AABB Standards Review Exam
Questions & Answers 2023/2024
When are AABB standards updated? - ANSWER-Every 2 years
True or False: The AABB Standards are mandatory for Blood Banks or Transfusion Services to follow? -
ANSWER-False; only if you are seeking AABB accreditation
What does it mean when a standard has the following words: *Shall/Must* - ANSWER-The standard is
mandatory and failure to comply results in nonconformance
What does it mean when a standard has the following words: *Should/May* - ANSWER-The standard is
recommended and is not required for accreditation
What does it mean when a standard has the following statement: *By a method known to* - ANSWER-
Previously published data overrides separate QC
What does the pen symbol next to a standard indicate? - ANSWER-Indicates the need for a documented
record to be in compliance
How many Quality Systems Essential are there in the AABB Standards? - ANSWER-10
What are the 10 QSEs? - ANSWER-1. Organization
2. Resources
3. Equipment
4. Supplier and Customer Issues
5. Process Control
6. Documents and Records
7. Deviations, Nonconformances, Adverse Events
,8. Assessments
9. Process Improvement
10. Facilities and Safety
What is the timeline when the 31st edition of the Standards are in effect? - ANSWER-01 April 2018 - 01
April 2020
Who has ultimate responsibility in the Blood Bank? - ANSWER-The Medical Director
Can Medical Director duties be delegated? - ANSWER-Yes
Who does the Quality Representative/QA report to? - ANSWER-Executive Management
Who are our customers? - ANSWER-1. Staff members
2. Physicians/Nurses
3. Patients
What two types of emergency preparedness/ Disaster preparedness plans must a blood bank have? -
ANSWER-1. External
2. Internal
Whose contact information must be readily available for employees as a way to communicate concerns
about quality or safety? - ANSWER-AABB's contact information
What is four areas are involved with Human Resources? - ANSWER-1. Qualifications
2. Training
3. Competence
4. Personnel Records
What are the 6 areas of competency that must be assessed? - ANSWER-1. Direct observation of testing
, 2. Monitoring the recording/reporting of results
3. Review of test results or QC/maint records
4. Direct observation of instrument maintenance
5. Assessment of test performance through previously analyzed specimens
6. Assessment of problem solving skills
What are the 3 steps of equipment qualification (validation)? - ANSWER-1. Installation
2. Operational
3. Performance
True or False: Each piece of equipment must have a unique identification. - ANSWER-True
When is equipment calibration performed? - ANSWER-1. Before use
2. After activities that may affect calibration such as relocation
3. At prescribed intervals
How often must blood banks/donor centers monitor temperature? - ANSWER-Every 4 hours
When should monitoring devices alarm? - ANSWER-Before the upper and lower limits are reached so to
allow enough time for action to be taken before contents reach unacceptable conditions
True or False: Blood warmers have a temperature requirement - ANSWER-False; blood warmers need a
temperature sensing device and a warning system to prevent hemolysis
What series of the CFR are information systems located? - ANSWER-800 series (medical devices)
True or False: Blood bank information systems are considered medical devices and must be validated like
any other piece of equipment - ANSWER-True
Questions & Answers 2023/2024
When are AABB standards updated? - ANSWER-Every 2 years
True or False: The AABB Standards are mandatory for Blood Banks or Transfusion Services to follow? -
ANSWER-False; only if you are seeking AABB accreditation
What does it mean when a standard has the following words: *Shall/Must* - ANSWER-The standard is
mandatory and failure to comply results in nonconformance
What does it mean when a standard has the following words: *Should/May* - ANSWER-The standard is
recommended and is not required for accreditation
What does it mean when a standard has the following statement: *By a method known to* - ANSWER-
Previously published data overrides separate QC
What does the pen symbol next to a standard indicate? - ANSWER-Indicates the need for a documented
record to be in compliance
How many Quality Systems Essential are there in the AABB Standards? - ANSWER-10
What are the 10 QSEs? - ANSWER-1. Organization
2. Resources
3. Equipment
4. Supplier and Customer Issues
5. Process Control
6. Documents and Records
7. Deviations, Nonconformances, Adverse Events
,8. Assessments
9. Process Improvement
10. Facilities and Safety
What is the timeline when the 31st edition of the Standards are in effect? - ANSWER-01 April 2018 - 01
April 2020
Who has ultimate responsibility in the Blood Bank? - ANSWER-The Medical Director
Can Medical Director duties be delegated? - ANSWER-Yes
Who does the Quality Representative/QA report to? - ANSWER-Executive Management
Who are our customers? - ANSWER-1. Staff members
2. Physicians/Nurses
3. Patients
What two types of emergency preparedness/ Disaster preparedness plans must a blood bank have? -
ANSWER-1. External
2. Internal
Whose contact information must be readily available for employees as a way to communicate concerns
about quality or safety? - ANSWER-AABB's contact information
What is four areas are involved with Human Resources? - ANSWER-1. Qualifications
2. Training
3. Competence
4. Personnel Records
What are the 6 areas of competency that must be assessed? - ANSWER-1. Direct observation of testing
, 2. Monitoring the recording/reporting of results
3. Review of test results or QC/maint records
4. Direct observation of instrument maintenance
5. Assessment of test performance through previously analyzed specimens
6. Assessment of problem solving skills
What are the 3 steps of equipment qualification (validation)? - ANSWER-1. Installation
2. Operational
3. Performance
True or False: Each piece of equipment must have a unique identification. - ANSWER-True
When is equipment calibration performed? - ANSWER-1. Before use
2. After activities that may affect calibration such as relocation
3. At prescribed intervals
How often must blood banks/donor centers monitor temperature? - ANSWER-Every 4 hours
When should monitoring devices alarm? - ANSWER-Before the upper and lower limits are reached so to
allow enough time for action to be taken before contents reach unacceptable conditions
True or False: Blood warmers have a temperature requirement - ANSWER-False; blood warmers need a
temperature sensing device and a warning system to prevent hemolysis
What series of the CFR are information systems located? - ANSWER-800 series (medical devices)
True or False: Blood bank information systems are considered medical devices and must be validated like
any other piece of equipment - ANSWER-True
