ENS 50785
ENS Event | |
|---|---|
05:00 Jan 15, 2014 | |
| Title | Inert Capsule Administered to Patient During Treatment |
| Event Description | The following was received from the licensee via email:
A 40 year old adult male patient was scheduled to receive 150 mCi of radioactive Iodine 131 as a thyroid cancer therapy. The dose, in pill form, was assayed as prescribed on Wednesday 1/15/14 and was believed to have been [administered to the patient]. On 1/23/14, the patient returned for a whole body scan, [which is] a routine part of the procedure. After scanning the patient, it was noted that there was no activity remaining, which could not be possible under normal circumstances, because Iodine 131 has an 8 day physical half-life. Even with biological excretion occurring, one would expect significant detectable activity 8 days after administration. Two technologists were involved, one assayed the dose and put it back in temporary storage, the other subsequently retrieved the capsule and administered it. Upon investigation it was found that an inert capsule was inadvertently retrieved rather than the patient's capsule. The capsule the patient should have received was discovered and assayed, and found to be the actual capsule that should have been delivered. The tablet given to the patient had an activity of 30 mCi of Iodine 131 on 8/2/13, this was some 20 half-lives prior to the January 2014 date of this incident and [the capsule] was therefore completely inert, therefore no dose was administered. [The licensee] talked with [the licensee's] Nuclear Medicine consultant, to review the regulations. Upon review of USNRC regulations and based upon advice from [the consultant], this was not deemed a medical event but rather a self-identified violation of our procedures. Based upon an NRC review during an inspection on 2/3/15 we were advised that this occurrence, in [the NRC inspector's] opinion, constitutes a Medical Event based on Title 10 of the Code of Federal Regulations Part 35.3045. We were advised to contact the USNRC offices in Region III by the end of business on 2/4/15 and report the occurrence as a Medical Event. With respect to patient impact, papillary/follicular cancers are slowing grow and indolent, and a delay in treatment would not be expected to adversely affect the outcome. The patient was subsequently rescheduled and administered the [prescribed] dose of Iodine 131. In order to determine cause and institute corrective measures, a root cause analysis investigation was conducted and as a result, procedure revisions were implemented to prevent the likelihood of additional errors of this type.
Since the patient received no dose as a result of this procedure, it was determined that this event was not a medical event. Notified R3DO (Stone) and NMSS Events Notification via 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. |
| Where | |
|---|---|
| Iu Health Ball Memorial Hospital Muncie, Indiana (NRC Region 3) | |
| License number: | 13-00951-03 |
| Organization: | Iu Health Ball Memorial Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+9252.38 h385.516 days <br />55.074 weeks <br />12.674 months <br />) | |
| Opened: | Alvis Foster 17:23 Feb 4, 2015 |
| NRC Officer: | Daniel Mills |
| Last Updated: | Feb 26, 2015 |
| 50785 - NRC Website | |
Iu Health Ball Memorial Hospital with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 507852014-01-15T05:00:00015 January 2014 05:00:00
[Table view]10 CFR 35.3045(a)(1) Inert Capsule Administered to Patient During Treatment 2014-01-15T05:00:00 | |