Title Advanced Quality Management and Clinical Governance
Type Stage Two
Code HLS200
Requirement Compulsory

Module objective

By the end of the training period with respect to advanced quality management and clinical governance, the trainee will be able to:

  • analyse, synthesise, critically evaluate and apply knowledge
  • perform, adapt and master 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

Knowledge and understanding

By the end of the training period the trainee will be able to demonstrate the ability to analyse, critically evaluate and synthesise relevant knowledge and its application to their professional practice in relation to:

  • the criteria and process for accreditation and licensing standards applicable to a transfusion laboratory including:
    • Blood Safety and Quality Regulations
    • CPA standards
    • ISO15189
    • IVDD/CE marking
  • the role of regulatory bodies including
    • MHRA
    • CQC
    • Human Tissue Authority
    • NICE
  • change management including validation processes
  • internal and external quality assessment schemes
  • risk management including risk identification, assessment, avoidance and control
  • the principles and application of clinical governance

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 a range of technical procedures and laboratory skills and will be able to:

  • exercise the key components of good clinical governance including:
    • clinical audit
    • education, training and continuing professional development
    • risk management
    • evidence-based care and effectiveness
    • patient-oriented care and involvement
  • perform audits against defined standards identifying non-conformances and proposing and implementing remediation plans and evaluating the impact of the changes made
  • maintain robust procedures for Quality Assurance and Quality
  • critically review quality incidents and near misses, and develop and implement corrective and preventative actions
  • undertake and evaluate trend analyses
  • interpret and respond to outcomes of external quality assessment schemes
  • implement and manage change to improve practice in accordance with change management principles without compromising safety or compliance
  • commission and perform clinical audits, deriving plans to improve patient outcomes
  • report incidents internally and externally including SABRE and SHOT

By the end of the training period the trainee will be able to apply knowledge of advanced quality management and clinical governance to perform, adapt and master the clinical skills necessary to:

  • take risk-based decisions
  • deliver clinical advice in the context of conflicting and changing evidence without compromising compliance
  • explain the impact of changes to testing strategy and/or service delivery

Attitudes and behaviours

This module has no attitude and behaviours information.


Code Title Action
HLS1-6-20 Clinical and Laboratory Transfusion [v1] View