EDITORIAL
A healthy donor or unsuspecting patient
B
lood donors acknowledge feeling healthy and
well on the day of donation. With each dona-
tion, they undergo medical screening that
includes vital signs, medical history, and labo-
ratory tests to ensure their health and to qualify the dona-
tion for distribution. Some donors are disqualified for
failing to meet criteria for physical findings, medical
history, or laboratory processing of components and/or
sample testing. The blood center physician has the duty to
inform the apparently healthy donor of the potential of
being “ill” and that some level of medical attention may be
warranted.
The majority of deferrals occur before donation at the
blood collection site. Donors are informed of the reason
for their disqualification, provided with information, and
advised to seek evaluation by a health care provider when
necessary. The most common example is the donor with
low hemoglobin (Hb); less common is the discovery of
irregular pulse or high blood pressure of which the donor
was unaware.
Successful donations must undergo testing to deter-
mine the ABO group and Rh type, to detect unexpected
antibodies to red blood cell antigens, and to prevent
disease transmission. Selected donations may undergo
additional tests to qualify components for specific use, for
example, detection of cytomegalovirus (CMV) antibody,
HLA antibody, HbS, parvovirus B19, and bacteria. Existing
standards and regulations mandate donor notification of
medically significant abnormalities detected during the
predonation evaluation or as a result of laboratory testing
or recipient follow-up.1,2 In addition, standards require
that appropriate education, counseling, and referrals be
offered.
In this issue of TRANSFUSION, Rottenberg and col-
leagues report an increased risk of cancer, especially
hematologic malignancies, in blood donors with positive
direct antiglobulin tests (DATs).3 They report that DAT-
positive donors are notified by letter and referred to their
family physician for further medical counseling and
follow-up. They do not report whether DAT-positive
donors are deferred permanently or for a defined time
period. They raise the question of informing donors or
their physicians regarding the possible presence of undi-
agnosed autoimmune disease or occult malignancies,
especially lymphoproliferative disorders.
Most blood centers notify donors of deferral by letter
including information on the reason for deferral, the
TRANSFUSION 2009;49:818-820.
818 TRANSFUSION Volume 49, May 2009
infectious agent, the disease, what to do, and what not to
do. The letter should have a call-back number for donors
with questions. Blood centers employ counselors trained
to respond to deferred donor questions.
The information donor centers transmit is complex
and issues related to donor deferral, notification, counsel-
ing, and referral are diverse and challenging.4-6 Even
though one reassures a donor that the false-positive test
result has no health significance, the accompanying
message that the donor may not donate blood in the
future is troublesome. Kleinman and coworkers7 report on
difficulty of understanding, contacting the blood center
for information, discussion with a physician or health
care provider, confusion, and emotional upset in donors
informed of confirmed negative results. Busch8 comments
on the “troubling” situation in donors with indeterminate
classification, since the counseling message to these
donors must include the possibility that they may have
very early or resolved infections or may be infected with
an immunologic variant virus. He adds that donors with
indeterminate confirmatory test results may undergo
extensive follow-up testing, often at personal expense,
and suffer anxiety or serious psychosocial damage.
Donors with positive test results may have infectious
(virus, bacteria, or parasite) or noninfectious conditions
(positive DAT, positive HLA antibody, HbS). Each category
has its own issues when it comes to donor notification,
counseling, and referrals. In the authors’ institution,
donors infected with human T-lymphotropic virus, hepa-
titis B virus, hepatitis C virus, and Trypanosoma cruzi are
permanently deferred, notified, and referred to health
care providers for management and follow-up. Donors
infected with Treponema pallidum or West Nile virus are
temporarily deferred and referred to health care providers
for management and follow-up. Since donors with CMV
antibody or parvovirus B19 are not deferred, they are not
notified of their results. Based on the isolated organism,
practice varies in managing donors who are found to have
positive bacterial culture during quality control testing
of their platelet (PLT) donations. In the noninfectious
categories, donors with HLA antibody are notified
and diverted from donating high-plasma-volume
components; those with positive DAT are temporarily
deferred, notified, and referred to a health care provider
for evaluation; and those who are identified with HbS are
notified only if deferred due to leukofiltration failure on
multiple occasions.
What is the role of the blood center and its physician
in donor notification, counseling, and referral? What is the

role of the donor’s health care provider? What form of
communication should occur between the blood center
physician and the donor’s health care provider? Most indi-
viduals donate blood thinking they are perfectly healthy
and wanting to support a worthy cause. Receiving health
information from the donor center can shatter the donor’s
belief about his/her good health and it almost always
means that the donor will have unwanted and unexpected
expense. Denial is to be expected in some cases and
receipt of the information almost always raises questions.
In sum, it is difficult to provide complex information
directly to the donor, so the donor center physician must
apply the necessary effort to achieve understanding. A
level of personal interaction with the donor is necessary to
provide information that stimulates the donor to seek
evaluation and the donor’s physician to do the appropri-
ate management, but not to provoke irrational fear.
