ENS 46389

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v t e ENS Event
18:45 Oct 22, 2010
Title	Agreement State Report - Medical Event - Dose Administered in Wrong Location
Event Description	The following report was received from the State of North Carolina via email: The patient has persistent small cell lung cancer after chemotherapy, in an area that has received prior external beam radiation therapy, and was symptomatic. Therefore, a course of endobronchial brachytherapy with a high-dose rate unit (HDR) was recommended to the left upper and left lower lobe bronchus where the tumor was present. The treatment prescription was 10 Gy x 2 fractions to the target volume as defined in the planning CT. The first treatment was delivered between 2 to 3 pm, on Oct 22, 2010. Unfortunately, due to errors in defining the starting dwelling positions of the source during the treatment planning, the actual dose was delivered to the wrong location along the catheters. Details of the process are described below. After two endobronchial catheters were placed under bronchoscopy in the OR [operating room], the patient was transferred to Radiation Oncology Department where a CT was obtained for treatment planning purposes. The two catheters were positioned correctly based on CT. In the first step of the treatment planning, the locations of the two endobronchial catheters were correctly identified in the CT images. The direction of the catheters was mistakenly reversed afterwards during the treatment planning, thereby changing the starting position of the HDR source. Therefore, instead of the patient being treated correctly to the identified tumor region in the left-sided airways, she was treated to a position more proximally along the path of the catheters (the larynx area). Although the plan was checked by a number of qualified physicists per operational protocol, the subtle orientation error was missed, both in the plan check and in the delivery check. The wrong treatment was delivered around 2:45 pm. The error was identified by the planning physicists when they were working on another patient case, about one hour after the patient's treatment. A computerized 3-D plan was generated to calculate the actual location and dose delivered due to this error. The estimated dose to the neck region was about 15-20 Gy. The plan delivered to the patient was also delivered on radiochromic film to confirm the location of the delivered dose. The attending physician, clinical director, and the director of physics were all notified immediately after the error was identified and confirmed. The Radiation Oncology Department chair was notified by the clinical director. The Radiation Safety Officer was notified also by the chief physicist. The attending physician reviewed the case and the dosimetry, and immediately tried to contact the patient. After several attempts the patient was reached around 6:00 PM and asked to come back to the hospital immediately for observation and prophylactic treatments. The patient was admitted to hospital around 9:00 PM on the same day (the time required for her to travel back to Duke from her home). Licensee's evaluation of why the event occurred: a. Staff physicists were more focused on dose optimization and missed the catheter's orientation. B The wrong orientation was again missed during the plan and delivery checks. C. In addition to calculation checks, there was no experimental check, i.e. delivering dose to the film to verify the distance. The effect, if any, on the individual(s) who received the administration: The patient was admitted to Duke Hospital immediately after the error was discovered. She remained hospitalized for 4 days during which time she remained relatively asymptomatic. She did not develop increasing hoarseness, shortness of breath, or odynophagia. She underwent fiber optic laryngoscopy 36 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> after her treatment which showed minor edema of the supraglottic larynx but no airway compromise. She received the correct treatment while an inpatient, and after one additional day of observation was discharged home. What actions, if any, have been taken or are planned to prevent recurrence: a. Conducted a root-cause analysis of the event among the physicists. B. A new and more detailed standard operational procedure (SOP) for this type of treatment was generated by the members of the Brachytherapy team. C. The existent HDR Patient QA form was edited to add extra check levels that will prevent this error from happening again. D. A new verification procedure was added to the existent set of verification procedures. It involves the delivery of the treatment on Gafchromic film or alternative imaging device to verify the exact starting point of the treatment. This film will be compared with the plan and will have to be approved by two physicists and the attending for each case. Certification that the licensee notified the individual (or the individual's responsible relative or guardian) and if not, why not: The patient was contacted, was returned to Duke and was admitted for evaluation and management. Log # NC 10-47 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.

ENS 46389 +/-
Where
Duke University Medical Center Durham, North Carolina (NRC Region 1)
License number:	032-0247-4
Organization:	Nc Div Of Radiation Protection
Reporting

Agreement State
Time - Person (Reporting Time:+282.97 h11.79 days <br />1.684 weeks <br />0.388 months <br />)
Opened:	Henry Barnes 13:43 Nov 3, 2010
NRC Officer:	John Knoke
Last Updated:	Nov 3, 2010
46389 - NRC Website
v • d • e

v t e Emergency Notification System
Duke University Medical Center with Agreement State
WEEKMONTHYEAR2022-12-01T05:00:00 [Table view]
[ENS list for Duke University Medical Center]

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