Blood Banking/Transfusion Medicine Page 1 of 27. Revised 9/2014

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1 Blood Banking/Transfusion Medicine Page 1 of 27 Revised 9/2014 Blood Banking/Transfusion Medicine Major Category Code Headings I Clinical Practice II Cell and Tissue Therapy III RBCs and RBC Components IV Apheresis V Hazards of Transfusion: Specific Adverse Events VI Plasma Components and Derivatives VII Infectious Hazards of Transfusion VIII Blood Donors and Blood Collection IX Quality, Legal and Regulatory Issues in Transfusion Medicine and Transplantation X Surgery Patients XI Biovigilence & Transfusion-Related Immunomodulation XII Platelets XIII Neutrophils XIV Intravascular Cell Kinetics XV Obstetric and Pediatric Patients XVI Hematopoietic Progenitor Cell (HPC) Transplantation 14500

2 Blood Banking/Transfusion Medicine Page 2 of 27 Cat Code Blood Banking/Transfusion Medicine I Clinical Practice A Autoimmune Hemolytic Anemia Classification, Epidemiology, and Causes Warm autoimmune hemolytic anemia a Pathophysiology b Autoantibodies and Specificity c Clinical Features d Laboratory Features e Treatment Cold Hemagglutinin Disease a Pathophysiology b Autoantibodies and Specificity c Clinical Features d Laboratory Features e Treatment Paroxysmal Cold Hemoglobinuria a Pathophysiology b Autoantibodies and Specificity c Clinical Features d Laboratory Features e Treatment Drug-Induced Immune Hemolytic Anemia a Drug Adsorption Mechanism b Drug-Dependent Antibody Mechanism c Autoimmune Induction Mechanism B Paroxysmal Nocturnal Hemoglobinuria Clinical Picture and Course Causes and Pathogenesis Laboratory Features Treatment Transfusions C Anemia in Oncology Patients Causes Clinical Features Management a Growth Factors b Transfusion Therapy D Immune Thrombocytopenia General Tests to Investigate Thrombocytopenia Platelet Antibody Assays (non-hit) Tests for Heparin-Induced Thrombocytopenia Platelet genotyping Idiopathic (Immune) Thrombocytopenic Purpura a Pathogenesis 10176

3 Blood Banking/Transfusion Medicine Page 3 of 27 b Clinical Features c Laboratory Features d Treatment e Immune Thrombocytopenic Purpura in Pregnancy f Acute Immune Thrombocytopenic Purpura of Childhood g Chronic Immune Thrombocytopenic Purpura of Childhood h Secondary Immune Thrombocytopenic Purpura Drug-Induced Immune Thrombocytopenia a Heparin-Induced Thrombocytopenia i Pathogenesis ii Treatment and Management b Typical Drug-Induced Immune Thrombocytopenia c Atypical Drug-Induced Thrombocytopenic Purpura d Drug-Induced Thrombotic Thrombocytopenic Purpura and Hemolytic Uremic Syndrome Alloimmune Thrombocytopenia a Platelet Alloantigens, Immunogenetics and Frequency of Alloimmune Thrombocytopenia b Neonatal Alloimmune Thrombocytopenia i Pathophysiology and Clinical Features ii Neonatal Treatment iii Prenatal Management c Posttransfusion Purpura i Pathophysiology and Clinical Features ii Treatment d Passive Alloimmune Thrombocytopenia e Transplantation-Associated Alloimmune Thrombocytopenia i Hematopoietic Transplantation ii Solid organ Transplantation f Platelet Transfusion Refractoriness Causes, Mechanisms and Management E Bleeding From Acquired Coagulation Defects and Antithrombotic Therapy Liver Disease a Pathophysiology b Laboratory Features c Management of Bleeding Vitamin K Deficiency 10312

4 Blood Banking/Transfusion Medicine Page 4 of 27 a Role of Vitamin K in Hemostasis b Hemorrhagic Disease of the Newborn c Other Causes of Vitamin K Deficiency d Treatment Disseminated Intravascular Coagulation a Pathophysiology b Clinical Features c Laboratory Features d Treatment Coagulation Factor Inhibitors a Factor VIII Inhibitors b Lupus Anticoagulants c Acquired von Willebrand Syndrome d Factor V Inhibitors e Acquired Factor X Deficiency f Other Coagulation Inhibitors Acquired Platelet Function Disorders a Drug-Induced Platelet Dysfunction b Uremia c Cardiopulmonary Bypass Antithrombotic Therapy a Warfarin b Heparin c Low Molecular Weight Heparins d Factor Xa Inhibitors e Direct Thrombin Inhibitors f Fibrinolytic Agents F Granulocyte Transfusion (Primarily Donor Issues) Indications and Patient Selection Donor Selection and Criteria Donor Stimulation Corticosteroids and G-CSF Product Collection Product Storage and Transport Product Selection Special Needs Infusion and Monitoring Adverse Events (Donor and Recipient) Clinical Outcomes G Transfusion Risks and Reactions in Oncology Infectious Graft-Versus-Host Disease Alloantibodies Iron Overload II Cell and Tissue Therapy A HLA Antigens and Alleles Major Histocompatibility Complex Class I and II Antigens and Their Function Polymorphism of HLA System and Nomenclature 10516

