INTEGRATED SAFEGUARDS DATASHEET APPRAISAL STAGE I. Basic Information Date prepared/updated: 08/07/2012 Report No.: AC6748 1. Basic Project Data Original Project ID: P078539 Original Project Name: India: Second National Tuberculosis Control Project Country: India Project ID: P118832 Project Name: India: TB II Additional Financing Task Team Leader: Patrick M. Mullen Estimated Appraisal Date: Estimated Board Date: December 20, 2012 Managing Unit: SASHN Lending Instrument: Specific Investment Loan Sector: Health (70%);Central government administration (15%);Sub-national government administration (15%) Theme: Tuberculosis (60%);Health system performance (20%);HIV/AIDS (10%);Child health (10%) IBRD Amount (US$m.): 0 IDA Amount (US$m.): 100 GEF Amount (US$m.): 0 PCF Amount (US$m.): 0 Other financing amounts by source: BORROWER/RECIPIENT 100.00 100.00 Environmental Category: B - Partial Assessment Simplified Processing Simple [] Repeater [] Is this project processed under OP 8.50 (Emergency Recovery) Yes [ ] No [ ] or OP 8.00 (Rapid Response to Crises and Emergencies) 2. Project Objectives To improve diagnosis and treatment of both first-line and multi-drug resistant tuberculosis in both the public and private sectors. 3. Project Description An IDA credit (4228-IN) of US$ 170 million currently finances India's Second National Tuberculosis (TB) Control Program, approved in 2006 with a revised closing date of September 30, 2012. An additional IDA credit of US$ 100 million is proposed to contribute to the first two years of the TB control program's 2012-17 National Strategic Plan. The proposed additional financing will support implementation of modified, additional and expanded activities that would scale up the project's impact and development effectiveness. The Revised National Tuberculosis Control Program (RNTCP) has achieved success in expanding access to standardized diagnosis and treatment, exceeding globally-recognized targets. The proposed additional financing will contribute to the program's next phase with its new and ambitious objectives. Component 1 (Strengthening and expansion of diagnostic and treatment services for drug-sensitive and drug-resistant tuberculosis, US$ 71 million) will provide overall support to the TB program and its National Strategic Plan during its first two years (2012-13 and 2013-14), encompassing modified and expanded activities under the two original project components. Component 1 aims support service provision to over three million (cumulative) drug-sensitive and MDR-TB patients over the two year period. Component 2 (Development and start-up of new strategies, US$ 29 million) will support design and initial implementation of new strategies to expand the program's reach to new patients, including in the areas of public-private engagement, urban TB control, diagnostics, and information and communication technology (ICT). 4. Project Location and salient physical characteristics relevant to the safeguard analysis The project is implemented country-wide including a focus on clinically and socially vulnerable and hard to reach populations, especially the tribal and urban poor living in the slums. Bank OP 4.10 was triggered for the current project and a Tribal Action Plan was prepared and which has been implemented. 5. Environmental and Social Safeguards Specialists Ms Ruma Tavorath (SASDI) Mr Satya N. Mishra (SASDS) 6. Safeguard Policies Triggered Yes No Environmental Assessment (OP/BP 4.01) X Natural Habitats (OP/BP 4.04) X Forests (OP/BP 4.36) X Pest Management (OP 4.09) X Physical Cultural Resources (OP/BP 4.11) X Indigenous Peoples (OP/BP 4.10) X Involuntary Resettlement (OP/BP 4.12) X Safety of Dams (OP/BP 4.37) X Projects on International Waterways (OP/BP 7.50) X Projects in Disputed Areas (OP/BP 7.60) X II. Key Safeguard Policy Issues and Their Management A. Summary of Key Safeguard Issues 1. Describe any safeguard issues and impacts associated with the proposed project. Identify and describe any potential large scale, significant and/or irreversible impacts: Environment: Environmental and infection control issues associated with tuberculosis stem from clinical and infectious waste materials (primarily sharps including needles and slides and sputum cups) generated from service delivery and treatment centers. These issues are well defined, site-specific and easily mitigated if implemented in a systematic and sustained manner during service delivery activities. However, with inadequate attention and poor management, these issues can pose as a severe public health risk. Social: The project aims to support equitable provision of diagnosis and treatment services to all sections of the society