TESTBANK n
BASICn&nAPPLIEDnCONCEPTSnOFnBLOODnBANKINGnANDnTRANSFUSIONnPRAC
TICESn5THnEDITION
Paula R. Howard
n n
, Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank Howard:
n n n n n n n n n n n n n n n n n n
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
n n n n n n n n n n n
MULTIPLEnCHOICE
1. Biosafetynlevelsndetermine:
n
a. onnwhatnfloorncertainninfectiousndiseasentestingncannbenperformed.
b. thendegreenofnrisknforncertainnareasnofnanhealthncarenfacilityntonexposurentoni
nfectiousndiseases.
c. thenamountnofnventilationnrequiredninnantransfusionnservice.
d. hownmanynbiohazardousnwastencontainersnanlaboratorynmustnhave.
ANS:n B
OSHAndefinesnbiosafetynlevelsnbasednonnpotentialnexposurentoninfectiousnmaterial.
DIF: Leveln1
2. Anlaboratoryntechnologistndecidednshenwouldnlikentonbringnhernlabncoatnhomenfornlaunderingnbecausenitnhadntoonmanynwrinklesnwhennitn
wasnreturnednbynthenlaboratory’snlaundrynservice.nIsnthisnpracticenacceptable?
a. Yes,nifnshenusesn10%nbleach
b. Yes,nifnshenclearsnitnwithnhernsupervisor
c. Yes,nasnlongnasnshenremovesnthencoatnandndoesnnotnwearnitnhome
d. No,nbecausenthenlaboratorynisnanbiosafetynleveln2,nandnlabncoatsnmaynnotnbenr
emoved
ANS:n D
Methodsnofntransportingnthenlabncoatnandnthenrisknofncontaminationndonnotnpermitnhealthncarenworkersntonbringnlabncoatsnhomenforncleanin
g.
DIF: Leveln2
3. Personalnprotectivenequipmentnincludes:
a. safetynglasses.
b. splashnbarriers.
c. masks.
d. Allnofnthenabove
ANS:n D
Safetynglasses,nsplashnbarriers,nandnmasksnarentypesnofnpersonalnprotectivendevices.
DIF: Leveln1
4. Atnwhatnpointninnthenemploymentnprocessnshouldnsafetyntrainingntakenplace?
a. Duringnorientationnandntraining
b. Followingnlabntrainingnwhennemployeesnarenmorenfamiliarnwithntheirnr
esponsibilities
c. Followingnthenemployees’nfirstnevaluation
d. Beforenindependentnworknisnpermittednandnannuallynthereafter
ANS:n D
ThenOccupationnSafetynandnHealthnAdministrationnrequiresnsafetyntrainingnbeforenindependentnworknisnpermittednandnannuallynthereafter
.
DIF: Leveln1
5. Innsafetyntraining,nemployeesnmustnbecomenfamiliarnwithnallnofnthenfollowingnexcept:
a. tasksnthatnhavenanninfectiousnrisk.
b. limitsnofnprotectivenclothingnandnequipment.
c. thenappropriatenactionntontakenifnexposurenoccurs.
d. howntonperformncardiopulmonarynresuscitationnonnandonornornothernemployee.
ANS:n D
ThenOccupationalnSafetynandnHealthnAdministrationnrequirementsnincludenallnofnthosenlistednexceptncardiopulmonarynresuscitation.
DIF: Leveln1
6. Bloodnirradiatorsnrequirenallnofnthenfollowingnsafetynproceduresn except:
a. properntraining.
b. thatnthenusernhavenandegreeninnradiology.
c. equipmentnleakndetection.
d. personalnprotectivenequipment.
ANS:n B
Bloodnbanknandntransfusionnservicentechnologistsnrequirentrainingnbutnnotnandegreentonusenanbloodnirradiator.
DIF: Leveln2
Copyrightn©n2021,nElseviernInc.nAllnrightsnreserved. 1
, 7. Whichnofnthenfollowingnisntruenregardingngoodnmanufacturingnpracticesn(GMPs)?
a. GMPsnarenlegalnrequirementsnestablishednbynthenFoodnandnDrugnAdministration.
b. GMPsnarenoptionalnguidelinesnwrittennbynthenAABB.
c. GMPsnarenrequirednonlynbynpharmaceuticalncompanies.
d. GMPsnarenpartnofnthenqualityncontrolnrequirementsnfornbloodnproducts.
