Semantic search
| Entered date | Event description | |
|---|---|---|
| ENS 49251 | 8 August 2013 16:06:00 | The following information was obtained from the State of New York via facsimile: On 08/07/2013, the licensee called to report an overexposure of an individual as measured with an extremity monitoring device (ring badge). The licensee had been notified by the processor on the morning of 08/07/13 in regard to the 242 rem shallow extremity dose. The monitoring period for the ring badge is one week, and the whole body monitors are exchanged on a monthly basis. The affected individual is a male production technologist whose duties include cyclotron operations. The RSO and consulting health physicist are investigating and NYS DOH (New York State Department of Health) will perform an onsite review. The licensee has reassigned the technologist to non-radiological duties, sent the individual's whole body badge via overnight service for an emergency read and has requested the badge vendor to perform any additional analysis of the ring badge that may provide additional information. This event summary will be updated after the results of the licensee's and DOH's investigations are available. New York Event Number: NY-13-04 |
| ENS 46009 | 15 June 2010 10:44:00 | The following information was received by facsimile: A misadministration involving the implantation of radioactive seeds into the prostate (permanent brachytherapy) was reported to (the New York State Department of Health) office on May 28, 2010. The patient, a 58 year old male diagnosed with prostate cancer, Gleason score of 6, PSA of 3.8, was implanted on May 26, 2010. The prescribed dose was 145 Gy, to be delivered using Iodine-125 seeds, with an activity of approximately 0.36 mCi/seed. The patient was implanted with 112 seeds. A significant number of seeds (22) were placed outside the prostate gland, inferior to the gland (5.4 cm) and in the perineum. According to the medical physicist's calculations, the implanted area of the prostate received a D90 of 140 Gy. The initial indication is that the misplacement is a result of misidentification of the prostate by the radiation oncologist who performed the procedure. Ultrasound and C-arm fluoroscopy systems were used to aid with positioning the seeds. It appears that the patient's colon was not properly prepared, which caused poor ultrasound imaging. In addition, a Foley catheter was not inserted into the bladder, which made bladder localization difficult. A post implant confirmatory fluoroscopic image was obtained and the radiation oncologist observed that the sources were outside of the prostate area. On May 28, 2010, a post implant CT scan was performed which confirmed the seed locations and allowed for a calculation of the DVH (Dose-Volume Histogram) to the perineum of 10.0 Gy. The medical record has been requested and will be sent out for an expert review. New York Event Report ID No: NYDOH-10-01 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 45480 | 6 November 2009 15:03:00 | New York does not publish the name, address or license number of its licensees in incident reporting to the NRC. The following information was received via e-mail: Event description: Best Theratronics was performing a security upgrade (hardening) on an AECL Gamma Cell 40 irradiator, containing AECL Model Number C-161 cesium-137 sources, and discovered radioactive contamination indicating a 'leaking' source. Coincidently, (Department of Health representatives) arrived at the licensee's facility for a planned site visit at noon on 11/03/09, and were able to assess the situation with the vendor and Radiation Safety Officer (RSO). The engineers noticed that one of the pneumatic source drive mechanisms moved noticeably slower than the other. They removed the pneumatic drive assemblies and manually moved the source drive rods. They noted excessive resistance to movement and noticed corrosion (rust) on the source rod. They wiped the rusty material and measured the wipe with a thin-window GM detector, which indicated radioactive contamination. Further sample analysis confirmed removable cesium 137 (isotopic analysis) in excess of the leak test limit. The contamination is limited to the areas of the source drive components only. Radiological surveys were performed on personnel, tools, the room, etc. with negative findings. In consultation with the service engineers, the RSO, and (Department of Health representatives), the decision was made to abandon the hardening procedure. The unit was reassembled and taken out of service. DOH will work with the licensee to determine what options, if any, exist for disposal of the unit. DOH will also follow-up with Best Theratronics in regard to their procedures for PM (i.e., is leak testing performed in areas such as the drive mechanism during routine PM service or during hardening). Also, we will inquire about actions such as a notice to owners and/or assessment of other licensee's units, etc. Contamination on both source rods may indicate a generic source integrity issue. |
| ENS 43443 | 25 June 2007 16:45:00 | The following notification was received from the State of NY Bureau of Environmental Radiation Protection via fax: AS Agency -New York State Department of Health Event Report - ID # NYS DOH 07-002 Licensee Name and License Number - Withheld as per NYS Law Event Date - June 19, 2007 Event Type - Medical Event Event Description: A medical event involving yttriurn-90 Zevalin (Ibritumomab Tiuxetan) for treatment of non-Hodgkin's lymphoma was reported to NYS DOH by telephone on June 22, 2007. The authorized physician user (AU) approved a dosage of 29 mCi for treatment on June 19, 2007, however a dose of 36.7 mCi was administered. This Zevalin patient (A) was scheduled to receive treatment at the hospital on June 19, 2007. The radiopharmacy prepared the dose but observed that the assay from the supplier was approximately 10 mCi higher than their assay. They reviewed their data including their most recent calibration of the dose calibrator with a NIST traceable syringe standard. They decided to use their NIST traceable calibration factor and associated assay. The dose was dispensed and the patient was treated. Another Zevalin patient (B) was scheduled for treatment on June 20, 2007. In preparing patient B's dose the radiopharmacy observed the same condition as with patient A's assay. At this point they realized they had a problem and patient B's dose was not dispensed. An investigation began. The radiopharmacy identified the error. They used an AEA Technology QSA Inc. model SIM.SY2 (Sealed Source Registry No. MA-1059-S-360-S) to calibrate their Capintec CRC-15R dose calibrator as well as the hospital's dose calibrator. This source is specifically designed to calibrate Capintec CRC-15R units for yttrium 90 assays. The calibration source label has an assay of 20mCi (740 MBq) of strontium 90/ytrrium 90 and a calibration date of Nov. 14, 2004. However, the source certificate lists the yttrium 90 'Equivalent Activity' as 30.68 mCi (1135 MBq), which is the value that should have been used for the calibration. Apparently the certificate was not available (misplaced?) on June 8 &10 for the calibration. The radiopharmacy used the decay-corrected value from the label rather than a decay-corrected value of the certificate's 'Equivalent Activity'. Since the same calibration error was performed on the hospital's dose calibrator, the hospital's assay matched up with that of the radiopharmacy and with the intended dosage. The patient's daughter and the referring physician were notified on the day after discovery. The treating physician is assessing situation and the possible effects to the patient. Intended dose - 29 mCi Delivered dose - 37.6 mCi Date of treatment - 6/20/07 Date of error discovered - 6/20/07 Isotope/drug - yttrium-90/Zevalin Reported/notification dates: "Patient/patient rep. - 6/20/07
"Referring MD - 6/20/07
"NYS DOH - 6/22/07
Cause: Dose calibrator calibration error Effect - patient's condition and effects are being assessed Investigation - RCA required Initial Written report due 6/29/07
This event (EN43443) has been reviewed and determined to be a reportable medical 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. |
| ENS 43301 | 13 April 2007 15:56:00 | The State provided the following information via facsimile: A brachytherapy misadministration involving a 31year old female patient with a history of vaginal cancer was reported to NYS DOH BERP on 3/9/07. The patient was successfully treated to 5590 cGy to the target volume using external beam (IMRT) therapy and she was to receive 2500-3000 cGy via interstitial brachytherapy with both Cesium-137 and lridium-192 (seeds in ribbons) sources. The medical physicist developed a treatment plan as directed by the authorized user/ radiation oncologist using a commercial treatment planning software application. Eleven ribbons with 8 seeds each and an activity of 1.855 mgRaEq per Ir-192 (3.19 mCi) seed were ordered from Best Industries. Hospital owned Cs-137 sources were selected for use. The medical physicist verified source strength of all sources. The oncologist reviewed and approved the plan. He prescribed a total dose of 2500 cGy to be delivered to the 50 cGy-isodose line for a total treatment time of 50 hours. At 2:30 PM on 3/6/07 the sources were placed into the patient. A Syed template was used to place the ribbons and the Cs-137 sources were loaded into a tandem applicator. On 3/7/07, late in the morning, the medical physicist performed a manual check of the treatment plan calculations and identified a significant discrepancy - the hand calculations indicated a significantly higher dose rate than what was generated from the treatment planning software. An investigation ensued, which included consultation with the TPS vendor's application specialist. After several hours of investigation it was determined that the original treatment plan was in error, and at 5:30 PM on 3/7/07, after 27 of the intended 50 hour treatment time, the radiation oncologist decided to remove the sources (from the patient). Instead of the intended 2500cGy, the patient received an estimated dose of 4590 cGy and the anterior rectal dose was approximately 7300 cGy. The licensee provided a written report as required, and DOH staff performed an on-site investigation on 3/21/2007. Cause and contributing factors: 1. The primary error was the use of an inappropriate Dose Rate Factor in the TPS. The value used corresponded to the DRF for Air Kerma however the source strength entered was in MgRaEq. The physicist should have changed the units of source strength or entered the correct DRF. 2. Changing the units of activity in the TPS does not generate a prompt for a new Dose Rate Constant. 