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American Society for Apheresis

NEWSLETTER

Summer 2010

IN THIS ISSUE ASFA News & Updates Education / Research Corner Ask an Apheresis Expert ASFA Committee Reports ASFA Membership *NEW* ASFA 2010 Photos ASFA Leadership Contact Us

FROM THE PRESIDENT'S DESK

I hope that those of you who at-

tended the ASFA annual meeting in New Orleans found the experience to be both educational and enjoyable. We had a very successful meeting and I have received very positive feedback from both the membership and our corporate sponsors. For those who attended, thank you! I hope to see all of you at the 2011 annual meeting at the Kierland Resort and Spa in Scottsdale next spring! As the newly elected president of ASFA, I will do my best to continue to move the Society forward. In keeping with the work started by my predecessor, we will continue to create and revise the policies that help govern our Society and ensure accountable and responsible governance. I would encourage all of the membership to take a look at the policies and the bylaws which are available on the Society's website. If anyone has any suggestions or questions, please contact the chair of the bylaws committee with regard to the bylaws and myself with regard to the policies that govern the Board of Directors. One of the other goals of my predecessor was to implement succession planning to ensure a seamless transition of leadership among the Society's committees as well as provide growth opportunities and greater opportunity for involvement among the membership. This year in selecting new committee chairs, I was able to take

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advantage of this for most committees and promote a qualified co-chair into the position of chair. For those of you who have an interest in a position of leadership in ASFA, I would encourage you to get involved on a committee. The Board of Director's hope is that involved committee members will become committee co-chairs, then committee chairs, and eventually members of the Board of Directors! There are a couple of committee changes that I would like to mention while I have the chance. First, the Residents and Fellows Training ad hoc committee has now become a standing committee called the Apheresis Physician Committee. This committee will continue to focus on the education of physicians about apheresis medicine, both those in training and in practice. The Out Reach ad hoc committee has merged with the Communications committee and will operate under that name. In addition to the responsibilities defined for the Communications committee by the bylaws, they are also seeking to increase communication with and recruitment of members from related medical societies and specialties which practice apheresis medicine, such as Nephrology. If you have an interest in serving as a member on either of these committees or any of the other committees listed on the Society's web site, I would encourage you to contact the committee's chair. By the time that you are reading this news letter, the fifth special of the Journal of Clinical Apheresis will have been published. With this newest edition, we hope to have made the special issue even more useful. This edition will provide even more detailed information about indications and includes not only the ASFA categories but also a recommendation grade to guide the practitioner as he or she considers treating a patient with apheresis. The special editions of the JCA have become recognized as critical apheresis resources throughout the world. Because of this, the Society, with financial sponsorship from an apheresis vendor, is planning to translate the fifth special edition into Spanish and Russian. Our hope is to further increase the international reputation of the Society and encourage evidence based apheresis medicine around the world. We anticipate that the sixth special edition, due to be published in 2013, will include authors from other countries to further broaden the scope of the apheresis treatments covered. Finally, another plan for the recently published fifth special edition is to provide a copy, as well as an explanatory cover letter, to every the insurance carrier in the United States. Our hope is to help them to better understand the role of apheresis in the treatment of disease and to correct misconceptions concerning the use of apheresis therapies. A number of insurance carriers have already approached the Society for input concerning their apheresis coverage documents and we will continue to provide such feedback in order to be an advocate for the patients that we treat. Thank you for the opportunity to serve you as the president of the American Society for Apheresis! I look forward to a productive year for our Society. Sincerely, Jeffrey L. Winters, M.D. President American Society for Apheresis

ASFA NEWS AND UPDATES

New ASFA Educational Materials

Journal of Clinical Apheresis - Special Issue (Volume 25, 2010)

Clinical Applications of Therapeutic Apheresis: An Evidence Based Approach. 5th Edition The highlight of the Fifth Special Issue is the redefinition of the Indication Categories and the adaption of the GRADE system for classifying the strength of the clinical recommendations based on the quality of the available published evidence. The decoupling of the Indication Categories from both the type and quality of evidence and from the strength of recommendations renders them of more practical value.Categories I and II now signify first-line or second-line therapy respectively, and nothing more. Category IV still signifies "not recommended" and, for the first time, the strength of that (non)recommendation and the quality of evidence that undergirds it are separately provided using GRADE system. The most noteworthy is the redefinition of Category III to signify not whether the evidence is conclusive or inconclusive, but rather to signify when the specific role of apheresis in a give clinical indication has not been definititively determined.

