Exam (elaborations)

AABB Standards Review Exam Questions & Answers 2023/2024

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AABB Standards

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Uploaded on September 8, 2023
Number of pages 21
Written in 2023/2024
Type Exam (elaborations)
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aabb standards review exam questions answers 202

Institution AABB Standards
Course AABB Standards

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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

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Exam (elaborations)

AABB Standards Review Exam Questions & Answers 2023/2024

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