82043_color_plates.

qxd 11/12/09 7:18 AM Page xix

Father Mother
a b c d
A1 A2 A11 A3

B8 B44 B35 B7

DR3 DR4 DR1 DR2

a c a d b c
A1 A11 A1 A3 A2 A11

B8 B35 B8 B7 B44 B35

DR3 DR1 DR3 DR2 DR4 DR1

b d a c a/b c
A2 A3 A1 A11 A1 A11

B44 B7 B8 B35 B44 B35

DR4 DR2 DR3 DR1 DR4 DR1

COLOR PLATE C-4 The inheritance of HLA haplotypes. a and b denote paternal haplotypes, and c and d denote
maternal haplotypes. a/b denote a paternal recombinant haplotype derived from a recombination event occurring
between the HLA-A and HLA-B locus.
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Villus Intervillus space Uterus

Amniotic fluid

Placenta
(see details Fetal Maternal
in Color Plate circulation circulation
C-6)

Umbilical cord Positive Negative

cells cells

Fetus

Uterine wall
COLOR PLATE C-5 Fetus and placenta. (From Blood
Group Antigens and Antibodies as Applied to Hemolytic
Disease of the Newborn. Raritan, NJ: Ortho Diagnostics,
Inc.; 1968, with permission.)
Amnio Umbilical Chorion Trophoblast Maternal
vessels vessels
COLOR PLATE C-6 Scheme of placental circulation.
White arrows depict separate routines of fetal and maternal
circulations within the placenta. Dotted lines represent
oxygen nutrient and waste exchange through the placental
barrier. (From Blood Group Antigens and Antibodies as
Applied to Hemolytic Disease of the Newborn. Raritan, NJ:
Ortho Diagnostics, Inc.; 1968, with permission.)

Fetal Maternal
circulation circulation

Positive Invading
COLOR PLATE C-7 Separation of placenta following fetal
cells
delivery. Diagram portrays the rupture of placental (positive)
vessels (villi) and connective tissues allowing escape cells
of fetal blood cells. Prior to complete constriction of
the open-end maternal vessels, some fetal blood may
enter maternal circulation. (From Blood Group Antigens
and Antibodies as Applied to Hemolytic Disease of the
Newborn. Raritan, NJ: Ortho Diagnostics, Inc.; 1968,
with permission.)
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UNIT 1 | BLOOD AND BLOOD CHAPTER

COMPONENTS
1
BLOOD COLLECTION AND
PROCESSING
JEAN STANLEY

OBJECTIVES Standard operating

procedures
Traceability
Uniform donor history
After completion of this chapter, the reader will be able to: Surrogate markers questionnaire (UDHQ)
1. List information necessary for registration of a donor. Syncope Volunteer blood donors
2. Discuss the importance of the uniform donor history ques- Therapeutic phlebotomy Window period
tionnaire and the accompanying documents for prospec-
tive donors.
3. Define the importance of a medical history and physical
examination for determining donor acceptability. B lood is a scarce resource, with its availability de-
pendent upon the altruistic nature of volunteer
blood donors. All blood in the United States collected
4. Explain the procedure for phlebotomy of a donor.
for the transfusion of others or allogeneic donations
5. Describe various types of donor reactions and appropriate
comes from volunteer blood donors. With the addi-
steps to follow to aid the donor.
tion of numerous screening questions and sophisti-
6. List the testing requirements for donor processing. cated tests to ensure the safety of the blood supply,
7. Discuss the preoperative autologous donation procedure, it is estimated that only 38% of the U.S. population
including testing and labeling requirements. is eligible to donate blood.1 Volunteer blood donors
8. Describe the other methods of collecting autologous provide red blood cells (RBCs), plasma, and platelets,
donations. each an important component in helping to save lives
through blood transfusions. With the diminishing
pool of available blood donors, blood centers and
blood banks have the responsibility to provide a safe
KEY WORDS and pleasant environment to recruit and retain donors
so that blood and blood components will be available
Allogeneic Hematocrit for the patients requiring transfusions.
Autologous Hemoglobin The donation process is guided by requirements or
Chagas High-risk donor standards AABB, formly known as American Associa-
tion of Blood Banks, a professional organization with
Confidential unit exclusion Infectious disease markers
expertise in standard setting and accreditation in blood
Dedicated donor Intraoperative salvage banking and transfusion medicine, and the Depart-
Deferral ISBT 128 ment of Health and Human Services, U.S. Food and
Directed donor Mobile operation Drug Administration (FDA). These stringent require-
ments must be followed by facilities collecting and dis-
Donor processing Nucleic acid testing
tributing blood and blood components, ensuring the
Good manufacturing Paid donor donation process is safe for the donor as well as the
practices Postoperative salvage blood received for transfusion is safe for the recipient.

