ABC Announces Board of Directors and Officer Nominees

2012 #5
INSIDE:
Our Space: Plasma Saves
Lives ............................. 2
The Transfusion Safety
Officer as a ‘Value
Added’ Service From
Blood Centers ............... 3 Review of Fresh-Frozen
Plasma Clinical Trials
Shows Lacking Efficacy
Evidence....................... 6 ABC and the FABC
Announce 15th Annual
Awards of Excellence
Recipients..................... 8 ABC Provides Comments
on FDA’s HBV Donor
Screening Guidance ... 11 Expression Wines Offers
Valentine’s Day
Promotion to Benefit the
FABC .......................... 12 Blood Service of England
and North Wales
Officially Announces
AIM-II Trial .................. 12 Correspondence to a
Blood Bank CEO in the
Late 1980s.................. 13 BRIEFLY NOTED .......... 14 LEGISLATIVE NEWS ... 16 REGULATORY NEWS .. 17 STOPLIGHT: Status of
America’s Blood
Centers’ Blood Supply....
................................... 18 INFECTIOUS DISEASE
UPDATES .................. 18 MEMBER NEWS ........... 19 MEETINGS: BPAC
Meeting Cancelled ...... 19 POSITIONS AVAILABLE
................................... 20 February 3, 2012
ABC Announces Board of Directors and Officer Nominees
America’s Blood Centers Nominating Committee has announced the ABC Board
of Directors and officer nominations to be voted on at the annual meeting in
Scottsdale, Ariz. in March. David Green, CEO of Mississippi Valley Regional
Blood Center (MVRBC) is nominated for the position of president-elect, with
several other leaders in blood banking nominated to fill the remaining officer and
board member positions.
“I am honored to serve the membership and look
forward to working with the talented staff at ABC. I
am excited to join the many selfless volunteers supporting and guiding ABC into the future,” said Mr.
Green. “ABC is poised to successfully tackle the
many challenges ahead, as are its members.” Currently ABC’s vice president, Mr. Green would serve
a four year term including: one year as presidentelect serving alongside current ABC President Dan
Waxman, MD, two years as president, and one year
as immediate past president.
Susan Rossmann, MD, currently an ABC board
Mississippi Valley Regional
member and chief medical officer at Gulf Coast Re- Blood Center CEO David
gional Blood Center, has been nominated to serve as Green, currently ABC’s vice
is the nominee for
vice president. Frederick Axelrod, MD, CEO, presi- president,
ABC’s president-elect.
dent, and medical director of LifeStream, has been
nominated to continue serving as ABC’s secretary. Martin Grable, currently an
ABC board member and CEO of Community Blood Center of the Carolinas, has
been nominated to serve as treasurer.
The Board of Director nominees are: Chris Staub, vice president of Community
Blood Services at Upstate New York Transplant Services; Jeff Bryant, CEO of
Inland Northwest Blood Center; Diane Merkt, vice president of Administration
and chief compliance officer at the Institute for Transfusion Medicine; Rob Purvis, vice president of Customer Service at New York Blood Center; and Laurie
Sutor, MD, vice president of Medical and Technical Services at Carter BloodCare.
“We have been fortunate that the best and brightest in blood services have wanted
to give back to the community through service on the ABC board and as officers.
(continued on page 3)
ABC Newsletter
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February 3, 2012
OUR SPACE
ABC CEO Jim MacPherson
Plasma Saves Lives
Recently, I was invited to participate in a patient-driven consensus conference by the Plasma Users (PLUS)
coalition to develop recommendations that would reduce barriers to providing an adequate supply of plasma
and the lifesaving products made from it. With further review, those recommendations will be published later
this year.
Sadly, tens of thousands die worldwide each year for lack of plasma products, just as many die for lack of
blood and high-tech drugs. Some countries report that they have few or no residents with hemophilia, mainly
because they die within a few years after birth.
As you can guess, the lack of funding in developing and undeveloped economies is the primary reason for the
disparity of access to plasma products. If money were no object, sufficient plasma likely could be collected
and processed by the current suppliers – both commercial and non-profit – to meet the world’s needs. But
funding is not the only reason; there are also regulatory and legal barriers.
For example, in the developed world the increasing demand for intravenous immune globulin (IVIG) drives
plasma collections. Since IVIG is in higher demand than other plasma products, every year, literally tons of
leftover proteins, including many lifesaving clotting factors, are discarded. The reasons are complicated, and
include various legal and regulatory issues.
Regulators in developed countries require the availability of only the purest and safest plasma products, which
drives up costs. First-world suppliers won’t, and in many cases are legally barred from, making lower cost
products for export to developing countries, because these products are considered “inferior.” Plasma suppliers
in developing countries might be willing to sell at-cost or even donate the leftover proteins to be made into
finished products in needed countries. However, a 10-year effort has yet to resolve complex international liabilities concerning the chance that these products may cause injuries. So, people die because the perfect
product is the enemy of an adequate supply.
However, there is encouraging news on the horizon. The first generation of genetically engineered antihemophilic factor is coming off patent, allowing pharmaceutical companies in developing economies to make
a “generic” product available at lower costs. Also, there has increasingly been success in transplanting missing
genes to patients with protein deficiencies. For such diseases, even partial cures can be far cheaper – and support a higher quality of living – than a lifetime of replacement therapy.
[email protected] 
Visit Jim on Facebook: www.facebook.com/JimMacPhersonABC.
The ABC Newsletter (ISSN #1092-0412) is published 46 times a
year by America’s Blood Centers® and distributed by e-mail.
Contents and views expressed are not official statements of ABC
or its Board of Directors. Copyright 2012 by America’s Blood
Centers. Reproduction of the ABC Newsletter is forbidden unless
permission is granted by the publisher. (ABC members need not
obtain prior permission if proper credit is given.)
America’s Blood Centers
President: Dan A. Waxman, MD
Chief Executive Officer: Jim MacPherson
ABC Publications Editor: Betty Klinck
Business Manager: Leslie Norwood
ABC is an association of not-for-profit, independent community
blood centers that helps its members provide excellence in
transfusion medicine and related health services. ABC provides
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and safety; and in finding efficiencies for the benefit of donors,
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ABC Newsletter
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February 3, 2012
ABC Nominations (continued from page 1)
This is an outstanding slate to serve with Dan Waxman and the other board members during his second
year as ABC President,” said ABC CEO Jim MacPherson.
Mr. Green became MVRBC’s CEO in 1999 after serving for nine years in various executive positions
with the American Red Cross Biomedical Program, including one year as CEO of the American Red
Cross Southeastern Region from 1997-1998. After completing his undergraduate degree at Knox College
in Galesburg, Ill., Mr. Green served for nine years as an active duty Army officer in command and staff
assignments. During his tenure with the Army, Mr. Green earned his master’s degree in administration
from Central Michigan University in Mount Pleasant, Mich.
Mr. Green has served as a director and chair for BCA/hemerica, and as a founding board member for IT
Synergistics, a limited liability corporation dedicated to developing blood centers software systems for
community blood centers. He is active within his local community, serving on the board of directors for
the United Way of the Quad Cities, Friendly House and the Friendly House Foundation, and the DavenportOne and Quad Cities First economic development organizations.
“These may be ‘volunteer’ positions, but board members, and especially the officers, work many hours
every week for the members,” said Mr. MacPherson. “ABC has always been a member driven organization with volunteers at many levels giving thousands of hours to ABC activities each year. This is what
makes ABC an effective and powerful organization even with a small staff.” 
The Transfusion Safety Officer as a ‘Value Added’ Service From Blood Centers
The transfusion safety officer (TSO) is a relatively new and still-developing concept in the US, and has
been around since about the late 1990s in Europe and Canada. A recent journal article shed light on the
growing role of blood centers in providing TSOs, who are responsible for monitoring and improving the
safety of the transfusion process.
Traditionally, TSOs are nurses employed by the hospital, but TSOs employed by the blood center to work
with hospitals offer new opportunities to better connect the blood supplier with the hospital. A TSO coming from the blood center offers the value-added service to hospitals of a centralized expertise in blood
components and their appropriate use.
The article published in the December issue of AABB’s Journal of Blood Services Management focuses
on three TSO programs at blood centers that are members of America’s Blood Centers. The TSOs who
authored the article are: Colleen Slapak, MS MT(ASCP)SBBB, the transfusion safety director of Community Blood Center/Community Tissue Services in Dayton, Ohio; Nanci Fredrich, RN, BSN, the
transfusion safety and blood management officer of BloodCenter of Wisconsin in Milwaukee, Wis.; and
Jeffrey Wagner, BSN, RN, chief transfusion safety officer at Puget Sound Blood Center in Seattle, Wash.
