E & EERGroup E & ER Group Phone 510-799-2551 628 Second Street Fax 510-799-2572 Rodeo, CA 94572 USA Tv2Q Audit of Biomedical Waste Management Practices St. Kitts and Nevis E673 Prepared for: Natural Resources Management Unit (NRMU) Organization of Eastern Caribbean States (OECS) January 18, 2002 Table of Contents Executive Summary ................................................i Introduction ............................................... ii Objectives ...............................................1 Approach ...............................................1 Inventory of Major Health-Care Facilities .............................................2 Assessment ................................................2 St. Kitts and Nevis Laws and Regulations ................................................2 Existing Waste Treatment Technology ...............................................3 St. Kitts Policies and Procedures ................................................4 Color Coding and Signage ................................................4 Waste Collection, Storage, and Transport ..........................................4 Waste Treatment ................................................8 Waste Disposal ................................................9 Employee Training ............................................... 10 Nevis Policies and Procedures ............................................... 11 Color Coding and Signage ............................................... 11 Waste Collection, Storage, and Transport ........................................ 11 Waste Treatment ............................................... 12 Waste Disposal ............................................... 13 Employee Training ............................................... 14 Recommendations ............................................... 14 Short-Term Recommendations for St. Kitts ...................................... 14 Short-Term Recommendations for Nevis .......................................... 16 Long-Term Recommendations for St. Kitts and Nevis National Laws and Regulations ............................................... 16 Institutional Policy, Administration, and Organization ................. 17 Occupational Safety and Health ............................................... 19 Waste Segregation and Classification ........................................ 19 Waste Minimization ............................................... 22 Labeling, Color Coding, and Signage ......................................... 22 Waste Collection ............................................... 23 Handling and Transport Within the Facility ................................. 24 Transport Outside the Facility ............................................... 24 Waste Treatment ............................................... 25 Final Disposal ............................................... 27 Summary of Biomedical Waste Management Procedures ......... 28 Contingency Planning ........................................ 28 Employee Training and Public Education ................................... 33 Appendixr Sources of Information ........................................ Al Waste Disposal Policy and Procedure - JNF Hospital ............. ....... A2 Sample Institutional Policy ............ ............................ A3 Waste Minimization ......................................... 4 Sample Poster ........................................ A5 Ideas for Hazardous Waste Minimization ........................................ A6 Executive Summary This report presents the results of an audit of biomedical waste management practices in St. Kitts and Nevis. The audit began with meetings with various stakeholders and site visits to the main hospitals, a representative health center, a long-term care facility, dental office, and waste disposal sites in St. Kitts and Nevis on November 13-15, 2001 The following assessment is based on the information received, observations, photo-documentation, review of relevant documents, and data obtained after the visit. While there are some laws and a proposed bill dealing in a general way with biomedical waste, there are no specific regulations or guidelines on the national level. Recommendations are made on various elements that could be addressed in future regulations. Incineration is the waste treatment technology in use at St. Kitts and Nevis Unfortunately, the incinerators at JNF Hospital and Alexandra Hospital are of obsolete designs and do not meet the generally accepted criteria for good combustion. Moreover, both incinerators are damaged. The Alexandra Hospital incinerator, in particular, is almost completely destroyed; it operates essentially as an open-burn platform and its use should be halted immediately. On the ground around both incinerators, one finds partially burned residues, such as sharps, blood tubes and other debris, which pose a serious hazard to workers. Recommendations are made to keep these areas clean. Because of the toxic air pollutants associated with these incinerators, recommendations are made to replace the incinerators with treatment technologies that are more efficient, cleaner, and have much lower adverse impacts on public health and the environment. The main hospital, JNF Hospital in St. Kitts, has a written waste disposal policy that has not been implemented. No color coding or signage is used. These problems need to be addressed in the short-term. At JNF Hospital and Newtown Health Center, sharps are collected in cardboard sharps containers that are not puncture resistant. Recommendations are made to use rigid, puncture-resistant sharps containers. Newtown Dental Clinic uses rigid, puncture-resistant containers that meet international standards. At JNF Hospital, blood tubes are collected in empty bleach bottles; except for the lack of biohazard markings, this is an acceptable practice. Fluids from placenta waste are disposed in the sanitary sewer. This is also an acceptable practice as long as health-care workers are protected from splashes from body fluids. Except for the lack of color coding and biohazard markings, the method of collection of cultures is also acceptable. The numbers of regular garbage containers and biomedical waste containers are appropriate for the size of the facility. In-house transport of waste is done using an open trolley. Recommendations are made to use a dedicated, fully enclosed cart. Treated waste residues from the incinerator are sent to the Conaree disposal area. It is recommended that the treated waste be buried in areas not accessible to waste recyclers or pickers. At Alexandra Hospital, there are no written policies, no color coding, nor signage. These need to be addressed in the short-term. Sharps waste is collected in puncture-resistant containers that meet international standards. Blood tubes are collected in plastic-lined corrugated cardboard containers. Surgical and pathological wastes, as well as placenta waste, are collected in plastic bags. Except for the lack of color coding and in some cases biohazard marking, these practices are acceptable. Until such time as a new treatment technology is available, it is recommended that biomedical waste from Alexandra Hospital be buried in deep trenches at the Low Ground disposal site; the trench areas should be fenced in with clear waming signs and pickers should not be allowed access to those areas. Employee training is informal and infection control committees are either dormant or inexistent in all facilities visited. Recommendations are made to include biomedical waste management in formal in-service training for employees. Recommendations are also made to form or reactivate infection control committees that would initially take responsibility for biomedical waste management in the short-term. Long-term recommendations are made to form Waste Management Teams to deal more comprehensively with waste management in the near future. Long-term recommendations are made for St. Kitts and Nevis on various elements of biomedical waste management. They include administrative and organizational recommendations outlining the responsibilities of staff members. Recommendations are also made on occupational safety and health practices, classifications of biomedical waste, waste minimization, color coding and labeling, specifications for collection containers, in-house transport, transport outside the facility, recommended procedures for the treatment of different categories of waste including expired pharmaceuticals, and final disposal. These are summarized in five tables in the report. Specific recommendations are also made on contingency planning, employee training, and public education. In the appendix, resources are provided on general hospital waste minimization as well as hazardous chemical waste minimization. A sample policy paper and educational poster are also presented. INTRODUCTION This project is a component of a larger World Bank-funded program to address the problem of solid and ship-generated wastes with the goal of protecting the environment and enforcing the MARPOL 73/78 Convention. The program involves six members of the Organization of Eastem Caribbean States (OECS) and is coordinated by the Natural Resources Management Unit of OECS. This particular component of the project deals with the management of health-care waste and has four specific tasks: (1) an audit of medical waste management practices, (2) review of existing medical waste treatment technologies, (3) development of a national biomedical waste management plan, and (4) a training program/implementation and monitoring. This report corresponds to the first of the aforementioned four tasks. It was prepared by Dr. Jorge Emmanuel of the E & ER Group based in Rodeo, California, USA. The author is grateful to Mr. Clifford Griffin of the Ministry of Health and Mr. Theodore Mills for their invaluable assistance during his first visit. He also acknowledges the support of Permanent Secretaries Mr. Elvis Newton and Mr. St Clair Wallace, as well as Ms. Nona Adams of JNF Hospital and all the personnel who provided information at facilities in St. Kitts and Nevis. Jorge Emmanuel, PhD, CHMM, PE, REP, DES President, The E & ER Group 628 Second Street Rodeo, CA 94572 USA Ph. 510-799-2551 Fax 510-799-2572 E-mail: iemmanuelkcmindspring com I of 1(,1; /I mo ll"(di It: . /.J}d'"(WICI / 1°i.J1c ' AUDIT OF BIOMEDICAL WASTE MANAGEMENT PRACTICES The objectives of this report are to review the current status of biomedical waste management on St. Kitts and Nevis, and to present recommendations. The consultant's recommendations are based on: a) The need to safeguard public health, enhance occupational safety of health care workers, and protect the environment without compromising patient care b) The need to conform to generally accepted international practices and standards related to the collection, transport, and disposal of potentially infectious waste c) The desirability of regional harmonization, where appropriate, of practices and standards related to biomedical waste management. Information for this report was obtained from meetings with stakeholders and visits to various facilities conducted from November 13 to 15, 2001. Specific sources include: a) Data gathered during meetings with govemment officials, health care facility staff, solid waste management personnel, and other stakeholders b) Observations and photo-documentation of existing practices and technologies during site visits to the main hospitals, clinics, a long-term care facility, and a dental office at St Kitts and Nevis c) A review of relevant documents d) Responses to follow-up requests for additional information e) Consultations with personnel from the Natural Resource Management Unit of the Organization of Eastern Caribbean States. Appendix Al gives a list of the facilities visited, personnel who provided information, and documents and photos obtained. *h!d,I i; > BI0Inc'dI a,t Itr'1C e .\LZ)Id<,!;'I;(,: ['2;: I :. a Joseph N. France (JNF) General Hospital is the main hospital in Basseterre, St. Kitts. It was constructed in 1968 and currently has a 74-bed capacity. Completion of new construction sometime in 2002 will expand the bed size to 150. JNF Hospital offers a range of medical services including general surgery, radiology, obstetrics and gynecology, emergency, and pharmacy. Two smaller hospitals offering a more limited range of services are Pogson Hospital in Sandy Point, St. Kitts, and Mary Charles Hospital in Molineux, St. Kitts. Of these, the consultant visited JNF Hospital. There are eleven health centers in St. Kitts: Basseterre, Newtown, St. Peter's, Cayon, Molineux, Tabemacle, Saddlers, Dieppe Bay, St. Paul's, Sandy Point, and Old Road. These health centers offer matemal health, male health, and child health clinics as well as communicable and non-communicable diseases, minor treatment, immunization, and other services. Of these, the consultant visited Newtown Health Center. Alexandra Hospital in Charlestown, Nevis has a 54-bed capacity and was originally constructed in 1951. The hospital provides a range of services including general surgery, obstetrics and gynecology, emergency, and pharmacy. There are six health centers in Nevis: Chariestown, Combermore, Gingerland, Brown Hill, Cotton Ground, and Butlers. They offer the same services as the health centers in St. Kitts. The consultant visited Alexandra Hospital in Nevis. St. Kitts and Nevis 1. Laws and Regulations A country's approach to managing biomedical waste is determined in the first place by the country's laws and regulations. The relevant legislation are: (1) The Public Health Act of 1969; (2) The Litter (Abatement) Act of 1989; and (3) The Saint Christopher and Nevis Solid Waste Management Corporation Act of 1996. Directly related to biomedical waste is a section in the Solid Waste Management Corporation Act that includes, among the duties of the corporation, the provision of facilities for the treatment and disposal of medical waste. However, none of these laws has any detailed provisions on biomedical waste. There is a proposed Solid Waste Management Bill of 2000. The Solid Waste Management Bill defines 'biomedical waste" as including 'any solid waste containing human or animal fluids, flesh, bones or other body parts except hair." Annex 1, Schedule 1 of the bill classifies the following waste streams, among others, as hazardous waste: Y1 Clinical wastes from medical care in hospitals, medical centers and clinics 2 4tI I,ht of Ri'ow;'da h ; Wa r:'c AIanlX .'c<,, UT JZ ( tJC I. Y2 Wastes from the production and preparation of pharmaceutical products Y3 Waste pharmaceuticals, drugs, and medicines There are no classifications and formal definitions of the different types of medical waste. Part II of the bill directs the Solid Waste Management Corporation to "identify methods by which hazardous and bio-medical wastes and other specified classes of solid waste substances are to be managed". Except for these general provisions in the proposed bill, no specific regulations on biomedical waste management exist. Therefore, while there are some related laws and a proposed bill, there are really no regulations governing biomedical waste management in St. Kitts and Nevis. It is recommended that future regulations incorporate various aspects of a national biomedical waste management plan. 2. Existing Waste Treatment Technology Incineration is the waste treatment technology used in St. Kitts and Nevis. The hospitals use single-chamber, oven-style incinerators. The two incinerators examined by the consultant at the major hospitals (JNF Hospital in St. Kitts and Alexandra Hospital in Nevis) are damaged. Both incinerators do not meet the criteria for good combustion and are a source of toxic pollution and hazardous residues. State-of-the-art incinerators generally involve a rotary kiln or dual-chamber design with auxiliary burners and controllers to carefully control and maintain high temperatures. The incinerator chambers must operate at about 1,500-3,000 OF (800-1,600 IC). In the 1960's, many of the new hospital incinerators then were dual-chamber controlled-air designs: medical waste bumed in a primary chamber operating typically at 1,400 OF (760 OC) with controlled amounts of air, followed by a secondary chamber operating usually between 1,800-2,200 OF (980-1,200 OC). Controllers, auxiliary bumers in both chambers, and an air injection system were used to maintain high temperatures. The incinerators examined by the consultant in St. Kitts and Nevis belong to an even older generation of incinerators. Biomedical waste incinerators are a known source of highly toxic dioxins and furans, particulate matter (fly ash), hydrogen chloride, hydrogen fluoride, sulfur dioxide, nitrogen oxides, carbon monoxide, lead, mercury, cadmium, and other air pollutants, as well as hazardous ash. Air pollution control devices, such as scrubbers and baghouse filters, lessen but do not eliminate these air pollutants. Dioxins and furans are considered among the most toxic substances because of the extremely low doses at which they can affect humans and animals. Particulate matter not only contribute to air pollution but can be dangerous in themselves because of trace amounts of toxic chemicals that adsorb on the surface of particulates which can then be inhaled into the lungs. Gases such as hydrogen chloride and sulfur dioxide contribute to air pollution, form acid rain, and can damage plants directly or through their acidity. Heavy metals such as lead and mercury are toxic when taken into the body; they are released with the fly ash and deposited on soil or surface water thereby contaminating the environment. 3 .Iudzu ! r o! ii:on"Cu;C( I(a IIi If a:'l' .1 /tIa ' ( ur /), a trc' Single-chamber incinerators, which only operate at about 550 to 750 OF (about 300-400 OC), emit black smoke and volatile organic compounds in addition to the pollutants listed above. Unfortunately, the temperatures at which single-chamber incinerators operate fall within the temperature range in which highly toxic dioxins and furans are formed, i.e., 480-840 OF (250-450 IC). If proper operating conditions are not met, incinerators also release pathogens through discharge air and residues. Specific comments and recommendations are made below regarding the two incinerators examined. St. Kitts: Biomedical Waste Management Practices i. Policies and Procedures JNF Hospital has a written "Waste Disposal Policy and Procedure" (no date). A copy of the text is provided in Appendix A2. The policy was developed in the last few years. The policy requires color coding of bags or containers: red for potentially infectious waste, yellow for any trace chemotherapeutic waste, clear bags for non-contaminated waste, and red or yellow puncture-resistant containers for sharps. It also describes collection and treatment methods, e.g., use of autoclavable red bags and on-site autoclaving for cultures. Some treatment methods are left unspecified, such as those for sharps waste. The written policy is a good start in standardizing color codes and categorizing waste components. However, the policy has not been implemented. 2. Color Coding and Signage No color coding or signage is used in any of the health care facilities visited. Sources indicated that color coding had not been in place before and there has not been an impetus to change the current practices. At JNF Hospital, health care staff reported that yellow bags have been used on rare occasions for highly infectious waste (described as waste from patients with HIV). However, this contradicts the written policy that yellow bags are to be used for trace chemotherapy waste. Color coding and signage are important aspects of waste segregation for effective waste management, protection of public health, and occupational safety. They are the generally accepted standards for handling health-care waste. The lack of color coding and signage is a serious problem that needs to be addressed in the immediate term. 3. Waste Collection, Storage, and Transport Sharps collection: At JNF Hospital, waste is segregated at the point of generation. Sharps waste is collected in cardboard "UNIVEC Safety Box' containers (Garden City, New York, USA), shown in Figure 1. The sharps containers were found in the laboratory, surgical ward, and other areas. The UNIVEC containers are approximately 6.1 liters (6.5 quarts) in volume and fill up approximately every two days. During the 4 site visit, none of the containers were overfilled. Sources expressed difficulty in obtaining sharps containers. Rigid sharps containers take up much volume during shipment and consequently have higher shipping costs. In contrast, the UNIVEC boxes are collapsible and compact when shipped and are unfolded just before use. Figure 1. UNIVEC Box At the Newtown Health Center, sharps waste is also segregated at the point of generation and collected in UNIVEC boxes. Collectors drive to the clinic twice a week and transport the sharps boxes when full to JNF Hospital for incineration. Syringes are loaded vertically into the UNIVEC box The staff commented on the problems getting needles to go down into the box, as needle points tend to stick to the sides and sometimes puncture the walls of the cardboard box. At least one needle-stick injury was related to the consultant: a needle sticking out of a UNIVEC box had punctured a nurse on the thigh as she was transporting the box back to the clinic after conducting vaccinations at a school. At the Newtown Dental Clinic, sharps waste is collected in Sage horizontal- loading, rigid plastic sharps containers (Sage has now sold its sharps container division to Kendall in Crystal Lake, Illinois, USA). Each container (Figure 2) has an approximate volume of 7.6 liters (2 gallons). The containers are eventually sent to JNF Hospital for incineration. The Sage containers are rigid, puncture- resistant, durable, and meet intemational standards. Figure 2. Sage Horizontal-Loading Sharps Container Behind Dental Chair During the site visit, three large containers were lined with white plastic bags and contained a large accumulation of sharps. Two of the containers were nearly full and had no lids. Sharps containers should have lids to prevent accidental spillage. They do not need plastic bags if they are incinerated. However, if the rigid containers are reused, the plastic bags should not be removed from the containers (since needles can easily puncture the bags). Instead, the contents (sharps and bag) should be dumped directly into the incinerator chamber in a 5 4i (ua uf Bioin1e(dtc tl 11 i.ste AkiunqL,lC 1elm ! Practcts(" manner that would prevent needle-stick injury to the worker. The containers should then be cleaned and disinfected. The handling, collection, and disposal of contaminated sharps waste pose one of the greatest occupational hazards facing health care workers worldwide because of the frequency of needle-stick injuries and the potential transmission of bloodbome pathogens. For this reason, the generally accepted performance criteria for sharps containers include: puncture resistance, rigidity, durability, leak resistance on the sides and bottom, ability to be closed, and functionality under all normal conditions during their use. Based on the anecdotal information provided and a visual examination of the UNIVEC boxes, the UNIVEC containers do not seem to meet basic performance criteria of puncture resistance during normal usage, whereas the Sage containers used in the Newtown Dental Clinic meet the criteria. Collection of other biomedical waste and regular garbage: At JNF Hospital, surgical and pathological wastes are collected in black bags. The "Waste Disposal Methods" table in the existing hospital policy does not specify a color for the containers or bags to be used for pathological waste. However, the use of black bags is not in compliance with the general policy statement that requires all potentially infectious waste be placed in red bags. Blood tubes and vials are collected in empty bleach bottles as shown in Figure 3. The containers seen by the consultant are rigid and impermeable but do not have biohazard markings. The use of plastic bleach bottles for collecting blood tubes is an acceptable practice as long as containers are properly marked with the international biohazardous label. Figure 3. Blood Tubes Inside Bleach Bottles Inside the Incinerator Wet solid placenta waste is collected in covered white pails and the liquid portion is drained into the sewer. Disposing of fluids from placenta waste into the sanitary sewer is accepted practice as long as health-care workers are protected from splashes. Collecting solid and semi-liquid placenta waste in pails is acceptable as an initial step but the wet solids should then be collected in red bags before being transported for treatment and disposal. Cultures are collected in plastic bags. Except for the lack of color coding and biohazard marking, this is acceptable as long as the cultures are in closed glass containers and are not broken. Any glassware that is broken, has sharp edges, or may easily get broken (e.g., test tubes, slides, cover slips, pipettes, etc.) should be placed in puncture-resistant sharps containers. 