TESTBANK i
BASIC i& iAPPLIED iCONCEPTS iOF iBLOOD iBANKING iAND iTRANSFUSION
iPRACTICES i5TH iEDITION
Paula R. Howard
i i
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the
i i i i i i i i i i i i i i
Howard: Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
i i i i i i i i i i i i i
MULTIPLE iCHOICE
1. Biosafety ilevels idetermine:
a. on iwhat ifloor icertain iinfectious idisease itesting ican ibe iperformed.
b. the idegree iof irisk ifor icertain iareas iof ia ihealth icare ifacility ito iexposure
to iinfectious idiseases.
i
c. the iamount iof iventilation irequired iin ia itransfusion iservice.
d. how imany ibiohazardous iwaste icontainers ia ilaboratory imust ihave.
ANS: i B
OSHA idefines ibiosafety ilevels ibased ion ipotential iexposure ito iinfectious imaterial.
DIF: Level i1
2. A ilaboratory itechnologist idecided ishe iwould ilike ito ibring iher ilab icoat ihome ifor ilaundering ibecause i
i when iit iwas ireturned iby ithe ilaboratory’s ilaundry iservice. iIs ithis ipractice iacceptable?
a. Yes, iif ishe iuses i10% ibleach
b. Yes, iif ishe iclears iit iwith iher isupervisor
c. Yes, ias ilong ias ishe iremoves ithe icoat iand idoes inot iwear iit ihome
d. No, ibecause ithe ilaboratory iis ia ibiosafety ilevel i2, iand ilab icoats imay inot
ibe iremoved
ANS: i D
Methods iof itransporting ithe ilab icoat iand ithe irisk iof icontamination ido inot ipermit ihealth icare iworkers
icleaning.
DIF: Level i2
3. Personal iprotective iequipment iincludes:
a. safety iglasses.
b. splash ibarriers.
c. masks.
d. All iof ithe iabove
ANS: i D
Safety iglasses, isplash ibarriers, iand imasks iare itypes iof ipersonal iprotective idevices.
DIF: Level i1
4. At iwhat ipoint iin ithe iemployment iprocess ishould isafety itraining itake iplace?
a. During iorientation iand itraining
b. Following ilab itraining iwhen iemployees iare imore ifamiliar iwith
their iresponsibilities
i
c. Following ithe iemployees’ ifirst ievaluation
d. Before iindependent iwork iis ipermitted iand iannually ithereafter
ANS: i D
The iOccupation iSafety iand iHealth iAdministration irequires isafety itraining ibefore iindependent iwork iis
ithereafter.
DIF: Level i1
5. In isafety itraining, iemployees imust ibecome ifamiliar iwith iall iof ithe ifollowing iexcept:
a. tasks ithat ihave ian iinfectious irisk.
b. limits iof iprotective iclothing iand iequipment.
c. the iappropriate iaction ito itake iif iexposure ioccurs.
, 7. Which iof ithe ifollowing iis itrue iregarding igood imanufacturing ipractices i(GMPs)?
a. GMPs iare ilegal irequirements iestablished iby ithe iFood iand iDrug iAdministration.
b. GMPs iare ioptional iguidelines iwritten iby ithe iAABB.
c. GMPs iare irequired ionly iby ipharmaceutical icompanies.
d. GMPs iare ipart iof ithe iquality icontrol irequirements ifor iblood iproducts.
ANS: i A
Good imanufacturing ipractices iare irequirements iestablished iby ithe iFood iand iDrug iAdministration.
DIF: Level i1
8. Which iof ithe ifollowing iis ian iexample iof ian iunacceptable irecord-keeping iprocedure?
a. Using idittos iin icolumns ito isave itime
b. Recording ithe idate iand iinitials inext ito ia icorrection
c. Not ideleting ithe ioriginal ientry iwhen imaking ia icorrection
d. Always iusing ipermanent iink ion iall irecords
ANS: i A
All irecords imust ibe iclearly iwritten. iDittos iare iunacceptable.
DIF: Level i1
9. A itechnologist iin itraining inoticed ithat ithe iperson itraining iher ihad inot irecorded ithe iresults iof ia itest. iT
carefully irecorded ithe iresults ishe isaw iat ia ilater itime, iusing ithe itechnologist’s iinitials. iIs ithis ian iacce
i
a. Yes; iall iresults imust ibe irecorded iregardless iof iwho idid ithe itest.
b. No; ishe ishould ihave ibrought ithe ierror ito ithe itechnologist’s iattention.
c. Yes; ibecause ishe iused ithe iother itechnologist’s iinitials.
d. Yes; ias ilong ias ishe irecords ithe iresult iin ipencil.
