BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND
TRANSFUSION PRACTICES 4TH 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, 4th
Edition
MULTIPLE CHOICE
1. Which of the following agencies administers the Clinical Laboratory Improvement
Amendments?
a.AABB
b.Centers for Medicare and Medicaid Services
c.OSHA
d.Food and Drug Administration
ANS: B
The Centers for Medicare and Medicaid Services administers CLIA, Medicare, Medicaid, and
HIPAA.
DIF: Level 1 REF: p. 3
2. A laboratory technologist decided she would like to bring her lab coat home for laundering
because it had too many wrinkles when 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 REF: p. 14
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 REF: p. 14
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 thereafter.
DIF: Level 1 REF: p. 17
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 REF: p. 13
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 REF: p. 16
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 REF: p. 5
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 REF: p. 7
9. A ftechnologist fin ftraining fnoticed fthat fthe fperson ftraining fher fhad fnot frecorded fthe
fresults fof fa ftest. fTo fbe f helpful, fshe fcarefully frecorded fthe fresults f she fsaw fat fa f later
ftime, fusing fthe ftechnologist’s f initials. fIs fthis fan facceptable fprocedure?
a. Yes; fall fresults fmust fbe frecorded fregardless fof fwho fdid fthe ftest.
b. No; fshe fshould fhave fbrought fthe ferror fto fthe ftechnologist’s fattention.
c. Yes; fbecause fshe fused fthe fother ftechnologist’s finitials.
d. Yes; fas flong fas fshe frecords fthe fresult fin fpencil.
ANS: f B
This fis fan fexample fof fpoor frecord fkeeping; fresults fmust fbe frecorded fwhen fthe ftest fis
fperformed fand f by fthe fperson fdoing fthe ftest.
DIF: Level f3 REF: f f p. f8
10. Unacceptable fquality fcontrol fresults ffor fthe fantiglobulin ftest fperformed fin ftest ftubes
fmay fbe f noticed f if:
a. preventive fmaintenance fhas fnot fbeen fperformed fon fthe fcell fwasher.
b. the ftechnologist fperforming fthe ftest fwas fnever ftrained.
c. the freagents fused fwere fimproperly fstored.
d. All fof fthe fabove
ANS: f D
Training, fequipment fmaintenance, fand freagent fquality fcan faffect fquality fcontrol.
DIF: Level f2 REF: f f p. f5
11. All fof fthe ffollowing fare ftrue fregarding fcompetency ftesting fexcept:
a. it fmust fbe fperformed ffollowing ftraining.
b. it fmust fbe fperformed fon fan fannual fbasis.
c. it fis frequired fonly fif fthe ftechnologist fhas fno fexperience.
d. retraining fis frequired fif fthere fis fa ffailure fin fcompetency ftesting.
ANS: f C
All femployees fmust fhave fcompetency ftesting ffollowing ftraining fand fannually fthereafter.
fIf fthere f is f a f failure f in fcompetency ftesting, fretraining f is frequired.
DIF: Level f2 REF: f f p. f10
12. Which fof fthe ffollowing forganizations fare finvolved fin fthe fregulation fof fblood fbanks?
a. The fJoint fCommission
b. AABB
c. College fof fAmerican fPathologists
d. Food fand fDrug fAdministration
ANS: f D
The fFood fand fDrug fAdministration fregulates fblood fbanks, fwhereas fthe fother
forganizations fare f involved f in faccreditation.
DIF: Level f1 REF: f f p. f2
,13. All fof fthe ffollowing fare fresponsibilities fof fthe fquality fassurance fdepartment fof fa fblood
fbank
except:
a. performing finternal faudits.
b. performing fquality fcontrol.
c. reviewing fstandard foperating fprocedures.
d. reviewing fand fapproving ftraining fprograms.
ANS: f B
Quality fcontrol fis fperformed fin fthe flaboratory, fnot fby fthe fquality fassurance fdepartment.
DIF: Level f2 REF: f f p. f5
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 f be fclear fand fconcise.
DIF: Level f2 REF: f f p. f8
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
f implementation fof f new fprocedures.
DIF: Level f1 REF: f f p. f10
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 fassurance fprogram f in fan forganization.
