Event Notification Report for April 29, 2021

EN Revision Imported Date: 4/29/2021

EN Revision Text: AGREEMENT STATE REPORT - PATIENT UNDERDOSE

The following information was received from the Washington State Department of Health:

"University of Washington broad scope license C001 reported a medical event. The event involves Y-90 microspheres contained in two vials of different activity. Vial A and Vial B were to be delivered to different treatment sites. However, the vials were mixed up and the lower activity vial was delivered to the wrong site, the Authorized User (AU) realized it was the wrong vial and did not inject the second vial. This resulted in an underdose of more than 20 percent. A full report is expected in 15 days and will be forwarded."

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 04/28/2021 AT 1321 EDT FROM TRISTAN DAY TO BRIAN P. SMITH * * *

The following update is from the report received via e-mail from the Washington State Department of Health:

"On Friday April 9, 2021, a patient had been prescribed two dosages of yttrium-90 microspheres intended for two different liver treatment sites. One treatment dosage was a larger amount than the other, 35.9 mCi and 21.4 mCi. Both dosages were measured in the Nuclear Medicine CRC 15R dose calibrator prior to use. They were found to be the correctly prescribed amounts and the vials were labelled correctly. Both dosages were transported to the Interventional Radiology suite. When the authorized user (AU) called for the first dosage, the higher of the two activities (35.9 mCi), it was set up and administered, including the required radiation dose rate measurement taken prior to and during the dosing. When the AU called for the second dosage (21.4 mCi), he noticed that the radiation dose rate measurement of the second dosage was higher than it had read for the first administration, which was supposed to be the larger of the two dosages. Realizing that the smaller of the two dosages was mistakenly administered first, the physician stopped the treatment and did not administer the second dosage. It was then confirmed that the patient received the lower of the two dosages (21.4 mCi) to the treatment site that was supposed to receive the higher dosage (35.9 mCi). Nuclear Medicine informed the Environmental Health and Safety Department's (EHS) Medical Health Physicist (MHP), and the MHP subsequently informed the Radiation Safety Officer (RSO).

"Initially, there were questions regarding the need to evaluate this event as a possible Medical Event. There was uncertainty regarding applying the medical event criteria to both sites together or to each individual site. Additionally, the first treatment site was under-dosed and the AU subsequently had determined that the dose delivered was adequate for that site.

"After discussing the event with the MHP on Monday morning, April 12, 2021, the RSO requested a meeting with Department of Health (DOH) to discuss the event. The MHP and RSO discussed the event with DOH that afternoon, and DOH informed that it would depend if the written directive included both sites, or if there was a written directive for each site.

"On Tuesday, April 13, 2021, all the required information was obtained, and the MHP and RSO reviewed the dosage and dose calculations and determined that the medical event criteria was met. The dose delivered is less than prescribed, and will result in no harm to the patient and it is the intention of the physician to treat the second site at some future time."

Washington Event Report Number: WA-21-006

Notified R4DO (Proulx) and NMSS Events Notification via email.

AGREEMENT STATE REPORT - DAMAGED MOISTURE DENSITY GAUGE

The following information was received from the Alabama Department of Public Health Office of Radiation Control via email:

"On April 20, 2021 about 1130 [EDT], Alabama licensee Building and Earth Sciences, Inc. (license number 1266) called to report that a moisture density gauge had been run over by a compactor while at a temporary job site. The licensee's representative stated that the gauge was in several pieces, and the source rod/probe could not be retracted into the safe shielded position. The licensee collected a leak test once the gauge was safely stored; exposure measurements from the leak test envelope were less than or equal to background. The gauge is a Troxler 3430 s/n 32716, with 9 milliCuries Cs-137 and 44 milliCuries Am-241:Be. The Agency is waiting on the licensee's report of this matter. More information to follow."

Alabama Report No.: 21-12

AGREEMENT STATE REPORT - STATIC ELIMINATOR LOST IN SHIPPING

The following information was received from the Minnesota Department of Health via E-mail:

"On 4/15/2021, 3M Company received three of four boxes containing radioactive material shipped from NRD, LLC, in Grand Island, NY. The fourth package, containing one NRD model P-2042 static eliminator with an activity of 5 milliCuries of Po-210, was not received with the other three.

"3M contacted NRD and the common carrier to inquire about the status of the missing package. The common carrier's website indicates that the package in question is still in shipment. The common carrier initially stated that they believed the package was delivered on 4/15/2021 with the other packages in the shipment.

