Accreditation Statistics

As of May 2, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Abu Dhabi Stem Cell Center, Abu Dhabi, United Arab Emirates | Cellular Therapy Product Processing with Minimal Manipulation
  • CHN - Complexo Hospitalar de Niterói, Rio de Janeiro, Brazil | Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and  Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

     

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

Introducing FACT Audit & Assessment Services: Streamlining Site Assessments for Enhanced Patient Access

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

By Shawn Phillips, FAAS Auditor

We are excited to announce the official launch of FACT Audit & Assessment Services (FAAS), a new solution provided by FACT Consulting Services aimed at improving site assessments in the cellular therapy industry. Our mission is simple: to optimize patient care and enhance access to cellular therapies by streamlining the auditing process for all stakeholders involved.

In response to the growing demand for efficient assessment solutions in the rapidly evolving landscape of cell and gene therapy products, FAAS offers a new approach. Our services are designed to rapidly evaluate sites’ capabilities, facilitating their integration into companies’ networks while significantly reducing the burden of duplicative audits on healthcare sites.

FAAS is positioned to provide a singular, comprehensive assessment of collection and/or treatment sites via an assessment process that will become familiar to sites, providing a single audit summary report that can be leveraged by multiple companies.

Why FAAS Matters

With the development of numerous cell and gene therapy products, the need for qualified sites has never been more urgent. FAAS addresses this need by offering:

  • Efficiency: Our streamlined assessment process saves time and resources for both healthcare sites and industry players, allowing them to focus on delivering cutting-edge treatments to patients.
  • Quality Assurance: FAAS verifies that sites meet quality standards and regulations, providing assurance to companies and patients alike.
  • Enhanced Patient Access: By reducing the audit strain on industry sites, FAAS enables them to serve a broader patient population, ultimately advancing the goal of improving patient outcomes.

Why FAAS Can be the Ultimate Solution

  • Proven Process: Our methodologies are based on the globally trusted FACT accreditation program for cellular therapy, providing comprehensive evaluation and guidance for corrective actions.
  • Optimizing Access: We utilize consistent audit and assessment procedures and leverage existing reports to reduce the burden of repetitive audits, accelerate site qualification, and enhance access to cellular therapy for patients.
  • Tailored Programs: We design audit and assessment programs tailored to clients’ specific needs, whether it’s scope, geography, frequency, or number of sites.
  • Balanced Approach: We strike a balance between standardization and customization, optimizing quality at non-accredited sites and leveraging existing FACT accreditation to streamline audits.
  • Addressing Challenges: Say goodbye to unclear requirements and resource allocation issues. Our services alleviate the time, workforce, and financial burden of site certification on both health care sites and industry.

Meet Our Team

Leading FAAS is Liz Ferraro, Manager of Audit and Assessment Services. She is a seasoned Quality Manager with over 30 years of experience in healthcare quality management. With a proven track record at Nebraska Medicine Apheresis Program and LifeNet Health, Liz brings a wealth of expertise to her role.

 

 

 

 

Shawn Phillips, FAAS Auditor, is a quality auditor with a clinical background in Nuclear Medicine. His experience at Roswell Park Comprehensive Cancer Institute uniquely positions him to contribute to FAAS’s mission of ensuring site excellence.

 

 

 

 

How You Can Help

We invite programs and healthcare professionals to join us in spreading the word about FAAS. By recommending FAAS to companies seeking to conduct audits, you not only support the advancement of innovative treatments but also contribute to expanding patient access to these life-changing therapies. Companies can initiate the process of developing a customized assessment program via the Needs Assessment Form on the FACT Consulting Services website. Feel free to share this link!

FAAS represents a pivotal step towards optimizing site assessments and enhancing patient access to groundbreaking treatments. Together, let’s propel the healthcare industry forward and make a meaningful difference in patients’ lives.


Knowledge Makes All the Difference

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

With the addition of two new consultants, FACT Consulting Services now has ten experts in the field of cellular transplant therapy and cord blood banking with a combined total of over 300 years of experience and over 200 FACT inspections or audits!

