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 Blood Bank Howard: B
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
asic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
sw sw sw sw sw sw sw sw sw sw sw
MULTIPLE CHOICE sw
1. Biosafety levels determine: sw sw
a. on what floor certain infectious disease testing can be performed.
sw sw sw sw sw sw sw sw sw
b. the degree of risk for certain areas of a health care facility to exposure to inf
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
ectious diseases. sw
c. the amount of ventilation required in a transfusion service.
sw sw sw sw sw sw sw sw
d. how many biohazardous waste containers a laboratory must have.
sw sw sw sw sw sw sw sw
ANS: B s w
OSHA defines biosafety levels based on potential exposure to infectious material.
sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had too many wrinkles when it w
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
as returned by the laboratory’s laundry service. Is this practice acceptable?
sw sw sw sw sw sw sw sw sw sw
a. Yes, if she uses 10% bleach sw sw sw sw sw
b. Yes, if she clears it with her supervisor sw sw sw sw sw sw sw
c. Yes, as long as she removes the coat and does not wear it home
sw sw sw sw sw sw sw sw sw sw sw sw sw
d. No, because the laboratory is a biosafety level 2, and lab coats may not be re
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
moved
ANS: D s w
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to bring lab coats home for cleaning.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
3. Personal protective equipment includes: sw sw sw
a. safety glasses. sw
b. splash barriers. sw
c. masks.
d. All of the above sw sw sw
ANS: D s w
Safety glasses, splash barriers, and masks are types of personal protective devices.
sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
4. At what point in the employment process should safety training take place?
sw sw sw sw sw sw sw sw sw sw sw
a. During orientation and training sw sw sw
b. Following lab training when employees are more familiar with their re sw sw sw sw sw sw sw sw sw sw
sponsibilities
c. Following the employees’ first evaluation sw sw sw sw
d. Before independent work is permitted and annually thereafter
sw sw sw sw sw sw sw
ANS: D s w
The Occupation Safety and Health Administration requires safety training before independent work is permitted and annually thereafter.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
5. In safety training, employees must become familiar with all of the following except:
sw sw sw sw sw sw sw sw sw sw sw sw
a. tasks that have an infectious risk. sw sw sw sw sw
b. limits of protective clothing and equipment. sw sw sw sw sw
c. the appropriate action to take if exposure occurs.
sw sw sw sw sw sw sw
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
sw sw sw sw sw sw sw sw sw sw
ANS: D s w
The Occupational Safety and Health Administration requirements include all of those listed except cardiopulmonary resuscitation.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
6. Blood irradiators require all of the following safety procedures except:
sw sw sw sw sw sw sw sw sw
a. proper training. sw
b. that the user have a degree in radiology. sw sw sw sw sw sw sw
c. equipment leak detection. sw sw
d. personal protective equipment. sw sw
ANS: B s w
Blood bank and transfusion service technologists require training but not a degree to use a blood irradiator.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
Copyright © 2021, Elsevier Inc. All rights reserved.
sw sw sw sw sw sw sw 1
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
sw sw sw sw sw sw sw sw sw sw
a. GMPs are legal requirements established by the Food and Drug Administration.
sw sw sw sw sw sw sw sw sw sw
b. GMPs are optional guidelines written by the AABB. sw sw sw sw sw sw sw
c. GMPs are required only by pharmaceutical companies. sw sw sw sw sw sw
d. GMPs are part of the quality control requirements for blood products. sw sw sw sw sw sw sw sw sw sw
ANS: A s w
Good manufacturing practices are requirements established by the Food and Drug Administration.
sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
8. Which of the following is an example of an unacceptable record-keeping procedure?
sw sw sw sw sw sw sw sw sw sw sw
a. Using dittos in columns to save time sw sw sw sw sw sw
b. Recording the date and initials next to a correction sw sw sw sw sw sw sw sw
c. Not deleting the original entry when making a correction
sw sw sw sw sw sw sw sw
d. Always using permanent ink on all records sw sw sw sw sw sw
ANS: A s w
All records must be clearly written. Dittos are unacceptable.
sw sw sw sw sw sw sw sw
DIF: Level 1 sw
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be helpful, she carefully rec
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
orded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedure?
