Mikaela VanMoorleghem, Education and Training Coordinator, Foundation for the Accreditation of Cellular Therapy
FACT EVENTS AT THE 2019 TCT MEETINGS WERE A SUCCESS!
FACT hosted several popular events at the 2019 TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR in Houston, Texas. Over 150 people joined FACT on February 19 for the Cellular Therapy Inspection and Accreditation Workshop, which included major topics such as building quality into clinical immune effector cell programs, risk evaluation and mitigation strategies, using the Tracer Methodology to assess compliance with standards, common citations, reviewing clinical outcomes, and improving data management through follow-up. Also on February 19, FACT hosted two cellular therapy leadership courses for anyone who has, or aspires to, a leadership position in cell therapy.
On February 20, FACT teamed up with ASBMT to host the 4th annual Quality Boot Camp. Over 130 people participated in the boot camp. This year’s agenda focused on topics such as dashboards and scorecards, record retention, risk assessment, integrating IECs into your HCT program, and evaluating the quality of your program through auditing. Quality experts presented core concepts, led roundtables, and answered questions to help others reach their quality management goals.
Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 21. Members of the FACT Global Affairs Committee provided attendees 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.
On February 21, in the session titled, Quality in HCT: Center-Specific Outcomes, Dr. Dennis Gastineau, FACT President and member of the FACT Clinical Outcomes Improvement Committee, shared guidelines for corrective action plans, and trends noted in the plans reviewed, including causes of death, challenges in root cause analysis, and ideas for improving one-year survival.
On February 22, FACT hosted a social hour for all FACT inspectors and inspector trainees in honor of their dedication and service provided to the cell therapy community. FACT relies on volunteer inspectors and appreciates their superior service, time, and expertise.
In addition to these events, FACT welcomed visitors to its exhibit booth and conducted several meetings with its active committees.
All events were successful and FACT looks forward to the 2020 Transplantation and Cellular Therapy Meetings in Orlando, Florida!
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DRAFT SEVENTH EDITION CORD BLOOD STANDARDS PUBLIC COMMENT PERIOD EXTENDED
The draft Seventh Edition NetCord-FACT Cord Blood Standards and accompanying Accreditation Manual were published for public review and comment for a 90-day period on November 30, 2018. To ensure that members of the cord blood community have reviewed the proposed significant changes in the draft Standards, and have had an opportunity to provide their input, the comment period is extended for an additional 30 days. Comments will now be accepted through April 1, 2019. Links are provided below to the draft Standards, Accreditation Manual, and comment form.
These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.
Comments on any aspect of the draft are welcome. However, members of the cord blood community are strongly encouraged to specifically review and provide comment on three significant changes proposed in the draft Seventh Edition:
1. ISBT 128 and Eurocode Coding and Labeling (B6.1.2, Appendix II)
2. Supplies and Reagents of the Appropriate Grade (B8.4.1)
3. Viability of CD45 Testing and Specification Requirements (Appendix IV, Appendix V)
Description and Instructions for Review and CommentComments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form.
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual
Comments will be accepted through April 1, 2019.
For questions or assistance, please contact Andra Moehring.
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CALL FOR FACT VOLUNTEERS
FACT has several committees to achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
FACT invites inspectors to review the charges for its committees with current vacancies and either nominate yourself or a colleague to serve as a committee member.
Education Committee
Purpose: To develop education and training programs for inspectors and for personnel at applicant and accredited facilities to promote knowledge and understanding of current standards, create awareness of commonly cited deficiencies, and promote quality in cellular therapy.
Responsibilities:
- Attend monthly one-hour teleconference
- Develop content for workshop and webinar presentations
- Assess effectiveness of training events and recommend improvements
- Serve as a FACT workshop presenter at various meetings
- Develop content for inspector continuing education
Quality Management Committee
Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.
Responsibilities:
- Attend monthly one-hour teleconference
- Maintain and update the FACT Quality Management Handbook
- Offer a comprehensive schedule of webinars related to quality management activities
- Develop content for quality “boot camps”
- Develop quality metrics for gauging the performance of the FACT inspection and accreditation process, including effectiveness, efficiency, and customer satisfaction
FACT-CIBMTR Data Audit Committee
Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.
Responsibilities:
- Attend monthly one-hour teleconference
- Develop mechanisms by which CIBMTR and FACT can coordinate audits and inspections of data management processes within transplant centers
- Develop a collaborative approach to evaluate the results of FACT inspections with CIBMTR’s data audit findings to ensure a coordinated response to the transplant center
- Participate in the joint FACT-CIBMTR data review process by assessing programs’ progress on implementing corrective action plans
- Develop education and provide assistance to programs throughout the accreditation cycle to achieve quality improvement in data management
Technology Committee
Purpose: Enhance, refine, streamline, and improve the efficiency of the accreditation process and educational programs through the continued improvement of technology and FACT’s online presence.
Responsibilities:
- Attend quarterly one-hour teleconference
- Suggest ideas to enhance user’s experience using the Accreditation Portal
- Evaluate and review new portal features
- Evaluate new technologies to improve business processes
- Interface with other committees to identify data needs to develop and publish reports
- Evaluate a mobile app option for FACT’s resources such as Standards, announcements, newsletter, and education
Please submit your interest in serving as a committee member along with a description of your qualifications to Linda Miller at lmiller1@unmc.edu by March 1, 2019.
The contributions of our volunteer FACT inspectors and committee members have been invaluable and have resulted in the tremendous success of FACT. Thank you to our volunteers for their dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continued development in the field of cellular therapy.
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NEW FACT WORKSHOP EDUCATIONAL OPPORTUNITIES
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 and 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 with 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:
- Overview of FACT Accreditation Processes
- Common Citations Overview
- Building Quality into Clinical Immune Effector Cell Therapy Programs
- Using the Tracer Methodology to Assess Compliance with FACT Standards
- How to Prepare for and Conduct Inspections
- Improving Data Management Through Follow-Up
- FACT Process for Reviewing Clinical Outcomes
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
QUALITY MANAGEMENT SERIES, MODULE 9: AUDITING
The Quality Management Series Module 9 includes four sessions focused on auditing. The first session, Auditing: Planning and Executing, was held on January 23, 2019. Leigh Poston, BMT Program Quality Management Coordinator at UF Health Shands Hospital, discussed designing audit strategies, identifying specific audits to perform, creating an audit schedule, determining the scope of the audit, and executing the audit.
View on-demand webinar
The second session, Auditing: Summarizing and Evaluating the Data, will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, 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.
Auditing: Summarizing and Evaluating the Data
Register for the entire module to receive a 15% discount!
QM Series Module 9: Auditing
Upcoming sessions in the series include:
- Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors
- A Program's Perspective: Auditing