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 Inspectors Invited to Attend Mingle and Mimosas Networking Event at TCT

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

Thursday, February 20, 2020
7:00 am – 8:30 am

FACT invites its inspectors to mingle with colleagues while enjoying a continental breakfast and morning mimosa! We want to take this opportunity to thank all our volunteers for their continued dedication and time devoted to FACT.  We hope you can join us for a morning toast to you!

Please RSVP to Jay Ann Witt

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


FACT Announces Cord Blood Inspection and Accreditation Workshop at the 2020 ISCT Annual Meeting, Paris

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

FACT Cord Blood Inspection and Accreditation Workshop
Tuesday, May 26
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. Inspector trainees have required assignments to complete before attending the workshop. In order to attend this track, you must be pre-approved as an inspector trainee.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge! Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector and enjoy the following value-added benefits:

Exposure to Exemplary Practices

As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.

Professional Development

Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.

Influence

Inspectors have influence over FACT policies and requirements. Input from FACT inspectors is sought in the process of developing new editions of Standards.

Free Access to FACT Educational Resources

As a volunteer, you will have free access to both in-person and online educational events with an annual value over$1,800.

Information about qualifications and how to apply to become a FACT inspector can be found on the FACT website. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.

Are you ready?


Congratulations to Our New Inspectors!

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

The following individuals completed their first active inspection between November 2018 through October 2019. Congratulations and thank you for volunteering your time and expertise to advance cellular therapy! Organizations with personnel who also serve as FACT inspectors typically perform better during on-site inspections than their counterparts without an inspector. If you are interested in serving as an inspector, submit an online application! For a complete list of active FACT inspectors, view the online list of FACT Inspectors.

Rona Weinberg, PhD
Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
New York Blood Center Clinical Apheresis and Cellular Therapy Laboratory, New York

Sandy Ward, MS, BSMT
Processing: minimal manipulation of HPC
Sarah Cannon Blood and Marrow Transplant Program

Suzanne Thibodeaux, MD, PhD
Apheresis Collection
Stem Cell Transplant Program at Barnes-Jewish Hospital and St. Louis Children’s Hospital at Washington University School of Medicine

Dunia Jawdat, PhD
Cord Blood Banking, Cord Blood Collection, Cord Blood Processing
King Abdullah International Medical Research Center Cord Blood Bank

Basem William, MD, MRCP, FACP
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, Marrow Collection
The Ohio State University Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

Michael Sun, MS, SCYM(ASCP)
Processing: minimal manipulation of HPC
Thomas Jefferson University Hospitals – The Sidney Kimmel Cancer Center Blood & Marrow Transplant Program

Mary Ann Kelley, MT(ASCP)BBCM
Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
Dana-Farber Cancer Institute / Cell Manipulation Core Facility

Marco Garcia, MLS(ASCP), MS
Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
University Hospitals Seidman Cancer Stem Cell Transplant Program

Scott Koepsell, MD, PhD
Apheresis Collection, Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
University of Nebraska Medical Center/Nebraska Medicine Hematopoietic Cell Transplantation Program

Daniel Gibson, BSc (Hons) LIBMS
Cord Blood Collection, Cord Blood Processing
The Anthony Nolan Cord Blood Bank

Benjamin Tomlinson, MD
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy
University Hospitals Seidman Cancer Stem Cell Transplant Program

Sarita Joshi, MBBS, MD
Clinical Hematopoietic Cellular Therapy, Apheresis Collection
Seattle Cancer Care Alliance


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


Become a FACT Cord Blood Inspector

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

Members of FACT-accredited cord blood banks are aware that FACT’s mission is to promote quality clinical and laboratory practice of cellular therapy and regenerative medicine. Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector to enjoy the following value-added benefits:

Exposure to Exemplary Practices

As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.

Professional Development

Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.

Influence

Inspectors have influence over FACT policies and requirements.  Input from FACT inspectors are sought in the process of developing new editions of Standards.

Free Access to FACT Educational Resources

As a volunteer, you will have free access to both in-person and online educational events with an annual value of $1,840.

