Health, Safety & Environmental Protection Office RESPONSIBILITIES AND ARRANGEMENTS FOR THE SAFE USE OF BIOLOGICAL AGENTS

Transcription

1 KING S COLLEGE LONDON Health, Safety & Environmental Protection Office RESPONSIBILITIES AND ARRANGEMENTS FOR THE SAFE USE OF BIOLOGICAL AGENTS Issue Date: Jun 2009 Issue Number: 1 Procedure No: SPR003 Author: Chris Bradley Approved By: Health & Safety Management Group CONTENTS 1 1 INTRODUCTION Overview Aims and Scope 2 2 DEFINITIONS 3 3 ORGANISATION AND RESPONSIBILITIES College Principal Heads of Schools Heads of Departments and Divisions Project or Laboratory Supervisor responsibilities Research Personnel and Students Biological Agents Safety Committee Biological Safety Supervisors 6 4 BIOLOGICAL AGENT RISK ASSESSMENT Biological Agent Risk Assessment Process Occupational Health requirements Emergency Requirements 9 5 FACILITIES AND EQUIPMENT Containment Laboratories Micobiological Safety Cabinets Waste disposal Personal Protective Equipment Training Spillage and Accident responses 11 APPENDIX A - REFERENCES 12 APPENDIX B - BIOLOGICAL AGENT RISK ASSESSMENT (LABORATORY) PROCEDURE 13 APPENDIX C CONTAINMENT LABORATORY FACILITIES 14 Table 1: Requirements for equipment and design for laboratories at different containment levels 14 Table 2: Requirements for equipment and design for activities with animals involving BAs 16 APPENDIX D KING S COLLEGE LONDON STANDARDS FOR CONTAINMENT LABORATORY EQUIPMENT 17 D.1 Containment Laboratories 17 D.2 Microbiological Safety Cabinets 17 D.3 Autoclaves 18 D.4 Disinfection and waste disposal 19 D.5 Centrifuges 19 D.6 Personal Protective Equipment 19 D.7 Training records 20 D.8 Spillage kits 20 D.9 Auditing and Monitoring 20 SPR HSEPO Page 1 of 20

2 1 INTRODUCTION 1.1 OVERVIEW This procedure expands upon the College s general health and safety and risk management policy. It defines governance and management responsibilities and the arrangements for the control of risks arising from the handling of biological agents (BAs) BA refers to a micro-organism, cell culture, or human endoparasite, whether or not genetically modified, which may cause infection, allergy, toxicity or otherwise create a hazard to human health. For the purposes of this procedure, it also refers to agents that can cause disease in animals The handling of BAs and activities involving BAs come under the scope of the Control of Substance Hazardous to Health (COSHH) Regulations, 2002, as amended This procedure is concerned with risks to the health and safety of persons directly and indirectly posed by BAs. It will cover activities where BAs may be used deliberately in research, experimental and teaching contexts and where BAs may be assumed to be present in other materials being used It is a collective and individual responsibility of those handling BAs to minimise the risks to themselves and others. Central to that responsibility is risk and control. Risk is a means of identifying hazards arising from the handling of BAs and minimising those hazards as far as is practicably possible This procedure is complementary to King s College London Policy and Advisory Note No. 4, College Activities Involving the Contained Use of Genetically Modified Organisms and any subsequent replacement procedure. 1.2 AIMS AND SCOPE This procedure is to ensure a consistent and integrated approach to activities involving the handling of BAs within the College. The aims of this policy are to document specific responsibilities of groups and individuals to safely manage the risks posed by the use of, or incidental exposure to, BAs and to provide minimum standards for the provisions to adequately control the risks posed by BAs This procedure applies to facilities controlled or occupied by the College or elsewhere if the activity is under the direction of the College. This includes any activity where BAs are handled e.g. environmental sampling, research or teaching. Activities undertaken elsewhere in the UK or abroad, including that undertaken in embedded space within Hospital Trust premises, also fall within the scope of this policy if these are under the control or direction of College staff. SPR HSEPO Page 2 of 20

