Document of The World Bank

FOR OFFICIAL USE ONLY

Report No: 25765-IN

PROJECT APPRAISAL DOCUMENT

ON A

PROPOSED IDA CREDIT

IN THE AMOUNT OF SDR 46.9 MILLION (US$68.0 MILLION EQUIVALENT)

TO THE

REPUBLIC OF INDIA

FOR AN

INTEGRATED DISEASE SURVEILLANCE PROJECT

June 7,2004

Human Development Unit South Asia Regional Office This document has a restricted distribution and may be used by recipients only in the performance o f their official duties. I t s contents may not otherwise be disclosed without World Bank authorization.

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AIDS CAS CBHI CD CDC csc csu DALY DFID DOTS DHSO D S U E M P GIS GO1 HIV HNP IAP IBRD ICDS I C M R IDA IDSP IEC IHD IMA INCLEN IndiaCLEN IT JRM M&E M O H M O H F W M O U N C D N G O NIB

CURRENCY EQUIVALENTS

(Exchange Rate Effective June 2004)

Currency Unit = Rupee Rupees 45.06 = US$1.0

FISCAL YEAR April 1 -- March 31

ABBREVIATIONS AND ACRONYMS

Acquired Immune Deficiency Syndrome Country Assistance Strategy Central Bureau o f Health Intelligence Communicable Diseases Centre for Disease Control Central Surveillance Committee Central Surveillance Unit Disability Adjusted L i f e Years Department for International Development Direct Observed Treatment, Shortcourse District Health Surveillance Officer District Surveillance Unit Environmental Management Plan Geographic Information System Government o f India Human Immune Deficiency Virus Health, Nutrition and Population Indian Association o f Paediatricians International Bank for Reconstruction and Development Integrated Child Development Services Indian Council for Medical Research International Development Association Integrated Disease Surveillance Project Information, Education, Communication Ischemic Heart Disease Indian Medical Association International Clinical Epidemiology Network Indian Clinical Epidemiology Network Information Technology Joint Review Mission Monitoring and Evaluation Ministry o f Health Ministry o f Health and Family Welfare Memorandum o f Understanding Non-Communicable Diseases Non Governmental Organization National Institute of Biologicals

FOR OFFICIAL USE ONLY

N I C D N P V NSPCD OP/BP P E M PHC PIP PRI R C H RRT SC/ST SHSP sso ssu STD TB UNICEF USAID WHO W M P

National Institute o f Communicable Diseases Net Present Value National Surveillance Project for Communicable Diseases Operational Policies/Bank Procedures Protein Energy Malnutrition Primary Health Centre Project Implementation Plan Panchayati Raj Institutions Reproductive and Child Health Rapid Response Team Schedule Castelschedule Tribe State Health Systems Project State Surveillance Officer State Surveillance Unit Sexually Transmitted Disease Tuberculosis United Nations Children's Fund US Agency for International Development World Health Organization Waste Management Plan

Vice President: Praful C. Pate1 Country Director: Michael F. Carter

Sector Director Julian Schweitzer Sector Manager: Anabela Abreu

Task Team Leader: Peter Heywood

This document has a restricted distribution and may be used by recipients only in the performance of their official duties. I t s contents may not be otherwise disclosed without W o r l d Bank authorization.

INDIA INTEGRATED DISEASE SURVEILLANCE PROJECT

CONTENTS

A. Project Development Objective

1. Project development objective 2. Key performance indicators

B. Strategic Context

1. Sector-related Country Assistance Strategy (CAS) goal supported by the project 2. Main sector issues and Government strategy 3. Sector issues to be addressed by the project and strategic choices

C. Project Description Summary

1. Project components 2. Key policy and institutional reforms supported by the project 3. Benefits and target population 4. Institutional and implementation arrangements

D. Project Rationale

1. Project alternatives considered and reasons for rejection 2. Major related projects financed by the Bank andor other development agencies 3. Lessons learned and reflected in the project design 4. Indications o f borrower commitment and ownership 5. Value added o f Bank support in this project

E. Summary Project Analysis

1. Economic 2. Financial 3. Technical 4. Institutional 5. Environmental 6. Social 7. Safeguard Policies

Page

2 2

2 3 3

8 9

10 10 11

11 13 13 14 16 17 19

F. Sustainability and Risks

1. Sustainability 19

2. Critical r isks 3. Possible controversial aspects

20 21

G. Main Conditions

1. Effectiveness Condition 2. Other

H. Readiness for Implementation

I. Compliance with Bank Policies

Annexes

Annex 1: Project Design Summary Annex 2: Detailed Project Description Annex 3: Estimated Project Costs Annex 4: Cost-Effectiveness Analysis Summary Annex 5: Financial Summary for Revenue-Earning Project Entities, or Financial Summary Annex 6: (A) Procurement Arrangements

(B) Financial Management and Disbursement Arrangements Annex 7: Project Processing Schedule Annex 8: Documents in the Project File Annex 9: Statement o f Loans and Credits Annex 10: Country at a Glance Annex 1 1 : Information Technology Annex 12: Training Strategy and Plan Annex 13: Quality Assurance o f Laboratory Data Annex 14: Existing Disease Surveillance Systems in India Annex 15: Institutional and Organizational Arrangements Annex 16: Strategy for Tribal Populations Annex 17: Environment Management Plan Annex 18: Strategy for involvement o f private sector in disease surveillance Annex 19: Supervision Plan

21 21

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22

23 27 38 39 43 44 55 62 63 64 68 70 74 81 86 88 91 96 99

102

INDIA Integrated Disease Surveillance Project

Project Appraisal Document South Asia Regional Office

SASHD

Date: June 7,2004 Sector Managermirector: Anabela Abreu Country Managermirector: Michael F. Carter Project ID: PO73651 Lending Instrument: Specific Investment Loan (SIL)

Team Leader: Peter F. Heywood Sector(s): Health (40%), Central government administration (20%), Sub-national government administration (20%), Information technology (1 5%), other industry (5%) Theme@): Other communicable diseases (P), Health system performance (P), Other human development (P), Decentralization (S)

For LoanslCred i tslOt hers: Amount (US$m): $68.0

Borrower: GOVERNMENT OF INDIA Responsible agency: MINISTRY OF HEALTH & FAMILY WELFARE Address: Nirman Bhavan, New Delhi. 110 001 Contact Person: Mr J.V.R. Prasada Rao, Secretary for Health. Tel: 91 11 23018863 Fax: 91 11 23014252 Email:

Project implementation period: 5 years Expected effectiveness date: 09/30/2004 Expected closing date: 09/30/2009

A. Project Development Objective

1. Project development objective: (see Annex 1)

The project development objective i s 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.

The proposed five-year project (to begin in 2004) w i l l support the longer-run program to consolidate and integrate disease surveillance in the country. The new integrated disease surveillance system will also put greater emphasis on building the l i n k s between the collection and analysis o f information and the actual on-the-ground interventions (medical or otherwise) by the public and private sectors. The long-run goal i s to effect a complete sh i f t from the present centrally driven, fragmented disease surveillance system, to an integrated disease surveillance and control program coordinated by the center but fully implemented by the states, districts and communities.

The project will assist the Government o f In&a and the States and Union Territories to: 0

0

0 improve laboratory support; 0 0

0

surveil a limited number o f health conditions and risk factors; strengthen data quality, analysis and l i n k s to action;

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.

2. K e y performance indicators: (see Annex 1)

Key aspects o f overall performance o f the surveillance system will be assessed using the following indicators:

0 Number and percentage o f districts providing monthly surveillance reports on time - by state and

0

0

0

0

0

overall; Number and percentage o f responses to disease-specific triggers on time - by state and overall; Number and percentage o f responses to disease-specific triggers assessed to be adequate - by state and overall; Number and percentage o f laboratories providing adequate quality o f information - by state and center; Number o f districts in which private providers are contributing to disease information; Number o f reports derived from private health care providers; Number o f reports derived from private laboratories; Number and percentage o f states in which surveillance information relating to various vertical disease control programs have been integrated under the Integrated Disease Surveillance Project (IDSP); Number and percentage o f project districts and states publishing annual surveillance reports within three months o f the end o f the fiscal year; publication by the Central Surveillance Unit (CSU) o f a consolidated annual surveillance report (print, electronic, including posting on websites) within three months o f the end o f fiscal year.

B. Strategic Context 1. Sector-related Country Assistance Strategy (CAS) goal supported by the project: (see Annex 1) Document number: R2002-0203[IDA/R2002-0177][IFC/R2002-0124] Date of latest CAS discussion: Dec. 5,2002

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The project i s consistent with the Bank Group Country Assistance Strategy (CAS) for India, last discussed by the Executive Directors on December 5,2002. The project would support the CAS objectives o f developing capacity to manage public health programs effectively and to aid in developing more efficient, effective and sustainable health systems at the state level that will better serve the needs o f the poor. The project emphasizes integration o f disease control by the center and the states for which a basic tool i s an integrated disease surveillance system. I t focuses on decentralization, building state capacity and involvement o f stakeholders such as local communities and the private sector, with the state and central governments, in an integrated surveillance effort.

2. Ma in sector issues and Government strategy:

The main sector issues as articulated in the Bank's India Health Nutrition and Population (HNP) Strategy, June 2001 are:

0

0

0

0

0

0 need to improve governance.

overall low health status o f the population, particularly the poor; inadequate institutional arrangements and weak program management; low quality o f HNP services in both the public and private sectors; need to improve targeting o f the public h d s to the poor; inadequate framework for engaging the private sector; low efficiency and limited financial resources;

These problems exist within a general institutional environment o f poor oversight and inadequate measurement o f health system inputs and outputs; improved disease surveillance will contribute to improved measurement o f health system outputs.

The Government strategy involves:

0

0

0 0

0

0 increased community involvement.

increased investments in economic growth and human development; decentralized planning and program implementation; integrating communicable, non-communicable and nutrition-related health services; convergence o f service delivery at the community level; increased collaboration with the private sector and NGOs;

3. Sector issues to be addressed by the project and strategic choices:

Surveillance i s the foundation o f an effective disease prevention and control program; it involves ongoing systematic collection, collation, analysis, and interpretation o f health data, closely integrated with the timely dissemination o f these data to those who need to know in order that action may be taken. A functional disease surveillance system i s useful for priority setting, planning, resource mobilization and allocation, prediction and early detection o f changes in disease pattems and monitoring and evaluation o f programs.

Disease surveillance in India in i t s present form i s an aggregation o f individual, disease-specific initiatives introduced over time. In addition, several other pilot projects are in operation. They include: a modification o f the current system in 100 districts under the leadership o f the National Institute o f Communicable Diseases (NICD) with support from World Health Organization (WHO); a pilot integrated system in North Arcot District o f Tamil Nadu; and, a pilot scheme for surveillance o f non-communicable diseases under the All-India Institute o f Medical Sciences. These pilots, which will now be incorporated

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into the IDSP, have underlined the need for a surveillance system that i s decentralized with clearly defined roles and ownership at all levels, and adequate staffing and training.

Partly as a result o f these disease surveillance and control efforts and other interventions, India has made major gains in control o f a number o f communicable diseases and overall health status o f i t s population has improved. Nevertheless, the disease burden o f the population remains high. At the same time, these control efforts, together with the associated demographic transition and increased l i fe expectancy mean that non-communicable diseases are now also an important cause o f death and disability. Overall, communicable diseases, maternal and prenatal conditions and nutritional deficiencies now account for only half o f the disability adjusted l ife years lost in India (down from 56 percent in 1990) and non-communicable disease accounts for 33 percent (up from 29 percent in 1990). As a consequence o f this change in disease pattern, the surveillance system does not cover some o f the important health conditions. Further, experience indicates that, overall, the disease surveillance system i s not working effectively - it i s not able to detect and respond to epidemics, nor i s it providing information on other important health conditions.

The surveillance system needs to change to respond to the changing health situation in India. The revised disease surveillance system will have the following important characteristics. First, it will cover a limited number o f health conditions o f public health importance, including some for w h c h an epidemic response capacity i s needed, and will also cover important non-communicable diseases as well.

Second, the system will use newer methods o f surveillance (e.g. sentinel sites, periodic surveys) where they are more efficient than the existing approaches.

Third, the system will be action oriented in a manner and at a level that i s specific to each o f the health conditions under surveillance. For example, for epidemic-prone diseases the emphasis will be on information collected at the local level from the private as well as the public providers and rapid actions based on decisions at the district and PHC level. In contrast, information on r isk factors for non-communicable diseases will be obtained through periodic surveys organized at the state level, and responses could occur on a time scale o f months rather than days.

Fourth, the system will be integrated, with the extent and nature o f integration varying with the level o f the system and the diseases concerned. In general, the aim i s to integrate new sources o f information (private providers, NGOs, laboratory test results - especially at the district level), integrate use o f resources (computers, communications infrastructure, personnel - especially at the district level), and integrate data analysis and reporting and dissemination (especially at the state and national levels).

Fifth, the system will use modem computer and communication technology. Sixth, the states will become increasingly responsible for the surveillance effort with the center responsible for coordination, policy setting and technical assistance. Seventh, there will be an overall emphasis on monitoring system performance, evolution and change in the system as needed, and on capacity building at all levels.

C. Project Description Summary 1. Project components (see Annex 2 for a detailed description and Annex 3 for a detailed cost breakdown):

T h i s five-year project will assist the central and state governments to sh i f t from a centrally driven, vertically organized disease surveillance system to one which i s coordinated by the center and implemented by the states, districts and communities. The project will be implemented in three phases. Phase I would

- 4 -

include the following nine States: Andhra Pradesh, Himachal Pradesh, Kamataka, Kerala, Madhya Pradesh, Maharashtra, Mizoram, Tamil Nadu and Uttaranchal. Phase I1 i s expected to include another thirteen States and Phase I11 the remaining States and Union Territories. The project has four components:

Component 1. Establish and Operate a Central-level Disease Surveillance Unit. Under this component, Ministry o f Health and Family Welfare (MOHFW) will establish a new Disease Surveillance Unit at the central level to help coordinate and decentralize disease surveillance activities. T h i s new unit will support and complement the states' disease surveillance efforts. The unit will be staffed by existing permanent s taf f reassigned from within the MOHFW. This component will address the constraints o f lack o f coordination despite central control o f surveillance activities and the need for changing the l i s t o f diseases included in the system. Effective coordination (as compared to control) o f disease surveillance activities depends on establishing the appropriate processes and institutional arrangements at the central level.

Component 2. Integrate and strengthen disease surveillance at the state and district levels. T h i s component addresses the constraints imposed by lack o f coordination at the sub-national levels, the limited use o f modem technology and data management techniques, the inability o f the system to act on information and the need for inclusion o f other stakeholders. I t 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. T h i s component will consist of: (i) upgrading laboratories at the state level, in order to improve laboratory support for surveillance activities. Adequate laboratory support i s essential for providing on-time and reliable confumation o f suspected cases; monitoring drug resistance; and monitoring changes in disease agents; (ii) introducing a quality assurance system for assessing and improving the quality o f laboratory data.

Component 4. Training for disease surveillance and action. The changes envisaged under the f i rst three components will require a large and coordinated training effort to reorient health staff to an integrated surveillance system and provide the new ski l ls needed. Training programs will include representatives from the private sector, NGOs and community groups.

Component 1. Establish and operate a central-level disease surveillance unit Component 2. Integrate and strengthen disease surveillance at the state and district levels Component 3. Improve laboratory support Component 4. Training for disease surveillance and action

Total Project Costs

2.63

56.47

26.57 2.97

88.64

3.0

63.7

30.0 3.4

100.0

2.02

40.54

22.67 2.77

68.00

3.0

59.6

33.3 4.1

100.0 Total Financing Required I 88.64 I 100.0 I 68.00 I 100.0 I

NOTE: The common set o f communicable diseases, non-communicable disease (NCD) risk factors, and environmental factors included in the surveillance system are: Malaria, Acute Diarrheal Disease (Cholera), Typhoid, Hepatitis, Measles, Polio, Plague, Tuberculosis, HIV/AIDS, hemorrhagic fevers, road accidents, water quality, outdoor air quality and N C D risk factors (height, weight, physical activity, blood pressure,

- 5 -

tobacco, nutrition and blindness; and any other unusual health condition GO1 may include in a public health emergency. The inclusion o f such additional diseases and related surveillance activities under the Project would be reviewed by the subsequent Joint Review Mission (JRh4). Such activities would be eligible for IDA financing until the subsequent JRM. The financing o f such activities by IDA beyond the JRM would depend on the recommendation o f the JRM.

2. Key policy and institutional reforms supported by the project:

Consistent with the HNP strategy for India the project supports the following key reforms: 0

0

0

0

rationalizing the l i s t o f diseases and risk conditions for surveillance as the number o f diseases presently under surveillance i s too large while at the same time important diseases are neglected; preparation o f national guidelines for disease surveillance, standardized case definitions for individual diseases and methods to be used for their surveillance; building capacity and ownership at the state level by decentralizing authority and responsibility to the states and districts; assigning high priority to public-private partnerships by actively recruiting private providers and laboratories to participate as sentinel sites.

3. Benefits and target population:

IDA credits extended to India over the last 20 years have helped make inroads into reducing the burden o f disease in the country. These credits have supported a range o f disease surveillance activities. The proposed IDA project would allow India to transform the existing vertically organized system to an integrated, more effective and action-oriented system which contributes to improved control o f major communicable and non-communicable diseases. Beyond the l i fe o f the project, this transformation would assist India to maintain a more effective disease surveillance system. Control o f these major diseases will generate substantial extemalities and the project will have a high social return in terms o f healthy l i fe years saved. These systemic improvements in overall disease control w i l l improve efficiency o f public sector management and coordination between the public sector, the private sector and the community - the benefits would accrue to the entire population.

Conversely, there are costs to not having an effective disease surveillance system. For example, the failure to detect and control the epidemic o f plague in 1994 at i t s early stages resulted in tragic loss o f l i fe as well as disruption o f trade, commerce, transportation and tourism - estimates o f the total cost are as high as US$ 1.5 billion; and the emergency and large scale response eventually required placed a heavy burden on the health system.

4. Institutional and implementation arrangements:

The project will be managed by the Ministry o f Health and Family Welfare (MOHFW) and implemented by the State Departments o f Health. Implementation arrangements will be as follows:

Central level: A Central Surveillance Unit (CSU), will be based in the MOHFW, and will be responsible for overall coordination, implementation and monitoring o f the surveillance program. I t s functions wi l l include: developing national guidelines for disease surveillance and control; monitoring the implementation o f the different components o f IDSP; ensuring implementation o f quality guidelines and standard operating procedures; analysis o f data and providing feedback on trends observed; coordinating responses to epidemics and disasters and any other requests received from states as necessary; coordinating the activities o f central agencies such as National Institute o f Communicable Diseases (NICD), Indian Council for Medical Research (ICMR) and referral laboratories under the program; coordinate external quality

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assurance activities; liaising with international public health organizations; and providing financial reports, reimbursement claims, and overall program progress reports to the World Bank.

The CSU will report to the Central Surveillance Committee which i s chaired by the two Health and Family Welfare Secretaries and has members representing Director General Health Services (DGHS), ICMR, NICD, National Institute o f Biologicals (NIB), representatives from the Min is t r ies o f Environment, Forest, Tribal Welfare, Agriculture, Rural and Urban Development, Water and Sanitation and NGOs - see Organigram in Annex 15. The committee wi l l meet quarterly to review the surveillance reports prepared by the CSU and as required during outbreaks and epidemics.

State level: State Surveillance Units (SSUs) will be established in each participating state and will be responsible for: collation and analysis o f data received from the districts and transmitting the same to the Central Surveillance Unit; sending regular feedback to the district units on the trend analysis o f data received from them; coordinating all training activities under the project; coordinating the activities o f the state Rapid Response Teams (RRTs) and dispatching them to the field as needed; monitoring and reviewing the activities o f District Surveillance Units (DSUs) including checks on validity o f data, responsiveness o f system and functioning o f laboratories; coordinating the activities o f state public health and medical college laboratories; implementing the extemal quality assurance program; and implementation o f risk factor surveys.

The SSU will report to the Secretary for Health and Family Welfare (or equivalent) and the State Surveillance Committee, an Empowered Committee responsible for coordination and policy making. See Organigram in Annex 15. This Committee will have Secretary Health as Chair, Director Public Health as co-chair and include: Program Officers for various health programs such as Reproductive and Child Health (RCH), AIDS, TB, Malaria etc, Department o f Finance, representatives from professional organizations such as the Indian Medical Association (IMA), NGOs. The committee will meet on a regular basis to review the surveillance reports prepared by the Surveillance Unit and as required during disasters and epidemics; it will also liaise with sister state committees to coordinate activities in case o f multi-jurisdictional outbreaks.

District level: The District Surveillance Units (DSUs) to be established at the district level, w i l l be the primary institutions collating data, analyzing data, and initiating outbreak investigations. These units will be responsible for: collation and analysis o f data received from the Community Health Centers (CHCs), Primary Health Centers (PHCs), laboratories, and private providers and transmitting the same to the State Surveillance Unit; sending regular feedback to reporting un i t s on the trend analysis o f data received from them; collection and trend analysis o f environmental hazard data; monitoring and reviewing the activities o f reporting uni ts including checks on validity o f data; initiating outbreak investigations and associated disease control measures; and facilitating public-private partnerships in outbreak response.

The DSU will report to the District Surveillance Committee chaired by the District Collector. See Organigram in Annex 15. T h i s committee will include representatives from other departments, local government and NGOs. The Committee will meet once a month and as needed during an epidemic; it will also liaise with sister district committees to coordinate activities in case o f multi-jurisdictional outbreaks. Reports o f these meetings will be forwarded to the State Surveillance Units. The Unit will be funded through a District Disease Control Society (or District Health Society) under the overall supervision o f the State Department o f Health and Family Welfare. The society will be responsible for district procurement and implementation o f district annual work plans and financial management systems

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Laboratories will analyze biological samples to confirm suspected cases o f infectious disease and to define population levels o f certain markers in the non-communicable disease risk factor surveys. There are four tiers o f Laboratories: Level 1 - PHC / CHC sub-district Laboratories; Level 2 - District Public Health Laboratories; Level 3 - State Public Health Laboratories; and Level 4 - Regional and National Public Health. Laboratories at each level will be responsible for confirming a sample o f the results o f tests performed at the next lowest tier and for quality assurance. In addition, the higher-level Laboratories will perform tests that are too complex or sensitive to be performed by the Level 1 Laboratories.

Private sector: Private health care providers and laboratories w i l l be encouraged to participate in IDSP as “sentinel” sites. Private providers will also be encouraged to participate in epidemic investigations and epidemic containment activities. They will report to the District Surveillance Units (DSUs). In tum, the DSUs will provide feedback to all reporting private providers, which will encourage them to more fully understand their importance in IDSP and maintain their motivation to continue. The Indian Medical Association (IMA) wi l l be a key intermediary in publicizing IDSP to i t s members and encouraging participants. Certificates will be provided as an incentive to participating private providers. In addition, feedback, information and further encouragement will also be provided through health bulletins and health information websites.

Local communities: Community organizations, including local government representatives from Panchayati Fbj Institutions (PRIs), will be encouraged to report new cases and participate in implementing disease control measures in cases o f outbreaks. They will also receive feedback from local health workers.

D. Project Rationale 1. Project alternatives considered and reasons for rejection:

The main project alternatives considered include: 1. Maintaining the status quo. This would mean continuation o f a number o f individual disease surveillance activities implemented through separate projects and programs, such as the various disease control projects and the State Health Systems Projects (SHSPs). As noted earlier, the current approach i s fragmented, ineffective and inefficient. A new approach needs to be developed which integrates the various surveillance activities with a revised role for the centre and states. 2. Sole responsibility of the Central Government. An alternative design was one in which disease surveillance was the sole responsibility o f the central government. Th is was rejected as the response to surveillance information has to be made at the state and district level and requires close involvement o f states in the surveillance system. 3. Sole responsibility of individual States. Withdrawal o f the central government from disease surveillance activities and complete decentralization o f disease control (including surveillance) to the states and districts. T h i s was rejected as there would be no standardization o f surveillance activities across the 35 StatesLJTs in the country. Central government involvement i s required for adoption o f a standardized approach to: disease case definitions; protocols for disease prevention and control actions; training and laboratory testing. In addition, there are international obligations which are best met by the central govemment rather than by individual state governments.

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2. Major related projects financed by the Bank and/or other development agencies (completed, ongoing and planned).

Bank-financed

System performance o f health care, improvements in quality, effectiveness and coverage o f health services at the first referral or secondary level to better

I

COMPLETED Andhra Pradesh First Referral Health System (Cr. 2663-IN closed on March 3 1,2002)

Sector Issue Project

serve the neediest section o f society.

Control o f Communicable Diseases

Strengthening institutional capacity; improving qaulity, coverage and effectiveness o f existing FW services, increasing access in selected disadvantaged districts and cities.

Implementation capacity o f the public health and the immunization program. Lack o f a coherent health system with well-defined public-private division o f responsibility, and under-funding of primary health care

Integrated Child Development Services I1 (Cr. 2470-IN, closet on September 30,2002) Second State Health Systems Development (Cr. 28334"

ONGOING

National Leprosy Elimination I 1 (Cr. 3482-IN Malaria Control (Cr. 2964-IN)

Maharashtra Health Systems Development (Cr. 3 149-IN)

Reproductive and Child Health Project (Cr. NO 1 8 4 "

Women and Child Developmen, (Cr. N042-IN)

Immunization Strengthening (Cr. 3340-IN) Orissa Health Systems (Cr. NO4 1 -IN)

2nd National HIV/AIDS (Cr.

