Completing the Containment Level 2 Checklist
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Public Health Agency of Canada Agence de la santé publique du Canada Completing the Containment Level 2 Checklist INTRODUCTION A Compliance Letter is issued when the information submitted by the applicant’s facilities has been reviewed by the Pathogen Regulation Directorate (PRD) (formerly the Office of Laboratory Security), Public Health Agency of Canada (PHAC), and is found acceptable and in accordance with the physical and operational requirements of the Laboratory Biosafety Guidelines, 3rd edition, 2004, as outlined in the Containment Level 2 (CL-2) Checklist. In order to obtain an Import Permit or Transfer letter from PRD, a Containment Level 2 checklist must be submitted along with an Application for Permit to Import Human Pathogens or transfer request, respectively. The Compliance Letter will also allow you to purchase risk group 2 pathogens from Canadian distributor companies. Completed CL-2 checklist and application forms may be submitted to the PRD by mail or fax. If the application is submitted by fax, please forward the original signed application by mail. NOTE: CL-2 checklists may be handwritten or typed. Handwritten forms must be legible. Illegible forms may delay the issuance of importation documents. If more space is needed for a question, you may attach additional information; please ensure that the question number is referenced in order to facilitate efficient review of the checklist. CONTAINMENT LEVEL 2 CHECKLIST REVIEW PROCESS A compliance letter will be issued once your CL-2 checklist has been reviewed by PRD and the information submitted is found acceptable. This letter will be faxed to you, with the original document to follow by regular mail. NOTE: Given that the normal review process takes 15-20 working days, we are not in a position to confirm the reception or comment about the status of a particular checklist. If the PRD does not contact you to obtain clarifications, it must be assumed that the application is complete and will be processed within 15-20 working days. Incomplete forms may delay the issuance of importation documents. If you have not received your documents on the 20th working day, you can contact the PRD to inquire about your application status. CL-2 checklists are specific to the facility supervisor, address and room. CL-2 checklists are valid for 1 or 2 years, depending on the presence of minor deficiencies, and are kept on file at the PRD; therefore, a new checklist does not have to be submitted with every new application. NOTE: If a CL-2 checklist has been previously submitted, you must clearly indicate this in block 7 of the Application for Permit to Import Human Pathogens. If your compliance letter includes a compliance letter number, this number should be indicated in block 7. Additionally, the room number(s) where the pathogens will be manipulated and/or stored must be indicated in block 8 of the Application for Permit to Import Human Pathogens, such that the information on the application and on the CL-2 checklist can be cross-referenced. NOTE: If you are a large institution with many CL-2 laboratories you may submit one checklist for a group of laboratories or all of your laboratories, if the application of the Laboratory Biosafety Guidelines, 3rd edition, 2004 is consistent throughout the laboratories. If the information provided in pages 1 and 2 of the Checklist is distinct for each lab (i.e. facility supervisor, program intent), you may submit multiple pages 1 and 2 along with only one copy of the reminder of the checklist. Public Health Agency of Canada Agence de la santé publique du Canada CONTACT INFORMATION When completed, fax your CL-2 checklist and/or application to 613-941-0596. or mail to: Pathogen Regulation Directorate, Centre for Emergency Preparedness and Response Public Health Agency of Canada, 100 Colonnade Road, Loc.: 6201A Ottawa, Ontario, K1A 0K9 Tel.: (613) 957-1779 INSTRUCTIONS FOR COMPLETING A CL-2 CHECKLIST PAGE 1. Complete all information and answer all questions. Provide your Human Pathogens and Toxins Act (HPTA) registration number. This number is indicated in red on your facility’s registration letter. For further information