Event Notification Report for December 14, 2022

AGREEMENT STATE REPORT - LEAKING SOURCE

The following information was provided by the the Arizona Department of Health Services (the Department) via email:

"The Department received notification from the licensee of a leak test that exceeded the regulatory limit of 0.005 microcuries. The licensee is going to return the vial to the manufacturer and exchange it for a new vial source. The Department has requested additional information and continues to investigate the event."

[Source information:]
"Cs-137 Vial
"Serial number: 788-3-11
"Assay date: 11/1/2001

"Additional information will be provided as it is received in accordance with SA-300."

Arizona Incident Number: 22-015

AGREEMENT STATE REPORT - OVEREXPOSURE EVENT
The following information was provided by the Texas Department of Health Services (the Agency) via email:
"On December 14, 2022, the Agency was notified by the licensee's radiation safety officer (RSO) of a potential overexposure event. The RSO reported three of their radiographers were working at a remote site using a 30.4 curie cobalt 60 source. The exposure time for each exposure was two minutes. The distance from the source to the pipe was two feet. During the first exposure, one of the radiographers was between the source and the pipe being tested. The RSO stated the individual stayed in the area for about one minute. The radiographer operating the source was standing behind a brick wall and was unaware of the individual being in the area. The operator thought the others had cleared the area, and it was safe to perform the exposure. The individual who received the exposures stated the noise in the area was too loud to hear their alarming rate meter. The exposed individual's self-reading dosimeter was off scale. All radiographers' dosimeters have been sent to the licensee's dosimetry processor for reading. The RSO stated their calculations indicated the individual could have received 7 rem from this event. The RSO stated the individual exposed had received 12 millirem prior to this event. All three individuals have been removed from any duties that would require any additional exposure. Additional information will be provided as it is received in accordance with SA-300."

Texas Incident no.: 9973
Texas NMED no.: TX220041

* * * UPDATE ON 12/16/22 AT 1522 CST FROM ARTHUR L TUCKER TO LAUREN BRYSON * * *
"On December 16, 2022, the licensee reported they had received the badge reading for the individual involved in this event. The Deep Dose Equivalent (DDE) on the badge was 5,450 millirem bringing the individuals DDE total for the year to 5,662 millirem. The Agency has requested the licensee determine if the badge was worn in the highest dose field during the event. Additional information will be provided as it is received in accordance with SA-300."

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

EN Revision Imported Date: 1/11/2023

EN Revision Text: AGREEMENT STATE REPORT - PATIENT UNDERDOSE

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

"The Agency was contacted on 12/14/22 by the medical physicist for Alexian Brothers Medical Center to advise that a Y-90 microsphere administration conducted that morning resulted in a reportable under dose. The administered amount was 20.4 percent lower than that specified in the written directive. This was not a stasis case. The licensee has tried multiple times, but has so far been unable to reach the patient for notification. The referring physician has been notified. Agency inspectors have gathered preliminary information but will conduct a reactionary site visit on Tuesday, 12/20/2022. More information will be provided once it becomes available."

Illinois Event Number: IL220043

* * * UPDATE ON 01/10/2023 AT 1535 EST FROM GARY FORSEE TO ERNEST WEST * * *

"When initially reported, this was not identified as a stasis case. Both the patient and the referring physician were notified within 24 hours. Agency inspectors conducted a reactionary site visit on 12/20/2022. Upon further discussion and investigation, the authorized user (AU) and authorized medical physicist (AMP) believe the procedure may have reached stasis. The AMP acknowledged that additional training needed to be provided to the treatment team regarding procedures reaching stasis. The licensee determined the root cause to be failure to identify stasis. Agency inspectors determined the potential root cause as a failure to follow procedures and lack of sufficient training to the newly hired AU regarding stasis. This incident and the licensee's procedures will be reviewed during the next routine inspection. This matter may be considered closed."

Notified R3DO (Edwards) and NMSS Event Notifications 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 - TWO UNDER DOSES AND CONTAMINATED INDIVIDUAL

The following information was provided by the Washington Office of Radiation Protection via email:

"This is an event report involving two patients and a technologist [which occurred on 12/14/2022].

"The first patient was being treated for prostate cancer with the radiopharmaceutical PLUVICTO (lutetium-177 vipivotide tetraxetan). The apparatus that is normally used for administering the radiopharmaceutical was not available due to supply chain issues, so a similar apparatus where the infusion vial would be pressurized was used instead. Unfortunately, the radiopharmaceutical began to leak out of the rubber septum of the vial and into the shielded storage container. As soon as the leak was identified, the pump was stopped and the case was aborted, resulting in the dosage delivered being less than the prescribed dose by more than twenty percent. 200 millicuries had been prescribed, but only 129 millicuries was administered to the patient. There may have been too much pressure in the vial, which forced the liquid out of the pierced septum near the needles.

"The patient will continue receiving the remainder of their planned treatments. The effects and appropriate response to missing a partial dose will be discussed with the care team and the drug manufacturer. (The typical recommended treatment is 200 millicuries every six weeks for up to six doses.) The licensee will use a different administration method and apparatus that uses a syringe pump instead of a pressurized vial.

"The second patient was being treated for prostate cancer with the radiopharmaceutical PLUVICTO (lutetium-177 vipivotide tetraxetan). The apparatus that is normally used for administering the radiopharmaceutical was not available due to supply chain issues, so a similar apparatus where the infusion vial would be pressurized was used instead. Unfortunately, radiopharmaceutical began to leak out of the rubber septum of the vial and into the shielded storage container. As soon as the leak was identified, the pump was stopped and the case was aborted, resulting in the dosage delivered being less than the prescribed dose by more than twenty percent. 200 millicuries had been prescribed, but only 121 millicuries was administered to the patient. There may have been too much pressure in the vial, which forced the liquid out of the pierced septum near the needles.

"Due to a cancellation, on the next day (12/15/2022) a dose of PLUVICTO was available and after consultation with the patient, the nuclear medicine team including other authorized users, and the referring physician, it was agreed to inject a partial dose so that the full 200 millicuries originally prescribed would be delivered. The clinical team agreed on the medical necessity and safety of this fractionated administration. The second infusion was completed without incident and was well tolerated by the patient.

"At the manufacturer's web site in the prescribing information for PLUVICTO, a few options are given for administering PLUVICTO. None of those options involve pressurizing the vial of PLUVICTO. This does not appear to be a good practice, and appears to have resulted in the leak.

"Unfortunately, one of the technologists involved in the cleanup of the radiopharmaceutical spills [from the leaking vials] had contamination on his hand that he and radiation safety staff were unable to remove. The Washington State Department of Health has asked for additional details on how the contamination occurred, the radiation readings, and dose estimates, and suggested contacting the U.S. Department of Energy's Radiation Emergency Assistance Center / Training Site for help with dose calculations, decontamination advice, and advice on any additional medical care that the technologist may need in the future because of his radiation dose."

Washington Report Number: WA-23-002

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 CARBON-14 RADIOACTIVE MATERIAL

The following information was provided by the Arizona Department of Health Services (the Department) via email:

"On January 12, 2024, the Department received notification from the licensee that 568 millicuries of C-14 was found to be missing on December 14, 2023. The licensee stated that the radioactive material was last seen sometime in July of 2023 during their last manufacturing run. The Department has requested additional information and continues to investigate the event."

Arizona Incident: 24-001

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