Event Notification Report for April 20, 2000

AGREEMENT STATE REPORT: MEDICAL MISADMINISTRATION -

At 1300 on 04/20/00, a 52 year old female patient received a medical misadministration of a gamma knife treatment at the University of Maryland at Baltimore (UMAB) Hospital to reduce the cancerous tumor in her head.

The gamma knife is a UMAB specific license that uses 201 sealed Cobalt-60 sources of 30 curies each in a Model 23016 Leksell Gamma System for the radiation treatment of human patients.

The patient received 12.6 gray to an unintended site of approximately 0.18 cubic centimeters. The unintended site was approximately 4.2 centimeters from the intended site.

The medical directive for this treatment was defined as approximately 18 gray administered over six administrations. The misadministration occurred during the first administration only. The treatment planning for the patient was uneventful and was prepared and reviewed by a hospital gamma knife team of a Radiation Oncologist, a Neurosurgeon and a Medical Physicist. It appears from preliminary interviews that when two of the team members were adjusting the coordinates on the device's steriotactic frame, the Y and Z coordinates were reversed. This frame adjustment is accomplished by loosening the frame via the use of allen screws and manually adjusting it. One person calls out the coordinate and the other conducts the adjustment. According to the licensee procedures, this adjustment is to be checked for accuracy by a nurse and the Medical Physicist. Normally the coordinates are read out in a specific order. The licensee indicated that the order might have been reversed due to a specific frame orientation problem that occurs approximately once in every 20 treatments. When the licensee started to set up for the second administration, the error was noted. The treatment plan was reevaluated to include some partial dose to the tumor from the first administration and the treatment was completed in seven administrations instead of six.

The patient and her referring physician have been notified of this misadministration. This misadministration constitutes no negative medical impact on the patient.

A MD DOE representative requested that UMAB Hospital personnel review previous medical files to assure that this switching of coordinates has not happened before without a misadministration being identified.

The gamma knife is not scheduled to be used again at UMAB Hospital until 04/25/00. On 04/24/00, a hospital management meeting has been scheduled among personnel from Hospital Administration, Oncology, Neurosurgery and the Radiation Safety Office to discuss this incident. The RSO's position at this meeting will be that all use of the gamma knife be suspended until the incident has been fully investigated and assurances are in place to prevent recurrence.

A written report of this incident will be submitted to NMED within 30 days.

- LICENSEE NOTIFIED NATIONAL RESPONSE CENTER AND STATE DEP OF A CHEMICAL SPILL ONSITE -

The licensee notified the National Response Center and the State Department of Environmental Protection (DEP) that approximately 5 gallons of a mixture of sulfuric acid and sodium hydroxide spilled from a tank truck onto the ground after a chemical reaction took place. The spill was contained within a portable dike area onsite and is being cleaned up.

The licensee plans to notify the NRC Resident Inspector.

* * * UPDATE AT 0948 EDT ON 04/26/00 FROM ROY HARDING TO S. SANDIN * * *

The licensee is retracting this report based on the following:

"This is a retraction of the notification made on 04/20/00 at 2029 hours (Event 36911). This event was reported as a notification of another government agency [National Response Center and Pennsylvania Department of Environmental Protection (PADEP)] pursuant to 10CFR50.72(2)(b)(vi).

"On April 20, 2000 at 1930 hours while Limerick Unit 1 was shutdown for refueling, 5 to 10 gallons of a dilute and partially neutralized acid (Sulfuric Acid-pH 3) was expelled from a temporary trailer tank onto asphalt and stone surface in an adjacent area outside a temporary dike. In addition, approximately 30 gallons of the acid/sludge mixture spilled into the temporary dike. The spill never threatened navigable waterways, and subsequently was cleaned up within a 24 hour period. The initial notification was conservatively reported based on information known at the time of the event.

"A minor spill of this nature is not reportable to the PADEP in accordance with 40CFR112 and the Preparedness Prevention Plan for Limerick Generating Station. This spill from a temporary tank had no impact on navigable waterways and was less than the Reportable Quantity (69 gallons)."