Rajasthan Health Systems Development (Cr. 3867-IN) PIP EL IN E

3242-IN)

- inancec (Bank f' Implementation

Progress (IP)

H S

S

S

S

S

S

S

U S

U

S

Latest Supervision (PSR) Ratings

wojects only) Development

Objective (DO)

HS

S

HS

HS

S

S

S

U S

S

S

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Tamil Nadu State Health Systems

Other development agencies Wor ld Health Organization

Second Tuberculosis Control

National Surveillance Project for Communicable Diseases

3. Lessons learned and reflected in the project design:

The lessons learned derive f rom experience intemationally and in preparing and implementing seven disease control projects, f ive State Health Systems Projects (SHSP), Population VI11 & IX, Reproductive and Chi ld Health and Immunization Strengthening Projects, and recent health sector work. The main lessons, which are reflected in the project design adopted, are:

0

0

0

0

0

0 0

0

0

effective disease surveillance systems are critical for good management o f control programs and have positive effects wel l beyond the health system; the need to limit the number o f health conditions under surveillance with emphasis o n those which are o f public health significance; the value o f monitoring performance o f the surveillance system itself, an excellent example in India being the current pol io surveillance system; the need to include both the Department o f Health and the Department o f Family Welfare in an integrated disease surveillance system; the need to revise the relationship between the central and state govemments with coordination by the center and responsibility for implementation by the states; the importance o f including the community in disease control and surveillance activities; the importance o f motivating participation by the private sector in disease surveillance, as mandatory reporting could not be legislated or enforced in India at this time; the need for measurement o f disease and r i sk factors in management o f health systems; positive experiences f rom the SHSPs which include: community and primary health care response to the cyclone disaster; use o f Geographic Information System for mapping and rapid response in Andhra Pradesh; improved health system response derived from surveillance systems in Andhra Pradesh, Punjab, West Bengal and Maharashtra; positive experiences from the Brazi l and Argentina disease surveillance projects that illustrate the use o f data for action information in the Wor ld Bank's Disease Surveillance Toolkit o n principles o f surveillance, components o f an effective system, criteria for system evaluation, and resources.

0

0

4. Indications of borrower commitment and ownership:

There are strong indications o f borrower commitment and ownership.

Disease control i s one o f Government o f India's (GOI) priori ty interventions for the health sector as articulated in the National Health Policy, MOHFW, 2002. GO1 has recognized the problems with the current disease surveillance activities carried out through a series o f separate and vertical disease control programs and projects, and i s h l ly committed to revising and improving the surveillance system and to decentralizing implementation to the states. GOI's Tenth Five Year Plan has identified disease surveillance as an important aspect o f health sector activities and has allocated substantial resources for the integrated disease surveillance program.

A project preparation team representing.both the Departments o f Health and o f Family Welfare, led by an

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Additional Secretary has overseen project preparation. A series o f state level workshops on disease surveillance have been held (Tamil Nadu, Maharashtra and Uttar Pradesh) to explore the issues at the state, district and community levels. National level consultative meetings with various government agencies, donors and other partners have also been conducted as part o f the project preparation process. The lessons learned have been included in the project design. GO1 and the state governments organized consultations with a wide range o f stakeholders and conducted workshops before developing state specific project implementation plans.

5. Value added o f Bank support in this project:

Bank support for this proposed project will add value by bringing international experience and technical expertise - both the U.S. Centers o f Disease Control (CDC) and WHO have provided technical support for the preparation o f t h s project. In addition, the Bank i s playing a convening role by bringing together key agencies (National Institute for Communicable Disease (NICD), Indian Council for Medical Research (ICMR), WHO) who have been involved in pilot surveillance activities to collaborate and integrate their pilots into a nationwide surveillance system.

E. Summary Project Analysis (Detailed assessments are in the project file, see Annex 8)

1. Economic (see Annex 4): 0 Cost benefit 0 Cost effectiveness 0 Other (specify)

NPV=US$ million; ERR = % (see Annex 4)

BeneJits and Costs of the Project The costs to society o f the proposed new system for disease surveillance, which the project would support in i ts early years, would be the cost o f establishing the new system and subsequently the cost o f operating the system as per i t s design. For the project implementation period, the costs are summarized in Annex 3 and amount to about US$ 89 mil l ion for five years. The annual cost o f operating the system after project completion would be about US$ 7.0 million.

On the benefits side, the economic benefits that would accrue to society from the new surveillance system would take the form o f costs o f medical treatment saved by society, the value o f avoided lost earnings, and the value o f avoided years o f l i fe lost. These benefits would arise to the extent that the new surveillance system were able to either help prevent disease or contribute to a lower duration o f disease episodes andor lower treatment costs.

If benefits associated with the various diseases and risk factors covered by the new surveillance system could be quantified and aggregated, it would be possible to estimate the Net Present Value to society o f various possible designs o f the surveillance system. O n economic grounds, it would then make sense to choose the design with the highest N P V (assuming that at least some o f these NPVs are positive).

In practice, however, as explained in Annex 4, estimating such benefits would be very difficult. There i s a long chain o f l i n k s from setting up and operating a new system for disease surveillance to the actual economic benefits eventually resulting from those actions (see Annex 4 for more details).

In view o f the methodological difficulties involved and very limited information available, in the present case there were no attempts to quantify benefits. The Government’s design team was well aware, however, that in the fragmented system o f disease surveillance now in operation in India there are too many dseases

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which the different States attempt to track -- i.e., 95 in Tamil Nadu, and between 50-65 in most other States, and that the new system should only include a manageable subset o f these diseases. Hence the team adopted a pragmatic approach that combines a set of factors relevant to both the cost and benefit sides in order to make a selection and sharply reduce the number o f diseases to be placed under surveillance.

Specifically, the following selection criteria were taken into account for including a given disease in the new surveillance system. The presumption that a given disease should be included in the new surveillance system was greater:

the higher the impact o f the disease on the health o f the population (using Disability-Adjusted Life Years - DALYs - as the unit o f measurement); the higher the degree to which a disease i s amenable to cost-effective interventions for i ts prevention or treatment; the lower the cost o f surveillance; the greater the epidemic potential o f the disease; if the disease i s the subject o f specific regional or intemational control programs to which the government has subscribed.

0

0

0

0

Application o f these criteria resulted in the selection o f a l i s t o f 24 diseases to be included in the new surveillance system, o f which 16 are communicable diseases and the rest non-communicable diseases and road accidents. The complete l i s t i s shown in Annex 4, together with the respective methods o f surveillance and estimates o f the number o f annual deaths and o f DALYs lost in one year on account o f each disease.

The following examples illustrate how these criteria were applied in some concrete cases: Tuberculosis: This disease has a very high impact on the health o f the population; as shown in Table 1 in Annex 4, about 7.5 mill ion DALYs per year are lost because o f it. At the same time TB i s the subject o f specific, cost-effective interventions involving several international donors and has an established system o f surveillance already in place. Typhoid While the disease burden due to typhoid i s not known with any accuracy, states were unanimous in considering it a significant health problem with very great epidemic potential, w h c h they believed could be controlled more effectively if a good surveillance system was in place. The disease i s amenable to cost-effective interventions and there i s good potential for action provided better information i s available. Ischemic heart disease (IHD): I t i s evident from Table 1 that IHD i s the single most important disease burden for the population o f India - almost 12 mill ion DALYs are lost each year due to IHD. IHD has not been the subject o f surveillance before but it i s clear that if effective prevention and control programs are to be designed, information on the prevalence o f risk factors i s needed on a regular basis. This information can be collected very cheaply once a surveillance system i s set up. Given the stage o f the epidemic o f IHD in India, information collected has a very high probability o f leading to significant public health action.

Justification for Government Financing The services provided to society by a disease surveillance system -- basically the collection, interpretation and dissemination o f information on cases -- are in the nature o f a public good. The consumption o f these services by a given entity or household does not detract from consumption by other entities or households. Benefits accrue to the society at large, and if the Government did not take the initiative to pay for a disease surveillance system, the gap would not be filled by private business (the private sector could o f course be contracted by the Government to carry out some o f the activities in the surveillance system).

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2. Financial (see Annex 4 and Annex 5): NPV=US$ million; FRR = % (see Annex 4) Financial Management Issues Financial management issues are discussed in Section E.4.4 below and in Annex 6(B).

Financial Sustainability The burden o f recurrent government expenditure generated by the proposed project (salaries and other incremental operational costs, and the annualized cost o f repng capital goods) i s estimated at about US$ 7 mill ion per year after project completion, at which t ime these costs would be transfered to the States' health budget. This i s a very small amount by comparison with the total State government spending in the health sector, which i s currently about 0.75% o f GDP, or about US$3,500 million. So the answer to the question o f whether these expenditures would be sustained depends on the degree o f priority given to th i s particular program within the health sector in the years after project completion. I t i s likely though that disease surveillance would be given a high priority, because there i s increasing recognition among senior public officials and politicians at both the central and State levels that an adequate surveillance system i s a key component o f any organized health system. In addition, upon joining the Project, participating states wi l l fund from their resources a part o f the incremental operating costs not financed by IDA.

Fiscal Impact:

As indicated above, the fiscal impact will be negligible as the amount o f the recurrent costs estimated at about US$7 mill ion per year i s very small compared to the total government spending o f about US$2 bil l ion per year in the health sector.

3. Technical: A good public health surveillance system includes timely collection, reporting, analysis, and interpretation o f data; followed by dissemination o f the findings to those who need to know and actions taken for prevention and control o f diseases. The IDSP comprises all o f these components.

The project's technical dimensions are based on system assessment, laboratory infrastructure assessment, standard medical and health case definitions and protocols, and experience from other countries. The laboratory assessment was made with the support o f experts from the U S Centers for Disease Control and Prevention (CDC), and the assessment o f other current systems and needs was made by the India Clinical Epidemiology Network (IndiaCLEN) with the support o f the World Bank and the World Health Organization (WHO).

The disease case definitions were developed by a national committee o f infectious disease physicians. The committee began with case definitions published by either the World Health Organization (WHO) or by existing Indian national disease control programs, and refined them as appropriate for the Indian surveillance context. In instances where the final IDSP case definitions differ from W H O or previous Indian case definitions, the differences and reasons for them have been documented. States that opt to add additional conditions to the national core set will be expected to follow a similar process to finalize case definitions for those conditions.

The protocols for prevention and control o f epidemic-prone health conditions cover actions to be taken by field health workers, primary health center staff, district surveillance staff, public health laboratories, and state and national surveillance uni ts. The protocols are in line with accepted principles for surveillance, reporting, feedback, action, and safe disposal o f biomedical waste. The protocols include defined

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disease-specific case-count thresholds that w i l l trigger investigation and control measures for possible outbreaks.

The non-communicable disease risk factor surveys will employ sampling designs that enable relatively large amounts o f data representative o f the entire population to be gathered efficiently. The sampling procedures will be similar to those used in the international Demographic and Health Surveys, which are considered state-of-the-art.

Technical manuals have been developed by a team under the leadership o f IndiaCLEN which describe, in detail, the steps to be undertaken by each individual and organization in the surveillance and response chains. These manuals have been peer-reviewed by practitioners in-country and will be pilot-tested by selected Phase I states after Appraisal.

The success o f the project depends on adequate training o f a large number o f people. Most o f the people to be trained will be at the district level and below in both the public and private sectors. Following initial work by WHO, IndiaCLEN developed an extensive training program to meet the needs o f the system (see Annex 12). The training draws on the operations manuals and an assessment o f training needs as well as assessments o f the laboratory situation and environmental and social assessments. The training will be performed by institutions with national reputations for post-graduate education in public health and microbiology, and institutions with complementary ski l ls may work jointly. The effectiveness o f individual training courses will be assessed by annual third party evaluations. State training coordinators wi l l meet periodically to share experiences and ideas on ways in which the training can be improved. There wi l l be post-course follow-up and mentoring o f trainees.

The information technologylcommunications system will promote standardization o f data collection and minimize data errors, facilitate rapid reporting and response, allow the use o f GIS when needed, and allow health alerts to be rapidly disseminated to health workers and the public. N e w software for this purpose will be developed in the f irst year o f the project.

4. Institutional: A comprehensive institutional assessment was undertaken during project preparation and based on i t s recommendations, plus the lessons leamed from implementation o f previous projects, specific measures will be undertaken to decentralize activities and strengthen institutional capacity at centre and state level to implement the project. These measures include: (i) establishing a CSU in MOHFW with adequate capacity to: carry out overall coordination, implementation and monitoring o f IDSP; provide analysis, feedback and technical assistance to states; (ii) establishing SSUs and DSUs at the state and district level with resources to carry out surveillance functions o f collecting, reporting and analysis o f data followed by dissemination o f findings and actions for prevention and control o f disease; (iii) setting up a fund flow mechanism through State Societies to ensure adequate and timely release o f funds from centre to states; (iv) staffing the CSU, SSUs and DSUs with qualified financial personnel; (v) introducing modem computer and communications technology to speed up flows o f information and transform the surveillance system into an action-oriented system for timely response; (vi) introducing a quality assurance program carried out by independent third parties for improving the quality o f laboratory information; (vi) actively promoting involvement o f private health care providers and laboratories through a network o f sentinel sites.

4.1 Executing agencies:

The executing agencies will be M O H F W at the national level and Health Directorates at the state level. The MOHFW and many State Health Directorates have long experience in managing Bank-financed projects.

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4.2 Project management:

The project will be managed at the central level by the Central Surveillance Unit (CSU) and at the sub-national level by the State Surveillance Units (SSU) and District Surveillance Units (DSUs). T h i s structure, outlined in Annex 15 i s a key organizational reform and creates an institutional base for integrated surveillance activities and for IDSP at the center, state and district levels.

The project will be implemented in a phased manner to take into account the variations in state capacities. The rules o f engagement for each participating state are outlined in a Memorandum o f Understanding to be signed by state and the MOHFW. The Phase 1 will include a group o f nine states that have already demonstrated staffing and implementation readiness. These are: Andhra Pradesh, Himachal Pradesh, Kamataka, Kerala, Madhya Pradesh, Maharashtra, Mizoram, Tamil Nadu and Uttaranchal. Phase I1 will add about thirteen states as they meet project entry criteria. A final Phase I11 will include the remaining group o f states requiring even greater previous management upgrades. The three phases combined will cover the whole country. During the project period, specific measures such as provision o f technical assistance to states, inter-state exchanges and sharing o f best practices will be undertaken to support states and motivate them to meet entry criteria.

4.3 Procurement issues:

Guidelines for Procurement under IBRD Loans and IDA Credits (January 1995, revised in January and August 1996 and in September 1997 and January 1999) would apply to all goods and works financed under the project. The Guidelines for Selection and Employment o f Consultants by World Bank Borrowers (January 1997, revised in September 1997, January 1999 and May 2002) would apply to al l consultants' services financed under the project.

Civil works in this project involve renovation, repair o f existing laboratories and surveillance units, at Peripheral, District, State, and Central level. The project does not envisage any new construction activity. Other goods and services that would be procured under the proposed project include laboratory reagents, chemicals, and other consumables including glass ware, furniture, lab equipment, office equipment, computer hardware, readily available application and system software, training and studies, contractual services, procurement agents, software development, IEC activities, and contracts for NGO services.

Procurement o f small items o f low value would be at DistricUState level. Remaining items would be procured at the central level using National Competitive Bidding (NCB) and Intemational Competitive Bidding (ICB) through a procurement agent.

Procurement i s discussed in more detail in Annex 6(A).

4.4 Financial management issues:

This i s the f irst project that would be implemented by the Central Surveillance Unit (CSU) (under the MOHFW). The proposed financial management arrangements are detailed in annex 6 (B). Approximately 30 percent o f the expenditure under the project would be incurred at the center. The funds at the central level would be made available to the line ministry (MOHFW) through separate identifiable budget heads in the Union Budget. The funds f low for the project costs to be incurred at the states and the districts (where over 70 percent o f the costs are to be incurred) will be directly routed through identified healWdisease control societies. The 9 Phase I States have already identified societies and completed an Financial Management checklist..

The Director or Deputy Secretary in the Finance Division o f the MOHFW would overlook the financial

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matters o f the Project. He would be assisted by one full-time qualified finance consultant for the project and one other finance professional experienced in government accounting procedures. At the state level a State Accountant (Finance Consultant) w i l l be contracted on a competitive basis and would meet the minimum s k i l l s set and experience acceptable to IDA.

The project costs incurred at the CSU and those incurred by the Central Procurement Agent would be recorded in the books of the CSU at MOHFW in accordance with procedures and policies prescribed in the Finance manual. A Financial Management System (FMS) for the project, based on a manual system (with support by way o f excel spreadsheets) has been designed to accurately record and timely report the project expenditures at the aggregate project level. Expenses would be recorded on a cash basis and would follow broadly the government classifications, project components and activities for ease in reporting to various stakeholders. Standard books o f accounts on a double entry basis (cash and bank books, journals, fixed assets register, ledgers, work registers, contractor registers etc.) w i l l be maintained under the project by the CSU and the state and district societies. A finance manual laying down the financial policies and procedures, periodic and annual reporting formats including financial statements/FMR's, f low o f information and methodology o f compilation, budgeting and flow o f funds, format o f books o f accounts, chart o f accounts, information systems, disbursement arrangements, internal control mechanisms, external and internal audit for the project and operation o f the Financial Management System (FMS) has been prepared for guiding the project personnel.

Under the proposed audit arrangements, the project would be required to submit the following sets o f annual audit reports to the Bank (36 audit reports): (i) an audit report in respect o f the central CSU at MOHFW (including project financial statement - sources and uses o f funds) audited by C&AG; (ii) one consolidated audit report (including project financial statement) for each state. Th is consolidation at the state level will be based on the individual audit reports received from the district societies.

5. Environmental: Environmental Category: B (Partial Assessment) 5.1 Summarize the steps undertaken for environmental assessment and EMP preparation (including consultation and disclosure) and the significant issues and their treatment emerging from this analysis.

Environmental Assessment (EA). Since the project will support the renovation and upgrading o f public health laboratories, the main environmental impact i s associated with waste generated by these Laboratories carry out testing for infectious and contagious diseases, such as malaria, typhoid, cholera and hepatitis, tuberculosis and HIVIAIDS and generate waste which includes infected human tissues, blood samples, microbes, discarded chemicals, sharps, etc. Such waste, if not managed properly, carries the risk o f infection for waste handlers and to the larger community and i s also a potential environmental hazard, through pollution o f land, water and ground water. W h i l e the amount o f waste generated from such laboratories i s small, i t s varied and hazardous composition requires comprehensive management o f the waste lifecycle, from source to disposal, to prevent adverse impacts on the environment and public health.

During project preparation an international expert team from the US Centers for Disease Control (CDC) undertook a baseline assessment o f the laboratory system in January 2002, o f three states (Tamil Nadu, Maharashtra and Uttar Pradesh) and reviewed the laboratory waste management practices. T h i s assessment indicated that while there i s some awareness o f medical waste regulations among the laboratory staff at state, district or peripheral laboratories, there i s a need to enhance knowledge and practice o f medical waste disposal and related environmental impacts, and to strengthen biosafety in the laboratories and management o f laboratory waste.

The MOHFW has prepared an Environmental Management Plan (EMP), adopted in M a y 2003, the summary o f which i s found in Annex 17, which identifies the main environmental and public health

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impacts from public health laboratories and actions to be taken to reduce the r isks and impacts. The project should have a positive environmental impact as specific laboratories will be upgraded in terms o f their operational procedures, including purchase, storage and handling o f chemicals and management (storage and disposal) o f wastes.

Land acquisition N o land acquisition i s envisaged as laboratory renovatiodupgrading would take place on land already in the possession o f the Government.

5.2 What are the main features o f the EMP and are they adequate?

The Environmental Management Plan (EMP) includes an outline Standard Operating Procedures (SOPS) for good practice management and mitigation measures for the various types o f wastes expected to be generated in laboratory operations. The EMP also includes an implementation framework for introducing the appropriate SOP at various state levels, and a monitoring framework. The implementation details will be developed during project implementation. To refine the implementation arrangements, all states will conduct a baseline assessment in the f i rst year o f the project, to assess the type o f waste generated at each laboratory and i t s management from source to disposal. The MOHFW i s developing Operational Manuals, one o f which i s for Laboratory Technicians, and this will incorporate the SOP. Further details o f the EMP are given in Annex 17.

5.3 For Category A and B projects, timeline and status o f EA: Date o f receipt o f final draft: May 2003

5.4 How have stakeholders been consulted at the stage o f (a) environmental screening and (b) draft EA report on the environmental impacts and proposed environment management plan? Describe mechanisms o f consultation that were used and which groups were consulted?

During project preparation and the baseline assessment, consultations were held with officials from national and state government departments, medical and research institutions and laboratories. The discussions revealed the need for individual states to establish waste management guidelines and systems for effective implementation and monitoring.

5.5 What mechanisms have been established to monitor and evaluate the impact o f the project on the environment? D o the indicators reflect the objectives and results o f the EMP?

The Central Surveillance Unit at the MOHFW and the SSUs and the DSUs will be responsible for the overall project implementation and monitoring o f various components, including the EMP. Monitoring systems will also be put in place to ensure compliance with prescribed guidelines for waste management. In addition to the regular supervision missions by the Bank, GO1 will undertake independent evaluations o f EMP implementation.

6. Social: 6.1 Summarize key social issues relevant to the project objectives, and specify the project's social development outcomes.

Engaging communities, especially vulnerable groups including women, ST/SC groups, the poor and populations in remote areas, in detection, reporting o f disease conditions and eliciting appropriate response from the health system, i s critical to achieving the project's objective o f improving the efficiency o f the existing surveillance activities o f disease control programs. Facilitating the sharing o f relevant information and feedback with the community i s critical to their participation in disease surveillance and in instilling in them the confidence that the exercise i s beneficial to them.

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The planned social development outcomes o f the project are: 0

0

0

0

strengthened link between communities and the health system leading to greater credibility o f the health system; increased disease identification and reporting by communities by overcoming socio-cultural barriers and gender differentials; improved health awareness for disease prevention and treatment; improved surveillance o f the health o f the poor.

Women: The project seeks to address gender barriers by (i) social mobilization involving women self-help groups and organizations such as mahila mandals; (ii) “engendering” o f sensitization and training programs for field level staff planned under the project; and (iii) IEC campaigns that effectively address women’s needs. Scheduled Tribes: The project has outlined a strategy to reach tribal populations in remote tribal areas and guide project implementation. Scheduled Castes; Poor, and Migratory Groups: The project recognizes the need for focusing on these vulnerable groups through social mobilization initiatives as well as directed mass media and local publicity.

6.2 Participatory Approach: H o w are key stakeholders participating in the project?

During preparation, workshops and focus groups discussions were held in Phase I states and the national level with major stakeholders identified by the project in urban and rural areas. These include:

Field workers such as the Anganwadi Workers in villages and urban wards, teachers, local health committees, elected representatives (Panchayat Raj Institutions - PRIs), self help groups, youth groups, NGOs. Medical college staff, private practitioners, and owners o f hospitals/nursing homes. Block, district, state and national level administration and program staff.

0

0

0

Consultations will be ongoing through the project’s implementation and monitoring activities.

6.3 How does the project involve consultations or collaboration with NGOs or other civil society organizations?

In order to better understand the basic principles that would govern community involvement in surveillance and the elements for setting up community-based surveillance systems on a pilot basis under the project, in-depth interaction and discussions were carried out with a number o f NGOs, medical colleges, medical professionals, professional associations, and other agencies.

6.4 What institutional arrangements have been provided to ensure the project achieves i t s social development outcomes?

Decentralization o f disease surveillance mechanisms to the state, district and community levels will: (a) increase interaction between the health system and the community; (b) enhance community knowledge o f disease and control measures; and (c) improve monitoring and tracking o f the disease burden o f vulnerable groups.

For example, in both rural and urban areas, community-based information will be a key input to the DSU that will coordinate analysis and action.

6.5 How will the project monitor performance in terms o f social development outcomes?

The project will monitor increased knowledge o f communities and their involvement in surveillance activities. Community monitoring 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

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communities, especially vulnerable groups.

7. Safeguard Policies:

I

7.2 Describe provisions made by the project to ensure compliance with applicable safeguard policies.

Two safeguard policies are triggered by this project: (1) Environmental Assessment discussed in 5.1 and addressed by an Environmental Management Plan and (2) Indigenous Peoples discussed below and addressed by the Strategy for Tribal Populations, IDSP (May 2003) .

Indigenous Peoples (OD 4.20). There are approximately 68 mill ion Scheduled Tribe people, constituting about 8 percent o f India's population. They are spread out all over the country and the project PIPS identify these tribal populations as a target group requiring special culturally-sensitive strategies. For this project, the MOHFW has adopted the Strategy for Tribal Populations, IDSP, (May 2003) (see Annex 16) which seeks to increase outreach to the tribal areas, provide culturally compatible IEC, and train volunteers - tribal youth - as community mobilizers and communicators. I t was developed based on extensive interactions with tribal communities, with specific focus on women, NGOs working with tribals, other stakeholders including Health Department officials, medical professionals, medical colleges, and private providers. This Strategy i s consistent with the Draft National Policy on Tribals, recently proposed by the Government o f India.

F. Sustainability and Risks 1. Sustainability:

The project i s technically sound, has a low recurrent cost and aims to involve a much wider range o f stakeholders (with emphasis on the community level and the private sector) than has been the case in the past. In addition, specific uni ts with responsibility for integrated disease surveillance to be created at the national, state and district levels will relieve important institutional constraints. However, the most important condition for sustainability i s successful implementation o f the project and demonstration o f the utility o f a well-functioning disease surveillance system. For this to occur it i s vital that the national and state governments together with the Bank mount a technically and administratively effective project supervision effort - it i s this collaboration which will determine the success o f the project and, ultimately, i t s sustainability.

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2. Critical R i s k s (reflecting the failure o f critical assumptions found in the fourth column o f Annex 1):

M

M

M

M

H

S

Risk From Outputs to Objective GO1 and states not willing to undertake changes in roles and responsibilities under proposed decentralization and integration andor do not have the capacity to do so.

