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.
Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. 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.
Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
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. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
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 a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
The Foundation for the Accreditation of Cellular Therapy (FACT) invites international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.
FACT Inspectors are Invited to Social Hour during TCT Meetings
In honor of their dedication and service provided to the cell therapy community, FACT Inspectors are cordially invited to attend the FACT Inspector Social Hour on Friday, February 22, 2019 at the Hilton Americas-Houston Hotel, Room 335B from 5 pm – 6 pm. Light hors d’oeuvres and cocktails will be provided.
Visit FACT at Exhibit Booth 2254!
During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.
Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.
2019 TCT Exhibit Booth Hours:
Wednesday, February 20
7:00 a.m. – 2:00 p.m.
Thursday, February 21
7:00 a.m. – 2:00 p.m.
Friday, February 22
7:00 a.m. – 1:00 p.m.
Saturday, February 23
7:00 a.m. – 1:30 p.m.
QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.
FACT Cellular Therapy Collection Workshop at 2019 Annual ASFA Meeting
May 15, 2019
Join FACT on Wednesday, May 15, at the Hilton Portland Downtown in Portland, OR, for a workshop 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 discuss cellular therapy collection challenges, provide examples on how to maintain quality when faced with different collection protocols, and present a common citations overview. This workshop also includes inspector trainee sessions on how to perform a FACT inspection from start to finish.
FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
This workshop will provide well-rounded information on the process of accreditation, requirements in the FACT Standards, and how immune effector cellular therapy fits within the realms of cellular therapy and cord blood banking. This event is a must-see opportunity for the following audiences.
- Blood and marrow transplant (BMT) programs
- Cord blood banks
- Cell processing laboratories
- Physicians, scientists, and principal investigators
- Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
- Quality managers
Separate tracks will be available for cellular therapy programs and cord blood banks, followed by training specific to inspector trainees.
ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting Pre-Conference Day
May 29, 2019
Is your cell processing facility FACT accredited or looking to comply to FACT standards? Strengthen your quality assurance program through this interactive workshop with FACT experts and real world applications.
Focused on issues identified by FACT-compliant transplant programs, these sessions will include activities and discussion in four main topic areas. Come prepared with your quality program questions and leverage quality experts to identify process improvement opportunities you can apply at your organization.
FACT Cellular Therapy Inspection and Accreditation Workshop at CBMTG Annual Meeting
June 5, 2019
Calgary, Alberta, Canada
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including:
o Overview of FACT Accreditation Processes
o Common Citations Overview
o Integration of Immune Effector Cells into Accreditation
o Using the Tracer Methodology to Assess Compliance with FACT Standards
o Risk Evaluation and Mitigation Strategies (REMS)
o How to Prepare for and Conduct Inspections
o Data Management
o 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. 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.
WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the 2019 WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 12, 2019, in conjunction with the Cord Blood Connect International Congress.
The WMDA-NetCord & FACT Cord Blood Day will highlight recent advances in cord blood transplantation and include global perspectives of cord blood transplants, common FACT-NetCord inspection citations, and more. The afternoon consists of two breakout sessions: a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Registration fees are waived for FACT active and trainee inspectors. Apply to be a FACT inspector!
The FACT initiatives highlighted in this newsletter demonstrate a continued commitment to advancing quality and progress in cellular therapy. When FACT was formed 20 years ago, its founders were pioneering the inclusion of quality principles and peer-to-peer accreditation in cellular therapy. Their efforts expanded access to transplant, protected transplant from over-regulation, and improved processes to promote good patient outcomes.
This year, we have seen an inflection point in cellular therapy and FACT is leading efforts to take our abilities to the next level:
- Clinical Programs now have increased guidance to evaluate one-year survival and take action when it does not meet expectations.
- FACT’s focus on data management has evolved into a continuous improvement process to build upon findings during CIBMTR audits.
- Transplant centers and hematology/oncology departments will soon have peer-developed Standards to guide their immune effector cell programs.
- Our voices have been heard by the U.S. Food and Drug Administration and several collaborative societal initiatives.
- FACT Consulting Services meets the needs of cellular therapy organizations that desire a higher level of assistance.
- New specialties, such as cardiology, are beginning to see the benefits of a culture of quality.
- Underserved regions, such as Latin America, are poised to meet our Standards.
This is an exciting time to be a part of FACT, and we hope everyone who has participated on a FACT committee, served as a FACT inspector, prepared an organization for FACT inspection, and complied with FACT Standards is proud to be a part of our enduring but growing movement. The world is watching us, and we are honored to play a part in improving the lives of our patients.