DIF: Level f1 REF: f f p. f4
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 f by fthe f Food 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 festablished f by fthe f Food fand fDrug fAdministration.
DIF: Level f2 REF: f f p. f12
18. In fa froutine faudit fof fa ffacilities fblood fcollection farea, fthe fquality fassurance fdepartment
ffound fthat fthe fblood fbags fused fon fthat fparticular fday fhad fexpired. fWhat fis fthe
fappropriate fcourse fof faction?
a. Initiate fa froot fcause fanalysis fand fquarantine fthe fblood fcollected fin fthe
fexpired f bags.
b. Call fthe fFood fand fDrug fAdministration fto freport fthe fincident.
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 f bags.
ANS: f A
A froot fcause fanalysis fwill fdetermine fthe ffactors fthat fcontributed fto fthe ferror fand fresult
fin fa fplan fto fprevent f further ferrors.
DIF: Level f3 REF: f f p. f11
19. Several funits fwere freleased fto fa fhospital fby fmistake fbefore fall fviral fmarker
ftesting fwas fcompleted. fWhat f is fthe fappropriate fcourse fof faction?
a. The ferror fis freportable, fand fthe fFood fand fDrug fAdministration fmust fbe fcontacted.
b. Ask fthe fhospital fto favoid ftransfusion fand fquickly fcomplete fthe ftesting.
c. Perform fa froot fcause fanalysis fand, fif fthe funits fare ffound fto fbe fnegative,
freport fthe ftest fresult fto fthe f hospital.
d. Recall fonly fthe funits fthat fare fpositive ffor fviral fmarkers.
ANS: f A
Release fof funtested funits fis fa freportable ferror fto fthe fFood fand fDrug fAdministration.
DIF: Level f3 REF: f f p. f11
MATCHING
Match fthe fgovernment for faccrediting fagencies fwith fthe fdescription fthat fbest ffits ftheir
fpurpose.
a. Ensures fsafe fand fhealthful fworking fconditions
b. Ensures fthe fsafety fand fefficacy fof fbiologics, fdrugs, fand fdevices
c. Provides fpeer-reviewed faccreditation ffor fhospital flaboratories
d. Professional forganization fthat faccredits fblood fbanks fand ftransfusion fservices
e. Makes frecommendations fto fthe fOccupational fSafety fand fHealth
fAdministration fregarding fthe fprevention fof fdisease ftransmission
1. FDA
, 2. OSHA
3. CDC
4. AABB
5. CAP
1. f B DIF: Level f1
f ANS:
2. f A DIF: Level f1
f ANS:
3. f E DIF: Level f1
f ANS:
4. f D DIF: Level f1
f ANS:
5. f C DIF: Level f1
f ANS:
Match fthe ffollowing fdescriptions fwith fthe fappropriate fterms.
a. The fCAP fsurvey fis fan fexample
b. Systematic fevaluations fto fdetermine fwhether fprocedures fare fbeing ffollowed
c. Testing fto fdetermine fthe faccuracy fand fprecision fof freagents fand fequipment
d. Process fof fstandardizing fan finstrument fagainst fa fknown fvalue
e. Removal fof fproducts ffrom fthe fmarket fthat fmight fcompromise fthe fsafety
fof fthe frecipient
f. Degree fto fwhich fa fmeasurement frepresents fthe ftrue fvalue
g. Establishing fthat fa fspecific fprocess fproduces fan fexpected fresult
h. Evaluation fof fan femployee’s fability fto fperform fa fspecific fskill
i. Investigation fand fidentification fof fthe ffactors fthat fcontributed fto fan ferror
j. Maximizes fthe fduration fof fequipment fand fincreases fthe freliability
fof fthe fequipment
k. System fto fplan fand fimplement fchanges fto fprevent fproblems
6. Root fcause fanalysis
7. Recall
8. Accuracy
9. Validation
10. Calibration
11. Quality fcontrol
12. Proficiency ftest
13. Competency fassessment
14. Change fcontrol
15. Audit
16. Preventive fmaintenance
6. f I DIF: Level f1
f ANS:
7. f E DIF: Level f1
f ANS:
8. f F DIF: Level f1
f ANS:
9. f G DIF: Level f1
f ANS:
10. f D DIF: Level f1
f ANS:
11. f C DIF: Level f1
f ANS: