ENS 52063
ENS Event | |
|---|---|
04:00 May 19, 2016 | |
| Title | Medical Event - Written Directive Not Followed |
| Event Description | {{#Wiki_filter:The following is excerpted from the report sent via email:
On June 16, 2016 [the licensee's Director of Radiation Safety] was notified by the Authorized User (AU) of an issue regarding the May 19, 2016 radioembolization of a patient. During the subsequent review of the patient's treatment plan in preparation for an additional radioembolization of the Right Hepatic Lobe (scheduled for June 16, 2016) the AU observed the May 19, 2016 Written Directive/treatment plan was completed for the Right Hepatic Lobe, but treatment had been delivered to the Left Hepatic Lobe. Review of the physician notes for the case� reveal the intended primary treatment site, as noted by the Interventional Radiologist (IR) was the Left Hepatic Lobe, however, communication between the IR and AU requested a treatment plan for the Right Hepatic Lobe. On 16 June 2016 the AU confirmed with the IR that the Left Hepatic Lobe was indeed the intended treatment site for the 19 May 2016 procedure. Of note, the 19 May 2016 delivery was not completed as stasis was achieved. The AU and Medical Physicist (MP) recalculated the 19 May 2016 treatment plan based on the administered activity and the treatment volume for the Left Hepatic Lobe. The resultant delivered dose was 119.4% of the prescribed dose. The AU determined there was no harm to the patient. After review of the circumstances relative to the requirements stipulated in 10 CFR 35.3045 Report and Notification of a Medical Event, it does not appear this is a Medical Event and therefore, does not meet the reporting requirements of 10 CFR 35.3045. The dose was delivered to the Left Hepatic Lobe prior to the planned delivery to the Right Hepatic Lobe, i.e. both lobes were intended for treatment at different times; the original Written Directive was reviewed and corrected to account for the delivery to the Left Hepatic Lobe and the resultant dose did not exceed any thresholds specified in 10 CFR 35.3045. Although not believed to be reportable as a Medical Event, this incident may be a violation of 10 CFR 35.40, Written Directives, paragraph (c) and/or 10 CFR 35.41, Procedures for Administrations Requiring a Written Directive, paragraphs (a)(2) and (b)(2). Therefore, I am submitting this report for your review. Actions taken to preclude a recurrence: 1. A Time Out will occur wherein the AU, Medical Physicist and Interventional Radiologist (IR) communicate the specifics of the treatment plan by asking open-ended questions requiring more than a 'yes/no' answer. The Time Out will be documented via signatures from each of the aforementioned team members. 2. After the mapping study, the IR will clearly indicate the preferred treatment site(s) in his notes so the AU is clear as to the development of the treatment plan. These have been incorporated into the Radiation Medicine Sirsphere Policy and each member of the team has been instructed regarding the changes. Additionally, this incident is being tracked through our internal Risk Management system for further review and potential improvements to the program. These actions/reviews have been conducted and implemented prior to the next case, which is scheduled for 30 June 2016. Details of Incident 1. Original Written Directive for Right Hepatic Lobe (19 May 2016) a. Activity prescribed: 25.49 mCi b. Dose to Lobe prescribed: 32.13 Gy c. Activity delivered: 23 .48 mCi d. Dose to Lobe delivered: 29.59 Gy 2. Revised Written Directive for Left Hepatic Lobe (16 June 2016) a. Activity prescribed: 19.67 mCi b. Dose to Lobe prescribed: 43.37 Gy c. Activity delivered: 23.48 mCi d. Dose to Lobe delivered: 51. 