An Overview on Hemovigilance - Fact and Fiction

Abstract

Performance of the blood system – blood supply and consumption or clinical use in general, follows the 5 key elements of Quality System Management:

1. Organization, (infra-)Structure and Leadership (governance);
2. Standards, References and Guidelines (technical and quality);
3. Documentation (quality pyramid with its 4 levels – 2 managerial and 2 operational);
4. Education (teaching and training, maintaining competency, and developing stewardship);
5. Assessment - monitoring and evaluation (M&E), statistical process control (SPC), hemovigilance.

Hemovigilance, as a quality gatekeeping surveillance tool, is an integral part of the assessment element, based on continuous M&E of what has been done, and whether that matches standards of performance, quality and technical. Statistical process control (SPC), Six Sigma and Safety-I and Safety-II are recommended to trace development, where the track and tracing (T&T) is based on waterproof documentation. Hence, as a matter of fact hemovigilance is an integral part of the blood transfusion chain, a gate keeping tool to sustain overall quality, based on meticulous documentation to secure an optimal track and trace-back of data.