FACULTY OF HEALTH AND MEDICAL SCIENCES HEALTH AND SAFETY PROCEDURES PART 3 BIOSAFETY AND BIOSECURITY

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1 FACULTY OF HEALTH AND MEDICAL SCIENCES HEALTH AND SAFETY PROCEDURES PART 3 BIOSAFETY AND BIOSECURITY 1.0 Introduction to Biological Agents in the Faculty A wide and ever expanding range of biological materials is handled within the Faculty of Health and Medical Sciences and include: 1. Micro organisms such as bacteria, viruses and fungi, either in pure culture or contained in natural materials such as water, soil or plant material, clinical specimens or sewage, etc. 2. Whole experimental animals or specimens from these. 3. Human material in the form of blood or other body fluids, soft tissue samples or bone explants. 4. Human, animal or plant cells in culture, including both primary cells and established cell lines. 5. Genetically modified organisms (GMOs). This includes not only the act of genetic modification, but also any use of a GMO brought into the Faculty form outside. The use of GMOs is covered by separate legislation and is the subject of specific Faculty guidelines. The hazards of these materials may be: a) The material is itself infective. Many of the microorganisms handled in the Faculty are potentially pathogenic to humans. b) The material may be the vehicle for a potentially infective agent. Unscreened human specimens may contain pathogens such as Hepatitis B virus or HIV, animal material may convey diseases such as Salmonellosis or Weil's disease, while environmental or food samples can contain pathogens such as Clostridium botulinum or Listeria monocytogenes. Primary cell cultures may carry latent viruses. c) The material may acquire infectivity by contamination. Sterile blood or serum may be contaminated by experimental or environmental organisms if it is not properly handled. Similarly, cell lines may be contaminated by potentially hazardous adventitious agents. The first line of defence is to follow Good Microbiological Practice, that is to say the acquisition of good laboratory habits; careful and efficient technique; proper and prompt cleansing of apparatus and/or disposal of materials after use; and attention to personal and general hygiene. 1

2 A research worker handling biological material has a responsibility to others. Accident investigations show that whilst laboratory workers may protect themselves they frequently show a lack of thought for the consequences to washers-up, cleaners, porters, etc., whose job is to deal with the by-products of their work. Although these guidelines concentrate on the risk of human infection, your risk assessment should also consider potential environmental hazards. This is especially important for any work with GMOs. As well as an invective hazard, some biological materials may also be radioactive or have carcinogenic activity. Due consideration should therefore be given to all contributors to the level of risk and the proper storage, use and disposal requirements met. Consult the Biological Safety Officer or your Radiation Protection Supervisor to establish these procedures before commencing this kind of work. 2. Categorisation of Pathogens according to Hazard/Categories of Containment 2.1 Hazard groups/handling of cultures/biological materials in each hazard group All microorganisms are allocated to one of four categories on the basis of their inherent hazard. The corresponding levels of containment are intended to compensate for the microbiological risks encountered when handling pathogens in the various hazard groups. The risk assessment for biological materials involves an assessment of the likelihood of the material containing pathogens in these categories. Organisms are not fixed in their hazard groups; as new information becomes available they may be moved up or down. ALL micro-organisms and biological materials should be treated with respect as potential pathogens or vehicles for pathogens and the general precautions followed at all times. GROUP 1 GROUP 2 An organism that is most unlikely to cause human disease. These organisms must not be assumed to be non-pathogenic and the general precautions must always be followed. Faculty policy is to handle these organisms as Group 2. An organism that may cause human disease and which might be a hazard to laboratory workers but is unlikely to spread to the community. Laboratory exposure rarely produces infection and effective prophylaxis or effective treatment is usually available. Many commonly used HG2 organisms are potentially pathogenic. Cultures should not be introduced into a practical class unless the lecturer is satisfied as to the competence of the students to handle them. GROUP 3 An organism that may cause severe human disease and presents a serious hazard to laboratory workers. It may present a risk of spread to the community but there is usually effective prophylaxis or treatment available. 2

