Revised 8/2017 Blood Banking/Transfusion Medicine Major ...€¦ · 10 Surgery Patients 13500 11 Biovigilence & Transfusion-Related Immunomodulation 13900 ... 3 Cold Hemagglutinin

Blood Banking/Transfusion Medicine Page 1 of 26

Revised 8/2017

Blood Banking/Transfusion Medicine Major Category Code Headings

1 Clinical Practice 10004

2 Cell and Tissue Therapy 10500

3 RBCs and RBC Components 10800

4 Apheresis 11400

5 Hazards of Transfusion: Specific Adverse Events 11800

6 Plasma Components and Derivatives 12200

7 Infectious Hazards of Transfusion 12400

8 Blood Donors and Blood Collection 13000

9 13200

10 Surgery Patients 13500

11 Biovigilence & Transfusion-Related Immunomodulation 13900

12 Platelets 14000

13 Neutrophils 14100

14 Intravascular Cell Kinetics 14200

15 Obstetric and Pediatric Patients 14300

16 Hematopoietic Progenitor Cell (HPC) Transplantation 14500

Quality, Legal and Regulatory Issues in Transfusion Medicine and Transplantation


Cat Code

Blood Banking/Transfusion Medicine 10000

1 Clinical Practice 10004

A Autoimmune Hemolytic Anemia 10008

1 Classification, Epidemiology, and Causes 10012

2 Warm autoimmune hemolytic anemia 10016

a Pathophysiology 10020

b Autoantibodies and Specificity 10024

c Clinical Features 10028

d Laboratory Features 10032

e Treatment 10036

3 Cold Hemagglutinin Disease 10040





e Treatment 10060

4 Paroxysmal Cold Hemoglobinuria 10064





e Treatment 10084

5 Drug-Induced Immune Hemolytic Anemia 10088

a Drug Adsorption Mechanism 10092

b Drug-Dependent Antibody Mechanism 10096

c Autoimmune Induction Mechanism 10100

B Paroxysmal Nocturnal Hemoglobinuria 10104

1 Clinical Picture and Course 10108

2 Causes and Pathogenesis 10112

3 Laboratory Features 10116

4 Treatment 10120

5 Transfusions 10124

C Anemia in Oncology Patients 10128

1 Causes 10132

2 Clinical Features 10136

3 Management 10140

a Growth Factors 10144

b Transfusion Therapy 10148

D Immune Thrombocytopenia 10152

1 General Tests to Investigate Thrombocytopenia 10156

2 Platelet Antibody Assays (non-HIT) 10160

3 Tests for Heparin-Induced Thrombocytopenia 10164

4 Platelet genotyping 10168

5 Idiopathic (Immune) Thrombocytopenic Purpura 10172

a Pathogenesis 10176

b Clinical Features 10180

c Laboratory Features 10184

d Treatment 10188


e 10192

f 10196

g 10200

h 10204

6 Drug-Induced Immune Thrombocytopenia 10208

a Heparin-Induced Thrombocytopenia 10212

i Pathogenesis 10216

ii Treatment and Management 10220

b 10224

c 10228

d 10232

7 Alloimmune Thrombocytopenia 10236

a 10240

b Neonatal Alloimmune Thrombocytopenia 10244

i 10248

ii Neonatal Treatment 10252

iii Prenatal Management 10256

c Posttransfusion Purpura 10260

i Pathophysiology and Clinical Features 10264

ii Treatment 10268

d Passive Alloimmune Thrombocytopenia 10272

e 10276

i Hematopoietic Transplantation 10280

ii Solid organ Transplantation 10284

f 10288

E 10292

1 Liver Disease 10296


b Laboratory Features 10304

c Management of Bleeding 10308

2 Vitamin K Deficiency 10312

a Role of Vitamin K in Hemostasis 10316

b Hemorrhagic Disease of the Newborn 10320

c Other Causes of Vitamin K Deficiency 10324

d Treatment 10328

3 Disseminated Intravascular Coagulation 10332


b Clinical Features 10340

Drug-Induced Thrombotic Thrombocytopenic Purpura and

Hemolytic Uremic Syndrome

Typical Drug-Induced Immune Thrombocytopenia

Atypical Drug-Induced Thrombocytopenic Purpura

Platelet Alloantigens , Immunogenetics and Frequency of

Alloimmune Thrombocytopenia

Pathophysiology and Clinical Features

Immune Thrombocytopenic Purpura in Pregnancy

Acute Immune Thrombocytopenic Purpura of Childhood

Chronic Immune Thrombocytopenic Purpura of Childhood

Secondary Immune Thrombocytopenic Purpura

Transplantation-Associated Alloimmune Thrombocytopenia

Platelet Transfusion Refractoriness – Causes, Mechanisms

and Management

Bleeding From Congenital and Acquired Coagulation Defects and

Antithrombotic Therapy


c Laboratory Features 10344

d Treatment 10348

4 Coagulation Factor Inhibitors 10352

a Factor VIII Inhibitors 10356

b Lupus Anticoagulants 10360

c Acquired von Willebrand Syndrome 10364

d Factor V Inhibitors 10368

e Acquired Factor X Deficiency 10372

f Other Coagulation Inhibitors 10376

5 Acquired Platelet Function Disorders 10380

a Drug-Induced Platelet Dysfunction 10384

b Uremia 10388

c Cardiopulmonary Bypass 10392

6 Antithrombotic Therapy 10396

a Warfarin 10400

b Heparin 10404

c Low Molecular Weight Heparins 10408

d Factor Xa Inhibitors 10412

e Direct Thrombin Inhibitors 10416

f Fibrinolytic Agents 10420

7 Congenital Coagulopathies/Thrombophilias 10421

