms at the state level. 26.5.1 Role of National Centers for Quality Control To provide technical supervision and guidance to the Quality Assurance Providers in the country. To standardize methods, procedures and equipment and to supply these to QA Providers. 118 To prepare standard manuals of techniques for the constituent QA Providers. To serve as a center for the preparation and distribution of certain reagents and biological reagents for the constituent QA Providers. To serve as a training center for laboratory personnel and coordinate training programs for all QA Providers. To participate in international EQAS along with designated regional QA providers. To serve as a Repository of standard strains and reagents and regulate their supply to constituent QA Providers. 26.6 Accreditation Accreditation is a procedure by which an authoritative body gives formal recognition that a laboratory is competent to carry out specific tasks. Some countries have made it mandatory for laboratories to be inspected and accredited before they can start operating. In India Department of Science and Technology has established National Accreditation Board for Testing and Calibration Laboratories (NABL). NABL has started the process of accreditation of medical laboratories both in government as well as in private sector. Accreditation of constituent laboratories of IDSP will be the pre-requisite of starting the program. There are various national and international standards for accreditation, some designed for general purposes such as ISO9000 series and some specifically for laboratory accreditation, such as ISO 25, and the current ISO 15189. After program accreditation, the laboratories may be reassessed every 3 years. 26.7 Role of National Institute of Biologicals Initiate accreditation of laboratories taking part in communicable Disease Surveillance network. Follow a policy of reaccreditation Co-ordinate with CMC Vellore and AIIMS Delhi for information on quality assurance being followed by accredited laboratories. 119 Fig. Network of Quality Assurance Labs- Network of Diagnostic Health labs Govt. Army Rail ESI Private national EQAS Provider – State Lab/Med. Col District EQAS Provider NIB and IEQAS State Network of Reference Labs of Infectious Pathogen Reference Labs of Infectious pathogens Central Coordinator NICD International Collaboration IEQAS Coordinator NIB International Collaboration –WHO International Collaboration International Ref.Ctrs Coordinators NCD Coordinators ICMR 120 PART – VI ENVIRONMENT MANAGEMENT PLAN &TRIBAL DEVELOPMENT PLAN 121 27 ENVIRONMENT MANAGEMENT PLAN 27.1 Project Context India has high incidences and frequent outbreaks of diseases like tuberculosis, malaria, cholera, plague, encephalitis, typhoid, measles, hepatitis and dengue. The Ministry of Health and Family Welfare (MOHFW), Government of India, has initiated the Integrated Disease Surveillance Project, to strengthen the backbone of information network for effective public health delivery system in the country. The project will cover the whole country with the objective of improving diagnostic facilities in public health laboratories. 27.2 Scope of the Project The objective of the project is to support improved health outcomes by providing decision makers with specific timely information on selected priority health conditions and risk factors, so that preventative and control measures can be planned and implemented. The main components of the project are i) coordination and decentralization of disease surveillance activities; ii) strengthening of surveillance activities, especially at state and district levels; and iii) improved laboratory support to the surveillance system. The project will be implemented in phases across all the states and Union Territories. 27.3 Environmental Issues Disease Surveillance Laboratories carry out testing for infectious and contagious diseases, such as malaria, typhoid, cholera and hepatitis, tuberculosis and HIV/AIDS. These laboratories therefore generate waste which includes infected human tissues and blood samples, microbes, discarded chemicals, sharps, etc. Such waste, if not managed properly, carries the risk of infection for waste handlers and to the larger community and is also a potential environmental hazard, through pollution of land, water and ground water. Although the amounts of waste generated from such laboratories is small, its varied and hazardous composition requires comprehensive management of the waste lifecycle, from source to disposal, to prevent adverse impacts on the environment and public health. Adequate waste management in laboratories will not only improve overall environmental performance but also facilitate in providing a safe workplace for the laboratory personnel. In addition, laboratories have to comply with the environmental regulations of the Government of India, specifically the Bio-Medical Rules (prepared in 1998 and amended in 2000). As part of a baseline assessment of laboratories carried out by an international team in 3 states (Tamilnadu, Maharashtra and Uttar Pradesh), a review of waste management practices was carried out. Key findings included: 122 There is little awareness among the staff at State, district or peripheral laboratories of the existing GOI regulations and of good waste management practices. Standard safety precautions are not followed in laboratory operations At the district and peripheral levels, adequate waste management practices are not being implemented. However, the team also noted that Maharashtra has instituted basic processes of bio-medical waste management, under the existing Health System Development Project, and this can provide an initial framework in that state for dealing with laboratory waste. In addition, the Indian Council of Medical Research has developed and disseminated a document on bio-safety and hazardous waste (Standard Bio-safety Guidelines), which addresses safety for health workers and the importance of implementing the concepts of universal precautions and proper infectious waste disposal. 27.4 Actions to be taken under this project to address these issues. The main tool to be developed under the project, to address safety and waste management issues are Standard Operating Procedures for Laboratories. Under the project, Operations Manuals have already been prepared which focus on, among other technical topics, good laboratory practices, decontamination and Bio-safety issues. Given the related nature of the activities for ensuring good practices in laboratory operations, the SOPs on waste management will be integrated into the Operational Manuals for the laboratories. (Annex 1 provides a draft outline for an SOP. The USEPA “Environmental Management Guide for Small Laboratories” would also be a good reference document.) A Waste Management Program will also be formulated to define the processes required for dissemination and implementation of the SOPs at laboratory levels and for monitoring. The SOPs and WM Program will be finalized through a consultative process, involving the directors and operators of the national-owned and private laboratories to ensure a feasible and pragmatic program. 27.5 Project Implementation A Central Surveillance Unit (CSU), which is to be established at the MOHFW will be the responsible authority for project implementation at the national level. Surveillance Committees and Surveillance Units will be established at the state and district levels for implementation and monitoring of project activities. Waste management activities will be included as part of the laboratory support and training components of the project. At the laboratory level, the responsibility for the implementation of the SOPs will rest on the appropriate officer in-charge of the laboratory. 123 27.6 Key Activities under the project: Undertake a baseline assessment to review the health and safety and environmental practices and assess the quantum of waste generated. (This will build wherever possible on broader health care management and related activities, ongoing in a number of states.) Develop draft Standard Operating Procedures (SOPs) as guidelines for disease surveillance laboratories. Formulate a draft Waste Management (WM) Program for the dissemination of the SOPs, awareness and training at laboratory levels, including the roles and responsibilities of various parties, timetable and an estimate of the costs (investment and operating) and sources of funds for implementation. The initial program will be subject to refinement and adjustment in the initial stages of implementation, taking into account the overall health care waste management system in each state. Organize a national workshop to discuss the assessment findings and the draft SOPs and the WM Program. In addition to representatives from MOHFW and state authorities and municipal bodies, the group should include technical experts, representatives from WHO, NGOs and industry. Design and implement a training program for the implementation of the SOPs. The training will be divided into modules appropriate for the different responsibilities and skills of different groups, such as Medical Officers, laboratory personnel, technicians and cleaners. The training on WM practices will be incorporated within related training being proposed under the project. Support the implementation of SOPs in the laboratories in the various states, in phases as appropriate. The provision of basic equipment and infrastructure will be in accordance with the wider laboratory upgrading activities under the project and under a similar timetable. Establish an effective monitoring and reporting system. 27.7 Costs and resources The project will fund the CSU, including specialist technical support on issues such as waste management. The project will not provide for the on-going running costs of the SOPs, beyond support with the initial start up. It is therefore critical that implementation plans at laboratory levels are designed to be consistent with the level of resources that is expected to be available on a regular basis. More details on the estimated budget of the WM component will be provided after appraisal. 124 27.8 Monitoring The implementation of the waste management program will be subject to the same internal quality assurance systems and external audit provisions as apply to each laboratory under the project. 27.9 Schedule of Implementation Task Undertake baseline survey Draft Standard Operating Procedures for different types of facilities Formulate a draft Waste Management (WM) Program National workshop to discuss assessment findings, draft SOP and discuss proposed implementation Finalize SOP, dissemination and initial implementation Develop training module, schedule, manual and checklists. Implementation of training program Monitoring and evaluation Output Responsibility Time-schedule st Information on scale of WM issues at different types of facility. Draft documents State authorities 1 3 months of Year 1 (of each phase of implementation) CSU 1st 4 months of Year 1 Draft documents CSU 1st 4 months of Year 1 Consensus on scope and content of SOPs CSU by 1st 8 months of Year 1 Set of SOPs, applicable to different circumstances Set of standard training material for different audiences CSU, state authorities Before end of Year 1 CSU, with technical support Before end of Year 1 State authorities Starting from year 2, aligned with related project training; to be implemented in phases To be incorporated into overall project monitoring 125 28 STRATEGY FOR TRIBAL POPULATIONS The Integrated Disease Surveillance Project (IDSP) covering all states in India, seeks to assist the central and state governments to shift from a centrally driven, vertically organized disease surveillance system to one which is coordinated by the center and implemented by the states, districts and communities. Since the tribal population constitute the poorest and the most vulnerable of the social groups in the Project, a Tribal Development Plan is proposed as an integral part of IDSP. World Bank’s Operational Directive 4.20 related to Indigenous People is triggered in IDSP. There are 635 tribes in India located in five major tribal belts across the country. Based on 1991 Census data, tribals account for 8.08 percent of the country’s population (68 million out of 846 million). 7 Indian states account for more than 75 percent of the tribal population. The main concentration of tribal people is the central tribal belt in the middle part of the India and in the north-eastern States. However, they have their presence in all States and Union Territories except the State of Haryana, Punjab, Delhi and Chandigarh. The predominant tribal populated States of the country (tribal population more than 50% of the total population) are: Arunachal Pradesh, Meghalaya, Mizoram, Nagaland and Union Territories of Dadra & Nagar Haveli and Lakshadweep. There are 533 tribes (with many overlapping types in more than one State) as per notified Schedule under Article 342 of the Constitution of India in different States and Union Territories of the country with the largest number of 62 being in the State of Orissa (details in annex 1). The prominent tribal areas constitute about 15 percent of the total geographical area of the country and correspond largely to under developed areas of the country, wherein tribals inhabit isolated villages and hamlets. 