Principles of Apheresis Technology (4th Edition, 2010)

Technical Principles of Apheresis Medicine

This invaluable textbook, published by ASFA, provides a basic overview of the theory and applications of apheresis and can serve as a basis for developing training programs for those new to the field of apheresis. Topics covered include: · Basic Science · Apheresis Instrumentation · Clinical Application · Donor Apheresis · Apheresis Program Management Essentials · Therapeutic Apheresis Essentials · Regulatory Issues and Quality Activities · Apheresis Math and Useful Physical Constants

CD Recordings of ASFA 2010 Annual Meeting Scientific Sessions

Opening Combined and Closing Combined Symposia Recordings

The ASFA 2010 Annual Meeting Recording is a synchronized audio to PowerPoint Presentation and includes the following exceptional sessions that were held during the meeting: Opening Combined Symposium: Major Clinical Trials in Apheresis · Study Design and Evaluation of the Evidence by Jeff Carson, MD · STAR Trial by Joseph Kiss, MD · RING Trial by Thomas Price, MD · The Plasma Exchange for Vasculitis Trial (PEXIVAS) by Peter Merkel, MD, MPH · State of the Science (SOS) Trials by Zbigniew Szczepiorkowski, MD, PhD, FCAP Closing Combined Symposium: Therapeutic Apheresis · Challenges in Pediatric Apheresis by Jennifer Schneiderman, MD · TTP-like Syndromes of Atypical HUS by Nicholas Bandarenko, MD · Update on the JCA New Special Edition by Zbigniew Szczepiorkowski, MD, PhD, FCAP · Extracorporeal Photopheresis in Solid Organ Transplantation by Marisa Marques, MD

To order your copies of theASFA Educational Materials visit the ASFA webiste at www.apheresis.org/educational_materials!

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EDUCATION CORNER

Resources for New Providers of Therapeutic Apheresis Services

The applications and indications for Therapeutic Apheresis (TA) are immense, unique in the sense that the therapeutic benefits span multiple disciplines to include a variety of neoplastic, hematologic, neurologic, renal, rheumatologic and transplantation-related disorders. Regardless of the clinical setting, there are a multitude of resources available to new providers that have responsibility for oversight of apheresis procedures. The American Society for Apheresis (ASFA), perhaps the leader in information and resources for apheresis providers, has published many resources, many which are available on the internet. At the very least, a must have for new providers are the Guidelines for Therapeutic Apheresis Clinical Privileges1, Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians2, Guidelines on the Use of Therapeutic Apheresis in Clinical Practice3 and Therapeutic Apheresis: A Guide to Billing and Securing Appropriate Reimbursement.4 Examples of other resources available include the ASFA monthly teleconferences5, which serve as a way for clinicians to maintain their competency in the field of Therapeutic Apheresis whether there is daily direct oversight or occasional oversight of therapeutic apheresis procedures. Coming soon to the ASFA website will be patient information sheets which provide details on each of the various TA procedures for clinicians to share with their patients when obtaining informed consent for the procedure.6 Information sheets for providers which would provide a quick reference for treatment strategies for the most common disease states are forthcoming. Lastly, the latest edition of Principles of Apheresis Technology is an invaluable resource to training programs and those new to the field of apheresis, providing a basic overview of the theory and applications of apheresis.7 Informed consent for the apheresis procedure is generally the responsibility of the physician overseeing the procedure or designee and at a minimum should include information regarding the procedure to be performed and risks inherent to the procedure, including symptoms due to hypovolemia and citrate toxicity, infection and tenderness at the needle site, reactions and complications if blood components are used, hemolysis and red cell losses due to machine malfunction, thrombocytopenia due to platelet loss, risks specific to the underlying clinical condition, and risks associated with premature termination of the procedure for a variety of reasons.

