BASIC &APPLIED CONCEPTS OFBLOOD BANKINGAND 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 Bloo
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Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
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MULTIPLECHOICE Il̀
1. Biosafety levels determine: Il` Il`
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: I l ` B
OSHA defines biosafety levels based on potential exposure to infectious material.
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DIF: Level 1 Il`
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had
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Il` was returned by the laboratory’s laundry service. Is this practice acceptable?
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a. Yes, if she uses 10% bleach Il` Il` Il` Il` Il`
b. Yes, if she clears it with her supervisor Il` Il` Il` Il` Il` Il` Il`
c. Yes, as long as she removes the coat and does not wear it home Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
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removed Il`
ANS: I l ` D
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to bri
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DIF: Level 2 Il`
3. Personal protective equipment includes: Il` Il` Il`
a. safety glasses. Il`
b. splash barriers. Il`
c. masks.
d. All of the above Il` Il` Il`
ANS: I l ` D
Safety glasses, splash barriers, and masks are types of personal protective devices.
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DIF: Level 1 Il`
4. At what point in the employment process should safety training take place?
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a. During orientation and training Il` Il` Il`
b. Following lab training when employees are more familiar with their Il` Il` Il` Il` Il` Il` Il` Il` Il`
responsibilities
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c. Following the employees’ first evaluation Il` Il` Il` Il`
d. Before independent work is permitted and annually thereafter Il` Il` Il` Il` Il` Il` Il`
ANS: I l ` D
The Occupation Safety and Health Administration requires safety training before independent work is per
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DIF: Level 1 Il`
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. Il` Il` Il` Il` Il`
b. limits of protective clothing and equipment. Il` Il` Il` Il` Il`
c. the appropriate action to take if exposure occurs. Il` Il` Il` Il` Il` Il` Il`
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
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ANS: I l ` D
, 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. Il` Il` Il` Il` Il` Il` Il`
c. GMPs are required only by pharmaceutical companies. Il` Il` Il` Il` Il` Il`
d. GMPs are part of the quality control requirements for blood products. Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`
ANS: I l ` A
Good manufacturing practices are requirements established by the Food and Drug Administration.
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DIF: Level 1 Il`
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 Il` Il` Il` Il` Il` Il`
b. Recording the date and initials next to a correction Il` Il` Il` Il` Il` Il` Il` Il`
c. Not deleting the original entry when making a correction
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d. Always using permanent ink on all records Il` Il` Il` Il` Il` Il`
ANS: I l ` A
All records must be clearly written. Dittos are unacceptable.
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DIF: Level 1 Il`
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be h
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recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedu
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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. Il` Il` Il` Il` Il` Il` Il` Il` Il`
ANS: I l ` B
This is an example of poor record keeping; results must be recorded when the test is performed and by th
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DIF: Level 3 Il`
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if: Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`
a. preventive maintenance has not been performed on the cell washer. Il` Il` Il` Il` Il` Il` Il` Il` Il`
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 Il` Il` Il`
ANS: I l ` D
Training, equipment maintenance, and reagent quality can affect quality control.
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DIF: Level 2 Il`
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. Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`
ANS: I l ` C
All employees must have competency testing following training and annually thereafter. If there is a failur
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retraining is required.
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DIF: Level 2 Il`
12. Which of the following organizations are involved in the regulation of blood banks?
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a. The Joint Commission Il` Il`
b. AABB
c. College of American Pathologists Il` Il` Il`
, 14. The standard operating procedure is a document that:
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a. helps achieve consistency of results. Il` Il` Il` Il`
b. may be substituted with package inserts. Il` Il` Il` Il` Il`
c. is necessary only for training new employees.
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d. must be very detailed to be accurate. Il` Il` Il` Il` Il` Il`
ANS: I l ` A
Standard operating procedures are written procedures that help achieve consistency and should be clear a
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DIF: Level 2 Il`
15. Employee training takes place: Il` Il` Il`
a. after hiring and following implementation of new procedures. Il` Il` Il` Il` Il` Il` Il`
b. following competency assessment. Il` Il`
c. only for new inexperienced employees. Il` Il` Il` Il`
d. as procedures are validated. Il` Il` Il`
ANS: I l ` A
Training occurs with all new employees regardless of their experience and following implementation of
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DIF: Level 1 Il`
16. Plans that provide the framework for establishing quality assurance in an organization are:
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a. current good manufacturing practices. Il` Il` Il`
b. standard operating procedures. Il` Il`
c. change control plan. Il` Il`
d. continuous quality improvement plan. Il` Il` Il`
ANS: I l ` D
The total quality management or continuous quality improvement plan are part of the quality assurance p
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DIF: Level 1 Il`
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: I l ` A
Validation of equipment is a current good manufacturing practice, which is a legal requirement establishe
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Administration.
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DIF: Level 2 Il`
MULTIPLERESPONSE Il̀
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the bloo
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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 Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`
bags. Il`
b. Notify the FDA since the expired bags were distributed. Il` Il` Il` Il` Il` Il` Il` Il`
c. Change the expiration date on the bags to avoid legal issues. Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`
d. Fire the donor room supervisor, and discard the blood collected in the expired
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bags. Il`
ANS: I l ` A, B Il`
A root cause analysis will determine the factors that contributed to the error and result in a plan to preven
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DIF: Level 3 Il`