South Texas Blood & Tissue Center to Get a New CEO
South Texas Blood & Tissue Center to Get a New CEO
South Texas Blood & Tissue Center to Get a New CEO
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
2010 #1 January 8, 2010<br />
INSIDE:<br />
Our Space: Five for 2010<br />
(and Beyond) ................ 2<br />
Florida Senate Issues<br />
Report on Community<br />
<strong>Blood</strong> <strong>Center</strong>s ............... 3<br />
<strong>Blood</strong> Bank Data<br />
Exchanges Part of<br />
‘Meaningful Use’ of<br />
Health IT, But Stimulus<br />
Act Funding Seems Only<br />
for Medicare, Medicaid<br />
Billers So Far ................ 4<br />
ABC’s Foundation Board<br />
Welcomes <strong>New</strong>est<br />
Members ...................... 6<br />
Qualtex Labora<strong>to</strong>ries Will<br />
<strong>Get</strong> a <strong>New</strong> Leader in<br />
Norman Kalmin, MD ..... 7<br />
Study: Presence of Strep<br />
Pneumonia Can Indicate<br />
H1N1 Infection Severity 8<br />
Studies Investigate the<br />
Link between Virus and<br />
Chronic Fatigue<br />
Syndrome ..................... 9<br />
<strong>New</strong> Guidelines Address<br />
Red <strong>Blood</strong> Cell<br />
Transfusions ............... 11<br />
Thank a Donor Web Site<br />
Connects <strong>Blood</strong> Donors<br />
and Recipients ............ 15<br />
HHS Official Recognizes<br />
National <strong>Blood</strong> Donor<br />
Month, Encourages<br />
Donations ................... 15<br />
<strong>South</strong> <strong>Texas</strong> <strong>Blood</strong> & <strong>Tissue</strong> <strong>Center</strong> <strong>to</strong> <strong>Get</strong> a <strong>New</strong> <strong>CEO</strong><br />
The <strong>South</strong> <strong>Texas</strong> <strong>Blood</strong> & <strong>Tissue</strong> <strong>Center</strong> (STBTC) on<br />
Wednesday announced that Kevin Land, MD, will<br />
take over as the center’s President/<strong>CEO</strong> and Medical<br />
Direc<strong>to</strong>r on July 1. Norman Kalmin, MD, will move<br />
from that position at STBTC <strong>to</strong> a similar role at Qualtex<br />
Labora<strong>to</strong>ries (see related s<strong>to</strong>ry, page 7).<br />
Dr. Land is currently the chief medical and scientific<br />
officer at Bonfils <strong>Blood</strong> <strong>Center</strong> in Denver, Colo.<br />
In a STBTC’s announcement of Dr. Land’s move, Dr.<br />
Anthony Infante, chair of the center’s Board of Direc<strong>to</strong>rs,<br />
praised him as bringing “a wealth of experience”<br />
<strong>to</strong> the center. He added that “Dr. Land’s clinical interests<br />
in transfusion medicine, cellular therapies, education, and patient safety are<br />
critical skills <strong>to</strong> bring <strong>to</strong> STBTC as the center continues growing <strong>to</strong> meet the needs<br />
of <strong>South</strong> <strong>Texas</strong> and the state. He is an excellent fit for STBTC as we move in<strong>to</strong><br />
this new era.”<br />
For his part, Dr. Land called STBTC “one of the premier centers for innovation<br />
in blood collection and services,” and he said that he “look[s] forward <strong>to</strong><br />
joining an already highly-skilled team.” He also praised his predecessor: “It<br />
is an honor <strong>to</strong> be following such a distinguished leader in transfusion medicine<br />
as Dr. Norman Kalmin.”<br />
His move <strong>to</strong> STBTC, which is headquartered in San An<strong>to</strong>nio, will be a sort of<br />
homecoming for him: he is a <strong>Texas</strong> native who earned his bachelor’s degree in<br />
biochemistry from the University of North <strong>Texas</strong> in Den<strong>to</strong>n, completed his medical<br />
degree at the University of <strong>Texas</strong> <strong>South</strong>western Medical <strong>Center</strong> in Dallas, and<br />
fulfilled his residency in ana<strong>to</strong>mic and clinical pathology at Parkland Memorial<br />
Hospital in Dallas.<br />
He moved <strong>to</strong> Maryland for a fellowship in medical informatics at Johns<br />
Hopkins University in Baltimore, but he returned <strong>to</strong> Dallas for a fellowship<br />
in transfusion medicine at Parkland and Carter <strong>Blood</strong>Care.<br />
Dr. Land’s next positions were as medical direc<strong>to</strong>r of <strong>Blood</strong> Systems Labora<strong>to</strong>ry<br />
in Bedford and medical direc<strong>to</strong>r of labora<strong>to</strong>ry services for Carter. He also served<br />
(continued on page 7)
ABC <strong>New</strong>sletter -2- January 8, 2010<br />
OUR SPACE<br />
By ABC <strong>CEO</strong> Jim MacPherson<br />
Five for 2010 (and Beyond)<br />
The last issue of the ABC <strong>New</strong>sletter featured the Top 10 S<strong>to</strong>ries of 2009. With the <strong>New</strong> Year we present more<br />
forward-looking trends.<br />
1. After a decade of shortages from mad cow and malaria deferrals and many millions invested in donor<br />
recruitment, the US blood supply is its most robust in decades. That’s good for patients and disaster preparedness,<br />
but hard on centers whose business model includes exporting blood <strong>to</strong> centers that could not<br />
meet their own needs. The current condition may be temporary, because in the long term, the future is increased<br />
blood use by aging boomers, especially for aggressive cancer therapy. Also, increased health<br />
insurance likely means more elective surgeries.<br />
2. At a time when blood centers have never been leaner and blood center margins are the lowest in a decade,<br />
a good supply is spawning competition for donors and hospitals. For threatened blood programs, it is<br />
about survival and maybe relevance. For hospitals, it is about short-term savings. Competition makes<br />
community blood suppliers look more nationally for markets and partners.<br />
3. For many, value-added service is an antidote <strong>to</strong> competition. Part of it involves hospitals outsourcing<br />
supply-chain functions <strong>to</strong> blood centers and part involves blood centers providing hospitals unique and<br />
cost-effective services that hospitals would be hard pressed <strong>to</strong> provide for themselves. The list is long,<br />
starting with a ubiqui<strong>to</strong>us blood supply, and it now includes managing hospital blood inven<strong>to</strong>ries and<br />
usage. Value-added service begins when mutually dependant entities recognize that hospitals are all about<br />
patient care and blood centers are all about blood.<br />
4. <strong>Blood</strong> safety is now presumed; the argument shifts <strong>to</strong> what adds value. Call it the “Chagas effect” (spending<br />
$100 million annually with an unknown benefit), but leukoreduction costs three times as much, still<br />
with no defined benefit. Lots of good discussion right now on the cost-benefit balance, but no answers yet.<br />
5. Finally, in building the best-next-HIV-mousetrap, regulation is now the biggest barrier <strong>to</strong> innovation and,<br />
ironically, blood safety. FDA is not the problem – it is merely a reflection of a risk-adverse society – but it<br />
also is not the solution.<br />
Happy <strong>New</strong> Year!<br />
Jmacpherson@americasblood.org <br />
The ABC <strong>New</strong>sletter (ISSN #1092-0412) is published 46 times a<br />
year by America’s <strong>Blood</strong> <strong>Center</strong>s® and distributed by e-mail.<br />
Contents and views expressed are not official statements of ABC<br />
or its Board of Direc<strong>to</strong>rs. Copyright 2010 by America’s <strong>Blood</strong><br />
<strong>Center</strong>s. Reproduction of the ABC <strong>New</strong>sletter is forbidden unless<br />
permission is granted by the publisher. (ABC members need not<br />
obtain prior permission if proper credit is given.)<br />
ABC is an association of not-for-profit, independent community<br />
blood centers that helps its members provide excellence in<br />
transfusion medicine and related health services. ABC provides<br />
leadership in donor advocacy, education, national policy, quality,<br />
and safety; in finding efficiencies for the benefit of donors,<br />
patients, and healthcare facilities; by encouraging collaboration<br />
among blood organizations; and by acting as a forum for sharing<br />
information and best practices.<br />
America’s <strong>Blood</strong> <strong>Center</strong>s<br />
President: Thomas Schallert<br />
Chief Executive Officer: Jim MacPherson<br />
ABC <strong>New</strong>sletter Edi<strong>to</strong>r: Robert Kapler<br />
Managing Edi<strong>to</strong>r: Anne Carroll, PhD<br />
Classified Advertising Manager: Deanna Du Lac<br />
Annual Subscription Rate: $372<br />
(Residents, Fellows and SBB Students: $120)<br />
Send subscription queries <strong>to</strong>:<br />
ddulac@americasblood.org<br />
America’s <strong>Blood</strong> <strong>Center</strong>s<br />
725 15th St NW, Suite 700, Washing<strong>to</strong>n, DC 20005<br />
Tel: (202) 393-5725<br />
Send news tips <strong>to</strong>: newsletter@americasblood.org
ABC <strong>New</strong>sletter -3- January 8, 2010<br />
Florida Senate Issues Report on Community <strong>Blood</strong> <strong>Center</strong>s<br />
The Florida Senate last month issued a report on blood bank regulation and activities in that state. The 15-<br />
page report details the results of a Senate review that followed a series of newspaper articles about board<br />
activities, <strong>CEO</strong> compensation, and donor incentives at the second- and third-largest blood centers in the<br />
state: Florida’s <strong>Blood</strong> <strong>Center</strong>s and Community <strong>Blood</strong> <strong>Center</strong>s of <strong>South</strong> Florida.<br />
As part of the review, staff from the Senate Committee on Health Regulation looked at market competition<br />
between blood banks and the fac<strong>to</strong>rs that play in<strong>to</strong> blood component pricing, “from the perspective of<br />
safeguarding the public health and minimizing the opportunities for fraudulent or harmful activities in this<br />
industry.” It also addressed <strong>CEO</strong> compensation, donor incentives (including scholarship programs), resource<br />
sharing, corporate governance, and issues related <strong>to</strong> blood centers’ role as drug wholesalers.<br />
Senate staff gleaned much of the information from interviews with blood center officials and survey questionnaires<br />
submitted <strong>to</strong> blood centers across the state. America’s <strong>Blood</strong> <strong>Center</strong>s was among the<br />
organizations contacted as part of the review process.<br />
While the report concludes that the community blood center model works <strong>to</strong> provide an<br />
adequate supply of safe blood in Florida, it suggests that “the industry in Florida would<br />
be well served” by improving competition and moni<strong>to</strong>ring “corporate complacency with<br />
respect <strong>to</strong> organizational activities and expenditures.”<br />
There are six not-for-profit corporations operating community blood centers in Florida: Community<br />
<strong>Blood</strong> <strong>Center</strong>s of <strong>South</strong> Florida, based in Lauderhill; Florida <strong>Blood</strong> Services, based in St. Petersburg;<br />
Florida’s <strong>Blood</strong> <strong>Center</strong>s, based in Orlando; Life<strong>South</strong> Community <strong>Blood</strong> <strong>Center</strong>s, based in Gainesville;<br />
Suncoast Communities <strong>Blood</strong> Bank, based in Sarasota; and The <strong>Blood</strong> Alliance, based in Jacksonville.<br />
One for-profit corporation, United States <strong>Blood</strong> Bank (USBB), is headquartered in Miami. Although the<br />
American Red Cross does not collect donations in Florida, it does provide blood products <strong>to</strong> some healthcare<br />
facilities in the state.<br />
The report details <strong>to</strong>tal revenues and net assets for all of the not-for-profit blood centers and addresses<br />
competitive pressures between centers. According <strong>to</strong> the report, 11 counties in the state have competing<br />
community blood centers. “The community blood center industry in Florida has experienced a his<strong>to</strong>ry of<br />
consolidation that has tended <strong>to</strong> more narrowly define operational terri<strong>to</strong>ries and reduce competition,” the<br />
report says.<br />
Senate staff recommends that the Florida Legislature pass laws <strong>to</strong>:<br />
<br />
<br />
<br />
Prohibit public agencies from restricting access <strong>to</strong> or use of public facilities or infrastructure<br />
based on the tax status of the community blood center (Edi<strong>to</strong>r’s note: This recommendation apparently<br />
stems from a situation in which USBB was notified by the Miami Parking Authority that<br />
meter rentals for blood mobiles will only be granted <strong>to</strong> non-profit companies);<br />
Prohibit a blood center from using the tax status of a hospital or other healthcare facility as the<br />
