ࡱ> c w1bjbjԚ ;Z\Z\B(4ttttt8<!J"IIIIIII$LNI-tIttIiiittIiIii@EXPI1 uF*tII0!JFO;.OTPIOtPI$iIIi!JO> ::  Laboratory Biosafety Level 2 Inspection Report  IBC#_________ STATE UNIVERSITY OF NEW YORK College at Geneseo Institutional Biosafety CommitteeLab PI/Contact Person: Inspection Date: Inspected By: Lab Location (Bldg/Rm #) Dept: Phone #: Inspection Type: ( ) Initial ( ) Periodic Comment: List of Agents That Will Be Used/Stored: ( ) Recombinant DNA : ( ) Parasitic: ( ) Bacterial: ( ) Toxin: ( ) Viral: ( ) Prion: ( ) Fungal: ( ) Human: Biosafety Level 2 (BSL-2) is suitable for work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets (BSCs) or other physical containment equipment. BSL-2 is appropriate when work is done with any human-derived blood, body fluids, tissues, or primary human cell lines where the presence of an infectious agent may be unknown. If work with any human-derived blood or other potentially infectious human material is to be conducted, personnel are required to take the OSHA Bloodborne Pathogen training facilitated by the Office of Environmental Health and Safety and have the opportunity to take the Hepatitis B vaccination series.  BSL AGENTS PRACTICES SAFETY EQUIPMENT FACILITIES 2 Associated with human disease. Hazard: percutaneous injury, ingestion, mucous membrane exposure BSL-1 practices plus: Limited access Biohazard warning signs Sharps precautions Biosafety manual defining waste decontamination and medical surveillance policies Primary Barriers: Class I or II BSCs or other physical containment devices used for all manipulations of agents that cause splashes or aerosols of infectious organisms Personal Protective Equipment (PPE): lab coats, gloves, face protection as needed BSL-1 plus: Autoclave available  A. STANDARD MICROBIOLOGICAL PRACTICES FOR BSL-2YESNON/ACOMMENTS1. Is access to the laboratory limited or restricted at the discretion of the PI when experiments are in progress? 2. Are hand washing facilities available and do personnel wash hands after working with potentially hazardous material and before leaving the laboratory? 3. Are eating, drinking, smoking, applying cosmetics and food storage forbidden in laboratory areas and are signs posted to that effect on all refrigerators? 4. Are mechanical pipetting devices used and mouth pipetting prohibited? 5. Are policies and equipment in place for working with sharps (needles, scalpels, pipettes, broken glassware)? a. Is there a sharps container present and less than full? Is there a box for broken glass present that is less than 80% full? Does the box have only glass in it? 6. Is care taken to minimize the creation of splashes and aerosols? 7. Are work surfaces decontaminated with an appropriate disinfectant after completion of work and after any spill of potentially infectious material? 8. Are all cultures, stocks, and other potentially infectious material decontaminated (such as autoclaving) before disposal? 9. Is appropriate signage posted at the entrance to the laboratory to include the universal biohazard symbol? Note: Posted information must include the following: the labs biosafety level, the responsible persons name,telephone number, agent information, and required procedures for entry/exit. 10. Is an effective pest management program in place? 11. Has the PI provided appropriate training in regards to job duties, necessary precautions to prevent exposures, and exposure evaluation procedures?  B. Special Practices for BSL-2 YESNON/ACOMMENTSHave all personnel entering the lab been advised of the potential hazards and met specific entry/exit requirements (e.g. immunizations)?Have personnel been provided medical surveillance and offered appropriate immunizations for agents that may be present? Is there a policy/procedure in place describing the collection and storage of serum samples from at-risk personnel? Is there a laboratory-specific biosafety manual that includes standard operating procedures for biosafety and is it accessible to lab personnel? Has the PI ensured that all personnel demonstrate proficiency in standard and special microbiological practices before working with BSL-2 agents? Are there durable, leak proof containers available for collection, handling, processing, storage or transport of infectious materials within the facility? 