reap report annex3 bulgaria hospital

7/28/2019 Reap Report Annex3 Bulgaria Hospital

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Project Title:

Assistance in Developmentof National Plan forHospital WasteManagement: Bulgaria

PLAN

Sub-contractor:

URS Dames & Moore

Contract N:

OSS No: BL-0081.00-14.01

Project N:

DM.BL.14.01/HWM

Final Report

April 2002


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April 2002 Final Report National Plan for Bulgaria Hospital Waste

2

Address of the Sub-contractor: URS Dames & Moore

St Georges House5 St Georges RoadWimbledonLondon, SW19 4DRUKTel.: + 44 20 8944 3300Fax: + 44 20 8944 3301

Team Leader: Mr. Andrew WhitemanNational Team Leader Professor Aleksandar Spasov


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ABBREVIATIONS

HW Hospital Waste

SHW Special Hospital Waste

MHAT Multi-profile hospitals for active treatment

MoEW Bulgarian Ministry of Environment and Water

MoH Bulgarian Ministry of Health

MSWM Municipal Solid Waste Management

HWM Hospital Waste Management

PMG Project Management Group

PMCT (PCT) Project Management and Coordination Team

REAP Regional Environment Accession Project

SHAT Specialised hospitals for active treatment

ToR Terms of Reference

WHO World Health Organisation


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LIST OF USEFUL ADDRESSES

REAP project office Bratislava

Office address: Nmestie 1. Mja 11, (building of REGUS Centre)

811 06 Bratislava, Slovak Republic

Project Manager: Iksan van der PutteTel.: ++ 421 7 59 39 61 41Fax: ++ 421 7 59 39 63 16E-mail: [email protected]

European Commission

DG Environment

Ave. de Beaulieu 9, 1049 Brussels, Belgium

Principal Administrator Ian ClarkTel: +32 2 - 296 9517Fax: +32 2 - 299 4123Email [email protected]

DG Enlargement Unit: Implementation and ContractsRue de la Loi 200, B-1049 Brussels, Belgium

Task Manager SCR A2: Hendrik van MaeleTel.: +32 2 - 299 9071Fax: +32 2 - 296 8040Email [email protected]

Bulgarian Ministry of Environment and Water

22 Maria Louisa Blvd, Sofia

Directorate of Accession Strategies and EU Integration

Projects Leader: Slavitza DobrevaTel: +359 2 940 62 58Fax: +359 2 986 48 48E-mail: [email protected]

Waste Management Department

Specialist: Nikola DoytchinovTel: +359 2 940 62 58Fax: +359 2 986 48 48E-mail: [email protected]


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Consultant Contacts

Team Leader: Andy WhitemanOrganisation: URS Corporation Ltd. /wasteaware.org

Tel: +44 1442 253545Mobile: +44 7768 983321E-mail: [email protected]

Project Co-ordinator Razi LatifOrganisation: URS Corporation Ltd.Tel: + 44 20 8944 3300Fax: + 44 20 8944 3301E-mail: [email protected]


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CONTENTS

Executive Summary 8

Short-term (year 1-3)......................................................................................... Error! Bookmark not defined.Mid-term (year 3-7)........................................................................................... Error! Bookmark not defined.Long-term (year 7-10)....................................................................................... Error! Bookmark not defined.

1.0 Framework Principles ......................................................... .......................................................... ....... 11

1.1 Policy Priority ......................................................... ........................................................... ................ 111.2 Role of the National Hospital Waste Management Plan ............................................................ ........ 111.3 Objectives .......................................................... ................................................................ ................ 121.4 Waste Types Included in the Strategy................... ....................................................................... ...... 18

2.0 Existing Situation............................................................... ............................................................ ....... 20

2.1 Hospitals, Beds and Waste Quantities................................................................ ................................ 202.2 Existing Treatment Facilities ....................................................... ...................................................... 22

2.3 Administrative Framework and Skills Base..................... .................................................................. 232.3 Existing Arrangements for Waste Collection from Hospitals ............................................................ 252.4 Financial Resources ......................................................... ........................................................... ....... 25

3.0 Limitations ...................................................... ............................................................. ......................... 27

3.1 Practical constraints within existing hospitals.................................................................... ................ 273.2 Constraints related to preventing landfill ............................................................... ............................ 273.3 Closure of existing old incineration facilities ........................................................... ......................... 283.4 Limited financial resources................................................................. ............................................... 28

4.0 Options............................... ........................................................... ......................................................... 29

4.1 Improving segregation, handling and management systems within hospitals.................................... 294.2 Developing an integrated network of waste treatment facilities ............................................... ......... 30

4.3 Scenarios for development of treatment facilities and supporting collection infrastructure .............. 36

Scenario parameters and assumptions........................................................... ................................................... 36

Transport services ................................................... ........................................................... ................................... 38

5.0 Economic and Financial Assessment.......................................... ......................................................... 39

5.1 The Hospital Waste Collection, Treatment and Disposal Model ........................................................ ....... 39

Scope of the Analysis................................................................ ........................................................... ................ 39

Outputs from the Model ............................................................ ......................................................... ................ 39

Physical data and cost estimates ................................................................... ..................................................... 39

Waste Streams..................................................... ........................................................... ..................................... 40

5.2 Investment analysis ....................................................... ............................................................. ................ 40

Investment requirements........................... ................................................................ ......................................... 40

Operating costs................ ................................................................ ............................................................. ....... 41

Annualised costs ........................................................... .............................................................. ......................... 41

Present Values ........................................................... ................................................................. ......................... 42

Average Incremental Costs ....................................................... ......................................................... ................ 43

5.3 Affordability Analysis............................................................. ........................................................... ........ 44


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Unit costs...................... ........................................................... .............................................................. ............... 44

National Affordability................................. ........................................................... ............................................. 44

Affordability to Hospitals and the Population............................................................ ...................................... 45

5.4 Investment financing sources ............................................................. ........................................................ 47

6.0 Priority Measures and Targets .................................................................. .......................................... 49

6.1 Short-term (year 1-3) ................................................................ ......................................................... 49

Amendment of MoH guidelines ................................................................ ......................................................... 50

6.2 Mid-term (year 3-7) ......................................................... ........................................................... ....... 53

Strengthening institutional capacity..................... ..................................................................... ........................ 55

6.3 Long-term (year 7-10)................................ ................................................................ ........................ 56

7.0 Implementation Responsibilities...................................................................... .................................... 59

8.0 Implementation action plan .............................................................. ................................................... 62

9.0 Conclusions and recommendations ....................................................... .............................................. 64

Short-term (year 1-3)................... ................................................................ ..................................................... 66Mid-term (year 3-7)................. ................................................................ ......................................................... 66Long-term (year 7-10) ........................................................ ............................................................... ............... 66

ANNEXES

A Survey of Existing Hospital Waste Arisings

B Map Showing Regional Distribution of Hospital Beds

C Ministry of Health Guidelines

D Economic and Financial Model

E Legislative Framework

F Workshop


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Executive Summary

This national plan for hospital waste sets out a comprehensive framework for improvingwaste management practices in health care establishments across Bulgaria. Although it is

recognized that the function of hospitals is to provide quality health care services, effectivelymanaging wastes generated from these establishments will significantly reduce the risks ofinfection of hospital staff, waste collection workers and the general public, and protect theenvironment.

Precise actions will be determined at the local and regional levels, and the plan should beimplemented flexibly and in a step-by-step manner, learning from experiences and makingadjustments as necessary. It is believed that by focusing on the five key objectives of meetinglegal requirements, stopping the landfill of infectious waste, reducing health risks, minimizingemissions from waste treatment facilities and providing least cost solutions, practices can betransformed over a period of 10 years.

The estimated average incremental cost1 for the least cost scenario analysed (Scenario 2a) isEuro 429 per tonne of waste or Euro 40 per hospital bed per year. This represents an averagecost of Euro 0.11 (BGL 0.22) per bed per day. These costs are comparable (and lower) thanthose of similar systems in other European countries.

