Just the FACTs, Volume 11
To those of you in the Northern Hemisphere, the days are getting shorter meaning you obviously should be sleeping better—oh, I forgot, we’re transplanters so that’s not allowed. Well, drive carefully in the dark, while all our colleagues down south, enjoy the longer days for more golf—oh, I forgot, we’re transplanters so we probably don’t play golf.
Down to the real stuff, the CIBMTR committee on Infection and Immune reconstitution is doing important work to help us all learn more about post-transplant infections, one of the big opportunities for improvement of patient outcomes. The FDA Cell Therapy Liaison Meeting (CTLM) in March addressed a number of topics, one of which is the collection of MNCs that are then sent to outside companies for manufacturing. The variation of collections (which are really a part of the manufacturing flow, but that is another bone to pick) was raised, both technical issues and the patient issues affecting the cell quantities and therefore product effects was accepted as an important question by the FDA.
Lastly, I invite you to one or more of the FACT activities at the upcoming TCT meetings: The Inspection and Accreditation Workshop and Leadership courses are on Tuesday, February 18th, prior to the opening of the TCT conference, and the Quality Boot Camp is on the 19th, the TCT pre-conference day. On the 20th there will be a gathering for International Delegates hosted by the FACT Global Affairs Committee. We look forward to seeing you at one or more of these in 2020!
Enough for now, I have to go change the battery in my headlamp . . .
Sincerely,
Dennis Gastineau, MD
FACT President
CIBMTR Infection and Immune Reconstitution Working Committee Outlines Challenges and Progress
FACT and the Center for International Blood and Marrow Transplant Research (CIBMTR) collaborate in a variety of ways to use the power of data to improve patient care within individual transplant programs and the field as a whole. The FACT-CIBMTR Data Audit Committee evaluates corrective action plans (CAPs) for data management in the context of CIBMTR data audit results. The FACT Clinical Outcomes Improvement Committee evaluates CAPs for clinical outcomes, including when risk-adjusted one-year survival does not meet the expected range of the CIBMTR Transplant Center-Specific Survival Report.
Infection data are an important part of both of these efforts. Cause of death is a critical field within CIBMTR’s on-site data audits. Infection is one of the most commonly reported causes of death reported to FACT in clinical outcome CAPs.1 This data is a complex field to report but could hold the key to many ideas to improve patient survival following transplantation.
Fortunately, there is a committee for that. According to the website, cibmtr.org, “The CIBMTR Infection and Immune Reconstitution Working Committee provides scientific oversight for studies about prevention and treatment of post-transplant infections and issues related to recovery of immune function.”
This working committee recently published an update of its challenges and progress in the CIBMTR newsletter. This update provides statistics about infection-related deaths and issues that make the collection of infection data complicated and demanding. The CIBMTR committee also extended its appreciation to data managers for providing the committee with the high-quality data it needs to do its important work. (Please send their thanks to your data management team!) Finally, the committee closed its article with a list of manuscripts that may help your program improve patient survival. We encourage you to take advantage of the knowledge gleaned from the work of this expert committee of physicians and statisticians, made possible by the data you all submit.
1LeMaistre, C.F., Wacker, K.K., Akard, L.P., Al-Homsi, A.S., Gastineau, D.A., Godder, K., Lill, M., Warkentin, P.I. (2019). Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model. Biology of Blood and Marrow Transplantation, 25, 2243-2250. https://doi.org/10.1016/j.bbmt.2019.06.035
Variability in Cell Collection for IEC Products Discussed with FDA during 2019 Cell Therapy Liaison Meeting
The Food and Drug Administration Cell Therapy Liaison Meeting (FDA CTLM) took place on March 5, 2019 and a summary of the meeting is now online. This meeting was made possible by 13 organizations serving the planning committee, led by Olive Sturtevant and the ISCT North America Legal and Regulatory Affairs Committee. Ms. Sturtevant is also a member of the FACT-JACIE Standards Steering Committee.
Four topics were presented to the FDA, including regulation of biobanking material for future products, collection of mononuclear cells (MNCs) for immune effector cell (IEC) products, minimum characterization criteria for clinical grade induced pluripotent stem cell (iPSC) products, and early interaction mechanisms for tool/device developers.
The presentation and discussion regarding the collection of MNCs for IEC products is particularly timely for many FACT-accredited apheresis facilities. The summary outlines the challenges Dr. Jay Raval presented on behalf of the American Society of Apheresis (ASFA) and the discussion with the FDA afterwards.
This summary may be useful to discussions between apheresis facilities and the commercial manufacturers they work with. It also provides ideas that the field could pursue to reduce variability to a meaningful level that will ensure quality IEC products without limiting the ability of experienced apheresis facilities to care for their patients.
This meeting is just one event regarding this issue in which FACT participated. We will continue to provide updates via the Just the FACTs newsletter as appropriate. In the meantime, we have appreciated the spirit of collaboration that has been demonstrated by commercial manufacturers, healthcare providers, related organizations, and many others.
Online List of Accredited Organizations Can Now be Downloaded
The official list of FACT-accredited organizations is the online version available via the FACT website. This online list includes many features that allow users to search for programs with specific criteria.
We are happy to announce that the website now allows users to download the entire list of accredited organizations. A download button is available at the top of the screen, and will download the list in Excel format. All of the details available online are also included in the Excel file. The download data updates every hour.
It is important to emphasize that the online listing is the official version. If there is ever a discrepancy, the online listing prevails.
NEW in 2020! ASTCT Institutional Bulk Membership for Affiliate Members
ASTCT announced last month that it would be offering a new type of membership: Institutional Affiliate Membership. The new system allows institutions or organizations to purchase memberships as a group, offering a single invoice for multiple affiliate members. This type of membership offers the same benefits as an individual one: Access to the communities, ability to join a SIG or committee, and a subscription to BBMT, to name a few.
Institutional Bulk Membership can be purchased for Affiliate Members in groups of 5 or more individuals. Pricing is set at $140 per person. The Institutional Bulk Membership will go into effect on January 1, 2020. Current members may sign up to convert their membership to an Institutional Bulk Membership. Non-members should complete the form linked below, and ASTCT staff will contact you to finalize your membership.
ASTCT Institutional Bulk Membership details
ASTCT Institutional Membership Form
FACT Education Events
We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!
FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the FACT-JACIE Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.
The workshop includes two tracks: Applicant training and inspector training. 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. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.
Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!
Register for the FACT workshop
FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm
Everyone wins when a leader gets better. If you want to improve your leadership skills, this half-day course is for you. This course is open to anyone who has (or aspires to) a leadership position – 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.
Register for the FACT Leadership 101 course
FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm
A healthy organization can be your competitive advantage.
If you completed the Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you. This advanced course drills deeper into leadership skills and organizational health.
Register for the FACT Advanced Leadership 201 course
FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm
Join us for a day focused on core quality concepts. The sessions will include quality processes programs have implemented and incorporating Immune Effector Cells into all parts of your quality program. A self-assessment will be distributed prior to the TCT Meeting to review key features of your quality program and identify ongoing challenges. Complete the self-assessment, join the roundtable discussions, participate in the activities, and leverage QA experts for ideas on how to take your program’s quality program to the next level.
Register for the FACT-ASTCT Quality Boot Camp
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, 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 in Latin America, the new joint FACT-SBTMO Accreditation Program in Brazil, and efforts to provide guidance to transplant centers in India. This 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 for the FACT Global Affairs session
FACT Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the NetCord-FACT Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.
The workshop includes two tracks: Applicant training and inspector training. 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. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.
Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!
Register for the FACT workshop