5 Blood Banking/Transfusion Medicine Page 5 of 27 4 Identification of HLA Antigens, Antibodies and Alleles a Serologic Methods b Cellular Methods c Nucleic Acid-Based Methods d Crossmatching Genotypes, Phenotypes and Haplotypes Medical and Biological Significance of HLA a Transplantation i Hematopoietic Progenitor Cell ii Solid Organ b Disease Association B Tissue banking Human Allograft Applications Tissue Donation a Living Donors b Deceased Donors c Referral for Donation Organization of Tissue Banking in the United States Public Attitudes Regarding Organ and Tissue Donation Tissue Transplant-Transmissible Diseases Tissue Donor Suitability and Tissue Transplant Risk Reduction a Donor History Screening b Donor Physical Assessment c Tissue Recovery Methods d Infectious Disease Testing e Tissue Sterilization General Principles of Tissue Preservation and Clinical Use a Bone b Cartilage, Meniscus, Tendon, Ligament and Dura Mater c Skin d Ocular Tissue e Cardiovascular Tissue f Peripheral Nerve g Parathyroid h Reproductive Tissue i Semen ii Oocytes and Embryos ii Extraembryonic Transfusion Service Support of Tissue Transplantation Tissue Banking and Transplantation Oversight C Adoptive Immunotherapy Immunotherapy Targets for Cancer T-Cell Immunotherapy Targets for Infections Types of Adoptive Immunotherapy 10688

6 Blood Banking/Transfusion Medicine Page 6 of 27 a Non-specific T Cells b Antigen-Specific T Cell Therapies c Genetically-Modified T Cells Approaches to Improving Cellular Immunotherapy Adoptive Immunotherapy regulatory Issues D Gene Therapy in Transfusion Medicine Targeted Genes Vector Design Viral Vectors Adeno-Associated Virus Adenoviral vectors Non-Viral Gene Therapy Clinical Protocols and Trials E Tissue Engineering and Regenerative Medicine Overview Skin Blood Vessel Bone Cartilage Urology Cardiac Corneal III RBCs and RBC Components A Red Cell Production and Kinetics Erythropoietin a Regulation of Production b Interaction with and Effects on Erythroid Progenitor Cells Nutritional Requirements for Erythropoiesis Influence of Pathologic States on Erythropoiesis B Oxygen Delivery and Use of Red Cells and Red Cell Substitutes for Oxygen Delivery 1 Regulation of Systemic Oxygen Delivery Regulation of Regional Oxygen Delivery Regulation of Oxygen Delivery in the Microcirculation a Red Cell Transfusion and the Microcirculation b Effect of Red Cell Storage Changes on the Microcirculation (N Oxide) Oxygen carrying Red Cell Substitutes a Hemoglobin-Based b Perfluorocarbon-Based C Red Cell Metabolism and Preservation Metabolism a Glucose b Alternative Substrates c Regulation of Energy Metabolism d Synthetic Processes 10884

7 Blood Banking/Transfusion Medicine Page 7 of 27 e Membrane Metabolism Red Cell Preservation in Transfusion Medicine a General Principles b Collection and Separation Procedures c Anticoagulant-Nutrient Solutions d Additive Solutions e Additional Factors Influencing RBC Quality f Functionality g Rejuvenation h Frozen Storage i Validation of RBC Storage Systems D Red Cell Immunology and Compatibility Testing Red Cell Immunology a Immune Response Components and Characteristics b Blood Group Antibodies - Physical Properties and Characteristics c Red Cell Antigen-Antibody Interactions i Direct Agglutination ii Hemolysis iii Antiglobulin test Compatibility Testing a Donor Testing b Patient testing i Sample Collection ii ABO Typing iii Rh Typing iv Tests for Unexpected Antibodies v Reagents Red Cells for Antibody Detection vi Automated Pretransfusion testing vii Additional Techniques viii Molecular Techniques c Principles of Antibody Identification d Donor-Recipient Testing i Prior Records Check ii Selection of Blood for Transfusion iii Serologic Crossmatch iv Electronic Crossmatch v Labeling vi Issue vii Emergency Release viii Bedside Check ix Hemovigilance E Carbohydrate Blood Groups and Blood Group Systems ABH Antigens 11052

