Momentous things are happening! First, go vote if you are a US citizen, and, second, we are well into the process of initiating virtual inspections. Sharpen your voting pencils and also your quality pencils (oh, quality people don’t like pencils, so fill your ink pens) and polish off final preparations for inspections.
The process and exceptions are outlined in this newsletter. Read carefully, accredited programs and first-time applicants. We will be starting soon with a secure online process. We know this will be a lot of work for some people, and others may already have electronic systems that will facilitate the process. I know that the inspectors and programs alike will execute this as thoroughly as the in-person inspections.
Speaking of virtual meetings, our first-ever virtual applicant training meeting in September was very successful with over 160 participants from around the world and across attendant time zones. It was really a 24-hour meeting, and the questions were frequent and good—we kept the speakers busy.
It’s great to get started again, and while infections are unfortunately soaring, I think we have a way to handle this part of business again. In the meantime, wear masks at home and at work and keep each other as safe as possible.
FACT plans to begin virtual inspections this fall. There are many details to be finalized, however, the FACT Board of Directors has approved the plans outlined below. Thank you in advance for your flexibility and patience as we undertake this new process to protect the safety of our volunteer inspectors, personnel at accredited programs, and patients.
Eligibility for Virtual Inspections
Situations eligible for a virtual inspection include:
- Renewal accreditation inspections of clinical, apheresis, or cell processing programs applying independently or together as a hematopoietic cell transplantation program, including immune effector cells.
- Add-on service involving an existing accredited program (such as immune effector cells [IECs] or more than minimal manipulation processing).
- Reinspection of all or a portion of a program following Accreditation Committee review of an in-person inspection, provided at least one member of the original inspection team participates in the virtual inspection, and there were no citations related to the physical integrity of the location itself.
Situations not currently eligible for a virtual inspection, and for which an on-site inspection is required, include:
- Initial accreditation
- Addition of an entirely new service in a new space, such as a pediatric program at a Children’s Hospital being added to an existing accredited adult program in another facility or a new current Good Manufacturing Practices (cGMP)-compliant processing facility added to an accredited transplant program.
In general, inspections will be either virtual or on-site, not a mixture. There may be exceptions. For example, an add-on to an existing program that is in the renewal process could have a virtual inspection for the renewal portion and an on-site visit of only the add-on portion (e.g., a cGMP facility for IECs added onto an accredited transplant program).
FACT is also working toward resuming some prioritized on-site inspections where these can be done in compliance with state, local, and CDC guidance and within facility and inspector restrictions. This applies primarily to new applicants.
Prioritization of Virtual Inspections
Priority for virtual inspections will be given to cellular therapy programs whose on-site inspections were canceled, then to those who were in the process of scheduling when the on-site inspections were suspended in March 2020. Cord Blood Banks will begin virtual inspections slightly later.
All programs have been given an additional 6-month extension of their accreditation expiration dates as we resume inspections in this new way. This represents a total of a one year extension to the accreditation expiration.
Preparing for Virtual Inspections
Programs will receive direct individual communications regarding additional documentation that will be required either as an extra annual report or additional pre-inspection updates, depending on where they are in the accreditation cycle.
Please watch for communication from your FACT Accreditation Coordinator. You may contact your FACT Accreditation Coordinator for additional information and share this information with other appropriate individuals in your program, including apheresis and cell processing services. Your Accreditation Coordinator’s contact information can be found at http://www.factwebsite.org/About_FACT/FACT_Staff.aspx.
If you do not know who your coordinator is, contact Suzanne Birnley, Manager of Accreditation Services at firstname.lastname@example.org.
The Virtual Inspection Process
The platform for the interactive virtual inspections will be a FACT HIPAA-compliant ZOOM Healthcare account. There will be video tours expected, however, inspections will not be recorded. Video tours and additional documentation will be submitted through the FACT Accreditation Portal.
Cellular Therapy Program inspections will most likely occur over two days to allow both inspectors and program staff additional time to review and prepare additional documentation.
The Virtual Inspection Task Force is finalizing:
- The list of additional documents that will be submitted in advance.
- A list of documents that the program must be prepared to show to the inspector via ZOOM shared screen, which may include electronic documents such as SOPs, a portion of the EMR, or other scanned documents. Paper records may be shared via scanning or document or portable camera.
- A list of items that will be demonstrated via a video tour of each site.
- A proposed inspection agenda, including additional persons to be interviewed during the inspection, such as staff nurse, pharmacist, ICU / ER physician or staff.
