ENS 39941
ENS Event | |
|---|---|
04:00 Jun 12, 2003 | |
| Title | Discovery That Part of the Implanted Seeds Were Not in the Proper Site |
| Event Description | A patient was referred for treatment, due to reoccurring prostate cancer, to the hospital where he had previously had treatment. Seeds were implanted around May 2001. A scan of the previous treatment of implanted seeds determined that many of the seeds were not located in the prostate, but in adjacent tissue where they would have been ineffective in treatment. Also, a review of the records indicated a scan was performed in early 2002, but was not followed up on. The patient and referring physician have been informed. The hospital is conducting an investigation into the event and also developing a plan to provide appropriate treatment for the patient.
Post-op dosimetry on one patient was determined to be a misadministration. The dose that covered the prostate was more than 20 percent different from the prescription as well as the penile bulb dose being close to 50 percent of the prescription dose. Efforts are being made to contact the affected patient. The licensee will continue efforts to obtain post-op dosimetry on the rest of the patients related to this incident so that evaluations for misadministration can be performed. Notified R1DO (Della Greca) and NMSS EO (Pierson).
Post-op dosimetry for two patients were determined to be a misadministration. The patients had their prostates treated some time in the year 2001. The iodine-125 seeds were placed 2 to 3 centimeters below the area where they were supposed to be located. The improper location of the iodine-125 seeds caused more than 50% of the prescribed dose to be delivered to an un-intended organ. The patients will be notified. Notified R1DO (Dan Holody) and NMSS EO (Trish Holahan).
Two additional patients of a group of seven were identified as having received a misadministration of iodine-125 to an unintended organ. The patients will be notified of this misadministration. The licensee is in the process of clarifying and document the issues related to this incident. Notified R1DO (James Moorman) and NMSS EO (Tom Essig).
Another patient has been identified who received a misadministration of iodine-125 to the prostate. The prescribed dose was 144 Gy, and it was delivered using 76 seeds and 27 needles as planned prior to the implant date. After reviewing the CT, which was done on Feb. 27, 2001, the V100 of the prostate received 29% of the prescribed dose. The penile bulb at 72 Gy received 44.8%. The licensee indicated that they have looked into 8 patients who may have been misadministered, of which, one was not declared a misadministration. The other seven appear in this notification. There are 23 total patients that the licensee intends to review. Notified R1DO (Clifford Anderson) and NMSS EO (Fred Brown).
Twelve more patients have been added to the number of patients. Patients are identified by a six digit number. Patient# [deleted]- On this date, March 21, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 77 seeds and 26 needles as planned prior to the implant, The V 100 of the prostate received 39% of the prescribed dose and the V50 of the penile bulb received 88%. Patient# [deleted]- On this date, May 23, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed close was delivered using 53 seeds and 18 needles as planned prior to the implant. The V100 of the prostate received 62% of the prescribed dose and the V50 of the penile bulb received 57%, Patient# [deleted]- On this date, December. 13, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 86 seeds and 21 needles as planned prior to the implant. The V 100 of the prostate received 70% of the prescribed dose and the V50 of the penile bulb received 99%. Patient# [deleted]- On this date, February 22, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 77 seeds and 25 needles as planned prior to the implant. The V100 of the prostate received 52.5% of the prescribed dose and the V50 of the penile bulb received 80%. Patient# [deleted]- On this date, March 15, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 67 seeds and 27 needles as planned prior to the implant. The V 100 of the prostate received 59% of the prescribed dose and the V50 of the penile bulb received 86.5%. Patient# [deleted]- On this date, July 5, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 62 seeds and 21 needles as planned prior to the implant. The VI 00 of the prostate received 49% of the prescribed dose. Patient# [deleted]- On this date, February 8, 2001, the former physician, prescribed a dose of 144-Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 45 seeds and 18 needles as planned prior to the implant. The V 100 of the prostate received 68% of the prescribed dose. Patient# [deleted]- On this date, September 5, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 58 seeds and 20 needles as planned prior to the implant. The V100 of the prostate received 59.5% of the prescribed dose. Patient# [deleted]- On this date, May 31, 2001, the former physician, prescribed a dose of 14-4Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 60 seeds and 17 needles as planned prior to the implant. The V1 00 of the prostate received 68% of the prescribed. Dose. Patient# [deleted]- On this date, January 22, 2001, the former physician, prescribed a dose of 144Gy to the prostate using I-125 seeds. The prescribed dose was delivered using 54 seeds and 3, 8 needles as planned prior to the implant. The V100 of the prostate received 73% of the prescribed dose, Patient# [deleted]- On this date, January 10, 2001, the former physician, prescribed a dose of 144Gy to the prostate using I-125 seeds. The prescribed dose was delivered using 58 seeds and 19 needles as planned prior to the implant. The VI 00 of the prostate received 54% of the prescribed dose. Patient# [deleted]- On this date, June 21, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds, The prescribed dose was delivered using 82 seeds 28 needles as planned prior to the implant, The V 100 of the prostate received 73% of the prescribed dose. Notified R1DO (Glenn Meyer) & NMSS EO (Linda Psyk).
Patient # [deleted] - On 10/3/2001, the former physician prescribed a dose of 144 Gy to the prostate using I-125 seeds. The dose was delivered using 67 seeds and 23 needles as planned prior to the implant. The V100 of the prostate received 72.5% of the prescribed dose. Patient # [deleted] - On 10/4/2001, the former physician prescribed a dose of 144 Gy to the prostate using I-125 seeds. The dose was delivered using 74 seeds and 30 needles as planned prior to the implant. The V100 of the prostate received 66.7% of the prescribed dose. Notified R1DO (Pam Henderson) and NMSS EO (Tom Essig) |
| Where | |
|---|---|
| Guthrie Health Care Sayre, Pennsylvania (NRC Region 1) | |
| License number: | 37-01893-01 |
| Organization: | Guthrie Health Care |
| Reporting | |
| 10 CFR 35.3045(a)(1) 10 CFR 35.3045(a)(3) | |
| Time - Person (Reporting Time:+106.33 h4.43 days <br />0.633 weeks <br />0.146 months <br />) | |
| Opened: | Joon Park 14:20 Jun 16, 2003 |
| NRC Officer: | Fangie Jones |
| Last Updated: | Sep 5, 2003 |
| 39941 - NRC Website | |
Guthrie Health Care with 10 CFR 35.3045(a)(1), 10 CFR 35.3045(a)(3) | |
WEEKMONTHYEARENS 399412003-06-12T04:00:00012 June 2003 04:00:00
[Table view]10 CFR 35.3045(a)(1), 10 CFR 35.3045(a)(3) Discovery That Part of the Implanted Seeds Were Not in the Proper Site 2003-06-12T04:00:00 | |