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,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in
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the Blood Bank
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MULTIPLE CHOICE nn
1. Which of the following agencies administers the Clinical Laboratory Improvement
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Amendments?
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a. AABB
b. Centers for Medicare and Medicaid Services nn nn nn nn nn
c. OSHA
d. Food and Drug Administration nn nn nn
ANS: n n B
The Centers for Medicare and Medicaid Services administers CLIA, Medicare, Medicaid, and
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HIPAA.
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DIF: Level 1 nn REF: n n p. 3 nn
2. A laboratory technologist decided she would like to bring her lab coat home for laundering
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because it had too many wrinkles when returned by the laboratory’s laundry service. Is this
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practice acceptable?
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a. Yes, if she uses 10% bleach nn nn nn nn nn
b. Yes, if she clears it with her supervisor nn nn nn nn nn nn nn
c. Yes, as long as she removes the coat and does not wear it home
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d. No, because the laboratory is a biosafety level 2, and lab coats may not be
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removed nn
ANS: D n n
Methods of transporting the lab coat and the risk of contamination do not permit health care
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workers to bring lab coats home for cleaning.
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DIF: Level 2 nn REF: n n p. 14 nn
3. Personal protective equipment includes: nn nn nn
a. safety glasses. nn
b. splash barriers. nn
c. masks.
d. All of the above nn nn nn
ANS: D n n
Safety glasses, splash barriers, and masks are types of personal protective devices.
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DIF: Level 1 nn REF: n n p. 14 nn
4. At what point in the employment process should safety training take place?
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a. During orientation and training nn nn nn
b. Following lab training when employees are more familiar with their nn nn nn nn nn nn nn nn nn
nn responsibilities
, c. Following the employees’ first evaluation nn nn nn nn
d. Before independent work is permitted and annually thereafternn nn nn nn nn nn nn
ANS: D n n
The Occupation Safety and Health Administration requires safety training before independent
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work is permitted and annually thereafter.
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DIF: Level 1 nn REF: n n p. 17 nn
5. In safety training, employees must become familiar with all of the following except:
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a. tasks that have an infectious risk. nn nn nn nn nn
b. limits of protective clothing and equipment. nn nn nn nn nn
c. the appropriate action to take if exposure occurs.
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d. how to perform cardiopulmonary resuscitation on a donor or other employee.
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ANS: D n n
The Occupational Safety and Health Administration requirements include all of those listed
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except cardiopulmonary resuscitation.
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6. Blood irradiators require all of the following safety procedures except:
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a. proper training. nn
b. that the user have a degree in radiology.
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c. equipment leak detection. nn nn
d. personal protective equipment. nn nn
ANS: B n n
Blood bank and transfusion service technologists require training but not a degree to use a blood
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irradiator.
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DIF: Level 2 nn REF: n n p. 16 nn
7. Which of the following is true regarding good manufacturing practices (GMPs)?
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a. GMPs are legal requirements established by the Food and Drug Administration.
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b. GMPs are optional guidelines written by the AABB. nn nn nn nn nn nn nn
c. GMPs are required only by pharmaceutical companies. nn nn nn nn nn nn
d. GMPs are part of the quality control requirements for blood products.
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ANS: A n n
Good manufacturing practices are requirements established by the Food and Drug Administration.
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DIF: Level 1 nn REF: n n p. 5 nn
8. Which of the following is an example of an unacceptable record-keeping procedure?
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a. Using dittos in columns to save time nn nn nn nn nn nn
b. Recording the date and initials next to a correction nn nn nn nn nn nn nn nn
c. Not deleting the original entry when making a correction
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d. Always using permanent ink on all records nn nn nn nn nn nn
ANS: A n n
All records must be clearly written. Dittos are unacceptable.
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9. A technologist in training noticed that the person training her had not recorded the results of a
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test. To be helpful, she carefully recorded the results she saw at a later time, using the
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technologist’s initials. Is this an acceptable procedure?
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a. Yes; all results must be recorded regardless of who did the test.
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b. No; she should have brought the error to the technologist’s attention.
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c. Yes; because she used the other technologist’s initials.
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d. Yes; as long as she records the result in pencil.
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ANS: B n n
This is an example of poor record keeping; results must be recorded when the test is performed
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and by the person doing the test.
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10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be nn nn nn nn nn nn nn nn nn nn nn nn nn
noticed if:
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a. preventive maintenance has not been performed on the cell washer. nn nn nn nn nn nn nn nn nn
b. the technologist performing the test was never trained.
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c. the reagents used were improperly stored.
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d. All of the above nn nn nn
ANS: D n n
Training, equipment maintenance, and reagent quality can affect quality control.
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DIF: Level 2 nn REF: n n p. 5 nn
11. All of the following are true regarding competency testing except:
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a. it must be performed following training.
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b. it must be performed on an annual basis.
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c. it is required only if the technologist has no experience.
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d. retraining is required if there is a failure in competency testing. nn nn nn nn nn nn nn nn nn nn
ANS: C n n
All employees must have competency testing following training and annually thereafter. If there
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is a failure in competency testing, retraining is required.
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DIF: Level 2 nn REF: n n p. 10 nn
12. Which of the following organizations are involved in the regulation of blood banks?
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a. The Joint Commission nn nn
b. AABB
c. College of American Pathologists nn nn nn
d. Food and Drug Administration nn nn nn
ANS: D n n
The Food and Drug Administration regulates blood banks, whereas the other organizations are
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involved in accreditation.
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