Confidentiality of the Virtual Inspection
FACT has a Business Associate Agreement in place with each accredited and applicant program to cover confidentiality issues, including protected health information that may be viewed as part of the accreditation process, but is not recorded or retained by FACT or its volunteers. FACT’s legal counsel has determined that the current Business Associate Agreement is sufficient to safeguard the virtual inspection process. FACT will work with any institution individually if there are concerns. All FACT staff and volunteers annually sign Confidentiality and Conflict of Interest Agreements.
In addition, the virtual inspection process will incorporate practices to enhance confidentiality, such as requirement for a private room for the inspector to conduct the inspection and lack of recording of the inspection.
Frequently Asked Questions
In addition to questions directly related to accreditation, FACT continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is periodically updated and is available on the FACT website. Topics include:
- Rescheduled inspections
- Renewal process
- Allogeneic transplant numbers
- Relocating transplant patients
- Care adjustments related to COVID-19
If you have further questions or concerns, please contact Dr. Phyllis Warkentin [email@example.com or 402-559-6781], the FACT office (402-559-1950), or your FACT Accreditation Coordinator.
Other Resources Available:
The Standards Coordinating Body (SCB) is seeking input from the regenerative medicine community to update its report: Community Perspectives: Needed Standards in Regenerative Medicine. The content and potential impact of this report on the development of future standards may impact FACT stakeholders, and we encourage volunteer inspectors and personnel from accredited organizations to complete the survey. The survey will be available until November 6, 2020 at 12 pm Eastern Standard Time.
Per the SCB, this report, “is intended to align community efforts around the standards that could have the greatest benefit to the regenerative medicine field and improve the safety and quality of regenerative medicine products. Your input will ensure that the report reflects the current needs and perspectives of stakeholders in the community, helping to direct time and resources toward the highest-priority standards.”
FACT accreditation is a credential that has its greatest value in the peer-to-peer exchange of ideas to confirm and improve quality in patient care and laboratory services. Successful accreditation is awarded with two tangible items: an Accreditation Certificate and a final Accreditation Report. Although the certificate gets more prominence, often framed and mounted as a visual symbol of quality, the final report is a detailed accounting of what accredited programs implemented to reach compliance with all FACT Standards.
Each Accreditation Report provides important information related to an accredited program’s journey to initial or renewal accreditation. The final report includes:
- The name and location of the program
- The date of the on-site inspection
- The clinical, collection, processing, and/or banking sites and services associated with the accreditation
- Key personnel
- Identification of the FACT inspection team
- A description of the program
- Deficiencies and variances cited by the inspection team and approved by the Accreditation Committee
- Required responses to provide evidence of correction of each deficiency or acknowledgement of each variance
- The program’s responses documenting completion of corrective actions and compliance with Standards
- FACT’s response, or determination regarding the adequacy of the program’s corrective action
- Details of any additional follow up reports or documentation due to FACT
After completing the rigorous accreditation process, programs may debrief the contents of the Accreditation Report and then file it away, turning attention to its many other important duties until annual reporting is required. However, the final report is a valuable tool that can be used throughout the accreditation cycle.
Programs that have corrected deficiencies and submitted adequate evidence of correction and compliance with standards should be very proud of the work they have invested into improvement. Lessons learned throughout this process can be applied to the entire program. For example:
- How will we evaluate our corrective actions to confirm long-term effectiveness?
- What other strengths and weaknesses did we discover while correcting deficiencies?
- Are there further root cause analyses we should perform to prevent similar deficiencies?
- Can we apply the same process to evaluate other aspects of our program?
Ideas generated from this review of the Accreditation Report may be useful to maintaining the Quality Management program via audits, process development, personnel training, and other quality concepts.
External Confirmation of Quality
Apheresis collection facilities, cell processing facilities, and clinical services are each important in the context of blood and marrow transplantation, where accreditation covers the entire scope of the therapy from patient selection and treatment, through product selection, collection, processing, and administration. These same services participate in clinical trials often including products developed and manufactured by industry partners. These facilities recognize the importance of standards, have achieved voluntary FACT accreditation, and have played a major role in delivering new products to patients. They have used their quality programs and processes to quickly adapt to increasing numbers of products, procedures, and manufacturers. However, facilities have individually and collectively expressed concern regarding the growing number of on-site audits. The increased burden of preparing for, participating in, and responding to audits requires more resources to be diverted to these activities rather than toward patient care.
Commercial manufacturers who produce cellular therapy products for clinical trials or under an approved regulatory license may wish to leverage FACT accreditation to streamline audit activities, verify quality practices, and reduce the burden on health care entities. To do this, manufacturers may request a copy of the final FACT Accreditation Report. FACT does not provide Accreditation Reports to any entity except the accredited program. Accredited programs are not restricted from sharing these reports and may choose to provide them to manufacturers leveraging FACT accreditation, however, they are not required to do so.