ANS: i B
This iis ian iexample iof ipoor irecord ikeeping; iresults imust ibe irecorded iwhen ithe itest iis iperformed iand
DIF: Level i3
10. Unacceptable iquality icontrol iresults ifor ithe iantiglobulin itest iperformed iin itest itubes imay ibe inoticed
a. preventive imaintenance ihas inot ibeen iperformed ion ithe icell iwasher.
b. the itechnologist iperforming ithe itest iwas inever itrained.
c. the ireagents iused iwere iimproperly istored.
d. All iof ithe iabove
ANS: i D
Training, iequipment imaintenance, iand ireagent iquality ican iaffect iquality icontrol.
DIF: Level i2
11. All iof ithe ifollowing iare itrue iregarding icompetency itesting iexcept:
a. it imust ibe iperformed ifollowing itraining.
b. it imust ibe iperformed ion ian iannual ibasis.
c. it iis irequired ionly iif ithe itechnologist ihas ino iexperience.
d. retraining iis irequired iif ithere iis ia ifailure iin icompetency itesting.
ANS: i C
All iemployees imust ihave icompetency itesting ifollowing itraining iand iannually ithereafter. iIf ithere iis ia
iretraining iis irequired.
DIF: Level i2
12. Which iof ithe ifollowing iorganizations iare iinvolved iin ithe iregulation iof iblood ibanks?
a. The iJoint iCommission
b. AABB
c. College iof iAmerican iPathologists
, 14. The istandard ioperating iprocedure iis ia idocument ithat:
a. helps iachieve iconsistency iof iresults.
b. may ibe isubstituted iwith ipackage iinserts.
c. is inecessary ionly ifor itraining inew iemployees.
d. must ibe ivery idetailed ito ibe iaccurate.
ANS: i A
Standard ioperating iprocedures iare iwritten iprocedures ithat ihelp iachieve iconsistency iand ishould ibe icl
DIF: Level i2
15. Employee itraining itakes iplace:
a. after ihiring iand ifollowing iimplementation iof inew iprocedures.
b. following icompetency iassessment.
c. only ifor inew iinexperienced iemployees.
d. as iprocedures iare ivalidated.
ANS: i A
Training ioccurs iwith iall inew iemployees iregardless iof itheir iexperience iand ifollowing iimplementation
DIF: Level i1
16. Plans ithat iprovide ithe iframework ifor iestablishing iquality iassurance iin ian iorganization iare:
a. current igood imanufacturing ipractices.
b. standard ioperating iprocedures.
c. change icontrol iplan.
d. continuous iquality iimprovement iplan.
ANS: i D
The itotal iquality imanagement ior icontinuous iquality iimprovement iplan iare ipart iof ithe iquality iassuran
iorganization.
DIF: Level i1
17. A ifacility idoes inot ivalidate ia irefrigerator ibefore iuse. iWhat iis ia ipotential ioutcome?
a. The ifacility iis iin iviolation iof icurrent igood imanufacturing ipractices iand icould
be icited iby ithe iFood iand iDrug iAdministration.
i
b. The ifacility iis iin icompliance iif ithe iequipment ifunctions iproperly.
c. The ifacility iis iin icompliance iif ithe iblood iproducts istored iin iit iare inot itransfused.
d. The ifacility iis iin iviolation iof iAABB iand imay ino ilonger ibe imembers.
ANS: i A
Validation iof iequipment iis ia icurrent igood imanufacturing ipractice, iwhich iis ia ilegal irequirement iestab
iAdministration.
DIF: Level i2
MULTIPLE iRESPONSE
1. In ia iroutine iaudit iof ia ifacilities iblood icollection iarea, ithe iquality iassurance idepartment ifound ithat ithe
that iparticular iday ihad iexpired. iWhat iis ithe iappropriate icourse iof iaction? i(Select iall ithat iapply.)
i
a. Initiate ia iroot icause ianalysis iand iquarantine ithe iblood icollected iin ithe
iexpired ibags.
b. Notify ithe iFDA isince ithe iexpired ibags iwere idistributed.
c. Change ithe iexpiration idate ion ithe ibags ito iavoid ilegal iissues.
d. Fire ithe idonor iroom isupervisor, iand idiscard ithe iblood icollected iin ithe
iexpired ibags.
