TESTBANK d
BASICd&dAPPLIEDdCONCEPTSdOFdBLOODdBANKINGdANDdTRANSFUSIONdPRAC
TICESd5THdEDITION
Paula R. Howard
d d
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Bl
d d d d d d d d d d d d d d d
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
d d d d d d d d d d d
MULTIPLEdCHOICE
1. Biosafetydlevelsddetermine:
a. ondwhatdfloordcertaindinfectiousddiseasedtestingdcandbedperformed.
b. theddegreedofdriskdfordcertaindareasdofdadhealthdcaredfacilitydtodexposuredtodi
nfectiousddiseases.
c. thedamountdofdventilationdrequireddindadtransfusiondservice.
d. howdmanydbiohazardousdwastedcontainersdadlaboratorydmustdhave.
ANS:d B
OSHAddefinesdbiosafetydlevelsdbaseddondpotentialdexposuredtodinfectiousdmaterial.
DIF: Leveld1
2. Adlaboratorydtechnologistddecideddshedwoulddlikedtodbringdherdlabdcoatdhomedfordlaunderingdbecauseditdha
wasdreturneddbydthedlaboratory’sdlaundrydservice.dIsdthisdpracticedacceptable?
a. Yes,difdshedusesd10%dbleach
b. Yes,difdshedclearsditdwithdherdsupervisor
c. Yes,dasdlongdasdshedremovesdthedcoatdandddoesdnotdwearditdhome
d. No,dbecausedthedlaboratorydisdadbiosafetydleveld2,danddlabdcoatsdmaydnotdbedr
emoved
ANS:d D
Methodsdofdtransportingdthedlabdcoatdanddthedriskdofdcontaminationddodnotdpermitdhealthdcaredworkersdtodb
DIF: Leveld2
3. Personaldprotectivedequipmentdincludes:
a. safetydglasses.
b. splashdbarriers.
c. masks.
d. Alldofdthedabove
ANS:d D
Safetydglasses,dsplashdbarriers,danddmasksdaredtypesdofdpersonaldprotectiveddevices.
DIF: Leveld1
4. Atdwhatdpointdindthedemploymentdprocessdshoulddsafetydtrainingdtakedplace?
a. Duringdorientationdanddtraining
b. Followingdlabdtrainingdwhendemployeesdaredmoredfamiliardwithdtheirdr
esponsibilities
c. Followingdthedemployees’dfirstdevaluation
d. Beforedindependentdworkdisdpermitteddanddannuallydthereafter
ANS:d D
ThedOccupationdSafetydanddHealthdAdministrationdrequiresdsafetydtrainingdbeforedindependentdworkdisdpe
ter.
DIF: Leveld1
5. Indsafetydtraining,demployeesdmustdbecomedfamiliardwithdalldofdthedfollowingdexcept:
a. tasksdthatdhavedandinfectiousdrisk.
b. limitsdofdprotectivedclothingdanddequipment.
c. thedappropriatedactiondtodtakedifdexposuredoccurs.
d. howdtodperformdcardiopulmonarydresuscitationdondaddonordordotherdemployee.
, 7. Whichdofdthedfollowingdisdtruedregardingdgooddmanufacturingdpracticesd(GMPs)?
a. GMPsdaredlegaldrequirementsdestablisheddbydthedFooddanddDrugdAdministration.
b. GMPsdaredoptionaldguidelinesdwrittendbydthedAABB.
c. GMPsdaredrequireddonlydbydpharmaceuticaldcompanies.
d. GMPsdaredpartdofdthedqualitydcontroldrequirementsdfordblooddproducts.
ANS:d A
GooddmanufacturingdpracticesdaredrequirementsdestablisheddbydthedFooddanddDrugdAdministration.
DIF: Leveld1
8. Whichdofdthedfollowingdisdandexampledofdandunacceptabledrecord-keepingdprocedure?
a. Usingddittosdindcolumnsdtodsavedtime
b. Recordingdtheddatedanddinitialsdnextdtodadcorrection
c. Notddeletingdthedoriginaldentrydwhendmakingdadcorrection
d. Alwaysdusingdpermanentdinkdondalldrecords
ANS:d A
Alldrecordsdmustdbedclearlydwritten.dDittosdaredunacceptable.
DIF: Leveld1
9. Adtechnologistdindtrainingdnoticeddthatdthedpersondtrainingdherdhaddnotdrecordeddthedresultsdofdadtest.dTodbe
cordeddthedresultsdshedsawdatdadlaterdtime,dusingdthedtechnologist’sdinitials.dIsdthisdandacceptabledprocedure
a. Yes;dalldresultsdmustdbedrecordeddregardlessdofdwhoddiddthedtest.
b. No;dshedshoulddhavedbroughtdthederrordtodthedtechnologist’sdattention.
c. Yes;dbecausedsheduseddthedotherdtechnologist’sdinitials.
d. Yes;dasdlongdasdshedrecordsdthedresultdindpencil.
