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ENS 5669122 August 2023 16:53:00The following information was received via email from the North Carolina Radioactive Material Branch: The Licensee Authorized User was on a construction site in Dunn performing compaction testing with the referenced nuclear gauge. The area was an open fill section with dump trucks back dumping upon arrival. The contractor requested a test for the current fill layer and the field technician randomly picked a location. There were no dump trucks onsite at the time of the testing. After taking the density test with Gauge 1029, the field technician properly placed the source rod back in the safe position prior to the incident. The technician turned to tell the contractor the test results, then took a few steps (about 12 feet) away from the gauge due to the equipment noise. When he turned around to get the gauge, a dump truck was about twenty feet away heading towards the gauge. The technician immediately started flagging and yelling for the truck to stop due to the proximity of the work area. The driver's attention was in another direction, so he didn't hear or see the field technician's efforts to prevent the accident. The driver ran over the gauge and stopped to see what happened. After a brief conversation, the truck driver left the site. The field technician notified the local Radiation Safety Officer (RSO) and Office Manager of the incident. The RSO instructed the employee to secure the area and to prevent access until he could get there. The local RSO, Office Manager, and Director of Subsidiary Safety responded and arrived at the incident location within 1 hour of the notification. ECS called the North Carolina Emergency Management telephone number and informed them that a nuclear moisture - density gauge had been run over by construction equipment, that the source rod had come out of the gauge but had been placed back into the shielded position. Upon arrival, the field technician and grading contractor employees were interviewed by the RSO. The gauge and test location were surveyed using a calibrated survey meter (Model Radalert, Serial No.: 7326, last calibrated March 26, 2023) by the RSO while approaching the gauge to ensure that the source was in the shielded position and that the transport index was within the acceptable range. The source rod was bent about 6 inches up and the guide rod was broken. The source was confirmed to be in the secured safe position and after the survey was placed in the transport case. Due to the bend handle, the case lid would not close fully on the gauge transport case, so it was pulled tightly to within 2 inches of closing and secured with a python cable and locked. A nuclear safety stand down occurred with all parties involved in the incident upon securing the gauge. The field technician was immediately reinstructed in proper gauge handling requirements. The licensee also scheduled a formal retraining session for the field technician for the following day. All ECS Authorized Users at the licensee's other North Carolina location will receive retraining in gauge security and situational awareness within the next 2 weeks. A leak test was performed on gauge 1029 and the test specimen was transported to Instrotek. No leakage was detected. Gauge Manufacturer: Instrotek Model Number: 3500 Serial Number: 1029 Cs-137 Source Manufacturer: Eckert and Ziegler Model Number: Cs-137 Serial Number: cz-2185 Activity: 10 mCi Am-241 Source Manufacturer: Eckert and Ziegler Model Number: AmBe-241 Serial Number: 127/09 Activity: 40 mCi
ENS 5627919 December 2022 08:59:00The following is a summary information was provided by the North Carolina Division of Radiation Protection via email: On 12/13/2022, the licensee discovered that a source from a shipment of sources received on 9/1/2022, was missing from their inventory. The licensee conducted surveys of the area and did not detect the source. None of the shipping containers or bags were damaged, indicating that the source was not lost during shipping and was either not included in the original shipment from the shipper or was lost after the licensee received the shipment. The original shipper of the source was contacted and informed of the missing source; they are performing checks to verify if the source was indeed shipped to the licensee. Source: Am-241/Be Activity: 40 mCi Manufacturer: Eckert & Ziegler Model: K Model, Batch S/N: K364-22 NC Event Number: NC220016 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
ENS 562114 November 2022 17:09:00

The following information was provided by North Carolina Department of Health and Human Services via email: Licensee reported a portable nuclear gauge (Troxler model 3400 containing Cs-137 and Am-241 sources) was damaged by a work truck at a construction site on 11/4/22. Inspector was dispatched to investigate immediately. The technician utilizing the gauge was able to cordon off the area to secure the gauge. Licensee was able to retrieve the gauge and verify the source rod was intact and retracted back into the gauge. Surveys confirmed the sources were intact and in the shielded position. The gauge sustained damage to its outer housing and is being transported to the manufacturer for repair. More information will be provided to close and complete this report. NC Event No: TBD

  • * * UPDATE ON 11/16/2022 AT 1505 EST FROM TRAVIS CARTOSKI TO KAREN COTTON * * *

The following information is a summary of information received via email: After investigation, the North Carolina Department of Health and Human Services updated this report to state that the cause of the damaged gauge was due to a vehicular accident and the corrective actions are to provide gauge user retraining. The North Carolina Department of Health and Human Services considers this event be closed and complete. Notified R1DO (Dimitriadis) and NMSS Events Notification email group.

ENS 5583311 April 2022 11:20:00The following was received via an email from the state of North Carolina: A portable nuclear density gauge was reported stolen from a job site located at a large construction site in Kernersville, NC. The gauge was secured in a large Conex box (large cargo container) at the site. Inside the Conex box there is a rigid box secured to the inside of the Conex box. The gauge was secured and locked inside of this rigid box and the Conex box itself was locked as well. On 4/11, licensee personnel discovered that the rigid box containing the gauge was missing from inside the Conex box. An inspector has been assigned this incident for investigation and details will follow to update, close, and complete this report. North Carolina Tracking Number: 220003. 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
ENS 5541920 August 2021 10:05:00The following information was received from the state of North Carolina via email: A licensee reported a medical event involving a patient treated for prostate cancer. The treatment included implanting 54 iodine-125 brachytherapy seeds, containing a total activity of 1.012986 GBq (27.378 mCi), in the patient's prostate for a prescribed therapeutic radiation dose of 14500 cGy (rad). The seeds were implanted on 7/26/21. On 8/17/21, the patient's follow up implant CT scan revealed that all 54 seeds were implanted in the penile bulb, outside of the intended target. An inspector was dispatched on 8/18/21. The patient and physician were notified. Through subsequent interviews with the Medical Physicist involved, the Radiation Safety Officer, and the Chief Physicist, malfunction of the ultrasound unit was ruled out. A discussion evolved during review of the ultrasound images from the procedure where a foley catheter inserted in the patient appeared partially visible marking the location of the bladder. The physicist's retrospective review indicates that if the foley catheter is not clearly visible then it could result in seed implantation in a patient's anatomy other than the prostate. An unintended dose to the penile bulb of approximately 14500 cGy (rad) was received, where no dose was anticipated. Currently, the cause appears to be human error and our investigation is ongoing. Pending corrective actions include changes to the prostate brachytherapy protocol to incorporate an additional step to ensure personnel clearly identify the prostate gland and the surrounding anatomy. Previous cases involving this type of procedure do not indicate that this error has been occurring, unaccounted for, prior to this event, due to the follow-up CT scans performed post-op per the licensee's internal procedures. NMED Report No.: NC210014 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.
ENS 5537823 July 2021 15:52:00The 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
ENS 5532323 June 2021 11:28:00The following report was received from the North Carolina (NC) Division of Health Service Regulation via email: A NC General Licensee reports the loss of 8 NRD Advanced Static Control devices. Each device contained Po-210 with an activity of 10 mCi, each. General License: TBD as at the time of this report our General License Coordinator is currently unavailable. The licensee reports that the devices may have been inadvertently disposed of and their search continues at this time. This report remains incomplete but shall be updated to complete and close the record. Advanced Static Control Device: Manufacturer: NRD Inc.; Model: P-2021-Z705; S/N's: A2MB768, A2MB770, A2MB771, A2MB775, A2MB777, A2MB731, A2MB736, A2MB738 Sources Information: Po-210 Activity .01 Ci each NC Item Number: NC210010 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
ENS 5527927 May 2021 14:31:00

The following report was received from the North Carolina Division of Health Service Regulation via email: The facility had two I-125 prostate implant procedures scheduled for 5/26/2021, one from approximately 0800-1030 EDT and another one following that. During the preparation of the second patient, the (authorized medical physicist/ radiation safety officer) (AMP/RSO) realized he may have made a mistake inputting the source strength into the treatment planning computer. The treatment planning computer has two options for source strength (millicuries and air-kerma). He went back to verify and realized he had input the millicurie source strength (0.357 mCi) into the air-kerma strength (0.453 U) spot and not air-kerma. This resulted in the treatment planning computer to believe the activity of the sources were lower than they actually were and generated a plan off of this strength. This caused the delivered dosage to be 27 percent greater than the prescribed dosage (~1400 Gy not 1100 Gy). The referring physician was present for the procedure and was notified upon the realization of the error. The patient was still in recovery from the procedure and was informed by the authorized user as soon as he was recovered and able to receive the news, before leaving the facility. The AMP/RSO stated that no negative outcome was expected for the patient, as this was the first part of a two part treatment plan, with the second part being linear accelerator treatment on the prostate. The second part of the treatment can be adjusted to accommodate for the increased dose given during the permanent implant, with no expected harm to the patient. NC Tracking Number: NC210008 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.

  • * * UPDATE FROM TRAVIS CARTOSKI TO DONALD NORWOOD AT 1512 EDT ON 6/9/2021 * * *

The following information was received via E-mail from the North Carolina Division of Health Service Regulation: Corrective Actions: Procedure Revision. The North Carolina Division of Health Service Regulation has completed their investigation and considers the event closed. Notified R1DO (Ferdas) and the NMSS Events Notification E-mail group.

ENS 552376 May 2021 13:01:00The following notice was received from the State of North Carolina Radioactive Materials Branch (RMB), via email: A portable nuclear density gauge was reported stolen out of a licensee's flatbed truck, sometime during the evening of May 5th. The gauge was reported as secured from unauthorized removal by two independent means and padlocked in its transportation case. The truck was parked in front of the personal residence of one of the licensee's authorized users overnight. The morning of May 6th, the authorized user noticed the gauge case missing with locks and chains broken. The authorized user immediately called 911 and notified the licensee's Radiation Safety Officer immediately, who in turn, notified the RMB who responded to the scene of the theft the morning of (May) 6th. RMB is preparing a press release in an effort to recover the gauge and its investigation is ongoing. Durham Police Department was notified. Gauge Information: Manufacturer: Troxler; Model: 3430P; S/N: 71890 Sources Information: CS-137 0.300 GBq, 8.0 mCi; Am-241 BE, 40.0 mCi North Carolina Tracking Number: 210006 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
ENS 5499916 November 2020 11:08:00The following was received from the state of North Carolina, Radioactive Materials Branch (RMB): Licensee reports that a laminating device containing a Kr-85 source was inadvertently disposed through their recycling service on 10/1 and was discovered missing on 11/4. On 11/5, working with the licensee, RMB was able to trace the disposal of the device to a recycling yard in York, SC. Licensee arranged with an authorized service provider that was able to assess the device for leakage/contamination and arrange for transport to return to vendor. No evidence of leakage or contamination was found, and the device was packaged and removed from the recycling yard on 11/6. South Carolina DHEC (Department of Health and Environmental Control) was made aware of this incident on 11/5. Device Manufacturer: INDEV, Model: 015030-2, Serial: 2289-4 Source Manufacturer: INDEV, Model: 127-2, Isotope: Kr-85, Serial: KV-412, Activity: 500 mCi Cause: The licensee identified the cause as human error/process error. Corrective Action(s): Re-training of personnel, Methods & Procedure reviews and revising existing procedures. NC event number: 200022 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
ENS 5441526 November 2019 16:28:00The following report was received from the North Carolina Department of Health and Human Services via email: RMB (North Carolina Radioactive Materials Branch) received a report of a portable nuclear gauge that was run over at a job site. The gauge was cordoned off and is away from any pedestrian areas. At the time of this report, based on on-site photos provided by the licensee; the source rod is retracted and is undamaged and initial surveys show no leakage. Gauge outer housing appears damaged but intact. Intertek will be arriving to take possession of the gauge to transport for repair. Inspector has been dispatched to conduct an on-site investigation. Additional information will be provided to update, complete & close this report. Our (North Carolina Department of Health and Human Services) investigation is ongoing. The gauge is a Troxler model number 3430. NC Event Report ID. NO.: 190041
ENS 5439216 November 2019 21:06:00The following summary report was received from the North Carolina Radioactive Materials Branch via email: This happened 11/15/19 and (the Nucor Environmental Manager) was made aware of the incident around (1400 EST), yesterday. Nucor Steel has a 2015 fixed nuclear gauge in a c-frame that was due for maintenance. The gauge was deemed offline and they rolled the c-frame to a locked location where they were to perform scheduled maintenance. It was at this time that they discovered the shutter was stuck open. They tried to close the shutter (with air) but it would not close. (The Nucor Environmental Manager) explained that they roll the gauge by motor, and that during this time the shutter was opened. No employee was exposed to radiation. This gauge is exposed to the elements and (the Nucor Environmental Manager) believes there is dirt inhibiting the shutter from closing. Since they could not get it to close, they rolled the gauge back to its normal online position where it can be open and not at risk to employees. (The Nucor Environmental Manager) stated there is no damage to the source and there (are) not any leaks. (The Nucor Environmental Manager) called the manufacturer to come perform maintenance yesterday. They arrived at his facility around (1400) today and are currently working on the gauge.
ENS 5433617 October 2019 16:56:00The following is the summary of an email received from the state of North Carolina: A patient was scheduled for an intravascular brachytherapy treatment on 10/16/2019. The treatment utilized a Novoste transfer device with an Sr-90 source. The prescribed dose for the treatment was 23.0 Gy, which corresponds to a planned treatment time of 5 minutes and 47 seconds. The treatment was delivered and the source return process was initiated. Resistance was encountered returning the source to the transfer device and the team had to commence the emergency bail-out procedure. The catheter was extracted while it was still attached to the device and both were placed in the bail-out box. The patient, room, and box were all surveyed. The survey confirmed that the source was in the bail-out box. The box was then transferred to a designated secure location. Because of the additional time elapsed between the expected return of the source to the transfer device and the securing of the source in the bail-out box it is possible that the patient could have received an additional dose of up to 6.98 Gy. The manufacturer of the transfer device was notified of this event on 10/16/2019. The patient and referring physician were both notified on 10/17/2019. Device Information: Transfer Device Manufacturer: Novoste (Best Medical) Model: Beta Cath System Serial: 91806 Source Information: Sr-90 Manufacturer: Novoste Activity: 2.01 GBq (4/16/03) Serial: ZB607 NC Tracking Number: NC 190036 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.
ENS 543031 October 2019 09:15:00The following information was received via E-mail: A general licensee reports that following a recent inventory audit, they could not account for 17 missing tritium exit signs. The missing signs could not be accounted for physically by the licensee or verified through formal documentation that the signs were sent for disposal. The signs are believed to be Safety Light Corporation model number 2040 signs. The serial numbers were not reported. NC Tracking Number: NC 190033 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
ENS 5428217 September 2019 13:09:00The following information is a summary of an email received from the state of North Carolina: On September 16, 2019, a patient at Duke University Medical Center was prescribed 43.2 mCi of Y-90 Theraspheres to the liver, but received 89.6 mCi. While the cause of the misadministration is not clear at this time, it is known that the dose received was intended for a different patient. Both the patient and the authorized user have been informed of the incident. An inspector has been dispatched to conduct a reactive inspection for this event. North Carolina Tracking Number: 190032 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.
ENS 541539 July 2019 09:06:00The following report was received from the State of North Carolina: On 7/8/19 around 1200 EDT, the North Carolina Radioactive Materials Branch (RMB) received a call from NC Emergency Management and Durham area police that a yellow package was found on the side of the road at a carwash in Durham, NC. Emergency management and police recognized the package as a possible portable gauge contained in a standard transport case. Readings were immediately taken and the package cordoned off to prevent any public exposures. RMB dispatched an inspector and was on-site within an hour of notification. It was found that the licensee who possessed the portable gauge had removed the gauge in its transport box from his vehicle earlier that morning to wash the vehicle. After finishing, the gauge fell off the vehicle when the licensee departed the car wash. Once the licensee noticed the gauge was missing, they retraced their steps back to the car wash to attempt to reclaim the gauge and were met by local police and emergency management. The gauge was left unattended for approximately 4-5 hours. The licensee is now in possession of the gauge. The RMB inspector discovered multiple violations as a result of this incident. Gauge: Humboldt Model: HS-5001 EZ S/N: 1599 Sources: Cs-137, 10 mCi; Am:Be, 40 mCi NC Tracking Number: 190019 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
ENS 5413226 June 2019 15:45:00The following was received from the North Carolina Radioactive Materials Branch via email: On 6/24/19, a patient underwent a Xofigo therapy treatment and did not receive the full dose as prescribed but had to return the following day to receive the full dose on 6/25/19. Due to the size of the patient and the fact that Xofigo doses typically arrive to the licensee in 10cc syringes, (in order) to accommodate the patient with the correct dose, the dose prescribed to the patient was split between two doses/syringes. On 6/24/19, licensee personnel delivered the first dose of 119.19 microCuries (Ra-223) which was approximately 50 percent of the prescribed dose. It was discovered after the patient was discharged that the remaining dose was still in the hot lab. The prescribing physician was immediately notified and the patient returned the following day, 6/25/19, and received the second dose of 114.5 microCuries (Ra-223). NC Radiation protection is currently investigation this incident and will follow up to close and complete this report." NC tracking number: 190021 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.
ENS 540453 May 2019 15:30:00The following information was received via e-mail: On 5/1/19 a patient had two (radioactive seed localization) RSL seeds (200 microCuries; I-125) implanted. The same patient returned the following day for an explant procedure. At that time, it was discovered that one seed was missing from the patient. The licensee confirmed through recorded imaging, consultation with the surgeon, patient surveys, and detailed surveys of the implant site and the explant site that the most likely area where the seed was lost was somewhere in between when the patient left the implant site and returned to the explant site the following day. North Carolina Radioactive Materials Branch has started an investigation that is ongoing at this time. This event is reportable per 20.2201(a)(1)(ii) - Lost, stolen, or missing licensed material in a quantity greater than 10 times the Appendix C quantities. North Carolina Tracking ID: NC 190016 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
ENS 5393515 March 2019 10:03:00The following report was received via e-mail: On 3/14/2019, NC Radioactive Materials Branch (RMB) was notified that a fixed nuclear gauge was stuck in the closed position (found that day). The reporting licensee had the vendor arrive on site, the same day, and repaired the gauge. Source Sr-90, 100 milliCuries North Carolina State Tracking ID: 190009
ENS 5396329 March 2019 11:01:00The following report was received from the North Carolina Division of Health Service Regulation via email: A prostate patient returned for a 30 day post treatment review and CT scan. Licensee Physics Group reviewed the Post Op Plan with the Intended Plan. It was found that when the Intended Plan was entered into the planning software, a dosimetrist entered an incorrect source strength into the planning system, causing the planning system to appear to be implanting weaker seeds than were being implanted resulting in an over dose of 20 percent. Event Date: 3/5/19 Discovered Date: 3/28/1 Prescribed dose: 164.85 mCi Administered dose: 213.15 mCi Isotope: PD-103. Target organ: Prostate Referring Physician notified on: 3/28/19 Patient notified on: 3/28/19 Effects/Outcome to the Patient: None anticipated. Physician will monitor patient for side effects. Notifications & Generic Implications: None. Corrective Action: Procedure revision. A reactive inspection was conducted today (by the North Carolina Division of Health Service Regulation). Following this entry into NMED we (the North Carolina Division of Health Service Regulation) would like to request the event be closed and complete. We (the North Carolina Division of Health Service Regulation) have concluded our investigation. NC Tracking Number: 190011 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.
ENS 539072 March 2019 21:02:00The following report was received from the North Carolina Division of Health Service Regulation, Radioactive Materials Branch via email: Licensee reports that an Industrial Radiography (IR) exposure device was unaccounted for during the 15 hours following work site activities on March 1st. The IR device was left unsecured the entire time until discovered the morning of March 2nd by the radiography crew that left it. The device (Spec 150; S/N: 1251) and source (72 Ci Ir-192; Model: G-60; S/N: AA0805) are secured and in possession of the corporate RSO (Radiation Safety Officer) at the time of this report. North Carolina Radioactive Materials Branch has initiated an investigation and will update this report for completion. NC Event Tracking ID: 190008 THIS MATERIAL EVENT CONTAINS A "CATEGORY 2" LEVEL OF RADIOACTIVE MATERIAL Category 2 sources, if not safely managed or securely protected, could cause permanent injury to a person who handled them, or were otherwise in contact with them, for a short time (minutes to hours). It could possibly be fatal to be close to this amount of unshielded radioactive material for a period of hours to days. These sources are typically used in practices such as industrial gamma radiography, high dose rate brachytherapy and medium dose rate brachytherapy. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
ENS 5389928 February 2019 11:11:00The following was received via email from the state of North Carolina: North Carolina Radiation Protection Branch (RMB) was notified on February 22, 2019, that a General Licensee could not account for two Microderm hand-held probes containing two sources each (25 micro Ci of Sr-90 and 100 micro Ci of Tl-204). RMB has been in communications with the General Licensee to ascertain whether or not the devices containing the sources have been returned to the vendor or are indeed lost. At this time, this cannot be verified and the RMB anticipates more information to follow on March 4, 2019. Additional details to follow to complete this event report. NC Event Tracking ID: 190007 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
ENS 5388118 February 2019 15:01:00The following was received from the state of North Carolina via email. A patient underwent an Interstitial OBGYN Implantation on 2/14/19, consisting of 45 seeds of Iridium 192 (5 seeds per strand; total of 9 strands) with an activity of 34.1 mCi. The morning of 2/16/19, the patient, still located at the licensee's facility, removed the strands containing the sources, placing some in the room's trash and some in the toilet and flushed the sources. Four strands containing 20 seeds were flushed and the remainder in the room were recovered by radiation safety. The licensee confirmed surveys of the patient and room. No other sources were found. The patient room had been isolated when licensee personnel found the patient with the removed sources. The licensee's maintenance crew determined that waste pipes from the room were accessible through confined space entry via manholes to sewer system only. The NC RPS (North Carolina Radiation Protection Section) dispatched an investigator as soon as it was notified, same day. The licensee will not be pursuing the collection of these sources due to the added hazards of attempting searches in a sewer system." North Carolina Event Tracking ID 190003 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
ENS 5368422 October 2018 14:22:00The following was received from the State of North Carolina by email: On 10/20/18, at 1757 EDT, the office RSO (Radiation Safety Officer) received a call from a crew working a project at Kings Mountain Compressor Station in Kings Mt., NC. The qualified radiographer assigned is Technician 1, with assistant Technician 2. Upon exposure of a 3 inch weld, the source did not retract when attempting to secure the RAM to end exposure. The crew immediately verified and re-verified and secured boundaries and called the RSO as required by operating and emergency procedures. The local RSO notified the CRSO (corporate RSO) of the event at 1803 EDT and proceeded to the site. (While) in route to the project site, Technician 4 was notified to go to the Charlotte office to get spare control cables for possible use in recovery operations. Upon arrival at approximately 1830 EDT, the RSO evaluated the site and boundaries and took action to move the source and collimator assembly to a better position to allow stacking of available sand bags in order to minimize boundary area for a more condensed and controllable area. During the movement of the exposure device, positive pressure was applied to the control to prevent the source from moving out of the collimator. Once the exposure device was positioned correctly, sand bags were placed over the source assembly to reduce exposure limits. During this operation, survey meters were used to verify radiation exposures. The radiation area was reduced to 30-35 feet. A conversation with the CRSO and calls with additional Applus groups were made in order to identify the closest source recovery tools and equipment in order to attempt recovery of the source. (Personnel) added another layer of area markings for control purposes. Contractor site personnel stayed clear of the area without issue during event. No exposure to the general public occurred. The recovery kit arrived on site at approximately 1030 EDT, 10/21/18. After review of available equipment, a recovery plan was discussed. Dosimetry, equipment operation, and proper calibrations were verified. All dosimeter pencils were verified at zero at the beginning of the event and monitored at stages during recovery. Actions were broken down in order to balance and reduce exposure to each individual and modified as necessary during event. The plan of action was to create a shielded dam with available lead shot and sand bags at the open end of the guide tube, with one bag directly in front of the tube to stop the source assembly at the most shielded position, with the others providing a shielded position for the capsule of the source assembly. The last sand bag on the collimator was left in position up until the last step. Two individuals were directed to quickly remove the last shielding bag while the other utilized an extended tong device to lift the collimator assembly directly upward to propel the source to the established dam of shielding. Survey meters were used to monitor this action to verify the source moved from the previous position to the created shielding dam. All dosimeter pencils were reviewed in order to determine who would be chosen to disconnect damaged connector and then another to make the connection to the functioning control cable. The first person pulled the connection out only far enough to disconnect the damaged connector. The second person performed the re-connection. The survey meter reading at the connection area was approximately 200 mR/hr during these steps. The time of exposure to perform these two events was estimated to be less than 30 seconds, which would have equaled approximately 1.6 mR of exposure to the hands of each individual. From the safe distance of the control cable, the source was retracted to the shielded position of the device and surveyed and secured. At this time, the exposure device and control cable have been returned to the office and tagged with damage tags so no one will use it. NC tracking number: 180043
ENS 535918 September 2018 17:44:00

