TESTBANK J
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION
J J J J J J J J
PRACTICES 5TH EDITION
J J J
Paula R. Howard
J J
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Bloo
J J J J J J J J J J J J J J J
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
J J J J J J J J J J J J
MULTIPLE CHOICE J
1. Biosafety levels determine: J J
a. on what floor certain infectious disease testing can be performed.
J J J J J J J J J
b. the degree of risk for certain areas of a health care facility to exposure to
J J J J J J J J J J J J J J
infectious diseases.
J J
c. the amount of ventilation required in a transfusion service.
J J J J J J J J
d. how many biohazardous waste containers a laboratory must have.
J J J J J J J J
ANS: B J
OSHA defines biosafety levels based on potential exposure to infectious material.
J J J J J J J J J J
DIF: Level1 J
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had to
J J J J J J J J J J J J J J J J J J
Jreturned by the laboratory’s laundry service. Is this practice acceptable?
J J J J J J J J J
a. Yes, if she uses 10% bleach J J J J J
b. Yes, if she clears it with her supervisor J J J J J J J
c. Yes, as long as she removes the coat and does not wear it home
J J J J J J J J J J J J J
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
J J J J J J J J J J J J J J
removed J
ANS: D J
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to bring
J J J J J J J J J J J J J J J J J J
DIF: Level2 J
3. Personal protective equipment includes: J J J
a. safety glasses. J
b. splash barriers. J
c. masks.
d. All of the above J J J
ANS: D J
Safety glasses, splash barriers, and masks are types of personal protective devices.
J J J J J J J J J J J
DIF: Level1 J
4. At what point in the employment process should safety training take place?
J J J J J J J J J J J
a. During orientation and training J J J
b. Following lab training when employees are more familiar with their J J J J J J J J J
responsibilities
J
c. Following the employees’ first evaluation J J J J
d. Before independent work is permitted and annually thereafter
J J J J J J J
ANS: D J
The Occupation Safety and Health Administration requires safety training before independent work is perm
J J J J J J J J J J J J J
DIF: Level1 J
5. In safety training, employees must become familiar with all of the following except:
J J J J J J J J J J J J
a. tasks that have an infectious risk. J J J J J
b. limits of protective clothing and equipment. J J J J J
c. the appropriate action to take if exposure occurs.
J J J J J J J
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
J J J J J J J J J J
ANS: D J
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
J J J J J J J J J J
a. GMPs are legal requirements established by the Food and Drug Administration.
J J J J J J J J J J
b. GMPs are optional guidelines written by the AABB. J J J J J J J
c. GMPs are required only by pharmaceutical companies.J J J J J J
d. GMPs are part of the quality control requirements for blood products.
J J J J J J J J J J
ANS: A J
Good manufacturing practices are requirements established by the Food and Drug Administration.
J J J J J J J J J J J
DIF: Level1 J
8. Which of the following is an example of an unacceptable record-keeping procedure?
J J J J J J J J J J J
a. Using dittos in columns to save time J J J J J J
b. Recording the date and initials next to a correction J J J J J J J J
c. Not deleting the original entry when making a correction
J J J J J J J J
d. Always using permanent ink on all records J J J J J J
ANS: A J
All records must be clearly written. Dittos are unacceptable.
J J J J J J J J
DIF: Level1 J
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be hel
J J J J J J J J J J J J J J J J J J J J
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedure?
J J J J J J J J J J J J J J J J J J
a. Yes; all results must be recorded regardless of who did the test.
J J J J J J J J J J J
b. No; she should have brought the error to the technologist’s attention.
J J J J J J J J J J
c. Yes; because she used the other technologist’s initials.
J J J J J J J
d. Yes; as long as she records the result in pencil.
J J J J J J J J J
ANS: B J
This is an example of poor record keeping; results must be recorded when the test is performed and by the pe
J J J J J J J J J J J J J J J J J J J J
DIF: Level3 J
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
J J J J J J J J J J J J J J J
a. preventive maintenance has not been performed on the cell washer. J J J J J J J J J
b. the technologist performing the test was never trained.
J J J J J J J
c. the reagents used were improperly stored.
J J J J J
d. All of the above J J J
ANS: D J
Training, equipment maintenance, and reagent quality can affect quality control.
J J J J J J J J J
DIF: Level2 J
11. All of the following are true regarding competency testing except:
J J J J J J J J J
a. it must be performed following training.
J J J J J
b. it must be performed on an annual basis.
J J J J J J J
c. it is required only if the technologist has no experience.
J J J J J J J J J
d. retraining is required if there is a failure in competency testing. J J J J J J J J J J
ANS: C J
All employees must have competency testing following training and annually thereafter. If there is a failure
J J J J J J J J J J J J J J J J
required.
J
DIF: Level2 J
12. Which of the following organizations are involved in the regulation of blood banks?
J J J J J J J J J J J J
a. The Joint Commission J J
b. AABB
c. College of American Pathologists J J J
, 14. The standard operating procedure is a document that:
J J J J J J J
a. helps achieve consistency of results. J J J J
b. may be substituted with package inserts. J J J J J
c. is necessary only for training new employees.