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
a. Yes; all results must be recorded regardless of who did the test.
sw sw sw sw sw sw sw sw sw sw sw
b. No; she should have brought the error to the technologist’s attention.
sw sw sw sw sw sw sw sw sw sw
c. Yes; because she used the other technologist’s initials.
sw sw sw sw sw sw sw
d. Yes; as long as she records the result in pencil. sw sw sw sw sw sw sw sw sw
ANS: B s w
This is an example of poor record keeping; results must be recorded when the test is performed and by the person doing the test.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 3 sw
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
a. preventive maintenance has not been performed on the cell washer. sw sw sw sw sw sw sw sw sw
b. the technologist performing the test was never trained.
sw sw sw sw sw sw sw
c. the reagents used were improperly stored. sw sw sw sw sw
d. All of the above sw sw sw
ANS: D s w
Training, equipment maintenance, and reagent quality can affect quality control.
sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
11. All of the following are true regarding competency testing except:
sw sw sw sw sw sw sw sw sw
a. it must be performed following training.
sw sw sw sw sw
b. it must be performed on an annual basis.
sw sw sw sw sw sw sw
c. it is required only if the technologist has no experience.
sw sw sw sw sw sw sw sw sw
d. retraining is required if there is a failure in competency testing. sw sw sw sw sw sw sw sw sw sw
ANS: C s w
All employees must have competency testing following training and annually thereafter. If there is a failure in competency testing, retrainin
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
g is required.
sw sw
DIF: Level 2 sw
12. Which of the following organizations are involved in the regulation of blood banks?
sw sw sw sw sw sw sw sw sw sw sw sw
a. The Joint Commission sw sw
b. AABB
c. College of American Pathologists sw sw sw
d. Food and Drug Administration sw sw sw
ANS: D s w
The Food and Drug Administration regulates blood banks, whereas the other organizations are involved in accreditation.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
13. All of the following are responsibilities of the quality assurance department of a blood bank except:
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
a. performing internal audits. sw sw
b. performing quality control. sw sw
c. reviewing standard operating procedures. sw sw sw
d. reviewing and approving training programs. sw sw sw sw
ANS: B s w
Quality control is performed in the laboratory, not by the quality assurance department.
sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
Copyright © 2021, Elsevier Inc. All rights reserved.
sw sw sw sw sw sw sw 2
, 14. The zstandard zoperating zprocedure zis za zdocument zthat:
sw sw sw sw sw sw sw
a. helps zachieve zconsistency zof zresults. sw sw sw sw
b. may zbe zsubstituted zwith zpackage zinserts. sw sw sw sw sw
c. is znecessary zonly zfor ztraining znew zemployees.
sw sw sw sw sw sw
d. must zbe zvery zdetailed zto zbe zaccurate. sw sw w
s sw sw sw
ANS: s w z s w A
Standard zoperating zprocedures zare zwritten zprocedures zthat zhelp zachieve zconsistency zand zshould zbe zclear zand zconcise.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level z2 sw
15. Employee ztraining ztakes zplace: sw sw sw
a. after zhiring zand zfollowing zimplementation zof znew zprocedures.
sw sw sw sw sw sw sw
b. following zcompetency zassessment. w
s w
s
c. only zfor znew zinexperienced zemployees. sw sw sw sw
d. as zprocedures zare zvalidated. sw sw sw
ANS: s w z s w A
Training zoccurs zwith zall znew zemployees zregardless zof ztheir zexperience zand zfollowing zimplementation zof znew zprocedures.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level z1 sw
16. Plans zthat zprovide zthe zframework zfor zestablishing zquality zassurance zin zan zorganization zare:
sw sw sw sw sw sw sw sw sw sw sw sw
a. current zgood zmanufacturing zpractices. sw sw sw
b. standard zoperating zprocedures. sw sw
c. change zcontrol zplan. sw sw
d. continuous zquality zimprovement zplan. sw sw sw
ANS: s w z s w D
The ztotal zquality zmanagement zor zcontinuous zquality zimprovement zplan zare zpart zof zthe zquality zassurance zprogram zin zan zorganization
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
.