GO1 and the states have all agreed to take on the roles defined in IDSP. T h i s agreement i s described in detail in the Memorandum o f Understanding (MOU) between GO1 and each state. The IDSP entails regular and frequent communication among the different levels (central, state, and district) and there w i l l thus be a constant expectation for each level to respond to both the level above and the level below. World Bank supervision will also be a method o f helping to ensure that GO1 fu l f i l l s i t s role and receives cooperation from the states. Preparation o f the states to be included in the next phase o f the project will commence a year ahead o f the date on which they are scheduled to enter the project. Many o f the factors likely to slow down preparation o f states for inclusion in the project have been identified during project preparation and this w i l l assist in ensuring that states entering in Phases 2 and 3 o f the project are ready on time. Significant and ongoing training will be delivered to s ta f f at all levels. Districts wi l l receive direction and technical support from States. Relationships with medical societies and community groups will facilitate networking with the private sector and communities. Participation will be encouraged by giving communities ongoing feedback about local disease trends, and by actively seeking their participation in disease control activities. Participation will be encouraged by giving providers training and ongoing feedback about local disease trends, making health information available to them through bulletins and websites, and by actively seeking their participation and support for disease control activities.

CSU will closely monitor the financial aspects and will be adequately staffed with experienced personnel for this purpose. I t has been agreed that at least one qualified finance professional with identified s k i l l s set w i l l be employed in the CSU. The job responsibility has also been

The project will not expand at the rate proposed in the phased approach with the result that the project will not implemented on the scale intended.

Districts do not have the skills, resources and authority to move to an action-oriented surveillance system and are unwi l l inghable to involve villages and the private sector

Communities have inadequate incentives to contribute on an ongoing basis

Private sector has inadequate incentives to actively contribute to the system on an ongoing basis

From Components to Outputs A large number o f districts (590) and states (35) will be required to account for and report on the expenditure under the project. Similarly audit reports o f numerous districts would need to be consolidated by each state society. There

Risk Rating I Risk Mitigation Measure

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s a hgh likelihood o f inconsistency in the ormat o f reporting in the financial tatements and in the audit opinions. Also lelays in submission o f audited financial tatements i s a common occurrence in entrally sponsored projects

.ack o f suitably qualified finance staf f vith the necessary skil ls set and :xperience at the state societies may lamper the f low o f finance information SOE/FMR and audit reports) as also a ack o f guidance to the district .ccountants.

Ielayed procurement

Ielayed assignment o f staff and :onsultants herall Risk Rating

Risk Rating - H (High Risk), S (Substantial Ri:

3. Possible Controversial Aspects:

None identified.

G. Main Loan Conditions 1. Effectiveness Condition

None

S

M

M

M , M (Modest Risk), F

defined. Formats for monthly reporting o f expenditures will be developed and included in the financial manual. TOR for the audit and the format o f opinion have been approved which wi l l be included in the finance manual. In order to reduce the inconsistency in reporting, it has been agreed that one auditor (two in case o f large states with numerous districts) w i l l be appointed for the audit o f all the districts and the state society and will be paid for by the state society. This will ensure uniformity in reporting and consistent quality o f audit.

A TOR and s k i l l set have been agreed with the CSU based on which accountants (Finance Consultants) will be hired for the state societies on a competitive basis. The TOR also defines the control responsibility o f the state accountant over the district accountant.

Procurement plans; relevant procurement actions were conditions o f negotiations.

Processing staff and consultant appointments were conditions o f negotiations

Negligible or Low Risk)

2. Other [classify according to covenant types used in the Legal Agreements.]

1. The Borrower shall maintain the Project Implementation Plan, the Tribal Development Plan and the Environment Management Plan and carry out the Project in accordance with such Plans.

2. The Borrower shall ensure that the following structures are established and maintained over the project period: CSU, CSC, SSUs and DSUs.

3. The Borrower shall ensure that qualified Financial Consultants are appointed at the national and state- level and ensure that these positions remain filled throughout the implementation o f the Project.

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- .

4. No disbursement shall be made to any State until i t has entered into a Memorandum o f Understanding (MOU) with the MOHFW regarding project implementation.

H. Readiness for Implementation 0 1. a) The engineering design documents for the f r s t year's activities are complete and ready for the start

o f project implementation. iXi 1. b) Not applicable.

H 2. The procurement documents for the f i rst year's activities are complete and ready for the start o f

ixI 3. The Project Implementation Plan has been appraised and found to be realistic and o f satisfactory

0 4. The following items are lacking and are discussed under loan conditions (Section G):

project implementation.

quality.

I. Compliance with Bank Policies

1. This project complies with all applicable Bank policies. 0 2. The following exceptions to Bank policies are recommended for approval. The project complies with

all other applicable Bank policies.

Peter F. Heywood An bela Abreu Michael F. Carter Team Leader - L Sector Manager Country ManagerlDirector

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jector-related CAS Goal: -0 develop the capacity to nanage public health programs ffectively

Voject Development 1 bjective: :o improve the information rvailable to the government iealth services and private iealth care providers on a set )f high-priority diseases and isk factors, with a view to mproving the on-the-ground esponses to such diseases and isk factors.

Annex 1 : Project Design Summary INDIA: Integrated Disease Surveillance Project

Key Performance I Data Collection Strategy 1 Sector Indicators: Sector/ country reports: (from Goal to Bank Mission) (i) under-5 mortality rate; (ii) National Family Health Survey Improved management of public matemal mortality rate; (iii) NSSO surveys health programs will contribute nutritional status o f under-5s; (iv) RCH survey to poverty reduction in India contraceptive prevalence rate. Al l UNICEF MICS in relation to the MDG goals.

SRS

Outcome / Impact Project reports: (from Objective to Goal) Indicators: # and % of districts providing monthly surveillance reports on central level translate into better time - by state and overall. # and % of responses to central level programs. disease-specific triggers on time - by state and overall. # and % responses to disease-specific triggers assessed to be adequate - by state and overall. # and % o f laboratories providing adequate quality o f information - by state and overall. # o f reports derived from private providers. # of reports derived from private laboratories. # and % o f 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 o f the end of fiscal year

MOHFW reports at state and

MOHFW reports at state and

Periodic independent third-party surveys o f a

months. Third-party survey in Years 1, 3 and 5.

Improved information does

management o f public health

Of 'responses' each

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Iutput from each :omponent: 2omponent 1 - Establish and iperate a Central-level >isease Surveillance Unit

Iomponent 2. Integrate and trengthen disease urveillance at the state and listrict levels a) State level establish SSUs linked via I T

ietwork to CSU support districts in gathering nd entering information on ime support districts in timely esponse to disease-specific riggers

b) District level - 'HCs/CHCs ensure that district level

.ctions take place on time, iarticularly training, QA, nstallation o f network; support reporting units in

;athering and entering nformation on time respond to disease-specific riggers promptly promote participation by irivate providers and aboratories

c) Community level provide information to eporting units on disease evels and unusual health vents

Output Indicators:

CSU established and functioning with adequate staff and I T hardware.

IT software developed, operating and national network established.

Central reports on national disease situation produced on time.

Number o f SSUs established with adequate staff, IT hardwarehoftware, l inked to national network.

Number and % responses to disease-specific triggers assessed to be adequate.

Number o f districts l inked to the state and national disease surveillance network.

Number o f DSUs established with assigned staff and operating IT system.

Number and % responses to disease-specific triggers assessed to be adequate.

Number o f private health care providers contributing to surveillance reports.

Yumber o f villageshrban wards reporting occurrence o f iealth events.

'roject reports:

:entral unit reports 3ank reports ipecial surveys and ssessments

:entral unit reports itate unit reports 3ank reports ipecial surveys and ssessments

itate reports I istr ict reports

itate reports I istr ict reports

4

from Outputs to Objective)

2entral unit has required nanagerial and technical :apacity

3 0 1 willing to adopt new .ales

:enter has the capacity to irovide support and technical issistance to the states

States willing to integrate iisease surveillance activities

States and districts willing to nvolve communities and the Jrivate sector

District and state units have idequate skills, resources and mthority to respond Private sector has adequate incentive to participate

Communities and private sector have adequate incentives to participate

- 24 -

Zomponent 3 - Improve aboratory support # o f laboratories to be

,enovated/upgraded # o f laboratories to be

:quipped - implementation o f quality issurance program

' design, implement, evaluate, ind modify (as necessary) raining programs to improve urveillance activities

Somponent 4 - Training for lisease surveillance and iction

outbreak investigation 0 useofsoftware 0 specific lab assays,

quality control methods and reporting formats

Quality o f training - % o f third-party assessments favorable.

# and % o f district, state and national laboratories providing adequate quality o f information in a timely manner.

# o f reports derived from private laboratories.

# o f quality assurance surveys completed.

Number o f staff trained in 0 general orientation 0 disease surveillance

epidemiology and

I

Zentral unit reports State unit reports 3ank reports jpecial surveys and issessments

Sentral unit reports state unit reports 3ank reports Special surveys and issessments

.aboratory information is

.vailable in a timely manner md integrated into the urveillance system ,aboratory information is o f :ood quality

- 25 -

Voject Components I Sub-components: I. Establish and operate a 2entral-level Disease Surveillance Unit Integrate and strengthen iisease surveillance at the itate and district levels ;takehold 1. Improve laboratory

i. Training for disease ;urveillance and action.

nputs: (budget for each :omponent) JSD 2.63 M i l l i on

JSD 56.47 M i l l i on

JSD 26.57 M i l l i on

JSD 2.97 M i l l i on

'roject reports:

quarterly project reports

Supervision reports Special surveys

3upervision reports Special surveys

Supervision reports Special surveys

ns from Components to lutputs) idequate and timely flow o f unds from GO1 to the states

idequate and timely flow o f unds from the states to the listricts

rimely assignment o f staff md consultants; equipment Iurchased, staff trained, QA iurveys implemented r imely procurement :valuation and assessment o f raining

- 26 -

Annex 2: Detailed Project Description INDIA: Integrated Disease Surveillance Project

Project Development Objective

The project development objective i s 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. The proposed five-year project (to begin in FY 2004/05) would support the f i rst phase o f a longer-run program to consolidate and integrate disease surveillance in the country. The new integrated disease surveillance system would also put greater emphasis on building the l i n k s between the collection and analysis o f information and the actual on-the-ground interventions (medical or otherwise) by the public and private sectors. The long-run goal i s to effect a complete sh i f t from the present centrally driven, fragmented disease surveillance system, to an integrated disease surveillance and control program coordinated by the center but fully implemented by the states, districts and communities.

The project would build on the activities commenced by GO1 and selected states under the National Surveillance Project for Communicable Diseases (NSPCD) and the State Health Systems projects. Funding for NSPCD, which i s being implemented in 100 districts across India, will cease at the end o f the current fiscal year and these activities will now be included in the IDSP. Additional surveillance activities at the state level are being funded through the various State Health Systems Projects. As these projects close, the surveillance activities will also be included under IDSP. For example, surveillance activities in Maharashtra are being funded in a number o f districts through the IDA-supported Maharashtra State Health Systems Development Project (MSHSDP). When MSHSDP closes in 2005, all surveillance activities in the state will be consolidated in the IDSP. Similarly, other states will now fund activities previously supported by NSPCD andor State Health Systems Projects through IDSP. Nevertheless, surveillance activities under both IDSP and the various State Health Systems projects will adopt IDSP procedures straight away (as specified in the respective state Project Implementation Plans and Memorandum o f Understanding). The procedures to be used for this project will be those already in use where at all possible. For example, for TB and HIV/AIDS, the case definitions and reporting procedures will be those already in use in the respective control programs; they will build on what i s already there and provide a sound basis for a truly integrated disease program to evolve over time.

Deficiencies in the Present Disease Surveillance System

As already noted, the present system is fragmented. There i s no overall management structure for the disease surveillance activities at the center. Similar administrative fragmentation exists at the state, district and health facility levels as well. The result i s duplication o f activities, inefficient use o f resources and, overall, a failure to share information between disease control programs.

Surveillance activities are centrally controlled through the MOHFW and the role of other players is limited. Resources for the disease control programs have been guaranteed through central funding. Th is has resulted in central control, and limited capacities and involvement by the states. Involvement o f states and districts i s largely as collectors o f information who forward i t to the center, which then makes program decisions that are transmitted to the states, who are then expected to take the actions specified by the center. Moreover, private medical practitioners and NGOs active in the provision o f health care are not involved in disease surveillance. In fact, the surveillance system relies almost totally on the public health system as a

- 27 -

source o f information. T h i s i s a critical limitation as the private sector in India provides more than 80% o f outpatient care. Hence th is failure to involve private providers, particularly as sources o f information on disease outbreaks, seriously limits the validity o f surveillance information.

The number of diseases under surveillance is much too large while at the same time important diseases have been neglected. Most o f the disease information collected at the periphery i s at the behest o f the center; in addition, most states also collect some disease information for their own purposes. The result i s that there are too many diseases which the different states attempt to track (i.e., 95 in Tamil Nadu, and between 50-65 in most other States). At the same time, the present surveillance system provides insufficient information on a number o f diseases which have a high disease burden. Amongst the communicable diseases these include acute respiratory infections and diarrhea. And with the exception o f malnutrition, the current system does not provide information on any non-communicable diseases.

Laboratory support for surveillance is often inadequate. Good laboratory support i s an essential input into a disease surveillance system, especially with regard to communicable diseases. At present the effectiveness o f laboratory support i s very uneven for different diseases and across states. Moreover, the transition to the new surveillance system will entail the creation o f additional demands for laboratory support. The most important aspects o f laboratory support that will need to be strengthened are testing for typhoid, cholera and water quality. In addition to provision o f equipment, reagents and test ki ts, the project will also support training and quality assurance activities for laboratory information - the quality assurance activities will also include the diagnostic tests for TB and malaria, the actual equipment and reagents for which are supported under existing Bank projects.

Data management and analysis are deficient. Data management and analysis are largely carried out at the central level. While some early initiatives are being undertaken in some states, overall there i s little, if any, capacity for either data management or analysis at the state and district levels. Data management, analysis, reporting and dissemination makes only limited use o f computer-based technology and modem communications. These deficiencies result in flows o f information to states and districts which often arrive too late for the corresponding authorities to take effective action. This i s a major problem, since often t ime i s o f the essence -- especially in cases o f epidemic outbreaks.

Most important of all, the present surveillance system is not action oriented and it is not able to prompt effective and timely responses to disease outbreaks. Currently, some states have epidemic investigation teams to respond to disease outbreaks established under the National Surveillance Project for Communicable Disease (NSPCD) which i s piloted in 100 districts throughout India. The teams have not been effective as there i s a delay between information collection at the local level, data entry and analysis, and decision to take action. In addition, as there i s no structure at any level within which the surveillance activities are carried out there i s no one responsible for organizing, maintaining and implementing response mechanisms. A timely response needs local analysis o f information, clear decision rules and the ability to respond at the local and district levels - someone needs to be responsible for assessing the information that comes in and, when necessary, initiating a response; th i s mechanism does not exist at any level at the moment. The new project will provide real time entry and analysis o f data at the district level together with a clear structure and staff responsible for disease surveillance at district, state and central levels. The combination o f new technology and th is new structure w i l l greatly improve the ability to make an effective response.

What Will the Project Do?

The project proposed here will provide assistance for the initial steps needed to address the above

- 28 -

deficiencies and initiate the transition to the new integrated disease surveillance system. The project will be instrumental in revising the role o f the center and states; decentralizing responsibility for implementation o f disease surveillance activities to the states and districts; involving the community and private health care sector; rationalizing the l i s t o f diseases and risk conditions for surveillance; promoting integration o f disease surveillance activities; strengthening and integrating support laboratories; introducing modem computer and communications technology to speed up flows o f information; and -- most important -- transforming the surveillance system into an action-oriented system that ensures effective and timely responses to the health challenges revealed by the surveillance system.

Scope of the New Integrated Disease Surveillance Project

One o f the most important aspects o f the new surveillance system i s the rationalization o f the l is t o f diseases and risk conditions to be surveyed. As part o f project preparation, in-depth discussions between the MOHFW and the states resulted in a manageably short core l ist o f 21 diseases (of which 16 are communicable diseases and five are non-communicable diseases), plus road injuries, water and air quality, and anti-microbials resistance. The complete l i s t i s attached as Appendix 1 to th i s Annex. The criteria utilized to arrive at the core l i s t are explained in Annex 4 (economic analysis).

Project Phasing

The project will be implemented in phases. To th i s effect, all the states and Union Territories have been divided in three groups:

1. Phase I states, which will implement IDSP beginning in FY2004-05 (GOI's fiscal year), are Andhra Pradesh, Himachal Pradesh, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Tamil Nadu, Mizoram, and Uttaranchal.

2. Phase I1 statesAJTs, which will implement IDSP beginning in FY2005-06, are expected to be Chhattisgarh, Goa, Gujarat, Haryana, Rajasthan, Uttaranchal, West Bengal, Manipur, Meghalaya, Orissa, Tripura, Chandigarh, Pondicherry, and Delhi.

3. Phase I11 statesAJTs, which will implement IDSP beginning in FY2006-07, are expected to be Uttar Pradesh, Bihar, Jammu & Kashmir, Jharkhand, Punjab, Arunachal Pradesh, Assam, Nagaland, Sikkim, Andaman & Nicobar, D & N Haveli, Daman & Diu, and Lakshadweep.

Response to the Surveillance Information

By establishing surveillance units at the district, state and national levels the project provides, for the f i rst 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 o f suspected cases in a specified time and location) for each o f the diseaseshealth conditions under surveillance. The responses to be made when each o f these trigger levels i s crossed for one o f 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 o f these actions i s shown in the table below. Details for each o f the diseases are given in the District Operations Manuals for the project.

The software to be developed in th i s project will alert district level s ta f f when the triggers have been crossed and w i l l also send information to the state if appropriate action by the districts i s not notified within a specific time.

- 29 -

For non-communicable diseases the situation i s different - the frequency o f collecting information i s lower, the response time i s longer and the interventions o f a different nature. The surveillance information i s 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.

Routine Trigger for Action Activities 0 monitoring o f illnesses 0 suspected case count (continuous) above disease specific action 0 syndromic threshold specified for the reporting to CHC condition (weekly) 0 unusual syndrome causing 0 refer patients to PHC I death or hospitalization CHC

verification o f local 0 suspected I confirmed case iealth worker case reports count above disease-specific weekly) action threshold verification o f laboratory 0 notification from D S U o f

eports (weekly) apparent outbreak feedback to local health

vorkers (weekly)

data entry o f sentinel data. confirmed case count

I Action

0 inform M O PHC/CHC 0 active search for similar cases 0 collection and transport o f biological samples to lat 0 I E C for public 0 integration with non health personnel in the

verification o f reports o f outbreaks from health worker (within 24 hours). 0 verification o f reports o f outbreaks in the rumor registry (within 48 hours) 0 disease-specific control activities (immediately) 0 collection and transport o f biological samples to la1 0 reporting o f suspected and confirmed cases to D S U (within 24 hours) 0 IEC and integration with village health committee 0 outbreak investigation under D S U direction 0 initiate outbreak

community

1. Local Health Worker

rom institutions not linked lindicating local outbreak

2. C H C M O I

investigation through Rapi Response Teams (RRT)

PHC M O

0 provide coordination to outbreak response activitie involving CHCs 0 initiate disease control measures and treatment 0 notify SSU 0 facilitate private /public partnership in outbreak response

3. District Surveillance UniUCommittees

I

lirectly (weekly) analysis including

alculation o f case counts nd descriptive pidemiology (weekly) monitoring and

valuation including assess ccuracy and completeness I f submitted reports weekly) collection and trend

- 30 -

4. State Surveillance UnitlCommittees

analysis o f water quality, air quality, and road accident data 0 reporting to SSU

0 integration and facilitation information flow to district program managers. 0 feedback to reporting units (weekly) 0 outreach to community organizations 0 compilation o f DSU reports (monthly) 0 assess reporting performance o f DSUs

0 reporting to CSU (monthly) 0 feedback to DSUs (monthly) 0 implementation o f risk factor surveys (every 3

0 plan and implement risk factor control campaigns based on survey information 0 coordination o f training activities 0 implementation o f external quality assurance program for labs 0 coordinate activities with other relevant state

(weekly)

(monthly)

Yeas)

confirmed case count ndicating multifocal lutbreak or pandemic

UnitlCommittees

agencies

definitions and disease 0 international health threat control potentially affecting India 0 oversight and direction o f IDSP 0 compilation and analysis o f SSU reports

0 coordination o f regional and central labs

(quarterly)

advise DSUs on disease ontrol measures monitor situation and

:sponse (continuously) notify CSU deployment o f state rapic

zsponse team if necessary

1 advise SSUs on disease :ontrol measures 1 monitor situation and 'esponse (continuously) 1 notify international mblic health agencies

seek and coordinate nternational assistance if iecessary

- 31 -

reporting to international public health agencies (for selected conditions) 0 feedback to SSUs

0 reporting to World Bank 0 coordinate external quality assurance activities

(quarterly)

Annual Surveillance Reports Publication o f annual surveillance reports by district, State and Centre Surveillance Units would be disseminated to al l Stakeholders including leading private providers. Besides specific information o n occurrence o f 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 o f the important objectives o f IDSP i s to integrate surveillance activities carried out under various vertical disease control programmes. To facilitate integration, the project envisages various activities l ike data generation using uniform and common reporting formats, integrated training o f health workers, common mode o f transmission, collection compilation and analysis o f 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.

By Component:

Project Component 1 - US$2.63 million

Establish and Operate a Central-level Disease Surveillance Unit

Under this component, M O H F W 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 s taf f 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 o f the unit which will include:

preparation o f national guidelines for dsease 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. 0

- 32 -

e

e

e

e

providing overall support to states and coordinating national surveillance activities, including the preparation o f a national plan o f action. coordination and timely transport o f specimens to the regional, national and international reference laboratories. data analysis to identify epidemiological trends and preparation o f national reports on the epidemiological situation. coordination o f Quality Assurance surveys (in conjunction with the states).

The project will finance consultants, equipment and h i t u r e and incremental operating costs.

Project Component 2 - US$56.47 million

Integrate and strengthen disease surveillance at the state and district levels (involving communities and other stakeholders, in particular the private sector). This component addresses the constraints imposed by lack o f coordination at the sub-national levels, the limited use o f modem technology and data management techniques, the inability o f the system to act on information and the need for inclusion o f other stakeholders. I t wi l l consist o f 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 wi l l also hire 3 technical consultants and 4 support staff. Emphasis will be on strengthening integration o f the activities o f existing health staff, laboratory information, the private sector and the community into the overall system through implementation o f procedures and activities spelt out in the district-level and state-level disease surveillance manuals.

Activities at the state level will include:

e e e e e e

e

preparing and sending monthly summaries o f the disease situation to the central level; training state and district level staff; implementing periodic surveys for non-communicable diseases andor their risk factors; implementing Quality Assurance surveys (in conjunction with GOI); integration o f disease control efforts based on the surveillance data; supporting districts in data analysis, transport o f 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 andor epidemiology. Other contract staff will include a microbiologist and 4 support staff, including data entry operators. Activities will include:

e e e e e

analyzing surveillance data from the peripheral level; providing support for collection and transport o f specimens to laboratory networks; initiating investigation o f suspected cases; providing feedback to the health facility; responding promptly to information provided by communities.

(c) Community level: Activities will include:

e notifying the nearest health facility o f a disease or health condition selected for community-based

- 33 -

surveillance supporting health workers during case or outbreak investigations using feedback from health workers to take action, including health education and coordination o f community participation.

0

e

(d) Strengthen data quality, analysis and links to action: Activities will include:

e

e

e

0

0

'real-time' on-line entry, management and analysis o f surveillance data through use o f 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 o f 'health alerts' and other textual information; and electronic distribution o f reports both to the public health staff and civil society; Quality Assurance surveys o f laboratory information.

The Information Technology aspects o f the project will involve setting up a network to transfer data between various levels o f the system, provision o f stand alone computers at the district level and l i nks to district, state and national units. Software for the system will be developed to facilitate simplified data entry with multilingual formats, analysis and consolidation o f data at each level, generation o f alerts on the basis o f disease-specific thresholds, documentation o f the system and development o f manuals, phased deployment o f software, sk i l ls assessment o f staff and provision o f appropriate training.

Further details o f the Information Technology element o f the project are given in Annex 1 1.

The project will support incremental operating costs, purchase o f services from NGOs, consultants, computers, development and purchase o f software, technical assistance, strengthening o f electronic communication between the districts, states and center, IEC materials and media space.

Project Component 3 - US$ 26.57 million

Improve Laboratory Support

This component would consist o f (i) The upgrading o f laboratories at the state level, in order to improve laboratory support for surveillance activities. Adequate laboratory support i s essential for providing on-time and reliable confirmation o f suspected cases; monitoring drug resistance; and monitoring changes in disease agents; and

(ii) The introduction o f a quality assurance system for assessing and improving the quality o f 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 o f malaria, TB, typhoid, chlorination levels in water and fecal contamination o f water. Whi ls t these laboratories already handle examination o f sputum and blood smears, some need minor internal modification as well as the provision o f k i t s for typhoid diagnosis and assessment o f fecal contamination o f water.

- 34 -

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 ki ts. These laboratories will also be connected to the computer network. Staff will be as already assigned, reassigned from other laboratories or, in the case o f 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 o f the internal quality control mechanism, and assays required for the non-communicable disease surveys. The project provides for some minor internal modification o f laboratories, equipment required for additional tests, reagents and ki ts, 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) o f laboratory data are an important tool in improving the quality o f 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 for the assay and assessment to a sample o f 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 o f Reference for these surveys are set out in Annex. 13.

The component would finance renovation o f existing buildings, purchase o f equipment, technical assistance, incremental operating costs. and surveys.

