Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
Canadian Food
Inspection Agency
Agence canadienne
d’inspection des aliments
Bureau du confinement des biorisques et de la sécurité
Direction générale des sciences, ACIA
1400 chemin Merivale, Ottawa, Ontario K1A 0Y9
Tél: (613) 773-6520 Téléc: (613) 773-6521
Courriel: ImportZoopath@inspection.gc.ca
Office of Biohazard Containment and Safety
Science Branch, CFIA
1400 Merivale Road, Ottawa, Ontario K1A 0Y9
Tel: (613) 773-6520 Fax: (613) 773-6521
Email: ImportZoopath@inspection.gc.ca
Inspection Checklist
Aquatic Animal Pathogen Containment Level 2 (AQC2)
In Vitro Facilities
Company Organization:Click here to enter Company organization name.
Mr.
Ms.
Dr.
Mr.
Click here to enter Applicant’s name
Ms.
Dr.
Click here to enter biological safety officer’s name.
Click here to enter address of containment zone.
Click here to enter biosafety officer’s address (if different from
precedent).
Click here to enter Applicant’s phone number.
Click here to enter BSO’s phone number.
Click here to enter Applicant’s fax number.
Click here to enter BSO’s fax number.
Click here to enter Applicant’s email address.
Click here to enter BSO’s email address.
Building(s) / Room(s) # where material will be
handled for in vitro work:
Click here to enter room #’s/ names.
This Inspection Checklist is used to verify compliance to physical and operational requirements and recommendations for containment level 2 aquatic facilities listed in the
Containment Standards for Facilities Handling Aquatic Animal Pathogens, 1st Edition, 2010.
SECTION I: GENERAL
No
1
1
2
Questions
Answers
Comments
Biological Safety
Is there a Biological Safety Officer (BSO) designated to oversee biosafety and biosecurity for the
containment facility?
(A biological safety committee may be used to assist the safety program. The BSO is to be present
during the inspection)
Is there a copy of the Containment Standards for Facilities Handling Aquatic Animal Pathogens available
to containment zone* staff?
(Staff must have read this document)
Click here to enter
No
a comment.
Yes
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No
a comment.
Yes
3
Is there a Biosafety Manual written and is it available to all staff?
(Review the manual. It needs to include a brief description of the containment zones,
how they operate, and the chain of events from receipt of infectious material to decontamination and
disposal)
Click here to enter
No
Yes
a comment.
* In this section, the expression «Containment zone» is used merely to simplify the text; it refers to laboratory room(s) where the aquatic animal pathogen(s) will be
handled and stored.
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Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
Questions
4
Is the Biosafety Manual reviewed and updated regularly?
5
2
6
7
8
9
10
Answers
Are there written emergency procedures for spill clean-up, BSC failure, power failure, animal escape, fire,
and other emergencies?
(Review these procedures. Spill procedures must include a section regarding the prevention of release of
contaminated materials into drainage systems unless linked to a decontamination system).
Comments
No
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Yes
a comment.
No
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Yes
a comment.
Training
Have containment zone staff read, received training in, and understood the Biosafety Manual?
(Ask a staff member if he read the manual, ask questions)
Do employees working in the containment zone have general knowledge of the physical operation and
design of the facility?
(Inward directional airflow, decontamination system, etc.)
Do all persons in the containment zone know, demonstrate competence, and follow the operational
protocols (SOPs) for the projects in process?
(Topics covered in SOPs should include staff training, document archiving, entry/exit, spill clean-up, air
handling/biosafety cabinet failure, fire, animal escape and other emergencies, waste treatment, biohazard
storage and disposal, etc.)
Are employees trained on the potential hazards associated with the work involved and the precautions
required to prevent exposure to infectious substances and potential zoonotic agents?
Does employee training include the review of Pathogen Safety Data Sheets (PSDS) for the pathogens
handled in the laboratory?
(Verify if they are available and used during training. If not publicly available, the applicant or trainer must
prepare their own)
No
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Yes
a comment.
No
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Yes
a comment.
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No
a comment.
Yes
No
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Yes
a comment.
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No
a comment.
