Read Microsoft Word - ABC Newsletter 2009, #44 text version

2009 #44

INSIDE:

Our Space: Regarding BECS ........................... 2 ABC Issues Statement Opposing Medical Device Taxes or Fees; Members Reach Out to Dozens of Congressional Representatives in Grassroots Campaign... 3 Leukemia Patients Benefit from Treatment with Two Units of Cord Blood ...... 6 Puget Sound Blood Center Opens New, Expanded Facility .......................... 8 FABC Launches Annual Appeal, Begins Accepting Online Contributions .............. 10 Rise in Paid Plasma Donors Raises Concerns, Draws Media Attention ..................... 12 CMS' New Insurance Reporting Requirement to Affect Blood Centers ................................... 13 Rep. Quigley Leads Coalition Urging FDA to Reexamine Blood Deferrals for Gays ...... 14

December 11, 2009

FDA Clarifies Donor Incentive Rules During ABC Webinar

A Food and Drug Administration official this week laid out the factors that the agency considers in determining whether a blood unit should be labeled as coming from a volunteer versus a paid donor. Helen Cowley made her remarks during a Webinar that America's Blood Centers (ABC) hosted on federal policies on appropriate donor incentives aimed at maintaining an all-volunteer blood supply. Ms. Cowley, a consumer safety officer in the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality, acknowledged that it "can be difficult to determine what constitutes a volunteer donor versus a paid donor, based on the type of incentive being provided." As part of her responsibilities, Ms. Cowley serves as chair of CBER's Blood Donor Incentive Committee, which considers inquiries on donor incentives and offers opinions on whether a particular incentive should result in "volunteer" or "paid" donor labeling. She said that FDA's regulatory framework for labeling is reflected in Section 502 [21 USC 352] and Section 301 [21 USC 331] of the Food, Drug and Cosmetic Act, while the regulations on donor incentives are reflected in 21 CFR 606.121 (c) (5). The regulations are contained in a final rule published in January 1978 for blood products (but not plasma destined for further manufacture). In 2002, the agency published the Compliance Policy Guide, which explains FDA's current thinking on blood donor classification. The Guide was updated in December 2007. The final rule was promulgated after studies published in the 1970s showed that blood from paid donors significantly increased the risk of post-transfusion hepatitis among recipients. "Direct monetary payments for blood donors tended to attract individuals in whom ... hepatitis was prevalent, and this included drug addicts in need of money to purchase drugs," Ms. Cowley said. Accepting blood from only volunteer donors reduces the risk of transfusiontransmitted infectious diseases. FDA considers a volunteer donor to be someone who does not receive a monetary benefit or an incentive for donating that can be readily converted to cash. Items the donor would normally receive during the donation process, such as post-donation refreshments, are not considered benefits or incentives, but anything else the donor receives may be. (continued on page 9)

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December 11, 2009

OUR SPACE

By ABC CEO Jim MacPherson Regarding BECS

The November issue of Transfusion (2009;49:2490-2494) contains a summary of last year's first-of-its-kind conference on what FDA calls Blood Establishment Computer Software, or BECS. The conference was organized by ABC under the Alliance of Blood Operators (ABO) and co-sponsored by FDA's Center for Biologics Evaluation and Research (CBER). ABO also participated in the planning, as did the American Red Cross, AABB, and AdvaMed. The conference attracted 170 participants, most representing blood centers, national organizations, regulators, and software manufacturers. The conference focused on BECS in the US, but the commercial systems available here are largely the same as available elsewhere; they have been developed by a short list of boutique but dedicated and under-financed companies serving a niche market (blood banking). One goal of the conference was to determine whether the unique FDA regulation of US BECS was a boon or a bane. Not surprisingly, it is perceived as both. Quality assurance personnel believe the software is better for the requirements. Information technology staff see regulation as a barrier to timely access to new technology, such as the latest end-to-end systems available from the big software houses that also wish to avoid the FDA regulation that comes with BECS. The conference stimulated a dozen or so initiatives to improve the multitude of IT-related processes, while making FDA, IT companies, and blood centers rethink their approach to this complex subject. For example, the recent CBER-hosted workshop on BECS was based on a recommendation to lessen the real or perceived regulatory burden. An ABC initiative to develop an IT system interface standard (HL7) also had its roots in the conference. Unfortunately, the IT suppliers are not organized in the way test and medical plastics manufacturers are under AdvaMed. Such organization would make uniform communication with companies much easier, and it would provide an ongoing forum for discussion on common regulatory, policy, standards, and operational issues. Despite this deficiency, companies are going more global and looking at common interfaces, while FDA is considering reducing (to Class I) its level of regulation. Good things happen with increased communication.

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The ABC Newsletter (ISSN #1092-0412) is published 46 times a year by America's Blood Centers® and distributed by e-mail. Contents and views expressed are not official statements of ABC or its Board of Directors. Copyright 2009 by America's Blood Centers. Reproduction of the ABC Newsletter is forbidden unless permission is granted by the publisher. (ABC members need not obtain prior permission if proper credit is given.) ABC is an association of not-for-profit, independent community blood centers that helps its members provide excellence in transfusion medicine and related health services. ABC provides leadership in donor advocacy, education, national policy, quality, safety, in finding efficiencies for the benefit of donors, patients, and health-care facilities, by encouraging collaboration among blood organizations, and by acting as a forum for sharing information and best practices.

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December 11, 2009

ABC Issues Statement Opposing Medical Device Taxes or Fees; Members Reach Out to Dozens of Congressional Representatives in Grassroots Campaign

As the US Senate wrangled over a plan to revise the so-called "public option" and several pending amendments of the healthcare reform bill this week, America's Blood Centers (ABC) issued a statement decrying the imposition of fees or excise taxes on medical devices sold to blood centers, which are called for in both the House and Senate versions of the bill. Meanwhile, ABC members continued to advocate for relief from the proposed fees or taxes. "Our concern is that the device tax or fee will increase operating costs for blood centers, thereby limiting their ability to add new blood safety measures. Such measures have virtually eliminated disease transmission at an annual cost of about $1 billion to hospitals above the cost of medical inflation," ABC said in its statement. "To avoid this unfair and unwise burden, Congress should exempt medical devices sold to not-for-profit community blood centers from any medical device excise tax or annual fee included in the final legislation." Since the week before Thanksgiving, officials from at least a dozen ABC member centers have contacted more than 30 lawmakers with the request that they oppose any fee or tax on medical devices sold to blood centers. They also were seeking a member of Congress, preferably a Democratic senator, willing to introduce an exemption amendment granting blood centers relief from the added costs. Details about the Tax or Fee. In both the House and Senate versions, the fee or tax is a way of paying for expanded Medicare-Medicaid coverage for the uninsured. The health reform bill that cleared the House, HR 3962, would establish a 2.5 percent tax at the point of sale of medical devices, with an exemption for retail sales, for a 10-year total of $20 billion. It would be deductible and wouldn't take effect until 2013. The Senate Finance Committee's reform legislation originally included a device fee of $4 billion per year, for a 10-year total of $40 billion ­ twice as much as the House bill. But after advocacy efforts by ABC and other organizations, the Senate version of the bill, HR 3590, that was unveiled before Thanksgiving halved the annual fee to $2 billion, beginning in 2010. This non-deductible fee would be allocated across the industry according to the producer's market share. The fee would not apply to companies with sales of medical devices in the US of $5 million or less. Sales taken into account for purposes of calculating the fee would be 50 percent of a covered entity's gross receipts from medical device sales for the preceding calendar year over $5 million and up to $25 million, and 100 percent of a covered entity's gross receipts from medical device sales for the preceding calendar year over $25 million. The fee does not apply to any sale of a Class I product or any sale of a Class II product that is primarily sold to consumers at retail for not more than $100 per unit. The fee would be imposed on big-ticket hardware items such as automated blood testing machines, automated blood processing/apheresis machines and related kits, and IT systems. It may also be imposed on centrifuges, walk-in freezers, blast freezers, refrigerators and platelet rotators, and testing reagents. ABC's Honor Roll. Among ABC members actively advocating against the bill:

