biosafety and procedures manual · 2.3.5 trained laboratory worker 2.3.6 absence of a principal...

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Revision Number Section / Part Revision Date

1 Section 3 / 3.1 Registration Process 2008.12.19

1 Section 4 / 4.1 Training Requirements 2008.12.19

1 Section 10 / 10.1 Prion Guidelines 2008.12.19

1 Section 1 / 1.1 Biohazardous Spills and Decontamination Procedures

2009.01.26

1 Section 1 / 1.2 Post Exposure Protocol – Biohazardous Materials

2009.01.26

1 Section 1 / 1.3 Post Exposure Protocol – Bloodborne Pathogens

2009.01.26

1 Section 1 / 1.4 Reporting of Exposure to Laboratory-Acquired Infections

2009.01.26

NEW Section 6 / 6.3 Safety-Engineered Medical Sharps 2010.02.16

1 Table of Contents 2010.02.16

BIOSAFETY AND PROCEDURES MANUAL

Section: Revision Control Sheet Date of Issue: 2008.01.07 Issued By: Environment, Health & Safety

Part: -- Revision #: 3 Revision Date: 2010.02.16

Pages: 1 Revised By: SS

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i. Revision Control Sheet ii. Table of Contents

SECTION 1 EMERGENCY RESPONSE PROCEDURES 1.1 Biohazardous Spills and Decontamination Procedures

1.1.1 Emergency Telephone Numbers 1.1.2 Reportable Incidents 1.1.3 Spill Clean Up 1.1.4 Spill Kit Location and Supplies

1.2 Post Exposure Protocol – Biohazardous Materials 1.3 Post Exposure Protocol – Bloodborne Pathogens 1.4 Reporting of Laboratory-Acquired Infections

SECTION 2 ORGANIZATION & ADMINISTRATION OF BIOSAFETY 2.1 Public Health Agency of Canada

2.1.1 The Office of Laboratories Security’s Biosafety Division 2.1.2 Laboratory Biosafety Guidelines 2.1.3 Material Safety Data Sheets (MSDS) 2.1.4 Importation of Human Pathogens 2.1.5 Export of Human Pathogens

2.2 Canadian Food Inspection Agency (CFIA) 2.2.1 Biohazard Containment and Safety Unit 2.2.2 Containment Standards for Veterinary Facilities 2.2.3 Importation and Transfer of Animal and Zoonotic Pathogens

and PIMs

2.3 University Of Calgary Occupational Health & Safety Policy 2.3.1 Biosafety Policy Statement 2.3.2 Biosafety Committee 2.3.3 Biosafety Officer 2.3.4 Principal Investigator 2.3.5 Trained Laboratory Worker 2.3.6 Absence of a Principal Investigator

2.4 Temporary Transfer of Biosafety Approval Due to Sabbatical or Extended Leave

SECTION 3 BIOHAZARDOUS MATERIALS REGISTRATION 3.1 Registration Process

3.1.1 Initial Registration 3.1.2 Registration Updates in Biohazard Laboratories

SECTION 4 BIOSAFETY TRAINING 4.1 Training Requirements

4.1.1 Training

BIOSAFETY AND PROCEDURES MANUAL

Section: Table of Contents Date of Issue: 2008.01.07 Issued By: Environment, Health & Safety

Part: -- Revision #: 1 Revision Date: 2010.02.16


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4.1.2 Documentation of Training

SECTION 5 RISK GROUP AND CONTAINMENT REQUIREMENTS 5.1 Risk Groups

5.1.1 Risk Group 1 5.1.2 Risk Group 2 5.1.3 Risk Group 3 5.1.4 Risk Group 4

5.2 Containment Levels 5.2.1 Containment Level 1 (CL1) 5.2.2 Containment Level 2 (CL2) 5.2.3 Containment Level 3 (CL3) 5.2.4 Containment Level 4 (CL4) 5.2.5 Animal Pathogen Containment Levels

5.3 Physical Requirements 5.3.1 Public Health Agency of Canada 5.3.2 Canadian Food Inspection Agency

5.4 Operational Requirements 5.4.1 Operational Practices for Laboratories 5.4.2 General Practices 5.4.3 Containment Level 2 5.4.4 Containment Level 3 5.4.5 Operational Practices for Animal Facilities 5.4.6 General Practices for Animal Facilities 5.4.7 AP Containment Level 2 5.4.8 AP Containment Level 3

SECTION 6 EQUIPMENT AND PROCESS CONTAINMENT TECHNIQUES

6.1 Biological Safety Cabinets 6.1.1 Introduction 6.1.2 Responsibilities 6.1.3 BSC Selection and Purchase 6.1.4 Installation and Certification 6.1.5 Use, Care and Maintenance 6.1.6 Additional Purchasing Considerations 6.1.7 Moving BSCs

6.2 Additional Equipment 6.3 Safety-Engineered Medical Sharps

SECTION 7 TRANSPORTATION OF BIOHAZARDOUS MATERIALS 7.1 Transportation Requirements

7.1.1 Movement of Hazardous Materials within Buildings 7.1.2 Ground Transportation 7.1.3 Air Transportation 7.1.4 Importation, Transfer and Containment of Animal Pathogens

SECTION 8 BIOHAZARD WASTE DISPOSAL 8.1 Waste Disposal Requirements

8.1.1 Clean Glass and Plastics 8.1.2 Yellow Biomedical Waste Containers

SECTION 9 LABORATORY DECOMMISSIONING AND DECONTAMINATION 9.1 Decontamination and Close-Out Procedures

9.1.1 Decontamination Procedures 9.1.2 Laboratory Close-Out

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SECTION 10 SPECIAL CONSIDERATIONS

10.1 Prion Guidelines 10.1.1 Introduction 10.1.2 Prion Biosafety Considerations 10.1.3 Prion Work Procedures

10.2 Sheep in Research 10.2.1 Introduction 10.2.2 Scope 10.2.3 Operational Practices 10.2.4 Physical Facilities

SECTION 11 DEFINITIONS

SECTION 12 REFERENCES

APPENDICES A The University of Calgary Occupational Health and Safety Policy B Biohazard Laboratory Safety Audit Questions

Section 1.1 - 1 of 2

1.1 BIOHAZARDOUS SPILLS AND DECONTAMINATION PROCEDURES

1.1.1 EMERGENCY TELEPHONE NUMBERS Fire Department 911 Ambulance Service (EMS) 911 Campus Security 220-5333 (Anytime) Campus Security has emergency contact numbers for Environment, Health and Safety (EH&S) personnel.

1.1.2 REPORTABLE INCIDENTS The following require IMMEDIATE reporting to Campus Security and the Biosafety Officer (BSO) ([email protected]) at any time: • A significant/major spill of biohazardous material, based on lab specific spill response procedures; • A spill in the Containment Level 3 laboratory; • Personal contamination (including clothing); • Known or suspected contamination and/or exposure; • Widespread contamination; • Loss or theft of any quantity of biohazardous materials; • A release of a quantity of a biohazardous substance into the environment not authorized by approved

activity; • An attempted or actual breach of security or sabotage at the site of the approved activity; • A serious illness or injury incurred or possibly incurred as a result of the approved activity; and • The death of any person at a biohazardous facility as an actual or suspected result of approved

activity.

All personnel in the laboratory must become familiar with the appropriate Emergency Response Plans.

REFER TO THE MSDS FOR THE PATHOGEN OR POTENTIAL PATHOGENS IN POTENTIALLY INFECTIOUS MATERIALS

NOTE: If a known or suspected exposure to biohazardous materials or bloodborne pathogens occurred, refer to

Post Exposure Protocol – Biohazardous Materials (except human blood and bodyfluids, human primary cell lines) Post Exposure Protocol – Bloodborne Pathogens

EMERGENCY RESPONSE PROCEDURES

Date of Issue: 2008.01.07 Section: 1 Issued By: Environment, Health & Safety

Revision #: 1 Part: 1.1 Biohazardous Spills and Decontamination Procedures Revision Date: 2009.01.26



1.1.3 SPILL CLEAN UP 1. Warn personnel in the area, evacuate the lab, and close all doors into the area. 2. Let the air exhaust system purge the room of aerosol for at least 30 minutes. 3. Get the laboratory spill clean up kit. Wear appropriate personal protective equipment (PPE) whenever

contacting or working with biohazardous materials. Always remove PPE when leaving laboratory or area of spill. If unsure of what to do at any time, contact EH&S (via Campus Security at 220-5333).

4. Pour an appropriate disinfectant solution around, but not on the spill. Mix the disinfectant with the spilled materials cautiously from the outside of the spill towards the centre.

5. Leave the area for a minimum of 30 minutes to allow the disinfectant to react with the spilled materials. 6. Carefully soak up the liquid with absorbent paper and place in an autoclave bag or other container for

immediate autoclaving. 7. Apply additional disinfectant to the area for 10 minutes then absorb with paper towels. 8. Wash the area with a detergent and rinse with clean water. 9. Report the spill to the Principal Investigator and complete an incident report through the Online Accident

Reporting System (OARS). More information regarding OARS can be found at: http://www.ucalgary.ca/safety/oars


1.2 POST EXPOSURE PROTOCOL – BIOHAZARDOUS MATERIALS This protocol is mandatory for every laboratory handling biohazardous materials (except human blood and body fluids, human cell lines).

*For human blood, bodily fluids and human primary cell lines implement the Bloodborne Pathogens Post Exposure Protocol.

Supervisor’s Responsibility in establishing a Post Exposure Plan for Biohazardous Materials:

1. Develop (a) post exposure plan(s) for biohazardous materials handled or stored in your facilities by completing the Post Exposure Plan template on page 2.

2. Attach the applicable MSDS(s) to the Post Exposure Plan(s). 3. Group pathogens with similar characteristics (route of exposure, virulence, resistance to antibiotics,

genetic modifications, pathogenicity, etc.) and complete additional post exposure plans as required. 4. Provide additional information that the attending physician should be made aware of.



Revision #: 1 Part: 1.2 Post Exposure Protocol – Biohazardous Materials Revision Date: 2009.01.26


Post Exposure Plan – Biohazardous Materials Principal Investigator:

Phone: Laboratory(ies):

Pathogen(s): If applicable, group pathogens with similar characteristics (route of exposure, virulence, resistance to antibiotics, genetic modifications, pathogenicity, etc.)

Information an attending physician needs to know: (Genetic Modifications, antibiotic resistance, etc.)


Protocol: In case of known or suspected exposure to the above pathogen(s):

1. Immediately wash your hands or exposed body parts with soap and water. Flush mucous membranes with water. Allow wound to bleed freely, if skin is broken. Do not squeeze.

2. Report the incident to your supervisor/manager and EH&S (via Campus Security at 220-5333). 3. If prescribed, take this document and applicable MSDS(s) and report to Foothills Hospital Emergency or

University Health Services (regular work hours) within a few hours of exposure (Max. 48 hours). 4. Emergency room physician or physician at U of C Health Services will conduct a risk assessment. 5. University Health Services or Foothills Emergency will provide initial counselling and post exposure

follow-up care to affected staff member. 6. Contact the Staff Wellness Center at 220-8990 to receive follow-up care in case of a high risk exposure. 7. Assist the PI in the completion of an incident report through the Online Accident Reporting System

(OARS). More information regarding OARS can be found at: http://www.ucalgary.ca/safety/oars 8. Complete a "Workers Report of Accident (WCB)" and submit to HR within 24 hours. Supervisor Responsibilities:

1. Ensure that the worker was treated with appropriate first aid measures as indicated in this protocol and direct the employee to Foothills Emergency or University Health Services.

2. Ensure the completion of an incident report through the Online Accident Reporting System (OARS). More information regarding OARS can be found at: http://www.ucalgary.ca/safety/oars

3. Ensure that the employee completes the "Workers Report of Accident (WCB)". 4. Complete the “WCB Employer's Report Form” 5. For human blood and body fluids, and human cell lines, implement the Bloodborne Pathogens Post

Exposure Protocol.


1.3 POST EXPOSURE PROTOCOL – BLOODBORNE PATHOGENS This protocol is a mandatory component for every laboratory handling or storing human blood and body fluids, and human cell lines.

*For biohazardous materials implement the Emergency Response Plan for Biohazardous Materials Post Exposure Protocol.

Post Exposure Plan – Bloodborne Pathogens

Principal Investigator:

Phone: Laboratory(ies):

Protocol: In case of known or suspected exposure to Bloodborne Pathogens

1. Immediately wash your hands or exposed body parts with soap and water. Flush mucous membranes with water. Encourage bleeding if skin is broken.

2. Report the incident to your supervisor/manager and EH&S (via Campus Security at 220-5333). 3. Report to Foothills Hospital Emergency or University Health Services (during regular work hours only)

within a few hours of exposure (Max. 48 hours). 4. Emergency room physician or physician at U of C Health Services will conduct a risk assessment. 5. University Health Services or Foothills Emergency will provide initial counselling and post exposure

follow-up care to affected staff member. 6. Contact the Staff Wellness Center at 220-8990 to receive follow-up care in case of a high risk exposure. 7. Assist the PI in the completion of an incident report through the Online Accident Reporting System

(OARS). More information regarding OARS can be found at: http://www.ucalgary.ca/safety/oars 8. Complete a "Workers Report of Accident (WCB)" and submit to HR within 24 hours.

Supervisor Responsibilities:

1. Direct the employee to Foothills Emergency or University Health Services. 2. Ensure the completion of an incident report through the Online Accident Reporting System (OARS).

More information regarding OARS can be found at: http://www.ucalgary.ca/safety/oars 3. Ensure the employee completes the "Workers Report of Accident (WCB)". 4. Complete the “WCB Employer's Report Form”.



Revision #: 1 Part: 1.3 Post Exposure Protocol – Bloodborne Pathogens Revision Date: 2009.01.26


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Dr. Steven Boyd 403-978-3550 HRIC 3A29 Dr. Benedikt Hallgrímsson 403-615-2647 HRIC 3A29

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1.4 REPORTING OF LABORATORY-ACQUIRED INFECTIONS Laboratory Acquired (Associated) Infection (LAI) is defined as an infection that resulted from laboratory work, whether it occurred in a laboratory worker, or in another person who happened to be exposed, as a result of work with a biohazardous material. Individuals who work in a laboratory that handles infectious materials are at risk of exposure to the substances they handle. Historically, incidences of exposures to laboratory-acquired infections are grossly underestimated due to a lack of reporting procedures or a reluctance of the worker to report exposures. The University of Calgary requires the reporting of all workplace incidents (whether an injury or exposure has occurred or not) including the reporting of any potential, suspected and actual laboratory-acquired infections. The reporting of such exposures is beneficial for every worker since reports can lead to improvements in safe work procedures and equipment to prevent further exposures to biohazardous materials. All exposures and potential exposures to biohazards must be reported to the Principal Investigator and Campus Security at 220-5333. An incident report must be completed by the Supervisor or the Affected Person through the Online Accident Reporting System (OARS) within 24 hours. More information regarding OARS can be found at: http://www.ucalgary.ca/safety/oars Laboratory workers are exposed to LAIs by: • Punctures of the skin via needles and sharps; • Animal bites/scratches; • Inhalation (aerosilization of biohazardous materials); • Ingestion; • Spills and splashes; and • Contact with mucous membranes (i.e. conjunctivae).



Revision #: 1 Part: 1.4 Reporting of Exposure to Laboratory-Acquired Infections Revision Date: 2009.01.26


ORGANIZATION AND ADMINISTRATION

OF BIOSAFETY


Revision #: NEW Part: 2.1 Public Health Agency of Canada Revision Date: --

Pages: 2 Revised By: --

2.1 PUBLIC HEALTH AGENCY OF CANADA The Public Health Agency of Canada (PHAC) has legislative authority over the handling, storage, and importation of biohazardous materials affecting humans only.