3 2 DEFINITIONS In this Safety Procedure and Advisory Note the following definitions apply: Approved List refers to the classification of specific BA s into Hazard Groups by the Advisory Committee on Dangerous Pathogens (ACDP) available from the HSE: Biological Agent (BA) means a micro-organism, cell culture, or human endoparasite, whether or not genetically modified, which may cause infection, allergy, toxicity or otherwise create a hazard to human health. For the purposes of this procedure, it also refers to agents that can cause disease in animals, currently classified in the DEFRA Specified Animal Pathogens Order (SAPO) listings, and diseases of plants. Biological Agent Risk Assessment (BARA) is form HSEPO(F008) to be used to assess the risks associated with biological agents being handled within the College or within samples where biological agents may reasonably be expected to be present. Containment Level (CL) is the system of working to protect operators and other personnel from exposure to BAs based upon work practices and physical control measures. For specific details refer to Schedule 3, Part II, Control of Substances Hazardous to Health ACoP, Enforcing Agency refers primarily to the Health and Safety Executive but may also refer to the Department for Environment, Food and Rural Affairs (DEFRA) and the Home Office. Genetic Modification (GM) means the altering of the genetic material of an organism in a way that does not occur by mating or natural recombination. Hazard Group (HG) refers to the classification of BAs under COSHH into one of four groups based on their ability to infect healthy humans. Classification is based on the following criteria: o whether the agent is pathogenic for humans; o whether the agent is a hazard to employees; o whether the agent is transmissible to the community; and o whether there is effective treatment or prophylaxis available. The four HGs are defined as: o HG 1: unlikely to cause human disease; o HG 2: can cause human disease and may be hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available; o HG 3: can cause severe human disease and my be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available; o HG 4: causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available. Work must only be performed in CL laboratories of the corresponding level unless specifically derogated i.e. HG 2 BAs must only be worked with in laboratories rated at a minimum of CL 2 unless derogated. HSEPO is the College s Health, Safety and Environmental Protection Office. Human Tissue refers to material consisting of, or including human cells, with the exception of: embryos outside the human body, hair or nail of a living person or extracted DNA. Laboratory personnel are personnel working in laboratories including research personnel, visiting research personnel, research students, technicians and may include cleaning staff. It SPR HSEPO Page 3 of 20

4 refers generally those who may be directly exposed to biological agents in the course of their routine work. Notifiable HG2 agents include all strains of the following bacterial species: Bordetella pertussis, Corynebacterium diptheriae and Neisseria meningitidis. Organism means a biological entity capable of replication or of transferring genetic material and includes a micro-organism but not a human or human embryo. Note: Micro-organisms include bacteria, fungi, viruses, viroids, transmissible spongiform encephalopathies, cell cultures and tissues cultures whether derived from animals, humans or plants. Personal Protective Equipment (PPE) refers to protective clothing and other equipment worn by individuals as a last line in safe handling of BAs. Primary human tissue refers to unfixed tissues or samples obtained directly from human beings. These must be treated as HG2 requiring CL2 facilities for handling due to the unknown infectious status of the materials. Specific Animal Pathogen Orders (SAPO) refers to animal pathogens listed under the Specified Animal Pathogens Order, 2008 including: o intact pathogens; o pathogens attenuated by any means or genetically modified by any means; o any nucleic acid derived from an animal pathogen listed in the Schedule which could produce a pathogen when introduced into a biological system in which nucleic acid is capable of replicating (this is beyond the scope of this safety procedure). HSEPO2009(SPR003) Issue 1 Page 4 of 20

5 3 ORGANISATION AND RESPONSIBILITIES The organisation necessary to implement this safety procedure depends on a delegation of defined tasks and functions to those responsible for research or experimental projects or other activities in which BAs are to be used or may be encountered. Local arrangements may vary but these arrangements must provide an equivalent coverage of responsibilities. 3.1 COLLEGE PRINCIPAL The College Principal and the senior management team have overall responsibility for ensuring the College is compliant with COSHH regulations with regards to activities involving BAs and for determining and monitoring the effectiveness of this policy. 3.2 HEADS OF SCHOOLS Heads of Schools have responsibility for the health and safety of their staff and other persons who may be affected by the work conducted within their Schools Heads of Schools must ensure that the policy for activities involving BAs is enforced. 3.3 HEADS OF DEPARTMENTS OR DIVISIONS Heads of Department and Divisions (HoD), dependent on local arrangements, have responsibility for the health and safety of their staff and other persons who may be affected by the work conducted within their departments HoD must read the risk s for the BA activities being conducted within their departments and confirm that the s provided are suitable and sufficient HoD must confirm that the proposed BA activities will be conducted in facilities that are suitable HoD must confirm that all relevant regulatory requirements for BA activities are met. 3.4 PROJECT OR LABORATORY SUPERVISOR RESPONSIBILITIES Supervisors have a personal responsibility for their own health and safety and that of other persons who may be affected by their work including postgraduate students, research assistants, ancillary staff and contractors Supervisors must provide information on the known hazards and potential risks associated with BAs and instruct those they supervise in safe working methods and the use of control measures. Such information and instruction must be made available as a code of laboratory practice, laboratory protocol or standard operating procedure incorporating the risk conclusions Supervisors must assess the risks associated with the BA activity to identify the appropriate containment level (CL) and any other precautions. The conclusions and decisions of that must be recorded in accordance with College procedures. Advice or guidance on completion of the Biological Agent Risk Assessment (BARA) form is available through the Health, Safety and Environmental Protection Office (HSEPO) website and further advice can be obtained from local Biological Safety Supervisors or the College Biological Safety Officer Supervisors must ensure that adequate containment measures as determined by risk are provided and used appropriately by personnel, including the use of microbiological safety cabinets (MSCs) and personal protective equipment (PPE) Supervisors must determine the training requirements of all personnel to ensure BAs are handled safely. SPR HSEPO Page 5 of 20

