The FACT-JACIE Hematopoietic Cell Therapy Standards state, “If the intended recipient has received high-dose therapy, the cellular therapy product shall be transported.” (CM10.3.2, C10.3.2, D10.7) Some have asked what the purpose of this standard is because a product always needs to be distributed to the recipient.
The key word in this standard is “transported.” As stated by the FACT-JACIE definitions in Part A of the Standards, “transport” is the physical transfer of a cellular therapy product within or between facilities during which it does not leave the control of trained personnel at the transporting or receiving facility. In other words, someone who is trained to transfer a product must be with it at all times. This is in contrast to shipping, during which the product does leave the control of trained personnel (such as shipment on a commercial distributing company’s truck or airplane).
If a patient has undergone high-dose marrow ablative treatment in preparation for transplant, the cellular therapy product is essential for the patient’s survival since it may not be possible to obtain additional marrow or blood from the original donor or a second donor in time to prevent complications from aplasia. For this reason, it is important that the product be entrusted to a knowledgeable individual who accompanies it from the distributing facility to the receiving facility.
The Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA) surveyed cell processing facilities worldwide to elicit information about their training and competency assessment programs. Because these programs are critical to the safety of hematopoietic progenitor cell (HPC) products, the survey results are a resource to facilities to establish and maintain a competent workforce.
Results were published in Cytotherapy in Training practices of cell processing laboratory staff: analysis of a survey by the Alliance for Harmonization of Cellular Therapy Accreditation (Taylor, Slaper-Cortenbach, et al, Dec 2015, doi:10.1016/j.jcyt.2015.08.006). Respondents to the survey represented a diverse set of processing facilities and answered questions related to their facility type, location, activity, personnel, and methods used for training and competency.
Data from the survey illustrated a variety of training and competency methods, with some being more common than others. The results may help processing facilities with establishing or improving their training and competency programs.