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Transfusion medicine is a highly regulated industry, and regulatory oversight has and continues to be a major factor in most aspects of operations. Although in the United States, the Food and Drug Administration (FDA) is the primary regulator, a number…
Quality, as defined in the field of blood banking and transfusion medicine, has evolved from a focus on retrospective auditing and review of sampling and testing. This evolution began with a focus on compliance and meeting minimal regulations, standards, and…