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| Entered date | Event description | |
|---|---|---|
| ENS 56079 | 30 August 2022 14:10:00 | The following information was provided by the Oregon Health Authority, Radiation Protection Services via email: During preparation for a hepatic microsphere (ThereSphere) treatment, the oncology nurse primed the system but when the needle assembly was snapped into the dose vial a series of bubbles appeared. The nurse attempted to remove the bubbles from the tubing that was to be connected to the patient's catheter but was unsuccessful. The procedure physician was made aware of the bubbles and since the physician did not want to push them through the patient's catheter, the bubbled liquid was expelled into gauze which was subsequently added to the waste container. Working through this issue added approximately 10 minutes to the time between assay and administration. In addition, the assayed activity of Y-90 was 96.5 percent of the prescribed dose of 440 Gy and 95.6 percent at time of administration after the 10-minute delay due to the bubbled liquid issue. Normally, 95-99 percent of the assayed activity is delivered to the target (liver), however, with the loss of activity through expelling bubbled liquid, the delivered activity dropped to 351.8 Gy which is greater than the 20 percent lower limit of 440 Gy (352 Gy) at 20.4 percent and makes this a reportable medical event. (The physician notified the patient, documented this on the patient's chart, and stated there are no adverse effects from this under-dosing.) No additional dose is needed. Cause and corrective actions: It was stated the oncology nurse prepped the system 'correctly'. The licensee informed the TheraSphere representative regarding this issue with the needle assembly. At this time, we are unable to determine whether this event is considered human error or defective product. It is worthy to note that if one of the two issues (delay of 10 minutes or starting with 96.5 percent) was absent, the under-dosing of greater than 20 percent probably would not have occurred. Oregon Event Report Number: 22-0038 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 55812 | 31 March 2022 12:56:00 | The following information was provided by the Oregon Health Authority via email: On March 22, 2022, a High Dose Rate Delivery (HDR) sealed source of Iridium-192 was delivered by a common carrier to the wrong floor and clinic in a licensed (Salem Hospital) hospital. Instead of the shipping destination (given as Radiation Oncology/Attn: Dr xxx) on the 1st floor, the package was delivered to the 4th floor of the same building. The person receiving the package, who does not have radiation safety or transportation training, signed for it without an understanding of what it was and placed it on the floor of an access-controlled staff working area. On March 28, 2022, the licensee received an email request from the vendor (Varian) to schedule a date/time for installation of the new source. It was at this time that the licensee realized that the source had not arrived at their location and found the source had been delivered on March 22, 2022. An investigation was initiated and the source package was located in the 4th floor clinic. The package was surveyed and observed to be intact with no evidence of tampering . The transport index for the Type A Yellow -II package was noted at 0.9. The package was taken to the licensee's office and secured in locked storage. The licensee evaluated the dose received by clinic staff working in the proximity of the package. Clinic staff does not work a full shift in the area (five hours maximum/day) and the closest estimated distance from the package was measured at 2 feet (60 cm). The exposure period was 5 working days. The licensee performed dose measurements on and near the source package at various distances and orientations with a survey meter. The maximum dose received was while sitting in a chair and was calculated to be 0.4 mR/hr. Total dose received was given as: 0.4 mR/hr * 5 hrs/day * 5 days = 10 mR total exposure (~10 mrem or 0.01 rem equivalent dose). This dose-risk standard was based upon National Council on Radiation Protection and Measurements (NCRP) Report No. 91. Cause and corrective actions : The two subsequent causes are of the same nature, human error. First, the carrier failed to deliver the package to the labeled destination and person. Second, the hospital clinic signed for the package without checking the proper destination or person it was intended for. A potential third cause of human error is that the licensee failed to check on package delivery sooner if a tracking number was associated with this shipment. Corrective actions have not been instituted at this time since not all information has been collected for this event. The licensee indicated that they receive these shipments quarterly and wait for the vendor to schedule an installation. There was no indication given of tracking a replacement source package while it is in transit to the licensee's site. This is being investigated further. Information regarding the source activity, manufacturer, model, serial number and leak test date will be provided to the NRC Headquarters Operation Center when it is received from the Licensee. Oregon Report Identification Number: 22-0016 |
| ENS 56077 | 29 August 2022 11:05:00 | The following information was provided by Oregon Health Authority, Public Health Division, Radiation Protection Services via email: On December 17, 2021, while conducting a semi-annual inventory of radioactive material in possession, a Broad Scope A - Academic licensee found that a gas chromatograph (GC) containing one electron capture device (ECD) missing. The previous inventory was performed in May 2021 and most recent leak test performed in March 2021. (note: after March the lab was shut down during September 2021 for asbestos abatement and ECD marked as `in storage') Upon checking with the device custodian, the GC/ECD device was picked up in July 2021 by the campus surplus property group by request from the custodian for disposal. The device custodian verbally told the surplus property personnel taking the device that it contained radioactive material which they verbally acknowledged, stating they would contact Radiation Safety to remove it. However, this was not done. The licensee performed extensive searches of the lab where the device was housed, surplus property