Event Notification Report for April 26, 2023

EN Revision Imported Date: 4/26/2023

EN Revision Text: MEDICAL EVENT - DOSE ABOVE THE PRESCRIBED DOSE

The following was received from the licensee via email:

"The VA National Health Physics Program is reporting a medical event as defined in 10 CFR 35.3045.

"The medical event occurred at the VA San Diego Healthcare System, San Diego, California. The Department of Veterans Affairs holds NRC license number 03-23853-01VA.

"The medical event occurred on July 13, 2021, and was discovered on November 16, 2021. The medical event involved the administration of approximately 152 millicuries of Iodine-131 sodium iodide to a patient. The patient received close to the activity intended by the authorized user physician. However, there was an error on the written directive form - the activity prescribed by the authorized user physician was mistakenly listed as 2 millicuries. Because the patient received the intended treatment, this medical event is not expected to cause any harm to the patient. The VA National Health Physics program has notified the NRC Project Manager for the VA Master Materials license."

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.


* * * RETRACTION FROM BOB BINGMAN TO THOMAS HERRITY AT 1616 EDT ON 04/25/2023 * * *

The following information was provided by the licensee via email:

"The VA National Health Physics Program is retracting an event that was previously reported as a possible medical event. It was reported to the NRC Operations Center on November 17, 2021, pursuant to 10 CFR 35.3045, NRC Event Number 55585.

"The event occurred at the VA San Diego Healthcare System, San Diego, California. The Department of Veterans Affairs holds NRC license number 03-23853-01VA. The event occurred on July 13, 2021. It was discovered on November 16, 2021. The event involved the administration of approximately 152 millicuries of iodine-131 sodium iodide to a patient. There was an error on a form labelled `written directive' - the activity prescribed by the authorized user physician was mistakenly listed as 2 millicuries. There was a second document: the patient medical order, which met the NRC criteria for a written directive, listed a prescribed dosage of 150 millicuries, was signed by the authorized user, and was used by the authorized user as the written directive.

"The basis for this retraction is, this was determined to be a paperwork error only; therefore, a medical event did not occur. Because the patient received the intended treatment, there was no harm to the patient. The facility has taken corrective actions to prevent a recurrence. The VA National Health Physics program has notified the NRC Project Manager for the VA Master Materials license of our plan to retract the event declaration."

Notified R3DO (Stoedter) and NMSS Events Notification (email).

AGREEMENT STATE REPORT - GENERATOR LOST IN SHIPMENT THEN FOUND

The following synopsis of information was provided by the Massachusetts Radiation Control Program (the Agency) via email:

At 1900 EDT on April 17, 2023, Lantheus Medical Imaging, Inc. (the Licensee) reported that at 1500 EDT on that day it had discovered a package containing a 15 Curie Mo-99/Tc-99m generator was not delivered to RLS in Van Nuys, CA (the intended recipient).

On April 18 at 1200 EDT, the Licensee learned that the package was still in the delivery truck in California. The driver had two deliveries to make on April 17, 2023, but only made one of the deliveries, leaving the package containing the generator in his vehicle overnight. Once the package was found, it was delivered to its intended recipient.

The reporting requirement is immediate per 105 CMR 120.281(A)(1), missing licensed radioactive materials in aggregate quantity equal to or greater than 1,000 times quantity specified in 105 CMR 120.297, Appendix C.

MA Number.: TBD

The Agency considers this event to be open.

THIS MATERIAL EVENT CONTAINS A 'Category 3' LEVEL OF RADIOACTIVE MATERIAL

Category 3 sources, if not safely managed or securely protected, could cause permanent injury to a person who handled them, or were otherwise in contact with them, for some hours. It could possibly - although it is unlikely - be fatal to be close to this amount of unshielded radioactive material for a period of days to weeks. These sources are typically used in practices such as fixed industrial gauges involving high activity sources (for example: level gauges, dredger gauges, conveyor gauges and spinning pipe gauges) and well logging. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

AGREEMENT STATE REPORT - LOSS OF CONTROL OF RADIOACTIVE MATERIALS

The following information was provided by the Wisconsin Radiation Protection Section (the Department) via email:

"On March 21, 2023, the licensee, PPD Development, LLC, reported a loss of control of radioactive material to the Department. On February 23, 2023, the licensee discovered that eight shipments were sent to a hazardous waste vendor in Nebraska for disposal, and the waste inadvertently contained carbon-14 radiolabeled pharmaceutical samples used for research and development. The eight shipments occurred between July 26, 2019, and October 27, 2022. In total the amount of carbon-14 that was improperly disposed of was 3.88 millicuries. The largest single shipment contained 1.19 millicuries of carbon-14. The licensee immediately contacted the recipient and determined that the waste had already been incinerated. The State of Nebraska has been notified. The Department performed a reactive inspection, and the investigation is ongoing."