Carrie Aiken, communications coordinator at Blood Bank of Delmarva, has reached out to Delaware Rep. Michael Castle (R-At large) and Delaware Sens. Thomas Carper (D) and Ted Kaufman (D). Ms. Aiken

(continued on page 4)

ABC Newsletter Medical Device Update (continued from page 3)

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December 11, 2009

has also contacted staff of Maryland Rep. Frank Kratovil Jr. (D) and Maryland Sens. Benjamin Cardin (D) and Barbara Mikulski (D). Leslie Botos, vice president, Public Affairs at BloodSource, and her staff contacted the entire delegation representing Northern and Central California. Phyllis Erickson, CEO of Nebraska Community Blood Bank, reached out to staff of Sen. Mike Johanns (R-Neb.) and Sen. Ben Nelson (D-Neb.). Danny Garrick, COO, and Susan Berry-Buckley, CEO, of Mid-South Regional Blood Center/Lifeblood in Memphis, Tenn., have contacted staff of Sen. Bob Corker (R-Tenn.), Sen. Lamar Alexander (R-Tenn.), and Rep. Steve Cohen (D-Tenn.). Peter Hanney, manager, Donor Recruitment, Rhode Island Blood Center, contacted staff of Rhode Island Reps. James Langevin and Patrick Kennedy and Sens. Jack Reed and Sheldon Whitehouse, all Democrats. Barb Kain, director, PR/Communications for Blood Systems/United Blood Services (UBS), coordinated outreach with the organization's UBS centers in Arizona, Montana, Arkansas, and North Dakota. Audrey Jennings of UBS contacted Arizona Sens. Jon L. Kyl (R) and John McCain (R), William Henry contacted staff of Sen. Max Baucus (D-Mont.), Terry Ridenour reached out to Sen. Blanche L. Lincoln (D-Ark.), and Connie Morris made contact with staff of Sen. Kent Conrad (D-N.D.) Louis M. Katz, MD, executive vice president, Medical Affairs, Mississippi Valley Regional Blood Center (MVRBC), met with staff of Rep. Dave Loebsack (D-Iowa) on Capitol Hill with ABC staff and the organization's legislative attorney. He has also attempted to contact staff of Sen. Tom Harkin (D-Iowa). Jacky Kocz, executive director of Community Blood Bank of Northwest Pennsylvania, reached out to and is making arrangements to meet with staff of Sen. Arlen Specter (D) and has contacted staff of Rep. Glenn W. Thompson Jr. (R-Pa.). Libby Murphy, director of Development and Public Relations at LifeShare Blood Centers in Louisiana, has committed to meeting with staff of Sen. Mary L. Landrieu (D-La.). Jan Twait, CEO of Siouxland Community Blood Bank in Iowa, has joined ABC staff and Dr. Katz in attempting to contact staff in Sen. Harkin's office. Margaret Vaughn, director of Government Relations for the Illinois Coalition of Blood Centers, reached out to staff of Sen. Richard Durbin (D-Ill.), with Roxanne Tata, vice president and COO of LifeSource in the Chicago area, and Kirby Winn, director of Public Relations at MVRBC, both volunteering to attend the meeting when it is set.

On behalf of the entire blood community, ABC CEO Jim MacPherson thanked the members who have advocated against the fee. "The strength of ABC in legislative issues rests on the strength of our members' ties to their communities and elected officials," he said. "We cannot thank our members enough for their support." Latest Developments. A tentative agreement announced on Tuesday night seemed to indicate that Democrats were retreating from the proposed government-run insurance plan or public option, which is opposed by some centrists. The plan appeared to favor a proposal that would essentially be an expansion of Medicare. Rank-and-file Democrats said the preliminary agreement ­ reached by a group of 10 senators, five liberals, and five centrists ­ suggested that they would be able to resolve some seemingly intractable differences over the public plan, insurance coverage for abortions, and other disputes, including how to pay for the nearly $1 trillion bill. While the revised public option plan has thrown a monkey wrench into the works, it may make it easier for Senate Democrats to get the 60 votes needed to move to a cloture vote to override a filibuster. (continued on page 5)

ABC Newsletter Medical Device Update (continued from page 4)

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December 11, 2009

(Editor's note: Under the cloture rule, the Senate may limit consideration of a pending matter to 30 additional hours, but only by vote of three-fifths of the full Senate, normally 60 votes.) How fast the bill advances depends on a number of factors. First there are several pending amendments to resolve. On Wednesday, the Senate rejected an amendment that would prohibit the use of federal funds to cover abortions. The amendment would have made an exception for abortion in the cases of rape, of incest, or in which the life of the mother was in jeopardy. Though the vote has been carried out, the issue continues to be a dividing factor among Senate Democrats and is a viable threat to the healthcare reform bill. US Sen. Kay R. Hagan (D-N.C.) this week also introduced a series of amendments to improve pricing and transparency of healthcare services. One would require insurance companies to publicly report reimbursement rates paid to providers and hospitals for benefits and services. A cloture vote was expected sometime this week to end debate on the Senate healthcare bill. But the revised public option plan has not been drafted, offered, or scored by the Congressional Budget Office (CBO). The CBO scoring, which normally takes five days, is expected to be issued sometime early next week. When the Senate does vote on the revised bill, it will go back to the House, which may vote again before the bill is taken up in conference committee to reconcile differences between the two versions. The healthcare bill approved by the House includes a government-run plan, and persuading the more liberal House Democratic caucus to drop it will be a challenge. Centrist Sen. Mary Landrieu (D-La.) and other senators emphasized that they are withholding any promises until they hear from the CBO about the cost of the new proposals. "Until it's scored we really just can't talk about the specifics because the scores will have a great effect on what's ultimately done," Sen. Landrieu told The New York Times. Trying to guess the timeframe for the bill is a fool's errand. "The prospects of finishing before Christmas are highly optimistic," a source on the Republican side told the ABC Newsletter. (Sources: The New York Times, 12/10/09; The Washington Post, 12/09/09; The Hill, 12/10/09; Gallerywatch, 12/10/09)

On the Evergreen Quality of Healthcare Reform

"`At present the United States has the unenviable distinction of being the only great industrial nation without compulsory health insurance,' the Yale economist Irving Fisher said in a speech in ... December of 1916. More than nine decades ago, Mr. Fisher thought that universal health coverage was just around the corner. In 1912, the American Association for Labor Legislation ... formed the Committee on Social Insurance, the brainchild of Isaac M. Rubinow, MD, a Russian-born doctor and author of the landmark study `Social Insurance.' Dr. Rubinow hoped that `sickness insurance' would help eradicate poverty. ... By 1915, Dr. Rubinow's committee had drafted a bill providing for universal medical coverage. `No other social movement in modern economic development is so pregnant with benefit to the public,' the editor of The Journal of the American Medical Association wrote. The next year, Congress began debating Dr. Rubinow's bill, which was put forward in 16 states. It looked like this thing was good to go.... You can probably already see where this is heading. The United States declared war with Germany in April 1917. Health care was dead."

