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Cellular Therapy Products Ñ Collection by Apheresis*
March 7, 2007
Program # 074568
Director: Zbigniew M. Szczepiorkowski, MD, PhD, Medical Director, Transfusion Medicine Service, Dartmouth-Hitchcock Medical Center
Faculty: Jeffrey Winters, MD, Director, Donor Services/Therapeutic Apheresis Unit, Mayo Clinic-Rochester; Zbigniew M. Szczepiorkowski, MD, PhD, Medical Director, Transfusion Medicine Service, Dartmouth-Hitchcock Medical Center
Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors
Objectives:
- Identify the most common variables in apheresis collection impacting the quality of the cellular therapy product.
- Understand the relationship between the characteristics of the apheresis product and patientsÕ outcome.
- Describe the current regulations and accreditation standards most relevant to apheresis centers collecting cellular therapy products.
- Learn the most common problems with labeling of cellular therapy components.
Event Description: This event will highlight the impact of the quality of HPC apheresis product on the recipientÕs outcome, and discuss the most common problems encountered during apheresis collection and their impact on the product characteristics. The session will also discuss examples of the current regulations and their impact on daily activities of apheresis centers collecting cellular therapy products. The most common regulatory problems will be discussed and examples of potential solutions will be presented.
Event Level: Intermediate to Advanced
*Cellular therapy-focused audioconference.
Content for this program was developed in cooperation with the American Society for Apheresis (ASFA).
Blood Conservation: Innovations, Challenges and Future Directions
March 14, 2007
Program # 074569
Director: Virginia Hughes, MS, MT(ASCP)SBB, CLS(NCA), Assistant Professor, Auburn University
Moderator: Timothy J. Hannon, MD, MBA, Medical Director, Blood Conservation Program, St. Vincent Hospital Indianapolis
Faculty: Nancy Chance, MLT(ASCP)RMT, Area Coordinator of Blood Bank and Bloodless Medicine and Surgery Coordinator, Riverview Hospital; Rochelle M. Strong, RN, BS, MA, CNOR, Director Surgical Services, Riverview Surgery Center
Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, Perfusionists
Objectives:
- Understand the necessity for blood conservation and its need for global attention.
- Learn the resources essential for launching a successful blood conservation program by forging a strong collaborative alliance between surgical services and blood banks.
- Identify barriers, challenges, and solutions during the process of establishing a successful blood conservation program.
- Quantify outcomes through appropriate reporting channels.
Event Description: This audioconference will provide an overview of blood conservation implementation and outcome assessment in a perioperative setting. First hand experience of ÒPlatelet GelÓ and its applications in blood conservation will be discussed.
Event Level: Intermediate
Donor Hemoglobin
March 28, 2007
Program # 074570
Director: Dennis Harpool, MT(ASCP)SBB, Vice President Procedures, Development, and Training, Blood Systems, Inc.
Faculty: Ritchard Cable, MD, Scientific Director, American Red Cross, Northeast Division; Alan Mast, MD, PhD, Investigator, Blood Research Institute and Associate Medical Director, Medical Services, Blood Center of Wisconsin
Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors
Objectives:
- Identify causes of donor deferral for low Hb/Hct and discuss appropriate communications to donors deferred for low Hb/Hct.
- Understand how blood donation impacts iron metabolism, iron stores and Hb/Hct levels.
- Comprehend ways to prevent deferral due to low Hb/Hct.
Event Description: This session will discuss appropriate communications to donors deferred for low Hb/Hct. In addition, the speakers will present biochemical, genetic and behavioral characteristics of donors able to donate at high frequency levels (five to six times per year) without being deferred due to low Hb/Hct.
Event Level: Intermediate
What To Do About Weak D
April 11, 2007
Program # 074571
Director/Moderator: Teresa Harris, MT(ASCP)SBB, CQIA(ASQ), Associate-Immunohematology Reference Lab-Operation Support, American Red Cross
Faculty: W. John Judd, FIBMS, MIBiol, Professor of Immunohematology, University of Michigan
Intended Audience: Physicians, Technologists, Managers/Supervisors
Objectives:
- Understand the fundamental differences between weak and partial D.
- Describe strategies to decrease RhD alloimmunization in partial D patients.
- Discuss the impact of transfusion strategies for partial D patients on the supply of Rh-negative blood.
Event Description: Weak D and partial D are not equivalentÑboth have different ramifications in patient and donor testing. This session will highlight the different protocols for weak D testing in the patient and donor populations. Current Rh typing reagents react differently with the partial and weak D phenotypes. Discussion will include strategies to prevent alloimmunization in the partial D patients and the impact of those strategies on the blood supply. Case studies will be presented to highlight the discussion.