WI Event Report ID No.: WI230005

* * * UPDATE ON 4/20/23 AT 1250 EDT FROM MEGAN SHOBER TO ADAM KOZIOL * * *

"On April 19, 2023, the Department became aware that of the eight referenced shipments inadvertently containing carbon-14, only four shipments were sent to a hazardous waste vendor in Nebraska. The other four shipments were sent to a hazardous waste vendor in Arkansas and incinerated. The State of Arkansas has been notified."

Notified R3DO (Orth), NMSS Events, and ILTAB

STUCK SOURCE WITH POTENTIAL OVEREXPOSURE AND MEDICAL UNDERDOSE

The following information was provided by the licensee via email:

"At about 1000 EDT on 4/19/23 the licensee was performing an HDR treatment on a patient's cervix using a Nucletron B.V 136149A02 model Flexitron HDR remote after loader containing a 12 Ci Ir-192 source. The applicator has three sections: right and left partial rings on either side of the cervical os, and a tandem inserted into the cervix. The intended dose was 500 centi-Gray (cGy) to points called Right A and Left A, 2 cm up and 2 cm out from the cervical os.

"Computed clinical dose to the patient was 156 cGy to the A points which is 31 percent of what was prescribed. The total dose for the four treatments is 1,656 cGy which is 83 percent of prescribed.

"The HDR unit functioned properly in treating the first section, the right ring. It then treated the left ring properly, but at the end of treatment it gave an error message, and the radiation monitors in the room and above the door indicated that the source did not return to the safe position. As a result, the treatment was shutdown, and emergency procedures instituted. The tandem was not treated.

"After several unsuccessful attempts to bring the source to the safe position, the applicator was removed from the patient, the patient was removed from the room, and the room was closed and sealed.

"Preliminary dose estimates received by personnel are as follows:

"Authorized User - 10,000 mrem
Medical Physicist - 10,000 mrem
Nurse Anesthetist - 700 mrem
Radiation Technician - 4,000 mrem
Radiation Technician - 700 mrem

"Badge dosimetry was collected and sent for processing to confirm actual doses received.

"Staff were successful in returning source to a safe condition, and a manufacturer representative will be conducting an inspection of the device before further use.

"No adverse effects anticipated to the patient from this event, and the shortfall in dose will be made up at a future date."

* * * UPDATE ON 04/21/23 AT 0930 EDT FROM KELLY STONEBERG TO KERBY SCALES * * *

The following update is a summary of information received from the licensee via email:

Initial dose estimates for the individuals who were present in the room while the HDR source was outside the HDR unit due to malfunction of the unit were conservatively estimated to be greater than the 5 rem reportable limit. The dosimeters were immediately sent out for processing after the event and the actual readings were below the reportable limit. The individual's readings were as follows:
Radiation Technician 1 - 87 mrem
Radiation Technician 2 - 2 mrem
AMP - 47 mrem

Notified R1DO (Arner), NMSS (Rivera-Capella) and NMSS Events Notification via email.

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.

EN Revision Imported Date: 4/26/2023

EN Revision Text: ITEM RELIED ON FOR SAFETY (IROFS) NOT ESTABLISHED

The following information was provided by the licensee via email:

"The plant is in a safe condition.

"On April 21, 2023, Urenco, USA (UUSA) was staging a construction crane to be used the following week and failed to maintain procedural compliance while implementing IROFS50f and IROFS50g. The crane was properly permitted and placed inside the Controlled Access Area but was not properly permitted for operation. At all times the required spotters for IROFS50f and IROFS50g were in place and the movement of the crane was sufficiently controlled to restrict its movement to not swing into an area where damage could occur. However, visual indicators (reference markers) were not established as required by procedure. Spotters were in place and exercised appropriate control.

"IROFS50f/g are independent, administrative IROFS that prevent heavy vehicles from damaging equipment that could result in a UF6 release. Both IROFS are required to meet the performance requirement of 10 CFR 70.61.

"Work has been stopped and the crane has been demobilized. UUSA is conservatively reporting this event under 10 CFR 70 Appendix A (a)(4)."

The licensee will notify Region 2.

* * * UPDATE ON 04/22/2022 AT 1501 EDT FROM JIM RICKMAN TO BILL GOTT* * *

"This issue has been entered into the corrective actions program as EV 160170.

"Following a more detailed review, IROFS50g was determined to be operable and adequately implemented. As a result, the appropriate reporting criteria is being changed to 10 CFR 70 Appendix A (b)(2)."

Notified R2DO (Miller) and NMSS Events Notification (email).

* * * UPDATE ON 04/25/2022 AT 1501 EDT FROM JIM RICKMAN TO THOMAS HERRITY * * *

"2nd Update:

"The operation of the crane has stopped and it remains south of Separation Building Module (SBM) 1001.

"Contrary to the initial report, the required spotters were not present and controlling the movement of the boom. As a result, IROFS50f/g have been determined not to be available and reliable. The appropriate reporting criteria is being changed to 10 CFR 70 Appendix A (a)(4).

