India - Cataract Blindness Control Project

Document of The World Bank FOR OFFICIAL USE ONLY C~ . J'~ -Lg / // Report No. 12246-IN STAFF APPRAISAL REPORT INDIA CATARACT BLINDNESS CONTROL PROJECT APRIL 21, 1994 MICROGRAPHICS Report No: 12246 I14 Type: SAR South Asia Country Department II (India) Population and Human Resources Operations Division "his document has a restdcted dstribution and may be used by recipients only in the perfonnance of their offieiud dulies Its contents ay not otewise be disdosed without World Bsnk authization.  CURRENCY EOUIVALENTS (As of May 1, 1993) Currency Unit = Rupee Rupee 32.60 = US$ 1.00 Rupee 1.0 = US$ 0.0307 METRIC EQUIVALENTS 1 Meter (m) = 3.28 Feet (ft) 1 Kilometer = 0.62 Miles FISCAL YEAR April 1 - March 31 ABBREVIATIONS AND ACRONYMS CHCs - Community Health Centers CMU - Central Mobile Units DANIDA - Danish International Development Agency DBCS - District Blindness Control Societies DMU - District Mobile Units DALYs - Disability Adjusted Life Years ECCE - Extracapsular Cataract Extraction ICCE - Intracapsular Cataract Extraction IOL - Intraocular Lens MOHFW - Ministry of Health and Family Welfare NPCB - National Program for the Control of Blindness NICNET - National Infonnatics Center Nationwide Network PHC - Primary Health Center RIO - Regional Institute of Ophthalmology SEC - State Empowered Conunittee WDR - World Development Report  FOR OFFICIAL USE ONLY DEFINITIONS Aphakia Absence of the crystalline lens from the eye. Aphakia occurs if the lens has been surgically removed, as in cataract surgery, or if it has been destroyed by a penetrating object. Aphakia causes severe loss of focusing in the affected eye or eyes and requires correction by lens implants, contact lenses or glasses. Blindness Visual acuity < 6/60 in both eyes. (See para. 2.11). Cataract Partial or complete opacification in the crystalline lens of one or both eyes. Cataract leads to progressive vision impairment and is the main cause of blindness in the world. Cataract, common to old age, can be treated by removing the opacified lens and wearing special glasses. [Cataract is derived from the Greek word, Katarraktes, or waterfall, because it was thought that the whiteness behind the pupil was a kind of waterfall descending from the brain fluids]. Couching Surgical displacement of the lens backward into the inner eye where it remains. This contrasts with .,cract surgery where the lens is removed from the eye. Couching is often performed by traditional healers. Post-operative infection is the main risk associated with this surgical procedure. Coverage A measure of the extent to which the services rendered cover the potential need for these services in a community. It is expressed as a proportion in which the numerator is the number of services rendered, and the denominator is the number of instances in which the service should have been rendered. DALYs Disability Adjusted Life Years. DALYs represent the sum of the years lost both from premature death and from disability associated with disease and injury. This documet mas a sricted distnrbuton and may be used by recipien only in the perfmae of ther lomaiduties. Its contes may not otwise be discled without World Ban authaion I  - ii - Epidemiology The study of the distribution and determinants of health-related states and events in populations, and the application of this study to the control of health problems. Extracapsular Cataract Extraction (ECCE) Cataract surgery performed by extracting lens material in small pieces while leaving the posterior lens capsule in place. Together with implantation of an intraocular lens (IOL) behind the iris, ECCE affords a greater level of visual rehabilitation than that possible with conventional surgery (ICCE) and results in fewer complications. This procedure requires provision of operating microscopes and microsurgical instruments, and specialized training for surgeons. Intracapsular Cataract Extraction (ICCE) Cataract surgery performed by removing the entire lens, including its surrounding capsule. This method requires the use of aphakic spectacles after surgery. This operation is relatively simple to perform and is most commonly used in developing countries. Intraocular Lens (IOL) A clear plastic lens implanted in the eye during ECCE surgery, which serves as a substitute for the natural lens of the eye. Use of an IOL is indicated for unilateral cataract cases. IOLs also eliminate dependence of cataract patients on aphakic spectacles. Incidence Number of new cases of a disease or condition over a period of time as a proportion of the population at risk at midpoint. Incidence means "new" and is a direct indicator of risk. Prevalence Number of cases of a disease or condition at a given point in time as a proportion of the total population. Prevalence means "all" and is used by health planners to assess workload and service delivery needs. Ultraviolet (UV) Light beyond the range of human vision.  CATARACT BLNDNESSCONTROL PROJECT ThAB 3F CONTENTS PAGE NO. CEDIT AND PROJECT SUMMARY ...... ............... vi I. DNTROUCTON National Health Policy ........................... 1 II. CATARACT BLINDNESS AND THE STfllUATION IN INDIA A. The Problem of Cataract Blindness in India .1 B. Epidemiological and Technical Background. 2 C. The National Blindness Control Program. 4 D. Major Issues in Blindness Control in India .5 E. External and Local Non-Governmental Assistance .10 F. Lessons of Experience ...................... 10 G. Country Assistance Strategy and Rationale for IDA Involvement ...................... 12 m. THE PROJECT A. Project Objectives ........ .............. .14 B. Project Strategy .......................... 14 C. Project Scope ............................ 14 D. New Policies, Pr e s and Standards .... ....... 15 E. Project Description ........................ 16 biis repont is based on an appaisal miion d visited bndi in June 1993. Ibe mission coniprised Marim Donoso Cla* (Senior Anthropologist and Mission Leader), Salim Habayeb (Senior Publ;c Health Specialist), Kevin Casy (Senior Ope wtos Officer), A. A. Conactor (Publc Health Specialist), Kaniz Siddiqui, and V. J. Ravisihankar (Economists). Ihe mission was assisted by Dr. Carl Kupfer, (Direr, Nadonal Eye Instite, NIH, Consltan); Dr. Leon Efiwein (Special Advisor to the Diror, Nations Eye Inst, NIH, Consutant), Dr. Paarinaeam (ophdiahmologist, WHO, Consultant), Girija Brilliant (IMC Consultant). Ihe peer reviewers are Dr. C. Kupfer (NIH), Dr. R. Paraaasegram (WHO, Geneva), Dr. 1. Javin, (Professor of Ophthalmology, Georgetown Undversity), Dr. D. Jamison (tATAD), Y. Genevier (AFARB) and S. Davis (EllISP). Tne Proect is endorsed by Richard Skolnik. Chief. Populadon and Human Resources Operations Division, and Heinz Vergin, Director, India Country DepartMnL  - iv - IV. PROGRAM COSTS. FINANCING AND IMPLEMENTATION A. Costs ......... .......................... 28 B. Financing Plan ........................... 29 C. Sustainability ........................... 30 D. Cost Effective-iess .......................... 33 E. Implementation .......................... 34 F. Monitoring ........................... 37 G. Disbursements ........................... 39 H. Procurement ........................... 40 I. Accounting and Auditing .42 V. BENEFITS AND RISKS A. Benefits .42 B. Risks ...... 44 VI. AGREEMENTS AND RECOMMENDATIONS .... ......... 45  v - PAGE NO TABLES 4.1 Cost By Component ........................................ 28 4.2 Cost By Categories of Expenditures ........................ .. 29 4.3 NPCB Expenditures .......................... 30 4.4 Procurement Arrangements ......... ................. 41 ANNEXES 1. Causes of Blindness in India .... ......................48 2. Prevalence of Blindness in the Seven Project States .49 3. ICCE: Intracapsular Cataract Extraction .50 4. ECCE/IOL: Extracapsular Cataract Extraction/Intraocular Lens .51 5. Cataract Surgery - Targets and Performance .52 6. Pattern of Expenditure by States on the National Program for the Control of Blindness .53 7. Expenditures Since 1985-86 on the National Program for the Control of Blindness In Constant 1992 Rs. (Million) .55 8. Partial List of Non-Governmental Organizations (NGOs) Involved in Blindness Control ............................ ................... 56 9. Projected Cataract Workload in the Seven States ................. . 57 10. Service Delivery Models .................. 58 11. List of Staff and Equipment Needed by Type of Service Delivery Facility .59 12. Technical Guidelines .60 13. Required Equipment for Conducting ECCE/IOL Surgeries .66 14. Guidelines for Selection of NGOs and Private Practitioners .68 15. Sumary Plan of Action in Tribal and Other Isolated Areas. 70 16. Tiie-Table for Training .72 17. Selection of Medical Colleges as Institutions for Faculty (Trainer) Training .73 18. Traming Program for Ophthalmologists .77 19. Trainig of Allied Personnel and Others in Ophtialmology .80 20. Mangement Training .83 21. Outreach and Information, Education and Communication (IEC) Strategy 85 22. Organizational Structure of the National Program for the Control of Blindness ... 86 23. Management Information Systems .94 24. Mechanism of Quality Control .95 25. Planned Operations Research .96 26. Expenditure Accounts by Years and Categories Procurement Arrangements. 