Event Notification Report for July 07, 2022

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 - MEDICAL EVENT

The following was received from the Illinois Emergency Management Agency (the Agency) via email:

"Representatives of Elmhurst Hospital (RML IL-01612-01) contacted the Agency at approximately 1230 CDT today, 6/29/22, to report a Y-90 Theraspheres administration that took place on 6/29/22 (approximately 1000 CDT) which resulted in 100 percent of the dose prescribed not being delivered. The pre and post surveys of the vial and delivery system were nearly identical, supporting the licensee's assertion that no microspheres were delivered. The patient was surveyed post-administration and was at background. While contamination was identified on the draping, it resulted from the disconnection of the delivery system when the administration was halted. No contamination was identified on the patient.

"Microspheres were observed clustered at the hub and none beyond. The licensee claims there were no kinks and the manufacturer's checklist was followed to include agitation/flushing. At this time, it is unclear if the patient and referring physician have been notified, but the licensee is aware of the requirement. The licensee is aware of the 15-day written report requirement. The AU [(Authorized User)] will be back in the office on Friday and understands the Agency will need additional information via a reactionary inspection. The Agency is scheduling a reactive inspection and this report will be updated as information becomes available."

Illinois Item Number: IL220023

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 SHIPMENT

The following was received from the California Department of Public Health Radiologic Health Branch (CDPH/RHB ) via email:

"On 06-29-2022, Mistras Group determined that their shipment containing radioactive materials was officially declared lost. This is not a NSTS [(National Source Tracking System)] level source.

"The RSO [(Radiation Safety Officer)] for Mistras Group Inc. notified CDPH/RHB that a QSA source changer, QSA model 650L, No. 201 containing a QSA Global, Inc. iridium-192 source, model A424-9 No. 683G (radioactivity content on 06-29-2022 was 4.5 curies) shipped on 06-16-2022 had not arrived at QSA Global, Burlington, MA in a timely manner. The [Common Carrier] tracking number indicates the package arrived at the [Common Carrier] hub in Memphis, TN on 06-17-2022, but was delayed with an expected delivery on 06-22-2022.

"On 06-20-2022, QSA Global notified Mistras Group that only two of their three shipments had been received.

"On 06-22-2022, the [Common Carrier] reported the package remained delayed.

"On 06-25-2022, a missing Dangerous Goods (DG) investigation was opened to trace the package. DG was provided a picture of the missing package.

"On 06-27-2022, the [Common Carrier] administrator notified Mistras Group that the package was not located in the hub of the [Common Carrier], Memphis, TN.

"On 6-28-2022, the [Common Carrier] DG personnel notified Mistras Group that the package was not found at LAX [(Los Angeles International Airport)]."

California 5010 Number: 062922

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