King Abdulaziz Medical City – Riyadh, Saudi Arabia is first Cellular Therapy Program in Saudi Arabia to earn FACT Accreditation
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-SBTMO Joint Accreditation Program Launched in Brazil
SBTMO President, Dr. Nelson Hamerschlak, pictured with Dr. Phyllis Warkentin and Dr. Carlos Bachier.
Approximately 70 representatives of bone marrow transplant centers attended the FACT-SBTMO Accreditation Program Workshop on July 31, 2019; an initiative that is the result of the partnership between the Brazilian Society of Bone Marrow Transplant (SBTMO) and the Foundation for the Accreditation of Cellular Therapy.
The meeting clarified the requirements and the operational dynamics of the accreditation process for Brazilian cell therapy transplant centers.
As Carlos Bachier and Phyllis Warkentin of the FACT Global Accreditation Committee have reported, it may seem complex at first, but it is certainly possible to complete each of the gradual steps in the process toward accreditation.
The accreditation will be valid for 3 years. The estimated time to complete the initial certification cycle is 2 years. The program was designed taking into account the structure and operations of the Brazilian centers, including the interest of the 39 TMO centers that responded to the SBTMO Online Survey distributed to gather the demographics of the national transplant programs.
For over 20 years, FACT has established international standards for the collection, processing and administration of hematopoietic cell therapy products. It is worth mentioning that Brazil was the pioneer in Latin America when in 2012 Hospital Israelita Albert Einstein (HIAE) was awarded FACT accreditation. Albert Einstein has been re-accredited in 2015 and 2018.
In addition to Brazil, FACT has accredited 255 cell therapy programs in 6 countries: Canada, Mexico, New Zealand, Australia, Singapore, United States.
It is noteworthy that FACT accreditation is based on the FACT-JACIE (The Joint Accreditation Committee ISCT-Europe & EBMT) Standards, which is Europe’s only official accreditation body in the field of HSCT and cell therapy.
Expression of Interest
If you wish to express your interest in joining the accreditation program in Brazil, please send the following data to SBTMO – via contato@sbtmo.org.br or FACT – via fact@unmc.edu
Data
- Transplant Center Name
- Name of Contact Person
- Full address
Put in the subject line of the message : “FACT-SBTMO Accreditation”
Upcoming Educational Events
FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR
Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:
• Overview of FACT Accreditation Processes
• Common Citations Overview
• Integration of Immune Effector Cells into Accreditation
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Risk Evaluation and Mitigation Strategies (REMS)
• How to prepare for and conduct inspections
• Data Management
• Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management, personnel, and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
Register for the FACT workshop
Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
View meeting details and register
Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
Houston, TX
If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
View meeting details and register online
View workshop agenda
FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas
Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.
This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.
View meeting details and register
View Quality Boot Camp agenda
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX
The Foundation for the Accreditation of Cellular Therapy (FACT) invites international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.
View meeting details and register
FACT Inspectors are Invited to Social Hour during TCT Meetings
In honor of their dedication and service provided to the cell therapy community, FACT Inspectors are cordially invited to attend the FACT Inspector Social Hour on Friday, February 22, 2019 at the Hilton Americas-Houston Hotel, Room 335B from 5 pm – 6 pm. Light hors d’oeuvres and cocktails will be provided.
Visit FACT at Exhibit Booth 2254!
During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.
Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.
2019 TCT Exhibit Booth Hours:
Wednesday, February 20
7:00 a.m. – 2:00 p.m.
Thursday, February 21
7:00 a.m. – 2:00 p.m.
Friday, February 22
7:00 a.m. – 1:00 p.m.
Saturday, February 23
7:00 a.m. – 1:30 p.m.
QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar
This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.
FACT Cellular Therapy Collection Workshop at 2019 Annual ASFA Meeting
May 15, 2019
Portland, Oregon
Join FACT on Wednesday, May 15, at the Hilton Portland Downtown in Portland, OR, for a workshop designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities.
FACT representatives will be in attendance to discuss cellular therapy collection challenges, provide examples on how to maintain quality when faced with different collection protocols, and present a common citations overview. This workshop also includes inspector trainee sessions on how to perform a FACT inspection from start to finish.
View meeting details and register
FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
Melbourne, Australia
This workshop will provide well-rounded information on the process of accreditation, requirements in the FACT Standards, and how immune effector cellular therapy fits within the realms of cellular therapy and cord blood banking. This event is a must-see opportunity for the following audiences.
- Blood and marrow transplant (BMT) programs
- Cord blood banks
- Cell processing laboratories
- Physicians, scientists, and principal investigators
- Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
- Quality managers
Separate tracks will be available for cellular therapy programs and cord blood banks, followed by training specific to inspector trainees.
View meeting details and register
ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting Pre-Conference Day
May 29, 2019
Melbourne, Australia
Is your cell processing facility FACT accredited or looking to comply to FACT standards? Strengthen your quality assurance program through this interactive workshop with FACT experts and real world applications.
Focused on issues identified by FACT-compliant transplant programs, these sessions will include activities and discussion in four main topic areas. Come prepared with your quality program questions and leverage quality experts to identify process improvement opportunities you can apply at your organization.