98 27. Implementation Timetable .104 28. Multi-level Participatory Process in Project Development .112 29. Project Monitoring and Evaluation (Essential Benchmarks) .114 30. Data Collection .117 31. Supervision Plan .119 32. Forecast of Expenditures and Disbursements .122 33. Flow of Funds Chart .123 34. Selected Documents Available in the Project file .124  -vi - INDIA CATARACT BLINDNESS CONTROL PROJECT (REDIT AND PROJECT SUMMARY India, acting by its President lDenefciarkets: States of Uttar Pradesh, Madhya Pradesh, Andhra Pradesh, Rajasthan, Maharashtra, Tamil Nadu and Orissa SDR 85.3 million (US$117.8 million equivalent) Ilrms: Standard, with 35 years maturity. tLending Tenns: Government of India to the States of Uttar Pradesh, Madhya Pradesh, Andhra Pradcsh, Rajasthan, Maharashtra, Tamil Nadu and Orissa in accordance with standard arrangements for development assistance to States. ltionw : The objectives of the project are to upgrade the quality of cataract surgery, expand services to underprivileged sectors, and reduce the bacldog of untreated cataracts. India's efforts to address the cataract problem has been stymied by inadequate treatment capacity and by increasing numbers of new cases each year. The National Program for Control of Blindness (NPCB) has been unable to prevent the build-up of 20 million untread cases because of financial, managerial and technical constraints. The proposed project would help improve NPCB's quality of service and expand its treatment capacity by: (a) enhancig quality of care and expanding service deliverv through new strategies, policies, technical and operational norms; increased use of modern surgical techniques; and expanded coverage of rural and isolated populations with extensive NGO and private sector involvement; (b) developing human resources for eve care delivery by strengthening selected training institutions, upgrading the skills of ophthalmic and health personnel, and providing management training for Central, State and District project managers; (c) promotng outreach activities and public awareness by supporting NGOs and community involvement, and raising awareness about cataract blindness through mass and taditional folk media, and interpersonal communications; and (d) dveloping institutional capacit at the Central, State and District levels, developing collaborative mechanisms with the non- government sectors, introducing measurable monitoring mechanisms, and conducting operations research.  - vii - jendits: The project would help eliminate most of the cataract blindness backlog by bringing the blindness prevalence down by 50% in the seven project states. More than 11 million surgeries woult be done over seven years. It is estimated that an effective cataract program in India would save about 2.4 million Disability Adjusted Life Years (DALYs) annually, and more than US$357 million in lost wages and injury-related health care expenditures over the seven years of the project. The project would greatly improve the quality of eye care, build local capacity and promote private sector development. It would also reduce the burden of caring for the blind, increase the quality of life of the individual and give access to services to the most disadvantaged groups, namely rural women, and scheduled tribes and castes who iend to have higher prevalence than the rest of the population for lack of access to ophthalmic services. It is estimated that more than 50% of the beneficiaries and almost all care-givers of the blind are women. Biwa: The project would entail several risks because of t'he major shifts required in program policies and strategies, the logistical requirements associated with reaching remote areas, the diverse administrative capacity of each of the seven states, the important role expected of the ophthalmic and NGO communities, the possibility of poor visual outcomes expected under any type of surgical intervention for a small percentage of treated patients, and the expansion of a technology that until now has been restricted to tertiary-level facilities or private practices and available mostly to those who can pay. These risks should be offset by the detailed and participatory process followed during preparation, the appropriate phasing of project inputs, the checks and balances introduced in the project design including the concept of "full disclosure" and "informed consent," and the up- fronit agreement by GOI and the concerned States to the policies, processes and norms developed with government and state officials, Indian ophthalmologists and NGOs. The project would create an enabling environment for greater private sector involvement and build institutional capacity, which should also help reduce these risks.  - viii - Estimated Program Cost: /a Locai ForX Toa Us$ Mmio- Strengthening Service Delivery 98.7 20.0 118.7 Developing Human. Resources for Eye Care 3.3 1.7 5.0 Promoting Outreach & Public Awareness 7.6 2.4 10.0 Developing Institutional Capacity 73 0.7 TOTAL BASE COST 117.0 24.8 141.7 Contingencies -2.4 5.4 3.1 TOTAL PROGRAM COST 114.6 30.2 IlA /b /a Including Taxes and Duties equivalent to US$4.7 million. /b Figures shown are the costs of the Enhanced NPCB in the seven states plus the national program costs and are used as the basis for calculating the incremental project cost of US$ 135.7 million. See also table 4.3 in the SAR for explanation of this calculation. US$ Millon Government 17.9 - 17.9 IDA 87.6 30.2 117.8 TOTAL PROJECT COSTS 1035.4 02 Estimated Disbursements. IDA FY FY95 Y96 F97 Y EY Y99 FYOIO FYO1FYQ2 Annual 7.7 13.2 18.3 18.0 18.7 17.8 18.1 6.0 Cumulative 7.7 20.9 39.2 57.2 75.9 93.7 111.8 117.8 Economic Rate of Ret: Not Applicable Poverty Categorg: Program of Targeted Imerventio1i. One of the project's main objectives is to expand service delivery to poor and underserved areas ard to improve access to cataract surgery for tribal populations and women. The project cotins specific strategies for delivering services to these two groups.  INDIA CATARACT BLINDNESS CONTROL PROJECT 1. INTRODUCTION National Health Poliey 1.1 India's current National Health Policy gives high priority to fertility control, infectious and endemic diseases of public health significance. such as tuberculosis, malaria, and blindness; and preventable causes of maternal and child mortality and morbidity. The National Health Policy includes quantified targets for the 1990s and the year 2000 under a pkogram called "Health for All by 2000," which aims at the elimination of leprosy as a public health problem and the reduction of blindness prevalence from 1.3 to 0.3 per 1000 by the year 2000. However, current achievements in all areas already lag behind these targets except for childhood immunization. In the case of blindness, the result has been an accumulated backlog of untreated cataracts that has raised the prevalence of blindness in India to one of the highest in the world. In an effort to strengthen the social sectors to mitigate the effects of adjustment, the Government of India (GOI), supported by IDA's Social Safety Net Sector Adjustment Project (Cr. 2448-IN) is giving emphas is to the endemic disease programs, including the National Program for Control of Blindness. 1.2 The proposed blindness control project would help advance India's health agenda and meet the long-term goal of providing eye care delivery at low cost. The project would be fully consistent with the Govermnent's stated objectives of improving the delivery of health and family welfare services to rural communities and strengthening the health system's efficiency and effectiveness. It would also support GOI's policies and objectives for major disease control, which include use of appropriate technology, enforcement of appropriate standards of care, quality enhancement of service delivery through increased emphasis on training, retraining, and non-salary inputs, mobilizing NGOs and the private sector, and strengthening the role of the states and districts in program planning and implementation. H. CATARACT BLINDNESS IN INDIA A. The Dimension of the Blindness Problem 2.1 About 13 million Indians suffer from bilateral blindness; more than one- third of the world's total blind population of 35 million. Roughly 80%, or more than 10 million of India's blind population is the result of cataract, compared to 50% worldwide. Another 10 million Indians suffer from unilateral, or one eye cataract blindness. Other causes of blindness in India include uncorrected refractive errors, glaucoma, corneal opacity, trachoma, and vitamin A deficiency (Awnex 1). Blindness prevalence varies by geographical location, gender and degree of urbanization. Prevalence is higher among women, 1.6% compared to 1.4% for men; and in rural areas, 1.59% compared to 1.01% in urban areas. Annex 2 shows the prevalence in the selected project states which are among the 10 States and Union Territories with the highest prevalence of blindness.  - 2 - 2.2 The economic and social costs associated with blindness are especially high in India because of its high prevalence and the early-age onset of cataract which affects economically active individuals. In 1990, it was estimated that 2.4 million Disability Adjusted Life Years (DALYs)l are lost annually to cataract blindness. Almost half of these lost years are to individuals who otherwise would be economically active. Forty- five percent (45%) of cataract cases are under the age of 60; globally, most individuals develop cataracts after tbe age of 60. A possible explanation for India's early onset of cataract may be an excesive exposure to ultraviolet rays and inadequate nutrition. 2.3 India's attempt to lower its prevalence of cataract blindness has been stymied by inadequate treatment capacity and by an increasing number of cases. With a backlog of 20 million people with cataracts, 10 million of them bilaterally blind, and with the ability to perform a maximum of 1.5 cataract operations annually, many of them with unsatisfactory results, India faces a major obstacle in its fight against blindness. Moreover, the backlog increases each year. Using World Health Organization (WHO) appro,ximate estimates, India adds 1.4 million new bilateral cataract blind cases each year, and 2.5 million new unilateral cases. Between 1990 and 2025, with the over-65 population projected to grow from 37 million to 102 million, the annual incidence of cataract cases would almost triple. 