FACT-CBA Webinar: The Effect of the COVID-19 Pandemic on Cord Blood Banking

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking


WMDA-NetCord & FACT Events at the Second Annual Cord Blood Connect International Congress Were a Success

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

The WMDA and FACT hosted a pre-conference Cord Blood Day at the 2019 Cord Blood Connect International Congress in Miami, Florida on September 12. Over 50 members of the cord blood community from eleven countries attended. The day included topics such as trends in cord blood banking, emerging pathogens, harmonization of testing procedures between cord blood banks and cellular therapy laboratories, and cord blood selection services for transplant centers. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.

In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth!

 

 

 

 

 

All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 10-12, 2020, in Miami Beach!

WMDA-NetCord & FACT presenters: Robyn Rodwell, Dunia Jawdat, and Heidi Elmoazzen

FACT Chief Medical Officer Phyllis I. Warkentin and WMDA-NetCord & FACT Cord Blood Day Chair Ngaire Elwood

WMDA-NetCord & FACT presenters: Alexander Platz, Gesine Koegler, and Phillip Johnson

 


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


Join Your Cord Blood Colleagues at the Second Annual WMDA-NetCord & FACT Cord Blood Day

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

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.  Register by August 31st and save $135!

View meeting details and register
View meeting agenda


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 


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


WMDA-NetCord & FACT Events at the Inaugural Cord Blood Connect International Congress Were a Success

Posted in :: 2018 Volume 4 :: Sunday, November 11th, 2018

The WMDA and FACT hosted a Cord Blood Day at the 2018 Cord Blood Connect International Congress in Miami, Florida on September 14. Over 50 members of the cord blood community from fourteen different countries attended. The day included topics such as global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.

The WMDA and FACT were honored to have Dr. Eliane Gluckman in attendance at the WMDA-NetCord & FACT Cord Blood Day. She performed the first successful human umbilical cord blood transplant and, with colleague Hal Broxmeyer, PhD, successfully showed that unrelated cord blood could be used as a source of hematopoietic stem cells. Dr. Gluckman received the first Cord Blood Association (CBA) Lifetime Achievement Award, celebrating the 30th anniversary of that event.

In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth and hosted the first Regenerative Medicine InterCHANGE, during which several societies working to advance regenerative medicine discussed their initiatives and current challenges in the regenerative medicine field.

All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 13-15, 2019, in Miami Beach!

Drs. Eliane Gluckman and Joanne Kurtzberg at the WMDA-NetCord & FACT Cord Blood Day

Dr. Joanne Kurtzberg and the first successful cord blood transplant recipient, Matthew Farrow, honored Dr. Gluckman with the CBA Lifetime Achievement Award.


Education Events

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

FACT Cellular Therapy Inspection & Accreditation Workshop
Tuesday, February 20, 2018
Salt Lake City, UT

The blood and marrow transplant field has been a leader in voluntarily improving quality, and accredited Clinical Programs are currently adapting to several new FACT Standards and procedural changes to the accreditation process. This workshop will provide background on these changes. The morning workshop sessions include major topics such as how to effectively transition to the 7th Edition Hematopoietic Cellular Therapy Standards, CIBMTR data audits, clinical outcomes including center reported causes of low survival, and the accreditation of immune effector cellular therapy programs.

The afternoon session includes two different tracks: New Inspector Training Orientation and Common Citations. The Inspector Training track includes sessions on the FACT accreditation process, what documents to review before an inspection, the ins and outs of performing an onsite inspection, how to conduct an exit interview, and finally, how to make your case via the inspection report. The Common Citations track will review recent deficiencies and corrections related to commonly cited Standards in the areas of quality management, personnel, and donor information and consent to donate. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.

Note: Inspector trainees are required to attend the New Inspector Training Orientation Track.

View meeting details and register online

Cellular Therapy Leadership Course at BMT Tandem – 101
Tuesday, February 20, 2018
Salt Lake City, UT 

Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome.

In years past, participation in FACT’s leadership workshop has been by invitation. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team

The highly interactive and participatory curriculum teaches leadership principles 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
• Running and participating in effective meetings
• How to build consensus
• Four proven ways to motivate people
• Effective delegation skills
• How to adapt to change, and even be a change agent
• Understanding and exercising governance roles and responsibilities

Woven throughout the leadership course is an overview of FACT’s organizational structure, purpose, challenges, current programs and accomplishments.

Whatever you lead, this course is designed to help you recognize 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.