2.1.1 The Office of Laboratory Security’s Biosafety Division The Office of Laboratory Security (OLS) was established within the Centre for Emergency Preparedness and Response (CEPR) as a result of the Health Canada realignment process. Canada's national centre of expertise for biosafety and biocontainment, namely the Office of Biosafety (OBS), was amalgamated into the new Office of Laboratory Security from the Laboratory Centre for Disease Control (LCDC) in June 2000. The OBS was established within Health Canada in 1980 and it's mission is to ensure effective, evidence-based biosafety interventions on a national basis through regulatory control, surveillance, applied research, and timely dissemination of information related to needs, priorities and strategies. The Office of Laboratory Security: • develops and applies national biosafety policies and guidelines; • assesses permit applications for importation of human pathogens; • issues permits for importation of human pathogens; • certifies level 3 and 4 containment facilities; • offers consultative services to microbiological laboratories; • acts as a resource centre by providing training services and information; and • acts as a WHO collaborating centre.

2.1.2 Laboratory Biosafety Guidelines The “Laboratory Biosafety Guidelines (3rd ed., 2004)” (LBG 2004) is the guiding document for the use, handling and storage of human pathogens. The University of Calgary considers the requirements of the LBG 2004 as the industry standard, and the minimum standard when working with human pathogens or PIMs at the University of Calgary. The Guidelines are available at: http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index.html

2.1.3 Material Safety Data Sheets (MSDS)

The Office of Laboratory Security also maintains an on-line library of pathogen MSDSs at: http://www.phac-aspc.gc.ca/msds-ftss/index.html


http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index.html

http://www.phac-aspc.gc.ca/msds-ftss/index.html

The Workplace Hazardous Materials Information System (WHMIS) legislation includes pathogens under the classification D, division 3 – Biohazardous Infectious Materials – and states that access to an MSDS is mandatory.

2.1.4 Importation of Human Pathogens

The Human Pathogens Importation Regulation (SOR/94-558) (HPIR) is the regulatory authority for facilities wishing to import human pathogens into and transfer specimens within Canada. These regulations were developed to ensure that facilities have appropriate containment for the pathogens they wish to handle. Any facility wishing to import a human pathogen requiring containment levels 2, 3 or 4 must have a valid PHAC permit before importation. Pathogens requiring containment level 1 facilities are not regulated by the HPIR, and therefore a permit is not required for their importation. Applications for permits to import human pathogens can be obtained either by calling the Office of Laboratory Security directly at (613) 957-1779 or by downloading the application form from the Office of Laboratory Security’s website at: http://www.phac-aspc.gc.ca/ols-bsl/pathogen/pdf/permit_application.pdf Similarly, a copy of the HPIR and frequently asked questions about the importation process can also be accessed at the Office of Laboratory Security’s website. Applicants wishing to import and transfer human pathogens must have facilities that comply with the operational practices and physical requirements for a containment laboratory detailed in these Guidelines. For facilities wishing to import pathogens requiring containment levels 3 and 4, PHAC certification stating that the laboratory meets the requirements of the Laboratory Biosafety Guidelines is required before a permit is issued. The requirements for certification of a containment laboratory are detailed in Chapter 5 (of LBG 2004). Facilities wishing to import pathogens requiring containment level 2 are to perform a self-inspection to ensure that the facility meets the Laboratory Biosafety Guidelines’ requirements and the self-inspection is subject to verification by PHAC inspectors at any time. Many human pathogens are also classified as animal pathogens. Animal pathogens are regulated by the Canadian Food Inspection Agency (CFIA) (see section 10.4, Importation of Animal Pathogens, in this chapter). For importation of pathogens that are common to both animals and humans, an import permit is required from the CFIA as well as PHAC. It is the responsibility of the importer to ensure that all appropriate import permit documentation has been obtained prior to importation of any pathogen into Canada. 2.1.5 Export of Human Pathogens

Many pathogens and associated equipment that are destined for export from Canada require permits. Canada is a signatory to the 1972 Biological and Toxin Weapons Convention. This international convention stresses the goal of non-proliferation of biological and toxin weapons through the prohibition of the development, production, stockpiling or acquisition of microbiological (biological) and toxin weapons and their destruction. The Department of Foreign Affairs and International Trade Canada currently controls certain toxicological and biological agents as well as their related equipment, components, materials and technology, under item 2007 of the Export Control List of this international convention. For assistance or advice, contact the Department of Foreign Affairs and International Trade Canada, Export Control Division at (613) 996-2387 or obtain information on their website at: http://www.dfait-maeci.gc.ca/eicb/


http://www.phac-aspc.gc.ca/ols-bsl/pathogen/pdf/permit_application.pdf

http://www.dfait-maeci.gc.ca/eicb/

ORGANIZATION AND ADMINISTRATION

OF BIOSAFETY


Revision #: NEW Part: 2.2 Canadian Food Inspection Agency Revision Date: --


2.2 CANADIAN FOOD INSPECTION AGENCY (CFIA)

The CFIA is responsible for the administration and enforcement of the following Acts: • Agriculture and Agri-Food Administrative Monetary Penalties Act; • Canada Agricultural Products Act; • Canadian Food Inspection Agency Act; • Feeds Act; • Fertilizers Act; • Fish Inspection Act; • Health of Animals Act; • Meat Inspection Act; • Plant Breeders’ Rights Act; • Plant Protection Act; • Seeds Act; • Consumer Packaging and Labelling Act; and • the enforcement of the Food and Drugs Act as they relate to food.

2.2.1 Biohazard Containment and Safety Unit

The Biohazard Containment and Safety Unit works with CFIA scientists and technical experts to establish the biocontainment levels, procedures and protocols that are required to work safely with animal and zoonotic pathogens, chemical hazards, and plant pests of quarantine significance, and to protect laboratory staff, the Canadian public, and the environment.

2.2.2 Containment Standards for Veterinary Facilities

This standard is the applicable document for all work involving animal and zoonotic pathogens and PIMs and is available on-line at: http://www.inspection.gc.ca/english/sci/lab/convet/convete.shtml Further information regarding work procedures and biosafety considerations when working with prions is available in Section 10.1: Prion Guidelines in this manual.

2.2.3 Importation and Transfer of Animal and Zoonotic Pathogens and PIMs

The Health of Animals Act, 1990, and the Health of Animal Regulations give the CFIA the legislative authority to control the use of imported animal pathogens and pathogens associated with reportable animal diseases. These include materials of animal origin that contain potential pathogens (PIMs). Refer to the Health of Animals Act and the Regulations for complete information.


http://www.inspection.gc.ca/english/sci/bio/bioe.shtml

http://www.inspection.gc.ca/english/sci/lab/convet/convete.shtml

Permits are required for the importation of all animal pathogens into Canada. In the case of pathogens that affect both humans and animals, import permits are required from both PHAC and the CFIA. If an agent is brought into Canada under an import permit that restricts its distribution, further approval must be obtained from the CFIA before transferring the agent to another location. The CFIA also establishes the conditions under which animal pathogens will be maintained and work will be carried out. It is necessary to consider not only the risk to human health but also the level of containment needed to prevent escape of an animal pathogen into the environment, where it may constitute a risk to any indigenous animal species. The CFIA publication “Containment Standards for Veterinary Facilities” outlines the minimum design, and physical and operational requirements for Canadian laboratories and animal facilities that import and work with animal or zoonotic pathogens. Laboratories that apply to import animal or zoonotic pathogens must demonstrate that they meet these requirements before the CFIA can issue an import permit. Animal pathogens, including pathogens that affect both humans and animals, under the control of the CFIA are listed in a database maintained by the Biohazard Containment and Safety Division, CFIA. This is a dynamic list that is continuously amended to include emerging pathogens that may require restriction. Animal pathogens that are considered non-indigenous to Canada form a portion of this database and are severely restricted. For each animal pathogen, the CFIA must be consulted for its importation, use and distribution. Information on the status of animal pathogens may be obtained from: Biohazard Containment and Safety Division Canadian Food Inspection Agency 159 Cleopatra Drive Ottawa, Ontario K1A 0Y9 Tel.: (613) 221-7068 Fax: (613) 228-6129 http://www.inspection.gc.ca/english/sci/bio/anima/animae.shtml Information on the status of plant pathogens under the Plant Protection Act and Regulations can be obtained by contacting: Plant Health and Production Division Permit Office 59 Camelot Drive Ottawa, Ontario K1A 0Y9 Tel.: (613) 228-2342 (ext. 4334 or 4333) Fax: (613) 228-6605


UNIVERSITY OF CALGARY

OCCUPATIONAL HEATH & SAFETY


Revision #: NEW Part: 2.3 University of Calgary Occupational Health & Safety Revision Date: --


2.3 UNIVERSITY OF CALGARY OCCUPATIONAL HEALTH & SAFETY The University of Calgary considers health and safety to be a priority and is committed to providing a safe and healthy work and study environment for the entire University community. This will be possible by meeting or exceeding all regulatory requirements and ensuring that the University fully implements its Occupational Health and Safety Management System. The goal of the University of Calgary is to integrate health and safety into all aspects of University activities. All faculty members, employees, students, volunteers, contractors and visitors are required to comply with all University health and safety policies, procedures and rules, as well as all applicable legislation. A copy of the University of Calgary Occupational Health & Safety Policy is provided in Appendix A.

2.3.1 Biosafety Policy Statement

The University of Calgary (UofC) has the legal obligation to implement and maintain a Biosafety Program to protect its workers, volunteers, visitors, physical assets and the environment from exposure to, and contamination with, biohazardous materials (biohazards) that are being used in research within its facilities. This legal obligation applies to the entire University community, including workers, undergraduate students, volunteers, and visitors. In addition, the program also applies to University consultants, contractors, vendors, suppliers, partners and leasees of University space to the extent that University workers, undergraduate students, volunteers and visitors, as well as University resources are involved or impacted. The University of Calgary is committed to complying with the Alberta Occupational Health and Safety Act and Codes, Health Canada’s “Laboratory Biosafety Guidelines”, the Canadian Food Inspection Agency’s “Laboratory Standards for Veterinary Facilities”, and all relevant legislation. • Compliance with 4.1 Chemical Hazards, Biological Hazards and Harmful Substances of the

Occupational Health and Safety Code 2006, must be practiced with respect to the acquisition, usage, handling, storage, transfer and disposal of all biohazardous materials and all other sources of biohazards in all areas under the control of the University of Calgary.

• Compliance with 4.1 Chemical Hazards, Biological Hazards and Harmful Substances of the Occupational Health and Safety Code 2006, must be practiced with respect to the design and construction of laboratories, processing areas, storage facilities, support structures, equipment, and any other amenities that are used, or will potentially be used, for work with biohazardous materials.

• The University of Calgary has an established Biosafety Program for workplace safety and regulatory compliance in accordance with the requirements of Compliance with 4.1 Chemical Hazards, Biological Hazards and Harmful Substances of the Occupational Health and Safety Code 2006. The responsibility and accountability of all UofC personnel is fundamental to the effective operation of the Biosafety Program. The University Biosafety Committee shall provide advice and direction on program


development and biosafety issues, and the Biosafety Officer ([email protected]) shall administer and ensure biosafety on a day-to-day basis.

2.3.2 The Biosafety Committee The University Biosafety Committee is advisory to the Vice-President (Research). The committee is responsible for recommending policies and procedures to be followed pertaining to safety in handling biohazardous materials in accordance with the applicable most current version of Health Canada’s “Laboratory Biosafety Guidelines” and/or Agriculture & Agri-food Canada’s “Containment Standards for Veterinary Facilities” and relevant Federal and Provincial standards, acts and regulations, and municipal bylaws. The storage, use and handling of biohazardous materials is conditional on Biosafety Committee Approval. To receive approval, the Principal Investigator (PI) must fulfill all registration requirements as outlined below.

2.3.3 Biosafety Officer The University Biosafety Officer (BSO) ([email protected]) is responsible for providing assistance to, and is a member of, the UofC Biosafety Committee whose duties shall include, but are not limited to: • Administers, implements, and provides consultation regarding the Biosafety Program; • The BSO has the authority to suspend any biohazardous procedures which are considered unsafe, or

that have the potential to cause harm to a member of the general public, or the environment; • Investigates and reports to the Biosafety Committee incidents which would result in contamination or

exposure to personnel, or contamination to property; • Ensures that each laboratory has emergency response plans developed and implemented for dealing

with accidental spills and personnel contamination, and investigating research laboratory accidents; • Reports to the Biosafety Committee all significant problems with and violations of the Guidelines, and

all significant research-related accidents and illnesses of which the BSO becomes aware, unless the BSO determines that the Principal Investigator has done so;

• Consults with researchers regarding the storage, use, and disposal of biohazardous materials; • Provides up to date materials and instruction of the Biosafety Course Modules; • Provides advice on laboratory security; and • Provides technical advice to the Principal Investigator and the Biosafety Committee on research safety

procedures.

2.3.4 Principal Investigators (PIs) All PIs require approval from the Biosafety Committee to store, handle, and use biohazardous materials, must oversee the scientific activities and are accountable for activities undertaken by their workers. PIs must ensure adherence of all biohazardous requirements.

2.3.5 Trained Laboratory Workers Laboratory workers must know and comply with applicable policies, procedures, and regulations when working with biohazardous substances. The following is a list of the duties, regulations, and information that each worker must comply with: • Know and understand the biohazardous substances they are handling; • Must ensure they practice and adhere to all biohazardous requirements; • Know what to do in case of a spill or accident with a biohazardous substance;


mailto:[email protected]


• KEEP ALL FOOD, beverage containers, or anything associated with food (i.e. utensils) out of the laboratory;

• Understand and follow all laboratory safe work procedures; • Conduct biohazardous work procedures using good work practices; • Decontaminate when contamination is found; • Keep the work area as clean as possible! After an experiment all areas must be decontaminated; and • Dispose of biohazardous wastes from the laboratory as soon as possible.

2.3.6 Absence of a Principal Investigator

If a PI is absent from campus for a period of time that exceeds normal vacation entitlement (for any reason including medical leave, sabbaticals, move to another centre whilst retaining adjunct status, etc.), arrangements must be made to transfer oversight and responsibility to another faculty member with existing Biosafety Committee approval. Such arrangements must be submitted in writing and are subject to review and approval by the Biosafety Committee. If the necessary arrangements are not made, the Biosafety Committee approval will be suspended, and all storage, use, and handling of biohazardous materials must cease. Upon returning to campus, the PI has to initiate a new approval process.

Responsibilities of the Department Head, Institute or Centre Director In the event of acute illness or other unforeseen circumstances, where paperwork is not completed but the Department Head, Institute or Centre Director becomes aware of a PI’s absence from campus, it is his/her responsibility to notify the Biosafety Committee. In the event of an acute situation where no arrangements have been made to cover active protocols, it is the responsibility of the Department Head, Institute or Centre Director, to identify oversight arrangements in consultation with the Biosafety Committee. Notes: Department Head, Institute or Centre Director means the Primary Department Head, Institute or Centre Director, if the PI is cross-appointed.


BIOSAFETY APPROVAL HOLDER I, Dr. , Please print will be on sabbatical/extended leave from to _________________ Dr. will be the designated Biosafety Approval Holder, and will assume all responsibilities for my Biosafety Approval. Principal Investigator’s Signature:

TEMPORARY TRANSFER OF BIOSAFETY APPROVAL DUE TO

SABBATICAL OR EXTENDED LEAVE

Section: 2 Date of Issue: 2008-01-07 Part: 2.4 – Temporary Transfer of Biosafety Approval Due to

Sabbatical or Extended Leave Revision #: NEW

Pages: 1 Revision Date: --

------------------

DESIGNATED BIOSAFETY APPROVAL HOLDER I, Dr. , Please print will assume all responsibilities for Dr. Biosafety Approval while he/she is away on sabbatical/extended leave from _____________ to ______________ Designated Biosafety Approval Holder’s Signature: Date received in Biosafety Office: _________________________



3.1 REGISTRATION PROCESS

3.1.1 Initial Registration (New Laboratories/Principal Investigators) The storage, use and handling of biohazardous materials is conditional on Biosafety Committee Approval. To receive approval, the PI must fulfill all registration requirements as outlined below. To initiate the on-line biohazard registration, the Principal Investigator or designate should follow the outlined steps:

1. Visit the URL: https://rmfrmsrv.ucalgary.ca/BiohazardHandling/login.cfm

2. Create your user name and password

3. Enter the required information: • pathogens or potentially infectious materials (PIMs); • personal information; • contact phone numbers; • room numbers, including all areas where biohazards are handled or stored, core facilities,

shared facilities, animal holding areas, cold rooms, etc.

