AGREEMENT STATE REPORT - UNDERDOSE EXCEEDING 20 PERCENT OF THE PRESCRIBED DOSE
The following was received via email from the state of Illinois:
"During a routine inspection [by the State of Illinois] of Riverside Medical Center, IL-01242-01, conducted on January 29, and continued document review conducted February 5, 2019, inspectors identified an apparent under dose to a patient receiving I-125 seed prostate therapy. The event occurred in April of 2016. Of the six patient records reviewed (all 2016), one post operational dosimetry report indicated a D90 of 120.7 Gy, resulting in a 24.5 percent variance from the prescribed dose of 160 Gy. Two of the patient records did not have a post operational dosimetry report and inspection findings indicate the licensee does not have written procedures for prostate seed therapies which ensure the administrations are in accordance with the written directive. As a result of the lack of procedures, the determination of a 20 percent variation from the prescribed dose is being compared against the D90 value following prior recorded NMED [Nuclear Materials Events Database] events and NRC guidance. The licensee has been notified and will submit a written report within 15 days.
"The licensee is not actively engaged in brachytherapy and the authorized user is no longer with the licensee. Agency enforcement action will ensure either procedures are established or modality authorization is removed. Pending appropriate address of the patient's treatment and root cause by the licensee, a reactive inspection is not being conducted in accordance with Management Directive 8.10, Section III(A)(3). This report will be updated as additional details become available."
Item Number: IL190007
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. |