Download Studies Suggest Tainted Samples, Reagents in XMRV Research

2011 #1
INSIDE:
Our Space:Hemovigilance:
From Skeptic to Fan .....2
The ABC Newsletter’s Top
Stories of 2010 ................3
Hopes and Predictions for
2011 ...............................9
Tale of the Macabre:
Saddam had Quran
Written in His Own Blood
...................................12
Chicago Zoo Creating First
Blood Registry for Apes
...................................13
Webinar on Data
Warehouse Next Week
for ABC Members.......15
New Year Heralds
National Blood Donor
Month .........................15
Earlier 2010 Study
Suggests Transfusion
May Be Just a ‘Marker’
for NEC.......................20
January 7, 2011
Scientists See Transfusion’s Role in Reaction in Gut as ‘TRAGI’
The authors of a new study suggest that a severe neonatal gastrointestinal reaction
after the transfusion of red blood cells (RBCs) for anemia should be called “transfusion-related acute gut injury (TRAGI).”
The study’s findings, on which the assertion is based, do not corroborate a similar
study in the same journal several months earlier but do support earlier research
that found an association between RBC transfusion in very low birth weight
(VLBW) neonates and necrotizing entercolitis (NEC).
Study Posits that Transfusion May Be Only a ‘Marker’ for NEC, page 20
NEC is a condition characterized by the infection, inflammation, and/or destruction of all or part of the intestine, usually affecting tiny premature or sick infants.
NEC occurs in approximately 10 percent of VLBW babies and is associated with
several etiologic mechanisms, including ischemia (decreased blood supply to organ or tissue), infection, mechanical injury, and iatrogenic factors (resulting from
the activity of physicians), but there has been no consensus as to a cause.
The authors of this study, led by Jonathan Blau, MD, hypothesize that transfusionassociated NEC is in several ways similar to transfusion-related acute lung injury
(TRALI) and thus many of the same transfusion-related immunologic mechanisms
might be at work in the intestine as in the lung.
(continued on page 22)
Studies Suggest Tainted Samples, Reagents in XMRV Research
Four studies published last month in the journal Retrovirology assert that contamination of blood samples and assays by mouse DNA may be the source of
xenotropic murine leukemia virus-related virus (XMRV) thought to be found in
the blood of patients with chronic fatigue syndrome (CFS) and prostate cancer.
Early versions of the studies were published online on Dec. 20, six days after the
Food and Drug Administration’s Blood Products Advisory Committee recommended that blood donors with a history or a diagnosis of CFS be deferred
indefinitely (see ABC Newsletter, 12/17/10). The panel’s 9-4 vote reflects concerns that XMRV may be linked to CFS and transmitted by blood transfusion.
(continued on page 24)
ABC Newsletter
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January 7, 2011
OUR SPACE
By ABC CEO Jim MacPherson
Hemovigilance: From Skeptic to Fan
Those who know me know I have treated the march to a comprehensive hemovigilance program with some
skepticism. Two major factors drove this view: First, many large hospitals with active transfusion monitoring
programs and transfusion committees have questioned what more they might learn. Second, although Food
and Drug Administration death-from-transfusion data is likely the “tip of the iceberg,” it has proven a reliable
gauge to know which way adverse reactions were going. I, and many others, concluded that unless hemovigilance meant changes in hospital monitoring systems themselves, not much new would be learned.
The basis for a more in-depth review of transfusions is both data from the intensive UK monitoring program
SHOT, which uncovered transfusion-related acute lung injury as a major unnoticed cause of transfusion
deaths, and from the “original” (also intensive) hemovigilance program in France, which found excessive
deaths among older surgical patients likely due to anemia from under-transfusion.
Not to brag, but the possibilities of deep monitoring using ABC’s Appropriate Inventory Management (AIM)
clinical monitoring Module 2 are pretty astounding. Here is a program that, in addition to benchmarking and
forecasting blood use, can trace an individual donation and all its attributes (like age at hospital receipt and
transfusion, leukoreduction, irradiation, etc.) to a recipient with objective outcomes, such as infections or reactions, length of stay, discharge diagnosis, and readmissions within a 30-day period. Does fresh blood matter?
AIM may be able to help answer questions like this. AIM also looks at all admitted patients as a control group.
Do patients with nearly identical diagnoses and procedures fare better or worse with or without transfusions?
It’s all part of AIM.
AIM also makes “Phase 4” trials possible, opening the possibility, as with drugs, of quicker approvals of
“new” blood products (like those subjected to pathogen reduction technology) because of real-time monitoring
of the results of transfusions with this business intelligence software.
We are on the cusp of a new era that will show where transfusions add value and where they don’t. It’s pretty
exciting.
[email protected] 6
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ABC Newsletter
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January 7, 2011
The ABC Newsletter’s Top Stories of 2010
Many of the business trends and blood safety issues that occupied blood bankers in 2009 were back in
2010. There were new partnerships, mergers, and layoffs; continued debates about the severity of and
proper responses to emerging pathogens such as dengue; as well as the real or imagined threats that gay
men might pose to the blood supply. Some closure did come to blood centers girding themselves for the
possibility that a mild H1N1 pandemic might turn virulent and far-reaching. To everyone’s relief, the
blood community escaped that worst-case scenario. Here are the editors’ picks for the top stories of the
year.
No. 1: Merger Mania
As the US economy wobbled toward a jobless recovery and the healthcare community faced congressionally
mandated reforms in 2010, blood centers and the hospitals they serve began to rethink their game plans. Some
hospital chains started treating blood as a commodity and began demanding system-wide bids on blood products. In this pressure-cooker climate, blood centers looked to layoffs, mergers, and joint ventures as a way to
stay viable.
Mississippi Valley Regional Blood Center merged with Central Illinois Community Blood Center and ditto for
The Blood Center of Iowa and Siouxland Community Blood Bank (now known as LifeServe Blood Center).
Meanwhile, United Blood Services (UBS) transferred two blood center operations in Arkansas – a donor center in Fort Smith and a center in Hot Springs – to Oklahoma Blood Institute, and UBS’ Texarkana, Texas,
satellite center became part of LifeShare Blood Centers, based in Shreveport, La.
UBS’ parent, Blood Systems, formed a laboratory venture with Florida Blood Services (FBS) in and later
announced that it was talking about a possible business venture with the Institute for Transfusion Medicine.
But the biggest news of the year had to be the announcement several weeks ago that the three largest blood
centers in the Sunshine State – Florida Blood Services, Florida’s Blood Centers, and Community Blood Centers of Florida– had entered into merger talks. If that eventually happens, the combined entity would be a
behemoth – drawing 80 percent of the blood in Florida and potentially becoming ABC’s largest member.
No. 2: A Research Ping-Pong Match Featuring XMRV and CFS
Last year’s ongoing controversy about a possible link between xenotropic murine leukemia virus-related virus
(XMRV) and chronic fatigue syndrome (CFS) actually began in October 2009, when a team of scientists led
by Judy Mikovits, PhD, of the Whittemore Peterson Institute for Neuro-Immune Disease reported in Science
that they had found evidence of the retrovirus far more often in people diagnosed with CFS than in healthy
control subjects.
That led to a wave of studies attempting to confirm the findings, with varying results. A number of research
teams from the UK and other countries had reported in scientific journals that they were unable to find XMRV
in patients with CFS. But more studies were in the offing. Among them:
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In August, a research team from the Food and Drug Administration and the National Institutes of
Health found a strong association between CFS and a diverse group of murine leukemia virus (MLV)related viruses, and it detected MLV-like viral sequences in 6.8 percent of 44 healthy blood donors
tested. However, the study’s publication in Proceedings of the National Academy of Sciences (PNAS)
was delayed when scientists from the Centers of Disease Control and Prevention completed a study in
which they did not find XMRV in the blood of people with CFS. The s results of that study were published on July 1, with the PNAS study following in August.
(continued on page 4)
ABC Newsletter
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January 7, 2011
Top Ten Stories of 2010 (continued from page 3)
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In October, one US and one European research team reported finding no XMRV in patients with CFS
or a number of other diseases or conditions. But one US study found it in more prostate cancer patients than healthy control patients.
Then in December, four studies appeared in Retrovirology, asserting that contamination of blood
samples and assays – rather than human infection – may be causing false positive results for XMRV
(see related story, page 1).
This ping-pong match of results led to a good deal of head scratching by members of the blood community,
particularly because the possible association of XMRV and CFS raises the question of whether XMRV might
be transmitted through transfusions. Although no studies have shown that, and although none have shown that
XMRV causes CFS, in June AABB recommended that blood collectors distribute CFS education materials to
“discourage” potential donors diagnosed with CFS from giving blood.
Since then, a number of other countries have banned people with CFS from donating blood, and in early December the American Red Cross decided to do the same, announcing that it was beginning to indefinitely defer
donors who reveal a history of CFS. A week later, FDA’s Blood Products Advisory Committee recommended
that a question about CFS be added to the donor history questionnaire, and that a history of or a diagnosis of
CFS should be grounds for an indefinite deferral.
No. 3: FDA Brings Closure to Several Major Regs
FDA played a game of regulatory catch-up in 2010. In April, the agency issued a final guidance on nucleic
acid testing (NAT) for HIV-1 and hepatitis, putting the finishing touches on a draft that was published way
back in 2005. The guidance provided recommendations on testing, product disposition, and management of
donors with positive test results on NAT for HIV-1 and hepatitis C virus.
The same month, the agency issued a guidance for reentry of blood donors
deferred because of repeatedly reactive results to testing for antibodies to
hepatitis B core antigen (anti-HBc) that were falsely positive. The draft
guidance was issued in May 2008.
Call this next one half a loaf: In December, some 20 months after the Blood
Products Advisory Committee recommended selective testing for Chagas disease, FDA issued a final guidance
on performing selective serological testing on donated blood to detect antibodies to Trypanosoma cruzi, the
etiologic agent.
The guidance recommends one-time donor testing of plasma and serum samples from individual human donors. The guidance document does not apply to the collection of source plasma or to eligibility determinations
for donors of human cells, tissues, or cellular and tissue-based products. Those two will get their own guidances in the future. This guidance retains a requirement for a question about having had Chagas disease and
also recommends quarantine and retrieval of past collections from donors with repeatedly reactive results.
No. 4: Healthcare Reform Law Draws Scrutiny and Questions
Though the details are far from being worked out, the first outlines of the healthcare reform law began to
emerge last year, as did a blowback of sorts on some of the provisions. While ABC went on record in 2009 as
opposing a $20 billion excise tax that will be levied on the manufacturers of medical devices, last year the
(continued on page 5)
ABC Newsletter
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January 7, 2011
Top Ten Stories of 2010 (continued from page 4)
organization urged its members to take up the fight to repeal the 1099 tax document provision contained in
Section 9006 of the Patient Protection and Affordable Care Act.
This provision, which is expected to generate $19 billion in revenue, mandates that, beginning in 2012, both
nonprofit and for-profit companies must issue 1099 tax forms, not just to contract workers, but to any individual or corporation from which they buy more than $600 in goods or services in a tax year.
Blood centers are already being asked to save little flimsy paper receipts for gasoline in order to seek an exemption from excise taxes on fuel, which could just as easily be handled on the
front end with a credit card that automatically deducts the taxes. Now they are
being asked to issue a 1099 form to every business that bills them for more than
$600? What happened to the paperless society?
Last fall, the Senate failed twice to do away with the controversial 1099 provision
by being unable to muster the 67 senators needed for a two-thirds majority to
move forward with consideration.
On another front, blood centers struggled to figure out where they fit into a plan
to promote accountable care organizations (ACOs). The Centers for Medicare and
Medicaid Services’ Shared Savings Program (SSP) model of delivery and payment reform involves alliances
of healthcare providers – ACOs – that work in tandem to cut costs and use benchmarking to improve patient
outcomes. The model allows participants to share in any savings created. That is a departure from the current
healthcare system, in which reimbursement payments increase when providers promote more health services.
The SSP is to commence no later than Jan. 1, 2012. The question for blood centers is the same for most other
hospital suppliers – where do we fit in?
No. 5: An Attempted Legislative Crackdown on Blood Centers in Florida
A zealous Florida state senator used zealous news articles about Florida’s Blood Centers (FBC) as a springboard for pushing a legislative bill that, if enacted, would have drastically increased state oversight of all
blood centers in the Sunshine State.
A series of Orlando Sentinel newspaper articles posed pointed questions about business practices among FBC
board members and top brass. The initial articles led to an investigation by a committee chaired by Sen. Don
Gaetz (R-Dist 4). Questionnaires were mailed to all blood centers in the state asking about pricing and business policies, and then the committee held a high-profile hearing. Though then-FBC CEO Anne Chinoda
testified that reforms were underway at her blood center, subsequent articles questioned Ms. Chinoda’s salary
hike at a time when her employees were being laid off. Ms. Chinoda ended up resigning from the blood center
and Sen. Gaetz went ahead with his bill.
S 1818 would have required blood centers to post tax returns for the preceding three years on their websites;
describe all steps taken to collect, process, and test blood; tell how much blood is imported; give the price and
number of units supplied to healthcare providers; and outline blood center policies for determining CEO compensation and board governance. Failure to comply would have resulted in a fine of up to $10,000.
The measure was defeated in the House after lobbyists for the Florida Association of Blood Banks won the
support of Speaker Larry Cretul (R-Ocala), a longtime blood center champion. But Sen. Gaetz vowed to reintroduce the bill sometime after the next legislature begins in March. Word from Florida is that a new bill has
already been drafted.
(continued on page 6)
ABC Newsletter
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January 7, 2011
Top Ten Stories of 2010 (continued from page 5)
No. 6: Red Blood Cell Storage and Patient Outcomes – A Two-Year Debate
Do patients who need transfusions do better if they receive “fresher” blood? That has been a key question at
least since 2008, and last year saw a few new arguments in the debate and the launch of a number of studies
that will provide more evidence to help resolve the question.
The effect of storage time on the safety and efficacy of red blood cells (RBCs) was
brought to center stage by the 2008 publication of a study by Cleveland Clinic researchers led by Colleen Gorman Koch, MD, in The New England Journal of
Medicine. Dr. Koch’s team analyzed the outcomes of 6,000 cardiac surgery patients,
finding that those who received blood more than two weeks old experienced greater
complications and a 50 percent higher death rate than those who got fresher blood.
