Understanding Transfusion Medicine

Transcription

1 Understanding Transfusion Medicine Every minute of every day, blood is on a critical journey A Reference Guide for Journalists

2 Overview of Transfusion Medicine Every second, three people across the world receive a blood transfusion 1,2. That means that every minute, at least 180 units of blood must be screened, typed, matched and safely transported along the chain that connects the generosity of a blood donor to the need of a patient. Behind the scenes, in laboratories and blood banks around the globe, thousands of skilled blood bankers work to ensure that safe, compatible blood is available where and when it s needed. While technology has made many routine blood bank tasks faster and easier, the demand for blood continues to rise and the pace of processing blood continues to accelerate. Hemovigilance and ensuring efficiency is of utmost importance to blood banks in maintaining a safe and accessible blood supply while keeping pace with accelerating demand for blood processing. This guide is intended to explain the complex process that ensures the right patient receives the right blood, at the right time, in the right way, for the right reasons. You may also find a helpful glossary toward the back of the document, for terms you may find unfamiliar.

3 Table of Contents Every minute of every day, blood is on a critical journey Background on Transfusion Medicine Who Receives Blood Transfusions?... 4 How is Blood Used?...5 Types of Blood Donations and Transfusions...5 Vein-to-Vein Management...5 Ensuring Blood Safety Screening Donors and Donated Blood... 6 Safety and Availability of Stored Blood...7 The Matching Game: Blood to Patient The Basics of Blood Typing... 8 Ensuring that the Right Patient Gets the Right Blood... 9 Looking to the Future...10 Glossary and Resources...11 Ortho Clinical Diagnostics History...14

4 Transfusion Medicine Background Who Receives Blood Transfusions? In the United States, more than 38,000 units of blood are required by hospitals and emergency treatment facilities every day, with a total of 30 million blood components transfused each year. 1 Data on the global use of donated blood is limited, but in 2007, 120 countries from across the globe reported 51,400 hospitals performing blood transfusions, serving a population of around 3.6 billion. 2 Generally, most blood and blood product transfusions are administered to people undergoing: Cancer treatment Orthopedic surgeries Organ and marrow transplants Cardiovascular surgeries Treatment for inherited blood disorders Due to aging populations and advances in medical treatments requiring blood transfusions, the demand for blood continues to increase.

5 How is Blood Used? Blood may be transfused whole or as one of its components. Because patients rarely need all of the components of whole blood, only the portion needed by the patient to treat a specific condition is normally transfused. This approach, called blood component therapy allows several patients to benefit from one unit of donated whole blood. A process called apheresis is used in the donation of specific blood components; this involves extracting the one component being donated and returning the remaining portion to the donor. Apheresis allows the collection of more of a particular component than would be possible from just one unit of whole blood. Types of Blood Donations and Transfusions The World Health Organization (WHO) estimates that around 92 million blood donations are given each year 3 to serve two types of blood transfusions - autologous and allogeneic. In autologous transfusions, patients receive their own blood, which is typically donated and stored prior to elective surgery and used after the surgery as needed. Allogeneic donations come from another person who is immunologically matched to some degree (e.g., by blood type) with a recipient. Most donated blood is from allogeneic donors and comes from three types of donations: 1) Voluntary and unpaid 2) Paid 3) Directed (i.e., donation is medically directed for a specific reason, such as to provide blood for a family member) Since the launch of the WHO s World Blood Donor Day in 2004, 111 countries have reported increased voluntary donations, which are considered safer than those that are paid. 4 As of 2011, 62 countries reported collecting 100% of their blood supplies from voluntary unpaid donors. 5 However, in 45 countries that number is less than 25%. 6 And 50% of the world s donations are from low- and middle-income countries where relatively fewer safe sources are available. In the United States, most of the roughly 16 million allogeneic blood donations each year come from volunteers. 7 However, while an estimated 38% of the U.S. population is eligible to donate blood, less than 10% do so annually. Vein-to-Vein Management Vein to Vein management refers to all aspects of blood transfusion from a donor entering a blood center where blood is drawn to the transfusion of blood into a recipient in a hospital ward as well as management of any transfusion-related complications, should they arise. The WHO states that the efficient coordination of blood transfusion services at a national level is a prerequisite for an effective and sustainable national blood screening program, 8 and 106 countries have national guidelines on appropriate clinical use of blood. 9 Nearly all countries have legislative provisions or guidelines on voluntary and unpaid blood donation. 10 In the United States, the Food and Drug Administration s (FDA) Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components for transfusions or for blood-based therapeutic products, such as clotting factors, and establishes standards for the products themselves. 11 In Europe, the Council of Europe regularly updates its Guide to the preparation, use and quality assurance of blood components. Aimed at blood banks and transfusion agencies, the guide describes a set of measures to guarantee the safety, quality and efficacy of blood components, and constitutes a fundamental benchmark in defining a gold standard for transfusion services. 12 As part of the UN Millennium Project to reverse the grinding poverty, hunger and disease affecting billions of people to be met internationally by 2015, 13 goals for blood safety and availability were included to achieve progress toward universal access to safe blood transfusion around the world.

