Annual Report - Blood Systems | blood service, testing ... was diagnosed with He - mophagocytic...
Transcript of Annual Report - Blood Systems | blood service, testing ... was diagnosed with He - mophagocytic...
WHAT IS A MURMURATION?
In one of the most astounding
natural phenomena, the murmuration
of starling birds makes it appear as if
each individual bird is physically con-
nected. These birds effortlessly and
dramatically change direction and
perform complicated movements in
flight. As the largest and most
complex organization we’ve ever
been, Blood Systems looks to take
a lesson from these birds and their
ability to move as one. We work
toward a synchronized, nimble and
united company driven by a strong
cause. The stunning movements of
starlings are intentionally executed
together. So shall ours be.
To see a starling murmuration in motion, visit https://tinyurl.com/jsjhfst
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A MESSAGE FROM BLOOD SYSTEMS′ CHAIRMAN & CEO
We continue to build a sustainable, diverse organization—
one conducive to anticipating change
together...”
“
THE YEAR 2016 was indeed a time of
transformation, transition and growth
for Blood Systems®. Not unlike the
murmuration of starlings, we navigat-
ed ever-changing times in as synchro-
nized a way as possible. It was not
without challenge. External forces like
the possible effects of blood donation
on young donors and the continuing
threat of Zika virus prompted swift ac-
tion from our labs to initiate testing.
Creative Testing Solutions® in Tampa
was the first in the country to imple-
ment Zika testing with Blood Systems
Research Institute® and FDA support.
We began ferritin testing on blood
donations from all 16- to 18-year-old
donors. This was in light of studies
indicating that teen repeat blood do-
nors may be more likely to become
iron-deficient than older donors. Clin-
ical evidence suggests that teens with
low ferritin should wait six months to a
year before donating again to rebuild
iron stores. Donor and patient safety
will always be our top priority; at the
same time, these initiatives absolute-
ly affect blood availability. Driving the
cultivation of new donors, especially
those aged 25-45, to rebuild collec-
tions is the primary focus of our new
Donor Marketing team.
Internally, we dramatically reorga-
nized our Blood Centers Division to, as
Blood Services President Dave Green
said, “…make the most of the strengths
of our system: to leverage tremen-
dous talent and experience, to create
a shared infrastructure, to eliminate
unnecessary duplication, to drive out
costs.” This structure better supports
standardization efforts and properly
brings together new business units
and employees, like the 1,400 from
Bonfils Blood Center®, Blood Centers
of the Pacific®, BloodSource®, Inland
Northwest Blood Center®, Lifeblood®
and LifeShare® we welcomed in 2016.
At November’s Launch event, leaders
from across the organization gathered
to celebrate, get acquainted and, well,
launch the next era of Blood Services.
Blood Systems President and CEO Dan Connor enjoys a virtual test drive on the Harley-Davidson that was raffled for use in a blood donation giveaway. The blood centers of the Mountain Division won the raffle.
John S. Lewis, Chairman
Blood Systems adopted Operation-
al Excellence as our methodology for
creating a sustainable culture of day-
to-day learning and leading practic-
es. Based on the acclaimed Shingo
Model™, Operational Excellence em-
powers all employees to be problem
solvers to improve work efficiency in
small and big ways. Training launched
with management-level staff in De-
cember, the beginning of a three-year
assimilation program.
Both Blood Systems Research In-
stitute and BioCARE® expanded their
reach in 2016. BSRI opened a second lo-
cation in Denver and, in order to expand
into new business arenas, BioCARE
became a wholly-owned, for-profit
subsidiary beginning January 1, 2017.
As BioCARE President Linda Matthews
said, “This new status allows BioCARE
and CanyonCARE Rx® to offer a broad-
er product portfolio, becoming more
competitive in the acute and non-acute
markets, which will assist in the contin-
ued growth of our organizations.”
For 2016, the true constant for
Blood Systems was change. In light
of the fact that it looks to carry on
this way, we continue to build a
sustainable, diverse organization—
one conducive to anticipating this
change together (like the murmur-
ation of starlings).
J. Daniel Connor, President & CEO
Tony was diagnosed with He-
mophagocytic Lymphohistiocytosis
(HLH), a life-threatening, rare blood
disease, when he was seven months
old. Blood transfusions sustained
him until a compatible marrow
donor was found. Tony received
his marrow transplant at age two,
enduring harsh chemotherapy and
countless transfusions of platelets,
plasma and red blood cells.
