TESTBANK |
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 Bloo
| | | | | | | | | | | | | | |
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 |had
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 |bri
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 |per
|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.
d. how |to |perform |cardiopulmonary |resuscitation |on |a |donor |or |other |employee.
, 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 |h
recorded |the |results |she |saw |at |a |later |time, |using |the |technologist’s |initials. |Is |this |an |acceptable |procedu
|
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
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 |failu
|retraining |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
, 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 |a
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 |n
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 |p
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 |establishe
|Administration.
DIF: Level |2
MULTIPLE |RESPONSE
1. In |a |routine |audit |of |a |facilities |blood |collection |area, |the |quality |assurance |department |found |that |the |bloo
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
DIF: Level |3
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 Bloo
| | | | | | | | | | | | | | |
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 |had
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 |bri
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 |per
|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.
d. how |to |perform |cardiopulmonary |resuscitation |on |a |donor |or |other |employee.
, 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 |h
recorded |the |results |she |saw |at |a |later |time, |using |the |technologist’s |initials. |Is |this |an |acceptable |procedu
|
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
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 |failu
|retraining |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
, 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 |a
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 |n
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 |p
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 |establishe
|Administration.
DIF: Level |2
MULTIPLE |RESPONSE
1. In |a |routine |audit |of |a |facilities |blood |collection |area, |the |quality |assurance |department |found |that |the |bloo
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
DIF: Level |3