6 Ensuring Blood Safety Screening Donors and Donated Blood Safety of donated blood or blood components starts with predonation screening, when a potential donor will answer questions about his or her health, lifestyle and disease risk factors. A short health exam follows, including the testing of a blood drop from a finger prick to ensure sufficient iron levels. All medical equipment used for donor screening and the donation itself is sterile, used only once and then disposed. 14 The next major step to ensure safety is screening the donated blood itself, at a minimum, for HIV, hepatitis B, hepatitis C and syphilis, as recommended by the WHO. According to 2008 screening data, 39 out of 164 submitting countries still do not routinely test blood donations for transfusion-transmissible infections. 15 Many countries do not have reliable testing systems due to staff shortages, lack of basic laboratory services or supplies, or poor quality test kits. Thus, standard practices for screening blood differ greatly across countries: 89% of donations are screened following basic quality procedures in developed countries, versus only 48% in developing countries. Further, complete and accurate data on the screening of donated blood is not available from many developing countries.

7 In the United States, donated blood is screened through a number of tests for possible donor infection including: Hepatitis B surface antigen (HBsAg) Hepatitis B core antibody (anti-hbc) Hepatitis C virus antibody (anti-hcv) HIV-1 and HIV-2 antibody (anti-hiv-1 and anti-hiv-2) HTLV-I and HTLV-II antibody (anti-htlv-i and anti-htlv-ii) West Nile virus (WNV) Serologic test for syphilis Nucleic acid amplification testing (NAT) for HIV-1, HCV and WNV Antibody test for Trypanosoma cruzi, the agent of Chagas disease Once blood units are tested, they are labeled clearly to be stored. Safe storage of whole blood and blood components is essential, and must adhere to the following requirements: Red blood cells can be stored under refrigeration for a maximum of 42 days or frozen for up to 10 years Platelets can be stored at room temperature for a maximum of five days Fresh frozen plasma can be kept frozen for up to one year Cryoprecipitate AHF made from fresh frozen plasma can be stored frozen for up to one year Granulocytes must be transfused within 24 hours of donation Blood and its components are shipped from blood banks to hospitals 24 hours a day, seven days a week. Any unit of blood that shows evidence of carrying a disease is safely discarded. The donor is notified not to donate blood again and to seek medical attention if appropriate. Safety and Availability of Stored Blood Although 92 million blood donations are collected globally each year, millions of patients needing transfusion do not have timely access to safe blood. 16 In the critical journey from donor to recipient, safe storage is integral to getting the right blood unit to the right patient at the right time.

8 The Matching Game: Blood to Patient The Basics of Blood Typing Safe blood transfusions depend on careful blood typing and crossmatching. There are eight common blood types based on the presence or absence of certain antigens or surface identifiers. Each patient has a different blood type, including ABO group (blood type) and Rh type (positive or negative). People are either A, B, AB or O blood type. A person with blood type B has only B antigens, whereas a person with type AB has both A and B antigens. Someone with blood type O has neither A or B antigens. Blood recipients can only receive blood from donors with compatible blood types because antibodies are produced against antigens not present in the body. Given the nature of blood typing, compatibility circumstances include the following: Recipients with type A or B blood should only get A or B blood, respectively as a match. Since recipients with type AB have both antigens, these universal recipients can receive blood of any type. As donors with type O blood do not have either A or B antigens, they are universal donors, and their blood can be given to recipients of any blood type (A, B, AB or O), but may only receive type O.

9 Rh factor is another important surface antigen that is typically tested. Its presence or absence is denoted as Rh positive or negative, respectively. There are many antigens besides A, B and Rh which are not part of routine screening. However, patients who have previously been pregnant or received a transfusion may have developed antibodies to one of these other antigens. This is determined by performing an antibody screening test, which involves mixing the patient s serum with red cells of a known antigenic makeup. To prevent a possible transfusion reaction, all future transfusions for that patient must first ensure that the donor s red blood cells do not have that particular antigen. Prior to transfusion, a unit of blood will be checked and matched to the patient s blood type by the lab staff. A nurse then prepares the patient by preparing an intravenous (IV) line; checking patient vital signs such as temperature, blood pressure and pulse prior to transfusion; and comparing the information on the patient s armband to the label on the unit of blood to confirm that he or she receives the correct blood product. After all safety checks are completed, the blood is transfused through the IV line. Transfusing one unit of red blood cells typically takes about 1.5 to 2 hours. Ensuring the Right Patient Gets the Right Blood Matching the right donor with the right recipient requires the highest degree of vigilance to ensure a safe transfusion. Matching a patient to the wrong blood can trigger a patient s immune system to attack the transfused blood, so it is vital to match donated blood accurately. The first step is a compatibility test to ensure that the right blood product has been identified. This includes ABO-Rh blood typing, antibody screening (for unexpected red blood cell antibodies that could cause a problem in the recipient) and cross-matching.

10 Looking to the Future Over the past two decades, the number of highly skilled technologists and scientists entering the transfusion medicine workforce has been shrinking. This is especially true for blood banking and transfusion medicine laboratories in the U.S., which have the highest overall vacancy rate (more than 11 percent 1 ) according to a recent report from the American Society for Clinical Pathology. The same study also found that for more than 20 percent of blood banking labs nationally, it can take more than one year to fill supervisor vacancies 17. Age is a key contributing factor to this shrinking pool of lab professionals. The average age of the laboratory worker today is about 50, and retirement is a key consideration. Lack of visibility and unfamiliarity with the profession are key factors preventing new workers from pursuing careers in laboratory science. As the labor force shrinks, the rapidly evolving field of laboratory medicine is struggling to keep pace with the growing demand for blood and its components. Automation is becoming a standard part of blood bank laboratories because it can eliminate many of the laborintensive, time-consuming manual testing processes involved in screening blood that require specialized skills and significant experience to master. Ultimately, automated testing can increase the lab s capacity, allowing it to serve more patients while helping it operate more efficiently, even with a smaller staff.

11 Glossary and Resources 18 Anemia The condition of having less than the normal number of red blood cells or less than the normal quantity of hemoglobin in the blood. or control bleeding in those with hemophilia and von Willebrand syndromes, the most common inherited major coagulation abnormalities. Donor The giver of a tissue or organ, for example, of blood or a kidney. Antigen A substance, usually a protein that can cause the immune system to produce antibodies against it. 19 Elective In medicine, a procedure or treatment that is chosen (elected) by the patient or physician that is advantageous to the patient but generally is not urgent. Apheresis The process of removing a specific component from blood and returning the remaining components to the donor, in order to collect more of one particular part of the blood than could be separated from a unit of whole blood. Also called emapheresis or pheresis. Blood bank A place where blood is collected from donors, typed, separated into components, stored and prepared for transfusion to recipients. A blood bank may be a separate free-standing facility or part of a larger laboratory in a hospital. Blood count The calculated number of white or red blood cells (WBCs or RBCs) in a cubic millimeter of blood. Blood group An inherited feature on the surface of the red blood cells. A series of related blood types constitute a blood group system such as the Rh or the ABO system. Granulocytes A type of white blood cell. Hemophilia A group of inherited bleeding disorders in which the ability of blood to clot is impaired. Hemovigilance A control process to survey all activities of the blood transfusion chain from donors to recipients with the aim of improving quality and increasing safety. 20 Hepatitis Inflammation of the liver from any cause. Hepatitis A Inflammation of the liver due to infection by the hepatitis A virus (HBA). Hepatitis A is usually transmitted through exposure to fecal material contaminated with the virus (e.g., through unwashed food). Cryoprecipitated antihemophilic factor (AHF) Cryoprecipitate is the portion of plasma-rich clotting factors. It is used to prevent

12 Hepatitis B Inflammation of the liver due to infection by the hepatitis B virus (HBV). Hepatitis B can be transmitted via blood products, needle sticks, body piercing and tattooing using unsterilized instruments, the dialysis process, sexual and even less intimate close contact and childbirth. Hepatitis C bloodstream of another person (the recipient). It can be autologous (from the same person) or allogeneic (from someone immunologically matched to some degree). Transfusion Safety Officer (TSO) A relatively new position developed in some nations to specifically identify, resolve and monitor organizational weakness leading to unsafe transfusion practice. 21 Inflammation of the liver due to infection by the hepatitis C virus (HCV), which is usually spread by blood transfusion and needle sticks. HIV Acronym for the Human Immunodeficiency Virus, the cause of AIDS (acquired immunodeficiency syndrome). A retrovirus, HIV has also been called the human lymphotropic virus type III, the lymphadenopathy-associated virus and the lymphadenopathy virus. Plasma The liquid part of the blood and lymphatic fluid, which makes up about half of its volume. Plasma is devoid of cells and, unlike serum, has not clotted. Blood plasma contains antibodies and other proteins. Protein A large molecule composed of one or more chains of amino acids in a specific order determined by the base sequence of nucleotides in the DNA coding for the protein. Red blood cell The blood cell that carries oxygen. Red cells contain hemoglobin which transports oxygen (and carbon dioxide). Transfusion The transfer of blood or blood components from one person (the donor) into the

13 Ortho-Clinical Diagnostics, Inc. Ortho Clinical Diagnostics delivers the high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to help them make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care.

14 Ortho Clinical Diagnostics History 1944: Dr. Philip Levine, a pioneer in the field of hematology, joined Ortho Clinical Diagnostics to continue his breakthrough research into the mechanics of the Rh system in human blood. This marked the beginning of the company s commitment to diagnostic medicine. Among Dr. Levine s many contributions was research that led to the development of Rh Immune Globulin to protect Rhnegative women against isoimmunization, saving the lives of thousands of babies. 1947: Developed the first blood bank anti-d test for the clinical market. This was a revolutionary advance in the burgeoning blood banking industry. 1968: Introduced RhoGAM Rho(D) Immune Globulin (Human), the first drug developed to prevent Rh hemolytic disease of the newborn. This major milestone in the history of medicine established the company s reputation as a leader in the field of immunohematology. 1977: Introduced MICRhoGAM Rho(D) Immune Globulin (Human), the first mini-dose. 1978: Introduced patented thin-film dry-slide technology, once again revolutionizing the field of diagnostics by providing clinical professionals with the means to receive high-quality results quickly, cleanly and economically 1989: Introduced the first test for the detection of antibodies to hepatitis C. 1996: Introduced the first test kit to screen blood for antigens to HIV-1, the virus that is responsible for the vast majority of AIDS cases in the U.S. 1997: Introduced the most advanced immunodiagnostic system available in the industry. The innovative VITROS ECi Immunodiagnostic System allows labs to conduct more sensitive tests such as thyroid, fertility, anemia, endocrinology and cardiology with greater speed, accuracy and cost-effectiveness. 1997: Introduced the Ortho AutoVue System, the first fully automated blood banking system in Europe. 1997: Introduced RhoGAM Ultra-Filtered Rho(D) Immune Globulin (Human). 1999: Introduced the Ortho Summit System, the first fully automated blood and plasma screening system available in the U.S. 1999:Became one of the first diagnostic industry suppliers to offer contracted implementation services that can significantly reduce clinical laboratory costs through operational efficiencies and streamlined processes. 1999: Became one of the first diagnostic industry suppliers to offer contracted implementation services for operational efficiencies and streamlined processes. 2000: Released the HCV Core Antigen ELISA Test System the first test commercially available for the direct detection of HCV core antigen in blood and plasma, a marker of early infection in hepatitis C-infected individuals. 2000: Established Advanced Cellular and Diagnostic Systems (now Veridex), an independently managed franchise focused on bringing high value diagnostic, monitoring and screening solutions to cancer and other disease states such as CNS and cardiovascular : Introduced RhoGAM Ultra-Filtered Rho(D) Immune Globulin (Human) in pre-filled syringes with safety shields in U.S., the first company to do so. 2001: Became the first diagnostic company to receive U.S. FDA approval for automated random access hepatitis tests, on the VITROS ECi Immunodiagnostic System. 2001: Developed Ortho trak-c, the world s first branded Total HCV Core Antigen test designed to provide reliable measures of HCV viremia that will lead to improvements in the management of patients with HCV infection. 2002: Acquired Micro Typing Systems of Pompano Beach, Florida, the manufacturer of the ID-Micro Typing System (ID-MTS) used in hospitals and donor centers to help to ensure safe and effective blood transfusions. 2003: Launched ORTHO ProVue Analyzer, the first fully automated Immunohematology system for use with the ID-Micro Typing System (ID-MTS) Gel Test in North America. 2004:Launched VITROS ECiQ Immunodiagnostic System and the Ortho AUTOVUE Innova Analyzer. 2004: Launched VITROS 5, 1 FS Chemistry System, raising industry standards for ease-of-use, integrity of results and operational efficiency. 2005: Launched VITROS 350 Chemistry System. 2006: Launched the first FDA licensed test to screen blood donations for exposure to Chagas disease. 2007: Launched VITROS, Troponin I ES Assay used along with other cardiac tests, to help diagnose a heart attack and to detect and evaluate heart injury. 2009: OCD launches FETALSCREEN II Fetal Maternal Hemorrhage Screening Test, a simple, qualitative test that detects D (Rho) positive fetal red blood cells in the maternal circulation of pregnant Rh-negative women 2009: OCD enters into an agreement with Avioq, Inc. to develop and commercialize a test in the U.S. to screen for antibodies to human T-lymphotropic virus (HTLV) type I and II OCD gains approval of the VITROS HBeAg assay a test for the Hepatitis B e antigen for use on the VITROS ECi/ECiQ Immunodiagnostic Systems in the United States 2011: OCD unveiled its new brand campaign, Bloodlines, inspired by the people behind the science of transfusion medicine the blood bankers who help protect precious life on the journey between blood donor and blood recipient. 2012: The Avioq 8745 HTLV-I/II Microelisa System assay becomes available, a new test developed by OCD in partnership with Avioq, Inc. to screen blood and organ donations for antibodies to human T-lymphotropic virus (HTLV) type I and II

