Biological Safety Program. For. Otterbein University

Transcription

1 Biological Safety Program For Otterbein University Developed in conformance with the Ohio EPA Infectious Waste Regulation, OAC

2 Table of Contents PURPOSE... 2 GENERAL STATEMENT... 2 POLICY... 3 BIOLOGICAL RISK ASSESSMENT... 3 PROHIBITED ACTIVITES... 4 TRAINING... 4 STANDARD MICROBIOLOGICAL PRACTICES... 4 EXPERIMENTAL ANIMAL WORK... 6 LABELING REQUIREMENTS... 6 BIOLOGICAL EMERGENCIES AND SPILLS... 6 SPILLS... 6 SKIN, EYE AND OTHER EXPOSURES... 7 BIOLOGICAL WASTE HANDLING AND DISPOSAL... 7 NON-REGULATED WASTE (EXCLUSIONS)... 9 RESPONSIBILITIES

3 Biological Safety Program Section: CHEMICAL HYGIENE Effective: APRIL 1, 2013 Applies to: ADMINISTRATORS, FACULTY AND STAFF Responsible Division/Department OFFICE OF BUSINESS AFFAIRS PURPOSE The purpose of this program is to establish guidelines for the safe operation and performance of laboratory experiments involving potentially hazardous biological agents. It also provides guidance for procedures to properly handle all regulated medical waste according to Ohio s infectious waste regulations for small quantity generators. GENERAL STATEMENT The Biosafety Program at Otterbein University was established to promote safety in biological research, to ensure the safe handling of all biological agents, to ensure the proper handling of infectious waste and to prevent opportunities of infection to all faculty, staff and students. This program also provides guidelines to maintain compliance with Ohio Administrative Code and regulations for infectious waste. This program applies to all faculty, staff and students with potential exposure to biological agents. The term biological agents is defined as any agent of biological origin that has the capacity to produce detrimental effects on humans, animals, plants, and/or the environment. The following are considered biological agents under this program: 1. Infectious organisms such as bacteria, viruses, fungi, parasites, and prions. 2. Harmful metabolic products from organisms, such as exotoxins or mycotoxins 3. Recombinant DNA molecules 4. Infectious materials from animals or plants, such as tissues and cell cultures 5. Invertebrate vectors of human diseases 6. Zoonotic diseases from research involving animals Human Blood or other potentially infectious materials (OPIM) are defined in Otterbein s Bloodborne Pathogen s Exposure Control Plan. 2

4 POLICY Biological Risk Assessment: Criteria for defining levels of containment. (Risk Groups & Biosafety Levels) Biological agents are classified into Risk Groups by the Center for Disease Control (CDC). This classification can be found in the CDC Biosafety in Microbiological and Biomedical Laboratories 5 th Edition, 2009 (BMBL). The CDC also has defined a set of specific laboratory practices or Biosafety Levels for each risk group. These biosafety levels also can be found in the BMBL. The Risk Groups indicate the likelihood of organisms to cause a human disease, and the biosafety level indicates the type of facilities, and personal protective equipment that would be appropriate to contain and safely work with the organism. All experiments involving the use of infectious material are expected to be performed under containment conditions which will minimize the possibility of exposure to anyone within or outside of the laboratory. In order to ensure proper containment, Otterbein follows the recommended guidelines of the CDC. The following table gives and overview of the CDC s recommended Biosafety Levels Biosafety Level Agent Practice Primary Barrier and Safety Equipment 1 Not known to Standard None required consistently cause Microbiological disease in healthy Practices humans (RG1) 2 Agents associated with human disease (RG2) 3 Exotic agents with potential for aerosol transmission Disease may have serious lethal consequences (RG3) 4 Dangerous exotic agents which pose high risk of life threatening disease Aerosol transmitted laboratory infections have occurred or related agents with unknown risk of transmission (RG4) BSL-1 practices plus: limited access and biohazard warning signs, sharps precautions, and a biosafety manual defining proper procedures BSL-2 practices plus: Controlled access, decontamination of all waste, decontamination of laboratory clothing before laundering Baseline serum BSL-3 practices plus: Clothing change before entering Shower on exit All material decontaminated on exit from facility Class I or II Biosafety Cabinets Physical containment devices for manipulations that may cause splashes or aerosols and lab coats, gloves and safety glasses (required with broth cultures) Class I or II BSCs or other physical containment devices used for open manipulation Protective laboratory clothing, gloves, and respiratory protection needed Primary barriers: All procedures conducted in Class III BSCs or Class I or II BSCs in combination with full body, airsupplied, positive pressure personnel suit Facilities (Secondary Barrier) Lab bench and sink required BSL-1 plus: Autoclave available BSL-2 plus: Physical separation from access corridors Self-closing double door Exhaust air not recirculated Negative airflow into laboratory BSL-3 plus: Separate building or isolated zone Dedicated supply and exhaust, vacuum and decontamination systems 3