ANS:n A
GoodnmanufacturingnpracticesnarenrequirementsnestablishednbynthenFoodnandnDrugnAdministration.
DIF: Leveln1
8. Whichnofnthenfollowingnisnannexamplenofnannunacceptablenrecord-keepingnprocedure?
a. Usingndittosninncolumnsntonsaventime
b. Recordingnthendatenandninitialsnnextntonancorrection
c. Notndeletingnthenoriginalnentrynwhennmakingnancorrection
d. Alwaysnusingnpermanentninknonnallnrecords
ANS:n A
Allnrecordsnmustnbenclearlynwritten.nDittosnarenunacceptable.
DIF: Leveln1
9. Antechnologistninntrainingnnoticednthatnthenpersonntrainingnhernhadnnotnrecordednthenresultsnofnantest.nTonbenhelpful,nshencarefullynre
cordednthenresultsnshensawnatnanlaterntime,nusingnthentechnologist’sninitials.nIsnthisnannacceptablenprocedure?
a. Yes;nallnresultsnmustnbenrecordednregardlessnofnwhondidnthentest.
b. No;nshenshouldnhavenbroughtnthenerrorntonthentechnologist’snattention.
c. Yes;nbecausenshenusednthenotherntechnologist’sninitials.
d. Yes;nasnlongnasnshenrecordsnthenresultninnpencil.
ANS:n B
Thisnisnannexamplenofnpoornrecordnkeeping;nresultsnmustnbenrecordednwhennthentestnisnperformednandnbynthenpersonndoingnthentest.
DIF: Leveln3
10. Unacceptablenqualityncontrolnresultsnfornthenantiglobulinntestnperformedninntestntubesnmaynbennoticednif:
a. preventivenmaintenancenhasnnotnbeennperformednonnthencellnwasher.
b. thentechnologistnperformingnthentestnwasnneverntrained.
c. thenreagentsnusednwerenimproperlynstored.
d. Allnofnthenabove
ANS:n D
Training,nequipmentnmaintenance,nandnreagentnqualityncannaffectnqualityncontrol.
DIF: Leveln2
11. Allnofnthenfollowingnarentruenregardingncompetencyntestingn except:
a. itnmustnbenperformednfollowingntraining.
b. itnmustnbenperformednonnannannualnbasis.
c. itnisnrequirednonlynifnthentechnologistnhasnnonexperience.
d. retrainingnisnrequirednifntherenisnanfailureninncompetencyntesting.
ANS:n C
Allnemployeesnmustnhavencompetencyntestingnfollowingntrainingnandnannuallynthereafter.nIfntherenisnanfailureninncompetencyntesting,nretra
iningnisnrequired.
DIF: Leveln2
12. Whichnofnthenfollowingnorganizationsnareninvolvedninnthenregulationnofnbloodnbanks?
a. ThenJointnCommission
b. AABB
c. CollegenofnAmericannPathologists
d. FoodnandnDrugnAdministration
ANS:n D
ThenFoodnandnDrugnAdministrationnregulatesnbloodnbanks,nwhereasnthenothernorganizationsnareninvolvedninnaccreditation.
DIF: Leveln1
13. Allnofnthenfollowingnarenresponsibilitiesnofnthenqualitynassurancendepartmentnofnanbloodnbankn except:
a. performingninternalnaudits.
b. performingnqualityncontrol.
c. reviewingnstandardnoperatingnprocedures.
d. reviewingnandnapprovingntrainingnprograms.
ANS:n B
Qualityncontrolnisnperformedninnthenlaboratory,nnotnbynthenqualitynassurancendepartment.
DIF: Leveln2
Copyrightn©n2021,nElseviernInc.nAllnrightsnreserved. 2
, 14. Thenstandardnoperatingnprocedurenisnandocumentnthat:
a. helpsnachievenconsistencynofnresults.
b. maynbensubstitutednwithnpackageninserts.
c. isnnecessarynonlynforntrainingnnewnemployees.
d. mustnbenveryndetailedntonbenaccurate.