8 Blood Banking/Transfusion Medicine Page 8 of 27 a Biochemistry b Antigenic variants c Secretion d Se and H genes e H-Deficient Phenotypes and Genotypes f Medical Implications of the ABH and Secretor Systems i ABO-Incompatible Solid Organ Transplantation ii ABO-Incompatible Hematopoietic Progenitor Cell Transplantation Lewis System Ii System P System F Rh and LW Blood Group Systems Rh Blood Group System - General Information and Nomenclature Rh Genes and Their Expressed Proteins Molecular Basis for Rh Antigen Expression a D Antigen b C/c and E/e Antigens c RH Genotyping Rh-membrane Complex Rh Function Immune Response to Rh a Medical Aspects b Serologic Aspects c Molecular Aspects LW Blood Group System a General information b Genes and Their Expressed Proteins c Molecular Basis for Antigen Expression d LW Function G Other Protein Blood Group Systems Kell and Kx Blood a Structure, Function, and Interaction of the Kell and XK Proteins b Kell - Transfusion Medicine Aspects i Transfusions ii Hemolytic Disease of the Fetus and Newborn c Kell Variants Duffy a Structure and Function of the Duffy Protein b Duffy - Transfusion Medicine Aspects i Transfusions 11212

9 Blood Banking/Transfusion Medicine Page 9 of 27 ii Hemolytic Disease of the Fetus and Newborn Kidd a Structure and Function of the Kidd Protein b Kidd - Transfusion Medicine Aspects i Transfusions ii Hemolytic Disease of the Fetus and Newborn MNS a Structure and Function of Glycophorins A and B b MNS - Transfusion Medicine Aspects Diego Gerbich Colton and GIL Lutheran Indian, Xg, and Scianna Chido/Rodgers Knops Cartwright, Dombrock, Cromer and JMH OK and RAPH H Anemia and Red Blood Cell Transfusion Physiologic Adaptations to Blood Loss and Anemia a Oxygen Transport Principles and Mechanisms b Adaptive Mechanisms in Anemia c Microcirculatory Effects of Anemia and Red Cell Transfusion d Pathophysiologic Processes and Anemia Interactions Clinical Outcomes of Anemia and Red Cell Transfusion a Risks of Anemia b Efficacy of Transfusion i Adults ii Children Transfusion Guidelines Red Cell Transfusions - Decision Making a Bleeding Patient b Surgical Patient c Chronic Anemia d Transfusion Threshold e Dose and Administration IV Apheresis A Apheresis: Principles and Technology of Hemapheresis General Information and Principles Current Devices and Technology Donor Apheresis a Donor Care 11420

10 Blood Banking/Transfusion Medicine Page 10 of 27 b Specific Products and Procedures c Adverse Effects on Donors and Recipients Therapeutic Apheresis a Procedural and Technical Aspects i Substances Removed ii Volume Removed iii Replacement Fluids (Technical and Composition Details) iv Schedule of Procedures (Timing, Number, Location) v Equipment vi Vascular access vii Anticoagulant viii Oversight ix Adverse Effects B Therapeutic Plasma Exchange General Principles a Mathematic Principles b Regulation of IgG Metabolism c Replacement Fluids (Clinical Aspects) d Selective Extraction of Plasma Components e Indication and Treatment Intensity Categories Neurologic Disorders a Guillain-Barré Syndrome b Chronic Inflammatory Demyelinating Polyneuropathy c Peripheral neuropathy and Monoclonal Gammopathy d Myasthenia Gravis e Lambert-Eaton Myasthenic Syndrome f Neuromyotonia and Limbic Encephalitis g Stiff-Person Syndrome h Paraneoplastic Neurologic Syndromes i Nonneoplastic Disorders with Central nervous System Antibodies j Multiple Sclerosis Hematologic and Oncologic Disorders a Monoclonal Proteins b Blood Cell Alloantibodies c Thrombotic Thrombocytopenic Purpura d Hemolytic Uremic Syndrome e Posttransfusion Purpura f Idiopathic (Immune) Thrombocytopenic Purpura g Autoimmune Hemolytic Anemia h Pure Red Cell Aplasia and Aplastic Anemia 11580