Tony is now 11 and his family is
incredibly active. Tony often leads
the charge. He likes sports, has a
mouthful of braces and loves to be
silly. “Tony is healthy and living a very normal life —what could be
better?” says his mother, Kasey.
“There’s not a day that goes by
when we don’t give thanks for
those who donate blood.”
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BLOOD SERVICESTHE BLOOD CENTERS Division (renamed Blood Services
at midyear) significantly grew blood product production
and distribution in 2016, thanks to the annualized impact of
relationships finalized in 2015. There was an increase of 7.1
percent for red cell collections and 35.2 percent for plate-
let production over 2015, while red cell units and platelets
distributed increased by 8.3 and 29.9 percent respectively.
As blood centers across the country experienced revenue
erosion, Blood Services saw a 12.9 percent increase in total
revenue over 2015.
Without disruption to the daily mission, Blood Services
underwent a comprehensive strategic planning process,
creating “VISION 2020” for the future of the business unit.
This practice totally reorganized operations to employ a
matrix management model. Blood Services corporate func-
tions retained the Source, Make and Deliver supply chain
model, added a Donor Marketing team and formed an Op-
erations Management group. Largely because three of its
four affiliates voted to merge into Blood Systems, Blood
Services retained its integration function and added an in-
dustry relations position. These func-
tions and more delivered the signifi-
cant work required to integrate Bonfils
Blood Center, Blood Centers of the
Pacific, BloodSource, Inland Northwest
Blood Center, Lifeblood and LifeShare
employees by year-end.
In the field, Blood Services divid-
ed into six geographic operating di-
visions, each headed by a Division
President. The resulting structure en-
ables Blood Systems to add new field
operations from future mergers with-
out having to revamp the corporate
support structure every time. In this
way, Blood Services is positioned for
continued growth with minimized
support disruption to established op-
erations as new opportunities arise.
Additionally, a Corporate Authorities council now serves to
codify required points of standardization while maximizing
controlled field flexibility. Blood Services instituted formal
service level agreements from all corporate functions to
drive performance and align effort. All of these changes
were developed under the mantra of “One Company, One
Mission” as the foundation for long-term success along with
the intention of being “standardized where it matters and
nimble where it counts.”
2 0 1 6 H I G H L I G H T S
• Maintained an exceptional compliance record with all
external agencies at all locations
• Instituted Zika testing and implemented the FDA Final
Rule for donor eligibility
• Collected 1,231,000 red cell units and produced
306,847 platelet products for patients
• Converted Inland Northwest Blood Center and
Lifeblood operations to eProgesa, the organization’s
standard blood establishment computer system
• Directed a 100 percent recall initiated by a primary
vendor, assuring patient safety by replacing all collec-
tion sets with a temporary substitute while the vendor
rectified product quality issues
• Implemented pathogen reduction technology at
two sites and began implementation steps for three
other markets
• Employed ferritin testing for all donors age 18 years
and younger
• Extended our Operational Excellence initiative to
include all Blood Services locations
• Instituted a rigorous subcontracting process designed
to achieve unprecedented flexibility in responding to
expanding health system supplier needs
• Achieved a total operational reorganization and
celebrated with an official launch event
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BLOOD DONOR CENTER LOCATIONS
Denver, CO
Sacramento, CA Scottsdale, AZ Lubbock, TX Memphis, TN
Spokane, WA
Blood Centers of the Pacific
BloodSource
Bonfils Blood Center
Community Blood Services
Inland Northwest Blood Center
Lifeblood
LifeShareStates Served
LifeStream (affiliate)
United Blood Services
Divisional Headquarters
Depots (distribution only)
M A P K E Y
Grace battles Sickle Cell Anemia and currently relies on eight units of blood transfused every
four weeks. These transfusions allow her to regularly attend school—something she was previ-
ously unable to do because of immense pain from the disease.
As of the end of March 2017, Grace had received 21 transfusions of 168 units of blood. She will
continue to require these transfusions until she is able to find a bone marrow donor and receive
a successful transplant. Despite everything she faces, Grace is a positive person and passionate
about improving the lives of those fighting blood diseases. She actively works to help recruit
blood donors and tells her friends, family and classmates about the importance of donating
blood and registering to donate bone marrow.