The following information was received from the state of North Carolina via email: A patient being treated for liver tumors was prescribed to receive 47.6 mCi of Y-90 microspheres, but instead received only 11.9 mCi (about 25 percent of prescribed). The remainder was in the vial as residual.

Because this under-dosing was not due to stasis or emergent patient conditions, and the delivered dose was less than 20 percent of that prescribed, this constitutes a reportable medical event according to the 2016 version (9) of the NRC guidance for Y-90 microspheres. Source: Microspheres Radionuclide: Y-90 Manufacturer: Sirtex Medical Model: Sir-Spheres S/N: Aggregate Investigation is pending for the Medical Event. North Carolina Tracking Number: 180039 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.

ENS 5354310 August 2018 14:29:00The following information was received via email from the State of North Carolina: NC RMB (North Carolina Radioactive Materials Branch) was notified by an authorized service provider, Systems Service Corporation (License Number: 090-1071-1), that they had repaired a failed shutter on a fixed nuclear gauge located at International Paper located in Riegelwood, NC on 8/9/18. The shutter detent spring was corroded and dissolved due to its corrosive environment. The service provider removed the gauge and rebuilt it on site with another source housing. No known overexposures occurred during this event and it is unknown at this time whether the shutter was in an open or closed position. However, this investigation is still ongoing at the time of this report. No other generic implications at this time. No other notifications made. Source & Device Information: TBD. This report will be updated once RMB completes its investigation. North Carolina Report Number: 180034
ENS 5350817 July 2018 08:58:00

The following information was received via email. North Carolina (NC) Radioactive Materials Branch (RMB) is submitting the following reportable event: Radiography Camera Source Unable to Retract.