­ Excerpted from an essay by Jill Lepore in The New Yorker, 12/7/09

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December 11, 2009

Leukemia Patients Benefit from Treatment with Two Units of Cord Blood

Researchers in Minnesota recently found that patients with leukemia have better outcomes if they are treated with two units of umbilical cord blood (UCB), rather than just one. Although getting more cord blood raises patients' risk of acute and chronic graft-versus-host disease (GVHD), it also significantly lowers their likelihood of experiencing a recurrence of leukemia. According to a press release from the university, "This finding has the potential to change the current medical practice of using one unit of UCB for treatment of patients who are at high risk for recurrence of [leukemia] and other cancers of the blood and bone marrow." The study was carried out by Michael R. Verneris, MD, and his colleagues in the Blood and Bone Marrow Transplant Program and the Departments of Pediatrics, the Department of Medicine, and the Department of Laboratory Medicine and Pathology, all at the University of Minnesota Medical School in Minneapolis. The results were published in the Nov. 5 issue of Blood, which also included an editorial about the work by Meghan Delaney, MD, of the Puget Sound Blood Center. The findings are particularly significant because treating leukemia patients with UCB has a number of benefits over treating them with bone marrow, Dr. Delaney explained. However, the limited number of stem cells in a single unit of UCB means a single unit can be used only in infants, children, or small adults. Treating patients with two units of UCB, which the university said was pioneered by researchers there about 10 years ago, allows UCB to be used for larger patients as well. Dr. Verneris and his colleagues aimed to study the risk factors associated with leukemia relapse after transplantation of UCB, comparing those experienced by patients who received two units to those experienced by patients who received only one. Methodology. The researchers studied 177 patients with acute lymphoblastic or acute myeloid leukemia who received UCB transplants at the University of Minnesota between July 1994 and March 2008. The patients ranged from 6 months to 57 years old; their average age was 16. Based on their needs as established by cell dose criteria (which changed in 2002), patients received either one or two units of UCB. Forty-seven percent received one unit; 53 percent received two. Data were collected and analyzed on patient characteristics and transplant-related outcomes, including GVHD, mortality, relapse, survival, and leukemia-free survival. For patients who received two units, the researchers also measured the contribution of each UCB unit to engraftment. Findings. Recipients of two units had a significantly lower risk of leukemia relapse than those who received one unit (19 versus 34 percent, respectively, after five years). The difference was even more pronounced for patients who were in their second relapse of the disease (18 percent for double-unit and 40 percent for single-unit recipients). However, patients who received two units of UCB were significantly more likely to experience acute GVHD than those who received only one (48 versus 29 percent, respectively). Double cord recipients also were more likely to experience chronic GVHD (18 percent versus 10 percent for single cord recipients). The rates of overall survival and leukemia-free survival remained fairly similar whether patients received one or two units of UCB. However, Dr. Verneris explained in the university's press release that adult patients, who were more likely to receive two units of UCB, were also more likely to have more aggressive leukemia. The similar survival rates, then, suggest the benefits of double-unit transplantations. He (continued on page 7)

ABC Newsletter Cord Blood and Leukemia (continued from page 6)

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December 11, 2009

called the lower relapse rates with double-unit transplantations remarkable, given the characteristics of the recipients of that treatment. Dr. Verneris and his colleagues wrote in their report that their results need to be confirmed before a recommendation could be made that all patients with acute leukemia receive two units rather than one of UCB. They also called for a prospective, randomized study in children with the disease. But they concluded that their results confirm the usefulness of treating adults with leukemia with two units of UCB. (Source: University of Minnesota press release, 11/16/09) Citations. Verneris MR, et al. Relapse risk after umbilical cord blood transplantation: enhanced graftversus-leukemia effect in recipients of 2 units. Blood. 2009 Nov 5;114(19):4293-9; Delaney M. "Are 2 Cords Better than 1?" Blood. 2009 Nov 5;114(19):3980-1.

BRIEFLY NOTED

Non-profits are eligible to apply for R01 grants from the National Institutes of Health that support hematology research relevant to diabetes, digestive, and kidney diseases. Three or four grants will be made in fiscal year 2010 through the Stimulating Hematology Investigation: New Endeavors (SHINE) program, for a total of up to $1.25 million. The program supports "basic and translational hematology research where needs and opportunities for progress are particularly timely," according to the grant announcement. The deadline for the first cycle of grants is Feb. 5, 2010, with additional deadlines in June and October. Full details are available at http://grants.nih.gov/grants/guide/pa-files/PAS-10-046.html. Bone marrow transplants headed a list of the 10 procedures with the most rapidly increasing hospital costs, according to a report released in December by the Agency for Healthcare Research and Quality. The report compared the number and cost of procedures performed from 2004 to 2007. It found that hospital stays for bone marrow transplants rose to 15,100 in 2007, a 51.3 percent increase from 2004. The aggregate cost for those procedures grew 84.9 percent, to $1.3 billion annually by 2007. Bone marrow transplants topped the lists for both numbers, in terms of the percent increases. The authors of the report, led by Elizabeth Stranges, wrote in their introduction that "indentifying the procedures that generate the most rapid increases in hospital costs may contribute to a more informed discussion of overall cost increases." They drew their data from the Healthcare Cost and Utilization Project, and they adjusted costs for 2004 to 2007 dollars using the overall Consumer Price Index. During the four-year period they studied, overall hospital costs rose by 6.3 percent to $344 billion, inflation adjusted. The full report is available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb82.pdf. Last month, President Obama created the Presidential Commission for the Study of Bioethical Issues. He announced the new commission on Nov. 24, when he appointed Amy Gutman, PhD, president of the University of Pennsylvania, as its chair, and James Wagner, PhD, president of Emory University, as its vice chair. Mr. Obama said of the commission, "As our nation invests in science and innovation and pursues advances in biomedical research and health care, it's imperative that we do so in a responsible manner. This new Commission will develop its recommendations through practical and policy-related analyses." It will advise the President on bioethical issues related to advances in biomedicine and related areas of science and technology, and its goal will be to identify and promote policies and practices ensuring the ethically responsible conduct of scientific research, health care delivery, and technological innovation, according to the White House. Dr. Gutman is a political scientist. Dr. Wagner is an engineer; early in his career, he worked as a researcher for the Food and Drug Administration Center for Devices and Radiological Health. (Source: White House press release, 11/24/09)

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December 11, 2009

Puget Sound Blood Center Opens New, Expanded Facility

Puget Sound Blood Center (PSBC) vastly expanded its space and significantly streamlined its blood testing processes in mid-October, when it opened up a new 65,000 square foot facility next door to its existing facility in Renton, Wash. Michael Young, PSBC's director of communications, said in a phone call that there wasn't a lot of space in the blood center's old building. The center went through a LEAN workshop led by a consultant with the Boeing Company in 2007 to try to find an efficient way to reconfigure its laboratories. But the workshop showed that PBSC needed a new, bigger space to streamline the flow of its operations, particularly those related to incoming donations and associated testing. The center bought the new building ­ which is two-and-a-half times the size of the old one ­ in December 2007 and renovated it completely. PSBC staff began to move in this fall. A number of the center's departments have now relocated to the new building, including Material Management, Donor Testing, Inventory Production, and Inventory Management. The center's Blood Collection Services Information Specialists, who review donor records, also have their offices in the new building.

Carolyn Houk of Lane Memorial Blood Bank, Sandra Rodriguez and Monica Freire of LifeStream, and Debbie Fletcher of Puget Sound Blood Center celebrate the opening of PSBC's new building on Oct. 13.