5 Prohibited Activities: Otterbein University does not have the appropriate facilities to conduct research on some biological activities. The following types of activities are restricted from the Otterbein Campus. Training: a. Work with RG3 or RG4 biological agents, or work that would require BSL-3 or BSL-4 level containment. b. Experiments that would involve plant pathogens or vectors for which the U.S. Department of Agriculture may refuse to issue a permit. c. Experiments that would involve the use of animal pathogens that are forbidden from entry into the United States. d. Experiments involving the recombinant DNA derived from pathogenic organisms classified as risk groups 3 or 4 or from cell lines known to be infected with such agents. Awareness level training should be provided to all personnel that are at risk of exposure to any biohazard material. All research students receive awareness level training when they complete the online Laboratory Safety Course. For other areas on campus, or as needed the Chemical Hygiene Officer is available for assistance when designing and presenting training programs for individual needs or audiences. If an employee or student is expected to work directly with biohazardous material, the individual should be provided additional training by the person in charge of the laboratory in the proper handling of the biological material using standard microbial practices or specific animal handling precautions. Those persons also should have knowledge of the campus biological waste procedures. Training should be provided upon initial work assignment and refresher training should be provided as necessary. See Appendix A for guidelines on additional biosafety training. STANDARD MICROBIOLOGICAL PRACTICES Most of the organisms used in the Otterbein laboratories can be used at the BSL-1 containment level. However, we do have a few organisms that are risk group two and require BSL-2 containment. So, for the safety of all faculty, staff and students, we operate our Microbiology and Molecular Biology labs at a BSL-2 level. Standard microbiological practices must be used in these lab areas, as well as in any other lab with biohazardous agents, regardless of the risk level. Listed below are the standard required practices for all areas with biohazard agents: 1. All persons working in the lab area must wash their hands after working with potentially hazardous materials, and before leaving the lab area. 4

6 2. Eating, drinking and applying cosmetics are not permitted in these lab areas. 3. Precautions should be taken when using sharps that may be contaminated with biohazards. All needles, syringes, scalpels or other contaminated sharps should be collected in designated biohazard sharp containers. 4. Broken glass should be decontaminated using the laboratory disinfectant prior to collecting it in the broken glass containers. The lab manager or supervisor will provide a strainer to disinfect broken glass. 5. Decontaminate all cultures, stocks and other potentially infectious material prior to disposal using an effective method (see Appendices C or D). If the biohazard material needs to be moved to a different location for disposal, it needs to be transported in one of the following manners: a. To transport biohazardous materials from one laboratory to another it must be inside a durable, leak proof container, or on a cart. Only fill biohazard bags 3/4 full, and loosely close the bag, so that it does not explode inside of the campus autoclave. b. When biohazard sharps containers are ¾ full and ready for disposal, close them and notify the laboratory manager or chemical hygiene officer for collection. All biohazard sharps containers are collected for off campus disposal by the campus Chemical Hygiene Officer in accordance with applicable local, state and federal regulations. 6. Non-disposable items or glassware that may be contaminated with biohazards, should be collected in a designated biohazard area to be processed for decontamination using Otterbein s autoclave. All arrangements for autoclaving materials need to be arranged through the Biology & Earth Science Department, Laboratory Coordinator, All work surfaces need to be properly decontaminated using the laboratory disinfectant after completion of any work using potentially infectious material. 8. The person in charge of the laboratory using infectious material is responsible for ensuring that all lab personnel working in the area have knowledge of the biohazard agents and the risks associated, as well as the proper training to work with these organisms. In addition to the above practices, the following must occur if the lab is designated as a BSL-2 laboratory: 1. The laboratory should have restricted access, and the lab door should be closed when you exit the lab area. 2. The person in charge of the laboratory must ensure that the personnel working with the infectious material demonstrate proficiency in the standard microbiological practices before working with the agents. 3. Laboratory equipment and lab benches should be routinely decontaminated when work that involved the use of infectious agents has been completed. 4. Spills involving infectious materials must be contained, decontaminated and cleaned up by properly trained lab personnel, according to the Otterbein s Biosafety spill procedures and/or specific training provided by the person in charge of the laboratory. 5. All procedures involving manipulation of BSL-2 organisms must be conducted in a manner that minimizes the risk of aerosols or splashes. If there is a high risk of aerosols or splashes, the work 5

