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FACT Update  September 2022

                       

Mikaela VanMoorleghem, MPA, Education and Training Coordinator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA

OMAHA, Neb. – King Abdulaziz Medical City – Riyadh, Saudi Arabia received internationally recognized accreditation by FACT. Directed by Mohsen Alzahrani, MD, it is the first and only cellular therapy program in Saudi Arabia to be recognized by FACT.  The program received accreditation on July 1, 2022 and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.

“The FACT accreditation process has been a long and exciting journey with a significant learning experience. Our entire transplant team, with the help from the hospital’s multidisciplinary support services, worked tirelessly to make this major achievement possible. It is a great privilege to hold the distinction of being the very first institution in Saudi Arabia and the region to be awarded FACT accreditation. This remarkable achievement demonstrates clinical excellence, spirit of teamwork, collaboration, professional commitment, and administrative support,” stated Dr. Alzahrani. “It is our belief that FACT Accreditation will make our colleagues and patients aware of our facility's commitment to providing the best possible care for cellular therapy and that we are committed to uphold the highest possible standards of care.”

Dr. Mohsen Alzahrani, MD

Dr. Phyllis Warkentin

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Achievement of FACT accreditation requires dedication and perseverance, and demonstrates that Dr. Mohsen Alzahrani and staff have established a high-quality program in hematopoietic cellular therapy and transplantation.  I congratulate these leaders in the region on this accomplishment.”

Standards Development Updates
By Monique Summers, RN, MSN, MPAFACT Standards Development Manager

Standards Committee members have risen to the challenges of COVID-19 over the past two years, and all four sets of FACT Standards have been in the active phase of the review process.  Members have incorporated feedback from constituents, discussed new developments in cellular therapy, and edited drafts. Updates for each set of Standards are provided below. As progress continues, important updates will be announced.

FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition

FACT and JACIE finalized the eighth edition Hematopoietic Cellular Therapy Standards in August 2021 with a revision in December 2021.  These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, cord blood, or other tissues and administered by a blood and marrow transplant (BMT) team.

The FACT Accreditation Services department is working with accredited and applicant programs that are beginning the accreditation process under the eighth edition and are available for questions.

FACT Standards for Immune Effector Cells, Draft Second Edition

The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy.  To ensure that the Standards reflect emerging changes in the field, FACT delayed the publication of the second edition to incorporate the expertise of providers with Tumor Infiltrating Lymphocyte (TILs) experience.  The committee has resumed its work and plans to publish the draft for a second public comment period in late 2022.

FACT Common Standards for Cellular Therapies, Draft Third Edition

The draft third edition FACT Common Standards for Cellular Therapies was published in 2021 for public comment. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy.  This includes HPC transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. The third edition is scheduled to be published soon.

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Draft Eighth Edition

The Steering Committee kicked off the drafting of the eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in May 2021, and subcommittees have been meeting for the past year.  The Steering Committee met during the 2022 Cord Blood Connect meeting in Miami, Florida to complete a final review of the draft prior to public comment, which is scheduled for late 2022.

Transforming Data into Knowledge: How Sarah Cannon Analyzes Risk-Adjusted and Unadjusted Survival Outcome Trends and Projections

By Therese Dodd, BA, MBA, RN, CPHQ, FNAHQ
Quality and Accreditation/Regulatory Compliance Specialist
Transplant & Cellular Therapy Network
Sarah Cannon
1100 Dr. Martin L. King, Jr. Blvd, Suite 800, Nashville, TN 37203

The centers of Sarah Cannon Transplant & Cellular Therapy Network (SCTCTN) are not alone in their need to understand clinical outcomes, the definitive outcome being patient survival. It falls to the centers to transform an abundance of data into knowledge for performance improvement.

The Center for International Blood & Marrow Transplant Research (CIBMTR®) Transplant Center-Specific Survival Report provides survival data to eligible hematopoietic cell therapy (HCT) centers for first allogeneic transplants for a three-year period to at the end of each calendar year. The report displays a “–1” in the performance status column for centers whose actual survival is lower than the 95% confidence limits for predicted survival, a “1” if performing above the confidence limit, and a “0” if performing as predicted. The SCTCTN centers recognized that reading the report is just a first step. One challenge to understanding the survival results is that these reports only display the information from preceding years as a table (see example in Figure 1). Supplying information to centers in this manner may provide them a false sense of confidence if they do not trend the specific outcomes results.  In the figure 1 example, the “-1” assigned in the 2015 report may have been an unpleasant surprise if the center wasn’t rigorously analyzing its clinical outcomes internally. 

Figure 1.

The SCTCTN centers have created box graphs, similar to the Excel template available on the FACT website in the Clinical Outcomes Resource Center, to track the clinical outcomes from the CIBMTR® Transplant Center-Specific Survival Report .  As can be seen in Figure 2, there was a decline in actual % 1 year survival for transplants performed during 2010-12, dropping from greater than the % predicted survival in the previous report to lower than % predicted survival and approaching the lower limit of the 95% confidence interval.

With the 2011-13 report, the 95% confidence interval increased, which indicates lower-risk patients were transplanted.  Since the report is risk-adjusted, there was an expectation that patient survival would increase; however, the % actual survival was worse than the lower limit of the 95% confidence interval.   Fortunately, the center had already started root cause analysis and identified several opportunities for improvement including, but not limited to, increasing data abstraction and entry accuracy, strengthening survivorship programs, and expanding caregiver support services.  The center was able to improve its clinical outcomes by the time of the subsequent report.  

