PRELIMINARY PROGRAM Updated 9/8/2016. Information subject to change. THURSDAY, OCTOBER 20, 2016 8:30 a.m. - 5:00 p.m. New Assessor Training Event Description: The session is designed for current AABB assessor and all who complete the training will receive a Certificate of Completion. An approved assessor application must be on file before you can register for this course. If you are interested in becoming an AABB assessor, please email accreditation@aabb.org 10:00 a.m. – 3:00 p.m. ASQ Certification Exam 1:30 p.m. - 5:00 p.m. (HEMO) Introduction to Hemovigilance Workshop Director: Barbee Whitaker, PhD Moderator: Jeannie Callum, MD, BA, FRCPC, CTBS Speaker: Salvadore Rico; C. Palani Palaniappan; Manette Niu, MD; Misha Baker, MPH; Jeannie Callum, MD, BA, FRCPC, CTBS; Barbee Whitaker, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Learn how Hemovigilance is practiced in the US and how hospitals can participate. Follow the practical steps to enter records into the CDC NHSN Hemovigilance Module. Discuss what has been learned from hemovigilance programs globally and how these lessons can be implemented locally to improve transfusion safety patient outcomes in your hospital. Explore the use of hemovigilance data in the development and implementation of innovations in blood safety and how these hemovigilance can be used to enhance your quality system. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 1 Event Description: This workshop provides an opportunity for attendees to obtain a comprehensive view of hemovigilance in the US, including regulatory requirements from FDA, the voluntary CDC National Healthcare Safety Network Hemovigilance Module and the AABB Center for Patient Safety. Learn what it takes to participate and how you and your hospital can benefit from participation. FRIDAY, OCTOBER 21, 2016 8:00 a.m. - 5:30 p.m. (1002) Patient Blood Management Workshop Director: Barbara Bryant, MD, MT(ASCP)SBB Speaker: Jonathan Waters, MD; Mark Friedman, DO; Courtney McClellan; John Hess, MD, MPH, FACP, FAAAS; Mark Yazer, MD; Michael Auerbach Intended Audience: Physicians, Technologists, Nurses Teaching level: Intermediate to Advanced Event Description: Patient Blood Management (PBM) plays a vital role in health care decisions and offers a solution to a number of current healthcare challenges. Come learn how a successful approach to PBM can improve patient care and how PBM plays an essential role in bringing optimal care across different disciplines and service lines. This workshop will help you understand the role of PBM today as the new standard of care and how it will continue to evolve and improve patient care in the future. 8:30 a.m. - 5:00 p.m. (99) Assessor Continuing Education Program Director: Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ) Assessor Speaker: Eva Quinley, MS, MT(ASCP)SBB, CQA(ASQ); Meredith Reyes, MD; Kelley Capocelli, MD; Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ); Maureen Beaton, MT(ASCP)BB, CQA(ASQ); Chelsea Nieuwenkamp, MLS(ASCP) Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, Perfusionists Objectives: 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 2 Recognize assessment road blocks and determine how to successfully overcome them. Gain knowledge and understanding of the new Accreditation database and its use. List ways and tactics to effectively manage teams, handle conflict and provide superior customer service. Describe how recent changes in the blood bank community affect the assessor’s role in the accreditation process. Event Description: The Assessor Continuing Education program session is designed as a continuing education course for current AABB assessors. This program with showcase and recognize barriers and how to successfully conquer them. The learner will also obtain new information on Accreditation and improved ways to engage and lead their counter parts in the same efforts. An approved assessor application must be obtained prior to course register. If you are interested in becoming an AABB assessor, please email accreditation@aabb.org Event Level: Intermediate 5:30 p.m. - 7:00 p.m. Cellular Therapy Networking Reception Patient Blood Management Workshop Showcase Reception 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 3 SATURDAY, OCTOBER 22, 2016 8:30 am – 10:00 am Opening General Session 10:30 a.m. - 12:00 p.m. (9101-S-CT) Antigen-Specific T Cells: Progress and Challenges Director/Moderator: Yvette Tanhehco, PhD, MD, MS Speaker: Pawel Muranski, MD; David Stroncek, MD Intended Audience: Physicians, Scientists, Technologists Teaching level: Basic to Intermediate Objectives: Discuss the efficacy and limitations of virus and fungus-specific T cell therapy for hematopoietic stem cell transplant recipients. Discuss the current state of antigen-specific T cell therapy for non-viral cancers. Discuss the process and regulatory requirements for manufacturing antigen-specific T cells. Event Description: Adoptive immunotherapy with antigen-specific T cells has been gaining traction over the past few years because of many potential benefits as a treatment for virus-associated diseases and malignancies. Viral and fungal infections are a major cause of morbidity and mortality in immunocompromised patients such as hematopoietic stem cell transplant recipients. Pharmacologic treatments are available for patients with some types of viral infections, but these often have limited efficacy and significant adverse effects. Since antigen-specific T cells have shown significant activity against virus-associated tumors, this strategy is also being explored for the treatment of non-viral cancers. This session will discuss the progress and challenges associated with antigen-specific T cell therapy of virus-associated diseases and malignancies. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 4 (9102-S) Mechanisms of Hemolysis-Driven Vascular and Immune Reactivity in Hemolytic Diseases Director/Moderator: Karina Yazdanbakhsh, PhD Speaker: Gregory Vercellotti, MD; Mark Gladwin, MD; Karina Yazdanbakhsh, PhD Intended Audience: Physicians, Scientists Teaching level: Intermediate to Advanced Objectives: To discuss recent insights into mechanisms hemolysis-driven vascular dysfunction in patients with sickle cell disease and the effect of acute and chronic transfusions. To describe molecular pathways of hemolysis-associated inflammation. To discuss innate and adaptive response to hemolysis in transfused patients with sickle cell disease and impact on alloimmunization. Event Description: Free hemoglobin and its reactive iron protoporphyrin group (heme) released during intravascular hemolysis has deleterious effects on the vasculature in part through oxidative damage and depletion of nitric oxide. Patients with sickle cell disease (SCD) experience chronic intravascular hemolysis, and the vascular effects of chronic or intermittent exposure to free hemolglobin/heme may be responsible for many of the SCD complications pulmonary hypertension and vaso-occlusive crisis. Recent studies in some models suggest that free heme can also trigger activation of Toll-like receptors (TLRs) and downstream inflammatory signaling, suggesting that ongoing hemolysis can drive immune dysregulation. In this session, we will discuss recent developments in our understanding of how hemolysis affects pulmonary endothelial remodeling in SCD and the effects of acute and chronic transfusions on endothelial function. We will describe the molecular pathways that drive hemolysis-driven inflammation and potential therapeutic strategies that can reverse them. In addition, we will discuss the impact of hemolysis on the innate immune cells including monocytes and dendritic cells in patients with SCD and how this has implications for adaptive immune response to transfusions and alloimmunization. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 5 (9103-S) TTD I: Emerging Infectious Diseases and Other Blood Screening Issues Director/Moderator: Susan Stramer, PhD Speaker: Susan Stramer, PhD; Louis Katz, MD; Roger Dodd, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Provide background on emerging arboviral infections of concern to recipient safety. Provide an update to the status of Babesia microti interventions with emphasis on evolving policy. Can we/should we rethink current testing measures? Event Description: This session will provide an update regarding emerging infectious disease agents of diverse types, clinical presentations and geographic distributions for which an intervention is lacking or not required. For some agents, transfusion transmission may not yet be described or the agent's prevalence and associated disease burden is unknown or at a clinically tolerable level. The results of what is known about a select group of agents will be described as well as the results of studies investigating potential interventions. New FDA regulations provide a structure for testing for relevant transfusion transmissible infections (RTTIs). An overview of the regulation focusing on these RTTIs will be provided as well as thoughts on the question "Can we/should we rethink current testing measures?" (9104-TC) New Approaches to Treat Post Transplant and Surgical Thrombocytopenias Director/Moderator: Pampee Young, MD, PhD Speaker: Terry Gernsheimer, MD; Eric Gehrie, MD; David Kuter, MD, DPhil, FRCPath Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Review thrombopoiesis and receptors which regulate this process. Clinical findings in the use of thrombopoietin receptor agonists in immune thrombocytopenia (ITP). Recent progress and findings in application of TPO agonists in surgical thrombocytopenia. Event Description: Thrombopoietin (TPO) regulates thrombopoiesis through activation of TPO receptors on the megakaryocyte cell surface, resulting in increased platelet production. The TPO receptor agonists are novel treatments for patients with chronic ITP aimed at increasing platelet production through 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 6 interactions with the TPO receptor on megakaryocytes. Two TPO receptor agonists, romiplostim and eltrombopag, have received regulatory approval. More recently TPO receptor agonists have been used to treat surgical thrombocytopenia. We will discuss clinical data on the efficacy, safety, costeffectiveness, and impact on health-related quality of life of TPO receptor agonists in these applications. (9105-TC) Evaluating Antibodies for Clinical Significance, One Blood Group System at a Time Director/Moderator: E. Ann Steiner, MT(ASCP)SBB Check back for faculty and a detailed description. (9106-TC-HEM) Hemovigilance 101: How to Get Started and Why? Director/Moderator: Barbee Whitaker, PhD Speaker: Barbee Whitaker, PhD; Kathryn Haass, MPH, CPH, MT(AAB), BB(ASCP)M; Melanie Jorgenson, RN, BSN Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Increase awareness of hemovigilance and its use in the practice of transfusion medicine. Provide helpful instruction and tools for hospitals at various levels of hemovigilance. Describe how hemovigilance benchmarking data can be used to improve performance and utilization. Event Description: This session is designed to provide an introduction to hemovigilance. The history of hemovigilance, the important lessons learned, and the ongoing benefits of participation in hemovigilance programs will be discussed. Instructions for how to get started using hemovigilance definitions, how to enroll in the CDC NHSN Hemovigilance Module, how to participate with the AABB Center for Patient Safety will be explained. Lessons from a LEAN six sigma case study where the adverse event process from patient to blood center to reporting was streamlined will be highlighted. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 7 (9107-TC) Granulocyte Transfusion: Is it Effective? And is it Safe? Director/Moderator: Shiu-Ki Hui, MD Speaker: Fernando Martinez, M.D.; Brian Castillo, MD; Shiu-Ki Hui, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Describe the current published literatures on granulocyte transfusion in both adult and pediatric settings. Describe the component that is needed for an effective granulocyte transfusion. List the most common complications from granulocyte transfusion. Event Description: Granulocyte transfusion although has been around for decades, it's effectiveness continues to be a subject of debate. The RING trail has recently shred some much needed light to the subject of granulocytes. However, in regard to pediatrics its effectiveness remained unaddressed. There is also a lack of dedicated data on safety of granulocytes transfusion especially in regard to risk of CMV infection as the product cannot be leukoreduced. This session will present both published and local data on granulocytes transfusion in pediatrics in regard to both effectiveness and safety. In addition, this session will discuss the published data and local data on granulocytes transfusion in adults and how one large cancer focus hospital integrates these information into its current practice. (9108-QE) Moving Beyond Root Cause Error Analysis to Future Error Prevention Director/Moderator: Galen Kline, BS, CLSSBB Speaker: Matthew Audette; Beth Hughes, MT (ASCP); Galen Kline, BS, CLSSBB Intended Audience: Managers/Supervisors Teaching level: Intermediate Objectives: Discuss the concept of institutional learning and the benefits of designing work so that they are efficient and safe rather than spending more time dealing with the aftermath. Discuss real life instances in the Blood Center and Transfusion Service realm that led to reduced problems in the future from learned lessons in the past. Review tools that can be utilized to solve problems that haven't occurred yet. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 8 Event Description: The world continues to change and move at a rapid pace. With change comes more challenges to face from errors to inefficient process. Hours are spent trying to understand these issues and fix them after they happen. But what if we could do more to predict what will happen in the future and change the process beforehand. This session will discuss tools and practices blood centers and hospital based transfusion services use, such as process design and institutional learning and knowledge from past performance, to better align to a change and reduce the likelihood of failures. (9109-QE-PBM) Tools and Tricks for Your PBM Program Toolkit (PBM) Director: Nanci Fredrich, RN, BSN, MM Moderator: Melanie Jorgenson, RN, BSN Speaker: Renee LeBlanc, RN, BSN; Kimberly Waters, MSN, RN, CPHQ; Nanci Fredrich, RN, BSN, MM Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Enhance communication skills and creativity to create education materials related to PBM. Describe how everyday resources(Microsoft)can build data reports with meaningful metrics. Incorporate current research, case studies and available resources to augment a PBM program. Event Description: Patient Blood Management has become a focus at many institutions. Program coordination is often added to a current job or a TSO/PBMC is hired. What resources are available to use including case studies, interpreting research studies, or even applying for funding? How best to use and analyze the data you have to provide reports to others to show improvement? Development of new talents including communication using a variety of media types, data analysis and reports with meaningful metrics and current research and case studies is essential. Accessing resources to adapt to each PBM program is a key starting point for a successful PBM program. Learning new skills and networking with others in similar positions can lead to development of a toolkit filled with ideas and materials that can be adapted to the culture of an organization. This session will include open discussion about real-life situations and solutions as well as provide program coordinators, TSOs and PBMCs with additional tools, skills and tricks to build a resource toolkit. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 9 (9110-LMT) Operational Excellence: Coaching the Next Generation of Problem Solvers Director: Mark Malone, BS, ME Moderator: Ellen Ermer, MSE, CSSBB Speaker: Virginia Schoffelman, MSN, RN Intended Audience: Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Understand the improvement and coaching routine. Discuss your role as a coach, teaching staff how to use a scientific method for problem solving. Demonstrate how the improvement and coaching routine can create a culture of continuous improvement. Event Description: The improvement and coaching routine is a method that prepares staff to establish a daily habit in the use of scientific thinking for problem solving. It creates a paradigm shift in thinking about the role as a leader to a coach and the role of staff to daily problem solvers. It is how continuous improvement can be achieved and sustained. (9111-LMT) Risk-Based Decision-Making from Concept to Practice Director/Moderator: Judie Leach Bennett, LLM Speaker: Joanne Tossell, RN; George Kotsious; Padraig Williams, FACSLM, MSc.; Margaret Fearon, MD; Alyson Svenson Intended Audience: Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: To examine the experiences in translating this RBDM framework from theory into practice across multiple jurisdictions and cultures. To provide case studies based on in-practice examples that demonstrate the practical application of the RBDM framework. To discuss approaches for integrating the RBDM Framework with competing or complementary frameworks that impact on final decision making for blood operators. Event Description: This session will look at the practicality of risk-based decision making. The emphasis of the session will be translation from theory to practice. Focus will be on specific examples of use of the decision-making framework including the provision of actual case studies covering more difficult instances such as the implementation of a standardized tool across disparate cultures and working with regulators to integrate their framework. An example working through the online tool will also be demonstrated and the use of voting technology will maximize audience engagement in this powerful tool. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 10 12:00 p.m. - 2:00 p.m. (9112-S) NBF Grant Recipients' Lecture and Luncheon Director/Moderator: Jeanne Hendrickson, MD Speaker: Anand Padmanabhan, MD, PhD, MA; Jeffrey Carson, MD; Mobin Karimi, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Intermediate to Advanced Objectives: Discover how the NBF Scientific Research Grants Program has advanced original research for early-career investigators in the areas of blood banking, transfusion medicine, cellular therapies and patient blood management. Assess and appreciate how NBF-funded exploratory research activities have driven developments that improve patient and donor care. Explore cutting-edge discoveries that will shape transfusion medicine, cellular therapies and patient blood management in the future. Event Description: This lecture showcases the research activities of three earlycareer transfusion medicine and cellular therapies investigators who are utilizing or have utilized NBF grant funding to develop their investigations into highly productive transfusion medicine, cellular therapies or patient blood management research programs. The NBF Award for Innovative Research (formerly the David B. Pall Prize for Innovative Research and the Jack Latham Memorial Award for Innovative Research) will be awarded at this luncheon to a previous NBF grant recipient who has developed his/her studies into high-profile innovative research with substantial impact that may ultimately lead to improving patient outcomes. This year the award is supported by Blood Systems, Inc. Enjoy a delicious lunch while the scientists discuss their latest research with a focus on the role their findings will play in driving the future of transfusion medicine, cellular therapies and patient blood management. Time for questions and informal discussion will be provided. This luncheon is complimentary to all attendees registered for the full meeting on Saturday, Oct. 22 only. A ticket is required to attend and seating is limited. Please check the appropriate box during your Annual Meeting registration process. (9113-TC) Apheresis Luncheon: Expert Guidance on Dealing with Challenging Apheresis Procedures Director: Joseph Schwartz, MD, MPH Moderator: Tina Ipe, MD, MPH Speaker: Meghan Delaney, DO, MPH; Huy Pham, MD, MPH; Lance A. Williams, MD 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 11 Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Outline how to approach an apheresis consult. Review examples of challenge issues in pediatric apheresis management. Discuss the challenges and urgency of red blood cell exchange procedures. Event Description: Therapeutic apheresis is used to treat many disorders. The American Society for Apheresis (ASFA) publishes evidence-based guidelines every 3 years to assist apheresis practitioners in the rationale, technical, and management of apheresis patients. Nonetheless, the guidelines provide limited guidance on the timing of the procedure. For example, category I indications do not always require urgent treatment. In this session, a summary of the ASFA guidelines and a review of how to perform an apheresis consult will be provided. Furthermore, case studies of different emergent apheresis indications will be used to outline the approach as well, as the technical challenges in the management of emergent or technically challenging patients. Specifically, fluid balance considerations in emergent adult and pediatric apheresis procedures as well as indication and urgency for red blood cell exchange will be discussed. 2:00 p.m. - 3:30 p.m. (9114-S-CT) Immune Tolerance: Combined Cellular and Organ Transplantation Director/Moderator: Thomas Spitzer, MD Speaker: Joseph Kiss, MD; Thomas Spitzer, MD; Tatsuo Kawai Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: To understand the principle of immune tolerance and how it is being applied clinically. To understand the biologic basis of tolerance induction. To appreciate the range of clinical applications for tolerance protocols. Event Description: Immune tolerance, with avoidance of the need for systemic immunosuppression after organ transplants has long been considered the "Holy Grail" of transplantation. This event will explore the biologic basis of and clinical applications for tolerance induction strategies with a focus on tolerance through hematopoietic chimerism. The three lectures will describe pre-clinical models of tolerance induction that led to tolerance protocols and the combined bone marrow and organ (kidney) and composite tissue transplants that have been performed in patients with and without an underlying malignancy. Possible 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 12 mechanisms of tolerance induction, both central and peripheral, that has been achieved in those patients will be described. Future tolerance induction strategies may include other organ or tissue transplants and delayed bone marrow transplant approaches. (9115-S) Don't We Know it All Yet? What's New in Hemostasis? Director/Moderator: Maureane Hoffman, MD, PhD Speaker: Alisa Wolberg, PhD, FAHA; Robert Flaumenhaft, MD, PhD; Maureane Hoffman, MD, PhD Intended Audience: Physicians, Scientists Teaching level: Intermediate to Advanced Objectives: Become aware of the different states of platelet activation and the role they may play in hemostasis and thrombosis. Appreciate the role of coagulation factor XIII and RBC in the structure and stability of hemostatic and thrombotic blood clots. Appreciate the emerging information on the role of thiol isomerases in hemostasis and thrombosis. Event Description: This program will cover selected topics where recent data is changing our concepts of how hemostasis is regulated. Dr. Maureane Hoffman will review recent work on the different states to which platelets can be activated, leading tp expression of different levels of hemostatic activity. This work has led to a better understanding of how platelet responses are "fine tuned". Dr. Alisa Wolberg will review the recent work of her lab and others on the role fibrinogen and FXIII function in thrombus formation and structure, and role that RBC retention plays in clot stability. Dr. Robert Flaumenhaft will present his work on the procoagulant activity of protein disulphide isomerase (PDI), its role in thrombosis and the therapeutic potential of PDI inhibitors. (9116-S) Hot Topic: Zika and Its Impact to Transfusion (SAM) Director/Moderator: Susan Stramer, PhD Speaker: Lisa Pate, MD, JD; Lyle Petersen, MD, MPH; Luiz Amorim, MD; Jeff Linnen, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: To review the virology, epidemiology, clinical significance and public health implications of Zika virus. To describe the impact of Zika virus in Brazil. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 13 To describe the testing strategies that have been introduced in the US and a summary of their findings to date. Event Description: With the introduction of Zika virus into the Americas, associated explosive outbreaks in Brazil and other countries worldwide since 2013, demonstration of Zika virus RNA in blood donors, documented transfusion transmission, linkage to microcephaly, Guillain—Barré and other nervous system disorders, strategies are needed to protect the safety of the blood supply from this primarily mosquito-borne flavivirus. This session will describe background information on the characteristics of the virus, its epidmiology, clinical outcomes associated with viral infection and public health considerations followed by a description of the outbreak in Brazil and lastly interventions that have been introduced in the United States using investigational NAT assays including experience to date. A question and answer session will follow the formal presentations. (9119-TC) Implementing Pathogen-Reduced Apheresis Platelets Director/Moderator: Bill Flegel, MD Speaker: Sherry Sheldon, MT(ASCP)SBB; Dayand Borge, MD, PhD; Jean-Pierre Allain, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Describe actual implementation examples at blood centers and hospitals. Review regulatory/quality assurance requirements and the education of clinical staff before introducing pathogen-reduced platelets. Evaluate a technology of pathogen-reduction beyond platelets & plasma. Event Description: Pathogen-reduction technologies for platelet and plasma components are approved for clinical use in the US since 2014. The implementation of the new technologies may raise questions and pose challenges. Knowledge and careful planning of the regulatory and quality assurance aspects will facilitate the process of introducing pathogen-reduction at blood centers. Early involvement and educating the clinical users during the implementation process is critical. There will be plenty of opportunity for audience participation and questions. (9121-TC) Transfusion Related Circulatory Overload: What's New? Director: Jay Raval, MD Moderator: Aaron Tobian, MD, PhD Speaker: Jay Raval, MD; Chester Andrzejewski, PhD, MD; Ian Welsby, MB BS 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 14 Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Describe the pathophysiology, incidence with different blood components, and patient risk factors associated with Transfusion Associated Circulatory Overload (TACO). Recognize how utilization of informatics and the electronic medical record system can positively impact the occurrence of TACO. Explain what diagnostic and therapeutic interventions/strategies (and the strength of associated evidence for these interventions/strategies) are available to decrease/prevent TACO reactions. Event Description: Transfusion Associated Circulatory Overload (TACO) is a frequently underreported complication of transfusion that is currently the second most common cause of transfusion-related fatalities. In this session, TACO's pathophysiology, patient's at high-risk of developing TACO, and its incidence of occurrence with different blood components will be covered. Use of informatics technology and the electronic medical record as tools to combat the occurrence of TACO in real time will be discussed. Lastly, the different diagnostic and therapeutic interventions/strategies to treat/prevent TACO and associated evidence will be explored. (9122-QE) Practical Aspects of Big Data in Patient Blood Management Director/Moderator: Mark Ereth, MD Speaker: Steven Frank, MD; Jamison Feramisco, MD Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Understand the necessity of actionable analytics in PBM. Understand the integration of Big Data into PBM programs. Appreciate the derivation of hyper-personalized transfusion practices via Big Data. Event Description: Didactic presentations with speaker moderation and attendee interaction. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 15 (9123-QE) CAP Proficiency Testing: Review of Test Performance & Future Directions Director: Karen King, MD Moderator: Yara Park, MD Speaker: Alexandra Valsamakis, MD, PhD; Evelyn Lockhart, MD; Nicole Zantek, MD, PhD Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: To understand the regulations that require PT testing, which tests are graded and ungraded, and the implications of the regulations. To learn from the collective experience of PT surveys that show issues with test performance To gain exposure to the newest offerings from CAP for transfusion service and blood supplier laboratories. Event Description: In this session, members of the College of American Pathologists (CAP) Transfusion Medicine Resource Committee will review the current state of proficiency testing regulations and objectives. Issues with specific PT surveys will be discussed, including fetal bleed detection, and infectious disease testing. New offerings for PT will be highlighted to show the advancement of transfusion service laboratory capabilities. 2:00 p.m. - 5:30 p.m. (9117-TC) Sally Frank Memorial Award and Lectureship Director: Patricia Whitacre, MT(ASCP)SBB Award Description: The Sally Frank Memorial Award and Lectureship was established in 1982 in memory of Ms. Sally Frank and her dedication to red cell serology and education. This award recognizes an individual who is, or has been, a medical technologist involved with these fields and has demonstrated quality research, teaching and/or service abilities in the technical aspects of immunohematology. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 16 (9118-TC-HEM) Aspectos Practicos e Innovadores de la Hemovigilancia GCAMTAABB Director: Nancy Benitez, MHS (ASCP) SBB Moderator: Graciela Leon, Hematologist, MD Speaker: Graciela Leon, Hematologist, MD; Eduardo Muniz Diaz, Director Medico, Hematologo; Cesar Cerdas-Quesada, Director Medico- Hematologo Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Demostrar los beneficios de la Hemovigilancia en la seguridad de donantes de sangre, productos sanguneos y pacientes. Revisar el propsito de los estndares y guas Internacionales, asi como los requisitos de calidad para la implementacin de un programa de Hemovigilancia. Revisar y discutir casos prcticos para ejemplificar el programa de Hemovigilancia. Event Description: En este taller expertos en sistemas de Hemovigilancia revisaran como la implementación de este programa aumenta la seguridad de los pacientes, donantes de sangre y productos sanguíneos. Se revisara el uso de técnicas de análisis y monitoreo del proceso. Los Estándares, historia y guías de calidad serán revisados y aplicados a casos prácticos interactivos (9120-TC) Thrombotic Microangiopathies: Current Treatments and Future Directions Director/Moderator: Kenneth Friedman, MD Speaker: Kenneth Friedman, MD; Marisa Marques, MD; X Long Zheng, MD, PhD; Bradley Dixon, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate Objectives: Be able to select an appropriate clinical and laboratory evaluation of a patient presenting with symptoms suggestive of thrombotic microangiopathy. Understand the current recommended therapy for a patient with thrombotic thrombocytopenic purpura and be aware of emerging therapies. Be able to triage patients presenting with signs consistent with a diagnosis of atypical hemolytic uremic syndrome and understand treatment alternatives. Event Description: Advances in the understanding of the pathogenesis of thrombotic microangiopathies have improved our ability to distinguish thrombotic 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 17 thrombocytopenic purpura (TTP) from atypical hemolytic uremic syndrome (aHUS). Delineation of the role of ADAMTS13 in the pathogenesis of TTP affords improved diagnosis and the potential for new therapeutic options. aHUS remains a clinical diagnosis, but improved understanding of the role of complement has resulted in replacement of plasma exchange therapy by targeted drug treatment for appropriately selected patients. During this session, clinical and laboratory evaluation of these thrombotic microangiopathies will be reviewed as well as current therapies and emerging therapeutic options. (9124-LMT) Armed Services Blood Program Director: Roland Fahie, Medical Service Corps, USN Moderator: Air Force Lieutenant Colonel Jerome Vinluan, Deputy Director Operations, Armed Services Blood Program Speaker: Roland Fahie, Medical Service Corps, USN Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate Objectives: Identify the operations and reach of the military blood program through innovation research and development, humanitarian assistance, and theater blood support. Identify strategic business objectives driving major developments in the Armed Services Blood Program. Report on military blood program medical support efforts regarding overseas contingency operations. Event Description: This session will provide the audience and members with dynamic insight into the strategic business objectives that drive military blood program operations around the world. United States Armed Services Blood Program leaders, including our Joint Blood Program Officers from our Combatant Commands will showcase recent and ongoing wartime and humanitarian blood program support. In addition, a discussion on research and development designed to bring blood and blood products closer than ever to the point of injury, will be presented by those individuals most closely involved in this critical mission. The session will close with the Lifetime Achievement Award ceremony, which honors awardees for lifelong, transformative contributions to the Armed Services Blood Program. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 18 (9125-LMT) Change Readiness: One Way or Another Director/Moderator: Peggy McAleer, BS, CQA(ASQ) Speaker: Dan Waxman, MD; Morris Connie, MM, MT(ASCP)BB,HP Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Explore ways management can facilitate change readiness. Describe methods to help empower employees to gain productivity and efficiency. Create an environment for cooperation rather than contention. Event Description: In every aspect of business, change seems to be the only constant for employees in the age of reorganization, redeployment and restructure. With the vast changes and uncertainty hanging over the healthcare industry now, more than ever, blood banks must be lean, mean, changing machines. Change will happen, one way or another. Successful, timely change readiness requires skilled direction and cooperation from all levels of the organization. Empowered employees can bring about improvements in quality and productivity while improving morale. Experienced leaders in the industry will discuss both the challenges of the current environment as well as effective methods they utilize to drive successful changes. 4:00 p.m. - 5:30 p.m. (9126-TC-CT) Cellular Therapy for Neurological Diseases Director/Moderator: Michele Sugrue, MS, MT(ASCP)SBB Speaker: Duane Mitchell, M.D., Ph.D.; Joanne Kurtzberg, M.D. Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate Objectives: Review historical background and laboratory approaches for cellular therapy in neurological diseases. Discuss the current status of cellular therapy and associated clinical trials neurological diseases. Describe innovative applications of immunotherapy to treat malignant brain tumors. Event Description: Recent advances in cellular therapy have been found to be promising therapeutic options for the treatment of numerous neurologic diseases. Pre-clinical cellular therapy studies in neurodegenerative disorders such as Parkinson's disease, Huntington's disease, and amyotrophic lateral sclerosis as 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 19 well as neurovascular impairment conditions (i.e., stroke) have had encouraging results and are quickly moving into clinical trials. In addition, harnessing the potential of cellular immunotherapy, studies have demonstrated that one may drive the immune system to attack neuro-derived brain cancer cells. In this program, speakers will review the strategies and methodologies for these innovative approaches. The status of translational investigations and current clinical trials will be discussed. In addition, future modalities and approaches to developing curative therapies will be addressed. (9127-QE) You did WHAT?!? Error Management: Transforming Lemons into Limoncello Director/Moderator: Theresa Downs, MT(ASCP)SBB, CQA(ASQ) Speaker: Sheri Goertzen, MT(ASCP)BB, CLS(CA), CQA(ASQ); Maureen Beaton, MT(ASCP)BB, CQA(ASQ) Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Intermediate Objectives: Discuss the importance of error management to transfusion service operations. Examine two error management systems to track and trend variances. Describe ways to find and analyze mistakes/errors to improve processes and operations. Event Description: You have a choice...you can view an error either as an irritation or an opportunity. This session will discuss the identification and management of errors in a transfusion service. Learn why error management is critical to quality operations, how to value these learning opportunities and make the most of them. Examples of various tools used to capture, track and manage errors will be shared. (9128-QE-CT) cGMP Laboratory Basics Director/Moderator: Yvette Tanhehco, PhD, MD, MS Speaker: Adrian Gee, PhD; Don Siegel, MD, PhD; Yvette Tanhehco, PhD, MD, MS Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Discuss the design, operation, and regulatory requirements of a cGMP laboratory and differentiate it from a GTP laboratory. Discuss the utility of a cGMP laboratory. Discuss the challenges and lessons learned from opening a cGMP laboratory. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 20 Event Description: The US Food and Drug Administration (FDA) regulates the quality of biologics and pharmaceuticals very carefully. The main regulatory standard for ensuring a high quality product is the Current Good Manufacturing Practice (cGMP) regulation for human pharmaceuticals. cGMP regulations provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality and purity of products. Transfusion medicine physicians are frequently involved in the manufacture of biologics so knowledge of the design, operation and validation of a cGMP laboratory is paramount. This session will discuss the basic aspects of running a cGMP laboratory. (9129-QE) Validation 101 Director/Moderator: Regina Castor, BS, MT(ASCP)SBB Speaker: Rosemary Steuber, MT, SBB(ASCP) Intended Audience: Scientists, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Describe the purpose of validation as it relates to transfusion services. Define regulatory requirements for validation (including Installation, Operational Qualification, and Performance Qualification). Explain the process of validation and describe common pitfalls to avoid. Event Description: This session will introduce validation to those who are new to writing and/or executing validation in the transfusion world. It will review regulatory requirements, present scenarios, and describe some pitfalls to avoid in the validation process. Primary emphasis will be on instrumentation but content will also apply to other equipment and processes. (9130-LMT) Balancing Technical and Administrative Functionality: The Making of the Next Generation of Laboratory Leaders Director: Steven Armstong Moderator: Karafa Badjie, MS, MLS(ASCP)SBB, BMLSc Speaker: Ricardo Sumugod, MS, MT(ASCP)SBB; Steven Armstrong, MSHA, MT(AMT), SBB(ASCP), FACHE; Karafa Badjie, MS, MLS(ASCP)SBB, BMLSc Intended Audience: Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Provide tools and examples on how to balance technical and leadership development. Provide ideas on how to successfully handle the rapid rate of change in healthcare today. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 21 Provide basic financial management tools used for providing fiscally sound laboratory leadership. Event Description: In the modern day laboratory, leadership development must be seen as much as a priority as technical skill enhancement. Balancing the technical knowledge to be a great laboratorian, while also providing individuals with the business and leadership skills needed to be successful supervisors and managers, is a challenge in the constantly changing healthcare environment. This session will provide ideas and examples on how to successfully engage and develop new staff members both technically and as leaders for succession planning. Technical and staff development, change management techniques, and fiscal accounting tools will be discussed while providing examples on their use from the leadership perspective. (010A) Scientific Oral Abstract Session: Cellular Therapies and Immunotherapies (010B) Scientific Oral Abstract Session: Donor Recruitment, Retention and Adverse Events (010C) Scientific Oral Abstract Session: Transfusion-Transmitted Infectious Diseases: Zika Virus 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 22 SUNDAY, OCTOBER 23, 2016 8:30 a.m. - 9:15 a.m. (9201-S) Emily Cooley Memorial Award and Lectureship: From Cytokines to Pragmatic Designs: Changing Paradigms Director/Moderator: Jose Cancelas, MD, PhD Speaker: Nancy Heddle, MSc, FCSMLS(D) Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate Objectives: To understand how twelve patients informed the pathophysiology of febrile non hemolytic transfusion reactions. To explore the stored blood controversy and the role of big data and pragmatic research designs to determine whether stored blood affects patient outcomes. To identify important lessons learned from over 25 years of involvement in clinical research. Award Description: This award began as a lectureship in 1963 and was designated as a Memorial Award in 1983. The person who receives this award shall have demonstrated teaching ability and have made a major contribution to the field of transfusion medicine or cellular therapies. 8:30 a.m. - 10:00 a.m. (9206-QE-CT) Nonconforming Cellular Therapy (CT) Products- What Do We Do Now? Director/Moderator: Lisa Phillips Johnson, MT(ASCP)SBB, CQA, CMQ/OE, RAC Speaker: Hanh Khuu, MD; Lisa Phillips Johnson, MT(ASCP)SBB, CQA, CMQ/OE, RAC Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Describe what nonconforming products, services or materials are in CT setting. Provide an overview of the regulatory and quality system requirements from FDA and accrediting agencies for 351 and 361 products. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 23 Using real-life scenarios, show how problems encountered during manufacturing can be addressed and demonstrate how process improvements resulted from these lessons. Event Description: During the manufacturing process of cellular therapy products, from collection and cryopreservation to natural killer cell products, things may go awry. This session will outline the regulatory and quality system requirements in 351 and 361 product settings and operational systems needed to support the management of nonconforming products, services and materials. Several real-life scenarios will be discussed to describe what went wrong and how to address these problems in real time, as well as demonstrate how these headaches can be opportunities for process improvement, overall. (9207-LMT ARS) Operational Excellence Practitioner Program: Building Your Leadership's Bench Strength in Continuous Improvement Director: Mark Malone, BS, ME Moderator: Joanne Voordeckers, ASQ CSSBB Speaker: Sherri Cyrus, MT(ASCP)SBB ; Joanne Voordeckers Intended Audience: Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate to Advanced Objectives: Learn how to accelerate your Operational Excellence journey with the addition of part-time OE Practitioners. Learn about a program that will help you to develop your leadership bench strength in continuous improvement methodologies. Hear a real-life case study of the challenges and successes of the OE Practitioner role. Event Description: Leaders are selected to work part-time in a role called OE Practitioner for a period of 2 years. They attend special training to learn continuous improvement tools and understand the culture change necessary to sustain gains made by the OE initiative. So as not to over-burden any one individual, the time the Practitioner spends on OE is back-filled by employees who desire to grow into their next positions. As teams become engaged in the daily problem-solving improvement routines and huddles associated with Operational Excellence, it helps them to know they have a knowledgeable "boots on the ground" leader in the OE Practitioner to assist them in practicing their new-found skills. This is particularly true in environments with multiple facilities and the seemingly universal issue of limited resources. These leaders are getting something out of it, too, besides more work. They will have developed a deeper understanding of OE principles so that as they work in their full-time role, they are in a better position to foster and sustain the culture change. As years go by, 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 24 the number of these leaders will grow and be key to changing the culture of the organization. 8:30 a.m. - 12:00 p.m. (9203-TC-RC ARS) AABB Donor History Questionnaire Director/Moderator: Sheila O'Brien, PhD, RN Speaker: Sheila O'Brien, PhD, RN; Mary Townsend, MD; Yvette Miller, MD; Sheila O'Brien, PhD, RN Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: To present highlights of the revised AABB Donor History Questionnaire and accompanying materials including changes to comply with the final rule. To explore the social, emotional and practical issues of determining the gender of donors who do not self-identify as their birth gender. Gender identification is necessary for gender specific DHQ questions. To explain the rationale for donor deferral for various medications identified using the DHQ and Medication Deferral List, and discuss practical approaches to balancing the ever-increasing number of new drugs on the market while keeping the process simple enough for donors to provide complete and accurate histories. Event Description: In 2016 a full revision of the AABB Donor History Questionnaire (DHQ) and accompanying materials was completed (Version 2.0), and is compliant with the May 2015 Final Rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,” and the December 2015 FDA Guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” In this session the AABB Donor History Task Force will present highlights of the revised DHQ and accompanying materials. Key transgender issues will be identified and approaches in different jurisdictions will be discussed to assist facilities as they develop their own policies to address application of the gender-specific questions. The rationale behind the inclusion of various medications for deferral will be explained and the new approach in the AABB DHQ and Medication List will be presented. (9205-QE) SBB/BB Exam Review Director/Moderator: Jayanna Slayten, MS, MT(ASCP)SBBcm 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 25 Speaker: Jayanna Slayten, MS, MT(ASCP)SBBcm; LeeAnn Walker, MEd, MT(ASCP)SBB; Lorraine Blagg, MA, MLS(ASCP)SBB; Stacey Alvey, MEd, MT(ASCP)SBB; Kate Hernandez, MT(ASCP)SBB Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Review SBB and BB exam requirements and the content outlines for each exam. Provide references for each content area. Highlight pertinent information that may be covered on these exams. Discuss helpful hints for studying for and taking these exams. Event Description: It would be impossible to present all the information needed to pass the SBB or BB exams in a three-hour program. This program will provide a roadmap for those preparing for the BB or SBB exam. Content areas of the exams will be highlighted with emphasis on where to find information required for successful completion of these exams. A study guide with references for each section will be provided to attendees of this session. (9204-TC ARS) Chief Technologist SIG Director: Gary Pawlak, MT(ASCP) Moderator: Terri Hintz, MT(ASCP)SBB, CQA(ASQ) Speaker: Suzanne Butch, MA, MLS(ASCP)SBB, CM; Diane Schafer, MSA, MT(ASCP)SBB; Melanie Champion, CQA(ASQ), MBA, MT(ASCP)SBB; Theresa Downs, MT(ASCP)SBB, CQA(ASQ); Doris Ratcliff, MSHCM, MT(ASCP)SBB; Christine Terranova, BS, MT(ASCP) Intended Audience: Technologists, Managers/Supervisors Teaching level: Intermediate Objectives: Discuss the strategies of RHD genotyping for pregnant women and other females of child bearing age who exhibit a Serologic Weak D phenotype or discrepant Rh typing. Discuss implementation strategies and hurdles of maintaining a 7-day platelet inventory. Identify the challenges of implementing and testing a Disaster Plan for the Blood Bank. Event Description: This session presents and discusses topics related to transfusion services. Short presentations and panel discussions with audience participation make up the first half of the session. The second half is devoted to discussion of questions posed to the audience using an audience response system. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 26 9:15 a.m. - 10:00 a.m. (9202-S) Tibor Greenwalt Memorial Award and Lectureship Director/Moderator: Jose Cancelas, MD, PhD Speaker: Parviz Lalezari, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate Objectives: Learn the historical developments that made possible the identification and characterization of neutrophil antigens and their role in common forms of antibody-mediated neonatal neutropenia. Award Description: This award honors Tibor Greenwalt, MD, who was the first registrant at the first AABB Annual Meeting and founding editor of TRANSFUSION. The award recognizes an individual who made major scientific or clinical contributions to hematology, transfusion medicine or cellular therapies and succinctly communicated these advances. The title of Dr. Lalezari’s presentation is: Immunology of NeutrophilSpecific antigens. 10:30 a.m. - 12:00 p.m. (9208-S) TTD II: Pathogen-Reduction Technology — Impact on Blood Operations and Future Developments Director/Moderator: Steve Kleinman, MD Speaker: Heather Pidcoke, MD, PhD; Harvey Klein, MD; Richard Benjamin, MD; James AuBuchon, MD, FCAP, FRCP(Edin) Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Review the general issues related to decisions to implement pathogen reduction technology Review the use of PRT and other potential alternatives to decrease the risk of bacterial contamination from platelet transfusion Review status of R&D clinical trials for red cell and whole blood pathogen reduction. Event Description: Pathogen reduction technologies have the potential to radically alter our approach to providing safe transfusion. Their practical application to create pathogenreduced blood components raises a variety of questions and poses considerable challenges. The value of directly diminishing or even eliminating the residual risk of bacterial contamination as well as that of current and future viral and other pathogens' threats while potentially eliminating some redundant tests are important goals. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 27 This workshop will provide a general overview of issues related to PRT and update studies on bringing red cell/whole blood pathogen reduction technologies to commercial use. (9209-S-CT) Gene Therapy is Back Director/Moderator: Jose Cancelas, MD, PhD Speaker: Brian Sorrentino, MD; Punam Malik, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Learn how current gene therapy protocols are being implemented in clinical trials for therapy in congenital immunodeficiencies and hemoglobinopathies. Event Description: First-hand experience of leaders in the field of gene therapies. The session will update the audience on the current status of gene therapies in immunodeficiencies and hemoglobinopathies and what are the current challenges (biological, technical and regulatory) for the extension of these trials to large cohorts of patients. (9210-S) Mechanisms of Antibody-Mediated Hemostatic Diseases Director/Moderator: Kenneth Friedman, MD Speaker: Jacob Rand, MD; Anand Padmanabhan, MD, PhD, MA Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: To understand currently proposed pathogenic mechanisms in two immune-mediated thrombophilic conditions, antiphospholipid syndrome and heparin-induced thrombocytopenia. Be able to propose a diagnostic evaluation of a patient who might have antiphospholipid syndrome and discuss the limitations of current assays. Be able to select currently available lab studies to evaluate a patient for heparin-induced thrombocytopenia and anticipate advances in the diagnosis of that condition. Event Description: Immune mediated thrombophilic conditions such as antiphospholipid syndrome (APS) and heparin-induced thrombocytopenia (HIT) are characterized by the presence of pathologic autoantibodies in patient blood. The clinical manifestations of APS include vascular thrombosis and pregnancy complications. Autoantibodies that recognize phospholipid-binding proteins are implicated in this disease, but the exact mechanism by which these antibodies trigger thrombosis remains unclear. Autoantibodies to heparin-PF4 complex 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 28 activate platelets, monocytes and endothelium in HIT, however the mechanisms that trigger the immune response are still being elucidated and recent technical improvements may allow enhanced diagnostic accuracy. In this session we will learn of recent findings related to mechanism of disease and implications related to diagnosis and management of these two thrombotic immunologic conditions. (9211-TC-HEM ARS) Stump the Hemovigilance Experts Director/Moderator: Barbee Whitaker, PhD Speaker: John Roback, MD, PhD; Pierre Robillard, MD; Kamille West, MD Intended Audience: Physicians, Scientists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Identify adverse reactions by their case definitions. Participate in coding challenging case reports using the national definitions. Discuss imputability and learn about the relationship between transfusions and reactions. Event Description: Come for a return engagement of the Hemovigilance Experts! This event provides the opportunity to participate in the analysis and coding of transfusion reactions using the definitions adopted by the CDC National Healthcare Safety Network - Hemovigilance Module. Bring or submit cases from your experience (complex or simple) and discuss categorization with the experts. (9212-TC ARS) Perspectives on Massive Transfusions: Surgeons, Blood Centers and the Impact on the Community Director/Moderator: Claudia Cohn, MD, PhD Speaker: Jed Gorlin, M.D., M.B.A.; James Harmon, MD; Jeffrey Kahn, PhD, MPH Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Basic to Intermediate Objectives: A bedside view of massive transfusions: Do surgeons and intensivists need help from the blood bank? A view of massive transfusions from the donor center: Can a single massive transfusion threaten the blood supply for other hospitals in the region? An ethics perspective on massive transfusions: The challenge of balancing the needs of individual patients and maintaining an available resource for the community. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 29 Event Description: This section will explore massive transfusion protocols from three perspectives: a surgeon trying to save a bleeding patient; a medical director of a blood center, who is trying to balance the demands from multiple hospitals while a single MTP drains the inventory; and finally an ethicist, who will explore the allocation of scarce resources in medicine. This section will ask who is responsible for ending an MTP when the effort to keep one patient alive exceeds normal limits. We will also look at the larger role of the blood bank during MTPs. (9213-TC ARS) An Evidence Based/Consensus Guideline from the International Collaboration for Transfusion Medicine Guidelines (ICTMG): Management Strategies of Fetal and Neonatal Alloimmune Thrombocytopenia Director: Lani Lieberman, MD Moderator: Michael Murphy, MD, FRCP, FRCPATH, FFPATH (M.) Speaker: James Bussel, MD; Dick Oepkes; Lani Lieberman, MD; Taman Bakhoul; Jens Kjeldsen-Kragh, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Review antenatal treatment options for women with a past history of a FNAIT pregnancy including steroids and intravenous immunoglobulin and intrauterine transfusion. Review the treatment options for neonates diagnosed with FNAIT. Present results of the systematic review related to the use of HPA alloantibody titres to assess the presence and severity of FNAIT. Event Description: Controversies regarding the optimal antenatal management, postnatal treatment and predictors of severity of fetal and neonatal alloimmune thrombocytopenia persist. Practice varies internationally and often depends on expert consensus. The International Collaborative in Transfusion Medicine will present results of their systematic reviews, and discuss recommendations regarding treatment strategies. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 30 (9214-TC-CT) How to Handle the Surge in Clinical Trials in the Cellular Therapy Laboratory Director/Moderator: Lizette Caballero, MLS (ASCP)CM Speaker: Lizette Caballero, MLS (ASCP)CM; Ronit Slotky, PhD, MSc; Jolynn Procter, MEd, BS, MT&SBB(ASCP), CQA (ASQ) Intended Audience: Physicians, Scientists, Technologists Teaching level: Basic to Intermediate Objectives: Discuss the challenges of addressing discrepancies between provider's procedure and in-house procedure, combing existing labelling system with outside provider's requirements, and employee training. Review the regulatory challenges. Discuss the need to ensure that FDA and local government licensure covers the type of cells used in the investigational protocol, and examine the challenge of ensuring HIPPA compliance while sharing patients' private information with outside providers. Review assessment of investigational studies costs and re-imbursement. Event Description: This session will discuss the complexity of incorporating multiple clinical trials, such as corporate or multicenter sponsored, into the routine cellular therapy laboratory environment. It will provide an overview of the logistical, regulatory, and resources aspects. The discussion will review the process from initial protocol review, site initiation visit, employee training, labelling and documentation, to budgetary challenges. (9215-QE) Effective Communication Between the Collection Facility, the Cell Manufacturing Laboratory, the Transfusion Service and the Clinician Director/Moderator: J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB Speaker: Michael Linenberger, MD; Karen King, MD; Kamille West, MD; David Stroncek, MD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Describe compliant and efficient ways to handle unusual situations that may arise in screening, procurement, manufacturing or administration of cellular therapy products. Identify internal system resources that may be consulted to help navigate unusual circumstances in Cellular Therapies. List effective communication strategies to bridge different disciplines that must work together to ensure quality outcomes when using Cellular Therapy Products. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 31 Event Description: The session will use a case study format to present unusual circumstances in one or more areas of Cellular Therapy. A panel of representatives including areas of donor eligibility determination, procurement, manufacturing, and clinical use as well as representative for transfusion support will discuss the aspects of the cases. The moderator and panel encourage audience participation for engaged learning. (9216-LMT-CT) Hemphill-Jordan Leadership Award and Lectureship Director: Mary Lieb, BS, MT(ASCP)SBB, CQA(ASQ) Award Description: This award honors leaders from the transfusion medicine and cellular therapy community. The award recognizes an individual who has made significant contributions in the areas of administration, quality programs, law and/or government affairs. The individual has demonstrated leadership qualities and a consistent willingness to lend his/her expertise to his/her peers. The award may recognize one particular act or an accumulation of contributions throughout many years. 12:00 p.m. - 2:00 p.m. (9238-S-CT) Cellular Therapies Sizzling Topics Luncheon: New Frontiers in Cellular Therapy Director: David Stroncek, MD Speakers: Julia Goldstein, MD; Elina Linetesky, PhD; Kelley Capocelli, MD; Andrew Fesnak, MD Intended Audience: Teaching level: Event Description: Cellular therapies are reaching new frontiers. The range of cells utilized and methods of collection and manufacture are critical to optimizing function in clinical applications. Regulatory demands also guide how therapies should be developed. This session will address optimizing collection of MNCs, an important source of therapeutic cells, from both adults and children for cancer treatment. In addition, the manufacture of pancreatic cells being pursued as a means to restore physiological beta cell function in patients with diabetes will be presented in the context of regulatory strategies and outcomes. Presentations of the latest information ─ with attendee participation─ should make this luncheon sizzle! 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 32 2:00 p.m. - 3:30 p.m. (9217-S-CT) Clonal Analysis of Hematopoiesis Director/Moderator: Jose Cancelas, MD, PhD Speaker: H. Leighton Grimes, PhD; Claus Nerlov, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Advanced Objectives: Learn how single-cell transcriptome analysis has revolutionized our understanding of the hierarchical organization of the stem cell and progenitor populations that make mature blood cells. Event Description: The final goal is to understand the molecular basis for and spatial organization of hematopoiesis, and to use this knowledge to devise cell based and molecular therapies that can be used to treat hematopoietic insufficiencies and malignancies. This session will provide an update on how single-cell genetic information is helping us understand the complex nature of blood formation and hierarchical organization. (9218-S) Who Are Alloantibody Responders and What Can We Do For Them? Examining the Evidence from Human Studies & Animal Models and Discussing Solutions to Mitigate RBC Alloimmunization in 'Responder' Patients Director/Moderator: Christopher Tormey, MD Speaker: Christopher Tormey, MD; Sean Stowell, MD,PhD; Stella Chou, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Familiarize participants with concept of alloantibody 'responders' in transfusion practice, including the formulation of a working definition for the 'responder' patient and identifying clinical & biological influences which may contribute to the responder state. Introduce advancements made via animal model research that have enhanced our understanding of what governs the response to RBC transfusions, including factors which impact the alloimmunogenicity of transfused RBCs and how tolerance to blood group antigens may be achieved. Discuss alloimmunization mitigation strategies applicable to responder patients, in particular the strengths/weaknesses of traditional options (e.g., blood group antigen phenotyping) and the exciting possibilities offered by emerging technologies (e.g., genotypic antigen matching). 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 33 Event Description: Alloimmunization to RBC antigens remains a criticallyimportant issue. However, not all patients who are exposed to foreign RBCs become alloimmunized. Based on observational studies, the concept that only a distinct subset of individuals ('responders') may be capable of mounting an immune response to RBC antigens has emerged. A better understanding of what defines a responder and how they can be identified could dramatically improve transfusion safety. Thus, the goals of this session are: 1) to familiarize practitioners with the concept of alloantibody responders by formulating a definition of the 'responder patient' and identifying known clinical/biological factors associated with alloantibody development, 2) to review recent advancements in animal models which have helped improve understanding of the immune response to RBC transfusion, and 3) to discuss the strengths and limitations of traditional approaches to dealing with responder patients, as well as highlight the potential that RBC genotyping offers in mitigating alloimmunization. (9219-S) Recent Advances in IvIg and IvIg Substitutes Director/Moderator: Alan Lazarus, PhD Speaker: Robert Skeate, MD; Alan Lazarus, PhD; Donald R. Branch, BS, MT(ASCP)SBB, PhD Intended Audience: Physicians, Scientists, Technologists Teaching level: Intermediate to Advanced Objectives: Discuss how IVIg is made and how it is used in the clinic. Discuss recent advances in mechanisms of IVIg action in autoimmune states. Discuss recent advances in IVIg substitutes. Event Description: Intravenous immunoglobulin (IVIg) is produced from the plasma of thousands of healthy blood and plasma donors. It is an expensive and limited resource which is used to treat a wide spectrum of inflammatory diseases and autoimmune states. Although it is considered to be generally safe, there will always be the theoretical risk of transmission of emerging pathogens. This session will provide an introduction to IVIG; what it is, how it is made, and how it is used in the clinic. Recent advances in our understanding of how IVIG works to ameliorate autoimmune disease will next be covered and finally current work on IVIG substitutes will be presented. (9221-TC ARS) Massive Transfusion: What Have You Done For Me Lately? Director: Jay Raval, MD Moderator: Darrell Triulzi, MD Speaker: Jay Raval, MD; Mark Yazer, MD; Matthew Neal, MD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 34 Objectives: Explain why massive transfusions are clinically important, what patient populations may require massive transfusions, and what types of massive transfusion protocols exist for different patients. Describe the familiar as well as emerging evidence in massive transfusion, the unique blood components/ratios involved, and AABB's position on massive transfusion. Recognize how non-trauma patients are impacted by massive transfusion protocols and the evidence associated with this type of transfusion in this unique patient population. Event Description: Massive hemorrhage is an important and clinical disastrous finding that immediately impacts the blood bank. However, multiple patient groups, including trauma, OB/GYN, and other non-trauma patients, have been the recipients of massive transfusion protocol activations and transfusions. This session will illustrate the heterogeneity in massive transfusion protocols and the evidence to support their use in various trauma and non-trauma patient populations. (9222-TC ARS) Hogwarts School of Antigens and Antibodies Director/Moderator: Susan Johnson, MSTM, MT(ASCP)SBB Speaker: Jayanna Slayten, MS, MT(ASCP)SBBcm; Monica Kalvelage, MT(ASCP)MB, SBB; Rebecca Coward, MT(ASCP)SBB Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Discover how others approach serological testing problems. Utilize efficient and reliable processes for problem resolution. Learn the latest information on serological testing. Event Description: All aboard Hogwarts Express as you enroll in AABB's Hogwarts School of Antigens and Antibodies. Medical Laboratory Scientists/Technologists will be challenged to demonstrate their blood bank wizarding skills in this Harry Potter inspired series of interactive case studies. Students will be presented with pretransfusion/prenatal test scenarios to practice their antibody identification magic, receive problem solving approaches from Hogwarts house faculty, and learn serologic practices from fellow blood bank professionals as all witches and wizards are encouraged to share their spells and potions using interactive audience response. "Graduate" from the school with new and/or refreshed serological knowledge. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 35 (9223-TC) Organ on Demand: Where Are We With 3D Printing Director/Moderator: Pampee Young, MD, PhD Speaker: David Kolesky, PHD; ngela Panoskaltsis-Mortari, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: What is 3D bioprinting and its challenges. Discuss 3D bioprinting complexities, such as the choice of materials, cell types, growth and differentiation factors, and technical challenges related to the sensitivities of living cells and the construction of tissues. Addressing these complexities requires the integration of technologies from the fields of engineering, biomaterials science, cell biology, physics and medicine. Application of 3D bioprinting in organ on a chip as tissue models for research and drug discovery. Event Description: Three-dimensional (3D) printing, is driving major innovations in many areas, such as engineering, manufacturing, art, education and medicine. Recent advances have enabled 3D printing of biocompatible materials, cells and supporting components into complex 3D functional living tissues. 3D bioprinting is being applied to regenerative medicine to address the need for tissues and organs suitable for transplantation. Other applications include developing highthroughput 3D-bioprinted tissue models for research, drug discovery and toxicology. (9224-QE-IT) Clinicians' and Health Care Providers' Access to Transfusion Medicine Information in the era of Information Technology and the Electronic Health Record Director/Moderator: Yunchuan Delores Mo, MD, MSc Speaker: Gay Wehrli, MD; April Hord, BB(ASCP), BS, MS, SBB; Arnethea Sutton, BS, MS, MT(ASCP) Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, Perfusionists Teaching level: Basic to Intermediate Objectives: The participant will learn steps involved to gain support for creating a method to access transfusion medicine (TM) information in an electronic health record (EHR). The participant will identify the TM key points to include in this EHR accessible location. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 36 The participant will discover the testing involved ensuring that the TM information displays as intended in the EHR and the post implementation monitoring involved after the go-live process. Event Description: During this program the attendee will learn from several transfusion services how they implemented electronically accessible transfusion medicine information for clinicians and other health care providers. Topic will include the why there is a need for health care providers to have easily accessible and up to date transfusion medicine information, from patient safety to patient blood management. The session will address: (1) the steps taken and challenges faced when creating an accessible electronic TM site, (2) how to golive with the TM site and measure success after implementation, and (3) the positive impact a TM site has for the blood bank and transfusion medicine services and for the health care providers will be presented. (9225-QE) Laboratory Developed Tests; Regulatory Update in a Growing World of Personalized Medicine Director/Moderator: Jed Gorlin, M.D., M.B.A. Speaker: Kevin Halling, MD, PhD; Carla Cuthbert, Ph.D. FACMG, FCCMG Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate Objectives: Describe circumstances where use of novel unlicensed products may be required, including the treatment of Jehovahs Witness patients. Describe the FDA approval process for an emergency IND. Describe limitations to the therapeutic conclusions that can be drawn from uncontrolled usage of unlicensed products. Event Description: This session would provide an overview of the regulatory framework for lab-developed tests used in clinical settings and the proposed FDA draft guidance, as well as impact to developing field of personalized medicine, with some real-life examples/ implications. (9226-LMT ARS) Messaging, Managing and Motivating How to Mobilize People and Operationalize Behaviors in Times of Change Director/Moderator: Vicki Finson, MT(ASCP)SBB Speaker: Vicki Finson, MT(ASCP)SBB; Melinda Bryant, M-PM, PMP; Susan Williams, MBA, CPBA Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 37 Provide a strategic framework of leadership practices that drive successful navigation through organizational transitions. Outline the predicable phases of learning, growth and change and how to manage them. Present managerial tools and behavioral techniques for leading and motivating an organization through periods of ambiguity and uncertainty (i.e., periods of transition). Event Description: This session is an engaging and interactive experience designed to help leaders at every level to explore what works (and what doesn't) in leading themselves, their teams and their organizations through change. The conversation will be founded in both theory and application, providing practical solutions that are based on relevant examples from present-day case studies. Participants will be invited to 1) perceive their own change experiences as both an individual and a leader from an operational perspective, 2) explore various tools and techniques around messaging, managing and motivating through transition, and 3) craft a clear and intentional plan for moving forward with impact. Note: Because great leaders of change can operate within any role of an organization, we encourage those in non-managerial roles to attend this session as well. 2:00 p.m. - 4:00 p.m. (9237-TC-PBM) Clinical Practice Guidelines from the AABB: Red Blood Cell Transfusion Thresholds and Storage Director/Moderator: Aaron Tobian, MD, PhD Speaker: Aaron Tobian, MD, PhD; Jeffrey Carson, MD; Nancy Heddle, MSc, FCSMLS(D) Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Intermediate Objectives: Determine why AABB drafts clinical practice guidelines and how AABB applies GRADE methodology to draft guidelines. Evaluate the medical evidence for the optimal target hemoglobin for red blood cell (RBC) transfusion of hospitalized hemodynamically stable adult patients and discuss AABB's recommendation. Evaluate the medical evidence for the length of time RBCs should be stored prior to transfusion and discuss AABB's recommendation. Event Description: Over 100 million units of blood are collected worldwide each year, yet the indication for RBC transfusion and RBC storage time remains uncertain. Large randomized clinical trials (RCTs) provide new evidence to guide RBC use. This fall the 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 38 AABB published RBC transfusion guidelines. This session will provide the background for why AABB drafts clinical practice guidelines, describe the guideline development process, assess the randomized trial evidence and discuss the recommendations. 2:00 p.m. - 5:30 p.m. (9220-TC ARS) Temas de Actualidad en la Medicina Transfusional Director: Dolores Figueroa, MT(ASCP)SBB Moderator: Nancy Benitez, MHS (ASCP) SBB Speaker: Marina Bueno, MLS(ASCP) CMSBBCM; Marisela Marchan, MT(ASCP)SBB; Celina Montemayor, MD PhD; Dolores Figueroa, MT(ASCP)SBB Intended Audience: Physicians, Technologists Teaching level: Intermediate to Advanced Objectives: Revisar aplicaciones de la biologa molecular en Immunohematologia y su utilidad para resolver casos clnicos. Discutir las nuevas recomendaciones para el manejo de pacientes con el Fenotipo RhD dbil. Revisar la metodologa de algoritmos computacionales para la seleccin de plaquetas en el paciente refractario y avances en inactivacin de patgenos en componentes sanguneos. Event Description: En este taller, expertos en diversas reas de la Medicina Transfusional revisaran temas de actualidad. Se discutirn temas de biologa molecular aplicada a los grupos sanguneos y plaquetarios, y aplicaciones de los mtodos moleculares en el banco de sangre. Se discutir la futura aplicacin de los mtodos de secuenciacin de nueva generacin, y la posible contribucin de los pases latinoamericanos en el nuevo campo de Bioinformtica de clulas rojas. Adems se revisaran avances en la inactivacin de patgenos en componentes sanguneos y el uso de algoritmos computacionales para la seleccin de plaquetas en pacientes refractarios. Tambin se discutirn con los participantes casos immunohematolgicos que ejemplifican como la biologa molecular y la serologa se complementan. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 39 4:00 p.m. - 5:30 p.m. (9227-TC) Interactive Case Studies in Perioperative Bleeding Management Director/Moderator: Melissa Cushing, MD Speaker: Melissa Cushing, MD; Thorsten Haas, MD; Evelyn Lockhart, MD; James Iqbal, MD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, Perfusionists Teaching level: Basic to Intermediate Objectives: Provide brief overview of viscoelastic testing and compare the role of viscoelastic testing in bleeding management to that of traditional laboratory testing. Diagnose and recommend treatment in difficult cases of ongoing or refractory bleeding. List scenarios where viscoelastic testing may not be useful. Event Description: This will be an interactive case-based session on the use of viscoelastic testing to diagnose and treat bleeding in various clinical scenarios, including intraoperative, postoperative and intensive care settings. The speakers will use the audience response system to engage attendees and generate discussion. The pros and cons of viscoelastic testing will be analyzed. The risks and benefits of various treatment approaches will be compared. (9228-TC-CT) Choosing a Stem Cell Donor When There Are no Matched Donors Director/Moderator: Kaaron Benson, MD Speaker: Ernesto Ayala, MD; Taiga Nishihori, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: To identify the options available to hematopoietic stem cell transplant (HSCT) patients who do not have an HLA-matched donor To briefly describe the process for haploidentical donor HSCT and patient outcomes To briefly describe the process for cord blood and mismatched unrelated donor HSCT and patient outcomes 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 40 Event Description: Patients with life-threatening hematologic malignancies may be cured with hematopoietic stem cell transplant (HSCT). The best outcomes are with perfectly HLA-matched donors but about 25% of whites and up to 80% of other racial and ethnic groups have no HLA-A, HLA-B, HLA-C, HLA-DRB1 identical donor. Alternatives to full HLA-matched donor HSCT include use of haploidentical donors, cord blood and mismatched unrelated donors (MMUD). Haploidentical donors are available for most patients as they include all first-degree relatives, e.g., parents, children and 50% of full siblings. As matching requirements are less stringent for cord blood, many patients are eligible but interest in this donor source has waned. MMUD are also commonly available for patients in need. This program will review these options and describe the process for each of the three types of alternatives to full HLA-matched HSCT and review patient outcomes to date. (9229-TC-RC-HEM) Hemovigilance for Blood Collectors Director: Barbee Whitaker, PhD Moderator: Kevin Land, MD Speaker: Mary Townsend, MD; Barbee Whitaker, PhD; Kevin Land, MD; Mark Fung, MD, PHD; James Stubbs, MD Intended Audience: Physicians, Nurses, Managers/Supervisors, Perfusionists Teaching level: Intermediate Objectives: To describe trends in Donor Hemovigilance through presentation of 20122014 Donor Hemovigilance data reported to AABB. To demonstrate the harmonized adverse reaction form for hospitals to use in reporting reactions to blood centers. To report on the validation of the internationally harmonized definitions for blood donor reactions. Event Description: This session will address hemovigilance for blood collectors. Trends in blood donor hemovigilance will be discussed. The role of the blood collectors in monitoring and encouraging transfusion reaction reporting through use of a common reaction reporting form will be reviewed. Internationally harmonized donor adverse reaction definitions and their validation will be described. (9230-QE) Crucial Conversations: Strategies for Maintaining Professionalism and Enhancing Communication Between the Transfusion Service and Clinical Teams Director/Moderator: Theresa Nester, MD Moderator: Deborah Sesok-Pizzini, MD, MBA Speaker: Nancy Dunbar, MD; Mark-Alan Pizzini, MD Intended Audience: Physicians, Nurses Teaching level: Basic to Intermediate Objectives: 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 41 Review concepts of professionalism and how to recognize when you or others are "out of role." Discuss educational programs that engage pathology residents to have a visible presence in the hospital. Generate ideas of enhancing communication between the transfusion service and clinical teams using blood. Event Description: This session is intended to share ideas for curriculum development, both for pathology residents and for other residents likely to use blood as part of their daily work. Time spent sharing knowledge during the day with clinical colleagues can make those difficult 2am conversations much easier, or even eliminate those conversations that arise from a knowledge gap. When these difficult conversations do arise, it is important to maintain professionalism. This session will highlight strategies for helping trainees to maintain focus on the patient in a professional way, and for educating clinicians to understand common goals related to optimal transfusion support. (9231-QE ARS) Test Your Blood Bank Knowledge Director/Moderator: Jayanna Slayten, MS, MT(ASCP)SBBcm Speaker: Karen Byrne, MDE, MT(ASCP)SBB; LeeAnn Walker, MEd, MT(ASCP)SBB; Lorraine Blagg, MA, MLS(ASCP)SBB; Stacey Alvey, MEd, MT(ASCP)SBB; Kate Hernandez, MT(ASCP)SBB Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Review basic to advanced knowledge in blood banking/transfusion medicine. Using the ASCP SBB/BB categories and content outline as the basis, challenge participants to recall technical, scientific and management information. Provide entertainment while allowing participants to assess their knowledge. Event Description: Using a modified "Jeopardy" game show format and in the spirit of friendly competition, multiple-choice questions will be presented to the audience in categories corresponding to the ASCP SBB and BB exam content outlines. Responses will be tallied by audience response technology and final scores will be announced to the competing teams. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 42 (9232-LMT ARS) Voice of the Customer: Can You Hear Me Now? Director/Moderator: Jeffrey Schuh, BA Speaker: Jeffrey Schuh, BA; Jennifer Sanders Intended Audience: Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Introduce Voice of the Customer and its importance in business decision making. Discuss BSIs incorporation of VOC when interacting with outside customers. Demonstrate the internal use of VOC when deciding on the next generation of Self Contained Units (buses, coaches, trucks). Event Description: Voice of the Customer (VOC)is a tool used by businesses to understand and anticipate the needs and wants of their customers. Realizing that VOC is more than just annual surveys, Blood Systems Blood Center Division chartered and completed a project to expand the number, type and analysis of information gathered when talking to our various external customers. In addition, VOC was used internally as an important part of a new vehicle design and selection process. (020A) Scientific Oral Abstract Session: Recipient Non-Infectious Adverse Events (020B) Scientific Oral Abstract Session: Transfusion Practice I (020C) Scientific Oral Abstract Session: RBC Molecular Testing and Genetics 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 43 6:00 p.m. - 7:30 p.m. ----------------------------Research and Progress (RAP) Sessions The RAP sessions focus on new developments, rather than review general topics, and will convene experts in each area under discussion. Formal presentations are limited, emphasis will be on discussion and sharing of experiences among all attendees. The sessions will be held simultaneously. All RAP sessions are available for CME credits. Beverages and light hors d’oeuvres will be available for attendees at these sessions. ----------------------------(9233-TC-CT) Research and Progress (RAP) Sessions: New Horizons for Graftversus-Host Disease Director: Jay Raval, MD Check back for topic and a detailed description. (9234-TC) Research and Progress (RAP) Sessions: Inside Job or Outsourced — Transfusion Service Operational Options Check back for topic and a detailed description. (9235-TC) Research and Progress (RAP) Sessions: Little People with Low Platelets: Which Neonates Benefit from Prophylactic Platelet Transfusions? Check back for topic and a detailed description. (9236-TC Research and Progress (RAP) Sessions: Is it Time to Revisit the Concept of ABO "Universal Donor" Red Cells and Plasma? Check back for topic and a detailed description. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 44 MONDAY, OCTOBER 24, 2016 8:30 a.m. - 10:00 a.m. (9302-TC-CT) Best Practices from the Cellular Therapy Quality Ops Subsection Director/Moderator: Kathleen Fortune, MT(ASCP) Speaker: Shilpa Choudhari, MS, CQA (ASQ); Itzia Iglesias, MS Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Showcase time tested practices in Quality operations. Present practical and useful solutions to quality problems in cellular therapy. Event Description: Best practices in a variety of areas will be presented. These best practices have been chosen by the leadership of the cellular therapy quality operations subcommittee from presentations given at the subcommittee monthly meetings. Audience participation will be encouraged so come prepared with your own "best practices." (9303-QE-CT) CLIA for CT Labs: What Applies, When and Who is Responsible Director/Moderator: Lisa Phillips Johnson, MT(ASCP)SBB, CQA, CMQ/OE, RAC Speaker: Lisa Phillips Johnson, MT(ASCP)SBB, CQA, CMQ/OE, RAC; Lizette Caballero, MLS (ASCP)CM; Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ) Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Provide an overview of CLIA regulations / requirements, specific to CT labs. Explain proficiency testing, competency assessments and other responsibilities for CT labs. Provide some examples of lab processes in place to support these requirements. Event Description: This session would provide an overview of CLIA requirements and resources available for CT labs, explaining clinical use of tests vs product testing. An overview of the need for proficiency testing, competency assessments and other aspects of quality system requirements for labs would be discussed, as well as staffing qualifications and responsibilities. Speakers will include examples of application to round out this session. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 45 (9304-QE) Blood Bank Proficiency, Competency and QC: A Practical Approach to CLIA Requirements and AABB, CAP and Joint Commission Expectations Director: Dickie Nichols, MT(ASCP)SBB Moderator: Dawn Rumsey, ART(CSMLS) BB(ASCP) Speaker: Denise Driscoll, MS, MT(ASCP)SBB; Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ); Heather McGann, MT(ASCP) SBB; Stacy Olea, MT(ASCP), FACHE Intended Audience: Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Discuss the relationships between the laboratory, CLIA and deemed status Accrediting Organizations and Bodies. Clarify requirements for IQCP. Describe and compare the criteria for Competency, Proficiency and QC of three of the deemed status. Accrediting Organizations based upon CLIA requirements. Event Description: Illustrate methods used by a transfusion service for fulfilling these requirements. (9305-LMT) Disruptive Forces and Critical Success Factors in Healthcare Director: Jean Stanley, MBA, MT(ASCP)SBB, CMQ/OE(ASQ) Moderator: JoAnn Hegarty, MT(ASCP)SBB, MT(ASCP)SBB Speaker: Robert Michel; Rick Panning, MBA, MLS(ASCP)CM Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate to Advanced Objectives: Explain the ten disruptive forces that are impacting healthcare today. Recognize how critical success factors rely on a commitment to and capacity for reinvention and innovation. Identify critical success factors that blood centers should consider in leveraging their relationship with hospitals. Event Description: Disruptive forces in healthcare provide challenges to both hospitals and blood centers. Healthcare leaders will need to address these forces in their strategies if they intend to realize sustainability and continue growth in a significantly changing marketplace. Hospital and blood center leadership also need to recognize the importance of critical success factors which include issues vital to an organization's current operating activities, and require a commitment and capacity to provide special and continual attention to bring about future 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 46 success. These critical success factors are especially important as blood centers struggle to maintain a balance between assisting hospitals with better patient blood utilization and financial sustainability. Come learn about these disruptive forces and how the relationship between hospitals and blood centers can be leveraged to meet these challenges. (9306-LMT) Staffing to Workload Director/Moderator: Karafa Badjie, MS, MLS(ASCP)SBB, BMLSc Speaker: Karafa Badjie, MS, MLS(ASCP)SBB, BMLSc; Theresa Downs, MT(ASCP)SBB, CQA(ASQ); Joy Gomez; Raymond Frick Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Intermediate Objectives: Discuss data driven methods to capture workload. Develop staffing models to align laboratory staffing with workload demand. Improve FTE productivity by aligning staffing with the workload demand to reduce turnaround times. Event Description: The interactive workshop will focus on a data driven and systematic approach to understand demand, identify idle time, and optimize work schedules. The workshop will examine the different variations that exist when performing staffing to workload analysis. Case studies will be utilized to generate ideas. Tools will be provided to complete the analysis. (030A) Scientific Oral Abstract Plenary Session (9332-S-HEM) Results from the 2015 Blood Surveys Director: Barbee Whitaker, PhD Moderator: Steve Kleinman, MD Speaker: Barbee Whitaker, PhD; Kathryn Haass, MPH, CPH, MT(AAB), BB(ASCP)M Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: Review the trends in blood collection and utilization in the United States and among AABB members. Describe differences in sampling and survey methodologies of national and member surveys which may impact collection and utilization estimates. Compare results to 2013 surveys. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 47 Event Description: This session will include presentations from the surveys designed to estimate blood collection and utilization in the United States form 2015 data. AABB will present findings from the 2015-2015 AABB Blood Collection and Utilization Survey of member facilities. The CDC will present findings from the 2015 HHS National Blood Collection and Utilization Survey. 10:30 a.m. - 12:00 p.m. (9308-S) Does Blood Transfusion Prevent Aging? Director/Moderator: Jose Cancelas, MD, PhD Speaker: Hartmut Geiger, PhD; James Ferrara, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Learn how stem cell aging is affecting the basic biology of immune reconstitution and the incidence, prevalence and prognosis of graftversus-host disease of allogeneic stem cell transplantation recipients. Event Description: Stem cell aging impacts the clinical outcome of stem cell transplantation by reduced potency, myeloid differentiation bias, decreased ability to support lymphopoiesis and reduced immunocompetence. Host aging is impacting the incidence and severity of graft-versus-host disease. This session will provide an update on recent findings in the biology and treatment of agingrelated complications in the context of stem cell transplantation. (9309-S) The Role of Platelet and Coagulation Activation in Sickle Cell Disease AABB/ASH Joint Program Director/Moderator: Patricia Shi, MD Speaker: Ted Wun, MD; Nigel Key, MD Intended Audience: Physicians, Scientists, Nurses Teaching level: Intermediate to Advanced Objectives: Discuss the pathophysiology and role of platelet and coagulation activation in sickle cell disease. Demonstrate understanding of the role of cell-derived microparticles in vaso-occlusion and allo-immunization. Critically evaluate ongoing and potential clinical studies in these areas. Event Description: This session will review the pathophysiology and role of platelet activation in sickle cell vaso-occlusion in light of the pasugrel trial, the 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 48 current understanding of the pathophysiology and role of coagulation activation, and the interplay of the two with heme and cell-derived microparticles. The potential benefit of further clnical studies in these areas will be discussed. (9310-S) The ABCs of transfusion-related hypotension: Anaphylaxis, Bradykinin, and Contamination Director/Moderator: Aaron Tobian, MD, PhD Speaker: William Savage, MD, PhD; Monica Pagano; Richard Benjamin, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate Objectives: Review the pathophysiology, epidemiology, and treatment of hypotensive transfusion reactions. Review the pathophysiology, epidemiology, and treatment of hypotension in septic transfusion reactions. Review the pathophysiology, epidemiology, and treatment of hypotension in anaphylactic transfusion reactions. Event Description: Hypotension is an uncommon, but life-threatening complication of transfusion that requires emergent treatment. This course will review the differential diagnosis of hypotension in the setting of transfusion and describe in depth the distinct pathophysiology of hypotension in three unrelated transfusion reactions. Hypotensive, septic, and anaphylactic reactions can share hypotension as a presenting sign, although the pathways that lead to hypotension are largely distinct. An understanding of the distinct pathways involved will illustrate why risk factors and treatments differ among these causes of hypotension. (9311-TC) Ask the Standards Director/Moderator: David McKenna, MD Speaker: Patrick Ooley, MS, MT(ASCP), CQA(ASQ)CMQ/OE; Mary Berg, MD; Richard Haspel, MD, PhD Intended Audience: Physicians, Scientists, Technologists Teaching level: Intermediate to Advanced Event Description: Presentations will be given by standard subcommittee chairs regarding standards in his or her discipline. Questions for the discussion are to be submitted before the scheduled session via the AABB website starting late August and during the session. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 49 (9312-TC) Clinical Challenges of Chimerism Director: Nicole Draper, MD Moderator: Mary Berg, MD Speaker: Nicole Draper, MD; Joel Kniep, MD; Shalini Shenoy, MD Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Discuss causes of congenital and acquired macro- and microchimerism in humans. Apply concepts of chimerism to make clinical diagnoses. Use information about chimerism to predict clinical outcomes and choose between treatment options. Event Description: With the increasing frequency of organ and hematopoietic progenitor cell transplantation, the population of chimeric individuals is also rising. An understanding of the causes of chimerism and the clinical implications for transplantation and transfusion is needed to properly care for these chimeric patients. Chimerism poses a special challenge for transfusion of blood products because it can lead to typing discrepancies and unexpected antibodies. Additionally, blood products need to be chosen based on compatibility with the host and the graft. Congenital chimerism is often discovered due to abnormalities on ABO typing or HLA typing as part of the transplantation process. Example cases will be used to illustrate concepts such as congenital chimerism identified by HLA typing, the importance of chimerism in HSCT for sickle cell disease, transfusion in ABO and Rh mismatched HSCT, and passenger lymphocyte syndrome after solid organ transplantation. (9313-TC) Roundtable Discussions for Molecular Immunohematology Professionals Director: Greg Denomme, PhD Moderator: Bill Flegel, MD Speaker: Maryse St-Louis, PhD; Dan Waxman, MD; Christopher Tormey, MD; Lilian Castilho, PhD; Silvano Wendel, MD, PhD; Gary Stack, MD, PhD; Margaret Keller, PhD; William Lane, MD, PhD; Ellen Klapper, MD; Christof Weinstock, MD; France Pirenne, MD, PhD; Qing Chen, MD; Bill Flegel, MD Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Network with laboratory and clinical professionals who have an interest in molecular immunohematology and blood group genetics. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 50 Compare and contrast challenging or controversial concepts in immunohematology. Meet and interact with world leaders in molecular immunohematology. Event Description: The molecular immunohematology roundtable workshop returns for another year! This session has resulted in three publications in previous years that summarized the comments and opinions of you, the immunohematology professional. Modeled on a speed dating format, the event will consist of small group discussion led by "chaperones", who act as scribes for the participants. The year's session will consist of thesis statements for groups of 8 to 10 participants who will compare and contrast their ideas and opinions. Chaperones will move from one table to another to facilitate discussion. At the conclusion, the chaperons give a short summary. For the inexperienced immunohematologist, it is an opportunity to become familiar with a new field and to forge professional friendships. For the seasoned professional, it's an opportunity to share experiences and swap ideas. Join us and look for your collective opinions to appear in print. (9314-TC-CT) Adverse Events and Specific Stem Cell Products Director/Moderator: Jay Raval, MD Speaker: Laura Cooling, MD, MS; Rebecca Haley, MD; David Maloney, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Describe the unique complications that can occur with the infusion of HPC,Apheresis and HPC,Marrow products and how to manage/prevent them. Describe the unique complications that can occur with the infusion of HPC,Cord products and how to manage/prevent them. Recognize the unique complications that can occur with the infusion of CAR T cells and how to manage/prevent them. Event Description: It is important to recognize that unique complications exist with the infusion of unique stem cell products. With the increased use of HPC, Cord products, increased ABO-incompatible HPC, Marrow products, cryopreserved HPC, Apheresis products, and CAR T cell therapies, increased numbers of complications are being observed that are associated with each of these unique products, including (but not limited to) stunned heart syndrome, hemolytic reactions, granulocyte/DMSO toxicities, and cytokine release syndrome, respectively. In this session, the goal is to characterize and explain why certain complications occur with unique stem cell products, how these 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 51 complications can be managed/prevented, and how tracking/recording/reporting of these complications is critical to product improvement and recipient safety. (9315-TC) Interference with Blood Compatibility Testing by Monoclonal Antibody Therapy — What, Why and How to Resolve Director/Moderator: Joseph Schwartz, MD, MPH Speaker: Richard Kaufman, MD; Jacob Laubach, MD; Karen De Vooght, PhD Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Outline the preclinical and clinical data for monoclonal antibody therapy, specifically daratutumab (DARA) and other anti-CD38 antibodies, and the potential therapeutic applications of anti-CD38 beyond multiple myeloma. Review the blood banking testing and the interference observed when daratutumab (DARA) is being used as a therapeutic modality and currently existing techniques to resolve it such as using DTT-treated red blood cells or genotyping. Understand the potential techniques that are in development in order to resolve the interference — e.g. using anti-idiotype antibodies to neutralize anti-CD38 in vitro. Event Description: Monoclonal antibodies are increasingly being used in the care of patients with a variety of conditions including malignancy, infection and inflammatory diseases. The interference of monoclonal antibodies with clinical laboratory tests is an emerging concern that requires both recognition and the development of appropriate solutions. Daratumumab (DARA), a novel anti-CD38 monoclonal antibody is being developed to treat patients with multiple myeloma. While in clinical trials, its use resulted in interference with routine blood banking compatibility testing which might preclude the correct identification of irregular blood group antibodies for patients requiring blood transfusion. Therefore, developing solutions to overcome this interference is critical for patient safety. This session will provide an introduction to monoclonal antibody therapy, with a focus on DARA and other anti-CD38 antibodies. The potential therapeutic applications of anti-CD38 in multiple myeloma and beyond will be discussed. The blood bank testing affected by the DARA interference will be described, along with possible solutions to overcome the interference using currently available techniques. Finally, a review of potential future techniques to resolve the interference, such as using anti-idiotype antibodies to neutralize anti-CD38 in vitro, will be provided. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 52 (9316-QE) What's Wrong With This Picture...Auditing and Finding Quality Problems in the Transfusion Service Director/Moderator: Regina Castor, BS, MT(ASCP)SBB Speaker: Rosemary Steuber, MT, SBB(ASCP) Intended Audience: Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Describe items to consider including in auditing the Transfusion Service. Understand examples of errors that can be uncovered in the auditing process. Learn strategies for improving the auditing process. Event Description: This session will provide examples of items uncovered during auditing processes. Examples of "What can go wrong" will be shared. Through these examples, strategies for improving auditing and improving quality processes will be shared. Examples will include equipment audits, instrument and reagent audits, and form design among others. By sharing some of the pitfalls experienced by peers, learn how to avoid the mistakes of others. (9317-QE) Revision to 21 CFR Part 600 Impact to Donors and Blood Center combined w/ Implementing the Final Rule Director/Moderator: Roxanne Tata, MT(ASCP)SBB, CQA(ASQ) Speaker: Galen Kline, BS, CLSSBB; Elizabeth DeAngelo; Chelsea Sheppard, MD Intended Audience: Physicians, Scientists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Understand the changes required with the implementation of the Final Rule for 21CFR, Part 600 requirements for blood and blood components for future manufacturing use. Understand the changes related to donor deferral record keeping, donor suitable changes and review of the data since implementation of changes. Review and understand the role and responsibility of the blood center physician. Review the changes related to testing frequency for future flexibility. Event Description: The implementation of the long awaited rule affecting 21CFR Part 600, Requirement for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (Final Rule) has had significant impact on operations and blood centers. This program will review changes, show how blood centers have implemented changes and review current data from the implemented changes. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 53 (9318-LMT) Bleeding Edge Information Solutions for Transfusion Medicine Director: Ronald Hardin Moderator: Liz Carter, MT(ASCP)SBB, CQA Speaker: Martin Morey; Ronald Hardin; Kevin Harrington Intended Audience: CEOs/CFOs Teaching level: Intermediate to Advanced Objectives: Identify what capabilities health care organizations need to build digital leadership. Provide a blueprint for project planning and execution of a data management strategy. Discuss actionable insights to the software tools evaluation & selection process. Event Description: This session provides practical solutions and actionable advice for blood bank executives. In today’s healthcare environment organizations will need a robust digital strategy to remain competitive. To reach this level you need an approach to data management that empowers people to build the analytics they need to improve their business insights. Industry professionals will share challenges and successes in the journey to creating an enterprise data warehouse and big data solutions. Time will be provided at the end of presentation to ask questions. (9319-LMT) Organizational Integration: Successes, Challenges and Lesson's Learned Director/Moderator: Mary Lieb, BS, MT(ASCP)SBB, CQA(ASQ) Speaker: Tammy Croak-Wilson, MT(ASCP)SBB; Vicki Finson, MT(ASCP)SBB; Alexander Socarras Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Intermediate to Advanced Objectives: Describe the similarities and differences presented in each approach taken for effective integration in mergers and acquisitions. Identify the successes and challenges encountered in each approach presented for integration in newly aligned organizations. Discuss the lessons learned identified in each of the presentations that will allow for better organizational integration. Event Description: Mergers and acquisitions are an industry trend creating a paradigm shift in health care delivery. There are many strategies and activities to 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 54 achieve successful integration of newly aligned organizations. Three scenarios will be presented from the vendor, hospital and blood center perspective for organizations that are currently involved in organizational integration. Similarities and differences in philosophy, approach and implementation of integration activities will be discussed. Successes and challenges including "lessons learned" will be addressed in each presentation. An opportunity for questions and answers will be provided at the conclusion of the presentation. 2:00 p.m. - 3:30 p.m. (9321-TC) Clinical Manifestations, Etiology, and Pathogenesis of Hyperhemolysis: Time to Start a Registry! Director: Karina Yazdanbakhsh, PhD Moderator: France Pirenne, MD, PhD Speaker: Karen King, MD; France Pirenne, MD, PhD; Sally Campbell-Lee, MD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Intermediate Objectives: To describe clinical features of hyperhemolyis in patients with sickle cell disease and its management. To describe potential risk factors associated with hyperhemolyis and new treatment options. To discuss a proposal to build an international, multi-center Hyperhemolysis Registry. Event Description: Patients with sickle cell disease receiving transfusions can experience hyperhemolysis, a life-threatening poorly understood phenomena in which the transfused and the patient's own red blood cells (RBCs) are destroyed. This type of hemolytic reaction is unpredictable and potentially under-recognized because its clinical presentation may resemble pain crisis. Due to the small numbers of patients that are encountered at individual hospitals and centers, the prevalence of hyperhemolysis amongst SCD remains imprecise. Development of new or reactivation of alloantibodies together with clinically relevant autoantibodies may explain hyperhemolysis trigger in some cases; however, hyperhemolysis can occur in the absence of detectable alloantibodies or autoantibodies; yet little is known about the etiology of hyperhemolysis in such cases or the clinical and laboratory features that may distinguish hyperhemolysis subgroups. Studies to elucidate their underlying mechanism of hyperhemolysis, are critical for SCD patient care. In this session, Dr. Karen King will review some of the clinical features of hyperhemolyis and its management. Dr. Pirenne will describe potential risk factors associated with hyperhemolyis and new treatment options. Dr. Sally Campbell-Lee will discuss a proposal to build an international, 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 55 multi-center Hyperhemolysis Registry as a first step to assess prevalence, clinical and laboratory features of hyperhemolysis. (9322-TC) Highlights from the American Society for Apheresis (ASFA) Guidelines on the Use of Therapeutic Apheresis in Clinical Practice, 7th Edition AABB/ASFA Joint Program Director: Jill Adamski, MD, PhD Moderator: Lance Williams, MD Speaker: Nicole Aqui, MD; Joseph Schwartz, MD, MPH; Anand Padmanabhan, MD, PhD, MA, Tina Ipe, MD, PhD Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Describe the history and methodologies used to create the 7th edition of apheresis guidelines. Review critical updates in for previously published clinical indication fact sheets. Introduce fact sheets for the therapeutic apheresis indications that are appearing for the first time in the 7th edition. Event Description: The ASFA Journal of Clinical Apheresis (JCA) Special Issue Writing Committee performs a rigorous review of the published literature relating to therapeutic apheresis in the interval between the JCA apheresis guidelines special issues. Fact sheets are updated and new clinical indications are considered. Each indication is assigned a treatment category (I-V) and a strength of recommendation based on the GRADE system. The newest edition (7th) of the JCA apheresis guidelines will be presented during this session. Speakers will discuss methodologies used to classify clinical indications, the processes by which consensus categorizations/GRADE are assigned, important updates and changes from the 6th edition, and introduce fact sheets for new clinical indications. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 56 (9323-TC-CT) AABB/TERMIS-Americas Joint Program: Regenerative Medicine Therapies for Wounded Soldiers Director: James Yoo, MD, PhD Moderator: Anthony Ratcliffe, PhD Speaker: Kacey Marra, PhD; Simon Young, DDS, MD, PhD; James Yoo, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: Discuss approaches for translational applications in regenerative medicine. Describe unmet clinical needs and how regenerative medicine therapies are applied. Discuss clinical translation of regenerative medicine technologies for military. Event Description: Regenerative medicine focuses on the development of new approaches to repairing cells, tissues and organs for clinical applications. This session will provide insights into the rapidly evolving field of regenerative medicine. This session will highlight technologies that are being developed to help wounded soldiers with battlefield injuries. (9324-TC) Real World Application of Next Generation Sequencing in Transfusion Medicine Director/Moderator: Connie Westhoff, PHD, SBB Speaker: William Lane, MD, PhD; Stella Chou, MD; Connie Westhoff, PHD, SBB Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Objectives: To discuss the process used to determine red cell and platelet antigens from whole genome sequence. To present data comparing SNP testing to whole exome sequencing for RH genotyping. To stimulate discussion on how the use of genomic information might change our approach to pre-transfusion testing. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 57 Event Description: Typing for red cell and platelet antigens by targeting single nucleotide polymorphisms (SNPs) is now commonplace, but there are limitations especially for ABO and RH. Next generation sequencing is rapidly being applied in many areas of medicine. Individuals with hematologic malignancies and chronic illness may soon get routine whole genome sequencing for diagnosis or treatment. This data can be used in transfusion medicine. The speakers, who have published in this rapidly expanding field, will discuss their experience applying whole genome and exome sequencing approaches to determine blood group antigen expression and envision the future of pretransfusion testing in the era of genomics. (9325-QE) Creating a Successful Training Program for Today's Blood Bank Learner: Does it Have to be Electronic for Them to Pay Attention? Director: Karen Byrne, MDE, MT(ASCP)SBB Moderator: J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB Speaker: April Hord, BB(ASCP), BS, MS, SBB; Regina Castor, BS, MT(ASCP)SBB; Deirdre Parson, MS, MT(ASCP)SBB Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: Identify content development and requirements that need to be included in a training program to increase understanding and compliance. Review new insights into how to deliver effective training for today's learner. Summarize tools to measure the effectiveness of learning requirements. Event Description: Teaching today is very different from five to ten years ago. While the basis of content development may not change, how does one capture and hold the attention of today's learner? Are the social media tools of today a booster or a hindrance for today's instructor? Are lessons taught today effective for ensuring compliance with blood bank and cellular therapy regulations and safety requirements? The speakers in the session will answer these questions and share methods for successful training programs for today's learner. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 58 (9326-QE-CT) Aligning Hospital Strategy and Quality Initiatives in the Stem Cell Lab Director/Moderator: Deborah Sesok-Pizzini, MD, MBA Speaker: Yongping Wang, MD, PhD; Kathleen Fortune, MT(ASCP) Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: To describe methods for aligning hospital strategy with quality initiatives in the stem cell lab. To introduce new electronic methods for tracking and trending stem cell quality. To learn basic quality tools for reporting and reviewing quality in the stem cell lab. Event Description: Hospital strategic planning impacts decision making in the laboratory with regards to goal setting and program development. This also impacts stem cell quality initiatives which need to incorporate newer quality metrics and methods for monitoring these goals. In this session, we will describe examples to align strategic goals with quality metrics and review methods and tools used to monitor these metrics. (030B) Scientific Oral Abstract Session: Pediatric Transfusion Medicine (030C) Scientific Oral Abstract Session: Transfusion Practice II (030D) Scientific Oral Abstract Session: Components and Component Processing I (030E) Administrative Oral Abstract Session: Blood Management (030F) Administrative Oral Abstract: Management, Finance and General Marketing (030G) Administrative Oral Abstract Session: Collections and Product Manufacturing 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 59 4:30 p.m. - 6:00 p.m. (9327-TC-IT) iTransfusion: Using Informatics to Deliver Safer, Personalized Transfusion Therapy Director: Richard Kaufman, MD Moderator: Meghan Delaney, DO, MPH Speaker: Eric Krieg; Dee Townsend-McCall, RN, BSN; Lawrence Goodnough, MD; Michael Murphy, MD, FRCP, FRCPATH, FFPATH (M.) Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Assess the latest informatics tools for improving transfusion safety for blood ordering and nursing practice. Evaluate the resources and requirements to use informatics to improve laboratory practice in the transfusion service. Evaluate the impact of electronic decision support for transfusion on both clinical outcomes and blood use. Event Description: In this program, a broad multidisciplinary team of speakers (laboratory, nursing, and medical) will describe how novel information technology (IT) solutions have been employed to advance all aspects of transfusion care-from the blood bank to the bedside--through electronic process and decision support tools. (9328-TC-CT) Solve It! Scenarios in Cellular Therapy Director/Moderator: Michele Sugrue, MS, MT(ASCP)SBB Speaker: Michele Sugrue, MS, MT(ASCP)SBB Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Discuss creative solutions to manage common technical, clinical, and administrative challenges using case scenario approach. Review regulatory requirements and accreditation standards while developing strategies to resolve common hurdles in daily practices. Network with cellular therapy colleagues and experts in the field in a congenial and informal atmosphere. Event Description: With overwhelming enthusiasm, Solve It! Scenarios in Cellular Therapy returns to the AABB Annual Meeting, offering an interactive and productive program for Cellular Therapy Professionals. Recognizable case 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 60 scenarios will be presented in small groups followed by discussions and generation of potential resolutions. This program will allow attendees to select topics of particular interest and rotate through multiple scenario case presentations. The atmosphere is congenial and informal, and no preparation is needed! Join us for lively interactions and networking with fellow Cellular Therapy colleagues. (9329-TC) Personalized Transfusion Medicine: RH Genotype Matching Director: Margaret Keller, PhD Moderator: Sandra Nance, MS, MT(ASCP)SBB Speaker: Thierry Peyrard, PhD, PharmD, EurClinChem; Lilian Castilho, PhD; Margaret Keller, PhD; Greg Denomme, PhD Intended Audience: Physicians, Scientists, Technologists Teaching level: Intermediate to Advanced Objectives: Introduce the concept of RH genetic variation and expression of variant antigens and that multiple RHCE alleles may appear to have the same predicted phenotype. Present data on one or more RH alleles recently shown to express partial antigens and on their ability to identify donors to match patients with alloantibodies; some of the speakers will present alloimmunization data on patients receiving and not receiving RH-matched blood. Discuss the practical value of RHCE genotyping, how this information can be communicated to clinicians, and transfusion services staff and how the information can be used to identify potentially genocompatible donors. Event Description: Personalized Medicine in the field of Transfusion Medicine has impacted immunohematology testing, specifically RBC genotyping. Extended matching of blood group antigens has shown utility in reducing alloimmunization in transfusion recipients with sickle cell disease. However, Rh alloimmunization in this population continues to occur and can cause significant challenges to finding compatible blood. Genetic variation in the RH locus is very high in individuals of African descent and recent evidence shows that this genetic variation is the cause of a significant proportion of alloimmunizations among these patients. It is important for BB and TS staff are aware of the availability and utility of RH genotyping, as well as complex terminology of RHCE variants, as matching of donor and patient of African descent based on serologic testing alone often cannot detect the presence of variant antigens. This program will review the genetic variation of the Rh blood group system and summarize RBC genotyping of blood donors and patients. The session will use case studies to illustrate scenarios where patients with variant Rh antigens, including those with antibodies to high prevalence antigens hrS or hrB, can be more closely matched with donors through the use of RH genotyping. The speakers will present the 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 61 status of their programs to offer most compatible blood to patients with variant Rh antigens and alloantibodies. (9330-TC-CT) AABB/NMDP Joint Program: Global Perspectives on Quality and Biovigilance in Hematopoietic Cell Transplantation Director/Moderator: John Miller, MD, PhD Speaker: Bette Braem, MSSW, CMQ/OE (ASQ); John Miller, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: Examine the context and array of quality-related events associated with donor, patient and product safety in HCT manufacturing processes. Understand global biovigilance efforts for adverse event reporting for HCT donors and patients, including reporting requirements domestically and internationally. Describe the incidence of adverse events in HCT donors and how they may vary in unrelated donors of PBSC and marrow and in related donors. Event Description: Hematopoietic cell transplantation (HCT) provides life-saving cures for an increasing number of patients world-wide with a variety of malignant and non-malignant blood disorders. HCT is truly a global endeavor as approximately one half of all transplants involve a donor and patient in different countries. Accordingly, approaches to HCT quality and biovigilance need to be developed domestically and be congruent with and support international efforts. This session will look at efforts by NMDP to develop quality systems for marrow, PBSC and cord blood units and their international labelling and distribution. Protecting donor and patient safety are paramount in HCT, so robust biovigilance systems need to be in place to monitor a full range of quality-related incidents, including donor and patient adverse events, and to monitor product safety issues as well. This session will describe what we have learned about donor and patient adverse events and how we share these findings as international professionals so we can learn how to ensure and improve our safety efforts worldwide. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 62 (9331-QE) Ask the FDA & CMS/CLIA Director/Moderator: M. Allene Carr-Greer, MT(ASCP)SBB Moderator: Sharon Carayiannis, MT(ASCP)HP Speaker: Martin Ruta, JD, PhD; Salim Haddad, MD; Richard McBride, MS, MT(ASCP)SBB; Wendy Paul, MD; Peyton Hobson, PhD; Beth Rogerson, MT(ASCP)SBB; Safa Karandish, BS, MT(ASCP); Teresita Mercado, MS; Jaroslav Vostal, MD, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: Describe FDA blood and HCT/P policies, regulations and inspection programs. Describe Clinical Laboratory Improvement Amendments (CLIA) regulations that are applicable to blood and cellular therapy programs. Event Description: This event provides an opportunity for discussion of FDA and CMS/CLIA policies, regulations, guidance documents and inspection programs that are relevant to the oversight of blood and HCT/P programs. Questions for the discussion are submitted in advance via the AABB website. (030H) Scientific Oral Abstract Session: RBC Immunohematology: CD38 Interference with Serologic Testing and KEL Expression Effects (030I) Scientific Oral Abstract Session: Transfusion-Transmitted Infectious Diseases: Babesia, Chagas and Other Infectious Diseases (030J) Scientific Oral Abstract Session: Patient Blood Management (030K) Administrative Oral Abstract Session: Inventory Management, Storage and Distribution (030L) Administrative Oral Abstract Session: Quality Management (030M) Administrative Oral Abstract Session: Effective Continuing Education In Immunohematology: Response To Unmet Training Needs 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 63 TUESDAY, OCTOBER 25, 2016 8:30 a.m. - 10:00 a.m. (9401-S) Karl Landsteiner Memorial Award and Lectureship Director/Moderator: Jose Cancelas, MD, PhD Speaker: Stuart Orkin, MD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: The global impact of hemoglobin disorders and potential strategies for more effective management and/or cure. The relevance of the human fetal-to-adult hemoglobin switch for the hemoglobin disorders. New genetic approaches, genome-wide association studies (GWAS) and gene editing, and their power for understanding human disease biology. 4. Challenges and potential solutions, in bringing new knowledge and genetic tools to innovate therapy for patients. Challenges and potential solutions, in bringing new knowledge and genetic tools to innovate therapy for patients. Award Description: Initiated in 1954 to honor Karl Landsteiner, MD, whose lifetime research laid the foundation for modern blood transfusion therapy, this award recognizes a scientist whose original research resulted in an important contribution to the body of scientific knowledge. The scientist who receives the award shall have an international reputation in transfusion medicine or cellular therapies. The title of Dr. Orkins presentation is Solving the human fetal-to-adult hemoglobin switch. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 64 (9403-QE) Biorepositories 101: What You Need to Know About Establishing and Maintaining a High Quality Resource Director: Michele Sugrue, MS, MT(ASCP)SBB Moderator: Naynesh Kamani, MD Speaker: Adriana Brigatti, JD, MPH, LLM, CIP, CHRC; Jim Vaught, Ph.D.; Elizabeth Wagner, MPH Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate Objectives: Describe best practices in designing and maintaining a biorepository. Review federal regulatory and institutional requirements as they apply to the establishment of biorepositories. Discuss ethical and legal considerations in the collection and use of biorepository materials. Event Description: In a special issue of Time magazine in 2009, biobanking was featured as one of "10 ideas changing the world right now". Blood banks serve as the quintessential examples of biorepositories in that they are facilities for the collection, preservation, processing, storage and supply of biological material and associated data, which follows standardized operating procedures and supports clinical care and scientific investigation. Today, biorepositories are becoming important sources for cutting edge clinical care studies and research tools for studying disease and therapies. Biorepositories may include a wide range of contents from genomic specimens used in precision medicine to parathyroid tissue, corneal grafts, and bone material to name a few. Within this session, faculty will describe best practices to ensure high quality sample and data collection and storage. In addition, presenters will review the federal regulatory requirements applicable to biorepositories as defined by FDA, DHHS and HIPPA. Furthermore, ethical and legal issues affecting relationships between donors and patients or researchers including the concept of donation, proper informed consent, and protection of personal data will be discussed. (9405-LMT) The Evolving Role of the Medical Function in the 21st Century Blood Center — the Florida/OneBlood Experience Director: Rita Reik, MD Moderator: Richard Gammon, MD Speaker: Rita Reik, MD; Richard Gammon, MD; Tisha Foster, MD; Harold Alvarez, MD; Buff Mair, MD; Marsha Bertholf, MD 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 65 Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate to Advanced Objectives: Outline the process by which physician Medical Directors from four large independent community blood centers, adapted and contributed to a successful merger and integration, using a team approach coupled with measurable goals, policies and bylaws. Identify novel sources of revenue for the 21st century blood center that may result from transitioning away from a traditional "value-added services" approach to a billable fee-for-service model for the medical team. Describe how a large blood center merger creates a platform for scaled-up data collection that enhances intramural research, as well as collaborations with public health authorities and innovators in the blood banking world resulting in improved safety and efficacy of transfusions. Event Description: This session will explore the evolution of the blood center physician's role that resulted as legacy system Medical Directors adapted to a changing healthcare landscape of blood center mergers and shifting revenue streams. The discussion will include individual physician's perceptions, and experiences, and its scope will cover the areas of cellular therapies, therapeutic apheresis, centralized compatibility testing, blood wellness and anemia clinics, patient blood management models as well as traditional blood collection activities. In addition, there will be a discussion of the impact of merging several large donor databases on creating expanded research capabilities and opportunities. (9406-LMT) Coding and Reimbursement Director/Moderator: Theresa Wiegmann, JD Check back for faculty and a detailed description. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 66 8:30 a.m. - 12:00 p.m. (9402-TC) Modern Day Immunohematology: The Power of Serology with DNA Testing for Antibody Investigation Director: Christine Lomas-Francis, MSc, FIBMS Moderator: Mary Kowalski, MT(ASCP)SBB Speaker: Sandra Nance, MS, MT(ASCP)SBB; Craig Tauscher, MT(ASCP),SBB, MEd; E. Ann Steiner, MT(ASCP)SBB; Randall Velliquette; Sunitha Vege, MS; Anna Burgos; Hallie Lee Stroka, MT(ASCP)SBB ; Rebecca Bullock; Regina Leger, MSQA, MT(ASCP)SBB, CMQ/OE(ASQ) Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: Learn through group discussions how peers approach and solve antibody identification problems. Discover how the combined use of serology and DNA testing methods can be used to solve difficult cases and why results of serology and DNA testing might sometimes differ. Explain the use of enzymes or chemicals and advanced serological techniques as tools and discuss the importance of multiple methods for antibody identification. Event Description: Join peers for stimulating discussions and have fun solving immunohematology problem cases with colleagues from near and far! Using a round-table discussion format, this program will present basic to complex immunohematology case studies led by a moderator and round-table team leads. Utilizing small group discussions, participants will be given the opportunity to test their interpretive skills to solve cases and expand their immunohematology problem solving skills. Basic case studies incorporating routine serological methods with an introduction to DNA-based testing methods will start off the program with an evolution to complex cases incorporating more advanced serological techniques and DNA-based testing assays. (9404-QE) Teaching Problem Solving and Analytical Decision Making Skills Director: Karen Byrne, MDE, MT(ASCP)SBB Moderator: J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB Speaker: Marilyn Moulds, BA, MT(ASCP)SBB; Yeon Mi Kim; Kate Hernandez, MT(ASCP)SBB Intended Audience: Physicians, Technologists, Managers/Supervisors Teaching level: Basic to Intermediate Objectives: 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 67 Clarify definition of problem solving and analytical decision skills. Determine when skills are needed and who needs to have them. Outline a process to follow when problem solving and analytical decision skills are needed. Critique several cases that demonstrate outcomes of using problem solving and analytical decision making skills. Event Description: One expected skill of anyone in working in transfusion medicine is problem solving and analytical decision making. The individual should be capable to implement and delegate decisions regarding laboratory operation and exercise independent judgment in problem solving. This is a skill not only for those in training programs but for all who work in transfusion medicine. How does one teach this skill?? How does one demonstrate competency? This workshop will introduce a method to help develop this skill. Cases will be presented and a process will be discussed as to how to define the problem, generate alternatives, evaluate and select alternatives, implement solution, and determine its effectiveness. 10:30 a.m. - 12:00 p.m. (9407-S) Platelets, Hemostasis, Infection and Sepsis Director/Moderator: Olivier Garraud, MD, PhD Speaker: Olivier Garraud, MD, PhD; Matthew Rondina, MD Intended Audience: Physicians, Scientists, Technologists, Nurses, Perfusionists Teaching level: Intermediate to Advanced Objectives: To understand the role of platelets as sentinels of invading bacterial and viral pathogens, along to their function of sensors of vascular endothelium aJri*on. To demonstrate how platelet bacterial interactions, contribute to a prothrombotic milieu, and also to discuss the main consequences of (viral) infection on platelets and infection induced-thrombocytopenia. To review emerging data on platelets as immune effector cells during-more particularly--bacterial infection. Event Description: Although nucleate, platelets are key sentinels residing within the vascular space and mediate key aspects of surveillance, host defenses, and containment to invading bacterial (and viral) pathogens. Activation of platelets by infectious pathogens and toxins induces not only hemostastic responses bay also immune and inflammatory pathways. Dysregulated platelet activation during human infectious syndromes contributes either to pro-thrombotic outcomes, or to severe hemorrhagic syndromes. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 68 (9408-S-CT) What is the Blood Bank's Role in T-cell Immunotherapeutics? Director/Moderator: Philip Norris, MD Speaker: David McKenna, MD; Bruce Levine, PhD Intended Audience: Physicians, Scientists, Technologists, Nurses Teaching level: Intermediate to Advanced Objectives: Understand where the field of T cell therapy is and will be headed clinically and scientifically. Learn who is producing T cell therapeutics and why (economic, technical, and regulatory factors). Forecast where blood banks will contribute to T cell therapy. Event Description: T cell therapies are being scaled-up and translated to clinical treatment protocols at an accelerating pace. Potential indications for T cell-based treatment include chimeric antigen receptor (CAR) T cells or expanded tumorinfiltrating lymphocytes for cancer treatment, regulatory T cells for GVHD and other applications, and anti-viral T cells as prophylaxis or treatment after bone marrow transplant. How blood banks will be involved in producing the raw materials or finished products for each of these therapies is unclear. This session will explore how T cell-based therapies are currently prepared for clinical trials, as well as how the blood bank interfaces with industrial producers of T cell therapies. Issues such as technical hurdles in scale-up of production and regulatory requirements will be discussed. (9409-TC-PBM) Evidence-Based Medicine in the Perioperative Arena Director/Moderator: Mary Berg, MD Speaker: Mary Berg, MD; Camille van Buskirk, MD; Scott Brown, MS, CCP, LP Intended Audience: Physicians, Nurses, Managers/Supervisors, Perfusionists Teaching level: Basic to Intermediate Objectives: Discuss the risks and benefits of using cell salvage in cases of malignancy or infection. Describe the contents and potential uses of autologous platelet gel. Describe the contents and potential uses of autologous bone marrow aspirate. Event Description: New modalities in use in perioperative areas have few studies to support their use. Traditional cell salvage, which has been available for many years, still is not routinely used for obstetric cases or cases of malignancy or infection. This session will review published studies to discuss whether or not they support the use of bone marrow aspirate and platelet get. Similarly, studies regarding the use of cell salvage in controversial situations will also be reviewed. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 69 (9410-TC) Back to Basics: Do We Really Know it all When it Comes to Platelet Manufacturing and its Impact on Detection and Prevention of Bacterial Contamination of Blood Components Director/Moderator: Sandra Ramirez-Arcos, PhD, MSc Speaker: Anne Eder, MD, PhD; Sandra Ramirez-Arcos, PhD, MSc; Dirk De Korte, PhD Intended Audience: Physicians, Scientists, Technologists Teaching level: Basic to Intermediate Objectives: Describe how platelet manufacturing processes affect bacterial distribution into different blood components and their detection in the final products. Discuss the impact of bacteria growth dynamics and biofilm formation during platelet storage on bacterial detection methods and pathogen reduction technologies. Propose integrated, innovative activities to address the residual risk of transfusing bacterially-contaminated blood products. Event Description: Despite the implementation of several mitigation measures, blood product contamination with bacteria still constitutes the highest posttransfusion infectious risk. Current efforts are focused on changing sampling algorithms, improving screening methods or implementing pathogen reduction technologies. However, very few studies are focused on understanding how blood component collection, manufacturing, and storage influence bacteria growth and physiology and the potential clinical impact of these factors. Speakers in this session will review the current knowledge on platelet manufacturing and its impact on bacteria growth, detection and prevention in the final products, and stimulate a discussion on novel approaches to enhance blood product safety. (9411-TC) Comprehensive Perinatal Management Programs Director/Moderator: Debra Lane, MD, FRCPC Speaker: Debra Lane, MD, FRCPC; Gwen Clarke, BSc, MD Intended Audience: Physicians, Technologists, Nurses Teaching level: Intermediate Objectives: Review perinatal laboratory investigations. Describe the multi-provincial efforts in Canada to standardize perinatal laboratory investigations. Discuss the cost and benefits of implementing testing of maternal plasma for fetal DNA typing in managing pregnancies. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 70 Event Description: Over the last ten years, there have been many efforts to standardize laboratory policies and practices form the management of perinatal care in Canada. Recently the use of maternal plasma for fetal DNA testing has been added to the platform to provide enhanced perinatal care. The challenges of providing perinatal care where patients are distant from care will be discussed. The costs and benefits adding testing of maternal plasma for fetal DNA will be discussed. Comprehensive perinatal programs in Europe will be reviewed. (9412-QE) Training Programs as the Foundation to the Roadmap to Accreditation Director: Christine Bales, BS, MT(ASCP), I (ASCP), CQA(ASQ) Moderator: Diane De Coning, B Sc Speaker: Christine Bales, BS, MT(ASCP), I (ASCP), CQA(ASQ); Diane Coning, B Sc Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate to Advanced Objectives: The audience will learn the importance of developing multidiscipline training programs that support AfSBT/AABB accreditation. To demonstrate how training programs identify gaps that may not have been identified in an accreditation readiness baseline assessment. The audience will understand that a cohesive and planned training program is the foundation of the Roadmap to Accreditation. Event Description: The AABB International Technical Assistance (TA) Team introduces their approach to achieving Africa Society for Blood Transfusion (AfSBT) and AABB accreditation in TA supported countries in Sub-Saharan Africa through Quality and Technical/Operational training programs. These training programs are the foundation of the Roadmap to Accreditation and are based on adult learning principles. The TA team of experts in various disciplines (Donor Management, Laboratory, Quality Management and Operations) provide brief summaries of the training programs and the expected results achieved to support accreditation readiness. Training programs subjects include: Infrastructure (Sustainability), Clinical Interface, Quality Management Systems, Donor Recruitment, Blood Collection, Laboratory Practices (testing and component production), Information Technology, and Balanced Scorecard. After the discussion of the training programs, an update on the progress and accomplishments of the countries supported by AABB International Technical Assistance is presented and followed by a Q & A session. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 71 (9413-LMT) This Isn't Your Mother's Blood Bank Any More! New Collaborative Realities between Hospitals and Blood Suppliers: It's the People, Processes, and Products That Improve Patient Outcomes and Customer Service Director: Barbara Swanson, MEd, MT(ASCP), CQA(ASQ) Moderator: Houston "Buddy" Nguyen, BSCLS, MT(ASCP), BIT Speaker: Barbara Swanson, MEd, MT(ASCP), CQA(ASQ); Houston "Buddy" Nguyen, BSCLS, MT(ASCP), BIT; Allison Kelly, MLS(ASCP)SBB Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Understand how the blood supplier partnered with the hospitals and Transfusion Services for improving efficiencies in the Transfusion Service. Describe how implementing changes to long held Transfusion Service practices has allowed the Transfusion Service to significantly decrease red cell inventory, improve turn-around-time and decrease unnecessary crossmatching. Explain how a blood supplier can successfully assist in the implementation of a patient blood management program. Event Description: Description: The face of the 2016 blood bank from donor to patient continues to change with unparalleled speed. The blood supplier, the Transfusion Service and the hospital's medical and administrative teams are partnering to improve patient outcomes and customer service. In this program, the participant will hear from key constituents who will share their challenges and successes working to change old practices, implement new processes and assimilate new evidence-based recommendations and information about blood products (9414-LMT) Playing Nice in the Sandbox: How to Get Along with Others and How to Help Others Get Along with You Director: Judy Brazell, MA, MT(ASCP)SBB, CQA(ASQ), LPCI Moderator: Ruth Biehl, MS, MBA, MLS(ASCP)CM, CMQ/OE(ASQ), CQE(ASQ) Speaker: Judy Brazell, MA, MT(ASCP)SBB, CQA(ASQ), LPCI; Mark Bolte, PsyD Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Increase Self-awareness by understanding your needs and interpersonal style. Know your "conflict management style" and apply this to more effective conflict resolution. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 72 Develop strategies for dealing with "difficult" people and improve your interpersonal effectiveness. Event Description: The quality and effectiveness of one's working relationships are essential to job satisfaction, retention, and productivity. This interactive workshop will aid in how to better understand your interpersonal style and needs, and how to interact and influence others with greater effectiveness. Special focus will be on conflict management strategies, self-awareness as a leader, and dealing with "difficult" people. Join an expert in the industry and a clinical psychologist to explore the unique ways we can all work together more effectively. 2:00 p.m. - 3:30 p.m. (9415-TC) Blood Group Systems Update: Everything RH Director/Moderator: Greg Halverson, MT(ASCP)SBB, DLM Speaker: Connie Westhoff, PHD, SBB; France Pirenne, MD, PhD; Thierry Peyrard, PhD, PharmD, EurClinChem Intended Audience: Scientists, Technologists, Managers/Supervisors Teaching level: Intermediate to Advanced Objectives: To understand the latest changes and additions to the Rh Blood Group System. Learn how to manage D variant and D weak patients regarding the use of Rh D negative blood and Rh Immune Globulin. Be able to recognize Rh system variants and when there must be closer matching for patients that have variant antigens. Event Description: This session is meant to discuss new antigens and alleles in the Rh Blood Group System and learn how molecular genotyping has an important role in matching blood for chronically transfused patients such as those with Sickle cell disease and Thalassemia. Three speakers will address specific areas of RhD weak and RhD variants and the numerous variants in the RhCE allele. The primary focus will be to provide information regarding donor matches for patients with variant blood group antigens who are in danger of producing antibodies to high frequency antigens. (9416-TC-CT) Emergency INDs-How, When to Submit and What We Do and Do Not Learn from Treatment by Exception Director/Moderator: Jed Gorlin, M.D., M.B.A. Speaker: Victor Baum; Jed Gorlin, M.D., M.B.A.; Jerome L. Gottschall, MD; Richard Weiskopf, MD; Laura Cooling, MD, MS 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 73 Intended Audience: Physicians, Scientists, Technologists, Nurses, Perfusionists Teaching level: Intermediate to Advanced Objectives: Describe circumstances where use of novel unlicensed products may be required, including the treatment of Jehovahs Witness patients. Describe the FDA approval process for an emergency IND. Describe limitations to the therapeutic conclusions that can be drawn from uncontrolled usage of unlicensed products. Event Description: Several Presenters will share clinical cases of obtaining an e-IND (formerly compassionate use protocol). Cases involve use of hemoglobin based oxygen carriers for patients failing or refusing conventional transfusion therapy. The process for obtaining approval (both from manufacturer and the FDA) will be shared. While publications of such cases typically report only positive outcomes (publication bias), can we learn any lessons from case series. (9417-TC) Transfusion Thresholds and Ethics of Transfusion in the Beating Heart Organ Donor Population Director/Moderator: Emily Coberly, MD Speaker: Eric Gehrie, MD; David Chooljian, MD, JD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, Perfusionists Teaching level: Intermediate Objectives: Assess the latest evidence for transfusion thresholds, and determine how this evidence might apply to the beating heart organ donor population. Evaluate current transfusion practices in beating heart organ donors. Consider the ethical implications of transfusion in beating heart organ donors. Event Description: Beating heart organ donors (BHODs) are a common source of transplant organs in Western countries, but evidence regarding optimal transfusion practice in this population is currently lacking. In this session, we will review the current evidence for transfusion thresholds as it may apply to BHODs and will evaluate current transfusion practices in BHODs, including a focused discussion of the ethical implications of transfusion in this population. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 74 (9418-TC-PBM) Transfusion Practice: Management of the Obstetrical Patient Director/Moderator: Theresa Nester, MD Speaker: Kerry O'Brien, MD; Kathleen Puca, MD; Evelyn Lockhart, MD Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Describe the current recommendations for blood management in obstetric hemorrhage, emphasizing recent data. Review the current recommendations for the use of cell salvage during an obstetric hemorrhage. Discuss recent data on adjuvant pharmacotherapy use in obstetric hemorrhage, including fibrinogen concentrates and tranexamic acid. Event Description: Using case-based scenarios, session attendees will be polled to determine their current understanding of, and practice recommendations for, specific clinical scenarios involving the pregnant patient. The emphasis of the session will be to present updated recommendations and new findings since the AABB 2014 annual meeting. Topics will include the role of cell salvage and antifibrinolytics in obstetric hemorrhage. Data on laboratory predictors of severe post-partum hemorrhage and fibrinogen repletion during obstetric hemorrhage will also be reviewed. (9419-TC) Biosimilars and Biobetters - Focus on biosimilar G-CSF Director/Moderator: Halvard Bonig, MA, MD Speaker: Halvard Bonig, MA, MD; Henry Grabowski, Ph.D.; Arnon Nagler, MD Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Intermediate Objectives: Understand and apply the concept of "biological similarity" as applied to biosimilars. Identify risks and benefits of biosimilars - medical as well as economical. Make informed decisions about the evidence of (clinical) similarity of biosimilar G-CSF. Event Description: Session will explore how biosimilars are developed and approved, how similarity is demonstrated, what are the potential economical benefits of biosimilars, but also what are the risks and why the potential benefits might not play out. Finally, the cumulative evidence of clinical similary (or dissimilarity) of biosimilar G-CSF is explored. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 75 (9420-QE) Competency Assessment - Is it Fair? Director: Betsy Jett, MT(ASCP), CQA, CMQ/OE (ASQ) Moderator: Donna Strauss, MS Speaker: Sarai Paradiso; Kim Mielenz, BS,; Kathleen Crowley, MT(ASCP)SBB Intended Audience: Technologists, Nurses, Managers/Supervisors Teaching level: Intermediate Objectives: Outline the value and benefits of performing proper competency assessments of technical employees. Provide guidance on developing appropriate competency assessment tools. Discuss the challenges in performing an objective competency assessment on coworkers. Event Description: Performing Competency Assessment of Technical staff in the Blood Industry is not only a regulatory requirement but can be of great value when done properly. Technical staff in a Blood Center not only includes Medical Technologists, but also Collections and Manufacturing staff. Performing periodic competency assessments in a regulated environment can be challenging. Developing tools that are compliant with regulatory standards and robust enough to properly measure competency is not always as simple as it seems. Selecting responsible assessors and ensuring that they themselves are competent in both technical procedures and observational and interpersonal skills is also extremely important. Performing an objective, unbiased assessment of coworkers can be difficult for many staff. This session will describe the elements that should be included in competency assessment and identify the risks of performing a biased assessment. In the end, Competency Assessment is only as good as the tools and the assessor. (9421-QE-CT) Have You Counted Sources of Variability For Your Stem Cell Characterization Testing? Director: Ljiljana Vasovic, MD Moderator: Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ) Speaker: Vasiliki Kalodimou, PhD; Laura Connelly-Smith, MD; Michael Linenberger, MD; Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ) Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs Teaching level: Basic to Intermediate Objectives: Standardizing Post Thaw CTP Recovery, Viability and Potency. Reproducibility, Accuracy and Comparability of CTP Biological Assays. 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 76 Improving Your 95% Confidence Interval. Event Description: Laboratory test results guide for your patient Cellular Therapy Product (CTP) treatment strategies. Sampling strategy: When and where? Not all TNC, MNC, CD34, Viability, CFU tests are created equal. Preanalytical, analytical and post-analytical errors in CTP quality testing. How many assays do you need to be confident that reported result accurately describe your CTP? How do we measure Stem Cell Potency globally? (9422-LMT) Ethical Dilemmas in Transfusion Practices in Developing Countries Director/Moderator: Quentin Eichbaum, MD, PhD, MPH, MFA, MMHC, BSc(Med)(Hons), BA(Hons) Speaker: Silvano Wendel, MD,PhD; Hua Shan, MD, PhD; Ravi Reddy; Quentin Eichbaum, MD, PhD, MPH, MFA, MMHC, BSc(Med)(Hons), BA(Hons) Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists Teaching level: Intermediate to Advanced Objectives: To present an overview of global health ethics as it pertains to health care delivery related to transfusion practice in developing countries. To present cases of ethical dilemmas arising from transfusion practices in developing countries. To engage the audience in exploring solutions to these ethical dilemmas. Event Description: This session will first present an overview of global health ethics as it pertains to transfusion practices in developing countries. We will present specific CASES of ethical dilemmas in transfusion practices in various resource-constrained settings of developing countries. We will engage the audience in exploring solutions to these dilemmas, and highlight similarities and differences in practices between developed and developing countries. (040A) Scientific Oral Abstract Session: RBC Immunohematology: Studies of Alloimmunization Against RHD and Other Blood Groups (040B) Scientific Oral Abstract Session: Platelet and Leukocyte Biology (040C) Scientific Oral Abstract Session: Components and Component Processing II (040D) Scientific Oral Abstract Session: Donor and Therapeutic Apheresis 2016 AABB Annual Meeting Preliminary Program | www.aabb.org/annualmeeting | page 77