on HPTA registration contact your Biosafety Officer or visit http://www.phac-aspc.gc.ca/ols-bsl/pathogen/register-eng.php For the facility name, enter the complete name, including the department (if applicable). Do not use acronyms (i.e. PHAC instead or Public Health Agency of Canada). Enter a complete laboratory physical address. A PO Box number will not be accepted. If the postal address is different from the laboratory physical address, enter the appropriate information; otherwise simply select “same as laboratory physical address”. PAGE 2. Complete all information and answer all questions. The compliance letter will be issued to the Main Contact. This page must be signed by both contacts. The Facility Supervisor can be the same person as the Biosafety Officer. If this is the case, select “same as facility supervisor”. All questions in the CL-2 checklist are drawn directly from the PHAC Laboratory Biosafety Guidelines (LBGs). The LBGs should be consulted when further details are required. The LGBs are available online on the Pathogen Regulation Directorate Website at http://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.php PAGE 3 to 17. Answer all questions, unless otherwise indicated. When completing the checklist, some questions are marked "Mandatory". If you answer "No" to a “Mandatory” question, the answer must be clarified on page 17 of the CL-2 checklist. Failure to answer or clarify questions will increase the processing time. PAGE 13. Non-Human Primates If non-human primates are handled in the laboratory, please complete Annex A - Non-human Primates. This will be available on the PHAC-Pathogen Regulation Directorate website at http://www.phac-aspc.gc.ca/ols-bsl/pathogen/index-eng.php Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Physical and Operational Requirements in Accordance with the Laboratory Biosafety Guidelines, 3rd Edition, 2004 Facility Information Office use only File # : Human Pathogens and Toxins Act (HPTA) Registration Number*: RFacility Name: Room number(s) or name(s) where pathogen(s) will be manipulated and/or stored: Laboratory Physical Address (Not a Post Office Box): Mailing Address: Same as Laboratory Physical Address City: City: Province: Province: Postal Code: Postal Code: Type of Facility Government (Federal) University Private Government (Provincial) Hospital Other Program Intent – Brief description of the type of work and program objectives [research, diagnostic, production]. Scale/Volume Laboratory Comments Large Scale Other ___________________________________________ Pathogens used and/or stored Affecting humans : Comments Yes No Affecting animals/fish: Yes No * Your Human Pathogens and Toxins Act (HPTA) Registration Number is available on your HPTA Registration Letter. Consult your Biosafety Officer for further information. version 2.0 – 2010 Page 1 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist List of pathogens: (species and subtypes where applicable) Use of Animals: Yes No Species and Quantity: Contact Information Facility Supervisor (main contact†) Biosafety Officer (or equivalent) Name: Same as Facility Supervisor Name: Title: Title: Department: Department: Address: Address: Telephone: Telephone: Fax: Fax: Email: Email: Language Preference: English French Other Comments ______________________________________ Signature Language Preference: English French Other Comments __________ Date ______________________________________ Signature Compliance letters should be sent‡ to (select only one option): Main Contact; __________ Date Biosafety Officer † Note: compliance letters will be issued in the name of the Main Contact entered on this page. Note: compliance letters can be sent to either the Main Contact or the Biosafety Officer. If left blank or if both options are selected, the documents will be sent, by default, to the Main Contact. ‡ version 2.0 – 2010 Page 2 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist ALL MANDATORY QUESTIONS ANSWERED BY “NO” MUST BE CLARIFIED ON PAGE 17 Management of Biological Safety Q.1. (Chapter 2.3) Has the laboratory conducted a detailed risk assessment to determine whether the planned work requires Containment Level (CL) 1, 2, 3 or 4 facilities and operational practices? Q.2. (Chapter 2.4) Is