Animal Pathogen Containment Level 3 Small Animal Certification Checklist

This questionnaire is provided to you as a tool to be used in conjunction with the Containment Standards for Veterinary Facilities (CSVF), 1^st edition 1996.

Building / Laboratory / Room No.:

Containment Level 3 small animal facilities handling imported animal pathogens require a physical inspection by CFIA before they will be certified. This checklist is intended to assist laboratories in determining their compliance with the. Containment Standards for Veterinary Facilities (CSVF).

Please check the applicable box YES, NO, N/A for not applicable to indicate the answer to each of the criteria listed. For "NO" or "N/A" answers please contact the Biohazard Containment and Safety Unit immediately to discuss and provide a brief clarification/justification. For "YES" please provide any additional relevant information (i.e. type of coating for surfaces etc.). When responding to questions pertaining to the Drawings and Specifications please indicate the drawing number to which the information may be found and likewise for the specifications.

This questionnaire is subject to change by the Biohazard Containment and Safety (BCS) Unit at CFIA. The BCS Unit will make any changes or updates available to the regulated parties via our website, email, mail or other.

NOTE: "Small animals" are defined as animals housed in ventilated containment cages. A "SA facility (zone)" is defined as an area of equal containment level. An "animal room" is defined as the room in which the animals are housed. The containment perimeter/barrier of the SA facility zone is continuous and non-intersecting (i.e. the zone is serviced by a single entry/exit).

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Physical Requirements

1 - Location & Access

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are SA facilities zones separated from other laboratory activities?
Is access to the SA facility zone dedicated and controlled?
Is access to SA facility zone limited to authorized personnel?
Is access dedicated and controlled within the SA facility zone and into each animal room?
Do SA facility doors have appropriate signage (i.e. hazard identification, name and phone number of contact person, entry requirements)?
Are animal rooms and cages labelled with unique hazards, personal protective clothing and equipment to be used (i.e. entry requirements)?
Are personnel and animal entry to SA facility zone done via ventilated airlock with interlocks, warning light or audible alarm?
Is entry to SA facility zone provided with clothing change area to separate personal clothing from SA facility clothing dedicated to that zone (i.e. clean and dirty change areas)?
Is entry to SA facility zone provided with a shower on the containment barrier, separating clean and dirty change areas?
Do controlled entrance/exit doors have emergency manual overrides?
Are containment barrier support systems (e.g. HEPA filters, effluent sterilization system) located as close as possible to the SA facility zone?
Are office areas (i.e. a separated room providing a support function normally requiring no containment principles) located outside of SA facility zone?
If clerical work stations for animal handlers exit within SA facility zone, then are they located outside of animal rooms and corridors?
Are feed and bedding storage areas provided within the SA facility?
Are clean and dirty cage washing areas provided within the SA facility (cage washer may be located on containment barrier)?
Are experimental areas (i.e. for necropsy, surgical procedures, etc.) separate from animal rooms provided?
Are experimental areas provided with a BSC for manipulation of animals infected with a zoonotic agent?
Is the new SA animal facility level 3 located away from exterior envelope walls?

Sign off by responsible authority (print name, title, date and signature):

2 - Surfaces

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are interior coatings gas and chemical resistant in accordance with facility function?
Are interior surfaces continuous?
Do interior surfaces minimize movement of gases and liquids through perimeter membrane?
Are interior surfaces impact resistant in accordance with facility function?
Are interior surfaces compatible with adjacent and overlapping materials (continuous perimeter)?
Is continuity of seal maintained between the floor and wall?
Are floors slip-resistant and cleanable?
Are doors and frames non-absorptive with solid finishes; hollow doors sealed?

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3 - Furnishings

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are surfaces scratch, stain, moisture, chemical and heat resistant in accordance with function?
Are solid-core materials (not wood) used?
Is stainless steel construction used in SA facility?
Are floor contact surfaces rust resistant (except where stainless steel is used)?
Are bench tops continuous?
Can bench tops contain spillage of materials (marine edges and drip stops)?
Do benches, doors, drawers, door handles, etc. have rounded rims and corners?
Are backsplashes continuous with work surfaces?
Are backsplashes installed tight to wall and sealed at wall-bench junction?
Are service raceway channels and upper cabinets sealed at junction to bench?
Are reagent shelves equipped with lip edges?
Are sinks integral with bench top where same material used?

