Just the FACTs 2025 Volume 2
President’s Letter
Greetings!
I am happy to report that FACT has so much to celebrate! In this newsletter, we highlight our appreciable progress in catching up on accreditation inspections following the delays related to the COVID-19 pandemic. An enormous thanks to all our volunteer inspectors, our accredited programs, and our headquarters staff for your dedication and flexibility toward making this happen. David Schmahl (FACT Chief Executive Officer), and the entire FACT team, are committed to resolving the backlog and operating within established accreditation timelines to bring stability to our already accredited programs and to rapidly accredit new programs that we are expecting in the coming year.
We also excitedly announce that FACT’s Chief Medical Officer, Dr. Phyllis Warkentin, and many other FACT leaders were honored at the Tandem Meetings in Honolulu this year. With so many FACT volunteers achieving honorific recognition, the deep involvement of the medical community in the establishment of FACT Standards and the inspection of programs is underscored. I therefore send my sincerest congratulations to all of the recipients!
Also from Tandem, I am delighted to report that the FACT Education Committee and FACT staff members hosted extremely popular and highly successful events. In particular, the Quality Boot Camp, Accreditation Workshop, and Inspector Training were attended by hundreds of people and received rave reviews. To those who organized, led, and/or participated in these events, a huge thank you!
Finally, in this newsletter, we highlight the importance of teamwork between our accredited programs and third-party manufacturers providing research or commercial cellular therapy products, specifically related to written agreements and vendor qualification. All of these entities are working tirelessly to onboard new products and network sites so that more eligible patients have access to new cell-based therapies. We recognize that, as leaders in this new frontier of medicine, it is challenging and requires a lot of coordination and negotiation. We aim to work with everyone involved in a collaborative manner to pave the way for more and more quality options for the patients we serve.
On that celebratory note, I want to express my profound gratitude to you all for your continued commitment and dedication to realizing FACT’s mission “. . . to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.”
Sincerely,
Cath
Catherine Bollard, MD
FACT President
FACT Accreditation Makes Tremendous Progress Against the COVID-19 Backlog
By Andrea Carney, MLS(ASCP)cm, FACT Accreditation Coordinator
FACT is ringing in 2025 with a remarkable achievement, having awarded a record number of program accreditations in January. This milestone underscores the tireless work of FACT staff and dedicated volunteers, who have worked diligently to address the backlog of inspections caused by the COVID-19 pandemic. This backlog had previously delayed inspections, but thanks to the collaborative effort between FACT’s team and volunteer inspectors, the organization has made significant strides in resolving this issue.
A large number of inspections were carried out in November, marking a turning point in the progress toward catching up on these important evaluations. The influx of new and experienced volunteer inspectors played a crucial role in making this possible, allowing FACT to grant renewal and initial accreditation to 20 organizations in January alone. This surge in accreditation represents a significant leap forward, both in the organization’s ability to meet its goals and in ensuring that high-quality standards are upheld in the field of cellular therapy.
Accreditation is not just a formality; it is a rigorous and thorough process that involves a comprehensive review of various facets of operation. These include an analysis of the program’s policies and procedures, a detailed assessment of clinical outcomes, and an examination of data reporting practices. The process also includes an on-site inspection, where evaluators assess the real-world application of the program’s practices to ensure alignment with the Standards. It is through this meticulous process that FACT ensures that accredited programs are consistently delivering the best possible care.
This record-breaking achievement of 20 renewal and initial accreditations in one month is not just a number. It is a testament to FACT’s ongoing commitment to continuously improving cellular therapy, even in the face of challenges. It demonstrates a consistency and adaptability that is critical in such a fast-evolving field.
Looking ahead, FACT remains dedicated to its ongoing mitigation efforts to address the COVID-19 backlog. The organization has set its sights on bringing its accreditation process fully up to date, with plans to be current on all inspections and accreditations by the end of the calendar year. This commitment not only reinforces FACT’s dedication to excellence but also sets the stage for continued success in the years to come.
In celebrating this milestone, FACT reflects on the hard work and collaboration that made it possible. The involvement of volunteers, the expertise of staff, and the support of accredited organizations all played essential roles in making January’s achievements a reality. Moving forward, FACT is excited about the future and is committed to continuing its track record of on-time accreditation.
