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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 51858 | 13 April 2015 04:00:00 | Agreement State | Agreement State Report - Incorrect Dose Prescribed But Correct Dose Administered | The following report was received from the Commonwealth of Pennsylvania via email: Notifications: The Licensee notified the Department April 1, 2016 of an event that occurred on April 13, 2015. It was discovered almost a year later upon routine review of written directives at the hospital. It is reportable under 10 CFR 35.3045. Event Description: A Xofigor patient was scheduled for their 6th and final treatment on April 13, 2015. The Authorized User (AU) prescribed 0.98 millicurie (mCi) on the written directive (WD). On the prescription form from the radiopharmacy, the 'dispensed amount' of Ra-223 was labeled as 99.40 microCuries (or 0.0994 mCi). The Nuclear Medicine Technologist measured '0.099 mCi' in the dose calibrator just before injecting the Xofigor into the patient (intravenously). The technologist failed to observe that the AU prescribed an activity of 0.98 mCi making the percent error between the measured vs. prescribed activity at -89.9% based upon what was documented in the WD. The hospital believes the intent of the AU was to prescribe '0.098 mCi' which is a typical dose; however, they cannot directly confirm that with the AU since the AU is no longer employed by Geisinger Health System. Another Geisinger AU who is qualified to prescribe Xofigor confirmed that 0.098 mCi would be the correct amount when calculated from the patient's weight. Consequently, if the intent was to prescribe 0.098 milliCuries, there would be no expected harm to the patient as they received the proper Xofigor activity. Cause of the event: Human error. Actions: None at this time. The licensee will submit a final report which will provide corrective actions. Notifying the patient would serve no beneficial purpose. PA Report #: PA160012 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |