FACT committees have advocated for cellular therapy organizations on several fronts this past quarter, and we are seeing results.
The Technology Committee, with the hard work of FACT’s IT Business Analyst, Alisa Forsythe, launched the new FACT Accreditation Portal on October 1st. Organizations and inspectors were candid with their feedback on the online accreditation process, and the committee and Alisa listened and were responsive to those needs. We are pleased to deliver a faster, more streamlined portal that better serves our stakeholders.
Rapid development and recent commercialization of novel cellular therapies have brought new protocols and processes to accredited organizations. The FACT Immune Effector Cell Task Force is advocating for clear, manageable, and sustainable expectations of programs that have begun providing immune effector cell therapies. The FACT Regenerative Medicine Task Force has been sharing related lessons learned with organizations working to advance regenerative medicine in order to address challenges upfront. We also continue to facilitate open communication via the Professional Relations Committee, comprised of several related organizations.
Our work with the Center for International Blood and Marrow Transplant Research (CIBMTR) and one of our parent organizations, the American Society for Blood and Marrow Transplantation (ASBMT), continues on important issues, especially data management and clinical outcomes. The FACT-CIBMTR Data Audit Committee and the Clinical Outcomes Improvement Committee have been focusing on clear articulation of expectations of accredited programs, while also working to promote quality data and outcomes improvement in a manner that is least burdensome and most effective for those programs.
The Global Affairs Committee has been traveling the globe and continues to do so in an effort to bring quality hematopoietic progenitor cell transplants to more patients. In addition to accreditation workshops in conjunction with several international meetings, FACT recently formalized a joint accreditation program in Brazil.
The Standards, Education, and Quality Committees have been busy updating Standards and continuing educational programming to assist accredited organizations with staying current in developments in the field. These efforts are integral to the practical implementation of FACT requirements.
Finally, we are immensely appreciative of the Cellular Therapy and Cord Blood Accreditation Committees, chaired by Phyllis Warkentin, MD, FACT Chief Medical Officer. As all of the committees above continue their good work, growth in the accreditation program follows. The number of cellular therapy programs seeking voluntary accreditation continues to grow, giving the Accreditation Committee more reports to review, discuss, and assess. These reports are also growing in complexity as programs provide more diverse services to their patients, and the committee has been prudent with considering these complexities and maintaining consistency in its reviews. Members of the Cellular Therapy Accreditation Committee have committed to additional time to accommodate the increasing number of reports, demonstrating their commitment to FACT’s mission of quality cellular therapy.
We welcome your participation in FACT’s peer review and accreditation, as an inspector and as a committee member.
Dennis A. Gastineau, MD
In 2015, FACT began a monumental undertaking to replace the FACTWeb Portal. FACT’s vision was to create a new system that would revolutionize the accreditation process. The goal was to improve the applicant’s ability to efficiently submit evidence to FACT; enhance the inspector experience with a streamlined approach for reviewing compliance applications, clinical outcomes, and data management; improve inspector training; and increase system flexibility to allow FACT staff to seamlessly manage the accreditation process from start to finish.
This past April, 10 organizations were selected to serve as beta testers and complete their applications in the new portal. After a successful beta test period, the new FACT Accreditation Portal launched on October 1, 2018.
“This is a major improvement over the first portal. The ease of use and the speed are complete upgrades! I appreciate everything that was incorporated into this new portal and realize that we will continue to strive to improve it. Very pleased to have been a beta tester!” states Kim Kasow, DO of the UNC Bone Marrow Transplant and Cellular Therapy Program.
Applicants with pre-existing applications in the legacy FACTWeb portal will continue with the legacy portal until the current application is finished. Going forward, all new applications will be created in the new FACT Accreditation Portal.
FACT Accreditation Portal
Portal access: https://portal.factwebsite.org
- To apply for initial FACT accreditation, complete the request for access form accessible from the new portal login page.
- If your organization has been migrated to the new portal, complete the Recover Password form accessible from the new portal login page to access your account.
Training Materials: Portal Resource Center
Launch Details: FACT Accreditation Portal Launch Updates
To access an existing application in the legacy FACTWeb portal, navigate to https://www.factweb.org.
A very special thank you to all the people that contributed to this project:
- The FACT Technology Committee for their leadership and guidance throughout the project
- Our Beta Testers who courageously entered the new portal and took the time to explore and provide feedback
- FACT Staff for their patience through countless meetings, working sessions, and months of testing
- Our software developer, 5th Method, for their support and partnership throughout this project
WMDA-NetCord & FACT Events at the Inaugural Cord Blood Connect International Congress Were a Success
The WMDA and FACT hosted a Cord Blood Day at the 2018 Cord Blood Connect International Congress in Miami, Florida on September 14. Over 50 members of the cord blood community from fourteen different countries attended. The day included topics such as global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.
The WMDA and FACT were honored to have Dr. Eliane Gluckman in attendance at the WMDA-NetCord & FACT Cord Blood Day. She performed the first successful human umbilical cord blood transplant and, with colleague Hal Broxmeyer, PhD, successfully showed that unrelated cord blood could be used as a source of hematopoietic stem cells. Dr. Gluckman received the first Cord Blood Association (CBA) Lifetime Achievement Award, celebrating the 30th anniversary of that event.
In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth and hosted the first Regenerative Medicine InterCHANGE, during which several societies working to advance regenerative medicine discussed their initiatives and current challenges in the regenerative medicine field.
All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 13-15, 2019, in Miami Beach!
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 continues to develop its international collaborations through regional initiatives aimed at providing educational assistance and accreditation activities tailored to the needs of the global communities.
FACT-JACIE Stepwise Accreditation in Latin America
In an effort to provide an incremental approach to accreditation, FACT and JACIE have partnered to offer a stepwise accreditation program in Latin America. This stepwise approach to accreditation would enable programs to focus on their quality systems first and ensure operations for patient and donor safety. The second phase would build on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes. The first FACT-JACIE Stepwise Inspection is scheduled to be conducted in Argentina on November 20-21, 2018.
A broad group of ten participating bone marrow transplant centers throughout India is participating in the new India Working Group designed to address the regional needs of the country. The centers are completing self-assessments of their programs to identify any potential barriers to compliance with FACT Standards, clarify the intent of requirements, and assess their readiness for accreditation.
A FACT Standards and Accreditation Workshop was held on November 2, 2018 during the annual meeting of the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) in Taipei, Taiwan. Presentations included the importance of integrating a quality management system throughout the clinical, collection and cell processing activities; the accreditation experience of the National University Health System in Singapore; the incentives for seeking international accreditation from the Tata Medical Center in Kolkata; and the need for standardization and accreditation in China.
Following the execution of a formal Memorandum of Understanding (MoU) in August, FACT and the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) created a FACT-SBTMO Task Force. The first meeting of the Task Force was conducted on October 17, 2018 to review the strategic goals and operational aspects of the joint FACT-SBTMO Accreditation Program. A survey of the Brazil transplant centers will be distributed in November to gather data related to the volume and type of transplants performed, program structure, personnel, facilities, and quality management systems. The information will be used to identify areas of educational need and ascertain readiness for accreditation.
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 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.
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 November 30, 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 November 30, 2018 through March 1, 2019.
The final Standards will be published in October 2019.
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.
FACT invites you to take a step forward and serve as a volunteer FACT inspector. As a nonprofit organization that aims to provide accreditation services for the highest possible value, we rely on volunteer inspectors and the leadership of their accredited organizations to be supportive of their time and dedication to FACT activities.
Possibly the greatest benefit inspectors experience is the opportunity to give back to the field of cellular therapy and cord blood banking. There are also many other benefits enjoyed by inspectors, and their organizations, including:
- Learning new practices and techniques from other organizations;
- Networking with peers for ideas, questions, and collaboration;
- Sharing knowledge and expertise with others;
- Discovering a variety of ways to meet FACT Standards;
- Reflecting on their own organizations’ practices;
- Developing professional skills and accomplishments;
- Accessing FACT educational sessions free of charge; and
- Taking advantage of opportunities to serve on FACT committees.
Organizations with inspectors experience increased exposure to the cellular therapy and cord blood community and have more opportunities to provide feedback on the development of standards and accreditation requirements. There is also evidence that organizations without inspectors have more difficulty complying with current standards. While inspections do require some time away from work, this time is an investment in an organization’s knowledge of FACT requirements and various methods of compliance.
The following individuals completed their first active inspection in the time period from August through October 2018. 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! For a complete list of active FACT inspectors, view the online list of FACT Inspectors.
Anurag Singh, MD, MBBS
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, Marrow Collection
The University of Kansas Medical Center Blood and Marrow Transplant Program
Guy Klamer, PhD
Cord Blood Banking, Cord Blood Processing
Sydney Cord Blood Bank
Arvin Faundo, MD
Cord Blood Banking, Cord Blood Processing
Cordlife Group Limited
Prashant Nageshwar, MD
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy
Dana-Farber Cancer Institute
Marina Komarovskaya, MD
Processing: Minimal manipulation of HPC, and more than minimal manipulation of any cell type
Yale-New Haven Hospital Stem Cell Transplant Program
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.
FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR
Cellular Therapy Inspection & Accreditation Workshop
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 risk evaluation and mitigation strategies. 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.
FACT-ASBMT Quality Boot Camp
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.