ENS 48298
ENS Event | |
|---|---|
04:00 Aug 28, 2012 | |
| Title | Agreement State Report - Patient Received Two Underdoses of Y-90 to Different Treatment Sites |
| Event Description | The following information was received from the State of Rhode Island via fax:
Event Type: Medical event involving the administration of Yttrium-90 microspheres. Notification(s): On August 30, 2012, the RI Department of Health Office of Facilities Regulation, Radiation Control Program received a phone call from the facility's Radiation Safety Officer, with a follow-up e-mail the same day. Event Description: On 08/28/2012, two incorrect doses were prepared for a Y-90 microsphere treatment. Both doses were for the same patient (i.e., two different treatment sites). One dose was drawn at 28.7% less than prescribed and the other dose was drawn at 22.9% less than prescribed. The final administered doses were less than 40.3% and 27.2% prescribed, respectively. Cause of the event: Under investigation and unknown at this time. Actions: Adverse effects to the patient are not expected; a follow-up reactive inspection is planned. [Rhode Island] Event Report ID: 2012-001
The State of Rhode Island provided the following information via fax: Cause of the event: For both doses, after withdrawing the microspheres from the shipping container, the licensee nuclear medicine technologist added sterile water to the syringe prior to transferring them into the v-vial. The policy is that the Y-90 is transferred into the v-vial prior to adding sterile water. The technologist then added additional sterile water to the v-vials in accordance with procedure. For both doses, after placing the v-vial into the dose calibrator, the technologist noticed that the dose was less than the 10% prescribed by the physician. The technologist was confused about the correction factor of 0.82 required for the v-vial when placed into the dose calibrator. The technologist did not understand why the original dose drawn from the shipping vial was within +/- 10%, but the v-vial dose was not. The technologist ultimately concluded that the shipping v-vial should have also been corrected by 0.82 and sent the dose to Interventional Radiology (IR) where it was administered. Although the dose withdrawn from the shipping container was originally within +/- 10%, some of the microspheres were most likely lost during transfer to the v-vial. The most likely cause was due to adding sterile water, prior to transfer. The doses drawn by the Nuclear Medicine Technologist were 9.84 mCi for the right lobe (Vial 1) and 10.41 mCi for segment VII, neither of which are within the +/- 10% established by policy. After administration of both doses, the v-vials were sent back to Nuclear Medicine per procedure and assayed in the dose calibrator for residual activity. The dose to the right lobe (Vial 1) and the dose to segment VII (Vial 2) had 1.6 mCi and 0.57 mCi remaining, respectively. Therefore, not all of the microspheres were administered. As a result, the final administered dose to the right lobe was 8.24 mCi and the dose to Segment VII was 9.84 mCi. This resulted in an under administered dose of 40.3% to the right lobe and an under administered dose of 27.2% to segment VII. Licensee Actions: As a result of this event, the RSO performed an in-service training [that] was held on 9/21/12. The licensee also does an additional 'timeout' when the dose is brought to the IR suite to verify prescribed versus drawn dose. The Nuclear Medicine staff alternate drawing the Y-90 doses to maintain familiarity with the procedure. RI RCP [Rhode Island Radiation Control Program] Actions: The corrective actions outlined by the licensee have been complete therefore, no further action is required at this time. Notified R1DO (Caruso) and FSME Events Resource (email). 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.
The following information was received via fax: Per the physician, this misadministration, which was lower than the planned dose based on body surface area, will not result in any harm to the patient. Repeat administration was already anticipated, if there was evidence for a response. The Bremsstrahlung scan shows increased activity in the tumor bed as well, consistent with an adequate delivery to the target. As a result of this event, the RSO will perform an in-service training on the Y-90 SirSphere Worksheet which will include practice runs so staff are comfortable with the math involved (specifically the correction factor of 0.82). The RSO has requested and the Director of Diagnostic Imaging has agreed that the Nuclear Medicine technologists shall rotate frequently on performing Y-90 microsphere dose preparations. Additionally, once the dose is brought to IR there will be an additional timeout to verify that the prepared dose by Nuclear Medicine matches that of the WD [written directive]. [The physician] notified that patient via telephone on August 30, 2012. Notified the R1DO (Rogge) and FSME Event Resources (via e-mail).. |
| Where | |
|---|---|
| Roger Williams Medical Center Providence, Rhode Island (NRC Region 1) | |
| License number: | 7D-026-01 |
| Organization: | Ri Dept Of Radiological Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+345.12 h14.38 days <br />2.054 weeks <br />0.473 months <br />) | |
| Opened: | Charma Waring 13:07 Sep 11, 2012 |
| NRC Officer: | Steve Sandin |
| Last Updated: | May 30, 2014 |
| 48298 - NRC Website | |
Roger Williams Medical Center with Agreement State | |
WEEKMONTHYEARENS 482982012-08-28T04:00:00028 August 2012 04:00:00
[Table view]Agreement State Agreement State Report - Patient Received Two Underdoses of Y-90 to Different Treatment Sites 2012-08-28T04:00:00 | |