Dennis Gastineau, MD
Unlike allogeneic transplants in the U.S., there is no risk-adjusted report of one-year survival for autologous transplants. There are a variety of risk-adjusted survival registries around the globe, but not for every region. Yet Clinical Programs are expected to benchmark their survival to comparative data and take corrective action. One of the most common questions we receive from autologous-only or non-U.S. programs is, “Where do we find data on one-year survival for autologous transplants?”
The FACT-JACIE Hematopoietic Cell Therapy Standards do not prescribe any specific data source to use for autologous benchmarking. The following are ideas to consider:
C.W. Bill Young Cell Transplantation Program
- S. Patient Survival Report: The U.S. Patient Survival Report displays an estimate of the number of patients who are alive after a bone marrow or umbilical cord blood transplant. The estimates are shown:
- By disease and length of time after transplant (including one year)
- By the type of donor who provided the cells for transplant:
- Autologous (the patient’s cells)
- Related allogeneic (a patient’s sibling or another family member’s cells)
- Unrelated allogeneic (a volunteer donor’s cells)
- The cells used for transplant (bone marrow, peripheral blood, or umbilical cord blood)
Be the Match/National Marrow Donor Program
- Disease-Specific HCT Indications and Outcomes Data: The outcomes data presented here are based on more than 50,000 unrelated donor transplants NMDP facilitated, plus autologous and allogeneic transplant data reported to CIBMTR® (Center for International Blood and Marrow Transplant Research). This CIBMTR data and analysis are based on more than 330,000 patients from U.S. and global transplant programs.
Peer-reviewed Medical Literature
- Scholarly articles examining multi-center one-year survival using relevant disease, donor type, and date range.
FACT Consulting Services, a subsidiary of FACT, offers a fee-for-service resource that matches client organizations with a consultant that meets their specific needs.
FACT recognizes that each cell therapy program is unique, and its needs are always evolving. We understand that there will be seasons when you have all the skills and experience necessary for quality management and accreditation readiness, and that there will be other times when help is needed or prudent. In those instances, program depth and breadth can be gained through experienced FACT consultants.
The FACT Consulting Menu of Services has been expanded to meet the growing demands of the cell therapy field and includes but is not limited to:
- Compliance Assessment
- Policy Review
- Policy Development
- Application Assembly
- Mock Desktop Review
- Mock On-Site Inspection
- Continuous FACT-Readiness
- Quality Management
- Training Workshops
If you don’t see a service that meets your exact needs in the list above, please explain your unique situation and opportunities to us. We know that transplant centers, cord blood banks, and regenerative medicine programs vary in volume, size, structure, and markets. Therefore, customized services are essential to meet specific needs. Chances are the necessary experience can be found among our consultants for the services that you need.
We are here to help and the place to begin is a phone call (402.559.1185). You will have the chance to explain the challenges and opportunities that your organization is facing and the outcomes that you want to achieve, and she will help you identify and select the services most beneficial for your organization’s needs. For more information, visit the FACT Consulting website.
Patrick J. Hanley, PhD, is the Laboratory Facility Director for cellular therapy and stem cell processing at Children’s National Health System. In addition to GMP regulations, Dr. Hanley is interested in improving outcomes after stem cell transplantation, including bone marrow transplant and cord blood transplant. He currently sits on the Immunotherapy committee of the International Society for Cellular Therapy (ISCT) and co-chairs its Early Stage Professionals committee. Since 2013, Dr. Hanley has been a FACT inspector and inspects both cellular therapy and cord blood banking processing facilities. In addition to volunteering as an inspector, he is a member of the FACT Cellular Therapy Accreditation Committee and Cellular Therapy Processing Facility Standards Committee.
Dr. Hanley shares his insights into why he became an inspector, and the benefits he has gained from this experience.
Becoming a FACT Inspector
I became interested in becoming a FACT inspector a bit serendipitously. I noticed a FACT Inspector Brochure in Dr. Catherine Bollard’s office that listed advantages of being an inspector. What I found appealing was the opportunity to travel to some of the most well-known, cutting edge facilities in the world and learn how they function. How do they train staff? How do they qualify critical reagents and handle inventory control?
After verifying my education and experience made me eligible, I asked Dr. Helen Heslop what the first step is to become a FACT inspector. She directed me to the FACT website and the online inspector application. After completing initial training requirements, I performed my training inspection with Dr. Monika Smogorzewska. I found the information obtained through this visit invaluable when we had to develop our own cell therapy facility at Children’s National in 2013. Since my first inspection in 2013, I have performed an average of two inspections per year.
Learning from Inspections
I really look forward to learning new information when I perform a FACT inspection. One of the aspects of the inspection process that I’ve found valuable has been the opportunity to visit other facilities and gather new ideas. For example, I trained at Baylor College of Medicine, which is quite a large academic facility. Our facility at Children’s National is significantly smaller and I am always looking for ways to improve our productivity and make more out of the existing space. I am also looking towards the future to identify aspects of various facilities that I would like to include in the new facility we have planned.
Children’s National has its challenges and areas where improvement is needed, which is no different than other FACT-accredited programs. As an inspector, I have the unique opportunity to see (for FREE) how other institutions handle similar challenges, and hear from others what works and what does not. The staff at Children’s can usually tell when I’ve been on a FACT inspection because I come back with a list of questions and suggestions based on my recent experience. Recently, after returning from an inspection, I asked for our transient warming validation and where we documented the length of time that the product was out of the freezer.
One experience of mine that was striking was while performing a more-than-minimal manipulation inspection at an institution. The site volunteered to show me its Investigational New Drug (IND) Application for one of its clinical trials. We have our own clinical trials, but to see how another group writes their Chemistry, Manufacturing, and Controls (CMC) section of the IND was fascinating. I walked away quite impressed with the effort they put forth qualifying their critical reagents.
Observing Frequent Deficiencies
One deficiency that I have found to be quite common is D4.14, which states that tests must be validated for their intended purpose. Where most sites fall short is that they use the BacT/Alert or BacTec sterility tests that have been validated for whole blood, but not cell therapy products. Another deficiency that is often overlooked is the expiration date of supplies and reagents – especially ethanol and disinfectants.
A standard that I think is critically important that is often cited is the annual report on the progress of the quality program. I think the majority of groups have regular meetings that meet the standard, but they fail to discuss how well the quality program is working, and what the problem areas have been over the past year. Similarly, as more and more programs start to use therapeutic cells (such as donor lymphocyte infusions) or cells under a clinical trial, these protocols are sometimes overlooked and outcomes are not always reported.
Preparing for Inspections
As an inspector, reviewing the documentation as early as possible is an absolute must so that you have the opportunity to request additional information as needed. More and more sites are requesting accreditation for more-than-minimal manipulation, and looking over the documents early provides me with the opportunity to determine what is being extensively manipulated. It also allows me to speak with the FACT office if needed about whether the program meets the criteria or not.
Another suggestion is to reach out to your peers who are inspectors for ideas. My mentor for my recent cord blood training inspection sent me a list of items for which he wanted to request more information from the bank. When he followed that up with a second checklist, it was a very enlightening moment for me; so much so that I scanned the list and saved it to my desktop (thanks Ping!).
Blood and marrow transplant programs continue to advance their field, cord blood banks look to maintain quality inventories and find new uses for cord blood, and oncology and regenerative medicine investigators are finding new ways to harness the power of cellular therapy. FACT does its part by drafting standards to support progress. FACT is especially grateful to the experts – from transplant physicians, oncologists, cardiologists, plastic surgeons, laboratory scientists, nurses, and quality managers – for keeping the spirit of FACT centered on expert and peer advice and leadership.
The following are updates from Standards development activities.
7th Edition FACT-JACIE Standards Under Development
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is currently drafting the 7th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. The Steering Committee met in Barcelona, Spain in June 2016 to discuss what worked well under the 6th edition, opportunities for improvement, and new developments in the field that should be considered.
Subcommittees comprised of clinical, collection, processing, and quality management professionals are completing their first reviews this fall. Upon approval of the Steering Committee and the FACT and JACIE leadership, the draft will be published for public review and comment. The public comment period is planned for April through June 2017.
A full committee roster can be found on the FACT website.
FACT published a draft of the 1st edition FACT Standards for Immune Effector Cell Administration for inspection and public comment. 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. These Immune Effector Cell 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.
In addition to the stand-alone set of Standards for non-blood and marrow transplant programs that use immune effector cells (such as a dedicated leukemia service), FACT also proposed the new requirements to be published as interim standards within the FACT-JACIE Hematopoietic Cell Therapy Standards.
