TERMS OF REFENCE FEASIBILITY STUDY FOR HOSPITAL WASTE MANAGEMENT [],[] STUDY AREA A feasibility study is planned for the

study area of [], []. The study area is located [], covers an area of [] square kilometers and a population of [] inhabitants. The income level of the study area, expressed as Gross Domestic Product per capita per year, is []. INTRODUCTION Most wastes generated by hospitals and medical clinics are non-hazardous general wastes from hospital organization activities (i.e., including kitchen wastes, office materials, workshop residuals) and patient processing activities in wards which are not handling infectious diseases (i.e., first aid packaging, used but emptied disposable bed liners and diapers, disposable masks, pharmaceutical packaging, etc.). After source segregation of recyclables, disposal is typically by sanitary landfill. Potentially hazardous wastes from hospitals and clinics which have a pathogenic, chemical, explosive, or radioactive nature are called “medical wastes”. Medical wastes include the following:
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pathological wastes (i.e., body parts, aborted fetus, tissue and body fluids from surgery; and dead infected laboratory animals); infectious waste (i.e., surgical dressings and bandages, infected laboratory beddings, infectious cultures and stocks from laboratories, and all waste from patients in isolation wards handling infectious diseases); sharps (i.e., needles, syringes, used instruments, broken glass); pharmaceutical wastes (i.e., soiled or out-of-date pharmaceutical products); chemical wastes (i.e., spent solvents, disinfectants, pesticides and diagnostic chemicals); aerosols (i.e., aerosol containers or gas canisters which may explode if incinerated or punctured); radioactive wastes (i.e., sealed sources in instruments, and open sources used in vitro diagnosis or nuclear medical therapy); and sludges from any on-site wastewater treatment facilities may be potentially hazardous.

Pathological wastes should be destroyed by incineration under high heat (i.e., over 900o C with an afterburner temperature at over 800o C), although some countries require burial of human pathological wastes at official cemeteries for religious reasons. To reach these temperatures and have adequate afterburning and pollution control typically requires development of a regional medical waste facility. Smaller individual hospital or clinic incinerators may not be able to reach these temperatures and afterburning retention periods. Volatilized metals (such as arsenic, mercury, lead) and dioxins and furans could result from inadequate burning temperatures and retention periods. Other procedures to consider may include chemical disinfection or sterilization (i.e., irradiation, microwave, autoclave, or hydroclave) followed by secure landfill disposal of residuals. In some cases, following complete disinfection, some wastes may be recycled. For example, recycling by specialized contractors is sometimes arranged after disinfection of thick plastics, such as intravenous bags and tubs, and syringes. TERMS OF REFERENCE FOR HOSPITAL WASTE STUDY 1

