Accreditation Statistics

As of January 2, 2024

Cellular Therapy Entities

  • Accredited: 260
  • Applicants: 26

Cord Blood Banks

  • Accredited: 49
  • Applicants: 10

Congratulations to the following organizations for achieving initial FACT accreditation:

  • Houston Methodist Ann Kimball & John W. Johnson Center for Cellular Therapeutics
  • Blood Assurance
  • American National Red Cross, Salt Lake City, Utah HCT/P Program

A complete list of accredited organizations can be found at

Adverse Event Reporting to FACT

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

By Stacy Freeburg, FACT Accreditation Coordinator

Programs monitor adverse events for patient safety and report events to third party organizations (FDA, Trial Sponsors), who consider the implications of single adverse events and compile the data to identify potential trends. Management of adverse events within an organization related to the administration of cellular therapy products is required by the FACT Standards.

FACT defines an adverse event as any unintended or unfavorable sign, symptom, abnormality, or condition temporally associated with an intervention that may or may not have a causal relationship with the intervention, medical treatment, or procedure. An adverse reaction is classified as a type of adverse event. In the standards, references are made to adverse events that encompass required detection, investigation, documentation, reporting, corrective and preventive action, and the responsibility to report incidents to different entities.

If an unexpected or serious adverse reaction occurs due to cellular therapy product collection or administration for which there is a reasonable possibility that the response may have been caused by the product, the report of the adverse reaction and its outcome and investigation should be communicated to all facilities associated with collection, processing, and/or administration of the product.

Organizations must comply with FACT Standards and policies throughout their accreditation cycle, including submission of the Annual and Renewal Report within 30 days of receipt (refer to the FACT Maintaining Accreditation Policy). The Annual Report is sent on the 12-month anniversary of current accreditation, whereas the Renewal Report is sent 14 months prior to expiration.

These reports allow organizations to update FACT regarding their demographics, changes in key personnel, facilities, or services, and submit required documentation of corrective action, as applicable. The report also requires programs to provide an explanation of any serious or unexpected adverse event that occurs during the reporting period. As defined by the FDA, serious adverse events have a severe impact on an individuals’ health, potentially leading to life-threatening consequences, permanent damage, or extended hospital stays (refer to the FDA, “What is a Serious Adverse Event?”).

When reporting an adverse event, organizations must include an explanation and supporting documentation that demonstrates compliance with the FACT Standards and includes the following:

  • A description of relevant patient details. Do not include Protected Health Information (PHI).
  • A description of relevant product details, if applicable.
  • A summary of how the event was identified and investigated, corrective action(s) implemented, and that appropriate follow-up of implemented corrective action(s) was performed to ensure the corrective action(s) were effective.

Referenced Standards:

  • 3.4.8 Management of complications related to the administration of cellular therapy products.
  • B/C/D4.10.4.2 Occurrences shall be reported to other facilities performing cellular therapy product functions on the affected cellular therapy product and to the appropriate regulatory and accrediting agencies, registries, grant agencies, sponsors, IRBs, or Ethics Committees,

FACT Launches 2024 Education Season

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

We are thrilled to announce the launch of the 2024 FACT Education season! This year offers an array of enriching experiences both virtually and in-person across the globe.

Visit FACT’s Calendar of Events to register for upcoming education opportunities.

The 2024 FACT Quality Boot Camp spotlight shines on Process Validation, where FACT instructors delve into the intricacies of developing validation plans and will cover aspects such as purpose, responsibilities, acceptance criteria, data collection, risk assessment, and summary of results. The day kicks off with an enlightening overview of validations, verifications, and qualifications. Participants will actively engage in developing validation plans for critical processes, including Bone Marrow Collection, Preparation for Administration, and Infusion, ensuring a highly interactive learning environment.

Our interactive Cell Therapy Accreditation Workshop takes a deep dive into FACT’s Standards and accreditation process, offering a dynamic format facilitated by experienced instructors. Through case studies and collaborative discussions with peers, participants will gain insight into accreditation requirements, positioning their organizations for accreditation success, maintaining readiness, and addressing common citations. The workshop covers audits, corrective action plans, and strategies for enhancing clinical outcomes and data management.