It is estimated that implementation of the least-cost option will command a maximum of0.04% of GDP in years 2005 and 2013. For all other years the proportion will be significantlylower (operating costs represent 0.01% of GDP). The affordability of the least-cost strategyto hospitals depends on how investment costs are to be funded and how the recurrent revenue

needed to sustain the service is to be generated.

The average cost/day per hospital bed of the least cost scenario is estimated to be BGL 0.22,or about Euro 0.1/bed/day. The range of costs/bed-year for the least-cost option (Euro 54-73)represents 1.5% 2% of current expenditures per bed. Although it is understood that hospitalsface significant financial constraints, the amounts involved are relatively small.

Assuming a population of 6.5 million (the analysis excludes Sofia), the annualised cost percapita for the least cost scenario, based on full cost recovery, is equal to Euro 0.5/capita/year.Measured as a proportion of the average per capita disposable income for 2002 (assumed to

be Euro 1,590), hospital waste management costs will only represent some 0.03% of

household income.

Although affordability is difficult to assess in isolation from information on other claims onnational resources, the proportion of GDP reflected by the proposed measures appears to berelatively small. These costs can be considered insignificant when weighed against the

potential health and environmental risk associated with not implementing effective hospitalwaste management systems.

1 Average incremental cost is an indicator of the average cost (combined investment and operating) over thelifetime of the plan (20 years)


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Priority measures and targets have been set out in the plan. In the initial period ofimplementation it is envisaged that around 8 regional autoclave facilities shall becomeestablished (subject to confirmation by regional plans). This is estimated to require aninvestment of Euro 4.9 million. Implementation needs to focus on ensuring that thesefacilities operate effectively and are fully utilized by hospitals.

Regional facilities offer significant benefits:

They are more cost effective through economies of scale; They allow optimum capacity to be provided for the wastes being generated; Future modification or expansion is less expensive; Operations are more efficient; Monitoring and supervision are easier than for dispersed facilities; Environmental monitoring and control are easier; Healthcare facility administrators can devote their full attention to the primary

activities of the healthcare facility.

In the medium term, the priority will be to re-assess plans, learn from experience during theinitial implementation period, and prepare for a further phase of investment to ensuredevelopment of a comprehensive network of regional facilities and supporting services. Thiswill allow existing sub-standard facilities to be closed, and eliminate the need for landfill ofthese wastes.

In the longer term, the priority will be to effectively regulate and control the health care wastemanagement system. Facilities will be designed and operated to established EU standards,and effective tracking procedures implemented to control wastes from the point of generation

to the point of treatment and disposal. In addition, focus will be placed on minimizing thegeneration of these wastes, further reducing environmental and health risks.

Specialized private sector operators will be invited to design, build, and operate regionalwaste facilities, and participate in contracts for waste collection and transportation services.Significant business and employment opportunities will therefore arise in the health carewaste management sector in the future.

The performance of services and treatment facilities will be overseen by regional and nationalauthorities. This will ensure that the services provided are technically appropriate, costeffective and well managed. The government will place attention on ensuring that it plays its

part in mobilising investments and ensuring satisfactory performance of health care wastemanagement services. Hospitals, in turn, must ensure that they carry out the tasks necessaryfor safe and secure delivery of these wastes from the wards to regional storage facilities.

The benefits of improving hospital waste management practices are significant. These wasteshave the potential to cause significant harm to human health and quality of the environment.Of all waste streams generated by society, effectively managing infectious hospital wastes isan area deserving high priority attention.

The actions and performance measures outlined in this plan represent the majorrecommendations for developing health care waste management practices. These

recommendations are summarised below:


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Short-term (year 1-3)

1 Establish a working group and hold consultations with deputy mayors and hospital managers2 Raise awareness of HCW issues and approaches raised through conducting training seminars

for hospital managers and other representatives of regional, municipal and private hospitals,

and polyclinics for all regions;3 Evaluate existing HCW management systems and management performance of regional,municipal and private hospitals, and polyclinics;

4 Include HCW management in training of medical management staff and in the curriculum ofmedical schools for nurses;

5 Establish an association of HCW management professionals;6 Consult with regions and hospitals on revised guidelines for hospitals;7 Integrate revised guidelines into the annual programme of the agency for environmental and

health protection;8 Prepare regional/municipal plans covering the entire network of Bulgarian health care

establishments;9 Evaluate regional plans and make decisions on investments and services to be provided;10 Implement training programmes for all health care staff11 Raise general awareness through poster exhibitions and other media in all hospitals12 Establish standard accounting procedures for health care waste management in all hospitals13 Establish a national database;14 Secure funding for initial priority investments;15 Prepare feasibility studies, tender documents and operational management plans;16 Procure and implement equipment and facilities.

Mid-term (year 3-7)

17 Re-evaluate and update waste management plans;18 Implement a comprehensive network of treatment facilities, treating infectious and other

HCW from all regional, municipal and private hospitals, and polyclinics;19 Make any necessary amendments made to legislation/regulations/guidelines establishing a

comprehensive normative base for HCW management;20 Ensure comprehensive use of operational management plans/procedures for HCW

management by all regional, municipal and private hospitals, and polyclinics;21 Establish 1 dedicated position in MoEW and 1 dedicated position in MoH covering HCW

management policy and guidance, and identify dedicated persons within each regionalinspectorate to fulfil regional tasks.

22 Work towards a target of 80% of HCW collection and transport operations provided by theprivate sector under franchise contracts;

23 Work towards a target of 50% of HCW treatment facilities being operated by the privatesector under service contracts.

Long-term (year 7-10)24 Ensure infectious and hazardous waste collected, treated and disposed to required standards

from all health care establishments;25 Inspect and monitor all HCW service providers and treatment facilities, and make records

available to the public;26 Eliminate the use of PVC as a packaging material in hospitals utilizing regional incineration

facilities for treatment of waste;27 Prepare hospital waste minimisation plans.28 Fulfil reporting requirements to the CEC.


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HOSPITAL WASTE MANAGEMENT PLAN FOR BULGARIA

1.0 Framework Principles

1.1 Policy Priority

The transposition of EU waste management Directives into Bulgarian law, and health reformslaunched in 2000, require a new approach to deal with the problems associated with wastefrom hospitals and other medical establishments2 in the Republic of Bulgaria.

The principal method of disposal for health care waste (HCW) is currently landfill. Ending theuse of landfill for the disposal of infectious waste is the major priority for Bulgaria and,therefore, the critical priority of the national strategy. Landfill of infectious waste is not

prohibited by Bulgarian law and EU Directives.

Effective changes to bring about a discontinuance of landfill of infectious waste rely uponimproving waste management practices within hospitals and other health care establishments.The Ministry of Health has already issued guidelines on the separate collection and temporarystorage of solid HCW, but strengthening the normative base for segregation and disposal ofHCW is imperative for reducing the risk of infection to hospital users and staff as well as the

population at large.

The availability of alternatives to landfill in Bulgaria (incineration, autoclaving, microwaving)is currently very limited. Development of an integrated network of treatment facilitiesrendering infectious wastes safe, and ensuring high standards of environmental protection

must be a key objective of the strategy in order to promote health and environmental safety.This will, of course, require a process of change in management practices and investment inequipment and facilities.

1.2 Role of the National Hospital Waste Management Plan

This strategy, in its final version, is intended to form a part of the National WasteManagement Programme3. This programme sets out the range of development priorities andactions necessary to ensure progressive and comprehensive improvement of HCWmanagement practices throughout Bulgaria, in order to protect the environment; reduce therisks to public health; and to harmonise standards throughout Europe.

