The organization’s top management shall develop, authorize, and sign a policy concerning the management of laboratory biorisk (laboratory biosafety and laboratory biosecurity). It shall clearly state the overall biorisk management objectives and a commitment to improving biorisk management performance.
The policy shall be appropriate to the nature and scale of the risk associated with the facility and associated activities and commit to:
a) protecting staff, contractors, visitors, community and environment from biological agents and toxins that are stored or handled within the facility;
b) reducing the risk of unintentional release of, or exposure to biological agents and toxins;
c) reducing the risk to an acceptable level of unauthorized intentional release of hazardous biological materials, including the need to conduct risk assessments and implement the required control measures;
d) complying with all legal requirements applicable to the biological agents and toxins that will be handled or possessed, and with the requirements of this standard;
e) ensuring that the need for effective biorisk management shall take precedence over all non “health and safety” operational requirements;
f) effectively informing all employees and relevant third parties and communicating individual obligations with regard to biorisk to those groups;
g) continually improving biorisk management performance.
The organization shall ensure that a risk assessment system is established, implemented and maintained in accordance with this standard and that the performance of the risk management system is reported to senior management for review and as a basis for improvement.
The organization shall identify resource requirements and provide adequate resources, including the assignment of trained personnel for management, performance of work, and verification activities, including internal review.
The organization shall ensure the approach to risk assessment is defined with respect to its scope, nature and timing so that it is proactive rather than reactive.
The hazards associated with proposed work shall be identified and documented.
The organization shall ensure that suitable methodologies for assessing and recording risks are identified, implemented and maintained.
The organization shall ensure suitable methodologies for the allocation of actions resulting from risk assessments, including time lines, responsible persons and associated reporting and approval mechanisms are identified, implemented and maintained.
The organization shall ensure that all relevant requirements are identified and fulfilled within the biorisk management system. Legal requirements include national / federal, regional / state, provincial, city and local regulatory requirements with which the organization has to comply.
The organization shall establish, implement and maintain documented biorisk control objectives and targets for an effective control of biorisk at relevant functions and levels in the organization.
Management shall establish the controls and put in place documented procedures for monitoring the effectiveness of the controls being applied to reduce or eliminate the hazards identified in the risk assessment process.
Top management shall take ultimate responsibility for the organization’s biorisk management system.
Top management shall ensure that roles, responsibilities and authorities related to biorisk management are defined, documented and communicated to those who manage, perform and verify work associated with the control of biological agents and toxins.
Top management shall demonstrate its commitment by ensuring the availability of resources to establish, implement, maintain and improve the biorisk management system.
A senior manager shall be designated with operational responsibility for overseeing the system for
management of biorisk.
Functions of the system for the management of biorisk shall include:
a) providing appropriate resources to ensure adequate provision of personnel, facilities and other resources deemed necessary for the safe and secure operation of the facility;
b) reporting to top management on the performance of the biorisk management system and any need for improvement;
c) ensuring promotion of the biorisk management system throughout the organization;
d) instituting review, audit and reporting measures to provide assurance that the requirements of this standard are being implemented and maintained effectively.
A biorisk management committee shall be constituted to act as an independent review group for biorisk issues. Reporting to senior management, the committee shall:
a) have documented terms of reference;
b) include a representative cross-section of expertise, appropriate to the nature and scale of the activities undertaken;
c) ensure issues addressed are formally recorded, actions allocated, tracked and closed out effectively;
d) be chaired by a senior individual;
e) meet at a defined and appropriate frequency, and when otherwise required.
A competent individual(s) shall be designated to provide advice and guidance on biorisk management issues. This individual shall report directly to the responsible senior manager and have delegated authority to stop work in the event that it is considered necessary to do so. This role shall be independent of those responsible for implementing the programme of work.
An individual(s) with responsibility for the scientific programme within the facility shall be designated with responsibilities relevant to biorisk management.
