INSIDE: AHA Report Urges Appropriate Use of Blood Products

2013 #41 November 15, 2013 AHA Report Urges Appropriate Use of Blood Products

The American Hospital Association (AHA) recently joined the growing number of organizations that have published recommendations for reducing the overuse of certain medical procedures. AHA’s recently published white paper, “Appropriate Use of Medical Resources,” has targeted blood management as one of the top medical interventions that should be included in the quest to reduce overuse. It has become clear that “over-diagnosis, overuse of treatments, and a ‘try every-thing’ approach to medical care have increased healthcare costs with little discernible improvement in health,” said AHA in the report. The white paper ex-amines the drivers in healthcare costs, enumerates contributing factors, and suggests ways that hospitals and AHA can play a role in addressing the appropri-ate use of medical resources. This paper builds on AHA’s “Ensuring a Healthier Tomorrow” report, published earlier this year, which identified two strategies to improve care, while achieving a sustainable level of healthcare spending: promote and reward accountability, and use limited healthcare dollars wisely. As an outgrowth of the latter, AHA com-piled this report with help from its Committee on Clinical Leadership, Physicians Leadership Forum, regional policy boards, and governing councils and commit-tees. Drivers of Overuse and Evidence for Change. “Years of fee-for-service finan-cial incentives, increased information availability, malpractice concerns, and societal desire to ‘try everything’ have helped drive the levels of procedure-based intervention and treatment that we see today,” said AHA. Despite these driving factors, there are many emerging healthcare reform efforts shining a light on the appropriate use of medical resources, with federal and state regulators, as well as private payers, watching closely to curb the rising costs of the Medicare and Med-icaid programs, explains AHA. From legislators taking action to curb excessive use of imaging, to regulatory agencies making inquiries regarding the “medical necessity” of certain procedures, the overuse of medical interventions has gained a fair deal of scrutiny in recent history. Emerging clinical evidence has also shown “an increase in diagnosis of disease due to more sensitive diagnostics, as well as the potential for increased harm through unneeded treatment.”

(continued on page 3)

INSIDE:

Our Space: Making Policy can be Like Making Sausage ....................... 2

ABC Offices Now Under Construction ................. 4

The FABC Welcomes Stephen Eason and Pascal George to its Board ............................ 5

ABC Quality Education Webinar to Tackle CLIA Hot Topics .................... 6

ABC and Migrant Students Foundation to Launch 6th Annual Cesar E. Chavez Blood Drive Challenge .. 6

BRIEFLY NOTED ............ 8

REGULATORY NEWS .... 9

GLOBAL NEWS ............ 11

STOPLIGHT®: Status of America’s Blood Centers’ Blood Supply 11

MEMBER NEWS ........... 12

PEOPLE ........................ 13

COMPANY NEWS ........ 14

MEETINGS ................... 15

POSITIONS AVAILABLE ................................... 15

ABC Newsletter -2- November 15, 2013

OUR SPACE

ABC Executive Vice President Louis Katz, MD

Making Policy can be Like Making Sausage

… You may love sausage but most of us don’t want to see it being made. At a meeting of the Food and Drug Administration’s Blood Product’s Advisory Committee (BPAC) this month, FDA presented what looks like an approvable confirmatory immunoblot for our human T-lymphotropic virus (HTLV) screening assays.

Having tested for HTLVs for 25 years without a licensed confirmatory test for donors with reactive screening, there are more than 200,000 donors with false positive results in limbo. The agency asked BPAC to consider calling “negative” a subset of common patterns on the blot historically called “indeterminate” (as has been done for decades throughout the “rest-of-world” with the test). FDA’s background documents and data pre-sented the confirmatory assay results of about 2,500 individuals. These results included no example of anyone with the relevant patterns demonstrating evidence of infection on follow-up including direct viral detection (using polymerase chain reaction testing and/or virus culture).

An approval that allows these negative interpretations could accomplish several things. It would allow straightforward, declarative counseling of donors with negative confirmatory tests, including those with these common, clinically irrelevant, historically indeterminate, tests – “you are negative.” We eliminate a mixed message we give donors with embarrassing frequency – “you have nothing of medical importance based on our test results, but sorry, you still cannot donate blood.” Second, a licensed confirmatory test would permit the development of reentry algorithms for screening false positive donors that provide the ultimate “unmixed” message, that their screening results have no medical significance – “you may come back and be a donor.” Lastly, it might set an example applicable to whatever indeterminate assays plague us going forward. ABC, AABB, and the American Red Cross, in a joint statement to BPAC, were complimentary of FDA for consider-ing the precedent of calling indeterminate patterns on an immunoblot negative for the purposes of donor counseling and reentry.

The proposed negative interpretations would have no impact on blood safety, since no donation with positive screening can be distributed, and no donor with persistent screening reactivity can be reentered into the donor pool. The committee, with the abundance of precaution for which it is recognized, could not endorse the pro-posed negative interpretations, although there is no evidence that they reflect an infectious or any other pathologic process. As a result of the discussion, an agreement was reached for further research to include follow-up of US donors having the patterns in question with complete serologic testing and appropriate fol-low-up, including direct detection methods (i.e., PCR). When the existing data are confirmed, maybe the sausage will be ready to eat.

