Information
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Address
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Document No.
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Audit Title
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Lab Room Number
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Biosafety Permit Number(s)
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Containment Level
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Principal Investigator
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PI Signature
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Conducted on
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Prepared by
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Personnel
Physical Requirements - CL2
Structure & Location
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Are containment zones and associated corridors to be separated from public and administrative areas by a door?
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Are there any dedicated paper/computer work stations within the containment zone?
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Are these dedicated paper/computer work stations within the containment zone segregated from laboratory work stations?
Containment Barrier
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Are there any openable windows positioned on the containment barrier?
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Do these include effective pest control?
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Do these include effective security?
Access
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Are the doors to the containment zone lockable?
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Has appropriate biohazard warning signage been posted at the containment zone point(s) of entry?
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Does this signage include the international biohazard warning symbol?
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Does this signage include the wet-mop sign?
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Does this signage include the containment level?
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Does this signage include the name and telephone number(s) of contact person(s)?
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Does this signage include the entry requirements?
Surface Finishes & Casework
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Are floors slip-resistant in accordance with function?
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Are all doors, frames, casework, bench-tops and laboratory furniture (e.g., stools, chairs) constructed from non-absorbent materials? <br>
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Are all wood surfaces in CL2 laboratory work areas sealed to be non-absorbent?
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Are surfaces and interior coatings cleanable and resistant to scratches, stains, moisture, chemicals, heat, impact, repeated decontamination, and high pressure washing, in accordance with function?
Air Handling
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Does the HVAC system provide sufficient air changes per hour (AC/hr) under normal operation to maintain airflow, based on facility function?
Facilities
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Have handwashing sinks been provided?
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Are they located as close as possible to the point(s) of exit of the containment zone?
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Have emergency eyewash and shower equipment been provided in accordance with containment zone activities?
Essential Biosafety Equipment
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Are BSCs, when present, located away from high traffic areas, doors, windows, and air supply/exhaust diffusers?
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Have process equipment, closed systems, and other primary containment devices been designed to prevent the release of infectious material or toxins?
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Have certified BSCs and other primary containment devices been provided?
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Was this determined by a Local Risk Assessment (LRA)?
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Are technologies (autoclaves) for the decontamination of contaminated materials provided within the containment zone?<br>
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Are procedures are in place to transport waste securely out of the containment zone to an appropriate decontamination area?
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Are vacuum systems (Aspirators) equipped with a device to prevent internal contamination?
Operational Procedures - CL2
Biosafety Program Management
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Has a Local Risk Assessment (LRA) been conducted and documented to examine each activity, identify risks, and develop safe work practices?
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Is a respiratory protection program in place when respirators are in use?
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Has the Biosafety Manual been supplemented and updated with SOPs (Lab Safety Manual) specific to the nature of the work being conducted in the containment zone and to each project or activity, as applicable?<br>
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Has a biosecurity plan been implemented?
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Is the biosecurity plan based on a biosecurity risk assessment?
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Has it been evaluated and improved as necessary?
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Has it been kept up to date?
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Has the inventory of infectious material and toxins handled or stored in the containment zone been maintained?
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Is the inventory kept up to date?
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Are all infectious material or toxins stored outside the CL2 and/or CL3 zones included in the inventory?
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Are records pertaining to importation requirements retained for 2 years following the date of disposal, complete transfer or inactivation of the imported infectious material or toxin? <br>
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Are the records made available upon request?
Medical Surveillance Program
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Has a medical surveillance program been developed?<br>
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Is it based on an overarching risk assessment and Local Risk Assessments (LRAs)?
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Has the medical surveillance program been implemented?
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Has it been kept up to date?
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Are containment zone personnel required to immediately notify their supervisor of any illness caused by, or that may have been caused by, the infectious material or toxins being handled or stored? (Laboratory Acquired Infection (LAI))<br>
Training Program
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Has a training needs assessment been conducted?
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Has a training program been implemented?
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Is the training program based on a training needs assessment?
