TEST BANK nn
BASIC nn& nnAPPLIED nnCONCEPTS nnOF nnBLOOD nnBANKING nnAND nnTRANSFUSION
nnPRACTICES nn5TH nnEDITION
Paula R. Howard
nn nn
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issu
nn nn nn nn nn nn nn nn nn nn nn nn
Bank Howard: Basic & Applied Concepts of Blood Banking and Transfusion Practic
nn nn nn nn nn nn nn nn nn nn nn nn
MULTIPLE nnCHOICE
1. Biosafety nnlevels nndetermine:
a. on nnwhat nnfloor nncertain nninfectious nndisease nntesting nncan nnbe nnperformed.
b. the nndegree nnof nnrisk nnfor nncertain nnareas nnof nna nnhealth nncare nnfacility nnto
exposure nnto nninfectious nndiseases.
nn
c. the nnamount nnof nnventilation nnrequired nnin nna nntransfusion nnservice.
d. how nnmany nnbiohazardous nnwaste nncontainers nna nnlaboratory nnmust nnhave.
ANS: n n B
OSHA nndefines nnbiosafety nnlevels nnbased nnon nnpotential nnexposure nnto nninfectious nnmaterial.
DIF: Level nn1
2. A nnlaboratory nntechnologist nndecided nnshe nnwould nnlike nnto nnbring nnher nnlab nncoat nnhome nnfor nnlaundering
nn many nnwrinkles nnwhen nnit nnwas nnreturned nnby nnthe nnlaboratory’s nnlaundry nnservice. nnIs nnthis nnpractice nna
a. Yes, nnif nnshe nnuses nn10% nnbleach
b. Yes, nnif nnshe nnclears nnit nnwith nnher nnsupervisor
c. Yes, nnas nnlong nnas nnshe nnremoves nnthe nncoat nnand nndoes nnnot nnwear nnit nnhome
d. No, nnbecause nnthe nnlaboratory nnis nna nnbiosafety nnlevel nn2, nnand nnlab nncoats
nnmay nnnot nnbe nnremoved
ANS: n n D
Methods nnof nntransporting nnthe nnlab nncoat nnand nnthe nnrisk nnof nncontamination nndo nnnot nnpermit nnhealth nnca
nncoats nnhome nnfor nncleaning.
DIF: Level nn2
3. Personal nnprotective nnequipment nnincludes:
a. safety nnglasses.
b. splash nnbarriers.
c. masks.
d. All nnof nnthe nnabove
ANS: n n D
Safety nnglasses, nnsplash nnbarriers, nnand nnmasks nnare nntypes nnof nnpersonal nnprotective nndevices.
DIF: Level nn1
4. At nnwhat nnpoint nnin nnthe nnemployment nnprocess nnshould nnsafety nntraining nntake nnplace?
a. During nnorientation nnand nntraining
b. Following nnlab nntraining nnwhen nnemployees nnare nnmore nnfamiliar
with nntheir nnresponsibilities
nn
c. Following nnthe nnemployees’ nnfirst nnevaluation
d. Before nnindependent nnwork nnis nnpermitted nnand nnannually nnthereafter
ANS: n n D
The nnOccupation nnSafety nnand nnHealth nnAdministration nnrequires nnsafety nntraining nnbefore nnindependent
nnannually nnthereafter.
DIF: Level nn1
5. In nnsafety nntraining, nnemployees nnmust nnbecome nnfamiliar nnwith nnall nnof nnthe nnfollowing nn except:
a. tasks nnthat nnhave nnan nninfectious nnrisk.
b. limits nnof nnprotective nnclothing nnand nnequipment.
c. the nnappropriate nnaction nnto nntake nnif nnexposure nnoccurs.
, 7. Which nnof nnthe nnfollowing nnis nntrue nnregarding nngood nnmanufacturing nnpractices nn(GMPs)?
a. GMPs nnare nnlegal nnrequirements nnestablished nnby nnthe nnFood nnand nnDrug nnAdministration.
b. GMPs nnare nnoptional nnguidelines nnwritten nnby nnthe nnAABB.
c. GMPs nnare nnrequired nnonly nnby nnpharmaceutical nncompanies.
d. GMPs nnare nnpart nnof nnthe nnquality nncontrol nnrequirements nnfor nnblood nnproducts.
