Environmental Management Plan (Emp) For

Clinical center of Montenegro

ENVIRONMENTAL MANAGEMENT PLAN (EMP) FOR

THE HERIC PROJECT

“HLA typing and HLA laboratory in Montenegro” (HLA - MNE)

-Draft-

Project Leader: prof. dr Marina Ratković

______

In Podgorica, June 2017

Contents

1.INTRODUCTION

1.1. Project description

2.ACTIVITIES IN HLA-MNE PROJECT BY WORK PACKAGES (WP-s) AND THEIR POSIBLE NEGATIVE IMPACTS ON THE ENVIRONMENT

3.DESCRIPTION OF ACTIVITIES WITH POSSIBLE AND WITH IDENTIFIED ENVIRONMENTAL IMPACT

3.1 Renovation of the laboratory

3.2 Laboratory works

4.LEGAL FRAMEWORK

5.PROPOSED PREVENTION A ND MITIGATION MEASURES

5.1. Measures for minor civil works on renovation of the laboratory

5.2. Measures during regular works of laboratory

5.3. Capacity building for HLA laboratory

ENVIRONMENTAL MANAGEMENT PLAN

Annex 1 Check list and EMP for minor civil works

Annex 2 Report on public consultation

1. INTRODUCTION

The Ministry of Science announced the Second Call for Research and Development Project Grants (CRDS) on May 20th 2014 and it was opened until September 19th 2014. After a two-stage of the external evaluation, the project of Clinical Center of Montenegro “HLA typing and HLA laboratory in Montenegro” (HLA - MNE), coordinated by prof. dr Marina Ratković is ranked as the highly recommended that will be funded over the next two years.

The project activities fall into screening category II (B) according to the World Bank rules and require development of the Environmental Management Plan (EMP).

1.1. Project description

CONSORTIUM

This proposal encompasses:

• Clinical Center of Montenegro (KCCG), RSRI[1]
• School of Medicine-University of Montenegro (MedF), RSRI
• Clinical Center of Zagreb (KC Zagreb), ISRI[2]
• R.O.S.E. GenTec Ltd. (ROSE), IL[3]

In total 3 scientific or high education institutions and one business partners are involved in HLA-MNE project.

SUMMARY (BACKGROUND OF THE PROJECT)

The project would have as a goal the establishment of resources and capacity in the health system of Montenegro for performing HLA typing and other immunological tests required for transplantation program in general and for HLA typing in general population. Introduction of HLA laboratory would have the importance for population HLA typing, diagnosis of other diseases, not only for the preparation and selection of patients for transplantation. Endemic diseases that occur in Montenegro could be traced and monitored in this way. It was planned that the project would take two years. It started in September 2015 to be finalized by September of 2017, but it should be extended for a year. In general, the project would include the adaptation of existing space of the laboratory for immunological research and purchase of the equipment and materials for laboratories performing HLA typing and its application, training and education of the staff and HLA typing for patients.

LOCATION OF THE PROJECT ACTIVITIES IN MONTENEGRO

All project activities will be done at the Clinical Center of Montenegro in Podgorica.

2. ACTIVITIES IN HLA-MNE PROJECT BY WORK PACKAGES (WP-s) AND THEIR POSIBLE NEGATIVE IMPACTS ON THE ENVIRONMENT

3. DESCRIPTION OF ACTIVITIES WITH POSSIBLE AND WITH IDENTIFIED ENVIRONMENTAL IMPACT

Activities with possible and with identified environmental impact from WP2 and WP4 will be implemented in the new-established HLA-laboratory in Clinical centre in Podgorica.

3.1 Renovation of the laboratory

WP.2.1- Adaptation of existing space of the Laboratory for immunological research; Here the key environmental safeguard issues are primarily related to civil works on renovation of the laboratory.

The premises for new laboratory is placed on the first floor of Clinical centre (Department for blood transfusion in previous period). The surface of the space is 135.85 m². Water supply and sewage system have been already installed, also ventilation and electricity; New equipment and connection will be adjusted following of the current installation. The heating system is in function, so there is need for changing of this installation. Air-conditioning is planned by using of multi- split system, also adequate ventilation of the rooms will be ensured. Interior works are planned only (plastering, tilling works, painting works etc).