Information about qualifications and how to apply to become a FACT inspector can be found at www.factwebsite.org/becomeinspector. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.

Are you ready?


FACT Education Events

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

WMDA-NetCord & FACT Cord Blood Day
September 12, 2019
Miami Florida

The World Marrow Donor Association (WMDA) and Foundation for the Accreditation of Cellular Therapy (FACT) are teaming up to host the second annual pre-conference WMDA-Netcord & FACT Cord Blood Day. The workshop incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training.

We encourage banks to send multiple personnel to attend the various tracks and enlist a member to become a FACT inspector.  Registration fees are waived for FACT inspectors and trainees. Apply to become a FACT inspector!

Join leading cord blood experts from around the world for a day of education and hands-on breakout sessions.  We look forward to seeing you in Miami!

View meeting details and register
View meeting agenda

 

 

 

 

 

 

 

 

 

 

 

 

FACT Events at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

FACT is hosting two events on pre-conference day at the ISCT North American 2019 Regional Meeting. On September 12, colleagues have the opportunity to attend the FACT Cellular Therapy Inspection and Accreditation Workshop, or the ISCT – FACT Quality Boot Camp.

We encourage programs to send multiple personnel to attend the various FACT events on September 12.  The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists.  The ISCT-FACT Quality Boot camp, which takes place on the same day as the workshop, is essential for program quality managers.

View workshop meeting details and register
View workshop agenda

View boot camp details and register now
View boot camp agenda

 

 

 

 

 

 

 

 

 

 

 

 

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar

The second webinar in this two-part webinar series will be on Thursday, September 25, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register


Inspector Insight Story: Dr. Abba Zubair Shares his Love of Learning and Friendships to Motivate Inspectors

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

Dr. Abba Zubair is the Medical Director at Blood and Marrow Transplantation Program of Mayo Clinic and Nemours Children’s Clinic and Wolfson Children’s Hospital located in Jacksonville, Florida. Dr. Zubair has 17 years of education and training including a Medical Degree from Ahmadu Bello University in Zaira, Nigeria. He completed his internship at Murtala Mohammed General Hospital located in Kano, Nigeria where Abba grew up. He was awarded Best Intern for Kano State. Dr. Zubair also earned a PhD. in Tumor Immunology from the University of Sheffield; Post-Doctorial Fellowship and Pathology and Laboratory Residency at the University Of Pennsylvania School Of Medicine; and a Clinical Fellowship in Transfusion Medicine and Masters of Clinical Science at Harvard Medical School. In 2011, Dr. Zubair completed the Quality Academy at the Mayo Clinic. Dr. Zubair has also published over 40 peer-reviewed articles.

Dr. Zubair has been a FACT inspector for 14 years, and has performed 12 Cellular Therapy and 14 Cord Blood Inspections. Dr. Arthur Jones, his chairperson at the time, encouraged him to apply after a successful FACT inspection at their program. Dr. Zubair volunteered as a FACT inspector to keep up-to-date with the FACT Standards. This has certainly proven effective. Dr. Zubair remarks, “Every time I go through the inspection process, it is like going through an entire practice of cell therapy. I get to rehearse and revise each aspect of the program’s activities, both old and new. It helps me remain current because it forces me to read and be up-to-date with current literature in the field.”

“In addition to having greater opportunity to shape the practice of cellular therapy, I benefit by developing friendships with people in my own discipline. There are two kinds of people that I am privileged to meet and establish relationships with including my team members, who join me during the inspection process, and the inspected program’s leadership and supporting staff. We share both professional and personal stories, and truly bond together. I learn about many different cultures around the world which expands my network and connections with people in the field,” states Dr. Zubair.

His experience as an inspector has contributed to improvements at his program in Jacksonville, Florida. “I observe many ways to meet the same FACT Standard and some programs meet the Standards in a better way than my own program. Every experience makes me a better leader and practitioner,” remarks Dr. Zubair.