while reaching out to marginalized and vulnerable groups, who are more vulnerable to the disease due to their health and socio-economic conditions and suffer maximum adverse consequences due to high costs of disease treatment and loss of work days. It is essential to address socio-economic, cultural and health system barriers that affect utilization of diagnostic and treatment services by these populations, including in poor/backward/tribal districts. It is necessary to establish strategies to address the needs and priorities of the clinically and socially vulnerable population groups affected by TB including tribal people and urban slum dwellers. OP 4.10 is triggered in view of the impact on tribal populations and accordingly a Tribal Action Plan was prepared and implemented with supplementary social inclusion measures for other vulnerable groups such as those affected by HIV/AIDS, urban slum dwellers, and others. The project does not involve any civil works and does not generate any involuntary resettlement impact. 2. Describe any potential indirect and/or long term impacts due to anticipated future activities in the project area: The project does not have any potential indirect and/or long term impacts due to anticipated future activities in the project. 3. Describe any project alternatives (if relevant) considered to help avoid or minimize adverse impacts. The project seeks to target clinically and socially vulnerable populations including the urban poor and the tribal groups affected by TB with the provision of early diagnostic and treatment services. The project does not have any adverse social or environmental impacts. 4. Describe measures taken by the borrower to address safeguard policy issues. Provide an assessment of borrower capacity to plan and implement the measures described. Environment: For the current project, the Central Tuberculosis Division (CTD) prepared and disclosed an Infection Management and Environmental Plan for RNTCP- II in 2004. During the lifetime of the project, a manual for laboratory technicians was updated, training modules were strengthened, and occupational good practices included in Standard Operating Procedures for RNTCP workers. Training activities were undertaken by CTD over the years and sample surveys found that the staff is generally well trained and knowledgeable of occupational and bio-safety procedures. While treatment and disposal of sputum cups and slides were being done as per the guidelines, there were instances of some facilities continuing the practice of burning chemically disinfected plastic sputum cups. Since the RNTCP is delivered through the general health system, end treatment and disposal of waste generated by RNTCP are integrated in the overall waste management practices of health facilities. Infection control and waste management practices are monitored on an ongoing basis during the half-yearly Joint and Common Review Missions across a sample of states. The Departments of Health and Family Welfare and National Rural Health Mission in several states have also undertaken independent evaluations of health care waste management knowledge and practices. During preparation of this additional financing phase, CTD has undertaken an assessment of a representative sample of 40 centres of varying sizes , including a laboratory across 10 districts in 5 states. The average volume of waste at these centres was 32-35 kg /day. Primary findings include that over 90 % of the staff have sound knowledge of infection control practices and have been trained. Only 65-70% of the centres have appropriate needle destroyers and adequate amounts of consumables. The findings of the sample assessment match those of earlier reviews, which have now been compiled and documented by the CTD. The recommendations focus on strengthening the guidance from state to districts regarding implementation and monitoring of healthcare waste management and improved budgetary allocation and proper disbursement for this activity. A generic action plan has been drawn up which will be disclosed by the client before negotiations. Social Assessment: Several efforts have been made under RNTCP to ensure equitable provision of services to all sections of the society while reaching out to the marginalized and vulnerable groups. Certain socio-economic, cultural and health system issues have however continued to affect full utilization of diagnostic and treatment services by these populations. A Social Assessment (SA) was undertaken in 2011 to understand how TB affects the vulnerable urban poor and tribal populations, as well as barriers to access and utilization of the program. The SA indicated high prevalence