Physical Address

304 North Cardinal St.
Dorchester Center, MA 02124

Pretransfusion Testing

Pretransfusion testing is performed to select compatible blood components for transfusion, thereby preventing harm to recipient and maximizing posttransfusion survival. AABB Standards require the following: 1. Positive patient identification and their corresponding blood specimen; 2. ABO group and D typing of patient’s specimen; 3. Testing of patient’s serum/plasma for unexpected, clinically significant RBC antibodies, which are defined as non-ABO antibodies known to cause hemolytic transfusion reactions…

Role of the Transfusion Service Physician

According to the AABB Standards (Standard 1.0), the transfusion service (TS) must have a clearly defined structure and documentation of individuals responsible for key functions, including executive management. TS must have a medical director who is responsible for medical and technical policies, processes, and procedures. Hospital TS is typically within the departments of pathology and laboratory medicine (or clinical pathology). Specific Roles TS physician has multiple…

Bacterial Screening

Bacterial contamination of blood components may result in septic transfusion reactions ( Chapter 67 ), which can be fatal. Platelet products, particularly those on day 4 or 5 of storage, are most commonly associated with these reactions because they are stored at room temperature in nutrient media (plasma) enabling bacteria growth. Technologies have been developed to mitigate risk of bacterial contamination of platelet products, including methods…

Syphilis, Human T-Cell Lymphotropic Virus, and Chagas Screening

Testing blood donors for syphilis, human T-cell lymphotropic virus (HTLV), and Trypanosoma cruzi infection is mandated by the FDA and AABB Standards. Syphilis was the first transfusion-transmitted disease for which the blood supply was screened in the United States. HTLV is a retrovirus that can be transmitted by transfusion, and donor testing has mitigated the risk since put into place in 1988. Transfusion-transmitted Chagas disease, which…

Babesia Screening

Babesia microti is the leading red blood cell (RBC) transfusion-transmitted pathogen reported to the FDA. Babesiosis most commonly occurs after a tick bite but can be transfusion-transmitted and vertically transmitted. Owing to the increasing incidence of babesiosis and transfusion-transmitted babesiosis (TTB), testing of blood donors was implemented. Currently, there is no licensed test for blood donor screening for B.microti which can be performed at a blood…

Zika Virus Screening

In 2016, the association between maternal Zika viral infection and microcephaly in babies was recognized. Zika virus is spread through mosquitoes, sexual transmission, and potentially through transfusion. Owing to its associated morbidity, FDA recommended screening the blood supply by nucleic acid testing (NAT) or performing pathogen inactivation. To date, no Zika virus infection has been reported through transfusions in the United States; however, three infections have…

West Nile Virus Screening

West Nile virus (WNV), a single-stranded RNA flavivirus, is primarily spread by the mosquito Aedes albopictus. The only screening test used for WNV is nucleic acid testing (NAT), although IgG and IgM antibody testing may be used for donor counseling. Many donors have low viral copy numbers of circulating WNV, which result in false-negative testing by minipool (MP) NAT but can be identified by individual donor…

Hepatitis C Virus Screening

Hepatitis C virus (HCV) is primarily transmitted through blood exposure. It is a single-stranded RNA flavivirus, distinguished by a low rate of recognized acute infection and a high rate of chronic infection that results in substantial morbidity and mortality over long periods of observation. Because most infections are asymptomatic, testing blood donors is critical. Historically, any viral hepatitis that was not caused by hepatitis A or…

Hepatitis B Virus Screening

Hepatitis B virus (HBV) is a DNA virus from the family Hepadnaviridae . It is transmitted parenterally, sexually, and perinatally. Every blood donation is tested for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), and HBV nucleic acid testing (NAT). Donors may be permanently deferred if confirmed positive or temporarily deferred based on various testing scenarios. Posttransfusion hepatitis due to HBV was a common…

Human Immunodeficiency Virus Screening

Screening donated blood for human immunodeficiency virus (HIV) is critical to maintaining a safe blood supply. HIV transmission by intravenous administration of infected blood products proved to be highly efficient and accordingly, shortly after HIV-1 discovery in 1983, donor deferral measures were initiated and, in 1985, the first test was licensed for donor screening. Donor deferral and testing has decreased blood transfusion transmission from ∼1:100 transfused…

Overview of Infectious Disease Testing

Safe and available blood products are critical requirements for the optimal functioning of any advanced medical system. Ensuring blood product safety relies on active surveillance and timely recognition of emerging transfusion-transmissible infections, recruitment and selection of low-risk donors, robust donor screening using risk based deferral and laboratory testing for infectious disease markers, and application of good manufacturing practices, rigorous quality, accreditation, and inspection systems. Collectively, these…

Serologic Testing of Donor Products

Each blood component must have its ABO and D antigen status tested as a primary mechanism of preventing ABO-incompatible blood transfusions and D antigen sensitization. Additionally, components must be tested for the presence of unexpected, clinically significant antibodies to prevent potential recipient hemolysis. Red blood cell (RBC) products often undergo further RBC antigen characterization to supply blood products for patients with alloantibodies or patients with chronic…

Component Preparation and Manufacturing

Blood components, including red blood cell (RBC), plasma, platelet, and granulocyte products, are prepared either from whole blood (WB) or by automated apheresis donation. Component preparation and manufacturing allow each component to be manufactured and stored under optimal conditions. Component therapy has largely replaced WB due to ability to choose components that target specific patient’s needs and enable each component to be stored optimally. Additionally, components…

Adverse Donor Reactions

About 2%–5% of whole blood donors experience some form of reaction although most are mild vasovagal reactions and small hematomas. Reactions are more likely to occur in young (≤20 years old), low weight/blood volume, first-time, and female donors. Vasovagal reactions are most common, which, when moderate to severe, can lead to loss of consciousness (LOC), seizure-like activity, and severe injury secondary to a fall. More rarely,…

Recipient-Specific Blood Donation

Recipient-specific blood components are typically donated in three circumstances: exceptional medical need, directed donation, and autologous donations. Aside from specific donor qualifications, evaluating need and appropriate use of these specific components requires balanced medical oversight and optimal communication between ordering physician, transfusion service medical director, and collection facility medical director. Exceptional medical need exists when blood or appropriate components are collected for a specific patient who…

Apheresis Blood Component Collections

In the United States, 14% of RBC, 12% of plasma, and 91% of platelet products collected in 2015 were collected by apheresis procedures (for granulocyte products, see Chapter 7 ). Manufacture of blood components by apheresis provides many advantages over whole blood (WB) collection. Apheresis collections are already leukoreduced, available for component therapy without further processing, and product type, volume, dose, and number controlled. Apheresis collection…

Blood Donation

In the United States, ∼14 million units of whole blood (WB) are collected each year from ∼7 million donors. The blood is processed into blood components (RBCs, platelets, plasma, and cryoprecipitate) and used in the treatment of surgical, obstetric, medical, and other patients. The blood donation process includes donor recruitment, eligibility, screening, collection, and postdonation care and is (1) overseen by a licensed, qualified physician, (2)…

Role of the Physician in the Blood Center

Physicians play a central role in blood centers with direct and indirect responsibilities. The physician’s role actively participates in the blood center activities, including collection, manufacturing, storage, and distribution of biologics (cellular therapies and blood components), and, in some cases, infectious disease testing, reference laboratories, therapeutics (apheresis, cell salvage), and research ( Fig. 4.1 ). Blood centers serve a humanitarian need, and mission statements of blood…

Regulatory Issues in Transfusion Medicine

Transfusion medicine is a highly regulated industry, and regulatory oversight has and continues to be a major factor in most aspects of operations. Although in the United States, the Food and Drug Administration (FDA) is the primary regulator, a number of other state and federal agencies participate in regulating both blood banks and transfusion services. FDA registration and/or licensure is a requirement for those blood banks…

Quality Principles in Transfusion Medicine

Quality, as defined in the field of blood banking and transfusion medicine, has evolved from a focus on retrospective auditing and review of sampling and testing. This evolution began with a focus on compliance and meeting minimal regulations, standards, and guidelines of accrediting and regulating agencies. More recently, it moved to a focus on compliance leveraged with proactive and direct involvement in, and construction of, quality…