President’s Letter
Happy New Year! As we all work to stick to our New Year’s resolutions, the FACT Board of Directors is planning to set its goals at its retreat in April of this year. In addition to refining the new initiatives we launched within the past year, we have great momentum to continue making a difference in new and exciting ways. As we plan our retreat, please feel free to offer suggestions about objectives we should consider over the next three years.
As we set new goals, we also need to keep focus on maintaining the foundation we have built as an accrediting organization. One of the most important roles in our program is that of the inspector. As the number of FACT-accredited programs increases, our needs for inspectors increase. If you are already an inspector, please make a New Year’s resolution to perform at least two inspections in 2017. If you are interested in becoming a new inspector, we want to hear from you. Apply online at www.factwebsite.org.
Last, but definitely not least, I am pleased to announce that the FACT Standards for Immune Effector Cells has been published, along with immune effector cell-related interim standards as part of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. We are excited to learn new things from immune effector cell programs and help make this therapy a high-quality option for more patients.
I wish you a happy, healthy, and joyous new year.
Sincerely,
Dennis Gastineau, MD
Now Available – Interim FACT-JACIE Standards for Immune Effector Cells
Through the work of the Immune Effector Cell Task Force, led by Co-Chairs Dr. Helen Heslop, Dr. EJ Shpall, and Dr. Michael Lill, FACT has published interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration. The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others. The requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.
These requirements will become effective on March 1, 2017. All FACT-accredited cellular therapy programs that administer immune effector cells must be in compliance with the new standards by this date. If you have any questions, contact the FACT office at fact@unmc.edu.
The updated Standards, accompanying Accreditation Manual, and summary of changes are available on the FACT website for reference. Printed copies of the Standards and Accreditation Manual may be purchased from the FACT store.
FACT-JACIE Hematopoietic Cell Therapy Standards
Cellular Therapy Accreditation Manual
Changes to 6th Edition FACT-JACIE Standards
FACT Publishes First Edition of Immune Effector Cell Standards
The first edition of the FACT Standards for Immune Effector Cells has been published. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
Transplant programs that also administer immune effector cell programs should refer to the FACT-JACIE Hematopoietic Cell Therapy Standards for a complete set of requirements pertaining to both HPC transplant and immune effector cells. (Compliance with the immune effector cell standards by March 1, 2017 is required of FACT-accredited programs performing this type of therapy.) Stand-alone immune effector cell therapy programs should reference the FACT Immune Effector Cell Standards. Applications for accreditation of these programs will be accepted in February. More details will be forthcoming. In the meantime, a self-assessment tool is available to help stand-alone programs prepare.
The scope of the Standards includes donor selection and management, administration of cells, management of adverse events, and evaluation of clinical outcomes. The Standards require a quality management (QM) program that establishes, maintains, monitors, and implements improvements in the quality of facilities, processes, and performance.
These Standards were prepared under the assumption that some programs will be responsible for collection and processing of immune effector cells. Regardless of where the product comes from, the program must meet clearly defined responsibilities for chain of custody, storage, verification of product identity, and management of adverse events. In so far as a program is responsible for collection of cells, manufacturing of the cellular therapy product, or preparing the product for administration, the collection and processing requirements in the FACT Immune Effector Cell Standards apply.
FACT Standards for Immune Effector Cells
Immune Effector Cell Accreditation Manual
FACT Achieves Major Accomplishments in 2016
The 20th year of FACT successfully built upon its history of successes to advance cellular therapy and regenerative medicine. As physicians and scientists continue to make advancements, opportunities arise for FACT to play a supporting role to educate all programs on new approaches and therapies. The following are highlights from 2016:
1. FACT Celebrates 20th Anniversary
FACT celebrated its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. FACT welcomed visitors to a dynamic exhibit booth at the BMT Tandem Meetings and the ISCT Annual Meeting to celebrate with the organization. Attendees who wore their commemorative FACT 20th anniversary pin received gifts and were entered in a daily drawing for prizes.