  Reportable per: 10 CFR 30.50(b)(2) & 10 CFR 34.101(a)(2)
  Event Date & Discovered Date:  6/25/18
  Date Reported to RMB:  6/26/18
  Location where event took place:  Stoneville, NC
  Reporting Licensee:  Applied Technical Services (ATS)
  NC License Number:  1510-1
  Radiography Camera Manufacturer:  QSA Global, Inc.
  Radiography Camera Model #:  Delta 880
  Radiography Camera S/N:  D5059
  Source:  Ir-192
  Source Activity:  71.4 Ci
  Source Manufacturer:  QSA Global, Inc.
  Source Model #:  A424-9
  Source S/N:  65909G

While conducting radiography shots at a water tank construction site, ATS radiography crew experienced a source hang up. Radiographers initially believed the cause to be a crimped guide tube due to source not moving in either direction. While maintaining a 2 mR/hr boundary, additional personnel were dispatched to the work site by ATS with additional shielding material and (the) RSO (radiation safety officer) who is responsible for source retrievals. Lead blankets were placed on the guide tube and the RSO determined that the guide tube was not compromised, kinked, crimped or otherwise damaged. Probable cause was determined to be in the control assembly. RSO unthreaded the guide from the outlet adapter and exercised the controls with no effect. Guide tube was reconnected and RSO began to troubleshoot the connection side of the camera by removing the housing from the connection to observe the cable while again exercising the controls. Cable would flex but was observed to be either wedged or pinned at the connector. During this process, it was observed that since the cable would not flex on the outlet side of the camera it was determined that extreme force on the controls side would not result in the cable being disconnected from the pig tail. The housing was reattached, and extreme force was used on the controls to break the cable free and the source was returned to its secured and shielded position. The RSO observed the control assembly crank did have more movement than usual, and root cause was determined to be debris from a damaged bearing that had moved down the control cable housing and locked up the controls. This equipment had quarterly maintenance and weekly inspections conducted on it. (The) controls were shipped to QSA for repair or disposal. All personnel involved in the source retrieval received doses well within annual limits for radiation workers.

RMB has concluded its investigation and consider this event Closed & Complete. No other agencies were informed of this event and no other generic issues identified. NMED Event ID: 180329 NC Tracking ID: 180029

ENS 5346119 June 2018 16:00:00The following information was received via E-mail: North Carolina Radioactive Material Branch (NCRMB) is reporting the following event: On 6/19/2018, Memorial Mission Hospital, Asheville (NC License, 0091-6) reported receiving two Biodex PET boxes containing F-18 FDG (fludeoxyglucose) from Cardinal Health, Asheville (NC License, 0794-7). Both boxes were delivered to Cardinal Health, Asheville via courier from Cardinal Health, Charlotte (NC License, 0794-1). Upon receipt of the boxes, Memorial Mission personnel performed surveys and wipes and noted the following contamination for Tc-99m on the boxes with the concentration of contamination being on the side handles of both boxes: Box 1: 88.96 kdpm/300 cm2 Box 2: 46.92 kdpm/300 cm2 No contamination was found inside either of the boxes containing F-18 patient doses and contamination was only on outside handles of both boxes. Memorial Mission confirmed that no further contaminated packages were received. Cardinal Health, Charlotte performed wipes and surveys of its work areas, courier vehicle and personnel. No contamination was found at this location with regards to this event. Cardinal Health, Asheville performed wipes and surveys of its work areas, courier vehicle and personnel. The courier at this location that delivered the two boxes to Memorial Mission Hospital is also a Pharmacy Technician. Removable contamination was found on this person's hands and cleaned. No other contamination was discovered at this location or the courier vehicle. No other notifications were made to any other agencies in NC. NCRMB was notified same day as the event. There are no other generic implications. NCRMB has dispatched an inspector to perform an on-site investigation. This report will be updated once more information is discovered, to include corrective actions and any other info needed to close and complete this report. Reporting Requirement: 10 CFR 20.1906(d)(1): Reports of removable contamination on package > limits in 10 CFR 71.87; removable contamination greater than limits specified in 49 CFR 173.443. NC Tracking Event Number: 180028.
ENS 5328223 March 2018 12:42:00The following information was received via E-mail: Licensee reports that on 3/22/2018 it was determined that a tube from an Everglo Tritium Exit sign was missing. The other three tubes were in the sign. The discovery was made as the sign was being prepared for shipment to disposal. At this time, there is no suspected excessive exposure to employees or members of the public. Licensee will follow up with additional information (as required) per 10 CFR 20.2201(b). When this report is received by the NC Radioactive Materials Branch, this event will be updated to complete the record." NC Event Tracking Number: 180013 See EN 53279 for corresponding report from licensee. 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
ENS 5325813 March 2018 12:27:00

The following information was received from the state of North Carolina via email: A North Carolina licensee reported the receipt of a package exceeding the limits as defined in 10 CFR 20.1906(d)(2) and 10 CFR 71.47; direct contact readings of the package greater than 200 mR/hr. Origination of the package was: Laguna Verde Power Station in Mexico and the final carrier: Tristate, has been notified. Licensee reports that the package exceeding the limits was not designated as Exclusive Use on the bill of lading. At this time, it appears to be a manifest error on the part of Laguna Verde Power Station, Radiation Protection. Licensee followed their internal procedures for the handling of packages designated as Exclusive Use when initial surveys of the received package exceeded the limits in 71.47. Licensee reports that carrier Tristate; handles all shipments to the licensee's location as Exclusive Use.

At this time, no public health and safety issues have been identified. It was determined through initial licensee surveys that the driver for this shipment did not receive a dose exceeding the limits and no other product was being transported or offloaded with this shipment.

NC Radiation Protection Section has initiated an investigation and will be responding on-site. Follow up details will be forwarded to the NRC as appropriate following the outcome of this investigation.

ENS 5302518 October 2017 14:41:00The following information was received via e-mail. The licensee discovered that the shutter to a fixed nuclear density gauge was missing on 9/21/17 during routine leak tests. Prominent barriers were immediately put in place around the fenced area containing the gauge to further cordon off the area to prevent any access to the area. Three days prior to discovery, the licensee performed routine cleaning in which the shutter was observed in place at that time. The gauge is located on top of winding equipment 6.5 feet high, located inside of a fenced area. The fenced area provides an additional 4 feet from the gauge separating areas where personnel may traffic on the ground. The radiation beam for the gauge is pointing down from its location and travels about 6 inches to the target plate. By facility design, placement of the gauge includes additional barriers and fencing, access to the gauge by any person is restrictive and following interviews with the licensee, no exposures are suspected to have occurred due to the faulty shutter. The manufacturer completed repairs to the fixed gauge on 10/6/17. Gauge Information: NDC Amersham Model # 103, Serial # 11302. Source Information: Am-241, 150 mCi, QSA Global, Inc. Model # AMC.P6, Serial # 5244AR. NC Tracking Number: 170042
ENS 5292524 August 2017 22:09:00

The following information was obtained from the state of North Carolina via email: North Carolina Radioactive Materials Branch (RMB) was notified on 8/24/17 at 7:58 PM (EDT) that a portable nuclear gauge went missing at around 6:00 PM at a job site at Ten-Ten Road in Garner, NC 27603. Licensee: ECS Southeast, LLP License Number: 092-0253-1 Gauge Manufacturer: Instrotek Xplorer Model #: 3500 Serial #: 3194 The gauge contains 11 milliCuries of cesium-137 and 44 milliCuries of americium-241: beryllium. The gauge was not trigger locked and not locked in its original carrying case at the time it went missing. RMB is investigating the incident and working with local authorities to develop a press release. Local law enforcement and the FBI have been notified. Follow-up information will be provided to the NRC as this investigation is ongoing.

  • * * UPDATE AT 1058EDT ON 08/25/17 FROM TRAVIS CARTOSKI TO S. SANDIN VIA EMAIL * * *

NC Radioactive Materials Branch (RMB) would like to report that the missing gauge has been found this morning 8/25. Three members of the RMB were dispatched last night to initiate an investigation and reconvened this morning to continue. The gauge appeared to have no damage and is being returned to the manufacturer for verification. Surveys were taken on and around the gauge once it was found and all surveys appeared normal indicating the sources were still intact within the gauge. Through interviews of personnel on-site, it was determined that source rod was never extended from when the gauge went missing to when it was found. An on-site construction worker found the gauge unattended yesterday afternoon and secured it until this morning. RMB is continuing its investigation from a compliance stand point. Further details will be provided to satisfy the details of this incident following conclusion of this investigation. Notified R1DO (Kennedy) and NMSS Events Notification and ILTAB via email. 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

ENS 5284611 July 2017 12:08:00The following report was received from the North Carolina Department of Health and Human Services via email: North Carolina Licensee ECS Carolinas, LLP, License Number 092-0253-1 reported that a Troxler Model 3440, S/N 24665 Moisture Density Gauge had been damaged on July 10, 2017 at a construction site in Chapel Hill, NC. The gauge contained 8 mCi of Cesium-137 and 40 mCi of Americium-241. An approved technician backed up a company vehicle over the gauge. North Carolina Radiation Protection immediately dispatched an inspector on site to perform a reactive inspection same day. Event Date and Notification Date: July 10, 2017. Licensee had cordoned off a 15+ foot barrier around the vehicle and the gauge. Surveys taken at various distances from the gauge and on contact confirmed that the sources were intact and shielded in the gauge. The gauge sustained minimal damage to the guide rod and the source rod was not extended at the time of the incident. No other local or federal authorities were contacted for this event. The gauge was returned to the manufacturer for repair or disposal. A 30-Day Report is pending from the licensee and follow-up information will be provided. NC Event Report Tracking Number: 170026. Event reportable due to: 10 CFR 30.50(b)(2)(ii).
ENS 5282223 June 2017 11:37:00