sole fac<strong>to</strong>r when determining the price at which it offers <strong>to</strong> sell or sells blood or blood components<br />
<strong>to</strong> the entity; and<br />
Address the “statu<strong>to</strong>ry obstacle” that prohibits a community blood center, because it is a healthcare<br />
entity, from maintaining licensure as a prescription drug wholesale distribu<strong>to</strong>r and engaging<br />
in the wholesale distribution of a prescription drug. “Florida’s laws should authorize the purchase<br />
and distribution of prescription drugs necessary for the safe delivery of healthcare services traditionally<br />
performed by community blood centers,” the report asserts.<br />
(continued on page 4)
ABC <strong>New</strong>sletter -4- January 8, 2010<br />
Florida Senate Report (continued from page 3)<br />
Among the report’s other recommendations is that community blood centers improve transparency concerning<br />
blood collection and distribution activities, which will increase public trust and “may help boost<br />
and maintain the level of voluntary donations, especially during traditionally low collection periods.”<br />
The report recommends that each blood center post disclosures in its facility or on its Web site that describe:<br />
<br />
<br />
<br />
<br />
Where the blood center distributes the blood it collects, such as <strong>to</strong> other states or regions, and its<br />
resource sharing activities with other blood centers that experience blood shortages;<br />
<strong>Blood</strong> center policies for related-party transactions and self-dealing. Those blood centers that<br />
have not amended related-party transactions should amend bylaws and other official documents<br />
addressing ethics and conflict of interest policies <strong>to</strong> require a competitive selection process prior<br />
<strong>to</strong> board approval of a related-party transaction;<br />
The identity of the members of the Board of Direc<strong>to</strong>rs and the compensation of officers, direc<strong>to</strong>rs,<br />
and key employees, and how <strong>to</strong> access that information on a timely basis. <strong>Blood</strong> centers should<br />
provide for a maximum length of service for a board member; and<br />
The process and costs involved in collecting, processing, and distributing donated blood, as well<br />
as the processing fees the community blood center charges <strong>to</strong> hospitals and other healthcare providers.<br />
A bill submitted <strong>to</strong> the Florida House of Representatives by Rep. John Tobia (R-District 31) last month<br />
would require blood centers in the state <strong>to</strong> submit annual financial reports, as well as information about<br />
the supply, sources, cost, pricing, and destination of blood products (see ABC <strong>New</strong>sletter, 12/18/09). A<br />
Senate hearing is scheduled for Jan. 13.<br />
This full report, “The Florida Senate: Review of the Regulation of <strong>Blood</strong> Banks,” is available at:<br />
www.flsenate.gov/data/Publications/2010/Senate/reports/interim_reports/pdf/2010-119hr.pdf. <br />
<strong>Blood</strong> Bank Data Exchanges Part of ‘Meaningful Use’ of Health IT, But Stimulus<br />
Act Funding Seems Only for Medicare, Medicaid Billers So Far<br />
Last week, two offices of the federal government released sets of federal regulations, <strong>to</strong>gether numbering<br />
nearly 700 pages, <strong>to</strong> implement the health information technology (HIT) section of the American Recovery<br />
and Reinvestment Act of 2009 (ARRA), better known as the Stimulus Act.<br />
The <strong>Center</strong>s for Medicare and Medicaid Services (CMS) on Dec. 30 issued a 532-page proposed rule<br />
listing the criteria that healthcare providers – eligible recipients at this point appear <strong>to</strong> be limited <strong>to</strong> Medicare<br />
and Medicaid billers – must meet <strong>to</strong> qualify for federal IT incentive funding based on how they use<br />
their electronic health records (EHRs). The same day, the Office of the National Coordina<strong>to</strong>r for Health<br />
Information Technology (ONC) issued an interim final rule laying out an initial set of standards and certification<br />
criteria for users <strong>to</strong> obtain those subsidies. ONC will also issue a notice of proposed rulemaking<br />
on the process for organizations <strong>to</strong> conduct the certification of EHR technology.<br />
America’s <strong>Blood</strong> <strong>Center</strong>s (ABC) successfully advocated for healthcare provider status for blood banks in<br />
the legislative language of Title XIII of ARRA, but its members have been stymied in their efforts <strong>to</strong> find<br />
a clear funding stream for IT projects at either the federal or state level.<br />
(continued on page 5)
ABC <strong>New</strong>sletter -5- January 8, 2010<br />
Meaningful Use Regulations (continued from page 4)<br />
CMS’s proposed rule makes no mention of blood centers. And while ONC’s interim final rule does mention<br />
the exchange of data between hospitals and “blood banks” as part of the certification criteria used <strong>to</strong><br />
support an eligible hospital’s claim for incentive payments <strong>to</strong> support its “meaningful use” of HIT, it still<br />
does not provide a clear pathway <strong>to</strong> ARRA funding for blood centers.<br />
CMS’s proposed rule is subject <strong>to</strong> a 60-day public comment period, after which HHS will issue final regulations.<br />
ONC’s EHR certification regulations take effect in 30 days; its comment period starts now and<br />
runs for 60 days. Final regulations will be published in 2010.<br />
ABC will file comments urging ONC and CMS <strong>to</strong> add language <strong>to</strong> the regulations that would enable<br />
blood centers <strong>to</strong> qualify for EHR incentive funding and other funding sources specified in Title XIII.<br />
ARRA, enacted Feb. 17, 2009, includes many measures intended <strong>to</strong> “modernize our nation’s infrastructure,<br />
enhance energy independence, expand educational opportunities, provide tax relief, and preserve and<br />
improve affordable healthcare.”<br />
Under the proposed meaningful use rules, eligible healthcare providers must use their<br />
EHRs <strong>to</strong> improve the quality, safety, and efficiency of healthcare services; reduce healthcare<br />
disparities; engage patients and their families; improve the coordination of care;<br />
improve population and public health; and ensure the privacy and security of personal<br />
medical information.<br />
Title IV of Division B of ARRA amends Titles XVIII and XIX of the Social Security Act <strong>to</strong> establish<br />
incentive payments <strong>to</strong> eligible professionals (EPs) and eligible hospitals <strong>to</strong> promote the adoption and<br />
meaningful use of interoperable HIT and qualified EHRs. These provisions, <strong>to</strong>gether with Title XIII of<br />
Division A of ARRA, are contained in the Health Information Technology for Economic and Clinical<br />
Health Act (HITECH Act).<br />
The HITECH Act creates incentives in the Medicare Fee-for-Service (FFS), Medicare Advantage (MA),<br />
and Medicaid programs for demonstrating meaningful EHR use and payment adjustments in the Medicare<br />
FFS and MA programs for not demonstrating meaningful EHR use. The HITECH Act appropriates $2<br />
billion <strong>to</strong> the ONC and codifies the duties of the national coordina<strong>to</strong>r, with the stated goal of “the utilization<br />
of an electronic health record for each person in the United States by 2014.”<br />
Section 13101 of the HITECH Act defines “certified EHR technology” as a qualified EHR that has been<br />
properly certified as meeting standards adopted under section 3004 of the Public Health Service Act.<br />
CMS and ONC say they “have been working closely <strong>to</strong> ensure that the definition of meaningful use of<br />
certified EHR technology and the standards for certified EHR technology are coordinated.” “Meaningful<br />
use” is a term <strong>to</strong> be ultimately defined by CMS and describes the use of HIT that furthers the goals of<br />
information exchange among healthcare professionals.<br />
In the upcoming interim final rule, ONC will identify the initial set of standards and implementation specifications<br />
that EHR technology must follow, as well as the criteria that will be used <strong>to</strong> certify EHR<br />
technology. A related proposed rule calls for the development of a certification program for health IT.<br />
“[W]e have sought <strong>to</strong> ensure that the definition of meaningful use of certified EHR technology does not<br />
require EPs and eligible hospitals <strong>to</strong> perform functionalities for which standards have not been recognized<br />
or established,” CMS said in its proposed rule.<br />
CMS’s proposed rule is available at www.modernhealthcare.com/assets/pdf/CH680921230.PDF. ONC’s<br />
interim final rule is available at www.modernhealthcare.com/assets/pdf/CH680931230.PDF.
ABC <strong>New</strong>sletter -6- January 8, 2010<br />
ABC’s Foundation Board Welcomes <strong>New</strong>est Members<br />
The Foundation for America’s <strong>Blood</strong> <strong>Center</strong>s (FABC) announced this week that Bart Fisher, PhD, and<br />
Patrick Hughes have joined its Board of Direc<strong>to</strong>rs. The two men, among their other accomplishments, are<br />
co-founders of the Give Life Foundation, which has been recognized as one of the nation’s leading blood<br />
advocacy groups and has partnered with the American Red Cross, ABC, AABB, and America Online <strong>to</strong><br />
raise national awareness for blood, tissue, and organ donation.<br />
Dr. Fisher is managing partner of the Law Office of Bart S. Fisher in Washing<strong>to</strong>n,<br />
DC. As principal of that firm, he has represented governments, corporations, and<br />
associations. He has worked on environmental and healthcare issues. His experience<br />
in healthcare began in 1984, when he was instrumental in securing passage of the<br />
National Organ Transplant Act, which laid the foundation for organ and marrow<br />
donation in the US. He has held many leadership positions, including president of<br />
the Aplastic Anemia and MDS International Foundation, which he founded in 1983;<br />
a board member of the National Marrow Donor Program (NMDP); chair of<br />
NMDP’s Public Policy Committee and Audit Committee; and member of the Board<br />
of Direc<strong>to</strong>rs of The Marrow Foundation. He currently chairs the Give Life Foundation. He has taught<br />
courses on international trade and investment at a number of universities since 1986, and he has written<br />
and edited many books and journal articles. Dr. Fisher earned his BA from Washing<strong>to</strong>n University; his<br />
MA and PhD from Johns Hopkins School of Advanced International Studies in Washing<strong>to</strong>n, DC, and<br />
Bologna, Italy; and his JD from Harvard Law School.<br />
Mr. Hughes is a pioneer in the fantasy sports industry, and he is the president and<br />
<strong>CEO</strong> of iTV Entertainment, LLC, which he founded with William Junkin in 2001<br />
and which develops interactive television games and applications. Mr. Hughes<br />
started his career in sales and marketing. After working for two Fortune 500 companies,<br />
he established Fantasy Sports Properties, Inc., which, in the years leading up <strong>to</strong><br />
the emergence of fantasy sports on the Internet, was the leading publisher of fantasy<br />
sports software and how-<strong>to</strong>-play books. He also created Fantasy Sports in the Classroom,<br />
an educational curriculum for high school teachers now in its tenth edition.<br />
For more than 10 years, he has been on the Fairfax County (Va.) Public Schools<br />
Marketing Advisory Board. He also is a member of the national advisory board for<br />
Distributive Educational Clubs of America (DECA), the nation’s oldest and largest association of marketing<br />
students. He earned his BS in marketing from the University of Maryland, and he has been a regular<br />
blood and aphaeresis donor the past 25 years. <br />
We Welcome Your Letters<br />
The ABC <strong>New</strong>sletter welcomes letters from its readers on any blood-related <strong>to</strong>pic that might be of<br />
interest <strong>to</strong> ABC members. Letters should be kept relatively short and <strong>to</strong> the point, preferably about a<br />
<strong>to</strong>pic that has recently been covered in the ABC <strong>New</strong>sletter. Letters are subject <strong>to</strong> editing for brevity<br />
and good taste. Please e-mail letters <strong>to</strong> ABC <strong>New</strong>sletter Edi<strong>to</strong>r Robert Kapler at rkapler@americasblood.org<br />
or fax them <strong>to</strong> (202) 393-1282. Please include your correct title and<br />
organization as well as your phone number. The deadline for letters is Wednesday <strong>to</strong> make it in<strong>to</strong> the<br />
next newsletter cycle.