Yes
Note: PSDS can be found on the CFIA and PHAC websites
11
Are refresher and retraining programs implemented as appropriate?
No
Yes
12
13
14
3
Is there written documentation of the training provided?
(Review this documentation. It must describe the training provided and be signed by the both the
employee and the supervisor)
Are the employees (researchers, technicians, etc.) working in the containment zone responsible for
housekeeping?
Are non-laboratory staff (e.g. janitors, maintenance workers, contractors) entering the containment zone
trained in the operational procedures for entry and exit and the hazards associated with the biohazardous
material?
(Review the training module(s) and visitor policy. Visitors and trainees to be accompanied by a trained
staff member)
No
Yes
a comment.
Click here to enter
a comment.
No
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Yes
a comment.
No
Yes
Access
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a comment.
Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
Questions
15
Is access to the containment zone restricted to persons on official business?
(Determine how - locks and/or signs)
16
17
18
19
20
21
Are doors and windows to the containment zone kept closed?
(Verify that they are all closed. Doorstops should not be present)
Is appropriate signage (biohazard signs) indicating the nature of the animal pathogens being used (i.e.
type, containment level, and entry requirements) posted on each entry door to the laboratory?
Do the signs list the name and phone number of the person to contact in case of emergency?
Are hooks or lockers provided at the entry/exit of the containment zone to allow the separate storage of
street clothing and personal protective equipment (e.g. lab coats)?
Are office areas located outside of working areas?
(Paperwork stations located away from hazardous materials are permitted within these areas)
Are the paperwork stations (and reference material area) in the containment zone located away from
hazardous materials?
Answers
Comments
No
Click here to
Yes
enter a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
Yes
No
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a comment.
N/A
4
22
23
24
Surfaces
Are the floors slip-resistant?
Are surfaces in the rooms scratch, stain, moisture, chemical, and heat resistant in accordance with
function?
(Are surfaces in good condition, cleanable and resistant to repeated disinfection? Doors, frames,
casework and bench-tops to be non -absorbent )
Are unfinished wood surfaces present in the containment zone?
No
Click here to enter
Yes
a comment.
No
Click here to enter
Yes
a comment.
No
Yes
25
5
Are the rooms kept neat, orderly and clean?
a comment.
No
Click here to enter
Yes
a comment.
Air Handling System and Biological Safety Cabinets
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Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
Questions
26
Does the containment zone have inward directional airflow?
(Check at doorway using a smoke pencil or tissue)
27
Answers
Does the HVAC system (Heating, Ventilation and Air Conditioning) interfere with the airflow of biological
safety cabinets?
(Check to make sure cabinets are not located directly under a supply diffuser)
Comments
No
Click here to enter
Yes
a comment.
Yes
No
Click here to enter
a comment.
N/A
28
Are Biological Safety Cabinets (BSCs) used when handling infectious material?
(BSC to be used when carrying out aerosol generating procedures or with high concentration/ large
volumes of infectious materials)
Click here to enter
Yes
a comment.
No
Note: Work with infectious material on the bench is permitted - supervisor must assess which procedures
are to be done in BSC.
29
Are employees using BSCs trained in their correct use and care and have a good understanding of their
operation?
(Verify training records and ask a staff member to describe the procedure)
N/A
Yes
No
Click here to enter
a comment.
N/A
30
Are BSCs certified in accordance with NSF/ANSI 49 Class II Biohazard Cabinetry at least annually?
(Check for certification sticker - some BSCs need to be certified according to manufacturer specifications)
Click here to enter
Yes
a comment.
No
N/A
31
Does the certification sticker indicate the date of next certification, to what standards the tests were
performed and the name of the certifier?
Yes
Click here to enter
No
a comment.
N/A
32
Is a copy of the certification report readily available?
(Ask to see a copy of the report)
Yes
Click here to enter
No
a comment.
N/A
6
33
34
35
36
Facility Services
Are emergency eyewash facilities and emergency shower equipment provided in the containment zone?
(In accordance with activities performed and applicable regulations i.e. ANSI Z358.1 Standard)
Are life-safety systems, lighting, and essential equipment supported by normal emergency power?