The layout of operations in the new space has made the entire organization more efficient, the center said in a release. In particular, it shortens the turnaround time for testing donated blood by one to two hours. The center not only tests its own donations, but also provides testing to a number of clients, including the Armed Services Blood Bank Center-Pacific Northwest, Lane Memorial Blood Bank, LifeStream in Southern California, Blood Bank of Hawaii, and Blood Bank of Alaska. Representatives from a number of those centers were on hand on Oct. 13, when Puget Sound Blood Center hosted a dinner and offered tours of the new facility. The new building also will allow the center to continue expanding its testing capabilities, since it now has space to bring in new equipment, and it will allow the center to participate in clinical trials to develop and license new testing equipment. (Source: Puget Sound Blood Center press release, 12/1/09)

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 cycle.

ABC Newsletter

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December 11, 2009

FDA Clarifies Acceptable Donor Incentives (continued from page 1) The factors that help the FDA determine whether an incentive can be converted to cash are: whether the incentive is transferable, which means that someone other than the donor can use the incentive; whether the incentive is refundable or redeemable for cash (i.e., the donor can take it to the organization that provided the incentive and receive cash for it); and whether a market exists for the incentive, and if one does exist, whether the incentive can readily be converted to cash. During inspections, blood centers that mislabel products as coming from volunteer donors if they have come from donors who have received payment will receive a Form 483 for misbranding. To help ensure that blood centers comply, she said, they should have SOPs in place to establish a process for determining and documenting whether an incentive is acceptable for a volunteer donor label. Incentives that might permit "volunteer donor" labeling include:

Lotteries/raffles; Scholarships to schools (as long as the money goes directly to the educational institution and not the student recipient); Gift cards (gas, phone, food, and music downloads) if non-transferable and no market exists; Tickets to events (sporting and entertainment) if non-transferable and no market exists; Cell phone (donor must sign up for service); Points program for gifts (preferably if there is a built-in delay between donation and obtaining a gift); Novelty items, such as hats and key-chains; Vouchers/certificates to third-party vendors for purchase of item for donation group; Airline frequent flyer points; Credit toward fulfilling community service; Extra credit toward grades; Charitable donations; Vouchers for health tests; Credit toward blood processing fees (as long as the donor does not receive payment through their insurance carrier); and Paid time off, if it is not readily convertible to cash.

Incentives that might require "paid donor" labeling include:

Tickets to events (sporting and entertainment) if transferable and a market exists; Gift cards (gas, phone, food, and music downloads) if transferable and market exists; Cash award to a group to which the donor belongs; and Cash award to a high school (general fund).

Tickets to collegiate or professional sporting events and concerts "can be very tricky," she said, because often a market exists in the form of ticket scalping. Merely labeling a ticket "not transferable" is not enough to support a volunteer donor labeling. A mechanism must be in place to assure non-transferability, such as having the ticket bear the donor's name. Another "confusing issue" involves cash awarded to a group to which the donor belongs. Even if the money goes into the group's general fund, it might still be deemed a form of payment, unless the money is paid to reimburse the organization for the costs of holding a blood drive. (Editor's note: ABC does not support laws that provide tax deductions to individuals in exchange for donations or laws that give employees additional compensatory time that can then be redeemed for cash. ABC supports in concept laws that offer businesses tax credits to cover the loss of productivity when an employee donates or attempts to donate blood on company time.)

ABC Newsletter

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December 11, 2009

INSIDE ABC

FABC Launches Annual Appeal, Begins Accepting Online Contributions

The Foundation for America's Blood Centers (FABC) on Wednesday launched its annual fundraising campaign with a goal of $15,000 from individual donors. Money raised will support the operations of FABC and its programs, which include grants to members of America's Blood Centers (ABC). On its first day, the campaign raised $1,540, inspired by an e-mail from Michelle Stefan, chair of FABC, to nearly 1,700 contacts. Ms. Stefan emphasized that individual contributions are an integral part of FABC's fundraising efforts. Contributors will be listed on FABC publications, and those who contribute $2,500 or more will receive special recognition. Online Donations Possible. To make contributing easier, FABC recently unveiled a new electronic contribution form that allows supporters to donate online using Visa or MasterCard. It processes credit cards in a secure and efficient way. The online contribution form can be found at http://bit.ly/FABCnews. "The ability to take financial gifts on our Web site is a huge step forward," Ms. Stefan told the ABC Newsletter. "It has opened the doors to scores of individual contributors who would have otherwise not written a check; plus it has saved us from spending time and money in printing, postage, and check processing." Donations also can be mailed to FABC, 725 15th St. NW, Ste. 700, Washington, DC 20005. Donors are urged to make their gifts by Dec. 31 to take advantage of a year-end tax deduction. Donations Support Important Initiatives. FABC operates with an all-volunteer board and no paid staff of its own. Yet in the past year, it has been able to maintain the momentum of For the Sake of the Patient ­ a focused fundraising effort ­ and bring back the Member Grants Program. It also awarded grants totaling $253,000 to five ABC members for initiatives that range from promoting participation in blood donation in young and ethnically diverse populations to providing wellness information to individuals to encourage repeat and healthy donors. Since its establishment in 1997, FABC has provided funding to many ABC members for operations and educational programs that promote and raise awareness of the need for volunteer blood donation. All of the resources, tools, and other materials, including plans and strategies, developed by funding provided by FABC are available to all ABC members. Among the programs funded recently through the Foundation was the development of a Multicultural Donor Diversity Guide, which offers blood centers recruitment or retention-focused strategies to successfully tackle the growing multicultural market in the US. Last summer, a small investment by FABC through the National Initiatives grant awarded to ABC, resulted in millions of dollars in donated media during the celebration of World Blood Donor Day. ABC members' give partnership with Nexcare (continued on page 11)

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December 11, 2009

Bandages resulted in more than 65 million media impressions from TV, online, newspapers, magazines and radio stations nationwide, with an estimated media value of more than $10 million. In 2006, BloodCenter of Wisconsin was awarded a grant by FABC to launch a comprehensive study of RFID application though the entire flow of blood and blood products from collections through transfusion. The project recently received additional funding from the National Institutes of Health. Ms. Stefan said that FABC hopes to continue to provide ­ and even expand ­ funding opportunities in 2010. All programs will contribute to the efficiency of blood collection and strengthen the nation's blood supply. International Ties Lead to Significant Donation for FABC Last week, the Belgian Red Cross ­ Flanders (Rode Kruis Vlaanderen - RKV) made a 5,000 ($7,400) contribution to the Foundation in appreciation for the advice and assistance received from America's Blood Centers during RVK's recent strategic planning process. "Our international partners recognize the value of our interaction," stated Jim MacPherson, CEO of ABC and an FABC board member. "In this case, Dr. Philippe Vandekerckhove from RVK felt that supporting our Foundation was an ideal way to say thank you not just to ABC but also to the blood centers FABC supports." ASK ABC Editor's Note: The ABC Newsletter periodically answers questions posed by members of America's Blood Centers in a recent survey. Q: A: How can I learn and network with others in similar positions to best accomplish my goals? Each year America's Blood Centers (ABC) holds workshops for a range of blood banking disciplines including Fund Development, Communications, Donor Recruitment, Human Resources, Quality, Medical, and Finance. The workshops are held in various locations across the country and focus on ever-relevant issues and "hot" topics. Workshops provide members the opportunity to network with their peers and learn about the latest in blood banking. These workshops are open to any person employed at an ABC member centers and invited guests. ABC also hosts a variety of Webinars. Like the workshops, they allow individuals to learn from the successes and challenges of their peers, share best practices, and ask questions about the latest issues and trends. Webinars and workshops are listed in the calendar on the ABC Members' Web site at http://members.americasblood.org. Members also can communicate with each other by joining listservs related to their discipline. A listserv is a fast and easy way to begin a discussion thread, ask questions to the group, and find out the latest on the issues that affect your daily work directly from your peers. Archives are kept on the ABC Listserv, and they are searchable by topics. Listservs also act as a library of resources where members post materials related to their most successful programs. Any individual employed at an ABC member may join. Visit the ABC Members' Web site for a list of available listservs and instructions for joining.

