|Title||Regulation, health and safety in the practice of reproductive science|
By the end of the training period trainees will, in respect to regulation and health and safety in the practice of reproductive science, be able to:
- analyse, synthesise, evaluate and apply knowledge
- perform a range of technical and clinical skills and procedures
- demonstrate the attitudes and behaviours necessary for professional practice as a consultant clinical scientist dealing with the complexities, uncertainties and tensions of professional practice at this level.
- legislation regarding assisted conception both nationally and internationally
- health and safety issues both locally and nationally in order to practise safely in a laboratory, clinical or other settings
- offer advice on safe practice;
- risk assessments for dealing with potential pathogens and the requirements for handling such pathogens,
- risk assessments of laboratory practices,
- categorisation of normality of gametes and embryos and their suitability for clinical use.
Trainees will also be expected to perform risk assessments and develop, refine and evaluate health and safety precautions relating to patient management and demonstrate the attitudes and behaviours necessary for the role of a clinical scientist.
Knowledge and understanding
By the end of the training period the trainee will be able to demonstrate the ability to analyse, evaluate and synthesise relevant knowledge and its application to their professional practice in relation to:
- the current legislative framework underpinning assisted conception and health and safety (H&S) at work, and specific legislation and guidance relating to safety in handling biological specimens and laboratory working practices, including:
- professional codes of practice
- the role of quality management systems
- validation of equipment and procedures/practice
- ethical issues, including donation and cryopreservation
- the need for informed consent
- identification of actions that are prohibited by regulations
- ethical conduct
- clinical governance
- the role of audit
- record keeping
- identity checking and witnessing
- cross-border reproductive care both within and outside the EU
- external quality assurance and internal quality assurance
- Health and Safety at Work Act (1974)
- Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR)
- Control of Substances Hazardous to Health (COSHH) Regulations (2002)
- Management of Health and Safety at Work Regulations (1999)
- Transport of Infectious Substances (2011) guidance
- Biological agents: Managing the risks in laboratories and healthcare premises (HSE)
- Safe disposal of clinical waste (1999) guidance
- EU Tissue and Cells Directive (2004/23/EC)
- EU Tissue and Cells Directive (2006/17/EC)
- EU Tissue and Cells Directive (2006/86/EC)
- Human Fertilisation and Embryology Act (2008 as amended)
- reporting of adverse events and incidents
- National Patient Safety Agencyaction relating to adverse incidents and events
- Medicines and Healthcare Products Regulatory Agency.
Technical and clinical skills
By the end of the training period the trainee will be able to demonstrate a critical understanding of current relevant research, theory and knowledge and its application to the performance of the following technical procedures and laboratory skills to:
- perform an appropriate risk assessment, validation or audit when required for all procedures undertaken in the laboratory, in areas related to laboratory practice, and in the healthcare setting.
By the end of the training period the trainee will be able to apply knowledge to perform the clinical skills necessary to manage under supervision:
- the need for legislative and health and safety precautions in relation to patient management.
Attitudes and behaviours
This module has no attitude and behaviours information.