Carol Baker to Retire from Texoma Regional Blood Center Our Space: Retirement....2 FDA Urges More Carol A

2011 #25 July 1, 2011

INSIDE: Carol Baker to Retire from Texoma Regional Blood Center Our Space: Retirement....2 FDA Urges More Carol A. Baker, MT(ASCP)BB, executive director of Texoma Regional Blood Conservative ESA Center in Sherman, Texas, has announced to the Texoma board and staff that she Doses to Treat Kidney will retire as of Aug. 19. Disease Patients ...... 3 Commentary Rejects Ms. Baker has dedicated the past 18 years to Texoma, working first as a lab tech- XMRV-CFS Theory, But Studies to Continue ...... 5 nician, then moving up to technical director, and finally to her current position as Commentary: Standard executive director, which she has held for the past seven years. Bearers...... 7 Betty Klinck Takes Helm of “I’ve worked here [at Texoma] longer than I’ve ABC Newsletter as New stayed at any place,” said Ms. Baker in a phone inter- Publications Editor...... 8 view with ABC. “I love the blood center and I will Former ABC President miss it every day of my life. I will probably wake up Sends Dispatch from every morning and think to myself ‘What are they Blood Safety Project in Nigeria...... 13 doing at the blood center today?’”

San Francisco Workshop Offers Education, Ms. Baker said that after retiring she plans to spend Networking to ABC more time with her children, grandchildren, and hus- Members ...... 14 band, who also just retired. She said that she and her family like to visit the mountains at their cabin in Red River, N.M.

Her route to the top position at Texoma began when Ms. Baker decided to return to school after working for years in advertising and promotion. She earned her bachelor of science degree in Medical Biology at Southeastern Oklahoma State University in Durant, Okla. She had done her clinical work at Texoma while earn- ing her degree, and a couple of years later, the center asked if she could replace a lab tech. Ms. Baker initially earned a business degree from the University of Ok- lahoma.

“I just fell in love with it,” said Ms. Baker of her first experience working at Tex- oma. “And I had wanted to come work with the blood center for some time.”

Of her accomplishments during her years as executive director, Ms. Baker said that she is proud of how the small center itself has grown over the past few years, as much of its donations are typically gained through off-site blood drives.

(continued on page 4) ABC Newsletter -2- July 1, 2011

OUR SPACE

ABC CEO Jim MacPherson

Retirement

The word can send chills down the spines of many over-60 CEOs. I had been planning to retire in far-off 2015. And then as I watched my board set up a “succession planning” task force earlier this year, that date seemed to me suddenly real and close at hand. But once you start thinking about it, retirement doesn’t sound as frightening and as final as death does.

When I was growing up, people looked forward to retiring to just relax and travel; many still do. But today, with more and more people living healthy and well into their 80s, retirement has taken on a new meaning. Pretty much everyone I know who has retired recently is as busy as ever, just doing something else. It’s as if the word now means, “Yup, I’m done with that; I want to do something different.”

Like many of you, I have my wonderful family to enjoy, but most of my friends are in the blood banking field. So, I doubt retiring will mean being an usher at Camden Yards (where the Orioles play in Baltimore) or a do- cent at the National Gallery – at least not right away. But the word opens a whole new world of possibilities.

Retirement also opens possibilities for organizations. At one of ABC’s meetings in the mid-1990s, healthcare “futurist” Leland Kaiser stated that the biggest obstacle to managed healthcare (meaning consolidations and mergers) was the 55-year-old hospital CEO. That statement was met by nervous laughter from the many blood center CEOs in the room who happened to fall into that very age group.

That doesn’t seem as true today, as we often see the 60-plus hospital or blood center CEO who, recognizing the current realities while having vision for the future that comes with a long career, is leading his or her organization into mergers and consolidations.

Seeing a future without you in it tends to open up another kind of whole new world, one where you are free to see your organization doing better and bigger things as part of larger entity with more resources and talents. It is interesting how one word in your life opens the future to so many personal and organizational opportunities.

[email protected] 6

The ABC Newsletter (ISSN #1092-0412) is published 46 times a America’s Blood Centers year by America’s Blood Centers® and distributed by e-mail. President: Dan A. Waxman, MD Contents and views expressed are not official statements of ABC Chief Executive Officer: Jim MacPherson or its Board of Directors. Copyright 2011 by America’s Blood Centers. Reproduction of the ABC Newsletter is forbidden unless ABC Newsletter Editor: Robert Kapler permission is granted by the publisher. (ABC members need not Publications Editor: Betty Klinck obtain prior permission if proper credit is given.) Business Manager: Leslie Norwood Annual Subscription Rate: $381 ABC is an association of not-for-profit, independent community (Residents, Fellows, and SBB Students: $120) blood centers that helps its members provide excellence in Send subscription queries to transfusion medicine and related health services. ABC provides [email protected]. leadership in donor advocacy, education, national policy, quality, America’s Blood Centers and safety; and in finding efficiencies for the benefit of donors, patients, and healthcare facilities by encouraging collaboration 725 15th St. NW, Suite 700, Washington, DC 20005 among blood organizations and by acting as a forum for sharing Phone: (202) 393-5725 information and best practices. Send news tips to [email protected].

ABC Newsletter -3- July 1, 2011

FDA Urges More Conservative ESA Doses to Treat Kidney Disease Patients

The Food and Drug Administration has issued more restrictive dosage recommendations for erythropi- esis-stimulating agents (ESAs), drugs used to treat certain types of anemia caused by chronic kidney disease (CKD), a condition affecting more than 20 million people.

In a Drug Safety Communication last Friday, the FDA warned that no amount of ESA is risk-free and recommended that they weigh the costs and benefits of using the drug and create individualized treatment plans before prescribing ESA. The agency cited controlled trials that show an increased risk for cardiovascular events, stroke, thrombosis, and death due to ESAs, according to a recent FDA release.

ESAs have been used since 1989 when the FDA approved two popular types of the drug, Epogen and Procrit, to treat anemia caused by CKD and chemotherapy. Subsequently, some doctors used the drugs off-label to treat anemia caused by other conditions. The FDA approved a third ESA, Aranesp, in 2001. Amgen Inc., a Calif.-based drug company, produces all three drugs, although Procrit is marketed by John- son & Johnson’s Janssen Pharmaceuticals, Inc.