Pharmaceutical wastes require destruction, secure land disposal or return to the manufacturer for destruction through chemical or incineration methods. Chemical wastes need to be source segregated according to their recycling potential and compatibility; and those which are non-recyclable may require stabilization, neutralization, encapsulation, or incineration. Hospital wastewater treatment sludges require treatment (i.e., anaerobic digestion, composting, incineration, etc.) which raises temperatures to levels that destroy pathogenic microorganisms. Radioactive medical therapy and diagnosis in high-income countries are divided into two categories: “open sources” which derive from direct use of the radiochemical substance, and “sealed sources” which involve indirect use of the substance within a sealed apparatus or equipment unit. Only open sources tend to result in radioactive wastes, as sealed sources are returned to the manufacture for recycling when exhausted or no longer required. Radioactive wastes typically include isotopes such as technetium 99, gallium 67, iodine 125, iodine 131, cesium 137, iridium 192, thallium 201, and thallium 204. These wastes are seldom present in low-income and middle-income developing countries, because the hospitals do not have the equipment and technology to generate these wastes. If generated, these wastes should be stored safely until the radioactivity has declined to acceptable levels and then disposed with general refuse to sanitary landfill. The half-lives of commonly used medical radionuclides for therapy, diagnosis, or imaging range from 6 hours to several days. Storage on-site in a secured chamber is typically recommended for a period of 10 half-lives, or for one to two months. The overall quantity of wastes generated in hospitals varies according to the income level of the country. For developing countries, the data base is limited, but it appears that the following range of quantities is likely: • general waste which is not contaminated, and can be handled with general municipal refuse: 1.0 to 2.0 kg/bed/day; and • contaminated medical waste which needs special management, and is considered potentially hazardous: 0.2 to 0.8 kg/bed/day. Low-income countries would tend to generate medical wastes on the low end of this range, while middleincome countries would tend to generate medical wastes on the upper end of this range. The study area is within a [] income country, based on ranking criteria established by the World Bank and published in its annual development report. Medical wastes, if not properly managed, pose a risk to the personnel who are handling these wastes, including custodial personnel and waste collectors, as well as to those providing disposal or picking through the wastes for recyclables. There is the danger that syringes will be recovered from transfer depots and disposal sites by waste pickers for recycling (i.e., by drug users). Contaminated containers for collection of medical wastes are not usually dedicated to only one site, but are circulated throughout cities as each skip truck brings an empty container to the hospital or clinic and removes the full one while it covers its daily collection route for general refuse. Incineration is generally considered the preferred technology for some, if not all, medical wastes. At a minimum, infected tissue, body parts, and laboratory animal carcasses are generally recommended to be incinerated. On-site incinerators operating on a batch basis or regional incinerators operating on a continuous basis are considered appropriate technology. Because of the cost of meeting stringent air pollution control emission standards, many high-income countries are taking steps to steam sterilize, TERMS OF REFERENCE FOR HOSPITAL WASTE STUDY 2

irradiate, chemically disinfect, or gas/vapor sterilize some of the medical wastes. One hospital incinerator with a capacity of 0.75 tonne/hour, operating on a continuous feed, could cost from $US 0.5 to 1.0 million to implement. Air pollution control systems, if they are added to meet 1995 USA standards, could cost another $ 0.5 to 1.0 million to implement. Incinerators which operate on a batch basis are typically dedicated to one hospital, as their capacity is limited to less than 1 tonne/day. Regional incinerators would typically be designed to operate on a continuous feed basis. These equipment costs do not include transportation, customs, and setup costs within the study area. Transportation and setup may add about 10% to these costs. If government imports the equipment, especially as it is for waste management purposes, customs may not need to be paid. However, if the private sector is building the facility and needs to import the equipment, customs could add about to these costs. Civil works and land costs which are local costs may add about 30% to these costs. While the costs/tonne of treatment/destruction are likely to be high (about $100 to $300/tonne depending on the level of pollution control required), the low quantities of medical wastes in developing countries would result in a costs which generally would be less than 1% of the most hospital's operating budget, exclusive of salaries. Therefore, the proper treatment/destruction facilities are likely to be affordable. Hospitals interviewed in various developing countries have indicated a willingness to pay to cover these costs. Hospital waste treatment/destruction facilities could be implemented through one or more Design, Build, Own, and Operate (DBOO) or Design, Build, Operate and Transfer (DBOT) concession agreements of 10 to 15 years duration. Or the government could implement the facilities and arrange for service contracts of 2 to 5 years for operation and maintenance. Each hospital would be required to pay tipping fees which fully cover the costs of investment, debt service and operation. As part of the privatization agreement, the company providing the treatment/destruction services could also be awarded the task of also providing collection of the wastes from each hospital and maintaining a manifest system to track the waste from source to ultimate disposal. Secured sanitary landfill is generally considered the preferred technology for medical wastes which do not require incineration or disinfection, such as packaging materials and general kitchen wastes. Nevertheless, special measures to fence and control access to the area of landfilling for medical wastes are essential. No waste picking should be allowed in the secured area. Also, the machinery for compacting refuse should not come in direct contact with the waste. Instead, the waste should be dumped into a trench and a adequate layer of soil dumped over the waste. Only thereafter is it recommendable that the machinery work over the soil covered waste to compact it and grade the surface so that infiltration of rainwater is minimized. STUDY OBJECTIVES The feasibility study will assess the technology options for medical waste treatment/destruction. The study will result in recommendations which outline proposed numbers, sizes, and types of medical waste treatment/destruction facilities. Technologies to be considered include incineration, irradiation, chemical disinfection and sterilization. For purposes of the proposed study on hospital waste management, the following objectives are to be addressed:

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determine the quantity and character of hazardous medical wastes generated by hospitals and clinics in the study area; evaluate the progress being made in source segregation and develop recommendations for improving the source segregation systems of hospitals and clinics in the study area; estimate the capacity requirements for existing hospital treatment/destruction facilities for the study area; determine the optimum technology for cost-effective and environmentally safe treatment/destruction of medical wastes in the study area; based on transport distances and economies of scale, as well as available sites for implementation, determine the number and size of hospital waste treatment/destruction facilities needed; provide a preliminary design, including a typical site layout, and estimate land, capital, operating, and staffing requirements for each of the hospital waste treatment/destruction facilities recommended; and assess the environmental impact issues of implementing each the hospital waste facilities recommended and recommend appropriate mitigative measures to enable the facilities to meet [] environmental requirements.

SCOPE OF WORK Task 1: Waste Quantity and Character. Determine the quantity and character of medical wastes generated in the study area, including pathological, infectious, sharps, pharmaceutical, chemical, aerosol, and radioactive wastes. As part of the effort to make this determination, accomplish the following activities. Based on the records kept by the solid waste authorities within the study area and the hospitals, determine the volume and weight of medical wastes being collected. If data does not exist, weigh hospital waste loads for a period of at least 4 days. Visually describe the composition (on a percent wet weight basis) of medical wastes to be managed by treatment/-destruction facilities, such as the contaminated paper products, plastics, fabrics, wood, rubber, cloth, pharmaceutical, tissue, body and bedding materials. Estimate the calorific heating value of combined mix of medical wastes, on both a dry and wet weight basis, based on the apparent contents of the waste, from the above visual observations. This will involve examining wastes at least [] large hospitals and examining medical wastes being discharged at disposal sites. Sample, on an accepted random sampling basis, at least 4 loads of medical waste arriving at disposal sites. Conduct laboratory analyses of the calorific values and moisture contents of the samples. Report results in terms of wet “as received” lower heating value (in kcal/kg and BTU/pound), dry higher heating value (in kcal/kg and BTU/pound), and moisture content (percent on a wet weight basis). Assess whether there are liquid wastes from the hospitals which could be burned in conjunction with the solid medical wastes and might add to the heat value of the overall waste mixture, such as alcohol, coolants, oils, solvents, strippers, thinners, phenols, resins, and emulsions. Assess whether the addition of these liquid wastes would compromise the air emissions from the proposed treatment/destruction facility. Estimate the quantities of the liquid wastes which could be burned with the solid medical wastes.

