MEMORANDUM To: All personnel and students utilizing Dr. Norton's laboratory facilities. From: Dr. Robert A. Norton Date: 1 April, 1997 Re: Laboratory regulation compliance. Effective immediately the laboratory facilities contained in Animal Sciences Building Rooms 231, 235 will be designated as Biosafety Level 2 facilities containing select agents. As such these facilities fall under Federal regulations including Section 511 of Public Law 104-132 "The Antiterrorism and Effective Death Penalty Act of 1996" included in 42 CFR Part 72, Additional Requirements for Facilities Transferring or Receiving Select Agents; Final Rule, which make adherence to these requirements mandatory. Failure to comply with these regulations may result in denied access to the facilities and/or immediate job termination and/or federal prosecution. The complete set of rules included in 42 CFR Part 72 are attached and should be thoroughly reviewed. Biosafety Level 2 is defined as practices, equipment, and facilities applicable to clinical, diagnostic, teaching and other facilities in which work is done with the broad spectrum of indigenous moderate-risk agents present in the community and associated with human disease of varying severity. Biosafety Level 2 Standard Microbiological Practices (SMP) include the following: 1. Access to the laboratory is limited or restricted at the discretion of the laboratory director when experiments are in progress. 2. Persons will wash their hands after handling viable materials and animals, after removing gloves and before leaving the laboratory. 3. Eating, drinking, smoking or use of any form of tobacco product, handling contact lenses, and applying cosmetics are not permitted in work areas. People who wear contact lenses in laboratories will be required to wear goggles, safety glasses or a face shield. Food will not be brought into the laboratory at any time. 4. Mouth pipetting is prohibited. Mechanical pipetting devices will be used. 5. All procedures are performed carefully to minimize the creation of splashes and/or aerosols. 6. Work surfaces will be decontaminated at least once a day and after the completion of any task or spill of viable or suspect viable bacteria. Daily decontamination of all work surfaces will be logged on the Surface Decontamination Log Sheet, located in each laboratory. 7. All cultures, stocks, and other regulated wastes will be decontaminated before disposal by autoclaving or other approved decontamination method. Such materials outside the immediate laboratory needing decontamination will be placed in a durable, leakproof container, closed for transportation and returned to the laboratory for decontamination and disposal. All materials requiring decontamination will be done in such a way to comply with all applicable local, state, and federal regulations, before removal from the facility. 8. An insect and rodent control program will be in effect. Biological Safety Level 2 Special Practices are defined as those practices beyond those practices required in addition to those included in the Biosafety Level 2 Standard Microbiological Practices. Biological Safety Level 2 Special Practices include the following: 1. Access to the laboratory is limited or restricted by the laboratory director when work with infectious agents is in progress. Persons who are at increased risk in acquiring infection or for whom infection may be unusually hazardous are prohibited from entry into the laboratory. Persons who are immuno-suppressed may be at greater risk of acquiring infections and therefore, may be prohibited from entry into the laboratory. The laboratory director has the final responsibility of assessing each circumstance and determining who may enter and/or work in the laboratory. 2. The laboratory director will establish policies and procedures whereby only persons who have been advised of the potential hazard and meet specific entry requirements (e.g., immunization) enter the laboratory. 3. A hazard warning sign incorporating the universal biohazard symbol will be posted on the access door to the laboratory indicating that infectious agents are located in the laboratory. The hazard warning will also be accompanied by a list of the infectious agent(s) present as well as the name and telephone number of the laboratory director and other responsible personnel. Special requirements for entry into the laboratory will be listed. 4. Laboratory personnel will receive appropriate immunizations or tests for the agents handled or potentially present in the laboratory. 5. When appropriate, considering the agent(s) handled, baseline serum samples for laboratory and other at-risk personnel having access to the laboratory may be collected and stored. Additional serum samples may be periodically collected, depending on the agents handled. 6. A biosafety manual will be adopted. Personnel are advised that special hazards do exist in this laboratory and therefore are required to read and follow instructions on practices and procedures. 7. Laboratory personnel are required to receive appropriate training on potential hazards associated with the work involved in this laboratory, the necessary precautions to prevent exposure and exposure evaluation procedures. Personnel will receive annual updates and additional training as necessary for procedural or policy changes. 8. A high degree of precaution will always be taken with any contaminated sharp items, including needles and syringes, slides, pipettes, capillary tubes, and scalpels. Needles and syringes or other sharp instruments will be restricted in the laboratory and will be used only when there is no alternative. All needles and syringes will be stored in a locked cabinet which will be inventoried on a monthly basis. Removal of any syringes or needles will be done only after permission by the laboratory director or laboratory manager. Keys to this locked cabinet will be kept secure and will be accessible only by the laboratory director or laboratory manager. No temporary storage of either needles or syringes will be allowed. 