ABC <strong>New</strong>sletter -7- January 8, 2010<br />
<strong>New</strong> <strong>CEO</strong> for STBTC (continued from page 1)<br />
UT <strong>South</strong>western’s medical school. He moved <strong>to</strong> Colorado in 2007 <strong>to</strong> become Bonfils’ first chief medical<br />
and scientific officer. In that position, he provides strategic and operational leadership as well as medical<br />
and scientific direction related <strong>to</strong> blood services and products, labora<strong>to</strong>ry testing, donor collection and<br />
counseling, hospital relations, expansion of new business and services, and clinical research.<br />
In addition <strong>to</strong> his position at Bonfils, Dr. Land currently serves as chair of America’s <strong>Blood</strong> <strong>Center</strong>s’<br />
scientific, medical, and technology committee and the AABB’s Donor Biovigilance working group, circular<br />
of information taskforce, and TRALI taskforce. He is also past chair of the <strong>Texas</strong> Medical<br />
Association’s <strong>Blood</strong> and <strong>Tissue</strong> Usage Committee and sits on the Colorado Medical Society’s Patient<br />
Safety and Professional Liability Working Group.<br />
Dr. Land said he is happy <strong>to</strong> return <strong>to</strong> <strong>Texas</strong>: “I am excited <strong>to</strong> be coming <strong>to</strong> San An<strong>to</strong>nio and being involved<br />
with this dynamic organization, city, region and state.” (Sources: STBTC press release, 1/6/10;<br />
www.bonfils.org, accessed 1/6/10) <br />
Qualtex Labora<strong>to</strong>ries Will <strong>Get</strong> a <strong>New</strong> Leader in Norman Kalmin, MD<br />
Norman Kalmin, MD, will become the next president/<strong>CEO</strong> and medical direc<strong>to</strong>r of Qualtex Labora<strong>to</strong>ries<br />
this year. Dr. Kalmin currently holds that position at <strong>South</strong> <strong>Texas</strong> <strong>Blood</strong> & <strong>Tissue</strong> <strong>Center</strong> (STBTC),<br />
where he will be succeeded by Kevin Land, MD (see related s<strong>to</strong>ry, page 1).<br />
Dr. Kalmin, who has served as <strong>CEO</strong> at STBTC for 26 years, will relocate midyear<br />
<strong>to</strong> supervise the further development of Qualtex Labora<strong>to</strong>ries, an affiliate<br />
of STBTC that is expanding its testing services and opening a satellite facility in<br />
Norcross, Ga., a suburb of Atlanta. Qualtex was spun off from STBTC in 2007;<br />
it registered with the Food and Drug Administration and now provides infectious<br />
disease testing services <strong>to</strong> blood banks and plasma centers.<br />
STBTC has grown exponentially under Dr. Kalmin’s leadership. When he<br />
started, it was a small blood center that collected 50,000 pints of blood a year<br />
and had an annual revenue of less than $5 million, according <strong>to</strong> an STBTC press<br />
release. In 2009, it collected more than 200,000 blood components, recovered<br />
over 200 tissue donations, banked 4,000 cord blood units, and tested more than 7 million biological samples.<br />
It is budgeted <strong>to</strong> generate some $148 million in 2010.<br />
“The growth and diversification of services through Norman’s leadership have been keys <strong>to</strong> our success<br />
as one of the most respected community healthcare facilities in the country,” Dr. Anthony Infante, chair<br />
of the STBTC Board of Direc<strong>to</strong>rs, said in the release. “We know he will do a tremendous job building<br />
Qualtex Labora<strong>to</strong>ries in<strong>to</strong> a leading, worldwide resource for blood and plasma testing.”<br />
Dr. Kalmin completed his medical training at the University of Witwatersrand in Johannesburg, Republic<br />
of <strong>South</strong> Africa. He began a clinical pathology residency at the <strong>South</strong> African Institute for Medical Research<br />
in Johannesburg just before he emigrated <strong>to</strong> the US in 1976. He completed his residency at the Erie<br />
County Medical <strong>Center</strong> in Buffalo, N.Y., and received his certifications in pathology and blood banking<br />
from the American Board of Pathology. He joined STBTC as medical direc<strong>to</strong>r in 1983 and was appointed<br />
<strong>CEO</strong> of the organization shortly thereafter. Previously, he was the associate medical direc<strong>to</strong>r for the<br />
American Red Cross <strong>Blood</strong> Services in Atlanta.<br />
(continued on page 8)
ABC <strong>New</strong>sletter -8- January 8, 2010<br />
Kalmin Heads <strong>to</strong> Qualtex (continued from page 7)<br />
Dr. Kalmin has served on and chaired many local, national, and international blood and tissue boards and<br />
committees and is currently the vice president of the International Society of <strong>Blood</strong> Transfusion, headquartered<br />
in Amsterdam, Netherlands.<br />
“I have thoroughly enjoyed the opportunity that the <strong>South</strong> <strong>Texas</strong> community has given me over the years<br />
<strong>to</strong> build STBTC in<strong>to</strong> a world-class facility that has enhanced the lives of thousands of patients in this<br />
region and across the globe,” Dr. Kalmin said. “I look forward <strong>to</strong> developing the services provided by<br />
Qualtex Labora<strong>to</strong>ries and am delighted that my transition <strong>to</strong> an affiliate of STBTC will enable me <strong>to</strong> remain<br />
part of the organization that has been my professional home for more than a quarter century.”<br />
(Source: STBTC press release, 1/6/10) <br />
RESEARCH<br />
Study: Presence of Strep Pneumonia Can Indicate H1N1 Infection Severity<br />
The presence of Strep<strong>to</strong>coccus pneumoniae in individuals between the ages of 6 and 55 with H1N1<br />
influenza was associated with a 125-fold increased risk of severe disease, according <strong>to</strong> a new study<br />
published in the online journal Public Library of Science ONE (PloS One).<br />
The finding means that the presence of S. pneumoniae must be considered a risk fac<strong>to</strong>r for H1N1 –<br />
independent of obesity, asthma, diabetes, or chronic illness. The discovery was made after reports of<br />
higher morbidity and mortality rates in flu victims in Argentina prompted researchers from Argentina’s<br />
National Institute of Infectious Diseases <strong>to</strong> team up with scientists at the <strong>Center</strong> for Infection and<br />
Immunity at the Mailman School of Public Health at Columbia University in <strong>New</strong> York City <strong>to</strong> learn<br />
more.<br />
Last May, the World Health Organization (WHO) estimated an H1N1 case fatality rate (CFR) of 0.6 percent,<br />
similar <strong>to</strong> that of seasonal influenza in Argentina. In July 2009, however, Argentina reported 3,056<br />
cases with 137 deaths, representing a CFR of 4.5 percent. Initially, health officials suspected virus reassortment,<br />
genetic drift, or infection of a more vulnerable population.<br />
The researchers examined nasopharyngeal samples representing 199 H1N1 cases from Argentina – 39<br />
classified as severe and 160 as mild. Virus genomic sequencing of 26 of the samples (representing both<br />
severe and mild disease) indicated no evidence of reassortment, mutations associated with resistance <strong>to</strong><br />
antiviral drugs, or genetic drift. No evidence was found for increased frequency of risk fac<strong>to</strong>rs for H1N1.<br />
Researchers then turned <strong>to</strong> the possibility of bacterial or viral coinfection as a possible<br />
explanation for the unexpected severe illnesses. Using a new technology called MassTag<br />
PCR that can simultaneously detect the presence of several pathogens, the researchers<br />
linked H1N1 severity <strong>to</strong> S. pneumoniae. The association between severe disease and coinfection<br />
with S. pneumoniae was so strong, especially among those not in high-risk groups,<br />
that the researchers did rapid strep tests on flu patients <strong>to</strong> identify the bacteria’s presence<br />
in time <strong>to</strong> ramp up their care.<br />
According <strong>to</strong> Mady Hornig, MD, of Mailman School of Public Health, the study’s co-first author, “This<br />
study is the first <strong>to</strong> demonstrate that the diagnosis of S. pneumoniae, when it is still actionable, might have<br />
an impact on clinical management.”<br />
(continued on page 9)
ABC <strong>New</strong>sletter -9- January 8, 2010<br />
H1N1 and Strep (continued from page 8)<br />
The authors said that at least one additional bacterium or virus was found in 76 percent of the patients.<br />
Haemophilus influenzae; S. pneumoniae, or pneumococcus; and Staphylococcus aureus were the most<br />
common. Other viruses found were respira<strong>to</strong>ry syncytial virus, human rhinovirus, human coronaviruses,<br />
Klebsiella pneumoniae, Acine<strong>to</strong>bacter baumanii, Serratia marcescens, and methicillin-resistant S. aureus,<br />
or MRSA.<br />
Of all the organisms, pneumococcus had by far the strongest association with severe disease and death. It<br />
was found in 56 percent of the 20 patients who died and 19 who were hospitalized, and also in 25 percent<br />
of 160 milder cases, a higher correlation than existed for any of the other coinfecting pathogens.<br />
Pneumococcus was found in approximately half of those who fell ill and were less than 6 years old or<br />
over 55, groups that the Argentinean government considered high risk. But it was present in two-thirds of<br />
those in the low-risk age range (6 <strong>to</strong> 55 years) who fell severely ill, and in one-fourth of that age range<br />
who were mildly ill. In the low-risk age group, the odds ratio for severe illness in the presence of S.<br />
pneumoniae coinfection was 125.5. Because of that correlation, diagnosis of bacterial coinfection can<br />
serve as a signal of flu patients’ increased risk of serious illness, and rapid bacterial detection methods<br />
such as PCR should be considered, the authors said.<br />
The possibility that bacterial coinfections can increase flu’s morbidity and mortality has been a concern<br />
since the beginning of the H1N1 pandemic, driven by findings from earlier pandemics of bacterial pneumonias<br />
among the dead. The <strong>Center</strong>s for Disease Control and Prevention announced in September and<br />
also in November that bacterial infections were playing a role in serious and fatal flu cases, particularly<br />
among young adults, and it urged people <strong>to</strong> consider pneumococcal vaccination. (Sources: CIDRAP,<br />
12/31/09; United Press International, 1/1/10)<br />
Citation: Palacios G, et al. Strep<strong>to</strong>coccus pneumoniae coinfection is correlated with the severity of H1N1<br />
pandemic influenza. PLoS ONE 2009 Dec 31;4(12):e8540. <br />
Studies Investigate the Link between Virus and Chronic Fatigue Syndrome<br />
The recent discovery of a possible link between an infectious retrovirus and chronic fatigue syndrome<br />
(CFS) has raised concerns about blood safety risks. But scientists in the US and the UK have reached very<br />
different conclusions about the presence of the virus in the blood of people with CFS, and investigations<br />
are proceeding in<strong>to</strong> possible implications for the blood supply.<br />
CFS is a syndrome with no known cause. The chief symp<strong>to</strong>m is a persistent, debilitating fatigue that is<br />
not related <strong>to</strong> exertion and is not relieved by rest. It is also associated with muscle and joint pain, cognitive<br />
difficulties, mental and physical exhaustion, and other symp<strong>to</strong>ms, and it can last for years. It is<br />
estimated <strong>to</strong> affect 17 million people worldwide. Because there is no known cause or diagnostic test, most<br />
patients with CFS experience stigma and skepticism about their symp<strong>to</strong>ms.<br />
US Scientists Find a Link <strong>to</strong> the Retrovirus. The possible link between the virus and CFS was asserted<br />
in Oc<strong>to</strong>ber, when a team of researchers published an article online in Science reporting that they had<br />
found that the blood of people with CFS frequently contained a novel gamma retrovirus, xenotropic murine<br />
leukemia virus-related virus (XMRV), which could be detected by nucleic acid amplification tests.<br />
The virus had been previously linked <strong>to</strong> prostate cancer, but not <strong>to</strong> CFS.<br />
(continued on page 10)
ABC <strong>New</strong>sletter -10- January 8, 2010<br />
