Professional Documents
Culture Documents
6th Edition
Chapter 13
Donor Screening and Component Preparation
Governing Agencies
Governing agencies for processes including donor selection and donor unit processing
U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) American Association of Blood Banks (AABB) College of American Pathologists (CAP)
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Donor Screening
Donor screening encompasses the donor medical history, mini physical examination, and serologic testing of the donor blood.
Donor identification and registration requirements to confirm donor identity and link the donor to existing donor records Consent to donate Additional information
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Informed Consent
AABB Standards mandates that informed consent of allogeneic, autologous, and apheresis donors be obtained. The donor must be informed of the risks of the procedure and also of the tests that are performed to reduce the risk of infectious disease transmission to the recipient.
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Autologous Donors
Most autologous blood is used to treat surgical blood loss in very specific situations where there is a reasonable opportunity to avoid homologous transfusions and/or when compatible allogeneic blood is not available. Advantages include decreased risk of disease transmission, transfusion reactions, and alloimmunization.
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Directed Donation
A directed donation is collected under the same requirements as allogeneic donors, but is directed toward a specific patient.
The tag for the directed unit is a distinct color. If the donor is a blood relative, the unit must be irradiated to prevent GVHD. A system should be in place to ensure directed units from blood relatives are irradiated.
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Apheresis Collection
A means for collecting a specific blood component while returning the remaining whole blood components back to the patient. Blood separated into components with centrifugal force based on differences in density. Can be used to collect large volumes of the intended component, such as platelets, plasma, white cells, red cells, and stem cells.
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Donor Reactions
Reactions can be divided into three categories
Mild reactions Moderate reactions Severe reactions
The donation center staff should also be prepared to properly treat hematomas.
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Donor Records
Donor records must be retained by the blood collection facility as mandated by the FDA and AABB. There must be a system to ensure that confidentiality of the donor is not compromised, and that donor records are not altered.
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Donor Processing
The processing tests performed on donor blood include the following
ABO/Rh Antibody screen HBsAg Anti-HBc Anti-HCV and NAT
Component Preparation
A single blood donation can provide transfusion therapy to multiple patients in the form of RBCs, platelets, fresh frozen plasma, cryoprecipitate, and other components. The AABB Standards address the preparation, quality indicators, and storage requirements for all component products.
Plasma Derivatives
Plasma derivatives are different from blood components because they are prepared by further manufacture of pooled, human source and recovered plasma.
Recombinant DNA technology or monoclonal antibody purification may also be utilized in their preparation.
Factor IX Concentrates
Developed by monoclonal antibody purification Available in three forms
Prothrombin complex concentrates Factor IX concentrates Recombinant FIX
These solutions are useful in burn patients and in cases of hemorrhagic shock.
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Labeling of Components
Components must be labeled in accordance with AABB Standards, FDA regulations, and International Society of Blood Transfusion (ISBT) Code 128 requirements.
Donor Identification Number (DIN), product/donor linking, and labeling requirements for volunteer and autologous components
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