ANS: n n A
Good nnmanufacturing nnpractices nnare nnrequirements nnestablished nnby nnthe nnFood nnand nnDrug nnAdministr
DIF: Level nn1
8. Which nnof nnthe nnfollowing nnis nnan nnexample nnof nnan nnunacceptable nnrecord-keeping nnprocedure?
a. Using nndittos nnin nncolumns nnto nnsave nntime
b. Recording nnthe nndate nnand nninitials nnnext nnto nna nncorrection
c. Not nndeleting nnthe nnoriginal nnentry nnwhen nnmaking nna nncorrection
d. Always nnusing nnpermanent nnink nnon nnall nnrecords
ANS: n n A
All nnrecords nnmust nnbe nnclearly nnwritten. nnDittos nnare nnunacceptable.
DIF: Level nn1
9. A nntechnologist nnin nntraining nnnoticed nnthat nnthe nnperson nntraining nnher nnhad nnnot nnrecorded nnthe nnresults
nnhelpful, nnshe nncarefully nnrecorded nnthe nnresults nnshe nnsaw nnat nna nnlater nntime, nnusing nnthe nntechnologist’s
nnacceptable nnprocedure?
a. Yes; nnall nnresults nnmust nnbe nnrecorded nnregardless nnof nnwho nndid nnthe nntest.
b. No; nnshe nnshould nnhave nnbrought nnthe nnerror nnto nnthe nntechnologist’s nnattention.
c. Yes; nnbecause nnshe nnused nnthe nnother nntechnologist’s nninitials.
d. Yes; nnas nnlong nnas nnshe nnrecords nnthe nnresult nnin nnpencil.
ANS: n n B
This nnis nnan nnexample nnof nnpoor nnrecord nnkeeping; nnresults nnmust nnbe nnrecorded nnwhen nnthe nntest nnis nnper
nndoing nnthe nntest.
DIF: Level nn3
10. Unacceptable nnquality nncontrol nnresults nnfor nnthe nnantiglobulin nntest nnperformed nnin nntest nntubes nnmay nnb
a. preventive nnmaintenance nnhas nnnot nnbeen nnperformed nnon nnthe nncell nnwasher.
b. the nntechnologist nnperforming nnthe nntest nnwas nnnever nntrained.
c. the nnreagents nnused nnwere nnimproperly nnstored.
d. All nnof nnthe nnabove
ANS: n n D
Training, nnequipment nnmaintenance, nnand nnreagent nnquality nncan nnaffect nnquality nncontrol.
DIF: Level nn2
11. All nnof nnthe nnfollowing nnare nntrue nnregarding nncompetency nntesting nn except:
a. it nnmust nnbe nnperformed nnfollowing nntraining.
b. it nnmust nnbe nnperformed nnon nnan nnannual nnbasis.
c. it nnis nnrequired nnonly nnif nnthe nntechnologist nnhas nnno nnexperience.
d. retraining nnis nnrequired nnif nnthere nnis nna nnfailure nnin nncompetency nntesting.
ANS: n n C
All nnemployees nnmust nnhave nncompetency nntesting nnfollowing nntraining nnand nnannually nnthereafter. nnIf nnth
nncompetency nntesting, nnretraining nnis nnrequired.
DIF: Level nn2
12. Which nnof nnthe nnfollowing nnorganizations nnare nninvolved nnin nnthe nnregulation nnof nnblood nnbanks?
a. The nnJoint nnCommission
, 14. The nnstandard nnoperating nnprocedure nnis nna nndocument nnthat:
a. helps nnachieve nnconsistency nnof nnresults.
b. may nnbe nnsubstituted nnwith nnpackage nninserts.
c. is nnnecessary nnonly nnfor nntraining nnnew nnemployees.
d. must nnbe nnvery nndetailed nnto nnbe nnaccurate.
ANS: n n A
Standard nnoperating nnprocedures nnare nnwritten nnprocedures nnthat nnhelp nnachieve nnconsistency nnand nnshou
DIF: Level nn2
15. Employee nntraining nntakes nnplace:
a. after nnhiring nnand nnfollowing nnimplementation nnof nnnew nnprocedures.
b. following nncompetency nnassessment.
c. only nnfor nnnew nninexperienced nnemployees.
d. as nnprocedures nnare nnvalidated.
ANS: n n A
Training nnoccurs nnwith nnall nnnew nnemployees nnregardless nnof nntheir nnexperience nnand nnfollowing nnimplem
nnprocedures.
DIF: Level nn1
16. Plans nnthat nnprovide nnthe nnframework nnfor nnestablishing nnquality nnassurance nnin nnan nnorganization nnare:
a. current nngood nnmanufacturing nnpractices.
b. standard nnoperating nnprocedures.
c. change nncontrol nnplan.
d. continuous nnquality nnimprovement nnplan.
