Quality Management in the Blood Bank

Question 1

1. A compliance program:
   a. Evaluates how effectively the facility meets regulatory
   requirements
   b. Always identifies quality problems
   c. Is part of quality control
   d. Is an evaluation of efficiency

Answer 1

a. Evaluates how effectively the facility meets regulatory
requirements

Question 2

2. The quality system essentials are applied to:
   a. The blood bank’s management staff
   b. Blood bank quality control activities
   c. Blood component manufacturing
   d. The blood bank’s path of workflow

Answer 2

d. The blood bank’s path of workflow

Question 3

3. cGMP refers to:
   a. Regulations pertaining to laboratory safety
   b. Validation of testing
   c. Nonconformance reporting
   d. Manufacturing blood components

Answer 3

d. Manufacturing blood components

Question 4

4. Internal and external failure costs are:
   a. Readily identifiable in facility reports
   b. Controlled through prevention and appraisal
   c. Built into the facility’s operating budget
   d. Part of prevention and appraisal

Answer 4

b. Controlled through prevention and appraisal

Question 5

5. Which one statement below is correct?
   a. A process describes how to perform a task
   b. A procedure simply states what the facility will do
   c. A procedure informs the reader how to perform a task
   d. A policy can be flowcharted

Answer 5

c. A procedure informs the reader how to perform a task

Question 6

6. A blank form is a:
   a. Record
   b. Procedure
   c. Flowchart
   d. Document

Answer 6

d. Document

Question 7

7. An example of a remedial action is:
   a. Applying the problem-solving process
   b. Starting a process improvement team
   c. Resolving the immediate problem
   d. Performing an internal audit

Answer 7

c. Resolving the immediate problem

Question 8

8. The DMAIC methodology is used for:
   a. Problem resolution
   b. Process control
   c. Validation
   d. Auditing

Answer 8

a. Problem resolution

Question 9

9. ___________________________ is a set of planned
   actions that ensure that systems and elements that influence the quality of service are working as expected.
   a. Quality control
   b. Quality assurance
   c. Quality indicator
   d. Quality management system

Answer 9

b. Quality assurance

Question 10

10. The Centers for Medicare and Medicaid Services (CMS)
    developed an alternative quality control option, an
    individualized quality control plan (IQCP). How is
    the minimum frequency of running quality controls
    determined?
    a. Through risk assessment
    b. By the quality control plan
    c. After quality assessment
    d. By the manufacturer

Answer 10

d. By the manufacturer