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Event Notification Report for October 22, 2004

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
10/21/2004 - 10/22/2004

** EVENT NUMBERS **


41133 41135 41136

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Hospital Event Number: 41133
Rep Org: ST. VINCENT HOSPITAL
Licensee: ST. VINCENT HOSPITAL
Region: 3
City: INDIANAPOLIS State: IN
County:
License #: 13-00133-02
Agreement: N
Docket:
NRC Notified By: ED WROBLEWSKI
HQ OPS Officer: STEVE SANDIN
Notification Date: 10/19/2004
Notification Time: 12:05 [ET]
Event Date: 10/11/2004
Event Time: [CST]
Last Update Date: 10/21/2004
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
JULIO LARA (R3)
SANDRA WASTLER (NMSS)

Event Text

MEDICAL EVENT INVOLVING FRACTIONATED DOSE DELIVERY LESS THAN PRESCRIBED

On 10/11/04 a 49 year old female patient received the first of two treatments for endometrial cancer. A total dose of 700 centiGray was prescribed to be delivered in two (2) 350 cGy fractions using a 1500 mm length catheter containing a 7.035 curies Ir-192 source (duration 189 seconds). Due to an error on the part of the Health Physicist, the 995 mm length catheter was used. This resulted in a calculated dose of less than 1 cGy to the thigh at a distance of 505 mm from the intended site. There are no expected adverse consequences.

Both the patient and prescribing physician were informed. A new treatment plan has been developed and the patient rescheduled. Corrective actions are to be determined. The licensee informed Region 3 (Mike Lafranzo).


* * * UPDATE ON 10/21/04 @ 1246 BY ED WROBLEWSKI TO CHAUNCEY GOULD * * *

The following text is an updated corrected version of the above initial report which was submitted by the licensee after consulting with Region 3.

On 10/11/04 a 49 year old female patient received what was to be the first of two High Dose Rate (HDR) treatments for endometrial cancer using a remote afterloading unit. The physician planned two fractions of 350 cGy for a total of 700 cGy at 0.5 cm from the GYN cylinder (2.0cm) wall using a 7 Ci Ir-192 source. The GYN cylinder is connected to the HDR unit using a 1500 mm transfer tube. A treatment of 189 seconds with an active length of 5 cm was to be treated with an indexer position of 1500 mm, Due to an error on the part of the medical physicist, an indexer length of 995 was programmed into the treatment unit. This resulted in the source not entering the patient. The source remained positioned in the transfer tube for the treatment duration at an estimated distance of 35-50 cm from the patient's skin. This resulted in a calculated dose between 1.4 - 4.3 R to the patient's skin. There are no expected adverse consequences.


Notified Reg 3 RDO (Julio Lara) and NMSS EO (Sandra Wastler)

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General Information or Other Event Number: 41135
Rep Org: TEXAS DEPARTMENT OF HEALTH
Licensee: VHS SAN ANTONIO PARTNERS, LP
Region: 4
City: SAN ANTONIO State: TX
County:
License #: L00455-000
Agreement: Y
Docket:
NRC Notified By: JAMES OGDEN
HQ OPS Officer: JEFF ROTTON
Notification Date: 10/19/2004
Notification Time: 16:37 [ET]
Event Date: 06/03/2004
Event Time: [CDT]
Last Update Date: 10/20/2004
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
JACK WHITTEN (R4)
TOM ESSIG (NMSS)

Event Text

AGREEMENT STATE REPORT - MULTIPLE PATIENT OVEREXPOSURE

"A verbal report was received on July 20, 2004, which reported patient doses in excess of 50 Rem to the wrong physical area on treatments involving a Nucletron HDR Microselectron brachytherapy device, Model 080.000, Serial No. 9072. Four patients received wrong doses due to a 7.5 centimeter error in source location from the intended treatment site/plan. Details were vague due to discussion over the phone. A written report would follow.

