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South Texas Blood & Tissue Center to Get a New CEO

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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 />

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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

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