ANS:n A
Standardnoperatingnproceduresnarenwrittennproceduresnthatnhelpnachievenconsistencynandnshouldnbenclearnandnconcise.
DIF: Leveln2
15. Employeentrainingntakesnplace:
a. afternhiringnandnfollowingnimplementationnofnnewnprocedures.
b. followingncompetencynassessment.
c. onlynfornnewninexperiencednemployees.
d. asnproceduresnarenvalidated.
ANS:n A
Trainingnoccursnwithnallnnewnemployeesnregardlessnofntheirnexperiencenandnfollowingnimplementationnofnnewnprocedures.
DIF: Leveln1
16. Plansnthatnprovidenthenframeworknfornestablishingnqualitynassuranceninnannorganizationnare:
a. currentngoodnmanufacturingnpractices.
b. standardnoperatingnprocedures.
c. changencontrolnplan.
d. continuousnqualitynimprovementnplan.
ANS:n D
Thentotalnqualitynmanagementnorncontinuousnqualitynimprovementnplannarenpartnofnthenqualitynassurancenprogramninnannorganization.
DIF: Leveln1
17. Anfacilityndoesnnotnvalidatenanrefrigeratornbeforenuse.nWhatnisnanpotentialnoutcome?
a. Thenfacilitynisninnviolationnofncurrentngoodnmanufacturingnpracticesnandncouldnbenc
itednbynthenFoodnandnDrugnAdministration.
b. Thenfacilitynisninncompliancenifnthenequipmentnfunctionsnproperly.
c. Thenfacilitynisninncompliancenifnthenbloodnproductsnstoredninnitnarennotntransfused.
d. ThenfacilitynisninnviolationnofnAABBnandnmaynnonlongernbenmembers.
ANS:n A
Validationnofnequipmentnisnancurrentngoodnmanufacturingnpractice,nwhichnisnanlegalnrequirementnestablishednbynthenFoodnandnDrugnAdmi
nistration.
DIF: Leveln2
MULTIPLEnRESPONSE
1. Innanroutinenauditnofnanfacilitiesnbloodncollectionnarea,nthenqualitynassurancendepartmentnfoundnthatnthenbloodnbagsnusednonnthatnp
articularndaynhadnexpired.nWhatnisnthenappropriatencoursenofnaction?n(Selectnallnthatnapply.)
a. Initiatenanrootncausenanalysisnandnquarantinenthenbloodncollectedninnthenexpirednb
ags.
b. NotifynthenFDAnsincenthenexpirednbagsnwerendistributed.
c. Changenthenexpirationndatenonnthenbagsntonavoidnlegalnissues.
d. Firenthendonornroomnsupervisor,nandndiscardnthenbloodncollectedninnthenexpirednb
ags.
ANS:n A,nB
Anrootncausenanalysisnwillndeterminenthenfactorsnthatncontributedntonthenerrornandnresultninnanplanntonpreventnfurthernerrors.
DIF: Leveln3
2. Severalnunitsnwerenreleasedntonanhospitalnbynmistakenbeforenallnviralnmarkerntestingnwasncompleted.nWhatnisnthenappropriatencourseno
fnaction?n(Selectnallnthatnapply.)
a. Thenerrornisnreportable,nandnthenFoodnandnDrugnAdministrationnmustnbencontacted.
b. Callnthenhospitalnandnrequestnanquarantinenofnthenremainingnproductsninninventory.
c. Performnanrootncausenanalysisnand,nifnthenunitsnarenfoundntonbennegative,nreportnthent
estnresultntonthenhospital.
d. Recallnonlynthenunitsnthatnarenpositivenfornviralnmarkers.
ANS:n A,nB
ReleasenofnuntestednunitsnisnanreportablenerrorntonthenFoodnandnDrugnAdministrationnandnthenhospitalnmustnbennotifiedntonquarantinenan
ynremainingnproductsnpendingncompletionnofntestnresults.
