Just the FACTs 2022 Volume 6
Letter from the President
With the closing of 2022, I, and the FACT Board of Directors, reflected on accomplishments achieved this year and the impact those accomplishments will have in the coming year. FACT is pleased with the tremendous progress we have made to further advance our mission well into the future.
In 2022, following the transition to independent status, after a 25-year partnership with the University of Nebraska Medical Center, FACT welcomed many new faces to its international headquarters and developed a strategic plan for the next three years. We are excited to share our plans to strengthen our existing services and leverage our expertise to serve unmet needs. Both of these are necessary to meet the unprecedented demand for cellular therapies from cancer and beyond. This is going to be extremely critical as more cell therapies obtain licensure and is particularly topical this month when Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) receives European Commission approval “as the first ever therapy for adults and children with EBV+ PTLD”.
In addition, I hope you will see in this newsletter an important announcement regarding the online accreditation portal. We are eager to implement a major upgrade in February to better serve our accredited programs and volunteer inspectors.
Thank you so much for another year rising to the challenge to offer care to an ever-increasing number of people in need. FACT is so proud to participate in efforts to increase the quality of and access to cellular therapy in terms of geography, resources, and indications. None of this would be possible without you.
Sending you all heartfelt thanks and wishing you a very happy time over the holidays and looking forward to exciting times ahead in 2023!
Cheers!
Cath
Catherine M. Bollard, MD
FACT President
A New Version of FACT’s Accreditation Portal is Coming!
It’s here! Mark your calendars for the upcoming launch of a major FACT Accreditation Portal upgrade. The portal will be inaccessible during the upgrade from January 28-31. Effective February 1, 2023, the new version will be available to all users to access their current applications and reports. If you have any applications or reports due, please complete these prior to January 27.
FACT has prepared new user How-To Guides to assist in navigating the upgraded portal’s new features. Your username and password will not change. Your Accreditation Coordinator is a valuable resource for any questions.
FACT will be communicating individually with those applicants and inspectors who will be most impacted.
Applicants with Open Applications or Reports
For our applicants who are currently working on an application/report or will begin working on an application/report prior to the launch window, all data will be retained and transitioned over to the new version. Your upgraded application/report will be available for you to complete on February 1, 2023.
If you have already completed your compliance application and are waiting for your inspection to be scheduled, your application will be transferred and your Accreditation Coordinator will verify that the transfer was accurate.
Accreditation Portal Open House
To help with transitioning to the upgraded portal, FACT will host an Accreditation Portal Open House at the 2023 ASTCT Tandem Meetings in Orlando, Florida. FACT’s Director of IT Services will demonstrate the new features in an open forum on Thursday and Friday, February 16 and 17, 2023. Additional information including times and location will be announced. You are invited to ask questions and experience the new system.
FACT Updates its Clinical Outcomes Corrective Action Plan Policy for Transplant Programs
Clinical transplant programs accredited under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration have always been expected to follow and evaluate clinical outcomes of transplantation, including both individual and aggregate data. Since the sixth edition in 2015, Standards have also required that clinical outcomes be assessed against national or international outcome data, that program outcomes should meet or exceed national or international benchmarks, and that programs not meeting the expected range of survival must submit to FACT a corrective action plan (CAP).
In the United States, all allogeneic hematopoietic transplants must be reported to the CIBMTR. Since 2016, the current FACT process for review of clinical outcomes requires that Clinical Programs performing allogeneic transplants must meet the expected range of one-year survival as published in the CIBMTR Transplant Center-Specific Survival Report. If the one-year survival for first allogeneic transplants falls below the risk-adjusted expected range, the program must submit a CAP that is reviewed by the FACT Clinical Outcomes Improvement Committee. The Committee advises the Clinical Program, monitors implementation of the elements of the CAP, and follows the program’s internal data assessing the effectiveness of the CAP and improvements in survival.