FACT also hosted anniversary receptions at these meetings, and many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and refreshments as FACT celebrated two decades of working together in the community to improve patient care and safety. Guests enjoyed watching a short video highlighting FACT’s past 20 years, and saw some familiar faces who have been an integral part of FACT since its beginning.
2. FACT Commences Review of Corrective Action Plans for Low One-Year Survival
The FACT Clinical Outcomes Improvement Committee began formally reviewing corrective action plans submitted by Clinical Programs that did not meet expected one-year survival as outlined by comparative data. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients. After several months of reviewing corrective action plans, the committee has articulated its expectations for these plans using six guidelines:
- The corrective action plan must identify specific causes of death.
- The corrective action plan must provide quantitative data.
- The assessment must identify reasonable causes of the low one-year survival rate.
- The corrective action plan must address the identified causes.
- There must be a measurable outcome improvement.
- The program must provide updates on corrective actions at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee.
3. FACT Presents Comments at FDA Hearing
The Food and Drug Administration (FDA) hearing to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) occurred on September 12-13, 2016. Dr. Phyllis Warkentin spoke on behalf of FACT and presented the following comments to the FDA:
- FDA should fulfill its responsibilities to protect patients in search of cellular therapies. FACT supports its parent society, the International Society for Cellular Therapy (ISCT), in its position on unproven therapies and agrees on the importance of providing adequate education for patients. Development of professional standards and voluntary accreditation can play an important role in providing a bridge from basic research to clinical application.
- The tiered unified approach to HCT/P regulation fails to acknowledge the complexity of some tissues with multiple native functions and many cell types. It is difficult to strictly categorize complex tissues such as adipose tissue as only structural or cellular. Dr. Warkentin offered solutions for applying regulations to such tissues.
- There appear to be some inconsistencies in the definitions and examples of homologous use that would benefit from clarification.
- FACT suggests that the Agency expand upon its expectation for cord tissue, to include which regulations apply and when they apply, based upon the processes in place.
- International harmonization is important to facilitate product development and world-wide availability of cell-based therapies for patients.
4. Sixth Edition NetCord-FACT Cord Blood Standards Published
NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and its accompanying Accreditation Manual on July 1, 2016. These Standards became effective after 90 days, and all accredited cord blood banks were required to comply with the requirements by that time.
These Standards cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage, including quarantine, testing, and characterization of the cord blood unit; 4) making the cord blood unit available for administration, either directly or through listing with a search registry; 5) the search process for selection of specific cord blood units; 6) reservation and release of cord blood units for clinical use; and 7) all transport or shipment of cord blood units, whether fresh or cryopreserved.
5. Draft 1st Edition Immune Effector Cell Standards Published for Public Comment
FACT published a draft of the 1st edition FACT Standards for Immune Effector Cells for inspection and public comment in July 2016. Interim standards for the 6th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration were also proposed to include immune effector cell programs within blood and marrow transplant units. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field.
The Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
Commenters included, among others, pharmaceutical companies, the FDA, the American Society of Cell & Gene Therapy (ASGCT), and the Society for Immunotherapy of Cancer (SITC). A total of 131 comments were received, and reviewers generally expressed support for the Standards and posed worthy questions to consider.
6. CYCORD is First Cord Blood Bank in Cyprus to Earn FACT Accreditation
CYCORD Public Allogeneic Cord Blood Bank in Cyprus received internationally recognized FACT accreditation. CYCORD, directed by Paul Costeas, PhD, is the first and only cord blood bank in Cyprus to be recognized by FACT. The bank received accreditation on June 13, 2016, and is accredited for banking cord blood for both public and private family use.
7. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario is First Cellular Therapy Program in Mexico to Earn FACT Accreditation
Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario in Mexico received internationally recognized FACT accreditation. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario, directed by David Gomez-Almaguer, MD, is the first and only cellular therapy program in Mexico to be recognized by FACT. The program received accreditation on September 6, 2016, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.
8. StemCyte India Therapeutics is First Cord Blood Bank in India to Earn FACT Accreditation
StemCyte India Therapeutics Cord Blood Bank, directed by Bhavin Kapadiya, MD, is the first and only cord blood bank in India to be recognized by FACT. The bank received accreditation on December 21, 2016, and is accredited for banking cord blood for both public and private family use.
9. FACT Hosts Quality Initiatives with Parent Organizations
FACT hosted a Quality Boot Camp at the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The goal of the boot camp program is to strengthen quality assurance activities through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee encouraged registrants in the months leading to the in-person workshop to review specific aspects of their quality programs. Quality experts then presented important concepts and led roundtables that allowed participants to ask questions and help each other reach their goals during the boot camp. FACT also partnered with ISCT at their regional meeting to co-host sessions in the Quality and Operations Track. Presentations focused on outcome analysis from the processing perspective and the anatomy of an audit.
10. New Webinar Collaboration Between ASHI and FACT
FACT and the American Society for Histocompatibility (ASHI) began collaborating to offer webinars on transplant immunology. Establishing best practices in transplant immunology in different parts of the world requires both deep understanding of the unique challenges that face different parts of the world, and building on the experiences of well-established labs and international histocompatibility professional societies.
11. FACT Joins Standards Coordinating Body as a Charter Member
The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts. More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).
FACT Board of Directors Welcomes New Member and Nominates New Officers
The FACT Board of Directors approved its updated appointments in December, which became effective January 1, 2017. We thank these volunteers for their time and dedication to direct the activities of FACT. We are confident in their ability to continue leading FACT as a peer-driven organization that is adaptable to the needs of its constituents.
New officer appointments include:
- Vice President: Ngaire Elwood, PhD
- Secretary: Carlos Bachier, MD
Board members consist of representatives of FACT’s parent organizations, The American Society for Blood and Marrow Transplantation (ASBMT) and the International Society for Cellular Therapy (ISCT). ASBMT reappointed Mark Litzow, MD and Kimberly Kasow, DO to the Board, and ISCT reappointed Ngaire Elwood, PhD. ISCT appointed Abba Zubair, MD, as its new representative. The Board also approved expanding its composition to include a seat for a member appointed by the American Society of Apheresis (ASFA), and the nomination process is underway.
The following is a complete list of the FACT Board of Directors:
- President: Dennis Gastineau, MD; Mayo Clinic Rochester Blood and Marrow Transplant Program; Rochester, Minnesota, USA
- Vice President: Ngaire Elwood, PhD; BMDI Cord Blood Bank; Parkville, Victoria, Australia
- Past President: Helen Heslop, MD; Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital; Houston, Texas, USA
- Secretary: Carlos Bachier, MD; Sarah Cannon Blood and Marrow Transplant Program; Nashville, Tennessee, USA
- Treasurer: Michael Lill, MD; Blood and Marrow Transplant Program at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; Los Angeles, California, USA
- Chief Medical Officer: Phyllis Warkentin, MD; Biologics Production Facility, Nebraska Medicine; Omaha, Nebraska, USA
- Catherine Bollard, MBChB, MD, FRACP, FRCPA; Children’s National Health System Blood and Marrow Transplant Program; Washington, District of Columbia, USA
- Paul Eldridge, PhD; UNC Bone Marrow Transplant and Cellular Therapy Program; Chapel Hill, North Carolina, USA
- Hugo Fernandez, MD; H. Lee Moffitt Cancer Center & Research Institute Blood and Marrow Transplant Program; Tampa, Florida, USA
- Kimberly Kasow, DO; UNC Bone Marrow Transplant and Cellular Therapy Program; Chapel Hill, North Carolina, USA
- Mark Litzow, MD; Mayo Clinic Rochester Blood and Marrow Transplant Program; Rochester, Minnesota, USA
- Ian McNiece, PhD; Miami, Florida, USA
- Donna Salzman, MD; The University of Alabama Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program; Birmingham, Alabama, USA
- Joseph Schwartz, MD, MPH; New York Presbyterian Hospital/Columbia University Medical Center – Blood and Marrow Transplant Program; New York, New York, USA
- Elizabeth Shpall, MD; MD Anderson Cord Blood Bank; Houston, Texas, USA
- Gillian Woollett, MA, DPhil; Avelere Health LLC; Washington, District of Columbia, USA
- Abba Zubair, MD; Blood and Marrow Transplantation Program of Mayo Clinic, Nemours Children’s Clinic, and Wolfson Children’s Hospital, Jacksonville, Florida, USA
FACT Board of Directors Honors Carolyn Taylor for Years of Service
During its meeting at the ASH Annual Meeting in December 2016, the FACT Board of Directors honored Carolyn Taylor, PhD, for her many years of service and wished her congratulations on her upcoming retirement.
