By Suzanne Birnley, MS, MBA, FACT Accreditation Services Manager
It has been a very busy few months at FACT between the implementation of virtual inspections and publishing the eighth edition of the FACT-JACE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. These developments have led to some changes and improvements to the FACT Accreditation Process.
- Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. All applicant programs and banks are now required to submit additional documentation in preparation for their FACT inspection. For applicants currently waiting for their inspection to be scheduled, these documents can be uploaded in the FACT Accreditation Portal Document Library under the Virtual Inspection Documents tab. These documents are expected to be submitted a minimum of 4 weeks prior to the inspection. These additional submissions have been included with the Eighth Edition Hematopoietic Cellular Therapy (HCT) Compliance Application, and will be included in other Standards as new editions are published. These include:
- A copy of all policies and Standard Operating Procedures referenced in the Quality Management Plan.
- The most recently completed Annual Report on the Effectiveness of the Quality Management Program.
- Whether for a virtual inspection or on-site, beginning July 1, 2021, all programs are required to use OneNote or the equivalent to organize documents for their inspection. This can be accomplished in several ways:
- Use the OneNote template provided by FACT.
- Use a software developed within the organization or a commercially available software.
- Use the FACT Self-Assessment Tool or checklist from your completed application in the FACT Accreditation Portal, and add additional columns for links to documents and information regarding where to find documentation of compliance for each standard.
- For on-site inspections, use the binder method. Match each standard to the documentation of compliance in paper form, all organized by standard in three-ring binders.
- For virtual inspections, beginning July 1, 2021, all programs are required to use a document camera to display documentation that exists in paper format. This is particularly important in collection or processing facilities that use paper records.
Finally, it is very important that inspectors have access to any updated documents, especially if the Compliance Application was completed a year ago. FACT Accreditation Coordinators will send Requests for Information (RFIs) to update documentation known to be out of date, such as medical licenses and continuing education. It is your responsibility to let your coordinator know if there are any other policies or SOPs that were submitted that have since been revised. If inspectors do not have access to these documents, it is a risk that they may not see evidence of compliance, resulting in deficiencies cited on the Accreditation Report.
FACT greatly appreciates the hard work of the inspectors and applicants as we transition through this challenging time. We do intend to return to on-site inspections as soon as it is safe to do so. We are actively seeking and welcoming feedback on both the virtual inspection process and these process changes. If you have any questions or concerns, please contact your Accreditation Coordinator or the Manager of Accreditation Services, Suzanne Birnley.
Some commercial cellular therapy product manufacturers may provide FACT-accredited programs the option to undergo a full site quality audit or provide a copy of the most recent FACT accreditation report and undergo an abbreviated audit. If choosing the second option, programs will want to provide manufacturers the final report complete with program responses to cited deficiencies. Program responses are an opportunity to demonstrate correction of deficiencies and ultimate compliance with FACT Standards.
FACT Accreditation Coordinators will provide a copy of the final Accreditation Report, with the program’s responses, when sending the Accreditation Certificate at the conclusion of the inspection and accreditation process. Additionally, in the current online accreditation portal, the complete report can be downloaded by opening the applicable Compliance Application and clicking “View: Accreditation Report” in the left navigation pane. A version of this report is also automatically saved in the Document Library when the accreditation process is complete.
Accessing the Accreditation Report in the legacy FACTWeb Portal
Not all programs have completed the accreditation process in the current online portal. For these programs, contact your FACT Accreditation Coordinator, who will be happy to email you a copy of the report.
The new Accreditation Portal launched in October 2018, and the number of applications in the new portal are increasing steadily. Prepare for your upcoming application or inspection by reviewing training materials available on demand. To aid in the transition between portals FACT has developed a Portal Resource Center filled with feature-specific How-To Guides and Training Videos. All training materials have been divided by audience. If you are looking for generic guides, proceed into the Applicant Area. If you are looking for inspector specific feature guides, proceed into the Inspector Area.
Training Videos Now Available On Demand:
Each session is 45 min in length and is free of charge.
- How-To: Complete an Annual, Renewal, or Eligibility Application in the Portal (for applicants)
- How-To: Complete a Compliance Application in the Portal (for applicants)
- How-To: Perform an Inspection in the Portal (for inspectors)
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 firstname.lastname@example.org, contact your FACT coordinator to confirm the email address on file.
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.
For questions related to your application, contact your organization’s assigned FACT coordinator or email FACT at email@example.com.
For technical assistance in the portal(s), contact FACT at firstname.lastname@example.org
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
To access an existing application in the legacy FACTWeb portal, navigate to https://www.factweb.org.
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
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
FACT Webinar: ISBT 128 Coding and Labeling
June 14, 2018
Full implementation of ISBT 128 labeling and coding is required by the seventh edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards, which becomes effective this month. On Thursday, June 14, 2018, at 11:00 am ET, Dr. Phyllis I. Warkentin will discuss common questions about ISBT 128 terminology, product codes, FACT Standards, and regulatory requirements. Webinar participants will have a chance to ask Dr. Warkentin questions at the end of the presentation.
WMDA-NetCord & FACT Cord Blood Day
September 14, 2018
Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the inaugural WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 14, 2018, in conjunction with the Cord Blood Connect international congress.
The WMDA-NetCord & FACT Cord Blood Day will highlight issues that affect cord blood banks’ abilities to optimize processes within a challenging environment. The evolving demand for umbilical and cord blood products requires banks to consider changing indications and financial limitations on a continuous basis. Accreditation encourages implementation of efficient, quality-driven processes to meet these demands while banking products suitable for clinical administration.
Morning presentation topics include global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. The afternoon has two breakout sessions including a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Register by August 31 and save $135! Registration fees are waived for FACT active and trainee inspectors.
Completing an Annual/Renewal Report in the Portal
Applicant Training Session
Join FACT’s IT Business Analyst for training on completing an annual or renewal report in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.
Completing a Compliance Application in the Portal
Applicant Training Session
Join FACT’s IT Business Analyst for training on completing a compliance application in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.
Performing an Inspection in the Portal
Inspector Training Session
Join FACT’s IT Business Analyst for training on performing an inspection in the new FACT Accreditation Portal. Alisa Forsythe will discuss the inspector specific navigation and features within the portal as well as the process for reviewing the applicant data, entering inspection findings, reviewing the inspection report, and submission. Webinar participants will have a chance to ask questions at the end of the presentation.