View meeting details and register online  

Cellular Therapy Advanced Leadership Course at BMT Tandem – 201
Tuesday, February 20, 2018 
Salt Lake City, UT

If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Topics include:

• Characteristics of a healthy organization
• Adapting an organization to a changing environment
• Multiplying and diminishing the effectiveness of a team
• Leading from where you are
• Servant leadership
• Effective governing boards
• Legal implications of decision-making and liability and fiduciary responsibilities
• Strategic planning with a focus on outcomes

Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.

Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.

View meeting details and register online

FACT-ASBMT Quality Boot Camp
Wednesday, February 21, 2018
Salt Lake City, UT

Join us for the FACT-ASBMT Quality Boot Camp at the 2018 BMT Tandem Meetings on February 21 in Salt Lake City, Utah.  This year’s boot camp will focus on topics identified to be challenging by transplant programs complying with FACT requirements. The boot camp will strengthen your quality assurance activities through an in-person workshop. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group encourage you in the months leading up to the BMT Tandem Meetings to review your quality program and identify strengths and weaknesses.

View meeting details and register online

Effectively Transition to the 7th Edition Hematopoietic Cellular Therapy Standards
Wednesday, March 14, 2018
Webinar

This presentation will be on Wednesday, March 14, 2018, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe changes to the 7th edition Standards and provide examples for effective implementation.

View meeting details and register online

WMDA-NetCord Webinar: Manual and Automated Methods for Thawing of Cord Blood
Wednesday, March 21, 2018
Webinar

This WMDA-NetCord webinar is March 21, 2018, at 11:00 ET. Cellular therapy departments must thaw cord blood units, and they often use very different processes from the procedures outlined by the cord blood bank providing the unit. These SOPs are sent by the cord blood bank and are not always adapted to the disposals and reagents used by the department who then thaw the units. Diane Fournier, PhD, of Héma-Québec, and Roger Horton, PhD, of The Anthony Nolan Cord Blood Bank, will discuss manual and automatic thawing methods used by different departments for thawing of these units, and what can be done to improve recovery of the cells. Also, a multi-center study for harmonization of post thaw analysis of CD34 and CD45 cells will be presented.

View meeting details and register online

Cellular Therapy Collection Workshop at ASFA Annual Meeting
Wednesday, April 25, 2018
Chicago, IL

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities. FACT representatives will be in attendance to 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.

View meeting details and register online

Cellular Therapy Inspection & Accreditation Workshop
Tuesday, May 1, 2018
Montreal, Quebec Canada

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.

The afternoon session will include two different tracks (TBA). All sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.

View meeting details and register online

Cord Blood Inspection and Accreditation Workshop
Friday, September 14, 2018
Miami, FL

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will be in attendance to 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.

Would you like to attend the workshop for FREE? Apply to be a FACT inspector. If you are approved, you can attend free of charge!

View meeting details and register online

 

 


Many New Developments in FACT Standards Development Activities

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

The FACT Standards Committees have been busy reviewing feedback, discussing new developments in cellular therapy, and editing drafts for several different sets of Standards. Updates for each set of Standards are provided below. As progress continues, important updates will be announced via weekly emails and future Just the FACTs newsletters.

FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, 7th Edition

FACT and JACIE are finalizing the 7th edition Hematopoietic Cellular Therapy Standards, which is scheduled for publication in March 2018.  These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood, and administered by a blood and marrow transplant (BMT) team.

After March 1, 2018, only Compliance Applications under the 7th edition will be accepted and only inspections under this new edition will be conducted after the effective date of May 30, 2018. Programs currently pursuing renewal or initial accreditation under the 6th edition must remain mindful of these dates and ensure timely submission of pre-inspection materials and completion of the inspection.

The FACT Accreditation Services department is contacting accredited and applicant programs who will be beginning the accreditation process at the time of publication to discuss the transition. We understand the effort required to complete the accreditation process and will be ready to assist programs with timely submission of the Compliance Application in accordance with the new edition.

The FACT-JACIE Standards Steering Committee meets in Orlando to review the 7th edition draft Standards.

 

 

 

 

 

 

 

 

FACT Standards for Immune Effector Cells, 1st Edition

The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy. To ensure both sets of Standards include the most up-to-date requirements in this new field, requirements will be published in an interim version of the 1st edition Immune Effector Cell Standards. Once effective, the updated version of the Standards will be the basis of inspections going forward.

A list of the small number of changes to the Immune Effector Cell Standards will be provided at the same time the 7th edition Hematopoietic Cellular Therapy Standards are published in March 2018.

FACT Common Standards for Cellular Therapies, 2nd Edition

The FACT Common Standards for Cellular Therapies is currently undergoing revision. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy.  This includes hematopoietic progenitor cell (HPC) transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. A draft for public review and comment is expected in April 2018.

