BIOSAFETYTRAINING Tina Preseau* & Rita Toussaint-Archambault *Office of Risk Management Human Resources - Occupational Health Disability & Leave
COURSE OUTLINE • Introduction • Laboratory Associated Infections • Blood-borne Pathogens • Classification of Biohazards • Infection/Biohazard Control • Spill Response • Biomedical Waste • Regulations BIOSAFETY
WHAT IS A BIOHAZARD? • A potential hazard to humans, animals or the environment caused by a biological organism, or by material produced by such an organism • Examples: • Viruses, bacteria, fungi, and parasites and their product. • Blood and body fluids, as well as tissues from humans and animals. • Transformed cell lines and certain types of nucleic acids .
WHAT IS BIOSAFETY? • Measures employed when handling biohazardous materials to avoid infecting oneself, others or the environment. • Achieved through; • Administrative Controls • Engineering Controls • Personal Protective Equipment • Practices and Procedures
WHAT IS BIOSECURITY? • Measures employed to protect biohazardous materials, or critical relevant information, against theft or diversion by those who intend to pursue intentional misuse. • Achieved through; • Physical barriers • Psychological barriers • Monitoring Activities • Personnel Clearance
WHO ARE THE STAKEHOLDERS? EXTERNALLY • Public Health Agency of Canada • Canadian Food Inspection Agency • Environment Canada • Transport Canada • Ontario Ministry of Labour • Emergency Response Personnel • Suppliers & Contractors • Community INTERNALLY • Vice-President (Research) • Committees • University Services (ORM, HR, PRS, PS) • Deans, Chairs, Principal Investigators, Employees, Students • Manager of Biological Containment Suite ACCOUNTABILITY
KEY SERVICES • Office of Risk Management • Training • Interface with Regulatory Bodies • Biosafety Program certifications training procedures inspections contingency planning accident/incident follow-up
KEY SERVICES • HR (Occupational Health, Disability and Leave) • Medical surveillance • Immunizations • Medical Follow-up • Interface with Workplace Safety and Insurance Board
WHY ARE WE CONCERNED? • Potential for acquiring a laboratory-associated infection (LAI) • Contamination of the environment • Contamination of research • Public perception
LABORATORY ASSOCIATED INFECTIONS • Percutaneous inoculation • Inhalation of aerosols • Contact of mucous membranes • Ingestion Infection Source • Cultures and stocks • Research animals • Specimens • Items contaminated with above Susceptible Host Route of Transmission • Immune system • Vaccination status • Age
LAIS • Only 20% causative or defined event • 80% of which are caused by human factors • 20% are caused by equipment failure • Top 4 accidents resulting in infection • Spillages & splashes • Needle and syringe • Sharp object, broken glass • Bite or scratch from animals or ectoparasites http://www.weizmann.ac.il/safety/bio2.html
BLOODBORNE PATHOGENS (BBP) • Sources • Blood • Semen • Vaginal Secretions • Other Bodily Fluids Cerebrospinal Amniotic Synovial • Tissue Cultures • Organ Cultures • Infected Experimental Animals
RISK OF EXPOSURE • Pathogen involved • Type of body fluid • Route of exposure • Duration of exposure • Volume of blood involved in exposure • Concentration of virus at time of exposure • PPE worn
SPECIFIC EXAMPLES OF BBPS Hepatitis B Hepatitis C HIV
ISSUES TO CONSIDER • Symptoms • Mode of transmission • Incubation period • Survival outside host • Communicability • Immunization • Prophylaxis / Treatment
IF AN EXPOSURE OCCURS • Initiate first aid • Notify your supervisor / designated person • Report to hospital emergency department or University’s Health Services • Report incident to OHDL Occupational Health, Disability and Leave Office telephone ext. 1472 http://www.rh.uottawa.ca/00_main/index_f.asp
UNIVERSAL PRECAUTIONS • Minimum standard of practice for preventing the transmission of BBP includes: • Education • Hand washing • Wearing protective barriers • Use safe work practices If samples cannot be guaranteed non-infective …… treat as infectious!
BIOHAZARD CLASSIFICATION • Conventional Agents • Recombinant DNA • Tissue Culture • Animal Work • Anatomical Specimens • Unconventional Agents Class D, division 3 of WHMIS (Poisonous and Infectious Material - Biohazardous Infectious Material)
BIOHAZARD CLASSIFICATION • Organisms are categorized into a group base on the particular characteristics of each organism, such as • Pathogenicity • Infectious dose • Mode of transmission • Host Range • Availability of effective preventive measures • Availability of effective treatment
BIOHAZARD CLASSIFICATION • Organisms are categorized base on the measuresrequired for handling each organism safely in a laboratory setting, such as • Engineering Requirements • Operational Requirements • Technical Requirements • Physical Requirements
CONVENTIONAL AGENTS Unlikely to cause disease in healthy workers or animals Rarely cause serious human or animal disease May cause serious disease Likely to cause very serious disease
RECOMBINANT DNA • Genetic Engineering = in vitro incorporation of genetic material from one cell into another • In Canada the level of risk depends on source of DNA, vector and host. • The Office of Risk Management will assist the investigator in this determination.