ANS:d B
Thisdisdandexampledofdpoordrecorddkeeping;dresultsdmustdbedrecordeddwhendthedtestdisdperformeddanddbydth
DIF: Leveld3
10. Unacceptabledqualitydcontroldresultsdfordthedantiglobulindtestdperformeddindtestdtubesdmaydbednoticeddif:
a. preventivedmaintenancedhasdnotdbeendperformeddondthedcelldwasher.
b. thedtechnologistdperformingdthedtestdwasdneverdtrained.
c. thedreagentsduseddweredimproperlydstored.
d. Alldofdthedabove
ANS:d D
Training,dequipmentdmaintenance,danddreagentdqualitydcandaffectdqualitydcontrol.
DIF: Leveld2
11. Alldofdthedfollowingdaredtruedregardingdcompetencydtestingd except:
a. itdmustdbedperformeddfollowingdtraining.
b. itdmustdbedperformeddondandannualdbasis.
c. itdisdrequireddonlydifdthedtechnologistdhasdnodexperience.
d. retrainingdisdrequireddifdtheredisdadfailuredindcompetencydtesting.
ANS:d C
Alldemployeesdmustdhavedcompetencydtestingdfollowingdtrainingdanddannuallydthereafter.dIfdtheredisdadfailu
ingdisdrequired.
DIF: Leveld2
12. Whichdofdthedfollowingdorganizationsdaredinvolveddindthedregulationdofdblooddbanks?
a. ThedJointdCommission
b. AABB
c. CollegedofdAmericandPathologists
, 14. Thedstandarddoperatingdproceduredisdaddocumentdthat:
a. helpsdachievedconsistencydofdresults.
b. maydbedsubstituteddwithdpackagedinserts.
c. isdnecessarydonlydfordtrainingdnewdemployees.
d. mustdbedveryddetaileddtodbedaccurate.
ANS:d A
Standarddoperatingdproceduresdaredwrittendproceduresdthatdhelpdachievedconsistencydanddshoulddbedcleard
DIF: Leveld2
15. Employeedtrainingdtakesdplace:
a. afterdhiringdanddfollowingdimplementationdofdnewdprocedures.
b. followingdcompetencydassessment.
c. onlydfordnewdinexperienceddemployees.
d. asdproceduresdaredvalidated.
ANS:d A
Trainingdoccursdwithdalldnewdemployeesdregardlessdofdtheirdexperiencedanddfollowingdimplementationdof
DIF: Leveld1
16. Plansdthatdprovidedthedframeworkdfordestablishingdqualitydassurancedindandorganizationdare:
a. currentdgooddmanufacturingdpractices.
b. standarddoperatingdprocedures.
c. changedcontroldplan.
d. continuousdqualitydimprovementdplan.
ANS:d D
Thedtotaldqualitydmanagementdordcontinuousdqualitydimprovementdplandaredpartdofdthedqualitydassurancedp
DIF: Leveld1
17. Adfacilityddoesdnotdvalidatedadrefrigeratordbeforeduse.dWhatdisdadpotentialdoutcome?
a. Thedfacilitydisdindviolationdofdcurrentdgooddmanufacturingdpracticesdanddcoulddbedc
iteddbydthedFooddanddDrugdAdministration.
b. Thedfacilitydisdindcompliancedifdthedequipmentdfunctionsdproperly.
c. Thedfacilitydisdindcompliancedifdthedblooddproductsdstoreddinditdarednotdtransfused.
d. ThedfacilitydisdindviolationdofdAABBdanddmaydnodlongerdbedmembers.
ANS:d A
Validationdofdequipmentdisdadcurrentdgooddmanufacturingdpractice,dwhichdisdadlegaldrequirementdestablish
stration.
DIF: Leveld2
MULTIPLEdRESPONSE
1. Indadroutinedauditdofdadfacilitiesdblooddcollectiondarea,dthedqualitydassuranceddepartmentdfounddthatdthedblo
articularddaydhaddexpired.dWhatdisdthedappropriatedcoursedofdaction?d(Selectdalldthatdapply.)
a. Initiatedadrootdcausedanalysisdanddquarantinedthedblooddcollecteddindthedexpireddb
ags.
b. NotifydthedFDAdsincedthedexpireddbagsdwereddistributed.
c. Changedthedexpirationddatedondthedbagsdtodavoiddlegaldissues.
d. Firedtheddonordroomdsupervisor,dandddiscarddthedblooddcollecteddindthedexpireddb
ags.