"The stop work involving the use of construction vehicles and IROFS50 remains in place. All work performed by site projects has been stopped."

The licensee has notified Region 2.

Notified R2DO (Miller) and NMSS Events Notification (email).

AGREEMENT STATE REPORT - DAMAGED GAUGE

The following information was received from the South Carolina Department of Health and Environmental Control (the Department) via email:

"The Department was notified via telephone at 1511 EDT on 04/19/23, that during a routine inspection of the licensee's fixed gauging devices, the source window of one device was discovered to have been damaged. The licensee is reporting that the fixed gauge is a Thermo Fisher Model ASC-185 gauging device, housing a Kr-85 Isotope Products Laboratories Inc. sealed source Model NER-588 with an activity of 46.25 giga-becquerel (1250 millicuries). The licensee is reporting that no immediate health and safety concerns have been identified. The licensee is reporting that the manufacturer of the gauging device has been contacted for repair, and this repair was initiated upon discovery on 04/19/23. A Department inspector will be dispatched to the facility. This event is still under investigation by the Department."

SC Event Report ID No.: EN 56479

MEDICAL EVENT - PATIENT UNDERDOSE

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.

AGREEMENT STATE REPORT - LOST I-125 SEED

The following information was provided by the Arizona Department of Health Services (the Department) via email:

"On 4/20/2023, the Department was notified by the licensee of one missing I-125 radioactive seed for breast tumor localization. According to the licensee, one IsoAid Advantage I-125 breast localization seed (containing approximately 0.158 mCi of activity) was removed by surgery on 4/17/23 and was verified to be included in the specimen. The specimen with the seed was delivered to pathology on the afternoon of 4/17/23. The seed was removed from the specimen by pathology on 4/17/23. When nuclear medicine came to retrieve the seed, the jar was empty and the licensee was unsuccessful in locating the missing I-125 seed. The Department has requested additional information and continues to investigate the event.

"Additional information will be provided as it is received in accordance with SA-300."



THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

OFFSITE NOTIFICATION - SPILLED SODIUM HYPOCHLORITE

The following information was provided by the licensee via email:

"On 4/25/2023 at approximately 2315 [MST] it was reported that there was possible sodium hypochlorite actively leaking near the 'A' essential spray pond (ESP). Upon investigation, it was determined that the 'low flow' line of sodium hypochlorite supply to the 'A' spray pond had developed a leak. Sodium hypochlorite had pooled at the leak location and subsequently run down the ESP apron, into the road, and into the storm drain located in the protected area fence. An estimate of approximately 300 gallons of spilled sodium hypochlorite was determined based on the time frame that the sodium hypochlorite was scheduled to start injecting into the 'A' spray pond and the time the leak was isolated. The leak was isolated on 4/25/2023 at approximately 2330.

"The leak was contained in the storm drain with the storm gates closed, therefore nothing was released offsite. The cleanup effort in progress includes diluting the sodium hypochlorite with domestic service water, collecting it into the storm drain, pumping it to a tank truck, and transporting it to the Palo Verde Water Resources Facility for neutralization.

"Condition Report 23-04519 was generated to document the leak. The Palo Verde Senior Environmental Scientist was notified and subsequently informed the Environmental Protection Agency (EPA) National Response Center (NRC#1365638) on 4/26/23 at 0005 in accordance with the 91DP-0EN03 Environmental Spill Response [local procedure]. The NRC Senior Resident Inspector was also notified.

"No personnel were injured and no equipment was damaged as a result of the spill. The Palo Verde Fire Department was notified and the area was barricaded off to prevent personnel from entering the area during the cleanup effort.

TECHNICAL SPECIFICATION DIRECTED SHUTDOWN

The following information was provided by the licensee via email:

"Violation of Limiting Condition of Operation per Nuclear Science Center Reactor (NSCR) technical specifications (TS) 3.5.1. Report made in accordance with TS 6.7.2.

"At approximately 1300 [CDT], April 25, 2023, it was determined there was a Limiting Condition of Operation that required a remote display for a single Area Radiation Monitor (ARM) on the reactor bridge in the Emergency Support Center. That display had been inoperable for two weeks. The ARM was operable, and the displays in the reactor control room and on the reactor bridge at the ARM location were active. The remote display is located in a different building from the reactor confinement building.

"Upon discovery of the situation, the reactor was shut down. This notification to the [NRC] Headquarters Operations Officer is required by NSCR TS 6.7.2 within one working day.

"Corrective actions underway:

"The display of the ARM is being repaired and will be confirmed to be in operation prior to the restart of the NSCR, and for each successive start up."

FITNESS FOR DUTY REPORT

A non-licensed supervisor had a confirmed positive for alcohol during a random fitness-for-duty test. The employee's access to the plant has been terminated.

The NRC Resident Inspector has been notified.