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Blood centers and hospital blood banks are regulated as medical laboratories and therefore must be in compliance with state and federal requirements. In this chapter, we identify the regulatory agencies that provide this oversight and review key regulatory concepts including inspections, proficiency testing, licensure and registration, complexity of laboratory testing, deviations and recalls, and quality assurance of blood products. By presenting hypothetical examples from clinical practice, we illustrate these important concepts related to quality and also introduce concepts related to disaster management. |