2.4 The only way to stem this tide is to increase treatment capacity in the high prevalence states. Seven such states-Maharashtra, Rajasthan, Uttar Pradesh, Andhra P adesh, Madhya Pradesh, Orissa, and Tamil Nadu-have beer selected for the project; they account for 70% of cataract blindness in India. It is estirnated that over 11 million surgeries will be needed in the project states over the next seven years to address the backlog problem, advance India's goal to reduce the prevalence to 0.3%, and prepare the country for the expanded demand of an aging population. A major factor in achieving these goals would be to expand coverage, and improve the quality of surgical outcomes to increase service demand. B. Enidemioloical and Technical Backound 2.5 Cataract, an opacity in the normally clear, crystalline lens of the eye, is usually caused by chemical changes in the lens resulting in loss or reduction of vision. There are different types of cataract (congenital, juvenile, senile, cortical or nuclear), but only cataract blindness related to aging (senile cataract) is considered a public health problem. 2.6 About 90% of examined individuals over age 65 show signs of cataract. Senile cataract may show no symptoms and be discovered only on routine examination; however, a gradual, painless decrease in vision over a period of months or years, usually involving blurred vision and sensitivity to light, is a common symptom. When cataracts develop, they usually affect both eyes, but rarely at the same rate. I DALYs (Disability-Adjusted Life Years) represent the suin of the years lost both from premaure death and from dizability associated with disease and injury.  2.7 The actual causes of cataract are still unknown; therefore no preventive treatment has yet been found. Studies point to several risk factors such as malnutrition or a diet poor in vitamins C and E, smoking, moderate to heavy alcohol consumption, severe attacks of diarrhoea, and excessive exposure to the sun's ultraviolet rays, but until now there are no conclusive findings. Cataract may also result from disorders during pregnancy, eye infections, medications, exposure to radiation, or eye injuty and therefore affect children and young adults. Glaucoma, diabetes or metabolic disorders may also increase the risk of cataract. 2.8 Although cataract cannot be prevented, it can be cured. The clouded lens can be removed surgically in a procedure that takes five to twenty minutes depending on the technique used. Cataract surgery is highly successful and over 90% of patients in the developed world regain useful vision. Success rates are less encouraging in the developing world due to complications resulting from infection, operations on unhealthy eyes, lack of refraction glasses, and use of inappropriate surgical technique for unilateral cases. 2.9 Sight reswration in cataract cases involves two steps: a surgical removal of the lens, and the correction of the resulting refractive error. Two surgical techniques are used: Intracapsular Cataract Extraction (ICCE) and Extracapsular Cataract Extraction (ECCE). The standard ICCE technique involves removing the clouded lens including the entire capsular membrane that holds it (Annex 3). Sight in the aphakic eye (eye without the natural lens) is restored through spectacles to focus light on the retina. The safety, speed, and simplicity of ICCE under local anesthesia has been the preferred technique for mass intervention programs for senile cataracts; however, ICCE/spectacles surgerj is suitable only for bilaterally blind cases. When individuals blinded by cataract in one eye undergo ICCE surgery, double vision results from the difference between the magnified image as seen by the operated eye with spectacles and the image seen by the normal eye. 2.10 Extracapsular cataract extraction (ECCE) accompanied by implantation of ntraocular lens (IOL)-an artificial lens made of clear surgical plastic-has almost entirely replaced the ICCE procedure in the developed world. In this more sophisticated surgical procedure, the lens is removed leaving the capsule bag intact. The IOL is inserted in the cleaned-out capsule and connected by loops that are part of the IOL structure (Annex 4). This procedure, although technically and medically more desirable, is more time- consuming than ICCE, requires increased surgical skill, microsurgical medical instruments, intraocular lenses and other supplies. Although ICCE and ECCE may be appropriate interventions for bilateral cataract blindness, depending on the availability of resources and skills, only ECCE with IOL should be prescribed for unilateral cases to avoid double vision. 2.11 Depending on the level of visual impairment, individuals may be considered socially blind or economically blind. The socially blind (vision S 3/60) are individuals whose level of visual impairment requires that an object, which can be recognized at a distance of 60 meters by a normal eye, be brought to a distance of 3 meters. The economically blind (vision < 6/60) are those whose vision requires that an object oe brought to a distce of 6 meters when a normal eye could see it at a 60 meter distance.  - 4 - The latter is the definition used by India in reporting data on blindness. Functional blindness standards in the U.S. relating to eligibility for benefits generally define blindness also as less than or equal to 6/60. These distinctions are important for diagnostic purposes and because estimates of the number of blind vary depending on the definition used. 2.12 The Bank's study on Health Priorities and the 1993 World Development Report (WDR) identified cataract blindness as an important health priority for developing countries. If left untreated, cataract blindness results in a signifi-ant public health problem because it affects the economic productivity and the quality of life of the aff'xted individual. It also imposes a burden on others as a blind person becomes increasingly dependent on family members for economic support and assistance in day to day activities and a burden on the health system for treatment of injuries associated with blindness. C. The National Blindness Control Progam 2.13 Background. The first organized national effort to control blindness in India was the National Program for Tra.homa launched in 1963. Twelve years later, when the Indian Council of Medical Research Survey revealed that cataract was the major cause of blindness in India, the national program changed focus and was renamed the National Program for Prevention of Visual Impairment and Control of Blindness. The new strategy emphasized health education, mobile health care through eye camps, and development of permanent infrastructure for community-oriented eye care. In 1976, the National Program for Control of Blindness (NPCB) was formally launched and included in the Prime Minister's 20 Point Development Program. 2.14 Program Objectives. The NPCB aims to provide comprehensive eye care at the primary, secondary and tertiary levels including treatment for all eye diseases, such as cataracts, conjunctivitis, vitamin A deficiency, ocular injury, corneal diseases, and glaucoma, and correct refractive errors. It promotes eye health nationwide through health education activities in communities and through school visits where children are screened for eye diseases, provided with vitamin A supplements, and taught about proper eye care. 2.15 Organizational Structure. The NPCB is 100% centra;ly-sponsored. It is managed through two separate units at the Ministry of Health & Family Welfare (MOHFW), a Central Ophthalmic Cell under the Director General of Health Services and an Administrative Unit under a Joint Secretary. At the state level there is a State Coordination Committee and a State Ophthalmic Cell which oversee resource allocation and compliance with performance targets under the supervision of the Ministry of Health and Family Welfare. Until recently, there was no organizational structure at the district level. District Blindness Control Societies have been created within the past year to implement the program at the district level. 2.16 Program imnplementation. Service delivery is offered at both fixed health facilities and through mobile units. At the district level, ophthalmologists are stationed at ophthalmic units of the district hospitals. At the local level, ophthalmic assistants  - 5 - (OAs) are to be placed at Community Health Centers (CHCs) and Primary Health Centers (PHCs). Many of the posts approved, however, remain vacant. 2.17 In remote areas, the main service delivery strategy is through eye camps. Central mobile units (CMUs) attached to medical colleges and district mobile units (DMUs) located in district headquarters are expected to perform outreach activities and operations, and to provide general eye care in remote areas. However, only half of the DMUs needed have been allocated and many of them are in poor operating conditions. 2.18 Difficult cases are to be referred to the Medical Colleges' Departments of Ophthalmology which also train medical and paramedical personnel and conduct ophthalmic research. Thirty seven (37) training centers for ophthalmic assistants have been established and nine Regional Institutes of Ophthalmology (RIOs) have been created with the expectation of becoming regional centers of excellence. Technical guidance is provided to all institutions by the Rajendra Prasad Center for Ophthalmic Sciences (RPC) at the All India Institute of Medical Sciences in New Delhi. 