Event Notification Report for January 26, 2024

EN Revision Imported Date: 1/26/2024

EN Revision Text: FALSE NEGATIVE AND POSITIVE ON BLIND PERFORMANCE SAMPLE

The following information was provided by the licensee via email:

"On November 2, 2023, at 0715 CDT, it was discovered that the results of a blind performance specimen provided to a Health & Human Services (HHS)-certified testing facility were not as expected. The blind specimen results indicated a false negative for MDA/MDMA and a false positive for amphetamines.

"Investigation is ongoing to determine if the results are accurate.

"This report is being made in accordance with 10 CFR 26.719(c)(2) and 10 CFR 26.719(c)(3).

"The NRC Resident Inspector has been notified by the licensee."

* * * RETRACTION ON 1/25/24 AT 1139 EST FROM REX GUNDERSON TO THOMAS HERRITY * * *

"Follow-up investigation by an independent Health and Human Services laboratory confirmed that the blind specimen in question was analyzed correctly. The error is thought to have occurred during the preparation of the blind specimen, prior to delivery to the site.

"The NRC Resident Inspector has been notified by the licensee."

Notified R3DO (Orlikowski) and FFD Group (email).

EN Revision Imported Date: 1/25/2024

EN Revision Text: AGREEMENT STATE REPORT - POTENTIAL OVEREXPOSURE

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

"On Thursday, January 11, 2024, the Agency received written notification from the radiation safety officer (RSO) at a nuclear pharmacy of an elevated dosimetry badge report for a worker in Romeoville, IL. The whole body dose reported would exceed the occupational limits in 32 Ill. Adm. Code 340.210. The information provided indicates the worker received 162,926 mrem during the week of December 11, 2023, which exceeds the annual limit of 5,000 mrem. This is a reportable incident under 32 Ill. Adm. Code 340.1230, and will be reported to NRC and NMED. While an investigation is underway to determine the cause of this overexposure, after speaking with the RSO, it is likely the result of a spill/splash event. If this spill resulted in an occupational exposure in excess of the limits, it is also reportable under 32 Ill. Adm. Code 340.1220(b) and will be reported to the NRC today. In the next week, Agency inspectors will perform a reactionary inspection to inspect the adequacy of the licensee's investigation, compliance with the Agency's regulations, and determine the root cause."

NMED Item Number: IL240002

* * * UPDATE ON 1/24/2024 AT 1557 EST FROM GARY FORSEE TO KAREN COTTON * * *

"A reactive inspection was conducted on 1/19/24. Reportedly on 12/11/2023, the technician noted a pressure issue within an F-18 synthesis cell. While containing approximately 9.9 Ci of F-18, the technician opened the synthesis cell to diagnose the issue. The magnitude of the resulting whole-body exposure is an unknown component of the reported 162 rem. Extremity badges reported only 447 mrem for this wear period. Movement of the synthesis tubing resulted in an undetermined quantity of F-18 contaminating the upper chest, neck and underarm of the technician.

"The technician reports feeling `wetness' as a result of the contamination event. Licensee staff estimated 3-5 minutes passed before decontamination efforts were initiated. Initial survey readings on the technician were 12 mR/hour from the neck and chest after shirt and lab coat were removed. No assessment of uptake/intake was performed, nor were any bioassays performed. No medical assessment was performed for blood changes or impacts to the skin. The corporate Radiation Safety Officer (RSO) was not notified until the dosimetry report was returned nearly 30 days later. At the time of the inspection, no medical conditions had emerged that were indicative of radiation exposure. The technician's badge was not evaluated for contamination, simply assumed to be contaminated and sent for reading. The badge did not show evidence of contamination when received by the dosimetry processor - however, that may have been due to decay.

"The licensee did not cease or limit any work with radioactive materials assigned to the individual. The employee has continued work in 2024, as the elevated exposure was attributed to the 2023 annual limit. Inspectors believe there is some portion of the exposure recorded on the optically stimulated luminescence (OSL) [dosimeter] that was not a true whole-body exposure (resulting from contamination and storage in the bunker). However, the lack of adequate records or timely assessment makes any quantification impossible. While an undetermined fraction of the recorded 162 rem was likely not a whole-body dose to the technician; there are certainly exposure avenues which could have led to at least 5 rem whole body. Until data is presented which indicates otherwise, this matter is being treated as an occupational exposure in excess of the 5 rem limit. While 16 mL containing 9.9 Ci of F-18 was in the synthesis cell, there is no accurate account on the amount of activity deposited on the technician's skin/clothing. (The syringe containing the F-18 was not used and allowed to decay within the cell. No volume or activity assessment performed). The only data allowing an estimate is the initial 12 mR/hour exposure rate, which would be close to 13 microcuries of activity incident to the detector active surface area. I.e., if the badge was surveying 12 mR/hour at one inch, that would equate to approximately 13 microcuries of F-18 incident to the probe. The exposure to the OSL over the mean life of this F-18 is estimated at 20 Rem.

