TEST BANK for Basic and Applied Concepts of Blood Banking and Transfusion Practices 5th Edition By Paula Howard

ChapterX01:XQualityXAssuranceXandXRegulationXofXtheXBloodXIndustryXandXSafetyXIssuesXin
Howard:XBasicX&XAppliedXConceptsXofXBloodXBankingXandXTransfusionXPractices,X5thXEdi


MULTIPLEXCHOICE

1. BiosafetyXlevelsXdetermine:
a. onXwhatXfloorXcertainXinfectiousXdiseaseXtestingXcanXbeXperformed.
b. theXdegreeXofXriskXforXcertainXareasXofXaXhealthXcareXfacilityXtoXexp
osureXtoXinfectiousXdiseases.
c. theXamountXofXventilationXrequiredXinXaXtransfusionXservice.
d. howXmanyXbiohazardousXwasteXcontainersXaXlaboratoryXmustXhave.
ANS:X B
OSHAXdefinesXbiosafetyXlevelsXbasedXonXpotentialXexposureXtoXinfectiousXmaterial.

DIF: LevelX1

2. AXlaboratoryXtechnologistXdecidedXsheXwouldXlikeXtoXbringXherXlabXcoatXhomeXforXlaunderingXbec
nklesXwhenXitXwasXreturnedXbyXtheXlaboratory’sXlaundryXservice.XIsXthisXpracticeXacceptable?
a. Yes,XifXsheXusesX10%Xbleach
b. Yes,XifXsheXclearsXitXwithXherXsupervisor
c. Yes,XasXlongXasXsheXremovesXtheXcoatXandXdoesXnotXwearXitXhome
d. No,XbecauseXtheXlaboratoryXisXaXbiosafetyXlevelX2,XandXlabXcoatsXmay
XnotXbeXremoved

ANS:X D
MethodsXofXtransportingXtheXlabXcoatXandXtheXriskXofXcontaminationXdoXnotXpermitXhealthXcareXw
eXforXcleaning.

DIF: LevelX2

3. PersonalXprotectiveXequipmentXincludes:
a. safetyXglasses.
b. splashXbarriers.
c. masks.
d. AllXofXtheXabove
ANS:X D
SafetyXglasses,XsplashXbarriers,XandXmasksXareXtypesXofXpersonalXprotectiveXdevices.

DIF: LevelX1

4. AtXwhatXpointXinXtheXemploymentXprocessXshouldXsafetyXtrainingXtakeXplace?
a. DuringXorientationXandXtraining
b. FollowingXlabXtrainingXwhenXemployeesXareXmoreXfamiliarXwith
XtheirXresponsibilities
c. FollowingXtheXemployees’XfirstXevaluation
d. BeforeXindependentXworkXisXpermittedXandXannuallyXthereafter
ANS:X D
TheXOccupationXSafetyXandXHealthXAdministrationXrequiresXsafetyXtrainingXbeforeXindependentXw
llyXthereafter.

DIF: LevelX1

5. InXsafetyXtraining,XemployeesXmustXbecomeXfamiliarXwithXallXofXtheXfollowingXexcept:
a. tasksXthatXhaveXanXinfectiousXrisk.
b. limitsXofXprotectiveXclothingXandXequipment.
c. theXappropriateXactionXtoXtakeXifXexposureXoccurs.

, 7. WhichXofXtheXfollowingXisXtrueXregardingXgoodXmanufacturingXpracticesX(GMPs)?
a. GMPsXareXlegalXrequirementsXestablishedXbyXtheXFoodXandXDrugXAdministration.
b. GMPsXareXoptionalXguidelinesXwrittenXbyXtheXAABB.
c. GMPsXareXrequiredXonlyXbyXpharmaceuticalXcompanies.
d. GMPsXareXpartXofXtheXqualityXcontrolXrequirementsXforXbloodXproducts.
ANS:X A
GoodXmanufacturingXpracticesXareXrequirementsXestablishedXbyXtheXFoodXandXDrugXAdministratio

DIF: LevelX1

8. WhichXofXtheXfollowingXisXanXexampleXofXanXunacceptableXrecord-keepingXprocedure?
a. UsingXdittosXinXcolumnsXtoXsaveXtime
b. RecordingXtheXdateXandXinitialsXnextXtoXaXcorrection
c. NotXdeletingXtheXoriginalXentryXwhenXmakingXaXcorrection
d. AlwaysXusingXpermanentXinkXonXallXrecords
ANS:X A
AllXrecordsXmustXbeXclearlyXwritten.XDittosXareXunacceptable.