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Has the training program been evaluated and improved as necessary?
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Is it kept up to date?
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Have personnel been trained on the relevant components of the Biosafety Manual / SOPs?
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Is the training as determined by the training needs assessment?
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Have personnel been trained on the potential hazards associated with the work involved?
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Does this include the necessary precautions to prevent exposure to, or release of, infectious material or toxins?
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Does this include the signs and symptoms of disease caused by the infectious material or toxins in use?
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Have personnel been trained on the relevant physical operation and design of the containment zone and systems?
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Have personnel been trained on the correct use and operation of lab equipment?
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Does this include primary containment devices?
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Are all visitors, maintenance / janitorial staff, contractors, and others who require temporary access to the containment zone trained and/or accompanied in accordance with their anticipated activities in the containment zone?
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Are personnel required to demonstrate knowledge of and proficiency in the SOPs on which they were trained?
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Are trainees always supervised by authorized personnel when engaging in activities with infectious material and toxins until they have fulfilled the training requirements?
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Has training and refresher training been documented?
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Have training records been retained?
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Is refresher training on emergency response procedures provided annually?
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Is a review of training needs conducted at minimum annually?
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Has additional or refresher training been provided when warranted by a change in the biosafety program?
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Has additional or refresher training been provided as determined by the review process?
Personal Protective Equipment
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Is appropriate, dedicated PPE (gloves, eye protection, lab coats etc…), specific to each containment zone, to be donned in accordance with entry procedures?
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Is the PPE to be exclusively worn and stored in the containment zone?
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Is face protection required to be used where there is a risk of exposure to splashes or flying objects?
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Are gloves required to be worn when handling infectious material, toxins, or infected animals?
Entry and Exit of Personnel, Animals, and Materials
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Are containment zone doors required to be kept closed?
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Is access to containment zone limited to authorized personnel and authorized visitors?
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Are current entry requirements posted at the entry to the containment zone?
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Is personal clothing (including backpacks and purses) required to be stored separately from dedicated PPE?
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Are personal belongings required to be kept separate from areas where infectious material or toxins are handled or stored?
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Are personnel required to doff dedicated PPE in a manner that minimizes contamination of the skin and hair?<br>when exiting the containment zone.
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Is this in accordance with SOPs?
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Are personnel required to wash hands after handling infectious materials or toxins, and when exiting the containment zone. (One Glove Rule)
Work Practices
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Is contact of the face or mucous membranes with items that are contaminated, or potentially contaminated, with infectious material or toxins prohibited?
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Is hair that may become contaminated when working in the containment zone required to be restrained or covered?
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Is the type of footwear worn required to be selected so as to prevent injuries and incidents?
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Is this as per the Local Risk Assessment (LRA)?
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Is this in accordance with the containment zone function?
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Is oral pipetting of any substance prohibited?
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Are open wounds, cuts, scratches, and grazes required to be covered with waterproof dressings?
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Have traffic flow patterns from clean to dirty areas been established?
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Are the established traffic patterns followed?
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Is this per the Local Risk Assessment (LRA)?
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Have dedicated paper/computer work areas been established for paperwork and report writing?
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Is the use of needles, syringes, and other sharp objects strictly limited?
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Is bending, shearing, re-capping, or removing needles from syringes required to be avoided?
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When necessary, is this performed in accordance with SOPs?
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Are work surfaces to be cleaned and decontaminated with a disinfectant effective against the infectious material in use, or a neutralizing chemical effective against the toxins in use?
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Is this at a frequency to minimize the potential of exposure to infectious material or toxins?
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Were all biosafety cabinets (BSCs) certified upon initial installation?
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Are BSCs re-certified annually?
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Are BSCs re-certified after any repairs?
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Are BSCs re-certified after any relocation?
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Does certification include verification of correct operation by in situ testing?
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Is this in accordance with NSF/ANSI 49, or where not applicable, with manufacturer specifications?
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Are good microbiological lab practices employed?