DIF: Level z1 sw
17. A zfacility zdoes znot zvalidate za zrefrigerator zbefore zuse. zWhat zis za zpotential zoutcome?
sw sw sw sw sw sw sw sw sw sw sw sw sw
a. Thezfacilityzis zin zviolation zof zcurrent zgood zmanufacturing zpractices zand zco
w
s w
s w
s w
s w
s w
s w
s w
s w
s sw sw
uld zbe zcited zby zthe zFood zand zDrug zAdministration.
sw sw sw sw sw sw sw sw
b. The zfacility zis zin zcompliance zif zthe zequipment zfunctions zproperly.
sw sw sw sw sw sw sw sw sw
c. The zfacility zis zin zcompliance zif zthe zblood zproducts zstored zin zit zare znot ztransfused.
sw w
s sw sw sw sw sw sw sw sw sw sw sw sw
d. The zfacility zis zin zviolation zof zAABB zand zmay zno zlonger zbe zmembers.
w
s w
s sw sw sw sw sw sw w
s sw sw sw
ANS: s w z s w A
Validation zof zequipment zis za zcurrent zgood zmanufacturing zpractice, zwhich zis za zlegal zrequirement zestablished zby zthe zFood zand zDrug zA
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw w
s sw sw sw w
s
dministration.
DIF: Level z2 sw
MULTIPLEzRESPONSE
1. In za zroutine zaudit zof za zfacilities zblood zcollection zarea, zthe zquality zassurance zdepartment zfound zthat zthe zblood zbags zuse
sw sw sw sw sw sw sw sw sw sw sw w
s sw sw sw sw sw sw sw
d zon zthat zparticular zday zhad zexpired. zWhat zis zthe zappropriate zcourse zof zaction? z(Select zall zthat zapply.)
sw sw sw sw w
s sw sw sw sw sw sw sw sw sw sw sw sw
a. Initiatezazrootzcausezanalysis zand zquarantine zthe zbloodzcollected zin zthe zex w
s w
s w
s w
s w
s sw sw sw w
s w
s sw sw
pired zbags. w
s
b. Notify zthe zFDA zsince zthe zexpired zbags zwere zdistributed. w
s sw sw sw sw sw sw sw
c. Change zthe zexpiration zdate zon zthe zbags zto zavoid zlegal zissues. sw sw sw sw sw sw sw sw sw sw
d. Firezthezdonorzroomzsupervisor, zand zdiscard zthezblood zcollected zin zthe zex
w
s w
s w
s w
s sw w
s w
s w
s w
s w
s w
s sw
pired zbags. w
s
ANS: s w z s w A, zB w
s
A zroot zcause zanalysis zwill zdetermine zthe zfactors zthat zcontributed zto zthe zerror zand zresult zin za zplan zto zprevent zfurther zerrors.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level z3 sw
2. Several zunits zwere zreleased zto za zhospital zbyzmistake zbefore zall zviral zmarker ztesting zwas zcompleted. zWhat zis zthe zapp
sw sw sw sw sw sw sw w
s sw sw sw sw sw sw sw sw sw sw sw
ropriate zcourse zof zaction? z(Select zall zthat zapply.)
sw sw sw sw sw sw sw
a. The zerror zis zreportable, zand zthe zFood zand zDrug zAdministration zmust zbe zcontacted.
sw sw sw sw sw sw sw sw sw sw sw sw
b. Call zthe zhospital zand zrequest za zquarantine zof zthe zremaining zproducts zin zinventory.
sw sw sw sw sw sw sw sw sw sw sw sw
c. Perform zazroot zcausezanalysis zand, zifzthezunits zare zfound zto zbeznegative, zrep w
s w
s sw w
s w
s sw w
s w
s w
s w
s w
s w
s w
s sw
ort zthe ztest zresult zto zthe zhospital.
sw sw sw sw sw sw
d. Recall zonly zthe zunits zthat zare zpositive zfor zviral zmarkers. sw sw sw sw sw sw sw sw sw
ANS: s w z s w A, zB w
s
Release zof zuntested zunits zis za zreportable zerror zto zthe zFood zand zDrug zAdministration zand zthe zhospital zmust zbe znotified zto zquarantine z
sw w
s sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw w
s sw sw sw
any zremaining zproducts zpending zcompletion zof ztest zresults.