Dr. Taylor served as a Board member for 8 years, including 4 years as Vice-President. Her many other contributions to FACT include:
- Standards Committee Chair from 2010-2013 (also served as subcommittee co-chair and past-chair),
- Cellular Therapy and Cord Blood Accreditation Committee member,
- Regenerative Medicine Task Force member,
- FACTWeb Oversight Committee member,
- HLA Typing Accreditation Committee Chair,
- FACT representative for Worldwide Network for Blood & Marrow Transplantation (WBMT),
- Inspector (26 inspections performed), and
- Presenter/FACT representative at countless in-person and online events.
FACT and the cellular therapy community would not be what they are today without the time, expertise, and counsel Dr. Taylor selflessly gave to others. We wish her the fulfilling and enjoyable retirement that she deserves, and will appreciate the impact she had on our field for years to come.
NetCord to Become Working Group of WMDA
NetCord, the organization of leading cord blood banks and FACT’s partner in cord blood standards and accreditation, has joined with the World Marrow Donor Association (WMDA). Its activities will be incorporated into an expanded working group within WMDA that will take on NetCord’s important work. The working group’s new mission statement will be, “To support, promote and enhance safety, efficacy and availability of international exchange of cord blood units and to harmonize global practice of cord blood banking and supply.” It is also expected that this will enhance the cord blood community’s ability to focus on cellular therapy from cord blood products. Together, NetCord and WMDA will continue the strong leadership position carved out by NetCord in cord blood banking, with its abilities strengthened by the support of the WMDA. By joining WMDA, there will be a more efficient use of volunteers and their time, and require less overhead expenses.
Within the working group, NetCord’s members will continue to support the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and make accreditation decisions based on those Standards. Gesine Kögler, PhD, will serve as the official liaison to FACT. Dr. Kögler is a long-time member of the FACT Standards and Accreditation Committees. More details will be shared with the FACT community as they become available.
Dr. Kögler will give a presentation on the new relationship between NetCord and WMDA at the FACT Cord Blood Inspection & Accreditation Workshop at the ISCT Annual Meeting in London on May 2, 2017.
Updated Donor History Questionnaires Now Available
The interorganizational Donor History Questionnaire materials have been updated to reflect recommendations made by the FDA’s Guidance for Industry: “Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates,” published in November 2016.
The Donor History Questionnaire (DHQ) materials were developed to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, FACT, and the National Marrow Donor Program (NMDP).
The FDA does not mandate use of any particular tool to fulfill donor screening requirements for communicable disease risks and has determined that “official” recognition of DHQ materials in a guidance document is not warranted. The task force believes the DHQ materials, which are harmonized with applicable regulations and guidance documents, will optimize donor comprehension of the questions and provide donor historians with the tools needed to evaluate donor responses. Facilities should read the “User Instructions” carefully before adopting the materials for use.
When a facility implements a new version of these DHQ materials, it should follow its established change control process for the incorporation of the new DHQ materials. The change control process should address validation of the use of the new version with other existing processes and appropriate staff training.
