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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 51069 | 24 February 2015 06:00:00 | 10 CFR 35.3045(a)(1) | Incorrect Dose Recorded on Prescription Directive | This is a notification, pursuant to 10 CFR 35.3045(a)(1), of a medical event that occurred at the VA Salt Lake City Health Care System, Salt Lake City, Utah. On February 24, 2015, a dosage of 30.8 millicuries of I-131 sodium iodide (capsule form) was administered to a patient for a thyroid ablation. The prescribed dosage on the written directive was incorrectly annotated as 3 millicuries. The basis for identifying this as a medical event is the administered dosage differed from the prescribed dosage, as annotated on the written directive, by more than 20 percent. The medical event was discovered today (May 13, 2015) during an inspection, conducted by the National Health Physics Program (NHPP). Interview of the Radiation Safety Officer revealed the standard dosage for a thyroid ablation is 30 millicuries of I-131 sodium iodide (capsule form). Interview of the authorized user (a physician) revealed the intended prescription was for 32 millicuries of I-131 sodium iodide (capsule form). No biological harm to the patient is expected since the thyroid ablation was successfully performed. The patient and attending physician were not informed of the incorrect annotation on the written directive since the thyroid ablation was successfully performed, as clinically intended, with a dosage of I-131 sodium iodide (capsule form) within an acceptable range of the authorized user's intent. The inspection is ongoing with causal factors and corrective actions being developed. Additional information will be provided in a 15-day written report, to be submitted to NRC Region III. National Health Physics Program notified NRC Region III (Patricia Pelke, Chief, Materials Licensing Branch Chief) of the medical event by telephone. The Department of Veterans Affairs holds NRC License No. 03-23853-01VA, a master materials license. Permits are issued under the license to Veterans Health Administration facilities. The VHA permit number for the facility involved in this medical event is 43-03299-01. National Health Physics Program makes required notifications to NRC. " 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 50833 | 29 December 2014 06:00:00 | 10 CFR 35.3045(a)(1) | Medical Event - Underdose | This is a notification, pursuant to 10 CFR 35.3045(a)(1), of a medical event that occurred at the VA Medical Center, Durham, North Carolina. On December 29, 2014, a dosage of 1.569 millicuries of I-131 sodium iodide was administered to a patient for a diagnostic whole body scan, and the prescribed dosage on the written directive was 2 millicuries. The basis for identifying this as a medical event is that the administered dosage differed from the prescribed dosage by more than 20 percent and the absorbed dose is estimated to differ from that dose that would have resulted from the prescribed dose by more than 50 rem to remnant thyroid tissue. The medical event was discovered today (February 19, 2015) during a routine audit by the facility Radiation Safety Officer. The facility has notified the referring physician and the patient of the medical event. No biological harm to the patient is expected from this under-dosing event. The NHPP (National Health Physics Program) plans to perform a reactive inspection regarding the medical event within the next 10 working days. A 15-day written report for the medical event will be submitted to NRC Region III. National Health Physics Program notified NRC Region III (Patricia Pelke, Chief, Materials Licensing Branch Chief) of the medical event by telephone. Additional information: The Department of Veterans Affairs holds NRC License No. 03-23853-01VA, a master materials license. Permits are issued under the license to Veterans Health Administration facilities. The VHA permit number for the facility involved in this medical event is 32-01134-01. National Health Physics Program makes required notifications to NRC." 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 44522 | 24 September 2008 05:00:00 | 10 CFR 35.3045(a)(1) | Medical Dose Less than 80% of Prescribed Dose | In response to medical events discovered at the VA Medical Center Philadelphia, which have been reported under Event Number 44219, reviews are ongoing of samples of patient charts from other VA facilities with permanent prostate seed implant brachytherapy programs. As the result of these ongoing reviews, possible medical events were discovered on September 24, 2008, for 7 patients treated at the VA Medical Center in Jackson, Mississippi. These 7 possible medical events involved seed distributions in the patients that may result in D90 doses less than 80% of the prescribed doses. These circumstances are interpreted as meeting the definition of a medical event under 10 CFR 35.3045. (The D90 is the dose that covers 90% of the volume of the prostate.) The VHA National Health Physics Program will ensure that the medical center follows NRC requirements for notification of the patients. These treatments and their possible effects on the patients are under review by medical experts. A 15-day written report of these 7 possible medical events will be submitted to NRC Region III. We will notify our NRC Project Manager, Cassandra Frazier (NRC Region III), of these possible medical events. Additional Information Department of Veterans Affairs has a Master Materials License (MML) from the NRC: License No. 03-23853-01VA. Permits are issued under the MML to VA facilities. The VA submits reports to the NRC through the VHA's National Health Physics Program office located in North Little Rock, AR. Address of permittee involved in this event: VA Medical Center, 1500 East Woodrow Wilson Drive, Jackson, Mississippi 39216. VHA permit number of permittee involved in event: Permit No. 23-08786-01.