a Von Willebrand Disease 10422

b Factor Deficiencies, At III, Protein C, Protein S Deficiencies 10423

F Granulocyte Transfusion (Primarily Donor Issues) 10424

1 Indications and Patient Selection 10428

2 Donor Selection and Criteria 10432

3 Donor Stimulation – Corticosteroids and G-CSF 10436

4 Product Collection 10440

5 Product Storage and Transport 10444

6 Product Selection – Special Needs 10448

7 Infusion and Monitoring 10452

8 Adverse Events (Donor and Recipient) 10456

9 Clinical Outcomes 10460

G Transfusion Risks and Reactions in Oncology 10464

1 Infectious 10468

2 Graft-Versus-Host Disease 10472

3 Alloantibodies 10476

4 Iron Overload 10480

2 Cell and Tissue Therapy 10500

A HLA Antigens and Alleles 10504

1 Major Histocompatibility Complex 10508

2 Class I and II Antigens and Their Function 10512

3 Polymorphism of HLA System and Nomenclature 10516

4 Identification of HLA Antigens, Antibodies and Alleles 10520

a Serologic Methods 10524

b Cellular Methods 10528

c Nucleic Acid-Based Methods 10532

d Crossmatching 10534

5 Genotypes, Phenotypes and Haplotypes 10536

6 Medical and Biological Significance of HLA 10540


a Transplantation 10544

i Hematopoietic Progenitor Cell 10548

ii Solid Organ 10552

b Disease Association 10556

B Tissue banking 10560

1 Human Allograft Applications 10564

2 Tissue Donation 10568

a Living Donors 10572

b Deceased Donors 10576

c Referral for Donation 10580

3 Organization of Tissue Banking in the United States 10584

4 Public Attitudes Regarding Organ and Tissue Donation 10588

5 Tissue Transplant-Transmissible Diseases 10592

6 10596

a Donor History Screening 10600

b Donor Physical Assessment 10604

c Tissue Recovery Methods 10608

d Infectious Disease Testing 10612

e Tissue Sterilization 10616

7 10620

a Bone 10624

b 10628

c Skin 10632

d Ocular Tissue 10636

e Cardiovascular Tissue 10640

f Peripheral Nerve 10644

g Parathyroid 10648

h Reproductive Tissue 10652

i Semen 10656

ii Oocytes and Embryos 10660

ii Extraembryonic 10664

8 Transfusion Service Support of Tissue Transplantation 10668

9 Tissue Banking and Transplantation Oversight 10672

C Adoptive Immunotherapy 10676

1 Immunotherapy Targets for Cancer 10680

2 T-Cell Immunotherapy Targets for Infections 10684

3 Types of Adoptive Immunotherapy 10688

a Non-specific T Cells 10692

b Antigen-Specific T Cell Therapies 10696

c Genetically-Modified T Cells 10700

4 Approaches to Improving Cellular Immunotherapy 10704

5 Adoptive Immunotherapy regulatory Issues 10708

D Gene Therapy in Transfusion Medicine 10712

1 Targeted Genes 10716

2 Vector Design 10720

3 Viral Vectors 10724

4 Adeno-Associated Virus 10728

Cartilage, Meniscus, Tendon, Ligament and Dura Mater

Tissue Donor Suitability and Tissue Transplant Risk Reduction

General Principles of Tissue Preservation and Clinical Use


5 Adenoviral vectors 10732

6 Non-Viral Gene Therapy 10736

7 Clinical Protocols and Trials 10740

E Tissue Engineering and Regenerative Medicine 10744

1 Overview 10748

2 Skin 10752

3 Blood Vessel 10756

4 Bone 10760

5 Cartilage 10764

6 Urology 10768

7 Cardiac 10772

8 Corneal 10776

3 RBCs and RBC Components 10800

A Red Cell Production and Kinetics 10804

1 Erythropoietin 10808

a Regulation of Production 10812

b 10816

2 Nutritional Requirements for Erythropoiesis 10820

3 Influence of Pathologic States on Erythropoiesis 10824

B 10828

1 Regulation of Systemic Oxygen Delivery 10832

2 Regulation of Regional Oxygen Delivery 10836

3 Regulation of Oxygen Delivery in the Microcirculation 10840

a Red Cell Transfusion and the Microcirculation 10844

b 10848

4 Oxygen carrying Red Cell Substitutes 10852

a Hemoglobin-Based 10856

b Perfluorocarbon-Based 10860

C Red Cell Metabolism and Preservation 10864

1 Metabolism 10868

a Glucose 10872

b Alternative Substrates 10876

c Regulation of Energy Metabolism 10880

d Synthetic Processes 10884

e Membrane Metabolism 10888

2 Red Cell Preservation in Transfusion Medicine 10892

a General Principles 10896

b Collection and Separation Procedures 10900

c Anticoagulant-Nutrient Solutions 10904

d Additive Solutions 10908

e Additional Factors Influencing RBC Quality 10912

f Functionality 10916

g Rejuvenation 10920

h Frozen Storage 10924

i Validation of RBC Storage Systems 10928

D Red Cell Immunology and Compatibility Testing 10932

1 Red Cell Immunology 10936

Interaction with and Effects on Erythroid Progenitor Cells

Oxygen Delivery and Use of Red Cells and Red Cell Substitutes for Oxygen

Delivery

Effect of Red Cell Storage Changes on the Microcirculation

(N Oxide)