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4 - SA facility services

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are exposed SA facility services piping with stand-offs for maintenance and cleaning?
Is the water supply control located outside SA facility zone?
Are supply water services provided with backflow prevention at the perimeter of SA facility zone?
Are water supply backflow prevention devices selected and tested in accordance with the Canadian Standards Association CAN/CS -B64.10-01/B64.10.1-01, Manual for the Selection and Installation of Backflow Prevention Devices/Manual for the Maintenance, and Field Testing of Backflow Prevention Devices (2001)?
Are compressed gas cylinders (with the exception of fire extinguishers) located outside of the SA facility zone?
Are supply gas services provided with backflow prevention at the perimeter of SA facility zone?
Is backflow prevention for other services (e.g. gases) verified to ensure system will operate as specified?
Are vacuum services provided from within SA facility zone?
Is the internal contamination of vacuum pump minimized (e.g. HEPA filtration of vacuum line, use of disinfectant traps)?
Are dedicated hand washing sinks with "hands-free" capability?
Are emergency eyewash facilities in accordance with facility activities and applicable regulations (i.e. ANSI Z358.1 Emergency Eyewash and Shower Equipment (1998)?
Are quantities of hazardous materials limited in SA facilities?
Where not possible to limit the quantity of hazardous materials, is an emergency shower equipment provided in accordance with facility activities and applicable regulations (i.e. ANSI Z358.1 Emergency Eyewash and Shower Equipment)?
Are drainage traps provided with required depth in accordance with air pressure differentials?
Are drains and associated piping (including autoclave chamber condensate) separated from other zones (go directly to main collector for sanitary sewer or liquid effluent treatment system as appropriate)?
For non-indigenous agents, are drains (including autoclave chamber condensate) and associated piping connected to an effluent sterilization system?
For indigenous agents, are drains (including autoclave chamber condensate) and associated piping connected to an effluent sterilization system consistent with facility activity and local regulations?
Are drains connected to effluent sterilization sloped towards sterilization system/ installation of valves to isolate sections for decontamination?
Are piping heat and chemical resistant/ joints by thermo/chemical fusible means or welding to ensure integrity (i.e. in accordance with pressure decay testing specified in Section 7; Containment Standards for Veterinary Facilities, 1996)?
Are drains and associated piping leading to liquid effluent treatment systems (including associated vent lines) tested in accordance with Section 3.6 of the Canadian Plumbing Code, Testing of Drainage and Venting Systems (1995); pressure for air test on drainage system shall be at a factor of safety beyond standard code requirements of 35 kPa (e.g. 2 X code)?
For non-indigenous agents, are plumbing vent lines (including effluent sterilization system) provided with filter of efficiency equivalent to HEPA?
For indigenous agents, are plumbing vent lines (including effluent sterilization system) provided with filter of efficiency equivalent to HEPA consistent with requirement for any effluent sterilization system?
Are plumbing vent lines heat-resistant consistent with application?
Are plumbing vent lines combined with areas of lower containment only when provided with a filter of efficiency equivalent to HEPA before the connection (i.e. upstream from the connection)?
Are all sterilization systems (e.g. autoclaves, liquid effluent treatment systems) verified for operation as specified and microbiologically tested using representative loads (for technologies based on heat - using Bacillus stearothermophilus; for technologies based on chemicals - using Bacillus subtilis spores)?
Are all disinfection systems (e.g. dunk tanks, fumigation chambers) verified for operation as specified and microbiologically tested using representative loads? Resistance of test organism representative of organisms likely to be encountered.
Are supply conduit and wiring sealed at the containment barrier?
Are power system circuit breakers located outside containment perimeter?
Are life-safety systems, lighting, biological safety cabinets, HVAC systems and other essential equipment supported by normal emergency power?
Is the emergency electrical generator tested under appropriate load conditions to ensure system will operate as specified?
Are security systems (e.g. controlled access, closed circuit TV) verified to ensure system will operate as specified?
Are communication system (e.g. intercom, telephone, fax) provided between facility area and outside SA facility zone?
Are communication and electronic paper transfer systems verified to ensure system will operate as specified?
Is the cage washer provided with temperature of final rinse water of at least 82°C?
Is the cage washer tested to ensure system will operate as specified?