ESAs Reduce Blood Need. Past studies from the late 1980s have shown that before the introduction of ESAs, CKD patients required about 8-9 percent of the red blood cell (RBC) supply, said ABC CEO Jim MacPherson. Since then, ESAs have dramatically reduced and often eliminated the need for transfusion in these patients. ESAs are synthetic proteins that mimic the action of the human hormone erythropoietin and spur the production of red blood cells, thus increasing hemoglobin to healthier levels.

Following the FDA’s requirement to add new warnings, ESA labels have now changed to reflect findings of various health risks and that there is no risk-free dosage of the drug. The label has also removed the concept of reaching a “target hemoglobin level” ranging between 10-12 g/dL in CKD patients. Instead, ESA labels now recommend starting ESA treatment in CKD patients with hemoglobin levels less than 10 g/dL, using individualized treatment plans to use “the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions,” according to the recent FDA Drug Safety Communication.

The FDA also recommends that doctors reduce or interrupt the ESA treatment for CKD patients on dialy- sis if their level reaches or exceeds 11 g/dL.

These label warnings for ESAs are not the first. In 2007, FDA required Amgen Inc. to add a “black box warning” to ESAs, the FDA’s strongest warning, to alert patients to the increased risk for blood clots, heart attack, stroke, and death.

With an FDA warning that there is essentially no safe dosage of ESAs, patients may see RBC transfusion as a safer alternative, but no one is sure how that may affect the blood supply. “Current guidelines suggest transfusion of red blood cells when the patient’s hemoglobin is less than 8g/dL if there is no cardiac disease and 10g/dL when there is cardiac disease,” said Celso Bianco, MD, executive vice president of ABC. “The FDA recommendation for ESA is well within these levels. I believe that there may be a slight increase in RBC usage soon after implementation of the FDA recommendations, as renal patients used to higher hemoglobin levels adjust to the recommended levels. After a while, I foresee no substantial change in the demand for red blood cells for these patients.”

These recommendations come after a joint meeting in September 2007 of the Drug Safety and Risk Man- agement Advisory Committee and the Cardiovascular and Renal Drugs Advisory Committee discussing the risks and benefits of ESAs. A discussion followed at the Cardiovascular and Renal Drugs Advisory

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FDA Warns About ESAs (continued from page 3)

Committee meeting in October 2010 about the results of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), according to the FDA release.

TREAT, which enrolled 4,048 subjects between 2004 and 2009, is one of three case-controlled trials that the FDA cited that showed an increased risk of mortality due to using ESAs. The second, the Correction of Hemoglobin and Outcomes in Renal Insufficiency Trial (CHOIR), involved 1,432 patients between 2003 and 2006. The Normal Hematocrit Study (NHS) examined 1,265 patients from 1993-1996, according to the FDA Drug Safety communication.

This is not the first time that the FDA has come down on ESAs. An FDA Drug Safety Communication in February 2010 required Amgen Inc., the Calif.-based drug company that produces these drugs, to develop a risk management program called the risk evaluation and mitigation strategy (REMS).

Under REMS, Amgen developed a Medication Guide to be distributed to patients to inform them of the risks of ESAs. As a part of REMS, Amgen also created ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs), an oncology program for healthcare professionals prescribing ESAs. These FDA recommendations came as a result of studies showing that ESAs can increase the risk of tumor growth, shorten the life of cancer patients, and cause heart attack, stroke or blood clots.

The FDA plans to continue investigating the safety of ESAs, and is requiring Amgen to perform addi- tional trials. The FDA sent out Drug Safety Communications to healthcare providers, and is requiring additions to the existing REMS. (Sources: FDA Drug Safety Communication, 6/24/11; FDA News Re- lease, 6/24/11; Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement, 6/18/10; FDA Drug Safety Communication, 2/26/10; New York Times, 6/24/11) 6

Baker to Retire (continued from page 1)

“We just have a terrific staff who just really identifies with the donor base, and they come back time and time again,” said Ms. Baker. “And they [donors] often ask for who [which phlebotomist] they want.”

Ms. Baker’s employees have just as kind words for her as she has for them. “Our turnover rate is very low since Carol took over as executive director,” said Director of Donor Resources Deedee Morehead. “All of our full-time employees have been here from eight years all the way to 30. Everyone stays because they love it here and they love our leader. So yes, we are all very sad that she is leaving, although we do wish her only the best in her retirement.”

Ms. Morehead added that Ms. Baker is a “true professional” who finds ways to connect with the donors, and to make donating fun, and that she always takes time to listen to employee concerns and handles employees with kindness and compassion.

Whoever replaces Ms. Baker will come into a “great community,” she said, and added that, during her time at Texoma, the challenges she faced were those common to many blood centers, such as recruiting new donors and expanding the center. Ms. Baker emphasized that educating prospective donors is key because, “once they hear what happens to their blood once it leaves them and is on its journey – when you get an opportunity to explain that to them and what it does, they can be hooked for life at that point.”

(continued on page 5) ABC Newsletter -5- July 1, 2011

Baker to Retire (continued from page 4)

Although she is sad to leave her co-workers who she said have become close friends, Ms. Baker said that she takes with her many fond memories, like Texoma’s 35th anniversary celebration last year, which several of the Texoma’s founders attended.

While her time as executive director is ending, Ms. Baker said that she will continue to be active in the blood donation community as an advocate and donor, and that she has recruited many family members and friends to become regular donors. – Betty Klinck, [email protected] 6

Commentary Rejects XMRV-CFS Theory, But Studies to Continue

A group of scientists says it’s time to discard the theory that chronic fatigue syndrome (CFS) has any link to xenotropic murine leukemia virus-related virus (XMRV). However, several studies funded by the Na- tional Heart, Lung and Blood Institute (NHLBI) to determine if XMRV poses a threat to the blood supply will continue.

Scientists from the Nijmegen Medical Centre at Radboud University in the Netherlands, writing in an online commentary in medical journal The Lancet, said three recent papers “provide the final nail in the coffin of the XMRV-CFS story.” One study, write Frank van Kuppevald and Jos van der Meer, “provides convincing evidence that XMRV is a spectacular laboratory artifact generated by recombination of two mouse proviruses during passage of a human prostate-tumor xenograft – i.e., the progenitor of the 22Rv1 cell line – in mice.”

They conclude that “the world has witnessed another false claim that gave new hope to patients with CFS, who are desperately seeking a cause for their suffering.”

Two of the studies were published in Science, the same journal that published a paper in 2009 that has caused a firestorm of debate among retroviral researchers and epidemiologists alike about the purported link between XMRV and CFS. Lombardi and colleagues claimed to have achieved a breakthrough when they discovered XMRV in white blood cells of 67 percent of patients with CFS and 3.7 percent of healthy controls.

