Preface
Blood transfusion is a key part of modern health care. All blood products must be safe, clinically effective, of appropriate and consistent quality, and available in a timely manner. Every blood establishment (BE) should put in place an effective quality system to ensure the safety of blood products. The quality system should cover all aspects of the BE’s activities and ensure traceability, from the recruitment and selection of blood donors to the transfusion of blood and blood products to patients. For a BE to establish and sustain an effective quality system, it needs to be clearly defined, structured and organized. It must also be tailored to the activities of the BE and comply with national standards and regulatory requirements. As well as management commitment and support, staff motivation and buy-in are critical to success. The BE must therefore be able to mobilize and utilize available resources effectively to implement the quality system.
This includes harnessing available tools and programmes, such as those for external quality assessment, surveillance and vigilance, as well as existing quality auditing and inspection programmes, and use of International Biological Reference Materials. World Health Organization (WHO) quality assurance guidelines and the recommendations of other technical documents related to quality assurance of blood products should also be applied. Ensuring quality is a continuous process, and, therefore, assessment of effectiveness of the quality system should be done continually. The assessment of BEs can include inspection of their implementation of Good Manufacturing Practices; ongoing collection and analysis of data generated from key activities and their use in quality improvement; establishment of haemovigilance through a system of monitoring, reporting and investigation of adverse incidents related to all blood transfusion activities; joining a programme of regular internal and external audits of the quality system; active participation in appropriate external quality assessment schemes to improve laboratory performance, and joining an accreditation programme. Strategic Objective 3 of the WHO Action framework to advance universal access to safe, effective and quality-assured blood products 2020–2023 aims to achieve functioning and efficiently managed blood services.
To meet this objective, High-Level Outcome 2 is to have a functioning quality system in place along the entire blood transfusion chain. Development and application of this guidance is one of the activities that will assist Member States to implement a functioning quality system in their BEs, which will ensure all activities relating to blood products (including the associated substances and in-vitro diagnostic devices required for these activities) are carried out in a quality-focused manner. Moreover, this guidance will contribute to the thirteenth General Programme of Work, which highlights universal health coverage. This includes appropriate access to affordable and quality-assured medicines, vaccines and health products (including diagnostics and devices, as well as blood and blood products).
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