Download How do I investigate septic transfusion reactions and blood donors

HOW DO I . . .?
How do I investigate septic transfusion reactions and blood
donors with culture-positive platelet donations?
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1662..1668
Anne F. Eder and Mindy Goldman
I
n the early 1990s, bacterial contamination of
blood components was recognized as the most
common cause of transfusion-transmitted infection, accounting for between 14 and 24% of transfusion associated fatalities reported to the US Food and
Drug Administration and various hemovigilance systems.1
Because platelets (PLTs) are stored at room temperature,
they provide a hospitable environment for the growth of
many bacterial organisms and are most often involved in
septic transfusion reactions. Many measures have been
taken to prevent bacterial contamination, including verifying the donors’ temperature and questioning them
about infection, optimizing skin disinfection before phlebotomy, and diverting the initial aliquot of blood collected
during the procedure.1 Blood centers have also introduced
methods to detect contamination, such as culturing PLT
donations and visually inspecting components before the
transfusion. Indeed, since the 22nd edition in 2003, the
AABB Standards for blood banks and transfusion services
state that the blood bank and transfusion service shall
have methods to limit and detect bacterial contamination
in all PLT components.2,3
These measures have reduced but have not completely eliminated the risk of septic transfusion reactions.
Prompt investigation of suspected septic transfusion reactions is essential not only to provide appropriate care for
the affected patient, but also to prevent transfusion of
other bacterially contaminated cocomponents from the
same donation. For whole blood–derived PLTs, associated
red blood cell (RBC) units and occasionally frozen plasma
units have been found to be contaminated as well
as the PLT component from a donor.4,5 For apheresis
From the American Red Cross, Rockville, Maryland; and Canadian Blood Services, Ottawa, Ontario, Canada.
Address reprint requests to: Anne Eder, MD, PhD, American
Red Cross, Biomedical Services, National Headquarters, Medical
Office, Jerome H. Holland Laboratory, 15601 Crabbs Branch
Way, Rockville, MD 20855; e-mail: [email protected].
Received for publication November 15, 2010; revision
received January 4, 2011, and accepted January 10, 2011.
doi: 10.1111/j.1537-2995.2011.03083.x
TRANSFUSION 2011;51:1662-1668.
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Volume 51, August 2011
units, double and triple PLT collections are increasingly
common and there have been several reports of contamination of all apheresis components from the same donation.6,7 In addition, the involved donors, and steps in the
component preparation process, are evaluated to assess
the possible source of bacterial contamination. Although
the vast majority of bacterial isolates implicated in septic
transfusion reactions are organisms that are part of
normal skin flora, in rare cases, bacteria isolated in the
context of a septic transfusion reaction may have implications relevant to the donors’ health. Moreover, blood
centers evaluate the information to assess these donors’
continued eligibility to donate blood for transfusion to
others. As with other major adverse transfusion reactions, the identification, investigation, and reporting of
these reactions to the hemovigilance scheme are important to evaluate the extent of the problem and the efficacy
of preventive measures that may have been introduced.
HOW DO I INVESTIGATE SUSPECTED
TRANSFUSION-RELATED SEPSIS?
Especially since the adoption of preventive measures,
transfusion-related septic reactions are relatively rare,
occurring at a frequency of less than 1 in 15,000 to 1 in
100,000 transfusions.2,5-8 Therefore, clinical and laboratory
staff will not necessarily have direct experience or expertise in recognizing or investigating these reactions. US and
Canadian surveys of blood bank personnel and hospital
microbiologists demonstrate that many hospitals do not
have written protocols addressing actions to be taken at
the bedside and in the laboratory for suspected bacterial
sepsis.9,10 As a first key step in dealing with these reactions,
the hospital transfusion committee should develop a
written protocol outlining clinical triggers for investigation of suspected contamination, and subsequent actions
to be taken at the bedside and in the laboratory. Published
guidelines may assist in development of a protocol
adapted for local use.11-13
CLINICAL TRIGGERS FOR INVESTIGATION
OF SUSPECTED CONTAMINATION
The vast majority of septic transfusion reactions become
symptomatic during the transfusion or within 4 hours
INVESTIGATION OF BACTERIALLY CONTAMINATED PLTs
afterward. Most patients present with fever, which may be
accompanied by rigors, tachycardia, dyspnea, and nausea
or vomiting. Infusion of a unit containing a Gram-negative
organism, with high levels of endotoxin, may result in
shock and disseminated intravascular coagulation. A high
index of suspicion for sepsis may be necessary in situations where the patient is in the operating room or is
febrile or already on antipyretics. Fever after transfusion
may be defined in various ways, such as an increase of at
least 1°C compared to the pretransfusion value or exceeding a value of 38 or 39°C. Clinical judgment is required in
taking into consideration the patient’s condition before
the transfusion.
