OVERCOMING THE CHALLENGES FACED IN IMPLEMENTING THE ...
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OVERCOMING THE CHALLENGES FACED IN IMPLEMENTING THE REQUIREMENTS OF THE CBS, HPTA AND HPTR
Ingrid Abbott-Permell RBP, CBSP, SM(NRCM)
2019 Canadian Biosafety Symposium
September 19, 2019
Universal Biosafety Inc.
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Introduction – HPTA & CBSGu HPTA 2009
u Facility Registration
u Assignment of a BSO
u Reasonable precautions to protect the health and safety of the public
u Prohibition of activities with agents listed in Schedule 5
u Canadian Biosafety Standards and Guidelines 1st Edition, 2013
u Harmonization of the following documents:
u Laboratory Biosafety Guidelines (LBG) 3rd Edition
u Containment Standards for Veterinary Facilities 1st Edition.
u Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms handling Prion Disease Agents 1st Edition.
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Introduction – HPTR & CBS
u HPTR 2015
u Enforced all other aspects of the HPTA
u Licence with conditions for conducting controlled activities
u Canadian Biosafety Standards 2nd Edition, 2015
u National Standard governing manipulation of human and terrestrial animal pathogens and toxins.
u Mandatory physical, operational and performance verification requirements for CL2, CL3, CL4 containment zones
u Laboratories, Large scale facilities, Animal zones, SSBA, Prions
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Biosafety Compliance Historyu Facilities made an easier transition to HPTR and the CBS
u LBG and CBSG guided the development and/or enhancement of biosafety programs
u Internal inspections against the requirements of the CBSG
u Development of plans for closing gaps identified in inspections
u Facilities not utilizing the LBG and CBSG in preparation for regulatory changes may experience a more difficult transition.
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Biosafety Culture
u Culture
u Values, beliefs, behaviours, practices that support safe science/biosafety irrespective of standards, codes, regulations
u Facilities having a strong biosafety culture
u Greater alignment with good microbiological practices and
u Smoother transition to the regulatory requirements
u Facilities with a weak or non-existent culture may face greater challenges
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We’ve been doing it this way for years……and nothing happened!
u Unaware of hazards associated with controlled activities
u Lack or awareness of risks associated with pathogens, toxins and specific activities
u Lack of awareness of potential exposures and/or infection
u Unaware that the HPTA, HPTR, CBS requirements are mandatory
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Resistance to change u Changing old habits, procedures, culture
u Additional resources e.g. financial or additional personnel
u …we’ve been doing it this way for years
u Hinders the obligation to protect the health and safety of the public and indeed protection of staff
u Hinders compliance
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The HPTR Licence
u Conducting controlled activities without a Licence
u Staff unaware of the existence of the Licence and the associated conditions
u Requirements for movements, lost or missing pathogens and toxins.
u CFIA requirements for animal products, foreign and emerging animal diseases etc.
u Decontamination and record keeping requirements
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The BSO & The Licence Holderu Both mandatory under the HPTA and HPTR with specific roles and responsibilities
u The BSO is the Licence Holder
u BSO meets the qualifications as per HPTA & HPTR
u Fewer challenges
u The Licence Holder is also the BSO
u Licence holder has other responsibilities
u Limited biosafety knowledge or experience
u May experience greater challenges
u BSO operates outside of Canada / Corporate BSO
u Corporate requirements vs Canadian Biosafety requirements
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The Biosafety Programu There is no structured biosafety program in place
u Some elements may exist
u Lacking or limited key program elements
u Biosafety program does not align with the facility’s program intent or activities
u Large scale activities – program does not include large scale safety
u Animal containment zones – no safe animal-handling techniques included
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Biosafety vs Qualityu Is there a conflict?
u Can we find synergies?
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Biosafety & Quality Key Elementsu Physical requirements
u Access control systems
u Structure, location, containment perimeter, surfaces etc
u Equipment maintenance
u Decontamination technologies e.g. autoclaves, decon in place in equipment
u Operational requirementsu Program management
u Medical surveillance
u Training
u Entry / exit procedures
u PPE-Product or personnel protective equipment
u Records and documentation
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Biosafety & Quality Key Elements
u Equipment and Facility Performance and Verification Testing
u Air handling systems
u Equipment maintenance, HEPA filter testing
u Some are in alignment and some may be in conflict
u Finding the balance or solutions to achieve objectives.
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Risk Assessmentu Inability to conduct a biological risk assessment
u Performed by one person
u Incomplete assessment
u Assessing only the agent and not the activities, environment or equipment used for conducting controlled activities.
u The risk is not identified or described or controls do not match the risk
u e.g. risk of exposure via injection – with no sharps precautions
u The risks and mitigation strategies are not communicated nor implemented.
u The risk assessment is documented and filed – no action taken
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Toxinsu Included in the HPTA and HPTR
u Schedule 1 of the HPTA
u SSBA include toxins above trigger quantities
u “Live vs Non-live”
u Live organism is infectious – hazardous
u Misconception: Non-live toxin is non-hazardous because it is non-infectious
u Toxins are not included in the Local Risk Assessment
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Equipment Hazardsu Laminar flow hoods, fume hoods, biosafety cabinets
u Not knowing the difference, how they operate or protection provided
u Using the wrong device
u Improper use of biosafety cabinets
u Overcrowded, blocked grilles, two people working at one cabinet
u Autoclaves
u Validation vs Verification – what do they mean?
u Loss of containment from equipment
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Trainingu Limited or ineffective biosafety training
u Training needs assessment not completed
u Basic principles or biosafety or good microbiological practices not included or not understood
u Biosafety cabinets in use without training on proper use
u Safe animal handling techniques not included for animal zones.
u No training on accident reporting and investigation
u What is a PSDS?
u Training not relevant to the type of containment zone
u Laboratory, large scale, SA or LA zone etc.
u Read and review vs performance based
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Overcoming the Challengesu Understand the HPTA, HPTR & Licence requirements
u Understand how to use the CBS
u Country requirements takes precedence over external requirements
u Communicate the Licence and conditions to staff
u Do a status check and change the culture
u Build the program starting with key elements
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Overcoming the Challengesu Revisit the biological risk assessment
u PHAC Guideline on Local Risk Assessment
u Include an assessment of equipment and associated hazards
u Involve the team and share the assessment
u Build institutional biosafety capacity
u Find the synergies between Biosafety and Quality
u Toxins are hazardous material and some are regulated
u Training, training, trainingu Make it performance based and verify competence
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Thank you for your attention
Questions????
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