3 These organisms may only be handled at containment level 3, in the Restricted Laboratory (29 AX 02). Normally only experienced staff and postgraduate students shall handle them. Final year students may be allowed to do so but only if directly supervised by, and in the presence of, a member of the academic staff. Detailed written protocols must be provided for all proposed work in these laboratories and prior written approval from the Faculty Safety Committee is required before bringing Hazard Group 3 organisms, or materials containing, them into the Faculty. GROUP 4 An organism that causes severe human disease and is a serious hazard to laboratory workers. It may present a high risk of spread to the community and there is usually no effective prophylaxis or treatment. The introduction, handling or storage of any material containing live Group 4 organisms into the Faculty is prohibited. 3. Guidelines for the Handling of Biological Specimens 1. All biological material (cultures, specimens, human materials) is to be categorised as belonging to Hazard Group 2 and handled with appropriate precautions in Containment Level 2 facilities unless assessment indicates that it should be placed in Hazard Group 3. All biological laboratories within the Faculty (except 29 AX 02) are Containment Level 2 facilities. Your risk assessment should include a check that the laboratory concerned is approved for the handling of biological material. 2. The Faculty Safety Adviser and the Biosafety Adviser must be informed before bringing any new microorganism into the Faculty, as regulatory procedures from the HSE may need to be followed to keep us legal. The Biosafety Adviser should be consulted before working with unfamiliar materials or bringing them into the Faculty. Many biological materials are subject to separate statutory controls as animal or plant pathogens. 3. No work with Hazard Group 3 cultures or specimens may proceed before permission is granted by the Faculty Safety Committee and no Group 3 material may be brought into the Faculty before that permission is granted. If there is reason to believe that Group 3 organisms are present in material introduced to the Faculty as Group 2 all work with this material must stop at once and the material be either transferred to the Containment Level 3 laboratory or destroyed by autoclaving. 4. All work with GMOs, whether modified in house or acquired from external sources, must be approved by the Faculty Safety Committee before work starts. 3.1 Containment Level 2 Containment level 2 is suitable for work with pathogens in Hazard Group 2 and with biological materials which contain, or could contain, such organisms. Laboratory personnel must receive instruction and training, 3

4 and an appropriate standard of supervision of the work must be maintained. The requirements for a CL2 laboratory are laid down by the HSE ( The management, design and operation of microbiological containment laboratories ). 1. Access to the laboratory should be limited to laboratory personnel and other specified persons. 2. General tidiness and cleanliness is essential, benches should be kept as clear and clean as is practicable and there must be sufficient bench space to ensure safe working procedures. Books and papers must be kept separate from areas where biological materials are being handled. 3. The laboratory door should be closed when work is in progress. 4. Laboratory coats must be worn in the laboratory and removed when leaving the laboratory suite. 5. Eating, chewing, drinking, smoking, storing of food and applying cosmetics must not take place in the laboratory. Mouth pipetting must not take place. 6. Hands must be disinfected or washed immediately when contamination is suspected, after handling infective materials, and also before leaving the laboratory. 7. In general, work may be conducted on the open bench, but care must be taken to minimise the production of aerosols. For manipulations likely to give rise to aerosols (vigorous shaking or mixing and ultrasonic disruption, etc.), or any work with pathogens which are known to be transmitted by the airborne route, a microbiological safety cabinet or other suitable containment must be used. The cabinet must exhaust to the outside air or to the laboratory air extract system after filtration e.g. a Class 2 design). 8. Sealed buckets must be used for the centrifugation of all Hazard Group 2 microorganisms and any material which might contain them.. 9. Effective disinfectants must be available for routine disinfection and immediate use in the event of spillage. If infectious material is spilt during a practical class the academic in charge must be informed immediately. 10. Bench tops must be disinfected after use and routinely at the end of each working day by being wiped down with an appropriate disinfectant. 'Benchcote' may be used as an additional precaution but must never be seen as a substitute for a clean, clear bench. It should be changed frequently and the underlying bench decontaminated. 4

5 11. All waste material, and potentially contaminated glassware or other equipment, must be made safe before disposal or re-use. 12. All accidents and incidents must be immediately reported to and recorded by the person responsible for the work. 3.2 Transport of specimens and cultures 1. Cultures and specimens leaving the Faculty must be properly packed so that in normal circumstances there is no chance of spills or leaks. 2. Special, Biohazard-labeled transport containers must be used for transport of clinical specimens and cultures of organisms outside the Faculty (e.g. to and from Manor Farm or the Royal Surrey County Hospital. 3. Shipping of cultures or biological materials out of the Faculty must comply with all national and international regulations. The preferred shipper, Danvers International, can advise on all aspects of packing and posting biological materials and also maintains stocks of approved packing materials. Please see Rita Dunford in AX Reception for details. 4. Material transported between buildings must be suitably packed. 3.3 Treatment of infected material 1. All solid waste material from microbiology laboratories (except waste paper) and all infected or potentially infected liquid waste must be effectively autoclaved before disposal. 2. All infected and potentially infected glassware and other equipment to be reused must be autoclaved before being washed. If the equipment cannot be autoclaved the SSA should be consulted before alternative methods are used. 3. "Sharps" such as needles and scalpel blades (whether microbiologically contaminated or not) must be placed in the special yellow plastic sharps bins, which will be autoclaved and then incinerated. 4. Only trained members of staff may operate autoclaves. The autoclaves are serviced at regular intervals by qualified, competent engineers. No member of the Faculty may carry out any servicing procedure or alter the fixed controls. 5. The use of disinfectants must comply with the Faculty disinfection policy. The policy can be obtained from the Faculty Safety Adviser in 33AY03. DISINFECTION IS NOT A SUBSTITUTE FOR AUTOCLAVING. Where new disinfectants or procedures are considered necessary the Biosafety Adviser, Dr Graham Stewart, must be consulted 5