What is a TSO? A TSO improves the safety of the entire transfusion process from testing and typing in
the lab, to ordering blood components, to the actual transfusion, and even analyzing transfusion reactions.
As Mr. Wagner explained it, TSOs cover everything from “bench to bedside,” including educating nurses
and physicians about blood component ordering and administration, acting as a transfusion medi(continued on page 4)
ABC Newsletter
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February 3, 2012
Value of TSOs (continued from page 3)
cine resource, conducting blood component audits, improving blood management and appropriate blood
use, sharing transfusion data among hospitals, identifying appropriate transfusion triggers, and much
more.
“The TSO role is clearly an extremely important practice as advocates for patients and for the blood
supply,” Mr. Wagner told the ABC Newsletter. “We try to educate providers about the indicators for
blood components, and as blood management coordinators, we try to find ways to avoid transfusion.
Transfusion can be dangerous, and has risks like transfusion-transmitted diseases and adverse reactions.
But of course, when transfusion is necessary, we provide the proper education to make sure that the safest
possible transfusion is given to those patients.”
Connecting Hospital and Blood Center. The journal article focuses on the ability of a blood center TSO
to better connect not only departments within hospitals, but also the blood center with the hospital. “Many
hospitals now depend on their blood center for transfusion medicine expertise. This model allows the
hospital and blood center to work together to build a cooperative multidisciplinary team of physicians,
nurses, and clinical laboratory scientists to enhance blood management and improve transfusion safety in
their communities,” Ms. Slapak told the ABC Newsletter.
“I often say that, as TSOs, one of our greatest traits is that we’re able to speak ‘clinician’ and ‘laboratorian.’ So, we act as a liaison between the blood supplier, the testing laboratory, the clinicians who write
orders for blood component administration, the nurses and anesthesiologists who are transfusing, and the
patients,” said Mr. Wagner. “We are a main resource for information about blood components and the
safe administration of blood components.”
When the blood center is providing the TSO, the hospital gains access to one concentrated source of expertise in blood, said Ms. Fredrich. “I also think that the use of a transfusion safety officer in an
institution helps cross all the boundaries – it crosses all departments … It becomes an interdisciplinary
view about transfusion. I think it helps to build relationships at the hospital and with the blood center. A
TSO based at the blood center can be a value-added service, saying to the hospital ‘We have a TSO that
can help you with any transfusion-related issues.’”
Continuing Education. TSOs recognize that physicians and nurses typically receive little or no training
in transfusion medicine, and TSOs work to provide this education, explained Mr. Wagner. By working
with the blood center, the TSO can provide targeted medical education for a specific issue or area of interest within hospitals, said Mr. Wagner. For example, Puget Sound Blood Center employs multiple
physicians specializing in transfusion medicine, allowing the blood center to identify the best expert to
speak to hospital staff on a given subject, such as trauma or obstetrical hemorrhage.
Accrediting organizations such as AABB and the College of American Pathologists (CAP) now require
that certain employees undergo transfusion training, allowing the blood center to offer another “valueadded service” – providing training to meet these requirements, added Ms. Fredrich. Education from the
blood center also provides a view of the entire transfusion chain.
Blood Management and Standardization. Blood management has been a hot topic in the blood community as AABB, America’s Blood Centers, the Food and Drug Administration’s Blood Products
Advisory Committee, and the World Health Organization all stress the importance of appropriate blood
(continued on page 5)
ABC Newsletter
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February 3, 2012
Value of TSOs (continued from page 4)
use to ensure patient safety. Offering a TSO from the blood center provides yet another valuable service
to hospitals as they seek to reduce costs associated with blood transfusions and its risks.
AABB and other agencies such as the Joint Commission are implementing blood management guidelines,
with which a TSO can help hospitals comply. Collecting data using a software or specific data entry protocol provides a “method of standardizing and a method of sharing the information that is collected,” said
Ms. Slapak. Having available data allows hospitals to build educational programs, implement evidencebased changes in transfusion practice, and to see tangible evidence of a program’s effectiveness.
For example, the article describes a project undertaken by Ms. Fredrich at BloodCenter of Wisconsin
(BCW) to reduce ordering of preoperative autologous blood donation (PAD) that often can be wasted. A
2008 PAD audit revealed that there was great variation in ordering practice and wastage of PAD units.
The TSO and physicians at BCW provided data and educational material about PAD, thus reducing physician orders by 14 percent in 2009 and by an additional 45 percent in 2010.
A TSO can act as a central blood management resource so that hospitals can more easily access transfusion information, and using standardized data collection methods allows for benchmarking and forming of
best practices, said Ms. Fredrich. She noted that sharing a problem and solution found at one hospital can
improve transfusion practice at other hospitals.
The Future of TSOs. The TSO role is a more common specialty for medical technologists and nurses in
some European countries and parts of Canada, as there are only about 30 to 40 in the US, said Mr. Wagner. However, the interest in this role may continue to increase as transfusion safety and blood
management take the forefront, said Mr. Wagner.
Adding a TSO position may not seem practical for blood centers struggling with tough economic times.
However, this transfusion expert can help hospitals to save resources by encouraging appropriate blood
use, which improves customer service to the hospital, said Mr. Wagner.
“Our services often focus on blood conservation methods … that are valuable to the hospitals – and that
helps maintain customers” said Mr. Wagner. “When we’re in the hospital, at the bedside, there cannot be
a better conduit of customer service than to have someone right there in the hospital to aid in appropriate
and safe transfusion. TSOs clearly offer an important value-added service,” said Mr. Wagner.
[Editor’s Note: For an article about FDA promoting TSOs, please see ABC Newsletter, 2/18/11.]
Citation: Slapak, et al. Transfusion safety: is this the business of blood centers? Transfusion. 2011
Dec;51(12 Pt 2):2767-71.
– Betty Klinck, [email protected] 
We Welcome Your Letters
The ABC Newsletter welcomes letters from its readers on any blood-related topic that might be of interest to
ABC members. Letters should be kept relatively short and to the point, preferably about a topic that has recently
been covered in the ABC Newsletter. Letters are subject to editing for brevity and good taste. Please send letters
to ABC Publications Editor Betty Klinck at [email protected] or fax them to (202) 393-1282.
Please include your correct title and organization as well as your phone number. The deadline for letters is
Wednesday to make it into the next newsletter.
ABC Newsletter
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February 3, 2012
Review of Fresh-Frozen Plasma Clinical Trials Shows Lacking Efficacy Evidence
In recent years, use of frozen plasma (FP) to stop or prevent bleeding has increased, with little evidence
supporting the effectiveness of this treatment. A recent systematic review of randomized controlled trials
(RCTs) evaluating efficacy of FP transfusion show that it often carries no benefits for the patient, supporting the findings of a previous study.
The recent RCT review was conducted by Simon Stanworth and colleagues of the UK’s National Health
Service Blood and Transplant (NHSBT), and was published online in Transfusion on Jan. 18. This study
is an update of a 2004 review that evaluated FP RCTs from 1964 to 2004, finding “a lack of RCT evidence to support the effectiveness of FP usage in most of the clinical conditions and specifically in
prophylaxis.”
The researchers sought to assess the methodological quality of such studies conducted from September
2002 through July 2011. They aimed to deduce the effectiveness of FP used to prevent bleeding (prophylaxis) and to stop bleeding (therapeutic) by measuring FP’s effect on survival. A large multicenter study
showed that about 50 percent of patients in the intensive care unit received fresh-frozen plasma (FFP)
without evidence of clinical bleeding. Guidelines for FFP use, published by the British Committee for
Standards in Hematology (BCSH), were used in evaluating the FP RCTs in the present study.
In this study the term “FP,” included FFP (frozen within a short specified period after collection before
storage) and plasma frozen at later intervals (up to 24 hours) after collection (FP or FP24).
Methods of Evaluation. The researchers identified RCTs by searching several research databases and
decided which to include using the following criteria: there must have been at least two groups in the
study, it must have been randomized, one of the study arms must have included FP or fresh plasma as an
intervention, and it must have included results on relevant clinical or laboratory outcomes. The primary
outcome measure was the effect of FP on survival and mortality, and secondary outcomes were: length of
hospital stay or speed of recovery, blood loss, coagulation test abnormalities, and FP-related side effects.
