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 fstandard foperating fprocedure fis fa fdocument fthat:
a. helps fachieve fconsistency fof fresults.
b. may fbe fsubstituted fwith fpackage finserts.
c. is fnecessary fonly ffor ftraining fnew femployees.
d. must fbe fvery fdetailed fto fbe faccurate.
ANS: f A
Standard foperating fprocedures fare fwritten fprocedures fthat fhelp fachieve fconsistency fand fshould fbe
DIF: Level f2
15. Employee ftraining ftakes fplace:
a. after fhiring fand ffollowing fimplementation fof fnew fprocedures.
b. following fcompetency fassessment.
c. only ffor fnew finexperienced femployees.
d. as fprocedures fare fvalidated.
ANS: f A
Training foccurs fwith fall fnew femployees fregardless fof ftheir fexperience fand ffollowing fimplementati
DIF: Level f1
16. Plans fthat fprovide fthe fframework ffor festablishing fquality fassurance fin fan forganization fare:
a. current fgood fmanufacturing fpractices.
b. standard foperating fprocedures.
c. change fcontrol fplan.
d. continuous fquality fimprovement fplan.
ANS: f D
The ftotal fquality fmanagement for fcontinuous fquality fimprovement fplan fare fpart fof fthe fquality fassu
forganization.
DIF: Level f1
17. A ffacility fdoes fnot fvalidate fa frefrigerator fbefore fuse. fWhat fis fa fpotential foutcome?
a. The ffacility fis fin fviolation fof fcurrent fgood fmanufacturing fpractices fand fcould
fbe fcited fby fthe fFood fand fDrug fAdministration.
b. The ffacility fis fin fcompliance fif fthe fequipment ffunctions fproperly.
c. The ffacility fis fin fcompliance fif fthe fblood fproducts fstored fin fit fare fnot ftransfused.
d. The ffacility fis fin fviolation fof fAABB fand fmay fno flonger fbe fmembers.
ANS: f A
Validation fof fequipment fis fa fcurrent fgood fmanufacturing fpractice, fwhich fis fa flegal frequirement fest
fAdministration.
DIF: Level f2
MULTIPLE fRESPONSE
1. In fa froutine faudit fof fa ffacilities fblood fcollection farea, fthe fquality fassurance fdepartment ffound fthat
fon fthat fparticular fday fhad fexpired. fWhat fis fthe fappropriate fcourse fof faction? f(Select fall fthat fapply
a. Initiate fa froot fcause fanalysis fand fquarantine fthe fblood fcollected fin fthe
fexpired fbags.
b. Notify fthe fFDA fsince fthe fexpired fbags fwere fdistributed.
c. Change fthe fexpiration fdate fon fthe fbags fto favoid flegal fissues.
d. Fire fthe fdonor froom fsupervisor, fand fdiscard fthe fblood fcollected fin fthe
fexpired fbags.
ANS: f A, fB
A froot fcause fanalysis fwill fdetermine fthe ffactors fthat fcontributed fto fthe ferror fand fresult fin fa fplan ft
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 fstandard foperating fprocedure fis fa fdocument fthat:
a. helps fachieve fconsistency fof fresults.
b. may fbe fsubstituted fwith fpackage finserts.
c. is fnecessary fonly ffor ftraining fnew femployees.
d. must fbe fvery fdetailed fto fbe faccurate.
ANS: f A
Standard foperating fprocedures fare fwritten fprocedures fthat fhelp fachieve fconsistency fand fshould fbe
DIF: Level f2
15. Employee ftraining ftakes fplace:
a. after fhiring fand ffollowing fimplementation fof fnew fprocedures.
b. following fcompetency fassessment.
c. only ffor fnew finexperienced femployees.
d. as fprocedures fare fvalidated.
ANS: f A
Training foccurs fwith fall fnew femployees fregardless fof ftheir fexperience fand ffollowing fimplementati
DIF: Level f1
16. Plans fthat fprovide fthe fframework ffor festablishing fquality fassurance fin fan forganization fare:
a. current fgood fmanufacturing fpractices.
b. standard foperating fprocedures.
c. change fcontrol fplan.
d. continuous fquality fimprovement fplan.
ANS: f D
The ftotal fquality fmanagement for fcontinuous fquality fimprovement fplan fare fpart fof fthe fquality fassu
forganization.
DIF: Level f1
17. A ffacility fdoes fnot fvalidate fa frefrigerator fbefore fuse. fWhat fis fa fpotential foutcome?
a. The ffacility fis fin fviolation fof fcurrent fgood fmanufacturing fpractices fand fcould
fbe fcited fby fthe fFood fand fDrug fAdministration.
b. The ffacility fis fin fcompliance fif fthe fequipment ffunctions fproperly.
c. The ffacility fis fin fcompliance fif fthe fblood fproducts fstored fin fit fare fnot ftransfused.
d. The ffacility fis fin fviolation fof fAABB fand fmay fno flonger fbe fmembers.
ANS: f A
Validation fof fequipment fis fa fcurrent fgood fmanufacturing fpractice, fwhich fis fa flegal frequirement fest
fAdministration.
DIF: Level f2
MULTIPLE fRESPONSE
1. In fa froutine faudit fof fa ffacilities fblood fcollection farea, fthe fquality fassurance fdepartment ffound fthat
fon fthat fparticular fday fhad fexpired. fWhat fis fthe fappropriate fcourse fof faction? f(Select fall fthat fapply
a. Initiate fa froot fcause fanalysis fand fquarantine fthe fblood fcollected fin fthe
fexpired fbags.
b. Notify fthe fFDA fsince fthe fexpired fbags fwere fdistributed.
c. Change fthe fexpiration fdate fon fthe fbags fto favoid flegal fissues.
d. Fire fthe fdonor froom fsupervisor, fand fdiscard fthe fblood fcollected fin fthe
fexpired fbags.
ANS: f A, fB
A froot fcause fanalysis fwill fdetermine fthe ffactors fthat fcontributed fto fthe ferror fand fresult fin fa fplan ft
