Question 1

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

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)  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.
-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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems J

Question 4

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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems

Question 5

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. 
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 6

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. 
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 7

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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems

Question 8

Quality control is the same as quality assurance.

Accepted Answer

A)  True 
B)  False 
A)  True 
B)  False

Question 9

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. 
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 10

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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems

Question 11

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

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. 
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

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. 
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 14

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. 
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 15

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

Question 17

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 
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 18

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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems

Question 19

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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems

Question 20

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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems 
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 recipient
F)Degree to which a measurement represents the true value
G)Establishing that a specific process produces an expected result
H)Evaluation of an employee's ability to perform a specific skill
I)Investigation and identification of the factors that contributed to an error
J)Maximizes the duration of equipment and increases the reliability of the equipment
K)System to plan and implement changes to prevent problems

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

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

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

Match the following descriptions with the appropriate terms. -Accuracy

All of the following are true regarding competency testing except:

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?

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

Quality control is the same as quality assurance.

The standard operating procedure is a document that:

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

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

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

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?

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

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

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

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

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

Match the following descriptions with the appropriate terms. -Audit

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

Immunology: Basic Principles and Applications in the Blood Bank

Blood Banking Reagents: Overview and Applications in Immunohematology

Genetic Principles in Blood Banking

Abo and H Blood Group Systems and Secretor Status

Rh Blood Group System

Other Blood Group Systems

Antibody Detection and Identification

Compatibility Testing

Donor Selection and Phlebotomy

Testing of Donor Blood

Blood Component Preparation and Therapy

Adverse Complications of Transfusions

Hemolytic Disease of the Fetus and Newborn

Transfusion Therapy in Selected Patients

Safety Issues in the Blood Bank

Filters

Exam 15: Quality Assurance and Regulation of the Blood Industry

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

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

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

Match the following descriptions with the appropriate terms. -Accuracy

All of the following are true regarding competency testing except:

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?

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

Quality control is the same as quality assurance.

The standard operating procedure is a document that:

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

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

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

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?

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

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

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

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

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

Match the following descriptions with the appropriate terms. -Audit

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

Immunology: Basic Principles and Applications in the Blood Bank

Blood Banking Reagents: Overview and Applications in Immunohematology

Genetic Principles in Blood Banking

Abo and H Blood Group Systems and Secretor Status

Rh Blood Group System

Other Blood Group Systems

Antibody Detection and Identification

Compatibility Testing

Donor Selection and Phlebotomy

Testing of Donor Blood

Blood Component Preparation and Therapy

Adverse Complications of Transfusions

Hemolytic Disease of the Fetus and Newborn

Transfusion Therapy in Selected Patients

Safety Issues in the Blood Bank

Filters