The Current CL2 Checklist is New and Requires Documentation

The current CL2 checklist was published only recently (July 2013) in response to the release of the new Canadian Biosafety Standards and Guidelines (CBSG). The CBSG is an update and combination of the following biosafety standards and guidelines for human and terrestrial animal pathogens:

• Laboratory Biosafety Guidelines 3rd Edition, 2004 (PHAC)
• Containment Standards for Veterinary Facilities 1st Edition, 1996 (CFIA)
• Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents, 2005 (CFIA)

The CL2 checklist is used as a tool to evaluate the compliance of a facility and its workers to the CBSG standards which allow them to safely handle risk group 2 pathogens. The audit of the laboratory is carried out by the Biosafety Auditor (Carol Carte) and the PI. You will find that there are many documents that must be in place, including but not limited to, general SOPs, emergency procedures and training records. These are in addition to the lab-specific experimental "protocols" which most workers keep for themselves. A tip for document organization is found here.

For those who have previously completed PHAC and/or CFIA CL2 checklists or the combined CL2 checklist, you may have recieved via email a "supplemental" CL2 checklist. This supplemental checklist, when submitted, essentially fills the gaps in the lab audit such that all elements of the new CBSG are captured.

The PDF CL2 Checklist Form

The form is found on our website here and is in PDF format. The format has embedded macros which carry out different functions. For example, if you click certain options, questions will disappear from the form since they are not relevant to your choices - therefore some of the hints below, will not be relevant to your particular application. Also, once the form is completed, you must validate the form before printing. Validating the form creates an internal check to ensure that all questions are answered and in the case of explanatory notes, it ensures that if required, text is present. The validate and print button is at the top of the form.

Starting The Application

When you first open the application, you will notice it is only one page. However when you click the button at the bottom of the first page to continue, the rest of the application appears. It is 25 pages in length.

Below are explanations of the questions asked in the checklist for CL2 only. Documents which must be created by the laboratory and which will be audited are in red text. No explanation exists if the question is self-explanatory.

THIS SECTION IS UNDER CONSTRUCTION

Facility Information

Facility Name: McMaster University

Department: Your department

Facility Classification: CL2 only (includes BSL2 and small animals), CL2-AG (BSL2 large animal facility), CL2 and CL2-Ag (BSL2 facility and BSL2 large animal facility); most McMaster BSL2 labs are CL2 only. Contact the Biosafety Office if you are CL2-AG or CL2 and CL2-AG.

Type of Facility: Academic

Program Intent: check all that apply

Descripton of Program Intent: A short description of your work. How do you use your RG2 pathogens? In vitro, in vivo? Both?

Pathogen/Toxin Information

Pathogens/Toxins Handled/Stored: check all that apply

Type of Material Handled/Stored: check all that apply

Contact Information

These are the details of the facility supervisor or Principal Investigator. This may not be the senior postdoc, research associate/scientist, graduate student or technician.

Structure and Location

When filling in this section, keep in mind all of your rooms including those in animal facility. The "containment zone" is your BSL2 lab room. You may have multiple containment zones. With respect to the animal facilities, the entire facility is the containment zone. A containment zone would be defined by requiring authority and training to enter the zone.

Q3.1.5 - in the CAF yes there are separate procedure rooms. Do you have an animal room where there is a separate PM area?

Q3.1.1 -

Q3.1.2/4.6.8 - Your report area will either be a separate room inside the containment zone, a separate room inside the containment zone, or a designated area inside the containment zone. What are your work practices which prevent contamination of these areas? Removal of PPE and washing hands before exit of the containment zone or entry into the designated area? Prohibition of food/drink, smoking, insertion/removal of contact lenses, application of makeup inside the containment zone?

Containment Barrier

Q3.2.1 - this includes windows to the outside and windows to corridors

Q3.2.3 - are those windows resistant to bad weather, are they shatterproof, are they sealed?