Comments were solicited from a wide variety of stakeholders, from transplant centers, oncologists, professional and scientific societies, regulatory agencies, and drug manufacturers. The FACT-JACIE Standards Committee and the FACT Immune Effector Cell Task Force are reviewing the comments and making changes as appropriate. Final publication of the Standards is expected by the end of the year.
Although comments are no longer being accepted, the draft Standards and accompanying documents can be found online for review.
6th Edition NetCord-FACT Cord Blood Standards Become Effective
NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in July 2016, and the new requirements became effective at the end of September.
The most notable changes to the Standards was the inclusion of a list of required specifications for cord blood units stored for future clinical use. Specifications for both unrelated and related units related to cell counts, viability, potency, sterility, donor screening and testing, and identity are specified in Appendix V Specification Requirements for Cord Blood Units Stored for Clinical Administration. For related CB units, if specifications are unmet, the CBB at a minimum must follow its processes for deviations and nonconforming units in the event a customer insists on storage.
FACT Takes First Steps Toward Standards for Cardiovascular Cellular Therapy
The FACT Regenerative Medicine Task Force is responsible for identifying new specialties for which cellular therapy is a viable option, and learn from experts in those fields how standards and accreditation may be of value. The task force chose to first explore cardiovascular cellular therapy, because of progress made in these trials and a demonstrated evidence of peer to peer collaboration in the field.
FACT has been working with the Cardiovascular Cell Therapy Research Network (CCTRN) to evaluate the FACT Common Standards for Cellular Therapies for applicability to cardiovascular cell therapy and to observe and learn from member institutions. The Interdisciplinary Stem Cell Institute (ISCI) of the University of Miami Miller School of Medicine, led by Joshua M. Hare, M.D., F.A.C.C., F.A.H.A, completed a self-assessment of its cardiac cell therapy program against the Common Standards and then hosted FACT on September 15, 2016. ISCI representatives Aisha Khan and Darcy DiFede led FACT representatives on a tour of all involved hospital departments, indicated how compliance with Standards would be documented for a cardiac patient, and discussed cardiac-specific requirements that might be considered for future standards.
U.S. News and World Report released its 2016 Best Hospitals List, and FACT accreditation was again used as a ranking criterion for the cancer specialty. Since 2007, accredited programs receive a point value based on their accreditation. This year, programs that were accredited as of March 1, 2016 received one point if accredited for autologous transplants and two points if accredited for allogeneic transplants or both. Of the 50 best hospitals in the cancer specialty, all are FACT-accredited. Congratulations to these programs!
FACT and CIBMTR are pleased to announce our long-awaited collaborative program of data auditing, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. In this collaboration, the joint FACT-CIBMTR Data Audit Committee acknowledges the importance of complete and accurate data for self-assessment in individual hematopoietic cell therapy programs, for research and outcome reporting, and for compliance with FACT-JACIE Standards.
The essential elements of the collaboration are:
- FACT clinical inspectors will no longer perform a data audit at the on-site FACT inspection. This will eliminate the need for data sheets to be prepared only for FACT inspectors, and allow the clinical inspector to focus on adequacy of corrective actions and quality improvement.
- All verification of the accuracy of data against source data will be performed by the CIBMTR audit teams on site according to their current practices and schedules. The current CIBMTR process will not change.
- The FACT-CIBMTR Data Audit Committee will review CIBMTR audit reports and corrective action plans to assess compliance with Standards, implementation of effective corrective action, and improvements.
- Timeliness and completeness of data submission will also be assessed by the Committee using CPI reports from CIBMTR indicating “in good standing”.
On-site, FACT clinical inspectors will have access to this information and CIBMTR reports. The expectation is that clinical inspectors will look at documentation of internal data audits and implementation of corrective action plans (CAP). Where data management is outstanding and there are no corrective action plans to review, the on-site inspectors may ask to see these commendable practices that have resulted in exemplary data management.
Over the years, both FACT inspectors and CIBMTR auditors have continued to observe some programs and personnel who struggle with data accuracy and completeness. We hope that intensified support between inspections, increased emphasis on implementation of CAPs, and follow up to document continuous improvement will assist programs in data management improvement. We also hope the expertise in commendable practices in data management can be more widely shared and adopted where problems are being encountered. Ultimately, successful FACT accreditation will depend on satisfactory progress through these stages.
The following are answers to frequently asked questions. There are still some details to be finalized; however, do not hesitate to contact Heather Conway, Quality Manager in the FACT office (firstname.lastname@example.org or 402-559-1968) if you have concerns or questions.
- When will this start?
