Event Notification Report for August 06, 2021

EN Revision Imported Date: 8/6/2021

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL MISADMINISTRATION

The following information was received from NMED for the Georgia Radioactive Materials Program:

"This incident occurred on July 14 at Piedmont Fayette Hospital (GA 1340-1). The unnecessary study was an administration of 25.6 mCi of Tc-99m exametazime-labeled white blood cells (Ceretec WBC), for which the TEDE was about 9 mSv. The individual who received the unnecessary study only came to the hospital for the study and was not an inpatient or there for any other reason."

Georgia Incident Number: 45

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: 8/6/2021

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT

The following was received from the Kentucky Department of Radiation Control, Radiation Health Branch (RHB) via email:

"At approximately 1230 CDT on 7/29/21 the Hospital [Radiation Safety Officer] RSO called RHB to report a failure of a Therasphere Y-90 administration kit. Authorized User (AU) indicated an almost immediate failure to administer the dose. There was no flow into the administration catheter. Saline observed exiting the administration set up into an overflow vial. After adjusting the pressure and a second attempt failed, a call was placed to the administration kit representative. Three more attempts failed. The AU decided to stop the process and remove the administration catheter. Patient procedure was stopped. Not rescheduled at this time. A survey of the vial and administration set up, and multiple patient surveys seem to indicate that no dose was administered to the patient.

"Y-90 set up and vials were packaged and stored into appropriate waste. No contamination, no release of material. No patient administration. Expected 4.15 GBq and received none. Licensee suspects an administration set up kit failure. Licensee will provide full reports to the RHB staff within 15 days."

KY Event Report ID: 210002

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: 8/6/2021

EN Revision Text: DAMAGED INSTROTEK MOISTURE DENSITY GAUGE

The following is a summary of a phone call with the licensee:

On 7/30/2021 while at the jobsite in Moca, Puerto Rico, the licensee's InstroTek MC-3 Elite gauge was run over by a paving roller while in the safety drum. The gauge plastic casing was damaged and the source rod was broken. The sources were in the shielded position at the time of the incident. The InstroTek gauge serial number is 31331 and contains nominally 10 mCi of Cs-137 and 50 mCi of AmBe.

The damaged gauge was placed in its storage container and returned to the licensee's Cabo Rojo facility for a swipe test. After the incident, the gauge read 0.2 to 0.3 mR/hr at 1 meter with a survey meter.

No overexposures were reported.


* * * RETRACTION ON 8/3/21 AT 1320 EDT FROM ALFONSO BOSQUE TO KERBY SCALES * * *

The following retraction is a summary of a phone call with the licensee:

The Radiation Safety Officer inspected the gauge and verified that the gauge maintained its safety function. The source was secured and a leak test verified no leakage.

Notified R1DO (Eve) and NMSS Event Notification via email.

EN Revision Imported Date: 8/6/2021

EN Revision Text: AGEEMENT STATE REPORT - MEDICAL EVENT

The following was received from the Minnesota Department of Health via email:

"The Mayo Clinic Rochester, MN had a medical event in which the total dose differs from the prescribed dose by greater than 20 percent and the dose difference to the whole body exceeds 5 rem. Under clinical trials on 7/29/2021, a patient who was prescribed 11.2 mCi of I-131 as an infusion of IOMAB-B Therapy, only received 5.74 mCi. The licensee reports an issue with air in the tubing that prevented the entire administration of the treatment. They are continuing to investigate and will submit a final report within 15 days."

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: 8/6/2021

EN Revision Text: NON-LICENSED SUPERVISORY PERSONNEL VIOLATED FFD POLICY

A non-licensed supervisor had a confirmed positive for alcohol during a random fitness-for-duty test. The employee's access to the plant has been terminated.

The NRC Resident Inspector has been notified.