Meet our newest expert consultants:

 Sue Armitage, BSc Sue has over twenty years of experience in the stem cell field with 20 years specializing in cord blood banking.  She participated in the initiation and development of the NetCord-FACT International Standards for Cord Blood Banking.  Her professional responsibilities at the NHS London and University of Texas MD Anderson Cord Blood Banks have included design, development, expansion, operation and improvement of all cord blood banking activities and systems, from donor recruitment through release for transplant; ensuring daily operation within the regulatory requirements in both the UK and US.  Sue established and managed a stem cell laboratory within the National Blood Service, providing clinical service to local London hospitals, including stem cell assays and cryopreservation.  She presented at over 30 national and international conferences and was an instructor for 12 FACT cord blood bank workshops and for postgraduate courses in transfusion medicine and cord blood banking.  Sue has performed 18 FACT inspections for Cord Blood Banking and has served on several FACT committees including the NetCord-FACT Standards Committee, the FACT Education Committee, and the FACT-NetCord Accreditation Committee.

Carolyn Keever-Taylor, PhD
Dr. Taylor has over 34 years of experience in the field of hematopoietic progenitor cell (HPC) transplantation, transplant immunology, and cellular therapy.  She holds a PhD in Microbiology and Immunology from Wake Forest University and was a Research Fellow and Research Associate under Dr. Richard J. O’Reilly at Memorial Sloan-Kettering Cancer Center.  She served as the Cell Processing Laboratory Director at Ohio State University (3 years) and at the Medical College of Wisconsin (MCW) for the subsequent 26 years.  She was appointed Director of the Lymphocyte Propagation Laboratory at MCW in 1996.  Dr. Taylor was a founding member of the International Society for Cellular Therapy (ISCT) where she served on the Board of Directors.  Dr. Taylor served on the FACT Board of Directors (2008-2015) including two years as Vice President. As a FACT inspector, Carolyn has performed 38 FACT inspections.  She has chaired the FACT Standards Committee and has served on the Cell Processing Standards Committee. Dr. Taylor has participated as faculty in 25 FACT Cellular Therapy Inspection & Accreditation Workshops.  She has also served as a member of the FACT Accreditation Committee for the past 12 years.  She served on the FACT Regenerative Medicine Taskforce and was a primary author of the FACT Common Standards.  In addition, Dr. Taylor has served as a member (1993-present) and on the Board of Directors (2011-2014) for the American Society for Blood and Marrow Transplantation (ASBMT).  She also served as the FACT Representative to the Worldwide Network for Blood and Marrow Transplantation (WBMT) and member of the WBMT Executive Committee from 2009 to 2016.  Dr. Taylor has been a member of the American Society of Hematology (ASH) since 1984 where she has served on Abstract Review Committees as a member or coordinating reviewer.                           

Our consultants can help you reach your goals for better patient care and improved patient outcomes by using their knowledge and experience with the peer-developed standards, education, and the accreditation process.

No matter what your needs,  if you are starting  a clinical program, processing facility, or cord blood bank, or you need help maintaining  or reaching your outcome and quality goals, we have the expertise you need.

Visit our website, FACT Consulting Services, to meet the FACT Consultants.

Article written by Judy Anderson,MA, MT(ASCP)SI, FACT Consulting Services


Consulting Services

Posted in :: 2016 Volume 2 :: Wednesday, October 12th, 2016

FACT Consulting Services, a subsidiary of FACT, offers a fee-for-service resource that matches client organizations with a consultant that meets their specific needs.

FACT recognizes that each cell therapy program is unique, and its needs are always evolving. We understand that there will be seasons when you have all the skills and experience necessary for quality management and accreditation readiness, and that there will be other times when help is needed or prudent. In those instances, program depth and breadth can be gained through experienced FACT consultants.

The FACT Consulting Menu of Services has been expanded to meet the growing demands of the cell therapy field and includes but is not limited to:

  • Compliance Assessment
  • Policy Review
  • Policy Development
  • Application Assembly
  • Mock Desktop Review
  • Mock On-Site Inspection
  • Continuous FACT-Readiness
  • Quality Management
  • Training Workshops

If you don’t see a service that meets your exact needs in the list above, please explain your unique situation and opportunities to us. We know that transplant centers, cord blood banks, and regenerative medicine programs vary in volume, size, structure, and markets. Therefore, customized services are essential to meet specific needs. Chances are the necessary experience can be found among our consultants for the services that you need.

We are here to help and the place to begin is a phone call (402.559.1185). You will have the chance to explain the challenges and opportunities that your organization is facing and the outcomes that you want to achieve, and she will help you identify and select the services most beneficial for your organization’s needs.  For more information, visit the FACT Consulting website.