September 2018: FACT Update

By Content Administrator posted 08-31-2018 12:13

By Mikaela VanMoorleghem, FACT education and training coordinator

Data Management Resources Serve as Gateway to Improving Reporting

To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews each program’s most recent CIBMTR data audit results including implementation, adequacy, and effectiveness of the corrective action plan (CAP). The committee’s goal is to provide education and assistance to cellular therapy programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.

Since its inception, the committee has provided extensive guidance and assistance to programs regarding data management, audit, and quality improvement principles. Using this experience, the committee created a Data Management resources area to assist programs. Programs are encouraged to review this information, which contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.

The FACT-CIBMTR collaborative data audit process was formed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited transplant programs. The program intensifies support and improvement of data management and reporting processes, and these new resources support these efforts. In addition to the website, view previous newsletter articles about the program:

FACT and CIBMTR Announce Joint Data Audit Program

The Role of Medical Records During On-Site Clinical Program Inspections

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.

Submit Exemplary Quality Management Processes for FACT Quality Boot Camps

The FACT Quality Management Boot Camps are popular meetings during which quality management principles are discussed in detail. A hallmark of the quality boot camp format is its focus on tangible examples directly used by accredited cellular therapy programs and cord blood banks. FACT invites cellular therapy and cord blood professionals to submit examples of innovative and effective quality management processes. The FACT Quality Management Committee will review and select commendable practices for presentation at a future quality boot camp. This is a great opportunity to showcase your organization’s success with your peers.

Do you have a quality management-related process that has worked particularly well for your organization? Are you a FACT inspector that has been impressed with an organization’s process? If so, please submit a description of the process and example documents to Heather Conway at  Example processes include quality assessment activities, personnel training and competency, document control, procedural development, and other concepts related to quality management.

The next boot camp will take place during the WMDA-NetCord & FACT Cord Blood Day on September 14, 2018. Stay tuned for future boot camps in 2019!

Calling All Clinicians! Invite Your Pharmacists to Attend the FACT Webinar: The Impact of CAR-T Cell Therapy and FACT Standards on the Role of the Pharmacist – September 19

The Impact of CAR-T Cell Therapy and FACT Standards on the Role of the Pharmacist webinar is Wednesday, September 19, 2018, at 11 am ET, 3:00 pm GMT. FACT pharmacy requirements relate to those who perform services for the transplant program. Compliance with these standards cannot be achieved without clinicians and pharmacists working together. 

The Impact of CAR-T Cell Therapy and FACT Standards on the Role of the Pharmacist webinar is relevant to both clinicians and pharmacists. Join Nicole Watts, PharmD, BCOP, Clinical Pharmacy Specialist at the University of Alabama at Birmingham, as she presents the role of pharmacists in the management of immune effector cellular therapy and provides updates to the FACT pharmacy requirements. Dr. Watts will also provide education regarding toxicity identification and management, including CRS and CRES, the role of Tocilizumab, and the role of steroids.

View meeting details and register