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 dstandard doperating dprocedure dis da ddocument dthat:
a. helps dachieve dconsistency dof dresults.
b. may dbe dsubstituted dwith dpackage dinserts.
c. is dnecessary donly dfor dtraining dnew demployees.
d. must dbe dvery ddetailed dto dbe daccurate.
ANS: d A
Standard doperating dprocedures dare dwritten dprocedures dthat dhelp dachieve dconsistency dand dshould d
DIF: Level d2
15. Employee dtraining dtakes dplace:
a. after dhiring dand dfollowing dimplementation dof dnew dprocedures.
b. following dcompetency dassessment.
c. only dfor dnew dinexperienced demployees.
d. as dprocedures dare dvalidated.
ANS: d A
Training doccurs dwith dall dnew demployees dregardless dof dtheir dexperience dand dfollowing dimplemen
DIF: Level d1
16. Plans dthat dprovide dthe dframework dfor destablishing dquality dassurance din dan dorganization dare:
a. current dgood dmanufacturing dpractices.
b. standard doperating dprocedures.
c. change dcontrol dplan.
d. continuous dquality dimprovement dplan.
ANS: d D
The dtotal dquality dmanagement dor dcontinuous dquality dimprovement dplan dare dpart dof dthe dquality da
dorganization.
DIF: Level d1
17. A dfacility ddoes dnot dvalidate da drefrigerator dbefore duse. dWhat dis da dpotential doutcome?
a. The dfacility dis din dviolation dof dcurrent dgood dmanufacturing dpractices dand
dcould dbe dcited dby dthe dFood dand dDrug dAdministration.
b. The dfacility dis din dcompliance dif dthe dequipment dfunctions dproperly.
c. The dfacility dis din dcompliance dif dthe dblood dproducts dstored din dit dare dnot dtransfused.
d. The dfacility dis din dviolation dof dAABB dand dmay dno dlonger dbe dmembers.
ANS: d A
Validation dof dequipment dis da dcurrent dgood dmanufacturing dpractice, dwhich dis da dlegal drequirement
dDrug dAdministration.
DIF: Level d2
MULTIPLE
dRESPONSE
1. In da droutine daudit dof da dfacilities dblood dcollection darea, dthe dquality dassurance ddepartment dfound d
dused don dthat dparticular dday dhad dexpired. dWhat dis dthe dappropriate dcourse dof daction? d(Select dall
a. Initiate da droot dcause danalysis dand dquarantine dthe dblood dcollected din dthe
dexpired dbags.
b. Notify dthe dFDA dsince dthe dexpired dbags dwere ddistributed.
c. Change dthe dexpiration ddate don dthe dbags dto davoid dlegal dissues.
d. Fire dthe ddonor droom dsupervisor, dand ddiscard dthe dblood dcollected din dthe
dexpired dbags.
ANS: d A, dB
A droot dcause danalysis dwill ddetermine dthe dfactors dthat dcontributed dto dthe derror dand dresult din da dp
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 dstandard doperating dprocedure dis da ddocument dthat:
a. helps dachieve dconsistency dof dresults.
b. may dbe dsubstituted dwith dpackage dinserts.
c. is dnecessary donly dfor dtraining dnew demployees.
d. must dbe dvery ddetailed dto dbe daccurate.
ANS: d A
Standard doperating dprocedures dare dwritten dprocedures dthat dhelp dachieve dconsistency dand dshould d
DIF: Level d2
15. Employee dtraining dtakes dplace:
a. after dhiring dand dfollowing dimplementation dof dnew dprocedures.
b. following dcompetency dassessment.
c. only dfor dnew dinexperienced demployees.
d. as dprocedures dare dvalidated.
ANS: d A
Training doccurs dwith dall dnew demployees dregardless dof dtheir dexperience dand dfollowing dimplemen
DIF: Level d1
16. Plans dthat dprovide dthe dframework dfor destablishing dquality dassurance din dan dorganization dare:
a. current dgood dmanufacturing dpractices.
b. standard doperating dprocedures.
c. change dcontrol dplan.
d. continuous dquality dimprovement dplan.
ANS: d D
The dtotal dquality dmanagement dor dcontinuous dquality dimprovement dplan dare dpart dof dthe dquality da
dorganization.
DIF: Level d1
17. A dfacility ddoes dnot dvalidate da drefrigerator dbefore duse. dWhat dis da dpotential doutcome?
a. The dfacility dis din dviolation dof dcurrent dgood dmanufacturing dpractices dand
dcould dbe dcited dby dthe dFood dand dDrug dAdministration.
b. The dfacility dis din dcompliance dif dthe dequipment dfunctions dproperly.
c. The dfacility dis din dcompliance dif dthe dblood dproducts dstored din dit dare dnot dtransfused.
d. The dfacility dis din dviolation dof dAABB dand dmay dno dlonger dbe dmembers.
ANS: d A
Validation dof dequipment dis da dcurrent dgood dmanufacturing dpractice, dwhich dis da dlegal drequirement
dDrug dAdministration.
DIF: Level d2
MULTIPLE
dRESPONSE
1. In da droutine daudit dof da dfacilities dblood dcollection darea, dthe dquality dassurance ddepartment dfound d
dused don dthat dparticular dday dhad dexpired. dWhat dis dthe dappropriate dcourse dof daction? d(Select dall
a. Initiate da droot dcause danalysis dand dquarantine dthe dblood dcollected din dthe
dexpired dbags.
b. Notify dthe dFDA dsince dthe dexpired dbags dwere ddistributed.
c. Change dthe dexpiration ddate don dthe dbags dto davoid dlegal dissues.
d. Fire dthe ddonor droom dsupervisor, dand ddiscard dthe dblood dcollected din dthe
dexpired dbags.
ANS: d A, dB
A droot dcause danalysis dwill ddetermine dthe dfactors dthat dcontributed dto dthe derror dand dresult din da dp
