Test Bank For Basic & Applied Concepts of Blood Banking and Transfusion Practices 5th Edition

TESTBANK f




BASICf&fAPPLIEDfCONCEPTSfOFfBLOODfBANKINGfANDfTRANSFUSIONfPRACT
ICESf5THfEDITION

Paula R. Howard
f f

, Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank Howard: Bas
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ic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
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MULTIPLEfCHOICE

1. Biosafetyflevelsfdetermine:
a. onfwhatffloorfcertainfinfectiousfdiseaseftestingfcanfbefperformed.
b. thefdegreefoffriskfforfcertainfareasfoffafhealthfcareffacilityftofexposureftofinfe
ctiousfdiseases.
c. thefamountfoffventilationfrequiredfinfaftransfusionfservice.
d. howfmanyfbiohazardousfwastefcontainersfaflaboratoryfmustfhave.
ANS:f B
OSHAfdefinesfbiosafetyflevelsfbasedfonfpotentialfexposureftofinfectiousfmaterial.

DIF: Levelf1

2. Aflaboratoryftechnologistfdecidedfshefwouldflikeftofbringfherflabfcoatfhomefforflaunderingfbecausefitfhadftoofmanyfwrinklesfwhenfitfwas
returnedfbyftheflaboratory’sflaundryfservice.fIsfthisfpracticefacceptable?
f

a. Yes,fiffshefusesf10%fbleach
b. Yes,fiffshefclearsfitfwithfherfsupervisor
c. Yes,fasflongfasfshefremovesfthefcoatfandfdoesfnotfwearfitfhome
d. No,fbecauseftheflaboratoryfisfafbiosafetyflevelf2,fandflabfcoatsfmayfnotfbefrem
oved
ANS:f D
Methodsfofftransportingftheflabfcoatfandfthefriskfoffcontaminationfdofnotfpermitfhealthfcarefworkersftofbringflabfcoatsfhomefforfcleaning.

DIF: Levelf2

3. Personalfprotectivefequipmentfincludes:
a. safetyfglasses.
b. splashfbarriers.
c. masks.
d. Allfoffthefabove
ANS:f D
Safetyfglasses,fsplashfbarriers,fandfmasksfareftypesfoffpersonalfprotectivefdevices.

DIF: Levelf1

4. Atfwhatfpointfinfthefemploymentfprocessfshouldfsafetyftrainingftakefplace?
a. Duringforientationfandftraining
b. Followingflabftrainingfwhenfemployeesfarefmoreffamiliarfwithftheirfre
sponsibilities
c. Followingfthefemployees’ffirstfevaluation
d. Beforefindependentfworkfisfpermittedfandfannuallyfthereafter
ANS:f D
ThefOccupationfSafetyfandfHealthfAdministrationfrequiresfsafetyftrainingfbeforefindependentfworkfisfpermittedfandfannuallyfthereafter.

DIF: Levelf1

5. Infsafetyftraining,femployeesfmustfbecomeffamiliarfwithfallfofftheffollowingfexcept:
a. tasksfthatfhavefanfinfectiousfrisk.
b. limitsfoffprotectivefclothingfandfequipment.
c. thefappropriatefactionftoftakefiffexposurefoccurs.
d. howftofperformfcardiopulmonaryfresuscitationfonfafdonorforfotherfemployee.
ANS:f D
ThefOccupationalfSafetyfandfHealthfAdministrationfrequirementsfincludefallfoffthoseflistedfexceptfcardiopulmonaryfresuscitation.

DIF: Levelf1

6. Bloodfirradiatorsfrequirefallfofftheffollowingfsafetyfproceduresf except:
a. properftraining.
b. thatfthefuserfhavefafdegreefinfradiology.
c. equipmentfleakfdetection.
d. personalfprotectivefequipment.
ANS:f B
Bloodfbankfandftransfusionfserviceftechnologistsfrequireftrainingfbutfnotfafdegreeftofusefafbloodfirradiator.

