Just the FACTs 2021 Volume 4
A hallmark of a strong quality culture is the concept of continuous quality improvement. At FACT, we embrace that spirit and are always open to opportunities to improve our Standards, our inspection and accreditation processes, and the cellular therapy field as a whole. There are many examples of these types of activities within this newsletter.
We extend our sincerest appreciation to our volunteer Standards Committee members, volunteer inspectors, and accredited organizations for their tireless efforts this year. Two months ago, we published the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards. It is always a labor of love. This edition was obviously no exception given the chaos of the past year; however, the committee did not deter from its work to revise and update our Standards. Both inspectors and accredited organizations alike explored the unknowns of virtual inspections. Not only have these inspections gone well, but we have implemented process improvements that have been discovered via the virtual inspection process.
Finally, please identify ways in which you can participate in the many efforts to harmonize industry requirements. You have the direct experience and expertise to leverage decades of lessons learned and accomplishments so that newer cellular therapies can experience the same growth and success as transplant. One such example, applying to be part of the standards working group on industry requirements for apheresis collection, is due by the end of this week.
Sincerely,
Catherine Bollard, MD
FACT President
Apheresis Collection Professionals Needed to Assist Industry with Drafting Collection Requirements
FACT participates in several working groups of the Standards Coordinating Body (SCB), including the Cell Collection Standards for Cell and Gene Therapies group. The SCB website introduces this group as follows: “Because other advanced fields with similar biological products (e.g., bone marrow and apheresis) have established collection best practices, the regenerative medicine community is eager to leverage those practices to create an international collection process standard that will help ensure the consistency of the critical quality attributes of cells collected for regenerative medicine products.”
With interest and participation from industry and the United States Food and Drug Administration (FDA), the efforts of this group may impact FACT-accredited Apheresis Collection Facilities and we strongly encourage participation of apheresis professionals given their direct experience and expertise in cell collection.
Through the work of this group, SCB has successfully obtained agreement from the Parenteral Drug Association (PDA) to draft standards on cell collection. Although industry is the intended audience for these standards, requirements may be promulgated through the requirements that clinical trial sponsors and commercial manufacturers expect of apheresis collection sites in their networks.
The PDA is recruiting volunteers to draft the requirements, currently referred to as “Apheresis Collection for Cell and Gene Therapy Products,” until July 16, 2021. “The goal is to create a standard document outlining recommendations for product manufacturer/sponsor requirements for apheresis cell collection. It will also create a standardized template for the leukapheresis manuals/SOPs written by product manufacturers/sponsors for the apheresis centers. This combined effort will work to reduce the burden upon the collection centers and in doing so, reduce errors.”
FACT encourages participation from accredited Apheresis Collection Facilities. According to the PDA, volunteers must have some subject matter expertise, and be willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.
Apply to the PDA technical team for this standard by July 16, 2021!
To Our Colleagues in Industry:
The SCB is asking industry groups and manufacturers to share their apheresis collection requirements and guidance to help with the creation of the new Parenteral Drug Association (PDA) standard effort, PDA 08-202x: Apheresis Collection for Cell and Gene Therapy Products.
For this effort to be successful, the PDA working group will need a clear view of what industry groups and manufacturers currently require, so that it can fit the standard as close to common industry practices as possible. To gain that insight, please fill out this short survey. The data collected will only be viewed/used in aggregate and will not be used outside of the standards effort. Please fill out this survey at your earliest convenience.
Apheresis Collection Professionals Needed as FACT Inspectors
FACT encourages all apheresis collection professionals to apply to become FACT inspectors! Join one of the most prestigious groups of international experts promoting quality cellular therapy for the benefit of patients.
This past year has brought renewed attention to the valuable contributions of the apheresis collection profession to provide lifesaving transplants, bring new cellular therapies to patients, and even address a global pandemic.
Please join the FACT inspectorate to continue to advance the quality of apheresis collection. In addition to maintaining a peer-to-peer approach to inspections, the following are benefits of becoming a FACT inspector:
- Learning new practices and techniques from other organizations.
- Improving the quality of your own organization.
- Networking with peers for ideas, questions, and collaboration.
- Sharing knowledge and expertise with others and giving back to the field.
- Discovering a variety of ways to meet FACT Standards.
- Developing professional skills and accomplishments.
- Traveling domestically and internationally.
- Accessing FACT educational sessions free of charge.
- Taking advantage of opportunities to serve on FACT committees.