DIF: Leveln3
Copyrightn©n2021,nElseviernInc.nAllnrightsnreserved. 3
BASICn&nAPPLIEDnCONCEPTSnOFnBLOODnBANKINGnANDnTRANSFUSIONnPRAC
TICESn5THnEDITION
Paula R. Howard
n n
, Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank Howard:
n n n n n n n n n n n n n n n n n n
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
n n n n n n n n n n n
MULTIPLEnCHOICE
1. Biosafetynlevelsndetermine:
n
a. onnwhatnfloorncertainninfectiousndiseasentestingncannbenperformed.
b. thendegreenofnrisknforncertainnareasnofnanhealthncarenfacilityntonexposurentoni
nfectiousndiseases.
c. thenamountnofnventilationnrequiredninnantransfusionnservice.
d. hownmanynbiohazardousnwastencontainersnanlaboratorynmustnhave.
ANS:n B
OSHAndefinesnbiosafetynlevelsnbasednonnpotentialnexposurentoninfectiousnmaterial.
DIF: Leveln1
2. Anlaboratoryntechnologistndecidednshenwouldnlikentonbringnhernlabncoatnhomenfornlaunderingnbecausenitnhadntoonmanynwrinklesnwhennitn
wasnreturnednbynthenlaboratory’snlaundrynservice.nIsnthisnpracticenacceptable?
a. Yes,nifnshenusesn10%nbleach
b. Yes,nifnshenclearsnitnwithnhernsupervisor
c. Yes,nasnlongnasnshenremovesnthencoatnandndoesnnotnwearnitnhome
d. No,nbecausenthenlaboratorynisnanbiosafetynleveln2,nandnlabncoatsnmaynnotnbenr
emoved
ANS:n D
Methodsnofntransportingnthenlabncoatnandnthenrisknofncontaminationndonnotnpermitnhealthncarenworkersntonbringnlabncoatsnhomenforncleanin
g.
DIF: Leveln2
3. Personalnprotectivenequipmentnincludes:
a. safetynglasses.
b. splashnbarriers.
c. masks.
d. Allnofnthenabove
ANS:n D
Safetynglasses,nsplashnbarriers,nandnmasksnarentypesnofnpersonalnprotectivendevices.
DIF: Leveln1
4. Atnwhatnpointninnthenemploymentnprocessnshouldnsafetyntrainingntakenplace?
a. Duringnorientationnandntraining
b. Followingnlabntrainingnwhennemployeesnarenmorenfamiliarnwithntheirnr
esponsibilities
c. Followingnthenemployees’nfirstnevaluation
d. Beforenindependentnworknisnpermittednandnannuallynthereafter
ANS:n D
ThenOccupationnSafetynandnHealthnAdministrationnrequiresnsafetyntrainingnbeforenindependentnworknisnpermittednandnannuallynthereafter
.
DIF: Leveln1
5. Innsafetyntraining,nemployeesnmustnbecomenfamiliarnwithnallnofnthenfollowingnexcept:
a. tasksnthatnhavenanninfectiousnrisk.
b. limitsnofnprotectivenclothingnandnequipment.
c. thenappropriatenactionntontakenifnexposurenoccurs.
d. howntonperformncardiopulmonarynresuscitationnonnandonornornothernemployee.
ANS:n D
ThenOccupationalnSafetynandnHealthnAdministrationnrequirementsnincludenallnofnthosenlistednexceptncardiopulmonarynresuscitation.
DIF: Leveln1
6. Bloodnirradiatorsnrequirenallnofnthenfollowingnsafetynproceduresn except:
a. properntraining.
b. thatnthenusernhavenandegreeninnradiology.
c. equipmentnleakndetection.
d. personalnprotectivenequipment.
ANS:n B
Bloodnbanknandntransfusionnservicentechnologistsnrequirentrainingnbutnnotnandegreentonusenanbloodnirradiator.
DIF: Leveln2
Copyrightn©n2021,nElseviernInc.nAllnrightsnreserved. 1
, 7. Whichnofnthenfollowingnisntruenregardingngoodnmanufacturingnpracticesn(GMPs)?
a. GMPsnarenlegalnrequirementsnestablishednbynthenFoodnandnDrugnAdministration.
b. GMPsnarenoptionalnguidelinesnwrittennbynthenAABB.
c. GMPsnarenrequirednonlynbynpharmaceuticalncompanies.
d. GMPsnarenpartnofnthenqualityncontrolnrequirementsnfornbloodnproducts.
