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Modern Blood Banking Study Set 1

Medicine

Quiz 27 :

Transfusion Safety and Federal Regulatory Requirements

Quiz 27 :

Transfusion Safety and Federal Regulatory Requirements

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What is contained in Form FDA-483?
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A

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Why is the Center for Biologics Evaluation and Research (CBER) notified in the case of a transfusion-related fatality?
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C

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The law that began and mandated regulation of biological products in the United States was called:
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C

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According to federal law, what organization must be contacted when a biological deviation occurs in a blood bank and the error has the potential to affect the safety of the product or patient?
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FDA proposed regulations are published in .
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The short supply agreement is between the blood establishment and:
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What is the primary focus of quality assurance?
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One change that occurred under the FDA for oversight of biologics was that the FD&C Act now labeled biologics as:
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In what year did the FDA take over biologics regulation?
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Establishments that hold U.S. licenses for a biological product can:
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Which of the following provides just cause for a product recall by the FDA?
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In 1970, the Public Health Service Act was expanded to include:
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Which of the following prevents interstate shipment of biological products by an establishment?
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Biological products are defined as any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component (or derivative allergenic products) or analogous product applicable to the prevention, treatment, or cure of disease or injuries of man. Which specific product was missing in the original PHS statute?
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Which of the following would constitute short supply and an exemption from licensure?
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All of the following is correct regarding recovered plasma except:
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What is the function of the CBER?
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What protocol is followed for licensed products generated at a different site from the original licensed site or establishment?
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Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?
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The FDA-directed civil action that calls for removal of products from distribution channels is known as:
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