As 2025 progresses, FACT looks forward to further expanding its impact, continuing its work with both new and returning volunteers, and celebrating more successes. The future of the organization is bright, and its ability to adapt and innovate will continue to drive its success in ensuring the highest levels of care and practice in this vital medical field.
PRESS RELEASE: Shandong Qilu Stem Cell Engineering Co., Ltd. is first Cord Blood Bank in Mainland China to earn FACT Accreditation
FOR IMMEDIATE RELEASE
March 3, 2025
Shandong Qilu Stem Cell Engineering Co., Ltd. is first Cord Blood Bank in Mainland China to earn FACT Accreditation
OMAHA, Neb. – Shandong Qilu Stem Cell Engineering Co., Ltd. (Shandong CBB) in Jinan City, Shandong, China, achieved internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT), on February 18, 2025. Shandong CBB is the first and only cord blood bank in mainland China to receive this recognition. Under the leadership of Baijun Shen, MD, the bank has demonstrated its commitment to quality by meeting FACT’s Standards for cord blood collection, banking, and release for administration of both unrelated and related donations.
A spokesperson for Shandong CBB notes, “FACT accreditation represents a rigorous validation of our commitment to global standards of excellence in cellular therapy and cord blood banking. This achievement not only elevates the quality of healthcare services in China but also strengthens international trust in our capabilities. The accreditation process was a transformative journey for our team, reinforcing the importance of collaboration, precision, and continuous improvement. We hope this milestone inspires further advancements in the field across the region.”
With FACT-NetCord accreditation, Shandong CBB demonstrates its commitment to meeting the highest international standards in the field of cord blood banking.
Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Achievement of accreditation by FACT is a significant accomplishment for the Shandong Qilu Stem Cell Engineering Co., Ltd., of Jinan City, the first Cord Blood Bank in mainland China to reach this milestone. Through this accreditation, Dr. Zhonghua Chu, Cord Blood Bank Director, Dr. Baijun Shen, and the staff at the Cord Blood Bank and Processing Facility, in conjunction with numerous collaborating hospitals that provide cell collections have demonstrated their dedication, resilience, and commitment to providing high quality products for the patients they serve. FACT recognizes this important accomplishment and the leadership of the Shandong Qilu Stem Cell Engineering Co., Ltd., in the field and the region.”
The Foundation for the Accreditation of Cellular Therapy (FACT) establishes and promotes high-quality standards for cellular therapy and cord blood banking worldwide.
About FACT
Founded in 1996, FACT establishes standards for high quality patient care and laboratory practice in cellular therapies and regenerative medicine. FACT is a non-profit corporation co-founded by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for the voluntary inspection and accreditation in the field of cellular therapy. FACT promotes improvement and progress by establishing minimum standards, providing education, and inspecting and accrediting programs worldwide. For more information, visit www.factglobal.org.
Media Contact
fact@factglobal.org
402-920-7001
FACT Chief Medical Officer Dr. Phyllis I. Warkentin and Other FACT Leaders Granted ASTCT Fellow Designation
Congratulations to Dr. Phyllis I. Warkentin, FACT CMO, and many other FACT leaders for being recognized as an ASTCT Fellow at the 2025 Tandem Meetings in Honolulu, Hawaii!
Per the ASTCT website, FASTCT designation honors exceptional achievement and service within the member community. This distinction recognizes ASTCT members for their volunteer service, dedication, and commitment to ASTCT. Recipients have carried out efforts that benefit ASTCT, the specialty of transplantation and cellular therapy, and the patients whom they serve.
Congratulations to all of the following individuals who were recognized as ASTCT Fellows this year:
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- Corey Cutler, Dana-Farber Cancer Institute
- Frederick Appelbaum, Fred Hutchinson Cancer Center
- Bruce Blazar, University of Minnesota
- Christopher Bredeson, The Ottawa Hospital
- Morton Cowan, University of California San Francisco School of Medicine and UCSF Benioff Children’s Hospital
- Maria Ginocchio, Children’s Hospital Colorado
- Rebecca Gonzalez, H. Lee Moffitt Cancer Center and Research Institute
- Joanne Kurtzberg, Duke University
- Margaret MacMillan, University of Minnesota
- David Porter, The University of Pennsylvania
- Jerome Ritz, Harvard Medical School
- Jean Sanders, Fred Hutchinson Cancer Research Center
- Kim Schmit-Pokorny, Nebraska Medicine
- Rainer Storb, University of Washington School of Medicine
- Phyllis I. Warkentin, Foundation for the Accreditation of Cellular Therapy and University of Nebraska Medical Center (FACT Chief Medical Officer)
FACT Kicks Off the 2025 Education Season in Honolulu
FACT launched the 2025 education season with a series of annual events ahead of the Tandem Meetings in Honolulu, Hawaii. These events included the Quality Boot Camp, Cellular Therapy Accreditation Workshop, and Clinical Inspector Training Course, bringing together over 250 participants from around the world!
