Question 1

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. C

Question 2

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. D

Question 3

In 1970, the Public Health Service Act was expanded to include:

Accepted Answer

A)  provisions for licensing products. 
B)  blood and blood components and derivatives. 
C)  guidelines for suspending licenses for violations. 
D)  authorization for facility inspection. 
A)  provisions for licensing products. 
B)  blood and blood components and derivatives. 
C)  guidelines for suspending licenses for violations. 
D)  authorization for facility inspection. B

Question 4

What protocol is followed for licensed products generated at a different site from the original licensed site or establishment?

Accepted Answer

A)  Product license is automatically transferred from site to site. 
B)  An amendment is filed to the product license application. 
C)  A separate product license must be issued for each additional site. 
D)  None of the above 
A)  Product license is automatically transferred from site to site. 
B)  An amendment is filed to the product license application. 
C)  A separate product license must be issued for each additional site. 
D)  None of the above

Question 5

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 6

Which of the following would constitute short supply and an exemption from licensure?

Accepted Answer

A)  RBCs used in the manufacturing of check cells 
B)  Recovered plasma used in the making of platelets 
C)  Recovered plasma used in the manufacturing of factor VIII 
D)  Whole blood used in the manufacturing of hemoglobin substitute 
A)  RBCs used in the manufacturing of check cells 
B)  Recovered plasma used in the making of platelets 
C)  Recovered plasma used in the manufacturing of factor VIII 
D)  Whole blood used in the manufacturing of hemoglobin substitute

Question 7

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

Question 8

All of the following is covered under the PHS Act except:

Accepted Answer

A)  penalty for violation. 
B)  labeling requirements. 
C)  inspection requirements. 
D)  budget control. 
A)  penalty for violation. 
B)  labeling requirements. 
C)  inspection requirements. 
D)  budget control.

Question 9

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

Question 10

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 11

What is the purpose of a prelicense inspection by the CBER?

Accepted Answer

A)  To order mandatory injunctions 
B)  To determine the firm's readiness for an unannounced inspection 
C)  To determine the firm's ability to operate in compliance with applicable regulations 
D)  None of the above 
A)  To order mandatory injunctions 
B)  To determine the firm's readiness for an unannounced inspection 
C)  To determine the firm's ability to operate in compliance with applicable regulations 
D)  None of the above

Question 12

The FDA-directed civil action that calls for removal of products from distribution channels is known as:

Accepted Answer

A)  injunction. 
B)  seizure. 
C)  prosecution. 
D)  quarantine. 
A)  injunction. 
B)  seizure. 
C)  prosecution. 
D)  quarantine.

Question 13

What is the primary focus of quality assurance?

Accepted Answer

A)  To place blame on employees who make recurring errors 
B)  To amend the system, procedure, or standard operating procedures, if deemed faulty 
C)  To analyze post-market stability 
D)  To rewrite employee job descriptions as needed 
A)  To place blame on employees who make recurring errors 
B)  To amend the system, procedure, or standard operating procedures, if deemed faulty 
C)  To analyze post-market stability 
D)  To rewrite employee job descriptions as needed

Question 14

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

Accepted Answer

A) True 
 B)False

Question 15

The short supply agreement is between the blood establishment and:

Accepted Answer

A)  the broker. 
B)  the final product manufacturer. 
C)  the donor. 
D)  none of the above. 
A)  the broker. 
B)  the final product manufacturer. 
C)  the donor. 
D)  none of the above.

Question 16

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 17

Which of the following provides just cause for a product recall by the FDA?

Accepted Answer

A)  The donor blood pressure reading was omitted in donor screening. 
B)  An A-positive packed red blood cell unit was labeled as an A-negative packed red blood cell unit. 
C)  An autologous unit was found reactive for anti-HBc. 
D)  A therapeutic whole blood unit had a hematocrit of greater than 80%. 
A)  The donor blood pressure reading was omitted in donor screening. 
B)  An A-positive packed red blood cell unit was labeled as an A-negative packed red blood cell unit. 
C)  An autologous unit was found reactive for anti-HBc. 
D)  A therapeutic whole blood unit had a hematocrit of greater than 80%.

Question 18

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 19

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 20

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

Exam 24: Transfusion Safety and Federal Regulatory Requirements

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

All of the following is correct regarding recovered plasma except:

In 1970, the Public Health Service Act was expanded to include:

What protocol is followed for licensed products generated at a different site from the original licensed site or establishment?

FDA proposed regulations are published in ________.

Which of the following would constitute short supply and an exemption from licensure?

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

All of the following is covered under the PHS Act except:

What is the function of the CBER?

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

What is the purpose of a prelicense inspection by the CBER?

The FDA-directed civil action that calls for removal of products from distribution channels is known as:

What is the primary focus of quality assurance?

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

The short supply agreement is between the blood establishment and:

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

Which of the following provides just cause for a product recall by the FDA?

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

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

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 the Other Blood Groups

Detection and Identification of Antibodies

Pre-Transfusion Testing

Overview of the Routine Blood Bank Laboratory

Other Technologies and Automation

Donor Screening and Component Preparation

Apheresis

Transfusion Therapy

Cellular Therapy

Transfusion-Transmitted Diseases

Hemolytic Disease of the Fetus and Newborn

Autoimmune Hemolytic Anemias

The Hla System

Relationship Testing

Quality Management

Utilization Management

Laboratory Information Systems

Medicolegal and Ethical Aspects of Providing Blood Collection and Transfusion Services

Tissue Banking: A New Role for the Transfusion Service

Filters