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| Entered date | Event description | |
|---|---|---|
| ENS 50584 | 30 October 2014 18:17:00 | This is a notification of a medical event that occurred on October 30, 2014 at 1000 EDT in which the Y-90 SIR-Sphere dose delivered to the patient's posterior portion of the right lobe of the liver was more than the prescribed dose by 20 percent or more (10 CFR 35.3045). This patient had a dual administration, with the correct dose administered in accordance with the written directive to the anterior portion of the right lobe of the liver (0.43 GBq and 53.4 Gy). The medical event occurred before this, when the patient who was prescribed a dose of 0.39 GBq (64.5 Gy) was administered a dose that was 20.5% more than the prescribed dose. The posterior portion of the right lobe of the liver was administered 0.47 GBq (77.5 Gy), which was the intended dose for the anterior portion of the right lobe of the liver. The total dose to the right lobe of the liver (both posterior and anterior portions) was 0.90 GBq (142 Gy) compared to the planned dose of 0.91 GBq (143.6 Gy). Our color coding procedure failed to prevent this error. The radiopharmacy staff had applied the green colored dot to the QMP (Quality Management Program) and Dose Planning Forms appropriate for the posterior portion of the right lobe. The medical physicist applied the green colored dot to the checklist intended for the anterior portion of the right lobe rather than to the checklist intended for the posterior portion of the right lobe. The error was not caught during the time out prior to the dose administration. Upon completion of the first of the dual administrations, the medical physicist identified and reported the error to the authorized user and RSO. A time out was called and the decision was made to prepare a new Y-90 SIR-Sphere dosage for the anterior portion of the right lobe in accordance with the written directive. The correct dose was then administered in accordance with the written directive to the anterior portion of the right lobe of the liver (0.43 GBq and 53.4 Gy). To prevent this from occurring, the color coding procedure was revised by the Radiopharmacy and modeled after their blood labeling process. The check list was revised to instruct the medical physicist that 'If dual administration case, verify correct color dots on QMP form, dose plan, and checklist.' Before a dual administration case is started, the dose planning page with the correct corresponding color dot will be pulled from the paperwork and placed in the control room. This allows the AU (authorized user), physicist, and remaining team (techs, nurses) to see the plan clearly. Once the physician (AU) gains access to the first treatment site, they will give the verbal notice to the physicist, so they can assemble the corresponding dose. With the finished assembly in place table side, the AU and physicist will verify the dose intended for the location. As it pertains to this case, the physician would say, 'We are in the posterior right lobe, the dosage is 0.52 GBq and is labeled with the orange dot, correct?' The QMP was revised to include these revised procedures. No adverse effect is expected for the patient. Both the patient and the referring physician were notified on October 30, 2014. 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 48975 | 26 April 2013 13:45:00 | During an audit of a satellite facility associated with Beaumont Health Systems, the Radiation Safety Officer (RSO) determined that a package of radioactive material with removable surface contamination on the outside of the package greater than NRC reporting limits had been received but not reported to the NRC as required per 10 CFR 20.1906(d)(1). The package was received on February 21, 2013 and wipe tests performed on the external surface of the package. Removable contamination levels were found on the package of 19,070 dpm/300 cm2. This level exceeds the reportable limits specified in 10 CFR 71.87(i). The package contained Technetium-99m that had been shipped and delivered by Beaumont's Troy Hospital facility. The receiving facility did not find any damage or contamination on the Tech-99m vial or inside the ammo case used to transport the vial. The audited receipt inspection report revealed the external package contamination event was documented but not reported to the company's RSO. Troy Hospital was notified at the time of the event and contamination surveys were performed at the packaging location, on the transport vehicle, and on the driver. The only contamination found was a wipe used to wipe the area where the package had been stored in the truck (wipe-down of radioactive material lay-down area is routine protocol for the licensee). The RSO stated that corrective actions are being taken related to improving contamination controls while packaging these shipments. In addition, improvements in the process related to reporting events to the RSO and the NRC are being explored.