6 3.5 RESEARCH PERSONNEL AND STUDENTS Research personnel and students have a responsibility for their own health and safety and that of other persons who may be affected by their work Research personnel and students must attend any training sessions deemed necessary and must adhere to any safety instructions given Research personnel and students must use control measures when supplied including wearing suitable and appropriate PPE Research personnel and students have a duty to report to their line managers any unsafe situations involving BAs. 3.6 BIOLOGICAL AGENTS SAFETY COMMITTEE BA Safety Committees must be established to advise on BA activities involving Hazard Group 3 (HG3) or HG2 agents that require enforcing authority notification, refer to Section for when notification is. The Committee may advise on activities involving nonnotifiable HG2 agents if deemed necessary. The Committee may be School specific, may encompass more that one School or may be site dependant. It is for Schools to decide an appropriate arrangement The composition of the Committee, whether dedicated to BA risk management or with other functions, should be so constituted so that it is competent to advise. The Committee may be the same as that set up to advise upon Genetic Modification Risk Assessments (GMRAs) and may discuss both GMRAs and BARAs at the same meeting. Members should be drawn from those who manage or supervise the work and those who may be exposed. The Committee should have sufficient knowledge and experience of BA activities and their associated human and environmental hazards and risks to be able to make valid comments on the adequacy of the and its conclusions The College Biological Safety Officer must be an ex officio of School Committees whose remit includes BARAs. If BARA discussion is part of a wider role of the Committee, e.g. as a general School Health & Safety Committee, the College Biological Safety Officer must be present for that part of meeting when BARAs are discussed. Biological Safety Supervisors should also be ex officio members and Trades Union Safety Representatives must have the right of attendance if they so wish Committees should meet as often as necessary to avoid creating undue delay in the processing of BARAs and proposals. They must keep and distribute minutes and papers including BARA forms in good time to enable members to seek further information. Where appropriate, copies of minutes should be forwarded to the School Health & Safety Committee Supervisors who submit a BARA for review by the Committee, if not a member of the Committee, will be to attend the meeting or provide a suitable deputy to respond to any queries that arise Where BA activities are to be jointly supervised by Schools, the should be submitted to the Committee for that School where the work is intended to be done. Similarly, for BA activities to be undertaken by a School and another organisation that is a registered BA centre, e.g. NHS Trust, the BARA should be submitted to the Committee that advises the organisation that has management control of the work. Schools and other organisations should co-operate and co-ordinate to enable consist safe practices when BA activities are to be conducted on more than one site Committees constituted to advise on BARAs should also review the general arrangements for BA work within the School and the levels of training and competence of BA workers. Reports from safety inspections should be considered when determining the appropriateness of facilities for BA projects. 3.7 BIOLOGICAL SAFETY SUPERVISORS Heads of Schools must satisfy themselves that appropriate organisations and arrangements are in place within each Department, equivalent unit or research group to meet both the legal duties and College policy for BA activities. Biological Safety Supervisors (BSSs) must be appointed to assist the relevant Heads to meet these requirements. Appointments should be HSEPO2009(SPR003) Issue 1 Page 6 of 20

7 confirmed in writing setting out the laboratories or activities for which the appointee has responsibility and should be notified to the College Biological Safety Officer and School Safety Advisor / Manager BSSs advising on BAs may not necessarily be the same individuals appointed to advise upon Genetic Modification matters BSSs will have sufficient delegated authority to act directly for the Head of School. If the role is combined with other duties, they will also need sufficient time to discharge these tasks and attend training BSSs must be competent and experienced in laboratory work with BAs. They will need to know the relevant statutory requirements and College procedures that apply to the work that is done (this aspect will be addressed in BSS training) Duties will be agreed in writing and typically will include: Ensuring that supervisors provide adequate information and instruction to new staff and students before embarking on BA activities; Ensuring, in collaboration with the College Biological Safety Officer, that information on safety training for BA workers is provided; Ensuring that new workers are advised of health screening or surveillance requirements in accordance with risk s; Ensuring that College, School and local procedures are implemented; Ensuring, in collaboration with the College Biological Safety Officer, that regular inspections of BA containment laboratories are carried out; Ensuring that engineering control measures, such as microbiological safety cabinets, and other protective equipment are appropriately tested and maintained and that records are kept; Ensuring, in collaboration with the College Biological Safety Officer, that appropriate decontamination and decommissioning procedures are undertaken when BA laboratories are vacated; Ensuring that a register of BA workers working with HG3 agents is maintained which includes the BAs that each worker is involved with and to provide an annual list of workers to the College Biological Safety Officer for retention; Ensuring that a list of laboratories where BAs are used or kept and a named contact person(s) is provided to local Site Services or security for use in the event of an emergency; In the absence of a Biological Safety Supervisor, Heads of Departments, units and research groups are responsible for delivering the duties listed above Where a BSS does not feel suitably experienced to advise upon work involving a specific BA, another BSS with more relevant knowledge and experience may be requested to advise. HSEPO2009(SPR003) Issue 1 Page 7 of 20