2.19 Target figures for cataract operations to be performed in each state are established yearly to monitor program performance. These targets are set at the central level based on the state's estimated backlog, infrastructure facilities, and previous performance, but often target allocations are arbitrary for lack of adequate information. State performance in meeting these targets varies greatly. Target figures remained roughly constant in 1987-1989, increased slightly in 1989-91, and increased considerably in 1991-92. However, increases in target numbers have led to a decrease in the percentage of target achievements because capacity for setvice delivery and management has not been strengthened to correspond to target increases (Annex 5). 2.20 Despite NPCB's efforts to emphasize community-oriented eye care services and reduce the cataract backlog, the program is not meeting its objectives for a variety of reasons (see paras. 2.21 - 2.42). The program suffers from inadequate organizational structures, poor technical standards, lack of properly trained ophthalmologists, limited fmancial support, and poor resource allocation at the community level, with tertiary facilities and salaries absorbing over 75 % of ophthalmic expenditures in the states. As a result, treatment capacity is inadequate, surgical outcomes are deficient and many cataract victims are unaware that cataract blindness can be cured. D. Major Issues in Blindness Control in India 2.21 The following program constraints have curtailed the effectiveness of the NPCB and are expected to be addressed by the proposed intervention. Policy and Stratey Issues 2.22 Lack of Strategic Program Mana,ement. Program administration has been limited to allocating resources, providing some technical advice, setting targets and monitoring target achievement without strategic planning or monitoring systems to measure appropriate resource allocation and performance.  -6 - 2.23 Fragmented Efforts by the Private. Voluntary and Public Sectors. The NPCB has been unable to establish a coherent strategy to coordinate the efforts of the private, voluntary and public sectors involved in blindness control in India; as a result, coverage has been insufficient and erratic. Urban areas are generally well served by all three sectors, but most rural areas, particularly the tribal ones, depend solelv on the public sector and receive uneven and infrequent services, or no service at atl. Voluntary agencies--at times with government involvement-have carried out the bulk of cataract surgeries in some states, but this coverage is selective and inefficient, and cases continue to accumulate in rural areas. 2.24 The challenge for the NPCB is to create an enabling environment for the private, voluntary and public sectors to work in a complementary fashion; for example, the public sector would need to make infrastructure available in the rural and remote areas for use by voluntary and private practitioners. Such an approach would avoid redundancy of efforts, increase coverage, access and quality of services, and benefit from economies of scale. In areas where the voluntary sector plays a strong role, the public sector would play a more limited role in service delivery. Where the voluntary sector is weak or non-existent, the government would need to ensure adequate provision of services and encourage future involvement of the voluntaiy and private sector. 2.25 Emphasis on Ouantity over Ouality. NPCB has focused primarily on increasing the number of cataract operations without assessing the quality of outcomes or patient satisfaction. To meet numerical targets, most unilateral cases are being operated on with the traditional ICCE technique which is medically inadvisable and leads to patient dissatisfaction, as noted earlier. In addition, by counting these unilateral cases, performance has been overstated because sight restoration is not achieved and blindness prevalence is not reduced. A study of eye camp surgeries conducted between 1980-89 showed that over 45% of treated cases had been operated on with traditional ICCE technique. To reach the project objectives of sight restoration, the NPCB will need to shift its emphasis from purely numerical targets to measuring outcomes as well. Financial Constraints 2.26 From 1985 to 1992, total expenditure on blindness control in India as reported by NPCB, ranged from 85 to 100 million rupees (US$3 million) each year. From 1985 to 1991, the Central Government's expenditure on blindness control decreased each year, declining from 85 million rupees in 1985 to 59 million rupees in 1991. During this period the states contributed an increasing amount of money from their own budgets to compensate for the lack of Central fundinge and to be able to meet their targets. Annex 6 shows the 5-year average expenditure by the states in cataract blindness. In 1991-92, the amount released by the Government of hIdia increased over 2 As the states do not have separate accounting procedures for ophthalmic units, it is difficult to report precise state expenditures. The figures discussed here and presented in Annex 6 represent the best available estimates of state expenditures on the NPCB. These figures do not include additional state expenditures on various ophthalmic units located in the medical college hospitals, specialized hospitals, and district hospitals.  - 7 - 50 percent to 97 million rupees; this amnount covered almost the entire nationwide expenditure as the states reduced substantially their contribution to the program allowing them to make reallocations to other health priorities (Annex 7). 2.27 Budgetary allocations for cataract treatment have been inadequate to make significant headway in reducing cataract blindness prevalence, particularly in the rural areas. The states have generally emphasized expanding infrastructure rather than improving effectiveness and efficiency of existing facilities. In addition, a gap exists each year between the amount sanctioned and the amount released to the states by the Center. In 1991-92, 124 million rupees were sanctioned by the Center, but only 97 million rupees were released. A delayed release of funds caused by bureaucratic inefficiencies leaves insufficient time for the states to incur expenditures from the NPCB; and once funds reach the state level, they are often diverted to other activities, particularly tertiary care, or are earmarked in such a way that the states are prevented from using funds for critical blindness control expenditures. To overcome these obstacles, a flow of funds directly to the district level would be needed to give some financial autonomy to the District Societies to facilitate implementation. Technical Issues 2.28 Deficiencies in the Cycle of Care. Poor quality outcomes are often the result of inadequate diagnosis, inappropriate surgical procedures and lack of patient follow up. As noted earlier, India continues to operate unilateral cases with traditional ICCE technique, mostly among the poor. While ICCE technique is perfectly suitable for bilateral cases, given the conditions available in developing countries, competent screening and appropriate selection of surgical techniques are critical for achieving visual restoration. This is often not achieved due to lack of adequate diagnostic training, limited availability of ECCE/IOL surgical skills, and inadequate post-surgical follow-up. 2.29 India's capacity to provide high quality care including ECCE/IOL surgery must be expanded through proper training of surgeons and ophthalmic personnel, adequate provision of materials, and higher standards of care. As the backlog of cataract blind patients decreases, a higher percentage of individuals requiring surgery will be unilaterally blind, making the expansion of ECCE/IOL capacity a critical factor in preparing India for the future. 2.30 Excessive reliance on camps in improvised facilities. India relies heavilv on eye camps to reach rural populations. Improvised camps are widely used for several reasons. First, there is an inadequate availability of facilities in sub-district hospitals or Community Health Centers. Second, patients are more willing to seek treatment when they are part of a group. Camps have a festive and communal atmosphere, are less intimidating and costly than hospitals, and are more accessible. Third, camp organizers gain social prestige and, for many, restoring eye sight has a religious value. Fourth, restoring sight is seen by many as charity rather than a health service and therefore in many instances, the quality of care is unwittingly compromised. And fifth, surgeons are more readily available for sporadic camp services than for permanent assignments in rural areas. 2.31 There are good reasons for continuing with the camp approach and the traditional ICCE technique, particularly during the transition period; however, the  - 8 - emphasis must be on camps in fixed medical facilities, rather than in improvised facilities such as schools. This would help maintain the positive features of the camp while ensuring quality control and follow up care. Because camps are organized in ad-hoc manner. patient follow-up depends largely on the willingness of the individual to return for a check up thus increasing the risk for poor visual outcomes. 