The removable contamination of 19070 dpm/300cm2 equates to 63 dpm/cm2 which is below the reportable limit of 220 dpm/cm2. Therefore, this event is retracted. Notified the R3DO (Duncan) and FSME Resources (via e-mail). |
| ENS 44537 | 3 October 2008 14:45:00 | One I-125 sealed source ('seed') intended for permanent prostate implantation on 9/8/08 cannot be located definitively inside the patient or inside the hospital and is assumed lost. The calibrated activity was 0.481 mCi on 8/25/08. On the morning of 9/8/08, a permanent prostate implant was performed in our high dose rate (HDR) treatment room in Radiation Oncology under sterile conditions. The implant was to consist of 62 seeds, in twenty needles each containing a varying number of seeds of 0.408 milliCurie of I-125. Seventy I-125 seeds were ordered and pre-loaded in a cartridge and were received sterilized from Isotron. Prior to treatment, one of the seeds was expelled from the cartridge and used for calibration. It was stored in a separate shielded container, and not used in the patient treatment. The written directive and treatment plan intended implantation of 62 I-125 seeds into a patient's prostate for the treatment of cancer. Using the Nucletron seedSelectron remote afterloading system, each needle was placed under ultrasonic guidance in the patient's prostate. The seedSelectron was connected to each needle and the seeds ejected from the cartridge into the needle. This procedure was performed for each of the twenty needles with only one needle being implanted at a time injecting a total of 62 seeds. The treatment progressed normally as planned and was successfully completed. At the conclusion of the treatment, X-rays were taken to verify the number of seeds implanted, and the count of 61 instead of 62 was confirmed radiographically. Prior to exiting the room, all staff (radiation oncologist, nurse, physicist, brachytherapy specialist) completed the routine required survey which included the soles of the shoes. The residual seeds in the cartridge were x-rayed and seven I-125 seeds were identified by at least 3 medical physicists. At least 3 medical physicists and the authorized user examined the patient's x-rays, and each could clearly identify only 61 seeds in the patient. The one I-125 seed used for calibration was accounted for in the inventory. The patient was scheduled to return for bi-plane views on 9/10/08, so that additional radiographs could potentially identify the missing seed. When the patient returned on 9/10/08, he had excreted four I-125 seeds which were properly handled and placed in the secure designated storage area. On the follow up x-rays, only 57 seeds were clearly identified. The anatomy surrounding the prostate was also imaged, but only 57 seeds were clearly identified. The entire pelvic region, abdomen and chest were also imaged with no results. It is possible that the seed may have migrated to an area inside the patient which was not included on the follow up x-rays. The pre-loaded cartridge of seeds was not x-rayed prior to the treatment, so the presence of all 70 seeds was not confirmed prior to the treatment. It is conceivable that only 69 seeds were shipped. We contacted Isotron and they provided us with their documentation showing that they shipped 70 seeds. The most probable disposition is that the seed is located inside the patient, but has migrated to an area which does not allow us to confirm its presence radiographically. The second most likely explanation is that we only received 69 seeds instead of 70 seeds. It is unlikely that the seed is lost inside our HDR suite, given the normal progression of the implantation procedure and the thoroughness of our search. It is very unlikely that the seed was disposed of in the landfill or sewer, since it was not detected when the team of medical physicists individually surveyed each item of linen and trash, and thoroughly surveyed the sink. No exposure of individuals to radiation from the one missing I-125 in restricted and unrestricted areas is expected. A thorough search was initiated immediately, using a pancake thin end window Geiger-Mueller detector in the micro-R/hr range (Ludlum Model 14C, calibrated on June 4, 2008). The surgical table, floor, each item of trash, each item of linen and all personnel were carefully surveyed. All cartridges and needles were rechecked several