QUESTIONS AND CORRECT ANSWERS
When are AABB standards updated? - CORRECT ANSWERS Every 2
years
True or False: The AABB Standards are mandatory for Blood Banks or
Transfusion Services to follow? - CORRECT ANSWERS False; only if
you are seeking AABB accreditation
What does it mean when a standard has the following words: *Shall/Must* -
CORRECT ANSWERS The standard is mandatory and failure to comply
results in nonconformance
What does it mean when a standard has the following words: *Should/May* -
CORRECT ANSWERS 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* - CORRECT ANSWERS Previously published data overrides
separate QC
What does the pen symbol next to a standard indicate? - CORRECT ANSWERS
Indicates the need for a documented record to be in compliance
How many Quality Systems Essential are there in the AABB Standards? -
CORRECT ANSWERS 10
What are the 10 QSEs? - CORRECT ANSWERS 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? -
CORRECT ANSWERS 01 April 2018 - 01 April 2020
Who has ultimate responsibility in the Blood Bank? - CORRECT ANSWERS
The Medical Director
Can Medical Director duties be delegated? - CORRECT ANSWERS Yes
Who does the Quality Representative/QA report to? - CORRECT ANSWERS
Executive Management
Who are our customers? - CORRECT ANSWERS 1. Staff members
2. Physicians/Nurses
3. Patients
What two types of emergency preparedness/ Disaster preparedness plans must a
blood bank have? - CORRECT ANSWERS 1. External
2. Internal
, Whose contact information must be readily available for employees as a way to
communicate concerns about quality or safety? - CORRECT ANSWERS
AABB's contact information
What is four areas are involved with Human Resources? - CORRECT
ANSWERS 1. Qualifications
2. Training
3. Competence
4. Personnel Records
What are the 6 areas of competency that must be assessed? - CORRECT
ANSWERS 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)? - CORRECT
ANSWERS 1. Installation
2. Operational
3. Performance
True or False: Each piece of equipment must have a unique identification. -
CORRECT ANSWERS True
When is equipment calibration performed? - CORRECT ANSWERS 1.
Before use
2. After activities that may affect calibration such as relocation