TESTBANK N
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION
N N N N N N N N
PRACTICES 5TH EDITION
N N N
Paula R. Howard
N N
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood
N N N N N N N N N N N N N N N
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
N N N N N N N N N N N N
MULTIPLE CHOICE N
1. Biosafety levels determine: N N
a. on what floor certain infectious disease testing can be performed.
N N N N N N N N N
b. the degree of risk for certain areas of a health care facility to exposure to
N N N N N N N N N N N N N N
infectious diseases.
N N
c. the amount of ventilation required in a transfusion service.
N N N N N N N N
d. how many biohazardous waste containers a laboratory must have.
N N N N N N N N
ANS: B N
OSHA defines biosafety levels based on potential exposure to infectious material.
N N N N N N N N N N
DIF: Level 1 N
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had t
N N N N N N N N N N N N N N N N N N
N was returned by the laboratory’s laundry service. Is this practice acceptable?
N N N N N N N N N N
a. Yes, if she uses 10% bleach N N N N N
b. Yes, if she clears it with her supervisor N N N N N N N
c. Yes, as long as she removes the coat and does not wear it home
N N N N N N N N N N N N N
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
N N N N N N N N N N N N N N
removed N
ANS: D N
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to brin
N N N N N N N N N N N N N N N N N N
DIF: Level 2 N
3. Personal protective equipment includes: N N N
a. safety glasses. N
b. splash barriers. N
c. masks.
d. All of the above N N N
ANS: D N
Safety glasses, splash barriers, and masks are types of personal protective devices.
N N N N N N N N N N N
DIF: Level 1 N
4. At what point in the employment process should safety training take place?
N N N N N N N N N N N
a. During orientation and training N N N
b. Following lab training when employees are more familiar with their N N N N N N N N N
responsibilities
N
c. Following the employees’ first evaluation N N N N
d. Before independent work is permitted and annually thereafter
N N N N N N N
ANS: D N
The Occupation Safety and Health Administration requires safety training before independent work is perm
N N N N N N N N N N N N N
thereafter.
N
DIF: Level 1 N
5. In safety training, employees must become familiar with all of the following except:
N N N N N N N N N N N N
a. tasks that have an infectious risk. N N N N N
b. limits of protective clothing and equipment. N N N N N
c. the appropriate action to take if exposure occurs.
N N N N N N N
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
N N N N N N N N N N
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
N N N N N N N N N N
a. GMPs are legal requirements established by the Food and Drug Administration.
N N N N N N N N N N
b. GMPs are optional guidelines written by the AABB. N N N N N N N
c. GMPs are required only by pharmaceutical companies.
N N N N N N
d. GMPs are part of the quality control requirements for blood products.
N N N N N N N N N N
ANS: A N
Good manufacturing practices are requirements established by the Food and Drug Administration.
N N N N N N N N N N N
DIF: Level 1 N
8. Which of the following is an example of an unacceptable record-keeping procedure?
N N N N N N N N N N N
a. Using dittos in columns to save time N N N N N N
b. Recording the date and initials next to a correction N N N N N N N N
c. Not deleting the original entry when making a correction
N N N N N N N N
d. Always using permanent ink on all records N N N N N N
ANS: A N
All records must be clearly written. Dittos are unacceptable.
N N N N N N N N
DIF: Level 1 N
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be he
N N N N N N N N N N N N N N N N N N N N
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedure
N N N N N N N N N N N N N N N N N N
a. Yes; all results must be recorded regardless of who did the test.
N N N N N N N N N N N
b. No; she should have brought the error to the technologist’s attention.
N N N N N N N N N N
c. Yes; because she used the other technologist’s initials.
N N N N N N N
d. Yes; as long as she records the result in pencil.
N N N N N N N N N
ANS: B N
This is an example of poor record keeping; results must be recorded when the test is performed and by the
N N N N N N N N N N N N N N N N N N N N
DIF: Level 3 N
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
N N N N N N N N N N N N N N N
a. preventive maintenance has not been performed on the cell washer. N N N N N N N N N
b. the technologist performing the test was never trained.