4 Ii/1i of BIOM)e/ cii (t LI.StC '\ ILlI1Ligt'1110J11 PlJVl(r,Lc', No chemotherapy waste is generated in any of the facilities. Regular garbage is collected in garbage containers. Typically, one regular garbage container is placed near each bed. The numbers of regular garbage containers and of containers for potentially infectious waste seem appropriate for the size of the facility. Too many infectious waste containers have been shown to inflate unnecessarily the volume of waste as health care staff tend to discard regular garbage into infectious waste bins. However, sharps waste containers must be readily accessible to the staff. At Newtown Health Center, other types of waste such as bandages, cofton, gauze, etc. (except for sharps) are placed in trash containers and picked up and disposed of along with regular garbage. Blood-stained gauze at the Newtown Dental Clinic is segregated in separate containers and sent for disposal with regular garbage to the dumpsite. These are acceptable practices. A recent draft WHO report on biomedical waste health hazards notes that most blood-borne pathogens have a limited ability to multiple and remain viable longer than a few hours to a few days in dried blood ("Review of Health Impacts from Microbiological Hazards in Health-Care Wastes" (draft), I.F. Salkin; edited by M.E. Kennedy, World Health Organization, Geneva, 2001). Therefore, concerns with the handling of blood focus primarily on bulk liquid blood and the danger of blood splashes. In-house storage and transport: Biomedical waste is transported via an open trolley and brought directly to the incinerator on a regular basis. Fortunately, due to the relatively small amounts of waste generated daily, there is no need for a storage area for biomedical waste. The use of a trolley (Figure 4) that is open on the top and sides is generally not acceptable for transport of biomedical waste. A fully enclosed cart, with a lid to prevent spillage and avoid offensive sights and smells, is recommended for transporting biomedical waste. Until a fully enclosed cart is obtained, steps should be taken to minimize the possibility of spillage and the trolley should be regularly cleaned and disinfected. Figure 4. Open Trolley for Transporting Waste Regular garbage from the trash containers is dumped into a plastic bag twice a day and transported by trolley to a storage enclosure near the incinerator. It is recommended that a separate trolley be used for regular garbage. 7 b,ila ul /Jn1ne3I( m led [ 'l 'fuIuc A ,'flc1iC'meI PracLtrlc. Off-site transport: The Environmental Health Department schedules the removal of regular garbage from the hospital. A transport vehicle provides daily collection of garbage. Incinerator ash, treated sharps, and other waste are also collected and transported to the dumpsite. It is recommended that treated biomedical waste be kept separate from regular garbage so that the latter can be disposed of in a restricted area where waste recyclers or pickers are not allowed. . Waste Treatment Sharps waste, surgical and pathological waste, placenta waste, and cultures are sent to the incinerator for burning. At JNF Hospital, waste is treated in an old single-chamber oven-style incinerator (Figure 5) built around 1968 at the back of the hospital. The incinerator's stack was destroyed during Hurricane Georges in 1998. (A new chimney has been purchased.) The purpose of the chimney or stack is to disperse the pollutants higher up in the atmosphere thereby reducing pollutant concentrations at ground level. Unfortunately, the residences behind JNF Hospital where the incinerator is located are at a higher elevation and hence, the advantageous dispersion and dilution effects provided by a chimney are lessened. The incinerator is used approximately 4 days a week. Orderlies place the waste inside the chamber and light up the incinerator. Buming is initiated by adding logs to the waste, pouring kerosene on the waste pile, and using matches to ignite the pile. The orderlies are instructed to check periodically while the waste is burning. However, if cultures or tissue waste is burned, orderlies are told to monitor the burning. The incinerator is adjacent to the storage area for regular garbage. The ash and other residues from the incinerator are collected in a garbage bin and sent to the landfill approximately once a week. Figure 5. JNF Incinerator During Burning During the site visit, it was observed that emissions from the incinerator were generally blown in the direction of nearby residences and commercial facilities behind JNF Hospital. A single-chamber incinerator that is carefully maintained and operated properly should produce ashes containing less than 3 percent unburned matter. Debris was scattered in the area around the incinerator and burned or partially burned sharps waste could be found on the ground near the 8 -*lRi/U of BIo ehc( ol iWc\tC UWLQ1mgc1171 Pl-,Ien lce' incinerator (Figure 6). This creates an unsafe environment for orderlies and other workers dealing with biomedical waste and regular garbage that is stored adjacent to the incinerator. Figure 6. Partially Bumed Residues At one time, JNF Hospital had an autoclave but it malfunctioned. The hospital determined that the autoclave was irreparable and it was subsequently abandoned. Newtown Health Center has a small, unused single-chamber incinerator. Use of the incinerator was halted sometime in the mid-1990's due to the danger of fire or explosion as the incinerator is in close proximity to a Shell gas plant located adjacent to the clinic. The incinerator was used for less than a week. The safety concerns related to the gas plant are valid ones and the incinerator should not be used. Reportedly, Pogson Hospital and Mary Charles Hospital each have a small brick oven-type incinerator which one source described as "unapproved" designs. The current incinerator at JNF Hospital, even with a chimney, does not meet the basic criteria for good combustion and is a source of toxic air pollutants. The appearance of the residues indicates very poor combustion which, unfortunately, is inherent in these types of single-chamber designs. Research has shown that destruction of test spores take place when the waste is exposed to a minimum of 1,400 IF (760 IC) in a primary chamber and 1,600 IF (870 OC) in a secondary chamber with a 1.2 second residence time. Some regulatory authorities require a minimum temperature of 1,800 OF (980 IC) in the secondary chamber and a minimum 2-second residence time as a safety factor to assume total destruction of all pathogens. The single-chamber incinerator at St. Kitts does not meet this basic requirement. Steps should be taken to phase out the incinerator and replace it with a new treatment technology. 5. Waste Disposal The liquid portion of placenta waste is flushed down the sanitary sewer. As noted earlier, this is an acceptable method of disposal. 9 The Multi-Purpose Lab is consulted on how to dispose of expired or condemned pharmaceuticals; in general, they are bumed. The buming of pharmaceuticals results in the release of toxic air pollutants, as described above, and consequently, in potential adverse impact to public health and the environment. Spent solvents, such as xylenes and formaldehyde, are stored and disposed in the drain. This is not an acceptable disposal method since these toxic organic solvents could pollute the environment and possibly contaminate water sources. Waste from radiology (developers and fixatives) are neutralized and disposed in the sewer; there is no silver recovery system. This method of disposal into a public sewer system is commonly done and is acceptable as long as it is in keeping with any discharge permits or wastewater regulations. Since spent fixer solutions contain small amounts of silver (up to 1,400 parts per million), a silver recovery system may be considered if large amounts of wastewater are processed through radiology. The bumt sharps, ash, and other waste residues from the incinerator are brought to the Conaree site, a solid waste disposal area or dumpsite that is over 40 years old. There the waste is dumped along with regular garbage. Individuals can walk in but vehicles are checked at the gate. Dumping is supervised. Regular garbage is leveled and compacted by a bulldozer and an earth cover is added at the end of the day. Unusual waste that the hospital wishes to dispose of in a special manner (as well as occasional abattoir waste from the slaughterhouse) is buried in trenches in specially designated areas on the northwest side of the dumpsite. Recyclers or pickers actively scavenge and collect salvageable material from the landfill. Incinerator residues contain sharps and partially burned blood vials that pose needle-stick and bloodborne pathogen hazards to pickers. Those types of waste should be kept separate from regular garbage and pickers should not be allowed access to treated biomedical waste. Around 2002, the Conaree area will be the site of an engineered landfill to be constructed around the area where the current main entrance to the existing dumpsite is located. The development of an engineered landfill with restricted and marked areas for biomedical waste is recommended. 6. Employee Training At JNF Hospital, in-service training related to infection control was last conducted about two years ago. A teaching manual had been completed, including lesson plans and handouts. The instructions covered disinfection among other topics At present, little instruction on biomedical waste management is provided through informal, on-the-job training. In the future, some in-service training is planned to include waste handling. A nosocomial or infection control committee exists but has been dormant. It used to meet periodically. Unfortunately, staff attrition, in some cases due to study leave, resulted in the committee becoming inactive. One source noted that the committee could easily be revived since the organizational structure remains in place. 10 -1 o(B/I 0/B IflUL-Y I/CL/I It 1/4t' 1'JVC.IfLh1,0'11e07/1 PI-VL tL'c'C Despite the inexistence of govemment regulations, lack of implementation of hospital policies, and no formal employee training on waste management, many health care personnel demonstrated some understanding of the need to segregate at the point of generation and the importance of sharps waste management. Nevertheless, biomedical waste management should be a part of employee in-service training and an infection control committee, which plays an important role in biomedical waste management, should be fully reactivated. This will be discussed further in the Recommendations. Nevis: Biomedical Waste Management Practices 1. Policies and Procedures There are no written policies or guidelines for biomedical waste management at Alexandra Hospital. 2. Color Coding and Signage The following color coding had reportedly been used in the past: red bags for infectious waste, black for regular garbage. However, color coding is currently not used. As noted above, color coding and signage are important aspects of waste segregation for effective waste management, protection of public health, and occupational safety. They are generally accepted standards for handling health care waste. The lack of color coding and signage will be addressed in the Recommendations. 3. Waste Collection, Storage, and Transport At Alexandra Hospital, waste is segregated at the point of generation. Sharps waste is collected in two types of sharps containers: a small (tabletop) yellow plastic container (Vacutainer, volume of about 0.95 liters or 1 quart) and a larger red, horizontal-loading, rigid plastic container (Kendall, volume of about 7.6 liters or 2 gallons). These are shown in Figure 7. The use of rigid, puncture-resistant, and leak-proof containers for sharps is in keeping with generally recognized standards. Figure 7. Small Vacutainer (background) and Large Kendall (foreground) Sharps Containers .4'lI / ()I Biomleducii il WO'Wtc' AIUnc/Ict Iel i PI'(il L (cs Sharps containers were observed by the consultant in the medical/surgical ward, matemity, and laboratory. During the site visit, none of the sharps containers found was overfilled. The number of sharps containers relative to the number of regular garbage containers seems to be appropriate for this size of facility. As noted above, too many infectious waste containers tend to inflate unnecessarily the volume of waste but there must be sufficient sharps waste containers to be readily accessible to the staff. Details of infectious waste classification and segregation are discussed in the Recommendations. Blood collection tubes are collected in "Burn-up Bin" corrugated cardboard containers with translucent plastic liners (Figure 8). The cardboard bins have the biohazard marking on the outside. Pathological waste, placenta, and surgical waste are collected in plastic bags; the consultant observed dark green plastic bags inside red plastic containers for this purpose. Cultures and chemotherapy waste are not generated at the hospital. Regular garbage is collected in black bags inside garbage bins. 'CS' Figure 8. Burn-up Bin At Prospect Senior Citizen Home (long-term care facility), the staff noted that insulin needles were a concem in the past but not currently. At that time, the needles were wrapped in paper and discarded in the trash. For generators of very small amounts of sharps waste, such as households of insulin-dependent individuals or small long-term care facilities, it is recommended that the syringes be placed in a puncture-resistant container such as a hard plastic or metal can with a tightly secured lid and disposed with regular garbage. Sources reported that sharps waste is collected from clinics, transported by the Sanitation or Public Health Department, and disposed in trenches. Other sources indicated that animal carcasses from the two veterinary clinics (private and public facilities) are also buried in trenches. Waste Treatment At Alexandra Hospital, biomedical waste is burned in what had once been a single-chamber incinerator, shown in Figure 9. The incinerator was severely damaged by Hurricane Georges in 1998 so much so that less than half of the chamber remains standing. The incinerator essentially operates as an open-bum site. Waste is bumed once or twice a week or as needed. The Public Health Department picks up regular garbage and waste from the incinerator six days a week. Approximately three drums of waste are collected a day. 12 ,I fI(i of ))mLdlh (I f Il zc 'we 4L1a1n1qT?1Ciell PIVCrL C', Figure 9. Nevis "Incinerator" The "incinerator" at Alexandra Hospital cannot properly be classified as an incinerator. At the very least, an incinerator must have an enclosed combustion chamber. With this "incinerator," it is likely that not only toxic air pollutants but also pathogens are discharged to the air and left in the residues Furthermore, a possible scenario is that when Burn-Up Bins are burned, the integrity of boxes is destroyed by fire and blood collection tubes spill out to the ground with little or no exposure to high heat. The unburned or partially burned tubes break as they fall or are stepped on, thereby posing a serious risk of injury and spread of bloodborne pathogens. As mentioned earlier, many regulatory authorities have required a minimum temperature of 1,800 IF and a minimum 2-second residence time to assume total destruction of all pathogens. The single-chamber incinerator at Nevis falls far short of meeting this basic requirement. The 'incinerator" is a hazard and its use should be discontinued as soon as possible. A new biomedical waste incinerator has reportedly been purchased and will be installed. However, no details about the incinerator could be obtained during and after the consultant's site visit. 5. Waste Disposal Ash and other residues from the incinerator are placed in boxes and taken by the Public Health Department to the disposal site. The Low Ground dumpsite is in the area of Long Point. It has about five monitoring wells in place for the testing of leachate in the future. Construction of a sanitary landfill is expected to be completed in 2002. During the site visit, the consultant examined a trench (about 4 feet deep) intended for sharps waste. At that time, it contained abattoir waste (Figure 10). Adjacent to it was a smaller trench containing asbestos materials. The idea of a separate area for disposal of biomedical waste is a good plan. However, that area of the dumpsite must be separated by a fence or other barrier, marked with a warning sign to keep pickers out, and land disposal supervisors should be instructed to restrict access to the area. Note: Asbestos material, especially friable asbestos, is extremely hazardous. Microscopic asbestos fibers can be suspended in air and carried downwind. When inhaled, asbestos is known to cause lung cancer, mesothelioma, and asbestosis. The trench containing asbestos should be covered and marked permanently to prevent anyone in the future digging up or accidentally disturbing 13 411(/cI 0i Biom 1ed,c c I Lt/ c' .efl It Ll lcLste(M?I?el Pln (tL es the soil resulting in dangerous releases of asbestos. Anyone working on asbestos materials should wear personnel protection equipment including respirators designed for asbestos particles. ? Figure 10. Trench for Sharps and Abattoir Waste Expired pharmaceuticals in liquid form are discarded down the drain if the pharmacist deems them non-toxic. This is an acceptable procedure for small amounts of non-toxic waste. Injectables are snapped off, placed in boxes, and incinerated. Solid waste, such as expired tablets, is sent to the dumpsite. Disposal of condemned drugs is addressed in the Recommendations. 6. Employee Training There is no infection control committee and no employee training on biomedical waste management. Employee training is essential. An infection control committee plays an important role in the management of biomedical waste. This is addressed further in the Recommendations. 0 Notes on Recommendations Short-term recommendations are provided for immediate implementation to address imminent hazards and to protect health and the environment, and enhance worker safety. They may include some temporary measures as part of a transition to the full implementation of best practices and a national biomedical waste management system. Short-Term Recommendations: SHORT-TERM RECOMMENDATIONS FOR ST. KITTS: 0 All containers intended for potentially infectious waste should be marked with the intemational bio-hazard symbol in order to clearly distinguish between infectious and non-infectious waste. 14 'luI t 10 {RtIol,v / "a i d ( ' l'hZJh lI(.v 1"'I, rt( "C.( * The UNIVEC Safety Boxes should be replaced as soon as possible with puncture-resistant sharps containers. In the meantime, extreme care should be taken when placing sharps into UNIVEC boxes and when manually transporting boxes containing sharps waste. As soon as possible, specially designed sharps transport containers should be used by the health centers when transporting sharps waste from field immunizations. * All sharps containers should have lids to prevent accidental spillage. If rigid sharps containers are reused, the contents should be dumped directly into the incinerator chamber in a manner that would prevent needle-stick injury to the worker. The containers should then be cleaned and disinfected. * Any trolleys used to transport biomedical waste should not be used to transport regular garbage or other material. Orderlies should be instructed to minimize the risk of spillage. The trolley for biomedical waste should be cleaned regularly with soap and water, and disinfected with a bleach (sodium hypochlorite) solution. The open trolley should be replaced with a fully enclosed cart. * Steps should be taken to phase out the JNF Hospital incinerator as soon as possible. However, as long as the incinerator remains in use, the area around the incinerator should be kept clean. The chimney should be installed. The hospital should consult with a local meteorologist to determine the general time when the greatest air turbulence and dispersion happens during the day. Burning during this time period will help disperse toxic air pollutants and minimize local pollutant concentrations. Only potentially infectious waste should be incinerated. Sources of toxic metals (such as lead, mercury, cadmium, etc.) and chlorine (such as chlorinated plastics) should not be burned in the incinerator. It is essential to remove ashes, soot, slag, and bumed residues regularly in order to allow good air flow for combustion. The residues from the chamber and from the opening beneath the chamber should be collected directly into ash collection bins and not be allowed to scatter on the ground where they could pose a hazard. Orderlies should continue to monitor the incinerator to ensure as complete burning as possible. * Land disposal supervisors should ensure that recyclers or pickers are kept away from areas where treated waste from the incinerator is dumped. That section should have a physical barrier such as a fence and signs clearly marking the area as a restricted site. * The nosocomial or infection control committee at JNF Hospital should be reactivated. In addition to its other usual tasks, the committee should initially be responsible for the management of biomedical waste at the hospital. That responsibility can later be transitioned over to a Waste Management Team as explained further in the Long-Term Recommendations. 15 SHORT-TERM RECOMMENDATIONS FOR NEVIS: o All containers intended for infectious waste should be marked with the international biohazard symbol in order to clearly distinguish between infectious and non-infectious waste. o Use of the Alexandra Hospital incinerator should be halted immediately and a new treatment technology installed as soon as possible. Debris around the area of the burn site should be cleaned and sharps, blood collection tubes, and other residues should be collected in rigid containers and buried in deep trenches at the Low Ground dumpsite. o Until such time as a new treatment technology is available, sharps and other potentially infectious waste should continue to be segregated and transported regularly to the dumpsite where they should be buried in deep trenches and covered with earth. The area should be fenced in and marked with warning signs. They should remain segregated during transport and access to the trench areas should be restricted especially from recyclers or pickers. While this is not a preferred method of disposal, the consultant believes this method poses less of a hazard than using the broken incinerator. o The waste should be transported to a central collection point using a fully enclosed cart with a lid to prevent spillage and avoid offensive sights and smells. Orderlies should be instructed to minimize the risk of spillage. The cart should be used only to transport biomedical waste and should be cleaned regularly with soap and water, and disinfected with a bleach (sodium hypochlorite) solution. o An infection control committee should be formed at Alexandra Hospital. In addition to its usual role of developing and implementing policies, procedures, and programs to minimize the risk of spreading infection in the hospital, the infection control committee should initially be responsible for the management of biomedical waste. As explained in the Long-Term Recommendations, biomedical waste management should eventually be the responsibility of a Waste Management Team. Long-Term Recommendations for St. Kitts and Nevis 1. National Laws and Regulations Future legislation or regulations on biomedical waste management should consider the following elements: o Clear definitions of what constitutes biomedical waste and its categories o Cradle-to-grave approach to biomedical waste management o Coordination with hazardous (non-biomedical) waste management laws as well as other laws dealing with health (including prevention of infectious 16 I u Ir of Bionic' lIc I (I( {, it h r 1 . A YJ / l 2 .II_YMc II: j; , Xu tI, 'S diseases, hospital hygiene and infection control), sanitation, environment (air quality, water quality, land disposal), and occupational safety and health * Delineation of responsible national and local govemment authorities for implementation (usually the Ministry of Health has primary responsibility with the Ministry of Environment involved in specific ways) * Legal obligations of the biomedical waste generator * Provisions related to record-keeping and reporting * Provisions related to any fees for transport, treatment, and final disposal * Provisions related to inspections for the purpose of enforcement, penalties for non-compliance, and legal procedures for handling disputes related to enforcement. 2. Institutional Policy, Administration, and Organization Every hospital or health care facility should have a written policy on biomedical waste management. The policy should state the facility's objective of providing a system for management of biomedical waste in order to protect patients, staff, and the general public from hazards associated with biomedical waste. It should provide an overview of responsibilities and outline major procedures for biomedical waste management. A sample plan is provided in Appendix A3. Proper management of biomedical waste depends on good administration and organization. The waste management structure depends on the size and complexity of the facility. For JNF and Alexandra Hospitals, it is recommended that hospital waste management teams be established at both hospitals. Each team should be headed by the hospital administrator who is also the designated contact with the regulatory authority. The administrator should appoint one member of the team as the Waste Management Officer responsible for the day-to-day operation and monitoring of the waste management system. Because the Waste Management Officer must have access to all members of the hospital staff, it is important that the team include all department heads. Waste management will entail costs so the hospital's financial officer or accountant should also be part of the team. Therefore, the Waste Management Team should be comprised of: * Hospital Administrator (Chair of the Team) * Department Heads * Matron or Senior Nursing Officer * Infection Control Officer and/or Hospital Hygienist * Hospital Engineer or Maintenance Supervisor * Financial Officer or Accountant * Other staff (with relevant training or responsibilities) as needed The responsibilities of the Waste Management Team are: 1. To develop a written waste management policy, specific guidelines, and plan for implementation 17 41tu!ht o! Rion,-'C ' [dic (t!l ' AY,1ana(c,120 Pia( ru( '- 2. To review and revise (as needed) the policy, guidelines, and implementation plan on a periodic basis 3. To ensure adequate financial and human resources for efficient operation and monitoring of the plan. As mentioned, one of the above team members should be appointed the Waste Management Officer (this could also be the Infection Control Officer, Hospital Engineer, or Matron). The Waste Management Officer reports directly to the hospital administrator and should have direct access to all staff members. The responsibilities of the Waste Management Officer are: 1. To facilitate communications among members of the Waste Management Team to ensure that proper procedures are implemented, including timely intemal collection, emergency procedures, and reporting 2. To monitor and evaluate waste handling and disposal operations with the help of the Infection Control Officer; this may entail a comprehensive risk assessment of all activities with the help of other members of the team 3. To ensure that adequate supplies are available 4. To maintain records of the amounts and types of waste generated, accidents, unusual operational events, and non-compliance 5. To ensure that all staff members are aware of their responsibilities regarding biomedical waste and to work with the Infection Control Officer and other staff on the training programs 6. To identify items that need modification in the policy, guidelines, or plan. Other team members have responsibilities regarding biomedical waste: o The Department Heads and Matron should ensure that staff within their departments are familiar with the policy, guidelines, and plan, and have received training; they should also make sure any incidents are reported to the Waste Management Officer. o The Infection Control Officer should act as a technical consultant to the Waste Management Officer, participate in evaluating waste handling and disposal operations, and work with the Waste Management Officer and others in ensuring that the training program is implemented o The Hospital Engineer or Maintenance Supervisor should ensure that the maintenance or engineering staff receives training and should consult with the Waste Management Officer on matters dealing with the treatment technology. o The Financial Officer should consult with the Waste Management Officer on matters dealing with supplies and budgetary needs, and should investigate options to minimize waste or reduce toxicity through product * substitutions (e.g., using non-toxic substitutes for toxic solvents, replacing halogenated plastic disposables with non-halogenated equivalents, finding vendors willing to take back expired pharmaceuticals, etc.). 