ANS: i A, iB
A iroot icause ianalysis iwill idetermine ithe ifactors ithat icontributed ito ithe ierror iand iresult iin ia iplan ito ip
BASIC i& iAPPLIED iCONCEPTS iOF iBLOOD iBANKING iAND iTRANSFUSION
iPRACTICES i5TH iEDITION
Paula R. Howard
i i
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the
i i i i i i i i i i i i i i
Howard: Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
i i i i i i i i i i i i i
MULTIPLE iCHOICE
1. Biosafety ilevels idetermine:
a. on iwhat ifloor icertain iinfectious idisease itesting ican ibe iperformed.
b. the idegree iof irisk ifor icertain iareas iof ia ihealth icare ifacility ito iexposure
to iinfectious idiseases.
i
c. the iamount iof iventilation irequired iin ia itransfusion iservice.
d. how imany ibiohazardous iwaste icontainers ia ilaboratory imust ihave.
ANS: i B
OSHA idefines ibiosafety ilevels ibased ion ipotential iexposure ito iinfectious imaterial.
DIF: Level i1
2. A ilaboratory itechnologist idecided ishe iwould ilike ito ibring iher ilab icoat ihome ifor ilaundering ibecause i
i when iit iwas ireturned iby ithe ilaboratory’s ilaundry iservice. iIs ithis ipractice iacceptable?
a. Yes, iif ishe iuses i10% ibleach
b. Yes, iif ishe iclears iit iwith iher isupervisor
c. Yes, ias ilong ias ishe iremoves ithe icoat iand idoes inot iwear iit ihome
d. No, ibecause ithe ilaboratory iis ia ibiosafety ilevel i2, iand ilab icoats imay inot
ibe iremoved
ANS: i D
Methods iof itransporting ithe ilab icoat iand ithe irisk iof icontamination ido inot ipermit ihealth icare iworkers
icleaning.
DIF: Level i2
3. Personal iprotective iequipment iincludes:
a. safety iglasses.
b. splash ibarriers.
c. masks.
d. All iof ithe iabove
ANS: i D
Safety iglasses, isplash ibarriers, iand imasks iare itypes iof ipersonal iprotective idevices.
DIF: Level i1
4. At iwhat ipoint iin ithe iemployment iprocess ishould isafety itraining itake iplace?
a. During iorientation iand itraining
b. Following ilab itraining iwhen iemployees iare imore ifamiliar iwith
their iresponsibilities
i
c. Following ithe iemployees’ ifirst ievaluation
d. Before iindependent iwork iis ipermitted iand iannually ithereafter
ANS: i D
The iOccupation iSafety iand iHealth iAdministration irequires isafety itraining ibefore iindependent iwork iis
ithereafter.
DIF: Level i1
5. In isafety itraining, iemployees imust ibecome ifamiliar iwith iall iof ithe ifollowing iexcept:
a. tasks ithat ihave ian iinfectious irisk.
b. limits iof iprotective iclothing iand iequipment.
c. the iappropriate iaction ito itake iif iexposure ioccurs.
, 7. Which iof ithe ifollowing iis itrue iregarding igood imanufacturing ipractices i(GMPs)?
a. GMPs iare ilegal irequirements iestablished iby ithe iFood iand iDrug iAdministration.
b. GMPs iare ioptional iguidelines iwritten iby ithe iAABB.
c. GMPs iare irequired ionly iby ipharmaceutical icompanies.
d. GMPs iare ipart iof ithe iquality icontrol irequirements ifor iblood iproducts.
ANS: i A
Good imanufacturing ipractices iare irequirements iestablished iby ithe iFood iand iDrug iAdministration.
DIF: Level i1
8. Which iof ithe ifollowing iis ian iexample iof ian iunacceptable irecord-keeping iprocedure?
a. Using idittos iin icolumns ito isave itime
b. Recording ithe idate iand iinitials inext ito ia icorrection
c. Not ideleting ithe ioriginal ientry iwhen imaking ia icorrection
d. Always iusing ipermanent iink ion iall irecords
ANS: i A
All irecords imust ibe iclearly iwritten. iDittos iare iunacceptable.
DIF: Level i1
9. A itechnologist iin itraining inoticed ithat ithe iperson itraining iher ihad inot irecorded ithe iresults iof ia itest. iT
carefully irecorded ithe iresults ishe isaw iat ia ilater itime, iusing ithe itechnologist’s iinitials. iIs ithis ian iacce
i
a. Yes; iall iresults imust ibe irecorded iregardless iof iwho idid ithe itest.
b. No; ishe ishould ihave ibrought ithe ierror ito ithe itechnologist’s iattention.
c. Yes; ibecause ishe iused ithe iother itechnologist’s iinitials.
d. Yes; ias ilong ias ishe irecords ithe iresult iin ipencil.