9. Only needle-locking syringes or disposable syringe-needle units (i.e., needle is integral to the syringe) are used for injection or aspiration of infectious materials. Used disposable needle will not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal; rather, they will be carefully be placed in conveniently located puncture-resistant containers designated for sharps disposal. Non-disposable sharps will be placed in a hard-walled container for transport to a processing area for decontamination, preferably by autoclaving. 10. Broken glassware will not be handled directly by hand, but must be removed by mechanical means such as a brush and dustpan, tongs, or forceps. Containers of contaminated needles, sharp equipment, and broken glass will be decontaminated before disposal in accordance to all pertinent local, state, and federal regulations. 11. Cultures, tissues, or specimens of body fluids will be place in a container that prevents leakage during collection, handling, processing, storage, transport, or shipping. 12. Laboratory equipment and work surfaces will be decontaminated with an appropriate disinfectant on a routine basis, after work with infectious materials is finished, and especially after overt spills, splashes, or other contamination by infectious materials. Contaminated equipment will be decontaminated according to all local, state, or federal regulations before it is sent for repair or maintenance or packaged for transport in accordance with applicable local, state, or federal regulations, before removal from the facility. The decontamination of equipment prior to removal will be noted in the equipment log book. 13. Spills and accidents which result in overt exposure to infectious materials will be immediately reported to the laboratory director. Medical evaluation and surveillance will be provided as appropriate and a written incident report will be made. Copies of this report will be kept permanently in the laboratory incident file. Copies of this file will also be submitted to the Office of Safety and Environmental Health (Room 316, Nuclear Science Center), the Chairman of the Biosafety Review Committee, and the Department Head. 14. Animals not involved in the work being performed are not permitted in the laboratory. 15. Safety Equipment (Primary Barriers) 1. Properly maintained biological safety cabinet (Class II) or other appropriate personal protective equipment or physical containment devices will be used when: a. Procedures with a potential for creating infectious aerosols or splashes are conducted. This may include centrifuging, grinding, blending, vigorous shaking or mixing, sonic disruption, opening containers of infectious materials whose pressure may be different from ambient pressures, inoculating animals intranasally, and harvesting infected tissues from animals or eggs. b. High concentration or large volumes of infectious agents are used. Such materials may be centrifuged in the open laboratory if sealed rotor heads or centrifuge safety cups are used, and if these rotors or safety cups are opened only in a biological safety cabinet. 2. Face protection (goggles, mask, face shield or splatter guards) will be used for anticipated splashes or sprays of infectious or other hazardous materials to the face, when microorganisms must be manipulated outside the biological safety cabinet. 3. Protective laboratory coats, gowns, smocks, or uniforms designated for lab use will be worn while in the laboratory. This protective clothing will be removed and left in the laboratory before leaving for non-laboratory areas. All protective clothing will either be disposed of in the laboratory or will be laundered by the institution. The clothing will never be taken home by personnel. 4. Gloves will always be worn when handling infected animals and when hands may contact infectious materials, contaminated surfaces or equipment. Wearing of two pairs of gloves will be worn where appropriate. When or if contamination occurs the outer contaminated glove will be removed. Gloves will be disposed of when contaminated, removed when work with infectious materials is completed, and will not be worn outside the laboratory. Disposable gloves will not be washed or reused. 16. Laboratory Facilities (Secondary Barriers) 1. Each laboratory will contain a sink for hand washing. 2. The laboratory will be designed and arranged so that it can easily be cleaned. Rugs in the laboratory will not be permitted. 3. Bench tops will be impervious to water and resistant to acids, alkalis, organic solvents and moderate heat. 4. Laboratory furniture will be sturdy and spaces between benches, cabinets, and equipment are accessible for cleaning. 5. Laboratory windows will be kept closed. If open they will be fitted with fly screens. 6. A method for decontamination of infectious or regulated wastes is available (e.g., autoclave, chemical disinfection, incinerator , or other approved decontamination system). 7. An eyewash facility is readily available. I have read this memo thoroughly and understand and agree to abide with all requirements herein. I understand violation of these requirements could result in one or more of the following actions: A. Make me ineligible for access to this laboratory. B. Result in possible job termination. C. Result in possible prosecution under pertinent state and federal regulations. ________________________________ _________________ Employee Signature Date _________________________________ __________________ Laboratory Supervisor Date _________________________________ ___________________ Laboratory Director Date __________________________________ ___________________ Department Head Date Review Date: __________________
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