TESTBANK
= = = = = =
=
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION PRATICES 5TH EDITION
= = = = =
Paula R. Howard
= =
, Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank 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. ho
w=many=biohaza
ANS:= rdous=waste=cont
ainers=a=laborato
ry=must=have.
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=had=too=many=wrinkles=when=
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=bring=lab=coats=home=for=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=permitted=and=annually=therea
fter.
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.
d. how=to=perform=cardiopulmonary=resuscitation=on=a=donor=or=other=employee.
ANS:= D
The=Occupational=Safety=and=Health=Administration=requirements=include=all=of=those=listed=except=cardiopulmonary=resuscitation.
DIF: Level=1
6. Blood=irradiators=require=all=of=the=following=safety=procedures= except:
a. proper=training.
b. that=the=user=have=a=degree=in=radiology.
c. equipment=leak=detection.
d. personal=protective=equipment.
ANS:= B
Blood=bank=and=transfusion=service=technologists=require=training=but=not=a=degree=to=use=a=blood=irradiator.
DIF: Level=2
Copyright=©=2021,=Elsevier=Inc.=All=rights=reserved. 1
, 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. A=technologist=in=training=noticed=that=the=person=training=her=had=not=recorded=the=results=of=a=test.=To=be=helpful,=she=carefully=
recorded=the=results=she=saw=at=a=later=time,=using=the=technologist’s=initials.=Is=this=an=acceptable=procedure?
a. Yes;=all=results=must=be=recorded=regardless=of=who=did=the=test.
b. No;=she=should=have=brought=the=error=to=the=technologist’s=attention.
c. Yes;=because=she=used=the=other=technologist’s=initials.
d. Yes;=as=long=as=she=records=the=result=in=pencil.
ANS:= B
This=is=an=example=of=poor=record=keeping;=results=must=be=recorded=when=the=test=is=performed=and=by=the=person=doing=the=test.
DIF: Level=3
10. Unacceptable=quality=control=results=for=the=antiglobulin=test=performed=in=test=tubes=may=be=noticed=if:
a. preventive=maintenance=has=not=been=performed=on=the=cell=washer.
b. the=technologist=performing=the=test=was=never=trained.
c. the=reagents=used=were=improperly=stored.
d. All=of=the=above
ANS:= D
Training,=equipment=maintenance,=and=reagent=quality=can=affect=quality=control.
DIF: Level=2
11. All=of=the=following=are=true=regarding=competency=testing= except:
a. it=must=be=performed=following=training.
b. it=must=be=performed=on=an=annual=basis.
c. it=is=required=only=if=the=technologist=has=no=experience.
d. retraining=is=required=if=there=is=a=failure=in=competency=testing.
ANS:= C
All=employees=must=have=competency=testing=following=training=and=annually=thereafter.=If=there=is=a=failure=in=competency=testing,=retrai
ning=is=required.
DIF: Level=2
12. Which=of=the=following=organizations=are=involved=in=the=regulation=of=blood=banks?
a. The=Joint=Commission
b. AABB
c. College=of=American=Pathologists
d. Food=and=Drug=Administration
ANS:= D
The=Food=and=Drug=Administration=regulates=blood=banks,=whereas=the=other=organizations=are=involved=in=accreditation.
DIF: Level=1
13. All=of=the=following=are=responsibilities=of=the=quality=assurance=department=of=a=blood=bank= except:
a. performing=internal=audits.
b. performing=quality=control.
c. reviewing=standard=operating=procedures.
d. reviewing=and=approving=training=programs.
ANS:= B
Quality=control=is=performed=in=the=laboratory,=not=by=the=quality=assurance=department.
DIF: Level=2
Copyright=©=2021,=Elsevier=Inc.=All=rights=reserved. 2
, 14. The=standard=operating=procedure=is=a=document=that:
a. helps=achieve=consistency=of=results.
b. may=be=substituted=with=package=inserts.
c. is=necessary=only=for=training=new=employees.
d. must=be=very=detailed=to=be=accurate.
ANS:= A
Standard=operating=procedures=are=written=procedures=that=help=achieve=consistency=and=should=be=clear=and=concise.
DIF: Level=2
15. Employee=training=takes=place:
a. after=hiring=and=following=implementation=of=new=procedures.
b. following=competency=assessment.
c. only=for=new=inexperienced=employees.
d. as=procedures=are=validated.
ANS:= A
Training=occurs=with=all=new=employees=regardless=of=their=experience=and=following=implementation=of=new=procedures.
DIF: Level=1
16. Plans=that=provide=the=framework=for=establishing=quality=assurance=in=an=organization=are:
a. current=good=manufacturing=practices.
b. standard=operating=procedures.
c. change=control=plan.
d. continuous=quality=improvement=plan.
ANS:= D
The=total=quality=management=or=continuous=quality=improvement=plan=are=part=of=the=quality=assurance=program=in=an=organization.