ANS: n n D
The nntotal nnquality nnmanagement nnor nncontinuous nnquality nnimprovement nnplan nnare nnpart nnof nnthe nnquali
nnan nnorganization.
DIF: Level nn1
17. A nnfacility nndoes nnnot nnvalidate nna nnrefrigerator nnbefore nnuse. nnWhat nnis nna nnpotential nnoutcome?
a. The nnfacility nnis nnin nnviolation nnof nncurrent nngood nnmanufacturing nnpractices nnand
could nnbe nncited nnby nnthe nnFood nnand nnDrug nnAdministration.
nn
b. The nnfacility nnis nnin nncompliance nnif nnthe nnequipment nnfunctions nnproperly.
c. The nnfacility nnis nnin nncompliance nnif nnthe nnblood nnproducts nnstored nnin nnit nnare nnnot nntransfused.
d. The nnfacility nnis nnin nnviolation nnof nnAABB nnand nnmay nnno nnlonger nnbe nnmembers.
ANS: n n A
Validation nnof nnequipment nnis nna nncurrent nngood nnmanufacturing nnpractice, nnwhich nnis nna nnlegal nnrequirem
nnFood nnand nnDrug nnAdministration.
DIF: Level nn2
MULTIPLE nnRESPONSE
1. In nna nnroutine nnaudit nnof nna nnfacilities nnblood nncollection nnarea, nnthe nnquality nnassurance nndepartment nnfou
nnbags nnused nnon nnthat nnparticular nnday nnhad nnexpired. nnWhat nnis nnthe nnappropriate nncourse nnof nnaction? nn(
nnapply.)
a. Initiate nna nnroot nncause nnanalysis nnand nnquarantine nnthe nnblood nncollected nnin
nnthe nnexpired nnbags.
b. Notify nnthe nnFDA nnsince nnthe nnexpired nnbags nnwere nndistributed.
c. Change nnthe nnexpiration nndate nnon nnthe nnbags nnto nnavoid nnlegal nnissues.
d. Fire nnthe nndonor nnroom nnsupervisor, nnand nndiscard nnthe nnblood nncollected nnin
nnthe nnexpired nnbags.
BASIC nn& nnAPPLIED nnCONCEPTS nnOF nnBLOOD nnBANKING nnAND nnTRANSFUSION
nnPRACTICES nn5TH nnEDITION
Paula R. Howard
nn nn
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issu
nn nn nn nn nn nn nn nn nn nn nn nn
Bank Howard: Basic & Applied Concepts of Blood Banking and Transfusion Practic
nn nn nn nn nn nn nn nn nn nn nn nn
MULTIPLE nnCHOICE
1. Biosafety nnlevels nndetermine:
a. on nnwhat nnfloor nncertain nninfectious nndisease nntesting nncan nnbe nnperformed.
b. the nndegree nnof nnrisk nnfor nncertain nnareas nnof nna nnhealth nncare nnfacility nnto
exposure nnto nninfectious nndiseases.
nn
c. the nnamount nnof nnventilation nnrequired nnin nna nntransfusion nnservice.
d. how nnmany nnbiohazardous nnwaste nncontainers nna nnlaboratory nnmust nnhave.
ANS: n n B
OSHA nndefines nnbiosafety nnlevels nnbased nnon nnpotential nnexposure nnto nninfectious nnmaterial.
DIF: Level nn1
2. A nnlaboratory nntechnologist nndecided nnshe nnwould nnlike nnto nnbring nnher nnlab nncoat nnhome nnfor nnlaundering
nn many nnwrinkles nnwhen nnit nnwas nnreturned nnby nnthe nnlaboratory’s nnlaundry nnservice. nnIs nnthis nnpractice nna
a. Yes, nnif nnshe nnuses nn10% nnbleach
b. Yes, nnif nnshe nnclears nnit nnwith nnher nnsupervisor
c. Yes, nnas nnlong nnas nnshe nnremoves nnthe nncoat nnand nndoes nnnot nnwear nnit nnhome
d. No, nnbecause nnthe nnlaboratory nnis nna nnbiosafety nnlevel nn2, nnand nnlab nncoats
nnmay nnnot nnbe nnremoved
ANS: n n D
Methods nnof nntransporting nnthe nnlab nncoat nnand nnthe nnrisk nnof nncontamination nndo nnnot nnpermit nnhealth nnca
nncoats nnhome nnfor nncleaning.
