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