Current Quality Management Webinar Series on Embracing Change: Growing Your Cellular Therapy Services
The theme for Series 12 of FACT Quality Management Webinars is embracing change. Each webinar will equip organizations with practical strategies and insights to successfully incorporate a new service or product into your cellular therapy organization while ensuring compliance, optimizing patient outcomes, and driving continuous improvement.
There will be two parts for this series. Part I of the series in 2023 includes the following webinars:
- July 13 – Facility Needs Assessment & Change Control (recording)
- September 27 – Establishing Quality Indicators
- November 14 – Written Agreements
- TBD – The cellular therapy organization’s perspective on these topics
Registration is available for each webinar individually using the links above, or bundle and save 15% on the full series! The bundle can be purchased at QM Series 12 Webinar Bundle.
Don’t Miss Out on Early Bird Pricing for the FACT – ASTCT Quality Boot Camp!
We invite you to attend the FACT – ASTCT Quality Boot Camp on Wednesday, February 15, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, FL. This is a collaborative event where you will participate in a series of roundtable activities supplemented with presentations facilitated by experienced FACT inspectors and quality personnel.
The theme of the FACT – ASTCT Quality Boot Camp is: Strengthen your Quality Management Program through the Effective Use of Quality Tools. Using the right quality tool can help reduce errors, improve communication, help maintain compliance, and save programs time and resources while improving the overall quality of your program and processes.
During the quality boot camp, FACT instructors will discuss tools and techniques most commonly used in quality management and process improvement including:
- SWOT Analysis (Strengths, Weaknesses, Opportunities, and Threats)
- Risk Assessment and Failure Mode and Effects Analysis (FMEA)
- The Five Whys
- Fishbone/Ishikawa Diagram
Quality Management Series 11: Corrective Action Plans
Implement and Assess Effectiveness of Corrective Action Plans
August 24, 2022
Join us on Wednesday, August 24, 2022, at 11:00 ET/17:00 GMT, for the FACT QM 11 Webinar: Implement and Assess Effectiveness of Corrective Action Plans. Presenters will discuss:
- Implementation of corrective action plans.
- Monitoring corrective action plans. Assessing the effectiveness of a corrective action plan.
Presenters:
Folashade Otebeye, MBChB, MPH
Fred Hutchinson
Kerri Hill, BSN, RN
UAMS Cancer Institute
Corrective Action Plans: Program Perspective
November 9, 2022
Join us on Wednesday, November 9, 2022, at 3:00 pm ET/21:00 GMT, for the FACT Quality Management Series 11 Webinar: Program Perspective. Presenters will discuss corrective action plans from the Clinical, Collection, Processing, and Cord Blood Bank programs’ perspectives.
Presenters:
John McCarthy, MD
VCU Health
Leigh Gates, CPHQ
University of Colorado
Phillip Johnson, MMedSc(Path)
Queensland Cord Blood Bank at the Mater
Additional webinars in this series are open for registration at the following links. Advance registration and post-webinar recordings of all webinars in this module can be purchased at a discounted rate.
Other webinars in this series include:
- Overview of Corrective Action Plans (February 16. 2022)
- Developing a Corrective Action Plan (May 11, 2022)
Corrective Action Plans the Focus of this Year’s Quality Management Webinar Series
The 11th module of the Quality Management Series is all about corrective action plans.
The first webinar, hosted on February 26th, was, Overview of Corrective Action Plans. Dr. Carlos Bachier from Sarah Cannon Transplant and Cellular Therapy Program at Methodist Hospital in San Antonio, and Lisa Cantwell MHA, CPHQ from the Blood & Marrow Transplantation Program of the Holden Comprehensive Cancer Center at the University of Iowa, discussed the following:
- When a corrective action plan is needed
- The purpose of a corrective action plan
- Who should be involved
- Short term immediate corrective action, and long-term preventive correction action
- How to assess the effectiveness of a corrective action plan
Additional webinars in this series are open for registration at the following links. Advance registration and post-webinar recordings of all webinars in this module can be purchased at a discounted rate.
- Developing a Corrective Action Plan (May 11, 2022)
- Implement and Assess Effectiveness of Corrective Action Plan (August 24, 2022)
- Corrective Action Plans, A Program’s Perspective (November 9, 2022)
The X Factor: What is GxP and What Training is Required?
The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C4.4.2.5, and D4.4.2.5).
What is GxP?
The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”
Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).
What GxPs require annual training per the Standards?
FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.
All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).