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Task 2: Source Segregation Systems. Visit at least [] hospitals to review their systems of medical waste segregation, storage, and disposal. Estimate the percentage of wastes which are being segregated, out of the total being generated. Inspect the storage facilities and estimate the pre-collection volume of medical waste being generated and segregated. For each of the hospitals visited, estimate the volume/bed/day of refuse. If there are wide variations among the hospitals visited, determine whether the variance is related to compliance with the source segregation system. Estimate the total quantity of medical waste which would be generated in the study area if all hospitals were fully implementing adequate source segregation. Provide an estimated breakdown in terms of the quantity of medical waste requiring: (i) special storage for radiation decay, (ii) treatment/destruction in a medical waste facility, and (iii) amenable to recovery and recycling. Task 3: Project Waste Quantities and Characteristics. Based on the economic level of the study area, economic growth projections, population growth projections, trends in hospital waste generation and source segregation, project the quantity and characteristics of medical wastes which are expected to be generated over the next 20 years. Task 4: Regulatory Requirements. Determine all pollution control standards to be met by a medical waste treatment/destruction facility in []. Particularly determine the air emission standards which are currently required by [] law and which would be likely to be required in the next 10 years. Assess the corresponding air pollution control requirements for particulates removal, flue gas scrubbing, and dioxin removal. Assess the costs versus the pollution control differences between dry versus wet scrubbing systems. Outline the environmental permitting, building permitting, and other permitting requirements and procedures which treatment/destruction facilities for medical wastes would need to address. Also outline any public participation or public hearing requirements and procedures. For each requirement, list the lead agency to be contacted. Assess the typical time demands for proposed facilities to obtain permits and address environmental impact assessment and public participation requirements. Task 5: Treatment/Destruction Options. For the types, quantities and sizes of materials included in the study area’s medical wastes, assess alternative technologies and facility sizes for treatment and destruction. The assessment shall compare the alternatives on the basis of capital cost, operating cost, ease of operation, local availability of spare parts, local availability of operational skills, demonstrated reliability, durability, and environmental impacts. The technologies to be considered include: incineration, irradiation, sterilization, and chemical disinfection, and secured landfill. On the basis of this assessment, recommend a process flow for economic and environmentally sound management of medical wastes in the study area. Task 6: Residuals. For the recommended process flow which would provide treatment/destruction of study area’s medical wastes, assess the quantity and characteristics of residuals. Include assessment of process residuals (such as incinerator ash), as well as pollution control residuals (such as flue gas cleaning sludge, particulates, spent filters, and spent activated carbon). Task 7: Strategic Location and Sizing. For the recommended treatment/destruction system, assess whether there are significant economies-ofscale to be considered. Also, examine the travel times and distances to drive in the study area from the TERMS OF REFERENCE FOR HOSPITAL WASTE STUDY 5

various centers of medical waste generation to potential locations for treatment/destruction facilities. Also, examine the travel times and distances to drive from the facilities to the location for residuals disposal. Economically analyze whether the study area would be best served by one or more than one treatment/destruction facility. Determine the optimum number and location(s) of facilities. Task 8: Preliminary Design. Develop a model process flow diagram and site layout for the recommended treatment/destruction facilities. Include treatment processes for wastewater, cooling water, drainage, odor pollution, and air pollution in the model process flow diagram. Include facilities for parking, gate control, weighing loads, administration, worker sanitation and washing/changing, worker cafeteria and training, and truck washing/disinfection in the model site layout. Provide a conceptual floor layout for each of the buildings recommended with the site layout. Assess spatial requirements for the facilities, as a function of their recommended medical waste handling capacities. Determine the electrical power supply available and the type of fuel (i.e., oil, natural gas) available for operating the facility. Assess the potential for waste-to-energy conversion and which type of energy recovery would be preferred, such as steam, hot water, hot air, thermal liquid, electricity. Outline user requirements, such as steam pressure requirements or hot water requirements. Task 9: Land and Investment Requirements. Based on the spatial requirements estimated above, determine how much land is required for each of the recommended facilities. Outline the land acquisition issues and constraints which might exist in the study area, including human resettlement issues and constraints. Based on local land values and resettlement costs, estimate the costs of land acquisition. Assess building requirements, including foundation requirements for the study area. For the model facility designs developed above, and in keeping with local building requirements, develop budgetary estimates for implementation. Include investment costs for site preparation, construction of civil works, stationary equipment, and mobile equipment. Task 10: Operating Requirements. Determine the cost of consumable supplies and utilities associated with operating the proposed treatment/destruction facilities. For any potential materials recycling and/or energy recovery, estimate the revenue potential based on current market prices. List the manpower requirements for the proposed treatment/destruction facilities, including managers, planners, administrators, supervisors, operators, guards, and attendants. Estimate the cost of salaries required to operate the facilities. Based on the cost of consumables, salaries, insurances, registrations, investment depreciation, and debt service, estimate the total annual cost to own, operate and maintain the proposed facilities. Estimate the cost/tonne of waste processed if operating at 70% capacity initially and 90% capacity within 10 years. Task 11: Environmental Study and Mitigation. Prepare an environmental report which reviews the environmental issues related to the proposed treatment/destruction facilities. These reviews are to be conducted in accordance with local environmental impact assessment guidance, as well as the World’s Operational Directive 4.01, “Environmental Assessment”. For adverse impacts identified within the reviews, outline mitigative measures which need to be included within the proposed design (including mitigative by wastewater treatment, air pollution TERMS OF REFERENCE FOR HOSPITAL WASTE STUDY 6