Trials Included for Review. The investigators found 1,252 citations in their initial search, of which
1,193 were excluded after evaluation. This study included 21 publications of RCTs on FP transfusion
published since the 2004 review, which were divided into clinical groupings that included liver disease,
cardiovascular surgery, reversal of warfarin treatment effect, thrombotic thrombocytopenic purpura
(TTP), and therapeutic plasma exchange by prophylactic or therapeutic indications. The researchers separately described eight ongoing and four recently completed trials awaiting publication.
RCT Quality. “Many trials suffered from methodological limitations highlighted in an earlier systematic
review,” wrote the authors. Only two trials, which investigated FP use in head injury and Dengue fever,
fulfilled all criteria of study quality assessment and reported adequate methods or randomization, allocation, concealment, and double blinding. The authors reported that only a small number of trials had
adequate blinding and methods of randomization.
No Benefits From FP Treatment For Various Conditions. Liver disease can be associated with coagulopathy and lead to increased risk of bleeding. When combined with the 2004 review, 10 total trials
enrolling 310 patients evaluated the use of FP in patients with liver disease, with seven addressing prophylactic use and three addressing therapeutic use. No significant benefits, across a range of clinical
indications and outcomes, including transfusion requirement and coagulation test abnormalities, were
reported.
(continued on page 7)
ABC Newsletter
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February 3, 2012
FP Review (continued from page 6)
This review added six trials addressing FP use in cardiac surgery, of which five observed infants, neonates, or children undergoing cardiopulmonary bypass surgery, and one observed patients over 18 years
old. No significant benefits of FP use in cardiac surgery were identified. A meta-analysis of eight RCTs
assessing plasma use in cardiac surgery patients, both from the 2004 and the current review, showed that
there was no significant difference in 24-hour post-operative blood loss between the FP and the control
groups. In total, 19 trials observing 948 patients undergoing cardiac surgery were evaluated. No consistent medical benefit was reported.
Two trials assessed the use of FP for treatment of warfarin-related overanticoagulation. Warfarin is a drug
used to prevent blood clots. These studies showed more rapid international normalized ratio (INR) correction by using coagulation factor concentrates as opposed to plasma, and with plasma compared to vitamin
K. Neither study reported mortality, but in the study comparing plasma use with vitamin K, FP was associated with fluid overload, increased transfusion requirement, and increased postoperative oozing
secondary to inadequately corrected INR.
Therapeutic Plasma Exchange. Therapeutic plasma exchange is used to treat TTP, a blood disorder that
causes blood clots to form in small blood vessels throughout the body, although there is uncertainty regarding optimal dose and type of plasma. Two new trials were added to this study evaluating plasma to
treat TTP, with one comparing FP to cryosupernatant plasma and the other comparing FP with photochemically treated frozen plasma (PT-FP). There were no significant differences in remission rates
between the different FP study groups, similar to the 2004 review findings.
The investigators also evaluated FP use in situations such as, plasma exchange in other clinical settings
and FP use in disseminated intravascular coagulopathy and massive bleeding, dengue fever, head injury,
burns, and organophosphate poisoning. In patients with hepatitis, mortality was significantly reduced in
the plasma exchange group (compared to patients with only standard treatments). Another trial found that
liver failure patients who received plasma exchange combined with hemofiltration had better survival
rates than those who received plasma exchange only and those receiving only standard treatment.
Comparison of FP with isotonic saline for treatment of thrombocytopenia in dengue fever patients concluded that FP may only benefit patients in the earlier stages of the disease. In patients with head injuries
receiving FP, the mortality rate was significantly higher and frequency of delayed traumatic intracerebral
hemorrhage was increased when compared with infusion of isotonic saline.
Conclusions. The authors note that over the past 50 years, 80 RCTs have been completed in the area of
FP use to stop or prevent bleeding, but there is still not sufficient evidence to “inform the safe and effective use of plasma transfusion.” They reiterate that there is little evidence of significant benefit from FP
infusion, and that the meta-analysis of cardiac trials showed no significant difference between the experimental and control arms in blood loss. The trials suffered from similar limitations to those noted in a
previous review carried out in 2004.
“Given the well-recognized mantra that the safest transfusion is that which is not given unless clearly
indicated,” the authors say that they hope that blood transfusion services commission new high-quality
plasma trials to determine efficacy and appropriate transfusion indicators.
Citation: Stanworth, S et al. Is fresh-frozen plasma clinically effective? An update of a systematic review
of randomized controlled trials. Transfusion. 18 Jan. 2012 [E-pub ahead of print]. 
ABC Newsletter
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February 3, 2012
INSIDE ABC
ABC and the FABC Announce 15th Annual Awards of Excellence Recipients
America’s Blood Centers and the Foundation for America’s Blood Centers (FABC) have announced recipients of the 15th Annual Awards of Excellence, most of which will be presented at the Awards banquet on
March 26. Recipients of the Corporation of the Year, Larry Frederick, National Partner of the Year, Outstanding Humanitarian Service, Thomas F. Zuck Lifetime Achievement, and the President’s Awards, will
be recognized at the ABC Annual Meeting during the banquet. Awards for the following will be given out
at local presentations: Creative Blood Drive, Most Productive Blood Drive, School Blood Drive, and the
Media of the Year Awards.
Thomas F. Zuck Lifetime Achievement Award. Celso Bianco, MD, ABC’s executive vice president, will be receiving the Thomas F. Zuck Lifetime Achievement
Award, which honors an individual for a lifetime achievement of the application of
clinical/medical and scientific research to improve methods of blood collection and
safety/efficacy of products provided to patients. Dr. Bianco was nominated by Carter BloodCare and Mississippi Valley Regional Blood Center (MVRBC). Working
in blood banking and transfusion medicine since the 1970s, Dr. Bianco has become
a well-respected and influential leader in transfusion medicine research and blood
safety policy over the years.
Prior to joining ABC, Dr. Bianco was the vice president for Medical Affairs at New York Blood Center,
where he began working in issues related to transfusion transmitted diseases and blood safety in 1982. Dr.
Bianco has published many scientific papers on plasma membrane receptors of white cells, immunology,
infectious disease, plasma proteins, and transfusion medicine. He is a member of AABB’s Transfusion
Transmitted Diseases Committee, the American Society for Clinical Investigation, and the American Society of Hematology. He was also a member of the Advisory Committee on Blood Safety and Availability
of the US Department of Health and Human Services, and is currently the industry representative on the
Blood Products Advisory Committee of the Food and Drug Administration.
“One can list the publications, positions, and accolades that Celso has accumulated … It is more difficult,
but maybe more important to measure what we all know is the foundation of his influence,” Louis Katz,
MD, executive vice president of Medical Affairs at MVRBC, wrote in his nomination. “That is the certainty that anyone who dials his number or sends him an e-mail, whether they agree on a policy matter or
not, will be heard, treated with respect, and where appropriate, mentored.”
President’s Award. Michelle Stefan, vice president of corporate and community services at Carter
BloodCare and chair of the Board of the Foundation for America’s Blood Centers (FABC), will receive
the President’s Award, which is awarded at the discretion of the ABC president in consultation with the
Board of Directors. Ms. Stefan has served on the FABC Board since April 2004 and became chair in
2009. Aside from her work for the FABC, Ms. Stefan has volunteered to facilitate a number of sessions
and meetings for ABC and served on ABC’s Board of Directors.
ABC President Dan Waxman, MD, offered a long list of accomplishments when asked why he nominated
Ms. Stefan for this award. She has facilitated strategic planning sessions for the Board of Directors, AIM
(continued on page 9)
ABC Newsletter
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February 3, 2012
INSIDE ABC (continued from page 8)
users group sessions, Task Force meetings on marketing and competition, a scenario planning session
focused on competition, meetings between ABC and the National Marrow Donors Program, and much
more. Before coming to Carter BloodCare, Ms. Stefan worked at Memorial Blood Centers in Minneapolis, where she was the director of Transfusion Medicine and then the vice president of Technical
Operations.
Outstanding Humanitarian Service Award. The Salisbury Lions Club of Salisbury, Md., will receive
the Outstanding Humanitarian Service Award, which recognizes a community organization that encourages the spirit of volunteerism among citizens in their community. The Salisbury Lions Club is a
community service organization that helps those in need with support of the Lions Club International
Foundation. The group was nominated for the award by Blood Bank of Delmarva, Newark, Del., which
was essentially formed with the help of The Salisbury Lions Club. In 1960, the Lions Club Health and
Welfare Committee began providing support to form a stable blood supply for the local community in the
Lower Eastern Shore of Maryland, and were instrumental in forming the Blood Bank of the Eastern
Shore, which is today the Blood Bank of Delmarva.