8 4 BIOLOGICAL AGENT RISK ASSESSMENT 4.1 BIOLOGICAL AGENT RISK ASSESSMENT PROCESS Biological Agent Risk Assessments (BARAs) must be completed for activities where BAs are to be handled or may be encountered. This form is intended for biological experimental, research or training activities Laboratory activities BARAs can be completed in numerous fashions as appropriate: providing details of activities involving individual BAs within the confines of a particular laboratory. providing details of activities involving individual BAs in general usage within several laboratories. providing details of activities involving several BAs with similar hazards in general usage in one or several laboratories. Activities involving BAs that require enforcing authority notification (all HG3 agents and a small number of HG2 agents) must be completed on individual forms for each agent. Activities involving HG4 agents will not be allowed on College property or facilities. Refer to Appendix B for a summary of the risk procedure The Proposer, who may be a supervisor or other appropriate person, must seek advice from the local Biological Safety Supervisor for completion of the form and ensure the BARA is suitable and sufficient For activities involving HG1 or HG2 agents that do not require enforcing authority notification, the completed risk form must be signed by the Proposer, the advising Biological Safety Supervisor and the Head of Department Where the BARA deems the work to require higher containment levels and / or involves BAs that require enforcing authority notification, copies of the completed risk pro forma are to be forwarded to the College Biological Safety Officer and the Committee set up to discuss BA risk s via the Committee Secretary In the event that a BARA is not accepted, the form will be returned to the supervisor with the views of the committee and information on the improvements for approval. Work cannot proceed without the approval of the committee Once the Proposer, the advising Biological Safety Supervisor and the Head of Department have signed the BARA, a representative of the Committee (normally the Chair) will sign the BARA form if it accepts the risk and send the form to the College Biological Safety Officer. The College Biological Safety Officer will notify or request consent for the work to the enforcing authority. Work can begin only when all approvals and consents have been given The original BARA must be retained by the School Safety Manager. Copies of the completed BARA form are to be forwarded to the advising Biological Safety Supervisor and to the Proposer. The College Biological Safety Officer must also retain a copy of BARAs involving notifiable BAs Copies of the BARA are to be made available to personnel who may be exposed to the BAs in the locations described. 4.2 OCCUPATIONAL HEALTH REQUIREMENTS Occupational Health (OH) will need to be consulted for further medical requirements if deemed necessary by the BARA All laboratory personnel working with primary human tissue, including blood and bodily fluids, must be offered vaccination against Hepatitis B. Taught students will be offered vaccination if they are expected to be handling primary human tissue as part of their course Health surveillance will be implemented if determined as necessary by the BARA and OH recommendations Pre-employment health screening is necessary to determine the suitability of individuals for working with particular BAs. This will provide a baseline reading against which future readings may be compared. OH must be provided with a copy of the BARA for the project(s) on which the individual will work. SPR HSEPO Page 8 of 20

9 4.3 EMERGENCY REQUIREMENTS A procedure for containing and cleaning spills is for all facilities where BAs are handled. The BARA will determine the actual procedures in the event of spillages which all personnel should be trained in The College BSO must be advised of any spillages or accidents involving primary human tissue, notifiable HG2 or HG3 BAs through the College accident reporting procedure In the event of an injury involving exposure to a BA (e.g. contaminated sharps, splashes to eyes or mucous membranes, inhalation etc.), Occupational Health must be contacted for advice or, if the injury occurs out of hours, the injured person must be taken to Accident and Emergency as soon as possible or within 24 hours. The injury must be reported through the College accident reporting procedure. HSEPO2009(SPR003) Issue 1 Page 9 of 20