One of our best sources of new inspectors is through nominations! If you know of someone who would make an excellent FACT apheresis collection inspector, please encourage that individual to apply or provide the name and contact information to FACT for further follow up.
Apply to become an inspector online
FDA Conference on Regulatory Education for Industry is Next Week
The United States Food and Drug Administration (FDA) is hosting its annual conference, Regulatory Education for Industry (REdI), virtually next week from July 19-23. Register for this free conference to learn directly from senior leadership at FDA. Continuing education credits for several professional organizations are available, and this conference can also be used toward GxP training now required by the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards.
For the first time, this conference will have tracks for three medical products: drugs, devices, and biologics. The biologics track will focus on different aspects of product development of advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER). Topics include regulation of tissue products under 21 CFR part 1271; development and regulation of cellular, gene, and plasma-derived therapies, and expedited programs for advanced therapies.
Register for the free, virtual FDA REdI Conference
FACT and JACIE Remained Committed to Publishing the Eighth Edition Hematopoietic Cellular Therapy Standards Despite Worldwide Pandemic
As an international Standards Committee, the FACT-JACIE Hematopoietic Cellular Therapy (HCT) Standards Committee is accustomed to remote collaboration. Its ability to work primarily online was brought to the test during the COVID-19 pandemic in 2020, and the committee rose to the challenge! The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021.
“Even with the challenges of a pandemic combined with very rapid advances in the field, amiable dedicated colleagues allowed successful completion of the task,” says Dr. Paul Eldridge, Chair of the Standards Committee. “I want to express my thanks and gratitude to everyone.”
Dr. Kim Orchard, Co-Chair of the Clinical Standards Subcommittee, adds, “The preparations for the eighth edition of the Standards proceeded with only minimal delays due to the COVID-19 pandemic. Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
“It was a challenge to continue with everything during the pandemic,” according to Dr. Nina Worel, Co-Chair of the Collection Standards Subcommittee. “Not so much with the FACT-JACIE team working on the eighth edition as the time schedule is perfect. We are used to working remotely and the meetings always close on time, but this time there were a lot of other additional meetings that were remote.”
“We managed to have the second face-to-face meeting of the combined FACT and JACIE teams just before the full impact of the first wave occurred, and all subsequent meetings were held by remote means which were already planned,” says Dr. Orchard. “Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The HCT Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and immune effector cell (IEC) requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards.
Following months of initial reviews and revisions, the HCT Standards Committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period. Additionally, other experts from FACT and JACIE participated in discussions related to new developments in the field, including Dr. John Snowden, member of the JACIE Committee and secretary of the European Society for Blood and Marrow Transplantation (EBMT), the FACT Immune Effector Cell Task Force, and others. These experts provided the HCT Standards Committee advice to consider when finalizing the Standards, with revisions ultimately drafted by the Standards Committee and approval granted by the FACT and EBMT Boards of Directors.
“It was really exhausting [with the other remote meetings]. However, we managed to finalize a great new edition of Standards for best quality in cellular therapy for our patients,” says Dr. Worel.
“It was a pleasure to work with committee members on the new edition of standards,” says Dr. Eldridge. “The opportunity to learn from such a diverse group of international experts is amazing.”
The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.
Review the Summary of Changes for the eighth edition FACT-JACIE Standards
Download the eighth edition FACT-JACIE Standards for free
Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free
Purchase printed copies of the eighth edition FACT-JACIE Standards
Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual
Download additional supporting documents
The X Factor: What is GxP and What Training is Required?
The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C4.4.2.5, and D4.4.2.5).
What is GxP?
The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”
Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).
What GxPs require annual training per the Standards?
FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.
All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).
How much training is required each year?
Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.
Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual
Enhancements to FACT’s Listing of Independently Accredited Collection Facilities
Accredited organizations are listed on the FACT website at http://www.factwebsite.org/. The listing of independently accredited Collection Facilities now specifies collection site locations included in their FACT accreditation. The addition of the specific collection sites included in the accreditation will assure organizations seeking collection facilities that the location has been inspected and meets FACT Standards.
Collection Facilities may be accredited as part of a single transplant program (i.e. in relation to one Clinical Program) or independently of a program. When a facility is accredited under the umbrella of a single program(s), whether it is integrally part of the same institution or a contracted external facility, it must be inspected with each program it serves. The term “independent” indicates that the facility has been accredited to operate in relation to multiple programs, rather than in relation to one specific program.