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BIOCARE® & CANYONCARE RX®
THE MODERN BIOCARE business model is built on three
pillars: consignment, field sales representation and a na-
tionwide distribution network (incorporating many of the
Blood Services locations).
Much of the activity at BioCARE in 2016 involved prepar-
ing operations to become a separate, for-profit subsidiary
of Blood Systems effective January 1, 2017. Blood Systems
is the sole shareholder of the now-named BioCARE, Inc.
This large transition did not slow the steady revenue and
contract growth BioCARE has experienced since its estab-
lishment in 1980. BioCARE now maintains a separate gov-
ernance structure, but will remain part of Blood Systems’
consolidated financial statement.
The only change BioCARE President Linda Matthews
foresees in day-to-day activity under the new structure is
further opportunity for growth and expansion. With Blood
Systems’ foresight and support, BioCARE revenues have
grown from $17 million in 2001 to nearly $400 million in
2016, which is just over a 25 percent increase from 2015
revenues. Through careful cost management and stringent
contracting, BioCARE’s net margin increased over 140 per-
cent from 2015.
Several large specialty pharmacy contracts contributed
to the significant growth in the non-acute segment, which
saw an increase of 64 percent in revenue over 2015. This
trend is expected to continue in 2017. Growth in non-acute
sales, coupled with CanyonCARE Rx pharmacy contracts,
will lead to new business development.
Six new factor products were added to the BioCARE
portfolio in 2016 and contributed three percent of annual
revenue. Coagadex® (factor X) sales contributed more than
half of that new revenue. BioCARE is one of only two dis-
tributors selected to carry the Coagadex product. Similarly,
BioCARE was named as the exclusive distributor for CEPRO-
TIN, which is indicated for patients with severe congenital
Protein C deficiency. BioCARE will begin to distribute this
product in 2017.
Other notable accomplishments include the addition of
distribution centers to BioCARE’s network, including loca-
tions in Montvale, New Jersey and Memphis, Tennessee.
2 0 1 6 H I G H L I G H T S
• 2016 revenue increased 25.3 percent over 2015
• Net margin for the year, while slim, more than doubled
from 2015
• Non-acute segment revenues rose from $121,852,000
in 2015 to $188,585,000 in 2016
• Six new factor products contributed $11,783,000 in
annual revenue; nearly half of that amount
($5,615,000) came from Coagadex®
Grace requires eight units of blood exchanged every four
weeks. Despite the struggles she has endured, she is incredibly kind, positive and optimistic.”“
Ten-year-old Adrian was
struck by debris when a car
crashed through the school
fence as he played at recess.
He doesn’t remember the
accident, but witnesses said
that Adrian ran toward class-
mates and tried to get them
away from the vehicle when he
was hit by debris. In all, he
required four surgeries and
seven blood transfusions.
With the injuries to Adrian’s
right leg, amputation was
necessary. A very athletic young
man, Adrian accepted the deci-
sion with quiet determination.
Within six months, he had his
first “blade,” which enabled him
to play “all out”—to be Adrian
again. “I’ll never forget seeing
the stack of bloody towels in
his hospital room,” said Adrian’s
mom, Brandy. “And I know with-
out blood being available that
day, the doctors couldn’t have
helped him.”
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BLOOD SYSTEMS RESEARCH INSTITUTE®
THE ZIKA VIRUS (ZIKV) emergence
and subsequent Food and Drug Ad-
ministration requirement for either
viral marker testing or the use of
pathogen-reduced blood made for an
extraordinarily challenging 2016 for
US blood centers. Blood Systems Re-
search Institute (BSRI) responded to
the ZIKV emergence in previously
naïve populations by initiating a num-
ber of research studies, supported by
over $4.6 million in new funding from
NIH, CDC and BARDA, as well as con-
crete operational activities.
BSRI scientists directed or partic-
ipated in studies to monitor the in-
cidence of ZIKV in leading areas of
the epidemic: Puerto Rico and Brazil.