7 must be completed inside a designated Biosafety Cabinet (BSC) or other containment devices. The Biosafety Cabinets will be tested annually to help ensure adequate protection is being provided. The Chemical Hygiene Officer will monitor and maintain the scheduling of the BSCs. EXPERIMENTAL ANIMAL WORK The Institutional Animal Care and Use Committee (IACUC) must be fully informed of studies involving use of experiments that involve the use of vertebrate animals (fish, amphibians, birds, reptiles, and mammals). This committee and the person in charge of the laboratory where the research is being conducted must concur on all aspects of containment conditions and practices essential for protection of personnel and the animals being used. Research experiments involving the use of animals are not to be started until an agreement is made between the person in charge of the lab and the IACUC. Work with captive wild animals and certain domestic animals with unknown health history are to be considered potentially dangerous even if no experimental infectious or hazardous agent is being used. The animal may harbor a zoonotic disease capable of infecting humans. It is best practice to regard all questionable animals as potentially infectious. Appropriate biosafety precautions must be developed by the person in charge of the classroom, field, or research lab activity involving such animals. LABELING REQUIREMENTS All equipment, laboratories, and biohazard waste containers that may be contaminated with RG2 organisms must be clearly labeled with a universal biohazard symbol, including refrigerators or freezers where these agents are stored. The laboratories designated as BSL-2 also should have a sign posted on each entrance, indicating the biohazard level and including the name and phone number of the person responsible for the lab area. All persons with access to these work areas need to have completed and documented laboratory safety training, or have an approved laboratory visitation form. The visitor form can be obtained from the Chemical Hygiene Officer or the Administrative Assistant of the Department. BIOLOGICAL EMERGENCIES AND SPILLS Spills: Each laboratory using biological must have a procedure and equipment available to deal with spills that occur in their laboratory. There are variations that may be acceptable on procedures, but a basic outline for handling biological spills can be found in (Appendix B). Biological spill kits can be commercial specific kits, or just part of the standard lab equipment. All workers in the lab must be aware of the location of the spill kit materials. The spill kit should include the following materials: Laboratory Disinfectant 6

8 Absorbent Material (paper towels or commercial absorbents) Dust pan & Broom Gloves and Safety Glasses Biohazard Bag Forceps or other tool for handling sharps or broken glass When a biological spill occurs, notify the person in charge of the laboratory. Isolate the spill to prevent others from accessing it. Using a tool, remove all sharps or broken glass and place them in a biohazard sharps container. Then put on the proper PPE and proceed with cleanup of the biological spill, according to the spill procedure. If the biological spill occurs inside of a biological safety cabinet, (BSC) be sure to leave the cabinet turned on, then put on the proper PPE and proceed with the cleanup. After cleaning a spill inside of the BSC, spray down the walls and wipe all surfaces with the approved disinfectant. Also, check and clean the catch basin. Allow the BSC to disinfect for a minimum of 15 minutes. Skin, eye and other exposures: If there is a skin exposure, remove any contaminated clothing. Then wash the contaminated area with soap and water for 1 minute. If necessary seek medical attention. If there was a chance that the exposure was to damaged or broken skin, wash the area for a full 5 minutes and seek medical attention if necessary. If there is an eye exposure, flush the eyes with the emergency eyewash for a full 15 minutes. The victim should hold the eyelids open and rotate the eyes while the water is flowing over the eye. Seek medical attention if necessary. If there is an exposure to mucous membranes (nose, mouth), flush the exposed area for 5 minutes. Seek medical attention if necessary. If there is an ingestion or inhalation exposure, move the victim to fresh air. Call 911 for medical assistance if necessary. Do not induce vomiting unless instructed by a medical professional. Report all incidents to the person in charge of the laboratory, if emergency personnel are needed call 911. BIOLOGICAL WASTE HANDLING AND DISPOSAL All biological waste shall be considered capable of producing an infectious disease if it has, or it may have been contaminated by an organism that may be pathogenic to humans. All infectious waste must be segregated at the source of generation. Specific categories of regulated medical waste are: Cultures and stocks of microorganisms and biological that may be pathogenic to humans 7