In June 2010, AABB issued a bulletin recommending that medically diagnosed CFS patients be discour- aged from donating blood. In December 2010, the Food and Drug Administration’s Blood Products Advisory Committee recommended that blood donors with a history or a diagnosis of CFS be deferred indefinitely (see ABC Newsletter, 12/17/10). Days after the committee meeting, several papers were published that raised the issue of inadvertent contamination of reagents. More than 10 other published studies since the 2009 study by Lombardi et al have been unable to find XMRV in patients with CFS.

Four of those studies, published in the journal Retrovirology, assert that contamination of blood samples and assays by mouse DNA may be the source of the XMRV thought to be found in the blood of patients with CFS and prostate cancer.

To get to the bottom of whether XMRV or related viruses pose any threat to the nation’s blood supply, in November 2009 the Department of Health and Human Services established the Scientific Research Work- ing Group. Chaired by Simone Glynn, MD, chief of the Transfusion Medicine and Cellular Therapies Branch of the Division of Blood Diseases and Resources at NHLBI, the group set about designing

(continued on page 6) ABC Newsletter -6- July 1, 2011

XMRV Commentary (continued from page 5) and coordinating studies to determine the prevalence of XMRV in the donor population, whether it is transmissible by blood transfusion, and if so, what are the pathologic consequences this would pose for the infected recipient. The group is also “focused on standardizing the tests that used to detect XMRV in blood samples and has facilitated the sharing of clinical samples between laboratories,” according to a commentary on the working group in the March issue of Transfusion. Phase I of the study was funded through the NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) program.

Another group, the AABB XMRV Interorganizational Task Force, was formed in 2009, and published a committee report in the March 2011 issue of Transfusion. The report provides an overview of XMRV research to date, the implications of a number of potentially confounding factors, and the potential impact on blood safety.

Citations: Van Kuppeveld FJ, van der Meer JW. XMRV and CFS—The sad end of a story. Lancet. 2011 June 20. [Epub ahead of print]; Simmons G, et al. The Blood Xenotropic Murine Leukemia Virus-Related Virus Scientific Research Working Group: mission, progress, and plans. Transfusion. 2011 Mar;51(3):643-53.6

BRIEFLY NOTED

The European Commission recently published a new report that shows nearly all European Union countries have systems in place for citizens to voluntarily donate tissue and cells without compensa- tion. Donated tissues and cells, such as skin, bones, tendons, corneas and haematopoietic stem cells, are needed to help patients with a variety of conditions, including burns and eye disease. The commission’s 2004 Directive on Quality and Safety for Tissues and Cells calls on member states to take necessary measures to encourage voluntary and unpaid donations. The commission reports on their progress every three years, says an EU news update. This report, “Voluntary and Unpaid Donation of Tissues and Cells,” is the second such report on the subject. Among the findings: 6 About two-thirds of EU countries have taken measures such as advertisements and informa- tional campaigns to promote voluntary, unpaid donations of tissues and cells; 6 Nearly all countries have legislative provisions or guidelines on voluntary, unpaid donation; 6 Incentives and measures to promote voluntary, unpaid donation are well established across the EU. Examples are refreshments, small tokens, reimbursement of travel and medical costs, and time off work for donors; 6 Collectors/suppliers of tissues and cells are mainly public or a mixture of public and private in the EU, Norway, and Liechtenstein; 6 Eleven countries have policies in place to promote self-sufficiency of tissues and cells, and 17 countries have bilateral or other forms of agreements to ensure national supply of tissues and cells; and 6 About half of the countries report regular shortages of tissues and cells, including bone mar- row. The full report can be accessed at: http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm. (Source: Health and Consumer e-News, the European Commission, 6/17/11) 6

We Welcome Your Letters

The ABC Newsletter welcomes letters from its readers on any blood-related topic that might be of interest to ABC members. Letters should be kept relatively short and to the point, preferably about a topic that has recently been covered in the ABC Newsletter. Letters are subject to editing for brevity and good taste. Please send letters to ABC Publications Editor Betty Klinck at [email protected] or fax them to (202) 393-1282. Please include your correct title and organization as well as your phone number.

ABC Newsletter -7- July 1, 2011

Standard Bearers

Several years ago, while covering a Blood Products Advisory Committee meeting for this publication, I received a sideways compliment. After a long and complex exchange between a presenter and several committee members, a seemingly exasperated panelist leaned forward and intoned into a microphone: “I’m not sure what just happened, so I’ll have to wait for the newsletters to tell me.” Commentary As I chuckled along with the rest of the audience, I realized just how much the ABC Newsletter is taken for granted by those who make blood policy. And in the years since, I’ve seen how vital this little weekly is to nearly everyone engaged in the business of collecting, protecting, or promoting that lifesaving sub- stance.

I’m sure some would dispute the idea that the ABC Newsletter is the news standard for the blood community. But I know that those of us toiling in this white marble building on 15th Street have tried to act as if we were the standard bearers. And maybe that’s the important thing.

I have been working on this newsletter in some capacity for more than seven years, six of them either as co- editor (with longtime editor Jane Starkey) or as the editor. That’s 330 issues. But with this issue, my tenure as editor comes to an end. I’ll be focusing on my other duties at ABC.

Through the years, we have tackled big, multifaceted topics and have generated hundreds of summaries of research studies. We’ve reported on the triumphs of our members and have not ignored their foibles. Through it all, we have tried to make the newsletter readable and fair, and we have admitted our mistakes.

We have struggled to figure out those densely written papers, those headache-inducing PowerPoint slides, all to discern the finer points of the issues that impact blood centers and patients. It was in that vein (so to speak) that I wrote (and Celso Bianco, MD, edited) a story about the challenges of detecting bacterial contamination in platelets that was used as an official exhibit by a blood advisory committee. It was a proud day.

I’ve had the honor of sharing these pages with some great writers. I’m thinking about Jane and her detailed regulatory policy stories and witty People items. I’m thinking about Jim MacPherson, whose “Our Space” column is the essential guide to the concerns and interests of blood bankers everywhere. I must also mention the meticulous prose of Anne Carroll, PhD, who gave us 20 great months. And I can’t forget Lauren Larsen’s “Blue Platelet Special” column. If “Our Space” is the heart of the ABC Newsletter, then “Blue Platelet” is its soul. I’m glad I talked her into taking on that responsibility.

I’ve had the luxury of great substantive editing from Dr. Bianco up there on the ninth floor, as well as the keen eyes of our proofers – Lolita Norwood, Lori Beaston, Toni Mattoch, and Abbey Nunes. They have saved me from embarrassment on too many occasions to mention. I must also give a shout-out to all the blood center public relations people I have worked with, many of whom have taken their craft to the level of art.

Of course, I also owe a major debt of gratitude to Jane, who spent 20 years laboriously building this newsletter, word by word, sentence by sentence. She not only taught me the ropes, but also how to braid fibers into ropes.

Now it is my turn to introduce a new standard bearer. Say hello to Betty Klinck, late of a little newsletter called USA Today, where she did admirable work (see story, next page). In the short time I’ve known Betty, I’ve been impressed by her energy, intelligence, and kindness. I leave you in her good hands. But before I go, I must thank you, careful readers, who rely on us for the news and who in turn keep us informed and honest. May you always take for granted the ABC Newsletter.

– Robert Kapler, [email protected] ABC Newsletter -8- July 1, 2011

INSIDE ABC

Betty Klinck Takes Helm of ABC Newsletter as New Publications Editor

America’s Blood Center’s welcomes Betty Klinck as its new publications editor, a position in which she will manage ABC’s flagship publication, the ABC Newsletter.

Ms. Klinck was selected from a pool of some 100 applicants after a six-week hiring process. In her new position, Ms. Klinck will be responsible for creating and editing the weekly content of the newsletter, as well as writing and editing periodic and annual ABC publications, such as Blood Counts.

Ms. Klinck succeeds Robert Kapler, who is resigning from the newsletter after working on it for seven years, three of them as co-editor and nearly three as editor. Mr. Kapler will continue to serve as director of Government Relations for ABC and will contribute government affairs-oriented stories to the newsletter. Ms. Klinck will report to Matt Granato, director of Communications and Member Services.

“We are very excited that Betty has joined the staff of ABC, and we look forward to working with her as we continue to evolve our communications services and expand our reach,” said Mr. Granato. “Even as a recent college graduate, she is quite accomplished and confident.”

Ms. Klinck recently graduated from the University of Maryland with a bachelor’s degree in print journalism from the Philip Merrill College of Journalism. She wrote more than 20 articles both in print and online over a six-month internship with USA Today, covering health- and behavior-related topics for the Life section of the newspaper. Ms. Klinck interviewed dozens of professors, doctors, and other science professionals during her time at USA Today. Among the longer stories she wrote were ones focusing on celiac disease and family nutrition habits.

Most recently, Ms. Klinck interned as a web producer with Education Week, and hopes to put her web and multimedia skills to good use at ABC.

She said she looks forward to speaking with transfusion experts and ABC members to assist her in covering blood donation and transfusion issues and trends, as well as ABC events. Please contact Ms. Klinck with story ideas or tips at [email protected], and add her to your press release distribution lists.6

GLOBAL NEWS

African migrants and refugees in Australia report that they are less likely to donate blood due to feelings of discrimination and their lack of trust in the healthcare system, according to a Deakin University, Australia, press release. The Australian Red Cross and Deakin University jointly conducted a donor study, led by management and marketing Prof. Michael Polonsky, Associate Professor Andre

(continued on page 9) ABC Newsletter -9- July 1, 2011

GLOBAL NEWS (continued from page 8)

Renzaho of the university’s Center of Population Health, and Bianca Brijnath, now at Monash University. The team surveyed the African community during March and April 2010 to learn about their attitudes toward donating blood and the Australian healthcare system. The team’s findings appeared in the May issue of the journal Social Sciences & Medicine. The Red Cross sought to understand why Saharan Afri- can refugees were among the lowest donating groups in Australia. African migrants and refugees reported feeling that the general Australian population holds biases against African blood as “diseased.” They also feel excluded from mainstream media and society, with images of Caucasians being more popular in the media. Africans reported also that they distrust of the healthcare system in Australia, and the report cited some African beliefs that blood is sacred, as well as a fear of blood being wasted or stolen. Professor Polonsky noted in the Deakin University release, that these findings are a detriment to the blood supply as, “African migrants have rare blood types and conditions not seen in the Caucasian population but which can require higher levels of transfusion and targeted blood products.” Conditions, for example, like sickle cell disease overwhelmingly affect the African community. Respondents positively viewed giving blood to those in need, but viewed the blood donation system as a for-profit “blood bank,” rather than a non-profit service, fearing that blood would be sold or wasted in a freezer. The researchers emphasized the need to better reach the African community in donor recruitment, and respondents reported that por- traying Africans in blood donor media efforts as well as instituting multicultural educational forums would help encourage African people to donate. (Sources: Deakin University press release, 6/28/11; WA- today.com.au, 6/28/11) 6

INFECTIOUS DISEASE UPDATES

BABESIOSIS

Infectious disease experts say that many patients unknowingly infected with Babesia may be donating blood, according to a story in the June 20 issue of The New York Times on the spread of the tick- borne disease. Blood centers ask prospective donors on a questionnaire if they ever had babesiosis, a malaria-like disease caused by Babesia sp., a parasite transmitted by ticks. Currently, there are no blood donor screening assays licensed by the Food and Drug Administration. “We are very worried about it and are doing everything in our power to address this,” Sanjai Kumar, chief of the FDA’s emerging pathogens laboratory, told the Times. Babesiosis is the most frequently reported infection transmitted through transfusion in the US, with an estimated 70 to 100 cases in the last 30 years, according to the American Red Cross. (Editor’s note: There was one transfusion-associated death attributed to Babesia microti, the disease resulting from infection by the Babesia sp parasite, in 2010, says the FDA). In New York City, six transfusion-associated cases of babesiosis were reported in 2009, and between 1999 and 2007, several infants in Rhode Island developed babesiosis following blood transfusions. The spread of Babesia in New England prompted the Rhode Island Blood Center to begin using a new experimental test to screen blood for the parasite. Meanwhile, experts urge blood transfusion patients and their doctors to be aware of symptoms of babesiosis, which can occur up to nine weeks after a transfusion. Symptoms include fever, sweats, chills, headache, fatigue, and muscle aches and pains. A diagnosis can be confirmed through blood testing. People at increased risk of complications include patients with compromised immune systems, those who have had their spleens removed, and those with lymphoma or HIV or who are being treated for cancer. If left untreated, babesiosis can lead to kidney, lung, or heart failure. B. microti is transmitted by Ixodes scapularis ticks (also called blacklegged ticks or deer ticks). Tick-borne transmission primarily occurs in the Northeast and upper Midwest of the US, especially in parts of New