"No data is available to estimate committed dose. While a VARSKIN+ analysis is pending, initial estimates indicate skin dose is likely less than 10 percent of the occupational limit. If the entirety of the 162-rem exposure was suspected to have come from contamination, the initial contamination of the badge would have needed to exceed 100 microcuries. This would have an exposure rate in excess of 100 mR/hour - inconsistent with the recorded exposure rates. Occupational whole body dose year to date, prior to this incident, was recorded at 974 mrem. Average weekly whole-body dose was 19 mrem.

"The area was isolated due to the spill and this incident is likely also reportable under 32 Ill. Adm. Code 340.1220(b), equivalent to 10 CFR 20.2202(b). The investigation is still in process."

Notified R3DO (Orlikowski), NMSS Event Notifications (Email), and NMSS/MSST Division Director (Williams)

AGREEMENT STATE REPORT - LOST SOURCE

The following report in part was received via email from the Maine Radiological Control Program [MRCP]:

"The licensee service manager contacted MRCP by phone on December 22, 2023, to report that a source could not be accounted for during a monthly source inventory. The service manager reported that the missing source had been observed in the service area of the licensee's facility in Windsor, ME, approximately two weeks before the inventory identified it as missing. The missing source had been removed from a customer's machine and replaced with a new source. The missing source is an 8 mCi Ni-63 source with serial number 09-6700 from Isotope Products Laboratories, Valencia, CA. The source was still in its sealed form inside the detector housing which is assembled with tamper-proof screws. Once the source was determined unaccounted for in the monthly inventory, a team of licensee employees searched the entire facility, spending in excess of 20 man-hours trying to locate it. The licensee's best assumption is that the missing source may have been accidentally disposed of during a recent shop cleaning. MRCP conducted a site inspection on January 2, 2024, to gather information regarding the incident. A licensee service technician was able to trace the waste stream which is routinely deposited in a dumpster and is then transported to the Waterville, ME, transfer station. As of January 19, 2024, the missing Ni-63 source remains lost."

Maine Event Report Number: ME 2023-002

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

EN Revision Imported Date: 1/29/2024

EN Revision Text: AGREEMENT STATE REPORT - STUCK SOURCE RACK

The following information was received from the Illinois Emergency Management Agency (IEMA-OHS) via email:

"The IEMA-OHS Operations Center was contacted at 1712 CDT on December 17, 2023, by the radiation safety officer for Sterigenics to report a stuck source rack. The rack reportedly became stuck around 2300 on December 16, 2023, with approximately 10 percent of the sources above the pool level. The area was isolated with an additional restricted area established to maintain occupational exposures within limits. At this time, no public or occupational exposures above regulatory limits have been reported. This matter has a 24-hour reporting requirement under 32 Ill. Adm. Code 346.830 which was met by the licensee. IEMA-OHS inspectors will arrive at the facility on 12/18 to evaluate timelines for corrective action and the efficacy of safety systems. Staff will also evaluate the site and review staff dosimetry, potential impacts to source capsule integrity, any anticipated heat impacts, and plans for quality assurance of the impacted system(s)."

Source type: sealed source irradiator
Radionuclide: Co-60
Activity: 24 MCi (888 PBq)
Model no.: C-188

Illinois report no.: IL230036

* * * UPDATE ON 12/19/23 FROM WHITNEY COX TO DAN LIVERMORE * * *

The following information was received from the Illinois Emergency Management Agency (IEMA-OHS) via email:

"Agency staff arrived at the site on 12/18/23 and surveys indicate no public or occupational exposure levels above normal operation. The source rack is still stuck in the unshielded position. The Agency continues to monitor the situation and will update when additional information is available."

Notified R3DO (Edwards), NMSS (via email).