Access

Q3.3.1 -

Q3.3.2 - Describe the sign outside your door. Universal biohazard symbol, containment level, emergency numbers, and entry requirements (PPE).

Q3.3.4/4.5.2 -

Q3.3.9 - An anteroom with respect to CL2 labs or SA facilities are primarily for the purposes of donning/doffing PPE and storage of necessary materials. The anteroom may be an enclosed area prior to entry into the containment zone or it may be a designated area prior to entry into the containment zone or it may be a designated "clean" area inside the containment zone.

Q3.3.12/3.3.17 - If you do not require a change of clothing for entry into the containment zone, please state.

Surface Finishes and Casework

This includes benches, desks, floors, door trim, baseboards etc.

Q3.4.1 -

Q3.4.2 -

Q3.4.3 -

Q3.4.5 -

Q3.4.6 - this is in accordance with function. The function of most CL2 floors is to be sealed and cleanable but remain dry. THey are not to be hosed down. In contract, animal facility floors are designed to be hosed down.

Q3.4.8 - this is also in accordance with function. In most CL2 labs, the intersection between wall and floor is covered with baseboard but is not waterproof. In contrast, animal facility floorings are typically expoxy which runs up the wall. They are leakproof.

Air Handling

Q3.5.1 - An adequate number of air changes per hour will maintain proper temperature and humidity.

Facility Services

Q3.6.1 - Stand off devices secure ducting and pipes to the wall. There should be no unsecured services within the laboratory.

Q3.6.4/3.6.5 - The "hands free" feature of handwashing sinks is strongly recommended but is not required ie mandatory. The form itself implies that it is mandatory. Most handwashing sinks in CL2 containment zones at McMaster are not hands-free because it is not required.

Q3.6.6 -

Q3.6.6a -

Q3.6.19 - Are any of the following on emergency power? BSC, freezer/fridges, incubators, door locks?

Essential Biosafety Equipment

Q3.7.1 - "other" primary containment devices would be custom enclosures or sealed centrifuge rotors or buckets

Q3.7.2 - Most BSCs at McMaster are Class II type A2 where the exhaust air is HEPA filtered and recirculated back into the room. Type B2 BSC's are hard-ducted into the building HVAC system.

Q3.7.3 - if you have a piece of equipment through which pathogen is passed, ie cell sorter, aerosolizer how is the pathogen contained or decontaminated?

Q3.7.5 -

Q3.7.11 and Q3.7.11a - Do you physically (autoclave, irradiate etc) or chemically (disinfectants) decontaminate items inside the containment zone? If not (most cases), you must securely package your waste for transport and disposal by a disposal company.

Q3.7.13 -

Q3.7.16 - Vaccuum systems include aspiration setups and in house vaccuum systems.

Q3.7.18 - Phone, internet, fax? Other?

Biosafety Program Management

Q4.1.1 - We have a Presidential Biosafety Advisory Committee, a Biosafety Officer and an Biosafety Auditor. All contribute to the activities which make up the biosafety program.

Q4.1.4a/4.1.10 - The overarching risk assessment for the containment facility (the PIs lab) is through our former biohazard approval process and the current BUP process where we capture pathogens and activities. This is reviewed by PBAC to ensure proper containment level is assigned to mitigate risks associated with the activities. Documentation is within the approval forms and the committee minutes. Local risk assessments are performed when a proposed project follows nonstandard or new procedures. A local risk assessment is performed by a subcommittee of PBAC. Documentation of these LRAs are captured within the meeting minutes. Biosecurity risk assessments are conducted on all projects through the former biohazard approval process and current BUP process. All information is documented within the approval forms.

Q4.1.5 - The process of an LRA includes examining the propoposed activity, determining all the risks associated with that activing and devising ways to maintain containment and personal protection while perfomring that activity

Q4.1.6 - McMaster does have a respiratory protection program in place. Your lab may not require the use of respirators and thus may be N/A.