of TB amongst vulnerable people, and high economic costs and consequences of the disease; it explored multiple barriers, gaps and their inter-linkages affecting quality and outreach of the program. The socio-cultural, economic and health system barriers affecting fuller utilization of services include: (a) gap between traditional and biomedical knowledge causing delay in diagnosis and treatment initiation; (b) stigma, family and community support and the long path to care-seeking; (c) high costs of diagnostic tests, treatment and additional drugs; and costs related to transportation and nutrition supplements; (d) geographical barriers like location of facilities and difficult terrain in the hard to reach areas; (e) issues of health system services (shortage of physicians, health worker attitudes, lack of personal attention by clinical staff, "social distance" between patients and providers), service timings and quality of care (with regard to follow up, attention to side effects, counseling). Social Action Plan: Key actions recommended by the Social Assessment (SA) include: strengthening societal and family support systems, improving community awareness, reducing the economic burden on the patients and their families, and influencing providers' behavior and organization of health care services to make them more patient- friendly. These will complement the available biomedical interventions and assist in better utilization of TB control services in resource poor settings. The Social Action Plan prepared based on the SA findings includes steps such as : (i) increasing overall visibility of the program through community level (IEC, demand generation, helpline) strategies so that patients go directly to the health centre and do not depend on informal providers; (ii) introducing financial incentives to support patients and their families; ( iii) strengthening societal and family support systems through measures such as decentralization, widening choice of DOT provider, community DOT providers, and travel support to minimize financial and social cost of treatment; (iv) reducing stigma associated with the disease through one-way and two-way IEC activities; and (v) supplementing community level IEC strategy to provide information about TB and RNTCP. Tribal Action Plan: Institutional and implementation arrangements for RNTCP II have been designed to increase access to and utilization of treatment services by hard to reach populations. A Tribal Action Plan (TAP) was adopted as per the Bank OP 4.10 to improve people's access and treatment in tribal areas through (a) IEC strategy adapted to their social and cultural needs and settings, (b) community participation, and (c) enablers and incentives for public and private health care providers to work in tribal areas. For the next phase of RNTCP (2012-2017) which aims to achieve "early detection and treatment of at least 90 percent of estimated TB cases in the community," the Tribal Action Plan has been updated and shall be implemented with renewed focus in collaboration with the Integrated Tribal Development Administrations (ITDA). The Tribal Action Plan focused on: (a) strengthening early reporting, (b) enhancing treatment outcomes, and (iii) closer supervision of tribal areas. Specific steps included: increasing case detection and treatment success trends in a sample of pre-defined districts with higher proportion of tribal population; reducing default rates of female patients compared to male patients; promoting locally adapted IEC messages and patient education material in place; and having operational research results to assist in planning and implementation of RNTCP in the tribal pockets. Key achievements of the TAP are: (a) nutrition and social welfare schemes to support TB patients in some areas, (b) allowances to encourage key health staff working with RNTCP in tribal areas; (c) differential norms for establishing Designated Microscopy Centers (1 for 50,000); (d) travel allowances to patients and attendants; and (e) honorarium for patients completing the treatment as well as DOT providers. The TAP has been updated based on the SA findings to minimize access barriers, default cases, and improve treatment for the tribal populations. The updated TAP includes steps such as: (i) engaging more contractual staff from community, (ii) filling up staff vacancies in tribal districts, (iii) developing locally relevant IEC, (iv) promoting sputum transport through NGOs, providing travel allowance for patients and their attendants, (v) increasing CSO participation, and (vi) providing decentralized, patient friendly and flexible DOT services with improved human contact and community participation. 