Existing and recommended legislative framework for a national blood transfusion policy

Blood transfusion contributes to saving millions of lives every year, improves life expectancy, and the quality of life of patients suffering from life-threatening conditions and supports complex medical and surgical procedures. Every country should put in place policies, a legislative framework, systems and structures to ensure the safety, quality, accessibility, and timely availability of blood and blood products to meet the needs of all patients who require transfusion. However, there are numerous situations, particularly in the less developed world, where these prerequisites have barely been implemented. A literature search was done on matching combinations of legislation, regulation, legislation framework, with blood and blood transfusion, which resulted in almost exclusively references with respect to national and international legislation. The Ministry of Health should provide effective leadership and governance in developing a national blood system that is fully integrated into the health-care system. Essential functions of a national blood system include policy formulation, a legislation framework spelling out the principles and boundaries, standard setting, strategic and operational planning, provision of resources and national coordination, and management to ensure an adequate supply of blood and blood products and safe clinical transfusion. The structure of the national blood system will depend on the organization and level of development of the health-care system. However, all critical activities within a national blood system should be coordinated nationally to promote uniform standards, economies-of-scale, consistency in quality and safety of blood and blood products. and best transfusion practices. Keys are formulation and oversight of the implementation of the national blood policy and strategic plan; defining the roles, responsibilities, and accountability of institutions; and setting national standards for blood and blood products, services, processes, and systems; defining requirements for the registration, licensing, and operation.