10 5 FACILITIES AND EQUIPMENT Where deliberate BA activities are to be conducted on College premises all facilities and equipment must be maintained to ensure continued functionality and containment. When handling materials where BAs may be assumed to be present appropriate measures, as determined by BARA, must be used and requirements adhered to. Refer to Appendix D for information on the College s minimum requirements for facilities and equipment. 5.1 CONTAINMENT LABORATORIES Deliberate BA activities must only be conducted in laboratories or facilities with suitable containment level (CL) as determined by risk Containment facilities must incorporate a minimum of those requirements as defined by the COSHH regulations. Refer to Appendix C for details of containment requirements and Appendix D1 for minimum College requirements During the design of new or refurbished facilities, the HSEPO should be consulted at as early a stage as possible (on or before project stage C) to advise on the requirements and suitability of the planned construction works Laboratories must have sufficient space to allow personnel to work comfortably and safely for the tasks performed In some circumstances, it may be appropriate to derogate the CL requirements for specific BA activities, these must be specified in the BARA with the reasoning why derogation is appropriate Activities involving animal pathogens may require greater CL requirements than for protection of human health. The DEFRA SAPO listings must be consulted prior to risk. Advice and information can be obtained from the College Biological Safety Officer Activities involving plants and agents that may cause plant disease may require specific control measures. Advice and information can be obtained from the College Biological Safety Officer. 5.2 MICOBIOLOGICAL SAFETY CABINETS Microbiological Safety Cabinets (MSCs) must be used as by the risk. The class of MSC used should be based on the requirements for operator protection and project sterility. The class of MSC is not determined by the CL requirements or the HG of the agent being handled. For further information on MSCs refer to Appendix D MSCs must be used in accordance with the manufacturer s instructions. 5.3 WASTE DISPOSAL Refer to Appendices D3 and D4 for information 5.4 PERSONAL PROTECTIVE EQUIPMENT Minimum requirements for PPE must be determined by risk and must be suitable for the work being carried out Refer to Appendix C for the minimum requirements for PPE at each containment level and Appendix D6 for College requirements. 5.5 TRAINING All laboratory personnel must receive training and instruction in the techniques and local laboratory procedures they will be using when they start employment at King s or before commencing work in a new department. Refresher training should be given a minimum of triennially. Training records must be kept up to date and signed by trainee and trainer when SPR HSEPO Page 10 of 20

11 both parties are satisfied that standards of competence have been met. Refer to Appendix D7 for further information regarding training requirements for working with BAs Research students must not work un-supervised for their first year in the laboratory until they have demonstrated competence in working in the laboratory environment and are authorised to do so by the Project or Laboratory Supervisor or other suitable manager Training records for personnel working at CL3 must be stored for 40 years after last exposure to the HG3 agent. 5.6 SPILLAGE AND ACCIDENT RESPONSES Spillage kits must be available and readily accessible in all laboratories working with BAs. Contents should be regularly checked and replaced on usage or expiry. Refer to Appendix D8 for further information The BARA will include actions in the event of spillage or reference to local procedures. All laboratory personnel must be trained in spillage procedure. HSEPO2009(SPR003) Issue 1 Page 11 of 20

12 APPENDIX A - REFERENCES The Approved List of biological agents, Advisory Committee on Dangerous Pathogens: Approved Code of Practice and Guidance: Control of Substances Hazardous to Health (5 th edition), The Control of Substances Hazardous to Health Regulations 2004 (as amended), Health and Safety Executive. Biological Agents Risk Assessment Laboratory Work Form, HSEPO2009(F008). Guidance notes on Biological Agents Risk Assessment Laboratory Work, HSEPO2009(GF002). Biological Agents: Managing the risks in laboratories and healthcare premises, Advisory Committee on Dangerous Pathogens, Health and Safety Executive (2005) BS EN 12128:1998 Biotechnology. Laboratories for research, development and analysis. Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements. BS 3202 Laboratory Furniture and Fittings Part 3: 1991 Recommendations for design. Environment and sustainability, Health Technical Memorandum 07-01: Safe management of healthcare waste, Department of Health, HSE infections at work & GM home page: The Management, Design and Operation of Microbiological Containment Laboratories, HSE Books, Safe working and the prevention of infection in clinical laboratories and similar facilities, 2 nd edition, 2003, Health Services Advisory Committee, HSE Books. Specified Animal Pathogens Order licence application form: Statement of General Policy, Responsibilities and Arrangements is Respect of Health and Safety Protection, HSEPO2008(SP001). Working with Biological Agents, Guidance Notes, MRC, SPR HSEPO Page 12 of 20

13 APPENDIX B - BIOLOGICAL AGENT RISK ASSESSMENT (LABORATORY) PROCEDURE Biological Agent Risk Assessment form completed by Project or Laboratory supervisor, advice given by Biological Safety Supervisor. Risk requires CL1 or CL2 facilities. Regulatory authorities do not need notifying. Risk requires CL3 facilities or work with HSE specified HG2 agent. Regulatory authorities require notifying. Risk signed by supervisor, BSS and Head of Department. Risk sent to Biological Agents Safety Committee or equivalent and College Biological Safety Officer for discussion. Risk approved by BA Safety Committee. Risk signed by supervisor, BSS and Head of Department. Risk not approved by BA Safety Committee. Comments with improvements sent to Project of Laboratory supervisor. Original risk kept by School Safety managers, copies kept by Project or Laboratory supervisors. On receipt of signatures, enforcing authorities notified by College Biological Safety Officer. Acknowledgement from authorities waited for. Original risk kept by School Safety managers, copies kept by Project or Laboratory supervisors and College Biological Safety Officer. Assessments reviewed triennially or when significant changes to projects are made. SPR HSEPO Page 13 of 20