For those centers where the blood bank has oversight of the therapeutic apheresis program and is inspected by the College of American Pathologists (CAP) as part of the Laboratory Accreditation Program, regulatory requirements for therapeutic and donor apheresis and therapeutic phlebotomy can be found in the Transfusion Medicine Checklist.8 Apheresis services that do not fall under the jurisdiction of Transfusion Medicine are not directly affected by the CAP checklist requirements, however the requirements are applicable in a broad sense should the therapeutic apheresis procedure become part of a tracer for hospitals accredited by the Joint Commission. Facilities involved in the collection of Peripheral Blood Stem Cells (PBSC) are subject to current good manufacturing practice regulations [cGMP; Code of Federal Regulations (CFR) Title 21 Parts 210 and 211], biological product regulations (21 CFR 610), and HCT/P regulations (21 CFR 1271), including current good tissue practice and donor eligibility requirements.9 Participation in the Foundation for the Accreditation of Cellular Therapy (FACT)10 and/or AABB11 accreditation programs can help to ensure compliance with the federal regulations. References

1. 2. Guidelines for Therapeutic Apheresis Clinical Privileges Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians Guidelines on the Use of Therapeutic Apheresis in Clinical Practice Therapeutic Apheresis: A Guide to Billing and Securing Appropriate Reimbursement. http://apheresis.org/asfa_webinars http://apheresis.org/disease_treatment Principles of Apheresis Technology, 4th Edition, 2010 www.cap.org Areman EM, Loper K. Cellular Therapy: Principles, Methods, and Regulations. AABB. 2009. http://www.factwebsite.org http://www.aabb.org

3. 4. 5. 6. 7. 8. 9. 10. 11.

Melanie Osby, MD Illeana Lopez-Plaza, MD ASFA Education Committee Members

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ASK AN APHERESIS EXPERT

How I Manage TTP

Thrombotic Thrombocytopenic Purpura carried an 80% mortality rate until the advent of plasma exchange and the survival reversed to 80% survival. However, the initial diagnosis, the course of management, and how to manage relapses or resistant disease remain challenging. The classic pentad of thrombocytopenica, microagiopathic hemolytic anemia, fever, renal insufficiency, and neurologic changes identifies only very late disease, and often the diagnosis is now made with only modest anemia and thrombocytopenia with the right index of suspicion. The classical cause is an inhibitor to the metalloproteinase ADAMTS-13 which cleaves high molecular weight von Willebrand Factor, causing increased platelet aggregation and Initial diagnostic testing includes a peripheral smear, LDH, a CBC, a sample for ADAMTS-13 assay later, and exclusion of other conditions such as DIC, hypertensive crisis, vasculitis, or sepsis.

Post-transplant TTP is less responsive or not responsive to plasma exchange, as are TTP syndromes with normal ADAMTS-13 levels. Craig Reeder, MD - Mayo Clinic Arizona Dennis Gastineau, MD - Mayo Clinic Rochester

ASFA COMMITTEE REPORTS ASFA Applications Committee Update

It's not too late to get excited about the application committee 2010-2011!!! The application committee's major charges include but not limited to: developing guidelines for therapeutic apheresis and appropriately modifying these guidelines with the rapidly evolving evidence; supporting the creation of standardized documentation for therapeutic apheresis; developing guidelines for donor apheresis; and promoting the involvement of ASFA in research activities related to apheresis as well as fostering collegial relationship with other societies involved in providing therapeutic apheresis services. Recent completed projects through the committee include the newly revised evidence based guidelines for therapeutic apheresis with the added grade system (2010 Special Review Issue of the Journal of Clinical Apheresis) and revised Clinical Privilege Guidelines for Therapeutic Apheresis Ongoing projects include analyzing the Performance Metrics Survey that was completed recently. Some new initiatives this year include developing rare disease registry for apheresis procedures, improving mobile apheresis service and improving and standardizing of pediatric apheresis. The work structure of the committee this year will be project based, and include creating working groups consist of a leader and 4-5 members for each project. The projects will be carried out through monthly conference calls with all the committee members in which the working groups will report progress, share opinions and seek feedbacks. New topics and projects may be added as they come up. At this time new ideas for projects are being welcome. The committee is open to all interested ASFA members. Joseph (Yossi) Schwartz, MD - Committee Chair Yan Yun Wu, MD, PhD - Committee Co-Chair

