Accreditation Statistics

As of August 1, 2022

Cellular Therapy Entities

  • Accredited: 250
  • Applicants: 25

Cord Blood Banks

  • Accredited: 56
  • Applicants: 7

Congratulations to the following program for achieving initial FACT accreditation: King Abdulaziz Medical City - Riyadh, Saudi Arabia (adult and pediatric allogeneic and autologous hematopoietic progenitor cellular therapy; marrow and peripheral blood cellular therapy product collection; cellular therapy product processing with minimal manipulation). A complete list of accredited organizations can be found at www.factwebsite.org.

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.