Sign off by responsible authority (print name, title, date and signature):

5 - Containment Perimeter

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are all mechanical, electrical and service piping penetrations sealed at containment perimeter?
Do windows provide the required level of security?
Do windows allow direct access between outside of the SA facility and animal rooms not permitted?
Are door openings allowing passage of required equipment?
Is a dedicated double-door barrier autoclave located and sealed on containment barrier?
Is the body of the autoclave located for ease of maintenance, outside containment zone?
Is the barrier autoclave equipped with interlocking doors, or warning light or audible alarms?
Is the autoclave equipped with a cycle log recorder (time, temperature, and pressure)?
Are other proven technologies for sterilization provided at containment barrier?
Are other proven technologies for sterilization for non autoclavable materials provided at containment barrier (dunk tank, decontamination chamber)?
Is SA facility zone proofed against entry or exit of vermin or insects?
Is the containment perimeter kept closed to provide required containment of air systems?

Sign off by responsible authority (print name, title, date and signature):

6 - Air Handling System

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is there a minimum of 10 air changes per hour under normal operations?
Does exhaust from animal rooms provide specified # of air changes as required by the CCAC?
Is the HVAC air distribution designed to minimize dead air spaces within the SA facility zone?
Are supply and exhaust diffusers located to provide convection patterns that ensure airflow away from facility entrance?
Does the diffuser selection provide minimal throw velocities, i.e. < 15 m/m @ 1 m?
Are supply and exhaust diffusers, biological safety cabinets and fume hood locations taken into consideration?
Is inward directional airflow maintained across the containment barrier (generally achieved by minimum of 25 Pa difference or 10% offset between zones)?
Are pressure monitoring devices at the SA facility entrance monitoring pressure between containment zones?
Are room static pressure monitoring lines provided with filters of at least equal efficiency to HEPA filter?
Are audible alarms provided in and outside the SA facility to detect pressurization and air handling systems failure?
Is air supply HVAC system independent from adjacent zones (supply combined with areas of lower containment if provided with a bubble tight damper or HEPA filter after the connection)?
Is air exhaust HVAC system independent from adjacent zones (can be combined with areas of lower containment if provided with a HEPA filter before the connection)?
Is backdraft of contaminated air through air supply duct prevented?
Is air exhaust to be HEPA filtered?
Are roughing pre-filters provided to protect HEPA filters (in accordance with American Society of Heating, Refrigerating and Air-conditioning Engineers (ASHRAE) Standards 52.1-1992 Gravimetric and Dust-spot Procedures for Testing Air-Cleaning Devices Used in General Ventilation for Removing Particulate Matter)?
Are air supply and exhaust ducts equipped with bubble tight dampers to permit gaseous decontamination (can be same bubble tight damper as required for backdraft protection and for isolation of the HEPA filters)?
Are air supply and exhaust HVAC systems linked to prevent facility positive pressurization?
Are airflow control devices and duct sensors located downstream of the exhaust HEPA filter and upstream of the supply bubble tight damper or HEPA filter?
Are bubble tight dampers and HEPA filters located as close as possible to the containment perimeter?
Are all air supply and exhaust ductworks located outside the containment area accessible?
Are air supply and exhaust ductworks sealed airtight between the room perimeter and bubble tight damper (pressure decay test)?

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7 - HEPA filters

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are filters provided with a minimum efficiency of 99.97% at 0.3um in accordance with the Institute of Envirionmental Sciences IES-RP-CC-001-86 Recommended Practices for HEPA Filters (1986)?
Is in-situ integrity of HEPA filters verified by in-situ particle challenge testing using the scanning method according to IEST-RP-CC-006.2 (section 6.2) (particle penetration not to exceed 0.01%)?
Is static pressure of HEPA filters monitored by pressure monitoring devices (e.g. magnehelic gauges)?
Is integrity of other in-line filters (e.g. plumbing vent lines, gas supply lines, autoclave exhaust ducts) verified by particle challenge tests (filter efficiency to be equal to that of HEPA filter) or replaced as part of regular maintenance?

Sign off by responsible authority (print name, title, date and signature):

8 - HEPA Filter Housings

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are HEPA filter housings provided with bubble-tight dampers on air inlets and outlets for shut-off and isolation of the filter?
Are HEPA filter housings provided with upstream and downstream fumigation ports for in situ decontamination?
Are HEPA filter housings provided with upstream injection and downstream access ports to allow for in situ particle challenge tests by the scanning method?
Are HEPA filter housings leak tight in accordance with pressure decay testing specified ASME N510 Testing of Nuclear Air Treatment Systems (1989- Reaffirmed in 1995), rate of leakage not to exceed 0.1% of vol/min at 1000 Pa (4 inches w.g.) minimum test pressure?

