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