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 firstname.lastname@example.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.
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.
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.
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.
On March 31, 2021, the International Society for Cellular Therapy (ISCT) will host a webinar titled, Apheresis Product Procurement. The webinar will include the experiences of a collection facility shifting from a service delivery mindset to one considering manufacturing in a regulated environment as manufacturing and clinical care documentation now begin with donor selection, qualification, and collection with more licensed products.
It is official! The final ISBT 128 Labeling of Collection Products for Cellular Therapy Manufacturing Standard is published.
Following multistakeholder efforts to standardize labels for cells collected for further manufacturing, and two rounds of public input, ICCBBA has finalized this ISBT 128 labeling Standard. The Standard is for use only in situations where the sponsor or manufacturer has adopted it.
This Standard may reduce the variations in labeling requirements for apheresis collections for different sponsors or manufacturers, minimizing the risk of errors and increasing patient safety. ISBT 128 is a well-established and international coding and labeling system. Standardizing labeling requirements using this system enhances cellular therapy product traceability and reduces the number of systems that must be adopted, implemented, validated, and maintained at health care institutions.
FACT-accredited apheresis collection facilities are encouraged to review this Standard, work with their ISBT 128 vendors regarding implementation and validation, and inquire with clinical trial sponsors and manufacturers about their intentions for adopting it.
As reported in a previous newsletter article, the first FACT Inspection & Accreditation Virtual Workshop on September 21, 2020 was well received by those in attendance, and we are pleased to provide everyone with an opportunity to view the recording of the workshop.
The workshop began with an overview of the FACT accreditation process and continued with hands-on activities to guide the applicant through the accreditation process. Workshop objectives include:
- Describe the accreditation process.
- Evaluate documentation to ensure compliance.
- Organize the on-site inspection process.
- Plan a program tour.
- Identify strategies to support a successful inspection.
- Practice evaluating deficiencies.
A digital download of the workshop recording can be purchased from the FACT online store at competitive prices. As always, inspectors and inspector trainees may download the recording for free!
Purchase the virtual workshop recording
On September 15, 2020, the American Society for Apheresis (ASFA) celebrated Apheresis Awareness Day. The purpose for this observance is to raise awareness of apheresis medicine, including apheresis practitioners and the donors and patients they save every day using evidence-based practice.
The awareness day included an official hashtag (#ApheresisDay2020), online games including Jeopardy and Apheresis Word Scramble, and a Question of the Day.
We at FACT extend our heartfelt appreciation to apheresis professionals around the world, including physicians, nurses, technicians, scientists, quality managers, and more who work as an important team performing life-saving work every day. We acknowledge the extensive role they play both in providing standard of care therapy and cutting edge research. Apheresis professionals are in high demand because the work they do is so important. Thank you for all that you do!
Comments Requested on Standard Labeling Proposed for Apheresis Collection Products: Due April 24, 2020
FACT is pleased to announce that ICCBBA, administrator of the ISBT 128 coding and labeling standard, has released a draft document and label for public review and comment. The document, “Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing,” and the described label applies to collected cells, commonly referred to as “starting material,” intended for further manufacturing in support of clinical cellular therapy trials and commercial cell products. This draft is a result of a multi-stakeholder effort to standardize labeling requirements of apheresis collection facilities, including the Standards Coordinating Body, the Deloitte NextGen Industry Working Group, FACT, and many others.
Variations in sponsors’ labeling requirements have been a notable challenge for apheresis facilities in recent years and introduce risks of errors and misinterpretation of patient data. The use of an ISBT 128-compliant label will reduce manual transcription errors and promote chain of identity, including for autologous cells. Furthermore, the use of ISBT 128 for these collections will allow the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities for clinical application.
The next step of this important standardization effort is to solicit input from the entire community. Please review this document and provide comments by April 24, 2020 to Dawn Henke of the Standards Coordinating Body (email@example.com). Equally important, please distribute this announcement to your industry, hospital, vendor, and professional colleagues to make them aware of this opportunity and encourage them to review the document and submit feedback.
The recently published book, Best Practices of Apheresis in Hematopoietic Cell Transplantation (Abutalib et. al., 2020), includes a large number of topics relating to the use and performance of apheresis in hematopoietic cell transplantation. The book is described as a practical resource for clinicians ranging from residents to faculty members and other healthcare personnel. The book is available for purchase in its entirety or by individual chapters.
FACT President Dennis Gastineau, MD wrote Chapter Three, FACT-JACIE Standards: Common Citations and How Best to Avoid Them. The chapter on citations focuses on deficiencies found in apheresis facilities during on-site FACT inspections. Dr. Gastineau briefly describes the citations and then suggests methods for avoiding them in future inspections.
Abutalib, S.A., Padmanabhan, A., Pham, H.P., Worel, N. (Eds.) (2020). Best Practices of Apheresis in Hematopoietic Cell Transplantation. Springer International Publishing. doi: 10.1007/978-3-319-55131-9.
