SBB program questions with correct answers
List the 12 AABB Quality System Components. - verified answers; 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. - verified
answers; 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. - verified answers; 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 disease from aerosols (eg, agents of hemorrhagic fevers or filoviruses). BSL-4 is not
applicable to routine blood bank-related activities. Space suit- self contained safety suit.
Define and state the purpose of the SDS. - verified answers; Right to know- all you need to know
, SDS- Safety data sheet- identifies the physical and chemical properties of a hazardous chemical (eg, flash
point or vapor pressure), its physical and health hazards (eg, potential for fire, explosions, and signs and
symptoms of exposure), and precautions for the chemical's safe handling and use.
Know the common unit of measuring radiation doses. Irradiation- (graft vs host disease GVHD, near fatal
condition no cure). Sterilizing the lymphocytes. - verified answers; Gray
List the types and know the functions of Personal Protective Equipment used in a Blood Bank
Laboratory. - verified answers; Laboratory Coats- to protect your cloths from exposure
Gloves
Goggles
Face shield
Hand washing- nosocomial infection
Eyewashes to clean out eyes- tested once a week.
Chemicals in antibody identification lab
List the overall topics for the CFR Title 21 Sections of 200, 600, 800 and 1200 - verified answers; 200-
cGMP for drugs- blood is a drug because it is givn as a prescription to cure a disease
600- biological products- comes from a living thing
800- Medical devices
1200- Tissues- non blood products
Know how often the FDA inspects a blood establishment. - verified answers; The FDA inspects regulated
facilities to determine compliance with regulations. These inspections can classified as one of the
following:
Prelicense or preapproval inspection after a manufacturer submits an application to the FDA for a
biologics license or to market a new device or product.
Routine inspection of a regulated facility (generally every two years).
"For-cause" inspection, which involves investigation of a specific problem that has come to the FDA's
attention, such as a complaint or fatality.
List the 12 AABB Quality System Components. - verified answers; 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. - verified
answers; 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. - verified answers; 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 disease from aerosols (eg, agents of hemorrhagic fevers or filoviruses). BSL-4 is not
applicable to routine blood bank-related activities. Space suit- self contained safety suit.
Define and state the purpose of the SDS. - verified answers; Right to know- all you need to know
, SDS- Safety data sheet- identifies the physical and chemical properties of a hazardous chemical (eg, flash
point or vapor pressure), its physical and health hazards (eg, potential for fire, explosions, and signs and
symptoms of exposure), and precautions for the chemical's safe handling and use.
Know the common unit of measuring radiation doses. Irradiation- (graft vs host disease GVHD, near fatal
condition no cure). Sterilizing the lymphocytes. - verified answers; Gray
List the types and know the functions of Personal Protective Equipment used in a Blood Bank
Laboratory. - verified answers; Laboratory Coats- to protect your cloths from exposure
Gloves
Goggles
Face shield
Hand washing- nosocomial infection
Eyewashes to clean out eyes- tested once a week.
Chemicals in antibody identification lab
List the overall topics for the CFR Title 21 Sections of 200, 600, 800 and 1200 - verified answers; 200-
cGMP for drugs- blood is a drug because it is givn as a prescription to cure a disease
600- biological products- comes from a living thing
800- Medical devices
1200- Tissues- non blood products
Know how often the FDA inspects a blood establishment. - verified answers; The FDA inspects regulated
facilities to determine compliance with regulations. These inspections can classified as one of the
following:
Prelicense or preapproval inspection after a manufacturer submits an application to the FDA for a
biologics license or to market a new device or product.
Routine inspection of a regulated facility (generally every two years).
"For-cause" inspection, which involves investigation of a specific problem that has come to the FDA's
attention, such as a complaint or fatality.