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, 7th Edition

The Steering Committee for the 7th edition of NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration will initiate the development process at the 2018 BMT Tandem Meetings in February.

FACT and WMDA-NetCord invite you to complete a short survey focused on general concepts of interest regarding the Standards. The results of this survey will be reported to the Standards Steering Committee for review and consideration as it begins to draft the next edition. Your input helps maintain the clarity, usefulness, and relevance of the Standards. Responses will be accepted through December 29, 2017. The 7th edition is scheduled for publication in October 2019.

Complete the survey

 


Upcoming Educational Events

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

FACT Immune Effector Cellular Therapy Inspection and Accreditation Workshop at SITC Annual Meeting
Thursday, November 9, 2017
National Harbor, MD
This training workshop is designed to educate participants on two key perspectives: building quality into their immune effector cell programs and performing peer-based inspections. FACT’s mission is to improve the quality of cellular therapy programs and depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.

Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.

View meeting details and register online

WMDA-NetCord Webinar: Manual and Automated Methods for Thawing of Cord Blood
Wednesday, November 29, 2017
Webinar

This WMDA-NetCord webinar is November 29, 2017, at 11:00 ET. Cellular therapy departments must thaw cord blood units, and they often use very different processes from the procedures outlined by the cord blood bank providing the unit. These SOPs are sent by the cord blood bank and are not always adapted to the disposals and reagents used by the department who then thaw the units. Diane Fournier, PhD, of Héma-Québec, and Roger Horton, PhD, of The Anthony Nolan Cord Blood Bank, will discuss manual and automatic thawing methods used by different departments for thawing of these units, and what can be done to improve recovery of the cells. Also, a multi-center study for harmonization of post thaw analysis of CD34 and CD45 cells will be presented.

View meeting details and register online

FACT Immune Effector Cellular Therapy Inspection and Accreditation Workshop at ASH Annual Meeting
Friday, December 8, 2017
Atlanta, GA

This training workshop is designed to educate participants on two key perspectives: building quality into their immune effector cell programs and performing peer-based inspections. FACT’s mission is to improve the quality of cellular therapy programs and depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.

Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.

View meeting details and register online

WMDA-NetCord Webinar: Cord Blood Outcome Data: How to Get it and How to Use it
Wednesday, December 13, 2017
Webinar

This webinar is December 13, 2017, at 10:00 ET. It is often difficult for cord blood banks to obtain outcome data following administration. Gesine Koegler, PhD, of the José Carreras Cord Blood Bank in Düsseldorf, and Andrea Darrow, Quality Manager at Cryo-Cell International, will discuss how to get and how to use cord blood outcome data. What have banks done that work well? And, once the information is received, how can it be used?

View meeting details and register online

QM Series 8: Staff Involvement in Document Control: Where do YOU fit in?
Wednesday, January 10, 2018
Webinar

This webinar is January 10, 2018, at 11:00 am ET. Mary Ann Kelley, DFCI, Associate Director of Quality Assurance CMCF at Dana Farber Cancer Institute / Cell Manipulation Core Facility, will discuss how staff is critical in the document control process, including developing, revising, reviewing, training, and accessing records. It will include information about protocols, and how to give staff access if programs rely on protocols instead of programmatic SOPs. This is the second webinar in the QM Series, Module 8.

View meeting details and register online

Applying the FACT Cord Blood Standards in Private Banking
Wednesday, January 17, 2018
Webinar

This webinar is January 17, 2018, at 9:00 AM ET. Elisabeth Semple, PhD, Cord Blood Bank Director at Cells for Life Cord Blood Institute Inc., Arvin Faundo, MD, Cord Blood Bank Director at Cordlife Group Limited, and Alexander Platz, MD, Cord Blood Bank Director at DKMS Cord Blood Bank, will discuss how family cord blood banks can comply with the NetCord-FACT 6th Edition Cord Blood Standards, methods to overcome challenges, and the benefits to achieving FACT accreditation.

View meeting details and register online

QM Series 8: The Digital Age: Controlling Documents within an Electronic System
Wednesday, January 24, 2018
Webinar

This presentation is Wednesday, January 24, 2018, at 11:00 am ET. Rebecca Maddox, Compliance Coordinator at Mayo Clinic Florida, will discuss the following:

  • The advantages and disadvantages of using a system,
  • How to incorporate an electronic system into your program,
  • Considerations to take into account when evaluating systems,
  • How to assess a system for compliance with the FACT Standards, and
  • What works well with her electronic system and what surprises she encountered.

