Deck 15: Quality Assurance and Regulation of the Blood Industry

Question 1

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

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.

Answer 1

D
Training, equipment maintenance, and reagent quality can affect quality control.

Question 2

The standard operating procedure is a document that:

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.

Answer 2

A
Standard operating procedures are written procedures that help achieve consistency and should be clear and concise.

Question 3

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?

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.

Answer 3

B
This is an example of poor record keeping; results must be recorded when the test is performed and by the person doing the test.

Question 4

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

Question 5

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

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

Question 6

Match the following descriptions with the appropriate terms.
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
Recall

Question 7

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

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

Question 8

Match the following descriptions with the appropriate terms.
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
Calibration

Question 9

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

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 10

Match the following descriptions with the appropriate terms.
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
Accuracy

Question 11

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

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 12

Match the following descriptions with the appropriate terms.
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
Validation

Question 13

Employee training takes place:

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 14

Match the following descriptions with the appropriate terms.
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
Quality control

Question 15

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?

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 16

Quality control is the same as quality assurance.

A) True
B) False

Question 17

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

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 18

All of the following are true regarding competency testing except:

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 19

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

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 20

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

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

Question 21

Match the following descriptions with the appropriate terms.
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
Competency assessment

Question 22

Match the following descriptions with the appropriate terms.
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
Preventive maintenance

Question 23

Match the following descriptions with the appropriate terms.
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
Proficiency test

Question 24

Match the following descriptions with the appropriate terms.
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
Audit

Question 25

Match the following descriptions with the appropriate terms.
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
Change control