Event Notification Report for July 30, 2021

EN Revision Imported Date: 7/30/2021

EN Revision Text: AGREEMENT STATE REPORT - Y-90 MICROSPHERE UNDERDOSE

The following was received from the Colorado Department of Public Health and Environment via email:

"Y-90 TheraSphere procedure misadministration: 60.8 mCi was the prescribed dose and 0 mCi was the administered dose."

Colorado Event Report ID No.: CO 210017

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: 7/30/2021

EN Revision Text: AGREEMENT STATE REPORT - RADIOGRAPHY SOURCE FAILED TO RETRACT

The following was received via an email from the Pennsylvania Bureau of Radiation:

"The licensee reported that on July 21, 2021, while using a QSA Global Model 880 containing a 135.5 curie source of iridium-192, the source failed to fully retract and lock. The source serial number is 32578M and the camera serial number is D9477. The technicians secured the area by adjusting their 2 mR/hr boundaries to an unshielded source distance and immediately contacted their company [Radiation Safety Officer] (RSO). The licensee then contacted QSA Global who will be onsite on July 22, 2021, to retrieve the source and take the camera and entire crank and assembly mechanism with them for evaluation. The licensee will remain onsite to secure the boundary until QSA arrives. No overexposures have occurred and all proper procedures were followed. The cause of the malfunction remains unknown. More information will be provided when received."

Pennsylvania Event Report ID No.: PA210007

* * * UPDATE ON 7/23/2021 AT 0738 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *

The following update was received via an email from the Pennsylvania Bureau of Radiation:

"QSA arrived on site at approximately 2000 EDT on July 22, 2021, and the source was moved to a locked position in the camera at 2155 EDT. At this time the drive cable is suspected to be the problem. The camera and drive system will be evaluated."

Notified R1DO (Gray) and NMSS Events Notification via email.

EN Revision Imported Date: 7/30/2021

EN Revision Text: AGREEMENT STATE REPORT - DAMAGE TO PORTABLE MOISTURE DENSITY GAUGE

The following was received from the Virginia Radioactive Materials Program (VRMP) via email:

"On July 22, 2021, at 0950 EDT, VRMP received a report via telephone from the Radiological Duty Officer of the Virginia Office of Radiological Health that a portable nuclear moisture/density gauge was damaged when hit by a car at a temporary jobsite. At 1000 EDT, the VRMP contacted the Radiation Safety Officer (RSO) of the licensee. The RSO stated that a Troxler density gauge (Model 4640-B, serial number 2266, containing 8 milliCuries of cesium-137) was hit by a car at a temporary jobsite. The gauge housing was damaged, but the source appeared to remain intact within the safe position. The licensee's survey of the gauge yielded readings of 0.02 mR/hr at about a foot distance from the gauge. The gauge was taken to the licensee's office in its transport container. A survey was also performed on the ground and the reading was reported as background. The gauge will be tested for leakage and after testing, it will be sent to the Troxler Electronics Laboratories for evaluation. The VRMP is working with the licensee to obtain additional information. This report will be updated once the licensee's investigation is complete and the information is received by the VRMP. According to the RSO, no public or personnel exposure occurred."

Event Report ID No.: VA210004

EN Revision Imported Date: 7/30/2021

EN Revision Text: AGREEMENT STATE REPORT - CONTAMINATED PACKAGE

The following was received from the California Radiologic Health Branch (RHB) via email:

"The licensee reported that on 7/13/2021, they received an externally contaminated package containing two unit doses of F-18 (110 minute T1/2 [half life]). The licensee's receipt survey found the outer surface removable contamination level to be 5,417,497 dpm per 100 sq cm. The inside of the package, including the F-18 vials, were not contaminated. The radiopharmacy courier was informed of the excessive contamination, and the radiopharmacy was contacted. The package radiation levels were acceptable. The package was received from Optimal Tracers (CA-RML 7975). RHB will investigate this matter further, including onsite at Optimal Tracers' facility."

