Just the FACTs Volume 2

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

Dear Friends and Colleagues,

I am extremely excited to fully introduce myself as your new FACT President in this newsletter. It is truly an honor and privilege to serve in this capacity. For those of you who do not know me, I received my medical degree from the University of Otago, New Zealand and am Board Certified in Pediatrics and Adult/Pediatric Hematology.  My background is in cell therapies for cancer and post-transplant viral infections. For the past 20 years, I have investigated the efficacy of virus and tumor specific T cells for the prophylaxis and treatment of viral infection after transplant and cancer respectively. I was formally the Director of the Pediatric Lymphoma program and the co-Director of the BMT QA Program at Texas Children’s Hospital / Baylor College of Medicine (Houston, TX). In 2013, I was recruited to head the new Program for Cell Enhancement and Technologies for Immunotherapy (CETI) and The Center for Cancer and Immunology Research at Children’s National Hospital and The George Washington University (Washington, DC).

Taking over the President role from Dr. Dennis Gastineau as 2021 begins, and at a time that cell therapy is rapidly evolving and expanding to new applications, is extremely energizing for me. Since the inception of FACT, the scope of cell therapy has extended beyond its original application in hematopoietic stem cell transplantation to embrace diverse immune cell therapies and therapies using non-hematopoietic cells in the broad area of regenerative medicine. Technological advances have placed many of these treatments in the “mainstream” or at least within a reach of generalized application. Therefore, I see it as crucial that FACT continues to establish itself as the lead promoter for maintaining and improving the quality of all cell therapies through “peer-developed standards, education and accreditation for the benefit of patients”.

Hence, my vision is to ensure that the unique collaborative model FACT has established continues to be fostered and advanced as new cell therapeutics are developed and/or reach the marketplace. It is critical to support the translational and practical aspects of cell therapy in all its facets. I am therefore excited to work with the FACT community to promote the things that FACT does best to ensure that all cell therapies are administered with the highest quality standards to maximize patient safety. Specifically, as an ISCT Past President and a former Director at Large on the ASTCT (formerly ASBMT) Board, I look forward to continuing to foster FACT’s strong ties with its parent societies as well as enhancing collaborations with other key societies such as the Cord Blood Association (CBA) and the American Society for Gene & Cell Therapy (ASGCT). Further, I see the need to strengthen and initiate partnerships with international accreditation bodies as has been achieved already with our partner JACIE. I perceive that strong collaborations with regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) will be vital in the next 5-10 years as cell therapy moves far beyond the blood and marrow (BMT) model.

In closing, I would also like to take this opportunity to profoundly thank Dennis Gastineau for his dedication and commitment to FACT over his tenure. Thank you, Dennis, for all your hard work over this time and I look forward to continuing to work with you in your Past President role!

Finally, as a New Zealander who has worked in Australasia, Europe, South Africa, and the US, I hope I can provide, as your President, a genuine international perspective. I look forward to serving FACT and working with the entire FACT community to the very best of my ability.

Cheers, Cath

FACT Virtual Inspections Update

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

Virtual inspections are currently being scheduled for those programs whose renewal accreditation process was interrupted in March 2020 due to pandemic-related issues. FACT Accreditation Coordinators have communicated information about the process to the Program Directors, Quality Managers, and the primary contact persons at those Cellular Therapy Programs whose inspections were canceled and those that were being scheduled. The FACT Business Manager Is currently contacting these Programs for potential inspection dates with the goal of completing the renewal process prior to the expiration date of the current accreditation for each Program.

FACT has created a Virtual Inspection Resource page on the FACT website at: http://www.factwebsite.org/virtualinspections/.  Numerous documents have been updated and are available there, including guidelines for applicants and inspectors, technology guides, and examples of timelines and agendas. By popular request, a new OneNote template to organize compliance documentation has been developed for the 7th Edition FACT-JACIE Hematopoietic Standards for Cellular Therapy.  Additional resources will be added to this page as they become available.