Is a hand washing sink provided in the containment zone? Is it located near the point of exit?
(Check to see if the sinks are of hands-free operation)
Is the facility proofed against vermin and insects?
(Do they have an exterminator contract; check for dead flies and mouse droppings)
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No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
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Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
7
37
38
39
Questions
Answers
Comments
Decontamination
Are all contaminated materials decontaminated before disposal or reuse including:
Click here to enter
·
solid and liquid wastes
·
carcasses and tissues (if applicable)
No
·
contaminated clothing (autoclaved / decontaminated prior to laundering)
Yes
·
gloves (i.e. disposed of in biological waste container)
·
pipettes and other glassware
·
equipment prior to removal from containment zone or services
a comment.
Is there an appropriate method for decontamination provided within the facility (e.g. incineration,
autoclaving)?
(Determine how contaminated items are treated. Can be processed in a central decontamination area
outside of facility if properly contained and transported.)
Yes
If your facility does not have access to an autoclave or other effective means of decontamination on-site,
Yes
are biohazardous wastes picked up for disposal by a certified waste disposal company?
No
No
Please specify
method(s)
used:
Please name
the company:
N/A
40
Are procedures in place for transporting waste securely to the decontamination area or off site to a
certified waste disposal company?
(Waste must be transported in properly labelled, leak-proof and impact resistant containers)
Click here to enter
No
a comment.
Yes
41
42
Are written procedures available for the decontamination methods used?
(Ask to review a copy of these documents)
No
Click here to enter
Yes
a comment.
Do you use an on-site autoclave for decontamination purposes?
Click here to enter
No
If no, skip to Q48.
a comment.
Yes
43
Is the autoclave equipped with a cycle log recorder?
(Examine one of the print outs of a run and check for sterilization, i.e. 121oC)
Click here to enter
No
a comment.
Yes
44
Are the autoclave cycle log recordings kept on file?
(Review these files)
Yes
Click here to enter
No
a comment.
N/A
45
Were the autoclave cycle(s) and other decontamination processes validated using representative loads
with appropriate biological indicators or thermocouples to ensure the parameters are effective?
Click here to enter
No
a comment.
Yes
46
Is the efficacy of the autoclave routinely monitored using biological indicators?
(Ask to see their indicators and how they conduct this testing)
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No
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Yes
a comment.
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Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
Questions
47
Are records of all validation studies and efficacy testing kept on file?
(Review these files)
48
49
Answers
Are work surfaces decontaminated regularly and at the end of each day?
(Ask to review the procedure; see if concentration and contact time are respected)
Are the disinfectants used for decontamination effective against the imported agent?
(Check to see which disinfectants are available)
No
Click here to enter
Yes
a comment.
No
Click here to enter
Yes
a comment.
No
Yes
8
50
52
53
54
55
56
Please specify
disinfectants
names and
concentrations
used:
General Operational Practices
Have traffic flow patterns from clean to dirty areas been established and adhered to?
(I.e. movement from least to most contaminated areas)
No
Yes
51
Comments
Are uniforms (lab coats, gowns, coveralls) worn and properly fastened when working in the containment
zone?
(Also applies to visitors and trainees)
Are the uniforms worn only in the containment zone?
(All dedicated clothing must be removed before exiting each containment zone. Check to see if anyone is
wearing lab coats in hallway, offices, cafeteria, library, etc.)
Is appropriate footwear worn in the containment zone?
(Employees must wear low-heel, closed heel and toe shoes, and preferably made of non-absorbent
material)
Is long hair tied back so that it cannot come into contact with hands, specimens or equipment?
(Check employee’s hair)
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
Yes
Click here to enter
No
a comment.
Are gloves worn when in direct contact with infectious materials (or infected animals)?
Are hands washed frequently: after handling infectious materials, after removing gloves, and before
leaving the containment zone?
(If you’ve touched anything in the lab, does staff make you wash your hands when you leave the area)
Click here to enter
N/A
57
In the containment zone, are personnel allowed to bring in personal belongings (such as hats, coats,
purses, etc.), eat, store food, chew gum, smoke or apply cosmetics?