The CIBMTR report published in December 2021 included first allogeneic transplants for the years 2017-2019. This was the first report in which all included years were within a timeframe in which the Clinical Outcomes Improvement Committee had been requesting and reviewing CAPs. This report presented an opportunity to evaluate the effectiveness of the Committee’s processes. The Committee reviewed data collated from CIBMTR reports, internal data submitted by Clinical Programs, and Committee determinations on the appropriateness and effectiveness of CAPs. It determined that the likelihood that a CAP will successfully improve one-year survival can be predicted by the duration of time in which the program’s risk-adjusted one-year survival was below the expected range, trends in survival rates based on the program’s internal data, and the ability and effort demonstrated by the program.
Based on this analysis, the FACT Board of Directors approved additional steps added to the Clinical Outcomes Corrective Action Plan Policy which include:
- If the risk-adjusted one-year survival remains lower than the expected range and does not improve for three consecutive reporting years, the Clinical Outcomes Improvement Committee will formally evaluate in more depth the Clinical Program’s ability and effort to improve survival.
- The Committee may determine that ability and effort are sufficient, that more time is required to demonstrate the required improvement, and/or that other contingencies exist.
- If the Committee determines that the program has not demonstrated sufficient ability or effort, the program’s accreditation will be placed on probation. Probation is defined as a period of time during which a program has not met specific defined criteria and is at risk of losing FACT accreditation if additional requirements are not met. This status is documented in the program’s FACT application report and internal FACT records but is confidential and will not be published or released.
- Programs on probation for clinical outcomes remain accredited but may be required to complete a focused reinspection. The scope of the reinspection will be based on the program’s specific deficiencies in evaluating and improving one-year survival. It is our experience that the intensified support provided by the Committee during the reinspection process leads to sustained improvement in survival.
- The timing of the focused reinspection will be determined by the Committee, independent of the program’s normal accreditation cycle.
- If the program does not demonstrate satisfactory correction of the deficiencies, the program’s accreditation may be suspended in accordance with FACT’s policy on Suspension or Termination of Accreditation. The Committee will determine the timeframe in which deficiencies must be corrected and one-year survival must improve. Failure to demonstrate correction of the deficiencies within the established timeframe may result in termination of the accreditation.
We note that the potential for accreditation suspension has always been a possible consequence for low one-year survival as published in the current version of the Clinical Outcomes Corrective Action Plan Policy; however, these changes provide a framework based on data in which the Clinical Outcomes Improvement Committee can formally make such a decision. The ultimate goal of FACT and Clinical Programs throughout this process is to improve outcomes for patients. We believe this process will improve patient survival.
For more details about the CIBMTR Transplant Center-Specific Survival Report, see the article published in November 2022 at https://news.factglobal.org/from-the-archives-understanding-the-cibmtr-outcomes-reports/.
FACT is Proud to Partner with Advanced Therapies Week – FACT Readers Offered 15% Off Registration Fee
We are proud to announce our partnership with Advanced Therapies Week. Taking place between January 17-20, 2023 at the Miami Beach Convention Center, this is an event like no other. With networking opportunities scheduled from morning to night, Advanced Therapies Week connects industry leaders to share ideas and insights while building meaningful connections and partnerships to make a difference. It’s the place to be!
FACT registrants are offered a 15% discount off the registration fee. To take advantage of this discount, use the code “FACT15” during online registration.
Learn More about Advanced Therapies Week
View the Agenda
Register (Remember to use the discount code FACT15!)
Join the 2023 FACT Education Tour!
As the new year approaches, so does our upcoming tour of educational events! We are excited to see you in person or virtually. The following is a list of locations and sessions – which stop will you join?
Register for the FACT Cellular Therapy Accreditation Workshop!
We invite you to attend the Cellular Therapy Accreditation Workshop in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s Accreditation Workshops make learning about the accreditation process and related Standards an up-close and personal experience. Accreditation Workshops are collaborative events where you will be able to work through a series of scenario-based case studies supplemented with presentations facilitated by experienced FACT instructors.
The Cellular Therapy Accreditation Workshop provides a high-level overview of topics including requirements and expectations for accreditation, how to position your organization to pursue accreditation, and the most commonly cited Standards. Additional areas of discussion include manufacturer audits and corrective action plans and audits to improve outcomes and data management.
