INSIDE: ABC Members Head to Arizona for ABC’s 50 Annual ...

2012 #7 February 17, 2012 ABC Members Head to Arizona for ABC’s 50th Annual Meeting

Employees of America’s Blood Centers’ members, along with regulatory, gov-ernment, and healthcare professionals, will convene to learn and share experiences about blood banking and transfusion medicine in sunny Scottsdale, Ariz., from March 24-27 at ABC’s 2012 Annual Meeting. This year is no ordinary Annual Meeting, however, as ABC will be celebrating its 50th anniversary with special events. ABC’s Annual Meeting provides ABC members and industry professionals with opportunities to learn from one another, share best practices, stay updated with advances in transfusion medicine, network, and of course – to have fun and socialize. This year, guests will enjoy a three-day 50th anniversary celebration, complete with dinners, cocktails, and dancing. Some of this year’s highlights include presentations from leaders in blood banking and transfusion medicine at the Scientific, Medical, and Technical (SMT) Forum as well as the “Navigating Through the Paradigm Shift” program and plenary session. Members will also vote on and welcome a new panel of board members and officers (see ABC Newsletter, 2/3/12), and will attend the Awards of Excel-lence & 50th Anniversary Reception & Banquet. On Tuesday, the ABC Government Affairs Committee will meet. Keynote Speaker. This year’s keynote speaker, Ian Morrison, is an international-ly known author, consultant, and futurist specializing in long-term forecasting and planning with particular emphasis on healthcare and the changing business envi-ronment. He has written, lectured, and consulted on a wide variety of forecasting, strategy, and healthcare topics for government, industry, and multiple non-profit organizations. Mr. Morrison has worked with more than 100 Fortune 500 compa-nies in healthcare, manufacturing, information technology, and financial services. He will give a talk titled “Healthcare is in the Eyes of the Beholder” on Monday, sponsored by Carter BloodCare and Indiana Blood Center. SMT Forum. Following the ABC Members meeting on Sunday morning, the SMT Forum will update attendees on various scientific advances in transfusion medicine. Members will hear an update on the AABB Donor Hemoglobin Suita-bility Interorganizational Task Force, and a discussion of a blood center’s experience with iron replacement for blood donors. Other topics of discussion

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INSIDE:

Our Space: Black Swan .. 2

AMA in Washington Seeking Final ‘Doc Fix’ Faced with Political Realities ........................ 4

Study: Transfusion and Chelation Remain Best Treatment for Sickle Cell Anemia Patients with Prior Stroke .................. 5

ABC Webinar Explores Cell Therapy Opportunities for Blood Center........................... 8

ABC Announces Save the Date for Next CTA Webinar ........................ 9

Save the Date: Links for Life Golf Tournament .... 9

Global Network for Blood Donation Seeks Board of Director Nominations .... 9

ABC: A Career Builder .. 10

BRIEFLY NOTED .......... 11

LEGISLATIVE NEWS ... 13

REGULATORY NEWS ...... ................................... 14

GLOBAL NEWS ............ 14

STOPLIGHT: Status of America’s Blood Centers’ Blood Supply 15

MEMBER NEWS ........... 16

PEOPLE ........................ 16

MEETINGS ................... 17

POSITIONS AVAILABLE ................................... 18

ABC Newsletter -2- February 17, 2012

OUR SPACE

ABC CEO Jim MacPherson

Black Swan

The metaphor behind the “black swan” goes back to Roman times when an impossibility was as likely as “see-ing a black swan.” More recently, Nassim Taleb in his groundbreaking 2007 book, Black Swan, states that just because we have never seen one, doesn’t mean a black swan cannot exist. Mr. Taleb persuasively argues that events of extreme impact that we never anticipated can and will continue to occur. While we tend to prepare for a recurrence of past disasters, Mr. Taleb argues that the unanticipated needs to be anticipated. His thinking is revolutionizing our approaches to risk- and crisis-management.

This doesn’t mean planning for all possibilities – that, by definition, is impossible. Instead, we need to accept that devastating outliers can and may be occurring, and we should look for creative solutions to address what appears to be happening. This is about suspending our disbelief when our emotions and instincts say “this is impossible.” Denial becomes our enemy.

In blood safety our black swan of historic proportions is the most devastating drug adulteration in medical history. Somewhere in the neighborhood of 30,000 transfusion recipients and 10,000 patients with hemophilia were infected with HIV in the early 1980s.

Since HIV, the blood community has faced multiple and varied “black swans” affecting blood safety, some that turned out to be real (like TRALI and West Nile virus), and others that turned out to be ghosts (like “white particulate matter” and more recently XMRV). In each case, there have been elements of denial, but looking back we took the threats seriously and looked for creative, albeit sometimes controversial, solutions while probing through the unknown. This is to our credit and is how such problems were meant to be solved. We’ve gotten pretty good in this area.

More recently the black swan has been the threat to our business model, that is, determining what a “commu-nity blood center” is as the healthcare system we serve changes. Eighteen months ago, the panic and denial was palpable. Today, we see creative solutions cropping up everywhere, from new alliances and consolida-tions to new business opportunities in cell therapies, blood production, and testing. More centers also are offering new services to hospitals, such as ABC’s Appropriate Inventory Management (AIM), centralized transfusion labs, and increased medical consultations.

This is all good. But be prepared – another black swan may be lurking around the corner.

[email protected] Visit Jim on Facebook: www.facebook.com/JimMacPhersonABC.

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 2012 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, and safety; and in finding efficiencies for the benefit of donors, patients, and healthcare facilities by encouraging collaboration among blood organizations and by acting as a forum for sharing information and best practices.

