BASIC &APPLIED CONCEPTS OFBLOOD BANKING AND TRANSFUSION
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PRACTICES 5TH EDITION
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Paula R. Howard
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,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood
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Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
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MULTIPLE CHOICE a
1. Biosafety levels determine: a a
a. on what floor certain infectious disease testing can be performed.
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b. the degree of risk for certain areas of a health care facility to exposure to
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infectious diseases.
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c. the amount of ventilation required in a transfusion service.
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d. how many biohazardous waste containers a laboratory must have.
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ANS: B a
OSHA defines biosafety levels based on potential exposure to infectious material.
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DIF: Level 1 a
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had too
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a returned by the laboratory’s laundry service. Is this practice acceptable?
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a. Yes, if she uses 10% bleach a a a a a
b. Yes, if she clears it with her supervisor a a a a a a a
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 a
ANS: D a
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to bring
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DIF: Level 2 a
3. Personal protective equipment includes: a a a
a. safety glasses. a
b. splash barriers. a
c. masks.
d. All of the above a a a
ANS: D a
Safety glasses, splash barriers, and masks are types of personal protective devices.
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DIF: Level 1 a
4. At what point in the employment process should safety training take place?
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a. During orientation and training a a a
b. Following lab training when employees are more familiar with their a a a a a a a a a
responsibilities
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c. Following the employees’ first evaluation a a a a
d. Before independent work is permitted and annually thereafter a a a a a a a
ANS: D a
The Occupation Safety and Health Administration requires safety training before independent work is perm
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DIF: Level 1 a
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. a a a a a
b. limits of protective clothing and equipment. a a a a a
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 a
, 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. a a a a a a a
c. GMPs are required only by pharmaceutical companies. a a a a a a
d. GMPs are part of the quality control requirements for blood products.
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ANS: A a
Good manufacturing practices are requirements established by the Food and Drug Administration.
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DIF: Level 1 a
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 a a a a a a
b. Recording the date and initials next to a correction a a a a a a a a
c. Not deleting the original entry when making a correction
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d. Always using permanent ink on all records a a a a a a
ANS: A a
All records must be clearly written. Dittos are unacceptable.
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DIF: Level 1 a
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be help
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recorded the results she saw at a later time, using the 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 a
This is an example of poor record keeping; results must be recorded when the test is performed and by the pe
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DIF: Level 3 a
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
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a. preventive maintenance has not been performed on the cell washer. a a a a a a a a a
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 a a a
ANS: D a
Training, equipment maintenance, and reagent quality can affect quality control.
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DIF: Level 2 a
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. a a a a a a a a a a
ANS: C a
All employees must have competency testing following training and annually thereafter. If there is a failure i
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required.
a
DIF: Level 2 a
12. Which of the following organizations are involved in the regulation of blood banks?
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a. The Joint Commission a a
b. AABB
c. College of American Pathologists a a a
, 14. The standard operating procedure is a document that:
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a. helps achieve consistency of results. a a a a
b. may be substituted with package inserts.
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c. is necessary only for training new employees.
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d. must be very detailed to be accurate. a a a a a a
ANS: A a
Standard operating procedures are written procedures that help achieve consistency and should be clear and
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DIF: Level 2 a
15. Employee training takes place: a a a
a. after hiring and following implementation of new procedures.
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b. following competency assessment. a a
c. only for new inexperienced employees. a a a a
d. as procedures are validated. a a a
ANS: A a
Training occurs with all new employees regardless of their experience and following implementation of new
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DIF: Level 1 a
16. Plans that provide the framework for establishing quality assurance in an organization are:
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a. current good manufacturing practices. a a a
b. standard operating procedures. a a
c. change control plan. a a
d. continuous quality improvement plan. a a a
ANS: D a
The total quality management or continuous quality improvement plan are part of the quality assurance prog
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DIF: Level 1 a
17. A facility does not validate a refrigerator before use. What is a potential outcome?
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a. The facility is in violation of current good manufacturing practices and could be
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cited by the Food and Drug Administration.
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b. The facility is in compliance if the equipment functions properly.
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c. The facility is in compliance if the blood products stored in it are not transfused.
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d. The facility is in violation of AABB and may no longer be members.
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ANS: A a
Validation of equipment is a current good manufacturing practice, which is a legal requirement established b
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Administration.
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DIF: Level 2 a
MULTIPLE RESPONSE a
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the blood b
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particular day had expired. What is the appropriate course of action? (Select all that apply.)
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a. Initiate a root cause analysis and quarantine the blood collected in the expired
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bags. a
b. Notify the FDA since the expired bags were distributed. a a a a a a a a
c. Change the expiration date on the bags to avoid legal issues. a a a a a a a a a a
d. Fire the donor room supervisor, and discard the blood collected in the expired
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bags. a
ANS: A, B a a
A root cause analysis will determine the factors that contributed to the error and result in a plan to prevent fur
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DIF: Level 3 a