The following information was received from the state by facsimile:
The licensee called the PaDEP [Pennsylvania Department Bureau of Radiation Protection] South East Region at 1600 [EST] on January 20, 2011 to provide a 24-hour verbal notice of a medical event involving a dosage that differs from the intended dose by greater than 20%, consequently requiring a 24-hour report per 10 CFR 35.3045(a)(1)(i). PaDEP Central Office was notified on 1/21/2011.
During a formal review immediately following a second Yttrium-90 (Y90) TheraSphere radiation treatment on January 19, 2011, CTCA [Cancer Treatment Centers of America] noticed that the activity of microspheres delivered was different than the activity that was prescribed by the doctor. The patient was first treated with 10 GBq (about 0.27 Ci) of TheraSphere Y-90 beads for the right lobe of the liver. A second treatment of 3 GBq (about 0.081 Ci) was prescribed for the left lobe, however the activity ordered remained unchanged on the second order form, resulting in 10 GBq (about 0.27 Ci) being delivered to the patient.
Cause of the Event: Human Error.
The Department [Pennsylvania Department Bureau of Radiation Protection] has a call into the Radiation Safety Officer regarding the estimated organ dose to the liver, and will be obtaining more event details. At this time DEP plans to send regional staff to conduct a reactive inspection on 1/25/2011. Final event details will be communicated in a NMED and any other required report.
Pennsylvania Event Report: PA110001
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.