ACTIONS TAKEN AT THE BEDSIDE
If sepsis is suspected, the transfusion should be stopped
immediately. If possible, the open port should be covered
with a cap or the tubing should be clamped and the blood
component bag placed in a sealed plastic bag to contain
leakage, to decrease the risk of posttransfusion contamination. It is important to attempt to minimize contamination since retrograde contamination of the unit has been
reported.14 In these cases, patients who were already
septicemic or had colonization of an indwelling catheter
line had retrograde dissemination of bacteria into the
remaining blood component. All bags of transfusions
given within the 4 hours preceding the onset of symptoms
should be promptly sent to the laboratory for testing. The
bag and any remaining component should be inspected to
detect any visible anomaly, since small punctures or leaky
seals have been identified as sources of contamination of
units, and some contaminated units may have an abnormal appearance.15,16
At least one set of blood cultures should be obtained
from the patient before administering antibiotic therapy.
Clinical judgment is required to determine if blood cultures are necessary for patients already on antibiotics.
Blood cultures should be performed for patients exhibiting signs and symptoms of severe sepsis, such as hypotension and tachycardia, and those with evidence of ongoing
infection, such as persistent fever.
ACTIONS TAKEN IN THE LABORATORY
The blood supplier should be notified immediately in
cases where bacterial contamination is very likely, since
cocomponents from the same donation may also be contaminated. At Canadian Blood Services and the American
Red Cross, immediate action is taken when we receive
notification of a potential septic transfusion reaction.
Any cocomponents from the same donation will usually
be removed from inventory and sent for culture, if the
suspicion of sepsis is high. If the probability of sepsis is
low, and information is incomplete, these products may
be placed in quarantine pending further information. If
cocomponents have already been distributed to hospitals, we would advise them to assess recipients for possible posttransfusion sepsis. If components have not yet
been transfused, we would advise hospitals to either
destroy them, in a high probability case of sepsis, or
quarantine them pending further investigation. Alternatively, hospitals may return these products to the blood
center for culture, or perform a culture themselves,
before destroying the unit. The status of the inventory
and type of cocomponent will also influence the decision
whether to simply discard cocomponents or quarantine
them. For example, if a hospital informs us that a patient
who has received a whole blood–derived pool of 5 PLT
units has had a 1°C elevation in temperature with moderate chills, we might quarantine the 5 RBC and freshfrozen plasma units that remain in our inventory,
pending further investigation of the patient and the PLT
pool.
LABORATORY INVESTIGATION OF THE
BLOOD COMPONENTS
Aseptic technique should be used when sampling remaining blood components. If no blood is remaining in the bag,
10 to 20 mL of trypticase soy broth, other culture broth, or
sterile saline should be aseptically injected into the bag.
After the bag is mixed, the broth or saline is reaspirated
and used for inoculation into culture bottles. Segments
are rarely if ever a useful source of sample for bacterial
culture. Since the initial inoculum of bacteria is usually
very low, and the segments contain a small volume of
blood, they are unlikely to become contaminated. Indeed,
normal appearance of segments compared to a darkened
appearance of a RBC unit has alerted some observant
blood bankers to the presence of contamination of
16
RBC units. Not only are segments unlikely to contain any
bacteria present in the blood component and usually
yield a misleading (i.e., false-negative) culture result in an
investigation, it is also difficult to obtain a sample from a
segment, leading to a high risk of laboratory contamination and false-positive result. The remaining blood components should be inoculated into a set of aerobic and
anaerobic blood culture bottles, according to the manufacturer’s instructions. Bottles should be incubated for 5
to 7 days at 35 to 36°C. According to the Clinical Microbiology Procedures Handbook of the American Society for
Microbiology, a direct slide should also be prepared from
all bags for Gram or acridine orange staining and microscopic examination.12 In our experience, this is especially
useful in a severe reaction since it may guide initial choice
of antibiotic therapy.6 If bacteria are seen on direct examination, or if positive blood culture occurs, the laboratory
should perform cultures on solid media according to its
standard procedures. If positive blood culture results are
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EDER AND GOLDMAN
obtained on the recipient, bacteria should similarly be
identified according to standard procedures. If the same
bacterium is isolated from both the patient and the blood
component, the laboratory should attempt to confirm the
identity of the strains. This is especially important if
a common skin contaminant such as Staphylococcus
epidermidis is isolated. Identity can be confirmed by
methods such as antibiotic susceptibility, serotyping, or
molecular typing by pulse-field gel electrophoresis.
