CH13 Donor Screening

Modern Blood Banking & Transfusion Practices
6th Edition
Chapter 13
Donor Screening and Component Preparation
Copyright 2012 F.A. Davis Company

6th 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)

6th 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

6th Edition
Donor Screening (contd)

Reasons for donor screening
Ensuring safety of the donation for the donor Obtaining donor blood that will not transmit disease to the potential recipient

6th 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.

6th Edition
Donor History Questionnaire (DHQ)

The currently approved version of the Donor History Questionnaire (DHQ) can be downloaded from the FDA website.

6th Edition
The Physical Examination

The donor center representative evaluates the prospective donor with regard to
General appearance Weight Temperature Pulse Blood pressure Hemoglobin Skin lesions

6th 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.

6th 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.

6th Edition
Autologous Donors (contd)

Disadvantages of autologous donation/transfusion beyond the usual risks
Bacterial contamination Circulatory overload Cytokine mediated reactions and product/recipient misidentification

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Methods for Obtaining Autologous Blood

Preoperative collection Acute normovolemic hemodilution Intraoperative collection Postoperative collection

6th 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.

6th 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.

6th Edition
Apheresis Collection (contd)

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.

6th 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

6th 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.

6th 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.

6th Edition
Donor Processing
The processing tests performed on donor blood include the following
ABO/Rh Antibody screen HBsAg Anti-HBc Anti-HCV and NAT

6th Edition
Donor Processing (contd)

Anti-HIV-1/2 and NAT Anti-HTLV-I/II WNV RNA Syphilis T. Cruzi (Chagas Disease) Platelet bacterial detection

6th 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.

6th Edition
Component Preparation (contd)

Whole blood
Irradiated whole blood Rationale for limited number of whole blood units
Red blood cells RBC aliquots

6th Edition

RBCs irradiated RBCs leukoreduced Frozen, deglycerolized RBCs
High glycerol (40% weight per volume) Low glycerol (20% weight per volume)

6th Edition

Platelet concentrates Platelet aliquots Platelets leukoreduced

6th Edition

Single-donor plasma Thawed plasma and liquid plasma Cryoprecipitated antihemophilic factor

6th 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.

6th Edition
Plasma Derivatives (contd)

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.

6th Edition
Plasma Derivatives (contd)

The residual plasma is then separated into various proteins by manipulating the pH, alcohol content, and temperature. These products then undergo viral inactivation by any of several methods, including heat, solvent-detergent treatment, and nanofiltration.

6th 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)

6th 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

6th Edition
Factor VIII Concentrates (FVIII) (contd)

If prepared from pooled plasma to inactivate or eliminate viral contamination
Pasteurization Solvent/detergent treatment Monoclonal antibody purification

6th 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.

6th Edition
Recombinant Factor VIII

Produced by introducing human FVIII gene (rFVIII) into baby hamster kidney cell lines, followed by purification and final formulation.

6th Edition
Factor IX Concentrates
Developed by monoclonal antibody purification Available in three forms
Prothrombin complex concentrates Factor IX concentrates Recombinant FIX

6th 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.

6th Edition
Immune Serum Globulin

A concentrate of plasma gamma globulins in an aqueous solution Indicated for a variety of patient conditions

6th 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

6th Edition
Plasma Protein Fraction (PPF)

Preparation similar to that of NSA, with fewer purification steps Indicated for a variety of patient conditions

6th Edition
Rho(D) Immune Globulin (RhIg)

A solution of concentrated anti-Rho(D) Prepared from pooled human plasma of patients who have been hyperimmunized and contains predominantly IgG anti-D Treatment of ITP and prevention of Rh HDN Dosage and administration recommendations in prevention of Rh HDN

6th Edition
Synthetic Volume Expanders

There are two categories of synthetic volume expanders: crystalloids and colloids.
Ringers 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.

6th 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 (rhAT) produced using transgenic technology has been developed on a compassionate-use basis.

6th 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

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Modern Blood Banking & Transfusion Practices

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Donor Screening (contd)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Medical History Questionnaire

Modern Blood Banking & Transfusion Practices

Donor History Questionnaire (DHQ)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

The Physical Examination

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Autologous Donors (contd)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Methods for Obtaining Autologous Blood

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Apheresis Collection (contd)

Modern Blood Banking & Transfusion Practices

Whole Blood Collection

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Modern Blood Banking & Transfusion Practices

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Donor Processing (contd)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Component Preparation (contd)

Red blood cells RBC aliquots

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Copyright 2012 F.A. Davis Company

Modern Blood Banking & Transfusion Practices

Plasma Derivatives (contd)

Modern Blood Banking & Transfusion Practices

Plasma Derivatives (contd)

Modern Blood Banking & Transfusion Practices

Activated Factor VII (Factor VIIa)

Modern Blood Banking & Transfusion Practices

Factor VIII Concentrates (FVIII)

Modern Blood Banking & Transfusion Practices

Factor VIII Concentrates (FVIII) (contd)