Event Notification Report for August 27, 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

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.