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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 452756 August 2009 06:00:00Agreement StateAgreement State Report - Medical Dose Different than PrescribedThe following was received from the state via e-mail: This incident was reported by a medical licensee (Centura Health Penrose - St. Francis Health Services License # 197-02) on 08/06/2009. On 22 July 2009, at patient at Penrose Hospital was implanted with 70 Palladium-103 seeds, 2.5 U each on that day. The application was via a Mick applicator, using intra-operative planning with a Variseed planning system. It was noted on the C arm film taken at the completion of the implant that there was some clumping of the seeds in groups. A post implant CT scan was done on 23 July 2009. The results of the computerized dosimetry plan was evaluated on the 5 August 2009 and it was determined that the prostate gland was under dosed, receiving a dose to 90% of the prostate volume (D90) of 36.6% of the prescribed 125 Gy. The AU (Authorized User) written directive listed an expected range of D90 to be 90% to 135%. The discrepancy between actual dose and prescribed falls outside of the 20% tolerance for delivered dose according to (Colorado State Regulation) RH 7.21.1.1 (1). A full report is expected from the licensee within 30 days. 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 4522122 July 2009 06:00:00Agreement StateAgreement State Report - Medical Event

The following was received via fax from the State of Colorado. A medical licensee notified the (Colorado Department of Health) of a misadministration during a HDR (High Dose Rate Afterloader) procedure. A positioning error resulted in an estimated dose of 700 Rads to the wrong site. No other details are available at this time. The Department has initiated an investigation of this incident. The licensee did not provide the State with an event date and time in the initial event report.

  • * * UPDATE AT 1321 EDT ON 07/24/09 BY ERIC SIMPSON * * *

The following information was received by the State of Colorado via fax: The (State of Colorado Department of Health) received the following information from the medical physicist who reported the misadministration involving a therapy treatment with a High Dose rate Remote Afterloader (HDR) at Penrose St. Francis Hospital in Colorado Springs, Colorado. -The date of the misadministration was 7/21/09. -Because of the error, the dose was delivered to the entrance of the vagina, rather than intrauteral. -The patient's physician and the patient have been informed of the incident. -The applicator used in this procedure uses a collet to hold a 3 mm source tube in place. There may have been a problem with the collet, which allowed the source tube to move. -The licensee instituted corrective actions, which include additional training for all staff involved in HDR therapy treatments, and an additional check of the applicator prior to start of treatment. A full report from the medical physicist is expected within the next 7 days. No other details are available at this time. The Department has initiated an investigation of this incident. Notified R4DO (Jones) and FSME EO (Villamar). 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.