2.32 To overcome these constraints, the NPCB will need to modify its service delivery strategy, adopt new technical standards, ensure adequate training of ophthalmic personnel, provide the required inputs, and educate the patients about eye care. Organizational and Mfanagerial Issues 2.33 Division of Authority at the Center. A limiting factor for the NPCB has been the lack of integration and cohesion in the organizational structure of the program. As indicated in para. 2.15, NPCB management has been split between two MOHFW units, one technical and one administrative, with different reporting relationships. The Assistant Director General (Ophthalmology) is responsible for the technical aspects of the program in the Directorate General of Health Services (DGHS) The Joint Secretary (Health Services) in MOHFW is in charge of the administrative functions, including policy, planning and project management. As a result of this organizational dichotomy at the center and the weak managerial set up in the states, communication at the different levels is fragmented and service delivery efforts are irregular. A consolidated organizational unit at the Center and State levels responsible for all aspects of project management, including appropriate technical support, would greatly increase efficiency and effectiveness. 2.34 Incomplete Organizational Structures. The program has made significant progress, despite its limited resources, in developing basic infrastructure and allocating staff. However, the NPCB's ultimate objective to provide eye care services in the periphery has been hampered, in part, by the lack of an organizational structure at the district level. Prior to the preparation of this project, only a few districts had established District Coordination Committees. As a result, decisions have been overly centralized and made on the basis of perceived needs with little infusion of information from the working level. Reporting relationships are tenuous and distant, and commr,unication among the staff working on the program is limited. Allocation of staff and organization of camps are opportunistic, and bureaucratic bottlenecks make it difficult for inputs and equipment to reach health posts at the community level, leaving isolated and tribal areas severely underserved. 2.35 Establishing District organizations with a degree of financial autonomy, clear lines of accountability and reporting relationships under a common managerial and administrative framework would allow the program to improve effectiveness, expand coverage, increase reliability, and improve the quality of services. 2.36 Underutilization of Existing Facilities. Despite the investments in infrastructure, equipment and manpower, many facilities remain underutilized for lack of materials and supplies required for service delivery. When surgeons are available, they compete with surgeons in other specialties for use of operating theaters. The few  - 9 - dedicated eye care beds are often used for other purposes and non-working mobile units keep the ophthalmic assistants and surgeons idle. 2.37 The NPCB will need to clhange its approach in allocating resources to ensure that "complete service delivery packages" for essential care are in place. Critical equipment must be placed under a strict schedule of preventive maintenance, and spare parts must be available to keep equipment functional. Human Resources Issues 2.38 Concentration of Ophthalmologists in Urban Areas. Two thirds of the nation's ophthalmologists wurk in the private sector with a few working in remote areas. Efforts to place ophthalmologists in rural areas have been problematic. Inadequate living accommodations, lack of educational and professional opportunities and higher health risks are major disincentives. Many ophthalmologists in the government service are assigned non-ophthalmic functions, reducing the availability of trained personnel to work in rural areas. A strategy is needed to ensure that services are provided regularly by relying more heavily on Ophthalmic Assistants for non-surgical eye care, using ophthalmologists in an intermittent but systematic way, improving referral and patient transportation, and providing appropriate living accommodations for government surgeons and their families, when necessary. 2.39 Limited Onhthalmic Training. Indian ophthalmologists are trained primarily in conventional ICCE sutiery techniques. While an increasing number of Medical Colleges offer training in ECCE/IOL, the quality of the training in both techniques is compromised by insufficient equipment for "hands-on" surgical training, lack of systematic and rigorous certification standards, and limited or non-existent practical training. Refresher courses and in-service training for ophthalmologists and other ophthalmic personnel are scarce. To improve the quality of service, the NPCB will need to support improvement of existing training facilities, the technical and teaching skills of the trainers, and the content, quality and frequency of training of ophthalmic personnel, including changes in the medical curriculum for ophthalmo.ogy. Socio-cultural. Logistical and Financial Issues for Potential Beneficiaries 2.40 Among rural populations, folk beliefs and practices play an important role in decisions to seek treatment. A .recent study found that about 40 % of those suffering from cataract blindness do not seek surgery for various social, cultural and psychological reasons such as fear of surgery, hospitals or travel, poor quality outcomes among relatives or neighbors, family obstacles, fatalistic beliefs, and reliance on outdated practices such as "couching," and folk medicine. Many individuals consider blindness a natural condition of life, predestined by supernatural forces and therefore irreversible. There is also a widespread belief that treatment is possible only in the winter months. 2.41 The same study found that about 60% of those aware of surgical treatment did not seek surgery because of logistical and economic constraints. Geographical isolation limits access to facilities posing a serious problem for women without sons who, often can not find an escort. Other major obstacles include: transportation costs, loss  - 10- of wages as a result of accompanying family members for surgery, unauthorized fees at service facilities and other related expenses. 2.42 A significant challenge for the NPCB will be to create the appropriate outreach and public awareness programs to help overcome these obstacles. It is necessary that outreach activities rely heavily on community participation and NGO involvement. Account must be taken of the difficulties of reaching isolated areas in plamning and compensating NGOs for such services or providing transportation for the patients. Tailor made messages and approaches to reach tribal populations need to be developed. E. External and Local Non-governmental Assistance to NPCB 2.43 Cataract blindness has been a priority of many local and foreign NGOs providing support to the NPCB through outreach activities and surgical eye services throughout India. A partial list of NGOs involved in blindness is included in Annex 8. The Danish Development Assistance Agency (DANIDA) is presently undertaking pilot projects in 5 districts in different states and assisting in the development of the NPCB, and WHO has provided technical assistance to the project. Additional assistance has come also through Indo-UK collaboration. 2.44 NGOs have substantially supplemented the Government's outreach and treatment efforts by developing and implementing a multi-pronged approach using printed materials or other media, public lectures and community-based education activities, and conducting surgical camps. Valuable operational experience has been acquired through the work of these international and local agencies, and innovative community-based approaches for outreach and service delivery have been developed. The project would tap into existing arrangements with NGOs and promote new ones to expand the coverage and intensify the output and quality of surgeries. F. Lessons of ExDerience 2.45 Considerable experience with cataract blindness control has been accumulated through "Cataract-free-zone projects" throughout the developing world as well as from donors such as DANIDA, WHO and mnmerous NGOs. Following are the major findings from these experiences: 2.46 Benefit of ECCEAOL onerations. Experience in the developed world shows that the technique of ECCE su:gery, with the implantation of an IOL behind the iris, affords a level of visual rehabilitation that surpasses that achieved with traditional ICCE technique and use of spectacles. As ECCE requires the provision of operating microscopes and microsurgical instruments as well as surgeons trained in this procedure, it is not always possible to provide ECCE operations in a camp setting or to all patients. Given these requirements, the use of ICCE for bilateral cataract cases is appropriate; however, for unilateral cases, for whom treatment with ICCE results in fusion problems, and for patients whose jobs require precise eyesight, ECCE/1OL operations must be performed.  - I1 - 2.47 Vision is not restored in a significant number of cases. Pre and postoperative visual acuity data from other developed countries show that a significant number of patients do not recover vision after surgery for a variety of reasons such as: (a) the presence of blinding conditions other than cataract that go undetected until after surgery, (b) many aphakics do not wear prescribed spectacles due to breakage, loss of glasses, and fusion problems in unilaterally blind cases, and (c) many of these cases, if not operated with ECCE/IOL may not be better off than prior to surgery; resulting in dissatisfied clients who often demotivate others in the community. To minimize these issues, patients must be properly screened for surgery to detect any other blinding conditions and recommend the appropriate surgical technique. For those undergoing ICCE surgery, adequate provisions are needed to facilitate access to spectacles. 