DIF: LevelX1

9. AXtechnologistXinXtrainingXnoticedXthatXtheXpersonXtrainingXherXhadXnotXrecordedXtheXresultsXofXa
heXcarefullyXrecordedXtheXresultsXsheXsawXatXaXlaterXtime,XusingXtheXtechnologist’sXinitials.XIsXthi
dure?
a. Yes;XallXresultsXmustXbeXrecordedXregardlessXofXwhoXdidXtheXtest.
b. No;XsheXshouldXhaveXbroughtXtheXerrorXtoXtheXtechnologist’sXattention.
c. Yes;XbecauseXsheXusedXtheXotherXtechnologist’sXinitials.
d. Yes;XasXlongXasXsheXrecordsXtheXresultXinXpencil.
ANS:X B
ThisXisXanXexampleXofXpoorXrecordXkeeping;XresultsXmustXbeXrecordedXwhenXtheXtestXisXperforme
eXtest.

DIF: LevelX3

10. UnacceptableXqualityXcontrolXresultsXforXtheXantiglobulinXtestXperformedXinXtestXtubesXmayXbeXno
a. preventiveXmaintenanceXhasXnotXbeenXperformedXonXtheXcellXwasher.
b. theXtechnologistXperformingXtheXtestXwasXneverXtrained.
c. theXreagentsXusedXwereXimproperlyXstored.
d. AllXofXtheXabove
ANS:X D
Training,XequipmentXmaintenance,XandXreagentXqualityXcanXaffectXqualityXcontrol.

DIF: LevelX2

11. AllXofXtheXfollowingXareXtrueXregardingXcompetencyXtestingXexcept:
a. itXmustXbeXperformedXfollowingXtraining.
b. itXmustXbeXperformedXonXanXannualXbasis.
c. itXisXrequiredXonlyXifXtheXtechnologistXhasXnoXexperience.
d. retrainingXisXrequiredXifXthereXisXaXfailureXinXcompetencyXtesting.
ANS:X C
AllXemployeesXmustXhaveXcompetencyXtestingXfollowingXtrainingXandXannuallyXthereafter.XIfXthere
sting,XretrainingXisXrequired.

DIF: LevelX2

12. WhichXofXtheXfollowingXorganizationsXareXinvolvedXinXtheXregulationXofXbloodXbanks?
a. TheXJointXCommission

,14. TheXstandardXoperatingXprocedureXisXaXdocumentXthat:
a. helpsXachieveXconsistencyXofXresults.
b. mayXbeXsubstitutedXwithXpackageXinserts.
c. isXnecessaryXonlyXforXtrainingXnewXemployees.
d. mustXbeXveryXdetailedXtoXbeXaccurate.
ANS:X A
StandardXoperatingXproceduresXareXwrittenXproceduresXthatXhelpXachieveXconsistencyXandXshouldX

DIF: LevelX2

15. EmployeeXtrainingXtakesXplace:
a. afterXhiringXandXfollowingXimplementationXofXnewXprocedures.
b. followingXcompetencyXassessment.
c. onlyXforXnewXinexperiencedXemployees.
d. asXproceduresXareXvalidated.
ANS:X A
TrainingXoccursXwithXallXnewXemployeesXregardlessXofXtheirXexperienceXandXfollowingXimplement

DIF: LevelX1

16. PlansXthatXprovideXtheXframeworkXforXestablishingXqualityXassuranceXinXanXorganizationXare:
a. currentXgoodXmanufacturingXpractices.
b. standardXoperatingXprocedures.
c. changeXcontrolXplan.
d. continuousXqualityXimprovementXplan.
ANS:X D
TheXtotalXqualityXmanagementXorXcontinuousXqualityXimprovementXplanXareXpartXofXtheXqualityXa
zation.