Dr. Zubair is the current chairperson of the FACT Inspector Advisory Committee, a member of the FACT Board of Directors, and member of the FACT Cellular Therapy Accreditation Committee. His leadership qualities have made a great impact on FACT. Dr. Zubair sees many benefits of serving on FACT Committees and the Board of Directors. In his view, “Being a member of the FACT Board of Directors contributes to my leadership development which in turn strengthens my career. By being an active participant in FACT activities, I have a greater opportunity to shape the practice of cellular therapy. My contributions help generate new FACT Standards that improve the practice and application of cell therapy in medical practice.”

Dr. Zubair states that he believes knowledge is the best gift you can give someone, and the giver and the receiver both feel gratified. “Participating in FACT workshops and webinars provides a gratifying feeling that one is contributing to his own professional community.”

Dr. Zubair encourages others to volunteer as a FACT inspector because he truly believes it improves your program practice of cellular therapy and ultimately benefits the patient. Dr. Zubair’s advice to new inspectors includes:

  • Prepare ahead and manage your time during the process.
  • Have an open and positive approach to the inspection process.
  • Stay focused on the Standards – not your own institutional practice.
  • Enjoy the process!

Dr. Zubair was asked about his distinguished accomplishments and he commented, “I am the most proud of being a father of four children. Two have graduated from college, one is working as a software developer, and the other is in Medical School. My two younger children are in elementary school.”

There are many different FACT inspector categories and we encourage anyone interested in training as a FACT Inspector to apply today.

Previous Inspector Insights:

Paul Eldridge, PhD
Michele Sugrue, MS, MT(ASCP)SBB
Patrick Hanley, PhD
Richard Meagher, PhD
Jean Sanders, MD
Leonor Fernando, MD
Frank Smith, MD
Dennis Gastineau, MD


Education Events

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

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 Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!

View meeting agenda

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This workshop in Madison incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy. Several hot topics include quality management in novel cell therapies, environmental monitoring, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:

• Blood and marrow transplant (BMT) programs
• Cell processing laboratories
• Physicians, scientists, and principal investigators
• Unit supervisors, laboratory managers, administrators, nurses, and medical technologists

The day includes an applicant track and inspector training track. Inspector trainees are required to attend the inspector orientation track.

We encourage programs to send multiple personnel to attend the various FACT events on September 12.  The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists.  The ISCT-FACT Quality Boot Camp, which takes place on the same day as the workshop, is essential for program quality managers.

View meeting details and register
View meeting agenda

ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting
September 12, 2019
Madison, WI

Is your lab FACT accredited or looking to comply with FACT standards? Strengthen your quality management programs through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT compliant programs, these sessions will include activities and discussion regarding Document Control, Risk Assessment in the Processing Laboratory, Supply Qualification, and Audit Plans and Writing the Report. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution. This boot camp is applicable not only to academic labs but also relevant for commercial operations.

We encourage programs to send multiple personnel to attend the various FACT events on September 12. The ISCT-FACT Quality Boot Camp is essential for all quality and laboratory personnel. The FACT Cellular Therapy Inspection and Accreditation Workshop, taking place on the same day, is a must-see for Cell processing laboratory personnel, physicians, scientists and principal investigators, administrators and nurses.

View details and register now
View preliminary agenda

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar

The second webinar in this two-part webinar series will be on Thursday, September 25, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

• Agreements with Manufacturers
• Reimbursement

View meeting details and register 

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register 


Education Events

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar

This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, have graciously agreed to share their tool designed in Microsoft OneNote to be used for continuous readiness and compliance with FACT requirements.

Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.

View meeting details and register online

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 1
Thursday, July 25, 11:00 am ET
Webinar

The first webinar in this two-part webinar series will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in the process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

This is part one of two in the Centers’ Experience with Implementing Commercial CAR T-cell Products series.  Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

View meeting details and register

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

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 Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register 


Growing Demand for FACT Inspectors

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

As FACT accreditation expands both globally and in scope with the addition of immune effector cell therapy, a need exists for additional experienced, knowledgeable cell therapy professionals to serve as FACT inspectors.

Eligible personnel at accredited organizations are encouraged to consider the value-added benefits when you serve as a volunteer FACT inspector.

Exposure to Exemplary Practices

As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas from the facilities you inspect and your interaction with experts on your inspection team.  There’s also evidence that organizations that don’t have an inspector have more difficulty complying with current standards.

Free Access to FACT Educational Resources

Volunteer inspectors have free access to both in-person and online educational events with an annual value of $1,840.

Contributions to Standards Development

Inspectors have greater opportunity to contribute to the development of FACT Standards. The opinions of FACT inspectors are always sought early in the process of developing new editions of standards and accreditation requirements. Eligibility of key FACT committees also requires that members be, or have been, a FACT inspector.

Professional Development

Your organization will appreciate your skills and experience when you serve as a volunteer FACT inspector. “FACT Inspector” also looks great on a curriculum vitae!

The American Society for Transplantation and Cellular Therapy’s (ASTCT) new elite Leadership Course designed to provide training and develop the next generation of leaders in the field of blood and marrow transplantation and cellular therapy encourages selected participants to serve as a FACT inspector.

Join our Team – Apply to be a FACT Inspector

Information about qualifications and how to apply to become a FACT inspector can be found at www.factwebsite.org/becomeinspector. If you have any questions, don’t hesitate to contact the FACT office.

 


The Countdown is on to Register for FACT Events at the ISCT Annual Meeting!

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

Register Now and Save!

FACT Accreditation Workshop
Join your fellow cellular therapy and cord blood colleagues for several FACT events at the 2019 ISCT Annual Meeting in Melbourne, Australia.  On May 28th FACT will host a Cellular Therapy and Cord Blood Inspection and Accreditation Workshop from 8:00 am to 5:00 pm.  This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management.  Register before May 28th and save $100!

Fees are waived for active and trainee inspectors.  Apply to volunteer and train as a FACT inspector.

ISCT-FACT Quality Boot Camp
On May 29th ISCT and FACT will host a cellular therapy Quality Boot Camp for sessions that include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

FACT Exhibit Booth
FACT representatives will be at exhibit booth #36 to provide information about FACT Standards and Accreditation. We would love to see new and familiar faces!

Exhibit Booth Dates and Times:

Wednesday, May 29th: 19:30 – 21:30
Thursday, May 30th: 09:00 – 19:30
Friday, May 31st: 09:00 – 18:30

Take advantage of these exciting FACT events by registering now! We look forward to seeing you in Melbourne!

 


WMDA-NetCord & FACT Cord Blood Day – September 12, 2019 at the Cord Blood Connect International Congress

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

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 Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!


Education Events

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
Melbourne, Australia

This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event 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

The day includes a general track for attendees with separate breakout sessions for cellular therapy and cord blood participants. Inspector trainees are required to attend the inspector orientation track.

View meeting details and register
View preliminary agenda

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.

Sessions include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

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
• Improving Data Management Through Follow-Up
• FACT Process for Reviewing Clinical Outcomes

View meeting details and register online

Quality Management Series 9 Webinar: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors – June 11, 2019

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, was live on March 6, 2019. Ed Brindle MSc, MLT, Quality Manager at UHN Blood and Marrow Transplant Program, discussed writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. View on-demand webinar

The third webinar in the QM series 9: Audits, titled Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors, will be on June 11, 2019 at 11:00 am ET. Gordana Svajger, Quality Compliance Program Manager at The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program, will identify methods for verification of corrective actions, interpret when corrective actions are effective, and determine when to close an audit.  View webinar details and register

The last session in the series will be, A Program’s Perspective: Auditing. The date and time will be announced when determined.

