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