ENS 52448
ENS Event | |
|---|---|
18:00 Dec 20, 2016 | |
| Title | Agreement State Report - Medical Event Involving Wrong Treatment Site |
| Event Description | The following information was obtained from the state of Maine via facsimile:
On 12/19/2016, patient was scheduled for initial verification and treatment with electrons of a right sided metastatic rib lesion of 5 fractions at 400cGy per fraction. Patient was also to be treated with photons to a spinal lesion. Patient had previously been treated to a right sided rib lesion approximately 11 cm superior to the intended treatment site. Treatment location tattoos were present for each of these sites. Failure to identify the correct treatment tattoo and confusion over the treatment note led to the patient being setup to the previous rib tattoo location and treated. A single fraction of 400 cGy was delivered to the previous treatment site. Following treatment, the physician suspected a setup error. Further review of treatment plan confirmed the error. The licensee has notified the patient. A review of causes of the event and corrective actions was initiated. Maine Event Report ID No.: ME 16-002
The following information was received via fax: On 12/19/2016, a patient initiated treatment to a right sided metastatic rib lesion with 12 MEV electrons. The patient was also treated with photons to a T9 spinal lesion. The patient had previously been treated to a right sided rib lesion approximately 11 cm superior to the intended treatment site and a T2 spinal lesion. Each treatment site was marked with a small tattoo as is common in Radiation Oncology. The treating therapists incorrectly identified and set up the radiation treatment to the wrong rib tattoo. This was the patient's first radiation treatment of this course. Therefore, consistent with Radiation Oncology practice, a documented verification step in which the prescribing physician is present and verifies field setup prior to initiating treatment occurred. The physician also failed to identify that the radiation treatment was setup to the wrong tattoo. A single fraction of the intended 5 fractions of 400cGy was then delivered. Referencing SOM rules, PART X, THERAPEUTIC RADIATION MACHINES, a 'Medical Event' means 'the administration of an external beam radiation therapy dose: (1) Involving the wrong patient, wrong treatment modality, or wrong treatment site; or, .. 'The event is considered to meet the intent of 'wrong treatment site' under the rule and is being reported. An initial notification of the State occurred with 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, as prescribed by the rule. This was followed up the same day with an email containing initial details of the event. This report constitutes the written report requirement under that rule required within 15 days of identification. Why the event occurred: The patient had previously been treated to two sites. The new treatment included two additional sites. Each treatment site is marked with a small tattoo. The appropriate treatment tattoo was misidentified. Patient was set up to the tattoo of the previously treated right sided rib lesion approximately 11 cm superior to the intended treatment site. Treatment setup information was available in the form of simulation photos and graphical treatment plan to adequately identify the appropriate treatment site. Available information was not accessed in the treatment room during set up of the patient. When the plan is brought up on the treatment machine, information is presented on the overhead monitors in the treatment room. This is limited to 3 photos (1 being patient race photo) and 256 characters of text. Prior to treatment, dosimetrists load all available simulation images into the electronic chart only assuring that the face photo is the first for each field. During initial therapist chart review the most informative photos are selected by the therapist to be presented in the room that they will find useful to setup the patient. This did not occur in this case. Two face photos and an ambiguous photo was present. This 1 photo when coupled with the note did not provide clear field setup direction. When a right rib tattoo was readily identified by the therapist they assumed that they were on the correct tattoo and chose to rely on the limited information that was presented on the overhead monitor. Comprehensive setup information was available in the simulation documentation, EMR and the graphical treatment plan available in the electronic medical record (EMR). This information was available on the in room EMR computer. It is understood by the therapist that the overhead monitor may not be able to convey all necessary setup information and routinely refer to the EMR. This physician routinely requests a hard copy print out of the setup of electron treatments so that the image can be compared to surface landmarks. The image print out is not requested by all physicians. A print out was not provided by the dosimetrist. When requested, the therapist did bring up the plan information on the in room EMR computer