Monday, 3 February 2025

An Overview on Hemovigilance - Fact and Fiction | Chapter 7 | Medical Research and Its Applications Vol. 7


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.

 

Author (s) Details

Cees Th. Smit Sibinga
International Development of Transfusion Medicine, University of Groningen, Netherlands. IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn, Netherlands.

Please see the book here:- https://doi.org/10.9734/bpi/mria/v7/795

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