For those aspiring to become FACT inspectors, training opportunities await. Tailored exclusively for inspector trainees who have completed prerequisites, the FACT Inspector Training Course offers practical, hands-on sessions led by experienced FACT inspectors, simulating the actual inspection process. Covering technology tools, preparation essentials, common citations, inspection procedures, and post-inspection expectations, this course provides a comprehensive foundation for those looking to contribute as FACT inspectors. To explore this exciting opportunity, contact Suzanne Birnley or visit

Get ready for a season of unparalleled learning and professional growth with FACT Education in 2024!

Thank you to our partners for their generous support:




Planning a Move? Tell Us Your Plans! Required Documentation for Relocations

Posted in :: 2023 Volume 6 :: Thursday, October 26th, 2023

by Stacy Freeburg, Accreditation Coordinator

They say the only thing constant is change. This is true for healthcare facilities, which are often rearranged, remodeled, or built new to meet the shifting needs of patients. What does not change, though, is an accredited organization’s responsibility to maintain compliance with FACT Standards throughout a move of cellular therapy-related activities.

FACT used to automatically require an interim inspection of new or relocated facilities so that compliance with Standards could be verified. In 2013, after reviewing several years of relocation inspection results, the FACT Accreditation Committee determined that such inspections are not always required because sufficient information could be provided.

The current policy requires accredited organizations to update FACT within 90 days of a facility relocation and submit specific documentation to demonstrate compliance with FACT Standards. This includes temporary moves. The Chair of the FACT Accreditation Committee reviews the documentation and determines if a relocation inspection is necessary. It is recommended that organizations notify their assigned Accreditation Coordinator in advance if a relocation is planned, and organizations should expect to provide the following information, as applicable:

  • A description of the new facility.
  • An explanation or reason for the move.
    • If the move is temporary, include a timeline for when services will resume at the current location and the revalidation plans for the processes, facilities, and equipment.
    • Mailing and physical address of new and old locations, including building, floor, wing, room number.
      • Include the distance between the old location and the new location, if applicable.
      • Indicate if the new location has been inspected by FACT previously.
    • Date operations started at new facility and type of processes.
    • The date when the move occurred.
  • A risk assessment of the move, including how adequate space and protection from airborne microbial contamination and provision of adequate medications, blood products, and other critical services, were maintained during the relocation.
  • A detailed floor plan (with clearly marked rooms, exits, restroom facilities, any isolation rooms, storage areas, irradiators, etc.) and the identification of the new location.
  • A summary of any changes to the Quality Management Plan, if applicable.
  • A summary of the SOPs that were created or revised because of the relocation, as applicable, and provide an example of a revised SOP.
  • A summary of staffing changes, if applicable.
  • Include a summary of the validations, revalidations, verifications, or qualifications that were performed due to the relocation.
    • Submit a completed example for one of the following: validation, revalidation, verification, or qualification.
    • Include a schedule for completing these assessments if not completed at the time of submission.

Establishing a New Collection or Processing Facility at a FACT-Accredited Clinical Program

Posted in :: 2023 Volume 4 :: Thursday, July 27th, 2023

By Sarah Litel-Smith, BSMT (ASCP), FACT Accreditation Services Supervisor

FACT-accredited Clinical Programs are required to use Collection and Processing Facilities that meet FACT Standards with respect to their interactions with the program. A program with an opportunity to establish its own collection and/or processing facilities must ensure continued compliance with the Standards, including during the transition of operations to the new facility. As outlined in the Maintaining Accreditation Policy available on the FACT website, the accredited program will need to continue to use the currently accredited facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.

A new Collection or Processing Facility is required to be established, in operation for 12 months, and perform the minimum number of procedures prior to accreditation. The application for accreditation can precede the 12 months of operation, provided key personnel, processes, validations, and documented staff training are in place for at least nine months before inspection.

The Clinical Program must notify FACT of the intention to use a new Collection or Processing Facility prior to its use and develop a transition plan. FACT will review the proposed transition plan to determine an appropriate percentage of patient products the new facility may collect or process for the program prior to achieving FACT accreditation.

