ch13 donor screening
TRANSCRIPT
-
7/30/2019 CH13 Donor Screening
1/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Chapter 13
Donor Screening and Component
Preparation
-
7/30/2019 CH13 Donor Screening
2/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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)
-
7/30/2019 CH13 Donor Screening
3/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Donor Screening Donor screening encompasses the donor
medical history, mini physical examination,and serologic testing of the donor blood.
Donor identification and registrationrequirements to confirm donor identity and link
the donor to existing donor records Consent to donate
Additional information
-
7/30/2019 CH13 Donor Screening
4/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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
-
7/30/2019 CH13 Donor Screening
5/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Medical History Questionnaire
A standardized medical history questionnaire
was developed by a task force that includedrepresentatives from AABB, FDA, and theblood and plasma industry.
Self-administered questionnaires must bereviewed by trained personnel prior to bloodcollection.
-
7/30/2019 CH13 Donor Screening
6/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Donor History Questionnaire (DHQ)
The currently approved version of the Donor
History Questionnaire (DHQ) can bedownloaded from the FDA website.
-
7/30/2019 CH13 Donor Screening
7/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
The Physical Examination The donor center representative evaluates the
prospective donor with regard to General appearance
Weight
Temperature
Pulse Blood pressure
Hemoglobin
Skin lesions
-
7/30/2019 CH13 Donor Screening
8/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Informed Consent
AABB Standards mandates that informed
consent of allogeneic, autologous, andapheresis donors be obtained.
The donor must be informed of the risks of
the procedure and also of the tests that areperformed to reduce the risk of infectious
disease transmission to the recipient.
-
7/30/2019 CH13 Donor Screening
9/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Autologous Donors Most autologous blood is used to treat surgical
blood loss in very specific situations where there is areasonable opportunity to avoid homologous
transfusions and/or when compatible allogeneic
blood is not available.
Advantages include decreased risk of diseasetransmission, transfusion reactions, and
alloimmunization.
-
7/30/2019 CH13 Donor Screening
10/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Autologous Donors (contd)
Disadvantages of autologous
donation/transfusion beyond the usual risks Bacterial contamination
Circulatory overload
Cytokine mediated reactions andproduct/recipient misidentification
-
7/30/2019 CH13 Donor Screening
11/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Methods for Obtaining
Autologous Blood
Preoperative collection
Acute normovolemic hemodilution
Intraoperative collection
Postoperative collection
-
7/30/2019 CH13 Donor Screening
12/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Directed Donation
A directed donation is collected under the
same requirements as allogeneic donors, butis 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 beirradiated to prevent GVHD.
A system should be in place to ensure directedunits from blood relatives are irradiated.
-
7/30/2019 CH13 Donor Screening
13/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Apheresis Collection A means for collecting a specific blood component
while returning the remaining whole bloodcomponents 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.
-
7/30/2019 CH13 Donor Screening
14/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Apheresis Collection (contd)
Donor requirements are generally the same
as for whole blood donation, although timeintervals 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.
-
7/30/2019 CH13 Donor Screening
15/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Whole Blood Collection
Once the donor has satisfied requirements of
the screening process and has beenregistered, whole blood collection proceeds.
Donor identification
Aseptic technique
Collection procedure
Post-donation instructions
-
7/30/2019 CH13 Donor Screening
16/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
-
7/30/2019 CH13 Donor Screening
17/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Donor Records
Donor records must be retained by the blood
collection facility as mandated by the FDAand AABB.
There must be a system to ensure that
confidentiality of the donor is notcompromised, and that donor records are not
altered.