11 Blood Banking/Transfusion Medicine Page 11 of 27 i Coagulation Factor Inhibitors Rheumatic and Other Immunologic Disorders a Cryoglobulinemia b Rheumatoid Arthritis c Systemic Lupus Erythematosus d Systemic Vasculitis Polymyositis and Dermatomyositis e Goodpasture Syndrome f Rapidly Progressive Glomerulonephritis Other g Solid Organ Transplantation i Rejection ii Disease Recurrence Toxic and Metabolic Disorders a Hypercholesterolemia b Refsum s Disease c Drug Overdose and Poisoning d Acute Liver Failure C Specialized Therapeutic Hemapheresis and Phlebotomy Red Cell Exchange a Principles and Techniques b Sickle Cell Disease c Acute and/or Emergent Complications Indications and Management d Chronic Conditions or Preventive Strategies Indications and Management e Malaria f Babesiosis Erythrocytapheresis and Therapeutic Phlebotomy a Polycythemia Vera b Secondary Erythrocytosis c Hereditary Hemochromatosis Therapeutic Platelet Apheresis a Primary Thrombocytosis b Secondary Thrombocytosis Therapeutic White Cell Apheresis a Hyperleukocytosis b Inflammatory Bowel Disease Extracorporeal Photochemotherapy a Techniques and Mechanisms b Cutaneous T-Cell Lymphoma c Cardiac Allograft Rejection d Graft-Versus-Host Disease Selective Extraction of Low-Density Lipoproteins a Principles, Indications, and Techniques V Hazards of Transfusion: Specific Adverse Events A Hemolytic Transfusion Reactions 11804

12 Blood Banking/Transfusion Medicine Page 12 of 27 1 Incidence Signs and Symptoms Complications Causes Differential Diagnosis Laboratory Investigation Pathophysiology Treatment Prevention B Febrile, Allergic, and Nonimmune Transfusion Reactions Febrile Nonhemolytic a Description and Characteristics b Causes c Diagnosis d Treatment e Prevention Allergic a Description and Characteristics b Causes c Diagnosis d Treatment e Prevention Anaphylactic and Anaphylactoid a Description and Characteristics b Causes c Diagnosis d Treatment e Prevention Massive and Rapid Transfusion - Complications a Definitions and Description b Citrate Toxicity c Electrolyte and Acid/Base Disorders d Hypothermia e Microaggregate Reactions Circulatory Overload a Description and Characteristics b Causes c Diagnosis d Treatment e Prevention Toxic Reactions Resulting From Blood Manufacture or Processing a Hypotensive b Ocular c Plasticizer Toxicity 11980

13 Blood Banking/Transfusion Medicine Page 13 of 27 d Dimethyl Sulfoxide Toxicity and Cryopreserved Progenitor Cells Special Transfusion Settings a Granulocyte Transfusion b Autologous Transfusion C Transfusion-Associated Graft-Versus-Host Disease Pathophysiology Incidence Risk Factors - General Fetuses and Neonates Patient Populations At Risk a Congenital Immunodeficiency Syndromes b Malignancies c Hematopoietic Progenitor Cell Transplants d Solid Organ Transplants Immunocompetent Patients Risk Factors Clinical Presentation and Diagnosis Treatment Prevention D Transfusion-Induced Iron Overload Pathophysiology Iron Burden of Transfusions Clinical Features Measurement of Iron Burden Management a Goals b Chelation Therapy E Transfusion-Related Acute Lung Injury Incidence and Epidemiology Clinical Features Pathophysiology a Acute Lung Injury - Features b Causes c Mechanisms of Lung Damage d Multiple Hit/Threshold Theory Diagnosis and Differential Diagnosis a Clinical, Physiologic, Radiologic, and Laboratory Features b Consensus Definition Treatment and Management Donor Investigation Prevention F Posttransfusion Purpura Pathophysiology and Clinical Features Treatment G Transfusion-Associated Dyspnea 12180

14 Blood Banking/Transfusion Medicine Page 14 of 27 VI Plasma Components and Derivatives A Plasma Composition General Features and Factors Influencing Plasma Composition Albumin Immunoglobulins Alpha-1-Antitrypsin C1 Inhibitor Von Willebrand Factor Cleaving Protease Coagulation Factors, Coagulation Factor Inhibitors, and von Willebrand Factor B Preparation of Plasma Derivatives Plasma Procurement Plasma Manufacture Pathogen Inactivation/Removal Plasma Products Indications and Clinical Use Adverse Effects Industry Safety Programs Recombinant DNA Technology and Manufacturing C Plasma Transfusion and Use of Albumin and Rh Immune Globulin Fresh Frozen, Frozen, Cryo-Poor, Thawed, and Stored Plasma a Manufacture and Features b Clinical Use, Indications and Guidelines for Use i Surgery ii Massive Transfusion, Trauma, and Disseminated Intravascular iii Intensive care iv Liver Disease v Warfarin Reversal vi Therapeutic Apheresis c Dosing d Risks and Adverse Effects e Pathogen-Inactivated Plasma Cryoprecipitate a Manufacture and Features b Clinical Use, Indications and Guidelines for Use c Risks and Adverse Effects Albumin a Manufacture and Features b Clinical Use, Indications and Guidelines for Use c Risks and Adverse Effects Rh Immune Globulin 12350