DIF: LevelX1

17. AXfacilityXdoesXnotXvalidateXaXrefrigeratorXbeforeXuse.XWhatXisXaXpotentialXoutcome?
a. TheXfacilityXisXinXviolationXofXcurrentXgoodXmanufacturingXpracticesXandXco
uldXbeXcitedXbyXtheXFoodXandXDrugXAdministration.
b. TheXfacilityXisXinXcomplianceXifXtheXequipmentXfunctionsXproperly.
c. TheXfacilityXisXinXcomplianceXifXtheXbloodXproductsXstoredXinXitXareXnotXtransfused.
d. TheXfacilityXisXinXviolationXofXAABBXandXmayXnoXlongerXbeXmembers.
ANS:X A
ValidationXofXequipmentXisXaXcurrentXgoodXmanufacturingXpractice,XwhichXisXaXlegalXrequirementX
DrugXAdministration.

DIF: LevelX2


MULTIPLEXRESPONS
E

1. InXaXroutineXauditXofXaXfacilitiesXbloodXcollectionXarea,XtheXqualityXassuranceXdepartmentXfoundXt
sedXonXthatXparticularXdayXhadXexpired.XWhatXisXtheXappropriateXcourseXofXaction?X(SelectXallXtha
a. InitiateXaXrootXcauseXanalysisXandXquarantineXtheXbloodXcollectedXinXtheX
expiredXbags.
b. NotifyXtheXFDAXsinceXtheXexpiredXbagsXwereXdistributed.
c. ChangeXtheXexpirationXdateXonXtheXbagsXtoXavoidXlegalXissues.
d. FireXtheXdonorXroomXsupervisor,XandXdiscardXtheXbloodXcollectedXinXtheX
expiredXbags.
ANS:X A,XB
AXrootXcauseXanalysisXwillXdetermineXtheXfactorsXthatXcontributedXtoXtheXerrorXandXresultXinXaXpl

, MATCHING

MatchXtheXgovernmentXorXaccreditingXagenciesXwithXtheXdescriptionXthatXbestXfitsXtheirXpurpose.
a. EnsuresXsafeXandXhealthfulXworkingXconditions
b. EnsuresXtheXsafetyXandXefficacyXofXbiologics,Xdrugs,XandXdevices
c. ProvidesXpeer-reviewedXaccreditationXforXhospitalXlaboratories
d. ProfessionalXorganizationXthatXaccreditsXbloodXbanksXandXtransfusionXservices
e. MakesXrecommendationsXtoXtheXOccupationalXSafetyXandXHealthXAdministr
ationXregardingXtheXpreventionXofXdiseaseXtransmission
1. FDA
2. OSHA
3. CDC
4. AABB
5. CAP

1.X X ANS B DIF: LevelX1
:
2.X X ANS A DIF: LevelX1
:
3.X X ANS E DIF: LevelX1
:
4.X X ANS D DIF: LevelX1
:
5.X X ANS C DIF: LevelX1
:

MatchXtheXfollowingXdescriptionsXwithXtheXappropriateXterms.
a. TheXCAPXsurveyXisXanXexample
b. SystematicXevaluationsXtoXdetermineXwhetherXproceduresXareXbeingXfollowed
c. TestingXtoXdetermineXtheXaccuracyXandXprecisionXofXreagentsXandXequipment
d. ProcessXofXstandardizingXanXinstrumentXagainstXaXknownXvalue
e. RemovalXofXproductsXfromXtheXmarketXthatXmightXcompromiseXtheXsafety
XofXtheXrecipient
f. DegreeXtoXwhichXaXmeasurementXrepresentsXtheXtrueXvalue
g. EstablishingXthatXaXspecificXprocessXproducesXanXexpectedXresult
h. EvaluationXofXanXemployee’sXabilityXtoXperformXaXspecificXskill
i. InvestigationXandXidentificationXofXtheXfactorsXthatXcontributedXtoXanXerror
j. MaximizesXtheXdurationXofXequipmentXandXincreasesXtheXreliabilityX
ofXtheXequipment
k. SystemXtoXplanXandXimplementXchangesXtoXpreventXproblems

6. RootXcauseXanalysis
7. Recall
8. Accuracy
9. Validation
10. Calibration
11. QualityXcontrol
12. ProficiencyXtest
13. CompetencyXassessment
14. ChangeXcontrol
15. Audit
16. PreventiveXmaintenance

6.X X ANS I DIF: LevelX1
:
7.X X ANS E DIF: LevelX1
:

8.X X ANS F DIF: LevelX1