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AHA Report (continued from page 1) For example, the overdiagnosis of cancers destined to be clinically unimportant has garnered much atten-tion due in large part to the invasive and debilitating effects of unneeded treatment. Another recently targeted medical intervention is the use of blood and blood products, with blood management programs on the rise in the last couple of years. AHA points to AABB’s guidelines for red blood cell transfusions (http://annals.org/article.aspx?articleid=1206681) as further evidence of efforts to encourage appropriate blood use. Just last year, The Joint Commission (TJC) and the Physician Consortium for Performance Improvement, convened by the American Medical Association (AMA), held a National Summit on Overuse to discuss the quality and patient concerns related to overuse of certain procedures (see ABC Newsletter, 9/28/12). Five advisory panels were formed, each focusing on a different medical intervention – one of which was appropriate blood management. The Value of Patient and Provider Education. “There is growing evidence that patient involvement and engagement in their healthcare results in a better patient experience, lower costs, and improved out-comes,” said the AHA report. Further, efforts to educate clinicians regarding appropriate use of medical resources are becoming more prevalent and showing positive results. As such, much of AHA’s recom-mendations involve increased patient engagement and provider education. One study showed that “patients who received enhanced support (through contact with health coaches) had 5.3 percent lower overall medical costs ... 12.5 percent fewer hospital admissions ... and 9.9 percent fewer preference-sensitive surgeries, including 20.9 percent fewer preference-sensitive heart surgeries.” AHA highlights several medical associations that have held forums and published recommendations for appropriate use of medical resources, such as the American College of Physicians, which recently shared recommendations for the use of evidence-based performance measures to assess the costs, benefits, and potential harms of diagnostic and therapeutic treatments. Similarly, in April 2012, the American Board of International Medicine Foundation launched the “Choos-ing Wisely” campaign, which encouraged US medical specialty societies to create lists of five common procedures or tests whose necessity should be discussed by patients and their physicians. Many of these lists include transfusion of blood products and blood management. AHA also emphasizes the importance of using measures to track overuse of medical procedures, and clinical guidelines to direct appropriate use of medical procedures and tests. Methods to Curb Overuse for Hospitals. “Since healthcare delivery occurs in the context of a larger system, it is imperative that all parts of that system commit to adherence to appropriate guidelines and that analysis of practice patterns should be as essential to the efficient operation of a hospital as quality measures and patient data.” As such, AHA recommends that hospitals and hospital systems:

Employ quality measures for overuse of lower value services as part of their overall quality ef-forts and report findings to their board, medical staff, and the field;

Ensure that clinicians are aware of the specialty society clinical practice guidelines and employ them in their clinical decision-making;

Encourage the use and adoption of clinical decision aids and other resources to help physicians better communicate with patients about the most appropriate care pathways;



AHA Report (continued from page 3)

Provide a structure for patients and their providers to have meaningful conversations about ap-propriate use of resources; and

Employee educational opportunities to communicate the implications of shared decision-making and the importance of reducing non-beneficial care.

As a starting point, AHA’s Committee on Clinical Leadership, created a top-five list of hospital-based procedures or interventions that should be reviewed and discussed by a patient and physician prior to proceeding:

Appropriate blood management in inpatient services; Appropriate antimicrobial stewardship; Reducing inpatient admissions for ambulatory-sensitive conditions; Appropriate use of elective percutaneous coronary intervention; and Appropriate use of the intensive care unit (ICU) for imminently terminal illness.

To help hospitals and healthcare systems implement its top-five list, the AHA is partnering with medical specialty societies engaged in the “Choosing Wisely” project to more broadly distribute tools and re-sources; collecting and disseminating relevant best practices; collecting and disseminating sample hospital policies concerning adherence to clinical practice guidelines; and encouraging the medical education community to consider whether additional training on non-beneficial care might be warranted. AHA created an accompanying discussion guide along with the white paper, and recommends that hospi-tal management share this document with hospital boards, medical staff, and community leaders to begin exploring this issue together. “I applaud AHA for coming on board in this arena,” said Louis Katz, MD, America’s Blood Centers’ executive vice president of SMT. “Integration of clinical trial and epidemiological data clearly demon-strating the overuse of transfusion in the US has been slow and is incomplete, but with the support of organizations like AHA, AMA, and TJC it should be possible to move quite speedily to more appropriate use of our resources.” Both documents can be accessed at http://bit.ly/17anKTz. (Sources: AHA’s “Appropriate Use of Medical Resources” white paper, 10/31/13; AHA “Appropriate Use of Medical Resources” discussion guide, 10/31/13)

ABC Offices Now Under Construction Construction has begun! The America’s Blood Centers offices in downtown Washington, D.C. are un-dergoing renovations to consolidate the staff from two floors to one in the historic Folger Building. We are tearing down walls to open up our space on the seventh floor, adding more workstations, downsizing furniture, and digitalizing files to reduce clutter. The renovation and consolidation onto one floor will save ABC more than $250,000 over the next four years. We expect to complete the work by the begin-ning of 2014. In the meantime, there may be times of server or e-mail disruption. We are working to minimize disruptions in the workflow and will continue to provide all the services that members expect from ABC. We appreciate your patience during this renovation process.


