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FACT Update (March 2022)

  

FACT Update March 2022

by:

Mikaela VanMoorleghem, MPA, Education and Training Coordinator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA

FACT Events at the 2022 ISCT Annual Meeting in San Francisco

It gives us pleasure to announce FACT events at the 2022 ISCT Annual Meeting!

The 7th Annual ISCT - FACT Quality Boot Camp will be held on Tuesday, May 3, from 8 am to 5 pm at the Moscone Center West. This year's quality boot camp will focus on a program’s Quality Management Plan and the annual review of the effectiveness of the overall Quality Management Program. How do you evaluate each key quality topic and incorporate them into your program’s report? The boot camp will discuss tools you may use and how topics may be presented to different groups within your program. Join us for the day and work on Building Your Annual Quality Report.

The FACT Cellular Therapy Processing Inspector Training Workshop will be held on Saturday, May 7, 2022, from 8 am to 5 pm at Moscone Center West. The purpose of this workshop is to train pre-approved individuals to serve as cell processing inspectors. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment through submitting the inspection report and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents. 

Register for the Quality Boot Camp

Register for the Inspector Training Workshop

Apply to be an Inspector

 2021 Highlights: FACT Celebrates Anniversary, Announces Independence in Big Year for Organization

Last year was a big one for FACT. While celebrating our 25th anniversary, we committed to remaining a stalwart supporter of quality cellular therapy by adjusting our processes to overcome challenges caused by COVID-19 and announced our independence from the University of Nebraska Medical Center (UNMC) after a 25-year relationship. Read on for a review of a fantastic year!

FACT Began Virtual Inspections in Response to the COVID-19 Pandemic

Following a pause in on-site inspections due to the COVID-19 pandemic, FACT re-initiated accreditation renewal inspections virtually in 2021. By all accounts, the virtual inspections have been successful. The applicant programs were well prepared, the processes were generally effective, inspectors were able to verify compliance with Standards, and both inspectors and program staff continued to learn throughout the process. Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. FACT greatly appreciates the hard work of the inspectors and applicants as we transitioned through this challenging time. FACT intends to return to on-site inspections when it is safe and possible to do so. 

FACT Announced Plan for Embracing Continued Growth of Organization

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.

FACT Celebrated its 25th Anniversary

In 2021, FACT celebrated 25 years of working with our colleagues in the field to improve cellular therapy, cord blood banking, and regenerative medicine. Congratulations to all of FACT’s volunteer inspectors, committee members, leadership, accredited organizations, staff, and supporters for making this milestone possible. Although celebratory events were not possible due to the ongoing need for social distancing, the anniversary was celebrated via the virtual workshops, gifts of appreciation to FACT volunteers, and a 25th Anniversary Guest Book.

FACT and JACIE Published the Eighth Edition Hematopoietic Cellular Therapy Standards

The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021. The Standards became effective on August 16, 2021.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and IEC requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards. Following months of initial reviews and revisions, the committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period.

Two Members Appointed to FACT Board of Directors

Two members representing one of FACT’s parent societies 2021-2023, the American Society for Transplantation and Cellular Therapy (ASTCT), joined the FACT Board of Directors for three-year terms (2021-2023). Navneet S Majhail MD, MBBS, MS is the Program Director of FACT-accredited Cleveland Clinic Blood and Marrow Transplant Program. Dr. Majhail served as ASTCT’s President from 2019-2020, and FACT will benefit from his continued leadership in this new capacity. Eneida Nemecek, MD is a FACT inspector from FACT-accredited Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital. She also serves on FACT’s Clinical Outcomes Improvement Committee.

FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp
Drew Record Attendance
 
FACT held its second virtual Inspection & Accreditation Workshop on February 4th and first virtual FACT-ASTCT Quality Boot Camp on February 5th. Over 300 individuals joined each of the live events resulting in record attendance for both the workshop and the boot camp. We express our gratitude 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.

Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Began

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.

FACT Joined International Organizations to Renew Support of ISBT 128 Coding and Labeling

In light of continuing adaptation to accommodate the rapidly expanding cellular therapy field, FACT joined 14 other organizations to issue a consensus statement reaffirming its support of ISBT 128 as the global standard for terminology, coding, and labeling of cellular therapy products. With a growing list of stakeholders and cellular therapy products, real-world experiences highlight the importance of standardized terminology, globally unique identifiers, and internationally readability to protect patient safety.

