Transfusion of Patients Undergoing Percutaneous Coronary
Transcription
Transfusion of Patients Undergoing Percutaneous Coronary
2014 #8 INSIDE: Our Space: The Clock is Ticking .......................... 2 ABC Webinar to Share Results of its 2012 Employee Turnover Survey .......................... 4 RESEARCH IN BRIEF .... 4 BRIEFLY NOTED ............ 6 February 28, 2014 Transfusion of Patients Undergoing Percutaneous Coronary Intervention Associated with Higher Risk of Adverse Events Many studies have shown variation in the use of red blood cell (RBC) transfusion among patients with cardiac disease, and there are currently no evidence-based guidelines for transfusion in patients with coronary artery disease. A new large study of patients undergoing percutaneous coronary intervention (PCI) confirms the variation in transfusion practices and identified an association of transfusion with increased risk of in-hospital adverse cardiac events. REGULATORY NEWS .... 6 THE WORD IN WASHINGTON............. 8 GLOBAL NEWS .............. 9 INFECTIOUS DISEASE UPDATES .................. 10 STOPLIGHT®: Status of America’s Blood Centers’ Blood Supply.... ................................... 11 MEMBER NEWS ........... 11 PEOPLE ........................ 12 COMPANY NEWS ........ 13 MEETINGS ................... 13 POSITIONS AVAILABLE ................................... 14 CALENDAR ................... 16 Previous studies have associated transfusion in acute coronary syndromes with an increase in risk of myocardial infarction (heart attack) and death. However, little is known about transfusion practices and outcomes in patients undergoing PCI (angioplasty), which uses a catheter to open blocked coronary arteries. In the study published Feb. 26 in The Journal of the American Medical Association, Matthew W. Sherwood, MD, and colleagues of Duke Clinical Research Institute in Durham, N.C., report a retrospective cohort study examining transfusion practices in a large number of patients from around the US who underwent PCI. The researchers determined the current patterns of blood transfusion among these patients and the association with adverse cardiac outcomes across hospitals in the US by analyzing data on all patient visits that included PCI entered into the CathPCI Registry from July 2009 to March 2013. The CathPCI Registry is the largest ongoing national database of PCI in the US. The authors calculated transfusion rates in the overall population and by hospital, and measured the association of transfusion with myocardial infarction, stroke, and death after accounting for a patients propensity for transfusion. They included 2,258,711 patient visits at 1,431 hospitals in the analysis. There were 48,430 patient visits during which the patient received a post-PCI transfusion. The overall transfusion rate was 2.14 percent. There was considerable variation in transfusion practice among patients undergoing PCI and in transfusion thresholds among hospitals. When hospitals were grouped by low, medium, and high transfusion rates, transfusion was more frequent at all post-procedure hemoglobin values at high-transfusing hospitals compared with medium and low. High-transfusing hospitals had a transfusion hemoglobin threshold of 9 to 10 g/dL, whereas low-transfusing hospitals had a threshold between 8 and 9 g/dL. (continued on page 3) ABC Newsletter -2- February 28, 2014 OUR SPACE ABC CEO Christine S. Zambricki, DNAP, CRNA, FAAN The Clock is Ticking Whether talking about America’s Blood Centers or our member centers, there are two rudimentary contributors to the financial equation. Decreasing costs and increasing revenue are essential to the bottom line. Sometimes trimming costs can be a delicate proposition. The need to meet or exceed member needs now and in the future must be balanced with the handling of short-term priorities. Often alternative sources of revenue are difficult to find. I would like to share with you today some of ABC’s activities to reduce costs and increase revenue as we strive to assure financial accountability to our members. ABC’s board of directors, previous Interim CEO Bill Coenen, and the ABC senior leadership team made changes last year that continue today as examples of careful stewardship of member’s dues. Three staff positions were eliminated and a data analyst consultant was terminated, cutting costs by $260,000. We have reassigned roles and responsibilities, established teams, and through cross-training and staff development, ABC functions more efficiently and productively. We do not intend to replace these positions. ABC also consolidated its office space in Washington D.C. from two floors to one. As of Jan. 1, ABC moved all operations to the 7th floor, and rent-generating sub-tenants now occupy the 9th floor, paying approximately $70,000 per year. Renovations were made to the 7th floor in order to accommodate all ABC staff, and we are in the process of extending our lease agreement in order to depreciate the cost to our economic advantage. Grouping ABC staff in one location is not a “make do” proposition – it is a strategic imperative. Cross-functional collaboration Abbey Nunes and Betty Klinck work in the newly is necessary to effectively deliver the greatest value to our memrenovated ABC office. bers in alignment with ABC’s strategic plan. The new office configuration uses open space architecture to improve communication and work flow. Cross-functional pods have replaced private offices as the virtual hub of activity. A mixed-use conference room is the epicenter for face-to-face and video-teleconferencing teamwork. The clock is ticking. As the ABC Annual Meeting approaches, ABC members have an important role to play in supporting the financial health of ABC. Not only is this going to be a superb annual meeting, but your vote is needed to approve the proposed bylaw change that adds “hospital-based associate members” as an additional dues-paying category (http://bit.ly/abcamendment). This proposal has the support of your ABC board of directors and the ABC Bylaws, Finance, and Membership Committees. Fortunately there is still time to register (http://bit.ly/1gFccwD). I hope to see you there! E-sig here [email protected] 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 2014 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.) America’s Blood Centers President: Dave Green CEO: Christine S. Zambricki ABC Publications Editor: Betty Klinck Business Manager: Leslie Norwood 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. Send subscription queries to [email protected]. America’s Blood Centers 725 15th St. NW, Suite 700, Washington, DC 20005 Phone: (202) 393-5725 Send news tips to [email protected]. Annual Subscription Rate: $390 ABC Newsletter -3- February 28, 2014 Transfusion in Patients Undergoing PCI (continued from page 1) Ninety-six percent of sites transfused less than five percent of patients and 3.7 percent of sites transfused 5 percent of patients or more. Older patients, females, and those with hypertension, diabetes, advanced renal dysfunction, prior myocardial infarction, or prior heart failure were more likely to receive transfusion. Receiving a transfusion was associated with myocardial infarction (42,803 events; 4.5 percent vs. 1.8 percent; odds ratio [OR], 2.60; 95 percent CI, 2.57-2.63), stroke (5,011 events; 2.0 percent vs. 0.2 percent; OR, 7.72; 95 percent, CI, 7.47-7.98), and in-hospital death (31,885 events; 12.5 percent vs. 1.2 percent; OR, 4.63; 95 percent CI, 4.57-4.69), irrespective of bleeding complications. Within the variation of transfusion practices, “there appeared to be patients who underwent transfusion in the absence of clinical bleeding events and patients who underwent transfusion with nearly normal hemoglobin values,” write the authors. This patient-level data, as well as the finding that transfusions were more common across all hemoglobin values at some hospitals, suggest that thresholds for transfusion may have been driven more by local practice patterns than the patient’s clinical need. The observational study is limited by the potential for unrecognized confounding. The authors conclude, with appropriate conservatism, that inadequate data exists to support transfusion guidelines and thresholds for patients undergoing PCI, notes America’s Blood Centers Executive Vice President, SMT, Louis Katz, MD. “These data highlight the need for randomized trials of transfusion strategies to guide practice in patients undergoing PCI. Until these trials have been completed, operators should use strategies that reduce the risk of bleeding in subsequent transfusion,” conclude the authors. Citation: Sherwood MW, et al. Patterns and outcomes of red blood cell transfusion in patients undergoing percutaneous coronary intervention. JAMA. 2014;311(8):836-843. Advertisement ABC Newsletter -4- February 28, 2014 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. ABC Webinar to Share Results of its 2012 Employee Turnover Survey America’s Blood Centers Human Resources Committee will hold a webinar to review the results of the ABC 2012 Turnover Survey, and to discuss why blood centers should calculate retention, as well as turnover. The webinar will take place on March 13 at 3 p.m. EST. This webinar will review the results of a survey conducted among ABC members in 2013 regarding employee turnover during calendar year 2012. The webinar will also provide an introduction to the 2013 survey, which will be launched next month with the hopes of sharing results in the near future. ABC members can find more information and login details at http://members.americasblood.org/go.cfm?do=FileCenter.View&fid=4765. RESEARCH IN BRIEF A research article published online on Feb. 13 in the Cell Stem Cell journal shows that researchers could potentially grow large quantities of platelets by starting with stem cells. The research, conducted by Koji Eto, MD, PhD, and colleagues of Kyoto University in Japan, improved upon a previously reported method of using induced pluripotent stem (iPS) cells and embryonic stem cells to develop megakaryocytes (the platelet precursor cells in bone marrow) and platelets. In recent years, two research teams, one of them led by Dr. Eto, have produced platelets through these methods but the initial techniques did not produce enough platelets for transfusion. Dr. Eto and colleagues refined their previous technique by prodding human iPS cells and embryonic stem cells with drugs that increased the activity of three genes that prompt the cells to divide and prevent them from dying. This step yielded megakaryocyte precursors, which the researchers found could survive and continue dividing in culture for more than five months, even after being frozen and thawed. When the researchers switched off the three genes by withdrawing the drugs, the cells matured into megakaryocytes and began producing platelets. They report that within an estimated five days, the method can produce enough platelets for a transfusion. The researchers tested the platelets’ efficacy in mice with blood vessel injuries, which showed that the platelets successfully formed clots in the animals. Although the megakaryocytes induced by the team were not as productive as those in bone marrow, growing cells on a large scale could make up for this inefficiency and allow the generation of ample amounts of platelets, Dr. Eto told Science Now, a news blog published by the journal Science. He hopes to begin clinical trials of the lab-produced platelets in two to three years. Experts noted that while these results are exciting, further research is required to demonstrate how the lab-made platelets compare to donated platelets. (Source: Science Now, 2/13/14) Citation: Eto K, et al. Expandable megakaryocyte cell lines enable clinically applicable generation of platelets induced pluripotent stem cells. Cell Stem Cell. 2014 Feb 12. [Epub ahead of print] RESEARCH IN BRIEF (continued on page 5) ABC Newsletter -5- February 28, 2014 RESEARCH IN BRIEF (continued from page 4) Scientists at Massachusetts General Hospital have developed a new optical approach called Laser Speckle Rheology (LSR) for assessing the viscoelastic properties of blood during coagulation by using just a few drops of whole blood. This device could be used to quickly assess a patient’s blood clotting ability in an emergency or operation room setting. In the current study, published Feb. 24 in Biomedical Optics Express, whole blood samples from 50 patients were collected in 3.2 percent citrate blue top tubes for analysis. For each sample, LSR evaluation was performed for 20 minutes to evaluate the entire blood coagulation process. Each sample also underwent conventional coagulation tests (CCT) that included activated partial thromboplastin time (aPTT), prothrombin time (PT), and functional fibrinogen. Clotting