N N N N N N N
c. the reagents used were improperly stored.
N N N N N
d. All of the above N N N
ANS: D N
Training, equipment maintenance, and reagent quality can affect quality control.
N N N N N N N N N
DIF: Level 2 N
11. All of the following are true regarding competency testing except:
N N N N N N N N N
a. it must be performed following training.
N N N N N
b. it must be performed on an annual basis.
N N N N N N N
c. it is required only if the technologist has no experience.
N N N N N N N N N
d. retraining is required if there is a failure in competency testing. N N N N N N N N N N
ANS: C N
All employees must have competency testing following training and annually thereafter. If there is a failur
N N N N N N N N N N N N N N N
retraining is required.
N N N
DIF: Level 2 N
12. Which of the following organizations are involved in the regulation of blood banks?
N N N N N N N N N N N N
a. The Joint Commission N N
b. AABB
c. College of American Pathologists N N N
, 14. The standard operating procedure is a document that:
N N N N N N N
a. helps achieve consistency of results. N N N N
b. may be substituted with package inserts.
N N N N N
c. is necessary only for training new employees.
N N N N N N
d. must be very detailed to be accurate.
N N N N N N
ANS: A N
Standard operating procedures are written procedures that help achieve consistency and should be clear an
N N N N N N N N N N N N N N
DIF: Level 2 N
15. Employee training takes place: N N N
a. after hiring and following implementation of new procedures.
N N N N N N N
b. following competency assessment. N N
c. only for new inexperienced employees.
N N N N
d. as procedures are validated.
N N N
ANS: A N
Training occurs with all new employees regardless of their experience and following implementation of n
N N N N N N N N N N N N N N
DIF: Level 1 N
16. Plans that provide the framework for establishing quality assurance in an organization are:
N N N N N N N N N N N N
a. current good manufacturing practices. N N N
b. standard operating procedures. N N
c. change control plan. N N
d. continuous quality improvement plan. N N N
ANS: D N
The total quality management or continuous quality improvement plan are part of the quality assurance pr
N N N N N N N N N N N N N N N
DIF: Level 1 N
17. A facility does not validate a refrigerator before use. What is a potential outcome?
N N N N N N N N N N N N N
a. The facility is in violation of current good manufacturing practices and could be
N N N N N N N N N N N N
cited by the Food and Drug Administration.
N N N N N N N
b. The facility is in compliance if the equipment functions properly.
N N N N N N N N N
c. The facility is in compliance if the blood products stored in it are not transfused.
N N N N N N N N N N N N N N
d. The facility is in violation of AABB and may no longer be members.
N N N N N N N N N N N N
ANS: A N
Validation of equipment is a current good manufacturing practice, which is a legal requirement established
N N N N N N N N N N N N N N
Administration.
N
DIF: Level 2 N
MULTIPLE RESPONSE N
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the blood
N N N N N N N N N N N N N N N N N
particular day had expired. What is the appropriate course of action? (Select all that apply.)
N N N N N N N N N N N N N N N
a. Initiate a root cause analysis and quarantine the blood collected in the expired
N N N N N N N N N N N N
bags. N
b. Notify the FDA since the expired bags were distributed.
N N N N N N N N
c. Change the expiration date on the bags to avoid legal issues.
N N N N N N N N N N
d. Fire the donor room supervisor, and discard the blood collected in the expired
N N N N N N N N N N N N
bags. N
ANS: A, B N N
A root cause analysis will determine the factors that contributed to the error and result in a plan to prevent f
N N N N N N N N N N N N N N N N N N N N
DIF: Level 3 N
BASIC & APPLIED CONCEPTS OF BLOOD BANKING AND TRANSFUSION
N N N N N N N N
PRACTICES 5TH EDITION
N N N
Paula R. Howard
N N
,Chapter 01: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood
N N N N N N N N N N N N N N N
Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition
N N N N N N N N N N N N
MULTIPLE CHOICE N
1. Biosafety levels determine: N N
a. on what floor certain infectious disease testing can be performed.
