ENS 48864
ENS Event | |
|---|---|
05:00 Mar 27, 2013 | |
| Title | Agreement State Report - Under Dose in Brachytherapy Treatment Due to Use of Wrong Length Guide Wire |
| Event Description | The following information was provided by the State of Texas via email:
On March 28, 2013, the Agency [Texas Department of Health] was notified by the licensee that a medical event occurred on March 27, 2013. The licensee stated that the wrong length guide wire was used during 3 of 4 HDR [High-Dose Rate Brachytherapy] treatments. The error was discovered after the third treatment. The Radiation Safety Officer (RSO) stated the desired area of treatment was under dosed by more than 50 percent. The treatment plan prescribed 2400 cGy over 4 treatments. He stated that the patient and their physician were notified as soon as the error was discovered. The RSO is not at the facility and is trying to gather the information on the event over his phone. The licensee has suspended all HDR treatments until their process and procedures have been reviewed. Additional information will be provided as it is received in accordance with SA - 300. Texas Incident #: I-9059 The following information was provided by the State of Texas via email: On April, 9, 2013, the licensee provided the following information: The Physicist of record retrieved tube connectors from the HDR supplies on shelves in the dosimetry area. The tube/connectors were stored, coiled in Ziploc bags. The Physicist selected green tubes when he saw the black tubes used previously were not on the shelf. He was unaware that there were two sets, each a different length when he selected the green set. The black tubes measure 120cm in length and the green tubes measure 132cm. The Senior Physicist, who was on vacation during the first two out of the four treatments, stored the black tube set in a drawer across the room. Physicist selected tubes which attached to the patient's treatment device. The Physicist planned the patient's treatment with the treatment lengths (119.9 cm) stated in our facility's HDR tandem and ring treatment planning procedure and forms but used the 132cm tube for the treatment delivery for three out of four fractions. Only the black tubes were used historically in tandem and ring HDR procedures and since their given length were known, they were not measured at the time of treatment delivery. The green tubes were also not measured prior to treatment delivery. The Physician of record saw the green tubes and believed their use was intentional. This medical event meant the patient's tissue to be treated (cervix) received less total radiation dose than that prescribed: 1,390 cGy (mean dose delivered) vs. the 5,139 cGy the cervix would have received over the four treatments. This is more than a 50 cGy (50 rem) effective dose equivalent difference to the cervix. In addition, the mean total dose delivered to the cervix over the four treatments differed from the prescribed dose by more than 20% (42.1% is the actual variance) and the delivered dose for at least one of the fractions differed by more than 50% from the prescribed dose (fraction #1 cervix mean dose delivered was 42.5 cGy vs. the 1,192.4 cGy expected) (fraction #2 cervix mean dose delivered was 34.6 cGy vs. the 1,416.3 cGy expected) and (fraction #3 cervix mean dose delivered was 45.2 cGy vs. the 1,262.2 cGy expected). The patient's urethra received a mean dose of 1,607 cGy for the four fractions. The maximum dose to 1 cc of the urethra for the four fractions was 1,849 cGy. The patient's anterior vagina received a mean dose from the four fractions of 1,549 cGy. The maximum dose to 1 cc of the anterior vagina for the four fractions was 3,049 cGy. The Agency [Texas Department of Health] has requested additional information from the licensee. Additional information will be provided in accordance with SA 300. Notified R4DO (Deese) and FSME Events Resource via email.
The reference to a guide "wire" in the initial report was incorrect. An incorrect guide "tube" was used. Additionally, the title should have stated "GUIDE TUBE. Notified the R4DO (Walker). 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 | |
|---|---|
| Rosa Of North Dallas Llc Dallas, Texas (NRC Region 4) | |
| License number: | 06186 |
| Organization: | Texas Department Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+36.97 h1.54 days <br />0.22 weeks <br />0.0506 months <br />) | |
| Opened: | Art Tucker 17:58 Mar 28, 2013 |
| NRC Officer: | Steve Sandin |
| Last Updated: | May 17, 2013 |
| 48864 - NRC Website | |
Rosa Of North Dallas Llc with Agreement State | |
WEEKMONTHYEARENS 488642013-03-27T05:00:00027 March 2013 05:00:00
[Table view]Agreement State Agreement State Report - Under Dose in Brachytherapy Treatment Due to Use of Wrong Length Guide Wire 2013-03-27T05:00:00 | |