ENS 44733
ENS Event | |
|---|---|
19:00 Dec 17, 2008 | |
| Title | Medical Dose Less Than 50 Percent Of Prescribed Dose |
| Event Description | Suspected movement of catheter during endobronchial high dose rate remote afterloading treatment procedure may have resulted in a single fraction of a multifraction treatment to differ from the prescribed dose by more than 50%. [35.3045(a)(1)(iii)].
The intended dose was 500cGy to the Rt Bronchus (lung). Both the patient and the referring physician were notified by the authorized user of the possibility the intended treatment site did not receive full dose. 1. Patient had endobronchial catheter placed in Rt Bronchus in the endoscopy department. Catheter was taped in place and position was marked. 2. Patient was scanned in CT simulation room by therapist to determine catheter location and treatment dwell positions. 3. Patient treatment plan was created by physicist and approved by the authorized user. Second calculation check was performed. 4. Patient was monitored by nursing during the treatment planning process. 5. Patient was brought into HDR treatment room by therapist. 6. Authorized physicist and authorized user connected the treatment applicator to the HDR unit. 7. Technologist monitored patient on the camera system. 8. Treatment was administered as planned. 9. Patient was disconnected from the HDR unit. 10. Technologist removed catheter post treatment, noted the catheter she pulled out was relatively short compared to the planning scan. 11. Technologist notified the authorized user and authorized physicist. 12. Both individuals notified the RSO. 13. RSO investigated and interviewed individuals involved. 14. AU not sure at what point the catheter moved. Patient may have dislodged catheter when coughing or wiping mouth secretions. Actions to prevent re-occurrence: 1. Authorized user will remove all endobronchial catheters post treatment in the future to prevent any ambiguity with regard to length of catheter in patient. 2. Check marked position of the catheter at CT and both pre and post treatment prior to catheter removal. 3. Measure catheter length outside the naries prior to planning CT, prior to treatment, and post treatment as a second check to the marked position. The Pulmonologist and Authorized user will perform a bronchoscopy in about 2 weeks [to determine if misadministration occurred]. Treatment reactions outside the planned treatment site will be evaluated and determination of treatment in an unintended area will be determined. A Medical Event may indicate potential problems in a medical facilities use of radioactive materials. It does not necessarily result in harm to the patient.
Basis for initial report: Basis for the initial report was the possibility that a medical event may have occurred. It was uncertain whether the endobronchial catheter moved before, during, or after the treatment. The patient's clinical response suggests that the catheter was correctly positioned during the treatment. Evidence supporting appropriate treatment administered: Authorized user (AU) continued to follow the patient closely since administration of treatment on 12/17/08. AU reported on 12/18/08 and 12/24/08 in patient follow-up no clinical evidence exists that would support a mistreatment. The AU reported, the patient was initially admitted with hemoptysis which resolved post treatment. In addition, the AU reported the patient has 'no treatment related toxicity, no pain, no discomfort and is feeling very well.' The AU stated she does not believe there was a medical event and based on the clinical evidence and follow-up there was 'no indication of a misadministration.' Based upon the aforementioned, the AU requests the medical event be retracted. Change in follow-up plan: Patient was discharged to another facility for treatment of an unrelated condition. AU reported based on patient improvement no additional treatment or bronchoscopy was required at this time. Subsequent treatment planned after discharge from other facility in several weeks. Process improvement steps identified and already implemented: 1. All endobronchial catheters will be removed by the AU post treatment. 2. Current procedures will be modified as follows: At the time of insertion the catheter will be securely taped in place. A physical measurement of the catheter length extended beyond the nares/securing tape in reference to an indexing mark on the catheter will be immediately conducted after catheter insertion by the AU and/or AMP, verified by the non-measuring party and recorded in the patient record. In accordance with standard operating procedure the catheter will continue to be marked with a permanent marker for visual check and recorded. These measurements will be rechecked and recorded prior to CT imaging for planning, just prior to treatment and post treatment. Significant deviations in measurement will be reported to the AU and will require re-imaging to verify catheter placement pre-treatment. Notified the R1DO (Dentel) and FSME (Bubar). |
| Where | |
|---|---|
| Trinitas Hospital Elizabeth, New Jersey (NRC Region 1) | |
| License number: | 29-04333-01 |
| Organization: | Trinitas Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+22.68 h0.945 days <br />0.135 weeks <br />0.0311 months <br />) | |
| Opened: | Linda Veldkamp 17:41 Dec 18, 2008 |
| NRC Officer: | Mark Abramovitz |
| Last Updated: | Dec 31, 2008 |
| 44733 - NRC Website | |
Trinitas Hospital with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 447332008-12-17T19:00:00017 December 2008 19:00:00
[Table view]10 CFR 35.3045(a)(1) Medical Dose Less than 50 Percent of Prescribed Dose 2008-12-17T19:00:00 | |