The proposed transition plan should address the following, as well as each category outlined in the table below:

  • Identification of key personnel, including a description of qualifications, relevant experience, education and training, and number of personnel.
  • A description of the number and types of cellular therapy products to be collected or processed.
  • A description of facility location, layout, and equipment.
  • A description of the Quality Management Plan, completed qualifications, validations performed, and written policies and Standard Operating Procedures describing collection or processing processes.
  • A plan to perform an initial assessment of three collected or processed patient products for yield and viability in comparison to products collected or processed by the currently accredited facility, and the plan to reassess patient products at pre-determined intervals.
  • Assurance that the Clinical Program will continue to use the currently accredited collection or processing facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.
  • Timeline for the new facility becoming FACT accredited, and when FACT can expect progress reports regarding the transition.

TABLE: Steps for Establishing a New Collection or Processing Facility

Step Category Action Standards
1 Facilities Identify the location of the Collection or Processing Facility, layout, and equipment. Ensure facilities include appropriate designated areas for activities, are of adequate size, and are suitable for the activities to be performed. C2, D2
2 Personnel Hire key personnel. Ensure the Facility Director, Facility Medical Director, Quality Manager, and a minimum of one additional designated staff member are appropriately trained, qualified, and experienced. C3, D3
3 Equipment Acquire required equipment and complete critical qualifications. C8.2, D6.4
4 Policies and Standard Operating Procedures: Develop collection or processing Standard Operating Procedures. C4, C5, D4, D5
5 Quality Management Create a Quality Management Plan and document control system. C4, C5, D4, D5
6 Validations Perform an initial assessment of three collected or processed donor products for sterility, yield, and viability in comparison to products collected or processed by the currently accredited facility. C4.14, D4.14
The date of facility establishment is the date the first validation run is performed or later.
7 Notify FACT Notify FACT of intention to add new Collection or Processing facility, and progress to date.  
8 Register Register with the appropriate authorities. Register with ICCBBA, and implement and validate ISBT 128-compliant labels. C1, D1

C7.4, D7.4

9 Transition Plan Submit a transition plan to FACT for review prior to collecting or processing patient products for administration at the new facility. The Clinical Program must continue to use the currently accredited facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.  
FACT will review the plan and, if appropriate, approve a quantity of patient products to collect or process sufficient to maintain competency. The majority of products will be collected or processed at the accredited facility until the new facility is accredited or meets accreditation requirements
When multiple collections are planned, it is advisable to have one product collected or processed at the currently accredited facility and one at the new facility to compare engraftment, product dose, viability, and sterility results of each facility. If this is not possible, we recommend collecting or processing patients in cohorts of no more than three and evaluating engraftment, product dose, viability, and sterility of each cohort before starting another cohort.
10 Eligibility or Add-On Application The new facility can begin an Eligibility or add-on application six months after establishment by submitting the request and an update on progress and completed Facility Grid.  
A new collection or processing facility is required to be established, in operation for 12 months, and perform the minimum number of procedures prior to accreditation. The application can precede the 12 months, but key personnel, processes, validations, and documented staff training in the collection or processing procedure(s) must be in place for a minimum of nine months before inspection.


From the Archives: FACT Resources to Assist Your Program throughout the Accreditation Process

Posted in :: 2023 Volume 2 :: Thursday, April 27th, 2023

FACT provides a voluminous amount of resources – a treasure trove of information for accredited and applied organizations, volunteer inspectors, and external stakeholders. We want everyone to succeed, and we are committed to providing documents, forms, checklists, education, and more to advance cellular therapy.

The time that has passed since the original publication of this Just the FACTs article in 2020 was marked with many transformations. The world endured a pandemic, the cellular therapy field celebrated several advancements, and FACT launched a new website. We’ve also welcomed many new stakeholders, from new personnel at accredited organizations to new manufacturers of cellular therapy products, and have received feedback that not all are aware of the valuable tools available online. (Of special note – the Accreditation Manuals and Quality Management resources are examples of beneficial resources not known by some.)

Revisit this list of online resources through the lens of a new website and updated links, and be sure to share it with all of your colleagues!

FACT Resources to Assist Your Program Throughout the Accreditation Process

FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times especially for organizations completing their initial application or for personnel new to the accreditation process.

The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process.

FACT Standards

The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:

The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:

  • Standards documents: These are the official publications of the FACT Standards, and list the requirements for achieving and maintaining FACT accreditation.
  • Accreditation Manuals: These are guidance documents used by accreditation applicants and FACT inspectors that explain the intent and rationale for specific standards, provide examples of alternative approaches that would be considered compliant with standards, and detail the type of documentation that may be used to verify compliance. The examples listed are not requirements and are not all-inclusive.
  • Edition-specific information: To assist with transitioning to a new edition of Standards, documents such as a Summary of Changes and crosswalks are provided to identify changes between the previous and current editions of FACT Standards.
  • Standards-specific resources: Self-assessment tools, checklists, and forms used to prepare for and conduct the accreditation process are provided. Examples include, but are not limited to, Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.

Accreditation Process Requirements

The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements web pages provide a structured overview of the accreditation process, from determining eligibility for accreditation to requirements after the on-site inspection.

Educational Resources

FACT’s comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:

Clinical Outcomes Resource Center

FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.

Data Management Resource Center

The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.

Immune Effector Cells Resource Center

FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.

Quality Management Resource Center

FACT has developed quality-based educational materials to assist your organization with developing and enhancing your Quality Management Program. The Quality Management Resource Center includes links to the FACT Quality Handbook and recordings to several Quality Management Webinar series.

Portal Resource Center

The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal. The How-To Guides have been updated to assist users with the upgraded portal.

FACT Accreditation Coordinator

Each applicant organization is assigned a FACT Accreditation Coordinator to provide assistance and direct personnel and inspectors to the above resources and more. Your Accreditation Coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal and also on the FACT website’s Contact Us page.

We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email

King Abdulaziz Medical City – Riyadh, Saudi Arabia is first Cellular Therapy Program in Saudi Arabia to earn FACT Accreditation

Posted in :: 2022 Volume 3 :: Wednesday, August 17th, 2022

OMAHA, Neb. – King Abdulaziz Medical City – Riyadh, Saudi Arabia received internationally recognized accreditation by FACT. Directed by Mohsen Alzahrani, MD, it is the first and only cellular therapy program in Saudi Arabia to be recognized by FACT.  The program received accreditation on July 1, 2022 and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.

“The FACT accreditation process has been a long and exciting journey with a significant learning experience. Our entire transplant team, with the help from the hospital’s multidisciplinary support services, worked tirelessly to make this major achievement possible. It is a great privilege to hold the distinction of being the very first institution in Saudi Arabia and the region to be awarded FACT accreditation. This remarkable achievement demonstrates clinical excellence, spirit of teamwork, collaboration, professional commitment, and administrative support,” stated Dr. Alzahrani. “It is our belief that FACT Accreditation will make our colleagues and patients aware of our facility’s commitment to providing the best possible care for cellular therapy and that we are committed to uphold the highest possible standards of care.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Achievement of FACT accreditation requires dedication and perseverance, and demonstrates that Dr. Mohsen Alzahrani and staff have established a high-quality program in hematopoietic cellular therapy and transplantation.  I congratulate these leaders in the region on this accomplishment.”

FACT Announces Return to In-person Inspections October 1, 2022

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

Sarah Litel-Smith
Supervisor, Accreditation Services

FACT is excited to announce the return of in-person on-site inspections beginning October 1, 2022. Virtual inspections for renewal applicants were implemented in 2020 in response to the COVID-19 pandemic. While these virtual inspections have generally been successful as an interim measure, there have been some challenges and more delays than anticipated.

A recent survey of active inspectors indicates that most are comfortable with travel, at least domestically; their institutions permit travel; and applicant organizations are able to accommodate inspection teams.  The return to in-person inspections will allow more expeditious inspection scheduling and facilitate much needed inspector trainee participation. The 40 new inspectors who completed an Inspector Training Workshop this spring at the ASTCT, ASFA, and ISCT meetings are anxious to complete their required trainee inspection. Please volunteer to be a mentor if you are an inspector and welcome a trainee inspector when your program schedules its on-site inspection.

Virtual inspections already scheduled through the end of September will be performed virtually as planned. If deemed necessary to protect the health and safety of inspectors, staff, and patients, or in response to other restrictions,  FACT may conduct additional virtual inspections as needed. Contact your Accreditation Coordinator or FACT at, or 402.920.7001, if there are any concerns related to the next on-site inspection.

FACT Accreditation a Criterion in the 2020-2021 US Best Hospitals List

Posted in :: 2021 Volume 5 :: Tuesday, October 26th, 2021

U.S. News and World Report released its 2020-2021 Best Hospitals List, and FACT accreditation was again used as a ranking criterion for the cancer specialty. Since 2007, accredited programs receive a point value based on their accreditation.  One point was given if accreditation was only for autologous transplants, and two points were given if accreditation was for allogeneic transplants. Congratulations to these programs!