7. Are there procedures in place for the routine decontamination of equipment after spills and in preparation for servicing? a. Is there a supply of agent appropriate decontamination solution ready for use? b. Is there a container of disinfectant in the BSC? Are there procedures to decontaminate shared or dual-use equipment? 8. Are incidents that result in exposure to infectious materials immediately evaluated and treated according to procedures described in the lab biosafety manual? 9. Are animals and plants not involved in research prohibited from the lab? 10. Are all procedures that may produce aerosolization* of infectious materials conducted in a BSC or other physical containment device? *aerosolization can occur from: pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, opening containers of infectious materials, inoculating animals intranasally, and harvesting infected tissues from animals or eggs. C. SAFETY EQUIPMENT (PRIMARY BARRIERS AND PPE)YESNON/ACOMMENTS1. Are BSCs, other physical containment equipment or PPE used when: Procedures with a potential for creating infectious aerosols are used? High concentrations or large volumes of infectious agents are used? 2. Are lab coats, gowns or smocks worn while working with hazardous materials? a. Are they removed before entering non-laboratory areas? b. Is there a procedure for disposal of protective clothing? 3. Are eye and face protection (goggles, mask, face shield) used for when manipulations of infectious material are performed outside of a BCS or other containment device? 4. Are gloves worn and special care taken to avoid skin contamination when working with infectious materials or animals? 5. Are BSCs maintained properly and certified annually? 6. Are eye, face and respiratory protection used in rooms containing infected animals as determined by a risk assessment? 7. Do centrifuges have sealed rotors and/or safety cups which are only opened inside a BSC?  D. LABORATORY FACILITIES (SECONDARY BARRIERS)YESNON/ACOMMENTSAre all laboratory doors self-closing and have locks? 2. Does the lab have a sink available for hand washing preferably near the exit door? 3. Is the laboratory designed for easy cleaning and decontamination? 4. Is laboratory furniture capable of supporting loads and uses? 5. Are bench tops made of material impervious to water and resistant to heat, organic solvents, acids, alkalis and other chemicals? 6. If the lab has windows that open, are they fitted with fly screens? 7. Are BSCs located away from doors, windows that can be opened, heavily traveled areas and other possible airflow disruptions? 8. Are vacuum lines protected with HEPA filters or their equivalent? Note: A liquid disinfectant trap may be required. 9. Is an eyewash station readily available? 10. Are lab chairs covered with a nonporous (no fabric) material that can be easily decontaminated? 11. Is there a method available for decontaminating wastes ( e.g. autoclave, chemical disinfection, incineration or other validated decontamination method)  INSPECTION FINDINGS Checklist Number Deficiencies Corrective Action Status       IBC Disposition: % Not approved % Approved %Provisionally approved for BSL-2 work Comments: IBC Chair Signature: Date: Signature of second inspector: Date:  NOTES: A. Laboratory Biosafety Manual If the PI chooses to adapt the CDCs Biosafety in Microbiological and Biomedical Laboratories (BMBL) as his/her biosafety manual, it can be found at this URL: http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm The components (all of which can be found in the BMBL) of an acceptable biosafety manual include the following: 1. Biosafety Level Descriptions a. Standard Practices and Principles b. Special Practices and Procedures c. Containment Devices d. Facility Design 2. Animal Safety Practices (if applicable) 3. Agent Summary Statements 4. Equipment Descriptions 5. Specimen Handling 6. Security 7. Waste 8. Special Laboratory Practices a. Tissue culture b. Toxins B. Other helpful references 1. NIH Guidelines for Research Involving Recombinant DNA Molecules http://www4.od.nih.gov/oba/ibc/ibcindexpg.htm 2. Bloodborne Pathogen regulation http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDAR DS&p_id=10051&p_text_version=FALSE 3. 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