Just the FACTs Volume 3

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

In my first letter to the FACT community earlier this year, I explained that one of my goals is to continue FACT’s position as the lead promoter for maintaining and improving the quality of cellular therapy for the benefit of patients. The unique collaborative model established by FACT is special, and we are excited to continue advancing this model into new cell therapeutics in clinical trials and in the marketplace.

One of the first steps we are taking is to pursue independent status from FACT’s long-time home, the University of Nebraska Medical Center. This change will allow us to continue to rapidly accommodate progress in the field as we have done in years past. FACT will support the extraordinary growth in cellular therapies, indications, and stakeholders, and becoming independent is one example of our commitment to you.

It is fitting that this change will come to fruition at the time of a milestone anniversary. This newsletter highlights exciting ways we are honoring our 25-year history, including our virtual events that always receive high marks of praise and preparing to publish the eighth edition of the FACT-JACIE Standards. There are examples of accomplishments our volunteers have achieved and collegial advice our programs are always willing to share with each other.

Please join us in celebrating our 25th anniversary and the exciting opportunities ahead for FACT.

Cheers, Cath

FACT Announces Plan for Embracing Continued Growth of Organization

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

In the midst of tremendous growth, FACT announced its plan to pursue independent operational status by the end of 2021. FACT has responded to progress and advancements in cellular therapy during its storied 25-year relationship with the University of Nebraska Medical Center, and future opportunities for the organization motivated the FACT Board of Directors to make this change. As an independent non-profit organization, FACT will have greater freedom to operate in a manner that allows it to rapidly and nimbly make changes as needed to pursue its mission to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.

In the official news release on April 5, 2021, leaders of FACT and UNMC expressed their excitement for the future of FACT:

“The relationship between UNMC and FACT is an incredible story of a mutually beneficial collaboration between the international field of cellular therapy and the University. Both UNMC and FACT can take pride in its success.” – Dr. Phyllis Warkentin, FACT Chief Medical Officer

“Twenty-five years ago, UNMC led efforts to form FACT to meet the need for professional standards across the field of hematopoietic cell transplantation. In that quarter-century, UNMC and FACT have enjoyed a long and successful partnership, and we are proud of FACT’s many successes and achievements in its respective fields of expertise. As FACT moves forward as an independent entity, UNMC wishes it nothing but the best, and we expect FACT will continue to grow and achieve greatness in the years to come.” – Doug Ewald, UNMC Vice Chancellor for Business, Finance and Business Development

“This transition represents an incredibly timely opportunity to allow FACT to expand our reach in the cellular therapy field nationally and internationally. As President, I am extremely excited to lead FACT at this transformational time.” – Dr. Catherine Bollard, FACT President

Read the full news release online

FACT Continues to Celebrate its 25th Anniversary

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

FACT is proud to announce its 25th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine.

With more than two decades of leadership experience, FACT is a dynamic, internationally recognized accrediting body for healthcare institutions offering hematopoietic stem cell transplants, cord blood banking, and other cellular therapies. Congratulations to all of FACT’s volunteer inspectors, committee members, leadership, accredited organizations, staff, and supporters for making this milestone possible.

We invite readers to sign our 25th Anniversary Guest Book and leave a greeting, photo, or video. Additional celebratory events and activities will take place throughout the year.

Read and Sign the Guest Book

ASTCT Fundamentals of HCT Training Course Takes Place This Weekend – Registration is Still Open! Course Can be Applied Toward FACT Requirements for Continuing Education

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

FACT encourages you to take advantage of the ASTCT Fundamentals of HCT Training Course. Hosted by one of our parent organizations, this course can be applied toward FACT requirements for continuing education.

The Fundamentals of HCT Training Course is a two-day conference that will be taking place virtually on Saturday, April 24 – Sunday, April 25. This course provides a broad overview and introduction of hematopoietic cell transplantation (HCT), also referred to as blood and marrow transplantation (BMT), as well as cellular immunotherapy (CI). Throughout the lectures, participants will be introduced to numerous aspects of the HCT-CI processes, which are designed to develop or enhance skills required in the management of patients undergoing these procedures. This course incorporates case-based learning to emphasize application of concepts taught through didactic lecture with a strong focus on the pharmacotherapeutic management. Additional details, guidance, and review of clinical materials can also be found in the supplemental electronic handbook. The target audience for this course includes new practitioners, residents, fellows, pharmacists, and nurses or those training in this discipline.

Registration to the virtual conference includes access to the newly revised Fundamentals of HCT eBook. The Fundamentals of HCT eBook provides up-to-date clinical information and covers the entire transplant process from pre-transplant consultation to post-transplant care. This is a great resource!

Registration will close at 4PM CT on Friday, April 23.

Register for the ASTCT Fundamentals of HCT Training Course

Register for the Upcoming Inspection and Accreditation Virtual Workshop on May 6, 2021

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

Join FACT for an inspection and accreditation virtual workshop on Thursday, May 6, from 7:30 am – 5:15 pm CT, 12:30-22:15 GMT. The FACT workshop is intended for apheresis and processing personnel, and serves as the opening act to the May scientific annual meeting headliners, The American Society for Apheresis (ASFA) and The International Society of Cell and Gene Therapy (ISCT). Separate registration is required. 

