Deck 20: Transfusion Safety and Regulatory Issues

Question 1

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

A)CBER
B)CMS
C)FDA
D)NIH

Answer 1

CBER

Question 2

In the United States,which agency regulates workplace safety?

A)CAP
B)EPA
C)FDA
D)OSHA

Answer 2

OSHA

Question 3

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

A)Biologics Control Act
B)Federal Food and Drugs Act
C)Public Health Service Act
D)Virus-Control Law

Answer 3

Biologics Control Act

Question 4

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

A)Administrative
B)Advisory
C)Deviation
D)Recall

Question 5

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

A)Biological product deviation
B)Fatality
C)Hemovigilance
D)Nonconformance

Question 6

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

A)American Association of Bioanalysts
B)American Medical Technologists
C)Board of Certification of the American Society of Clinical Pathologists
D)College of American Pathologists

Question 7

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?

A)Certification
B)Degree
C)Licensure
D)Registry

Question 8

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

A)Two
B)Three
C)Four
D)Five

Question 9

Which organization publishes Standards for Blood Banks and Transfusion Services?

A)AABB
B)ASCP
C)CAP
D)FDA

Question 10

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

A)CFR title 10
B)CFR title 21
C)CFR title 29
D)CFR title 42

Question 11

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

A)nonwaived
B)waived
C)centralized
D)point-of-collection

Question 12

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

A)Nonwaived
B)Waived
C)Moderate complexity
D)High complexity

Question 13

When was the first license for a blood bank issued?

A)1902
B)1934
C)1946
D)1962

Question 14

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

A)A2LA
B)AABB
C)CAP
D)OLA

Question 15

Under which regulatory agency was the Bureau of Biologics housed?

A)AMA
B)CMS
C)FDA
D)NIH

Question 16

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

A)Class I
B)Class II
C)Class III
D)Class IV

Question 17

Which organization enforces CLIA?

A)AMA
B)CBER
C)CMS
D)FDA

Question 18

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

A)American Association of Bioanalysts
B)American Association of Blood Banks
C)Board of Certification of the American Society of Clinical Pathologists
D)College of American Pathologists

Question 19

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

A)1976
B)1981
C)1985
D)1990

Question 20

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

A)Level I
B)Level II
C)Level III
D)Level IV