sw sw sw sw sw sw sw
DIF: Level z3 sw
Copyright © 2021, Elsevier Inc. All rights reserved.
sw sw sw sw sw sw sw 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 Blood Bank Howard: B
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
asic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
sw sw sw sw sw sw sw sw sw sw sw
MULTIPLE CHOICE sw
1. Biosafety levels determine: sw sw
a. on what floor certain infectious disease testing can be performed.
sw sw sw sw sw sw sw sw sw
b. the degree of risk for certain areas of a health care facility to exposure to inf
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
ectious diseases. sw
c. the amount of ventilation required in a transfusion service.
sw sw sw sw sw sw sw sw
d. how many biohazardous waste containers a laboratory must have.
sw sw sw sw sw sw sw sw
ANS: B s w
OSHA defines biosafety levels based on potential exposure to infectious material.
sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had too many wrinkles when it w
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
as returned by the laboratory’s laundry service. Is this practice acceptable?
sw sw sw sw sw sw sw sw sw sw
a. Yes, if she uses 10% bleach sw sw sw sw sw
b. Yes, if she clears it with her supervisor sw sw sw sw sw sw sw
c. Yes, as long as she removes the coat and does not wear it home
sw sw sw sw sw sw sw sw sw sw sw sw sw
d. No, because the laboratory is a biosafety level 2, and lab coats may not be re
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
moved
ANS: D s w
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to bring lab coats home for cleaning.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
3. Personal protective equipment includes: sw sw sw
a. safety glasses. sw
b. splash barriers. sw
c. masks.
d. All of the above sw sw sw
ANS: D s w
Safety glasses, splash barriers, and masks are types of personal protective devices.
sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
4. At what point in the employment process should safety training take place?
sw sw sw sw sw sw sw sw sw sw sw
a. During orientation and training sw sw sw
b. Following lab training when employees are more familiar with their re sw sw sw sw sw sw sw sw sw sw
sponsibilities
c. Following the employees’ first evaluation sw sw sw sw
d. Before independent work is permitted and annually thereafter
sw sw sw sw sw sw sw
ANS: D s w
The Occupation Safety and Health Administration requires safety training before independent work is permitted and annually thereafter.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
5. In safety training, employees must become familiar with all of the following except:
sw sw sw sw sw sw sw sw sw sw sw sw
a. tasks that have an infectious risk. sw sw sw sw sw
b. limits of protective clothing and equipment. sw sw sw sw sw
c. the appropriate action to take if exposure occurs.
sw sw sw sw sw sw sw
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
sw sw sw sw sw sw sw sw sw sw
ANS: D s w
The Occupational Safety and Health Administration requirements include all of those listed except cardiopulmonary resuscitation.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
6. Blood irradiators require all of the following safety procedures except:
sw sw sw sw sw sw sw sw sw
a. proper training. sw
b. that the user have a degree in radiology. sw sw sw sw sw sw sw
c. equipment leak detection. sw sw
d. personal protective equipment. sw sw
ANS: B s w
Blood bank and transfusion service technologists require training but not a degree to use a blood irradiator.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
Copyright © 2021, Elsevier Inc. All rights reserved.
sw sw sw sw sw sw sw 1
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
sw sw sw sw sw sw sw sw sw sw
a. GMPs are legal requirements established by the Food and Drug Administration.
sw sw sw sw sw sw sw sw sw sw
b. GMPs are optional guidelines written by the AABB. sw sw sw sw sw sw sw
c. GMPs are required only by pharmaceutical companies. sw sw sw sw sw sw
d. GMPs are part of the quality control requirements for blood products. sw sw sw sw sw sw sw sw sw sw
ANS: A s w
Good manufacturing practices are requirements established by the Food and Drug Administration.
sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
8. Which of the following is an example of an unacceptable record-keeping procedure?
sw sw sw sw sw sw sw sw sw sw sw
a. Using dittos in columns to save time sw sw sw sw sw sw
b. Recording the date and initials next to a correction sw sw sw sw sw sw sw sw
c. Not deleting the original entry when making a correction
sw sw sw sw sw sw sw sw
d. Always using permanent ink on all records sw sw sw sw sw sw
ANS: A s w
All records must be clearly written. Dittos are unacceptable.
sw sw sw sw sw sw sw sw
DIF: Level 1 sw
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be helpful, she carefully rec
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
orded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedure?