Event Level: Intermediate to Advanced
Staff Competency
April 18, 2007
Program # 074572
Director: Kathleen M. Connolly, Director of Public Relations, Rhode Island Blood Center Moderator: Carol Perry, MT(ASCP), CQA(ASQ), Quality Assurance/ Compliance Officer, Rhode Island Blood Center
Faculty: Jill Drummond, Director, Training and Education, Blood Systems, Inc.; Judy Norcia, MT(ASCP)SBB, CQA(ASQ), Vice President of Quality Systems, Florida Blood Services, Inc.
Intended Audience: Technologists, Nurses, Managers/Supervisors, CEOs/CFOs
Objectives:
- Understand the resources needed for electronic management of training records.
- Describe the differences between competency and proficiency.
- List the steps to develop quality performance standards and competency assessment instruments.
Event Description: This session will define competency and proficiency, and will review regulatory requirements for training. In addition, it will describe the difference between skill- based and knowledge-based tasks and the most effective type of competency assessment for each.
Event Level: Intermediate
Validating Software to Ensure Patient Safety
May 9, 2007
Program # 074574
Director: Cynthia White, MHA, SBB(ASCP) MT(AMT), Implementation Consultant, Mediware Information Systems
Faculty: Marsha Senter, ASCP, CQA(ASQ), Director,RA/QA, Mediware Information Systems
Intended Audience: Technologists, Managers/Supervisors, CEOs/CFOs
Objectives:
- Understand the expectations of regulating agencies as they relate to the processes that support the implementation, modification and maintenance of computer systems.
- Comprehend the expectations of documentation practices of support of computerized systems.
- Learn processes that ensure continuous operation of the services and prevent unauthorized access to computers and electronic records.
Event Description: The scope of computer systems is defined to include hardware, software, peripheral devices, personnel and documentation. Regulatory agencies recommend a practice of Òrisk-basedÓ validation processes for ensuring the safety of electronically stored data. Regulatory and accrediting agencies have established standards and guidelines that relate to the process of implementing, modifying, and maintaining these systems and electronically stored data. This seminar will review some of the aspects of these recommendations and standards. The review will discuss processes of creating a validation plan for software validation and the expected outcomes of validating systems. Included in the discussion will be topics of the assurance of personnel competency and prevention of unauthorized access to computers and electronic records.
Event Level: Intermediate to Advanced
Management of Acute Transfusion Reactions
May 16, 2007
Program # 074575
Director/Moderator: Jennifer Rhamy, MBA, MA, MT(ASCP)SBB, HP, Vice President, Laboratory Services, Indiana Blood Center
Faculty: Susan T. Johnson, MT(ASCP)SBB, Manager, Immunohematology Services, Blood Center of Wisconsin; Lynne Uhl, MD, Medical Director, Transfusion Medicine, Beth Israel Deaconess Medical Center
Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, Perfusionists
Objectives:
- List the laboratory tests that are useful in making a diagnosis of a transfusion reaction and identify the standard treatment protocols for managing transfusion reactions.
- Using the flowchart developed by AABBÕs SSCC, outline the process for investigating transfusion reactions.
- Name the required elements of a transfusion reaction investigation as defined by the governing/ accrediting agencies.
Event Description: This audioconference focuses on the management of acute adverse reactions to transfusion. The session will discuss following a flowchart protocol similar to the one found in the guidelines produced by AABBÕs Scientific Section Coordinating Committee (SSCC). Emphasis will be placed on regulatory requirements for investigation of these reactions. In addition, the program will focus on the patient and clinical considerations when managing these adverse events.
Event Level: Intermediate
ABO and Crossmatch-Incompatible Renal Transplantation: Why, How and the Role of Apheresis
June 13, 2007
Program # 074577
Director: Jeffrey Winters, MD, Director Donor Services/Therapeutic Apheresis Unit, Mayo Clinic-Rochester
Faculty: James Gloor, MD, Associate Professor of Medicine and Pediatrics, Division of Nephrology, Mayo Clinic; S. Breanndan Moore, MD, FRCPI, Consultant, Division of Transfusion Medicine, Mayo Clinic Rochester; Jeffrey Winters, MD, Director Donor Services/Therapeutic Apheresis Unit, Mayo Clinic-Rochester
Intended Audience: Physicians, Scientists, Nurses
Objectives:
- Understand the rationale behind ABO and cross match incompatible renal transplantation and also the importance of patient selection in a successful ABO or cross match incompatible renal transplant.
