Biological Safety Consultancy
USC’s Biological Safety Consultancy Services aim to provide expert advice and information on work associated with biological agents, including those that have been genetically modified.
Biological Safety Consultancy Services include the provision of :
- Competent Advice
- Policies, Procedures and Guidance
- Risk Assessments
- Audits and Inspections
- Accident / Incident Investigations
To manage your biological safety arrangements effectively you need the services of a competent person. This may be an appointed Biological Safety Officer from within the organisation or an external competent person or a combination of both. These persons must have the knowledge and experience to act as a reliable source of advice.
USC has considerable experience in providing biological safety consultancy. This experience encompasses a wide range of sectors: Healthcare, Higher Education (Universities and Medical Schools), Pharmaceutical and Biotechnology.
We specialise in helping biotech start-ups, and university spin-out companies.
Our consultants have played a key role in developing the biological safety arrangements for a number of NHS Trusts. We specialise in assistance with clinical trials using biological agents. Our microbiologist Sharon Wood, who is head of our safety team, has received an award for her (published) collaborative work with a London teaching trust on gene therapy.
Whatever level of competent advice you need USC will be able to highlight what is good practice. We will offer solutions to assist you to work safely and meet your legal obligations.
How can we help
USC can help you with:
- General biological and genetic modification safety advice
- Regulatory advice eg assistance with notification of premises and activities
- Support and guidance for in-house Biological Safety Officers
- Biosafety and Genetic Modification Safety Committees – set up, attendance, production of reports and papers, terms of reference etc.
- Advice re facilities (existing facilities or plans for new ones)
- Emergency / contingency planning
- Liaison with:
- In-house departments eg Infection Prevention and Control teams
- Professional safety bodies eg IOSH, IIRSM, ISTR and EBSA
- Enforcing agencies eg the Health and Safety Executive (HSE) and the Medicines and Healthcare products Regulatory Agency (MHRA)
- Counter Terrorism Security Advisors (providing advice on the requirements of the Anti-terrorism, Crime and Security Act 2001)
- Trial sponsoring companies (eg assistance with site initiation visits)
Policies, Procedures and Guidance
One of the requirements for an effective biological safety management system is to have suitable and sufficient written policies and procedures in place.
The policies must include what the organisation is going to do, who is responsible for doing it, and the arrangements in place to make it happen. The procedures must include arrangements for registration with competent authorities, provision of appropriate facilities, occupational health arrangements and much more.
USC can assist you to produce all necessary safety documentation as well as review existing documents.
USC can help you with the production and/or review of:
- Procedures (and Standard Operating Procedures)
- Codes of Practice
- Laboratory Rules
Training is a vital part of safety management. The Health and Safety at Work etc. Act 1974 requires employers to provide information, instruction, training and supervision. Providing health and safety information and training helps you to ensure that staff know how to work safely.
USC can design and deliver training, refreshers, briefings and information for:
- All staff – biosafety awareness
- All staff – genetic modification awareness
- Project teams
- Biological Safety Officers
- Estates and Facilities Officers and construction staff (including toolbox talks)
- ‘Core’ groups (eg project teams)
- ‘Peripheral’ groups (e.g. those not expected to be directly involved in trials unless in an emergency such as ITU, CCU, A&E, Duty Managers)
- Key departments such as Pathology, Pharmacy, Occupational Health and R&D
- Support staff eg autoclave operatives, domestic staff, maintenance staff
Risk assessments for use of biological agents are a requirement of the Control of Substances Hazardous to Health Regulations (COSHH) 2002 as amended.
Where these agents are genetically modified their use is also governed by:
- The Genetically Modified Organism (Contained Use) Regulations 2014
- The Genetically Modified Organism (Deliberate Release) Regulations 2002.
USC can help you produce and/or review:
- General risk assessments
- COSHH risk assessments
- GMO risk assessments
Audits and Inspections
Audits and inspections are key to actively monitoring your safety management system. The aims of an audit are to establish if the appropriate arrangements are in place. It will look at risk control systems to see if they exist, are implemented, and consistent with the hazard profile of the organisation. It will check that appropriate workplace precautions are in place.
Our Consultants will examine documentation and hold interviews / discussions with key staff and inspect facilities.
The inspection includes looking at:
- General environmental issues – eg housekeeping, condition of the floors/walls/ceilings etc.
- Work equipment – eg microbiological safety cabinets, incubators, freezers, shakers etc.
- Ergonomics – eg manual handling of large fluid bags, consumables, equipment etc. and laboratory / workstation layout
- Waste management – eg disinfectants, autoclaves, waste routes
A report on good and bad practice with a prioritised action plan will be produced.
USC can carry out:
- Inspections of facilities
- Safety management audits (looking at the overall system)
- Targeted audits (e.g. waste management, procedures for first patient recruited to trial)
We can also assist with:
- Internal audits e.g. from Quality Assurance and Clinical Governance teams
- External audits or inspections e.g. from enforcing agencies, sponsoring companies, clients
The use of biological agents is strictly controlled. Robust systems and procedures must be in place to cover spillages, inoculation injuries and other incidents. In the event of an occurrence it is essential that a full investigation is carried out. The aim of any investigation is to identify the root cause. The results can then be used if necessary, to update policies, practices and procedures to prevent a re-occurrence.
Our consultants are skilled in dealing with such situations in a sympathetic non-confrontational manner. We aim to establish the facts to identify the underlying and root causes. We will refer to any existing risk assessments, training records, standard operating procedures, customs and practice as part of the investigation.
Our reports will recommend learning and action points to prevent or reduce the likelihood of a re-occurrence.
USC can provide:
- Independent accident and incident investigations
- Assistance with reporting under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 2013