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Annual Meeting 2012 (continued from page 1) will include donor health screening, additive solution in platelets, and a summary of studies concerning RBC storage time. Obstetric hemorrhage and recent hot topics will also be covered. “Navigating Through the Paradigm Shift.” On Monday, attendees are invited to join healthcare profes-sionals, regulators, and government leaders as they present a futuristic view of challenges and opportunities facing the healthcare industry and the changing business environment. Blood center leaders will also offer their unique perspective, providing real-life experiences on managing change and seizing opportunities by broadening the scope of services as the standard business model. Attendees will hear a legislative advocacy update from employees at Patton Boggs LLP, Washington DC, as well as discussions about managing risk and adapting to change. A special guest will speak on Monday – retired Congressman John Shaddeg, of Arizona’s 3rd congres-sional district. Rep. Shadegg has served on the Subcommittee on Health of the House Committee on Energy and Commerce, and is also the son of Steve Shadegg, who managed Barry Goldwater’s 1952 and 1958 US Senate races. Social Events. ABC’s three-day anniversary celebration kicks off on Saturday evening with a mini-concert featuring pop songstress Jenni Alpert, followed by a cocktail reception and putting green competi-tion benefiting the Foundation for America’s Blood Centers. Ms. Alpert recently joined ABC’s speakers’ bureau “Conversations About Life” after embarking on her “Blood Driven” tour last summer. She cov-ered more than 5,000 miles of the West Coast performing and speaking at blood drives, blood centers, children’s hospitals, and local venues to promote blood donation. She has sung with artists such as Sara Bareilles and Regina Spektor, and her music has been featured on numerous TV shows. After a day of informative SMT sessions on Sunday, guests can cut loose at an evening of cocktails, din-ner, and dancing to be held at the Westin-Kierland Resort & Spa, hosted by Blood Systems. The CBBC Supper Club ’62 will have a 1960s-inspired theme to commemorate the formation of the Community Blood Bank Council (CBBC), forerunner of today’s ABC, in 1962. Then on Monday, the Awards of Ex-cellence and the 50th Anniversary Banquet at the Scottsdale Plaza Resort Grande Ballroom will offer guests the opportunity to honor influential and supportive individuals and organizations in blood banking (see ABC Newsletter, 2/3/12). Guests can also take a trip down memory lane, complete with a photo-graphic timeline exhibit and video commemorating the last half century of blood banking. Pre- and Post-Annual Meeting Events. Other meetings (by additional invitation only) include board meetings of: ABC, BCx, BGA, the FABC, and GSABC. Attendees must reserve a hotel room by Feb. 20 and register by March 2. More details and the full agenda are available by following the link provided in the event invitations emailed by ABC. If you did not re-ceive an invitation or have other questions, please contact Lori Beaston at [email protected].

We Welcome Your Letters

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


AMA in Washington Seeking Final ‘Doc Fix’ Faced with Political Realities The American Medical Association (AMA) held its National Advocacy Conference in Washington, D.C., this week to deliver a familiar message: Congress must “permanently fix” the sustainable growth rate (SGR) formula to make federal payments to physicians more equitable. But during conference presenta-tions, another, blunter, sentiment emerged: Get real – this is an election year. Right on cue, a House-Senate conference committee reached a tentative agreement the same night to ex-tend unemployment benefits and a 2 percentage point payroll tax break, while delaying a 27.4-percent Medicare physician payment cut – but only until the end of the year. AMA advocacy actually began Monday when a couple hundred medical students – facing the dual pros-pect of skyrocketing school debt and reduced Medicare payments – converged on Capitol Hill for the organization’s student lobbying day. On Tuesday and Wednesday, a similarly large group of physicians gathered in the well-appointed Grand Hyatt to prepare for their own meetings on the Hill later in the week. They heard a mix of upbeat presentations on the status of delivery system reforms in the public and private sectors, and generally gloomy presentations on the role of healthcare in budget negotiations in Congress. The cut in Medicare physician reimbursement rates was due to take effect Jan. 1, but Congress voted in late December to extend the deadline to March 1. More than one speaker pointed out that, during an elec-tion year, Congress would be loathe to pass anything more than another temporary measure to put off the painful decision of how much permanent SGR should impact beneficiaries and taxpayers. But expect a “train wreck” during the post-election lame duck session, no matter which party prevails in November, said G. William Hoagland, vice president for Federal Affairs at Cigna, and a former Senate Budget Committee staffer who worked for former Sens. Pete Domenici (R-NM) and Bill Frist (R-Tenn.). Using charts and graphs, Mr. Hoagland explained where money is being spent and the dwindling options available to Congress as it attempts to reduce the federal deficit. The “bad news,” he said, is that, as a percentage of gross domestic product (GDP), healthcare is the big-gest driver of spending. Considering that Medicare and Medicaid together represent about a quarter of the budget, and Social Security represents another quarter, healthcare entitlements will most likely see re-forms first followed by Social Security. Mr. Hoagland called the Obama administration’s budget proposal for fiscal year 2013 (which begins Oct. 1), “more of a presidential campaign document than a blueprint for going forward.” He said the plan is full of rosy predictions. “Mr. Obama believes revenue will grow at a 9.7 percent rate. The last time we had that rate of growth was in the years 1995 to 2000.” And Mr. Hoagland said that while many believe the Bush administration tax cuts are bound to expire, there is a “bipartisan consensus” for extending the tax cuts for families making less than $250,000 annual-ly. Sheila Burke, who served as chief of staff for former Sen. Robert Dole (R-Kans.) and is a former staffer of the Senate Finance Committee, agreed that 2013 will be “the year of tax reform,” stressing that neither entitlement cuts nor tax increases alone will get the budget deficit under control. It will be a complicated mess, she said, full of winners and losers. Asked about the chances for a simple flat-tax reform, she said “one man’s complexity is another man’s home mortgage deduction.”



AMA Advocacy Conference (continued from page 4) Ms. Burke said that Medicare may likely transition from a “guaranteed benefit” to a “fixed premium where you give people the option of shopping for what they want.” She said that, historically, tax policy has been used to encourage or discourage certain behaviors, and predicted that will happen again. Medi-caid is also in flux, despite healthcare reforms aimed at expanding the base of beneficiaries. Earlier in the morning, Chris Dawe, director of Delivery System Reform at the Department of Health and Human Services spoke on what was in the pipeline to make value-based care a reality. He was followed by two officials from major health insurance carriers, who discussed new payment delivery models. One that has been developing since 2006 is called the “Blue Distinction Centers,” a designation that Blue Cross Blue Shield gives to facilities that provide treatments focused around a particular specialty – such as hip and knee surgery, or cardiac care – and that meet certain quality and cost metrics. If that sounds a lot like Accountable Care Organizations (ACO), it is no coincidence. Health insurance reps talked about “value based care” and the need to “engage patients in health living practices” – two concepts right out of the ACO playbook. Mary Tavenner, acting administrator and chief operating officer of the Centers for Medicare and Medica-id Services, delivered the keynote address on Tuesday.

– Robert Kapler, [email protected] Study: Transfusion and Chelation Remain Best Treatment for Sickle Cell Anemia Patients with Prior Stroke Researchers recently found that blood transfusions combined with chelation is still the better way to treat children with sickle cell anemia (SCA) who have had a stroke and iron overload, when compared to treatment with hydroxyurea, a drug that has been studied as an alternative to blood transfusions in treating SCA. Russell E. Ware, MD, PhD, of Baylor College of Medicine and Texas Children’s Hospital, and colleagues conducted the Stroke With Transfusions Changing to Hydroxyurea (SWiTCH) trial, supported by the National Heart, Lung, and Blood Institute. NHLBI ended SWiTCH after interim analysis, finding that there was no significant difference in iron level between the two treatment groups. The results were pub-lished online on Feb. 7 in Blood. Background. People with sickle cell disease have an abnormal type of hemoglobin (HbS,) because they inherited two copies of an altered gene. Under certain circumstances, HbS causes red blood cells (RBCs) to assume crescent shapes and become more “sticky.” The misshapen RBCs then get stuck in small blood vessels and interrupt blood flow, causing organ and tissue damage, pain, and sometimes stroke. Fetal hemoglobin (HbF) has been shown to lessen the severity of sickle cell disease, but the body no longer produces it after birth. Frequent RBC transfusion is the most widely used treatment to manage SCA, because it raises the hemog-lobin levels, reduces the proportion of circulating HbS, and improves blood flow. Chronic transfusion, however, can cause iron overload, which must be managed with chelation therapy. Chelation therapy involves injecting a type of medicine that binds to metals, such as iron, to remove them from the



