New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.
FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.
The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
Feedback on draft Standards is a critical step of updating requirements to remain relevant and useful to the current state of cellular therapy. Comments will be accepted on two sets of draft Standards through August 30, 2020. This is a direct way to make your thoughts known on any requirement because each comment is reviewed by the Standards Committee. Do you support the new requirements? Is there a standard that you find to be unclear? Let us know!
The following are descriptions and pertinent links for the two drafts available for review. As a peer-driven organization, we look forward to your feedback!
For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.
FACT – JACIE International Cellular Therapy Standards
The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. 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, or cord blood.
Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.
FACT Standards for Immune Effector Cells
The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.
By: Andra Moehring, MHA, FACT Standards Development Manager
The FACT-JACIE Standards Steering Committee initiated the development of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration this summer.
On July 2, 2019, FACT-JACIE Steering Committee members met in Barcelona, Spain to review the Standards Development process and timeline, and discuss specific issues that require review and consideration for this edition.
During the meeting, the committee reviewed and discussed feedback submitted by our colleagues via the FACT-JACIE Standards survey that was distributed in April 2019. FACT and JACIE appreciate the time and effort that went into providing feedback to help us improve our Standards. The survey was completed by 106 total respondents, in 19 different countries, who provided over 800 comments. Thank you for your feedback!
The subcommittees will begin their review next month, and will provide our colleagues with another opportunity to submit feedback during the public comment period scheduled for April 2020.
Final publication of the Eighth Edition FACT-JACIE International Standards is scheduled for March 2021.
By Andra Moehring, MHA, FACT Standards Development Manager
Dr. John Hansen, physician scientist and emeritus faculty member of Fred Hutchinson Cancer Research Center, died of pancreatic cancer on July 31, 2019. Dr. Hansen was well known for his innumerable contributions to the field of blood and marrow transplantation, his pioneering research and discoveries in Immunogenetics, his pivotal role in establishment of global registries of potential unrelated stem cell donors, and his generosity in mentoring others.
Dr. Hansen was also a founding member of the volunteer expert panel that became FACT’s Histocompatibility Committee, responsible for development of the guidelines by which to measure organizations that accredit histocompatibility services in hematopoietic cellular therapy. FACT accreditation of clinical transplant programs and cord blood banks requires histocompatibility laboratories to meet appropriate standards. As FACT extends accreditation services globally, these histocompatibility guidelines are critical to advancing quality care for patients. Dr. Hansen’s foundational contributions and willingness to share his expertise will continue to impact patients and the cellular therapy field worldwide.
A joint FACT-JACIE Stepwise Accreditation program has been developed to globally improve hematopoietic cell therapy quality, enhance safety for donors and patients, and make transplantation accessible to qualified patients. The approach consists of three incremental steps to accreditation to enable programs to focus on their quality systems first and ensure operations for patient and donor safety. The second phase builds on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes.
Twelve blood and marrow transplant (BMT) centers in Latin America were identified to participate in the initial pilot program.
The first transplant center to be inspected under the FACT-JACIE Stepwise Accreditation Program has offered to share their first-hand experience with the process. While FACT’s standard policy is to not release this information prior to completion of the accreditation process, the program may elect to release results at their own choosing. It is inspiring to hear of the hard work and accomplishments of new programs embarking on their accreditation journey.
The new joint accreditation process also provides an opportunity for continuing education for both applicants and inspectors. At times, subtle differences in interpretation of FACT-JACIE Standards can occur. Professional discussion about potential interpretation is always interesting, educational, and useful to make the next edition of Standards more clear. It also points to the critical role of the Accreditation Committee in maintaining consistency in interpretation and in management of the decisions related to compliance.
The BMT Program of the Private Universitary Hospital of Córdoba in Argentina, was the first centre in Latin America to be inspected as part of a pilot group participating in the FACT-JACIE Stepwise Certification Program. Patrica Abichaín, Quality Manager, explains the preparation process and the inspection that took place on November 20-21.
First joint FACT-JACIE Inspection in Latin America: our experience.
The “Programa de Trasplante de Médula Ósea del Hospital Privado Universitario de Córdoba, Argentina”, member of the Latin America Bone Marrow Transplantation (LABMT) cooperative group, was the first centre in Latin America to be part of the pilot group in the FACT-JACIE Stepwise Certification Program. This project is an innovative proposal for centers in this geographic and economic region to provide a pathway to achieve full accreditation through a step-by-step process.
To be selected for “The Stepwise Certification Program” meant a great challenge for us. It started in July 2017, when we sent the Application Form; a few months later, we received the documentation that should be completed, including the inspection checklist, which became our working tool during several months.
In order to move forward in this process, it was a great advantage to be a joint program (Collection Unit, Processing Unit, and Clinical Unit working together in a single location), strongly motivated by the Program´s Director, who became the leader of a working team formed by the units’ directors, representatives of the units and members of an external company of Quality Consulting. The first task was to perform an internal audit to assess our situation, design a workflow, and finally start making some changes in our way of working.
Completing the inspection checklist was really a huge effort. We spent almost 3 months working on it to achieve the first version that we submitted on March 16, 2018. Fortunately, we had support from FACT and JACIE, who helped us to understand the Standards and demonstrate evidence of compliance.
In the meantime, we began to build a “Quality Management System”. The first step was to name a Quality Manager who wrote a Quality Plan in collaboration with the units’ representatives. This group, our Quality Committee, defined measurable outcomes, performed internal audits, implemented validation plans for critical processes in different areas, worked together with the institution’s Human Resources Management in creating job descriptions for keys positions, adopted both the institution’s System for Document Control (knowing with certainty the importance of this chapter in the scaffolding of a Quality Management System for both the hospital and the transplant program), and developed an Incident Reporting System encouraging personnel to know and use them; involved the institutional Bioengineering section for control and maintenance of critical equipment, as the most relevant items. To accomplish this challenge, it was extremely useful to have access to the FACT Quality Handbook, the JACIE Quality Management Guide, and documents kindly provided by generous centers from Europe and the United States.
In each unit, Standard Operating Procedures (SOPs) were written, discussed, reviewed and implemented. All of them are first version and we will update them in the near future adopting guidance provided by JACIE and FACT inspectors. Besides writing SOPs, we tried to re-organize the activities with regards to human resources, facilities and equipment. We also introduced simple statistical tools in order to follow-up on our measurable outcomes.
During this time, we reviewed and updated the checklist to find the best evidence for each standard. Closer to the inspection date, we multiplied our efforts to be on time!
The onsite inspection took place on November 20–21, 2018 and was performed by a team of four international inspectors (United States, Spain and Norway) from FACT and JACIE. The inspection was performed in a rigorous and friendly way. To note, this was the first time that inspectors of both accreditation organizations worked together on a joint inspection. We could appreciate subtle differences in the interpretation of some standards, which, in turn, enriched the inspection experience in our opinion. Additionally, we took advantage of the exchange of opinions among colleagues in the field of transplantation, which was very useful for us.
At the end, the closing remarks were extremely helpful; we took note of our strengths and our weaknesses, mostly in Quality Management. We are now waiting for the Inspection Report, but in the meantime, we continue working in accordance with the inspectors’ observations and non-conformities found during inspection.
In summary, this was a great experience. We learned that the most challenging thing was to achieve staff motivation and cultural change, but the inspection itself gave us strong encouragement to continue working in order to achieve the FACT-JACIE First Step Certification in the next few months.