- Learn the importance of ABO and HLA antibody titers in determining the time of transplantation and in guiding post-transplant therapy.
- Review testing methods used to determine the time of transplantation and to monitor patients after transplantation.
Event Description: Due to limitations in available organs and an inability to find HLA matched organs for patients highly sensitized to HLA, institutions have implemented living donor renal transplant programs involving ABO or cross match incompatible donors. These programs seek to provide the opportunity for transplantation to patients who are essentially ÒuntransplantableÓ (patients highly alloimmunized to HLA) or who would wait for extended periods of time on organ waiting lists (blood group B or O candidates), experiencing the increased morbidity/mortality associated with dialysis. In order for these transplants to be successful, antibody titers are reduced prior to transplantation and in the immediate transplant period through a combination of immunosuppression, intravenous immunoglobulin, and plasma exchange. This presentation by three speakers involved in such a program will review the importance of patient selection and preparation, patient/donor testing, and plasma exchange in successful transplantation of incompatible kidneys. Protocols used by other institutions will also be discussed.
Event Level: Intermediate to Advanced
Issues in Platelet Transfusions
June 20, 2007
Program # 074578
Director/Moderator: Jennifer Rhamy, MBA, MA, MT(ASCP)SBB, HP, Vice President, Laboratory Services, Indiana Blood Center
Faculty: James P. AuBuchon, MD, FCAP, FRCP(Edin), Professor and Chair of Pathology, Dartmouth-Hitchcock Medical Center; Jay Herman, MD, Transfusion Medicine Director, Thomas Jefferson University
Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors
Objectives:
- Describe the survival and quality characteristics of 7-day platelets.
- Identify the current technologies associated with bacterial detection and their performance criteria.
- List pros and cons of providing ABO-compatible platelet products.
- Name factors that are important in choosing platelet products for individual patients.
Event Description: Are all platelets created equal for all patients? This program will determine how the new technologies are changing the platelets in the bag. The speakers will discuss considerations for selecting plateletsÑrandom versus apheresis, ABO compatibility and other topical issues.
Event Level: Intermediate
Update on Sickle Cell Disease Treatment
July 11, 2007
Program # 074580
Director: Jennifer Rhamy, MBA, MA, MT(ASCP)SBB, HP, Vice President, Laboratory Services, Indiana Blood Center
Moderator: Paul Mintz, MD, Professor of Pathology/Internal Medicine, Director, Clinical Laboratories & Blood Bank, University of Virginia Medical Center
Faculty: Scott Miller, MD, Professor of Clinical Pediatrics and Director of the Inpatient Pediatric Services, SUNY Downstate Medical Center; Araba Afenyi-Annan, MD, MPH, Assistant Professor, Transfusion Medicine Service, University of North Carolina Hospitals
Intended Audience: Physicians, Technologists, Nurses, Managers/Supervisors, Perfusionists
Objectives:
- Identify the current treatments used for sickle cell patients to treat their disease including the use of hydroxyurea to limit transfusions.
- Describe the outcome of the STOP trials using trans-cranial Doppler and chronic transfusions to limit strokes in pediatric patients.
- Explain the benefits of phenotyping blood for sickle cell patients.
- Understand the benefits and considerations for RBC exchange versus transfusion therapy or alternate treatments for sickle cell patients.
Event Description: This audio conference focuses on todayÕs management of sickle cell patients. A clinician will discuss how these patients can be successfully managed by therapies in conjunction with transfusion, while another speaker will discuss options in selecting blood for these patients. The role of red cell exchange and antigen matching will both be reviewed.
Event Level: Intermediate to Advanced
Preparing for an Inspection in the Unannounced Era: CAP, FDA Internal QA, AABB, JCAHO
July 18, 2007
Program # 074581
Director: Denise M. Harmening, PhD, MT(ASCP), CLS(NCA), Professor, University of Maryland School of Medicine
Faculty: Sharon Novak, MA MT(ASCP)SBB, Laboratory Administrator, Georgetown University Hospital; Teresita Schultz, Transfusion Medicine Manager, Robert Wood Johnson University Hospital and Technical Director, New Brunswick Affiliated Hospitals Blood Center; Mary Beth Bassett, BS, MT(ASCP), Vice President Quality Management/Regulatory Affairs, Blood Systems, Inc.
Intended Audience: Technologists, Managers/Supervisors
Objectives:
- Understand the various aspects of the preparation process in order to ensure that each staff member takes ownership and responsibility for assigned tasks.
