- Email: [email protected]
Introduction to Blood Banking and Transfusion Medicine
CHAPTER 1
Introduction to Blood Banking and Transfusion Medicine Christopher D. Hillyer, MD and Beth H. Shaz, MD A safe and reliable blood supply is critical to the function of complex healthcare systems worldwide. Blood transfusion is one of the most common therapeutic medical practices. The field of transfusion medicine (blood banking and transfusion services) has expanded to therapeutic apheresis, regenerative medicine, cellular therapy, tissue banking, and coagulation.
Blood Transfusion History: In 1667, Jean Denis published the transfusing of lamb blood (because of its presumed soothing qualities) to an agitated man (resulting in hemolytic transfusion reaction). In 1818, James Blundell first successfully transfused human blood to a patient with postpartum hemorrhage.
Blood Groups: Karl Landsteiner, in 1900, demonstrated the presence of the ABO blood group system. In the 1920s, ABO testing became routine. The Rh blood group system was discovered during 1939–40 by Landsteiner, Weiner, Levine, and Stetson, explaining many unexpected transfusion reactions cause. In 1945, Coombs, Mourant, and Race described antihuman globulin sera use to detect IgG antibodies in compatibility testing, thus providing the Coombs test.
Blood Storage: Direct transfusion (donor artery anastamosed to recipient vein) was performed in 1908, and direct transfusion using a three-way stopcock was used until World War II. While sodium citrate as an anticoagulant use was considered in 1914 and used (with glucose) some during World War I to set up blood depots, blood could be typically stored for a few days. In 1943, acid citrate dextrose solution allowed storage for weeks, facilitating blood “banking.” Additionally, acidification of anticoagulantpreservative solution allowed autoclaving and reduced bacterial contamination.
Blood Derivatives: In 1940, Cohn developed cold ethanol fractionation process, allowing plasma to be divided into albumin, gamma globulin, and fibrinogen, among other proteins (called Cohn fractionation). In 1961, Pool and Shannon recognized that the precipitate (cryoprecipitate) that formed when plasma was thawed in the cold contained factor VIII, revolutionizing hemophilia A treatment. In 1985, dry-heated, lyophilized factor VIII and IX concentrates became available. Genetically engineered (recombinant) factor VIII became available in 1993 and factor IX in 1998. Most recently, factor products are engineered without any human components. In 1967, Rh immune globulin was introduced commercially, near eliminating Rh hemolytic disease of the fetus and newborn.
Transfusion Medicine and Hemostasis. https://doi.org/10.1016/B978-0-12-813726-0.00001-5 Copyright © 2019 Elsevier Inc. All rights reserved.
3
4
Christopher D. Hillyer, MD and Beth H. Shaz, MD
Blood Component Therapy: Introduction of plastic bags to replace glass bottles for collection and storage in 1950 allowed development of component therapy with use of refrigerated centrifuges to separate components by density and precollection attached satellite bags to store the prepared components. This enabled optimal storage of each component and treatment of patients only with the component they needed.
Apheresis: In the 1950s, Cohn designed a centrifuge to separate cellular components from plasma. Donor apheresis allowed collection of therapeutic doses of platelets, granulocytes, RBCs, and plasma from a single donor. Automation of therapeutic apheresis devices has expanded its use, vital to the treatment of many diseases (e.g., thrombotic thrombocytopenic purpura, sickle cell disease).
Adverse Effects of Transfusion: Blood safety is continuously improved. In the 1960s, blood banks became increasingly aware that paid donors were associated with higher rates of hepatitis transmission, and by 1970, transition to an all-volunteer US blood supply began. In 1971, commercial testing for hepatitis B surface antigen began, further reducing posttransfusion hepatitis rate. In 1985, HIV antibody test was introduced. By 1990, testing for hepatitis C became routine and then HIV antigen testing was introduced. By 2000, nucleic acid testing for HIV and HCV in the developed world further reduced residual risk to ∼1:2,000,000 screened units. Subsequently, transmission of other emerging infection has become apparent, such as West Nile virus, Trypanosoma cruzi (agent of Chagas’ disease), and Babesia sp. Additional tests, donor screening, and pathogen reduction technologies have been implemented to sustain blood safety. Mitigation strategies for noninfectious transfusion complications, such as leukoreduction for febrile nonhemolytic transfusion reactions, donor screening and testing for transfusion-related acute lung injury, and irradiation for transfusion-associated graft versus host disease, have been implemented.
Donor Safety: Processes and studies have continued to improve donor safety, such as changing height and weight requirements for young donors to decrease vasovagal reactions. More recently, methods to mitigate iron deficiency in young and frequent donors are being researched and implemented.
Decade of “Right-Sizing” Utilization: Before 2008, blood utilization was increasing annually in most developed nations. By 2009, US blood transfusion approached 50 RBC units/100,000 inhabitants, while Canada was ∼30/100,000, Denmark ∼60/100,000 inhabitants, and Kenya <2/100,000. In 2009, significant decrease in blood utilization occurred in the United States and worldwide as patient blood management programs were implemented. US blood unitization decreased to ∼35/100,000 by 2016.
Blood Industry: The blood industry is the business relating to the pipeline (Fig. 1.1),
while the discipline is the medical field relating to the many processes in the pipeline. Blood industry includes manufacturers (also called suppliers) of information systems, reagents, appliances, and devices used by blood establishments, blood banks, transfusion services, and nongovernmental organizations (AABB, College of American Pathologists (CAP), National Marrow Donor Program (NMDP), and Foundation
5
Introduction to Blood Banking and Transfusion Medicine
Blood Center Imports
1
2
Loss
3
4
Testing
1. 2. 3. 4. 5. 6.
Hospital
5
1
6
Reference
Recruitment and booking Collections Manufacture Labeling General Inventory Distributions
2
3
Reference
Control Limit
1. 2. 3. 4. 5.
4
5
Control Limit
General Inventory Processing Cross-matched Issued Transfusion
FIGURE 1.1 The blood pipeline.
for the Accreditation of Cellular Therapy (FACT)). Advanced Medical Technology Association (AdvaMed), a trade association made up of medical technology companies, which has taken a leadership role in defining appropriate corporate–customer relationships for compliance with federal trade, financial and tax regulations, understanding of the challenges facing the industry as regard to government and third-party insurer reimbursement for blood and blood components.
Discipline: Blood banking and transfusion medicine has expanded to related laboratory disciplines, services, and therapeutics, including perioperative transfusion (perioperative autologous donation and cell salvage), therapeutic apheresis and phlebotomy, coagulation or specialized laboratories, hospital tissue banking, regenerative medicine, and cellular therapy—which itself includes collection, processing, storage, and distribution of hematopoietic progenitor cell products, pancreatic islet cells, and related minimally and highly manipulated cells. While credentialed as a single entity by the American Board of Pathology, blood banking and transfusion service terms have different meanings (transfusion medicine encompasses both terms).
Blood Banking: Blood banking refers to collection, processing, storage, and distribution of blood and blood components at a blood collection facility, defined by the FDA during registration or licensure as a community blood bank, although a small percentage of units are collected in the hospital setting, defined by the FDA as a hospital blood bank.
Transfusion Service: Transfusion service encompasses pretransfusion and compatibility testing; postmanufacture processing, including irradiation, washing, and volume reduction; and administration of appropriate products to appropriate patients at the
6
Christopher D. Hillyer, MD and Beth H. Shaz, MD
appropriate time. The transfusion service is mostly in hospitals (few centralized transfusion services exist in the United States serving multiple hospitals) usually under the FDA designation at registration as a hospital transfusion service. The transfusion service is typically responsible for clinical consultation regarding complex transfusion and coagulation issues, choice of specialized products, including coagulation factor concentrates, intravenous gamma globulin, and albumin, development of guidelines, and review of blood component therapy.
National Structure: Worldwide, the predominant healthcare structure is a national medical system with a national blood service. One example is the UK National Health Service Blood and Transplant, which provides blood (collection of blood and cellular therapies), transplantation, diagnostic, and therapeutic services as well as research and clinical trials. National blood and transfusion services typically formulate national transfusion guidelines and establish hemovigilance programs.
United States’ Structure: The United States has a network of ∼65 blood centers, some of which operate in multiple states (American Red Cross Biomedical Services, Blood Systems, New York Blood Center). Blood centers are members of several organizations, including America’s Blood Centers (ABC), Blood Centers of America (BCA), and AABB. AABB creates standards and performs accreditation in transfusion medicine and cellular therapies. AABB, in collaboration with other organizations, published guidelines for platelet, plasma, and RBC transfusions and developed a hemovigilance system for monitoring of donor and recipient adverse reactions and quality control incidents.
Further Reading Ellingson, K. D., Sapiano, M. R. P., Haass, K. A., Savinkina, A. A., Baker, M. L., Chung, K. W., et al. (2017). Continued decline in blood collection and transfusion in the United States-2015. Transfusion, 57(Suppl. 2), 1588–1598. Sapiano, M. R. P., Savinkina, A. A., Ellingson, K. D., Haass, K. A., Baker, M. L., Henry, R. A., et al. (2017). Supplemental findings from the national blood collection and utilization surveys, 2013 and 2015. Transfusion, 57(Suppl. 2), 1599–1624. Shaz, B. H., & Hillyer, C. D. (2010). Transfusion medicine as a profession: Evolution over the past 50 years. Transfusion, 50, 2536–2541.