ANS:d A,dB
Adrootdcausedanalysisdwillddeterminedthedfactorsdthatdcontributeddtodthederrordanddresultdindadplandtodpreven
DIF: Leveld3
BASICd&dAPPLIEDdCONCEPTSdOFdBLOODdBANKINGdANDdTRANSFUSIONdPRAC
TICESd5THdEDITION
Paula R. Howard
d d
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Bl
d d d d d d d d d d d d d d d
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
d d d d d d d d d d d
MULTIPLEdCHOICE
1. Biosafetydlevelsddetermine:
a. ondwhatdfloordcertaindinfectiousddiseasedtestingdcandbedperformed.
b. theddegreedofdriskdfordcertaindareasdofdadhealthdcaredfacilitydtodexposuredtodi
nfectiousddiseases.
c. thedamountdofdventilationdrequireddindadtransfusiondservice.
d. howdmanydbiohazardousdwastedcontainersdadlaboratorydmustdhave.
ANS:d B
OSHAddefinesdbiosafetydlevelsdbaseddondpotentialdexposuredtodinfectiousdmaterial.
DIF: Leveld1
2. Adlaboratorydtechnologistddecideddshedwoulddlikedtodbringdherdlabdcoatdhomedfordlaunderingdbecauseditdha
wasdreturneddbydthedlaboratory’sdlaundrydservice.dIsdthisdpracticedacceptable?
a. Yes,difdshedusesd10%dbleach
b. Yes,difdshedclearsditdwithdherdsupervisor
c. Yes,dasdlongdasdshedremovesdthedcoatdandddoesdnotdwearditdhome
d. No,dbecausedthedlaboratorydisdadbiosafetydleveld2,danddlabdcoatsdmaydnotdbedr
emoved
ANS:d D
Methodsdofdtransportingdthedlabdcoatdanddthedriskdofdcontaminationddodnotdpermitdhealthdcaredworkersdtodb
DIF: Leveld2
3. Personaldprotectivedequipmentdincludes:
a. safetydglasses.
b. splashdbarriers.
c. masks.
d. Alldofdthedabove
ANS:d D
Safetydglasses,dsplashdbarriers,danddmasksdaredtypesdofdpersonaldprotectiveddevices.
DIF: Leveld1
4. Atdwhatdpointdindthedemploymentdprocessdshoulddsafetydtrainingdtakedplace?
a. Duringdorientationdanddtraining
b. Followingdlabdtrainingdwhendemployeesdaredmoredfamiliardwithdtheirdr
esponsibilities
c. Followingdthedemployees’dfirstdevaluation
d. Beforedindependentdworkdisdpermitteddanddannuallydthereafter
ANS:d D
ThedOccupationdSafetydanddHealthdAdministrationdrequiresdsafetydtrainingdbeforedindependentdworkdisdpe
ter.
DIF: Leveld1
5. Indsafetydtraining,demployeesdmustdbecomedfamiliardwithdalldofdthedfollowingdexcept:
a. tasksdthatdhavedandinfectiousdrisk.
b. limitsdofdprotectivedclothingdanddequipment.
c. thedappropriatedactiondtodtakedifdexposuredoccurs.
d. howdtodperformdcardiopulmonarydresuscitationdondaddonordordotherdemployee.
, 7. Whichdofdthedfollowingdisdtruedregardingdgooddmanufacturingdpracticesd(GMPs)?
a. GMPsdaredlegaldrequirementsdestablisheddbydthedFooddanddDrugdAdministration.
b. GMPsdaredoptionaldguidelinesdwrittendbydthedAABB.
c. GMPsdaredrequireddonlydbydpharmaceuticaldcompanies.
d. GMPsdaredpartdofdthedqualitydcontroldrequirementsdfordblooddproducts.
ANS:d A
GooddmanufacturingdpracticesdaredrequirementsdestablisheddbydthedFooddanddDrugdAdministration.
DIF: Leveld1
8. Whichdofdthedfollowingdisdandexampledofdandunacceptabledrecord-keepingdprocedure?
a. Usingddittosdindcolumnsdtodsavedtime
b. Recordingdtheddatedanddinitialsdnextdtodadcorrection
c. Notddeletingdthedoriginaldentrydwhendmakingdadcorrection
d. Alwaysdusingdpermanentdinkdondalldrecords
ANS:d A
Alldrecordsdmustdbedclearlydwritten.dDittosdaredunacceptable.
DIF: Leveld1
9. Adtechnologistdindtrainingdnoticeddthatdthedpersondtrainingdherdhaddnotdrecordeddthedresultsdofdadtest.dTodbe
cordeddthedresultsdshedsawdatdadlaterdtime,dusingdthedtechnologist’sdinitials.dIsdthisdandacceptabledprocedure
a. Yes;dalldresultsdmustdbedrecordeddregardlessdofdwhoddiddthedtest.
b. No;dshedshoulddhavedbroughtdthederrordtodthedtechnologist’sdattention.
c. Yes;dbecausedsheduseddthedotherdtechnologist’sdinitials.
d. Yes;dasdlongdasdshedrecordsdthedresultdindpencil.
