Donor Screening and Component Preparation: 6 Edition

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

6th Edition
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

6th Edition
Plasma Protein Fraction (PPF)

Preparation similar to that of NSA, with fewer
purification steps

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 heat-
treated
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

Donor Screening and Component Preparation: 6 Edition

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Modern Blood Banking & Transfusion Practices

Donor Screening and Component

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Donor Screening (contd)

Copyright 2012 F.A. Davis Company

Medical History Questionnaire

Copyright 2012 F.A. Davis Company

Donor History Questionnaire (DHQ)

Copyright 2012 F.A. Davis Company

The Physical Examination

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Autologous Donors (contd)

Copyright 2012 F.A. Davis Company

Methods for Obtaining

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Apheresis Collection (contd)

Whole Blood Collection

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Donor Processing (contd)

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Component Preparation (contd)

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Plasma Derivatives (contd)

Copyright 2012 F.A. Davis Company

Plasma Derivatives (contd)

Copyright 2012 F.A. Davis Company

Activated Factor VII (Factor VIIa)

Copyright 2012 F.A. Davis Company

Factor VIII Concentrates (FVIII)

Factor VIII Concentrates (FVIII)

Copyright 2012 F.A. Davis Company

Porcine Factor VIII

Copyright 2012 F.A. Davis Company

Recombinant Factor VIII

Copyright 2012 F.A. Davis Company

Copyright 2012 F.A. Davis Company

Factor XIII Concentrates

Copyright 2012 F.A. Davis Company

Immune Serum Globulin

Copyright 2012 F.A. Davis Company

Normal Serum Albumin (NSA)

Copyright 2012 F.A. Davis Company

Plasma Protein Fraction (PPF)

Copyright 2012 F.A. Davis Company

Rho(D) Immune Globulin (RhIg)

Synthetic Volume Expanders

Copyright 2012 F.A. Davis Company

Antithrombin III Concentrates,