1
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2 UNIT 1 Blood and Blood Components
To ensure the safety of both parties, good manufactur-
ing practices (GMPs) must be incorporated into an
organization’s operations. GMPs are a set of regula-
tions enforced by the FDA to ensure that each step in
the manufacturing process is controlled, from the be-
ginning to the end.2 Every operational department in
a facility must have standard operating procedures
(SOPs) that describe instructions to staff on how to
perform each step in the blood collection and manu-
facturing process.3 The SOPs should reflect any local,
state, and federal regulations pertaining to blood bank
operations.
RECRUITMENT OF DONORS
The donation process begins with the recruitment of
volunteer donors and scheduling of appointments,
which may occur via telephone calls, electronically on
a blood organization’s web site or by email, or through
presentations at company businesses. Many busi-
nesses support on-site donations often referred to as a
mobile operation. Collection staff travels to the busi-
ness and sets up a mobile collection site to collect blood
from the employees during business hours. This type
of operation is ideal as a win-win partnership where
businesses can support blood donations by allowing
their employees to take time from work to donate with
minimal impact on their daily business operations.
Access to the Internet has provided another venue
for blood facilities to recruit donors. Today donors can
schedule a donation appointment online, update con-
tact information, and even earn points toward thank
you gifts on their blood organization’s web site. An-
other technique that takes advantage of technology
includes sending text messages to donors on their cell
phones to remind them of donation appointments.
Many blood facilities also offer promotional items for
recruiting donors; however, this practice must be care-
fully monitored to ensure that the items are not con-
sidered as a payment for blood donations. The FDA
requires that blood collected from a donor who re-
ceives a monetary incentive or an incentive that can be
converted to cash must be labeled as coming from a
paid donor.4
DONOR REGISTRATION
Allogeneic donors who present may donate whole
blood, platelets, and/or plasma depending on certain
eligibility requirements; however, the registration
process and medical history evaluation are the same
for all allogeneic donors. The donation process begins
with the proper identification of the potential donor to
BOX 1-1
Donor Identification Information
Full name: Last, first (middle name or initial is optional)
Date of birth
Address
Home and/or work telephone number
e-mail address
Sex
Ethnic group
ensure traceability of the collected blood beginning
with the donor through the processing and compo-
nent preparation, to distribution, and final transfusion
of the blood to the recipient. Many collection facilities
require a photograph for identification, although this
is not necessary. FDA regulations require that enough
information is available to accurately relate a blood
component to a donor, and AABB standards require
that a donor’s identity be confirmed and whether a
repeat donor is linked to existing records.5 At some
collection facilities, computer software includes the
incorporation of donor photographs and fingerprints
as methods for verifying donor identity. Traceability is
important in the event that if an adverse reaction oc-
curs from the blood transfusion, it may require notifi-
cation of the donor for further investigation. Donor
verification is also important in identifying donors
whose name is on a temporary or permanent deferral
list. Identification must occur before the components
prepared from that donor’s blood are labeled for
distribution.3,6
A list of information often obtained from the
potential donor on the day of donation is found in
Box 1-1. In general donors must be in good health and
at least 16 years of age or as applicable by state law.5
Donors can donate a unit of whole blood once every 8
weeks or two units of RBCs collected by automation
once every 16 weeks.5,6
UNIFORM DONOR HISTORY
QUESTIONNAIRE
On the day of donation, the eligibility of a donor is de-
termined by a medical history and physical assess-
ment to ensure that the donor is in good health, that
the donation process is safe for the donor, and to iden-
tify risk factors for diseases transmissible by blood
and blood components.7 Many blood centers in the
United States use the AABB Uniform Donor History
Questionnaire (UDHQ), which was developed by a
multiorganizational task force at the request of the
82043_ch01.qxd 11/11/09 5:42 PM Page 3
FDA.8 The goal of the task force was to develop ques-
tions that would increase the comprehension by
donors and by doing so, the accuracy of answering the
questions would increase the safety of the blood sup-
ply. The task force developed four documents that are
meant to be used together.9
• Donor education material is an informational
sheet designed to be read by the donor prior to
completing the questionnaire. The material
provides information about the donation pro-
cess; the importance of answering the questions
truthfully and accurately; risks and conditions
that would defer an individual from donating
blood; defines sexual contact; and explains in-
formation on the human immunodeficiency
virus (HIV) and acquired immunodeficiency
syndrome (AIDS). Figure 1-1 is an example of
the donor education material.
• UDHQ simplifies capture questions on a broad
basis and triggers follow-up questions if an un-
acceptable answer is given. The questions are
also grouped and listed chronologically to help
donors recall information and events that oc-
curred in the past. Figure 1-2 is an example of
the UDHQ.
• Medication deferral list is a list of medications
that may initiate a deferral and includes ratio-
nale for the deferral in language understand-
able to the donor. Figure 1-3 is an example of
the medication list.
• Donor history questionnaire brochure details
how the questionnaire should be administered
and includes a glossary, flow charts, and sug-
gestions for follow-up questions.
The UDHQ can be self-administered by the donor
or be completed as a staff-assisted questionnaire
whereby collection staff orally interviews the donor.
If self-administered, collection staff will review the
donor’s answers asking follow-up questions as neces-
sary to further define a donor’s eligibility. Many blood
centers are implementing automated processes for
both the questionnaire and physical assessment. The
benefit of computer-assisted programs is that data are
captured directly from the donor instead of transcrib-
ing donor information by the interviewer. Removing
the need to transcribe assists in accurate documenta-
tion, which increases the quality and safety of the
donation process.
PHYSICAL ASSESSMENT
Following the medical evaluation, the donor must un-
dergo a physical assessment. The primary purpose of
CHAPTER 1 Blood Collection and Processing 3
TABLE 1-1 Tests for Assessing Donor Eligibility of
Allogeneic Donors
Test Minimum Acceptable Value
Copper sulfate (CuSO4) 1.053 specific gravity
Hemoglobin ⱖ12.5 g/dL
Hematocrit ⱖ38%
Temperature ⱕ37.5°C
Pulse 50᎐100 beats/min without patho-
logic irregularities
⬍50 beats/min if otherwise healthy
athlete
Blood pressure
Systolic ⱕ180 mmHg
Diastolic ⱕ100 mmHg
the physical assessment is to ensure that the donor is
in good health and that the donation process will be
safe for the donor. Table 1-1 lists the tests used to eval-
uate the donor and the ranges for acceptability of allo-
geneic donors. The reader is also referred to the latest
edition of the AABB Standards for Blood Banks and
Transfusion Services for specific requirements for allo-
geneic donor qualification.5 Any exceptions to routine
findings must be approved by the blood bank physi-
cian and may require an individual evaluation. These
should be addressed in the facility’s policies and
procedures.
Hemoglobin/Hematocrit
The hemoglobin concentration or hematocrit must be
determined before donation with a sample of blood
obtained by a finger stick or venipuncture. The pur-
pose of this test is to determine that the donor’s
packed cell volume is acceptable and that the donor is
not anemic. A simple screening method is performed
by determining the minimum acceptable density of a
drop of blood. A sample of whole blood is dropped
into a solution of copper sulfate with a specific gravity
of 1.053. If the drop of blood sinks within 15 seconds,
the donor’s blood volume is equal to or greater than
the specific gravity and is acceptable. If the drop of
blood floats or drops to the bottom of the container
after 15 seconds, another method of determining ac-
ceptability may be used to determine the hemoglobin
or hematocrit. There are several instruments commer-
cially available for determining either the donor’s
hemoglobin or hematocrit. The hemoglobin must be a
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4 UNIT 1 Blood and Blood Components

