Inspection Checklist - Animal Pathogen Containment Level 2 Facilities

PDF (135 kb)

Company/Organization:

Building(s) / Room(s) # where material will be handled:

Applicant's Name:	Biological Safety Officer's name:
Address:	Address:
Phone:	Phone:
Fax:	Fax:
Email:	Email:

SECTION I: LABORATORY

1- Biological Safety

Item	Reference to Standard*	Questions	Answers	Comments
Biological Safety Officer		Is there a Biological Safety Officer or individual responsible for biological safety? (this individual should be present during the inspection)	Yes No N/A
		Is there a copy of the Containment Standards for Veterinary Facilities*, which apply to all laboratories importing and working with pathogens infectious to animals, available to containment zone** staff? (a copy must be available and staff must have read this document)	Yes No N/A
Safety Manual	Section 6.1 (p. 45)	Is there a laboratory procedural or safety manual?	Yes No N/A
Emergency Procedures	Section 6.1 (p. 46)	Are there written emergency procedures for spill clean-up, BSC failure, power failure, animal escape (if applicable), fire, and other emergencies? (review a copy of these procedures)	Yes No N/A

* The page numbers referenced in this checklist correspond to the page numbers found in the hard copy titled Containment Standards for Veterinary Facilities, 1st Edition, July 1996. Agriculture & Agri-Food Canada Publication No. 1921/E.

** In this section, the expression "Containment zone" is used merely to simplify the text; it refers to laboratory room(s) and/or animal facility(ies) where the animal pathogen will be used.

2 - Training

Item	Reference to Standard	Questions	Answers	Comments
Training	Section 6.1 (p. 45)	Have containment zone staff read and understood the safety manual? (ask a staff member if they read the manual)	Yes No N/A
	Section 6.1 (p. 45)	Do all persons in the containment zone know and follow the operational protocols for the projects in process?	Yes No N/A
		Does employee training include the review of Material Safety Data Sheets (MSDS)*** 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 MSDS)	Yes No N/A
	Section 6.1 (p. 45)	Is there written documentation of the training provided? (review this documentation, it must describe the training provided and has to be signed by the both the employee and the supervisor)	Yes No N/A
		Are the employees (i.e. researchers and/or technicians) working in the containment zone responsible for housekeeping?	Yes No N/A
	Section 6.1 (p. 45)	Are non-laboratory staff (i.e. janitors, maintenance workers, contractors, visitors) entering the containment zone trained in the hazards associated with the imported material? (review the training given / visitor's policy)	Yes No N/A

*** Several MSDS can be found on the CFIA or PHAC website, at http://www.inspection.gc.ca/english/sci/bio/anima/disemala/disemalae.shtml and http://www.phac-aspc.gc.ca/msds-ftss/index-eng.php respectively.

3 - Physical Requirements

Item	Reference to Standard	Questions	Answers	Comments
Access	Sections 3.1, 3.2 and 3.3 (p. 6, 17, 26)	Is access to the laboratory area restricted to persons on official business? (determine how - locks and/or signs)	Yes No N/A
Signs	Sections 3.1, 3.2 and 3.3 (p. 6, 17, 26)	Are biohazard signs posted on the containment zone doors warning of the agents in use; and entry requirements, if applicable?	Yes No N/A
	Sections 3.1, 3.2 and 3.3 (p. 6, 17, 26)	Do the signs list the name and phone number of the person to contact in case of emergency?	Yes No N/A
Offices	Sections 3.1, 3.2 and 3.3 (p. 6, 17, 26)	Are office areas located outside of working areas? (paperwork stations are permitted within the areas)	Yes No N/A
	Sections 3.1, 3.2, 3.3 and 6.2 (p. 7, 16, 26, and 47)	Are the paperwork stations (and reference material area) in the containment zone located away from hazardous materials?	Yes No N/A
Surface Finishes	Section 3.1 (p. 8)	Are the floors slip-resistant?	Yes No N/A
	Section 3.5 (p. 37)	Are surfaces in the rooms scratch, stain, moisture, chemical and heat resistant; in accordance with function? (they should be in good condition, cleanable and resistant to disinfection)	Yes No N/A
General Condition	Section 6.2 (p. 47)	Are the rooms kept neat, orderly and clean?	Yes No N/A
Perimeter	Sections 3.1, 3.2 and 3.3 (p. 8, 19, 30)	Are doors and windows to the containment zone kept closed? (check to make sure there they are all closed, doorstop shouldn't be present)	Yes No N/A
Air Handling System	Sections 3.1, 3.2 and 3.3 (p. 10, 20, 31)	Does the containment zone have inward directional airflow? (check this at doorway using a smoke pencil or tissue)	Yes No N/A
	Sections 3.1 and 5.2 (p. 10, 43)	Does the HVAC system (heating, ventilation, air conditioning) interfere with the airflows of biological safety cabinets? (check to make sure cabinets are not located directly under a supply diffuser)	Yes No N/A
Biological Safety Cabinets (BSC)	Sections 5.0 and 6.2 (p. 41, 48)	Are BSCs used for aerosol generating procedures and with high concentration or large volumes of infectious materials? (work with level 2 agents on the bench is permitted - supervisor must assess which procedures to be done in BSC)	Yes No N/A
	Section 5.0 (p. 41)	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)	Yes No N/A
	Section 5.2 (p. 44)	Are BSCs certified in accordance with NSF/ANSI 49 Class II (LaminarFlow) Biohazard Cabinetry at least annually? (check for certification sticker - some BSCs needs to be certified according to manufacturer specifications)	Yes No N/A
	Section 5.2 (p. 44)	Does the certification sticker indicate the date of next certification, to what standards the tests were performed and the name of the certifier?	Yes No N/A
	Section 5.2 (p. 44)	Is a copy of the certification report readily available? (ask to see a copy of the report)	Yes No N/A
Laboratory Services	Section 3.1 (p. 12)	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)	Yes No N/A
	Sections 3.1, 3.2 and 3.3 (p. 14, 24, 34)	Are life-safety systems, lighting, and essential equipment supported by normal emergency power?	Yes No N/A
	Sections 3.1, 3.2 and 3.3 (p. 22, 33, 38)	Are hand washing sinks provided in the containment zone? (check to see if the sinks are of hands-free operation, should be dedicated to this use only)	Yes No N/A
Pest Program	Sections 3.1, 3.2, 3.3 and 6.1 (p. 9, 20, 30, and 46)	Is the facility proofed against vermin and insects? (do they have a exterminator contract; check for dead flies and mouse droppings)	Yes No N/A

