By Mikaela VanMoorleghem, FACT Education and Training Coordinator
FACT Events at ISCT Were a Success!
Chrissy Gordon: A Patient Perspective
FACT was honored to have its Cellular Therapy and Cord Blood Inspection and Accreditation Workshop in Melbourne, Australia opened by Ms. Chrissy Gordon, a recipient of an unrelated bone marrow transplant in 2000. Chrissy’s inspirational story of diagnosis, treatment, transplant, challenges, and successes over the past twenty years highlighted the importance of continuing to pursue improvements in the quality of patient care and advancing the promising developments in the field of cellular therapy. Diagnosed with leukemia in 1999 at the age of 28, Chrissy was treated in Melbourne, but her matched donor was found half way around the globe in Omaha, Nebraska where the donation was made at the University of Nebraska Medical Center. We first met Chrissy when she and her husband Dave visited Omaha to celebrate the 70th birthday of her marrow donor, Mr. Ken Vice of Lincoln, Nebraska.
ISCT-FACT Quality Boot Camp 2019
The 2019 ISCT Annual Meeting in Melbourne kicked off during the Pre-Conference Day with a packed house at the ISCT – FACT Quality Boot Camp on Wednesday, May 29, 2019. Patrick Hanley, PhD presented timely information on incorporating immune effector cell activities into existing quality management programs. Guy Klamer, PhD discussed the importance of document control and common issues faced by cord blood banks. Participants were actively engaged during an interactive session with Phillip Johnson on risk management, and were presented with several case scenarios and asked to assess the risk. With validations being an important and challenging component of every cellular therapy facility, Robyn Rodwell, PhD and Annette Tricket, PhD provided details on the validation process and examples of their organizations’ results. FACT’s Quality Manager, Heather Conway, addressed the important subject of auditing, focusing on the minimum requirements of an audit report and the “Five Whys.” The day concluded with a hands-on exercise using the ISBT 128 Audit Tool for Cellular Therapy. The day was a great success and we look forward to future quality boot camps discussing core quality topics valuable to your organization. If you have ideas for future quality sessions, email your ideas to FACT@UNMC.edu.
Help FACT Design Education Just for YOU
We would like to hear from YOU! FACT wants to provide the education that you need. Please help us develop education that is tailored to fit your needs by filling out this short 3-question survey.
Complete the Education Suggestions survey.
Webinar Series on Implementing Commercial CAR T-cell Products
The American Society of Gene & Cell Therapy (ASGCT) has partnered with FACT and the American Society for Transplantation and Cellular Therapy (ASTCT) to bring you the two-part webinar series, “Centers’ Experience with Implementing Commercial CAR T-cell Products.”
The first webinar will be on Thursday, July 25, 2019 at 11:00 am ET. Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in this process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.
Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regards to the following:
- Agreements with Manufacturers
- Reimbursement
- FACT accreditation
View meeting details and register
FACT Education Events
Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar
This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, have graciously agreed to share their tool designed in Microsoft OneNote to be used for continuous readiness and compliance with FACT requirements.
Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.
View meeting details and register online
ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products –
Part 1
Thursday, July 25, 11:00 am ET
Webinar
The first webinar in this two-part webinar series will be on Thursday, July 25, 2019 at 11:00 am ET. Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in the process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.
This is part one of two in the Centers’ Experience with Implementing Commercial CAR T-cell Products series. Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regards to the following:
- Agreements with Manufacturers
- Reimbursement
- FACT accreditation
View meeting details and register
FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil
This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
- Provide an overview of the FACT Standards and accreditation process
- Explain how to integrate quality management into clinical, collection, and cell processing programs
- Examine how to prepare for a successful inspection
- Summarize how controlling documentation can improve your program
- Review commonly cited Standards
- Outline the inspector orientation process
- Answer questions
This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.
View meeting details and register
WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL
The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.
Topics will include:
- Global perspectives of the regulation of cord blood banking
- WMDA serious adverse events and reactions
- Analysis of CD34+ and CD45+ cells in thawed cord blood samples
- Analysis of cellular viability in thawed cord blood
- Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards
- Essential Quality Management Principles
The afternoon offers two tracks:
- WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
- FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.
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 Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!
FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI
This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.
View meeting details and register
Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar
This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.
View meeting details and register