Deck 16: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank

Question 1

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.

Answer 1

B
Quality control is performed in the laboratory,not by the quality assurance department.

Question 2

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.

Answer 2

A
Good manufacturing practices are requirements established by the Food and Drug Administration.

Question 3

Personal protective equipment includes:

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

Answer 3

D
Safety glasses,splash barriers,and masks are types of personal protective devices.

Question 4

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 5

In safety training,employees must become familiar with all of the following except:

A)tasks that have an infectious risk.
B)limits of protective clothing and equipment.
C)the appropriate action to take if exposure occurs.
D)how to perform cardiopulmonary resuscitation on a donor or other employee.

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?

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

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

Question 8

Biosafety levels determine:

A)on what floor certain infectious disease testing can be performed.
B)the degree of risk for certain areas of a health care facility to exposure to infectious diseases.
C)the amount of ventilation required in a transfusion service.
D)how many biohazardous waste containers a laboratory must have.

Question 9

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 10

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

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 11

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 12

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.

Question 13

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 14

A laboratory technologist decided she would like to bring her lab coat home for laundering because it had too many wrinkles when it was returned by the laboratory's laundry service.Is this acceptable?

A)Yes,if she uses 10% bleach
B)Yes,if she clears it with her supervisor
C)Yes,as long as she removes the coat and does not wear it home
D)No,because the laboratory is a biosafety level 2,and lab coats may not be removed

Question 15

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 16

Quality control is the same as quality assurance.

A)True
B)False

Question 17

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 18

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.

Question 19

Blood irradiators require all of the following safety procedures except:

A)proper training.
B)that the user have a degree in radiology.
C)equipment leak detection.
D)personal protective equipment.

Question 20

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

A)True
B)False

Question 21

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 incident.
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 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 government or accrediting agencies with the description that best fits their purpose.
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
AABB

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
Competency assessment

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
Validation

Question 26

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

Question 27

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 28

Match the government or accrediting agencies with the description that best fits their purpose.
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
FDA

Question 29

Match the government or accrediting agencies with the description that best fits their purpose.
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
CAP

Question 30

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 31

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 32

Match the government or accrediting agencies with the description that best fits their purpose.
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
CDC

Question 33

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 34

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 35

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 36

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 37

Match the government or accrediting agencies with the description that best fits their purpose.
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
OSHA

Question 38

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