Just the FACTs 2022 Volume 3
Letter from the President
In this month’s newsletter, there are updates regarding Standards from a variety of organizations, including ICCBBA, the United States Food and Drug Administration (FDA), and, of course, FACT. We work diligently to remain aware of and participate in public comment periods to advocate for the benefit of our accredited organizations and partners. I encourage all of you to also submit requested feedback whether as an individual, as part of your healthcare institution, or within your professional activities. The very nature of the FACT community is peer review and input, and it is important to apply this same principle to external organizations whose activities have an impact on our daily work caring for patients.
I also extend my congratulations to King Abdulaziz Medical City – Riyadh, Saudi Arabia for earning FACT accreditation! This is the first cellular therapy accreditation awarded by FACT in Saudi Arabia, and we commend the program for its dedication to achieving this confirmation of quality. FACT continues to offer its support globally to encourage accreditation and quality cellular therapy programs for patients everywhere.
Sincerely,
Catherine Bollard, MD
FACT President
Solicitating Your Opinion! A New ISBT 128 Standard for Chain of Identity (COI) Identifier has been Proposed and Your Input is Requested – Comments Now Due September 13th
Updated on August 19, 2022
ICCBBA, the organization that develops and maintains ISBT 128 coding and labeling technology for products of human origin (including cellular therapy products), has developed a draft standard for a Chain of Identity (COI) identifier. This draft titled, ISBT 128 Standard Chain of Identity (CoI) Identifier – ST-028, is available for public comment until September 13, 2022. This is an extension from the original due date of August 22nd.
ICCBBA introduced this draft standard as the following: “There are circumstances in the collection and processing of cellular therapy products for further manufacture where more than one donation may need to be collected to deliver a specific therapy event. A Chain of Identity (CoI) identifier is needed to link disparate collections that will be used for the same therapy event. At the current time, the CoI identifier is manufacturer-dependent, varies in format between manufacturers, and may not be unique across different manufacturers. To standardize the CoI Identifier, a new ISBT 128 data structure (Data Structure 040) and data element (ChainOfIdentityIdentifier) have been developed utilizing the requirements collaboratively defined by the Standards Coordinating Body for Regenerative Medicine. The specifications for the data structure and data element are defined in the draft ISBT 128 Standard Chain of Identity (CoI) Identifier – ST-028.”
ICCBBA’s Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) and its Standards Committee reviewed the requirements developed by the Standards Coordinating Body and incorporated their comments and suggestions into this draft.
FACT encourages professionals in all areas of cellular therapy product collection, processing, and administration to review the proposed standard and provide comments.
Review the Chain of Identity (COI) Identifier Standard
Submit Comments to ST-028comments@isbt128.org
FDA Publishes Draft Guidance on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
The United States Food and Drug Administration (FDA) is responding to needs for regulatory predictability and leverage of stakeholder efforts for standardization in regenerative medicine therapies, including cellular therapy, via a draft guidance that introduces a voluntary consensus standards recognition program.
Published in June 2022, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Draft Guidance for Industry acknowledges many unique challenges caused by the novelty of regenerative medicine therapy products. The proposed standards recognition program for regenerative medicine therapies (SRP-RMT) is intended to:
- Use agency expertise to evaluate and recognize voluntary consensus standards.
- Provide transparency to industry and other stakeholders regarding CBER’s thinking about a particular method or approach.
- Promote the visibility and use of standards applicable to the agency’s mission.
The draft guidance describes the purpose of the program, procedures for evaluating standards for recognition, documenting the use of a recognized standard, and questions and answers.
Comments on the draft guidance are due by September 14, 2022. Comments may be submitted to https://www.regulations.gov, Docket No. FDA-2022-D-0745-0001.
A public workshop to discuss the guidance will be hosted by the Standards Coordinating Body (SCB) free of charge on August 24, 2022 at 12 pm ET. Register online.