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ASFA Education Committee Update

The Education Committee has been busy working on educational resources for ASFA members. We have continued work with ongoing projects and have started a couple of new projects this year. The monthly webinars are scheduled through December, and we will soon begin work on the webinars for next year. If you are unable to attend the webinar you can purchase a CD of the presentation from the ASFA website. We were able to do an audio recording of the Opening and Closing Combined Symposiums at the Annual Meeting this year. We will have synchronized audio to Power Point presentations available for purchase on the website very soon. This is a new educational opportunity for members unable to go to the Annual Meeting. The Education Committee currently has 2 subcommittees. The Patient Resources subcommittee has been developing procedure specific fact sheets for patients and recently received a grant to continue development of patient related educational materials. These fact sheets will be available on the website in an area accessible to the public. We have formed a new Practitioner Resources subcommittee this year to develop disease and procedure related fact sheets for practitioners. Once developed these would also be available on the website as a therapeutic apheresis resource for practitioners. Also new this year is the quarterly newsletter. The Education Committee aids in the development of the newsletter. We determine topics and suggested authors for the Education and Research Corner, and Ask an Apheresis Expert sections. The editors of the newsletter are members of the Education Committee. The Editor-In-Chief is Dr. Torloni. Associate Editors are Dr. Miller and Dr. Hofmann. The newsletter is a resource for information to ASFA members as well as an additional educational tool. The Education Committee has been busy this year and hope that the projects we are working on are beneficial to the membership. Laura Collins RN, BSN, HP(ASCP) ­ Committee Chair Rubin Chandran, MD ­ Committee Co-Chair

ASFA MEMBERSHIP Top Ten Reasons to Join ASFA

1. ASFA is the premier voice for apheresis. 2. ASFA members receive this exclusive newsletter. Join a committee to have a voice in your organization. 3. Keep up to date with the most current information and discussions on apheresis medicine. 4. Access to the members-only section of the NEW and improved website. 5. Member only discounted registration fees for the annual meeting. 6. Network and learn from other professionals in the field of apheresis. 7. Obtain CEUs and educational opportunities via webinars and annual meeting. 8. Journal of Clinical Apheresis is the exclusive publication for apheresis medicine. 9. Attend the annual meetings and see the USA. 10. Renew by December 31 to guarantee you don't miss any of the member only benefits.

Visit www.apheresis.org/members to access membership benefits and learn more information

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31ST ANNUAL ASFA MEETING PHOTOS New Orleans 2010

AGM Award Ceremony

Zbigniew Szczepiorkowski, MD, PhD, FCAP 2009 - 2010 ASFA President

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ASFA LEADERSHIP Board of Directors

Officers

Jeffrey Winters, MD President Zbigniew Szczepiorkowski, MD, PhD, FCAP Immediate Past President Christopher Chun, MT(ASCP) President Elect Ravi Sarode, MD Vice President Nicholas Bandarenko, MD Treasurer Marisa Marques, MD Secretary

Directors

Debbie Ferrell,RN, HP(ASCP) Sheryl Kempin, RN, BSHA Sandra Sabin, RN, BSN, HP(ASCP) Bruce Sachais, MD, PhD Beth Shaz, MD Theresa Stec, BA, MT(ASCP) Robert Weinstein, MD

ASFA HEAD OFFICE 375 West 5th Avenue, Suite 201 Vancouver, BC , Canada V5Y 1J6

T. 604-484-2851 F. 604-874-4378 E. [email protected] www.apheresis.org

ASFA Newsletter

Editor-In-Chief

Sergio Torloni, MD

Associate Editors

Yvette Miller, MD Jan Hofmann, MD, MPH, MS

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