By Mikaela VanMoorleghem, Education and Training Coordinator, Foundation for t he Accreditation of Cellular Therapy (FACT)
Join FACT for a Special Cord Blood Webinar in Support of World Cord Blood Day
In anticipation of World Cord Blood Day on November 15, 2018, FACT invites you to attend a special cord blood webinar on Wednesday, November 14, 2018 at, 10:00 am ET, 15:00 GMT, and 16:00 pm CET. Speakers include Dr. Éliane Gluckman, the first to perform a successful human umbilical cord blood transplant; Dr. Étienne Baudoux of Liège Cord Blood Bank; Dr. Diane Fournier of Hema-Quebec Cord Blood Bank; and Ms. Mai Duong, cord blood transplant recipient. The purpose of this webinar is to better understand the current challenges and coming opportunities in the field of cord blood. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:
- Successes and Challenges of Cord Blood Transplant: Dr. Eliane Gluckman
- Highlights from the FACT Quality Boot Camp held in September 2018 at the Cord Blood Connect International Congress: Dr. Étienne Baudoux
- Highlights from the first annual Cord Blood Connect International Congress held in September 2018: Dr. Diane Fournier
- Building awareness of stem cell donation: Mai Duong, cord blood transplant recipient
FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.
View meeting details and register
Register for Save the Cord’s live virtual conference
Instructions for joining the meeting:
- Log into Webinar
- Enter your name and email. Click "Join Now."
- If requested, enter the event number: 407 198 653
- Adjust computer audio to desired volume
Afin de complémenter la mission éducative que s’est donnée l’organisme Save the Cord Foundation dans le cadre de la Journée Internationale du Sang de Cordon, FACT vous invite à assister à un webinaire en français d’une durée d’une heure le 14 novembre 2018 à 9 am (HNC), 10:00 am (HNE), 15:00 GMT, and 16:00 pm (HNEC). Les présentateurs seront: Dr. Eliane Gluckman, qui a réalisé la toute première greffe de sang de cordon; Dr. Étienne Baudoux de la Banque de sang de cordon de Liège; Dr. Diane Fournier de la Banque de sang de cordon d’Héma-Quebec et Mme Mai Duong, une courageuse Montréalaise ayant reçu une transplantation de sang de cordon en 2014. Le but du webinaire est de mieux comprendre les défis actuels et les opportunités d’avenir dans le domaine du sang de cordon. Les sujets présentés seront les suivants:
- Introduction et contexte par le Dr Éliane Gluckman
- Résumé du FACT Quality Bootcamp qui s’est tenu le 14 septembre 2018 en amont du Cord Blood Connect Congress par le Dr Étienne Baudoux
- Points saillants de la première édition du Cord Blood Connect Congress qui s’est tenu les 15 et 16 septembre 2018 par le Dr Diane Fournier
- Sensibilisation au don de cellules souches: Mai Duong, greffée de sang de cordon.
FACT vous encourage aussi à vous joindre à une conférence virtuelle sur le sang de cordon présentée par Save the Cord Foundation le 15 Novembre 2018. Le programme comportera des présentations s’adressant à un large public sur les avancées récentes dans les traitements utilisant le sang de cordon par des chercheurs et transplanteurs de renommée international.
Voir les détails du webinar FACT sur le sang de cordon le 14 Novembre 2018
S’inscrire à la conférence virtuelle de Save the Cord Foundation le 15 Novembre 2018
Pour rejoinder le séminaire en ligne:
- Suivre le lien vers l'URL
- Entrer votre nom et adresse email, cliquer "Join Now."
- Si demandé, entrer le numéro de l'événement: 407 198 653
- Ajuster le volume du haut parleur au niveau desire
FACT Cellular Therapy Inspection and Accreditation Workshop at TCT
Now Open for Registration!
February 19, 2019
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:
- Overview of FACT Accreditation Processes
- Common Citations Overview
- Integration of Immune Effector Cells into Accreditation
- Using the Tracer Methodology to Assess Compliance with FACT Standards
- Risk Evaluation and Mitigation Strategies (REMS)
- How to Prepare for and Conduct Inspections
- Data Management
- Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management; personnel; and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and REMS. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
View meeting details and register
Register for the ASBMT-FACT Quality Boot Camp at the TCT Meetings
February 20, 2019
Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.
This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute self-assessments in the months leading up to the TCT Meeting to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessments, attending the in-person workshop, and joining the roundtable discussions.
View meeting details and register
FACT Regenerative Medicine InterCHANGE Generates Actionable Ideas
On September 17, 2018, FACT hosted a Regenerative Medicine InterCHANGE meeting in conjunction with the Cord Blood Connect congress in Miami Beach, Florida. Lessons learned from the commercialization of immune effector cells indicate that proactive change management is key to linking the needs and interests of all involved in advancing regenerative medicine. The purpose of the meeting was to create awareness and discuss challenges identified with the development, testing, and commercialization of novel cellular therapies in regenerative medicine.
The first half of the meeting was allocated to organizational introductions, during which each participating organization briefly presented information about its mission and initiatives related to regenerative medicine. Presenters mentioned several examples of collaboration with other attendee organizations, and audience members stated that the presentations enhanced their awareness and understanding of other stakeholders and their complementary objectives.
During the second half of the meeting, Dr. Ian McNiece, chair of the FACT Regenerative Medicine Task Force, moderated a discussion of challenges related to implementation of novel cellular therapies. Common themes throughout the discussion included data, standardization, accreditation, gaps in legislative policies, cost of goods and reimbursement, relationships between academia and industry, and early professional education.