View meeting details and register online

WMDA-NetCord Webinar: Informed Consent
Wednesday, February 7, 2018
Webinar

This presentation is Wednesday, February 7, at 11:00 am ET, 4:00 pm GMT. Daniel Gibson, Bsc (Hons), LIBMS, and Linda Moss, RM, of Anthony Nolan Cell Therapy Centre, will thoroughly review the different methods banks use to obtain informed consent, and the pros and cons of each method.

View meeting details and register online

FACT Cellular Therapy Inspection and Accreditation Workshop
BMT Tandem Meetings
Tuesday, February 20, 2018
Salt Lake City, UT

The blood and marrow transplant field has been a leader in voluntarily improving quality, and accredited Clinical Programs are currently adapting to several new FACT Standards and procedural changes to the accreditation process. This workshop will provide background on these changes. The morning workshop sessions include major topics such as how to effectively transition to the 7th Edition Hematopoietic Cellular Therapy Standards, CIBMTR data audits, clinical outcomes including center reported causes of low survival, and the accreditation of immune effector cellular therapy programs.

The afternoon session includes two different tracks: New Inspector Training Orientation and Common Citations. The Inspector Training track includes sessions on the FACT accreditation process, what documents to review before an inspection, the ins and outs of performing an onsite inspection, how to conduct an exit interview, and finally, how to make your case via the inspection report. The Common Citations track will review recent deficiencies and corrections related to commonly cited Standards in the areas of quality management, personnel, and donor information and consent to donate. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.

Note: Inspector trainees are required to attend the New Inspector Training Orientation Track.

View meeting details and register online

Cellular Therapy Leadership Course at BMT Tandem – 101
Tuesday, February 20, 2018, 8:00 am – 12:00 pm
Salt Lake City, UT

Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome.

In years past, participation in FACT’s leadership workshop has been by invitation. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.

The highly interactive and participatory curriculum teaches leadership principles 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
  • Running and participating in effective meetings
  • How to build consensus
  • Four proven ways to motivate people
  • Effective delegation skills
  • How to adapt to change, and even be a change agent
  • Understanding and exercising governance roles and responsibilities

Woven throughout the leadership course is an overview of FACT’s organizational structure, purpose, challenges, current programs and accomplishments.

Whatever you lead, this course is designed to help you recognize 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.

View meeting details and register online

Advanced Cellular Therapy Leadership Course at BMT Tandem – 201
Tuesday, February 20, 2018, 1:15 pm – 4:30 pm
Salt Lake City, UT

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

This advanced workshop drills deeper into organizational development and leadership skills. Topics include:

  • Characteristics of a healthy organization
  • Adapting an organization to a changing environment
  • Multiplying and diminishing the effectiveness of a team
  • Leading from where you are
  • Servant leadership
  • Effective governing boards
  • Legal implications of decision-making and liability and fiduciary responsibilities
  • Strategic planning with a focus on outcomes

Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.

View meeting details and register online

Cellular Therapy Collection Workshop at ASFA Annual Meeting
Wednesday, April 25, 2018
Chicago, IL

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities. FACT representatives will be in attendance to 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.

View meeting details and register online

 

Cellular Therapy Inspection and Accreditation Workshop at ISCT Annual Meeting
Tuesday, May 1, 2018
Montreal, Quebec, Canada

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.

The afternoon session will include two different tracks (to be arranged). All sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.

View meeting details and register online


FACT Achieves Major Accomplishments in 2016

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

The 20th year of FACT successfully built upon its history of successes to advance cellular therapy and regenerative medicine. As physicians and scientists continue to make advancements, opportunities arise for FACT to play a supporting role to educate all programs on new approaches and therapies. The following are highlights from 2016:

1. FACT Celebrates 20th Anniversary

FACT celebrated its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. FACT welcomed visitors to a dynamic exhibit booth at the BMT Tandem Meetings and the ISCT Annual Meeting to celebrate with the organization. Attendees who wore their commemorative FACT 20th anniversary pin received gifts and were entered in a daily drawing for prizes.

FACT also hosted anniversary receptions at these meetings, and many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and refreshments as FACT celebrated two decades of working together in the community to improve patient care and safety. Guests enjoyed watching a short video highlighting FACT’s past 20 years, and saw some familiar faces who have been an integral part of FACT since its beginning.

2. FACT Commences Review of Corrective Action Plans for Low One-Year Survival

The FACT Clinical Outcomes Improvement Committee began formally reviewing corrective action plans submitted by Clinical Programs that did not meet expected one-year survival as outlined by comparative data. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients. After several months of reviewing corrective action plans, the committee has articulated its expectations for these plans using six guidelines:

  • The corrective action plan must identify specific causes of death.
  • The corrective action plan must provide quantitative data.
  • The assessment must identify reasonable causes of the low one-year survival rate.
  • The corrective action plan must address the identified causes.
  • There must be a measurable outcome improvement.
  • The program must provide updates on corrective actions at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee.

