INSIDE: Octagam Expected Back on the Market in European ... · director of Harvard’s Center for...

2011 #15 April 22, 2011 Octagam Expected Back on the Market in European Union Soon INSIDE: Our Space: Meta-Leaders

.....................................2 The Committee for Medicinal Products for Human Use of the European Medi-cines Agency (EMA) recommended last week that the marketing suspension be lifted for both Octagam 5% and Octagam 10% in the European Union. The state-ment was based on safeguards implemented by Octapharma, the maker of the immunoglobulin intravenous product.

Community Blood Services in NJ Names New Medical Director, Lab Manager, Financial Adviser .........................3

Review of Studies Finds

that Noneconomic Caps Reduce Liability Costs….....................................4

Though the US Food and Drug Administration issued no announcement regarding Octagam at press time Friday, lifting the EU suspension will most likely help pave the way for the product’s return to the US market. Study: Hemoglobin

Deferrals Have a ‘Strong Effect’ on Donors..........5 The EMA recommendation has been forwarded to the European Commission for

the adoption of a legally binding decision. It is expected that Octagam will again be sold in EU countries shortly after the adoption of the European Commission decision in coming weeks.

Many Frequent Donors Are Iron Depleted, Study Finds ............................7

Benefit Concert Will Help FABC Improve Blood Services in Haiti..........11

Adverse Events. Last year, Octagam had to be pulled off the market in both the US and the European Union following an unexpected increase in reports of thromboembolic reactions, including stroke, heart attack, and pulmonary embo-lism, in patients receiving the medicine (see ABC Newsletter, 10/8/10).

Suncoast Hosts South Korean Medical Technologist ...............12

The increase was linked to problems with the medicine’s manufacturing process. In his Inside Octapharma e-mail blast this week, Flemming Nielsen, president of Octapharma, said that testing and analysis by the company, working in tandem with FDA, shows that the root cause of the problem was related to the presence of coagulation Factor XIa. “Corrective actions have been implemented and their impact has been extremely encouraging,” he said.

As part of its recommendation, the EMA said that a test must be performed to detect factor XIa or other substances that can cause thromboembolic events before batches are released. Octapharma also will carry out post-marketing studies as soon as the medicine is being sold again. Octagam is used to treat patients with weakened immune systems, including peo-ple with primary immunodeficiency syndrome, and children born with acquired immune deficiency syndrome. It is also used in people with certain immune disor-ders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.

(continued on page 8)

ABC Newsletter -2- April 22, 2011

OUR SPACE ABC CEO Jim MacPherson Meta-Leaders

Last week, Ruth Sylvester, who is ABC’s director of Regulatory Services and coordinates member disaster planning and response, gave high praise to a disaster preparedness workshop she had just attended. The work-shops (http://meta-leadershipsummit.org) are being presented around the country as a result of a partnership between the Centers for Disease Control and Prevention (CDC) and Harvard’s National Preparedness Leader-ship Institute. Ruth was especially struck by the lead presenter, Harvard’s Leonard Marcus, PhD, whose “meta-leader” defines someone who mobilizes people and organizations to collaborate in times of crisis. It’s a small world. In the mid-1990s, ABC, the American Red Cross, and AABB hired Lenny Marcus, PhD, as director of Harvard’s Center for Healthcare Negotiation, to try and defuse the increasing tensions between organizations, especially ABC and the Red Cross. Over the course of 18 months, Lenny became my de facto executive coach and I learned much. I also served as a case study for his evolving theories on leadership. Lenny clearly understood “leaders with power” – those whose authority is based on a position with leverage, such as the leader of a major country, large corporation, or esteemed non-profit. Whether the individual is inspirational or not, such leaders hold sway by virtue of what they lead. What fascinated Lenny, however, were leaders with no real powerbase, but who could move people and other organizations to support a com-mon cause. How does a leader “without power but with huge responsibility” motivate others to work together to solve big problems? He believed that the actions of such leaders are driven by the integrity of their values, as well as the social worthiness of and passion for their cause. These and other characteristics are acknowl-edged by others who support the cause and will follow someone with a clear vision as to how it can be accomplished. If this sounds “metaphysical,” it is! But over the years, and in the wake of 9/11, Lenny and his associates have successfully packaged a theory into practical training for those with heavy responsibilities in times of crisis but with few troops under their direct command. While the goals of the “Meta-Leadership Summits” are in disaster preparedness, exposure to Dr. Lenny Marcus in any context can be a moving experience. Any would-be leader in blood banking should learn from the master how to move mountains ... especially when you only have shovel.

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Community Blood Services in NJ Names New Medical Director, Lab Manager Blood Center Also Hires Pascal George as Financial Adviser Community Blood Services (CBS), in New Jersey, recently announced that Millicent Sutton, MD, has been named its new medical director and that Denden Alcantara, MT(ASCP)SBB, has become the man-ager of the blood center’s Immunohematology Reference Laboratory. The blood center, headquartered in Oradell, also announced that Pascal George has accepted a position as senior financial adviser. Millicent Sutton, MD. Dr. Sutton has more than 20 years of experience in the fields of pediatric hematology/oncology and transfusion medicine. She comes to CBS from Westchester Medical Center, where she was director of Transfusion Medicine Services from 2007 until 2010. At the same time, she was medical director of Hud-son Valley Blood Services for New York Blood Center (NYBC). From 2000 to 2005, she directed the Comprehensive Sickle Cell Center at St. Luke’s-Roosevelt Hospital Center in New York City, and for seven years before that, she directed the Pediatric Sickle Cell Program at Mt. Sinai Medical Center, also in New York City. She also has held a number of academic positions at univer-sities in New York City. Dr. Sutton replaces Ronald Walsh, MD, who has been medical director at CBS since last summer. He is leaving to pursue an academic appointment, the blood center said in a press release. Dr. Sutton’s clinical research has focused on sickle cell disease, and she received an award in 2002 from the Sickle Cell Trust Foundation for her outstanding contributions to clinical research. In 2005, The Net-work Journal named her one of its “25 Most Influential Black Women in Business.” Dr. Sutton received her bachelor’s degree in chemistry from Dillard University in New Orleans, La., and her medical degree from Meharry Medical College in Nashville, Tenn. Her post-graduate training in-cluded five fellowships, including one in pediatric hematology at Children’s Hospital in Philadelphia, another in pediatric oncology at Columbia Presbyterian Medical Center in New York City, and a third in transfusion medicine at NYBC.

Denden Alcantara. Ms. Alcantara has been working in transfusion medicine for more than 10 years. She is a specialist in immunohematology and blood banking. She comes to CBS from NYBC, where she was the senior immunohematologist of the Laboratory of Immunohematology and Genomics. Before that, she worked in the blood bank of Memorial Sloan-Kettering Cancer Center in New York City as the chief blood bank technologist. While she was at NYBC, Ms. Alcantara worked with Marion Reid, MD, and Christine Lomas-Francis. Under their guidance, she wrote a research paper on the JAL (Rh48)

antigen that earned her the 2008 AABB Fenwal SBB Scholarship Award and the 2009 Gulf Coast Re-gional Blood Center SBB Scholarship Award. Ms. Alcantara completed the Specialist in Blood Banking program at the Gulf Coast Regional Blood Center in Houston, Texas. She also has a master’s degree in forensic examination from Touro College, in New York City.



