Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank H
g g g g g g g g g g g g g g g g
, ANS: D g
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to
g g g g g g g g g g g g g g g g g
cleaning.
g
DIF: Level 2 g
3. Personal protective equipment includes:
g g g
a. safety glasses. g
b. splash barriers. g
c. masks.
d. All of the above g g g
ANS: D g
Safety glasses, splash barriers, and masks are types of personal protective devices.
g g g g g g g g g g g
DIF: Level 1 g
4. At what point in the employment process should safety training take place?
g g g g g g g g g g g
a. During orientation and training g g g
b. Following lab training when employees are more familiar with their
g g g g g g g g g
responsibilities
g
c. Following the employees’ first evaluation g g g g
d. Before independent work is permitted and annually thereafter
g g g g g g g
ANS: D g
The Occupation Safety and Health Administration requires safety training before independent work is p
g g g g g g g g g g g g g
thereafter.
g
DIF: Level 1 g
5. In safety training, employees must become familiar with all of the following except:
g g g g g g g g g g g g
a. tasks that have an infectious risk.
g g g g g
b. limits of protective clothing and equipment.
g g g g g
c. the appropriate action to take if exposure occurs.
g g g g g g g
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
g g g g g g g g g g
ANS: D g
The Occupational Safety and Health Administration requirements include all of those listed except car
g g g g g g g g g g g g g
DIF: Level 1 g
6. Blood irradiators require all of the following safety procedures except:
g g g g g g g g g
a. proper training. g
b. that the user have a degree in radiology.
g g g g g g g
c. equipment leak detection. g g
d. personal protective equipment. g g
ANS: B g
Blood bank and transfusion service technologists require training but not a degree to use a blood irradia
g g g g g g g g g g g g g g g g
DIF: Level 2 g
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
g g g g g g g g g g
a. GMPs are legal requirements established by the Food and Drug Administration.
g g g g g g g g g g
b. GMPs are optional guidelines written by the AABB.g g g g g g g
c. GMPs are required only by pharmaceutical companies.
g g g g g g
d. GMPs are part of the quality control requirements for blood products.
g g g g g g g g g g
ANS: A g
Good manufacturing practices are requirements established by the Food and Drug Administration.
g g g g g g g g g g g
DIF: Level 1 g
8. Which of the following is an example of an unacceptable record-keeping procedure?
g g g g g g g g g g g
a. Using dittos in columns to save time g g g g g g
b. Recording the date and initials next to a correction g g g g g g g g
c. Not deleting the original entry when making a correction
g g g g g g g g
d. Always using permanent ink on all records g g g g g g
ANS: A g
All records must be clearly written. Dittos are unacceptable.
g g g g g g g g
DIF: Level 1 g
9. A technologist in training noticed that the person training her had not recorded the results of a test. To b
g g g g g g g g g g g g g g g g g g g
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable proce
g g g g g g g g g g g g g g g g g g
a. Yes; all results must be recorded regardless of who did the test.
g g g g g g g g g g g
b. No; she should have brought the error to the technologist’s attention.
g g g g g g g g g g
c. Yes; because she used the other technologist’s initials.
g g g g g g g
d. Yes; as long as she records the result in pencil.
g g g g g g g g g
ANS: B g
This is an example of poor record keeping; results must be recorded when the test is performed and by
g g g g g g g g g g g g g g g g g g
DIF: Level 3 g
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
g g g g g g g g g g g g g g g
a. preventive maintenance has not been performed on the cell washer. g g g g g g g g g
b. the technologist performing the test was never trained.
g g g g g g g
c. the reagents used were improperly stored.
g g g g g
d. All of the above g g g
ANS: D g
Training, equipment maintenance, and reagent quality can affect quality control.
g g g g g g g g g
DIF: Level 2 g
11. All of the following are true regarding competency testing except:
g g g g g g g g g
a. it must be performed following training.
g g g g g
b. it must be performed on an annual basis.
g g g g g g g
c. it is required only if the technologist has no experience.
g g g g g g g g g
d. retraining is required if there is a failure in competency testing. g g g g g g g g g g
ANS: C g
All employees must have competency testing following training and annually thereafter. If there is a fai
g g g g g g g g g g g g g g g
retraining is required.
g g g
DIF: Level 2 g
12. Which of the following organizations are involved in the regulation of blood banks?
g g g g g g g g g g g g
a. The Joint Commission g g
b. AABB
c. College of American Pathologists g g g
, 14. The standard operating procedure is a document that:
g g g g g g g
a. helps achieve consistency of results.
g g g g
b. may be substituted with package inserts.
g g g g g
c. is necessary only for training new employees.
g g g g g g
d. must be very detailed to be accurate.
g g g g g g
ANS: A g
Standard operating procedures are written procedures that help achieve consistency and should be clea
g g g g g g g g g g g g g
DIF: Level 2 g
15. Employee training takes place: g g g
a. after hiring and following implementation of new procedures.
