ENS 46386
ENS Event | |
|---|---|
04:00 Nov 2, 2010 | |
| Title | Agreement State Report Involving a Medical Event Due to a Dosage Differing from the Prescribed Dose |
| Event Description | The following information was received via fax from the Commonwealth of Pennsylvania:
Notifications: On November 2, 2010 PaDEP [Pennsylvania Department of Environmental Protection] Central Office was notified by the licensee of a medical event involving a dosage that differs from the prescribed dose by 20% as required under 10 CFR 35.3045. This event also meets the criteria for Abnormal Occurrence reporting. Event Description: On November 2, 2010 a patient was undergoing brachytherapy treatment for prostate cancer. A partial seed implant of 85 Gy was prescribed, however, the full treatment of 144 Gy was implanted. This event was discovered upon completion of the procedure. Cause of the Event: Human Error Actions: The Department is awaiting more event details at this time and plans to send regional staff to conduct a follow-up inspection. Final event details will be communicated in an NMED and Abnormal Occurrence report. PA Report ID No.: PA100025
NOTIFICATIONS: The licensee called the PaDEP Bureau of Radiation Protection on the afternoon of November 2, 2010 to provide a 24-hour verbal notice of a Medical Event. The event involved a patient dosage that differed from the intended [written directive] dose by greater than 20%, consequently requiring a 24-hour report per 10 CFR 35.3045(a)(1)(i). Subsequently, the licensee provided a written report to PaDEP on November 5th. EVENT DESCRIPTION: On November 2, 2010 a patient was undergoing brachytherapy Cesium-131 seed implant treatment for prostate cancer. A partial seed implant of 85 gray (Gy) was directed, with a 45 Gy follow-up external [IMRT] beam therapy. However, the full seed treatment of 114 Gy was implanted. The event was discovered upon completion of the implants. CAUSE OF THE EVENT: Human error was the cause of the event. Specifically, the incorrect prescribed prostate dose was entered into the licensee's VariSeed planning system (i.e.114 Gy vs. 85 Gy), and an incorrect seed order was placed with the vendor. The error persisted because the licensee's staff did not directly compare the written directive to the printed treatment plan. Such a comparison would have alerted the staff to the error. ACTIONS: The PaDEP performed a reactive inspection at the hospital on 11/4/2010. Warren General also initiated the following changes: Their current Operating Room (OR) "time-out" procedure will be altered to include the expected prescription dose. A copy of the original written directive will be utilized in the OR for reference before and during the implant. Forms will be amended to have the physician's written directive and the planned dose on the same form for easy review and comparison. Lastly, the weekly physics chart review that involves a check of the written directive has been altered such that a summary sheet that is normally used for external beam patients will now also be used for seed implant patients. This event will be also communicated to NRC via NMED. However, there was an initial miscommunication between the licensee and PaDEP. The full treatment of 114 Gy was used, not 144 Gy. Thus, there will not be an Abnormal Occurrence report from PaDEP to NRC. 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. |
| Where | |
|---|---|
| Warren General Hospital Warren, Pennsylvania (NRC Region 1) | |
| License number: | PA-0083 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+29.72 h1.238 days <br />0.177 weeks <br />0.0407 months <br />) | |
| Opened: | Joe Malnic 09:43 Nov 3, 2010 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Dec 28, 2010 |
| 46386 - NRC Website | |
Warren General Hospital with Agreement State | |
WEEKMONTHYEARENS 463862010-11-02T04:00:0002 November 2010 04:00:00
[Table view]Agreement State Agreement State Report Involving a Medical Event Due to a Dosage Differing from the Prescribed Dose 2010-11-02T04:00:00 | |