The new data audit program will be phased in starting late fall, 2016. Programs submitting an Annual Report or Renewal Application to FACT after this time will find new questions related to data on those reports. Programs that have already submitted renewal applications will notice there is no change in the upcoming inspection. There may be some overlap in processes as reports and applications are not always received in an orderly manner.
- How does this help my program?
FACT-accredited programs will no longer have to prepare data sheets for review by the on-site FACT inspector and will not have a data audit during the on-site FACT inspection. Programs will have the opportunity for enhanced review of corrective action plans and assistance with self-audits and other follow up to ensure compliance and improvements are made following any CIBMTR audit. Programs with outstanding Data Management will have the opportunity to share their expertise with their colleagues in webinars, writing, or other educational forums and be recognized for their accomplishments. On-site clinical inspectors will review internal quality management activities that support improvement in data management. Commendable practices in Data Management will be available to programs and persons to adopt as appropriate to their setting.
- What will this cost us?
There is no added cost to accredited programs for this collaborative process.
- How will the FACT inspectors be trained?
Over the next months, webinar presentations and written materials will be made available to current FACT inspectors. FACT Staff will observe portions of a CIBMTR audit to gain understanding and assist in training. This collaborative program will also be covered at the FACT Inspector Training at Tandem Meetings in February 2017. FACT Coordinators will be trained and will work with each program and inspector to ensure needed information is available.
- If we have had difficulty with our CIBMTR audits, will we lose our accreditation next year?
Not immediately. Initially, centers will be given a grace period to show improvement in critical field and random error rates. During this time, programs will be expected to learn from prior difficult audits, design appropriate investigations, implement effective corrective actions, and follow up to ensure that improvements are sustained. This new process is designed to help you identify the issues that may be barriers to improvement and to develop strategies to be successful. When this process has been fully implemented, FACT-accredited programs will be required to remain in good standing with the CIBMTR data audit program.
- How will the FACT and CIBMTR schedules change to accommodate this program?
There will not be a change in either FACT or CIBMTR schedules for on-site visits. CIBMTR audits will remain every four years as scheduled (unless you request and pay for an interim special audit). You will respond to these audits to the principal auditor as usual and according to the time frames defined by CIBMTR. FACT will receive information from you annually, and will manage the processes on an on-going basis, depending on the needs of the program. FACT on-site inspections will continue to occur every three years.
- Will the CIBMTR auditors know this is happening?
Yes. This process is intended to be completely transparent. Over the next several months, educational presentations will be available for CIBMTR staff related to FACT-JACIE Standards, the FACT accreditation process, and this data management collaboration. The committee charged with implementation of this program is a combined FACT-CIBMTR committee, with representation from both organizations.
- If we submit a corrective action plan to CIBMTR related to consent issues, will FACT review these also?
No. While FACT does have Standards related to informed consent, the consent issues managed by CIBMTR are outside the scope of this data project.
- If we fail a CIBMTR audit, will we have to request and pay for a special interim audit?
Not necessarily. This option is open to you; however, there will be other mechanisms defined through which you should be able to demonstrate appropriate implementation of corrective action and improvements in data management.
- Will we still have to submit a patient accrual list to FACT?
Yes. The patient list is used in many ways by the FACT staff to document new patient numbers, pediatric and adult recipients, and types of transplants.
- What happens if I disagree with the CIBMTR audit results?
There is no change in the processes available through CIBMTR to appeal or further discuss the results, either individually or cumulatively. FACT will not intervene in these processes.
Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario in Mexico received internationally recognized FACT accreditation. Directed by David Gomez Almaguer, MD, this is the first and only cellular therapy program in Mexico to be recognized by FACT. The bank 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. “We are proud of achieving FACT accreditation and being one of the few internationally recognized transplant centers in middle-income countries,” stated Dr. Gomez Almaguer. “This big leap forward ratifies our team’s constant efforts in providing the best care and high quality products for our patients. FACT Accreditation will undoubtedly drive us forward in the search for better stem cell research and development.”
Dr. Phyllis Warkentin, FACT Chief Medical Officer states, “The Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario has established a quality cell transplantation program and is leading the field in Mexico. I congratulate the program for the incredible work they have done, and their dedication on being the first in their region to achieve this honor.”
¡Felicidades por su acreditación!
The 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, FACT’s Chief Medical Officer, 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 our parent society, ISCT, in its position on unproven therapies and agree 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. Possible solutions to this problem include:
- Determination of “homologous use” could be not dependent on initial categorization of the whole tissue, but allow for cells and structural elements to be considered individually. The term “such HCT/P” could then be used to apply to either the cells or the structural elements, depending on intended use in the recipient.