a health and medical surveillance program in place? Note: For further details, refer to the Laboratory Biosafety Guidelines, Chapter 2.4. Q.3. (Chapter 2.5) Has a Biological Safety Officer been identified to specifically manage the facility's biological safety issues? RECOMMENDED Yes No MANDATORY Yes No MANDATORY Yes No Note: For further details, refer to the Laboratory Biosafety Guidelines, Chapter 2.5. Biosecurity Q.4. (Chapter 2.6) Is a biosecurity plan in place? Note: For further details, refer to the Laboratory Biosafety Guidelines, Chapter 2.6. Q.5. (Chapter 2.6) Is the biosecurity plan based on a detailed risk assessment? Note: For further details, refer to the Laboratory Biosafety Guidelines, Chapter 2.6. Q.6. (Chapter 2.6) Has a Responsible Officer (RO) been appointed to manage the biosecurity plan? MANDATORY Yes No MANDATORY Yes No RECOMMENDED Yes No Note: For further details, refer to the Laboratory Biosafety Guidelines, Chapter 2.6. Q.7. (Chapter 2.6) Are inventories updated regularly to include the addition (as a result of diagnosis, verification of proficiency testing, or receipt) and the removal of agents (after transfers or inactivation/disposal)? MANDATORY Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 3 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.8. (Chapter 2.6) Are the biosecurity plan and security practices regularly reviewed and updated to reflect new threats that may be identified? RECOMMENDED Yes No Handling Infectious Substances Q.9. (Chapter 3.1.1) Is the Standard Operating Procedures (SOP) manual available to all staff? MANDATORY Q.10. (Chapter 3.1.1) Are laboratory personnel required to follow these SOPs? MANDATORY Q.11. (Chapter 3.1.1) Is the SOP manual reviewed and updated regularly? Q.12. (Chapter 3.1.1) Is it forbidden to eat, drink, smoke, and store food, personal belongings, and/or utensils in the laboratory? MANDATORY Q.13. (Chapter 3.1.1) Is it forbidden to apply cosmetics or insert/remove contact lenses in the laboratory? MANDATORY Q.14. (Chapter 3.1.1) If contact lenses are permitted in the laboratory, is the use of protective eyewear required? Please check N/A if contact lenses are NOT permitted in the laboratory. MANDATORY Q.15. (Chapter 3.1.1) Is it forbidden to wear jewelry in the laboratory? Q.16. (Chapter 3.1.1) Is long hair tied back or restrained so that it cannot come into contact with hands, specimens, containers or equipment? Q.17. (Chapter 3.1.1) Are open wounds, cuts, scratches and/or grazes covered with waterproof dressings? Yes No Yes No MANDATORY Yes No Yes No Yes No Yes No N/A RECOMMENDED Yes No MANDATORY Yes No RECOMMENDED Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 4 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.18. (Chapter 3.1.1) Do personnel (including visitors, trainees and all others) wear protective laboratory clothing when entering/working in the laboratory? MANDATORY Q.19. (Chapter 3.1.1) Is suitable footwear with closed toes and heels worn in all laboratory areas? MANDATORY Q.20. (Chapter 3.1.1) Is eye and face protection used when there is a known/potential risk of exposure to splashes and/or flying objects? MANDATORY Q.21. (Chapter 3.1.1) Are gloves (e.g. latex, vinyl, co-polymer) worn for all procedures that might involve direct skin contact with biohazardous material or infected animals? MANDATORY Q.22. (Chapter 3.1.1) Are gloves removed before leaving the laboratory? MANDATORY Q.23. (Chapter 3.1.1) Is it forbidden to wear protective laboratory clothing in nonlaboratory areas? MANDATORY Q.24. (Chapter 3.1.1) If a known or suspected exposure occurs, is contaminated clothing decontaminated before laundering? MANDATORY Q.25. (Chapter 3.1.1) Is oral pipetting of any substance prohibited in the laboratory? MANDATORY Q.26. (Chapter 3.1.1) Is the use of needles, syringes and other sharp objects strictly limited? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No RECOMMENDED Yes No Note: when needles are used, it should be forbidden to bend, shear, recap or remove needles from the syringe. Q.27. (Chapter 3.1.1) Are hands washed: 1) after gloves have been removed, 2) before leaving the lab, and 3) after handling materials known/ suspected to be contaminated? MANDATORY Q.28. (Chapter 3.1.1) Is the laboratory kept clean and tidy? MANDATORY Q.29. (Chapter 3.1.1) Is an effective rodent and insect control program maintained? Yes No Yes No MANDATORY Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 5 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.30. (Chapter 3.1.2) Have the laboratory supervisors, in consultation with the Biological Safety Officer and/or Biosafety Committee, performed a risk assessment to determine which procedures and what concentrations and volumes necessitate the use of a BSC? RECOMMENDED Yes No Laboratory Design and Physical Requirements Q.31. (Chapter 4.1) Is the laboratory separated from public areas by a door? Q.32. (Chapter 3.1.1) Is access to the laboratory limited to authorized personnel only? MANDATORY Q.33. (Chapter 4.1) Do laboratory doors have appropriate signage (e.g. biohazard sign, containment level, contact information, entry requirements)? MANDATORY Q.34. (Chapter 4.1) Are door openings sized to allow passage of all anticipated equipment? MANDATORY Q.35. (Chapter 4.1) Is the door leading into the laboratory (or laboratory wing) lockable (or access controlled)? MANDATORY Q.36. (Chapter 3.1.1) Are laboratory doors kept closed at all times? MANDATORY MANDATORY Yes No Note: this does not apply to an open area within a laboratory. Yes No Yes No Yes No Yes No Yes No Q.37. (Chapter 4.1) Are office areas located outside of the containment laboratory? RECOMMENDED Q.38. (Chapter 3.1.1) Are paperwork and report writing areas kept separate from areas where biohazardous materials are manipulated? RECOMMENDED Q.39. (Chapter 4.2) Are doors, frames and casework non absorptive (e.g. the use of organic materials should be avoided)? RECOMMENDED Q.40. (Chapter 4.2) Are working surfaces of bench tops non-absorptive? Yes No Yes No Yes No MANDATORY Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 6 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.41. (Chapter 3.1.1) Are work surfaces that have become permeable to biohazardous material (e.g. cracked, chipped, loose) replaced or repaired as soon as possible? MANDATORY Q.42. (Chapter 4.2) Are surfaces scratch, stain, moisture, chemical and heat resistant in accordance with laboratory function? MANDATORY Q.43. (Chapter 4.2) Are interior coatings resistant to gas and chemical in accordance with laboratory function (e.g. will withstand chemical disinfection, fumigation)? MANDATORY Q.44. (Chapter 4.4) If windows are present in the laboratory, are they equipped with screens? Answer N/A if no windows in the laboratory or if sealed. MANDATORY Q.45. (Chapter 4.5) Is there a mechanism to hang laboratory coats near the laboratory exit? MANDATORY Q.46. (Chapter 4.5) Are street clothing and laboratory clothing (lab coats) areas physically separated? MANDATORY Q.47. (Chapter 4.5) Are handwashing sinks located near the laboratory exit? MANDATORY Q.48. (Chapter 4.5) Are handwashing sinks provided with “hands-free” capability? Q.49. (Chapter 4.5) Is an emergency eyewash station available inside, or in proximity of the laboratory? MANDATORY Q.50. (Chapter 4.5) Is an emergency shower available inside, or in proximity of, the laboratory? MANDATORY Yes No Yes No Yes No Yes No N/A Yes No Yes No Yes No RECOMMENDED Yes No Yes No Yes No If no BSCs are available to the laboratory: All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 7 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.51. (Chapter 3.1) Are operational practices and techniques § used to minimize the creation of aerosols? MANDATORY Yes No Note: if no BSCs are available, proceed to Q63. Biological Safety Cabinets (BSCs) If BSCs are available to the laboratory: Q.52. (Chapter 9.3) Are BSCs certified (after installation, annually and after any repair/relocation) in accordance with the requirements outlined in National Sanitation Foundation NSF/ANSI 492004a: NSF 49 Class II (Laminar Flow) Biosafety Cabinetry? RECOMMENDED Yes No Note: the Canadian Standards Association CSA Z316.3 Biological Containment Cabinets (Class I and II): Installation and Field Testing was withdrawn by CSA and replaced with the NSF/ANSI 49 standard. Q.53. (Chapter 9.3) Is the on-site BSC certification performed by experienced qualified individuals? MANDATORY Q.54. (Chapter 9.3) Following the BSC certification testing, is a copy of the certification report provided to the laboratory supervisor and kept on file? MANDATORY Q.55. (Chapter 9.3) Are BSCs located away from high traffic areas, doors and air supply/exhaust grilles that may interrupt airflow patterns? Q.56. (Chapter 3.1.2) Are BSCs used, or would they be used, for procedures that may produce infectious aerosols?