4. After entering the required information, the PI or designate will inform the BSO by email indicating that the biohazardous materials have been entered into the on-line registration.

5. Upon receipt of notification that the on-line registration has been completed, the BSO will review

the information, and schedule a Biosafety Audit with the PI or designate (Refer to Appendix B for a copy of the bioaudit questions).

6. Upon successful completion of the Biosafety Audit, the BSO will produce the approvals and

laboratory postings, and submit the approvals to the chair of the Biosafety Committee for signature.

3.1.2 Registration Updates in Biohazard Laboratories Any changes that occur in an approved biohazard laboratory, including the introduction of new pathogens or PIMs, contact information, personal information, room numbers in which the biohazardous materials are handled or stored, etc., must be updated on the on-line registration by the PI or designate immediately. Note: Changes in the use of pathogens, laboratories, etc. may require an audit prior to receiving Biosafety Committee approval.

BIOHAZARDOUS MATERIALS REGISTRATION


Revision #: 1 Part: 3.1 Registration Process Revision Date: 2008.12.19


https://rmfrmsrv.ucalgary.ca/BiohazardHandling/login.cfm


4.1 TRAINING REQUIREMENTS A requirement of the University of Calgary’s Biosafety Program is that only persons properly trained to work with biohazardous materials and informed of the hazards involved are allowed to handle biohazardous substances.

4.1.1 Training All persons handling biohazardous materials are required to attend the mandatory “Introduction to Biosafety” course module. Course information and registration is available at: http://rmfrmsrv.ucalgary.ca/SafetyCourse/course/ In addition, Principal Investigators are required to provide Worksite Specific training to personnel, consisting of: • Procedures for the safe storage, usage and handling the biohazardous material, • If applicable, the procedures for safely manufacturing the biohazardous material, • The procedures to be followed when there are fugitive emissions, and • The procedures to be followed in case of emergency involving biohazardous materials.

The following optional Biosafety courses are available: • Zoonoses and Animal Hazards - Module 2 • Bloodborne Pathogens - Module 3 • Hands-On Biosafety - Module 4 • Biosafety of Viral Vectors - Module 5

The University of Calgary’s Biosafety Course Modules are offered by Environmental Health & Safety (EH&S) a few times per year dependant upon demand. Registration for the Biosafety Course Modules is on a first come basis. The Principal Investigator will ensure that all individuals complete Module 1 of the Biosafety course modules prior to using biohazardous materials in any laboratory at the University of Calgary.

4.1.2 Documentation of Training All training must be documented at the time of training and available in the Biosafety Manual or Laboratory Safety Manual to be presented to the BSO or any other work place inspector at any time. A copy of the Research Worker Training Record can be found on the EH&S website.

BIOSAFETY TRAINING


Revision #: 1 Part: 4.1 Training Requirements Revision Date: 2008.12.19

Pages: 1 SS

http://rmfrmsrv.ucalgary.ca/SafetyCourse/course/

RISK GROUP AND CONTAINMENT

REQUIREMENTS


Revision #: NEW Part: 5.1 Risk Groups Revision Date: --


5.1 RISK GROUPS The Public Health Agency of Canada has developed a classification system as described in their Laboratory Biosafety Guidelines, 3rd Edition, 2004. The classification of organisms according to risk group has traditionally been used to categorize the relative hazards of infective organisms. The factors used to determine which risk group an organism falls into is based upon the particular characteristics of the organism, such as: • pathogenicity; • infectious dose; • mode of transmission; • host range; • availability of effective preventive measures; and • availability of effective treatment.

These classifications presume ordinary circumstances in the research laboratory or growth in small volumes for diagnostic and experimental purposes. Four levels of risk have been defined as follows:

5.1.1 Risk Group 1 (low individual and community risk) Any biological agent that is unlikely to cause disease in healthy workers or animals.

5.1.2 Risk Group 2 (moderate individual risk, low community risk) Any pathogen that can cause human disease but, under normal circumstances, is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures rarely cause infection leading to serious disease; effective treatment and preventive measures are available, and the risk of spread is limited.

5.1.3 Risk Group 3 (high individual risk, low community risk) Any pathogen that usually causes serious human disease or can result in serious economic consequences but does not ordinarily spread by casual contact from one individual to another, or that causes diseases treatable by antimicrobial or antiparasitic agents.

5.1.4 Risk Group 4 (high individual risk, high community risk) Any pathogen that usually produces very serious human disease, often untreatable, and may be readily transmitted from one individual to another, or from animal to human or vice-versa, directly or indirectly, or by casual contact. A list of human pathogens categorized according to Risk Group can be obtained by calling the Office of Laboratory Security directly at (613) 957-1779 or accessing their Web site: http://www.phac-aspc.gc.ca/ols-bsl/


http://www.phac-aspc.gc.ca/ols-bsl/index.html


REQUIREMENTS


Revision #: NEW Part: 5.2 Containment Levels Revision Date: --


5.2 CONTAINMENT LEVELS

Classification of organisms according to risk group is not meant to establish the actual handling of biological hazards in the laboratory setting. For example, the risk group system does not take into account the procedures that are to be employed during the manipulation of a particular organism. Containment levels are selected to provide the end-user with a description of the minimum containment required for handling the organism safely in a laboratory setting. In addition to the inherent characteristics of each organism as described above, the containment system includes the engineering, operational, technical and physical requirements for manipulating a particular pathogen. These containment levels are applicable to facilities such as diagnostic, research, clinical, teaching and production facilities that are working at a laboratory scale. Four containment levels are described as follows:

5.2.1 Containment Level 1 (CL1) This applies to the basic laboratory that handles agents requiring containment level 1. CL1 requires no special design features beyond those suitable for a well-designed and functional laboratory. Biological safety cabinets (BSCs) are not required. Work may be done on an open bench top, and containment is achieved through the use of practices normally employed in a basic microbiology laboratory.

5.2.2 Containment Level 2 (CL2) This applies to the laboratory that handles agents requiring containment level 2. The primary exposure hazards associated with organisms requiring CL2 are through the ingestion, inoculation and mucous membrane route. Agents requiring CL2 facilities are not generally transmitted by airborne routes, but care must be taken to avoid the generation of aerosols or splashes. Aerosols or splashes can settle on gloves and bench tops and become an exposure hazard (ingestion, mucous membranes, eyes) through contamination of the hands. Primary containment devices such as BSCs and centrifuges with sealed rotors or safety cups are to be used as well as appropriate personal protective equipment (i.e., gloves, laboratory coats, protective eyewear). As well, environmental contamination must be minimized by the use of handwashing sinks and decontamination facilities (autoclaves).

5.2.3 Containment Level 3 (CL3) This applies to the laboratory that handles agents requiring containment level 3. These agents may be transmitted by the airborne route, often have a low infectious dose to produce effects and can cause serious or life-threatening disease. CL3 emphasizes additional primary and secondary barriers to minimize the release of infectious organisms into the immediate laboratory and the environment. Additional features to prevent transmission of CL3 organisms are appropriate respiratory protection, HEPA filtration of exhausted laboratory air and strictly controlled laboratory access.


5.2.4 Containment Level 4 (CL4) This is the maximum containment available and is suitable for facilities manipulating agents requiring containment level 4. These agents have the potential for aerosol transmission, often have a low infectious dose and produce very serious and often fatal disease; there is generally no treatment or vaccine available. This level of containment represents an isolated unit, functionally and, when necessary, structurally independent of other areas. CL4 emphasizes maximum containment of the infectious agent by complete sealing of the facility perimeter with confirmation by pressure decay testing; isolation of the researcher from the pathogen by his or her containment in a positive pressure suit or containment of the pathogen in a Class III BSC line; and decontamination of air and other effluents produced in the facility. Currently, there are no CL4 laboratories at the University of Calgary. Should you have any questions regarding the level of containment required for your research, please contact the BSO ([email protected].)

5.2.5 Animal Pathogen Containment Levels

The following information was obtained from CFIA’s Containment Standards for Veterinary Facilities - Sections 1-3:

Laboratories and animal facilities handling pathogens of veterinary significance must be constructed and operated to appropriate containment levels and standards. The level required depends not only on the risk to human health but on a variety of other factors including the prevention of cross-contamination and the prevention of escape of animal pathogens into the environment where they might infect the indigenous animal population.

For each animal pathogen under the control of AAFC, APHD must be consulted for the level of containment needed (contact: Animal Health Division, 59 Camelot Dr., Nepean, ON K1A 0Y9, (613) 952-8000). This includes material of animal origin which may contain potential pathogens. The operational practices and physical design requirements for the animal pathogen (AP) containment levels are outlined in this document.

All APHD laboratories and animal facilities must comply with the minimum design and operational requirements listed in this standard. It should be noted that for each AP containment level described herein, the physical requirements meet or exceed the intent of the corresponding containment level listed in the HC Laboratory Biosafety Guidelines. However, some operational practices may differ where the animal pathogen does not represent a risk to human health (e.g. requirement for working in biological safety cabinet, requirement for use of positive-pressure ventilated suits).

Generally, work with endemic animal pathogens causing mild disease and of limited veterinary importance can be safely carried out in AP containment level 2 facilities. Facilities meeting level 2 criteria with specific level 3 enhancements (e.g. liquid effluent treatment) may be appropriate for resistant stages of certain animal parasites requiring an intermediate host. Pathogens causing serious livestock or poultry disease and spreading readily by the aerosol route require a higher level of containment (i.e. AP containment level 3 or 4, depending on the severity of disease).

Where the level of containment required is not specified in the APHD database, an assessment by the Chief, Laboratory Safety and principal investigator will establish specific containment requirements and operational protocols that must be followed.

Factors used to determine the required containment level include:

• infectious dose required to cause an infection; • route of infection (via aerosol transmission, injection, ingestion, absorption, invasion of mucous

membranes or abraded skin); • pathogenicity and virulence of the microorganism;



• host range; • morbidity and mortality rates for the individual disease; • vector necessary for transmission and disease; • quantity and concentration of the agent (i.e. in vitro, in vivo); • microorganism excreted in feces, urine, and/or exhaled; • inherent biological decay rate (specifically how long will the agent survive in the environment outside of

a susceptible host or culture medium); • endemicity of the microorganism; and • availability of effective vaccines, prophylactics and therapeutic treatment.



REQUIREMENTS


Revision #: NEW Part: 5.3 Physical Requirements Revision Date: --


5.3 PHYSICAL REQUIREMENTS

5.3.1 Public Health Agency of Canada

Chapter 4 of the LBG 2004 is designed to provide guidance on the design and layout required to achieve the four containment levels.

Chapter 4 of the LBG 2004 is divided into five matrices:

• Laboratory Location and Access; • Surface (i.e., floors, walls, ceilings, sealants) Finishes and Casework; • Heating, Ventilation and Air Conditioning (HVAC); • Containment Perimeter; and • Laboratory Services (i.e., water, drains, gas, electricity and safety equipment).

5.3.2 Canadian Food Inspection Agency

The physical requirements for animal pathogen (AP) containment levels 2, 3 and 4 are described in Chapter 3 of the CFAI’s Containment Standards for Veterinary Facilities. The laboratory facilities described, meet or exceed the physical requirements set out in the LBG 2004 and are appropriate for work with zoonotic agents in addition to strictly animal pathogens. The sections on animal facilities present design requirements unique to the handling of small and large animals in containment.


RISK GROUP AND CONTAINMENT REQUIREMENTS


Revision #: NEW Part: 5.4 Operational Requirements Revision Date: --


5.4 OPERATIONAL REQUIREMENTS The following are operational practices from the LBG 2004 for activities involving laboratory scale use of human pathogens at the four containment levels.

5.4.1 Operational Practices for Laboratories The operational practices for laboratories can be found at: http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/ch3_e.html#31

5.4.1.1 General Practices

The following general practices are required for all laboratories handling infectious substances.

1. A documented procedural (safety) manual must be available for all staff, and its requirements followed; it must be reviewed and updated regularly.

2. Personnel must receive training on the potential hazards associated with the work involved and the necessary precautions to prevent exposure to infectious agents and release of contained material; personnel must show evidence that they understood the training provided; training must be documented and signed by both the employee and supervisor; retraining programs should also be implemented.

3. Eating, drinking, smoking, storing of either, food, personal belongings, or utensils, applying cosmetics, and inserting or removing contact lenses are not permitted in any laboratory; the wearing of contact lenses is permitted only when other forms of corrective eyewear are not suitable; wearing jewellery is not recommended in the laboratory.

4. Oral pipetting of any substance is prohibited in any laboratory.

5. Long hair is to be tied back or restrained so that it cannot come into contact with hands, specimens, containers or equipment.

6. Access to laboratory and support areas is limited to authorized personnel.

7. Doors to laboratories must not be left open (this does not apply to an open area within a laboratory).

8. Open wounds, cuts, scratches and grazes should be covered with waterproof dressings.

9. Laboratories are to be kept clean and tidy. Storage of materials that are not pertinent to the work and cannot be easily decontaminated (e.g., journals, books, correspondence) should be minimized; paperwork and report writing should be kept separate from such biohazardous materials work areas.


10. Protective laboratory clothing, properly fastened, must be worn by all personnel, including visitors, trainees and others entering or working in the laboratory; suitable footwear with closed toes and heels must be worn in all laboratory areas.

11. Where there is a known or potential risk of exposure to splashes or flying objects, whether during routine operations or under unusual circumstances (e.g., accidents), eye and face protection must be used. Careful consideration should be given to the identification of procedures requiring eye and face protection, and selection should be appropriate to the hazard.

12. Gloves (e.g., latex, vinyl, co-polymer) must be worn for all procedures that might involve direct skin contact with biohazardous material or infected animals; gloves are to be removed when leaving the laboratory and decontaminated with other laboratory wastes before disposal; metal mesh gloves can be worn underneath the glove.

13. Protective laboratory clothing must not be worn in non-laboratory areas; laboratory clothing must not be stored in contact with street clothing.

14. If a known or suspected exposure occurs, contaminated clothing must be decontaminated before laundering (unless laundering facilities are within the containment laboratory and have been proven to be effective in decontamination).

15. The use of needles, syringes and other sharp objects should be strictly limited; needles and syringes should be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles; caution should be used when handling needles and syringes to avoid auto-inoculation and the generation of aerosols during use and disposal; where appropriate, procedures should be performed in a BSC; needles should not be bent, sheared, recapped or removed from the syringe; they should be promptly placed in a puncture-resistant sharps container (in accordance with Canadian Standards Association [CSA] standard Z316.6-95(R2000)) before disposal.

16. Hands must be washed after gloves have been removed, before leaving the laboratory and at any time after handling materials known or suspected to be contaminated.

17. Work surfaces must be cleaned and decontaminated with a suitable disinfectant at the end of the day and after any spill of potentially biohazardous material; work surfaces that have become permeable (i.e., cracked, chipped, loose) to biohazardous material must be replaced or repaired.

18. Contaminated materials and equipment leaving the laboratory for servicing or disposal must be appropriately decontaminated and labelled or tagged-out as such.

19. Efficacy monitoring of autoclaves used for decontamination with biological indicators must be done regularly (i.e., consider weekly, depending on the frequency of use of the autoclave), and the records of these results and cycle logs (i.e., time, temperature and pressure) must also be kept on file.

20. All contaminated materials, solid or liquid, must be decontaminated before disposal or reuse; the material must be contained in such a way as to prevent the release of the contaminated contents during removal; centralized autoclaving facilities are to follow the applicable containment level 2 requirements.

21. Disinfectants effective against the agents in use must be available at all times within the areas where the biohazardous material is handled or stored.

22. Leak-proof containers are to be used for the transport of infectious materials within facilities (e.g., between laboratories in the same facility).


23. Spills, accidents or exposures to infectious materials and losses of containment must be reported immediately to the laboratory supervisor; written records of such incidents must be maintained, and the results of incident investigations should be used for continuing education.