N N N N N N N N N
b. the degree of risk for certain areas of a health care facility to exposure to
N N N N N N N N N N N N N N
infectious diseases.
N N
c. the amount of ventilation required in a transfusion service.
N N N N N N N N
d. how many biohazardous waste containers a laboratory must have.
N N N N N N N N
ANS: B N
OSHA defines biosafety levels based on potential exposure to infectious material.
N N N N N N N N N N
DIF: Level 1 N
2. A laboratory technologist decided she would like to bring her lab coat home for laundering because it had t
N N N N N N N N N N N N N N N N N N
N was returned by the laboratory’s laundry service. Is this practice acceptable?
N N N N N N N N N N
a. Yes, if she uses 10% bleach N N N N N
b. Yes, if she clears it with her supervisor N N N N N N N
c. Yes, as long as she removes the coat and does not wear it home
N N N N N N N N N N N N N
d. No, because the laboratory is a biosafety level 2, and lab coats may not be
N N N N N N N N N N N N N N
removed N
ANS: D N
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to brin
N N N N N N N N N N N N N N N N N N
DIF: Level 2 N
3. Personal protective equipment includes: N N N
a. safety glasses. N
b. splash barriers. N
c. masks.
d. All of the above N N N
ANS: D N
Safety glasses, splash barriers, and masks are types of personal protective devices.
N N N N N N N N N N N
DIF: Level 1 N
4. At what point in the employment process should safety training take place?
N N N N N N N N N N N
a. During orientation and training N N N
b. Following lab training when employees are more familiar with their N N N N N N N N N
responsibilities
N
c. Following the employees’ first evaluation N N N N
d. Before independent work is permitted and annually thereafter
N N N N N N N
ANS: D N
The Occupation Safety and Health Administration requires safety training before independent work is perm
N N N N N N N N N N N N N
thereafter.
N
DIF: Level 1 N
5. In safety training, employees must become familiar with all of the following except:
N N N N N N N N N N N N
a. tasks that have an infectious risk. N N N N N
b. limits of protective clothing and equipment. N N N N N
c. the appropriate action to take if exposure occurs.
N N N N N N N
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
N N N N N N N N N N
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
N N N N N N N N N N
a. GMPs are legal requirements established by the Food and Drug Administration.
N N N N N N N N N N
b. GMPs are optional guidelines written by the AABB. N N N N N N N
c. GMPs are required only by pharmaceutical companies.
N N N N N N
d. GMPs are part of the quality control requirements for blood products.
N N N N N N N N N N
ANS: A N
Good manufacturing practices are requirements established by the Food and Drug Administration.
N N N N N N N N N N N
DIF: Level 1 N
8. Which of the following is an example of an unacceptable record-keeping procedure?
N N N N N N N N N N N
a. Using dittos in columns to save time N N N N N N
b. Recording the date and initials next to a correction N N N N N N N N
c. Not deleting the original entry when making a correction
N N N N N N N N
d. Always using permanent ink on all records N N N N N N
ANS: A N
All records must be clearly written. Dittos are unacceptable.
N N N N N N N N
DIF: Level 1 N
9. A technologist in training noticed that the person training her had not recorded the results of a test. To be he
N N N N N N N N N N N N N N N N N N N N
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable procedure
N N N N N N N N N N N N N N N N N N
a. Yes; all results must be recorded regardless of who did the test.
N N N N N N N N N N N
b. No; she should have brought the error to the technologist’s attention.
N N N N N N N N N N
c. Yes; because she used the other technologist’s initials.
N N N N N N N
d. Yes; as long as she records the result in pencil.