This year marked a special milestone—the 10th Annual Quality Boot Camp. Co-hosts Dr. Kimberly Kasow, Chair of the Quality Management Committee, and Phillip Johnson, Vice-Chair of the Quality Management Committee, and current FACT Board Member, reflected on the program’s evolution over the past decade. Themed around audits and outcomes, this year’s Boot Camp featured engaging lectures, interactive Q&A sessions, and roundtable discussions facilitated by experienced quality professionals. These sessions provided attendees with the opportunity to exchange insights, network with peers, and explore real-world challenges in quality management. The energy in the room remained high until the very end!
The Accreditation Workshop attracted new applicants beginning their accreditation journey and representatives from accredited organizations seeking to refine their processes. Led by Dr. Donna Salzman, a member of FACT’s Inspector Development Committee, the workshop featured presentations from FACT’s accreditation experts, including Dr. Phyllis I. Warkentin, FACT’s Chief Medical Officer; Dr. Joseph Schwartz, FACT’s Senior Medical Officer; and Suzanne Birnley, FACT’s Director of Operations. Key topics included accreditation preparation, leveraging FACT accreditation, correcting deficiencies, and post-inspection processes. Additionally, Suzanne provided a walkthrough of the new and improved FACT Accreditation Portal, offering attendees firsthand guidance. A new highlight of this year’s agenda was the LIVE Accreditation Success Story Panel, where representatives from three institutions shared strategies for maintaining compliance across multiple accreditation cycles. While the workshop agenda remains consistent, FACT looks for ways to incorporate the latest information and participants continue to find immense value in connecting with colleagues to discuss the nuances of accreditation.
The Inspector Training Course successfully prepared trainees and provided a refresher for active inspectors. This hands-on training is a unique opportunity for current and future inspectors to gain practical experience. An experienced FACT Inspector guided each training group, with Dr. Phyllis I. Warkentin playing a key role in outlining the inspection process—drawing from her extensive experience conducting hundreds of inspections over the past 25 years.
FACT is deeply grateful to the dedicated volunteers who arrive early to these meetings, ensuring attendees receive high-quality education and training. Looking ahead, we are excited to celebrate FACT’s 30th anniversary prior to the 2026 Tandem Meetings in Salt Lake City, Utah. We hope to see you there!
Establishing a Game Plan: How Written Agreements and Qualification Develop a Winning Strategy Between FACT-Accredited Programs and Third-Party Manufacturers
Cellular therapy is a team sport. The quality of care that is ultimately provided to a patient depends on everyone working together toward the common goal of safe and effective therapy. Multiple people, and increasingly multiple entities, play a role in patient diagnosis and selection; donor assessments and cell collection; cellular therapy product manufacturing, storage and distribution; and administration and follow up.
Sticking with the team sport analogy, everyone involved in cellular therapy should be working from a common game plan. FACT requires several quality management principles that essentially make up that game plan. Written agreements and vendor qualification are two examples.
In this article, we are clarifying FACT’s position on written agreements and vendor qualification required of FACT-accredited programs who collect, process, or administer cellular therapy products that are manufactured by a third-party manufacturer (“third party”). In short, these activities are used to develop and verify the game plan for how the two entities will interact:
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- The written agreement defines the roles and responsibilities of both the accredited program and the third party.
- The qualification verifies that the third party complies with the relevant Standards with respect to interactions with the accredited program.
FACT does not dictate how roles and responsibilities are defined and verified, or in what type of agreement. These could be achieved via Quality Agreements, Master Services Agreements, or relevant policies and procedures that are referred to in other agreements.