CBS Announces New Hires (continued from page 3) Pascal George. As CBS’ senior financial adviser, Mr. George will oversee the blood center’s financial department. Mr. George has been working in the hospital and biolog-ics industries for more than 20 years. He previously worked in a variety of positions at NYBC, such as executive director of Clinical Services and vice president of Blood and Medical Operations. Mr. George earned his bachelor’s degree in math and science from College Militarie de St-Cyr-l’Ecole, France; a graduate degree in management from the ESSEC International Business School; and a master’s of business administration in healthcare administration from Wharton Business School at the University of Pennsylvania. Review of Studies Finds that Noneconomic Caps Reduce Liability Costs A review of studies shows that caps on noneconomic damages in medical malpractice lawsuits help re-duce the cost of medical liability insurance, and they also appear to lower rates of defensive medicine. Those are a few of the assertions of an article that appeared in a recent issue of the New England Journal of Medicine, based on a review of studies published through 2009 in medical, economics and law jour-nals, as well as government and philanthropic foundation reports. The article was authored by Allen Kachalia, MD, JD, and Michelle M. Mello, JD, PhD, both attached to Harvard University-related institu-tions. The review looked at studies of eight of the most widely adopted state reforms: caps on damages; pretrial screening panels; certificate of merit (COM) requirements (affidavit that a qualified medical expert be-lieves there is cause for a suit); limits on attorneys’ fees; joint-and-several liability (JSL) reform (limits financial liability of each defendant to percentage of fault); collateral-source rule reform (bars rule prohib-iting deduction of compensation amounts from health insurance from a defendants’ liability amount), periodic payment (rather than lump sum payments); and statutes of limitations and repose (amount of time that a patent has to file a claim). The review found that traditional tort reforms have mostly focused on liability costs rather than improving patient care and that with a few exceptions, including caps on noneconomic damages, “traditional tort reforms have not proved to provide many improvements in liability metrics.” For all traditional reforms, “the evidence on care-related metrics is fairly sparse overall.” Caps on noneconomic damages, which limit the amounts that juries may award for pain and suffering, constitute the main exception, the authors say. “Studies have nearly uniformly found that caps are an ef-fective means of reducing the size of indemnity payments.” Based on “methodologically strong studies using recent data,” the review found that “caps modestly con-strain the growth of insurance premiums over time,” though their effect on claims frequency is still a question. The authors say that statutes of limitation and repose seem to lower premiums, “but the mechanism of effect is unclear, because they are not significantly associated with lower frequency of claims, indemnity costs, or overhead expenses.”



Med-Mal Reforms (continued from page 4) Other reforms fare poorly. “Studies of pretrial screening panels, COM requirements, limits on attorneys’ fees, JSL reform, collateral-source rule reform, and periodic payment generally have not identified sig-nificant effects on claims frequency, indemnity costs, or insurance premiums,” the authors say. There is some evidence that screening panels, COM requirements, and fee limits result in increased over-head costs because they mean more procedural requirements and more legal complexity – “but this evidence is not conclusive.” There is little or no available evidence concerning the effects of the other most traditional reforms on defensive medicine. However, the effects of caps on damages, JSL reform, and collateral-source rule re-form on defensive medicine have been well studied and the conclusions sound. “Caps are associated with lower rates of defensive medicine, whereas all studies of collateral-source rule reform have found no ef-fect, and findings concerning JSL reform have been mixed.” There is also some evidence that caps on damages modestly increase the supply of physicians in a state, although study findings have been mixed. And there is “moderately strong evidence” that limits on attor-neys’ fees, collateral-source rule reform, and periodic payment do not significantly affect physician supply. Citation: Kachalia A and Mello MM. New directions in medical liability reform. NEJM 2011;364:1564-72. [Epub ahead of print] Study: Hemoglobin Deferrals Have a ‘Strong Effect’ on Donors Australian blood donors who are deferred because of low hemoglobin (Hb) levels are significantly less likely to attempt to donate in the future, according to a study published in last month’s Transfusion. How-ever, the study found that donors with strong donation habits were less impacted by a temporary deferral than first-time donors or repeat donors who had not donated in the year before their deferral. The study was conducted by Tessa Hillgrove, PhD, and three of her colleagues at the Australian Red Cross Blood Service (ARCBS) and the University of Adelaide, in South Australia. They write that identi-fying the factors associated with donors’ return could guide blood centers as they develop more targeted, more effective recruitment efforts. This study complements previous research on the impact of temporary deferrals on donors. Low Hb is a particularly common reason for such deferrals: in Australia, it results in the deferral of 5 percent of donors each year; in the US, six blood centers recently found that 10 percent of their donors were deferred for low Hb (see story on page 7). In Australia, women must have more than 120 grams/liter (g/l) of Hb in order to donate, as determined by a capillary finger-prick test; men must have more than 130 g/l. People whose levels are below those limits are deferred for six months. Methodology. This retrospective cohort study analyzed ARCBS’ donation records and demographic in-formation for everyone who tried to donate whole blood in October and November of 2004 in the states of New South Wales and South Australia. Dr. Hillgrove and her colleagues assessed whether and when people who had been deferred (i.e., the “deferral group”) came back to try to donate again, and how their return rate and time to return compared to those measures for people who had not been deferred (i.e., the “comparison group”).



Hemoglobin Deferrals (continued from page 5) The researchers called the donation attempt during the study period the “reference donation” for each person. They looked at whether each donor had tried to donate blood in the 12 months before his or her reference donation; they also determined whether, when, and how many times each donor attempted to donate blood in the three years after they were eligible to return. (Whole blood donors in Australia are eligible to donate every 10 weeks or 70 days, although ARCBS does not invite them to return for 12 weeks or 84 days after each donation.) Findings. The study included 1,011 people in the deferral group and 68,675 in the comparison group. The researchers found significant differences between the two groups in terms of the likelihood of return, the time to return, the frequency of donations, and the likelihood of dropping out of donation later. Of donors who were deferred for low Hb levels, 58.5 percent returned within the three-year follow-up period, compared to 87.4 percent of the comparison group. The difference was more pronounced among first-time donors: 20.9 percent of deferred first-time donors returned within three years, compared to 69.9 percent of those who had not been deferred. Among repeat donors, 64.0 percent of the deferred group returned, while 91.0 percent of the comparison group did. When the researchers considered deferred donors who later returned to try to donate again (the research-ers call each attempt an “attendance”), they found that only the donors’ attendance frequency was a significant predictor of their return after a deferral. Repeat donors who had not donated in the year before their reference donation had a similar likelihood of returning after a deferral as donors who were deferred in their first attempt to donate. The researchers also found that deferred donors were slower to return than those who were not deferred. In the deferred group, the median time to return was 13.2 weeks after the donors became eligible again; in the comparison group, the median time to return was 2.7 weeks. Deferred donors, in addition, later gave significantly fewer donations than those in the comparison group. In the first year after they were eligible to return, deferred donors gave a mean of 1.1 donations, while those in the comparison group gave a mean of 2.3. In year two, those numbers were 0.9 versus 1.8 dona-tions; in year three, they were 0.8 versus 1.7. Those numbers also represent a substantial drop from the mean number (2.4) of times deferred donors gave blood in the year before their deferral. Finally, the researchers found that deferred donors were more likely to discontinue donating in the second or third year after their deferral, even if they returned in the first year after it. The authors point out that their results differ from those of previous studies in numerous ways. For exam-ple, this study found that deferral had a strong impact on return rates not just for first-time donors, but also for repeat donors. On the other hand, they say it builds on existing literature by “demonstrate[ing] a strong relationship between donation patterns and resilience to a temporary deferral.” This is particularly clear, they say, in the smaller impact of temporary deferrals on regular donors than on first-time donors or repeat donors who had gotten out of the donation habit. The authors also suggest that if a donor “can be encouraged to return at least once within a year of being eligible to return” after a deferral, “the detrimental effect of deferral on return and donation frequency can be minimized.” They conclude that first-time donors who are deferred should be targeted by recruiting efforts, as should repeat donors who were returning after a break. Citation. Hillgrove T, et al. The impact of temporary deferral due to low hemoglobin: future return, time to return, and frequency of subsequent donation. Transfusion. 2011 Mar;51(3):539-47.