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December 11, 2009

Rise in Paid Plasma Donors Raises Concerns, Draws Media Attention

The New York Times ran an article on the front page of its business section on Sunday about whether paying plasma donors raises the risk of contaminated blood products. The author, Andrew Pollack, focused particularly on plasma centers near the US's southern border, which draw donors from Mexico for whom the payments represent significant sources of income. In case blood centers receive queries from the media related to the story, Mack Benton, MJ, manager of communications for America's Blood Centers (ABC), on Monday sent out talking points about paid and volunteer donors of plasma. (The talking points, written Dec. 12, 2008, are available to members in the File Center of ABC's members Web site.) Safety Concerns. Mr. Pollack's article highlights a number of concerns from critics of paid plasma donations, starting with whether people who need the money are honest about their health. If the financial compensation leads them to hide risky behavior or illness, critics worry, their donated plasma could be contaminated. Plasma companies ­ and federal regulators ­ counter that "the practice is legal, ethical, and safe," according to Mr. Pollack. He adds that "there have been no known cases of an infectious disease being transmitted through plasma products for more than a decade." ABC's talking points mention that the screening process for plasma donors is as rigorous as the one for whole blood donors, and that plasma products are treated with viral inactivation procedures, which render any viral contaminants harmless. Paying plasma donors also raises questions about the safety of the donors themselves, particularly because they can donate plasma as often as 104 times a year, or twice a week, in the US. Although some of the donors who spoke to Mr. Pollack mentioned that the donation process can leave them lightheaded or tired, donors who have adequate nutrition (vitamins are recommended) seem to experience no ill effects. Jay Epstein, director of FDA's Office of Blood Research and Review, emphasized to Mr. Pollack that the procedure is safe. The Effect on Blood Centers. Mr. Pollack also discusses the question of whether paid plasma donations draw people away from unpaid whole blood donations. As the plasma industry has grown in the past few decades ­ the number of paid donations in the US rose from 10.4 million to 18.8 million just between 2005 and 2008, according to Mr. Pollack ­ some are concerned that people who have been volunteer blood or plasma donors will switch to selling plasma. Mr. Pollack quotes Doug Klynstra, donor recruitment manager at Michigan Blood, an ABC member, about this issue. Mr. Klynstra points out that the economic downturn may contribute to this trend. Mr. Pollack also quotes ABC CEO Jim MacPherson, who emphasizes that plasma donors in the US account for about half of the world's supply. (Sources: The New York Times, 12/6/09; "Talking Points ­ Plasma (Paid vs. Unpaid)," http://members.americasblood.org)

REGULATORY NEWS

The Food and Drug Administration announced this week that it has approved the first platelet additive solution to replace approximately 65 percent of the donor plasma for storing platelets. A portion of this donor plasma can now be used for other purposes. FDA's approval of InterSol, manufactured by Fenwal Inc. of Lake Zurich, Ill., is for Amicus-derived apheresis platelets; Intersol (continued on page 13)

ABC Newsletter

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December 11, 2009

REGULATORY NEWS (continued from page 12) cannot be used for platelets made with other products, such as Caridian. The approval allows for the storage of Amicus-derived apheresis platelets in 65 percent InterSol / 35 percent plasma for up to five days. The FDA noted that the InterSol solution doesn't have a therapeutic effect by itself, but acts to provide nutrients and an appropriate environment in which to store platelets. "The approval of InterSol is a significant step in the development and marketing of novel processes for the storage of platelets," Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, told United Press International. (Source: www.fda.gov, 12/10/09)

CMS' New Insurance Reporting Requirement to Affect Blood Centers

Workers compensation, liability, and health claim payments made by blood centers must be reported to the Centers for Medicare/Medicaid Services (CMS), according to a new CMS regulation that requires blood centers to report to CMS all voluntary payments to injured third parties within their liability insurance policy deductibles or self-insured retention (SIR) specifications. (Editor's note: SIR is the amount in a liability insurance policy that the insured must pay before the insurance company pays. Unlike a deductible, which the insured pays to the insurer, SIR is paid directly to the claimant by the insured.) The rule is the result of federal legislation passed in 2007 (section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007). The requirement applies whether the payment is made by an insurance company or by an insured. Penalties for noncompliance are $1,000 per claim, per day. Through Dec. 31, 2011, payments totaling $5,000 or less to a single claimant for the same injury do not need to be reported. Starting on Jan. 1, 2012, this threshold will start to decrease. Each blood center which expects to pay claims that are in excess of the threshold will have to register with CMS as a Risk Reporting Entity (RRE). According to the Community Blood Centers' Exchange RRG, or BCx, the process of reporting is complicated and can require that up to 140 fields of data be completed. Only CMS software can be used as the reporting mechanism, and it is not an on-line, Web-based process. The reporting will be tested in the first quarter of 2010 and actual reporting will start in the second quarter of 2010 on a date assigned to each RRE by CMS. BCx has educated all of its insureds of the requirement and has registered them. BCx will be the reporting agency on behalf of its insureds for payments made by the blood center. To learn more about this CMS requirement, contact Brad Ellis at (913) 529-3213 or [email protected]

LEGISLATIVE NEWS

The state of Oklahoma may be better served by joining a regional umbilical cord blood bank instead of creating its own bank, a Senate panel was told earlier this month. The Senate Appropriations Subcommittee on Health and Human Services conducted an interim study on the costs of a public cord blood bank. Legislation passed in 2008 authorized the Oklahoma State Department of Health to work to establish a program pending funding. Mark Newman, the department's director of state and federal policy, said Oklahoma does not have enough births to support a blood bank. A successful bank will require 3,000 to 5,000 usable samples per year. The state's 50,000 live births per year would produce only 1,000 usable samples, Mr. Newman said. "Of those that donate, only so many will be usable samples," he said. The state may want to consider becoming part of a regional bank, he said. Sen. (continued on page 14)

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December 11, 2009

LEGISLATIVE NEWS (continued from page 13)

Jay Paul Gumm, D-Durant, said the 2008 legislation allowed for entry into a regional bank. He said he realizes that the state does not have the money right now to create a cord blood bank, but he wants a proposal to be ready to go when the economy improves. John Corpolongo, director of SoonerStart for the state Health Department, said a blood bank would cost about $5 million in startup funding and require even more in operational costs. (Source: Tulsa World, 12/4/09)

