TEST BANK
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION
PRACTICES 5TH EDITION
Paula R. Howard
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the B
Howard: Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
MULTIPLE CHOICE
1. Biosafety levels determine:
a. on what floor certain infectious disease testing can be performed.
b. the degree of risk for certain areas of a health care facility to exposure to
infectious diseases.
c. the amount of ventilation required in a transfusion service.
d. how many biohazardous waste containers a laboratory must have.
ANS: B
OSHA defines biosafety levels based on potential exposure to infectious material.
DIF: Level 1
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it h
it was returned by the laboratory’s laundry service. Is this practice acceptable?
a. Yes, if she uses 10% bleach
b. Yes, if she clears it with her supervisor
c. Yes, as long as she removes the coat and does not wear it home
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
removed
ANS: D
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to
cleaning.
DIF: Level 2
3. Personal protective equipment includes:
a. safety glasses.
b. splash barriers.
c. masks.
d. All of the above
ANS: D
Safety glasses, splash barriers, and masks are types of personal protective devices.
DIF: Level 1
4. At what point in the employment process should safety training take place?
a. During orientation and training
b. Following lab training when employees are more familiar with their
responsibilities
c. Following the employees’ first evaluation
d. Before independent work is permitted and annually thereafter
ANS: D
The Occupation Safety and Health Administration requires safety training before independent work is p
thereafter.
DIF: Level 1
5. In safety training, employees must become familiar with all of the following except:
a. tasks that have an infectious risk.
b. limits of protective clothing and equipment.
c. the appropriate action to take if exposure occurs.
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
a. GMPs are legal requirements established by the Food and Drug Administration.
b. GMPs are optional guidelines written by the AABB.
c. GMPs are required only by pharmaceutical companies.
d. GMPs are part of the quality control requirements for blood products.
ANS: A
Good manufacturing practices are requirements established by the Food and Drug Administration.
DIF: Level 1
8. Which of the following is an example of an unacceptable record-keeping procedure?
a. Using dittos in columns to save time
b. Recording the date and initials next to a correction
c. Not deleting the original entry when making a correction
d. Always using permanent ink on all records
ANS: A
All records must be clearly written. Dittos are unacceptable.
DIF: Level 1
9. Axtechnologistxinxtrainingxnoticedxthatxthexpersonxtrainingxherxhadxnotxrecordedxthexresultsxofxaxtest.x
fullyxrecordedxthexresultsxshexsawxatxaxlaterxtime,xusingxthextechnologist’sxinitials.xIsxthisxanxacceptab
a. Yes;xallxresultsxmustxbexrecordedxregardlessxofxwhoxdidxthextest.
b. No;xshexshouldxhavexbroughtxthexerrorxtoxthextechnologist’sxattention.
c. Yes;xbecausexshexusedxthexotherxtechnologist’sxinitials.
d. Yes;xasxlongxasxshexrecordsxthexresultxinxpencil.
ANS:x B
Thisxisxanxexamplexofxpoorxrecordxkeeping;xresultsxmustxbexrecordedxwhenxthextestxisxperformedxand
DIF: Levelx3
10. Unacceptablexqualityxcontrolxresultsxforxthexantiglobulinxtestxperformedxinxtestxtubesxmayxbexnoticed
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.xIfxtherexisxa
etrainingxisxrequired.
DIF: Levelx2
12. Whichxofxthexfollowingxorganizationsxarexinvolvedxinxthexregulationxofxbloodxbanks?
a. ThexJointxCommission
b. AABB
c. CollegexofxAmericanxPathologists
, 14. Thexstandardxoperatingxprocedurexisxaxdocumentxthat:
a. helpsxachievexconsistencyxofxresults.
b. mayxbexsubstitutedxwithxpackagexinserts.
c. isxnecessaryxonlyxforxtrainingxnewxemployees.
d. mustxbexveryxdetailedxtoxbexaccurate.
ANS:x A
Standardxoperatingxproceduresxarexwrittenxproceduresxthatxhelpxachievexconsistencyxandxshouldxbexcl
DIF: Levelx2
15. Employeextrainingxtakesxplace:
a. afterxhiringxandxfollowingximplementationxofxnewxprocedures.
b. followingxcompetencyxassessment.
c. onlyxforxnewxinexperiencedxemployees.
d. asxproceduresxarexvalidated.
