| Item |
Required Information |
Notes / Suggestions |
| A. Contacts |
- Provide name, title, email address, fax and phone numbers of a key contact
for inquiries regarding the submission contents.
- Provide current contact information for the institute director, principal
investigator (lab supervisor), facilities manager, and biosafety officer.
|
|
| B. Program Intent |
- Give a brief overview of the agents to be used and procedures to be
followed in your facility, as well as the general goal/purpose of the
work.
- Provide a list of pathogens manipulated and/or stored in the facility.
- Provide a list of animal species manipulated in the facility.
- A program change request must be submitted to this office before any new
pathogen is introduced in the facility.
- At any time there is a significant change in procedures, you are required
to inform this office immediately.
|
- Information to include: maximum volumes of infectious materials to be
worked with, identification of any procedures that may produce aerosols, etc.
|
| C. Certification Requirements |
Required for new facility certifications. It
is not necessary to submit this information during the re-certification
process.
- Provide description and/or specifications of all surface materials (e.g. walls, floors, benches, casework, etc).
- Provide a floor plan of facility with the containment barrier outlined and
appropriate; include room numbers.
|
|
| D. Verification & Performance Testing |
For each required test or verification, describe the test
procedure, acceptance criteria, observations, results, pass/fail decision,
names, dates, signatures, witnesses and corrective measures required. Testing
must have been performed during the last 12 months. |
|
| 1. Room Integrity |
- Provide confirmation that the integrity of all penetrations and seals
(at or below the work surface) on the containment perimeter
were confirmed visually - including all service penetrations (e.g. gas lines) and seals around doors, windows,
autoclaves, pass-through, dunk tanks, etc.
- Visually inspect floors, walls, and ceiling for cracks, chips or wear, and
verify integrity of wall/floor joints.
- List all defects, corrective measures and re-test results (if
applicable).
|
|
| 2. Communication Devices |
- Provide a list and a statement as to how they were verified as operational
(phone, intercom, radio, video, etc.).
|
- Communication should be maintained with minimum interruption during power
outage.
|
| 3. Access Control and Security Devices |
- List access control and security devices (e.g. key, proximity card, keypad, biometric reader)
on all entry points to the TSE laboratory (change rooms, anterooms, pass
through, etc).
- Provide verification that they operate as intended.
|
- Verify that a correct code/card works and also that an incorrect code/card
will not work.
|
| 4. Autoclaves & Disinfection Systems*
* If autoclave is used as a method of decontamination, it should be
verified.
|
Autoclave present at, within, or outside
containment:
- Autoclaves to be verified for operation as specified using representative
loads and to be tested microbiologically (121ºC ) or with thermocouples /
temperature probes (134ºC).
- Include the time/temperature criteria required for your specific
agent/waste and a description of the different types of loads to be run
(description of contents) and a description of the load test procedure (e.g. laundry, solid waste, liquid waste, etc.).
- Include an autoclave print out (time/temp log) and biological indicator or
thermocouple / temperature probe test results for each load test
performed.
- Confirmation that positive control results included and from the same
lot#.
- Confirmation that the autoclave is capable of achieving 134ºC (or
121ºC if a two-step process is used).
- If it is not possible to locate the autoclave at or within the containment
perimeter, provide waste control procedures for the transport of waste and
equipment in leak proof and impact resistant containers to a suitable autoclave
within the facility.
- Confirmation that all disinfection systems (e.g. dunk tanks, fumigation chambers, etc.) operate as intended and the system was verified
using representative loads tested microbiologically or with thermocouples /
temperature probes.
|
|
| 5. Backflow Preventers *
* Although this may not be a requirement for facilities handling
prion disease agents, if the system is in place, then testing should
occur.
* Only required in large animal facilities and in post mortem
rooms.
|
Only if water backflow preventers are
installed:
- Provide a list of all backflow preventers associated with the lab
(including type, general location, and purpose).
- Water supply backflow preventers must be tested in accordance with CAN/CSA -B64.10-07/B64.10.1-07 (or
that other municipal/provincial standards meet the CAN/CSA -B64.10-07/B64.10.1-07:
Manual for the Selection and Installation of Backflow Prevention
Devices/Manual for the Maintenance and Field Testing of Backflow Prevention
Devices (2007).