14 APPENDIX C CONTAINMENT LABORATORY FACILITIES This appendix provides the minimum standards for containment laboratories modified from COSHH requirements and is for information purposes only. College requirements are for laboratories to be designed to a minimum of CL2 with the addition of impervious floors to ensure consistency across the College. Table 1: Requirements for equipment and design for laboratories at different containment levels Containment measures Containment Levels (information only) Laboratory suite: No No Yes Yes isolation Laboratory: sealable for No No Yes Yes fumigation Equipment Surfaces impervious to Bench only Bench only Bench and floor Bench, floor, water, resistant to acids, ceiling and walls alkalis, solvents, disinfectants and decontamination agents and easy to clean Entry to lab via airlock No No to Yes extent risk shows it is Room negative air No to Yes Yes pressure extent risk shows it is HEPA filtered airflow No No Extract air Input and extract air Microbiological safety No to Yes, plus all Class III cabinet cabinet / enclosure extent risk procedures with shows infective materials it is to be contained within a cabinet / enclosure Autoclave Required on site Required in the building System of Work Access restricted to authorised personnel only Control measures for aerosols Required in the laboratory suite Double ended autoclave in laboratory No Yes Yes Yes (via airlock key procedure) No Required so as to minimise Required so as to prevent Shower No No Required where and shows it is Protective Clothing Suitable protective Suitable protective Suitable protective (including eye protection) clothing, clothing, clothing, minimum of lab minimum of lab minimum of lab coat coat., eye coat; footwear and protection where eye protection risk where and shows it is Required so as to prevent Required Complete change of clothing and footwear before entry and exit HSEPO2009(SPR003) Issue 1 Page 14 of 20

15 Table 1 continued: Requirements for equipment and design for laboratories at different containment levels Containment measures Containment Levels (information only) System of Work (continued) Gloves No to Yes Yes extent risk shows it is Efficient control of to Yes Yes Yes disease vectors (e.g. extent risk rodents and insects) shows which could disseminate it is BAs Specified disinfection to Yes Yes Yes procedures in place extent risk shows it is Waste Inactivation of BAs in No No to Yes effluent from handwashing sinks, and showers and similar effluents Inactivation of BAs in contaminated material and waste Other Measures Laboratory to contain its own equipment Provision of observation windows or alternatives Safe storage of BAs Written records of staff training Yes, by validated means Yes, by validated means extent risk shows it is Yes, by validated means, with waste inactivated in the laboratory suite No No Yes, so far as is reasonably practicable to to Yes extent risk shows it is to extent risk shows it is No extent risk shows it is Yes, by validated means, with waste inactivated within laboratory Yes Yes Yes Yes Yes to extent risk shows it is Note that there are no Containment Level 4 facilities at King s and details are provided for information purposes only. Yes Yes HSEPO2009(SPR003) Issue 1 Page 15 of 20

16 Table 2: Requirements for equipment and design for activities with animals involving BAs Containment Containment Levels measures Isolation of animal unit Animal facilities separated by lockable doors Animal facilities (cages, etc.) designed to facilitate decontamination (waterproof and easily washable material) Floors and / or walls and ceiling easily washable Appropriate filters on isolators or isolated rooms Incinerator for the disposal of animal carcasses Appropriate barriers at the room exit, and at drains or ventilation duct work Animals kept in appropriate containment facilities such as cages, pens or tanks but not isolators Animals kept in isolators Other measures (From Table 1) (information only) No Required to be accessible Additional / Modification Yes Yes Yes Modification Yes Yes Yes Additional Yes Yes Additional Floor Floor and walls Floor, walls and ceiling Required to be accessible Modification Yes Yes Additional Required to be accessible Required to be on site Additional Yes Yes Yes Yes Additional Other measures at Containment Level 1 Other measures Containment Level 2 at Additional Yes Yes Additional Other measures at Containment Level 3 Other measures at Containment Level 4 Note that there are no Containment Level 4 facilities at King s and details are provided for information purposes only. The right hand column states whether the particular requirements are additional to or modifications of the requirements for laboratories at each Containment Level. HSEPO2009(SPR003) Issue 1 Page 16 of 20

