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).