Project Component 4 - US$2.97 million

Training for Disease Surveillance and Action

The changes envisaged under the f irst three components will require a large and coordinated training effort to reorient health staff to an integrated surveillance system and provide the new ski l ls needed. T h i s component will support

0

0

0 specialized training in epidemiology; 0

general training for orientation o f staff in both the public and private sectors to disease surveillance; specific training for disease control staff;

specialized training in data management and communications.

The training strategy and plan for the project i s based on a training needs assessment carried out in 6 states. Eight separate short term training programs for various categories o f 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:

- 35 -

Trainees Training ( central, di and state surveillan teams

vledical0 t f the PHC :HCs and lealth sec vlos o f lor vledical cc dOs o f N( vlission H

vledical0 If the Hos jubdistricl lospitals, vIedical C lospitals

MPWs (M ;emale), € Supervisoi Jolunteers mnregisterc Medical xactitionc

State and level nicrobiolc lab technic 4 1 ~ 0 o f thi health sec Also

Content of Training Overview and introduction to surveillance with

special reference to IDSP. 0 Basic epidemiology pertaining to surveillance including definitions l ike rates, ratios, Incidence Rate, Prevalence Rate, spot maps, graphs etc. 0 Details o f case detection, including case definitions, reporting units and filling up forms, compilation and transmission o f data

Collection and transmission o f laboratory specimens and bio-safety issues

Details o f analysis and interpretation o f data Details on response to outbreaks Supervision Monitoring and Evaluation .

0 Feedback Training methodology Inter-sectoral coordination Cluster survey sampling and analysis methods

(state team only) Overview and introduction to surveillance with

pecial reference to IDSP. Details o f case detection, including case

lefinitions, reporting units and filling up forms, ompilation and transmission o f data

Collection and transmission o f laboratory pecimens and bio-safety issues 1 Basics o f analysis and interpretation o f data 1 Details o n response to outbreaks 1 Supervision Monitoring and Evaluation. 1 Overview and introduction to surveillance with pecial reference to IDSP. 1 Details o f case detection, including case lefinitions, reporting units and filling up forms, :ompilation and transmission o f data 1 Basics o f lab confirmation - what specimens to b lent to which lab, and in what manner for :onfirmation 1 Overview and introduction to surveillance 1 Syndrome description I Filling up o f forms 1 Transmission o f data 1 Collection o f specimens 1 Biosafety issues b Basic response to outbreaks b Overview and introduction to surveillance with ipecial reference to IDSP 1 Hands on training on diagnosis o f specific iiseases. Especially culture and sensitivity of stool m d blood, serology etc. b Quality assurance mechanisms 1 Biosafety issues

{umber to be trained 2523

19298

6900

- 36 -

Microbiologists from local Medical Colleges

assistants at CHC e Testing for sputum AFB, Malarial smear, I PHC Typhoid test

11 Training for lab Introduction to IDSP

e Collection, storage and transportation o f specimens e Biosafety issues

VI1 Training for Introduction to IDSP I data Extracting o f data from the computers

management at district and state level

e Analysis o f data

The Training Strategy and Plan for the project are shown in Annex 12. The project will finance workshops, review meetings, training activities, contractual services and operating expenses.

3356

592

- 37 -

Annex 3: Estimated Project Costs INDIA Integrated Disease Surveillance Project

1. Establish and Operate a Central-level Disease

2. Integrate and Strengthen Disease Surveillance at the State

3. Improve Laboratory Support 4. Training for Disease Surveillance and Action Total Baseline Cost

Physical Contingencies Price Contingencies

Surveillance Unit

and District Levels

2.26

46.16

19.25 2.57

70.24 2.28 6.63

0.05

4.47

4.19 0.00 8.71 0.43 0.35

Total Project Cost: 79.15 9.49

Total Financing Required 79.15 9.49

Goods Works Consultant Services Training and Workshops ConsultantlStaff Fees Operations and Maintenance Physical Contingencies Price Contingencies

Total Project Cost: Total Financing Required

27.54 4.71 9.53 3.82

10.89 13.75 2.28 6.63

2.3 1

50.63

23.44 2.57

78.95 2.71 6.98

88.64

88.64

8.52 0.00 0.19 0.00 0.00 0.00 0.43 0.35

36.06 4.7 1 9.72 3.82

10.89 13.75 2.71 6.98

79.15 I 9.49 I 88.64

79.15 I 9.49 I 88.64

I Identifiable taxes and duties are 0 (US$m) and the total project cost, net o f taxes, i s 88.64 (US$m). Therefore, the project cost sharing ratio i s 76.7 1% of

total project cost net o f taxes.

- 38 -

Annex 4: Cost Effectiveness Analysis Summary INDIA: Integrated Disease Surveillance Project

Summary o f benefits and costs:

The costs to society o f the proposed new system for disease surveillance, which the project would support in i ts early years, would be the cost o f establishing the new system and subsequently the cost o f operating the system as per i t s design. These costs are summarized in Annex 3 for the project period. The annual cost o f maintaining and operating the system after project completion would be about US$7 million. Though undoubtedly there would be a degree o f error in the cost estimates, estimation o f the costs i s relatively straightfonvard.

2. On the benefits side, the economic benefits that would accrue to society from the new surveillance system would take the form o f costs o f medical treatment saved by society, the value o f avoided lost earnings, and the value o f avoided years o f l i fe lost. These benefits would arise to the extent that the new surveillance system were able to either help prevent disease or contribute or a lower duration o f disease episodes and/or lower treatment costs. Two examples are given here, Japanese encephalitis and typhoid:

(a) The surveillance system would lead to the following benefits in the case o f Japanese encephalitis (E), an infectious disease due to a virus transmitted to humans from domesticated and wild animals and birds through mosquito bites. A health system which i s alert to the presence o f E will detect new cases more rapidly allowing clusters o f the disease to be identified and appropriate management commenced earlier than would have been the case otherwise. This, in turn, will reduce the likelihood o f serious sequelae. At the same time, recognition o f clusters and the number o f cases exceeding the triggers will lead to earlier vector control activities and reduced transmission thus lowering the number o f cases and/or more rapid detection and treatment.

(b) Surveillance for typhoid illustrates benefits for a disease that i s transmitted v ia contaminated food and water. Whenever the number o f new caes exceeds the disease surveillance's trigger levels, the public health authorities (in cooperation with private practitioners, who would be informed through mass media) will start paying greater attention to possible cases o f typhoid, and as a result, there would be a greater likelihood o f early case detection. Early detection, in turn, will lead to more prompt treatment, which may result in a 10-fold reduction in the case-fatality and a concomitant reduction in clinical complications. In addition, public authorities and households are likely to start putting a greater emphasis on the need for safe drinking water and sanitary disposal o f human waste leading to the prevention o f many cases.

3. In practice, however, estimating such benefits would be very difficult. There i s a long chain o f l inks from setting up and operating a new system for the surveillance o f a given disease or risk factor and the actual economic benefits eventually resulting from those actions. For any economic benefits to materialize, it would be necessary that:

0

0

0

the surveillance system actually collects reasonably accurate information on the disease in question as per i t s design; someone processes such information into meaningful reports and makes sure that the reports get to those who are in a position to use them for policy and management purposes; the reports result in effective action taken by the relevant decision makers in the public or private sector, which changes the delivery o f services on the ground in a way that results in the prevention o f a number o f cases o f the disease, or in a more efficient mode o f treatment for those who are

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afflicted.

4. This implies that in order to estimate the new system's economic benefits it would be necessary to make judgements about how well these successive l i n k s are likely to perform over the years. Only then it would be possible to start quantifying the types o f benefits noted in para 2 above. The cost o f the interventions themselves (for prevention or treatment o f the disease) would, o f course, have to subtracted from the benefits.

5. If benefits associated with the various diseases and the r isk factors covered by the new surveillance system could be quantified and aggregated, it would be possible to estimate the Net Present Value (NPV) to society o f various possible designs o f the surveillance system. O n economic grounds, it would then make sense to choose the design with the highest NPV (assuming that at least some o f these NPVs are positive).

6. In most cases o f introduction o f a new surveillance system, it i s likely that benefits (and costs) o f the various design options cannot be quantified, e.g., because o f missing information, or disagreements among designers o f the system about the expected operations o f the l inks connecting program activities to benefits.

7. In the case o f the new surveillance system outlined in th is report, the design team (which also included representatives o f the Central government and the States) did not attempt to quantify economic benefits. The design team was well aware that in the current, fragmented system o f disease surveillance in India there are too many diseases which the different states attempt to track (Le., 95 in Tamil Nadu, and between 50 - 65 in most other States), and that the new system should only include a manageable subset o f these diseases. Hence the design team adopted a pragmatic approach that combines a set o f factors relevant to both the cost and benefits side in order to greatly reduce the number o f diseases under surveillance.

8. Specifically, the following criteria were taken into account in the selection o f diseases for inclusion in the new surveillance system. The presumption that a given disease should be included in the new surveillance system was greater:

0

0

0 0

0

the higher the impact o f the disease on the health o f the population (using Disability - Adjusted Li fe Years --Days-- as the unit o f measurement); the higher the degree to which a disease i s amenable to cost - effective interventions for i ts prevention or treatment; the lower the cost o f surveillance; the greater the epidemic potential o f the disease; if the disease i s the subject o f specific national, regional or intemational control programs to which the government subscribes.

9. The above screening process led to the selection o f the diseases indicated in Column 4 o f Table 1 below:

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Table 1 Summary of Recommendations for diseases and conditions to be included in the Integrated Disease Surveillance System (IDSS)

I’

Disease/Conditions DALYS‘ Mortality2 (000) Included in Core Method of Surveillance3 (000) ISDSS~

1. COMMkJNICABLE DISEASES A. VECTOR BORNE: Malaria 577 20 Yes A/P L 1 Dengue Fever 353 10 Yes L3 Japanese Encephalitis 66 1 Yes L3

Cholera NIA NIA Yes N P L

Polio 63 1 Yes AIP3 Diptheria 75 2 N o P L

HIVIAIDS 5,611 179 Yes Sentinel@,District/State

Hypertension N/A NIA Yes AP L l L 2 Diabetes Mell i tus 1,981 102 Yes AP L 1 L 2 Ischemic Heart Disease 1 1,697 1,47 1 Yes A/P L 1 L 2 Amenia in Premancv NIA NIA Yes AIP L 1 L 2

I .

Cataract 3,001 0 Yes AP L 1 L 2

Total Included in Core 73,647 3,3 94

Total for All India 268,953 9,337 IDSSS

Percent Total 27% 38% 4. WATER QUALITY

5. AIRQUALITY Yes Sentinel~DisnictiState

6. ANTI-MICROBIAL RESISTANCE

S 1 Based on WHO Burned o f Disease and Mortality Date for India 1998 2 Yes = Included in Integrated Disease Surveillance System

No = Included in at least one o f the Initial State’s State Level Surveillance System 3 A = Active Reporting

P = Passive Reporting L 1 =Laboratory Support at PHC Level L2 = Laboratory Support at Hospital Level L3 = Laboratory Support at Special Laboratory

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10. The following example illustrates how the criteria noted in paragraph 8 above were applied in some concrete cases:

Tuberculosis (TB): has a very high impact on the population as shown in Table 1 - 7.5 mill ion DALYs per year are lost because o f it. At the same t ime TB i s the subject o f specific, cost-effective interventions involving several international donors and has an established system o f surveillance already in place. Typhoid: while the disease burden due to typhoid i s not known with any accuracy, all States were unanimous that th is was a significant health problem with very significant epidemic potential and they believed it could be controlled more effectively if a good surveillance system was in place. The disease i s amenable to cost-effecive interventions and there i s good potential for action provided better information i s available. Ischemic heart disease (IHD): it i s evident from Table 1 that IHD i s the single most important disease burden for the population o f India - almost 12 mill ion DALYs are lost each year due to IHD. IHD has not been the subject o f surveillance before, but it i s clear that if effective control programs are to be designed, information on the prevalence o f risk factors i s needed on a regular basis; this information can be collected very cheaply once a surveillance system i s set up. Given the stage o f the epidemic o f IHD in India, information collected has a very high probability o f leading to significant public health action.

1 1. For the environmental conditions under surveillance, IDSP has not yet established protocols for direct l i n k s between data and action. These data are being collected to increase understanding o f the prevalence o f pollution and accidents, which to date have not been much addressed by India's public health and related sectors (with the exception o f water quality). Ultimately, it i s expected that the data will be used to formulate cross-sectoral strategies to enhance the protection o f public health.

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Annex 5: Financial Summary INDIA: Integrated Disease Surveillance Project

Years Ending

I Year1 I Year2 I Year3 I Year4 I Year5 I Year6 I Year7 Total Financing Required Project Costs Investment Costs 12.9 16.4 17.0 10.4 6.8 0.0 0.0

Recurrent Costs 4.0 4.5 5.0 5.6 6.0 0.0 0.0 Total Project Costs 16.9 20.9 22.0 16.0 12.8 0.0 0.0 Total Financing 16.9 20.9 22.0 16.0 12.8 0.0 0.0

Financing IBRDllDA Government

Central Provincial

Co-financiers User FeeslBeneficiaries Other Total Project Financing

13.3 3.6 2.8 0.8 0.0 0.0 0.0

16.9

17.9 3.0 2.1 0.9 0.0 0.0 0.0

20.9

18.3 3.7 2.2 1.5 0.0 0.0 0.0

22.0

11.4 4.6 2.4 2.2 0.0 0.0 0.0

16.0

7.1 5.7 2.7 3.0 0.0 0.0 0.0

12.8

0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Main assumptions:

1. Based on the World Bank Country Director's Office Memorandum o f April 08,2004 entitled "India: Exchange Rates and Price Contingencies for Project Analysis", the following exchange rates have been used: Year 1 (US$l=Rs.45), Year 2 (US$l=Rs.45.2), Year 3 (US$l=Rs.46), Year 4 (US$1=46.9); and Year 5 (US$1=47.9)

2. GO1 has decided that the State Governments would have to meet part o f the incremental operating cost starting at 20% in year one and taking over the entire recurring cost after closure o f the project. Therefore, State Government shares would be: 20% for year 1,20% for year 2, 30% for year 3,40% for year 4, 50% for year 5 and 100% recurrent cost after closure o f the project.

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Annex 6(A): Procurement Arrangements INDIA: Integrated Disease Surveillance Project

Procurement

The procurement arrangements to be undertaken in the project will be the responsibility mainly o f the implementing agency - Project Coordination Unit in the Ministry o f Health and Family Welfare, Government o f India, N e w Delhi in accordance with the Bank ProcurementKonsultancy Guidelines and procedures. There i s a Joint Secretary in MOHFW in-charge o f all activities o f the project. There i s a procurement consultant recently appointed by MOHFW to take care o f the procurement issues under this project. The project would be a Central Sector Project implemented nationwide. Diagnosis o f target diseases, assessment o f emerging situation through use o f information and technology and rapid response to prevent and control target diseases are the key activities o f this project.

The project i s proposed to be implemented in three phases in the f irst three years (2004-05, 2005-06, and 2006-07) to ensure effective implementation o f the project throughout the Union o f India in all 592 districts o f the States. A total o f 3,356 Peripheral Laboratories at Community Health Centers (1,634 laboratories in Year 1; 989 laboratories in Year 2 and 733 laboratories in Year 3), 592 District Laboratories and 592 Surveillance un i t s (206 in Year 1; 176 in Year 2 and 210 in Year 3); 3 1 State Laboratories and 31 Surveillance Units (9 in Year 1; 13 in Year 2 and 9 in Year 3) and 1 Central Laboratory and 1 Central Surveillance Units (both in Year 1) are covered under the project.

Procurement o f works and small value items will be done by the Districts & State Laboratories and Surveillance Units. Major Procurement o f Works, Goods and Services (big ticket items) and procurement o f some o f the small items required for the Central Labs and Surveillance Units would be done at Central level through a procurement agent to be appointed under the project. The procurement agent will be selected following competitive process o f Quality and Cost Based Selection (QCBS) o f the World Bank’s Consultancy Guidelines.

Phase I would cover nine States and these are Andhra Pradesh, Himachal Pradesh, Kamataka, Kerala, Madhya Pradesh, Maharashtra, Mizoram, Tamil Nadu, and Uttaranchal. (Total number o f districts in all the nine states - 206).

Phase I1 would cover thirteen States and 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 I11 would also cover thirteen States and 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 o f districts in all the thirteen states - 210).

Procurement o f Civil works, goods and services as well as that under incremental operating cost i s discussed below in detail.

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A. Civil Works (US $5.33 million)

There i s no new construction under the project. Only renovation, repair o f existing structures or extension o f facilities are envisaged in the project. The works are scattered all over India and these will be carried out in phases in the f i rst three years o f the project. Civ i l works at peripheral level will be undertaken by direct contracting as value o f each work i s very small and these are widely scattered. Civ i l works at the district and central level will be carried out following national shopping procedures. In all there will be 4604 packages (total estimated cost: U S $5.33 mill ion equivalent) in the range o f U S $445 to U S $22,220 equivalent.

B. Goods

Procurement o f Goods (laboratory equipment, office equipment, computer hardware, application and system software, furniture/fixtures and materials & supplies) would be phased on an annual basis to synchronize with the project activities.

(i) Laboratory Equipment (US $14.02 million)

Ten (10) items o f laboratory equipment are to be procured at peripheral level and twenty (200 items at district/state/central level. These items include Binocular microscopes, table top centrifuge, refrigerator, deep freezer, incubator, autoclave, ELISA reader etc. Quantity o f each item required by various laboratories will be worked out by the project authorities after assessing the availability o f existing equipment at these laboratories by undertaking facility survey which already underway. However, average expenditure incurred will be U S $90 at each peripheral laboratory, U S $8,890 at each district laboratory o f minor States, U S $18,890 at each district laboratory o f major States, U S $8,890 at each State laboratory and U S $44,450 equivalent at each Central Laboratory.

Binocular Microscopes, autoclaves, hot air ovens and bio-safety hoods will be procured by procurement agent at Central level under International Competitive Bidding (ICB). Other equipment estimated to cost U S $2,220 or more each will be procured following National Competitive Bidding (NCB) procedures. Minor equipment estimated to cost less than US $220 approximately each will be procured under National Shopping (NS) procedures by the District and State laboratories. Total number o f packages are 12 I C B (total estimated cost: U S $6.19 mill ion equivalent) in the range o f U S $0.67 mill ion to U S $1.33 million, 9 N C B (total estimated cost: US$ 1.04 mill ion equivalent) in the range o f U S $0.22 mill ion to U S $0.3 1 mill ion and 624 N S packages (total estimated cost: U S $6.79 mill ion equivalent) in the range o f U S $2,220 to U S $17,780 equivalent.

(ii) Computer Hardware and Operating System (US $9.96 million)

Connecting peripheral, district, state and central surveillance un i t s i s the major activity o f this project. Computer server, router, modem, printer, U P S , etc. are required to be procured for networking. Total estimated value o f the procurement i s U S $9.96 million. Since all activities under the project would be covered in three phases, computer hardware would also be procured in three phases under separate I C B packages, one each estimated cost U S $3.47 million, U S $3.07 mill ion and U S $3.42 mill ion equivalent for year 1, year 2 and year 3 respectively.

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(iii) Office Equipment (US $2.26 million)

To implementation o f the project a l l surveillance uni ts (peripheral/district/state/central) are to be equipped with office equipment such as photocopier, fax machine, overhead projector, L C D projector, air conditioner and telephones etc. These items will be procured individually as these are not manufactured by the same manufacturer. DistrictdStates will procure air conditioners and telephones adopting national shopping procedures. Other items will be procured under N C B procedures.

Total estimated cost o f th is component would be US $2.26 mill ion equivalent. There will be total 1273 packages consisting o f 13 N C B packages (estimated cost - US$1.10 million) in the range o f U S $44,445 to U S $2444,445 and 1260 NS packages (estimated cost - U S $1.16 million) in the range o f US $1,110 to U S $2,220.

(iv) Operating System for Server, RDBMS, Website Tool and GIS Software (US $4.42 million)

Operating system i s required for carrying out various functions (data entry, data analysis, transmission o f information and reporting) o f networking the computers. These are o f f the shelf available items and will be procured centrally under ICB procedures. Total estimated cost o f this component i s U S $4.42 mill ion equivalent. There will be three I C B packages, one for each phase o f the project at an estimated cost o f U S $1.55 mill ion for phase 1 (year 1), U S $1.34 mill ion for phase 2 (year 2), and U S $1.53 mill ion equivalent for phase 3 (year 3) o f the project.

(v) Furniture and Fixtures (US $3.09 million)

Furniture and Fixtures which includes tables, chairs, laboratory platforms, washbasins etc. are required for laboratories and surveillance units. Nine (9) items o f furniture and fixtures are required for laboratories and seven (7) for surveillance units. Quantity o f each item required by the laboratories/surveillance units will be worked out by assessing the availability o f existing items in these laboratories but average expenditure to be incurred would be U S $220 for each peripheral laboratory and surveillance unit and U S $1,330 for each district and state laboratories and surveillance units. These items would be procured following National Shopping (NS) procedures at district, state and central level. Districts will also procure the requirements o f peripheral laboratories / surveillance units. Total number o f packages will be 625 (total estimated cost: U S $3.09 mill ion equivalent). There would be 217 packages in year 1 (estimated cost - U S $1.075 million), 189 packages in year 2 (estimated cost - U S $0.93 million), and 2 19 packages in year 3 (estimated cost - U S $1.085 million). Cost o f each package will not exceed U S $8,890 equivalent.

(vi) Material and Supplies (US $6.68 million)

Laboratory consumable goods and supplies would be required continuously for the purpose o f various diagnostic tests. These include slides, gloves, test tubes, cotton wool swabs, blood culture bottles, aluminium foil, typhoid rapid diagnostic lut, faecal contamination rapid test k i ts, HIV diagnostic kit ELISA etc. Maximum o f 15 items at peripheral laboratories, and 21 items at districthtate laboratories would be procured. Average expenditure for each laboratory would not exceed US $220 equivalent for peripheral, US $2220 for district, and U S $4,445 equivalent for state laboratory. Items l i ke HIV k i t s and rapid test kits will be procured through National Competitive Bidding at Central Level; and all other items will be procured through National

- 46 -

Shopping at the district and/or state level. Districts will also procure the requirements o f peripheral laboratories. Total estimated cost i s U S $6.68 mill ion equivalent with 15 N C B packages (total estimated cost: US $0.99 mill ion equivalent) in the range o f U S $2,220 to U S $1 1,110 and 2488 National Shopping (NS) packages (total estimated cost: U S $5.69 mill ion equivalent) in the range o f U S $3,330 to U S $6,670 equivalent.

C. Services

(i) Information, Education, and Communication {IEC} (US $7.74 million)

IEC activities includes organization o f sensitization workshops, review meetings, publication o f advertisement in newspapers to make the public aware about the preventive action to be taken against various diseases, printing o f leaflets/brochures/formats for reporting, street plays, puppet shows, counseling and motivation o f public through inter-personal communication. These activities will be carried out each year at district, state and national level at a total estimated cost o f U S $7.74 mill ion equivalent.

Sensitization workshops (estimated cost: U S $1.77 mill ion equivalent) and review meetings (estimated cost: U S $0.64 mill ion equivalent) will be organized by the surveillance units. Press advertisements for public awareness (estimated cost: U S $1.29 mill ion equivalent) at peripheral, district and state level will be arranged at least cost from three or more news papers. Printing o f pamphlets, brochures, manuals etc. (estimated cost: U S $1.3 1 mi l l ion equivalent) at peripheral, district and state level will be arranged by calling at least three quotations.

IEC activities at the national level l ike development and publication o f advertisements in national newspapers for public awareness, printing o f manuals, guidelines, training modules, production and telecasthroadcast o f TVRadio spots would be arranged through an agency to be hired following Quality and Cost Based Selection (QCBS) procedure. Estimated cost o f this activity i s U S $1.71 mi l l ion equivalent. Other media activities l ike street plays, puppet shows etc. w i l l be organized following direct contractinghingle source selection method (estimated cost: U S $1.02 mill ion equivalent).

(ii) Studies (US $1.17 million)

Quality Assurance o f laboratory services, survey on risk factors on non-communicable diseases, evaluation o f training activities at various levels, effectiveness o f information, technology and cost benefit analysis o f the project etc. wi l l be carried out during the initial stage, third year and in the final year o f the project. In all there would be 14 studies (Year I - 2 studies at an estimated cost o f U S $0.15 million; Year I1 - 2 studies at an estimated cost o f U S $0.14 million; Year I11 - 5 studies at an estimated cost o f U S $0.42 million; Year IV - 1 study at an estimated cost o f U S $0.12 million; and Year V - 5 studies at an estimated cost o f U S $0.34 mill ion

(iii) Training (US $4.42 million)

Training would be undertaken at various levels in the laboratories and surveillance units. A total o f 195,190 personnel would be trained at a total estimated cost o f U S $4.42 million. The training includes (i) training o f multi purpose health workers (MPW) and laboratory assistants (estimated cost: U S $2.79 million) to be undertaken in-house at selected community health centers, (ii) training o f medical officers o f primary and community health centers (estimated cost: U S $1.04

- 4 7 -

million) to be undertaken in-house at district surveillance units, and (iii) training o f laboratory technicians, data managers, district and state surveillance teams (estimated cost: US $0.59 million) to be organized in professional institutions selected under Quality Based Selection (QBS) at about 25 institutions to be selected for each type o f training and in all there will be 75 contracts each year.

(iv) Other Consultancy Services

Procurement o f goods, equipment, IT hardware and software and lab materials at the central level w i l l be carried out by a procurement agent to be appointed following QCBS procedure in Project Coordination Unit. Estimated fee to be paid to the consultant firm would be US $0.56 mill ion approximately.