9 Blood and blood products (See Otterbein s Blood Borne Pathogen Exposure Control Plan) Tissues and other anatomical wastes Sharps such as needles, syringes, and scalpel blades that likely are contaminated with organisms that are pathogenic to humans. Animal Carcasses, body parts, bedding and related wastes When animals are intentionally infected with organisms likely to be pathogenic to humans for the purpose of research, in vivo testing, production of biological materials or any other reason the carcasses, body parts and bedding materials are considered regulated biological waste. Regulated biological waste may not be discarded in the normal everyday trash containers. All biohazard waste should be collected in an approved biohazard waste container until proper disposal can be arranged. Infectious waste may be disposed of by three methods: removal and disposal by a contract infectious waste company, treatment with a hypochlorite solution (Appendix C) or treatment using the university autoclave (Appendix D). All sharps must be collected in a puncture proof biohazard container. The sharps containers should be closed when they reach ¾ full. When the sharps containers are ready for disposal notify the lab manager or campus Chemical Hygiene Officer ( ) to collect them for contracted off-site treatment and disposal. The collection boxes are stored in the service department, in a secured location, and they are stored and maintained in a non-putrescent state until a pick up is scheduled. Waste should be refrigerated if necessary. The university maintains a contract with a state licensed infectious waste service company to pick up, transport, treat, and dispose of regulated medical waste. All contracted biological waste manifests will be maintained by the campus Chemical Hygiene Officer. All preserved animal carcasses should be collected in double bagged heavy duty trash bags. These bags should not exceed 20 lbs., to ensure that the individual transporting them for disposal can lift them on their own, and to help prevent the bags from ripping. The bagged preserved animal waste should be stored in the designated trash containers inside the walk-in refrigerator of room 140 in the Science Center. When the animal waste is ready for disposal, notify the campus Chemical Hygiene Officer. If the animal waste has not been preserved, it should be double bagged and stored inside a designated laboratory freezer, until arrangements for proper disposal have been arranged with the campus Chemical Hygiene Officer at All other biological waste should be collected in biohazard waste bags, and should only be filled 3/4 full to ensure adequate steam penetration during autoclaving. This also prevents the bag from erupting inside the chamber of the autoclave during the sterilization process. 8

10 NON-REGULATED WASTE (EXCLUSIONS) The following wastes are not subject to the requirements of this program: Animal bedding that is not considered to be infectious can be bagged and collected for disposal in the normal waste bin, as long as the area is maintained in a sanitary fashion for facility staff. The animal bedding collected at the Equine Facility will be composted using a reputable service provider. Regulated medical waste that has been treated by autoclaving. Normal everyday trash, such as laboratory paper towels and gloves that are not grossly contaminated with hazardous materials Spoiled Meat or other food items being discarded because of spoilage or contamination Used personal hygiene products such as facial tissues, and sanitary napkins Material, not including sharps containing small amounts of blood or body fluids, such as a bandage RESPONSIBILITIES The Chemical Hygiene Officer (CHO) will assist with implementation of this program, and help facilitate safe practices and procedures when using biological agents in Otterbein laboratories. The CHO will also maintain all contracted regulated medical waste removal records. The Institutional Review Board (IRB) is responsible for monitoring and oversight of all behavioral research that involves the use of human subjects when the human subjects themselves are the source of data. For information on this process go to _research/srf_forms.aspx The Institutional Animal Use and Care Committee (IACUC) is responsible for monitoring and oversight on all research experiments that may involve the use of vertebrate animals (fish, amphibians, birds, reptiles, and mammals). For information on this process see the Animal Use and Care form on _research/srf_forms.aspx The Faculty or Staff in charge of the laboratory is responsible for following all procedures described in this program, in addition to monitoring the day to day operation of the lab area, and to take all necessary steps, including proper training, for the protection of staff and students working with biological materials. The faculty is also responsible for ensuring that all research projects that involve animals or humans are reviewed by the appropriate institutional committee (IACUC or IRB) and approved prior to starting the research. 9

11 All Laboratory Workers (Faculty, Staff and Students) are required to follow the procedures listed in this program as well as specific procedures provided in each individual laboratory working with biological agents. 10

