Regulations and Standards

Question 1

1. The AABB performs which of the following activities?
   a. accreditation
   b. inspection
   c. education
   d. all of the above

Answer 1

d. all of the above

Question 2

2. What does TJC stand for?

Answer 2

The Joint Commission

Question 3

3. “CLIA” is an abbreviation for the:
   a. Clinical Laboratory Improvement Act
   b. Council of Lower Intestinal Ailments
   c. Cytokine Linked ImmunoAssay
   d. Council for Laboratory Improvement and Advancement

Answer 3

a. Clinical Laboratory Improvement Act

Question 4

4. Centers for Medicare and Medicaid Services certification
   is required for
   a. physician office clinical laboratories
   b. blood bank testing laboratories
   c. hospital clinical laboratories
   d. all of the above

Answer 4

d. all of the above

Question 5

5. The College of American Pathologists is a major provider
   of
   a. physicians to serve as inspectors
   b. diagnostic test kits
   c. proficiency tests
   d. clinical pathologists in America

Answer 5

c. proficiency tests

Question 6

6. Blood products are regulated by the Food and Drug Administration (FDA), being classified as both a _____and a _____.

Answer 6

drug, biologic

Question 7

7. The Public Health Service Act requires that those organizations involved in the manufacture of blood products
   to be offered for sale obtain
   a. an establishment license
   b. a sales permit
   c. a psychological examination
   d. none of the above

Answer 7

a. an establishment license

Question 8

8. A Form FDA 483 is used as
   a. a list of FDA investigator observations
   b. a Notice of Inspection by the FDA
   c. a list of the fire codes, provided by your fire department
   d. a warning to revoke your establishment license

Answer 8

a. a list of FDA investigator observations

Question 9

9. The objective of the FDA is to ensure the ________,_______, ________, ________, and __________ of blood and blood products

Answer 9

safety, quality, identity, purity, potency

Question 10

10. A product “recall”
    a. is used to remove violative product from the market
    b. can be issued against one or several lots
    c. is classified according to the health risk involved
    d. all of the above

Answer 10

d. all of the above

Question 11

11. A “seizure” is an FDA enforcement action taken against
    a. a corporation or its individuals
    b. the chief executive officer
    c. donors exhibiting adverse reactions
    d. violative products

Answer 11

d. violative products

Question 12

12. A “Section 305” hearing provides an opportunity for an
    individual to
    a. rectify violations identified by the FDA
    b. discuss the 482
    c. present his or her case to the FDA, before initiation
    of criminal proceedings
    d. apply for a position as Responsible Head

Answer 12

c. present his or her case to the FDA, before initiation

Question 13

13. Which series of the following International Organization for Standardization standards is most applicable to
    blood banks?
    a. 9001
    b. 9002
    c. 9003
    d. 9005

Answer 13

b. 9002