The State of
Florida was notified on 01/11/07 by
Florida Agency for Health Care Administration that while performing an audit of the licensee it appeared a misadministration of
brachytherapy seeds on June 13, 2006 was not reported to DOH-BRC, nor was there any documentation it was done. The State is planning to visit the licensee in the next few days to obtain details of this medical event from the Radiation Oncologist.
The auditor provide the following documentation to the State concerning a prostate seed implant procedure performed on June 13, 2006 at the Surgical Center of Central Florida:
A review of preplanning, live planning and post planning documents was conducted on June 22, 2006, and a wrong site administration (as defined in Florida Administrative Code 64&5. 101, 88-6) was declared by the prescribing radiation oncologist and the Radiation Safety Officer associated with the Cancer Care Center of Sebring. Their conclusion was supported by diagnostic films and the physics calculations. Consistent with the Florida Radiation Safety Guidelines, the patient's referring physician was also contacted by the treating urologist on June 23, 2006 and [the] facility was advised within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the finding. Both the patient and his wife have been informed of the post procedure evaluation results and the patient has undergone a diagnostic computed tomography exam and follow-up appointment at the Cancer Care Center in Sebring.
As a result of further assessment, the apparent misadministration incident was determined to be reportable to the State of Florida pursuant to Florida Administrative Code Section 53E-5.345 4A by the license holder and its' Radiation Safety Officer. . . .
The procedure involved the implant of sixty I-125 seeds totaling approximately 20 milliCuries.
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.