To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.
FACT Inspection and Accreditation Workshop
February 4, 2021
This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop. Information will interest initial applicants and those who have attended previously.
Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.
Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.
FACT-ASTCT Quality Boot Camp
February 5, 2021
Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.
Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example. “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:
- Perform a Facility Needs Assessment
- Develop a Change Control
- Execute Risk Assessments
- Determine what to Validate and Audit
- Perform Validation(s)
- Establish Quality Indicators
- Perform Audits
At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.
FACT hosted several popular events at the 2020 TCT | Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR in Orlando, Florida. On February 18, the FACT Cellular Therapy Inspection and Accreditation Workshop brought together 155 attendees. The workshop included two tracks: Applicant training and inspector training. The applicant track described the accreditation process from application to accreditation. Applicants were given a short overview on how to navigate the accreditation application in the Accreditation Portal, and evaluated documentation to ensure compliance. In addition, applicants learned how to organize the on-site inspection process, structure a program tour, evaluate deficiencies, and maintain accreditation readiness.
The inspector training track was required for all inspector trainees. This track was 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 received an inspection checklist accompanied by applicable inspection documents. Trainees were instructed on the duties of the inspector prior to the inspection and how to navigate an application using the Accreditation Portal. Also, trainees developed a plan for review of documents submitted in advance of the on-site inspection, evaluated documents to determine compliance, used an inspection checklist, and prepared for all duties post-inspection.
Also on February 18, FACT hosted two Cellular Therapy Leadership Courses for over 30 people who have, or aspire to, a leadership position in cell therapy. Attendees of the Cellular Leadership 101 course learned a variety of leadership strategies including:
• The leader as coach
• Differences between managing and leading
• Basic styles of leadership and how to recognize your own style
• When each style of leadership may be appropriate
• Chairing and participating in effective meetings
• Delegation skills
• How to build consensus
• Ways to motivate, ignite, inspire, transform and engage teams
Participants who participated in the Advanced Cellular Therapy Leadership Course dug deeper into leadership skills and organizational health, and examined the following topics:
- Characteristics of a healthy organization
- Adapting an organization to a changing environment
- Leading from where you are
- Multiplying and diminishing team effectiveness
- Servant leadership
- How to be change agent
- Effective governance boards
- Legal liability and fiduciary responsibilities in decision-making
- Strategic planning with a focus on outcomes
On February 19, FACT teamed up with ASTCT to host the 5th annual Quality Boot Camp, setting record breaking attendance with over 160 participants. The day featured many interactive sessions, including how to assess the effectiveness of your Quality Management Program, practicing interview techniques when performing an audit, and identifying the difference between a verification, qualification, audit, and validation. Attendees were engaged throughout the day, asking questions and participating in productive discussions. One attendee commented, “the speakers made the presentations relative to actual practice – not just definitions on slides. Overall, the boot camp made my trip to Orlando worthwhile and offered more learning opportunities…”
On February 20, FACT hosted a Mingle and Mimosas Networking Event for Inspectors to show our appreciation and toast our essential volunteers for their continued dedication and time devoted to FACT.
Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 20. Members of the FACT Global Affairs Committee presented 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.
In addition to these events, FACT welcomed visitors to its exhibit booth and invited meeting participants to the booth to meet the leaders of Accreditation Services and have accreditation and standards questions answered.
All events were successful and FACT looks forward to the 2021 Transplantation and Cellular Therapy Meetings in Hawaii!