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9 - Biological Safety Cabinets (BSC)

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is certification of BSCs by NSF accredited certifier in accordance with CSA Z316.3-95, Biological Containment Cabinets: Installation and Field Testing (1995) or NSF 49-2002 Class II (Laminar Flow) Biohazard Cabinetry?
Are valid calibration and verification certificates for the testing equipment used available?
Are BSCs located away from high traffic areas, doors and air supply/ exhaust ducts that may interrupt air flow patterns?
Do BSCs have minimum clearance of 30 cm provided between exhaust outlet on top cabinet and overhead obstructions
Is a 30 cm clearance provided on each side of the cabinet to allow for access?
Are propane gas outlets avoided in BSCs?
For ducted cabinets, are blowers on the exhaust located at the terminal end of the ductwork?
Does an exhaust flow failure signal an alarm to the user?
Is an interlock system installed to prevent pressurization of the cabinet?
Is an anti-backflow device installed to prevent reverse airflow through the HEPA filter?

Sign off by responsible authority (print name, title, date and signature):
 

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Operational Requirements

1. Safety Manual / Training

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is the SA facility reference material kept in the SA facility zone?
Do employees working in the containment area have general knowledge of the physical operation and design of the facility (e.g. air pressure gradients between zones, directional air flow patterns, alarm signals for air pressure failure, containment perimeter)?
Is a protocol specific to the operation of the facility developed and read by personnel?
Are entry/exit protocols for persons, animals, equipment, samples, waste, etc. written, posted and followed?
Are general protocols supplemented with protocols specific for each project in progress?
Are employees certifying in writing that they have understood the material in the protocol?
Are emergency procedures for entry/exit, spill clean-up, air handling/biosafety cabinet failure, fire, animal escape and other emergencies must be written, posted and followed in the event of life-threatening emergencies? (Personal health and safety are a priority)
Are exit protocols established whereby routine procedures are bypassed?
Is a reporting area identified where further steps must be taken (e.g. disinfecting footwear, changing, showering) prior to leaving?
Is personnel receiving training on the potential hazards associated with the work involved and the necessary precautions to prevent exposures to zoonotic agents and release of non-indigenous agents?
Is personnel showing evidence that they understood the training provided?
Is training documented and signed by both the employee and supervisor?
Are all persons (including visitors, maintenance staff, etc.) entering the containment area are trained and follow all relevant protocols for the project in process?
Is SA facility personnel trained in and follow the safe use of the facility equipment, biological safety cabinets, procedures to minimize the production of aerosols, decontamination and emergency response?
Do personnel demonstrate proficiency in microbiological practices and techniques (e.g. experience in handling infectious organisms or cell cultures)?
Are trainees accompanied by a trained staff member?
Is a health and medical surveillance program provided as recommended by Health Canada?

 

2. Entry Requirements

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is entry restricted to SA facility staff, animal handlers, maintenance staff and other persons on official business?
Are only persons meeting specific entry requirements (e.g. immunization, serum screening) allowed to enter containment area unless the facility has been appropriately decontaminated?
Are animal rooms labelled with unique hazards and entry requirements?
Are persons entering the containment facility well prepared and bring all materials they will need with them? If something has been forgotten, traffic patterns must still be adhered to (ie. do not go back to get it; either phone for someone to bring it or exit via proper protocols).
Are open-toed and high-heeled shoes forbidden in the SA facility?
Is long hair tied back so that it cannot come into contact with hands, specimens, containers, or equipment?
Are traffic flow patterns from clean to dirty areas established and adhered to (i.e. move from least to most contaminated areas)?
Are personal items such as purses and outdoor clothing kept outside the SA facility zone?
Is a containment check performed prior to entering the SA facility zone (ie. verify negative pressurization as designed)?
Is a smoke testing (i.e. with a smoke pencil) done periodically by facility staff to verify correct airflow?
Is personnel entering the SA facility zone removing street clothing and jewellery, and change into dedicated SA facility clothing and shoes?

