Event Notification Report for June 14, 2022

AGREEMENT STATE REPORT - HDR AFTERLOADER MOTOR FAILURE RESULTS IN ABORTED TREATMENT

The following information was received via E-mail:

"The following is preliminary information, and will be updated as the State of Washington learns more about this event:

"A mechanical incident occurred with the HDR (high dose rate) afterloader unit, and a treatment had to be aborted. It appears that a motor in the afterloader failed. The manufacturer's representative removed the active and dummy wires and is in the process of making the necessary repairs. There does not appear to be any radioactive material contamination in the system. No staff or patients received any excess dose. Plans are to exchange the source and complete all of the needed QA checks so that patient treatments may resume.

"The equipment involved was a Varian HDR remote afterloader, Model VariSource iX, Serial Number 600501, containing less than 11 curies of Iridium-192."

Washington Incident Number: WA-22-016

EN Revision Imported Date: 7/7/2022

EN Revision Text: AGREEMENT STATE REPORT - DOSE MISADMINISTRATION

The following information was received from the Minnesota Department of Health (MDH) via email:

"We (MDH) received an initial report on 6/15/22 at 1515 CDT of a reportable medical event. The event occurred at the University of Minnesota, license number 1049, in Minneapolis on 6/14/22. The event involved a treatment with Y-90 SirSpheres where 2.2 GBq was ordered but a 5.1 GBq unit dose was delivered and administered. The licensee is working through dose calculations. No additional details are available at this time. Follow up information will be sent when it becomes available."

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.

* * * UPDATE ON 7/6/22 AT 1013 EDT FROM SHERRIE FLAHERTY TO ERNIE WEST * * *

"The normal procedure for this therapy is to order a dose from the manufacturer a couple of weeks prior to the treatment so the radiopharmacy has the material on hand. The dosage ordered from the manufacturer is limited to few vial activities (want to make sure there will be enough for the therapy), and the actual dose to administer to the patient is drawn up by the pharmacy the day of the procedure. The pharmacy delivers the patient dose to the nuclear medicine department. Nuclear Medicine will check the activity compared to the shipping paper to make sure it is within range. They will also do the pre-measurements for determining the residual after the treatment. They will write the activity on the top of the Nalgene jar and bring it to interventional radiology. Interventional radiology will verify the dose on the lid and perform the administration. The residual is determined from the waste in the Nalgene jar per the standard microsphere procedure. The written directive is signed by the authorized user once the residual and actual dose given is determined.

"In the case on June 14, 2022, there was a communication error between the radiopharmacy (Jubilant) and the person ordering the dose. The pharmacy verified and the person who ordered the dose confirmed the dose was 5.6 GBq (the entire vial amount from the manufacturer). After drawing the dose, the activity in the vial the pharmacy sent was 5.1 GBq (they are not able to draw 100% of the material). Once received in nuclear medicine, the nuclear medicine technologist did their process, including comparing the dose in the vial with the shipping papers from the pharmacy (not the dose prescribed). The dose was brought to interventional radiology for the administration. The interventional radiologist did not see the activity on the Nalgene jar and was unaware that the activity was on the label. Without verifying the activity the interventional radiologist administered the dose. After the procedure the residual was calculated and it was determined that 5.1 GBq was administered (139 mCi prescribed and 137 mCi administered). The Authorized User signed the written directive after the procedure with the 139 mCi prescribed and 137 mCi administered activity. The prescribing physician (interventional radiologist) realized the error the next day when reading the post report.

"The State performed an on-site investigation and is pursuing enforcement actions. The event is still open. Minnesota will continue to keep NRC informed of the status of the investigation."

Notified R3DO (Lafranzo) and NMSS (Rivera-Cappella)

AGREEMENT STATE REPORT - LOST THEN FOUND I-125 SEED

The following information was received via E-mail:

"On 6/14/22, one Theragenics, I-125 brachytherapy seed (0.501 mCi) from the inventory was discovered missing. It was one of 10 spare seeds used for a patient prostate implant should they be needed. The inventory of concern was that required for a patient who was implanted with 88 seeds using 16 needles as planned. He did not need any of the spare seeds for his implant.

"In accord with our standard procedure, five of the 10 spare seeds were prepared in spare needles by one of our radiation oncology dosimetrists, one seed per needle, on Monday, 06/13/22. All prepared needles and loose seeds remained in the hot lab (SP 22244) until the patient's surgery. This means that five loose I-125 seeds should have remained in their transport vial in the hot lab (SP 2244) adjacent to the surgery room (SP 2245). However, when preparing to return the five spare needle prepared seeds to the transport vial, post patient implant, it was evident that there were only four rather than the expected five loose seeds in the vial. I surveyed the hot lab (SP 2244) but could not locate the missing seed in the hot lab or its surrounding area. The five spare needle prepared seeds were returned to the transport vial for a total of nine seeds rather than the inventory of 10. This vial was taken to the radiation oncology hot lab safe. Several surveys were performed of the Surgery Pavilion area (SP 2244) but the seed was not found.

"On 6/15/2022, the missing I-125 seed (0.501 mCi) was found and returned with the other loose seeds to the 'Medak' vial now located in the radiation oncology hot lab. On an inspired guess, the dosimetrist returned to the SP 2244 hot lab in the prostate pavilion and in a high cupboard searched a steel container used for sterilizing all 10 loose seeds before creating the five spare needles. This is where the missing seed was found.

"As corrective actions, the unused seeds will be visually counted and the checklist updated to include this process."

Washington Incident Number: WA-22-015

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

AGREEMENT STATE REPORT - UNABLE TO RETRACT SOURCE INTO RADIOGRAPHY EXPOSURE DEVICE

The following information was received by the Iowa Department of Public Health via e-mail:

"At 0229 CDT on 06-14-22, the Assistant RSO (ARSO) received a phone call from one of the radiographers involved stating that he was working at a temporary jobsite and was unable to fully expose the source into the guide tube/collimator (Device Model: QSA 880D, Source Model: QSA A424-9, Source Activity: 80.8 Ci). Upon noticing the resistance, the radiographer extended his Restricted Area boundaries, notified the on-site personnel to maintain clearance of the area and proceeded to contact the ARSO.

"During the phone conversation, the ARSO was able to guide the radiographer through disassembly of the crank body to the point that he could manually pull the drive cable and retract the source into a fully shielded position within the exposure device. Once the source was successfully locked into the exposure device and the appropriate surveys were completed, the ARSO instructed the radiographer to perform an inspection of the drive cables and guide tube to look for the presence of any bends, kinks or dents that could have contributed to the binding of the drive cable. It was at this point that the radiographer noted an area on the drive cable sheathing that appeared to be melted on the `retract' side of the drive cable assembly.

"At this point (approximately 0254 CDT), The ARSO contacted the PROtect, LLC RSO and informed him of the details of the incident. A follow-up Corrective Action Report and additional detail regarding the cause of the event will be submitted to the State of Iowa within 30 days.

"Reporting requirements:
30.50(b)(2)(ii) - The 24 hour report of an event where required equipment is disabled or fails to function as designed when the equipment is required to be available and operable when it is disabled or fails to function.
IAC 40.96(2)'c'(2)."

FITNESS-FOR-DUTY REPORT

The following information was provided by the licensee via email:

"A licensed operator supervisor had a confirmed positive for alcohol during a random fitness-for-duty test. The employee's access to the plant is on hold in accordance with the licensee's fitness-for-duty policy.

"The NRC Senior Resident Inspector has been notified."