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. A technologist in training noticed that the person training her had not recorded the results of a test. To b
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable proced
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
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 fa
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 astandard aoperating aprocedure ais aa adocument athat:
a. helps aachieve aconsistency aof aresults.
b. may abe asubstituted awith apackage ainserts.
c. is anecessary aonly afor atraining anew aemployees.
d. must abe avery adetailed ato abe aaccurate.
ANS: a A
Standard aoperating aprocedures aare awritten aprocedures athat ahelp aachieve aconsistency aand ashould ab
DIF: Level a2
15. Employee atraining atakes aplace:
a. after ahiring aand afollowing aimplementation aof anew aprocedures.
b. following acompetency aassessment.
c. only afor anew ainexperienced aemployees.
d. as aprocedures aare avalidated.
ANS: a A
Training aoccurs awith aall anew aemployees aregardless aof atheir aexperience aand afollowing aimplement
DIF: Level a1
16. Plans athat aprovide athe aframework afor aestablishing aquality aassurance ain aan aorganization aare:
a. current agood amanufacturing apractices.
b. standard aoperating aprocedures.
c. change acontrol aplan.
d. continuous aquality aimprovement aplan.
ANS: a D
The atotal aquality amanagement aor acontinuous aquality aimprovement aplan aare apart aof athe aquality aas
aorganization.
DIF: Level a1
17. A afacility adoes anot avalidate aa arefrigerator abefore ause. aWhat ais aa apotential aoutcome?
a. The afacility ais ain aviolation aof acurrent agood amanufacturing apractices aand
acould abe acited aby athe aFood aand aDrug aAdministration.
b. The afacility ais ain acompliance aif athe aequipment afunctions aproperly.
c. The afacility ais ain acompliance aif athe ablood aproducts astored ain ait aare anot atransfused.
d. The afacility ais ain aviolation aof aAABB aand amay ano alonger abe amembers.
ANS: a A
Validation aof aequipment ais aa acurrent agood amanufacturing apractice, awhich ais aa alegal arequirement a
aDrug aAdministration.
DIF: Level a2
MULTIPLE aRESPONSE
1. In aa aroutine aaudit aof aa afacilities ablood acollection aarea, athe aquality aassurance adepartment afound ath
aused aon athat aparticular aday ahad aexpired. aWhat ais athe aappropriate acourse aof aaction? a(Select aall at
a. Initiate aa aroot acause aanalysis aand aquarantine athe ablood acollected ain athe
aexpired abags.
b. Notify athe aFDA asince athe aexpired abags awere adistributed.
c. Change athe aexpiration adate aon athe abags ato aavoid alegal aissues.
d. Fire athe adonor aroom asupervisor, aand adiscard athe ablood acollected ain athe
aexpired abags.
ANS: a A, aB
A aroot acause aanalysis awill adetermine athe afactors athat acontributed ato athe aerror aand aresult ain aa apla
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. A technologist in training noticed that the person training her had not recorded the results of a test. To b
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable proced
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
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 fa
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 astandard aoperating aprocedure ais aa adocument athat:
a. helps aachieve aconsistency aof aresults.
b. may abe asubstituted awith apackage ainserts.
c. is anecessary aonly afor atraining anew aemployees.
d. must abe avery adetailed ato abe aaccurate.
ANS: a A
Standard aoperating aprocedures aare awritten aprocedures athat ahelp aachieve aconsistency aand ashould ab
DIF: Level a2
15. Employee atraining atakes aplace:
a. after ahiring aand afollowing aimplementation aof anew aprocedures.
b. following acompetency aassessment.
c. only afor anew ainexperienced aemployees.
d. as aprocedures aare avalidated.
ANS: a A
Training aoccurs awith aall anew aemployees aregardless aof atheir aexperience aand afollowing aimplement
DIF: Level a1
16. Plans athat aprovide athe aframework afor aestablishing aquality aassurance ain aan aorganization aare:
a. current agood amanufacturing apractices.
b. standard aoperating aprocedures.
c. change acontrol aplan.
d. continuous aquality aimprovement aplan.
ANS: a D
The atotal aquality amanagement aor acontinuous aquality aimprovement aplan aare apart aof athe aquality aas
aorganization.
DIF: Level a1
17. A afacility adoes anot avalidate aa arefrigerator abefore ause. aWhat ais aa apotential aoutcome?
a. The afacility ais ain aviolation aof acurrent agood amanufacturing apractices aand
acould abe acited aby athe aFood aand aDrug aAdministration.
b. The afacility ais ain acompliance aif athe aequipment afunctions aproperly.
c. The afacility ais ain acompliance aif athe ablood aproducts astored ain ait aare anot atransfused.
d. The afacility ais ain aviolation aof aAABB aand amay ano alonger abe amembers.
ANS: a A
Validation aof aequipment ais aa acurrent agood amanufacturing apractice, awhich ais aa alegal arequirement a
aDrug aAdministration.
DIF: Level a2
MULTIPLE aRESPONSE
1. In aa aroutine aaudit aof aa afacilities ablood acollection aarea, athe aquality aassurance adepartment afound ath
aused aon athat aparticular aday ahad aexpired. aWhat ais athe aappropriate acourse aof aaction? a(Select aall at
a. Initiate aa aroot acause aanalysis aand aquarantine athe ablood acollected ain athe
aexpired abags.
b. Notify athe aFDA asince athe aexpired abags awere adistributed.
c. Change athe aexpiration adate aon athe abags ato aavoid alegal aissues.
d. Fire athe adonor aroom asupervisor, aand adiscard athe ablood acollected ain athe
aexpired abags.
ANS: a A, aB
A aroot acause aanalysis awill adetermine athe afactors athat acontributed ato athe aerror aand aresult ain aa apla
