,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues
b b b b b b b b b b b b
in the Blood Bank
b b b b
Howard: b
MULTIPLE CHOICE b
1. Which of the following agencies administers the Clinical Laboratory
b b b b b b b b
bImprovement Amendments? b
a. AABB
b. Centers for Medicare and Medicaid Services b b b b b
c. OSHA
d. Food and Drug Administration b b b
ANS: b B
The Centers for Medicare and Medicaid Services administers CLIA, Medicare, Medicaid, and
b b b b b b b b b b b
HIPAA.
b
DIF: Level 1 b REF: b b p. 3 b
2. A laboratory technologist decided she would like to bring her lab coat home for
b b b b b b b b b b b b b
blaundering because it had too many wrinkles when returned by the laboratory’s laundry
b b b b b b b b b b b b
bservice. Is this practice acceptable?
b b b b
a. Yes, if she uses 10% bleach b b b b b
b. Yes, if she clears it with her supervisor
b b b b b b b
c. Yes, as long as she removes the coat and does not wear it home
b b b b b b b b b b b b b
d. No, because the laboratory is a biosafety level 2, and lab coats may not
b b b b b b b b b b b b b
be removed
b b
ANS: b D
Methods of transporting the lab coat and the risk of contamination do not permit health care
b b b b b b b b b b b b b b b
workers to bring lab coats home for cleaning.
b b b b b b b b
DIF: Level 2 b REF: b b p. 14 b
3. Personal protective equipment includes: b b b
a. safety glasses. b
b. splash barriers. b
c. masks.
d. All of the above b b b
ANS: b D
Safety glasses, splash barriers, and masks are types of personal protective devices.
b b b b b b b b b b b
DIF: Level 1 b REF: b b p. 14 b
4. At what point in the employment process should safety training take place?
b b b b b b b b b b b
a. During orientation and training b b b
b. Following lab training when employees are more familiar with b b b b b b b b
their responsibilities
b b
, c. Following the employees’ first evaluation b b b b
d. Before independent work is permitted and annually thereafter
b b b b b b b
ANS: b D
The Occupation Safety and Health Administration requires safety training before independent
b b b b b b b b b b
work is permitted and annually thereafter.
b b b b b b
DIF: Level 1 b REF: b b p. 17 b
5. In safety training, employees must become familiar with all of the following except:
b b b b b b b b b b b b
a. tasks that have an infectious risk.
b b b b b
b. limits of protective clothing and equipment.
b b b b b
c. the appropriate action to take if exposure occurs.
b b b b b b b
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
b b b b b b b b b b
ANS: b D
The Occupational Safety and Health Administration requirements include all of those listed
b b b b b b b b b b b
except cardiopulmonary resuscitation.
b b b
DIF: Level 1 b REF: b b p. 13 b
6. Blood irradiators require all of the following safety procedures except:
b b b b b b b b b
a. proper training. b
b. that the user have a degree in radiology.
b b b b b b b
c. equipment leak detection. b b
d. personal protective equipment. b b
ANS: b B
Blood bank and transfusion service technologists require training but not a degree to use a
b b b b b b b b b b b b b b
blood irradiator.
b b
DIF: Level 2 b REF: b b p. 16 b
7. Which of the following is true regarding good manufacturing practices (GMPs)?
b b b b b b b b b b
a. GMPs are legal requirements established by the Food and Drug Administration.
b b b b b b b b b b
b. GMPs are optional guidelines written by the AABB.
b b b b b b b
c. GMPs are required only by pharmaceutical companies.
b b b b b b
d. GMPs are part of the quality control requirements for blood products.
b b b b b b b b b b
ANS: b A
Good manufacturing practices are requirements established by the Food and Drug
b b b b b b b b b b
Administration.
b
DIF: Level 1 b REF: b b p. 5 b
8. Which of the following is an example of an unacceptable record-keeping procedure?
b b b b b b b b b b b
a. Using dittos in columns to save time b b b b b b
b. Recording the date and initials next to a correction b b b b b b b b
c. Not deleting the original entry when making a correction
b b b b b b b b
d. Always using permanent ink on all records b b b b b b
ANS: b A
All records must be clearly written. Dittos are unacceptable.
