TSE Laboratory Checklist

This questionnaire is provided to you as a tool to be used in conjunction with the Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents, 1st edition 2005, as well as the Containment Standards for Veterinary Facilities (CSVF), 1st edition 1996.

TSE material:

This checklist is intended to assist TSE laboratories in determining their compliance with the Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents.

Please provide YES, NO, N/A (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 biological safety cabinet, decontamination procedures used, etc.).

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.

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Physical Requirements

1 - Location & Access

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is the laboratory separated from public areas by a door?
Is access limited to authorized personnel?
Do doors provide restricted access by a controlled access system (eg. key card, locking hardware) or equivalent? Does not apply to areas within the facility.
Do room doors have appropriate signage (i.e. biohazard sign, containment level, contact information, entry requirements)?
Is entry provided via an anteroom?
Does entry allow for separation of personal clothing from dedicated facility clothing (i.e. "clean" change area separated from "dirty" change area)?
Are office areas located outside of containment perimeter? Paperwork stations for data collection can be within containment provided they are located away from laboratory work areas.
Do door openings allow passage of required equipment (i.e. may be greater than standard width and height in accordance with equipment size)?

 

2 - Surfaces Finishes

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are doors and frames non-absorptive and have solid finishes (i.e. unfinished wood is not acceptable)?
Are hollow doors be sealed?
Are interior surfaces (eg. floors, walls, benches, casework, etc.) non-absorptive and able to withstand decontamination methods (eg. sodium hypochlorite or sodium hydroxide)?
Are interior coatings cleanable?
Are interior surfaces continuous (flooring with welded seams is acceptable)?
Do interior surfaces provide impact resistance in accordance with function?
Are surfaces continuous and compatible with adjacent and overlapping materials to maintain adhesion and a continuous perimeter?
Is continuity of seal maintained between the floor and wall (a cove floor finish up the wall is recommended)?
Are floors slip-resistant?
Are bench tops continuous?
Can bench tops contain spill of material (eg. with marine edges and drip stops)?

 

3 - 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 and below the work surface?
Are windows positioned on containment perimeter sealed in place?
Is the autoclave capable of achieving at least 134°C or 121°C if a two-step (chemical then heat) process is used?
Is a double door autoclave located on the containment perimeter?
Is an autoclave located within containment perimeter?
If it is not possible to locate the autoclave at or within the containment perimeter, then are strict waste control procedures implemented for the transport of waste and equipment in leakproof and impact resistant containers to a suitable autoclave within the facility?
Is the body of autoclave located, for ease of maintenance, outside of containment?
Is the autoclave located at the perimeter equipped with an interlocking mechanism to prevent both doors from opening at the same time?
Is the autoclave equipped with a cycle log recorder (i.e. to record time, temperature, and pressure)?
Are area for chemical decontamination of materials and equipment available?
Are other accepted technologies for decontamination, (eg. incineration, chemical dunk tank, alkaline hydrolysis) provided at or within the containment perimeter?
If not possible to install other accepted technologies on the perimeter or inside, then are strict waste control procedures implemented for the transport of waste to such systems?

 

4 - Air Handling

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Is the appropriate ventilation provided for use of caustic chemicals?
Is the laboratory equipped with a BSC?
Is a risk assessment done to determine the type of BSC required (i.e. hard ducted vs. recirculating cabinet)?
Do BSCs have bag in/bag out HEPA filters?
Where bag in/bag out HEPA filtered BSC's are not available, then is a procedure in place for the safe removal of HEPA filters?
Are supply and exhaust air diffusers not interfering with the operation of BSCs and fume hoods?
Is exhaust air system independent of other areas?

 

5 - Facility Services

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Are drains and associated piping (including autoclave chamber condensate) separated from lower levels of containment (i.e. connected to a liquid effluent treatment system as appropriate)?
If effluent treatment is present, are drains connected to effluent treatment sloped towards treatment system to ensure gravity flow? Is consideration given to the installation of valves to isolate sections for decontamination? Is piping heat and chemical resistant consistent with application? Are joints made by thermo/chemical fusible means or welding to ensure integrity of entire system in accordance with pressure decay testing specified in the Containment Standards for Veterinary Facilities?
Are floor drains installed only when essential?
Are floor drains installed only when essential?
Is domestic water branch piping provided with backflow prevention, in accordance with CAN/CSA-B64.10-01/B64.10.1-01? Is the isolation valve located in close proximity to the containment perimeter?
Are compressed gas cylinders (with the exception of fire extinguishers) located outside the containment perimeter?
If required, are portable vacuum pumps provided with device to minimize internal contamination of vacuum pump (eg. equivalent of HEPA filtration of vacuum line, use of disinfectant traps)?
Are handwashing sinks provided near the point of exit or in anteroom?
Are handwashing sinks provided with "hands-free" capability?
Are emergency eyewash stations provided in containment in accordance with activities and applicable regulations (i.e. ANSI Z358.1-2004 )?
Is an emergency shower equipment provided in containment in accordance with activities and applicable regulations (i.e. ANSI Z358.1-2004)?
Are water seals maintained in drainage traps through regular sink usage, seal primer, or by filling traps in areas that are not used regularly?
Are plumbing vent lines heat or chemical resistant consistent with application?
Are supply conduit and wiring sealed at and below the work surface to ensure surface decontamination is possible?
Are power system circuit breakers located outside containment perimeter?
Are life-safety systems, lighting, BSCs and other essential equipment supported by emergency power? If BSCs are not supported by emergency power then are procedures in place for exiting the facility?
Is a communication system provided between inside and outside of containment perimeter?
Is a system (eg. fax, computer) to transfer information and data electronically to outside containment available?