King Abdulaziz Medical City – Riyadh, Saudi Arabia is first Cellular Therapy Program in Saudi Arabia to earn FACT Accreditation
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. 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, MPA
FACT 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 is 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 (TIL) 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 will meet 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.
New Standards Development Manager Reflects on First Year with FACT
By Monique Summers, RN, MSN, MPA
FACT Standards Development Manager
My name is Monique Summers and I am the FACT Standards Development Manager. I joined FACT in March 2021 and have been off and running since day one. I join the FACT team with a nursing, public health, and community health planning background. It has been a pleasure to work with the committees over the past year and I look forward to continuing the process of moving the FACT Standards forward as medical and healthcare technologies advance. As I reflect on my first year with FACT, I am amazed at all the progress that we have made.
In March 2021, we formed the Cord Blood Steering Committee and associated subcommittees to launch the review process for the eighth edition of the Standards. Launching the review of the Cord Blood Standards certainly provided a crash course in all things FACT! I have witnessed first-hand the unrelenting dedication of the committee members to ensure that the Standards reflect the highest level of quality practice in the field of cord blood collection and banking.
Once the work reviewing the Cord Blood Standards was well on its way, I joined the team to finalize the eighth edition HCT Standards for publication. I was able to learn (and sometimes re-learn) the intricate process of preparing a set of Standards for publication. The importance of each department at FACT, including Accreditation, Education, and Compliance, was revealed. The importance of the relationship between FACT and JACIE was also an important concept to learn early and I thank my new colleagues across the pond for your assistance. Every team member stepped up to help guide me through the process to end with a quality set of Standards-related documents. Hundreds of written copies were distributed worldwide, and many more programs have downloaded a free copy from the FACT or JACIE websites.
Following the excitement of publishing the HCT Standards, it was time to refocus on the IEC Standards. The IEC Standards Committee paused its work in response to public comments requesting additional information regarding Tumor Infiltrating Lymphocytes (TILs), seeking to invite additional expertise in TIL therapies to the Standards Committee. We added three physicians to help us incorporate concepts important to the process of collecting and manufacturing tissues for these important therapies. The work from this group is underway with plans to publish the second edition in early 2023.
Last September, the public was given the opportunity to submit comments on the third edition of Common Standards. I joined the process following receipt of those comments and worked with the Steering Committee to finalize the Common Standards. We are actively working to prepare this document for final publication with an anticipated release date in August 2022.
The COVID-19 pandemic has changed the way that healthcare is approached all around the world. FACT has not been immune. We have thrived using the virtual meeting process to continue to meet the needs of our accredited programs while working to improve the Standards. We have learned together via our online workshops and boot camps. When possible, we have gathered in person, including during the recent ISCT Annual Meeting in San Francisco, California. I look forward to continuing to work and learn with each of you in the upcoming years. If you ever have any questions or if I can be of assistance in any way, please don’t hesitate to reach out at monique.summers@factglobal.org.
World Marrow Donor Day to be Celebrated Worldwide on September 17th
The World Marrow Donor Association (WMDA), a global association of blood stem cell, marrow, and/or cord blood registries or organizations representing over 40 million blood stem cell donors from 55 different countries (https://statistics.wmda.info/), announces the celebration of the 8th World Marrow Donor Day (WMDD) on September 17, 2022. Following the past seven years of successful celebrations of this special day, the world again will come together on the third Saturday of September. The primary purpose is to thank all donors and highlight global cooperation in blood stem cell transplantation.
“The World Marrow Donor Association was established 28 years ago to ensure that donations of stem cells by altruistic volunteers could find their way to the patients who needed them, independent of geography and politics. World Marrow Donor Day is the embodiment of the value, respect and indeed love we in the transplantation community (and particularly the patients suffering from life-threatening diseases and their families) offer to our donors. It is only one day but it reflects what we think year-round in a concentrated way.” – Jeff Szer, Past President of the WMDA.