Strains may be sent out to a reference laboratory for more
specialized analysis.
The blood supplier should be informed of the
final results of the investigation such as cultures, isolate
identification, and other laboratory results. Proper investigation of these cases is important not only for treatment of the individual patient, but also for classification
of the adverse transfusion reaction in the hemovigilance
scheme in use in the country. Unfortunately, if an inadequate investigation has been performed, it is difficult
to resolve the cause of the patient’s symptoms and
determine whether the blood component is definitively implicated as the source. Appropriate counseling and management of involved donors also depend
on a thorough investigation of the septic transfusion
reaction.
INVESTIGATION OF BLOOD DONORS WITH
CULTURE-POSITIVE PLT DONATIONS
Bacterial contamination of blood components can occur
during collection or processing, but may rarely identify
chronic, asymptomatic bacteremia in a healthy blood
donor.2 Consequently, blood centers should investigate
blood donors who have been implicated in a septic transfusion reaction as well as those who are found through
routine quality control (QC) testing to have bacterially
contaminated PLT donations. Blood centers should not
only consider whether the culture result has significance
to the donor’s health but also need to assess the likelihood
of recurrent bacterial contamination in subsequent donations and judge whether the donor should be deferred
from future blood donation.
DONOR HEALTH AND SIGNIFICANCE OF
CULTURE RESULTS
Blood centers in the United States and Canada question
prospective blood donors about their general health and
take their temperature, which excludes donors with fever
as well as many donors who have infections that may be
transmitted through blood transfusion. However, the
screening process cannot prevent donation by healthy
individuals who have episodic bacteremia, by asymptomatic individuals with early or resolving bacterial infections,
or by individuals with a chronic, low-level and asymptomatic bacteremia.17 The vast majority of positive culture
results in both septic transfusion reactions and routine QC
testing are normal skin flora (e.g., Staphylococcus spp.,
Streptococcus spp.), suggesting contamination at the time
of phlebotomy.7 Other bacterial isolates found to contaminate PLT donations are less likely to colonize healthy skin
and have been associated with recent illness, underlying
medical conditions, or unusual circumstances such as
exposure to exotic pets or feral cats (Table 1).17-24 Medical
evaluation of positive culture results associated with a
blood donation is further complicated by the diversity of
bacterial species that normally colonize healthy skin and
the possibility that atypical bacteria species may temporarily reside on the skin (Table 2).25-28 Conversely, some
TABLE 1. Asymptomatic donor bacteremia implicated as source of contaminated PLTs
Bacterial isolate
S. bovis
S. agalactiae (Group B streptococcus)
S. aureus
Viridans streptococci
S. aureus
Salmonella cholerae-suis
Salmonella heidelberg
Salmonella enterica
Pasteurella multocida
Donor investigation
Adenocarcinoma of the colon
Bacterial endocarditis
Tooth extraction; dental procedures
Subclinical osteomyelitis
Salmonella enteritis
Pet snake owner
Feral cat bites/exposure
Reference(s)
Haimowitz et al.18
Stevens et al.19
Blajchman et al.20
Goldman and Blajchman17
Braine et al.21
Rhame et al.22
Heal et al.23
Jafari et al.8
Bryant et al.24
TABLE 2. Unusual skin contaminates in donations implicated in septic PLT transfusion reactions
Bacterial isolate
Clostridium perfringens
Enterobacter cloacae
Enterococci; staphylococci
Morganella morganii
1664 TRANSFUSION
Donor investigation
Isolate was cultured from implicated donors’ venipuncture site; authors commented
that “the donor had two young children and frequently changed nappies”
Implicated donor had scarred, “dimpled” venipuncture site
Isolate was cultured from implicated donor’s stool; donor was asymptomatic
Volume 51, August 2011
Reference
McDonald et al.25
Blajchman et al.20
Anderson et al.26
Golubić-Ćepulić et al.27
INVESTIGATION OF BACTERIALLY CONTAMINATED PLTs
bacterial species that are typically found on normal skin
may also represent infection present in other organ
systems.20
Initial assessment should include questioning
donors about recent illness in the weeks before and
after the involved donation, unexplained symptoms that
suggest occult infection, antibiotic usage, dental problems, and possibly exposure to individuals with contagious diseases. Knowledge of bacterial epidemiology is
necessary and consultation with an infectious disease
specialist may be helpful for more targeted healthy history questioning and review of systems when potentially pathogenic organisms are identified in donations.