Following two successful pilot virtual inspections, participating  program personnel, volunteer inspectors, and FACT staff identified several best practices for a virtual inspection and issues for process improvement.    Several topics were identified as key to the success of the virtual inspection process.  Best practices include:

  1. Organization is key. Using OneNote to organize documents was an extremely helpful tool for both program personnel and inspectors.  In OneNote, SOPs, policies, and other supporting documents and examples are linked directly to the specific FACT Standard and checklist question, making demonstration of compliance efficient and clear.  FACT has created a OneNote template containing the 7th Edition FACT-JACIE Hematopoietic Cellular Therapy Standards that is now available on the Virtual Inspection Resources page.
  2. The pilot inspection teams identified several additional documents that would have been very helpful to review in advance of the inspection. While FACT had not planned to require additional submitted documents, this recommendation is an important process improvement to be implemented immediately. Additional documents should be submitted in the FACT Portal via the Virtual Inspection Documents tab of the Document Library, identified by the relevant Standard number at the beginning of the document title. New documents include:
    • Any policy or SOP specifically referenced in the Quality Management Plan.
    • The most recent Annual Report on the Effectiveness of the Quality Management Program. A list of documents has been added to the Applicant Guidelines in the Virtual Inspection Resource Center.
  3. Be prepared to demonstrate tracking and tracing of products and processes from donor identification through product collection, processing, storage, and administration.
  4. It is recommended that each person participate in the inspection at a separate computer to facilitate efficient responses. Having the applicant team together in one conference room is suitable if all attendees are able to see and hear sufficiently; however, it is easiest if participants are in separate rooms or adequately socially distanced to avoid the need for masks that tend to inhibit communication.
  5. If more than one area (for example, both the adult and pediatric clinical programs, or clinical, apheresis, cell processing) uses the same Quality Management Plan, the applicant program should consider jointly reviewing the Quality Management section with all relevant inspectors. This should be included in the agenda when it is created and shared with the inspection team prior to the inspection.

FACT is pleased that the pilot virtual inspections were successful and the lessons learned can be applied to ongoing renewal inspections.   For initial applicants, or programs with a new service or space being added, an on-site inspection will be required.  FACT continues to monitor inspector availability for travel and will schedule in-person inspections when applicants are prepared and inspectors are available.  Virtual inspections for cord blood banks will begin later this spring.

FACT Seeks Inspectors for Virtual Inspections

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

Inspector availability and willingness to participate in the virtual inspection process is critical to FACT’s continued success as the premiere accreditation in cellular therapy. We need and encourage you to participate!

Careful attention has been given to development and implementation of the virtual reaccreditation process from both the applicant and inspector point of view, including training opportunities and written guidelines.  All current active inspectors are eligible to perform virtual inspections. Training for inspectors will begin within the next few weeks starting with those inspectors who have agreed to a scheduled inspection. Virtual inspection training for current inspectors will be all virtual and consist of two steps.  Step one includes viewing a short introductory webinar covering the basics of the virtual inspection process and technology, and reviewing the inspector-related documents in the FACT Virtual Inspection Resource Center, located at: http://www.factwebsite.org/virtualinspections/.

The second step will include small group interactive training with the Accreditation Services Manager, Suzanne Birnley, to demonstrate and practice using Zoom as a platform and to ensure inspectors understand the full functionality available to them.  FACT’s Business Manager Jay Ann Witt, is currently scheduling virtual renewal inspections and will be contacting active inspectors for availability.

Feedback from both inspection teams after two pilot virtual inspections in January was very positive.  The inspectors felt that the preparation process was similar to preparation for an in-person inspection. Slightly more time was required to review additional documents the inspectors requested utilizing RFIs in the FACT Accreditation Portal. On the inspection days, it was beneficial for the inspector to have a printed copy of the checklist or to use two computer screens to enable the checklist or a document to be open on one screen while the Zoom meeting was open on the other. FACT is currently scheduling virtual inspections for two days. Program size and complexity contribute to the amount of time needed, however, allowing two days relieves some pressure and if finished early, allows the inspection team flexibility to plan for the closing meeting and begin report preparation.

