Question 1

What is the function of the CBER?

Accepted Answer

A)  To monitor continuing education at designated facilities 
B)  To issue federal licenses to establishments that are manufacturing biological products 
C)  To issue certification to medical technologists 
D)  None of the above 
A)  To monitor continuing education at designated facilities 
B)  To issue federal licenses to establishments that are manufacturing biological products 
C)  To issue certification to medical technologists 
D)  None of the above B

Question 2

Which FDA center regulates therapeutic biological products?

Accepted Answer

A)  CBER 
B)  CDER 
C)  OBRR 
D)  OCBQ 
A)  CBER 
B)  CDER 
C)  OBRR 
D)  OCBQ B

Question 3

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

Accepted Answer

A)  To recall all banked units 
B)  To disclose the name of the deceased 
C)  To determine if appropriate corrective action has been taken to prevent recurrence 
D)  To report all reagent lot numbers used in typing deceased patient 
A)  To recall all banked units 
B)  To disclose the name of the deceased 
C)  To determine if appropriate corrective action has been taken to prevent recurrence 
D)  To report all reagent lot numbers used in typing deceased patient C

Question 4

All of the following is correct regarding recovered plasma except:

Accepted Answer

A)  it is derived from single units of expired whole blood. 
B)  it is derived from single units of unexpired whole blood. 
C)  it is a licensed source material used in the manufacturing of licensed products. 
D)  it is an unlicensed source material used in the manufacturing of licensed products. 
A)  it is derived from single units of expired whole blood. 
B)  it is derived from single units of unexpired whole blood. 
C)  it is a licensed source material used in the manufacturing of licensed products. 
D)  it is an unlicensed source material used in the manufacturing of licensed products.

Question 5

The establishment license and one product license are issued simultaneously by the CBER.

Accepted Answer

A) True 
 B)False

Question 6

FDA proposed regulations are published in .

Accepted Answer

A)  Transfusion Medicine 
B)  The Federal Register 
C)  AABB Standards 
D)  Immunohematology 
A)  Transfusion Medicine 
B)  The Federal Register 
C)  AABB Standards 
D)  Immunohematology

Question 7

Which FDA center regulates biological and related devices?

Accepted Answer

A)  CBER 
B)  CDER 
C)  OBRR 
D)  OCBQ 
A)  CBER 
B)  CDER 
C)  OBRR 
D)  OCBQ

Question 8

Establishments that hold U.S. licenses for a biological product can:

Accepted Answer

A)  ship products interstate and internationally for sale or exchange. 
B)  only ship and sell products interstate. 
C)  market multiple trademark for their product. 
D)  All of the above 
A)  ship products interstate and internationally for sale or exchange. 
B)  only ship and sell products interstate. 
C)  market multiple trademark for their product. 
D)  All of the above

Question 9

In a situation where it is thought a product will cause serious adverse health consequences or death, what type of recall will be issued?

Accepted Answer

A)  Class I 
B)  Class II 
C)  Class III 
D)  None of these 
A)  Class I 
B)  Class II 
C)  Class III 
D)  None of these

Question 10

Which of the following is true concerning a contract manufacturer?

Accepted Answer

A)  Contract manufacturers are employed by another manufacturer to perform some part of the product's manufacturing. 
B)  Contract manufacturer is under the direct control of the original product manufacturer. 
C)  Contract manufacturers do not need to register with the FDA because they are not the originating manufacture. 
D)  All of these 
A)  Contract manufacturers are employed by another manufacturer to perform some part of the product's manufacturing. 
B)  Contract manufacturer is under the direct control of the original product manufacturer. 
C)  Contract manufacturers do not need to register with the FDA because they are not the originating manufacture. 
D)  All of these

Question 11

Blood grouping reagents are considered medical devices according to the CBER.

Accepted Answer

A) True 
 B)False

Question 12

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?

Accepted Answer

A)  Vaccine 
B)  Blood component 
C)  Antitoxin 
D)  Virus 
A)  Vaccine 
B)  Blood component 
C)  Antitoxin 
D)  Virus

Question 13

Which of the following prevents interstate shipment of biological products by an establishment?