Sickle Cell Treatment (continued from page 5) body. Recent clinical trials have shown that hydroxyurea can be used to manage SCA and prevent recur-rent SCA-associated stroke. Hydroxyurea promotes the production of fetal hemoglobin, and could possibly reduce the need for transfusions and iron overload. Methods. SWiTCH was a multicenter Phase III randomized trial comparing standard treatment (transfu-sion/chelation) to alternative treatment (hydroxyurea/phlebotomy) for children with SCA, stroke, and iron overload. SWiTCH was a non-inferiority trial with a composite primary endpoint, allowing an increased stroke within certain limits, but requiring that hydroxyurea with phlebotomy show superiority for remov-ing iron. Therapeutic phlebotomy can reduce the iron burden in these patients. SCA patients with previous stroke and 18 months or more of transfusion with documented iron overload were recruited from 26 pediatric sickle cell programs. The participants were randomized to either the standard or alternative treatment group. The researchers set separate acceptable recurrent stroke rates for each group, with the recurrent stroke rate predicted to be 0.06 in the standard treatment group and 0.12 in the alternative treatment group. This “ac-ceptable” stroke margin was offset by the likelihood of improved iron overload management through serial phlebotomy in conjunction with hydroxyurea treatment, compared to chelation in conjunction with transfusion. Secondary endpoints included non-stroke neurological events, non-neurological sickle cell clinical events, quality of life, and measures of organ function. Patients in the standard treatment group continued monthly blood transfusions designed to maintain a target of 30 percent or less HbS and received daily iron chelation. Patients in the alternative treatment group began hydroxyurea at 20 mg/kg per day with step-wise escalation to the maximum tolerated dose (MTD). Transfusion continued for 4-9 months while the patient transitioned to hydroxyurea treatment. Once MTD was reached, transfusions were discontinued and phlebotomy commenced with a target of 10 mL/kg of blood removed monthly to reduce iron burden. Through evaluation by neurologists and radiological tests, patients were diagnosed with recurrent stroke (part of the primary study endpoint) if new neurological clinical findings and corresponding radiological changes were observed. Patients were diagnosed with transient ischemic attack (TIA) if new neurological findings but no corresponding radiological changes were observed. Results. A total of 202 children with SCA and stroke were screened, with 161 consenting to SWiTCH. After screening, 134 remained eligible for the trial and one subject moved before the trial began, leaving 133 patients (66 in the standard treatment group and 67 in the alternative treatment group). Most patients in the standard treatment group received simple transfusion, and the average HbS level was about 30 percent. Of the 67 patients in the alternative treatment group, 90 percent reached MTD and had transfusions discontinued. On hydroxyurea, the average hemoglobin concentration remained stable at around 9 gm/dL, with expected significant increases in MCV, MCH, and percent of HbF. The final aver-age HbF was 19.5 percent, and serum ferritin was significantly lower on the alternative treatment group. During the hydroxyurea dose escalation, a mean of 8 ± 3 monthly transfusions was given, and after MTD was reached, phlebotomy had to be reduced at least once for 36 patients due to issues such as low hemog-lobin.



Sickle Cell Treatment (continued from page 6) Seven patients, all in the alternative treatment group, had a stroke, while none in the standard treatment group had a stroke. Considering all severe events (stroke, TIA, and death) together, the two treatment groups were similar with 10 subjects affected in the standard group and 12 in the alternative group. The difference in stroke rate was still within the study’s set margin, but after the first scheduled interim analy-sis the researchers found that the liver iron content values were not significantly different between the two groups (16.6 mg/gm dry weight liver in the standard group compared to 15.7 mg/gm in the alternative group). Therefore, NHLBI closed SWiTCH. Conclusions. By the interim analysis, both groups maintained the targeted laboratory goals. Patients treated with transfusions and chelation maintained an average of 30 percent HbS, and alternative treat-ment patients who reached MTD had 29.1 ± 6.7 percent HbF. While both groups reached their prospective laboratory goals, there was a significant imbalance of strokes between treatments arms, and the LIC values were essentially unchanged throughout the study. There are a few possible reasons for the unchanged iron levels observed in both groups, including that patients in the standard treatment group complied better with the chelation regiment than predicted, and the overlap period when patients received both transfusion and hydroxyurea may have increased the iron burden for those patients, wrote the researchers. “Based on SWiTCH trial results, transfusion and chelation remain the better way to manage children with SCA, stroke, and iron overload,” concluded the authors. They noted that in a future study hydroxyurea will be compared to transfusions for children with abnormally elevated TCD velocities but no primary stroke, in the TCD With Transfusions Changing Hydroxyurea (TWiTCH) trial. Citation: Ware RE, Helms RW, et al. Stroke with transfusions changing to hyroxyurea (SWiTCH). Blood. 2012 Feb. 7. [Epub ahead of print].

ABC’s Golden Anniversary

Three-Day Celebration Event

ABC is turning 50 and we’re having a ball ... and you’re invited! Save the date: March 24-26, 2012, Scottsdale, Ariz., hosted by Blood Systems, Inc., in connection with ABC’s Annual Meeting. Online registration is now open! If you did not receive an e-mail invite with registration information, please contact [email protected] with the subject line: “ABC Golden Anniversary Invitation.” Have a good memory? Been around blood for a while? The Newsletter will be featuring a series of stories detailing the last 50 years in blood banking. To contribute your story, e-mail [email protected].

Save the Date for a 3-Day celebration event commemorating america’s blood centers’ 50th anniversary at the abc annual Meeting, Scottsdale, arizona

Odes to the 50thJenni Alpert mini-concert, cocktail reception and putting green competition benefiting the Foundation for America’s Blood Centers. Co-hosted by

Emerging pop songstress Jenni Alpert has a powerful sultry voice whose honest rich songwriting and soothing musical melodies grab listeners in every corner. Recently Jenni joined ABC’s speakers’ bureau “Conversations About Life” after embarking on her “Blood Driven” tour last summer where she covered over 5,000 miles of the West Coast performing and speaking at blood drives, blood centers, children’s hospitals and local venues to raise awareness on blood donation. Jenni has performed live with artists such as Sara Bareilles, Jon Allen, and Regina Spektor. Her music has been featured on TV shows such as Castle, CSI Miami, Lipstick Jungle, and MTV’s The Real World. Jenni’s mini-concert will kick off the celebrations, followed by an outdoor cocktail reception and a putting green competition available to anyone wishing to enter. Proceeds from the putting green competition will benefit the Foundation for America’s Blood Centers.Location: Scottsdale Plaza Resort Cypress Court (outdoor space), 5 to 7 p.m.