24. An effective rodent and insect control program must be maintained.

5.4.1.2 Containment Level 2

In addition to the general practices required for all laboratories handling infectious substances, the following describe the minimum operational practices required for containment level 2.

1. Good microbiological laboratory practices intended to avoid the release of infectious agents are to be employed.

2. BSCs must be used for procedures that may produce infectious aerosols and that involve high concentrations or large volumes of biohazardous material. Laboratory supervisors, in consultation with the Biological Safety Officer and/or the University Biosafety Committee, should perform a risk assessment to determine which procedures and what concentrations and volumes necessitate the use of a BSC.

3. Appropriate signage indicating the nature of the hazard being used (e.g., biohazard sign, containment level) must be posted outside each laboratory; if infectious agents used in the laboratory require special provisions for entry, the relevant information must be included on the sign; the contact information of the laboratory supervisor or other responsible person(s) must also be listed.

4. Entry must be restricted to laboratory staff, animal handlers, maintenance staff and others on official business.

5. All people working in the containment area must be trained in and follow the operational protocols for the project in process. Trainees must be accompanied by a trained staff member. Visitors, maintenance staff, janitorial staff and others, as deemed appropriate, must also be provided with training and/or supervision commensurate with their anticipated activities in the containment area.

6. Emergency procedures for spill clean-up, BSC failure, fire, animal escape and other emergencies must be written, easily accessible and followed. A record must be made of other people entering the facility during an emergency.

5.4.1.3 Containment Level 3

In addition to the operational practices for all laboratories handling infectious substances and those minimum requirements for containment level 2, the following describe the minimum operational practices required at containment level 3.

1. There must be a program for the management of biological safety issues in place with appropriate authority to oversee safety and containment practices (see Chapter 2, Section 2.5).

2. Everyone entering the containment laboratory must have completed a training course in procedures specific to the containment laboratory and must show evidence of having understood the training; training must be documented and signed by the employee and supervisor.

3. Employees working in the containment area must have knowledge of the physical operation and design of the facility (e.g., air pressure gradients between zones, directional airflow patterns, alarm signals for air pressure failure, containment perimeter).

4. A protocol specific to the operation of the laboratory must be developed and read by personnel; employees must certify in writing that they have understood the material in the protocol. This


should include entry and exit protocols for people, animals, equipment, samples and waste. General protocols must be supplemented with protocols specific to each project in progress.

5. Personnel must have demonstrated proficiency in microbiological practices and techniques.

6. Smoke testing (i.e., using a smoke pencil held at the door between the anteroom and the containment facility, and other doors as required) should be done periodically by laboratory staff to verify correct airflow; a containment check must be performed before entering the containment laboratory (e.g., verify correct reading on the pressure monitoring device).

7. People entering a containment facility must be well prepared and bring all materials they will need with them; if something has been forgotten, established traffic patterns must still be adhered to (i.e., do not go back to get it; either phone for someone to bring it or exit using proper protocols).

8. Routine laboratory cleaning must be done by personnel using the containment facility or by specific personnel dedicated and trained for this task.

9. The containment laboratory must be kept locked.

10. Infectious agents should be stored inside the containment laboratory; agents stored outside of the zone must be kept locked, in leakproof containers; emergency response procedures are to take into account the existence of such infectious agents outside of the containment level 3 laboratory.

11. Personal items such as purses and outdoor clothing must not be brought into the containment laboratory.

12. Drainage traps must be filled with liquid (i.e., through regular sink usage, automatic primers or by filling traps in areas that are not frequently used).

13. Laboratory samples and supplies may be carried into the containment laboratory or passed in through a pass-box; if the barrier autoclave is used to pass materials into the laboratory, the autoclave must have been cycled before the outer "clean side" door is opened.

14. Personnel entering the containment laboratory must remove street clothing and jewellery, and change into dedicated laboratory clothing and shoes; dedicated laboratory clothing and shoes must be removed before leaving the containment laboratory in a manner that minimizes any contamination of the skin with the potentially contaminated dedicated laboratory clothing. The use of full coverage protective clothing (i.e., completely covering all street clothing) is an acceptable alternative. When a known or suspected exposure may have occurred, all clothing, including street clothing, requires appropriate decontamination. Laboratories manipulating organisms, such as HIV, that are not infectious via inhalation, are not required to remove street clothing.

15. An additional layer of protective clothing (i.e., solid-front gowns with tight-fitting wrists, gloves, respiratory protection) may be worn over laboratory clothing when infectious materials are directly handled and should be removed after completion of work (e.g., dedicated for use at the BSC).

16. Centrifugation of infectious materials must be carried out in closed containers placed in sealed safety cups or rotors that are unloaded in a BSC.

17. Animals or arthropods that have been experimentally infected must remain in the laboratory or appropriate animal containment facility.

18. When a known or suspected aerosol exposure may have occurred, protocols based on a local risk assessment must be in place to determine whether showering is required on exit from the laboratory.


19. All activities with infectious materials are conducted in a BSC; if this is not possible, other primary containment devices in combination with personal protective clothing and equipment must be used; no work with open vessels containing infectious materials is conducted on the open bench.

20. Heat-sensitive materials that cannot be autoclaved out of the containment laboratory must be decontaminated at the containment barrier (e.g., fumigated with formaldehyde, vaporized hydrogen peroxide or a suitable alternative; disinfected using liquid chemicals; or subjected to other technology proven to be effective).

21. Emergency procedures for failure of air handling systems and other containment emergencies must be written, easily accessible and followed.

22. In the event of life-threatening emergencies, personal health and safety are a priority; exit protocols must be established whereby routine procedures might be bypassed; a reporting area must be identified where further steps must be taken (e.g., disinfecting footwear, changing, showering).

5.4.2 Operational Practices for Animal Facilities The operational practices for animal facilities can be found at: http://www.inspection.gc.ca/english/sci/lab/convet/convet6-8e.shtml

5.4.2.1 General Practices for Animal Facilities

As described in the CFAI’s Containment Standards for Veterinary Facilities, the following general practices are required when working in any containment laboratory or animal facility:

1. Entry must be restricted to laboratory staff, animal handlers, maintenance staff and other persons on official business.

2. Only persons meeting specific entry requirements (e.g. immunization, serum screening) may enter containment laboratories unless the facility has been appropriately decontaminated.

3. A health and medical surveillance program must be provided as recommended by Health Canada.

4. Personnel must receive training on the potential hazards associated with the work involved and the necessary precautions to prevent exposures to zoonotic agents and release of non-indigenous agents; personnel must show evidence that they understood the training provided; training must be documented and signed by both the employee and supervisor.

5. A documented procedural manual must be written and followed.

6. All persons (including visitors, maintenance staff, etc.) entering the containment area must be trained and know and follow the operational protocols for the project in process; trainees must be accompanied by a trained staff member.

7. Persons entering a containment facility must be well prepared and bring all materials they will need with them; if something has been forgotten, traffic patterns must still be adhered to (ie. do not go back to get it; either phone for someone to bring it or exit via proper protocols).

8. Employees working in the containment area must have general knowledge of the physical operation and design of the facility (e.g. air pressure gradients between zones, directional air flow patterns, alarm signals for air pressure failure, containment perimeter).

9. Traffic flow patterns from clean to dirty areas must be established and adhered to (i.e. move from least to most contaminated areas).


http://www.inspection.gc.ca/english/sci/lab/convet/convet6-8e.shtml

10. Smoke testing (i.e. with a smoke pencil) should be done periodically by lab staff to verify correct airflow.

11. Entry/exit protocols for persons, animals, equipment, samples, waste, etc. must be written, posted and followed; general protocols must be supplemented with protocols specific for each project in progress.

12. Emergency procedures for entry/exit, spill clean-up, air handling/biosafety cabinet failure, fire, animal escape and other emergencies must be written, posted and followed.

13. In the event of life-threatening emergencies, personal health and safety are a priority; exit protocols must be established whereby routine procedures are bypassed; a reporting area must be identified where further steps must be taken (e.g. disinfecting footwear, changing, showering) prior to leaving.

14. All spills, accidents, overt or potential exposures to infectious materials, and losses of containment (e.g. lab positive pressurization) must be reported immediately to the laboratory supervisor; written records of such incidents must be maintained.

15. An effective rodent and insect control program must be maintained.

5.4.2.2 AP Containment Level 2

The following describes the minimum operational practices required at AP containment level 2:

1. Laboratory personnel must be trained in and follow the safe use of laboratory equipment, biological safety cabinets, procedures to minimize the production of aerosols, decontamination and emergency response.

2. Open wounds, cuts, scratches and grazes should be covered with waterproof dressings.

3. Eating, chewing gum, drinking, smoking, storing food, and applying cosmetics are prohibited.

4. Personal items such as purses and outdoor clothing should be kept separate from work areas.

5. The work area containing hazardous materials should be kept free from materials not pertinent to the work and that cannot be easily decontaminated (e.g. journals, books, correspondence); paperwork and report writing should be kept separate from such work areas.

6. Laboratory reference material should be kept in the laboratory zone.

7. Hands should be washed frequently (after handling infectious materials, after removing gloves, and before leaving the laboratory).

8. Open-toed and high-heeled shoes must not be worn in the laboratory.

9. Long hair should be tied back so that it cannot come into contact with hands, specimens, containers, or equipment.

10. Gloves (e.g. intact vinyl or latex) must be worn when handling infectious materials; metal mesh gloves can be worn underneath the latex or vinyl glove to provide protection from sharps and needles.

11. Laboratory coats, gowns or coveralls must be worn when working in the laboratory; this clothing must not be worn in non-laboratory areas (e.g. offices, staff rooms, canteens, libraries).

12. Protective lab clothing should not be stored in the same locker as street clothing.


13. Contaminated clothing must be decontaminated prior to laundering (unless laundering facilities are within the laboratory zone and have been proven to be effective in decontamination).

14. Eye and face protection must be worn when it is necessary to guard against splashing hazardous materials, flying particles, and harmful light or other rays.

15. Laboratory doors must be kept closed as required by the facility design.

16. Biological safety cabinets must be used for procedures with potential for producing infectious aerosols (e.g. with zoonotic agents) and with high concentrations or large volumes of zoonotic materials.

17. Contaminated work surfaces must be decontaminated.

18. All contaminated materials must be decontaminated before disposal or cleaning for reuse.

19. Contaminated equipment leaving the laboratory for servicing or disposal must be appropriately decontaminated.

20. Efficacy monitoring of autoclaves using biological indicators must be done at least weekly, depending on the frequency of use of the autoclave, and records of the results kept on file; cycle log records (i.e. time, temperature and pressure) must also be kept on file.

5.4.2.3 AP Containment Level 3

In addition to the general operational practices listed for level 2, the following describes the minimum operational practices required at AP containment level 3:

1. A protocol specific to the operation of the lab must be developed and read by personnel; employees must certify in writing that they have understood the material in the protocol.

2. The laboratory zone must be kept locked.

3. Infectious agents should be stored inside the laboratory zone; agents stored outside the zone must be kept locked, in leakproof containers.

4. Personnel must have demonstrated proficiency in microbiological practices and techniques (e.g. experience in handling infectious organisms or cell cultures).

5. Personal items such as purses and outdoor clothing must not be brought into the laboratory zone.

6. A containment check must be performed prior to entering the laboratory zone (ie. verify negative lab pressurization as designed).

7. Water seals must be maintained in drainage traps (i.e. through regular sink/shower usage and/or by filling traps in areas that are not being used).

8. Laboratory samples and supplies may be carried into the laboratory zone or passed through a ventilated pass-box; where the barrier autoclave is used to pass materials into the laboratory, the autoclave must have been cycled prior to opening the outer "clean side" door.

9. Personnel entering the laboratory zone must remove street clothing and jewellery, and change into dedicated laboratory clothing and shoes.

10. Where full body protective clothing is not worn a shower is required on exit from the laboratory; where a known or suspected aerosol exposure has occurred (e.g. dropping infectious materials) a shower is required on exit from the laboratory zone.


11. A shower (including washing hair, beards) is required on exit from a laboratory zone handling non-indigenous animal pathogens; eye glasses must be disinfected at the containment barrier.

12. A second layer of protective clothing (i.e. solid-front gowns with tight-fitting wrists, gloves) should be worn over laboratory clothing when directly handling infectious materials (e.g. dedicated for use at the biological safety cabinet).

13. Contaminated clothing must be decontaminated prior to laundering (unless laundering facilities are within the laboratory zone and have been proven to be effective in decontamination of the microorganisms likely to be encountered).

14. All activities with infectious materials are conducted in a biological safety cabinet; where this is not possible, other physical containment devices in combination with personal protective clothing and equipment must be used; no work with open vessels containing infectious materials is conducted on the open bench.

15. Centrifugation of infectious materials must be carried out in sealed safety cups or rotors that are loaded and unloaded in a biological safety cabinet.

16. All contaminated waste materials leaving the laboratory zone must be decontaminated through a double-door autoclave at the barrier before disposal; both doors of the autoclave must not be opened simultaneously.

17. Heat sensitive materials that cannot be autoclaved out of the laboratory zone must be decontaminated at the containment barrier (e.g. fumigated with formaldehyde or vaporized hydrogen peroxide, disinfected using liquid chemicals, or other technology proven to be effective).



6.1 BIOLOGICAL SAFETY CABINETS (BSC)

The following elements are required for using and maintaining Biological Safety Cabinets (BSC).

6.1.1 Introduction When properly maintained and used in conjunction with good laboratory techniques, BSCs provide effective primary containment for work with biohazardous materials. In containment level 2 facilities, BSCs are used for procedures with the potential to produce infectious aerosols and for high concentrations or large volumes of infectious material. In containment level 3, all open vessel activities with infectious materials are conducted in a BSC. Every employee working in a BSC must be trained in its correct use and have a good understanding of the function.

6.1.2 Responsibilities Supervisors must ensure that all work with biohazardous materials with the potential of creating aerosols is performed in a BSC; workers are trained in the proper use of a BSC; BSCs are certified at least annually, on initial installation, and after a move or repairs. Workers must follow all health and safety standards, rules and regulations, report all hazardous conditions to the supervisor immediately and use the BSC appropriately.

6.1.3 BSC Selection and Purchase Only BSCs that meet the criteria of the National Sanitation Foundation Standard (NSF 49 Class II (laminar flow) Biosafety Cabinetry) and are NSF certified may be purchased. A listing of NSF Certified BSCs is accessible at the National Sanitation Foundation website located at http://www.nsf.org NSF/ANSI Standard 49 Class II (laminar flow) biosafety cabinetry applies to Class II biological safety cabinets, and is designed to minimize the hazards inherent in working with biohazardous materials assigned to biosafety containment levels 1, 2, or 3. The standard defines the tests for which a cabinet must comply to become NSF Certified. The standard includes basic requirements for design, construction, and performance that are intended to provide personnel, product, and environmental protection, reliable operation, durability, cleanability, noise level and illumination control, vibration control, and electrical safety. In addition, the standard includes detailed test procedures and informational annexes, including recommendations for installation, field certification tests, and decontamination procedures.

EQUIPMENT AND PROCESS CONTAINMENT TECHNIQUES


Revision #: NEW Part: 6.1 Biological Safety Cabinets Revision Date: --



6.1.4 Installation and Certification The protective air curtain at the front of the cabinet is fragile and can easily be disrupted by people walking parallel to it, by open windows, air supply registers or laboratory equipment that creates air movement (e.g., vacuum pumps, centrifuges). BSCs must be installed in accordance with the requirements outlined in the Canadian Standards Association (CSA) Biological Containment Cabinets (Class I and II): Installation and Field Testing. They must: • be located away from high traffic areas, doors and air supply/exhaust grilles that may interrupt airflow

patterns; • have minimum unobstructed distance of 40 cm between the exhaust outlet on top of the cabinet and

any overhead obstructions; • if possible, have a 30 cm clearance on each side of the cabinet to allow for maintenance access; • if ducted, have the blowers on the exhaust system located at the terminal end of the ductwork; and • failure of exhaust flow should signal an alarm to the user. To prevent pressurization of the cabinet, an

interlock system must be installed to prevent the cabinet blower from operating whenever the exhaust flow is insufficient; an anti-backflow device to prevent reverse airflow through the HEPA filter may be required.