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INFECTIOUS DISEASE UPDATES (continued from page 9)

England, New York State, New Jersey, Wisconsin, and Minnesota. More recently, Babesia has spread to the Lower Hudson Valley of New York and in coastal areas of the Northeast, a government agency says. Although Lyme disease has been endemic in parts of the Lower Hudson Valley for some two decades, the disease babesiosis has only been recognized in the area since 2001, according to a report released in May by the Centers for Disease Control and Prevention. The number of Lower Hudson Valley residents diagnosed with babesiosis increased 20-fold, from 6 to 119 cases per year from 2001-2008, compared with a 1.6-fold increase for the rest of New York. In areas where Lyme disease is endemic, babesiosis also is becoming very common, Peter Krause, MD, senior research scientist at the Yale School of Public Health, told the Times. In a study of Block Island, R.I. residents, Dr. Krause found babesiosis to be just 25 percent less common than Lyme disease. There is little data to suggest why the parasite is spreading but more slowly than Lyme disease. One theory is that Babesia is carried in mice, which don’t tend to travel far afield. The bacterium causing Lyme disease, Borrelia burgdorferi, can be carried by birds. (Source: The New York Times, 6/20/11) 6

MEMBER NEWS

Kentucky Blood Center, Lexington, Ky., is one of 500 finalists in Toyota’s 100 Cars For Good contest, which will donate a Toyota vehicle to 100 non-profit organizations. Each day, beginning May 9, Toyota has been featuring five non-profit organizations on the contest’s Facebook page where people can vote for the organization that they feel deserves to win a new Toyota vehicle. On July 8, the page will feature Kentucky Blood Center, so that the public can vote for it to receive a new car. Kentucky Blood Center encourages not only local residents, but also all ABC members to get on Facebook on July 8 and vote for the center to receive a new Toyota Highlander. Should the center receive the most votes, it will use the new car to deliver blood products to area hospitals. Kentucky Blood Center is the largest FDA licensed blood bank headquartered in Kentucky, and last year distributed nearly 130,000 blood components. To vote for Kentucky Blood Center to receive a new Toyota Highlander, please visit the contest Facebook page on July 8, at: http://www.facebook.com/toyota. To learn more about the center you can visit www.kybloodcenter.org. (Source: Kentucky Blood Center press release, 6/28/11)

AABB recently renewed the accreditation status of the Northern California Community Blood Bank (NCCBB) following an on-site assessment. The assessment determined that the level of technical and administrative performance at the facility, based in Eureka, Calif., meets or exceeds AABB standards. In other NCCBB news, the Consultation Service of California’s Division of Occupational Safety and Health, better known as Cal/OSHA, has presented the blood center with a Golden Gate Partnership Recognition for implementing an injury and illness prevention program. The Cal/OSHA Consultation Service visited the blood center in May. “The blood center staff are proud of the renewed accreditation from AABB and the Golden Gate Recognition from Cal/OSHA.,” said Thomas Schallert, NCCBB administrator. “Our employees and managers want to provide a safe and adequate blood supply and they want to do it in an environment that is safe for blood donors and staff. We have great support from our volunteer board of directors, and all of us working together have helped accom- plish the accreditation and recognition.” (Source: NCCBB press release, 6/24/11) 6

ABC Newsletter -11- July 1, 2011

FABC NEWS

BloodSource, Sacramento, Calif. and Carter BloodCare, Bedford, Texas, have shown their com- mitment to maternal-fetal health by signing on to sponsor the Foundation for America’s Blood Centers and the Preeclampsia Foundation’s “Saving Grace: A Night of Hope and Gratitude.” Each of the centers has donated $5,000, the “Foundation Friend” level sponsorship. The gala dinner, to take place on Nov. 12 at the Hilton New York Grand Ballroom, New York, will benefit the two foundations and their life-saving work on behalf of babies and their mothers who develop preeclampsia during pregnancy. Preeclampsia is the leading cause of maternal-fetal death around the world causing a sudden spike in the woman’s blood pressure and possibly causing seizures, strokes, multiple organ failures, and death of mother and/or baby. (See ABC Newsletter, 5/13/11). Preeclampsia occurs in 5 percent of all preg- nancies with no known cure, and women who develop the condition, as well as their babies, often need blood transfusions to survive. New moms and their babies are one of the groups requiring the most blood transfusions. FABC President and Chief Ambassador Lauren Larsen, who is co-chairing the event, battled a life threatening case of preeclampsia in the ninth month of her pregnancy. “Mothers and babies touch our hearts. When they suffer because of preeclampsia it breaks our hearts,” said BloodSource CEO and FABC Board of Directors member, Mike Fuller. “From Lauren Larsen we’ve learned that preeclampsia can be horrible and sometimes fatal, and can significantly impact the blood supply. BloodSource is a “Saving Grace” sponsor because it will help mothers and babies – and the blood supply. We hope, and challenge you to help, too.” To become a sponsor or to learn more about the event, please visit the event website http://savinggrace.preeclampsia.org/. (Sources: “Saving Grace” website; ABC Newsletter, 5/13/11). 6

COMPANY NEWS

Baxter International Inc. announced last week that the Committee for Medicinal Products for Hu- man Use (CHMP) of the European Medicines Agency has issued a “positive opinion” to extend the use of one of its intravenous immunoglobulin (IVIG) products for the treatment of multifocal motor neuropathy (MMN). With adoption by the European Commission, Baxter will receive marketing au- thorization for KIOVIG for an MMN indication in all European Union member states, which the company says is “the first centrally-licensed indication for an immunoglobulin preparation for MMN.” KIOVIG was approved in Europe in 2006 and has been available in the US since 2005, marketed as Gammagard Liquid [Immune Globulin Intravenous (Human)]. MMN is a rare autoimmune disorder char- acterized by progressive weakness in the limbs, leading to difficulty with simple manual tasks. If left untreated, MMN often progresses to more severe weakness, including muscle atrophy or involuntary twitching. The positive opinion is based on two prospective, clinical efficacy studies in patients with MMN, both showing maintenance of muscle strength and improved functionality. Adverse events were reversible and consistent with those seen in other KIOVIG indications, with no serious adverse events. “With today’s CHMP recommendation, Baxter looks forward to offering patients suffering from MMN a licensed treatment option to relieve their symptoms of limb weakness and motor dysfunction,” said Pro- fessor Hartmut Ehrlich, vice president, Global Research and Development, for Baxter’s BioScience business. “Baxter remains committed to building upon its long history and proven experience with IVIG therapy to advance treatment in targeted neurological disorders, such as MMN.” (Source: Baxter press release, 6/24/11) 6