18 '1!I tu |l B(4 1(nn'"IIcdI Z :(L .1,'Iaaz7 -''uc m ; [it': CQs 3. Occupational Safety and Health Personal protective equipment should be made available to all personnel who handle, transport, and treat biomedical waste. Orderlies and other staff who pick up and transport biomedical waste should be provided with heavy-duty gloves, boots or shoes with thick soles, and coveralls. Gloves are essential to prevent lacerations, burns from hot surfaces (such as with a treatment technology), or contact with any chemical or biological material. Boots or shoes with thick soles and good traction should also be provided to protect from spilled sharps, chemicals, and slippery surfaces. Plastic coveralls provide protection from blood splatter and splashes from body fluids or chemicals. Leg protectors may be used in situations where the legs of waste workers may be in contact with waste bags. Health-care workers that deal in situations where they may be splashed with blood, body fluids, solvents, corrosive chemicals, or other hazardous liquids should be provided with eye and face protection. They should be used by staff members when discarding free-flowing blood and body fluids in the sanitary sewer. Immunization from viral hepatitis and tetanus is recommended for all waste handlers. Basic personal hygiene is also important and should be emphasized during training. Convenient washing facilities with warm water and soap should be available. 4. Waste Segregation and Classification Segregation, or the separation of specific types of waste from other types of waste, is key to effective management of medical waste. It is the responsibility of the waste generator. Potentially infectious waste should be segregated from regular garbage as close as possible to the point where the waste is generated. Segregation should be maintained during storage and transport up to the point of treatment. To be effective, the same system of segregation should apply throughout the country. There are many ways of classifying the different components of biomedical waste. In light of the types of waste produced in St. Kitts and Nevis, a simple classification is recommended in Table 1 focusing on the biomedical waste categories that pose the greatest hazards, as explained below. Sharps pose a potential disease transmission hazards because of their ability to create a portal of entry through the skin. In particular, needle-stick injuries are a known cause of the spread of infectious diseases and a serious occupational hazard. Cultures and stocks may contain high concentrations of disease-causing agents. Laboratory workers must use extreme caution to avoid inadvertent exposure to these pathogens and untreated cultures should be rendered noninfectious, preferably on site, prior to disposal. At present, there is no culture waste in Nevis. 19 o it IIew(,dwal, , 'I a 1ua, 1'mcjz ' i cC Table 1. Biornedical Waste Categories (CUassification I) Waste Description Examples Where Found Category Sharps Items that could cut Hypodermic needles, syringes, Nursing Stations, or puncture suture needles, scalpel and Laboratory, regardless of whether other blades, lancets, saws, Emergency Room, they are infected or knives, broken or unbroken Surgery, Matemity not glass, vials, tubes, pipettes, etc. Ward, Clinics Cultures and Cultures and stocks Human and animal cell cultures, Laboratory, Stocks of infectious agents stocks of etiologic agents, Microbiology and associated discarded live and attenuated biologicals vaccine or serum, culture dishes and other devices used to transfer, inoculate or mix cell cultures Human Blood, Free-flowing blood, Free-flowing blood or blood Patient Wards, Blood Products, components or components, semen, vaginal Surgery, and Body Fluids products of blood, secretions, cerebrospinal fluid, Laboratory, and specific body synovial fluid, pleural fluid, Emergency Room fluids pericardial fluid, pertitoneal fluid, amniotic fluid, saliva in dental procedures, and body fluids contaminated with blood Pathological Human pathological Tissues, organs, anatomical Surgery, Pathology, Waste waste waste (recognizable body parts Autopsy except teeth) removed during surgery, autopsy or other procedures Animal Waste Contaminated animal Animal carcasses, animal body Veterinary Hospitals waste parts, blood, body fluids, and and Clinics, bedding known to have been Research exposed to infectious agents Laboratories Selected Waste generated by Swabs, excreta, soiled Isolation Ward Isolation Waste patients who are dressings, drainage sets, items isolated to prevent saturated or dripping with human the spread of highly blood, etc. from patients infected communicable with highly communicable diseases diseases (see below) Inadvertent contact with blood through cuts or mucous membranes has been associated with the transmission of disease by blood-borne pathogens such as HIV and hepatitis B. The risk comes from contact with blood or body fluids in liquid form which is capable of splashing in the eyes or other mucous membranes. Most blood-borne pathogens have a limited ability to multiply or 20 ,Audt(l oIfl,owcdw"1al, J4'asc A'Iauagemni P1 a a remain viable longer than a few hours or a few days in dried blood. For this reason, the focus of concem is liquid blood. While pathological waste has not been generally implicated in disease transmission, it has potentially infective qualities. Moreover, there may be aesthetic, cultural, or religious factors that may determine how pathological waste is treated and disposed. In general, they can be treated in a treatment technology and buried in a sanitary landfill. Placentas and human fetuses can be interred in special burial sites. The main concern relating to animal waste would be animal carcasses that have been inoculated with infectious agents or any animals exposed to pathogens such as those that cause transmissible spongiform encephalopathies ("mad cow disease"). Regular abattoir waste is not included in this category. In many countries, isolation waste is only limited to wastes generated from patients infected with certain highly communicable diseases, specifically defined as Class 4 agents such as Ebola, Crimean hemorrhagic fever, Lassa fever, Marburg, etc. The hospital's infection control committee should determine whether waste from specific isolation rooms should have special handling, treatment, and disposal. Table 2. Additional Waste Categories (Classification II) Waste Category Description Examples Where Found Pharmaceutical Discarded items Expired, condemned, or Pharmacy Waste containing contaminated pharmaceutical pharmaceuticals products Chemotherapeutic Waste containing Chiorambucil, Daunomycin, Cancer Therapy Waste cytotoxic, Melphalan, Mitomycin C, genotoxic, or other Uracil mustard, Streptozotocin, hazardous Cyclophosphamide, etc antineoplastic drugs Low-level Waste containing Pipettes, vials, syringes, Nuclear Medicine, Radioactive radioactive needles, gloves, absorbents, Clinical and Waste substances etc. contaminated with Research radionuclides Laboratories Other Hazardous Waste that exhibit Xylene, methanol, Formalin Nursing Stations, Chemical Waste hazardous (formaldehyde solution), Pathology, characteristics trichloroethylene, sulfuric acid, Autopsy, Dialysis, (corrosive, ignitable, glutaraldehyde, mercury from Radiology, chemically reactive, broken thermometers, spent Laboratory, toxic) in addition to batteries, cleaning solvents, Facility wastes already degreasers, potassium Engineering & classified above cyanide, asbestos, PCBs, etc. Maintenance, Funeral Homes 21 -41U(1I f)fl3medi( a/ 11 teItc A1an,agcmenl PIYIUh,LC' There are other classifications that either fall under the hazardous waste category (which in some countries is defined and regulated separately from infectious waste) and others that may not apply at this time but may describe biomedical waste streams in the future. The additional classifications are shown in Table 2. At present, there are no chemotherapeutic and low-level radioactive wastes in St. Kitts and Nevis. 5. Waste Minimization It is recommended that all health-care facilities institute a waste minimization program. Waste minimization is the reduction, to the extent possible, of waste that is destined for ultimate disposal. Potential benefits of minimization include: environmental protection, enhanced occupational safety and health, cost reductions, reduced liability, and improved community relations. The following are basic techniques of waste minimization: source reduction (including material substitution, process changes, and good practices), resource recovery and recycling, and composting. Some basic concepts of waste minimization and recommended resources are provided in Appendix A4. 6. Labeling, Color Coding, and Signage Every container for infectious medical waste must have the intemational biohazard symbol in a contrasting color painted or affixed to the container as shown in Figure 11. (Note: The dot in the middle is not part of the symbol; it is used to center the marking if needed.) L~~. Figure 11. International Biohazard Symbol In addition to the symbol, one of the following warning signs should be painted or marked on the container, whichever is appropriate: o "Biohazard" o "Sharps" or "Biohazard" (for sharps containers) 22 The following color-coding is recommended: Table 3. Color Coding TYPE OF WASTE COLOR OF BAG OR CONTAINER Potentially Infectious Waste RED Sharps RED Washable Contaminated Linen YELLOW Chemical, Pharmaceutical, or BROWN Chemotherapeutic Waste Regular garbage TRANSLUCENT Signage in the form of posters displayed in public areas is helpful, not just as a reminder to health care staff, but also to inform patients and the public about the facility's waste management system. A sample poster is shown in Appendix A5. 7. Waste Collection Potentially infectious waste should be segregated in clearly marked containers that are appropriate for the type of waste, as shown below. Table 4. Collection Container Specifications TYPE OF WASTE SPECIFICATIONS FOR CONTAINER OR BAG Sharps - Container should be puncture-resistant, leak-proof on the sides and bottom, durable, and closable (closure should be secure) - Container should be labeled and color-coded - Container should be designed so that it is easily and safety determined when the container is nearly full Non-sharps - Container should be leak-proof, rigid, durable, labeled, and color infectious waste coded (solid/semi-solid) - Plastic bag should be leak-proof, designed to prevent ripping, tearing, or bursting under normal use, labeled; and color coded The plastic bag should be placed inside a rigid container Non-sharps - Container should be leak-proof and durable infectious waste - Container should be designed such that it can be transported (liquid) without spillage Appropriately sized sharps containers should be placed in locations easily accessible to personnel and as close as possible to the immediate area where sharps are used. Examples include phlebotomy area, treatment and examination rooms, nursing stations, operating rooms, emergency rooms, etc. To prevent injuries, needles should not be recapped nor removed from disposable syringes. Sharps containers should not be overfilled. A ngid, puncture-resistant plastic sharps container specifically designed for needles and syringes is recommended. A reusable container is acceptable as long as the container and its contents can be disinfected in a treatment technology and the sharps can be removed safely. A reusable container should be cleaned on a routine basis. A bleach bottle with the biohazard symbol and "Caution: Sharps" marking in red is acceptable as a container for blood collection tubes. 23 -1 ud if 0I i3uu a;('h I ; 1t in A 'IC it P-; , C.t iICC The Waste Management Officer should regularly monitor sharps collection containers to ensure that they are not overfilled, that full containers are promptly removed, that non-sharps waste are not placed in sharps container, that enough sharps containers are available and located in appropriate locations, and that new staff members are educated on sharps disposal practices. The Waste Management and Infection Control Officers should document any needle-stick injuries due to sharps collection, assess why the injury took place, and take steps to prevent future injuries. 8. Handling and Transport Within the Facility Personal protective equipment (PPE) should be worn dunng any operation where there is a potential for exposure. PPE included gloves, gowns, masks, face shields, and/or safety goggles or glasses, depending on the operation. Fully enclosed, wheeled carts should be used when transporting waste through the facility to a storage area or treatment technology. Carts used for potentially infectious waste should be used only for that purpose. They should be cleaned and disinfected on a routine basis. 9. Transport Outside the Facility Transport of untreated infectious waste outside any health-care facility should be regulated by the Ministry of Public Health and/or the Ministry of Environment. This should involve a cradle-to-grave approach to manage and account for biomedical waste and entail a medical waste tracking system. The waste generator (hospital or health-care facility) is always responsible for ensuring that its medical waste reaches the off-site destination facility, such as a waste treatment center or sanitary landfill. Health centers and other small facilities should use special care when transporting sharps waste. Small amounts of sharps waste may be transported in fully enclosed transport pouches specifically designed for such purposes. Infectious waste should be transported in leak-proof, fully enclosed containers or vehicle compartments that are secured when unattended and designed to prevent spillage or leakage during transport. If the vehicle is used for other waste, the infectious waste containers or vehicle compartments should be separated by barriers from the other types of waste. The waste should be labeled with the biohazard symbol. The vehicle should have identification markings or placards on the sides and back. In keeping with intemational standards, the placard should be diamond- shaped with black inscription on a white background. The upper half of the diamond-shaped placard should have the intemational biohazard symbol, the lower half should have the words "INFECTIOUS WASTE" and "IN CASE OF ACCIDENT IMMEDIATELY NOTIFY PUBLIC HEALTH AUTHORITY' and at the very bottom, the number "6" which is the intemational hazard identification number for toxic or infectious hazards. 24 411(11! of B:on",;c'dca,l PI ot. 11' Al , ;,c ij,i1', (U:?,,. The transporter or hauler should have contingency plans in the event of spills or accidents during transport. 10. Waste Treatment The JNF Hospital incinerator should be replaced with a more effective and cleaner treatment technology with minimal impact on public health and the environment. Likewise, the Alexandra Hospital incinerator should be replaced at the soonest possible with an effective and cleaner treatment technology with minimal impact on public health and the environment. Recommendations on a waste treatment technology for St. Kitts are presented in a separate report entitled "Review and Recommendation on a Medical Waste Treatment Technology." The waste categories listed under Classification II (expired pharmaceuticals, chemotherapy waste, low-level radioactive waste, and other hazardous chemical wastes) are those that require special handling as hazardous waste. Some of those waste streams are currently not found at St. Kitts and Nevis but they may be generated in the future. This section provides recommendations for those waste streams. Four procedures are recommended for pharmaceutical waste: (1) Return of expired pharmaceuticals to supplier, (2) Inertization, (3) Encapsulation, and (4) Sewer discharge. Many healthcare facilities around the world now have arrangements with pharmaceutical companies to send back expired or condemned drugs. This is the preferred method of handling this waste stream. Another altemative is inertization: Solid pharmaceutical waste is removed from packaging or containers, ground up and then mixed with cement, lime, and water. The following ratio is recommended: 65% pharmaceutical waste, 15% lime, 15% cement, and 5% water. The homogeneous mixture is allowed to harden into cubes or pellets. The hardened mass should then be disposed in a hazardous waste landfill engineered to prevent groundwater contamination. In the absence of a hazardous waste landfill, the hardened mass may be disposed in a restricted portion of the sanitary landfill or buried in specially designed trenches or burial pits within the health-care facility premises. In the latter case, the trenches or pits must be lined with clay or a membrane liner to prevent leaching into groundwater, secured with a fence to restrict access, and eventually capped to prevent percolation of water. A waste minimization program should be in place so that only small amounts of pharmaceutical waste are disposed of in this manner. A third altemative is encapsulation: Solid, semi-liquid, or liquid pharmaceutical waste could be placed in drums which are filled to 3/4ths their capacity. The drums are then filled with cement mortar or clay, sealed, then buried in a hazardous waste landfill engineered to prevent groundwater contamination. Again, in the absence of a hazardous waste landfill, the sealed drums may be buried in a restricted area of the sanitary landfill. As with inertization, a waste minimization program should be in place so that only small amounts of pharmaceutical waste are disposed of in this manner. 25 A fourth alternative applies only to moderate quantities of relatively mild liquid or semi-liquid pharmaceuticals such as vitamin solutions, cough syrups, eye drops, saline solutions, intravenous fluids, etc. It is acceptable to discharge these liquid drugs into a sanitary sewer while diluting with large amounts of water. Antibiotics and chemotherapy drugs should not be discharged into the sanitary sewer. Chemotherapeutic wastes are either bulk agents or materials, such as vials or gloves, contaminated with trace amounts of chemotherapy agents, also called antineoplastic agents or cytotoxic drugs. Examples of these cancer therapy drugs are Chlorambucil, Cytoxin, Daunomycin, Mitomycin C, Streptozotocin, Melphalan, and Uracil Mustard. They require special handling procedures because of their toxic characteristics. Many regulatory agencies allow the disposal in a sanitary landfill of trace-contaminated waste. However, it is recommended that trace-contaminated waste be encapsulated (placed in drums filled to 3/4ths their capacity, then filled with cement mortar or clay, and sealed) and buried in hazardous waste landfills or restricted sections of a sanitary landfill engineered to prevent groundwater contamination. There are two recommended procedures for bulk chemotherapy waste: (1) Return to supplier and (2) Chemical degradation. Bulk quantities of chemotherapy agents should be repackaged, marked 'outdated" or "not for use", and returned to the supplier. Chemical degradation methods exist for chemotherapy agents. These methods are relatively safe and simple. They involve oxidation by potassium permanganate or sulfuric acid, denitrosation by hydrobromic acid, reduction by nickel and aluminum, or hydrolysis using heated alkali. The Unit of Gene-Environment Interactions of the Intemational Agency for Research on Cancer (IARC, 150 Cours Albert-Thomas, 69372 Lyon Cedex 08, France) is a source of information for chemical degradation methods. Chemical degradation can also be used to clean up spills or contaminated urinals. Although incineration is a treatment method used for chemotherapeutic waste, it should be noted that the destruction of chemotherapy drugs can only be accomplished in specialized dual-chamber incinerators operating at very high temperatures, typically above 2,200 OF (1,200 OC) with a minimum residence time of 5 seconds. Three disposal methods are recommended for low-level radioactive waste: (1) Decay in storage or "storage for decay", (2) Return to supplier, or (3) Long-term storage at an authorized radioactive waste disposal site. Radionuclides with short half-lives are generally stored for a period (typically ten times the half-life of the longest lived radionuclide in a container) to allow decay to background levels as confirmed by a radiation survey, then disposed as regular waste. Decayed but infectious waste should be disinfected before disposal. Facilities should segregate radioactive waste according to the length of time needed for storage: short-term storage (half-lives less than 30 days) and long-term storage (half-lives from 30 to 65 days). Storage facilities must be secure and designed to limit human exposure. A radioactive waste management plan should include a program of waste minimization. Source reduction may be achieved by limiting the quantity of radioactivity purchased, using non-radioactive materials or shorter- lived radionuclides where possible, and designing laboratory procedures to reduce the volume of mixed waste. 26 l / lu " )l'lto ('l( fl al(Mh' *} I /:l / I, ' PI; a( :i ''( For large sealed sources or sources containing long-lived radionuclides, the waste should be retumed to the producer or supplier of the original material. It is recommended that any health-care facility planning to import a sealed source with a radioactivity greater than 100 MBq 10 years after receipt should require the supplier to accept the source back after expiration of its useful lifetime and within a year after a return request is made. If this is not possible, the waste must be stored in an approved long-term storage facility in keeping with international guidelines. Whether the waste is returned or stored in a long-term facility, the waste should first be conditioned to make it suitable for handling, transportation, and storage. Conditioning may involve immobilization in concrete, securing the waste in suitable containers, and/or providing special packaging. Other hazardous chemical waste includes spent organic solvents, degreasers and oils used by the engineering staff, mercury from broken thermometers, etc. Four disposal methods are recommended: (1) Return to supplier, (2) Chemical degradation, (3) Encapsulation and disposal in a hazardous waste landfill, or (4) Sewer discharge. Appropriate provisions may be included in the original purchase contract of chemicals to allow the return of spent or outdated chemicals to the original supplier in a country with the expertise and facilities to dispose of the waste safely and in an environmentally sound manner. Shipment for the purpose of returning the waste should comply with international agreements including the Basel Convention. It may be possible to degrade or neutralize some chemical waste (e.g., acids or bases) at a special treatment facility. If neither of these altematives is possible, the chemical waste should be encapsulated in small quantities in drums and buried in an approved hazardous waste landfill engineered to prevent groundwater contamination. Large amounts of disinfectants should not be encapsulated as they are corrosive and sometimes flammable. Hazardous chemical wastes of different compositions should be stored separately to avoid unwanted chemical reactions. Some mild chemicals, such as mild disinfecting or cleaning solutions, may be discharged in the sanitary sewer while diluting with large amounts of water. Examples of ways to minimize hazardous chemical waste are provided in Appendix A6. Final Disposal Liquid blood and body fluids should be discharged directly and carefully into a sanitary sewer using personal protective equipment (gown, goggles, face shield or mask). Hands should be washed thoroughly after gloves are removed. The facility should check to make sure any effluents to the sanitary sewer are within specified regulatory limits, if any, for wastewater discharges. In general, treated biomedical waste can be sent along with regular garbage for final disposal to a sanitary landfill constructed with a clay or geomembrane liner such as high-density polyethylene to prevent groundwater contamination. If, for some reason, untreated medical waste has to be disposed of in the landfill or if treated sharps have not been destroyed to the point of eliminating needle-stick injury hazards, a special trench or cell can be used for this purpose. Unauthorized entry to the area should be prevented by restricting access, constructing fences, and posting signs such as "BIOHAZARDOUS WASTE 27 4.1(h/ i!b P:li ca l C t 'I,t1.1 ,; ,ct,r t, i1 c 'S AREA - UNAUTHORIZED PERSONS KEEP OUT'. However, the preferred method is treatment followed by final disposal. 