Information Notice 1995-39, Brachytherapy Incidents Involving Treatment Planning Errors

Brachytherapy Incidents Involving Treatment Planning Errors

ML031060275
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	09/19/1995
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-95-039, NUDOCS 9509130018
Download: ML031060275 (9)

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UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 September 19, 1995 NRC INFORMATION NOTICE 95-39: BRACHYTHERAPY INCIDENTS INVOLVING TREATMENT

PLANNING ERRORS

Addressees

All U.S. Nuclear Regulatory Commission Medical Licensees.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information

notice to alert addressees to brachytherapy incidents involving treatment

planning errors. It is expected that recipients will review the information

for applicability to their facilities and consider actions, as appropriate, to

avoid similar problems. However, suggestions contained in this information

notice are not new NRC requirements; therefore, no specific action nor written

response is required.

Description of Circumstances

NRC has become aware of the following brachytherapy incidents related to

treatment planning errors:

1) On November 21, 1994, an NRC licensee discovered that an error had

occurred during the programming of a high-dose-rate (HDR) Gamma Med II-i

brachytherapy device on November 18, 1994. While programming treatment

data into the HDR unit, the technologist failed to press the AUTOMATIC

TIME FACTOR button. After entering the dwell positions and the total

treatment time, the technologist attempted to start the treatment by

pressing the START and SOURCE IN IRRAD. POS. buttons. The HDR unit

displayed an error message on the screen indicating the need for MANUAL

TIME FACTOR. The technologist interpreted this to mean that the

computer had not received the total treatment time data and reentered

the data. The total treatment time data were inadvertently used as the

MANUAL TIME FACTOR, resulting in the administration of approximately

twice the intended radiation dose. The failure of the technologist to

press the AUTOMATIC TIE FACTOR button, during initial entry of the

treatment data, was exacerbated by an apparent defect, in the GAMUHR

card, that permitted the technologist to manually enter and accept the

inappropriate decay factor during the programming process. The device

contained a nominal 370-giga becquerel (GBq) (10-curie (Ci)) iridium-192 sealed source. As a result, the patient received a dose of 12 Gray (Gy)

(1200 rad) to the vaginal cavity instead of the prescribed dose of 6.Gy

(600 rad).

2) On September 23, 1994, a licensee informed Region III that a patient

undergoing a uterine brachytherapy implant received a 31 percent

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IN 95-39 September 19, 1995 underdose. On September 13, 1994, the patient was implanted with two

cesium-137 (Cs-137) brachytherapy sources, in an ovoid applicator, to

deliver 65 Gy (6500 rad) to the uterine lining, in approximately

48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />. During review of the completed treatment, the licensee's

medical physicist determined that the wrong tissue volume was used

during the treatment planning process, resulting in a smaller volume

being treated than the administering physician intended. Although the

physician reviewed and approved the treatment plan before

administration, it was not apparent that a smaller tissue volume was

represented in the plan. The licensee believes that the dosimetrist who

prepared the treatment plan used incorrect spatial coordinates to define

the treatment volume and failed to verify the dose calculations. The

licensee determined that the treatment of the smaller volume resulted in

the delivery of 45 Gy (4500 rad) to the intended treatment volume, which

was a 31 percent underdose. To compensate for the 20 Gy (2000 rad)

underdose, the administering physician modified a previously intended

boost dose, using external beam therapy (via a linear accelerator).

3) An Agreement State licensee reported an event in which an incorrect dose

conversion factor was used for planning a treatment. One patient was

treated with three Cs-137 seeds during a gynecological implant procedure

during the period of May 4-8, 1994. The patient received approximately

91.3 Gy (9130 rad) to the treatment area, which was about 283 percent

greater than prescribed. Further investigation revealed that the error

involved six additional patients, with the patients receiving doses from

37 percent to 144 percent in excess of their intended doses. The

calculation error was caused when the physicist entered the wrong gamma

constant when editing the treatment planning program. The physicist was

attempting to convert from 'milligram radium equivalent' to "millicurie"

and entered 3.256 'radium' instead of "millicurie," resulting in an

error ratio that was 2.5 times greater than expected.

