SBB program questions with correct answers

List the 12 AABB Quality System Components. Correct Answer-1. Organization and Leadership, 2. Customer Focus, 3. Human Resources, 4. Equipment Management, 5. Suppliers and materials management, 6. Process control and management, 7. documents and records, 8. information management, 9. management of nonconforming events, 10. monitoring and evaluation, 11. process improvement, and 12. facilities, work environment, and safety. Define the documentation hierarchy, representing the levels of documents in an organization. Correct Answer-Level 1- Policies-tell us what to do or who does what. (Eg. organizational chart). Level 2- Processes- tell you how to do something (how it happens). eg. Flow chart Level 3- Procedures- how to do it (SOPs). Level 4- Supporting documents- proof it was done (eg. QC documents) ****Form not written on is a document, form written on is a record. Define the four Biosafety levels as published by OSHA and HHS. Correct Answer-Biosafety level 1 (BSL-1): involves work with agents of no known or minimal potential agents of no known or of minimal potential hazard to laboratory personnel and the environment. Activities are usually conducted on open surfaces, and no containment equipment is needed. No testing, admin areas. Biosafety Level 2 (BSL-2): work involves agents of moderate potential hazard to personnel and the environment, usually from contact associated exposure. Most blood bank laboratory activities are considers BSL-2. Biosafety Level 3 (BSL-3): includes work with indigenous or exotic agents that may cause serious or potentially lethal disease as a result of exposure to aerosols (eg. Mycobacterium tuberculosis) or by other routes (eg. HIV) that would result in grave consequences to the infected host. Negative pressure hood, anti-room to get into gear first, N-95 mask, lab coat, gloves. Biosafety Level 4 (BSL-4)- applies to work with dangerous or exotic agents that pose high individual risk of life-threatening dis