CFS and XMRV (continued from page 9)<br />
The scientists carried out their research at the Whittemore Peterson Institute (WPI) at the University of<br />
Nevada, Reno; the National Cancer Institute, part of the National Institutes of Health (NIH); and the<br />
Cleveland Clinic.<br />
When the team studied peripheral blood mononuclear cells, they identified XMRV in the<br />
blood of 68 of 101 patients with CFS (67 percent), but only eight of 218 healthy people (3.7<br />
percent). In cell culture experiments, they found the patient-derived XMRV <strong>to</strong> be infectious,<br />
and they found that both cell-associated and cell-free transmission of the virus was<br />
possible. They confirmed their findings when they observed retrovirus particles in patient<br />
samples using transmission electron microscopy.<br />
The recognition of a correlation between XMRV and CFS “could be a major step in the discovery of vital<br />
treatment options for millions of patients,” said Judy Mikovits, PhD, direc<strong>to</strong>r of WPI and leader of the<br />
research team. However, she and her colleagues also emphasized that while their findings indicate an<br />
association between XMRV and CFS, they do not prove that XMRV causes CFS.<br />
No Link Found in the UK. However, another team of scientists, this one based in London, screened<br />
blood samples from 186 patients with CFS for XMRV and the closely related murine leukemia virus<br />
(MLV). They found no evidence for the presence of either virus in any of their samples.<br />
This team was led by Myra McClure, PhD, a professor at Imperial College London, and their study was<br />
published online in PLoS One Wednesday. They used a standard procedure <strong>to</strong> prepare specimens for<br />
nucleic acid amplification testing. Their patients all had been referred <strong>to</strong> the CFS clinic at King’s College<br />
Hospital in London and were “markedly unwell.” Based on their demographics, the researchers determined<br />
them <strong>to</strong> be “typical of CFS patients seen in specialist clinical services in the UK.”<br />
Given that they did not find XMRV or MLV in the blood of these patients, the researchers<br />
wrote that they “do not share the conviction that XMRV may be a contribu<strong>to</strong>ry fac<strong>to</strong>r<br />
in the pathogenesis of CFS, at least in the UK.”<br />
Speculation about reasons why the two teams of scientists came up with conflicting results started immediately.<br />
An article in ScienceNOW Daily <strong>New</strong>s, which also was published on Wednesday, summarized<br />
theories offered by a number of retrovirus experts: the two teams of scientists may have looked for different<br />
DNA sequences; the American samples may have been contaminated; there may be different varieties<br />
of XMRV in different parts of the world; or CFS may have multiple causes.<br />
Potential Implications for the <strong>Blood</strong> Supply. In any case, the possible relationship between XMRV and<br />
CFS raises questions about whether XMRV might be present in blood donated by people with CFS,<br />
whether it could then be passed <strong>to</strong> recipients of transfusions, and whether it might then cause CFS in<br />
those recipients.<br />
Michael Busch, MD, PhD, direc<strong>to</strong>r of <strong>Blood</strong> Systems Research Institute (BSRI), <strong>to</strong>ld a writer in November<br />
that while viruses that could be transferred through blood are identified every year or so, “most of the<br />
time these things don’t evolve <strong>to</strong> be a serious problem.” As a precaution, he indicated that people with<br />
diagnosed CFS “should probably refrain from donating until specific studies are conducted <strong>to</strong> establish<br />
whether XMRV is causally linked <strong>to</strong> CFS and the virus is present in healthy donors and transmitted by<br />
transfusions.” He said that such studies should evolve in the next three <strong>to</strong> 12 months.<br />
(continued on page 11)
ABC <strong>New</strong>sletter -11- January 8, 2010<br />
CFS and XMRV (continued from page 10)<br />
Indeed, AABB has constituted a task force that includes major blood banking organizations and representatives<br />
from NIH, <strong>Center</strong>s for Disease Control, the Food and Drug Administration, the Department of<br />
Health and Human Services (HHS), and WPI <strong>to</strong> assess the potential impact of XMRV on the blood<br />
supply. Dr. Louis Katz, from Mississippi Valley Regional <strong>Blood</strong> Services, is the America’s <strong>Blood</strong> <strong>Center</strong>s<br />
representative <strong>to</strong> the task force. Dr. Simone Glynn, Branch Chief of Transfusion Medicine and Cellular<br />
Therapeutics at National Heart, Lung, and <strong>Blood</strong> Institute is coordinating a national study that will screen<br />
blood samples from healthy donors at multiple labora<strong>to</strong>ries. The goal is <strong>to</strong> evaluate the different assays<br />
available for detection of XMRV and <strong>to</strong> determine the prevalence of the virus in the blood supply. BSRI’s<br />
Dr. Busch is one of the investiga<strong>to</strong>rs in the project.<br />
The link between XMRV and CFS also received attention at a meeting of HHS’s Chronic Fatigue Syndrome<br />
Advisory Committee on Oct. 29 and 30. Daniel Peterson, MD, of WPI and John Coffin, PhD, of<br />
Tufts University gave presentations related <strong>to</strong> the possible link, and written and public testimony was<br />
heard. (Sources: Las Vegas CityLife, 11/15/09; www.hhs.gov/advcomcfs, accessed 1/6/10;<br />
www.cancer.gov, accessed 1/6/10; ScienceNOW Daily <strong>New</strong>s, 1/6/10)<br />
Citations: Lombardi VC, et al. Detection of an infectious retrovirus, XMRV, in blood cells of patients<br />
with Chronic Fatigue Syndrome. Science 2009 Oct 23;326(5952):585-9. Epub 2009 Oct 8. Erlwein O, et<br />
al. Failure <strong>to</strong> detect the novel retrovirus XMRV in Chronic Fatigue Syndrome. PLoS One 2010 Jan;5(1).<br />
Epub 2010 Jan 6. <br />
<strong>New</strong> Guidelines Address Red <strong>Blood</strong> Cell Transfusions<br />
Although various professional groups have issued guidelines on the transfusion of red blood cells<br />
(RBCs), none has specifically addressed transfusions in critically ill and injured adult patients. But a new<br />
set of guidelines, published in the December issue of Critical Care Medicine, attempts <strong>to</strong> fill this gap.<br />
The guidelines offer key recommendations for RBC transfusion in generally critically ill patients, those<br />
with sepsis, those with or at risk for acute lung injury and acute respira<strong>to</strong>ry distress syndrome, and those<br />
with neurologic injury and diseases. In addition, the guidelines discuss RBC transfusion risks, alternatives<br />
<strong>to</strong> RBC transfusion, and strategies <strong>to</strong> reduce RBC transfusion.<br />
Lena M. Napolitano, MD, and colleagues from the American College of Critical Care Medicine (ACCM)<br />
of the Society of Critical Care Medicine (SCCM) and the Eastern Association for the Surgery of Trauma<br />
(EAST) Practice Management Workgroup, developed the guidelines. The team used information from<br />
meetings, teleconferences, and other electronic communications in grading the published data on transfusion<br />
practice and outcomes.<br />
“<strong>Blood</strong> transfusion is clearly indicated for the treatment of hemorrhagic shock, particularly in patients<br />
who have reached critical oxygen delivery,” said Dr. Napolitano. “Independent of the mechanism of injury,<br />
hemorrhagic shock consistently represents the second leading cause of early deaths among the<br />
injured, with only central nervous system injury consistently more lethal.”<br />
For critically ill patients with hemodynamically stable anemia, except possibly for those with acute myocardial<br />
ischemia, a “restrictive” strategy of RBC transfusion (hemoglobin [Hb] level < 7 g/dL) is equally<br />
as effective as a “liberal” transfusion strategy (Hb level < 10 g/dL; level I). Use of only Hb level as a<br />
(continued on page 12)
ABC <strong>New</strong>sletter -12- January 8, 2010<br />
Red <strong>Blood</strong> Cell Transfusions (continued from page 11)<br />
“trigger” for transfusion should be avoided, the authors contend. They assert that the decision <strong>to</strong> transfuse<br />
should be based on intravascular volume status, evidence of shock, duration and extent of anemia, and<br />
cardiopulmonary physiologic parameters. RBC transfusion should be given as single units except for<br />
patients with acute hemorrhage.<br />
In an accompanying edi<strong>to</strong>rial, Constantino José Fernandes Jr, MD, from Hospital Israelita Albert Einstein<br />
in São Paulo, Brazil, said the guidelines have merit but notes that red blood cell deformability is critical<br />
for oxygen usefulness in sepsis. “RBC transfusion is usually employed <strong>to</strong> increase oxygen transport in<br />
sepsis in the hope that adequate oxygen supply will assure optimal oxygen use and thereby minimize<br />
organ dysfunction,” Dr. Fernandes writes. “This assumption … does not take in<strong>to</strong> consideration the frequent<br />
alterations in blood cell rheology in critically ill septic patients. These alterations can be influenced<br />
by many fac<strong>to</strong>rs, including alterations in intracellular calcium and adenosine triphosphate concentrations,<br />
a decrease in some RBC membrane components such as sialic acid, and changes in 2,3-<br />
diphosphoglycerate.” (Source: Medscape Medical <strong>New</strong>s, 12/30/09)<br />
Citations: Napolitano, LM et al. Clinical practice guideline: Red blood cell transfusion in adult trauma<br />
and critical care. Critical Care Medicine. 2009. 37(12):3124-3157; Napolitano LM, et al. Clinical practice<br />
guideline: red blood cell transfusion in adult trauma and critical care. J Trauma 2009 Dec;67(6):1439-<br />
42; Sihler KC and Napolitano LM. Complications of massive transfusion. Chest 2010 Jan;137(1):209-20.<br />
<br />
BRIEFLY NOTED<br />
Some $60 million in funding is available <strong>to</strong> support four research projects designed <strong>to</strong> find solutions<br />
<strong>to</strong> health information technology (IT) adoption challenges. Research supported by the Strategic Health<br />
IT Advanced Research Projects (SHARP) program will focus on areas where “breakthrough” advances<br />
are needed. The projects will be specifically designed and dedicated <strong>to</strong> overcoming health IT challenges<br />
<strong>to</strong> adoption and meaningful use and supporting the goals of the HITECH Act. The awards will range from<br />
$10 million <strong>to</strong> $18 million and applications must be received by COB Jan. 25. (Edi<strong>to</strong>r’s note The ABC<br />
<strong>New</strong>sletter contacted Wil Yu, a special assistant in the Office of the National Coordina<strong>to</strong>r for Health Information<br />
Technology, who said that the funding is open <strong>to</strong> educational institutions as well as nonprofit<br />
organizations “with a research mission.” Though the HITECH Act lists blood centers as healthcare providers,<br />
HIT funding through that office has so far been restricted <strong>to</strong> traditional healthcare settings.) The<br />
Office of the National Coordina<strong>to</strong>r on Monday hosted a second Technical Assistance call for potential<br />
SHARP program applicants, A transcript of the call and the slide deck was supposed <strong>to</strong> be posted on<br />
http://healthit.hhs.gov in coming days. A previous technical assistance call was held on Dec. 22. Transcript<br />
and the PowerPoint slide presentation from the call are available at http://healthit.hhs.gov/sharp.<br />
For more information on the SHARP program, visit http://healthit.hhs.gov/sharp. Visit<br />
http://healthit.hhs.gov/hitechgrants for information on additional HITECH funding opportunity announcements.<br />
The Food and Drug Administration approved Fluzone High-Dose, a vaccine for people 65 and older<br />
<strong>to</strong> prevent disease caused by influenza virus subtypes A and B. People in this age group are at highest<br />
risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination<br />
remains the best protection from influenza, particularly for people 65 and older. Fluzone High-Dose<br />
was approved via the accelerated approval pathway. FDA’s accelerated approval pathway<br />
(continued on page 13)
ABC <strong>New</strong>sletter -13- January 8, 2010<br />
BRIEFLY NOTED (continued from page 12)<br />