17 APPENDIX D KING S COLLEGE LONDON STANDARDS FOR CONTAINMENT LABORATORY EQUIPMENT The information provided in this appendix is the standards expected by the College. It may be appropriate to deviate from these standards provided equivalent results are achieved. The reasoning behind the deviation must be recorded in risk s of the work conducted within the area and be made available during safety audits and inspections. D.1 CONTAINMENT LABORATORIES D.1.1 D.1.2 D.1.3 D.1.4 D.1.5 It is College policy, as given in this Safety Procedure, that all new biological laboratories are to be designed to CL2 standards to ensure best practice. Additionally, work and floor surfaces must be impermeable to liquids. Hand washing facilities should be located near to the entrance to the laboratory. It is preferable for the taps to be operated without using hand contact, i.e. either pedal or elbow operated taps. Primary human tissue must only be handled in an unfixed state at a minimum of CL2. If agents requiring CL3 are known to be present the tissue must only be handled in an unfixed state at CL3. CL2 laboratories should have a net inward airflow if mechanically ventilated. CL3 laboratories must be sealable and have written Standard Operating Procedures for fumigation. D.2 MICROBIOLOGICAL SAFETY CABINETS D.2.1 D.2.2 D.2.3 D.2.4 D.2.5 Three types of MSCs exist. All rely on air currents and High Efficiency Particulate Absorption (HEPA) filters to remove contaminants and maintain containment. Class I cabinets have a front opening designed to protect the operator by continuously drawing air into the front of the cabinet. The air is filtered prior to exhausting. Class II cabinets have a front opening designed to protect the operator from exposure and the work from external contaminants. Inward air is directed down through a grill in front of the work area and is filtered prior to re-direction down onto the work area which together with the incoming air provides an air curtain to provide operator protection. The air not re-circulated within the cabinet is double HEPA filtered prior to exhaust. Class III cabinets are totally enclosed and draw air in through a HEPA filter at the side or back of the cabinet and is filtered prior to exhaust. Both operator and work are protected. Cabinet selection will be dependent on the work carried out and the need to limit operator exposure and for work sterility. It is not dictated by the CL the work is to be conducted at. Newly purchased cabinets must be provided with a manufacturer s or supplier s test certificate demonstrating type compliance with BS EN 12469:2000. Suppliers must inspect the proposed location for the cabinet and confirm it is appropriate prior to purchase. MSCs must be subject to examination and testing at regular intervals to comply with COSHH regulation 9 and to ensure continued safe operation: Installation: MSCs must be tested in situ to confirm the performance post installation. These tests should include demonstration of meeting the BS requirements for airflow and operator protection and the demonstration of filter integrity, both of the filter itself and of the filter housing. Daily or when used: Air flows should be checked daily or before work commences when the MSC is used. This is performed using the airflow meter incorporated into the MSC that may be in the form of a needle indicator or digital display and is often accompanied by an audible alarm that sounds before the airflow stabilises. Monthly testing: face velocity (air flow into the MSC) must be tested using a vane anemometer held perpendicularly to the opening at the four corners of the front opening. The results must be recorded and should lie within a mean airflow of 0.7 to SPR HSEPO Page 17 of 20

18 D.2.6 D m/s for Class I MSCs and not less than 0.4 m/s for Class II MSCs with a variance of less than 20%. Downflow in Class II MSCs is expected to be between 0.25 and 0.5 m/s to maintain containment and sterility. These readings may be repeated on a more regular basis as by local rules. For MSCs that are infrequently used, the daily and monthly testing may be performed only when those MSCs are to be used. 6 monthly testing: Air flow, operator protection, filter integrity and mechanical testing must be performed by a service contractor every six months in CL3 laboratories, but it is recommended that these are also performed in lower CL laboratories. Annual testing: Air flow, operator protection, filter and mechanical integrity, including visible ductwork, and electrical testing must be performed annually for MSCs in all CL laboratories. If at any point a MSC fails to meet the standards it must be taken out of usage until it can be repaired. Cleaning and fumigation: Pre- and post- use: Suitable disinfectants must be used to wipe clean all surfaces of the MSCs before and after every use. Pre-servicing: If work with HG2 or HG3 BAs is carried out the MSCs must be fumigated prior to servicing. The MSC must taken out of use until serviced and certificates confirming fumigation must be attached. Fumigation may be performed using formaldehyde or validated alternative methods. After fumigation, used MSC High Efficiency Particulate Air (HEPA) filters must either be placed in yellow bags with black stripe ( Tiger bags ) for final destruction in deep land fill or yellow biohazard bags if incineration is available. The options for disposal must be discussed with an appropriate licensed waste contractor prior to disposal. Training of personnel: Only suitably trained personnel are permitted to work in MSCs unsupervised. Training must only be carried out by those with experience of the particular type of MSC being used. Fumigation must only be performed by suitably trained personnel. D.3 AUTOCLAVES D.3.1 Normal recommended autoclaving temperatures for typical loads are as in the table below: D.3.2 D.3.3 D.3.4 D.3.5 D.3.6 Normal recommended autoclave conditions Process Sterilising temperature (range C) Sterilisation time (minutes) Liquid sterilisation Equipment / glassware sterilisation Make-safe cycles (decontamination of materials for discard or for re-use) It may be appropriate for alternative conditions to be employed to ensure complete destruction within the chamber. Advice from the competent person performing autoclave servicing is if this is the case. Autoclaves must have their door locks and seals visually examined weekly and any leak attended to as soon as possible. A written record of these examinations must be kept. All autoclaves must be serviced by a competent person according to a written scheme. Typically this will mean a six-monthly service. Pressure and insurance examinations must be performed as by the Pressure Systems Safety Regulations, Only suitably trained personnel are permitted to operate an autoclave. Records of training must be kept to demonstrate competence. It is in CL3 laboratories that records of autoclave runs are kept. The original records must be retained until the date of the next functional testing. HSEPO2009(SPR003) Issue 1 Page 18 of 20