control, odor control, etc., processes). Further outline mitigative measures which should be included within the operational procedures. In addition, provide a monitoring program for monitoring throughout implementation and operation activities. If any of the proposed sites for the facilities have inhabitants or tribal nomadic dwellers, address the World Bank’s requirements under Operational Directive 4.30, “Involuntary Resettlement” or any other relevant guidance provided by the agencies participating in this project. Task 12: Implementation Schedule. Develop an anticipated schedule for securing all required permits, including environmental permits, for implementation of the proposed facilities. Include time for public participation, as appropriate. Develop an implementation schedule for siting, land acquisition, human resettlement, land preparation, construction, training, demonstration, and start-up of the proposed facilities. Include scheduled steps to advertise tenders, evaluate bids, and negotiate contracts. Task 13: Implementation Strategy. Assess the alternative ways in which the proposed facilities could be implemented and provide adequate discussion of the pros and cons of each alternative to enable decision-making. Include consideration of the following: (a) the local or central government designs, builds, owns and operates the facilities; (b) the local or central government designs, builds and owns the facilities and contracts for operation by government; (c) the local or central government designs, builds and owns the facilities and leases them to the private sector for their operation; (d) the local or central government develops design performance requirements and gives a concession to the private sector to design, build, own, and operate facilities; (e) the local or central government licenses private firms to compete with each other to design, build, own, and operate facilities; or (f) hospitals collectively organize a semi-private enterprise to design, build, own, and operate facilities. Task 14: Financial Package. Recommend financing arrangements for project implementation. Based on whether the money for implementation is to be borrowed by the hospitals, the government, or invested by the private sector, provide a financial package which would enable final design and procurement activities to begin immediately at the conclusion of the study. Task 15: Regulatory Framework. Review the existing regulations, strategies, policies, and enforcement practices at the local and central government level concerning the management of medical wastes, and the more general topic of hazardous wastes. Identify limitations and deficiencies in the regulatory framework. Develop specific recommendations on areas which need to be improved within the regulatory framework, so that hospitals, communities, and waste haulers have the appropriate incentives and disincentives to provide proper waste management. Task 16: Technical Seminar. Provide a seminar to government officials and hospital administrators on the findings of this feasibility study, upon completion of the draft final report. Obtain their review comments during the seminar and address their comments in finalization of the report. STUDY TEAM

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The team to conduct the feasibility study will need to have extensive experience in hospital waste management and design of treatment/destruction facilities. The team will need to have practical knowledge of the pros and cons of various hospital waste treatment/destruction options. The team will also need to be familiar with the assessment of technology options under the range of unique skill, management and financial conditions which exist in developing countries. The team will need to be qualified to put together a financial proposal for implementation of the study recommendations. Resumes of the qualifications and experience of the key members of the team will be the key criteria used to evaluate proposals. REPORTS Provide a diagnostic report after completion of Tasks 1 to 4, within 2 months of the commencement date of the contract. Provide an interim report after completion of Tasks 5 to 10, within 4 months of the commencement date of the contract. Provide a final draft report after completion of Tasks 11 to 15, within 6 months of the commencement date of the contract. Conduct the technical seminar required under Task 16, and then issue the final report within 8 months of the commencement date of the contract. Ten copies of each report are to be provided.

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