Register for the entire module to receive a 15% discount! QM Series Module 9: Auditing

Exceeding Expectations: How We Maintain High One-Year Survival
Wednesday, June 12, 3:00 pm ET
Webinar

The FACT Education Committee, in conjunction with the Clinical Outcomes Improvement Committee, is presenting a webinar on June 12, 2019, at 3:00 pm ET, to highlight transplant programs that consistently exceed expected one-year survival rates as reported in the CIBMTR Transplant-Center Specific Survival Report. This webinar will consist of presentations from the Blood and Marrow Transplant Program at Northside Hospital, Vanderbilt University Medical Center, and the FACT inspectors who evaluated them during the most recent inspections. This will be a one-hour webinar, which includes a question and answer session.

Program representatives will discuss the following:
1) how the program analyzes and trends clinical outcomes including survival,
2) aspects of the program believed to contribute to consistently high one-year survival (e.g., processes, guidelines, education, and any other aspect), and
3) any examples of instances in which the program made adjustments after detecting declining survival rates for a given set of patients.

The inspector from each program will discuss his impression of the program and opinions on why the program consistently achieves high survival rates.

View meeting details and register online

Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar

This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, will provide instruction on design and use of Microsoft OneNote that may be used for continuous readiness and presentation during on site FACT inspections.

Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts, etc.). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.

View meeting details and register online

WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

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 Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.

View meeting details and register


Thank you FACT Inspectors

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

As a non-profit organization, the Foundation for the Accreditation of Cellular Therapy (FACT) relies on dedicated volunteers to achieve its vision of being the premiere organization in setting standards and awarding accreditation to programs in the evolving field of cellular therapy. We consider our inspectors “the heart and soul” of FACT and are committed to showing our appreciation for their continued service.

Inspector Recognition Packets

Our volunteer inspectors play an instrumental role in FACT’s success by devoting their time and expertise to complete more than one hundred FACT inspections each year.

In December 2018 we distributed inspector recognition packets containing a thank you letter, a certificate acknowledging the year in which the inspector started performing FACT inspections, and the total number of inspections performed to date, as well as a FACT Inspector lapel pin.

Inspector Photo Banners

FACT Inspectors take care to professionally represent FACT when performing inspections. We are proud of the service they provide to FACT and our accredited organizations. To showcase this amazing group of individuals, we compiled portrait photos of inspectors into display banners for cord blood and cellular therapy inspectors. The banners were exhibited at the FACT workhops during the 2018 Cord Blood Connect international congress September 14-16, 2018, in Miami Beach, Florida, and the 2019 TCT Meetings, February 19-23, 2019 in Houston, Texas. Not only are the banner displays an excellent opportunity for us to recognize our inspectors, but it has been said that a picture is worth a thousand words, and  we could not agree more! Be sure to watch for the banners at future FACT workshops.

Inspector Social Hour

FACT hosted its first Inspector Social Hour during the TCT Meetings in Houston on February 22, 2019. Attendees enjoyed hors d’oeuvres and cocktails while networking and socializing with peers after a long week of meetings.

FACT Inspector Directory

A list of active FACT inspectors is published on the FACT Website. The FACT Inspector Directory is updated quarterly and lists inspectors in order of country of residence and last name.

Interested in becoming a FACT inspector? Visit the FACT Inspector Application page on the FACT website for more information.

Thank you!

The achievements of FACT are attributed to the generosity of our volunteers in lending their time and expertise to the accreditation process.

A sincere thank you to all our volunteers. Your excellence drives our success!


Call for FACT Volunteers

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

Dear FACT Colleague:

The Foundation for the Accreditation of Cellular Therapy has several committees to help FACT achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.

In light of your experience and important involvement with the FACT inspection and accreditation process, we invite you to review the charges for the 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 for your dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.

Sincerely,

Dennis Gastineau, MD

President

Linda Miller, MPA

Chief Executive Officer


FACT Inspectors are Invited to Social Hour during TCT Meetings

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

In honor of their dedication and service provided to the cell therapy community, FACT Inspectors are cordially invited to attend the FACT Inspector Social Hour on Friday, February 22, 2019 at the Hilton Americas-Houston Hotel, Room 335B from 5 pm – 6 pm. Light hors d’oeuvres and cocktails will be provided.