Just the FACTs, 2019 Volume 5
It’s hard to believe that we’re nearly half way through the year; in seven months we begin “the 20’s!” In this month’s newsletter, you will see FACT’s upcoming worldwide activities! We hope to see many of you soon at the FACT workshop and quality boot camp at the ISCT annual meeting in Melbourne on May 28th and 29th. In June, FACT visits our colleagues in the north to host an accreditation and inspection workshop at the Canadian Blood and Marrow Transplant Group (CBMTG) meeting. July brings a trip to Brazil where FACT will host another workshop at the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) Meeting. As summer winds down and we head into September, FACT is excited to hold a special cord blood day with the WMDA-NetCord Cord Blood Working Group at the second annual Cord Blood Connect International Congress in Miami. Also in this issue you, is an article on inspector recruitment, and I encourage each of you to be recruiters for FACT and the community. Simply tell your story of all you derive from visiting programs including, networking, examples of practices to adopt, and intimate familiarity with the FACT Standards. As always, every season is Standards season, and FACT is preparing to publish the seventh edition of the Cord Blood Standards on October 15, 2019.
I’m preparing for an inspection in the new accreditation portal this month, and I think you will find the portal intuitive, fast, and consistent. I’m really pleased with it, and I hope you will be too.
Articles in this issue include:
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- Prepare for the NetCord-FACT International Cord Blood Standards, Seventh Edition
- Growing Demand for FACT Inspectors
- The Countdown is on to Register for FACT Events at the ISCT Annual Meeting!
- FACT Partners with the Brazilian Bone Marrow Transplant Society on Accreditation Workshop
- WMDA-NetCord & FACT Cord Blood Day at the Cord Blood Connect International Congress
- New Volunteer Committee Members
- FACT Accreditation Portal Update
Sincerely,
Dennis Gastineau, MD
FACT President -
Prepare for the NetCord-FACT International Cord Blood Standards, Seventh Edition
By: Andra Moehring, MHA, FACT Standards Development Manager
The Seventh Edition NetCord-FACT International Cord Blood Standards for Collection, Banking, and Release for Administration will be published on October 15, 2019 and will become effective on January 15, 2020.
Programs currently pursuing renewal or initial accreditation under the Sixth Edition Standards must remain mindful of these dates and ensure timely submission of pre-inspection materials and completion of the inspection. All cord blood banks obtaining accreditation under the Sixth Edition Standards must submit Compliance Applications and associated documents by October 15, 2019, and be inspected by January 15, 2020.
After October 15, 2019, materials for the Seventh Edition Standards will be available. The FACT Accreditation Services department has contacted accredited and applicant cord blood banks who will begin 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 banks with timely submission of the Compliance Application in accordance with the new edition.
If you have additional questions, please contact your FACT Accreditation Coordinator.
As FACT is preparing for the Seventh Edition Standards, we are here to help you do the same! The following upcoming events will provide information regarding changes made and how to comply:
Thursday, September 12, 2019: Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards presentation at the WMDA-NetCord & FACT Cord Blood Day at the Cord Blood Connect International Congress.
View meeting details and register
Wednesday, October 23, 2019: Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards webinar. 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 webinar details and register
Growing Demand for FACT Inspectors
As FACT accreditation expands both globally and in scope with the addition of immune effector cell therapy, a need exists for additional experienced, knowledgeable cell therapy professionals to serve as FACT inspectors.
Eligible personnel at accredited organizations are encouraged to consider the value-added benefits when you serve as a volunteer FACT inspector.
Exposure to Exemplary Practices
As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas from the facilities you inspect and your interaction with experts on your inspection team. There’s also evidence that organizations that don’t have an inspector have more difficulty complying with current standards.
Free Access to FACT Educational Resources
Volunteer inspectors have free access to both in-person and online educational events with an annual value of $1,840.
Contributions to Standards Development
Inspectors have greater opportunity to contribute to the development of FACT Standards. The opinions of FACT inspectors are always sought early in the process of developing new editions of standards and accreditation requirements. Eligibility of key FACT committees also requires that members be, or have been, a FACT inspector.
Professional Development
Your organization will appreciate your skills and experience when you serve as a volunteer FACT inspector. “FACT Inspector” also looks great on a curriculum vitae!