15 Blood Banking/Transfusion Medicine Page 15 of 27 a Manufacture and Features b Clinical Use, Indications and Guidelines for Use c Risks and Adverse Effects VII Infectious Hazards of Transfusion A Transfusion-Transmitted Hepatitis Incidence Hepatitis B Virus a Epidemiology b Transmission c Clinical Features i Acute Infection ii Chronic Infection d Serologic and Molecular Markers of Infection e Donor Testing and Counseling f Prevention g Treatment Hepatitis C Virus a Epidemiology b Transmission c Clinical Features i Acute Infection ii Chronic Infection d Donor Testing and Counseling e Prevention f Treatment Hepatitis A Virus a Epidemiology b Transmission c Clinical Features d Donor Testing and Counseling e Prevention f Treatment Hepatitis D Virus a Epidemiology b Diagnosis c Transmission d Clinical Features e Prevention Non-A, Non-B, Non-C Hepatitis B Retroviruses Overview Human Immunodeficiency Virus a General Information and Epidemiology b Incidence and Prevalence Among Blood Donors 12560

16 Blood Banking/Transfusion Medicine Page 16 of 27 c Window Period and Risk of Transmission d Donor Testing and Counseling e Clinical Features f Prevention g Treatment Human T-Cell Lymphotropic Viruses a General Information and Epidemiology b Incidence and Prevalence Among Blood Donors c Window Period and Risk of Transmission d Donor Testing and Counseling e Clinical Features f Prevention g Treatment C Cytomegalovirus General Information and Epidemiology Incidence and Prevalence Among Blood Donors Window Period and Risk of Transmission Donor Testing and Counseling Clinical Features Prevention Treatment Other herpesviruses D Other Viruses Parvovirus B a General Information and Epidemiology b Transmission c Clinical Features West Nile Virus a General Information and Epidemiology b Transmission c Donor Testing and Counseling d Clinical Features e Prevention E Transfusion Transmission of Parasites Chagas Disease a General Information and Epidemiology b Transmission c Donor Testing and Counseling d Clinical Features e Prevention Malaria a General Information and Epidemiology b Transmission c Donor Testing and Counseling d Clinical Features e Prevention 12740

17 Blood Banking/Transfusion Medicine Page 17 of 27 3 Babesiosis a General Information and Epidemiology b Transmission c Donor Testing and Counseling d Clinical Features e Prevention Leishmaniasis a General Information and Epidemiology b Transmission c Donor Testing and Counseling d Clinical Features e Prevention F Bacterial Contamination of Blood Products Red Blood Cells Overview and Epidemiology Allogeneic RBCs Agents and Incidence Autologous RBCs Agents and Incidence Plasma, Cryoprecipitate and Derivatives - Agents and Incidence Platelets a Source of Contamination b Agents and Incidence c Clinical Features d Treatment e Prevention Strategies to Reduce the Risk of Posttransfusion Sepsis a Donor Screening b Skin Preparation c Diversion d Apheresis Versus Whole Blood-Derived Platelets e Storage Time and Temperature f Bacterial Detection g Bacterial Elimination Syphilis Lyme Disease G Prion Diseases General Information and Epidemiology Transmission Clinical Features Risk Management Donor Selection Blood Component Processing Plasma Derivative manufacture Cellular, Tissue, and Organ Transplantation H Pathogen Inactivation Overview and description 12912

18 Blood Banking/Transfusion Medicine Page 18 of 27 2 Plasma a Solvent/Detergent Treatment b Methylene Blue Light Treatment c Psoralen Ultraviolet Light Treatment d Riboflavin Light Treatment Platelet a Psoralen Ultraviolet Light Treatment b Riboflavin Light Treatment c Thionine Light Treatment Red Cell a Alkylating Agents b Photosensitizers c Riboflavin Light Treatment Emerging Technologies VIII Blood Donors and Blood Collection A Recruitment and Screening of Donors and the Collection, Processing and testing of Blood Organization of Blood Services a United States b Outside United States Blood Donor Recruitment Collection Process a Donor Evaluation i Consent ii History and Physical Examination iii Laboratory Testing iv Deferral Criteria b Blood Collection i Whole Blood ii Component Separation iii Leukocyte Reduction iv Automated Collection c Blood Component Testing i ABO/Rh ii Antibody Screening iii Infectious Disease d Distribution e Source Plasma Blood Donor Adverse Events a Donor Reactions i Categories ii Incidence iii Clinical Features iv Risk Factors v Treatment vi Prevention b Phlebotomy-Related 13124

