CH13 Donor Screening

7/30/2019 CH13 Donor Screening

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Modern Blood Banking & Transfusion Practices6th Edition

Copyright 2012 F.A. Davis Company

Chapter 13

Donor Screening and Component

Preparation


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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 registrationrequirements to confirm donor identity and link

the donor to existing donor records Consent to donate

Additional information


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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


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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.


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Donor History Questionnaire (DHQ)

The currently approved version of the Donor

History Questionnaire (DHQ) can bedownloaded from the FDA website.


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The Physical Examination The donor center representative evaluates the

prospective donor with regard to General appearance

Weight

Temperature

Pulse Blood pressure

Hemoglobin

Skin lesions


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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.


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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.


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Autologous Donors (contd)

Disadvantages of autologous

donation/transfusion beyond the usual risks Bacterial contamination

Circulatory overload

Cytokine mediated reactions andproduct/recipient misidentification


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Methods for Obtaining

Autologous Blood

Preoperative collection

Acute normovolemic hemodilution

Intraoperative collection

Postoperative collection


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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.


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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.


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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.


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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


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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 FDAand AABB.

There must be a system to ensure that

confidentiality of the donor is notcompromised, 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


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Donor Processing (contd)

Anti-HIV-1/2 and NAT

Anti-HTLV-I/II

WNV RNA

Syphilis

T. Cruzi(Chagas Disease) Platelet bacterial detection


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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.


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Component Preparation (contd)

Whole blood

Irradiated whole blood

Rationale for limited number of whole blood

units

Red blood cells

RBC aliquots


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RBCs irradiated

RBCs leukoreduced

Frozen, deglycerolized RBCs

High glycerol (40% weight per volume)

Low glycerol (20% weight per volume)


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Platelet concentrates

Platelet aliquots

Platelets leukoreduced


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Single-donor plasma

Thawed plasma and liquid plasma

Cryoprecipitated antihemophilic factor


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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.


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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


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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


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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)



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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



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Factor VIII Concentrates (FVIII)

(contd)

If prepared from pooled plasma to inactivateor eliminate viral contamination

Pasteurization

Solvent/detergent treatment Monoclonal antibody purification



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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.



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Recombinant Factor VIII Produced by introducing human FVIII gene

(rFVIII) into baby hamster kidney cell lines,followed by purification and final

formulation.



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Factor IX Concentrates

Developed by monoclonal antibody

purification Available in three forms

Prothrombin complex concentrates

Factor IX concentrates Recombinant FIX



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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


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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


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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



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Plasma Protein Fraction (PPF)

Preparation similar to that of NSA, with fewer

purification steps Indicated for a variety of patient conditions



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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



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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.



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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.



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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

CH13 Donor Screening

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