FIGURE 1-1 Donor education material. (Used with permission of BloodSource, Sacramento, California.)
82043_ch01.qxd 11/11/09 5:42 PM Page 5

CHAPTER 1 Blood Collection and Processing 5

FIGURE 1-2 Uniform donor history questionnaire form. (Used with permission of BloodSource, Sacramento,
California.)
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6 UNIT 1 Blood and Blood Components

FIGURE 1-3 Medication deferral list. (Used with permission of BloodSource, Sacramento, California.)
82043_ch01.qxd 11/11/09 5:42 PM Page 7
minimum of 12.5 g/dL and the hematocrit a mini-
mum of 38% for allogeneic donors.6
Temperature
The donor’s oral temperature should not exceed
37.5°C or 99.5°F.5 Higher temperatures may be an
early indication of a fever due to a cold, flu, or other
infection.
Blood Pressure
The systolic blood pressure should be no higher than
180 mm Hg and the diastolic pressure should be no
higher than 100 mm Hg.5 Prospective donors with
higher readings may have their blood pressure evalu-
ation repeated if it appears that the donor is anxious
or recent activity indicates a possible cause for a high
reading. In such case it may be advisable for the donor
to rest for a few minutes before repeating the blood
pressure evaluation.
Pulse
The prospective donor’s pulse rate should be counted
for a minimum of 15 to 30 seconds and should not re-
veal any pathologic cardiac irregularities. Acceptable
pulse rates should be between 50 and 100 beats/min
although some donors who are athletic or exercise
regularly may present with an acceptable pulse rate
lower than 50 beats/min.5 Such exceptions should be
addressed in each facility’s policies and procedures.
CONFIDENTIAL UNIT EXCLUSION
All donors must be given the opportunity to indicate
confidentially whether their blood is safe for transfu-
sion.10 Some facilities provide a second opportunity to
prevent use of a unit from a high-risk donor through
a process called confidential unit exclusion (CUE).
The CUE may occur during or after the donation pro-
cess, allowing the donor another chance to indicate
whether the unit is suitable for transfusion. One such
method involves giving donors a ballot labeled with
the bar-coded unit number corresponding to the do-
nation. The donor is asked to mark the appropriate
box to determine whether his or her unit is safe to
transfuse. The ballot is deposited into a ballot box
when the donor leaves the phlebotomy area.
Another method is to use a bar-coded CUE sticker
(Fig. 1-4). The donor is asked to apply the appropriate
barcode sticker of “yes” or “no” to either the donor
card or the blood bag. The sticker is read by a barcode
scanner before the processing of the unit is complete.
CHAPTER 1 Blood Collection and Processing 7
Confidential safety check
Instructions
As a final check to assure a safe blood supply, please place one of
these labels in the space indicated on your medical history form.
THIS IS AN IMPORTANT PART OF THE DONATION PROCESS –
CONSIDER YOUR CHOICE CAREFULLY. REGARDLESS OF YOUR
CHOICE, ALL DONATIONS ARE TESTED.
USE DON’T USE
YOU BELIEVE YOUR DONATION IS SAFE
TO GIVE TO A PATIENT
YOUR DONATION TODAY WILL BE
THROWN AWAY.
FIGURE 1-4 Confidential unit exclusion (CUE) sticker.
If the scan indicates the unit is unsuitable for transfu-
sion, it is discarded.
A third method which is used most often is to pro-
vide the donor with instructions to call a toll-free tele-
phone number if the donor believes that their unit
should not be used for any reason. Although the in-
tent is to offer a high-risk donor a way to anony-
mously request that their unit not be used, most often
calls are from donors reporting an illness such as a
cold or flu.
In all cases, a mechanism must be in place to allow
retrieval and disposal of the unit. The donor must be
informed whether testing will be performed and, if so,
that notification will occur with any positive tests.5
The donor should also be told whether a deferral is
associated with the self-exclusion.
CONSENT
Following the medical evaluation and physical assess-
ment, the donor’s consent must be obtained prior to
the donation process. The collection procedure should
be explained in a manner that is understandable to the
donor, including risks of the procedure and any test-
ing performed to reduce the risk of transmission of in-
fectious diseases.5 The donor should also be apprised
that there may be circumstances when infectious dis-
ease testing may not occur. Prior to signing the con-
sent, the donor must have the opportunity to ask
questions and to agree to or refuse consent.
BLOOD COLLECTION
Whole-blood donations remain the primary method
for collecting blood, although advances in technol-