helps safe and effective medical products for serious or life-threatening diseases become available sooner.<br />
In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone<br />
in individuals 65 and older. As part of the accelerated approval process, the manufacturer is required<br />
<strong>to</strong> conduct further studies <strong>to</strong> verify that the Fluzone High-Dose will decrease seasonal influenza disease<br />
after vaccination. “As people grow older, their immune systems typically become weaker,” said Karen<br />
Midthun, MD, acting direc<strong>to</strong>r of the FDA’s <strong>Center</strong> for Biologics Evaluation and Research. “This is the<br />
first influenza vaccine that uses a higher dose <strong>to</strong> induce a stronger immune response that is intended <strong>to</strong><br />
better protect the elderly against seasonal influenza.” Fluzone High-Dose, manufactured by Sanofi Pasteur<br />
Inc., is formulated so that each 0.5 mL dose contains a <strong>to</strong>tal of 180 micrograms (mcg) of influenza<br />
virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains. Other<br />
currently licensed seasonal influenza vaccines for adults are formulated <strong>to</strong> contain a <strong>to</strong>tal of 45 mcg of<br />
influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur,<br />
also manufactures Fluzone, a seasonal vaccine approved for use in individuals 6 months and older.<br />
As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination<br />
with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during<br />
clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever<br />
and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.<br />
People with hypersensitivity <strong>to</strong> egg proteins or life-threatening reactions after previous<br />
administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose. Fluzone High-<br />
Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes<br />
without preservative. (Sources: Sanofi Pasteur press release, 12/24/09; FDA Web site)<br />
The deadline for completing the 2009 National <strong>Blood</strong> Collection and Utilization Survey (NBCUS)<br />
has been extended until Jan. 29. The 2009 survey was sent <strong>to</strong> all blood centers and approximately 3,000<br />
hospitals that transfuse blood in the US. A separate questionnaire was sent <strong>to</strong> nearly 250 sites involved in<br />
cellular therapies. The NBCUS solicits general information about blood collection facilities, transfusion<br />
services, and cord blood banks, as well as specific data about blood collection, transfusion, cellular therapies,<br />
and product modification, including leukoreduction and irradiation. The data is used <strong>to</strong> support<br />
blood-related initiatives by the federal government and the transfusion medicine community. This biennial<br />
survey is funded by the U.S. Department of Health and Human Services and conducted by AABB.<br />
Barbee I. Whitaker, PhD, direc<strong>to</strong>r of data and special programs at AABB, emphasized the importance of<br />
the survey: “The more complete the data – in other words, the more hospitals and blood centers that participate<br />
– the more accurate the survey results will be as a <strong>to</strong>ol for policymaking and <strong>to</strong> assess what is<br />
happening within our community.” Participants may return the survey by mail or submit it online at<br />
www.bloodsurvey.org. Links <strong>to</strong> the full survey and <strong>to</strong> frequently asked questions about it are available at<br />
www.aabb.org/nbcus.<br />
Theodore Collins, PhD, is a veteran cancer researcher with connections <strong>to</strong> the best doc<strong>to</strong>rs anywhere,<br />
but none of it could save his 26-year-old daughter Natasha from succumbing <strong>to</strong> leukemia.<br />
Dr. Collins is hoping <strong>to</strong> save others through “Natasha’s Place,” an umbilical cord blood bank. Natasha’s<br />
Place bills itself as the first cord blood bank in the nation with an emphasis on mixed heritage and minorities.<br />
The organization will reach out <strong>to</strong> African Americans, Asians, Latinos and other minorities.<br />
Natasha’s Place, based in <strong>New</strong> Haven, Conn., uses ethno-demographics and DNA identification <strong>to</strong> establish<br />
matches. All the public cord blood information will go in<strong>to</strong> a global registry. Although Natasha’s<br />
Place serves people of every ethnicity, its research and advocacy components focus on mixed heritage and<br />
minority-related issues. Natasha, a medical student at Yale University when she died in August, was of<br />
mixed race, and that put her on the most unlevel of playing fields in the search for a bone marrow match.<br />
“It’s impossible for mixed race and most minorities <strong>to</strong> get a perfect match,” said Mr. Collins, a<br />
(continued on page 14)
ABC <strong>New</strong>sletter -14- January 8, 2010<br />
STOPLIGHT: Status of the ABC <strong>Blood</strong> Supply, 2009 vs. 2010<br />
3%<br />
11%<br />
3%<br />
17%<br />
2%<br />
7%<br />
2%<br />
13%<br />
2%<br />
14%<br />
1%<br />
15%<br />
2%<br />
28%<br />
4%<br />
3%<br />
10%<br />
18%<br />
11%<br />
13%<br />
80%<br />
76%<br />
83%<br />
76%<br />
62%<br />
63%<br />
59%<br />
75%<br />
59%<br />
68%<br />
7%<br />
4%<br />
8%<br />
10%<br />
26%<br />
20%<br />
11%<br />
17%<br />
12%<br />
9%<br />
12/10/08 12/9/09 12/17/08 12/16/09 12/24/08 12/23/09 12/31/08 12/30/09 1/7/09 1/6/10<br />
No Response Green: 3 or More Days Yellow: 2 Days Red: 1 Day or L<br />
The or der of the bar s i s (f r om <strong>to</strong>p <strong>to</strong> bot<strong>to</strong>m), r ed, yel l ow, gr een, and no r esponse<br />
BRIEFLY NOTED (continued from page 13)<br />
clinical immunologist. “It’s the chance of finding a small needle in a big haystack.” Two of the main reasons<br />
matches are so difficult are because minority populations are heterogeneous, meaning there’s a lot of<br />
ethnic mixing, and because there are fewer minorities and mixed-race people overall. To compound the<br />
problem, cultural fac<strong>to</strong>rs and lack of awareness has meant fewer minorities being willing <strong>to</strong> be tested as<br />
possible matches, he said. Dr. Collins said only 7 percent of all African Americans have donors, which<br />
means, “We lose 93 percent.” He also is advocating on behalf of individuals in need of a match with an<br />
organization, “Become My Hero,” which publicizes the quest of specific patients in need of stem cells <strong>to</strong><br />
save their lives. They are the largest cord blood donor recruiter network in the world. “I’m trying <strong>to</strong> make<br />
some good out of it,” Dr. Collins said, referring <strong>to</strong> his daughter’s death. Natasha’s Place is operated in<br />
partnership with Cryobanks International, a private and public s<strong>to</strong>rage facility. The advantage of stem<br />
cell-rich cord blood in treating patients with leukemia, sickle cell anemia, lupus, heart disease, liver disease,<br />
immune disorders, diabetes and many and other life-threatening illness is that the match doesn’t<br />
have <strong>to</strong> be as exact as with bone marrow, and won’t cause life-threatening complications. Natasha didn’t<br />
die from leukemia, but rather a graft vs. host rejection, because the bone marrow match was far from perfect,<br />
Dr. Collins said. More information about Natasha’s Place is available at www.natashasplace.org.<br />
(Source: <strong>New</strong> Haven Register, 1/3/09) <br />
GLOBAL NEWS<br />
In Wales, people will now have <strong>to</strong> “opt out” of organ donations, rather than opting in. The change<br />
means that people are presumed <strong>to</strong> want <strong>to</strong> be organ donors; they have <strong>to</strong> sign up if they do not want <strong>to</strong> be<br />
organ donors. (In an opt-in system, people have <strong>to</strong> sign up <strong>to</strong> be organ donors; otherwise, it is assumed<br />
that they do not want <strong>to</strong> donate their organs.) The change, which was made on Dec. 22 by the Welsh assembly’s<br />
health minister, Edwina Hart, excludes people who cannot be identified, can be proven <strong>to</strong> have<br />
changed their wishes, or have immediate family members who object. A number of European countries<br />
have opt-out systems, which often raise the rate of organ donation. Wales is the first country in the UK <strong>to</strong><br />
move <strong>to</strong> an opt-out system. The change was prompted by the shortage of organs for transplantation in that<br />
country; the Welsh people were found <strong>to</strong> support the change by a margin <strong>to</strong> two <strong>to</strong> one. (Source: guardian.co.uk,<br />
12/22/09)
ABC <strong>New</strong>sletter -15- January 8, 2010<br />
INSIDE ABC<br />
Thank a Donor Web Site Connects <strong>Blood</strong> Donors and Recipients<br />
America’s <strong>Blood</strong> <strong>Center</strong>s (ABC) on Tuesday launched a new Web site that offers blood transfusion recipients<br />
the chance <strong>to</strong> connect with blood donors. The new Web site, which is called “Thank a Donor” and is available<br />
at www.thanksdonor.com, aims <strong>to</strong> forge meaningful connections between people who donate blood and the<br />
people who receive it.<br />
“Our blood centers rely on the generosity of people who, in most cases, never meet the beneficiaries of their<br />
kindness,” said ABC President Thomas Schallert. “This site gives those who have received a blood transfusion,<br />
as well as their families and friends, the chance <strong>to</strong> tell their s<strong>to</strong>ries and personally say thank you. We<br />
hope the running dialogue on this site will inspire others <strong>to</strong> give blood, make a charitable contribution <strong>to</strong> a<br />
blood center, or volunteer their time.”<br />
The site allows visi<strong>to</strong>rs <strong>to</strong> upload images, videos, and descriptions of their connection <strong>to</strong> blood donation. Visi<strong>to</strong>rs<br />
<strong>to</strong> the social networking site can browse profiles or participate in conversations; they also can create<br />
personal profiles and interact with others via the site’s comment feature. Using the site’s search function, visi<strong>to</strong>rs<br />
also can browse other people’s profiles and use keywords <strong>to</strong> find donors or recipients with mutual<br />
interests or backgrounds.<br />
HHS Official Recognizes National <strong>Blood</strong> Donor Month, Encourages Donations<br />
The Department of Health and Human Services (HHS) has issued a statement in honor of National <strong>Blood</strong> Donor<br />
Month, calling for “everyday heroes whose gift of blood donation can allow others <strong>to</strong> raise their quality of<br />
life.” America’s <strong>Blood</strong> <strong>Center</strong>s’ (ABC) marketing and communications staff worked with HHS <strong>to</strong> craft the<br />
statement, issued by Assistant Secretary for Health, Howard K. Koh, MD, MPH.<br />
Dr. Koh uses the statement <strong>to</strong> encourage more people <strong>to</strong> donate blood. He points out, for example, that someone<br />
in the US needs a blood transfusion every two seconds and that “more than 40,000 units of blood are<br />
needed every day in this country.” He also explains that less than 5 percent of people who would be eligible <strong>to</strong><br />
donate do so. He closes by encouraging people <strong>to</strong> locate their nearest blood center by visiting ABC’s Web site<br />
or by calling 1-888-USBLOOD.<br />
The statement is being distributed <strong>to</strong> media outlets around the country. The statement is available at<br />
http://www.hhs.gov/ophs/news/20100107.html.<br />
ASK ABC<br />
Edi<strong>to</strong>r’s Note: The ABC <strong>New</strong>sletter periodically answers questions posed by members of America’s <strong>Blood</strong><br />
<strong>Center</strong>s in a recent survey.<br />
Q: What is the best way I can benefit from ABC<br />
A: The best way <strong>to</strong> benefit from ABC’s services and resources is <strong>to</strong> take part in ABC’s Listservs, conference<br />
calls, Data Warehouse, Webinars, workshops, and meetings. To provide input and set the direction of<br />
ABC’s policies and initiatives, volunteer on the appropriate ABC Committee. A quick and simple guide<br />
<strong>to</strong> America’s <strong>Blood</strong> <strong>Center</strong>s and the services provided <strong>to</strong> members can be found at<br />
http://members.americasblood.org/go.cfmdo=File<strong>Center</strong>.View&fid=2102.