Many Frequent Donors Are Iron Depleted, Study Finds Six US blood centers found that nearly half of their donors had iron-deficient erythropoiesis (IDE), and nearly one-seventh had absent iron stores (AIS) – meaning that a large proportion of donors have iron depletion. The six centers were participants of the Retrovirus Epidemiology Donor Study-II (REDS-II) group’s Do-nor Iron Status Evaluation (RISE) study. The RISE study was conducted between December 2007 and December 2009 to assess the effects of blood donation intensity on iron and hemoglobin (Hb) status. The results of the study were published in the March issue of Transfusion. The study was led by Richard G. Cable, MD, of the American Red Cross Blood Services’ New England Region. At America’s Blood Centers’ annual meeting last month, Dr. Cable spoke about the study results and answered questions about its implications for donors’ health. He said that a little deficiency is not necessarily bad for people – but he noted that there do seem to be health problems with more significant iron depletion. In the Transfusion article, Dr. Cable and his colleagues on the REDS-II team reported that, among 2,425 red blood cell donors, they found that 15 percent had AIS and 41.7 percent had IDE. Those percentages were 16.4 and 48.7, respectively, for frequent donors (men who had given three or more whole blood donations in the past year, and women who had given two or more). Of women who were frequent do-nors, 27.1 percent had AIS and 66.1 percent had IDE. The researchers also were able to determine an association between AIS/IDE and female donors and do-nors with lower donor weight. They point out that these factors could be used to alter standards for donation frequency, particularly as related to donor sex and size. They also found that donors who took iron supplements had a significantly lower prevalence of AIS than donors who did not take the supplements. However, the magnitude of the effect was small: 14.9 percent of donors who took iron supplements had AIS, compared to 15.2 percent of those who did not. They con-clude that a trial of iron supplementation is warranted. The authors conclude that the health of blood donors “requires significant attention,” particularly in terms of the importance of iron depletion and the ability of current donation standards to prevent it. Indeed, Gary M. Brittenham, in an accompanying editorial, notes that the Food and Drug Administration is cur-rently considering whether it should change the recommended interval between donations, and whether it should adjust the levels of Hb or hematocrit that are used as cut-off points for deferrals. Citations: Cable RG, et al. Iron deficiency in blood donors: analysis of enrollment data from the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2011 Mar;51(3):511-22. Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61.

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



On the Inevitability of Healthcare Reform “When the White House celebrated the passage of Affordable Care Act (ACA) on March 23, oppo-nents hoped that this first anniversary of the law would also be its last. That’s unlikely. Earlier this year the Senate swiftly rejected a House bill that would have repealed the law. And although Re-publican governors continue to bash Obamacare, the majority has joined their Democratic counterparts in accepting federal funds to implement the central feature of the ACA: the exchanges or marketplaces that beginning in 2014 will provide health insurance for some 30 million uninsured Americans. “In the state legislatures the most substantive alternatives to the federal law have been watered down. Missouri and South Dakota passed non-binding resolutions opposing elements of the ACA. Tennessee approved a bill saying that individuals can’t be required to purchase insurance. “Neither time nor public opinion is on the side of the Republicans. While the ACA has never been wildly popular except in the imagination of the White House, a majority of Americans oppose re-peal of the law now that it is on the books. An average of seven national polls through April 2nd compiled by RealClearPolitics shows 52.4 percent of respondents opposed to repeal and 39.2 per-cent in favor. “Nor has the administration stood still in building support at the state level. As Secretary of Health and Human Services Kathleen Sebelius has happily observed, 48 states have accepted at least $1 million each from the federal government to help plan for the insurance exchanges. … In February she announced grants totaling $241 million to six ‘early innovator’ states and a multi-state consor-tium led by the University of Massachusetts Medical School for development of the technology infrastructure needed to operate the exchanges. “This understandably worries Republicans opposed to the ACA. Gov. Mitch Daniels (R) of Indiana has warned that the federal government is now so much in the driver’s seat on health care that it only needs to ‘play good defense’ to prevail. Speaking to the 2011 Conservative Political Action Conference earlier this year, Daniels predicted: ‘The healthcare travesty now on the books will engulf private markets and produce a single-payer system or its equivalent, and it won’t take long to happen.’ “Conservatives differ over the strategies and tactics they should use to slow the federal leviathan. Writing in the conservative magazine National Review, Michael F. Cannon (no relation) of the Cato Institute … declared that if the exchanges go into effect as scheduled in 2014, millions of newly insured Americans will have vested interests in preserving the federal law, as will the insur-ance companies who write their policies.”

– Excerpted from a column by Lou Cannon in StateNet Capitol Journal, 4/18/11

Octagam (continued from page 1) Octagam Immune Globulin Intravenous (Human) 5% first received approval from the US Food and Drug Administration in May 2004 for the treatment of primary immunodeficiency diseases after being on the market in Europe for 10 years. Octagam is currently registered in about 60 countries, including the US and the EU. Octagam competes with other immunoglobulin products from Baxter, CSL, and Grifols. (Sources: Reuters, 4/14/11; Financial Post, 4/15/11)