DIF: Levelf2




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, 7. Whichfofftheffollowingfisftruefregardingfgoodfmanufacturingfpracticesf(GMPs)?
a. GMPsfareflegalfrequirementsfestablishedfbyfthefFoodfandfDrugfAdministration.
b. GMPsfarefoptionalfguidelinesfwrittenfbyfthefAABB.
c. GMPsfarefrequiredfonlyfbyfpharmaceuticalfcompanies.
d. GMPsfarefpartfoffthefqualityfcontrolfrequirementsfforfbloodfproducts.
ANS:f A
GoodfmanufacturingfpracticesfarefrequirementsfestablishedfbyfthefFoodfandfDrugfAdministration.

DIF: Levelf1

8. Whichfofftheffollowingfisfanfexamplefoffanfunacceptablefrecord-keepingfprocedure?
a. Usingfdittosfinfcolumnsftofsaveftime
b. Recordingfthefdatefandfinitialsfnextftofafcorrection
c. Notfdeletingftheforiginalfentryfwhenfmakingfafcorrection
d. Alwaysfusingfpermanentfinkfonfallfrecords
ANS:f A
Allfrecordsfmustfbefclearlyfwritten.fDittosfarefunacceptable.

DIF: Levelf1

9. Aftechnologistfinftrainingfnoticedfthatfthefpersonftrainingfherfhadfnotfrecordedfthefresultsfoffaftest.fTofbefhelpful,fshefcarefullyfrecor
dedfthefresultsfshefsawfatfaflaterftime,fusingftheftechnologist’sfinitials.fIsfthisfanfacceptablefprocedure?
a. Yes;fallfresultsfmustfbefrecordedfregardlessfoffwhofdidftheftest.
b. No;fshefshouldfhavefbroughtftheferrorftoftheftechnologist’sfattention.
c. Yes;fbecausefshefusedfthefotherftechnologist’sfinitials.
d. Yes;fasflongfasfshefrecordsfthefresultfinfpencil.
ANS:f B
Thisfisfanfexamplefoffpoorfrecordfkeeping;fresultsfmustfbefrecordedfwhenftheftestfisfperformedfandfbyfthefpersonfdoingftheftest.

DIF: Levelf3

10. Unacceptablefqualityfcontrolfresultsfforfthefantiglobulinftestfperformedfinftestftubesfmayfbefnoticedfif:
a. preventivefmaintenancefhasfnotfbeenfperformedfonfthefcellfwasher.
b. theftechnologistfperformingftheftestfwasfneverftrained.
c. thefreagentsfusedfwerefimproperlyfstored.
d. Allfoffthefabove
ANS:f D
Training,fequipmentfmaintenance,fandfreagentfqualityfcanfaffectfqualityfcontrol.

DIF: Levelf2

11. Allfofftheffollowingfareftruefregardingfcompetencyftestingf except:
a. itfmustfbefperformedffollowingftraining.
b. itfmustfbefperformedfonfanfannualfbasis.
c. itfisfrequiredfonlyfifftheftechnologistfhasfnofexperience.
d. retrainingfisfrequiredfifftherefisfaffailurefinfcompetencyftesting.
ANS:f C
Allfemployeesfmustfhavefcompetencyftestingffollowingftrainingfandfannuallyfthereafter.fIfftherefisfaffailurefinfcompetencyftesting,fretrainingf
isfrequired.

DIF: Levelf2

12. Whichfofftheffollowingforganizationsfarefinvolvedfinfthefregulationfoffbloodfbanks?
a. ThefJointfCommission
b. AABB
c. CollegefoffAmericanfPathologists
d. FoodfandfDrugfAdministration
ANS:f D
ThefFoodfandfDrugfAdministrationfregulatesfbloodfbanks,fwhereasfthefotherforganizationsfarefinvolvedfinfaccreditation.

DIF: Levelf1

13. Allfofftheffollowingfarefresponsibilitiesfoffthefqualityfassurancefdepartmentfoffafbloodfbankf except:
a. performingfinternalfaudits.
b. performingfqualityfcontrol.
c. reviewingfstandardfoperatingfprocedures.
d. reviewingfandfapprovingftrainingfprograms.
ANS:f B
Qualityfcontrolfisfperformedfinftheflaboratory,fnotfbyfthefqualityfassurancefdepartment.