N N N N N N N N N
ANS: B N
This is an example of poor record keeping; results must be recorded when the test is performed and by the
N N N N N N N N N N N N N N N N N N N N
DIF: Level 3 N
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
N N N N N N N N N N N N N N N
a. preventive maintenance has not been performed on the cell washer. N N N N N N N N N
b. the technologist performing the test was never trained.
N N N N N N N
c. the reagents used were improperly stored.
N N N N N
d. All of the above N N N
ANS: D N
Training, equipment maintenance, and reagent quality can affect quality control.
N N N N N N N N N
DIF: Level 2 N
11. All of the following are true regarding competency testing except:
N N N N N N N N N
a. it must be performed following training.
N N N N N
b. it must be performed on an annual basis.
N N N N N N N
c. it is required only if the technologist has no experience.
N N N N N N N N N
d. retraining is required if there is a failure in competency testing. N N N N N N N N N N
ANS: C N
All employees must have competency testing following training and annually thereafter. If there is a failur
N N N N N N N N N N N N N N N
retraining is required.
N N N
DIF: Level 2 N
12. Which of the following organizations are involved in the regulation of blood banks?
N N N N N N N N N N N N
a. The Joint Commission N N
b. AABB
c. College of American Pathologists N N N
, 14. The standard operating procedure is a document that:
N N N N N N N
a. helps achieve consistency of results. N N N N
b. may be substituted with package inserts.
N N N N N
c. is necessary only for training new employees.
N N N N N N
d. must be very detailed to be accurate.
N N N N N N
ANS: A N
Standard operating procedures are written procedures that help achieve consistency and should be clear an
N N N N N N N N N N N N N N
DIF: Level 2 N
15. Employee training takes place: N N N
a. after hiring and following implementation of new procedures.
N N N N N N N
b. following competency assessment. N N
c. only for new inexperienced employees.
N N N N
d. as procedures are validated.
N N N
ANS: A N
Training occurs with all new employees regardless of their experience and following implementation of n
N N N N N N N N N N N N N N
DIF: Level 1 N
16. Plans that provide the framework for establishing quality assurance in an organization are:
N N N N N N N N N N N N
a. current good manufacturing practices. N N N
b. standard operating procedures. N N
c. change control plan. N N
d. continuous quality improvement plan. N N N
ANS: D N
The total quality management or continuous quality improvement plan are part of the quality assurance pr
N N N N N N N N N N N N N N N
DIF: Level 1 N
17. A facility does not validate a refrigerator before use. What is a potential outcome?
N N N N N N N N N N N N N
a. The facility is in violation of current good manufacturing practices and could be
N N N N N N N N N N N N
cited by the Food and Drug Administration.
N N N N N N N
b. The facility is in compliance if the equipment functions properly.
N N N N N N N N N
c. The facility is in compliance if the blood products stored in it are not transfused.
N N N N N N N N N N N N N N
d. The facility is in violation of AABB and may no longer be members.
N N N N N N N N N N N N
ANS: A N
Validation of equipment is a current good manufacturing practice, which is a legal requirement established
N N N N N N N N N N N N N N
Administration.
N
DIF: Level 2 N
MULTIPLE RESPONSE N
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the blood
N N N N N N N N N N N N N N N N N
particular day had expired. What is the appropriate course of action? (Select all that apply.)
N N N N N N N N N N N N N N N
a. Initiate a root cause analysis and quarantine the blood collected in the expired
N N N N N N N N N N N N
bags. N
b. Notify the FDA since the expired bags were distributed.
N N N N N N N N
c. Change the expiration date on the bags to avoid legal issues.
N N N N N N N N N N
d. Fire the donor room supervisor, and discard the blood collected in the expired
N N N N N N N N N N N N
bags. N
ANS: A, B N N
A root cause analysis will determine the factors that contributed to the error and result in a plan to prevent f
N N N N N N N N N N N N N N N N N N N N
DIF: Level 3 N
