ENS 50584
ENS Event | |
|---|---|
14:00 Oct 30, 2014 | |
| Title | Patient Received Dose Greater than Prescribed Dose |
| Event Description | This is a notification of a medical event that occurred on October 30, 2014 at 1000 EDT in which the Y-90 SIR-Sphere dose delivered to the patient's posterior portion of the right lobe of the liver was more than the prescribed dose by 20 percent or more (10 CFR 35.3045). This patient had a dual administration, with the correct dose administered in accordance with the written directive to the anterior portion of the right lobe of the liver (0.43 GBq and 53.4 Gy). The medical event occurred before this, when the patient who was prescribed a dose of 0.39 GBq (64.5 Gy) was administered a dose that was 20.5% more than the prescribed dose. The posterior portion of the right lobe of the liver was administered 0.47 GBq (77.5 Gy), which was the intended dose for the anterior portion of the right lobe of the liver. The total dose to the right lobe of the liver (both posterior and anterior portions) was 0.90 GBq (142 Gy) compared to the planned dose of 0.91 GBq (143.6 Gy). Our color coding procedure failed to prevent this error. The radiopharmacy staff had applied the green colored dot to the QMP [Quality Management Program] and Dose Planning Forms appropriate for the posterior portion of the right lobe. The medical physicist applied the green colored dot to the checklist intended for the anterior portion of the right lobe rather than to the checklist intended for the posterior portion of the right lobe. The error was not caught during the time out prior to the dose administration. Upon completion of the first of the dual administrations, the medical physicist identified and reported the error to the authorized user and RSO. A time out was called and the decision was made to prepare a new Y-90 SIR-Sphere dosage for the anterior portion of the right lobe in accordance with the written directive. The correct dose was then administered in accordance with the written directive to the anterior portion of the right lobe of the liver (0.43 GBq and 53.4 Gy).
To prevent this from occurring, the color coding procedure was revised by the Radiopharmacy and modeled after their blood labeling process. The check list was revised to instruct the medical physicist that 'If dual administration case, verify correct color dots on QMP form, dose plan, and checklist.' Before a dual administration case is started, the dose planning page with the correct corresponding color dot will be pulled from the paperwork and placed in the control room. This allows the AU [authorized user], physicist, and remaining team (techs, nurses) to see the plan clearly. Once the physician (AU) gains access to the first treatment site, they will give the verbal notice to the physicist, so they can assemble the corresponding dose. With the finished assembly in place table side, the AU and physicist will verify the dose intended for the location. As it pertains to this case, the physician would say, 'We are in the posterior right lobe, the dosage is 0.52 GBq and is labeled with the orange dot, correct?' The QMP was revised to include these revised procedures. No adverse effect is expected for the patient. Both the patient and the referring physician were notified on October 30, 2014. 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 | |
|---|---|
| Beaumont Hospital Royal Oak Royal Oak, Michigan (NRC Region 3) | |
| License number: | 21-01333-01 |
| Organization: | Beaumont Health System |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+4.28 h0.178 days <br />0.0255 weeks <br />0.00586 months <br />) | |
| Opened: | Cheryl Schultz 18:17 Oct 30, 2014 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Oct 30, 2014 |
| 50584 - NRC Website | |
Beaumont Hospital Royal Oak with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 505842014-10-30T14:00:00030 October 2014 14:00:00
[Table view]10 CFR 35.3045(a)(1) Patient Received Dose Greater than Prescribed Dose 2014-10-30T14:00:00 | |