The website of FACT-accredited organizations offers a variety of search functions, such as “Search by Name”, “Search by Cell Therapy or Cord Blood”, and “Search by Collection Type”. To search for an independently accredited Collection Facility, use the “Search by Service Providers” function. Drop-down options under this function include:
- All Service Providers.
- Cellular Therapy Processing Provider.
- Marrow Collection Provider.
- Peripheral Blood Collection Provider.
View the list of FACT-Accredited organizations on the FACT website
Virtual Inspections Lead to Accreditation Process Improvements
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:
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- 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.
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
ASFA Publishes 2021 Reimbursement Guide
The American Society for Apheresis (ASFA) Reimbursement Guide helps apheresis collection facilities communicate with billing staff about the use of billing codes and how insurance billing and payment works in different treatment settings for the types of apheresis procedures performed.
Of particular interest to FACT-accredited Apheresis Collection Facilities, this guide includes focus sections on extracorporeal photopheresis (ECP) and blood-derived stem cell harvesting.
Download the 2021 ASFA Reimbursement Guide
Join the American Society for Apheresis
Celebrate World Marrow Donor Day on September 18, 2021
World Marrow Donor Day (WMDD) is a global celebration of donors that takes place on the third Saturday of September, or September 18th in 2021. Donors will be celebrated on all continents of the world through both social and conventional media.
The World Marrow Donor Association (WMDA), which believes that all patients deserve a chance to receive a stem cell transplant, founded WMDD in 2014 to thank blood stem cell donors and to raise awareness about the importance of registering as a potential donor.
How will you celebrate WMDD? Whether a short message or a big event, the WMDA encourages you to be creative and find a way to acknowledge donors on September 18th. Looking for ideas? Enjoy browsing through the 2020 events for inspiration!
A 24-hour livestream on September 18th will share WMDD events for all to see! Submit your event by July 23rd for consideration.
In the meantime, take a moment to read uplifting stories about donors that are posted on the WMDD website. FACT thanks all blood stem cell donors for their lifesaving gifts!
Navigating the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards Webinar
The eighth edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards was published on May 17, 2021 and will be effective on August 16, 2021. To support FACT accredited and applied programs during this transition, FACT is offering a webinar, titled Navigate the Eighth Edition Cellular Therapy Standards, on July 21, 2021 at 10 am CT, 3 pm GMT. Dr. Paul Eldridge from Levine Cancer Institute, the Standards Committee Chair, will explain changes including:
- Genetically-modified cellular therapy products
- Training in GxP
- Quality management
- Informed consent
- Labeling
- Storage
Register for the FACT-JACIE and WBMT Webinar: Quality and Accreditation for Cellular Therapy: A Global Perspective
FACT Cord Blood Educational Events Announced
Join FACT for a cord blood inspection and accreditation workshop and quality boot camp on Wednesday, September 29, 2021, from 7:00 am – 4:00 pm CT, 12:00 – 21:00 GMT. The FACT workshop morning sessions will begin with an overview of FACT accreditation, detailing the accreditation process from application to accreditation. Sessions continue with a guided tour of a cord blood bank in which the presenter will review requirements in the FACT Cord Blood Banking Standards that can be identified and evaluated during the tour (on-site or virtual). Next, presenters will discuss common citations in cord blood banking and how to avoid them. Examples will be provided, and case studies presented. Finally, the morning workshop will end with short presentations from cord blood banks with different organizational models including public, private, and hybrid, who will discuss maintaining operations and compliance through various cord blood banking challenges. Afterwards, participants can ask questions to an expert panel.
The afternoon quality boot camp sessions begin with a presentation on developing a Quality Management Plan and assessing its effectiveness. The presentation will be followed by a question and answer session and an interactive break-out session. The second half of the afternoon will focus on stability studies in cord blood banking and includes a presentation on the results of the AABB/ISCT stability studies survey, presentations on establishing and maintaining a stability program within a public or private cord blood bank, and ends with a panel discussion.
During lunch, attend an optional featured session! Listen to FACT’s new president, Dr. Catherine Bollard, reflect on the accomplishments and the future of FACT.
Register now for early bird pricing!
FACT workshop and quality boot camp hosts:
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| Roger Horton, PhD Cord Blood Bank Director The Anthony Nolan Cord Blood Bank |
Diane Fournier, PhD Laboratory Head and Scientific Director Héma-Québec Cord Blood Bank |