- The term “homologous use” could be broadened to include any function or functions performed in the donor, not only the “basic function”.
- The Agency could recognize “standard of care” exceptions for certain procedures that have long been in place without such tissue regulation; those procedures in which data exist related to practitioners, procedures, and safety. Breast reconstruction is an example of this potential exception.
- There appear to be some inconsistencies in the definitions and examples of homologous use that would benefit from clarification.
- Although various phrases are used for the definition of homologous use, such as “perform the same basic function or functions” and “perform one or more of the same basic functions,” the examples seem to ignore the concept of more than one function of a tissue.
- The following example is also confusing to many: the guidance documents consider it to be non-homologous to put adipose tissue into breast tissue, since the basic function of the breast is lactation, ignoring the role of fat in support and shape. Yet it is considered to be homologous to put islets into liver, even though the primary function of liver is not glucose homeostasis.
- 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. For example, cord tissue is often collected, cryopreserved, and stored as whole tissue when the future use is undetermined at collection and storage, but it is likely intended for patient treatment. To ensure this tissue is considered to be a usable starting material in the future, the current regulatory pathway is unclear. In contrast, cord tissue may be significantly processed after collection, prior to cryopreservation and stored with the clear intent to use as MSCs or other product for an undetermined recipient.
- International harmonization is important to facilitate product development and world-wide availability of cell-based therapies for patients.
Dr. Warkentin’s full presentation is available online.
Allogeneic transplant programs in the U.S. are required to submit corrective action plans to FACT when they do not meet the expected range of one-year survival in the CIBMTR Transplant Center-Specific Survival Report. To adequately assess lower-than-expected one-year survival, it is necessary to fully understand how the report is generated.
CIBMTR explains the report methodology in the document titled, Methodology Employed for Annual Report on Hematopoietic Cell Transplant Center-Specific Survival Rates. The document provides technical information on statistics, but offers the following summary: “A censored data logistic regression model is fitted to survival data for first unrelated and related donor hematopoietic cell transplants at U.S. centers. The model is adjusted for recipient age; recipient race/ethnicity; Karnofsky/Lansky score; coexisting disease (Sorror HCT-CI); recipient CMV status; disease/status; interval from diagnosis to transplant (ALL and AML only); NHL subtype; resistant disease (NHL and HL only); CLL and other chronic leukemia stage; prior autologous transplant; year of transplant; donor type/graft type/HLA matching; donor/recipient gender match (bone marrow or PBSC only); and donor age (unrelated donor bone marrow or PBSC only). The report on transplant center-specific survival rates helps to identify centers that may have performed above or below confidence limits compared to the overall network of transplant centers . . .”
CIBMTR also explains the report, and its tools and resources to help Clinical Programs use their data, in the FACT webinar recording titled, Using CIBMTR Data to Determine and Evaluate Clinical Outcomes, presented by Stephen Spellman, MBS. This recording gives an overview of how CIBMTR data is used to determine outcomes and how Clinical Programs can use additional data to further evaluate outcomes and improve.
The following are common points Clinical Programs make about the CIBMTR report, and how they can be evaluated in the context of creating corrective action plans to address lower-than-expected one-year survival:
- High-risk patients: Some corrective action plans stated the root cause of death to be transplants for high-risk patients. As outlined above, the CIBMTR report is risk-adjusted. High-risk patients should be accounted for within the report. The FACT committee expects corrective actions that specifically address the causes of death. Broad refusal to transplant patients with high risk is not the intent of FACT requirements. As transplants are often the last hope for patients, careful attention to trends in causes of death is particularly important for these patients to improve their outcomes. For example, some programs have determined myeloablative therapy was not necessary or beneficial for a group of frail patients; another adjusted its protocol for preparative regimens.
- Small programs: It is difficult to identify trends among a small number of transplants, but FACT will look for a good-faith effort of the program to review data and determine if a trend can be found. One small program found that its patients had a high rate of CNS disease, and is educating its network of referring physicians.
- Confidence interval: A common worry is that Clinical Programs will have one-year survival lower than the expected range, through no fault of their own, because of the 95% confidence interval. It is important to realize that each program has its own confidence interval. A defined number does not have to drop out of the curve. Therefore, it is possible for each program to meet expected one-year survival. Small programs typically have a wider range of expected outcomes.