times measured using LSR demonstrated a statistically significant positive correlation with aPTT (r-value = 0.73, p < 0.001) as well as with PT (r-value = 0.69, p < 0.001). Furthermore, in a subset of 25 samples, the maximum clot stiffness measured by LSR showed a close correlation with functional fibrinogen levels (r-value = 0.68, p < 0.001). The authors conclude that the results demonstrate the utility of LSR for blood coagulation assessment in real-time. An additional advantage of LSR over CCT tests is that LSR tests can be conducted on whole blood, which more closely resembles the in vivo hemostasis process, while CCTs are conducted on plasma. The LSR system also provided coagulation results in < 10 minutes, much faster than is typically possible with CCTs. Since the LSR required only a few drops of blood, it may be implemented in the future using a simple finger prick blood test, reducing the need for excess blood draws that may increase the risk of iatrogenic anemia. The illumination and detection mechanism of LSR can be miniaturized to fabricate a hand-held device for point-of-care or home use. Other viscoelastic tests such as thromboelastography (TEG) and rotational thromboelastometry (ROTEM) are large instruments that are difficult to operate and require specialized operators and training; interpreting results can be challenging, said Richard Gammon, MD, medical director at OneBlood, who was not involved in this study. “These limitations have restricted the clinical adoption of TEG and ROTEM at the bedside. In the future, a hand-held LSR instrument for coagulation assessment may serve as a powerful tool for detecting bleeding and thrombotic conditions, optimizing treatment or blood transfusion protocols, and monitoring anticoagulation therapy at the patient’s bedside,” said Dr. Gammon. Citation: Tripathi MM, et al. Biomed Opt Express 2014 Feb 24;5:817-831. Taiwanese researchers identify an association between iron-deficiency anemia (IDA) and ischemic stroke. Anemia is associated with cardiovascular disease and stroke. While the link between sickle cell anemia and stroke has been well-researched, little is known about whether non-sickle cell anemia is related to ischemic stroke. The researchers conducted a case-control study for which subjects were obtained from the nationwide Taiwanese Longitudinal Health Insurance Database 2000. They included 51,093 subjects with stroke and 153,279 randomly selected controls. Odds ratios (ORs) for previously diagnosed iron deficiency were calculated. Of 3,865 subjects (1.8 percent) with IDA prior to the study date, 1,268 (2.5 percent) were stroke patients and 2,417 (1.6 percent) were controls. The OR was 1.49 (95 percent confidence interval: 1.39-1.58) for stroke victims compared to controls, after adjusting for monthly income, geographic region, hypertension, diabetes, coronary heart disease, atrial fibrillation, heart failure, hyperlipidemia, tobacco use disorder, and alcohol abuse. IDA could be a risk factor for ischemic stroke because a decrease of the hemoglobin level in the blood stream may compromise tissue oxygen delivery, suggest the authors. Another mechanism that may explain an association between IDA and stroke is the secondary thrombocytosis of iron deficiency, said the authors. They note that a limitation of their study is that health insurance database analyses may have surveillance bias. “This study demonstrated an association between IDA and ischemic stroke. Although the casual relationship between IDA and ischemic stroke remains to be further investigated, we recommend that patients found to have IDA should be more (continued on page 6) ABC Newsletter -6- February 28, 2014 RESEARCH IN BRIEF (continued from page 5) aggressively surveyed and managed for the possible underlying bleeding source and/or iron deficiency status in order to reduce the risk of subsequent ischemic stroke,” concluded the authors. Citation: Chung SD, et al. Association between ischemic stroke and iron-deficiency anemia: a population-based study. PLoS One. 2013 Dec 9;8(12):e82952. BRIEFLY NOTED Global Blood Fund (GBF) and the African Society for Blood Transfusion (AfSBT) are collaborating on a new project to launch March 1 that seeks to share narratives from African blood bankers with other parts of the world. Blood bankers and physicians in Africa overcame significant obstacles to providing a safe and adequate blood supply daily. “Here there are powerful stories that could help transform global industry understanding of blood banking issues in low-income countries, influencing our collective willingness to confront inequalities. But for the most part, these stories remain untold,” said GBF in a recent press release. In an effort to unlock this hidden narrative, GBF, a non-profit US and UK organization that seeks to improve blood safety and availability in developing countries, and AfSBT, representing blood service professionals in Africa, are launching an online international story competition. “The Wonder of Blood – Saving Lives in Africa” aims to give everyone with a story to tell the chance to share it with the rest of the world – and for the best story-teller to be rewarded with a cash prize. “Stories are incredibly powerful tools in transforming understanding of others’ reality,” said GBF Executive Director Gavin Evans. “Our collaboration with AfSBT gives everyone with experiences to share an opportunity to do so and will help build a rich repository of material, both written and photographic. This will be used to communicate the key issues faced by donors and professionals in Africa and help elicit broader understanding and support.” The contest opens March 1 and will run for two months. The outcomes from this initiative are expected to be shared at AfSBT’s 7th International Congress in Victoria Falls, Zimbabwe, from July 20 to Aug. 2. “Working with GBF has allowed us to engage our members in new and innovative ways,” said AfSBT Secretary General Isaac Kajja, MD. “Through this latest collaboration, stories previously recounted only to intimate circles of colleagues and family in a given poorly accessible country or region can now be shared with the global blood banking community. The link to submit entries will become active on March 1 and can be accessed at http://review.wizehive.com/contests/gbf-afsbt-contest. (Source: GBF press release, 2/26/14) REGULATORY NEWS The Food and Drug Administration released on Feb. 10 a guidance for industry and FDA staff titled “Annual Reports for Approved Premarket Approval Applications (PMA).” Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act are subject to periodic reporting requirements set forth in the PMA approval order, 21 CFR 814.84(b). This guidance describes the information required to be submitted in annual reports under 21 CFR 814.84(b); additional information requirements that may be imposed under 21 CFR 814.82(a); and FDA’s recommendations for the level of detail the applicant should provide in the annual report. The document also details the steps FDA staff generally take when reviewing annual reports, resources available to assist staff in their reviews, and actions that may be recommended after reviewing annual reports. The guidance can be accessed at http://1.usa.gov/1ftLUAW. (Source: FDA guidance, 2/10/14) REGULATORY NEWS (continued on page 7) ABC Newsletter -7- February 28, 2014 REGULATORY NEWS (continued from page 6) AABB announced in last week’s AABB Weekly Report that its Standards for Blood Banks and Transfusion Services, 29th edition, is now available for pre-order. The new standards become effective on April 1 and include significant changes, particularly new transfusion-related acute lung injury (TRALI) mitigation strategies. The latest edition also adds standards for the preparation of two components: Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature up to 24 Hours After Phlebotomy and Apheresis Platelets, Platelet Additive Solution Added Leukocytes Reduced. The Standards can be ordered at http://bit.ly/1lnIrpS. (Source: AABB Weekly Report, 2/21/14) Biotest Pharmaceuticals Corp. initiated a voluntary recall of certain lot numbers of its BIVGAM (Immune Globulin Intravenous (Human) 10 percent Liquid), 100 mL, announced the Food and Drug Administration on Feb. 24. The recall is due to the potential that a very small percentage of the vials may exhibit an integrity defect. In the rare event that a vial is affected, the defect could potentially result in leakage. Biotest Pharmaceuticals is taking this action as a precautionary measure in the interest of patient safety because the defect may not be readily apparent when the end user prepares the product for administration. Those who have received the noted lot numbers are asked to quarantine all vials and communicate with Biotest Pharmaceuticals to arrange for product return. For more information and the affected lot numbers, visit http://1.usa.gov/Mzs4Y4. (Source: FDA Vaccine, Blood & Biologics Recalls page, 2/24/14) The Department of Health and Human Services announced in a Feb. 12 Federal Register notice that the Office of the Assistant Secretary for Health is seeking nominations of qualified members (continued on page 8) ABC Newsletter -8- February 28, 2014 REGULATORY NEWS (continued from page 7) of the public to serve on the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is the federal advisory committee within HHS that provides advice to the Secretary and Assistant Secretary for Health regarding public health, ethical, safety, and legal issues relating to blood and blood products and transfusion. The committee consists of 23 voting members; 14 public members; and nine individuals designated to serve as official representative members. Persons nominated for appointment to the committee should be among authorities knowledgeable in tissue banking, tissue transplantation, tissue/organ transplant safety, blood banking, transfusion medicine, plasma therapies, transfusion safety, bioethics, and/or related disciplines. All nominations must be sent by 4 p.m. EST on March 7 to James Berger, senior advisor for Blood and Tissue Safety Policy at the Office of the Assistant Secretary of Health, HHS; 1101 Wootton Parkway, Ste. 250; Rockville, MD 20852. Mr. Berger may also be reached at (240) 453-8803. More information is available at http://1.usa.gov/1o9nUCn. (Source: Federal Register, 2/12/14) THE WORD IN WASHINGTON The House Ways and Means Committee Chairman Dave Camp (R-MI) unveiled on Feb. 21 his draft tax reform legislation, which includes a full repeal of the medical device tax. Under the 2.3 percent medical device tax, mandated by the Affordable Care Act, device manufacturers are required to pay an estimated average of $194 million per month in medical device payments. Details regarding the proposed tax reform legislation and a link to the bill can be found at http://1.usa.gov/1bMooy7. Just last week, the Advanced Medical Technology Association (AdvaMed) published the results of a survey among its members showing that during its first year of implementation, the medical device tax has led to employment reductions of about 14,000 industry workers and foregone hiring of more than 19,000 workers. Earlier this week, Minnesota legislators urged President Obama to repeal the medical device tax, prior to his visit to St. Paul Minn. to discuss the economy. Minnesota is home to hundreds of medical device companies that employ more than 30,000 people. “The medical device tax hits smaller companies hardest. Because of the heavy investment in research and development and the long regulatory and approval process required to develop a life-saving device, it takes many companies close to a decade to become profitable, yet they are required to pay this excise tax on their gross revenue, not profit,” said Rep. Erik Paulsen (R-MN) in his letter to Pres. Obama. US Sens. Amy Klobuchar (D-MN) and Al Franken (D-MN) have both urged their colleagues to repeal the tax. Rep. Paulsen’s letter to President Obama can be viewed at http://bit.ly/1fIjqBS. (Sources: Tax Reform Act of 2014, 2/21/14; StarTribune, 2/24/14) This week, America’s Blood Centers CEO Christine Zambricki, DNAP, CRNA, FAAN, met with US Rep. Sam Farr (D-CA) to discuss the role of ABC members in providing blood services in the US and Canada. Dr. Zambricki also acquainted Rep. Farr with the interests and issues of ABC members. Rep. Farr is a member of the House Appropriations Committee, which controls the purse strings of the federal government. It is an exclusive committee, meaning that its members are not allowed membership on other committees. Most important to ABC members, Rep. Farr is the ranking member of the Agriculture, Development, and Food and Drug Administration Subcommittee. This subcommittee has legislative jurisdiction over