4 - Decontamination

Item	Reference to Standard	Questions	Answers	Comments
Decontamination	Section 6.2 (p. 48)	Are all contaminated materials decontaminated before disposal, reuse or removal from the containment zone? (includes solid & liquid wastes, contaminated clothing, gloves, equipments, etc.)	Yes No N/A
	Sections 3.1, 3.2 and 3.3 (p. 9, 19, 30)	Is there an appropriate method for decontamination provided in the facility (e.g. incinerator, autoclave)? (determine how contaminated items are treated - can be processed in a central decontamination area outside of facility if properly contained and transported.)	Yes No N/A	Please specify which method(s) used
		If the facility does not have access to an autoclave or other effective means of decontamination, are biohazardous wastes picked up for disposal by a specialized company?	Yes No N/A	Please name the company (if applicable)
	Section 6.5 (p. 60)	Are written procedures available for the decontamination methods used? (ask to review a copy of these documents)	Yes No N/A
Autoclaves	Section 3.1 (p. 9)	Is the autoclave located in the laboratory zone? (can be located in a central decontamination area for the facility)	Yes No N/A
	Section 3.1 (p. 9)	Is the autoclave equipped with a cycle log recorder? (examine one of the print outs of a run and check for sterilization, i.e. 121°C)	Yes No N/A
	Sections 6.2 and 6.5 (p. 48, 61)	Are the autoclave cycle log recordings kept on file? (review these files)	Yes No N/A
	Sections 6.2 and 6.5 (p. 48, 61)	Is the efficacy of the autoclave monitored using biological indicators? (ask to see their indicators and how they conduct this testing)	Yes No N/A
	Sections 6.2 and 6.5 (p. 48, 61)	Are records of the efficacy testing kept on file? (review these files)	Yes No N/A
Work surfaces	Section 6.2 (p. 48)	Are contaminated work surfaces decontaminated at the end of the day? (ask to review the procedure; see if contact time is respected)	Yes No N/A
	Section 6.5 (p. 61)	Are the disinfectants used for decontamination effective against the imported agent? (check to see which disinfectants are available)	Yes No N/A	Please specify which disinfectants and concentrations used

5 - Operational Practices

Item	Reference to Standard	Questions	Answers	Comments
Uniforms	Section 6.2 (p. 47)	Are uniforms (lab coats, gowns, coveralls) worn when working in the containment zone?	Yes No N/A
	Section 6.2 (p. 47)	Are the lab coats worn only in the laboratory areas? (check to see if anyone is wearing lab coats in offices, cafeteria, library)	Yes No N/A
Gloves	Section 6.2 (p. 47)	Are gloves worn when directly contacting the imported infectious materials (or infected animals)?
	Section 6.2 (p. 48)	Are gloves decontaminated before disposal? (check to ensure no gloves are disposed of in regular garbage)	Yes No N/A
Handwashing	Section 6.2 (p. 47)	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)	Yes No N/A
Footwear	Section 6.2 (p. 47)	Is appropriate footwear worn in the containment zone? (employees must wear low-heel, closed heel and closed toe shoes. Preferably, they should be made of non-absorbent material)	Yes No N/A
Hair	Section 6.2 (p. 47)	Is long hair tied back so that it cannot come into contact with hands, specimens and equipment? (check employee's hair)	Yes No N/A
Eating and others	Section 6.2 (p. 47)	Is eating, chewing gum, smoking, storing food and applying cosmetics allowed? (check the fridge for food)	Yes No N/A
Storage	Section 6.2 (p. 48)	Are infectious agents stored inside the containment zone? (infectious agents stored outside the zone should be kept locked, in leakproof containers)	Yes No N/A