- Delay in reporting: Due to the inherent timeframe of “one-year” survival, the CIBMTR report is delayed by two years because the transplant has to have occurred a year prior, and an additional year is needed to analyze the data. Furthermore, the report uses three years’ worth of data. For example, data analysis may show that a Clinical Program had a particularly bad year in 2012 that resulted in lower-than-expected one-year survival in the 2015 report. However, it is still necessary to review the causes of death and their root causes for the timeframe of the report. If survival is showing an upward trajectory since that year, include that information in the corrective action plan for consideration.
- Overall one-year survival: The CIBMTR report only provides overall one-year survival; however, drilling down into specific diseases will help Clinical Programs determine root causes and which corrective actions may help. This is the same for treatment-related mortality or disease relapse. This type of drill-down has helped programs identify root causes.
- Data errors: Some Clinical Programs have noted that errors in the data submitted to the CIBMTR were the true root of low one-year survival. Indeed, this can affect results of the algorithm. If data errors are a problem, FACT will want to see corrective actions related to accurate data management and reporting.
The FACT Clinical Outcomes Improvement Committee reviews corrective action plans submitted by Clinical Programs not meeting expected one-year survival. Development and review of these corrective action plans is new to Clinical Programs and to FACT. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients, and it appreciates the programs who submitted the first plans and provided more information when requested. 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.
The essential point of these guidelines is to help Clinical Programs write corrective action plans that convey the thought process they employed to identify root causes and implement remedial measures. It is tempting to jump to conclusions and take actions assumed to be beneficial, but those actions will not be effective if incorrect conclusions are made. By providing quantitative data about causes of death, it will be clear to both the program and the FACT committee what the underlying issues are and where opportunities for improvement exist.
FACT will continue to provide advice and examples related to improving clinical outcomes. The next Quality Management Series module is dedicated to Outcome Analysis, and will consist of four webinars from November through February that focus on clinical outcomes. Example corrective action plans, used with permission from Clinical Programs, will also be posted on the FACT website this fall.
FACT continues to celebrate its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. Special events highlighted FACT’s achievements at the 2016 ISCT North America Regional Meeting.
In addition to a successful cellular therapy and cord blood inspection and accreditation workshop, FACT welcomed visitors to an active exhibit booth. Attendees wearing their commemorative FACT 20th anniversary pin received small gifts and were entered in a daily drawing. Day one’s theme was FACT Fortune Friday. Participants received a FACT fortune cookie and registered to win a Logitech Wireless Keyboard. Day two was deemed FACT Saturday School Trivia. Participants answered FACT trivia questions and registered to win an Amazon TV Fire Stick. On day 3, participants enjoyed taking selfies at the booth on Selfie Sunday, and entered to win a Microsoft Band 2 Activity Tracker. FACT thanks everyone who stopped by the exhibit booth and congratulates the lucky winners!
Logitech Wireless Keyboard: Emily Hopewell, Moffitt Cancer Center, Tampa, FL
Amazon TV Fire Stick: Melissa Colon, Moffitt Cancer Center, Tampa, FL
Microsoft Band Activity Tracker: Deborah Lamontagne, Methodist University Hospital, Memphis, TN
FACT also hosted a 20th Anniversary reception at the Peabody Memphis Hotel. Many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and drinks 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. Click on the gallery below to view full-size photos of the celebrations.
Nuevo FACT-JACIE Acreditacion Internacional Webinar
Thursday, October 20, 2016
Únase a nosotros para el primer webinar el 20 de octubre de 2016, a las 9:00 CT (México), 14:00 GMT, 16:00 CET (España). El Dr. Carlos Bachier, Presidente del FACT-JACIE Comité Internacional y Raquel Espada, Coordinadora de Acreditación JACIE, presentarán una visión general del Programa de Acreditación conjunto FACT-JACIE Internacional basado en un enfoque gradual para lograr el cumplimiento con los estándares FACT-JACIE para la Recolección, Procesamiento y Administración de Productos Hematopoyéticos de Terapia Celular.
CBA Webinar: Quality Management for Cord Blood Banks
Wednesday, October 26, 2016
This webinar will be on October 26, at 4:00 PM ET. Robyn Rodwell, PhD, of Queensland Cord Blood Bank at the Mater, will talk about quality management for cord blood banks.
This webinar will be on November 9, 2016, at 11:00 AM ET. Debe Griffin, MS, ASQ CPGP, and John Carpenter, Quality Assurance Manager at Duke University Medical Cord Blood Bank, will discuss how to find, utilize, and keep good quality managers.