TISSUE CULTURE • Have the potential to contain pathogenic organisms • In general; Human & non-human primate, and mycoplasma-containing cell lines Level 2 Others Level 1 A detailed risk assessment should be undertaken when using a new cell line.
ANIMAL WORK • Animals can harbour infectious organisms (naturally or introduced) • Level dependent on type of work being conducted. • Special Animal Care training is required for all personnel working with animals. • All work involving animal use must receive prior approval from the Animal Care Committee
ANATOMICAL SPECIMENS • All specimens should be considered infectious due to potential presence of infectious agents • Important to consider the type of specimen • blood, organs, tissues • Spinal sample, brain tissue • From infectious patient • In general Level 2 but it depends on the nature of the work.
UNCONVENTIONAL PATHOGENS • TSE prion diseases; lethal transmissible neurodegenerative conditions • Creutzfeld-Jakob disease, Variant C-J Disease, Mad Cow Disease, Scrapie, Chronic Wasting Disease • Resistant to destruction by procedures that normally inactivate viruses. • Contact ORM to assess requirements (containment, procedures, waste disposal, etc.)
INFECTION/BIOHAZARD CONTROL • Administrative Controls • Engineering Controls • Personal Protective Equipment • Practices and Procedures
ADMINISTRATIVE CONTROLS • Program based, information and methods to minimize risk of exposure: • Risk assessment • Medical Surveillance • Training/Education • Resources • Inspections • Signs & Labeling
ADMINISTRATIVE CONTROLS Risk Assessment • Will determine type of containment, procedures, and safety equipment required • Responsibility of users, additional assistance is available from the ORM • Consider areas such as; experimental design, procedures to be employed and personal experience/knowledge, etc. • Know and understand the various characteristics of the agent(s) you are working with. (Material Safety Data Sheets and suppliers or manufacturers)
ADMINISTRATIVE CONTROLS Medical Surveillance Training & Education • WHMIS • Lab specific policies and procedures • Biosafety training Resources • ORM web site, Biosafety page • Faculty web sites • Biosafety Manual • Training Videos
ADMINISTRATIVE CONTROLS Inspections • Routine self-inspections • Biosafety Inspection Checklist available on-line • In addition, ORM, EHSOs and OH&S will inspect labs to ensure compliance with regulations/ guidelines and provide feedback.
ADMINISTRATIVE CONTROLS Signs & Labeling • Biohazard warning signs must be posted on doors to rooms where biohazardous materials are used. • Biohazard labels should be placed on containers, equipment and storage units used with biological agents.
ENGINEERING CONTROLS • Technology based, reduce or eliminate exposure to hazards by changes at the source of the hazard. • Containment: • Types: Primary and Secondary • Containment levels
PRIMARY CONTAINMENT • First line of defence. • Ensures protection of personnel and immediate environment from exposure to the infectious agent. • ‘Protective envelope’ that encapsulates the infectious agent or animal. • Petrie dish, vial, stoppered bottle…. • Biological safety cabinets, glove boxes and animal caging equipment, etc. Effectiveness of control is based on the integrity of the containment.
SECONDARY CONTAINMENT • Protects the environment external to the laboratory from exposure • Includes facility design and operational practices
CONTAINMENT LEVEL 1 • Basic laboratory • Requires no special design features • Biosafety cabinets are not required and work may be performed on the open bench.
CONTAINMENT LEVEL 2 • Clinical, diagnostic, research and teaching facilities with level 2 agents. • Requires a class I or class II biological safety cabinet if any potential for aerosol or splash exists. • An emergency plan for handling spills must be developed. • Access should be controlled.
CONTAINMENT LEVEL 3 • Specialized design and construction • primary barriers to protect the individual • secondary barriers to protect the environment • All staff must undergo special training on the agents being used, PPE, equipment, waste management as well as practices and procedures above and beyond the scope of this course.
CONTAINMENT LEVEL 4 • Only one level 4 facility in Canada (Canadian Centre for Human and Animal Health in Winnipeg, Man.) • Design specifications are extremely stringent, worker is completely isolated from infectious material.
BIOLOGICAL SAFETY CABINETS • Effective means of primary physical containment for biological agents, especially when aerosols are generated. • HEPA filters remove particles (min 0.3 microns) with 99.97% efficiency. • There are 3 main classes of cabinets (I, II, III) which provide various levels of protection.
BIOLOGICAL SAFETY CABINETS • Biological Safety Cabinet • HEPA filtered laminar air flow • Exhaust • Personnel, environment & product protection • Laminar flow hoods • Vertical or horizontal laminar flow • HEPA filtered air (intake only) • Product protection only VS
WORKING SAFELY IN A BSC Before using the cabinet: • Ensure BSC is certified • Turn off UV lamp; turn on fluorescent lamp • Disinfect work surfaces with appropriate disinfectant • Place essential items inside cabinet • Allow the blower to run for 5-10 min before work
WORKING SAFELY IN A BSC While using the cabinet: • Ensure material and equipment is placed near the back of the hood, especially aerosol-generating equipment. Do not block any vents • Use techniques that reduce splatter and aerosols. • General work flow should be from clean to contaminated areas • Minimize movement so as not to impede air flow • Open flame in BSC’s is controversial