77 Gy e. Percent variation of administered activity to that prescribed = 19 .4% 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. }}[[Event description::Description::{{#Regex_clear:The following is excerpted from the report sent via email: On June 16, 2016 [the licensee's Director of Radiation Safety] was notified by the Authorized User (AU) of an issue regarding the May 19, 2016 radioembolization of a patient. During the subsequent review of the patient's treatment plan in preparation for an additional radioembolization of the Right Hepatic Lobe (scheduled for June 16, 2016) the AU observed the May 19, 2016 Written Directive/treatment plan was completed for the Right Hepatic Lobe, but treatment had been delivered to the Left Hepatic Lobe. Review of the physician notes for the case� reveal the intended primary treatment site, as noted by the Interventional Radiologist (IR) was the Left Hepatic Lobe, however, communication between the IR and AU requested a treatment plan for the Right Hepatic Lobe. On 16 June 2016 the AU confirmed with the IR that the Left Hepatic Lobe was indeed the intended treatment site for the 19 May 2016 procedure. Of note, the 19 May 2016 delivery was not completed as stasis was achieved. The AU and Medical Physicist (MP) recalculated the 19 May 2016 treatment plan based on the administered activity and the treatment volume for the Left Hepatic Lobe. The resultant delivered dose was 119.4% of the prescribed dose. The AU determined there was no harm to the patient. After review of the circumstances relative to the requirements stipulated in 10 CFR 35.3045 Report and Notification of a Medical Event, it does not appear this is a Medical Event and therefore, does not meet the reporting requirements of 10 CFR 35.3045. The dose was delivered to the Left Hepatic Lobe prior to the planned delivery to the Right Hepatic Lobe, i.e. both lobes were intended for treatment at different times; the original Written Directive was reviewed and corrected to account for the delivery to the Left Hepatic Lobe and the resultant dose did not exceed any thresholds specified in 10 CFR 35.3045. Although not believed to be reportable as a Medical Event, this incident may be a violation of 10 CFR 35.40, Written Directives, paragraph (c) and/or 10 CFR 35.41, Procedures for Administrations Requiring a Written Directive, paragraphs (a)(2) and (b)(2). Therefore, I am submitting this report for your review. Actions taken to preclude a recurrence: 1. A Time Out will occur wherein the AU, Medical Physicist and Interventional Radiologist (IR) communicate the specifics of the treatment plan by asking open-ended questions requiring more than a 'yes/no' answer. The Time Out will be documented via signatures from each of the aforementioned team members. 2. After the mapping study, the IR will clearly indicate the preferred treatment site(s) in his notes so the AU is clear as to the development of the treatment plan. These have been incorporated into the Radiation Medicine Sirsphere Policy and each member of the team has been instructed regarding the changes. Additionally, this incident is being tracked through our internal Risk Management system for further review and potential improvements to the program. These actions/reviews have been conducted and implemented prior to the next case, which is scheduled for 30 June 2016. Details of Incident 1. Original Written Directive for Right Hepatic Lobe (19 May 2016) a. Activity prescribed: 25.49 mCi b. Dose to Lobe prescribed: 32.13 Gy c. Activity delivered: 23 .48 mCi d. Dose to Lobe delivered: 29.59 Gy 2. Revised Written Directive for Left Hepatic Lobe (16 June 2016) a. Activity prescribed: 19.67 mCi b. Dose to Lobe prescribed: 43.37 Gy c. Activity delivered: 23.48 mCi d. Dose to Lobe delivered: 51. 77 Gy e. Percent variation of administered activity to that prescribed = 19 .4% 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 | |
|---|---|
| Georgetown Hospital Washington, District Of Columbia (NRC Region 1) | |
| License number: | 08-30577-01 |
| Organization: | Georgetown Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+1140.05 h47.502 days <br />6.786 weeks <br />1.562 months <br />) | |
| Opened: | Dr. David Smith 16:03 Jul 5, 2016 |
| NRC Officer: | Bethany Cecere |
| Last Updated: | Jul 5, 2016 |
| 52063 - NRC Website | |
Georgetown Hospital with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 563092023-01-11T18:45:00011 January 2023 18:45:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Patient Underdose ENS 520632016-05-19T04:00:00019 May 2016 04:00:00 10 CFR 35.3045(a)(1) Medical Event - Written Directive Not Followed 2023-01-11T18:45:00 | |