Samples from infected Brazilian blood
proved instrumental in serving as qual-
ity control samples to develop new nu-
cleic acid tests (NAT) to detect ZIKV in
donated blood samples. BSRI is lead-
ing a large study to enroll and follow
infected donors detected by ZIKV NAT
screening in Puerto Rico and the con-
tinental US to measure the compart-
mentalization and persistence of ZIKV
in blood and body fluids, and is shar-
ing these samples with collaborators
at other institutions to develop more
accurate ZIKV diagnostic assays and
understand mechanisms of ZIKV dis-
ease outcomes.
BSRI also performed key experi-
ments and presented findings to the
FDA demonstrating the relative sen-
sitivity of novel assays developed by
the CDC and commercial companies.
These studies facilitated rapid implementation of ZIKV
blood donor screening in Puerto Rico, allowing resump-
tion of blood donation on the island. Blood donations there
were on hold prior to the availability of a sensitive ZIKV NAT
assay. BSRI serves as the confirmatory lab for assessment
of novel ZIKV NAT assays and pathogen reduction technol-
ogies under the FDA’s Investigational New Drug program.
2 0 1 6 H I G H L I G H T S
• Led 50 different research projects funded by the
National Institutes of Health, the U.S. Department of
Defense, the Bill and Melinda Gates Foundation and
private industry partners such as Grifols Diagnostic
Solutions, Inc. and Terumo BCT
• Continued to lead a major FDA-funded program to mon-
itor the U.S. blood supply for transfusion-transmitted
infections in collaboration with the American Red Cross
• Investigators Nareg Roubinian and Rachael Jackman
were each awarded R01 grants in 2016—an important
step in growing independent research programs
• Completed accrual of approximately 14,000 donors
into the REDS-III RBC-Omics study, including analysis
of red blood cell (RBC) samples for fresh and 42-day
stored RBC stability and DNA samples for genetic
determinants of RBC storage properties
• Discovered that galectin-9, a human carbohydrate-
binding protein, potently reactivates latent HIV
and may therefore serve as a curative agent for
HIV infection
Oliver was born 18 weeks early
and spent the first four months of
his life in the NICU. Doctors told
his family he had a low chance
of survival. He ended up needing
heart surgery and, over the course
of his stay, required 11 units of
blood. His family says Oliver’s color
would change dramatically when
he received blood transfusions. He
would go from looking pale and
sick to happy and healthy. Oliver
is now eight years old and remains
healthy, as well as positive and en-
ergetic. Oliver’s parents are blood
donation advocates—encouraging
others to save the lives of children,
just as generous donors saved
Oliver’s life.
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CREATIVE TESTING SOLUTIONS®
AS THE LARGEST independent US blood donor testing lab-
oratory, Creative Testing Solutions tested approximately 4.5
million donor samples and 4.9 million source plasma sam-
ples in 2016 at its four facilities in Dallas, Phoenix, Seattle
and Tampa. CTS tests approximately 40 percent of the US
blood supply.
In 2016, the Zika virus prompted a required investiga-
tional new drug (IND) test for all US blood donations. Febru-
ary marked the release of the first FDA guidance document
requiring Zika testing in endemic areas in the US; only Amer-
ican territories were considered endemic at that time. CTS’
large Puerto Rican healthcare partner had to shut down its
blood collections until CTS Tampa implemented an individ-
ual donation NAT Zika test under a Roche IND. In less than
six weeks, the CTS Tampa staff implemented this test. The
team had to learn new testing equipment and develop cus-
tomer interfaces to bring the new Zika test online.
In August, the FDA expanded its mandate and blood
collectors in 11 states were required to implement universal
Zika testing within four weeks, followed by the rest of the
country eight weeks later. Since the CTS Tampa lab was op-
erational on the Roche NAT Zika testing platform, the CTS
Dallas and Phoenix labs needed to respond. They met the
aggressive FDA timeline and implemented the Grifols NAT
Zika test platform and developed the client interfaces. CTS
was the only large blood donor testing organization to pro-
vide individual NAT Zika testing for all of its healthcare part-
ners within the timeline.
In October, CTS employed HLA testing as a release test
to conform to the AABB standard 5.4.1.3.1 requiring blood
centers to reduce the risk of transfusion-related acute lung
injury (TRALI). While fewer than 1 in 12,000 transfusion
recipients are affected by TRALI, the 2015 FDA fatality
report cited TRALI as the leading cause of transfusion-relat-
ed deaths at 38 percent over the past five years.