Pharmaceutical and biotechnology companies leading the manufacture of a cellular therapy product must have approved Investigational Device Exemptions (IDEs), Investigational New Drug Applications (INDs), or Biological License Applications (BLAs), or equivalent. When a third party has such documented evidence of regulatory oversight and approval, FACT does not require that the agreement defines how it complies with Applicable Law, required accreditations, quality management, or GTP or GMP processes. FACT considers the regulatory approvals as documented compliance with these requirements.
These regulatory approvals do not, however, define roles and responsibilities between the two entities. Just a few examples of relevant activities include chains of identity and custody, shipping, storage, patient scheduling, and communication. A third party or accredited program may have developed preferred processes to increase consistency; however, the two entities will still need to agree on whose processes will be used. (Again, how these responsibilities are defined in written agreements is not dictated by FACT.)
The accredited program’s qualification process will verify that the defined responsibilities will comply with the Standards. As described above, FACT does not require the qualification process to determine compliance with Applicable Law, required accreditations, quality management, and GTP and GMP processes if it confirms regulatory approval for the relevant cellular therapy product.
FACT also does not dictate how qualifications are performed. Agreements can be utilized as a source of information for qualification; separate qualification processes are not necessary (but are also not forbidden). Existing qualification processes can be adapted to utilize written agreements. Use of agreements for qualification is only possible if the right people at the accredited program have access to them.
FACT recommends a collaborative approach to written agreements and qualification as the field evolves. Accredited programs and companies alike are making considerable effort to minimize the burden of onboarding new cellular therapy products, and we are all teammates trying to improve the process so that more patients are treated with cellular therapies that can be lifesaving and life giving.
Which Comes First: Written Agreements or Qualification?
The two are closely related in this scenario and can be done separately or concurrently. Each accredited program, and likely each third party, has proactively developed a process for managing these and no two entities are exactly alike. Some programs prefer to qualify a company before developing an agreement, and some develop an agreement as part of the qualification process. FACT does not require or prohibit either method so long as the intent is met: that roles and responsibilities are clearly defined and in compliance with the Standards.
Teamwork Between Accredited Programs and Third-Party Manufacturers
Because the safety and efficacy of a cellular therapy administered to a patient depends on the cell collection procedure, the cellular starting material, and the manufacturing process, accredited programs must utilize cell collection and processing facilities that meet the Standards.
As accredited programs participate more in research and commercial cellular therapies, they will likely experience increased interactions with pharmaceutical or biotechnology companies who have approved IDEs, INDs, or BLAs or equivalent. FACT does not require that these companies undergo a FACT inspection; however, the manner in which they and the accredited program interact to manufacture and administer a cellular therapy product must still meet the Standards. The program is responsible for defining and verifying processes that achieve this.
The level of participation of the accredited program in manufacturing research or commercial cellular therapy products varies. Regardless of where a product is collected or manufactured, responsibilities must be clearly defined.
Written Agreements Develop the Game Plan
Written agreements are essential to adequately and appropriately manage each step in the cellular therapy process when two different entities are involved. Written agreements provide direction for how the accredited program and the third-party manufacturer will interact to be sure activities meet the FACT Standards.
Although written agreements have been required for several editions of FACT Standards, the need for written agreements for commercialized or research cellular therapy products became abundantly clear over recent years. As an intentionally simple example to illustrate this point, one of the earliest experiences for Clinical Programs was the need to contact a company when a patient’s status changed. When a Clinical Program is in control of the entire cellular therapy process for its patients, it can manage and direct the timing of cell collection and processing. Once those processes are dependent on a separate company, Clinical Programs need to know who to call to develop a plan for how they will need to adjust treatments and reschedule cellular therapy if a patient unexpectedly cannot undergo a cell collection procedure or therapy administration.
It is worth repeating here that, for companies with regulatory approval via IDEs, INDs, and BLAs, FACT does not require agreements to define how the third party will comply with Applicable Law, required accreditations, quality management, and GTP and GMP processes because this is confirmed by the regulatory agency.
The Standards require that agreements include defined responsibilities for critical tasks between the accredited program and the third party. As listed in the Standards, these include collection, processing, testing, storage, distribution and administration and the relevant processes that support these activities. The Standards apply to the Clinical Programs, their collection and processing facilities, and any other entity that performs tasks related to the cellular therapy product, even if that facility only briefly handles the product.
