Title Quality management
Type Stage Two
Code HLS182
Requirement Compulsory

Module objective

By the end of the training period trainees will, in respect of quality management, be able to:

  • analyse, synthesise, 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, 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 an H&I laboratory
    • CPA
    • EFI
    • HTA
    • WMDA
    • JACIE
  • role of other regulatory bodies including Care Quality Commission (CQC), MHRA, NICE
  • principles of change management including validation processes
  • internal quality assurance
  • external quality assurance
  • quality control
  • risk assessment process.

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 teaching, learning and assessment in order to:

  • perform audit against set of defined standards identifying non-conformance
  • Internal Quality Assurance and Internal Quality Control
  • critically review quality incidents and perform trend analysis
  • perform risk assessments and identifies control measures to mitigate the risk
  • implement and manage change in accordance with change management principles
  • perform clinical audit.

By the end of the training period the trainee will be able to apply knowledge of quality management with respect to:

  • explain to clinical users 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
HLS1-4-20 Histocompatibility & Immunogenetics [v1] View