A specific type o f software i s required to be developed for effective surveillance o f various diseases. For this an agency would be selected through Quality and Cost Based Selection (QCBS) which will not only develop the software but will also test, operate, train the client’s personnel and maintain the software. Total cost i s estimated to be US $1.68 million.

Wide Area Networking (WAN) will be required for connecting the computer systems o f the surveillance un i t s after the computer hardware has been procured and installed. WAN will be leased from the second year o f the project up to the fifth year o f the project and leasing company will be selected following the least cost method o f selection. Estimated cost o f leasing o f WAN would be US $1.21 mill ion for phase I, U S $0.84 mill ion for phase 11, and US $0.73 mill ion for phase I11 making a total o f US $2.78 million.

D. Miscellaneous (Incremental Operating Cost)

Th is involves operational expenses for all the components o f the project and would include office expenses, office stationery, travel costs and POL, hiring and maintenance o f vehicles, maintenance o f equipmendcomputers, salary o f incremental staff and consumables, and individual consultants hired for specialized services to serve in the district and state surveillance units.

Contracts for hirindmaintenance o f vehicles, and maintenance equipmendcomputers would be procured on the basis o f direct contracting or National Shopping (three quotations depending on the situation). Value o f each contract i s estimated below US$ 10,000 equivalent and total estimated cost o f such contracts would be US $12.47 mill ion equivalent (Year 1 - U S $4.0 million; Year 2 - US $2.43 million; Year 3 - U S $1.82 million; Year 4 - US $2.73 million; and Year 5 - US $1.49 mill ion equivalent).

Number o f personnel to be hired will be 4 for each district surveillance unit, 7 for each state surveillance unit and 15 for each central surveillance unit. In all there will be 10,399 annual contracts (902 in year 1 - estimated cost : US $1.09 million), 1697 in year 2 - estimated cost: US $1.97 million), and 2600 each in year 3,4 and 5 o f the project - estimated cost: US $3.0 mi l l ion each year) at a total estimated cost o f US $12.06 mill ion equivalent. Value o f each contract would be in the range o f US $800 to US $6,935 equivalent.

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E. Bidding Documents

Contracts for I C B and N C B will be awarded by the Procurement Support Agency while procurement under National ShoppingDirect Contracting will be done by the DistricUState Laboratories themselves.

Standard Bidding Documents, as finalized by the Government o f India Task Force and agreed with the Bank would be used for all I C B and N C B contracts. These are W-9, E-1, E-4, E-6 and E-7. Contracts for National Shopping i.e. by collecting quotations would be concluded based on the formats developed by New Delhi Office (NDO) Procurement Unit and approved by the Bank. These are E-5, W-5 and W-6.

Similarly, Request for Proposals (RFP) for consultancy services for different assignments which are based on Bank’s Standard RFP and available with N D O Procurement Unit o f the Bank shall be adopted. Formats o f letter o f agreements for short t e d o n g term assignments o f individual consultants as well as RFP for small assignments for f i r m s as per Bank’s New Delhi Office model documents shall be adopted. These are C-8 (Lump Sum), C-9, C-10, C-13, C-l3/PFC.

F. norms for such procurement i.e. procedure to be followed, range o f prices and acceptable/preferable brand names etc. shall be clearly indicated in the guidelines to the laboratories so that these are followed while procuring these items. The auditors appointed under the project, apart from the usual financial aspects, should also audit the procurement and comment whether stipulated national shopping procedures were followed.

For the items to be procured under national shopping procedures andor direct contracting, the

G. o f works/ gooddequipment and consultancy services, details o f value o f works/goods/equipment/consultancy services for each year o f the project and procurement schedules o f works/goods/equipment and consultancy services for all the five years o f the project are attached with the Project Implementation Plan (PIP) o f the borrower (MOHFW). H. Post Award Review

Cost estimates o f the c iv i l works, items to be procured, estimates o f bid packages for procurement

Because o f the nature o f this operation, a large number o f contracts would be below prior review limits. I t i s expected that the project will have about 20,000 contracts over a five year period. Except a few contracts, all other contracts will be in the range o f US $400 to $ 30,000. The project i t se l f provides for a se l f audit to be conducted by independent auditors hired by the Borrower for expenditures as well as procurement reviews for contracts under national shopping procedures. The normal Bank’s requirement o f ex-post review o f 1 in 5 contracts for a high risk project, can not be achieved in this project due to resource constraints, since annual budget allocations only allow for a total o f roughly 1,000 ex-post contract reviews for the entire India Portfolio. Given the sheer numbers o f contracts envisioned in this project, the Bank’s resource constraints, the mitigating effect o f the self audit and technical audits mentioned above, we would consider the “benchmark“ review level o f 1 in 5 contracts to be excessively large for th is type o f operation. In addition to a review o f reports o f independent auditors called for in this project, Bank staf f will also conduct post award reviews during supervision missions. These reviews will be periodically supplemented by an appropriate allocation o f random ex-post reviews conducted by f i rms engaged by the Region for post award review coverage on the India portfolio as a whole.

Procurement methods (Table A)

IDA Financed Works and Goods will be procured in accordance with Bank Guidelines - Procurement

- 4 9 -

under IBRD Loans and IDA credits [January 1995, revised January and August 1996, September 1997 and January 19991. IDA Financed services will be procured using Bank Guidelines - Selection and Employment o f Consultants by World Bank Borrowers (January 1997, revised September 1997, January 1999 and May 2002). Attachment 1 to this Annex summarizes the procedures for undertaking procurement on the basis o f National Competitive Bidding (NCB).

Specific Procurement Arrangements summarized in Table ‘A’ are as follows:

0

0

0

0

Each contract for works valued U S $30,000 equivalent or less may be procured through direct contracting or national shopping or force account. Each contract for works valued more than U S $30,000 equivalent may be procured through National Competitive Bidding. Contracts for the procurement o f gooddequipment valued more than U S $500,000 equivalent each may be procured through International Competitive Bidding (ICB). Contracts for the procurement o f gooddequipment valued more than U S $30,000 equivalent but less than U S $500,000 may be awarded on the basis o f N C B procedures acceptable to IDA.

Items or groups o f items valued U S $30,000 equivalent or less per contract may be procured on the basis of National Shopping procedures.

Other items or small groups o f items such as furniture, equipment, materials and other supplies valued at less than U S $30,000 equivalent per contract may be procured through direct contracting.

Contracts estimated to cost an equivalent o f U S $10,000 or less per contract for maintenance o f computers/equipment/vehicles, hiring o f vehicles and office consumables may be awarded through:

0

Direct Contracting; or National Shopping

Table A: Project Costs by Procurement Arrangements (US$ million equivalent)

Figures in parentheses are the amounts to be financed by the IDA Credit. All costs include contingencies.

Includes c iv i l works to be procured by calling at least three quotations and goods to be procured through national shopping, consulting services, services o f contracted staff o f the project management office, training, technical assistance services, and incremental operating costs related to (i) managing the project and (ii) re-lending project funds to local government units.

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Table A I : Consultant Selection Arrangements (optional) (US$ million equivalent)

A. Firms

B. Individuals

Total

6.43 0.59 0.00 4.08 0.00 7.25 0.00 18.35 (5.79) (0.59) (0.00) (3.67) (0.00) (6.91) (0.00) (16.96) 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

(0.00) (0.00) (0.00) (0.00) (0.00) (0.00) (0.00) (0.00) 6.43 0.59 0.00 4.08 0.00 7.25 0.00 18.35

(5.79) (0.59) (0.00) (3.67) (0.00) (6.91) (0.00) (16.96) I\

Including contingencies

Note: QCBS = Quality- and Cost-Based Selection QBS = Quality-based Selection SFB = Selection under a Fixed Budget LCS = Least-Cost Selection CQ = Selection Based on Consultants' Qualifications Other = Selection of individual consultants (per Section V of Consultants Guidelines), Commercial Practices, etc. N.B.F. = Not Bank-financed Figures in parentheses are the amounts to be financed by the Bank Credit.

Prior Review Thresholds (Table B):

All contracts for works with an estimated value o f more than U S $500,000 equivalent. Contracts for gooddequipment estimated to cost the equivalent o f U S $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 o f the initiation o f the process for the procurement of goods/equipment; and (B) provide to the Association for i t s approval, any proposed changes to the bid documents from the earlier contract relating to the method o f procurement, specifications, and qualifications and evaluation criteria. The f i rs t N C B contract for goods valued more than U S $30,000 but less than U S $500,000 equivalent. Consultant's contracts with an estimated value o f U S $100,000 equivalent or more for f i r m s and US $50,000 equivalent or more for individuals, provided, however, subsequent contracts for the employment o f consulting f irms or individuals for the same type o f 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 o f the initiation o f the process for the selection of consultants; and (B) provide to the Association for i ts approval any proposed changes to the terms o f reference, qualifications and experience o f the consultants.

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Table B: Thresholds for Procurement Methods and PriorPost Review

Expenditure Category

1. Works Civ i l Works

:. Goods .aboratory/Office iquipment, :umiture, Reference ltandards, and daterials & lumlies

I. Services 'rofessional ;ervices, :onsultancy

Contract Value Threshold (US $1

Civil Works estimated to cost the equivalent o f US$ 30,000 or less per contract may be executed bv: (i) direct contracting; or (ii) on the basis o f comparison o f price quotations obtained from at least three qualified contractors eligible under the guidelines: or (iii) by Force Account as a last resort in a manner satisfactory to the association. Xvil Works estimated to cost l e equivalent o f more than JS$30,000 per contract

JS$30,000 or less per contract

JS$500,000 or less per contract ut more than US$ 30,000 quivalent

dore than US$500,000 quivalent per contract

,hove US$200,000 equivalent er contract

Procurement Method

Direct Contracting Solicitation o f three bids

Force Account

qational Competitive 3idding (NCB)

Vational Shopping NS) Procedures or IGS&D Rate Contract

qational Competitive 3idding (NCB)

ntemational Zompetitive Bidding ICB)

2uality & Cost Based Selection

Contracts Subject to Prior I Post review (US $ millions)

Post review only Post review only

Post review only

%or review o f f i rst contrac below US$SOO,OOO but .bove US$30,000 and al l :ontracts above JS$500,000. Jalue o f prior review: rl I L. I11 others bv Dost review.

'ost review only

'rior review o f first contrac )elow US$500,000 but ibove US$30,000. All Ithers by post review.

Jalue o f Prior Review: JS$0.08 mi l l ion 'rior review for a l l contracl )f first year o f the project :osting more than JS$500,000 each. Total ralue o f prior review US$ 5.16 mi l l i on

'rior review o f two :ontracts valued at US$2.24 n i l l i on

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ervices and IEC ervices 'raining & iorkshops, IEC mices, Studies, :ontractual services nd other onsultancy services

'raining & dorkshops, IEC ervices, Studies, !ontractual Services nd other onsultancy services

US$200,000 equivalent or less per contract

QCBS method o f selection with short l i s t above US$lOO,OOO (may be comprised entirely o f national consultants) for individuals.

Prior review o f a l l contracts

equivalent for f i r m s and above US$50,000 equivalen

Prior review o f three contracts valued at US$0.45 mi l l ion

US$lOO,OOO equivalent or less (i) QCBS method o f Prior review above per contract for firms and US selection with short l i s t US$lOO,OOO equivalent for $50,000 equivalent and less per (may be comprised firms and above US$50,000 contract for individuals entirely o f national equivalent for Individuals.

. Miscellaneous I

consultants)

(ii) Consultant's Qualifications as per

Post review only Post review only Post review only

v i l u e o f Prior review NIL.

Other contracts - Post review only

Total value o f contract subject to prior review: US$ 8.85 million

perating costs

Overall Procurement Risk Assessment: Average risk

- vehicles, maintenance o f (ii) on the basis o f - computerdequipment, and comparison o f price consumables estimated to cost quotations obtained the equivalent o f US$lO,OOO or from at least three less per contract may be awardedqualified suppliers by: eligible under the

guidelines; or (iii) Force Account as a last resort

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Frequency of procurement supervision missions proposed: Every 6 months along with joint supervision mission (includes special procurement supervision for post-review o f contracts. Frequency o f procurement supervision i s subject to increase, if need arises.).

ATTACHMENT - 1

IDA Financed Works and Goods will be procured in accordance with Bank Guidelines - Procurement under IBRD Loans and IDA credits [January 1995, revised January and August 1996, September 1997 and January 19991. IDA Financed services will be procured using Bank Guidelines - Selection and Employment o f Consultants by World Bank Borrowers (January 1997, revised September 1997, January 1999 and May 2002). All National Competitive Bidding (NCB) contracts to be financed from the credit under the project would follow procedures satisfactory to the IDA, which are:-

1.

2.

3.

4.

5.

6.

7 .

Only the model bidding documents for NCB agreed with the Government o f India Task Force [and as amended from time to time], shall be used for bidding. Invitations to bid shall be advertised in at least one widely circulated national daily newspaper, at least 30 days prior to the deadline for the submission o f bids. N o special preference will be accorded to any bidder when competing with foreign bidders, state-owned enterprises, small-scale enterprises or enterprises from any given State. Except with the prior concurrence o f the Bank/Association, there shall be no negotiation o f price with the bidders, even with the lowest evaluated bidder. Except in cases o f force majeure and/or situations beyond control o f Ministry o f Health & Family Welfare, extension o f bid validity shall not be allowed without the prior concurrence o f the BanWAssociation (i) for the f i rst request for extension if it i s longer than eight weeks; and (ii) for all subsequent requests for extension irrespective o f the period. Re-bidding shall not be carried out without the prior concurrence o f the BankJAssociation. The system o f rejecting bids outside a predetennined margin or " bracket " o f prices shall not be used. Rate contracts entered into by DGS&D will not be acceptable as a substitute for N C B procedures. Such contracts w i l l be acceptable for any procurement under National Shopping procedures.

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Annex 6(B): Financial Management and Disbursement Arrangements INDIA: Integrated Disease Surveillance Project

Financial Management

1. Summary o f the Financial Management Assessment The project has a financial management system, which would be able to adequately account and report the project resources and expenditures.

Country Specific Issues

Generic country level issues and specific resolutions under the project are discussed further. 0 GOI’s existing accounting system concentrates mainly on book keeping and transactional control

over expenditures. A separate project financial management system has been designed for the project to address this issue which wi l l enable generation of reliable financial reports for enabling timely managerial decision making. Quality and timeliness o f audit reports: as the audit o f Central Surveillance Unit (CSU) w i l l be conducted by Controller and Auditor General (C&AG), India for the expenditure incurred by the CSU, it has been agreed with the MOHFW and C&AG’s oflce that the projectfinancial statements generated by the project for the expenditure incurred at the CSU would be audited in accordance with TORS agreed with the Bank and consented to by the C& AG’s office.

0

The audit of the state societies at the state and the districts would be carried out by independent chartered accountants firms and one consolidated report for each state w i l l be received.

The following country issue with respect to non-availability o f the project financial statements does not

(a) The state and the district society will be required to prepare financial statements which will be audited by an independent chartered accountants firm. The CSU will also maintain independent books based on which a set o f sources and applications o f funds will be prepared for the expenses incurred at the CSU. (b) The issue o f availability o f funds on a timely basis to the project implementing entity i s not a major concern as the funds from GO1 would be remitted directly to an identified state-level society and the project states are meeting only a small part (around 10%) o f the total cost.

apply:

Strengths and Weaknesses

Strengths

The project has the following strengths in the area o f financial management:

0 A project finance manual has been prepared which details the accounting policies, procedures and processes, operation o f the project financial management system, reporting arrangements.

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Significant weaknesses

Significant weaknesses An existing accounting system which primarily focuses on book keeping, and not on financial management.

In centrally sponsored projects the flow o f funds from the center to the states and the district i s not normally linked to meeting financial reporting targets (i.e timely submission o f Statement o f Expenditures (SOE), Financial Management Reports and audit reports).

Mitigation A simple Financial Management System based on manual books o f account has been developed. This i s in l ine with the sk i l l / capacity at the district level. A Finance manual has also been developed for the project, which focuses on financial reporting and monitoring. It has been agreed and included in the Finance Manual that f low o f fbnds will be linked to adherence to financial reporting conditions.

Finance Staffing and Training

The Director or Deputy Secretary in the Finance Division o f the MOHFW would overlook the financial matters o f the project. H e would be assisted by one qualified finance professional, designated as Finance Manager for the project and one other finance professional who i s experienced in government accounting procedures. They would be responsible for establishment o f 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 o f funds and providing overall guidance in respect o f the financial management issues for the project. The other members o f the finance team would include two junior level accountants & and other support level s taf f as required under the project.

At the state level a State Accountant (Finance Consultant) will be hired on a competitive basis and shall meet the minimum s k i l l set acceptable to IDA. The accountant at the district level w i l l be from the existing society. A training plan, which i s detailed in the Project Implementing Plan (PIP), has been drawn up which aims at providing sufficient training to the finance staff in the proposed Financial Management System, disbursement policies and procedures and the financial reporting requirements.

Fund Flow Arrangement

Annual allocations to each State would be released in two installments during the 1 st and 3rd quarters o f each Fiscal Year. Funds required to implement the Project will be released through the identified State Health and Family Welfare SocietyJdisease specific State Society to ensure effective and efficient implementation o f the Project. The State level society would release necessary funds to District level society usually twice a year. Amount o f installment would depend upon requirement and utilization o f funds released earlier. The funds flow to the various levels will be as under:

a. Central level

The funds at the central level would be made available to the l ine ministry (MOHFW) through the Union budget (after project effectiveness) and the annual budget would be based o n the annual work program at

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the CSU and the requirements o f the participating states in respect o f their specific annual work plans. The initial allocation for States will be based on their cash flow forecasts (which in turn would be based on their work programs and budgets). Subsequent funding wi l l also take into consideration state performance and the projected funds requirement for the next period and the unspent cash balances, if any, and the state's contribution towards the Incremental Opearting Costs.

b. State level

Under the umbrella o f the identified State Level Society, a separate bank account in the name o f "State Surveillance Unit (name o f State)" would be opened in a Nationalized Bank. Funds would be released by the Central Surveillance Unit directly to the state society by a chequeldemand draft. The State Surveillance Unit (SSU) would release funds to District Surveillance Units (Name o f District) and other organizationslagencies, also by chequeldemand draft. All the 9 States in Phase I o f the project have already identified and confirmed the society which would be responsible for the funds flow, accounting, reporting and audit o f the project expenditure and have also completed a State Financial Management Checklist.

c. District level

The District Surveillance Units will receive funds by cheque/demand draft from the SSU and a separate bank in the name o f "District Surveillance Unit" would be operated under the umbrella o f the existing District level Societies identified by the states. Funds for the purpose o f activities envisaged at the primary health center and Community Health Center (CHC) level would also be released by the district society as an advance for training and other activities and accounts settled. Transaction vouchers would be maintained for all receipts and expenditure by the District Surveillance Unit. Release o f funds from the central to the state level, and state to the district level would be incumbent on the receipt o f the audit certificates and Utilization Certificates. No fiuther release o f funds would be affected to the concemed units from central/ state level in case audit certificates and Utilization Certificates are not received in time.

Budgeting

The funding to the Integrated Disease Surveillance Project would be through the budget o f the Ministry o f Health and Family Welfare. A separate budget head and related provision would also be created at the State level for their share of Incremantal Operating Costs. Annual budget o f 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 o f funds released. Funds provided by the Center to the States, would be on a full grant basis.

Books of accounts and Accounting Policies and Procedures

The project costs incurred at the CSU and those incurred by the Central Procurement Agent would be recorded in the books o f the CSU 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 GO1 are captured in the various accounting forms ('Books o f Forms'), cash book, the reports, the public works account code, the Central Public Works Department (CPWD) manual and General Financial Rules (GFR) as issued from time to time. These policies and procedures are exhaustive and capture the requirements o f the Auditor General, Department o f Finance and other stakeholders requiring financial information. These guidelines also lay down the intemal control procedures and the formats o f the reports and books o f accounts. In spite o f a wel l established system o f accounting and reporting the expenditures, this system, however, has no established method for capturing physical information and integrating/ linking

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it with the financial information.

A Financial Management System (FMS), for the project, based on a manual system (with support by way o f excel spreadsheets) has been designed to accurately record and timely report the project expenditures at the aggregate project level. Expenses would be recorded on a cash basis and would follow broadly the project components and activities for ease in reporting to various stakeholders.

Standard books o f accounts on a double entry basis (cash and bank books, journals, fixed assets register, ledgers, work registers, contractor registers etc.) w i l l be maintained under the project by the CSU and the state and district societies. A finance manual laying down the financial policies and procedures, periodic & annual reporting formats including financial statements, f low o f information and methodology o f compilation, budgeting & flow o f funds, format o f books o f accounts, chart o f accounts, information systems, disbursement arrangements, internal control mechanisms, external audit for the project and operation o f the Financial Management System (FMS) has been prepared for guiding the project personnel.

Information Systems

Only manual books o f account are proposed for the project in view o f the relatively lower levels o f capacity at the district level and varying s k i l l sets from state to state. Procurement information indicating projects’ progress on various activities/components would be captured in pre-designed format on a manual basis. States would be required to report in pre-designed excel sheets for ease in comparison. CSU will consolidate the Financial & Procurement progress for preparing Financial Monitoring Report (FMR) and submit to IDA on a six monthly basis.The Physical progress reporting would be submitted during the joint review missions and based on specific focus o f the missions.

Reporting and Monitoring

Financial reporting (SOE, FMR’s and other financial/procurement progress related reports as specified in the Finance Manual) from implementing agencies at the State level to the CSU will be on a quarterly basis (for SOE’s) and six monthly (for FMR’s). The CSU will consolidate the quarterly claims and send it to CAA&A in DEA

The FMR formats are a part o f the Finance Manual. CSU will prepare the FMR’s (on cash basis) in the prescribed format for the project on a six monthly basis after consolidating the information received from the participating state level implementing agencies and forward it to the Bank within 45 days o f the end o f the six month period. In view o f the large number o f accounting un i t s (590 eventually) s i x monthly reporting on the FMR i s more realistic. FMRs will be used for disbursement on a mutually agreed time schedule after the project has demonstrated the capability o f producing consistent, timely and accurate FMRs.

FMR’s would meet the information needs and requirements o f MOHFW, IDA, and the project management.

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Impact of Procurement Arrangements

Implementing Agency CSU, MOHFW (1 audit report)

The procurements by the procurement agent at the center will be restricted to purchase o f computer hardware and software and contracts for ICB and N C B while procurement under National Shoppinflirect Contracting will be done by the District/State Laboratories themselves.

Audit Auditors SOE/Project Comptroller & Auditor General o f

2. Audit Arrangements

State level Implementing Agencies (35 audit reports) D E N G O I

External Audit

Audit India SOEProject Audit Special Account India

Consolidated audit report for each state from an independent auditor Comptroller & Auditor General o f

T h i s i s the f irst IDA assisted project to be implemented by the Central Surveillance Unit (within MOHFW) at Central Government. Under the proposed audit arrangement the project would be required to submit the following sets o f (9 in phase I, going up to 36 in phase 111) annual audit reports to the Bank, (i) an audit report in respect o f central CSU at MOHFW (including project financial statement- sources and uses o f funds) audited by C&AG, who shall be acceptable to IDA as an independent auditor, under terms o f reference agreed with IDA and;

(ii) One consolidated audit report (including project financial statement) for each state. T h i s consolidation at the state level will be based on the individual audit reports received from the district societies. The audit will be carried out in line with the terms o f reference (both for the stand alone audit o f the district and state society and the consolidation) approved by IDA.

I t has been agreed that one auditor will be appointed for each state who will have the responsibility for the audit o f the state society and all the district societies in a state and also the consolidation o f all the individual audit reports. This will serve the purpose o f achieving uniformity and consistency in the format o f financial statements and audit opinion. In larger states, joint auditors will be appointed. The appointed auditor will be allowed to contract out the work to other local audit f m s but will have the responsibility for the quality and timely submission o f the audit report.

In addition, an audit report for special account held at GO1 would also be submitted in usual the manner. The annual project financial statement to World Bank would include: (i) a summary o f funds received (showing funds received from the IDA, and a Summary o f expenditures shown under the main project components/ activities and by main categories o f expenditures); and (b) a Balance Sheet showing accumulated funds o f the Project, bank balances, other assets o f the project, and liabilities, if any (only in case o f the state & district societies). The audit o f the project accounts would also include an assessment o f (a) the adequacy o f the accounting and internal control systems, (b) the ability to maintain adequate documentation for transactions and (c) the eligibility o f incurred expenditures for Bank financing. The annual project financial statements duly audited would be submitted within 6 months o f the close o f GOI’s fiscal year. Thus the following audit reports will be monitored in Audit Reports Compliance System (ARCS):

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Internal Audit

As the project i s widely spread (being implemented in all the 590 districts o f the country) it will not be possible to have a meaningful and comprehensive internal audit. T h i s i s sought to be mitigated by means o f developing a checklist against which six monthly review would be conducted by the state society accountant and also by supervision teams from the CSU and the IDA. This checklist would be made an integral part o f the finance manual and included in the TOR (job responsibilities o f the state accountant).

3. Disbursement Arrangements

GO1 would open a special account with the Reserve Bank o f India to receive the disbursements under the project from the Bank. Disbursements from the IDA credit would initially be made in the traditional system (reimbursement with full documentation and against statement o f expenditure) and could be converted to the Financial Management Report (FMR) based disbursement at the option o f GO1 and the participating States after the project successfully demonstrating capacity to generate quality FMRs.

A Special Account would be maintained in the Reserve Bank o f India; and would be operated by the Department o f Economic Affairs (DEA) o f Government o f India (GOI). The authorized allocation o f the Special Account would be US$ 13.6 mill ion that represent about 4 months o f initial estimated disbursements 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 o f Aid, Accounts and Audit (CAA&A) in DEA for onward submission to the Bank for replenishment o f the special account or reimbursement.