The following information was received from the State of North Carolina via email: On June 22, 2017 at (1130 EDT), North Carolina Radiation Protection Section (RPS) was informed by the Radiation Safety Officer for Hospira, Inc. (Pfizer), Rocky Mount, NC (License 064-0969-1) that they were experiencing an issue involving their Wet Shielded Irradiator (Nordion Model JS-8900, Serial Number IR-183, approved for 4,800,000.00 Ci of Co-60). RSO stated that during routine maintenance checks the Source 1 Rack of the irradiator would not trip the down switch to confirm the source rack was in the down position on the control panel and that they were following emergency procedures. Nordion was then contacted by the licensee to obtain assistance. RPS inspectors were immediately dispatched to the licensee's site. Once on site, RSO informed RPS that visual confirmation was made of source position via hydraulic cylinders that were fully extended, comparison of cable tightness on roof was observed, and that no indication of radiation in the vault was detected; all leading to the unconfirmed indication that the source rack had moved to the down position. With the assistance from Nordion, Hospira staff were able to initiate bypass procedures and gain access to the vault where confirmation was made that the source racks were in the down position. Nordion advised that a faulty down position switch was the cause for the failure. Switch was repaired on site by Hospira engineers, same day. Following repair, Hospira personnel cycled the sources which were brought up into position for one sterilization cycle and then the sources were brought down to test the position sensor. The test was successful, as indicated by the down position indicator lamps and screen on the operator's panel. Nordion staff was informed of the successful test and Hospira staff continued procedural tests to confirm full functionality. After confirming cycling up and down of the source racks, Hospira personnel performed full monthly QA check before resuming operations. 30-Day report is pending to RPS.

  • * * UPDATE ON 8/2/2017 AT 1042 EDT FROM TRAVIS CARTOSKI TO DONG PARK * * *

The following information was received from the State of North Carolina via email: We have completed our investigation and have no further information to provide in this event report. We would like to request (NMED) Event 170315 be Closed & Complete. Notified R1DO (Lilliendahl) and NMSS Events Notification via email.

ENS 527232 May 2017 16:29:00The following was received by the state of North Carolina by email: On 5/1/2017, licensee received a 5 gallon shielded drum containing 8 Cf-252 sources with a total activity of 148 MBq (4.0 mCi). Shipment of the sources originated from E&Z Isotope Products, License Number: 1509-19. Shipment was made through (a common carrier). The drum was labeled Yellow-III and had a TI (Transport Index) of 9.4. The licensee followed procedures for receiving and securing radioactive materials shipments. Once the drum was secured, the licensee noted surveys of the drum were higher than expected: Side survey of the drum was 18 mrem/hr (gamma) on contact and 90 mrem/hr (neutron) for a total of 108 mrem/hr. Top survey of the drum was 40 mrem/hr (gamma) on contact and 400 mrem/hr (neutron) for a total of 440 mrem/hr. Bottom survey of the drum was 3 mrem/hr (gamma) on contact and 20 mrem/hr (neutron) for a total of 23 mrem/hr. The drum was then shielded with polyethylene and cadmium. Upon resurveying the drum to confirm readings the following differences were noted: With the drum upright and the neutron detector on top of the drum, the reading was 400 mrem/hr. With the drum on its side and the neutron detector in contact with the drum, the reading was 440 mrem. Wipes of the drum were then taken and the results were (less than) MDL (Minimum Detectable Levels). The drum was then opened for further inspection by the licensee. It was noticed that a polyethylene bag containing sources was sitting on top of the shield plug and was only about 2 inches from the top of the drum and not covered by any shielding indicating that the sources were not shielded correctly prior to shipment. The sources were in-processed by the licensee and are still in the licensee's possession (quantity and activity as approved per their NC License). North Carolina Radiation Protection, (the common carrier) and E&Z Isotope Products were notified of the event on 5/1/2017. NC Radiation Protection is actively investigating this event at this time. Report ID Number (NC): NC170020 At this time the cause and corrective action is to be determined. NC Radiation Protection will be reaching out to E&Z Isotope Products and (the common carrier) for more information. The licensee was authorized to receive the materials in the quantity and activity they received.
ENS 5258028 February 2017 14:37:00The following information was supplied via email from the State of North Carolina: On 2/27/2017 the North Carolina Radiation Protection Section (RPS) received the following notification from Duke University Medical Center, License number 0247-4. A possible Medical Event occurred at Duke University Medical Center on February 24, 2017 involving Y-90 microspheres during a liver embolization procedure. Duke personnel reported to North Carolina Radiation Protection Section (RPS) on February 27, 2017 of the event meeting the reporting requirements for a Medical Event as dictated in NRC Licensing Guidance, Rev. 9 under: Medical Event (ME) Reporting: The licensee shall commit to report any event, except for an event that results from intervention of a patient or human research subject, in which: the total dose or activity administered differs from the prescribed dose or activity, as documented in the written directive, by 20 percent or more, except when stasis or emergent patient conditions are documented and resulted in a total dose or activity administered that was less than that prescribed; At this time, the details provided by Duke University Medical Center for this ME are as follows: Delivered dose was 94 percent higher than the prescribed dose in the Written Directive to the treatment site. The apparent cause appears to be an error in reading the prescribed radioactivity (in GBq) before converting to the administered activity (in mCi), indicating operator error that occurred in the radio pharmacy at Duke University Medical Center. RPS has dispatched an investigator to perform a reactive inspection at Duke University Medical Center. This investigation is ongoing and RPS will have additional information to complete this report. The State on North Carolina does not know if the patient has been notified of the received dose being higher than the prescribed dose. 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.
ENS 5256017 February 2017 12:20:00

The following report was received from the State of North Carolina via email: On 2/15/2017 Duke University reported to the NC Radiation Protection Section (NCRPS) a leaking source:

U-235 3 microCuries 1.5 grams S/N: D16156

This source was loaned to Duke University through Los Alamos National Laboratory (LANL) for experimentation, research, education and calibration purposes. NCRPS personnel were dispatched to conduct a reactive inspection on 2/15/2017. Through interviews with Duke personnel it was determined that during an experiment the source integrity was compromised and assumed to be leaking. No direct wipe of the source was taken. The source was packaged to prevent contamination and then isolated for pending disposal. It was also determined that the actual breach of the source occurred on 2/11/2017. Given the lapse of when the source was compromised and when Duke Radiation Safety Office was notified it is apparent that established Duke SOPs were not followed. Duke personnel and researchers believed to have been exposed to the leaking source had lung scans performed on 2/15/2017, in which all came back indicating no exposure. Duke personnel accompanied by NCRPS staff began testing for contamination of the affected area and surrounding areas due to the compromised source.

On 2/16/2017, Duke personnel again notified NCRPS that contamination was discovered outside of the anticipated areas where contamination was suspected. On 2/16/2017, NCRPS personnel continued the reactive inspection. The scope to the surveys was expanded to now cover high traffic areas, vehicles of the individuals involved, bathrooms and other areas where potential contamination from the leaking source may have been in. Testing of these areas for contamination is ongoing at the time of this report. For the identified personnel directly associated with the leaking source, surveys and wipes were expanded to their residences. One residence, that of a Duke Physicist Researcher, presented contamination on a toilet seat which was decontaminated and re-surveyed and re-wiped and the results confirmed the decontamination. Other areas of the residence were surveyed and at the time of this report all results indicate no further contamination. Additional researchers identified on 2/16/17 to have been involved with the leaking source, were also scheduled to have lung scans on 2/17/2017. Additionally, Duke University decided to compound testing to include urinalysis and possibly bloodwork at the advice of REACTS. At this time, it is believed that contamination due to the leaking source has been contained and no members of the public have received radiation exposures. To date, the highest reading in proximity to the source on Duke University's property was 7000 CPM and 4280 DPM.

On 2/17/2017, NCRPS in conjunction with Duke personnel reconvened to continue to complete the expanded surveys and wipes of all possible suspected areas and to conduct additional interviews with Duke personnel to rule out any chances of additional affected persons. Currently, this is an ongoing investigation and this event will be updated as additional details are received. North Carolina Event Report 2/17/2017.

