Question 1

Quality control is the same as quality assurance.

Accepted Answer

A)   True
B)   False

Question 2

A facility does not validate a refrigerator before use. What is a potential outcome?

Accepted Answer

A)   The facility is in violation of current good manufacturing practices and could be cited by the Food and Drug Administration.
B)   The facility is in compliance if the equipment functions properly.
C)   The facility is in compliance if the blood products stored in it are not transfused.
D)   The facility is in violation of AABB and may no longer be members. A

Question 3

Match the following descriptions with the appropriate terms.
-Accuracy

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems

Question 4

Match the following descriptions with the appropriate terms.
-Quality control

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems

Question 5

Match the following descriptions with the appropriate terms.
-Audit

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems

Question 6

Which of the following is an example of an unacceptable record-keeping procedure?

Accepted Answer

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

Question 7

Several units were released to a hospital by mistake before all viral marker testing was completed. What is the appropriate course of action?

Accepted Answer

A)   The error is reportable, and the Food and Drug Administration must be contacted.
B)   Ask the hospital to avoid transfusion and quickly complete the testing.
C)   Perform a root cause analysis and, if the units are found to be negative, report the test result to the hospital.
D)   Recall only the units that are positive for viral markers.

Question 8

Which of the following is true regarding good manufacturing practices (GMPs) ?

Accepted Answer

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.

Question 9

In a routine audit of a facilities blood collection area, the quality assurance department found that the blood bags being used on that particular day had expired. What is the appropriate course of action?

Accepted Answer

A)   Initiate a root cause analysis and quarantine the blood collected in the expired bags.
B)   Call the Food and Drug Administration to report the incidence.
C)   Change the expiration date on the bags to avoid legal issues.
D)   Fire the donor room supervisor, and discard the blood collected in the expired bags.

Question 10

All of the following are true regarding competency testing except:

Accepted Answer

A)   it must be performed following training.
B)   it must be performed on an annual basis.
C)   it is required only if the technologist has no experience.
D)   retraining is required if there is a failure in competency testing.

Question 11

Match the following descriptions with the appropriate terms.
-Competency assessment

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems

Question 12

Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:

Accepted Answer

A)   preventive maintenance has not been performed on the cell washer.
B)   the technologist performing the test was never trained.
C)   the reagents used were improperly stored.
D)   all of the above.

Question 13

A technologist was being trained in a different area of the blood bank and noticed that the person training her had not recorded the results of a test. To be helpful, she carefully recorded the results she saw at a later time, using the technologist's initials. Is this acceptable procedure?

Accepted Answer

A)   Yes; all results must be recorded regardless of who did the test.
B)   No; she should have brought the error to the technologist's attention.
C)   Yes; because she used the other technologist's initials.
D)   Yes; as long as she records the result in pencil.

Question 14

Match the following descriptions with the appropriate terms.
-Root cause analysis

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems

Question 15

Plans that provide the framework for establishing quality assurance in an organization are:

Accepted Answer

A)   current good manufacturing practices.
B)   standard operating procedures.
C)   change control plan.
D)   continuous quality improvement plan.

Question 16

Which of the following organizations are involved in the regulation of blood banks?

Accepted Answer

A)   The Joint Commission
B)   AABB
C)   College of American Pathologists
D)   Food and Drug Administration

Question 17

The standard operating procedure is a document that:

Accepted Answer

A)   helps achieve consistency of results.
B)   may be substituted with package inserts.
C)   is necessary only for training new employees.
D)   must be very detailed to be accurate.

Question 18

Match the following descriptions with the appropriate terms.
-Proficiency test

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems

Question 19

Match the following descriptions with the appropriate terms.
-Preventive maintenance

Accepted Answer

A)  The CAP survey is an example
B)  Systematic evaluations to determine whether procedures are being followed
C)  Testing to determine the accuracy and precision of reagents and equipment
D)  Process of standardizing an instrument against a known value
E)  Removal of products from the market that might compromise the safety of the recipientF) Degree to which a measurement represents the true valueG) Establishing that a specific process produces an expected resultH) Evaluation of an employee's ability to perform a specific skillI) Investigation and identification of the factors that contributed to an errorJ) Maximizes the duration of equipment and increases the reliability of the equipmentK) System to plan and implement changes to prevent problems J

Question 20

All of the following are responsibilities of the quality assurance department of a blood bank except:

Accepted Answer

A)   performing internal audits.
B)   performing quality control.
C)   reviewing standard operating procedures.
D)   reviewing and approving training programs. B

Exam 15: Quality Assurance and Regulation of the Blood Industry

Quality control is the same as quality assurance.

Correct AnswerverifiedShow Answer

A facility does not validate a refrigerator before use. What is a potential outcome?

Correct AnswerverifiedA

Match the following descriptions with the appropriate terms. -Accuracy

Correct AnswerverifiedShow Answer

Match the following descriptions with the appropriate terms. -Quality control

Correct AnswerverifiedShow Answer

Match the following descriptions with the appropriate terms. -Audit

Correct AnswerverifiedShow Answer

Which of the following is an example of an unacceptable record-keeping procedure?

Correct AnswerverifiedShow Answer

Several units were released to a hospital by mistake before all viral marker testing was completed. What is the appropriate course of action?

Correct AnswerverifiedShow Answer

Which of the following is true regarding good manufacturing practices (GMPs) ?

Correct AnswerverifiedShow Answer

In a routine audit of a facilities blood collection area, the quality assurance department found that the blood bags being used on that particular day had expired. What is the appropriate course of action?

Correct AnswerverifiedShow Answer

All of the following are true regarding competency testing except:

Correct AnswerverifiedShow Answer

Match the following descriptions with the appropriate terms. -Competency assessment

Correct AnswerverifiedShow Answer

Unacceptable quality control results for the antiglobulin test performed in test tubes may be noticed if:

Correct AnswerverifiedShow Answer

A technologist was being trained in a different area of the blood bank and noticed that the person training her had not recorded the results of a test. To be helpful, she carefully recorded the results she saw at a later time, using the technologist's initials. Is this acceptable procedure?

Correct AnswerverifiedShow Answer

Match the following descriptions with the appropriate terms. -Root cause analysis

Correct AnswerverifiedShow Answer

Plans that provide the framework for establishing quality assurance in an organization are:

Correct AnswerverifiedShow Answer

Which of the following organizations are involved in the regulation of blood banks?

Correct AnswerverifiedShow Answer

The standard operating procedure is a document that:

Correct AnswerverifiedShow Answer

Match the following descriptions with the appropriate terms. -Proficiency test

Correct AnswerverifiedShow Answer

Match the following descriptions with the appropriate terms. -Preventive maintenance

Correct AnswerverifiedJ

All of the following are responsibilities of the quality assurance department of a blood bank except:

Correct AnswerverifiedB

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