Use of Statement of Expenditure (SOE) : Disbursement will be made on the basis o f statement o f expenditure for (a) c iv i l works for contracts not exceeding US$ 500,000; (b) Goods for contracts not exceeding US $500,000; (c) consultants for contracts not exceeding US$lOO,OOO for f i r m s and US$ 50,000 for individuals and for (d) training, workshops, studies and incremental operating costs.

Retroactive Financing: Retroactive financing will be provided for project preparation and project expenditures amounting to approximately $2.00 mill ion for expenditures incurred after April 1,2003. The following activities would be eligible for retroactive financing - workshops, pilot testing o f manuals, pilots for involvement o f 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. Allocation of credit proceeds (Table C)

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Table C: Allocation of Credit Proceeds

Expenditure Category :1) Works :2) Goods

:3) (a) Consultants' services (other than services provided by tax-exempt providers)

(b) Consultant's services provided by ;ax-exempt providers, training and Norkshops [ncremental Operating Costs

(a) Phase I Project States:

@)Phase I1 Project States:

(c) Phase I11 Project States:

4.00 30.82

5.84

7.29

13.25

Unallocated

rota1 Project Costs with Bank 68.00

rota1 68.00

90% 100% o f foreign expenditures, 100% o f local expenditures (ex-factory cost) and 30% o f local expenditures for other items

Drocured locallv 90%

100%

80% for year 1 and Year 2; 70% for year 3; 60% for year 4;and

50% for year 5

80% for year 2; 80% for year 3; 70% for year 4;and

60% for year 5

80% for Year 3 and 4 70% for Year 5

Financial covenants:Besides the usual conditions o f audit, FMR's etc., following will be required: (i) qualified finance consultant at the CSU having qualification and experience satisfactory to the Association no later than 30 days after the Effective Date; and ensure that this positions remain fi l led throughout the l ife o f the Project. (ii) 1 States having qualification and experience satisfactory to the Association no later than 30 days after the Effective Date; and in Phase I1 and Phase I11 states upon their entry into the Project and ensure that this positions remain filled throughout the implementation o f the Project.

the Borrower shall appoint in accordance with TORS satisfactory to the Association (IDA) a

the Borrower shall ensure that State-level Financial Consultants are appointed in each o f the Phase

Supervision Plan The project would require an in-depth supervision in the initial year especially for ensuring successful implementation o f the state level FM and fund flow arrangements. Mid term review would be conducted after two and a half years o f the project to comprehensively review the FM performance o f the project.

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Annex 7: Project Processing Schedule INDIA Integrated Disease Surveillance Project

Project Schedule Planned Actual ITime taken to prepare the project (months) I I 16 I

Negotiations

Planned Date of Effectiveness

/First Bank mission (identification) I 11/21/2001 I 11/21/2001 I

04/26/2004 0511 112004 09/30/2004

/Appraisal mission departure I 03 12012 00 3 I 04/28/2003 I

IMam Chand I Senior Procurement Specialist I

Prepared by: Ministry o f Health and Family Welfare, Government o f India.

Name Peter Heywood Rashmi Sharma K. Sudhakar Nira Singh

Preparation assistance: USAID and WHO provided support for workshops and preparation o f selected project preparation documents.

Speciality Lead Health Specialist and Task Team Leader Social Development Specialist Senior Health Specialist Program Assistant

Ian Morris Senior Human Resources Specialist / Economist

Mohan Gopalakrishnan Hugo Diaz-Etchevehere Varalakshmi Vemuru Ruma Tavorath Rachel Beth K a u h a n n Laura Kiang Elfreda Vincent Syed Ahmed Shellka Arora Mohammed Khalid Khan

Senior Financial Management Specialist Lead Operations Officer / Economist Senior Social Development Specialist Environment Specialist Senior Public Health Specialist Operations Officer Program Assistant Senior Counsel Legal Assistant Program Assistant

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Annex 8: Documents in the Project File* INDIA: Integrated Disease Surveillance Project

A. Project Implementation Plan

National level Project Implementation Plan (NPIP), Ministry o f Health and Family Welfare, India

Stateproject Implementation Plans for the States o f Andhra Pradesh, Himachal Pradesh, Madhya Pradesh, Maharashtra, Karnataka, Mizoram, Tamil Nadu, Uttaranchal and Kerala.

B. Bank Staff Assessments

1. Environmental Review o f the Health Sector portfolio in the South Asia Region. 2. Laboratory Assessment, US Center for Disease Control. 3, Training Needs Assessment in Tamil Nadu 4. Information Technology Assessment. 5. Strengths and Weaknesses o f existing community based disease surveillance programs in India. 6. Training strategy and Training Plan. 7. Models in Community Monitoring in India

C. Other

1. 2. 3. 4. 5. *Including electronic files

Operations Manual for District Surveillance Officers Operations Manuals for Medical Officers Operations Manuals for Para-medical Workers Operations Manuals for Laboratory Personnel National Health Policy - 2002, Government o f India

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Annex 9: Statement of Loans and Credits INDIA: Integrated Disease Surveillance Project

07-June-2004 Difference between expected

and actual disbursements' Original Amount in US$ Millions

Project ID FY Purpose IBRD IDA GEF Cancel. Undisb. Orig Frm Rev'd _____ P 0 7 8 5 5 0

PO55459 P 0 5 0 6 5 5 PO73776 PO73369 PO55459 PO79865 PO82510 PO71272 PO72123 P 0 6 7 6 0 6 PO50649 PO76467 PO75056 PO73094 P 0 5 0 6 4 7 PO40610 P 0 5 0 6 6 8 PO72539 PO50653 PO69889 PO71033 PO74018 PO55454 PO50658 PO71244 PO70421 PO67543 PO67216 PO38334 PO59242 PO55455 PO35173 PO 10566 PO45049 PO59501 PO09972 PO67330 PO35172 PO10505 PO50657 PO50667 PO49770 PO55456 PO50651 PO45050 PO50646 PO45051 PO50637 PO41264 PO38021 PO10496 PO10561 PO49385

2004 UTTARANCHAL WATERSHED 2004 ELEMENTARY EDUCATION 2004 RAJASTHAN HEALTH SYSTEMS DEVELOPMEN 2004 ALLAHABAD BYPASS 2004 MAHAR RWSS 2004 ELEMENTARY EDUCATiON PROJECT (SSA) 2004 GEF Biosafety Project 2004 Karnataka UWS Improvement Project 2003 AP RURAL POV REDUCTION 2003 Tech/Engg Quality Improvement Project 2003 UPROADS 2003 TN ROADS 2003 Chatt DRPP 2003 Food & Drugs Capacity Building Project 2003 AP COMM FOREST MANG 2002 UTTAR PRADESH WATER SECTOR RESTRUCTU 2002 RAJ WSRP 2002 MUMBAI URBAN TRANSPORT PROJECT 2002 KERALA STATE TRANSPORT 2002 KARNATAKA RWSS /I 2002 MIZORAM ROADS 2002 KARN TANK MGMT 2002 Gujarat Emergency Earthquake Reconstnrct 2001 KERALA RWSS 2001 TECHN EDUC 111 2001 Grand Trunk Road Improvement Project 2001 KARNHWYS 2001 LEPROSY II 2001 KAR WSHD DEVELOPMENT 2001 RAJ POWER I 2001 MPDPIP 2001 RAJDPEPII 2001 POWERGRID II 2001 GUJARAT HWYS 2000 APDPIP 2000 IN-TA for Econ Reform Project 2000 NATIONAL HIGHWAYS 111 PROJECT 2000 IMMUNIZATION STRENGTHENING PROJECT 2000 UP POWER SECTOR RESTRUCTURING PROJEC 2000 WASTHAN DPlP 2000 UP Health Systems Development Project 2000 UP DPEP 111 2000 REN EGY II 2000 IN-Telecommunications Sector Reform TA 1999 MAHARASH HEALTH SYS 1999 RAJASTHAN DPEP 1999 UP SODIC LANDS II 1999 2ND NATL HIV/AIDS CO 1999 TN URBAN DEV II 1999 WTRSHD MGMT HILLS II 1998 DPEP 111 (BIHAR) 1998 ORISSA HEALTH SYS 1998 NATL AGR TECHNOLOGY 1998 AP ECON RESTRUCTURIN

0.00 0.00 0.00

240.00 0.00 0.00 0.00

39.50 0.00 0.00

488.00 348.00

0.00 0.00 0.00 0.00 0.00

463.00 255.00

0.00 0.00 0.00 0.00 0.00 0.00

589.00 360.00

0.00 0.00

180.00 0.00 0.00

450.00 381 .OO

0.00 0.00

516.00 0.00

150.00 0.00 0.00 0.00

80.00 62.00

0.00 0.00 0.00 0.00

105.00 85.00 0.00 0.00

96.80 301.30

- 64

70.00 500.00 89.00 0.00

181.00 500.00

0.00 0.00

150.03 250.00

0.00 0.00

112.56 54.03

108.00 149.20 140.00 79.00 0.00

151.60 60.00 98.90

442.80 65.50 64.90 0.00 0.00

30.00 100.40

0.00 110.10 74.40 0.00 0.00

111.00 45.00 0.00

142.60 0.00

100.48 110.00 182.40 50.00 0.00

134.00 85.70

194.10 191.00

0.00 50.00

152.00 76.40

100.00 241.90

0.00 0.00 0.00 0.00 0.00 0.00 1.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

10.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

20.00 16.96 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00

89.39 227.60 179.41 487.40

0.90 39.50

147.21 274.86 452.78 334.26 117.10 58.52

105.10 163.10 150.03 496.60 219.62 167.65 58.48

113.64 349.55 51.05 50.10

478.69 281.81

3.88 108.35 89.10 97.39 53.83

205.56 260.51

55.99 40.54

365.63 60.70 15.46 78.24 88.12 56.36

107.23 20.01 61.88 41.05 78.14 59.52 16.96 32.15 84.61 55.86 61.02

124.38

0.00 0.00 0.00

-2.40 -6.00 0.00 0.13 0.00

15.95 15.07 54.98 -2.79 -4.40 6.14

-4.70 69.37 41.02 56.68

3.62 30.17 3.84

16.22 324.06

19.23 19.72

258.69 80.81 3.14

52.58 70.60 31.45 3.47

107.96 156.51

1.44 10.73

231.50 -27.73 13.46 51.34 30.89 52.12 58.62 38.79 71.85 34.42 60.46 40.64 13.52 31.30 75.99 47.61 66.04

122.05

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 -6.58 -3.55 0.00 0.00 0.00 0.00 0.00 0.00 0.00

-31.75 19.22 0.00 2.24 5.63 0.00 0.00

-15.64 0.00 0.00

13.84 0.00

-7.27 15.00 0.00 0.00 0.00 0.00

-7.28 0.00

10.63 0.00

Difference between expected and actual

disbursements' Original Amount in US$ Millions

Project ID FY Purpose IBRD IDA GEF Cancel. Undisb. Orig Frm Rev'd PO35627 19961 WOMEN & CHILD DEVELPMENT 0.00 300.00 0.00 0.00 167.69 164.02 0.00 PO10511 PO10473 PO09995 PO09564 PO36062 P 0 4 3 7 2 6 PO35156 PO10531 PO44449 PO10529 PO35170 PO10476 PO10522

997 MALARIA CONTROL 1997 TUBERCULOSIS CONTROL 1997 STATE HIGHWAYS I(AP) 1997 ECODEVELOPMENT 1997 ECODEVELOPMENT 1997 ENV CAPACITY BLDG TA 1997 AP IRRIGATION 111 1997 REPRODUCTIVE HEALTH1 1997 RURAL WOMEN'S DEVELOPk 1996 ORISSA WRCP 1996 ORISSA POWER SECTOR 1995 TAMIL NADU WRCP 1995 ASSAM RURAL INFRA

TENT

0.00 0.00

350.00 0.00 0.00 0.00

175.00 0.00 0.00 0.00

350.00 0.00 0.00

164.60 142.40

0.00 0.00

26.00 50.00

150.00 246.30

19.50 290.90

0.00 262.90 126.00

0.00 0.00 0.00 0.00

20.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

46.50 13.04 0.00 2.34 5.66 0.94

45.00 0.00 6.72

12.09 95.00 25.01

0.00

46.34 55.72 25.74 0.10 2.19 3.92

35.10 50.55 5.61

23.35 16.65 21.29 10.32

92.61 73.49 25.74 3.75 9.64 9.33

87.56 43.59 13.44 56.15

113.65 65.30 27.76

29.37 16.34

-215.26 0.00 7.03 0.00

22.56 43.63 2.51

39.46 -1.06 54.20 27.76

Total: 6064.60 6650.60 21.00 299.46 7903.63 3254.42 21.07

- 65 -

INDIA STATEMENT OF IFC's

Held and Disbursed Portfolio M a r - 2004

In Millions US Dollars

Committed Disbursed IFC IFC

FY Approval Company Loan Equity Quasi Partic Loan Equity Quasi Partic 2003 Max Healthcare 1996199100 1992196197 200 1 2003 2003 200 1 1997 2004 1995 2001 2001 1995 1997 200 1 1997100 1995 2001103 2004 2000102 1998 2002 1989 1989 2004 1996 2002 2001 1997 1988 1997 2002 2002103 2003 1994 1992193 1997 2003 2001104 2001 2003 200 1 198419 1 2001103

Moser Baer NICCO-UCO NIT-SLP NewPath Niko Resources Orchid Owens Coming Powerlinks Prism Cement RCIHL RTL Rain Calcining SAPL SBI SREI Sara Fund Spryance Sundaram Finance Sundaram Home TCWIICICI TELCO Tata Electric UCAL UPL United Riceland Usha Martin Vysya Bank WIV WTI Walden-Mgt India Webdunia An, Alok Ambuja Cement Arvind Mills Asian Electronic BHF BILT BTVL Balrampur Basix Ltd. Bihar Sponge CCIL

Total Portfolio:

20.44 27.29

1.88 4.20 0.00

30.00 0.00

12.44 77.20 11.25 0.00 0.00 0.00 0.00

50.00 9.00 0.00 0.00

45.41 11.35 0.00

50.00 16.05 0.00

17.50 8.75

2 1 .oo 0.00 0.00 0.00 0.00 0.00 2.98

17.50 0.00 0.00 0.00

10.90 0.00 0.00

15.89 0.00 0.00 2.69

0.00 9.68 0.13 0.00

10.00 0.00 4.67 0.00 0.00 5.02 1.97 0.45 3.84 0.07 0.00 0.00 5.94 1 .oo 0.00 0.00 3.92 0.00 0.00 0.03 0.00 0.00 3.60 3.66 1.97 0.20 0.02 2.00 0.00 0.00 4.94 3.33 5.06 0.00 0.00

10.00 0.00 0.98 0.05 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

10.90 15.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 6.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

27.29 1.88 0.05 0.00

20.00 0.00

12.44 0.00

11.25 0.00 0.00 0.00 0.00 0.00 9.00 0.00 0.00

45.41 11.35 0.00

50.00 16.05 0.00

17.50 8.75

2 1 .oo 0.00 0.00 0.00 0.00 0.00 2.44 0.00 0.00 0.00 0.00 0.00 0.00 0.00

15.89 0.00 0.00 1.78

0.00 9.68 0.13 0.00 6.00 0.00 4.67 0.00 0.00 5.02 1.97 0.45 3.84 0.07 0.00 0.00 5.94 1 .oo 0.00 0.00 3.92 0.00 0.00 0.03 0.00 0.00 3.60 3.66 1.97 0.20 0.02 0.67 0.00 0.00 4.94 3.33 5.06 0.00 0.00

10.00 0.00 0.98 0.05 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

15.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 6.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

746.30 171.46 49.35 146.13 511.16 139.92 38.45 146.13

- 66 -

FY Approval Company

2004 CGL

2003 DQEL 2001 GI Wind Farms 2003 Niko Resources 2004 Ocean Sparkle 2004 Sealion Sparkle 2002 TML 200 1 Vysya Bank

2000 APCL

2004 CIFCO

Approvals Pending Commitment

Loan Equity Quasi Partic 7.10 0.00 1.90 0.00

25.00 0.00 0.00 0.00 0.00 22.07 0.00 0.00 0.00 1 .oo 0.00 0.00 9.79 0.98 0.00 0.00

10.00 0.00 0.00 0.00 3.00 0.00 0.00 0.00 5.30 0.00 0.00 0.00

17.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Total Pending Commitment: 77.19 24.05 1.90 0.00

- 67 -

Annex 10: Country at a Glance INDIA Integrated Disease Surveillance Project

POVERTY and SOCIAL

2002 Population, mid-year (miilions) GNI per capita (Atias method, US$) GNI (Afias method, US$ billions)

Average annual growth, 1996-02

Population (%J Labor force (%)

Most recent estimate (latest year available, 1996-02) Poverty (% of population below national poverty iine) Urban population (% of total population) Life expectancy at birth (yearsf infant mortality (per 1,000 live births) Child malnutrition (% of children under 5) Access to an improved water source (% of population) Illiteracy (% of population age ?5+) Gross primary enrollment (% of school-age population)

Male Female

KEY ECONOMIC RATIOS and LONG-TERM TRENDS 1982

GDP (US$ billions) Gross domestic investmenffGDP Exports of goods and serviceslGDP Gross domestic savingslGDP Gross national savingslGDP

Current account balancelGDP Interest paymentdGDP Total debffGDP Total debt service/exports Present value of debVGDP Present value of debffexports

194.8 21.7 6.1

18.3 19.2

-2.0 0.4

14.1 13.6

1982-92 1992-02 (average annual growth) GDP 5.6 6.0 GDP Der cadta 3.4 4.2

India

1,048.3 470

494.8

1.7 2.2

29 28 63 67

84 41

102 111 92

1992

244.2 23.8 9.0

21.8 21.8

-1.6 1.4

37.0 28.0

2001

5.2 3.5

South Asia

1,401 460 640

1.8 2.3

28 63 71

84 44 97

108 89

2001

478.5 22.3 13.5 23.5 25.5

0.1 0.8

20.4 11.7 14.2 84.7

2002

4.6

Low- Income

2,495 430

1,072

1.9 2.3

30 59 81

76 37 95

103 87

2002

510.2 22.8 15.2 24.2 26.3

0.6 0.7

20.6 13.9

2002-06

6.2 3.0 4.7

STRUCTURE of the ECONOMY

(% of GDP) Agriculture Industry

Services

Private consumption General government consumption Imports of goods and services

Manufacturing

(average annual growth) Agriculture Industry

Services

Private consumption General government consumption

Manufacturing

1982 1992

35.9 30.9 25.8 26.7 16.2 16.2 38.3 42.3

69.9 65.8 10.7 11.2 8.4 9.8

1982-92 1992-02

3.1 2.5 6.7 6.2 6.5 6.6 6.8 8.2

5.3 5.0 6.1 7.1

2001

25.0 25.7 15.3 49.4

65.9 12.5 14.1

2001

6.5 3.4 3.6 6.8

6.2 3.0

2002

22.7 26.6 15.6 50.7

65.0 12.5 15.6

2002

-5.2 6.4 6.2 7.1

-0.8 3.1

Jeveiopment dlamond'

Life expectancy

-

ZNI Gross ier primary :apita nrollment

1 Access to improved water source

lndia ~ Low-income group -

Economic ratlos*

Trade

T

1

Indebtedness

lndia ~ Low-income group _.

[Growth of Investment and GDP (%) 1

5 I 10

97 98 99 w 01

-GDI +GDP

Growth of exports and imports (%) I 20

10

0

-1 0

Gross domestic investment 5 7 7 2 1 6 9 5 -Exports -Imports Imports of goods and services 5.7 12 0 4 0 8 1

I \

- 68 -

India PRICES and GOVERNMENT FINANCE

Domestic prices (% change) Consumer prices Implicit GDP deflator

Government finance (% of GDP, includes current grants) Current revenue Current budget balance Overall surplusideflcit

TRADE

(US$ millions) Total exports (fob)

Marine products Ores and minerals Manufactures

Total imports (cif) Food Fuel and energy Capital goods

Export price index (7995=700) Import price index (1995=100j Terms of trade (1995=700)

BALANCE of PAYMENTS

(US$ millions) Exports of goods and services Imports of goods and services Resource balance

Net income Net current transfers

Current account balance

Financing items (net) Changes in net reserves

Memo: Reserves including gold (US$ millions) Conversion rate (DEC, /ocaliUS$)

EXTERNAL DEBT and RESOiJRCE FLOWS

(US$ millions) Total debt outstanding and disbursed

IBRD IDA

Total debt service IBRD IDA

Composition of net resource flows Official grants Official creditors Private creditors Foreign direct investment Portfolio equity

World Bank program Commitments Disbursements Principal repayments Net flows Interest payments Net transfers

1982 1992

6.7 12.6 7.7 8.8

.. 18.7

.. -3.2

.. -7.2

1982 1992

9,490 18,869 377 602 445 738

5,109 14,039 16,468 24,316 1,071 507 5,957 6,100 2,662 4,532

94 95 125 96 75 99

1982 1992

12,377 23,599 18.352 27,917 -5,975 -4,318

-335 -3,423 2,510 3,852

-3,800 -3,889

3,101 4,692 699 -803

4,896 9,832 9.7 30.6

1982 1992

27,546 90,264 1,395 9,326 6,983 15,438

2,054 7,697 172 1,395 72 267

394 363 1,352 2,543 1,180 1,563

0 313 0 244

1,889 2,678 1,397 1,954

98 834 1,300 1,119

146 828 1,153 292

2001 2002

3.1 4.3 3.9 3.5

17.5 19.1 -8.1 -7.4

-10.5 -10.9

2001 2002

44,915 53,000 1,237 1,381 1,262 1,900

33,370 38,353 57,618 65,474 2,043 2,368

14,000 17,640 9,882 12,746

90 101 93 100 97 101

2001 2002

65,580 77,986 73,706 84,254 -8,126 -6,268

-3,601 -4,882 12,125 14,448

398 3,298

11,359 13,682 -11,757 -16,980

54,106 75,428 47.7 48.4

2001 2002

97,516 105,210 7,015 5,141

20,402 21,642

9,327 13,042 1,372 3,029

569 637

384 410 365 -3,657

4,741 3,611 1,951 944

-1,569 -1,861

2,190 1,523 2,089 1,465 1,467 3,196

474 470 148 -2,200

622 -1,730

1 inflation (%) I

"I 97 98 99 w 01

-GDP deflator &CPI

Export and Import levels (US$ mill.)

80'ooo T

I O2 I 96 97 98 99 00 01

E Exports imports

Current account balance to GDP (%) I

Composition of 2002 deb! (US$ mill.)

G: 4,093 A: 5,141

F 51,061

A - IBRD B - IDA D - Other multilateral F - Private C ~ IMF

E - Bilateral

G - Short-term

ueveiopmeni CCUIIUIIIIC~ 1/YIU4

- 69 -

Additional Annex 11 : Information Technology INDIA: Integrated Disease Surveillance Project

Current System

The current system o f surveillance i s largely manual, and i s not adequate to handle both communicable and non-communicable disease in urban and rural areas. The system has significant deficiencies in meeting the surveillance requirements at the periphery/ block, district, state and national levels. Specifically, the existing infrastructure and the lack o f connectivity and integration at various levels do not support adequate collection and transfer o f data to the next level for timely decisions, proper feedback or analysis. Moreover, the lack o f central data, standardized reporting, monitoring, and feedback mechanisms results in duplicated information involving manual reports being sent under various national programs to different authorities. The laboratories at the periphery are not modernized and it i s difficult to take data from urban private practitioners. Thus, the information technology (IT) capacity o f the participating surveillance uni ts needs to be developed to create a comprehensive, consistent, and efficient system.

Methodology

The proposed IT solution i s based on a study o f the systems requirements conducted by M / s Microsoft Consulting Services. The team made field visits to Haryana, Tamilnadu and Maharastra to study the existing systems and to understand the user requirements. The field visits included meetings with Public Health Centers, Community Health Centers, District Hospitals, District and State laboratories etc. Meetings were also held in M i n i s t r y o f Health with Joint Secretary and team members in Delhi. Usefu l recommendations received during these consultations have been incorporated in the consultant's report while developing the IT solution.

I T Solution

The objective o f the IT initiative under this project i s to establish a decentralized state based system o f surveillance for communicable and non-communicable diseases, integrating existing surveillance activities and sentinel un i t s in urban and rural areas using the most optimum and feasible information and communication technology based solution.

T h e four key components o f the IT systems infrastructure requirements for the country wide system include Networking and Communication, Hardware Configuration, Software and Training.

IT Solution - Components

Networking

T h e communication backbone required to transfer data between blocks, districts, states and national un i ts will be comprised o f networking equipment (modem and router), switches and cabling, one time equipment installation, lease line/ISDN/intemet service providers' rentals, and the maintenance o f the network after installation and commissioning. The Information Flow Overview diagram in Figure 1 displays how data will move from one unit to another. Data from PHCs to Block and Block to District Surveillance office i s currently envisaged as a manual process.

Hardware

Stand alone computers will be provided down to the District level, with &alup modem and LAN set-up

- 70 -

with servers at district, state and national units. Hardware will also include client machines, printers, UPS, and there will be maintenance for the equipment after installation.

Software

In addition to system software, application software has to be developed, and licenses for the operating system, database server and messaging server with their clients should be deployed at all the three levels. At the district level, analysis software i s required to consolidate and analyze data received from various blocks on periodic basis. The analysis application will have to generate alerts on the basis o f the threshold level o f different diseases. There will be data entry applications at district level to enter data received manually from Block level and from private sentinel practitioners, nursing homes, hospitals and district laboratories. Reporting and feedback mechanisms will be built into the system. The Information Flow diagram in Figure 2 summarizes the inputs and outputs o f the software.

Training and Support

There will be a s k i l l set assessment o f the existing staff at all levels, followed by training (as appropriate for relevant employees) on hardware, networks and communications, system software, application software training, and end user functions. Support to staff will be provided by the contract for an agreed period following the training.