Medical assessment of the donor may reveal postdonation
information about resolving or recent infections or periodontal disease or dental conditions that may be associated with transient bacteremia. In other cases, notification
from the blood bank is the first indication that the donor
may have an undiagnosed medical condition that requires
further medical assessment and treatment.
Between March 1, 2004, and September 30, 2008, the
American Red Cross evaluated 402 apheresis PLT donations (0.02% total collections) found to have confirmedpositive QC bacterial cultures.29 Skin contamination was
the likely source in 288 (72%) and possible bacteremia in
114 (28%) of the cases. A relatively common finding with
potential clinical significance was Streptococcus bovis
group, which has been associated with gastrointestinal
neoplasia (e.g., colonic polyps, colon cancer), extracolonic
malignancies, hepatobiliary disease, endocarditis, meningitis, and diabetes mellitus.30 Among the 14 apheresis PLT
donations with S. bovis or S. infantarius in the American
Red Cross during the study period, four donors were
found to have colon cancer, and four donors had benign
colon polyps.29 No underlying medical condition was
identified in two donors, whose medical evaluation
included a colonoscopy performed near the time of the
donation, and no additional information became available after notification of the remaining four donors.31 In a
similar case report, Stevens and colleagues19 identified
Streptococcus agalactiae (Group B streptococcus) in an
asymptomatic donor implicated in a septic PLT transfusion reaction, who was found to have Dukes Stage B
colonic adenocarcinoma. Individuals with S. bovis group
or other enteric organisms identified in donated blood
components should be considered at higher risk for gastrointestinal pathology than the general population.
Notably, the affected donors in these cases were asymptomatic and had negative repeat blood and urine cultures,
but were found either through colonoscopy or by the presence of fecal occult blood to have colonic adenocarcinoma. Consequently, notification and counseling of these
donors should trigger a comprehensive medical evaluation and appropriate cancer screening and monitoring, as
medically indicated.
In contrast, the vast majority of suspected skin contaminants (e.g., coagulase-negative Staphylococcus) rarely
necessitate further referral for medical evaluation unless
the donor reports recent symptoms or relevant medical
history. The American Red Cross identified Abiotrophia sp.
(nutritionally variant streptococci) in a plateletpheresis
donation by a 50-year-old man.31 Upon questioning, he
recalled recent night fevers that he had attributed to
stress. Further medical evaluation led to a diagnosis of
bacterial endocarditis requiring antibiotic treatment.31
Published case reports have also identified Staphylococcus
aureus in association with endocarditis in blood donors.20
Often, however, the medical evaluation of possible
pathogenic organisms does not identify recent illness,
medical history, or any cause for concern about the
donor’s underlying health but instead may represent
more innocuous circumstances or benign conditions. For
example, transient bacteremia may occur after dental
manipulation such as tooth extraction, the use of oral irrigation devices, and even normal teeth brushing or bowel
movements.17,32,33
Typically, the organisms isolated after dental procedures are viridans streptococci that colonize normal oral
mucosa (e.g., S. mitis, S. mutans, S. oralis, S. sanguinis).34 In
addition, S. mutans is a common etiologic agent of dental
caries. In the American Red Cross’ experience, 13% of the
confirmed-positive QC culture results obtained on apheresis PLT donations were viridans group streptococci or
other a-hemolytic Streptococcus spp.7 Although an isolated finding of viridans streptococci or bacterial isolate
that most likely reflects skin contamination is usually
not a cause for concern, donors who have confirmedpositive culture results with the same type of bacteria on
two occasions should be referred for further medical
evaluation. Viridans streptococci are the most common
cause of subacute bacterial endocarditis particularly
in individuals with damaged heart valves. The blood
center should provide the donor and their physician
with information about the bacterial isolate and possible
disease associations and should emphasize the need
for a thorough clinical history and physical examination
and should suggest further evaluation, such as dental
examination or cardiac evaluation, as appropriate.