ABC Newsletter -12- July 1, 2011

STOPLIGHT: Status of America’s Blood Centers’ Blood Supply

Percent of Regional Inventory at Total ABC Red Cell Inventory 2 Days Supply or Less, June 29, 2011

1% 1% 3% 2% 4% 3% 12% 24% 20% 2% 21% 28% 22%

3% 0% 68% 17% 74% 67% 73% 70% 12% 67% 10% 0% 0% 3% 3% 17% 10% Total East Midwest South West 2% 5% 3% 3%

11-May 18-May 8-Jun 15-Jun 22-Jun 29-Jun Daily Updates are available at: Red (1 day or less) www.AmericasBlood.org Yellow (2 days) Green (3 days or more) No Re por t

PEOPLE

Larry Frederick, long-time blood donation advocate and ABC friend, will be recognized for his service to the community before the San Francisco Giants baseball game on July 5. Mr. Frederick, the namesake of ABC’s “Larry Frederick Award” for contributions to the volunteer blood community, will be recognized in a pre-game announcement and escorted across the field along with six others who have served both their local communities and the nation. The pre-game announcement is part of Latter- Day-Saints Night (LDS Night), an annual event held by the Church of Jesus Christ of Latter-Day Saints at the Giants stadium. The church says this year’s LDS night is “a celebration of LDS champions in the community” to acknowledge “service that is quietly performed” in the Bay area. Mr. Frederick has been a blood donation advocate ever since blood transfusions from more than 100 people saved his life after a drunk driver struck him while on-duty as an Oakland, Calif. police officer. In 1996, Mr. Frederick founded “Life Across America,” a cross-country bike ride and blood donation drive, which in its first year collected an astounding 75,000 units of blood. “I don’t know how to explain it, but I’m driven from within to try to payback, although it’ll never really happen, all of the 110 donors that I don’t know who saved my life… but every time I meet a new donor it’s like thanking the original donors,” said Mr. Fre- derick over the phone. He noted that this night is not about him, but rather about all of those who “give the gift of life,” through various service. This LDS Night recognition comes during the largest interfaith blood drive, held by the Diocese of Oakland, the Church of Jesus Christ of Latter-Day Saints, and the American Red Cross during July throughout the Bay area of California, said Mr. Frederick. “I believe that my faith in God and my faith in Jesus Christ is why I’m still alive today,” said Mr. Frederick when asked about the role of his faith in his blood donation mission. (Sources: LDS description of event; 6/01/11; Life Across America website) 6 ABC Newsletter -13- July 1, 2011

Former ABC President Sends Dispatch from Blood Safety Project in Nigeria

Longtime blood banker and former ABC president, Tom Schallert, is part of a team that is working to help the people of Nigeria realize the dream of a safe and adequate blood supply.

Mr. Schallert, administrator of Northern California Community Blood Bank, said in an e-mail to ABC on Wednesday that the team was making “final preparations for an intensive two-week training program in transfusion medicine. We are covering transfusion medicine from vein to vein.”

The program is being offered at Uyo University Teaching Hospital (UUTH) in the city of Uyo, located in the Nigerian state of Akwa Ibom. According to Mr. Schallert, the demand for blood in Nigeria is three times the supply and every year people die because of blood shortages. The national blood service, which has been in operation only since 2004, cannot meet the need.

“Months of preparation have gone into this effort, which fol- lows our assessment last year and our choice to use UUTH as Florence Amiboji shakes hands with Tom the initial training center,” Mr. Schallert said in his dispatch Schallert during a ribbon-cutting ceremony, as to ABC CEO Jim MacPherson. “The first week involves Rotary District Governor Obafunmiso training trainers at UUTH, who will in the following two Ogunkeye, left, and Warren Kaufman from weeks train the staff at UUTH along with staff at various the Safe Blood Africa Project, look on. hospitals from throughout the Akwa Ibom state along with others from other states around Nigeria.”

Aside from Mr. Schallert, the team includes Dr. John Edward Watson-Williams, medical adviser for Safe Blood Africa; Chris Gresens, MD, from BloodSource; Warren Kaufman, from Carmel Valley Rotary and co-founder of Safe Blood Africa; and Anthony Ajayi, donor recruiter from Lagos University Teaching Hospital.

Mr. Schallert has been working with Rotary International, Global Healing, Safe Blood Africa, and Blood Innovations on the Nigeria blood safety project for more than a year. For their part, Rotary clubs in Cali- fornia have been working to procure equipment such as refrigerators, generators, and voltage stabilizers to Nigeria.

On Thursday, Mr. Schallert made a side trip to Ibadan for the commissioning of a blood bank refrigerator at Jericho Specialist Hospital in Ibadan, Oyo State, Nigeria. “The governor’s wife, Her Excellency Flor- ence Amiboji, was in attendance and cut the ribbon on the refrigerator,” Mr. Schallert said in a dispatch. Rotary Club of Eureka, Calif. where his blood center is based, wrote the matching grant and provided the primary funds for the refrigerator, he added.

Mr. Schallert acknowledged “contributions from blood centers across the USA,” including training supplies. He also gave thanks for support from Carter BloodCare, in Bedford, Texas; the Association of Donor Recruitment Professionals; Memorial Blood Centers’ Jed Gorlin, MD, based in Minneapolis, Minn.; Jeff Busch and his Safe Blood For Africa team; the Nigerian Blood Transfusion Service; Carid- ianBCT; the government of the Akwa Ibom State; Rotary International; and UUTH. ““Funding for the project comes from Global Healing but this would not have gotten off the ground if not for the vision of Cathy Bryan, Mike Fuller, and Vince Yalon,” he said. Mr. Schallert added that “here are many other sup- porters and we are looking at this as the initial start and more help will be needed down the road.”

(continued on page 14) ABC Newsletter -14- July 1, 2011

Nigeria Project (continued from page 13)

Mr. Schallert’s blood center and three other California blood banks – BloodSource, headquartered in Mather; Blood Bank of the Redwoods, headquartered in Santa Rosa; and Stanford Blood Center, part of the Stanford University School of Medicine, in Palo Alto – have been part of an alliance, Blood Innova- tions, for more than a decade (see ABC Newsletter, 10/29/11).