Accredited programs or their hospital administration may be hesitant to disclose deficiencies cited during an on-site inspection. However, FACT accreditation is a voluntary, peer-based quality improvement process, during which some deficiencies can be expected at any program. The documented deficiencies demonstrate the rigor of the inspection process. The final report includes the description and documentation of the program’s corrective action, FACT’s determination of the adequacy of the response, and any additional follow up that may be indicated. Responses to deficiencies are an opportunity to proudly share a program’s process improvements. Programs should inquire of any commercial manufacturer regarding the confidentiality of information they provide to increase confidence in the use of the FACT report.
If a program chooses to provide the final Accreditation Report to a commercial manufacturer, it will likely be able to participate in an abbreviated site audit because the Accreditation Report can be used to confirm the quality systems in place meet FACT Standards. If a program chooses not to provide the report, it may be required to undergo a full site audit that will include requirements duplicative to the FACT Standards.
In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Monday, November 16, 2020 at 10:00 am ET, 15:00 GMT. The purpose of this webinar is to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is 90-minutes, complimentary, and will be presented in French. Slides will be available in both English and French.
- Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada)
- Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole “collection and transplantation of HSC” at the Agence de Biomédecine. (France)
FACT also encourages you to join the Save the Cord Foundation on November 17 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.
Instructions for joining the FACT Webinar on November 16:
- Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
- Meeting ID: 922 6984 5238
- Passcode: WCBD
En préparation de la Journée Mondiale du Sang de Cordon, FACT vous invite à participer à un webinaire spécial le lundi 16 Novembre 2020 à 10.00 ET, 15:00 GMT. L’objectif de ce webinaire est de discuter les progrès récents liés à l’utilisation de la méthode d’expansion de cellules UM171 en transplantation de sang de cordon, et également de comprendre l’effet de la pandémie COVID-19 sur la collecte et la transplantation de sang de cordon en France. Ce webinaire de 90 minutes est gratuit et sera présenté en français. Les orateurs seront:
- Maude Dumont-Lagacé, PhD, Spécialiste en Sciences Cliniques à ExCellThera Inc (Canada)
- Catherine Faucher, MD, Hématologue Clinicienne, actuellement en charge du pôle “Prélèvement et greffes de CSH” à l’Agence de biomédecine (France)
FACT vous encourage également à rejoindre la Fondation Save the Cord le 17 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations d’introduction pour le public et des présentations académiques par des chercheurs et médecins transplanteurs renommés, sur les dernières avancées et les traitements utilisant le sang de cordon.
Instructions pour rejoindre le webinaire le 16 Novembre:
- Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
- Identification de la conférence: 922 6984 5238
- Mot de passe: WCBD
FACT’s first Inspection & Accreditation Virtual Workshop, hosted on September 21, 2020, was a great success! FACT thanks the workshop chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH; the FACT Education Committee, the presenters, and the attendees for bringing energy and enthusiasm to this important educational event. A culture of quality is as important now as it ever was, and we enjoyed being “with” the FACT community again!
Please Complete the Workshop Evaluation
If you attended the workshop, please tell us everything! We are always striving to provide a great educational experience. As part of this, we would appreciate feedback on FACT’s first virtual workshop so we can improve and make the next virtual event even better.
The Foundation for the Accreditation of Cellular Therapy hosted its first virtual inspection and accreditation workshop on September 21, 2020. The workshop included two tracks, apheresis collection and cord blood banking. Attendance included 165 workshop registrants, 35 FACT staff members and Matrix Maxx staff members, and 19 workshop presenters and moderators. The breakdown of the 165 attendees is illustrated below:
Registrants from 18 different countries attended, including:
Lunch with Leaders
Participants were able to ask any question to FACT leaders during the Lunch with Leaders session.
Favorite Parts of the Day
In addition to these favorite parts of the day, attendees enjoyed feeling connected with the international FACT community during this challenging year and felt the workshop was one of the most interactive and engaging virtual conferences. Attendees also felt that the workshop was comprehensive and educational despite being virtual.
The workshop included pre-recorded presentations, live question and answer sessions, interactive activities requiring audience participation, and a live tour of an apheresis unit and cord blood bank.
Participants were able to ask questions at any time via the workshop chat feature. Each track included a moderator; Dr. Dennis Gastineau moderated the apheresis track and Dr. Kim Kasow moderated the cord blood track. Dr. Gastineau and Dr. Kasow were able to monitor presentation chat questions and interact with the presenters to ensure all questions were answered.
Participants joined in polling sessions, which allowed them to participate in analyzing case studies on both workshop tracks.