Donor History Questionnaire for HPC, Cord Blood DHQ Version 1.3, December 2016
Help Your Inspectors Help You
On-site inspections are understandably stressful experiences. Organizations essentially invite others to come to their sites, look through their documents, watch their work practices, and record observations. Organizations that voluntarily pursue FACT accreditation want to do well, and it is natural to feel nervous about what inspectors may find while assessing their programs.
When preparing documentation for inspector review, it may be instinctively enticing to avoid showing inspectors everything. Limiting what inspectors see limits the amount of deficiencies they find, right? Wrong. Although it seems counterintuitive, more citations result from inspectors not able to find evidence of compliance.
Do not think of an inspection as a day to avoid doing anything wrong. Think of it as a day to proudly show all that your program has accomplished! The easier it is for inspectors to find and review documents, the easier it is for them to check “Compliant” on that ubiquitous inspection checklist. Showing documentation upfront on the day of inspection will avoid extra time and effort to describe the documentation when responding to deficiencies afterward.
Therefore, be ready to show inspectors audits, adverse event investigations, and urgent medical need documentation for ineligible donors. The purpose is not to show the inspectors any shortcomings; the purpose is to show inspectors your approach to quality management and continuous improvement. Organizations that act like they have something to hide will appear to have something to hide. Confidently showing inspectors your quality documents, procedures, and investigations demonstrates a commitment to quality.
FACT and its inspectors want organizations to do well, and that does not end with an accreditation certificate. The ultimate goal of FACT accreditation is to continuously improve. The more you show us, the more we will be able to help you and the better value you gain from the accreditation process.
Transporting Cellular Therapy Products Intended for High-Dose Chemotherapy Recipients
The FACT-JACIE Hematopoietic Cell Therapy Standards state, “If the intended recipient has received high-dose therapy, the cellular therapy product shall be transported.” (CM10.3.2, C10.3.2, D10.7) Some have asked what the purpose of this standard is because a product always needs to be distributed to the recipient.
The key word in this standard is “transported.” As stated by the FACT-JACIE definitions in Part A of the Standards, “transport” is the physical transfer of a cellular therapy product within or between facilities during which it does not leave the control of trained personnel at the transporting or receiving facility. In other words, someone who is trained to transfer a product must be with it at all times. This is in contrast to shipping, during which the product does leave the control of trained personnel (such as shipment on a commercial distributing company’s truck or airplane).
If a patient has undergone high-dose marrow ablative treatment in preparation for transplant, the cellular therapy product is essential for the patient’s survival since it may not be possible to obtain additional marrow or blood from the original donor or a second donor in time to prevent complications from aplasia. For this reason, it is important that the product be entrusted to a knowledgeable individual who accompanies it from the distributing facility to the receiving facility.
Congratulations to Our New Inspectors!
The following individuals completed their first active inspection from April 2016 through December 2016. Congratulations and thank you for volunteering your time and expertise to advance cellular therapy! Organizations with personnel who also serve as FACT inspectors typically perform better during on-site inspections than their counterparts without an inspector. If you are interested in serving as an inspector, submit an online application!