The experience with performing bacterial cultures
on individuals who present for blood donation has
also yielded some unexpected results with organisms
presumed to have public health significance. Listeria
monocytogenes is a Gram-positive bacillus that can cause
serious sporadic and epidemic food-borne disease. The
American Red Cross identified L. monocytogenes in five
apheresis PLT donations by different individuals during a
53-month period and reported the finding to state health
departments, but none of the five donors had any recent
history of illness and remained healthy after the donation.
In none of the cases was a contaminated food source
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EDER AND GOLDMAN
identified; rather, asymptomatic bacteremia was suspected even though such carriage was considered an
unusual possibility for Listeria isolates.35 Perhaps it is not
surprising that new epidemiologic information has
emerged from routinely performing bacterial cultures on
apheresis PLT donations by asymptomatic, afebrile
individuals, as opposed to the usual diagnostic setting
for performing bacterial cultures when infection is
suspected in patients.
EVALUATION OF FUTURE ELIGIBILITY OF
DONORS WITH BACTERIALLY
CONTAMINATED DONATIONS
After completing the investigation of a bacterially contaminated blood donation, the blood center physician
must also evaluate whether the involved donor should
be allowed to continue to donate blood. The decision to
temporarily or permanently defer a donor is based on
medical judgment, but should consider whether a thorough medical evaluation excluded significant underlying
disease, whether a source of bacteria was identified and
successfully treated, or whether recurrence is possible
with subsequent donations.
To support decision making about donor eligibility
in this context, the American Red Cross evaluated the likelihood of recurrent bacterial contamination of apheresis
PLT donations from donors with confirmed-positive
bacterial cultures.36 Apheresis PLT donors with likely skin
contaminants or possible bacteremia who subsequently
returned to donate during a 53-month period were evaluated separately. A cohort of 212 donors had confirmedpositive donations with likely skin flora and returned
to donate a total of 4066 apheresis PLT donations. Two
donors had a second confirmed-positive donation with a
possible skin organism (0.05% of donations). The rate of
contamination with skin organisms among return donations by individuals with a prior positive result was not
significantly different from the initial rate of contamination (0.01% vs. 0.05%; odds ratio [OR], 0.29; 95% confidence interval [CI], 0.072-1.17). Consequently, donor
deferral is not warranted after two confirmed-positive
culture results with organisms that are most likely skin
commensal bacteria.
In contrast, donors found to have apheresis PLT donations contaminated with bacterial species that suggested
possible bacteremia were more likely to have a second
contaminated donation than was expected to occur by
chance.36 Three donors of the 69 (4%) in this group who
returned to donate had a second confirmed-positive donation with the same or another bacteria isolate that likely
reflected bacteremia. This rate was significantly higher
than the rate of possible bacteremia among presenting
donors (0.05%; OR, 88.1; 95% CI, 27.3-284.5), and the rate of
contamination in repeat donations among this cohort was
1666 TRANSFUSION
Volume 51, August 2011
much higher than predicted to occur by chance even
though each donor had intervening, culture-negative
donations (range, 2-28). One of the donors found to
have contaminated donations with enteric organisms on
two separate occasions (S. bovis/infantarius; Enterococcus
faecium/Streptococcus alactolyticus/Enterococcus gallinarum) had a remote history of colon cancer and had undergone total colectomy. He had been treated for infection
shortly after the second donation and has now been indefinitely deferred from blood donation because he likely
poses a recurrent risk of contaminated donations.