  • * * UPDATE FROM TRAVIS CARTOSKI TO HOWIE CROUCH VIA EMAIL 1436 EST ON 3/3/17 * * *

The state of North Carolina submitted their final report for the Duke incident via email: Radiation Protection Section - Duke Incident Report March 3, 2017 Friday 2/10/2017: U-235 Source was removed by RES (researcher) D from storage located at Triangle Universities Nuclear Laboratory (TUNL) and taken to the Upstream Target Room (UTR) at the High Intensity Gamma-ray Source (HIGS) facility. Saturday 2/11/2017: RES A utilizing the U-235 sealed source for research compromised the integrity of the source by bending the corners of the source to fit in a target holder resulting in the contamination of a researcher's hand (RES A) and work surface. The sealed source of a water insoluble form of U-235 with an activity of 3 micro curies containing a total of 1.5 grams of powdered U-235 with the majority still inside. This took place in the UTR located in HIGS and at no time was the source exposed to the accelerator beam. RES A informed RES D of the compromised source where it was confiscated by RES D. Both the RES A & RES D decontaminated their hands and work surfaces suspected to be contaminated. RES A expressed their concern over the leaking source to RES D, this concern was dismissed by RES D who did not report the status of the source or the possibility of contamination as dictated in Duke University established procedures. No contamination surveys were reported as performed for the compromised source or work surface areas at the location of UTR in HIGS. The compromised source was contained (bagged), sealed and moved back to storage located at TUNL by RES D following transport to Physics where an attempt was made to repair the source also by RES D. Surveys at Physics on the contained source indicated no contamination by RES D after resealing the source. At no time were gloves or any Personal Protective Equipment (PPE) reported to be utilized by either RES A or RES D before and after the source was compromised. Researchers and Duke personnel failed to follow established procedures which dictate that any damage to a radioactive source or suspected contamination be immediately reported to Duke Radiation Safety, RSO (Radiation Safety Officer) or RSM (Radiation Safety Manager) 1 or RSM 2. Monday 2/13/2017: RES D notified RSM 1 of the possibility of leaking compromised source and requested the source be detected for possible leakage. Again, the possible incident was not immediately reported. Tuesday 2/14/2017: RSO was notified by RSM 2 (who overheard the discussion between RES D & RSM 1 on 2/13/2017) about the possible incident that occurred on Saturday 2/11/2017. This notification should have come from any of the researchers involved (RES A, B, C & D or RSM 1). Wednesday 2/15/2017: Radiation Protection Section (RPS) was called by RSO Wednesday morning and informed of a possible incident at Duke University. SC (North Carolina Radiation Protection Section Chief) and HP (North Carolina Radiation Protection Section Health Physicist) 1 were dispatched to conduct a reactive inspection. RPS led a fact finding discussion with Duke personnel (Res D, RSO, RSM 1, RSM 2, LW (Laboratory Worker) 2 & LW 3) and international researchers (RES A, RES B & RES C) to establish the chain of events from 2/10/2017 to present. Following these discussions, RPS determined: 1. The investigation will remain open pending a follow up report from Duke University regarding the compromised source and; 2. That any contamination had been contained at UTR in HIGS by Duke personnel the verification of which; to be included in the follow up report. Duke Environmental Safety Office then began surveys of the affected areas of UTR at HIGS due to the compromised source and also to verify no further contamination. RES A, RES D & RSM1 were identified as being in contact with the source and were evaluated for contamination exposures by lung scans at TE (Technical Experts) 1. Results indicated no inhalation occurred. Because of the insoluble nature of the isotope, it was advised by TE 1 that no further bioassays (urine or fecal) were necessary. SC notified the Division of Public Health (DPH) of the Duke University incident. Roles and collaboration efforts were discussed during this time. The incident was also discussed with Division of Emergency Management (DEM). Thursday 2/16/2017: RPS was notified at Thursday morning that Duke personnel were discovering contamination found outside of UTR at HIGS. RPS (SC, HP1, HP 2, HP 3 & HP 4) was dispatched again to Duke. Additional areas at Duke were found to be contaminated at Free-Electron Laser Laboratory (FELL). RPS requested that Duke personnel immediately expand surveys for possible contamination well beyond original surveyed areas to include: bathrooms, stairwells, hallways and other high traffic areas at FELL. This was necessary to establish a high confidence that contamination was contained to Duke property/facilities. HP 1, HP 2, HP 3 & HP 4 observed all surveys conducted by Duke for his incident investigation. It was during these observations that many common radiation safety practices were not adhered to including: a. Several chances for cross contamination of the samples could take place due to the technique employed (crossing of one hand for samples taken and the other hand for sample collections), witnessed by HP 1. b. While licensee personnel were taking surveys of personal items and surveys of hands and shoes, it was observed that the detector surface was held at an angle which could allow contaminant particles to contaminate the survey window of the detector, potentially compromising the detector to make accurate survey determinations, witnessed by HP 1 & HP 2. c. Through observations, it was discovered that researchers consumed beverages in a radiation use area which lead RPS to the possibility that ingestion was now a possible exposure pathway, witnessed by HP 2. An additional 2 researchers (RES B & C) and a laboratory worker (LW 1) were identified as possibly having contact with the source on the 2/11/2017 (total of 6 people). RES B & C were also scheduled for lung scans on Friday 2/17/2017 at TE 1. All individuals that may have come into contact with the source (RES A, RES B, RES C, RES D, & RSM 1) were interviewed to map their routes from Saturday 2/11/2017 to present, with the exception of LW 1 who was not available for interview due to being unreachable via phone, email or page. LW 1 was finally contacted on Friday 2/17/2017. Based on those interviews, high risk areas were surveyed utilizing an alpha detector to include: initial laboratory areas, immediately surrounding areas, personal items (cell phones, wallets & shoes of RES A, B, C, D & RSM 1) and the vehicle of 1 RES D were completed and indicated no contamination. Duke personnel performed wipe surveys of these items and at the time indicated no contamination. RPS requested that Duke extend surveys to include the residences of those identified to have come into contact with the source to include: hotel rooms of 3 researchers (RES A, B, & C) who are visiting international researchers, and the residences of RES D & RSM 1 (LW 1 still unavailable at this time). All surveys indicated no contamination with the exception of the residence of RES D. That contamination was found on a toilet seat of the residence, remediated by Duke personnel and resurveyed and indicated no contamination. All other areas of RES D residence surveyed indicated no further contamination. Public Health Preparedness and Response (PHP&R) supported RPS on site for the investigation. Occupational and Environmental Epidemiology Branch (OEEB) was consulted for additional recommendations for bioassays and Duke personnel was made aware. Durham County Health Director and DPH leadership were informed and through conference call, determined a plan of action for public health. Conference call with Duke VP of Communications, Department of Health and Human Services (DHHS) Communications Office, RPS and PHP&R was held to draft public and employee messaging. United States Nuclear Regulatory Commission (USNRC) was consulted by RPS on the details of this incident to this point. Friday 2/17/2017: RPS continued its investigation with Duke Friday morning. Lung scans for RES B & C were conducted at the location of TE 1 and indicated negative results. LW 1 was interviewed and was eliminated from the list of possible contaminated personnel, as they did not have any contact with the source from when the incident took place (final total of 5 potentially exposed people). Surveys were expanded to areas known to be frequented by the researcher (RES D) whose residence was found to be contaminated on Thursday 2/16/2017. A keyboard in the researcher's office was found to be contaminated, contained by Duke personnel and removed for isolation. All other areas frequented by this researcher were surveyed and indicated no further contamination. An additional 10 personnel (ancillary, housekeeping, students, faculty, engineers) were identified as having frequented the affected areas involved with this incident. These individuals were interviewed and were found to not have had contact with any of the contaminated areas or any involvement with the compromised source. At this time, RPS generated a report to the USNRC under the assumption that a 24-hour report was to be required. This was necessary in assuming a reporting requirement for unplanned contamination and assuming a worst case scenario as the investigation was still ongoing. Additional consultation was provided to RPS from TE 3 & TE 4 with regards to the compromised source to add perspective, that, should one individual were to consume the entire U-235 source, that person would receive 2 years of natural background radiation upon ingestion. Additionally, given that the source contained an activity of 3 microCuries, it would not have exceeded the threshold for Allowable Limits for Intake (ALI). Training for those involved with this incident was also reviewed. During this review, it was confirmed that all individuals involved in this incident received Radiation Safety Training. This training specifically indicates that any damage to radioactive sources, suspected contamination and unexpected radiation exposures be reported immediately. The fact that this was not reported on 2/11/2017 appears to be in violation of Duke University Procedures. Other Procedures were reviewed with regards to the compromised source. Specifically, Duke's own customized procedures tailored for this source, indicated that the source was to be tested for leakage every six months. Duke could not provide documentation that these leak tests took place and freely admitted that they were not conducting these tests for this source. As surveys were continued to be expanded it was discovered that equipment used to reseal the compromised source on 2/11/2017 was found to be contaminated at the location in Physics. This equipment was remediated and removed. Additional surveys expanded out of Physics (door leading to Physics & hallways leading to Physics room) were conducted to confirm containment of any contamination and the area cordoned off pending results. Additional surveys and observations made where the source was stored at TUNL and no further contamination was detected at this location. Through interviews by HP 1 & HP 2 with Duke personnel conducting the wipe surveys for areas suspected to contain contamination, it was discovered that techniques utilized were suspected as inadequate (samples exposed to ESD (electrostatic discharge), improper lighting, temperature control) to provide reliable results and further put into question the capabilities of the detector equipment via Liquid Scintillation Counter (LSC) to provide reliable results. RPS requested that Duke personnel utilize another reliable LSC and re-run all samples up to this point for this incident and any future samples taken in this investigation. The results of which are pending. Duke personnel decided to conduct Whole Body (WB) scans for RES A, B & C to compound the Lung Scans previously performed for these individuals. The results for the WB scans were negative. This was necessary as these individuals were scheduled to depart to their home countries on Saturday 2/17/2017 and this was the most reliable additional testing that could be conducted in the time available. Urine samples were also taken for bioassays from RES A, B & C. RSO has reached out to the Japanese Atomic Energy Agency Radiation Safety Officer to inform him of events and discussed testing and results of the researchers from Japan. Additionally, Duke personnel committed to conducting 24-hour urine bioassays and possible blood analysis for Duke personnel involved in this incident. The results of which are pending. The decisions to conduct further tests were made in consultation with TE 1 & TE 2. An exit meeting was conducted by Radiation Protection Program with Duke University personnel in which preliminary items of Non-Compliance were discussed. A corrective action plan was presented which was acceptable to Radiation Protection Program as next steps: 1. Shut down the High Intensity Gamma Source (HIGS) operations within the Free Electron Laser Laboratory (FELL) until March 27, 2017. During this time DU (Duke University) will be modifying procedures and working toward needed improvements. On 2-18-17 this commitment had been upgraded by the new Director of FELL and Triangle Universities Nuclear Laboratories (TUNL), to an indefinite suspension of operations in HIGS using radioactive targets. HIGS is where the incident occurred using radioactive targets. 2. (A Duke Radiation Safety Program (DRSP) Health Physicist will temporarily manage the laboratory) until a permanent replacement may be found. DRSP will maintain a larger footprint and role in operations within the facility while improvements are being made. 3. DRSP is considering hiring a consultant to help with procedural improvements and restore safety culture beyond implementing their own resources. 4. Duke University has committed to begin leak testing all sealed sources prioritizing custom radioactive sources. 5. Duke University leadership has committed to providing DRSP with funding and resources needed to upgrade radiological analysis equipment and facilities. 6. DRSP has suspended online training practices and have committed to face-to-face training with all new researchers emphasizing safety practices and procedures. NOTE: This report was submitted March 3, 2017. RPS is continuing its investigation until all deficiencies identified in this report have been corrected to the satisfaction of RPS that Duke University is in compliance. Notified R1DO (DeFrancisco), NMSS EO (Collins), and NMSS Events Notification (email).