g g g g g g g
b. following competency assessment. g g
c. only for new inexperienced employees.
g g g g
d. as procedures are validated.
g g g
ANS: A g
Training occurs with all new employees regardless of their experience and following implementation o
g g g g g g g g g g g g g
DIF: Level 1 g
16. Plans that provide the framework for establishing quality assurance in an organization are:
g g g g g g g g g g g g
a. current good manufacturing practices. g g g
b. standard operating procedures. g g
c. change control plan. g g
d. continuous quality improvement plan. g g g
ANS: D g
The total quality management or continuous quality improvement plan are part of the quality assurance
g g g g g g g g g g g g g g
DIF: Level 1 g
17. A facility does not validate a refrigerator before use. What is a potential outcome?
g g g g g g g g g g g g g
a. The facility is in violation of current good manufacturing practices and could be
g g g g g g g g g g g g
cited by the Food and Drug Administration.
g g g g g g g
b. The facility is in compliance if the equipment functions properly.
g g g g g g g g g
c. The facility is in compliance if the blood products stored in it are not transfused.
g g g g g g g g g g g g g g
d. The facility is in violation of AABB and may no longer be members.
g g g g g g g g g g g g
ANS: A g
Validation of equipment is a current good manufacturing practice, which is a legal requirement establis
g g g g g g g g g g g g g g
Administration.
g
DIF: Level 2 g
MULTIPLE RESPONSE g
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the b
g g g g g g g g g g g g g g g g g
particular day had expired. What is the appropriate course of action? (Select all that apply.)
g g g g g g g g g g g g g g g
a. Initiate a root cause analysis and quarantine the blood collected in the expired
g g g g g g g g g g g g
bags.g
b. Notify the FDA since the expired bags were distributed.
g g g g g g g g
c. Change the expiration date on the bags to avoid legal issues.
g g g g g g g g g g
d. Fire the donor room supervisor, and discard the blood collected in the expired
g g g g g g g g g g g g
bags.g
ANS: A, B g g
A root cause analysis will determine the factors that contributed to the error and result in a plan to prev
g g g g g g g g g g g g g g g g g g g
DIF: Level 3 g
g g g g g g g g g g g g g g g g
, ANS: D g
Methods of transporting the lab coat and the risk of contamination do not permit health care workers to
g g g g g g g g g g g g g g g g g
cleaning.
g
DIF: Level 2 g
3. Personal protective equipment includes:
g g g
a. safety glasses. g
b. splash barriers. g
c. masks.
d. All of the above g g g
ANS: D g
Safety glasses, splash barriers, and masks are types of personal protective devices.
g g g g g g g g g g g
DIF: Level 1 g
4. At what point in the employment process should safety training take place?
g g g g g g g g g g g
a. During orientation and training g g g
b. Following lab training when employees are more familiar with their
g g g g g g g g g
responsibilities
g
c. Following the employees’ first evaluation g g g g
d. Before independent work is permitted and annually thereafter
g g g g g g g
ANS: D g
The Occupation Safety and Health Administration requires safety training before independent work is p
g g g g g g g g g g g g g
thereafter.
g
DIF: Level 1 g
5. In safety training, employees must become familiar with all of the following except:
g g g g g g g g g g g g
a. tasks that have an infectious risk.
g g g g g
b. limits of protective clothing and equipment.
g g g g g
c. the appropriate action to take if exposure occurs.
g g g g g g g
d. how to perform cardiopulmonary resuscitation on a donor or other employee.
g g g g g g g g g g
ANS: D g
The Occupational Safety and Health Administration requirements include all of those listed except car
g g g g g g g g g g g g g
DIF: Level 1 g
6. Blood irradiators require all of the following safety procedures except:
g g g g g g g g g
a. proper training. g
b. that the user have a degree in radiology.
g g g g g g g
c. equipment leak detection. g g
d. personal protective equipment. g g
ANS: B g
Blood bank and transfusion service technologists require training but not a degree to use a blood irradia
g g g g g g g g g g g g g g g g
DIF: Level 2 g
, 7. Which of the following is true regarding good manufacturing practices (GMPs)?
g g g g g g g g g g
a. GMPs are legal requirements established by the Food and Drug Administration.
g g g g g g g g g g
b. GMPs are optional guidelines written by the AABB.g g g g g g g
c. GMPs are required only by pharmaceutical companies.
g g g g g g
d. GMPs are part of the quality control requirements for blood products.
g g g g g g g g g g
ANS: A g
Good manufacturing practices are requirements established by the Food and Drug Administration.