3.2 Laboratory works

WP 4.1, 4.2., 4.3., 4.4 and 4.5 – immunological research in HLA laboratory; these are the activities related to regular works of the laboratory after renovation and equipping. Here the key environmental safeguard issues are primarily related to laboratory safety and disposal of waste.

The following material will be used during laboratory investigation:

• Blood samples (serum, blood with heparin, EDTA Blood)
• Tissue samples (lymph node, clips of the spleen)

The following laboratory procedures will be performed:

• Isolation of lymphocytes by density gradient centrifugation
• Test of microlymphocytotoxicity in micro titer Terasaki plate, including reading of the results by using of light microscope
• Isolation of DNA
• Amplification of DNA by using of PCR in the apparatus for amplification (thermocycler)
• Electrophoresis of amplified DNA fragments and reading of the results on UV table
• Luminex testings - PCR-SSO typing of antibodies and tests for determining of antibodies

The following chemicals and tests will be used: Lymphoprep, Hanks medium, serum AB, distilled water, physiological saline, trypan blue, rabbit complement, paraffin oil, ethanol, SDS, Proteinase K, buffers for isolation of DNA, PCR buffer, a buffer for electrophoresis, agarose, migration length marker, gel- red, serological tests for HLA typing, serological tests for the determination of antibodies HLA.

The list of laboratory equipment for HLA typization:

• High speed centrifuge
• Centrifuge
• Medical Laboratory freezer
• Medical laboratory refrigerator
• Automatic pipette, variable volume
• Automatic DNA isolation system
• PCR workstation
• Horizontal electrophoresis
• Thermalcycler
• Device for anti-HLA antibodies detection Luminex
• Fluorescent microscope
• Microscope adjusted for cross match
• Thermoshaker
• Vorthex mixer
• Camera with UV transilluminator
• Kits for PCR and post PCR
• Genetic analyzer sequenator with software

The standard working conditions are envisaged for the laboratory in terms of lighting , noise and space (there are no special requirements); air conditioning required in areas with apparatus (Luminex, PCR) and refrigerators. The devices should be connected on security socket (in case of a power failure, they immediately will be transferred to the generator).

Infectious waste will be generated from blood samples and everything that comes in contact with them. Radioactive and carcinogenic waste will not be generated. In addition, chemical waste and sharps will be also generated during laboratory works.

These activities do belong to the activities for which full Environmental Impact Assessment (EIA) is not required, in accordance with Law on EIA.

4. LEGAL FRAMEWORK

The proposal of the HLA in MNE project is made following the laws of Montenegro, rules of the World Bank and international guidelines. Montenegro, as a candidate for the Member State has imperative to harmonize regulations in the domain of public health and environment protection with EU legislative. In that sense three important drafts of environmental related laws were adopted, in accordance with EU directives:

 Law on Environmental Protection

 Law on Environmental Impact Assessment and

 Law on Integrated Prevention and Pollution Control.

Other applicable Montenegrin regulations:

 Law on Waste Management

 Law on Chemicals

 Law on Water

 Law on Health Care

 Law on Medical Means

 Law on Taking and Transplantation of Human Organs for Medical Treatment Purposes

 Law on Taking and Transplantation of Human Tissues and Cells for Medical Treatment Purposes.

Taking into account that the Project activities could induce the impacts that can be readily identified and standard preventative and/or remedial measures can be prescribed without a full EIA as per the Law on Environmental Impact Assessment, the Project corresponds to World Bank Category B and requires development of EMP. International Best Practice in Safety of Research Laboratories is also applicable for the project activities.

5. PROPOSED PREVENTION A ND MITIGATION MEASURES

There is a need for mitigation measures for the following activities:

WP.2.1- Adaptation of existing space of the Laboratory for immunological research; Here the key environmental safeguard issues are primarily related to civil works on renovation of the laboratory.

WP 4.1., 4.2., 4.3., 4.4 and 4.5 - related to immunological research in HLA laboratory. Here the key environmental safeguard issues are primarily related to laboratory safety and disposal of waste.

