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.
Virtual inspections are currently being scheduled for those programs whose renewal accreditation process was interrupted in March 2020 due to pandemic-related issues. FACT Accreditation Coordinators have communicated information about the process to the Program Directors, Quality Managers, and the primary contact persons at those Cellular Therapy Programs whose inspections were canceled and those that were being scheduled. The FACT Business Manager Is currently contacting these Programs for potential inspection dates with the goal of completing the renewal process prior to the expiration date of the current accreditation for each Program.
FACT has created a Virtual Inspection Resource page on the FACT website at: http://www.factwebsite.org/virtualinspections/. Numerous documents have been updated and are available there, including guidelines for applicants and inspectors, technology guides, and examples of timelines and agendas. By popular request, a new OneNote template to organize compliance documentation has been developed for the 7th Edition FACT-JACIE Hematopoietic Standards for Cellular Therapy. Additional resources will be added to this page as they become available.
Following two successful pilot virtual inspections, participating program personnel, volunteer inspectors, and FACT staff identified several best practices for a virtual inspection and issues for process improvement. Several topics were identified as key to the success of the virtual inspection process. Best practices include:
- Organization is key. Using OneNote to organize documents was an extremely helpful tool for both program personnel and inspectors. In OneNote, SOPs, policies, and other supporting documents and examples are linked directly to the specific FACT Standard and checklist question, making demonstration of compliance efficient and clear. FACT has created a OneNote template containing the 7th Edition FACT-JACIE Hematopoietic Cellular Therapy Standards that is now available on the Virtual Inspection Resources page.
- The pilot inspection teams identified several additional documents that would have been very helpful to review in advance of the inspection. While FACT had not planned to require additional submitted documents, this recommendation is an important process improvement to be implemented immediately. Additional documents should be submitted in the FACT Portal via the Virtual Inspection Documents tab of the Document Library, identified by the relevant Standard number at the beginning of the document title. New documents include:
- Any policy or SOP specifically referenced in the Quality Management Plan.
- The most recent Annual Report on the Effectiveness of the Quality Management Program. A list of documents has been added to the Applicant Guidelines in the Virtual Inspection Resource Center.
- Be prepared to demonstrate tracking and tracing of products and processes from donor identification through product collection, processing, storage, and administration.
- It is recommended that each person participate in the inspection at a separate computer to facilitate efficient responses. Having the applicant team together in one conference room is suitable if all attendees are able to see and hear sufficiently; however, it is easiest if participants are in separate rooms or adequately socially distanced to avoid the need for masks that tend to inhibit communication.
- If more than one area (for example, both the adult and pediatric clinical programs, or clinical, apheresis, cell processing) uses the same Quality Management Plan, the applicant program should consider jointly reviewing the Quality Management section with all relevant inspectors. This should be included in the agenda when it is created and shared with the inspection team prior to the inspection.
FACT is pleased that the pilot virtual inspections were successful and the lessons learned can be applied to ongoing renewal inspections. For initial applicants, or programs with a new service or space being added, an on-site inspection will be required. FACT continues to monitor inspector availability for travel and will schedule in-person inspections when applicants are prepared and inspectors are available. Virtual inspections for cord blood banks will begin later this spring.
Inspector availability and willingness to participate in the virtual inspection process is critical to FACT’s continued success as the premiere accreditation in cellular therapy. We need and encourage you to participate!
Careful attention has been given to development and implementation of the virtual reaccreditation process from both the applicant and inspector point of view, including training opportunities and written guidelines. All current active inspectors are eligible to perform virtual inspections. Training for inspectors will begin within the next few weeks starting with those inspectors who have agreed to a scheduled inspection. Virtual inspection training for current inspectors will be all virtual and consist of two steps. Step one includes viewing a short introductory webinar covering the basics of the virtual inspection process and technology, and reviewing the inspector-related documents in the FACT Virtual Inspection Resource Center, located at: http://www.factwebsite.org/virtualinspections/.
The second step will include small group interactive training with the Accreditation Services Manager, Suzanne Birnley, to demonstrate and practice using Zoom as a platform and to ensure inspectors understand the full functionality available to them. FACT’s Business Manager Jay Ann Witt, is currently scheduling virtual renewal inspections and will be contacting active inspectors for availability.