“While it is impossible to calculate how many pints of blood their members have donated since those
early days, it is clear that without them and their support, we would not be the successful blood bank that
we are today,” Mary G. Konwinski of Blood Bank of Delmarva said in the nomination.
Larry Frederick Award. Judy Socha, Addison Community Blood Commission chairperson, will receive
the Larry Frederick Award, which honors an individual for his or her community leadership in raising
awareness for the need for blood donations. Ms. Socha was nominated by LifeSource in Chicago, which
has benefited from Ms. Socha’s 40 years of service raising awareness of the need for blood donation. Ms.
Socha became a blood donation advocate after her son was diagnosed with leukemia in 1971, and has
since chaired 217, blood drives collecting 27,562 units of blood. She also helped to form the Addison
Community Blood Commission in 1976, which has helped to connect with organizations, high schools,
and businesses to hold blood drives. She also continues to promote blood donation through the TV appearances, newspaper articles, local meetings, and other speaking engagements.
National Partner of the Year Award. The National Cesar E. Chavez Blood Drive Challenge, receiving
this year’s National Partner of the Year Award, provides member blood centers the unique opportunity to
reach out to students, especially of Hispanic/Latino descent, encouraging them to promote health education and saving lives through blood donation. Since its inception over four years ago, the campaign has
grown widely, reaching hundreds of campuses across the country and collecting thousands of units of
blood for their local communities.
Corporation of the Year Award. The Daytona International Speedway is receiving the Corporation of
the Year Award, which recognizes a corporation that demonstrates an exceptional commitment to the
volunteer blood community. Florida’s Blood Centers (FBC) (now part of OneBlood) nominated Daytona
International Speedway, which teamed up with FBC for the past six years to host the annual 9/11 Blood
and Marrow Drive. Also, Dean Kurtz, chief guest services officer for Daytona International Speedway,
leads the team that plans the 9/11 drive each year, and sits on FBC’s Board of Directors. He was recently
inducted into the Fenwal Blood Donation Hall of Fame.
Other Awards. The following awards will be sent out and awarded at local ceremonies:
(continued on page 10)
ABC Newsletter
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February 3, 2012
INSIDE ABC (continued from page 9)




Media of the Year Award: 107.9 WSRZ radio station; nominated by Suncoast Communities Blood Bank.
School Blood Drive Award: Carrington College, Spokane Valley, Wash.; nominated by Inland Northwest Blood Center.
Most Productive Blood Drive Awards: (Small) Corpus Christi Army Depot, Corpus Christi,
Texas; nominated by Coastal Bend Blood Center. (Large) America Segura, Avondale, Ariz.;
nominated by United Blood Services.
Most Creative Blood Drive Awards: (Small) Marian Ibara Kapp, Lawrenceville, N.J.; nominated by Community Blood Council of New Jersey. (Medium) Eddie Check/Nisus
Corporation, Rockford, Tenn.; nominated by MEDIC Regional Blood Center. (Large) Chicago Blackhawks, Chicago, Ill.; nominated by LifeSource.
Foundation Awards. The Institute for Transfusion Medicine (ITxM) will receive the President’s Circle
award for financial contributions between $100,000 and $249,999. Abbott Laboratories, Johnson & Johnson Development Corp., and Ortho Clinical Diagnostics will receive the Pacesetter Award for financial
contributions of $50,000-$74,999 each to support FABC events and initiatives dedicated to providing a
safe and adequate blood supply through ABC members.
Peter Scott, CEO of Alignment Enterprises, will receive the 2011 Volunteer of
the Year Award for his work in providing vital event production support to the
FABC and the Preeclampsia Foundation’s “Saving Grace: A Night of Hope and
Gratitude” dinner gala. The Saving Grace gala raised money to support the lifesaving work of the FABC and the Preeclampsia Foundation. As Lauren Larsen,
then-president of the FABC, planned the gala, Mr. Scott reached out to her, offering his team’s full support in producing the event.
Mr. Scott’s team from Alignment Enterprises provided assistance in writing,
production management, audio-visual, photography, and videography. He also
scheduled weekly conference calls to develop the live program for the gala, and
secured the (pro bono) help of a world-renowned musical composer and conductor. Mr. Scott and his team provided support throughout the entire event.
Peter Scott, CEO of Alignment Enterprises and the
FABC’s 2011 Volunteer of
the Year.
“Pete has always been the type of person to jump in when he sees a cause that needs a helping hand. His
commitment to his work has made him a leader in the meeting production field. But it is his enormous
heart that makes him so special,” said Mary Richardson, senior director of Communications for Johnson
& Johnson.
Incept will receive the President’s Award, recognizing the organization’s commitment to promoting voluntary blood donation. Incept has provided a grant to establish “Conversations About Life,” America’s
Blood Centers’ national speakers’ bureau. The program, which will be officially launched at ABC’s 2012
Annual Meeting, includes a roster of dynamic, engaging, and compassionate individuals who have been
touched by blood donation directly or through a family member. Incept had the vision to fund this program to allow member blood centers to request appearances by these speakers at their local events.
Receiving the ITxM Award for Excellence in Technical Operations will be Marjorie Doty,
MT(ASCP)SBB, the Transfusion Medicine Academic Center manager at Floridas Blood Services
(continued on page 11)
ABC Newsletter
-11-
February 3, 2012
INSIDE ABC (continued from page 10)
(FBS), now part of OneBlood. FBS nominated Ms. Doty for her nine years of service tirelessly educating
students at many levels about the field of blood banking. Ms. Doty has educated medical laboratory technicians, medical technologists, and medical students. She also created a seven-month Blood Banking
Technology Program that has been accepted by the state of Florida to prepare bachelor of science students
to become medical technologists licensed in immunohematology.
Coastal Bend Blood Center’s Donor Development Department will receive the Terumo BCT Award for
its High School Heroes Challenge program. Coastal Bend Blood Center’s high school program began
with only a handful of high schools participating, but since 2003, the blood center’s Donor Development
Department has worked to expand and develop this program. Beginning with 6,585 donations in 20032004, Coastal Bend Blood Center’s High School Heroes Challenge now has participation from 48 area
high schools across 10 county service areas, collecting 11,328 units during the 2010-2011 school year.
ABC Provides Comments on FDA’s HBV Donor Screening Guidance
America’s Blood Centers (ABC) recently submitted comments to the Food and Drug Administration on
its Nov. 28 draft guidance: “Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
Whole Blood and Blood Components Including Source Plasma, to Reduce the Risk of Transmission of
Hepatitis B Virus.”
FDA’s guidance recommended the use of nucleic acid testing (NAT) for screening of donated blood for
hepatitis B virus (HBV) to reduce the risk of HBV transmission from transfusion. FDA stated that testing
blood for HBV surface antigen (HBsAg) and antibodies against HBV core antigen (anti-HBc) should
continue. By implementing HBV NAT testing, FDA hopes to reduce potential infections during the window period. NAT testing shows positive results two to five weeks after infection, reducing the 40-day
window period of HBsAg testing.
In its comments, ABC states that members endorse the recommendation for implementation of NAT for
HBV both to reduce the risk of transmission of HBV by transfusion and for the requalification of donors
with false positive results. However, ABC members are concerned by the increased sensitivity requirements for detection set forth in the draft guidance, to 100 IU/ml per sample either tested individually or in
a minipool.
The comments conclude that in order to guarantee the availability of the approved assays from the two
manufacturers currently in the market, FDA should accept the recommendation from the April 2009 Food
and Drug Administration Blood Products Advisory Committee meeting for a minimum sensitivity of 200
IU/ml. Alternatively, ABC suggests that in case the biologics licensing application submission for the
new Gen-Probe assay is approved, FDA could wait until publication of the final Gen-Probe decision before issuing the final guidance including the increased
sensitivity. ABC also requested that sufficient time be given for test implementation at blood screening
laboratories and blood collection facilities.
Members may view ABC’s comments in MCN 12-020 at:
http://members.americasblood.org/go.cfm?do=FileCenter.List&category=MCNs.