g g g g g g g g g g g
DIF: Level 1 g
8. Which of the following is an example of an unacceptable record-keeping procedure?
g g g g g g g g g g g
a. Using dittos in columns to save time g g g g g g
b. Recording the date and initials next to a correction g g g g g g g g
c. Not deleting the original entry when making a correction
g g g g g g g g
d. Always using permanent ink on all records g g g g g g
ANS: A g
All records must be clearly written. Dittos are unacceptable.
g g g g g g g g
DIF: Level 1 g
9. A technologist in training noticed that the person training her had not recorded the results of a test. To b
g g g g g g g g g g g g g g g g g g g
recorded the results she saw at a later time, using the technologist’s initials. Is this an acceptable proce
g g g g g g g g g g g g g g g g g g
a. Yes; all results must be recorded regardless of who did the test.
g g g g g g g g g g g
b. No; she should have brought the error to the technologist’s attention.
g g g g g g g g g g
c. Yes; because she used the other technologist’s initials.
g g g g g g g
d. Yes; as long as she records the result in pencil.
g g g g g g g g g
ANS: B g
This is an example of poor record keeping; results must be recorded when the test is performed and by
g g g g g g g g g g g g g g g g g g
DIF: Level 3 g
10. Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:
g g g g g g g g g g g g g g g
a. preventive maintenance has not been performed on the cell washer. g g g g g g g g g
b. the technologist performing the test was never trained.
g g g g g g g
c. the reagents used were improperly stored.
g g g g g
d. All of the above g g g
ANS: D g
Training, equipment maintenance, and reagent quality can affect quality control.
g g g g g g g g g
DIF: Level 2 g
11. All of the following are true regarding competency testing except:
g g g g g g g g g
a. it must be performed following training.
g g g g g
b. it must be performed on an annual basis.
g g g g g g g
c. it is required only if the technologist has no experience.
g g g g g g g g g
d. retraining is required if there is a failure in competency testing. g g g g g g g g g g
ANS: C g
All employees must have competency testing following training and annually thereafter. If there is a fai
g g g g g g g g g g g g g g g
retraining is required.
g g g
DIF: Level 2 g
12. Which of the following organizations are involved in the regulation of blood banks?
g g g g g g g g g g g g
a. The Joint Commission g g
b. AABB
c. College of American Pathologists g g g
, 14. The standard operating procedure is a document that:
g g g g g g g
a. helps achieve consistency of results.
g g g g
b. may be substituted with package inserts.
g g g g g
c. is necessary only for training new employees.
g g g g g g
d. must be very detailed to be accurate.
g g g g g g
ANS: A g
Standard operating procedures are written procedures that help achieve consistency and should be clea
g g g g g g g g g g g g g
DIF: Level 2 g
15. Employee training takes place: g g g
a. after hiring and following implementation of new procedures.
g g g g g g g
b. following competency assessment. g g
c. only for new inexperienced employees.
g g g g
d. as procedures are validated.
g g g
ANS: A g
Training occurs with all new employees regardless of their experience and following implementation o
g g g g g g g g g g g g g
DIF: Level 1 g
16. Plans that provide the framework for establishing quality assurance in an organization are:
g g g g g g g g g g g g
a. current good manufacturing practices. g g g
b. standard operating procedures. g g
c. change control plan. g g
d. continuous quality improvement plan. g g g
ANS: D g
The total quality management or continuous quality improvement plan are part of the quality assurance
g g g g g g g g g g g g g g
DIF: Level 1 g
17. A facility does not validate a refrigerator before use. What is a potential outcome?
g g g g g g g g g g g g g
a. The facility is in violation of current good manufacturing practices and could be
g g g g g g g g g g g g
cited by the Food and Drug Administration.
g g g g g g g
b. The facility is in compliance if the equipment functions properly.
g g g g g g g g g
c. The facility is in compliance if the blood products stored in it are not transfused.
g g g g g g g g g g g g g g
d. The facility is in violation of AABB and may no longer be members.
g g g g g g g g g g g g
ANS: A g
Validation of equipment is a current good manufacturing practice, which is a legal requirement establis
g g g g g g g g g g g g g g
Administration.
g
DIF: Level 2 g
MULTIPLE RESPONSE g
1. In a routine audit of a facilities blood collection area, the quality assurance department found that the b
g g g g g g g g g g g g g g g g g
particular day had expired. What is the appropriate course of action? (Select all that apply.)
g g g g g g g g g g g g g g g
a. Initiate a root cause analysis and quarantine the blood collected in the expired
g g g g g g g g g g g g
bags.g
b. Notify the FDA since the expired bags were distributed.
g g g g g g g g
c. Change the expiration date on the bags to avoid legal issues.
g g g g g g g g g g
d. Fire the donor room supervisor, and discard the blood collected in the expired
g g g g g g g g g g g g
bags.g
ANS: A, B g g
A root cause analysis will determine the factors that contributed to the error and result in a plan to prev
g g g g g g g g g g g g g g g g g g g
DIF: Level 3 g