Feedback from both inspection teams after two pilot virtual inspections in January was very positive. The inspectors felt that the preparation process was similar to preparation for an in-person inspection. Slightly more time was required to review additional documents the inspectors requested utilizing RFIs in the FACT Accreditation Portal. On the inspection days, it was beneficial for the inspector to have a printed copy of the checklist or to use two computer screens to enable the checklist or a document to be open on one screen while the Zoom meeting was open on the other. FACT is currently scheduling virtual inspections for two days. Program size and complexity contribute to the amount of time needed, however, allowing two days relieves some pressure and if finished early, allows the inspection team flexibility to plan for the closing meeting and begin report preparation.
We are excited to get this new program established and look forward to participation from all our inspectorate. Additional information and training schedules will be provided soon via email.
Interested in becoming a FACT Inspector? Visit http://www.factwebsite.org/BecomeInspector/.
FACT has initiated its accreditation renewal process with virtual inspections starting with two programs whose renewal inspections were delayed in March 2020 due to the COVID-19 pandemic. By all accounts, the virtual inspections were successful! The applicant programs were well prepared, the processes were generally effective, inspectors were able to verify compliance with Standards, and both inspectors and program staff continued to learn throughout the process. As a result, FACT is now scheduling virtual inspections for additional programs whose inspections were delayed, followed by those who were in the process of scheduling inspections when the pandemic started. Program Directors, Quality Managers, and primary contact persons at eligible programs should expect direct communications from their FACT Accreditation Coordinators to begin this scheduling.
The FACT Virtual Inspection Task Force developed this virtual process over the past several months to closely mimic the in-person experience to the extent possible, including submission of the same documents to the FACT Accreditation Portal in advance and review of these documents by the Inspection Team. The FACT Accreditation staff participated in training the applicants and inspectors in the technical skills required for the virtual process. Members of the Task Force volunteered their own programs to serve as pilot programs for the virtual inspection process, and volunteered themselves to be the first inspectors. The two pilot programs included clinical transplant and immune effector cellular therapy sites, bone marrow and apheresis collection services, and cellular therapy product processing facilities with minimal and more than minimal manipulation processing. Each pilot inspection took place over two days using individual secure Zoom calls, during which the inspectors were able to view documents and pre-recorded facility video tours and interview various members of the applicant program (including nurses; advanced practice professionals; pharmacists; ICU, ER, and Radiation Oncology staff; data managers; and clinical research associates. Program staff shared records, minutes, policies, SOPs, and other documentation by sharing a computer screen for electronic or scanned documents or by using a cell phone or document camera for other types of documentation such as paper files, logs, and records.
Task Force members and FACT staff observed portions of these pilot inspections and are currently assessing the processes. At least two important themes have been identified to date. First, it is important for the applicant program to be well organized with documentation prepared in the order of the FACT Standards. Use of Microsoft OneNote or other electronic programs to link program documentation to a specific FACT Standard is very helpful to allow efficient location and display of relevant policies and SOPs. Once created, this tool can be used to continuously update documentation and maintain inspection-readiness through the accreditation cycle. Second, the inspection goal is to demonstrate implementation of required policies and SOPs through examples. Identification and organization of these patient records, meeting minutes, validation studies, audit reports, and other quality documents according to the specific standard facilitates demonstration of compliance. While neither of these concepts is new, the virtual process magnifies the importance of careful organization.
Additional details of the inspection process are available on the FACT Virtual Inspection Resource Center at: http://www.factwebsite.org/virtualinspections/. Numerous documents are available, including timelines, sample inspection agendas, applicant and inspector guidelines for the virtual process, organization tips, and technical information related to Zoom and document sharing methodologies.
As the next group of programs is ready for inspection, additional training will be held for currently active cellular therapy program inspectors. A full inspector training course for new inspectors that will include both the in-person and virtual inspection processes is planned for early summer. This virtual inspection process is intended for renewal applications only. Initial accreditation visits will be in person and will be scheduled when it is safe to do so and appropriate inspectors are available to travel. Virtual inspections for cord blood banks will begin this spring. New applicants for initial accreditation will require an in-person inspection that will be scheduled and fulfilled as appropriate inspectors are available.
FACT is grateful for the extra effort on the part of these pilot programs and inspectors. The Virtual Inspection Task Force includes members of the Cellular Therapy Accreditation Committee, the Inspector Development Committee, and the Board of Directors.