28.1 Tribals in IDSP Widespread poverty, illiteracy and malnutrition, lack of personal hygiene, absence of drinking water, sanitary living conditions and health education, poor maternal and child health services, and ineffective coverage by national health and nutritional services, have been identified as conditions responsible for poor health status of the poor. Tribal settlements tend to be small and isolated and difficult to reach with facilities and services. Even when rural tribal people live in larger villages, they may be separated in hamlets. However, there are some tribal people who are relatively well integrated into the communities and access and utilize facilities as other subgroups do. Some tribal groups are nomadic and undertake seasonal migration in response to the need for livelihood or employment. In addition, economic development is forcing out-migration from traditionally tribal areas into cities, and often to the margins of such agglomerations. The ways in which the project would reach these different residential situations are outlined in the sections on Institutional mechanisms and Implementation and Local Participation. The project seeks to involve all stakeholders including tribals in disease surveillance to enable rapid identification of disease conditions and outbreaks to prevent large scale impacts and also is geared towards a quick response from the health system to this information. Involvement of tribals in the project would contribute to improved heath status among them. 126 For tribal populations this means that there is (i) strengthened link between the tribal communities and the health system leading to greater credibility of the health system, (ii) less reached and unreached areas where the tribals live are brought into the fold of disease surveillance; (iii) increased disease identification and reporting by tribal communities overcoming their socio-cultural and economic barriers; (iv) improved health awareness for disease prevention and treatment amongst the tribals; and (v) improved surveillance of the health of the tribals – project is expected to monitor a set of communicable and non-communicable diseases. 28.2 Integrated Disease Surveillance Project The project covers the entire country though the coverage will be phased with Tamil Nadu, Andhra Pradesh, Karnataka, Maharashtra, Mizoram, Orissa, Madhya Pradesh and Himachal Pradesh to be taken up in the first phase. Many of these states have substantial tribal populations with 2 states having tribals constituting more than 20 percent of the state population and the others have significant tribal populations. The major project objectives are: (i) (ii) the establishing of state-based system of surveillance for communicable and noncommunicable diseases and their risk factors so that timely and effective public health actions can be initiated in response to health challenges in the country at the state and national level, and to improve the efficiency of the existing surveillance activities of disease control programs and facilitate sharing of relevant information with the health administration, community and other stakeholders so as to detect disease trends over time and evaluate control strategies. The project also acknowledges that disease surveillance cannot be sustained unless the community supports data collection and the health system recognizes them as true partners. The project has four major components: Component 1. Coordinate and decentralize disease surveillance activities. This component will address the constraints of lack of coordination despite central control of surveillance activities and the need for changing the diseases included in the system. Effective coordination (as compared to control) of disease surveillance activities depends on establishing the appropriate processes and institutional arrangements at the central level. This will be done through the creation of a small disease surveillance unit to support the states' disease surveillance efforts. Component 2. Integrate and strengthen disease surveillance at the state and district levels, and involve communities and other stakeholders, including the private sector. This component will address the constraints imposed by lack of coordination at the sub-national levels, the limited use 127 of modern technology and data management techniques, the inability of the system to act on information and the need for inclusion of other stakeholders. Component 3. Improve laboratory support. This component will address the constraint imposed by inadequate laboratory support for surveillance through provision of equipment, minor renovation of laboratories and state level programs for quality assurance of laboratory data. Component 4. Training for disease surveillance and action. The changes envisaged under the first 3 components will require a large and coordinated training effort to reorient health staff to an integrated surveillance system and provide the new skills needed. The core set of communicable diseases, non-communicable disease (NCD) risk factors, and environmental factors included in the surveillance system are: malaria, acute diarrheal disease (cholera), typhoid, tuberculosis, measles, polio, plague, meningo-encephalitis, hemorrhagic fevers, HIV, road accidents, water quality, outdoor air quality and NCD risk factors (height, weight, physical activity, blood pressure, tobacco, nutrition and blindness). 28.2.1 Project Benefits Project beneficiaries would consist of all the tribal population in the project states and districts. The major benefits from the decentralization of disease surveillance mechanisms to the state, district and community levels would be increased interaction between the health system and the community, enhanced community knowledge of the community of disease and control measures, and improved monitoring and tracking of the disease burden of tribal groups. The propensity of sub-groups such as tribals and women to seek the necessary treatment is low for various reasons: their knowledge regarding symptoms is inadequate; myths, superstitions and stigma associated with many diseases are widely prevalent; there are widespread misconceptions about the cause and method of spread of diseases; there is low awareness of availability of treatment/drugs, and there is greater reliance on indigenous medical practices. The integration of the various disease surveillance programs would provide more complete and coherent health information, better monitoring of disease burden and improved health system response in the tribal areas too. In the tribal areas also, community-based information is a key input to the District Surveillance Unit (DSU) which will coordinate all the analysis, response and feedback of information. These should have a positive impact on the health of the tribals. 28.2.2 Legal Framework The Fifth and Sixth Schedules of the Indian Constitution provide protection to tribal populations on account of their disadvantages. The Fifth Schedule designates ‘Scheduled Areas’ in large parts of central India in which the interests of the ‘Scheduled Tribes’ are to be protected. The “scheduled” or “agency” areas have more than 50 percent tribal population. The Sixth Schedule applies to the administration of the states of Assam, Meghalaya, Tripura and Mizoram in the 128 North-East. This schedule provides for the creation of autonomous districts, and autonomous regions within districts as there are different Scheduled Tribes within the districts. The broad strategy that evolved from the constitutional mandates was the adoption of the Tribal Subplan since the Fifth Five Year Plan of the Government of India and the Integrated Tribal Development Approach, adopted and implemented with some modifications by subsequent government programs. Articles 46 and 47 of the Constitution of India provide a framework for tribal policy. Article 46, for example, provides the following directive: “The State shall promote with special care the educational and economic interests of the weaker sections of the people, and in particular, of the Scheduled Castes and Scheduled Tribes, and shall protect them from social injustice and all forms of exploitation”. Article 47 states that it is the duty of the State to raise the level of nutrition and the standard of living of the people, as well as to improve public health. An important objective of the National Health Policy, 2002 is the overriding importance to be given to ensuring a more equitable access to health services across the social and geographical expanse of the country and ensure that the access to, and benefits from, the public health system is ensured for tribals along with women, children and other socially disadvantaged sections of society. In response to these Constitutional provisions, the health sector has generally treated tribal areas as requiring higher health facility : population norms and are provided service accordingly. There are no laws or statutes that would prevent or constrain tribal access to health care. And on the basis of available data, it does not appear that either traditional or modern laws affecting tribal livelihood patterns (e.g.; land tenure, access to forest produce) mobility or other aspects of social or economic status would in any way cause tribal people to suffer more from diseases or deny them participation in, or the benefits of, this project. 28.2.3 Methodology for Preparation of Tribal Strategy The following methodology was followed for developing this Tribal development plan. 28.2.3.1 Consultations with Communities and Health Workers Two Districts each from the states of Maharashtra (Thane & Nagpur) and Tamil Nadu (Vellore & Dharmapuri), one each from Uttar Pradesh (Agra) and Chattisgarh (Bilaspur) were selected for carrying detailed consultations with communities and with health workers. While both men and women from urban and rural areas were consulted in Maharashtra, Tamil Nadu and Uttar Pradesh; in Chattisgarh state, the focus of the consultations were on women mainly in the tribal areas. A methodology based on rapid assessment procedures (RAP) was used because it permitted quick but systematic and valid data collection. Opinions, attitudes, constraints and suggestions regarding the surveillance activities of the respective areas from health workers as well as client were obtained through Focus Group Discussions (FGDs). Data was collected through focus 129 group discussions (FGDs) with grass root level male and female health workers (ANMs, AWWs, MPHWs and health supervisors) and tribal, rural and urban clients. A total of 15 FGDs were conducted in the four selected states of which 5 were carried out in Chhattisgarh state with women. To ward off most of these limitations in RAP, professional training for practitioners of RAP is of paramount importance. The study design had laid great emphasis on initial training of the investigators along with in built mechanism of quality assurance measures. 28.2.3.2 Quality Assurance Measures Several quality assurance measures were implemented/adopted right from the time of conceptualization of the study so as to improve the validity and reliability of the observations and the inferences which included: Guidance notes for Focus Group Discussions (FGDs) prepared by a multi-disciplinary team with diverse professional backgrounds, training and socio-demographic variability; who also analyzed the data; Guidance notes translated into local languages (Hindi/ Marathi/ Tamil) to help investigators; FGD notes piloted with mothers attending pediatric out-patient and in-patient services of All India Institute of Medical Sciences, New Delhi; All FGDs were conducted in the presence of at least two CCT members, one from the partner medical college and another from the team at AIIMS, CEU; During FGDs it was ensured that the discussion site was easily accessible and acceptable to all the respondents; respondents screened to ensure client category and socio-cultural group, homogeneity; Help was sought from experienced facilitators to guide (focus) the discussion in the right direction; Consent was obtained from the respondents and all the discussions were tape-recorded. The transcripts written during the discussion were supplemented from the audiotapes. The translation and interpretations were accordingly carried out with group consensus. The details of FGDs conducted in the four states and client characteristics are given in table 1. 130 Table 1 : Details of FGDs conducted and client characteristics S No Status Location District Urban/Rural/ Tribal) State 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Female Clients Female Clients Female Clients Female Clients Female Clients Male H W Female H W Male H W Female H W Male H W Female H W Male H W Female H W Male H W Female H W Gopalpur Goodbani Talapar Koni Vikas Nagar Lalapet Lalapet Dharmapuri Dharmapuri Fatehpur Sikri Bich puri Thane Thane Gumthala Kalmeshwar Bilaspur Bilaspur Bilaspur Bilaspur Bilaspur North Arcot North Arcot Dharmapuri Dharmapuri Agra Agra Thane Thane Nagpur Nagpur Tribal Tribal Rural Urban Urban Rural Rural Urban Urban Rural Rural Urban Urban Rural Rural Chattisgarh Chattisgarh Chattisgarh Chattisgarh Chattisgarh Tamil Nadu Tamil Nadu Tamil Nadu Tamil Nadu Uttar Pradesh Uttar Pradesh Maharashtra Maharashtra Maharashtra Maharashtra Major findings The major findings based on consultations with women clients in the tribal areas, as well as in the rural and urban areas are captured below. 1. Socio-cultural and economic barriers: Many of the prevalent beliefs about diseases and treatment prevented people from using the existing health facilities particularly in public sector. Both men and women expressed that since they were shy and embarrassed to talk about diseases related to sex and reproductive organs, particularly if they did not have a good rapport with the health workers. Thus, information related to HIV-AIDS, RTI, and STD was difficult to elicit. Similarly, tuberculosis and leprosy were considered diseases with social stigma. Occasionally mothers would not tell the illness of their children to health workers because they feared further wrath of evil spirits on their offspring. Limited cooperation from community and facilitators (Gram Panchayats, RMPs, NGOs etc) were also barriers in approaching health care systems. 