FDA. ABC Newsletter -9- February 28, 2014 GLOBAL NEWS The Finnish Medicines Agency increased the upper age limit of blood donors from 65 to 70 years old, allowing the Finnish Red Cross Blood Service to begin collecting from these donors as of Feb. 10. Based on a literature review, data on experiences in other countries, and statistics on donor adverse reactions and deferrals by age groups, the Finnish Medicines Agency deemed this change to be safe for donors. After careful consideration and consultation with authorities from the EU member states and the EU Commission, the agency decided to accept blood donations from donors up to 70 years old at the discretion of the responsible physician through a systematic approach based on appropriate risk assessment. Because the change is not stated in the new blood donation regulations issued by the Finnish Medicines Agency in June 2013, the responsible physician of the blood donors at the Finnish Red Cross Blood Service must prepare an annual risk assessment and ask for a written authorization from the regulator to collect blood from ages 66 to 70. The new age limit is expected to increase the amount of blood donations by 3 to 4 percent. In its first week of implementation, 6 percent of donors were between ages 66 and 70. (Source: EBA Newsletter, 2/20/14) ABC Newsletter -10- February 28, 2014 INFECTIOUS DISEASE UPDATES CHIKUNGUNYA The Centers for Disease Control and Prevention held a webinar on Feb. 18 titled “Chikungunya Virus – An Emerging Threat to the Americas” as part of its Clinician Outreach and Communication Activity (COCA) conferences. Outbreaks of chikungunya virus, a mosquito-borne virus, have occurred in parts of Africa, Asia, Europe, and the Indian and Pacific Oceans. In late 2013, the first local chikungunya virus transmission in the Americas was reported on the islands in the Caribbean. Travelers to areas with ongoing outbreaks are at risk of becoming infected and spreading the virus to new areas, including the US. During the webinar, J. Erin Staples, MD, PhD, a medical epidemiologist at CDC’s National Center for Emerging and Zoonotic Infectious Diseases, described chikungunya virus epidemiology, clinical findings, diagnosis, treatment, and prevention. She also discussed the importance of early recognition and reporting suspected cases to mitigate the risk of local transmission. In response to a question from a blood banker, Dr. Staples noted that the Caribbean strain of the virus is related to the Asian strain of Chikungunya that does not share a mutation in the African virus, which means that the Aedes albopictus mosquito is an efficient vector, in addition to Aedes aegypti. That suggests that if and when it establishes itself in the mainland, it may remain relatively confined to southern states where Aedes aegypti is present. The presentation slides and audio can be found at http://1.usa.gov/1fX64OD. The AABB Emerging Infectious Diseases (EID) subgroup of the AABB Transfusion Transmitted Diseases Committee is currently working on an updated version of the chikungunya virus fact-sheet to reflect the risk of disease transmission within the Caribbean and US, said ABC Executive Vice President, SMT, Louis Katz, MD, who chairs the AABB TTD Committee. Transfusion transmission of the virus has not been demonstrated, he added, but there is an asymptomatic period that the virus is present in blood and it can be transmitted by this route in a primate model. (Source: COCA conference, 2/18/14) HEPATITIS B VIRUS The US Preventive Services Task Force (USPSTF) recently proposed new recommendations that adults at high risk for hepatitis B virus (HBV) be screened for the virus. Although most people born in the US are vaccinated against HBV, there are still nearly 1 million infected people in the US. Of those with chronic HBV, 15 to 25 percent die from serious liver disease or liver cancer. Based on a review of existing evidence, the task force concluded that the following people should be screened for HBV: Anyone born in countries or regions with a high rate of HBV, including Africa, Southwest Asia, the Middle East, Eastern Europe, and northern countries in South America; People born in the US who were not vaccinated against HBV in infancy whose parents were born in areas with a high rate of HBV; IV drug users; Gay and bisexual men; People with a weak immune system; Those undergoing treatment for kidney failure. Vaccination remains the best way to prevent HBV infection, stated the task force. Public comments on the draft proposal are being accepted until March 11. The proposed guidelines and directions to comment can be found at http://bit.ly/1faPpXz. ABC Newsletter -11- February 28, 2014 STOPLIGHT®: Status of America’s Blood Centers’ Blood Supply Percent of Regional Inventory at 2 Days Supply or Less, February 26, 2014 Total ABC Red Cell Inventory 7% 11% 9% 4% 14% 36% 36% 43% 47% 36% 9% 45% 11% 4% 47% 42% 44% 39% 38% 1 9% 64 % 38% 46% 0% 3 0% 18 % 10% 8% 9% 9% 10% Ea s t 9% 22-Jan 29-Jan 5-Feb 12-Feb 19-Feb 26-Feb No Report Green (3 days or more) Yellow (2 days) Red (1 day or less) M id w e st S o u th W e st Percent of Total ABC Blood Supply Contributed by Each Region East: 20%; Midwest: 25%; South: 24%; West: 31% Daily Updates are available at: www.AmericasBlood.org MEMBER NEWS Héma-Québec inaugurated its Quartier DIX30 Globule Blood Donor Center on Feb. 12, announced the center in a press release. The new Globule Center offers people living in the Montérégie region a complementary option to the mobile blood drives to donate blood. Donors in the region are invited to make a donation during any day of the week with or without an appointment. “The Montérégie is a crucial region for Héma-Québec, with a large pool of active blood donors,” explained Jean De Serres, MD, president and CEO of Héma-Québec. “In Québec, one donor in five comes from the Montérégie. The Quartier DIX30 Globule Center will enable Héma-Québec to continue responding to the hospitals’ demand by collecting products that are targeted according to the needs of Québecers.” The Globule Blood Donor Center allows donors to give more frequently and to make various types of donations including whole blood, platelets, plasma, and red blood cells. The Globule model complements the mobile blood drives. In Québec, 81 percent of blood donations are made at mobile blood drives, 13 percent at a Globule Center, and 6 percent in a