Traditionally, Clinical Programs that have a Cellular Processing Facility receive final cellular therapy products via that facility in compliance with the Part D Processing Facility Standards. Recognizing that Clinical Programs and the intermediaries who receive cellular therapy products are becoming more diverse to meet a growing patient demand, the Standards account for situations when the final product is received directly by the program or an intermediary facility. Intermediary facilities include pharmacies, blood banks, or external storage facilities. These requirements must also be considered when developing written agreements.
What is the Required Format for Written Agreements?
The intent of the Standards is to define the minimal elements to be included in written agreements, but not to define the format of the agreement. Agreements meeting this standard could stand alone or be part of a larger document(s) that exists between the entities such as relevant policies and SOPs, a contract, or a Master Service or Quality Agreement. Examples of ways to manage written agreements with third parties include:
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- A third-party manufacturer may distribute a licensed or regulatory-approved cellular therapy product to a Clinical Program the day prior to expected administration. A policy and SOP shared by the Clinical Program describes the responsibilities and the process for receipt by the institutional blood bank and short-term secured storage at that location.
- A third-party manufacturer maintains a comprehensive Quality Agreement with the institution housing an IEC Clinical Program that includes responsibilities for collection and shipping of the cellular starting material collected by apheresis, and receipt and short-term storage of the finished product at the clinical site.
Some programs have adopted Quality Agreements as a method of defining responsibilities with third parties, and some manufacturers have proactively included quality responsibilities within existing documents such as Master Service Agreements. Neither of these approaches is required by the Standards, but both are permitted. FACT receives many inquiries regarding its requirements for Quality Agreements, and notes that the Standards do not specify this type of agreement and neither requires nor forbids them.
What is the Required Format for Qualification of Third-Party Providers?
FACT does not prescribe a specific form or method for conducting supplier qualification of third parties. It is the responsibility of the accredited program to determine the appropriate approach, whether through a formal supplier qualification process, documented agreements, or other mechanisms that demonstrate the supplier meets the necessary standards. FACT recommends a collaborative approach given the evolving cell and gene therapy landscape and continued efforts to identify efficient and streamlined ways of performing qualification.
Qualification via verifying compliance with regulatory and quality standards through written agreements is acceptable. This is only possible if the appropriate personnel in the accredited program have access to any agreements that may have been established at a higher level in the institution. Programs may need to request the agreements from institutional leaders or the manufacturer if this approach is taken.
Qualification of third parties can be performed in a variety of ways, including but not limited to:
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- Documented verification that pre-determined requirements are addressed via the approved IND, BLA, and written agreements with the institution.
- Questionnaire outlining the established procedures of the third-party. It is acceptable to adapt a Clinical Program’s established questionnaire to allow verification of compliance with requirements via agreements. For example, an existing qualification form could be modified to identify the predetermined requirements for a third-party manufacturer, reference the existing relevant agreement, and document requirements verified via the agreements using the form. This would maintain the effectiveness of the qualification process while reducing the need to perform duplicative work or introduce multiple qualification methods.
Relevant Standards
Clinical Programs
FACT-JACIE HCT / FACT IEC / FACT Common Standards: B1.2 The Clinical Program shall use cell collection and processing facilities that meet FACT [-JACIE] Standards with respect to their interactions with the Clinical Program.
B1.2.1 If the Clinical Program or an intermediary facility receives cellular therapy products directly from a third-party provider, the following responsibilities shall be defined by a written agreement:
B1.2.1.1 Traceability and chain of custody of cellular therapy products.
B1.2.1.2 Cellular therapy product storage and distribution.
B1.2.1.3 Verification of cellular therapy product identity.
B1.2.1.4 Review and verification of product specifications provided by the manufacturer, if applicable.
B1.2.1.5 Readily available access to a summary of documents used to determine allogeneic donor eligibility.
B1.2.1.6 Documented evidence of allogeneic donor eligibility screening and testing in accordance with Applicable Law.
FACT-JACIE HCT / FACT IEC / FACT Common Standards: B4.6 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for the establishment and maintenance of written agreements.
B4.6.1 Agreements shall be established with external parties providing critical services that could affect the quality and safety of the cellular therapy product or health and safety of the donor or recipient.
B4.6.2 Agreements shall include the responsibility of the external party performing any step in collection, processing, testing, storage, distribution, or administration to maintain required accreditations and to comply with Applicable Law and these Standards.
B4.6.2.1 Agreements should include the responsibility of the external parties to provide clinically relevant information related to products or services.
