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 (firstname.lastname@example.org). 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.