Click here to enter
No
a comment.
Yes
58
Click here to enter
Are Good Microbiological Laboratory Practices employed to prevent the release of infectious agents?
No
Yes
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a comment.
Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
Questions
59
Is oral pipetting of any substance prohibited?
Answers
No
Yes
60
61
9
62
63
Is the use of needles, syringes and other sharp objects limited where possible?
Are open wounds, cuts, scratches and grazes covered with waterproof dressings?
Comments
Click here to enter
a comment.
No
Click here to enter
Yes
a comment.
No
Click here to enter
Yes
a comment.
Storage and Transport
Are infectious agents stored inside the containment zone?
(Agents stored outside the zone should be kept locked, in leak-proof containers)
Are leak-proof and impact-resistant containers used for the transport of infectious agents within facilities
(e.g., between laboratories in the same facility)?
No
Yes
If not, please
specify where
and how
material is
stored:
Click here to enter
Yes
a comment.
No
N/A
64
Is the transportation of infectious agents from the facility done in accordance and compliance with the
appropriate regulatory authority (e.g. Transport Canada’s Transportation of Dangerous Goods
Regulations)?
Yes
Click here to enter
No
a comment.
N/A
10
65
66
67
Recording and Reporting
Are records of activities carried out in the facility kept, including records of all building and equipment
maintenance, inspection reports prepared by the internal Biosafety Officer (BSO), decontamination of
packaging materials, etc?
(To be kept for a minimum of three years)
Are all spills, accidents and overt or potential exposures to infectious materials, as well as containment
failures, reported immediately to the laboratory supervisor, the BSO and the appropriate regulatory
authorities?
Are written records of such incidents kept and maintained?
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No
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Yes
a comment.
No
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Yes
a comment.
No
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Yes
a comment.
(09/2014)
Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
No
Questions
Answers
68
Are records kept of the imported animal pathogen? Records include (please specify):
Dates of importation / shipments received
Comments
No
Click here to enter
Yes
a comment.
CFIA Permits to Import
When / w here the animal pathogen w as used
Storage location
Date of disposal / w hen discarded.
(To be kept a minimum of three years for aquatic animal pathogens)
Note: This also applies to animal pathogen and other regulated material acquired through a Canadian
Distributor or by an authorized CFIA transfer.
69
Is further approval from CFIA requested prior to (please specify):
transf erring an animal pathogen to another containment zone not listed on the CFIA Permit to Import Animal
Pathogen;
Yes
No
transf erring an animal pathogen acquired v ia a Canadian Distributor to another containment zone; or
a comment.
N/A
if not already approv ed on the deliv ered import permit, introducing an imported animal pathogen into animals (in
v iv o use) or a dif f erent animal species.
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Inspection Checklist - Aquatic Animal Level 2 In Vitro Facilities
SECTION III: DECLARATION
I hereby declare that the information provided is complete, true and accurate to the best of my knowledge and
belief.
I agree to abide by the requirements outlined in the Containment Standards for Facilities Handling Aquatic
Animal Pathogens as well as any additional guidelines or conditions provided to me by the Office of Biohazard
Containment and Safety (OBCS), CFIA.
.
I will comply with all conditions specified on CFIA Importation Permit issued to our facility and to the conditions of
use and limitations provided to me by Canadian Distributors of material regulated by OBCS, CFIA.
I understant that failure to comply with the above may result in sanctions and possible
seizure of material regulated under the Health of Animals Act and its Regulations
Applicant
Name (Please print)
Signature
Inspection Date
.
Click here to enter a date
Biological Safety Officer
Name (Please print)
Signature
Inspection Date
.
Click here to enter a date
ONCE COMPLETED, PLEASE FORWARD (EMAIL, FAX OR MAIL) TO:
Animal Pathogen Importation Program
Office of Biohazard Containment & Safety
Canadian Food Inspection Agency
1400 Merivale Road, Ottawa ON K1A 0Y9
Phone: (613) 773-6520
Facsimile: (613) 773-6521
Email: ImportZoopath@inspection.gc.ca
Website: http://www.inspection.gc.ca/english/sci/bio/bioe.shtml
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