(continued on page 12)
ABC Newsletter
-12-
February 3, 2012
INSIDE ABC (continued from page 11)
Expression Wines Offers Valentine’s Day Promotion to Benefit the FABC
Expression Wines is offering a Valentine’s Day promotion in which the company will donate $50 to the
Foundation for America’s Blood Centers (FABC) for every 6-pack purchase of 2008 Gap’s Crown Vineyard Chardonnay or 2007 Roserock Vineyard Pinot Noir through Feb. 29. Expression Wines has been
offering its “Case for a Cause” promotion to benefit the FABC since last spring.
Through “Case for a Cause,” Expression Wines donates a portion of
its proceeds from wine case purchases to a deserving charity or nonprofit group. “With a Case for a Cause benefiting the FABC, you give
the gift of wine to the one you love and the gift of hope to someone
else’s loved one,” says the Expression Wines website.
Those participating in the “Case for a Cause” promotion will also save up to $90 on their purchase of the
selected wines. Expression Wines began working with the FABC after Megan O’Donnell, direct sales and
wine club manager at Expression, poured wine at a book party for past-FABC President Lauren Larsen’s
Zuzu’s Petals: A True Story of Second Chances. Ms. O’Donnell was inspired to help the FABC by Ms.
Larsen’s description of a collaborative FABC initiative called The Nigeria Project, which works to provide safe blood in Nigeria.
Those interested in purchasing a “Case for a Cause” may visit Expression Wines’ website:
www.expressionwine.com/Wines/A-Case-For-A-Cause. More information about companies donating to
the FABC is available at: www.thefabc.org/company_heart.html. 
Blood Service of England and North Wales Officially Announces AIM-II Trial
The UK’s National Health Service and Blood Transplant (NHSBT) officially announced to the
public in a press release on Wednesday that it is using America’s Blood Centers’ Appropriate Inventory Management-II software in an effort to better understand how its hospitals are using blood
and blood products. NHSBT finalized the agreement in November, shortly after the UK’s Department of Health recommended that NHSBT and hospitals in England continue to build on their
previous success and improve in the area of blood management (see ABC Newsletter,11/10/11).
“We hope that the trial will provide valuable insights into how blood is used in hospitals while
maintaining patient confidentiality. This new source of information will be used by hospitals to
help maximize the use of blood and minimize unnecessary transfusions,” Lynda Hamlyn, chief
executive of NHSBT, said in the press release. “It will also help NHSBT to improve how it plans
and collects sufficient amounts of blood so that together we can continue to ensure a sustainable
blood supply for the patients of the future.” ABC and NHSBT issued the press release jointly. It is
available on ABC’s website at: www.americasblood.org/download/releases/AIM_II_Pilot_12.pdf.
Save the Date for a 3-day celebration event
commemorating America’s Blood Centers’ 50th Anniversary
at the ABC Annual Meeting, Scottsdale, Arizona
Saturday, March 24
Odes to the 50th
Jenni Alpert mini-concert, cocktail reception and putting green competition benefiting the Foundation for America’s Blood Centers.
Co-hosted by
The Foundation For
MEMBER OWNED. MEMBER DRIVEN.
America’s Blood Centers
Emerging pop songstress Jenni Alpert has a powerful sultry voice whose honest rich songwriting and soothing musical
melodies grab listeners in every corner. Recently Jenni joined ABC’s speakers’ bureau “Conversations About Life” after
embarking on her “Blood Driven” tour last summer where she covered over 5,000 miles of the West Coast performing
and speaking at blood drives, blood centers, children’s hospitals and local venues to raise awareness on blood donation.
Jenni has performed live with artists such as Sara Bareilles, Jon Allen, and Regina Spektor. Her music has been featured
on TV shows such as Castle, CSI Miami, Lipstick Jungle, and MTV’s The Real World. Jenni’s mini-concert will kick off
the celebrations, followed by an outdoor cocktail reception and a putting green competition available to anyone wishing
to enter. Proceeds from the putting green competition will benefit the Foundation for America’s Blood Centers.
Location: Scottsdale Plaza Resort Cypress Court (outdoor space), 5 to 7 p.m.
Sunday, March 25
The CBBC Supper Club ’62
Hosted by
Where were you in ’62? Lawrence of Arabia was best picture, we loved Lucy on TV, Walter Cronkite
was the new anchor for the CBS Evening News, we rocked to The Twist, and To Kill a Mockingbird
was on the nightstand. Imagine yourself in that Camelot year at the founding of CBBC, Community
Blood Bank Council, forerunner of today’s America’s Blood Centers. Join our host (and one of ABC’s
founders) Blood Systems for an evening of cocktails, dinner and dancing at The CBBC Supper Club
’62. Attire is business casual, early ’60s vintage or inspired by the era.
Location: The Westin Kierland Resort & Spa (bus transportation provided), 5:30 to 10 p.m.
Monday, March 26
Awards of Excellence and 50th Anniversary Banquet
Begin the evening with a trip down memory lane, complete with a photographic
timeline exhibit and video commemorating the last half century of blood banking,
followed by the Awards of Excellence and 50th Anniversary Banquet. We will
recognize individuals and organizations that have a long-standing record of support
and collaboration with ABC, its members and the blood banking community.
Join us for cocktails, dinner, and reminiscing as we close our 3-day celebration by
honoring ABC and FABC award recipients. Business attire.
Location: Scottsdale Plaza Resort Grande Ballroom, 6 to 9 p.m.
To receive an invite, email [email protected] with the subject line “ABC Golden Anniversary Invitation.”
ABC Newsletter
-13-
February 3, 2012
Correspondence to a Blood Bank CEO in the Late 1980s
[Editor’s Note: The following letter was submitted in response to the ABC Newsletter’s request for blood
banking-related stories as ABC approaches its 50th Anniversary Celebration this March in Scottsdale, Ariz.
Increasingly sensitive tests for transmissible infectious diseases have made major contributions to transfusion
safety, however, these welcome advances have occasionally provoked dismaying consequences for those
blood donors who fall victim to non-specificity in the assays. This poignant correspondence is a record of such
an instance, caused by biological false positivity using the Wassermann Reaction, an early test for syphilis. It
serves as a reminder that there are continuing challenges when donors must be counseled about laboratory test
results. This letter is unedited except for redaction of names to maintain privacy.]
Dear [Name Redacted]:
I am writing to complain.
Last week my husband got a letter from your blood bank (I open all his mail these days ever since that
dreadful [name redacted] that he met at the yard sale started writing to him).
The letter said that he was probably false positive for venerable [sic] disease and that can happen because
old people get positive oftener. So, is he probably false, or probably positive, or probably diseased, or just
old. Really, I was at my wits [sic] end so I phoned the local [acronym of a national organization redacted]. They said they were not your company. They could not help. They insisted I tell Wilbur never to
donate with them (because of his venerable condition you see). They said I should phone the [another
organization’s acronym redacted]. So I did.
They said they only make the rules and what my husband did was up to him. Then I told the ladies at my
book club about Wilbur’s disease. I thought they could help.
Now they will hardly talk to me and have suspended my membership. They said I must bring my own tea
cup if they let me back.
So, I thought I would stone two birds with one kill [sic] and go to your blood center again and donate and
ask someone to explain Wilbur’s venerable issue. But they told me (and this was in front of my neighbor
and loud enough for Wilma, who always donates with me, to hear) that seeing that Wilbur had venerable
problems and seeing I am his wife I am also probably positively false and probably venerable too, I could
not donate. Well I was nearly in tears, and went straight to our pastor who promised to pray that Wilbur
would mend his wicked ways and he would ask all the congregation to join him in prayer this Sunday. I
don’t think he understands. So I haven’t told Wilbur and I really don’t know what to say to him.
This is all your fault.
Yours sincerely,
Mildred [name redacted] 
ABC Newsletter
-14-
February 3, 2012
BRIEFLY NOTED
The American Society of Hematology (ASH) issued a position statement last week opposing the
National Collegiate Athletic Association (NCAA) requirement to test college athletes for sickle cell
trait. Sickle cell disease affects 8 to 10 percent of African-Americans, and some people from South and
Central America, the Caribbean, and the Middle East. It is hereditary and is caused by an abnormal type
of hemoglobin that makes red blood cells assume a crescent shape when in an environment with low oxygen. These red cells have difficulty circulating through tissues and are eliminated, resulting in anemia,
pain, disability, and in some cases death. People with sickle cell trait, however, do not have sickle cell
disease, because they have only one defective gene, unlike sickle cell disease patients, who have two.