In the context of the National Programme for Waste Management, the purpose of the hospitalwaste management plan4 is to:

2 For the remainder of this document the term health care waste (HCW) is used to cover wastes generated fromall medical establishments including hospitals, laboratories, polyclinics, veterinary establishments and dentists.3 The National Waste Management Programme is required by Section 2 Article 27 of the Reduction of theHarmful Impact of Waste Upon the Environment Act (1997).4In creating the framework for improved HCW management practices, this plan can be viewed as creating thestrategic framework for local actions and decisions. For this reason the term strategy and plan are used

interchangeably in this document, and indicate that at the national level it is possible only to establish broadprinciples and actions, leaving issues of detailed implementation to the regional and municipal authorities andindividual health care establishments.


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create a framework for implementation of new practices within hospitals; and develop an integrated network of treatment facilities to promote the highest

standards of environmental protection.

The primary purpose of hospitals is to provide quality healthcare services to the people of

Bulgaria. Waste management must be considered in this context. The strategy for HCWmanagement must provide a sustainable plan of development without adverse impact on the

primary purpose of hospitals. Through reducing the risk from infectious waste betweenpatients, to medical staff, waste collection workers and the general population, promotion ofimproved HCW management is compatible with this primary purpose.

It is essential that everyone concerned by healthcare waste should understand

that healthcare waste management is an integral part of healthcare, and that

creating harm through inadequate waste management reduces the overall

benefits of health care.5

1.3 Objectives

The guiding principle applicable to HCW is the Agenda 21 Waste Hierarchy adopted at theUnited Nations Conference on Environment and Development:

prevent or minimize re-use or recycle incinerate with heat recovery landfill the residuesFive objectives for development as part of a national strategy need to be considered:

Implementation of national legislation and EU Directives; Preventing the continued use of landfill for disposal of infectious waste and other

hazardous waste;

Reducing the risk of cross-infection to hospital users, employees and the generalpopulation;

Improving standards of waste treatment so as to reduce emissions. Providing appropriate health care waste management services at least cost

Objective 1: Compliance with national legislation, EC directives andinternational agreements

The Reduction of the Harmful Impact of Waste upon the Environment Act6 applies tohazardous waste7 including wastes for human or animal healthcare and/or related research8.Those relevant to hospitals are:

(a)waste from natal care, diagnostics, treatment or prevention of disease in humans;(b)sharps;5 Department of Protection of the Human Environment, WHO6 Ratified 18th September 19977 Article 2(1)(4)8 Annex 1, paragraph 18 00 00 to 18 02 04


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(c)body parts and organs including blood bags and blood preserves;(d)other wastes whose collection and disposal is not subject to special requirements in

view of the prevention of infection;(e)discarded chemicals.The legislation imposes responsibilities upon those conducting waste related activities.Articles 8 & 9 create the principles upon which financing of data collection relating to wasteand disposal are borne by the polluter or holder of the waste. Similarly, in respect oftreatment: The expenses for waste treatment and transportation shall be borne by thegenerators unless agreed otherwise9.

Chapter 3 Article 21 provides for the issuing of permits for operators concerned in thetransportation and treatment of hazardous waste and Chapter 5 regulates the granting of

permits; the import / export and transit of waste and the control of waste management.Punitive fines are within the scope of the legislation for violations of the statutory regulationof waste management in Bulgaria10.

Regulations on Treatment and Transportation of Industrial and Hazardous Waste11 set out therequirements for treatment and transportation of hazardous waste.

Framework DirectiveThe Framework Directive12 laid the foundation for effective management of waste bydefining waste, encouraging the reduction in waste production as well as the levels of harmfrom waste and placing a requirement on all EU member states to develop an integratednetwork of waste treatment and disposal facilities. Recycling of waste and use of waste as asource of energy without endangering health or the environment are fundamental principles to

be applied to waste management.

The principles of the Framework Directive apply to HCW as other waste types, indiscouraging the unnecessary movement of waste to encourage local proximity of waste fordisposal. A duty of care was created by the Framework Directive upon the holders of waste to

bring about effective responsibility to those concerned in the management of waste, whichapplies also to those responsible for healthcare services.

The polluter pays principle is contained in Article 15 of the Framework Directive. Althoughthis is of limited effect in the circumstances of waste from public healthcare provision, the

principle of responsibility being upon those who hold the waste is still applicable

The Hazardous Waste DirectiveThe objective of the Directive on Hazardous Waste13 is to approximate national legislation toensure that those who dispose of, recover, collect or transport hazardous waste do not mixdifferent categories of it or mix hazardous waste with non-hazardous wastes14 unless it mayimprove safe disposal or recovery without risk to the environment. The Directive requires that

9 Chapter 2, Article 1110 Chapter 6 Section 211 Decree No. 53 on the treatment and transportation of industrial and hazardous waste, 19th March 1999.12 75/44213 91/689. The EC adopted the Directive on Hazardous Waste on 12th December 1991 which replaced the 1978Directive 78/319 on toxic waste from 27th June 199514 Article 2.2


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hazardous waste should be separated where technically and economically feasible and wherenecessary to protect the environment15.

Registration, inspection and recording of waste management facilities originally required bythe Framework Directive16 are required also for documentary records of collection, transport,

recovery and disposal of hazardous wastes. Packaging and labelling are also required. To thisend, competent authorities should include details of recovery and disposal of hazardous wastein their waste management plans or have separate plans for the management of hazardouswaste available to the public.

Through reference to the Waste Framework Directive, the Hazardous Waste Directiverequires the establishment of an integrated network of hazardous waste treatment and disposalfacilities.

The relevant categories of hazardous waste for hospitals are17:

Anatomical substances which are infectious and hospital and other clinical waste; Infectious waste, defined as substances containing viable micro-organisms or their

toxins which are known or reliably believed to cause disease in man or other livingorganisms18,

Non infectious hazardous waste19.Directive on LandfillProximity of and self-sufficiency for the elimination of waste are underlying principles of theDirective on Landfill20. The objectives of the Directive are:

to encourage the reduction of landfill waste disposal;

reduction of hazardous waste disposal by landfill; to apply the polluter pays principle to landfill; to create monitoring of landfill sites and discourage dumping etc.; and to put technical standards in place for landfill use.Infectious hospital and other clinical waste are prohibited from landfill disposal by theDirective21.

Directive on the Incineration of WasteMinimum standards of requirements for incineration and re-incineration are prescribed by the

Directive on the Incineration of Waste22 encouraging the avoidance of trans-boundarymovement of waste for economic reasons. Plants for the purpose of incineration require

permits the content of which is prescribed by the Directive, which are to be granted only afterpublic consultation. The regulation of operators licensed for the purpose of incineration isrequired by the Directive, including monitoring of emission limits with annual reports.

15 Article 2.416 75/442/EEC17 Annex IA, Category 118 Annex III, Category H919 Annex I.A 2; I.A.4;Categories H1-14 (except H9) within Annex III .20 1999/31/EC21 Article 5(3)(c)22 2000/76/EC


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International AgreementsBulgaria has ratified, together with more than 100 countries, the Basel Convention on thecontrol of trans-boundary movements of hazardous wastes and their disposal which includesclinical waste from hospitals. Countries that signed the Convention accepted the principle thatthe only legal trans-boundary shipments of hazardous waste are exports from countries that

lack the facilities or expertise to dispose safely of certain wastes to other countries that haveboth facilities and expertise. This Strategy requires that hazardous HCW generated inBulgaria is transported, treated and disposed of within Bulgaria.

The legislative provision for the regulation of HCW is, therefore, prescribed according to thenature of the waste produced. Hospitals produce both municipal waste (similar in nature andcomposition to household waste) and hazardous waste for which a prohibition on landfillexists.

Objective 2: Stopping landfill of infectious and other hazardous HCW

According to Article 5 (paragraph 3.c) of Directive 1999/31/EC on Landfill, measures shall betaken to prohibit certain types of waste which present a risk to health, including clinicalwastes arising from medical or veterinary establishments, which are infectious as defined(property H9 in Annex III) by Directive 91/689/EC and waste falling within category 14(Annex I.A) of that Directive. In addition, it is stated that dilution of mixture of waste solelyin order to meet the waste acceptance criteria is prohibited.