ANS:x A
Trainingxoccursxwithxallxnewxemployeesxregardlessxofxtheirxexperiencexandxfollowingximplementation
DIF: Levelx1
16. Plansxthatxprovidexthexframeworkxforxestablishingxqualityxassurancexinxanxorganizationxare:
a. currentxgoodxmanufacturingxpractices.
b. standardxoperatingxprocedures.
c. changexcontrolxplan.
d. continuousxqualityximprovementxplan.
ANS:x D
Thextotalxqualityxmanagementxorxcontinuousxqualityximprovementxplanxarexpartxofxthexqualityxassura
DIF: Levelx1
17. Axfacilityxdoesxnotxvalidatexaxrefrigeratorxbeforexuse.xWhatxisxaxpotentialxoutcome?
a. Thexfacilityxisxinxviolationxofxcurrentxgoodxmanufacturingxpracticesxandxcouldx
bexcitedxbyxthexFoodxandxDrugxAdministration.
b. Thexfacilityxisxinxcompliancexifxthexequipmentxfunctionsxproperly.
c. Thexfacilityxisxinxcompliancexifxthexbloodxproductsxstoredxinxitxarexnotxtransfused.
d. ThexfacilityxisxinxviolationxofxAABBxandxmayxnoxlongerxbexmembers.
ANS:x A
Validationxofxequipmentxisxaxcurrentxgoodxmanufacturingxpractice,xwhichxisxaxlegalxrequirementxestab
dministration.
DIF: Levelx2
MULTIPLExRESPONSE
1. Inxaxroutinexauditxofxaxfacilitiesxbloodxcollectionxarea,xthexqualityxassurancexdepartmentxfoundxthatxth
xthatxparticularxdayxhadxexpired.xWhatxisxthexappropriatexcoursexofxaction?x(Selectxallxthatxapply.)
a. Initiatexaxrootxcausexanalysisxandxquarantinexthexbloodxcollectedxinxthexexpir
edxbags.
b. NotifyxthexFDAxsincexthexexpiredxbagsxwerexdistributed.
c. Changexthexexpirationxdatexonxthexbagsxtoxavoidxlegalxissues.
d. Firexthexdonorxroomxsupervisor,xandxdiscardxthexbloodxcollectedxinxthexexpir
edxbags.
ANS:x A,xB
Axrootxcausexanalysisxwillxdeterminexthexfactorsxthatxcontributedxtoxthexerrorxandxresultxinxaxplanxtox
DIF: Levelx3
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION
PRACTICES 5TH EDITION
Paula R. Howard
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the B
Howard: Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
MULTIPLE CHOICE
1. Biosafety levels determine:
a. on what floor certain infectious disease testing can be performed.
b. the degree of risk for certain areas of a health care facility to exposure to
infectious diseases.
c. the amount of ventilation required in a transfusion service.
d. how many biohazardous waste containers a laboratory must have.
ANS: B
OSHA defines biosafety levels based on potential exposure to infectious material.
DIF: Level 1
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it h
it was returned by the laboratory’s laundry service. Is this practice acceptable?
a. Yes, if she uses 10% bleach
b. Yes, if she clears it with her supervisor
c. Yes, as long as she removes the coat and does not wear it home
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
removed
ANS: D
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to
cleaning.
DIF: Level 2
3. Personal protective equipment includes:
a. safety glasses.
b. splash barriers.
c. masks.
d. All of the above
ANS: D
Safety glasses, splash barriers, and masks are types of personal protective devices.
DIF: Level 1
4. At what point in the employment process should safety training take place?
a. During orientation and training
b. Following lab training when employees are more familiar with their
responsibilities
c. Following the employees’ first evaluation
d. Before independent work is permitted and annually thereafter
ANS: D
The Occupation Safety and Health Administration requires safety training before independent work is p
thereafter.
DIF: Level 1
5. In safety training, employees must become familiar with all of the following except:
a. tasks that have an infectious risk.
b. limits of protective clothing and equipment.
c. the appropriate action to take if exposure occurs.
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
a. GMPs are legal requirements established by the Food and Drug Administration.
b. GMPs are optional guidelines written by the AABB.
c. GMPs are required only by pharmaceutical companies.
d. GMPs are part of the quality control requirements for blood products.
ANS: A
Good manufacturing practices are requirements established by the Food and Drug Administration.
DIF: Level 1
8. Which of the following is an example of an unacceptable record-keeping procedure?
a. Using dittos in columns to save time
b. Recording the date and initials next to a correction
c. Not deleting the original entry when making a correction
d. Always using permanent ink on all records
ANS: A
All records must be clearly written. Dittos are unacceptable.
