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| Entered date | Event description | |
|---|---|---|
| ENS 50644 | 28 November 2014 10:57:00 | The following email was received from the State of Ohio: On Wednesday, November 26, 2014 at 1129 (EST), the Interventional Radiologist Authorized User (AU) physician began to administer the prescribed activity of 1.38 GBq Y-90 micro-spheres (Theraspherer) for an estimated dose of 125 Gy to segment 7 of the right liver lobe. After a couple of 20 cc syringes of saline had been pushed through the administration kit, the Nuclear Medicine technologist made an ion chamber measurement of the dose vial and tubing set and observed a very high reading of 2.5 Roentgens/hour using a Keithley 451B/RYR, serial number 2935, ion chamber with the beta window open. This was a very high measurement, so the AU physician continued to push an additional 6 syringes of saline for a total of 8 syringes through the administration set with very little reduction in the ion chamber reading. At that point the AU physician decided to call an end to the therapy. The administration set was moved out of the room and using the manufacturer's template, the Nalgene jar containing the dose vial and tubing set in the plastic beta shield was measured as 0.55 mR/hr versus a pre-therapy measurement of 2.3 mR/hr. This meant that approximately 24 percent of the dose remained in the dose vial and/or tubing set and micro-catheter. The RSO then asked the Nuclear Medicine technologist to take the Nalgene jar to the hot lab to measure the dose vial, tubing set and micro-catheter individually in the dose calibrator. Each of the items were carefully wrapped and measured in the dose calibrator using a calibration factor of 048 for the dose vial and 086 for the tubing sets. The Capintec CRC 15-R, serial number 156151, dose calibrator measurements were 0.009 GBq in the dose vial, 0.31 GBq in the 'D' line tubing set and 0.038 in the micro-catheter for a total of 0.357 GBq of the 1.44 GBq decayed to the time of administration which equals about 24.8 percent of the total dose. The prescribed dose was 1.38 GBq which would deliver about 125 Gy to the segment 7 of the right liver lobe; subtracting the 0.357 GBq the calculated dose to the liver segment was 98.15 Gy or about 78 percent of the prescribed dose. The Radiation Safety Officer contacted BTG International (Canada) to file an incident report and provided all of the specific details of the incident (Incident Report Number: OTT-PC-14-0073). The BTG representative asked to check with the AU physician to see if he administered the saline at approximately 20 cc/min, and not less than 10 cc/min so that the micro-spheres would not settle out of suspension during the administration. The tubing set and dose vial will be stored for decay-in-storage and returned to the manufacturer for further analysis. After interviewing the Authorized User physician following the case, he said that there was no medical reason related to the patient that lead to the under dose, and that he intended to administer the entire 125 Gy to the liver segment throughout the therapy. He also mentioned that the delivered 98.15 Gy to a small segment of the liver (segment 7) was therapeutic and provided optimal treatment dose to the tumor. He explained that the delivered dose that differed by more than 20 percent from the prescribed dose had no consequences to the patient and there is no requirement to repeat the treatment. He also mentioned that he pushed the saline with at least a rate of 10 cc/min or higher not exceeding 20 cc/min. According to the Ohio Administrative Code, 3701:1-58-101, Report and Notification of a Medical Event, the total dose exceeded 0.5 Sv (50 rem) to an organ and differed from the prescribed dose by more than 20 percent, and therefore, met the reporting criteria. A telephonic report was made by the Radiation Safety Officer to the Ohio Department of Health at 1615 (EST) on 11/26/2014 regarding this incident. The Authorized User physician that administered the therapy was the referring physician and notified the patient the day of the procedure. The Nuclear Medicine imaging following the therapy indicated that the microspheres were administered to the correct liver region. 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 48235 | 27 August 2012 14:04:00 | The following information was supplied by the State of Ohio Department of Health via e-mail: RE: Leaking I-125 prostate sealed source Date: August 24, 2012 Source Type: I-125 Prostate Seed, Model STM1251, distributed by Bard Activity: 0.334 mCi/seed on 8/24/12 During a prostate seed implant a seed became jammed in the Mick gun. The gun was placed on sterilization table and examined. It was found that the seed was lodged in the Mick cartridge. The cartridge that held the seed was removed from the gun over a basin full of water and the end result was the seed broke into two pieces. One piece was recovered in the water and the second was still lodged in the end of the Mick cartridge. The area was surveyed for any additional contamination and none was found. All personnel involved in the case were surveyed and no additional contamination was found. The broken I-125 seed was wiped and analyzed with the equipment below: Well Chamber- Captus 3000 s/n CNV-376 (located in Nuclear Medicine) Background- 339 cpm Wipe- 17.63 Mcpm = 21.24 Mdpm = 9.6 �Ci The wipe test revealed that the removable contamination exceeds the 0.005 �Ci. Bard, the company that supplied the seeds was contacted. The leaking I-125 seed and contaminated water was sealed and placed in the radiation waste storage area. |