Functions shall include:
a) ensuring that all work is conducted in accordance with established policies and guidelines described in this standard;
b) supervising workers, including ensuring only competent and authorized personnel can enter and work in the facility;
c) planning and conducting work activities, and ensuring adequate staffing levels, time, space and equipment are available;
d) ensuring required authorizations for work are in place;
e) ensuring laboratory biosafety and laboratory biosecurity risk assessments have been performed, reviewed and approved, and that the required control measures are in place;
f) ensuring that all at-risk employees have been informed of risk assessments and/or provisions for any recommended precautionary medical practices (e.g. vaccinations or serum collections).
The organization shall have access to appropriate occupational health expertise and establish an occupational health programme commensurate with the activities and risks of the facility.
Facilities manager(s) shall be appointed with responsibilities relevant to facilities and equipment determined in accordance with requirements set out in this standard.
A security manager shall be designated with responsibilities determined in accordance with requirements set out in this standard.
In laboratories where animals are maintained, an animal care manager shall be designated with responsibilities determined in accordance with requirements set out in this standard.
The organization shall ensure that qualifications, experience and aptitudes relating to biorisk are considered as part of the recruitment process.
The organization shall ensure that personnel conduct activities within the facility under close supervision until competency has been demonstrated.
The organization shall ensure that adequate back-up and contingency measures are in place to address the need for continuity and succession planning.
The organization shall ensure that requirements and procedures for biorisk-related training of personnel are identified, established and maintained.
The organization shall ensure that relevant biorisk information relating to its activities is communicated to and from employees and other relevant parties.
Employee involvement and consultation arrangements shall be documented.
Personnel shall have access to adequate and up-to-date information pertaining to the biorisks of the organization.
Employee involvement and consultation arrangements shall be documented.
Personnel shall have access to adequate and up-to-date information pertaining to the biorisks of the organization.
The organization shall ensure that a formal process is in place to identify and manage risk associated with general safety.
The organization shall ensure that an accurate and up-to-date biological agents and toxin inventory is established and maintained.
It shall ensure that records relating to the inventory of biological agents and toxins are current, complete and stored securely with adequate backup provision.
It shall ensure that transfers of biological agents and toxins between laboratories at the facility or into and out of the facility are recorded and controlled in line with the level of the risk.
The organization shall ensure that the programme of work for the facility is defined, documented and reviewed.
The organization shall establish criteria for work that requires prior approval.
It shall ensure there is sufficient resource capacity and capability to manage workflow, whether planned or unplanned.
The organization shall ensure that all changes associated with the design, operation and maintenance of the facility are subject to a defined and documented change management process.
The organization shall ensure that all personnel handling biological agents and toxins are competent in good microbiological techniques and that appropriate resources (including time and equipment) are available to ensure such practices can be adhered to effectively.
The organization shall establish and maintain procedures to ensure that appropriate methods for disinfectionand decontamination are chosen and implemented effectively.
The organization shall ensure that all contaminated or potentially contaminated waste items have been identified and documented (including those that may result from an emergency), and that effective procedures are put in place to devise effective decontamination and other appropriate treatments.
The organization shall establish and maintain an appropriate waste management policy for biological agents and toxins.
The organization shall ensure that PPE needs are identified and suitable equipment is specified, made available, used and maintained appropriately within the facility.
The organization shall ensure that risk to worker health, and that of other personnel whose health could be directly impacted by exposure to biological agents and toxins, is managed effectively including prevention and protection measures.
The requirements of the health surveillance programme shall be determined by a defined health hazard identification and risk assessment process involving all relevant personnel.
Based on risk, the need for vaccination shall be identified and shall cover groups identified as being potentially exposed to biological agents or toxins.
The organization shall ensure that a vaccination policy be defined and implemented, and that access to laboratories or work is controlled for individuals until they comply with the policy.
The organization shall ensure that a personnel reliability policy is defined and implemented and that access to facilities or work is controlled for individuals according to the policy.
The organization shall ensure that suppliers, contractors, visitors and sub-contractors adhere to the requirements of established management systems and do not compromise biorisk management of the facility.
The organization shall ensure that measures are set in place for the removal and exclusion of personnel (both temporary and, if appropriate, permanent) from the facility where deemed necessary through risk assessment.
The organization shall ensure that a formal planning, design and redesign process is adopted for the facility, based upon an assessment of risk associated with the materials to be used and activities undertaken.