Ed Brindle, MSc, MLT
Cord Blood Processing
Insception Lifebank Cord Blood Program, Insception Biosciences Mississauga, Ontario, and Burnaby, British Columbia, Canada
Grace Banez-Sese, MD
Apheresis Collection
INOVA Fairfax Hospital/Fairfax Stem Cell Transplant Program
Parastoo Dahi, MD
Clinical Program and Marrow Collection
Memorial Sloan-Kettering Cancer Center- Blood and Marrow Transplant Program
Amer Beitinjaneh, MD, MS, MPH
Clinical Program and Marrow Collection
Adult Stem Cell Transplant Program at Sylvester Comprehensive Cancer Center/University of Miami Hospital & Clinics
Karen Klinker, MT (ASCP) SBB
Apheresis Collection
Dartmouth-Hitchcock Medical Center Blood and Marrow Transplant Program
Elias Kalouche, MBA, B.Sc., MLT (CSMLS)
Cellular Therapy Processing Inspector
Progenics Cord Blood Cryobank
Eddie Yoh, BSMT
Cord Blood Processing
StemCord Pte Ltd
Patrick Hanley, PhD
Cord Blood Processing
Children’s National Health System Blood and Marrow Transplant Program
Brian Jones, SBB (ASCP)
Cellular Therapy Processing
Blood Systems Laboratories Cellular Therapy Laboratory
Linda Moore, MT (ASCP)
Cellular Therapy Processing
University of Pittsburgh Medical Center, Adult Hematopoietic Stem Cell Transplant Program
Maria Rios, RN
Apheresis Collection
Miami Cancer Institute
Leon Su, MD, MBA, FCAP, FASCP
Apheresis Collection
The Blood and Marrow Transplant Program at Mayo Clinic Arizona and Phoenix Children’s Hospital
Alicia Garcia, RN, HSCP
Apheresis Collection
UCSF Benioff Children’s Hospital Oakland Apheresis Program
Sarah Heidtke, BS
Cellular Therapy Processing
Medical College of Wisconsin Blood and Marrow Transplant Program Children’s Hospital of Wisconsin and Froedtert Hospital
Susan Clarke, RN, BScN, MN, CON(C), CPMHN(C)
Apheresis Collection
UHN Blood and Marrow Transplant (BMT) Program
Mark Juckett, MD
Clinical Program and Marrow Collection Inspector
University of Wisconsin Madison Hematopoietic Stem Cell Program
Jo-Anna Reems, PhD, MT (ASCP) SBB
Cellular Therapy Processing
The University of Utah Blood and Marrow Transplant Program
Alex Babic, MD, PhD
Apheresis Collection
Saint Louis University Blood and Marrow Transplant Program
Pilar Gomez Maldonado, RN
Cord Blood Collection
Banco de Sangre de Cordón Umbilical Andalucia
Cord Blood Spotlight at ISCT Annual Meeting the Destination Event for Cord Blood Banks
This year’s destination event for cord blood banks will be at the 2017 ISCT Annual Meeting in London. Two days prior to the meeting, leading cellular therapy organizations will convene to provide education to cord blood banks in one convenient location. Plan to attend this one-stop opportunity to learn from FACT, CBA, ISCT, ASBMT, and world-renowned cord blood scientists and transplant physicians.
FACT Cord Blood Inspection and Accreditation Workshop
May 2, 2017
This training workshop will assist your cord blood bank with meeting stringent quality standards. The agenda will addressThe accreditation process;Changes to the Standards and the online accreditation portal;
NetCord’s integration with the WMDA; Challenging requirements for cord blood banks including cryopreservation, stability studies, and root cause analysis; and Requirements for FACT inspectors, including new inspector orientation.
Would you like to attend the workshop for FREE? Apply to be a FACT inspector. Approved inspectors attend educational activities at no cost.
View meeting details and register at factwebsite.org.
FACT-ISCT Cord Blood Quality Boot Camp
May 3, 2017
The boot camp will strengthen participants’ quality assurance knowledge through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee and the ISCT Planning Committee encourage everyone to review specific aspects of their cord blood banks’ quality program in the months leading up to the boot camp. During the boot camp, quality experts will present important concepts and lead roundtables where participants may ask questions and help each other reach their goals. Participants are strongly encouraged to register early and participate in the pre-conference assessment activities. Be sure to register for the boot camp AND complete the pre-conference informational survey.
Complete the Pre-Conference Survey
Register at ISCT2017.com
3rd ISCT-CBA Cord Blood Series, in Partnership with ASBMT
May 3, 2017
ISCT and the CBA, in partnership with ASBMT, are pleased to host the third Cord Blood Series as part of the Pre-Conference Day at ISCT 2017. Join Dr. Joanne Kurtzberg and Dr. Elizabeth J. Shpall for a full day of presentations and discussions with key leaders in the field about topics ranging from cell engineering to immunotherapy, and beyond.