RESEARCH IN BRIEF A new study shows that implementing clinical decision support alerts as part of a computerized physician order entry system improves decision making when considering transfusions of red blood cell (RBCs) for child patients. Researchers found that the reminders prevented 460 unnecessary transfu-sions, for a total cost savings of $165,000 over one year. As part of the study, published online in the journal Pediatrics, researchers from the Stanford University School of Medicine and Lucile Packard Children’s Hospital, both in Palo Alto, Calif., built automated alerts into the hospital’s electronic health record system to determine if they would help physicians adhere to guidelines for ordering RBC transfu-sions. The system alerted physicians ordering transfusions whenever a patient did not meet the clinical criteria for receiving the procedure. “We demonstrated that having clinical decision support baked into the fiber of ordering practices can have a significant, durable impact on the delivery of clinical care,” said David Cornfield, MD, medical director of critical care at Packard Children’s Hospital and the study’s senior author. Eloa Adams, MD, a pediatric critical care physician and another author of the study, said the alerts are an easy, inexpensive way to implement change in clinical practice, particularly when guide-lines change. (Source: ModernHealthcare.com, 4/18/11) Citation: Adams ES, et al. Computerized physician order entry with decision support decreases blood transfusions in children. Pediatrics. 2011 Apr 18. [Epub ahead of print] BRIEFLY NOTED An Italian company plans to release a line of unisex perfumes that is based on the four blood groups. “Our four fragrances, A, B, AB, and O, retrace the evolution of manhood through time and its record of information, history and mutation, so well kept in the vital flushing of blood,” says the head-scratch-inducing sales pitch on the company’s website. “Blood Concept is a mystic ritual with no flowers to be found: deep as primeval Africa in O, aromatic as the scent of familiar land in A, bold as unpredictable itineraries in B, [and] sharp and freezing as a metropolitan skyline in AB.” The Blood Concept perfumes all feature metallic notes and celebrate “the vivid and fascinating liquid that flows in our veins,” according to the website. “A” is aro-matic and carries a blend of green garden, tomato leaves, basil, and star anise. The “B” blend is on the woodier side and includes notes of red apple, black cherry, and pepper, while “AB” has a mineral structure infused with hints of aluminum, slate, pebble, and cedar wood at its base. Lastly, “O” is composed of thyme, raspberry, cyperus esculentus, rose hips, birch, leather, and cedar wood. Each perfume is stored in a dropper bottle and contains zero floral notes. But it also contains no blood. According to the company’s Facebook page, the line will be released this Sep-tember. Pricing and information on where the line will be sold have yet to be announced. (Sources:

BSNews.com, 4/13/11; BloodConcept.com)

urg, Md., April 28-29, 2011. Issue summaries are available for the three ain topics to be discussed.

advice from the committee on whether scientific data support the concept that testing source


C The Food and Drug Administration’s Blood Products Advisory Committee has released materials for its meeting in Gaithersbm

Topic I: Testing Source Plasma for Hepatitis B Virus by Nucleic Acid Testing. FDA seeks

http://www.facebook.com/pages/Blood-Concept/205385622820437?sk=wall


BRIEFLY NOTED (continued from page 9)

plasma for hepatitis B virus DNA by nucleic acid testing increases the margin of safety of plasma derivatives and whether such detection in donors adds to public health.

Topic II: Current Considerations on Plasma for Further Manufacturing Obtained from Whole

Blood Donors. FDA seeks advice from the committee on appropriate manufacturing standards for plasma products collected from whole blood donors to make plasma-derived products.

Topic III: Blood Donor Written Statement of Understanding. FDA seeks advice from the com-

mittee on the appropriate elements of a written statement of understanding for whole blood donors, and the best methods to present this information to the donor.

A full agenda, committee roster, and issue summaries are available on the FDA website at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm247665.htm. Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS) has been awarded $50 mil-lion to expand the use of solar panels on its buildings’ rooftops and carports. The project is expected to significantly reduce electrical consumption and dependency on fossil fuels. VAGLAHS is the largest healthcare system within the Department of Veterans Affairs, serving 1.4 million veterans. It consists of

three ambulatory care centers, a tertiary care facility, and 10 commu-nity-based outpatient clinics. “We look forward to reducing our electrical consumption by implementing clean solar projects. Our veterans are reacting positively to the solar panel projects, and we love hearing that,” said VAGLAHS Director Donna Beiter. The pan-els should save the VA some $1.7 million annually. In addition, considerable rebate incentives will be provided by the utility compa-nies. The project involves buildings at the West Los Angeles Medical Center (which already has several panels), Sepulveda Ambulatory Care Center, and the Los Angeles Ambulatory Care Center. Initially VAGLAHS received $31 million for solar panels, but that funding has increased to $50 million. “The current federal mandate is to re-

duce energy intensity by 30 percent by 2015 and increase the use of clean renewable energy. We feel extremely confident that we will

reach that mandate,” said Robert Benkeser, VAGLAHS chief of Facilities Management. (Source: VAGLAHS, press release, 4/18/11)

An example of a rooftop solar array.

REGULATORY NEWS The Food and Drug Administration has issued a draft guidance on required labeling changes when new safety information becomes available after a drug or biological product is approved. Titled, “Safety Labeling Changes – Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cos-metic Act,” the draft guidance implements new provisions that the Food and Drug Administration Amendments Act of 2007 (FDAAA) added to the Federal Food, Drug, and Cosmetic Act. In the past, FDA requested that manufacturers make labeling changes to address serious risks posed by products that had already been approved. In most cases, companies negotiated appropriate language with FDA staff to address the concerns, and then submitted a supplement or amended supplement to their application to obtain approval of the change. Negotiations were often protracted, and FDA had few tools available at its



REGULATORY NEWS (continued from page 10) disposal to end negotiations and require changes. Congress, recognizing the limitations of FDA’s author-ity in this area, passed FDAAA, which gave FDA new authority to require safety labeling changes in certain circumstances. The draft guidance provides information on the implementation of the new provi-sions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation, how FDA plans to determine what constitutes new safety information, the pro-cedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes. Electronic comments can be submitted by 7/12/11 to http://www.regulations.gov. More information is available by contacting Kristen Everett at (301) 796-5400, or Stephen Ripley at (301) 827-6210. FABC NEWS Benefit Concert Will Help FABC Improve Blood Services in Haiti The Foundation for America’s Blood Centers has a Grammy-nominated pop rock group on its side: Plain White T’s. A portion of the proceeds from the group’s May 13 Hearts for Haiti concert in Orlando, Fla., will go to FABC and the University of Central Florida Foundation’s Emerging Technologies Lab, a non-profit organization that supports emerging technologies in third-world countries. Plain White T’s formed in 1997 in Chicago. Its most well-known hit is the 2007 song “Hey There Delilah,” which was nominated for a Grammy award in 2008. The band is currently touring to support its new album, “Wonders of the Younger.” The band reports on its website that it has also supported other charitable efforts, including the “Download to Donate” pro-gram, which benefits people in Japan as the country recovers from the earthquake and tsunami there last month. New FABC board member Sean Hayes is one of the organiz-ers of the event in Orlando, which will include a silent auction as well as the concert. He attributes his commitment to FABC to the fact that his daughter, Brooke, developed a rare blood disorder when she was six months old. “It was three transfusions that saved her life after all else failed,” Mr. Hayes said. “The blood center worked hard to find a match to her antibodies, and we are very grateful for their efforts.” FABC will use the funds it receives to support efforts to re-build a blood collection center in Haiti, as well as the strengthening of the country’s hemovigilance pro-gram. Haiti’s National Center for Transfusions, in Port au Prince, was destroyed by the earthquake that hit Haiti in January 2010. The building that housed the headquarters for the country’s National Blood Safety Program (NBSP) also was destroyed. The loss of both facilities has hampered NBSP’s activities –