The FABC Welcomes Stephen Eason and Pascal George to its Board The Foundation for America’s Blood Centers announced this week that Stephen Eason, MBA, and Pascal George, MBA, have been elected to serve on the FABC board. Mr. Eason currently serves as the Founda-tion director for Carter BloodCare, Bedford, Texas, and Mr. Pascal is the CEO of Central Jersey Blood Center. Mr. Eason has been with Carter BloodCare for 13 years, originally hired to start a fundraising/development department. His position has expanded and now includes oversight of the Carter BloodCare Foundations’ Population Health Initiatives pro-gram, which targets cardiovascular disease and diabetes risk in adolescent blood donors. Mr. Eason has served on the FABC’s Grant Review Committee, as well as AABB committees, including the Annual Meeting, Membership, and Peripheral Blood Stem Cell Steering Committees. Locally, Mr. Eason is a board member and past chair of the Center for Community Health Advisory Board, which is part of the University of North Texas Health and Science Center. He holds a Bachelor of Sci-ence degree, as well as a Master of Business Administration. “The FABC is uniquely positioned to positively influence the availability, quality, and safety of blood transfusion through direct and indirect support of member blood centers and affinity groups,” said Mr. Eason.

Born in France, Mr. George completed graduate studies in business administra-tion and a few years as a human resources manager before moving to the US. He earned a Master of Business Administration from the University of Penn-sylvania’s Wharton School of Business, and quickly reached an executive position with the SUNY Health Science Center in Brooklyn, N.Y. He went on to lead the financial turnaround of a distressed inner-city hospital as its vice president of operations. Switching industries, Mr. George began to lead the emerging services division

for New York Blood Center, later moving into corporate administration to im-plement a decentralization plan. He then took on chief operating officer responsibilities, reorganizing operations of the progenitor cell therapy sector of the blood center. He later took on full operational re-sponsibility of this $300 million-business. He has shared his 25 years of executive and operational leadership experience as a consultant for CEOs of small to medium organizations facing difficult chal-lenges.


INSIDE ABC

The programs and services described in the Inside ABC section are available to ABC member blood centers and their staff only, unless otherwise specified.

Steve Eason, MBA

Pascal George, MBA


INSIDE ABC (continued from page 5) “I am delighted and humbled to join an organization which funds and fosters innovation and collaboration at a time when financial stress and competitive pressure may well hinder progress essential to our indus-try’s continued mission of saving lives,” said Mr. George in regard to joining the FABC board. “I would like to welcome both Steve and George to the FABC board. The Foundation will undoubtedly benefit from their leadership and blood center expertise,” said FABC Board Chair Francine Décary, MD, PhD.

ABC Quality Education Webinar to Tackle CLIA Hot Topics America’s Blood Centers’ Quality Education Committee will hold a webinar titled “CLIA Hot Topics-Challenges in Determining Employee Qualifications and Assessing Personal Competency” on Dec. 12 at 3 p.m. EST. During the webinar, Penny Meyers, of the Centers for Medicare & Medicaid Services’ Division of Labor-atory Services, will present an overview of CLIA competency regulations with special emphasis on the six elements of competency assessment, competency assessment for supervisors, and required documenta-tion for verifying employee qualifications. Jill Drummond, of Blood Systems, and Kathy Paulick, of Community Blood Center-Dayton, will focus on their center’s processes and strategies to meet CLIA employee qualifications documentation and competency assessment regulations. ABC recommends that webinar attendees review the following materials prior to the webinar: http://go.cms.gov/1buFLk4 and http://go.cms.gov/1aEDKx4. ABC members can find webinar login de-tails in MCN 13-148 at http://members.americasblood.org/go.cfm?do=FileCenter.View&fid=4612.

ABC and Migrant Students Foundation to Launch 6th Annual Cesar E. Chavez Blood Drive Challenge

America’s Blood Centers announced last week that it will partner once again with the Migrant Student Foundation in 2014 for the 6th annual National Cesar E. Chavez Blood Drive Challenge. This event, founded in 2009, seeks to celebrate Cesar E. Chavez’s legacy by engaging college students to promote health education, health science careers, civic engagement, and saving lives. Over the past five years, the program has collected more than 60,000 units of blood from blood drives across the country, while also educating students about the increased need for blood donors, especially within the minority population. Through this national service learning initiative, US Latino/Hispanic college students are encouraged to organize a blood drive campaign on their campus, competing with other blood drives across the country to win the coveted title of “Most Successful Blood Drive.” Each campus campaign is led by a selected student organizer who is responsible for designing a donor recruitment campaign in collaboration with their local blood center. This year, the Migrant Student Foundation has launched a new website (www.chavezchallenge.org) dedi-cated to this ever-growing program, providing up-to-date information on the program, resources, and information for 2014. The Migrant Student Foundation also announced the Chavez Challenge Partner Program this year, as the foundation is seeking to partner with blood centers that are looking to take their campus programs to the next level. These dedicated partnerships will allow the organization to be more