b b b b b b b b
, DIF: Level 1 b REF: b b p. 7 b
9. A technologist in training noticed that the person training her had not recorded the results of
b b b b b b b b b b b b b b b
ba test. To be helpful, she carefully recorded the results she saw at a later time, using the
b b b b b b b b b b b b b b b b b
btechnologist’s initials. Is this an acceptable procedure? b b b b b b
a. Yes; all results must be recorded regardless of who did the test.
b b b b b b b b b b b
b. No; she should have brought the error to the technologist’s attention.
b b b b b b b b b b
c. Yes; because she used the other technologist’s initials.
b b b b b b b
d. Yes; as long as she records the result in pencil.
b b b b b b b b b
ANS: b B
This is an example of poor record keeping; results must be recorded when the test is
b b b b b b b b b b b b b b b
performed and by the person doing the test.
b b b b b b b b
DIF: Level 3 b REF: b b p. 8 b
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may
b b b b b b b b b b b b
bbe noticed if:
b b
a. preventive maintenance has not been performed on the cell washer. b b b b b b b b b
b. the technologist performing the test was never trained.
b b b b b b b
c. the reagents used were improperly stored.
b b b b b
d. All of the above b b b
ANS: b D
Training, equipment maintenance, and reagent quality can affect quality control.
b b b b b b b b b
DIF: Level 2 b REF: b b p. 5 b
11. All of the following are true regarding competency testing except:
b b b b b b b b b
a. it must be performed following training.
b b b b b
b. it must be performed on an annual basis.
b b b b b b b
c. it is required only if the technologist has no experience.
b b b b b b b b b
d. retraining is required if there is a failure in competency testing.
b b b b b b b b b b
ANS: b C
All employees must have competency testing following training and annually thereafter. If
b b b b b b b b b b b
there is a failure in competency testing, retraining is required.
b b b b b b b b b b
DIF: Level 2 b REF: b b p. 10 b
12. Which of the following organizations are involved in the regulation of blood banks?
b b b b b b b b b b b b
a. The Joint Commission b b
b. AABB
c. College of American Pathologists b b b
d. Food and Drug Administration b b b
ANS: b D
The Food and Drug Administration regulates blood banks, whereas the other organizations
b b b b b b b b b b b
are involved in accreditation.
b b b b
DIF: Level 1 b REF: b b p. 2 b
b b b b b b b b b b b b
in the Blood Bank
b b b b
Howard: b
MULTIPLE CHOICE b
1. Which of the following agencies administers the Clinical Laboratory
b b b b b b b b
bImprovement Amendments? b
a. AABB
b. Centers for Medicare and Medicaid Services b b b b b
c. OSHA
d. Food and Drug Administration b b b
ANS: b B
The Centers for Medicare and Medicaid Services administers CLIA, Medicare, Medicaid, and
b b b b b b b b b b b
HIPAA.
b
DIF: Level 1 b REF: b b p. 3 b
2. A laboratory technologist decided she would like to bring her lab coat home for
b b b b b b b b b b b b b
blaundering because it had too many wrinkles when returned by the laboratory’s laundry
b b b b b b b b b b b b
bservice. Is this practice acceptable?
b b b b
a. Yes, if she uses 10% bleach b b b b b
b. Yes, if she clears it with her supervisor
b b b b b b b
c. Yes, as long as she removes the coat and does not wear it home
b b b b b b b b b b b b b
d. No, because the laboratory is a biosafety level 2, and lab coats may not
b b b b b b b b b b b b b
be removed
b b
ANS: b D
Methods of transporting the lab coat and the risk of contamination do not permit health care
b b b b b b b b b b b b b b b
workers to bring lab coats home for cleaning.
b b b b b b b b
DIF: Level 2 b REF: b b p. 14 b
3. Personal protective equipment includes: b b b
a. safety glasses. b
b. splash barriers. b
c. masks.
d. All of the above b b b
ANS: b D
Safety glasses, splash barriers, and masks are types of personal protective devices.
b b b b b b b b b b b
DIF: Level 1 b REF: b b p. 14 b
4. At what point in the employment process should safety training take place?
b b b b b b b b b b b
a. During orientation and training b b b
b. Following lab training when employees are more familiar with b b b b b b b b
their responsibilities
b b
, c. Following the employees’ first evaluation b b b b
d. Before independent work is permitted and annually thereafter
b b b b b b b
ANS: b D
The Occupation Safety and Health Administration requires safety training before independent
b b b b b b b b b b
work is permitted and annually thereafter.