6 - Records

Item	Reference to Standard	Questions	Answers	Comments
Records	Section 6.2 (p. 47)	Are there records kept of the imported pathogen? (review these records)	Yes No N/A
	Section 6.2 (p. 47)	Do the records indicate where the pathogen was used/stored and the date of disposal? (trace an imported pathogen through the record system from receipt to disposal)	Yes No N/A

SECTION II: IN VIVO WORK

Do you intend to use an animal pathogen for work with animals:

• Yes, please complete the following additional questions.
• No, please go directly to Section III, page 7.

7 - Animal Facilities - Physical Requirements
Please list the room number(s) which apply to this section (where animals are held):

Item	Reference to Standard	Questions	Answers	Comments
Animal rooms		What animals are housed in this animal facility?	Small animals Large animals Aquatic animals	Please list the different animal species used
Access	Sections 3.2 and 3.3 (p. 17, 26)	Is the entry and exit area for personnel provided via ventilated airlock? (ventilation provided through leaky doors and/or HVAC systems)	Yes No N/A
	Sections 3.2 and 3.3 (p. 18, 27)	Is the entry and exit area for personnel provided with a clothing change area?	Yes No N/A
	Section 3.2 (p. 18)	Is the entry area for animals provided via ventilated airlock? (ventilation provided through leaky doors)	Yes No N/A
Office	Sections 3.2 and 3.3 (p. 16, 25, 26)	Are office areas located outside of animal facility working areas? (paperwork stations must be located outside of the animal rooms)	Yes No N/A
Storage	Sections 3.2 and 3.3 (p. 16, 26)	Are adequate feed and bedding storage areas provided within the containment zone?	Yes No N/A
Surface Finishes	Sections 3.2 and 3.3 (p. 19, 29)	Are the floors slip-resistant, cleanable, and comprising a slope towards floor drains?	Yes No N/A
	Sections 3.2 and 3.3 (p. 18, 19, 29, and 30)	Are the interior surfaces (coatings) continuous, impact resistant and minimize the movement of gases and liquids through the perimeter membrane, in accordance with function?	Yes No N/A
	Sections 3.2 and 3.3 (p. 19, 30)	Are doors and frames of animal rooms of non-absorptive material, have solid finishes, or sealed? (wood is not acceptable)	Yes No N/A
Small animals - General	Section 3.2 (p. 16)	Is a clean and dirty cage washing area provided in the containment zone? (if not, determine how cages are cleaned)	Yes No N/A
Small Animals - Primary Containment Devices	Section 6.3 (p. 53)	Are containment caging systems used? (this is optional at level 2 but some facilities may use them)	Yes No N/A
Experimental Areas / Post Mortem Room	Sections 3.2 and 3.3 (p. 16, 26)	Are experimental areas (i.e. for necropsy, surgical procedures) provided and separated from animal rooms? (for large animal facility, a Post Mortem room should be available)	Yes No N/A
Laboratory Services	Sections 3.2 and 3.3 (p. 22, 33)	Are hands-free hand washing sinks provided in the animal facility?	Yes No N/A

 

8 - Animal Facilities - Operational Practices

Item	Reference to Standard	Questions	Answers	Comments
Uniforms	Section 6.3 (p. 52)	Are coveralls and dedicated footwear worn when working in the animal facility? (or other equivalent clothing)	Yes No N/A
	Section 6.3 (p. 53)	Are appropriate methods for protective clothing in place for work in each animal room? (i.e. do they use disinfectant footbaths or change clothing between animal rooms?)	Yes No N/A
	Section 6.3 (p. 52)	Are respirators worn when handling potentially zoonotic agents than cannot be contained in primary containment devices?	Yes No N/A

SECTION III: ANIMAL PATHOGENS USED

Please check the product(s) handled in your laboratory:

Please list the organisms or biological material routinely used:

SECTION IV: DECLARATION

I hereby declare that the information given above 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 Veterinary Facilities as well as any additional guidelines or conditions provided to me by the Office of Biohazard Containment and Safety, CFIA.

I understand that failure to comply with the above may result in sanctions and possible seizure of material regulated under the Health of Animal Acts and its Regulations.

 

 

ONCE COMPLETED, PLEASE FORWARD (EMAIL, FAX, OR MAIL) TO:
Canadian Food Inspection Agency
Office of Biohazard Containment and Safety
Animal Pathogen Importation Program
1400 Merivale Road, Ottawa ON K1A 0Y9
Phone: 613-773-6520
Facsimile: 613-773-6521
Email: importzoopath@inspection.gc.ca