- Present and use effective tools such as an internal ÒSelf Assessment Outcome AnalysisÓ to identify areas that require improvement.
- Comprehend the unannounced assessment/inspection as a means to validate the effectiveness of the quality management system and operational processes in place as well as the opportunity for improvement where applicable.
- Describe the approach to the inspection and the inspection process.
Event Description: This audioconference will enable participants to prepare for and successfully manage unannounced inspections and eliminate the need to panic when the inspectors arrive. A brief overview of key points to enable blood bank participants to prepare for a stress free unannounced assessment/inspection will be discussed. Experiences from AABB/CAP, JCAHO and FDA unannounced inspections will be presented.
Event Level: Intermediate
Red Cell Antigens: Molecular Structure, Function and Disease Association
July 25, 2007
Program # 074582
Director/Moderator: Teresa Harris, MT(ASCP)SBB, CQIA(ASQ), Associate-Immunohematology Reference Lab-Operation Support, American Red Cross
Faculty: Connie Westhoff, PhD, MT(ASCP)SBB, Scientific Director, American Red Cross
Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors
Objectives:
- Identify the molecular structures associated with red cell antigens.
- Describe the association of red cell antigens and disease.
- Understand the functions of red cell antigens and their associated structure.
Event Description: Red cell antigens are located on structures that are an integral part of the red cell membrane. The structures, with their associated antigens, provide vital functions such as receptors, activators and transporters. This audioconference will explore the multiple aspects of red cell antigens and the associated membrane structures.
Event Level: Intermediate to Advanced
Supplier Qualifications: Equipment-Reagents and Vendors
August 29, 2007
Program # 074585
Director: Sally Rudmann, PhD, MT(ASCP)SBB, Professor and Director, The Ohio State University Medical Center
Faculty: Suzanne Butch, MA, MT(ASCP)SBB, CQA(ASQ), Administrative Manager, University of Michigan Hospitals; Mary A. Lieb, BS, MT(ASCP)SBB, CQA(ASQ), Quality Consultant, Quality Source
Intended Audience: Technologists, Managers/Supervisors, CEOs/CFOs
Objectives:
- List the requirements for vendor qualification.
- Develop forms for documenting the vendor qualification process.
- Select a vendor qualification process suitable for reagents, supplies and product manufacturing.
Event Description: Implementing a policy for qualification of vendors has been a difficult task. When is a site visit appropriate? What kind and how much documentation is needed? How often should it be repeated? Using a case study approach, the speakers will provide answers to these questions as well as tips for effective and efficient vendor qualification. Attendees will have an opportunity to ask questions following the formal presentation.
Event Level: Intermediate
Best Practices for Clinical Trials
September 26, 2007
Program # 074587
Director: Jerry Holmberg, PhD, MT(ASCP)SBB, Senior Advisor for Blood Policy and Executive Secretary, Department of Health & Human Services
Moderator: James P. AuBuchon, MD, FCAP, FRCP (Edin), Professor and Chair of Pathology, Dartmouth-Htichcock Medical Center
Faculty: Nancy Heddle, MSc, ART, FCSMLS(D), Director, McMaster Transfusion Research Program, McMaster University; Larry J. Dumont, MBA, PhD, Scientist, Dartmouth-Hitchcock Medical Center
Intended Audience: Physicians, Scientists
Objectives:
- Understand the importance of a well planned clinical study.
- Comprehend the ramifications of different clinical trial structures.
- Learn the basis of the statistical analysis that flow from decisions about clinical trial structures.
Event Description: Designing a clinical study requires more than asking a question and collecting data. This audioconference will discuss the importance of designing the best study for addressing clinical question(s) and possible ramifications of a poorly designed study. It will address the importance of statistical design in structuring of the power of the study. Valid data, statistical analysis and conclusions about the findings will be discussed.
Event Level: Intermediate to Advanced
Donor Dilemmas and Management of Nonconforming Cellular Therapy Products*
October 3, 2007
Program # 074588
Director/Moderator: Jay H. Herman, MD, Transfusion Medicine Director, Thomas Jefferson University
Faculty: Elizabeth J. Read, MD, Chief Cell Processing Section, National Institutes of Health; Donna M. Regan, MT(ASCP)SBB, Manager, St. Louis Cord Blood Bank, SSM Cardinal Glennon ChildrenÕs Medical Center; Brenda Alder, MS, MT(ASCP)SBB, Quality Assurance and Standards Coordinator, Northside Hospital
Intended Audience: Physicians, Technologists, Managers/Supervisors
Objectives:
- Describe the Donor History Questionnaire for Allogeneic HPC-A and HPC-M donors as a tool for donor screening.