J J J J J J
d. must be very detailed to be accurate. J J J J J J
ANS: A J
Standard operating procedures are written procedures that help achieve consistency and should be clear and
J J J J J J J J J J J J J J
DIF: Level2 J
15. Employee training takes place: J J J
a. after hiring and following implementation of new procedures.
J J J J J J J
b. following competency assessment. J J
c. only for new inexperienced employees. J J J J
d. as procedures are validated. J J J
ANS: A J
Training occurs with all new employees regardless of their experience and following implementation of new
J J J J J J J J J J J J J J
DIF: Level1 J
16. Plans that provide the framework for establishing quality assurance in an organization are:
J J J J J J J J J J J J
a. current good manufacturing practices. J J J
b. standard operating procedures. J J
c. change control plan. J J
d. continuous quality improvement plan. J J J
ANS: D J
The total quality management or continuous quality improvement plan are part of the quality assurance prog
J J J J J J J J J J J J J J J
DIF: Level1 J
17. A facility does not validate a refrigerator before use. What is a potential outcome?
J J J J J J J J J J J J J
a. The facility is in violation of current good manufacturing practices and could be cited
J J J J J J J J J J J J J
by the Food and Drug Administration.
J J J J J J
b. The facility is in compliance if the equipment functions properly.
J J J J J J J J J
c. The facility is in compliance if the blood products stored in it are not transfused.
J J J J J J J J J J J J J J
d. The facility is in violation of AABB and may no longer be members.
J J J J J J J J J J J J
ANS: A J
Validation of equipment is a current good manufacturing practice, which is a legal requirement established b
J J J J J J J J J J J J J J J
Administration.
J
DIF: Level2 J
MULTIPLE RESPONSE J
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the blood
J J J J J J J J J J J J J J J J J
particular day had expired. What is the appropriate course of action? (Select all that apply.)
J J J J J J J J J J J J J J J
a. Initiate a root cause analysis and quarantine the blood collected in the expired
J J J J J J J J J J J J
bags. J
b. Notify the FDA since the expired bags were distributed. J J J J J J J J
c. Change the expiration date on the bags to avoid legal issues. J J J J J J J J J J
d. Fire the donor room supervisor, and discard the blood collected in the expired
J J J J J J J J J J J J
bags. J
ANS: A, B J J
A root cause analysis will determine the factors that contributed to the error and result in a plan to prevent fu
J J J J J J J J J J J J J J J J J J J J
DIF: Level3 J
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION
J J J J J J J J
PRACTICES 5TH EDITION
J J J
Paula R. Howard
J J
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Bloo
J J J J J J J J J J J J J J J
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
J J J J J J J J J J J J
MULTIPLE CHOICE J
1. Biosafety levels determine: J J
a. on what floor certain infectious disease testing can be performed.
J J J J J J J J J
b. the degree of risk for certain areas of a health care facility to exposure to
J J J J J J J J J J J J J J
infectious diseases.
J J
c. the amount of ventilation required in a transfusion service.
J J J J J J J J
d. how many biohazardous waste containers a laboratory must have.
J J J J J J J J
ANS: B J
OSHA defines biosafety levels based on potential exposure to infectious material.
J J J J J J J J J J
DIF: Level1 J
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had to
J J J J J J J J J J J J J J J J J J
Jreturned by the laboratory’s laundry service. Is this practice acceptable?
J J J J J J J J J
a. Yes, if she uses 10% bleach J J J J J
b. Yes, if she clears it with her supervisor J J J J J J J
c. Yes, as long as she removes the coat and does not wear it home
J J J J J J J J J J J J J
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
J J J J J J J J J J J J J J
removed J
ANS: D J
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to bring
J J J J J J J J J J J J J J J J J J
DIF: Level2 J
3. Personal protective equipment includes: J J J
a. safety glasses. J
b. splash barriers. J
c. masks.
d. All of the above J J J
ANS: D J
Safety glasses, splash barriers, and masks are types of personal protective devices.
J J J J J J J J J J J
DIF: Level1 J
4. At what point in the employment process should safety training take place?
J J J J J J J J J J J
a. During orientation and training J J J
b. Following lab training when employees are more familiar with their J J J J J J J J J
responsibilities
J
c. Following the employees’ first evaluation J J J J
d. Before independent work is permitted and annually thereafter
J J J J J J J
ANS: D J
The Occupation Safety and Health Administration requires safety training before independent work is perm
J J J J J J J J J J J J J
DIF: Level1 J
5. In safety training, employees must become familiar with all of the following except:
J J J J J J J J J J J J
a. tasks that have an infectious risk. J J J J J
b. limits of protective clothing and equipment. J J J J J
c. the appropriate action to take if exposure occurs.
J J J J J J J
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
J J J J J J J J J J
ANS: D J
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
J J J J J J J J J J
a. GMPs are legal requirements established by the Food and Drug Administration.