DIF: Levelf2




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, 14. Thefstandardfoperatingfprocedurefisfafdocumentfthat:
a. helpsfachievefconsistencyfoffresults.
b. mayfbefsubstitutedfwithfpackagefinserts.
c. isfnecessaryfonlyfforftrainingfnewfemployees.
d. mustfbefveryfdetailedftofbefaccurate.
ANS:f A
Standardfoperatingfproceduresfarefwrittenfproceduresfthatfhelpfachievefconsistencyfandfshouldfbefclearfandfconcise.

DIF: Levelf2

15. Employeeftrainingftakesfplace:
a. afterfhiringfandffollowingfimplementationfoffnewfprocedures.
b. followingfcompetencyfassessment.
c. onlyfforfnewfinexperiencedfemployees.
d. asfproceduresfarefvalidated.
ANS:f A
Trainingfoccursfwithfallfnewfemployeesfregardlessfofftheirfexperiencefandffollowingfimplementationfoffnewfprocedures.

DIF: Levelf1

16. Plansfthatfprovidefthefframeworkfforfestablishingfqualityfassurancefinfanforganizationfare:
a. currentfgoodfmanufacturingfpractices.
b. standardfoperatingfprocedures.
c. changefcontrolfplan.
d. continuousfqualityfimprovementfplan.
ANS:f D
Theftotalfqualityfmanagementforfcontinuousfqualityfimprovementfplanfarefpartfoffthefqualityfassurancefprogramfinfanforganization.

DIF: Levelf1

17. Affacilityfdoesfnotfvalidatefafrefrigeratorfbeforefuse.fWhatfisfafpotentialfoutcome?
a. Theffacilityfisfinfviolationfoffcurrentfgoodfmanufacturingfpracticesfandfcouldfbefcit
edfbyfthefFoodfandfDrugfAdministration.
b. Theffacilityfisfinfcompliancefiffthefequipmentffunctionsfproperly.
c. Theffacilityfisfinfcompliancefiffthefbloodfproductsfstoredfinfitfarefnotftransfused.
d. TheffacilityfisfinfviolationfoffAABBfandfmayfnoflongerfbefmembers.
ANS:f A
Validationfoffequipmentfisfafcurrentfgoodfmanufacturingfpractice,fwhichfisfaflegalfrequirementfestablishedfbyfthefFoodfandfDrugfAdministrat
ion.

DIF: Levelf2


MULTIPLEfRESPONSE

1. Infafroutinefauditfoffaffacilitiesfbloodfcollectionfarea,fthefqualityfassurancefdepartmentffoundfthatfthefbloodfbagsfusedfonfthatfpartic
ularfdayfhadfexpired.fWhatfisfthefappropriatefcoursefoffaction?f(Selectfallfthatfapply.)
a. Initiatefafrootfcausefanalysisfandfquarantinefthefbloodfcollectedfinfthefexpiredfba
gs.
b. NotifyfthefFDAfsincefthefexpiredfbagsfwerefdistributed.
c. Changefthefexpirationfdatefonfthefbagsftofavoidflegalfissues.
d. Firefthefdonorfroomfsupervisor,fandfdiscardfthefbloodfcollectedfinfthefexpiredfba
gs.
ANS:f A,fB
Afrootfcausefanalysisfwillfdetermineftheffactorsfthatfcontributedftoftheferrorfandfresultfinfafplanftofpreventffurtherferrors.

DIF: Levelf3

2. Severalfunitsfwerefreleasedftofafhospitalfbyfmistakefbeforefallfviralfmarkerftestingfwasfcompleted.fWhatfisfthefappropriatefcoursefoffact
ion?f(Selectfallfthatfapply.)
a. Theferrorfisfreportable,fandfthefFoodfandfDrugfAdministrationfmustfbefcontacted.
b. Callfthefhospitalfandfrequestfafquarantinefoffthefremainingfproductsfinfinventory.
c. Performfafrootfcausefanalysisfand,fiffthefunitsfareffoundftofbefnegative,freportftheftestf
resultftofthefhospital.
d. Recallfonlyfthefunitsfthatfarefpositivefforfviralfmarkers.
ANS:f A,fB
ReleasefoffuntestedfunitsfisfafreportableferrorftofthefFoodfandfDrugfAdministrationfandfthefhospitalfmustfbefnotifiedftofquarantinefanyfre
mainingfproductsfpendingfcompletionfofftestfresults.

DIF: Levelf3




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