TSE Diagnostic Laboratory Checklist

This checklist 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.

Facility Representative's Name:

Address:

Phone:
Fax:

CFIA Inspector's Name:

Address:

Phone:
Fax:

TSE material:

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 coating for surfaces, type of biological safety cabinet, etc.).

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

1- Organizational Structure

Item	Questions	YES / NO / N/A	Comments
Biological Safety Officer	Is there a Biological Safety Officer or individual responsible for biological safety?
Safety Procedures and Manuals	Is there a laboratory procedural or safety manual? Are the following SOP's specific to TSE's in place
Safety Procedures and Manuals	Entry/exit procedures (including PPE, controlled access, maintenance, etc.)
Safety Procedures and Manuals	TSE specimen reception and handling
Safety Procedures and Manuals	Decontamination and disinfection (waste, work surfaces, PPE, etc.)
Safety Procedures and Manuals	Spill of TSE contaminated material (eg. inside and outside the BSC, inside a centrifuge, etc.)
Safety Procedures and Manuals	TSE exposure control plan
Safety Procedures and Manuals	Waste stream (tissue/solvents/liquid/other)
Safety Procedures and Manuals	Safe removal of HEPA filter from BSC (where Bag in/bag out filters are not available)
Safety Procedures and Manuals	Power failure procedures (if BSCs are not supported by emergency power then procedures should be in place for exiting)
Safety Procedures and Manuals	Is there a copy of "Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents" available to lab staff?

2- Training

Item	Questions	YES / NO / N/A	Comments
Training	Have lab staff read and understood the safety manual and the TSE procedures?
Training	Do all persons in the laboratory know and follow the operational protocols for the projects in process?
Training	Is there written documentation of the training provided?
Training	Have the personnel demonstrated proficiency in handling infectious tissues and materials?
Training	Are housekeeping staff trained in the hazards associated with the imported material? (what kind of training do cleaners receive?)
Training	Are other staff entering the lab (e.g. maintenance workers) trained in hazards specific to the imported material? (what kind of training do maintenance workers receive)

3- Physical Requirements

Item	Questions	YES / NO / N/A	Comments
Access	Is access to laboratory restricted to authorized personnel? (locked or another method of controlled access)
Access	Does the entry allow for separation of personal clothing from dedicated laboratory clothing (i.e. "clean" change area separated from "dirty"; change area). Entry to laboratory via an anteroom is recommended.
Signs	Are biohazard signs posted on the laboratory doors: restricted entry entry requirements contact information
Offices	Are the office areas located outside of containment perimeter?
Offices	Are the paperwork stations in the labs located away from hazardous materials? (Paperwork stations for data collection can be within containment provided they are located away from laboratory work areas.)
Perimeter	Are doors and windows to the laboratory area kept closed?
Perimeter	Are all the mechanical, electrical and service piping penetrations sealed at and below the work surfaces?
Furnishings and Surfaces	Are bench tops, walls and floors cleanable and can withstand decontamination methods?
Furnishings and Surfaces	Are the bench tops sealed (no open seams)?
Furnishings and Surfaces	Are interior surfaces non-absorptive, continuous and compatible with adjacent and overlapping materials?
Furnishings and Surfaces	Are doors and frames non-absorptive?
Air Handling System	Does the HVAC system interfere with the airflows of biological safety cabinets? (check to make sure cabinets are not located directly under a supply diffuser)
Biological Safety Cabinets (BSC)	Are BSC's used when handling infectious material?
Biological Safety Cabinets (BSC)	Are BSC's certified annually in accordance with CSA Z316.3-95 or the applicable NSF Standard?
Biological Safety Cabinets (BSC)	Does the certification sticker indicate the date of next certification, to what standards the tests were performed and the name of the certifier?
Biological Safety Cabinets (BSC)	Is a copy of the certification report readily available?
Biological Safety Cabinets (BSC)	Is the BSC equipped with bag in/out filters (preferable) or does an SOP exist for safe removal of the filter?
Autoclaves	Is there an autoclave in the laboratory area? Recommended being located at the perimeter. Alternatively, located at exit from TSE area. Interim: if located elsewhere in facility, strict waste procedures must be implemented for transport of waste and equipment.
Autoclaves	Is the autoclave capable of achieving 134°C or 121°C if a two-step process is used?
Autoclaves	Is the autoclave equipped with a cycle log recorder?
Facility Services	If an effluent treatment is present, are the drains connected to effluent treatment sloped towards treatment system to ensure gravity?
Facility Services	Are hand washing sinks provided in the laboratory at the exit?
Facility Services	Is an emergency shower provided in the facility?
Facility Services	Is an emergency eyewash station provided in the facility?
Facility Services	Are the supply conduit and wiring sealed at and below the work surfaces?
Facility Services	Is a communication system provided between inside and outside of containment perimeter?
Pest Program	Is the laboratory proofed against vermin and insects? (check for dead flies and mouse droppings)

4- Operational Practices

Item	Questions	YES / NO / N/A	Comments
PPE	Are lab coats, gowns worn when working in the laboratory?
PPE	Are the lab coats worn only in the laboratory areas? Consideration should be given to disposable labwear.
PPE	Are gloves worn at all times in the TSE area?
PPE	Are double gloves worn when handling infectious materials?
PPE	Are cut and puncture resistant gloves (i.e.: Surgipath) used when handling sharps?
PPE	Is dedicated lab footwear used, or are shoecovers worn over street shoes?
PPE	Are eyewear/faceshields worn when aerosols generated?
PPE	Are hands washed after handling infectious materials and before leaving the laboratory?
PPE	Is eating, chewing gum, smoking, storing food and applying cosmetics prohibited?
PPE	Is long hair tied back so that it cannot come into contact with hands, specimens and equipment?
Decontamination	Are all contaminated materials decontaminated for TSE's before disposal? (how are the various items are treated - autoclaving / disinfection / incineration?)
Decontamination	Is equipment dedicated, where possible?
Decontamination	Is effective decontamination protocol in place for reusable equipment?
Decontamination	Has disposable labware and equipment been considered?
Decontamination	Is the pathological waste disposed of appropriately? (Incinderation/alkaline hydrolysis etc.)
Decontamination	Are potentially TSE contaminated work surfaces decontaminated at the end of the day? how?
Decontamination	Are the disinfectants used for decontamination effective against prion agents? Provide list
Decontamination	Is the efficacy of the autoclave monitored using appropriate indicators?
Decontamination	Are autoclave records of the efficacy testing kept on file?
Decontamination	Are the autoclave cycle log recordings kept on file?
Records	Are there records kept of the controlled or imported material?
Records	Do the records indicate where the controlled/ imported material was used/stored and the date of disposal?
Records	Is an inventory kept of all positive material?