ENS 5250020 January 2017 15:04:00The following was received via E-mail: The North Carolina Radioactive Materials Branch (RMB) is submitting a report of a possible Medical Event reportable under 10 CFR 35.3045(a)(2)(i). Specifically, a dose was delivered to a patient with an effective dose equivalent (50 rem) to an organ through the administration of a wrong radioactive drug containing byproduct material. The RMB received the report of the possible Medical Event on 1/19/2017. NC Licensee Duke University, License 0247-4, reported to the RMB that around 1300 EST on 1/19/2017 a patient scheduled for a thyroid uptake scan in the Diagnostic Nuclear Medicine Department was incorrectly identified and received an oral dose of 2.0 mCi of Iodine-123 instead of the intended dose of 5-12 microCi of Iodine-131. An investigation was held on 1/20/2017 with members of Duke University to include the individual that delivered the incorrect dose to the patient. Following a review of the licensee's current procedures, it was noted that there is a minimum of two methods of patient verification prior to the administration of any diagnostic radioactive drug to any patient. An interview was conducted with the CNMT (Certified Nuclear Medicine Technologist) that delivered the incorrect dose and they freely admitted to not following the proper protocol which consists of confirming the Name and Date of Birth of the patient. Other factors may have attributed to this misadministration to include the volume of patients being treated that day and that there were two patients present that day with very similar first and last names. The patient with the similar name received the proper dose for their procedure. Following interviews with Duke personnel, it was determined that the CNMT received the proper training to adhere to this two factor authentication as dictated by internal procedures and was authorized under an approved AU for such uses. At this time, it appears the cause for this misadministration is due to human error. This investigation is ongoing and more details are to follow to update this report. Several records were requested of the licensee to include a dose assessment to verify the EDE of 50 rem or any excess of 50 rem delivered to the organ. The licensee is compiling it's 15 Day Report and will be providing it to the RMB as required by the Rule. Following receipt of that report, this event will be updated. 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.
ENS 521555 August 2016 10:37:00The following was received from the North Carolina Department of Health and Human Services via email: General Licensee discovered a defective shutter on one of its fixed gauges while performing leak tests. The shutter was discovered as being completely removed and the gauge remains in the open (source exposed) position. Per the licensee, during its previous leak test in May 2016, the shutter was intact on the gauge at that time. From the time of the previous leak test to present it is unknown how long the shutter was removed from the gauge. Per the licensee, the gauge is positioned with the radiation exposure pointing downward toward its product line where density measurements are determined. Currently, the licensee's operations are continuous and the gauge remains in the open position during operations to support business output. Discussions with the licensee were held concerning potential radiation exposures to members of the public and its employees. It was determined that due to the design of the licensee's manufacturing process it would be incredibly difficult for anyone to safely come within the immediate vicinity of the gauge with the defective shutter. An entire shut down of the licensee's manufacturing process would have to occur for anyone to gain any safe method of access to the defective gauge, in which the licensee stated, has not occurred since the most recent leak test when the defective gauge was discovered. This in an ongoing investigation and more details will be forthcoming. Source Material: Am-241 North Carolina Item Number: NC160025
ENS 5225722 September 2016 17:56:00The following report was received from the North Carolina Department of Health and Human Services via email: The Agency (North Carolina Department of Health and Human Services) was notified of service contract reciprocity 0003-R Ronan to arrive at NC (North Carolina) Licensee Chemours in Fayetteville on 9/21/16. Ronan to work on a Ronan SA-1, Gauge SN:M1713, Cs-137, 20 mCi (decayed to approx 10 mCi) with a stuck shutter. (The North Carolina Radioactive Materials Branch Health Physicist) went to Chemours 0109-7 to conduct a reciprocity inspection, and conducted an investigation regarding (Chemours) failing to notify the Agency (North Carolina Department of Health and Human Services) of a stuck shutter on a radioactive gauge. The stuck shutter was identified during scheduled leak test and shutter testing by Chemours workers in June, 2016. This was confirmed with the RSO (Radiation Safety Officer). Shutter was in the open position. No members of the public or workers were at risk of exposure (due to facility design). Source: Cs-137 Activity: 0.020 Ci Manufacturer: Ronan Engineering Model Number: sa-1 Serial Number: m1713 NC Item Number: NC160030
ENS 5173515 February 2016 08:47:00

The following report was received from the State of Georgia via email: The following was reported to the State of Georgia on February 15, 2016. The patient was prepped for the delivery of doses of 18 and 21 Gy to 14 subcentimeter brain metastases with Gamma Knife stereotactic radiosurgery. The frame adapter was placed on the patient's stereotactic head frame by a Gamma Knife trained registered nurse, supervised by Authorized Medical Physicist (AMP), and Authorized User (AU). After five of the planned 14 lesions were treated, the patient was given a break in order to use the restroom and for additional medication. During this treatment break, the AU and AMP entered the room to release the patient from the restraining device and assist (the patient) to the rest room. It was at that point that it was discovered that the restraining device was locked, but not in the correct position. The displaced distance was measured and determined to be a maximum discrepancy of 2 cm in one plane. The AMP and AU applied the displacement to the treatment plan to determine which areas were treated and which were not. It was determined that a potential misadministration had occurred.

The RSO (Radiation Safety Officer) was notified to discuss the course of action. Following discussions with the AMP, AU, the medical director, the prescribing physician and radiation safety officer, it was decided that there was a potential medical event or misadministration as defined in 391-3-17-.05(115)(a)3 or 391-3-17-.05(115)(b). The cause of the event is uncertain at this time. The head restraining device should not have been able to be secured unless it was in the proper position. An investigation is ongoing and additional information is being sought. The patient received an unintended radiation dose to normal brain tissue, however, it was determined by the authorized user in consult with the medical physicist that little clinical effect will be demonstrated due to this inadvertent exposure. The patient, the patient's family and the patient's referring physician were informed of the event. After extensive discussions, it was agreed by all parties that the treatment would be completed to ensure that the correct dose is delivered to the remaining target areas. This is all the data available at the moment. A reactive inspection is currently underway and updates are soon to follow. 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.

ENS 5125122 July 2015 15:20:00The following report was received via e-mail: 1. A patient received an (Ir-192) HDR treatment using a skin applicator on the nose. This treatment is used to treat skin cancer. 2. The physician's written directive specified a dose to the tumor volume, and a maximum tumor dose of 130 percent of the prescribed dose. The total dose was delivered in 8 fractions. 3. The patient's course of treatment proceeded to conclusion. On recent follow-up exam, the patient's skin reaction was more than usual for this type of treatment, so the physician asked physics to review the plan. 4. This review indicated the tumor volume maximum dose exceeded the prescribed 130 percent by more than 50 percent. The date, time, and dose prescribed/received were not given in the report. 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.
ENS 5125222 July 2015 15:20:00The following report was received via e-mail: An incident has come to light at (the licensee's) Conyers clinic. A patient was treated with a vaginal cylinder at the beginning of July, 2015. The treatment was delivered in 3 fractions. On a recent follow-up exam, the patient presented with a single mark on the skin of the upper inner thigh on both legs. The radiation oncologist felt these marks were consistent with radiation dermatitis. A review of the patient's treatment plan and treatment records showed no errors had occurred. (The licensee's) current thinking is that the only plausible explanation is that the catheter which contains the source wire was not securely locked inside the vaginal cylinder and partially slipped out during treatment.. If this occurred, the most proximal dwell position could have fallen on the skin of the upper thigh. (The Georgia Radioactive Materials Program) is continuing to investigate. 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.
ENS 5076526 January 2015 17:09:00The following report was received from the State of Georgia via email: Georgia Radioactive Materials Program discovered through a Law Enforcement List Server that 2 Co-57 sources and 1 Cs-137 source (what appear to be Dose Calibrator Sources as indicated in the example photo provided by LE) were stolen from a vehicle at or around Atlanta Hartsfield Airport. Activities of the sources are: The 2 Co-57 are 2.47 mCi and .365 mCi sources. The Cs-137 is a .232 mCi source. The individual transporting the sources was from Florida (Florida Department of Radiation Services). Florida Radiation Control has been notified and Atlanta FBI has been notified. Updates to follow when more information is available. State of Georgia Event Report 1-26-2015. 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
ENS 4926912 August 2013 17:11:00

The following Georgia Agreement State report was received via email. Event Description: Patient was scheduled for an I-131 prescribed dose of 100-150mCi for the treatment of Thyroid Carcinoma. The patient instead was administered a dose that deviated 20% lower than the prescribed dose. This incident was reported to the (Georgia) State per Rule 391-3-17.05(115)(a)1.(i): 'A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and either (i) The total dose delivered differs from the prescribed dose by 20 percent or more.' The State will provide the corrective action information when provided by the licensee. GA State Report ID: CTS 71850 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.