The cbbc Supper club ’62Hosted by

Where were you in ’62? Lawrence of Arabia was best picture, we loved Lucy on TV, Walter Cronkite was the new anchor for the CBS Evening News, we rocked to The Twist, and To Kill a Mockingbird was on the nightstand. Imagine yourself in that Camelot year at the founding of CBBC, Community Blood Bank Council, forerunner of today’s America’s Blood Centers. Join our host (and one of ABC’s founders) Blood Systems for an evening of cocktails, dinner and dancing at The cbbc Supper club ’62. Attire is business casual, early ’60s vintage or inspired by the era. Location: The Westin Kierland Resort & Spa (bus transportation provided), 5:30 to 10 p.m.

MEMBER OWNED. MEMBER DRIVEN.

The Foundation ForAmerica’s Blood Centers

Saturday, March 24

Sunday, March 25

Monday, March 26

Awards of Excellence and 50th Anniversary Banquet

Begin the evening with a trip down memory lane, complete with a photographic timeline exhibit and video commemorating the last half century of blood banking, followed by the Awards of Excellence and 50th Anniversary Banquet. We will recognize individuals and organizations that have a long-standing record of support and collaboration with ABC, its members and the blood banking community. Join us for cocktails, dinner, and reminiscing as we close our 3-day celebration by honoring ABC and FABC award recipients. Business attire.Location: Scottsdale Plaza Resort Grande Ballroom, 6 to 9 p.m.

To receive an invite, email [email protected] with the subject line “ABC Golden Anniversary Invitation.”


ABC Webinar Explores Cell Therapy Opportunities for Blood Center

America’s Blood Centers hosted a webinar last week in which R. Lee Buckler, BEd, LLB, founder and managing director of the Cell Therapy Group, detailed the opportunities for blood centers in cell therapy. Mr. Buckler’s webinar was the second in a series of free and open webinars by the Cellular Therapy Al-liance (CTA), the first international business alliance of not-for-profit organizations focused on cell therapies (see ABC Newsletter, 1/6/12). Mr. Buckler is a blogger, analyst, facilitator and connector, consultant, and entrepreneur in the cellular therapy arena. The Cell Therapy Group is a consultancy focused on the cell therapy and regenerative medicine industry. He began his presentation with an overview of current Food and Drug Administration approved therapies and the companies that provide such products, showing an enormous growth in the cellular therapies industry. He also reviewed current clinical trials in cellular therapy, highlighting that interest in this area continues to grow with more and more products in development. Mr. Buckler said that the cellular therapy scene has changed dramatically over the last 10 years as the commercial value of cell therapies continues to increase and many more stakeholders emerge, including the government and various pharma, life-science, and medical device companies. This growth has not, however, been limited to commercial industries, as the cell therapy business at independent blood centers grew from “almost nothing” to about 2,000 collections in about 35 sites generating $3 million in revenues in 2011, said Mr. Buckler. The growth at independent blood centers has been exclusively from patient-donor collections, said Mr. Buckler, but there are other opportunities such as custom allogeneic collections, post-collection minimal manipulation cell processing, collection from cell sources such as cord blood or bone marrow, and stem cell or tissue banking. He explained that independent blood centers in the US also have several advantages in the cellular thera-py arena, because these blood centers represent a cohesive, independent network. For example, the community blood center network in the US represents one of the largest single networks of collection centers in the world and offers employees that are accustomed to working in a strictly regulated environ-ment. However, there are other competitors such as academic centers, the American Red Cross, and various companies. He emphasized that working with a single entity to provide cellular therapy services, rather than several centers, will be easiest for customers. Mr. Buckler concluded that cohesion is one of the most important keys to success for blood centers look-ing to expand their cellular therapy services. A centralized administration and access will be easiest for customers. He emphasized that it is important for blood centers to offer companies “one stop shopping” for their cell therapy needs, reinforcing the need for group selling. Blood centers interested in cellular therapy must also demonstrate a commitment to being commercially flexible and service-oriented, and must participate in the field’s leadership and executive network, said Mr. Buckler. The CTA, launched in January by ABC, the European Blood Alliance, and the National Marrow Donor Program, will be hosting another webinar that is free and open to the public on March 2 (see following


INSIDE ABC


INSIDE ABC (continued from page 8) Article for details). To access Mr. Buckler’s webinar slides, please contact Miriam Bolaños [email protected].

ABC Announces Save the Date for Next CTA Webinar The Cellular Therapy Alliance (CTA) will be hosting another webinar that is free and open to the public, titled “How Private Insurance Companies Determine When to Reimburse for ‘Experimental Therapies,’” on March 12 at 12 p.m. EDT. Dennis Irwin, MD, the national medical director for Complex Medical Conditions at Optum Health, a division of United Health Group, will be giving the presentation. Dr. Irwin will discuss how reimbursement, or more precisely, the lack of it, can be an impediment to the wider use of new and promising cell therapies. He will explain how insurance works in such areas, in-cluding the process that health insurers use to determine insurance coverage when a new and experimental therapy shows promise, as well as what researchers and involved companies should know and do to assure that insurers are aware of new therapies’ benefits. Dr. Irwin’s major interest is in improving outcomes and managing costs in catastrophic illness. He is a nationally recognized case management expert on complex care, especially transplant and stem cell thera-pies. This is the third in a series of free webinars by the CTA, launched in January by ABC, the European Blood Alliance, and the National Marrow Donor Program. The CTA is the first international business alliance of not-for-profit organizations focused on cell therapies (see ABC Newsletter, 1/6/12). To view the webinar, participants must follow this link: http://bit.ly/wXgl4R. The meeting number is 597 786 018, and does not require a password. To listen to the audio, participants in the US and Canada must dial 707-287-9570, using the conference code 202 654 2902. Those dialing in from outside the US or Canada can view global numbers at: http://bit.ly/AhgWXe. For meeting visual technical support, please call 1-877-812-5401 or 1-706-643-6127.

Save the Date: Links for Life Golf Tournament The Foundation for America’s Blood Centers (FABC) has recently announced that the third annual Links for Life Golf Tournament to benefit the FABC will be held on Oct. 22 at the Champions Retreat golf course in Evans, Ga. This year’s tournament will be hosted by HemoCue and Shepeard Commu-nity Blood Center. The Champions Retreat has been ranked as one of the best clubs in the world in “Rolex World’s Top 1,000 Courses 2010.” More details about Links for Life will be forthcoming. More information about past Links for Golf Tournaments is available at: www.thefabc.org/events_links.html.