Those with sickle cell trait often lead normal lives, largely unaffected by the genetic abnormality except
in rare cases when extreme physical exertion causes rhabdomyolysis, the rapid breakdown of skeletal
muscle. In 2010, the NCAA adopted a policy requiring that all Division I athletes undergo sickle cell trait
testing. Students may provide prior test results or sign a waiver of liability against the university and the
NCAA to opt out of testing. This requirement was sparked by a lawsuit against the NCAA and Rice University following the death of a football player after practice caused by acute exertional rhabdomyolysis,
which was linked to sickle cell trait. ASH argues that the NCAA policy does not necessarily protect students from stress or exertion-related injuries, and suggested that the NCAA instead implement several
interventions to protect all athletes, similar to those used by the US Army since 1996. The interventions
include: environment-based work-rest cycles, heat acclimation monitoring, guidelines for hydration, and
rapid detection of treatment for heat illness. The NCAA’s policy may actually harm students and stigmatize those with sickle cell trait, argued ASH, as the current policy assigns risk to sickle cell trait carriers
where it may not be warranted and fails to provide students with counseling about this condition. More
information about ASH’s position is available at: www.hematology.org/Advocacy/PolicyStatements/7704.aspx. (Sources: ASH statement, 1/26/12; MedPage Today, 1/27/12)
Researchers recently used cord blood cells to successfully treat type 1 diabetes in a small clinical
trial, reported USA Today on Jan. 13. The researchers tested a treatment they developed called Stem
Cell Educator therapy, which uses stem cells derived from cord blood to “re-educate” immune system T
cells in people with type 1 diabetes to induce production of insulin by the pancreas. Type 1 diabetes develops when the body’s own immune system attacks and destroys the insulin-producing islet beta cells in
the pancreas. As a result, glucose cannot be metabolized, reaches dangerous levels, and produces organ
damage. In order to survive, patients with type 1 diabetes require insulin injections. This new treatment
could reduce the amount of insulin needed to survive. Results of phase 1 and 2 clinical trials led by Yong
Zhao, MD, of the University of Illinois in Chicago, were published online on Jan. 10 in the open-access
journal BMC Medicine. The study included 15 patients in China with a median age of 29 years and a median diabetic history of eight years. The Stem Cell Educator therapy works by circulating the patient’s
blood through a closed-loop system that separates the lymphocytes from the whole blood and briefly cocultures them with adherent cord blood stem cells before returning the lymphocytes back into the patient’s body. Patients were randomly assigned to a single treatment or to a control treatment without
adherent cord blood stem cells. The primary endpoints (target outcomes) were feasibility of therapy, safety through 12 weeks of post-treatment, and preliminary efficacy evaluation for the improvement of beta
cell function through 24 weeks. The researchers measured C-peptide, a protein byproduct of insulin production, and found that the educator therapy group had improved levels of C-peptide at 12 weeks. The
levels continued to improve until 24 weeks, and remained stable through the follow-up at 40 weeks.
There were no changes in C-peptide in the control group. The average daily dose of insulin dropped almost 39 percent after 12 weeks with the group with some beta cell function and 25 percent in those with
no beta cell function, suggesting that the group with no beta cell function now produced insulin.
(continued on page 15)
ABC Newsletter
-15-
February 3, 2012
BRIEFLY NOTED (continued from page 14)
The treatment appears safe with no risk of rejection, as no significant side-effects were reported other
than some soreness where blood was taken and returned in the arm during the trial. The entire study is
available at: www.biomedcentral.com/1741-7015/10/3/abstract. (Source: USA Today, 1/13/12)
A group of video gamers has successfully created the first crowd-sourced redesign of a protein, reported Nature News on Jan 22. The research team, led by Zoran Popovic, director of the Center for
Game Science, and biochemist David Baker, both of the University of Washington in Seattle, reported
their findings on Jan. 22 in Nature Biotechnology. The researchers allowed gamers to play the proteinfolding game Foldit on their home computers in search of the best-scoring (lowest-energy) configurations, explained Nature News. The researchers have previously reported success by Foldit players in
folding proteins, but the latest work moves into the realm of protein design. “By posing a series of puzzles to Foldit players and then testing variations in the players’ best designs in the lab, researchers have
created an enzyme with more than 18-fold higher activity than the original,” reported Nature News. The
project has progressed from volunteers donating their computers’ spare processing power for proteinstructure research, to actively predicating protein structures, and now to designing new proteins. There are
currently 240,000 registered Foldit players, 2,200 of whom were active last week. The latest efforts led to
the design of an enzyme that catalyzes one of a family of workhorse reactions in synthetic chemistry
called Diels-Alder reactions, reported Nature News. Members in this huge family of reactions are used
throughout various industries to synthesize everything from drugs to pesticides. There are no immediate
applications for this particular Diels-Alder reaction that this enzyme catalyses, but it marks a milestone in
showing what crowd-sourcing research can achieve, says Nature News. More information about this research is available at: www.nature.com/news/victory-for-crowdsourced-biomolecule-design-1.9872.
(Source: Nature News, 1/22/12) 
NEW FOR 2012
Advertise in the ABC Newsletter and reach key decision makers in blood banking and
transfusion medicine.
Published 46 to 48 times a year, the ABC Newsletter is a weekly chronicle of current events and issues affecting
the blood banking and transfusion medicine communities. Editorial coverage includes regulation, legislation,
litigation, science, technology, and new developments in blood services. Special sections highlight ABC member
news and updates from ABC headquarters. A comprehensive calendar of events is published once a month and
there is a classified advertising section for employment opportunities, equipment, and other notices.
Circulation: approximately 5,000; email only, <0.5% bounce back rate (subscription based)
Frequency: weekly, 46 to 48 issues per year on Fridays (unless Friday is a holiday, then Thursday)
Length and format: Up to 22 pages; portable document format (PDF), portrait layout, 8.5 by 11”
The ABC Newsletter accepts full-page, half-page, third-page, and Marketplace (ninth-page) ads. Reserve early
to guarantee space (ad space is limited). For rates and ad placement forms, download the 2012 Advertising
Opportunities info at http://bit.ly/opps2012 (see p. 9-10 & 13).
ABC Newsletter
-16-
February 3, 2012
LEGISLATIVE NEWS
America’s Blood Centers has signed onto a letter supporting a legislative bill that would free
healthcare providers from liability when they cross state lines to voluntarily provide emergency
assistance in times of disaster. HR 3586, the Good Samaritan Health Professionals Act, was introduced
by US Rep. Cliff Stearns (R-Fla.) in December and now has six cosponsors, including one Democrat,
Rep. Jim Matheson (Utah). “When a disaster strikes, the needs of victims often overwhelm the services
which are available locally,” says the letter to Reps. Stearns and Matheson, signed by several organizations, including the American Medical Association, who are members of the Health Coalition on Liability
and Access. “It is in such times that we see the true spirit of America reflected in the volunteers who rush
to the region in the service of others. Unfortunately, as you are well aware, the Volunteer Protection Act,
which was enacted specifically to encourage such actions, failed to address the issue of healthcare providers who cross state lines to aid disaster victims. Your legislation is greatly needed to address this
oversight and ensure that health professionals who wish to provide voluntary care in response to a disaster
are able to do so and not face uncertainty about potential liability.” The only exceptions to the protection
would involve acts of gross misconduct or negligence or if the healthcare provider was under the influence of a drug or alcohol at the time that care was given.
The House reauthorization season for laws that provide the Food and Drug Administration with
resources for getting new medicines to the market kicked off on Tuesday. A Health Subcommittee
hearing focused on the Prescription Drug User Fee Act (PDUFA) and two pediatric drug laws due to expire at the end of September. FDA Commissioner Margaret Hamburg, MD, testified about a new fiveyear PDUFA agreement worked out with the drug industry. Under the new pact, FDA will implement a
new 60-day validation period to communicate and plan with drug sponsors before its review clock officially starts. It also promises to review “priority drugs” in six months vs. the 10 months it normally takes
for standard drugs. For its part, the industry will pay more than $712 million in FY2013 and increasing
amounts during the remaining four years of the authorization period. According to Dr. Hamburg, FDA
approved 35 new drugs in fiscal year 2011, all but one meeting their target dates, which she said is close
to a record since PDUFA was first enacted in 1992. The agency has also reduced approval times from an
average of two years when PDUFA began to about 1.1 years, which is faster than the agency’s counterparts in the European Union. “Our user fee system has become the gold standard around the world,” she
said. Republicans on the panel, a subcommittee of the Energy and Commerce Committee, pushed for
quicker, more predictable review times and a “level playing field” with foreign competitors. They also
expressed concerns about what they say are too-stringent conflict-of-interest rules for advisory committee
members [in October, Health panel members introduced a bill that would make it easier for experts to
serve on advisory committees]. Democrats, on the other hand, discussed the need to balance risks to drug
safety from a lack of regulatory oversight with the potential benefits to patients from innovative new therapies. They want to increase oversight of the drug supply chain and step up inspections of foreign drug
makers and component suppliers, particularly in China. Foreign-made drugs, mostly generic drugs, comprise about 40 percent of the US market. They also discussed the need for an electronic “track and trace”
pedigree system for generic drugs. Dr. Hamburg said the FDA is increasing overseas inspections and
forging new partnerships with its foreign counterparts who already inspect. The only bit of drama came
when Rep. Michael Burgess (R-Texas) pointedly asked Dr. Hamburg why the FDA’s Office of Legislative Counsel had failed to provide requested documents to House investigators looking into the
contamination of the blood thinner Heparin, which caused 81 deaths in the US. She said she thought documents had been provided but promised to look into it. The panel also discussed reauthorization plans for
the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. On Feb. 7, the panel
will hold a hearing on the Generic User Fee Act and the Biosimilar User Fee Act reauthorization; on Feb.
