Exam 20: Transfusion Safety and Regulatory Issues

Which law was the first American legislation to deal with biologics?

All of the following are categories of enforcement action that the FDA can use except

Under which regulatory agency was the Bureau of Biologics housed?

Which organization enforces CLIA?

In the United States,which agency regulates workplace safety?

Which organization publishes Standards for Blood Banks and Transfusion Services?

All deaths in the United States that are related to blood donation or blood transfusion must be reported to

In North America,the three organizations currently most recognized for accrediting to ISO 15189 standards are all of the following except

When was the first license for a blood bank issued?

A full inspection of all systems is designated as what level of inspection?

Which organization represents one of the most common voluntary accreditations that apply to medical laboratories?

Which of the following is usually issued by a professional society to indicate that a person has met a set of qualifications and is therefore qualified to perform a particular job?

Routine inspections include an evaLuᵃtion of how many layers of blood safety?

What report must be submitted if an error could affect the safety,potency,or purity of a distributed blood product?

Most laboratory tests performed in blood banks and transfusion services are _________ tests.

Which code of federal regulations contains the rules for blood product safety?

Under which class of medical devices would reagents for diagnostic tests for HIV,HCV,and HBV fall?

In what year was the first test used to screen blood donors for HIV licensed?

Generally over-the-counter tests and some point-of-collection tests are classified as

All of the following organizations offer certification for clinical laboratory scientists except