19 Blood Banking/Transfusion Medicine Page 19 of 27 i Categories ii Incidence iii Clinical Features iv Risk Factors v Treatment vi Prevention c Long-Term Effects of Donation i Iron ii Platelets iii Plasma Proteins IX Quality, Legal and Regulatory Issues in Transfusion Medicine and Transplantation A Current Legal Issues Blood Transfusion Injury Claims a Blood Shield Laws b Negligence c Standard of Care d Causation e Informed Consent Donor Injury Cord Blood Tissue Banking HIPAA Privacy Rule B Current Good Manufacturing Practice General Overview Licensing Products and Establishments Recalls and FDA Enforcement Activities Safety Initiatives Enforcement Options Rationale a Standard Operating Procedures b Record Keeping c Personnel and Training d Calibration e Validation f Labeling g Error Management h Quality Control Unit and Internal Audits i Facilities and Equipment j Process and Production Controls Information Management Common Violations C Transplant Organizations and Networks in the Regulation of Cellular and Tissue Therapy Programs Hematopoietic Progenitor Cells a Sources b Indications 13336

20 Blood Banking/Transfusion Medicine Page 20 of 27 c HLA Matching d Donor Registries and Networks e Outcomes Registries, Professional Associations and Networks f Accrediting Organizations Other Cellular Therapies a Organizational Aspects b Accreditation and Regulation Tissue Banks a Organizational Aspects b Accreditation and Regulation D Hospital Transfusion Services, Transfusion Committee and Quality Assurance 1 Role of the Medical Director a Administrative b Clinical c Education Quality Assurance a Process Control b Error Management c Improving Transfusion Practice Regulatory and Accreditation Requirements a Food and Drug Administration b AABB c Joint Commission d College of American Pathologists Transfusion Committee a Membership b Functions c Oversight of Transfusion Policies, Procedures, and Guidelines d Education E Other Administrative Issues X Surgery Patients A Alternatives to Transfusion: Perioperative Blood Management Preoperative a Autologous Blood Donation b Anemia optimization i Iron ii Erythropoietin Intraoperative/Postoperative a Acute Normovolemic hemodilution b Intraoperative autologous blood recovery and reinfusion (cell salvage) c Postoperative autologous blood recovery and reinfusion B Hemostasis for Surgery/Invasive Procedures 13544

21 Blood Banking/Transfusion Medicine Page 21 of 27 1 Preprocedure Blood Components a Common Laboratory tests of Hemostasis and Their Relationship With Procedure-related b Procedure-Related Bleeding i Central Venous Catheter ii Liver Biopsy iii Thoracentesis and Paracentesis iv Gastrointestinal Endoscopy and Biopsy v Procedures on Upper Airway, Bronchoscopy, and Transbronchial vi Renal Biopsy vii Epidural Anesthesia, Lumbar Puncture, and Neurosurgical Procedures viii Angiography Treatment of Bleeding a Local i Physical Sutures, Electrocautery, Compression, Direct Packing, etc ii Topical Agents iii Topical Sealants iv Topical Thrombin v Topical Antifibrinolytics b Generalized i Skin and Membrane ii Purpura and Soft Tissue iii Small Vessel Bleeding During Surgery C Transfusion Therapy for Trauma and Burn Patients Shock a General Information and Definition b Hemorrhagic Shock and Classification i Acidosis ii Hypothermia iii Coagulopathy c Trauma Patient i Initial Resuscitation aa Damage Control ab Blood Component Therapy ac Hemostatic Agents ad Pharmacologic Agents ii Intraoperative aa Damage Control ab Temperature ac Blood Component Therapy ad Autotransfusion ae Solid Organ Injury 13708

22 Blood Banking/Transfusion Medicine Page 22 of 27 af Hemostatic Agents ag Pharmacologic Agents iii Recovery Phase aa Blood Component Therapy iv Massive Transfusion aa Definition ab Blood Component Therapy ac Complications d Burn Patient i Initial Resuscitation aa Fluid Therapy Colloid Crystalloid ab Transfusion Therapy ac Hemostatic Agents ad Pharmacologic Agents D Transfusion Therapy in Solid Organ Transplantation Organ Procurement and Transplants Immunologic Barriers ABO and HLA a Management Across Immunologic Barriers b Organ Selection c Plasma Exchange d Pharmacologic Agents Immunohematology a Patient Alloantibodies b Passenger Lymphocyte Antibodies Transfusion Therapy a Liver b Heart c Lung d Kidney e Pancreas f Other Special Needs a CMV Low Risk b Leukocyte Reduction c Irradiation XI Biovigilence & Transfusion-Related Immunomodulation A Biovigilance/Hemovigilance Requirements for Effective Program Scope a What Should Be Reported i Adverse Reactions ii Adverse Incidents iii Near Misses b Biovigilance 13932