| ENS 47071 | 19 July 2011 10:05:00 | Approximately four (4) weeks prior to the therapy, patient was scanned for extrahepatic shunting through injection of 99mTc MAA into the hepatic artery per protocol. No shunting to the duodenum was identified. On Tuesday July 12, 2011, at 11:00 AM the patient was treated with 0.977 GBq of 90Y TheraSphere per protocol. Interventional Radiologist properly placed catheter. A second interventional Radiologist confirmed the catheter placement. On Tuesday July 12, 2011 at 6 PM, post procedure scan identified significant activity in the duodenum. Initial estimate indicates 0.117 GBq had shunted into the duodenum approximately 12% of the administered activity. An initial estimate indicates dose to duodenum is approximately 110 Gy. The asymptomatic patient was discharged with follow up contacts for possible intervention as a result of the dose to the duodenum. Patient has been notified. Referring physician has been notified. Literature search indicates patient may have developed vascularization post-scan, pretreatment. An inspector from the Department (Ohio Bureau of Radiation Protection) will conduct an inspection the week of July 25, 2011." Ohio Event Report Number: 2011-014 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.
Based on further review by the licensee, the patient's organ in question did not receive the above referenced dose. Notified the R3DO(Duncan) and FSME (Zelac). |
| ENS 45061 | 13 May 2009 09:58:00 | Ohio Department of Health (ODH) Bureau of Radiation Protection (BRP) was notified of a medical event that occurred at The Urology Center, LLC located at 4700 Smith Road, Suite M, Cincinnati, OH. 45212, Ohio license # 02200310002 at 12:30 PM 05/12/2009. The patient received a permanent implant of 64 I-125 seeds on 5-11-09. The total activity implanted was 28.422 mCi. (.444mCi/seed). The prescribed dose to the prostate was 144.0 Gy. The post-plan CT was evaluated 5-12-09 and determined that the prostate volume receiving the prescribed dose was 47% (i.e. V100%=47%) resulting in a 53 percent under dose of the prescribed dose. The patient and physician have been notified. ODH BRP will continue to evaluate this event. The licensee has initiated an internal evaluation. 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 44712 | 11 December 2008 08:34:00 | A contractor removed cesium sources from a source safe located in a storage area. The sources were removed, packaged, shipped without incident. Surveys were conducted in the safe, and the survey in the lower safe drawer revealed contamination levels greater than 5000 dpm per 100 square centimeters. The lower drawer of the safe has not been used during this recent storage and transfer of sources. The licensee reported to the state that they believed it was "legacy" contamination. Individuals involved in the source transfer were surveyed. No contamination was found. The storage area and passageway to and from the storage area were surveyed. No contamination was found. The licensee has secured the safe and the contaminated area. The area is secured and posted with "no access" signs. The state will follow up with their licensee once a decontamination service completes the decontamination of the affected areas and is ready to release the area for general use. The state notified Region 3 (Jim Lynch). |
| ENS 44397 | 8 August 2008 11:29:00 | The State received notification of a possible medical event due to an equipment malfunction. The licensee was treating a patient for rectal cancer using an HDR Nucleotron Micro Select Model 105.999 Serial 31776. The prescribed treatment consisted of the administration of 29 catheter doses of Iridium-192. During the 12th catheter dose, an equipment malfunction caused a failure of the administered treatment. The failure mode was Code 200 - "No radiation detected." The failure mode caused the unit to stop treatment by not proceeding to the next catheter. Nucleotron immediately contacted. A service technician is expected to arrive on 8/8/08 for repair of the device. Once the HDR unit is repaired, the treatment plan and written directive will be modified and treatment of the patient resumed. Patient and physician have been advised of the treatment interruption and no adverse impact is expected. The State of Ohio plans to send an inspector to the facility on 8/11/08. 