The American Society for Transplantation and Cellular Therapy’s (ASTCT) new elite Leadership Course designed to provide training and develop the next generation of leaders in the field of blood and marrow transplantation and cellular therapy encourages selected participants to serve as a FACT inspector.
Join our Team – Apply to be a FACT Inspector
Information about qualifications and how to apply to become a FACT inspector can be found at www.factwebsite.org/becomeinspector. If you have any questions, don’t hesitate to contact the FACT office.
The Countdown is on to Register for FACT Events at the ISCT Annual Meeting!
Register Now and Save!
FACT Accreditation Workshop
Join your fellow cellular therapy and cord blood colleagues for several FACT events at the 2019 ISCT Annual Meeting in Melbourne, Australia. On May 28th FACT will host a Cellular Therapy and Cord Blood Inspection and Accreditation Workshop from 8:00 am to 5:00 pm. This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management. Register before May 28th and save $100!
Fees are waived for active and trainee inspectors. Apply to volunteer and train as a FACT inspector.
ISCT-FACT Quality Boot Camp
On May 29th ISCT and FACT will host a cellular therapy Quality Boot Camp for sessions that include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.
FACT Exhibit Booth
FACT representatives will be at exhibit booth #36 to provide information about FACT Standards and Accreditation. We would love to see new and familiar faces!
Exhibit Booth Dates and Times:
Wednesday, May 29th: 19:30 – 21:30
Thursday, May 30th: 09:00 – 19:30
Friday, May 31st: 09:00 – 18:30
Take advantage of these exciting FACT events by registering now! We look forward to seeing you in Melbourne!
FACT Partners with the Brazilian Bone Marrow Transplant Society on Accreditation Workshop
Members of the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) are invited to attend the FACT-SBTMO Cell Therapy Accreditation Workshop on Wednesday, July 31, 2019 during the XXIII Congresso da SBTMO in Brasília.
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 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 International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration 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
• Share the experience of an accredited Brazilian transplant center
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions
Date: July 31, 2019
Time: 8:00 to 13:15
Location: Hotel Royal Tulip Brasília Alvorada
SHTN Trecho 1 Blocos C Conj. 1 – Asa Norte
Brasília -DF 70800-200
Brazil
Register: FACT-SBTMO Accreditation Workshop
Register: 2019 SBTMO Congress
WMDA-NetCord & FACT Cord Blood Day – September 12, 2019 at the Cord Blood Connect International Congress
The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.
Topics will include:
- Global perspectives of the regulation of cord blood banking,
- WMDA serious adverse events and reactions,
- Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
- Analysis of cellular viability in thawed cord blood,
- Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
- Essential Quality Management Principles
The afternoon offers two tracks:
- WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
- FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!
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.
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- 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.
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- 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.
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- 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.
FACT Accreditation Portal Launch Update
FACT Accreditation Portal Launch Update
On October 1, 2018, FACT launched its new Accreditation Portal. FACTWeb applications already in progress must be completed in the legacy portal but all new applications are created in the new FACT Accreditation Portal. At this time 60% of our applicants have been migrated to the new portal. All of the beta test organizations for Annual Reports, Renewal Applications, and Eligibility Applications have completed their applications. The Compliance Application process is significantly longer, but three FACT beta testers have completed their compliance applications, inspections, and were reaccredited through the new portal.
A very special thank you to all the beta test organizations and their inspectors that continue to clear the way for other organizations and provide valuable feedback regarding their portal experience.
New to FACT
To apply for FACT Accreditation, navigate to the portal at https://portal.factwebsite.org and select “Create an Organizational Profile”.
First Time Users
Your credentials for the new portal are different from the sign-in information used to register for events and log into FACTWeb!
For the new portal, enter your email address as your username.
First time users can refer to the following guides:
If you do not receive the Reset Password email from portal@factwebsite.org, contact your FACT coordinator to confirm the email address on file.
Training Materials
With the launch of the new portal, FACT published How-To Guides to help mitigate the inevitable learning curve that comes with new technology. These guides are available in the Portal Resource Center. Since the launch, FACT published two new training videos to ensure applicants have on-demand access to portal training materials for every learning style.
*As an inspector, reviewing the training materials in the Portal Resource Center is strongly recommended.
Assistance
For questions related to your application, contact your organization’s assigned FACT coordinator or email FACT at fact@unmc.edu.
For technical assistance in the portal(s), contact FACT at portal@factwebsite.org
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