12. Summary of Blomedical Waste Management Proceduires The tables in the following pages outline in a simplified form the main recommended procedures for segregating, transporting, treating, and disposing of biomedical waste. Regular garbage is included for the purpose of comparison. A separate table is presented for waste categories under Classification 11. 13. Contingency Planniing Health-care facilities should develop contingency plans in the event that biomedical waste is spilled, a worker is injured, or the treatment technology is down for repairs. For clearing up spillage of blood, body fluids, chemicals, or other potentially hazardous substances, personal protection equipment such as gloves and coveralls are needed. If there is any risk of splashing, eye protectors and masks should also be wom. The appropriate respirators may be needed if toxic vapors or dust are involved. Solid residues should be recovered using hand tools such as shovels. If potentially infectious waste is involved, the floor should be cleaned and disinfected after most of the waste has been recovered. All health-care staff should be trained to deal with injuries and exposures. In the event of an injury, first-aid measures should be applied followed by additional medical attention as needed. With needle-stick injuries, bleeding of the wound should be encouraged and the area washed and cleaned thoroughly. Blood or other tests may be indicated, as well as prophylactic treatment. Medical monitoring and incident reporting are important parts of contingency planning. Department heads and other members of the Waste Management Team should encourage prompt and accurate reporting for the purpose of ensuring proper medical attention and prophylaxis, and to identify remedial actions to prevent injuries in the future. Incident reporting should not be seen as punitive. Medical monitoring programs are specifically designed to evaluate the extent of workplace exposure or the effects of known exposures to workers' health. If the treatment technology is shut down for repair or periodic maintenance, facilities should have altematives, such as long-term storage areas and/or arrangements with other facilities to transport and treat their biomedical waste at other sites. 28 d1uo(11/ lo,; ic' ( (L '°' B'ofhZt' P" a 1' Table 5. Recommended Procedures for JNF Hospital, St. Kitts Facility JNF Hospital Waste Sharps Cultures & Blood & Pathological Waste Isolation (Contamin Regular Type Stocks Body Waste ated Garbage Fluids Linen) Examples Needles, Culture Free- Tissues, Placentas, Swabs, Bedding Garbage Syringes, dishes flovwng Body Parts Fetuses Soiled Blood Blood Dressing Tubes Color Red Red Red Red Red Red Yellow Trans- Code lucent Marking Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard none Symbol, Symbol, Symbol, Symbol, Symb. Symbol, Symbol, "Sharps" 'Biohazard 'Biohazard" 'Biohazard" 'Biohazard" 'Biohazard" "Biohazard" Packaging Puncture- Plasbc Bag Leak-proof Plastc Bag Plashc Bag Plasbc Bag Plastc or Plasbc Resistant in a Rigid Container in a Rigid in a Rigid in a Rigid Linen Bag Bag or Sharps Container Container Container Container Container Container In-House Covered Covered Covered Covered Covered Covered Covered Trolley or Transport Cart Cart Cart Cart Cart Cart Cart cart not for bio- medical waste Storage Protected Protected N/a Protected Protected Protected N/a Regular Endosure Enclosure, Endosure, Endosure, Enclosure, storage 4°Cor39 4°Cor39 4°Cor39°F 4°Cor39 area OF ' I °OF* . OF Treatment Automabc Advanced Discharge Advanced Bunal or Advanced Wash in N/a Needle Autoclave Into Autodave Advanced Autoclave Hot Water Destroyer, Sanitary Autodave (160 OF or Advanced Sewer 88 OC) for Autodave 20 minutes Off-Site Special Special N/a Special Specal Special N/a N/a Transport Vehicle Vehicle Vehicle Vehicle Vehilde (untreated waste) _ Off-Site Sanitabon Sanitabon N/a Sanitabon Sanitabon Sanitabon N/a Sanitabon Transport Truck Truck Truck Truck Truck Truck (treated waste) Disposal Sanitary Sanitary Sanitary Sanitary Interment in Sanitary N/a Recyding Landfill Landfill Sewer Landfill Bunal Site or Landfill or Sanitary Sanitary Landfill Landill N/a=not applicable, 'Recommended practce if storage bme is long enough to result in putnd smells from decaying organic waste (e g , more than 48 hours) 29 4I Lh/ Rio; 'C(i1 (. w I \ 1 .1/ i c-'fl;c i1; I -)i ul( 1l('' Table 6. Recommended Procedures for Pogson HospftW, Mary Charles Hospital, and Health Centers, St. Kitts Facility Pogson Hospital, Mary Charles Hospital, and Health Centers Waste Sharps Blood & Body Fluids Placenta or Fetuses Regular Garbage Type Examples Needles, Syringes, Blood Free-flowing Blood Garbage Tubes Color Code Red Red Red Translucent Marking Biohazard Symbol, Biohazard Symbol, Biohazard Symbol, none 'Sharps 'Biohazard" 'Biohazard" Packaging Puncture-Resistant Sharps Leak-proof Container Plastc Bag in a Rigid Plastc Bag or Container Container Container In-House Covered Cart Covered Cart Covered Cart Trolley or cart not for Transport biomedical waste Storage Protected Enclosure N/a Protected Enclosure, 4 OC Regular Storage Area or 39 OF * Treatment Automabc Needle Discharge Into Sanitary Bunal or Advanced N/a Destroyer, Advanced Sewer Autoclave Autodave Off-Site Speaal Vehide or N/a Speaal Vehide Sanitabon Truck Transport Transport Pouch (untreated waste) Disposal Sanitary Landfill Sanitary Sewer Interment in Bunal Site or Recycling or Sanitary Sanitary Landfill Landfill N/a=not applicable, *Recommended practce if storage bme is long enough to result in putnd smells from decaying organic waste (e g , more than 48 hours) 30 'lad/aI o)/ i:fl:U,/if fl 1 A /d7zdQI'ilt ll /-i,.< "It I' Table 7. Recommended Procedures for Alexandra Hospital, Nevis Facility Alexandra Hospital Waste Sharps Blood & Pathological Waste Isolation (Contamina Regular Type Body Fluids Waste ted Linen) Garbage Examples Needles, Free-flowing Tissues, Body Placentas, Swabs, Bedding Garbage Synnges, Blood Parts Fetuses Soiled Blood Tubes Dressing Color Red Red Red Red Red Yellow Trans- Code lucent Marking Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard none Symbol, Symbol, Symbol, Symbol, Symbol, Symbol, 'Sharps' 'Biohazard" "Biohazard" 'Biohazard' 'Biohazard" 'Biohazard" Packaging Puncture- Leak-proof Plasbc Bag in Leak-proof Plastc Bag Plashc or Plasbc Bag Resistant Container a Rigid Container in a Rigid Linen Bag or Sharps Container Container Container Container In-House Covered Cart Covered Cart Covered Cart Covered Cart Covered Covered Trolley or Transport Cart Cart cart not for biomedical waste Storage Protected N/a Protected Protected Protected N/a Regular Endosure Endosure, 4 Endosure, 4 Enclosure, 4 storage °C or 39 OF * OC or 39 OF OC or 39 OF * area Treatment Automabc Discharge Treatment Bunal or Treatment Wash in Hot N/a Needle Into Sanitary Technology Treatment Technology Water (160 Destroyer, Sewer Technology OF or 88 OC) Treatment for 20 Technology minutes Off-Site Special Vehide N/a Speaal Special Special N/a N/a Transport Vehide Vehicle Vehicle (untreated waste) Off-Site Sanitabon N/a Sanitabon Sanitabon Sanitabon N/a Sanitabon Transport Truck Truck Truck Truck Truck (treated waste) Disposal Sanitary Sanitary Sanitary Interment in Sanitary N/a Recycling Landfill Sewer Landfill Bunal Site or Landfill or Sanitary Sanitary Landfill Landfill N/a=not applicable, 'Recommended practce if storage bme is long enough to result in putnd smells from decaying organic waste (e g, more than 48 hours) Note. Sinoe no informabon was obtained regarding the new incinerator to be able to evaluate its capabilibes, the treatment technology for Nevis is not specified. 31 Table 8. Recommended Procedures for HeaDth Centers, Nevis Facility Health Centers Waste Sharps Blood & Body Fluids Regular Garbage Type Examples Needles, Synnges, Blood Tubes Free-flowing Blood Garbage Color Code Red Red Translucent Marking Biohazard Symbol, 'Sharps Biohazard SymbO, none "Biohazard' Packaging Puncture-Resistant Sharps Container Leak-proof Container Plastc Bag or Container In-House Covered Cart Covered Cart Trolley or cart not used for Transport biomedical waste Treatment Automabc Needle Destroyer, Treabnent Disciarge Into Sanitary Sewer N/a Technology Storage Protected Endosure N/a Regular Storage Area Off-Site Speaal Vehide or Transport Pouch N/a Sanitabon Truck Transport Disposal Sanitary Landfill Sanitary Sewer Recyding or Sanitary Landfill N/a=not applicable Table 9. Recommended Procedures for Other Types of Waste (Classification 11) Facility All Waste Expired Chemotherapy Waste Low-Level Radioactive Other Hazardous Chemical Type Pharmaceutirals Waste Waste Examples Condemned drugs Chlorambucil, Cytoxin, tnbum, iodine-125, carbon- Formaldehyde, Uracil Mustard 14, radium-226 tnchloroethylene, xylenes Color Brown Brown Brown Brown Code Marking "Hazardous Waste" Biohazard Symbol, Radiabon Symbol, "Hazardous Waste' 'Biohazard" 'Radioactve Waste" Packaging Rigid, Leak-proof Rigid, Leak-proof Rigid, Leak-proof Rigid, Leak-proof Containers Containers Containers Containers In-House Covered Cart Covered Cart Covered Cart Covered Cart Transport Storage Protected Enclosure Protected Enclosure Conditioned Waste, Secure Protected Enclosure Storage Facility with Radiological Protecton Off-Site Special Vehide Speaal Vehide Speoal Vehide Speaal Vehicle Transport Treatment Retum to Supplier, Retum to Supplier or Decay in Storage, Retum to Retum to Supplier, Chemical & Disposal Inertzabon, Chemical Degradabon Supplier, or Long-Term Degradabon, Encapsulabon Methods Encapsulabon, or (for bulk agents), Storage (depending on half- and Disposal in Hazardous Sewer Discharge Encapsulabon (for life of radionuclide) Waste Landfill, or Sewer (depending on type of trace-contaminated Discharge (depending on I_________ drugs) waste) type of waste) 32 'I Jh ll 0/ ih(,n 'C'( l'IC (ai I 0.$1.' W a .i':1z./ -mc ni , 1c 14. Employee Training and Public Education Employee training and public education are key components of biomedical waste management. The objectives of training and education are: 1. To prevent occupational and public exposure to infectious waste and related health hazards 2. To foster responsibility among health care workers regarding medical waste management 3. To create awareness and educate patients and visitors about the risks related to medical waste and elicit their cooperation in preventing exposure. It should be the responsibility of the Waste Management Officer and Infection Control Officer to ensure that training programs and annual refresher courses or seminars take place. Formal training of all health care personnel on biomedical waste management is critical for a successful waste management program. Training can be in the form of staff workshops, seminars, in-service training, or classroom-type instruction. Separate training activities can be tailored and targeted to three different groups in a health care facility: * Administrative managers and clerical staff * Medical doctors, nurses, lab technicians, and other health care professionals * Cleaners, porters, waste handlers, and other auxiliary staff General employee training programs should include the following: * Overview and rationale of the health care facility's policy on waste management and the objectives of the policy * Roles and responsibilities of each staff member in implementing the policy * Risks associated with medical waste, the basic elements of infection, and the importance of safe practices * Waste classification * Procedures for waste minimization * Procedures for waste segregation including labeling and color coding * Overview of the fate of medical waste after collection: handling, storage, transport, treatment, and final disposal * General cleaning, disinfection, and contingency procedures for spills and accidents. 33 -I,I1(;t hi e q ni e m ln i (Wak1t Van1)tlQ(',/C ii J-T('u UC'2 o Reporting procedures for accidental exposures to infectious waste (needle-sticks, blood splashes, etc.) or improper collection, handling, or treatment practices. For health care providers, the following additional precautions should be emphasized: o Special care has to be taken when dealing with sharps waste. Sharps containers should not be overfilled. Needles should not be manually removed from syringes. o No attempt should be made to remove items from an infectious waste bag or container. If an infectious waste item is accidentally placed in a regular garbage bag, the entire mixture should be treated as potentially infectious waste. o Hazardous chemicals, such as mercury and formaldehyde, and pressurized containers such as aerosol cans, should not be mixed with potentially infectious waste. Waste handlers and treatment technology operators should receive specialized instruction. In addition to the above topics, training programs for them should also include: o Specific procedures for handling, including identifying the types of waste in bags and containers through their colors and labels; when to seal bags; how bags are sealed; how bags are picked up and deposited; how bags should be carried; procedures for handling sharps containers; and ergonomic issues. o Specific procedures for storage (if needed) and transport of medical waste, including how to keep waste segregated, loading and unloading bags, and the proper use of carts o Safe practices and use of protective equipment such as gloves and footwear o Emergency response to spills and other accidents o General operating principles of the treatment technology o Occupational safety, health, and environmental issues related to the treatment technology o Specific technical procedures for the operation and monitoring of the treatment technology, including the loading and unloading of waste, start- up and shut-down procedures, understanding equipment monitoring data, and the use of controls o Emergency response to equipment alarms and failures, including how to detect abnormal conditions and malfunctions o Maintenance procedures related to the treatment technology o Removal of residues from the treatment technology 34 ,Autdi 0! B,o n,10n ,'ic t4l W PId,hW,,-g c II ,,,i , rIa( i1c Public education may be done through the placement of posters (see for example Appendix A5), handouts, and/or verbal instruction to patients and visitors explaining the facility's color coding and labeling system. Importantly, patients and visitors should be instructed: (1) not to place regular garbage into red, yellow, or brown bags or containers marked with the intemational biohazard symbol, (2) not to open or handle any biohazardous waste containers, (3) to keep children away from any biohazardous waste containers, and (4) to report any spills or accidents involving a biohazardous waste container immediately and to refrain from touching any of the spilled contents. 35 APPENDIX Al: Sources of Infonmnaton The following facilities were visited between November 13 to 15, 2001: 2. Joseph N. France General Hospital, Basseterre, St. Kitts 3. Newtown Health Center, St. Kitts 4. Newtown Dental Clinic, St. Kitts 5. Conaree Dumpsite, St. Kitts 6. Alexandra Hospital, Charlestown, Nevis 7. Low Ground Dumpsite, Nevis 8. Prospect Senior Citizen Home, Nevis The consultant met with the following individuals between November 13 to 15, 2001: 1. Mr. Elvis Newton Permanent Secretary, Ministry of Health & Environment, St Kitts and Nevis 2. Mr. Clifford Griffin Senior Officer, Ministry of Health, St Kitts 3. Ms. Launette Adams Operations Manager JNF Hospital, St. Kitts 4. Mrs. Jean Condor Director of Health Institutions 5. Ms. Agnes Beachman Nursing Consultant, JNF Hospital, St Kitts 6. Mr. Collin Mulley Biomedical Technician Engineer, JNF Hospital, St. Kitts 7. Mrs. Jasmin Hanley Manager, Laboratory, JNF Hospital, St. Kitts 8. Ms. Ena Sutton Infection Control and Quality Assurance Manager, JNF Hospital, St. Kitts 9. Mr. Robert Bowry Manager, Central Medical Supply 10. Mr. Joel Patrick Radiographer, JNF Hospital, St Kitts 11. Mr. Halvon Hendrickson Orderly, JNF Hospital, St Kitts 12. Sr. Gannett Maternity, JNF Hospital, St. Kitts 13. Mrs. Sylvia Isaac Co-coordinator, Community Health Services, Ministry of Health, St Kitts 14. Mr. Oliver Lawrence Chief Environmental Health Officer, Ministry of Health, St. Kitts 15. Mr. Carlton Frank Senior Environmental Health Officer, Ministry of Health, St. Kitts 16. Mr. Alphonso Bridgewater Manager, Solid Waste Management Corporation, St. Kitts 17. Mr. Warrington Chapman Education Officer, Solid Waste Management Corporation, St. Kitts 18. Mrs. Rhonda Lowry-Robinson Nurse-in-Charge, Newtown Health Center 19. Dr. Nayan Bhandary Dentist, Newtown Dental Clinic 20. Mr. Theodore Mills Manager, Solid Waste, Nevis 21. Mr. St Clair Wallace Permanent Secretary of Health, Nevis 22. Dr. Cuthwin Lake Superintendent and Health Advisor, Alexandra Hospital, Nevis 23. Mrs. Loraine Hanley-Browne Supervisor, Public Health Nurse, Ministry of Health, Nevis 24. Mr. George Meade Maintenance, Alexandra Hospital Nevis 25. Mr. Bernard Liburd Maintenance, Alexandra Hospital Nevis 26. Mrs. Veta A. Morton Laboratory Technician, Alexandra Hospital, Nevis 27. Mr. Adrian Douglas Student Laboratory Technician, Alexandra Hospital, Nevis 28. Mr. Earl Dowd Maintenance Technician, Alexandra Hospital, Nevis 29. Ms. Myma Webbe Avalon Medical Laboratory, Nevis 30. Dr. Janardhan Vathada Dental Surgeon, Nevis 31. Mr. Stedroy Williams Senior Public Health Inspector, Nevis 32. Ms. Joselyn Liburd Administrator, Alexandra Hospital, Nevis 33. Ms. Viola Martin Assistant Matron, Alexandra Hospital, Nevis 34. Mr. Loston Nisbett Pharmacist, Alexandra Hospital, Nevis 35. Mrs. Adriene Stanley Nursing Sister, Alexandra Hospital, Nevis 36. Ms. Simone Hill Nurse, Alexandra Hospital, Nevis 37. Mr. Andie Jn.Panel OECS, St. Lucia The following documents were obtained during and after the site visit: 1. Inventory of Health Centers St. Kitts and Nevis, prepared by Ms. Sylvia Isaacs, 8 November 2001; provided by Mr. Clifford Griffin, Ministry of Health. 2. List of doctors and pharmacies in St. Kitts and Nevis, facsimile copy dated 7 November 2001; provided by Mr. Clifford Griffin, Ministry of Health. 3. "Waste Disposal Policy and Procedure," JNF Hospital, St. Kitts (undated). 4. Lesson Plan #2, Infection Control Education and Annual Review; Weekly Update form, Infection Control; Field Audit form, Infection Control; and Patient Audit form, Infection Control; forms and sample lesson plan provided by Ms. Agnes Beachman, Nursing Consultant, JNF Hospital, St. Kitts. 5. 'Bio-Medical Waste Management Plan: St. Christopher and Nevis," Draft Report, CBCL Limited Consulting Engineers, prepared for OECS, February 2000. 6. 'The Solid Waste Management Bill, 2000," Saint Christopher and Nevis. 7. Electronic mail from Mr. Clifford Griffin, 23 November 2001. A1-2 About a hundred digital photographs were taken during the site visits. Below are brief descriptions and the number of photographs obtained: 1. Incinerator and storage area, JNF Hospital - 4 2. Various waste containers, JNF Hospital - 9 3. Large garbage collection bins, Long Point - 2 4. Long Point Dump Site - 12 5. Various waste containers, Alexandra Hospital - 8 6. Incinerator and surrounding area, Alexandra Hospital - 8 7. Waste containers in the Laboratory, Alexandra Hospital - 6 8. Waste containers in the medical/surgical ward, Alexandra Hospital - 2 9. Waste container, Prospect Center - 1 10. Waste containers, Microbiology, JNF Hospital - 3 11. Close-up of sharps container, JNF Hospital - 4 12. Waste trolley, JNF Hospital - 2 13. Conaree Dump Site - 20 14. JNF Hospital entrance - 3 15. Incinerator and storage area, JNF Hospital - 8 16. Waste disposal, Radiology, JNF Hospital - 3 17. Regular garbage bin - 1 18. Waste containers and unused incinerator, Newtown Clinic - 8 19. Waste containers, Newtown Dental Clinic - 6 20. Abattoir facility - 1 A1-3 Audit of Medical Waste Management Pmctices APPENDIX A2: Waste Disposal Policy and Procedure-JNF General Hospital Purpose: To eliminate the potential hazard to patients, staff and the general public from potentially infectious waste Policy: All hospital waste matenal will be disposed of in one of three (3) different coloured bags- clear, red or yellow. In addition, all sharps will be disposed of in red or yellow sharps contamers * Clear bags: for all non-contaminated waste * Red bags: for all potentially mfectious waste * Yellow bags: for all trace chemotherapeutic waste * Red puncture-resistant containers: for all discarded sharps, except trace chemo sharps Patient areas ill require red bags only in soiled utility rooms, treatment/utlity rooms, medication rooms and patient rooms with highly contagious conditions (NOT T.B., HIV) such as Ebola, Lassa Fever. Responsibility All patent contact staff: distinguish types of waste and place in proper containers/bags Laboratory: Proper disposal of lab waste Pathology: Prepare pathological waste for transfer m appropriate containers Housekeepmg. Collection and transport of all waste matenals, prepare for delivery to on-site treatment and destruction (routine pick up or mcmeration) Waste Disposal Methods Categorn Material Disposal Method Bag/container Pathological All Areas All human tissue, carcasses and on-site incinerator hand-delivered in bedding exposed to pathogenic containers or bags to organisms pathology Laboratory Clinical All matenals - solids and Autoclaved on site Red autoclave bag Microbiology liquids (e.g., bactenal, viral or with indicator fungal culture specimens In tightly lidded or stoppered non- glass contamers, petri dishes) Culture in glass containers Autoclaved on site Red autoclave bag e.g. blood culture bottles with indicator discard in puncture resistant red contamers A2-I Audit ofMedical Waste Management Practices All pasteur pipettes, blood vials, on site treatment and Puncture-resistant red Test tubes, slides, cover slips, destruction containers broken or unbroken glassware in contact with infectious agents Clinical, All specimens from patients on site treatment and Red bags Pathological and with highly comrnunicable destruction Research (other diseases (clots, sera, etc.) than Cl. Micro) All bactenal, viral or fungal autoclave on site autoclave red bag with culture matenal In non-glass indicator then discard containers in red bag Culture in glass containers autoclave on site as above, then puncture-resistant red containers Other glassware in contact with on site treatment and puncture resistant red mifectious agents destruction containers Sharps That which will cause puncture on site treatment and puncture resistant red or cut, i.e., All needles, synnges, destruction containers blades, lancets, pasteur pipettes, blood vials, test tubes, slides, cover slips, broken or unbroken glassware In contact with mfectous agents Sharps Chemo as above used in chemotherapy on site incuineratnon Yellow puncture- resistant containers Biological Liquids: excretion, exudates, Sewer - discard liquid discard container into (patient care Areas) secretions, suctionings m non- in utility sink, hopper, clear bag sealed containers bedpan flushes or Toilet (never dispose in Handwashing suiks) Solids and disposable medical regular waste disposal Clear bags supplies in contact with patient system (except tubing), e.g., disposable towels, gown, apron, underpads, gloves, masks, clamps, electrodes A2-2 Audit of Medical Waste Management Practices APPENDIX A3: Sample Institutional Policy Purpose: To provide a system for management of biomedical waste in order to protect patients, staff, and the general public from hazards associated with biomedical waste Responsibilities: All staff must be familiar with the policy, guidelines, and implementation plan and participate in training dealing with biomedical waste management. Department Heads and Matron should ensure that staff within their departments are familiar with the policy, guidelines, and plan, and have received training. The Waste Management Officer is responsible for day-to-day implementation and monitoring of biomedical waste management. The Waste Management Team is responsible for the policy, guidelines and plan. Policy: Occupational Safety: Appropriate personal protective equipment must be used when dealing with biomedical waste. Waste handlers will receive immunization from viral hepatitis and tetanus. Waste Minimization: The institution is committed to minimizing the impact of our waste on the environment. Staff members are responsible for participating in waste reduction and recycling programs. Classification: The following categories of waste are considered biomedical waste and must be handled cautiously as biohazardous or hazardous waste: sharps; cultures and stocks; human blood, blood products, and body fluids; pathological waste; animal waste; selected isolation waste; pharmaceutical waste; chemotherapy waste; low-level radioactive waste; and other hazardous chemical waste. Segregation: Biomedical waste will be segregated throughout the facility. Segregation should take place at or as close as possible to the point where the waste is generated, and segregation should be maintained during storage and transport up to the point of treatment. Labeling and Color Codinq: Every container for infectious biomedical waste must have the international biohazard symbol in a contrasting color painted or affixed to the container, along with the words "Biohazard" or "Sharps" whichever is appropriate. The following color coding will be used: TYPE OF WASTE COLOR OF BAG OR CONTAINER Potentially Infectious Waste RED Sharps RED Washable Contaminated Linen YELLOW Chemical, Pharmaceutical, or BROWN Chemotherapeutic Waste I_I Regular garbage TRANSLUCENT A3-1 Audit of Medical Waste Management Practices Red bags will be available in treatment rooms, surgical suites, emergency room, nurses' stations, and isolation rooms. Sharps containers will be available in medical and surgical wards, laboratory or phlebotomy stations, nurses' stations, treatment rooms, emergency rooms, and other areas easily accessible to personnel near the area where sharps are used. Collection, Storage, Transport, and Treatment: The procedures for biomedical waste management are summarized in the tables in the next two