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 43034 | 6 December 2006 14:11:00 | On December 6, 2006 at 9:00 AM the Ohio Bureau of Radiation Protection received a phone call from The Urology Center, LLC Ohio License number 02200310002 reporting a possible medical event that was discovered on December 5, 2006 at approximately 12:00 PM. The licensee reported that the loading of seeds into the prostate gland was not performed properly, resulting in a total shift of the seeds to the intended treatment site. This resulted in a dose to the intended treatment site to be 40 percent less than the prescribed dose. The seeds were delivered to the prostate gland. A preliminary report is expected by 4 PM December 6, 2006. A detailed written report will be due in 15 Days. A Ohio Bureau of Radiation Inspector will perform an inspection the week of December 11. The seeds used for the implant were I-125, curie content not known at this time. It is not known at this time if there will be any deleterious effects due to this treatment. The patient was notified at the time of the treatment. Ohio event number: 2006-100
This event has been reviewed by the NRC medical review committee 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 43091 | 11 January 2007 13:09:00 | On January 2, 2007, Ohio Bureau of Radiation Protection received a written report that an equipment failure of a Cobalt Teletherapy Device had occurred on December 1st while treating a patient. The sealed source did not return to the closed positron after completing treatment. The therapists immediately entered the room and returned the source to a safe configuration. The department requested additional information from the licensee on January 2 and received the additional information on January 9, 2007. It has been determined that the licensee did not perform a 24 hour notification as required in rule 3701-40-20 of the Administrative Code. The patient was exposed to less that thirty seconds exposure time and a determination was made from the additional information provided that a medical event did not occur. The unit was repaired by Neutron Products on December 8, 2006. The problem identified was an old air cylinder and detent pin which was replaced returning the unit to normal operation. The Department notified the NRC Operations Center on January 11, 2007 after determination of reporting requirements. Teletherapy unit is a Theratron-80, s/n 2640986, which is manufactured by Neutron Products. The Co-60 sealed source is 1690 Ci or 62530 GBq, model number NPTY, s/n T-1444. |
| ENS 43192 | 27 February 2007 14:04:00 | At 1405 EST on 02/26/07, the state received a report via the US Mail from Akron General Medical Center. On 09/27/06 a patient was receiving a 10 fraction dose for Mammo-site Breast Brachytherapy using a HDR afterloader with a total prescribed dose of 3400 RAD. A problem with the PLATO planning computer digitized the breast image using an incorrect treatment factor which doubled the fractional dose. The same total prescribed dose was delivered but in 5 vice 10 fractional doses. The patient was made aware of the error on 09/27/06. Tissue necrosis was observed due to the procedure, but it is being evaluated if any additional necrosis occurred due to the delivery of the total dose in 5 fractions vice the 10 planned fractional doses. The licensee is taking corrective action to prevent a reoccurrence of this type of error.
This event has been reviewed and determined to be a reportable medical event.
The State provided the following update to this report via facsimile: On September 28, 2006, the licensee notified the ODH Bureau of Radiation protection that they had an event which did not meet the reporting requirement of a medical event but they were revising their HDR program to prevent a recurrence. The Bureau requested a report that was received on February 26, 2006. The patient was to receive a total dose of 3400 rad total dose through 10 fractions of 340 rad each. The patient received 5 fractions of 680 rad for a total dose of 3400 rad. Upon review of the report it was determined by consultation with NRC Region 3 that a medical event did occur because 'Prescribed Dose' for remote afterloaders includes Total Dose and Fractionated dose. The reason for the event was the Physicist entered the wrong planning film magnification into the treatment system. The patient has experienced some tissue necrosis at the treatment site, although some necrosis is expected with this therapy (MammoSite). The necrosis may have been exacerbated by the dosage scheme. The patient is being followed by her attending physician. The patient and attending physician were notified on 09/27/2006. The Bureau conducted an inspection on November 2, 2006 and identified problems with the licensee's HDR program an additional inspection will be conducted during the week of March 5, 2007. The R3DO (Lanksbury) and FSME EO (Morell) were notified. Ohio Report OH2007-11 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 42729 | 26 July 2006 10:48:00 | The following information was provided by the state related to prostate brachytherapy which was performed on 7/10/2006 using I-125 seeds. Prostate seed implant plans are specified in kerma units (U) by default in our computer planning system. However, the ordering of seeds is specified in mCi (milliCuries). In this instance the default seed strength was not changed to mCi and a plan was developed for (the patient) to receive 111 seeds of an activity of 0.394 U per seed when 0.394 mCi was desired. The order form was completed for 111 seeds of the expected (not planned) activity of 0.394 mCi per seed. The result was an implant with seeds of activity 27% higher than planned. The overdose was noticed by the hospital on 7/12/2006. The physician, the patient, and the State of Ohio were notified on 7/13/2006. The State inspected the facility on 7/18/2006. |
