ENS 50967
ENS Event | |
|---|---|
05:00 Mar 12, 2015 | |
| Title | Agreement State Report - Treatment Underdose |
| Event Description | The following was received from the Commonwealth of Kentucky via email:
On 19 March 2015, the patient was receiving an HDR cylinder treatment using the HDR Ir-192 source for treatment of her vaginal cuff. The prescribing physician inserted the vaginal cylinder in the patient's vagina until resistance was present, indicating the tip of the cylinder had reached the vaginal cuff. Before each treatment is delivered a radiographic image of the inserted treatment device is reviewed to ensure consistent device location across each fraction (this image is not intended as a placement verification for treatment). Comparison of images taken on 19 March 2015 and 12 March 2015, revealed that the cylinder placement during treatment on 12 March 2015, was 3cm distal to the cylinder placement on 19 March 2015, implying the dose delivered during the patient's first treatment on 12 March 2015 was located 3cm distal to its intended location. The effect of relocating the cylinder to a 3cm distal position has the effect of under dosing the vaginal cuff, while providing additional dose to the vaginal wall in an unintended location. The RHB [Kentucky Radiation Health Branch] has requested additional dose information to the vaginal wall area. Some of the vaginal wall is dosed during this procedure just not in this location. The prescribing physician has deemed the additional dose to the vaginal wall as medically insignificant. Vaginal cuff treatments are planned to deliver a prescribed dose to a reference line located 0.5cm outside the cylinder wall. A new treatment plan depicting the true location of the 12 March 2015, treatment has been generated and a comparison of the dose to the reference line has been made to estimate the extent to which the vaginal cuff has been under dosed. The average dose delivered to the vaginal cuff area was 80% lower than intended. Due to the fact that the dose to the vaginal cuff from the first treatment is so low, the physician has decided to ignore the patient's first treatment and change the patient's prescription to deliver the intended dose over the remaining fractions. The authorized user notified the patient upon completion of her treatment on 19 March 2015. Two possible scenarios have been determined to be the most likely cause of the event: 1. The first is that the cylinders used for treatment are segmented. Typically 4 segments are locked together into one larger cylinder. The larger cylinder is then attached to a clamping device that allows the cylinder to be locked into position after the authorized user (AU) inserts the device into the patient. During this particular treatment only 3 segments were used to form the cylinder leaving less space for the clamping device to attach to the cylinder. As the AU was inserting the cylinder, the cylinder clamping device may have pushed up against the patient's perineum prematurely causing resistance to further insertion prompting the AU to believe the cylinder had reached the vaginal cuff. a. In order to prevent future occurrences from happening, the staff involved will be required to always use all 4 segments when constructing a cylinder. 2. The other possibility is due to the non-compliance of the patient herself. As the cylinder was being inserted, the patient was having a hard time remaining still. Once the cylinder was locked into place, it is possible that the patient pulled away from the cylinder a small amount causing the change in location. This is believed to be the most likely scenario based on the patient's common reaction and motion upon insertion of the cylinder. a. In order to minimize a patient's ability to adjust the cylinder position, staff will be instructed to pay close attention to the patient's movements and additional imaging of the device location will be taken if movement is a concern. A phone call was made to the KY Radiation Health Branch of the incident with intent to meet the notification requirements to the KY RHB. The Physicist had left a phone message but did not report to a person. There is no record of this message however a record of a phone call is noted received 19 March 2015 at 1450 EDT. Upon receipt of an email to the Radiation office, the required 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notification is made to the NRC Headquarters Operations Officer. 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. Kentucky Incident # 150002 |
| Where | |
|---|---|
| Norton Suburban Hospital Louisville, Kentucky (NRC Region 1) | |
| License number: | 202-099-27 |
| Organization: | Kentucky Dept Of Radiation Control |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+653.17 h27.215 days <br />3.888 weeks <br />0.895 months <br />) | |
| Opened: | Angela Wilbers 10:10 Apr 8, 2015 |
| NRC Officer: | Daniel Mills |
| Last Updated: | Apr 8, 2015 |
| 50967 - NRC Website | |
Norton Suburban Hospital with Agreement State | |
WEEKMONTHYEARENS 509672015-03-12T05:00:00012 March 2015 05:00:00
[Table view]Agreement State Agreement State Report - Treatment Underdose ENS 485302012-11-21T06:00:00021 November 2012 06:00:00 Agreement State Agreement State Report - Medical Event ENS 441932008-04-28T05:00:00028 April 2008 05:00:00 Agreement State Kentucky Agreement State Report - Medical Event - Patient Received Incorrect Dose of I-131 2015-03-12T05:00:00 | |