The following information was supplied by the licensee:
Two patients involved in what we now think to be reportable events.
1. A.M. 2-23-04 to 2-24-04
2. R.M. 3-01-04 to 3-02-04
In both cases the patients were being treated for endometrial cancer with brachytherapy. A new Wang vaginal applicator was used. The tandem was loaded with incorrect size sources (of Cs-137) which then had the ability to slide out of the intended treatment position through the placement spring when the patient would sit in a more up-right position. With the sources out of position they would irradiate the patients inner thigh. The dose to the thigh had to be estimated based on estimated time the patient was in an up-right position and the effect seen on the skin.
At the time these incidents took place it was not felt that reportable events had taken place because of the calculated exposure to the thigh, patient symptoms, and the interpretation of 35.3045 (a) (1)(2), (3).
One of the patients (A.M.) returned recently (1/05) with an ulcer at the area of thigh exposure. This has caused the radiation therapy staff to reevaluate their dose estimation to the patients. After review, it is believed that reportable events my have occurred based on 35.3045 (A) (3).
This conclusion was formulated on 3-25-05 after a staff meeting and 1 received the final letter from the physician today 3-28-05.
The tandem manufacturer recommends 3M seeds and the facility used Amersham seeds which resulted in the seeds shifting. A total of 5 patients were treated. The initial estimates determined that the exposure was less than the reportable limit. All the patients were notified of the exposure.
One of the two overexposed patients is responding well to treatment. The other patient may have received the higher dose. The remaining three patients appear to have received less than the reportable dose.
- * * UPDATE FROM JOHN SCHEU TO JEFF ROTTON ON 4/1/2005 AT 1608 * * *
Discussion between the licensee and NRC Region 3 inspectors determined that a third patient should be added to this event:
3. K.B. 3-19-04 to 3-22-04
Notified R3DO (Riemer) and NMSSEO (Collins).
- * * UPDATE FROM JOHN SCHEU TO HOWIE CROUCH ON 4/5/05 AT 1833 EDT * * *
Discussion between the licensee and NRC Region 3 inspectors determined that a fourth and fifth patient should be added to this event:
4. D. T. 1/26/04 to 1/27/04
5. M. S. 2/18/04 to 4/21/04
Notified R3DO (O'Brien) and
NMSS EO (Leach).