The licensee will inform the NRC Resident Inspector. The NRC Operations Officer notified the R1DO (Noggle).

POSSIBLE OVEREXPOSURE

On 04/20/00 the Radiation Safety Officer for ABI Laboratory, Inc., received a phone call from Troxler informing her that one of the film badges that they had read had a reading of 30,677 mrem (30.7 Rads). Troxler will check the film badge again on Monday, 04/24/00, since Friday is a holiday. The film badge belongs to an ABI Laboratory, Inc., employee who is currently working at a construction site located at the Philadelphia International Airport . The film badges for ABI Laboratory, Inc., are checked quarterly by Troxler. The film badge mentioned above had been used during the December 1999 through February 2000 time period.

The ABI Laboratory, Inc. construction site has 2 Troxler and 2 Humboldt Density Gauges. The Density Gauges were all leak tested and radiation surveys were taken inside and around the building containing the gauges. All radiation surveys and leak tests were within expected values.

From December 1999 through February 2000, the employee in question used a Density Gauge on 20 different days.

PROJECTED DOSES TO A PATIENT MAY BE OFF BY GREATER THAN 20 PERCENT

ST. JAMES HOSPITAL CALLED THE ILLINOIS DEPARTMENT OF NUCLEAR SAFETY TO REPORT A MEDICAL THERAPY EVENT. FOUR IRIDIUM-192 SEEDS (APPROX. 5mCi each) WERE INSERTED THROUGH A PATIENTS NOSE TO TREAT THE BILE DUCT ON TUESDAY. THE PHYSICIAN HAD MARKED THE TUBE AT THE NOSE AS A REFERENCE POINT. ON THURSDAY THE PHYSICIAN NOTICED THAT THE REFERENCE POINT HAD MOVED. ST. JAMES HOSPITAL PERFORMED AN X-RAY AND NOTICED THAT THE SOURCES WERE NO LONGER AT THE TREATMENT SITE. THE LICENSEE BELIEVES THAT THE DOSE TO THE INTENDED AREA WILL BE OUTSIDE THE RANGE OF THE 20% LIMIT. THE LICENSEE BELIEVES THE TREATMENT WENT AS PLANNED FOR THE FIRST 24 HOURS AND THAT THE SEEDS MOVED SOMETIME DURING THE SECOND 24 HOURS. TOTAL TREATMENT TIME WAS SUPPOSED TO HAVE BEEN 70 HOURS.

THE LICENSEE IS PERFORMING A DOSE ASSESSMENT NOW AND WILL FORWARD A WRITTEN REPORT TO THE ILLINOIS DEPARTMENT OF NUCLEAR SAFETY WITHIN 15 DAYS. THE LICENSEE PLANS TO CONTINUE THE TREATMENT ONCE THEY HAVE A BETTER ESTIMATE OF DOSES TO THE TREATMENT SITE.

MEDICAL MISADMINISTRATION

Unintended deviation from a written directive in the use of an investigational temporary brachytherapy implantation device on 04/20/00. Device is the Proxima Therapeutics, GliaSite RTS (a 2-4 cm balloon catheter). The device is being investigated under the NABTT # 9801 Multi-center open label clinical study to evaluate the performance of the Proxima GliaSite RTS in patients with recurrent brain tumors undergoing surgical resection.

In this study, the GliaSite RTS is implanted in the tumor resection bed at the time of surgery. Two weeks following surgery, a solution of lotrex and saline is infused into he balloon catheter in order to deliver the radiation dose. Following a specified dwell time, the lotrex is removed from the balloon and the balloon is then surgically removed from the patient's brain. Prior to therapy, radiographic contrast media is infused into the balloon to verify the balloon placement. This contrast media is removed just prior to the infusion to the lotrex. All fluid volumes are tracked to determine the exact volume of fluid in the balloon at all times.

In the specific treatment plan where the deviation from the written directive occurred, was prescribed by a Radiation Oncologist and infused into a balloon by a Nuclear Medicine Physician with a dwell time of 70 hours.