ABC <strong>New</strong>sletter -16- January 8, 2010<br />
INFECTIOUS DISEASE UPDATES<br />
In China, some patients with severe H1N1 are being treated with plasma from people who have<br />
recently recovered from or been vaccinated for the virus. The logic behind the experimental treatment<br />
is that these plasma donors have high levels of H1N1 antibodies in their blood and that transferring those<br />
antibodies through plasma transfusions could help severely or critically ill patients recover faster. Because<br />
the approach is still being evaluated, it has not yet been recommended by the World Health Organization.<br />
But a similar strategy was used in 2002-2003 during the outbreaks of avian flu and severe acute respira<strong>to</strong>ry<br />
syndrome. Some experts have heralded the strategy as an alternative treatment for patients, particularly<br />
if the H1N1 virus has penetrated deeply in<strong>to</strong> their lungs and thus is difficult <strong>to</strong> treat with Tamiflu. But<br />
others are urging caution until more testing can be done and pro<strong>to</strong>cols can be set. (Source: The Canadian<br />
Press, 12/25/09) <br />
LEGISLATIVE NEWS<br />
According <strong>to</strong> senior Capi<strong>to</strong>l Hill staffers, one from each chamber, House and Senate Democrats are<br />
“almost certain” <strong>to</strong> negotiate informally, rather than convene a conference committee <strong>to</strong> merge the<br />
two chambers’ versions of the healthcare reform bill. Doing so would allow Democrats <strong>to</strong> avoid a<br />
series of procedural steps – not least among them, a series of special motions in the Senate, each requiring<br />
a vote with full debate – that Republicans could use <strong>to</strong> stall deliberations, just as they did in November<br />
and December. “There will almost certainly be full negotiations but no formal conference,” a House<br />
staffer <strong>to</strong>ld a writer from the <strong>New</strong> Republic magazine (1/3/10). “There are <strong>to</strong>o many procedural hurdles <strong>to</strong><br />
go the formal conference route in the Senate.” One reason Democrats expect Republicans <strong>to</strong> keep trying<br />
procedural delays is that the Republicans have signaled their intent <strong>to</strong> do so. On Christmas Eve, when the<br />
Senate passed its bill, Minority Leader Mitch McConnell (R-Ky.) vowed in a floor speech, “This fight<br />
isn’t over. My colleagues and I will work <strong>to</strong> s<strong>to</strong>p this bill from becoming law.” Said the Senate staffer, “I<br />
think the Republicans have made our decision for us. . . . It’s time for a little ping-pong.” “Ping pong” is a<br />
reference <strong>to</strong> one way the House and Senate could proceed. With ping-ponging, the chambers send<br />
legislation back and forth <strong>to</strong> one another until they finally have an agreed-upon version of the bill. But<br />
even ping-ponging can take different forms and some people use the term generically <strong>to</strong> refer <strong>to</strong> any<br />
informal negotiations. Whatever form the final discussions take, a decision <strong>to</strong> bypass conference would<br />
undoubtedly expedite the debate, clearing the way for final passage (if not signing) by the end of January.<br />
Republicans are sure <strong>to</strong> complain that they’re being excluded from deliberations.<br />
The American Red Cross will receive $400,000 in federal funding for a program <strong>to</strong> test blood for<br />
the dengue virus in Puer<strong>to</strong> Rico as a result of language inserted in<strong>to</strong> the federal appropriations bill<br />
signed in<strong>to</strong> law by President Barack Obama. Congressman Pedro Pierluisi (D-PR) secured the funding<br />
last year. In November, a medical officer with the <strong>Center</strong>s for Disease Control and Prevention in San<br />
Juan, Puer<strong>to</strong> Rico, <strong>to</strong>ld the <strong>Blood</strong> Products Advisory Committee that “the US blood supply is at risk” of<br />
the spread of dengue from imported blood and travelers who bring the disease from other countries (see<br />
ABC <strong>New</strong>sletter, 11/20/09). The mosqui<strong>to</strong>es that carry dengue, Aedes aegypti and Aedes albopictus, are<br />
present in the <strong>South</strong>ern and <strong>South</strong>eastern parts of the US. The virus is usually transmitted from person <strong>to</strong><br />
person by mosqui<strong>to</strong> bites, but it can also be transmitted through blood transfusions, transplants, and needlesticks.<br />
Kay Tomashek, MD, said that in 2007, 25 units of blood donated <strong>to</strong> Red Cross in Puer<strong>to</strong> Rico<br />
tested positive for dengue. Twelve of those units had been shipped <strong>to</strong> the US. One recipient in Puer<strong>to</strong><br />
Rico developed dengue hemorrhagic fever. Dr. Tomashek said that ARC centers in Puer<strong>to</strong> Rico – which<br />
collect 40 percent of the blood there – no longer export blood <strong>to</strong> the continental US during epidemic<br />
(continued on page 17)
ABC <strong>New</strong>sletter -17- January 8, 2010<br />
LEGISLATIVE NEWS (continued from page 16)<br />
periods. <strong>Blood</strong> donation screening for dengue virus by direct nucleic acid testing will be implemented by<br />
the Red Cross. <strong>Blood</strong> components from donors that test positive will not be distributed, but will be<br />
destroyed or used for further research. <strong>Blood</strong> donors will be notified of positive results and deferred<br />
temporarily until it is safe <strong>to</strong> collect blood from them again. They will also be given the chance <strong>to</strong> enroll<br />
in<strong>to</strong> research studies <strong>to</strong> define the characteristics of naturally acquired dengue infection <strong>to</strong> further promote<br />
blood safety. (American Red Cross Web site, 12/17/09)<br />
A legislative bill in Ohio that would require physicians and the state health department <strong>to</strong> inform<br />
expectant mothers about umbilical-cord stem cell banking is in a legislative gridlock. The Informed<br />
Choice bill (HB 102), which has passed the Ohio State House and the Senate Health Committee, now<br />
awaits a floor vote in the Senate. Ohio could be on the verge of being the 18th state <strong>to</strong> pass legislation<br />
requiring physicians <strong>to</strong> give expectant mothers information on banking cord blood. “We want parents <strong>to</strong><br />
know about banks out there, that they’re a very valuable <strong>to</strong>ol when it comes <strong>to</strong> health care,” said Rep.<br />
Todd Book (D), who introduced the bill. However, the current political climate in Columbus is such that<br />
neither side is looking <strong>to</strong> pass bills introduced by the other side, resulting in a legislative gridlock in the<br />
Republican-controlled Senate. Rep. Book has expressed frustration at the partisan stalemate, but he says<br />
he is still confident that the bill will be passed before it expires at the end of 2010, which also will signal<br />
the end of his last allowable term in office. “It doesn’t cost much, if anything,” he said. “It can provide a<br />
lot of valuable information [through educational materials such as DVDs and brochures] and maybe save<br />
money in the future.” The Cleveland Cord <strong>Blood</strong> <strong>Center</strong>, one of 22 public cord-blood banks in the country’s<br />
National Marrow Donor Program network, stands ready <strong>to</strong> work with the state on informing the<br />
public. Patients at University Hospitals MacDonald Women’s Hospital and two other Ohio hospitals are<br />
able <strong>to</strong> donate cord blood at three other public blood-bank programs in the country. Public banks do not<br />
charge a s<strong>to</strong>rage fee. They are listed on a US and international registry for use around the world. Private,<br />
or “family,” cord-blood banks charge upward of $2,000, plus an annual s<strong>to</strong>rage fee, and are for the exclusive<br />
use of the donor’s family. (Source: The [Cleveland] Plain Dealer, 12/29/09) <br />
REGULATORY NEWS<br />
The Food and Drug Administration has released a guidance titled “An Acceptable Circular of Information<br />
for the Use of Human <strong>Blood</strong> and <strong>Blood</strong> Components,” effective immediately. This<br />
guidance was issued <strong>to</strong> make a technical correction <strong>to</strong> the “Circular of Information for the Use of Human<br />
<strong>Blood</strong> and <strong>Blood</strong> Components” dated August 2009 with respect <strong>to</strong> the dosage and administration of platelet<br />
components. The reported units for the corrected count increment have been changed <strong>to</strong> “per μL per<br />
10 11 per m 2 .” The changes are on pages 40-41 of the circular and the printed brochure. The corrected circular,<br />
dated December 2009, is available at<br />
www.fda.gov/downloads/Biologics<strong>Blood</strong>Vaccines/GuidanceComplianceRegula<strong>to</strong>ryInformation/Guidance<br />
s/<strong>Blood</strong>/UCM187348.pdf.<br />
The International Society for <strong>Blood</strong> Transfusion (ISBT) has revised its “Guidelines for Validation<br />
of Au<strong>to</strong>mated Systems in <strong>Blood</strong> Establishments.” The new version will be published as a supplement<br />
<strong>to</strong> the February issue of Vox Sanguinis. It reflects changes in regulations and developments in methodologies<br />
since 2003, when the first version was published under a slightly different name. For example, it<br />
reflects the recent developments of ICH Q8, ICH Q9, ICH Q10, GAMP 5, and PIC/S. It also includes a<br />
clearer definition of validation and its relationships <strong>to</strong> a blood establishment’s quality management system;<br />
a discussion of the relationship between risk assessment and validation; and sections on validating<br />
data migration software and network infrastructure, performing supplementary qualifications, using validation<br />
platforms, and validating software patches. The guidelines also include an appendix listing<br />
(continued on page 18)
ABC <strong>New</strong>sletter -18- January 8, 2010<br />
REGULATORY NEWS (continued from page 17)<br />
equipment commonly used by blood establishments and recommended approaches <strong>to</strong> validating each<br />
type. Each blood establishment is responsible for the regula<strong>to</strong>ry compliance of the au<strong>to</strong>mated systems it<br />
uses – i.e., those that have some degree of computerized control. The validation process creates evidence<br />
that all parts related <strong>to</strong> those systems will work correctly and consistently. ISBT’s guidelines are meant <strong>to</strong><br />
promote “a standardized approach <strong>to</strong> the complexities of validation projects for critical computer systems<br />
and equipment in blood establishments,” according <strong>to</strong> the document’s introduction. However, they do not<br />
recommend a particular method for validation; nor do they present a new concept of validation. Instead,<br />
they are meant <strong>to</strong> be “relevant and applicable <strong>to</strong> all blood establishments,” no matter how they approach<br />
validation. Citation: Sampson J, et al. ISBT guidelines for validation of au<strong>to</strong>mated systems in blood establishments.<br />
Vox Sang. 2010 Feb;98 Suppl 1:S1-19. <br />
MEMBER NEWS<br />
Last month, Mississippi <strong>Blood</strong> Services (MBS) broke<br />
ground on a new, state-of-the-art building in Flowood,<br />
Miss. The 52,000-square-foot facility is scheduled <strong>to</strong> be<br />
completed in December 2010. It will more than double the<br />
square footage of the center’s current facility, which David<br />
Allen, MBS’s president and <strong>CEO</strong>, said the center has outgrown. He added that the new building will help<br />
MBS continue <strong>to</strong> “meet the needs of hospital patients across the state with the best services possible.” The<br />
building will allow the center <strong>to</strong> increase its number of beds, and Tony Bahou, the center’s manager of<br />
communications and public relations, said MBS will also update its equipment and therefore be able <strong>to</strong><br />
“fill hospitals’ orders in a more timely fashion.” (Sources: www.msblood.com, accessed 1/8/10; The<br />
[Mississippi] Clarion Ledger, 12/15/09) <br />
PEOPLE<br />
Larry Dumont, MBA, PhD, has been elected chair of the Biomedical Excellence<br />
for Safer Transfusion (BEST) Collaborative. Dr. Dumont will begin his four-year<br />
term in Oc<strong>to</strong>ber 2010. He received his BS from Regis College in Denver and his<br />
MBA from the University of Phoenix. He earned his PhD at the University of<br />
Colorado Health Sciences <strong>Center</strong> in Denver, where he received training in biostatistics<br />
and epidemiology. He spent four years as a clinician in pediatric dialysis at<br />
the University of Colorado and was with COBE Labora<strong>to</strong>ries / Gambro BCT for<br />
27 years as an engineer and manager in Quality Assurance and scientist in research<br />
and development. He has been involved with BEST since 1992 and has<br />
served in leadership roles for the past four years. He is an assistant professor of<br />
pathology at Dartmouth Medical School and directs its Cell Labeling Labora<strong>to</strong>ry. He will replace Lorna<br />
