Guidance on Centralization of blood donation testing and processing

Preface

The purpose of a national blood system is to ensure timely access to quality, safe and sufficient supplies of blood and blood components for all the patients needing transfusion. However, many low- and middle-income countries are still unable to provide sufficient supplies of whole blood and blood components for patients at all times or in all geographical locations. Vulnerable groups in these countries, such as women with peripartum haemorrhage and children with anaemia from malaria, are often the worst affected by insufficient or unsafe blood supplies. A major barrier to the achievement of universal access to safe blood transfusion in these countries is their ineffective and inefficient blood supply systems. These systems are often fragmented, composed of many small-scale blood establishments, operated by multiple players and have varying levels of performance owing to resource and infrastructure limitations. Experience in many countries has demonstrated that a nationally coordinated and effectively regulated network of blood establishments, in which key functions are centralized, has many advantages. Centralization optimizes use of resources, reduces overall costs, promotes compliance with quality and safety standards, improves patient access to the most suitable blood components for transfusion, and enhances resilience in emergency situations that affect blood supply or safety. The World Health Organization’s Action framework to advance universal access to safe, effective and quality-assured blood products 2020–2023 recommends countries to consolidate blood donation testing and processing in appropriate facilities. Such facilities should have effectively implemented quality systems to overcome the shortcomings that often exist in decentralized blood systems that are highly fragmented and to achieve the strategic objective of building functioning and efficiently managed blood services. Guidance on centralization of blood donation testing and processing provides a strategic framework to assist Member States in deciding whether to centralize blood donation testing and processing and how to choose the most suitable centralization model for the unique characteristics of the blood system of each country. The guidance document explains the key steps in planning a blood establishment to centralize activities. It also offers practical guidance on implementing quality, risk management and information management systems, and on managing the infrastructure, human and financial resources necessary for a blood establishment that will perform centralized blood donation testing and processing. Centralization of blood donation processing can play an important role in increasing the availability of quality plasma for fractionation.

This guidance is complementary to the Guidance on increasing supplies of plasma-derived medicinal products in low- and middle- ncome countries through fractionation of domestic plasma. The guidance document provides a strategic framework to assist Member States in increasing their volume of quality plasma suitable for fractionation to help address unmet needs for plasma derived medicinal products.