times. A thorough survey of the surgical table was conducted, urine collection bag and patient (even near the pelvis, although exposure from the implant made detection in this vicinity unlikely). The low survey readings in adjacent areas of the patient made it unlikely that the seeds were on the patient. The patient was released and removed from the HDR room and transferred to Phase I recovery. The survey also included the entire entrance hallway to the HDR room and the radiation oncologist's office. The Radiation Safety Officer designate for Radiation Oncology was notified and an additional survey of the room was conducted with the Johnson survey instrument (GSM-15) with a plastic scintillator (GLE-1), calibrated with an I-125 source on January 4, 2008. The surface of the floor including the small cracks in the floor covering and at the baseboards was surveyed. Each item of trash and linen was checked separately. The Corporate Radiation Safety Officer was notified and conducted an independent search with the Johnson survey instrument which included the entire floor, baseboards, sink, each item of equipment in the HDR room, the linen and trash. When nothing was found, the room was released so that patient treatments could be resumed in the room. A repeat survey of the patient using a Geiger-Mueller detector in the microR/hr range (Victoreen model 190 with pancake probe, calibrated April 24, 2008) as well as the areas surrounding the patient, trash and linens was performed in the Phase I area. All readings were low indicating the source was not in the vicinity. The patient was then discharged to Phase II. A survey including the patient, stretcher, linens, trash, urinary catheter, urinary bag and area was performed in Phase II. Low readings were again observed indicating the source was not in the area. The unused seeds were returned to the locked cabinet in the other HDR room for inventory and storage. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss of licensed material: (1) All personnel involved with prostate implants will receive refresher training regarding proper procedure. (2) An image of the loaded cassette will be taken to verify the receipt of the correct number of seeds. This image will be retained along with the patient records. In the event the seed count on the image does not agree with the count per the manufacturer, the situation will be reconciled prior to treatment. (3) Every effort will be made to obtain a seed count that accounts for all of the seeds received from the manufacturer prior to the discharge of the patient. The licensee has reported this event to NRC Region III. 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. Although IAEA categorization of this event is typically based on device type, the staff has been made aware of the actual activity of the source, and after calculation determines that it is a Less than Cat 3 event. Note: the value assigned by device type "Category 2" is different than the calculated value "Less than Cat 3 |
| ENS 42975 | 8 November 2006 17:39:00 | The Radiation Safety Office for the licensee reported an event where a patient received less than the prescribed dose during a treatment for liver cancer using Yttrium - 90 microspheres. Specifically, the patient was prescribed 9.8 millicuries to the liver using Yttrium - 90 SirTex Sirspheres using a intrahepatic catheter. The patient only received 6.5 millicuries due to problems in the administration of the dose. After administering about half of the treatment dose, the physician started to encounter injection resistance which is not uncommon with this treatment due to vasculature loading. The physician stopped the treatment and was trying to view the microsphere placement in the liver using fluoroscopy when he noted some unusual "clumping" of the microspheres between the delivery vial and a 3-way stop cock that connects to the catheter. Because of the clumping and the resistance, the physician elected to discontinue the administration of the remainder of the dose. The licensee has contacted SirTex and plans to send the delivery device with the clumped microspheres to SirTex when the Yttrium - 90 has decayed away (in a couple weeks) for further evaluation of the product. The licensee has also contacted the Region 3 NRC inspector (Piskura) about this event. 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.