The design process shall identify and incorporate all relevant legislative requirements, together with information from recognized standards, guidelines, industry good practices and facility-specific risk assessments.
The design process shall identify and consult all relevant parties associated with the facility and its operation.
All design features, construction techniques, materials and equipment selected shall be documented in line with the need to provide sufficiently specific and detailed instruction and information on the design specification.
The organization shall ensure that a new construction and physical facility modifications are carried out according to an approved plan.
The organization shall ensure that there is a formal process for initial commissioning of new facilities and the final decommissioning of existing ones.
The organization shall establish and maintain documented procedures to ensure equipment and elements of the physical plant that may impact on biorisk be identified, purchased, maintained, calibrated, certified or validated in a manner consistent with the intent and requirements of the biorisk management programme.
The organization shall ensure that the controls for the physical security of cultures, specimens, samples and potentially contaminated materials or waste determined as part of the risk assessment process are implemented and maintained.
The organization shall have a policy and procedure in place to identify sensitive information; a review and approval process shall be used to control access to such information.
The organization shall ensure that purchases (including services) conform to specified requirements. Controls shall be applied depending on potential impact on the biorisk involved.
The organization shall ensure suppliers are evaluated and selected based on their ability to provide products / services that meet the requirements of this standard. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
The organization shall ensure that procedures for the safe and secure transport of cultures, specimens, samples and contaminated and potentially contaminated materials are established and maintained in accordance with legal requirements for the transport of dangerous goods.
The organization shall have a policy in place to provide personal security support services to staff members that include, where appropriate, personal security awareness training.
The organization shall ensure that all credible and foreseeable emergency scenarios that may impact the organization’s biorisks have been identified.
The organization shall ensure that biorisks are taken into account when preparing and implementing emergency plans.
The organization shall ensure a system is established to effectively manage medical and/or environmental emergencies, including, but not limited to, the identification of potentially infected workers and provision of immediate medical care to exposed, ill or injured workers.
The organization shall also ensure that control measures in place can be demonstrated as being reasonable and proportionate to the scale and nature of the emergency.
Emergency plans shall be effectively communicated to all employees and relevant third parties, and tested, with the intention that everyone is aware of their obligations.
The organization shall ensure that structured and realistic emergency exercises and simulations, including security drills are conducted at regular intervals, based on risk, to test the plans, prepare personnel, and learn from any good practices or deficiencies identified.
The organization shall ensure that in the event of an emergency, adequate contingency measures shall be in place to ensure the safety and security of continued operations.
The organization shall ensure that appropriate data are determined, collected and analyzed to assess the suitability and effectiveness of the biorisk management system and to evaluate where continual improvement of the system can be made.
The organization shall ensure that records, documents and data are established, controlled and maintained to provide evidence of conformity to the requirements of this standard and that they remain legible, readily identifiable and retrievable.
The organization shall ensure that a review of the inventory is conducted at predetermined intervals based on risk and at a level and frequency whereby materials can be accounted for in an appropriate manner.
The organization shall ensure that the measures are put in place to minimize the quantities of biological agents and toxins that make up the inventory.
The organization shall establish and maintain documented procedures to define, record, analyze and learn from accidents and incidents involving biological agents and toxins.
The organization shall ensure that situations that do not conform to the requirements of this standard are identified and controlled to prevent undesirable consequences. Records of the nature of the non-conformity and any subsequent action taken shall be maintained.
The organization shall ensure action is taken to eliminate the causes of non-conformities with the requirements of this standard in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.
The organization shall ensure action is taken to identify and eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential nonconformities.
The organization shall ensure that a programme of inspection and audit is conducted which is appropriate to the risk associated with the facility.
Inspections and audits shall be conducted at planned intervals to determine if the biorisk management system conforms to the documented plans and to the requirements of this standard, and that it is effectively implemented and maintained.
Management responsible for the area being inspected / audited shall ensure that any actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities arising shall include the verification of the actions taken and the reporting of verification results.
Top management shall review the organization’s biorisk management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the system, procedures, policies and objectives. Records from the management review shall be maintained.