23 Blood Banking/Transfusion Medicine Page 23 of 27 i Passive Reporting Versus Active Surveillance ii Traceability c Blood Donors d Transfusion Recipients B Immunomodulatory and Proinflammatory Effects of Allogeneic Blood Transfusion Concepts and Overview Laboratory Features Beneficial Clinical Effects a Enhanced Survival of Renal Allografts b Reduced Risk of Recurrent Spontaneous Abortions c Reduced Risk of recurrence of Crohn s Disease Deleterious Clinical Effects a Increased Recurrence of Resected Malignancies b Increased Risk of Postoperative Bacterial Infection c Increased Risk of Short-Term Mortality XII Platelets A Platelet Production (Thrombopoiesis) Megakaryocyte Development, Maturation, and Differentiation Thrombopoietic/Megakaryocyte/Hematopoietic Growth Factors Genetic and Cellular Regulation of Thrombopoiesis Platelet Production/Shedding/Release B Platelet immunology Platelet Antigens (ABO, HLA, Platelet Specific) Disorders of Platelet Alloimmunization Platelet Autoimmunity C Platelets in the Bloodstream Platelet Circulation/Distribution/Destruction Platelet Survival/Kinetics in Health and Disease D Platelets and Hemostasis Normal Platelet Plug and Clot Formation Genetic/Congenital Platelet Disorders Acquired Platelet Disorders E Platelet Transfusions Collection and Storage of Platelet Preparations/Concentrates Clinical Platelet Transfusions (Indications, Dose and Schedule) Alternatives to Platelet Transfusions (Thrombopoietic and Pharmacologic agents)

24 Blood Banking/Transfusion Medicine Page 24 of 27 XIII Neutrophils A Neutrophil Production (Myelopoiesis) Neutrophil Development, Maturation and Differentiation Myelopoietic/Hematopoietic Growth Factors Genetic and Cellular Regulation of Myelopoiesis Neutrophil Release, Compartments and Circulating Kinetics B Neutrophil Immunology Neutrophil Antigens (ABO, HLA, Neutrophil Specific) Disorders of Neutrophil Alloimmunization and Autoimmunity C Neutrophils and Infections Neutrophil Response to Infections Neutrophil Antimicrobial Functions Neutrophil Congenital and Acquired disorders D Neutrophil/Granulocyte Transfusions (Primarily Clinical Issues) Neutrophil Collection, Storage and Transfusion Alternatives to Neutrophil Transfusions (Myelopoietic Factors) XIV Intravascular Cell Kinetics A Concepts of Post-Transfusion Recovery and Tracking Labeled/Tracer cells B Techniques of Radiolabeling Blood Cells (RBCs, Platelets and Leukocytes) C Use of Non-Radioactive Cellular Labels D Methods/Calculations for Determining Intravascular Cell Kinetics E Cell Kinetic Applications in Health and Disease XV Obstetric and Pediatric Patients A Obstetric Transfusion Practices Maternal Hematologic Disorders During Pregnancy Maternal Hemorrhage and Transfusions During Pregnancy Fetal (Intrauterine) Transfusions B Hemolytic Disease of the Fetus and Newborn ABO Incompatibility Rh(D) and Other Fetal-Maternal RBC Incompatibilities Fetal RBC Membrane/Metabolic or Hemoglobin Abnormalities Management a Diagnostic and Surveillance Tests b Fetal and Neonatal Transfusions, Phototherapy, IVIG, etc) C Congenital Disorders of Clotting and Anticoagulant Proteins Developmental Physiology of Plasma Proteins Hemophilia A, B and von Willebrand Disease (Pathophysiology and Treatment) 14356

25 Blood Banking/Transfusion Medicine Page 25 of 27 3 Congenital Disorders of Non-Hemophilia Clotting Proteins Congenital Disorders of Anticoagulant/Prothrombotic Proteins D Congenital Hemoglobinopathies and Hemolytic Anemias Sickle Cell Disease (Pathophysiology and Treatment) Non-Sickle Cell Hemoglobinopathies Thalassemias (Pathophysiology and Treatment) Congenital Red Cell Membrane and Enzyme Defects E Neonatal Transfusions Anemia of Prematurity (Pathophysiology and Treatment) Thrombocytopenia of Prematurity (Pathophysiology and Treatment) Neonatal Blood Banking Practices (Dedicated Units, WBC-Reduction, Irradiation, etc) Neonatal/Infant Plasma, Cryoprecipitate and Neutrophil Transfusions F Congenital Disorders of Hematopoiesis XVI Hematopoietic Progenitor Cell (HPC) Transplantation A Biology of Marrow Transplantation Indications, Methods, Results, Adverse Effects 1 Autologous Allogeneic / Syngeneic B Biology of HPC and HPC Transplantation HPC Biology Identification and Measurement of HPC Allogeneic/Syngeneic Donor Selection, Qualification, Eligibility HLA Typing for HPC Transplantation Processing Requirements for HPC a General b Patient-Specific Regulatory, Compliance, Accreditation C HPC Sources and Collection HPC - Marrow a Methods of Harvesting b Characteristics, c Adverse Effects HPC Apheresis Characteristics and Adverse effects a Biology of Stem Cell Mobilization b Mobilization Regimens (Indications, Dose, Schedule, Efficacy, Adverse Effects) i Chemotherapy ii Growth Factors G-CSF, GM-CSF iii Adhesion blockers Plerixafor 14592