* * * UPDATE ON 1/4/24 FROM GARY FORSEE TO IAN HOWARD * * *

The following information was received from the Illinois Emergency Management Agency (IEMA-OHS) via email:

"The Licensee reports 18 modules (3 rows), constituting 626,000 curies of Co-60, in the B/C cell remain stuck in the unshielded position due to product carts impeding travel of the rack. The sources are below the point of product cart impact. A second IEMA-OHS inspection was conducted to increase coordination on response activities and obtain additional data on the following: security requirements (all operational), radiation levels (700 microR/hour maximum reading), dosimetry procedures (transitioned to digital dosimetry which is read daily and employed at a 40 mrem/day investigational level), total occupational doses to date (20 mrem), exposure rate maps including access points used for radiation hardened cameras, personnel access, pool conductivity (within specifications), updated operations and emergency procedures (confirmed), on site staff and safety culture (satisfactory, additional manufacturer health physics staff brought in to assist), fire hazards (none at this time), status of deionizer (satisfactory), and mitigation planning.

"The Licensee is awaiting cameras and remote vehicles capable of withstanding radiation levels and manipulating product totes. The facility was confirmed to be in a safe and stable condition and ongoing response operations will be coordinated with IEMA-OHS. IEMA-OHS has now transitioned to weekly inspections until the incident is remedied.

"Updates will be provided as they become available."

Notified R3DO (Stoedter), NMSS (via email).

* * * UPDATE ON 01/26/24 FROM GARY FORSEE TO THOMAS HERRITY * * *

The following information was received from the Illinois Emergency Management Agency (IEMA-OHS) via email:

"The source rack was successfully returned to the shielded position. Sterigenics staff employed engineered tooling to access the stuck rack through roof projections on the evening of 1/25/24. IEMA-OHS staff were on site to observe setup and operations throughout the week. A review of digital dosimetry in use for all phases of the operations indicates there were no occupational exposures in excess of regulatory limits.

"Full report and root cause analysis pending. This report will be updated."

Notified R3DO (Orlikowski), NMSS (via email).

EN Revision Imported Date: 2/1/2024

EN Revision Text: AGREEMENT STATE REPORT - Y-90 MICROSPHERE MISADMINISTRATION

The following is a summary of information received via email from the Washington Office of Radiation Protection:

On the afternoon of Friday, January 19th, a Pluvicto (radiopharmaceutical) dose was not administered properly. A typical administered dose may have up to 2 to 4 mCi of residual activity after a 200 mCi administration. However, for this administration there was 43 mCi of residual activity and only 149 mCi of calculated administered activity for a 200 mCi prescribed dose. Pluvicto is a six fraction, six administration regimen with about six weeks between each administration, and this was the patient's fourth fractional dose. Treated as a single administration treatment, this constitutes a medical event as the dose administered activity of 149 mCi is more than 20% less than the 200 mCi prescribed dose. The final report will be sent in 15 days.

Washington Event Number: WA-24-003

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 1/29/2024 AT 1401 EST FROM BORIS TSENOV TO NATALIE STARFISH * * *
The following information is a synopsis of information provided by the Washington State Radioactive Materials Section:

A lutetium 177 (drug name: Pluvicto) dose was prescribed to be 200 mCi. The calculated dose administered to the patient was about 149 mCi, based upon the measured residual. The underdosing occurred due to a method of folding and crimping the intravenous tube with a hemostat and gauze instead of utilizing the kit provided clamp. The hospital supply chain of the intravenous kit was recently changed and the needed clamp was thought to be missing. To prevent future crimping of the intravenous tube, the use of hemostat and gauze will no longer be used.

This dose was the fourth dose of six prescribed to the patient, with six weeks between each administration. There is no expected change in the patient's treatment or prognosis based on the underdosing of the fourth fraction of six and no additional actions are required.

Final report will be sent in 15 days.

Washington Event Number: WA-24-003

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.

Notified R4DO (Agrawal) and NMSS (email).

AUTOMATIC REACTOR TRIP

The following information was provided by the licensee via email:

"At 2141 EDT, with Unit 2 in Mode 1 at 100 percent power, the reactor automatically tripped due to a main turbine trip. The trip was not complex, with all systems responding normally post-trip.

"Operations responded and stabilized the plant. Decay heat is being removed using the auxiliary feedwater and steam dump systems. Unit 1 is not affected.

"Due to the reactor protection system actuation while critical, this event is being reported as a four-hour, non-emergency notification per 10 CFR 50.72(b)(2)(iv)(B). The expected actuation of the auxiliary feedwater system (an engineered safety feature) is being reported as an eight hour report under 10 CFR 50.72(b)(3)(iv)(A).

"There was no impact on the health and safety of the public or plant personnel. The NRC Resident Inspector has been notified.

"All control rods are fully inserted. The cause of the turbine trip is being investigated."

The licensee notified the NRC Resident Inspector.