ogy provide increased opportunities for blood cen-
ters to collect specific components. Automation has
82043_ch01.qxd 11/11/09 5:42 PM Page 8
8 UNIT 1 Blood and Blood Components
advanced from collecting just platelets and plasma to
include automated collection of whole blood, which
can be processed into separate RBC and plasma com-
ponents during the collection process. Alternatively,
the equivalent of two units of packed RBCs can be col-
lected from one donor. The reader is directed to Chap-
ter 2 to learn more about hemapheresis or automated
procedures.
AABB standard states that a maximum of 10.5 mL
of whole blood can be collected per kilogram of donor
weight, including samples and the blood collection
container.5 Allogeneic donors must weigh a minimum
of 110 lb or 50 kg; therefore, a maximum volume of
525 mL of whole blood can be collected from this min-
imum weight.
Blood is collected in a special container approved
by the FDA. Blood bags must be sterile, pyrogen-free,
and identified by a lot number.6 In addition blood
bags must contain enough anticoagulant proportional
to the amount of blood collected. Most blood centers
collect blood in either a 450-mL or 500-mL blood bag,
which contains 63 mL of anticoagulant. Depending on
the type of anticoagulant, additive solutions may be
added to red cells to extend their expiry date. The type
of anticoagulant or additive chosen determines the
shelf life of the RBCs after collection as listed in
Table 1-2. The reader is directed to Chapter 3 for more
information on component preparation. Blood bags
are also available in a variety of configurations. Most
commonly, a blood bag set consists of a primary bag
that contains the anticoagulant with one or more satel-
lite bags attached to the primary bag as a closed
system which complements the various blood compo-
nents that can be made from the unit of whole blood.
Labeling and Identification
Proper labeling of the unit is essential for identifying
it back to the individual donor from whom the blood
was collected. A unique identification number is as-
signed to the unit at the time of collection and will
follow the unit and its components throughout the
processing and distribution of its components for
transfusion.
TABLE 1-2 Anticoagulants in Whole-blood
Containers
Anticoagulant Shelf Life (Days)
Citrate phosphate dextrose (CPD) 21
Citrate phosphate dextrose adenine (CPDA-1) 35
Adenine-saline 42
1 2
5100
00
W0000 08 123456 X
O
Accurate Blood Center
Anywhere, USA
FDA Registration Number 123456
Properly Identify Intended Recipient
See Circular of Information for indications,
contraindications, cautions and methods of Rh POSITIVE
infusion.
This product may transmit infectious agents
Rx Only
VOLUNTEER DONOR
4
3 Expiration
Date
E0291V00 0080312359
RED BLOOD CELLS 31 JAN 2008
ADENINE-SALINE (AS-1) ADDED
5
From 450 mL CPD Whole Blood
Store at 1 to 6 C N0008
US License Number 123
Negative for antibodies to CMV
1 Donation Identification Number
2 ABO/Rh Groups
3 Product Code
4 Expiration Date and Time
5 Special Testing
FIGURE 1-5 ISBT 128 base label. (Used with permis-
sion of ICCBBA, San Bernardino, California.)
Effective May 1, 2008, the United States Industry
Consensus Standard for the Uniform Labeling of
Blood and Blood Components using ISBT 128 (Inter-
national Society of Blood Transfusion) replaced the
1985 FDA Uniform Labeling Guidelines that were
based on the Codabar format.11 The advantages of
ISBT 128 is a labeling scheme that ensures a unique
identification number and includes a center prefix that
identifies the collecting blood center. In addition prod-
uct codes are standardized that can be recognized in-
ternationally. Another advantage is the check digits in
the barcode that can be used for detecting scanning er-
rors, which will increase the safety of identifying the
correct unit to the intended recipient.11 Figure 1-5 is an
example of a base ISBT label. The label is made up of
four quadrants with the upper left containing the
unique barcode identification number of the unit and
information about the collecting facility. The upper
right quadrant holds the blood type, the lower left
quadrant displays the product code and the lower
right quadrant displays the expiration date and any
special attributes such as CMV antibody status.12
Selection of Vein and Arm Preparation
Prior to the collection of blood, both arms of the donor
are inspected to select a suitable vein for phlebotomy
as well as to ensure the venipuncture site is free of
signs of infection or evidence suggestive of “track”
marks or sclerotic veins that may indicate intravenous
drug use.6 If the donor’s arms are questionable, the
donor should be deferred from donating.