The provision of natural gas to BSCs is not recommended. Open flames in the BSC create turbulence, disrupt airflow patterns and can damage the HEPA filter. When suitable alternatives (e.g., disposable sterile loops, micro-incinerators) are not possible, touch-plate microburners that have a pilot light to provide a flame on demand may be used. The correct operation of BSCs must be verified: • before they are used and then annually; • and after any repairs or relocation; and • in accordance with the field tests outlined in CSA Z316.3-95 or annex F of NSF 49.

These tests include the downward velocity profile, the work access face velocity, the HEPA filter leak test and the airflow smoke patterns. A copy of the certification report must be provided to the user and kept on file. A label indicating the date of certification, the date of the next certification, to what standard the tests were performed and the name of the certifier must be affixed to the exterior of the cabinet. On-site field testing must be performed by experienced qualified individuals. The NSF accreditation program for BSC certifiers provides a list of individuals who have demonstrated their competence by means of written and practical examinations administered by the NSF. The University of Calgary uses NSF-accredited field certifiers only.

6.1.5 Use, Care and Maintenance Follow the manufacturer’s specific instructions for use, care, and maintenance of BSC equipment.

When preparing for work in the BSC:

1. Turn off UV lights if in use and ensure that the sash is in the appropriate position. 2. Turn on fluorescent light and cabinet blower, if off. 3. Check the air intake and exhaust grilles for obstructions. 4. If the cabinet is equipped with an alarm, test the alarm and switch it to the "on" position. 5. Confirm inward airflow by holding a tissue at the middle of the edge of the viewing panel and

ensuring that it is drawn in. 6. Disinfect the interior surfaces with a suitable, non-corrosive disinfectant. If bleach is used follow

up with distilled water to remove residue.


7. Assemble only materials required for the procedure and load them into the cabinet; a. do not obstruct the air grilles; b. set up a clean area, a work area, and a dirty area.

DO NOT OVERFILL THE BSC

8. Wait 5 minutes to purge airborne contaminants from the work area.

When working in the cabinet:

1. Don protective clothing and gloves as appropriate. 2. Perform operations as far to the rear of the work area as possible. 3. Avoid movement of materials and movement of hands and arms through the front access opening

during use; when you do enter or exit the cabinet, do so straight and slowly; allow the cabinet to stabilize before resuming work.

4. Keep discarded, contaminated material to the rear of the cabinet in the dirty area; do not discard materials in containers outside of the cabinet.

5. Do not work with open flames inside the cabinet. 6. If there is a spill during use, surface decontaminate all objects in the cabinet; disinfect the working

area of the cabinet while it is still in operation (do not turn the cabinet off).

Upon completion of the work:

1. Allow the cabinet to run for 5 minutes with no activity. 2. Close or cover open containers before removing them from the cabinet. 3. Surface-disinfect objects in contact with contaminated material before removal from the cabinet. 4. Remove contaminated gloves and dispose of them as appropriate. 5. Wash hands. 6. Don clean gloves, and ensure that all materials are placed into biohazard bags within the cabinet. 7. Using a suitable non-corrosive disinfectant (e.g., 70% ethanol), disinfect interior surfaces of

cabinet; 8. Periodically remove the work surface and disinfect the area beneath it (including the catch pan)

and wipe the surface of the UV light with disinfectant. 9. Turn off the fluorescent light and cabinet blower when appropriate 10. Turn on the UV light if appropriate (do not turn on when people are working close by)

In case of emergency, contact EH&S via Campus Security at 220-5333.

6.1.6 Additional Purchasing Considerations

There are three classes of BSC: Class I, Class II and Class III. Selection of the proper class of BSC requires careful evaluation of the activities to be carried out. Horizontal, clean benches that direct air towards the operator are not biological safety cabinets and must not be used for handling infectious, toxic or sensitizing materials. Only cabinets that meet the National Sanitation Foundation (NSF) Standard No. 49-2002 (independent standard for the design, manufacture and testing of BSCs) and bear an NSF 49 seal should be purchased.

Class I Cabinets

These cabinets have un-recirculated airflow away from the operator that is discharged to the atmosphere after filtration through a HEPA filter. They provide good operator protection but do not protect the material within the cabinet (the product) from contamination.


Class II Cabinets

Class II cabinets are designed for personnel, product and environmental protection. They are designed for work involving microorganisms in containment levels 2, 3 and 4 laboratories and are divided into two types (A and B) on the basis of construction type, airflow velocities and patterns, and exhaust systems.

Within type (A), there are two subtypes, A1 (formerly designated type A) and A2 (formerly designated type B3). Within type (B), there are two subtypes, B1 and B2. Class II cabinets are most commonly used in biomedical research laboratories because of their characteristics.

Class II, Type A1 Cabinets • Cabinet air may be re-circulated back into the laboratory or ducted out of the building by means of a

"thimble" connection (i.e., a small opening around the cabinet exhaust filter housing) whereby the balance of the cabinet is not disturbed by fluctuations in the building exhaust system. The thimble must be designed to allow for proper certification of the cabinet (i.e., provide access to permit scan testing of the HEPA filter).

• Maintain a minimum average face velocity of 0.38 m/s (75 ft/min). • May have positive pressure contaminated ducts and plenums. • Are not suitable for work with low levels of volatile toxic chemicals and volatile radionuclides.

Class II, Type A2 Cabinets

• Cabinet air may be recirculated back into the laboratory or ducted out of the building by means of a "thimble" connection (i.e., a small opening around the cabinet exhaust filter housing) whereby the balance of the cabinet is not disturbed by fluctuations in the building exhaust system. The thimble must be designed to allow for proper certification of the cabinet (i.e., provide access to permit scan testing of the HEPA filter).

• Maintain a minimum average face velocity of 0.5 m/s (100 ft/min). • Have ducts and plenums under negative pressure. • Is suitable for work with minute quantities of volatile toxic chemicals and trace amounts of

radionuclides.

Class II, Type B1 Cabinets • Hard-ducted through a dedicated duct exhausted to the atmosphere after passage through a HEPA

filter; contain negative pressure plena. • Maintain a minimum average face velocity of 0.5 m/s (100 ft/min). • Recirculate 30% of the air within the cabinet. • Suitable for work with low levels of volatile toxic chemicals and trace amounts of radionuclides.

Class II, Type B2 Cabinets • Does not recirculate air within the cabinet. • Maintain a minimum average face velocity of 0.5 m/s (100 ft/min). • Hard-ducted through a dedicated duct exhausted to the atmosphere, 100% of cabinet air, after

passage through a HEPA filter; contain negative pressure plena. • Suitable for work with volatile toxic chemicals and radionuclides.

The exhaust canopy must allow for proper BSC certification. An alarm should be provided that is audible at the cabinet to indicate loss of exhaust flow from the building exhaust system. The cabinet internal fan should also be interlocked to shut down when the building exhaust system fan fails, to prevent pressurization of the cabinet.


Class III Cabinets

Class III cabinets are totally enclosed and gas-tight with HEPA filtered supply and exhaust air. Work is performed with attached long-sleeved gloves. The cabinet is kept under negative pressure of at least 120 Pa (0.5 in. w.g.), and airflow is maintained by a dedicated exterior exhaust system. Class III cabinets protect the worker and the product. They are designed for work with level 4 pathogens and provide an alternative to the positive-pressure suit made for maximum containment laboratories. Cabinet lines consisting of several Class III cabinets (e.g., for centrifuges, animal cages, incubators, refrigerators) and transfer devices joined together are traditionally custom built. Specific guidance on the unique requirements for constructing, installing, certifying and using Class III cabinet lines can be found elsewhere. The exhaust air is double HEPA filtered or treated by HEPA filter and incineration. Removal of materials from the cabinet must be through a dunk tank, double door autoclave or air-lock pass-through for decontamination. Interlock or protocols must be used for the autoclave and pass-through doors to prevent both doors from being open at the same time.

6.1.7 Moving BSCs

Moving a BSC to a new location requires the following steps arranged by the laboratory: • A qualified contractor has to perform a gaseous decontamination with an appropriate decontaminant. • Gas connections have to be disconnected (arrange for the gas disconnection through the i-request

system). • The move has to be performed by a qualified and insured contractor. • The new location has to be clearly identified and adequate access needs to be provided. • After the installation, the BSC has to be certified by a qualified and certified contractor.

EQUIPMENT AND PROCESS

CONTAINMENT TECHNIQUES


Revision #: NEW Part: 6.2 Additional Equipment Revision Date: --


6.2 ADDITIONAL EQUIPMENT

In addition to Biological Safety Cabinets (BSC), the following equipment may be used in a biohazardous materials laboratory. All equipment must be used and maintained in a safe and proper manner, and in accordance with manufacturers’ specifications.

Centrifuges Be aware of the potential hazards associated with biohazardous materials in case of aerosol production and leakage during centrifugation. A worker may be exposed to aerosols dispersed into the air from leaks. Additional precautions are recommended to be taken to prevent exposure to these materials. Special considerations for biohazardous materials include: • All centrifuge tube containers must only opened in a biosafety cabinet; and • All centrifuges should be considered highly contaminated equipment unless centrifugation occurs in a

secondary container that is aerosol-proof. • Centrifuges must be decontaminated after every use.

Cell Sorters Because viable biologic specimens can contain infectious agents, precautions need to be taken to prevent the exposure of operators of flow cytometers to biohazards arising from the use of these instruments. The major source of increased aerosol production on cell sorters is a clogged sort nozzle. Samples should be prepared properly to minimize the formation of cell clumps. Cell sorters also create aerosols when the undeflected centre stream and the side streams splash into receptacles. The following guidelines may be used to prevent exposures to pathogens contained in the sort samples: • Only experienced flow cytometry operators should perform potentially biohazardous sorts; • Aerosols are generally contained within the sorting chamber when the door is properly closed and the

interlock is engaged; and • Aerosol trapping devices are available from most manufacturers.

It is recommended that all laboratory manipulations are conducted inside a BSC, however, cell sorters do not generally fit inside BSC and specimens must be handled on an open bench. It is recommended that all cell sorting be conducted in level 2 containments labs following level 3 work procedures. • Personnel must be trained in proper procedures and strictly adhere to these techniques;


• Handle all unfixed specimens as if infectious. If samples are fixed, appropriate and reliable methods must be used to inactivate the potentially biohazardous agents;

• Whenever possible, the sorter operator should consider vaccination again the potential infectious organism that may be present in the samples;

• Recommended PPE includes: disposable, wrap-around, solid front, long sleeved laboratory coat; examination gloves; HEPA particulate filter respirator; and safety goggles;

• Test the proper operation of the sort mechanism and the stability of the sort streams and droplet break-off each time immediately before sorting a potentially biohazardous specimen; and

• After each sort decontaminate the sorter with appropriate disinfectant.

Microtomes A microtome is a mechanical instrument used to cut biological specimens into very thin segments for microscopic examination. Microtome blades are extremely sharp, and should be handled with great care. Safety precautions should be taken in order to avoid any contact with the cutting edge of the blade and to prevent exposure to solvents and biohazardous materials. Special considerations for biohazardous materials: • Prions are not deactivated by the standard microtome preparation steps. You must wear gloves and

use appropriate decontamination procedures when samples may contain prions.

Freeze Dryers Freeze drying (also known as lyophilization) is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport.

French Presses The French press (also known as French pressure cell press), is an apparatus used in biological experiments to disrupt the plasma membrane of cells by passing them through a narrow valve under high pressure. The press uses an external hydraulic pump to drive a piston within a larger cylinder that contains the sample. The highly pressurized solution is then squeezed past a needle valve. Once past the valve, the pressure drops to atmospheric pressure and generates shear stress that disrupts the cells. The major source of aerosol production is the clogging of the valves. Only experienced and knowledgeable operators should use this equipment.

NOTE: Clean air benches and fumehoods must not be used with biohazardous materials.


http://en.wikipedia.org/wiki/Dehydration

http://en.wikipedia.org/wiki/Preserve

http://en.wikipedia.org/wiki/Cell_disruption

http://en.wikipedia.org/wiki/Plasma_membrane

http://en.wikipedia.org/wiki/Cell_%28biology%29

http://en.wikipedia.org/wiki/Hydraulic

http://en.wikipedia.org/wiki/Piston

http://en.wikipedia.org/wiki/Needle_valve

http://en.wikipedia.org/wiki/Atmospheric_pressure

http://en.wikipedia.org/wiki/Shear_stress


6.3 Safety-Engineered Medical Sharps A “safety-engineered medical sharp” is a medical sharp that is designed to, or has a built-in safety feature or mechanism that eliminates or minimizes the risk of accidental parenteral contact while or after the sharp is used; parenteral contact means piercing mucous membranes or the skin.

Specially designed medical sharps e.g. hollow-bore needles, suture needles, scalpels, etc. reduce the risk of needlestick injuries and other puncture wounds from contaminated sharps. Self-sheathing needles have a built-in sheath or sleeve that extends to cover the needle. Retractable syringes are designed so the needle can be pulled up inside the syringe. Needleless systems use threaded ports on IV tubing, so healthcare workers can remove the needle from the syringe after drawing up medication, and then simply screw the syringe directly into the port. Disposable safety scalpels have a built-in sheath that covers the blade between use and disposal, and suture needles for sewing tissues other than skin are available with blunted tips.

New Requirements The 2009 revision of the Alberta Occupational Health and Safety Act, Code and Regulation introduces new requirements for safety-engineered medical sharps as described in Part 35: Health Care and Industries with Biological Hazards (Sub-section 525). Effective July 1, 2010, employers must provide and ensure that any medical sharp is a safety-engineered medical sharp. This Requirement does not apply if:

• Use of the required safety-engineered medical sharp is not clinically appropriate; or • The required safety-engineered sharp is not available in commercial markets.

The employer must establish safe work procedures for the use and disposal of medical sharps if a worker is required to use or dispose of a medical sharp. The safe work procedures must be in writing and available to workers. The procedures must include a discussion of:

• The hazards associated with the use and disposal of medical sharps; • The proper use and limitations of safety-engineered medical sharps; • Procedures to eliminate accidental contact with medical sharps; and • And any other relevant information.

SAFETY-ENGINEERED MEDICAL SHARPS

Section: 6 Date of Issue: 2010.02.16 Issued By: Environment, Health &Safety

Part: 6.3 Safety-Engineered Medical Sharps Revision #: NEW Revision Date: --



The purpose of the procedures is to limit the possibility of workers coming into contact with medical sharps that could cause a cut or puncture wound. Workers must be trained in the safe work procedures so that the procedures are understood and followed. Workers are required to use and dispose of medical sharps in accordance with the training they have received by the employer. Further information can be found at: http://www.employment.alberta.ca/documents/WHS/WHS-LEG_ohsc_p35.pdf Photo courtesy of: http://www.worksafebc.ca/publications/health_and_safety/posters/assets/pdf/safety_medical_sharps.pdf

TRANSPORTATION OF BIOHAZARDOUS

MATERIALS


Revision #: NEW Part: 7.1 Transportation Requirements Revision Date: --


7.1 TRANSPORTATION REQUIREMENTS

The transportation of infectious substances is an essential part of routine laboratory procedures in both research and diagnostic settings. Samples must be transported by road and/or air to assist researchers collaborating with other researchers at removed locations, or to carry out primary diagnostic tests on samples obtained from ill patients. Although there has never been a reported case of illness associated with a transportation accident involving an infectious substance, transportation accidents involving infectious substances have occurred. Therefore, it is important that infectious substances be packaged and transported according to tested and approved methods.