mobile unit. Héma-Québec operates three other Globule Blood Donor Centers throughout its service area, which welcome on average 1,500 donors per week. (Source: Héma-Québec, 2/12/14) MEMBER NEWS (continued on page 12) ABC Newsletter -12- February 28, 2014 MEMBER NEWS (continued from page 11) OneBlood recognized American Heart Month throughout the month of February by highlighting wellness tests offered by the blood center and the importance of early screening to prevent and control heart disease. “Since all blood donors receive a free blood pressure check and cholesterol screening, one altruistic way to lead a healthy heart lifestyle is by regularly giving blood,” said OneBlood in a press release. All donors who gave blood during the month of February received an “Am I Your Type?” T-shirt and a wellness checkup, which includes blood pressure, temperature, iron count, and cholesterol screening. OneBlood shared the story of Randy Bragg who underwent two heart transplantations, both operations requiring multiple units of donated blood. Mr. Bragg’s story can be viewed at http://bit.ly/OHGgjL. (Source: OneBlood press release, 2/21/14) PEOPLE David Fennell, recently announced that he will retire from his role as chief operating officer (COO) and chief information officer (CIO) at Puget Sound Blood Center (PSBC), headquartered in Seattle, Wash. “Dave applied his business leadership experience and expertise to create management systems that position us for success as a quality-driven, results-focused, and economically sustainable organization,” said James P. AuBuchon, MD, PSBC president and CEO. Before joining PSBC in 2010, Mr. Fennell spent 28 years at Boeing Commercial Airplanes – including five years as CIO and vice president of Boeing Information Technology. He also served for three years as CIO at the Bill and Melinda Gates Foundation. Linda Barnes will succeed Mr. Fennell in the combined role of chief operating officer and CIO, overseeing all operating and business lines including blood components, donor testing, transfusion services, hemophilia and patient services, specialty diagnostic labs, and cord blood. “In addition to deep knowledge about quality systems and regulatory affairs, Linda brings a wealth of business leadership experience acquired during a global operations role with Dendreon Corporation, as director of diagnostic and treatment services at Seattle Cancer Care Alliance, and through management of complex clinical trial structures,” said Dr. AuBuchon. PSBC is also beginning a nationwide search for a new chief quality officer (CQO). In the meantime, Ryan Milburn, currently the director of quality assurance and regulatory affairs, will serve as acting CQO. (Source: PSBC press release, 2/24/14) CORRECTIONS In last week’s ABC Newsletter, we ran an article on page 6 titled “ABC Leaders Work on Redesigning ABC” in which a photo caption contained the incorrect title for Nelson Hellwig of Mississippi Valley Regional Blood Center. His title should be vice president and chief financial officer. Also on page 7, we accidently listed “Education/Competency Development” twice within the numbered list of key elements of ABC’s new strategic plan. We apologize for these errors and thank our readers who bring these issues to our attention. ABC Newsletter -13- February 28, 2014 COMPANY NEWS Mediware Information Systems, Inc., and Cytolon AG agreed to collaborate on improving IT tools for banking and matching of hematopoietic stem cells derived from umbilical cord blood donations, Mediware announced in a Feb. 13 press release. Mediware and Cytolon AG will work together to ensure that cord blood bank IT systems enable patients to receive the best human leukocyte antigen (HLA) match available. Cytolon AG’s internet-based platform, CordMatch, matches cord blood units globally to allow for secure and cost-free communication between clinicans and coordinators with the umbilical cord blood product providers. The platform enables immediate and comprehensive search of all data on registered cord blood based on the clinican’s protocol, and provides reports on relevant stem cell products in real-time for informed decision making. CordMatch is a patented Class 1 medical device registered in both Europe and the US. The new collaboration will bring greater connectivity to cord blood banks already using Mediware’s existing cord blood banking software and will expand Cytolon’s customer base and increase the number of cord blood units listed for transplant. The Transtem software by Mediware provides process management from online donor registration and account creation, through product collection, manufacturing, storage, testing, label generation, and release – all in one system. Together, CordMatch and Transtem will provide an enhanced user experience for listing, searching, and selecting cord blood products for transplantation, while increasing efficiency and safety, said the release. More information can be found in the Mediware press release http://bit.ly/1fXqOpn. (Source: Mediware, 2/13/14) MEETINGS March 6 The 17th US-Japan Cellular and Gene Therapy Conference, Bethesda, Md. The Food and Drug Administration will hold the 17th US-Japan Cellular and Gene Therapy Conference on “Chimeric Antigen Receptor T Cells for Cancer Therapy” at the Natcher Conference Center in Bethesda, Md. on March 6. This conference is jointly organized by FDA’s Center for Biologics Evaluation and Research, FDA, and Japan’s Ministry of Education, Culture, Sports, Science and Technology, under the US-Japan Cooperative Research Program. The goal of the conference is to exchange ideas on cutting edge areas of biomedical research and to enhance opportunities for collaborations among scientists from Japan and the US. There is no registration prior to the event, but seating is limited to 150 attendees on a first-come-first-serve basis. More information can be found at http://1.usa.gov/1eG0UFU. March 18-19 FDA Blood Products Advisory Committee Meeting, Silver Spring, Md. FDA is holding a meeting of its Blood Products Advisory Committee at its White Oak Campus in Silver Spring, Md. on March 18 from 8:30 a.m. to 4:30 p.m. and on March 19 from 9 a.m. to 11:30 a.m. On March 18, the committee will discuss the evaluation of the safety and effectiveness of the Immucor PreciseType HEA Molecular BeadChip Assay, manufactured by BioArray Solutions Limited. In the afternoon the committee will hear updates on recent meetings. On March 19, the committee will meet in open session to hear presentations on the research programs of the Laboratory Hemostasis, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research. More information is available at http://1.usa.gov/1d1Em5X. ABC Newsletter -14- February 28, 2014 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 $279 for non-subscribers. A six (6) percent processing fee will be applied to all credit card payments. 