View information and register for ISCT pre-conference day
FACT Cellular Therapy Inspection and Accreditation Workshop at CBMTG Annual Meeting
June 5, 2019
Calgary, Alberta, Canada
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including:
o Overview of FACT Accreditation Processes
o Common Citations Overview
o Integration of Immune Effector Cells into Accreditation
o Using the Tracer Methodology to Assess Compliance with FACT Standards
o Risk Evaluation and Mitigation Strategies (REMS)
o How to Prepare for and Conduct Inspections
o Data Management
o Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
View meeting details and register online
WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL
Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the 2019 WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 12, 2019, in conjunction with the Cord Blood Connect International Congress.
The WMDA-NetCord & FACT Cord Blood Day will highlight recent advances in cord blood transplantation and include global perspectives of cord blood transplants, common FACT-NetCord inspection citations, and more. The afternoon consists of two breakout sessions: a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Registration fees are waived for FACT active and trainee inspectors. Apply to be a FACT inspector!
View meeting details and register online
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
FACT International Accreditation
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.
Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements. Register to attend!
Upcoming Educational Events
Exceptional Release of Commercial Cellular Therapy Products
January 30, 2019
Webinar
Join FACT on January 30, 2019, at 11:00 am ET, 1600 GMT, for a webinar titled, Exceptional Release of Commercial Cellular Therapy Products. Autologous cellular therapy products can be irreplaceable, and exceptional release of nonconforming products may be necessary to the well-being of patients. FACT-accredited programs are increasingly using autologous products that are licensed by regulatory authorities, and sometimes these products do not meet specifications. In this webinar, presenters will discuss FACT requirements for exceptional release, and then share their centers’ processes for release of nonconforming commercial cellular therapy products in the United States.
Webinar presenters include:
Dr. Phyllis I. Warkentin, Chief Medical Officer of FACT
Dr. Premal Lulla, Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Dr. Elizabeth Shpall, MD Anderson Cord Blood Bank Medical Director, MD Anderson Cellular Therapy Transplant Program Director, and co-director of the MD Anderson CARTOX program.
Dr. Phillip McCarthy, of Roswell Park Comprehensive Cancer Center – Transplant and Cellular Therapy Program for Adult Inpatient, Outpatient, and Pediatric Outpatient Programs – John R. Oishei Children’s Hospital
Validation Principles and Protocols for Cellular Therapies
February 6, 2019
Webinar
Join FACT for a webinar, Validation Principles and Protocols for Cellular Therapies, on Wednesday, February 6, 2019, at 11:00 am ET, 16:00 GMT. Dr. Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic Health Center, will discuss the Validation Principles and Protocols for Cellular Therapies, and the FACT-JACIE Seventh Edition Standards requirements.
FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR
Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:
• Overview of FACT Accreditation Processes
• Common Citations Overview
• Integration of Immune Effector Cells into Accreditation
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Risk Evaluation and Mitigation Strategies (REMS)
• How to prepare for and conduct inspections
• Data Management
• Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management, personnel, and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
Register for the FACT workshop
Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
View meeting details and register
Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
Houston, TX
If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
View meeting details and register online
FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas
Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.
This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.
View meeting details and register
View preliminary agenda
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.
Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.
View meeting details and register
Visit FACT at Exhibit Booth 2254!
During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.
Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.
2019 TCT Exhibit Booth Hours:
Wednesday, February 20
7:00 a.m. – 2:00 p.m.
Thursday, February 21
7:00 a.m. – 2:00 p.m.
Friday, February 22
7:00 a.m. – 1:00 p.m.
Saturday, February 23
7:00 a.m. – 1:30 p.m.
QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar
This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.
Global Affairs
FACT continues to develop its international collaborations through regional initiatives aimed at providing educational assistance and accreditation activities tailored to the needs of the global communities.
FACT-JACIE Stepwise Accreditation in Latin America
In an effort to provide an incremental approach to accreditation, FACT and JACIE have partnered to offer a stepwise accreditation program in Latin America. This stepwise approach to accreditation would enable programs to focus on their quality systems first and ensure operations for patient and donor safety. The second phase would build on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes. The first FACT-JACIE Stepwise Inspection is scheduled to be conducted in Argentina on November 20-21, 2018.
India
A broad group of ten participating bone marrow transplant centers throughout India is participating in the new India Working Group 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.
Asia-Pacific
A FACT Standards and Accreditation Workshop was held on November 2, 2018 during the annual meeting of the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) in Taipei, Taiwan. Presentations included the importance of integrating a quality management system throughout the clinical, collection and cell processing activities; the accreditation experience of the National University Health System in Singapore; the incentives for seeking international accreditation from the Tata Medical Center in Kolkata; and the need for standardization and accreditation in China.
Brazil
Following the execution of a formal Memorandum of Understanding (MoU) in August, FACT and the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) created a FACT-SBTMO Task Force. The first meeting of the Task Force was conducted on October 17, 2018 to review the strategic goals and operational aspects of the joint FACT-SBTMO Accreditation Program. A survey of the Brazil transplant centers will be distributed in November to gather data related to the volume and type of transplants performed, program structure, personnel, facilities, and quality management systems. The information will be used to identify areas of educational need and ascertain readiness for accreditation.