 

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Operational Requirements

Questions	YES/NO/NA (see above if NO or NA)	Comments	Mandatory Recommended
Have personnel demonstrated proficiency in handling infectious tissues and materials?
Have all protocols specific to the operation of the laboratory been developed, read and understood by personnel? Do employees certify in writing that they have understood the material in the protocols? Do protocols include entry and exit procedures for people, equipment, samples and waste. Are general protocols supplemented with protocols specific to each project in progress?
Are protocols in place for the effective decontamination of all laboratory waste, re-usable equipment, and laboratory space? If contaminated materials or liquids (such as reagents for washing, staining, etc.) are to be released to sanitary sewer then are they decontaminated before release?
Is the laboratory personnel trained in, and follow, the safe use of laboratory equipment, biological safety cabinets, procedures to minimize the production of aerosols, decontamination and emergency response?
Is an exposure protocol developed, posted and communicated to staff in the event of accidental inoculation or splashing into mouth or eyes? Is training in the application of this protocol documented?
Are open wounds, cuts, scratches and grazes covered with waterproof dressings?
Are eating, chewing gum, drinking, smoking, storing food, and applying cosmetics prohibited in the containment area?
Are personal items such as, purses and outdoor clothing not be brought into the containment laboratory?
Is long hair tied back so that it cannot come into contact with hands, specimens, containers or equipment?
Are laboratory doors kept closed to control access?
Are entries to the laboratory logged?
Is the laboratory a dedicated facility?
Are equipments that will be used for work with TSE agents dedicated?
If dedicated equipment is not available, then is an effective decontamination protocol in place? Consideration should be given to disposable equipment.
Is personal clothing kept separate from dedicated facility clothing?
Is a job hazard analysis (JHA) conducted in the facility to examine each procedure, identify risks and develop safe work practices that include appropriate PPE? Selection of appropriate PPE will depend on the amount and nature of infectious material as well as the procedures being used.
Do personnel entering the facility remove jewellery?
Do personnel entering the facility don solid-front gowns with tight-fitting cuffs, gloves, shoecovers or dedicated footwear? In general, solid front gowns are preferable to lab coats for preventing contamination of clothing. In general, solid front gowns are preferable to lab coats for preventing contamination of clothing.
Is consideration given to disposable labwear?
Are double gloves worn when handling infectious materials? Disposable sleeve covers are recommended for handling and manipulating infectious tissue.
Is a full face protection, such as dedicated glasses or eye protection with a mask or a face shield, worn for any procedures in which splashing and/or flying particles may be a hazard? A respirator is not a requirement however when respirators are used a respiratory protection program must be in place as per the applicable Provincial and Federal (eg. Canada Labor Code) regulations.
In case of a spill or splash, are face shields and dedicated eye protection decontaminated? Cuts and punctures are to be avoided by minimizing the use of sharp knives, scalpels and blades.
Are procedures which generate, or may generate, aerosols or splashes conducted in a BSC? if this is not possible, are other primary containment devices in combination with personal protective clothing and equipment used?
Are enclosed homogenization systems placed in a BSC where possible?
Is centrifugation of infectious materials carried out in sealed safety cups or rotors that are loaded and unloaded in a BSC?
To minimize contamination of work surface in the BSC, is work conducted within a tray or container, or on absorbent coverings provided they do not interfere with the functioning of the BSC? Consideration should be given to absorbent coverings that can be incinerated after use.
When handling known positive material, is consideration given to the use of disposable laboratory supplies (eg. forceps, embedding molds)?
Are outer gloves removed prior to exiting the BSC?
Are work surfaces decontaminated after work with contaminated material is completed? Where absorbent coverings are used, are they discarded as waste once work is completed?
Is microtome work done in a dedicated low traffic area? Is the area on the floor around the microtome taped off and in this area disposable shoecovers worn and removed as exiting, or other effective measure to prevent tracking of wax shavings?
Is routine laboratory cleaning done by personnel using the containment facility or by specific personnel dedicated and trained for this task?
Is the laboratory work area kept free from materials that are not required and cannot be easily decontaminated (eg. journals, books, correspondence)?
Are paperwork and report writing kept separate from areas where infectious materials are handled?
Are all contaminated material transported in closed, break resistant carriers when not in a BSC?
Are infectious agents stored inside the laboratory zone in leakproof containers?
Are agents stored outside the laboratory kept in leakproof containers in a locked freezer within a secure zone?
Are hands washed after removing inner gloves, and before leaving the laboratory?
Where disposable gowns are not worn, are contaminated clothing decontaminated prior to laundering?
Is efficacy monitoring of autoclaves using an appropriate temperature indicator or internal load probe done in every load? Are records of the results kept on file including cycle log records (i.e. time, temperature and pressure)?
Are heat sensitive materials that cannot be autoclaved decontaminated at the containment perimeter (eg. decontaminated using liquid chemicals, or other effective technology)?
Is an inventory of positive control material maintained and documented? Is access to this material controlled?