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 sstandard soperating sprocedure sis sa sdocument sthat:
a. helps sachieve sconsistency sof sresults.
b. may sbe ssubstituted swith spackage sinserts.
c. is snecessary sonly sfor straining snew semployees.
d. must sbe svery sdetailed sto sbe saccurate.
ANS: s A
Standard soperating sprocedures sare swritten sprocedures sthat shelp sachieve sconsistency sand sshould sbe
DIF: Level s2
15. Employee straining stakes splace:
a. after shiring sand sfollowing simplementation sof snew sprocedures.
b. following scompetency sassessment.
c. only sfor snew sinexperienced semployees.
d. as sprocedures sare svalidated.
ANS: s A
Training soccurs swith sall snew semployees sregardless sof stheir sexperience sand sfollowing simplementa
DIF: Level s1
16. Plans sthat sprovide sthe sframework sfor sestablishing squality sassurance sin san sorganization sare:
a. current sgood smanufacturing spractices.
b. standard soperating sprocedures.
c. change scontrol splan.
d. continuous squality simprovement splan.
ANS: s D
The stotal squality smanagement sor scontinuous squality simprovement splan sare spart sof sthe squality sass
sorganization.
DIF: Level s1
17. A sfacility sdoes snot svalidate sa srefrigerator sbefore suse. sWhat sis sa spotential soutcome?
a. The sfacility sis sin sviolation sof scurrent sgood smanufacturing spractices sand
scould sbe scited sby sthe sFood sand sDrug sAdministration.
b. The sfacility sis sin scompliance sif sthe sequipment sfunctions sproperly.
c. The sfacility sis sin scompliance sif sthe sblood sproducts sstored sin sit sare snot stransfused.
d. The sfacility sis sin sviolation sof sAABB sand smay sno slonger sbe smembers.
ANS: s A
Validation sof sequipment sis sa scurrent sgood smanufacturing spractice, swhich sis sa slegal srequirement se
sDrug sAdministration.
DIF: Level s2
MULTIPLE sRESPONSE
1. In sa sroutine saudit sof sa sfacilities sblood scollection sarea, sthe squality sassurance sdepartment sfound stha
sused son sthat sparticular sday shad sexpired. sWhat sis sthe sappropriate scourse sof saction? s(Select sall stha
a. Initiate sa sroot scause sanalysis sand squarantine sthe sblood scollected sin sthe
sexpired sbags.
b. Notify sthe sFDA ssince sthe sexpired sbags swere sdistributed.
c. Change sthe sexpiration sdate son sthe sbags sto savoid slegal sissues.
d. Fire sthe sdonor sroom ssupervisor, sand sdiscard sthe sblood scollected sin sthe
sexpired sbags.
ANS: s A, sB
A sroot scause sanalysis swill sdetermine sthe sfactors sthat scontributed sto sthe serror sand sresult sin sa splan
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 sstandard soperating sprocedure sis sa sdocument sthat:
a. helps sachieve sconsistency sof sresults.
b. may sbe ssubstituted swith spackage sinserts.
c. is snecessary sonly sfor straining snew semployees.
d. must sbe svery sdetailed sto sbe saccurate.
ANS: s A
Standard soperating sprocedures sare swritten sprocedures sthat shelp sachieve sconsistency sand sshould sbe
DIF: Level s2
15. Employee straining stakes splace:
a. after shiring sand sfollowing simplementation sof snew sprocedures.
b. following scompetency sassessment.
c. only sfor snew sinexperienced semployees.
d. as sprocedures sare svalidated.
ANS: s A
Training soccurs swith sall snew semployees sregardless sof stheir sexperience sand sfollowing simplementa
DIF: Level s1
16. Plans sthat sprovide sthe sframework sfor sestablishing squality sassurance sin san sorganization sare:
a. current sgood smanufacturing spractices.
b. standard soperating sprocedures.
c. change scontrol splan.
d. continuous squality simprovement splan.
ANS: s D
The stotal squality smanagement sor scontinuous squality simprovement splan sare spart sof sthe squality sass
sorganization.
DIF: Level s1
17. A sfacility sdoes snot svalidate sa srefrigerator sbefore suse. sWhat sis sa spotential soutcome?
a. The sfacility sis sin sviolation sof scurrent sgood smanufacturing spractices sand
scould sbe scited sby sthe sFood sand sDrug sAdministration.
b. The sfacility sis sin scompliance sif sthe sequipment sfunctions sproperly.
c. The sfacility sis sin scompliance sif sthe sblood sproducts sstored sin sit sare snot stransfused.
d. The sfacility sis sin sviolation sof sAABB sand smay sno slonger sbe smembers.
ANS: s A
Validation sof sequipment sis sa scurrent sgood smanufacturing spractice, swhich sis sa slegal srequirement se
sDrug sAdministration.
DIF: Level s2
MULTIPLE sRESPONSE
1. In sa sroutine saudit sof sa sfacilities sblood scollection sarea, sthe squality sassurance sdepartment sfound stha
sused son sthat sparticular sday shad sexpired. sWhat sis sthe sappropriate scourse sof saction? s(Select sall stha
a. Initiate sa sroot scause sanalysis sand squarantine sthe sblood scollected sin sthe
sexpired sbags.
b. Notify sthe sFDA ssince sthe sexpired sbags swere sdistributed.
c. Change sthe sexpiration sdate son sthe sbags sto savoid slegal sissues.
d. Fire sthe sdonor sroom ssupervisor, sand sdiscard sthe sblood scollected sin sthe
sexpired sbags.
ANS: s A, sB
A sroot scause sanalysis swill sdetermine sthe sfactors sthat scontributed sto sthe serror sand sresult sin sa splan