DIF: Level 1
9. Axtechnologistxinxtrainingxnoticedxthatxthexpersonxtrainingxherxhadxnotxrecordedxthexresultsxofxaxtest.x
fullyxrecordedxthexresultsxshexsawxatxaxlaterxtime,xusingxthextechnologist’sxinitials.xIsxthisxanxacceptab
a. Yes;xallxresultsxmustxbexrecordedxregardlessxofxwhoxdidxthextest.
b. No;xshexshouldxhavexbroughtxthexerrorxtoxthextechnologist’sxattention.
c. Yes;xbecausexshexusedxthexotherxtechnologist’sxinitials.
d. Yes;xasxlongxasxshexrecordsxthexresultxinxpencil.
ANS:x B
Thisxisxanxexamplexofxpoorxrecordxkeeping;xresultsxmustxbexrecordedxwhenxthextestxisxperformedxand
DIF: Levelx3
10. Unacceptablexqualityxcontrolxresultsxforxthexantiglobulinxtestxperformedxinxtestxtubesxmayxbexnoticed
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.xIfxtherexisxa
etrainingxisxrequired.
DIF: Levelx2
12. Whichxofxthexfollowingxorganizationsxarexinvolvedxinxthexregulationxofxbloodxbanks?
a. ThexJointxCommission
b. AABB
c. CollegexofxAmericanxPathologists
, 14. Thexstandardxoperatingxprocedurexisxaxdocumentxthat:
a. helpsxachievexconsistencyxofxresults.
b. mayxbexsubstitutedxwithxpackagexinserts.
c. isxnecessaryxonlyxforxtrainingxnewxemployees.
d. mustxbexveryxdetailedxtoxbexaccurate.
ANS:x A
Standardxoperatingxproceduresxarexwrittenxproceduresxthatxhelpxachievexconsistencyxandxshouldxbexcl
DIF: Levelx2
15. Employeextrainingxtakesxplace:
a. afterxhiringxandxfollowingximplementationxofxnewxprocedures.
b. followingxcompetencyxassessment.
c. onlyxforxnewxinexperiencedxemployees.
d. asxproceduresxarexvalidated.
ANS:x A
Trainingxoccursxwithxallxnewxemployeesxregardlessxofxtheirxexperiencexandxfollowingximplementation
DIF: Levelx1
16. Plansxthatxprovidexthexframeworkxforxestablishingxqualityxassurancexinxanxorganizationxare:
a. currentxgoodxmanufacturingxpractices.
b. standardxoperatingxprocedures.
c. changexcontrolxplan.
d. continuousxqualityximprovementxplan.
ANS:x D
Thextotalxqualityxmanagementxorxcontinuousxqualityximprovementxplanxarexpartxofxthexqualityxassura
DIF: Levelx1
17. Axfacilityxdoesxnotxvalidatexaxrefrigeratorxbeforexuse.xWhatxisxaxpotentialxoutcome?
a. Thexfacilityxisxinxviolationxofxcurrentxgoodxmanufacturingxpracticesxandxcouldx
bexcitedxbyxthexFoodxandxDrugxAdministration.
b. Thexfacilityxisxinxcompliancexifxthexequipmentxfunctionsxproperly.
c. Thexfacilityxisxinxcompliancexifxthexbloodxproductsxstoredxinxitxarexnotxtransfused.
d. ThexfacilityxisxinxviolationxofxAABBxandxmayxnoxlongerxbexmembers.
ANS:x A
Validationxofxequipmentxisxaxcurrentxgoodxmanufacturingxpractice,xwhichxisxaxlegalxrequirementxestab
dministration.
DIF: Levelx2
MULTIPLExRESPONSE
1. Inxaxroutinexauditxofxaxfacilitiesxbloodxcollectionxarea,xthexqualityxassurancexdepartmentxfoundxthatxth
xthatxparticularxdayxhadxexpired.xWhatxisxthexappropriatexcoursexofxaction?x(Selectxallxthatxapply.)
a. Initiatexaxrootxcausexanalysisxandxquarantinexthexbloodxcollectedxinxthexexpir
edxbags.
b. NotifyxthexFDAxsincexthexexpiredxbagsxwerexdistributed.
c. Changexthexexpirationxdatexonxthexbagsxtoxavoidxlegalxissues.
d. Firexthexdonorxroomxsupervisor,xandxdiscardxthexbloodxcollectedxinxthexexpir
edxbags.
ANS:x A,xB
Axrootxcausexanalysisxwillxdeterminexthexfactorsxthatxcontributedxtoxthexerrorxandxresultxinxaxplanxtox
DIF: Levelx3