But more recent studies, rather than corroborating those findings, have provided
mixed results. For example, in February, Transfusion published the results of a study
funded by the National Heart, Lung, and Blood Institute (NHLBI). Its authors found
the seven-day risk of death to be similar for all patients, regardless of the age of the
blood they received. However, two-year mortality among patients receiving RBC
concentrates stored for 30-42 days was about 5 percent higher than among recipients of blood stored for 10-19
days.
However, in June, Transfusion published the results of a study that found that substances released from nonleukoreduced RBCs during storage have an effect on platelets and inhibit their ability to aggregate and become
part of a clot. Its authors recommended that trauma patients receive RBCs that were less than 14 days old.
To help address such competing findings, the NHLBI announced last summer that it is funding nine research
grants to determine if the safety and efficacy of RBC transfusions are influenced by storage time. The Red
Cell Storage Duration Study, or RECESS, is the first large, multi-center, randomized clinical trial to compare
outcomes in heart surgery patients who receive RBCs stored for shorter or longer periods of time. The study
plans to randomize about 1,800 cardiac surgery patients at an estimated 15 centers across the US. Eight other
research teams will use animal models and physiologic studies to learn more about storage lesion and what
changes RBCs undergo while they are stored, as well as whether those changes affect the blood vessels and
tissues once transfused.
No. 7: Gay Men Who Want to Donate Blood Still MSMs to FDA
For a while last year, it seemed like the Food and Drug Administration might revise
its long-standing policy of permanently deferring any male donor who has had sex
with another man (MSM), even once, since 1977. Through the spring and early
summer, a growing chorus of voices – which included a number of US senators and
representatives, as well as America’s Blood Centers, AABB, and the American Red
Cross – called for a revision to the policy.
Proponents for revision say the deferral period for MSM is inconsistent with deferral periods for other high-risk behaviors. They also point to the effectiveness of
current methods of screening blood for HIV and other sexually transmitted diseases.
But in June, the Department of Health and Human Services’ Advisory Committee
on Blood Safety and Availability (ACBSA) decided against changing to a shorter deferral period. The main
concern was that the
(continued on page 7)
ABC Newsletter
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January 7, 2011
Top Ten Stories of 2010 (continued from page 6)
change might raise the risk of transfusion-related HIV infections. The next month, though, Transfusion published the results of an Australian study which its authors called the first internationally published research
report to assess the impact of adopting a 12-month MSM deferral. They found no evidence that changing from
a longer deferral period to this shorter one increased the risk that donated blood or blood products would be
infected with HIV. They also found that donors’ compliance with deferral policies seems to be more important
to blood safety than the length of the deferrals.
In fact, ACBSA had acknowledged that possibility in June, and it recommended that FDA address problems
with the current donor screening process, as well as the fact that units of blood are on rare occasions released
inappropriately through quarantine release errors.
The MSM deferral question was also reflected in the Canadian courts: Canadian Blood Services (CBS) spent
months this summer and fall dealing with a lawsuit from a gay man who had donated blood a number of times
after incorrectly answering the question about MSM. He charged that the policy discriminates unfairly. But in
September, a judge in the Ontario Superior Court ruled that CBS’ MSM deferral is based on high standards for
safety and does not violate the rights of gay men. However, she did indicate that, based on the testimony she
heard, the length of deferral appears to be excessive.
No. 8: Support Builds for Appropriate Inventory Management
Last year, more blood centers seemed to “see the light” – the illumination of all the data that a hospital can
now obtain to control blood inventory, and thus costs. In 2010, ABC’s Appropriate Inventory Management
(AIM) system signed up its 20th blood center.
AIM is based on software developed by the UK’s National Health Services
Blood and Transplant (NHSBT). In eight years of use, NHSBT led to a 16
percent decrease in red blood cells distributed, a 45 percent reduction in
wastage, and an average five-day increase in the freshness of red blood cells
distributed.
Joining such heavyweights as Carter BloodCare, Florida Blood Services, and
BloodCenter of Wisconsin, Coastal Bend Blood Center, located in Corpus
Christi, Texas, purchased AIM Module 1, becoming the 20th blood center to
“take AIM.” In November, ABC also rolled out AIM Module 2. The new
module enables blood centers and their hospital clients to access automated
data reports on blood inventory and utilization, as well as patient outcomes stratified by blood product, indication, and patient population.
No. 9: Octapharma Weathers a Rough Year
Octapharma, a respected company in the plasma therapeutics industry, suffered a major headache last year.
One of its signature immune globulin intravenous (IVIG) products – Octagam – had to be pulled off the market in both the US and the European Union. Though an investigation continues at this writing, it seems that an
unexpected rise in thromboembolic reactions among patients taking Octagam began a couple of years ago.
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use said the increase
in reactions could be related “to the presence of impurities which could act as clotting/coagulation factors in
the product [that were] introduced during the manufacturing process.”
(continued on page 8)
ABC Newsletter
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January 7, 2011
Top Ten Stories of 2010 (continued from page 7)
This is a head-scratcher considering that Octagam Immune Globulin Intravenous (Human) 5% received approval from the US Food and Drug Administration in May 2004 for the treatment of primary
immunodeficiency diseases after being on the
market in Europe for 10 years.
A European report was inconclusive, though
it did mention that the company had slightly
altered one phase of its manufacturing process a few years ago.
The news preceded the announcement that Octapharma would terminate its global and regional memberships
in the Plasma Protein Therapeutics Association and of the resignation of Kim Björnstrup, vice chair of the
Octapharma Group, who was associated with Octagam.
Through it all, the company seemed to go out of its way to keep its hospital customers and their patients informed of the problem and to cooperate with FDA and EMA authorities. Officials no doubt are hoping that
2011 brings a resolution to all concerned, that Octagam gets back on the market, and that Octapharma’s flag
flies high once again.
No. 10: Another Fine for the American Red Cross
In June 2010, the Food and Drug Administration fined the American Red Cross (ARC) $16.18 million, including $9.78 million for mismanagement of blood products and $6.39 million for good manufacturing practice
violations. FDA had informed ARC of the failures in October 2009, in an adverse determination letter that
referred to hundreds of violations found between February and November of 2008.
The fine and letter were used as ammunition in labor negotiations. The AFL-CIO
had urged its unionized members, a few months before the fine was issued, to
consider boycotting Red Cross blood centers in favor of “alternative blood drive
operators.” According to an AFL-CIO executive council statement, staff reductions at some ARC blood centers caused not only labor disputes but also blood
safety problems. Some employees said they had been working without a contract
for more than a year. Eight unions spread across at least half a dozen states filed
notices that they intended to strike. Though the Red Cross said that strike threats
were merely ongoing tactics to bring the organization to the bargaining table, as
many as 1,200 employees did go on strike briefly, causing the cancellation of a
number of scheduled blood drives and halting blood collections at some centers.
Still, hope springs eternal. The organization points out in a report found on its website that between July 2006
and March 2010 it enjoyed a 47 percent reduction in overall blood problems, a 70 percent reduction in laboratory testing issues, a 52 percent reduction in recalls, and a 79 percent reduction in blood collection time and
documentation issues. (Editor’s note: It should be mentioned that independent blood centers receive their fair
share of 483s and that a few have operated under consent decrees in the past.)
And FDA, in its latest letter, said it was “encouraged by recent efforts by the Red Cross leadership” and noted
that since 2003, the organization “has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories, and increasing oversight of the organization.”
Then again, since 2003 the agency has also sent 12 critical letters to the Red Cross and imposed more than $21
million in fines. 6
ABC Newsletter
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January 7, 2011
Hopes and Predictions for 2011
The editors asked a handful of officials from America’s Blood Centers and a few of the organization’s
close friends to give their New Year’s prognostications and wish lists for the blood community and the
rest of the nation. Here are their responses:
Tom Schallert, president, America’s Blood Centers
I have never been a soothsayer so I have no predictions for 2011, but I do have a wish for the New Year: Having had the privilege and honor for the last two years to be president of America’s Blood Centers, I have seen
that throughout the so-called “developed world” we have the safest blood supply available for patients we
serve and, generally speaking, it is also an adequate supply.
However, there is also the stark and rather grim reality that, in much of the developing world, patients die
every day because there is not enough blood or because the blood that patients receive is not safe.
My wish for 2011 is that blood centers, regulators, and vendors in the developed world find ways to work with
international organizations such as Rotary International (to mention just one) to improve the adequacy, safety,
and quality of the blood supply for patients everywhere. No single organization can do it all, but all of us can
do something to help these countries achieve their own goals of a safe and adequate supply of blood for their
patients.
Happy New Year to all.
Jim MacPherson, chief executive officer, America’s Blood Centers
Given the challenges that faced us in 2009 and 2010, my heartiest wishes for 2011 are for measures that will
make life easier for the blood community:
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First and foremost, I hope for widespread adoption of ABC’s Appropriate Inventory Management
(AIM) system. As more and more ABC centers offer AIM to their hospital partners, its potential uses
and benefits in transfusion medicine are limitless. As the first national database in the world to offer
vein-to-vein data, it offers a remarkable spectrum of information about who gets blood and who
doesn’t and why, as well as patient outcomes.
I hope clearer answers emerge about the role of blood centers as healthcare reform provisions are put
into place. Crucial aspects of this include our role in accountable care organizations and our eligibility
for funding for health information technology advancements. While ABC works nationally on this,
I’ve talked with scores of members who are working locally and regionally to support hospitals’ twin
goals to raise the quality of patient care while lowering costs. We’ll work locally and nationally together to connect that loop.
I also hope US blood regulators will agree on some standards – in other words, some harmonization –
that would allow them to more easily accept the results of studies carried out in other parts of the developed world. That would vastly reduce how much money companies have to invest to bring new
products to market – which could result in major advances in blood safety. It is a national disgrace
that we have no state-of-the-art tests for emerging pathogens purely because of regulatory burdens.
Finally, it looks as if 2011 will bring some improvement in the economic conditions that have brought
such challenges to so many of our members and the hospitals (and patients) they serve. When things
do pick up, we need to remember the lessons learned in these difficult times; that is, how important it
is to be as efficient as possible, and how much we benefit when we work together.
Happy New Year, everyone!
(continued on page 10)
ABC Newsletter
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January 7, 2011
Hopes and Predictions (continued from page 9)
Celso Bianco, MD, executive vice president, America’s Blood Centers
I hate to make predictions! I am right 50 percent of the time and wrong 50 percent of the time, exactly what
you would get by tossing a coin. However, I will stick my neck out and take the risk.
First, I believe that ABC members will have a better year and consequently ABC will have a better year. Many
of the uncertainties we are dealing with will either resolve themselves or will be addressed by all of us.
However, while our blood supply has been plentiful, it may be threatened by managerial adjustment of our
collection activities (i.e., intentionally collecting less blood because of fewer hospital clients) and by new
blood donor deferrals (e.g., changes in minimum levels of hemoglobin or donation intervals, deferrals for
areas with dengue activity, etc.).
Some of these changes may affect selected segments of our donor population. For instance, African Americans
normally have lower levels of hemoglobin; fewer donations from them will certainly affect the availability of
rare blood types for sickle cell patients. The introduction of geographic deferrals for dengue would add an
entire, almost unpredictable dimension to the current malaria deferrals. Differently from malaria, dengue epidemics occur in major cities in Latin America and in Asia that are frequent destinations of business travelers
and tourists.
The blood supply will not be threatened by new screening tests being added to the donor eligibility menu in
2011. Assay manufacturers have shown diminished interest in blood donor screening assays because blood
collections are a mature market and selective testing approaches developed to reduce costs (e.g., first time
donors for antibodies for T. cruzi and restricted geographical areas for Babesia) reduced the population that
would require screening, making recovery of the investment in development and regulatory clearance less
attractive than before.
Finally, it is our hope that the healthcare system will balance itself in order to provide the necessary resources
required for the safety and availability of the US blood supply, if not in 2011, in the foreseeable future. It
would be terrible if a tragedy or a crisis were needed to trigger the required changes.
William Coenen, chief operating officer, America’s Blood Centers
I normally don’t like to make predictions (except for the ones I have some control over), but here goes:
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2011 will be another good year for the stock market.
Employment will increase, leading to more consumer spending.
There will be more alliances/consolidations among blood centers, not necessarily because of
healthcare reform, but because of the need for access to new technology, such as blood vending
machines in hospitals.
I personally will earn less, since I will be working less.
Mr. Coenen, a longtime blood banker and ABC official, will change his status at ABC to part time on April 1.
Leslie Botos, chair, ABC Government Affairs Committee
2010 was the year we responded to demands for cheap, cheaper, and cheapest. We let others convince us that
what we do is nothing more than managing commodities. We allowed ourselves to call blood “a drug.” Let us
welcome 2011 as the year we remember the wonder and privilege of doing what we do.
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ABC Newsletter
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January 7, 2011
Hopes and Predictions (continued from page 10)
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Let’s remember the people – patients and their families and friends - who allow us into their lives
because they depend on the precious gift of blood given by people who care about one another,
their community, state, and nation.
Let’s make our voices heard by those we elect to local, state, and federal offices. Let’s mobilize
our donors to speak for us in a voice that is heard from Sacramento to Washington, DC and from
our southern to our northern borders.
Let’s make 2011 the year we remember why we do what we do, the importance of it all, and learn
to be better than ever.
From the gift of blood given by generous donors, we create what the FDA defines as a drug. We run our businesses responsibly, we do good science, we follow the rules, we treat people as we wish to be treated, and we
defend what we do as valuable, responsible, important, and precious.
In 2011, let’s not marginalize the value of the gift, the people who give, or the work that we do. Happy New
Year!
Ms. Botos is vice president of Public Affairs at BloodSource in Mather, Calif.
Lauren Larsen, president, Foundation for America’s Blood Centers
My wishes for 2011:
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Broaden the grants program of the Foundation for America’s Blood Centers (FABC) to support
ABC members who are doing good-works projects in developing countries;
Sell out the house at the “No Laughing Matter Comedy Tour” pilot on April 9 (and raise a lot of
dough);
Sell out the house at the “Saving Grace: A Night of Hope and Gratitude” gala benefit on Nov. 12
(and raise a lot of dough);
Launch FABC’s own website in order to – you got it – raise a lot of dough; and
If it’s not too much to ask: win the lotto, lose 10 pounds, and experience peace on Earth.