5.1. Measures for minor civil works on renovation of the laboratory

The premises for new laboratory is placed on the first floor of Clinical centre (Department for blood transfusion in previous period). The surface of the space is 135.85 m². Interior works are planned only (plastering, tilling works, painting works etc). Check list with the EMP for minor civil works have been prepared to be implemented during renovation works (Annex 1). This document should be a part of tender documentation for contracting of the civil works.

5.2. Measures during regular works of laboratory

For all activities in WP4 listed above, prevention and mitigation measures are needed. All planed actions in eliminating environmental impact will be on line with the legal framework and International Best Practice in Safety of Research Laboratories.

Chemicals and laboratory safety

In the HLA laboratory usual best practice in safety of laboratories will be used:

 Minimization of materials acquisition of hazardous.

 For chemical substances, Material Safety Data Sheets – MSDSs are available to all laboratory staff that is trained to handle them.

 Chemicals and tests are duly marked, stored in proper places with restricted access, available to the laboratory staff only, not on bench tops or lab hoods and not exposed heat or direct sunlight.

 In laboratory storage refrigerators will be in use for storing chemicals and tests for which it is necessary.

 Laboratory will have fire protection system.

 Laboratory personal will use appropriate personal protection materials/means to minimize exposure.

 The special care will be used when using sharps.

 In laboratory will be established good housekeeping with decontamination of work surfaces.

 In laboratory is forbidden eating, smoking, handle contact lenses, apply cosmetics, or take medicine.

 Access to the laboratory is granted to the authorised persons only.

 Expired chemicals, tests and other chemical waste are stored and kept before final disposal by licensed waste manager.

 Medical waste will be sorted in a special way, to be collected before final disposal by licensed company.

 Each device is marked with an inventory number and accompanied by registration sheet which specifies all the characteristics (date of procurement, servicing, position in laboratory etc.).

Additional measures that will be introduced into the working practices in HLA laboratory:

 On the laboratory appropriate warning signs and list of telephone numbers to call in case of accident will be placed.

 System for registration, reporting and treatment of injuries of staff members will be established.

 Guide for safe storage, handling and disposal of waste will be prepared.

Waste management

There is the system for collecting, segregation, treatment and final disposal of different types of waste that had been established in Clinical center of Montenegro earlier, in which new HLA laboratory will be included. Waste management plan developed by Clinical center (and approved by Environmental Protection Agency in December 2015) provides among other information about types of all generated waste and rules for management with each type of waste (collecting and segregation, storage, transport and final disposal). All waste produced in HLA lab will be treated on a proper way as it has already introduced in other laboratories of Clinical center.

The following types of hazardous waste should be generated during regular work of HLA laboratory: medical waste (infectious waste and sharps) as well as chemical waste. In addition different types of non-hazardous waste such as municipal waste will be generated to be disposed in municipal containers.

Medical and chemical waste

Medical waste such as infectious waste and all sharps that will be generated from blood samples and everything that comes in contact with them will be stored separately in special containers properly marked. Medical waste already segregated and marked is transported from the laboratories and other points to the Center for treatment of medical waste established by authorized company, which is located near the Clinical center. All the time, waste transportation and final disposal in the Center for treatment of medical waste is followed with proper evidence/documentation.

Chemical waste (expired chemicals and tests, packages of chemicals and tests etc) will be stored separately in special properly marked containers. This type of waste will be collected by authorized waste manager (the system has already been established for the Clinical center as a whole).

5.3. Capacity building for HLA laboratory

Guide for safe storage, handling and disposal of waste will be prepared. Laboratory should provide additional training in the fields of laboratory safety and waste management for all the laboratory staff members. Partner institution Clinical Center of Zagreb will transfer its knowledge to the Montenegrin partners about laboratory safety within WP3-Education of medical staff since they have extensive experience in that field.

ENVIRONMENTAL MANAGEMENT PLAN

A) MITIGATION PLAN

B) MONITORING PLAN

Annex 1

Checklist and EMP for Minor Civil Works on renovation of a part of the first floor within the