Notifying by letter is probably acceptable when there
is a good chance that the message and the required
actions will be understood. Human immunodeficiency
virus–infected donors are notified in person by a blood
center physician. It is our experience that notification for
most conditions (save possibly T. cruzi) by letter is quite
effective. A reasonable approach for bacterial screening
data might be to notify donors of skin contaminants via
letter (if at all) and to have a physician notify of patho-
genic organisms by telephone or in person. If the donor
calls the donor center, counseling is provided; the donor
center physician informs the donor in a fashion that sup-
ports further evaluation if appropriate. Only the donor’s
physician who knows the donor’s health and history can
properly put the information in context. If the donor does
not call the blood center but goes directly to his/her phy-
sician, there are different barriers. The donor’s physician
may have doubts about the information because of its
source, not being aware of donor center practices, the sig-
nificance of findings and because the doctor believes, as
did the donor, in the donor’s good health. A common
example is that the screening test used by blood centers
for anti-hepatitis B core antigen (HBc) detects both the
immunoglobulin (Ig)G and IgM components. The donor’s
physician typically orders IgM anti-HBc to exclude
acute infection. This testing is often negative and the
donor is told that the blood center result is in “error.” As a
result, the donor often returns to the center requesting
compensation for the unnecessary testing prompted by
this error.
If the United States had a health care system, the
blood center would tell the donor’s physician the reason
for providing the information with references to support
the need for evaluation. Unfortunately communication
with the donor’s physician can only happen with the
donor’s permission. The donor center physician must
provide information to the donor and often must negoti-
ate access to the donor’s physician.
EDITORIAL
Over the past 25 years, blood centers implemented
screening tests for identified transfusion-transmitted
agents. In many instances, the implementation of blood
donor screening tests preceded the availability of public
health guidelines for the practicing physician for manag-
ing individuals identified during the blood donation
process as infected.9-12 Blood donor screening programs
identify donors infected with varieties of “uncommon”
infectious agents who are often referred for evaluation and
management by community health care providers who
are not well prepared to manage such persons. In these
circumstances the donor center physician may have to
ensure that the donor’s physician becomes prepared or is
willing to refer the donor to someone who is prepared to
evaluate the circumstances.
Blood center physicians should review and evaluate
abnormal test results and set the threshold for medical
referral based on current knowledge. One should not
minimize the significance of an abnormality because the
donor population is healthy. The donor center has the
duty to provide the information to the donor and eventu-
ally to the donor’s physician so the donor’s physician can
determine if an evaluation is warranted.
It is only within the past 6 years that blood centers
had routine bacterial culture results on PLT donors.
Haimowitz and coworkers13,14 showed that PLT donors
whose donated PLTs were contaminated with pathogenic
bacteria have some treatable pathology. Blood center
physician interviews revealed 10 untreated or possibly
incompletely treated infections that were undisclosed or
unknown at the time of donation in 57 donors whose
donated PLTs were found to be truly contaminated with a
known pathogen.13 Of 13 apheresis PLT donors with Stre-
ptococcus bovis–positive cultures, 6 had newly diagnosed
polyps (n = 4) or cancer (n = 2) after the S. bovis was
detected; 2 were cleared of associated disease by their per-
sonal physician, which included a colonoscopy near the
time of donation; and 5 had not been completely evalu-
ated at the time of publication.14
The association of pathology with a positive DAT is
less strong. Positive DAT is frequently found in the normal
population. The majority are false positive or due to harm-
less autoantibodies. The association with cancer, espe-
cially hematologic malignancies needs confirmation. Our
policy is to defer a donor with positive DAT for 6 months.
Our message to the donor is that a positive DAT is
observed in healthy donors where a cause is often not
identified. We include a statement that a positive DAT may
be associated with use of certain medications, viral infec-
tions, autoimmune diseases, or hemolytic anemia. We
encourage the donor to share the information with a per-
sonal physician for evaluation. At this time, we would
not include the observation by Rottenberg and colleagues
in our notification letter, but given the opportunity,
would share its findings—in context—with the donor’s
Volume 49, May 2009 TRANSFUSION 819
EDITORIAL
physician. This program is consistent with the assessment
by Rottenberg and colleagues that further studies are nec-
essary to confirm this association3 and with our approach;
that is, a level of personal interaction with the donor is
necessary to provide information that stimulates the
donor to seek evaluation and the donor’s physician to do
the appropriate management, but not to stimulate prema-
ture and unnecessary anxiety.
The process of informing the donor usually creates an
issue that only the donor and his/her physician can
resolve. That issue is balancing the expense of further
medical evaluation against the value of the evaluation in
maintaining the donor’s good health. The donor center
physician should not withhold information from the
donor fearing that the donor’s physician will not be able to
resolve this issue with the donor. Disqualified donors
should be informed in simple terms and in a compassion-
ate manner. Donors with ambiguous results should be
evaluated until a clear message can be delivered to them.
Donors needing medical attention should receive appro-
priate referral for further evaluation and care. The donor’s
physician should have access to the donor center physi-
cian to discuss the donor’s medical findings. Literature
and guidance documents should be made available to the
health care provider. Research should guide the enhance-
ment of the donor notification process.15,16
CONFLICT OF INTEREST
The authors declare no conflict of interest.
Hany Kamel, MD
Peter Tomasulo, MD
e-mai: ptomasulo@bloodsystems.org
Blood Systems, Inc.
Scottsdale, AZ
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