Transfusion Safety and Federal Regulatory Requirements

Question 1

1. Which of the following is responsible for overseeing the
   safety of the nation’s blood supply?
   a. Joint Commission on Accreditation of Healthcare
   Organizations
   b. Food and Drug Administration
   c. College of American Pathologists (CAP)
   d. Occupational Safety and Health Administration

Answer 1

b. Food and Drug Administration

Question 2

2. Where are the regulations for blood and blood components published?
   a. The AABB Technical Manual
   b. CAP inspection checklist
   c. The Code of Federal Regulations
   d. State Inspectional Guidance Documents

Answer 2

c. The Code of Federal Regulations

Question 3

3. What was the important tragedy that led to the regulation
   of biological products?
   a. Three patients contracted hepatitis C following transfusion
   b. A child died following transfusion of hemolyzed red
   blood cells
   c. A group O patient received group A blood
   d. Thirteen children died after receiving diphtheria antitoxin contaminated with tetanus

Answer 3

d. Thirteen children died after receiving diphtheria antitoxin contaminated with tetanus

Question 4

4. What is required to ship blood and blood components
   across state lines (interstate)?
   a. AABB accreditation
   b. State license
   c. CMS certification
   d. Approved biologics license application

Answer 4

d. Approved biologics license application

Question 5

5. Which of the following government organizations inspect blood and blood component manufacturers?
   a. CBER
   b. ORA
   c. CMS
   d. All of the above

Answer 5

c. CMS

Question 6

6. Which of the following is true about CGMP?
   a. CGMP is the minimum current practice for methods
   and facilities used to manufacture a drug to ensure
   that it is safe, pure, and potent
   b. The FDA will approve a biologics license application
   if the manufacturer does not have a quality control
   plan
   c. The quality control unit must perform all the quality
   functions
   d. Blood and blood components do not have to be in
   compliance with the drug CGMP regulations

Answer 6

a. CGMP is the minimum current practice for methods
and facilities used to manufacture a drug to ensure
that it is safe, pure, and potent

Question 7

7. A donor calls the blood bank and informs them that
   within a year prior to his donation, he had intimate contact with a person diagnosed with HIV. Which of the following actions is not required by the FDA?
   a. Identify and quarantine all blood and blood components produced from the blood supplied by the
   donor
   b. Report the biological product deviation to CBER if
   the product has been distributed
   c. Enter the donor in a record so that he can be identified and his product not be distributed while he is
   deferred
   d. Notify the AABB

Answer 7

d. Notify the AABB

Question 8

8. A patient dies following transfusion of ABO-incompatible
   blood. To whom should this event be reported?
   a. The Center for Biologics Evaluation and Research
   b. Center for Medicare and Medicaid Services
   c. The AABB central office
   d. The Occupational Safety and Health Administration

Answer 8

a. The Center for Biologics Evaluation and Research

Question 9

9. Which federal agency has the responsibility to routinely
   inspect an unregistered transfusion service that does not
   collect blood?
   a. Food and Drug Administration
   b. Centers for Medicare and Medicaid Services
   c. Occupational Safety and Health Administration
   d. State health department

Answer 9

b. Centers for Medicare and Medicaid Services

Question 10

10. Which of the following is not one of the FDA layers of
    safety?
    a. Donor screening
    b. Biologics License Application
    c. Investigation of manufacturing problems
    d. Testing for relevant transfusion-transmitted infections

Answer 10

b. Biologics License Application