"When the package did not arrive on 4/15/2021, 3M started looking for the missing package in case it actually had been delivered and misplaced on the shipping dock, but the package has not been located. 3M has requested that a formal investigation be performed by the common carrier. The investigation is ongoing at the time of this notification."

* * * UPDATE ON 4/21/21 AT 1443 EDT FROM TYLER KRUSE TO DONALD NORWOOD * * *

The following information was received via from the Minnesota Department of Health via E-mail:

"Minnesota Department of Health was informed by the licensee that the source has been recovered. It was at the licensee's facility and had arrived in a mislabeled package from the manufacturer."

State Event Report ID No.: MN-21-0002

Notified R3DO (Peterson), ILTAB, NMSS Events Notification, and CNSC (Canada) via email.

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: 4/30/2021

EN Revision Text: AGREEMENT STATE REPORT - UNREGISTERED GAUGES FOUND THEN ONE LOST

The following is a summary of a phone call from the state of Nevada:

A plant manager for the HC Companies Inc. was performing a walkthrough when three NDC-102 thickness gauges were discovered. The manager was familiar with the gauges from a different site, but this site did not have any registered, nor does this site have a license for any material. The gauges, potentially only requiring a general license, were moved and the corporate safety group notified in order to secure them. When the safety group arrived, one of the gauges was missing (s/n: 2690; source: 150 mCi of Am-241).

Item Number: NV210004

* * * UPDATE ON 4/23/2021 AT 1720 EDT FROM COREY CREVELING TO THOMAS KENDZIA * * *
The state of Nevada sent a picture of the missing source via email:

The picture confirms the the previous information and the date of the radiological strength was 1/92.

Notified: R4DO (Azua) (email), NMSS Event Notifications (email), and ILTAB (email).

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: 4/29/2021

EN Revision Text: LOST THEN FOUND SOURCE MATERIAL

The following is a summary of information received from the U.S. Navy via phone and email:

On March 5, 2021, the it was discovered that IBIS units (400 micro Ci total) had not been properly removed from 4 helicopter blades that were sent for recycling. The IBIS units were discovered when the detectors alarmed at the recycling facility in Bedford, IN. The blades were redirected to the Army Joint Munitions Command Morris Consolidation facility in Rock Island, IL for proper disposal.

Based on the shipping paperwork, the helicopter blades that contained the four IBIS were received at the recycling facility on 11/17/2020, and were picked up from the facility on 3/16/2021.

The highest reading was 0.7 mR/hr on contact without the cover installed for one blade. For the 3 other blades in their casing, needle deflection was observed, but had no appreciable dose rate.

It is not likely that personnel spent an appreciable amount of time in the vicinity of the helicopter blades.

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

* * * UPDATE ON APRIL 28, 2021 AT 14:27 FROM ANTHONY WILLIAMS TO THOMAS HERRITY * * *

Additional investigation has shown that the IBIS (Sr-90) sources were 500 microCuries each for a total of 2,000 microCuries sent to the recycling center.

Notified R1DO (Schroeder), ILTAB and NMSS via email.

EN Revision Imported Date: 4/30/2021

EN Revision Text: AGREEMENT STATE - PATIENT UNDERDOSE

The following report was received via e-mail from the California Department of Public Health - Radiation Health Branch [CDPH-RHB]:

"On March 13, 2020, the licensee radiation safety officer (RSO) contacted CDPH-RHB to report a medical event which occurred on March 11, 2020, and was discovered on March 13, 2020. The licensee reported that a patient was prescribed 200 mCi of I-131 NaI for the treatment of thyroid cancer, but received only 60 mCi on the day of therapy (March 11, 2020). The 200 mCi dose was divided into two capsules and the patient was unintentionally only provided one of the two capsules in a medicine cup by the authorized user. The second capsule was reportedly stuck in the shipping vial which the authorized user thought he had emptied. The 140 mCi I-131 capsule was returned to the radiopharmacy in the shipping vial and pig. This error was discovered when the radiopharmacy contacted the licensee on March 13, 2020 to inform them of the capsule's presence in the returned vial. The Medical Director of Nuclear Medicine was immediately notified, who in turn, notified the RSO. The referring physician was also notified on March 13, 2020 and took responsibility for notifying the patient. A subsequent dosage was administered to complete the therapeutic treatment.

"This medical event was initially reported to CDPH-RHB by telephone on March 13, 2020 and by written report dated March 27, 2020. However, CDPH-RHB does not believe that the medical event was reported to the NRC at that time. A recent inspection by CDPH-RHB brought this medical event to their current attention."

