EVALUATION SUMMARY: BY USING THE FOLLOWING WORKFLOW, IBA HAS BEEN ABLE TO REPRODUCE THE ISSUE: 1. IRRADIATION ABORT OCCURS, 2. USER INPUTS DELIVERED DOSE MANUALLY IN THE ONCOLOGY INFORMATION SYSTEM AND SELECTS THE ABORTED BEAM, 3. USER SELECTS THE DELIVERED DOSE FROM THE ONCOLOGY INFORMATION SYSTEM IN THE "PARTIAL REPORT" DIALOG BOX IN THE "BEAM SELECTION" SCREEN, 4. USER GOES TO "IRRADIATION PREPARATION" SCREEN AND THEN GOES BACK TO "BEAM SELECTION" SCREEN, 5. USER CANCELS AND RESELECTS THE ABORTED BEAM, 6. THE "NEXT" BUTTON IS ENABLED IN THE "BEAM SELECTION" SCREEN AND USER IS ABLE TO START IRRADIATION WITHOUT HAVING TO SELECT THE DELIVERED DOSE IN THE "PARTIAL REPORT" DIALOG BOX.. IN STEP 6, THE CORRECT BEHAVIOR OF THE SYSTEM SHOULD BE: THE "NEXT" BUTTON IS DISABLED IN THE "BEAM SELECTION" SCREEN AND USER HAS TO SELECT THE DELIVERED DOSE IN "PARTIAL REPORT" DIALOG BOX.. NOTE THAT THE "PARTIAL REPORT" DIALOG BOX IS A POPUP WINDOW WHICH IS SHOWN IN THE CENTER OF "BEAM SELECTION" SCREEN WHEN CLICKING ON "PARTIAL" BUTTON IN THE "BEAM SELECTION" SCREEN.
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Patient 1
IBA LEARNED FROM A USER THAT WHILE A PATIENT WAS BEING TREATED IN PENCIL BEAM SCANNING TREATMENT MODE, IRRADIATION WAS STOPPED AND THEN THE USER WAS ABLE TO RESTART IRRADIATION WITHOUT HAVING TO SELECT THE CORRECT PARTIAL IRRADIATION DATA. THE CUSTOMER INFORMED IBA THAT THE PATIENT IMPACTED BY THIS MALFUNCTION RECEIVED AN OVER-DOSE OF 38 MU (MONITOR UNITS) FOR ONE FRACTION OF HIS TREATMENT. THE OVER-DOSE DUE TO THAT MALFUNCTION WAS +1.8% OF THAT FRACTION (38 MU/2068 MU). THIS REPRESENTS ABOUT +0.07% OF TOTAL PRESCRIBED DOSE (25 FRACTIONS OF TREATMENT). THERE WAS NO SIGNIFICANT IMPACT ON PATIENT TREATMENT. NEVERTHELESS, IF THE MALFUNCTION WERE TO RECUR AT THE END OF THE IRRADIATION, THE WHOLE DOSE OF A FRACTION COULD BE DELIVERED TWICE, REPRESENTING A POTENTIAL OVER-DOSE OF 1GY TO 4GY.