7.1.1 Movement of Hazardous Materials within Buildings

Please refer to the Safety Bulletin: Movement of Hazardous Materials within Buildings at: http://www.ucalgary.ca/safety/files/safety/MovementofHazardousMaterialsWithinBuildings.pdf The transportation of infectious substances within Canada is regulated by the Transportation of Dangerous Goods Regulations (SOR/85-77), administered by Transport Canada. Transport Canada defines the labelling, packaging and documentation requirements necessary for shipping infectious substances, including diagnostic specimens, within Canada. Their regulation also requires that any individual transporting an infectious substance be trained in the transportation of dangerous goods (infectious substances). More information regarding the transportation of infectious substances within Canada can be obtained by calling Transport Canada, Dangerous Goods Standards, at (613) 990-1059, by writing to them at Place de Ville, Tower C, 330 Sparks St., 4th Floor, Ottawa ON K1A 0N8, or by visiting the Transport Canada Dangerous Goods Website at: http://www.tc.gc.ca/civilaviation/commerce/dangerousgoods/

7.1.2 Air Transportation

The air transportation of infectious substances internationally is regulated by the International Civil Aviation Organization (ICAO). As the majority of carriers (both passenger and courier/cargo) around the world are members of this organization, anyone shipping infectious substances internationally is likely subject to ICAO regulations. The ICAO regulations define the labelling, packaging and documentation requirements necessary for international shipping of infectious substances by air. It also requires that any individual transporting an infectious substance be trained in the transportation of dangerous goods (infectious substances). The ICAO requirements are based upon the United Nations Recommendations on the Transportation of Dangerous Goods. For further information regarding international shipping requirements, please contact the ICAO Canadian representative directly: Judith Code, Chief, Dangerous Goods Standards, Commercial and Business Aviation, Transport Canada, at (613) 990-1060 (mailing address as indicated


http://www.ucalgary.ca/safety/files/safety/MovementofHazardousMaterialsWithinBuildings.pdf

http://www.tc.gc.ca/civilaviation/commerce/dangerousgoods/

for Transport Canada above). Shipping infectious substances by air also falls under the Dangerous Goods Regulations (DGR) of the International Air Transport Association (IATA). These regulations set out all the ICAO mandates and the airline industry’s universal rules on how to safely package and transport infectious substances. A copy of the DGR may be obtained from IATA by calling 1-800-716-6326 or through their Website at: http://www.iata.org/ Note: The risk groups described in section 5.1 do not apply to air transport. To avoid delays in shipments by air ensure the appropriate classification is obtained prior to sending the material.

7.1.3 Importation, Transfer and Containment of Animal Pathogens The Health of Animals Act, 1990, and the Health of Animal Regulations give the CFIA the legislative authority to control the use of imported animal pathogens and pathogens associated with reportable animal diseases. These include materials of animal origin that contain potential pathogens. Please refer to the Health of Animals Act and the Regulations for complete information. Permits are required for the importation of all animal pathogens into Canada. In the case of pathogens that affect both humans and animals, import permits are required from both Health Canada and the CFIA. If an agent is brought into Canada under an import permit that restricts its distribution, further approval must be obtained from the CFIA before transferring the agent to another location. The CFIA also establishes the conditions under which animal pathogens will be maintained and work will be carried out. It is necessary to consider not only the risk to human health but also the level of containment needed to prevent escape of an animal pathogen into the environment, where it may constitute a risk to any indigenous animal species. The CFIA publication Containment Standards for Veterinary Facilities outlines the minimum design, and physical and operational requirements for Canadian laboratories and animal facilities that import and work with animal or zoonotic pathogens. Laboratories that apply to import animal or zoonotic pathogens must demonstrate that they meet these requirements before the CFIA can issue an import permit. Animal pathogens, including pathogens that affect both humans and animals, under the control of the CFIA are listed in a database maintained by the Biohazard Containment and Safety Division, CFIA. This is a dynamic list that is continuously amended to include emerging pathogens that may require restriction. Animal pathogens that are considered nonindigenous to Canada form a portion of this database and are severely restricted. For each animal pathogen, the CFIA must be consulted for its importation, use and distribution.


http://www.iata.org/

BIOHAZARD WASTE DISPOSAL


Revision #: NEW Part: 8.1 Waste Disposal Requirements Revision Date: --


8.1 WASTE DISPOSAL REQUIREMENTS Inquiries regarding waste disposal should be directed to Hazardous Materials Services [email protected] . This unit is part of Supply Management.

8.1.1 Clean Glass and Plastics The following items are not accepted in the blue glass buckets as per existing policy: • Any items that have closed lids on them (bottles, tubes, vials, etc.); • Garbage (paper, foil, metal, etc.); • Sharps (needles, scalpels, etc.); • Liquids in containers or in the bucket itself; • Chemical contamination of any kind; • Containers with labels not defaced; and • Mercury thermometers.

A copy of the policy can be found at: http://www.ucalgary.ca/safety/files/safety/SOPHazardous%20MaterialsWasteDisposal.pdf

8.1.2 Yellow Biomedical Waste Containers All Biomedical Waste containers that meet the following requirements are acceptable for offering for transport and disposal. Provided all Transportation of Dangerous Goods (TDG) requirements are met.

1. Disposal items should be restricted to the following: • • •

•

All metal sharps; All blood or items visibly contaminated with blood; Glass sharps and broken glass contaminated with biohazards if chemical decontamination impossible; and Glass Pasteur pipettes.

2. The maximum weight of the pail is 15 kg.

3. Container Maximum Content Volume

• Containers WITHOUT an indicated fill-line should be filled to not more than 3/4 of capacity; and

• Containers WITH an indicated fill line should be filled to the fill line only.

4. Lids have to fit the container and need to be securely in place and not be bulging.



http://www.ucalgary.ca/safety/files/safety/SOPHazardous MaterialsWasteDisposal.pdf

5. The following information is required on the container lid • Building; • Room Number; • Telephone Number; • Contact Person's Name; and • Principal Investigator’s Name.

6. The pails must be inspected by the laboratory staff for blood, other spills & exterior contamination, and sharps protruding through the sides, top, or bottom of the container, prior to disposal.

7. Biomedical waste containers that do not meet the above criteria will not be picked up. The

laboratory will be responsible to correct any of the deficiencies. Inquiries regarding waste disposal should be directed to Hazardous Materials Services [email protected] . Hazardous Materials Services is a division of Business Operations.



LABORATORY DECOMMISSIONING AND DECONTAMINATION


Revision #: NEW Part: 9.1 Decontamination and Close-Out Procedures Revision Date: --


9.1 DECONTAMINATION AND CLOSE-OUT PROCEDURES

9.1.1 Decontamination Procedures It is a basic biosafety principle that all contaminated materials be decontaminated prior to disposal. Decontamination includes both sterilization (the complete destruction of all microorganisms, including bacterial spores) and disinfection (the destruction and removal of specific types of micro-organisms). Decontamination procedures for waste disposal, for removing materials, equipment, samples from containment zones, for laundry, for contaminated surfaces and rooms, etc. represent a critical containment barrier. All contaminated materials must be decontaminated before disposal or cleaning for reuse. Failure in the procedure can result in the unintentional release of agents from the containment facility. It is the responsibility of each facility to see that proper procedures are followed and that containment is not breached. The choice of method is determined by the nature of the material to be treated. This may include, but is not limited to: • laboratory cultures, stocks and clinical specimens; • laboratory equipment, sharps and protective clothing; and • other items that have come into contact with infectious materials.

Laboratory bench tops and surfaces are to be decontaminated after any spill of potentially infectious materials and at the end of each working day. Laboratory rooms and large pieces of equipment may also require decontamination (i.e., prior to servicing, maintenance, transfer to other settings or reassignment). It is the responsibility of all laboratory workers to ensure the effective use of products for decontamination of materials, equipment, and samples from containment zones; of surfaces and rooms; and of spills of infectious materials. Written procedures must be available for each specific decontamination method being used. Employees must be trained in all decontamination procedures specific to their activities and should know the factors influencing the effectiveness of the treatment procedure, as discussed briefly below. Decontamination processes may include: • Autoclaving; • Chemical Disinfection; • Gaseous Decontamination of Rooms (AKA Fumigation);


• Liquid Effluent Treatment Systems; • Irradiation; and • Incineration.

All decontamination and waste management procedures must be in accordance with applicable federal, provincial, and municipal regulations. All records of efficacy testing and logs of decontamination cycles must be kept on file and available for inspection as necessary.

9.1.2 Laboratory Check-Out It is recommended that the principal investigator who moves or shuts down a laboratory begin the check-out procedures at least 4 weeks prior to leaving. A checklist and the recommended timeline are outlined in the Procedures for Laboratory Check-Out document. All Principal Investigators, Graduate Students, Post Doctoral Fellows and Collaborative Researchers must follow the procedures. The University of Calgary’s Procedures for Laboratory Close-Out can be found in the University of Calgary’s Laboratory Safety Manual and on the EHS website.



10.1 PRION GUIDELINES

10.1.1 Introduction All PIs who wish to store, handle or use prion material require approval from the Biosafety Committee. For laboratories which have already registered their biohazardous materials, the biohazardous registration will have to be updated and a new approval will be issued from the Biosafety Committee. The following guidelines were complied from resources including CFAI’s Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents and additional references as listed in Section 12. A prion can be defined as small proteinaceous infectious particles which resist inactivation by procedures that modify nucleic acids including irradiation, boiling, dry heat and chemical. These unconventional infectious agents are responsible for certain fatal degenerative diseases of the central nervous system (CNS) and in both humans and animals. Prion diseases are often called transmissible spongiform encephalopathies. Specific examples include: • Scrapie: sheep , goats; • TME (transmissible mink encephalopathy): mink; • CWD (chronic wasting disease): mule deer, elk; • BSE (bovine spongiform encephalopathy): cattle; and • CJD (Creutzfeldt-Jakob disease): humans.

Laboratory activities involving the use of prions or tissues containing prions have been increasing in both animal and human health research. Due to the limiting knowledge of prion diseases, their infectious nature, and unconventional decontamination procedures, conservative precautionary measures must be implemented while working with these agents to minimize both occupational and environmental exposure risk.

10.1.2 Prion Biosafety Considerations Prions are manipulated at Biosafety Level (BSL-2 or BSL-3), depending on the research being conducted, the type of tissue handled (i.e. human prions and BSE prions), the nature of the manipulation and the amount of material handled. Most human prions are treated as BSL-3 under most experimental conditions. Once human prions are passed to mice, the properties of the prions are altered and the experiments can then be conducted at BSL-2 (unless mice express human or bovine transgenes). A hazard assessment should be conducted with the assistance of the UofC Biosafety Officer ([email protected] ) to determine the level of containment that is appropriate on a case-by-case basis.

SPECIAL CONSIDERATIONS


Revision #: 1 Part: 10.1 Prion Guidelines Revision Date: 2008.12.19



The highest concentration of prions is found in the central nervous system (CNS) and its coverings, and extra precautions must be used when handling CNS samples. There is the possibility that prions may be found in the spleen, thymus and lymph nodes. Unfixed samples of brain or spinal cord, as well as other tissues known to contain human prions should be handled at BSL-3. With regards to BSE prions, it is also recommended that animal tissue samples (e.g., brain, spinal cord) known or strongly suspected to contain prions be handled at BSL-3. Formaldehyde or formalin-fixed, glutaraldehyde-fixed and paraffin-embedded tissues, particularly of the brain, remain infectious for long periods. They should be handled as fresh materials from fixation through embedding, sectioning, staining and mounting on slides, unless treated with 95% formic acid. To date, there are no reported laboratory-acquired prion infections. The primary hazard is from contamination through accidental parenteral inoculation, an existing wound, or splashing of mucous membranes (i.e. mouth, nose and eyes). The following precautions should be implemented to minimize the risk of exposure: • Cuts and punctures should be avoided by minimizing the use of sharps including knives, scalpels,

blades and needles; • Personnel protective equipment should include:

• Splash goggles; • Fluid barrier masks or face shield if risk of splashes or sprays; • Disposable latex or nitrile gloves; • Cut resistant gloves underneath disposable latex or nitrile gloves when using sharps other than

needles (i.e. blades, scalpels, etc.); and • Wrap-around or solid front gowns.

• Wherever possible, the laboratory and equipment used for work with prions should be dedicated to that task alone;

• All employees should be informed and aware that prion research is being conducted in the lab; • The entrance to the lab should allow for the separation of PPE/lab clothing and staff clothing; • An emergency response plan should be developed, posted and communicated to all employees in the

event of an exposure; and • Procedures should be in place for the effective decontamination of all waste, re-usable equipment,

surfaces and other lab space.

10.1.3 Prion Work Procedures The following applies to research and diagnostic laboratory application with prion-risk materials only. Guidelines for use of prion-risk materials in conjunction with live animals should be developed if necessary. The following specific measures should be implemented for all work with prion-risk materials: • Access to the laboratory must be restricted to trained personnel when work is being conducted on

tissue. • Personnel working with prion-risk materials must complete the Introduction to Biosafety Training

provided through EH&S, as well as complete on-site/job-specific training relative to the nature of the prion in use, routes of transmission, and specific hazards of the tissue handling process. Written procedures and training records should be included in the Laboratory Safety Manual and be available upon request.

• Personnel must wear all appropriate PPE (i.e. gloves and gowns) while handling tissues that are potentially contaminated. All protective clothing must be removed before leaving the laboratory.

• All fixed, non-fixed, or frozen tissues must be contained within watertight containers. Containers must be individually labelled or placed in a secondary container (i.e., a tray with sides).


• Sonication or homogenization of tissues must be performed in a properly certified Class II biosafety cabinet.

• Microtome blades and knives used for cutting tissue must be cleaned with an instrument that does not put the hand or finger of the operator in or near contact with the blade.

• The following provisions for decontamination of wastes, reusable instruments and contaminated surfaces must be followed to assure effective inactivation of prions: • Liquid waste may be treated by mixing with bleach for a final concentration of 2% available

chlorine for one hour. This waste should be stored in a chemical fume hood for the duration of the treatment period. After the treatment period, liquid waste may be neutralized and discharged to the sewer by way of the lab sink, or disposed of as liquid chemical waste.

• Contaminated surfaces that can withstand the treatment should be cleaned using the following recommendations: first clean surface thoroughly, then flood surface with 2% available chlorine or 2N NaOH for 1 hour at room temperature, then rinse with water.

• Contaminated surfaces that cannot withstand NaOH/HCl treatment are cleaned with 10% household bleach, allowing 30-60 minutes contact time, and then washed with clear water.

• Contaminated dry waste is autoclaved at 134º C for 1 hour, then placed in a regular, black bag for disposal as non-regulated solid waste. If an appropriate autoclave is not available, this waste may be picked up for incineration (incineration at 850º C is highly recommended).

• If feasible, sharps waste should be autoclaved at 134-138º C for 1 hour before being picked up as medical waste for incineration. Prion-contaminated sharps waste must be identified as “prion contaminated sharps - for incineration only” on the hazardous waste pickup request to assure incineration of these materials.

• Intact skin exposure to prion-risk materials should be followed by washing with 1N NaOH or 10% bleach for 5 minutes, followed by extensive washing with water. For needle sticks or lacerations, gently encourage bleeding, wash with warm soapy water, rinse, dry and cover with a waterproof dressing. In the event of a splash to the eye, rinse the affected eye with copious amounts of water or saline only. In the event of a splash or puncture, the exposed individual should then report to Campus Security at 220-5333.

• The Principal Investigator (PI) must assure that all spills or exposures involving prion-risk materials are managed with the proper procedures. Additionally, these events should be reported to Campus Security and EH&S for follow-up and assistance with actions to reduce future occurrences.

SPECIAL CONSIDERATIONS


Revision #: NEW Part: 10.2 Sheep in Research Revision Date: --


10.2 SHEEP IN RESEARCH The following work procedures were adapted from The Public Health Agency of Canada’s Guidelines for Biomedical Facilities using sheeps as research animals (December 2000), which can be found at: http://www.phac-aspc.gc.ca/ols-bsl/animres_e.html

10.2.1 Introduction

Q fever is a zoonotic disease caused by the rickettsial organism Coxiella burnetii. Cattle, sheep and goats are the most common reservoirs of this infection and less commonly in cats, dogs and rabbits. C. burnetii may be present in placenta tissue, birth fluids or excreta from infected animals. The organisms are also highly resistant to heat, dessication (drying out of living organisms), many common disinfectants and can persist for months in contaminated soils and wood.

Other zoonoses associated with sheep in a laboratory setting include:

• Brucellosis; • Campylobacteriosis; • Chlamydiosis; • Cryptosporidiosis; • Dermatophytosis; • Echinococcosis; • Ectroparasitism; • Giardiasis; • Leptospirosis; • Orf; • Salmonellosis; and • Tuberculosis.

Human infection usually occurs through inhalation of contaminated dusts and aerosols generated from infected animals, their waste products, placental tissues and fluids, and contaminated straw or bedding. Only a single inhaled organism may be sufficient to cause infection in a susceptible host. Approximately 50% of all people infected with C. burnetii show signs of clinical illness. Atypical pneumonia will develop in approximately 50% of clinical cases and the liver, lung, and brain may be targeted by the infection. Mortality is very low (less than 1%) and most patients will recover to good health within several weeks without any treatment. Persons at risk (i.e. those with valvular heart disease, persons who are immunosuppressed, pregnant women) should be advised of the risk of serious illness that may result from Q fever. Chronic Q fever, characterized by infection that persists for more than 6 months is uncommon but is a much more serious disease.


Exposure to naturally infected, often asymptomatic sheep and their birth products is a documented occupational hazard in biomedical facilities using sheep as research animals. Institutional outbreaks of Q fever have occurred not only in those researchers working directly with sheep, but also in persons such as janitors, secretaries and others who worked in the same facility and who had no direct contact with the animals.

The protective efficacy of Q fever vaccines for human use has been demonstrated and used successfully in Australia. However, this vaccine is not commercially available in Canada. Vaccination of persons at high risk of exposure who are without demonstrated sensitivity to Q fever antigen is currently only available in Canada through the Special Access Program (SAP) administered by the Therapeutic Products Programme of Health Canada. To initiate a request for vaccine a physician may write, telephone, fax or email the SAP:

Special Access Programme Therapeutic Products Directorate Holand Cross, Tower "B" 1600 Scott St., 3rd floor Ottawa, ON K1A 1B6 tel: 613-941-2108 fax: 613-941-3061 www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html

An overview of many aspects of Q fever including information on the organism, disease, signs and symptoms in humans, diagnosis, and treatment can be found at the Centers for Disease Control and Prevention's Q fever web page as follows: www.cdc.gov/ncidod/dvrd/qfever .

Included on the suggested reading page is a list of references and reports on cases associated with institutional use of sheep in research.

10.2.2 Scope

The first line of defence is to reduce the risk of bringing infected animals into the research facility. Unfortunately, it has been established that seronegative sheep can still shed rickettsiae. Until new testing methods such as polymerase chain reaction can be well validated, it would be premature to recommend the use of animals documented to be serologically Q-fever free as a safe alternative to containment precautions. The risk of Q fever in a flock or herd can however be dramatically reduced through the use of a diligent surveillance and certification program. While no flock can be guaranteed to be and stay "Q-fever free" an ongoing surveillance program can markedly reduce the likelihood of infection. The use of open flocks with unknown Q fever status should be avoided.

These Guidelines for Biomedical Facilities using sheeps as research animals are intended to specifically address the task of containing pregnant and periparturient research animals where the occupational hazard is well documented. The use of males or nonpregnant female animals does reduce the risk and the specific containment precautions outlined below are not applicable. However, it is still advisable to purchase all animals from flocks with a well-documented Q fever surveillance program to reduce the risk even further.

Farms, barns and other open animal husbandry or farm facilities present different public health problems for which these Guidelines are not specifically applicable. Where possible, the separation of research facilities using sheep, especially pregnant ewes, from buildings housing unassociated research and teaching activities, laboratories, hospitals and patient areas is preferable. Such physical separation is not always possible. Some flexibility is provided for in the Guidelines with respect to the facility design requirements where physically separate facilities are used.

These Guidelines are not designed for large animal facilities specifically manipulating C. burnetii infected animals. Such studies must be performed in a level 3 containment facility that is designed and operated in accordance with the Containment Standards for Veterinary Facilities.



http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html

http://www.cdc.gov/ncidod/dvrd/qfever

These Guidelines were developed in consultation with experts in this field, including those in the medical community currently working with sheep.

10.2.3 Operational Practices

The following operational practices are required:

• A documented procedural manual for the sheep facility outlining the safety and containment practices (e.g. entry/exit protocols for persons, animals, equipment, samples, waste) should be written and followed. General protocols should be supplemented with protocols specific for each project in process. Emergency procedures for entry/exit, air handling failure, fire, animal escape and other emergencies should also be written.

• Staff, including animal handlers and maintenance personnel, should receive training on the potential hazards associated with the work involved, the necessary precautions to prevent exposure to Q fever, the practices to prevent the release of infectious agents from the facility, the operational protocols for the project in process, and emergency procedures. Staff should show evidence that they understood the training provided. Training should be documented and signed by both the employee and supervisor and kept in the Laboratory Safety Manual and be available upon request.

• Staff working with and around sheep and sheep products (including bedding, excrement, birth products, and animals or animal tissues) should be enrolled in Biosafety Courses provided by EH&S.

• Only persons meeting specific entry requirements should enter the sheep facility unless the facility has been appropriately decontaminated. Access should be restricted to authorized personnel only. Where necessary, maintenance and service staff may enter the unit under other conditions (e.g. without decontamination) when accompanied by trained facility staff and provided with appropriate personal protective equipment.

• All accidents, overt or potential exposures to infectious materials, breaches of containment, seroconversions, suspected cases of Q fever, and other hazardous occurrences should be reported immediately to Campus Security at 220-5333 and EH&S. Incident reports should also be completed and submitted to EH&S.

• Researchers using sheep should follow good microbiological practices and perform a risk assessment designed to minimize contact with infectious agents, minimize the creation of infectious aerosols, and reduce the opportunity for exposure of staff and the environment.

• Staff working in the containment area should have general knowledge of the physical operational and design features of the facility (e.g. negative air pressure gradients, directional airflow patterns, alarm signals for air handling failure).

• Traffic flow patterns from clean to dirty areas should be established and adhered to (i.e. move from least to most contaminated areas). Where this is not possible, operational procedures should be in place (e.g. disinfection/decontamination barriers) to prevent the transfer of contamination to clean areas of the facility.

• Staff entering the sheep facility should wear dedicated protective clothing (i.e. scrubs) to that area. Additional protective clothing may also include solid-front or wrap-around gowns, coveralls, gloves, boots, and disposable shoe covers. Outer gowns should have a liquid proof protective surface. None of this clothing should be worn outside the designated area and should be decontaminated prior to laundering and/or disposal.

• For non-vaccinated staff and those with no demonstrated immunity to Q fever, an N-95 respirator should be used when attending parturient ewes or during surgical procedures that may generate infectious aerosols.

• At the end of high-risk procedures (e.g. when attending parturient ewes or during surgical procedures), staff leaving the area should shower in a designated area before going anywhere else, particularly if primary clothing becomes soiled with potentially infected material. Entry into low-risk areas of the facility with no direct sheep contact (i.e. to read chart records) would not necessitate a shower on exit providing protocols are in place to prevent contamination of such areas.

• Potentially contaminated items (including paperwork) to be removed from sheep holding and surgery areas should be decontaminated on exit from the facility. Alternatively, such items can be double-bagged or placed in impervious containers for processing in a central decontamination area. The exterior surface of such bags/containers and transport containers containing items for further study


(e.g. tissue samples) should be disinfected on exit from the facility. Items from low-risk areas of the facility with no direct sheep contact (ie. chart records) can be removed without further decontamination provided they have been handled in a manner that prevents their contamination.

• At the end of the experiment all supplies remaining in the animal room (e.g. feed, bedding) should be removed and decontaminated.

• Animal carcasses and tissues should be incinerated or processed through new technology proven to be effective (e.g. tissue autoclave).

• Potentially contaminated items to be removed from the facility and surfaces in surgical or laboratory areas can be disinfected with a fresh 1:100 dilution of household bleach, 5% solution of H2O2, or a 1:100 dilution of LysolR 3.

• Areas that have held parturient ewes should be cleaned and decontaminated at the end of an experiment (i.e. when practical and not necessarily at the end of an experiment involving only one of several sheep in the facility) using a fresh 1:100 dilution of household bleach, 5% solution of H2O2, or a 1:100 dilution of LysolR 3. Decontamination can also be achieved by spraying with a liquid formaldehyde disinfectant or fumigating with paraformaldehyde.

• Smoke testing (i.e. with a smoke pencil) should be done periodically by staff to verify correct airflow and results documented.

• Water seals in floor drains and other drainage traps should be maintained (i.e. through regular usage and/or by filling traps in areas that are not being used).

• Sheep should never be transported through hospital patient-care areas. Transfer of sheep through corridors and other areas not specifically designated as part of the sheep facility should be done using containment transport carts.

• An effective rodent and insect control program should be maintained.

10.2.4 Physical Facilities

In addition to the requirements provided below, the facility requirements and environmental conditions suitable to sheep as recommended by the Canadian Council for Animal Care (CCAC) should be followed.

• The sheep facility should be located away from areas that are open to unrestricted personnel traffic within the building.

• Animal entry to the facility should be provided away from public entrances. • Entry to the sheep facility should be labelled with appropriate signage (i.e. biohazard identification,

name and phone number of contact person, specific entry requirements). • Office areas should be located outside of the sheep facility. Paperwork areas for researchers and

animal handlers are permitted within the facility but should be located away from animal holding and surgery areas.

• A double-door entry/egress to sheep holding and surgery rooms should be provided with an area designed to don protective clothing dedicated to the sheep facility. A protocol should be in place to prevent the opening of both entry doors at the same time, or, preferably be equipped with interlocking doors. The exterior entry door should control access by means of a key lock, card key, or proximity reader.

• The area should be designed to facilitate cleaning and disinfection. Interior surface coatings (ie. floors, walls, ceilings) should be impervious to liquids and chemicals, and penetrations in the containment barrier should be sealed, to facilitate cleaning and decontamination of the area.

• Any windows, although not recommended, should be resistant to breakage and sealed shut. • A handwashing sink with hands-free capability should be provided near the exit door. • The sheep facility should be maintained at negative air pressure with respect to adjoining corridors and

facilities. Visual monitoring devices that confirm directional inward airflow should be located at the entry to the sheep facility.

• The exhaust air should not be recirculated to any other areas of the building unless it has passed through HEPA filtration.

• Sealed ductwork should be used where sheep facilities are not physically separated from other building activities (i.e. potentially contaminated ductwork passes through occupied areas).


http://www.ccac.ca/

• Exhaust air from the sheep facility should be HEPA filtered where physically separate sheep facilities are not used. Filtration of the exhaust air should be located as near as practicable to the source in order to minimize the length of potentially contaminated ductwork, or, alternatively, sealed ductwork should be considered

• A ventilation control system and equipment should be installed where physically separate sheep facilities are not used. (e.g. redundant exhaust fan, supply isolation damper to prevent sustained positive pressurization and backdraft of contaminated air). An alarm system to notify personnel of ventilation systems failure should be installed.

• The performance of critical containment components (e.g. testing of HEPA filters, integrity of containment perimeter, verification of HVAC control systems and alarms) and operational parameters should be verified prior to operation. Re-verification should also be performed as required by operational experience. Detailed records of the verification process and test results should be maintained.


DEFINITIONS


Revision #: NEW Part: 11.1 Definitions Revision Date: --


Aerosol – a suspension of solid or liquid particles in the air. Microbial aerosols or bioaerosols are air-suspended particles containing microorganisms and can range in size from less than one micrometer to one hundred micrometers. Aerosolization – the production of an aerosol by applying energy to a liquid or a solid. The higher the applied energy, the higher the number of created aerosols, and the smaller the aerosols that are created. Autoclave – a piece of equipment used to apply superheated steam under pressure; commonly used for the sterilization of biohazards through the destruction of the macro-molecular structure. Biohazardous materials (or Biohazards) – are disease causing organisms, prions and biological toxins that are capable of causing human or animal disease as well as materials potentially containing such disease-causing organisms, prions or biological toxins such as human and certain animal tissues, cell lines, and body fluids. Biological and Toxin Weapons Convention – bans the development, production, stockpiling, acquisition and retention of microbial or other biological agents or toxins, in types and in quantities that have no justification for prophylactic, protective or other peaceful purposes. It also bans weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict. Biological Indicators – refers to organisms, species or community whose characteristics show the presence of specific environmental conditions. For sterilization control, biological indicators are spore strips or spore containing ampoules chosen to be least affected by the sterilization process. The destruction of the spores indicates the efficacy of the sterilization process. Biological Safety Cabinet (BSC) – a ventilated cabinet which uses a variety of combinations of HEPA filtration, laminar air flow and containment to provide personnel, product and environmental protection against particulates or aerosols from biohazardous materials. Biosafety – the prevention of Laboratory Acquired (Associated) Infections (LAIs) through the containment of biohazardous substances through safe work practices and techniques, as well as engineering, administrative and operational controls. Biosafety Committee – an advisory committee to the Vice-President (Research), ensuring the effectiveness of the biosafety program. It is responsible for developing policies and procedures to be followed when handling biohazardous materials in accordance with the applicable guidelines, and relevant Federal and Provincial standards, acts and regulations, and municipal bylaws. Biosafety Officer (BSO) – responsible for providing assistance to, and is a member of, the UofC Biosafety Committee whose duties shall include, but are not limited to administering, implementing, and enforcing the Biosafety Program. Bloodborne Pathogen – a bloodborne pathogen is a microorganism (bacteria, virus, etc.) that lives in the bloodstream and can cause disease in humans.


Canadian Food Inspection Agency (CFIA) – created in April 1997; consolidates the delivery of all federal food, animal and plant health inspection programs of the federal government. Cell Sorter – see Flow Cytometer Centrifuge – a mechanical device that uses centrifugal or rotational forces to separate substances of different densities, such as solids from liquids or liquids from other liquids. Emergency Response Plan (ERP) – a detailed plan that describes the logistics and reporting requirements in the event of injury, fire, or spills. Fixed Specimens – cells that are chemically treated to immobilize, kill and preserve them making the cells permeable to staining reagents. Flow Cytometer - a scientific instrument for counting, examining and sorting microscopic particles suspended in a stream of fluid. Flow Cytometry – a technique for counting, examining and sorting microscopic particles suspended in a stream of fluid. Analysis of the physical and/or chemical characteristics of single cells is completed by observing the flow through an optical and/or electronic detection apparatus. Freeze Drying (or lyophilization) – a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Freeze drying works by freezing the material and then reducing the surrounding pressure and adding enough heat to allow the frozen water in the material to sublime directly from the solid phase to gas. Fumigation – the application of smoke, vapour, or gas for the purpose of disinfecting or destroying pests or microorganisms. Hazard – a situation, condition, process, material or thing that may cause an injury or illness to a worker. Health and Medical Surveillance Program – a program designed to assist in the identification of employees exhibiting signs or symptoms of occupational illnesses or diseases in their early treatable stages. Medical assessments or examinations may be offered pre-assignment, mid-assignment, and post-assignment. Patterns and trends can also be identified among groups of workers who share common occupational exposures and risks. Health protection and exposure prevention strategies can be modified to improve workplace safety conditions. Incineration – a treatment technology using combustion (burning at high temperatures) to burn certain materials under controlled conditions to destroy hazardous waste and reduce the volume of waste. Infectious Dose – the dose or number of organisms required to initiate infection, dependent on route of infection. Irradiation – a process involving the use of low levels of radiation to reduce the presence of disease causing organisms. Laboratory-acquired Infection (LAI) – an infection that results from laboratory work, whether it occurs in a laboratory worker, or in another person who happened to be exposed, as a result of work with infectious agents. Material Safety Data Sheets (MSDSs) – technical bulletins which provide detailed hazard and precautionary information for controlled products. Microtome – a mechanical instrument used to cut biological specimens into very thin segments for microscopic examination.