monitor for reference by the physician. The setup error was also not detected by the physician. Immediately following treatment the physician requested a print out of the patient setup from dosimetry and noted the error. A review of causes of the event and development or corrective actions was initiated. The effect on the patient: Due to the superficial nature of electrons the dose delivered to the wrong site will result in no appreciable impact on skin or underlying healthy tissues. The treatment dose can be made up in the remaining days of scheduled treatment safely providing full therapeutic dose to the target lesion. What improvements are needed to prevent recurrence; actions taken to prevent recurrence? The need to select the most informative images to be presented in the treatment room was added to a newly created comprehensive pre-treatment chart checklist. This step is required to be initialed by both the dosimetrist and therapist performing pre-treatment chart check. The need to select those photos as photo 1 and photo 2 in the EMR was reviewed with the dosimetrists, who were previously unaware of the functionality added approximately 1 year ago. The need to no longer add the face photo to the plan, which is now presented in the room automatically, was also shared. The need to review and configure the in-room field notes and photos, the need to utilize additional information in the EMR if the in-room note is unclear, and the need to reach out to the planning dosimetrist if treatment remains ambiguous was reemphasized with the therapist. The newly installed TrueBeam treatment machines allow electronic reference field images to be easily generated and taken through the field aperture even for clinical patient setups. A comparison of proximal bony anatomy at the treatment site to the reference derived from the planned treatment can performed at the treatment console to assure treatment of the correct location. Initial verification image guidance, common on most photon treatments, will now also be required for electron treatments. The prescription was titled Right 8th rib. The treatment plan was titled Right Inferior Rib. The dosimetrist considered inferior rib to be more descriptive and one more generally understood by staff than 8th rib. Consistency of prescription and plan name is weak potential barrier in this case, but in general consistency will serve to minimize potential for gross errors such as wrong body part and laterality issues. The verification of consistency of prescription and plan names was added to newly created comprehensive pre-treatment chart checklist. As of this date, Maine General has classified this as a Sentinel Event. As such, an independent Root Cause Analysis is planned by our Risk Management Department. That assessment is in progress and as yet no additional corrective actions have been identified. Event and corrective actions will be reviewed in the department Quality Committee. Notification of the patient: Event was reviewed with the patient by the physician on 12/20/16 prior to delivery of the next scheduled treatment. Patient was informed that an error had been made, that impact was negligible to the re-treated site, and that full therapeutic dose could be delivered safely to the intended site. A physician's note is available in the patients chart documenting that conversation. Conclusion: The root cause of the event is determined to be human error. The incorrect one of two right rib tattoos was identified and referenced for treatment setup. Contributing factors included limited in-room information to initially setup patient and failing to access readily available information if setup information was ambiguous. Corrective actions have been put in place to assure than in-room data presented on the overhead monitors ls present and as comprehensive as possible. The need to access additional information using the EMR or other resources when the setup is ambiguous was reemphasized with the staff. An additional barrier created to prevent repetition of the event is the addition of image guidance for all electron treatments during initial treatment verification. A comparison of proximal bony anatomy at the treatment site to the reference derived from the planned treatment can performed at the treatment console to assure treatment of the correct location. Notified the R1DO (Dentel) and NMSS (via e-mail). 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 | |
|---|---|
| Mainegeneral Medical Center Augusta, Maine (NRC Region 1) | |
| License number: | 11623 #30 |
| Organization: | Maine Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+-1.4 h-0.0583 days <br />-0.00833 weeks <br />-0.00192 months <br />) | |
| Opened: | Thomas Hillman 16:36 Dec 20, 2016 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Jan 3, 2017 |
| 52448 - NRC Website | |
Mainegeneral Medical Center with Agreement State | |
WEEKMONTHYEARENS 524482016-12-20T18:00:00020 December 2016 18:00:00
[Table view]Agreement State Agreement State Report - Medical Event Involving Wrong Treatment Site 2016-12-20T18:00:00 | |