View the list of best hospitals in the cancer specialty

Enhancements to FACT’s Listing of Independently Accredited Collection Facilities

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

Accredited organizations are listed on the FACT website at The listing of independently accredited Collection Facilities now specifies collection site locations included in their FACT accreditation. The addition of the specific collection sites included in the accreditation will assure organizations seeking collection facilities that the location has been inspected and meets FACT Standards.

Collection Facilities may be accredited as part of a single transplant program (i.e. in relation to one Clinical Program) or independently of a program. When a facility is accredited under the umbrella of a single program(s), whether it is integrally part of the same institution or a contracted external facility, it must be inspected with each program it serves. The term “independent” indicates that the facility has been accredited to operate in relation to multiple programs, rather than in relation to one specific program.

The website of FACT-accredited organizations offers a variety of search functions, such as “Search by Name”, “Search by Cell Therapy or Cord Blood”, and “Search by Collection Type”. To search for an independently accredited Collection Facility, use the “Search by Service Providers” function. Drop-down options under this function include:

  • All Service Providers.
  • Cellular Therapy Processing Provider.
  • Marrow Collection Provider.
  • Peripheral Blood Collection Provider.

View the list of FACT-Accredited organizations on the FACT website

Virtual Inspections Lead to Accreditation Process Improvements

Posted in :: 2021 Volume 4, Uncategorized :: Wednesday, July 14th, 2021

By Suzanne Birnley, MS, MBA, FACT Accreditation Services Manager

It has been a very busy few months at FACT between the implementation of virtual inspections and publishing the eighth edition of the FACT-JACE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.  These developments have led to some changes and improvements to the FACT Accreditation Process.

  1. Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. All applicant programs and banks are now required to submit additional documentation in preparation for their FACT inspection. For applicants currently waiting for their inspection to be scheduled, these documents can be uploaded in the FACT Accreditation Portal Document Library under the Virtual Inspection Documents tab.  These documents are expected to be submitted a minimum of 4 weeks prior to the inspection. These additional submissions have been included with the Eighth Edition Hematopoietic Cellular Therapy (HCT) Compliance Application, and will be included in other Standards as new editions are published. These include:
    • A copy of all policies and Standard Operating Procedures referenced in the Quality Management Plan.
    • The most recently completed Annual Report on the Effectiveness of the Quality Management Program.
  1. Whether for a virtual inspection or on-site, beginning July 1, 2021, all programs are required to use OneNote or the equivalent to organize documents for their inspection. This can be accomplished in several ways:
    • Use the OneNote template provided by FACT.
    • Use a software developed within the organization or a commercially available software.
    • Use the FACT Self-Assessment Tool or checklist from your completed application in the FACT Accreditation Portal, and add additional columns for links to documents and information regarding where to find documentation of compliance for each standard.
    • For on-site inspections, use the binder method. Match each standard to the documentation of compliance in paper form, all organized by standard in three-ring binders.
  1. For virtual inspections, beginning July 1, 2021, all programs are required to use a document camera to display documentation that exists in paper format. This is particularly important in collection or processing facilities that use paper records.

Finally, it is very important that inspectors have access to any updated documents, especially if the Compliance Application was completed a year ago.  FACT Accreditation Coordinators will send Requests for Information (RFIs) to update documentation known to be out of date, such as medical licenses and continuing education.  It is your responsibility to let your coordinator know if there are any other policies or SOPs that were submitted that have since been revised.  If inspectors do not have access to these documents, it is a risk that they may not see evidence of compliance, resulting in deficiencies cited on the Accreditation Report.

FACT greatly appreciates the hard work of the inspectors and applicants as we transition through this challenging time.  We do intend to return to on-site inspections as soon as it is safe to do so.  We are actively seeking and welcoming feedback on both the virtual inspection process and these process changes.  If you have any questions or concerns, please contact your Accreditation Coordinator or the Manager of Accreditation Services, Suzanne Birnley.




Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 3)

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

How do you maintain audits, various consent forms, and other documentation?