** Yes No Yes No RECOMMENDED Yes No MANDATORY Yes No § Procedures which may produce aerosols include: pipetting, spills and splashes, loading needles, discharge from animals or ectoparasites, operation of a centrifuge, homogenization, plating cultures. Operational practices and techniques used to control the production of aerosols include but are not limited to: emptying of pipette down side of tube, use of cooled or disposable loops to plate culture, use of lab-grade blender or homogenizer, use of sealed safety cups and rotors with centrifuge. ** Please see note above. All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 8 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.57. (Chapter 3.1.2) Are BSCs used, or would they be used, for procedures that involve high concentrations of biohazardous material? MANDATORY Q.58. (Chapter 3.1.2) Are BSCs used, or would they be used, for procedures that involve large volumes of biohazardous material? MANDATORY Q.59. (Chapter 9.4) Does the SOP require that before working in the BSC, employees must: 1) turn off the UV lights (if in use), 2) verify the correct position of the sash, 3) verify that the air grilles are free from obstructions, 4) verify the inward airflow (by gauge readings, or by holding a tissue to make sure that it is drawn in), and 5) disinfect all interior surfaces of the BSC? MANDATORY Q.60. (Chapter 9.4) Does the SOP require that while working in the BSC, employees must: 1) avoid excessive movement of hands and arms through the front access opening, 2) keep contaminated materials to the rear of the cabinet, and 3) ensure to always discard materials in containers inside the BSC? MANDATORY Q.61. (Chapter 9.4) Does the SOP require that while working in the BSC, employees must avoid the use of open flames (e.g. bunsen burner)? MANDATORY Q.62. (Chapter 9.4) Does the SOP require that upon completion of work in the BSC, employees must: 1) allow the BSC to run for 5 minutes with no activity, 2) ensure all containers are closed/covered before removing from BSC, 3) ensure that all contaminated objects/materials are disinfected before removing from BSC, 4) disinfect working areas of the BSC while it is still in operation, and 5) remove and dispose gloves inside the BSC? Yes No Yes No Yes No Yes No Yes No RECOMMENDED Yes No Decontamination and Disposal of Biohazardous Waste Q.63. (Chapter 3.1.1) Are all contaminated materials, solid or liquid, decontaminated before disposal, reuse or removal from the laboratory, or laboratory wing if a centralized decontamination room is used? MANDATORY Q.64. (Chapter 3.1.1) Are contaminated materials, solid or liquid, contained in such a way as to prevent the release of the contaminated contents if removed from the laboratory? MANDATORY Q.65. (Chapter 8.1) Do laboratory workers use effective products for the decontamination of: equipment, samples, surfaces and spills of infectious materials? MANDATORY Yes No Yes No Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 9 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.66. (Chapter8.1) Are laboratory bench tops and surfaces decontaminated at the end of the working day? MANDATORY Q.67. (Chapter 8.1) Are laboratory bench tops and surfaces decontaminated after any spill of infectious materials? MANDATORY Q.68. (Chapter 8.1) Are specific protocols in place for the decontamination of laboratory rooms and large pieces of equipment? MANDATORY Q.69. (Chapter 3.1.1) Are contaminated materials and equipment leaving the laboratory for servicing or disposal being appropriately decontaminated and labeled as such? MANDATORY Q.70. (Chapter 3.1.1) Are disinfectants effective against the agents in use available at all times within the areas where the biohazardous material is handled or stored? MANDATORY Q.71. (Chapter 8.2) Is there an autoclave in the laboratory, or does the laboratory have access to an autoclave in