Event Notification Report for August 28, 2024

AGREEMENT STATE REPORT - MEDICAL UNDERDOSE

The following information was provided by the Kentucky Department for Public Health & Safety, Radiation Health Branch (KY RHB) via email:

"KY RHB was notified on August 20, 2024, by a representative from Leonard Lawson Cancer Center [of the following:]
"The date of discovery is August 20, 2024 at 13:30 EDT. There were two medical events for the same patient receiving Ra-223 dichloride. In each of the two cases, the patient was under dosed.
"The authorized user physician and the patient have been notified of the medical events.
"The first dose was administered on July 9, 2024, with a prescribed dose of 91.2 micro Ci and an administered dose of 72.46 micro Ci with a difference of 20.5 percent.
[The second dose is being tracked under a different NRC Event number. See EN 57276]
"The written directive procedure is to measure the dose in the dose calibrator and then administer the dose. The medical physicians deviated from the written directive procedure and adjusted the dose based of the following calculation:
"Volume to administered equals (Body weight in kg x 1.35 micro Ci/kg)/(decay factor x 27 micro Ci/ml).
"The concentration provided in the formula is different than the concentration for each dose. The concentration for the first dose was 19.17 micro Ci/ml. Also, this formula was taken from an old Bayer document from 2013. The current Bayer document provides the following formula.
"Volume to administered equals (Body weight in kg x 1.49 micro Ci/kg)/(decay factor x 30 micro Ci/ml).
"The problem is the document does not instruct one to use an actual concentration for the patient specific dose.
"The two reasons for the medical events are:
"1) The medical physicist did not follow the written directive procedure. He added the volume calculation step.
"2) The Bayer documentation does not instruct you to use the actual concentration for the patient specific dose.
"The incident remains under evaluation and investigation for corrective actions."


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 - MEDICAL UNDERDOSE

The following information was provided by the Kentucky Department for Public Health & Safety, Radiation Health Branch (KY RHB) via email:

"KY RHB was notified on August 20, 2024, by a representative from Leonard Lawson Cancer Center [of the following:]
"The date of discovery is August 20, 2024 at 13:30 EDT.
"There were two medical events for the same patient receiving Ra-223 dichloride. In each of the two cases, the patient was under dosed.
"The authorized user physician and the patient have been notified of the medical events.
[The first dose is being tracked under a different NRC Event number. See EN 57275]
"The second dose was administered on August 7, 2024, with a prescribed dose of 89.2 micro Ci and an administered dose of 45.53 micro Ci with a difference of 53.9 percent.
"The written directive procedure is to measure the dose in the dose calibrator and then administer the dose. The medical physicians deviated from the written directive procedure and adjusted the dose based of the following calculation:
"Volume to administered equals (Body weight in kg x 1.35 micro Ci/kg)/(decay factor x 27 micro Ci/ml).
"The concentration provided in the formula is different than the concentration for each dose. The concentration for the second dose was 18.12 micro Ci/ml. Also, this formula was taken from an old Bayer document from 2013. The current Bayer document provides the following formula.
"Volume to administered equals (Body weight in kg x 1.49 micro Ci/kg)/(decay factor x 30 micro Ci/ml).
"The problem is the document does not instruct one to use an actual concentration for the patient specific dose.
"The two reasons for the medical events are:
"1) The medical physicist did not follow the written directive procedure. He added the volume calculation step.
"2) The Bayer documentation does not instruct you to use the actual concentration for the patient specific dose.
"The incident remains under evaluation and investigation for corrective actions."

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 - GAUGE SHUTTERS FOUND OPEN WITHOUT COMMAND

The following information was provided by the Tennessee Division of Radiological Health via email:

"It was discovered on August 19, 2024, that three (3) fixed gauges had shutters that were open without commands to open from the PLC terminal. The area was unoccupied at the time. The facility radiation safety officer (RSO) did not indicate any physical damage to the devices. The event occurred again on the morning of August 20, 2024. No exposure was noted since the gauges were operating in a normal capacity. The RSO had the shutters closed and took the gauges out of service. The gauges were also locked out to prevent reoccurrence. The gauge manufacturer has been contacted for troubleshooting the occurrence. The available device information is as follows:
"Manufacturer: Mahlo America, Inc.
"Model: 11-200933 (source holder)
"Isotope: Kr-85, 260 mCi (as of March 28, 2019)
"Source SN#: AN-3035, AN-3036, AN-3037
"Corrective actions will be updated with a report within 30 days."


Tennessee Event Report Number: TN-24-060

MEDICAL UNDERDOSE

The following information was provided by the Department of Veterans Affairs (VA) via email:

"VA Boston Healthcare System, Boston, Massachusetts, which holds Veterans Health Administration (VHA) Permit Number 20-00671-02 under the VA Master Materials License, reported discovery of a medical event to the National Health Physics Program (NHPP) at approximately 1410 CDT, August 20, 2024. A therapeutic administration of Y-90 microspheres (TheraSphere) to the right lobe of a patient's liver was conducted at approximately 1300 EDT on August 20, 2024. Measurements and calculations indicated the patient received about 63 percent of the prescribed activity. The prescribed activity was 42.9 mCi; the administered activity was estimated at 27 mCi. A causal analysis of the medical event is being performed by the medical center.

"The patient and the referring physician have been notified. Short term harm to the patient is not expected. NHPP plans to perform a reactive inspection to assess causes and regulatory compliance. NHPP will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045. NHPP has notified the NRC Region III Project Manager, Bryan Parker."

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 - DAMAGED GAUGE

The following summary was provided by the Utah Department of Environmental Quality, Division of Waste Management and Radiation Control (DWMRC) via phone and email:

The licensee (IGES INGENIEROS, L.L.C. DBA GEOSTRATA) contacted the DWMRC to report that a portable gauge, Troxler 3430 model, with a 8 mCi Cs-137 and a 40 mCi Am-241/Be source, fall off the back of a truck. Once the licensee noticed the gauge was missing, they returned to the scene and found the damaged gauge. Although the gauge was in pieces, the sources were intact and there was no apparent leakage identified. Swipe tests were taken and the results are pending.

Utah event report ID number: UT 240006

EN Revision Imported Date: 8/27/2024

EN Revision Text: FALSE NEGATIVE INDICATED ON A FITNESS FOR DUTY BLIND QUALITY ASSURANCE TEST

The following information was provided by the licensee via email:

"On 8/26/2024 at 1200 CDT, Farley Nuclear Plant Medical Services identified a false negative quality assurance test. [The contracted laboratory] was provided an adulterated sample of hydrocodone and hydromorphone that was part of a blind performance test. The results from the [contracted laboratory] returned a false negative. This false negative test result will be investigated, and the results reported as required.

"This event is being reported in accordance with 10 CFR 26.719(c)(3).

"The NRC resident inspector has been notified."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officer Report Guidance:

The contracted laboratory was a U.S. Department of Health and Human Service (HHS) certified laboratory.