5. Identify the key stakeholders and describe the mechanisms for consultation and disclosure on safeguard policies, with an emphasis on potentially affected people. Social: The key stakeholders involved in project preparation and implementation include the state governments, public and private service providers and workers, NGOs, civil society groups and networks working on health issues, those representing the interests of vulnerable populations groups, state and district tribal administrations, and tribal communities and their local representatives. The TAP was prepared in consultation with the stakeholders, who are also consulted on a periodic basis for monitoring and review of the implementation process. Environment: At the National Level: National Rural Health Mission and all other programs under it, National Reference Laboratory, National Tuberculosis Institute, Technical Support Group (TSG). At the state level: NRHM, Hospitals, Intermediate Reference Laboratories, State AIDS Control Society, Public Private Interface Agency (PPIA). At the District level: Common treatment facilities (CTF), NGO, District Health Societies, District AIDS Prevention and Control Society (DAPCUs. B. Disclosure Requirements Date Environmental Assessment/Audit/Management Plan/Other: Was the document disclosed prior to appraisal? No Date of receipt by the Bank 07/26/2012 Date of "in-country" disclosure 08/10/2012 Date of submission to InfoShop 08/07/2012 For category A projects, date of distributing the Executive Summary of the EA to the Executive Directors Resettlement Action Plan/Framework/Policy Process: Was the document disclosed prior to appraisal? Date of receipt by the Bank Date of "in-country" disclosure Date of submission to InfoShop Indigenous Peoples Plan/Planning Framework: Was the document disclosed prior to appraisal? No Date of receipt by the Bank 07/09/2012 Date of "in-country" disclosure 08/10/2012 Date of submission to InfoShop 08/07/2012 Pest Management Plan: Was the document disclosed prior to appraisal? Date of receipt by the Bank Date of "in-country" disclosure Date of submission to InfoShop * If the project triggers the Pest Management and/or Physical Cultural Resources, the respective issues are to be addressed and disclosed as part of the Environmental Assessment/Audit/or EMP. If in-country disclosure of any of the above documents is not expected, please explain why: C. Compliance Monitoring Indicators at the Corporate Level (to be filled in when the ISDS is finalized by the project decision meeting) OP/BP/GP 4.01 - Environment Assessment Does the project require a stand-alone EA (including EMP) report? Yes If yes, then did the Regional Environment Unit or Sector Manager (SM) Yes review and approve the EA report? Are the cost and the accountabilities for the EMP incorporated in the Yes credit/loan? OP/BP 4.10 - Indigenous Peoples Has a separate Indigenous Peoples Plan/Planning Framework (as Yes appropriate) been prepared in consultation with affected Indigenous Peoples? If yes, then did the Regional unit responsible for safeguards or Sector Yes Manager review the plan? If the whole project is designed to benefit IP, has the design been reviewed Yes and approved by the Regional Social Development Unit or Sector Manager? The World Bank Policy on Disclosure of Information Have relevant safeguard policies documents been sent to the World Bank's No Infoshop? Have relevant documents been disclosed in-country in a public place in a No form and language that are understandable and accessible to project-affected groups and local NGOs? All Safeguard Policies Have satisfactory calendar, budget and clear institutional responsibilities Yes been prepared for the implementation of measures related to safeguard policies? Have costs related to safeguard policy measures been included in the project Yes cost? Does the Monitoring and Evaluation system of the project include the Yes monitoring of safeguard impacts and measures related to safeguard policies? Have satisfactory implementation arrangements been agreed with the Yes borrower and the same been adequately reflected in the project legal documents? D. Approvals Signed and submitted by: Name Date Task Team Leader: Mr Patrick M. Mullen 07/26/2012 Environmental Specialist: Ms Ruma Tavorath 07/26/2012 Social Development Specialist Mr Satya N. Mishra 07/26/2012 Additional Environmental and/or Social Development Specialist(s): Approved by: Regional Safeguards Coordinator: Mr Sanjay Srivastava 08/02/2012 Comments: Cleared.Please refer to the safeguards comments in the email of July 31, 2012 sent by SARDE. Sector Manager: Ms Julie McLaughlin 07/26/2012 Comments: Cleared