Event Notification Report for March 20, 2012

AGREEMENT STATE REPORT - UNDERDOSE DURING LIVER DISEASE TREATMENT

"Event type: A medical event (ME) involving the administration of Yittrium-90 SIR-Spheres which is reportable under 10 CFR 35.3045(a)(1)(i).

"Notifications: On March 21,2012, the Department's [Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection] Southeast Regional Office received notification via a phone call about this ME.

"Event Description: The patient was being treated for disease of the liver and received 77% of the intended dose.

"CAUSE OF THE EVENT: Currently under investigation and unknown at this time.

"ACTIONS: No harm to the patient is expected. The treating physician notified the patient.

"The Department [Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection] plans to do a reactive inspection."

PA Event Report ID: PA120009.

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.

* * * RETRACTION FROM JOSEPH MELNIC TO VINCE KLCO ON 3/26/12 AT 0937 EDT VIA FAX * * *

"Notifications: On March 21, 2012, the Department's Southeast Regional Office received notification via a phone call about this ME. After the HOO notification was made the Department was informed that the measurement for actual dose delivered was repeated two times, both indicating the administration was within acceptable limits.

"Event Description: The patient was being treated for disease of the liver and was initially thought to have received 77% of the intended dose, however after additional measurements were made the dosage delivered was determined to be 81.2% and 82.2%.

"ACTIONS: Medical Event is being retracted."

Notified the R1DO (Newport) and FSME EO (McIntosh).

INCORRECT PATIENT ADMINISTERED NUCLEAR STRESS TEST

"This will serve as the incident report on a patient who inadvertently received an injection of technetium 99m in the Middletown office of Middlesex Cardiology Associates. [The gentleman] is a 68-year-old patient. He has underlying dementia and, at times, poor understanding of his medical care. He arrived at the office over 30 minutes late for his appointment. He identified himself to the front office staff [by his first name]. Because of HlPPA laws, the front office staff did not announce his full name. It turns out that a separate patient, [with the same first name] was scheduled for a 12:30 PM nuclear stress test. [The patient] was brought to the nuclear cardiology imaging department which is separate from the usual patient waiting room. He was told that he was going to have a pharmacologic stress test performed. Before the medical assistant could ask his date of birth, the patient indicated to the nuclear staff that he had had coffee earlier in the day which raised some confusion as to whether he could undergo pharmacologic stress testing. [The patient] never indicated that he was simply there for an office visit. He was subsequently told that he could only have resting imaging performed and would have to return on a separate day for the pharmacologic stress test. He agreed. He had undergone previous nuclear testing and therefore did not protest having an injection of technetium performed. He subsequently received 32.8 mCi of technetium 99 sestamibi. At that point, the correct nuclear stress test patient, checked in with the front office staff. Immediately, it became evident that there were 2 gentleman [with the same first name] scheduled for separate visits on 3/20/12. License photo identification was then performed. It was then discovered that [the first patient] had inadvertently received the technetium injection inappropriately. Given the fact that this dose of technetium would only produce a total body dose of 0.55 rads or approximately 5.3 mGy, there was not felt to be any concern for long-term medical sequelae.

"The patient's physician had a discussion with the patient and subsequently called his daughter to discuss the incident. A detailed letter was also sent to the patient's primary care physician.

"Based on NRC regulations, I contacted the [NRC] Operations Center at 1:25 PM on 3/20/12. I spoke to [the Headquarters Operations Officer] to explain the situation. This afternoon, we had a meeting with all front office staff and nuclear staff to review the importance of patient identification so that this type of incident will never occur again. Patients for nuclear testing will be identified by first and last names as well as birthdates to eliminate confusion."

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.


* * * RETRACTION FROM JOSEPH CORNING TO DONALD NORWOOD AT 1249 EDT ON 3/27/2012 * * *

The total body dose received from the injection of techntium 99 was not high enough to warrant reporting this as a medical event. This event is therefore being retracted.

Notified R1DO (Newport) and FSME (McIntosh).