http://en.wikipedia.org/wiki/Dehydration

http://en.wikipedia.org/wiki/Preserve

http://en.wikipedia.org/wiki/Freezing

http://en.wikipedia.org/wiki/Pressure

http://en.wikipedia.org/wiki/Sublimation_%28physics%29

http://cancerweb.ncl.ac.uk/cgi-bin/omd?application

http://cancerweb.ncl.ac.uk/cgi-bin/omd?smoke

http://cancerweb.ncl.ac.uk/cgi-bin/omd?vapor

http://cancerweb.ncl.ac.uk/cgi-bin/omd?gas

http://cancerweb.ncl.ac.uk/cgi-bin/omd?pests

http://cancerweb.ncl.ac.uk/cgi-bin/omd?microorganisms

Morbidity Rate - an incidence rate used to include all persons in the population under consideration who become clinically ill during the period of time stated. The population may be limited to a specific gender or age group, or to those with certain other characteristics. Mortality Rate (or Death Rate) – usually expressed as a percent or as deaths per 1,000 or deaths per 100,000. Parenteral Injection – the piercing of mucous membranes or the skin barrier through such events as needlesticks, human or animal bites, cuts, and abrasions. Pathogen – disease-causing organisms, prions and certain toxins that are capable of causing human or animal disease. Pathogenicity – an epidemiological term used to describe the ability of a particular disease agent of known virulence to produce disease in a range of hosts under a range of environmental conditions. Potentially Infectious Material (PIM) – materials potentially containing disease-causing organisms, prions or toxins, such as human and certain animal tissues, cell lines, and body fluids. Principal Investigator (PI) – the faculty member or supervisor who is responsible for workers in the laboratory space and/or workers conducting work under their supervision. Prion – a small proteinaceous infectious particle which resists inactivation by procedures that modify nucleic acids including irradiation, boiling, dry heat and chemical. Public Health Agency of Canada (PHAC) – a government agency which is focussed on more effective efforts to prevent chronic diseases, like cancer and heart disease, prevent injuries and respond to public health emergencies and infectious disease outbreaks. The PHAC has legislative authority over the handling, storage, and importation of biohazardous materials affecting humans only. Seronegative – not present in the blood (strictly, the serum), especially with respect to antigens, antibodies and a large range of molecules produced by the body. Sonication – the process of disrupting biologic materials by use of sound wave energy. Suitable Disinfectant – a decontaminant whose concentration and contact time has been shown to be effective for the specific biohazardous agents in question. Supervisor – the individual that directs or oversees a person, group, department, organization, or operation from the University of Calgary. Unfixed Specimens – cells that are not chemically treated for the purpose of immobilization, killing or preservation. Worker – any person engaged in work at the University of Calgary, including employees, contracted workers, volunteers, and graduate students. Workplace Hazardous Materials Information System (WHMIS) – a national hazard communication system which provides information on hazardous materials used in the workplace and to reduce the incidence of illness and injury caused by hazardous materials in the workplace.


http://www.biology-online.org/dictionary/Process

http://www.biology-online.org/dictionary/Biologic

http://www.biology-online.org/dictionary/Materials

http://www.biology-online.org/dictionary/Use

http://www.biology-online.org/dictionary/Sound

http://www.biology-online.org/dictionary/Wave

http://www.biology-online.org/dictionary/Energy

REFERENCES


Revision #: NEW Part: 12.1 References Revision Date: --


Agriculture and Agri-Food Canada’s Containment Standards for Veterinary Facilities, First Edition, 1996. Alberta Occupational Health and Safety Act, Regulations & Code http://employment.alberta.ca/cps/rde/xchg/hre/hs.xsl/307.html Baron, H., and Prusiner, S.B. “Biosafety of Prion Diseases” in Biological Safety: Principles and Practices, 4th Edition, Diane O. Fleming and Debra L. Hunt (Editors), ASM Press, 2006, pp 461-485. Baron, H., Safar, J., Groth, D., DeArmond, S.J., and Prusiner S.B. “Chapter 33: Prions” in Disinfection, Sterilization, and Preservation, 5th Edition. Seymour S. Block (editor) Lippincott Williams & Wilkins, 2001, pp.659-674. Collins, C.H. and Kennedy, D.A. Laboratory-Acquired Infections, History, Incidence, Causes and Preventions, 4th Edition, Butterworth Heinemann, 1999. Doblhoff-Dier, O. and Stacey, G. Cell Lines: “Applications and Biosafety” in Biological Safety: Principles and Practices, 4th Edition, Editors Diane O. Fleming and Debra L. Hunt, ASM Press, 2006, pp 221-240. Favero, M.S. and Arduino, M.J. “Decontamination and Disinfection” in Biological Safety: Principles and Practices, 4th Edition, Diane O. Fleming and Debra L. Hunt (Editors), ASM Press, 2006, pp 373-381. Public Health Agency of Canada’s Guidelines for biomedical facilities using sheeps as research animals (December 2000): http://www.phac-aspc.gc.ca/ols-bsl/animres_e.html Public Health Agency of Canada’s Laboratory Biosafety Guidelines, 3rd Edition, 2004. Schmid, I., Nicholson, J.K.A., Giorgi, J.V, Janossy, G., Kunkl, A., Lopez, P.A., Perfetto, S., Seamer, L.C., and Dean, P.N. (1997). “Biosafety Guidelines for Sorting of Unfixed Cells” in Cytometry, Wiley-Liss, Inc., 28:99-117.


University Policy University Procedure Instructions/Forms

Occupational Health and Safety Policy

Classification Health, Safety and Environment

Table of Contents

Purpose 1Scope 2Definitions 3Policy Statement 4Responsibilities 5History 6

Approval Authority Board of GovernorsImplementation Authority General Counsel/Corporate Secretary Effective Date December 08, 2005Latest Revision December 8, 2005

Purpose 1

The purpose of this policy is to ensure that all individuals understand their obligations under the Alberta Occupational Health and Safety Act, Regulations and Code and their responsibilities associated with ensuring a safe and healthy living and learning environment.

Scope 2

This policy applies to all individuals in the workplace - officers, directors, managers, supervisors, faculty, staff, contractors, volunteers, students and visitors. All share the responsibility for ensuring a safe working, learning and living environment.

Definitions 3

In this policy

a) “Approval authority” means the office responsible for approving this policy.

b) “Implementation authority” means the officer responsible for

implementing this policy as well as monitoring compliance. Vice President (Finance and Services) as a representative of the Senior Executive Group (SEG).

c) “Senior Executive Group” means the President, Vice Presidents, Chief

Development Officer, Advisor to the President on Student Affairs, Advisor to the President on Strategic Initiatives, General Counsel.

Policy 4 4.1 The University of Calgary considers health and safety to be a priority and is

Statement committed to providing a safe and healthy work and study environment for the entire University community. This will be possible by meeting or exceeding all regulatory requirements and ensuring that the University fully implements its Occupational Health and Safety Management System. The goal of the University of Calgary is to integrate health and safety into all aspects of University activities. To this end, specific responsibilities are designated for employees and students. This shared responsibility for occupational health and safety is the basis for the University’s internal Occupational Health and Safety Management System (OHSMS). 4.2 All faculty members, employees, students, volunteers, contractors and visitors are required to comply with all University health and safety policies, procedures and rules, as well as all applicable legislation. Nothing in this policy is to be interpreted as qualifying in any way the requirements under the Act and should there be, or perceived to be, any conflict between this Policy and the Act, the provisions of the Act shall take precedent.

Responsibilities 5

Full commitment from all staff and students is required to successfully implement this policy. All individuals in the workplace - officers, directors, managers, supervisors, faculty, staff, contractors, volunteers, students and visitors - share the responsibility for ensuring a safe working, learning and living environment. Specified responsibilities identified in the OHSMS document are considered obligatory unless otherwise specified. The Board of Governors is responsible for ensuring that this policy is approved, implemented, and reviewed and updated on a regular basis, and that there is appropriate delegation of persons responsible for implementing this policy. The Implementation Authority is responsible for allocating appropriate resources, facilitating the implementation of health and safety programs, supporting the development of occupational health and safety performance measures, enforcing all University rules, policies and procedures, monitoring performance, and regularly evaluating programs. Supervisors (including, but not limited to, Associate Vice Presidents, Directors, Deans, Heads, Managers, Principle Investigators, etc.) are accountable for the safety systems and obligations specified in the legislation within their area of jurisdiction and for compliance with all applicable health and safety legislation and University policies and rules, including ensuring that all those reporting to them receive appropriate training related to health and safety practices, procedures and precautions. Specific safety functions for supervisors will be identified in the University of Calgary’s Occupational Health and Safety Management System Outline of Responsibilities which is currently being drafted. Employees are responsible for taking all reasonable means to protect themselves and others from work related injury or illness. This means that they must follow all University safety guidelines, procedures and rules and report any unsafe or unhealthy conditions to their supervisors. Employees are required to be informed about health and safety rights and responsibilities and to be educated about workplace hazards and controls. Specific safety functions for employees will be identified in the University of Calgary’s Occupational Health and Safety Management System Outline of Responsibilities.

Printed April 30, 2008 The electronic version is the offical version of this policy .

Students, volunteers and visitors are required to fully co-operate to facilitate the University’s compliance with legislation and to make certain that the University environment is safe for everyone. All contractors and subcontractors are required to comply with applicable legislation and University safety rules. The Department of Environmental Health and Safety (EHS) will provide support and advisory services in health and safety to assist those with responsibilities under this policy. EHS will be responsible for identifying regulatory requirements, developing support and advisory services to assist supervisors in carrying out their responsibilities and reporting regularly to the Senior Executive on the University’s occupational health and safety status and performance.

History 6

There are no previous versions of this document available to be viewed.

Drafted : November 2005

Approved : December 8, 2005 (Board of Governors; Meeting #3, 2005-06; Agenda Item 7.1)

Effective : December 8, 2005

APPENDIX BBiohazard Laboratory Safety Audit

Questions

Date of Issue: 2008.01.07 Section: Appendix B Issued By: Environment, Health & Safety

Revision #: NEW Part: Biohazard Laboratory Safety Audit Questions Revision Date: --


General Requirements

1. Is the laboratory’s Biohazard Laboratory Posting complete, correct, up to date, and posted outside the doors of the laboratory (in accordance with Laboratory Biosafety Guidelines)? If you need a new posting contact the [email protected].

2. Have all persons in your laboratory attended the mandatory ”Introduction to Biosafety” module of the Biosafety Course? This module is mandatory for persons who started working with biohazardous materials at the University of Calgary after January 1, 1997.

3. Have all biohazardous materials that are being handled and stored, and all the areas where those materials are being handled and stored received approval from the University of Calgary Biosafety Committee? To receive approval, register your biohazardous materials by using the on-line biohazardous materials registration (as outlined in Section 3.1 of the Biosafety Manual).

4. Is a current copy of Health Canada’s "Laboratory Biosafety Guidelines”, and a laboratory safety manual, that identifies known and potential hazards, and specifies practices and procedures to eliminate or minimize such risks, available in the laboratory, and the presence, location and significance of those documents is known to laboratory staff?

5. Are all laboratory personnel trained by the Principal Investigator in appropriate safety precautions and procedures, and is the training documented?

6. Have emergency response plans for the handling of spills of infectious materials and for self-contamination/personal injury involving infectious materials been developed? Are those emergency response plans implemented, ready for use, known to all laboratory staff, and can those emergency response plans be carried out?

7. Do all personnel know, understand, and follow standard practises, appropriate safety precautions and procedures? Have all personnel demonstrated competence in safe technique before work with hazardous agents is allowed?

8. Is the laboratory kept neat, orderly, and clean, and is the storage of non-pertinent items minimized?

9. Is protective laboratory clothing available in the laboratory, and worn properly fastened by all personnel, including visitors, trainees, and others entering or working in the laboratory, and not worn into non-laboratory areas unless directly work-related?

10. Is the necessary Personal Protective Equipment (PPE) available in the laboratory and worn when necessary, and is personnel trained in the proper use of PPE?

11. Is a written policy available in the laboratory that prohibits eating, drinking, the storing of food, beverages, personal belongings, utensils, applying cosmetics, and the inserting or removal of

Appendix B - 1 of 3

contact lenses in the laboratory? Are those requirements clearly and visibly posted, and do staff adhere to them?

12. Is a written policy available in the laboratory that prohibits the recapping of needles and mouth pipetting in the laboratory? Are those requirements clearly and visibly posted, and do staff adhere to them?

13. Is a written policy available in the laboratory that mandates the restraining or tying back of long hair, and do staff adhere to it?

14. Is a written policy available in the laboratory that makes it mandatory to wash hands before leaving the laboratory, and at any time after handling materials known or suspected to be contaminated, even when gloves have been worn? Is the requirement clearly and visibly posted near the dedicated sink, and do staff adhere to them?

15. Is a written policy available in the laboratory that mandates work surfaces to be cleaned and decontaminated with a suitable disinfectant at the end of the day and after any spill of potentially dangerous material?

16. Is a written policy available in the laboratory that specifies that all technical procedures have to be performed in a manner that minimizes the creation of aerosols? Do staff adhere to them?

17. Is a written policy is available in the laboratory that specifies that all spills, accidents, and overt or potential exposures have to be reported in writing to the Principal Investigator as soon as circumstances permit, and for the Principal Investigator to file a report with the Biosafety Officer. As part of this policy guidance regarding the appropriate medical evaluation, surveillance and treatment should be sought and provided as required. The policy shall further specify that the actions taken prevent future occurrences shall be documented and become a part of the report to the Biosafety Officer? Do staff adhere to them?

18. Are laboratory workers protected by immunization, where possible, or show immunity to relevant infection?

19. Are personnel adequately trained and competent in the disposal of biohazardous and biomedical wastes as evidenced by appropriate wastes found in waste containers?

Containment Level 2 20. Are laboratory doors closed and remain closed while manipulations with biohazardous materials

are performed?

21. Are handwashing facilities, soap, and towels provided and accessible?

22. Are laboratory furnishings impervious and readily cleanable?

23. Are separate hanging areas provided for street and laboratory clothes, and are coat hooks for laboratory coats installed near the exit?

24. Is an autoclave available in or near the laboratory? Are biohazardous wastes transported to the autoclave in a manner that minimizes the potential for a spill?

25. Are Class I or II Biological Safety Cabinets (BSC) available and used for all manipulations involving the biohazardous agent(s) which may create an aerosol?

26. Has the Biological Safety Cabinet been tested within the last 12 months?

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27. Is centrifugation carried out using closed containers or safety heads or sealed cups, and those closed containers or safety heads or sealed cups are opened only inside of a Biological Safety Cabinet?

28. Are infected animals or insects housed in the laboratory or an appropriate animal containment facility?

29. Is a written policy and procedure available in the laboratory that limits access to the laboratory to authorized individuals? Does the P&P manual mandate that those individuals have to be advised of the potential hazards, that those individuals may have to meet some specific entry requirements (immunization, not immuno-compromised, etc.), and that such authorized persons have to be provided the same kind of protection from hazards as persons working in the laboratory?

30. Are vacuum lines that are used for work involving biohazardous agent protected from contamination by HEPA filters or equivalent equipment?

31. Is a written policy available in the laboratory that prohibits the wearing of laboratory coats and other Personal Protective Equipment outside the containment laboratory unless on direct and immediate laboratory business, and is the requirement posted and clearly visible in the laboratory?

32. Is a written policy available that makes the wearing of gloves mandatory when the skin may be exposed to infectious materials or when infected animals are handled, and is the requirement posted and clearly visible in the laboratory?

33. Is a written policy available in the laboratory that mandates that all potentially contaminated materials and equipment are decontaminated before leaving the laboratory with procedures that have been demonstrated to be effective?

Containment Level 3 Laboratories Only 34. Is the laboratory at negative pressure at all times, and is there a control system to ensure that

the laboratory is never positively pressurized relative to surrounding areas?

35. Is the laboratory air exhausted through a HEPA filter system, or through a sealed, dedicated exhaust system that discharges the air directly to the outside?

36. Is the HEPA filtration system designed to allow in situ decontamination and testing?

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biosafety and procedures manual · 2.3.5 trained laboratory worker 2.3.6 absence of a principal...

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