4) On April 8, 1994, an NRC licensee reported an incident involving a data

entry error in the treatment planning process. The written directive

specified two fractions of 6 Gy (600 rad) per fraction for a total dose

of 12 Gy (1200 rad). Before the first treatment, a radiation therapist

correctly entered the treatment parameters into the GammaMed II-i HDR.

A second radiation therapist and the radiation physicist verified that

this entry of data was correct. The GammaMed II-i HDR device used the

European date format (day-month-year) for this parameter. At the time

of the treatment, the radiation therapist recalled the correct treatment

parameters from the computer memory, but inadvertently entered the

treatment date in the incorrect format (i.e., 4.06.94 instead of

6.04.94). Because the HDR computer' automatically adjusts for source

decay, the exposure time was modified by a factor of 3.17 (for June 4)

instead of the required modifying factor of 1.83 (for April 6). This

resulted in an administered fractional dose of 10.39 Gy (1039 rad)

instead of the intended prescribed 6 Gy (600 rad). However, the total

prescribed dose of 12 Gy (1200 rad) was not exceeded because the error

was detected before the second treatment was administered.

IN 95-39 September 19, 1995 5) On October 11, 1993, an NRC licensee reported a therapeutic

misadministration, discovered during a routine review of records, that

occurred on April 23, 1993, during a brachytherapy procedure involving a

high-dose-rate (HDR) remote afterloader. According to the medical

physicist, a patient was scheduled to receive vaginal brachytherapy

treatment using a Nucletron HDR unit with a 157.14 GBq (4.247 Ci)

iridium-192 source. The prescribed dose for the fraction was 5 Gy

(500 rad). During the planning of the second of the three treatments, an error was made In the input of the offset distance. Instead of

992 millimeter (mm), a distance of 920 mm was entered. The source was

programmed to travel 45 mm outward from the offset distance in nine

increments of 5 mm each. The medical physicist indicated that the

treatment progressed as was planned. However, because of the erroneous

input for the offset distance, a portion of the dose was administered to

the wrong site.

6) On August 18, 1993, a therapeutic misadministration occurred at a

licensee's facility when a patient who was scheduled to receive a 6 Gy

(600 rad) dose of radiation to his esophagus actually received a 10 Gy

(1000 rad) dose. The licensee identified the error during a routine

physics check conducted that same day. The licensee indicated that a

treatment plan was developed to deliver the 6 Gy (600 rad) dose and that

this plan was reviewed by the physicist and physician and found to be

correct. However, before administering the dose, the physicist

reaccessed the HDR treatment planning system to modify a noncritical

factor. The physicist reported having a problem maneuvering between the

various menus in the treatment planning system, which involved pressing

the 'Esc' key several times. This caused the treatment planning program

to change the value of the treatment dose to 10 Gy (1000 rad).

According to the licensee, the modified plan was put into the HDR

control computer without an additional in-depth review and the treatment

was delivered.

Discussion

The incidents listed above demonstrate the importance of following plans and

procedures to meet the objective stated in 10 CFR 35.32(a)(3) that final

treatment plans and related calculations are in accordance with the written

directive. Attention to details in treatment planning and independent

verification of treatment plans may be involved in meeting this objective. If

independent verification of treatment plans is so relied upon, it should

include verification of the data used to calculate the initial treatment plan, as well as the calculations. It is important to note that recalculation of

the treatment plan from the same data set used to prepare the initial

treatment may not catch errors introduced by initially inputting incorrect

treatment parameters.

IN 95-39 September 19, 1995 This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

the technical contact listed below, or the appropriate NRC regional office.

D nald A. Cool, D$4'ecto

vis on of Industrial and

Me ical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: James A. Smith, NMSS

(301) 415-7904 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

Attachment 1 IN 95-39 September 19, 1995 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

95-29 Oversight of Design and 06/07/95 All holders of OLs or CPs

and Fabrication Activities for nuclear power reactors.

for Metal Components Used

in Spent Fuel Dry Storage Independent spent fuel

Systems storage installation

designers and fabricators.