2. Decision making process about health issues : Elders in the families influenced decisions regarding the place, type and timing of seeking health care especially in tribal areas. Tribal women perceived their education and financial status as important factors in taking independent decisions in matters of health for themselves and their children. Education and jobs for women was perceived by all as a necessary factor to bring about changes in their status and role in the society. Interestingly there were a few tribal and rural women, 131 especially those in nuclear families, who mentioned that husband and wife took all the decisions jointly as both were equal. 3. Seeking health care : Due to poverty, poor accessibility to health facilities and various sociocultural beliefs, home remedies are first resort. When symptoms do not ameliorate, help was sought from traditional healers. Thus, it was often quite late when they reached existing health facilities for their illnesses. However, for diseases that were perceived as serious in the community, patients were taken to hospital early. Use of herbal cures is more prevalent among tribal households. 4. Socio-Cultural factors in the care of sick: Illnesses are often viewed as a curse for which gods have to be placated by making offerings at the local temple. The offerings ranged from fruit and flowers to goat, chicken and liquor. Use of emulets, etc was also quite prevalent. 5. Gender barriers: Discussions with women in tribal areas consistently brought out the gender disparity to seek health care. When men fell sick, family got worried, and treatment was promptly sought. In contrast, attention was not given to the initial symptoms in women. If the symptoms did not subside on their own or with home remedies, then they were taken to health care providers. When it came to visit to hospital or doctor the males wanted their wives to accompany them but did not reciprocate this gesture. The women had to not only go alone for their illness but also had to take children, without their husbands accompanying them. Women face social, physical and economic barriers to seeking healthcare and are often seen to accord very low priority to their health needs. Further, the indifferent attitude of the doctors in the public health system, often force women to approach private providers – unregistered and registered. As a result, the surveillance data most often does not capture the conditions of women 6. Credibility of health system : Tribal women perceived that doctors in public sector health facilities did not provide good care to them because they were poor. Patients were either not given medicines or inadequate medicines were dispersed. The women also felt that whole treatment was ineffective because injections were given less often at government health facilities. Another reason for not visiting public health facilities was the lack of any health center near their homes. 7. Information sharing: While there was no voluntary sharing of information on symptoms and diseases, on enquiry there was sharing of information. Especially women expressed that no disease could be concealed for long and moreover concealment may lead to deterioration in the condition. However, tribal men did show resistance to information sharing. 8. Participation in Surveillance : Greater involvement of Panchayats, overall improvement in government health services in their area, greater awareness generation on disease surveillance through campaigns, were identified as important steps in enthusing communities for getting involved in reporting of various health conditions of public health significance. 132 9. Common health conditions/illnesses in the community: The Health conditions considered important by men and women in different settings are placed in table 2 below. Table 2: Health conditions perceived as important in Bilaspur District, Chattisgarh State Client Categories for Surveillance Men Women Children Tribal Rural Fever Jaundice Malaria Cough Fever Jaundice Malaria Cough Dysentery Fever Body ache Headache Stomach ache Malaria Cold Diarrhoea Dysentery Fever Body ache Headache Stomach ache Malaria Cold Diarrhoea Urban Flatulence Chest Pain Diminished vision Depression Diabetes Hypertension Goitre Diarrhoea Joint pains Increase in weight Allergies Diarrhoea Allergies Pneumonia Eczema Ear ache Cough In order to ensure active involvement of the tribals and that they benefit in a culturallycompatible manner, the project would ensure that: Focal social mobilization efforts in the tribal areas to elicit cooperation from the tribal community including the tribal leaders and tribal panchayat members; Training and involvement of local tribal volunteers in awareness generation campaigns for the tribal community; and for information collection in coordination with the health system staff Sensitization of health system staff working in the tribal areas and health facilities in the tribal sub-plan areas to develop a good working relationship with the tribal population; Design and use of culturally-compatible IEC material in the tribal areas; Monitoring and evaluation based on data disaggregated by tribal status and gender to allow tracking of efficacy of the IDSP among these groups. 28.3 Study of community-based disease surveillance systems In order to better understand the basic principles that would govern the setting up of communitybased surveillance systems under this project, an in depth study was undertaken of the strengths and weaknesses of existing efforts across the country. Of the systems studied were the North 133 Arcot District Health Information Network (NADHI), Kerala Government project on District disease surveillance program, BAIF surveillance, the Gadchiroli health program, Comprehensive Rural health system project, among others. The findings from this study, point towards the need for the following basic tenets as critical for involving communities including tribals in disease surveillance under the IDSP. Some of he key findings related to: Communities that are involved in the program are convinced and are confident that this effort is for their common good, People’s collectives like self help groups could be effective partners and their involvement could help sustain the process; local volunteers could be trained to assist in disease surveillance especially in difficult to reach areas where the presence of health staff is limited; Training of health staff for collection of high quality data, proper supervision; Integration of communicable and non-communicable diseases in the program; Selection of conditions that have significant association with public health action; Translation of information into public health action initiation and flexibility to, where necessary, modify prevalent approaches based on this information; Integration of private practitioners and Medical colleges in disease control efforts would strengthen the state’s effort; Higher level of technology – computerization with networking across Districts; Appropriate automated and predetermined responses built into the system based on trigger levels; Establishing systems for efficient sharing of information across vertical disease control programs and stakeholders belonging to departments other than health; Good laboratory support is to establish clinical rather than symptomatic evidence of disease occurrence. 28.4 Institutional Mechanisms The Government of India’s special provisions in tribal sub-plan areas include additional health facilities. In tribal areas, one Primary Health Centre caters to 20,000 persons instead of 30,000 and one sub-centre to 3000 instead of 5000 people. Tribal areas are also provided with more mobile clinics, allopathic, homeopathic, ayurvedic, unani and siddha dispensaries. In the project, the health workers at these facilities will be trained to be responsive to the tribals, provide them treatment and counseling activities, will help identify and train tribal volunteers and ensure information collection and response to the tribals with the tribal volunteers. The National and state-level Project Implementation Plans identify tribal populations as a target group with unique problems of physical and social access requiring culturally sensitive strategies. The project emphasizes two institutional initiatives which would address the needs of the tribal people: 1. Decentralization of planning and implementation to the state and district levels. This would increase the involvement of states and build capacity to manage and administer the IDSP over the long term. Guided by local needs, states will prepare and implement state-specific 134 annual plans with emphasis on the needs of special groups. This includes carrying out special mobilization campaigns in the tribal areas; and 2. Better relationship between the health system and the tribals through volunteers will lead to improved geographical coverage, particularly in remote and unreachable tribal areas. The project will coordinate with other health activities being carried out by the State Health Directorates for tribal areas. Representatives of Tribal Development Departments (TDD) would be included in state/district committees in those areas where tribal population is significant. TDD would assist in providing mapping and group-specific socio-cultural information on tribal groups and channels to expand outreach. They could also play a role in the participation of tribal groups. Population specific information will be used to develop culturally sensitive IEC materials for both public and providers. 28.5 Implementation and Local Participation The project seeks to address this by: Social mobilization strategies: Disease surveillance cannot be sustained unless the community stakeholders support the data collection and the health system recognizes them as true partners. Therefore, a well planned social mobilization strategy is to be put in place to obtain valid and reliable data with high sensitivity. The focus would also be on tribals and their collectives including tribal women self-help groups and mahila mandals; Preparation of simple case definitions for diseases: for use by tribals including women can use; Sensitization and training programs: planned under the project will be adequately “gendered” so as to sensitize field level staff to the special needs of tribal women; IEC plan : That specifically addresses the tribal perspective, will be developed by based on the state-specific context. Social mobilization campaigns under the IDSP are for: Creating awareness among the partners, notably the private practitioners, NGOs and the community about existing health programs, IDSP, the potential benefits, areas in which their participation will be solicited; Establishing an institutional mechanism to involve community and their leaders; Developing a system of providing regular feedback to the community about disease occurrence, the responses to surveillance and impact of disease control programs; Designing IEC to address all the issues that are likely to improve the sensitivity of the surveillance data, particularly the prevalent socio-cultural beliefs and gender disparities; 135 Increasing the reach of the campaign, all channels of communication are to be used; these will include electronic media, press, hoardings, hand bills, posters, and interpersonal communication through health providers at all levels; Creating targeted campaigns in terms of content and messages for health workers and private practitioners; and for the community, panchayat members, local influential persons and NGOs. At different levels of the project; the following will be undertaken: Central level: Organizing a media campaign for creating mass awareness about the usefulness of the surveillance, about core disease surveillance, dispelling common socio-cultural beliefs and gender disparity Sensitization and mobilization meetings for central and state level functionaries of IMA and other professional bodies to solicit their support for the program Some IEC material for health functionaries and selected sentinel private practitioners, highlighting technical issues State Level Organizing a media campaign for creating mass awareness about usefulness of the surveillance, about core and state specific disease surveillance, dispelling common socio-cultural beliefs and gender disparity Sensitization and mobilization meetings for state and district level functionaries of IMA and other professional bodies, medical colleges, NGOs involved in health, to solicit their support for the program IEC material for health functionaries and selected sentinel private practitioners highlighting technical issues IEC material and messages to be prepared within the local context and in the locally comprehensible language Bring out periodic reports on surveillance data and the consequent responses by the health department as feedback to the community and local leadership District Level and Periphery Organize sensitization and mobilization meetings at district head quarters for local IMA executive members, prominent practitioners, NGOs in health, elected representatives of the local as well as state bodies, district panchayat board members, teachers IEC material and messages to be prepared within the local context and in the locally comprehensible language; put up hoardings, posters, distribute hand bills to create wide spread awareness. The IEC material has to be displayed in schools, all sentinel sites, prominent locations in the village and busy street crossings in urban areas, and in all places where mass human gatherings occur e.g. festivals, melas, exhibitions 136 Village and Block level organize meetings between medical officers of the area, health workers and village health committees once in three months, with the purpose of revitalizing this institution; enhance community participation in all health related matters and identifying the community as partners in the planning and decision making process. While some of the activities like strategies for mobilization and training are common, the case definitions across states for common disease identified for surveillance would be similar but each state will develop sate-specific definitions for the specific conditions that they will be tracking. Similarly successful approaches of IEC already being implanted in the states will be used for furthering disease surveillance. 