ENS 46272
ENS Event | |
|---|---|
04:00 Dec 2, 2004 | |
| Title | Agreement State Report - Unreported Medical Prostate Therapy Underdoses Discovered During Audit |
| Event Description | The following information received via email is historical and was discovered/reported to the State of Ohio on 04/27/2010:
NOTE: The information entered in this event notice was received from the licensee as a result of an audit ordered by the Ohio Department of Health for all brachytherapy procedures performed by the licensee since November 2004. This incident was referenced in Ohio NMED Item # OH100003. [NMED Item Number: 100113 - Ohio Agreement State Report EN #45750] On 12/2/04 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 160 Gray [107.4 Gray actually delivered] to the prostate. A post implant dose calculation showed a underdose to the prostate greater than 20% of the prescribed dose; however, the licensee determined the dose to be clinically adequate. No further therapy was planned at that time. [Ohio NMED Item # OH100012] On 12/14/04 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 108 Gray [66.27 Gray actually delivered] to the prostate. Post implant dosimetry showed a low dose distribution to the base of the prostate, which was not felt to be clinically significant. No further therapy was recommended at that time, since the patient also received external beam radiotherapy. [Ohio NMED Item # OH100013] On 7/3/07 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 160 Gray [101.82 Gray actually delivered] to the prostate. A post implant dose calculation showed a underdose to the prostate greater than 20% of the prescribed dose; however, the licensee determined the dose to be clinically adequate. There was limited dose distribution at the gland base. No further therapy was planned at that time. [Ohio NMED Item # OH100014] On 1/11/05 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 160 Gray [101.7 Gray actually delivered] to the prostate. A post implant dose calculation revealed a suboptimal dose distribution to the base of the prostate gland. No further therapy was planned at that time. [Ohio NMED Item # OH100015] On 7/14/05 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 160 Gray [57.4 Gray actually delivered] to the prostate. Following the final dosimetry testing in 2005, the patient and the referring urologist were notified of a clinically suboptimal dose to the base of the prostate. Post implant prostate volume on which the dosimetry was calculated was 40% greater than the intraoperative prostate volume. Thus, dosimetry was inaccurate due to gland edema. The patient and the referring urologist opted for close monitoring of the prostate and PSA levels without additional therapy. No further therapy was planned at that time. [Ohio NMED Item # OH100016] On 4/17/07 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 108 Gray [58.6 Gray actually delivered] to the prostate. Seed implant was utilized as a boost to the prostate gland following IMRT. Post implant dosimetry showed a suboptimal dose distribution at the base; however, satisfactory dose was observed about the mid gland where biopsy proven adenocarcinoma was present. No further therapy was planned at that time. [Ohio NMED Item # OH100017] On 9/23/05 the licensee performed a prostate seed implant with I-125 seeds prescribed to deliver a dose of 108 Gray [79.4 Gray actually delivered] to the prostate. The patient received external beam radiation therapy (4500cGy) and seed implant was utilized as a boost to the prostate gland following IMRT. Post implant dosimetry indicated a clinically satisfactory dose distribution. No further therapy was planned at that time. [Ohio NMED Item # OH100018] 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. |
| Where | |
|---|---|
| Mercy St Vincent Medical Center Toledo, Ohio (NRC Region 3) | |
| License number: | 02120490000 |
| Organization: | Ohio Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+50916.93 h2,121.539 days <br />303.077 weeks <br />69.746 months <br />) | |
| Opened: | Stephen James 15:56 Sep 23, 2010 |
| NRC Officer: | Mark Abramovitz |
| Last Updated: | Sep 23, 2010 |
| 46272 - NRC Website | |
Mercy St Vincent Medical Center with Agreement State | |
WEEKMONTHYEARENS 462722004-12-02T04:00:0002 December 2004 04:00:00
[Table view]Agreement State Agreement State Report - Unreported Medical Prostate Therapy Underdoses Discovered During Audit 2004-12-02T04:00:00 | |