FACT Clinical Inspector Training Course
We invite you to attend the FACT Clinical Inspector Training Course in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s Inspector Training Courses make learning about the inspection process an up-close and personal experience with practical, hands-on sessions simulating performing an inspection supplemented with presentations facilitated by experienced FACT inspectors.
The FACT Inspector Training Course is for clinical inspector trainees only. Trainees must complete all pre-training course requirements before attending. The training course is a collaborative event where the trainee will work with an experienced FACT inspector to review the entire inspection process from beginning to end.
FACT instructors will educate inspector trainees on the following topics during the inspector training course:
- Inspection preparation essentials
- Important technology tools
- Advance review of documents
- Clinical program tour
- Facility documents
- Patient record review
- Post-inspection requirements
If you are interested in training as a FACT inspector, please contact Suzanne Birnley at suzanne.birnley@factglobal.org or visit https://www.factglobal.org/inspectors/.
Register for the FACT – ASTCT Quality Boot Camp!
We invite you to attend the FACT – ASTCT Quality Boot Camp on Wednesday, February 15, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, FL. This is a collaborative event where you will participate in a series of roundtable activities supplemented with presentations facilitated by experienced FACT inspectors and quality personnel.
The theme of the FACT – ASTCT Quality Boot Camp is: Strengthen your Quality Management Program through the Effective Use of Quality Tools. Using the right quality tool can help reduce errors, improve communication, help maintain compliance, and save programs time and resources while improving the overall quality of your program and processes.
During the quality boot camp, FACT instructors will discuss tools and techniques most commonly used in quality management and process improvement including:
- SWOT Analysis (Strengths, Weaknesses, Opportunities, and Threats)
- Risk Assessment and Failure Mode and Effects Analysis (FMEA)
- The Five Whys
- Fishbone/Ishikawa Diagram
If you cannot join us in Orlando, future stops include:
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FACT Virtual Apheresis Collection and Processing Accreditation WorkshopVirtual, Wednesday, April 19, 2023 8:00 am – 5:00 pm CT Book your ticket now! |
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FACT Apheresis Collection Inspector Training CourseMinneapolis, MN April 2023 8:00 am – 5:00 pm CT Book your ticket now! |
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FACT Cord Blood Accreditation WorkshopParis, France, May 30, 2023 8:00 am – 5:00 pm CT Book your ticket now! |
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FACT Cord Blood Inspector Training CourseParis, France, May 30, 2023 8:00 am – 5:00 pm CT Book your ticket now! |
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FACT Collection, Processing, and Cord Blood Virtual Quality Boot CampVirtual, June 23, 2023 8:00 am – 5:00 pm Book your ticket now! |
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FACT Accreditation and Quality Principles WorkshopPerth, Australia, August 7, 2023 8:00 am – 5:00 pm Registration Open Soon! |
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FACT Processing Inspector Training CourseHouston, TX, September 7, 2023 8:00 am – 5:00 pm Book your ticket now! |
FACT’s IEC Webinar Series Continues in January 2023
Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors Webinar:
Tumor Infiltrating Lymphocytes
Tuesday, January 17, 2023, | 11:00 am ET
Tumor-infiltrating lymphocytes (TILs) can recognize and kill cancer cells. This webinar will provide a broad introduction to TILs and a review of current clinical experience and unique considerations in TIL manufacturing. Presenters will also discuss the need for establishing safety and efficacy quality benchmarks for TILs.
Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors Webinar:
CAR-T cells and T-cell Receptor Cells in Solid Tumors
Thursday, March 30, 2023, | 11:00 am ET
CAR-T and TCR cell therapy has demonstrated encouraging potential for the treatment of solid tumors. During this webinar, presenters will highlight current clinical experience with CAR-T cells in solid tumors and unique considerations in manufacturing. Presenters will also discuss the need for establishing safety and efficacy quality benchmarks for CAR-T cells and TCRs.