| ENS 41507 | 21 March 2005 08:50:00 | A prostate implant patient at Marietta Memorial Hospital was to have received 98 Iodine-125 seeds, 0.310 millicuries per seed, but instead received 83 iodine-125 seeds and 15 palladium-103 seeds, 1.2 millicuries each (palladium-103 is accelerator produced). The patient received 98% of the planned dose. The holders for the iodine-125 seeds and the palladium-103 seeds are similar in shape and size. The State of Ohio Bureau of Radiation Protection received the above information on 03/16/05 around 1300 hours. The Ohio Bureau of Radiation Protection is investigating this event. |
| ENS 41358 | 26 January 2005 12:13:00 | The following information is a preliminary report provided to the Ohio Department of Health Bureau of Radiation Protection concerning a patient at the Riverside Methodist Hospital in Columbus, Ohio that was administered radioactive iodine while pregnant. It has been brought to our attention that a patient that had been treated for hyperthyroidism at our facility was in fact pregnant at the time of the administration. The patient had an uptake study performed on 11/2/04 (205 microcuries of I-123 sodium iodine) pursuant to a diagnosis of hyperthyroidism. The patient was administered 12.7 millicuries of I-131 sodium iodine on 11/16/04 as treatment. The patient was counseled by the Authorized User prior to the administration and received written consent from the patient that she was not or could not be pregnant at that time. A pregnancy test was not performed to confirm or deny this fact. The fact that the patient was pregnant was brought to our attention when she saw her family practice physician (who was the referring physician for the uptake and hyperthyroidism treatment procedures) for complaints of abdominal pain. A radiograph of the abdomen was taken and the pregnancy discovered. This occurred sometime within the past week. The fact that the patient was pregnant was relayed to the Authorized User, who, in conjunction with the referring physician, referred the patient to a prenatal specialist to determine the age of the fetus. The specialist determined the delivery date to be 4/25/05, which meant the age of the fetus at the time of the I-131 administration was 17 weeks. This determination was made on January 24, 2005, and the RSO's staff called the (Ohio Department of Health) to report the event after gathering information for a dosimetry study at approximately 10 AM, 25 January, 2005. The dosimetry estimate for the fetus was approximately 2.0432 rad to the whole fetus and 22,400 rad to the fetal thyroid from both the I-123 and I-131 administrations. It should be noted that the patient underwent a CT angiogram on 9/24/04 (fetal age 8 weeks), but that this dose and the abdominal x-ray taken last week were not added to the fetal whole body dose since specific technique factors were not available for these studies which were performed elsewhere. The patient will be notified of the treatment plan for the continuation of the pregnancy today or tomorrow, once the prenatal specialist receives the dosimetry estimate the RSO provided the Authorized User. The referring physician has been in close contact with the Authorized User throughout this process. The Ohio Department of Health considers this an "Abnormal Occurrence" and will be conducting an investigation commencing this Friday (1/28/05). Ohio Dept of Health Report # 2005-001 |
| ENS 40742 | 13 May 2004 09:17:00 | On May 10, 2004 two patients were scheduled for administration of diagnostic dosages of radioiodine. Patient A was scheduled to have administered 2 millicuries I-131 Na - l for a thyroid cancer ("CA") workup to determine the appropriate I-131 Na - l therapeutic dosage for treatment of thyroid cancer. Patient B was scheduled to have administered 200 microcuries of I-123 Na - l for a thyroid uptake and scan to determine the appropriate therapeutic dosage of I-131 Na - l for hyperthyroidism. Both patients were small, elderly, Caucasian women and both had been previously treated at TUH Nuclear Medicine. Patient B (hard of hearing) was checked in as Patient A and responded affirmatively to being addressed as Patient A. The technologist believed he knew the patient, believed the correct patient responded so he administered the 2 millicuries of I-131 Na - I to Patient B. The error was discovered when an Administrative Assistant in the department addressed the patient as Patient A and the patient responded she was Patient B. The prescribing physician informed Patient B of the misadministration during her appointment on May 11, 2004. The prescribing physician informed the referring physician's office of the misadministration on May 11, 2004. This incident occurred because