Williamson, MD, the current chair of the BEST Collaborative, who said in a statement, “I am delighted<br />
that Larry will be my successor. . . . He has been a leading member of BEST for some years and has made<br />
major contributions <strong>to</strong> BEST studies. His experience of both manufacturing and academia will bring great<br />
strengths <strong>to</strong> BEST’s endeavors <strong>to</strong> undertake the kind of studies that bridge these two spheres.” The BEST<br />
Collaborative is an international research organization that explores ways <strong>to</strong> improve transfusion-related<br />
services through standardization of analytic techniques, development of new procedures, and clinical<br />
trials in hemotherapy. (Source: BEST Collaborative press release, 12/22/09)<br />
(continued on page 19)
ABC <strong>New</strong>sletter -19- January 8, 2010<br />
PEOPLE (continued from page 18)<br />
Karen Calder has joined the Community <strong>Blood</strong> <strong>Center</strong> of the Carolinas (CBCC) as its direc<strong>to</strong>r of development<br />
and public relations. Calder will work on enhancing the center’s strategic partnerships and blood<br />
donor programs, as well as adding <strong>to</strong> its blood drive sponsors. She has spent the last seven years as executive<br />
direc<strong>to</strong>r of Classroom Central, a non-profit start-up agency that currently distributes $4.5 million in<br />
free school supplies annually. Before that, she worked at the Charlotte Chamber of Commerce and at<br />
InterArt Distribution, a division of Hallmark. Calder earned her BA from the University of North Carolina<br />
at Charlotte. (Source: CBCC press release, 12/21/09) <br />
IN MEMORIAM<br />
A Gainesville, Fla., girl who had participated in an America’s <strong>Blood</strong> <strong>Center</strong>s program, Pints for Half<br />
Pints, has died at the age of 17. Pints for Half-Pints was a three-year national initiative in the late 1990s <strong>to</strong><br />
bring <strong>to</strong>gether child recipients from all the community blood centers and <strong>to</strong> highlight how the generosity<br />
of volunteer blood donors helps save lives. Eliza Lena Huff received blood and became a donation advocate,<br />
coordinating with ABC and the <strong>South</strong>eastern Community <strong>Blood</strong> <strong>Center</strong>. She died Dec. 26 awaiting a<br />
heart/lung transplant at Shands Hospital in Gainesville. She had been there for over seven months. Eliza<br />
was born with congenital heart and lung defects. While awaiting organs, her heart arrested 15 times, but<br />
she battled back. As Katie Kilroy, one of her nurses, put it, “Eliza rewrote the rule book when it comes <strong>to</strong><br />
medical science, determination, and life in general and she will not soon be forgotten by anyone at<br />
Shands.” Eliza became the darling of Tallahassee as an infant when her mother introduced her on her<br />
morning radio show. She was a sophomore and a 4.0 student in the gifted program of Florida Virtual<br />
School and was also a news junkie who was visited by Anderson Cooper one Friday night in a Jacksonville<br />
hospital room. The two hit it off immediately and he surprised her with a copy of The <strong>New</strong> York<br />
Times the following Sunday. In lieu of flowers, contributions can be made <strong>to</strong> the Sebastian Ferrero Foundation,<br />
Dreams Come True of Jacksonville or Broken Hearts of the Big Bend. (Source: Tallahassee<br />
Democrat, 1/3/10)<br />
Former <strong>Blood</strong> Systems President Hayle B. Randolph, BS, MT (ASCP), died Dec. 21 in Phoenix. He was<br />
78. A native of Abilene, <strong>Texas</strong>, and a graduate of Abilene Christian College, he began his nearly 40-year<br />
career in blood banking at Travis County <strong>Blood</strong> Bank in Austin, <strong>Texas</strong>. He joined <strong>Blood</strong> Systems in<br />
1957, serving as executive direc<strong>to</strong>r of centers in Cheyenne, Wyo., and Meridian, Miss., before moving <strong>to</strong><br />
the national office in 1965 where he directed technical operations, plasma center operations, and blood<br />
center operations. Mr. Randolph served as president of <strong>Blood</strong> Systems from 1980 <strong>to</strong> 1990. Additionally,<br />
he led important initiatives for America’s <strong>Blood</strong> <strong>Center</strong>s, AABB, and the <strong>South</strong> Central Association of<br />
<strong>Blood</strong> Banks. Mr. Randolph is survived by his wife, Gwen; their children, Charlie and Susan; four<br />
grandchildren and two great-grandchildren. Mr. Randolph’s family welcomes memorial gifts <strong>to</strong> <strong>Blood</strong><br />
Systems Research Institute, P.O. Box 1867, Scottsdale, AZ 85252-1867, or <strong>to</strong> the Flagstaff Symphony<br />
Orchestra, 113 E. Aspen Ave., Flagstaff, AZ 86001-5263. Expressions of sympathy may be sent <strong>to</strong> Mrs.<br />
Gwen Randolph, 1491 N. Edgewood, Flagstaff, AZ 86004.<br />
A veteran of the blood community, Karen McCauley Indovina passed away on Dec. 23 at Rex Hospital<br />
in Raleigh, N.C. She was 57 years old. Ms. Indovina held posts at the <strong>Blood</strong><strong>Center</strong> of Wisconsin and the<br />
Community <strong>Blood</strong> <strong>Center</strong> in Day<strong>to</strong>n, Ohio, among other organizations. Most recently, she served as manager<br />
of Regula<strong>to</strong>ry Affairs at Talecris Biotherapeutics. She graduated from <strong>South</strong> Side High School in<br />
1970 and attended Jackson State College and graduated from the University of Tennessee at Martin with<br />
a degree in Medical Labora<strong>to</strong>ry Technology. Among her achievements was working with the Food and<br />
Drug Administration in the writing of compliance and regula<strong>to</strong>ry guidelines.
ABC <strong>New</strong>sletter -20- January 8, 2010<br />
MEETINGS<br />
Feb. 19<br />
California <strong>Blood</strong> Bank Society 2010 Regional Seminar, Simultaneous Sessions via<br />
Audioconferencing from <strong>Blood</strong> Source in Mather and the American Red Cross in<br />
Pomona, Calif.<br />
This seminar will feature presentations titled “QC and QA for Apheresis or Why We Do<br />
What We Do”; “100,000 Post Procedure Platelet Count”; a panel discussion on “The Miracle<br />
of Bone Marrow Transplants”; and a session on “Maintaining Collections During<br />
Flu Season!” by various blood center experts. Presented by the Nursing/Apheresis & Donor<br />
Resources Committees.<br />
Register online at www.cbbsweb.org. <br />
CLASSIFIED ADVERTISING:<br />
Classified advertisements, including notices of positions available & wanted are published free of charge for a maximum<br />
of three weeks for ABC institutional members. There is a charge of $100 per placement for ABC <strong>New</strong>sletter subscribers &<br />
$250 for non-subscribers. Notices ordinarily are limited <strong>to</strong> 150 words. To place an ad, contact Deanna Du Lac at the ABC<br />
office. Tel: (202) 654-2917; Fax: (202) 393-5527; E-mail: ddulac@americasblood.org.<br />
POSITIONS AVAILABLE<br />
District Direc<strong>to</strong>r. Life<strong>South</strong> Community <strong>Blood</strong> <strong>Center</strong>s<br />
seeks District Direc<strong>to</strong>r for <strong>South</strong> Florida Region.<br />
Ideal candidate will be responsible for overseeing daily<br />
operations of all branches in region, which include but<br />
not limited <strong>to</strong> maintaining positive hospital/cus<strong>to</strong>mer<br />
relationships within district, as well as community,<br />
communicating with vendors & other entities <strong>to</strong> solve<br />
problems within district & ensuring branches are in<br />
compliance with Quality Assurance, Training & HR<br />
departments. Will act as media spokesperson for Life-<br />
<strong>South</strong>. This individual must have strong verbal &<br />
communications skills, as well as minimum of four<br />
years managerial exp. Position is located in Brooksville,<br />
FL. Submit cover letter & resume <strong>to</strong>:<br />
knhensel@lifesouth.org. Background check req’d.<br />
EOE/DFWP<br />
Technical Writer. Coffee Memorial <strong>Blood</strong> <strong>Center</strong> has<br />
opening for exp. technical writer who will oversee management<br />
& development of documents & document<br />
control system. Position supervises staff of two technical<br />
writers & utilizes document control (database) software,<br />
flowcharting software & basic graphic editing programs.<br />
BS or BA in English, Writing, Communications or<br />
health/medical field or equivalent combination of education<br />
& exp. req’d. Must possess excellent verbal &<br />
written communication skills, good command of vocabulary,<br />
spelling & grammar and attention <strong>to</strong> detail.<br />
Must be knowledgeable of scientific writing principles.<br />
Previous exp. with supervision req’d. Must be able <strong>to</strong><br />
communicate & work collaboratively with wide variety<br />
of people & work with minimal oversight. Good command<br />
of MS Word & PowerPoint req’d. Familiarity<br />
with Adobe Acrobat a plus. Strong preference for applicants<br />
familiar with blood banking & transfusion<br />
services, FDA regulations applicable <strong>to</strong> Biologics &<br />
Drugs, including GMPs & AABB Standards. Occasional<br />
lifting up <strong>to</strong> 50 lbs. Must be able <strong>to</strong> sit & type for extended<br />
periods of time. Must be able <strong>to</strong> bend, kneel &<br />
reach on occasion. Excellent benefits package offered.<br />
For more information & <strong>to</strong> obtain printable application,<br />
please visit our website: www.thegif<strong>to</strong>flife.org. Resumes<br />
& requests for additional information may be submitted<br />
<strong>to</strong> Kathy Mitchell, SPHR by Fax: 806-358-2982 or E-<br />
mail: kmitchell@thegif<strong>to</strong>flife.org. EOE<br />
Reference Labora<strong>to</strong>ry Technician. Kentucky <strong>Blood</strong><br />
<strong>Center</strong> in Lexing<strong>to</strong>n, KY, seeks medical technologist <strong>to</strong><br />
perform & interpret serological procedures on specimens<br />
submitted for compatibility testing or problem<br />
resolution. Will resolve typing problems, antibody problems,<br />
& cross match problems & communicate with<br />
hospitals as needed. 3rd shift, 10:30 p.m. - 7:00 a.m.,<br />
Sunday - Thursday, including on-call rotation. This<br />
position requires MT (ASCP) with minimum two years<br />
recent blood bank exp., MT (ASCP) SBB pref’d. Strong<br />
written & oral communication skills, do-what-it-takes<br />
work ethic & team player attitude req’d. BS in Medical<br />
Technology (MT) or Clinical Labora<strong>to</strong>ry Science<br />
(CLS).<br />
(continued on page 21)
ABC <strong>New</strong>sletter -21- January 8, 2010<br />
POSITIONS (continued from page 20)<br />
Competitive salary, comprehensive benefits including<br />
health/dental/life, LTD, paid vacations/holidays, EAP,<br />
403(b) retirement savings plan & pension plan. Drugfree<br />
and EOE/AAP. For more information or <strong>to</strong> apply<br />
for this position, please visit our website at:<br />
www.kybloodcenter.org.<br />
Labora<strong>to</strong>ry Scientist &/or ASCP Licensed Medical<br />
Technologist. Join San Diego <strong>Blood</strong> Bank Reference<br />
Labora<strong>to</strong>ry & make difference in lives of patients, staff<br />
& community. Work in one of finest cities in America,<br />
sunny San Diego with mountains, beaches & average<br />
temperature of 75 degrees year round! SDBB is not-forprofit<br />
community blood center that provides blood services<br />
for region. SDBB offers ideal location <strong>to</strong> start<br />
career, opportunity <strong>to</strong> take on leadership roles & ability<br />
<strong>to</strong> grow within organization. We are looking for qualified<br />
candidates: California licensed or eligible<br />
Labora<strong>to</strong>ry Scientist &/or ASCP Licensed Medical<br />
Technologist. Specialty in <strong>Blood</strong> Banking pref’d. <strong>Blood</strong><br />
Bank/Immunohema<strong>to</strong>logy exp. (minimum three <strong>to</strong> five<br />
years) & willing <strong>to</strong> relocate. Work independently,<br />
trouble shoot, problem solve & accept responsibility.<br />
We offer generous paid time off program, 100% employee<br />
paid health benefits; pension plan & 403(b). For<br />
more information contact: Marci Swearingen: 619-400-<br />
8320. AA/EOE<br />
Training Manager. Community <strong>Blood</strong> Services, headquartered<br />
in Paramus, <strong>New</strong> Jersey, has immediate<br />
opening for Training Manager in their blood collections<br />
division. Responsible for all aspects of education programs<br />
for all levels of Phlebo<strong>to</strong>mists & Collections<br />
staff, assure clinical orientation & continuing education<br />
of staff, participate in planning, evaluation, validation &<br />
training for implementation of new technology. Requirements<br />
include: Bachelors Degree in Nursing or<br />
Allied Health Science pref’d, three <strong>to</strong> five years training<br />
exp., excellent organization, verbal & written communication<br />
skills. <strong>Blood</strong> banking exp. pref’d. To apply,<br />
please E-mail resume <strong>to</strong>: Careers@cbsblood.org. EOE,<br />
M/F/D/V<br />
Medical Direc<strong>to</strong>r. Life<strong>South</strong> Community <strong>Blood</strong> <strong>Center</strong>s,<br />