Throughout 2016, CTS continued to provide source plas-
ma testing services to a large plasma fractionation com-
pany, an arrangement made possible because CTS can
provide exceptionally customized testing services. CTS
continues to explore opportunities with additional partners
in this new business line.
Finally, CTS employees continued their Operational Ex-
cellence journey that began in 2014 to solve problems by
engaging everyone, everywhere, every day.
2 0 1 6 H I G H L I G H T S
• Maintained impeccable AABB, EU and FDA compliance
records
• Received exceptional rating on annual client survey
• Established an Operational Excellence workgroup com-
posed of six key employees, removing them from their
daily responsibilities to focus on reengineering CTS
• Continued to meet or exceed healthcare partners’
expectations by providing on-time test results approx-
imately 92 percent of the time
• Established Zika testing in less than six weeks
• Secured one new donor testing, two Babesia testing
and three Zika testing contracts, and extended nine
existing agreements representing over $8 million in
annual revenue
• Remained the single largest provider of Babesia test-
ing for community blood centers, performing over
400,000 individual tests in 2016
BIOCARE, RESEARCH & LABORATORY LOCATIONS
Phoenix, AZ Dallas, TX Tampa, FLSeattle, WA
BioCARE distributorships
Creative Testing Solutions laboratories
M A P K E Y
Blood Systems Research Institute
Transfusion medicine research, laboratory testing and pharmaceutical distribution from coast to coast
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ABOUT BLOOD SYSTEMS
B L O O D S Y S T E M S O R G A N I Z A T I O N
HEADQUARTERED IN SCOTTSDALE, Arizona, and founded
in 1943 as the Salt River Valley Blood Bank, Blood Systems
is one of the nation’s largest blood service providers and
transfusion medicine leaders, and is growing. Blood Sys-
tems’ strength, size, scope, reputation and experience po-
sition us for success as the future of healthcare continues
to unfold.
Hospitals and healthcare systems count on us for ex-
emplary responsiveness and transfusion management ex-
pertise across a large and varied geographic footprint.
Across all of our operating units, we work to help custom-
ers improve patient safety and outcomes, reduce costs and
demonstrate quality conformance.
Blood centers that join Blood Systems benefit from reg-
ulatory compliance excellence, world-class quality support,
reliable donor testing, effective risk management, valuable
shared services and economies of scale across the country.
In 2016 alone, five of the nation’s leading blood centers said
yes to this opportunity and formally joined Blood Systems.
As this report goes to press, we serve more than 1,000
healthcare facilities in 28 states with over 5,000 employees.
We are committed to building an inclusive, diverse
culture of problem solvers and have adopted Operational
Excellence practices at a corporate level. In 2016, Blood
Systems was recognized for the second year in a row as a
“Most Admired Company” by AZ Business Magazine.
Lifeblood
LifeShare
LifeStream(affiliate)
United Blood ServicesInland Northwest
Blood Center
Community Blood Services(wholly owned subsidiary)
Bonfils Blood Center
BloodSource &Blood Centers of
the Pacific
Blood ServicesMedical, Administrativeand Support Services;
Blood Systems Laboratories
Blood SystemsResearch Institute
Creative Testing Solutions(joint venture with OneBlood, ITxM
and Bloodworks Northwest)
Canyon State Insurance(wholly owned subsidiary)
BioCARE, Inc.DBA BioCARE
DBA CanyonCARE Rx(wholly owned subsidiary)
as of Jan. 1, 2017
Blood SystemsA 501(c)(3) nonprofit organization
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LEADERSHIP
J. DANIEL CONNORPresident & Chief Executive Officer
DAVID R. GREENPresident Blood Services
SALLY CAGLIOTIPresident Creative Testing Solutions
LINDA MATTHEWSPresident BioCARE, Inc.