Global Network for Blood Donation Seeks Board of Director Nominations The Nominations Committee is seeking members for the Global Network for Blood Donation who wish to be considered for a seat on the Board of Directors. The Global Network for Blood Donation is a Rotarian Action Group. The group seeks individuals for the Board who are actively involved in pro-moting volunteer blood donation in their communities and within Rotary clubs, and leaders who will take an active role in developing and promoting the Global Network for Blood Donation. Applications must be received by March 31. More information is available at: www.ourblooddrive.org.


ABC: A Career Builder By: Bill Coenen, CFO, ABC [Editor’s Note: The ABC Newsletter has requested that readers send in their blood banking stories from the last 50 years as ABC prepares to celebrate its 50th anniversary during the 2012 ABC Annual Meeting in Scottsdale Ariz., this March.] My term as president of America’s Blood Centers was at a great time, but before I get to those two years, I would like to take you back to my first ABC (then Council of Community Blood Centers) meeting in February 1976. The organization was a lot smaller then, and in fact, that members meeting consisted of 15 to 20 people sitting around a board table in a very small room. For me, sitting with these icons of the time was a major experience. I think I was so intimidated that I didn’t say a word, as hard as that may be to believe. Outside of being very impressed, there was a downside to that meeting. While these icons con-ducted important business, they were smoking cigarettes, cigars, and pipes. Being a non-smoker in this poorly ventilated room, I thought this would be my last meeting since surely I would die from lack of fresh air to breathe. Somehow, I did survive that day. Thus began a long and very rewarding career with ABC encompassing involvement as an employee of a member organization, to volunteer, to employee of ABC, and most likely ending again as a volunteer. My term as president, beginning in April 1993, was relatively quiet compared to what came before and after. It was a time of growth for ABC, as independent blood centers were looking for a voice on the national scene. ABC was deep in providing education to help members adjust to the paradigm shift in the regulatory environment with the movement to current Good Manufacturing Practices (cGMPs). Competi-tion, although on the horizon, had not really reared its ugly head yet. The biggest issue was the Hillary Clinton healthcare reform. I spent most of my two years traveling to Washington DC, sometimes twice a week, meeting with congressional members, aides, and even appearing at congressional hearings to try and assure that independent blood center needs were incorporated in any final document. One of the most significant events was appearing in front of a congressional hearing chaired by Senator Tom Harkin (D-Iowa). Television cameras were set-up, lights on, and committee members ready. I thought, growing up in Iowa myself, that this would be televised in Iowa and my parents would see me in action, only to see Miss Iowa appear, receive an award from Senator Harkin and disappear along with the cameras leaving me with Senator Harkin and the committee. Claim to fame can be fleeting. And there was the time when Kathryn Zoon, director of the Food and Drug Administration’s Center for Biologics Evalu-ation and Research (CBER) called me on her way home from work to see if ABC would support user fees. We later met and began the discussions, which still continue today, on how CBER could improve the turn-around time for product licensure. On my trips to DC, I stayed at and enjoyed the hospitality of “B&B Jim MacPherson,” where I was al-ways greeted in the morning with a hearty breakfast and a free commute to the ABC office. As I reflect back on those days, they were a great experience. ABC provided the tools to help me grow in my career, which helped me better serve my local community, and also provided me with the opportunity to impact blood banking on a national level. I always thought, and still do today, “Where else could this kid from Iowa have had the chance to experience all this?”


BRIEFLY NOTED A doctor presenting research at the American Academy of Orthopedic Surgeons in San Francisco on Feb. 7 said that platelet rich plasma (PRP) may be beneficial in treating patients with severe chronic plantar fasciitis, reported HealthDay News. Plantar fasciitis is a painful inflammatory process of the connective tissue on the sole of the foot, often caused by overuse of the plantar fascia tissue or arch tendon of the foot. Raymond R. Mont, MD, from the Nantucket Cottage Hospital in Massachusetts pre-sented a study in which the researchers compared PRP with cortisone injections for the treatment of 36 patients with plantar fasciitis that was resistant to traditional non-operative management. Patients under-went pretreatment MRI and ultrasound studies. Group 1 was treated with a single ultrasound-guided injection of 40 mg methylprednisolone (cortisone) at the injury site, and Group 2 was treated with a single ultrasound-guided injection of un-buffered autologous PRP at the injury site. All patients then used a walker for two weeks, started on eccentric home exercises, and then were allowed to return to normal activities as tolerated and without support, said the abstract. Group 1 had an average of 5.4 months of failed standard non-operative treatment, and an average pretreatment American Orthopedic Foot & Ankle Society (AOFAS) score of 52. Group 2 had an average of 5.7 months of failed standard non-operative treatment, and an average pretreatment AOFAS score of 37. Dr. Monto found that in Group 1, the average post-treatment AOFAS score improved to 81 at three months, and decreased to 74 at six months, then decreased to 58 at 12 months. In Group 2 (PRP group), the average post-treatment AOFAS score im-proved to 95 at three months, and remained at 94 six and 12 months after treatment. “This study suggests that platelet rich plasma injection is significantly more effective and durable than cortisone injection for the treatment of severe chronic plantar fasciitis refractory to traditional non-operative management,” wrote Dr. Mont in the abstract. In a PRP treatment, doctors take the patient’s own platelets and then inject them into the injured area, hoping that they will heal the tissue. Several famous athletes, such as Tiger Woods, Kobe Bryant, and Los Angeles Dodgers pitcher Takashi Saito, have recently popularized such treatments by publishing what they believe to have been successful PRP treatments for various injuries. Despite the growing commercial interest in PRP treatments, there is conflicting evidence as to whether the treatments actually cause injuries to heal, or whether rest and exercise prescribed in conjunction with the treatment are what actually heal the injuries. America’s Blood Centers recently published a Blood Bulletin on this topic, which is available at: www.americasblood.org/go.cfm?do=Page.View&pid=74. (Source: HealthDay News, 2/7/12; American Academy of Orthopedic Surgeons Annual Meeting Abstract 051, 2/7/12) The National Heart, Lung, and Blood Institute (NHLBI) recently posted on its website a summary of 36 key research findings in fiscal year 2011, several of which deal with blood disease. One hig-hlighted study, called BABY HUG, showed that hydroxyurea, a successful treatment for sickle cell disease in human adults is also safe and effective for 8- to 9- month-old children. The drug was found to reduce the frequency of pain episodes and acute chest syndrome, and also to improve spleen and kidney function and lower the risk of swelling in the hands and feet. Children on hydroxyurea in this study re-quired less transfusions and were hospitalized less often. A recent study, however, has found that blood transfusion combined with chelation therapy is still the preferred treatment in children with sickle cell disease who have already had a stroke and have iron overload (see story on page 5). Another NHLBI highlighted study on treatments for aplastic anemia showed that ATGAM (the only approved treatment in the US) is more effective than Thymoglobin, a similar treatment used abroad. In another study, research-ers identified mutations in 18 genes that were linked to clinical outcomes in people with blood disorders known as myelodysplastic syndromes. This discovery could help doctors choose the right treatments and better predict how the patients will fare. Support from NHLBI also allowed researchers to observe trans-planted hematopoietic stem cells inside a thin skull bone in mice in real-time. The NHLBI summary also discussed the September 2011 study that put the final nail in the coffin of the now-retracted Science