12 Appendix A Guidelines for Biosafety Information 1. Cover the specific biohazard agents used in the lab, and the risk groups associated with them. Include any special containment of handling practices beyond the standard microbial practices. 2. Cover Routine Procedures: Where the biohazard waste or sharps container is located if applicable. Where is the procedure for routine decontamination off surfaces located. Are any vaccinations available for using the biological agent. Where can lab specific procedures that may differ from the Biosafety Manual be located. Where can information about personal protective equipment for this lab be found. 3. Review approved biological waste procedures used in this particular laboratory. Treatment using sodium hypochlorite solution autoclave 4. Review all spill supplies and their location within the lab. Absorbents Disinfectant Biohazard bags Gloves Safety glasses or other required PPE First aid kit Location of written biological spill procedures 5. Location of nearest emergency shower and eyewash 11

13 Appendix B Handling Biological Spills 1. Restrict access or isolate area of the biological spill. 2. Obtain the disinfection solution a. 10% Household bleach in water (10% by volume) b. Other approved disinfectant prepared according to manufacturer instructions 3. Get personal protective equipment (PPE) and spill clean-up supplies. a. protective gloves and safety glasses 4. Use tongs or other tools to remove any sharps, broken glass, etc. from the spill. Place the sharps into a sharps container. A spaghetti strainer can be used to disinfect broken glass, prior to placing it into a broken glass box. 5. After removing any sharps, cover the biological spill with a paper towel or other absorbent. 6. Lay absorbent, paper towels, or similar material on top of the spill. Pour the disinfecting solution onto the towels. Allow the disinfecting solution to remain in contact with the spill for a minimum of 15 minutes. 7. Place the used absorbents into an infectious waste container 8. Clean the surface a 2 nd time, again using the disinfectant. 9. Remove the PPE and wash your hands thoroughly. 12

14 Appendix C Treatment of Biological Waste using a Sodium Hypochlorite Solution 1. This treatment option is often used for tissue culture liquid suspensions, which will allow the sodium hypochlorite solution to come in direct contact with the organism. 2. The sodium hypochlorite solution must be mixed immediately prior to each use and contain a 15% by volume household bleach in water. 3. The cultures must be submerged in the bleach solution for at least 20 minutes, prior to pouring down the sanitary sewer system. 4. The laboratories using this method of treatment should ensure that the cultures or waste containers are labeled and handled appropriately, as household bleach is corrosive, irritating and toxic. 13

15 Appendix D Treatment of Biological Waste using the University Autoclave Otterbein s autoclave is housed in the Biology & Earth Science Department stockroom (116A). Completing an Autoclave Waste Cycle When a biological waste is passed through the autoclave it should have the following: A weight associated with the bag, prior to autoclaving the waste. Pass through a steam sterilization cycle at degrees C, with 15 lbs. of pressure for 60 minutes. cycle. Autoclave tape is used for an immediate indication that the waste has completed a full sterilization A second approved indicator that the sterilization cycle was completed properly. Approved verification types are a digital reading from the autoclave indicating a complete cycle, or a biological or chemical indicator showing that the sterilization process was complete. Storage of Biological Waste Generators of biological waste are not permitted to store infectious waste for more than 35 days. In Use sharps containers are not considered storage. Record Keeping The autoclave efficiency will be tested monthly by the person in charge of the stockroom using a Raven Prospore Ampoule containing Geobacillus stearothermophilus spores All efficiency testing will be documented and records will be maintained by the person in charge of the stockroom. A Monthly Infectious Waste Generation log (MIWGlog) should also be maintained for each individual laboratory generating biological waste. According to the Ohio Infectious waste regulations, as a small quantity generator we are permitted 50 pounds of infectious waste in any calendar month, per generator. Each individual lab generating biological waste can be considered a separate generator. The waste log should indicate what type of waste was disposed of, who treated it, how it was treated and who the generator was (individual lab). All biohazard waste bags should be labeled properly using a biological waste label. The waste label will indicate the name of the institution completing the disposal, the person who completed the treatment, the method of the treatment, the bag number and weight of the bag and the date the disposal was completed. All biohazard waste that has been decontaminated by the autoclave procedure, can be discarded in the regular trash, with the biological waste label indicated its decontamination attached. Place all biohazard bags in a secondary brown or black trash bag to reassure others that the waste is no longer a biohazard. 14