SBB Program Exam Questions with Correct Answers (1)

SBB Program Exam Questions with Correct Answers (1) List the 12 AABB Quality System Components. - 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. - 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. - 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 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. - Answer-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. - Answer-Gray List the types and know the functions of Personal Protective Equipment used in a Blood Bank Laboratory. - Answer-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 - Answer- 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. - Answer-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. Define "Hemovigilance". - Answer-Hemovigilance is a set of surveillance procedures of the whole transfusion chain intended to minimize adverse events or reactions in donors and recipients and to promote safe and effective use of blood components. Make your own definition. Will have to define on the test. Trying to prevent- mainly adverse reactions. Know the minimal levels of hemoglobin and hematocrit for accepting Allogeneic and Autologous blood donors. - Answer-Acceptable hemoglobin and hematocrit concentration: Male- hemoglobin 13.0 g/dL or the essentially equivalent hematocrit of 39%. Female- hemoglobin 12.5 g/dL or the essentially equivalent hematocrit of 38% Female (waiver)- 12 g/dL or the essentially equivalent hematocrit of 36% Autologous units- hemoglobin of 11 g/dL or hematocrit of 33% Know the acceptable blood donation values for temperature, pulse, and blood pressure. - Answer-Temperature- ≤99.5°F (≤37.5°C) Pulse- between 50 and 100 beats per minute without irregularities in rhythm. Below 50- ask if they have high athletic ability? Blood Pressure- no higher than 180/100, no lower than 90/50. 90 to 180 systolic, and 50 to 100 diastolic. Blood Pressure and pulse not required by anybody- used to evaluate the health of the donor, if you use these parameters- have to have a range that is acceptable. Know the maximum amount of whole blood that can be collected from a donor. - Answer-10.5 mL/kg (magic number for tests) of donor's weight for each donation. Minimum weight (1kg=2.2 lbs) 110lbs (50kg) 10.5x50= 525 mL Calculate the amount of blood to collect from an underweight donor. Also, calculate the amount of anticoagulant to remove from the collection bag, if needed. - Answer- Example 1: Use 450 ml bag Patient weight 90 lbs Ratio: 90 lbs/110 lbs x 450 ml= 368 ml Example 2: Use 450 ml bag Patient weighs 70 lbs Ratio: 70 lbs/110 lbs x 450 ml= 286 ml (anticoagulant/blood ratio is off) Anticoagulant calculation: (all standard numbers) 286 ml/100 x 14 (.14 ml anticoagulant for each ml of whole blood)= 40 ml amount of anticoagulant that needs to be in the bag. 63 ml- 40 ml= 23 ml of anticoagulant removed from the bag. Limits: 450 bag= normal collection= 405-495 ml above 495- not enough anticoagulant- clots, below 405- low volume collection: 450- low volume: 300-404 ml (as long as the bag is above 300- you do not have to change the anticoagulant. 450 bag- 63 ml of anticoagulant Know the contents of the CPDA-1 anticoagulant and preservative and the function of each. - Answer-Citrate- anticoagulant- kelates calcium Phosphate- buffer- maintains the pH (7.2/7.3) more acidic after sitting in the bag- after build up of hydrogen- pH goes down. Binds up hydrogen ions. Dextrose- ATP production Adenine- Source of adenosine triphosphate (ATP) provides energy to drive many processes in living cells. More ATP production List the label requirements for all blood and blood component units. - Answer-Expiration date Unique identification number (unit number/lot number- batch (chemical that goes in to make a lot of product. Each donor is their own lot) Unique facility identifier Product ABO and Rh Storage temperature Referral to circular of information (users manual for the blood product, in every shipment of blood and available or handed out to donors) Autologous Biohazard Properly identified for intended recipient List the components that can be collected by apheresis technique. - Answer- Granulocytes Platelets cRBC- concurrent 1 unit of Red Blood Cells (most always collect two units of RBCs) Plasma (original)/cPlasma- concurrent plasma Stem cells