Infectious waste is defined and categorised by the Directive on hazardous waste. Accordingly,chemical substances arising from research and development or teaching activities which arenot identified and/or are new and whose effects on man and/or the environment are not known(e.g. laboratory residues) are included in the category. The property of the hazardous wastewhich is infectious is a substance containing viable micro-organism or their toxins which areknown or reliably believed to cause disease in people or other living organisms.

In relation to hospitals, the EU Directives and national legislation prohibit the disposal ofinfectious waste and other hazardous wastes (pharmaceuticals and medicines) in landfills.This strategy seeks to put in place the framework and actions required to prevent the landfillof infectious and hazardous HCW.

Objective 3: Reducing health risks on hospital staff, patients and the widerpopulation

Hospitals are responsible for the safe management of hospital wastes. Hospitals have notalways appreciated the impact of its wastes on the community, and the local public worksdepartment are often unaware of the type of waste received from hospitals. Somemunicipalities prefer either to discontinue involvement in or to not become involved inmanagement of hospital wastes.

The potential health hazards and pollution effects of wastes may be categorised as follows:

1. Infectious wastes containing micro-organisms capable of causing illness to asusceptible host. Through this path, AIDS, hepatitis B, C and D, allergies,gastroenteric infections, respiratory infections, skin infections can be transferred.


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2. Toxic chemicals that can cause poisoning when inhaled ingested or brought intocontact with the skin.

3. Carcinogens (cancer-causing agents) in wastes from bio-medical research laboratories.4. Flammable liquids and explosive gases that can cause injury to personnel or damage to

the hospital structure by fire and explosion.

5. Packaged caustic materials (acids or bases) that can cause injury.6. Physically injurious wastes that can produce punctures, cuts, or abrasions.7. Radioactive contaminated wastes.

The following adverse effects can result from improper management of hospital wastes:human disease, animal disease, plant disease, toxicity to humans or animals, safety hazards,air pollution, land pollution, propagation of flies and other insects, propagation of rodents,odour, and unsightliness.

A priority objective must therefore be to prevent risks to patients, staff, visitors and the widercommunity. In order to achieve this, hospitals and other health care establishments must be

concerned with such hazards from the point of generation to the point of final treatment anddisposal. Improvement must be made in containing and confining wastes from the standpointof preventing fire, noise, and spread of micro-organisms. At various locations, the wastesshould be either reduced in volume or treated to eliminate their infectious/hazardous

properties.

Objective 4: Minimising emissions from waste treatment

Environmental standards of waste treatment processes have risen progressively in Europeover the last 15 years. The new incineration directive requires very high standards ofemissions control to be adopted for all such facilities, to make sure that use of suchtechnology gives rise to the minimum environmental impact. Other methods of HCWtreatment also generate emissions which must be controlled by application of pollutioncontrol technologies.

The issue of dioxin releases into the environment from incineration facilities has correctlyreceived strong attention from people and policy makers across Europe. The advice of theWorld Bank in relation to HCW treatment and dioxin emissions is highlighted in the box

below.


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Technology Choices and Dioxins23

Lower standard incineration facilities have a strong potential to give rise to unacceptableenvironmental impacts, which may directly affect the health of people living in close

proximity to these facilities. A major objective of this plan is to ensure that emissions fromwaste treatment facilities are minimised as far as possible, by implementing a mixture oftreatment technologies, progressively closing older facilities and ensuring that new facilitiesmeet standards established in the EC Incineration Directive.

Objective 5: Providing appropriate health care waste management services atleast cost

The priority of hospitals is to provide quality health care services. In the current economicclimate, it is critical for health care waste management services to be provided at least cost inorder to ensure that these services are affordable within the context of resources available tohospitals.

In order to ensure affordability, a network of health care waste treatment facilities should bedeveloped in a step-by-step manner, using technology which is compatible with local

professional and financial resources. Care should be taken to ensure that an over-supply oftreatment facilities is not developed.

23L M Johannessen et al. Health Care Waste Management Guidance Note. Urban Development Division, TheWorld Bank. May 2000

Currently, each technology that ensures destruction or elimination of infectious and othertypes of special HCW potentially produces a secondary waste stream. When choosing anappropriate technology (e.g., incineration, autoclave, or microwave irradiation) for the

type of HCW, a manager must review the secondary waste stream and the affectedpopulation.

Weighing the balance of the technology (and its secondary waste stream) with the currentproblem (while assessing the cost benefit and available technologies) is a key point indecision-making. Quite often, successful HCW management includes severaltechnologies within one facility.

Creation of dioxins (dibenzo-p-dioxins) are of particular concern due to the possiblecarcinogenic nature of these compounds. Incineration can create dioxins, depending onthe HCW material and the temperature (and scrubbers) of the incinerator plant. Plasticsand chlorinated substances (such as dyes) can create dioxins when incinerated. Therefore,segregation of materials is vitally important. Furthermore, ensuring that the incinerator

plant continually burns its materials at a temperature at or above 1200 degrees willvirtually eliminate dioxins from release.

Incineration remains an important technological tool in HCW management due to itsability to completely destroy infectious or contaminated materials (such as used syringes).In fact, in some instances, the public health threat from contaminated needles is of a muchgreater concern and probability than that of potential dioxins. Decision makers must makethe difficult choice for the greater good of the population in a particular time and place.


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1.4 Waste Types Included in the Strategy

The Bulgarian classification is implemented through the Reduction of the Harmful Impact ofWaste upon the Environment Act 1997 (RHIWEA) and the Ministerial Order No RD-323 of

1998 on the classification of waste as secondary legislation, which is based on the definitionsin the hazardous waste directive. These are:

Waste Type: Characteristics

Anatomical substances; hospital and other clinicalwastes which are infectious waste.

Other hospital and clinical wastes which are: Explosive; oxidising; highly flammable;flammable; irritant; harmful; toxic; carcinogenic;corrosive; teratogenic; mutagenic; or which releasetoxic or very toxic gases in contact with water, airor an acid; or which are capable after disposal ofyielding another substance to possess any of these

characteristics; or ecotoxic.Pharmaceuticals, medicines (and veterinarycompounds) which are:

Explosive; oxidising; highly flammable;flammable; irritant; harmful; toxic; carcinogenic;corrosive; teratogenic; mutagenic; or which releasetoxic or very toxic gases in contact with water, airor an acid; or which are capable after disposal ofyielding another substance to possess any of thesecharacteristics; or ecotoxic.

A worldwide recognised classification of HCW, useful for identifying and understandingwaste streams, has been established by the World Health Organization (WHO).

Health Care Waste (Hospital Waste)

1.Communal (Municipal) Waste is all solid waste not including infectious, chemical, or radioactive waste. Thiswaste stream can include items such as packaging materials and office supplies. Generally, this stream can bedisposed of in a communal landfill or other such arrangement. Separation of materials which are able to bereused or recycled will greatly reduce the impact burden of this waste stream.

2. Infectious waste: Discarded materials from health-care activities on humans or animals which have thepotential of transmitting infectious agents to humans. Such material result from diagnosis, treatment, orprevention of disease, assessment of health status or identification purposes, that have been in contact with bloodand its derivatives, tissues, tissue fluids or excreta, or wastes from infection isolation wards. Such wastes shallinclude, but are not limited to, cultures and stocks; tissues; dressings, swabs or other items soaked with blood;syringe needles; scalpels; diapers; blood bags. Sharps, whether contaminated or not, should be considered assubgroup of infectious HCW. It includes syringe needles, scalpels, infusion sets, knives, blades, broken glass.

3. Anatomic waste: Consists of recognisable body parts.4. Pharmaceutical waste: Consisting of/or containing pharmaceuticals, including: expired, no longer neededcontainers and/or packaging, items contaminated by or containing pharmaceuticals (bottles, boxes).