DIF: Level=1
17. A=facility=does=not=validate=a=refrigerator=before=use.=What=is=a=potential=outcome?
a. The=facility=is=in=violation=of=current=good=manufacturing=practices=and=could=be=
cited=by=the=Food=and=Drug=Administration.
b. The=facility=is=in=compliance=if=the=equipment=functions=properly.
c. The=facility=is=in=compliance=if=the=blood=products=stored=in=it=are=not=transfused.
d. The=facility=is=in=violation=of=AABB=and=may=no=longer=be=members.
ANS:= A
Validation=of=equipment=is=a=current=good=manufacturing=practice,=which=is=a=legal=requirement=established=by=the=Food=and=Drug=Admin
istration.
DIF: Level=2
MULTIPLE=RESPONSE
1. In=a=routine=audit=of=a=facilities=blood=collection=area,=the=quality=assurance=department=found=that=the=blood=bags=used=on=that=
particular=day=had=expired.=What=is=the=appropriate=course=of=action?=(Select=all=that=apply.)
a. Initiate=a=root=cause=analysis=and=quarantine=the=blood=collected=in=the=expired=
bags.
b. Notify=the=FDA=since=the=expired=bags=were=distributed.
c. Change=the=expiration=date=on=the=bags=to=avoid=legal=issues.
d. Fire=the=donor=room=supervisor,=and=discard=the=blood=collected=in=the=expired=
bags.
ANS:= A,=B
A=root=cause=analysis=will=determine=the=factors=that=contributed=to=the=error=and=result=in=a=plan=to=prevent=further=errors.
DIF: Level=3
2. Several=units=were=released=to=a=hospital=by=mistake=before=all=viral=marker=testing=was=completed.=What=is=the=appropriate=course=
of=action?=(Select=all=that=apply.)
a. The=error=is=reportable,=and=the=Food=and=Drug=Administration=must=be=contacted.
b. Call=the=hospital=and=request=a=quarantine=of=the=remaining=products=in=inventory.
c. Perform=a=root=cause=analysis=and,=if=the=units=are=found=to=be=negative,=report=the=
test=result=to=the=hospital.
d. Recall=only=the=units=that=are=positive=for=viral=markers.
ANS:= A,=B
Release=of=untested=units=is=a=reportable=error=to=the=Food=and=Drug=Administration=and=the=hospital=must=be=notified=to=quarantine=a
ny=remaining=products=pending=completion=of=test=results.
DIF: Level=3
Copyright=©=2021,=Elsevier=Inc.=All=rights=reserved. 3
= = = = = =
=
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION PRATICES 5TH EDITION
= = = = =
Paula R. Howard
= =
, Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank 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. ho
w=many=biohaza
ANS:= rdous=waste=cont
ainers=a=laborato
ry=must=have.
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=had=too=many=wrinkles=when=
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=bring=lab=coats=home=for=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=permitted=and=annually=therea
fter.
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.
d. how=to=perform=cardiopulmonary=resuscitation=on=a=donor=or=other=employee.
ANS:= D
The=Occupational=Safety=and=Health=Administration=requirements=include=all=of=those=listed=except=cardiopulmonary=resuscitation.
DIF: Level=1
6. Blood=irradiators=require=all=of=the=following=safety=procedures= except:
a. proper=training.
b. that=the=user=have=a=degree=in=radiology.
c. equipment=leak=detection.
d. personal=protective=equipment.
ANS:= B
Blood=bank=and=transfusion=service=technologists=require=training=but=not=a=degree=to=use=a=blood=irradiator.
DIF: Level=2
Copyright=©=2021,=Elsevier=Inc.=All=rights=reserved. 1
, 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. A=technologist=in=training=noticed=that=the=person=training=her=had=not=recorded=the=results=of=a=test.=To=be=helpful,=she=carefully=
recorded=the=results=she=saw=at=a=later=time,=using=the=technologist’s=initials.=Is=this=an=acceptable=procedure?
a. Yes;=all=results=must=be=recorded=regardless=of=who=did=the=test.
b. No;=she=should=have=brought=the=error=to=the=technologist’s=attention.
c. Yes;=because=she=used=the=other=technologist’s=initials.
d. Yes;=as=long=as=she=records=the=result=in=pencil.
ANS:= B
This=is=an=example=of=poor=record=keeping;=results=must=be=recorded=when=the=test=is=performed=and=by=the=person=doing=the=test.
DIF: Level=3
10. Unacceptable=quality=control=results=for=the=antiglobulin=test=performed=in=test=tubes=may=be=noticed=if:
a. preventive=maintenance=has=not=been=performed=on=the=cell=washer.
b. the=technologist=performing=the=test=was=never=trained.
c. the=reagents=used=were=improperly=stored.
d. All=of=the=above
ANS:= D
Training,=equipment=maintenance,=and=reagent=quality=can=affect=quality=control.