FACT Participated in Multistakeholder Efforts to Advance Cellular Therapies

FACT continues to participate in several multistakeholder groups to advance cellular therapies. FACT representatives are members of groups conducted by the Standards Coordinating Body (SCB), Parenteral Drug Association (PDA), and Deloitte NextGen Industry Working Group (IWG). FACT also participated in events such as the NMDP/Be the Match AcCELLerate Summit and the 80/20 Task Force Workshop of ASTCT. Planning is underway for the third FACT Regenerative Medicine InterCHANGE, which will take place in January 2022.

Global Affairs

Hospital Privado Universitario de Córdoba, Programa de Trasplante de Médula Ósea in Córdoba, Argentina was the first to earn a Certificate of Completion for Step One under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Stepwise Accreditation Program in May 2021. FACT and the Joint Accreditation Committee of ISCT-EBMT (JACIE) established the stepwise approach to globally improve hematopoietic cellular therapy and make transplantation accessible to patients. The FACT-JACIE Stepwise Accreditation Program aims to improve the quality and safety of bone marrow transplantation in lower-middle-income economies (LMIE) through compliance with established standards; creating a framework for quality management, education, and training; and providing a stepwise process towards full FACT-JACIE accreditation.

Updates to the FACT Inspection Process Based on Successful Experiences in Past Year

Virtual Inspections

In response to the COVID-19 pandemic, FACT initiated a virtual inspection process in lieu of an on-site visit for those cellular therapy and transplant programs seeking to renew their accreditation. As travel conditions and personnel availability allowed, in-person inspections were maintained for programs seeking initial accreditation or adding new services.  Since virtual inspections began in January 2021, FACT has completed over 50 virtual and 20 in-person inspections.  We extend sincere thanks and congratulations to the outstanding volunteer inspectors and diligent applicant program personnel who have worked together to accomplish these accreditations, learn from the experience, and make lasting improvements in the accreditation processes.

Overall, the virtual inspection process has been successful. Although most inspectors and applicant programs prefer the in-person process, inspectors have been able to virtually review the necessary documents and observe physical facilities as well as adequately assess standards compliance. FACT acknowledges there have been challenges for all involved, including learning new technologies and methodologies, and accommodating scheduling delays. Program personnel have worked diligently to update documents in their compliance application to the current versions and to submit newly required documents that facilitate inspector preparation. The requirement for the program to submit to the Accreditation Portal all policies and Standard Operating Procedures (SOPs) referenced in the Quality Management Plan has enhanced inspector understanding of the applicant program. The value of inspector review of these documents in advance is an important lesson learned from the virtual inspection process. This practice is an accreditation process quality improvement that will be retained when in-person inspections resume.

Inspection Requirement: OneNote or the Equivalent

A second lesson learned through the virtual inspection process is not new, but its importance has been amplified in the virtual setting.  Organization is key to a successful inspection! Since July 2021, FACT has required the use of OneNote or an equivalent system for organizing documents in preparation for a virtual or on-site inspection. OneNote is a tool that allows linkage of the documents used to demonstrate compliance to the specific FACT Standard, thereby facilitating rapid accessibility for review. To assist applicants in preparation, FACT has created a OneNote template corresponding to each edition of Standards.   These can be found on the FACT website under Applicant Resources.  Applicants can also refer to the “How to Prepare for a FACT Virtual Inspection” video in the Virtual Inspection Resource Center for additional tips on using OneNote to prepare for the inspection and maintain compliance.

Other software programs are available that permit similar linkage of the Standard to appropriate documentation and are appropriate for the inspection process. Alternatively, applicants could use a completed Self-Assessment Tool or Compliance Application checklist exported from the Accreditation Portal, with the addition of a column that links to the appropriate document and a description of where in the document compliance is found.  A comment added to the Compliance Application when it is completed will facilitate this process. When inspections are in-person, paper binders could be assembled that include all relevant documentation.  The important point is that the standards must be linked to documentation of compliance, and those documents must be readily available for inspector review. Simple storage apps or programs such as Box, are not adequate to meet this requirement.