http://www.regulations.gov/


Benefit Concert (continued from page 11) which focus on establishing standards for safe blood transfusion, increasing voluntary blood donation, and facilitating patients’ access to safe blood – according to a report issued by the Pan American Health Organization (PAHO) this January. Haiti’s Ministry of Health and Population is now focusing on rebuilding the Haitian health system, in-cluding reconstructing damaged or destroyed facilities. One pilot program is concentrating on ensuring a safe and reliable blood supply in the country, and it is particularly focusing on being able to provide ade-quate and safe blood to mothers during childbirth, as inadequate supply is tied to their mortality rates. The pilot program is currently raising money to cover the cost of 22 laptop computers and 22 printers, which will be about $42,000, according to the Facebook page for the benefit concert. The program’s one-year costs are estimated to be $329,000. (Sources: http://new.paho.org/disasters, accessed 4/21/11; Face-book, accessed 4/20/11; http://plainwhitets.ning.com, accessed 4/21/11) MEMBER NEWS Suncoast Hosts South Korean Medical Technologist Last fall, when America’s Blood Centers’ CEO Jim MacPherson invited ABC mem-bers to host a fellow from South Korea, Suncoast Communities Blood Bank jumped at the opportunity. The result was a three-month visit from Kiho Nam to the blood center in Sarasota, Fla. Mr. Nam, a medical technologist who lives in Seoul, stayed in Sarasota from January until the end of March, using the time to study blood donation in the US by observing blood bank recruitment activities at Suncoast and reading American blood banking journals, books, and websites. Mr. Nam’s expenses were covered by a fellowship from the South Korean government. According to an article about Mr. Nam in Suncoast’s employee newsletter, he said that blood in Korea is collected by a government agency, and that it is often difficult to maintain an adequate supply. He hoped to learn new ways to motivate people to give blood during his time in the US. Diana Berry, Suncoast’s director of Quality Assurance, said Mr. Nam was a diligent student and spent about 25 hours a week at Suncoast, studying the blood center’s strategies for increasing blood donations and ensuring blood safety. The blood center found a place for him to live and provided him with a bicycle, which he used to com-mute between his condominium and the blood center and to explore the area, Ms. Berry said. She added that Mr. Nam found nearby Anna Maria Island “one of the most beautiful places he had ever seen.” Mr. Nam earned a degree in Medical Laboratory Science from Korea University, and he works for the Korean Centers for Disease Control and Prevention as a quarantine officer at the Incheon International Airport in Seoul. He will write a 100-page report on what he learned in the US, and he will share the report with the proper department in Korea’s Department of Health and Human Services, he said in an e-mail to Mr. MacPherson.


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

Total ABC Red Cell Inventory

Percent of Regional Inventory at

2 Days Supply or Less, April 20, 2011

2% 4% 2%11% 6% 14%

72% 67% 67%

71% 73%66%

23%21% 28%

15% 20% 19%1%

9%1%3%3%4%

16-Mar 23-Mar 30-Mar 6-Apr 13-Apr 20-Apr

Red (1 day or less)Yellow (2 days)Green (3 days or more)No Report

19%

32%23%

28%

1%

3%

0%

1%

0%0%

Total East Midwest South West

Daily Updates are available at: www.AmericasBlood.org

MEMBER NEWS (continued from page 12) Mr. Nam told Mr. MacPherson that Ms. Berry, Suncoast CEO Kevin Lindberg, and other employees at Suncoast helped him get used to life in Sarasota, and that Ms. Berry was particularly helpful in his stud-ies. Ms. Berry, in turn, said that employees at Suncoast enjoyed getting to know Mr. Nam. His visit was a real “win-win situation for all,” she said.

*** Héma-Québec is celebrating Canada’s National Organ and Tissue Donor Week (April 17-24) in a number of ways. For the “Give Your Very Best” awareness campaign, Héma-Québec has joined forces with the Department of Health and Social Services (Ministère de la Santé et des Services sociaux), The Québec Health Insur-ance Board (Régie de l’assurance maladie du Québec), Québec-Transplant, and the Québec Chamber of Notaries (Chambre des notaires du Québec) to promote the importance of donating organs and tissues. The partners are also unveiling a new tissue and organ donation site, www.signezdon.gouv.qc.ca, which provides information to select the best way to make a person’s wishes known about donating tissues or organs. The month-long campaign will also provide support for the Register of Consents to Donate Or gans and Tissues (Registre des consentements au don d’organes et de tissues), which started on Feb. 28.


http://www.americasblood.org/

http://www.signezdon.gouv.qc.ca/


MEMBER NEWS (continued from page 13) The blood center is also conducting organ and tissue donation awareness activities for blood donors who attend drives this week. Members of the blood center’s human tissue team will present at various hospi-tals a new communication tool intended for hospital personnel who deal with the families of potential donors. In addition to its role as a supplier of blood products for Québec, Héma-Québec also supplies human tissues intended for transplants (including skin grafts, heart valves, and muscular-skeletal tissues such as tendons and bones) and makes them available to hospitals in Québec. Moreover, Héma-Québec also collects eyeballs to be used in cornea transplants. (Source: Héma-Québec press release, 4/17/11) MEETINGS June 21-23 2011 State Healthcare IT Connect Summit, Dulles, Va. Co-sponsored by the Council of Accountable Care Physician Practices (CAPP). The

summit’s goal is to “support and engage in a high-level dialogue between public and pri-vate stakeholders regarding the IT road map that will promote the development of ACOs as part of healthcare delivery system reform,” according to a statement from CAPP Ex-ecutive Director Nancy Taylor. Speakers will include representatives from a number of branches of the Department of Health and Human Services, executives at a number of health insurance and healthcare companies, state health officials from across the country, and other subject matter experts. Continuing education credits will be available. More de-tails are available at http://statehealthcareitconnectsummit.eventbrite.com/.

Contact: Toyomi Igus, Communications Director at CAPP, or Victoria Smith, Communi-

cations Director, Healthcare IT Connect. E-mail: [email protected] or [email protected].

POSITIONS AVAILABLE:

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

President and CEO. Coffee Memorial Blood Center in Amarillo, Texas, is seeking a proven leader for the position of president and CEO. Five years of progressive responsi-bilities in blood center management required, or a minimum of ten years of progressive management experi-ence in other industries, preferably healthcare-related. Significant and successful experience in blood center executive management desired. Must possess education and experience to enable management of a highly regulated organization; ability to lead development, implementation, measurement, and oversight of operational and financial plans. Essential skills and abilities include excellent written and verbal communications, familiarity with accounting practices, sound understanding of personnel management and problem resolution, and drive to represent the blood center at local, regional, and national levels. For more

information please visit Coffee Memorial Blood Center’s website at www.thegiftoflife.org/jobs.htm. Curriculum vitae, references, and requests for additional information may be submitted to Kathy Mitchell, SPHR by fax (806) 358-2982 or e-mail ([email protected]). EOE

Medical Technologist. The American Red Cross seeks a Medical Technologist for Blood Bank Reagent Manufac-turing to join our team in Gaithersburg, Md., to assist in the testing and production of blood bank diagnostic reagents. The Medical Technologist performs blood bank and chem-istry tests on raw material and in-process product and interprets results at various stages; participates in the per-


http://accountablecarefacts.us1.list-manage.com/track/click?u=1561ddd41db80a3c745e38eb2&id=4adb664088&e=9aa0996a3d






POSITIONS (continued from page 14)

formance of validation protocols and development of standard operating procedures; performs necessary proc-esses to purify plasma; and prepares bulk material and may participate in filtration and filling operations. This position contributes to new product development and maintains records in compliance with American Red Cross and FDA guidelines. Qualified candidates possess a bachelor’s de-gree in Medical Technology or biological science with three years’ blood banking experience. Experience in diagnostic reagent manufacturing or an immunohematol-ogy reference laboratory preferred. To apply, visit www.americanredcross.apply2jobs.com and search for requisition number NHQ10778. The American Red Cross is an Equal Opportunity/Affirmative Action Employer.