DIF: Level=2
11. All=of=the=following=are=true=regarding=competency=testing= except:
a. it=must=be=performed=following=training.
b. it=must=be=performed=on=an=annual=basis.
c. it=is=required=only=if=the=technologist=has=no=experience.
d. retraining=is=required=if=there=is=a=failure=in=competency=testing.
ANS:= C
All=employees=must=have=competency=testing=following=training=and=annually=thereafter.=If=there=is=a=failure=in=competency=testing,=retrai
ning=is=required.
DIF: Level=2
12. Which=of=the=following=organizations=are=involved=in=the=regulation=of=blood=banks?
a. The=Joint=Commission
b. AABB
c. College=of=American=Pathologists
d. Food=and=Drug=Administration
ANS:= D
The=Food=and=Drug=Administration=regulates=blood=banks,=whereas=the=other=organizations=are=involved=in=accreditation.
DIF: Level=1
13. All=of=the=following=are=responsibilities=of=the=quality=assurance=department=of=a=blood=bank= except:
a. performing=internal=audits.
b. performing=quality=control.
c. reviewing=standard=operating=procedures.
d. reviewing=and=approving=training=programs.
ANS:= B
Quality=control=is=performed=in=the=laboratory,=not=by=the=quality=assurance=department.
DIF: Level=2
Copyright=©=2021,=Elsevier=Inc.=All=rights=reserved. 2
, 14. The=standard=operating=procedure=is=a=document=that:
a. helps=achieve=consistency=of=results.
b. may=be=substituted=with=package=inserts.
c. is=necessary=only=for=training=new=employees.
d. must=be=very=detailed=to=be=accurate.
ANS:= A
Standard=operating=procedures=are=written=procedures=that=help=achieve=consistency=and=should=be=clear=and=concise.
DIF: Level=2
15. Employee=training=takes=place:
a. after=hiring=and=following=implementation=of=new=procedures.
b. following=competency=assessment.
c. only=for=new=inexperienced=employees.
d. as=procedures=are=validated.
ANS:= A
Training=occurs=with=all=new=employees=regardless=of=their=experience=and=following=implementation=of=new=procedures.
DIF: Level=1
16. Plans=that=provide=the=framework=for=establishing=quality=assurance=in=an=organization=are:
a. current=good=manufacturing=practices.
b. standard=operating=procedures.
c. change=control=plan.
d. continuous=quality=improvement=plan.
ANS:= D
The=total=quality=management=or=continuous=quality=improvement=plan=are=part=of=the=quality=assurance=program=in=an=organization.
DIF: Level=1
17. A=facility=does=not=validate=a=refrigerator=before=use.=What=is=a=potential=outcome?
a. The=facility=is=in=violation=of=current=good=manufacturing=practices=and=could=be=
cited=by=the=Food=and=Drug=Administration.
b. The=facility=is=in=compliance=if=the=equipment=functions=properly.
c. The=facility=is=in=compliance=if=the=blood=products=stored=in=it=are=not=transfused.
d. The=facility=is=in=violation=of=AABB=and=may=no=longer=be=members.
ANS:= A
Validation=of=equipment=is=a=current=good=manufacturing=practice,=which=is=a=legal=requirement=established=by=the=Food=and=Drug=Admin
istration.
DIF: Level=2
MULTIPLE=RESPONSE
1. In=a=routine=audit=of=a=facilities=blood=collection=area,=the=quality=assurance=department=found=that=the=blood=bags=used=on=that=
particular=day=had=expired.=What=is=the=appropriate=course=of=action?=(Select=all=that=apply.)
a. Initiate=a=root=cause=analysis=and=quarantine=the=blood=collected=in=the=expired=
bags.
b. Notify=the=FDA=since=the=expired=bags=were=distributed.
c. Change=the=expiration=date=on=the=bags=to=avoid=legal=issues.
d. Fire=the=donor=room=supervisor,=and=discard=the=blood=collected=in=the=expired=
bags.
ANS:= A,=B
A=root=cause=analysis=will=determine=the=factors=that=contributed=to=the=error=and=result=in=a=plan=to=prevent=further=errors.
DIF: Level=3
2. Several=units=were=released=to=a=hospital=by=mistake=before=all=viral=marker=testing=was=completed.=What=is=the=appropriate=course=
of=action?=(Select=all=that=apply.)
a. The=error=is=reportable,=and=the=Food=and=Drug=Administration=must=be=contacted.
b. Call=the=hospital=and=request=a=quarantine=of=the=remaining=products=in=inventory.
c. Perform=a=root=cause=analysis=and,=if=the=units=are=found=to=be=negative,=report=the=
test=result=to=the=hospital.
d. Recall=only=the=units=that=are=positive=for=viral=markers.
ANS:= A,=B
Release=of=untested=units=is=a=reportable=error=to=the=Food=and=Drug=Administration=and=the=hospital=must=be=notified=to=quarantine=a
ny=remaining=products=pending=completion=of=test=results.
DIF: Level=3
Copyright=©=2021,=Elsevier=Inc.=All=rights=reserved. 3