Figure 2.

In addition to tracking data from the CIBMTR® Transplant Center-Specific Survival Report, the SCTCTN have overlaid a trend line to the box graphs (see black dotted line in Figure 2) of actual % survival using data from the CIBMTR® enhanced data back to centers (eDBtC).  Based on experience, and not surprisingly, SCTCTN centers determined that the eDBtC % actual survival for first allogeneic transplants tracked closely to the CIBMTR® report data year over year. Because of this, the centers can determine an estimate that is prognostic for the actual % survival in the upcoming report by finding the % survival at 12 months using the CIBMTR® eDBtC “Survival Probability – HCT” functionality (see Figure 3). 

Figure 3.

In addition to annual analysis of the CIBMTR® Transplant Center-Specific Survival Report, the SCTCTN centers monitor actual autologous and allogeneic hematopoietic cell transplant (HCT) % 30-day, 100-day, and 1-year survival and treatment-related mortality in smaller timeframe cohorts on a quarterly basis and more concurrently.  Tracking these data (as well as many other quality and outcome metrics) supports rigorous quality management programs that improve the experience for SCTCTN patients.

FACT Cord Blood Inspector Training Course Was a Success!

FACT hosted an inspector training courses for cord blood trainees at Cord Blood Connect 2022.  Inspector trainees spent time with experienced FACT cord blood inspectors examining documents that can be reviewed in advanced of the inspection, viewing a video tour of a cord blood bank, and assessing facility documents and a cord blood unit record. At the end of the day, trainees were able to ask questions to our expert panel. 

FACT is so grateful for our most valuable asset, volunteer inspectors. We truly appreciate your contribution of expertise and time to the field of cord blood banking. Watch some of our cord blood inspectors in action at the Cord Blood Connect Meeting! https://www.youtube.com/embed/OKJJ6Wi9Av0

FACT is Seeking Cord Blood Inspectors!

FACT invites you to serve as an inspector and help accredited organizations provide patients the best care possible. Possibly the greatest benefit of serving as an inspector is the opportunity to give back to the field of cellular therapy, but there are so many other value-added benefits to consider including:

Exposure to Exemplary Practices
Inspectors have the opportunity to observe how other cord blood banks meet FACT Standards. Inspectors bring back new ideas from banks inspected and interactions with experts on inspection teams. Evidence shows that accredited organizations without an inspector have more difficulty complying with current standards.

Free Access to FACT Educational Resources
Volunteer inspectors have free access to both in-person and online educational events with an annual value of $1,840.

Contributions to Standards Development
Cord blood banks with inspectors on their staff have greater opportunities to contribute to the development of FACT Standards. The opinions of FACT inspectors are always sought early in the process of developing new editions of standards and accreditation requirements. Eligibility of key FACT committees also requires that members be, or have been, a FACT inspector.

Information about qualifications and how to apply to become a FACT inspector can be found here or under the "Inspectors" tab on the FACT website. If you have any questions, please contact FACT Education Coordinator, Mikaela VanMoorleghem, or the FACT office. We hope you will consider serving as a FACT inspector.

Upcoming FACT Webinars

IEC Therapy for the Treatment of Solid Tumors Webinar:

General Concepts and Need for Harmonization of Standards
Wednesday, September 28, 2022 | 11:00 am ET

This webinar offers an introduction to Immune Effector Cellular (IEC) Therapy for the treatment of solid tumors. Basem William, MD, MRCP, FACP from the OhioHealth Blood and Marrow Transplant and Cellular Therapy Program and Sarah Nikiforow, MD, PhD from the Dana-Farber Cancer Institute Cell Manipulation Core Facility in Boston will discuss unique challenges and considerations in IEC manufacturing; list subtypes of IECs in solid tumors including TILs, CAR-T cells, and TCRs, and examine the need for quality standards.

At the end of the webinar, participants will have the opportunity to ask Dr. William and
Dr. Nikiforow questions during the live Q&A portion.
Register Now!

Quality Management Series 11 Webinar:

Program Perspective
Wednesday, November 9, 2022 | 4:00 pm ET

A corrective action plan (CAP) is an important quality management tool for any program. A CAP is a method of documenting non-compliance issues, identifying their root causes, and capturing measurable, achievable solutions and realistic deadlines. Join John McCarty, MD from the VCU Health Cellular Immunotherapies and Transplant Program and Phillip Johnson MMedSc(Path) from the Queensland Cord Blood Bank at the Mater as they discuss developing, implementing, monitoring, and assessing a CAP from their program's perspective.

At the end of the webinar, participants will have the opportunity to ask Dr. McCarty and Dr. Johnson questions during the live Q&A portion.
Register Now!

IEC Therapy for the Treatment of Solid Tumors Webinar:

Tumor Infiltrating Lymphocytes
Tuesday, January 17, 2023 | 11:00 am ET

Tumour-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.

Presenters include:

• Parameswaran Hari, MD, MRCP, DRCPath, MS, from Iovance Biotherapeutics
• John Mullinax, MD, from H. Lee Moffitt Cancer Center & Research Institute Blood and Marrow

Register Now!