Room: Exhibit Hall
Purpose: A self-contained linac and planning system that is tightly controlled by the vendor, such as the Halcyon, allows a rethinking of the quality management (QM). The purpose of this work is to develop a new quality and safety management program for the Halcyon.
Methods: Using the results of a hazard analysis of the Halcyon in a clinical environment, the proposed QM program relies on a simplified clinical implementation and on-going QA procedures that rely on SPC techniques for early detection of machine performance issues. After the vendor acceptance test is passed, the following steps are carried out: TG-51 absolute dosimetry, end-to-end tests, and build baselines of daily QA system. The QM program consists of the following strategies: (1) use customized tolerance/action limits for daily machine performance test (MPC), (2) routine capture of equipment exceptions, (3) follow a well-defined exception handling strategy, and (4) routine capture of Halcyon-related workflow disruptions. Customized tolerance/action limits were determined using Shawhart and EWMA control charts. An on-line machine log system was used for immediate collection of the machine faults, warnings and errors and an incident learning system was used for workflow disruptions.
Results: The customized tolerances are determined with the control chart for the large process deviation and slow process drifts, then that values are compared with the general tolerances from the vendor. Average 23 reports per month has been recorded and analyzed for the trouble shooting and preventive actions. Machine log profile has been categorized and high frequency reports were â€œCOLâ€? multileaf related fault and communication related reports.
Conclusion: Based on the early experience with a novel QM program that leverages unique machine features of the Halcyon, traditional clinical implementation and on-going QA procedures can be substantially reduced without negatively impacting quality or safety.