3. During the physics review it was determined that acceptance testing of this treatment planning software did not include Iridium-192. The acceptance testing covered Cesium -137 and Iodine -125 seeds which where the only materials being used at the time. If this testing had been performed the physicist would have been more likely to recognize that the treatment planning system does not automatically select the correct dose rate factor when the source strength units are changed. 4. There was no check of the preplan before the seeds arrived although there was sufficient time (sources ordered 2/27/07). The plan was approved on 3/6/07. 5. Neither the physicist nor the radiation oncologist had prepared a treatment with Ir-192 in six years and the physicist had not used this particular TPS for Ir-192 implants. It would have been prudent to have an additional review or outside review in order to verify there were no oversights or errors. 6. The double check was not done until after the day after sources had been implanted. Again while the physicist was observing the minimum requirements of Part 16 it would have been prudent to perform a check of the calculations either prior to the implant or immediately thereafter. Corrective action: The policy and procedures have been changed to require a check of calculations for any single fraction brachytherapy treatment to be performed and approved prior to initiation of treatment. Patient condition and follow-up: The radiation oncologist disclosed that the patient is at risk for radiation cystitis, rectal proctitis and more importantly, fistula formation between the rectum and the vagina. The patient will be monitored closely over the next year by both her gynecologic oncologist and the radiation oncologist. The patient is currently being treated with broad spectrum antibiotics along with daily treatments in a hyperbaric oxygen chamber. NY Event No: NYS-DOH 07-001
This event has been reviewed and determined to be a reportable medical 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. |
| ENS 40943 | 12 August 2004 17:12:00 | A New York State Department of Health licensee reported on 8/10/04 that prostate seed implant needles were found to be contaminated during a post implant radiological survey in the operating room. Two post implant urine samples from the patient were saved and were found to be contaminated as well. Radiograph of the prostate post implant indicated all seeds were implanted. Hospital staff believed that the contamination was attributable to the implant procedure as the patient had not received a diagnostic nuclear medicine procedure and there was no evidence of any other source for the contamination. The radiation oncologist contacted the patient and was able to administer KI (Potassium Iodide) later in the day, and he will evaluate the need for ongoing treatment with KI. New York State Department of Health staff went to the hospital on 8/11/04 to investigate this incident. Confirmatory measurements were made and the plastic needle packing tray, needles, lead pouch and urine samples were found to be contaminated. A third urine sample was obtained from the patient on 8/11/04, which also is contaminated. The radiation oncologist who performed the procedure stated that there were no problems with the needles or the implant procedure. The needles were examined and no bends, crimps or damage were observed. The hospital, has notified the pharmacy that had provided the preloaded sterile needles. NRC Region 1 staff were contacted by phone and were given the name of the pharmacy. The Radiation Safety Officer took the initial urine sample to another New York State Department of Health licensee on 8/11/04 for nuclide identification and rough quantification using a HPGe detector. The isotope in the urine was identified as I-125 and the activity was estimated to be 34 nanocuries per cc (volume of urine sample collected was 200 cc). The patient's urine samples will be sent to DOH Wadsworth Laboratories for analysis. Future samples are expected to be collected and analyzed. The brachytherapy seeds were manufactured by Mills Biopharmarmaceuticals, Inc., sold by Mentor MBI (Oklahoma City, OK) and loaded into needles by the pharmacy. Brachytherapy seed specifics are: Model: 125SL Lot Number: 042814 Batch Number: IB040142N Seed activity on 8/10/04: 0.405 millicuries |