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| Entered date | Event description | |
|---|---|---|
| ENS 56481 | 20 April 2023 17:20:00 | The following information was provided by the licensee via phone and email: Per 10 CFR 35.3045(c), Veterans Health Administration (VHA) National Health Physics Program (NHPP) is reporting a possible medical event. Southern Arizona VA Health Care System (the facility), Tucson, Arizona, which holds Permit Number 02-06186-01 under the VA master materials license, reported discovery of a 'possible' medical event to NHPP at approximately (1500) CDT, April 19, 2023. A yttrium-90 microsphere therapy administration for liver cancer was performed on April 19, 2023. The intended treatment site was hepatic segment 4 of the right lobe of the liver. During the administration, performed under fluoroscopy guidance, the Authorized User (AU) / administering Interventional Radiology physician noted a change in the catheter position and elected to stop the administration. Measurements and calculations indicated the patient received about 63 percent of the prescribed activity (15.06 mCi delivered vs. 21.6 mCi prescribed). Post implant single-photon emission computerized tomography (SPECT) imaging verified that the dosage had been delivered to the correct location. The AU believes that the movement of the catheter qualifies as an emergent patient condition. The written directive was modified to include the reason for not administering the intended activity, the signature of an AU for yttrium-90 microspheres, and the date signed. NHPP in coordination with the facility and NRC will conduct further evaluation of this event to determine if the regulatory definition of emergent patient condition was met. The patient and the referring physician have been notified. At this time, short term harm to the patient is not expected. NHPP will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045. NHPP has notified the NRC Region III Project Manager. 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.
The following information was provided by the licensee via email: Veterans Health Administration (VHA) National Health Physics Program (NHPP) placed a call to NRC Operations Center on May 2, 2023, to retract Event Number 56481 (NMED Item No. 230168). NHPP reported discovery of a "possible" medical event at Southern Arizona VA Health Care System, Tucson, Arizona, Permit Number 02-06186-01, on April 19, 2023. NHPP, in coordination with the facility and NRC, has conducted further evaluation and determined that the regulatory definition of emergent patient condition, in NRC's document, Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres Licensing Guidance, was met. Therefore, this event is no longer classified as a "possible" medical event and the 15-day written reporting requirement of 10 CFR 35.3045(d) will not be completed. NHPP has notified the NRC Region III Project Manager. Notified R3DO (Peterson), R4DO (Gaddy), and NMSS Events Notification. |
| ENS 56020 | 28 July 2022 15:12:00 | The following report was received via email from the VA National Health Physics Program (NHPP): Tibor Rubin VA Medical Center, Long Beach, California, which holds Permit Number 04-00689-07 under the VA master materials license, reported the discovery of a medical event to NHPP at approximately 1450 CDT, July 27, 2022. A radium-223 dichloride (Xofigo(R)) therapy administration was performed at approximately 1115 PDT on July 27, 2022. The prescribed dosage was 211 microcuries, to be administered intravenously. Due to leakage at the IV 3-way stopcock, approximately only 160 microcuries was administered, resulting in about 75 percent of the prescribed dosage being delivered. This meets the reporting criteria of 10 CFR 35.3045 (a)(1)(i) and (a)(1)(i)(B). The patient and the referring physician have been notified. No harm is expected to the patient. NHPP will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045. NHPP notified our NRC Region III Project Manager, Bryan Parker. 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 55124 | 5 March 2021 14:03:00 | The following was received from the Veterans Health Administration (VHA) via E-mail: Per 10 CFR 20.1906(d), VHA National Health Physics Program is reporting receipt of a package of radioactive material with removable surface contamination on the outside of the package greater than NRC reporting limits. The package was received Friday, March 5, 2021, at 1032 CST at the Robert J. Dole VA Medical Center in Wichita, Kansas. This facility operates as a satellite location of the VA St. Louis Health Care System which holds permit number 24-00144-05 under the VHA master materials license. The package was checked-in and surveyed upon receipt around 1032 CST. Three wipe tests performed on the external surface of the package indicated a removable contamination level that exceeded the regulatory limit of 240 dpm/cm2 for beta-gamma emitters (reported as 13,000 - 45,000 dpm/300 cm2 not corrected for wipe efficiency). The package contained two unit doses of F-18. Analysis of the wipe test confirmed a 511 keV peak associated with positron emission tomography (PET) material. Two wipe tests of the interior of the delivery package resulted in levels below background. The patient dosages inside the package were not impacted and were able to be used. The dosage was shipped from Cardinal Health out of 410 S. Emporia St., Wichita, Kansas, which was also the delivery carrier. The facility Nuclear Medicine Technologist (NMT) immediately notified the delivery carrier by phone about the contaminated package at 1040 CST. The radiopharmacy notified the facility at 1100 CST that the driver and transport vehicle had been surveyed with no contamination noted. This package is the last delivery of the day. Because of the short half-life of F-18, the package will remain on the delivery rack for decay and will be returned to the Radiopharmacy on Monday. The NMT will perform extensive end of the day wipe tests in the hot lab to ensure contamination has not spread. VHA National Health Physics Program, who manages the master materials license, was notified of the incident around 1130 CST. |