Rep. Quigley Leads Coalition Urging FDA to Reexamine Blood Deferrals for Gays

US Rep. Mike Quigley (D-Ill.) and 10 other members of Congress sent a letter this week to the Food and Drug Administration urging the agency to reexamine its lifetime deferral policy for blood donation by gay men. In a press release issued Tuesday, Rep. Quigley's office explained that "the FDA's current policy permanently bans men who have had sex with men from donating blood, while still permitting heterosexual individuals who have had sex with an HIV-positive partner to donate samples after a one-year deferral period." Rep. Quigley's letter to new FDA Commissioner Margaret Hamburg, MD, was co-signed by Reps. Jared Polis (D-Colo.), Jerrold Nadler (D-N.Y.), Diane E. Watson (D-Calif.), Barbara Lee (D-Calif.), Debbie Wasserman Schultz (D-Fla.), Sam Farr (D-Calif.), Tammy Baldwin (D-Wis.), Michael M. Honda (DCalif.), and Raul M. Grijalva (D-Ariz.). This is the second time this year that a group from Congress has asked the FDA to revise its policy regarding gay blood donors. In April, seven members of Congress, led by Rep. Watson, asked the agency to reconsider the lifetime blood donation deferral for gay men in favor of a one-year deferral policy. The most recent letter argues that the ban is no longer necessary, given technological advances and a growing demand and vital need for life-saving blood. The letter acknowledges the FDA's reliance on scientific data to determine its policies and, therefore, requests that the Administration conduct the necessary studies to ensure the safety of all those who undergo blood transfusions. "We are not alone in our call for a reexamination of this outdated policy," the letter says. "The American Medical Association supports changing the current lifetime deferral policy to a five-year deferral policy. ... Additionally, in March 2006, the AABB, America's Blood Centers and American Red Cross ... [called for] the deferral period for male to male sex be changed to 12 months, in order to make it `consistent with the deferral period for other potentially high risk sexual exposures.' The current policy creates a double standard where donors judged to be high risk due to heterosexual behavior are deferred for one year, while men who have had sex with another man even once since 1977 are permanently deferred." The letter points out that the current FDA guidance determining eligibility for the donation of human tissues is inconsistent with its MSM blood donation deferral policy. A man who has had sex with another man in the preceding five years, rather than since 1977, is considered ineligible to donate tissues. The FDA's guidance for tissue donation also defers persons who have had sex in the last 12 months with any person with HIV. "These policies seem inconsistent and worthy of further examination," the letter says. Other nations have reexamined and altered their blood donation deferral policies, the letter points out. Sweden recently announced that on March 1, 2010, its deferral period for men who have sex with men (continued on page 15)

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December 11, 2009

LEGISLATIVE NEWS (continued from page 14)

will be changed to 12 months. Spain and Italy have adopted blood donation policies based on unsafe sexual activity, and Argentina, Australia, Japan, and Hungary all call for deferral of men who have had sex with men for one year after sexual activity. "According to the FDA's Web site, the agency `remains willing to consider new approaches to donor screening and testing, provided those approaches assure that blood recipients are not placed at an increased risk of HIV or other transfusion transmitted diseases,'" the letter states. "We are calling on the FDA now to uphold this claim and reexamine its antiquated, discriminatory deferral policy that currently prevents healthy, disease-free men who have had sex with other men from donating blood."

INFECTIOUS DISEASE UPDATES

Researchers in Texas have found that West Nile virus (WNV) can remain in people's kidneys for years and can lead to kidney problems. The study was led by Kristy Murray, DVM, PhD, of the University of Texas School of Public Health in Houston; its results were published in January in The Journal of Infectious Diseases and were recently posted online. The findings challenge the previously held belief that humans remain infected with WNV only for a few days after their initial infection. Instead, Dr. Murray and her colleagues found that more than half of their study participants had infection-related symptoms for years after their initial illness, and they found viral DNA in some participants' urine for at least six years after their infection. The researchers followed more than 100 patients in Houston for seven years, evaluating them and collecting blood samples every six months. After five participants died of kidney failure, the researchers began collecting urine samples from 25 patients, all of whom were part of the original group of 100. Of those 25, five tested positive for the virus, with viral RNA detectable in their urine. Although the researchers call for further study of the presence of the virus in urine and its relation to kidney disease, they urge patients who have been infected with WNV to have their physicians monitor their kidney function. (Source: www.promedmail.org, 12/9/09)

GLOBAL NEWS

An outbreak of dengue fever in northeast Australia has caused the local blood service to limit who may donate blood. The blood bank in the coastal city of Townsville will now use only the plasma from donations made by Townsville residents. The ban on blood donations from residents will be reconsidered three months after the last diagnosed case of dengue. Bruce Miller, who is with the area's Red Cross Blood Service, said the public health department "declared the outbreak after just one case," out of concern that there could be "a significant number of symptomatic people infected by dengue in the community." During previous outbreaks in the area, the blood service managed the risk of contaminated blood with similar restrictions. Mr. Miller said a mobile donor unit will be set up nearby to help increase blood supplies. (Source: www.abc.net.au, 12/7/09) The threat of Variant Creutzfeldt-Jacob disease (vCJD) ­ the human form of mad cow disease ­ is leading to changes in blood donor deferrals in Ireland and new recommendations for filtering donated blood in the UK. The Irish Blood Transfusion Service has broadened its deferrals of potential blood donors to include people who have lived in Northern Ireland or the UK for more than a year, as well as people who have had transfusions in the past. Dr. William Murphy, the medical director of the Irish Blood Transfusion Service, told The Belfast Telegraph that the threat of vCJD was "unknown but (continued on page 16)

ABC Newsletter

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December 11, 2009

STOPLIGHT: Status of the ABC Blood Supply, 2008 vs. 2009

8% 20% 5% 13% 3% 16% 2% 17% 4% 20% 14% 2% 2% 12% 1% 15% 3% 3% 11% 17%

Percent of Supply

62% 70% 21% 2%

10/29/08 10/28/09

69%

64%

64%

67%

80%

73%

80%

76%

13%

11/5/08

17%

11/4/09

14%

15%

6%

11%

7%

4%

11/12/08 11/11/09

11/19/08 11/20/09

12/10/08 12/9/09

No Response

Green: 3 or More Days

Yellow: 2 Days

Red: 1 Day or Less

GLOBAL NEWS (continued from page 15) serious." The disease has caused the deaths of four people in Ireland, although none of the cases were linked to blood or blood products. In the UK, the Advisory Committee on the Safety of Blood, Tissues, and Other Organs has recommended that red blood cells should be filtered to remove the infection that causes vCJD ­ if they are going to be transfused to patients born since Jan. 1, 1996. The decision to not require the filtering for red blood cells going to patients older than 13 puzzled critics, given that there have been five cases of transmission of vCJD through blood transfusions. The medical equipment necessary for filtering the entire blood supply in the UK could cost as much as £75 million. A total of 166 people have died from vCJD in the UK since it emerged in the mid-1990s. (Sources: belfasttelegraph.co.uk, 11/30/09; guardian.co.uk, 11/26/09)

MEMBER NEWS

CBCC Awards Scholarships for Student Blood Drive Coordinators The Community Blood Center of the Carolinas (CBCC), headquartered in Charlotte, N.C., announced this week that it has awarded $1,000 scholarships to four area students who coordinated community blood drives as part of CBCC's "Saving Summer Scholarship" program. The recipients are: Shannon Williamson, a student at Phillip O. Berry Academy of Technology; Chelsea Penner, a student at Kings Mountain High School; Alex Childress, a student at Lake Norman High School, and Tina Freeman who was homeschooled at T&T Christian Academy and now attends South Piedmont Community College in Monroe. CBCC awarded scholarships to the top four students who had the largest number of people donate at their blood drive between June 1 and Sept. 30. Participating students were each paired up with a CBCC representative and then coordinated all aspects of a community blood drive, including choosing a location, selecting a date and time, and recruiting friends and family to donate. Each CBCC scholarship donation will be directly transferred to the college, university or other learning establishment that the winning student attends after high school. (continued on page 17)

ABC Newsletter MEMBER NEWS (continued from page 16)