28.6 Cost estimate and financing plan No separate costing or financing plan has been prepared for tribal populations, because the project addresses all groups including marginalized groups such as tribals and women. 28.7 Monitoring and Evaluation Sampling design of evaluation studies would include tribal districts/blocks on a representative basis. The project will monitor increased knowledge of communities and their involvement in surveillance activities. Community monitoring, a key project issue, would strengthen inputs to M&E by helping to capture information that would have gone unrecorded due to socio-cultural barriers and gender discrimination faced by communities, especially vulnerable groups. These data would demonstrate the extent to which tribal people have participated in and benefited from the project. 137 Table : Major Tribes of India STATES Andhra Pradesh Assam Bihar & Jharkhand Gujarat Himachal Pradesh Karnataka Kerala Madhya Pradesh and Chhattisgarh Maharashtra Meghalaya Orissa Rajasthan Tamilnadu Tripura West Bengal Mizoram Arunachal Pradesh Goa Daman & Diu Andaman & Nicobar Islands Dadra & Nagar Haveli Uttar Pradesh & Uttaranchal Nagaland Sikkim Jammu & Kashmir TRIBES Bhil,Chenchu, Gond, Kondas, Lambadis, Sugalis etc. Boro, Kachari, Mikir (Karbi), Lalung, Rabha, Dimasa, Hmar, Hajong etc. Asur, Banjara, Birhor, Korwa, Munda, Oraon, Santhal etc. Bhil, Dhodia, Gond, Siddi, Bordia, etc. Gaddi, Gujjar, Lahuala, Swangla, etc. Bhil, Chenchu, Goud, Kuruba, Kammara, Kolis, Koya,Mayaka, Toda, etc. Adiyam, Kammrar, Kondkappus, Malais, Palliyar,etc Bhil, Birhor, Damar, Gond, Kharia, Majhi, Munda, Oraon, Parahi, etc. Bhil, Bhunjia, Chodhara, Dhodia, Gond, Kharia, Nayaka, Oraon, Pardhi, Rathwa etc. Garo, Khasi, Jayantia, etc. Birhor, Gond, Juang, khond, korua, Mundari, Oraon, Santhal, Tharua, etc. Bhil, Damor, Garasta, Meena, Sahariya etc. Irular, Kammara, Kondakapus, Kota, Mahamalasar, Palleyan,Toda etc. Chakma, Garo, Khasi, Kuki, Lusai, Liang, Santhal etc. Asur, Birhor, Korwa, Lepcha, Munda, Santhal, etc. Lusai, Kuki, Garo, Khasi, Jayantia, Mikir etc. Dafla, Khampti, Singpho etc. Dhodi, Siddi (Nayaka) Dhodi, Mikkada, Varti, etc. Jarawa, Nicobarese, Onges, Sentinelese, Shompens, Great Andamanese As in Daman & Diu Bhoti, Buxa, Jaunsari, Tharu, Raji Naga, Kuki, Mikir, Garo, etc. Bhutia, Lepcha Chdddangpa, Garra, Gujjar, Gaddi, etc. 138 PART – VII STRATEGIES FOR INVOLVEMENT OF PRIVATE SECTOR IN DISEASE SURVEILLANCE 139 29 STRATEGIES FOR INVOLVEMENT OF PRIVATE SECTOR IN DISEASE SURVEILLANCE 29.1 Initiate Partnership With Private Health Providers For Disease Surveillance There is need to develop MOU with Indian medical Association, Indian Pediatric Association and other professional bodies at the Central and state level for partnership under Integrated Disease Surveillance Project. Discussions with the IMA and IAP at the state level felt that Memorandum of Understanding with the organizations are necessary both at central and state levels for effective participation at the district level. Central Surveillance Unit would develop a MOU with the National Office bears of IMA and IAP as the initial step. An official letter of invitation for partnership is needed from the MOHFW to initiate this process both at the central and state level. The state branch of IMA and IAP will enter into separate MOUs on participation in IDSP. This MOU should specify the number of units of SSPs that is expected from each of the state and districts of the country and specify that the final selection may be made in consultations based on criteria of selection. 29.2 Selection of SSPs Type of Health Facility that would be suitable to function as sentinel surveillance Unit include a). Hospitals, b). Nursing homes, c). Clinics Wherever available, the choice of the institutions can be prioritized based on the number of patients of specific interest to surveillance seen. Volume of patients is usually higher in hospitals followed by nursing homes and then clinics. Popular Indian system of medicine private health providers and Registered Medical Practitioners may also be recruited in specific situations. There is need to include both inpatients and outpatients in the surveillance since severe presentations and mortality will be reflected in the inpatients and milder and earlier disease will be reflected in the outpatient surveillance data. Though health clinics overall see the bulk of the outpatient load. However per unit recruited it is less efficient than larger nursing homes and hospitals regarding outpatient and inpatient services. Since IDSP is focusing on sentinel level surveillance from the private sector, efficiency (number of cases of general practice, Medical and pediatrics) would be the primary criteria to choose a reporting center. 29.3 Method of Selecting the Sentinel Surveillance Unit DSU should verify list of health facilities and health providers in consultation with district chapter of IMA & IAP and Directorate of Public Health. If such lists are not available, the state could initiate a rapid assessment to enlist all health facilities in the district. The final selection of 140 the participating units should be in consultation with the district chapter of IMA or IAP so that the associations take responsibility and ownership of the reporting unit. The list should include names, contact numbers and other information on type of cases seen by them. District Surveillance Officer will choose additional centers as required based on specific situational analysis in the district. This would include, geographical representation, tribal areas, urban slums etc. There may be tribal and rural areas where sufficient number of health clinics manned by qualified health care providers may not be available. In these areas there are informal private health providers (RMPs) and qualified providers under Indian systems of medicine who can be chosen to function as sentinel sites. 29.4 Number of Sentinel Surveillance Units Recruiting the SSUs can be initiated in a phased manner. Number can be increased over time during the course of the Project. Though ideally all the selected conditions required to be under surveillance need to be covered by all the SSPs, this is unlikely to happen since a pediatrician is not likely to report on leprosy and general medical practitioners are unlikely to be reporting on Acute Diarrheal Disease which is primarily a child hood problem. Where hospitals are fewer (rural areas in some districts) it is likely that more SSPs will need to be identified, while in other districts where sufficient hospitals and nursing homes are available, SSPs may be limited. In large metros, there is no dearth of hospitals. There will be at least 20 sentinel hospitals selected from each city / municipal limits as SSPs. 29.5 Data Collection and Transmission Following will be highlights of data collection from the Private Sector: a) Regular Weekly report: All selected Sentinel sites should provide weekly reports on the conditions under surveillance agreed upon with the District Surveillance Office b) If no cases are seen Nil report is mandatory c) Number of conditions under surveillance will be decided in consultation with DSU. Sentinel surveillance unit can be given freedom to choose and limit the conditions under surveillance by each unit. Hospitals would be encouraged to report all diseases of interest but nursing homes and health clinics may choose from the list of diseases under surveillance. d) A choice of methods for transmission of data to the district level will be given to SSPs.. Flexibility will be provided in the method of reporting by the SPPs. Each PHC may choose an optimal method that is suitable in the situation. The method of sending the report will be finalized appropriately for each reporting unit so that if there is delay in reporting this can be quickly addressed and will be noted at the appropriate level. Any of the following methods may be used: 141 Telephone followed by mailing of IDSP format by hard copy Fax to DSO Electronic mailing direct to DSO Courier a. Office of the DSO / CHC b. Direct contact with Health Worker if necessary c. Private Courier can be contracted Telephonic reports will be encouraged during epidemic situations so as to avoid delay. MO Block PHC / computer entry person / District Surveillance Officer will be able to receive information from the periphery. Routine reporting will be facilitated by the health worker visiting the SPPs in the rural areas on specific days assigned for reporting. In urban areas, telephones can be used or the health workers can collect reports from SPPs as done in the polio program. e) Simplified formats for reporting will be used to identify cases on a weekly bases as given below: Reporting Format for Sentinel Sites District Code Number: Sr. No. Suspected Diseases/ Syndromes (New cases) 1 Ac ute Wa ter y D ia rr hoea M /Cho lera F Tot 2 Fever > 7 d a ys / Typ ho id M F Tot 3 AFP < in le ss t ha n 15 years M of a ge / Po lio F Tot 4 Fever w it h ra s h / Mea s les M F Tot 5 Fever /Ma lar ia M F Tot 6 Caugh > 3 we eks / M Tuberc ulos is F Tot 7 U nus ua l s yndro me s ca us ing M deat h or hosp ita l ad miss io n F T 8 Fever w it h Bleed ing / M De ngue F T 9 Fever w it h A lte red M Consc io us ness o r F Convuls io ns / J E T 10 O ther s Spec ify M F T Unique identifier for Reporting unit: Patients treated OPD IPD Total <5 >5 <5 >5 <5 >5 Death <5 >5 142 If no cases are seen ‘0’ will be marked against the corresponding disease and the results submitted to the DSO or MO PHC/CHC 29.6 Integrating Private Sector under IDSP The SSPs will act primarily as an afferent arm of surveillance in data collection Health inspectors from PHC, CHC, District Hospitals will function as the link person between SSPs and Public sector units responsible for surveillance action. In Tamilnadu, the Health inspector is currently the key integrating person. This model could be expanded under IDSP. Health Inspectors or equivalent officials are posted currently in all PHCs and many urban hospitals. With training these personnel could be the integration factor between private and public health system at the rural and urban levels of the state. Each of the sentinel private sector unit participating in the surveillance is under the supervision of one health inspector. On a weekly (in outbreaks daily) basis, he/she would visit sentinel sites in different regions and collect information on the cases of interest. The routine allows once a week visit to each of the sentinel sites. The data will be collated by the Health Inspectors and passed on to the PHC doctor for forwarding to DSU. 29.7 Increasing Sensitivity of Reporting Units There has been some pilot projects which has shown partial success in integrating private health providers in sentinel surveillance. The lesions from NADHI and Kerala district surveillance model could be used to increase the sensitivity of reporting in IDSP. Pre-paid post cards with the names of the diseases/syndromes of interest are distributed to all health providers who are encouraged to mail the cards to the DSU as and when there is a change in trends of disease or some unusual syndromes in the locality. Since this is similar to the rumor registry but with better organization the DSU or PHC/CHC medical officer will undertake epidemic investigations as warranted to confirm changing trends or emerging outbreaks. There is no insistence on zero reporting and a wide spectrum of private health providers can effectively participate in this program. To be effective active distribution of pre-paid post cards will need to be carried out. Feed back need to be provided to participating health providers by the DSU. The same system can also encourage a wider group of RMPs and Indian system of medicine doctors also to participate reporting unusual trends in disease through prepaid post cards. 29.8 Maintaining quality of Reporting To ensure that quality of information is maintained, following steps will be taken: Ensure Availability of Operations Manual Training of SSPs on IDSP should be provided. Each SSPs should state the diseases of interest which will be under surveillance and mode of transmission of this data to the next level 143 Health Inspectors / Leprosy inspectors may need to visit the units at regular intervals to facilitate regular reporting Feed back from DSU is very important for maintaining quality of reporting All the private health providers who participate in the program as SPPs should have the hard copies of operations manuals provided by the district surveillance team. This along with training should ensure quality of reporting. Private health providers are busy during regular working time and short duration half day training programs particularly during weekends are suitable for improving their knowledge, attitudes and skills under IDSP. These programs need to be separately arranged from the health workers and unqualified private health providers. The respective associations may be requested to organize this activity in which the district surveillance officer and the district training team can participate. The training should include An overview of the IDSP and its objective Data collection Specimen collection Reporting formats and frequency Trigger levels and type of public health measures Feed back Feed back from the District surveillance officer should specify the accuracy of reporting, the timeliness and regularity to individual SSPs at monthly intervals. 