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

Our quality management system, Q-Pulse, has been fantastic for maintaining audits, documents, non-conformances, supplies, equipment, and now training courses.  We are a central system overseeing 2 pediatric FACT-accredited sites and 12 nationally accredited sites (National Association of Testing Authorities, Australia/National Pathology Accreditation Advisory Council [NATA/NPAAC]). Without this tool, we would not exist. It automates actions, creates workflows, and emails notifications. I really like how easy it is to modify drop downs to meet our requirements without information technology upgrades or database changes. It is also very intuitive for staff, which makes training and day-to-day use very easy. I used to work for the national body, NATA, and I saw a lot of very complicated software packages-at accredited sites. Many were not well used!

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

Maintenance of audits, consent forms, and labeling is assigned to various quality designees, as applicable. Our programmatic Standard Operating Procedures (SOPs) describe established processes for follow-up and reporting to ensure the audits are completed in a timely manner. SOPs dictate processes for consent updating and review. Check-off and time-out processes ensure labeling is completed per standards and regulatory guidance. The quality designees work with physicians, supervisors, and clinicians to maintain compliance with FACT standards impacting the daily duties of staff members. The integration into daily practice creates a quality-focused program, with built-in and evolving checks and balances throughout the program’s departments to ensure consistency of processes and procedures.

Share strategies for staying up to date on upcoming changes to the Standards and what tools you use to communicate those upcoming changes within your organization.

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

Generally, this is done via Q-Pulse. We have had specific training sessions across our network, which have focused on donor work-up, ISBT 128 labelling, and GMP requirements.

An Immune Effector Cell (IEC) Quality Manager focuses purely on IEC rather than both Hematopoietic Progenitor Cell (HPC) and IEC. This has assisted in developing IEC-specific SOPs and processes. This is such a growing area that I believe it needs individual attention.

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

Monthly meetings are conducted to discuss regulatory topics, including any updates to the FACT Standards. Key personnel from the clinical, collection, and processing facilities participate in the monthly meetings. Consistent monitoring of the FACT newsletter and disseminating pertinent updates occurs during these meetings. Note, our programmatic SOPs outline how updates need to be conveyed to the program, reviewed with the FACT Program Director, and distributed to the program through an appropriate conduit based on the impact and urgency of the change.

Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation

Maintain a spreadsheet or utilize OneNote or a similar tool that crosswalks the FACT Standards to your SOPs. FACT provides an Excel download of all standards and related questions, called the Self-Assessment Tool, in the portal that can be used to prepare for the accreditation process. If a new edition of Standards is finalized during the organization’s accreditation cycle, organizations can use the crosswalk FACT provides to update its internal crosswalk to SOPs (available on the FACT website).

For additional information, download and view the educational recording, QM Series 8: The Document Control Process From Start to Finish (and Back Again!) (FACT), September 13, 2017.

Thank you to the following contributors for sharing their tips and lessons learned from their experiences at a FACT accredited program:

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

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

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

Register for the FACT-JACIE and WBMT Webinar: Quality and Accreditation for Cellular Therapy: A Global Perspective

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

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 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

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 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

How to Access the FACT Accreditation Report with Program Responses

Posted in :: 2020 Volume 9 :: Friday, December 11th, 2020

Some commercial cellular therapy product manufacturers may provide FACT-accredited programs the option to undergo a full site quality audit or provide a copy of the most recent FACT accreditation report and undergo an abbreviated audit. If choosing the second option, programs will want to provide manufacturers the final report complete with program responses to cited deficiencies. Program responses are an opportunity to demonstrate correction of deficiencies and ultimate compliance with FACT Standards.

FACT Accreditation Coordinators will provide a copy of the final Accreditation Report, with the program’s responses, when sending the Accreditation Certificate at the conclusion of the inspection and accreditation process. Additionally, in the current online accreditation portal, the complete report can be downloaded by opening the applicable Compliance Application and clicking “View: Accreditation Report” in the left navigation pane. A version of this report is also automatically saved in the Document Library when the accreditation process is complete.

Accessing the Accreditation Report in the legacy FACTWeb Portal

Not all programs have completed the accreditation process in the current online portal. For these programs, contact your FACT Accreditation Coordinator, who will be happy to email you a copy of the report.

Read more about the FACT Accreditation Report

FACT Virtual Inspections in Response to COVID-19

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT plans to begin virtual inspections this fall. There are many details to be finalized, however, the FACT Board of Directors has approved the plans outlined below. Thank you in advance for your flexibility and patience as we undertake this new process to protect the safety of our volunteer inspectors, personnel at accredited programs, and patients.