The RSO called to indicate this event was reviewed by Region 3 and was determined to not meet the criteria for a reportable event, therefore the event is being retracted. Notified R3DO (Kozak) & NMSS (Janet Schlueter). |
| ENS 40797 | 8 June 2004 17:03:00 | On Tuesday, June 8, 2004 at 2:25 p.m., a patient was scheduled for an I-131 thyroid uptake with an oral dose between 5 and 20 microcurie. Instead, the patient was administered 915 microcurie (34 MBq), which resulted in an absorbed dose of 2675 rad to the thyroid (assuming a 55% radioactive iodine uptake) and 81 rad effective dose equivalent. Each Month the Radiopharmacy prepares an oral solution of sodium iodide I-131 for uptake doses which are pipetted into individual patient dose vials. The sodium iodide I-131 uptake solution for June contained 12 microcurie per milliliter (ml) in a total volume of 300 ml. The Radiopharmacy technologist prepared the uptake dose by pipetting one ml of solution into the patient vial, which, should have yielded a dose of approximately 12 microcurie. The pipette that the Radiopharmacy technologist used to prepare this dose had been used earlier in the day to prepare therapeutic doses of I-131, and was labeled as the therapy pipette. The Radiopharmacy technologist did not realize that she had picked up the pipette labeled for therapy and assumed it was the pipette used for preparing the uptake doses. Usually the uptake pipette is stored in a shielded vial in the far right corner of the fume hood, but in this case, the therapy pipette was located in the far right corner. The Radiopharmacy technologist assayed the dose in the dose calibrator and noted that the reading was too high for an uptake dose. This caused the staff to question which pipette was used, and they confirmed that the therapy pipette was used. The Radiopharmacy staff discarded the dose in accordance with radioactive waste procedures, and proceeded to draw another uptake dose with the pipette labeled for uptakes. One milliliter was drawn and assayed in the dose calibrator and read 0.915 mCi/ml. The Radiopharmacy technologist accepted the dose thinking that it was really 9.15 microcurie instead of 0.915 millicurie. The computer program is set up to accept I-131 uptake doses on the basis of correct volume and since the volume was within the acceptable range of 1 ml, the computer printed a label for the dose and it was dispensed. The nuclear medicine technologist followed the procedure for confirming the dose prior to administration by checking the patient name, ID number, the I-131 uptake procedure and circling the dose. She looked at the dose printed on the label and thought that the dose was 9.15 uCi instead of the what was printed on the label (0.915 mCi), and administered the dose to the patient. The Radiopharmacy technologist became concerned about using the wrong pipette and contacted the Radiopharmacist, who then discovered the error. The therapy pipette contained residual millicurie amounts of therapeutic I-131 solution which contaminated the I-131 uptake dose. B. Why the Event Occurred The root cause was determined to be the lack of an adequate double check of the I-131 uptake dose prior to administration. A pipette contaminated with 2 millicurie I-131 was inadvertently used to prepare the uptake dose. The Radiopharmacy computer was programmed to detect volume errors, but not activity errors, so it accepted the dose and printed the label. The Radiopharmacy technologist did not detect the error when she assayed the dose for this second redraw, because she assumed that the activity displayed 9.15 uCi, rather than the actual activity displayed, which was 0.915 mCi. The nuclear medicine technologist who double checked the dose mistook the 0.9 mCi for 9 uCi on the dose label and administered the dose. She had been working in an imaging room, but was needed to cover the thyroid uptake room near the end of the work shift. This may have contributed to the error made when confirming the dose. C. The Effect on the Patient The absorbed dose to the thyroid was 2675 rad (assuming a 55% radioactive iodine uptake) and the effective dose equivalent was 81 rad. The patient is expected to return to William Beaumont Hospital tomorrow (6/9/04) for treatment with I-131 for hyperthyroidism. The additional dose given for the uptake is a fraction of the dose that will be administered for therapy. The patient is not expected to have any adverse effects. D. What improvements are Needed to Prevent Recurrence A complete investigation was conducted to determine the root cause of the medical event. A new pipette will be used for each I-131 uptake patient dose, which will prevent the cross contamination. The computer will be re-programmed to accept uptake dose activity (ie., 5 - 20 microcurie) rather than volume. The computer will not print a label for the uptake dose unless the activity is within the predefined range. The radiopharmacy staff have been trained not to over-ride the failsafe mechanisms of the computer. The nuclear medicine technologist will be retrained in the dose verification process prior to a dose administration. Both the Radiopharmacy technologist and the nuclear medicine technologist will review the dose units (i.e., microcurie, millicurie, MBq) and pass a test. E. Actions Taken to Prevent Recurrence 1. A new pipette will be used for each I-131 uptake patient dose, which will prevent the cross contamination. 2. The computer will be re-programmed to accept uptake dose activity (i.e., 5 - 20 microcurie) rather than volume. The computer will not print a label for the uptake dose unless the activity is within the predefined range. 3. The nuclear medicine technologist will be retrained in the dose verification process prior to a dose administration. 4. Both the Radiopharmacy technologist and the nuclear medicine technologist will review the dose units (i.e., microcurie, millicurie, MBq) and pass a test. |