How much training is required each year?
Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.
Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual
Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 3)
By Stacy Freeburg, FACT Accreditation Coordinator
How do you maintain audits, various consent forms, and other documentation?
Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service
Our quality management system, Q-Pulse, has been fantastic for maintaining audits, documents, non-conformances, supplies, equipment, and now training courses. We are a central system overseeing 2 pediatric FACT-accredited sites and 12 nationally accredited sites (National Association of Testing Authorities, Australia/National Pathology Accreditation Advisory Council [NATA/NPAAC]). Without this tool, we would not exist. It automates actions, creates workflows, and emails notifications. I really like how easy it is to modify drop downs to meet our requirements without information technology upgrades or database changes. It is also very intuitive for staff, which makes training and day-to-day use very easy. I used to work for the national body, NATA, and I saw a lot of very complicated software packages-at accredited sites. Many were not well used!
Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital
Maintenance of audits, consent forms, and labeling is assigned to various quality designees, as applicable. Our programmatic Standard Operating Procedures (SOPs) describe established processes for follow-up and reporting to ensure the audits are completed in a timely manner. SOPs dictate processes for consent updating and review. Check-off and time-out processes ensure labeling is completed per standards and regulatory guidance. The quality designees work with physicians, supervisors, and clinicians to maintain compliance with FACT standards impacting the daily duties of staff members. The integration into daily practice creates a quality-focused program, with built-in and evolving checks and balances throughout the program’s departments to ensure consistency of processes and procedures.
Share strategies for staying up to date on upcoming changes to the Standards and what tools you use to communicate those upcoming changes within your organization.
Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service
Generally, this is done via Q-Pulse. We have had specific training sessions across our network, which have focused on donor work-up, ISBT 128 labelling, and GMP requirements.
An Immune Effector Cell (IEC) Quality Manager focuses purely on IEC rather than both Hematopoietic Progenitor Cell (HPC) and IEC. This has assisted in developing IEC-specific SOPs and processes. This is such a growing area that I believe it needs individual attention.
Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital
Monthly meetings are conducted to discuss regulatory topics, including any updates to the FACT Standards. Key personnel from the clinical, collection, and processing facilities participate in the monthly meetings. Consistent monitoring of the FACT newsletter and disseminating pertinent updates occurs during these meetings. Note, our programmatic SOPs outline how updates need to be conveyed to the program, reviewed with the FACT Program Director, and distributed to the program through an appropriate conduit based on the impact and urgency of the change.
Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation
Maintain a spreadsheet or utilize OneNote or a similar tool that crosswalks the FACT Standards to your SOPs. FACT provides an Excel download of all standards and related questions, called the Self-Assessment Tool, in the portal that can be used to prepare for the accreditation process. If a new edition of Standards is finalized during the organization’s accreditation cycle, organizations can use the crosswalk FACT provides to update its internal crosswalk to SOPs (available on the FACT website).
For additional information, download and view the educational recording, QM Series 8: The Document Control Process From Start to Finish (and Back Again!) (FACT), September 13, 2017.
Thank you to the following contributors for sharing their tips and lessons learned from their experiences at a FACT accredited program:
Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital
Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service
Elisha Nixon, Quality Program Manager, Walter Reed National Military Medical Center, Murtha Cancer Center Research Program, Uniformed Services University of the Health Sciences, The Henry M. Jackson Foundation
Register for the FACT-JACIE and WBMT Webinar: Quality and Accreditation for Cellular Therapy: A Global Perspective
Quality Management Series, Module 10: Validations
The Quality Management Series Module 10 includes four sessions focused on Validation including:
Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT
Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.
Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT
Presenters will discuss the following:
- Range to validate (where to start and when to stop), variables and extreme scenarios
- Process validations (to include Bone Marrow process)
- Verification: when is it needed
Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT
Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:
- Critical electronic systems under the control of the organization (facility)
- Spreadsheets
- Vendor and organization responsibilities
Program Perspective on Validation
TBA
Register for the entire module to receive a 15% discount! QM Series Module 10: Validations
FACT Announces New Quality Management Series, Module 10: Validations
The Quality Management Series Module 10 includes four sessions focused on Validation including:
Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT
Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.
Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT
Presenters will discuss the following:
- Range to validate (where to start and when to stop), variables and extreme scenarios
- Process validations (to include Bone Marrow process)
- Verification: when is it needed
Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT
Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:
- Critical electronic systems under the control of the organization (facility)
- Spreadsheets
- Vendor and organization responsibilities
Program Perspective on Validation
TBA
Register for the entire module to receive a 15% discount! QM Series Module 10: Validations
2020 FACT-ASTCT Quality Manager Engagement and Resiliency Survey
Resilience is the ability to recover from or adjust easily to change. Highly resilient individuals thrive in an environment of change. The Quality Manager’s capacity to be resilient during change, a constant in their work life, is a critical skillset.
Since 2017, the FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group have collaborated to identify opportunities to increase the QM’s resiliency. During that year, the quality groups developed an anonymous survey to collect data on Quality Manager personal resilience and their perceived benefits of improved resilience. The survey included a validated “Brief Resilience Scale”2 (BRS) which quantitatively measures resilience (1 = low to 5 = high).
To assess possible work stressors, Quality Managers were queried about their responsibilities, program size/complexity, and the nature of interactions with others, e.g. direct supervisors. Respondents were also asked to rank selected resources for increasing resiliency.
Since that initial survey, results have been analyzed and presented as abstracts during TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR. Additionally, survey findings have been used to identify resources to help, among others, build resilience through improved workplace communications, workload management. This resources list was uploaded to the FACT website at: http://www.factwebsite.org/WorkArea/DownloadAsset.aspx?id=1898.
It’s come time to reassess…Quality managers, we need you!
The committees are reaching out more broadly to cellular therapy program and cord blood bank Quality Managers around the world requesting that you complete a follow-up survey. This year’s anonymous survey takes approximately 20 minutes to complete. The survey can be accessed at the web address or by scanning the QRS code included below.
https://www.surveymonkey.com/r/FACT-ASTCT2020QMResiliency
The FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group plan to analyze information provided by respondents later this year and publish early in 2021.
Final Webinar in the Quality Management Series, Auditing
February 5, 2020
3:00 pm ET, 20:00 GMT
Join FACT for the final webinar in the ninth Quality Management Series, Auditing. Phillip Johnson, MMedSc(Path), Production Manager at Queensland Cord Blood Bank at the Mater, Sylvia Dulan, RN, MSN, MBA, PMP, HCT Regulatory and Quality Management Specialist at City of Hope Hematopoietic Cell Transplantation Program, and Ann Wilson, MHA, MT(ASCP)SB , Lab and Quality Manager at Scott & White Autologous Transplant Program, will give an overview of their program’s audit process and how they write audit reports.
The first three webinars within the module are available for download in the FACT store:
- QM Series 9: Auditing: Planning and Executing
- QM Series 9: Auditing: Summarizing and Evaluating the Data
- QM Series 9: Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors
Stay tuned for the next QM Series 10, Validations! Topics include Validation Overview, Process Validation, Software Validation, and Program Perspectives on Validation.
FACT Announces ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting – September 12
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
Education Events
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 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
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
New Volunteer Committee Members
Annually, FACT distributes a Call for Volunteers to solicit new committee members for its Standing and Special Committees.
The FACT Board of Director strives to have a 20% turnover each year in committee membership to provide new opportunities for those interested in becoming more involved with FACT as well as to interject fresh and innovative perspectives in working groups.
It is always moving to see the numbers of volunteers willing to devote their personal time in light of increasingly busy schedules. Although there are typically not enough positions available to place all volunteers on a committee, we retain the information of volunteers to appoint to committees in subsequent years.
Following are the FACT Committees that had vacancies this year and their new members:
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.
- Nicole Acqui, MD
- Alex Babic, MD, PhD
- Guy Klamer, PhD
- Yogesh Jethava, MBBS
- Premal Lulla, MD
- Joseph Lynch, MD
- Huy Pham, MD, MPH
- Priti Tewari, MD
Quality Management Committee
Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.
-
- Sylvia Dulan, RN, MSN, MBA, PMP –
- Kris Michael Mahadeo, MD, MPH
- Omotayo Fasan, MBBS, MRCP
- Krista Holcomb
FACT-CIBMTR Data Audit Committee
Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.
-
- Jaskiran Kaur, CQA(ASQ)
- Linh Sellers, CCRP
- Hemant Murthy, MD
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.
-
- Leon Su, MBA, FCAP, FASCP
- Shanlong Jian, BS, MS
- Federerico Rodriguez Quezada BSMT, SBB(ASCP)
The contributions of our volunteer committee members has been invaluable and has resulted in the tremendous success of FACT. Thank you to all our volunteers for your dedication and support of FACT to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.
Education Events
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
Call for FACT Volunteers
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