SUSAN L. BARNESExecutive Vice President & Chief Financial Officer
MARY BETH BASSETTExecutive Vice President & Chief Quality Officer
BHAVI A. SHAHExecutive Vice President, General Counsel & Assistant Secretary
RALPH VASSALLO, M.D.Executive Vice President & Chief Medical & Scientific Officer
Executive Officers Board of Trustees
JOHN S. LEWIS, CHAIRConsultant Scottsdale, AZ
HEATHER J. ALLEN, M.D. Oncologist Las Vegas, NV
JAMES R. ALLEN, M.D.Healthcare Executive (ret.) Raleigh, NC
LINDA J. BLESSING, PH.D.Executive (ret.) Sandpoint, ID
ROBERT COLEMedical Technology Executive Lakewood, CO
WILLIAM A. DITTMAN, M.D.Internist Spokane, WA
WILLIAM GATES Attorney Phoenix, AZ
WILLIAM G. GREENAttorney (ret.) Orinda, CA
JOHN P. HARNEY, MBA, FACHEHealthcare Executive (ret.) Denver, CO
MICHAEL C. JENSENAnalyst Redlands, CA
F. LEONARD JOHNSON, M.D.Pediatric Hematologist/ Oncologist (ret.) La Jolla, CA
PIERRE NOEL, M.D.Hematologist Scottsdale, AZ
JAMES W. PETERSONHealthcare Executive Irvine, CA
KATHLEEN PUSHORExecutive Coach Scottsdale, AZ
JAMES SCHRAITHTechnology Executive (ret.) El Dorado Hills, CA
RICHARD B. SPURLOCK, M.D.Pathologist Colorado Springs, CO
PAUL E. STANDER, M.D.Internist Paradise Valley, AZ
RON W. WAECKERLIN, M.D.Pathologist (ret.) Cheyenne, WY
GARY K. WILDEHealthcare Executive Ventura, CA
NANCY WOLLENHealthcare Executive (ret.) Denver, CO
THREE-YEAR F INANCIAL SUMMARY FOR BLOOD SYSTEMS & AFFIL IATES
($ in thousands)
Results of Operations 2016 2015 2014
Blood component service fees $467,717 $422,370 $363,780
Laboratory testing services 223,540 190,008 196,134
Sale of pharmaceutical products 381,917 305,136 205,510
Other services and income 56,264 49,355 43,677
• Total Revenues $1,129,438 $966,869 $809,101
Salaries, wages and benefits 355,926 305,739 284,439
Blood collection, testing supplies 244,572 208,965 196,849
Purchase of pharmaceutical products 359,691 286,892 191,877
Other costs and expenses 172,486 162,258 139,912
• Total Expenses $1,132,675 $963,854 $813,077
Net Income from Operations (3,237) 3,015 (3,976)
Financial Position
Cash and short-term investments $207,099 $225,355 $276,433
Accounts receivable 189,183 165,581 113,953
Inventories 84,905 83,207 71,573
Other current assets 8,923 8,808 12,949
Long-term investments and restricted assets 53,004 26,007 27,280
Property and equipment (net of depreciation) 160,681 134,470 138,869
Deposits and deferred financing costs 6,474 11,256 12,595
• Total Assets $710,269 $654,684 $653,652
Accounts payable and accrued expenses 94,278 72,515 48,259
Accrued salaries, wages and vacations 29,063 21,730 26,403
Current portion of long-term debt 59,093 59,171 56,574
Accrued pension and health benefits 61,522 49,774 61,148
Self-insurance reserve 7,449 6,243 6,001
Long-term debt 55,782 43,660 52,670
• Total Liabilities $307,187 $253,093 $251,055
Net Assets $403,082 $401,591 $402,597
• Total Liabilities and Net Assets $710,269 $654,684 $653,652
Financial results include Blood Systems and affiliates. Blood Systems is a 501 (c)(3) nonprofit, tax-exempt, charitable organization. The financial statements of Blood Systems and its affiliates have been audited by Grant Thornton LLP.
Brian was in a motorcycle accident. Suffering multiple
internal injuries, Brian needed 22 units of blood to save
his life the first night in the hospital. In the 30 days that
followed, he needed additional red blood cells and plate-
lets. It took nearly two years, and the selfless generosity
of blood donors, for him to make a full recovery and go
back to work.
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In August 2016, Emily’s life was saved thanks to blood donors. She experienced
an unexpected and deadly complication during childbirth. Nearly bleeding to death
from disseminated intravascular coagulation or DIC (her blood was unable to clot),
Emily received 32 units of blood and platelets in a single day. She even met her
baby for the first time while receiving a transfusion in the ICU. Today, Emily and her
daughter Lucy are both healthy and inspiring advocates for blood donation.
6210 E. Oak Street Scottsdale, AZ 85257(480) 946-4201 1 (800) 288-2199www.BloodSystems.org
©2017 Blood Systems. All Rights Reserved.