5. Genotoxic waste: Consisting of, or containing substances with genotoxic properties, including cytotoxic andantineoplasic drugs, genotoxic chemicals.

6. Chemical waste: Consisting of/or containing chemical substances, including laboratory chemicals; filmdeveloper; disinfectants expired or no longer needed; solvents, cleaning agents and others.

7. Heavy metals: Consisting of both materials and equipment with heavy metals and derivatives, including:batteries, thermometers, manometers.

8. Pressurized containers: Consisting of full or empty containers with pressurized liquids, gas, or powderedmaterials, including gas containers and aerosol cans.

9. Radioactive materials: Includes: unused liquids from radiotherapy or laboratory research; contaminated

glassware, packages or absorbent paper, urine and excreta from patients treated or tested with unsealed

radionuclides, sealed sources.


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Guidelines on which categories of waste should be considered to be infectious have beenproduced by the WHO24. The following categories of waste are listed:

Cultures and stocks of infectious agents from laboratory work; Waste from surgery and autopsies on patients with infectious diseases (eg

tissues, and materials or equipment that have been in contact with blood or bodyfluids);

Waste from infected patients in isolation wards (eg excreta, dressings frominfected or surgical wounds, clothes heavily soiled with human blood or other

body fluids);

Waste that has been in contact with infected patients undergoing haemodialysis(eg dialysis equipment such as tubing and filters, disposable towels, gowns,aprons, gloves and laboratory coats);

Infected animals from laboratories; Any other instruments or materials that have been in contact with infected

persons or animals.

Infected sharps are a subcategory of infectious waste which are classified as items thatcould cause puncture-wounds including needles, hypodermic needles, scalpel and other

blades, knives, infusion sets, saws, broken glass, and nails. Whether or not they are infected,such items are usually considered as highly hazardous HCW.

A few research institutes and specialist hospitals in Sofia (principally dealing with oncologyand cancer) produce radioactive wastes. Radioactive materials and wastes are separately

provided for by the Committee for the usage of nuclear energy for peaceful goals. Radioactivewastes are therefore not covered within the scope of this strategy.

24 Pruss A, Giroult E and Rushbrook P. Safe management of wastes from health care activities. WHO, 1999


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2.0 Existing Situation

2.1 Hospitals, Beds and Waste Quantities

Up to 1995 there was no national data on HCW quantities, due to the practice of collectingand disposing these wastes along with municipal waste. The lack of regulations concerningHCW management led to lack of priority focus and trained staff engaged with these issues.

There are four main types of hospitals with beds in Bulgaria:

multi-profile hospitals for active treatment (MHAT); specialised hospitals for active treatment (SHAT); psychiatry clinics; dispensaries.

Limited detailed information is available on infectious waste generated and managed inBulgarian hospitals. It is to be doubted that these statistics provide any reliable insight into thecurrent situation. However, some sources are available (based on data information abouthospital beds) which can serve as a prognostic guide to waste quantities.

A survey of the total number of beds for each type of hospital and the quantity of wastesgenerated per occupied bed from within Sofia has indicated that quantities of potentiallyinfectious and hazardous hospital wastes averages around 0.4 kg/bed/day. The likely quantityof wastes per day for different types of hospitals in Bulgaria can be estimated throughextrapolation of these data, factoring in a bed occupancy rate of 75%. Survey results are

presented in Annex A.

Type of

Hospital

Number of

hospitals

with beds

Number of

beds

Waste quantities

(kg/day)

(0.4 x number of beds)

MHAT 127 37,474 14,990

SHAT 73 12,186 4,874

Psychiatry clinics 11 3,075 1,230

Dispensaries 50 4,348 1,739

TOTAL 261 57,083 22,833


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The latest statistical information on regional distribution and types of hospitals comes from1999. In this year, 280 hospitals were functioning in Bulgaria with total number of 73,301

beds (87.7% hospital beds and including 12.3% sanatorium beds). Two tables showing thecorrelation of regions and no of beds (table 1) and types wards and no of beds (table 2):

Regions Beds (Number per

year) in regional

hospitals (1999)

( MHAT+SHAT)

Beds (Number per

year) in municipal

hospitals 1999

(MHAT )

Total 19,582 15,355

BlagoevgradBurgasVarna

Veliko TurnovoVidinVratzaGabrovoDobritchKurdjaliKustendilLovetchMontanaPazardjikPernik

PlevenPlovdivRazgradRuseSilistraSlivenSmolianSofia citySofia regionStara Zagora

TurgovishteHaskovoShumenIambol

5271031623

691642700651664474543663602814721

-705681867556781461Total 10,83825414796

5857301225827

843572340

1083204726442365263542523538542155

4661860350201356331427-11651056

440939461165

The above data on geographical distribution of beds are shown on the map in Annex B.

In addition to the beds shown in the above table, a total of 18,000 beds in Regional townshave been assumed.

25 Data obtained within the project `Incineration of Special Hospital Waste from Hospitals Located on theTerritory of Sofia prepared by dk-Teknik and Nedjin Ltd for the Ministry of Environment and Water.


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Wards in hospitals and policlinics Number of beds

Total 43,528

TherapyEndocrinologyRheumocardiology

NephrologyHaematologyGastroenterologyPhysiorehabilitationSurgeryOrthopaedics

NeurosurgeryUrology

OncologyGynaecologyPneumophysiatricInfectiousPediatricsMicropediatrics

NeonatologyWards for hypotrophic childrenOphthalmologyOtorhynolaringologyDermatovenerology

PsychiatryNeurologyObstetricsPathological pregnancyCommon bedsAnaesthesiology and intensive careHospicesOther specializedHome stationariesDay stationaries

5,9395601,134420130634671

4,4391,274231820

1,5371,9832,3331,5422,713640

1,026199812770777

1,8532,9481,70797368

1,64575967

1,966958

2.2 Existing Treatment Facilities

In Bulgaria, the existing installations for hospital waste incineration have been in use since the1970 - 1980. In general, they do not meet the present legal requirements and could not berenovated/upgraded. The existing hospital waste incinerators do not for allow the disposal ofall hospital waste generated and about 60 % of the hospital wastes are stored in open,uncontrolled depots. The latter situation creates serious health and environment risks.


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In practices, a considerable part of the hazardous waste is deposited together with municipalwaste, including discharge of infectious liquids, into the sewage system. The above mentioned

practice hides serious epidemiological risk for potential contamination and infecting of theleachate and the sewage system.

Within the present project, only the existing incinerator at the Military Hospital in Sofia hasbeen identified as a facility that might provide disposal of hospital waste in compliance withpresent legal requirements technical standards. The installation is of non-continuous type withcapacity of 200 kilograms per hour. Additionally, investments are required for the supply ofmonitoring and control equipment.

One further incinerator is being constructed in Sofia, in the area of the Aleksandrovskahospital. The facility is being constructed with the support of Danish grant funds. Theinstallation will have a throughput capacity of 400 kg per hour and should be in operation inthe beginning of 2003.

The capacities of the above incinerators allow the disposal of all infectious hospital wastegenerated on the territory of Sofia and additionally they might provide services to a muchlarger region.

2.3 Legal/Administrative Framework and Skills Base

The legal framework for management and control of health-care wastes is presented in AnnexE. Key features of the administrative framework and skills base are presented below.

The Ministry of Environment and Water (MoEW) is the competent authority, responsible for

the development and implementation of the national waste management policy. The Ministrycarries out part of these activities through the Executive Environment Agency (EEA), as well asthrough the network of 15 Regional Inspectorates of Environment and Water (RIEWs),which are the Ministrys specialized bodies for environmental control.

The Ministry of Environment and Water prepares and presents for approval to the Council ofMinisters a National Waste Management Programme and carries out the overall responsibilityfor its implementation. The Ministry prepares an Annual Report on waste management,which is included in the State of Environment Report. It participates in the financing of wastemanagement projects by providing grants and credits from the National Environmental ProtectionFund.

