St. Michael’s Hospital Biosafety Program is designed to safeguard laboratory personnel and the public from potential exposure to biological materials. The Biosafety Manual is a comprehensive guide to ensure a safe, secure, and compliant research environment for handling, transporting, and disposing of hazardous biological agents. The manual provides flexible guidelines, enabling researchers and principal investigators to adapt sections to their specific experimental needs.
KRCBS Containment Level 2 (CL2) facility adheres to Canadian biosafety standards for handling moderate-risk biological agents. It employs multiple security layers to prevent pathogen release, including key card access, sealed windows, and biohazard signs. The facility has biosafety cabinets, chemical fume hoods, and other engineering controls for added protection. Stringent waste disposal, decontamination, and personnel training protocols ensure compliance.
Per the Canadian Biosafety Standard, Third Ed. regulated material risk assessments hinge on science, policy, and expert judgment. St. Michael’s Hospital requires all labs working with biological agents to have an approved Research Biosafety Permit specifying the Risk Group of the biological agents being actively used or in storage. The Biosafety Officer assesses and reviews the biosafety permits. The risk assessment covers biological, chemical, and procedural hazards. Principal investigators might be asked to submit an SOP with the biosafety permit for approval. Occupational health and safety specialists and subject matter experts contribute to biological and chemical agent risk assessments. To mitigate risks, personnel need proper training, technical proficiency, adherence to good lab practices, and maintenance of containment equipment and facility safeguards.
Biosecurity includes security measures to prevent the loss, theft, misuse, diversion, or intentional release of biological agents. The research personnel must adhere to regulatory requirements outlined in the Human Pathogens and Toxins Regulations, incorporating physical measures and operational procedures. These measures include conducting:
Adherence to established biosecurity procedures is mandatory for research personnel, with Principal Investigators (PIs) ensuring compliance within their respective laboratories.
A breach of biosafety and biosecurity could potentially occur during emergencies, accidents, or incidents. Therefore, it is crucial to have well-defined response plans and reporting procedures in place. Clear communication of these plans to all staff is essential to ensure that appropriate actions are taken promptly in the event of any such situation. An annual refresher in Emergency Response Procedure is mandatory for all staff members. This proactive approach is vital for minimizing risks and maintaining the safety and integrity of the biosafety and biosecurity measures in place.
The comprehensive program includes promoting awareness of disease symptoms, administering immunizations and other prophylaxis, conducting medical pre-placement activities such as interviews and examinations, obtaining clearance, establishing post-exposure procedures, and providing emergency medical assistance. The health and safety specialists also assist the BSO.
Associated policies:
Research personnel are encouraged to report all incidents, because it provides the opportunity for post-exposure treatment (if available) as well as the opportunity for parties involved to analyze the causes of the incident, identify weaknesses in current procedures and correct hazardous situations in the workplace if present.
All incidents must be reported to the employer by using the online incident reporting tool – ‘Safety first’. Within this tool, there exists a designated section titled “Employee Affiliate,” where personnel can report various occurrences including health and safety incidents, workplace hazards, instances of harassment or discrimination, and incidents of professional misconduct.
In cases where an incident involves exposure to or release of a human pathogen or toxin, it is imperative to report the incident to regulatory authorities. The Biosafety Officer (BSO) is responsible for reporting such incidents to the Public Health Agency of Canada (PHAC) via the biosecurity portal. However, researchers also have the option to directly report exposure or release incidents to PHAC by contacting them at biosafety.biosecurite@phac-aspc.gc.ca.
Associated links:
Training is a mandatory requirement outlined in the Federal Human Pathogens and Toxins Regulations (HPTR) and the provincial Occupational Health and Safety Act (OHSA) of Ontario. The responsibility for ensuring compliance with this requirement rests with the principal investigator (PI), supervisor, or manager. They are tasked with ensuring that all personnel complete both the mandatory training and any additional training specific to the nature of the work being conducted.
Biosafety training for New Hires – Workers are required to attend a half-day biosafety training course within the first three months of starting work. This includes WHMIS regulations, risk group classification, risk assessments and the requirements for containment level 1 and 2 labs, basic laboratory biosafety, emergency response procedures, and infection control practices. All personnel are required to take the annual refresher safety trainings, these include Biosafety, Chemical Safety, Laboratory Safety, Emergency Response Procedures and Fire Safety
Documentation of an individual’s participation and successful completion of training, may take various forms such as attendance sheets, orientation checklists, examinations, certificates, or other relevant records. Essential details, including the individual’s name, date of completion, and specifics of the training course, should be included in these records. Individuals/labs are expected to retain copies of their training records. Principal investigators, supervisors, or managers should keep copies of training records for all personnel, including both Unity Health and laboratory-specific training, in a central location.
Wet-bench safety trainings will soon migrate to Unity Health’s online learning platform Learning Centre. The system will send automated reminders for annual refreshers and store all trainings on the personnel dashboard. This migration will be complete by the end of 2024 and will eliminate the requirement for printed training certificate binders currently maintained by the labs.
Aligned with the standards, we conduct annual assessments of our existing training, carefully evaluating them against established objectives.
This systematic review is instrumental in identifying any gaps or deficiencies, allowing us to implement strategies for continuous improvement.
Laboratory research animals play a significant role in studies involving hazardous biological agents, necessitating a thorough understanding of biosafety requirements in such contexts. Pertinent regulations governing animal research at St. Michael’s Hospital include those set forth by the Canadian Council on Animal Care (CCAC), the Canadian Food Inspection Agency (CFIA), the Public Health Agency of Canada (PHAC), the Canadian Biosafety Standard (CBS), 3rd Edition, and the Canadian Biosafety Handbook (CBH, Chap 13), 2nd Edition, in addition to Unity Health procedures.
Meticulous waste management practices are crucial for the proper disposal of biological materials and other potentially hazardous substances.
At Keenan Research Centre Biomedical Sciences, our dedication to safety includes thorough housekeeping overseen by a trusted vendor. Specially trained custodial staff maintains cleanliness and safety daily, including dust mopping lab areas and managing biohazard waste. Every evening, they collect and dispose of biohazard waste and ensure sharps safety with strategically placed containers. The housekeeping team promptly replaces full sharps containers, and responds to slip/fall situations, contributing to overall safety. They also ensure handwashing supplies are always available in the laboratories. The staff undergoes safety training within their organization; they collaborate closely with the biosafety officer and environmental services. Monthly meetings of the supervisory team provide a forum to discuss crucial issues, and housekeeping supervisors conduct regular walk-throughs to maintain a vigilant stance on safety practices.
The Engineering & Plant Services oversees facility maintenance, ensuring the overall infrastructure’s functionality.
Research Facilities manages core equipment, and lab personnel handle maintenance of equipment owned by their labs.
Adherence to Standard Operating Procedures (SOPs) is fundamental under the Canadian regulatory framework. Accessible through the research facilities website’s Standard Operating Procedures tab, commonly used procedures are readily available, promoting a standardized approach to biosafety practices.
The hospital has an internal licensing system that controls the radioisotope types and amounts, their uses within areas in the hospital. Every wet bench researcher that uses a radioisotope must hold a radioisotope use permit. Information on handling, transport, and safe use procedures for radioactive substances can be found here. The documents contained here cover procedures for wet bench researchers, but also for applications within the hospital. For further information on radiation safety and the use of radioisotopes, contact the Radiation Safety Officer.