26 Blood Banking/Transfusion Medicine Page 26 of 27 c Scheduling Mobilization and Apheresis Collection d Monitoring Mobilization and HPC Collection e Collection of Lymphocytes for Infusion (Donor Lymphocyte Infusion; DLI) f Apheresis Considerations Techniques, Vascular Access, Donor Management, and HPC - Cord Blood - Characteristics, and Methods a Cord Blood Banking - Donor Eligibility, Collection Methods, Processing, Testing, Cryopreservation b Cord Blood Unit Characteristics c Donor Selection for Transplant (Unrelated and Related) Selection of the Appropriate HPC Source for a Given Patient D HPC Processing - Goals, Guidelines, and Methods (preparation for infusion) 1 HPC for Autologous Transplants HPC for Allogeneic Transplant Indications for Plasma, RBC Reduction, Preparation of Cells for Donor Lymphocyte Infusion (DLI) Cord Blood Processing of Other CT Products (eg Antigen-Directed T cells, Marrow Stromal Cells) E HPC Storage and Preservation Liquid Storage and Transport - Anticoagulant, Time, Temperature, Preservative, Cell Concentration Rationale for Cryopreservation Cryopreservation Theory and Practice a Cryoprotectants b Cryopreservaton Techniques Controlled Rate, "Dump Freeze" c Storage - Mechanical and Liquid Nitrogen F Management of RBC Antigen Incompatibility in Allogeneic Transplantation - ABO/Rh, HLA, Other Graft Management - Depletion of RBC (Major), Plasma (Minor) Patient Transfusion Management a Major or Minor ABO Incompatibility Immediate vs Delayed Hemolysis b Passenger Lymphocyte Syndrome (PLS), Cause, Diagnosis, Course, Therapy, Prevention Ablative vs Non-Ablative (Immunosuppressive) Conditioning Pediatric Considerations for Graft Manipulation 14708

27 Blood Banking/Transfusion Medicine Page 27 of 27 G HPC Assessment - Pre- and Post-Processing and Post-Thaw Cell Counts and Methods HPC Measurement and Enumeration a Flow Cytometry CD34+ Cells and Other Markers (Single vs Dual platform) b Non-Flow Methods HPC Viability Assessment Techniques HPC Cell Culture Assays HPC Functional and Differentiation Assays HPC Microbial Assessment - Gram Stain, Cultures - Aerobic, Anaerobic, Fungal H Cell Selection Methods and Applications Positive and Negative Selection - Techniques, Results, Indications CD34 Cells and Others (eg Treg) Tumor Purging and T Cell Depletion I HPC and CTP Thawing and Post-Thaw Processing (Apheresis, Marrow, Cord Blood, etc) Direct HPC Infusion vs Pre-Infusion Cell Washing Special Considerations for Preparation of Cord Blood HPC for infusion J HPC and CTP infusion General Guidelines Filters, No Irradiation, Infusion Rate, DMSO Limits, Infusion Pumps Adverse Effects and Infusion Reactions Incidence, Causes, Diagnosis, Management Management and Infusion of Contaminated Products K Engraftment Definition, Chimerism, Relationship to CD34+ Cell Doses Rates - Autologous vs Allogeneic, Related vs MUD, HPC Source, Conditioning Engraftment failure Causes, Management Immune Reconstitution Post-Transplant Donor Lymphocyte Infusion Rationale, Efficacy L HPC Lab quality assurance and accreditation - AABB, FACT, CAP, NMDP 1 Regulatory Considerations Federal GMP, GTP; State M Laboratory Administration - Staff Hiring and Training, Facilities, Equipment, Supplies, Laboratory Development, Deviations, Non N Experimental Cell Therapies Institutional vs Commercially Sponsored Types (eg Marrow Stromal, Adoptive Therapy with T Cells, Gene-Modified Cells) Special Requirements for Processing (Clean Room, etc) Regulatory Considerations 14844

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