2.48 Decision on cataract surgery must be based on the patients' functional needs. The high rate of cataract surgery, the normal risks involved with any surgical procedure and the associated medical costs in developed nations, especially the U.S., has prompted a recent comprehensive review of current practice in recommending cataract surgery. New guidelines issued in the U.S. advocate that cataract surgery should be delayed as much as possible unless vision is severely impaired. Surgeons should rely heavily on the subjective feeling of the individual in determining whether surgery is indicated in otherwise healthy people. It is generally agreed that a reduced visual function that interferes with the everyday activities of the patient must be paramount in determining whether cataract surgery is indicated. 2.49 Need to shorten oosto erative stas. Reducing the length of the postoperative stay has been successful throughout the world, most notably in developed countries where cataract surgery is often an outpatient procedure. A shorter stay promotes cost contaimnent, improves efficiency and encourages patients to seek surgical intervention. For the patient and the accompanying party, a shorter stay implies significant savings in food expenses and lost wages. Decreasing this economic burden is likely to increase the willingness of individuals to come forward for cataract surgery. 2.50 Patients are reluctant to seek cataract surzerv. As noted in paras. 2.40 and 2.41, several financial, logistical and socio-cultural factors prevent individuals from seeking cataract surgery. A major deterrent for seeking surgery has been poor surgical results. In some cases, even repeated attempts to change the mind of refuters have been unsuccessful, especially if someone in the community has had a negative experience with eye surgery. Improved quality outcomes and appropriate outreach and communication activities must be made available to counteract these barriers. 2.51 Experience of Bank-assisted Projects. The Bank Group's only experience in financing blindness control has been with the Riverblindness Control Program (WPS No. 0740) which covered several African countries, with WHO as the executing agency. Given the differences in the nature of the disease (caused by a parasitic worm) and the organizational arrangement of the project, no particular lessons can be applied to the proposed project; however, several implementation-related issues have been learned from the Bank's investments in the PHR sector in India and have been taken into account in project design.  - 12 - 2.52 IDA's financing in the PHN sector in India includes eight population projects, one maternal and child health project, four nutrition projects, an AIDS control project and a Leprosy elimination project. Three of the population projects have closed. The first two3 met most of their objectives but had little impact on the overall Family Welfare Program. The Third4 achieved very good outcomes in backward districts of Kerala, but mixed results in Karnataka. The Fourth (Cr. 1623-IN) and Fifth Population (Cr. 1931-IN) projects have already shown positive results on morbidity, infant mortality and fertility. The Tamil Nadu Nutrition Project (Cr. 2158-IN) was very successful in meeting its nutrition outcomes. The AIDS control project (Cr. 2350-IN) is being successfully implemented and has been identified by WHO as a model of interagency collaboration. The other ongoing projects are fairly new and the experience with them has been mixei. 2.53 The most significant lessons learned from implementation of these projects include: (a) the need for a strong project management team at the Central and State levels and of staff continuity for at least the first three years of the project; (b) the importance of stakeholders' support and involvement in project preparation and implementation; (c) the need for better training on administrative procedures at the district and state levels; (d) the value of closer supervision and follow up of the allocation of project funds and of expenditures fund. to ensure tiat they are timely and adequate; and (e) the need for attention to the qualitative aspects of projects through their implementation. G. Countrv Assistance Strategy and Rationale for IDA Involvement 2.54 The Bank's Country Strategy is aimed at accelerating economic development and alleviating poverty through structural adjustment and selected investments. To address the major problem of low human capital development in India, a key feature of the strategy is to improve access of the poor to human resource development programs, and to improve the quality, efficiency and effectiveness of these programs. The Social Safety Net Sector Adjustment Credit (Cr. 2448-IN) has helped to provide an enhanced policy environment in the social sectors and is being complemented by specific investment projects. In health, the Bank's two-pronged strategy is to help India reduce as quickly as possible the brirden of key endemic diseases such as leprosy, tuberculosis, blindness and malaria; and strengthen the states' health systems to provide efficient and effective primary health care over the medium term. The Blindness project is consistent with this strategy. It would address one of India's most extensive public health problems, and it would build institutional capacity at the Center and in the states and districts to develop and provide quality eye care. 2.55 IDA's involvement is justified on several grounds. First, the project would direct resources to one of the most cost-effective health interventions while preparing India technically and institutionally to address one of its high health priorities in a 3 First Population Project, PPAR No. 3748 and Second Population Project, PPAR No. 8896. 4 Third Population Project, Kerala and Karnataka, Cr. 1426-IN.  - 13 - sustainable fashion. Second, the proposed project is consistent with IDA's strategy of reducing inequalities by improving access to health care for the poor, particularly scheduled tribes and women. And third, IDA has a comparative advantage in serving as a catalyst to bring the changes needed for blindness control in India because of its access to high level international experts and its faniliarity with issues from experiences worldwide. 2.56 With IDA involvement, India would be able to cover most of the backlog of more than 10 million cataract blind case3 (of which 7.0 million are in the seven states),5 and be ready to deal with the increasing incidence of cataract resulting from changes in the age structure of the population. The chart below illustrates the future cataract situation in the seven project states with and without the project interventions, in quantitative terms. In addition to reducing the cataract backlog, the project would bring about significant qualitative changes through new technical and managerial standards, and a more equitable access to services. Cbart 1 Summary of Catarad Surgerla -wa and without Project interventions 7 mi_ c\ Ptjo Ptjj mt r wei _rje Pmu - rj~ Prjc Woec Fc3c .occ - ' .:,, A \ ' i % C 4 i\l _ * ; 2M or E ta 1 IOLlion atat i wt cli No Wbb No Wilb No Wllb No WBb No Whh No Wilh No With hot lNal PMJ Pmi P*l P" POi Pt PrC PM FM 11e Poj ftR 1995 1996 lg9 1998 1999 2000 2001 5 More than 1 1 mifllion cata surgeries will be performed through the project including most of the 7.0 million cataract blind, patients seeking surgery in the second eye (having had one-eye ICCE surgery in the past) and an increasing number of unilateral cases.  - 14 - 2.57 Along with the obvious high private returns, regaining sight has significant social returns. It allows economically productive people to return to work at least in 40% of the cases and prevents .dditional medical expenses resulting from blindness- related injuries. Sight restoration improves quality of life, social standing and reduces dependency on family mrembers. Without public sector intervention and external support, blindness would continue to increase among the poor, particularly women and rural populations. III. THE PROJECT A. Project Objectives 3.1 The objectives of the project would be to upgrade the quality of cataract surgery, expand NPCB coverage to underprivileged areas with special attention to women, tribal and isolated areas, and reduce the backlog of untreated cataracts to lower the prevalence of cataract blindness by more than 50% and bilateral blindness incidence by more than 30% in the seven participating states.6 B. Proect Stratecv 3.2 The project's strategy would involve: (a) improving the technical and institutional capacity at the Center and in the seven states to carry out high volume, high quality cataract surgery by strengthening existing institutions, introducing higher standards of care and upgrading the skills of ophthalmic personnel; (b) expanding service delivery to underserved areas and disadvantaged populations; and (c) facilitating the collaboration of the voluntary and private sectors in a systematic fashion with the view of taking care of the backlog and reducing the financial liability to the governments in the long term. 3.3 The project would be part of a larger NPCB strategy with short, mediwn and long-term goals. In the short term, the goal would be to reduce the backlog of cataract cases through improvement in service quality, increase in surgeon's productivity, and promotion of public awareness. In the mediumn term, it would be to develop appropriate physical and technical infrastructure and human resources for eye care in the periphery; and in the long-term, it would provide quality comprehensive eye care with extensive use of ECCE/IOL and extensive participation of the voluntary and private sectors. C. Proect SCOE 3.4 As indicated earlier, the project would be implemented in the states of Madhya Pradesh (MP), Uttar Pradesh (UP), Andhra Pradesh (AP), Rajasthan, Tamil N4adu, Orissa and Maharashtra. The seven states would perform over 11 million cataract surgeries during the 7-year project (Annex 9). In addition, the changes in policies, 6 Bilateral blindness incidence is reduced by operating on ataract cases while they are sfill unilaterally blind from cataract, i.e., before they become bilaterally blind.  - 15 - technical and managerial norms adopted by the NPCB through the project would have a broader national impact benefiting also non-project states. 3.5 This section describes the overall project framework and the aggregate costs of inputs for all seven states; however, the specific implementation strategies (e.g., combination of service delivery models), and the combination of inputs vary from state to state depending on their geographic characteristics, available facilities and manpower, social factors, and presence of NGOs, among others (see para. 3.10). Project preparation was carried out with the full involvement of each participating s .te, NGOs and private practitioners. D. New Policies. Procedures and Standards 3.6 The issues discussed in paras. 2.21 - 2.42 would be. addressed through the following changes introduced by the project: (a) The organizational restructuring of NPCB at the Center with delegation of authority and accountability for imnplemnentation to the district level through District Blindness Control Societies. (b) The adoption of new technical standards for patient screening, diagnosis, surgical procedures and follow-up. (c) The introduction of new policies for ophthalmologists training in Medical Colleges and new certification standards for ophthalmologists trained through NPCB. (d) The establishment of mechanisms for NGO/private sector collaboration in the project and new fee schedules for services by non-government providers. (e) The introduction of new policy guidelines for different service delivery models, i.e., medical colleges, district hospitals, camps in fixed facilities, camps in improi sed facilities. (f) The adoption of targeted strategies to facilitate access for disadvantaged groups, particularly women and scheduled tribes. (g) The introduction of cost-recovery schemes. (h) The adoption of new performance indicators based on surgeon's productivity and successful sight restoration, not only on numerical targets. (i) The agreement on a new approach to resource allocation based on "packages of inputs," i.e., combination of staffing, equipment and supplies needed for quality service delivery in a coordinated fashion.  - 16 - (j) The introduction of a "grievance" procedure for patients' claims in case of poor quality outcomes including those due to negligence. 3.7 At negotiations, GOI and the project states reconfirmed that these policies have been adopted by NPCB and would be implemented through the project. E. Project Description 3.8 The project would include four components: a) strengthening and expanding service delivery, b) developing human resources for eye care, c) promoting outreach activities and public awareness ard d) developing institutional capacity. ENHANCING QUALITY OF EYE CARE AND EXPANDING SERVICE DELIVERY (US$118.8 million: 84%) 3.9 The project would improve the physical, technical and managerial capabilities of different service delivery facilities including selected non-governmental organizations and private practitioners, to provide high quality cataract treatment in situ or through camps. The project would be implemented through a combination of service delivery models: medical colleges, base hospitals, camps in fixed facilities (i.e., CHCs and PHCs), camps in improvised facilities (in exceptional cases) and private practices, in collaboration among the Central government, the State governments, non-governmental organizations and the private sector (Annex 10). 3.10 The combination of service delivery models would depend on the geography, social composition, beneficiary assessment results, existing infrastructure, and presence of the private and non-govermnental s.ectors in each state. In states such as Tamil Nadu, which has a well developed network of hospitals but limited capacity for eye care, the strategy would be to strengthen these hospitals with basic infrastructure to carry out camps in fixed facilities and intensive screening camps. These facilities would be used by the government, the NGO sector and tL.e private sector. Madhya Pradesh, on the other hand, would provide similar services through Community Health Centers (CHCs) and Primary Health Centers (PHCs), particularly in tribal and other remote areas. In some instances, ophthalmic personnel would be permanently assigned to rural areas, while in others, services would be provided through itinerant personnel and mobile units based in hospitals or other medical facilities. 3.11 Improving Ouality Control for Service Delivery. The project has been designed in a manner consistent with WHO's manifesto on eradication of disablement and with the goal that individuals served by the project would have their quality of life improved by the surgery. The new emphasis would be on visual improvement, with patient's satisfaction as the ultimate indicator of success. The project would introduce several measures for quality control, including a team approach to surgical treatment, new technical standards and protocols for surgical and pre and postoperative care, and new indicators of performance based on vision restoration and patient satisfaction. The skills enhancement and management systems introduced in the other project components would be major factors in quality enhancement.  - 17 - (a) Team Approach. All surgeries would be performed with the support of a surgical team consisting of one ophthalmologist, two nurses, and an operating theater assistant. The ophthalmic assistant (OA) would be part of the medical team responsible for diagnosis, screening, and follow-up of routine cases. The out-patient department staffing pattern in a district hospital would include two ophthalmic assistants for each ophthalmic surgeon. Selected CHCs and PHCs in tribal and remote areas would be staffed, at a minimum, with an ophthalmic assistant, and surgical services would be provided by teams in mobile units. Surgeries would not be performed unless the required medical staff, equipment and consumables are available to ensure the highest quality of outcomes (Annex 11). (b) The new technical standards described in Annex 12 and developed with technical specialists from the Center, the states and the private sector would be adopted for all service delivery. The most salient features of these technical norms include: i) diagnostic guidelines and screening techniques, ii) minimum acceptable surgical standards, including number of stitches required, iii) treating unilateral cases only if ECCE with IOL can be done, iv) limiting ECCE/IOL surgeries to fixed facilities, and v) establishing operational guidelines for conducting camps. Selected Medical Colleges (30) and all district hospitals (220) would be equipped with the necessary additional inputs to perform ECCE/IOL as described in Annex 13. (c) Quality Visual Outcomes. The program's effectiveness would be assessed primarily in terms of visual outcomes, not only by the number of surgeries performed. Payments to NGOs and private surgeons would be based on records of quality outcomes and annual beneficiary assessments will be carried out to monitor patient satisfaction (see para. 3.48) (d) Grievance Committees. The states would require each DBCS to established a body to which any patient treated under the project may lodge any grievance relating to the treatment provided to that patient under the project. Each such body shall have adequate capacity to effectively assist such patients. 3.12 At negotiations, the Project States provided assurances that each DBCS would establish a body, consisting of members independent of the implementing authorities, which would be authorized to receive complaints from any patient receiving care under the Project and which would have adequate capacity to effectively assist such patients. 3.13 Strengening Service Capacity and Imoroving Efficiencv. Selected facilities would be strengthened based on a complete package of inputs required for essential high quality service delivery. This package would include: an operating theater, a ward with an average of 15 beds and related inputs, a medical "team," specified medical equipment and consumables, and a mobile unit (for district hospitals, subdistrict hospitals and CHCs). Selected PHCs would be equipped with a dark room and refraction equipment. Based on this 'package approach' the following additional infrastructure and manpower  - 18 - would be needed: approximately 480 operating theaters, 350 ophthalnic wards or permanent camp sites with 5880 beds (or cots) and related items7; and about 2200 dark rooms. Equipment would be inswled and operational only after qualified staff have been placed, and training initiated, as needed. At negotiations, GOI provided assurances that it would allocate resources on the basis of a minimwn "package of inputs" required for optinal service at each level of service delivery. 