Variability in Cell Collection for IEC Products Discussed with FDA during 2019 Cell Therapy Liaison Meeting
The Food and Drug Administration Cell Therapy Liaison Meeting (FDA CTLM) took place on March 5, 2019 and a summary of the meeting is now online. This meeting was made possible by 13 organizations serving the planning committee, led by Olive Sturtevant and the ISCT North America Legal and Regulatory Affairs Committee. Ms. Sturtevant is also a member of the FACT-JACIE Standards Steering Committee.
Four topics were presented to the FDA, including regulation of biobanking material for future products, collection of mononuclear cells (MNCs) for immune effector cell (IEC) products, minimum characterization criteria for clinical grade induced pluripotent stem cell (iPSC) products, and early interaction mechanisms for tool/device developers.
The presentation and discussion regarding the collection of MNCs for IEC products is particularly timely for many FACT-accredited apheresis facilities. The summary outlines the challenges Dr. Jay Raval presented on behalf of the American Society of Apheresis (ASFA) and the discussion with the FDA afterwards.
This summary may be useful to discussions between apheresis facilities and the commercial manufacturers they work with. It also provides ideas that the field could pursue to reduce variability to a meaningful level that will ensure quality IEC products without limiting the ability of experienced apheresis facilities to care for their patients.
This meeting is just one event regarding this issue in which FACT participated. We will continue to provide updates via the Just the FACTs newsletter as appropriate. In the meantime, we have appreciated the spirit of collaboration that has been demonstrated by commercial manufacturers, healthcare providers, related organizations, and many others.
The hematopoietic progenitor cell (HPC), Apheresis and HPC, Marrow Donor History Questionnaire (DHQ) materials were developed by the AABB Interorganizational Uniform Donor History – HPC Task Force to provide establishments with a standardized tool to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, the Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program (NMDP).
HPC, Apheresis and HPC, Marrow DHQ Version 2.0, June 2019
The HPC, Apheresis and HPC, Marrow Donor History Questionnaire materials have been updated to version 2.0. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.9.
The HPC, Cord Blood DHQ materials were developed by an AABB interorganizational Uniform Donor History – HPC task force to provide establishments with a standardized tool to screen allogeneic as well as related cord blood (HPC, Cord Blood) donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program. Allogeneic donors are usually collected at public cord blood banks for use by the general public. Private cord blood banks generally collect related donors for either allogeneic use in a first or second degree relative, or for autologous use. Allogeneic and related cord blood donors are screened for the same risk factors; however, the regulations for using related units allow much more flexibility for distributing the cord blood units for transplantation.
HPC, Cord Blood DHQ Version 1.7, June 2019
The HPC, Cord Donor History Questionnaire materials have been updated to version 1.7. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.6.
The Special Issue Writing Committee of the American Society for Apheresis (ASFA) updated indications for evidence-based use of therapeutic apheresis (TA). The Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue contains fact sheets summarizing the evidence for the use of TA for 84 relevant diseases and medical conditions.
Fact sheets related to blood and marrow transplantation included in these guidelines include graft-versus-host disease (GVHD), ABO-incompatible hematopoietic stem cell transplantation, and HLA-desensitized hematopoietic stem cell transplantation. Given the wide range of TA performed by apheresis facilities, review of all fact sheets is worthwhile.
Padmanabhan, A, Connelly‐Smith, L, Aqui, N, et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence‐Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue. J Clin Apher. 2019; 34: 171– 354. https://doi.org/10.1002/jca.21705
By Sarah Litel-Smith, FACT Accreditation Coordinator
We have noticed an uptick in the number of questions regarding storage in the collection facility. There appears to be a misconception that collection facilities do not store products if the processing facility or a courier picks up the product. However, a product is considered to be in storage when it is not under the immediate control of qualified personnel. For example, a product placed in a transport container waiting to be picked up, even for a short time, is considered to be in storage.
All apheresis collection facilities must have policies or procedures that, regardless of the amount of time the product is stored, address cellular therapy product storage and define every step of the product from the time of collection to the time of release to the courier or processing personnel.
Policies and procedures must address the following in relation to storage:
- Defined storage areas and container,
- How the integrity and potency of the cellular therapy products are maintained,
- The security of the facility,
- Facility control of temperature and humidity for storage overnight or longer,
- Storage duration, and actions to take if conditions are not met,
- Product expiration date and time,
- Mechanisms to prevent product release until release criteria are met, and
- Transport or shipping temperature range and duration.
The American Society for Apheresis (ASFA), in collaboration with the American Society for Clinical Pathology (ASCP), now offers a new credential in apheresis medicine.
The Qualification in Apheresis (QIA) is offered through ASCP and follows the Hemapheresis Practitioner (HP) and Apheresis Technician (AT) certifications. QIA certification expands credentialing for apheresis medicine professionals. There are specific eligibility routes that must be satisfied, including an eligibility route for international professionals.
The 50-question exam covers six areas: Basic Science; Clinical Applications; Donor/Patient Care; Instrumentation; Operational Considerations; and Standards, Guidelines, and Regulations. The qualification is valid for three years, and requalification requires participation in continuing education.
For more information on eligibility routes and available resources, visit the Qualification in Apheresis (QIA) page on the ASFA website.