Blood Bank Specialist – Reference Laboratory. Make a difference in the lives of others working in sunny San Diego with mountains, beaches and mild temperatures year round! San Diego Blood Bank (SDBB) is a not-for-profit community blood center that provides blood services for hospitals in Southern California. The reference laboratory provides immunohematology support to hospitals for a wide variety of cases. Perform special testing in the identi-fication of red cell antibodies, platelet studies, red cell antigens, and molecular antigen testing. Looking for quali-fied candidates who enjoy a challenge and the sense of reward when a complicated case is solved. CLS or eligible; ASCP MT; SBB preferred. SDBB offers competitive wages, a generous paid time off program, 100 percent employee paid health benefits, pension plan, and 403(b). SDBB offers an ideal location to start a career, opportunity to take on leadership roles, and ability to grow within the organization. [email protected] or (619) 400-8320. EEO/AA /M/F/V/D

Chief Compliance Officer. The American Red Cross is seeking a Chief Compliance Officer to join our team in Washington, DC. This position manages the coordination and preparation of internal and external audits and compli-ance in accordance with regulatory standards; conducts long-range studies to evaluate and investigate compliance risks; and provides compliance assessment to operations, quality and regulatory affairs, and executive management on compliance performance and improvement. Addition-ally, the Chief Compliance Officer manages the Quality and Compliance Plan, maintains the SOP-ARCBS Com-pliance Program Policy, and co-chairs the Quality and Compliance Oversight Committee (QCOC). Qualified candidates possess a master’s degree/relevant experience and at least 15 years’ work experience. Ideal candidates possess at least 10 years’ experience in a biomedi-cal/biotechnology, pharmaceutical and/or healthcare organization, and have demonstrated at least 10 years of leadership/management experience. To apply, visit www.americanredcross.apply2jobs.com and search for requisition number NHQ9062. EOE, M/F/D/V

Donor Services Supervisor (#516). Inland Northwest Blood Center, located in the beautiful Pacific Northwest, is

seeking a full-time Donor Services Supervisor to super-vise/direct/evaluate performance of personnel, utilizing effective/efficient application of available resources to meet/exceed collection goals. Manage the assignment of staff schedules providing for optimal donor care/staff well-being; three year’s work experience in a related medical environment, preferably in blood banking; voca-tional/technical certification in a healthcare-related field, or equivalent combination of one to three years educa-tion/training in a related field preferred; two years’ training and supervisory experience preferred; in the absence of nursing licensure, Health Care Assistant certifica-tion/ability to obtain; ability to lift up to 25 pounds occasionally. Complete position description available upon request (800) 423-0151 x 4247. Competitive compensa-tion/benefits package; applicants must send/fax a completed INBC application to Attn: Human Resources, INBC, 210 W. Cataldo Ave., Spokane WA 99201; fax: (509) 232-4530; position open until filled. Applications are available on our website at www.inbcsaves.org. EEO/AA

Scientific Affairs Director. Leading blood safety organi-zation Novartis Diagnostics is looking for a highly motivated well regarded Scientific Affairs Director based in Asia Pacific with strong research and collaboration skills, to support the company’s fast growing business in the region. The individual will have worked in the blood banking industry in a leadership position and be recognized by his/her peers through their significant contribution to blood safety, illustrated by high quality publications. A strong advocate of nucleic acid testing, the individual will be current in scientific and technological developments and trends in the industry with at least 15 years of experience. The successful candidate will: define strategies for evalua-tions and reviews of products and systems; act as company spokesperson and educator through presentations and stakeholder visits; develop research protocols, clinical trials, and regulatory testing strategies; determine whether user activities are investigator or company sponsored; work as key contact for users in publishing data and presenting data at regional/international meetings; and support mar-keting and sales efforts. Interested parties should send resumes in confidence to [email protected], Director Human Resources Asia.

Vice President of Administrative Services (Full Time). Reporting to the CEO of the Blood Bank of Delmarva, this position collaborates with executive management staff to develop, implement, and monitor strategic initiatives that improve organizational performance, culture, and image, while maintaining overall financial health. The VP of Administrative Services is the lead executive responsible for developing and leading key functions that support technical blood operations. This role heavily interfaces with the VP of Technical Services to ensure integration and coordination of functions of Marketing and Community Relations, Facilities Management, Purchasing, Finance, Information Technology, Donor Scheduling, and Member Services.




Position requires a bachelor’s degree in Marketing, Busi-ness, Healthcare Administration, Finance, or a related field. Graduate degree preferred. In addition, at least ten years of relevant professional experience in operations, administra-tion, or general management is necessary. Interested applicants may apply through www.Careerbuilder.com.

Executive Director, Quality, Compliance and Training (Full Time). Blood Bank of Delmarva seeks individual to be a top leader in the organization responsible for driving a culture that embraces quality, quality systems, regulatory compliance, and continuous process improvement. This position provides leadership for activities associated with Blood Bank of Delmarva’s Quality Management System; represents the organization at a senior level to external regulatory bodies such as the FDA; drives a strategic ap-proach to lead and support process improvement initiatives; develops and maintains an organization-wide system to ensure training and competency activities are compliant, high quality, and timely. Successful candidate should possess a minimum of a bachelor’s degree in Nursing, Medical Technology, Healthcare, Organizational Man-agement, or related field. Master’s degree or MBA along with ASQ or Six Sigma certification desirable. The ideal candidate will possess ten years of relevant leadership experience with a demonstrated ability to develop and execute short and long-term strategic objectives; experi-ence creating and managing successful business strategies in a highly regulated environment; and proven Lean or Process Improvement experience. Interested applicants may apply through www.Careerbuilder.com.

Sales Specialist. The Puget Sound Blood Center is seeking a Sales Specialist to represent the organization’s Medical and Laboratory Service departments. The primary objec-tive of this position is to successfully uncover and secure new business within the biotechnology, contract research, and reference laboratory industries. This position requires a bachelor’s degree in a life sciences or business field, an advanced degree is desired. Minimum two to three years of experience in research or specialty clinical laboratory required (molecular, genomics, immunology, etc.), as well as one to three years of experience selling testing services or medical devices into specialty or research laboratories. Excellent communication skills and solid computer skills are essential to this role. Overnight travel ability of about 50 percent time is required for this position. To apply: send resume/cover letter to: [email protected] or fax: (866) 286-8495. Please reference #6474.

Account Executive (2 positions). The Puget Sound Blood Center has an exciting opportunity for experienced account executives who can enhance our customer-centric culture and develop new opportunities for our organization. These positions will be responsible for multiple business line sales goals within their territory and foster solid working relationships with our customers. These positions require a bachelor’s degree and an advanced degree is desired. Medical technology or healthcare background is highly

preferred with a minimum of three successful years of medical device or pharmaceutical sales/marketing experi-ence. Professional sales experience within transfusion and/or laboratory medicine settings strongly preferred, in addition to solid overall business/financial acumen. Excel-lent communication skills and solid computer skills are essential. These positions will require extensive day travel and occasional overnight travel. To apply: send re-sume/cover letter to: [email protected] or fax: (866) 286-8495. Please reference #6472.

