Background/Case Studies: A community hospital-based cancer center in a rural state established an adult autologous hematopoietic stem cell transplant program in 2021, including a new cellular therapy laboratory (CTL) to cryopreserve, store, and prepare cells for infusion. No technologists with previous cell processing experience were employed by the hospital. A training program was developed by the CTL medical director. This study reviews processing and patient outcomes during the first 17 months in operation to evaluate effectiveness of our training protocol.
Study
Design/Methods: In brief, two technologists with blood banking experience underwent training consisting of one week of offsite training at an accredited cell processing laboratory, an online certificate course in cellular therapies, an online seminar in cryopreservation, additional lectures provided by the medical director, and participation in SOP writing and process validations. A 3rd technologist was trained approximately 7 months after start of operations, using a checklist guiding the technologist through a curriculum consisting of policy reading, task observation, aseptic technique practice, and performance of hematopoietic progenitor cell, apheresis (HPC,A) processing under observation; background education in cellular therapy was provided by the CTL medical director. Retrospective review of all autologous HPC,A processing and environmental surveillance cultures from 10/2021 to 03/2023 was performed. Data reviewed included rates of environmental and product contamination, processing errors/deviations, cryopreserved product quality, and patient outcomes.
Results/Findings: Environmental settle plates during processing showed one bacterial skin contaminant isolated in 34 events. No product post-processing bacterial and fungal cultures were positive after 14 and 28 days, respectively. A total of 4 process deviations related to technologist error occurred; 2 of these required additional culture of the product due to possible contamination risk. Fifty-two autologous HPC,A products were processed from 30 patients. Mean post-thaw testing from cryobags of 29 products showed: TNC recovery 100.3% (range 86.3-113.1), CD34+ cell recovery 81.1% (range 66.9-113.3), CD34+ cell viability 89.6% (range 83.0-95.2). Mean post-thaw testing from 32 cryovials (27 distinct products) showed: TNC recovery 90.3% (range 69.6-111.6), CD34+ cell recovery 74.1% (range 54.2-100.0), CD34+ cell viability 91.1% (range 82.6-96.6). Twenty-nine patients were transplanted with a mean CD34+ cell dose of 5.11 x 10^6/kg (range 2.69-8.67). All recipients demonstrated neutrophil and platelet engraftment; mean time to engraftment for neutrophils was 11.1 days (range 9-13) and for platelets was 16.2 days (range 12-21). Conclusions: Our training program for cellular therapy technologists is a viable option for new community-based programs with no previous experience.
Importance of research: Little information is publicly available to assist new cell processing facilities establish operations, including training of staff when no pre-existing expertise is available. Our data demonstrates one possible means of training at a new facility that can result in successful autologous HPC processing and successful transplants.