-
7/30/2019 CH13 Donor Screening
18/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Donor Processing
The processing tests performed on donor
blood include the following ABO/Rh
Antibody screen
HBsAg Anti-HBc
Anti-HCV and NAT
-
7/30/2019 CH13 Donor Screening
19/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Donor Processing (contd)
Anti-HIV-1/2 and NAT
Anti-HTLV-I/II
WNV RNA
Syphilis
T. Cruzi(Chagas Disease) Platelet bacterial detection
-
7/30/2019 CH13 Donor Screening
20/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
-
7/30/2019 CH13 Donor Screening
21/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Component Preparation (contd)
Whole blood
Irradiated whole blood
Rationale for limited number of whole blood
units
Red blood cells
RBC aliquots
-
7/30/2019 CH13 Donor Screening
22/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Component Preparation (contd)
RBCs irradiated
RBCs leukoreduced
Frozen, deglycerolized RBCs
High glycerol (40% weight per volume)
Low glycerol (20% weight per volume)
-
7/30/2019 CH13 Donor Screening
23/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Component Preparation (contd)
Platelet concentrates
Platelet aliquots
Platelets leukoreduced
-
7/30/2019 CH13 Donor Screening
24/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Component Preparation (contd)
Single-donor plasma
Thawed plasma and liquid plasma
Cryoprecipitated antihemophilic factor
-
7/30/2019 CH13 Donor Screening
25/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Plasma Derivatives
Plasma derivatives are different from blood
components because they are prepared byfurther manufacture of pooled, human
source and recovered plasma.
Recombinant DNA technology or monoclonalantibody purification may also be utilized in their
preparation.
-
7/30/2019 CH13 Donor Screening
26/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Plasma Derivatives (contd) Source Plasma is defined as plasma collected by
plasmapheresis and intended for furthermanufacture 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 ofFactor VIII concentrate.
M d Bl d B ki & T f i P i
-
7/30/2019 CH13 Donor Screening
27/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
28/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Activated Factor VII (Factor VIIa)
Produced by recombinant DNA technology for
Patients with Hemophilia A who have circulatingantibodies/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)
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
29/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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 DNAtechnology
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
30/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Factor VIII Concentrates (FVIII)
(contd)
If prepared from pooled plasma to inactivateor eliminate viral contamination
Pasteurization
Solvent/detergent treatment Monoclonal antibody purification
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
31/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
32/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Recombinant Factor VIII Produced by introducing human FVIII gene
(rFVIII) into baby hamster kidney cell lines,followed by purification and final
formulation.
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
33/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Factor IX Concentrates
Developed by monoclonal antibody
purification Available in three forms
Prothrombin complex concentrates
Factor IX concentrates Recombinant FIX
M d Bl d B ki & T f i P ti
-
7/30/2019 CH13 Donor Screening
34/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
Modern Blood Banking & Transf sion Practices
-
7/30/2019 CH13 Donor Screening
35/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Immune Serum Globulin
A concentrate of plasma gamma globulins in
an aqueous solution Indicated for a variety of patient conditions
Modern Blood Banking & Transfusion Practices
-
7/30/2019 CH13 Donor Screening
36/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Normal Serum Albumin (NSA)
Prepared from salvaged plasma, pooled and
fractionated by a cold alcohol process, thentreated with heat inactivation
Available in 25% or 5% solutions
Indicated for a variety of patient conditions
Modern Blood Banking & Transfusion Practices
-
7/30/2019 CH13 Donor Screening
37/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Plasma Protein Fraction (PPF)
Preparation similar to that of NSA, with fewer
purification steps Indicated for a variety of patient conditions
Modern Blood Banking & Transfusion Practices
-
7/30/2019 CH13 Donor Screening
38/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
Rho(D) Immune Globulin (RhIg)
A solution of concentrated anti-Rho(D)
Prepared from pooled human plasma ofpatients 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
Modern Blood Banking & Transfusion Practices
-
7/30/2019 CH13 Donor Screening
39/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
Modern Blood Banking & Transfusion Practices
-
7/30/2019 CH13 Donor Screening
40/41
Modern Blood Banking & Transfusion Practices6th Edition
Copyright 2012 F.A. Davis Company
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.
Modern Blood Banking & Transfusion Practices
-
7/30/2019 CH13 Donor Screening
41/41
Modern Blood Banking & Transfusion Practices6th Edition
Labeling of Components Components must be labeled in accordance
with AABB Standards, FDA regulations, andInternational Society of Blood Transfusion(ISBT) Code 128 requirements.
Donor Identification Number (DIN),
product/donor linking, and labelingrequirements for volunteer and autologouscomponents