a 10940

b 10944

c Red Cell Antigen-Antibody Interactions 10948

i Direct Agglutination 10952

ii Hemolysis 10956

iii Antiglobulin test (DAT) 10960

2 Compatibility Testing 10964

a Donor Testing 10968

b Patient testing 10972

i Sample Collection 10976

ii ABO Typing 10980

iii Rh Typing 10984

iv Tests for Unexpected Antibodies 10988

v 10992

vi Automated Pretransfusion testing 10996

vii Additional Techniques 11000

viii Molecular Techniques 11002

c Principles of Antibody Identification 11004

d Donor-Recipient Testing 11008

i Prior Records Check 11012

ii Selection of Blood for Transfusion 11016

iii Serologic Crossmatch 11020

iv Electronic Crossmatch 11024

v Labeling 11028

vi Issue 11032

vii Emergency Release 11036

viii Bedside Check 11040

ix Hemovigilance 11044

E Carbohydrate Blood Groups and Blood Group Systems 11048

1 ABH Antigens 11052

a Biochemistry 11056

b Antigenic variants 11060

c Secretion 11064

d Se and H genes 11068

e H-Deficient Phenotypes and Genotypes 11072

f 11076

i 11080

ii 11084

2 Lewis System 11088

3 Ii System 11092

4 P System 11096

F Rh and LW Blood Group Systems 11100

1 11104

Immune Response – Components and Characteristics

Blood Group Antibodies - Physical Properties and

Characteristics

Reagents Red Cells for Antibody Detection

Medical Implications of the ABH and Secretor Systems

ABO-Incompatible Solid Organ Transplantation

ABO-Incompatible Hematopoietic Progenitor Cell

Transplantation

Rh Blood Group System - General Information and Nomenclature


2 Rh Genes and Their Expressed Proteins 11108

3 Molecular Basis for Rh Antigen Expression 11112

a D Antigen 11116

b C/c and E/e Antigens 11120

c RH Genotyping 11124

4 Rh-membrane Complex 11128

5 Rh Function 11132

6 Immune Response to Rh 11136

a Medical Aspects 11140

b Serologic Aspects 11144

c Molecular Aspects 11148

7 LW Blood Group System 11152

a General information 11156

b Genes and Their Expressed Proteins 11160

c Molecular Basis for Antigen Expression 11164

d LW Function 11168

G Other Protein Blood Group Systems 11172

1 Kell and Kx Blood 11176

a 11180

b Kell - Transfusion Medicine Aspects 11184

i Transfusions 11188

ii 11192

c Kell Variants 11196

2 Duffy 11200

a Structure and Function of the Duffy Protein 11204

b Duffy - Transfusion Medicine Aspects 11208


ii 11216

3 Kidd 11220

a Structure and Function of the Kidd Protein 11224

b Kidd - Transfusion Medicine Aspects 11228


ii 11236

4 MNS 11240

a 11244

b MNS - Transfusion Medicine Aspects 11248

5 Diego 11252

6 Gerbich 11256

7 Colton and GIL 11260

8 Lutheran 11264

9 Indian, Xg, and Scianna 11268

10 Chido/Rodgers 11272

11 Knops 11276

12 Cartwright, Dombrock, Cromer and JMH 11280

13 OK and RAPH 11284

Hemolytic Disease of the Fetus and Newborn



Structure and Function of Glycophorins A and B

Structure, Function, and Interaction of the Kell and XK

Proteins


H Anemia and Red Blood Cell Transfusion 11288

1 Physiologic Adaptations to Blood Loss and Anemia 11292

a Oxygen Transport Principles and Mechanisms 11296

b Adaptive Mechanisms in Anemia 11300

c 11304

d 11308

2 Clinical Outcomes of Anemia and Red Cell Transfusion 11312

a Risks of Anemia 11316

b Efficacy of Transfusion 11320

i Adults 11324

ii Children 11328

3 Transfusion Guidelines 11332

4 Red Cell Transfusions - Decision Making 11336

a Bleeding Patient 11340

b Surgical Patient 11344

c Chronic Anemia 11348

d Transfusion Threshold 11352

e Dose and Administration 11356

4 Apheresis 11400

A Apheresis: Principles and Technology of Hemapheresis 11404

1 General Information and Principles 11408

2 Current Devices and Technology 11412

3 Donor Apheresis 11416

a Donor Care 11420

b Specific Products and Procedures 11424

c Adverse Effects on Donors and Recipients 11428

4 Therapeutic Apheresis 11432

a Procedural and Technical Aspects 11436

i Substances Removed 11440

ii Volume Removed 11444

iii 11448

iv 11452

v Equipment 11456

vi Vascular access 11460

vii Anticoagulant 11464

viii Oversight 11468

ix Adverse Effects 11472

B Therapeutic Plasma Exchange 11476

1 General Principles 11480

a Mathematic Principles 11484

b Regulation of IgG Metabolism 11488

c Replacement Fluids (Clinical Aspects) 11492

d Selective Extraction of Plasma Components 11496

e Indication and Treatment Intensity Categories 11500

2 Neurologic Disorders 11504

a Guillain-Barré Syndrome 11508

Microcirculatory Effects of Anemia and Red Cell Transfusion

Pathophysiologic Processes and Anemia – Interactions

Replacement Fluids (Technical and Composition

Details)

Schedule of Procedures (Timing, Number,

Location)