ANS: i B
This iis ian iexample iof ipoor irecord ikeeping; iresults imust ibe irecorded iwhen ithe itest iis iperformed iand
DIF: Level i3
10. Unacceptable iquality icontrol iresults ifor ithe iantiglobulin itest iperformed iin itest itubes imay ibe inoticed
a. preventive imaintenance ihas inot ibeen iperformed ion ithe icell iwasher.
b. the itechnologist iperforming ithe itest iwas inever itrained.
c. the ireagents iused iwere iimproperly istored.
d. All iof ithe iabove
ANS: i D
Training, iequipment imaintenance, iand ireagent iquality ican iaffect iquality icontrol.
DIF: Level i2
11. All iof ithe ifollowing iare itrue iregarding icompetency itesting iexcept:
a. it imust ibe iperformed ifollowing itraining.
b. it imust ibe iperformed ion ian iannual ibasis.
c. it iis irequired ionly iif ithe itechnologist ihas ino iexperience.
d. retraining iis irequired iif ithere iis ia ifailure iin icompetency itesting.
ANS: i C
All iemployees imust ihave icompetency itesting ifollowing itraining iand iannually ithereafter. iIf ithere iis ia
iretraining iis irequired.
DIF: Level i2
12. Which iof ithe ifollowing iorganizations iare iinvolved iin ithe iregulation iof iblood ibanks?
a. The iJoint iCommission
b. AABB
c. College iof iAmerican iPathologists
, 14. The istandard ioperating iprocedure iis ia idocument ithat:
a. helps iachieve iconsistency iof iresults.
b. may ibe isubstituted iwith ipackage iinserts.
c. is inecessary ionly ifor itraining inew iemployees.
d. must ibe ivery idetailed ito ibe iaccurate.
ANS: i A
Standard ioperating iprocedures iare iwritten iprocedures ithat ihelp iachieve iconsistency iand ishould ibe icl
DIF: Level i2
15. Employee itraining itakes iplace:
a. after ihiring iand ifollowing iimplementation iof inew iprocedures.
b. following icompetency iassessment.
c. only ifor inew iinexperienced iemployees.
d. as iprocedures iare ivalidated.
ANS: i A
Training ioccurs iwith iall inew iemployees iregardless iof itheir iexperience iand ifollowing iimplementation
DIF: Level i1
16. Plans ithat iprovide ithe iframework ifor iestablishing iquality iassurance iin ian iorganization iare:
a. current igood imanufacturing ipractices.
b. standard ioperating iprocedures.
c. change icontrol iplan.
d. continuous iquality iimprovement iplan.
ANS: i D
The itotal iquality imanagement ior icontinuous iquality iimprovement iplan iare ipart iof ithe iquality iassuran
iorganization.
DIF: Level i1
17. A ifacility idoes inot ivalidate ia irefrigerator ibefore iuse. iWhat iis ia ipotential ioutcome?
a. The ifacility iis iin iviolation iof icurrent igood imanufacturing ipractices iand icould
be icited iby ithe iFood iand iDrug iAdministration.
i
b. The ifacility iis iin icompliance iif ithe iequipment ifunctions iproperly.
c. The ifacility iis iin icompliance iif ithe iblood iproducts istored iin iit iare inot itransfused.
d. The ifacility iis iin iviolation iof iAABB iand imay ino ilonger ibe imembers.
ANS: i A
Validation iof iequipment iis ia icurrent igood imanufacturing ipractice, iwhich iis ia ilegal irequirement iestab
iAdministration.
DIF: Level i2
MULTIPLE iRESPONSE
1. In ia iroutine iaudit iof ia ifacilities iblood icollection iarea, ithe iquality iassurance idepartment ifound ithat ithe
that iparticular iday ihad iexpired. iWhat iis ithe iappropriate icourse iof iaction? i(Select iall ithat iapply.)
i
a. Initiate ia iroot icause ianalysis iand iquarantine ithe iblood icollected iin ithe
iexpired ibags.
b. Notify ithe iFDA isince ithe iexpired ibags iwere idistributed.
c. Change ithe iexpiration idate ion ithe ibags ito iavoid ilegal iissues.
d. Fire ithe idonor iroom isupervisor, iand idiscard ithe iblood icollected iin ithe
iexpired ibags.
ANS: i A, iB
A iroot icause ianalysis iwill idetermine ithe ifactors ithat icontributed ito ithe ierror iand iresult iin ia iplan ito ip