User Documentation

Documentation manuals w i l l be developed for all components. The system will also include online help to ensure ‘ease o f use’ for all end users.

Deployment

During the first year o f the project, the system will be fully developed. In years 2 and 3, the system will be deployed in the states in sequence (Le., Phase 1 states first, then Phase 2 states, and finally Phase 3 states).

- 71 -

A

Primary Health C

Figure 1

Proposed Information Flow - Over View

DDHS 0" managing N a t a 4 Pmgrams

far WD TB Lepmsy. Malana AIDS

DHSl manago NaDanai Pmgrams

fotPolio TB Leprosy Malana AIDS Surveillance Data , - froinzones

Private Sentinel Units /

Investigation Results ,

Investigafion / Investigation Results

/ Results

/

/ / / ' A

U Feedback I

E Analyzed Suweillance Information Feedback I 4

I 8 Reports 1

- 72 -

Figure 2

Data WUIU I"pYl.

Suweiilance Data in

h u m e n 1 *NM Simplified Pre -Formatted MPW I \

Data Desllnrlion 0"lp"b Proposed Information Flow

Survsiilance Data

1 Consolidated Reports

3 Consolidated Dala Transfer lo District 4 Feedback tiom DiStnol

Pedphen/

B k k Lab

3 Slatalical Ansipis 4 slate RBPOT19

D,st,d+ Integrated Disease - Surveil la m e System

District

Distnd Lab Medical Colleger

Sentinel U nils

state 71 I, Medicai caiiagss

Nationai /

National

Suweiilance data Lab NICD,ICMR

N atbnsl

1 Trends Annaiyris 2 Statistical Anaiysis : 3 Feedback Io State

Dislrid SuNeilianCB mast Nalimal Piagam

br POlb, LBP(0IY. maiaria, TB, AIDS Distnd Lab h a l a Senbnel U"ib

9S18 SUNdWCB masr National Pmgram for Wia, Leprosy, malana. T0. AiDS Sale Lab

Natiomi SUN elllanct mer Nabnal Lab

- 73 -

Additional Annex 12: Training Strategy and Plan INDIA: Integrated Disease Surveillance Project

The Integrated Disease Surveillance Project (IDSP) i s action oriented, district centered, and decentralized. Human Resource Development i s one o f the important components o f the project.

The following key issues underlie the development o f the Training Strategy and Plan:

0

0

0

0

0

IDSP doses not intend to employ additional staff considering the financial position o f the states and long term sustainability. Existing personnel will be provided training to undertake surveillance activities more efficiently integrating even non-health workers for th is activity if necessary. As far as possible training will be provided locally at the sub-district level, some at district and small numbers at the state and central levels. Public private partnership i s an important component in IDSP both in terms o f training provider and the trainee. the widely used cascade method o f training has not provided good quality training and this will be taken into consideration in the development o f the training strategy for IDSP.

Training Needs Assessment

An assessment o f training needs was carried out in 6 states in India to understand the available infrastructure, human resources and perceived needs o f the program in terms o f human resource development. The key inferences that emerged from this assessment were as follows:

Training and sensitization workshops for IDSP activities are essential for the successful implementation o f the program. There i s wide variation in the training needs and available infrastructure between different states. While some o f the states have established training centers 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% o f 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. Staff trained in public health are very few, especially at the district level and above. Th is means that training in surveillance needs to be imparted to all relevant personnel, including the district and state level officers. Duration o f training for IDSP should be short and it i s not possible to spare health workers and doctors for more than 2-3 days at a time. Consultants will be required at state level for at least the f irst 2 years to effectively implement the IDSP activities in addition to training o f personnel. User friendly training manuals should be made available.

The training strategy includes three broad types o f training - induction training, continuing training, and sensitization workshops. The need for additional special-purpose training will be identified and implemented as the project proceeds.

- 74 -

A. Induction Training Programs

There are 8 separate training programs planned under the program to meet the needs o f the following groups o f personnel in the program:

Training o f the State and District surveillance teams - The trainers Training o f the Medical officers from PHC, CHC, urban health services and medical colleges Training o f the Medical officers from the private sector hospitals, including SSPs, M C and others Training o f the Peripheral workers - MPWs, ANMs, health supervisors, N G O field workers etc Training o f Microbiologists and Lab technicians (State and District level) Training o f Lab technicians (Sub District level) Training o f Data entry operators (State, District and Sub District level) Training o f Data Managers (District and State level).

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 in the usual cascade mode o f training.

Three levels o f trainers were identified: Level- 1 Trainers Level-2 Trainers Level-3 Trainers

1. The responsibility o f training in the program will be with a network o f national institutions selected on the basis o f 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 o f Health and Family Welfare. These will be the Level-1 Trainers. A Consortium o f institutions may also qualify provided there i s clear definition o f roles and responsibilities o f each institution.

Level 1 Trainers - National Network o f training Institutions:

A total o f 30 institutions will be chosen to focus on training in surveillance activities and specific laboratory training. Institutions specialized 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 l i s t the 30 institutions based on certain criteria. The State Surveillance Unit would be free to choose the appropriate ones for their state.

The criteria proposed for choosing training institutions are as follows:

Criteria: Epidemiology Training Center: 0

0 0

0

Recognized training institutions with experience in post graduate teaching in the field o f community medicinel public health, and microbiology; Adequate training infrastructure and equipment; Key resource person in the area o f epidemiology, microbiology, medicine and pediatrics who are willing to be resource person for training if selected; Preferably, experience in health surveillance activities.

Criteria for Laboratory Training: 0 0

Training institutions with experience in the field o f microbiology and biochemistry; Adequate training infrastructure and equipment;

- 75 -

e

0

Key resource person with expertise in the field o f microbiology who are willing to be resource person for training if selected; Preferably, experience in health surveillance activities.

Criteria for Institutions for training in data management: Institutions with prior experience in training in data management; Adequate training infrastructure and equipment; Key resource person with expertise in the field o f statistics and data management who are willing to be resource person for training if selected; Preferably, experience in health surveillance activities.

e e e

e

2. Level -2 Trainers: The level 2 trainers would be members o f the district and state surveillance team who have been trained by the Level 1 Trainers. They would take the primary responsibility o f training the district and sub-district personnel (Category 11, I11 and V trainees). 25% o f the faculty for district level training will be from the selected national institutes o f training.

3. Level 3 Trainers: These would be the Block Medical officers who would in turn train the Sub Block staff (Category IV trainees). 25% faculty for Health worker training at the sub-district level will be from state and district surveillance team (2 levels higher).

Ouality Assurance

Mixed model series and parallel mode o f training i s planned for the program so that loss o f training quality i s minimized. In addition, there will be

e e

Annual independent extemal evaluation o f training Continued h d i n g for training by the institutions and groups will be dependant on the evaluation results

- 76 -

Below, in Table 1, Table 2 and Table 3 we show the trainees, the site o f training and the training plan for the induction level training,

Table 1. The trainees for induction trainin! Category I

I1

I11

IV

v

VI

VI1 VI11

Level State and District level Surveillance Teams

Medical Officers

Clinical Medical officers

Sub Block staff

State and District Level Laboratory training

Sub District Level Laboratory training Data entry operators Data managers

‘rainees State Surveillance Officer (SSO), State Program managers, State Microbiologists / Lab technicians and State level Data Managers District Surveillance officer, 2 District program Managers, District Microbiologist / LT and District Data Managers RRT members Medical Officers o f the PHCs, CHCs and Urban Health sector. MOs o f the SPM departments o f local Medical colleges. MOs o f NGOs / Mission Hospitals Medical Officers o f the Hospitals, Sub district Hospitals, Medical College HosDitals. SPPs MPWs (Male / Female), Health Supervisors, N G O volunteers, unregistered Medical Dractitioners State and District level microbiologists / LT. Also o f the urban health sector. Also Microbiologists from local Medical Colleges PHC / CHC / Urban dispensary LTs

DEOs at CHC. District and state level

Gumbers 0 per state

0 per district

70 per district

30 per district

350 district

5 per district

5 per district

15 Der district I Statisticians at District and State level 2 Der district I

Nodal Officers: Nodal officed District Surveillance Officer at district level does not automatically imply the DHFWO but should be the officer who i s actually involved with the program and would usually be a Dy DHO/ Dy CMO/ Program officer dealing with surveillance. S/He should preferably be a specialist in public health.

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Table 2. Site of induction training

rRAINERS Level 1 - Selected National Level

Maximum time that personnel at district and sub-district level can be spared i s 2-3 days. This means that most o f the training i s district and sub-district level itself. Training will be preferably at one level higher than the working environment

Site Regional I State I

Level 2 - State and District Surveillance Team

I1

I11

IV

District H Q

V

Support from Level 1 Trainers CHC Team with selected M O PHCs

V I

CHC

VI1 VI11

District Public Health laboratory staff Representatives from Level- 1

TRAINEES

District H Q

District and State Surveillance team

institutions Soft ware agency Identified training institutions

Medical Officers o f the PHCs, CHCs and Urban Health sector. MOs o f the SPM departments o f local Medical colleges. MOs o f NGOs I Mission Hospitals Medical Officers o f the Hospitals, Sub district Hospitals, Medical College Hospitals, SPPs MPWs (Male I Female), Health Supervisors, N G O volunteers, unregistered Medical Dractitioners

District H Q Regional I state

State and District level microbiologists I LT. Also o f the urban health sector. Also Microbiologists from local Medical Colleges

institut '

Training for lab assistants at CHC / PHC I

Data entry operators Data Managers district

soft w Identified training institutions /Regional I s t a r

Training Institutions I

Surveillance Team

Support from Level 2 Trainers

Level 1 trainers - Identified training institutions

Segional I State

Duration 6 days

3 days

1 day

2 days

6 days

3 days

2 days 3 days

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Table 3. Plan for induction training

0 Curriculum consensus meeting by training institutes

Trainers Level 1

institutions) (3 0

Level 2 (230 districts)

Level 3 (230 districts)

Level 1

institutions) (3 0

Level 2 (230 districts)

Level 1

Trainees State and Distr ict Trainers 30x 9 states

MOs o f PHCs I C H C etc 70x230 districts (16100)

M O s o f Hospitals 30x 230 (6900) M P W s etc 6 x 4 ~ 1 5 ~ 2 3 0 (82800)

State I Distr ict Trainers Lab 2 x 3 0 ~ 9

LT o f PHC I CHC lox 230

Data Management 2x 230

h -

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B. Continuing training

0 On-the-job supervision and training 0 Web based training - credit system 0 Regular refresher training 0 Annual peer interaction - C M E

C. Sensitization Workshops

The sensitization workshop i s essential to successful social mobilization. Short hal f to one day sensitization workshops will be conducted as part o f IEC activities to make stake holders aware o f the IDSP and ensure their participation in the program at different levels. The groups which need sensitization:

State Level - Policy makers and administrators at state, district levels including Health secretaries, secretaries o f related sectors. Heads o f departments o f medical education and health services. Medical college principals, District collectors, District Level - NGOs doing and interested in disease surveillance. Representatives o f Indian Medical Association (IMA) and Indian Association Pediatrics (IAP). Block Level - Panchayat leaders, School teachers, Anganwadi workers, Sentinel private practitioners and Medical practitioners o f altemate systems o f medicine like ayurveda, unani, homeopathy and unregistered practitioners in the locality.

0

0

0

Conclusion

Total o f -1 12,000 personnel will need to be provided training during the induction phase o f the Integrated Disease Surveillance Program. The phased induction o f the program will make it feasible for the induction training to be completed in 3-6 months time to cover 9 states considered for the 1st phase o f the program. Most o f the personnel will be provided specific training for performing the tasks for IDSP at sub-district and at the district level and the duration for district and sub-district level training will be short (2-3 days only). The quality o f training can be assured by developing a mixed model o f series and parallel system where core trainers are represented in the lower order training sessions and having extemal evaluation o f the training. Retrospective financing allowed in the program will make it feasible for the state and central governments to initiate components o f training even before the World Bank financing i s made available.

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Additional Annex 13: Quality Assurance of Laboratory Data - Terms of Reference INDIA: Integrated Disease Surveillance Project

The GO1 invites proposals from interested and experienced organizations to carry out the work described below.

1. Background

The government o f India, with the assistance o f the world Bank, proposes to implement an Integrated Disease Surveillance Project (IDSP). The project has four components: establish and operate a central-level disease surveillance unit; integrate and strengthen disease surveillance at the state and district levels; improve laboratory support; and training for disease surveillance and action.

The project will be implemented in phases as shown below:

Phase 1 states, which will implement IDSP beginning in GO1 FY2004-05 are Andhra Pradesh, Himachal Pradesh, Karnataka, Madhya Pradesh, Maharashtra, Orissa, Tamil Nadu, Mizoram and Kerala.

Phase 2 states/UTs, which will implement the IDSP beginning in GO1 FY2005-06 are Chhattisgarh, Goa, Gujarat, Haryana, Rajasthan, Uttaranchal, West Bengal, Manipur, Meghalaya, Tripura, Chandigarh, Pondicheny, and Delhi.

Phase 3 states/UTs, which will implement IDSP beginning in GO1 FY2006-07 are Uttar Pradesh, Bihar, Jammu and Kashmir, Jharkhand, Punjab, Arunachal Pradesh, Assam, Nagaland, Sikkim, A & Nicobar, D & N Haveli, Daman and Diu, and Lakshadweep.

One o f the objectives o f the component on laboratory support i s to improve the quality o f laboratory services, particularly as they relate to the health conditions under surveillance. The laboratory data are used to increase the specificity o f diagnosis and verify the cause o f suspected outbreaks. As the current quality o f laboratory activities across districts and states i s unknown it will be necessary to conduct a baseline survey o f the quality o f laboratory services for the diseases under surveillance in the f irst year o f 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.

EQAS i s evaluation by an outside agency o f performance by a number o f 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 o f accuracy can also be made. Such external assessment i s essential for maintenance o f quality standards in laboratories. This external assessment should be complemented by laboratories’ internal evaluation through internal quality control and standardization o f procedures.

The diseaseskore conditions under surveillance in IDSP are:

Regular Surveillance: *

Vector Borne Disease Water Borne Disease

: 1 Malaria : 2 : 3 Typhoid

Acute Diarrhoeal Disease (Cholera)

- 8 1 -

Respiratory Diseases Vaccine Preventable Diseases Diseases under eradication Other Conditions

Other International commitments: Unusual clinical syndromes (Causing deathhospitalization)

: 4. Tuberculosis : 5 Measles : 6 Polio : 7 Road Traffic Accidents

(Linkup with police computers) : 8 Plague, Yellow fever : 9 Menigoencephalitis/Respiratory stress

Hemorrhagic fevers, other undiagnosed conditions

Sentinel Surveillance

Sexually transmitted diseasesiBlood borne : 10 HIV/HBV, H C V Other Conditions : 11 Water Quality

: 12 Outdoor Air Quality (Large Urban centers)

The laboratory network for IDSP will be established at five levels o f 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 PeriDheral Laboratories

PHC Laboratory Tuberculosis

Malaria Typhoid

Water Quality

Cholera

Sputum AFB smear Confirms 0.5% Collect random sample o f Sputum for Culture at L 3 Lab

Blood smear for Malaria Confirm 0.5% Rapid diagnostic test Confirm 0.5% (Typhi Dot) Collect blood for culture at L 2 Level Kit for chlorination test Rapid test kit for fecal contamination collect random sample o f water for colony count at L 2 lab Collect random sample o f stool For testing at L 2 lab

Confirms 0.5% Confirms 0.1%

1.

2.

3.

4.

5.

1.

2.

3.

4.

5.

6.

7.

8.

9.

Conditions

Tuberculosis

Table 2 - Activities to be undertaken by the District Laboratories

Malaria

Typhoid

Cholera

Water Quality

Conditions

Tuberculosis

Malaria

Typhoid

Cholera

Water Quality

Test

Sputum AFB Smear

Blood smear

Rapid Diagnostic test and Blood culture

Stool culture Cholera Toxin Test

Chlorination tests and colony count

Rapid test for fecal contamination

Confirmation

Confirm 1% (both +ves and -ves) from Peripheral Labs

Confirms 1% from Periphery

Confirms 1% Typhi Dot tests positive samples

ADD

1% o f samples from periphery

Additional Tests

Blood culture on 1% o f suspected typhoid

Stool culture confirmation in 0.1% o f suspected cholera

Colony count tested in 5% o f samples

Table 3 - Activities to be undertaken bv State Laboratories

J&t Confirm at i o n

AFB Culture and Sensitivity Perform 1% of positive culture from district level

Confirm 1% from districts

Confirm 1% o f bacterial isolates at district level

1% of cholera isolates from districts

Sensitivity Testing in S.typhi isolates

Cholera culture and typing

Cholera toxin test

Colony count Confirms 0.5% from district levels

NCD surveillance Blood sugar, HDL, LDL

Polio Follow present procedures

Measles

Leptospirae M A T Test for Leptospira

Ki t for Measles IgM antibodies

Objective

Identify magnitude of MDR TB

Pattern o f AMR for S.typhi typing

Identify pattern of bacterial infection

Risk factor surveillance for NCD

Confirm Polio

Confirm Measles

Confirm Leptospirae

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10. Dengue IgM test for Dengue Confirm Dengue

1 1. Hepatitis Serology for Hepatitis A, E, Confirm 1% o f Quality control B, c samples from district Hepatitis work

12. Anthrax Identification o f Anthrax Confirm Anthrax

13. Plague Identification o f plague Confirm Plague

2. Obiective o f the assignment

The main objective o f the assignment i s to conduct the baseline survey o f the quality o f laboratory data for the diseases to be covered under the IDSP in the 9 states covered under Phase 1 o f the project.

3. Proposal

The Survey Organization i s expected to carry out the following tasks which should be addressed in the proposal:

8 Prepare a detailed protocol for undertaking the survey including the overall approach to the assessment o f laboratory quality in a cross-sectional survey, survey methodology, survey instruments, sample design, and sample size Details o f the manner in which quality o f the specific laboratory tests will be made. 8

8 Pre-test tools and questionnaire 8 Carry out the survey 8 Data entry and analysis 8 Outline o f report 8 Schedule o f work through submission o f the final report

The work should be completed within 48 weeks o f appointment.

In addition to the above, the proposal should contain

8

8

4.

8

8

8

8

8

A detailed cost estimate Details o f the qualifications o f the organization and i t s staff to carry out the quality assurance baseline survey, including cv’s o f the key investigators involved. Details o f the way in which the organization will manage the survey and lines o f responsibility

Data services and facilities to be provided by the Client

Client will nominate a coordinator who will liase between the client and Survey Organization during the survey Client will promptly furnish to the Survey Organization necessary information related to the contract and carrying out the survey. Client will make necessary arrangements to provide entry/exit passes for visits o f Survey Organization personnel during the course o f the assignment The cost o f litigations andor arbitrations with third party and the cost to meet the award o f litigations/arbitrations will be borne by the client Client will inform StateIDistrict authorities about the survey and the need to extend support and cooperation to the Survey Organization

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5.

6.

Client will make sure the Survey Organization has adequate resources and funds for proper execution o f tasks and related activities Client will arrange for meeting with the Survey Organization in connection with the survey

Final output

Survey protocol Fully documented electronic copies o f datasets collected during the survey Survey report (including suggestions, based on the survey results, for ways in which the quality o f laboratory data can be improved).

ComDosition o f the review committee to monitor tasks o f the Survey Organization

A review committee will be appointed to monitor tasks undertaken by the Survey Organization and shall consist o f the following

Director N I C D Joint Secretary I /C Public Health, MOHFW

Nominee o f internal Finance Division ADG (Integrated Disease Control Project)

7. Criteria for assessing proposals

Criteria for assessing proposals will be given in the information provided to consultants with the ‘Request for Proposals’.

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Additional Annex 14: Existing Disease Surveillance Systems in India INDIA: Integrated Disease Surveillance Project

At the time o f Independence the heavy disease burden experienced by the population o f India was mostly due to infectious diseases. India introduced programs for specific diseases, frequently in l ine with the intemational disease control priorities as they emerged after World War I1 and the establishment of the United Nations and the various technical agencies, including WHO. Each o f these disease-specific control programs included i t s own surveillance mechanism. The programs were (in chronological order):

0

0

0

0

0 1972 - nutritional surveillance; 0

0

0 0

0

0 cancer registries.

1953 - National Malaria Control Program; 1955 - National Filaria Control Program; 1955 - National Leprosy Control Program; 1962 - National Tuberculosis Program;

1980 - Guinea worm (Dracunculiasis). Eradication certified in 2000; 1984 - rheumatic fever and rheumatic heart disease; 1985 - Universal Immunization Program for 6 vaccine preventable diseases including polio; 1985 - National AIDS Control Program; 1996 - The National Polio Surveillance Project;

The National Institute for Communicable Diseases, Indian Council for Medical Research (ICMR) and the Central Bureau o f Health Intelligence (CBHI) are national level resources for surveillance efforts. There are also Public Health Laboratories in most states. The State Health Systems Projects have strengthened disease surveillance activities to varying degrees in 7 states.

The Family Welfare Department carries out surveillance activities for family planning, child and matemal morbidity and mortality. With regard to nutrition, the Department o f Women and Child Development monitors child malnutrition especially Protein Energy Malnutrition (PEM) through the nutritional surveillance systems designed by the National Institute o f Nutrition. However, this i s limited to a few states. The Integrated Child Development Services (ICDS) program also monitors nutritional status o f children at the village level.

National and intemational experience indicate that the aggregate surveillance system has the following constraints:

1. limited. Resources for the disease control programs have been guaranteed through central funding. This has also resulted in central control, and limited capacities and involvement by the states. Involvement o f states and districts i s largely as collectors o f information who forward it to the center, which then makes program decisions that are then transmitted to the states, who are then expected to take the actions specified by the center. At the same t ime there i s no involvement o f the village level in the surveillance system, either in providing information o n selected diseases or in the dsease control response.

Surveillance activities are centrally controlled through the MOHFW and the role o f other players i s

2. There i s no overall management structure for the disease surveillance activities at the center. Similar administrative fragmentation exists at the state, district and health facility levels as well. The result i s duplication o f activities, inefficient use o f resources and, overall, a failure to share information between dsease control programs.

Surveillance activities (and disease control activities generally) are fragmented and uncoordinated.

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3. Laboratory support for surveillance varies greatly between diseases - for some, such as TB, diagnosis i s dependent on microscopic examination o f sputum and local capacity i s being developed to do this; for malaria, extensive microscopy i s carried out but l i t t le use i s made o f the results for diagnosis as the delay in results i s too great; for others, such as leprosy, there i s no longer a requirement for laboratory confirmation. As with other aspects o f surveillance, the laboratory input, required for confirmation o f diagnosis o f suspected infectious disease cases, i s fragmented due to the vertical organization o f the programs, with resulting ineficiencies.

4. level and the system i s not action-oriented. Data management and analysis i s largely carried out at the central level. W h i l e some early initiatives are being undertaken in some states, overall there i s little, if any, capacity for either data management or analysis at the state and district levels. Data management, analysis, reporting and dissemination makes only limited use o f computer-based technology and modem communications. Generally, the surveillance systems are not action oriented and are not able to respond effectively to disease outbreaks. The overall result i s a passive periphery which waits for results and instructions which often arrive too late to take effective action.

Data management and use o f modem technology i s limited, there i s little analysis o f data at any

5. surveillance. In fact, the surveillance system relies almost totally on the public health system as a source o f information. This i s a critical limitation as the private sector provides more than 80% o f outpatient care; this failure to involve private providers, particularly as sources o f information on disease outbreaks, seriously l im i t s the overall validity o f the surveillance information.

The private practitioners and N G O stakeholders in the health system are not involved in disease

6. burden. Amongst the communicable diseases (CDs) these include acute respiratory infections and diarrhea. With the exception o f malnutrition, the current system does not provide information on any non-communicable diseases (NCDs).

The system provides only limited information on a number o f diseases which have a high disease

The project proposed here will provide assistance for the initial steps needed to relieve these constraints. The project wil l: revise the role o f the center and states; decentralize responsibility for implementation o f disease surveillance activities to the states and districts; involve the community and private sector; promote integration o f disease surveillance activities; strengthen and integrate laboratories into the surveillance system; introduce modern computer and communications technology, facilitating an 'action-oriented' surveillance system; and include major non-communicable diseases (and/or their risk factors) in the health conditions.

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Additional Annex 15: Institutional and Organlzational Arrangements INDIA: Integrated Disease Surveillance Project

Executing Agencies

MOHFW, State-level Health Directorates

Institutional Arrangements

Central Level: The project w i l l be coordinated by the Ministry o f Health and Family Welfare (MOHFW), New Delhi. A Central Disease Surveillance Unit will be established for th i s purpose. I t will also act as the Project Secretariat. The unit will be headed by a Joint Secretary and include a Deputy SecretayDirector from Public Health Division, technical officers seconded from DGHS, Director (Finance) and consultants (Procurement, Finance) as required. The unit will be staffed with officers on deputation from NICD, I C M R and other organizations under MOHFW, and consultants.

This unit w i l l report directly to both the Secretary for Health and the Secretary for Family Welfare. The unit wi l l also report to the Central Surveillance Committee which i s chaired by the two Health and Family Welfare Secretaries and has members representing DGHS, DG (ICMR), Dir (NICD), Dir (NIB), JS(PH), representatives from the Ministr ies o f Environment, Forest, Tribal Welfare, Agriculture, Rural and Urban Development, Water and Sanitation and NGOs. The committee will meet quarterly to review the surveillance reports prepared by the Surveillance Unit and as required during disasters and epidemics.

