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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5077026 January 2015 19:30:00Agreement StateAgreement State Report - Medical Misadministration

The following report was received from the State of Maryland via email: On 1/27/15 at 0830 EST, (Maryland Department of the Environment (MDEP) personnel) discussed preliminary findings (with the licensee) regarding an alleged medical misadministration at the Cancer Center at Gaithersburg with the Medical Physicist and RSO (Radiation Safety Officer). The initial notification came to (the Maryland) RHP (Radiological Health Program) on 1/26/15 at 1600 EST. The incident occurred on 1/26/15 at about 1430 EST at the licensees address at 808 West Diamond Avenue, Gaithersburg, Maryland 20878. The incident involved a skin cancer therapy treatment to the bridge of the nose to a female patient with a Elekta/Nucletron HDR (High Dose Rate). The licensee has done previous skin treatments but this was the first skin treatment performed at the bridge of the nose. (The Licensee) stated no history of previous medical incidents. The written directive was for 3900 centiGray to be delivered over 6 fractions. The first fraction was intended to be 650 centiGray, but the licensee administered 1300 centiGray. Preliminary discussion of root cause indicated that the patient was not fully conscious and in distress with the use of a 3 centimeter diameter applicator and a decision was made to change the applicator size to 2 centimeters. The treatment plan initially determined for the 3 centimeter diameter applicator was mistakenly added to the treatment plan determined for the 2 centimeter applicator. The Medical Physicist says there is no dialog warning on the software to indicate that an addition will occur. The licensee stated that the husband of the patient has been notified. Potential future erythema of the patient skin will be followed. Present at the therapy - Oncologist, Medical Physicist, and Therapist. (The Medical Physicist) stated that the licensee will re-examine all quality assurance oversight for HDR therapies. Preliminary consideration for corrective actions: All new treatment plans will be given new identities (and) the licensee will explore ways to delete previous treatment plans. The licensee is working to have the written report to RHP prior to end of the 1/27/15 business day. (The Medical Physicist) was informed that RHP will investigate the incident. 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.

  • * * UPDATE FROM ALAN JACOBSON TO JEFF HERRERA ON 01/28/2015 AT 0828 EST * * *

The following information was provided by the State of Maryland via email: The female patients age is 67 and the Elekta/Nucletron HDR Model is 105.002 Microselectron 3. The activity of the source is approximately 5.2 Ci. Notified the R1DO (Cahill) by phone and NMSS Events Notification (Email).

  • * * EVENT RETRACTED AT 1205 EDT ON 3/26/2015 BY RAY MANLEY TO MARK ABRAMOVITZ * * *

This event is retracted because the dose delivered matched the written directive. Due to a software error, the dose was reported as double the actual dose. The patient, doctor and NMED have been notified. Notified the R1DO (Jackson) and NMSS Events Resource (via e-mail)