This report is an update to Event Report Number 44522. As the result of an ongoing review, an additional possible medical event was discovered on October 7, 2008. This brings the total number of possible medical events to eight (8) under Event Report Number 44522. The circumstances are similar to those previously reported for this event number. A 15-day written report of this additional medical event will be submitted to NRC Region III. We will notify our NRC Project Manager, Cassandra Frazier (NRC Region III) of this additional possible medical event. Notified the R3DO (Lara) and FSME (Einberg).
This report is an update to Event No. 44522. An additional medical event was discovered on October 29, 2008, for a patient treated at the VA Medical Center in Jackson, Mississippi. This medical event involved a patient who had undergone permanent implant prostate seed brachytherapy using iodine-125 seeds. The resulting seed distribution in the patient was associated with a D90 dose to the treatment site that was less than 80% of the prescribed dose. The circumstances were interpreted to meet the definition of a medical event under 10 CFR 35.3045(a)(1). A total of eight (8) events have been previously reported to the NRC under this event number. This additional event brings the total number of events to nine (9) for this facility. A 15-day written report on this additional medical event will be submitted to NRC Region III. I have notified our NRC Project Manager, Cassandra Frazier (NRC Region III), of this additional medical event. Notified R3DO (Kozak) and FSME (Burgess).
This report is an update to Event No. 44522. One additional medical event was discovered on December 16, 2008, for a patient treated at the VA Medical Center, Jackson, Mississippi. This medical event involved a patient who had undergone permanent implant prostate seed brachytherapy using iodine-125 seeds. The resulting seed distribution in the patient was associated with a D90 dose to the treatment site that was less than 80% of the prescribed dose. The circumstances were interpreted to meet the definition of a medical event under 10 CFR 35.3045(a)(1). A total of nine (9) events have been previously reported to the NRC under this event number. This additional event brings the total number of events to ten (10) for this facility. A 15-day written report on this additional medical event will be submitted to NRC Region III. We have notified our NRC Project Manager, Cassandra Frazier (NRC Region III), of this additional medical event. Notified R3DO (Skokowski) and FSME (Flannery). 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 43265 | 31 May 2006 05:00:00 | 10 CFR 35.3045(a)(1) | Medical Event - Patient Received Dose Greater than Prescribed | The possible medical event occurred at a broad-scope permittee authorized under the master materials license issued to the Department of Veterans Affairs, NRC License 03-23853-01VA. The permittee is VA Eastern Colorado Health Care System, Denver, Colorado. The possible medical event occurred on May 31, 2006. The possible medical event was discovered on March 28, 2007. The basis for the possible medical event is under 10 CFR 35.3045(a)(1)(i) and involved administration of a dose different from the dose prescribed in the written directive. Specifically, the written directive for a patient therapy procedure listed the dose to be 15 millicuries Iodine 131 when in fact 30 millicuries was given to the patient. Since the clinical intent was for the patient to receive 30 millicuries, the possible medical event will not have any adverse impact on the patient. The permittee has implemented corrective actions to prevent a recurrence of the circumstances that resulted in the possible medical event. The Department of Veterans Affairs will evaluate the circumstances related to the possible medical event and submit a written report to NRC, Region III, within 15 days.
This event has been reviewed and determined to be a reportable medical event. 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 41443 | 24 February 2005 05:00:00 | 10 CFR 35.3045(a)(1) | Medical Event | The following information was provide by the licensee via facsimile: (The Department of Veteran Affairs National Health Physics Program called) per 10 CFR 35.3045 to notify (the NRC) of a possible medical event at the VA Medical Center, Durham, North Carolina, a permittee under the VA license. This event was discovered on February 25, 2005. On February 24, 2005, a permanent-implant prostate brachytherapy procedure was performed at the medical center. 84 Iodine-125 seeds were implanted in the patient. These seeds had around 400 microcuries per seed. A number of seeds were mistakenly placed in fatty tissue, outside of the intended area of treatment. Based on a preliminary evaluation, a possible medical event occurred since the dose to the prostate was possibly more than 20 percent less than that prescribed and a dose to tissue other than the treatment site is possibly more than 50 rem and greater than 50% of the prescribed dose. The authorized user notified the patient and will notify the referring physician within 24-hours of discovery. The National Health Physics Program intends to conduct a reactive inspection next week. |