15, it will take up the Medical Device User Fee Act reauthorization.
– Robert Kapler, [email protected] 
ABC Newsletter
-17-
February 3, 2012
REGULATORY NEWS
The Food and Drug Administration is currently facing a lawsuit for secretly monitoring the personal e-mails of a group of its own scientists and doctors who warned Congress that FDA was
approving medical devices that they believed did not meet safety and efficacy requirements, reported the Washington Post on Jan. 29. Beginning in January 2009, FDA began intercepting e-mails
from the personal e-mail accounts of nine scientists and doctors who were communicating with Congress
to create whistleblower complaints against FDA. The agency also took electronic screenshots of the desktops of these FDA staffers and reviewed documents saved in their hard drives. All of these employees
worked for FDA’s Office of Device Evaluation. Only six of the original nine FDA employees sending
these communications joined the lawsuit, and of those six, two were fired, two did not have their contracts
renewed, and two suffered harassment and were passed over for promotions. FDA computers do feature a
warning on the login screen stating that users have “no reasonable expectation of privacy” in any data
passing through or stored in the system, and that the government may intercept any such data at any time
for lawful government purpose. However, the doctors and scientists claim that the government violated
their constitutional privacy rights by viewing their personal e-mail accounts to monitor activity which
they say was legal. FDA alleged to the Department of Health and Human Services in 2010 that the doctors and scientists had revealed confidential business information about the devices, but after a May 2010
investigation, HHS ruled that there was no criminal activity as the doctors and scientists have the legal
right to air concerns to Congress and journalists. Michael Sussmann, former federal prosecutor who is
now a partner at the Perkins Coi law firm, said that FDA’s warning on its computers gave the agency
latitude to conduct extensive monitoring. “The FDA has a huge responsibility to protect public health and
safety,” Sen. Charles E. Grassley (R-Iowa) told the Washington Post. “It’s hard to see how managers
apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress.” (Source: Washington Post, 1/291/12) 
ABC’s Golden Anniversary
Three-Day Celebration Event
ABC is turning 50 and we’re having a ball ... and you’re
invited! Save the date: March 24-26, 2012, Scottsdale, Ariz.,
hosted by Blood Systems, Inc., in connection with ABC’s
Annual Meeting. Online registration is now open! If you did
not receive an e-mail invite with registration information,
please contact [email protected] with the subject
line: “ABC Golden Anniversary Invitation.”
Have a good memory? Been around blood for a while? The Newsletter will
be featuring a series of stories detailing the last 50 years in blood banking.
To contribute your story, e-mail [email protected].
ABC Newsletter
-18-
February 3, 2012
STOPLIGHT: Status of America’s Blood Centers’ Blood Supply
1%
21%
63%
1%
2%
27%
31%
5%
32%
7%
5%
23%
37%
3%
58%
61%
55%
63%
17%
50%
0%
39%
21%
15%
13%
28-Dec
4-Jan
0%
24 %
12%
6%
8%
6%
11-Jan 18-Jan 25-Jan
9%
East
M id w e s t
S ou t h
W est
1-Feb
No Report
Green (3 days or more)
Yellow (2 days)
Red (1 day or less)
Percent of Total ABC Blood Supply Contributed by Each Region
East: 20%; Midwest: 25%; South: 24%
Percent of Regional Inventory at
2 Days Supply or Less, Feb. 1, 2012
Total ABC Red Cell Inventory
Daily Updates are available at:
www.AmericasBlood.org
INFECTIOUS DISEASE UPDATES
PRION DISEASE
A group of researchers in France recently discovered that prion proteins that cause variant CreutzfeldtJakob (vCJD) disease in humans could be lurking undetected in peoples’ spleens, and may be able to
jump species more easily than previously thought, reported Nature News on Sunday. Vincent Béringue, a
prion researcher at the French National Institute for Agricultural Research in Jouy-en-Josas, France, led
the research, which was published on Jan. 27 in Science. Prion diseases are a family of rare progressive
neurodegenerative disorders that affect both humans and animals. Prion protein molecules are normal
components of cells that under certain circumstances fold in abnormal ways, gather in clusters, and precipitate, causing tissue damage and sponge-like holes in the brain. This leads to mental problems, loss of
body function, and eventually death. vCJD, often called “mad cow disease,” affects humans and is always
fatal, while bovine spongiform encephalopathy (BSE) affects cows. Many prion studies have
(continued on page 19)
ABC Newsletter
-19-
February 3, 2012
INFECTIOUS DISEASE UPDATES (continued from page 18)
evaluated the likelihood of cross-species transmission of prion disease by looking for clinical symptoms
and the presence of prions in infected animal brains. However, it is known that prions also replicate in the
lymphoid tissue such as the spleen, tonsils, and appendix. Therefore, the researchers in this study used
mice that had been genetically engineered to express either sheep or human versions of prion disease, and
examined both their brains and lymphoid tissue. When the mice expressing human PrP proteins were
inoculated with BSE prion, only 3 out of the 43 mice had detectable prions in their brains at the end of
their lives. However, 26 of 41 spleens tested positive for prions, even though the mice showed no clinical
symptoms of BSE. This research shows that prions can jump species into lymphoid tissue much more
easily than into the brain tissue, and therefore may show no clinical symptoms. “If you can extrapolate
that to the human situation, you can imagine that there are more people infected subclinically in lymphoid
tissues such as the spleen, who may never develop the disease,” Dr. Béringue told Nature News. Since the
“mad cow” disease scare in the late 1990s, there have been about 200 cases of vCJD reported in the UK.
The study abstract is available at: http://bit.ly/yL3vAx. (Source: Nature News, 1/26/12) 
MEMBER NEWS
Blood Systems has signed an agreement to implement the CaridianBCT Vista Information System
to improve management of its donation process throughout all of its blood centers, announced a
Terumo BCT press release on Jan. 30. CaridianBCT and
Terumo Transfusion are combining to become Terumo
BCT, a transition that will be complete in April 2012. The
Vista system automates donor eligibility evaluation in order to determine which blood components a donor is biologically suited to donate and aligns that donation
with blood center-defined component needs, said the release. This system will be assisting more than 70
Blood Systems donor centers nationwide. “The adoption of the Vista Information System will improve
our operations, improve product availability, and help us to implement new efficiencies in the way we
collect and distribute blood components,” Pat McEvoy, Blood Systems Blood Centers Division president,
said in the release The Vista system will be installed in early 2012, with system-wide implementation to
be completed in early 2013. 
MEETINGS: BPAC Meeting Cancelled
Feb. 29
Blood Products Advisory Committee Meeting.
The Food and Drug Administration’s Blood Products Advisory Committee (BPAC)
meeting, initially scheduled for Feb. 29, and announced in the Federal Register on Jan.
30 has been cancelled. The meeting was set to discuss the evaluation of possible new
plasma products manufactured following storage at room temperature for up to 24 hours.
Also on the agenda were updates on: a report from the Health and Human Services Advisory Committee on Blood Safety and Availability, HHS activities related to the
evaluation of the donor deferral policy for men who have sex with other men, and thrombotic adverse events to immunoglobin products. Also scheduled was a summary of the
public workshop held Nov. 8-9, 2011 on hemoglobin standards and maintaining an adequate blood supply and of the Nov. 29, 2011 public workshop on data and data needs to
advance risk assessment for emergency infectious disease for blood and blood products.