BRIEFLY NOTED (continued from page 11) paper that originally linked chronic fatigue syndrome to the xenotropic murine leukemia virus-related virus (XMRV). The complete NHLBI summary is available at: www.nhlbi.nih.gov/new/fiscalyear11.htm. (Source: NHBLI summary of findings in fiscal year 2011, 2/13/12) Research presented in an abstract at the American Academy of Orthopedic Surgeons 2012 Annual Meeting on Feb. 9 has shown that mesenchymal stem cells (MSC) may speed the healing process when injected into knee joints following surgery, reported MedPage Today. The randomized phase I/II double blind clinical trial was presented by lead researcher C.T. Vangness, Jr., MD, of the University of Southern California in Los Angeles. The researchers sought to evaluate the safety and efficacy of MSC injections on meniscus regeneration and osteoarthritis progression after knee surgery. Fifty-five patients with meniscal tears scheduled for surgical resection were randomized to one of three single dose injection groups: low MSC dose (50 million cells), high MSC dose (150 million cells), and a hyaluronic acid (HA) placebo. The patients were examined for pain response and had MRI scans of the resected knee periodi-cally for up to two years afterwards. All but three patients stayed in the study for the full two years. Patients with osteoarthritis receiving MSCs experienced a significant pain reduction compared to those receiving the placebo. Patients receiving the placebo were 3.5 times more likely to experience degenera-tive bone change associated with osteoarthritis compared to those receiving MSCs. Subchondral sclerosis and osteophyte formation were reported in 21 percent of patients receiving the control, but only in 6 per-cent of MSC treated patients. No serious adverse events were seen at the two-year follow-up. MRI meniscus volume growth by digital analysis showed wide variability and no statistically significant im-provement. Researchers said that the most important finding is that the treatment appears safe, and noted that in future studies the pain endpoint may become the primary efficacy outcome. The complete abstract is available at: http://bit.ly/AlgIX4. (Source: MedPage Today, 2/10/12; American Academy of Orthopedic Surgeons 2012 Annual Meeting Abstract #552)

NEW FOR 2012

Advertise in the ABC Newsletter and reach key decision makers in blood banking and transfusion medicine. Published 46 to 48 times a year, the ABC Newsletter is a weekly chronicle of current events and issues affecting the blood banking and transfusion medicine communities. Editorial coverage includes regulation, legislation, litigation, science, technology, and new developments in blood services. Special sections highlight ABC member news and updates from ABC headquarters. A comprehensive calendar of events is published once a month and there is a classified advertising section for employment opportunities, equipment, and other notices. Circulation: approximately 5,000; email only, <0.5% bounce back rate (subscription based) Frequency: weekly, 46 to 48 issues per year on Fridays (unless Friday is a holiday, then Thursday) Length and format: Up to 22 pages; portable document format (PDF), portrait layout, 8.5 by 11”

The ABC Newsletter accepts full-page, half-page, third-page, and Marketplace (ninth-page) ads. Reserve early to guarantee space (ad space is limited). For rates and ad placement forms, download the 2012 Advertising Opportunities info at http://bit.ly/opps2012 (see p. 9-10 & 13).


LEGISLATIVE NEWS A spokesman for the medical device industry testified before a House subcommittee on Wednesday in support of a tentative agreement to reauthorize the five-year Medical Device User Fee Act (MDUFA), set to expire at the end of September. David Perez, president and CEO of Terumo BCT and

a member of the AdvaMed board of directors’ executive committee as well as the Foundation for America’s Blood Centers’ board, told the Energy and Commerce Committee’s Subcommittee on Health that the deal “is a huge step in the right direc-tion.” The agreement, he said, substantively addresses two regulatory problems that have been derailing innovation in recent years: delays in Food and Drug Administra-tion device review decisions and inconsistencies in its review process. He said the total time from submission to final decision increased 43 percent from the average time during the years 2003 to 2007 and 2010. The “resulting downstream effects on investment and innovation have undermined the competitiveness of our industry and harmed patient access to new treatments, diagnostics, and cures,” he said. The

agreement establishes total real time goals for FDA product review and improves time goals when the FDA review clock is running. Process improvements include more pre-submission interactions between FDA and applicants, a meeting midway through the review process, and a “no submission left behind” policy designed to enable both parties to resolve outstanding issues. The MDUFA III deal also requires the agency to submit quarterly and annual reports on key metrics and track new agreed upon performance indicators. An independent consulting organization will also analyze the review process and FDA’s cor-rective action plan. In return, device makers will provide $595 million in user fees from 2013 to 2017, allowing the agency to hire 200 additional FTEs. Mr. Perez was one of eight members of a witness panel to testify on Wednesday, including representatives of two patient groups. His remarks came directly after a two-hour grilling by committee members of Jeffrey Shuren, MD, director of the Center for Devices and Radiological Health. Dr. Shuren also praised the agreement but defended his agency’s device review record, saying that an increase in the percentage of 510(k) “substantially equivalent” submissions requir-ing an “additional information letter” after the first review cycle has contributed greatly to the increase in time to make decisions. Most Republican members were unappeased by his defense of MDUFA II, won-dered about FDA’s resource allocations, and questioned its efforts to harmonize review procedures and data submissions with those of FDA’s European counterparts. The common perception in the industry is that European regulatory bodies come to decisions more quickly and with less fuss than the FDA. Dr. Shuren talked about the work of the Global Harmonization Task Force and said the agency was plagued with doubts about whether “we could actually rely on the data submitted or the decisions made by other regulatory bodies.” Members also took the opportunity to tout a handful of legislative bills aimed at im-proving the FDA device review process, including 510(k) device reviews.

– Robert Kapler, [email protected] The Obama administration unveiled a $3.8 trillion budget plan for fiscal year 2013 on Monday that envisions $4 trillion in deficit reductions over the next decade, based in large part on sunny growth predictions, higher taxes on the rich, the removal of some corporate tax breaks, and cuts to health-care providers. Given that this is a general election year, the plan sidesteps imposing draconian cuts to Medicare or Medicaid beneficiaries. Still, the spending plan calls for cutting Medicare by $268 billion and Medicaid by $52 billion over 10 years, mainly through reduced payments to healthcare providers. According to an analysis by the American Hospital Association (AHA), the plan would reduce Medicare payments for bad debt (when beneficiaries cannot pay their share of healthcare costs), cut indirect gradu-ate medical education by 10 percent, and reduce payment updates for post-acute providers. Starting in FY 2013, the proposal would reduce critical access hospital payments from 101 percent to 100 percent of reasonable costs and eliminate the critical access hospital designation for facilities less than 10 miles