29.9 Sustainability of Partnership To sustain partnership with private sector, following initiatives will be made: Incentives Maintain confidentiality in sensitive information. Consider SSPs as equal partner in the program Feedback There seems to be general agreement that financial incentives for SSPs are not possible for their participation. Experience with NADHI surveillance system in Vellore and Kerala Model of District based surveillance have shown that the following incentives are sufficient for private sector participation. These include: Actual cost of participation may be re-imbursed without delay as done in polio program. This may be postal or telephone charges. Inclusion of name in the network directory. Representation in the District surveillance committee Certificate of recognition and participation for participation in National IDSP. Access to IDSP computer web reports. Quarterly bulletins on health status of the region from District Surveillance Officer. 144 Feedback on surveillance from the district surveillance officer on a regular basis. Membership in village health committee meetings on rotatory basis. 29.10 Continuing Medical Education Session: One of the important felt needs of the private practitioners is method to improve their patient care by updating the current knowledge about management options. The IMA meeting and IAP meeting this factor emerged as an important incentive to be a part of the sentinel surveillance unit. The association may be provided support money to conduct once a year CME session at the state capital to their members participating in IDSP. These CMEs should be allowed to be organized and conducted by the organizations themselves and be seen as a clear incentive for their participation in the program. The choice of the subjects for CME and also the choice of the resource persons invited for these CMEs should be primarily decided by the respective associations. Participation of the medical colleges and other experts could be facilitated by the state IDSP committee. The forum could also be used to give feed back on the role of SSPs in IDSP and provide further reinforcement on the methodologies in surveillance. 29.11 Other Determinants of Sustainability: In the discussions with IMA members regarding their experience with participating in government program, one of the most important factors that determine success was listed as respect for the private sector. There is lot of good being performed by both private and public health sector for the health of the country and there are a number of success stories where true partnership has shown a new way of success. There is need to highlight these success stories in the training programs for IDSP. There should be mutual respect and consideration as equal partners rather than as junior officers of the government service since independence is the most important reason why private providers remain as private providers. The participating units and doctors has to feel that they are benefiting the society through the activity and at the same time gain regarding pattern of diseases in the community. Both these factors can be achieved through a proper feed back mechanism, which has to be built in as part of private sector partnership. Printed quarterly reports will be sent to all participating SPPs from the district surveillance unit. This bulletin will list all the SPPs who are contributing to the program in the district and the number of cases reported by them I-n each quarter. The experience of NADHI has shown the importance of a motivating person or group which is needed for successful sustainability of the program. There is need for hand holding and constant support and encouragement from this person or group for the private practitioners. In IDSP the district surveillance office necessarily have to take on this responsibility of bringing together and integrating the private and public health systems in the region. 145 29.12 Evaluation The district and state surveillance officers will make internal assessment of private sector participation every year which include Process Indicators: Number of SSPs identified and participating in the program Percentage of SSPs completed training for IDSP Percentage of SSPs reporting with more than 80% regularity Timeliness of reporting by SSPs Total number of interactions of Health inspectors with SSPs Number of feedback reports received by the SSPs from DSU Number of CME programs conducted with support from IDSP External Evaluation will be conducted on the level of success of private sector participation in IDSP. The strategy of private sector participation will be evaluated at the end of 2 years to assess the status of functioning. The indicators for evaluation will include the following in addition to the process indicators mentioned above Performance Indicators: Number of outbreak investigations carried out in response to information from SSPs Number of pre-paid cards received by DSO from private sector health providers Number of disease outbreaks detected through private sector Feedback from partners 146 PART – VIII PROCUREMENT OF GOODS & SERVICES 147 30 PROCUREMENT OF GOODS AND SERVICES Integrated Disease Surveillance Project aims at developing a surveillance system capable of monitoring occurrence of selected communicable and non-communicable diseases in an integrated manner with the objective of forecasting situations where risk of outbreak of specific diseases could be predicted. This would help in curbing outbreaks at early stages. The project would also help in assessing trends of common communicable and non-communicable diseases over time, which would help in effective planning and resource allocation in the health sector. Diagnosis of target diseases, assessment of emerging situation through use of information technology and rapid response to prevent and control target diseases are the key activities of the project. The project would be implemented throughout the country in all 592 districts. For effective implementation of the project, the project would be introduced in 3 phases in the first 3 years of the project as given below: Phase I (2004-05): Tamilnadu, Maharashtra, Karnataka, Andhra Pradesh, Uttranchal, Himachal Pradesh, Madhya Pradesh, Kerala and Mizoram covering 206 districts; Phase II (2005-06): Gujarat, Haryana, Rajasthan, Orissa, Chattisgarh, West Bengal, Delhi, Goa, Chandigarh, Manipur, Meghalaya, Tripura and Pondicherry covering 176 districts; Phase III (2006-07): Remaining States/UTs covering remaining 210 districts. Phasing has been decided on the basis of preparedness of the States to launch the project. Phasing would also help in proper monitoring and supervision of the Project. Procurement of works, goods and services would be done at Central, State and District level based on method of procurement, availability of goods and services, capacity of the States/Districts, logistics and sustainability. Level and method of procurement is described in each section of this chapter. At the central level and in some cases at the State level (depending upon the method of procurement of quantity of goods), services of Procurement Agents would be sought. Component-wise details are given below: 30.1 Civil Works: Renovation and Repair [Annexure 1] The project does not envisage any new construction activity. Civil works proposed under the project are basically renovation/repair of existing structure and in some cases there may be need for extension of facilities. These works would be required at all levels: Peripheral (Laboratory and Peripheral Surveillance Unit at CHC), District (District Public Health Laboratory/District Surveillance Unit), State (State Public Health Laboratory/State Surveillance Unit) & Central Surveillance Unit. Estimated Number of Works, Unit Costs and Total Costs are given below: 148 No. of Works I. Peripheral 3356 II. District 1184 III. State 62 IV. Central 2 Total 4604 Level Unit Costs (Rs. in million) 0.02 0.14 0.14 1.00 Total Costs (Rs. in million) 67.12 165.76 8.68 2.00 243.56 Method DC NS NS NS Civil works would be undertaken through following methods: Level I: Direct Contracting (DC), as the works are small and widely distributed Level II & III: National Shopping (NS) - District wise Level IV: National Shopping (NS) by Central PWD Civil works will be completed in the first three years of the project. State-wise and year-wise distribution of civil works is given at Annex 1. Year-wise number of packages and their values are indicated below: (Rs. in million) Works at: Peripheral Laboratories District Laboratories & Surveillance Units State Laboratories & Surveillance Units Central Laboratories & Surveillance Unit Grand Total Estimated Cost Year 1 Year 2 Total Cost Year 3 No. of Packages Cost No. of Packages Cost No. of Packages Cost 0.02 1,634 * 32,68 989 * 19.78 733 * 14.66 67.12 0.14 412 # 57.68 352 # 49.28 420 # 58.80 165.75 3.64 18 # 2.52 8.68 - - - 0.14 18 # 2.52 26 # 1.00 2# 2.00 - - 2,066 94.88 1,367 72.70 * Direct Contracting ; # National Shopping 1.171 75.98 149 243.56 30.2 Goods & Equipment Procurement, installation and commissioning of Laboratory & Information–Technology equipments are a major component of the project. These are grouped in six categories: (a) Lab Equipments: [Annexure 2, 2/I, 2/II] Laboratory equipments are required at 4 levels-Peripheral, District, State and National level Laboratories. Requirements would be worked out by assessing existing availability of equipment. Total estimated numbers of labs at various levels along with estimated costs are given in Annexure 2. Total estimated cost of this component is Rs. 641.94 million. Method of procurement and number of packages along with their values are summarized below: (Rs. in million) Method of Procurement ICB NCB NS Total Value Year I Year II Year III No. Of Packages Value Range 4 93.20 30.00-60.00 4 104.50 30.00-60.00 No. Of Packages Value Range 3 16.30 10.00 – 14.00 216 137.01 0.10 - 0.80 246.51 4 85.50 30.0060.00 3 15.95 10.00 – 14.00 189 86.61 0.10 - 0.80 188.06 No. of Packages Value Range 3 15.45 10.00 – 14.00 219 87.42 0.10 - 0.80 207.37 Current availability of Lab equipments at each facility would be assessed as early as possible to determine requirement of each item enlisted for Laboratories at each level. The equipments would be grouped as minor and major and procured through following methods: Minor instruments & equipments (each item costing less than Rs. 100,000): National Shopping (NS) by Districts/States; and Major equipments (each item costing Rs. 100,000 or more): National/International Competitive Bidding. (NCB/ICB). Lab equipments would be procured in the first 3 years of the project. Lab equipments by NCB or ICB would be procured centrally. Normally States/Districts would procure the 150 equipment under National Shopping. States having capacity and successful experience of having procured goods under World Bank projects can also undertake procurement under NCB. However, at the request of the States/UTs, equipment could also be procured at the Central Level. Total number required for each of the above items at all levels for Phase I states is being worked out in consultation with the States. Similar assessment will be worked out for Phase II and III. Provisional lists of items along with numbers required at each level is given at Annexure 2/I. Year wise number of packages according to procurement procedure is given at Annexure 2/II. (b) Computer Hardware and Operating System[Annexure 3, 3/I] Development of IT network connecting peripheral, district, state and central surveillance units is a major component of the project. The goods included in this component are computers of different configurations, printers, and modem, UPSs along with accessories required for networking. These would be procured as packages through International Competitive Bidding. Total estimated cost for this component is Rs. 451.85 million. State-wise and facility wise estimates are given in Annexure 3. Computer Hardware alongwith Operating System on Clients is proposed to be provided at various levels as given at Annexure 3/I. As states would be covered in 3 phases, the bidding process would be undertaken Phase wise in each of the first three years as per details given in Annexure 3.These items will be procured as 3 ICB packages during the first 3 years of the project, value of packages being Rs. 156.87 million, Rs. 139.14 million and Rs. 155.84 million. (c) Office Equipments: [Annexure 4, 4/I] Office equipments include photocopiers, overhead projectors; fax machines, telephones, LCD projectors, air conditioners etc. These items are usually not manufactured by the same firm and therefore would be procured as individual items. Districts/States would therefore, procure these items through National Shopping and/or NCB at the central level as indicated in Annexure IV. Items like Telephones and Air Conditioners, which require frequent maintenance services, have been included under National Shopping. State wise and unit wise estimates