Introduction to Blood Banking and Transfusion Medicine Christopher D. Hillyer, MD and Beth H. Shaz, MD A safe and reliable blood supply is critical to the function of complex healthcare systems worldwide. Blood transfusion is one of the most common therapeutic medical practices. The field of transfusion medicine (blood banking and transfusion services) has expanded to therapeutic apheresis, regenerative medicine, cellular therapy, tissue banking, and coagulation.
Blood Transfusion History: In 1667, Jean Denis published the transfusing of lamb blood (because of its presumed soothing qualities) to an agitated man (resulting in hemolytic transfusion reaction). In 1818, James Blundell first successfully transfused human blood to a patient with postpartum hemorrhage.
Blood Groups: Karl Landsteiner, in 1900, demonstrated the presence of the ABO blood group system. In the 1920s, ABO testing became routine. The Rh blood group system was discovered during 1939–40 by Landsteiner, Weiner, Levine, and Stetson, explaining many unexpected transfusion reactions cause. In 1945, Coombs, Mourant, and Race described antihuman globulin sera use to detect IgG antibodies in compatibility testing, thus providing the Coombs test.
Blood Storage: Direct transfusion (donor artery anastamosed to recipient vein) was performed in 1908, and direct transfusion using a three-way stopcock was used until World War II. While sodium citrate as an anticoagulant use was considered in 1914 and used (with glucose) some during World War I to set up blood depots, blood could be typically stored for a few days. In 1943, acid citrate dextrose solution allowed storage for weeks, facilitating blood “banking.” Additionally, acidification of anticoagulantpreservative solution allowed autoclaving and reduced bacterial contamination.
Blood Derivatives: In 1940, Cohn developed cold ethanol fractionation process, allowing plasma to be divided into albumin, gamma globulin, and fibrinogen, among other proteins (called Cohn fractionation). In 1961, Pool and Shannon recognized that the precipitate (cryoprecipitate) that formed when plasma was thawed in the cold contained factor VIII, revolutionizing hemophilia A treatment. In 1985, dry-heated, lyophilized factor VIII and IX concentrates became available. Genetically engineered (recombinant) factor VIII became available in 1993 and factor IX in 1998. Most recently, factor products are engineered without any human components. In 1967, Rh immune globulin was introduced commercially, near eliminating Rh hemolytic disease of the fetus and newborn.
Transfusion Medicine and Hemostasis. https://doi.org/10.1016/B978-0-12-813726-0.00001-5 Copyright © 2019 Elsevier Inc. All rights reserved.
3
4
Christopher D. Hillyer, MD and Beth H. Shaz, MD
Blood Component Therapy: Introduction of plastic bags to replace glass bottles for collection and storage in 1950 allowed development of component therapy with use of refrigerated centrifuges to separate components by density and precollection attached satellite bags to store the prepared components. This enabled optimal storage of each component and treatment of patients only with the component they needed.
Apheresis: In the 1950s, Cohn designed a centrifuge to separate cellular components from plasma. Donor apheresis allowed collection of therapeutic doses of platelets, granulocytes, RBCs, and plasma from a single donor. Automation of therapeutic apheresis devices has expanded its use, vital to the treatment of many diseases (e.g., thrombotic thrombocytopenic purpura, sickle cell disease).
Adverse Effects of Transfusion: Blood safety is continuously improved. In the 1960s, blood banks became increasingly aware that paid donors were associated with higher rates of hepatitis transmission, and by 1970, transition to an all-volunteer US blood supply began. In 1971, commercial testing for hepatitis B surface antigen began, further reducing posttransfusion hepatitis rate. In 1985, HIV antibody test was introduced. By 1990, testing for hepatitis C became routine and then HIV antigen testing was introduced. By 2000, nucleic acid testing for HIV and HCV in the developed world further reduced residual risk to ∼1:2,000,000 screened units. Subsequently, transmission of other emerging infection has become apparent, such as West Nile virus, Trypanosoma cruzi (agent of Chagas’ disease), and Babesia sp. Additional tests, donor screening, and pathogen reduction technologies have been implemented to sustain blood safety. Mitigation strategies for noninfectious transfusion complications, such as leukoreduction for febrile nonhemolytic transfusion reactions, donor screening and testing for transfusion-related acute lung injury, and irradiation for transfusion-associated graft versus host disease, have been implemented.
Donor Safety: Processes and studies have continued to improve donor safety, such as changing height and weight requirements for young donors to decrease vasovagal reactions. More recently, methods to mitigate iron deficiency in young and frequent donors are being researched and implemented.
