3.2 Quality system for clinical transfusion

Essential elements include:

Leadership

  • Management demonstrates commitment to quality
  • Responsibility for quality is clearly assigned
  • Resources are available
  • There is an effective hospital transfusion committee or equivalent

Standards or specifications

  • There are explicit statements of what a product should be or a process should achieve

Documentation

  • There are written instructions for doing each job
  • There are records to show whether the job has been done correctly

Change control

Changes in procedures are introduced in a controlled fashion and proper records are maintained

Evaluation or Audit

  • Performance is independently assessed

Staff Training and Assessment

  • Staff are taught what to do and why it is important
  • Their knowledge and competence is assessed

Quality Improvement

  • There is a culture of learning from errors and acting on the lessons learned