Louis M. Katz, MD, chair, AABB Transfusion Transmitted Diseases Committee
(Disclaimer: If I were able to predict the future, does anyone think that I would remain a blood banker?)
Swami Katz’ predictions for 2011 (in order of certainty):
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I will be another year older when 2012 comes.
Lots of blood will continue to be available in the US.
The year will pass with no consensus about the role of XMRV (or related mouse leukemia-like viruses) in the pathogenesis of any nosologic entity.
The ascending epidemic curve of dengue virus infections worldwide will complicate our efforts to
rationalize deferral of donors for travel to large areas of the world where malaria control efforts
have been effective.
The St. Louis Cardinals will win the World Series.
Among other posts and affiliations, Dr. Katz is executive vice president, Medical Affairs, at Mississippi Valley
Regional Blood Center; a member of the Blood XMRV Scientific Research Working Group; and a former
president of ABC.
(continued on page 12)
ABC Newsletter
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January 7, 2011
Hopes and Predictions (continued from page 11)
Ruth Sylvester, director, Regulatory Affairs, America’s Blood Centers
I don’t predict, it’s kind of like assume, and you know what happens when you assume. However, I will offer
my wish list.
From a regulatory perspective I believe our membership would be well served if the Food and Drug Administration could release two final guidances, one approving the use of the Abbreviated Uniform Donor History
Questionnaire and one recognizing concurrent plasma (that is, plasma collected by apheresis at the same time
as platelets or red blood cells) as a licensable product.
Lastly, I would love to be part of a collaborative approach with the FDA to improve submission turn-around
times. 6
Tale of the Macabre: Saddam had Quran Written in His Own Blood
Before he lost power and was executed, Iraq President Saddam Hussein, the “Butcher of Baghdad,” had
his own blood used as ink for a long-hand version of the Quran, the Islamic religious text that Muslims
believe is the moral handbook and final revelation of God.
Saddam Hussein Abd al-Majid al-Tikriti, who led Iraq from July 1979 until April 2003, conscripted a
calligrapher to copy the Quran in his blood sometime in the late 1990s, according to an article in The
Guardian (UK) published on Dec. 19.
In a gesture of “gratitude” to God, President Hussein reportedly donated 7 gallons (27 liters) of blood
over the course of two years to be used as ink in the macabre volume. As with any book, the number of
pages depends on the size of the font and page, but one version of the Quran has more than 600 pages
covering the 114 chapters, or suras, of text.
“Blood is a common medium used in paint,” Bruno Pouliot, a conservator at
the Winterthur Museum in Delaware and a professor of art conservation at the
University of Delaware, told LiveScience magazine. “Ox blood is one of the
oldest forms, and a very stable form, actually, of paint.”
Human hair and even human skin show up in art throughout the ages, Mr.
Pouliot said, but human blood is more of a rarity. Mr. Pouliot attributed the
relative lack of blood-containing artwork to cultural taboos “related to actual
risks involved in using these materials,” he said.
Those risks include blood-borne diseases such as hepatitis B and HIV, said
Celso Bianco, MD, executive vice president of America’s Blood Centers. President Hussein’s
calligrapher would have been at some risk of contracting a disease from fresh blood, Dr. Bianco said, but
that concern is long gone. “The pathogens that can be carried by blood are many,” Dr. Bianco told
LiveScience. “But in general, when it’s dried in the form of the written word, it would not be infectious.”
Perhaps the biggest health risk was to Mr. Hussein himself, whose 27-liter blood donations over two
years would have been roughly five times the amount of blood in his body at any given time, Dr. Bianco
(continued on page 13)
ABC Newsletter
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January 7, 2011
Blood Quran (continued from page 12)
said. The amount of blood a donor is allowed to give in the US is five or six pints over the course of a
year, or less than a gallon. At that rate, it should have taken Mr. Hussein nine years to donate all that
blood, not two. “It’s an incredible amount, if that [number] is correct,” Dr. Bianco said. “That certainly
would have made him anemic.”
The blood Quran is now kept behind locked doors in a mosque in Baghdad, and officials are uncertain
how to handle an object that is simultaneously sacred and profane. “What’s different about things that
involve human remains is that they are always controversial,” University of Delaware professor of art
conservation Vicki Cassman, PhD, told LiveScience. In the case of the Quran, Dr. Cassman said, “there is
that symbolism – that is, who it represents and if this person’s spirit lives on in the object.”
Should the Iraqis choose to preserve the Quran, they likely won’t have to take many extra precautions.
“Climate control is the first step,” said Jim Hinz, the director of book conservation at the Conservation
Center for Art and Historic Artifacts (CCAHA) in Philadelphia. Humidity and temperature are key, he
said, with cooler temperatures being better. Books should also be kept out of direct light, he said.
On Dec. 13, 2003, Mr. Hussein was captured by US forces after being found in a hole in the ground at a
farmhouse in ad-Dawr near Tikrit. Mr. Hussein was hanged on Dec. 30, 2006. (Sources: The Guardian,
12/19/10; LifeScience, 12/21/10) 6
Chicago Zoo Creating First Blood Registry for Apes
Officials at a Chicago zoo have produced an international registry to record the blood types of captive
apes on four continents in hopes of setting up the first ape blood bank.
The project’s roots go back to April 2005, when Mumbali, an adolescent female gorilla, was dying of a
mysterious infection at Lincoln Park Zoo. In a last-ditch effort to save her life,
veterinarians and keepers anesthetized Mumbali as well as a male gorilla named
Kwan, laid them side by side, and sent Kwan’s blood directly from his arm into
hers.
Kwan munches on a
snowball at Lincoln
Park
Zoo.
(Photo:
Chicago Tribune)
It was a crude procedure, similar to the way transfusions were done for humans
before the blood bank was invented at Cook County Hospital in 1937. But there
was little veterinary literature on gorilla blood types, such as whether they have
different ABO blood groups like humans or if they needed to have blood
matched to their own for a successful transfusion. “It’s one of the most basic
pieces of knowledge we need for the care of our animals, and it simply wasn’t
there,” ape-keeper Jill Moyse said.
Mumbali died despite the intervention. Afterward, as keepers and veterinarians
met to grieve her passing, Ms. Moyse told them Mumbali's death “could only
make sense if we can make something good come out of it.”
Five years later, Ms. Moyse and Kathryn Gamble, the zoo’s chief veterinarian, have created an entirely
new body of literature on great ape hematology. And they have produced an international registry to record the blood types of apes.
(continued on page 14)
ABC Newsletter
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January 7, 2011
Ape Blood Registry (continued from page 13)
The registry represents all four great ape species – gorillas, orangutans, chimpanzees and bonobos. In
North America, it encompasses nearly every healthy male and female adult of the species who could donate blood if another ape of its species with the same blood type needed a transfusion.
“You don’t want to transfuse the wrong type of blood because a transfusion reaction can make a bad
situation even worse,” said Ms. Gamble, who recently published the project’s research in the journal Zoo
Biology. “These are small populations,” she said, “so emergency calls for blood are pretty rare. But when
you need it, you really, desperately need it.”
The project has verified that the blood of different ape species isn’t interchangeable between species or
humans, Ms. Gamble said. It found that bonobos have only Type A blood, while orangutans have all four
types: A, B, AB and O. Before the project began, the only species of great apes with known blood groups
were chimpanzees, the majority of which have Type A blood. That is known because chimps are frequently used as stand-ins for humans in medical research.
To learn more, the Lincoln Park project turned to a Danish company, Eldon Biologicals, which a few
years ago revolutionized blood typing with small, chemically coated cards. A blood smear on the cards
quickly reveals the donor's blood type. Ms. Gamble and Ms. Moyse sent the cards out to North American
and European zoos with ape collections and to African and Asian sanctuaries that rehabilitate injured and
abandoned wild apes to restore them to the wilderness. “Everybody we contacted liked the idea of what
we are doing,” Ms. Moyse said.
Because US Customs has strict controls about importing blood products, sanctuaries that lacked personnel
to do the card analysis could not send the cards to Chicago, so Ms. Moyse sent them digital cameras to
photograph the completed cards and e-mail the photos for analysis at Lincoln Park. Once the cards went
out, it was several years before most eligible apes in the covered institutions had their analyses done.
Getting a blood sample from apes is no easy task. Though the test needs only a tiny blood smear, most big
apes won’t willingly undergo a jab of a sharp needle for a blood sample. Because anesthesia is risky,
keepers won't put animals down just for a blood sample. They do, however, anesthetize each of their adult
apes roughly every two years for thorough physicals, so the project had to wait to get its blood. As the
blood typing cards return to Chicago from around the world, they are revealing new information about the
great apes. (Source: Chicago Tribune, 12/15/10) 6
BRIEFLY NOTED
US spending for healthcare in 2009 grew at the slowest rate in 50 years, according to an annual
report from the Centers for Medicaid and Medicare Services (CMS) released Wednesday. Spending
growth increased 4 percent compared to 4.7 percent in 2008. Total health expenditures reached $2.5 trillion, or about $8,086 per person. That represents 17.6 percent of the nation's gross domestic product, up
from 16.6 percent in 2008, reflecting a larger portion of a smaller economy. The drop in spending growth
is attributed to high unemployment, which means the loss of health insurance for many, and deferred
medical care, according to Anne B. Martin, an economist and principal author of the report, issued by the
office of the actuary at CMS. The number of visits to doctors’ offices apparently declined. Many hospitals
reported fewer admissions, as patients put off medical procedures, and many hospitals reduced their capital investments. Spending on dental services declined slightly. The report is available at:
www.cms.gov/NationalHealthExpendData/02_NationalHealthAccountsHistorical.asp#TopOfPage
(Sources: CMS report, 1/5/11; The New York Times, 1/6/11) 6
ABC Newsletter
-15-
January 7, 2011
INSIDE ABC
Article on ABC Communications Strategy Published in UK
ABC’s commitment to sharing information with its members and others in the blood community is highlighted in an article by ABC CEO Jim MacPherson in the most recent issue of Blood and Transplant
Matters. In “Knowledge is Power: The ABC Experience,” Mr. MacPherson emphasizes a number of
manifestations of ABC’s long-standing practices of distributing information, including the ABC Newsletter, which he says was “downright revolutionary” when it was started in the 1960s. Mr. MacPherson also
highlights ABC’s use of other forms of communication – such as listservs, MCNs, and monographs – and
he closes by describing the role of ABC’s new Appropriate Inventory Management System in collecting
and distributing information on best practices, adverse and optimal patient outcomes, trends, and new
ways of treating patients with transfusions. Blood and Transplant Matters is a monthly publication intended for the hospitals served by the Blood and Transplant, a special health authority of the National
Health Service in the UK. It can be accessed through the association’s website, at
www.blood.co.uk/pdf/publications/blood_matters_32.pdf.
Webinar on Data Warehouse Next Week for ABC Members
Members of America’s Blood Centers are urged to attend a webinar next Thursday, from 1-2 p.m. Eastern, to learn about the benefits of the Data Warehouse. ABC is offering an opportunity to review the Data
Warehouse project status by participating in a web demonstration of a few reporting options for data
analysis. This demonstration will show how the Data Warehouse can provide information on:
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New and repeat donors by donor demographics (e.g., age, blood type, ethnicity, gender);
Donor deferrals (e.g., percentage of hemoglobin related deferrals);
Donation analysis (e.g., automation vs. whole blood; fixed site vs. mobile);
Product analysis (e.g., prevalence leukoreduced or irradiated by product group ); and
Test analysis (e.g., prevalence HIV-positive in first-time donors).
For call-in and log-on information, members can access MCN 10-210 on the ABC members website at
https://members.americasblood.org or contact Kellie Kerr at (202) 654-2905; [email protected].
New Year Heralds National Blood Donor Month
National Blood Donor Month (NBDM) began last Saturday. NMDP celebrates life and how easily individuals can give the gift of life by thanking blood donors nationwide. Blood centers across the nation are
holding events to emphasize how regular blood donors (those who give at least twice a year) allow millions of patients to live or improve their quality of life. One of every seven patients entering a hospital
will need blood for his or her treatment. Every two seconds, someone, somewhere in America, needs a
blood transfusion. More than 40,000 units of blood are needed every day in this country and 1 pint of
blood can save up to three lives.
(continued on page 16)
ABC Newsletter
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January 7, 2011
INSIDE ABC (continued from page 15)
ABC is providing the following link to resources available on the Members website to assist center personnel
during
the
annual
NBDM
celebration
to
thank
blood
donors:
http://members.americasblood.org/go.cfm?do=Page.View&pid=21#NBDM
Also, please remember to check the 2011 calendar of events for a listing of holidays, celebrations, and
events
to
assist
or
incorporate
into
your
planning:
http://members.americasblood.org/go.cfm?do=Page.View&pid=147#2011_Calendar_of_Events
Please contact Mack Benton at [email protected] with any questions or concerns. 6
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 Newsletter Editor Robert Kapler at
[email protected] or fax them to (202) 393-1282. Please include your correct title and organization as well as your phone number.
LEGISLATIVE NEWS
The Republican takeover of the US House is changing the political power dynamic across the nation, and nowhere is that more apparent than in Michigan. Two of the state’s US House members –
Democrats John Conyers (Judiciary Committee) and Sander Levin (Ways and Means Committee) are
losing their committee chairmanships. But four others from the state are stepping into new leadership
roles in the 112th Congress. Fred Upton, a Republican from St. Joseph, is taking over as chairman of the
House Energy and Commerce Committee; Republican Dave Camp of Midland is replacing Mr. Levin as
head of the House Ways and Means Committee; Democrat Debbie Stabenow of Lansing is the incoming
chair of the Senate Committee on Agriculture, Nutrition, and Forestry; Howell Republican Mike Rogers
will chair the House Permanent Select Committee on Intelligence; and Mr. Levin will still be the taxwriting committee's ranking Democrat, and his younger brother, Carl Levin, is expected to retain his
chairmanship of the Senate Armed Services panel. All in all, not bad for a state with five new members
heading to Washington, despite losing 69 years worth of congressional experience from outgoing Democrats Bart Stupak, Carolyn Cheeks Kilpatrick and Mark Schauer, and Republicans Pete Hoekstra and
Vernon Ehlers. First-time congressmen are taking over four of those seats and the fifth is returning to
Washington after being ousted two years ago. The lone new Democrat entering Congress from Michigan
is Hansen Clarke, a state senator and ex-Conyers staffer who beat Ms. Kilpatrick in the primary. Mr.
