AABB Standards Review | 100% Correct Answers | Verified | Latest 2024 Version

When are AABB standards updated? - Every 2 years True or False: The AABB Standards are mandatory for Blood Banks or Transfusion Services to follow? - False; only if you are seeking AABB accreditation What does it mean when a standard has the following words: *Shall/Must* - The standard is mandatory and failure to comply results in nonconformance What does it mean when a standard has the following words: *Should/May* - 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* - Previously published data overrides separate QC What does the pen symbol next to a standard indicate? - Indicates the need for a documented record to be in compliance How many Quality Systems Essential are there in the AABB Standards? - 10 What are the 10 QSEs? - 1. Organization 2. Resources 3. Equipment 4. Supplier and Customer Issues 5. Process Control 6. Documents and Records 7. Deviations, Nonconformances, Adverse Events 8. Assessments9. Process Improvement 10. Facilities and Safety What is the timeline when the 31st edition of the Standards are in effect? - 01 April 2018 - 01 April 2020 Who has ultimate responsibility in the Blood Bank? - The Medical Director Can Medical Director duties be delegated? - Yes Who does the Quality Representative/QA report to? - Executive Management Who are our customers? - 1. Staff members 2. Physicians/Nurses 3. Patients What two types of emergency preparedness/ Disaster preparedness plans must a blood bank have? - 1. External 2. Internal Whose contact information must be readily available for employees as a way to communicate concerns about quality or safety? - AABB's contact information What is four areas are involved with Human Resources? - 1. Qualifications 2. Training 3. Competence 4. Personnel Records What are the 6 areas of competency that must be assessed? - 1. Direct observation of testing2. 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)? - 1. Installation 2. Operational 3. Performance True or False: Each piece of equipment must have a unique identification. - True When is equipment calibration performed? - 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? - Every 4 hours When should monitoring devices alarm? - Before the upper and lower limits are reached so to allow enough time for action to be taken before contents reach unacceptable