Checklist Ensures Adherence to Recommended CAR T-Cell Administration Processes

ANAHEIM, CA — Use of a checklist identified improvement opportunities and ensured future adherence to the complex, multistep clinical process of CAR T-cell therapy, an oral presentation at the Oncology Nursing Society (ONS) 44th Annual Congress has shown.

Chimeric antigen receptor (CAR) T-cell therapy (CAR-T) is an emerging line of immunotherapy in which T cells are genetically engineered to target and destroy cancer cells. To date, 2 products have been granted US Food and Drug Administration (FDA) approval for the treatment of specific hematologic malignancies: axicabtagene ciloleucel (Yescarta®) and tisagenlecleucel (Kymriah®). 

These products are only available commercially at facilities certified through a Risk Evaluation and Mitigation Strategy (REMS) program. REMS programs provide specific guidelines for administration, adverse effect management, and patient education, and ensure the treatment benefits to the patient outweigh the risks, explained Christina Barrow, BSN, RN, BMTCN®, of Baylor University Medical Center in Dallas, Texas. 

Baylor University Medical Center was certified to administer axicabtagene ciloleucel for the treatment of relapsed/refractory (R/R) large B cell lymphoma in January 2018, and certification to administer tisagenlecleucel for the treatment of young adults with B-cell precursor acute lymphoblastic leukemia (ALL) and adults with R/R large B-cell lymphoma occurred in October 2018.  

The certification process involves extensive review and incorporation of the recommended administration process from the manufacturer, including cell collection, cellular product infusion, activator administration, and management of postinfusion complications. In addition, the team at Baylor consulted with key personnel from the Blood and Marrow Transplant (BMT) team to design a checklist that would ensure adherence with these pretreatment steps as well as the administration process:

• Documentation of patient receiving the wallet card
• Availability of 2 doses of tocilizumab for the patient
• Required specific patient education, based on the product insert
• Prerequisites for administration, per the facility’s program standards and the product insert
• Vital signs and premedication reminder
• Steps for thawing the product
• Steps for administering the product

An in-service was conducted to explain the checklist and the process to the staff, and a CAR-T therapy resource binder was created and placed on the unit as a reference for the bedside staff.

Since the facility received its certification to administer the 2 CAR-T cell therapies, 7 patients have undergone therapy with axicabtagene ciloleucel; no patients have undergone treatment with tisagenlecleucel. Chart audits are completed quarterly by the BMT program quality manager. The audits focus on compliance with program standards and adherence to required processes.

Initial audit results identified a need for improvement in nursing documentation of patient education and availability of tocilizumab on the inpatient unit, both of which are components on the CAR-T infusion checklist. After a review by key nursing staff, the review team concluded that the checklist was complete, clear, and accurate. The deficits identified in the audit were primarily due to inconsistent utilization of the checklist. The unit’s nursing manager selected a core group of “CAR-T Champions” to reeducate the staff, including reinforce the use of the checklist, and act as a resource on the unit. 

The checklist is being built into the facility’s new electronic health record. Evaluation of the CAR-T cell therapy program is ongoing, as required by our facility’s BMT program standards and REMS requirements.

Reference

Barrow C. Developing a checklist to ensure staff compliance to chimeric antigen receptor (CAR) T cell infusion requirements. Oral presentation at: ONS 44th Annual Congress; April 11-14, 2019; Anaheim, CA.