FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Draw Record Attendance

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

The second month of 2021 brought success by way of greatly increased access to FACT’s education for an expanded online audience. FACT held its second virtual Inspection & Accreditation Workshop on February 4th and first virtual FACT-ASTCT Quality Boot Camp on February 5th. Though the pandemic prevented the conference from taking place in Hawaii during the TCT meetings, it could not stop the cellular therapy community from catching up with dearly missed colleagues over virtual coffee and continuing to advance their programs via e-learning. Over 300 individuals joined each of the live events resulting in record attendance for both the workshop and the boot camp.

We send a huge thank you to our workshop chairs, Dr. Dennis Gastineau and Dr. Jean Sanders; our boot camp chairs, Dr. Kimberly Kasow and Therese Dodd; the FACT Education and Quality Management committees; our fabulous presenters and facilitators; and, of course, our attendees for their abundance of energy and enthusiasm.

FACT Inspection & Accreditation Virtual Workshop – February 4, 2021

The workshop day was divided into morning and afternoon sessions. The morning catered to individuals new to or relatively inexperienced with FACT Standards and the accreditation process. The sessions included:

  • An overview of FACT Accreditation
  • A review of the compliance application process
  • How to prepare for an inspection
  • A virtual tour of an accredited clinical program
  • Common challenges clinical programs encounter & how to correct the deficiencies
  • How to maintain FACT Accreditation

The afternoon was prepared with more advanced content for attendees that had previously attended a workshop and were more familiar with FACT Accreditation. The sessions included:

  • How to prepare for a FACT virtual inspection
  • A sneak peek at the Eighth Edition for Cellular Therapy Standards
  • Data management
  • Outcome analysis

     

 FACT-ASTCT Quality Boot Camp – February 5, 2021

The boot camp focused on a holistic approach to the quality system by featuring core quality concepts in the presentations and interactive sessions. The boot camp showed attendees how to navigate the quality system from start to finish. The sessions included:

  • What to consider for performing a feasibility needs assessment from a new IEC program perspective
  • An overview of the change control process and its development for new or changing services
  • How to execute the risk assessment process and plan with help from a matrix table
  • Reviewing what to validate and how the validation process works
  • How to establish quality indicators
  • An overview of auditing in terms of what, when, and how
  • Interactive discussions to reinforce the concepts of change control, risk assessment, validation, and audits

       

Both the workshop and the boot camp included optional sessions at lunch. The first session was an interview with Dr. Nelson Hamerschlak and Dr. Andrea Kondo from the Hospital Israelita Albert Einstein in São Paulo, Brazil. The transplant program leaders discuss how FACT Accreditation has benefited their program and prepared them to safely manage patients during the COVID-19 pandemic. The second session was a speech from incoming FACT President, Catherine Bollard, about her vision for FACT as we move forward. (Click on the images below to watch the videos free of charge!) Jeopardy was a popular segment in both conferences as participants enjoyed reinforcing concepts discussed throughout the day in a fun and interactive method.

The end of the day closed with a third optional session led by FACT IT Business Analyst, Alisa Forsythe, during which she trained accredited users on the FACT Portal.

Click on the images to watch the videos free of charge!

We look forward to FACT’s next Processing and Apheresis Accreditation & Inspection Workshop and Quality Boot Camp on Thursday, May 6 and Friday, May 7, 2021!

 


Save the Date! FACT Announces the Apheresis and Processing Accreditation & Inspection Workshop and Quality Boot Camp on May 6-7, 2021

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021


Upcoming Events

Posted in :: 2021 Volume 1 :: Friday, January 29th, 2021

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.

Workshop Objectives:
• 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.

Register for the virtual workshop

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.

Register for the virtual boot camp


FACT Announces Upcoming Virtual Events

Posted in :: 2020 Volume 9 :: Monday, December 14th, 2020

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.

Workshop Objectives:
• 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.

Register for the virtual workshop

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.

Register for the virtual boot camp


FACT Events at the 2020 TCT Meetings Were a Success!

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

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!


FACT Education Events

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

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-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 ASTCT & 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

FACT Cord Blood Inspection & Accreditation Workshop
September 9, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. 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. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge!

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 applicant and inspector training track!


FACT Announces Events at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

FACT Cellular Therapy Inspection and Accreditation Workshop – February 18

FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.