pages. Training: Formal training will be provided to all health-care personnel on biomedical waste management. Staff is required to attend the in-service training or workshops and refresher course. Contingency Planning: Copies of the institution's contingency plans for waste spillage or other emergencies are found in . Staff should be familiar with the contingency plan. Spills will be managed by the housekeeping staff under the supervision of the Waste Management Officer. Reporting: Any incidents such as biomedical waste spills, needle-stick punctures, or other injuries associated with biomedical waste should be reported immediately to the Waste Management Officer (name ). A3 -2 Audit ofAledical Waste Management Practces SUMMARY OF BIOMEDICAL WASTE MANAGEMENT PROCEDURES Waste Sharps Cultures & Blood & Pathological Waste Isolation (Contamin Regular Type Stocks Body Waste ated Garbage Fluids Linen) Examples Needles, Culture Free- Tissues, Placentas, Swabs, Bedding Garbage Synnges, dishes flowmng Body Parts Fetuses Soiled Blood Blood Dressing Tubes Color Red Red Red Red Red Red Yellow Trans- Code lucent Marking Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard none Symbol, Symbol, Symbol, Symbol, Symbol, Symbol, Symbol, "Sharps" 'Biohazard 'Biohazard" 'Biohazard' 'Biohazard' 'Biohazard' 'Biohazard' Packaging Puncture- Plasbc Bag Leak-proof Plastc Bag Plastc Bag Plastc Bag Plasbc or Plastc Resistant in a Rigid Container in a Rigid in a Rigid in a Rigid Linen Bag Bag or Sharps Container Container Container Container Container Container I In-House Covered Covered Covered Covered Covered Covered Covered Trolley or Transport Cart Cart Cart Cart Cart Cart Cart cart not used for biomed- ical waste Storage Protected Protected N/a Protected Protected Protected N/a Regular Endosure Endosure, Endosure, Endosure, Enclosure, storage 4 IC or 39 4 OC or 39 4 OC or 39 OF 4 OC or 39 area OF * OF * OF *_. Treatment Automabc Advancod Discharge Advanced Bunal or Advanced Wash in N/a Needle Autodave Into Autoclave Advanced Autodave Hot Water Destroyer, Sanitary Autoclave (160 OF or Advanced Sewer 88 °C) for Autoclave 20 minutes Off-Site Special Special N/a Speaal Speoal Special N/a N/a Transport Vehicle Vehide Vehicle Vehicle Vehicle (untreated waste) Off-Site Sanitaton Sanitabon N/a Sanitabon Sanitafion Sanitabon N/a Sanitaton Transport Truck Truck Truck Truck Truck Truck (treated waste) Disposal Sanitary Sanitary Sanitary Sanitary Interment in Sanitary N/a Recycling Landfill Landfill Sewer Landfill Burial Site or Landfill or Sanitary Sanitary Landfill Landfill *If storage bme is long enough to result in putnd smells from decaying organic waste A3-3 Audit of Medical Waste Management Practices SUMMARY OF BlOME=iICAL WASTE GANAGEMlEMT [PROCEDSIURES (Continued) Waste Expired Chemotherapy Waste Low-Level Radioactive Other Hazardous Chemical Type Pharmaceuticals Waste Waste Examples Condemned drugs Chlorambual, Cytoxin, tntium, iodine-125, carbon- Fomaldehyde, Uradl Mustard 14, radium-226 trichlomethylene, xylenes Color Brown Brown Brown Brown Code Marking 'Hazardous Waste" Biohazard Symbol, Radiation Symbol, 'Hazardous Waste" 'Biohazard" 'Radioactive Waste" Packaging Rigid or Leak-proof Rigid or Leak-proof Rigid or Leak-proof Rigid or Leak-proof Containers Containers Containers Containers In-House Covered Cart Covered Cart Covered Cart Covered Cart Transport Storage Protected Enclosure Protected Endosure Condiboned Waste, Secure Protected Enclosure Storage Facility with Radiological Protection Off-Site Special Vehide Speaal Vehide Spedal Vehide Special Vehide Transport Treatment Retum to Supplier, Retum to Supplier or Decay in Storage, Retum to Retum to Supplier, Chemical & Disposal Inertzabon, Chemical Degradabon Supplier, or Long-Term Degradabon, Encapsulabon Methods Encapsulabon, or (for bulk agents), Storage (depending on half- and Disposal in Hazardous Sewer Discharge Encapsulabon (for life of radionudide) Waste Landfill, or Sewer (depending on type of trace-contaminated DLscharge (depending on drugs) waste) type of waste) A3-4 Audit o/Medical Waste Management Pmclces APPENDIXA4: Waste Minimizaton Waste minimization is the reduction, to the greatest extent possible, of waste that is destined for ultimate disposal, by means of reuse, recycling, and other programs. The potential benefits of waste minimization are: environmental protection, enhanced occupational safety and health, cost reductions, reduced liability, regulatory compliance, and improved community relations. The following is the recommended hierarchy of waste minimization techniques in order of decreasing preference: 1. Segregation - making sure waste items are in the appropriate container. Staff training is essential to keep regulated medical waste, hazardous waste such as mercury, low-level radioactive waste, and regular trash separated from each other. 2. Source reduction - minimizing or eliminating the generation of waste at the source itself; source reduction should have a higher priority than recycling or reuse. Users, waste managers, and product standardization committees should be aware of what waste is generated by the products they buy. Source reduction requires the involvement of purchasing staff. Steps should be taken to reduce at the source regulated medical waste, hazardous waste, low-level radioactive waste, as well as regular trash. Some specific source reduction techniques include: a. Material elimination, change or product substitution, e.g., substituting a non-toxic biodegradable cleaner for a cleaner that generates hazardous waste; employing multiple-use instead of single-use products; using short-lived radionuclides instead of radium-226 needles in cancer treatment b. Technology or process change, e.g., using non-mercury- containing devices instead of mercury thermometers or mercury switches; using ultrasonic or steam cleaning instead of chemical- based cleaners c. Good operating practice, e.g., improving inventory control; covering disinfecting solution trays to prevent evaporative losses; using the minimum formulation recommended for an application d. Preferential purchasing such as selecting vendors with reduced packaging 3. Resource recovery and recycling - recovery and reuse of materials from the waste stream. Some specific examples include: a. Recycling newspapers, packaging material, office paper, glass, aluminum cans, construction debris, and other recyclables b. Purchasing products made of post-consumer recycled material c. Composting organic food waste A4-1 Audit ofMed,cal Waste Management Practices d. Recoverng silver from photographic chemicals 4. Treatment - treatment to remove and concentrate waste, preferably in process rather than end-of-pipe treatment. An example might be the use of filters and traps to remove mercury from wastewater. 5. Proper MDsposal - when all possible waste minimization options have been exhausted, the remaining waste should be disposed in the method with the least environmental impact. The commitment of top management, active involvement of individuals from different departments, communication, and educational programs are essential to a successful waste minimization program. APPROACHES TO WASTE MINIMIZATION There are four basic stages in the development of a waste minimization program. These are: planning and organization, assessment, feasibility analysis, and implementation. The initial stage of planning and organization entails getting healthcare management to be committed to waste minimization (reflected in a formal policy statement), setting overall goals, and staffing a task force to get key personnel from affected departments involved. The assessment phase begins with the collection of data regarding waste streams, processes and operations which are sources of these wastes, types of practices and process control, waste analysis, information on input materials, and economic information. A medical waste analysis (described below) is a valuable tool for the assessment phase. Flow diagrams and material balances are useful in identifying sources and attempting to quantify losses or emissions. It may be necessary to prioritize waste streams based on quantity, toxicity, environmental impact, potential liability, regulations, cost, and other factors. An assessment team of selected staff people with the assistance of outside consultants should review the data, inspect specific areas of waste generation, come up with waste minimization altematives, and screen and select options for study. With regards to municipal solid waste, the assessment team needs to determine the recyclability of materials. In the feasibility analysis phase, a technical and economic evaluation is conducted of the selected options. Among the criteria for technical evaluation are worker safety, maintaining quality of product or service, compatibility with existing operating procedures and work schedules, minimal disruption to install a new system or process, space availability, etc. The economic evaluation uses standard measures of comparative analysis such as payback period, retum on investment, and net present value. The final phase is implementation. This entails obtaining funding, education and communications programs, installing new equipment or initiating new procedures, and evaluating the performance. A demonstration may be necessary to evaluate A4 -2 Audit of Afedical Wf/aste Management Practices an option before final installation. Education and communications programs are essential. They must be designed to reach out to the entire staff, tap existing channels of education, provide education on a continuing basis especially for new staff, and respond to feedback from employees. There are various measures to determine the effectiveness of waste minimization. The initial method is to simply compare recorded quantities of waste generated before and after implementation. However, since waste generation may be dependent on rate of operation, the ratio of waste generation rate to some measure of rate of operation (such as number of occupied beds per day) is another way to analyze waste reduction. Another measure is to analyze the waste minimization project's impact on the institution's cash flow which may reflect reduced cost for waste management and raw materials. In some instances, waste reduction may be expressed in terms of the ratio of input material consumption to rate of operation. These measurements are complicated by processes or services that generate waste infrequently or intermittently, and some evaluation methods may be more appropriate to specific units in the facility rather than the entire facility. MEDICAL WASTE ANALYSIS A medical waste analysis or assessment can provide data on the sources of waste, compositions, generation rates, and waste flow within the facility. Medical waste analysis involves preparation, data collection, analysis, and recommendations. Preparation entails defining goals, planning, enlisting the cooperation of key personnel and department heads, and a preliminary "walk- through" of the facility. Data can be collected in-house using self-audit forms and questionnaires. Another approach is to employ an outside consultant. The need for representative sampling determines the time period for data collection. Data collected for a few days provides a snapshot of the waste flow. Collecting data for two or more weeks requires greater staff effort but it may reveal important variations during different days of the week. A third approach is to install a computerized waste tracking system for long-term data collection. A "waste sort" (separating and weighing components of waste collected during a time period) provides a more detailed analysis of waste composition and requires personal protective equipment. From the data, one establishes the flow of waste and generation rates of every unit of the facility. Data on waste composition can be used to evaluate classification and segregation practices. Over-classification (treating non- infectious waste as infectious waste) and lack of segregation (commingling regular waste with infectious or hazardous waste) add significantly to treatment and disposal costs. A waste analysis can uncover inefficiencies, estimate the true costs of waste management, and establish the levels of compliance to policies. Waste analysis is essential in waste minimization as well as in related goals such as developing recommendations for cost reduction, improving compliance, and reducing risk and liability. A4-3 Audti ofMedical Waste Management Practices SUGGESTED WASTE MINIMIZATION OPTIONS Some suggested waste minimization methods for different types of waste are summarized below. The table shows the areas in a hospital where recyclable solid waste is generated and the types of common recyclables found. The health-care facility may have to explore and negotiate with firms to accept materials for reuse and recycling or to help develop markets for recyclables. Sources and Types of Common Recyclable Waste in a Hospital Sources OCC N MG WP C CPO AVIM G P P P P P other P p 1 2 5 6 P ShippinglRecvg x x x x x x 1 Food Service x x x x x x 2 Laboratory x x x x x x x x Pabent Care x x x x x x x x x x Admin Offioes x x x x x x Radiology, CT x x x x x x 3 Surgery x x x x x x x x Pharmacy x x x x x x Dialysis x x x x x x Doctors Offices x x x x x Medical Records x x x x x Housekeeping x x x 4 Faolity Mgt x x x x 5 Public Areas x x x x Hospital-wide 6 Legend. OCC - corrugated cardboard packaging; NP - newspaper, MG - magaanes; WP - white office paper, CP - colored ledger paper, CPO - computer pnntout paper (greenbar, bluebar); AV/M - aluminum and metal beverage, food, and other cans, G - glass including dear glass; P1 - PETE plastcs (soda bottles); P2 - HDPE (milk jugs, dialysis solubons, food stuffs, deaning solubons), P5 - polypropylene (sterile irrigabon fluid bottes), P6 - polystyrene (food service and supply packaging); PP - polystyrene (Styrofoam) packaging peanuts; Other. 1 - stretchw rap; 2- grease, organic food waste, aerosol cans; 3-film, silver recovery, 4 - aerosol cans, 5 - wood, aerosol cans, construction & demolibon debns, palettes. 6 - other recydables found hospital- wide indude durable goods such as fumishings, clipboards, old computer equipment, desks, drapes, mattresses, carpets, binders, dishware, phone directones, pnnter cartndges, etc. [Source An Ounce of Prevenion: Waste Reduction Strategies for Health Care Facilities, C.L Bisson, G. McRae, and H.G. Shaner, Amencan Society for Healthcare Environmental Services (Amencan Hospital Assoaabon), Chicago, Illinois, 1993.] An extra effort needs to be invested in segregating recyclable from non-recyclable waste. The facility should develop an intemal system for collecting paper, glass, aluminum, and other recyclables. This may entail investing in recycling equipment and collection containers. There may be recycling and waste-hauling companies who could provide recycling services. In addition to paper, glass, and aluminum recycling, other ideas for recycling include: identifying markets for plastic waste which comprise a significant percentage of solid waste from hospitals; recycling or proper disposal of batteries; special recycling programs for bulky materials (old mattresses, furniture, stretchers, etc.); and recycling of construction and demolition waste. There may be opportunities for recycling of scrap aluminum, wallboard, wood, metal piping, wiring, etc. Another major potential for hospitals is composting to recycle organic wastes such as food, yard, and wood fiber (low-grade paper and boxboard) scraps. The purchasing departments of healthcare facilities play a major role in 'closing the loop" by seeking out and purchasing products made mostly of postconsumer recycled material. They can also reduce waste generation by purchasing goods A4 -4 Audit of Medical Waste Management Practices for their durability and "reprocessability," selecting products with minimal packaging, and working with supplier to support waste minimization. A product management approach can identify opportunities for reducing waste through purchasing, inventory control, changes in packaging, and working with suppliers. RESOURCES Many resources are available to assist health care organizations develop an effective waste minimization program in their facilities (see box insert). Books such as Guidebook for Hospital Waste Reduction Planning and Program Implementation, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, and The Waste Not Book provide valuable information and practical suggestions. RECONlMENDED READINGS ON WASTE MINIMIIZATION Waste minimization model plans and guides including a chemical waste minimization plan, mercury-virtual elimination plan, and gulde to environmentally-preferable purchasing Hospitals for a Healthy Environment (an Amencan Hospital Association and U S Environmental Protection Agency partnership) (available at wkvw h2e-online or,) On-line resources on waste minimization for hospitals and laboratones, Minnesota Technical Assistance Program (MnTAP), University of Minnesota, School of Public Health, Division of Environmental and Occupational Health (wv%'w mntap umn edu ) Waste Almuniziation in the HealtJhcare Industro A Resource Guide. J Emmanuel, EPRI, Palo Alto, CA 1999 TR-1 13841 (EPRJ, 3412 Hillview Avenue, Palo Alto, CA 94303, 800-313-3774) Environmental Managemnent in Healthicare Facilities, Edited by K D Wagner, C.D Rounds, and R Spurgin, W B Saunders Company, Philadelphia, Pennsylvania, 1998 (W B Saunders Company, The Curtis Center, Independence Square West, Philadelphia, PA 19106, 800-545-2522, http llwww harcounhealth conv) Guidebook for Hospital Waste Reduction Planning and Prograni Implementation, Glenn McRae and Holhie Gusky Shaner, RN, Amencan Society for Healthcare Environmental Services (Amencan Hospital Association), Chicago, Illinois, 1996 (AHA Secvices, Inc, P O Box 92683, Chicago, IL 60675-2683, 800-AHA-2626) An OUaIce ofPrevention Waste Reduction Strategiesfor Health Care Facilities, C.L. Bisson, G McRae, and H G Shaner, Amencan Society for Healthcare Environmental Services (Amencan Hospital Association), Chicago, Illinois, 1993 (AHA Services, Inc, PO Box 92683, Chicago. IL 60675-2683, 800-AtHA-2626) Tle 1Waste A'o Book, Public Affairs Division, Minnesota Hospital Association, Minneapolis, Minnesota, 1993 (Minnesota Hospital and Healthcare Partnership, 2550 W University Avenue, Suite 350-S, St Paul, MN 55114-1900, 800462-5393, www mhhp com) "Facility Pollution Prevention Guide," EPA/600/R-92/088, U S Environmental Protection Agency, Risk Reduction Engineenng Laboratory, Off-ice of Research and Development, Cincinnati, Ohio, 1992 1 "Hospital Pollution Prevention Study," EPA/600/2-91/024, prepared by R Linen for DeparTment ofVeterans Affairs, Washington, DC, and Risk Reduction Engineenng Laboratory, Office of Research and Development, Cincinnati, Ohio, July 1991 * "Guides to Pollution Prevention Selected Hospital Waste Streamns" (formerly titled "Guide to Waste Minimization in Selected Hospital Waste Streams"), EPA/625/7-901009, U S Environmental Protection Agency, Risk Reduction Engineenng Laboratory, Cincinnati, Ohio. June 1990 * "Waste Minimization Opportunity Assessment Manual," EPA/625/7-88-003, U S Environmental Protection Agency, Hazardous Waste Engineenng Research Laboratory, Cincinnati, Ohio, 1988 * ( Contact EPA Publications at 800490-9198 or check out littp lvww epa gov/epahome/publicatioits htm for EPA reports) A4-5 Audit ofMedical Waste Management Practtces APPENDIXA5: Sample Poster HOSPITAL WASTE I MANAGEMENT SYSTEM | BIONMEDICAL WASTE ailising from direct patient care r~~ _ FOUL & INFECTED LINEN 4- CHENMOTHERPAPY, _IW - ~ PHARMACEUTICAL & CHEMICAL WrASTE REGULAR TRASH A5 -1 Audit of Medical Waste Management Practices APPENDIX A6: Ideas for Hazardous Waste Minimization WASTE TYPES SOME HAZARDOUS WASTE MINIMIZATION IDEAS Solvents Recover/reuse solvents through on-site or off-site distillation; e g., use fractional disbillation to separate xylene from ethanol in histology waste Substitute less hazardous solvents, use non-halogenated for halogenated compounds, and simple alcohols and ketones for petroleum hydrocarbons; use aqueous reagents whenever possible. Consider commercial xylene substitutes as histology solvents. Use pre-mixed kits for tests involving solvent fixabon. Use high-resolubon analytical equipment to reduce analyte test volumes. Use calibrated solvent dispensers for routine tests. Minimize sizes of cultures and specimens in pathology, histology and labs. Formaldehyde Use reverse osmosis water treatment to reduce dialysis cleaning demands. wastes Minimize strength of formaldehyde solubons. Develop standards for Formalin solutions based on microbial culture studies to determine minimum cleaning frequency and solubon concentrabons. Investigate possible reuse of formaldehyde in pathology and autopsy. Use a chemical addibve that reacts with and cross-links waste formaldehyde solutions to form a non-hazardous end product. Antneoplastic Substtute degradable drugs for environmentally persistent drugs. agents Optimize drug container sizes in purchasing and buy according to need. Retum outdated drugs to manufacturers. Minimize the cleaning frequency and volume of gauze matenal used for the compounding hood. Provide spill cleanup kits and employee training. Photographic Recover silver using cabon exchange and electrolytic recovery instead of steel wool chemicals filtration units. Ensure proper storage conditions to increase shelf life and test expired material for usefulness; retum off-spec developer to manufacturer. Cover developer and fixer tanks to reduce evaporabon and oxidation; consider adding ammonium thiosulfate to fixer or an acetic acid bath prior to fixing to extend life of fixing bath; use squeegees to reduce bath losses. Recycle spoiled film and paper. Use countercurrent washing. Use a chemical additive that neutralizes spent fixer and developer waste and permanently binds silver to a solid matnx. Mercury wastes Subsbtute electronic sensing devices and other non-mercury substitutes for mercury- containing devices Provide mercury spill cleanup kits and train personnel. Completely drain residual mercury from medical devices and consider off-site recycling of uncontaminated mercury. Disinfecting Use ultrasonic or steam cleaning instead of alcohol-based disinfectants. solubons Keep disinfecting solution trays and containers well covered to avoid loss by evaporation. Use a chemical addibve that reacts with and cross-links glutaraldehyde wastewater to form a non-hazardous end product Maintenance and Use ultrasonic or steam cleaning instead of aqueous or chemical-based cleaners, use utility wastes biodegradable cleaners instead of solvent-based cleaners. Collect waste oil and solvents for recycling; segregate recyclable oils and solvents from non-recyclables. Replace oil-based paints with water-based paints. Use only required pesticide quantties or use non-chemical pesticide control methods. [Source: 'Guides to Pollution Prevenbon: Selected Hospital Waste Streams," EPA162517-90/009, U.S. Environmental Protection Agency, Risk Reducton Engineering Laboratory, Cincinnati, Ohio, June 1990.] A6-1 IE & ER Group E & ER Group Phone 510-799-2551 628 Second Street Fax 510-799-2572 Rodeo, CA 94572 USA MCOV I I adKe,U RIImmmetn d az~%t'H.1n ra- eicaiW Waste Treate TachnoHogyAlwl St. Kitts and Nevis Prepared for: Natural Resources Management Unit (NRMU) Organization of Eastern Caribbean States (OECS) January 18, 2002 Table of Contents Executive Summary .............. ..........................i Introduction ........................................... Objectives ..1 Types of Biomedical Waste Treatment Processes ........1 Selection Criteria ............ ............................3 Screening of Treatment Technologies ............................7 Comparison of Advanced Autoclaves and Incinerators .........................................9 Summary: Tabulated Comparisons ............................... 20 Potential Impact of the Stockholm Convention ........... 21 Recommendation ............. .......................... 21 Cost Estimates for an Advanced Autoclave ................. 22 Appendix Tender Specifications for an Advanced Autoclave Treatment Technology ....................................... B1 Operating Procedures, Preventive Maintenance, Training Requirements, and Periodic Verification Testing of Treatment Technology ............................ B2 EXECUTIVE SUMMARY This report presents a review of available biomedical waste treatment technologies and makes recommendations for St. Kitts. The possible location of the technology will be explored with stakeholders. There are basically four processes involved in treating biomedical waste: thermal, chemical, irradiative, and biological processes. Screening criteria include size (throughput rate), level of commercialization, cost of the technology, and ability to meet international environmental standards. These criteria are used to initially screen 49 specific technologies resulting in the selection of two commercially available advanced autoclaves. The final selection considers a range of other factors including space, utility, and installation requirements, occupational safety, noise, odor, level of automation and ease of use, skill and training required to operate the technology, reliability, maintenance, and availability of technical support. A major portion of the report compares advanced autoclaves with incinerators. Comparisons focus on environmental issues, public and occupational health impacts, pathogen destruction, and costs. The possible ramifications of the newly completed Stockholm Convention on Persistent Organic Pollutants on medical waste incineration are also discussed. Comparisons of an advanced autoclave and incinerator are summarized in tabular form. Recommendations are made to replace the JNF Hospital incinerator with an advanced autoclave, in particular, the San-l-Pak 230-3P Auto-Clave system. Costs estimates are presented. Tender specifications can be found in the Appendix. Operating procedures, preventive maintenance, training requirements, and periodic validation testing are discussed in the Appendix. INTRODUCIION This project is a component of a larger World Bank-funded program to address the problem of solid and ship-generated wastes with the goal of protecting the environment and enforcing the MARPOL 73f78 Convention. The program involves six members of the Organization of Eastern Caribbean States (OECS) and is coordinated by the Natural Resources Management Unit of OECS. This particular component of the project deals with the management of health-care waste and has four specific tasks: (1) an audit of medical waste management practices, (2) review of existing medical waste treatment technologies, (3) development of a national biomedical waste management plan, and (4) a training program/implementation and monitoring. This report corresponds to the second of the aforementioned four tasks. The report was prepared by Dr. Jorge Emmanuel of the E & ER Group based in Rodeo, California, USA. The author is grateful to Mr. Clifford Griffin of the Ministry of Health and Mr. Theodore Mills for their invaluable assistance during his first visit. He also acknowledges the support of Permanent Secretaries Mr. Elvis Newton and Mr. St Clair Wallace, as well as Ms. Nona Adams of JNF Hospital and all the personnel who provided information at facilities in St. Kitts and Nevis. Jorge Emmanuel, PhD, CHMM, PE, REP, DES President, The E & ER Group 628 Second Street Rodeo, CA 94572 USA Ph 510-799-2551 Fax 510-799-2572 E-mail: iemmanuelC_mindsprinq com RLi'c'(Iaelndl RcLommneandation on a . Ied(/I( *al F1 ,.t. 7; e(Itfl T itne Tt'cIh dg,Io,' Review and Recommendation on a Medical Waste Treatment Technology S. i"" -- - - The objectives of this report are to review available waste treatment technologies and to make recommendations. Only technologies that have been documented as meeting intemationally accepted levels of microbiological inactivation efficacy are considered in this report. This report is focused on St. Kitts alone. Although the consultant has conducted many tests and technical evaluations of hospital incinerators around the world, no assessment could be made for Nevis since no information has been obtained regarding the new incinerator despite follow-up requests for data. Treatment technologies can be classified based on the fundamental processes used to decontaminate the waste. The four basic processes are: 1. Thermal processes 2. Chemical processes 3. Irradiative processes 4. Biological processes The majority of technologies employ the first two processes listed above. Thermal processes are those that rely on heat (thermal energy) to destroy pathogens in the waste. This category is further subdivided into low-heat, medium-heat, and high-heat thermal processes. This further subclassification is necessary because physical and chemical mechanisms that take place in thermal processes change markedly at medium and high temperatures. Low-heat thermal processes are those that use thermal energy to decontaminate the waste at temperatures insufficient to cause chemical breakdown or to support combustion or pyrolysis. In general, low-heat thermal technologies operate between 200°F to about 350°F (930C -177°C). The two basic categories of low- heat thermal processes are wet heat (steam) and dry heat (hot air) disinfection. Wet heat treatment involves the use of steam to disinfect waste and is commonly done in an autoclave. Microwave treatment is essentially a steam disinfection process since water is added to the waste and disinfection occurs through the action of moist heat and steam generated by microwave energy. In dry heat processes, no water or steam is added. Instead, the waste is heated by 1 Reicii and Rcoinniendaltion oni ai Wehial Pf/Paste Tl lat7wnt TfL hITl0h/o?JQ conduction, natural or forced convection, and/or thermal radiation using infrared heaters. Medium-heat thermal processes take place at temperatures between 350 to 700°F (177°C-3700C) and involve the chemical breakdown of organic material. These processes are the basis for relatively new technologies. They include reverse polymerization using high-intensity microwave energy and thermal depolymerization using heat and high pressure. High-heat thermal processes generally operate at temperatures ranging from around 1,0000F to 15,000°F (540°C-8,300°C) or higher. A significant change in the mass and volume of the waste also occurs. Examples include incineration, plasma pyrolysis, and induction-heated furnaces. Chemical processes employ disinfectants such as dissolved chlorine dioxide, bleach (sodium hypochlorite), peracetic acid, or dry inorganic chemicals. To enhance exposure of the waste to the chemical agent, chemical processes often involve shredding, grinding, or mixing. In liquid systems, the waste may go through a dewatering section to remove and recycle the disinfectant. Besides chemical disinfectants, there are also encapsulating compounds that can solidify sharps, blood, or other body fluids within a solid matrix prior to disposal. One developing technology uses ozone to treat medical waste and others utilize catalytic oxidation. Another system uses alkali to hydrolyze tissues in heated stainless steel tanks. Solidification or inertization could be considered types of chemical processes for treating biomedical waste. Irradiation-based technologies involve electron beams, Cobalt-60, or UV irradiation. These technologies require shielding to prevent occupational exposures. Electron beam irradiation uses a shower of high-energy electrons to destroy microorganisms in the waste by causing chemical dissociation and rupture of cell walls. The pathogen destruction efficacy depends on the dose absorbed by the mass of waste, which in tum is related to waste density and electron energy. Germicidal ultraviolet radiation (UV-C) has been used as a supplement to other treatment technologies. Irradiation does not alter the waste physically and would require a grinder or shredder to render the waste unrecognizable. Biological processes employ enzymes to destroy organic matter. Only a few technologies have been based on biological processes. Mechanical processes--such as shredding, grinding, hammermill processing, mixing, agitation, liquid-solid separation, conveying (using augers, rams, or conveyor belts), and compaction - supplement treatment processes. Mechanical destruction can render the waste unrecognizable and is used to destroy needles and syringes so as to minimize injuries or to render them unusable. In the case of thermal- or chemical-based processes, mechanical devices such as shredders and mixers can also improve the rate of heat transfer or expose more surfaces to chemical disinfectants. Mechanical processes can add significantly to the level of maintenance required. A mechanical process is supplementary and cannot be considered a treatment process per se. 2 Re1vici atl Raoinnnchitown /n a Aluizl oI"kthd TreCnnnt TecIuhulo(ov The approach for selecting and recommending technologies is based on: a) The appropriateness of the technology for St. Kitts in terms of size (throughput rate) b) Level of commercialization c) Cost of the technology d) Ability of the technology to meet current international environmental standards e) Others factors including space, utility and other installation requirements; feed opening size; reduction of volume and/or mass; occupational safety; noise and odor; level of automation and ease of use; skills and training required to operate; reliability and maintenance requirements; availability of technical support; and vendor background. The location of the new technology will be discussed with stakeholders and recommendations will be made at a later time. SIZE To determine the appropriate size of a treatment technology, it is necessary to estimate the amount of medical waste generated at St. Kitts. One can calculate the following generation rates for St. Kitts alone (assuming the island's population is 3/4ths of the total population): 12,214 kg/yr of infectious in 2002. Projecting to the year 2015 gives 12,901 kg/yr of infectious waste. These figures were obtained based on CBCL data and the factor of 0.4 kg per capita. A second estimate is provided below. For purposes of comparison, a higher estimate can be obtained using the upper range of estimates provided by the World Health Organization (WHO) for a district hospital (1.8 kg total waste per bed per day; infectious waste including sharps = 16% of total waste) and for an urban health center (0.01 kg per day per patient). For JNF Hospital, the total beds after the new construction, 150 beds, will be used. For Pogson and Mary Charles Hospitals, 36 and 10 beds respectively will be used. For the 11 health centers, the following assumptions will be used based on information provided by Newtown Health Center: 60 patients per day for Basseterre, 30 for Newtown, and 20 for all the other health centers. Furthermore, calculations will be based on 7 days per week operation for the hospitals and 5 days per week operation for the health centers. Using these parameters, one then computes an upper range of 21,223 kg per year for St. Kitts (about twice the estimates computed above). Therefore, estimates of waste generation range from 12,214 to 21,223 kg of infectious waste per year at St. Kitts. Treatment technologies are generally rated on a per hour or per day basis. Assuming the treatment technology will be used 5 days a week (261 weekdays per year), the following daily throughput rates are 3 R,oic'i1 and Recommendation ot tI A1fetihal "astL' 7r'abnnenlt Tech'iluokV required: 47 to 81 kg per day (104-180 lbs/day). Assuming 2 hours of operation per day, the following hourly throughput rates are required: 24 to 41 kg per hour (53-90 lbs/hr). Hence, the treatment technology should be sized as close as possible to this throughput rate. In terms of volume, the daily rates range from 430 - 740 liters per day (15 - 26 cu. ft per day). LEVEL OF COMMERCIALIZATION Some technologies, such autoclaves, have been in operation for decades, while others, such as plasma pyrolysis, are still in the development or demonstration stage. For this report, technologies that are well established with a documented track record will be selected. COST A treatment technology costing around $100,000 will be used in the selection critera. ENVIRONMENTAL STANDARDS For the purpose of selection, the U.S. Environmental Protection Agency's emission limits in the 'Hospital / Medical / Infectious Waste Incinerator Rule" and the limits in the toxicity characteristic leachate procedure (TCLP) test will be used as criteria for air emissions and solid residues respectively. These criteria are relevant to thermal treatment technologies. U.S. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) will be used as criteria for ambient air concentrations in the workplace. Another criteria to be used will be whether the technology is an approved treatment technology in one or more of the states of the United States. Thermal treatment technologies should be able to show that their emissions meet the EPA limits under the 1997 'Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Hospital / Medical / Infectious Waste Incinerators." Table 1 below shows the emission limits set on nine criteria pollutants under the rule for new incinerators. In addition, new incinerators are restricted to a 5% visible emission limit for fugitive emissions generated during ash handling and a 10% stack opacity limit. If test results of the solid residue exceed the limits under EPA's toxicity characteristic leachate procedure (TCLP), the ash must be treated as hazardous waste. TCLP is a testing procedure wherein an extract from a 100 gram sample of the ash is tested for 40 toxic substances; if the analysis shows that one of the substances is present at a concentration higher than that specified in the TCLP, the ash is considered hazardous waste. This will be used as general criteria since TCLP results can depend on the composition of waste treated. 4 RLI'W1I azi Rcconintewnd/tui oi a.10/ aA1(11 ,a! ltre T,r-annent Ttchnol(%A Table 1. Emission Limits for Biomedical Waste Incinerators Pollutant Emission Limits Small Medium Large Particulate Matter 69 mg/dscm 34 mg/dscm 34 mg/dscm Carbon Monoxide 40 ppmv 40 ppmv 40 ppmv Dioxins/Furans 125 ng/dscm total 25 ng/dscm total 25 ng/dscm total or 2.3 ng/dscm TEQ or 0.6 ng/dscm TEQ or 0.6 ng/dscm TEQ Hydrogen Chloride 15 ppmv 15 ppmv 15 ppmv or 99% reduction or 99% reduction or 99% reduction Sulfur Dioxide 55 ppmv 55 ppmv 55 ppmv Nitrogen Oxides 250 ppmv 250 ppmv 250 ppmv Lead 1.2 mg/dscm 0 07 mg/dscm 0.07 mg/dscm or 70% reduction or 98% reduction or 98% reduction Cadmium 0.16 mg/dscm 0.04 mg/dscm 0 04 mg/dscm or 65% reduction or 90% reduction or 90% reduction Mercury 0 55 mg/dscm 0.55 mg/dscm 0.55 mg/dscm or 85% reduction or 85% reduction or 85% reduction Capacities: small=less than or equal to 200 lbs/hr, medium=greater than 200 lbs/hi to 500 lbs/hr; large=greater than 500 lbs/hr. Wastewater discharges should be at a minimum while posing no problems to sanitary sewers or water treatment facilities. OTHER FACTORS Space is usually a premium at health care institutions. The space needed to operate a technology should fit the available space in the facility. That space is not only the footprint and height of the equipment but should also consider additional space needed for opening waste entry doors, access to control panels, space for moving bins, storage areas, etc. Some technologies only need an electrical outlet to operate, others require steam, compressed air, natural gas, drains, ventilation, etc. Not all these utility services and other infrastructure may available at the selected site. Concrete pads, access paths, curb cuts, and other site preparations may be needed. The location may or may not be on ground level. In addition to proper throughput capacity, the technology should also have a waste feed entry area that is large enough to be able to introduce infectious waste bags or containers into the treatment chamber without any problems. Some technologies have large treatment chamber but are limited by small entry doors. Volume and/or mass reduction is another important factor especially if facilities pay by volume or mass for hauling the treated waste and disposing at a landfill. A high reduction in waste volume can help minimize environmental impact. Issues of occupational safety and health are important. Consideration should be given to potential worker exposure to: hot surfaces, ionizing and non-ionizing radiation, chemicals released in the workspace, sharps that may fall out during conveying, pathogens from the waste that are aerosolized during shredding, blood splatter, etc. Ergonomic issues should also be considered. 5 Revicii a(wl Recoinniendatlon ont ai A'ludlcl PPaste 7i) ,jtfnent Te.mc/ lzoloc? In the event of an equipment breakdown, the technology should have some way of protecting workers who may need to access internal parts of the equipment. Some technologies have a way of injecting chemical disinfectants on untreated waste and intemal surfaces in these situations. Others have safety interlocks that prevent workers from opening a treatment chamber door if the treatment cycle has been interrupted. An ideal technology is one that is noiseless and odor-free during operation. The best way to evaluate this is to observe the technology during actual operation at an installation in another health care facility if possible. Reducing noise and noxious odors are important aspects of occupational health and community relations. A technology should be automated to minimize operator errors while allowing efficient and easy control of the process, safety interlocks, diagnostics, remote monitoring, alarms, and automatic documentation to meet record keeping requirements. Most technologies are also designed for ease of use and minimal operator time. Usually, the most labor-intensive task is introducing waste into the equipment. It is also a source of occupational injuries (e.g., back problems, needle-sticks). Many technologies now include automatic feed assemblies such as cart lifters or bin dumpers to eliminate handling of red bags by workers. When selecting a technology, the level of required skills and necessary training of the operator will be considered. Vendors generally offer operator training when a new system is installed; the facility may need to arrange for ongoing training and education. Operator training should include: a basic understanding of the systems, standard operating procedures, occupational safety and personal protection equipment, identifying waste that should not be treated in the technology, recognizing technical problems, dealing with unusual conditions, periodic maintenance schedules, emergency procedures, and contingency plans. Facilities should document operator training and qualification. Reliability of equipment can be determined from past maintenance records (these may or may not be available for new technologies). Some vendors offer remote monitoring and diagnostics capabilities. High maintenance items include major moving parts such as mixing paddles, shredders, grinders, and feed systems, and parts that are subjected to high thermal stresses such as refractories. It is useful to see if vendors are well stocked with spare parts and staffed with technical people who can respond quickly to queries or provide urgent repair services. The availability of technical support is important especially for newly commercialized technologies that may not have a long track record of operation. It is important how long a technology manufacturer and/or vendor has been in business, what their financial status is (i.e., are they financially stable), the backgrounds of key officers of the company, whether or not they have been cited for environmental or other violations, and any financial or legal liabilities. 6 Revi'li a .nd. Rcco,ninendarion o), a. .'edua l lIl astu TrelCtment 7Technu1ocLi In this section, 49 treatment technologies will be screened based on the first four crtera mentioned above. The table below summanzes the results. Table 2. Treatment Technologies for Medical Waste Type of Process Technology Vendors Size Cost Corn* Env* LOW-HEAT THERMAL PROCESSES _ Autoclave or Retort Bondtech (Somerset, KY) N y y y Autoclave or Retort Environmental Techtonics Corp N N y y (Southampton, PA) I Autoclave or Retort Lajtos (France) y N y y Autoclave or Retort Mark Costello (Carson, CA) N y y y Autoclave or Retort Sierra Industnes (Santa Ana, CA) N y y y Autoclave or Retort StenTech (Bloomington, IN) y y N y Autoclave or Retort Tuttnauer (Ronkonkoma, NY) y y N y Vacuum-Steam-Compaction San-l-Pak (Tracy, CA) y y y y Steam-Mixing- Tempico (Madisonville, LA) N N y y Fragmenting/Drying/ Shredding Shredding/Steam-Mixing/Drying, Stenle Technologies Inc (West N N y y Chemical Chester, PA) Shredding-Steam-Mixing/Drying Antaeus Group (Hunt Valley, y N N y MD) Shredding-Steam-Mixing/Drying Ecolotec (Union Grove, AL) y N N y Steam-Mixing-Fragmenting/Drying Hydroclave Systems Corp y y y y (Kingston, Ontano, Can ) Pre-Shredding/Steam-Mixing Aegis Bio-Systems (Edmond, N N y y OK) Shredding/Steam-Mixing- LogMed (Erdwich N N N Y Compaction ZerkleinerungsSysteme GmbH Microwave Treatment Sanitec (West Caldwell, NJ) N N y y Microwave Treatment Sintion/CMB (Austna) Y Y N Y Electro-Thermal Deactivation Stencycle (Lake Forest, IL) N _ __ Dry Heat Treatment KC MediWaste (Dallas, TX) N N y y Dry Heat Treatment Demolizer N y y y NMEDIUNI-HEAT THERMIAL PROCESSES Reverse Polymenzation Environmental Waste N N N Intemational (Ajax, Ontano) Thermal Depolymenzation Changing World Technologies N N N (West Hempstead, NY) HIGH-HEAT THERMAL PROCESSES Standard Incineration y N y ** Pyrolysis-Oxidation Oxidation Technologies N N y y (Annapolis, MD) Plasma Pyrolysis DayStar/Prometron (Tokyo, N N N9 Japan) Plasma Pyrolysis Electro-Pyrolysis, Inc (Wayne, N N N ? I _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ PA ) Plasma Pyrolysis HI Disposal Systems N N N ? 7 ReL'eii aindl RecommL'nldaftion on 1i aILA(l . al R'astt- T tl(lnnenl Tec1hiuolocD (Indianapolis, IN) Plasma Pyrolysis Integrated Environmental Systems N N N y (Richland, WA) Plasma Pyrolysis MSE Technology Applications N N N? (Butte, MT) Plasma Pyrolysis Plasma Pyrolysis Systems N N N (Stuyvesant Falls, NY) Plasma Pyrolysis Startech Environmental Corp N N N (Wilton, CT) Plasma Pyrolysis Unitel Technologies (Mt. N N N Prospect, IL) Plasma Pyrolysis Vance IDS/Bio Arc (Largo, FL) N N N 9 Plasma Pyrolysis Vanguard Research Inc (Lorton, N N N? VA) Induction-Based Pyrolysis Vanish Technologies/LFR N N N (Rantan, NJ) Laser-Based Pyrolysis Anara Group (Las Vegas, NV) N N N? Superheated Steam Reforming Duratek (Columbia, MD) y N N y Advanced Thermal Oxidation NCE Corporation (Carrollton, N N N TX) CHEMICAL PROCESSES Sodium Hypochlonte-Hammenmill Circle Medical Products N N y y (Indianapolis, IN) Sodium Hypochlonte-Shredding MedWaste Technologies Corp. N y y (mobile) (Houston, TX) Chlonne Dioxide- Encore/Medical Compliance (El N N y y Shredding/Gnnding Paso, TX) Ozonation Lynntech (College Station, TX) y N y Electrocatalytic Wet Oxidation MeDETOX/Delphi Research N N y (Albuquerque, NM) "Stencid"-Shredding-Mixing MCM Environmental y ? N y Technologies (Gilboa, Israel) Dry Inorganic Chemical-Shredding Positive Impact Waste Solutions N N y (Pearland, TX) Dry Inorganic Chemical-Shredding Premier Medical Technology N N y (Houston, TX) Peracetic Acid-Gnnding Ecocycle 1O/STERIS Corp y y N y (Mentor, OH) Alkaline Hydrolysis WR` (Indianapolis, IN) y N y y IRRADIATION PROCESSES Electron Beam BioStenle Technology (Fort N N N y Wayne, IN) Electron Beam-Shredding U Miami E-Beam (Coral Gables, N N N y FL) BIOLOGICAL PROCESSES Enzyme-Based Bio Conversion Technologies, N N N Treatment/Extrusion Inc (Norcross, GA) I Legend Com = Level of Commercialization, Env = Environmental Standards, y = meets basic cntena, N = does not meet cntena, ? = no data available, technology has not been tested, or technology is still in development stage and cost figures are not yet established' ** = see discussion in the next section A screening of available technologies using the first four criteria results in the following potential options: San=4-pak and KfydrocDave. 8 RciI(wit azndl Rc( ommlcnldemol n l oa n aAl IC(eol 11 i.'tc 'Fircrinent TL'chnnlokX S * * g kg ~~* Di-1G IA *04 In this section, autoclaving and incineration are compared. ADVANCED AUTOCLAVES An autoclave consists of a metal chamber sealed by a charging door and surrounded by a steam jacket. Steam is introduced into both the outside jacket and the inside chamber which is designed to withstand elevated pressures. Because air is an effective insulator, the removal of air from the chamber is essential to ensure penetration of heat into the waste. This is done in two general ways: gravity displacement or pre-vacuuming. In a gravity-displacement (or downward-displacement) autoclave, steam is introduced under pressure into the chamber forcing the air downward into an outlet port or drain line in the lower part of the chamber. A more effective method is the use of a vacuum pump to evacuate air before introducing steam, as is done in pre-vacuum autoclaves. Pre-vacuum (or high-vacuum) autoclaves need less time for disinfection due to their greater efficiency in taking out air. A retort is essentially an autoclave except that a retort has no steam jacket. Autoclaves and retorts require a minimum exposure time and temperature to achieve proper disinfection. Time-temperature recommendations for various conditions are found in a number of references (See for example: J.L. Lauer, D.R. Battles, and D. Vesley, "Decontaminating infectious laboratory waste by autoclaving," Appl. Envron. Microbiol. 44 (3), 690-694, September 1982, W.A. Rutala, M.M. Stiegeland, and F.A. Sarubbi, Jr., "Decontamination of laboratory microbiological waste by steam sterilization," Appl. Environ. Microbiol. 