Q4.1.7 - This is achieved through the BUP process where the Biosafety Officer and PBAC can monitor inventories. The lab auditing process allows monitoring for compliance within the containment zone (PI's laboratory). A biosafety manual is currently under development, however all elements (training, SOPs, relevant materials) are found within the biosafety website. Inside the containment zone, the supervisor is to put together a binder of SOPs which comprise the local biosafety manual. Authorization of personnel to work in the containment zone is facilitated by training provided by the Biosafety Office, however secure access is facilitated by the supervisor.

Q4.1.8 - The University biosafety manual is currently under development, however all elements required in the manual can be access multiple McMaster hosted websites.

Q4.1.11 - A biosecurity plan can be found here.

Q4.1.12 - An inventory of the pathogens and toxins handled in the containment zone should be kept within the containment zone.

Q4.1.13/4.3.13/4.6.39/4.6.40/4.8.11/4.9.7 - Imports, lab inspections, BSC certifications, biosafety training and retraining, incidents involving biohazards are processed through the biosafety office. Routine verification of decontamination equipment is facilitated through the biosafety office, however the local lab supervisor implements the program.

Medical Surveillance Program

Q4.2.1 -

Q4.2.3 -

Q4.2.5a -

Q4.2.5b -

Training Program

Q4.3.1/4.3.11 -

Q4.3.2 -

Q4.3.3/4.3.5/4.3.6/4.3.7/4.1.9 -

Q4.3.4 -

Q4.3.8 -

Q4.3.9 -

Q4.3.10 -

Q4.3.12 -

Q4.3.13 -

Personal Protective Equipment

Q4.4.1 -

Q4.4.2 -

Q4.4.4 -

Entry and Exit of Personnel, Animals and Materials

Q4.5.1 -

Q4.5.4 -

Q4.5.6/3.3.11 -

Q4.5.7 -

Q4.5.8 -

Q4.5.10 -

Q4.5.11/4.6.15 -

Work Practices

Q4.6.2/4.6.5/4.6.32 -

Q4.6.2/4.6.3/4.6.6 -

Q4.6.7 - We have designated areas in our facility where BSL2 work is to be conducted. All handling of BSL2 agents takes place inside a BSC. Inside the BSC, work is laid out from clean to dirty in order to minimize cross contamination. Additionally all BSL2 materials are to be contained or otherwise decontaminated and packaged inside the BSC for disposal to prevent release and potential exposure during transportation by the disposal company. Placement of BSCs within the containment areas are such that the HVAC systems do not impact proper functioning of BSCs. Storage of BSL2 agents in cold units are such that the cold unit is inside the containment laboratory which is locked, or if outside the containment laboratory, in a lockable room or the cold unit is lockable itself. We do not require laboratory BSL1 work to be completed prior to BSL2 work. All laboratory biohazardous work involves aseptic technique, good microbiological practices, containment and decontamination, thus there should be no carryover form one work area to another. These procedures are a result of recommendations in the Laboratory Biosafety Guidelines, 2004 edition. In our animal facility, there is a definite traffic flow pattern. All work is to be done from the cleanest rooms first and then the dirtiest rooms last. The order is clean-nonbiohazard >>> clean-biohazard >>> dirty-nonbiohazard. There are no dirty-biohazard rooms in our animal facilities.

Q4.6.9/4.6.10 -

Q4.6.11 -

Q4.6.18 -

Q4.6.19 -

Q4.6.20 -

Q4.6.26 -

Q4.6.29 -

Q4.6.33 -

Q4.6.34 -

Q4.6.35 -

Q4.6.38 -

Decontamination and Waste Management

Q4.8.1 -

Q4.8.2 -

Q4.8.3 -

Q4.8.5 -

Q4.8.7 -

Q4.8.8 -

Emergency Reponse Planning

Q4.9.1 -

Q4.9.1a/4.9.2 -

Q4.9.5 -

Q4.9.6 -