5010 Number: 071921

EN Revision Imported Date: 7/30/2021

EN Revision Text:
AGREEMENT STATE REPORT - PATIENT UNDER DOSE

The following was received via an email from the Pennsylvania Department of Environmental Protection (DEP) via email:

"On July 22, 2021 a patient was receiving a Lutetium-177 (Lutathera) treatment when technicians had difficulty establishing an IV injection site and flow. Several attempts were made, but ultimately they all failed. The prescribed dose was 200 milliCuries, but it is estimated that the patient received only 18 millicuries. No adverse effects to the patient are noted at this time and none are expected. The patient and prescribing physician have been informed. Preliminary cause is suspected to be poor venous access for patient as well as incorrect gauge needle used for patient access. The DEP will update this event as soon as more information is provided.

"The Department will perform a reactive inspection."

Pennsylvania Event Report ID No: PA210008

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: 7/30/2021

EN Revision Text: AGREEMENT STATE REPORT - LOST I-125 BRACHYTHERAPY SEED

The following was received via email from the North Carolina Radiation Protection Section (NC RPS) via email:

"On 07/06/2021 at 1554 EDT [the licensee] Chief Diagnostic Medical Physicist emailed NC RPS about a lost Iodine-125 seed. Seeds are used for localization of non-palpable breast nodules. The event occurred on 06/30/2021 but was not reported to [the Chief Diagnostic Medical Physicist] until 07/06/2021. On 07/07/2021 North Carolina Inspections Supervisor forwarded the email to an Inspector for review.

"The seed was assayed on 06/09/2021 with an activity of 0.15 mCi. The event originated at Atrium Health Union, 600 Hospital Drive, Monroe, NC 28112 under license number 090-0739-1. The seed was identified by imaging at the Monroe Breast Center prior to shipment. Surveys of the transport container were also performed before it left the facility confirming the seed was present. Image was included with follow up email. Atrium Health Union nuclear medical staff used a Ludlum Mo. 14-C with GM pancake probe, serial number 73404, calibration due 07/28/2021. Survey of package exterior showed a reading of 0.05 mR/hr and less than 0.02 mR/hr at one meter. The package left the facility at 1347 EDT on 06/30/2021. A courier service is used to transport specimens.

"Charlotte-Mecklenburg Hospital Authority's Carolinas Medical Center (CMC) pathology lab received the package at 1525 EDT on 06/30/2021. CMC pathology lab staff failed to perform package survey at time of receipt. The specimen was removed from the transport case and radiographed using a Faxitron cabinet x-ray unit on 06/30/2021. At this point, pathology staff found that the seed was not present in the specimen tissue. Image was included with initial notification email. At this point, pathology staff did not follow established procedures to notify CMC Radiation Safety staff.

"On 07/06/2021 [the CMC] Radiation Safety Officer (RSO) was notified of the incident. Radiation Safety staff immediately went to the CMC pathology lab and surveyed the lab using a Ludlum Mo. 2241 with a NaI probe, serial number 217339. Surveying began at 0830 EDT on 07/06/2021. The transport container, all work areas, all biological waste containers, floor areas, counters, and all areas where the seed could be located were surveyed. All readings were at background radiation levels (<0.02 mR/hr) and seed was not located.

"Seed Information:
Manufacturer: Best Medical
Lot#: 52188A-6
Radiation Type: low E gamma emitter
Activity: 0.15 mCi, assayed on 06/09/2021

"Licensee identified multiple failures which lead to the incident, including:
1. Failure of pathology lab staff to carefully handle specimen.
2. Failure to notify RSO at initial finding of incident.
3. Failure of pathology lab to follow established procedures.
4. Receiving notification at such a later date greatly diminishes likelihood of finding lost seed.

"Licensee proposed several corrective actions to prevent reoccurrence, including:
1. All pathology staff on radiation program will receive refresher training.
2. CMC pathology will have more accountability regarding the handling of radioactive material.
3. All specimens containing radioactive material received from outside facilities must be received at CMC pathology lab prior to 1600 EDT.
4. Extra stickers and labels will be utilized to clearly identify specimens containing radioactive material.
5. CMC pathology lab will handle specimens with extreme caution due to small size of seeds."

North Carolina Incident Number: NC210012

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

EN Revision Imported Date: 7/30/2021

EN Revision Text: FITNESS FOR DUTY REPORT

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

The NRC Resident Inspector has been notified.