Upcoming FACT Educational Events
QM Series 7: Improving Our Clinical Outcomes Virtual Roundtable
Wednesday, February 8, 2017
Online Webinar
This webinar will be on February 8, 2017, at 11:00 AM ET. This virtual roundtable will consist of three accredited organizations (including both cellular therapy programs and cord blood banks), who will share how they improved outcomes. Presenters will describe how they analyzed outcomes, what issues they found, and what they did to improve.
View meeting details and register online
Cellular Therapy Inspection and Accreditation Workshop
Tuesday, February 21, 2017
Orlando, FL
The blood and marrow transplant field has been a leader in voluntarily improving quality, and accredited Clinical Programs are currently adapting to several new FACT Standards and procedural changes to the accreditation process. This workshop will provide background on these changes. The morning workshop sessions include major topics such as clinical outcomes benchmarking, joint FACT/CIBMTR data audits, and immune effector cell requirements. FACT will also present information on the New FACT Accreditation Portal and demonstrate the overall application workflow for applicants and inspectors.
The afternoon session includes two different tracks: Accreditation Process and Standards. The Accreditation Process track includes sessions on the FACT accreditation process, being prepared on inspection day, trainee inspector orientation, and demonstrating compliance on inspection day. The Standards Track will highlight 6th edition common citations, outline donor management issues, clarify the 6th edition continuing education requirements, and discuss coordination of care. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend all four sessions in the Accreditation Process track. All other applicants may choose which sessions to attend in the afternoon and are encouraged to attend sessions in both tracks as they fit educational needs.
View meeting details and register online
Cellular Therapy Leadership Course at BMT Tandem – 101
Tuesday, February 21, 2017
Orlando, FL
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome.
In years past, participation in FACT’s leadership workshop has been by invitation. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
Participants in past years have been unanimous: “We just don’t receive this type of training in medical school or anywhere else” . . . “It was fun” . . . “So very well presented” . . . “Great group discussions” . . . “The workshop was beyond my expectations” . . . “Excellent interaction among participants” . . . “It should be a longer program – all day, or maybe two days.”
The highly interactive and participatory curriculum teaches leadership principles including:
• The leader as coach
• Differences between managing and leading
• Basic styles of leadership and how to recognize your own style
• When each style of leadership may be appropriate
• Running and participating in effective meetings
• How to build consensus
• Four proven ways to motivate people
• Effective delegation skills
• How to adapt to change, and even be a change agent
• Understanding and exercising governance roles and responsibilities
• Ten basic responsibilities of a governing board
• Legal implications of decision making and liability and fiduciary responsibilities
Woven throughout the leadership course is an overview of FACT’s organizational structure, purpose, challenges, current programs and accomplishments.
Whatever you lead, this course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.
View meeting details and register online
Cellular Therapy Advanced Leadership Course at BMT Tandem – 201
Tuesday, February 21, 2017
Orlando, FL
If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Topics include:
• Characteristics of a healthy organization
• Adapting an organization to a changing environment
• Multiplying and diminishing the effectiveness of a team
• Leading from where you are
• Servant leadership
• Effective governing boards
• Strategic planning with a focus on outcomes
Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
View meeting details and register online
FACT – ASBMT Quality Boot Camp
Wednesday, February 22, 2017
Orlando, FL
Join us for the FACT-ASBMT Quality Boot Camp at the 2017 BMT Tandem Meetings on February 22 in Orlando, FL. This year’s boot camp will expand upon last year’s core topics by bringing a unique perspective and new examples that will pertain to clinical programs. The boot camp will strengthen your quality assurance activities through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will encourage you in the months leading up to the BMT Tandem Meetings to review specific aspects of your quality program. Quality experts will then present important concepts and lead roundtables that allow participants to ask questions and help each other reach their goals during the boot camp. Participants are strongly encouraged to register early to participate in the pre-conference assessment activities.