B4.6.3 Agreements shall be dated and reviewed on a regular basis, at a minimum every two (2) years.
FACT-JACIE HCT / FACT IEC / FACT Common Standards: B4.13 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for qualification of critical manufacturers, vendors, equipment, software, supplies, reagents, facilities, and services.
Collection Facilities
FACT-JACIE CM1.2 The Marrow Collection Facility shall use cell processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Marrow Collection Facility.
FACT-JACIE C1.2 The Apheresis Collection Facility shall use cell processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Apheresis Collection Facility.
FACT IEC / FACT Common C1.2 Collected cellular therapy products shall be distributed to facilities that meet the FACT Standards with respect to their role in the therapy.
FACT-JACIE HCT / FACT IEC / FACT Common C4.6 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for the establishment and maintenance of written agreements.
C4.6.1 Agreements shall be established with external parties providing critical services that could affect the quality and safety of the cellular therapy product or health and safety of the donor or recipient.
C4.6.2 Agreements shall include the responsibility of the external party performing any step in collection, processing, testing, storage, distribution, or administration to maintain required accreditations and to comply with Applicable Law and these Standards.
C4.6.3 Agreements shall be established when the Apheresis Collection Facility provides critical services to external parties.
C4.6.4 Agreements shall be dated and reviewed on a regular basis, at a minimum every two (2) years.
FACT-JACIE HCT / FACT IEC / FACT Common C4.13 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for qualification of critical manufacturers, vendors, equipment, software, supplies, reagents, facilities, and services.
Processing Facilities
FACT-JACIE HCT / FACT IEC / FACT Common D4.6 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for the establishment and maintenance of written agreements.
D4.6.1 Agreements shall be established with external parties providing critical services that could affect the quality and safety of the cellular therapy product or health and safety of the donor or recipient.
D4.6.2 Agreements shall include the responsibility of the external party performing any step in collection, processing, testing, storage, distribution, or administration to maintain required accreditations, and to comply with Applicable Law and these Standards.
D4.6.3 Agreements shall be established when the Processing Facility provides critical services to external parties.
D4.6.4 Agreements shall be dated and reviewed on a regular basis, at a minimum every two (2) years.
FACT-JACIE HCT / FACT IEC / FACT Common D4.13 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for qualification of critical manufacturers, vendors, equipment, software, supplies, reagents, facilities, and services.
From the Archives: Transitioning to New and Revised Standards: Advice from the Quality Committee
New editions of FACT-JACIE Standards for Hematopoietic Cellular Therapy (9th edition) and Immune Effector Cells (3rd edition) will be published this year. Many accredited programs are already preparing for the transition process. This article, originally published in 2018 and written by Therese Dodd, BA, MBA, RN, CPHQ, FNAHQ, has many helpful tips. It has been adapted and updated, and still remains true to this day.
Transitioning to New and Revised FACT Standards: Advice from the Quality Committee
Managing change is a difficult task we are faced with on a daily basis. FACT provides guidance and resources to help navigate changes from one edition of Standards to the next. With an enthusiastic staff, a thorough plan, and the right resources, your program will be able to proactively address the changes and avoid feeling overwhelmed. The purpose of this article is to provide tips and references for transitioning to new Standards editions.
FACT releases new editions of Standards on a three-year cycle, issuing interim standards as needed. The public comment period is your first opportunity to preview changes that will be made. The draft Standards and Accreditation Manuals are made available to the public for review and comment nine months in advance of final publication. Even though the Standards are not finalized, the drafts released at this time allow your program to begin a preliminary assessment of the new edition’s potential impact on its policies and processes.
Immediately following publication of a new Standards edition, begin assessing the new and revised requirements and implementing changes as necessary to become in compliance before these Standards become effective.
Operational changes for FACT compliance are often most efficient if leadership-driven; therefore, the first step is to assign a leader or group within your organization who will be responsible for implementation (e.g., Program Director, Administrator, or Quality Committee). Next, a point person or group should be identified to facilitate review of existing and proposed standards along with the summary of changes provided by FACT. The Accreditation Manual should be referenced for guidance. The focus of a preliminary review will be on the intent of the new edition of the Standards.