Clarke, who has a painting degree from Cornell University and a law degree from Georgetown University, pledged to fight for the downtrodden in his hometown of Detroit and the handful of other
southeastern Michigan communities he’ll represent. The Michigan House delegation, which leaned 8-7
Democratic during the last term, now consists of nine Republicans and six Democrats, and two of those
Democrats could face each other in 2012 because of reapportionment. The state – the only in the nation to
lose population in the 2010 census count – is losing a seat in Congress. While member of the delegation
likely will split on any attempt to repeal President Barack Obama’s healthcare overhaul, they are expected
to band together to push for more federal dollars for the Great Lakes. President Obama has vowed to pro(continued on page 17)
ABC Newsletter
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January 7, 2011
LEGISLATIVE NEWS (continued from page 16)
vide $5 billion over 10 years to fund a comprehensive Great Lakes restoration, and Michigan lawmakers
are lobbying for even more. “Michigan members are in a position to leave their mark on the important
business of the 112th Congress,” said David Dulio, a political science professor at Oakland University.
(Source: The Associated Press, 12/19/10)
Minnesota Sens. Amy Klobuchar (D) and Al Franken (D) along with Rep. Erik Paulsen (R) have
championed the medical device industry, which believes the Food and Drug Administration is going
a bit overboard with its 510(k) reform proposals. The proposals would further define what devices
need premarket 510(k) clearance, a process under which companies get accelerated approval to market a
new product if they can show it is similar to an already approved device. In a conference call in September, officials of AdvaMed, the medical device lobbying group, said a good number of the 70
recommendations offered by FDA “could slow medical progress.” One recommendation that AdvaMed
likes is a plan to beef up training and professional development for regulatory managers and reviewers to
keep them abreast of new technological and scientific advances. But it doesn’t like recommendations that
together “redefine the terminology of substantial equivalency.” The agency has recommended limits on
the use of predicate devices, including the bundling of multiple predicates in a 510(k) application. Without the ability to bundle multiple predicates, device manufacturers would have to wait longer while the
agency reviewed and cleared each (see ABC Newsletter, 9/17/10). With the FDA close to releasing its
recommendations on 510(k), Minnesota recently brought out the big guns. In December, a bipartisan
group of 15 senators sent a letter to FDA Commissioner Margaret Hamburg, MD, urging her agency,
among other things, to adopt a more deliberate, cautious approach to amending 510(k) versus the radical
wholesale restructuring that medical device firms are fearing. The letter says that some reforms would
stifle innovation and economic growth, cause the US to lose out to Europe and Asia, and result in unclear
regulatory timelines. The letter was signed by a group that includes liberal Democrats and conservative
Republicans representing the East Coast, Midwest, and South. Minnesota, Massachusetts, Indiana, and
North Carolina boast sizable medical technology clusters. (Source: MedCity News, Cleveland, Ohio,
12/9/10)
Michigan recently became the 40th state to allow 16-year-old blood donors, with legislation that was
passed last month and went into effect on New Year’s Day. The new state law allows 16 year olds to
donate blood as long as they have permission from their parents. (Donors 17 and older may give blood
without parental consent.) The change has been in the works since May 2007, when Michigan Sen.
Wayne Kulpers (R-30th) introduced “Jenna’s Law,” named after his daughter, who tried to donate blood
when she was 16 but was turned away. However, that measure failed when the state’s legislative session
ended before the bill could be brought to a vote. The new bill, HB 5614, was introduced by Rep. Roy
Schmidt (D-Grand Rapids) in 2009. In a statement, Michigan Blood said the current measure passed
“largely through the efforts” of Rep. Schmidt. The blood center planned to welcome its first 16-year-old
donors on Monday, Jan. 3. “We’ve been preparing for this for quite some time,” said Jim Childress, vice
president of Community Relations for Michigan Blood. “We’ve had a lot of 16-year-olds express interest
in donating blood, so we think this is going to be very popular with our younger donors.” He said that
high school donors ages 17 and older make up 12 percent of donations to Michigan Blood, and that 16year-olds could bring that share up to 15 percent. “In January and February alone, we have 68 high school
drives across the state,” he explained. “We’re expecting to see a lot of first-time 16-year-old donors at
those drives.” That would have “an immediate and positive impact on ensuring the blood supply” for the
30-plus hospitals Michigan Blood serves, he added. Michigan’s tough economic conditions have taken a
toll on blood drives there, as collections at drives sponsored by manufacturing facilities and other busi(continued on page 18)
ABC Newsletter
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January 7, 2011
LEGISLATIVE NEWS (continued from page 17)
nesses have gone down. That means the expected increase in collections from high school students will be
particularly important. (Source: Michigan Blood press release, 12/30/10; www.wzzm.com, 12/16/10;
www.mlive.com, 12/16/10 and 1/5/11) 6
REGULATORY NEWS
The Food and Drug Administration recently updated its 2007 guidance on lookback for hepatitis C
virus (HCV). The changes do not include any new requirements, but the new document updates a number
of references to reflect new technologies for anti-HCV testing; revises the dates for completion of historical lookback and the cutoff for historical review of electronic records; moves certain recommendations
for historical lookback to a new appendix; expands the list of people a transfusion service should notify to
include a recipient’s physician of record, if that recipient has received blood or blood products from a
donor found to be infected with HCV; clarifies the time frames in which blood establishments must perform appropriate procedures after a donor tests reactive for evidence of HCV infection; and includes a
number of clarifying but “nonsubstantive changes.” The guidance, “ ‘Lookback’ for Hepatitis C Virus
(HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV,” can be
accessed
through
FDA’s
website,
at
www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidance
s/UCM238488.pdf.
The National Institutes of Health’s (NIH) National Heart, Lung, and Blood Institute (NHLBI) last
month extended its call for comments on efforts to improve the US blood supply through hemovigilance. The comments relate to a collaborative pilot research study that involves the American Red Cross,
Blood Systems, and the New York Blood Center (see ABC Newsletter, 10/1/2010). The final goal is a
research-quality biovigilance database that will integrate information on blood donors, disease marker
testing, and blood components from various centers. The three organizations will first standardize how
they classify donation testing results for HIV, hepatitis C virus (HCV), hepatitis B virus (HBV), and
HTLV. They will then collect information from an estimated 4,150 adult blood donors to determine infectious disease marker prevalence and incidence for infection with the viruses. Through their research
database, they will then determine nationally representative infectious disease marker prevalence and
incidence rates, overall and for certain demographic groups. Finally, they will analyze the data to measure
the success of various centers at preventing donations from donors with current predominant risk factors,
which they will determine through interviews with the donors. According to the call for comments, which
was published in the Federal Register on Dec. 17, 2010, information on current risk factors in blood donors is largely unavailable in the US, as earlier studies of risk factor profiles among HIV-infected donors
and HTLV- and HCV-seropositive (and indeterminate) donors have ended. In its pilot form, this database
will include information on nearly 60 percent of all blood donors and donations in the US. In the future, it
could be expanded to include other blood centers or re-focused on emerging safety threats. NHLBI originally requested comments in late September and set a 60-day public comment period. The new request
pushes the deadline for comments to Jan. 16, 2011, 30 days after its publication. Comments may be submitted to the Office of Management and Budget, Office of Regulatory Affairs, Attention: Desk Officer
for NIH, either by e-mail to [email protected] or by fax to (202) 395-6974. The contact
person for more information is Simone Glynn, MD, the project officer for NHLBI, who may be reached at
(301) 435-0065 or [email protected]. The Federal Register announcement is available at
http://edocket.access.gpo.gov/2010/2010-31734.htm.
REGULATORY NEWS (continued on page 19)
ABC Newsletter
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January 7, 2011
REGULATORY NEWS (continued from page 18)
The Joint Commission submitted, in December, a set of seven blood management performance
measures to the National Quality Forum (NQF). The standardized measures in The Joint
Commission’s Patient Blood Management set are meant to help assess blood management in the hospital
setting. They include transfusion consent, transfusion indication, plasma transfusion indication, platelet
transfusion indication, blood administration indication, preoperative anemia screening, and preoperative
blood type testing, and antibody screening. The set will now be assessed by NQF, a nonprofit that aims to
improve healthcare by focusing on performance. The Joint Commission, which accredits and certifies
more than 18,000 US healthcare organizations and programs, began developing its blood performance
measures in 2007. Once the set of measures was identified, developed, and tested, more than 75 hospitals
pilot tested them. The pilot test results were then assessed by a technical advisory panel, which included
blood officials from major blood centers, medical facilities, universities, and government agencies. In a
statement posted on its website on Jan. 3, The Joint Commission said it expects the NQF decision within a
few
months.
More
information
about
the
project
is
available
at
www.jointcommission.org/patient_blood_management_performance_measures_project/. 6
PRODUCT RECALLS
The Food and Drug Administration has announced a Class I Recall of Fresenius Kabi LLC, Red
Blood Cells (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices. The sets included in
the recall are Red Blood Cell (RBC) Set (catalog number 9007601) lot numbers WKT252, YLT061,
ZCT011, and ZGT052 manufactured from Oct. 1, 2007, to July 30, 2010. The implicated sets have led to
the removal of greater amounts of red blood cells than intended, resulting in hemodilution. These units
are used for depletion or exchange of red blood cells during therapeutic apheresis procedures, when blood
is removed from the patient and separated into its component parts. Though most members of America’s
Blood Centers swill not be affected by this recall, some of the members may provide this service using
the recalled products. The MedWatch safety alert, including a link to the recall notice, is at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation
The Food and Drug Administration announced on Thursday the recall of Triad Alcohol Prep Pads,
Swabs and Swabsticks due to potential microbial contamination with Bacillus cereus. These overthe-counter products are sold by Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical,
Walgreens, CVS, and Conzellin. Considering that Cardinal Health and PSS Select are distributors to
healthcare facilities (and have GPO contracts) it is possible that some blood centers use this product.
Therefore, blood centers are urged to check their source of alcohol preps/pads/swabsticks. The affected
Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks can be identified if “Triad Group” is listed
as the manufacturer, or if the products are manufactured for a third party and use the names listed above
on their packaging. The recall notice is at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.h
tm 6
GLOBAL NEWS
A Labor Party member of the Scottish Parliament (MSP) has called for the government to mandate
that all workers should be given paid time off to donate blood. Employers are not required to give
staff time off to give blood, but Highland MSP Rhoda Grant believes the incentive will boost donations.
(continued on page 20)
ABC Newsletter
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January 7, 2011
GLOBAL NEWS (continued from page 19)
The Scottish National Blood Transfusion Service is calling for 190,000 more donors to meet future blood
demands to offset the loss of supply caused by severe winter conditions during the Christmas holiday.
The transfusion service said it managed to maintain supplies to hospitals over Christmas in spite of the
cold weather, but many donor clinics in rural areas were badly affected. Ms. Grant, who sits on the Holyrood health committee, said: “I am proud to be a regular blood donor, and it is particularly important to
maintain supplies during the cold weather. I want to encourage every Scot who has not already done so to
register to give blood. To help achieve this I believe that employees should have the right to paid time off
work to donate blood.” However, Garry Clark, head of policy at the Scottish Chambers of Commerce,
said he believed any moves to force employers to give staff blood leave through legislation would be
misguided. He said, “We would encourage employers to be as fair as possible with staff, but I don’t think
it’s an area where political parties should get involved.” (Source: BBC News, 12/30/10) 6
Earlier 2010 Study Suggests Transfusion May Be Just a ‘Marker’ for NEC
The findings of Blau et al., published online in The Journal of Pediatrics in November 2010 (see page 1),
do not support those of a retrospective, case-control study first published online in the same journal in
July 2010.
That study, led by Cassandra D. Josephson, MD, of Emory University School of Medicine with a team
that included researchers from New York Blood Center, concluded that in most patients, red blood cell
(RBC) transfusions were “temporally unrelated to NEC [necrotizing entercolitis] and may be merely a
marker of overall severity of illness.”
For that study, Josephson et al. reviewed data from two level III neonatal intensive care units (NICUs) to
see if they could find an association between RBC transfusions and NEC, and to learn whether the risk of
NEC after RBC transfusions is higher in infants with lower hematocrit levels and advanced postnatal age.
The team hypothesized that RBC transfusions are a risk factor for the onset of NEC and asserted that the
risk of NEC after RBC transfusions was related to underlying anemia. That assertion, the authors write, is
based on several known factors: that RBC transfusions can trigger gut mucosal injury (damage to the
membrane of the intestinal wall) in patients with severe anemia during cardiopulmonary bypass; that NEC
is associated with a number of conditions marked by anemia, including glucose-6-phosphate dehydrogenase deficiency (G6PD) (a recessive hereditary disease characterized by abnormally low levels of
G6PD, a metabolic enzyme), hemolytic disease of newborn, and twin-to-twin transfusion syndrome; and
that “many stable premature neonates with severe anemia may be in a high cardiac output state with
restricted gut perfusion, which puts them at risk of mucosal injury.”
The team “speculated that RBC transfusions may increase the risk of NEC in infants with severe anemia
and prematurity” and it further hypothesized that “the risk of NEC after RBC transfusions would be most
evident in older premature infants.”
Methodology. The team reviewed medical and laboratory records from 3,725 neonatal admissions
between January 2004 and April 2007 at level III NICU centers at Grady Memorial Hospital and Emory
University Hospital Midtown, both in Atlanta, Ga. The team included in the study infants born at 34
weeks gestation or less who had a history of NEC (Bell stages II and III). The team then identified control
subjects based on admission date, gestational age, and birth weight.
(continued on page 21)
ABC Newsletter
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January 7, 2011
NEC Marker Study (continued from page 20)
Transfusion protocol called for the transfusion of 15 mL/kg leukoreduced, irradiated, CPDA-1-preserved
RBCs stored for 14 days or less according to AABB standards. The team recorded the time elapsed
between the last RBC transfusion received before NEC and the onset of NEC for all infants. The
researchers then compared patients who developed NEC and had RBC transfusions with those who did
not receive a transfusion before NEC. They also recorded the age of the blood, total RBC transfusions,
total volume of RBCs transfused, and number of donor exposures.