are given in Annexure 4. Total estimated cost for this component is Rs. 102.59 million. List of office equipment at various levels is given at Annexure 4/I. These items will be procured as NCB and NS packages in first 3 years of the Project as per details given below: 151 (Rs. in million) Method of Procurement NCB National Survey Total Value No. of Packages Value Range No. of Packages Value Range Year I Year II Year III 5 18.28 2.00 – 11.00 434 22.99 0.05 – 0.10 41.27 4 15.18 2.00 – 11.00 378 15.56 0.05 - 0.10 30.74 4 16.68 2.00 - 11.00 438 13.90 0.05 - 0.10 30.58 (d) Operating System for Server, RDBMS, Website tools and GIS software: [Annexure 5, 5/I] Operating system is required for carrying out various functions (data entry, data analysis, transmission of information and reporting) of networking the computers. These are off the shelf available items and will be procured centrally under ICB procedures. Total estimated cost of this component is US $4.42 million equivalent. There will be three ICB packages, one for each phase of the project at an estimated cost of US $1.55 million for phase 1 (year 1), US $1.34 million for phase 2 (year 2), and US $1.53 million equivalent for phase 3 (year 3) of the project. To carry out various functions related to data entry, transmission of information, data analysis and reporting, OS for Server, RDBMS, Website tools and GIS software would be procured and installed in Surveillance Units at all levels. These are readily available items and would be procured off the shelf as packages through ICB at the central level to ensure uniformity throughout the country. Total estimated cost of OS for Server, RDBMS, Website tools and GIS software is Rs. 200.76 million. State-wise & year-wise requirements of software at various levels are given at Annexure 5. OS for Server, RDBMS, Website tools and GIS software to be procured at various levels are given at Annexure 5/I. These software items will be procured as 1 ICB package each in the first, second and third year of the project and value of the packages is Rs. 70.22 million, Rs. 61.00 million and Rs. 69.54 million respectively. (e) Furniture & Fixtures [Annexure 6, 6/I] Laboratories and surveillance units at various levels would require furniture and fixtures i.e. tables, chairs, laboratory platforms, washbasins, etc. These would be procured through National Shopping (3 quotations) procedure as requirements are to be tailored according to local conditions existing at the laboratory/surveillance unit level. Total estimated cost of furniture is Rs. 142.48 million. State wise and unit wise estimates are given in Annexure 6. 152 Items required at laboratory and surveillance unit levels are given at Annexure 6/I. These items will be procured by National Shopping at District, State and Central level, the number of packages being 217, 189 and 219 packages in the first, second, third year of the project, respectively. District will procure for Peripheral units also and the cost of each package will not exceed Rs. 0.40 million. (f) Laboratories reagents, chemicals & other consumables including glassware (Material & Supplies) [Annexure 7, 7/I] Laboratory consumable goods and supplies would be required continuously for undertaking various diagnostic tests. A maximum of 15 items by peripheral labs, 21 items by district/state laboratories will be procured. Details of the items required by the peripheral, district and state laboratories are given in Annexure 7/I. All these items would be procured through National Shopping at the District and/or State level except some items like HIV kits (incremental over and above provided by NACO), Rapid Test kits for Typhoid etc. Since these items may not be available in all the districts, these would be procured through National Competitive Bidding at the Central level. Total estimated cost of these goods at various levels is Rs. 310.50 million with details in Annexure 7. Each items of Rapid Diagnostic Kit for Typhoid, Rapid test kit for faecal contamination and HIV diagnostic kit ELISA will be procured separately as 3 NCB packages in each of the first 3 years of the project. Number of National Shopping Packages will be as under: (Rs. in million) Method of Procurement NCB National Shopping Total Value No. of Packages Value Range No. of Packages Value Range Year I Year II Year III Year IV Year V 3 3 3 3 3 3.87 1.00 – 2.00 215 7.53 2.00 – 4.00 404 10.53 3.00-5.00 10.53 3.00-5.00 10.53 3.00-5.00 623 623 623 26.00 0.15 – 0.30 29.87 45.40 0.15 – 0.30 52.93 65.37 0.15 – 0.30 75.90 65.37 0.15 – 0.30 75.90 65.37 0.15 – 0.30 75.90 District will procure for Peripheral units also and the cost of each package will not exceed Rs. 0.30 million. 153 30.3 Services For hiring of consultancy services under Quality and Cost Based Selection (QCBS) method, technical and financial weightage will be in the ratio of 60:40 for hiring of services of a procurement agent, 90:10 for development of application software for surveillance and 70:30 for other consultancy services. The leasing for Wide Area Networking (WAN) would be through the least cost selection method subject to the qualification parameters agreed to by GOI and the Bank. a) Procurement Consultants For procurement of goods, equipment, IT hardware and software and selected lab material etc. at the central level, a procurement agency would be identified through Quality & Cost Based Selection (QCBS) (weightage: technical 60% & financial 40%) method of hiring of consultancy services. For calling expression of interest, criteria would also include experience in procurement of goods/equipment under World Bank project. Estimated costs of procurement at central level during the project period, would be approx. Rs. 1250 million. Estimated fees of procurement consultant would be approximately Rs. 25 million. b) Individual Consultants & Contractual Services [Annexure 8, 8/I] For various specialized services, consultants/contractual personnel would be needed for the entire period of project. These would be engaged following World Bank procedure of Short Term Consultants i.e. by preparing & getting T.O.R. approved, advertisement in leading newspapers and selection of the most suitable candidates. The job description, minimum qualification and experience, terms of employment and selection procedure shall be cleared by the World Bank. Respective units at District, State and Central level would hire these individuals. Number of Surveillance Units where consultants/contractual personnel would be required and estimated costs are given below: Level No. of Units II. District III. State IV. Central Total 592 31 1 624 Unit Costs/Year (Rs. in million) 0.20 0.60 2.40 Costs for 3-5 Years (Rs. in million) 472.80 74.40 14.00 561.20 Numbers of consultants/contractual personnel at various levels along with annual proposed consultancy fees are given in Annexure 8. State-wise & year-wise requirement of personnel at various levels and costs involved are given in Annexure 8/I. Total number of personnel to be hired year wise and their costs are given below: 154 Year I Year II Year III Year IV Year V No. of Personnel 902 1697 2600 2600 2600 Costs (Rs in million) 51.00 92.00 139.40 139.40 139.40 c) Consultancy for Development of Application Software for Surveillance : A specific type of application software would be required for effective surveillance of various diseases. This would require identification of application software development agency to carry out the job of developing, testing, operating, training and maintenance of Application Software. This application software will ultimately be the property of the client (Government of India). Development of application software and its application is the most critical input of the project. Successful implementation of project activities including rapid response to outbreaks of diseases and efficient utilization of the computer hardware would largely depend on effectiveness of this specifically designed software. It is therefore proposed to select software agency through Quality & Cost Based Selection (weightage: technical 90% & financial 10%) QCBS – 90% & 10%). As per the procedure, TOR would be got cleared with the World Bank. Estimated cost of this component for entire period of the project is Rs. 75 million. d) Information, Education and Communication (IEC) Activities [Annexure 9, 9/I, 9/II] IEC activities would be carried out at district, state and national levels. Advertisement in newspapers is for public awareness to take preventive action against various target diseases. Therefore this activity should be funded as part of IEC services. Procedures proposed to be adopted at various levels are as follows: (i) District: Cost Estimates of each of the following activities are given in Annexure 9: Organization of sensitization workshops; Organization of review meetings of District Surveillance Committee; Publication of advertisement in local newspapers (selected on the basis of circulation); Printing of material (leaflets, brochures, formats for reporting etc.) would be undertaken by calling 3 or more proposals by giving advertisement in minimum 3 newspapers and 155 Indigenous methods (like street plays, puppet shows, weekly bazaars, drum beating), counseling and motivation of public through interpersonal communication. Most of these activities would be undertaken by single source or through NGOs. District Surveillance Units will arrange for these activities at peripheral level also. Costs include expenditure at district as well as peripheral levels. (ii) State: Cost Estimates of each of the following activities are given in Annexure 9. Organization of sensitization workshops; Organization of review meetings of State Surveillance Committee; Press Advertisement: By calling 3 or more proposals by giving advertisement in minimum 3 newspapers. Selection of newspapers would be based on circulation ratings in various languages; Print Media: by calling 3 or more proposals by giving advertisement in minimum 3 newspapers; Telecasting: Selection of channels would be based on viewers-ship ratings and reach. Services would be hired through Consultant Agencies following Quality & Cost Based Selection (QCBS) procedure; and Broadcasting: Selection of channels would be based on audience ratings and reach. Services would be hired through Consultant Agencies following Quality & Cost Based Selection (QCBS) procedure. (iii) National: Cost Estimates of each of the following activities are given in Annexure 9. Organization of workshops; Organization of National Surveillance Committee meetings and review meetings; Press Advertisement – Development of advertisements and thereafter publication of the same in national papers. Services would be hired through Consultant Agency following Quality & Cost Based Selection (QCBS) procedure; Print Media - Printing of Manuals, guidelines, training modules and other prototype materials would be undertaken at central level. For this activity Consultant Agency would be hired through Quality & Cost Based Selection (QCBS) procedure; Production of TV/Radio Spots - Services would be hired through Consultant Agency following Quality & Cost Based Selection (QCBS) procedure; and Telecast & Broadcast – Selection of channels would be based on viewers-ship ratings and reach. Services would be hired through Consultant Agency following Quality & Cost Based Selection (QCBS) procedure. State-wise and year-wise estimated costs for IEC are given at Annexure 9/I. Activity wise with year wise costs method to be adopted are given in Annexure 9/II 156 e) Evaluation Studies: [Annexure 10] Independent evaluation studies would be carried out during initial stage (baseline study), 3rd year (mid-term study) and in the final year (end-line study) of the project. These would include the following: Quality Assurance of Laboratory Services including Laboratory Waste Management Practices Survey on Risk Factors of Non Communicable Diseases Evaluation of training activities at various levels Effectiveness of Information Technology Cost benefit analysis of the project In all, 14 studies would be undertaken covering eight subjects as indicated in Annexure 10. These studies would be carried out through independent agencies, which would be selected through QCBS procedure at the Central level. Total estimated costs of evaluation studies would be Rs. 55 million. Year wise number of Evaluation Studies are given below: (Rs. in million) f) Year I Year II Year III Year IV Year V Study S.No. 1, 4 2, 5 3, 6, 9, 10 7 8, 11, 12, 13, 14 Districts Covered 41 38 141 20 220 Estimated Cost 7.05 6.90 19.05 6.00 16.00 Training [Annexure 11, 11/I] Training would be undertaken at various levels as per standard guidelines, curriculum and using prototype-training manual developed centrally. Main training courses to be undertaken during the project are as under: 157 i. Training of District & State Surveillance Teams, Laboratory Technician and Data Managers: These are the most important training courses and basically aim at developing capacities at various levels for undertaking disease surveillance and laboratory services. Such training courses would be organized in institutions that fulfill qualifying criteria and would be identified through QBS (Quality Based Selection). About 25 institutions will be hired for each training i.e. Laboratory Technicians, Data Managers and District/State Surveillance Teams. Thus there will be 75 packages for each year. The training would be independently evaluated through selected agency as described in Para 3(e) above. ii. Training of Medical Officers of PHCs & CHCs etc. This training would be organized by District Surveillance Units at the district level and conducted by members of District Surveillance Unit and other resource persons. This activity will not be out-sourced. iii. Training of Multipurpose Health Workers (MPW) and Lab. Assistants. Their training is job-related and interactive in nature and would be carried out by the selected Community Health Centres (CHCs) within each District. These CHCs would also be the peripheral nodal points for Disease Surveillance. This activity will not be out-sourced. Number of personnel to be trained and estimated costs are given below: (Rs. in million) Training Category MPW Lab. Assistant 2004-05 No. 66158 Costs 2005-06 No. 51.934 44836 Costs 2006-07 No. Costs 35.196 49159 38.590 on Training 125.72 1634 1.479 989 0.895 10894 19.990 6957 12.766 Lab. Technician 824 2.563 704 2.189 840 2.612 7.364 Data Managers 206 0.641 176 0.547 210 0.653 1.841 DST Team 824 5.727 704 4.893 840 5.838 16.458 SST Team 45 0.513 65 0.741 45 0.513 1.767 57.228 60174 64.186 204.261 Medical Officers Total 80585 82.846 54431 733 Total Costs 0.663 3.037 8347 15.317 48.073 Unit Costs for each type of training course has been computed at Annexure 11. State-wise & year-wise personnel to be trained and estimated costs are given at Table 11/I. g) Leasing of Wide Area Networking (WAN) [Annexure 12] Leasing of WAN will be in the years 2 to 5 as procurement of computer systems will start in year one. Hiring of agency for leasing of Wide Area Network for the project period will be 158 through Least Cost Selection procedure subject to the qualification parameters agreed to buy GOI and the World Bank. Estimated costs for leasing of lines are given in Annexure 12. 