FACT’s Board of Directors honored Dr. Mark Litzow for his contributions to our organization. Dr. Litzow most recently served on the FACT Board from 2011 – 2019. As a FACT Inspector, Dr. Litzow has performed 30 clinical inspections over the last 20 years!
Mark was appointed as the inaugural chair for FACT’s Technology Committee and served since 2009 – 2019. Dr. Litzow’s charge as Chair of the Technology Committee was to enhance, refine, streamline and improve the efficiency of the accreditation process and educational programs through the continued development of FACT’s online presence. Mark has survived the development of two accreditation portals!
Through Dr. Litzow’s leadership, the Technology Committee:
- Launched the first FACTWeb Portal automating the accreditation process.
- Launched the new FACT Accreditation Portal to replace FACTWeb and better position FACT for long term success.
- Evaluated features to enhance the user’s accreditation portal experience including an improved document library experience and the addition of an inspector trainee feature within the portal allowing trainees to get firsthand experience within the portal.
- Developed online training materials for accreditation portal users.
- Improved the online accreditation application including the Eligibility and Compliance application.
- Continued to provide training for users of the accreditation portal.
Mark your contributions have been invaluable and you have certainly left us as a stronger organization. You will be greatly missed!
Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT
Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present Labeling and Chain of Identity and Custody for IEC Products. Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside. In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.
Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT
Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program. Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy. He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.
FACT Cord Blood Inspection & Accreditation Workshop
September 9, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.
Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge!
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the applicant and inspector training track!
FACT announces new educational opportunities for collection, processing, cord blood, and clinical cellular therapy colleagues. FACT representatives will be in attendance for all upcoming workshops to provide examples, discuss challenges, and answer questions.
All upcoming events will have a separate track for inspector trainees. Workshops include:
- FACT Cellular Therapy Collection Workshop at the 2019 ASFA Meeting
- FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
- ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting
- FACT Cellular Therapy Inspection and Accreditation Workshop at the Canadian Bone Marrow Transplant Group Annual Meeting
- WMDA-NetCord & FACT Cord Blood Day at the Cord Blood Connect International Congress
Memorandum of Understanding Signed by FACT and SBTMO to Develop Joint Accreditation Program in Brazil
The Foundation for the Accreditation of Cellular Therapy (FACT) and the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO), the Brazilian Society of Bone Marrow Transplantation, have announced its formal partnership to develop a joint FACT-SBTMO Cellular Therapy Accreditation Program in Brazil.
The agreement, in the form of a Memorandum of Understanding (MoU), formalizes the mutual interaction and strengthens the existing relationship between the SBTMO and FACT at the strategic and working level, focusing on standardization and accreditation of cellular therapy in Brazil.
Dr. Nelson Hamerschlak, SBTMO President states, “This partnership will bring a higher level of quality and outcomes for all Brazilian bone marrow transplant centers.” Dr. Hamerschlak leads the Hospital Israelita Albert Einstein (HIAE) in Brazil, the first Bone Marrow Transplantation Center in Latin America to receive FACT accreditation. HIAE is accredited for autologous and allogenic transplantation and cord blood banking.
For over 20 years, FACT has established international standards for hematopoietic cellular therapy product collection, processing, and administration. FACT administers its accreditation program in 25 countries. “The collaboration between FACT and SBTMO will support efforts to improve quality and patient safety at cellular therapy programs in Brazil in accordance with FACT-JACIE Standards,” said Linda Miller, FACT Chief Executive Officer.
“Through this partnership, FACT and SBTMO will work to increase access for patients to internationally accredited blood and marrow transplant programs in Brazil,” states Dr. Dennis Gastineau, FACT President.