Event Notification Report for September 07, 2005

PART 21 REPORT ON FLUKE RADIATION METER

The following information was received via facsimile:

1.0 Name and address of individual informing the Commission:

Zisimos Giatis
Quality Assurance Manager
Fluke Biomedical Radiation Management Services
6045 Cochran Road
Solon, Ohio 44139

2.0 Identification of the Basic Component supplied which fails to comply or contains a defect:

Customer Complaint 0065 identifies the inability of the customer to insert the detector into the sample volume to the depth defined in primary isotopic calibration report 958.350. The report and manual for the device state the detector is to be inserted to a depth that results in 0.125 inches of the detector body extending outside of the detector mounting flanges. This dimension was expanded to 0.25 inches for the detectors supplied with a removable rear end cap. The customer advised that when installing the detector per the above, the face of the detector would "bottom out" against the sample volume cap before being fully inserted, leaving a gap of approximately 0.3 inches in front of the detector mounting flanges.

3.0 Identification of the firm supplying the Basic Component which fails to comply or contains a defect:

Fluke Biomedical Radiation Management Services
6045 Cochran Road
Solon, Ohio 44139

(Formerly Victoreen, Inc.)

4.0 Nature of the defect or failure to comply and the Safety Hazard created:

Because the insertion depth is a critical component of the sample volume, and thus the efficiency of the detector, the detector CPM to µCi/cc conversion constant cannot be validated. The conversion constant supplied for the sample geometry will result in the detector either overstating or understating the radioactivity being monitored.

5.0 The date on which the information of such defect or failure to comply was obtained:

The problem was discovered September 7, 2005.

6.0 Affective Facilities

Diablo Canyon Nuclear Plant, California
Jose Cabrera, Spain
KEPCO, Republic of Korea
KAERI, Republic of Korea
Con Ed, Indian Point 2

7.0 Corrective Action:

The primary calibration will be repeated and a revised insertion depth will be provided to the affected customers. The estimated time frame to complete this task is 6 months.

8.0 Advice related to the defect or failure to comply about the Basic Component that has been, is being, or will be given to purchasers:

At the Diablo Canyon plant, the accident range gas channel is not required for plant operation, and has been declared inoperable. International customers are being advised that the response of their accident range gas monitors may be questionable and to verify the insertion depth used in their plant.

* * * UPDATE ON 9/23/05 @ 14:00 BY FAX FROM FLUKE BIOMEDICAL TO ABRAMOVITZ * * *

"Entergy (Con Ed) Indian Point 2 will be notified of the situation, although their sampler is no longer being used."

Notified the R1DO (Henderson), NMSS (Moore) and Part 21 (Tabatabai).

FIVE MEDICAL EVENTS WERE DISCOVERED TO HAVE OCCURRED AT ST.VINCENT HOSPITAL IN INDIANAPOLIS, IN

The five events occurred between 3 patients and are explained in the following write-up.

"Events 'A', 'B', and 'C' involve the same patient who received three high dose rate (HDR) brachytherapy administrations on three different occasions with a GYN cylinder application. The dates of treatment occurred on December 19, and 26, 2002 and January 2, 2003. In this case, a 70 year old female, was treated with a Nucletron High Dose Rate (HDR) brachytherapy remote aflerloader unit for endometrial cancer. The physician Authorized User (AU) prescribed a dose of 500 cGy at 0.5 cm from the surface of a 3.0 cm diameter vaginal cylinder for an active length of 6.0 cm using a 8.01, 7.506 and 7.030 Ci iridium-192 source on the three dates of treatment. The treatment plan called for 25 indexer step positions at 2.5 mm spacing. The medical physicist entered 25 indexer step positions at 5.0mm spacing rather than 2.5mm spacing and treatment was delivered.

"A simulated plan was calculated on August 23, 2005, to reproduce the initial treatment plan and actual treatment delivered. The simulation reveals that the patient may have received as much as 360 cGy to an unintended delivery site with each of the three fractions, for a total of 1,080 cGy for the entire course of treatment. The simulation further indicates that the intended treatment site may have received as much as 28% under dosage during the same treatment period. A thorough review of the patients chart indicates that the patient reported having had some "excoriation" of the unintended site initially following treatment but this area had healed prior to a follow up exam on February 6, 2003.

"This patient was last seen by her radiation oncologist January 3, 2004, with no evidence of clinical complications or abnormalities.

"As a result of this review and discovery, St. Vincent Hospital will notify the referring physician and the patient of this event. No further clinical complications are anticipated or expected.


"Event 'D' occurred on December 18, 2002, involved an HDR brachytherapy which also involved a GYN cylinder application.