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
a. Yes; all results must be recorded regardless of who did the test.
sw sw sw sw sw sw sw sw sw sw sw
b. No; she should have brought the error to the technologist’s attention.
sw sw sw sw sw sw sw sw sw sw
c. Yes; because she used the other technologist’s initials.
sw sw sw sw sw sw sw
d. Yes; as long as she records the result in pencil. sw sw sw sw sw sw sw sw sw
ANS: B s w
This is an example of poor record keeping; results must be recorded when the test is performed and by the person doing the test.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 3 sw
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
a. preventive maintenance has not been performed on the cell washer. sw sw sw sw sw sw sw sw sw
b. the technologist performing the test was never trained.
sw sw sw sw sw sw sw
c. the reagents used were improperly stored. sw sw sw sw sw
d. All of the above sw sw sw
ANS: D s w
Training, equipment maintenance, and reagent quality can affect quality control.
sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
11. All of the following are true regarding competency testing except:
sw sw sw sw sw sw sw sw sw
a. it must be performed following training.
sw sw sw sw sw
b. it must be performed on an annual basis.
sw sw sw sw sw sw sw
c. it is required only if the technologist has no experience.
sw sw sw sw sw sw sw sw sw
d. retraining is required if there is a failure in competency testing. sw sw sw sw sw sw sw sw sw sw
ANS: C s w
All employees must have competency testing following training and annually thereafter. If there is a failure in competency testing, retrainin
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
g is required.
sw sw
DIF: Level 2 sw
12. Which of the following organizations are involved in the regulation of blood banks?
sw sw sw sw sw sw sw sw sw sw sw sw
a. The Joint Commission sw sw
b. AABB
c. College of American Pathologists sw sw sw
d. Food and Drug Administration sw sw sw
ANS: D s w
The Food and Drug Administration regulates blood banks, whereas the other organizations are involved in accreditation.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 1 sw
13. All of the following are responsibilities of the quality assurance department of a blood bank except:
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
a. performing internal audits. sw sw
b. performing quality control. sw sw
c. reviewing standard operating procedures. sw sw sw
d. reviewing and approving training programs. sw sw sw sw
ANS: B s w
Quality control is performed in the laboratory, not by the quality assurance department.
sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level 2 sw
Copyright © 2021, Elsevier Inc. All rights reserved.
sw sw sw sw sw sw sw 2
, 14. The zstandard zoperating zprocedure zis za zdocument zthat:
sw sw sw sw sw sw sw
a. helps zachieve zconsistency zof zresults. sw sw sw sw
b. may zbe zsubstituted zwith zpackage zinserts. sw sw sw sw sw
c. is znecessary zonly zfor ztraining znew zemployees.
sw sw sw sw sw sw
d. must zbe zvery zdetailed zto zbe zaccurate. sw sw w
s sw sw sw
ANS: s w z s w A
Standard zoperating zprocedures zare zwritten zprocedures zthat zhelp zachieve zconsistency zand zshould zbe zclear zand zconcise.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level z2 sw
15. Employee ztraining ztakes zplace: sw sw sw
a. after zhiring zand zfollowing zimplementation zof znew zprocedures.
sw sw sw sw sw sw sw
b. following zcompetency zassessment. w
s w
s
c. only zfor znew zinexperienced zemployees. sw sw sw sw
d. as zprocedures zare zvalidated. sw sw sw
ANS: s w z s w A
Training zoccurs zwith zall znew zemployees zregardless zof ztheir zexperience zand zfollowing zimplementation zof znew zprocedures.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level z1 sw
16. Plans zthat zprovide zthe zframework zfor zestablishing zquality zassurance zin zan zorganization zare:
sw sw sw sw sw sw sw sw sw sw sw sw
a. current zgood zmanufacturing zpractices. sw sw sw
b. standard zoperating zprocedures. sw sw
c. change zcontrol zplan. sw sw
d. continuous zquality zimprovement zplan. sw sw sw
ANS: s w z s w D
The ztotal zquality zmanagement zor zcontinuous zquality zimprovement zplan zare zpart zof zthe zquality zassurance zprogram zin zan zorganization
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
.
