Event Notification Report for June 29, 2022

EN Revision Imported Date: 9/2/2022

EN Revision Text: 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

* * * UPDATE ON 9/01/2022 AT 1616 EDT FROM LLINOIS EMERGENCY MANAGEMENT AGENCY TO KAREN COTTON VIA E-MAIL* * *
"The Agency conducted a reactive inspection on 7/1/22. At that time, no indications of root cause could be identified. The licensee's written report was received timely and presented no new information. The delivery kit was returned to the manufacturer for assessment when decayed.

"Subsequent information was submitted to the Agency for review. The licensee's written report was received timely. Documentation included Gamma camera images of the administration set up kit and catheter which appeared to show activity in the microcatheter. Based on images reviewed, the Agency cannot rule out that some activity may have been delivered to the patient.

"Due to the contamination, not all of the activity in the waste was able to be accounted for; however, the bulk of activity in the waste indicated that conservatively less than 8.9% of the dosage was delivered.

"Agency inspectors determined the potential root cause as clumping of microspheres between the D and E lines of the administration kit pending investigation/assessment of the administration kit by the manufacturer. The Agency will continue to monitor additional information provided by the licensee.

"This matter may be considered closed."

Notified R3DO (Hills) and NMSS Event 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

AGREEMENT STATE REPORT - POTENTIAL HIGH DOSE TO OTHER THAN TREATMENT SITE

The following was received from the state of Oregon via email:

"On June 29, a deviation on the length of the transfer tube was identified where the tube was found to be 2.9 centimeters longer than the vendor's specification (122.9 cm vs. 120 cm). This tube is used specifically with Channel 1 of the afterloader [(source: 10 Ci Ir-192; model: VS2000; s/n: 02-01-0235-001-031622-11038-12)] with a tandem and ring (T and R) applicator. Treatments therefore will be 2.9 centimeters shorter than the programmed distance for treatments and involving 1.5-2 cm of unintended tissue which shall exceed 50 rem and quite probably 50 percent to the location. The transfer tube length was last measured on July 27, 2020 and the licensee noted that the tube "measured length appeared to reflect the specified length by the manufacturer at the time." Because of this, the licensee believes they may have under-dosed some of their T and R patients using this transfer tube with Channel 1 of the afterloader. The licensee has already indicated two T and R treatments where this may be the case, May 13 and June 22, and is putting together a list of all cases since the most recent tube length verification in 2020.

Oregon Report ID Number: 22-0031

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 SOURCES

The following information was provided by the Illinois Emergency Management Agency (Agency) via email:

"The Agency received a report from the licensee on 7/16/22, indicating the potential loss of (4) brachytherapy seeds, accounting for a maximum estimated activity of 1.02 mCi. The licensee has conducted an investigation and believes the seeds were likely lost or miscounted during patient implant and prior to shipment from a medical facility. Requests for clarification and the nuclide (either I-125 or Pd-103) have not yet been returned. The amount and form of radioactivity would not be useful for illicit intent and there is no indication of intentional theft or diversion.

"DETAILS: On June 29th, 2022, the licensee received a package from a hospital in California (CA). The package contained a source that was outside of the primary container but was found in the corner of the shipping box. The shipping box, reportedly, appeared undamaged from the outside, but the inside lacked appropriate packing materials to cushion the pewter containers. This package was then opened, and all the sources were counted. The hospital sent return fax paperwork saying that the package had six containers from different orders with a total of 218 sources. After fully disassembling all sources from their cartridges, the licensee's staff counted 214 sources. This count at 214 was reverified multiple times by multiple associates. Surveys were also conducted of the licensee's receiving area and returns processing area, as well as, the path in between to verify that the unaccounted-for sources were not in the facility. The hospital staff was contacted to verify the number of sources returned. They responded confirming their records showed they returned 218 sources from six orders but explained that the returned items were packed by other associates prior to their involvement and did not reopen the containers to recount the sources during the shipping process.

"REPORTABILITY: At this time the [4 missing] seeds cannot be attributed to implant, loss in shipment or loss at the CA facility; and is therefore being reported as lost under 32 Ill. Adm. Code 340.1210. It is unclear if the licensee met the reporting window since we are awaiting information on the nuclides involved. The Agency is making notification within 24 hours of becoming aware of the report (email wasn't retrieved until 7/21/22, due to staff absence and the automated reply was not heeded by the notifying party).

"Additional information will be provided as it becomes available."

Illinois Event Number: IL220026

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