15 References 1 World Health Organization. Blood safety and availability. Available at: int/mediacentre/factsheets/fs279/en/index.html. Accessed October 24, American Association of Blood Banks. Blood Donation Process. Available at: aabb.org/resources/donation/pages/bdprocess.aspx. Accessed October 16, World Health Organization, Blood Safety. Key global fact and figures in Available at Accessed November 7, World Health Organization, Blood Safety. Key global fact and figures in Available at Accessed November 7, American Red Cross. Blood Facts and Statistics. Available at: org/learn-about-blood/blood-facts-and-statistics. Accessed October 16, World Health Organization. Blood safety and availability. Available at: int/mediacentre/factsheets/fs279/en/index.html. Accessed October 24, World Health Organization, Blood Safety. Key global fact and figures in Available at Accessed November 7, World Health Organization. Fact File 10 Facts on Blood. Available at int/features/factfiles/blood_transfusion/blood_transfusion/en/index4.html. Accessed November 7, World Health Organization. Screening Donated Blood for Transfusion- Transmissible Infections. Available at ScreeningDonatedBloodforTransfusion.pdf. Accessed November 7, World Health Organization, Blood Safety. Key global fact and figures in Available at Accessed November 7, Edna Garcia, et al. (2000). American Society for Clinical Pathology s 2011 Vacancy Survey of U.S. Clinical Laboratories. (2011) LabMedicine, 42, MedicineNet.com. Blood Transfusion Glossary of Terms. Available at: medicinenet.com/blood_transfusion/glossary.htm. Accessed October 16, Medline Plus. Antigen. Available at: article/ htm. Accessed October 17, Teresa J. Nel. Managing Blood Transfusion Needs: Hemovigilance. Medscape Today. Available at: Accessed October 17, Dzik WH, Corwin H, et al. Patient safety and blood transfusion: new solutions. Transfus Med Rev Jul;17(3): Council of Europe. Fact sheet - World Blood Donor Day and the EDQM. Available at Accessed November 7, U.S. Food and Drug Administration. Blood and Blood Products. Available at: fda.gov/biologicsbloodvaccines/bloodbloodproducts/default.htm. Accessed October 16, Council of Europe. Fact sheet - World Blood Donor Day and the EDQM. Available at Accessed November 7, World Health Organization. Universal access to safe blood transfusion. Available at Accessed November 7, 2011