J J J J J J J J J J
b. GMPs are optional guidelines written by the AABB. J J J J J J J
c. GMPs are required only by pharmaceutical companies.J J J J J J
d. GMPs are part of the quality control requirements for blood products.
J J J J J J J J J J
ANS: A J
Good manufacturing practices are requirements established by the Food and Drug Administration.
J J J J J J J J J J J
DIF: Level1 J
8. Which of the following is an example of an unacceptable record-keeping procedure?
J J J J J J J J J J J
a. Using dittos in columns to save time J J J J J J
b. Recording the date and initials next to a correction J J J J J J J J
c. Not deleting the original entry when making a correction
J J J J J J J J
d. Always using permanent ink on all records J J J J J J
ANS: A J
All records must be clearly written. Dittos are unacceptable.
J J J J J J J J
DIF: Level1 J
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be hel
J J J J J J J J J J J J J J J J J J J J
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedure?
J J J J J J J J J J J J J J J J J J
a. Yes; all results must be recorded regardless of who did the test.
J J J J J J J J J J J
b. No; she should have brought the error to the technologist’s attention.
J J J J J J J J J J
c. Yes; because she used the other technologist’s initials.
J J J J J J J
d. Yes; as long as she records the result in pencil.
J J J J J J J J J
ANS: B J
This is an example of poor record keeping; results must be recorded when the test is performed and by the pe
J J J J J J J J J J J J J J J J J J J J
DIF: Level3 J
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
J J J J J J J J J J J J J J J
a. preventive maintenance has not been performed on the cell washer. J J J J J J J J J
b. the technologist performing the test was never trained.
J J J J J J J
c. the reagents used were improperly stored.
J J J J J
d. All of the above J J J
ANS: D J
Training, equipment maintenance, and reagent quality can affect quality control.
J J J J J J J J J
DIF: Level2 J
11. All of the following are true regarding competency testing except:
J J J J J J J J J
a. it must be performed following training.
J J J J J
b. it must be performed on an annual basis.
J J J J J J J
c. it is required only if the technologist has no experience.
J J J J J J J J J
d. retraining is required if there is a failure in competency testing. J J J J J J J J J J
ANS: C J
All employees must have competency testing following training and annually thereafter. If there is a failure
J J J J J J J J J J J J J J J J
required.
J
DIF: Level2 J
12. Which of the following organizations are involved in the regulation of blood banks?
J J J J J J J J J J J J
a. The Joint Commission J J
b. AABB
c. College of American Pathologists J J J
, 14. The standard operating procedure is a document that:
J J J J J J J
a. helps achieve consistency of results. J J J J
b. may be substituted with package inserts. J J J J J
c. is necessary only for training new employees.
J J J J J J
d. must be very detailed to be accurate. J J J J J J
ANS: A J
Standard operating procedures are written procedures that help achieve consistency and should be clear and
J J J J J J J J J J J J J J
DIF: Level2 J
15. Employee training takes place: J J J
a. after hiring and following implementation of new procedures.
J J J J J J J
b. following competency assessment. J J
c. only for new inexperienced employees. J J J J
d. as procedures are validated. J J J
ANS: A J
Training occurs with all new employees regardless of their experience and following implementation of new
J J J J J J J J J J J J J J
DIF: Level1 J
16. Plans that provide the framework for establishing quality assurance in an organization are:
J J J J J J J J J J J J
a. current good manufacturing practices. J J J
b. standard operating procedures. J J
c. change control plan. J J
d. continuous quality improvement plan. J J J
ANS: D J
The total quality management or continuous quality improvement plan are part of the quality assurance prog
J J J J J J J J J J J J J J J
DIF: Level1 J
17. A facility does not validate a refrigerator before use. What is a potential outcome?
J J J J J J J J J J J J J
a. The facility is in violation of current good manufacturing practices and could be cited
J J J J J J J J J J J J J
by the Food and Drug Administration.
J J J J J J
b. The facility is in compliance if the equipment functions properly.
J J J J J J J J J
c. The facility is in compliance if the blood products stored in it are not transfused.
J J J J J J J J J J J J J J
d. The facility is in violation of AABB and may no longer be members.
J J J J J J J J J J J J
ANS: A J
Validation of equipment is a current good manufacturing practice, which is a legal requirement established b
J J J J J J J J J J J J J J J
Administration.
J
DIF: Level2 J
MULTIPLE RESPONSE J
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the blood
J J J J J J J J J J J J J J J J J
particular day had expired. What is the appropriate course of action? (Select all that apply.)
J J J J J J J J J J J J J J J
a. Initiate a root cause analysis and quarantine the blood collected in the expired
J J J J J J J J J J J J
bags. J
b. Notify the FDA since the expired bags were distributed. J J J J J J J J
c. Change the expiration date on the bags to avoid legal issues. J J J J J J J J J J
d. Fire the donor room supervisor, and discard the blood collected in the expired
J J J J J J J J J J J J
bags. J
ANS: A, B J J
A root cause analysis will determine the factors that contributed to the error and result in a plan to prevent fu
J J J J J J J J J J J J J J J J J J J J
DIF: Level3 J