Inc. seeks medical direc<strong>to</strong>r with two or more years<br />
of exp. in BB/TM. Position based at corporate headquarters<br />
in Gainesville, FL reports <strong>to</strong> Medical Officer.<br />
Responsibilities of position include providing medical<br />
direction <strong>to</strong> several regional centers in Florida, Alabama<br />
& Georgia with annual whole blood & apheresis collection<br />
of over 225,000 donors. Also included will be<br />
shared medical oversight of donor testing labora<strong>to</strong>ry,<br />
reference lab, cord cell bank & therapeutic apheresis<br />
procedures. Applicant should be board certified in<br />
clinical pathology, hema<strong>to</strong>logy or other suitable specialty<br />
with board certification or eligibility in BB/TM and<br />
have or be eligible for licensure in Florida, Georgia &<br />
Alabama. Please submit cover letter & resume <strong>to</strong>: 4039<br />
<strong>New</strong>berry Rd, Gainesville, FL 32607, Attn: Dr. Kathleen<br />
Sazama or kjsazama@lifesouth.org. Background<br />
check req’d. EOE/DFWP<br />
Medical Direc<strong>to</strong>r. <strong>Blood</strong> Systems, national leader in<br />
blood banking, seeks applications for Medical Direc<strong>to</strong>r<br />
at its corporate office in Scottsdale, AZ. Excellent opportunity<br />
for physician <strong>to</strong> provide medical direction &<br />
expertise for product manufacturing & distribution<br />
initiatives. Position will participate in developing new<br />
programs, delivering state-of-the-art clinical services,<br />
setting medical policies & developing procedures for<br />
relevant programs & services. Candidate will work with<br />
medical direc<strong>to</strong>rs & management staff <strong>to</strong> develop &<br />
ensure delivery of educational programs that meets<br />
needs of medical & technical staff at hospitals served by<br />
<strong>Blood</strong> <strong>Center</strong>s division. Successful candidate will lead<br />
or participate in investigations & develop projects <strong>to</strong><br />
improve blood transfusion policies & services. Candidate<br />
will be req’d <strong>to</strong> have MD or DO degree & be<br />
eligible <strong>to</strong> obtain license in State of Arizona within six<br />
months of hire. Position requires board certification in<br />
Clinical Pathology, Internal Medicine or Pediatrics &/or<br />
board eligibility in Transfusion Medicine. <strong>Blood</strong><br />
Bank/Transfusion Medicine certification req’d within<br />
three years. Fellowship training in blood banking/transfusion<br />
medicine or three years exp. in field for<br />
Transfusion medicine req’d. Previous supervisory &<br />
blood center exp. pref’d. To apply, please submit CV<br />
along with names of three references by 1/29/10 <strong>to</strong>:<br />
<strong>Blood</strong> Systems, ATTN: HR/2009/59, 6210 E. Oak St.,<br />
Scottsdale, AZ 85257 or Fax <strong>to</strong>: 480-675-5780. To<br />
apply on-line, E-mail: jobs@bloodsystems.org. Preemployment<br />
drug testing req’d. EOE M/F/D/V<br />
Direc<strong>to</strong>r Technical Operations. LifeSource <strong>Blood</strong><br />
<strong>Center</strong> is not-for-profit organization & major provider of<br />
products that support Chicago’s blood supply. Life-<br />
Source’s committed professionals believe in core values<br />
of providing reliable & safe blood products <strong>to</strong> community.<br />
LifeSource is made up of quality minded individuals<br />
who demonstrate team work, open communication,<br />
continuous learning & excellent cus<strong>to</strong>mer service. Responsible<br />
for overseeing planning, organizing & general<br />
operations of Manufacturing, Labeling & Quality Control<br />
departments. Assures compliance with SOPs,<br />
regula<strong>to</strong>ry agencies, cGMP guidelines & abides by all<br />
safety & security policies. Position supports all Life-<br />
Source activities which are directed <strong>to</strong>wards selfsufficiency<br />
& goals & strategic operations of organization.<br />
Direc<strong>to</strong>r of Technical Operations will assist<br />
departments in diagnosing operational problems; assist<br />
in resolving them & moni<strong>to</strong>ring results. This important<br />
role will moni<strong>to</strong>r daily activities <strong>to</strong> assure product availability,<br />
QC requirements are met & ensures HLA match<br />
product orders & fractiona<strong>to</strong>r shipments are made. This<br />
(continued on page 22)
ABC <strong>New</strong>sletter -22- January 8, 2010<br />
POSITIONS (continued from page 21)<br />
role manages team approach <strong>to</strong> identification & development<br />
of SOPs, validation pro<strong>to</strong>cols, new projects,<br />
computer upgrades & training. Assures compliance &<br />
accuracy with SOPs is maintained. Position requires<br />
minimum of five years exp. in labora<strong>to</strong>ry management;<br />
blood center exp. req’d. Exp. working in regulated<br />
environment req’d with quality assurance pref’d. Bachelors<br />
in Biological Sciences req’d. BB or SBB req’d.<br />
To apply visit our website: www.lifesource.org or contact<br />
Nancy Sifuentes: 847-803-7845.<br />
Quality Source Consultant. Are you looking for great<br />
career opportunity with stable, mission oriented company<br />
Look no further! <strong>Blood</strong> Systems, national leader in<br />
blood banking industry, is recruiting for Quality Source<br />
Consultant <strong>to</strong> join our team. Under limited direction,<br />
successful candidate will be responsible for providing<br />
quality consulting services related <strong>to</strong> design, delivery &<br />
implementation of quality & compliance related initiatives<br />
internally within <strong>Blood</strong> Systems, Inc. as well as for<br />
blood collection facilities, hospitals, transfusion services<br />
or other external clients. Prior exp. with evaluation,<br />
design, validation & implementation of medical devices<br />
& software in blood establishment environment is a<br />
must! To be considered for this position, successful<br />
candidate must meet all of following requirements:<br />
Relevant Bachelor's degree with advanced certification<br />
in Quality Programs (e.g. CQA, CQM, Six Sigma etc,)<br />
req’d. Thorough knowledge of Quality Management &<br />
Quality Program Development req’d. Prior knowledge<br />
of blood banking industry standards & regulations will<br />
be req’d. Minimum of five year’s exp. in quality/regula<strong>to</strong>ry<br />
leadership position <strong>to</strong> include: Three years<br />
supervisory exp. req’d. National level public speaking,<br />
healthcare, blood banking, or pharmaceutical industry<br />
exp. req’d. In addition, Certification as MT by recognized<br />
certifying agency, SBB, or advanced degree<br />
pref’d. Prior exp. in market research & analysis, marketing<br />
& sales techniques & new business development or<br />
consulting pref’d. Position will require travel approximately<br />
65% of time. <strong>Blood</strong> Systems offers<br />
comprehensive benefits package that includes 401k, full<br />
employer paid pension & much more! For consideration<br />
please submit resume by 1/15/2010 <strong>to</strong>:<br />
jobs@bloodsystems.org ATTN: HR/2009/60. Visit our<br />
website at: www.bloodsystems.org. Pre-employment<br />
drug testing req’d. EOE M/F/D/V<br />
Technical Direc<strong>to</strong>r. United <strong>Blood</strong> Services-Louisiana<br />
seeks exp., results-oriented individual <strong>to</strong> provide blood<br />
center technical oversight for state & lab management.<br />
Successful candidate oversees blood center manufacturing<br />
& technical process <strong>to</strong> assure center-wide<br />
compliance with manufacturing & regulations. Bachelor's<br />
degree in chemical, physical, biological, medical<br />
technology or clinical labora<strong>to</strong>ry science & certification<br />
as Medical Technologist by recognized certifying agency<br />
required. BB or SBB pref’d. LA State licensure<br />
req’d. Five years labora<strong>to</strong>ry exp. & three years supervisory<br />
exp. req’d. Previous blood bank or blood center<br />
exp. pref’d. Competitive salary & excellent benefits<br />
package. Relocation assistance available. Position is<br />
located in Lafayette LA. Send resume w/salary requirements<br />
by 1/15/2010 <strong>to</strong>: HR Direc<strong>to</strong>r United <strong>Blood</strong><br />
Services – Louisiana, P. O. Box 3362, Lafayette, LA,<br />
70502. Pre-employment drug testing req’d. EOE<br />
M/F/D/V<br />
Assistant Medical Direc<strong>to</strong>r. The American Red Cross<br />
<strong>Blood</strong> Services <strong>South</strong>ern California Region in Pomona,<br />
California seeks Assistant Medical Direc<strong>to</strong>r with guidance,<br />
leadership & oversight of all matters relating <strong>to</strong><br />
medical practices & research of blood region. Support<br />
medical services of regional centers. Responsible for<br />
medical policies & procedures of blood region. Moni<strong>to</strong>rs<br />
medical aspects of regional blood centers operations,<br />
including reference labora<strong>to</strong>ries, research, medical<br />
community relations & collections. Provides medical<br />
consultations on transfusion medicine issues <strong>to</strong> regional<br />
physicians & other health care professionals. Qualifications:<br />
M.D or D.O degree with post graduate training in<br />
blood banking/transfusion medicine req’d. Board certified<br />
or eligible in internal medicine, pediatrics or<br />
clinical pathology. Board certified or eligible in blood<br />
banking/transfusion medicine desirable. Knowledge of<br />
current/projected trends in transfusion medicine/blood<br />
banking & hospital health care desirable. Must be licensed<br />
in state of primary site of region and all<br />
banking/transfusion medicine, or related field, or completion<br />
of a blood banking/transfusion medicine<br />
fellowship req’d. Apply On-line:<br />
http://americanredcross.apply2jobs.com/<br />
Quality Direc<strong>to</strong>r II. <strong>Blood</strong> Systems, national non-profit<br />
blood bank seeks professional with strong organizational,<br />
presentation, written & verbal communications skills<br />
for our Quality Direc<strong>to</strong>r II position in St. Petersburg,<br />
FL. Responsible for managing review of quality systems<br />
& compliance in all areas of technical & clinical<br />
operations. Serves as resource <strong>to</strong> operations on quality<br />
issues & participates in Six Sigma & other performance<br />
improvement initiatives. Relevant Bachelor’s degree<br />
and five years of related exp. in regulated industry <strong>to</strong><br />
include three years in quality, regula<strong>to</strong>ry &/auditing<br />
environment & two years of previous supervisory exp.<br />
req’d. Certification as Med Tech or SBB pref’d. CQA,<br />
CQE &/or CMQOE certification within two years req’d.<br />
For consideration, please submit resume via E-mail by<br />
01/15/2010 <strong>to</strong>: jobs@bloodsystems.org. ATTN:<br />
HR/2009/61. We offer competitive benefits package, as<br />
well as relocation & much more! Pre-employment drug<br />
testing req’d. Visit our website at:<br />
www.bloodsystems.org. EOE M/F/D/V<br />
Sr. Medical Direc<strong>to</strong>r – Corporate. <strong>Blood</strong> Systems,<br />
national leader in blood banking industry, seeks Sr.<br />
(continued on page 23)
ABC <strong>New</strong>sletter -23- January 8, 2010<br />
POSITIONS (continued from page 22)<br />
Medical Direc<strong>to</strong>r <strong>to</strong> provide medical & operational<br />
direction <strong>to</strong> our clinical services division. Reporting <strong>to</strong><br />
VP of Clinical Services, this key position will provide<br />
primary supervision & expertise for corporate program<br />
& service initiatives. Position will assist with development<br />
of our product portfolio & clinical services<br />
associated with programs such as stem/progeni<strong>to</strong>r cell<br />
labora<strong>to</strong>ry, transfusion service & HLA labora<strong>to</strong>ry.<br />
Moreover, this position will have primary role in participating<br />
in medical policy meetings & collaborating with<br />
our blood centers & clinical services cus<strong>to</strong>mers. To be<br />
considered for this position, candidates are req’d <strong>to</strong><br />
have: MD or DO & current license (or attained within<br />
six months of hire) in AZ; Board Certification in Clini-<br />
cal Pathology or Internal Medicine; Board Certification<br />
in <strong>Blood</strong> Bank/Transfusion Medicine or eight years exp.<br />
in field of Transfusion Medicine. Qualification preferences<br />
include: American Society of His<strong>to</strong>compatibility<br />
& Immunogenetics certification; five years stem cell<br />
processing exp.; exp. at blood center that collects, tests<br />
& distributes blood products for transfusion; good working<br />
knowledge of complete blood manufacturing<br />
practices. <strong>Blood</strong> Systems offers comprehensive benefits<br />
package that includes matched 401k + company paid<br />
pension, health benefits, relocation & much more! For<br />
consideration please submit resume by 01/15/10 <strong>to</strong>:<br />
jobs@bloodsystems.org. ATTN: HR/2009/58. Visit<br />
our website at: www.bloodsystems.org. Pre-employment<br />
drug testing req’d. EOE M/F/D/V