Question 1

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 2

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

Accepted Answer

A) True 
 B)False

Question 3

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 4

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

Question 5

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 6

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

In what year did the FDA take over biologics regulation?

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

What is contained in Form FDA-483?

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

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?

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

Exam 24: Transfusion Safety and Federal Regulatory Requirements

In what year did the FDA take over biologics regulation?

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

What is contained in Form FDA-483?

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

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?

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