- Discuss the donor qualification approaches used by cord blood banks to assure quality and safety of products.
- Define the differences between exceptions to donor eligibility criteria and HCT/P deviations in donor screening and testing, and how they should be documented, managed and reported to the FDA.
Event Description: Arguably, determining donor eligibility can be one of the most challenging steps in establishing product quality and suitability. The lack of uniform HPC product specifications and unique donor/patient relationship make the application of standard algorithms designed for transfusion services difficult to apply. This audioconference will address the screening and qualification of donors and provide details and guidance on the use of the donor history questionnaire for allogeneic PBSC and bone marrow donors. The unique challenges of screening UCB donors will also be discussed, focusing on successful approaches that increase consumer confidence and the challenges that complicate the ability to enhance the ethnic diversity in a cord blood bank inventory. Finally, a review of what constitutes an exception to FDAÕs donor eligibility criteria, as opposed to a reportable HCT/P deviation, and how to manage them will be presented.
Event Level: Intermediate to Advanced
Laboratory Employee Recruitment and Retention
October 17, 2007
Program # 074589
Director/Moderator: Lynn A. Emmert, MEd, MT(ASCP)SI, CLS(NCA), Technical Education & Quality Support Supervisor, Puget Sound Blood Center
Faculty: Elaine Osier Hathaway, MT(ASCP)SBB, Laboratory Quality Assessment Manager, Alaska Native Medical Center; Eva D. Quinley, MS, MT(ASCP)SBB, CQA(ASQ), VP of Quality Systems and Compliance, American Red Cross
Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs, Perfusionists
Objectives:
- Describe new recruitment strategies for hiring new graduates and experienced clinical laboratory scientists.
- Develop retention packages to present to administrators and financial officers.
- Construct a career ladder for career development progression.
- Learn the steps to enhance employee job satisfaction and create employee appreciation programs to perpetuate employment longevity.
Event Description: The shortage of the workforce in transfusion medicine and laboratory medicine reflects negatively on our profession. Critical elements in acquiring and maintaining sufficient personnel must be improved to ensure continued existence of the profession and to assure patient safety. These elements include recruitment techniques, retention packages and career development for laboratory personnel, both in transfusion medicine and in clinical laboratories.
Event Level: Basic
Lean Supply Chain Management
November 14, 2007
Program # 074591
Director/Moderator: Susan Steiner, MBGM,MT(ASCP)SBB, Manager, Americas Market Development and Field Training, Gambro BCT, Inc.
Faculty: Michelle Stefan, MT(ASCP), CQA(ASQ), Senior Director of Administration, Carter Blood Center; Bobbi Jewett-Keefe, MT, CLS(NCA), RT(CSMLS), Implementation Consultant, Gambro BCT
Intended Audience: Technologists, Managers/Supervisors, CEOs/CFOs
Objectives:
- Learn the basic principles of ÒLeanÓ and discuss the application of ÒLean PrinciplesÓ to a blood centerÕs supply chain management.
- Identify the critical success factors in applying the principles of ÒLeanÓ to your blood centerÕs process.
- Discuss the positive impact of applying ÒLean PrinciplesÓ to your supply management, such as elimination of excess storage and the benefits of appropriate forecasting.
Event Description: This program provides an overview of ÒLean PrinciplesÓ and itÕs application to the blood centerÕs supply chain management. A look at the critical success factors in applying these principles as well as the positive impacts this can have on a blood centerÕs operation will be discussed.
Event Level: Intermediate to Advanced
Problem Solving Gel, Solid Phase
December 5, 2007
Program # 074593
Director/Moderator: Denise M. Harmening, PhD, MT(ASCP), CLS(NCA), Professor, University of Maryland School of Medicine
Faculty: Susan T. Johnson, MSTM, MT(ASCP)SBB, Manager, Immunohematology Services, Blood Center of Wisconsin
Intended Audience: Physicians, Scientists, Technologists, Managers/Supervisors
Objectives:
- Describe similarities and characteristics unique to tube testing, gel testing and solid phase in detecting antibodies.
- Define a logical approach to identify antibodies regardless of the method used to detect the antibody.
- List situations when traditional tube testing may be necessary in antibody identification.
Event Description: This program will review characteristics of tube testing, column agglutination (gel) technology and solid phase tests, focusing on similarities and important differences in detecting antibodies. Advantages and limitations will be discussed for all three methodologies. A logical approach to problem-solving will be presented and will apply regardless of the technique used.
Event Level: Intermediate |
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