Eligibility for Virtual Inspections

Situations eligible for a virtual inspection include:

  • Renewal accreditation inspections of clinical, apheresis, or cell processing programs applying independently or together as a hematopoietic cell transplantation program, including immune effector cells.
  • Add-on service involving an existing accredited program (such as immune effector cells [IECs] or more than minimal manipulation processing).
  • Reinspection of all or a portion of a program following Accreditation Committee review of an in-person inspection, provided at least one member of the original inspection team participates in the virtual inspection, and there were no citations related to the physical integrity of the location itself.

Situations not currently eligible for a virtual inspection, and for which an on-site inspection is required, include:

  • Initial accreditation
  • Addition of an entirely new service in a new space, such as a pediatric program at a Children’s Hospital being added to an existing accredited adult program in another facility or a new current Good Manufacturing Practices (cGMP)-compliant processing facility added to an accredited transplant program.

In general, inspections will be either virtual or on-site, not a mixture. There may be exceptions. For example, an add-on to an existing program that is in the renewal process could have a virtual inspection for the renewal portion and an on-site visit of only the add-on portion (e.g., a cGMP facility for IECs added onto an accredited transplant program).

FACT is also working toward resuming some prioritized on-site inspections where these can be done in compliance with state, local, and CDC guidance and within facility and inspector restrictions.  This applies primarily to new applicants.

Prioritization of Virtual Inspections

Priority for virtual inspections will be given to cellular therapy programs whose on-site inspections were canceled, then to those who were in the process of scheduling when the on-site inspections were suspended in March 2020. Cord Blood Banks will begin virtual inspections slightly later.

All programs have been given an additional 6-month extension of their accreditation expiration dates as we resume inspections in this new way. This represents a total of a one year extension to the accreditation expiration.

Preparing for Virtual Inspections

Programs will receive direct individual communications regarding additional documentation that will be required either as an extra annual report or additional pre-inspection updates, depending on where they are in the accreditation cycle.

Please watch for communication from your FACT Accreditation Coordinator. You may contact your FACT Accreditation Coordinator for additional information and share this information with other appropriate individuals in your program, including apheresis and cell processing services. Your Accreditation Coordinator’s contact information can be found at

If you do not know who your coordinator is, contact Suzanne Birnley, Manager of Accreditation Services at

The Virtual Inspection Process

The platform for the interactive virtual inspections will be a FACT HIPAA-compliant ZOOM Healthcare account. There will be video tours expected, however, inspections will not be recorded. Video tours and additional documentation will be submitted through the FACT Accreditation Portal.

Cellular Therapy Program inspections will most likely occur over two days to allow both inspectors and program staff additional time to review and prepare additional documentation.

The Virtual Inspection Task Force is finalizing:

  • The list of additional documents that will be submitted in advance.
  • A list of documents that the program must be prepared to show to the inspector via ZOOM shared screen, which may include electronic documents such as SOPs, a portion of the EMR, or other scanned documents. Paper records may be shared via scanning or document or portable camera.
  • A list of items that will be demonstrated via a video tour of each site.
  • A proposed inspection agenda, including additional persons to be interviewed during the inspection, such as staff nurse, pharmacist, ICU / ER physician or staff.

Confidentiality of the Virtual Inspection

FACT has a Business Associate Agreement in place with each accredited and applicant program to cover confidentiality issues, including protected health information that may be viewed as part of the accreditation process, but is not recorded or retained by FACT or its volunteers.  FACT’s legal counsel has determined that the current Business Associate Agreement is sufficient to safeguard the virtual inspection process. FACT will work with any institution individually if there are concerns. All FACT staff and volunteers annually sign Confidentiality and Conflict of Interest Agreements.

In addition, the virtual inspection process will incorporate practices to enhance confidentiality, such as requirement for a private room for the inspector to conduct the inspection and lack of recording of the inspection.

Frequently Asked Questions

In addition to questions directly related to accreditation, FACT continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is periodically updated and is available on the FACT website. Topics include:

  • Rescheduled inspections
  • Renewal process
  • Allogeneic transplant numbers
  • Relocating transplant patients
  • Deviations
  • Care adjustments related to COVID-19

If you have further questions or concerns, please contact Dr. Phyllis Warkentin [ or 402-559-6781],  the FACT office (402-559-1950), or your FACT Accreditation Coordinator.