Results. The overall incidence of NEC was 2.5 percent (93/3,725) in the total population. Thus, there
were 93 cases in the NEC group and the team was able to find 91 cases for the non-NEC control group.
Demographic data did not reveal significant differences between the NEC and non-NEC control groups,
including transfusion history.
Of the total, there were 18 cases of NEC in patients with birth weights of 1,500 g or more, two of whom
weighed 2,000 g or more at birth. Eighty-one (87 percent) neonates had definite NEC (stage II), and
12/93 (13 percent) had advanced disease (stage III). Mortality in this population was 18 percent (17/93).
Overall, patients with “transfusion-associated” NEC were born at earlier gestation ages and had lower
birth weights. Similar to the findings of earlier studies, the team “identified an association of RBC
transfusions with late-onset NEC.” However, the NEC/RBC-transfused patients in this study seemed to be
sicker and thus needed more support.
A similar number of infants received transfusions in the NEC and non-NEC control groups, but the
NEC/RBC group generally developed the disease at a later postnatal age than in the NEC/non-RBC
transfused group (median, 37 versus 13 days).
Among other findings:
6
6
Compared with the NEC subgroup that did not receive transfusions, the NEC subgroup that did
receive transfusion had lower hematocrit at birth, one week before the onset of NEC, and at the
time of onset of NEC.
In the NEC/RBC group, patients with late-onset NEC received more RBC transfusions and a
greater total volume of RBC, and were exposed to more donors.
Conclusions. Previous research has shown that blood transfusions can decrease blood flow to the
intestines in VLBW premature infants, which may damage the tissue lining the digestive tract. In the
authors’ words, “RBC transfusions can dampen the normal postprandial [after eating] increase in mesenteric [abdominal or intestinal] blood flow in premature infants, particularly in those with a birth weight
<1250 g.
“This immaturity of vascular autoregulation in extremely premature infants is likely related to low endothelial [nitric oxide] synthesis, and could explain a higher risk of mucosal injury after transfusions in this
patient population.”
The team concludes that “[a]lthough RBC transfusions before the onset of NEC appear to be a surrogate
of the overall severity of illness in most patients, further study is needed to determine whether RBC
transfusions, by triggering splanchnic vasoconstriction [constriction of the blood vessels in the spleen],
could trigger intestinal injury in extremely premature infants.”
Citation: Josephson CD, et al. Do red cell transfusions increase the risk of necrotizing enterocolitis in
premature infants? J Pediatr. 2010 Dec;157(6):972-978.e1-3. Epub 2010 Jul 21. 6
ABC Newsletter
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January 7, 2011
‘TRAGI’ Study (continued from page 1)
Methodology. The team, from the Maria Fareri Children’s Hospital at Westchester Medical Center in
Valhalla, N.Y., reviewed the cases of 256 VLBW neonates out of 883 admissions over 18 months in six
level II and III neonatal intensive care units (NICUs) from a 5,000 square-mile area.
In a 2006 study, the institution found a temporal association between RBCs and the development of NEC
in VLBW neonates. The team sought to determine whether those findings were due to a sampling error,
so it used a new cohort of VLBW patients. The team hypothesized that a late-onset form of NEC may
involve injury occurring shortly after transfusion.
Participants were divided into those who developed NEC less than 48 hours after transfusion (the condition the researchers named TRAGI), those who developed NEC unrelated to the timing of transfusion,
and those who were never transfused. All transfused patients were given irradiated, leukoreduced RBCs
stored in ADSOL-3 storage media and transfused within 30 minutes of release from the blood bank. The
number of transfusions and age of blood did not differ between patients with TRAGI or NEC or those
without TRAGI. Indications for transfusion included anemia or failure to observe a rise in reticulocyte
counts above 5 percent at or below at hematocrit of 25 percent. A diagnosis of NEC was made when observing standard NEC symptoms at Bell stage severity IIb or greater.
Results. Of the total 256 VLBW neonates, 36 developed NEC, of which nine (25 percent) were associated with RBC transfusions. The timing of RBC transfusion and NEC onset differed from random,
showing a distribution not uniform over time “consistent with the possibility of a causative relationship in
certain cases of NEC.” The more immature the neonate, the later the onset of NEC, “creating a curious
centering of occurrence at a median of 31 weeks post-conceptual age.” RBC-associated cases had lower
birth weight, hematocrit, and the rapid onset of symptoms (less than five hours).
The findings corroborated those of the earlier report, except that NEC occurred sooner after transfusion
(average 5 vs. 22 hours). “[O]ur previous observation of a temporal association (< 48 hours) between
RBC transfusion and the development of NEC in VLBW neonates representing 25 percent of all NEC
cases persists,” the authors write. NEC neonates who received a transfusion “were significantly more
anemic than non-affected [neonates] or patients with NEC who had never received a transfusion, were
lower birth weight, were older, and had a higher prevalence of treated [patent ductus arteriosus] > 2
weeks before onset of signs.”
The authors, while suggesting that the transfusion association is strong enough to warrant the name
TRAGI, struck a cautious note in their discussion. They said the results, based on a small sample size, are
best used as a basis for future hypotheses and research using larger study groups.
Editorial Response. In an accompanying editorial, Robert D. Christensen, MD, of the Women and Newborns Program at Intermountain Healthcare in Ogden, Utah, said that the findings of this study, like
others, support “transfusion-associated NEC” as a legitimate subtype of NEC, but certainly do not prove a
direct causal relationship between transfusions and NEC.
He notes that the largest studies show that between 25 percent and 35 percent of NEC cases develop between two and 48 hours of an RBC transfusion, “but generally closer to 12 hours,” and neonates with
transfusion-associated NEC are generally born much earlier and have multiple transfusions compared
with neonates who develop NEC unrelated to transfusions.
He also posits that a chicken-and-egg problem may exist: “…[T]he transfusion might be an epiphenomenologic marker of imminent NEC.” Thus, if a baby’s hematocrit level drops far enough to trigger a trans(continued on page 23)
ABC Newsletter
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January 7, 2011
‘TRAGI’ Study (continued from page 22)
fusion, anemia might be severe enough to impair blood flow to the intestine, possibly a major factor in the
development of NEC.
Dr. Christensen also addresses the idea that perhaps blood storage time plays a role in the development of
NEC, with older blood more likely to undergo storage lesion – reduced deformability, increased adhesion
and lower nitric oxide.
Finally, he suggests that elements of one, two, or all three factors – some TRALI like mechanism in the
gut, damage caused by the anemia itself, and/or storage lesion – may contribute to the development of
NEC.
Dr. Christensen traces the first link between transfusion and NEC back to the mid-1980s, when the Centers for Disease Control and Prevention was called in to help investigate an outbreak of 20 cases at one
hospital in a three-month period. Thirty-one percent of VLBW neonates and 11 percent of infants weighing at birth more than 1,500 grams developed NEC in that hospital during that period. Investigators
determined an odds ratio for NEC after transfusion of 15.1 (95 percent confidence interval, 2.6-92.5) but
could find no changes in blood bank procedures or blood supply that might have caused the outbreak,
which appeared to cease without any change in transfusion practice.
About 10 years later, Bednarek et al. identified an association between transfusing more RBCs and an
increase in NEC in six Boston-area NICUs, a finding that was corroborated more or less in subsequent
case reports and small retrospective studies. Dr. Christensen himself was part of a team that focused exclusively on Bell stage III NEC (the most advanced stage in Bell’s ystem used to assess NEC severity)
and also found an association, with 40 of 112 NEC cases occurring within 48 hours – with a mean of 18
hours – following an RBC transfusion.
But Dr. Christensen, like other researchers, warns against jumping to any conclusions about a direct
causal relationship and points out the inherent limitations of all retrospective studies. “… [I]t seems certain that an association indeed exists between ‘late’ RBC transfusions (given after the first several weeks)
and the development of NEC. Caution must be taken when interpreting the clinical relevance of this association, however. First, not all cases of NEC follow an RBC transfusion. In fact … the majority of cases
of NEC are not temporally related to a transfusion. Second, the great majority of transfusions administered in the NICU are not followed by the development of NEC. Given these two certainties, it is clear
that transfusions are not the cause of NEC. The critical question is whether in some cases of NEC, an
immediately antecedent RBC transfusion is part of the pathogenesis.”
One Physician’s Reaction. Elie M. Richa, MD, associate medical director of the University of Chicago
Medical Center’s Blood Bank and Transfusion Medicine department, wondered whether the study by
Blau et al. would have benefited by focusing more on the ages of the blood units transfused. “Further
studies, especially large double-blinded and controlled studies, are obviously needed to understand the
pathophysiology of the TRAGI entity as well as the relationship between the shelf life of the transfused
blood units and NEC,” Dr. Richa said.
Dr. Richa suggested a multi-center study on the incidence of TRAGI or transfusions associated with NEC
that focuses on the effects of blood storage, storage lesion and possibly additive solutions. “RBCs are
stored in an additive solution that might contain mannitol and adenine, which have been associated with
renal failure in VLBW neonates, and maybe even contribute to sicker patients who would ultimately develop NEC. We would wonder if routine washing of packed RBCs would affect the NEC risk,” he said.
(continued on page 24)
ABC Newsletter
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January 7, 2011
‘TRAGI’ Study (continued from page 23)
There are data on the association of platelets and fresh frozen plasma in TRALI cases. “One would wonder if platelet products or even fresh frozen plasma transfusion would be related to NEC and TRAGI, or is
it only packed RBCs involved in this entity?” Dr. Richa said.
He favors establishing guidelines for reporting NEC cases among transfused neonates to biovigilance
network. “That will definitely help out by making the clinicians be more aware of these phenomena. And,
of course, more data will be collected and analyzed.”
Citation: Blau J et al. Transfusion-related acute gut injury: necrotizing enterocolitis in very low birth
weight neonates after packed red blood cell transfusion. J Pediatr. 2010 Nov 9. [Epub ahead of print] 6
XMRV Studies (continued from page 1)
Research has not shown that XMRV causes CFS; nor has it shown that the virus can be transmitted via
transfusions. However, those possibilities have been on the blood community’s radar screen since October 2009, when Science published the results of a study that found XMRV in the blood of 67 percent of
patients with CFS, but less than 4 percent of healthy control subjects. A number of studies published between then and now have reached different conclusions about the possible link between CFS and XMRV.
The virus has been found in patients with prostate cancer, but, again, researchers do not know whether it
causes the disease.
Collectively, the four Retrovirology studies “reinforce the need to take extreme precautions in excluding
mouse DNA contamination” in research on XMRV, according to Robert A. Smith, PhD, of the University
of Washington, who wrote an editorial that accompanies the studies. (Editor’s note: Mice, mouse cells,
cell lines and fluids are commonly used in research laboratories and by manufacturers that produce reagents; their presence in those laboratories and facilities makes contamination possible.)
Previous Studies May Have Used Contaminated Samples. One Retrovirology study suggests that the
XMRV found in previous studies may be the result of contamination in the laboratory, rather than infection of the patients and healthy controls. It was conducted by Stéphane Hué, PhD, a post-doctoral
researcher at the University College London; Greg J. Towers, PhD, a senior research fellow with the university’s Wellcome Trust Sanger Institute; and 11 of their colleagues.
The researchers demonstrated that polymerase chain reaction (PCR) primers which were thought to amplify only XMRV can also amplify viral sequences from mouse DNA. They conclude, then, that what had
been identified by other researchers as XMRV may have been a result of contamination with mouse
DNA. In addition, they sequenced XMRV from 22Rv1, a prostate cancer cell line that is infected with a
xenotropic murine leukemia virus (MLV-X) indistinguishable from XMRV. The sequences from the cell
line were more diverse than the samples from patients. That is the opposite of what would be expected,
since mutations to viruses happen during infection and transmission. Thus the finding, the authors say, is
“difficult to reconcile with the hypothesis that published XMRV sequences are related by a process of
infectious transmission.”
They conclude that the XMRV detected by PCR in patient samples “is the likely result of PCR contamination with mouse DNA.” They also conclude that the prostate cancer cell line “was probably infected
with XMRV during xenografting in mice.” Finally, they “propose that XMRV might not be a genuine
human pathogen.”
(continued on page 25)
ABC Newsletter
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January 7, 2011
XMRV Studies (continued from page 24)
Test Kit May Have Been Contaminated. A second study is a short report that focuses on the reverse
transcription (RT)-PCR test kits used to detect XMRV in sera from CFS patients in Japan. The researchers, led by Dr. Takayuki Miyazawa of Kyoto University, tested four one-step RT-PCR kits. They used
primer sets to amplify the partial gag gene sequences of XMRV and other murine leukemia viruses
(MLVs) and found that enzyme mixtures in the kit manufactured by Invitrogen were contaminated by
RNA from a polytropic endogenous MLV, a kind of leukemia virus that infects a range of hosts, including mice.
Their conclusion is that researchers who are studying XMRV in patients with CFS or prostate cancer
“should prudently evaluate the test kits for the presence of endogenous MLV as well as XMRV genomes
prior to PCR and RT-PCR tests.”
Similarity of XMRV and Mouse MLVs
Can Lead to False Positives. Seven
researchers from Tufts University and
New York City, led by Brigette T. Huber,
PhD, of Tufts, used two different PCR
assays to test blood samples from 112
CFS patients and 36 healthy controls.
Their goal was to determine whether
those that tested positive for XMRV were
actually positive for one of the many
very similar MLVs present in mice.
When they used a nested PCR assay that
had been used in another study, they
found positive samples in both the CFS
patients and the healthy controls. However, when they tested the same samples
with a TaqMan qPCR assay, which tests
for a gene sequence that is unique to
XMRV and which does not detect sequences in genomic DNA from mice,
they had no positive results. They also
found that all of the samples that were
positive for XMRV/MLV sequences
were also positive for mouse DNA, and
that most of the samples that were negative for XMRV/MLV were also negative
for mouse DNA.