- Provide backflow preventers test certificates.
- Provide the name and certification number of the tester.
- Backflow prevention for other services (e.g. gases) to be verified to ensure that the system
will operate as specified.
|
- This helps ensure all backflow preventers are accounted for.
|
| 6. Effluent Treatment*
* Although this may not be a requirement for facilities handling
prion disease agents, if the system is in place, then testing should
occur.
*Only required in animal housing rooms where the room is the primary
containment barrier.
(Consult the Containment Standards for Veterinary Facilities)
|
Only if effluent treatment is installed:
- The system and run criteria are to be validated. Ideally, the methodology
should be discussed with the Office of Biohazard Containment and Safety,
CFIA.
- Briefly describe the run criteria for the specific agent/waste in use.
- Describe the verification procedures.
- Provide trending charts, test reports, digital printouts and other data as
pertinent.
- Drains and associated piping leading to effluent treatment systems
(including associated vent lines) to be tested in accordance with National
Plumbing Code of Canada, section 3.6 (1995); Canadian Commission on
Building and Fire Codes, National Research Council Canada. Pressure for air
test on drainage system shall be a factor of safety beyond standard code
requirements of 35 kPa (e.g. 2 x code).
|
- Complete this section if facility has a biowaste system, even if not
working with non-indigenous animal pathogens.
|
| 7. Biological Safety Cabinets *
* Required in laboratories and small animal facilities.
|
- Provide a list of all BSCs associated with the lab plus
the test certificate for each.
- Each BSC test
certificate must contain the following information:
- type of cabinet and type of exhaust connection (hard, thimble);
- standard to which the cabinet was tested and the qualifications of the
tester
- statement as to whether the HEPA filter was scanned or
probed, and the pass/fail criteria;
- when a unit cannot be tested to NSF 49, it must be tested to
manufacturer's specifications; the particle penetration given as a
percentage of the upstream challenge must be provided;
- indication of any repairs to HEPA filter(s) and subsequent
retest results;
- downflow and inflow (exhaust) measurements and acceptable ranges specific
for the model;
- alarm test results - airflow tests, failure alarm test.
- Provide the calibration certificates for the equipment used for the
verification (must be valid on date of test).
|
- This helps ensure all BSCs are accounted for.
|
| E. Biosafety Manual*
Note: the Biosafety Manual, which may consist of a
collection of Standard Operating Procedures (SOPs) is a critical part of the
certification documentation. Please realize that fulfilling the requirements of
this section entails a substantial amount of work and detail. Do not leave this
section until project completion.
* In re-certification submissions: a statement is required that
there have been no changes to the program. If there are new agents or
procedures in use, please submit the appropriate safety and operational
procedures for review.
Refer to the Biosafety Manual Requirements Checklist for Facilities
Handling Prion Disease Agents available on the CFIA website for more details
on the requirements to be included in the facility's Biosafety Manual.
|
- Roles and responsibilities
- Conditions of access
- Training
- Supervision period, demonstrated capability, training records.
- Employee health and medical surveillance
- Entry/exit
- Personnel, materials, equipment, animals, and waste.
- Personal protective equipment
- Use, maintenance, decontamination.
- Respiratory protection program if applicable.
- Transportation, handling and storage of pathogens
- Movement within the containment suite, inventory and access, receiving and
shipping.
- Decontamination and disinfection
- Disinfectant selection, use, shelf life daily procedures, special
considerations.
- Waste segregation, storage and package.
- Procedure for the safe removal of BSC HEPA filters.
- Housekeeping
- Animal care and safety if applicable
- Animal caging systems, use of cage dumping stations.
- Animal allergens, restraint mechanisms, proper handling techniques.
- Protocols for post-mortem areas, animal carcass movement and
transport.
- Emergency response
- Failures (power, BSC,
effluent treatment system).
- Spills (biological - inside BSC, outside BSC, outside facility).
- Animal escape.
- Medical emergency within containment.
- Specific… earthquakes, flood, etc.
- Incident reporting
- Requirements/definitions.
|
- This section should be submitted in a separate binder.
- The list is not exhaustive and will change depending on the facility and
program.
- Please feel free to contact this office for more information on the
required components of an institutional biosafety program or for specific
procedure requirements.
|