Leading by Example: How FACT-Accredited Clinical Programs Continue to Raise the Bar in Quality
Wednesday, November 16, 2016
This webinar will be on November 16, 2016, at 11:00 am ET, and is free-of-charge. Cellular therapy, and healthcare in general, are at the forefront of several initiatives to increase quality in patient care. The blood and marrow transplant field has been a leader in voluntarily improving quality, and new FACT accreditation requirements have been implemented to facilitate real results that have a direct impact on patients. Accredited Clinical Programs are currently adapting to several new standards and procedural changes to the accreditation process, and this free webinar will provide background on these changes. Major topics will include clinical outcomes benchmarking, joint FACT/CIBMTR data audits, and immune effector cell requirements. Dr. Phyllis Warkentin, FACT Chief Medical Officer, and Dr. Helen Heslop, FACT Past President, will explain the rationale for the changes, improvements expected, and details for compliance.
QM Series 7: Benchmarking One-Year Survival
Wednesday, November 30, 2016
This webinar will be on November 30, 2016, at 11:00 ET. Dr. Dennis Gastineau will review the requirements for meeting or exceeding expected one-year survival of HPC transplant recipients. The FACT community will learn a lot together over the coming months, and the presentation will share information such as requirements for corrective action plans, actions that improved one-year survival for programs, and benchmarks for autologous and non-U.S. programs. This is the first webinar in the Quality Management Series, Module 7.
FACT Inspector Workshop for Immune Effector Cells
Friday, December 2, 2016
San Diego, CA
FACT has published draft Standards for programs administering immune effector cells used to elicit 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. 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.
FACT depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. We are excited to announce that we are now accepting inspector applications for our new accreditation service for immune effector cell programs, anticipated to begin in early 2017.
Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements.
This workshop is an important part of the training process. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.
An approved inspector application is required for registration. To apply to become an inspector, submit an online application at http://www.factwebsite.org/Become_An_Inspector/Apply_to_be_a_FACT_Inspector.aspx.
QM Series 7: Completing FACT-Required Outcome Analysis
Wednesday, January 11, 2017
This webinar will be on January 11, 2017, at 11:00 AM ET. Phyllis Warkentin, MD, FACT Chief Medical Officer, will outline the internal outcome analyses required by FACT and provides tips for completing them. Understanding the rationale for these required analyses, and seeing examples from other programs and banks, will help accredited organizations understand and believe in the worthiness of these studies.
QM Series 7: Making Outcome Analysis Work for You
Wednesday, January 25, 2017
This webinar will be on January 25, 2017, at 11:00 AM ET. Dr. George Selby, BMT Program Medical Director at OU Medical Center Blood and Marrow Transplant Program, will describe how to effectively design outcome analyses that provide actionable data. By selecting appropriate variables and collecting adequate information, root cause analyses will not only show what outcomes were, but also offer clues regarding who in your patient population have undesirable trends and why. Asking these questions at the outset of the analysis will make root cause analysis and corrective actions more manageable. This is the 3rd webinar in the QM Series, Module 7: Outcome Analysis.
QM Series 7: Improving Our Clinical Outcomes Virtual Roundtable
Wednesday, February 8, 2017
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.
FACT Cellular Therapy Inspection and Accreditation Workshop
Tuesday, February 21, 2017
This workshop is an opportunity to learn more about the FACT Standards and accreditation process. The agenda will focus on new developments for clinical cellular therapy programs, including clinical outcomes, data management, and immune effector cell programs.
Two tracks will be offered: an applicant track and an inspector track. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.
Cellular Therapy Leadership Course at BMT Tandem- 101
Tuesday, February 21, 2017
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.
Cellular Therapy Advanced Leadership Course at BMT Tandem- 201
Tuesday, February 21, 2017
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.
FACT-ASBMT Quality Boot Camp
Wednesday, February 22, 2017
Join us for the FACT-ASBMT Quality Boot Camp at the 2017 BMT Tandem Meetings on February 22 in Orlando, FL. 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.
NetCord Webinar: Cord Blood Specifications
Wednesday, March 1, 2017
This webinar will take place on March 1, 2017, at 11:00 AM ET. Dr. Gesine Koegler 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.
FACT Cord Blood Inspection and Accreditation Workshop
Tuesday, May 2, 2017
This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will be in attendance to clarify the intent of the 6th Edition NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.