FACT Update

Mikaela VanMoorleghem, Education and Training Coordinator

Foundation for the Accreditation of Cellular Therapy

Omaha, NE USA

FACT Announces 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.

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

FACT Continues to Celebrate its 25th Anniversary

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

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

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

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

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

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.

FACT Virtual Inspections Update

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:

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.

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.

Be prepared to demonstrate tracking and tracing of products and processes from donor identification through product collection, processing, storage, and administration.

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.

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.

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

By Stacy Freeburg, FACT Accreditation Coordinator

Read part 1

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

Tags: FACT, Association, Cellular therapy, hematopoietic, foundation, partnership, growth, organization, 25th, anniversary

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