6 beforehand. The Biosafety Adviser must have approved the protocols for the dilution and use of the disinfectant and be satisfied with its effectiveness against the material in question, before work commences. 6. This section does not necessarily apply to innocuous natural material such as water, soil and plant material but users must consider any potential hazards arising from such items. Discretion must be exercised in each case and the Biosafety Adviser, Dr Stewart, must be consulted if there is any doubt as to the correct action. 7. Items of equipment must be decontaminated before repair or maintenance (and always before removal to the Faculty workshop), whether repairs are carried out by the Faculty staff or an outside contractor. If decontamination is impossible the Biosafety Adviser must be consulted before any work is carried out, so that safe working procedures can be implemented. 3.4 Breakage and Spillage Procedure 1. All breakage of glassware or apparatus containing infectious material, or spillage of infectious material in teaching laboratories must be reported immediately to the academic in charge, who will initiate decontamination procedures. Breakages and spillages elsewhere should be dealt with by the nearest competent member of staff. If there is any doubt about the identity of the spilt material the area should be cleared as a precaution and specialist advice obtained. 2. If it is thought that breakage or spillage has occurred in a centrifuge the machine should remain unopened until a competent person has been consulted as to suitable decontamination procedures. 4. Procedure to be followed Gloves must be worn. Broken glass must not be handled directly, always use forceps or a dustpan. Wear a respirator if harmful aerosols are likely. Disinfectants need adequate contact time to work efficiently. Spills and contaminated surfaces should be left in contact with liquid disinfectant for up to 10 minutes. Simple(non-violent) spillages, not involving broken glass, should be dealt with by covering the material with paper towels or cloths and saturating it with a suitable disinfectant (usually Virkon) Always use correctly prepared disinfectants on spillages. Rubber gloves should be worn for the collection of used paper towels and cloths, which should be put into a container for autoclaving. The surface and gloves should be wiped over with fresh disinfectant. 6

7 Spillages of cultures involving broken glass. Apply a suitable disinfectant to the spillage. Wearing heavy-duty (non-disposable) rubber gloves sweep up broken glass and disinfectant with a dustpan and brush, using forceps or tongs to handle larger pieces. Put the broken glass and disinfectant into a disposable plastic waste jar (large broken glass items can be placed into a special grey box, marked in red 'broken glass'). The contaminated broken glass must be autoclaved. Put the dustpan and brush into an ordinary grey box of disinfectant. Wipe up residual disinfectant with a disposable cloth or tissues and place the cloth/tissues into the disposable plastic waste jar. Swab floor and gloves with fresh disinfectant and wipe dry with cloth or paper towels. Place all used cloths/towels into the disposable plastic waste jar before removing gloves. Major breakages with widely scattered debris and large amounts of aerosol formation require the evacuation of the area for about 30 mins to allow aerosols to settle. After 30 mins a competent person wearing appropriate protective clothing (including a respirator if necessary) may enter and deal with the spillage as set down above. If an individual has been contaminated by spilt culture all items of contaminated clothing must be removed and autoclaved, or soaked in disinfectant. If appropriate the Occupational Health Service or Student Health Service should be consulted as soon as possible. 4. Use of Human materials 4.1 University Policy on the Use of Human Specimens Anyone using any human material for general teaching or research in the Faculty must follow the he University of Surrey Code of Practice for Work with Human Blood products and other tissue specimens. SOPs such as those in the SCRS and the CIU may apply as well. The main objective of this policy is to minimise the risk of infection by blood borne viruses. Even when this policy is applied, a COSHH assessment must also be carried out for all work involving the use of human material. Screened specimens shown to be free of both HBV and HIV may be handled at containment level I. Unscreened specimens from non-high-risk group subjects must be handled at containment level 2. Unscreened specimens from high risk groups, and specimens from subjects with HBV and/or HIV infections, are classed in Hazard Group 3 and must not be brought into the Faculty without prior approval from the Faculty Safety Committee and the University Safety Committee. These specimens must only be handled at containment level 3 by trained workers. 7

8 4.2 Blood collection Blood specimens may only be taken by authorised persons who have been trained, and have been approved by a medical practitioner appointed for this purpose by the Faculty. Currently this is Dr Wright. 5.0 Genetic Modification and GMOs 5.1 Definition of a genetically-modified organism (GMO). Genetic modification means altering the genetic material or transferring genetic material by a way that does not occur naturally (by mating or natural recombination or both). This definition applies to any organism whether these are plants, animals or micro-organisms (e.g. bacteria, viruses, fungi, protozoa, animal or plant cell cultures). It is important to note that the use of GMOs which have been generated elsewhere is subject to this regulation, even if there is no intention to carry out any further genetic modification. 5.2 Registration Anyone wishing to carry out any work with GM organisms must first register with the Faculty Biological & Genetic Modification Safety Advisor. This is a legal requirement. No new work involving the use or generation of Genetically Modified Organisms (GMOs) may be carried out by any person in the Faculty until a risk assessment has been approved by the Faculty Safety Committee. There is a separate document of guidance on GMOs and risk assessment please contact the Faculty Safety Adviser. Remember, no genetically modified organism may be brought into the Faculty without the prior approval of the Faculty Safety committee. Safety Procedures Part 3 TA rev 2004 NC rev