DIF: Level nn2
3. Personal nnprotective nnequipment nnincludes:
a. safety nnglasses.
b. splash nnbarriers.
c. masks.
d. All nnof nnthe nnabove
ANS: n n D
Safety nnglasses, nnsplash nnbarriers, nnand nnmasks nnare nntypes nnof nnpersonal nnprotective nndevices.
DIF: Level nn1
4. At nnwhat nnpoint nnin nnthe nnemployment nnprocess nnshould nnsafety nntraining nntake nnplace?
a. During nnorientation nnand nntraining
b. Following nnlab nntraining nnwhen nnemployees nnare nnmore nnfamiliar
with nntheir nnresponsibilities
nn
c. Following nnthe nnemployees’ nnfirst nnevaluation
d. Before nnindependent nnwork nnis nnpermitted nnand nnannually nnthereafter
ANS: n n D
The nnOccupation nnSafety nnand nnHealth nnAdministration nnrequires nnsafety nntraining nnbefore nnindependent
nnannually nnthereafter.
DIF: Level nn1
5. In nnsafety nntraining, nnemployees nnmust nnbecome nnfamiliar nnwith nnall nnof nnthe nnfollowing nn except:
a. tasks nnthat nnhave nnan nninfectious nnrisk.
b. limits nnof nnprotective nnclothing nnand nnequipment.
c. the nnappropriate nnaction nnto nntake nnif nnexposure nnoccurs.
, 7. Which nnof nnthe nnfollowing nnis nntrue nnregarding nngood nnmanufacturing nnpractices nn(GMPs)?
a. GMPs nnare nnlegal nnrequirements nnestablished nnby nnthe nnFood nnand nnDrug nnAdministration.
b. GMPs nnare nnoptional nnguidelines nnwritten nnby nnthe nnAABB.
c. GMPs nnare nnrequired nnonly nnby nnpharmaceutical nncompanies.
d. GMPs nnare nnpart nnof nnthe nnquality nncontrol nnrequirements nnfor nnblood nnproducts.
ANS: n n A
Good nnmanufacturing nnpractices nnare nnrequirements nnestablished nnby nnthe nnFood nnand nnDrug nnAdministr
DIF: Level nn1
8. Which nnof nnthe nnfollowing nnis nnan nnexample nnof nnan nnunacceptable nnrecord-keeping nnprocedure?
a. Using nndittos nnin nncolumns nnto nnsave nntime
b. Recording nnthe nndate nnand nninitials nnnext nnto nna nncorrection
c. Not nndeleting nnthe nnoriginal nnentry nnwhen nnmaking nna nncorrection
d. Always nnusing nnpermanent nnink nnon nnall nnrecords
ANS: n n A
All nnrecords nnmust nnbe nnclearly nnwritten. nnDittos nnare nnunacceptable.
DIF: Level nn1
9. A nntechnologist nnin nntraining nnnoticed nnthat nnthe nnperson nntraining nnher nnhad nnnot nnrecorded nnthe nnresults
nnhelpful, nnshe nncarefully nnrecorded nnthe nnresults nnshe nnsaw nnat nna nnlater nntime, nnusing nnthe nntechnologist’s
nnacceptable nnprocedure?
a. Yes; nnall nnresults nnmust nnbe nnrecorded nnregardless nnof nnwho nndid nnthe nntest.
b. No; nnshe nnshould nnhave nnbrought nnthe nnerror nnto nnthe nntechnologist’s nnattention.
c. Yes; nnbecause nnshe nnused nnthe nnother nntechnologist’s nninitials.
d. Yes; nnas nnlong nnas nnshe nnrecords nnthe nnresult nnin nnpencil.
ANS: n n B
This nnis nnan nnexample nnof nnpoor nnrecord nnkeeping; nnresults nnmust nnbe nnrecorded nnwhen nnthe nntest nnis nnper
nndoing nnthe nntest.
DIF: Level nn3
10. Unacceptable nnquality nncontrol nnresults nnfor nnthe nnantiglobulin nntest nnperformed nnin nntest nntubes nnmay nnb
a. preventive nnmaintenance nnhas nnnot nnbeen nnperformed nnon nnthe nncell nnwasher.
b. the nntechnologist nnperforming nnthe nntest nnwas nnnever nntrained.
c. the nnreagents nnused nnwere nnimproperly nnstored.
d. All nnof nnthe nnabove
ANS: n n D
Training, nnequipment nnmaintenance, nnand nnreagent nnquality nncan nnaffect nnquality nncontrol.