proximity of the laboratory? RECOMMENDED Yes No Yes No Yes No Yes No Yes No Yes No Note: if no autoclave is available, please proceed to Q76. Q.72. (Chapter 8.2) Are effective operating parameters for the autoclave established by developing standard loads and their processing times (with the use of biological indicators)? Q.73. (Chapter 3.1.1) Is efficacy monitoring of autoclaves with biological indicators done regularly (e.g. consider weekly, depending on the frequency of use of the autoclave)? MANDATORY Q.74. (Chapter 8.2) Are appropriate biological indicators selected and used? MANDATORY Note: resistance of test organism must be representative of organisms likely to be encountered. RECOMMENDED Yes No Yes No Yes No Q.75. (Chapter 3.1.1) Are the results of the autoclave efficacy monitoring and cycle logs (e.g. time, temperature and pressure) kept on file? MANDATORY Q.76. (Chapter 3.1.1) If the laboratory does not have access to an autoclave, is biohazardous waste picked up for disposal by a specialized company? Company Name: MANDATORY Yes No Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 10 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.77. (Chapter 3.1.1) Are needles, syringes and other sharp objects disposed in a puncture-resistant sharps container? MANDATORY Yes No Spills, Incidents and Emergencies Q.78. (Chapter 3.1.2) Are emergency procedures for spill clean-up, BSC failure, fire, animal escape and other emergencies written, easily accessible and followed? MANDATORY Q.79. (Chapter 3.1.2) In the event of an emergency, does your emergency procedure require a record to be made of other people (e.g. emergency responders) entering the facility? MANDATORY Q.80. (Chapter 3.1.1) Are spills, accidents or exposures to infectious materials and losses of containment (e.g. BSC failure) reported immediately to the laboratory supervisor? MANDATORY Q.81. (Chapter 3.1.1) Are written records of spills, accidents or exposures to infectious materials and losses of containment kept on file? MANDATORY Q.82. (Chapter 3.1.1) Are the results of incident investigations of spills, accidents or exposures to infectious materials and losses of containment used for continuing education? RECOMMENDED Yes No Yes No Yes No Yes No Yes No Training Q.83. (Chapter 3.1.1) Have personnel received training on the potential hazards associated with the work involved, and on the necessary precautions to prevent potential exposure to infectious agents and the release of infectious material? MANDATORY Q.84. (Chapter 3.1.2) Have all people working in the containment area been trained in and follow the operational protocols for the project in process? MANDATORY Yes No Yes No Note: when in the laboratory, trainees must always be accompanied by a trained staff member. All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 11 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.85. (Chapter 2.6) Have all people working in the containment area been trained in the biosecurity plan? MANDATORY Yes No Note: training must include response to biosecurity incidents and emergencies. Q.86. (Chapter 3.1.1) Are training records, showing that personnel have understood the training, kept on file? MANDATORY Yes No Note: training records must be signed by both the employee and the laboratory supervisor. Q.87. (Chapter 3.1.1) Has the laboratory implemented regular retraining programs? Q.88. (Chapter 9.1) Is every employee working in a BSC trained in its correct use and have a good understanding of the different types of cabinets and how they work? Answer N/A if no BSC are available. MANDATORY Q.89. (Chapter 8.1) Are employees trained in all decontamination procedures specific to their activities? MANDATORY Q.90. (Chapter 3.1.2) Are visitors, maintenance staff, janitorial staff and others, as deemed appropriate, provided with training and/or supervision with regards to their anticipated activities in the laboratory? MANDATORY MANDATORY Yes No Yes No N/A Yes No Yes No Regulatory Aspects for Handling Infectious Substances Q.91. (Chapter 10.1) If the facility was to import a human pathogen requiring CL2, would the facility always ensure to have a valid importation permit from the Public Health Agency of Canada (PHAC)? MANDATORY Yes No Note: pathogens