30.4 Incremental Operational Cost [Annexure 13 & 13/I] Maintenance of buildings will not be undertaken under the Project and this would be responsibility of the States/UTs. Other costs covered under this category are given below: Travel Costs, POL and maintenance of available Government vehicles used for Surveillance activities. In case Government vehicles are not available, hiring of vehicles by Direct Contracting at prevailing Government/market rates Maintenance of equipment, computer hardware and accessories (after warranty period) Allowances to staff including per diem during tours Expenditure on Telephone, fax, postage, courier, electricity and other services Office Stationery and other consumables items Other miscellaneous activities required for effective surveillance. Total estimated operational cost is Rs. 580.60 million. Details of operational costs for each unit are given in Annexure 13. State-wise and year-wise operational costs are given in Annexure 13/I. The state would be contributing a proportion of incremental operational costs on an increasing scale over the project period and assume the entire responsibility of this component after the project is over. This contribution will be guided by the following table : Project States Phase I Phase II Phase III Year 1 Year 2 Year 3 Year 4 Year 5 20% 20% 30% 40% 50% 20% 20% 30% 40% 20% 20% 30% 159 GOI would release the funds in two half-yearly installments to the state society on the basis of approved Annual Work Plan, the existing unspent balance, if any, and the funds to be provided by the state. The project states will fund from their resources, a part of incremental operational costs through the same fund flow mechanisms i.e. via the selected state society acceptable to GOI and IDA. 30.5 Prior Review Thresholds Following procurement of goods and services would be subject to prior review by the World Bank : All contracts for works with an estimated value of more than US $500,000 equivalent. Contracts for goods/equipment estimated to cost the equivalent of US $500,000 or more, provided, however, that subsequent contracts for the same goods/equipment with respect to which prior review has been carried out and completed in an earlier contract shall be subject to post review only. With respect to such subsequent contracts, the Borrower shall: (A) notify the Association of the initiation of the process for the procurement of goods/equipment; and (B) provide to the Association for its approval, any proposed changes to the bid documents from the earlier contract relating to the method of procurement, specifications, and qualifications and evaluation criteria. The first NCB contract for goods valued more than US $30,000 but less than US $500,000 equivalent. Consultant's contracts with an estimated value of US $100,000 equivalent or more for firms and US $50,000 equivalent or more for individuals, provided, however, subsequent contracts for the employment of consulting firms or individuals for the same type of activities with respect to which prior review has been carried out and completed in earlier contracts shall be subject to post review only. With respect to such subsequent contracts, the Borrower shall: (A) notify the Association of the initiation of the process for the selection of consultants; and (B) provide to the Association for its approval any proposed changes to the terms of reference, qualifications and experience of the consultants. 160 PART – IX FINANCIAL MANAGEMENT 161 31 FINANCIAL MANAGEMENT 31.1 Summary Project Description Disease surveillance has long been recognized as an important tool for measuring the disease burden, studying morbidity and mortality trends and early detection of outbreaks for instituting effective control measures in a timely manner. Though the health care infrastructure in our country has grown immensely over the years, disease surveillance system did not get the desired attention resulting in frequent outbreaks. The outbreaks of plague (1994), malaria (1995), and dengue haemorrhagic fever (1996) in different parts of the country further highlighted the weaknesses in the surveillance system and brought an urgency for its strengthening so that early warning signals of outbreaks are detected and appropriate preventive and control measures are applied timely to minimize the impact of the outbreak. The proposed five-year project would aim (i) to establish a decentralized state based system of surveillance for communicable and non-communicable diseases and their risk factors so that timely and effective public health actions can be initiated in response to health challenges in the country at the state and national levels and (ii) to improve the efficiency of the existing surveillance activities of disease control programs and facilitate sharing of relevant information with the health administration, community and other stakeholders so as to detect disease and risk factor trends over time and evaluate control strategies. The project will be coordinated by the Ministry of Health and Family Welfare (MOHFW), New Delhi. A Central Disease Surveillance Unit (CDSU) will be established for this purpose. It will also act as the Project Secretariat. This unit, which will report directly to both the Secretary for Health and the Secretary for Family Welfare, will be responsible for overall implementation of the project, its financial management, central level procurement, annual work-plans, management and technical support to the states and an annual progress review of the program. This cell would also include a senior level finance functionary of rank of Director/ Deputy Secretary who would be responsible for overseeing the Financial Management arrangements of the project. The Joint Secretary, MOHFW (Administrative Head) and the Deputy Director General (Technical Head), would have overall responsibility for the proposed project. The Project Secretariat would be assisted by a central procurement agent (national level), who would procure goods and equipment and consultancy services proposed to be financed under the project. The state departments will be responsible for implementation of the disease surveillance activities of the project in conformity with national guidelines. The states will establish a State Surveillance Unit (SSU) which integrates disease surveillance activities in the state and reports to the Secretary for Health and Family Welfare (or equivalent). The officer in-charge of SSU will be responsible for financial management of the project within the state, state level procurement, annual work plans management and technical support to the districts and annual progress review of the program in the state. 162 Implementation of the various disease surveillance activities at the district level will be funded through an identified & existing District Disease Control Society (or District Health Society) under the overall supervision of the State Department of Health and Family Welfare. The society will be responsible for district procurement and implementation of district annual work plans and financial management systems. The project is to be implemented in a phased manner (in three phases) as under: Phase I would cover nine States. These are Andhra Pradesh, Himachal Pradesh, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Mizoram, Tamil Nadu, and Uttaranchal. (Total number of districts in all the nine states - 206). Phase II would cover thirteen States. These are Chandigarh, Chhattisgarh, Delhi, Goa, Gujarat, Haryana, Manipur, Meghalaya, Orissa, Pondicherry, Rajasthan, Tripura, and West Bengal. (Total number of districts in all the thirteen states – 176). Phase III would also cover thirteen States. These are Arunachal Pradesh, Assam, Andaman & Nicobar Islands, Bihar, Daman & Diu Island, Dadra & Nager Haveli, Jammu & Kashmir, Jharkhand, Lakshadweep, Nagaland, Punjab, Sikkim and Uttar Pradesh. (Total number of districts in all the thirteen states - 210). The Phase I states have identified the state and district societies that are to be involved in the implementation of the project. These societies have been selected after a evaluation based on criteria developed by MOHFW and approved by IDA ( refer annexure 1). The states joining in the Phase II and III will also follow the same criteria for selection of the society at the state and district level for the implementation of the project. It is estimated that the World Bank assistance would be available for nearly 70-75% of the project costs. The remaining share would be from domestic budget. A provision of Rs. 260 crore has already been made for the tenth plan and this should be adequate to meet the domestic component of the project and thus there would be no additional financial implications on the domestic budget. As the funding from the WB is on reimbursement basis budget for both the receipt and the gross expenditure would need to be made. The proposed Integrated Disease Surveillance Project would be funded by Government of India for the duration of the project (2004-2009). 31.2 Implementing Agency: 163 31.2.1 Central level The Project would be implemented by Central Surveillance Unit (CSU) in the Directorate General of Health Services, Ministry of Health & FW, Government of India. This unit would execute decisions taken by National Disease Surveillance Committee which will be constituted as per Structure and Terms of References given in chapter on Administrative Structure Chapter20 of PIP/ Pages : 50-52). 31.2.2 State level The Project would be implemented by State Surveillance Unit (SSU) in the Directorate of Health Services of the States. This unit would execute decisions taken by State Disease Surveillance Committee which will be constituted as per Structure and Terms of References given in chapter on Administrative Structure (Chapter-20 of PIP/ Page : 53). 31.2.3 District level The Project would be implemented by District Surveillance Unit (DSU) under Chief Medical Officer of the District. This unit would execute decisions taken by the District Disease Surveillance Committee which will be constituted as per Structure and Terms of References given in chapter on Administrative Structure (Chapter-20 of PIP/ Pages : 55). 31.3 Finance Staffing and Training: For efficient Financial Management, dedicated personnel would be identified at the Central and State level. They would be engaged either through redeployment or on a consultancy basis. The finance wing of the project at the CSU would have one qualified finance professional, designated as Finance Consultant for the project and one other finance professional who is experienced in govt. accounting procedures. They would be responsible for establishment of the agreed financial management arrangements including Project Financial Management System (PFMS), providing timely financial reports to the stakeholders including the Bank, ensuring smooth and timely flow of funds and providing overall guidance in respect of the financial management issues for the project. The other members of the finance team would include 2 junior level accountants & and other support level staff as required under the project. At the state level a State Accountant (Finance Manager) will be hired on a competitive basis and shall meet the minimum skill set and TOR approved by IDA. At the district level, the officer dealing with parent society, through which funds would flow, would be given additional charge. He would be supported by Accountant, who should be computer literate, and a Data Entry Operator. Finance Managers at all levels would undergo training on Basic Finance Management and Accounting. To ensure uniformity and adoption of standard protocols, training in Finance Management would be a National level activity for central and State level Finance Managers who in turn would organize training of District level officers. Prototype training manual and operational guidelines for Finance Management would be developed for this activity. 