Semantic search
| Entered date | Event description | |
|---|---|---|
| ENS 45011 | 23 April 2009 11:46:00 | The following was received from the agreement state with a state control number of KY0901: At 1400 on 4/22/2009, the RSO of a medical licensee reported the misadministration of a radiopharmaceutical to a seven-month-old infant. The infant was scheduled for a renal scan and was ordered to receive a 2 mCi dose tagged with Tc-99m. The patient was inadvertently administered a 35 mCi dose of Sestamibi/Tc-99M. Event date: 4/22/2009. Discovery date: 4/22/2009. Report date: 4/22/2009. Licensee Reporting Party Information: University of Kentucky, Lexington KY 40506, License number: 202-049-22. Site of event: Lexington, KY. Event type: MD2 - Medical event. Event cause: Human error. The patient was informed on 4/22/2009. The intended diagnostic study was renal-glomerular filtration with dimercaptosuccinic acid (DMSA) radiopharmaceutical, with a 2 mCi (74 MBq) Tc-99m radionuclide. The given diagnostic study was cardiac perfusion with sestamibi/cardiolite radiopharmaceutical, with a 34.9 mCi (1291.3 MBq) Tc-99m radionuclide. The dose exceeded the prescribed dose by 1650%. It is estimated that the heart received a dose of 2.84 rem, and the whole body does was 6.84 rem. The effect on the patient is unknown at this time. 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 46476 | 13 December 2010 15:51:00 | The Kentucky Radiation Health Branch was notified by the U.S. NRC by email on October 4, 2010 of a possible medical event occurring in the Commonwealth. There was no identification of the licensee involved. After extensive research, the Radiation Health Branch identified the licensee where the alleged medical event occurred. During an inspection of the facility, a review of medical documents identified a medical event involving the therapeutic treatment of prostate cancer with Pd-103 seeds. The treatment plan called for 100 Pd-103 seeds with an activity of 1.237 mCi per seed. The pretreatment plan of D90=132.78 Gy. The post treatment plan indicated the prostate received a D90=5.18 Gy. The licensee has not acknowledged a medical event. The patient involved has never been notified by the licensee. He was advised of the misadministration by another physician during a second opinion medical evaluation. Violations have been issued to the licensee. (An) evaluation (by the state) is ongoing.
The following update was received from the Commonwealth via fax: The written directive had a prescribed dose for Pd-103, 100 Gy, act/seed 1.6 U, number of seeds 100. Notified R1DO(Holody) and FSME(Villamar).
The Commonwealth of Kentucky performed an inspection of Our Lady of Bellefonte Hospital on 11/30/2010 and found 35 additional cases of medical misadministration during prostate seed implantation by one doctor. The date of the misadministration occurred from 10/3/2001 to 2/24/2009. No written directive for the dose prescribed or delivered was found for 14 of the cases with the remainder of the cases not having the post implant dose recorded. There was no post CT scan on 17 cases, and D90 doses ranged from 0% to 162% of the prescribed dose. The physician was notified on all of these cases however, none of the patients were notified. Notified the R1DO (Welling) and FSME (Jackson). 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 47011 | 1 July 2011 14:13:00 | The state found three cases of prostate seed (Pd-103) medical misadministration during an inspection on 1/14/2011. These cases are related to one doctor. 2/18/2008: 100 Gy prescribed, 70.24 Gy administered 4/8/2008: 125 Gy prescribed, 71.6 Gy administered 3/17/2009: 100 Gy prescribed, 160.8 Gy administered The physician was notified of the misadministration however the patients were not notified. 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 47069 | 18 July 2011 16:38:00 | The following information was received by e-mail: A routine inspection was performed of the licensee on July 11 and 12, 2011. Based on records reviewed at the time of inspection and additional documentation provided to the Kentucky Radiation Health Branch on July 15, 2011. Three unreported Medical Event(ME)s appeared to have occurred during the past three years. 1. On June 16, 2008 a Written Directive(WD) signed by an Authorized User (AU) for the administration for a total activity of 192.00 U (148.492 mCi) and a Prescription Dose of 125.0 Gy of Pd-103 seeds to the prostate. Manufacturer: Theragenics Model Number: Not Available Seed Lot No: NOT AVAILABLE Source Activity: 2.000 U (1.547 mCi )per seed Number of Seeds (Sources): 96 Based on the licensees use of the nationally recognized Report of AAPM (American Association of Physicists in Medicine) Task Group Report No. 64 for determining the dose received by the prostate a ME was identified. The post operative CT indicated the prostate received: D90 of 81.17 Gy (64.94%) of the prescribed dose. D100 of 43.71 Gy (34.97%) of the prescribed dose. 2. On March 23, 2009 a Written Directive(WD) signed by an Authorized User for the administration for a Total Activity of 133.560 U (103.295 mCi) and a Prescription dose of 90. Gy of PD-103 seeds to the prostate. Manufacturer: Theragenics Model Number: 200 Seed Lot No: 0910E Source Activity: 1.590 U (1.230 mCi) per seed Number of Seeds (Sources): 84 Based on the licensees use of the nationally recognized Report of AAPM Task Group Report No. 64 for determining the dose received by the prostate a ME was identified. The post operative CT indicated the prostate received: D90 of 55.41 Gy (61.57% ) of the prescribed dose. D100 of 28.03 Gy (31.15% of the prescribed dose). 3. On April 12, 2010 a Written Directive (WD) signed by an Authorized User for the administration for a Total Activity of 140.736 U (108.848 mCi) and a Prescription Dose of 125.0 Gy of PD-103 seeds to the prostate. Manufacturer: Theragenics Model Number: 200 Seed Lot No: 0910E Source Activity: 2.199 U (1.701 mCi ) per seed Number of Seeds (Sources): 64 Based on the licensees use of the nationally recognized Report of AAPM Task Group Report No. 64 for determining the dose received by the prostate a ME was identified. The post operative CT indicated the prostate received: D90 of 70.71 Gy (56.57% )of the prescribed dose. D100 of 34.21 Gy (27.36% of the prescribed dose). The licensee and the RSO (Radiation Safety Officer) were unaware the three procedures were reportable ME's. The RSO and the AU reviewed the Pre and Post implant plan and the AU was satisfied to follow the patients progress with repeated PSA testing. The licensee is currently reviewing the findings and implementing preventive measures agreed to by the licensee and the (Agreement State). 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 47175 | 19 August 2011 15:39:00 | Kentucky provided the following information via e-mail: On July 15, 2011, an 82 year old male patient was scheduled for a therapeutic dose of I-131, 15 mCi for the treatment of subclinical hyperthyroidism with (the prescribing physician). The therapeutic dose received from the radiopharmacy was assayed prior to administration and indicated an amount of 19.9 mCi. The technologist assaying the dose contacted (the physician) concerning the difference in the amount ordered and the amount received. (The physician) chose to accept the dose and administer it to the patient based on the patient's age and symptomatic subclinical hyperthyroidism and enlarged lobe. (The physician) accepted the dose clinically but did not document this on the written directive prior to administration. The change in dose is documented in (the physician's) dictation, completed on July 15, 2011 at 1:44 p.m., acknowledges the change in the dose administered and it is documented that the technologist informed him of the difference in dose and his acceptance and why this amount was acceptable. The failure to change the written directive prior to administration was not identified until August 8, 2011 during OLBH's (Our Lady of Bellefonte Hospital) annual audit conducted by a Medical Physicist. (The) RSO and the Director of Radiology contacted the RHB (Radiation Health Branch) on August 9, 2011 for notification of the medical event. Contributing Factor: Failure to change the written directive prior to administration of the I-131. Corrective Actions by Licensee: A policy and procedure review was conducted. The Quality Management form and Written Directive used with administration of I-131 therapies was reviewed and updated to include an area that requires explanation of any dose that differs from the prescribed dose being administered and the signature of the AU (authorized user) confirming the change in dose prior to administration. 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 47980 | 31 May 2012 15:20:00 | The following report was received via e-mail: During a routine inspection, three unreported (prostate brachytherapy) medical events were identified. Case One: Implant Date: 6/4/2009 Prescribed dose: 145Gy to the prostate Post implant CT dosimetry: V100 (the volume of the prostate receiving 100% of the prescribed dose) totaled 69.71% Source: I-125 encapsulated seeds Vendor: IsoAid Model Number: IAI-125A Activity per seed: 0.330 mCi Number of seeds implanted: 69 Case Two: Implant Date: 6/19/2009 Prescribed dose: 145Gy to the prostate Post implant CT dosimetry: V100 (the volume of the prostate receiving 100% of the prescribed dose) totaled 62.77% Source: I-125 encapsulated seeds Vendor: IsoAid Model Number: IAI-125A Activity per seed: 0.330 mCi Number of seeds implanted: 80 Case Three: Implant Date: 10/29/2009 Prescribed dose: 145Gy to the prostate Post implant CT dosimetry: V100 (the volume of the prostate receiving 100% of the prescribed dose) totaled 65.34% Source: I-125 encapsulated seeds Vendor: IsoAid Model Number: IAI-125A Activity per seed: 0.330 mCi Number of seeds implanted: 84
D90 is defined as minimum dose received by 90% of CT-defined prostate volume Case 1 D90 = 72.80% of 145Gy Case 2 D90 = 58.86% of 145Gy Case 3 D90 = 54.00% of 145Gy Notified R1DO (Cahill) and FSME Events via email. 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 48593 | 14 December 2012 12:41:00 | The following was received from the Commonwealth of Kentucky via email: During a prostate implant the radiation oncologist and urologist encountered issues due to the prostate size, location and pubic arch. Some of the needles became bent during the procedure and the decision was made to abort the implant. While completing the procedure the radiation oncologist revised the written directive to reflect what had occurred and revised the prescribed dose based on the complications. The patient received 64.51% of the intended dose. The procedure used 14 seeds manufactured by IsoAid with an activity of 0.350 mCi of I-125. 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. |