Assistant Director, Technical Services. Community Blood Center of the Ozarks, a nonprofit organization in Springfield, Mo., supplies blood products to 37 hospitals in our service area. This position will assist the senior director with management of the Laboratory and Distribution de-partments. Other duties to include performing bench tasks in Product Counting Lab, Immunohematology Lab, and Labeling/Quarantine and Distribution; review of laboratory and distribution documents; SOP review and development; Quality Assurance Information Reports and corrective actions; donor notification and counseling; assessing per-sonnel competency, proficiency, and adherence to blood center guidelines, policies, and procedures; conduct-ing/assisting in staff performance evaluations and assessments; participating in recruitment and selection of employees; conducting or providing staff training; assuring adequate coverage for Immunohematology and Distribu-tion departments. Medical Technologist certification required. Minimum of two years of technical and manage-rial experience in the field with a specialty in blood banking preferred. To apply, e-mail resume to [email protected] or fax to (417) 890-0841.

Medical Technologist. United Blood Services in Lubbock, Texas, is seeking an Immunohematology Reference Labo-ratory Medical Technologist to perform and interpret serological procedures on specimens submitted for problem resolution. This professional will also perform routine component QC, donor testing, and component production, as well as therapeutic apheresis procedures. Minimum qualifications: bachelor’s degree in a chemical, physical, biological, medical technology, or clinical laboratory sci-ence, and certification as a medical technologist. Preferred: Three years’ experience in a clinical laboratory setting or SBB. See our website, www.unitedbloodservices.org, for details and an application. Submit resume and application to UBS-HR, 2523 48th Street, Lubbock, TX 79413, fax (806) 771-5024, or e-mail [email protected] by Friday, April 29. Employee drug testing required.

Cell Therapy Program Manager. The Puget Sound Blood Center is seeking an experienced leader to manage operations of our Cell Therapy Program and oversee the development and coordination of protocols and procedures of the lab. The Program Manager is responsible for quality control, technical audits, and developing strategies for implementing methodology, products, and services. This



POSITIONS (continued from page 16) opportunity involves significant interaction with the public and other medical organizations regarding the Cell Therapy Program and supervising both direct and indirect reports. The requirements include: baccalaureate degree in medical technology or equivalent certification; minimum two years’ experience in cellular therapy or related field; SBB pre-ferred; minimum two years’ experience at the manager level, with demonstrated leadership qualities and an ability to work with a variety of communication styles; knowledge of standards for cellular therapy and National Marrow Donor Program requirements; familiarity with QA re-quirements, cryopreservation, microbiology, sterile technique, and safe handling of potentially infectious hu-man blood/tissues; proficiency with MS Office applications; and program development experience (pre-ferred). This position also requires the ability to work a flexible schedule and carry a pager. To apply send re-sume/cover letter to: [email protected] or fax: (866) 286-8495.

Reference Technologist. Community Blood Services is looking for a full time reference technologist from Mon.-Fri., noon-8 p.m. This position is responsible for perform-ing all reference laboratory procedures, which requires a thorough understanding of immunohematology and the principles and properties of red cell antigens and antibod-ies, including problem solving abilities. A reference laboratory technologist will provide consultation to hospi-tal clients and may be involved in training staff. Education/experience: bachelor’s degree (BS) from a four-year college or university; BS in medical technology pre-ferred. One to two years’ related experience and/or training, or equivalent combination of education and ex-perience. Minimum of two years’ experience in blood bank, including skill in antibody identification procedures, is mandatory. MT (ASCP) certification, BB or SBB or eligible preferred. Knowledge or experience in flow cy-tometry preferred. Interested and qualified applicants please contact HR at (201) 444-3900 or e-mail your resume to [email protected]. EOE

Laboratory Technologist. The Main Laboratory at the Rhode Island Blood Center has two full time Laboratory Technologist positions available on second shift, with rotating weekends and holidays. The primary responsibili-ties of the technologist position include: routine testing of donor blood samples with proper technique and documen-tation, labeling of blood components, performing and documenting quality control procedures, and generating client reports for donor testing. This position reports to the Director of Laboratory Services, Laboratory Supervisor, and others as designated. Education requirements: bache-lor’s in Medical Technology or Clinical Lab Science and ASCP certification. Must obtain current Rhode Island license as a Clinical Laboratory Scientist or Technician within 120 days of employment. We have earned an excel-lent reputation as an employer of choice, and our culture enables our staff members to perform at their best. We have one of the most competitive benefits and compensa-tion programs available and we offer relocation. Please

apply online at WWW.RIBC.ORG. JOIN THE TEAM THAT GIVES THE GIFT OF LIFE!!! EOE

Director of Training for Blood Collection, RN (Blood-Source). Seeking a dynamic leader to direct and oversee our blood collection training department. Will supervise training staff, and develop, maintain, and present training programs on blood collection processes and equipment, including new hire training, to ensure regulatory and policy compliance. Will develop and oversee position compe-tency programs for all collections duties, including donor registration, donor evaluation, phlebotomy, Trima, and charge nurse responsibilities. Qualifications include: Calif. licensed RN with BSN required. MSN preferred. Training and public speaking experience required. Curriculum development and three years’ leadership experience strong-ly preferred. Blood banking experience desirable. Some travel to other BloodSource sites required. Apply online at: www.bloodsource.org.

Medical Director of Blood Bank/Blood and Marrow Transplant Laboratory. The Department of Pathology at Wake Forest University School of Medicine is accepting applications for the position of Medical Director, Blood Bank and Blood and Marrow Transplant (BMT) Labora-tory. The position includes a tenure track appointment in the Department of Pathology at the Wake Forest School of Medicine at the assistant/associate professor level. The candidate should have an MD with board certification in pathology, hematology, or internal medicine, with subspe-cialty board certification in blood banking/transfusion medicine. The blood bank service provides all transfusion-related support to the Wake Forest University Baptist Medical Center, which is a university tertiary-care facility with active programs in stem cell and organ transplanta-tion, cardiothoracic surgery, hematology and oncology, pediatric and adult level I trauma, and other critical care areas. The BMT service provides all cellular processing support for the medical center’s clinical BMT program. Responsibilities of the position include providing medical, technical, and administrative leadership to the blood bank and BMT laboratories; serving as the liaison between the blood bank/BMT and all clinical services that utilize the laboratories; ensuring compliance with all applicable regu-latory and reimbursement requirements; and overseeing educational activities of the blood bank and BMT laborato-ries. Interested persons should send their CV, including three references, to: Gregory J. Pomper, MD, Director of Clinical Laboratories, Department of Pathology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157. Wake Forest Uni-versity is an equal opportunity/affirmative action employer.