We are excited to get this new program established and look forward to participation from all our inspectorate. Additional information and training schedules will be provided soon via email.

Interested in becoming a FACT Inspector? Visit http://www.factwebsite.org/BecomeInspector/.

FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Draw Record Attendance

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

The second month of 2021 brought success by way of greatly increased access to FACT’s education for an expanded online audience. FACT held its second virtual Inspection & Accreditation Workshop on February 4th and first virtual FACT-ASTCT Quality Boot Camp on February 5th. Though the pandemic prevented the conference from taking place in Hawaii during the TCT meetings, it could not stop the cellular therapy community from catching up with dearly missed colleagues over virtual coffee and continuing to advance their programs via e-learning. Over 300 individuals joined each of the live events resulting in record attendance for both the workshop and the boot camp.

We send a huge thank you to our workshop chairs, Dr. Dennis Gastineau and Dr. Jean Sanders; our boot camp chairs, Dr. Kimberly Kasow and Therese Dodd; the FACT Education and Quality Management committees; our fabulous presenters and facilitators; and, of course, our attendees for their abundance of energy and enthusiasm.

FACT Inspection & Accreditation Virtual Workshop – February 4, 2021

The workshop day was divided into morning and afternoon sessions. The morning catered to individuals new to or relatively inexperienced with FACT Standards and the accreditation process. The sessions included:

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

The afternoon was prepared with more advanced content for attendees that had previously attended a workshop and were more familiar with FACT Accreditation. The sessions included:

  • How to prepare for a FACT virtual inspection
  • A sneak peek at the Eighth Edition for Cellular Therapy Standards
  • Data management
  • Outcome analysis


 FACT-ASTCT Quality Boot Camp – February 5, 2021

The boot camp focused on a holistic approach to the quality system by featuring core quality concepts in the presentations and interactive sessions. The boot camp showed attendees how to navigate the quality system from start to finish. The sessions included:

  • What to consider for performing a feasibility needs assessment from a new IEC program perspective
  • An overview of the change control process and its development for new or changing services
  • How to execute the risk assessment process and plan with help from a matrix table
  • Reviewing what to validate and how the validation process works
  • How to establish quality indicators
  • An overview of auditing in terms of what, when, and how
  • Interactive discussions to reinforce the concepts of change control, risk assessment, validation, and audits


Both the workshop and the boot camp included optional sessions at lunch. The first session was an interview with Dr. Nelson Hamerschlak and Dr. Andrea Kondo from the Hospital Israelita Albert Einstein in São Paulo, Brazil. The transplant program leaders discuss how FACT Accreditation has benefited their program and prepared them to safely manage patients during the COVID-19 pandemic. The second session was a speech from incoming FACT President, Catherine Bollard, about her vision for FACT as we move forward. (Click on the images below to watch the videos free of charge!) Jeopardy was a popular segment in both conferences as participants enjoyed reinforcing concepts discussed throughout the day in a fun and interactive method.

The end of the day closed with a third optional session led by FACT IT Business Analyst, Alisa Forsythe, during which she trained accredited users on the FACT Portal.

Click on the images to watch the videos free of charge!

We look forward to FACT’s next Processing and Apheresis Accreditation & Inspection Workshop and Quality Boot Camp on Thursday, May 6 and Friday, May 7, 2021!


FACT Congratulates the Recipients of the 2021 ASTCT Awards!

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

The American Society for Transplantation and Cellular Therapy (ASTCT) presented several awards during the 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience. Several of the recipients are contributors to FACT as past or current inspectors, committee members, or Board members. Congratulations to all of these recipients, and thank you for your commitment to quality cellular therapy and patient care!