INSIDE ABC (continued from page 6) strategic and efficient in their efforts. More information about this program can be found at www.chavezchallenge.org/community/blood-centers. Growing upon the success of last year’s campaign, the foundation will now offer 10 scholarships to fur-ther reward participating college students. Scholarship winners, selected from the top 50 “Most Successful Blood Drives,” will receive a $1,000 stipend to be used towards education expenses or to be donated back to their participating student organization. Scholarship application can be found at www.chavezchallenge.org/students/scholarships. As of Nov. 1, 176 student organizations from last year’s 251 participating campuses had confirmed par-ticipation for 2014. The foundation will prioritize its recruitment efforts to reach the 2014 goal of 300 schools in the service territories of partner blood centers. However, blood centers are highly encouraged to recruit students themselves, further securing campaign activity for their blood center within the college campuses within their service area. Those wishing to participate in the blood drive challenge or who have additional questions may contact Glen Galindo at [email protected].

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BRIEFLY NOTED The journal Science recently featured a letter from the World Health Organization (WHO) defend-ing its voluntary non-remunerated blood donation (VNRBD) policy, in response to an article published in May suggesting benefits from providing economic rewards to blood donors. “WHO has long recommended VNRBD as the foundation for safe, reliable, and adequate blood supplies,” writes Neelam Dhingra, MD, of WHO’s Health Systems and Innovation Cluster, in the letter published Nov. 8. In their Policy Forum “Economic Rewards to Motivate Blood Donations,” Nicola Lacetera and colleagues argue that “the most relevant empirical evidence shows positive effects of offering economic rewards on donations” and suggest that WHO consider changing its policy (see ABC Newsletter, 5/31/13). Dr. Dhingra writes that WHO disagrees with Lacetera and colleagues’ conclusion. She explains that they did not distinguish between unacceptable economic rewards for blood donation like supermarket vouchers, and acceptable small tokens like a free cholesterol test or T-shirt. While Lacetera, et al. contend that the WHO position is based on uncontrolled and non-random studies, Dhingra argues that use of evidence in public health decision-making is more complex than in clinical practice. Such decision-making often draws on sources beyond the traditional hierarchy of study designs, while addressing equity, transferabil-ity, acceptability, patient preference, and social values. She adds that “a change in VNRBD policy would require evidence across a range of different settings that addressed safety, donor recruitment, impact on social cohesion and solidarity, effect on concomitant VNRBD programs, and avoidance of the exploita-tion of the poor and vulnerable, as well as the assessment of potential negative health and social side effects on a large scale.” She also points to evidence that VNRBD provides the safest blood supply and improves the availability of blood. Changing the VNRBD policy may also lead to exploitation of the un-derprivileged population in need of money by providing them with financial incentives to donate blood, which opposes the directives of the United Nation’s Universal Declaration on Bioethics and Human Rights, said Dr. Dhingra. Gilles Folléa, MD, submitted a comment on behalf of the European Blood Alli-ance, published online, also supporting the WHO VNRBD policy. Lacetera and colleagues responded to the letter, maintaining their conclusion that economic incentives may benefit voluntary blood donation. They add that their study did not include cash incentives, and that they agree that ethical principles should also guide discussion about blood donations. The letter is available to Science subscribers or for purchase at www.sciencemag.org/content/342/6159/691.full. Citations: Lacetera N, et al. Public health: Economic rewards to motivate blood donations. Science. 2013 May 24:340(6135):927-8. Dhingra N, et al. In defense of WHO’s blood donation policy. Science. 2013 Nov. 8;342(6159):691-2. NIH Director Francis Collins, MD, hosted a town hall meeting on Oct. 23, during which he con-demned the effects of an “unnecessary and ultimately pointless shutdown” that closed the government Oct. 1 to 16 and idled 75 percent of the NIH workforce, reported the NIH Record. For the first half of the session, Dr. Collins outlined a steadily deteriorating political landscape that has in-cluded first multiple threats of shutdown, then the reality of budget sequestration, culminating in a 16-day shutdown coinciding with the start of federal fiscal year 2014. Federal regulations barred any but “ex-cepted” employees – those with responsibility for preservation of life (human and animal) and property – from coming to work. During the second part of the meeting, Dr. Collins answered questions from both the audience and via e-mail. He noted that five of six Nobel Prize laureates who were named as the shut-down began were furloughed. Dr. Collins lambasted the damage imposed by sequestration, which has denied NIH $1.55 billion in funding in fiscal year 2013 and resulted in an inability to award some 640 research project grants that were deemed worthy of NIH support. An estimated 750 patients were not seen at the Clinical Center, due to sequestration, he reported. Dr. Collins added that unless sequestration