b 11512

c 11516

d Myasthenia Gravis 11520

e Lambert-Eaton Myasthenic Syndrome 11524

f Neuromyotonia and Limbic Encephalitis 11528

g Stiff-Person Syndrome 11532

h Paraneoplastic Neurologic Syndromes 11536

i 11540

j Multiple Sclerosis 11544

3 Hematologic and Oncologic Disorders 11548

a Monoclonal Proteins 11552

b Blood Cell Alloantibodies 11556

c Thrombotic Thrombocytopenic Purpura 11560

d Hemolytic Uremic Syndrome 11564

e Posttransfusion Purpura 11568

f 11572

g Autoimmune Hemolytic Anemia 11576

h Pure Red Cell Aplasia and Aplastic Anemia 11580

i Coagulation Factor Inhibitors 11584

4 Rheumatic and Other Immunologic Disorders 11588

a Cryoglobulinemia 11592

b Rheumatoid Arthritis 11596

c Systemic Lupus Erythematosus 11600

d 11604

e Goodpasture Syndrome 11608

f 11612

g Solid Organ Transplantation 11616

i Rejection 11620

ii Disease Recurrence 11624

5 Toxic and Metabolic Disorders 11628

a Hypercholesterolemia 11632

b Refsum’s Disease 11636

c Drug Overdose and Poisoning 11640

d Acute Liver Failure 11644

C Specialized Therapeutic Hemapheresis and Phlebotomy 11648

1 Red Cell Exchange 11652

a Principles and Techniques 11656

b Sickle Cell Disease 11660

c 11664

d 11668

e Malaria 11672

2 Erythrocytapheresis and Therapeutic Phlebotomy 11680

Systemic Vasculitis Polymyositis and Dermatomyositis

Rapidly Progressive Glomerulonephritis – Other

Acute and/or Emergent Complications – Indications and

Management

Chronic Conditions or Preventive Strategies – Indications

and Management

Chronic Inflammatory Demyelinating Polyneuropathy

Peripheral neuropathy and Monoclonal Gammopathy

Nonneoplastic Disorders with Central nervous System

Antibodies

Idiopathic (Immune) Thrombocytopenic Purpura


a Polycythemia Vera 11684

b Secondary Erythrocytosis 11688

c Hereditary Hemochromatosis 11692

3 Therapeutic Platelet Apheresis 11696

a Primary Thrombocytosis 11700

b Secondary Thrombocytosis 11704

4 Therapeutic White Cell Apheresis 11708

a Hyperleukocytosis 11712

b Inflammatory Bowel Disease 11716

5 Extracorporeal Photochemotherapy 11720

a Techniques and Mechanisms 11724

b Cutaneous T-Cell Lymphoma 11728

c Cardiac Allograft Rejection 11732

d Graft-Versus-Host Disease 11736

6 Selective Extraction of Low-Density Lipoproteins 11740

a Principles, Indications, and Techniques 11744

5 Hazards of Transfusion: Specific Adverse Events 11800

A Hemolytic Transfusion Reactions 11804

1 Incidence 11808

2 Signs and Symptoms 11812

3 Complications 11816

4 Causes 11820

5 Differential Diagnosis 11824

6 Laboratory Investigation 11828

7 Pathophysiology 11832

8 Treatment 11836

9 Prevention 11840

B Febrile, Allergic, and Nonimmune Transfusion Reactions 11844

1 Febrile Nonhemolytic 11848

a Description and Characteristics 11852

b Causes 11856

c Diagnosis 11860

d Treatment 11864

e Prevention 11868

2 Allergic 11872


b Causes 11880

c Diagnosis 11884

d Treatment 11888

e Prevention 11892

3 Anaphylactic and Anaphylactoid 11896


b Causes 11904

c Diagnosis 11908

d Treatment 11912

e Prevention 11916

4 Massive and Rapid Transfusion - Complications 11920

a Definitions and Description 11924

b Citrate Toxicity 11928

c Electrolyte and Acid/Base Disorders 11932


d Hypothermia 11936

e Microaggregate Reactions 11940

5 Circulatory Overload 11944


b Causes 11952

c Diagnosis 11956

d Treatment 11960

e Prevention 11964

6 11968

a Hypotensive 11972

b Ocular 11976

c Plasticizer Toxicity 11980

d 11984

7 Special Transfusion Settings 11988

a Granulocyte Transfusion 11992

b Autologous Transfusion 11996

C Transfusion-Associated Graft-Versus-Host Disease 12000


2 Incidence 12008

3 Risk Factors - General 12012

4 Fetuses and Neonates 12016

5 Patient Populations At Risk 12020

a Congenital Immunodeficiency Syndromes 12024

b Malignancies 12028

c Hematopoietic Progenitor Cell Transplants 12032

d Solid Organ Transplants 12036

6 Immunocompetent Patients – Risk Factors 12040

7 Clinical Presentation and Diagnosis 12044

8 Treatment 12048

9 Prevention 12052

D Transfusion-Induced Iron Overload 12056


2 Iron Burden of Transfusions 12064


4 Measurement of Iron Burden 12072

5 Management 12076

a Goals 12080

b Chelation Therapy 12084

E Transfusion-Related Acute Lung Injury 12088

1 Incidence and Epidemiology 12092



a Acute Lung Injury - Features 12104

b Causes 12108

c Mechanisms of Lung Damage 12112

d Multiple Hit/Threshold Theory 12116

4 Diagnosis and Differential Diagnosis 12120

Toxic Reactions Resulting From Blood Manufacture or Processing

Dimethyl Sulfoxide Toxicity and Cryopreserved Progenitor

Cells


a 12124

b Consensus Definition 12128