 

3. Practices in Containment

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is a second layer of protective clothing (ie. solid-front gowns with tight-fitting wrists, gloves) worn over facility clothing when directly handling infectious materials (e.g. dedicated for use at the biological safety cabinet)?
Are gloves (e.g. intact vinyl or latex) worn when handling infectious materials?
Are metal mesh gloves worn underneath the latex or vinyl glove to provide protection from sharps and needles?
Is eye and face protection worn when it is necessary to guard against splashing hazardous materials, flying particles, and harmful light or other rays?
Are hands washed frequently (after handling infectious materials, after removing gloves, and before leaving the SA facility)?
Are open wounds, cuts, scratches and grazes covered with waterproof dressings?
Are eating, chewing gum, drinking, smoking, storing food, and applying cosmetics prohibited?
Are samples and supplies carried into the SA facility zone or passed through a ventilated pass-box?
Where the barrier autoclave is used to pass materials into the SA facility, has the autoclave been cycled prior to opening the outer "clean side" door?
Are all activities with infectious materials conducted in a biological safety cabinet?
Is work with open vessels containing infectious materials conducted on the open bench unauthorized?
Where it is not possible, are other physical containment devices in combination with personal protective clothing and equipment used?
Is centrifugation of infectious materials carried out in sealed safety cups or rotors that are loaded and unloaded in a biological safety cabinet?
Are HEPA-filtered respirators used for handling animals where infectious aerosols of zoonotic agents may be generated and cannot be contained within a primary containment device?
Is necropsy of small animals infected with a zoonotic agent and intranasal inoculations of animals conducted in a biological safety cabinet?
Are animals securely transported to the BSC?
Are infectious agents stored inside the SA facility zone?
Are agents stored outside the zone kept locked, in leakproof containers?
Are proper methods of restraint used to minimize scratches, bites and accidental self-inoculations?
Are all spills, accidents, overt or potential exposures to infectious materials, and losses of containment (e.g. positive pressurization) reported immediately to the SA facility supervisor?
Are written records of such incidents maintained?
Is the work area containing hazardous materials kept free from materials not pertinent to the work and that cannot be easily decontaminated (e.g. journals, books, correspondence)?
Are paperwork and report writing kept separate from such work areas?
Are water seals maintained in drainage traps (i.e. through regular sink/shower usage and/or by filling traps in areas that are not being used)?
Is the SA facility zone kept locked?
Are SA facility zone doors kept closed as required by the facility design?
Where necessary, if a clothing change is not performed on exit of each animal room, is disinfectant footbaths provided? (Effective disinfectant against the microorganisms of concern should be used and changed regularly in accordance with the active life of the disinfectant)
Are animal room doors kept closed as required?
Are containment caging systems used to contain aerosols?
Is infected animals cage housing appropriately labelled?
Is an effective rodent and insect control program maintained?

 

4. Decontamination / Exit

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are contaminated work surfaces decontaminated?
Is contaminated equipment leaving the SA facility for servicing or disposal appropriately decontaminated?
Are all waste materials leaving the SA facility zone decontaminated through a double-door autoclave at the barrier before disposal?
Is only one door of the double autoclave open at any time?
Are heat sensitive materials that cannot be autoclaved out of the SA facility zone decontaminated at the containment barrier (e.g. fumigated with formaldehyde or vaporized hydrogen peroxide, disinfected using liquid chemicals, or other technology proven to be effective)?
Are animal carcasses and tissues incinerated or processed through new technology proven effective (e.g. tissue autoclave) - carcasses transported from the animal room for disposal in leakproof and appropriately labelled containers?
Are all contaminated materials decontaminated before cleaning for reuse?
Is contaminated clothing decontaminated prior to laundering (unless laundering facilities are within the SA facility zone and have been proven to be effective in decontamination of the microorganisms likely to be encountered)?
Is efficacy monitoring of autoclaves using biological indicators done at least weekly, depending on the frequency of use of the autoclave, and records of the results kept on file?
Are cycle log records (i.e. time, temperature and pressure) kept on file?
Are cages autoclaved prior to washing? (Preferred method of decontaminating cages prior to washing- temperature of final rinse water at least 78°C)
Where full body protective clothing is not worn, is a shower taken on exit from the containment area?
Where a known or suspected aerosol exposure has occurred, (e.g. dropping infectious materials) is a shower taken on exit from the SA facility zone?
Is a shower (including washing hair, beards) taken on exit from a SA facility zone handling non-indigenous animal pathogens?
Are eye glasses disinfected at the containment barrier?

Sign off by responsible authority (print name, title, date and signature):
 

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Signatures:

Date

Date