The FACT Regenerative Medicine Task force will draft a summary of the meeting and distribute this document to all participating organizations for review and input. After all organizations complete this review, the summary will be distributed to stakeholders.
FACT Standards Committee Announcements
The FACT Standards Committees thank you for your continued feedback on FACT Standards during the various steps in the development process. The FACT Common Standards for Cellular Therapies and the NetCord-FACT Cord Blood Standards are currently under revision. Updates for these Standards are provided below. As progress continues, important updates for each set of Standards will be announced via weekly emails and future Just the FACTs newsletters.
FACT Common Standards for Cellular Therapies, Second Edition
The FACT Common Standards Steering Committee completed its review of the 257 public comments submitted on the draft second edition of the Common Standards. Your feedback is greatly appreciated.
The second edition is scheduled for publication on March 15, 2019. These Standards represent the basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.
NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Seventh Edition
The NetCord-FACT Cord Blood Standards Steering Committee met at the 2018 Cord Blood Connect International Conference in Miami, FL on September 13, 2018 to review the draft seventh edition of the Cord Blood Standards.
On December 1, 2018, the draft seventh edition Standards and accompanying Accreditation Manual will be published for inspection and public comment for a 90-day period. Comments will be accepted from December 1, 2018 through March 1, 2019.
The final Standards will be published in October 2019.
Evaluating Causes of Death to Improve Survival
Evaluating one-year survival, and the impact of efforts to improve survival, are challenging tasks for both FACT and accredited Clinical Programs. Hematopoietic progenitor cell (HPC) transplantation itself is complex before considering the confounding variables and unique patient characteristics required for outcome analysis. Many programs’ corrective action plans hint at a common struggle – where to start?
Risk-adjusted measures will always have weaknesses. Data definitions are necessary but can be rigid. Socioeconomic and geographic characteristics often have an impact but are difficult to measure. The sickest of patients needed alternatives, too. It is easy to feel that a program’s performance against comparative, risk-adjusted data is somewhat out of its control.
The FACT Clinical Outcomes Improvement Committee suggests programs start with cause of death, in a very literal sense. Identification of specific causes of death serves as a starting point for investigation. A quantitative, data-driven approach prevents inaccurate assumptions, especially in emotionally-charged situations. For example, high-risk patients need alternatives and programs may choose to approve them for transplant. By looking at causes of death, programs can focus on improvements within their control, such as risk-stratified approaches to choosing preparative regimens to address deaths caused by transplant-related mortality.
For U.S. allogeneic transplant programs, cause of death reporting is subject to rules set by the Center for International Blood and Marrow Transplant Research (CIBMTR). CIBMTR provides an easily accessible Forms Instruction Manual at http://www.cibmtr.org/manuals/fim. Among many subjects in this online manual, the CIBMTR lists rules for cause of death codes. There are several training and educational resources, also, and can be found on CIBMTR’s Training and References webpage. (For resources on the broader topic of the CIBMTR and FACT joint data audit program, visit FACT’s Data Management Resource Center.)
Clinical Programs are also encouraged to use internal data for outcome analysis. Internal cause of death data is not just helpful, but important. There are often contributory, secondary causes of death in addition to the primary cause. For example, a pediatric program may have a high rate of deaths caused by multi-organ failure, contributed by infection related to a high proportion of patients transplanted for an immunodeficiency. Programs may seek not only improvements in infection control, but also take actions to shorten the time to transplant or use granulocyte transfusion protocols.
Cause of death data can make the path toward outcome analysis and improvement clearer. Such data prevent incorrect assumptions, are available to both large and small programs, and provide a starting point for the complex process of evaluating one-year survival. Thank you for your efforts to improve survival of transplant recipients, and we will continue to share lessons learned via the FACT accreditation process.
Data Management Resource Center Available on FACT Website
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews a program’s most recent CIBMTR data audit results including implementation of the corrective action plan (CAP), adequacy of the CAP, and effectiveness of the CAP. The committee’s goal is to provide education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
To assist programs, the FACT-CIBMTR Data Audit Committee developed a Data Management Resources Center. This center contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
Defining, Assessing, and Documenting Cord Blood Warming Events
November 29, 2018
Anytime that the temperature is above -150° C should be considered a potential warming event. Because unit volumes are small and are frozen in bags with large surface areas, their thermal kinetics are greatly affected by their environment. Join Phillip Johnson MMedSc(Path), BAppSc(MedSc), Production Manager at Queensland Cord Blood Bank at the Mater, on November 29, 2018 at 3 pm ET, for a presentation regarding methods used to define, assess, and document cord blood warming events.
Requirements for Non-Fixed Cord Blood Collection Sites
December 5, 2018
Join Dr. Linda Peltier of McGill University Health Centre Stem Cell Transplant Program, on Wednesday, December 5, 2018, at 11:00 am ET, 16:00 GMT, for a webinar, FACT Requirements for Non-Fixed Cord Blood Collection Sites. Dr. Peltier will discuss the applicable FACT Standards for non-fixed sites including written agreements, supplies, transportation, training, and communication.
The Parts and Pieces of Validations and Qualifications
January 9, 2019
Join FACT for a webinar on validations and qualifications on Wednesday, January 9, 2019, at 11:00 am ET, 16:00 GMT. Dr. Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic Health Center, will discuss the essentials of validations and qualifications and the FACT-JACIE Seventh Edition Standards requirements.