43, 1311- 1316, June 1982; E. Hanel, Jr., "Chemical Disinfection" in Control of Blohazards in the Research Laboratory, Course Manual, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, MD, 1981; Herman Koren, Environmental Health and Safety, Pergamon Press, NY, 1974). As shown in the table below, the recommended exposure times are based on twice the minimum time required to achieve a 6 logl0 kill of bacterial spores under ideal conditions; equivalent exposure times at different temperatures can be estimated. A common exposure temperature-time criterion is 121°C (250°F) for 30 minutes. Table 3. Exposure Time-Temperature Criteria for Disinfection Temperature Spore Kill Minimum Time Exposure Time Degrees F Degrees C Minutes Minutes 240 116 30 60 245 118 18 36 250 121 12 24 257 125 8 16 270 132 2 4 280 138 1 2 9 Revl I"I(, and1f Rcolnnwndatlon on ti A'ludlLal Kast.' TLrannLent TL'chInloa.j Color-changing chemical indicators or biological monitors (e.g., B. stearothernophilus or B. subtilis spore strips) placed at the center of test loads should be used to verify that sufficient steam penetration and exposure time have occurred. Steam treatment is a proven technology with a long and successful track record. The technology is easily understood and readily accepted by hospital staff and communities. Autoclaves are an approved or accepted medical waste treatment technology in all states of the United States. If proper precautions are taken to exclude hazardous materials, the emissions from autoclaves and retorts are minimal. Capital costs are relatively low compared to other technologies. In the last few decades, a second generation of steam-based systems have been developed for the purpose of improving the transfer of heat into the waste, achieving more uniform heating of the waste, rendering the waste unrecognizable, and/or making the treatment system easier to use. These new systems have sometimes been referred to as advanced autoclaves. These systems basically function as autoclaves or retorts but they combine steam treatment with pre-vacuuming and various kinds of mechanical processing before, during, and/or after steam disinfection. San-D-Pak is one of the more established technologies among the advanced autoclaves. Since 1978, they have installed some 700 units in the United States and in about a dozen countries around the world. The technology basically integrates high vacuum/autoclave with compaction and uses articulating chambers to facilitate the introduction and removal of waste. In the San-l-Pak systems, the autoclave cycle begins with a high vacuum to remove air, followed by exposure to 307°F (153°C) steam. The chamber is allowed to reach temperatures of 281-284°F (138-140C) or about 38 psig. After treatment, the steam vents down through a diffuser to condense the steam and the waste is automatically conveyed to a cart or compaction chamber. In the mid-1990s, San-l-Pak developed a new line of articulating chambers, a modular design wherein each chamber has three basic positions. In the load position, the chamber is tilted with the door facing up making it easier for the operator to insert an optional autoclavable liner and load the waste. The load tilt position also prevents waste from falling out during loading. The chamber is then rotated to a horizontal position to start the treatment cycle: air is evacuated using a vacuum and 307°F (1530C) steam is introduced (evacuated air is mixed with steam to destroy pathogens and then reintroduced into the chamber). The waste is exposed to steam for 30 minutes from the time the chamber temperature reaches 270°F (1320C) and a maximum of 284°F (140°C). After treatment, the steam vents down through a diffuser. The operator opens the door and initiates the dump cycle in which the chamber rotates down allowing the waste to drop into a waste bin or compactor. Units have digital displays and strip printers for documentation. San-l-Pak offers a wide range of integrated custom designs based on dozens of models. Multiple units can be lined up along a common load platform and waste can be loaded from ground or dock level. Moreover, San-l-Pak offers cart 10 Rewtic'l alnll Rc eonni'endation (i a Al dical l '1O(tL 7 cannen't 7Techno1lo(r dumpers, conveyors, single- and two-stage shredders, compactors with 4-to-1 and 6-to-1 compaction ratios, bailers, and auto-weighing systems. The modular design makes it easy to add units later to increase throughput capacities. The Hydroclave is basically a double-walled (acketed) cylindrical vessel with mixing/fragmenting paddles inside. The waste is loaded through the loading door on top of the vessel. After the door is closed, high temperature steam enters the outside jacket to heat up the waste via the hot inner surface. During this time, a shaft and paddles rotate inside to fragment and tumble the waste. The moisture in the waste tums to steam and pressurizes the inner vessel; however, if there is not enough moisture, a small amount of steam is added until the desired pressure is met. In the Hydroclave, the temperature is maintained at 270°F (1 320C) for 15 minutes (or 250°F [1210C] for 30 minutes) while the mixing paddles continue to rotate. After treatment, the steam is vented through a condenser while maintaining heat input, causing the waste to dry. The steam to the jacket is shut off, the discharge door is opened, and the shaft and paddles reverse rotation to scoop the waste out through the loading door onto a conveyor or waste container. A strip chart recorder documents the process parameters. INCINERATORS Incineration is a high-temperature oxidation process wherein waste is burned to produce combustion product gases, ash, and incombustible residues. A typical incinerator has a waste loading system, refractory-lined primary chamber (hearth or furnace) and a secondary chamber, ash removal system, and flue gas stack. Incinerators also have air pollution control devices and controls. In the past, single-chamber hearths with stationary grates were used to burn medical waste. However, since these incinerators could not reach high temperatures and their emissions did not meet environmental standards, these oven-type incinerators (such as the ones used in St. Kitts and Nevis) have not been in use in the United States and other developed countries for decades. In the last three decades, there have been three basic incinerator designs used for medical waste: (1) controlled air incinerators, also called starved air, two-stage, or modular incinerators; (2) multiple-chamber incinerators, also called retort, pyrolitic, or excess air incinerators; and (3) rotary kiln incinerators. Controlled air incineration, the most common design used in the last 25 years, uses a primary chamber with less than the full amount of oxygen needed for complete combustion. Moisture and volatile fractions are vaporized while carbonaceous materials are burned to ash and incombustible fractions accumulate in the residue. A secondary chamber is where volatile gases are combusted under turbulent and excess air conditions. In multiple- chamber incinerators, both primary and secondary chambers are usually operated with excess air. The two basic designs are retort and in-line units. A rotary kiln incinerator also consists of a primary and secondary chamber 11 Re1vic1ii and Rccotnenudantlon on a. ILfu'lhaol V.lxl.f Il1sltrelamln Teclhnolog but its primary chamber is a cylindrical, rotating kiln slightly inclined so waste material moves towards the discharge end as the kiln rotates. Ash accumulates in the primary chamber, falls through grates into a pit below the chamber, or is pushed by transfer rams towards an ash container, discharge chute, or water pit at the end of the hearth. During combustion, hydrocarbons in the waste are converted to carbon dioxide and water. Also emitted are NOx, SOx, flyash (ash that is carried in the flue gas), and products of incomplete combustion such as carbon monoxide and soot (found in particulate matter). Hydrogen chloride gas (HCI), polychlorinated dibenzo- p-dioxins, and polychlorinated dibenzofurans are formed due to chlorine in the waste. Trace metals are also released as metal vapors or deposited in fine particles entrained in the exhaust stream; they may play a role in catalyzing the formation of dioxins and furans on fly ash. ENVIRONMENTAL ISSUES Autoclaves: Odors can be a problem around autoclaves if there is insufficient ventilation. If waste streams are not properly segregated to prevent hazardous chemicals from being fed into the treatment chamber, toxic contaminants will be released into the air, condensate, or in the treated waste. This is the case when waste loads contaminated with chemotherapeutic waste or heavy metals such as mercury are put in the autoclave. Thus, poorly segregated waste may emit low levels of alcohols, phenols, aldehydes, and other organic compounds in the air. Decontaminated waste from an autoclave retains much of its physical appearance. Some plastics such as low density polyethylene soften at autoclave temperatures in a San-l-Pak and cause the resulting treated waste to form an amorphous mass but with recognizable waste. The Hydroclave breaks the waste inside the treatment chamber and results in a somewhat unrecognizable mass. In general, as long as organic compounds and leachable inorganic material containing arsenic, barium, cadmium chromium, lead, mercury, silver or other inorganic chemicals are kept out of the waste, the treated waste residue should pass the TCLP test. Incinerators: Environmental emissions are the most serious problem facing incinerators. It is the reason why the number of hospital incinerators in the United States has dropped dramatically in the last decade. In 1988, US EPA estimated that there were 6,200 medical waste incinerators in the United States. In 2002, only 767 medical waste incinerators will be in operation and many of those are large commercial facilities using expensive pollution control devices to meet EPA's emission standards. Only four new medical waste incinerators have been constructed in the United States since June 1996 and one of the four had to be shut down recently. A medical waste incinerator releases into the air a wide variety of pollutants including highly toxic dioxins and furans, metals (such as lead, mercury, and cadmium), particulate matter, acid gases (hydrogen chloride and sulfur dioxide), carbon monoxide, and nitrogen oxides. These emissions have serious adverse consequences on worker safety, public health and the environment. Dioxins, for 12 RL'v1ic' an .Z/XRcLoiiinncwndauotnoi7 on Ic aludica/ Ifcast.c Treatmntn 7TechnolouI example, have been linked to cancer, immune system disorders, diabetes, birth defects, and other health effects. Mercury is associated with nervous system disorders particularly affecting developing fetuses and small children. Medical waste incinerators are a leading source of dioxins and mercury in the environment. Incinerator ash remaining at the bottom of an incinerator after burndown often contains heavy metals that may leach out. Dioxins and furans may also be found in the bottom ash. As noted earlier, if test results of the ash exceed the limits under EPA's TCLP, the ash must be treated as hazardous waste. Because of high levels of leachable contaminants found in incinerator ash, some regulatory authorities have simply designated incinerator ash as hazardous waste. Fly ash (ash that is carried by the air and exhaust gases up the incinerator stack) contains heavy metals, dioxins, furans, and other toxic chemicals that condense on the surface of the ash. Even when the fly ash is removed from the exhaust stream by pollution control devices such as baghouse filters, the toxic materials remain concentrated on the filter cake and should be treated as hazardous waste. To meet the 1997 EPA emission limits, medical waste incinerators will need air pollution control devices such as high efficiency wet or dry scrubbers and baghouse filters with or without activated carbon. In older incinerators, secondary chambers may have to be retrofitted to insure at least a two-second retention time. Periodic stack tests must be performed to show compliance with the rules, and facilities must continuously monitor operating parameters such as secondary chamber temperature. The EPA regulations also require operator training and qualification, inspection, waste management plans, reporting, and record- keeping. PUBLIC HEALTH AND OCCUPATIONAL SAFETY ISSUES Autoclaves: If waste streams are not properly segregated to prevent hazardous chemicals from being fed into the treatment chamber, toxic contaminants will be released into the air, condensate, or in the treated waste. This is the case when waste loads contaminated with antineoplastic drugs or heavy metals such as mercury are put in the autoclave. Thus, poorly segregated waste may emit low levels of alcohols, phenols, aldehydes, and other organic compounds in the air. A study of one autoclave facility by the U.S.-based National Institute for Occupational Safety and Health found no volatile organic compounds (VOCs) in a worker's personal air space and work area that exceeded permissible exposure limits set by the Occupational Safety and Health Administration (K. Owen, K. Leese, L. Hodson, R. Uhorchak, D. Greenwood, D. VanOsdell, and E. Cole, "Control of Aerosol (Biological and Nonbiological) and Chemical Exposures and Safety Hazards in Medical Waste Treatment Facilities," National Institute of Occupational Safety and Health, Cincinnati, OH, November 1997). The highest VOC level in the autoclave facility was 2-propanol, measured at 643 mg/m3, which is about three orders of magnitude lower than the permissible exposure limit of 400,000 mg/m3. The data show that, compared to incinerators, autoclaves have far lower emissions of pollutants with less adverse impacts on human health. 13 Rei'ic''10 4'nd Ra' onlfenl da'i1(1lonl oil a Al'It'th(1l I4aiste 7i etnntlLt Tetuchzo,(lo Incinerators: In contract to autoclaves, many studies have been done on the emissions from incinerators showing adverse impact on human health. This section, while not intended to be an in-depth and comprehensive review, briefly summarizes a number of epidemiological studies showing serious health effects among waste incineration workers and community residents living near incinerators. Epidemiological studies have shown significant associations between exposure to incinerator emissions and lung cancer, laryngeal cancer, ischemic heart disease, urinary mutagens and promutagens, as well as elevated blood levels of various toxic organic compounds and heavy metals. A summary of epidemiological studies from 1988-1998, presented in chronological order, is given in Table 4. PATHOGEN DESTRUCTION ISSUES Autoclaves: With respect to pathogen inactivation, all states in the United States accept or approve the use of autoclaves for medical waste treatment. Several studies appear in the literature on the effectiveness of steam autoclave treatment of biomedical waste. They include the following: Rutala et al. (Rutala WA, Stiegland MM, and Sarubbi FA Jr. Decontamination of laboratory microbiological waste by steam sterilization. Appl Environmental Microbiology, 43:1311-1316. June 1982) reported on operating parameters for sterilization of microbiological waste. Standardized test loads of contaminated petri dishes and a biological indicator containing spores of Bacillus stearothermophilus were packaged and placed in a gravity displacement autoclave. The biological monitoring ampoules used were Kilit (BBL Microbiology Systems, Cockeysville, Md.) standardized so that spores survive when autoclaved for five minutes at 1210C and spores are killed when autoclaved for 15 minutes at 1210C. Waste loads of five, 10, and 15 pounds of contaminated 100 mm petri plates and biological monitoring ampoules were placed in commercially available plastic autoclave bags constructed of 1.5 mil polyethylene. Bags were tested in two modes: 1) in the open position, with the sides of the bag folded down to expose the top layer of petri plates, and 2) with the opening In the bag loosely constricted with a twist-tie and four holes punched in the top of the bag. Water (500 ml) was added to some of the closed bags that were placed either in a shallow stainless steel tray or a shallow polypropylene container. The containers were placed in the steam autoclave and treated for periods of 15, 30, 45, or 90 minutes. The load temperature was monitored by thermocouple at five- minute intervals during the test. At the conclusion of the test cycle the biological indicators were removed and incubated at 560C for seven days. Sterile swabs were dipped into the molten agar and swabbed onto blood agar plates which were incubated aerobically at 350C for 48 hours before growth evaluation. In 10 percent of the experiments, plates were also incubated anaerobically at 350C for 96 hours. 14 Rri'ut, izidI/ R (on7Inindion f on a Aluod(al f+1"Ist 71 catinL'nt Tiechnol1oe Table 4. Summary of Epidemiological Studies on Adverse Health Effects Associated with Incineration STUDY SUBJECTS CONCLUSIONS REGARDING REFERENCE ADVERSE HEALTH EFFECTS Residents from 7 to 64 Levels of mercury in hair mcreased with P. Kurttio et al., Arch Environ. years old livmg within 5 km closer proximity to the incinerator dunng a 10 Health, 48, 243-245 (1998) of an incinerator and the year penod mcinerator workers Residents lving withim 10 Sigmficant increase mi laryngeal cancer In P. Michelozzi et al., Occup km of an mcmerator, men living with closer proximity to the Environ. Med, 55, 611-615 refinery, and waste disposal incinerator and other pollution sources (1998) site 532 males working at two Significantly higher gastric cancer mortality E. Rapiti et al., Am. J Ind mcinerators from 1962- Medicine, 31, 659-661 (1997) 1992 Residents living around an Significant increase in lung cancer related A. Biggen et al. Environ Health uincmerator and other specifically to the incinerator Perspect, 104, 750-754 (1996) pollution sources People livmg withim 7.5 km Risks of all cancers and specifically of P Elliott et al., Br J Cancer, of 72 mcinerators stomach, colorectal, liver, and lung cancer 73, 702-710 (1996) increased with closer proximruty to incmerators 10 workers at an old Significantly higher blood levels of dioxms A. Schecter et al , Occup incmerator, 11 workers at a and furans among workers at the old Environ Medicine, 52, 385-387 new incinerator mcinerator (1995) 122 workers at an mdustnal Higher levels of toluene, lead and cadmium in R. Wrbitzky et al., Int Arcli incmerator the blood, and hlgher levels of Occup Environ Health, 68, 13- tetrachlorophenols and arsenic in urne 21 (1995) among incmerator workers 53 incnerator workers Significantly higher blood and urine levels of J Angerer et al., Int Arch hexachlorobenzene, 2,4/2,5-dichlorophenols, Occup Environ Health, 64, 2,4,5-trichlorophenols, and hydroxypyrene 266-273 (1992) 37 xvorkers at four Significantly higher prevalence of urnary X F. Ma et al., J Toxicol incinerator facilities mutagen/promutagen levels Environ Health, 37, 483-494 (1992) 56 workers at three Significantly higher levels of lead and R. Malkin et al., Environz Res, incmerators erythrocyte protoporphyrn In the blood 59, 265-270 (1992) 86 incinerator workers High prevalence of hypertension and related E.A Bresnitz et al, Am J Iid protemuna Medicine, 22, 363-378 (1992) 104 workers at seven Sigmficantly higher prevalence of unnary J.M. Scarlett et al., J Toxicol incinerator facilities mutagen and promutagen levels Environ Health, 31, 11-27 (1990) 176 incmerator workers Excessive deaths from lung cancer and P. Gustavsson, Amn J Iid employed for more than a ischemic heart disease among workers Medicine, 15, 129-137 (1989) year from 1920-1985 employed for at least I year, significant mcrease in deaths from ischemic heart disease among workers employed for more than 30 years or followed up for more than 40 years Residents exposed to an Reproductive effect. frequency of twinnmig O.L. Lloyd et al., Br J Ind incinerator increased in areas at most nsk from Medicine, 45, 556-560 (1988) incinerator emussions 15 Revc"'ic t'h a R o omlmenda1tion oil a AiCeh1 at aAl.: tl ' r,`(aturatineld iech lo)l(j The study showed that the most Important factor with regard to treatment effectiveness were the types of containers holding the waste. The stainless steel container enhanced heat transfer and the open bag allowed better steam penetration than the constricted bag. The addition of 500-ml water to the closed bag did not improve the heat up time in either container significantly. As expected, the smallest loads (five pounds) heated up faster than the larger loads. No significant difference was found in results between the 10 and 15 pound loads. The data for the 10 and 15 pound loads indicated that 90 minutes in the stainless steel container were required to inactivate the biological indicator spores. The biological indicators were viable at all test conditions in the polypropylene container. All spore-forming and vegetative bacteria in the test loads (with or without water) demonstrated no growth after 45 minutes in stainless steel containers and after 60 minutes in polypropylene containers (without water). The test results demonstrated that for 10 to 15 pounds of waste placed in the autoclave the only conditions which insured complete kill of B. stearothermophilus and thus sterility of the load, were the use of a stainless steel container for treatment duration of 90 minutes. Lauer et al. (Lauer JL, Battles DR and Vesley D. Decontaminating infectious laboratory waste by autoclaving. Appl Environmental Microbiology, 44(3):690- 694. September 1982) evaluated the addition of water to improve the treatment of biomedical waste loads in a gravity displacement steam autoclave. Test waste loads of 1,750 or 3,500 grams of petri dishes containing agar were placed in a polypropylene autoclavable waste bag with or without the addition of water. The specific amounts of water added to the waste loads were either 100 or 1,000 ml. Biological indicators (Minnesota Mining and Manufacturing, Inc. Attest No. 1242, B. stearotherrmophilus in a steam penetrable package simulating a linen pack) and chemical Indicators (Biomedical Sciences, Inc., Thermalog S) were also added to the waste loads. The autoclave bag containing the waste load was in turn placed in either a stainless steel or polypropylene container. The waste loads were processed for 50 minutes in the autoclave at 1210C. This evaluation demonstrated that a processing time of 50 minutes was adequate for killing all biological indicator spores and converting the chemical indicator strip in the autoclave bag containing 1,000 ml of water that was placed in the stainless steel container. All other test conditions were inadequate to kill all spores. Glick et al. (1961) evaluated steam autoclaving for the decontamination of nesting type animal cages, animal carcasses, and laboratory equipment. A series of experiments were conducted on six stacked cages standing vertically or lying on their sides. Biological indicator organisms dried on filter paper discs (Bacillus subtilis var.- niger, 1 x 164 spores/disc) were placed in the litter of the used cages. Thermocouples were also placed in the litter to record the temperature in the waste load during the treatment cycle. The results of the first experiment showed that when the cages were stacked vertically and autoclaved at 15 psi, 2500F, indicator organisms remained viable after four hours. When the cages were placed in a horizontal orientation and autoclaved at 20 psi, 2600F, a treatment cycle of 30 minutes was sufficient to kill all indicator organisms. 16 Rown san RC ( nn7 01danoi7 o)l a 'h11( (1 I"n/h' 1I a 'tItmeLn/1t Techml oi,, The second experiment tested the ability of autoclave treatment to treat animal carcasses. Twenty guinea pig carcasses were placed in a five-gallon fiberboard container. A "Diack" sterilizer temperature indicator was inserted in the abdomen of the animal in the center of the load. The load was treated in the autoclave at 250°F for time periods from one to 16 hours. It took over eight hours for the center of the load to reach the desired temperature and the controls melted before 16 hours of treatment was completed. These results indicate that the autoclave is not appropriate for the decontamination of animal carcasses. The third experiment tested the steam autoclave for the treatment of metal equipment or equipment parts. The equipment parts were contaminated with a liquid spore suspension (B. subtilis var. niger, 1 x 109 spores/ml) and then autoclaved both reassembled and disassembled. A treatment cycle of four hours at 250°F was required to kill the indicator organisms on the reassembled equipment. One hour of treatment was sufficient to kill the indicator spores on the disassembled equipment parts. Cole et al. (E.C. Cole and K. Leese, "Evaluation of Medical Waste Treatment Technologies: Final Report," prepared for the Office of Solid Waste, U.S. EPA, RTI Report number 5400-005/01 F, Research Triangle Institute, Research Triangle Park, NC, January 1993) evaluated laboratory as well as larger autoclaves to determine their efficacy. The results of laboratory and field tests showed steam autoclaving to be effective in treating biomedical waste. Laboratory data showed that high level challenges (with blood serum) of various organisms in surrogate waste loads were readily inactivated by relatively low temperature (1040C), short-term (5 min) exposure to the steam autoclaving process regardless of direct steam contact. Additionally, both laboratory and field data showed that high concentrations of bacterial spores were readily inactivated at a setting of 1210C by exposure to the combined effects of steam, heat, and pressure. The San-l-Pak system was one of the technologies evaluated by the U.S. EPA in 1993 as background material for a report to Congress on medical waste management. In that study (E.C. Cole and K. Leese, loc. cit.), all levels of B. stearothermophilus (up to 106) and B. subtilis (up to 108), both steam and non- steam exposed spore containers, were inactivated in every treatment cycle tested. Incinerators: Because of the relatively high temperatures achieved in an incinerator chamber, it has long been assumed that incinerators destroy all pathogens. Limited studies have confirmed that pathogens are not released in the stack under good operating conditions. However, research has also shown that pathogens could be released in the stack and/or ash residue if incinerators are not operated under good combustion conditions. The destruction of test spores takes place when the waste is exposed to a minimum of 1,400 OF in the primary chamber and 1,600 OF in the secondary chamber with a 1.2-second residence time (M. Barbeito and M. Shapiro, "Microbiological Safety Evaluation of a Solid and Liquid Pathological Incinerator," Journal of Medical Primatology, 6:264-273, 1977). 