"In this case, a 56 year old female, was treated with Nucletron High Dose Rate (HDR) brachytherapy remote after loader for cervical. Cancer. The physician Authorized User (AU) prescribed a dose of 500 cGy at 0.5 cm from the surface of a 2.50 cm diameter vaginal cylinder for an active length of4.0 cm. using a 8.089 Ci iridium-1.92 source. The treatment plan called for 17 indexer step positions at 2.5mm spacing. Although the first two fractions were delivered in accordance with the written directive without incident (November 19 and November 26, 2002), for the third and final fraction (December 18, 2002) the medical physicist entered 17 indexer stop positions with 10.0 mm spacing rather than 2.5 mm spacing and treatment was delivered.

"A simulated plan was calculated on August 23, 2005, to reproduce the initial treatment plan and actual treatment delivered. The simulation suggests the patient may have received as much as 200cGy to an unintended site and as much as 60% under dosage to the intended site during delivery of the final fraction. For the entire course of treatment, the calculated dosage through simulation indicates that 1200 cGy rather than 1500 cGy was delivered to the intended site. This represents a twenty percent (20%) under dosage for the overall treatment. A thorough review of the patient chart indicates no abnormal findings during follow up clinical exams and our Radiation Oncology Physicians verify these treatment parameters are within acceptable therapeutic and clinical dosages.

"This patient is currently in active follow-up with her radiation oncologist. This patient was last seen May 5th, 2005 with no evidence of complications or clinical abnormalities. As a result of this review and discovery, St. Vincent Hospital will notify the referring physician and the patient of this event. No further clinical, complications are anticipated or expected.

"Event 'E' occurred on August 7, 2003, involved an HDR brachytherapy which also involved a GYN cylinder application.

"In this case, an 85 year old female, was treated with Nucletron High Dose Rate (HDR) brachytherapy remote after loader for cervical cancer. The physician Authorized User (AU) prescribed a dose of 500 cGy at 0.5 cm from the surface of a 2.00 cm diameter vaginal cylinder. For an active length of 6.0 cm using a 4.74 Ci iridium-1.92 source. The treatment plan called for 13 indexer step positions at 5.Omm spacing. In the delivery of the first fraction, on August 7, 2003, the medical physicist entered 13 indexer step positions with 2.5mm spacing rather than 5.0mm spacing and treatment was delivered. The delivery of the second and third fractions, August 21 and September 4, 2003, the written directive was followed accurately and treatment occurred without incident.

"A simulated plan was calculated on August 23, 2005, to reproduce the initial treatment plan and actual treatment delivered. The simulation suggests that for the initial treatment fraction, the patient may have received as much as 60% over dosage to the proximal portion of the intended site and as much as 44% under dosage to the distal portion of the intended site. The calculated dosage through simulation indicates that 800 cGy was delivered to the proximal portion of the intended treatment site and approximately 280 cGy was delivered to the distal portion of the intended treatment site.

"In accordance with the written directive, the intended site was to receive a dosage of 500 cGy for three fractions for a total of 1500 cGy throughout the course of treatment. The calculated simulation reveals the proximal site received 1800 cGy (20% over dosage) and the distal site received 1280 cGy (15% under dosage) over the course of the three treatments. A. thorough review of the patient chart indicates no abnormal findings during follow up clinical exams and our Radiation. Oncology Physicians verify these treatment parameters are within acceptable therapeutic and clinical dosages.

"This patient is currently in active follow-up with her radiation oncologist. This patient was last seen August 15, 2005 with no evidence of complications or clinical abnormalities.

"As a result of this review and discovery, St. Vincent Hospital will notify the referring physician and the patient of this event. No further clinical complications are anticipated or expected,

"It is believed that the conditions and practices which contributed to the five medical events listed above were identified during the course of investigating the previous medical event of April, 2004. It is further believed that St. Vincent Hospital has implemented corrective action since the event of April, 2004 that has eliminated (or significantly reduced the risk of) recurrence of these conditions/practices."

EXIT SIGNS CONTAINING TRITIUM BELIEVED TO HAVE BEEN TAKEN TO LOCAL LANDFILL


On 09/07/05 during an inventory check it was discovered that 9 exit signs were missing from Building 102C, used as a storage building, at Boeing Company located in Berkeley, MO (suburb of St. Louis). They were last seen in May of 2005. The person that looks after the signs took an extended sick leave for several weeks during July. Three of the Exit signs were made by Self Powered Lighting and the other 6 were from SRB. The original total activity of the 9 Exit Signs was 119 curies and the current total activity of the Exit Signs is now 54 curies. It is believed that the Exit Signs were discarded in a dumpster and then the dumpster was taken to the local landfill. Exit Signs were made between 1988 and 1996.