Background
Since the first bone marrow transplant performed in the 1950s, over a million patients have received a transplant of blood stem cells for the treatment of a wide variety of blood cancers and other diseases of the blood and bone marrow. Often, transplantation using healthy cells from a donor or cord blood unit may be the only chance of cure. When there is no suitable donor within the family, an unrelated donor, who could be from a completely different part of the world, may be the best match for the patient. The WMDA’s global network of organizations makes cooperation and a global exchange of information possible. This strong collaboration has helped hundreds of thousands of patients internationally.
FACT plans to participate in this special day to honor the donors that have saved lives around the world. We encourage our accredited organizations to also celebrate World Marrow Donor Day to express their appreciation. See https://worldmarrowdonorday.org/stories/ for patient and donor stories.
About World Marrow Donor Association (WMDA)
Worldwide, over 50,000 patients per year are looking for a matched donor outside their family. About 50% of the patients that find a donor find his or her perfectly matched donor in another country. WMDA works towards a global standardization by establishing an accreditation program for organizations that provide blood stem cells for patients in need of a transplant. The accreditation program ensures the welfare of the donors and high-quality stem cells for patients worldwide.
To learn more about WMDD or WMDA, visit their websites: www.worldmarrowdonorday.org or www.wmda.info.
ASTCT Announces Clinical Education Conference for APPs, Nurses, Fellows, and Trainees
The ASTCT Clinical Education Conference, in Orlando, Florida, from October 13-15, will include educational tracks on the foundations of bone marrow transplantation (BMT), adult care, and pediatric care. There will also be exhibitors and product demonstrations.
The event is open to APPs, nurses, trainees, and fellows, and offers 16.5 hours of ACCME and ANCC continuing education. These hours can also be applied to FACT requirements for continuing education.
Join ASTCT (ASTCT members save 50 USD on registration)
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.
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.
Upcoming Online Sessions for Quality and IEC Webinar Series
Join us for two upcoming webinars that will discuss hot topics in cellular therapy! FACT is currently offering two series of webinars. One is Module 11 of the QM Series focusing on corrective action plans, and the other is a new series on Immune Effector Cells. The following webinars are the next ones offered for each of these series. Register online today!
FACT Quality Management Series 11: Implement and Assess Effectiveness of Corrective Action Plans
August 24, 2022 at 11 am ET
Folashade Otegbeye MBChB, MPH from the Cellular Processing Facility at Fred Hutchinson Cancer Research Center in Seattle and Kerri Hill BSN, RN from the UAMS Cancer Institute in Little Rock will discuss the following:
1. Implementation of corrective action plans.
2. Monitoring corrective action plans.
3. Assessing the effectiveness of a corrective action plan.
FACT Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors: General Concepts and Need for Harmonization of Standards
September 28, 2022 at 11 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 Ohio Health Blood and Marrow Transplant and Cellular Therapy Program and Sarah Nikiforow, MD, PhD, from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will:
1. Discuss unique challenges and considerations in IEC manufacturing.
2. List subtypes of IECs in solid tumors including TILs, CAR-T cells, and TCRs.
3. Examine the need for quality standards.
Cord Blood Inspector Trainees Invited to FACT Inspector Training Course in Miami
FACT invites you to join us for a Cord Blood Inspector Inspector Training Course in conjunction with the 2022 Cord Blood Connect Meeting in Miami Beach, Florida. We are pleased to welcome you on Thursday, September 8, 2022, from 8:00 am – 5:00 pm at the Loews Miami Beach Hotel.
The purpose of this FACT inspector training course is to train cord blood inspector trainees. The course is designed to guide the trainee through the inspection experience from accepting an inspection assignment, submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.
In preparation for the FACT inspector training course, we ask that you complete a few workshop prerequisites. Preparing for the inspector training session in advance will help you to become more familiar with the FACT Standards and the accreditation process. Also, it will give you a small sense of what it is like to prepare for an actual FACT inspection. Once you have registered for the training course, you will receive an email with the prerequisites.
Interested in becoming a FACT Inspector? Apply to train as an inspector!
Register for the Cord Blood Inspector Training Course
