Event Notification Report for November 04, 2000

LOSS OF POWER TO THE EOF DUE TO PLANNED MAINTENANCE

"LOSS OF POWER TO THE EMERGENCY OPERATIONS FACILITY. THIS IS A PREPLANNED MAINTENANCE ACTIVITY ON BREAKER H2110. THE REMOVAL OF THIS BREAKER CAUSES THE FACILITY (EOF) TO LOSE POWER AND IS, THEREFORE, 'POTENTIALLY' UNAVAILABLE FOR GREATER THAN 90 MINUTES. THE TOTAL ESTIMATED DURATION OF THE ACTIVITY IS 8 HOURS."

THE LICENSEE WILL INFORM THE NRC RESIDENT INSPECTOR.

* * * UPDATE AT 1040EST ON 11/7/00 FROM BRUCE LUTHANEN TO S. SANDIN * * *

The licensee is retracting this report based on the following:

"Event Notification 37487 is hereby retracted, This notification reported the unavailability of the Emergency Operations Facility (EOF) due to an electrical maintenance activity that removed power from the EOF, as required by plant operating procedures.

"The guidance for the one-hour call reporting criteria was obtained from a plant instruction which specifically stated that a one-hour-call to the NRC shall be made 'if, in the judgment of the Control Room Shift Supervisor, equipment failure or extensive maintenance activities have or will render one or more of the Perry onsite ERFs [Emergency Response Facilities] unavailable..'

"10 CFR 50.72(b)(1)(v) requires one-hour, non-emergency notification for 'any event that results in a major loss of emergency assessment capability, offsite response capability, or communications capability (e.g. significant portion of control room indication, Emergency Notification System or offsite notification system.)'

"The EOF electrical maintenance was a planned, scheduled activity. The Alternate Emergency Operations Facility was available during this time to provide redundancy of all required EOF features dealing with emergency assessment and offsite communication. This capacity was never lost or degraded, and so the criteria for reporting were not met. There is no corresponding section under 10 CFR 50.73, and so an LER is not required."

The licensee informed the NRC resident inspector. Notified R3DO(Wright).

TWO PATIENTS GIVEN INCORRECT DELIVERED DOSE

The Radiation Safety Officer from Aultman Hospital, on November 4, 2000, at 1300 hours, notified the Ohio Department of Health, that two patients received brachytherapy doses involving Ir-192 temporary implants in excess of 20% of the prescribed dose. The misadministration were discovered during an internal audit of the licensee's Quality Management Program on November 3, 2000, by the Radiation Safety Officer and Radiation Protection Staff.

One patient received two courses of brachytherapy treatments with Ir-192 temporary implants. On September 18, 2000, the delivered dose was 3330 cGy, while the prescribed dose was 2000 cGy. This represents a delivered dose discrepancy of 67%. On October 9, 2000, the prescribed dose was 2250 cGy, while the delivered dose was 3500 cGy. This represents a delivered dose discrepancy of 56%. The patient also had external beam therapy treatment from a linear accelerator that was not considered in this misadministration.

Another patient received two courses of brachytherapy treatments, with only one brachytherapy treatment qualifying as a misadministration. On August 22, 2000, the delivered dose from Ir-192 was 3500 cGy, while the prescribed dose was 1980 cGy. This represents a delivered dose discrepancy of 78%. The patient also had external beam therapy treatment from a linear accelerator that was not considered in this misadministration.

The primary notification from the licensee indicates that the misadministrations are due to operator error in data entry of the source strength in the treatment computer. The facility has recently acquired a new computer, and the operator mistakenly entered the source strengths into the computer as milligram-Radium equivalent (mg-Ra-eq) strengths instead of units of millicuries.

The licensee does not anticipate any adverse effects to the patients as a result of the additional doses. One patient was notified of the misadministration on November 3, 2000. The other patient will be notified later this week by the radiation oncologist, as the referring physician was not immediately available.

The Licensee shall submit a written report to the Ohio Department of Health, Bureau of Radiation Protection, within 15 days after discovery of the misadministration, as delineated in 10 CFR 35.33(2).

* * * UPDATE AT 1430 EST ON 11/13/00 BY MARK LIGHT TO FANGIE JONES * * *

After review of procedures performed by the hospital, two additional overexposures have been determined to have occurred on October 23, 2000 and October 30, 2000. The hospital notified the Ohio Department of Health, Bureau of Radiation Protection on November 13, 2000 at 0910 EST.

The third patient received one course of brachytherapy treatment with Ir-192 temporary implants. On October 30, 2000, the delivered dose was 3240 cGy, while the prescribed dose was 1890 cGy. This represents a delivered dose discrepancy of 71%. The patient also had external beam therapy treatment from a linear accelerator that was not considered in this misadministration.

The fourth patient received two courses of brachytherapy treatments with Ir-192 temporary implants. On October 23, 2000, the delivered dose was 3150 cGy, while the prescribed dose was 2025 cGy. This represents a delivered dose discrepancy of 56 %. On November 6, 2000, the second prescribed dose was 1400 cGy, which was delivered correctly. The patient also had external beam therapy treatment from a linear accelerator that was not considered in this misadministration.

The notification of the third and fourth patient is pending. The licensee reports that the clinical treatment of all patients has not been affected by the misadministration.

As soon as the licensee's management determined that a reportable event had occurred, the licensee took action to provide additional training to staff involved in brachytherapy procedures. The licensee is reviewing their current Quality Management Program.

The Ohio Department of Health, Bureau of Radiation Protection will conduct an on-site investigation to review the procedures and finding of the licensee's Quality Management review and to confirm the adequacy of corrective actions to prevent reoccurrence.

The R3DO (Bruce Jorgennsen) and the NMSS EO (Wayne Hodges) have been notified.