Following the prescribed dwell time the lotrex was removed and an initial assay of the retrieved lotrex demonstrated a 60% apparent reduction in retrieved activity as compared to the administered activity. The reduced activity measured in the retrieval fluid was to be due to a mixture of contrast media with the lotrex in the fluid. By diluting the retrieved fluid, to remove attenuation characteristics of the contrast media, the total administered activity was measured.

Since the contrast media was causing attenuation of the radioactivity in the retrieved fluid, resulting in a reduction of the Dose Calibrator readings, it is assumed the radiation dose to the tissue surrounding the balloon was also reduced. The absorbed dose to the tissue cannot be determined accurately due to the uncertainty in the homogeneity of the iodine-125 and contrast media in the GliaSite RTS during the therapy. Therefore, the attenuation characteristics and absorbed energy within the tissue cannot be accurately modeled.

During the investigation of this incident, all steps contained within the Henry Ford Hospital and NABTT #9801 Quality Management Programs were followed. This incident notification of the patient, physicians and all attending staff within 4 hours following the retrieval of the lotrex that an apparent discrepancy in the activity retrieved existed. In addition, all trash and urine were verified to have been retrained and surveys of these waste showed negligible readings. All room surveys also showed no contamination. The patient, as well as fluid retrained from the surgical site and the GliaSite RTS all demonstrated no contamination. The patient was not harmed by the event.

To prevent contrast contamination during this therapy in the future an additional flushing of all fluid from the balloon prior to infusion of the lotrex will be done.

The NABTT #9801 study is intended as a Phase 1 device trail rather than a clinical efficacy trail.

- HPSI, LPSI & CS SYSTEMS OUTSIDE THEIR DESIGN BASIS DUE TO LACK OF INSTALLED INSULATION -

The following is the text of a fax received from San Onofre:

This notification from San Onofre Units 2 and 3 is being made in accordance with 10CFR50.72(b)(1)(ii)(B) for the condition of the High Pressure Safety Injection (HPSI), Low Pressure Safety Injection (LPSI) and Containment Spray (CS) Systems being outside their design basis. This condition exists for both Units 2 and 3.

On 04/19/00, during an NRC inspection, it was discovered that portions of the ECCS piping were not insulated as assumed in design calculations. Affected lines are the suction and discharge piping for the HPSI Pumps #P017, P018 & P019, LPSI Pumps #P015 & P016, and CS Pumps #P013 & P014. The consequence of the missing insulation is that the heat loads in the ECCS pump rooms will be higher than assumed in the plant accident analyses.

At 0745 PDT on 04/20/00, SCE concluded that ECCS pump room temperatures during certain accident scenarios may not remain below their design basis room temperatures of 104°F. However, the equipment in the pump rooms continues to be operable at the calculated higher post-accident temperatures. That is, even with the higher than expected ECCS pump room temperatures, the affected equipment would continue to be able to perform its intended safety function.

SCE has installed some temporary insulation and will take actions to install permanent insulation on the affected piping. SCE's investigation of this occurrence is ongoing; the cause of this condition will be reported in the followup 30 day licensee event report.

At the time of this discovery, both Units 2 and 3 were operating at about 100% power: Unit 1 remains permanently defueled. SCE plans to notify the NRC Resident Inspectors about this issue and will provide them with a copy of this event report.

- UNIT 2 S/Gs PRIMARY-TO-SECONDARY DESIGN DIFFERENTIAL PRESSURE OUTSIDE DESIGN BASIS -

Indian Point Unit 2 received a letter from Westinghouse (the NSSS Supplier) which stated that Westinghouse is in the process of completing a Nuclear Safety Advisory Letter regarding the primary-to-secondary design pressure differential in the steam generators. The current design pressure listed in the equipment Specification is 1550 psid. With an anticipated steam generator outlet pressure in the 650 to 660 psia range, this design pressure will be exceeded. However, Indian Point Unit 2 has an analysis that determined that the limiting structure within the steam generator, the tube sheet, can withstand a pressure differential of 1750 psid. This issue may be addressed by updating the design pressure and stress reports demonstrating compliance with the ASME Code as governed by Section IWA-4312, Re-rating, of Section Xl of the ASME Code.

The licensee plans to notify the NRC Resident Inspector.