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December 11, 2009

"Hats off to all the participating students and these scholarship winners who each played a tremendous role in coordinating blood drives to collect live-saving blood for patients throughout our community during the summer months," said Martin Grable, president and CEO of CBCC. "High school students play a vital role in saving lives through blood donation in our community, so we wanted to find a way to recognize them and help them defray the cost of education in these challenging economic times." The Community Blood Center of the Carolinas is also donating up to $20,000 to its two other High School Scholarship Programs. One of the programs offers four $2,000 scholarships for students who exhibit leadership, service and teamwork through organizing high school blood drives during the school year. To qualify, students must be nominated by their high school coordinator and the high school must be a member of CBCC's High School Blood Drive Program. The drawing will be held at the end of the 20092010 school year. The top performing high school will also receive $2,000 donation. The other program guarantees a dedicated $500 scholarship for each school that commits to host a minimum of two blood drives a year and collects more than 100 pints of blood. The Community Blood Center of the Carolinas provides more than 90 percent of the blood supply to the 14 area hospitals that serve 11 North Carolina and three South Carolina counties. (Source: CBCC announcement, 12/8/09) The San Diego Blood Bank has relocated its East County Donor Center to a larger facility on Arnele Avenue in El Cajon, Calif. A grand opening celebration is planned for next Friday at 11 a.m., at the new facility, supported in part by Grossmont Healthcare District. Local residents will be invited to join community leaders and dignitaries for a ribbon cutting ceremony, tours of the facility, and refreshments. "The new center is very spacious and convenient to the freeway," said Ramona Walker, CEO of San Diego Blood Bank. The new center will offer all of the same services as the previous East County Donor Center: volunteer blood donations for area patients, the opportunity to give blood for one's own planned surgery and allow donors the ability to direct their donation to a specific patient in need of blood. In addition, the center will also routinely offer free bone marrow testing on site. The Blood Bank of Alaska is closing its donation centers in Wasilla and Soldotna in the face of a statewide downturn in blood demand. Spokesman David Large said that in the last five months, statewide demand has dropped by 10 percent. "With the increase in people losing their jobs, and with it their insurance, people are doing less elective surgeries," Mr. Large said. Lease agreements are set to expire at the end of the year for both the Wasilla branch, which contributes 7 percent of the state's donations, and the Soldotna branch, accounting for another 5 percent. "Despite the closing, hospital blood supply and availability will not be affected," the blood center said in a message on its Web site. "It is unfortunate that the current economic recession has required the organization to reduce operating expenses. We will continue to streamline our processes and provide a quality collection experience for all our donors." Blood Bank of Alaska services 25 healthcare facilities around the state. It has three other fixed donation centers -- two in Anchorage and one in Fairbanks. The group also uses mobile clinics to get donations from schools, businesses, or areas not near a fixed center.(Source: Blood Bank of Alaska Web site; Mat-Su Valley Frontiersman, 11/19/09)

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December 11, 2009

PEOPLE

Margie A. Gandolfi, vice president of Marketing and Strategic Planning at New York Blood Center (NYBC), will retire effective Dec. 31. Her term as treasurer for America's Blood Centers will also end at that time. "Margie has been a major contributor to the ABC leadership and a very loyal proponent of ABC for many years," said ABC CEO Jim MacPherson. "She will be sorely missed." Ms. Gandolfi has been in the blood community for over 30 years, starting as a public relations director for the Northeast Region of the American Red Cross in Boston and then as its director of Donor Resources. From there, she moved to Red Cross positions in California before joining NYBC, first as executive director of New York Blood Services and then rising through the ranks to her current position. She graduated from Boston University with degrees in journalism and marketing. She said she is "looking forward to exploring new opportunities."

MEETINGS

Dec. 15 Vaccines and Related Biological Products Advisory Committee Meeting, Center for Biologics Evaluation and Research, Bethesda, Md. Open session will include updates of the research programs in the Laboratory of Retroviruses, Laboratory of Immunoregulation, and Laboratory of Respiratory Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. From 4:15 to 5 p.m., interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Contact: Christine Walsh, RN. Phone: 301-827-0314. FAX: 301-827-0294. E-mail: [email protected] Feb. 19-20 3rd Annual Transfusion Medicine Conference, Children's Medical Center, Dallas, Texas The conference will provide current educational material for pediatric and non-pediatric transfusion medicine physicians, managers, supervisors, and technologists. Continuing education credit is available. Contact: Office of Continuing Education, University of Texas Southwestern. Phone: 214648-3138. Feb. 20-21 SBB "Last Chance" Review, Gulf Coast Regional Blood Center, Houston, Texas This program is designed for individuals preparing to take the ASCP SBB or BB Registry examination. Physicians who are preparing for the Board examination in Blood Banking and individuals wishing a refresher in blood banking can also benefit from this program. Details are available at www.giveblood.org/education/lastchance. Contact: Clare Wong. Phone: 713-791-6201. E-mail: [email protected] May 26-27 17th Workshop on "Surveillance and Screening of Blood Borne Pathogens," IPFA/PEI, Zagreb, Croatia Organized in collaboration with the Croatian Institute of Immunology. Details, registration information, and hotel information are available at www.ipfa.nl. Contact: IPFA Secretariat. Phone: 31-20-512-3561. E-mail: [email protected]

ABC Newsletter

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December 11, 2009

CLASSIFIED ADVERTISING

Classified advertisements, including notices of positions available & wanted, are published free of charge for a maximum of three weeks for ABC institutional members. There is a charge of $100 per placement for ABC Newsletter subscribers & $250 for non-subscribers. Notices ordinarily are limited to 150 words. To place an ad, contact Deanna Du Lac at the ABC office. Tel: (202) 654-2917; Fax: (202) 393-5527; E-mail: [email protected]

EQUIPMENT:

For Sale: Thermogenesis Plasma Freezer, Model MP1000, asking $500 plus the cost of crating and shipping HemataSTAT II MicroHematocrit Centrifuges, 19 instruments, asking $150 each plus shipping Donormatics (DM-S), 4 instruments, pay shipping costs If interested, E-mail Laurie McWilliams: [email protected]; Rock River Valley Blood Center, Rockford, Ill. HemataSTAT-II Microhematocrit Centrifuges. Central Illinois Community Blood Center has 19 HemataSTAT-II Microhematocrit Centrifuges for sale to the highest bidder. 1 was purchased in 1997 2 were purchased in 1998 5 were purchased in 1999 3 were purchased in 2000 3 were purchased in 2001 4 were purchased in 2003 2 were purchased in 2008 All are in working order. For more information, please E-mail Kathy Kirbach: [email protected]

POSITIONS AVAILABLE:

Transfusion Medicine Physician. American Red Cross Northeast Division seeks dynamic Transfusion Medicine Physician to assist Chief Medical Officers in: Directing medical aspects of blood center operations, including reference laboratories, transfusion medicine-related clinical services, medical community relations & research. Providing medical consultations on transfusion medicine issues & enhancing image of Red Cross as transfusion medicine leader regionally & nationally. M.D. or D.O. degree with minimum three years exp. in blood banking/transfusion medicine, or related field, or completion of blood banking/transfusion medicine fellowship req'd. Board certified in internal medicine, pediatrics or clinical pathology & board certified or eligible in blood banking/transfusion medicine req'd. Exp. in histocompatibility testing oversight highly desirable. Must be licensed or eligible for licensure in all states served by Division. Exp. in relevant medical/scientific research & scholarly activities sufficient to warrant academic appointment is highly desirable. Travel req'd. Salary commensurate with exp. To apply, please email resume to [email protected] Scientist/Laboratory Director, National Immunohematology Reference Laboratory (NIRL) ­ Head Office, Ottawa, Ontario. Canadian Blood Services is responsible for collection, testing & distribution of blood in all Canadian provinces, except Quebec. NIRL is responsible for providing reference immunohematology laboratory services to our three donor testing laboratories, our diagnostic laboratories & hospitals. We are looking for individual with expertise in red cell immunohematology to provide technical & scientific direction to NIRL & also to provide support to our donor testing & prenatal diagnostic laboratories. Evaluation & technical support for integration of various genotyping methods in blood donor, reference laboratory & prenatal settings would be key component of this position. Incumbent is expected to participate in CBS development projects, write reports, publish papers on regular basis & participate in training & supervising of CBS employees as req'd. Candidate will work closely with other CBS staff, in both our division of Medical, Scientific & Research Affairs & our Operations Division to develop policies & determine laboratory testing in various settings. Further possible responsibilities would be discussed with potential candidates, depending on their interests and abilities. Doctoral or medical