Next, perform a gap analysis, which compares specific requirements against existing policies and procedures. Evaluate how changes in the Standards will affect current processes and determine new methods for compliance. Use the FACT self-assessment tool, which is published with each new edition, to effectively and efficiently track new or revised standards, gap analysis information, and follow-up plans. Developing a crosswalk between the new Standards and an organization’s relevant SOPs, forms, worksheets, and labels will assist the program with identifying deficiencies in compliance with the new edition. This gap analysis will flag concerns that will require review and discussion at an organizational level.
A gap analysis should not focus solely on the new or revised standards but also include standards that remained the same. This is an excellent opportunity to proactively evaluate overall compliance with the FACT Standards and further prepare your program for future inspections. Furthermore, the program must verify that implementation of policies and procedures for new or revised standards does not adversely affect its compliance with existing standards.
Feedback from all critical stakeholders should be addressed. Ways to accomplish this is to tap into existing committee structures or by chartering working group(s) with delineated scope and schedules. Key personnel from all facilities (i.e., clinical, collection, processing, and cord blood banks) should collaborate to identify issues relevant to the group including, but not limited to:
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- Which documents in each facility will need to be created or revised?
- Which personnel within each facility will be impacted (e.g., will require training and competency)?
- How will the change affect work processes?
- Are dedicated meeting(s) with affected staff required?
Some methodologies for assessing compliance and identifying noncompliance (or predicting the risk of non-compliance) with new or revised standards include procedural review, audits, and mock inspections. To evaluate potential impact on policies and processes for high-risk activities, conducting a predictive failure analysis, using a tool such as Failure Mode Effects Analysis (FMEA), may be warranted.
Effective meetings will result in the best outcomes. If possible, group members should schedule time for meetings, recognizing that regular attendance and active participation are essential. Members of each facility should prepare and present an agenda for common discussion, circulating it and any handouts for review in advance. Discussion items should be summarized with conclusions and action items should be assigned both a responsible party and a target date for completion.
Participants are responsible for identifying change(s) in the standards they are assigned, ensuring these revisions are tracked in the crosswalk with facility and organization policies and procedures. Prior to presenting at larger organizational meetings, smaller working group meetings may be helpful to agree on the plan for the standards to be discussed.
It is helpful to develop and manage an implementation plan for needed changes identified by the gap analysis. This is a dynamic activity that addresses logistical concerns and changes required, solutions to new issues, action items with due dates, and staff assignments. Again, crosswalks developed using the FACT self-assessment tool can help with organizing these activities; however, for particularly complicated action plans, a separate tool(s) may be necessary.
In addition to assistance provided by FACT staff, FACT provides a variety of useful and practical resources that may support organizations’ compliance with new, revised, and current standards. Organizations can prepare early by regularly reviewing FACT resources, including, but not limited to:
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- the “Just The FACTs” newsletter,
- Ask FACT,
- Email,
- Social media accounts on X and LinkedIn,
- Educational events, and the
- FACT Quality Handbook: A guide to implementing Quality Management in Cellular Therapy Organizations.
Additionally, the online FACT Cellular Therapy Library and FACT Cord Blood Library include tools for organizations including the FACT Self-Assessment Tool mentioned earlier, Document Submission Requirements, Summary of Changes, and numerical crosswalks between old and new Standards editions. In-person events are also offered to facilitate the Standards transition process and allow opportunities for interaction with FACT leaders. Check the FACT website’s calendar frequently, as FACT’s educational events include many sessions throughout the year such as webinars, workshops, and Quality Boot Camps. FACT recommends using multiple sources of educational resources based on your organization’s learning style and focus.
Once transition changes are identified and proposed solutions are discussed and agreed upon, these solutions must be implemented in accordance with the program’s quality management plan. Policy and procedure revisions must be documented and approved with defined effective dates. The change process must involve all affected personnel, providing them with associated documents and other resources in advance of the change to allow them time to complete required training prior to implementation. To help error-proof the process change, retired documents must be archived appropriately and outdated documents must be removed from use.
Once changes are deployed, it is prudent to review and analyze the impact of the changes on the quality management systems. Some methods to accomplish this are:
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- performance of an audit for effectiveness,
- review of staff training records and/or competency testing, and
- assessing the availability of current documents at all relevant sites.
To close the loop on implemented changes, it is essential to provide feedback to responsible groups and personnel.
Armed with your plan, engaged staff, and FACT resources, the transition to the new edition of Standards will be efficient and effective. Please contact the FACT Headquarters with any questions. The staff can refer you to the right resource to solve your problem. We all recognize that change is inevitable, but with the right resources, change can be managed.