19 D.3.7 All laboratories handling animal pathogens listed under SAPO must keep records of autoclave runs. The original records of autoclave runs must be retained until the date of the next functional testing. D.4 DISINFECTION AND WASTE DISPOSAL D.4.1 D.4.2 D.4.3 D.4.4 D.4.5 D.4.6 D.4.7 All BA waste must be inactivated before leaving the College. Liquid waste must have an appropriate disinfectant added for the contact time. The disinfectant must be prepared according to manufacturer s instructions to achieve a final concentration as given by the manufacturer. Used solid media must be placed in clear autoclave bags and autoclaved. Hard waste that has been in contact with biological agents such as disposable plasticware should be disinfected using an appropriate disinfectant used according to manufacturer s instructions for the contact time. For HG1 and HG2 BA waste, surfaces in contact with the BA require disinfection. Dependent on the BARA it may be appropriate for solid BA waste to be autoclaved instead of treated chemical disinfection. All solid waste must be placed in either yellow or orange biohazard bags when being sent for final destruction. All solid waste must be collected and taken for final destruction, preferably by incineration, by an appropriately licensed waste contractor. D.5 CENTRIFUGES D.5.1 D.5.2 D.5.3 D.5.4 D.5.5 A clear area of 300 mm should, where practicable, be kept around centrifuges or the operator must remain outside of this distance in the event of the centrifuge moving as a consequence of a disruption. Centrifuges should be cleaned and / or disinfected at the end of each working day and after any breakage. Centrifuges must be decontaminated prior to maintenance work and a signed certificate stating this attached. Safety inspections must be performed annually. It is recommended that servicing also be performed annually. Personnel must be trained in the use of centrifuges by those with experience of the models being used. Training should be recorded. D.6 PERSONAL PROTECTIVE EQUIPMENT D.6.1 D.6.2 D.6.3 D.6.4 Laboratory coats must be worn in all laboratories handling biological agents. In CL2 and CL3 laboratories these must be side or back fastening with elasticated cuffs, it is recommended that this design be used at CL1. Gloves must be of the appropriate material to provide adequate protection and conform to European Standard EN 374. Note that latex gloves, if used, must be low protein and powderfree. Eye protection must be suitable for the activity and the type of protection will be determined by risk. When full face visors are used, they must be impact resistant and conform to British Standard BS EN 166A. Respiratory protective equipment (RPE) is subject to requirements of the COSHH regulations and selection and use of RPE will be determined by risk. If RPE is necessary it must be individually face-fitted to ensure proper functioning. Users must be instructed in the use of RPE and records retained. HSEPO2009(SPR003) Issue 1 Page 19 of 20

20 D.7 TRAINING RECORDS D.7.1 D.7.2 D.7.3 D.7.4 Training records are for personnel involved in activities with HG3 BAs. Personnel working with HG1 and HG2 BAs are also to have training records. This does not apply to taught students in practical classes. Training records must record the date of training, what the training is in, the trainer s signature and the trainee signing that they are confident that they have been trained adequately. It is good practice for trainees to be competency assessed by trainers and for this to be recorded in the training records, e.g. Needs supervision; Can work without supervision; Can work without supervision and can train others. It is recommended that all personnel working with BAs attend HSEPO Biological Safety Training Module 1: Biological Laboratory Safety and Microbiological Safety cabinets. D.8 SPILLAGE KITS D.8.1 D.8.2 Spillage kits must be readily accessible in all laboratories working with BAs. Spillage kits must contain a minimum of: Haz-Tab absorbent granules or equivalent disinfectant Haz-Tabs or equivalent disinfectant A container to make the disinfectant in Absorbent towels Plastic scoops Biohazard plastic bags Forceps Low protein, powder-free latex or powder-free nitrile gloves Accident procedure instructions / Standard Operating Procedure Note that the disinfectant used should be checked as being effective on the BAs being used in the laboratories by either local validation or by information from the manufacturer. Additional components may include all or some of the following dependent on local procedures and the hazards posed by the BAs encountered: Biohazard warning tape for marking off the spillage area Disposable plastic aprons Disposable overshoes Warning notices and / or Biohazard spill signs Face masks D.8.3 D.8.4 Spillage kits must be regularly checked and contents replaced when date expired. Everything used during spillage clean-up must be discarded into biohazard plastic bags for disposal through normal channels. D.9 AUDITING AND MONITORING D.9.1 D.9.2 D.9.3 Containment Level 3 laboratories will be audited annually by the College Biological Safety Officer of HSEPO to ensure standards are being maintained and others will be audited on the basis of risk s. All laboratories must be subject to a local inspection regime with a record of the outcome and any necessary remedial measures submitted to the relevant School Safety Committee. Conditions within the laboratories are expected to be monitored on a more frequent basis by Laboratory Supervisors to ensure that standards are maintained. All laboratories are expected to maintain central, accessible files of Standard Operating Procedures, Codes of Practices, Laboratory Rules or equivalent. These should be available to all personnel within the laboratories. HSEPO2009(SPR003) Issue 1 Page 20 of 20