BRIEFLY NOTED (continued from page 8) is undone, it will result in $18.8 billion in losses to NIH over the next decade. Even for those permitted to work during the shutdown, “the rules we had to live under during the shutdown were rigid and onerous,” said Dr. Collins, who noted that 17 years have passed since the last government-wide shutdown. “We found ourselves having to adhere to various rules which were actually quite offensive, and we had no ability to freelance.” He predicted a slew of inquiries from the General Accounting Office, the inspector general, and various congressional committees during which NIH “will have to defend how we interpret-ed our activities during the government shutdown.” He called the effect of the shutdown on NIH Clinical Center patients “most gripping” to the public. In a normal week, some 200 new patients are admitted, 15 percent of whom are children. Under shutdown rules, only patients in life-threatening straits could be admitted. He concluded by commending the NIH staff for their ability to rebound quickly following the shutdown. “I am humbled and thankful to be associated with all of you ... your professionalism is a de-light to behold,” he said. More information about the town hall meeting can be found at http://1.usa.gov/1hSyltV. (Source: NIH Record, 11/8/13) REGULATORY NEWS On Oct. 11, the Food and Drug Administration approved CareFusion’s amended label regarding the dry-time for ChloraPrep skin disinfectant, a change about which CareFusion has now issued a customer letter. The ABC Newsletter informed readers of this approval on Oct. 25, noting that we would publish an update once the customer letter reflecting the approved label change became available. The customer letter can be accessed at http://bit.ly/HRESHs. On Dec. 20, 2012, America’s Blood Centers became aware that FDA issued a labeling change for specific classes of skin antiseptic products widely used by ABC members, including ChloraPrep, which would alter the drying time from 30 seconds to three minutes due to episodes of patient burns in surgical applications in the presence of an ignition source (e.g., electrocautery) (see ABC Newsletter, 1/11/13). ABC, AABB, and the American Red Cross together advocated within FDA and the company to remedy this issue, explaining that this new dry-time requirement should not apply to the blood center setting, as there are no ignition sources at the phleboto-my site, and the change would significantly impact operations. The new dry-time labeling will reflect a 30-second dry-time on dry sites (e.g., abdomen, arm) and a one-minute dry-time on wet sites (e.g., groin), according to the letter. (Source: CareFusion customer letter, 11/1/13) The Occupational Safety and Health Administration (OSHA) recently published a proposed rule that would likely affect reporting requirements for blood centers regarding workplace injuries and illness. The proposed rule, “Improve Tracking of Workplace Injuries and Illnesses,” would “amend the regulation on the annual OSHA injury and illness survey of 10 or more employers to add new electronic reporting requirements.” One of these changes will require establishments that are required to keep injury and illness records under OSHA’s regulations for recording and reporting occupational injuries and ill-nesses, and that had 250 or more employees in the previous year, to electronically submit information from these records to OSHA (or OSHA’s designee) on a quarterly basis. If adopted, this rule would also require establishments that are required to keep injury and illness records under OSHA’s regulations for recording and reporting occupational injuries and illnesses, had 20 or more employees in the previous year, and are in a certain designated industries, to electronically submit the information from the OSHA annual summary form to OSHA. This requirement will replace OSHA’s annual injury and illness survey, authorized by the current version of the regulation. Lastly, OSHA will require all employers who receive notification from OSHA to electronically submit specified information from their Part 1904 injury and illness records to OSHA. America’s Blood Centers is currently analyzing the proposed rule to determine



REGULATORY NEWS (continued from page 9) how this will affect blood centers. The proposed rule can be accessed at http://1.usa.gov/1bElR4c. (Source: Federal Register, 11/8/13) The Department of Health and Human Services (HHS) Secretary Kathleen Sebelius announced on Nov. 7 that $150 million in awards under the Affordable Care Act will be given to support 236 new health center sites across the US. These investments will help care for approximately 1.25 million pa-tients, according to an HHS press release. Community health centers play an especially important role in delivering healthcare services in communities with historically high uninsured rates. These centers are also on the front-line of helping uninsured residents enroll in new health insurance options available in the Health Insurance Marketplaces under the Affordable Care Act, through expanded access to Medicaid in many states, and new private health insurance options and tax credits. “We are committed to providing more people across the country with the quality patient-centered care they deserve,” said Secretary Sebelius. “Health centers are key partners in the improving access to quality, affordable health care services for those who need it most. With new, affordable health insurance options available under the Affordable Care Act, community health centers are also key partners in helping uninsured residents sign up for health coverage – many of whom have been locked out of the health insurance market for years.” As community-based and patient-directed organizations, health centers are well-positioned to be responsive to specific healthcare needs of their community, according to the press release. Through the Affordable Care Act’s commitment to expanding access to high quality healthcare for all Americans, these grants will support the establishment of new full-time service delivery sites. Health centers also link individuals to care through outreach and enrollment, assuring that individuals in their communities have the information and assistance they need to enroll in care through the Health Insurance Marketplace. More information is available in the press release at http://1.usa.gov/17OW0r9. (Source: HHS press release, 11/7/13)

mailto: [email protected]

mailto: [email protected]


