TESTBANK n
BASIC &APPLIED CONCEPTS OFBLOOD 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 too
n n n n n n n n n n n n n n n n n n
n returned by the laboratory’s laundry service. Is this practice acceptable?
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 bring
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
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
ANS: D 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 help
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 pe
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 failure i
n n n n n n n n n n n n n n n n
is required.
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 and
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 new
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 pro
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 b
n 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 b
n 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 fu
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 OFBLOOD 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 too
n n n n n n n n n n n n n n n n n n
n returned by the laboratory’s laundry service. Is this practice acceptable?
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 bring
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
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
ANS: D 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 help
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 pe
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 failure i
n n n n n n n n n n n n n n n n
is required.
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 and
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 new
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 pro
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 b
n 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 b
n 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 fu
n n n n n n n n n n n n n n n n n n n n
DIF: Level 3 n