Representatives from the four centers and Safe Blood Africa developed a three-pronged project for Nige- ria. One goal is to provide equipment, technology, and supplies to blood centers there. A second is to create a training and educational program that will enhance the knowledge and skills of Nigeria’s healthcare personnel. And a third goal is to work with Nigerian colleagues, who will then disseminate the materials and information to other healthcare workers there. 6

LEGISLATIVE NEWS

A federal appeals court on Wednesday upheld the constitutionality of possibly the most fiercely debated provision of the Obama administration’s healthcare reform law, ruling that Congress can require Americans to carry insurance coverage. In backing the individual mandate, the US Court of Appeals for the Sixth Circuit in Cincinnati became the first appellate court to rule on the initiative and also marked the first time a Republican-appointed judge has sided with the administration on the law’s constitutionality. “We find that the minimum coverage provision is a valid exercise of legislative power by Congress under the Commerce Clause,” Judge Boyce F. Martin Jr., a Democratic appointee, wrote for the majority. He was joined by Republican appointee Jeffrey Sutton. The 2 to 1 ruling was hailed by the Justice Department and administration allies, who called it an important bipartisan test of the law’s ability to withstand numerous legal challenges. Opponents of the healthcare act disputed the ruling’s signifi- cance, calling it one incremental step in a legal struggle widely expected to wind up at the Supreme Court. “It’s an unfortunate decision,” David Rivkin, a lawyer representing 26 states in a Florida-based lawsuit that also challenges the law, told The Washington Post. “By the time this gets to the Supreme Court, it’s not going to matter which decision was first or second,” added Mr. Rivkin, who predicted that the law will be overturned. More than 30 lawsuits have been filed since the Patient Protection and Affordable Care Act was passed by Democrats in March 2010, resulting in several rulings by lower-court judges that, until now, have cleaved along partisan lines. Lawyers for the plaintiffs in the Sixth Circuit case said they will appeal directly to the Supreme Court but acknowledged that the justices probably will not take the case right away. (Source: The Washington Post, 6/29/11) 6

San Francisco Workshop Offers Education, Networking to ABC Members

Another year, another successful Fund Development, Communications, and Donor Recruitment workshop for members of America’s Blood Centers (ABC). Blood Centers of the Pacific hosted the workshop in San Francisco, which welcomed more than 80 participants with warm weather and sunny days. The workshop kicked off on Monday, June 20, with fund development topics.

Blood center staff learned about the latest news from the Foundation for America’s Blood Centers and participated in a brainstorming session to gather information about blood center initiatives in need of national funding. The afternoon focused on blood center health initiatives that attract both blood donors and foundations seeking to improve the community’s health, the impact of the recession on fundraising and mitigating strategies, and ways for maximizing the relationship with corporate contributors.

(continued on page 15) ABC Newsletter -15- July 1, 2011

San Francisco Workshop (continued from page 14)

Tuesday was devoted to social media, an ever-growing communication medium for non-profits that is largely unexplored by blood centers. Professional and blood center speakers presented on the best practices in the non-profit social media world and on engaging blood donors via social media without breaking the budget.

“We never seem to be done with training and educating our members on the power of social media,” said Matt Granato, director of Communications and Member Services at ABC. “It’s one of the most requested workshop topics, and for a good rea- son: it’s constantly evolving and changing. Blood centers want to stay up-to-date and ensure they are not left behind, not just by technology, but by their younger and tech-savvier blood donors. Expect this topic to come up again, not just at communications and donor recruitment workshops, but at HR workshops and CEO and senior leadership meetings,” he added.

Sher Patrick, marketing manager for Wednesday began with an issue new to many in the room: how Community Blood Center (Dayton, Ohio) to communicate needs to donors, the media and the general and emcee for part of the workshop, public in a time of ample blood supply. Presenters discussed made sure no one missed a beat. communications strategies that focused on efficient collections and emphasis on right donor, right type, and right time.

Attendees also had a chance to “ask the experts,” as both Dr. Nora Hirschler and Dr. Leon Su made them- selves available to bring into perspective and convey the right information on some of the medical issues affecting blood banking today. As one marketing participant put it: “Outstanding information! Having MDs speak to us validates our jobs in communicating to the public.”

The last day saw a new approach to presentations, with an all-morning, seven-speaker panel on donor incentives and giveaways. The Workshop Committee would like to thank host Blood The presenters’ blood centers spanned the Centers of the Pacific and this year’s sponsors for their whole spectrum of incentives, from none or generosity and support. To find out more about how the sponsor companies can help your blood center, visit very little, to frequent or “every donor, www.americasblood.org/go.cfm?do=Page.View&pid=367 every day.” The goal of the panel was to demonstrate how different strategies work, and included costs and results.

Extracurricular activities included a networking reception and a sunset cruise of the San Francisco bay. Presentations will be posted shortly on the ABC Members’ website at members.americasblood.org under Communications and Member Ser- vices > Workshops. 6 ABC Newsletter -16- July 1, 2011

CLASSIFIED ADVERTISING

Classified advertisements, including notices of positions available and wanted, are published free of charge for a maximum of three weeks for ABC institutional members. There are charges for non-members: $114 per placement for ABC Newslet- ter subscribers and $279 for non-subscribers. Notices ordinarily are limited to 150 words. To place an ad, contact Leslie Norwood at the ABC office. Phone: (202) 654-2917; fax: (202) 393-5527; e-mail: [email protected].

POSITIONS AVAILABLE:

Laboratory Operations Supervisor. Cascade Regional Lab Specialist – Consultation and Reference Lab, Blood Services in Tacoma, Wash. has a full-time posi- Gulf Coast Regional Blood Center. Responsibilities: tion available for a Laboratory Operations Supervisor. perform, document, and interpret tests necessary to This position supervises frontline staff including partici- resolve complex serological problems; perform antigen pating in interviewing, hiring, training, mentoring and screening to locate antigen-negative blood; prepare wet providing ongoing performance feedback. Assures labo- samples for educational purposes; participate in QC and ratory operations are efficient including monitoring staff QA improvements within the department; perform, scheduling and work practices, identifying and imple- interpret, and document in SafeTrace routine donor menting process improvement opportunities and labor serological testing; record, place and fill orders for budget. Assures all quality and regulatory standards are antigen-negative red blood cells in SafeTrace; prepare met. Qualifications: baccalaureate degree in medical washed and deglycerolized RBCs; enter rare cell and technology or biological science, with 5+ years’ experi- serum samples into Access database. Education and ence in blood center, transfusion medicine, cellular expe-rience: MT/MLS, BB or SBB and minimum of one therapy, clinical laboratory or related field. year experience in blood banking and immunohe- MT/MLS/SBB (ASCP) preferred. MLT may be consid- matology; or certificates, licenses, registrations ered with relevant experience. Demonstrated familiarity MT/MLS – ASCP or equivalent certification required with quality assurance requirements, blood banking, cell MT/MLS BB/SBB (ASCP or equivalent) strongly pre- processing and cryopreservation, sterile technique and ferred. Apply at www.giveblood.org. safe handling of potentially infectious human Manager, Data Administration, America’s Blood blood/tissues. Demonstrated knowledge of cGMPs, Centers. Exciting opportunity to help manage and im- CBTPs and principles of QA/QC. Working knowledge plement a cutting-edge technology that assures that of AABB and related FDA regulations. Minimum of patients get the blood they need and measures clinical three years’ of relevant supervisor experience. Excellent outcomes and hemovigilance markers, all while lower- benefits including medical/dental/vision/life/LTD. Four ing blood costs and waste. The software also links donor weeks’ vacation per year. Medical/dental starts the first data to the patient for a true vein-to-vein monitoring of the month after hire. Pension plan fully paid by em- system. Position will provide management, support, and ployer. Submit resume and salary history to: HR guidance for all aspects of ABC’s Data Warehouse Manager, Cascade Regional Blood Services, 220 S. I projects, including the continued promotion, develop- Street, Tacoma, WA 98405. email: [email protected] or fax to (253) 572-3698. Please visit the careers section of our ment, and enhancement of the Appropriate Inventory website www.crbs.net to apply. Resumes can be Management (AIM) software. Provide the members and emailed to [email protected] or faxed to (253) 572-3698. their client hospitals with training opportunities on the use of AIM Modules I and II, as well as the Data Ware- house donor project. A bachelor’s degree in science or a Project Manager, Management Information Sys- healthcare field is required. Having leadership experi- tems, Gulf Coast Regional Blood Center. Act as ence in hospital transfusion services is also a primary project manager of center wide and departmen- requirement. Excellent skills in writing and communica- tal projects. Identify stakeholders; coordinate validation tion, project planning, development and implementation, activities; coordinate training and implementation; and issues management are needed. Some travel is re- monitor costs, schedules, performance; perform business quired. To apply, please e-mail your resume to analysis relevant to projects; and create and implement [email protected]. project plans, validation plans, SOPs. Education and Medical Director. American Red Cross is seeking a experience: bachelor’s degree; MBA preferred. Mini- Medical Director for our Indiana/Ohio Blood Region mum of seven years’ of progressively responsible based in Fort Wayne, IN. This is a full time position experience with direct oversight of programs, projects, and/or task management, preferably in a regulated envi- (continued on page 17) ronment. Certificates, Licenses, Registrations: Project Management Institute (PMI) certification desirable. Apply at www.giveblood.org.

ABC Newsletter -17- July 1, 2011

POSITIONS (continued from page 16) tional standards. To apply, please e-mail your resume to [email protected]. with relocation assistance provided. Qualifications: MD 6 Data Analyst, NYC. Assists Quality and Reg- or DO degree with post-graduate training in blood bank- ulatory Affairs and Operations in collection ing/transfusion medicine is required. Must be board and analysis of quality data to determine op- eligible or certified in clinical pathology, hematology. portunities for improvement and to generate Board eligible or certified in blood banking/transfusion actionable reports. Provides guidance and data medicine. Must be licensed in the state of the primary management support to quality and operations site of the region and all states served by the region. Job in the appropriate collection and analysis of Summary: Responsible for guidance, leadership, and data. Requirements: bachelor’s degree required oversight of all matters relating to the medical practices in analytical background. One to two years’ and research of the blood region. Oversee medical ser- experience in processing data preferred. Ad- vices of the regional centers. Responsible for all medical vanced knowledge and significant experience policies and procedures of the blood region. Coordinate with Microsoft Excel, Microsoft Access, and medical communications between the blood services PowerPoint required. Strong analytical skills; region and the local and national medical community, ability to create presentations that accurately and with NHQ. Support the goals and objectives of the depict data; excellent verbal and written com- organization by providing accurate and timely medical munication skills. Experience with statistical and technical consultation in transfusion medicine to all process control experience very desirable. To operational areas of the region and as appropriate to its apply, please e-mail your resume to EACa- customers. Promote the image of the Red Cross products [email protected]. to the regional medical community. Interested candi- dates may submit resume/CV to Lisa Newell 6 Quality Assurance Specialist, Long Island, [email protected] or call for more information New Jersey, Westchester, Manhattan loca- (651)290-8952.https://americanredcross.apply2jobs.com tions. Provide guidance, support, and oversight to operations and other functional groups The New York Blood Center (NYBC) has a number of within NYBC. Support and assist management positions open: in the Quality and Regulatory Affairs division in all activities related to compliance monitor- 6 Director, Cord Blood Quality, Long Island ing, Standard operating procedure (SOP) City location. Provide oversight, support, and review, and continuous improvement. Under guidance in quality and regulatory issues to the the guidance of direct supervisor, work to en- National Cord Blood Program. Oversee quality sure that specific assigned region of NYBC is requirements in all National Cord Blood Pro- compliant. Cooperate with auditors as needed. gram areas. Manage National Cord Blood Requirements: bachelor’s degree required, Program processes to meet FDA cGMP and preferably in biological sciences, or compara- FACT standards. Function as the liaison with ble education/experience combination. the corporate internal auditor program. Re- Working knowledge of regulations and stan- sponsible for making recommendations and dards applicable to blood and tissue monitoring current and future standards and establishments. Minimum one year of experi- implementing training procedures and prac- ence in blood banking, transfusion services, tices. Requirements: bachelor’s degree biologics, etc. Minimum two years’ ex- (minimum) with master’s degree desirable. perience in quality-related activities. Experi- Experience with Six Sigma or equivalent pre- ence in conducting audits desirable. Excellent ferred. Ten years’ experience in quality in a written and oral communication skills. Atten- regulated environment, with five years of man- tion to detail. Able to conduct limited travel agement experience in quality. Experience when necessary. Ability to think critically and with cell manufacturing required. Experience make decisions related to compliance within in the preparation and filing of biological li- the blood establishment. Ability to perform cense applications helpful. Detail oriented. root cause analysis. To apply, please e-mail Excellent communication skills required. your resume to EACa- Working knowledge of prevailing laws and regulatory requirements, cGMPs, and interna- [email protected]. 6