HHS Group Statement on New XMRV Studies
The four new studies in Retrovirology have not affected the
status of the trials currently underway under the guidance of
the Blood XMRV Scientific Research Working Group, which
was convened by the Department of Health and Human Services. The Working Group released the following statement
last week:
The Blood XMRV Scientific Research Working Group has
discussed the findings from the four studies published in
Retrovirology on Dec. 20, 2010. These studies confirmed
the importance of carefully checking XMRV/MLV relatedpositive results for any evidence of contamination with
mouse genetic materials. The Working Group is proceeding with phase III which will evaluate the clinical
sensitivity and specificity of multiple laboratory assays that
test for the RNA and/or DNA of XMRV/MLVs or antibodies to these viruses. All laboratories have and will continue
to apply best practices and check to the best of their ability
that no contamination with mouse DNA is present before
reporting any positive results. These reports also substantiate the importance of employing tests that not only detect
viral DNA and/or RNA but can also detect the virus itself
(culture) and/or an immunological reaction to the virus.
These tests are reflected in the Working Group planned
phase III study.
According to The Wall Street Journal’s health blog
(12/17/10), the phase III study will test the assays with samples from 30 CFS patients and 40-50 healthy controls. The
testing was expected to begin this month, with results perhaps
available in three months.
The researchers assert that their data “are
compatible with the conclusion that the
detection of MLV-related sequences in
human genomic DNA samples could be
due to contamination with minute and
variable quantities of mouse DNA, most
likely contained in various laboratory reagents.”
(continued on page 26)
ABC Newsletter
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January 7, 2011
XMRV Studies (continued from page 25)
Highly Sensitive Assays Can Detect Contamination. The final study, led by Dr. Mark J. Robinson and
Dr. Otto W. Erlwein, both of Imperial College London, used PCR testing to look for XMRV in DNA
from prostate tissues. To check for contamination, they used the PCR assays to check for both mouse
mitochondrial DNA (mtDNA) or intracisternal A particle (IAP) long terminal repeat DNA, both of which
are present in mouse cells.
The researchers found that 4.8 percent of the tissue samples were positive for XMRV. But they also found
that these samples were also positive for IAP sequences, as were 21.5 percent of the samples that were
negative for XMRV. Finally, they found that many but not all of the samples were positive for mtDNA.
The researchers write that their results show that the “highly sensitive” IAP assay is able to detect contamination with mouse DNA, which they call widespread. But they say less sensitive assays, like the PCR
test used to detect mtDNA, is not as successful in detecting contamination. Overall, they conclude, “This
study highlights the ubiquitous presence of mouse DNA in laboratory specimens and offers a means of
rigorous validation for future studies of murine retroviruses in human disease.”
Studies Set Off a New Round of Debate. The Retrovirology studies set off a wave of competing claims
about their implications. On one hand, Dr. Towers said of the study at the University College London,
“Our conclusion is quite simple: XMRV is not the cause of chronic fatigue syndrome. All our evidence
shows that the sequences from the virus genome in cell culture have contaminated human chronic fatigue
syndrome and prostate cancer samples.” He added that his team’s research did not rule out the possibility
that CFS is caused by some kind of virus. “But we know it is not this virus causing it,” he said.
Tim Peto, MD, an infectious disease consultant at Oxford University, agreed. He told Reuters that “it now
seems really very, very unlikely that XMRV is linked to chronic fatigue syndrome.”
But Judy Mikovits, PhD, of the Whittemore Peterson Institute and a lead author of the Science study,
countered that her team – as well as a team led by FDA’s Shyh-Ching Lo, MD, PhD – “conducted rigorous studies to prevent and rule out any possibility that the results reported were from contamination.” Dr.
Mikovits said in a statement that she and her coauthors stand by their conclusions. “Nothing that has been
published to date refutes our data,” she insisted.
As one doctor who treats patients with CFS said, “The articles make the point that PCR doesn’t work that
well for these viruses, and then they act like that disproves the whole idea.” The problem, Eric Gordon,
MD, told The New York Times, is that the researchers did not evaluate strategies for detecting XMRV
other than PCR testing. (Sources: Wellcome Trust Sanger Institute statement, 12/20/10; Whittemore Peterson Institute statement, 12/20/10; Reuters, 12/20/10; The New York Times, 1/3/11)
Citations. Hue S, et al. Disease-associated XMRV sequences are consistent with laboratory contamination. Retrovirology. 2010 Dec 20;7(1):111 [E-pub ahead of print]. Sato E, et al. An endogenous murine
leukemia viral genome contaminant in a commercial RT-PCR Kit is amplified using standard primers for
XMRV. Retrovirology. 2010 Dec 20;7(1):110 [E-pub ahead of print]. Oakes B, et al. Contamination of
human DNA samples with mouse DNA can lead to false detection of XMRV-like sequences. Retrovirology. 2010 Dec 20;7(1):109 [E-pub ahead of print]. Robinson MJ, et al. Mouse DNA contamination in
human tissue tested for XMRV. Retrovirology. 2010 Dec 20;7(1):108 [E-pub ahead of print]. Smith RA.
Contamination of clinical specimens with MLV-encoding nucleic acids: implications for XMRV and
other candidate human retroviruses. Retrovirology. 2010 Dec 20;7(1):112 [E-pub ahead of print]. 6
ABC Newsletter
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January 7, 2011
STOPLIGHT: Status of America’s Blood Centers’ Blood Supply
Percent of Regional Inventory at
2 Days Supply or Less, Jan. 5, 2011
Total ABC Red Cell Inventory
1%
6%
1%
12%
1%
12%
1%
10%
1%
3%
18%
19%
3%
77%
73%
72%
71%
73%
0%
72%
3%
42%
7%
19%
17%
17%
14%
1-Dec
8-Dec 15-Dec 22-Dec 29-Dec
16%
8%
Red (1 day or less)
Yellow (2 days)
Green (3 days or m ore)
No Report
1%
7%
9%
6%
5-Jan
28%
Total
East
Midw est
South
West
Daily Updates are available at:
www.AmericasBlood.org
INFECTIOUS DISEASE UPDATES
DENGUE
The Centers for Disease Control and Prevention has released data showing that the
incidence of dengue in Puerto Rico has fallen
below the epidemic threshold. The government
of Puerto Rico has announced the end of the dengue epidemic that claimed 31 lives. Health
Secretary Lorenzo Gonzalez, MD,said on Dec. 30
that the number of cases has dropped steadily in
recent weeks. More than 12,000 cases have been
reported in the US Caribbean territory since health
officials declared an epidemic last February. Dr.
Gonzalez said 28 of those cases were of the more
serious hemorrhagic dengue . In 1998, the virus
killed 19 people and sickened 17,000. (Sources:
The Centers for Disease Control and Prevention,
1/3/11; The Associated Press, 12/31/10) 6
Source: CDC
ABC Newsletter
-28-
January 7, 2011
MEMBER NEWS
Suncoast Communities Blood Bank opened its first donor facility in Manatee County, Fla., on Jan.
3. Scott Bush, Suncoast’s COO, told a local newspaper that the center hopes to open another facility in
the county in the next month or so. Suncoast provides blood and blood products to a number of hospitals
and healthcare systems in Sarasota, and in August, it began serving three additional facilities in Manatee
and Sarasota counties. The new donor center is 1,000 square feet, has four donor beds, a number of high
definition televisions, and a touch-screen computer where donors can confidentially enter their medical
information. A grand opening ceremony is planned for Jan. 15. (Source: Bradenton.com, 1/4/11)
Upstate New York Transplant Services (UNYTS) recently began a new partnership with Erie
County Medical Center, the primary trauma hospital in Buffalo, N.Y. With the partnership, UNYTS
became the primary provider of blood products to this facility. It already was the primary supplier for the
six hospitals in Niagara and Wyoming counties and for the entire Kaleida Health System, the largest
healthcare provider in western New York. The addition means UNYTS provides more than 60 percent of
the blood supply to the region. UNTYS expects to supply 8,000-9,000 additional units of blood and 1,000
more platelet pheresis products in 2011, according to Christopher Straub, vice president of Blood Services for the center. UNYTS was founded in 1981, and it expanded into blood services in 2007 by
creating a community-based processing and distribution center. (Source: Buffalo Business First, 1/3/11)
PEOPLE
The Food and Drug Administration has had a shake-up in its number two position: On
Tuesday, Maryland’s governor, Martin O’Malley (D), announced that he had hired
Joshua Sharfstein, MD (right), the agency’s deputy commissioner, as the new secretary
of Health and Mental Hygiene for the state of Maryland. The following day, The IN
VIVO Blog reported that John Taylor (below right), who has been FDA’s counselor to
the commissioner for the past 14 months, would become its acting principle deputy
commissioner. That appointment will last for 60 days, while FDA decides on a permanent appointment. Mr. Taylor has been working with FDA issues for 20 years, including
stints at Abbott (from 2005 to 2007) and BIO (from 2007-2009). Otherwise, he has
worked in a number of positions in FDA’s chief counsel’s office, enforcement, and regulatory affairs since 1991. Dr. Sharfstein was appointed FDA’s deputy commissioner in
March 2009 and served briefly as its acting chief before Margaret Hamburg, MD, was
appointed to lead the agency. During Dr. Sharfstein’s tenure as deputy commissioner,
FDA has expanded its oversight of new products, and he has been leading its review of
the 501(k) approval process. (Sources: MedPage Today, 1/4/11; The IN VIVO Blog,
1/4/11 and 1/5/11)
Richard “Rick” Walsh, a longtime civic leader in Central Florida who became
chairman of the board of directors of Orlando-based Florida’s Blood Centers (FBC)
was named as one of the finalists for the Orlando Sentinel’s “Central Floridian of the
Year.” Mr. Walsh took over as chairman in April 2010 to succeed Leighton Yates,
who served on FBC’s board for more than three decades. Mr. Walsh was part of a
newly constituted board that forged a series of governance reforms and a bill of rights
for blood donors. Mr. Walsh has served as chair and CEO of the Knob Hill Companies, which includes a strategic consulting firm as well as Knob Hill Media, publisher
of Winter Park Magazine.
ABC Newsletter
-29-
January 7, 2011
POSITIONS AVAILABLE:
Classified advertisements, including notices of positions available and wanted, are published free of charge for a
maximum of three weeks for ABC institutional members. There are charges for non-members: $114 per placement
for ABC Newsletter subscribers and $279 for non-subscribers. Notices ordinarily are limited to 150 words. To place
an ad, contact Deanna Du Lac at the ABC office. Phone: (202) 654-2917; fax: (202) 393-5527; e-mail:
[email protected].
Blood Banking/Transfusion Medicine Physician. New
York Blood Center (NYBC) seeks a full-time blood banking/ transfusion medicine physician for an open position as
transfusion service medical director at Westchester Medical Center. NYBC is one of the nation’s largest non-profit,
community based blood centers supplying 400,000 red cell
units to New York, New Jersey, and Pennsylvania. In
addition to its core function as a premier collector, processor, and distributor of blood and blood products, NYBC is
also home to the Lindsley F. Kimball Research Institute
and the National Cord Blood Program at the Howard P.
Milstein National Cord Blood Center which is the world’s
single largest public cord blood bank. Westchester Medical
Center is a large tertiary care hospital with specialty services in trauma, burn, pediatrics, stem cell transplantation,
solid organ transplantation, cardiac surgery and hematology/oncology. This individual would be an integral
member of Medical Programs and Services Division of
New York Blood Center, which encompasses hemophilia
services, transfusion services, therapeutic apheresis, National Marrow Donor Program, transfusion medicine
fellowship, cellular therapy, perioperative autologous
transfusion as well as medical oversight of the entire organization. Under the leadership of Dr. Beth H. Shaz, Vice
President of Medical Programs and Services and Chief
Medical Officer, with the support of Dr. Christopher D.
Hillyer, President and Chief Executive Officer, this division is undergoing transformation to provide innovative,
high quality service and products. Candidates should have
a MD +/- PhD, eligibility for medical licensure in New
York, eligibility for board certification in blood banking/transfusion medicine, and strong management,
communication and leadership skills. Ample time for
scholarly activities as well as a faculty appointment will be
provided. Please send letter of interest, current CV and
contact
information
for
three
references
to
[email protected]. NYBC is committed to Equal
Opportunity and Diversity. Women, veterans, members of
underrepresented minority groups and individuals with
disabilities are encouraged to apply.
Medical Director. The South Texas Blood & Tissue Center (STBTC), San Antonio, Texas, seeks a physician
primarily responsible for medical oversight and strategic
development of STBTC’s clinically oriented services,
including clinical consultation, strategic medical support of
clients, autologous and directed donations, Reference Lab,
NMDP/PBSC collection and Cord Blood collection. Additionally, provide scientific and medical direction to support
high-quality blood and components, laboratory testing,
donor collections and counseling, product management,
clinical diagnostics and quality assurance. Qualifications:
Medical physician, board certified or eligible, in clinical
pathology or hematology and blood banking/transfusion
medicine certification preferred. Must be certified to practice medicine in State of Texas. Minimum of two years
experience in blood banking or transfusion medicine. Two
years management experience preferred. Outstanding
public presentation and computer skills required. For information, please contact Human Resources at (800) 2925534 and speak to Sandra Munoz, ext. 1544, or Rebecca
Madere, ext. 1111, or e-mail resume to either
[email protected]
or
[email protected].
Vice President – Laboratory Services. Our client, Community Blood Center Inc., is an independent, local, not for
profit organization located in Appleton, Wis. They have
been providing blood and blood component products since
1955. They are committed to providing the highest quality
blood products and professional blood services at the lowest practical cost to hospitals and patients they serve. The
Vice President of Laboratory Services is responsible for all
personnel, procedures, technology, supplies, and functions
associated with donor testing, components manufacturing,
product deliveries, and the reference lab. This position
reports to the President/CEO and is responsible for 20
employees. We require an MT (ASCP) SBB or extensive
technical experience Appleton offers outstanding quality of
life with excellent educational and recreational opportunities, as well as low cost of living. Contact: Susie Anshus,
Flannery and Associates LLC, N27 W23953 Paul Road,
Suite
204,
Pewaukee,
WI
53072;
e-mail:
[email protected]; phone: (262) 523-1206.