the technologist did not follow departmental, hospital, Radiation Control and Safety Program and QMP policies regarding proper identification of patients. All policies require technologists use two separate methods for verifying the identification of the patient. The technologist thought he knew the patient; however, he was incorrect with this assumption. In addition, the technologist did not use an accepted second method of identifying the patient. The second method of identification used by the technologist was estimating the patient's apparent age with the date of birth listed. No adverse effect is expected for the patient. Patient B was scheduled to receive a therapeutic dose of I-131 Na - I the day after the misadministration occurred. The prescribing physician indicated he would administer the calculated treatment dose minus the 2 millicuries administered from the misadministration. On May 11, 2004 the appropriate dosage for patient B's hyperthyroid treatment was determined to be 17 millicuries. Patient B was administered 15.56 millicuries (prescribed as 17 millicuries - 2 millicuries or 15 millicuries) on May 11, 2004. Technologists shall be expected to strictly follow hospital, departmental, Radiation Control and Safety Program and QMP policies requiring patient identification using a minimum of two identification methods. Identification of patients by a member of hospital staff, such as the technologist performing the procedure, should be eliminated as an approved mechanism for one of the two identification methods. |
| ENS 40575 | 8 March 2004 10:15:00 | During a therapeutic procedure using I-125 Gliasite from 2/28 - 3/1, the state licensee administered an under dose of 24%. The therapist calculated a dwell time of only 97 hours when the prescribed dwell time was 120 hrs for treating a brain tumor. This resulted in the patient receiving 5,300 rads instead of the prescribed 7,000 rads. Both the patient and the referring physician were notified. The licensee will make up for the under dosage by using a linear accelerator. |
| ENS 40464 | 22 January 2004 09:29:00 | On 11/20/03 a 19 year old female patient received 140.1 millicuries I-131 for thyroid carcinoma as prescribed. At the time she was unaware and had completed the required forms indicating she was not pregnant. On 12/5, 12/8 and 12/11/03 quantitative tests confirmed that she was pregnant. The results were provided to her endocrinologist who recommended that a fetal dose calculation be performed. The hospital was notified and their consultant informed the endocrinologist that the fetus would have received 19.6 rads. The Endocrinologist sent the results to the Center for Human Genetics at University Hospital in Cleveland where as assessment was performed that the pregnancy could safely continue. The Ohio Bureau of Radiation was informed on 1/16/04 and submitted the information to the NRC Region III office. NRC Region III (Lynch) recommended making a telephonic notification due to the incident meeting the criteria of an AO even though Ohio is not required to conform with the revised reporting requirements for a period of three years (October 2005) after the final rule is issued. Hillcrest Hospital has implemented pregnancy testing for child bearing age female patients receiving radiation therapy. |
| ENS 40413 | 24 December 2003 09:34:00 | On 12/23/2003 at 1600 hours EST the licensee notified the Ohio Department of Health, Bureau of Radiation Protection, of the following information regarding a patient undergoing intravascular brachytheraphy treatment: On December 22, 2003 during a treatment with a Novoste Beta-Cath 3.5 French IVB System, the source did not travel the entire way to the treatment site and was 3 centimeters proximal to the treatment site. The immediate cause of the event was a small kink in the delivery catheter which kept the source train from traveling to the correct site, even though the kink was not substantial enough to affect the flow of sterile water used to send/retrieve the sources. The error was discovered the next day during medical physics quality checks and reported to Ohio Department of Health, Bureau of Radiation Protection. An investigation will be performed the week of December 29, 2003. The dose to the unintended site was identified as 1840 rad (18.4 Gy) from a 0.05378 curie, Sr-90, sealed source. The attending physician has been notified. The intravascular brachytheraphy unit is a Novoste, model TDA-1040, serial number 91828. The Ohio Department of Health, Bureau of Radiation Protection reference number for this event is 2003-126. |
| ENS 40235 | 9 October 2003 13:52:00 | The Ohio Bureau of Radiation Protection was notified on 10/9/03 that a CPN Model MC portable moisture density gauge, S/N MD20606630, was stolen from an employee's vehicle parked overnight at his residence. The gauge contains two (2) sources; 9.7 millicuries Cs-137 and 49.8 millicuries Americium-241/Beryllium. The theft was discovered earlier this morning and reported to the State at 1259 EDT. The State is dispatching a field investigator for followup. The licensee informed the local Police Department of this incident. |