Biology of Blood and Marrow Transplantation | 2019
Nursing Training Requirements for Implementation of a Commercial T Cell Product
Abstract
Topic Significance & Study Purpose/Background/Rationale In 2016, a Comprehensive Cancer Center (CCC) created an Immunotherapy outpatient clinic dedicated to treating patients with T cell-based therapies. In 2017-18, this CCC obtained site certification for commercially approved Chimeric Antigen Receptor (CAR) T cell products and implemented an operationalization plan for best practices for CAR-T cell patient care. One essential aspect of this care practice implementation was comprehensive nursing education process incorporating the FDA mandatory patient education requirements, product administration, side effect recognition and treatment. Methods, Intervention, & Analysis In accordance with the site certification process, our nurses underwent REMS (Risk Evaluation and Mitigation Strategy) training which provided a product specific overview and treatment recommendations. Additional trainings were then conducted for product administration, product specific patient education requirements, T cell specific side effects, and documentation requirements. One of our final steps prior to implementation was a multidisciplinary review of the programmatic implementation plan which outlined the process for financial clearance, online product ordering and management, timing considerations for apheresis and cell formulation, and coordinating inpatient/outpatient cell infusions. Findings & Interpretation The comprehensive education provided nurses with foundational, product specific and logistical considerations to help support a successful implementation plan for each commercial product. In addition to didactic training, reference tools, including a product infusion policy, standard work documents, and a workflow to facilitate hospital admission were developed. These tools have demonstrated effectiveness in providing nurses with product specific implementation details and continue to be adapted as new improvements and processes are made. Discussion & Implications Nurses are on the forefront of caring for these novel CAR T cell patients. Specific clinical education and establishment of standard protocols are essential to creating best clinical practices. Implementation of these state of the science care modalities is a multidisciplinary effort, and nurses play a primary role in many key aspects of care, including patient education, product collection and infusion, side effect recognition and symptom management. With future increases in the utilization of novel T cell-based therapies, comprehensive nursing education and training is imperative for the realization of best patient outcomes.