164 32 BUDGETING The funding to the Integrated Disease Surveillance Project would be through the budget of the Ministry of Health and Family Welfare. A separate budget head would be allocated to the Project at the Central and State levels. At the National level, the account would be operated by the Central Disease Surveillance Unit, which is proposed to be headed by Joint Secretary (Administrative Head) and a Deputy Director General (Technical Head). Annual budget of the Project would be allocated as per National PIP with component-wise break up. Budget would be allocated to each State based on State PIP and utilization of funds released. 32.1 Funds Flow: Annual budget allocated to each State would be released only in two installments during the 1st and 3rd quarters of each Fiscal Year. Funds required to implement the Project will be released through existing State Health and Family Welfare Society or a disease specific State Society to ensure effective and efficient implementation of the Project. The State level society would release necessary funds to District level society twice a year. A resolution would be adopted by each society to incorporate IDSP funds management. Amount of installment would depend upon requirement and utilization of funds released earlier. To ensure adequate funds to Districts, mechanisms will be developed to regulate flow of funds. A minimum balance amount of Rs.100,000 would be sustained to meet any emergent situation. The funds flow to the various levels is described below: 32.1.1 Central level: At the central level, a special account will be maintained in the Reserve Bank of India and operated by the Department of Economic Affairs by the Government of India. The authorized allocation of the special account would represent six months of initial estimated disbursement of IDA credit. The reimbursement from the account would be made based on reimbursement claim submitted by the Government of India in agreed formats based on statements of expenditures received from states. After the reimbursement is given, the revolving credit would be recouped to the pre-existing level by the IDA. 32.1.2 State level State Disease Surveillance Committees would be formed in each state as per composition and Terms of References given in the chapter of Administrative Structure (Chapter-20 of PIP/ Page : 53) This would be an empowered committee to take major decisions including approval of annual plan of action. Under the umbrella of the State Level Societies, a separate bank account in the name of “State Surveillance Unit (name of State)” would be opened in a Nationalized Bank. Funds would be released by the State Finance Department as a cheque/demand draft. The books of accounts at the state level would be maintained using double entry book keeping principals. The State Surveillance Unit (SSU) would release funds to District Surveillance Units (Name of District) and other organizations/agencies, also by cheque/demand draft. SSU would maintain vouchers for the various receipts and expenditures. The Bank Account would be operated by at 165 least two of the three signatories, Chairperson, Vice-Chairperson and Member Secretary of State Surveillance Committee. 32.1.3 District level The District Surveillance Units will receive funds by cheque/demand draft from the SSU and a separate bank account would be operated under the umbrella of the existing District level Societies. The bank account will be operated by two of the three signatories: Chairperson, Vicechairperson and Member Secretary (District Surveillance Officer). Funds for the purpose of activities envisaged at the primary health center and CHC level would also be released at the district level itself and generally no flow of funds is envisaged at a lower level. Funds would generally not be managed below district level. If necessary, funds would be released to Community Health Centres as advances for training and other activities and accounts settled within 2 weeks of completion of activity. Transaction vouchers would be maintained for all receipts and expenditure by the District Surveillance Unit. 32.2 Books of account, accounting policies and procedure: The project costs incurred at the PCU and those incurred by the Central Procurement Agent (is there any) would be recorded in the books of the PCU at MoHFW in accordance with procedures and policies prescribed in the Finance manual. The accounting policies & procedures and the formats for existing financial reports for GoI are captured in the various accounting forms (‘Books of Forms’), cash book, the reports, the public works account code, the CPWD manual and General Financial Rules (GFR) as issued from time to time. These policies and procedures are exhaustive and capture the requirements of the A.G., Department of Finance and other stakeholders requiring financial information. These guidelines also lay down the internal control procedures and the formats of the reports and books of accounts. In spite of an well established system of accounting and reporting the expenditures, this system, however, has no established method for capturing physical information and integrating / linking it with the financial information. A Financial Management System (FMS), for the project, based on a manual system supported by the use of excel spreadsheets has been designed to accurately record and timely report the project expenditures at the aggregate project level within the overall reporting system as required within the government. Expenses would be recorded on a cash basis and would follow the government classifications, project components and activities for ease in reporting to various stakeholders. Standard books of accounts on a double entry basis (cash and bank books, journals, fixed assets register, ledgers, work registers, contractor registers etc.) will be maintained under the project by the PCU would be based on the existing Government accounting system with a modified focus on using the financial information and reports for managerial decision-making. A finance manual laying down the financial policies and procedures, periodic & annual reporting formats including financial statements, flow of information and methodology of compilation, budgeting & flow of funds, format of books of accounts, chart of accounts, information systems, 166 disbursement arrangements, external & internal audit for the project and operation of the Financial Management System (FMS) has been prepared for guiding the project personnel both at the CSU and the State and district Societies. The Financial manual is an integral part of the PIP. The FMS, inter alia, documents and encompass detailed accounting system (including the Chart of Accounts - accounting for GoI budget heads; formats of various financial and other reports that the department requires), internal control mechanisms, budgeting and forecasting system and the auditing arrangements for the project. A subsidiary chart of Accounts has been developed for the project as part of the Finance Manual to enable data to be captured and classified by expenditure center, budget heads, project components, activities and disbursement categories. Internal control systems would include: Establishment of small appropriate budgeting systems and regular monitoring of actual financial performance with budget and targets. Development and adoption of simple and transparent financial and accounting policies including identification of components and expenditures to be charged to the project, the categories under which expenditure would be charged and policies of transfer of funds and accounting of expenditures. The State unit will send a quarterly financial management reports which would include Comparison of budgeted and actual expenditure Analysis of major variances, including source and application of funds (by component and summarized expenditure categories) Progress in key physical parameters Forecasts of expenditure for next two quarters. 32.3 Information and Reporting System: The states will send detailed expenditure statements on a quarterly basis containing details of expenditure under the various heads by components and summarized expenditure categories to allow the Government of India to claim reimbursement from the World Bank. The releases to the State Government will be based upon receipts of State of Expenditure in agreed formats on a quarterly basis. At the district level, similar expenditure statements will be sent by the DSU on a quarterly basis to the State Surveillance Unit, in order to allow the State Government to submit the consolidated statement of expenditure to the Central Surveillance Unit. Formats for the Financial Monitoring Report (FMR) are given at Annexure 14. 32.4 Audit (External ) The IDSP accounts at Central Level will be audited by the Controller and the Auditor General of India (CAG). A TOR for this purpose has been approved by IDA and the consent of the CAG 167 has to be obtained for this purpose. The District and State Units will be audited by chartered accountant firms empanelled by the CAG/SAG based on the terms of reference approved by IDA. All the district audited financial statements will be consolidated into one single audited financial statement for the state . It is proposed that one auditor will be appointed at the state level for audit of all the District SU and State SU and such auditor will also be responsible for the audit of the consolidated financial statements. The auditor may engage another firm for the audit at the districts . This will provide independence of the auditor from the district SU where the bulk of the expenditure is to be incurred and also ensure uniformity in the reporting For large states with large number of districts joint auditors may be appointed with joint responsibility for consolidation. The detailed terms of reference and qualifications of the chartered accountants appointed to audit the State and District Level Units have been approved by the World Bank. The audit certificates and UCs of the district units will be sent to the state societies within 3 months of the closure of the financial year. Similarly the audit certificate and UCs of the State Societies will be sent to the central units within 6 months of the closure of the financial year. Release of funds from the central to the state level, and state to the district level would be incumbent on the receipt of the audit certificates and UCs. No further release of funds would be affected to the concerned units from central/ state level in case audit certificates and UCs are not received in time. 32.5 Internal Audit: As the project is widely spread (being implemented in all the 580 districts of the country) it will not be possible to have a meaningful and comprehensive internal audit. This is sought to be mitigated by means of developing a checklist against which six monthly review would be conducted by the state society accountant and also by supervision teams from the PMU and the IDA. This checklist would be made an integral part of the finance manual and included in the TOR (job responsibilities of the state accountant). 32.6 Retroactive Financing: Retroactive financing will be provided for project preparation and project expenditures amounting to approximately $2.00 million for expenditures incurred after April 1, 2003. The following activities would be eligible for retroactive financing - workshops, pilot testing of manuals, pilots for involvement of private practitioners, training, software development, baseline surveys, IEC, NGO activities and setting up the Central and State Surveillance Units. Bank guidelines and procedures will be followed for claiming retroactive financing. 32.7 Disbursement and Payment Arrangements:- 168 GOI would open a special account with RBI to receive the disbursements under the project from the Bank. Disbursement of funds from IDA would be based on actual expenditure incurred by implementing agencies. However, these would be subjected to audit reports and disallowances, if any, would be rectified. The disbursement would follow provisions of Credit Agreement between Government of India and the World Bank as summarized below : - Amount of the Credit Allocated % of Expenditure to be S.No. Category (Expressed in Financed SDR Equivalent) 1 Works 2,760,000 2 Goods 21,240,000 100% of foreign expenditures, 100% of local expenditures (exfactory cost) and 80% of local expenditures for other items procured locally 3 (a) Consultants’ services including 4,050,000 90% IEC, MIS and studies (other than services provided by tax-exempt providers) (b) Consultants’ services including 5,202,000 100% IEC, MIS and studies provided by tax-exempt providers, training and workshops 4 Incremental Operating Costs (a) For the Borrower and Project 3,600,000 80% until September 30, States executing Memorandum of 2006; 70% from October Understanding in Fiscal Year 20041, 2006 to September 30, 05 2007; 60% from October 1, 2007 to September 30, 2008 and 50% thereafter. (b) For Project States executing 3,080,000 80% until September 30, Memorandum of Understanding in 2007; 70% from October Fiscal Year 2005-06 1, 2007 to September 30, 2008; 60% thereafter (c) For Project States executing 80% until September 30, Memorandum of Understanding in 2008; 70% thereafter Fiscal Year 2006-07 5 Unallocated 4,700,000 TOTAL 46,900,000 169 A Special Account would be maintained in the Reserve Bank of India; and would be operated by the Department of Economic Affairs (DEA) of Government of India (GOI). The authorized allocation of the Special Account would be USD 6.8 million) from the IDA credit. The Special Account would be operated in accordance with the Bank’s operational policies. The project will submit withdrawal applications to Controller of Aid, Accounts and Audit (CAA&A) in DEA for onward submission to the Bank for replenishment of the special account or reimbursement. ANNEXURES 170