  • * * UPDATE FROM TRAVIS CARTOSKI TO HOWIE CROUCH VIA EMAIL ON 8/20/13 AT 1240 EDT * * *

A sodium iodine I-131 thyroid ablation treatment was ordered as a NaI I-131 whole body scan resulting in a patient receiving a diagnostic dose of 5 mCi of NaI (I-131) instead of the therapeutic dose of 50 mCi of NaI (I-131).

Both the referring physician and the patient were also informed of the misadministration of the 5 mCi I-131 dose for the whole body scan on August 7, 2013 in light of the confirmed order for an I-131 thyroid ablation. The order verification process was reviewed with all involved staff members and an extensive review of the process was begun.

Nuclear Medicine, like all diagnostic services, requires verification of the order for services. This verification must be in the form of a written order or an electronic authenticated order. On August 1, 2013 Piedmont Hospital Atlanta implemented EPIC, a new electronic medical record (EMR). The orders verification process changed a bit, because Piedmont Physician Groups could place an order within the EPIC environment (EPIC Physicians) and have them electronically authenticated, with e-signature and a time stamp. Physicians not in the EPIC environment (non-EPIC Physicians) could still schedule services through scheduling by providing a written order. Once scheduling had received a written order, the ancillary orders process would produce an order that looked just like the order produced by an EPIC physician, but the chart would have a paper clip to signify that it was a non-EPIC Physician order.

During the first week of the EPIC implementation, many of the orders that were transcribed by the scheduling services department did not have the attachment of the original written order. This information came to light during the first few days of go-live but not all end users were informed on the issue. In this particular case, the patient's order was requested by a non-EPIC physician, as an I-131 whole body scan. The order was transcribed by scheduling , and as of August 7, 2013, the original order was not scanned into the chart. The order in the chart appeared to be an EPIC Physician order. Based on the information known at the time, the order for an I-131 whole body scan was verified and the patient was dosed and instructed to return on Friday August 9, 2013 for imaging.

On August 8, 2013, a copy of the original order was scanned into the patient's record. The order contained more detailed information concerning the reason for the referral to nuclear medicine. This information would prove to be vital in determining the actual course of treatment requested by the referring physician.

On Friday August 9, 2013, the patient returned for the whole body scan, but due to a downed system at the hospital the patient was referred to the Piedmont West Imaging Center to complete their test. While preparing the report template in PACs (Name removed), noticed that the patients chart had a paper clip icon but the documentation that she had received from the hospital Nuclear Medicine department only had an EPIC Physician order. (Name removed) opened the original scanned order for an I-131 whole body scan and discovered that within the comments section of the note that the Authorized User was referring the patient for an I-131 thyroid ablation. The office was contacted, and the order for an I-131 thyroid ablation was confirmed. (Name Removed), contacted the RSO to inform him of the events leading up to this misadministration.

The actions taken to prevent a future reoccurrence of a similar event include: -Training on the orders verification process in EPIC for all Nuclear Medicine staff members -Defining the difference between an EPIC Physician order and a non-EPIC Physician order -All non-EPIC Physician orders must have an attached copy of the original order or a call must be placed to the provider's office requesting a copy of the order if the patient does not have an original copy. Notified R1DO (Schmidt) and FSME (via email).

ENS 484887 November 2012 11:38:00The following was received from the State of Georgia via email: The Licensee reported to the Department (state of Georgia) on July 14, 2010 that a patient who received a prostate seed implant procedure on July 6, 2010 resulted in a medical incident. The patient was scheduled to receive a Cs-131 Isoray seed implantation for the prostate with a total planned activity of 194.3 mCi. During the procedure on July 6, 2010 it was noticed that many of the seeds implanted were not visible on ultrasound. Following final implantation of all the seeds, a cystoscopy was performed on the patient where it was revealed that 19 seeds were implanted in the bladder and not the prostate which was the intended implant site. All 19 seeds were removed from the bladder without difficulty. A post plan evaluation was completed the same day of the treatment. The total activity implanted (seeds implanted to the prostate) was determined to be 140 mCi with a difference of -54.3 mCi deviation from the total planned activity. Post plan D90 for the prostate was calculated to be 62.68% with a D90 deviation of 53.28 Gy from the dose prescribed of 85 Gy. An additional procedure was scheduled for the patient on July 12, 2010 where 18 seeds were implanted to bring the combined dose distribution to the prescribed amount. The department (Georgia Radioactive Materials) reported the incident to NMED in November 2012. Georgia Incident Summary: GA-2010-07i 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.
ENS 484701 November 2012 14:56:00

The following information was provided by the State of Georgia via email: Licensee informed the Department (Georgia Radioactive Materials Program) via written correspondence dated 8/28/09 that a patient who underwent a nuclear cardiology treadmill stress test on 8/17/09 resulted in an embryo/fetus exposure greater than 500 mRem. Prior to treatment the patient declared to the licensee that she was not pregnant and the licensee followed in house protocols in which all female patients under the age of 55 are asked if they are currently pregnant or breastfeeding. In the event that a patient is unsure the licensee postpones testing until a negative pregnancy test can be obtained. The patient later informed the licensee of her pregnancy on 8/27/09. Isotopes and activity administered to the patient were as follows: Tc-99m 26.9 mCi & Tl-201 5.38 mCi with a Total Activity of 32.28 mCi. RSO for the licensee & consulting medical physicists conducted a dose determination and the conclusion was that the embryo/fetus did receive an effective dose equivalent in excess of 500 mRem. The results were forwarded to the patient's OBGYN. This was a diagnostic misadministration that did not involve contamination.

  • * * UPDATE FROM TRAVIS CARTOSKI TO VINCE KLCO ON 1/30/13 AT 0943 EST * * *

The following information was excerpted from a received facsimile: (The update is concerned with) the radiopharmaceutical dose administration that a female patient recently received at testing facility. It was subsequently determined that this patient was 9 weeks pregnant. The patient received two dose administrations, one dose of Tc-99m - Myoview for the Stress Myocardial Perfusion scan and one dose of TI-201 as Thallous Chloride for the Rest Myocardial Perfusion scan. The patient received 26.9 mCi of Tc-99m-Myoview and 5.38 mCi of TI-201. The dose to the conceptus was approximately 2.53 Rad. Determination of dose is limited by patient habitus and physiology. Notified the R1DO(Bellamy) and FSME Resources via email. Report: GA-2009-18i NMED# 090812

ENS 484691 November 2012 14:56:00

The following information was provided by the State of Georgia via email: Licensee contacted the Department (Georgia Radioactive Materials Program) via telephone on 8/12/09 reporting that a patient who underwent a nuclear cardiology treadmill stress test on 8/3/09 resulted in an embryo/fetus exposure greater than 500 mRem. The Department received a report from the licensee on 8/14/12 describing that prior to treatment the patient declared to the licensee that she was not pregnant and the licensee followed in house protocols in which all female patients under the age of 55 are asked if they are currently pregnant or breastfeeding. In the event that a patient is unsure the licensee postpones testing until a negative pregnancy test can be obtained. The patient later informed the licensee of her pregnancy on 8/10/09. Isotopes and activity administered to the patient were as follows: Tc-99m 28.2 mCi & Tl-201 3.62 mCi with a Total Activity of 31.82 mCi. RSO for the licensee & consulting medical physicists conducted a dose determination and the conclusion was that the embryo/fetus did receive an effective dose equivalent in excess of 500 mRem. The results were forwarded to the patient's OBGYN. This was a diagnostic misadministration that did not involve contamination.

  • * * UPDATE FROM TRAVIS CARTOSKI TO VINCE KLCO ON 1/30/13 AT 0943 EST* * *

The following information was excerpted from a received facsimile: (The update is concerned with) the radiopharmaceutical dose administration that a female patient recently received at the testing facilities. It was subsequently determined that this patient was 4 months pregnant. The patient received two dose administrations, one dose of Tc-99m - Myoview for the Stress Myocardial Perfusion scan and one dose of Tl-201 as Thallous Chloride for the Rest Myocardial Perfusion scan. The patient received 28.2 mCi of Tc-99m-Myoview and 3.62 mCi of TI-201. The dose to the conceptus was approximately 1.97 Rad. Determination of dose is limited by patient habitus and physiology. Notified the R1DO (Bellamy) and FSME Resources. Report: GA-2009-12i NMED# 090811