The Executive Environment Agency within the Ministry of Environment and Water carriesout monitoring and collects data on radiation, on waste, as well as on the quality of air, waterand soil in the country. Information on sites, which generate municipal, construction,industrial and hazardous waste, is collected and processed through the NationalEnvironmental Monitoring System.

RIEWs in cooperation with HEIs issue permits for hospital waste collection, storage andtreatment, for the activities performed on its territory. In case that the activities performed onthe territory of more than one RIEW, the permit have to be issued by MoEW. RIEWapproves the waste management programs prepared by hospitals, clinics, dentists practicesthat generate hospital waste and companies that collect, treat and/or dispose it.


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MoEW (RIEWs) keeps the register of issued permits and for the closed sites and activities.The RIEW shall control the observation of the conditions and requirements for wastedocumentation and reporting. The RIEW shall control the compliance with waste treatmentrequirements and with the conditions in permits concerning:

the generation, collection, storage, movement and treatment of waste;the facilities and installations for waste disposal;movement of waste within the RIEW territory;

The Ministry of Health sets the requirements for recovery of hazardous hospital waste,expired medicines and drug substances. Through the National Center on Hygiene, MedicalEcology and Nutrition, the Ministry of Health participates in the development of the nationallaboratory system for waste. It gives positions on the permits for waste management activitiesissued by the Ministry of Environment and Water.

Municipality mayors or persons, authorized by them, organize and control the activities

related to urban and construction waste generation, collection, storage, transportation andrecovery, as well as the implementation of the municipal waste management programmes.

The Municipal Councils adopt municipal waste management programs and regulations on theway of and conditions for collection, transportation, re-loading, storage, treatment andrecovery of the urban and construction waste generated on their territory. They also set localtaxes for waste collection, transportation and recovery.

The institutional framework for control/management of HCW is set out in the diagram below:

Ministry of

Health

Ministry ofEnvironment

and Water

Waste policylegislation,

regulations andsub-decrees

Hospitalmanagement/administration

Drafting

regulations

Ministry ofRegional

Developmentand Public

Works

RegionalHospitals

MunicipalHospitals

Regional

Inspectorates

PrivateHospitals

Regional

Inspectorates

Municipal

Government

Council of Ministers

Dispensaries/Psychiatry

clinics


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Despite the existence of a legal and administrative base, HCW management practices inBulgaria are randomised and not uniform throughout the country, with each region having itsown different practices and levels of awareness and attention to the issue.

There is a lack of national conception for addressing the problems of HCW, and an absence ofthese issues being considered with regards to the type of hospitals and health reforms in thecountry. Given the lack of established operational norms, regional inspectorates have beenunable to encourage and support systematic development of standards.

Within the skills base, there is an absence of purposefully trained and instructed personnel inthe hospitals dealing with the problems connected with wastes. The role of the hospitalmanagers is critical in this regard, and the performance of waste management in each hospitalcan, in part, be directly linked to the level of attention placed by managers to the issue.

2.3 Existing Arrangements for Waste Collection from Hospitals

Currently, the majority of hospital wastes being generated in Bulgaria are disposed to landfill.Hospitals have established individual contractual arrangements for the collection of waste(often mixed infectious and non-infectious) with the private sector. This has led to both a lackof control over the destination and professional standards of disposal of these wastes and alimited scope for investment in specialised collection vehicles.

2.4 Financial Resources

The National Health Insurance Fund (NHIF) is designed as a state monopoly. It has theexclusive right to grant mandatory health insurance and to guarantee the observance of theinsurance rights in respect of all nationals. This decision is based on subtle arguments.

The system is socially oriented and is one of the layers of social protection of the populationStarting 1 July 2000 the financing of curative medical care by the National Health InsuranceFund came into force. The health insurance financing by the NHIF in 2001 is a main way tofinance the hospital establishments as well. According to the Health Insurance Act hospitalestablishments are equally placed counterparts, irrespective of the nature of the property theyown. The new dominating source of financial resources will replace financing out of taxes fornearly 90% of the hospital establishments (in the current health expenditures part).

Another source for financing of the healthcare providers is the consumer tax according to Art.37 of the Health Insurance Act amounting to 1% of the minimal wage and payable with eachvisit to the doctor. A third source of financing of municipal and state owned curativeestablishments remains task subsidies and transfers from the state and municipal budgets forinvestment objectives, for execution of national and regional programs and other obligationsaccording to the Health Insurance Act and the Hospital Establishments Act. Together withthis, the role of the voluntary health insurance funds will grow as well, which, after thelicensing procedure is over, will function according to the requirements of the HealthInsurance Act.

There is limited amount of data on financial aspects relating specifically to HCWmanagement. Available data is limited to hospitals under municipality management.


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Available indices for hospitals activities are expenditures/per day /per bed. These data arepresented in the table below:

Year Expenditures/day/bed

(Bg leva)26

1992199319941995199619981999

179.50292.80436.6663.20114.3519.0022.10

Budgets for HCW management represent a small percentage of total expenditure. Required

budgets are determined independently for each hospital, and records are not available.

26 Expenditures have decreased over time as a result of the transitional health care reforms


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3.0 Limitations

3.1 Practical constraints within existing hospitals

Hospitals face a wide range of practical constraints in implementing improved wastesegregation, handling and storage systems, including:

Low level of attention and lack of clear understanding of requirements and optionswith hospital managers;

Space constraints within treatment rooms and wards; Availability of elevators to safely move waste around hospital premises; Lack of space for secure temporary storage of infectious waste; Lack of adequate ventilation in storage areas; Lack of refrigerators for low temperature storage of waste;

Availability of appropriate bins and packaging; Constraints on purchasing high quality equipment due to public procurement

procedures; and

Lack of materials/equipment suppliers in Bulgaria.Overcoming these constraints will require the development and implementation of normativestandards, and creative implementation of solutions, adapted to suit the particular situation ineach hospital and ward. The role of managers in inspiring development of appropriatesolutions and training of staff is particularly critical.

3.2 Constraints related to preventing landfill

The majority of HCW are currently disposed to land in uncontrolled disposal sites. Forseveral reasons eliminating landfill of these wastes represents a major challenge in Bulgaria:

There are insufficient practical alternatives available for land disposal ofHCW;

Existing contractual arrangements and contractors for collection anddisposal of HCW will need to be revised;

Many hospitals do not regard it as their responsibility to ensureenvironmentally-acceptable disposal of wastes generated.

The enactment of the Reduction of the Harmful Impact of Waste upon the Environment Act,the legal framework for controlling and effectively treating HCW in Bulgaria has beenestablished. However, there is a significant divide between the established legal requirements,and practice on the ground. Effectively implementing legal requirements will demand acomprehensive and systematic process of planning, facility development, contracting andregulation and control throughout Bulgaria.

Clearly these developments will take time to implement and must be done in a step-by-stepmanner in accordance with proper planning procedures, public consultation and availability ofinvestment finances and budgets to pay for services.

The limited availability of professional HCW treatment and disposal companies to provideservices across Bulgaria, and time required to put in place revised contractual arrangements


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will also constrain the pace of development. Only when the facilities and contracts are put inplace can the legal requirements be effectively enforced. The challenge of this strategy is tomap a path towards achieving the goal of eliminating disposal of infectious HCW to land.

3.3 Closure of existing old incineration facilities

In order to implement the standards required by the new EC incineration directive, many, ifnot all, of the existing incinerators will need to be closed down and replaced by modernfacilities. Although there may be some potential to retrofit gas cleaning systems on some ofthe newer incinerators, it is clear that a network of new treatment facilities (comprising a mixof technologies) will have to be planned and implemented.

When the existing facilities were developed, there was limited understanding of quantities ofwaste being generated. Improvement in the quality of data on the waste stream andunderstanding of the real problems must also be a part of the process of closure of the oldexisting incinerators. Again, this will require a step-by-step process of development, which

must first focus on the major centres of waste arising, where most of the environmental andhealth impacts focused. The challenge will be to phase out existing incinerators in a rationaland well-planned manner, maximising the productive usage of the more modern facilities in

place.