DIF: Level nn2
11. All nnof nnthe nnfollowing nnare nntrue nnregarding nncompetency nntesting nn except:
a. it nnmust nnbe nnperformed nnfollowing nntraining.
b. it nnmust nnbe nnperformed nnon nnan nnannual nnbasis.
c. it nnis nnrequired nnonly nnif nnthe nntechnologist nnhas nnno nnexperience.
d. retraining nnis nnrequired nnif nnthere nnis nna nnfailure nnin nncompetency nntesting.
ANS: n n C
All nnemployees nnmust nnhave nncompetency nntesting nnfollowing nntraining nnand nnannually nnthereafter. nnIf nnth
nncompetency nntesting, nnretraining nnis nnrequired.
DIF: Level nn2
12. Which nnof nnthe nnfollowing nnorganizations nnare nninvolved nnin nnthe nnregulation nnof nnblood nnbanks?
a. The nnJoint nnCommission
, 14. The nnstandard nnoperating nnprocedure nnis nna nndocument nnthat:
a. helps nnachieve nnconsistency nnof nnresults.
b. may nnbe nnsubstituted nnwith nnpackage nninserts.
c. is nnnecessary nnonly nnfor nntraining nnnew nnemployees.
d. must nnbe nnvery nndetailed nnto nnbe nnaccurate.
ANS: n n A
Standard nnoperating nnprocedures nnare nnwritten nnprocedures nnthat nnhelp nnachieve nnconsistency nnand nnshou
DIF: Level nn2
15. Employee nntraining nntakes nnplace:
a. after nnhiring nnand nnfollowing nnimplementation nnof nnnew nnprocedures.
b. following nncompetency nnassessment.
c. only nnfor nnnew nninexperienced nnemployees.
d. as nnprocedures nnare nnvalidated.
ANS: n n A
Training nnoccurs nnwith nnall nnnew nnemployees nnregardless nnof nntheir nnexperience nnand nnfollowing nnimplem
nnprocedures.
DIF: Level nn1
16. Plans nnthat nnprovide nnthe nnframework nnfor nnestablishing nnquality nnassurance nnin nnan nnorganization nnare:
a. current nngood nnmanufacturing nnpractices.
b. standard nnoperating nnprocedures.
c. change nncontrol nnplan.
d. continuous nnquality nnimprovement nnplan.
ANS: n n D
The nntotal nnquality nnmanagement nnor nncontinuous nnquality nnimprovement nnplan nnare nnpart nnof nnthe nnquali
nnan nnorganization.
DIF: Level nn1
17. A nnfacility nndoes nnnot nnvalidate nna nnrefrigerator nnbefore nnuse. nnWhat nnis nna nnpotential nnoutcome?
a. The nnfacility nnis nnin nnviolation nnof nncurrent nngood nnmanufacturing nnpractices nnand
could nnbe nncited nnby nnthe nnFood nnand nnDrug nnAdministration.
nn
b. The nnfacility nnis nnin nncompliance nnif nnthe nnequipment nnfunctions nnproperly.
c. The nnfacility nnis nnin nncompliance nnif nnthe nnblood nnproducts nnstored nnin nnit nnare nnnot nntransfused.
d. The nnfacility nnis nnin nnviolation nnof nnAABB nnand nnmay nnno nnlonger nnbe nnmembers.
ANS: n n A
Validation nnof nnequipment nnis nna nncurrent nngood nnmanufacturing nnpractice, nnwhich nnis nna nnlegal nnrequirem
nnFood nnand nnDrug nnAdministration.
DIF: Level nn2
MULTIPLE nnRESPONSE
1. In nna nnroutine nnaudit nnof nna nnfacilities nnblood nncollection nnarea, nnthe nnquality nnassurance nndepartment nnfou
nnbags nnused nnon nnthat nnparticular nnday nnhad nnexpired. nnWhat nnis nnthe nnappropriate nncourse nnof nnaction? nn(
nnapply.)
a. Initiate nna nnroot nncause nnanalysis nnand nnquarantine nnthe nnblood nncollected nnin
nnthe nnexpired nnbags.
b. Notify nnthe nnFDA nnsince nnthe nnexpired nnbags nnwere nndistributed.
c. Change nnthe nnexpiration nndate nnon nnthe nnbags nnto nnavoid nnlegal nnissues.
d. Fire nnthe nndonor nnroom nnsupervisor, nnand nndiscard nnthe nnblood nncollected nnin
nnthe nnexpired nnbags.
