Question 1

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 2

Which of the following is NOT included in the FDA's five layers of safety?

Accepted Answer

A)  Competency testing of personnel 
B)  Donor screening and blood testing 
C)  Reviewing records of donor deferral 
D)  Quarantine of donor blood 
A)  Competency testing of personnel 
B)  Donor screening and blood testing 
C)  Reviewing records of donor deferral 
D)  Quarantine of donor blood

Question 3

In what year did the FDA take over biologics regulation?

Accepted Answer

A)  1976 
B)  1980 
C)  1972 
D)  1985 
A)  1976 
B)  1980 
C)  1972 
D)  1985

Question 4

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 5

What is contained in Form FDA-483?

Accepted Answer

A)  Objectionable conditions noted by an FDA inspector 
B)  An FDA checklist used by inspectors 
C)  A list of blood banks that perform in-house viral testing 
D)  A list of certified FDA inspectors 
A)  Objectionable conditions noted by an FDA inspector 
B)  An FDA checklist used by inspectors 
C)  A list of blood banks that perform in-house viral testing 
D)  A list of certified FDA inspectors

Question 6

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 7

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 8

Under the regulated products section 21 CFR 607.20(a), who needs to register with the FDA?

Accepted Answer

A)  The originating manufacturer 
B)  Contract manufacturers who produce the product for the originating manufacturer 
C)  Contract manufacturers who only perform one step of the manufacturing process 
D)  All of these 
A)  The originating manufacturer 
B)  Contract manufacturers who produce the product for the originating manufacturer 
C)  Contract manufacturers who only perform one step of the manufacturing process 
D)  All of these

Question 9

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 10

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 11

Which office performs FDA postmarket inspections of blood and blood component manufacturing facilities?

Accepted Answer

A)  OBRR 
B)  OCBQ 
C)  ORA 
D)  None of these 
A)  OBRR 
B)  OCBQ 
C)  ORA 
D)  None of these

Question 12

Upon the event of an adverse reaction that results in a transfusion-related fatality, the CBER must be notified within what time frame?

Accepted Answer

A)  24 hours 
B)  7 days 
C)  30 days 
D)  Not necessary to contact the CBER but must contact the FDA 
A)  24 hours 
B)  7 days 
C)  30 days 
D)  Not necessary to contact the CBER but must contact the FDA

Question 13

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?

Accepted Answer

A)  Joint Commission 
B)  AABB 
C)  CAP 
D)  CBER 
A)  Joint Commission 
B)  AABB 
C)  CAP 
D)  CBER

Question 14

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 postmarket 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 postmarket stability 
D)  To rewrite employee job descriptions as needed

Question 15

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 16

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.

Exam 27: Transfusion Safety and Federal Regulatory Requirements

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

Which of the following is NOT included in the FDA's five layers of safety?

In what year did the FDA take over biologics regulation?

The short supply agreement is between the blood establishment and:

What is contained in Form FDA-483?

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

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

Under the regulated products section 21 CFR 607.20(a), who needs to register with the FDA?

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

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

Which office performs FDA postmarket inspections of blood and blood component manufacturing facilities?

Upon the event of an adverse reaction that results in a transfusion-related fatality, the CBER must be notified within what time frame?

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?

What is the primary focus of quality assurance?

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

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

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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