  • Lifetime Achievement Award: Hal Broxmeyer, PhD.
  • Public Service Award: Anthony S. Fauci, MD
  • E. Donnall Thomas Lecture: Elizabeth J. Shpall, MD
  • ASTCT 2021 Fellows: Navneet Majhail, MD, MS; John DiPersio, MD, PhD; Krishna Komanduri, MD; Christopher Bredeson, MD, MSc; Effie W. Petersdorf, MD; Sergio A. Giralt, MD; C. Fred LeMaistre, MD; Elizabeth J. Shpall, MD; Daniel J. Weisdorf, MD; A. John Barrett, MD; Claudio Anasetti, MD; Helen E. Heslop, MD; Robert Soiffer, MD; Robert Negrin, MD; Nelson J. Chao, MD, PhD; John R. Wingard, MD; James O. Armitage, MD, FACP, FRCP, FASCO, FAAAS; Allen Eaves, OBC MD PhD FRCPC; Karen H. Antman, MD
  • BBMT Editorial Recipients: Pooja Khandelwal, MD; Amy E. DeZern, MD
  • New Investigator Recipients: Hana Andrlova, MD; Joshua Brandstadter, MD, PhD; Sabrina Copsel, PhD; Eiko Hayase, MD, PhD; Nasheed Hossain, MD; Sherly Mardiana, PhD

Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

FACT accreditation is the threshold for excellence in cellular therapy, including blood and marrow transplantation, immune effector cellular therapy, and cord blood banking. 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 and beginning to resume inspections, we invited a few organizations who are currently FACT accredited to share their suggestions for obtaining and maintaining FACT accreditation. In this article, we focus on improvements programs made to their accreditation preparation based on their experience.

What changes did you make after accreditation was awarded to make the next cycle a bit easier?

Richard Makin, Immune Effector Cell Quality Manager, The Children’s Hospital at Westmead Blood and Marrow Transplant Service

–  A big one is START EARLY. When completing the Compliance Application, we try to get our documents as up to date as possible in the months beforehand so we do not make any changes when submitting documents. It is too hard to do in parallel and too time consuming. It is not really meeting the expectation of compliance either: documents and procedures need to be in active use when the inspectors come to assess.

– Conduct regular FACT meetings. We have monthly FACT meetings throughout the accreditation cycle on top of the quarterly large meeting where we summarize the majority of the quality system elements.

– We have found reviewing Immune Effector Cell data every 2nd Quarterly Quality Meeting useful. This has enabled us to get enough data on efficacy and outcome. It also gives us more time to drill down to the significance of results.

– The paediatric ANZCHOG (now TACTIC) annual meeting (Australia + New Zealand) has been a key meeting for reviewing patient outcomes. This is really well supported by our registry (Australasian Bone Marrow Transplant Recipient Registry), who provides sites specific reports. Each centre provides an overview of all their patients and treatments used. The meeting has expanded to include nurses, quality managers, data managers, pharmacists, and scientists in addition to the treating physicians. This is excellent for real-world data analysis, collaboration, and continuing education.

– The annual report of quality activities has been a very useful tool for quality improvement and has grown to many pages. Again, we need to start early as it takes a long time to compile.

– Our registry has been very helpful in working with us on benchmarking outcomes. When this became a requirement a few years back, we sat down and came up with a plan. Now they have standard database report with indications, transplant numbers, engraftment, GVHD, and survival graphs comparing other sites in Australia and New Zealand. This has helped a lot rather than analyzing ourselves.

Elisha Nixon, Quality Program Manager, Walter Reed National Military Medical Center, Murtha Cancer Center Research Program, Uniformed Services University of the Health Sciences, The Henry M. Jackson Foundation

After our program identified significant deficiencies during our FACT inspection in October 2016, a new Quality Manager was brought on board to revamp the entire program. Processes within the administrative, clinical, and laboratory processes were all modified to a significant extent. Following re-inspection, our program was granted re-accreditation in March 2018. Failure was not an option, and a change in mindset helped staff recognize that every Request for Information (RFI) was an opportunity to improve to guide us towards success.