GLOBAL NEWS China, the only country that still systematically takes organs from executed prisoners for use in transplant operations, plans to end the controversial practice by the middle of next year, reported Reuters on Nov. 2. By mid-2014, all hospitals licensed for organ transplants will be required to stop us-ing organs from executed prisoners and only use those voluntarily donated and allocated through a fledgling national system, Huang Jiefu, MD, a former Chinese deputy health minister who heads the or-gan transplant reform, told Reuters. The supply of human organs falls far short of demand in China, due in part to a traditional belief that bodies should be buried or cremated intact. An estimated 300,000 pa-tients are wait-listed every year for organ transplants, and only about one in 20 ultimately receives a transplant. The shortage has driven a trade in illegal organ trafficking, and in 2007, the government banned transplants from living donors, except spouses, blood relatives, and step- or adopted family mem-bers. Officials in Beijing said in August that the government would begin to phase out the practice of using executed prisoners’ organs this month. Dr. Huang explained that the practice of systematically tak-ing organs from prisoners does not align with universal ethical standards, and that the Chinese government has received much criticism for this practice. The courts, which oversee executions, have been told that they are no longer allowed to offer organs to hospitals. The Reuters article can be viewed at http://reut.rs/19lMr3i. (Source: Reuters, 11/2/13)

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

Total ABC Red Cell Inventory

Percent of Regional Inventory at

2 Days Supply or Less, November 14, 2013

Daily Updates are available at: www.AmericasBlood.org

4 3%

15 %1 1%

17 %

4 %

0%

0 %

0 %

E as t M id w es t Sou th W es t7%

14% 8% 8% 11% 7%

66%65%

59%69% 66% 72%

23% 17%27%

19% 21% 20%

4% 4% 6% 4% 2% 1%

9-Oct 16-Oct 23-Oct 30-Oct 6-Nov 13-Nov

No Report Green (3 days or more)

Yellow (2 days) Red (1 day or less) Percent of Total ABC Blood Supply Contributed by Each Region

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


MEMBER NEWS Community Blood Center, Appleton, Wis., held a grand opening and ribbon-cutting for its new Oshkosh Donor Center on Oct. 29. Blood donors, blood center staff, blood recipients, politicians and community leaders were present for the event. The ribbon-cutting ceremony included a personal “thank-you” from the mother of a boy who received a blood transfusion several years ago. The new donor center is 2,200 sq. ft., which is 50 percent bigger than the previ-ous Oshkosh location. It has more medical history rooms, additional donation beds, and an expanded cafe area. “More than 7,000 people in the Oshkosh area have given blood in the last 12 months,” said Andrea Michaud, vice president of Donor Relations and Opera-tions at Community Blood Center. “This new, larger donor center will help us serve an increasing number of blood donors in the Oshkosh area. We’re grateful for everyone who has donated blood in Oshkosh, and look forward to seeing them again in the future!” (Source: Community Blood Center press release, 11/6/13) Community Blood Center of the Carolinas (CBCC) recently became the third America’s Blood Centers member to implement Nouvation’s OTIS-Blood Bank 8, announced Nouvation in a Nov. 1 press release. OTIS-Blood Bank 8 is an occurrence tracking infor-mation system developed by Nouvation to facilitate process improvement and regulatory compliance. “Our hospital partners expect us to be vigilant in promoting blood product safety while ensuring an adequate supply for our local patients,” said Martin Grable, president and CEO of CBCC. “OTIS is a powerful tool for process improvement and for helping us to be efficient and compliant with regulatory requirements.” OTIS features a “plug-and-play” quality management system to help blood banks improve quality, boost efficiency, and facilitate compliance. Some features include a virtual scanner, ad hoc queries, alerts with Food and Drug Administration dead-lines, and data export capabilities. OTIS also includes a status code system and LED-like indicators to visually verify completion of each investigative step. “We started using OTIS in September and it has already contributed to the management and tracking of quality metrics,” said CBCC Quality Assurance Director Deanne M. Wells, MLT(ASCP), CQA(ASQ). “We have moved on from using a quality man-agement system that wasn’t designed for blood banks and have consolidated three databases into one through OTIS, making process improvement seamless, fast and evidence-based.” The Nouvation press release can be viewed at http://bit.ly/1breRG8. (Source: Nouvation press release, 11/1/13)

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.

Community Blood Center, Appleton, President and CEO Rick Hart cuts the ribbon at the grand opening of the new Oshkosh Donor Center surrounded by blood center staff and community supporters.


