Question 1

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 2

Personal protective equipment includes:

Accepted Answer

A)  safety glasses. 
B)  splash barriers. 
C)  masks. 
D)  All of the above

Question 3

Employee training takes place:

Accepted Answer

A)  after hiring and following implementation of new procedures. 
B)  following competency assessment. 
C)  only for new inexperienced employees. 
D)  as procedures are validated.

Question 4

The Occupation Safety and Health Administration does not require the routine use of gloves by phlebotomists working with healthy prescreened donors or changing unsoiled gloves between donors.

Accepted Answer

A) True 
 B)False

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 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 6

Match the following descriptions with the appropriate terms.
-Change 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

Question 7

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 8

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.

Question 9

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 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

Question 11

Match the following descriptions with the appropriate terms.
-Validation

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

Question 12

All accidents,even minor ones,must be reported to a supervisor.

Accepted Answer

A) True 
 B)False

Question 13

MATCHING
Match the government or accrediting agencies with the description that best fits their purpose.
-AABB

Accepted Answer

A) Ensures safe and healthful working conditions 
B) Ensures the safety and efficacy of biologics, drugs, and devices 
C) Provides peer-reviewed accreditation for hospital laboratories 
D) Professional organization that accredits blood banks and transfusion services 
E) Makes recommendations to the Occupational Safety and Health Administration regarding the prevention of disease transmission

Question 14

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

Question 15

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 16

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

Question 17

At what point in the employment process should safety training take place?

Accepted Answer

A)  During orientation and training 
B)  Following lab training when employees are more familiar with their responsibilities 
C)  Following the employees' first evaluation 
D)  Before independent work is permitted and annually thereafter

Question 18

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.

Exam 1: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank

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

Personal protective equipment includes:

Employee training takes place:

The Occupation Safety and Health Administration does not require the routine use of gloves by phlebotomists working with healthy prescreened donors or changing unsoiled gloves between donors.

Match the following descriptions with the appropriate terms. -Audit

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

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

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

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

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

Match the following descriptions with the appropriate terms. -Validation

All accidents,even minor ones,must be reported to a supervisor.

MATCHING Match the government or accrediting agencies with the description that best fits their purpose. -AABB

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

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

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

At what point in the employment process should safety training take place?

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