Accreditation Statistics

As of June 3, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Cord Blood Bank University Hospital Basel Cord Blood Collection (Fixed and Non-Fixed sites), Banking, and Release for Administration of Unrelated and Related Donations
  • Cord Blood Bank Geneva Cord Blood Collection (Fixed, Non-Fixed sites), Banking, and Release for Administration of Unrelated and Related Donations

     

A complete list of accredited organizations can be found at https://accredited.factglobal.org/.

Abu Dhabi Stem Cells Center is First Cellular Therapy Processing Facility in United Arab Emirates to Earn FACT Accreditation

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

Abu Dhabi Stem Cells Center (ADSCC) has achieved internationally recognized accreditation from FACT, making it the first and only cellular therapy processing facility in the United Arab Emirates to earn this distinction. Led by Prof. Yendry Ventura, MD, ADSCC received accreditation on April 2, 2024, specifically for Cellular Therapy Processing with minimal manipulation.

Prof. Yendry Venturay, CEO of ADSC and Adjunct Professor at UAE University, expressed his gratitude, commenting, “Under the guidance of UAE’s wise leadership and in line with the UAE’s national agenda in healthcare, ADSCC has a clear vision and mandate of pioneering cellular therapy on a global scale and bringing medical breakthroughs close to bedside, which plays a crucial role in positioning Abu Dhabi and the UAE at the vanguard of healthcare innovation. With this landmark FACT accreditation, we are breaking new ground in addressing complex diseases through cutting-edge treatments such as stem cell transplants and other cellular therapies. The journey towards accreditation has been both extensive and stimulating, and we take immense pride in being the first institution in UAE to receive it. This achievement reaffirms our commitment to continue investing in providing the highest standards of patient care and offering top-tier cellular therapy services that is on par with the best globally.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, commended ADSCC, stating “FACT accreditation represents a commitment to quality throughout an organization and requires dedication and perseverance. I congratulate Prof. Ventura and the team of the Abu Dhabi Stem Cells Center on achieving FACT accreditation, the first cellular therapy product processing laboratory in the United Arab Emirates to reach this milestone.”


Register for Upcoming FACT Education Events!

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

AUGUST

SEPTEMBER

 

View the Full Educational Library and Upcoming Events at https://learn.factglobal.org/


Tata Medical Center is First Cellular Therapy Program in India to Earn FACT Accreditation

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

FACT is pleased to announce that Tata Medical Center in Kolkata, India, received internationally recognized FACT accreditation. Directed by Jeevan Kumar, MD, MBBS, it is the first and only cellular therapy program in India to be recognized by FACT. Dr. Mammen Chandy, former Director of Tata Medical Center, committed years ago to enhancing quality throughout the program and attaining FACT accreditation. The program achieved accreditation February 29, 2024, for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation. Tata Medical Center is part of the FACT India Working Group, led by Nadim Mahmud, MD, PhD.

Dr. Mahmud states, “This marks a significant milestone for the FACT India Working Group and for India. We are encouraged by Tata Medical Center’s achievement in obtaining FACT accreditation, which demonstrates a commitment to quality and ensuring the best possible outcomes for patients undergoing stem cell transplants. We believe that other transplant centers in India will recognize the benefits and join us in pursuing FACT accreditation. I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom in facilitating the process and advocating the need for FACT accreditation, not only for Tata Medical Center in Kolkata, but for all BMT centers in India.”

Dr. Kumar notes, “The FACT accreditation cements our commitment to provide the highest quality of patient care. It is recognition of our founding director’s vision to establish evidence based best practices in cellular therapy at Tata Medical Center. The unwavering support of the administration and our team’s hard work has resulted in successfully completing the accreditation process. It marks the inclusion of the first Indian center into the global consortium of accredited institutions. Even though the accreditation process was rigorous, it helped us to consolidate our strengths and identify opportunities for improvement. The FACT team has continuously supported us in this endeavor. The on-site inspection served as a peer-review by international experts and boosted the morale of our team members. As an active member of the FACT India Working Group, we are happy to share our experiences and quality improvement initiatives with like-minded centers in India and abroad.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Tata Medical Center’s achievement of FACT accreditation in Hematopoietic Cell Transplantation and Cellular Therapy as the first program in India to reach this milestone demonstrates its commitment to providing quality care for the patients it serves. FACT commends the leadership and staff of Tata Medical Center for their dedication and resilience in pursuit of accreditation, their contributions to the FACT India Working Group, and their leadership in the field and the region.”


FACT India Working Group

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

By Nadim Mahmud, MD, PhD
University of Illinois College of Medicine, Chicago

India has a population of more than 1.4 billion, and about 105 bone marrow transplant (BMT) centers performing approximately 2,000 stem cell transplants annually. In North America, Europe, or Australia there are more than 300 transplants performed per 10 million people. Based on this transplant utilization number, India may need to perform about an estimated 39,000 transplants per year. Since only 2,000 transplants are performed, a gap of 37,000 transplants per year exists. Thus, there remains a huge gap in capacity to perform BMT for its population need. On the other hand, even for 105 existing BMT centers, there is a notable lack of trained transplant physicians, nurses, and quality managers.

The first BMT center in Vellore was established in 1986 (Christian Medical College), yet there had been no FACT-accredited transplant centers in India until recently. During one of my visits to the Haematocon (Indian Society of Haematology & Blood Transfusion) meeting in Bangalore, I had an informal meeting with Dr. Mammen Chandy. Dr. Mammen is also the pioneer in establishing the first BMT center in India. This conversation led to an informal visit to Tata Medical Transplant Center in Kolkata in 2017.

Since 2012, FACT has attempted to actively engage with transplant centers in India. FACT offered a workshop during the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) Congress held in Hyderabad, India , outlining the benefits and scope of FACT accreditation. The FACT India Working Group (IWG) was formed in 2018 to encourage BMT centers to attempt to take part in the FACT accreditation process. A broad group of ten participating centers from various parts of India is participating in the IWG designed to address the regional needs of the country. The centers are completing self-assessments of their programs to identify any potential barriers to compliance with FACT Standards, clarify the intent of requirements, and assess their readiness for accreditation. Tata Medical Center (Kolkata) is one of the active participants in IWG.

Having BMT programs accredited by organizations like FACT would facilitate a standard quality management program outlining policies, procedures, and deviation management. Such awareness can greatly improve patient care and transplant outcomes. Having a stringent quality management program and data sharing among peer transplant groups would enable establishing outcome benchmarks to stride towards overcoming barriers.

This year, the Tata Medical Center in Kolkata is the first ever BMT center in India to be awarded FACT accreditation. This is a huge milestone for having a BMT program with an established quality management program.  There are only two other FACT-accredited BMT centers in Asia: one in Singapore and one in Saudi Arabia. As the FACT IWG chair, along with the working group’s staff liaison Sarah-Litel Smith (FACT Accreditation Supervisor) and the FACT office, we are encouraged to see interest in achieving FACT accreditation and thus fulfilling a commitment to patients undergoing stem cell transplants anywhere to have the best outcomes possible. We firmly believe that other transplant centers in India will see the benefits and join this endeavor to achieve FACT accreditation.

This was only possible due to the tremendous support and faith from the FACT Chief Operating Officer, Ms. Linda Miller, and Chief Medical Officer, Dr. Phyllis Warkentin, for IWG to carry on despite slow progress at the beginning. Personally, I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom facilitating the process and advocating the need for FACT accreditation not only for Tata Medical Center but for all BMT centers in India. FACT is also grateful to the organizers of Haematocon, the annual conference of the Indian Society of Haematology and Blood Transfusion (ISHBT), for facilitating FACT Quality workshops over the years.


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 https://www.factglobal.org/inspectors/.

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 fact@factglobal.org.


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 fact@factglobal.org, 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 http://www.factwebsite.org/. 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 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