Decade of “Right-Sizing” Utilization: Before 2008, blood utilization was increasing annually in most developed nations. By 2009, US blood transfusion approached 50 RBC units/100,000 inhabitants, while Canada was ∼30/100,000, Denmark ∼60/100,000 inhabitants, and Kenya <2/100,000. In 2009, significant decrease in blood utilization occurred in the United States and worldwide as patient blood management programs were implemented. US blood unitization decreased to ∼35/100,000 by 2016.
Blood Industry: The blood industry is the business relating to the pipeline (Fig. 1.1),
while the discipline is the medical field relating to the many processes in the pipeline. Blood industry includes manufacturers (also called suppliers) of information systems, reagents, appliances, and devices used by blood establishments, blood banks, transfusion services, and nongovernmental organizations (AABB, College of American Pathologists (CAP), National Marrow Donor Program (NMDP), and Foundation
5
Introduction to Blood Banking and Transfusion Medicine
Blood Center Imports
1
2
Loss
3
4
Testing
1. 2. 3. 4. 5. 6.
Hospital
5
1
6
Reference
Recruitment and booking Collections Manufacture Labeling General Inventory Distributions
2
3
Reference
Control Limit
1. 2. 3. 4. 5.
4
5
Control Limit
General Inventory Processing Cross-matched Issued Transfusion
FIGURE 1.1 The blood pipeline.
for the Accreditation of Cellular Therapy (FACT)). Advanced Medical Technology Association (AdvaMed), a trade association made up of medical technology companies, which has taken a leadership role in defining appropriate corporate–customer relationships for compliance with federal trade, financial and tax regulations, understanding of the challenges facing the industry as regard to government and third-party insurer reimbursement for blood and blood components.
Discipline: Blood banking and transfusion medicine has expanded to related laboratory disciplines, services, and therapeutics, including perioperative transfusion (perioperative autologous donation and cell salvage), therapeutic apheresis and phlebotomy, coagulation or specialized laboratories, hospital tissue banking, regenerative medicine, and cellular therapy—which itself includes collection, processing, storage, and distribution of hematopoietic progenitor cell products, pancreatic islet cells, and related minimally and highly manipulated cells. While credentialed as a single entity by the American Board of Pathology, blood banking and transfusion service terms have different meanings (transfusion medicine encompasses both terms).
Blood Banking: Blood banking refers to collection, processing, storage, and distribution of blood and blood components at a blood collection facility, defined by the FDA during registration or licensure as a community blood bank, although a small percentage of units are collected in the hospital setting, defined by the FDA as a hospital blood bank.
Transfusion Service: Transfusion service encompasses pretransfusion and compatibility testing; postmanufacture processing, including irradiation, washing, and volume reduction; and administration of appropriate products to appropriate patients at the
6
Christopher D. Hillyer, MD and Beth H. Shaz, MD
appropriate time. The transfusion service is mostly in hospitals (few centralized transfusion services exist in the United States serving multiple hospitals) usually under the FDA designation at registration as a hospital transfusion service. The transfusion service is typically responsible for clinical consultation regarding complex transfusion and coagulation issues, choice of specialized products, including coagulation factor concentrates, intravenous gamma globulin, and albumin, development of guidelines, and review of blood component therapy.
National Structure: Worldwide, the predominant healthcare structure is a national medical system with a national blood service. One example is the UK National Health Service Blood and Transplant, which provides blood (collection of blood and cellular therapies), transplantation, diagnostic, and therapeutic services as well as research and clinical trials. National blood and transfusion services typically formulate national transfusion guidelines and establish hemovigilance programs.
United States’ Structure: The United States has a network of ∼65 blood centers, some of which operate in multiple states (American Red Cross Biomedical Services, Blood Systems, New York Blood Center). Blood centers are members of several organizations, including America’s Blood Centers (ABC), Blood Centers of America (BCA), and AABB. AABB creates standards and performs accreditation in transfusion medicine and cellular therapies. AABB, in collaboration with other organizations, published guidelines for platelet, plasma, and RBC transfusions and developed a hemovigilance system for monitoring of donor and recipient adverse reactions and quality control incidents.
Further Reading Ellingson, K. D., Sapiano, M. R. P., Haass, K. A., Savinkina, A. A., Baker, M. L., Chung, K. W., et al. (2017). Continued decline in blood collection and transfusion in the United States-2015. Transfusion, 57(Suppl. 2), 1588–1598. Sapiano, M. R. P., Savinkina, A. A., Ellingson, K. D., Haass, K. A., Baker, M. L., Henry, R. A., et al. (2017). Supplemental findings from the national blood collection and utilization surveys, 2013 and 2015. Transfusion, 57(Suppl. 2), 1599–1624. Shaz, B. H., & Hillyer, C. D. (2010). Transfusion medicine as a profession: Evolution over the past 50 years. Transfusion, 50, 2536–2541.