Other Resources Available:

ASTCT Resources
WMDA Resources
Centers for Disease Controls
World Health Organizations

FACT Accreditation Reports Promote Internal Improvement and External Confirmation of Quality

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT accreditation is a credential that has its greatest value in the peer-to-peer exchange of ideas to confirm and improve quality in patient care and laboratory services. Successful accreditation is awarded with two tangible items: an Accreditation Certificate and a final Accreditation Report. Although the certificate gets more prominence, often framed and mounted as a visual symbol of quality, the final report is a detailed accounting of what accredited programs implemented to reach compliance with all FACT Standards.

Each Accreditation Report provides important information related to an accredited program’s journey to initial or renewal accreditation. The final report includes:

  • The name and location of the program
  • The date of the on-site inspection
  • The clinical, collection, processing, and/or banking sites and services associated with the accreditation
  • Key personnel
  • Identification of the FACT inspection team
  • A description of the program
  • Deficiencies and variances cited by the inspection team and approved by the Accreditation Committee
  • Required responses to provide evidence of correction of each deficiency or acknowledgement of each variance
  • The program’s responses documenting completion of corrective actions and compliance with Standards
  • FACT’s response, or determination regarding the adequacy of the program’s corrective action
  • Details of any additional follow up reports or documentation due to FACT

After completing the rigorous accreditation process, programs may debrief the contents of the Accreditation Report and then file it away, turning attention to its many other important duties until annual reporting is required. However, the final report is a valuable tool that can be used throughout the accreditation cycle.

Internal Improvement

Programs that have corrected deficiencies and submitted adequate evidence of correction and compliance with standards should be very proud of the work they have invested into improvement. Lessons learned throughout this process can be applied to the entire program. For example:

  • How will we evaluate our corrective actions to confirm long-term effectiveness?
  • What other strengths and weaknesses did we discover while correcting deficiencies?
  • Are there further root cause analyses we should perform to prevent similar deficiencies?
  • Can we apply the same process to evaluate other aspects of our program?

Ideas generated from this review of the Accreditation Report may be useful to maintaining the Quality Management program via audits, process development, personnel training, and other quality concepts.

External Confirmation of Quality

Apheresis collection facilities, cell processing facilities, and clinical services are each important in the context of blood and marrow transplantation, where accreditation covers the entire scope of the therapy from patient selection and treatment, through product selection, collection, processing, and administration. These same services participate in clinical trials often including products developed and manufactured by industry partners. These facilities recognize the importance of standards, have achieved voluntary FACT accreditation, and have played a major role in delivering new products to patients. They have used their quality programs and processes to quickly adapt to increasing numbers of products, procedures, and manufacturers. However, facilities have individually and collectively expressed concern regarding the growing number of on-site audits. The increased burden of preparing for, participating in, and responding to audits requires more resources to be diverted to these activities rather than toward patient care.

Commercial manufacturers who produce cellular therapy products for clinical trials or under an approved regulatory license may wish to leverage FACT accreditation to streamline audit activities, verify quality practices, and reduce the burden on health care entities. To do this, manufacturers may request a copy of the final FACT Accreditation Report. FACT does not provide Accreditation Reports to any entity except the accredited program. Accredited programs are not restricted from sharing these reports and may choose to provide them to manufacturers leveraging FACT accreditation, however, they are not required to do so.

Accredited programs or their hospital administration may be hesitant to disclose deficiencies cited during an on-site inspection. However, FACT accreditation is a voluntary, peer-based quality improvement process, during which  some deficiencies can be expected at any program. The documented deficiencies demonstrate the rigor of the inspection process. The final report includes the description and documentation of the program’s corrective action, FACT’s determination of the adequacy of the response, and any additional follow up that may be indicated.  Responses to deficiencies are an opportunity to proudly share a program’s process improvements. Programs should inquire of any commercial manufacturer regarding the confidentiality of information they provide to increase confidence in the use of the FACT report.

If a program chooses to provide the final Accreditation Report to a commercial manufacturer, it will likely be able to participate in an abbreviated site audit because the Accreditation Report can be used to confirm the quality systems in place meet FACT Standards. If a program chooses not to provide the report, it may be required to undergo a full site audit that will include requirements duplicative to the FACT Standards.