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: Associate Medical Directors. BioBridge Global (BBG) and its subsidiaries (South Texas Blood & Tissue Center, Gencure, and QualTex) are seeking two associate medical directors for locations in San Antonio, Texas and Norcross, Ga. Reporting to the Medical Directors, responsible for establishing medical procedures to ensure optimal medical care and regulatory compliance. This includes medical oversight of research, clinical consultation, medical client support, autologous/directed donations, cord blood collections, and counseling. Will provide medical support to blood/components, laboratory testing, product management, clinical diagnostics, and QA. Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) required. Must be licensed or license eligible to practice medicine in the State of Texas, Georgia, & New York. Board certified in clinical pathology or hematology required. Blood banking/transfusion medicine board certification or board eligible. For more information, please visit our website at www.biobridgeglobal.org or contact Maria Garcia-Andrade, HR Generalist @ (800) 292-5534, Ext. 1852. Email resume to [email protected]. EOE-AA. Reference Lab Medical Technologist (St. Petersburg, FL). Hours: 3rd Shift; 11 p.m. - 7:30 a.m.; SundayThursday; Rotating weekends and holidays as needed. SBB experience preferred, but not required. Red Cell/White Cell genotyping preferred, but not required. Performs basic through advanced testing procedures on patient and/or donor samples and interprets results in accordance with regulatory guidelines and organizational policies and procedures. Applicant must have a bachelor’s degree in a biological science or related scientific field from an accredited college or university or an equivalent combination of education, certification, training and/or experience. Applicant also must have a valid and current Florida Clinical Laboratory Technologist license in Immunohematology or Blood Banking. In certain specialty laboratories performing HLA, molecular testing or patient testing, other Florida licenses may be required. To apply and to view a complete job description of this position, go to www.oneblood.org and click on the “Careers/Volunteer” link at the bottom of the page. Then click on “Career Opportunities.” OneBlood, Inc. is an Equal Opportunity Employer. In compliance with United States Equal Employment Opportunity guidelines and the Americans with Disabilities Act, OneBlood, Inc. provides reasonable accommodation to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Reference Laboratory Technologist. Community Blood Services has an exciting opportunity in our Montvale, N.J. facility for a FT reference laboratory technologist performing antibody testing, antigen typing, and providing consultation to hospital staff as needed. The schedule is Monday-Friday 12 p.m. to 8 p.m., including on-call rotation for nights, weekends, and holidays. Candidates are encouraged who possess MT/MLS certification with ASCP or equivalent. SBB a plus, but not required. Ideally, candidates will have two years of blood banking experience in the past five years. EOE. Interested candidates may visit: https://home.eease.com/recruit/?id=8101851 Region Recruitment Manager. Puget Sound Blood Center is seeking a strategic leader to manage the departments responsible for donor group and volunteer recruitment goals. Responsibilities include: providing leadership and motivation to staff teams; developing systems and program analysis tools; improving communications enhancing community relationships to encourage donor and volunteer participation; positioning the Blood Program as a volunteer supported organization. Ideal candidates will have over eight years’ direct experience in recruitment, marketing, customer relationship management, or volunteer management experience, and five years in a supervisory capacity. Requirements also include demonstrated familiarity with marketing and planning systems; strong data analysis skills; demonstrated written, verbal and interpersonal communication skills; and proficiency with Windows PC software. Bachelor’s degree in a related field or equivalent work experience. Blood recruitment industry experience preferred. This exempt, full-time position is based in Bellevue, WA. Submit resume to Puget Sound Blood Center via email at [email protected]; fax: 1-866-286-8495; USPS: Human Resources, Puget Sound Blood Center, (continued on page 15) ABC Newsletter POSITIONS (continued from page 14) 921 Terry Avenue, Seattle, WA 98104-1256. Reference Job #7032. Open until filled. For disability/accommodation assistance with the application process contact HR at [email protected], or at (206) 292-6500, or at 921 Terry Avenue, Seattle, WA 98104. AA.EOE. Cord Blood Manager, Processing and Distribution. LifeSouth Community Blood Centers is currently seeking an experienced professional for the cord blood manager, processing and distribution position in Gainesville, Fla. This position manages cord blood processing, storage and distribution. Responsibilities include, but are not limited to: manage the cord blood processing area, processing activities and record review process to ensure functionality and timely record turnaround; assist and manage the initiation of new cord blood collecting sites; oversee hiring cord blood processing staff; plan, assign and direct work of cord blood processing staff and routinely appraise performance; respond to audit/inspection findings; and represent and communicate LifeCord and LifeSouth favorably to the public and to the participating institutions. Bachelor’s degree in science related-field required. Four to 10 years related experience and/or training may replace education requirements. Willingness and ability to travel is required. This is a full-time position. Starting salary range is $50,000 - $55,000 annually. Background check and drug test required. Equal Opportunity/Affirmative Action Employer/DFWP/Tobacco Free. Click on the link to apply: https://lifesouth.csod.com/ats/careersite/JobDetails.aspx ?id=28. Hospital Services Manager. The Blood & Tissue Center of Central Texas in Austin is seeking a manager for the Hospital Services Inventory Management department who has solid knowledge in blood product management and inventory control. This position will oversee department operations and staff, ensure compliance with applicable regulations, as well as serve as a subject matter expert; evaluate inventory and projections daily to ensure sufficient quantity and variety of prod- -15- February 28, 2014 ucts; maintain adequate operational supply levels; project production usage/needs and establish daily and long-range product levels for service area; maintain inventory expirations; and manage resource sharing of blood products to meet goals. At least four years production and process control experience in a biologic or GMP environment is required, preferably in a blood center, with a minimum of four years of supervisory experience. College degree in Clinical Laboratory Science is required. At least two years of inventory control experience in a hospital blood bank/center setting preferred. Must have knowledge of cGMP requirements and FDA regulations. Must be at least 21 years old, hold a valid driver’s license, be able to provide a copy of an acceptable driving record and proof of liability insurance. Please visit www.inyourhands.org to apply. IRL Clinical Lab Manager. Blood Systems Laboratories is searching for a Clinical Lab Manager to assist its busy Immunohematology Reference laboratory (IRL) in Phoenix, Ariz.! The successful candidate must be highly organized, able to multi-task in a busy office environment, as well as work successfully in a team environment. Responsibilities will include managing the overall activities and providing skilled technical oversight in the laboratory. This position will work with other team members to ensure timely, quality, test results. Requires: Bachelor’s degree, must satisfy CLIA requirements for High Complexity Testing, SBB or CHS certification, seven years clinical laboratory experience to include three years supervisory experience. For consideration, please submit resume via e-mail by ATTN: 03/07/2014 to: [email protected] HR/2014/12. BSI offers a competitive benefits package including: affordable medical/vision/dental coverage, matched 401(k), education assistance, relocation and much more! Pre-employment background check and drug screen is required. For more information about this position, please visit our website at: www.bloodsystems.org. EOE M/F/D/V. Find the Hero In You. Give Blood Three Times a Year! ABC Newsletter -16- February 28, 2014 CALENDAR Note to subscribers: Submissions for a free listing in this calendar (published in the last issue of each month) are welcome. Send information to Leslie Norwood by e-mail ([email protected]) or by fax to (202) 3935527. (For a more detailed announcement in the weekly “Meetings” section of the Newsletter, please include program information.) 2014 Mar. 20-21. FTC Public Workshop: Examining Health Care Competition, Washington, D.C. More information and registration details can be found at http://1.usa.gov/1kHU4Yd. Mar. 22. 4th Annual Links for Life Golf Tournament, Desert Willow Golf Course, Palm Springs, Calif. Contact: Abbey Nunes. Phone: (202) 654-2980; e-mail: [email protected]. Mar. 22-25. Annual Meeting, America’s Blood Centers, Palm Springs, Calif. Contact: ABC Meetings Dept. Phone: (202) 654-2901; e-mail: [email protected]. Mar. 26-28. Mayo Clinic TransFuse 2014, Phoenix, Ariz. More information and registration details can be found at http://mayocl.in/1fwOU9Q. Mar. 31. FDA Public Workshop: Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products, Silver Spring, Md. More information is available at http://1.usa.gov/1hBEXzw. Apr. 29-May 1. Human Resources/Training & Development Workshop, America’s Blood Centers, Houston, Texas. Contact: ABC Meetings Dept. Phone (202) 654-2901; e-mail: [email protected]. May. Specialist in Blood Bank (SBB) Program. Gulf Coast Regional Blood Center in Houston, Texas is accepting applications for its 12-month distance program. Application deadline is January 15 for the May 2014 class. Program details: http://bit.ly/1ftZouy. Contact Clare Wong, (713) 791-6201, [email protected]. May 11-15. WFH 2014 World Congress, Melbourne, Australia. For more information and to register, visit http://bit.ly/1227maC. May 21-22. IPFA/PEI 21st International Workshop on Surveillance and Screening of Blood Borne Pathogens, Rome, Italy. More information can be found at www.ipfa.nl. May 31-June 5. 3rd International Congress of the ISBT, Seoul, South Korea. For more information please visit: www.isbtweb.org/seoul. June 5-8. 5th International Monoclonal Antibody Workshop, New York, N.Y. Contact: Gregory Halverson, New York Blood Center. Phone: (212) 570-3026; e-mail: [email protected]. June 17-20. Fund Development, Communications, and Donor Management Workshop, America’s Blood Centers, Sacramento, Calif. Contact: ABC Meetings Dept. Phone (202) 654-2901; e-mail: [email protected]. Aug. 5 Tuesday (note: new date and day). Medical Directors Workshop, America’s Blood Centers, Seattle, Wash. Contact: ABC Meetings Dept. Phone: (202) 654-2901; e-mail: [email protected]. Aug. 6-7 Wednesday-Thursday (note: new dates and days). Summer Meeting, America’s Blood Centers, Seattle, Wash. Contact: ABC Meetings Dept. Phone: (202) 654-2901; e-mail: [email protected]. Sept. 16-17. IT Workshop, America’s Blood Centers, Indianapolis, Ind. Contact: ABC Meetings Dept. Phone: (202) 654-2901; e-mail: [email protected]. Sept. 23-24. IPFA/BCA Global Symposium on the Future for Blood and Plasma Donations, Sacramento, Calif. More information and registration details can be found at http://bit.ly/1fDqJrX. Oct. 25-28. AABB Annual Meeting and CTTXPO, Philadelphia, Pa. For more information: http://bit.ly/MC1i1l. Oct. 31-Nov. 3. 5th International Meeting on Emerging Diseases and Surveillance, Vienna, Austria. More information can be found at http://imed.isid.org. Contact: [email protected]. Dec 9-10. Supply Chain Optimization Workshop, America’s Blood Centers, Austin, Texas. Contact: ABC Meetings Dept. Phone: (202) 654-2901; e-mail: [email protected].
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