3. FACT Presents Comments at FDA Hearing

The Food and Drug Administration (FDA) hearing to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) occurred on September 12-13, 2016. Dr. Phyllis Warkentin spoke on behalf of FACT and presented the following comments to the FDA:

  • FDA should fulfill its responsibilities to protect patients in search of cellular therapies. FACT supports its parent society, the International Society for Cellular Therapy (ISCT), in its position on unproven therapies and agrees on the importance of providing adequate education for patients. Development of professional standards and voluntary accreditation can play an important role in providing a bridge from basic research to clinical application.
  • The tiered unified approach to HCT/P regulation fails to acknowledge the complexity of some tissues with multiple native functions and many cell types. It is difficult to strictly categorize complex tissues such as adipose tissue as only structural or cellular. Dr. Warkentin offered solutions for applying regulations to such tissues.
  • There appear to be some inconsistencies in the definitions and examples of homologous use that would benefit from clarification.
  • FACT suggests that the Agency expand upon its expectation for cord tissue, to include which regulations apply and when they apply, based upon the processes in place.
  • International harmonization is important to facilitate product development and world-wide availability of cell-based therapies for patients.

4. Sixth Edition NetCord-FACT Cord Blood Standards Published

NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and its accompanying Accreditation Manual on July 1, 2016. These Standards became effective after 90 days, and all accredited cord blood banks were required to comply with the requirements by that time.

These Standards cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage, including quarantine, testing, and characterization of the cord blood unit; 4) making the cord blood unit available for administration, either directly or through listing with a search registry; 5) the search process for selection of specific cord blood units; 6) reservation and release of cord blood units for clinical use;  and 7) all transport or shipment of cord blood units, whether fresh or cryopreserved.

5. Draft 1st Edition Immune Effector Cell Standards Published for Public Comment

FACT published a draft of the 1st edition FACT Standards for Immune Effector Cells for inspection and public comment in July 2016. Interim standards for the 6th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration were also proposed to include immune effector cell programs within blood and marrow transplant units. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field.

The Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Commenters included, among others, pharmaceutical companies, the FDA, the American Society of Cell & Gene Therapy (ASGCT), and the Society for Immunotherapy of Cancer (SITC). A total of 131 comments were received, and reviewers generally expressed support for the Standards and posed worthy questions to consider.

6. CYCORD is First Cord Blood Bank in Cyprus to Earn FACT Accreditation

CYCORD Public Allogeneic Cord Blood Bank in Cyprus received internationally recognized FACT accreditation.  CYCORD, directed by Paul Costeas, PhD, is the first and only cord blood bank in Cyprus to be recognized by FACT.  The bank received accreditation on June 13, 2016, and is accredited for banking cord blood for both public and private family use.

7. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario is First Cellular Therapy Program in Mexico to Earn FACT Accreditation

Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario in Mexico received internationally recognized FACT accreditation. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario, directed by David Gomez-Almaguer, MD, is the first and only cellular therapy program in Mexico to be recognized by FACT.  The program received accreditation on September 6, 2016, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.

8. StemCyte India Therapeutics is First Cord Blood Bank in India to Earn FACT Accreditation

StemCyte India Therapeutics Cord Blood Bank, directed by Bhavin Kapadiya, MD, is the first and only cord blood bank in India to be recognized by FACT. The bank received accreditation on December 21, 2016, and is accredited for banking cord blood for both public and private family use.

9. FACT Hosts Quality Initiatives with Parent Organizations

FACT hosted a Quality Boot Camp at the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The goal of the boot camp program is to strengthen quality assurance activities through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee encouraged registrants in the months leading to the in-person workshop to review specific aspects of their quality programs. Quality experts then presented important concepts and led roundtables that allowed participants to ask questions and help each other reach their goals during the boot camp. FACT also partnered with ISCT at their regional meeting to co-host sessions in the Quality and Operations Track. Presentations focused on outcome analysis from the processing perspective and the anatomy of an audit.

10. New Webinar Collaboration Between ASHI and FACT

FACT and the American Society for Histocompatibility (ASHI) began collaborating to offer webinars on transplant immunology. Establishing best practices in transplant immunology in different parts of the world requires both deep understanding of the unique challenges that face different parts of the world, and building on the experiences of well-established labs and international histocompatibility professional societies.

11. FACT Joins Standards Coordinating Body as a Charter Member

The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts.  More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).