PEOPLE Al Whitney, 75, an avid blood donation advocate and frequent donor, has embarked on yet another jour-ney to donate platelets and encourage others to do the same at blood centers across the US. Mr. Whitney completed his nearly five-year mission to donate platelets in all 50 states as part of his “Platelets Across America” campaign, which he created to raise awareness of the need for blood and platelets (see ABC Newsletter, 8/17/12). And now, Mr. Whitney is keeping the promise he made in August 2012 upon completing his 50-state tour – to keep on visiting blood centers. He has just begun a 1,600-mile trip to visit blood centers across the northern, western, and southwest-ern US, where he will donate blood and visit the local community to encourage others to give blood. He began his trip at Memorial Blood Centers in St. Paul, Minn., where he donated a double unit of platelets. Mr. Whitney then depart-ed on Nov. 3 and hit the road for United Blood Services (UBS) in Billings, Mont., where he went out with two donor recruiters to help with blood drive signups and to educate young people at two high schools in the area. “We were quite fortunate to have the opportunity to visit with Al these past couple of days,” said Lesli Asay, the regional donor recruitment director at UBS, Billings. “We at UBS were so happy to be part of Al’s final journey last year, as we were states 49 (Montana) and 50 (Wyoming). In my opinion, any cen-ter that has an opportunity to work with Al, is a center moving toward success.” Following his UBS visit in Montana, Mr. Whitney headed to Inland Northwest Blood Center in Spokane, Wash. On Nov. 14, he flew out to the Reno, Nev. UBS location, and will return to Washington on Nov. 16. From there, Mr. Whitney is headed south to San Diego, Calif., where he will visit with San Diego Blood Bank. His other destinations include New Mexico, Arizona, Texas, and possibly Louisiana. When asked why he would embark on yet another blood donation journey, Mr. Whitney responded simply, “Because the need is still there, and we can encourage others to be blood donors.” Blood centers wishing to contact Mr. Whitney may reach him at [email protected]. David Perez, president and CEO of Terumo BCT, was awarded the 2013 Visionary Award by the Colo-rado BioScience Association (CBSA). Mr. Perez, a previous board member of the Foundation for America’s Blood Centers, was recognized on Nov. 7 at the CBSA’s 2013 Annual Awards Dinner. The event, held at the Denver Marriott City Center, is designed to showcase and honor individuals and companies who have made a signif-icant impact on Colorado’s bioscience industry, and included more than 200 industry leaders. The Visionary Award that Mr. Perez received is a special honor designated for CBSA’s 10th Anniversary Celebration. Selected as the sole recipient of this award from an elite group, Mr. Perez was recognized for his contributions to the industry as Terumo BCT’s president and as an active member in a number of organizations at the state and national level. He has a reputation as a dedicated lead-er and visionary for the industry, continually looking ahead to build the bioscience industry, said Terumo BCT in the release. Mr. Perez served on the CBSA board of directors from 2010 to 2013 and continues to remain involved with the association. “We are honored to present David Perez with the Visionary Award for his outstanding work in the bioscience community. He is a great champion for bioscience in Colora-do,” said April Giles, CBSA president and CEO. (Source: Terumo BCT press release, 11/8/13)


Al Whitney donating platelets at United Blood Services in Billings, Mont., last year, which marked the 49th

state in his “Platelets Across America” campaign.


PEOPLE (continued from page 13) Stella T. Chou, MD; William Janssen, MD; George J. Murphy, PhD; Robert B. Neuman, MD; and Sean Stowell, MD, PhD were recently awarded 2013 National Blood Foundation (NBF) Scientific Re-search Grants, announced NBF in a press release on Tuesday. Each individual is awarded up to $75,000 to pursue either a one- or two-year research project in transfusion medicine or cellular therapies. NBF is a non-profit organization that supports research and education that advances transfusion medicine and cel-lular therapies by funding scientific research that benefits patients and donors. “For almost 30 years, the NBF has awarded competitive science research grants to talented young investigators working to advance transfusion medicine and cellular therapies,” said James Zimring, MD, PhD, chair of the NBF’s Grants Review Committee. “By investing in these researchers, the NBF has played an important role in trans-forming the field, and ultimately improving the lives of patients and donors.” Since 1985, the NBF has dispersed more than $8 million in grants to approximately 200 early-career researchers through its Scien-tific Research Grants Program. Grant proposals are evaluated on the basis of their scientific merit and relevance to and impact on transfusion medicine or cellular therapies. These grants are made possible by contributions from NBF’s Council on Research and Development (CORD) members and NBF Partners Program members, along with gifts from individuals, institutions, and foundations. Dr. Chou, of Chil-dren’s Hospital of Philadelphia and the Perlman School of Medicine at the University of Pennsylvania, is conducting a grant project called “Red Blood Cell Generation from Human Induced Pluripotent Stem Cells: a New Tool for Transfusion Medicine.” Dr. Janssen, from National Jewish Health and the Universi-ty of Colorado, Denver, is working on research titled “Degradation of the Pulmonary Endothelial Glycocalyx in Transfusion-Related Acute Lung Injury.” Dr. Murphy, from Boston University Medical Center and the Center for Regenerative Medicine, is using the grant money to support his project, “Plu-ripotent Stem Cells in the Modeling of Blood Disease and the Development of Potentially Transfusable Human Red Blood Cells and Platelets.” Dr. Neuman is from Emory University School of Medicine and is a fellow of the Cardiovascular Disease Clinical Research Track. His grant will support the “Physiologic Effects of RBC Storage in Chronic Transfusion Recipients: Vasoreactivity, Exercise Capacity, and Oxy-gen Consumption” project. Dr. Stowell, of Emory University School of Medicine, is conducting a project called “Characterization of Immunity and Tolerance Following RBC Transfusion.” Complete descriptions of the grant recipients’ research can be found at http://bit.ly/S3m4IH. COMPANY NEWS Novartis announced in a statement on Monday that it has agreed to sell its blood transfusion diag-nostics unit to Spanish healthcare company Grifols for $1.68 billion. The transaction is expected to be completed in the first half of 2014, said the statement. “The sale of the Novartis blood transfusion diag-nostics unit enables us to focus more sharply on our strategic businesses, while providing Grifols with a platform for global expansion,” said Joseph Jimenez, CEO of Novartis. “I am especially pleased that the agreement with Grifols provides our associates with an opportunity to join a company that will focus on growing this business aggressively.” Novartis is conducting a strategic review to determine which market segments it wants to stay in, reported Bloomberg. The company has said it wants its businesses to be among the industry leaders or will otherwise consider divesting them, according to Bloomberg. Headquar-tered in Barcelona, Spain, Grifols is the world’s third largest producer of plasma-derived therapies, said Novartis. The Novartis press release can be viewed at http://bit.ly/1btgPaE.