5 Treatment and Management 12132

6 Donor Investigation 12136

7 Prevention 12140

F Posttransfusion Purpura 12160

1 Pathophysiology and Clinical Features 12164

2 Treatment 12168

G Transfusion-Associated Dyspnea 12180

6 Plasma Components and Derivatives 12200

A Plasma Composition 12204

1 12208

2 Von Willebrand Factor Cleaving Protease 12228

3 12232

B Preparation of Plasma Derivatives 12236

1 Plasma Procurement 12240

2 Plasma Manufacture 12244

3 Pathogen Inactivation/Removal 12248

4 Plasma Products – Indications and Clinical Use 12252

a. Prothrombin Complex Concentrate (PCC) 12253

5 Adverse Effects 12256

6 Industry Safety Programs 12260

7 Recombinant DNA Technology and Manufacturing 12264

a. Recombinant Factor Viia 12265

C 12268

1 12272

a Manufacture and Features 12276

b 12280

i Surgery 12284

ii 12288

iii Intensive care 12292

iv Liver Disease 12296

v Warfarin Reversal 12300

vi Therapeutic Apheresis 12304

c Dosing 12308

d Risks and Adverse Effects 12312

e Pathogen-Inactivated Plasma 12316

2 Cryoprecipitate 12320


b 12328

c Risks and Adverse Effects 12332

3 Albumin 12336


Massive Transfusion, Trauma, and Disseminated

Intravascular Coagulation

Clinical Use, Indications and Guidelines for Use

Clinical, Physiologic, Radiologic, and Laboratory Features

General Features and Factors Influencing Plasma Composition

Coagulation Factors, Coagulation Factor Inhibitors, and von

Willebrand Factor e.g. description, half-life

Plasma Transfusion and Use of Albumin and Rh Immune Globulin

Fresh Frozen, Frozen, Cryo-Poor, Thawed, and Stored Plasma



b 12344


4 Rh Immune Globulin 12350


b 12358


5 IVIG 12370

6 12380

a Alpha-1-Antitrypsin 12385

b C1 Inhibitor 12390

7 Infectious Hazards of Transfusion 12400

A Transfusion-Transmitted Hepatitis 12404

1 Incidence 12408

2 Hepatitis B Virus 12412

a Epidemiology 12416

b Transmission 12420


i Acute Infection 12428

ii Chronic Infection 12432

d Serologic and Molecular Markers of Infection 12436

e Donor Testing and Counseling 12440

f Prevention 12444

g Treatment 12448

3 Hepatitis C Virus 12452




i Acute Infection 12468

ii Chronic Infection 12472

d Donor Testing and Counseling 12476

e Prevention 12480

f Treatment 12484

4 Hepatitis A Virus 12488





e Prevention 12508

f Treatment 12512

5 Hepatitis D and Hepatitis E Virus 12516


b Diagnosis 12524

c Transmission 12528

d Clinical Features 12532

e Prevention 12536

6 Non-A, Non-B, Non-C Hepatitis 12540

B Retroviruses 12544



Other Plasma Derivatives, e.g. CMV, IG, HBV,IG, ISG, Rabies IG


1 Overview 12548

2 Human Immunodeficiency Virus 12552

a General Information and Epidemiology 12556

b 12560

c Window Period and Risk of Transmission 12564


e Clinical Features 12572

f Prevention 12576

g Treatment 12580

3 Human T-Cell Lymphotropic Viruses (HTLV) 12584


b 12592

c Window Period and Risk of Transmission 12596


e Clinical Features 12604

f Prevention 12608

g Treatment 12612

C Cytomegalovirus (CMV) 12616

1 General Information and Epidemiology 12620

2 Incidence and Prevalence Among Blood Donors 12624

3 Window Period and Risk of Transmission 12628

4 Donor Testing and Counseling 12632


6 Prevention 12640

7 Treatment 12644

8 Other herpesviruses 12646

D Other Viruses 12648

1 Parvovirus B19 12652




2 West Nile Virus 12668



c Donor Testing and Counseling 12680


e Prevention 12688

f Zika, Dengue and Chikungunya 12690

E Transfusion Transmission of Parasites 12692

1 Chagas’ Disease 12696





e Prevention 12716

2 Malaria 12720



Incidence and Prevalence Among Blood Donors

Incidence and Prevalence Among Blood Donors




e Prevention 12740

3 Babesiosis 12744





e Prevention 12764

f Treatment 12766

4 Leishmaniasis 12768





e Prevention 12788

F Bacterial Contamination of Blood Products 12792

1 Red Blood Cells – Overview and Epidemiology 12796

2 Allogeneic RBCs – Agents and Incidence 12800

3 Autologous RBCs – Agents and Incidence 12804

4 12808

5 Platelets 12812

a Source of Contamination 12816

b Agents and Incidence 12820


d Treatment 12828

e Prevention 12832

6 12836

a Donor Screening 12840

b Skin Preparation 12844

c Diversion 12848

d 12852

e Storage Time and Temperature 12856

f Bacterial Detection 12860

g Bacterial Elimination 12864

7 Syphilis 12868

8 Lyme Disease 12872

G Prion Diseases 12876

1 General Information and Epidemiology 12880

2 Transmission 12884


4 Risk Management – Donor Selection 12892

5 Blood Component Processing 12896

6 Plasma Derivative manufacture 12900

7 Cellular, Tissue, and Organ Transplantation 12904

H Pathogen Inactivation 12908

1 Overview and description 12912