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: 4/30/2021

EN Revision Text: AGREEMENT STATE REPORT - LOST RADIOLOGICAL DEVICE
The following was received by email from the state of Florida:

"On March 26, 2021, a Co-57 reference vial was left by NMT (Advent Health) with ammo cases in the hotlab for pickup by Jubiliant pharmacy. On March 29, 2021, NMT noted the vial was gone, and later inquired of Jubiliant for transfer paperwork. Jubiliant denied picking up the source. Advent Health has conducted a thorough investigation and search for source and has contacted Jubiliant several more times and have not found the source. Source calibration certificate 07-21-2017, 5.51 mCi [Mfg - Benchmark, Model BM06E, serial # BM06057E17200109]. Jubiliant manager [was contacted]. Advent Health will send in a written report."

Florida Incident Number: FL21-048

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: 4/30/2021

EN Revision Text: UNDER DOSE DELIVERED DURING MEDICAL TREATMENT

The Radiation Safety Officer for the Saint Louis University Hospital called in and emailed the following notification:

"At approximately 1220 CDT on April 23, 2021, Y-90 SIR-Sphere was being administered to a patient. The prescribed dose [for the liver] was 43.2 mCi, the measured dose to be administered was 46.7 mCi, but due to a clog in the catheter, only a calculated 4.53 mCi dose was administered to the patient. Because this exceeds +/- 20 percent of the intended dose, we determined a medical event had occurred. There was no harm to the patient, and a follow-up dose is planned for Monday, April 26, 2021.

"Preliminary Determination of Cause: The cause of the medical event was believed to be clogging of the catheter, but the exact reason for the resistance was undetermined. When the resistance was encountered, the procedure was stopped by the administering physician, with the intention of terminating the procedure, resulting in an administered dose variance greater than +/- 20 percent of the prescribed dose, and thus determined to be a medical event.

"Additional Details:
 The Nuclear Medicine Technologist drew the dose per standard operating procedure. The procedure checklist was read and the dose administration set up was normal. All steps to prevent clumping of microspheres were followed.
 During the administration, the dose was agitated and attempted to be delivered. There was resistance on the plunger during the administration. The physician stated that the catheter was clogged. The procedure was stopped, with the intention to terminate the procedure, and to administer a second dose at a later time.
 The physician disconnected the A-line from the patient catheter. This caused the backpressure to expel the beads onto the administration table and the floor covering. The disposable covering of these surfaces were collected and disposed of in radioactive waste. The Interventional Radiology Suite was surveyed and released, with all wipe tests and G-M survey meter readings at background."

Licensee notified R3 NRC Inspector (O'DOWD)

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: 4/30/2021

EN Revision Text: PART 21 - FAILURE OF SIZE 1 AND 2 FREEDOM SERIES FULL VOLTAGE REVERSING STARTERS

The following is a summary of information received from Paragon Energy Solutions:

On 3/29/2021, Dominion - North Anna Station has identified instances where size 1 and 2 starters have failed to function as expected in assemblies that were originally supplied by Nuclear Logistics LLC (NLI). The mechanical interlock exhibited binding that prevented the contactor from closing when energized. The identified failed starters are utilized in an application of operating Motor Operated Valves (MOV). This is an intermittent duty application.


The issue was identified on Eaton Starter Model AN56DN*, AN56GN*, CN55DN*, CN55GN* style starters and contactors with supplied date codes T4514 (week 45 of year 2014) and T4215 (week 42 of year 2015). Paragon is in the process of identifying the date codes to provide the specific information to the identified plants.

The following plants were supplied starters from September 2014 through October 2018: Beaver Valley, Columbia, Ergytech, Harris, Millstone, NEK KRSKO, North Anna, Prairie Island.

The component design that exhibited the failure was revised by the original equipment manufacturer (Eaton) in October 2018. There have been no reported failures of the interlock mechanism in vintages manufactured before September 2014 or after October 2018.

These recommendations are based on the specific application: The reversing starters and reversing contactors are typically wired in a configuration that will electrically lock out one of the contactors when the other one is being energized to prevent both contactors from being energized at the same time. Therefore, the mechanical interlock is not required to prevent both contactors from being closed at the same time when the electrical interlock configuration is being implemented. In this scenario, the mechanical interlocks are not required and can be removed.

The motor control centers that contain the mechanical interlock should be monitored to ensure that there is no binding during operation.

The evaluation being performed by Paragon is expected to be completed by May 29, 2021.

Tracy Bolt
Chief Nuclear Officer, CNO
817-284-0077
Paragon Energy Solutions, LLC
7410 Pebble Drive
Ft. Worth, TX 76118