The FACT workshop morning sessions will interest initial apheresis and processing applicants and those who have limited experience with FACT accreditation.  The afternoon features more advanced content and is designed for those who have attended previously. We encourage all participants to stay for the entire day; however, all sessions will be available on-demand after the workshop for 30 days.  Registrants will have access to both tracks’ on-demand sessions.

Morning sessions include:

  • An overview of FACT Accreditation
  • A review of the compliance application process
  • How to prepare for an inspection
  • A virtual tour of an accredited apheresis and processing program
  • Common challenges apheresis and processing programs encounter and how to correct the deficiencies

Advanced sessions include:

  • How to prepare for a FACT virtual inspection
  • Navigating the Eight Edition Cellular Therapy Standards
  • Maintaining Chain of Identity and Chain of Custody
  • Panel Discussion:  Get your questions from the day answered by the experts!

During lunch, attend optional featured sessions! Listen to FACT’s new president, Dr. Catherine Bollard, reflect on the accomplishments and the future of FACT.  Also, hear from leaders of the Baylor College of Medicine Stem Cell Transplant Program regarding their experience as one of FACT’s first virtual inspection programs.  Learn what worked well, challenges faced by program personnel, and suggestions moving forward.

Register for the workshop

Register for the ASFA Annual Meeting

Register for the ISCT Annual Meeting

FACT Quality Boot Camp in partnership with ASFA and ISCT to Discuss Navigating a Changing Environment Using Quality Systems – Register Today!

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

The next FACT Quality Boot Camp, in partnership with ASFA and ISCT, will take place on May 21, 2021. Discuss and explore core quality concepts throughout the day and learn how to apply those concepts during interactive sessions focused on apheresis and processing. These sessions will provide attendees the opportunity to discuss issues, ask questions, apply concepts learned, and navigate components of the quality system from beginning to end, including:

  • Change Control
  • Risk Assessments
  • Tracking and Tracing
  • Validations/Audits
  • Unexpected Outcomes and Events
  • Corrective Action and Preventive Actions

The intended audience is apheresis and processing personnel. At the end of the day, boot camp participants will be able to apply learned concepts to their own programs’ needs.

Register for the Boot Camp

Register for the ASFA Annual Meeting

Register for the ISCT Annual Meeting

ASFA Presidential Award Bestowed upon Dr. Joseph Schwartz

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

Congratulations to Dr. Joseph Schwartz, FACT Board Member and the recipient of the ASFA Presidential Award! The Presidential Award of the American Society for Apheresis is bestowed upon a member of the Society who has consistently made major contributions to, and performed outstanding service for, the Society over a number of years.

Dr. Schwartz’s contributions to ASFA have been numerous. Holding many Officer positions, including as a past President, he advocated for ASFA representation in many other professional societies and multistakeholder groups. His support for ASFA members included the establishment of a members’ session during ASFA Annual Meetings, implementation of small interest groups, and growth of membership to more than 1,000 people.

Dr. Schwartz has been a FACT inspector since 2006. Since that time, he has served on numerous FACT committees, including as Chair of the Standards and Information Technology committees. Dr. Schwartz is also a member of the FACT Accreditation, Education, and Professional Relations Committees. He has been a FACT Board member since 2016.

His leadership also extends to many other organizations as a Board member, committee leader, and reviewer. He has been awarded the DeGowin Award & Lectureship in Blood Banking, the Joseph S. Fink Laboratory Medicine Faculty Teaching award, the AABB Hemphill-Jordan Leadership Award, and the honor of Elected Member of The Virginia Apgar Academy of Medical Educators and the Academy of Clinical Excellence at Columbia University, Vagleos College of Physicians and Surgeons.

FACT thanks Dr. Schwartz for his servant leadership, and for his extraordinary work in representing apheresis professionals in the growing fields of transplantation and cellular therapy.

ISCT Awards Honors to Dr. Catherine Bollard and Dr. Donald Kohn

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

The International Society for Cell & Gene Therapy (ISCT) announced the recipients of its 2021 achievement awards. Congratulations to Drs. Catherine Bollard and Donald Kohn!

Dr. Bollard, FACT’s President and long-time FACT inspector and committee volunteer, will be the first recipient of the Darwin J. Prockop Mentoring Award. This award recognizes, “an outstanding individual who has excelled as a mentor and has contributed to the ongoing development of their mentees in the field of cell and gene therapy.” The ISCT website quotes fellow FACT Board Member Patrick Hanley’s account of Dr. Bollard’s mentorship: “Cath’s impact on the field of cellular therapy and the practice of medicine is no longer restricted to her own success, but is now emanating in seeds she has planted and nurtured in the over 93 individuals she has mentored, including 22 junior faculty, 27 post doctoral fellows, and 12 graduate students. Dr. Bollard acts as a mentor to other senior investigators at CNH as well, particularly those in the Bone Marrow Transplantation division. Cath is the most deserving mentor for this award.

Dr. Kohn, a member of FACT’s Genetically-Modified HPC Subcommittee, will receive the 2021 ISCT Career Achievement Award. Dr. Kohn is a leader in research in gene therapy, and was instrumental in evaluating FACT Standards in the context of genetically modified cells and recommending additions to maintain the Standards’ relevance as these cells expand further into the clinic. Dr. Jan Nolta described to ISCT the most important contribution he has made, which has been to improve the lives of children: “Prof. Kohn developed the first successful hematopoietic stem cell gene therapy, for children with ‘bubble baby disease’- ADA deficiency – and has now functionally cured over 50 children.

Read more details

Register for the 2021 Virtual ISCT Annual Meeting

FACT-JACIE Hematopoietic Cellular Therapy Standards to be Published in May

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is finalizing the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (HCT 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.

FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells. Publication of these Standards is planned following publication of the HCT Standards. This change in schedule will allow FACT to place priority on updating related accreditation documents for programs accredited under the HCT Standards, whose inspections were disproportionally affected by COVID-related delays.

Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Begins

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

The eighth edition of the NetCord-FACT Cord Blood Banking Standards is officially in development under the leadership of FACT’s new Standards Committee Chair, Dr. Nicole Prokopishyn. The Cord Blood Standards Steering Committee kicked off the process on April 22, 2021.

Any suggestions or comments regarding the Cord Blood Standards are welcome. Please provide  feedback to FACT’s new Standards Development Manager, Monique Summers, at monsummers@unmc.edu.

Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 2)

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

FACT-accredited organizations voluntarily seek and maintain FACT accreditation via a rigorous process, demonstrating their commitment to quality and their belief that patient needs are paramount. Obtaining and maintaining FACT Accreditation is a major undertaking.

Recognizing that we are a peer-driven organization, we invited a few organizations who are currently FACT accredited to share their suggestions for how to maintain many of the documents required for FACT Accreditation.

How does your program organize various documents so that they are readily available, such as current licenses, specialty certificates, or CVs?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

This is a challenge. For large education sessions that are renewable (e.g., Risk Management Program (RMP) training), we have started using the Training Courses module in our Q-Pulse quality management software. This allows for central management and electronic record keeping.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

This information is reviewed on an annual basis to ensure documents are up to date and organized for each employee in our employees’ FACT folders. If updates are needed, the information is requested directly from the employee or obtained though administrative staff. The timing of the annual review of the employees’ FACT folders corresponds with our hospital’s annual employee evaluations. Copies of licensure and certificates for key personnel are stored in a shared electronic folder to allow access to those who may require it throughout the year.

How does your program compile and maintain the educational activities list?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

For the last six to seven years, we have been providing a “BMT Masterclass”. The schedule of topics is based on the FACT requirements. This is a virtual presentation or prerecording. These are recorded and subtitled and placed on our website at https://aci.health.nsw.gov.au/networks/blood-and-marrow-transplant/resources. All members of BMT Nurses, Scientist, Physicians, and Pharmacists in New South Wales (NSW) and across Australia have access. We also run a “Introduction to BMT” session once a year, a scientific forum, and senior nurses’ day.  We use a basic template for recording.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Our program utilizes the FACT Educational Activities Form throughout the program departments to document cellular therapy education on an annual basis. Key team members maintain their own educational activities form, and the form is part of the annual audit of the individual employees’ FACT folder.

Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation

When I worked in direct health care, a sign-in sheet was provided for all internal training to document educational activities. Information gathered included training title, date and length of the training, title of the training, and attendees’ name. In addition, staff were expected to submit documentation of any external training to a central location. This information was compiled onto a word document for each staff member (similar to the FACT Educational Activities Form). The sign in sheets also provided documentation that the organization provided opportunities for staff for educational activities.

 Staff also were required to update their educational activities in a system tied to the Human Resources department’s intranet. Information gathered included the activities’ titles and dates and length of training. Activities could be webinars, reading an article, etc. Staff were then able to print out a summary form. All staff were required to turn in a copy during their annual personnel evaluation, which demonstrated compliance with requirements and made it readily available for submission for accreditations.

Benefits of Documenting Educational Activities

Documentation is not only a way to document educational activities for FACT Accreditation, but can also be a resource for planning future training needs. To maximize the usefulness of educational activity records, it is important that they be up to date, organized for easy retrieval, and have a mechanism to for review. By reviewing the types of educational activities staff have attended, programs can determine what education is needed. For example, the program may wish to expand opportunities to include tumor board discussions, review of peer reviewed articles, or ensuring that staff have the opportunity to attend various professional conferences.

As noted above, gathering licenses and educational activities is challenging. Tying the submission to annual performance evaluations or having an annual audit to verify it is complete are two methods to avoid a panic when you need to submit the information.

Download the FACT Educational Activities Form