| ENS 54822 | 6 August 2020 16:32:00 | A Y-90 microsphere therapy administration was performed on August 5, 2020, (at VA Boston Healthcare System in Boston, Massachusetts). The prescribed dose was intended for the right lobe of the liver. Post implant imaging on that day indicated that the dosage of microspheres was unintentionally administered to a portion of the left lobe of the liver. The patient and the referring physician have been notified. The National Health Physics Program (NHPP) will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045. NHPP notified our NRC Region III Project Manager (Parker). 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 54547 | 27 February 2020 10:38:00 | The following was received from the Veterans Health Administration via E-mail: Per 10 CFR 20.1906(d), Veterans Health Administration (VHA) National Health Physics Program is reporting receipt of a package of radioactive material with removable surface contamination on the outside of the package greater than NRC reporting limits. The package was received Thursday, February 27, 2020, at around 0710 EST by the North Florida/South Georgia Veterans Health System (Permit No.: 0912467-02) in Gainesville, Florida. This facility holds permit number 09-12467-02 under the VHA master materials license. The package was checked-in and surveyed upon receipt around 0710 EST. Wipe tests performed on the external surface of the entire package indicated a removable contamination level of around 560 dpm/cm2 as compared to the regulatory limit of 240 dpm/cm2 for beta-gamma emitters. Removable contamination level on the bottom surface of the package, indicated a removable contamination level of around 413 dpm/cm2 as compared to the regulatory limit of 240 dpm/cm2 for beta-gamma emitters. The package contained three unit doses consisting of a 6 mCi dose of Tc-99m Mebrofenin (calibrated for 1330), a 25 mCi dose of Tc-99m Sestamibi (calibrated for 0930), and a 1 mCi dose of Tc-99m Sulfur Colloid (calibrated for 0800). The dosage was shipped from Triad Isotopes, out of Jacksonville, Florida, who was also the delivery carrier. The facility Radiation Safety Officer immediately notified the delivery carrier by phone about the contaminated package around 0730 EST. The patient dosages inside the package were not impacted and were able to be used. As corrective actions, the packaging materials were bagged in plastic and set aside in a restricted area at the facility. VHA National Health Physics Program, who manages the master materials license, was notified of the incident around 0840 EST. In addition, the licensee is notifying their NRC Region III project manager (Parker) of the event by inclusion in this email. The external contamination was Tc-99m and the package will be held until the isotope has decayed prior to returning it to the pharmacy.
The following is a synopsis of information received via E-mail: Reporting Organization: State of Florida Bureau of Radiation Control NRC Notified By: Matthew Senison Licensee: Jubilant DraxImage Radiopharmacies, Inc. City, State: Jacksonville, Florida License Number: 4587-5 Jubilant, Jacksonville received a call from the VHA in Gainesville, Florida about a delivery bag which had been delivered around 0710 EST that was contaminated on the outside. Jubilant, Jacksonville then notified their RSO who notified Jubilant's corporate RSO. Jubilant, Jacksonville personnel reviewed surveys and DOT documentation and found no removable contamination. They immediately pulled all six carts that are used in the pharmacy and wipe tested and surveyed each cart using a single channel analyzer and found only background. The driver is a third party (MDS) and had just returned. Jubilant, Jacksonville personnel surveyed and wipe tested the entire van and found it to also be at background. The Jubilant, Jacksonville RSO then called the VHA's RSO to relay that three patient doses were in the bag and no removable contamination had been found in the bag nor on the doses. VHA's RSO stated that she was notifying the NRC who would notify BRC. Since the NRC report shows the activity was Tc-99m, and neither party could find the source; at this point greater than five half-lives have passed, so there are no current plans to deploy investigators to either facility at this time. Florida Incident Number: FL20-023 (2) Notified R1DO (Ferdas), R3DO (Orth), and the NMSS Events Notification E-mail group. |
| ENS 42523 | 24 April 2006 14:11:00 | The State provided the following information via email: On April 21, 2006, the Radioactive Materials Program of Arkansas Department of Health and Human Services was notified by Central Arkansas Radiation Therapy Institute, ARK-654-BP-12-08, located in Little Rock, of a possible misadministration (medical event), which had been identified during the post-implant CT of a prostate implant patient. Based upon the CT scan, the facility determined that the I-125 seeds had been implanted in the incorrect area. The post-implant treatment plan generated on April 24, 2006, indicated that a dose greater than 50 Rem had been delivered to an unintended area of tissue. The licensee and Department will continue to investigate this event. A final written report regarding this misadministration (medical event) will be submitted within 15 days. NRC Region IV was notified of the potential misadministration on April 21, 2006.
As previously reported, on April 21, 2006 CARTI notified Arkansas Department of Health and Human Services of a misadministration (medical event) that occurred during an I-125 prostate seed implant. The final written report was received on May 9, 2006. The post-implant dosimetry imaging determined that the 84, I-125 seeds with average activity of 0.219 mCi on March 28, 2006, were misplaced approximately 4 cm inferior to their intended position. The post-implant dose calculation determined that a dose of 108 Gy, which was consistent with the prescribed dose, had been delivered to the incorrect area. Root cause was determined to be two-fold. First was the inability prior to implant to place a Foley catheter to fill the bladder allowing a clear definition of the base of the prostate gland. Second was the human error in clear delineation of the prostate gland and alignment of the template prior to seed implant. The patient will require further treatment of the prostate gland via re-implantation in order to deliver the appropriate dose. Any effects from the misadministration (medical event) may not manifest immediately and may be difficult to distinguish from the effects of the external beam IMRT treatment that the patient received prior to the March 2006 implant. The licensee has implemented a new policy for inexperienced urologists that requires placement of the Foley catheter prior to implanting seeds, thus ensuring clear definition of the base of the prostate and the urethra. Notified R4DO(Powers) & NMSS EO(Morell) |