Plasma, Cryoprecipitate and Derivatives - Agents and Incidence

Strategies to Reduce the Risk of Posttransfusion Sepsis

Apheresis Versus Whole Blood-Derived Platelets


2 Plasma 12916

a Solvent/Detergent Treatment 12920

b Methylene Blue Light Treatment 12924

c Psoralen Ultraviolet Light Treatment 12928

d Riboflavin Light Treatment 12932

3 Platelet 12936

a Psoralen Ultraviolet Light Treatment 12940

b Riboflavin Light Treatment 12944

c Thionine Light Treatment 12948

4 Red Cell 12952

a Alkylating Agents 12956

b Photosensitizers 12960

c Riboflavin Light Treatment 12964

5 Emerging Technologies 12968

8 Blood Donors and Blood Collection 13000

A 13004

1 Organization of Blood Services 13008

a United States 13012

b Outside United States 13016

2 Blood Donor Recruitment 13020

3 Collection Process 13024

a Donor Evaluation 13028

i Consent 13032

ii History and Physical Examination 13036

iii Laboratory Testing 13040

iv Deferral Criteria 13044

b Blood Collection 13048

i Whole Blood 13052

ii Component Separation 13056

iii Leukocyte Reduction 13060

iv Automated Collection 13064

c Blood Component Testing 13068

i ABO/Rh 13072

ii Antibody Screening 13076

iii Infectious Disease 13080

d Distribution 13084

e Source Plasma 13088

4 Blood Donor Adverse Events 13092

a Donor Reactions 13096

i Categories 13100

ii Incidence 13104

iii Clinical Features 13108

iv Risk Factors 13112

v Treatment 13116

vi Prevention 13120

b Phlebotomy-Related 13124

i Categories 13128

ii Incidence 13132

iii Clinical Features 13136

Recruitment and Screening of Donors and the Collection, Processing and

testing of Blood


iv Risk Factors 13140

v Treatment 13144

vi Prevention 13148

c Long-Term Effects of Donation 13152

i Iron 13156

ii Platelets 13160

iii Plasma Proteins 13164

9 13200

A Current Legal Issues 13204

1 Blood Transfusion Injury Claims 13208

a Blood Shield Laws 13212

b Negligence 13216

c Standard of Care 13220

d Causation 13224

e Informed Consent 13228

2 Donor Injury 13232

3 Cord Blood 13236

4 Tissue Banking 13240

5 HIPAA Privacy Rule 13244

B Current Good Manufacturing Practice 13248

1 General Overview 13252

2 Licensing Products and Establishments 13256

3 Recalls and FDA Enforcement Activities 13260

4 Safety Initiatives 13264

5 Enforcement Options 13268

6 Rationale 13272

a Standard Operating Procedures 13276

b Record Keeping 13280

c Personnel and Training 13284

d Calibration 13288

e Validation 13292

f Labeling 13296

g Error Management 13300

h Quality Control Unit and Internal Audits 13304

i Facilities and Equipment 13308

j Process and Production Controls 13312

7 Information Management 13316

8 Common Violations 13320

C 13324

1 Hematopoietic Progenitor Cells 13328

a Sources 13332

b Indications 13336

c HLA Matching 13340

d Donor Registries and Networks 13344

e 13348

f Accrediting Organizations 13352

2 Other Cellular Therapies 13356

Outcomes Registries, Professional Associations and

Networks

Quality, Legal and Regulatory Issues in Transfusion Medicine and Transplantation

Transplant Organizations and Networks in the Regulation of Cellular and

Tissue Therapy Programs


a Organizational Aspects 13360

b Accreditation and Regulation 13364

3 Tissue Banks 13368

a Organizational Aspects 13372

b Accreditation and Regulation 13376

D 13380

1 Role of the Medical Director 13384

a Administrative 13388

b Clinical 13392

c Education 13396

2 Quality Assurance 13400

a Process Control 13404

b Error Management 13408

c Improving Transfusion Practice 13412

3 Regulatory and Accreditation Requirements 13416

a Food and Drug Administration 13420

b AABB 13424

c Joint Commission 13428

d College of American Pathologists 13432

4 Transfusion Committee 13436

a Membership 13440

b Functions 13444

c 13448

d Education 13452

E Other Administrative Issues 13455

10 Surgery Patients 13500

A Alternatives to Transfusion: Perioperative Blood Management 13504

1 Preoperative 13508

a Autologous Blood Donation 13512

b Anemia optimization 13516

i Iron 13520

ii Erythropoietin 13524

2 Intraoperative/Postoperative 13528

a Acute Normovolemic hemodilution 13532

b 13536

c 13540

B Hemostasis for Surgery/Invasive Procedures 13544

1 Preprocedure Blood Components 13548

a 13552

b Procedure-Related Bleeding 13556

i Central Venous Catheter 13560

ii Liver Biopsy 13564

iii Thoracentesis and Paracentesis 13568

iv 13572

Hospital Transfusion Services, Transfusion Committee and Quality Assurance

Oversight of Transfusion Policies, Procedures, and

Guidelines

Intraoperative autologous blood recovery and reinfusion (cell

salvage)

