Modern Blood Banking Transfusion Practices Chapter 13 Donor
Modern Blood Banking & Transfusion Practices Chapter 13 Donor Screening and Component Preparation Copyright © 2012 F. A. Davis Company 6 th Edition
Modern Blood Banking & Transfusion Practices 6 th Edition 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) Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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 Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Donor Screening (cont’d) § Reasons for donor screening § Ensuring safety of the donation for the donor § Obtaining donor blood that will not transmit disease to the potential recipient Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Medical History Questionnaire § A standardized medical history questionnaire was developed by a task force that included representatives from AABB, FDA, and the blood and plasma industry. § Self-administered questionnaires must be reviewed by trained personnel prior to blood collection. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Donor History Questionnaire (DHQ) § The currently approved version of the Donor History Questionnaire (DHQ) can be downloaded from the FDA website. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices The Physical Examination § The donor center representative evaluates the prospective donor with regard to § § § § General appearance Weight Temperature Pulse Blood pressure Hemoglobin Skin lesions Copyright © 2012 F. A. Davis Company 6 th Edition
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Autologous Donors (cont’d) § Disadvantages of autologous donation/transfusion beyond the usual risks § Bacterial contamination § Circulatory overload § Cytokine mediated reactions and product/recipient misidentification Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices Methods for Obtaining Autologous Blood § § Preoperative collection Acute normovolemic hemodilution Intraoperative collection Postoperative collection Copyright © 2012 F. A. Davis Company 6 th Edition
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Apheresis Collection (cont’d) § Donor requirements are generally the same as for whole blood donation, although time intervals between donations can vary depending on the component collected. § The process is regulated by the FDA. § The AABB and the American Society for Apheresis (ASFA) provide standards. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Whole Blood Collection § Once the donor has satisfied requirements of the screening process and has been registered, whole blood collection proceeds. § § Donor identification Aseptic technique Collection procedure Post-donation instructions Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices Donor Processing § The processing tests performed on donor blood include the following § § § ABO/Rh Antibody screen HBs. Ag Anti-HBc Anti-HCV and NAT Copyright © 2012 F. A. Davis Company 6 th Edition
Modern Blood Banking & Transfusion Practices Donor Processing (cont’d) § § § Anti-HIV-1/2 and NAT Anti-HTLV-I/II WNV RNA Syphilis T. Cruzi (Chagas Disease) Platelet bacterial detection Copyright © 2012 F. A. Davis Company 6 th Edition
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Component Preparation (cont’d) § Whole blood § Irradiated whole blood § Rationale for limited number of whole blood units § Red blood cells § RBC aliquots Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Component Preparation (cont’d) § RBCs irradiated § RBCs leukoreduced § Frozen, deglycerolized RBCs § High glycerol (40% weight per volume) § Low glycerol (20% weight per volume) Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Component Preparation (cont’d) § Platelet concentrates § Platelet aliquots § Platelets leukoreduced Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Component Preparation (cont’d) § Single-donor plasma § Thawed plasma and liquid plasma § Cryoprecipitated antihemophilic factor Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Plasma Derivatives (cont’d) § Source Plasma is defined as plasma collected by plasmapheresis and intended for further manufacture into plasma derivatives. § Recovered Plasma is plasma recovered from whole blood donations that is shipped frozen to a manufacturer. § Cryoprecipitate is separated from the plasma and used for the production of Factor VIII concentrate. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Plasma Derivatives (cont’d) § The residual plasma is then separated into various proteins by manipulating the p. H, alcohol content, and temperature. § These products then undergo viral inactivation by any of several methods, including heat, solvent-detergent treatment, and nanofiltration. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Activated Factor VII (Factor VIIa) § Produced by recombinant DNA technology for § Patients with Hemophilia A who have circulating antibodies/inhibitors to Factor VIII § Patients with congenital Factor VII deficiency § Trauma, massive transfusion, and liver transplantation § Uncontrolled non-surgical hemorrhages after implantation of VAD (ventricular assist devices) Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Factor VIII Concentrates (FVIII) § Used to treat patients with Hemophilia A or classical hemophilia § Have almost completely replaced cryoprecipitate as the product of choice § May be prepared from large volumes of pooled plasma § More commonly prepared by recombinant DNA technology Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Factor VIII Concentrates (FVIII) (cont’d) § If prepared from pooled plasma to inactivate or eliminate viral contamination § Pasteurization § Solvent/detergent treatment § Monoclonal antibody purification Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Porcine Factor VIII § The xenographic form of Factor VIII is made from porcine plasma. § Beneficial for patients with Hemophilia A with inhibitors or antibodies to human Factor VIII. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Recombinant Factor VIII § Produced by introducing human FVIII gene (r. FVIII) into baby hamster kidney cell lines, followed by purification and final formulation. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices Factor IX Concentrates § Developed by monoclonal antibody purification § Available in three forms § Prothrombin complex concentrates § Factor IX concentrates § Recombinant FIX Copyright © 2012 F. A. Davis Company 6 th Edition
Modern Blood Banking & Transfusion Practices 6 th Edition Factor XIII Concentrates § Two plasma-derived virus inactivated factor XIII concentrates § An investigational new drug in the U. S. § A “named patient” basis drug in the U. K. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Immune Serum Globulin § A concentrate of plasma gamma globulins in an aqueous solution § Indicated for a variety of patient conditions Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Normal Serum Albumin (NSA) § Prepared from salvaged plasma, pooled and fractionated by a cold alcohol process, then treated with heat inactivation § Available in 25% or 5% solutions § Indicated for a variety of patient conditions Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Plasma Protein Fraction (PPF) § Preparation similar to that of NSA, with fewer purification steps § Indicated for a variety of patient conditions Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Rho(D) Immune Globulin (Rh. Ig) § A solution of concentrated anti-Rho(D) § Prepared from pooled human plasma of patients who have been hyperimmunized and contains predominantly Ig. G anti-D § Treatment of ITP and prevention of Rh HDN § Dosage and administration recommendations in prevention of Rh HDN Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Synthetic Volume Expanders § There are two categories of synthetic volume expanders: crystalloids and colloids. § Ringer’s lactate and normal isotonic saline comprise the crystalloids § Dextran and HES make up the colloid solutions § These solutions are useful in burn patients and in cases of hemorrhagic shock. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition Antithrombin III Concentrates, Antithrombin (AT) § Prepared from pooled human plasma and heattreated § Indicated for patients with hereditary AT deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism § A new recombinant AT concentrate (rh. AT) produced using transgenic technology has been developed on a compassionate-use basis. Copyright © 2012 F. A. Davis Company
Modern Blood Banking & Transfusion Practices 6 th Edition 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 Copyright © 2012 F. A. Davis Company
- Slides: 41