Build the program

Quality is the foundation, not the final checkpoint

Strong quality systems make CAR-T delivery consistent and safe from the first patient forward. Procedures, training, labeling and data are what turn a complex therapy into a repeatable one.

Build quality in from the start

Most of what a CAR-T quality system needs already exists in a community practice in some form: written procedures, staff training, product handling controls, and outcome tracking. The work is adapting them to CAR-T and confirming your team knows its role. Take the time to evaluate how each process will actually run in your facility with the resources you have.

Approaches to Ensuring High-Quality CAR-T Care

In addition to the Quality Program components below, it is critical to understand and support regulatory compliance. Examples include filing with state, local and federal authorities for treating patients clinically; labeling and chain of custody management; data management; and safety monitoring and reporting. Licensure requirements vary by state and by which activities you perform on site. A distributor can take on part of the compliance workload under contract.

Written SOPs keep care consistent as staff change and volume grows. Build or adapt procedures covering the quality management system, chain of identity and custody, labeling and label reconciliation, apheresis collection, cryostorage and thaw, bridging treatment, pre-medication and infusion, CRS and ICANS grading and management, emergency escalation and ICU transfer criteria, immunosuppressant access, patient and caregiver education, post-infusion observation and discharge, and outpatient monitoring.

Products are patient-specific and cannot be replaced, so identity has to be verified at every handoff. Best practice records the manufacturer identifier and the Donation Identification Number at collection, then double-checks patient name, medical record number, date of birth, DIN and manufacturer identifier on the apheresis bag and again at product receipt, alongside packaging integrity, transit temperature, bag count and expiration date. Label reconciliation should be a written, two-person step.

Decide early where CAR-T information lives. Best practice places the apheresis order in the same computerized order entry system as the product prescription and administration record, which improves traceability and lets pharmacy confirm washout periods for G-CSF, cytotoxics and steroids. You also need a route for manufacturer portal documentation, certificates of analysis and delivery notes, and storage temperature monitoring with a 24-hour alarm.

Identify dedicated space for infusion and for post-infusion monitoring. Think through how to collaborate to ensure adequate and timely adverse event management.

Decide what you will measure before the first infusion. Useful measures include incidence and grade of CRS and ICANS, hospital admissions and ICU stays, and complete response at 100 days and one year. Submission to the CIBMTR registry is recommended but not required, while compliance with manufacturer or sponsor reporting is mandatory. Manufacturers remain required to follow patients for 15 years for long-term safety, due to FDA requirements.

Understanding Accreditation: FACT, AABB, and Others

Accreditation is one tool for testing your team's readiness. Accrediting bodies publish useful checklists and assessment tools. FACT offers Community Immune Effector Cell Standards and AABB provides accreditation for Standards for Cellular Therapy Services. Manufacturers will support through robust onboarding process to ensure readiness.

Visit FACT Visit AABB

Important

Accreditation is voluntary, and one tool for quality assurance. It is not mandatory by Medicare, Medicaid, FDA or any government agency.

Accreditation and Payer Requirements

Accreditation is one tool you may want to consider to improve the readiness of your team. If you decide to use an accrediting agency, they have checklists and tools that may help you have a robust system. Third-party payers may require accreditation for payment coverage. Coverage policies vary, so confirm the requirement with each contracted payer.

Reimbursement, Billing & Coding