Clinical Laboratory Scientist III – Blood Bank. Under
general direction of Blood Bank Supervisor and/or CLS
V(s), position will assume responsibility for functioning
blood bank as well as act as a technical resource and provide team leadership to staff working in assigned area. CLS
must possess appropriate skills and theory necessary to
perform variety of specialized testing and act as technical
resource and leader in and assigned area/shift. CLS will
evaluate new methodologies, reagents, and instrumentation
and perform validations as needed. Also responsible for
writing new procedures and will actively participate in
review, revision, and implementation of section SOPs.
Under direction of Lab Management, CLS will assist with
administrative duties as necessary, such as staff scheduling
and inventory control of reagents and supplies. As part of
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POSITIONS (continued from page 29)
Lab team, CLS must perform accurate and precise work
with consistently low error rate while maintaining awareness of sectional needs and contributing one’s skills and
abilities to meet those needs. Monitor and review quality
control documentation following established schedules and
ensure QC is performed on schedule. Must actively participate in internal and external continuing education programs
to keep abreast of current practices and act as technical
resource by sharing skills and knowledge with staff. Provide leadership for troubleshooting, equipment
maintenance, training needs, and new development. Associate’s degree with MLT (ASCP)/HT (ASCP), or
equivalent in education and clinical laboratory experience
required with five years’ laboratory experience (as CLS I/II
or comparable position) or bachelor’s degree with MT
(ASCP)/HTL (ASCP) or equivalent in education and
clinical laboratory experience required with three years
laboratory experience (as CLS II/III or comparable position). Full time 36-39 hours - 7:30 a.m. to 3:00 p.m. Full
time 40 hours - 1:30 p.m. to10:00 p.m. DartmouthHitchcock Medical Center, located in Lebanon, N.H., on
the Vermont/New Hampshire border, is New Hampshire’s
only integrated, academic medical center and Level I
trauma center. Home to Dartmouth College, the Lebanon/Hanover area is a vibrant academic and professional
community offering excellent schools, lively arts, and
unmatched quality of life in a beautiful, rural setting.
Dartmouth-Hitchcock Medical Center includes a modern
400-bed tertiary care hospital, research and clinical facilities for Dartmouth Medical School, Norris Cotton Cancer
Center, and Dartmouth-Hitchcock Clinic. In addition, we
have been consistently rated one of America’s Best Hospitals by US News and World Report. At DartmouthHitchcock Medical Center, Life Works Here. Applicants
are encouraged to apply online at www.dhmc.org. EOE
Donor Recruitment Representative. Responsible for
developing and building long-term collaborative relationships with new organizations, while maintaining ongoing
involvement with existing sponsor organizations to foster
ongoing blood drives. Position requires outgoing selfstarter and motivated independent decision maker with
ability to achieve goals through effective donor recruitment
and territory account and calendar management. Minimum
qualifications and requirements include Bachelor’s degree
and/or three to five years marketing/sales experience with
territory management skills where established goals were
attained and surpassed; effective presentation, oral and
written skills; self-motivated and self starter with excellent
organizational skills; flexible to work weekends and evenings as necessary; dependable transportation with Nevada
driver license and clean driving record. We offer competitive compensation package that includes health, dental,
vision, pension, 401 (k) plan and much more. If your education and experience meet these qualifications, please
apply at www.UnitedBloodServices.org. Two full-time
positions open. EOE/M/F/D/V
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January 7, 2011
Donor and Patient Services Director (#493). Inland
Northwest Blood Center, located in the beautiful Pacific
Northwest, is seeking a full-time Donor and Patient Services Director to provide leadership for and ensure the
integrity/compliance of the donor and patient services of
INBC, to include donor collections, therapeutic services
and NMDP. Oversee the direction, coordination, and
evaluation of these departments, providing direction for
subordinate management team members to ensure excellent
services and an adequate, safe, pure, and potent blood
supply; bachelor’s degree in Nursing, Healthcare Management, or Business; or equivalent combination of
education/related professional training. Master degree in
Healthcare or Business preferred; eight years’ progressively responsible experience in a blood center, health-care
or other relevant environment; with a minimum of five
years’ proven experience in positive management of multiple direct reports; ability to lift up to 25 pounds
occasionally. Complete position description available upon
request (800) 423-0151 x 4247. Competitive compensation/benefits package; applicants must send/fax a
completed INBC Application Attn: Human Resources,
INBC, 210 W Cataldo Ave, Spokane WA 99201; fax:
(509) 232-4530; position open until filled. Applications are
available on our website at: www.inbcsaves.org EEO/AA
Director of Quality Assurance and Regulatory Affairs.
Memorial Blood Centers has an immediate opening for a
Director of QRA. This position is a vital member of our
management team and will lead, manage, and routinely
evaluate quality and regulatory operations throughout the
organization. Foster an environment of integrity, partnership, leadership and commitment expected from everyone
in the organization. Exercise a leadership and management
style that promotes appropriate initiative and creates
growth opportunities for all personnel. Implement strategic
initiatives in the quality assurance department; develop and
promote opportunities for personnel to offer creative solutions to challenges. Also required is the ability to monitor
and evaluate compliance to Federal regulations and standards throughout the organization. The successful
candidate will have advanced academic preparation in
transfusion medicine or kindred field that meets the technical requirements of this position; sufficient working
knowledge of internal and regulatory agency compliance
standards to serve as the organization’s Director of Quality
and Regulatory Affairs.; at least 10 years experience, several of which must have included functional supervision,
management and regulatory experience. Clearly demonstrated leadership skills. Excellent writing / communication
skills and the ability to effect desired results in a varied
environment of changing priorities. AABB assessor status
is preferred. To apply: please go to www.mbc.org.
Medical Director. Our client, Community Blood Center
Inc., is an independent, local, not for profit organization
located in Appleton, Wis. They have been providing blood
and blood component products since 1955. They are committed to providing highest quality blood products and
(continued on page 31)
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POSITIONS (continued from page 30)
professional blood services at lowest practical cost to the
hospitals and patients they serve. The Medical Director is
responsible for all quality, system, medical and technical
policies, processes and procedures, including those that
relate to laboratory personnel and test performance, and for
consultative and support services that relate to the care and
safety of donors and/or transfusion recipients. The Chief
Medical Officer reports directly to the President/CEO of
Community Blood Center Inc. Appleton offers an outstanding quality of life with excellent educational and
recreational opportunities, as well as a low cost of living.
Contact: Peter Flannery, Flannery and Associates LLC,
N27 W23953 Paul Road, Suite 204, Pewaukee, WI 53072;
e-mail: [email protected]; phone: (262) 5231206.
Section Supervisor – Blood Bank. Supervisor of blood
bank has responsibility for operational oversight of Blood
Bank/Transfusion Service and works in collaboration with
Blood Donor Program and Cellular Therapy Center within
Transfusion Medicine Service. Demands of this role require professional who is self-directed, motivated, and
flexible, and also possesses excellent interpersonal skills.
Ideal candidate must be Registered Medical Technologist
with a minimum of five years of laboratory experience,
including two years in supervisory or lead position. Advanced degree and/or specialty examination for appropriate
section preferred. Dartmouth-Hitchcock Medical Center,
located in Lebanon, N.H., on the Vermont/New Hampshire
border, is New Hampshire’s only integrated, academic,
Level I trauma center. Home to the prestigious Ivy League
Dartmouth College, the Lebanon/Hanover area is a vibrant
academic and professional community offering excellent
schools, lively arts, and unmatched quality of life in a
beautiful, rural setting. Dartmouth-Hitchcock Medical
Center includes a modern 400-bed tertiary care hospital,
research and clinical facilities for Dartmouth Medical
School, Norris Cotton Cancer Center, and DartmouthHitchcock Clinic. In addition, we were the first hospital in
New Hampshire to receive Magnet status and have been
consistently rated one of America’s Best Hospitals by US
News and World Report. Full-time, 40 hours, 8:00 a.m. to
4:30 p.m. At Dartmouth-Hitchcock Medical Center, Life
Works Here. Applicants are encouraged to apply online at
www.dhmc.org. EOE
Donor Center Manager. Kentucky Blood Center, located
in Lexington, Kentucky seeks enthusiastic healthcare
professional to hire, train, motivate, encourage, develop,
evaluate, and supervise on-site and mobile collection staff
to ensure our valued volunteer blood donors receive the
best care possible; ensure quality control and compliance
with industry regulations; utilize resources to maximize
cost effectiveness; and assure beneficial business relationships in the community. Medical background (RN, MT,
MLT, or related field) and five years management experience required. Applicants must have working knowledge
of Word and Excel; demonstrated skills in staff management/development, budget preparation/monitoring, and
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January 7, 2011
organizational skills; ability to think independently and
solve problems; and possess excellent communication
skills. This challenging opportunity requires a team-player
attitude, high energy level, and a dedication to excellence.
Applications must contain a cover letter to be considered.
Benefits: Medical Insurance, Life Insurance, Dental Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, Long
Term Disability, 401K/403b Plan, Pension/Retirement.
Screening Requirements: Drug Screen, Criminal Background Check. For more information or to apply online
please visit: http://www.kybloodcenter.org/. Drug-free and
EOE/AAP
Positions at The New York Blood Center:
The New York Blood Center has provided our community
with the highest quality transfusion products and services,
as well as leading-edge research, technological and medical
care innovation, and education in the field of transfusion
medicine for over 40 years. As the nation's largest community-based, non-profit, independent blood center our
employees play a vital role in making the New York Blood
Center a center of excellence where all activities, people,
products, processes and service surpass expectations and
are aimed at earning and keeping the trust and confidence
of all stakeholders
Director, Cord Blood Quality, Long Island City location.
Provide oversight, support and guidance in quality and
regulatory issues to the National Cord Blood Program.
Oversee Quality Requirements in all National Cord Blood
Program areas. Manage National Cord Blood Program
processes to meet FDA cGMP and FACT standards. Function as the liasion with the corporate internal auditor
program. Responsible for making recommendations and
monitoring current and future standards and implementing
training, procedures and practices. Requirements: bachelor’s degree (minimum) with masters desirable. Experience
with six sigma or equivalent, preferred. 10 years experience in quality in a regulated environment, with five years
of management experience in quality. Experience with cell
manufacturing required. Experience in the preparation and
filing of Biological Licenses Applications helpful. Detail
oriented. Excellent communication skills required. Working knowledge of prevailing laws and regulatory
requirements, cGMP and international standards. To apply,
please
e-mail
your
resume
to:
[email protected].
Quality Assurance Specialist, Long Island, New Jersey,
Westchester, Manhattan locations. Provide guidance,
support and oversight to operations and other functional
groups within New York Blood Center. Support and assist
management in the Quality & Regulatory Affairs division
in all activities related to compliance monitoring, Standard
Operating Procedure (SOP) review and continuous improvement. Under the guidance of direct supervisor work
to ensure that specific assigned region of NYBC is compliant. Cooperate with auditors as needed. Requirements:
bachelor's degree required, preferably in biological sci
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January 7, 2011
POSITIONS (continued from page 31)
Quality Systems, and cGMP’s. To apply, please e-mail
your resume to: [email protected].
ences or comprable education/experience combination.
Working knowledge of regulations and standards applicable to blood and tissue establishments. Minimum one year
experience in blood banking, transfusion services, biologics, etc. Minimum two years experience in Quality related
activities. Experience in conducting audits, desirable.
Excellent written and oral communication skills. Attention
to detail. Able to conduct limited travel when necessary
Ability to think critically and make decisions related to
compliance within the blood establishment Ability to
perform root cause analysis. To apply, please e-mail your
resume to: [email protected].
Data Analyst, NYC. Assists Quality and Regulatory Affairs and Operations in collection and analysis of quality
data to determine opportunities for improvement and to
generate actionable reports. To provide guidance and data
management support to quality and operations in the appropriate collection and analysis of data. Requirements:
Baccalaureate degree required in analytical background.
One to two years experience in processing data preferred.
Advanced knowledge and significant experience with
Microsoft Excel, Microsoft Access and PowerPoint required. Strong analytical skills; ability to create
presentations that accurately depict data; excellent verbal
and written communication skills. Experience with statistical process control experience, very desirable. To apply,
please
e-mail
your
resume
to:
[email protected]. As an Employer of
choice, New York Blood Center offers an environment that
supports and sustains the needs of employees. We understand the demands of your career, your need for
autonomous decision-making, and your desire to keep
learning. Below are just a few of the Benefits we offer to
our employees. Health benefits: comprehensive medical,
prescription drug, and vision plans employer contribution
of 7 percent of base salary to a 403(b) Retirement Account;
tuition; reimbursement program; medical and dependent
care flexible spending accounts; commuter administration
services (pre-tax commuter savings account) (CAS). For
more information about our company and its benefits
please visit us at: www.nybloodcenter.org. The New York
Blood Center is committed to equal opportunity and diversity. Women, veterans, members of underrepresented
minority groups and individuals with disabilities are encouraged to apply.
Regulatory Affairs Associate, NYC Location. Assist
Director of Regulatory Affairs in the following areas:
Preparation/submission of electronic Biological Product
Deviation Reports. Preparation/submission of Biologic
License Application submissions and state applications and
renewals. Tracking status and submission of responses to
FDA/state/AABB/other deficiencies and citations. Review
of regulatory information to update DRA on developing
issues and regulatory requirements. Requirements: bachelor’s degree, advanced degree preferred. Three to five years
experience in Regulatory Affairs including preparation of
required regulatory submissions, is preferred. Thorough
demonstrated knowledge of federal, state, AABB regulations and standards as they apply to blood center and
HCT/P activities. Three to five years experience in blood
establishment quality is desirable. Detail oriented. Attention to accuracy. Excellent communication skills, both
verbal and written. Ability tointeract with others in a calm,
professional manner. Thorough working knowledge of
basic computer programs. Word/Excel/PowerPoint essential. To apply, please e-mail your resume to:
[email protected].
Document Management Specialist, NYC, Long Island
City. Assures that Regulatory, Compliance, and Organizational goals are met by managing the official NYBC
corporate documents consisting of, but not limited to,
Standard Operating Procedures (SOP’s), Policies and
Directives, Training Manuals. Manages electronic posting
of documents and ensures documents meet corporate
document and graphics standards and are current, accurate,
and accessible. Requirements: Two-year associate’s degree from an accredited institution or equivalent is
required. A minimum of two years of experience in an
FDA regulated environment is required. Training and/or
experience in a Laboratory is preferred. Quality Assurance
experience or keen interest (demonstrated by self acquired
knowledge or courses) is required. Demonstrated interpersonal skills and Customer Service focus is required. Must
be detail oriented. Must have sound decision-making skills
and be able to recognize and resolve most common problems. Must have the ability to handle multiple tasks at one
time. Must be proficient in Microsoft software applications,
including Word, Excel, and Access; Trackwise and Pulse.
Must have a basic understanding of FDA regulations,
Director of Donor Services. Blood Bank of Delmarva
seeks a Director of Donor Services to function as a key
member of senior leadership overseeing all activities associated with the collection of blood products throughout the
Delmarva Peninsula. In addition to blood collection operations, individual will be responsible for internal and
external relationship building, financial management,
performance management, building department teamwork,
staff development, and regulatory compliance. Candidates
should possess a Bachelor degree in Nursing, Medical
Technology, related healthcare field or organizational
management. Master’s degree is preferred. The ideal
candidate will possess 10 years of leadership experience
with at least five years of demonstrated experience in
strategic planning and employee development, as well as
process improvement. Blood Banking, hospital or healthcare experience is a plus. Interested applicants may apply
through www.Careerbuilder.com.
Clinical Lab Scientist. Perform high complexity testing of
biological specimens and reviews test results in a blood
bank setting. Must be detail oriented w/strong analytical
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POSITIONS (continued from page 32)
\skills. FT or PT, mid-day shift w/some weekends and
occasional on call. Valid CA CLS license required. Mail
resume to: Human Resources, United Blood Services,
4119 Broad Street, Ste 100, San Luis Obispo, CA 93401;
website: www.unitedbloodservices.org. Close date:
1/21/11. EOE/ M/F/D/V
Transfusion Medicine Fellowship. Open July, 2012,
presented by the University of California Davis in partnership with BloodSource. Intensive program includes
transfusion and apheresis services, donor center operations,
Immunohematology reference laboratory, coagulation, and
HLA laboratories. Elective stem cell research is available.
Pathology applicants should have completed either a combined AP/CP residency or a CP residency. Applicants may
also have internal medicine, anesthesiology, surgery or
other residencies by the American Board of Pathology.
Please send letter of interest, CV, and three letters of recommendation addressed to Carol Marshall, MD, Director
BB/TM Fellowship, to Penny Young, Fellowship and
Residency Training Program Coordinator, Department of
Pathology/Laboratory Medicine, University of California,
Davis Medical Center, 4400 V Street, PATH Building,
Sacramento,
California
95817
or
e-mail:
[email protected]. For more information
see our websites: http://ucdmc.ucdavis.edu/pathology and
http://www.bloodsource.org/.
Medical Director. United Blood Services of Arizona seeks
a motivated physician trained in Transfusion Medicine to
fill the role of Medical Director. This position reports to the
Senior Medical Director. Responsibilities include medical
and technical leadership to blood center operations, medical consultation to hospital staff and clinicians, delivery of
lectures and other didactics for local medical training programs, and medical oversight of autologous and therapeutic
collections. Other responsibilities may include duties
through Blood Systems Medical Affairs or staff appointments with local hospital transfusion services. Board
certification in Clinical Pathology, Internal Medicine or
Pediatrics required. Board certification/board eligibility in
Blood Banking/Transfusion Medicine required. Competitive salary and benefits with relocation assistance available.
Send CV to: [email protected] or by
mail to RSW, United Blood Services of AZ, 6220 East
Oak Street, Scottsdale, AZ 85257. Fax: (480) 675-5448.
EOE M/F/D/V
Director of Hospital Services. Kentucky Blood Center,
located in Lexington, KY is seeking a resourceful, selfmotivated individual to oversee all administrative and
technical aspects of our Hospital Services department. The
successful candidate will ensure excellent customer service
is provided to all KBC blood component customers; complete the department operational budget; monitor expenses
and provide variance reports to CTO; review staff performances annually according to policy; ensure all audits
and reviews are completed in a timely manner and will
ensure acceptable validation and implementation of new or
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January 7, 2011
revised processes, equipment, computer programs and
SOPs. Certification Requirements: – MT (ASCP). Candidates must have a college degree (Business, Management
or Administration preferred), be MT (ASCP) certified and
have at least five years management experience. Applications must contain a cover letter to be considered. Benefits:
Medical Insurance, Life Insurance, Dental Insurance, Paid
Vacation, Paid Sick Days, Paid Holidays, Long Term
Disability, 401K/403b Plan, and Pension/Retirement.
Screening Requirements: Drug Screen and Criminal Background Check. For more information or to apply online
please visit: http://www.kybloodcenter.org/. Drug-free &
EOE/AAP
Donor Care Manager. United Blood Services located in
Billings, MT has an exciting Management opportunity in
our Donor Care Department. This position will provide
leadership and direct oversight to the daily operational
activities of the mobile blood collections department and
will be responsible for off-site blood draw. The Billings
mobile staff performs Haemonetics Double Red and Whole
Blood phlebotomy procedures and has an annual RBC
collection of approximately 30,000 units. Successful candidate will have excellent leadership and communication
skills, proven performance management skills, training
talents and have exceptional customer service abilities.
Management style must reflect calm, steady and organized
approaches to establishing team spirit, emphasizing quality
of life, and setting the standard of compliance for excellence. Bachelor’s Degree plus 3 years related experience
with at least two years supervisory experience (prefer
healthcare-related) or at least seven years directly related
healthcare supervisory experience, preferably some blood
center supervisory. Billings is the main community center
for UBS Rocky Mountain Region which is comprised of
four locations in Montana and Wyoming. Billings is our
largest community center for the region and is located in
south-central Montana. Additionally, UBS Rocky Mountain has a second community center in Cheyenne,
Wyoming and draw centers in Butte, Montana and Casper,
Wyoming. We employ approximately 130 staff members
and provide lifesaving blood to approximately 50 community hospitals in Montana and Wyoming. We see growth
potential and professional opportunities in our future and
encourage applicants who want to achieve their potential
by helping us reach ours. UBS offers an excellent benefit
package, competitive salary and relocation assistance. Our
team is committed to excellence. To join our team and
make a difference, submit a resume, cover letter and salary
history to Human Resources Director, United Blood Service, 1444 Grand Ave., Billings, MT 59102; fax (208)
379-9500; e-mail: [email protected]. All offers of
employment are contingent upon favorable preemployment drug screen and Motor Vehicle Reports, as
well as acceptable background checks to include criminal
history and employment history verified through HireRite.
UBS confirms work eligibility by Form I-9 and by participating in E-Verify. Application Deadline: Feb. 04, 2011.
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POSITIONS (continued from page 33)
Blood Bank Educator. We are currently seeking a dynamic laboratory education professional to develop
programs that promote and enhance the knowledge base of
the Transfusion Service (TS) staff related to Immunohematology theory and its practical application. The TS
Laboratory employs more than 100 full-time staff working
in five labs in the metropolitan Seattle area. The educator
will provide guidance for laboratory bench trainers, participate on project work teams and serve as a mentor for
individual staff members seeking blood banking certifications. The educator will collaborate with supervisors and
bench trainers to develop robust training plans that incorporate theory and critical thinking. The skill and ability to
utilize emerging on-line technologies to increase employee
engagement and their desire to learn would be a plus.
Requirements include: Bachelor of Science degree in
clinical laboratory science or other biological science;
laboratory certification of Medical Technologist (MT) or
Clinical Laboratory Scientist (CLS); Specialist Blood
Banking (SBB) certification strongly preferred; minimum
of two years immunohematology laboratory experience;
two years experience in teaching at the baccalaureate
medical technology level or equivalent. Additional skills
include demonstrated proficiency with Microsoft Office
applications including Word and PowerPoint experience;
demonstrated leadership skills including relationship building, assertiveness, self-awareness and self-confidence;
ability to function effectively within the team and participate and contribute constructively to produce results in a
collaborative manner. Exceptional verbal and written
communication is essential for success in this position. Our
competitive compensation package includes generous
flexible benefits program including medical, dental, vision,
life insurance, LTD, Flexible Spending Accounts, commuter benefits, 403(b) retirement plans with company-paid
contributions up to 10%, 24 days of Paid Time Off during
first year, Extended Illness leave, etc. The hourly rate for
this non-exempt position is grade (N). Qualified applicants
please send resumes to: Human Resources, Job
#6317ABC – Internal Educator, Puget Sound Blood
Center, 921 Terry Ave, Seattle, WA 98104-1256, or via email to [email protected]. This position is fulltime, based at our Seattle - First Hill location. Position
open until filled. As a recognized leader in transfusion
medicine, the blood center operates the world’s largest
Transfusion Service, which serves patients in more than 70
hospitals and 21 clinics in Western Washington. Join our
team and make a difference! The Puget Sound Blood
Center is an EEO/AA employer dedicated to workforce
diversity.
Systems Specialist – Transfusion Medicine. Make a
difference, get noticed and build a highly rewarding career
at City of Hope! We’re an innovative biomedical research,
treatment and educational institution dedicated to the prevention and cure of cancer and other life-threatening
illnesses. In this unique opportunity, you will bring together both the clinical and technological aspects of
transfusion medicine. Working with a strong management
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January 7, 2011
team, you will oversee the operations of our Transfusion
Medicine information systems and data management. You
will also insure compliance with applicable regulations and
standards related to blood establishment computer systems.
This position offers strong collaboration and support as
well as access to cutting-edge technology in our blood
transfusion and cellular therapy programs. We’re seeking a
Clinical Laboratory Scientist or Medical Technologist with
two years managing blood establishment computer systems
and five years experience in Blood Banking Project management. Join City of Hope as we create the optimum
environment to redefine the future of medical discoveries.
Please apply online at www.cityofhope.org/employment.
For questions contact Diana Herrera: [email protected].
City of Hope provides an environment of diversity, discovery and unlimited possibilities! An Equal Opportunity
Employer.
Technical Manager in Atlanta, Ga., and in Mobile, Ala. If
you are a Medical Technologist with experience in transfusion services or blood banking and have experience
managing, LifeSouth Community Blood Centers has an
immediate opening for you in either its Huntsville, Ala.,
location or in Mobile location. Both positions are responsible for managing production through components and
hospital services staff, with full accountability for costs,
methods, personnel, quality, inventory and distribution. If
you want to work for a stable, non-profit organization that
will allow you to grow and be challenged, then LifeSouth
has the position for you. As the Technical Manager, you
will work in a fast-paced, highly-structured work environment, where responsibilities shift frequently and the focus
is on high-quality and efficient results through intense
follow-up. Minimum qualifications and requirements
include: Bachelors of Science degree and MT (ASCP,
SBB) or equivalent certification; relevant experience in
transfusion services and/or laboratory blood banking and
health services management and/or supervisory experience.
The qualified candidate must be knowledgeable of FDA
and AABB standards and other regulatory requirement,
and have strong planning and process management skills.
We offer a competitive salary and comprehensive benefit
package, along with a stable work environment and unlimited professional growth opportunities. To learn more about
our openings and to apply, please visit www.lifesouth.org.
EOE/A A/DFWP
Staff Applications Scientist (Technical Manager for
Immunohematology). Beckman Coulter develops, manufactures and markets products that simplify, automate and
innovate complex biomedical testing. Our diagnostic systems are
found in hospitals and other critical care settings around the
world and produce information used by physicians to
diagnose disease, make treatment decisions and monitor
patients. Instruments for life science research are used by
scientists as they study complex biological problems including the causes of disease, identify new therapies, and
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POSITIONS (continued from page 34)
test new drugs. Our customers include hospitals, physicians´ offices, diagnostic reference laboratories,
pharmaceutical and biotechnology companies, universities,
medical schools and research institutions. In fact, Beckman
Coulter has more than 200,000 clinical and
research instrument systems operating in laboratories
around the world. Responsible for resolving customer
issues through direct contact, problem solving, analysis and
by providing technical expertise to sales and marketing.
Develops and
provides technical training to customers, serves as an integral part of product development, assists in critical account
management via interactions with customers and other
activities, participates in a variety of task force teams,
works with QA to disposition customer complaints, develops customer letters and product information notification
for customers and field employees. Position is also responsible for providing leadership to a team of application
scientists. A successful candidate will have a BS in Medical Technology (SBB preferred) and minimum five years
recent experience in Immunohematolgy. Experience with
international customers is preferred. Must have knowledge
of world-wide blood bank market and in-depth understanding of blood bank serology and test methods. Position
requires someone who has proven effective supervisory/management skills; the ability to analyze and solve
customer issues in a timely manner; proven organizational,
analytical, prioritization, problem solving, and project
management skills. Must be hands on and goal oriented
with the ability to work with a sense of urgency in a fastpaced multi-task environment. Requires minimum 25
percent Domestic/International travel. If you believe your
education and experience are in line with the position
description and qualifications referred to above, and are
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January 7, 2011
motivated, energetic, and looking for a new and exciting
opportunity, please submit your resume online to:
www.beckmancoulter.com. (Requisition number 78926).
EOE
Donor Relation Manager. The Donor Relations Manager
develops and leads a regional team of Donor Relations
Specialists to achieve annual blood collection goals in the
Saginaw, Midland, and Bay City areas. This position
works closely with the Director of Donor Relations to
develop and implement short and long term plans to
achieve the goals and objectives of Michigan Blood. This
individual will manage metrics and performance indicators,
provide ongoing analysis leadership for the team, and work
with team members to set specific, measurable and relevant
objectives. The Donor Relations Manager will conduct
ongoing assessments of specialists’ territories providing
coaching and identifying new strategies and tactics for
market development. This position requires strong leadership skills, in-depth knowledge of sales process, attention
to detail, and a demonstrated record of making and exceeding sales goals. A bachelor’s degree plus two years of
supervisory and sales experience are required. Excellent
communication and drive to succeed is a must. This position will involve frequent local travel. Dependable
transportation is required. Some evening and weekend
hours required. If you have a passion for the health field,
desire to be part of a growing Michigan company, and your
strength is connecting with others, please send resume and
cover letter to: Michigan Blood, Attn.: HR (ABC-153),
1036 Fuller NE, PO Box 1704, Grand Rapids, MI 495011704. Or visit www.miblood.org. EOE 6