that are common to both humans and animals also require an importation permit from the Canadian Food Inspection Agency (CFIA). Q.92. (Chapter 10.2) Q.93. (Chapter 10.3) Does, or would, the laboratory obtain further approval from PHAC before transferring an agent that was brought into Canada under an import permit that restricts its distribution to another location? Are all individuals transporting (shipping and/or receiving) an infectious substance trained in the transportation of dangerous goods as required by Transport Canada's regulations? MANDATORY Yes No MANDATORY Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 12 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.94. (Chapter 3.1.1) Are leak-proof containers used for the transport of infectious materials within facilities (e.g. between laboratories in the same facility)? MANDATORY Yes No Animal Facilities Q.95. (Chapter 7.1.1) Are animals handled in the laboratory? Note: if no, proceed to Q105. MANDATORY Yes No Q.96. (Chapter 7.1.1) Is the laboratory designed and operated in accordance with: 1) the Containment Standards for Veterinary Facilities, published by CFIA, and 2) the Guide to the Care and Use of Experimental Animals and all other guidelines and policies (as revised from time to time) published by the Canadian Council on Animal Care (CCAC)? MANDATORY Q.97. (Chapter 7.1.1) If using animals for research, teaching and testing does the institution have a CCAC Certificate of GAP (Good Animal Practice®)? RECOMMENDED Q.98. (Chapter 7.1.1) Are the animal facilities a physically separated unit from the laboratory? MANDATORY Q.99. (Chapter 7.1.1) If animal facilities adjoin the laboratory, are the animal rooms separated from other activities in the laboratory to allow for isolation and decontamination as required? MANDATORY Q.100. (Chapter 7.1.1) Are the animal rooms designed with a small preparation area, a storage area and a handwashing sink? MANDATORY Q.101. (Chapter 7.1.1) Since general protocols cannot anticipate the specific requirements of each experiment, are specific entry and exit protocols for scientific staff, animal handlers, animals, biological samples, equipment, feed and wastes developed for each project? MANDATORY Yes No Yes No Yes No Yes No Yes No Yes No All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 13 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.102. (Chapter 7.1.1) Does staff use extra protective clothing and equipment when entering an animal cubicle contaminated with large volumes of infected animal waste? Please check N/A if the facility does not have large animal cubicles. MANDATORY Q.103. (Chapter 7.1.1) Are physical barriers, restraints and/or gating systems used when staff is required to handle large animals? Please check N/A if the facility does not handle large animals. MANDATORY Q.104. (Chapter 7.1.1) Are handlers informed of the animals' general characteristics (e.g. mentality, instincts and physical attributes) before starting work with animals? MANDATORY Yes No N/A Yes No N/A Yes No Non-human Primates Q.105. (Chapter 7.1.2) Are non-human primates handled in the laboratory? Note: if no, proceed to Q106. If yes, complete Annex ANon-human Primates available online from: http://www.phacaspc.gc.ca/ols-bsl/index-eng.php MANDATORY Yes No Recombinants and Genetic Manipulations Q.106. (Chapter 7.2) Are recombinants manipulated in the laboratory? Note: if no, proceed to Q111. Q.107. (Chapter 7.2) Before recombinants are to be manipulated in the laboratory, is a detailed risk assessment performed to determine the containment level requirements? MANDATORY Yes No MANDATORY Yes No Note: Risk assessment must consider: 1) the containment level of the recipient organism, 2) the containment level of the donor organism, 3) the replication competency of the recombinant organism, 4) the property of the donor protein to become incorporated into the recombinant particle, and 5) potential pathogenic factors associated with the donor protein. All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 14 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.108. (Chapter 7.2) Are all recombinants handled at the required containment level as determined by the risk assessment? MANDATORY Q.109. (Chapter 7.2) If