Event Notification Report for June 07, 2022

EN Revision Imported Date: 6/13/2022

EN Revision Text: UF6 LEAKAGE INSIDE AUTOCLAVE

The following information was provided by the licensee via email:

"The plant is in a safe configuration. On June 3, 2022, isolated pressure fall (IPF) and isolated pressure rise (IPR) tests were completed satisfactory on manifold 1. A satisfactory Item Relied on For Safety [IROFS] surveillance was completed for manifold 1 and 1003 Autoclave was placed in service. On June 7, 2022 during the disconnect of 1003 Autoclave, an Operator noticed a white/yellowish film on the hex nut of the manifold and the upper portion of the cylinder valve. The Operator surveyed the film and found 4,000 to 6,000 dpm alpha and beta contamination. Prior to opening the door of 1003 Autoclave, the internal atmosphere was sampled for hydrogen fluoride (HF). No HF was detected by HF monitor. 1003 Autoclave has been taken out of service. Autoclave sampling manifold 1 has been isolated and IROFS 28 declared INOPERABLE."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
No employee exposures occurred. The leakage was contained inside the autoclave.

* * * RETRACTION ON 06/10/22 AT 1411 EDT FROM BARRY LOVE TO THOMAS HERRITY * * *

The following was provided by the licensee via email:

"The IROFS28 boundary, components, associated accident sequences and manifold leak were evaluated by Urenco-USA (UUSA) engineering. The evaluation determined that the leakage from the manifold did not result in IROFS28 being inoperable. IROFS28 was determined to be operable during this event.

"Based on this reevaluation, UUSA is retracting event notification EN 55930.

"UUSA will be notifying Region II."

Notified R2DO (Miller), and NMSS (Clark), NMSS Day (Rivera-Capella), NMSS Events (email).

UNEXPECTED CONTAMINATION DISCOVERED IN URANIUM AUTOCLAVE

The following information was provided by the licensee via email:

"The plant is in a safe configuration.

"On June 7, 2022, while performing a disconnect on the 3LS1 autoclave, an Operator noticed a white/yellowish film on the hex nut of the manifold and the upper portion of the cylinder valve. The Operator surveyed the film and found 4,000 to 6,000 dpm alpha and beta contamination.

"The 3LS1 autoclave was posted as a Contamination Area at 0152 MDT on June 7th. Surveys of the cylinder and manifold were 1,500 dpm alpha and 3,000 dpm beta/gamma after the disconnect. Decontamination efforts continued throughout the day. The area was still posted as a contamination area on the morning of June 8th. UUSA [Urenco, USA] is reporting this event per 10 CFR 70.50.(b)(1)(i). Decontamination efforts are continuing.

"This issue has been entered in UUSA's corrective action program as EV151830."

The licensee reported leakage inside the autoclave under EN 55930.

EN Revision Imported Date: 6/17/2022

EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO TREATMENT SITE

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

"On 06/08/2022, Inland Northwest (INW) Multicare's radiation safety officer (RSO) reported a medical event had occurred. A Y-90 therasphere procedure was done on the previous day (06/07/2022), the procedure went according to plan, however after the procedure was completed the after injection surveys and quality assurance was done, it revealed that a portion of the microspheres did not come out of the tubing as designed. After calculation it was determined that the patient only received 26 percent of the target dose. The licensee immediately notified the manufacturer to see what happened. The manufacturer told them this is a known issue and has happened before. INW is writing up a full report and will submit it when completed."

WA incident No.: WA-19-004

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 FROM TRISTAN HAY TO DONALD NORWOOD AT 1441 EDT ON 6/16/2022 * * *

The following is a summary of information received via E-mail:

"There has been no indication of non-target embolization delivered to the patient. Crucially, no patient harm has resulted from this medical event. The patient has been contacted and notified by the Authorized User as to the reduced dosage administration during the procedure and is doing well with no indication of post procedure complications.

"The conclusion that was arrived at, after the span of this investigation, is that a definitive root cause cannot be drawn as to why this event occurred. Given all of the information that has been gathered, the source of this medical event can be attributed to microspheres settling out and/or clogging in the delivery system. Whether this can be attributed to the technique used by the performing physician or an equipment failure I cannot definitively say. What is known is over 70 percent of the activity remained in the delivery system and more specifically the tubing. Had the activity that remained in the delivery system been delivered to the patient, there would not have been a medical event occurrence. The known documented and published cases of the microspheres settling out and/or clogging in the delivery system are attributed more commonly to equipment failure as opposed to administration techniques. Given this data it is reasonable to conclude that equipment failure is the most likely cause of this medical event.