Accreditation Timelines

FACT does not anticipate further accreditation expiration date adjustments. We are currently working diligently to schedule and complete cellular therapy program inspections that have applications submitted under the seventh edition Standards and begin those inspections to be conducted under the eighth edition. In addition, cord blood bank virtual inspections will begin in March. Scheduling takes into account the date the application was complete and the accreditation expiration date; however, some programs may experience additional delays. Applicant programs are welcome to contact their FACT Accreditation Coordinator with any questions. Programs approaching their accreditation expiration date due to delays from the pandemic or inspection scheduling will not be at risk of losing accreditation. The accreditation status of each program and cord blood bank is official as listed on the FACT website.

 

FACT Hosts Third Regenerative Medicine InterCHANGE

Stakeholders are motivated – and ready – to implement practical, achievable changes to advance cellular therapy and regenerative medicine. This was a theme throughout the third Regenerative Medicine InterCHANGE, hosted by FACT virtually on January 25, 2022. The event was initially scheduled to be in Miami, Florida as part of Phacilitate’s Advanced Therapies Week, but changed to a virtual format due to the ripple effect of the increase in COVID-19 cases in the previous month.

A total of 36 attendees, representing 23 organizations and various areas of subject matter expertise, participated. Participating organizations included professional societies, health care providers, industry, information technology groups, advocacy organizations, accrediting organizations, and multistakeholder groups.

 

The three main objectives of the event were to:

  • Discuss regulatory requirements for the collection of starting material, applying approaches taken from currently licensed cellular therapies to anticipate and influence requirements for additional cell sources being investigated.
  • Develop a collaborative approach to educational and training programs, building and supporting a thriving workforce by leveraging the resources of academia and industry sectors.
  • Identify steps in the Investigational New Drug (IND) application, licensure, or equivalent regulatory process that could be addressed to reduce time and cost requirements in order to increase patient access to cellular therapies.

Each of these objectives were the topic of panel discussions. Panelists included a wide variety of stakeholders, whose perspectives brought fresh ideas to address challenges experienced among many different types of cellular therapy products. Audience participation was excellent, with attendees sharing ideas for many actionable solutions. A summary of the discussions and identified action items is currently being drafted.

Intermingled through the event were FACT Accreditation Success Story videos. Two videos highlighted successful multistakeholder efforts, including the ISBT 128 Standard for labeling collected cells intended for further manufacture and streamlined site certification processes. The third and final video was a special message from a cellular therapy patient, shared by the Cord Blood Association, who encouraged cellular therapy professionals to continue their good work and be proud of their accomplishments.

The InterCHANGE planning committee and moderators, listed below, successfully narrowed seemingly daunting challenges into solution-driven discussions:

  • Ian McNiece, PhD: Chair, FACT Regenerative Medicine Task Force and Executive Consultant at CellMED
  • Joanne Kurtzberg, MD: Member, FACT Regenerative Medicine Task Force; President, Cord Blood Association; and Director of the Marcus Center for Cellular Cures and the Carolinas Cord Blood Bank, Duke
  • Corinne Goldberg, MD: Medical Director, Carolinas and South Carolina Region of the American Red Cross
  • David Moolten, MD: Medical Director, Penn-Jersey Region of the American Red Cross
  • Colleen Delaney, MD, MSc: Vice President, Cord Blood Association and Founder and Chief Scientific Officer of Deverra Therapeutics

We look forward to sharing the full summary with the cellular therapy field in the future. In the meantime, we would like to express a hearty thank you to the following organizations for participating in the event and for all your efforts to advance quality cellular therapy for the benefit of patients.

Don’t Miss Anything! Tips for Ensuring Receipt of FACT Emails

Cybersecurity is a must in our digital world; however, important messages and announcements from FACT could potentially be missed if security systems block FACT emails. With the increasing sophistication of email security, and changes to FACT domains following our transition to an independent organization, we encourage you to take steps to ensure you will receive FACT messages. We strongly suggest sharing this article with anyone in your organization who should receive FACT information.

To receive FACT messages, you will need to whitelist our domains. Some individuals will be able to do this on their own, some will need permission from Information Technology (IT) departments to do so, and others will rely on IT to take these steps for them. Get to know your IT colleagues – they will be of help! In most cases, issues with receiving emails need to be resolved by your IT department.

