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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5219313 July 2016 06:00:00Agreement StateAgreement State Report - Misadministration During a Thyroid Ablation ProcedureThe following was reported by the Colorado Department of Health Radioactive Materials Unit via email: CDPHE (Colorado Department of Public Health and Environment) became aware of the misadministration on the morning of Monday August 22, 2016. The event was reported to CDPHE on Friday August 19, 2016 at approximately 1630 (CDT) via a message that was left on an office voicemail inbox. The misadministration occurred during a thyroid ablation procedure on July 13, 2016. The prescribed dose was 75 milliCuries of I-131, and 78 milliCuries was delivered to the patient. The patient became aware that she was pregnant at the time of the procedure and notified St. Mary's Hospital and Medical Center on Tuesday, August 16, 2016. The gestation at time of procedure was estimated to be 9 days post conception. The Hospital's RSO reported an estimated dose to fetus of approximately 20 centiGray. The patient was given a pregnancy test prior to the procedure and the test results were negative. The licensee is claiming the misadministration was a result of patient non-compliance because the patient was instructed not to have sexual contact prior to the procedure. A written report from the licensee is pending; and will be followed-up by a formal investigation. Colorado Event Identification Number: CO16-I16-17 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 4943110 October 2013 06:00:00Agreement StateAgreement State Report - Potential Dose from Deceased Patient with Previously Administered Iodine-131

The following was received from the State of Colorado via email: CDPHE (Colorado Department of Public Health and Environment) received telephone notification on 10/11/13 at approximately 2:00 p.m. of a deceased patient who had been administered 150 mCi of I-131 approximately 10-14 hours prior to his death. A male patient, 35 years of age, was administered 150 mCi of I-131 at St. Mary's Hospital and Medical Center on Wednesday October 9, 2013. The RSO at St. Mary's was notified on Thursday that the patient had passed at some point in the night of the 9th. County EMTs as well as staff from the county coroner's office were called to the scene and examined the body prior to the confirmation of death and the transport of the body to the Montrose Memorial Hospital in Montrose, Colorado.

Section 7.22 of the Colorado Regulations require that the licensee shall notify the Department (Colorado Department of Public Health and Environment) by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive exposures in excess of 4.14 as a result of the deceased's body.

At this time, the licensee has consulted with and performed contamination surveys of all of the members of the public who have come into contact with the deceased and has situated the body in a secluded portion of the morgue with lead aprons to reduce any potential exposure. The preliminary estimates on dose indicate that the highest dose would have been to the driver of the vehicle which was used to move the body and that dose is estimated to be 30 mrem. The pathology staff at the hospital would like to perform an autopsy since the patient was 35 years of age and was not expected to pass based on medical history.

The Department (Colorado Department of Public Health and Environment) will keep communications open as details of the autopsy schedule are finalized and provide guidance on best practices and ALARA techniques for handling of the body.

The licensee will submit a written report with more detail within thirty days. No other details are available at this time.