Three years later, we have successfully maintained a program following best practices within the organization. We strive for continuous survey readiness because we learned a very hard lesson. While falling hard is rough on everyone, learning from those mistakes and implementing solid processes helped our program become even better than we could have imagined.

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

To demonstrate standard compliance for the inspector, each department maintains a shadow notebook to allow for an efficient and smooth review of evidence. The shadow notebook is comprised of tabbed sections of each standard applicable for a department, including a title page and any supporting documents behind the corresponding tab. During our past two accreditation cycles, our program found the shadow notebooks immensely diminished time spent paging through documents. The shadow notebooks eliminate the need to visit multiple sources, specifically in situations when a standard impacts more than one area of the program. A key factor for the development and organization of the shadow notebooks is consistent mock FACT inspections with physician leadership and individual department quality designees.

FACT mock inspections are scheduled with all program departments to provide a format to meet collectively to review all FACT standards. The collective review of the FACT standards allows time for brainstorming and discussion of standard implications across various areas of the program.

Do you have any example approaches for maintaining compliance with the various standards?

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.

FACT standards are at the forefront of any discussion regarding updating a process or procedure. The first question is always, “What does the FACT standard say?” Daily, weekly, monthly, quarterly, and annual audits are used to ensure compliance throughout the accreditation cycle. Certain key standards are incorporated into quarterly programmatic quality improvement meetings to provide an overview of compliance to the program.

Richard Makin, Immune Effector Cell Quality Manager, The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Our routine audit cycle focuses on standard FACT topics and is expanded to assess the implementation of new requirements. When new standards are published, we do a gap analysis against our current SOPs and processes. We do this informally when FACT circulates the drafts and formalize when active.

In summary:

Continuous readiness is the goal of all organizations, which means that 1) actual practice matches what is in the approved policies and procedures and 2) there is a mechanism, such as an audit, to verify implementation. It is critical that programs build systems that assure that compliance can be maintained with accreditation standards on an ongoing basis. A common theme from the suggestions is including the FACT Standards as part of discussions on a quarterly, monthly, and daily basis. Regularly looking at the FACT Standards while discussing new processes and procedures allows an organization to address issues and act on them in a timely manner.

Tools available on FACT’s web page:

When a new edition of the Standards is implemented, the FACT web page at http://www.factwebsite.org/standards/ is updated to include a summary of the changes from the previous edition.  Also posted on this site are updated documents such as document submission requirements and other self-assessment tools.

In the webinar, Using an Electronic Platform for Accreditation Preparation and Continuous Readiness, presenters provided step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness or as a platform to deliver evidence to the FACT inspection team. The webinar is available at http://www.factweb.org/forms/store/ProductFormPublic/using-an-electronic-platform-for-accreditation-preparation-and-continuous-readiness-webinar.

ISCT to Host Webinar on Apheresis Cellular Therapy Product Procurement for Further Manufacturing

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

On March 31, 2021, the International Society for Cellular Therapy (ISCT) will host a webinar titled, Apheresis Product Procurement. The webinar will include the experiences of a collection facility shifting from a service delivery mindset to one considering manufacturing in a regulated environment as manufacturing and clinical care documentation now begin with donor selection, qualification, and collection with more licensed products.

View more details and register

ICCBBA Releases Recommendations from Forum 25 Meeting

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

ICCBBA convened the Forum 25 meeting in Lisbon, Portugal in September 2019, from which the Recommendations to Improve the Quality and Safety of Medical Products of Human Origin were created. The recommendations address traceability, patient safety, ethics, biovigilance and surveillance, and new technologies.

A total of 16 actions were identified from the discussions and feedback from health organizations, regulators, and professional societies. The recommendations also identify stakeholders who may be best to address the actions.

FACT is proud to endorse these recommendations, and is looking forward to seeing the results of these recommendations in the future. Any questions regarding the recommendations can be directed to forum25@isbt128.org.

Save the Date! FACT Announces the Apheresis and Processing Accreditation & Inspection Workshop and Quality Boot Camp on May 6-7, 2021

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021