17 Rewii aiul Rao onWldllCfl(1ti017 oln a AI A al PI ,I ate Tr .cainei 7i ( Techinloc Below these conditions, test spores have been found to survive. Thus, some states have required a minimum temperature of 1,800 OF in the secondary chamber and a minimum 2-second residence time as a safety factor to assume total destruction of all pathogens. During poor operating conditions, pathogens have been shown to survive the municipal waste incineration process in the ash residue (S. Klafka and M. Tierney, "Pathogen Survival at Hospital/infectious Waste Incinerators," Proceedings: National Workshops on Hospital Waste Incineration and Hospital Sterilization, EPA Office of Air Quality Planning and Standards, EPA- 450/4-89-002, January 1989). Another US EPA report warned that if proper operating conditions are not met, incinerators could release pathogens through discharge air and residues (Hospital Medical Waste Incinerator Operation and Maintenance, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, March 1989). COST ISSUES Of all the non-incineration treatment technologies, autoclaves and advanced autoclaves have the lowest capital cost and among the lowest operating costs. The San-l-Pak 230-3P advanced autoclave, which has a capacity from 87 to 106 lbs/hr, costs about $70,000. In a review of data from medical waste incinerator vendors, the average capital cost of small, batch-fed incinerators with no automatic feeding, no automatic ash removal, and no combustion control systems was found to be in the range of $150,000 (W.R. Seeker, "Medical Waste Incineration," in Environmental Management in Healthcare Facilities, edited by K.D. Wagner et al., W.B. Saunders Company, Philadelphia, 1998). Installation costs were typically from 15 to 25% of base equipment cost for factory-assembled and skid-mounted incinerators, higher for incinerators with more complex installation requirements. In 1995 and 1996, the US EPA conducted studies on what it would cost to add air pollution control devices to medical waste incinerators to be able to meet the EPA's emission limits. (These studies are presented in various reports in Air Docket No. A-91-61, Air and Radiation Docket and Information Center, US EPA, Washington, DC.) Using the EPA's equations, one obtains the following estimated costs (in 1995 dollars, unadjusted for inflation) for a pollution control device (wet scrubber capable of achieving 69 mg/dscm) for a small 50-lb/hr biomedical waste incinerator without a heat recovery boiler: Capital cost for wet scrubber = $194, 500 Annual costs for wet scrubber = $48,700 per year Using the EPA's equations, one also obtains the following estimated costs (in 1995 dollars, unadjusted for inflation) for monitoring equipment, stack testing, and operator training based on estimated costs to upgrade existing incinerators: 18 R,] ,-w,i z1 RI I nn iundttil lOstc (IAu u s/I UitL' Ti c'tinlaTI c 7 hnolo,,u gi Capital cost for additional equipment for parametric monitoring, periodic stack testing, and operating training = $16,600 Annual operating cost for the air pollution control device, parametric monitoring, stack testing, and training = $60,446 per year The table below tabulates these and other costs for comparing incineration and autoclaving. The cost of a small incinerator with a pollution control device and equipment for monitoring and testing costs almost four times that of an advanced autoclave. This explains why incineration was eliminated from the screening matrix above. Table 5. Capital Cost Comparisons Cost Item Incinerator* Autoclave* Base equipment cost 150,000 70,000 Installation cost 22,500 6,500 Cost of pollution control technology 194,500 0 to meet EPA emission limits for a 50 lb/hr incinerator Cost of electric steam generator 0 16,000 Cost for monitoring and testing 16,600 Monitoring - 2,000 Testing - 400 TOTAL $383,600 $93,100 * Incinerator costs based on medical waste incinerabon review by Seeker (q v.) and EPA studies (q v.) Autoclave costs based on informaton from San-l-Pak. 19 Rei1 c nd Rc(o m)mlenida>ion (fli a *Vh:llica,l 11'aiste Treatmennt Techntlohir The table below summarizes the comparison between incineration and advanced autoclaving. Table 6. Overall Comparisons Parameter State-of-the-art Incinerator Advanced Autoclave Capacity Appropnate size Appropriate size Level of Fully commercialized Fully commercialized Commercializabon Range of Wastes All types of waste treated except No chemotherapeubc, phammaceubcal, Treated radioactve waste (chemotherapy, radioactive, or chemical waste; higher pharmaceutical and chemical waste temperatures or longer times may be require a special incinerator) needed for pathological waste or animal carcasses Level of Pathogen Stenlizabon if operated properly High level disinfecton if operated Destructon properly Environmental Significant air emissions; requires Minimal air emissions; does not require Emissions costly pollubon control device pollution control device Treated Waste Unrecognizable ash; may contain Recognizable biomedical waste; sharp Residue leachable metals and organics needles may need to be destroyed including dioxin Reduction of Volume About 90-95% reducton in volume and No mass reduction -may increase weight or Mass mass due to steam condensabon; minimal volume reducton - needs shredder or compactor to reduce volume Occupational Safety Significant concems over occupabonal Possible low levels of volatile organic and Health Impacts and public health impacts; potential compounds; minimal health impacts, exposure to fire and hot surfaces potenbal exposure to steam and hot surfaces Space Requirements Larger footprint with pollution control More compact: device; stack height 33 sq ft footprint 8 5 ft height requirement Main Utilities Natural gas or diesel for bumers, Steam (may be produced using electnc Water for scrubber or natural gas boiler) Installation Concrete pad, anchoring, electncal, Concrete pad, anchoring, electrical, Requirements natural gas or diesel, water supply, steam or water supply, drain drain Feed Opening Size Adequate Adequate Noise Low Low Odor Minimal Significant odors if in an enclosed space with little ventilabon Automation, Ease of Highly automated, easy to use Highly automated, easy to use Use Skills Required Requires training in principles of Requires training in principles of steam combuston, controls, operabng sterilization, types of waste treated, procedures, waste handling, periodic controls, operating procedures, waste maintenance, contingencies, common handling, periodic maintenance, problems contngencies, validation testing 20 ReLicit and Rc oifl(lOldanon1n ai He(1hca/l Pl'sat: TI; atnlent T.chIi,olog Major Maintenance Replacement of refractores is major Replacement of large gasket is major maintenance item; significant cost maintenance item; minimal cost Reliability Fairly reliable Fairiy reliable Availability of Good availability Good availability Technical Support Cost Higher capital and operabng costs Lower capital and operabng costs In December 2000, international negotiations were completed on a global, legally binding convention to reduce and eliminate the release of persistent organic pollutants (POPs) to the environment. The final version of the text of the "Stockholm Convention on Persistent Organic Pollutants" was adopted by the Conference of Plenipotentiaries meeting in Stockholm last May 2001. It is now in the process of being ratified by different countries. Annex C of the Stockholm Convention deals with the unintended production of POPs. First in the list of three groups of POP chemicals are dioxins and furans. Once the Stockholm Convention becomes intemational law - something that is expected in the next several years - countries will be required to develop and implement an action plan within two years to address the release of dioxins and furans, promote measures to reduce their levels of release, promote the use of substitutes to prevent formation and release, and promote best available techniques and environmental practices. The Convention specifically targets medical waste incinerators among processes that have "the potential for comparatively high formation and release of these chemicals to the environment." Under the reduction measures proposed in the Convention, medical incinerator operators might be required to use improved methods for flue-gas cleaning, treat residuals to detoxify them, change processes, or modify designs to improve combustion and prevent formation of POPs. A high priority will be given to the use of alternative processes. While it is yet unclear what specific effect the Stockholm Convention will have on medical waste incineration, Article 5 of the Convention makes it clear that some measures will have to be taken to further reduce releases of dioxins and furans from medical waste incinerators with the goal of their "ultimate elimination." Incinerators have the following advantages over advanced autoclaves: ability to treat a wider range of wastes; significant volume and mass reduction; unrecognizability of treated waste residues; and minimal odors. Advanced autoclaves have the following advantages over incinerators: minimal air pollutant emissions and less impact on public health and environment; compact space requirements; lower maintenance costs; and lower capital and 21 RLn'iC1 and Rccommnnn(hation on a .1MethiLa/ fKaste' Trceatmnent Tehnoalor/gi operating costs. Also, since dioxins and furans are not produced in a steam sterilizer, autoclaves are not affected by the Stockholm Convention. The consultant recommends an advanced autoclave as the treatment technology for use in St. Kitts. In particular, the San-l-Pak 230-3P Auto-Clave is recommended for the amount of waste generated. S o;* -- A0 - "iA The following costs are based on a price quotation from San-l-Pak, Inc. (Tracy, Califomia, USA) and McKesson Medical and Surgical Supply (Sacramento, Califomia, USA) for the 3M Attest kit. Table 7. Cost Estimates for an Advanced Autoclave Quantity Item Cost BASIC EQUIPMENT: 1 Sani-l-Pak 230-3P Auto-Clave 69,503.00 1 Electnc steam generator (480 VAC) with 15,701.00 water treatment 1 Spare parts package Included in base cost 1 Messaging system Included in base cost 1 3M Attest validation test starter kit 340.25 OPTIONAL ITEMS: 1 Mobile automatic cart dumper 8,984.00 2 90-gallon fully enclosed transport cart 712.00 2 3/4 cu. yd. dump cart for treated waste 1,400 1 Deodorant system package 479.00 1 San-l-Pak weighing system 4,489.00 1 In-house monitoring software package 1,996.00 1 ICS-4 gas-fired steam boiler with water 26,906.00 treatment 22 APPENDIX B1: Tender Specificatons for an Advanced Autoclave Treatment Technology PART 1 - QUALIFICATIONS 1.1 Description: The work includes fumishing and installing (optional), for interior or exterior service, complete and ready for operation one Auto-Clave 230-3P Sterilizer. The sterilizer shall be a unit designed to handle infectious hospital waste. 1.2 Qualifications: A. Manufacturer regularly and presently manufactures sterilizers as one of its principal products. B. Installer has technical qualifications, experience, trained personnel and facilities to install specified products. C. Manufacturer's product submitted has been in satisfactory and efficient operation at similar facilities. D. There is a permanent service organization, maintained or trained by manufacturer which will render service no later than 24 hours after receipt of notification that service is needed, and be capable of providing weekend monitoring and assistance. Submit name and address of service organization. 1.3 Manufactured Products: A. Materials, fixtures, and equipment fumished shall be of current production by manufacturer regularly engaged in the manufacture of such items. 1.4 Submittals: A Before delivery, manufacturer will supply the following 1) Certificates: a. Manufacturer verifies it presently manufactures proposed equipment as a principal product. b. Installer has technically qualified personnel and facilities to install equipment specified. c. Name and address of service organization. 2) Manufacturer's literature and data: a. Brochures showing name and address of manufacturer and the catalog or model number of each item incorporated into the work. 81 -1 b. Manufacturers illustration and detailed description. c. List of deviations from contract specifications. 3) Test Report: a. A.S.M.E. certified test report on the sterilizer model to be fumished. 4) Installation Drawings: a. Show dimensions, method of assembly, installation and conditions relating to adjoining work which requires cutting or close fitting, reinforcement, anchorage and other work required for complete installation. 1.5 Safety Devices: A. Exposed couplings, motor shafts, gears or other moving parts, shall be fully enclosed and guarded, in accordance with ANSI pamphlet B 15-1, irrespective of height above the floor. 1.6 Electrical Equipment: A. Electrical equipment shall be suitable for use with electrical system indicated on drawings Provide electrical components including motors, disconnect switches, motor controllers, motor control devices and electrical circuits which conform to requirements of NFPA 70. 1.7 Name Plate: A. Each piece of equipment shall bear a corrosion-resisting steel or anodized aluminum name plate located in a reasonably accessible position, permanently secured. Name plate shall bear the name of the manufacturer, model number and serial number. 1.8 Applicable Publications: A The publications listed below form a part of this specification to the extent referenced The publications are referenced in the text by the basic designation only. 1) Federal Specifications (Fed. Spec ). a. QQ-S-736D - Steel Bars, Wire, Shapes and Forgings, Corrosion Resistant b. QQ-S-698(3) -- Steel, Sheet and Strip, Low Carbon c QQ-S-766C(5) - Steel Plates, Sheets and Strip, Corrosion Resisting 2) American Society of Mechanical Engineers (ASME): a. Boiler and Pressure Vessel Code, Section VIII - Pressure Vessels, Division I. 3) American National Standards Institute, Inc. (ANSI): a. B1 5-1 - Safety Code for Power Transmission b. Z245.1-1975 - Safety Standards B1 -2 PART 2 - PRODUCTS 2.1 Auto-Clave 230-3P Sterilizer: Auto-Clave 230-3P Sterilizer manufactured by San-l-Pak Pacific, Inc. or equal. (San-l-Pak Pacific, Inc. - 23535 South Bird Road - Tracy, CA 95376) A. Sterilizer. 1) The sterilizer design shall utilize high vacuum combined with saturated steam. The chamber shall be 17.5 cubic feet with a minimum opening of 32" (diameter). 2) The sterilizer chamber must be able to rotate into 3 positions; load, sterilize and discharge positions. 3) Sterilizer chamber doors shall automatically lock once the sterilizer cycle begins. 4) Sterilization time to be initiated only after the preset operating temperature of 2700 F is reached (customer and regulatory dependent; may be adjusted if requested) 5) The sterilizer shall be equipped with an automatic strip printer showing the date, time, operator, vacuum, pressure and temperature for each sterilization cycle. The sterilizer shall also be equipped with a digital display which displays a machine function as it takes place This display shall also alert the operator if there is a system interruption and provide instructions to correct the situation. 6) The sterilizer chamber will be constructed of stainless steel to ensure longer life of the system. 7) The sterilizer operation security shall be maintained by use of key locks and/or security codes (operator identification) on the following functions: a. Automatic sterilization cycle and discharge sequence b. All pressure doors. 8) The sterilizer must have preprogrammed sterilization parameters to avoid human error resulting in improper treatment. The sterilization parameters must be tamper proof and are not to be left to the discretion of the operator. 9) The sterilizer shall be designed so the sterilized waste can be transferred to the cart without additional operator handling. The sterilizer discharge control to be initiated by manual key switch or operator security code which may only be activated when "total kill" sterilization parameters have been achieved. B Utility Requirements. 1) The electrical service of 120 volts, single phase shall be provided for the control panel from a 30 amp circuit breaker (If the cold weather package is used, the service must be a minimum of 40 amps). Foreign voltages are acceptable 2) The saturated steam flow rate shall not exceed 125 lbs. per hour at a minimum inlet pressure of 65 psig. a. Total steam usage shall not exceed .65 lbs. steam per pound of infectious waste (including reasonable system losses). B1 -3 3) The domestic cold water service of approximately 3 gallons per minute (GPM) minimum shall be provided to the condensate tank and wash down hose. C. Controls: 1) The sterilizer's automatic operations shall be controlled by a programmable controller located within the unit. The microprocessor shall be a solid state device that is fully programmable. D. Materials: 1) Corrosion Resisting (Stainless) Steels: a. Plate, sheet and strip: Unless otherwise specified, corrosion-resisting steel flat products shall conform to chemical composition requirements of any series steel specified in Fed. Spec. QQ-S-766. b. Bars, shapes and forgings: Corrosion-resisting steel bars, shapes and forgings shall be in accordance with Fed. Spec. QQ-S-763 and shall be of 300 series in annealed condition. c. Corrosion-resisting steel tubes: Unless otherwise specified, corrosion-resisting steel tubes shall be seamless or welded at manufacturer's option. Tubing shall be in accordance with ASTMA 269. d. Finish: Exposed surfaces shall have a standard polish equal to finish No. 4. e. Corrosion-resisting (stainless) steel shall be hereinafter referred to as CRS. 2) Carbon steel: a. Sheet Steel: Fed. Spec. QQ-S-698 cold rolled, commercial quality sheet steel with No. 1 finish or better. 3) Fasteners a. Rivets, bolts, nuts, stubs, spacers and metal used for welding shall be the same kind of metal as the material joined. Where corrosion-resisting metals are joined to each other or to other metals, rivets, bolts and materials used for welding shall be corrosion-resisting metal. 4) Materials not definitely specified shall be of the quality normally used by the manufacturer in it's standard commercial sterilizers and be free of defects and imperfections which may effect serviceability or appearance of finished product. 2.2 Fabrication: A. Welding: Joints in fabricated equipment shall be welded by an accepted method. Carbon arc welding is not acceptable, nor is any process permitting the pick-up of carbon acceptable. Welds shall be strong and ductile with exposed surfaces free of imperfections such as pits, runs, spatter and cracks, and shall have the same color as adjoining surfaces. Welded joints shall be homogeneous with the sheet metal itself. Welding rods shall be of the same composition as the parts to be welded. Where sheet size necessitates a joint, such joint shall be welded. B1 -4 PART 3 - EXECUTION 3.1 Installation (Optional): A. Equipment and materials shall be suitable for indoor or outdoor installation in the available space, arranged for safe and convenient operation and maintenance. If the installation will be indoors, the optional deodorant system package is recommended; it is also suggested the unit be located in a non-odor sensitive area. B. Furnish supervision of equipment installation at construction site by a qualified factory trained technician(s) regularly employed by the equipment supplier. 3.2 Inspection: A. Before shipment from manufacturer's plant and following installation at project site, finished articles shall be thoroughly inspected and tested for compliance with specifications. 3.3 Tests: A Perform tests under operational conditions in the presence of Resident Engineer, or his/her representative. B Evidence of malfunction in any tested system, piece of equipment or component part thereof that occurs during or as a result of test, shall be corrected, repaired or replaced and the test repeated. 3.4 Instruction of Personnel: A. Provide services of a qualified technical person, at such time after installation is complete, for a period not less than 8 hours to instruct designated personnel in. 1 ) Operation and care of equipment. 2) Preventative maintenance procedures for individual items of equipment. 3) Techniques and procedures recommended by the manufacturer to achieve maximum dependable, efficient and economical utilization of the equipment. 3.5 Operating Instructions: A. Provide printed instruction books and parts lists; to be delivered to the Resident Engineer or designee. These manuals shall contain the following 1 ) Instructions for the installation, operation and maintenance of the equipment 2) Wiring diagrams for electrical items and components. 3) List of replacement parts, with the name and part number of each, properly identified. 3.6 Protection to Fixtures, Material and Equipment: Bi -5 A. Tightly cover and protect fixtures and equipment against dirt, water and chemical or mechanical injury. Thoroughly clean interior and exterior of fixtures, materials and equipment at the completion of all work. 3.7 Service: A. Must have an organized service department, fully factory trained, capable of performing needed repairs within 24 hours of notification. Bi -6 APPENDIX B2: Operating Procedures, Preventive Maintenance, Training Requirements, and Periodic Verification Testing of Treatment Technology 1. Operating Procedures for the San-l-Pak Treatment Technology Bagged biomedical waste is brought to the San-l-Pak Treatment System in collection carts. An autoclave liner, which has a time/temperature sensitive indicator affixed to it is inserted into the chamber. A clamp ring is then used to hold the liner in place. Next, the chamber is placed in the load position. The red bags are then loaded into the lined chamber with the automatic cart dumper. After the chamber is loaded it is either dog-eared or fastened with a tie strap. The door is closed and the unit's cycle is initiated. After the waste is autoclaved, the door is opened and the chamber dumps the treated waste either into a dump cart or into a compactor via a conveyor. A. Loading and Operating 1. Load (with chamber liners, approximately 4 minutes) * Place chamber liner on chamber * Fold Chamber liner back over load door; place clamp ring over folded liner. . Load chamber, remove clamp ring, and fold excess liner into chamber. * Rotate chamber into the sterilization position. 2. Sterilization * Blue "Sterilize" button is activated. . San-l-Pak first pulls a vacuum with a minimum of 18 inches within the chamber. * Air removes during the vacuum stage is mixed with 3070 F. steam. • Steam is then injected into the sterilization chamber; chamber reaches a maximum of 38 psig. * After a temperature of 2700 F. is achieved; a 30-minute timer is automatically activated. * Chamber quickly reaches an ultimate temperature of 281° F - 2840 F. * Chamber is held in a high temperature, high-pressure environment for the full 30 minutes. * Upon completion of the sterilization cycle the chamber vents down. * Existing steam is piped to the condensate tank; it condenses and flows into the sanitary sewer. 3. Discharge * Open load door. * Activate "Dump" button. * Sterilized waste falls into a dump cart or onto conveyor belt. * Return to load position. 4. Disposal or Compaction o Once filled, waste in the cart is transported for disposal to a sanitary landfill. If a compactor is used, the cart is moved to the cart dumper/compactor and the cart dump/compactor button is activated. Most operations of a San-l-Pak System require a minimum operator interface. Operators are needed to load the unit, (cart dumping systems are available), close the sterilization chamber door, and to open the sterilization chamber door. Besides pressing a few buttons, no other operator interaction is required. B. Process Monitoring Each autoclave is equipped with recording devices, which automatically and continuously monitor and record performance and process parameters throughout the autoclave cycle. The autoclave's programmable logic controller is programmed to achieve the prescribed time, temperature and the process is reinitiated through another complete cycle. Through the telecommunication system, San-l-Pak, Inc. is also able to monitor the system from the factory upon your request. 2. Preventive Maintenance Maintenance of the autoclaves is performed consistent with the autoclave manufacturer's recommendations, which include the following schedule of maintenance activities and planned frequency below. Planned Frequency Month | Maintenance Activity Description 3 Examine door seals. Replace if necessary. 6 Check door clearances and operations. Adjust/Lubricate. 3 Check door safety operation. 6 Check and adjust loading/unloading mechanisms and equipment. 3 Check/calibrate temperature and pressure indicators 3 Test safety valves. 3 Check strainers and steam traps. Clean if necessary. 3 Check filters. Clean or replace as required. 3 Check all controls and indicator for proper operation. 3 Check recording devices for proper pull-down. 3 Test vacuum system for proper pull down. 6 Perform vacuum leak test. 3 Run all cycles while recording temperatures and pressures. 3 Check piping for leaks and valves for proper operation. 3 Check manual override for proper operations. 6 Check Battery for memory backup. The procedures are recorded on a data sheet, signed by the performing technician and autoclave-operating supervisor, and maintained in a logbook. B2-2 3. Training Requirements No person is permitted to operate an autoclave used to treat biomedical waste without first receiving training. The manufacturer's representatives provide training to all hospital personnel who are required to implement portions of the Operation Plan. All such training is documented. Copies of the documentation are maintained in the individual's personnel file at the hospital. The training includes the following: 1. Classroom instructions on: a. The types of waste that may and may not be autoclaved. b. Waste segregation procedures. c. Procedures for containing, handling, storing and transporting RMW. d. Procedures for containing, handling, storing and transporting hazardous waste, chemotherapeutic waste, antineoplactic waste and radioactive waste. e. Procedures for validation testing of the autoclaves. f. Procedures for the operation of the autoclaves. g. Procedures for handling spills. h. Procedures for dealing with emergency shutdowns. i. Challenge testing procedures. j. Maintenance procedures. k. Manifesting procedures. i. Certification procedures. m. Procedures for sealing the roll-off containers prior to transport to the facility. 2. Hands on Equipment Instruction for the staff responsible from the facility. a. Loading and unloading procedures. b. Validation testing. c. Operation of the equipment. d. Challenge testing. e. Emergency shutdown procedures, including unloading and decontamination of the autoclave and adjacent areas. f. Procedures for sealing the roll-off container prior to transport. 3. Periodic Validation Testing The San-l-Pak process should be monitored with a biological indicator. The use of the 3M 1276 Attest Steam Pack is recommended. This pack contains a biological indicator ampoule, indicator strips, and a record-keeping card. The indicator strips on the label and within the pack will change color to show the pack was indeed steam processed. The biological indicator located within the pack will show the ability of the San-l-Pak system to penetrate the barriers within the test pack, thus achieving sterilization. This pack is a simple and effective method of challenging the sterilization abilities of autoclave systems. Testing can be accomplished quickly and easily. During a normal waste processing cycle the 3M Test Pack should be placed in the chamber with the waste to be processed. The 3M 1276 Attest Steam Pack is designed to be B2-3 equivalent to a standard linen pack (12" x 12" x 20", 12 Ibs) which is recommended by the Association for the Advancement of Medical Instrumentation (AAMI). After removal from the San-l-Pak, the biological indicators contained within the 3M Test Pack are incubated at approximately 56 OC for 48 hours. After incubation, the ampoule visually indicates growth or no growth of the indicator spore. No color change means no growth and a high level of disinfection. B24