ANS:d B
Thisdisdandexampledofdpoordrecorddkeeping;dresultsdmustdbedrecordeddwhendthedtestdisdperformeddanddbydth
DIF: Leveld3
10. Unacceptabledqualitydcontroldresultsdfordthedantiglobulindtestdperformeddindtestdtubesdmaydbednoticeddif:
a. preventivedmaintenancedhasdnotdbeendperformeddondthedcelldwasher.
b. thedtechnologistdperformingdthedtestdwasdneverdtrained.
c. thedreagentsduseddweredimproperlydstored.
d. Alldofdthedabove
ANS:d D
Training,dequipmentdmaintenance,danddreagentdqualitydcandaffectdqualitydcontrol.
DIF: Leveld2
11. Alldofdthedfollowingdaredtruedregardingdcompetencydtestingd except:
a. itdmustdbedperformeddfollowingdtraining.
b. itdmustdbedperformeddondandannualdbasis.
c. itdisdrequireddonlydifdthedtechnologistdhasdnodexperience.
d. retrainingdisdrequireddifdtheredisdadfailuredindcompetencydtesting.
ANS:d C
Alldemployeesdmustdhavedcompetencydtestingdfollowingdtrainingdanddannuallydthereafter.dIfdtheredisdadfailu
ingdisdrequired.
DIF: Leveld2
12. Whichdofdthedfollowingdorganizationsdaredinvolveddindthedregulationdofdblooddbanks?
a. ThedJointdCommission
b. AABB
c. CollegedofdAmericandPathologists
, 14. Thedstandarddoperatingdproceduredisdaddocumentdthat:
a. helpsdachievedconsistencydofdresults.
b. maydbedsubstituteddwithdpackagedinserts.
c. isdnecessarydonlydfordtrainingdnewdemployees.
d. mustdbedveryddetaileddtodbedaccurate.
ANS:d A
Standarddoperatingdproceduresdaredwrittendproceduresdthatdhelpdachievedconsistencydanddshoulddbedcleard
DIF: Leveld2
15. Employeedtrainingdtakesdplace:
a. afterdhiringdanddfollowingdimplementationdofdnewdprocedures.
b. followingdcompetencydassessment.
c. onlydfordnewdinexperienceddemployees.
d. asdproceduresdaredvalidated.
ANS:d A
Trainingdoccursdwithdalldnewdemployeesdregardlessdofdtheirdexperiencedanddfollowingdimplementationdof
DIF: Leveld1
16. Plansdthatdprovidedthedframeworkdfordestablishingdqualitydassurancedindandorganizationdare:
a. currentdgooddmanufacturingdpractices.
b. standarddoperatingdprocedures.
c. changedcontroldplan.
d. continuousdqualitydimprovementdplan.
ANS:d D
Thedtotaldqualitydmanagementdordcontinuousdqualitydimprovementdplandaredpartdofdthedqualitydassurancedp
DIF: Leveld1
17. Adfacilityddoesdnotdvalidatedadrefrigeratordbeforeduse.dWhatdisdadpotentialdoutcome?
a. Thedfacilitydisdindviolationdofdcurrentdgooddmanufacturingdpracticesdanddcoulddbedc
iteddbydthedFooddanddDrugdAdministration.
b. Thedfacilitydisdindcompliancedifdthedequipmentdfunctionsdproperly.
c. Thedfacilitydisdindcompliancedifdthedblooddproductsdstoreddinditdarednotdtransfused.
d. ThedfacilitydisdindviolationdofdAABBdanddmaydnodlongerdbedmembers.
ANS:d A
Validationdofdequipmentdisdadcurrentdgooddmanufacturingdpractice,dwhichdisdadlegaldrequirementdestablish
stration.
DIF: Leveld2
MULTIPLEdRESPONSE
1. Indadroutinedauditdofdadfacilitiesdblooddcollectiondarea,dthedqualitydassuranceddepartmentdfounddthatdthedblo
articularddaydhaddexpired.dWhatdisdthedappropriatedcoursedofdaction?d(Selectdalldthatdapply.)
a. Initiatedadrootdcausedanalysisdanddquarantinedthedblooddcollecteddindthedexpireddb
ags.
b. NotifydthedFDAdsincedthedexpireddbagsdwereddistributed.
c. Changedthedexpirationddatedondthedbagsdtodavoiddlegaldissues.
d. Firedtheddonordroomdsupervisor,dandddiscarddthedblooddcollecteddindthedexpireddb
ags.
ANS:d A,dB
Adrootdcausedanalysisdwillddeterminedthedfactorsdthatdcontributeddtodthederrordanddresultdindadplandtodpreven
DIF: Leveld3