3.14 The following additional health personnel would be needed: about 364 ophthalmic surgeons, 110)0 staff nurses, 283 operating-theater-nurses/technicians, and 260 operating theater assistants or camp coordinators. An important feature of the project would be the placement of middle level ophthalmic personnel to the neriohery to facilitate outreach and patient identification. An ophthalmic assistant (OA) would be assigned to CHCs and selected PHCs in tribal areas. The ophthalmic assistants would play a major role at the primary health care level in diagnosing and screening patients, and providing basic eye care to the community. To facilitate transportation, about 350 OAs would receive loans to obtain their own means of transportation. A total of 1067 new OAs would be appointed.8 3.1' Manpower allocation would be done largely through retraining and redeployment of government ophthalmologists doing non-ophthalmological work, and itinerant services from ophthalmologists posted in fixed facilities or in the private sector, based on pre-established schedules. It is expected that with an increase in surgeon productivity, the additional personnel will be adequate to meet increasing demand in the long term. During appraisal, the mission reviewed the availability of trained ophthalmic assistants and nurses for future recruitment and found it satisfactory. 3.16 ReulariN the Oranization of Camps. To improve the quality and availability of services, the states have proposed different modalities to regularize camp services such as a "fixed day" approach or a yearly camp schedule. Camp organization would be done by the districts in consultation with NGOs and other service providers to avoid service overlap. The camps would be governed by the norms established by NPCB and would include three sequential activities: (a) an outreach and screening camp to identify patients, (b) a surgical camp to operate on selected patients, and (c) a postoperative follow up camp or household visits. Equipment and manpower from the fixed facilities would be used for the camps, e.g., mobile units from the medical colleges and district hospitals, ophthalmic personnel, equipment and other inputs. About 170 ? Simple steel frame bed, mattress, storage cabinet, stool and linen set. 8 The additional inputs listed above have been estimated following a situational analysis of existing infrastructure and manpower availability, and on the basis of an expected average productivity norm of 700 annual surgeries per surgeon and 50 annual surgeries per bed (taking into account lower productivity during the first two years until the project takes off) and the estimated 11 million surgeries to be performed.  - 19- mobile units would be assigned to district hospitals and selected CHCs. Additional mobile units would be allocated to areas with large tribal or dispersed populations. 3.17 Creating an Enabling Environment for Non-Profit Organizations and Private Sector Participation. To ensure expansion of coverage, the government would work with NGOs and private ophthalmologists. The following mechanisms wouid be used for involvement of the private and voluntary sectors: (a) grants to selected non-profit institutions capable of expanding their services, based on pre-approved proposals to finance equipment or facilities; (b) seed money to private ophthalmic surgeons to establish practice in underserved towns with populations of less than 50,000; (c) service contracts with private physicians to offer services in underserved urban slums, and tribal and other remote areas on a pilot basis; and (d) payments to NGOs for outreach, screening and service delivery camps. 3.18 NGOs conducting camps would receive support from the government in three modalities: (a) full payment per surgery if no inputs in kind are provided by the government (Rs. 250 and Rs. 300 for remote areas); (b) partial payment if govermnent inputs are involved (Rs. 175); and (c) payment for screening and outreach activities based on an "accessibility" norm. Payments per surgery to NGOs are well below the actual cost of cataract surgery which is estimated at an average of Rs. 500 for ICCE. It is expected that about 25 grants will be given for infastructure and medical equipment to NGOs based on approved proposals. 3.19 A small number of private ophthalmologists (about 200) are expected to request "seed" money to start their own practice9. It is estimated that about half of the 11 million surgeries during the project period will be done by the private and voluntary sectors, some through service conracts and fee payments from the project. Criteria for selection of participating NGOs is described in Anmex 14. Disbursement arrangements for grants, seed money and service contracts have been developed. At negotiations, the Project States provided assurances that they would select non-governmental organizations and private practitioners on the basis of the agreed criteria and procedures satisfactory to IDA. 3.20 Expansion of Coverage to Tribal and Remote Rural Areas. Special attention has been given in this project to the requirements of OD 4.20. Beneficiary assessments were conducted in selected tribal and non-tribal areas. The results show different epidemiological profiles for the two populations. Prevalence is higher among tribal populations (e.g. 2.4% vs. 2% for non-ribal populations) and the prevalence between the ages of 40-60 is considerably higher among tribal groups, as in Madhya Pradesh, for example. Patient satisfaction, access to facilities and access to spectacles are also lower 9 As a pilot scheme, a smal number of private practitioners, .cwted based on established criteria and procedures, would receive "seed* money from the project to start their own private practice in poor, undrserved areas. The surgeons would commit themselves to perform a certain umber of surgeries per year for a specified period of time.  - 20 - for tribal populations than for non-tribal. Lack of information, transportation or access to facilities, and lack of economic viability are the major reasons given for these discrepancies. The thrust of the project is to increase coverage and accessibility in these areas--including those isolated by water barriers-by strengthening peripheral facilities, intensifying outreach activities, and facilitating transportation and financial support to the potential beneficiaries. Annex 15 sunmmarizes the plan of action for tribal and isolated areas which is in compliance with OD 4.20. At negotiations, the Project States provided assurances that they would carry out the project activities among the tribal populations and other remote areas according to the agreed plan of action. 3.21 To assist in the implementation of this component the project would finance civil works, medical and other equipment, medical consumables (e.g. drugs, sutures, spectacles, IOLs), salaries, vehicles, office materials and equipment, and compensation to NGOs and private surgeons. DEVELOPING HUMAN RESOURCES FOR EYE CARE (US$5.0 Mqillion: 4%) 3.22 Through this component the project would allow strengthening of about 40 training institutions; it would finance the training of ophthahnological and selected health personnel on cataract diagnosis, screening, surgery (ECCE/IOL and ICCE) and follow- up; and management training for Central and State project managers, District Society Members, Project Coordinators, and other project staff requiring managerial and administrative skills. The time-table for training is described in Annex 16. The training component was designed in consultation with key ophthalmological personnel from the Central government, the states, private and voluntary sectors and representatives of bilateral institutions involved in training and blindness control. 3.23 To be selected as an NPCB training institution under the project, the institutions, including medical colleges, would need to fulfill pre-established requirements and commit themselves to training a specified number of ophthalmologists as described in Annex 17. Each trainee would be evaluated following completion of tae training. In addition, the Central Government is working with the appropriate authorities to modify the curriculum for the training of graduate students of ophthalmology in medical colleges based on the new technical norms of the project. At negotiations, the Project States gave assurances that govermnent ophthalmologists trained through the project would be required to sign a bond committing them to remain with the Government for a minimum of three years after completion of training, or reimburse the Government for the cost of training according to established procedures. 3.24 Training of Ophthalmologists would consist primarily in developing or upgrading ECCE skills, offei :- refresher courses in ICCE, and familiarizing the ophthalmologists with the new technical norms of the program. It is expected that during the life of the project, about 70% of surgeries would be carried out with ICCE technique since most of the cataract victims are in rural areas where ECCE/IOL is not feasible. Therefore, the training would not only expand the use of ECCE/IOL, but would emphasize quality upgrade of ICCE surgery. The training would involve: (a) training of trainers, i.e., faculty from medical colleges and selected ophthalmologists from the voluntary and public sector in private and government institutions selected according to the selection procedures shown in Annex 17; (b) training of practicing ophthalmologists  - 21 - (from the government and selected NGOs) in ECCE/IOL and high volume ICCE, including refresher training in ICCE; and (c) training of non-practicing government ophthalmologists who will re-enter practice. Training for private ophthalmologists'