DIF: Level z1 sw
17. A zfacility zdoes znot zvalidate za zrefrigerator zbefore zuse. zWhat zis za zpotential zoutcome?
sw sw sw sw sw sw sw sw sw sw sw sw sw
a. Thezfacilityzis zin zviolation zof zcurrent zgood zmanufacturing zpractices zand zco
w
s w
s w
s w
s w
s w
s w
s w
s w
s sw sw
uld zbe zcited zby zthe zFood zand zDrug zAdministration.
sw sw sw sw sw sw sw sw
b. The zfacility zis zin zcompliance zif zthe zequipment zfunctions zproperly.
sw sw sw sw sw sw sw sw sw
c. The zfacility zis zin zcompliance zif zthe zblood zproducts zstored zin zit zare znot ztransfused.
sw w
s sw sw sw sw sw sw sw sw sw sw sw sw
d. The zfacility zis zin zviolation zof zAABB zand zmay zno zlonger zbe zmembers.
w
s w
s sw sw sw sw sw sw w
s sw sw sw
ANS: s w z s w A
Validation zof zequipment zis za zcurrent zgood zmanufacturing zpractice, zwhich zis za zlegal zrequirement zestablished zby zthe zFood zand zDrug zA
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw w
s sw sw sw w
s
dministration.
DIF: Level z2 sw
MULTIPLEzRESPONSE
1. In za zroutine zaudit zof za zfacilities zblood zcollection zarea, zthe zquality zassurance zdepartment zfound zthat zthe zblood zbags zuse
sw sw sw sw sw sw sw sw sw sw sw w
s sw sw sw sw sw sw sw
d zon zthat zparticular zday zhad zexpired. zWhat zis zthe zappropriate zcourse zof zaction? z(Select zall zthat zapply.)
sw sw sw sw w
s sw sw sw sw sw sw sw sw sw sw sw sw
a. Initiatezazrootzcausezanalysis zand zquarantine zthe zbloodzcollected zin zthe zex w
s w
s w
s w
s w
s sw sw sw w
s w
s sw sw
pired zbags. w
s
b. Notify zthe zFDA zsince zthe zexpired zbags zwere zdistributed. w
s sw sw sw sw sw sw sw
c. Change zthe zexpiration zdate zon zthe zbags zto zavoid zlegal zissues. sw sw sw sw sw sw sw sw sw sw
d. Firezthezdonorzroomzsupervisor, zand zdiscard zthezblood zcollected zin zthe zex
w
s w
s w
s w
s sw w
s w
s w
s w
s w
s w
s sw
pired zbags. w
s
ANS: s w z s w A, zB w
s
A zroot zcause zanalysis zwill zdetermine zthe zfactors zthat zcontributed zto zthe zerror zand zresult zin za zplan zto zprevent zfurther zerrors.
sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw
DIF: Level z3 sw
2. Several zunits zwere zreleased zto za zhospital zbyzmistake zbefore zall zviral zmarker ztesting zwas zcompleted. zWhat zis zthe zapp
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ropriate zcourse zof zaction? z(Select zall zthat zapply.)
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a. The zerror zis zreportable, zand zthe zFood zand zDrug zAdministration zmust zbe zcontacted.
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b. Call zthe zhospital zand zrequest za zquarantine zof zthe zremaining zproducts zin zinventory.
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c. Perform zazroot zcausezanalysis zand, zifzthezunits zare zfound zto zbeznegative, zrep w
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s sw w
s w
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s w
s w
s w
s w
s w
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ort zthe ztest zresult zto zthe zhospital.
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d. Recall zonly zthe zunits zthat zare zpositive zfor zviral zmarkers. sw sw sw sw sw sw sw sw sw
ANS: s w z s w A, zB w
s
Release zof zuntested zunits zis za zreportable zerror zto zthe zFood zand zDrug zAdministration zand zthe zhospital zmust zbe znotified zto zquarantine z
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s sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw sw w
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any zremaining zproducts zpending zcompletion zof ztest zresults.
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DIF: Level z3 sw
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