Each month prior to the in-person meeting, registrants will receive a short survey that will encourage them to asses a quality management principle as it relates to their organizations (answers can be submitted anonymously if desired). The Quality Boot Camp will be designed around the challenges and successes illustrated by the results provided by registrants. Participants are also welcome to bring specific documents and questions to the meeting for advice.
Note: There is a nominal charge of $50 to cover catering for attendees.
View meeting details and register online
FACT Accreditation Portal Training
February 22 and 23, 2017
Introductory FACT accreditation portal training courses are open to applicants and inspectors who will use the New FACT Accreditation Portal. FACT’s IT Business Analyst will provide hands-on training of the system interface and demonstrate the overall workflow. There are two training sessions for applicants and two for inspectors.
FACT asks that you bring a fully-charged laptop to your session. Free Wi-Fi will be available. Sign up now to reserve your spot!
FACT Accreditation Portal Applicant Training February 22
FACT Accreditation Portal Applicant Training February 23
FACT Accreditation Portal Inspector Training February 22
FACT Accreditation Portal Applicant Training February 23
NetCord Webinar: Cord Blood Specifications
Wednesday, March 1, 2017
Online Webinar
This webinar will take place on March 1, 2017, at 11:00 AM ET. Dr. Gesine Kögler of the José Carreras Cord Blood Bank in Düsseldorf, will give an overview of the explicit specifications for CB units released for unrelated administration pertaining to the FACT 6th Edition Cord Blood Standards.
View meeting details and register online
CBA Webinar: Applying the NetCord – FACT Cord Blood Standards in Private Banking
Wednesday, March 15, 2017
Online Webinar
This webinar will be on March 15, 2017, at 11:00 AM ET. Sue Armitage, BSc, will discuss the how family cord blood banks can comply with the NetCord-FACT 6th Edition Cord Blood Standards, methods to overcome challenges, and the benefits to achieving FACT accreditation.
View meeting details and register online
Cord Blood Inspection and Accreditation Workshop
Tuesday, May 2, 2017
London, United Kingdom
This training workshop will help your bank take a step forward in cord blood banking. The well-rounded agenda will address:
~ The accreditation process;
~ Changes to the Standards, the online accreditation portal, and NetCord’s relationship with the WMDA;
~ Challenging requirements for cord blood banks including cryopreservation, stability studies, and root cause analysis; and
~ Requirements for FACT inspectors, including new inspector orientation.
Would you like to attend the workshop for FREE? Apply to be a FACT inspector! If you are approved, you can attend free of charge!
View meeting details and register online
FACT-ISCT Cord Blood Quality Boot Camp
Wednesday, May 3, 2017
London, United Kingdom
The boot camp will strengthen participant’s quality assurance knowledge through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee and the ISCT Planning Group encourage everyone to review specific aspects of their cord blood banks’ quality programs in the months leading up to the boot camp. During the boot camp, quality experts will present important concepts and lead roundtables where participants may ask questions and help each other reach their goals. Participants are strongly encouraged to register early and participate in the pre-conference assessment activities. Be sure to register for the boot camp AND complete the pre-conference informational survey.
Pre-Conference Survey
Register
3rd ISCT-CBA Cord Blood Series, in Partnership with ASBMT
Wednesday, May 3, 2017
London, United Kingdom
ISCT and the CBA, in partnership with ASBMT, are pleased to host the third Cord Blood Series as part of the Pre-Conference Day at ISCT 2017. Join Dr. Joanne Kurtzberg and Dr. Elizabeth J. Shpall for a full day of presentations and discussions with key leaders in the field about topics ranging from cell engineering to immunotherapy, and beyond.
Cellular Therapy Collection Workshop
Wednesday, May 3, 2017
Fort Lauderdale, FL
This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities. FACT representatives will be in attendance to clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
View meeting details and register online
