ENS 45727: Difference between revisions

v t e ENS Event
05:00 Jan 21, 2010
Title	Agreement State Report - Brachytherapy Implants Outside of the Intended Treatment Area
Event Description	The following information was received via fax: Notifications: The licensee called the PaDEP Southeast Regional Office on the morning of February 25, 2010 to provide a 24-hour verbal notice of a possible Medical Event. The SERO and Central Office discussed the known facts around noon time, and understood the U Penn RSO would be providing more information via email. DEP also provided a verbal notice to NRC Region 1 regarding this possible ME on 2-25-2010. On January 21, 2010 a patient was treated by brachytherapy for prostate cancer with sixty five (65) iodine-125 (I-125) seeds. The I-125 seeds were implanted using real time dosimetry under ultrasonic guidance. The written directive called for a therapeutic radiation dose of 145 gray (Gy) [14,500 rad] to the prostate volume, plus 5 millimeters of margin, using interoperative planning. On February 23, 2010, the patient returned for a 30 day post-implant CT. The scan showed that the implanted seeds were "in an appropriate pattern," but outside the intended target. On February 24th the licensee's Radiation Oncology group determined that an additional quality assurance review was warranted, but the RSO should notify PaDEP/BRP [Pennsylvania Department of Environmental Protection/Bureau of Radiation Protection] regarding the case. Based on the information known at this time, PaDEP/BRP believes this ME is reportable under 10CFR35.3045, and may be an Abnormal Occurrence (AO). The state will perform a reactive inspection next week, and coordinate with NRC Region I; because of their ongoing evaluation of pre-April 2008 brachytherapy implants at U Penn, and at the Philadelphia VA hospital. Cause of the event: A new ultrasound unit that was used to place the I-125 seeds may have been malfunctioning. Actions: There is a reactive inspection scheduled to investigate this apparent ME at U Penn on March 2, 2010. PaDEP/BRP will also ask U Penn to evaluate the need for FDA notification regarding the ultrasound unit. Event Report ID Number: PA100002 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.

ENS 45727 +/-
Where
University Of Pennsylvania Philadelphia, Pennsylvania (NRC Region 1)
License number:	PA-0131
Organization:	Pa Bureau Of Radiation Protection
Reporting

Agreement State
Time - Person (Reporting Time:+853.9 h35.579 days <br />5.083 weeks <br />1.17 months <br />)
Opened:	David J. Allard 18:54 Feb 25, 2010
NRC Officer:	Joe O'Hara
Last Updated:	Feb 25, 2010
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v • d • e

v t e Emergency Notification System
University of Pennsylvania with Agreement State
WEEKMONTHYEAR2024-04-17T04:00:00 [Table view]
[ENS list for University of Pennsylvania]

@@ Line 3: / Line 3: @@
 | facility = University Of Pennsylvania
 | Organization = Pa Bureau Of Radiation Protection
-| license number = Pa-0131
+| license number = PA-0131
 | region = 1
 | state = Pennsylvania

ENS 45727: Difference between revisions

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