The FACT domains that need whitelisted are:

  • org (FACT’s new domain)
  • org (the current domain for the portal until transition is complete)
  • fact.matrixmaxx.com (FACT’s online store)
  • factweb.org (FACT’s newsletter and email distribution list)

 

If all FACT domains have been whitelisted and you still do not receive emails from us, check your junk folder, clutter folder, or deleted/trash folders. If not there, please contact your IT department and the FACT Office at fact@factglobal.org or your Accreditation Coordinator for additional assistance.

FACT Expresses Deep Appreciation to Outgoing Board Members

Wisdom, intelligence, dedication, and kindness are words that describe all the outgoing members of the FACT Board of Directors, who were recently recognized with service awards. These servant leaders maintained a steady presence in FACT’s early years, steered the organization into new developments in cellular therapies, and guided us through challenges such as the pandemic. They are street-smart visionaries who viewed the future with measured confidence. We genuinely thank these individuals for setting FACT up for success for years to come.

Paul Eldridge, PhD

  • FACT Board of Directors: 2014 – 2021
  • Chair, Standards Development Committee: 2016–2021; Member 2014 - Present
  • Member, Cell Therapy Accreditation Committee 2017–Present
  • Member, Cord Blood Bank Accreditation Committee 2017–Present
  • FACT Representative: WBMT
  • FACT Inspector for 21 years; performed 27 inspections

Joseph Schwartz, MD, MPH
  • FACT Board of Directors: 2013 – 2021
  • Chair, Technology Committee: 2020 - Present
  • Chair, Standards Development Committee: 2013–2015, Member 2010-Present
  • Member, Cell Therapy Accreditation Committee 2012–Present
  • Member, Cord Blood Bank Accreditation Committee 2013–Present
  • Chair, HLA Typing Committee: 2017
  • Member, Education Committee: 2015-Present
  • Professional Relations Committee: 2014-2019
  • FACT Representative: AHCTA
  • FACT Inspector for 15 years; performed 36 inspections

      Dennis Gastineau, MD

      • FACT Board of Directors
      • Past President: 2021
      • President: 2016-2020
      • President-Elect: 2014-2015
      • Vice President: 2010-2013
      • Secretary: 2009
      • Board Member: 2005-2008
      • Inaugural Chair Education Committee: 2007–2013, Member 2014-2021
      • Member, Clinical Outcomes Improvement Committee: 2015-2022
      • Member, Leadership & Nominations Committee: 2010–2021
      • Member Finance Committee: 2009
      • Member, Cell Therapy Accreditation Committee: 2007-2021
      • FACT Inspector for 20 years; performed 31 inspections

          New Member Welcomed to FACT Board of Directors

          Nicole Prokopishyn, PhD, is no stranger to FACT after over eight years of performing inspections and serving on the Standards and Accreditation Committees. In February 2022, she was officially welcomed to the FACT Board of Directors following her appointment as the Standards Committee Chair. We are grateful for Dr. Prokopishyn’s continued service to our organization and are looking forward to her guidance in her new role.

          Updated Versions of FACT-JACIE Hematopoietic Cellular Therapy Standards and Accreditation Manual Available

          The Eighth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been updated to Version 8.1, and its accompanying Hematopoietic Cellular Therapy Accreditation Manual has been updated to Version 8.2.

          Version 8.1 of the Standards became effective on January 14, 2022. The changes from Version 8.0 to 8.1 are clerical in nature, and organizations accredited under these Standards should already be in compliance. Most of the changes in the Accreditation Manual from Version 8.1 to 8.2 are also clerical. Substantive content changes to the manual reaffirm and clarify donor screening and donor lymphocyte infusion (DLI) eligibility requirements. Reference Appendix V in both documents for a summary of the changes.

          The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products.

          FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

          The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

          Download the updated Standards, Manual, and Summary of Changes

          Purchase printed copies of the 8.1 Edition FACT-JACIE Standards

          Purchase printed copies of the 8.2 Edition Hematopoietic Cellular Therapy Accreditation Manual

           

          ASH Publishes Guidelines for Stem Cell Transplantation for Sickle Cell Disease

          The American Society for Hematology (ASH) released its first guidelines for stem cell transplantation for sickle cell disease. The guidelines weigh the risks and benefits of transplantation compared to disease-modifying treatments or potentially curative therapy in development. The guidelines are published in American Society of Hematology 2021 guidelines for sickle cell disease: stem cell transplantation (Kanter, et al. Blood Adv. 2021; doi:10.1182/bloodadvances.2021004394C).

          Key recommendations in the guidelines include:

          1. HSCT should be considered the standard of care for patients who have had or have a high risk for stroke, as well as for all patients with neurologic injury who have a matched-related sibling donor.
          2. Patients with frequent pain and those with recurrent episodes of acute chest syndrome should use related matched allogeneic transplantation rather than standard of care.
          3. Patients with an indication for HSCT who lack a matched sibling donor should use transplants from alternative donors in the context of a clinical trial.

          Read the guidelines

          Congratulations to FACT Inspectors for Receiving ASFA Awards

          We extend heartfelt congratulations to Huy P. Pham, MD, MPH and Christopher Chun, MT(ASCP)HP for receiving ASFA Awards.

          Dr. Pham was awarded the ASFA Lecturer Award, which is bestowed upon an ASFA member who has consistently contributed to the society as a speaker, teacher, or mentor. Dr. Pham is a member of the FACT Board of Directors and the FACT Education Committee and is an inspector. 

          Mr. Chun received the SHS Award, which commemorates the pioneering efforts of the Society for Hemapheresis Specialists which have culminated in the high standards and sophistication which characterize the field of American apheresis. Recipients are hemapheresis specialists who have demonstrated sincere commitment to apheresis and who have emerged as a leader and role model in the field. Mr. Chun is a FACT inspector.

           

          We Want to See You in Person at Upcoming FACT Events! Register Today!

          FACT Events at the 2022 Tandem Meetings in Salt Lake City

          Both the FACT-ASTCT Quality Boot Camp and the FACT Inspector Training Workshop will be held on Friday, April 22nd from 8 am to 5 pm at the Radisson Hotel Salt Lake City Downtown.

          This year's quality boot camp will focus on a program’s Quality Management Plan and the annual review of the effectiveness of the overall Quality Management Program.  How do you evaluate each key quality topic and incorporate them into your program’s report?  The boot camp will discuss tools you may use and how topics may be presented to different groups within your program.  Join us for the day and work on Building Your Annual Quality Report.

          The Inspector Training Workshop is for pre-approved clinical hematopoietic transplant, immune effector cellular therapy, and marrow collection inspector trainees. The workshop is designed to guide the trainee through the inspection experience; from accepting an inspection assignment through submitting the inspection report and participating in the Accreditation Committee Review.

          Register for the Quality Boot Camp

          Register for the Inspector Training Workshop

          Apply to be an Inspector

          FACT Workshop at the 2022 ASFA Annual Meeting in Philadelphia

          The FACT Cellular Therapy Collection Inspection & Accreditation Workshop will be held on May 3, from 8 am to 5 pm at the Sheraton Philadelphia Downtown.

          This workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities. FACT representatives will be in attendance to discuss cellular therapy collection challenges, provide examples on how to maintain quality when faced with different collection protocols, and present a common citations overview. This workshop also includes inspector trainee sessions on how to perform a FACT inspection from start to finish.

          Register for the Collection Inspection & Accreditation Workshop

          Apply to be an Inspector

           

          Corrective Action Plans the Focus of this Year’s Quality Management Webinar Series

          The 11th module of the Quality Management Series is all about corrective action plans.

          The first webinar, hosted on February 26th, was, Overview of Corrective Action Plans. Dr. Carlos Bachier from Sarah Cannon Transplant and Cellular Therapy Program at Methodist Hospital in San Antonio, and Lisa Cantwell MHA, CPHQ from the Blood & Marrow Transplantation Program of the Holden Comprehensive Cancer Center at the University of Iowa, discussed the following:

          1. When a corrective action plan is needed
          2. The purpose of a corrective action plan
          3. Who should be involved
          4. Short term Immediate corrective action, and long-term preventive correction action
          5. How to assess the effectiveness of a corrective action plan

           

          Additional webinars in this series are open for registration at the following links. Advance registration and post-webinar recordings of all webinars in this module can be purchased at a discounted rate.


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