Register for the FACT workshop
Apply to be a FACT inspector

Cellular Therapy Leadership Course 101 at TCT Meetings – February 18

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you hone your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the Leadership Course 101

Cellular Therapy Advanced Leadership Course 201 at TCT Meetings – February 18

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the Advanced Leadership Course 201

FACT-ASTCT Cellular Therapy Quality Boot Camp – February 19

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session February 20

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. 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 Events at the ISCT North American Regional Meeting a Success!

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

Cellular Therapy Inspection and Accreditation Workshop

FACT workshop presenter, Dr. Jean Sanders.

FACT was excited to be a part of the ISCT North American Regional Meeting in Madison, Wisconsin. Participants joined FACT on September 12, 2019, for the FACT Cellular Therapy Accreditation and Inspection workshop.   The workshop included individuals from the United States, Canada, and Australia.

Applicants discussed the challenges complying with FACT Standards and demonstrated how to overcome them; reviewed how to perform a risk assessment, practiced the use of the 5 Whys process, and evaluated the distribution of cellular therapy products. In addition, Dr. Jean Sanders presented about quality management in novel cell therapies.

Inspector Trainees participated in a separate training track in which they engaged in activities to effectively perform an inspection. Trainees worked with the inspection checklist and prepared comments noting noncompliance with standards, evaluated SOPs for training and competency, developed a plan for pre-inspection, and appraised unexpected issues that come up during an inspection along with proposed resolutions.

Sincere thanks to all of the participants, the invited speakers, the local organizers, and ISCT for their support.

ISCT-FACT Cellular Therapy Quality Boot Camp

Assessing Risk Assessment

Therese Dodd, Vice Chair of the FACT Quality Management Committee, welcomed the attendees and began the day with a presentation on “Assessing the Effectiveness of Your Quality Plan.”  A roundtable session followed where scenarios were used to evaluate the effectiveness of the QM Plan.  Federico Rodriguez discussed how the “Five Whys” can be used when evaluating occurrences, whether detected during an audit or when the occurrence is identified.  One of the most popular presentations was “Integrating Risk Assessment into Your Quality Program” presented by Amy Beres and Jennifer Frank. The FACT Quality Management Committee acknowledged Aurora Health Care Autologous Stem Cell Transplant Program’s risk assessment process as a commendable practice.  The attendees practiced using the risk assessment tools and over half indicated that they will incorporate this process at their program.

The afternoon began with “Supply Qualification” presented by Deborah Griffin and Emily Hopewell.  A supply qualification assessment tool was provided and used during a hands-on exercise.  A third of the attendees plan to update their supply qualification process with the information provided.  Ed Brindle provided an interesting history of Document Control as it relates to the FACT-JACIE Hematopoietic Cellular Therapy Standards and how the UHN Blood and Marrow Transplant (BMT) Program is transitioning to an electronic document control system.  The final presentation focused on planning audits and writing an audit report presented by Heather Conway, FACT-ISCT Data Audit Committee member.  During the audit activity session attendees used ISBT’s Audit Tool, and discussed how the tool can be used in conjunction with FACT labeling requirements in an internal audit.  The day ended with an opportunity to “Ask FACT” about issues, processes, and/or documents with a presenter of their choice.  Thank you to the attendees and presenters for great discussions throughout the day!

 

Boot camp attendees using the ISBT 128 Audit Tool

Boot camp attendees assessing risks related to occurrences

FACT Exhibit Booth

FACT welcomed visitors to its exhibit booth at the ISCT North American Regional Meeting.  We enjoyed visiting with new and familiar faces!

 


FACT-ASBMT Quality Boot Camp 2019

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019


The fourth annual FACT-ASBMT Quality Boot Camp, held in conjunction with the TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR, will be held on February 20, 2019.  Join the FACT Quality Management Committee and the ASBMT Administrative Directors SIG Quality group, and learn from your quality colleagues.  This year’s boot camp includes sessions on:

  • Developing a Dashboard: Program Status at a Glance
  • Performing a Risk Assessment in the Clinical Setting
  • Embracing Standardization to Create a Cohesive and Efficient System of Documentation
  • Vendor Qualification
  • Preparing for Immune Effector Cellular Therapy Accreditation
  • BMT After – Hours Call

A short self-assessment will be distributed in preparation for the boot camp to assess your needs and identify ongoing challenges.

View meeting details and register online
View the preliminary agenda