ANS:n A
GoodnmanufacturingnpracticesnarenrequirementsnestablishednbynthenFoodnandnDrugnAdministration.
DIF: Leveln1
8. Whichnofnthenfollowingnisnannexamplenofnannunacceptablenrecord-keepingnprocedure?
a. Usingndittosninncolumnsntonsaventime
b. Recordingnthendatenandninitialsnnextntonancorrection
c. Notndeletingnthenoriginalnentrynwhennmakingnancorrection
d. Alwaysnusingnpermanentninknonnallnrecords
ANS:n A
Allnrecordsnmustnbenclearlynwritten.nDittosnarenunacceptable.
DIF: Leveln1
9. Antechnologistninntrainingnnoticednthatnthenpersonntrainingnhernhadnnotnrecordednthenresultsnofnantest.nTonbenhelpful,nshencarefullynre
cordednthenresultsnshensawnatnanlaterntime,nusingnthentechnologist’sninitials.nIsnthisnannacceptablenprocedure?
a. Yes;nallnresultsnmustnbenrecordednregardlessnofnwhondidnthentest.
b. No;nshenshouldnhavenbroughtnthenerrorntonthentechnologist’snattention.
c. Yes;nbecausenshenusednthenotherntechnologist’sninitials.
d. Yes;nasnlongnasnshenrecordsnthenresultninnpencil.
ANS:n B
Thisnisnannexamplenofnpoornrecordnkeeping;nresultsnmustnbenrecordednwhennthentestnisnperformednandnbynthenpersonndoingnthentest.
DIF: Leveln3
10. Unacceptablenqualityncontrolnresultsnfornthenantiglobulinntestnperformedninntestntubesnmaynbennoticednif:
a. preventivenmaintenancenhasnnotnbeennperformednonnthencellnwasher.
b. thentechnologistnperformingnthentestnwasnneverntrained.
c. thenreagentsnusednwerenimproperlynstored.
d. Allnofnthenabove
ANS:n D
Training,nequipmentnmaintenance,nandnreagentnqualityncannaffectnqualityncontrol.
DIF: Leveln2
11. Allnofnthenfollowingnarentruenregardingncompetencyntestingn except:
a. itnmustnbenperformednfollowingntraining.
b. itnmustnbenperformednonnannannualnbasis.
c. itnisnrequirednonlynifnthentechnologistnhasnnonexperience.
d. retrainingnisnrequirednifntherenisnanfailureninncompetencyntesting.
ANS:n C
Allnemployeesnmustnhavencompetencyntestingnfollowingntrainingnandnannuallynthereafter.nIfntherenisnanfailureninncompetencyntesting,nretra
iningnisnrequired.
DIF: Leveln2
12. Whichnofnthenfollowingnorganizationsnareninvolvedninnthenregulationnofnbloodnbanks?
a. ThenJointnCommission
b. AABB
c. CollegenofnAmericannPathologists
d. FoodnandnDrugnAdministration
ANS:n D
ThenFoodnandnDrugnAdministrationnregulatesnbloodnbanks,nwhereasnthenothernorganizationsnareninvolvedninnaccreditation.
DIF: Leveln1
13. Allnofnthenfollowingnarenresponsibilitiesnofnthenqualitynassurancendepartmentnofnanbloodnbankn except:
a. performingninternalnaudits.
b. performingnqualityncontrol.
c. reviewingnstandardnoperatingnprocedures.
d. reviewingnandnapprovingntrainingnprograms.
ANS:n B
Qualityncontrolnisnperformedninnthenlaboratory,nnotnbynthenqualitynassurancendepartment.
DIF: Leveln2
Copyrightn©n2021,nElseviernInc.nAllnrightsnreserved. 2
, 14. Thenstandardnoperatingnprocedurenisnandocumentnthat:
a. helpsnachievenconsistencynofnresults.
b. maynbensubstitutednwithnpackageninserts.
c. isnnecessarynonlynforntrainingnnewnemployees.
d. mustnbenveryndetailedntonbenaccurate.