Postoperative autologous blood recovery and reinfusion

Common Laboratory tests of Hemostasis and Their

Relationship With Procedure-related Bleeding

Gastrointestinal Endoscopy and Biopsy


v 13576

vi Renal Biopsy 13580

vii 13584

viii Angiography 13588

2 Treatment of Bleeding 13592

a Local 13596

i 13600

ii Topical Agents 13604

iii Topical Sealants 13608

iv Topical Thrombin 13612

v Topical Antifibrinolytics 13616

b Generalized 13620

i Skin and Membrane 13624

ii Purpura and Soft Tissue 13628

iii 13632

iv DDAVP 13634

C Transfusion Therapy for Trauma and Burn Patients 13636

1 Shock 13640

a General Information and Definition 13644

b Hemorrhagic Shock and Classification 13648

i Acidosis 13652

ii Hypothermia 13656

iii Coagulopathy 13660

c Trauma Patient 13664

i Initial Resuscitation 13668

aa Damage Control 13672

ab Blood Component Therapy 13676

ac Hemostatic Agents 13680

ad Pharmacologic Agents 13684

ii Intraoperative 13688

aa Damage Control 13692

ab Temperature 13696

ac Blood Component Therapy 13700

ad Autotransfusion 13704

ae Solid Organ Injury 13708

af Hemostatic Agents 13712

ag Pharmacologic Agents 13716

iii Recovery Phase 13720

aa Blood Component Therapy 13724

iv Massive Transfusion 13728

aa Definition 13732

ab Blood Component Therapy 13736

ac Complications 13740

d Burn Patient 13744

i Initial Resuscitation 13748

aa Fluid Therapy 13752

1 Colloid 13756

Procedures on Upper Airway, Bronchoscopy, and

Transbronchial Lung Biopsy

Epidural Anesthesia, Lumbar Puncture, and

Neurosurgical Procedures

Physical – Sutures, Electrocautery, Compression,

Direct Packing, etc

Small Vessel Bleeding During Surgery


2 Crystalloid 13760

ab Transfusion Therapy 13764

ac Hemostatic Agents 13768

ad Pharmacologic Agents 13772

D Transfusion Therapy in Solid Organ Transplantation 13776

1 Organ Procurement and Transplants 13780

2 Immunologic Barriers – ABO and HLA 13784

a Management Across Immunologic Barriers 13788

b Organ Selection 13792

c Plasma Exchange 13796

d Pharmacologic Agents 13800

3 Immunohematology 13804

a Patient Alloantibodies 13808

b Passenger Lymphocyte Antibodies 13812

4 Transfusion Therapy 13816

a Liver 13820

b Heart 13824

c Lung 13828

d Kidney 13832

e Pancreas 13836

f Other 13840

5 Special Needs 13844

a CMV Low Risk 13848

b Leukocyte Reduction 13852

c Irradiation 13856

11 Biovigilence & Transfusion-Related Immunomodulation 13900

A Biovigilance/Hemovigilance 13904

1 Requirements for Effective Program 13908

2 Scope 13912

a What Should Be Reported 13916

i Adverse Reactions 13920

ii Adverse Incidents 13924

iii Near Misses 13928

b Biovigilance 13932

i 13936

ii Traceability 13940

c Blood Donors 13944

d Transfusion Recipients 13948

B 13952

1 Concepts and Overview 13956

2 Laboratory Features 13960

3 Beneficial Clinical Effects 13964

a Enhanced Survival of Renal Allografts 13968

b 13972

c 13976

4 Deleterious Clinical Effects 13980

Passive Reporting Versus Active Surveillance

Immunomodulatory and Proinflammatory Effects of Allogeneic Blood

Transfusion

Reduced Risk of Recurrent Spontaneous Abortions

Reduced Risk of recurrence of Crohn’s Disease


a 13984

b 13988

c Increased Risk of Short-Term Mortality 13992

12 Platelets 14000

A Platelet Production (Thrombopoiesis) 14004

1 14008

2 14012

3 Genetic and Cellular Regulation of Thrombopoiesis 14016

4 Platelet Production/Shedding/Release 14020

B Platelet immunology 14024

1 Platelet Antigens (ABO, HLA, Platelet Specific) 14028

2 Disorders of Platelet Alloimmunization 14032

3 Platelet Autoimmunity 14036

C Platelets in the Bloodstream 14040

1 Platelet Circulation/Distribution/Destruction 14044

2 Platelet Survival/Kinetics in Health and Disease 14048

D Platelets and Hemostasis 14052

1 Normal Platelet Plug and Clot Formation 14056

2 Genetic/Congenital Platelet Disorders 14060

3 Acquired Platelet Disorders 14064

E Platelet Transfusions 14068

1 14072

2 14076

3 14080

13 Neutrophils 14100

A Neutrophil Production (Myelopoiesis) 14104

1 Neutrophil Development, Maturation and Differentiation 14108

2 Myelopoietic/Hematopoietic Growth Factors 14112

3 Genetic and Cellular Regulation of Myelopoiesis 14116

4 14120

B Neutrophil Immunology 14124

1 Neutrophil Antigens (ABO, HLA, Neutrophil Specific) 14128

2 14132

C Neutrophils and Infections 14136

1 Neutrophil Response to Infections 14140

2 Neutrophil Antimicrobial Functions 14144

3 Neutrophil Congenital and Acquired disorders 14148

D Neutrophil/Granulocyte Transfusions (Primarily Clinical Issues) 14152

1 Neutrophil Collection, Storage and Transfusion 14156

2 14160

Increased Recurrence of Resected Malignancies

Neutrophil Release, Compartments and Circulating Kinetics

Disorders of Neutrophil Alloimmunization and Autoimmunity

Alternatives to Neutrophil Transfusions (Myelopoietic Factors)

Increased Risk of Postoperative Bacterial Infection

Megakaryocyte Development, Maturation, and Differentiation

Thrombopoietic/Megakaryocyte/Hematopoietic Growth Factors

Collection and Storage of Platelet Preparations/Concentrates

Clinical Platelet Transfusions (Indications, Dose and Schedule)

Alternatives to Platelet Transfusions (Thrombopoietic and

Pharmacologic agents)


14 Intravascular Cell Kinetics 14200

A 14204

B 14208

C Use of Non-Radioactive Cellular Labels 14212

D Methods/Calculations for Determining Intravascular Cell Kinetics 14216

E Cell Kinetic Applications in Health and Disease 14220

15 Obstetric and Pediatric Patients 14300

A Obstetric Transfusion Practices 14304

1 Maternal Hematologic Disorders During Pregnancy 14308

2 14312

3 Fetal (Intrauterine) Transfusions 14316

B Hemolytic Disease of the Fetus and Newborn 14320

1 ABO Incompatibility 14324

2 Rh(D) and Other Fetal-Maternal RBC Incompatibilities 14328

3 14332

4 Management 14336

a Diagnostic and Surveillance Tests 14340

b 14344

C Congenital Disorders of Clotting and Anticoagulant Proteins 14348

1 Developmental Physiology of Plasma Proteins 14352

2 14356

a stet 13634

3 14360

4 14364

D Congenital Hemoglobinopathies and Hemolytic Anemias 14368

1 Sickle Cell Disease (Pathophysiology and Treatment) 14372

2 Non-Sickle Cell Hemoglobinopathies 14376

3 Thalassemias (Pathophysiology and Treatment) 14380

4 Congenital Red Cell Membrane and Enzyme Defects 14382

E Neonatal Transfusions 14384

1 Anemia of Prematurity (Pathophysiology and Treatment) 14388

2 14392

3 14396

4 14400

F Congenital Disorders of Hematopoiesis 14404

16 Hematopoietic Progenitor Cell (HPC) Transplantation 14500

A 14504

1 Autologous 14508

Concepts of Post-Transfusion Recovery and Tracking Labeled/Tracer cells

Techniques of Radiolabeling Blood Cells (RBCs, Platelets and Leukocytes)

Maternal Hemorrhage and Transfusions During Pregnancy

Neonatal Blood Banking Practices (Dedicated Units, WBC-Reduction,

Irradiation, etc)

Neonatal/Infant Plasma, Cryoprecipitate and Neutrophil Transfusions

Biology of Marrow Transplantation – Indications, Methods, Results, Adverse

Effects

Fetal RBC Membrane/Metabolic or Hemoglobin Abnormalities

Fetal and Neonatal Transfusions, Phototherapy, etc)

Hemophilia A, B and von Willebrand Disease (Pathophysiology and

Treatment)

Congenital Disorders of Non-Hemophilia Clotting Proteins

Congenital Disorders of Anticoagulant/Prothrombotic Proteins

Thrombocytopenia of Prematurity (Pathophysiology and Treatment)