b b b b b b
DIF: Level 1 b REF: b b p. 17 b
5. In safety training, employees must become familiar with all of the following except:
b b b b b b b b b b b b
a. tasks that have an infectious risk.
b b b b b
b. limits of protective clothing and equipment.
b b b b b
c. the appropriate action to take if exposure occurs.
b b b b b b b
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
b b b b b b b b b b
ANS: b D
The Occupational Safety and Health Administration requirements include all of those listed
b b b b b b b b b b b
except cardiopulmonary resuscitation.
b b b
DIF: Level 1 b REF: b b p. 13 b
6. Blood irradiators require all of the following safety procedures except:
b b b b b b b b b
a. proper training. b
b. that the user have a degree in radiology.
b b b b b b b
c. equipment leak detection. b b
d. personal protective equipment. b b
ANS: b B
Blood bank and transfusion service technologists require training but not a degree to use a
b b b b b b b b b b b b b b
blood irradiator.
b b
DIF: Level 2 b REF: b b p. 16 b
7. Which of the following is true regarding good manufacturing practices (GMPs)?
b b b b b b b b b b
a. GMPs are legal requirements established by the Food and Drug Administration.
b b b b b b b b b b
b. GMPs are optional guidelines written by the AABB.
b b b b b b b
c. GMPs are required only by pharmaceutical companies.
b b b b b b
d. GMPs are part of the quality control requirements for blood products.
b b b b b b b b b b
ANS: b A
Good manufacturing practices are requirements established by the Food and Drug
b b b b b b b b b b
Administration.
b
DIF: Level 1 b REF: b b p. 5 b
8. Which of the following is an example of an unacceptable record-keeping procedure?
b b b b b b b b b b b
a. Using dittos in columns to save time b b b b b b
b. Recording the date and initials next to a correction b b b b b b b b
c. Not deleting the original entry when making a correction
b b b b b b b b
d. Always using permanent ink on all records b b b b b b
ANS: b A
All records must be clearly written. Dittos are unacceptable.
b b b b b b b b
, DIF: Level 1 b REF: b b p. 7 b
9. A technologist in training noticed that the person training her had not recorded the results of
b b b b b b b b b b b b b b b
ba test. To be helpful, she carefully recorded the results she saw at a later time, using the
b b b b b b b b b b b b b b b b b
btechnologist’s initials. Is this an acceptable procedure? b b b b b b
a. Yes; all results must be recorded regardless of who did the test.
b b b b b b b b b b b
b. No; she should have brought the error to the technologist’s attention.
b b b b b b b b b b
c. Yes; because she used the other technologist’s initials.
b b b b b b b
d. Yes; as long as she records the result in pencil.
b b b b b b b b b
ANS: b B
This is an example of poor record keeping; results must be recorded when the test is
b b b b b b b b b b b b b b b
performed and by the person doing the test.
b b b b b b b b
DIF: Level 3 b REF: b b p. 8 b
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may
b b b b b b b b b b b b
bbe noticed if:
b b
a. preventive maintenance has not been performed on the cell washer. b b b b b b b b b
b. the technologist performing the test was never trained.
b b b b b b b
c. the reagents used were improperly stored.
b b b b b
d. All of the above b b b
ANS: b D
Training, equipment maintenance, and reagent quality can affect quality control.
b b b b b b b b b
DIF: Level 2 b REF: b b p. 5 b
11. All of the following are true regarding competency testing except:
b b b b b b b b b
a. it must be performed following training.
b b b b b
b. it must be performed on an annual basis.
b b b b b b b
c. it is required only if the technologist has no experience.
b b b b b b b b b
d. retraining is required if there is a failure in competency testing.
b b b b b b b b b b
ANS: b C
All employees must have competency testing following training and annually thereafter. If
b b b b b b b b b b b
there is a failure in competency testing, retraining is required.
b b b b b b b b b b
DIF: Level 2 b REF: b b p. 10 b
12. Which of the following organizations are involved in the regulation of blood banks?
b b b b b b b b b b b b
a. The Joint Commission b b
b. AABB
c. College of American Pathologists b b b
d. Food and Drug Administration b b b
ANS: b D
The Food and Drug Administration regulates blood banks, whereas the other organizations
b b b b b b b b b b b
are involved in accreditation.
b b b b
DIF: Level 1 b REF: b b p. 2 b
