Radiotherapy Quality Assurance Varian Medical Systems’ Perspective Roman Wicha, PhD Manager, Treatment Management System Time-out Errors deconstructed IGRT is position QA Additional reporting

Responsibility for Quality Assurance in RT Published QA guidelines state that responsibility to design and execute a QA program belongs to the medical facility Establish the type and frequency of QA tests Reflect how the devices are used clinically Covers the specific combinations of devices in the facility

Quality Assurance Machine (device) specific Patient Specific Process Verifies correct operation of the device Analyzes drifts from commissioning baseline Patient Specific Verifies patient specific data (e.g. treatment plan) Procedure depends on patient treatment technique Process Verifies that clinical process is followed Improves adherence to standards of care

Quality Assurance in radiotherapy clinics QA is an integral part of the Radiotherapy clinical process Historical emphasis has been on Dosimetric QA Routine Machine QA & Patient QA Opportunity to round out QA in Radiotherapy Incorporate complementary Process QA CONFIDENTIAL

Modern Radiotherapy Process Treatment prescription Plan review & approval Diagnostic imaging Treatment planning Target definition Pre-treatment QA Setup verification Treatment delivery User configurable: pre-defined far from the line of fire Optional: May be applied at any point in the process, as appropriate Reinforces best clinical practice Different checklists can be used for different treatment techniques, more detailed for more complex procedures, less detailed for routine procedures May require different levels of sign-off authority commensurate with the complexity or risk of the procedure Can enforce mandatory completion before process can advance to next stage Checks may be automatic or manual Many opportunities for light-weight Process QA

Process QA via a checklist Requires a change to current clinical practice Other medical specialties have adopted “time-out” to resolve all concerns before beginning a procedure E.g. The Universal Protocol Can be implemented manually initially Simple pen and paper approach is workable Can be implemented within the devices eventually Better compliance and auditing Streamline checklist process

Checklist as a “time-out” User Configurable Optional Content pre-defined far from the line of fire May be used at any point in the process Context specific Rules-Based Checks may be manual or automatic Can enforce mandatory completion before process can advance to next stage Reinforces adherence to clinical best practice Risk-Adjusted Sign-off levels commensurate with complexity or risk of procedure Different checklists for different techniques More details for more complex treatments User configurable: pre-defined far from the line of fire Optional: May be applied at any point in the process, as appropriate Reinforces best clinical practice Different checklists can be used for different treatment techniques, more detailed for more complex procedures, less detailed for routine procedures May require different levels of sign-off authority commensurate with the complexity or risk of the procedure Can enforce mandatory completion before process can advance to next stage Checks may be automatic or manual

“Time-out” adopted by Surgeons We anticipate that Radiotherapy will follow other medical specialties and adopt checklists to improve patient safety. We intend to facilitate this adoption within our software applications.

Checklist as a “Time-out” in Radiotherapy Complements existing QA methodologies Should increase compliance with current practice Can be implemented at key points in the clinical process More details for more complex or risky procedures Can be implemented within the RT software Makes it more practical

Thank you CONFIDENTIAL