DDAVP


2 Allogeneic / Syngeneic 14512

B Biology of HPC and HPC Transplantation 14516

1 HPC Biology 14520

2 Identification and Measurement of HPC 14524

3 14528

4 HLA Typing for HPC Transplantation 14532

5 Processing Requirements for HPC 14536

a General 14540

b Patient-Specific 14544

6 Regulatory, Compliance, Accreditation 14548

C HPC Sources and Collection 14552

1 HPC - Marrow 14556

a Methods of Harvesting 14560

b Characteristics, 14564

c Adverse Effects 14568

2 14572

a Biology of Stem Cell Mobilization 14576

b 14580

i Chemotherapy 14584

ii Growth Factors – G-CSF, GM-CSF 14588

iii Adhesion blockers – Plerixafor 14592

c 14596

d Monitoring Mobilization and HPC Collection 14600

e 14604

f 14608

3 14612

a 14616

b Cord Blood Unit Characteristics 14620

c 14624

4 14628

D 14632

1 HPC for Autologous Transplants 14636

2 14640

3 14644

4 Cord Blood 14648

5 14652

Allogeneic/Syngeneic Donor Selection, Qualification, Eligibility

HPC – Apheresis – Characteristics and Adverse effects

Donor Selection for Transplant (Unrelated and Related)

Selection of the Appropriate HPC Source for a Given Patient

HPC Processing - Goals, Guidelines, and Methods (preparation for infusion)

HPC for Allogeneic Transplant – Indications for Plasma, RBC

Reduction,

Preparation of Cells for Donor Lymphocyte Infusion (DLI)

Processing of Other CT Products (eg Antigen-Directed T cells,

Marrow Stromal Cells)

Mobilization Regimens (Indications, Dose, Schedule,

Efficacy, Adverse Effects)

Scheduling Mobilization and Apheresis Collection

Collection of Lymphocytes for Infusion (Donor Lymphocyte

Infusion; DLI)

Apheresis Considerations – Techniques, Vascular Access,

Donor Management, and Adverse Effects (Allogeneic vs

HPC - Cord Blood -

Characteristics, and Methods

Cord Blood Banking - Donor Eligibility, Collection Methods,

Processing, Testing, Cryopreservation


E HPC Storage and Preservation 14656

1 14660

2 Rationale for Cryopreservation 14664

3 Cryopreservation Theory and Practice 14668

a Cryoprotectants 14672

b 14676

c 14680

F 14684

1 14688

2 Patient Transfusion Management 14692

a 14696

b 14700

3 14704

4 Pediatric Considerations for Graft Manipulation 14708

G HPC Assessment - Pre- and Post-Processing and Post-Thaw 14712

1 Cell Counts and Methods 14716

2 HPC Measurement and Enumeration 14720

a 14724

b Non-Flow Methods 14728

3 HPC Viability Assessment Techniques 14732

4 HPC Cell Culture Assays 14736

5 HPC Functional and Differentiation Assays 14740

6 14744

H Cell Selection Methods and Applications 14748

1 14752

2 CD34 Cells and Others (eg Treg) 14756

3 Tumor Purging and T Cell Depletion 14760

I 14764

1 Direct HPC Infusion vs Pre-Infusion Cell Washing 14768

2 14772

J HPC and CTP infusion 14776

1 14780

2 14784

3 Management and Infusion of Contaminated Products 14788

K Engraftment 14792

Flow Cytometry CD34+ Cells and Other Markers (Single vs

Dual platform)

HPC Microbial Assessment - Gram Stain, Cultures - Aerobic,

Anaerobic, Fungal

Positive and Negative Selection - Techniques, Results, Indications

HPC and CTP Thawing and Post-Thaw Processing (Apheresis, Marrow, Cord

Blood, etc)

Special Considerations for Preparation of Cord Blood HPC for

infusion

Liquid Storage and Transport - Anticoagulant, Time, Temperature,

Preservative, Cell Concentration

Cryopreservaton Techniques – Controlled Rate, "Dump

Freeze"

Storage - Mechanical and Liquid Nitrogen (Vapor vs Liquid),

Management of RBC Antigen Incompatibility in Allogeneic Transplantation -

ABO/Rh, HLA, Other

Graft Management - Depletion of RBC (Major), Plasma (Minor)

Major or Minor ABO Incompatibility – Immediate vs Delayed

Hemolysis

Passenger Lymphocyte Syndrome (PLS), Cause, Diagnosis,

Course, Therapy, Prevention

Ablative vs Non-Ablative (Immunosuppressive) Conditioning

General Guidelines – Filters, No Irradiation, Infusion Rate, DMSO

Limits, Infusion Pumps

Adverse Effects and Infusion Reactions – Incidence, Causes,

Diagnosis, Management


1 14796

2 14800

3 Engraftment failure – Causes, Management 14804

4 Immune Reconstitution Post-Transplant 14808

5 Donor Lymphocyte Infusion – Rationale, Efficacy 14812

L 14816

1 14820

M 14824

N Experimental Cell Therapies 14828

1 Institutional vs Commercially Sponsored 14832

2 14836

3 14840

4 Regulatory Considerations 14844

Laboratory Administration - Staff Hiring and Training, Facilities, Equipment,

Supplies, Laboratory Development, Deviations, Non-Conforming HPC and

Types (eg Marrow Stromal, Adoptive Therapy with T Cells, Gene-

Modified Cells)

Special Requirements for Processing (Clean Room, etc)

Definition, Chimerism, Relationship to CD34+ Cell Doses

Rates - Autologous vs Allogeneic, Related vs MUD, HPC Source,

Conditioning

HPC Lab quality assurance and accreditation - AABB, FACT, CAP, NMDP

Regulatory Considerations – Federal GMP, GTP; State

Documents

Revised 8/2017 Blood Banking/Transfusion Medicine Major ...€¦ · 10 Surgery Patients 13500 11 Biovigilence & Transfusion-Related Immunomodulation 13900 ... 3 Cold Hemagglutinin