Quality in blood components – it all starts with the donation

Abstract

Blood transfusion is not risk free, so should only be prescribed when it is in the patient's best interest to do so. Blood establishments have a recognized obligation to promote optimal use of blood and blood components while minimizing risk to the health of the recipient. Processes are therefore focused on producing quality components that are efficacious and safe. In manufacturing processes, the quality of final products is heavily dependent on the quality and reliability of the starting materials, and therefore, control of these materials to reduce variation is a critical quality assurance activity. The starting material or primary product for the manufacture of blood components is the blood donation. If the quality of that donation is not assured, the efficacy and safety of the blood components manufactured from it will be potentially compromised no matter how good the rest of the manufacturing process may be. The challenge, however, is that blood is a biological material and collection is subject to a number of variations: Donations are collected from donors of various ages with different demographics, health profiles and behaviours. The donations have different characteristics, for example volume of donation, numbers of platelets, levels of immunoglobulin, blood group antibodies. The collection process depends largely on manual procedures with the exception of apheresis collections. Donations may be collected, stored and transported under varying environmental conditions. Because of these variations, controlling the quality and consistency of the primary blood donation can be more challenging than controlling starting material for an industry such as pharmaceutical manufacture. In recent years, there have been a number of developments aimed at improving the quality of the blood donation. These have largely focused on controlling and reducing variations in the process steps that are most likely to have an impact on quality or safety. These are called critical control points, and for the donation process, it includes the following: Selection of blood donors, Collection of the donation, Handling and storage of the donation, Transport of the donation to the processing centre. A number of the developments are new technologies that automate the critical control points as far as possible, such as decision support systems to improve the consistency of interpretation of donor selection guidelines, vein viewer systems that improve the venepuncture process and transport containers that can control temperatures. There have also been developments of internationally accepted component standards and principles of good manufacturing practices that provide the framework for quality in blood establishments and have been able to drive significant improvements in processes and component quality. In combination, these recent developments can provide a high degree of assurance that the starting point for the manufacture of safe and efficacious blood components will be a quality donation.