one of the components of the reaction is hazardous, are the containment level requirements appropriate to the known hazard (at a minimum)? MANDATORY Q.110. (Chapter 7.2) Are host vector systems, with limited ability to survive outside the laboratory, used in research with genes coding for hazardous products? MANDATORY Yes No Yes No Yes No Cell Culture Q.111. (Chapter 7.3.1) Are cell lines manipulated in the laboratory? Note: if no, proceed to Q116. Q.112. (Chapter 7.3.1) Before a new cell line is to be manipulated in the laboratory, is a detailed risk assessment performed to determine the containment level requirements? MANDATORY Yes No MANDATORY Yes No Note: Risk assessment must consider: 1) source of cell line, 2) source of tissue, 3) type of cell line, 4) quantity of cells per culture, 5) source population, 6) properties of the host cell line, 7) vector used for transformation, 8) transfer of viral sequences, 9) transfer of virulence factors, 10) activation of endogenous viruses, 11) recombinant gene product, and 12) presence of helper virus. Q.113. (Chapter 7.3.2) Are all cell lines handled at the required containment level as determined by the risk assessment? MANDATORY Q.114. (Chapter 7.3.2) Are all cell lines with known/potential viral contaminants handled at the containment level required for the contaminating agent of higher risk? MANDATORY Q.115. (Chapter 7.3.2) Are all manipulations that may alter the "normal" behavior of cell lines to a more hazardous state†† conducted at the containment level required for the new hazardous state? MANDATORY Yes No Yes No Yes No †† Cell lines can be grown in an altered manner by applying various treatments (e.g., change in pH, serum level, temperature, medium supplements, co-cultivation). All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 15 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Q.116. (Chapter 7.3.2) Are Macaca tissues handled in the laboratory? Note: if no, proceed to Q118. MANDATORY Yes No Q.117. (Chapter 7.3.2) If Macaca tissues are manipulated in the laboratory, are manipulations performed as follows: 1) CL2 facility with CL3 operational protocols when handling tissues or body fluids, 2) CL3 facility for material that is suspected/known to contain herpesvirus simiae, 3) CL3 facility for in vitro primary diagnostic tests; 4) CL4 facility for propagation and culture of herpesvirus simiae. MANDATORY Q.118. (Chapter 7.3.2) Are cell cultures derived from bovine sources known/suspected to be BSE positive manipulated in the laboratory? MANDATORY Yes No Yes No Note: if no, proceed to Q120. Q.119. (Chapter 7.3.2) If cell cultures derived from bovine sources known/suspected to be BSE positive are manipulated in the laboratory, are the requirements of the Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents, published by CFIA, followed? MANDATORY Yes No Note: this includes the in vitro primary diagnostic tests of cell cultures. Q.120. (Chapter 7.3.3) Are all self-self experiments prohibited?‡‡ Note: self-self experiments involve biological products derived from the individual performing the experiment. MANDATORY Yes No ‡‡ Procedures or experiments with transformed human cells derived from the individual (human autologous) manipulating the cells is prohibited. Such experiments put the individual at risk, since any immune protection that is normally available to destroy foreign cells is now bypassed. All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 16 of 17 Public Health Agency of Canada Agence de la santé publique du Canada Containment Level 2 Checklist Clarifications to Mandatory Questions Answered by “No” Question # Clarification NB: If more space is required, please attach another page with additional clarifications. Internal Use Only SUMMARY AND COMMENTS: REVIEWED BY: DATE: _____________________________________________________________ ______________________________________ Send your completed CL-2 checklist by fax or mail at: Pathogen Regulation Directorate (formerly Office of Laboratory Security) Public Health Agency of Canada 100 Colonnade Rd., Ottawa, Ontario, Canada, K1A 0K9 Tel: (613) 946-6982, Fax: (613) 941-0596 All mandatory questions answered by “No” must be clarified on page on p.17 version 2.0 – 2010 Page 17 of 17