(continued on page 20)

ABC Newsletter POSITIONS (continued from page 19)

degree with specialization in appropriate area from recognized academic institution req'd. We offer competitive salary & opportunity to work with group of dedicated professionals. Please send your cover letter & resume quoting competition 09-109, to: [email protected] or alternately: Canadian Blood Services, Human Resources, 1800 Alta Vista Drive, Ottawa, ON K1G 4J5. Reference Laboratory Medical Technologist. Kentucky Blood Center in Lexington, KY seeks Reference Laboratory Medical Technologist to perform & interpret serological procedures on specimens submitted for compatibility testing or problem resolution. To resolve typing problems, antibody problems & crossmatch problems & communicate with hospitals as needed. This is 1st shift position working 8 am ­ 5 pm; Monday ­ Friday, including on call rotation. MT(ASCP) with minimum two years recent blood bank exp. & MT(ASCP) SBB pref'd. Strong written & oral communication skills, do-what-it-takes work ethic & team player attitude req'd. Benefits include: Medical Insurance, Life Insurance, Dental Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, Long Term Disability, 401K/403b Plan & Pension/Retirement. Screening Requirements: Drug Screen, Criminal Background Check. Drug free. EOE/AAP. For more information or to apply for this position, please visit us online at: www.kybloodcenter.org. Chief Executive Officer. American Red Cross seeks Chief Executive Officer (CEO) for Missouri-Illinois Blood Region. You will lead region-wide activities to accomplish goals & objectives for Blood Region. Develop & implement projects & plans to increase collection efficiency, increase total collections & to identify & exceed hospital customer requirements & expectations. Position will meet with sponsor groups & develop creative recruitment plans which consistently reflect system & patient needs. Bachelor's degree or equivalent exp. req'd. Master's degree pref'd. Minimum of ten years exp. in dynamic, multi-task operational environment with budget responsibility or profit & loss focus req'd. Candidates must be customer focused & demonstrate ability to attract, motivate & retain staff. Healthcare exp. pref'd. Occasional travel outside of region is necessary. To apply, visit: www.redcross.org/jobs, click on NHQ Opportunities & search for keyword 8090BR. EOE, M/F/D/V Supervisor, Clinical Lab (Blood Bank). Franklin Square Hospital Center, member of esteemed MedStar Health, is progressive facility providing comprehensive care to residents of our community. Located in White Marsh area of Baltimore, Franklin Square is third largest hospital in Maryland, with 380 beds & more than 3,000 employees. We're full-service, acute care teaching hospital & our team members are committed to providing our patients with highest quality healthcare possible.

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December 11, 2009

Right now, we're looking for: Supervisor, Clinical Lab (Blood Bank). Requirements: Three to five years exp. in Blood Bank, preferably in leadership position; Medical Technologist Blood Bank, (MTBB) req'd; Specialist Blood Bank (SSB) pref'd; Exp. & working knowledge in American Association of Blood Bank & FDA standards req'd. In return for your skills, we offer competitive salary & comprehensive benefits, along with FREE parking! To apply, visit us online at: www.franklinsquare.org. EOE Blood Collections Director Quality/Projects. Kentucky Blood Center, located in Lexington, Kentucky, seeks detail-oriented professional to oversee quality initiatives for Blood Collections & facilitate management/implementation of special projects. Responsibilities will include development, review & implementation of process improvement plans. Will coordinate quality improvement investigations, root cause analysis, and maintain direct communication with Quality Assurance department while developing & implementing corrective action plans. Will oversee regulatory compliance, SOP revision annual review process & error management reporting. Directs activities of Blood Collections QA/QC coordinator. Qualified applicants must have four-year degree, MT(ASCP). Three years exp. working in organization regulated by good manufacturing practice with FDA, AABB, CLIA & EU regulated exp. pref'd. Exp. with data analysis & equipment/process validation pref'd. Supervisory exp. pref'd. Must be proficient with MS Office products. Must be highly organized, reliable & have outstanding interpersonal skills. Strong written & oral communication skills, do-what-it-takes work ethic & team player attitude req'd. Competitive salary, comprehensive benefits including health/dental/life, LTD, paid vacations/holidays, EAP, 403(b) retirement savings plan & pension plan. For more information or to apply online please visit www.kybloodcenter.org. Drug free & EOE/AAP Reference Laboratory Technician. Kentucky Blood Center in Lexington, KY, seeks medical technologist to perform & interpret serological procedures on specimens submitted for compatibility testing or problem resolution. Will resolve typing problems, antibody problems, & cross match problems & communicate with hospitals as needed. 3rd shift, 10:30 p.m. - 7:00 a.m., Sunday - Thursday, including on-call rotation. This position requires MT (ASCP) with minimum two years recent blood bank exp., MT (ASCP) SBB pref'd. Strong written & oral communication skills, do-what-it-takes work ethic & team player attitude req'd. BS in Medical Technology (MT) or Clinical Laboratory Science (CLS). Competitive salary, comprehensive benefits including health/dental/life, LTD, paid vacations/holidays, EAP, 403(b) retirement savings plan & pension plan. Drug-

(continued on page 21)

ABC Newsletter POSITIONS (continued from page 20)

free and EOE/AAP. For more information or to apply for this position, please visit our website at: www.kybloodcenter.org. Laboratory Manager ­ Components. American Red Cross, Northern Ohio Blood Services Region, Cleveland, Ohio has opportunity to provide leadership & management to all aspects of Component Manufacturing, ensure coordination among departments for processing, storage & distribution of blood products to enhance operational success involving effective manufacturing & regulatory compliance. Coordinate installation of new or revised tests procedures in accordance with regulations. Bachelor's Degree in Science, Chemistry or Biology, MT (ASCP), SBB or exp. in blood banking pref'd. Or Bachelors Degree in Engineering & minimum of five years in pharmaceutical industry exp. in Process Engineering & Lean/Six Sigma principals considered. Five years manufacturing laboratory exp. req'd. Two years supervisory exp., good communication & computer skills req'd. Knowledge of pharmaceutical manufacturing processes pref'd. To apply E-mail resume & salary requirements to:

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December 11, 2009

[email protected] Excellent benefits include health, dental, vision insurance 401(k) & 403(b). If you have any questions, please contact TA at: (419) 3801142. Laboratory Scientist &/or ASCP Licensed Medical Technologist. Join San Diego Blood Bank Reference Laboratory & make difference in lives of patients, staff & community. Work in one of finest cities in America, sunny San Diego with mountains, beaches & average temperature of 75 degrees year round! SDBB is not-forprofit community blood center that provides blood services for region. SDBB offers ideal location to start career, opportunity to take on leadership roles & ability to grow within organization. We are looking for qualified candidates: California licensed or eligible Laboratory Scientist &/or ASCP Licensed Medical Technologist. Specialty in Blood Banking pref'd. Blood Bank/Immunohematology exp. (minimum three to five years) & willing to relocate. Work independently, trouble shoot, problem solve & accept responsibility. We offer generous paid time off program, 100% employee paid health benefits; pension plan & 403(b). For more information contact: Marci Swearingen: (619) 400-8320. AA/EOE

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