Notably, however, there have been no septic transfusion reactions to apheresis PLT components that have
been linked to donors with a prior confirmed-positive
bacterial culture result in the American Red Cross. Still,
the authors believe that it is prudent to defer donors with
a second positive result for the same or different organism
that could reflect potentially significant bacteremia (e.g.,
S. bovis group; enteric organisms, viridans group streptococci). This recommendation is based on the authors’
experience that the first occurrence of an enteric isolate
only rarely identifies a significant underlying medical condition and does not warrant an automatic indefinite deferral, but a second occurrence in the same donor is unlikely
to occur by chance and may indicate a higher risk of recurrent contaminated donations. Any decision to reinstate
donors who have had two confirmed-positive bacterially
contaminated donations with isolates that suggest potential bacteremia should be carefully considered and may
not be advisable.
In very rare circumstances, a donor who has been
implicated in a septic transfusion reaction has been traced
to septic reactions in other patients. Rhame and colleagues22 described seven cases of Salmonella choleraesuis septicemia to contaminated PLTs from a donor who
had chronic osteomyelitis and low-level bacteremia,
before the introduction of routine QC bacterial testing.
In another case reported to the American Red Cross, a
QC culture-negative plateletpheresis donation that was
divided into three PLT components and transfused to
three different patients on Day 4 of storage caused three
nearly simultaneous septic reactions, attributed to
coagulase-negative Staphylococcus contamination.7 The
donor of the implicated donation was healthy and asymptomatic on the day of donation, but reported a remote
history of bacterial endocarditis. A previous donation
from the same individual several years before implementation of routine QC culture of apheresis PLTs had also
been involved in a septic transfusion reaction from
coagulase-negative Staphylococcus. In the intervening 5
years, the individual donated apheresis PLTs on 63 occasions without a report to the blood center of recipient
reactions or any positive QC culture result. The donor has
now been indefinitely deferred from blood donation to the
American Red Cross, as a precautionary measure. Blood
INVESTIGATION OF BACTERIALLY CONTAMINATED PLTs
centers should have a mechanism to identify donors
involved in septic transfusion reactions, even though
deferral may not be warranted for the first occurrence, to
conduct surveillance to identify subsequent positive QC
culture results or their possible involvement in other
septic cases.
CONFLICT OF INTEREST
The authors declare that they have no conflicts of interest
relevant to the manuscript submitted to TRANSFUSION.
REFERENCES
1. AABB Association. Bulletin #05-02. Guidance on manage-
CONCLUSION
A variety of measures have been implemented to prevent
and detect bacterial contamination of PLTs. These measures have reduced but not eliminated the risk of septic
transfusion reactions. Hospitals therefore should have a
written protocol outlining clinical triggers for investigation
of a suspected septic transfusion reaction and subsequent
actions to be taken at the bedside and in the laboratory.
Actions should include timely reporting of reactions to the
blood supplier and the hemovigilance scheme.
A positive bacterial culture after routine PLT donation
may be the first sign of an occult infection, but requires
case-by-case medical evaluation to determine the possible significance to the donors’ health. Because of the
known association of S. bovis group with gastrointestinal
malignancy and other conditions, blood donors with
culture-positive donations should be counseled and
referred for colon cancer screening, in accordance with
published public health recommendations. They are likely
at even higher risk of colonic malignancy than the general
population. Other significant associations with certain
bacterial isolates should be considered in the medical
investigation. Finally, bacterial screening of apheresis PLT
donors has provided a unique opportunity for a secondary
public health benefit. Donor centers investigating bacterial cultures and recipient reactions have recommended
medical referral for donors with possible asymptomatic
bacteremia, which in rare cases has led to early identification of serious medical conditions, including adenocarcinoma of the colon, bacterial endocarditis, and subclinical
osteomyelitis.18-22
In most cases, however, the finding of a contaminated
donation has no clear significance to the donors’ health.
The incidence of contamination of apheresis PLT donations with likely skin commensal bacteria is not significantly greater among return donors with prior
confirmed-positive donations compared to the general
donor population. Deferral is not indicated for donors
found to have apheresis PLT donations with likely skin
contaminants, even after two similar occurrences. In contrast, the incidence of possible bacteremia is significantly
greater among return donors with a prior confirmedpositive bacterial culture result with a similar bacterial
isolate than the general population. In the authors’
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