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
New CARTOX App Assists Grading and Management of IEC Toxicities
By Sherry Adkins, RN, MSN, ANP-C and Kara Wacker, MBA, RAC
The CARTOX Mobile App for iPhone and Android, created by MD Anderson Cancer Center, is now available to assist clinicians with accurate and timely grading and treatment of toxicities associated with immune effector cellular therapy (IEC). The app is intended for physicians, nurse practitioners, physician assistants, nurses, and pharmacists who treat patients receiving IECs.
Sherry Adkins, RN, MSN, ANP-C, Advanced Practice Provider Supervisor, Lymphoma Research at the MD Anderson Cancer Center developed the idea of an app to allow for safer and more efficient care of the rapidly expanding population of patients receiving IECs. “We recognize that the app has helped our group improve the safety and efficiency of care for this group of patients,” explains Adkins. “We hope it will help other clinicians, particularly those who are just beginning to administer this therapy.”
Ms. Adkins led the implementation strategy with coding assistance from Darren Skeete and his team from the center’s Informational Technology (IT) department. Members of the MD Anderson CARTOX Committee, including Drs. Sattva Neelapu and Elizabeth Shpall, reviewed and tested the app. The process started in the Fall of 2017, and MD Anderson clinicians had access by August of 2018.
The app is based on published guidelines, and will continue to be updated as science evolves to reflect the most current practice guidelines. The initial version of toxicity grading was based on the MD Anderson’s CARTOX program guidelines, but has since been updated to reflect the ASTCT (formerly known as ASBMT) consensus grading. (Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25. Review.)
Toxicity management is based on the CARTOX program’s guidelines, which were developed by a multidisciplinary, multi-institutional group of clinicians (Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19. Review). Toxicity management guidelines are currently being updated and the mobile APP will be updated to reflect those changes in the near future.
To download the app, search for CARTOX in the Apple Store or Google Play.
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.
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
New FACT Accreditation Portal Launched
In 2015, FACT began a monumental undertaking to replace the FACTWeb Portal. FACT’s vision was to create a new system that would revolutionize the accreditation process. The goal was to improve the applicant’s ability to efficiently submit evidence to FACT; enhance the inspector experience with a streamlined approach for reviewing compliance applications, clinical outcomes, and data management; improve inspector training; and increase system flexibility to allow FACT staff to seamlessly manage the accreditation process from start to finish.
This past April, 10 organizations were selected to serve as beta testers and complete their applications in the new portal. After a successful beta test period, the new FACT Accreditation Portal launched on October 1, 2018.
“This is a major improvement over the first portal. The ease of use and the speed are complete upgrades! I appreciate everything that was incorporated into this new portal and realize that we will continue to strive to improve it. Very pleased to have been a beta tester!” states Kim Kasow, DO of the UNC Bone Marrow Transplant and Cellular Therapy Program.
Applicants with pre-existing applications in the legacy FACTWeb portal will continue with the legacy portal until the current application is finished. Going forward, all new applications will be created in the new FACT Accreditation Portal.
FACT Accreditation Portal
Portal access: https://portal.factwebsite.org
- To apply for initial FACT accreditation, complete the request for access form accessible from the new portal login page.
- If your organization has been migrated to the new portal, complete the Recover Password form accessible from the new portal login page to access your account.
Training Materials: Portal Resource Center
Launch Details: FACT Accreditation Portal Launch Updates
Legacy FACTWeb
To access an existing application in the legacy FACTWeb portal, navigate to https://www.factweb.org.
Acknowledgements
A very special thank you to all the people that contributed to this project:
- The FACT Technology Committee for their leadership and guidance throughout the project
- Our Beta Testers who courageously entered the new portal and took the time to explore and provide feedback
- FACT Staff for their patience through countless meetings, working sessions, and months of testing
- Our software developer, 5th Method, for their support and partnership throughout this project
FACT Prepares for New Portal Launch
By Alisa Forsythe, IT Business Analyst
In 2015, the FACT Technology Committee committed to replacing the FACTWeb Portal. This April, after three years, the first users logged into the new FACT Accreditation Portal. Ten different organizations were selected to serve as beta testers and complete their applications in the new portal.
Feedback on the new portal has been positive:
- “So much faster than the old portal. It is nice that the tabs do not stay open as you move along the application. […] I generally am not a fan of being a beta site, but in this case, I am glad we are as this portal is such an improvement.”
– Karen Klinker, Dana-Farber Cancer Institute/Brigham and Women’s Hospital Adult Hematopoietic Stem Cell Transplant Program
- “Easy to move between application components. Easy to see where you are within the application. Color coding is very helpful.”
– Peggy Appel, Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital
- “The new portal is so easy to work with and is a vast improvement from the previous system. It is much easier and quicker to go to the next question and to maneuver around in the portal. Thank you for your hard work in developing this new portal!”
– Sue O’Donnell, The Massachusetts General Hospital Bone Marrow Transplant Program
- “This is a major improvement over the first portal. The ease of use and the speed are complete upgrades! I appreciate everything that has been put into this new portal and realize that we will continue to strive to improve it. Very pleased to have been a beta tester!”
– Kim Kasow, UNC Bone Marrow Transplant and Cellular Therapy Program
With a successful beta test underway, the new FACT Accreditation Portal is scheduled for launch this August.
Upcoming Training Sessions
Online training opportunities are now available on the FACT Event Calendar. Advance registration is required. The first training session of each type will be recorded and made available online for on-demand viewing.
- Completing an Annual/Renewal Report in the Portal
- Completing a Compliance Application in the Portal
- Performing an Inspection in the Portal
Ensure Receipt of FACT Communications!
By Alisa Forsythe, IT Business Analyst
Email filters are critical to protecting business information systems, but, ironically, sometimes those filters can be overprotective and stop important messages from reaching your inbox.
In an effort to provide real-time, accessible, and environmentally and economically friendly information, FACT connects with its stakeholders from three main domains. All of these domains must be able to pass your email filters. If you received this newsletter via email, you likely do not have a problem. However, it is highly possible that your colleagues do. We strongly recommend you add FACT to the “white list” (sometimes referred to as a “safe list” or a “safe sender list”) of every colleague at your institution who should receive FACT information.
FACT domains that need whitelisted include:
- New accreditation portal email address (portal@factwebsite.org)
- The FACT store (smtp.fact.matrixmaxx.com)
- Newsletters (mailingmaxx.factweb.org)
Emails generated from the FACT accreditation portal contain very important information, such as notifications, approval requests, and webpage links. The FACT store sends emails related to meeting registrations and online purchases, including free downloads. Newsletters, including this quarterly newsletter and weekly digests, provide information both critical and helpful for successfully achieving and maintaining compliance with FACT requirements.
Based on the security settings of your institution’s personnel accounts, it is possible that you will need to enlist the help of your Information Technology department. If you are able to whitelist email senders yourself, or if you use a personal email account for FACT correspondence, the following are helpful instructions:
- Instructions for all email providers: http://sci.scientific-direct.net/wl.html
- YouTube Video for Hotmail/Outlook/Live: https://www.youtube.com/watch?v=0QGUNQv9kcg
After adding FACT’s domains to your whitelist, your email system may still attempt to filter FACT messages by sorting them into junk or clutter folders. If you do not receive an expected email from FACT and have already added us to your whitelist, check those folders. If ever in doubt, contact your FACT Accreditation Coordinator or the FACT office (fact@unmc.edu, 1-402-559-1950).