ANS:n A
Standardnoperatingnproceduresnarenwrittennproceduresnthatnhelpnachievenconsistencynandnshouldnbenclearnandnconcise.
DIF: Leveln2
15. Employeentrainingntakesnplace:
a. afternhiringnandnfollowingnimplementationnofnnewnprocedures.
b. followingncompetencynassessment.
c. onlynfornnewninexperiencednemployees.
d. asnproceduresnarenvalidated.
ANS:n A
Trainingnoccursnwithnallnnewnemployeesnregardlessnofntheirnexperiencenandnfollowingnimplementationnofnnewnprocedures.
DIF: Leveln1
16. Plansnthatnprovidenthenframeworknfornestablishingnqualitynassuranceninnannorganizationnare:
a. currentngoodnmanufacturingnpractices.
b. standardnoperatingnprocedures.
c. changencontrolnplan.
d. continuousnqualitynimprovementnplan.
ANS:n D
Thentotalnqualitynmanagementnorncontinuousnqualitynimprovementnplannarenpartnofnthenqualitynassurancenprogramninnannorganization.
DIF: Leveln1
17. Anfacilityndoesnnotnvalidatenanrefrigeratornbeforenuse.nWhatnisnanpotentialnoutcome?
a. Thenfacilitynisninnviolationnofncurrentngoodnmanufacturingnpracticesnandncouldnbenc
itednbynthenFoodnandnDrugnAdministration.
b. Thenfacilitynisninncompliancenifnthenequipmentnfunctionsnproperly.
c. Thenfacilitynisninncompliancenifnthenbloodnproductsnstoredninnitnarennotntransfused.
d. ThenfacilitynisninnviolationnofnAABBnandnmaynnonlongernbenmembers.
ANS:n A
Validationnofnequipmentnisnancurrentngoodnmanufacturingnpractice,nwhichnisnanlegalnrequirementnestablishednbynthenFoodnandnDrugnAdmi
nistration.
DIF: Leveln2
MULTIPLEnRESPONSE
1. Innanroutinenauditnofnanfacilitiesnbloodncollectionnarea,nthenqualitynassurancendepartmentnfoundnthatnthenbloodnbagsnusednonnthatnp
articularndaynhadnexpired.nWhatnisnthenappropriatencoursenofnaction?n(Selectnallnthatnapply.)
a. Initiatenanrootncausenanalysisnandnquarantinenthenbloodncollectedninnthenexpirednb
ags.
b. NotifynthenFDAnsincenthenexpirednbagsnwerendistributed.
c. Changenthenexpirationndatenonnthenbagsntonavoidnlegalnissues.
d. Firenthendonornroomnsupervisor,nandndiscardnthenbloodncollectedninnthenexpirednb
ags.
ANS:n A,nB
Anrootncausenanalysisnwillndeterminenthenfactorsnthatncontributedntonthenerrornandnresultninnanplanntonpreventnfurthernerrors.
DIF: Leveln3
2. Severalnunitsnwerenreleasedntonanhospitalnbynmistakenbeforenallnviralnmarkerntestingnwasncompleted.nWhatnisnthenappropriatencourseno
fnaction?n(Selectnallnthatnapply.)
a. Thenerrornisnreportable,nandnthenFoodnandnDrugnAdministrationnmustnbencontacted.
b. Callnthenhospitalnandnrequestnanquarantinenofnthenremainingnproductsninninventory.
c. Performnanrootncausenanalysisnand,nifnthenunitsnarenfoundntonbennegative,nreportnthent
estnresultntonthenhospital.
d. Recallnonlynthenunitsnthatnarenpositivenfornviralnmarkers.
ANS:n A,nB
ReleasenofnuntestednunitsnisnanreportablenerrorntonthenFoodnandnDrugnAdministrationnandnthenhospitalnmustnbennotifiedntonquarantinenan
ynremainingnproductsnpendingncompletionnofntestnresults.
DIF: Leveln3
Copyrightn©n2021,nElseviernInc.nAllnrightsnreserved. 3