The New York Blood Center (NYBC) has a number of positions open:

• Blood Banking/Transfusion Medicine Physician. NYBC seeks a full-time blood banking/transfusion



POSITIONS (continued from page 17) • medicine physician for an open position as transfusion

service medical director at Westchester Medical Cen-ter. NYBC is one of the nation’s largest non-profit, community-based blood centers, supplying 400,000 red cell units to New York, New Jersey, and Pennsyl-vania. In addition to its core function as a premier collector, processor, and distributor of blood and blood products, NYBC is also home to the Lindsley F. Kim-ball Research Institute and the National Cord Blood Program at the Howard P. Milstein National Cord Blood Center, which is the world’s single largest pub-lic cord blood bank. Westchester Medical Center is a large tertiary care hospital with specialty services in trauma, burn, pediatrics, stem cell transplantation, solid organ transplantation, cardiac surgery, and hema-tology/oncology. This individual would be an integral member of Medical Programs and Services Division of NYBC, which encompasses hemophilia services, transfusion services, therapeutic apheresis, National Marrow Donor Program, transfusion medicine fellow-ship, cellular therapy, and perioperative autologous transfusion, as well as medical oversight of the entire organization. Under the leadership of Beth H. Shaz, MD, vice president of Medical Programs and Services and chief medical officer, with the support of Christo-pher D. Hillyer, MD, president and CEO, this division is undergoing transformation to provide innovative, high-quality service and products. Candidates should have an MD and/or PhD, eligibility for medical licen-sure in New York, eligibility for board certification in blood banking/transfusion medicine, and strong man-agement, communication, and leadership skills. Ample time for scholarly activities as well as a faculty ap-pointment will be provided. Please send letter of interest, current CV, and contact information for three references to [email protected].

• Director, Cord Blood Quality, Long Island City location. Provide oversight, support, and guidance in quality and regulatory issues to the National Cord Blood Program. Oversee quality requirements in all National Cord Blood Program areas. Manage National Cord Blood Program processes to meet FDA cGMP and FACT standards. Function as the liaison with the corporate internal auditor program. Responsible for making recommendations and monitoring current and future standards and implementing training procedures and practices. Requirements: bachelor’s degree (mini-mum) with master’s degree desirable. Experience with Six Sigma or equivalent preferred. Ten years’ experi-ence in quality in a regulated environment, with five years of management experience in quality. Experi-ence with cell manufacturing required. Experience in the preparation and filing of biological license applica-tions helpful. Detail oriented. Excellent communication skills required. Working knowledge of prevailing laws and regulatory requirements, cGMPs, and international standards. To apply, please e-mail your resume to [email protected].

• Data Analyst, NYC. Assists Quality and Regulatory Affairs and Operations in collection and analysis of quality data to determine opportunities for improve-ment and to generate actionable reports. Provides guidance and data management support to quality and operations in the appropriate collection and analysis of data. Requirements: bachelor’s degree required in ana-lytical background. One to two years’ experience in processing data preferred. Advanced knowledge and significant experience with Microsoft Excel, Microsoft Access, and PowerPoint required. Strong analytical skills; ability to create presentations that accurately depict data; excellent verbal and written communica-tion skills. Experience with statistical process control experience very desirable. To apply, please e-mail your resume to [email protected].

• Quality Assurance Specialist, Long Island, New Jersey, Westchester, Manhattan locations. Provide guidance, support, and oversight to operations and other functional groups within NYBC. Support and as-sist management in the Quality and Regulatory Affairs division in all activities related to compliance monitor-ing, Standard operating procedure (SOP) review, and continuous improvement. Under the guidance of direct supervisor, work to ensure that specific assigned re-gion of NYBC is compliant. Cooperate with auditors as needed. Requirements: bachelor’s degree required, preferably in biological sciences, or comparable edu-cation/experience combination. Working knowledge of regulations and standards applicable to blood and tissue establishments. Minimum one year of experi-ence in blood banking, transfusion services, biologics, etc. Minimum two years’ experience in quality-related activities. Experience in conducting audits desirable. Excellent written and oral communication skills. At-tention to detail. Able to conduct limited travel when necessary. Ability to think critically and make deci-sions related to compliance within the blood establishment. Ability to perform root cause analysis. To apply, please e-mail your resume to [email protected].

• Regulatory Affairs Associate, NYC location. Assist Director of Regulatory Affairs in the following areas: preparation/submission of electronic biological prod-uct deviation reports; preparation/submission of biologic license application submissions and state ap-plications and renewals; tracking status and submission of responses to FDA/state/AABB/other de-ficiencies and citations; review of regulatory information to update DRA on developing issues and regulatory requirements. Requirements: bachelor’s de-gree, advanced degree preferred. Three to five years’ experience in regulatory affairs, including preparation of required regulatory submissions, is preferred. Thor-ough demon-




• strated knowledge of federal, state, and AABB regula-tions and standards as they apply to blood center and HCT/P activities. Three to five years’ experience in blood establishment quality is desirable. Must be detail oriented, with attention to accuracy. Excellent com-munication skills, both verbal and written. Ability to interact with others in a calm, professional manner. Thorough working knowledge of basic computer pro-grams. Word/Excel/PowerPoint essential. To apply, please e-mail your resume to [email protected].

• Document Management Specialist, NYC, Long Island City. Assures that regulatory, compliance, and organizational goals are met by managing the official NYBC corporate documents consisting of, but not lim-ited to, standard operating procedures, policies and directives, training manuals. Manages electronic post-ing of documents and ensures documents meet corporate document and graphics standards and are current, accurate, and accessible. Requirements: two-year associate’s degree from an accredited institution or equivalent is required. A minimum of two years of experience in an FDA-regulated environment is re-quired. Training and/or experience in a laboratory is preferred. Quality assurance experience or keen inter-est (demonstrated by self-acquired knowledge or courses) is required. Demonstrated interpersonal skills and customer service focus is required. Must be detail oriented. Must have sound decision-making skills and be able to recognize and resolve most common prob-lems. Must have the ability to handle multiple tasks at one time. Must be proficient in Microsoft software ap-plications, including Word, Excel, and Access; Trackwise and Pulse. Must have a basic understanding of FDA regulations, quality systems, and cGMPs. To apply, please e-mail your resume to [email protected].

• Manager, Customer Relations. NYBC has an open-ing in our Customer Service Department for a Customer Relations Manager based out of our New Jersey location with various territories. In this vital role you will be responsible for ensuring NYBC cus-tomers (hospitals) receive and view NYBC as giving

the highest level of customer service. Strategically po-sitioning NYBC with current and future customers through an added-value partnership while providing a variety of customer service functions including educa-tional tools, seminars, and functioning as a liaison on day-to-day needs. Bridging current and future custom-ers’ current needs with blood products and services of NYBC. This position is also responsible for the sales of all medical service products to new and existing customers while continuing to provide exceptional customer service within geographic boundaries of as-signed territory. Bachelor’s degree required. SBB or MT a plus. Three to five years’ in healthcare, customer service, pharmaceuticals, and/or sales in any variety. Medical technology background a plus. Strong knowl-edge of hospital operations and transfusion medicine. Display proven success in customer service and/or sales. Must have outstanding communication skill (both written and verbal), customer service and rela-tionship development skills. Must have experience in developing new business and networking. Ability to communicate with confidence and using relevant medical terminology a must. To apply please send your resume to: [email protected].

As an employer of choice, New York Blood Center offers an environment that supports and sustains the needs of employees. We understand the demands of your career, your need for autonomous decision-making, and your desire to keep learning. Below are just a few of the benefits we offer to our employees. Health benefits: comprehensive medical, prescription drug, and vision plans. Employer contribution of 7 percent of base salary to a 403(b) retire-ment account; tuition; reimbursement program; medical and dependent care flexible spending accounts; commuter administration services (pre-tax commuter savings account) (CAS). For more information about our company and its benefits, please visit us at www.nybloodcenter.org.

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