A new date has yet to be scheduled for the next BPAC meeting. 
ABC Newsletter
-20-
February 3, 2012
CLASSIFIED ADVERTISING
Classified advertisements, including notices of positions available and wanted, are published free of charge for a maximum
of three weeks per position per calendar year for ABC institutional members. There are charges for non-members: $139
per placement for ABC Newsletter subscribers and $390 for non-subscribers. Notices ordinarily are limited to 150 words.
To place an ad, contact Leslie Norwood at the ABC office. Phone: (202) 654-2917; fax: (202) 393-5527; e-mail:
[email protected].
POSITIONS AVAILABLE:
Director of Fund Development, The Foundation for
America’s Blood Centers. The Foundation for America’s Blood Centers, a 501(c)(3) public education
organization dedicated to helping ensure a safe and
adequate blood supply, is seeking an experienced fund
development professional to develop and execute the
Foundation’s fundraising goals. For more information,
visit www.theFABC.org. The Director of Fund Development will plan, develop, and execute a comprehensive
fund development program consistent with the Foundation’s mission and programs in order to achieve the
fundraising goals established in collaboration with the
Foundation’s Board of Directors. Responsibilities:
Works directly with the Foundation’s VP of Operations
and Board Chair to develop and implement fund development strategies; manages and coordinates two major
annual fundraising events; develops and executes online,
social media, and text messaging fundraising campaigns;
plans and submits solicitations to corporations and other
foundations; cultivates corporate and individual donors
and acknowledges gifts; manages development assistant.
Qualifications: Bachelor’s degree, five-plus years of
experience in cause-related fundraising with proven
results; skills in online and social media fundraising;
skills in website maintenance preferred; knowledge of
non-profit health agencies and/or blood banking preferred; strong work ethic and interpersonal skills;
excellent written and oral communication and public
speaking skills; excellent organizational skills and the
ability to prioritize; ability to travel, sometimes at short
notice. Job reference and background checks will be
conducted on final candidate(s). To Apply: Download
application form at http://bit.ly/FABC-JA and e-mail
together with resume and cover letter to
[email protected]. Subject Line: FABC DFD. Job
Description: http://bit.ly/FABC-JD. Pay $68,000-70,000
plus generous benefit package. Closing Date: February
10, 2012.
Manager Information Services/Quality Assurance.
Carter BloodCare, the largest independent, communitybased blood program in Texas, is seeking an experienced QA professional. This position provides
leadership in the establishment and maintenance of the
Quality Program and the integration of quality management processes into all aspects of the IS department. The
selected candidate will assist in managing companywide controlled documents using the document management system and will be responsible for compliance
and regulations throughout the department including
validation of all blood banking applications. Medical
Technologist or bachelor’s degree in Quality Programs
required; SBB certification and ISO 9000 Quality System or AABB Quality Program implementation and
maintenance a plus. Five to six years of quality program
management and/or quality auditing or similar experience in the blood banking industry and two to three
years supervisory experience required. Apply on line at
www.carterbloodcare.org.
Director, Regional Quality. Blood Systems, a national
non-profit blood bank is seeking a Director, Regional
Quality for operations in San Francisco, Calif. This
individual will be managing the review of quality systems and compliance in all areas of technical and
clinical operations. This candidate will serve as a resource to operations on quality issues. Bachelor’s degree
and five years of related experience in a regulated industry required. Certification as a Med Tech or SBB is
preferred. CQA, CQE and/or CMQOE certification
within one year required. Three years in a quality, regulatory, and/auditing environment and two years of
supervisory experience is required. Skills in process
analysis, performance improvement, lean or Six Sigma
preferred. For consideration, please submit resume via
e-mail by 02/17/12 to: [email protected] ATTN:
HR/2012/09. We offer a competitive benefits package as
well as relocation and more! Pre-employment drug
testing is required. Visit our website at:
www.bloodsystems.org. EOE M/F/D/V.
Manufacturing Processes Specialist. Blood Systems, a
national leader in the blood banking industry, is recruiting for a Manufacturing Processes Specialist to join our
team. Education/Knowledge: Bachelor’s degree in related area required; and current understanding of federal
and AABB standards governing blood industry manufacturing activities preferred. Licenses/Certifications:
MT (ASCP), RN, SBB, or equivalent certification/licensure required. Experience and Skills: Five
years related experience required; strong working knowledge of SafeTrace System preferred; component
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ABC Newsletter
POSITIONS (continued from page 20)
manufacturing and/or laboratory skills preferred; strong
planning and organizational skills required; ability to
build interpersonal relationships and deliver a high level
of customer service required; and if working remotely,
ability to travel as needed required. Blood Systems
offers a comprehensive benefits package! Preemployment drug testing is required. Visit our website
at: www.bloodsystems.org. EOE M/F/D/V. For consideration, please submit resume via e-mail by 2/3/12 to:
[email protected] ATTN: HR/2012/07.
District Directors. One position located in Huntsville,
Ala. and another position located in Montgomery, Ala.
Both positions responsible for supervising all issues
relating to the operation of the regions and mobile collection units within their respective districts. Some other
responsibilities would include directly overseeing regional managers and personnel, assessing and
monitoring the financial operations and acting as the
community and media spokesperson for LifeSouth within the district. Bachelor’s degree required. A minimum
of five years management experience is strongly preferred as well as industry and/or FDA regulatory
experience. To find out more information about these
positions, please go to www.lifesouth.org.
Quality Assurance Manager (Gainesville, Fla.). Responsible for maintaining a system-wide quality
assurance program that ensures the manufacture and
distribution of safe, pure and potent blood components.
Responsibilities include, but are not limited to: coordinate all operational licensure and accreditation
applications, renewals and modifications; assess the
impact of inspection findings, and internal audit observations on policies and procedures; recommend,
evaluate and monitor overall effectiveness of the quality
system; and prepare interim and annual reports to the
FDA, monitoring changes in component manufacturing,
procedures, equipment and contractors. Bachelor’s
degree required. Experience in blood banking and/or
quality management strongly preferred. To find out
more information about this position, please go to
www.lifesouth.org.
Technical Specialist (Gainesville, Fla.). Responsible
for performing pre-analytic, analytic, and result reporting/releasing procedures in the Immunohematology
Reference Laboratory. This individual may function as a
lead technologist or laboratory supervisor in the Immunohematology Reference Laboratory (IRL), in a
transfusion service or in other laboratories. Bachelor’s
degree in Clinical Laboratory, Chemical or Biological
Science required. Clinical laboratory training and five
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February 3, 2012
years of clinical laboratory experience at a licensed,
certified or accredited facility is also required. Previous
supervisory experience preferred. Master’s degree may
compensate for less experience. Must be SBB certified
by a national accrediting agency. Current Florida license
as a Medical Technologist with pertinent current certification (MT(ASCP), CLS(NCA), MT(AMT), MT(AAB)
and/or NRCC). Supervisor license preferred. To find out
more information about this position, please go to
www.lifesouth.org.
Technical Manager (Mobile, Ala.). Responsible for
managing production through subordinate coordinators
and staff, with full accountability for costs, methods,
personnel, quality, inventory, and distribution. Some
other responsibilities would include: communicating
with all levels of the organization regarding the
processes, issues, risks, and other pertinent information
in order to maintain high standards and to ensure an
adequate and safe blood supply; overseeing departmental equipment validation, repair, replacement, and
acquisition maintaining departmental budget constraints;
and coordinating activities of and provide technical
assistance to other departments of the blood bank and
act as technical liaison to hospitals as needed. Bachelor’s degree in science- related field or equivalent
required. Must be a Medical Technologist (ASCP, SBB
certified strongly preferred, however experience may be
considered equivalent). Relevant experience in transfusion services and/or laboratory blood banking required.
To find out more information about this position, please
go to www.lifesouth.org.
Medical Director (Gainesville, Fla.). To join medical
group responsible for providing medical direction for all
donor-related activities, laboratory, and cellular therapy
activities and employee health issues in all of our centers based in Alabama, Georgia, and Florida. Medical
Director will be expected to focus primarily on developing and directing patient-related activities including
overseeing therapeutic apheresis services in one or more
LifeSouth regions and advising patients and their ordering physicians about indications for appropriate patient
blood management. MD, MD/PhD. or D.O. degree with
board certification in a primary specialty (pathology,
pediatrics, internal medicine, etc.) required. Must be
board certified or eligible in blood banking/transfusion
medicine, preferably in both hospital and blood center
settings. To find out more information about this position, please go to www.lifesouth.org.