3.4 Limited financial resources

The extremely limited financial resources available to hospitals are perhaps the most criticalconstraint facing improvement of HCW management practices. The state of the economyover recent years has impacted significantly on hospital budgets, and it is clear that mobilisingsufficient finances and budgets to implement new management standards will be extremelydifficult.

Reflecting this, a major challenge for the strategy is to make sure that the requiredmanagement practices and treatment facilities are implemented as cost-effectively as possible.Amongst other options, regionalisation of treatment facilities, innovative solutions for internalmanagement systems and effective budgeting and financial management are criticalcomponents of the strategy. Avoiding an oversupply of treatment capacity through provisionof regional facilities in a step-by-step manner is a key priority.


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4.0 Options

4.1 Improving segregation, handling and management systems within hospitals

Improving the management practices for infectious and hazardous HCW within hospitals is apriority in Bulgaria. Existing practices vary widely between hospitals, in a large part as aresult of an insufficient and poorly established normative base.

The Ministry of Health has enacted guidelines (February 1998) on the separate collection andtemporal storage of solid hospital waste. These guidelines can be summarised as follows:

- Hospital waste that is considered non-hazardous must be collected in litter-bins withpedals or other containers. In annex 1 of the guideline the non-hazardous waste isdescribed.

- Hazardous (special) hospital waste as categorised in annex 2 of the guideline must becollected in plastic bags and labelled with a well visible sign dangerous waste No.43. Such bags have to be filled up to 2/3 capacity, tied up, and brought to a specialroom for temporary storage on a daily business. The temporary storage rooms musthave running water and walls / floor must allow washing and disinfection.

- A specifically assigned person for hazardous HW is assigned to ensure separation andtransportation of waste in the hospital. The route of transportation for the waste insidethe hospital should be different from routes taken patients. Only one of the existingelevators should be used for transportation of waste.

- A designated place for collection of non-hazardous / hazardous waste should be faraway from the building of the hospital and near the road. The area for the containers

for collection of non-hazardous hospital waste should be cement / asphalt covered,possibly inclined, and fenced with a lock. Containers must not leak and it must bepossible to close them tight. The area should also include a temporary storage forhazardous hospital waste.

- Transportation of hazardous hospital waste to an incinerator is carried out by adesignated person, who also is responsible for weighing the quantity of waste andcompleting the required report form. His duties include to keep the area for collectionof non-hazardous / hazardous waste clean.

Proposals for amendment and strengthening of these guidelines have been prepared within the

framework of this plan. These guidelines set out the detailed requirements for managementof all types of waste generated within hospitals and other health care establishments, and have

been designed to strengthen the normative base.

The guidelines contain instructions in the following areas:

Waste categorisation Waste separation Collection requirements

o onsite transporto labellingo transportation vehicles and containerso packaging and storageo transportation on public roads


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Treatment technologieso landfillingo incinerationo autoclavingo microwave and radiowave irradiationo chemical disinfection

Regulation and controlTreatment options are discussed in the following section.

4.2 Developing an integrated network of waste treatment facilities

Options for waste treatment

The choice of technology for waste treatment and disposal should always be driven by theobjective of reducing health and environmental impacts. The technology choice should also

be functional; safe; economically feasible; and sustainable. Choice of treatment/disposaltechnology needs to be made with cultural and religious sensitivities in mind. For example, inMuslim cultures within Bulgaria, anatomical waste (body parts) should be buried belowground.

A basic principle in all waste management schemes is to segregate wastes as early as possiblein the waste stream and to find the simplest solution for each type of waste. The first step intreatment and disposal is to ensure that all wastes similar in type and composition tomunicipal waste, and posing no health risks, is managed separately. The remaining wastes(infectious and other hazardous HCW) have characteristics that need particular treatment anddisposal. Major methods of treatment available and their relative advantages anddisadvantages are highlighted in the table below27.



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Available treatment technologies28

Type of Treatment Advantages DisadvantagesIncineration1) Batchincineration2) Dualchamber, or3) Rotary kiln(Destructiontreatment)

Elimination of health risks. Thewaste is non-recognizable

Fully destroys micro-organismsand sharps

Reduces volume/mass of thewaste

Destroys all types of organicwaste(liquids, pharmaceuticals, andother solids)

Heat recovery possible

High quantities of waste can betreated (except for batchIncinerator)

High investment costs

Complicated to operate

Continuous monitoringrequired

High maintenance, especiallyfor rotary kilns

Relatively high operationcosts; costs rise with the level ofsophistication of the emissioncontrols system

For batch incinerator: limitedcapacity

Emits toxic flue gases(including dioxins and furans;level varies). Currently there isno accepted level of emissionfor dioxins and furans, howeverEU standards provide a good

basis for comparison.

Generates residue that needssafe landfilling

Any residue generated may betoxic

SteamDisinfection:

Autoclave(Sterilization)

Simple to operate

A known technology athealthcare facilities

Relatively expensive to installand operate

Requires boiler with stackemissions controls

Relatively high maintenancecosts

Cannot be used to treat some

hazardous wastes,Pharmaceuticals, andCytotoxics

Requires separate andadditional packaging

Generates odors

Final disposal must be as foruntreated special healthcarewaste



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Generates contaminatedwastewater that needstreatment

Microwave:Microwave or radiowave

Irradiation (Disinfection)

The shredding process reducesthe volume of the waste (not

mass)

Highly sophisticated andcomplex

Relatively expensive to install

Only solids can be treated andonly when shredded

Cannot be used to treat someHazardous wastes,Pharmaceuticals, and Cytotoxics

Highly skilled operatorrequired

Expensive and difficult tomaintain

Final disposal must be same asfor untreated special healthcarewaste

Generates contaminatedwastewater that needstreatment

ChemicalTreatment:(Disinfection)

The shredding process reducesthe volume of the waste (notmass)

Cannot be used to treat somehazardous wastes,Pharmaceuticals, and

cytotoxics

Highly skilled operatorrequired

Expensive and difficult tomaintain

Final disposal must be same asfor untreated special healthcarewaste

Generates hazardous water

that needs treatment

A comparison of the technical requirements and performance of each technology in relation toa range of key criteria is presented in the following table.


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Performance of treatment methods against technical criteria29

(Broad comparisons, based on general experience individual examples will vary)

Typical Current Practices Typical Disposal Options properly operated

On sitedumps Openburning Municipal Dumps On siteincineration

Hightemperatureincineration

Auto-claving Micro-waving Chemicalsterilization

Elimination of

hazardous

characteristics

Destruction ofinfectiousorganisms

None Poor None Poor tomoderate

Very good Good Good Good

Destruction ofbody parts,blood etc

None Good None Good Very good Poor tomoderate

Poor tomoderate

Poor tomoderate

Destruction ofwastepharmaceuticals

None Good None Good Very good None None Poor tomoderate

Destruction ofsharps etc

None Moderate None Moderate Very good Poor tomoderate

Poor tomoderate

Moderate

Transformationof wastes

None Moderate None Good Very good Moderate Moderate Moderate

Controls on

processes

Assuredelimination ofhazards

None Verypoor

None Verypoor

Very good Moderate Moderate Moderate

Ability to copewith variations

Good Poor Good Poor Very good Poor Poor Poor

Environmenta

l impacts

Avoidance ofsecondaryimpacts

Poor Verypoor

Poor Poor Poor tomoderate

Poor tomoderate

Moderate Poor tomoderate

Prevention ofhuman access

Moderate

Moderate Verypoor

Good Very good Very good Verygood

Very good

Prevention ofcontaminationof land

Verypoor

Poor Verypoor

Good Very good Very good Verygood

Very good

Avoidance ofdisease vectors

Poor Poor tomoderate

Verypoor

Verygood

Very good Very good Verygood

Very good

Incineration is not the same as burning. Proper incineration is a highly advanced technologythat can adequately treat all types of hazardous HCW. The key parameters of controlledincineration are summarized as TTT: combustion at a sufficiently high temperature(between 1,000C and 1,200C in the combustion chamber) for a long enough time, in a

combustion chamber with sufficient turbulence and oxygen for complete combustion to beachieved and problematic gases to be minimized.