warehouse and campus metals scrap yard with negative results. It is possible the device/source was shipped to a local scrap metals dealer but after contacting the dealer this could not be confirmed. Cause and corrective actions: Primarily, the department in possession of the GC/ECD failed to notify the Radiation Safety Office of the intent to dispose of the device prior to contacting the Surplus Property Office as required by the licensee's Radiation Safety Manual. Secondarily, the Surplus Property Office personnel do not have the training to identify a device that potentially contains radioactive material and minimal, if any, radiation safety training. This resulted in loss of possession of a radioactive source with human error as the cause. Corrective actions include (1) an information bulletin was sent to departments that possess radioactive materials confirming radioactive material control procedures and responsibility for material unless explicitly cleared by Radiation Safety, (2) expanded safety instruction and meeting with surplus personnel to discuss GC/ECD's and other radiation hazards that may come to surplus, and (3) additional placarding of GC/ECD's, X-ray machines, (Liquid Scintillation Counters) LSC's, and sealed sources. Concerns: For many years, the licensee has relied on their rules contained in their Radiation Safety Manual regarding possession/security of radioactive material that are initially reviewed/acknowledged by the departments involved. The subsequent semi-annual inventories also include an acknowledgement of these rules by the department audited. Offering a device containing radioactive material for removal without first contacting the Radiation Safety Office is a violation of these rules. Surplus property personnel receive minimal, if any, radiation safety instruction and none regarding possession/security of radioactive material since the signage and sources are normally removed from the device(s) by the Radiation Safety Office prior to disposal. In addition, surplus property personnel were informed verbally of the radioactive material that was inside the device but failed to contact the Radiation Safety Office. These concerns have been adequately addressed by the licensee's corrective actions. Source: Nickel-63 Activity: 8.7 mCi (nominal 10 mCi on 4-5-01) Manufacturer: Shimadzu Model: VS2000 Serial number: C10893200343 Leak test date: March 24, 2021 Oregon Report Identification Number: 21-0061 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 49284 | 15 August 2013 15:46:00 | The following information was received by email: Oregon Radiation Protection Services was notified by email on 2/20/13 at 11:28 a.m. (PDT), by Curtis Kreil, RSO, a representative of Carestream Health, Inc., of one tritium exit sign discovered missing during a 6-month radioactive material inventory check on 2/6/13. The sign was last inventoried on 8/1/12. A site-wide email alert was issued regarding the missing sign. Exit sign details are: Manufacturer: SRB Technologies Model: Betalux E Serial Numbers: 258030 Radioactive material: H-3 Activity: Nominal 20 Ci (on 10/2/02), currently 11.2 Ci (2/20/13) Engineers and technicians are currently aware of the location of the (remaining) exit signs and monitor their presence. The licensee added discussion information into their Radiation Safety Training document regarding the exit signs and awareness of their location to assist in timely reporting of any future issues as a corrective action. Oregon Incident: OR-13-0011 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 49206 | 19 July 2013 19:00:00 | The following was received from the State of Oregon via email: Oregon Radiation Protection Services was notified by phone on January 19, 2011 at 1119 PDT, a representative of Good Samaritan Regional Medical Center, of a whole body (collar) badge report for the wear period of November 1-30, 2010 that exceeded the 5 rem dose limit. The monthly badge report was received by the licensee sometime after December 28, 2010 for an authorized user showing monthly/quarterly/annual dose as follows: Monthly (Nov 2010): DDE, LDE = 5230 mrem SDE = 5032 mrem Quarterly (4Q2010): DDE, LDE = 5290 mrem SDE = 5091 mrem Annual (2010) and Lifetime (hired in 2010): DDE, LDE = 5376 mrem SDE = 5175 mrem The vendor (Landauer) performed a second read of the dosimeter that agreed with the reported doses above and stated that the imaging indicated an 'irregular exposure.' The authorized user stored his badge and ring in a 'cubby' along with his lab jacket. "On January 24th, the licensee emailed Oregon RPS with results from the licensee's investigation stating that the badge user was a student on rotation to the nuclear medicine dept. for the month of November. The user's previous WB badge results were 'normal' and no other nuclear medicine worker received a high dose reading during November. The student was '100% supervised' and is described as 'very conscientious about spills or drops.' Regardless, the licensee determined after eliminating several factors, that contamination was the most probably factor since the collar badge result was higher than the user's finger ring (4480 mrem SDE November, 5220 mrem SDE for 2010) and 'irregular exposure' noted by the dosimetry vendor. It remains unknown what isotope caused the overexposure and any Tc-99m has decayed to background. Surveys of the cubby and lab jacket were performed with negative results. In addition, the licensee stated that no 'large' iodine doses were administered for November. Remedial actions were not noted on the report. On July 16, 2013, a review was performed of this incident and it was discovered that it was not reported to the US NRC HOO as per the NRC's Reporting Material Events (SA-300), Appendix A. The specific requirement is 10 CFR 20.2203(a) which states, in part, that radiation doses that exceed the regulatory requirements (5 rem) are to be reported (30 day requirement). The licensee was e-mailed for any remedial actions taken after this event. On July 19, the licensee responded by e-mail stating that without a definitive cause for the overexposure, no change in procedure was instituted except heightened awareness of badge placement/location. The report was written and submitted via e-mail to the HOO on this same date. Oregon Radiation Protection Services noted on the Incident report that US NRC Operations Center was to be notified but this was not done." State Event Number: OR-11-0004 |