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Are samples of infectious material or toxins required to be opened only in containment zones that meet the containment level requirements to which that infectious material or toxin has been assigned? (Risk Group 2 (RG2) used in CL2)
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Are containers of infectious material or toxins that are stored outside the containment zone labelled?
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Are these containers leakproof?
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Are these containers impact resistant?
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Are these containers kept either in locked storage equipment or within an area with limited access?
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Is a certified biosafety cabinet (BSC) required to be used for procedures that may produce infectious aerosols or aerosolized toxins, when aerosol generation cannot be contained through other methods?
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Is a certified BSC required to be used for procedures that involve high concentrations of infectious material or toxins?
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Is a certified BSC required to be used for procedures that involve large volumes of infectious material or toxins?
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Are gloves required to be removed before exiting the BSC?
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Is all centrifugation of infectious material where inhalation is the primary route of infection, required to be carried out in sealed safety cups (or rotors) that are unloaded in a BSC.
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Are sustained open flames prohibited in a BSC?
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Are on-demand, open flames required to be avoided?
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Do procedures prevent a leak, drop, spill, or similar event, during the movement of infectious material or toxins within the containment zone, or between containment zones within a building?<br>
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Are these procedures based on an LRA and in accordance with SOPs?
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Are large scale cultures of infectious material or toxins required to be contained within a closed system or other primary containment device?
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Is the collection of samples, addition of materials, or transfer of culture fluids from one closed system to another to be performed in a manner that prevents the release of aerosols?
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Are these operations also performed in a manner to avoid the contamination of exposed surfaces?
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Is experimentally infecting cells or other specimens derived from the person conducting the experiment prohibited?
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Are all containment zone (floors) required to be kept clean, free from obstructions, and free from materials that are in excess, not required, or that cannot be easily decontaminated?
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Is an effective rodent and insect control program required to be maintained?
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Are personnel required to conduct regular visual (monthly) inspections of the containment zone to identify faults and/or deterioration?
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When faults or deterioration are found, are corrective actions required to be taken?
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Are records of regular inspections of the containment zone, and corrective actions, retained?
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Are records of building and equipment maintenance required to be retained?
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Are records of building and equipment repair required to be retained?
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Are records of building and equipment inspection required to be retained?
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Are records of building and equipment testing or certification required to be retained?
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Are these activities in accordance with the function of the containment zone?
Decontamination and Waste Management
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Is gross contamination required to be removed prior to decontamination of surfaces and equipment?
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Is such gross contamination disposed of in accordance with SOPs?
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Are disinfectants effective against the infectious material and neutralizing chemicals effective against the toxins required to be available and used in the containment zone?
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Are sharps required to be discarded in containers that are leakproof, puncture-resistant, fitted with lids, and specifically designed for sharps waste?
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Are primary containment devices required to be decontaminated prior to maintenance?
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Is all clothing and PPE required to be decontaminated when a known or suspected exposure has occurred?
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Are contaminated liquids required to be decontaminated prior to release into sanitary sewers?
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Are contaminated materials and equipment required to be decontaminated?
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Are such materials and equipment required to be labelled as decontaminated prior to cleaning, disposal, or removal from the containment zone?
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Is this in accordance with SOPs?
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Are all decontamination equipment and processes required to be validated using representative loads?
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Are these routinely verified using application-specific biological indicators, chemical integrators, and/or parametric monitoring devices (e.g., temperature, pressure, concentration) consistent with the technology/method used? (Autoclaves)
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Is this in accordance with SOPs?
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Are all decontamination equipment and processes verified routinely?
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Is this based on an LRA?
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Are records of these actions retained? (BIs)
Emergency Response Planning
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Are incidents involving infectious material, toxins, or infected animals, or involving failure of containment systems required to be reported immediately to appropriate personnel?
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Is incident investigation required to be conducted and documented for any incident involving infectious material, toxins, infected animals, or failure of containment systems?
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Is this in order to determine the root cause(s)?
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Are records of incidents involving infectious material, toxins, infected animals, or losses of containment required to be retained?