An incinerator requires skilled operators, extensive flue/gas emission controls and, frequently,imported spares and supplies. Properly controlled incineration is relatively expensive.Incineration of wastes generates residues, including air emissions and ash. Environmentalcontrols on incinerators in developed countries have been tightened in recent years,

principally because of concerns over air emissions of pollutants such as dioxins and heavymetals.



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The technology of small-capacity incinerators, for use by a single medical facility, is oftenrudimentary. These installations are not recommended, since they may constitute a serious air

pollution hazard to the surrounding area. Small incinerators that are not operatingsatisfactorily must be closed down when alternatives become available.

Incineration is an option for certain types of HCW (and is the preferred method for somesubstances such as cytotoxins and other pharmaceuticals) but it needs to be carefully operatedand controlled. The European Union has adopted emissions limits for medical wasteincinerators that include, among others, values for dioxins. Any new incinerators developedmust meet these standards in order for Bulgaria to proceed effectively towards compliancewith EU Directives.

Autoclavinginvolves the heating of waste material, with steam, in an enclosed container athigh pressure. At the appropriate levels of time (> 60 min), temperature (>121C), and

pressure (100 kPa) effective inactivation of all vegetative microorganisms and most bacterialspores can be achieved. Preparation of material for autoclaving requires segregation to

remove unsuitable material and shredding to reduce the individual pieces of waste to anacceptable size.

Small autoclaves are common for sterilization of medical equipment but a waste managementautoclave can be a relatively complex and expensive system requiring careful design,appropriate segregation of materials, and a high level of operation and maintenance support.The output from an autoclave is non-hazardous material that can normally be landfilled withmunicipal waste. There is also a wastewater stream that needs to be disposed of withappropriate care and controls. Furthermore, large autoclaves may require a boiler with stackemissions that will be subject to control.

At present, the use of autoclaving, chemical disinfection or any other non-destructivetechnology like microwave or radiowave irradiation is not allowed for the treatment of sometypes of HCW such as organs, tissues, or amputated human body parts. Incineration or burialare the only accepted techniques for the treatment of such types of HCW.

Microwave and Radiowave Irradiation involves the application over the wastes of a High-energy electromagnetic field that provokes the liquid contained within the waste, as well asthe liquid cell material of microorganisms, to oscillate at high frequency, heat up rapidly, andeventually cause the destruction of all infectious components of the waste.

The technique takes place in enclosed containers at atmospheric pressure and temperaturesbelow the normal water boiling point. The waste passes through a preparative process ofsegregation to remove undesirable material, then it is triturated, pulverized, and compressed

prior to its disinfection.

Similar to the autoclaving technique, the output from a microwave or radiowave facility isconsidered non-hazardous and can be landfilled together with municipal waste. Since thetechnology does not involve the application of steam, there is a minimal generation ofwastewater stream, and with the appropriate conditioning it can be recycled to the system.Since electricity is the main source of energy for operating this technology, gas emissions arealso minimal compared to incineration or even autoclaving, which requires the combustion of

fuel for the generation of steam.


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Chemical disinfection, used routinely in healthcare to kill microorganisms on medicalequipment has been lately extended to the treatment of HCW. Chemicals (mostly strongoxidants like chlorine compounds, ammonium salts, aldehydes, and phenolic compounds) areadded to the waste to kill or inactivate pathogens. This treatment is most suitable for treatingliquid wastes such as blood, urine stools or hospital sewage, but solid and highly hazardous

HCW like microbiological cultures, or sharps must undergo a relatively complex andexpensive preparative process of segregation shredding, and milling prior to the application ofthe chemical reagents. This technology requires special treatment of hazardous wastewaterstreams.

Land deposition of non-infectious HCW may be permitted. Landfilling should be performedin the same manner as solid industrial wastes; that is, in a pit excavated in mature municipalwaste at the base of the working face and immediately covered by a two-metre deep layer offresh municipal waste. Alternatively, a specially constructed small fenced landfill pit or

bunded area could be prepared on part of the site to receive only HCW. It should be coveredimmediately with soil after each load. For added health protection and odor suppression, it is

suggested that lime be spread over the waste. In both cases, it is essential to cover the HCWlayer well enough to prevent animals or scavengers from re-excavating it.

Landfilling must, however, be recognised as the final destination of post-treatment HCW ofhazardous and infectious types. Although waste generated from hospitals which is notinfectious may be landfilled, there should be a presumption that wastes may be infectiousunless it can be reliably determined otherwise.

Summary

Treatment of hazardous HCW in Bulgaria will need to be a balance between two principaloptions. These are the construction of new incinerators for HCW (which meet EU standardsof emissions control) and the application of other treatment methods. The most commonlyapplied alternative treatment methods are autoclaving and microwaving, however othertechnologies are available and should be considered. The residues from waste treatment must

be disposed at a controlled landfill.

Infectioushospital andother clinicalwastes (incl

research andteaching)

Non-infectioushazardous wastes

includingpharmaceutical &

medicines

Anatomical

waste

Municipal /domestic

waste

Waste transportation and/or treatment by incineration,

auto-clave, microwave , chemical treatment

Landfill

Disposal

Clinical assessmentof infection

Infectiousanatomical waste

Non-Infectiousanatomical waste

Burial,cremation,

etc.


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4.3 Scenarios for development of treatment facilities and supporting collection

infrastructure

Projected development scenarios

A range of development scenarios for implementing improved HCW management practices,and complying with legal requirements, have been projected. The scenarios have beenevaluated for their economic and financial performance (see Section 5 and Annex D)

It must be noted that these development scenarios are intended to be notional, ie they are notfixed statements of what will be developed, but options which represent a range of possiblesolutions.

The national plan will be implemented in close coordination between hospitals,municipal/regional authorities, national ministries and regional inspectorates. Decisions onwhich options to be employed will be made following more work at the local level, and

preparation of regional plans.

The following development scenarios have been projected and assessed:

- Scenario 1: Development of autoclave or microwave treatment facilities (andsupporting collection infrastructure) in each of the 27 administrative regions by 2005,and replacement with similar facilities in year 2013;

- Scenario 2a: Development of autoclave treatment facilities (and supporting collectioninfrastructure) for 9 groups of administrative regions by 2005, and replacement withautoclaves in year 2013;

- Scenario 2b: Development of autoclave treatment facilities (and supporting collectioninfrastructure) for 9 groups of administrative regions, and replacement with autoclavesand incineration facilities in year 2013.

Analysis of these development scenarios allows comparisons to be made about the relativeeconomic benefits of providing treatment facilities to serve larger regional catchment areas. In

practice the analysis provides a balanced assessment of the relative significance of capital andoperating costs compared to transport costs. The analysis also provides an indication of therelative economic performance of developing autoclaves rather than incinerators.

The main purpose of assessing these development scenarios is to identify whether

regionally located waste treatment facilities offer advantages over those at individualhealthcare facilities in treating HCW.

Scenario parameters and assumptions

General conditions and assumptions

1. The system will be organized on regional basis.2. The regions will be determined according to the administrative structure (28 regions).

Scenario 1 assumes that the number of installations is equal to the number of regions(2730). Scenarios 2 and 3 assume sharing of facilities between regions.

30 Sofia town and Sofia region will be considered as one region.


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3. The establishment of the hospital waste disposal system will be considered as a prioritywithin the general waste management policy.

4. Because of 3 the supply of equipment should start as soon as possible. The technologiesallowing shorter implementation period will be considered as a short-term option. Thenecessity of additional incineration capacities will be taken into account but the measures

will be

reap report annex3 bulgaria hospital

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