LEGISLATIVE NEWS (continued from page 13) from the nearest hospital. Medicaid-related proposals include limiting provider taxes beginning in 2015; replacing the current payment formulas with a single matching rate specific to each state; and rebasing disproportionate share payments for hospitals in 2021. “Today’s budget is bad news for our nation's se-niors and most vulnerable citizens,” said AHA President and CEO Rich Umbdenstock. “It once again targets funding for hospital care and could result in fewer nurses, less access to cutting-edge treatments and longer waits for emergency care.” The budget projects Medicare spending will double from $478 billion this year to almost $1 trillion in 2022. Medicaid spending would more than double from $255 billion this year to $589 billion by 2022. The $3.8 trillion in spending next year is an increase of 0.2 percent over this year’s expected outlays and relies on a 17.5 percent increase in revenues. Deficits are projected to gradually decrease to $575 billion in 2018, below 3 percent of the total economy – the level most economists consider sustainable. House Speaker John Boehner called the budget a “collection of rehashes, gimmicks, and tax increases that will make our economy worse.” Republicans challenged the underlying math, saying the budget double-counted deficit reductions already approved in an August budget deal and also claimed $848 billion in savings from ending the wars in Iraq and Afghanistan even though this money would not have been spent. (Sources: Associated Press, 2/13/12; American Hospital Association website, accessed 2/15/12) REGULATORY NEWS Haemonetics Corporation recently sent a letter to customers notifying them that the Food and Drug Administration has denied a biological license application (BLA) submission to produce/rescue sin-gle-units on Haemonetics LN832-00 kits (non-filtered double RBCs) used with MCS+8150. According to the Haemonetics letter, FDA stated in its denial letter to Haemonetics “that data submitted for single-unit recovery in the 510(k) application did not support single-unit recovery on LN832-00 dis-posable kits.” FDA also stated that the units could not be transfused, either as licensed or unlicensed products and that such recovered units needed to be destroyed. Haemonetics emphasized that this issue only applies to single (recovered) units collected on the non-filtered LN832-00 collection kit. The 832F-00, 822-2P and 822-00 are not affected by this issue. Only blood centers using the 832-00 kit are being notified with communications beginning this week. Haemonetics representatives are attempting to reach out to explain the issue verbally first and to answer any questions. That communication is being followed with a customer notification. Haemonetics believes this to be a unique situation as other blood establish-ments have applied for licensure of such single units and the FDA has granted licensure since the late 1990s. Haemonetics has not received any communication from FDA of plans to revoke licensure for this product. Haemonetics is in the process of working with FDA to provide the necessary data so the FDA will allow the use of this product for transfusion. America’s Blood Centers encourages any affected members to assess the situation in their centers and contact Haemonetics if they have any questions or concerns. Members can access more information in MCN 12-038 at: http://members.americasblood.org/go.cfm?do=FileCenter.List&category=MCNs. (Source: ABC MCN 12-038). GLOBAL NEWS The Danish National Board of Health recently changed its regulations regarding the screening of blood donors for HTLV and hepatitis B, the Funen Transfusion Service and South Danish Tissue



GLOBAL NEWS (continued from page 14) Center of Odense University Hospital in Denmark announced in a notice. Danish blood services be-gan testing for antibodies to HTLV-I/II in 1994, but in 1997 the regulation was changed, requiring that only first time donors and repeat donors who had traveled to endemic areas be screened. Testing for HTLV I/II was recently abandoned following advice from the Board of Transfusion Medicine, said the notice from Odense University Hospital. In 1983, testing for syphilis in Danish blood donors was discon-tinued after an investigation into cost-effectiveness. The Danish blood centers have now agreed to test first time donors for core antibodies to hepatitis B virus. The Danish National Board of Health expects that this test will be more valuable than anti-HTLV-I/II. The screening requirements for repeat donors are now: anti-HIV-1/2, HBsAg, antibodies against hepatitis C virus, and single donation NAT for hepatitis B virus, hepatitis C virus, and HIV-1. The recently changed Danish regulations now allows for a whole blood collection from first time donors, whereas previously, blood donors were interviewed and tested at their first blood center visit but could only give a blood donation two months later. This rule was intended to avoid donations from test seeking donors who may be at higher risk of infection by diseases transmiss-ible by transfusion. Although first time donors now can donate blood, there is still a requirement for a two month interval between the medical history interview and the first donation. (Source: Odense University Hospital submission, 2/16/12)

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

Total ABC Red Cell Inventory

Percent of Regional Inventory at

2 Days Supply or Less, Feb. 15, 2012

Daily Updates are available at: www.AmericasBlood.org

6% 8% 6% 9% 12% 7%

61% 55%50%

63% 58% 66%

31%32%

37%

23% 25% 22%

2% 5% 7% 5% 5% 5%

11-Jan 18-Jan 25-Jan 1-Feb 8-Feb 15-Feb

No Report Green (3 days or more)

Yellow (2 days) Red (1 day or less)

39%

10%

28%17%

3%

15%

0%

2%

E ast M idw est S outh W est

Percent of ABC Blood Supply Contributed by Each Region

East: 20%; Midwest: 25%; South: 24%; West: 31%


MEMBER NEWS Northern California Community Blood Bank (NCCBB) was recognized at the Arcata Chamber of Commerce’s Annual Membership Dinner and Awards Ceremony on Feb. 10, reported California newspaper the Arcata Eye. America’s Blood Cen-ters’ Immediate Past President Tom Schallert accepted the Non-profit Business of the Year Award on behalf of NCCBB. Mr. Schallert noted at the dinner that at least one Chamber member in attendance, Gene Joyce, had just come to the event after donating blood. The dinner took place at the Baywood Golf and Country Club in Arcata, Calif., and started with a meet-and-greet and a silent auction with items donated by Chamber members and supporters. Mr. Schallert noted in an e-mail to the ABC Newsletter that the award recog-nizes the hard work being done by staff and volunteers to serve hospitals, donors, and patients. (Source: Arcata Eye, 2/15/12) PEOPLE Toby Simon, MD, an America’s Blood Centers past president, has recently been promoted into a newly created position, senior medical director of Plasma and Plasma Safety at CSL Behring in King of Prussia, Pa., the company an-nounced in a recent press release. In this role, Dr. Simon will be responsible for the medical oversight and clinical safety associated with the CSL Plasma busi-ness. Dr. Simon will set policy and direction for the continued assurance that CSL Behring products are free from pathogens, working closely with the virolo-gy safety groups around the world. He will also assure that the health of plasma donors is appropriately managed and will be involved in additional activities in Research and Development. Dr. Simon joined CSL as corporate medical director of CSL Plasma in 2006 and later moved into Clinical Research and Develop-ment. While working for Blood Systems, Inc., Dr. Simon served as ABC president from 1995 to 1997. He is also a past-president of AABB. Dr. Simon has also served as chief medical officer with TriCore Refer-ence Laboratories in Albuquerque and vice president of Medical and Scientific Affairs at Serologicals Corporation. He began his career as a medical director of United Blood Services and a professor at the University of New Mexico School of Medicine, where he still holds a clinical appointment. (Source: CSL Behring press release, 2/15/12) Janet Busse, BS, MT(ASCP)SBB, MSQA, was recently appointed director of Quality Assurance for