Accepted Answer

A)  An FDA warning letter 
B)  An FDA suspension 
C)  FDA form 483 
D)  Short supply 
A)  An FDA warning letter 
B)  An FDA suspension 
C)  FDA form 483 
D)  Short supply

Question 14

Which of the following is are included in the FDA's five layers of safety?

Accepted Answer

A)  Donor screening and review of deferral records 
B)  Blood testing and quarantine of donor unit 
C)  Investigation of all problems and deficiencies 
D)  All of these 
A)  Donor screening and review of deferral records 
B)  Blood testing and quarantine of donor unit 
C)  Investigation of all problems and deficiencies 
D)  All of these

Question 15

Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?

Accepted Answer

A)  Quality control 
B)  Reproducibility 
C)  Delta check 
D)  Good manufacturing practices 
A)  Quality control 
B)  Reproducibility 
C)  Delta check 
D)  Good manufacturing practices

Question 16

In a situation where there is a remote chance that a product will cause temporary or medically reversible adverse health consequences, what type of recall will be issued?

Accepted Answer

A)  Class I 
B)  Class II 
C)  Class III 
D)  None of these 
A)  Class I 
B)  Class II 
C)  Class III 
D)  None of these

Question 17

In a situation where exposure to a product is not likely to cause adverse health consequences, what type of recall will be issued?

Accepted Answer

A)  Class I 
B)  Class II 
C)  Class III 
D)  None of these 
A)  Class I 
B)  Class II 
C)  Class III 
D)  None of these

Question 18

One change that occurred under the FDA for oversight of biologics was that the FD&C Act now labeled biologics as:

Accepted Answer

A)  blood products. 
B)  drugs. 
C)  reagents. 
D)  growth factors. 
A)  blood products. 
B)  drugs. 
C)  reagents. 
D)  growth factors.

Question 19

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

Accepted Answer

A)  PHS Act of 1902. 
B)  Product Safety Act of 1902. 
C)  Biologics Control Act of 1902. 
D)  none of the above. 
A)  PHS Act of 1902. 
B)  Product Safety Act of 1902. 
C)  Biologics Control Act of 1902. 
D)  none of the above.

Question 20

A drug is considered adulterated if the methods used to manufacture it do not conform with current good manufacturing processes.

Accepted Answer

A) True 
 B)False

Exam 27: Transfusion Safety and Federal Regulatory Requirements

What is the function of the CBER?

Which FDA center regulates therapeutic biological products?

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

All of the following is correct regarding recovered plasma except:

The establishment license and one product license are issued simultaneously by the CBER.

FDA proposed regulations are published in .

Which FDA center regulates biological and related devices?

Establishments that hold U.S. licenses for a biological product can:

In a situation where it is thought a product will cause serious adverse health consequences or death, what type of recall will be issued?

Which of the following is true concerning a contract manufacturer?

Blood grouping reagents are considered medical devices according to the CBER.

Which of the following prevents interstate shipment of biological products by an establishment?

Which of the following is are included in the FDA's five layers of safety?

Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?

In a situation where there is a remote chance that a product will cause temporary or medically reversible adverse health consequences, what type of recall will be issued?

In a situation where exposure to a product is not likely to cause adverse health consequences, what type of recall will be issued?

One change that occurred under the FDA for oversight of biologics was that the FD&C Act now labeled biologics as:

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

A drug is considered adulterated if the methods used to manufacture it do not conform with current good manufacturing processes.

Red Blood Cells and Platelet Preservation: Historical Perspectives and Current Trends

Basic Genetics

Fundamentals of Immunology

Concepts in Molecular Biology

The Antiglobulin Test

The Abo Blood Group System

The Rh Blood Group System

Blood Group Terminology and Common Blood Groups

Uncommon Blood Groups

Detection and Identification of Antibodies

Pre-Transfusion Testing

Blood Bank Technologies and Automation

Donor Selection

Transfusion-Transmitted Diseases

Component Preparation

Transfusion Therapy

Adverse Effects of Blood Transfusion

Apheresis

Cellular Therapy in the Transplant Setting

Hemolytic Disease of the Fetus and Newborn

Autoimmune Hemolytic Anemias

Tissue Banking As Part of the Transfusion Service

The Hla System

Relationship Testing

Quality Management

Patient Blood Management

Laboratory Information Systems in the Blood Bank

Medicolegal and Ethical Aspects of Providing Blood Collection and Transfusion Services

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