Back by Popular Demand: ASTCT Fundamentals of HCT Training Course Meets a Critical Need for a Growing Number of Providers
As patient demand for transplant and cellular therapy grows, so does the need for trained practitioners who can provide these therapies.
Join ASTCT for the 2025 Fundamentals of HCT Training Course, a comprehensive two-day virtual program from April 3-4. Designed for advanced practice providers, fellows, pharmacists, nurses, and other early-career professionals, this course provides a broad introduction to hematopoietic cell transplantation (HCT) and cellular immunotherapy (CI). With a strong emphasis on pharmacotherapeutic management, participants will engage in case-based learning and interactive discussions to develop essential skills for managing patients undergoing these advanced therapies.
Attendees can earn up to 14.5 continuing education credits by participating in real-time sessions, with access to session recordings available through May 4, 2025. (This is a great way to meet FACT continuing education requirements!)
Don’t miss this opportunity to enhance your expertise in HCT-CI—register by April 2, 2025, at 5 PM CT! Visit the ASTCT website to see the full agenda.
Who Dat?! ISCT to Offer Comprehensive and Exciting Scientific Program in NOLA
As they say in New Orleans, attendees are sure to “pass a good time” at the ISCT Annual Meeting in the city from May 7-10, 2025.
The comprehensive Scientific Program will include the following:
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- The Translational Pathway Program includes 24 plenary and concurrent sessions in which global key opinion leaders are invited to present novel research, data, and ideas that will shape the future of the cell and gene therapy translation sector.
- ISCT Roundtables include 50 workshop-like sessions that leverage the interdisciplinarity and depth in the expertise of ISCT delegates to tackle pressing practical problems facing the cell and gene therapy translation sector and provide a platform to collaborate on timely practical solutions.
- Lab Practices Essentials are presented by the ISCT Lab Practices Committee and feature eight thoughtfully designed concurrent sessions led by laboratory experts, covering essential topics such as tools, techniques, and personnel training for laboratory professionals.
- Keynote speaker Dr. Fred Appelbaum will be the first to present a Keynote Address at the end of Scientific Programming on the evening of Friday, May 9th, as he discusses the status of our sector and projects into its future.
- Thought-Leadership Events, some by invitation only, ensure attendees stay apprised of sector-shaping discussions taking place in these full-day events.
- Abstracts from over 500 submissions will include posters and oral presentations, which give presenters unparalleled exposure for their research while networking with global key opinion leaders in the field.
Where y’at? Learn more about the Scientific Program and other training events by visiting the ISCT Annual Meeting Home Page and Register Today!
Register for Upcoming FACT Education Events!
April
Apr. 8 – FACT Apheresis Collection Inspector Training Course* at ASFA 2025 | Montréal, Québec, Canada
- *FACT Inspector Training Courses are for approved trainees only. An approved trainee is someone who meets the initial qualifications and has completed the required prerequisites. FACT will directly notify applicants when they are approved and are eligible to register for training. If you are unsure of your trainee status, please contact inspectors@factglobal.org before registering.
May
May 6 – FACT Laboratory Processing Inspector Training Course* prior to the 2025 ISCT Annual Meeting | New Orleans, LA
- *FACT Inspector Training Courses are for approved trainees only. An approved trainee is someone who meets the initial qualifications and has completed the required prerequisites. FACT will directly notify applicants when they are approved and are eligible to register for training. If you are unsure of your trainee status, please contact inspectors@factglobal.org before registering.
June
June 24 – FACT Apheresis Collection Virtual Accreditation Workshop | Zoom
September
Sept. 4 – FACT Cord Blood Bank Accreditation Workshop at Cord Blood Connect 2025 | Miami Beach, FL
Sept. 4 – FACT Cord Blood Bank Inspector Training Course* at Cord Blood Connect 2025 | Miami Beach, FL
- *FACT Inspector Training Courses are for approved trainees only. An approved trainee is someone who meets the initial qualifications and has completed the required prerequisites. FACT will directly notify applicants when they are approved and are eligible to register for training. If you are unsure of your trainee status, please contact inspectors@factglobal.org before registering.
Sept. 25 – FACT Apheresis Collection Virtual Quality Boot Camp | Zoom