Miller-Keystone Blood Center, headquartered in Bethlehem, Pa., the center an-nounced in a press release on Tuesday. Ms. Busse earned her bachelor’s degree in Medical Technology from Georgia Southern University, and her master’s degree in Quality Assurance from Southern Polytechnic State University. She is also an AABB Specialist in Blood Banking. She was most recently employed with the American Red Cross. In her new position, Ms. Busse is responsible for all quality assurance operations at Miller-Keystone Blood Center, including Food and Drug Administration, AABB, and compliance. (Source: Miller-Keystone Blood Center press release, 2/14/12)

PEOPLE (continued on page 17)


PEOPLE (continued from page 16) Larry Frederick, blood donation advocate and namesake of America’s Blood Centers Larry Frederick Award, has recently joined Blood Centers of the Pacific’s (BCP) Community Leadership Council, BCP announced in a press release on Tuesday. In his new role, he will help the blood center reach out to the communities of Sonoma County, including the city of Santa Rosa, his hometown. Years ago, Mr. Frede-rick used a tremendous amount of blood when he was injured while on duty as a police officer in Oakland, Calif. His tremendous gratitude for blood donors in-spired him to become an ardent blood donation awareness advocate. Mr. Frederick combined his love of cycling with his new passion for blood donation and over the next several years, he organized several bike rides throughout Cali-fornia – and across the US – to raise awareness for blood donation. In 1997, ABC created the first Larry Frederick Award, recognizing an individual for his or her contribution to the independent volunteer blood donation community. Larry served on the board of his then-local blood center, Blood Bank of the Redwoods, before it merged with neighboring Blood Cen-ters of the Pacific in July of 2011. “The only reason I’m alive today is because 110 donors I didn’t know, gave blood to save my life,” Mr. Frederick said in the release. “It is for this reason that I’m grateful to help the Blood Centers of the Pacific in continuing to serve our local community in Sonoma County, where I have lived and raised my family,” he added. “We’re thrilled that Larry is continuing his com-mitment to blood donation by helping us reach out to the communities of the North Bay, said BCP President Nora Hirschler, MD. “Having Larry’s firsthand experience with the power of blood donation, plus his unwavering enthusiasm for the cause will enable us to build an even stronger relationship with the local community.” (Source: Blood Centers of the Pacific press release, 2/14/11) MEETINGS March 7 FDA Workshop: “Design and Methodology for Postmarket Surveillance Studies

under Section 522 of the Federal Food, Drug, and Cosmetic Act,” Silver Spring, Md. The Food and Drug Administration will be hosting a workshop on March 7 at its White

Oak Campus in Silver Spring, Md., announced the Federal Register on Feb. 16. This workshop will provide a forum for discussion among FDA, industry, governmental agen-cies, academia, clinicians, and various stakeholders with experience in epidemiology, statistics, and biomedical research to advance the design and methodologies for medical device surveillance studies in the “post-market” setting, i.e., after FDA premarket ap-proval or clearance of the device and marketing of the device has begun. The meeting is set to take place from 8 a.m. to 5:30 p.m. EST. The workshop will also be available on a public workshop at: http://1.usa.gov/yYUcWI. More information on the workshop and registration is available at: http://1.usa.gov/wqe1mR.

Contact: Samantha Jacobs, [email protected] or Mary Beth Ritchey, [email protected].


CLASSIFIED ADVERTISING

Classified advertisements, including notices of positions available and wanted, are published free of charge for a maximum of three weeks per position per calendar year for ABC institutional members. There are charges for non-members: $139 per placement for ABC Newsletter subscribers and $390 for non-subscribers. Notices ordinarily are limited to 150 words. To place an ad, contact Leslie Norwood at the ABC office. Phone: (202) 654-2917; fax: (202) 393-5527; e-mail: [email protected].

POSITIONS AVAILABLE:

Chief Executive Officer. Central Jersey Blood Center in Shrewsbury, NJ is now accepting resumes for the position of CEO. Reporting to the Board of Trustees, the position serves as the ultimate authority in matters of operation, is responsible for fiscal and legal matters of corporation and for assuring that activities of manage-ment comply with the mission, quality manual and all regulatory requirements. You will be responsible for the recruitment efforts, blood collection, blood products and services, and the distribution of those products. Essential to the role is also the development of community and corporate relationships. Preparing annual budgets to support the attainment of the strategic plans. Must be able to be a team leader and relate to all levels within the organization. The CEO will exhibit a strong work ethic and a passion for inspiring others. Additional responsibilities include, but are not limited to: Develop-ing short and long term plans that address competition, customer service and human resources. Ideal candidates must have BS/BA degree and MBA preferable, strong preference given to individuals with extensive opera-tional/financial experience in blood centers. Fax resume to attention of: Donna Glassen, HR Director, (732) 933-7624 or email: [email protected].

Vice President, Technical Services. The Blood Bank of Delmarva is looking for a Vice President, Technical Services. Reporting to the President and CEO and serv-ing as an integral member of the Executive Management Team, the Vice President of Technical Services (VP) provides leadership to and directs, administers, and coordinates the Donor Services, Laboratory, and Inno-vation operational realms. Responsibilities: Provides leading edge thinking concerning the industry and best practices to the President/CEO and other key members of senior management; maintains current FDA, AABB and other regulatory agencies’ policy matters; and leads the development of overall management of the technical services strategy and aligns these in support of BBD

strategic goals and objectives. Qualifications: Technical Degree mandatory, a Master’s in business administra-tion or other related field and SBB certification is preferred; minimum 10 years experience in a manage-ment role ideally with a blood bank or health care organization; experience either as an employee or board member of a nonprofit organization preferred; superior management skills; and ability to influence and engage direct and indirect reports and peers. Interested candi-dates may apply by submitting cover letter, resume and salary requirements through www.Careerbuilder.com. Blood Bank of Delmarva is an Equal Opportunity and Affirmative Action Employer.

Manager Information Services/Quality Assurance. Carter BloodCare, the largest independent, community-based blood program in Texas, is seeking an expe-rienced QA professional. This position provides leadership in the establishment and maintenance of the Quality Program and the integration of quality manage-ment processes into all aspects of the IS department. The selected candidate will assist in managing company-wide controlled documents using the document man-agement system and will be responsible for compliance and regulations throughout the department including validation of all blood banking applications. Medical Technologist or bachelor’s degree in Quality Programs required; SBB certification and ISO 9000 Quality Sys-tem or AABB Quality Program implementation and maintenance a plus. Five to six years of quality program management and/or quality auditing or similar expe-rience in the blood banking industry and two to three years supervisory experience required. Apply on line at www.carterbloodcare.org.

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