"The written report date August 2, 2004, was received by this agency on August 6, 2004. The report failed to give details needed by this agency. An Agency investigator was assigned to investigate this incident on August 6, 2004. The investigation conducted on August 18, 2004, determined that an error in catheter length was entered by two different registered therapists as 920 millimeters versus the default and actual length of the catheter of 955 millimeters. The 75 millimeter or 7.5 centimeter error resulted in two sources: a 12.3 curie (02/16/2004) Ir-192 source, Serial No. D35AO131 and a new Ir-192 source installed on 07/08/2004, Serial No. D35A0605, 10.5 curies being positioned outside of each patients body. The error was discovered after one of the four patients developed skin erythema. The patients were to receive boost treatments of 500 centiGray per fraction from the HDR unit to the prescribed location with the total number of fractions varying from 3 to 7 in the physician's written directive. The patients were all being treated for inter uterine cancer. The patients received fractional treatments with the error which varied from 1-5 fractions. Make-up treatments were required on three of the patients to achieve the correct dosage to the treatment site. Some patients received both correct and incorrect treatments from the same therapists.

"The error was discovered on July 8, 2004, when one patient complained of tenderness in one leg. The physician determined that the patient had erythema on her leg, several centimeters from the planned treatment site. The physician's investigation determined the error in catheter length on July 14, 2004, and ordered make-up treatment for his patient on July 15, 2004. A total of four female patients, three radiation oncologists, and three radiation therapists were involved in the treatments and required corrective treatments to three of the four patients. The hospital was reluctant to release dose data on the patients due to concerns of HIPAA privacy standards. After explanation of allowable disclosure to this agency, the Licensee provided the data on October 4, 2004.

"Patient #1 received a non-target tissue dose of 800 rad superficial and 250 rad deep over a three week period. She suffered skin erythema which was treated over a few weeks with rest and a topical ointment. After the erythema was resolved she resumed normal follow-up treatment for her initial disease. Patient #2 received a non-target tissue dose of 400 rad superficial and 150 rad deep over a one week period and exhibited no abnormal reactions. She immediately resumed normal follow-up treatment for her initial disease. Patient #3 received a non-target tissue dose of 1100 rad superficial and 300 rad deep over a three week period. She exhibited no abnormal reactions and resumed normal follow-up treatment for her initial disease. Patient #4 received a non-target tissue dose of 1800 rad superficial and 350 rad deep over a seven week period. She suffered skin erythema and was treated with rest and topical ointment. After the erythema was resolved, she resumed normal follow-up treatment for her initial disease. This is an abnormal occurrence."

Texas Incident # I-8145.

* * * UPDATE FROM J. OGDEN TO M. RIPLEY 0825 ET 10/20/04 * * *

"The correct catheter length is 995 mm vs. the entered length of 920 mm. A difference of 75 mm or 7.5 cm."

Notified R4 DO (Whitten) and NMSS EO (Essig).

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General Information or Other Event Number: 41136
Rep Org: TENNESSEE DIV OF RAD HEALTH
Licensee: DURATEK MEMPHIS GROUP
Region: 1
City: MEMPHIS State: TN
County:
License #: R-79171
Agreement: Y
Docket:
NRC Notified By: DEBRA SHULTS
HQ OPS Officer: STEVE SANDIN
Notification Date: 10/19/2004
Notification Time: 16:15 [ET]
Event Date: 10/05/2004
Event Time: [EDT]
Last Update Date: 10/19/2004
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
RONALD BELLAMY (R1)
JACK WHITTEN (R4)
TOM ESSIG (NMSS)

Event Text

AGREEMENT STATE REPORT INVOLVING SHIPMENT OF PACKAGES WITH REMOVABLE CONTAMINATION

"On October 18, the licensee called the Division [Tennessee Division of Radiological Health] to report that a shipment brokered by Duratek from their facility in Memphis, TN on September 29 arrived at Laguna Verde Power Station near Veracruz, Mexico on October 5 with three boxes exceeding the removable contamination limits of 49CFR173.443. The boxes contained contaminated equipment, to be used at the Power Station during an outage. The equipment was contaminated with mixed fission/activation products. There was no contamination found on the truck. The boxes were decontaminated onsite."

Tennessee Event report ID No.: TN-04-151

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Friday, March 30, 2012