MEETINGS Feb. 7, 2014 FDA Sickle Cell Disease Public Meeting on Patient-Focused Drug Development, Silver

Spring, Md. The Food and Drug Administration will hold a public meeting and an opportunity for

public comment on Patient-Focused Drug Development for sickle cell disease on Feb. 7 from 10 a.m. to 4 p.m. at FDA’s White Oak Campus in Silver Spring, Md. Patient-Focused Drug Development is part of FDA’s performance commitments in the fifth au-thorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients’ perspectives on the impact of sickle cell dis-ease on daily life and on available therapies for sickle cell disease. Registration to attend the meeting must be received by Jan. 27, 2014. Those interested may register at https://patientfocusedsicklecell.eventbright.com. More information is available in the Federal Register announcement http://1.usa.gov/1a9sahF.

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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 $279 for non-subscribers. Notices ordinarily are limited to 150 words. To place an ad, contact Leslie Norwood at the ABC office. Phone: (202) 654-2917; fax: (202) 393-5527; e-mail: [email protected].

POSITIONS AVAILABLE: IT Business Analyst/Project Coordinator. This Okla-homa City, OK position will be responsible for the execution, development, and delivery for assigned pro-ject engagements and provide the critical interactions between all business areas and IT. Other highlights of the position are to build project plans (tasks, timetables, milestones, dependencies, resources needed, etc.). Pro-vide project direction/planning, coordination, implementation, execution, scope control, quality and completion of specific projects. Create training materials and conduct training courses. Qualifications include a bachelor’s degree in Computer Science or Business emphasis or equivalent experience. Seven plus years of direct work experience in a business analysis and project coordination capacity. OBI provides a competitive sala-ry and benefits package including Health, Dental, Vision, Life, LTD, Flex Plan, PTO leave, Tuition Reim-bursement and 401k Plan. Please apply online at: http://obi.org/careers/. Applications/resumes will be accepted through 12/13/2013. Our facility is located at: 901 N. Lincoln Boulevard, OKC, OK 73104. EOE M/F/D/V Drug Free Work Environment Donor Services Director. The Blood Alliance (TBA), a progressive, growing company, is now looking for someone to be our Donor Services Director. This is a position that requires an assertive problem solver who loves a fast-paced environment, and who can motivate

people to do their best. Candidates must possess excep-tional interpersonal skills, be organized, energetic and have a record of exceeding regulatory and quality stand-ards, optimizing customer values, prioritizing patient and donor care and safety. Responsibilities include, but are not limited to, strategic direction of assigned de-partmental functions, goals, objectives, and process improvement initiatives; supervisory responsibility for multiple levels of management and staff; the develop-ment and effective administration of departmental operating and capital budgets. In addition the Director is responsible for day-to-day judgment, decisions, and actions to prioritize and ensure compliance with appli-cable standards, regulations, and TBA specifications. Bachelor’s degree in Business Administration, Medical Technology or Nursing in addition to seven to 10 years of related operations management experience, five of which in a senior leadership role is required. Excellent written and oral communication skills, focused on train-ing, presentations, customer maintenance, and group dynamics are required. Please visit our website www.igiveblood.com to apply today. Director of Quality Assurance. Central California Blood Center in Fresno, Calif. is recruiting for a Direc-tor of QA. Successful candidate will be medical



POSITIONS (continued from page 15) technologist, CLS preferred, with five years’ experience in blood banking and/or operations in regulated indus-try. Responsible for review of regulatory/guidance documents for application; hosts external audi-tors/inspectors as needed; performs internal audits; assists with management of licenses and certificates; reviews error reports and corrective actions. Fosters strong process control through appropriate SOP review and participation in validation activities as needed. Excellent working knowledge of industry regulatory and accreditation standards required; previous experience in auditing and/or technical writing preferred and excellent organizational/interpersonal communication skills. Minimum of five years of progressive leadership experi-ence in quality management field required. Minimum five years progressive experience in Quality Systems preferred. CCBC offers a competitive salary and benefit package for this position that is a vital member of our Senior Management Team. To apply please fax resume to (559) 224-1310, or post www.donateblood.org; or mail to Central California Blood Center, 4343 W. Hern-don Ave, Fresno, CA 93722. EOE

Documents

INSIDE: AHA Report Urges Appropriate Use of Blood Products