95-28 Emplacement of Support 06/05/95 All holders of OLs or CPs

Pads for Spent Fuel Dry for nuclear power reactors

Storage Installations at

Reactor Sites

95-25 Valve Failure during 05/11/95 All U.S. Nuclear Regulatory

Patient Treatment with Commission Medical

Gamma Stereotactic Licensees.

Radiosurgery Unit

94-64, Reactivity Insertion Trans- 04/06/95 All holders of OLs or CPs

Supp. 1 ient and Accident Limits for Nuclear Power Reactors

for High Burnup Fuel and all fuel fabrication

licensees.

95-07 Radiopharmaceutical Vial 01/27/95 All U.S. Nuclear Regulatory

Breakage during Preparation Commission medical licensees

authorized to use byproduct

material for diagnostic

procedures.

95-01 DOT Safety Advisory: 01/04/95 All U.S. Nuclear Regulatory

High Pressure Aluminum Commission licensees.

Seamless and Aluminum

Composite Hoop-Wrapped

Cylinders

94-89 Equipment Failures at 12/28/94 All U.S. Nuclear Regulatory

Irradiator Facilities Commission irradiator

licensees.

89-25, Unauthorized Transfer of 12/07/94 All fuel cycle and material

Rev. 1 Ownership or Control of licensees.

Licensed Activities

Attachment 2 IN 95-39 September 19, 1995 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

95-38 Degradation of Boraflex 09/08/95 All holders of OLs or CPs

Neutron Absorber in for nuclear power reactors.

Spent Fuel Storage Racks

95-37 Inadequate Offsite Power 09/07/95 All holders of OLs or CPs

System Voltages during for nuclear power reactors.

Design-Basis Events

95-36 Potential Problems with 08/29/95 All holders of OLs or CPs

Post-Fire Emergency for nuclear power reactors.

Lighting

95--35 Degraded Ability of 08/28/95 All holders of OLs or CPs

Steam Generators to for pressurized water

Remove Decay Heat by reactors (PWRs).

Natural Circulation

95-34 Air Actuator and Supply 08/25/95 All holders of OLs or CPs

Air Regulator Problems in for nuclear power reactors.

Copes-Vulcan Pressurizer

Power-Operated Relief Valves

93-83, Potential Loss of Spent 08/24/95 All holders of OLs or CPs

Supp. 1 Fuel Pool Cooling After a for nuclear power reactors.

Loss-of-Coolant Accident

or a Loss of Offsite Power

95-33 Switchgear Fire and 08/23/95 All holders of OLs or CPs

Partial Loss of Offsite for nuclear power reactors.

Power at Waterford

Generating Station, Unit 3

95-10, Potential for Loss of 08/11/95 All holders of OLs or CPs

Supp. 2 Automatic Engineered for nuclear power reactors.

Safety Features Actuation

95-32 Thermo-Lag 330-1 Flame 08/10/95 All holders of OLs or CPs

Spread Test Results for nuclear power reactors.

OL - Operating License

CP - Construction Permit

K>1- IN 95-39 September 19, 1995 This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

the technical contact listed below, or the appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: James A. Smith, NMSS

(301) 415-7904 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

DOC NAME: 95-39.IN

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DATE 08/22/95 09/06/95 09/11 /95 09 /11 /95 OFFICIAL RECORD COPY

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IN 95- September 1995 This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

the technical contact listed below, or the appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: James A. Smith, NMSS

(301) 415-7904 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

loses IMAB-1800 INAB 1161.and IMAB 747 OFC IMAB E IMAB I E IMAB E Tech Ed

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DATE 08/22/95 09/06/95 1 AP __7 /___/

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IN 95- August , 1995 This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

the technical contact listed below, or the appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: James A. Smith, NMSS

(301) 415-7904 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

loses INAB-1800 IMAB 1161.and IMAB 747 -*

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