Organigram

National Surveillance Committee

Chair: Secretary Health, Secretary F W

National Surveillance Unit

Joint Secretary

I

I I Deputy Director General

Assistant Director General

Consultant I T

Consultant HRD & IEC

Deputy !Secretary Director Finance

Under Secretary

Consultant Procurement

Consultant Finance

- Data Manager -Data Processing Assistants -Data Entry Operators -Support Staff

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State Level: The state surveillance unit will be headed by the State Surveillance Officer (SSO). This officer will be responsible for financial management o f the project within the state, state level procurement, annual work plans management and technical support to the districts and annual progress review o f the program in the state. The officer will receive technical support from DHS, consultants (Lab services, Procurement, IEC, Finance), Accounts Officer, Data Manager and support staff. This unit w i l l report to the Secretary for Health and Family Welfare (or equivalent) and the State Surveillance Committee, an Empowered Committee responsible for coordination and policy making. T h i s Committee will have Secretary Health as Chair, Director Public Health as co-chair and include: Program Officers for various health programs such as RCH, AIDS, TB, Malaria etc, Department o f Finance, representatives from professional organizations such as the IMA, NGOs. The SSO will be the Member Secretary. The committee will meet on a regular basis to review the surveillance reports prepared by the Surveillance Unit and as required during disasters and epidemics; it will also liaise with sister state committees to coordinate activities in case o f multi-jurisdictional outbreaks.

Organigram

State Surveillance Committee

Chair: Secretary Health & Family Welfare Co-Chair: Director Public Health

I

I Executive Sub-committee

State Surieillance Unit

State Survkillance Officer -DHS officers -Consultants -Accounts Officer -Data Manager-

District Level: The District Surveillance Unit will be headed by the Deputy Chief Medical Officer as the District Surveillance Officer (DSO) and include Data Processing Assistant, Data Entry Operator, Accounts Officer and support staff. The unit will report to the District Surveillance Committee chaired by the District CollectorKEO. This committee will include representatives from other departments, PRIs, NGOs. The Committee wi l l meet once a month and as often as needed during an epidemic; it will also liaise with sister district committees to coordinate activities in case o f multi-jurisdictional outbreaks. Reports o f these meetings will be forwarded to the State Surveillance Units. The Unit will be funded through a District Disease Control Society (or District Health Society) under the overall supervision o f the State Department o f Health and Family Welfare. The society will be responsible for district procurement and implementation o f district annual work plans and financial management systems.

- 89 -

Organigram

District Surveillance Committee

Chair: District CollectorKEO

District Surveillance Unit

District Surveillance Officer -Data Processing Assistant -Data Entry Operator -Accounts Officer -Support Staff

I

I I

- 90 -

Additional Annex 16: Strategy for Tribal Populations April 2003

INDIA: Integrated Disease Surveillance Project

Project Objectives and Components

T h i s annex describes the project’s approach to meeting the requirements o f the Bank’s O.D. 4.20 on how it would ensure that (a) indigenous people in the project areas receive culturally-compatible benefits and (b) there are no adverse effects on them.

The major project objectives are (i) the establishing o f state-based system o f 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 level, and (ii) to improve the efficiency o f the existing surveillance activities o f disease control programs and facilitate sharing o f 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.

For tribal populations this means that there i s (i) strengthened link between the tribal communities and the health system leading to greater credibility o f the health system, (ii) less reached and unreached areas where the tribals live are brought into the fold o f 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 o f the health o f the tribals - project i s expected to monitor a set o f communicable and non-communicable diseases.

The project covers the entire country though the coverage w i l l be phased with Tamil Nadu, Andhra Pradesh, Kamataka, Maharashtra, Mizoram, Orissa, Madhya Pradesh and Himachal Pradesh to be taken up in the f i rst phase. Many o f these states have substantial tribal populations.

The project’s components are: 0

0 0 Improve laboratory support 0

Coordinate and decentralize disease surveillance Integrate and Strengthen disease surveillance at the district and state levels

Training for disease surveillance and action

Project Benefits

Project beneficiaries would consist o f all the tribal population in the project states and districts. The major benefits from the decentralization o f disease surveillance mechanisms to the state, district and community levels would be increased interaction between the health system and the c o m m ~ t y , enhanced community knowledge o f the community o f disease and control measures, and improved monitoring and tracking o f the disease burden o f tribal groups. The integration o f the various disease surveillance programs would provide more complete and coherent health information, better monitoring o f disease burden and improved health system response in the tribal areas too. In the tribal areas also, community-based information i s a

- 91 -

key input to the District Surveillance Unit (DSU) which wi l l coordinate all the analysis, response and feedback o f information. These should have a positive impact on the tribals and their health status.

Baseline Data Population, leprosy prevalence and trends 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 o f the country’s population (68 mill ion out o f 846 million). Seven Indian states account for more than 75 percent o f the tribal population. O f the Phase I states, 2 states have tribals constituting more than 20 percent o f the state population and the others have significant tribal populations.

Gender 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 o f 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 o f women.

Cultural Aspects The propensity o f sub-groups such as tribals and women to seek the necessary treatment i s low for various reasons:

0

0

0

0

their knowledge regarding symptoms i s inadequate; myths, superstitions and stigma associated with many diseases are widely prevalent; there are widespread misconceptions about the cause and method o f spread o f diseases; there i s l ow awareness o f availability o f treatmenddrugs, and there i s greater reliance on indigenous medical practices.

Data indicate that tribal populations are less likely to access diagnostic and treatment services in a timely manner.

Settlements and Migration 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 sub-groups do. Some tribal groups are nomadic and undertake seasonal migration in response to the need for livelihood or employment. In addition, economic deve1,opment i s forcing out-migration from traditionally tribal areas into cities, and often to the margins o f 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 below.

Legal Framework The Fifth and Sixth Schedules o f the Indian Constitution provide protection to tribal populations on account o f their disadvantages. The Fifth Schedule designates ‘Scheduled Areas’ in large parts o f central India in which the interests o f 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 o f the states o f Assam, Meghalaya, Tripura and Mizoram in the North-East. This schedule provides for the creation o f 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 o f the Tribal Subplan since the Fifth Five Year Plan o f the Government o f India and the

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Integrated Tribal Development Approach, adopted and implemented with some modifications by subsequent government programs.

Articles 46 and 47 o f the Constitution o f 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 o f the weaker sections o f the people, and in particular, o f the Scheduled Castes and Scheduled Tribes, and shall protect them from social injustice and all forms o f exploitation”. Article 47 states that it i s the duty o f the State to raise the level o f nutrition and the standard o f living o f the people, as well as to improve public health.

An important objective o f the National Health Policy, 2002 i s the overriding importance to be given to ensuring a more equitable access to health services across the social and geographical expanse o f the country and ensure that the access to, and benefits from, the public health system i s ensured for tribals along with women, children and other socially disadvantaged sections o f 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 o f 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 o f 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.

Institutional Mechanisms The Government o f 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 o f 30,000 and one sub-centre to 3000 instead o f 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.

Consultations In order to design strategies to enhance the participation o f tribals in disease surveillance, detailed consultations were held with tribal communities in Chhattisgarh state. North Arcot District Health Information Network (”HI), Kerala Government project on District disease surveillance program, BAIF surveillance, the Gadchiroli health program, Comprehensive Rural health system project, were among the various programs studied and NGOs consulted to understand the needs o f the tribal communities. Discussions were also other stakeholders including Health Department Officials, Medical Professionals, Medical Colleges, and Private providers. National level workshops and state level consultations were held in Maharashtra, Uttar Pradesh and Tamil Nadu to elicit suggestions and views for reaching out to tribal communities. The consultations had representation from the grassroots along with the NGOs, Block and district level administration, representatives o f the IMA, state level program staff and state health secretaries. The draft strategy was shared in these consultations and the same was finalized based on feedback.

Strategy In order to ensure active involvement o f the tribals and that they benefit in a culturally-compatible manner, the project would ensure that:

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0

0

0

0 0

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 o f local tribal volunteers in awareness generation campaigns for the tribal community; and for information collection in coordination with the health system staf f Sensitization o f 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 o f culturally-compatible IEC material in the tribal areas; Monitoring and evaluation based on data disaggregated by tribal status and gender to allow tracking o f efficacy o f the IDSP among these groups.

The National and state-level Project Implementation Plans identify tribal populations as a target group with unique problems o f physical and social access requiring culturally sensitive strategies. The project emphasizes two institutional initiatives which would address the needs o f the tribal people:

0 Decentralization o f planning and implementation to the state and district levels. This would increase the involvement o f 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 annual plans with emphasis on the needs o f special groups. This includes carrying out special mobilization campaigns in the tribal areas; and Better relationship between the health system and the tribals through volunteers w i l l lead to improved geographical coverage, particularly in remote and unreachable tribal areas.

0

The project will coordinate with other health activities being carried out by the State Health Directorates for tribal areas. Partnership will be developed with the Tribal Development Departments who 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 o f tribal groups. Population specific information will be used to develop culturally sensitive awareness material for both public and providers.

Implementation and Local Participation Based on feedback received from tribal communities during consultations and fieldwork on major aspects related to (i) socio-cultural and economic barriers in seeking health care, (ii) decision making process about health issues, (iii) patterns in seeking health care, (iv) socio-cultural factors in the care o f sick, (v) gender related barriers, (vi) impressions on the credibility o f the health system, (vii) information sharing, (viii) requisites for participation in disease surveillance and (ix) major disease conditions; a broad set o f activities have been identified under the tribal strategy.

The project seeks to address this by (i) social mobilization strategies focused on tribals and their collectives including tribal women self-help groups and mahila mandals; (ii) preparation o f simple case definitions for diseases that tribals including women can use; (iii) sensitization and training programs planned under the project wi l l be adequately “gendered” so as to sensitize field level staff and community volunteers to the special needs o f tribal women; (iv) the training and awareness generation campaigns address the tribal perspective.

Cost estimate and financing plan N o 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.

Monitoring and Evaluation Disaggregated data for tribals along with women and scheduled castes would be generated from a revised

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routine monitoring system. The project wi l l monitor increased knowledge o f 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.

Rumor registers are to be maintained at every health center and a wide set o f informers have been identified who include village elders, leaders, Anganwadi workers, se l f help groups, youth groups and other collectives. The information on disease occurrence and outbreak reported by these various informers wi l l be collated by the Health Worker and/or volunteer at the health center. Similarly the feedback received from the health authorities by the health center w i l l be shared with the communities.

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Additional Annex 17: Environment Management Plan May 2003

INDIA: Integrated Disease Surveillance Project

1. Context

The Project would cover all States and Union Territories with surveillance uni ts up to Community Health Centres level. It i s hoped that this will result in an early diagnosis and reporting o f the target diseases and will also be able to detect early warning signals o f impending outbreaks and initiate an effective response in a timely manner.

The three main components o f the project are:

0

0

0 Improve laboratory support. 0

Establishment and Operation o f a Central-level Disease Surveillance Unit Integrate and strengthen disease surveillance at the state and district levels,

Training for disease surveillance and action.

The project envisages improving the diagnostic facilities in public health laboratories up to Community Health Centres. Augmentation o f environmental health and safety would be an integral part o f the Project. The diseases under surveillance include tuberculosis, malaria, AIDS, typhoid, cholera, polio, measles, leptospirosis, dengue, hepatitis, anthrax and plague and risk factors for non- communicable diseases including air and water pollution. The laboratories would handle biological samples such as blood, sputum, urine, stool and other human secretions. The laboratories would utilize routine equipment, instruments and standard chemicals.

The overall context for health care waste management (HCWM) i s given by the Bio-Medical Rules (prepared by MOEF in 1998 and amended in 2000). The Rules address both administrative issues and technical matters and are based on principles o f segregation o f “bio-medical waste” (defined in the Rules) produced in health care facilities, followed by adequately managed treatment and disposal to reduce adverse impact on public health and the environment.

2. Current situation

An international expert team undertook an baseline assessment o f the laboratory system in January 2002, o f 3 states (Tamil Nadu, Maharashtra and Uttar Pradesh), which included reviewing the waste management practices. This assessment indicated that there i s some awareness o f GO1 medical waste regulations among the laboratory staff at state, district or peripheral laboratories which needs to be enhanced. There i s need for strengthening biosafety in the laboratories and management o f laboratory waste. During project preparation and the baseline assessment, consultations were held with officials from national and state government departments, medical and research institutions and laboratories. The discussions revealed the need for each state to establish good laboratory procedures, occupational safety guidelines for laboratory operations and waste management guidelines along with systems for effective implementation and monitoring, to ensure compliance with GOI’s Biomedical Rules.

3. Key activities

The key activities to be carried out under the EMP are as follows: 1. Undertake a baseline assessment to review the health and safety and environmental practices and

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assess the quantum o f waste generated. (This wi l l build wherever possible on broader health care management and related activities, ongoing in a number o f states.)

2. laboratories.

Develop draft Standard Operating Procedures (SOPs) as guidelines for disease surveillance

3. Formulate a draft Waste Management (WM) Program for the dissemination o f the SOPs, awareness and training at laboratory levels, including the roles and responsibilities o f various parties, timetable and an estimate o f the costs (investment and operating) and sources o f funds for implementation. The initial program will be subject to refinement and adjustment in the initial stages o f implementation, taking into account the overall health care waste management system in each state.

4. 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.

Organize a national workshop to discuss the assessment findings and the draft SOPs and the WM

5. divided into modules appropriate for the different responsibilities and sk i l ls o f different groups, such as Medical Officers, laboratory personnel, technicians and cleaners. The training on WM practices wi l l be incorporated within related training being proposed under the project.

Design and implement a training program for the implementation o f the SOPs. The training wi l l be

6. appropriate. The provision o f basic equipment and infrastructure will be in accordance with the wider laboratory upgrading activities under the project and under a s imi lar timetable.

Support the implementation o f SOPs in the laboratories in the various states, in phases as

7. Establish an effective monitoring and reporting system.

4. Key Outputs

0 A Standard Operating Procedure for good practice management and mitigation measures for the various types o f wastes expected to be generated in laboratory operations and construction sites. (The MOHFW will develop Operational Manuals, one o f which i s for Laboratory Technicians, which will incorporate the SOP.) An implementation framework for introducing the appropriate SOP at various state levels, and 0

0 A monitoring framework.

5. Implementation

The Central Surveillance Unit at the MOHFW and District Surveillance Officers will be responsible for the overall project implementation and monitoring o f various components, including the EMP. Monitoring systems will also be put in place to ensure compliance with prescribed guidelines for waste management. The microbiologisflathologist, who would also be the officer in-charge o f the laboratory, will be responsible to ensure that laboratory personnel comply with prescribed guidelines for waste management. District Surveillance Officers will make periodic visits including surprise ones to ensure that the EMP activities are being implemented accurately. In addition, the Bank w i l l undertake regular supervision missions.

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6. Cost Estimates for the EMP

Renovation & Repair Costs Recurring Costs o f Laboratories

~ component

Waste management during civil works Consumables-plastic bags, buckets, disinfectants 20.22

12.18

1 Activities relating to Waste Management

Training Costs Information, Education &

Training in waste management 10.21 Public Awareness on waste management 18.00

Communication Monitoring & Evaluation Total on EMP

Monitoring & Evaluation o f waste management 2.50 63.1 1

7. Schedule of Implementation

Activities relating to Waste Management Conducting Baseline Waste Survey

Preparing operations manuals and training modules Conducting Training Procurement and Distribution o f consumables required

Yr 1 Y r 2 Yr3 Y r 4 Yr5 **

** ** **** **** **** **** **** **** ****

Civil Works at the Facility Level (1 st year o f 3 phases) Conducting evaluation by Independent Agency

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**** **** **** **** ****

Additional Annex 18: Strategy for involvement of Private Sector in Disease Surveillance INDIA: Integrated Disease Surveillance Project

At the All-India level in 1995, the private sector accounted for more than 80% o f ambulatory care, at least 60% o f hospitalizations and more than 40% o f ante- and post-natal care; and the market share o f the private sector has increased significantly in the last decade. Thus, a disease surveillance system which relies only on the public sector will yield a very incomplete picture o f disease patterns in the country. Further, if disease control activities are to be successful they also must take the private sector into account and ensure that private practitioners are aware o f and involved in achieving the priority health outcomes outlined by state and national authorities. l h s document outlines a strategy for involvement o f the private sector in disease surveillance and control activities. I t i s based on discussions with representatives o f the public and private sectors (especially the Indian Medical Association and the Indian Association o f Pediatrics) in various states in the course o f project preparation. In addition, consultants held extensive discussions in one state to assess the applicability o f a preliminary outline o f the strategy. Based on these discussions the strategy outlined here was developed; with appropriate modifications to accommodate differences between states, i t w i l l form the basis for involvement o f the private sector in disease surveillance and control activities under this project.

The elements o f the strategy are as follows:

1. Each state will develop partnership agreements with organizations representing private providers o f health care - in most states this will best be carried out through the Indian Medical Association (IMA) and the Indian Association o f Pediatrics (IAP). The formal expression o f these agreements will be through a Memorandum o f Understanding (MOU) between the state MOHFW and the IMA and IAP. A prototype MOU, which specifies the commitments o f both parties, for use by the states will be developed by the Central Surveillance Unit.

2. Involvement o f the private sector will be through private hospitals, private nursing homes and individual private providers/clinics. Each o f these facilities (hospitals, nursing homes or clinics) w i l l be regarded as a potential Sentinel Service Provider (SSP).

3. The State Surveillance Unit will estimate the number o f each type o f SSP to be included in the surveillance system in each district. In doing so the following criteria will be taken into account for each type o f facility - geographical coverage, the type o f patients usually seen, the number o f patients usually seen, coverage o f both outpatients and inpatients, the willingness o f the individual facilities to participate. In areas where there are no hospitals or nursing homes it will be necessary to use more individual providers and clinics, including RMPs. As there i s no experience to date in India o f involving SSPs in the disease surveillance system the ideal number o f SSPs per district i s not known. In discussions it was agreed that an initial targetUwould be 30 SSPs per 100,000 population in both rural and urban areas. (Each hospital sees a larger number o f outpatients than nursing homes which, in turn, usually see more at each facility than do individual providers or clinics. In rural areas there w i l l be more clinics and nursing homes and less hospitals. In urban areas there will be more hospitals and nursing homes.) Thus, the initial rules o f thumb for the number o f SSPs to be recruited differ between urban and rural areas and are:

0 Rural areas - 3 SSPs per block, most will be clinics and some nursing homes, there will be few hospitals. (At an average o f 15 blocks per district th is amounts to 45 SSPs per district; in a state wi th 30 districts this would give a total o f 1350 rural SSPs.) Urban areas - 25 nursing homes or hospitals per urban area. (In a state with 30 districts and 1 major urban area per district this would yield a total o f 750 urban SSPs.) Rural + Urban areas - in a state with 30 districts, a total o f 2100 SSPs.

0

0

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4. In each district the District Surveillance Unit (DSU) will develop a master l i s t o f private health providers using existing data bases from a variety o f sources such as those available with the Directorate o f Public Health, IMA, IM, drug companies and other special purpose surveys carried out by state governments and donors e.g. rapid assessment o f the private sector in 15 districts o f Tamil Nadu, a survey o f the private sector in all districts o f Orissa, a special purpose survey in Punjab, surveys planned for Kamataka and Kerala, the Institute o f Health Systems database in Andhra Pradesh. Where this information i s not available special purpose surveys will need to be conducted.

5. The DSU will finalize the l is t o f Sentinel Service Providers (SSPs) for each district based on willingness o f the providers to collaborate, using the master l i s t o f private facilities and in a manner to ensure geographic coverage, urban and rural representation, coverage o f outpatients and inpatients, and the type o f patients usually seen.

6. Reporting by each SSP will utilize forms provided by the DSU and will involve 0 Regular Weekly report; 0 Nil reports; 0

0

0

Simplified formats for reporting (see ‘Form B’ below); Agreement by each SSP with the DSU on the number o f conditions under surveillance; Agreement by each SSP with the DSU on the methods for transmission o f data to the district level - the aim i s to provide flexibility and the methods could include telephone, fax, electronic mailing direct to DSO, or courier.

7. In order to promote quality o f reporting by the private sector the D S U will ensure that all SSPs are provided with operations manuals and that SSPs undertake short training programs which are designed and scheduled to take into account the timing and workloads o f the SSPs. The training may be provided by the professional associations (e.g. IMA, IAP) themselves for their members with agreed supervision and evaluation. In addition, the DSU will be responsible for providing feedback to the SSPs on the results o f the surveillance system, the quality o f information they are providing and the ways in which quality can be improved.

8. The SSU and D S U will ensure that the participation o f SSPs i s sustained by providing appropriate feedback and incentives. W h i l s t it i s generally agreed that financial incentives cannot be provided, private providers indicate that their ongoing participation in the system would be enhanced if the S S U and DSU ensured that the names o f those participating were included in a network directory, they had representation on the District Surveillance Committee, certificates o f recognition and participation in the surveillance system were provided, training was coordinated with continuing medical education, and SSPs were provided regular bulletins and feedback on the functioning o f the system and on disease outbreaks and control.

9. The DSU will distribute to wider groups o f health providers in the formal and informal sector, pre-paid post cards for reporting unusual health events and changing trends o f disease. This will be done through sensitization meetings on IDSP (see training strategy) to increase broader private sector participation.

10. SSU and DSU will facilitate internal and external evaluations o f private sector participation in IDSP and that feed back provided to all stake holders o f the program.

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Form B

Dengue

1) These numbers are indicative only, will vary from state to state and district to district, and will be reviewed annually.

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Additional Annex 19 : Supervision Plan INDIA: Integrated Disease Surveillance Project

Given the size and scale o f this project, successful implementation will require constant attention to the schedule o f activities and ongoing efforts to ensure that the quality o f activities, as well as the scale, are at a level that allows the development and implementation objectives to be met. This will require consistent high quality inputs from the central and state governments and from the Bank. The Bank’s inputs will be through day to day interaction with government and through formal supervision missions, the schedule and indicative content for which i s outlined below.

The project will be implemented in three phases with new states entering the project in each o f the first three years. Thus, implementation assessment missions in these f i rst three years will be mainly concerned with two aspects - ensuring that the project i s being implemented in the states as scheduled; and that the surveillance system i s being implemented as described in the project design - t h i s will require attention to each o f the project components on each mission. In addition, there will also be a theme for particular attention on each mission (see the table below for indicative themes and routine activities to be assessed on each mission - further details for missions in the outer years will be added later and in response to details o f project implementation at the time). Where indicated, special surveys and assessments o f topics o f special interest will be commissioned prior to, or during, each mission.

The staffing o f each mission will be determined according to the themes o f the mission as well as the need for routine assessments. O n each mission, progress against the project indicators will be assessed and a summary o f progress and issues recorded in an Aide Memoire.

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lonths -om ffective- gg

-

Second mission

Implement a- tion mission First mission

mission) - as soon as possible after effectivenes

(Kick-Off

S.

mission

I

mission

0 Sixth mission

6 Seventh mission (Mid-Term Review)

Maior topics/themes to be covered

Theme: getting started. Schedule o f activities for the next year with particular emphasis on: procurement, training, financial management, quality assurance survey o f laboratoq information, software development, establishing all un i t s at central, state and district levels, identify selected districts in which project surveillance activities (including involvement o f the private sector) are to commence on a ‘pilot’ basis. Plans for preparation o f Phase 2 states. Selected state visits.

Theme: assess progress in implementing surveillance system in ‘pilot’ districts identified in previous mission, identify issues and problems and how they will be resolved, plans for extending activities to remaining districts in Phase 1 states, review software development. Routine assessment o f financial management, procurement, socia and environment, quality assurance survey. Progress on Preparation o f Phase 2 states. Selected state visits. Theme: use of surveillance information for improved use of data for action and for integrating disease control activities. Assess extent and quality o f activities in Phase 1 states and districts including performance on project indicators, review all manuals, readiness for commencing activities in Phase 2 states (including quality assurance surve: o f laboratory data). Results o f quality assurance survey o f laboratory data in Phase 1 states and plans for improving quality o f laboratory data, interim assessment o f software. connectivitv o f district in Phase 1 states. Selected state visits. Theme: activities in Phase 2 states - establish uni ts at state and district levels, plans foi quality assurance survey o f lab data in Phase 2 states, commence surveillance activities at district level, connectivity. software, training, procurement, financial management, plans for Phase 3 states. Selected state visits. Theme: use of data for action, routine assessment o f financial management, procurement, social and environment, quality assurance survey, assess private sector involvement, results o f quality assurance survey in Phase 2 states and plans for improving quality o f laboratory data, assess performance o f Phase 2 districts and states on project indicators and plans for improving system performance. Readiness for implementation in Phase 3 states, establish un i t s at state and district levels, commence surveillance activities at district level, quality assurance survey o f laboratory data. Selected state visits. Theme: activities in Phase 3 states - review un i t s at state and district levels, surveillance activities at district level, connectivity. software, training, procurement, financial management. Selected state visits. Theme: MTR and assessing the use of IT in the surveillance system, review overall implementation, connectivity, data collection and management; emphasis on software development and deployment, connectivity, training, use o f data for action; involvement o f private sector; procurement, financial management; social, environment; assess performance o f all states and districts (including Phase 3 districts and states) on project

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Eighth mission

Tenth mission

Eleventh mission

indicators and plans for improving system performance, results o f quality assurance survey in Phase 3 states and plans for improving quality o f laboratory data. Selected state visits. Theme: i s the system working and actions to improve system functioning follow-up tc MTR mission, routine assessment o f financial management, procurement, social and environment, quality assurance surveys. Selected state visits. Theme: i s the system working and actions to improve system functioning follow-up tc MTR mission, routine assessment o f financial management, procurement, social and environment, quality assurance survey. Selected state visits. Theme: sustaining the system beyond the project, routine assessment o f financial management, procurement, social and environment, quality assurance survey. Selected state visits. Theme: sustaining the system beyond the project, routine assessment o f financial management, procurement, social and environment, quality assurance survey. Selected state visits.

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