"What is also know through the investigation, is that all proper procedures were followed throughout the entire duration of this procedure. Because of that, there are no corrective actions that can be identified to prevent recurrence. This concludes the investigation."

Notified the R4DO (Azua) and the NMSS Events Notification E-mail group.

EN Revision Imported Date: 6/17/2022

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT - DOSE TO SKIN OTHER THAN WRITTEN DIRECTIVE TREATMENT SITE

The following information was received from the Oregon Health Authority via e-mail:

"The following is a report of a medical event corresponding to Subpart M, 35.3045(a)(1)(iii) for a high dose rate afterloader (HDR) dose to the skin other than the treatment site that exceeds 50 rem and 50% of expected dose to the location.

"Description of event: A patient was scheduled for two HDR (Varian GammaMed Plus iX) treatments, one each for two separate lesions located on the patient's lower right leg. The first lesion treatment (5100 cGy total; 17 fractions @ 300 cGy ea) was performed in February without incident. The first fraction of 500 cGy for the second lesion was performed on June 7th. The second treatment was scheduled for June 10th, however, during set-up and after drawing a circle on the patient's leg to help align the second lesion and monitor positioning during treatment, the patient informed the physicist that after the first fraction on June 7th, he noticed the circle had been drawn at that time around the first lesion treated in February. Treatment staff immediately alerted the patient's physician. Images from the patient's treatment on June 7th were compared to the February treatment and found to be the same location as the first lesion. The physician stated there is no adverse effect to the patient since the dose went to the site of the previous February treatment that was 'well tolerated' by the patient and 'the additional one HDR fraction of 500 cGy is likely of benefit to the patient.' The patient's written directive was updated to reflect an additional fraction to be given to the second lesion.

"Cause and corrective actions: The licensee is still gathering information but from the preliminary data received, verification of the treatment site was not performed for the June 7th fraction and former treatment plan location was used. No corrective actions have been submitted at this time.

"Concerns: Verification of treatment site may not be robust enough in separating separate treatment sites that are close together. Only through patient notification was this event identified. Awaiting further information/explanation from licensee."

Oregon Report Identification Number: 22-0028

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 FROM DARYL LEON TO DONALD NORWOOD AT 1544 EDT ON 6/16/2022 * * *

"The following updated / revised information was received via E-mail:

"Description of event: The patient was scheduled for two treatments, one each for two separate lesions located on the patient's lower right leg. The first lesion treatment (5100 cGy total dose; 17 fractions @ 300 cGy ea) using beam therapy (SBRT) was performed in February without incident. The second lesion was not present during this treatment but appeared shortly after. On June 7th, the first fraction of 500 cGy (4000 cGy total dose; 8 fractions at 500 cGy ea) was performed. The second treatment was scheduled for June 10th, however, during set-up and after drawing a circle on the patient's leg to help align the second lesion and monitor positioning during treatment, the patient informed the physicist that after the first fraction on June 7th, he noticed the circle had been drawn at that time around the first lesion treated in February. Treatment staff immediately alerted the patient's physician. Images from the patient's HDR fractionated dose on June 7th were compared to the February external beam treatment and found to be the same location. The physician stated there is no adverse effect to the patient since the dose went to the site of the previous February treatment that was "well tolerated" by the patient and "the additional one HDR fraction of 500 cGy is likely of benefit to the patient". The patient's written directive was updated to reflect an additional fraction to be given to the second lesion.

"Cause and corrective actions:

"Facts to note:
- The second lesion was not present during the February external beam treatment.
- The written directive for the HDR treatment plan for the second lesion stated it was "lateral" than the "more medial" first lesion. Both were within approximately 1.5 inches of each other.
- The patient positioning for external beam was supine and for the HDR, prone.

"This event occurred due to human error. The licensee failed to note the change in patient positioning from supine to prone while using photos of the treatment area resulting in `visual flip' of image nor confirm treatment site from the written directive. A contributing factor is the proximity of the two lesions and another is that the second lesion was not present during the February external beam treatment.

"Stated corrections are to add a pretreatment step for multiple lesions close to each other that include:
- Asking the patient to point to the site to be treated.
- Verification by including more images of the body (hand or foot) along with the lesions to better identify the site and orient treatment personnel.

"Source: Irridium-192
Activity: Approximately 4.8 Ci
Model: Gammamed 232
Serial number: 24-01-0285-001-020422-15242-99
Leak test date: March 17, 2022."

Notified R4DO (Azua) and the NMSS Events Notification E-mail group.