Information Notice 2000-22, Medical Misadministrations Caused by Human Errors Involving Gamma Stereotactic Radiosurgery (Gamma Knife)

Medical Misadministrations Caused by Human Errors Involving Gamma Stereotactic Radiosurgery (Gamma Knife)

ML003761619
Person / Time
Issue date:	12/18/2000
From:	Cool D NRC/NMSS/IMNS
To:
Torres, R, NMSS/IMNS, 415-8112
References
IN-00-022
Download: ML003761619 (7)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 December 18, 2000

NRC INFORMATION NOTICE 2000- 22: MEDICAL MISADMINISTRATIONS CAUSED BY

HUMAN ERRORS INVOLVING GAMMA

STEREOTACTIC RADIOSURGERY

(GAMMA KNIFE)

Addressees

All medical licensees authorized to conduct gamma stereotactic radiosurgery treatments.

Purpose

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

remind addressees of the importance of following written directives and treatment planning

procedures, and the need to pay attention to detail during preparation and administration of

gamma stereotactic radiosurgery. 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 IN are not new NRC requirements; therefore, no

specific action nor written response is required.

Description of Circumstances

NRC has become aware of 16 medical misadministrations, involving gamma stereotactic

radiosurgery, that have occurred during the past few years. Fifteen of these 16 misadministrations were attributed to human error, especially while entering data into a

computer treatment program and during the verification of patient coordinate settings. The

descriptions of the 15 misadministrations are summarized in Attachment 1.

Discussion:

The most common reported human error is the transposition of coordinate settings, mainly the

Y and Z coordinates. Other human errors are the selection of incorrect parameters such as

treatment sites, doses, and exposure times, and failure to follow established procedures.

Licensees have adopted the following corrective actions to prevent recurrence

of misadministrations:

1. A licensee requires two independent checks of the X, Y and Z coordinate settings before

each exposure, instead of one independent check, to reduce the transposition of

coordinates. In a single check, the coordinates are called out and person A sets the

coordinates, then Person B checks them against the written treatment plan. In a double

check, person A sets the coordinates, then Persons B and C independently check them

against the written treatment plan.

2. Another licensee requires a minimum of three staff members to set the X, Y, and Z

coordinates on the stereotactic frame to reduce the probability of transposition errors.

Treatment is administered only after the three staff members concur on the

coordinate settings.

3. A licensee limits the conversations in the treatment room to only those required for the

treatment of the patient, and restricts telephone calls in the treatment control area. These

actions reduce distractions to members of the treatment team.

4. A licensee requires the neurosurgeon, the radiation oncologist, and the medical physicist to

verify the treatment plan before each procedure. The neurosurgeon and either the

radiation physicist or the radiation oncologist has to be physically present during the

treatment. This oversight improves procedure adherence and attention to detail.

5. A licensee requires marking each page of the patient treatment plan with a unique name

and time stamp that the radiation oncologist or medical physicist has to initial before

delivery of the radiosurgery treatment. This prevents the transposition of a patient

treatment sheet from one medical file to another among patients receiving the same type

of treatment on the same day.

The medical physicist participation in the entire treatment-planning process is important, especially during the pretreatment review of the treatment plan. Neurosurgeon and radiation

oncologist collaboration at critical points in the process, such as dose selection, approval of the

written plan, and initiation of the treatment, is also essential. Licensees are reminded that

10 CFR 35.32(a)(1) requires that written directives be prepared before administration of gamma

sterotactic radiosurgery. Subsections 35.32(a)(3) and (4) require that final treatment plans and

related calculations, and each administration, are in accord with the respective written

directives. It is important that written directives and procedures are kept up to date and provide

adequate information. It is also important that management place a high value on staff

following all procedures and directives; that all staff are adequately trained; and that training

programs are effective in relaying necessary information. In all the cases listed in

Attachment 1, written directives and procedures were in place. However, a lack of attention to

detail, failure to adhere to the procedures and directives, or a failure to perform adequate, independent verification of treatment plans, patient identities, and treatment doses, contributed

to misadministrations. 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.

/RA/

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Roberto J. Torres, NMSS

(301) 415-8112 E-mail: rjt@nrc.gov

Attachments:

1. Description of event circumstances

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices 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.

/RA/

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Roberto J. Torres, NMSS

(301) 415-8112 E-mail: rjt@nrc.gov

Attachments:

1. Description of event circumstances

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: ML003761619 OFFICE MSIB C Editor N MSIB N MSIB MSIB N IMNS N

NAME RTorres/RA/ EKraus/fax FBrown/RA/ JHickey/RA/ CTrottier/RA/ DCool/RA/

DATE 9/29/00 10/05/00 10/22/00 10/25/00 12/11/00 12/11/00

& 12/4/00 & 12/01/00 & 12/6/00 & 12/6/00

OFFICIAL RECORD COPY

Attachment 1 DESCRIPTION OF EVENT CIRCUMSTANCES

1. A patient being treated for brain lesions was undergoing the fourth of five planned

treatments, when a treatment site received an unintended repeat dose because of

inattention to detail. The treatment site was supposed to receive 1200 centiGray (cGy)

(rad), but instead received 2400 cGy (rad).

2. A patient being treated for pituitary adenoma received a dose of 1260 cGy (rad) to an

unintended site of his frontal lobe. The unintended site was approximately 4.2 centimeters

(cm) (1.65 inches) away from the intended site. The treatment planning for the patient was

uneventful. A nurse and the medical physicist checked the adjustments on the device

stereotactic frame for accuracy. Nonetheless, when staff members started to set up the

patient for a second administration, they realized the Y and Z coordinates on the

stereotactic frame were transposed on the previous treatment.

3. A gamma knife unit was set up incorrectly and delivered a dose to the wrong site on a

patients brain. A radiosurgery treatment was to be delivered to Patient As left trigeminal

nerve. On that same date, Patient B was also scheduled to receive the same treatment as

Patient A. During the signature phase of treatment plan approval, Patient Bs dose delivery

treatment sheet was inadvertently transposed with that of Patient A. Therefore, Patient A

was treated with the radiosurgery parameters that were intended for Patient B. This

resulted in a dose of 8000 cGy (rad) delivered to the wrong treatment site. The actual dose

received by the intended treatment site was 20 cGy (rad).

4. A patient being treated for an arteriovenous malformation, in the left part of his brain, received treatment to the right side of his brain. During the treatment planning process, the computer software refused several times to accept the correct orientation (as viewed

by the planning team) of the patients image. Eventually, the neurosurgeon and the

medical physicist instructed the computer system to accept the image they believed to be

correct. After initiating the treatment, the physicist noticed that the X coordinates indicated

a definite right-side target and stopped the treatment. The physicist and the neurosurgeon

were unaware that a different angiography room had been used to acquire the patients X-

ray images during the quality assurance (QA) runs. QA tests had been performed in what

the physicist believed to be the only angiographic suite. This room was equipped in such a

way that the lateral X-ray tube could only be on the patients right side, with the patient in a

supine position. The actual angiographs were performed in another room where the tube

focus was on the patients left side.

5. A patient received a dose of 3000 cGy (rad) to the intended site of his brain, instead of the

prescribed dose of 2300 cGy (rad). This event was caused because the licensee did not

follow the treatment plan and used an incorrect collimator helmet.

Attachment 1 6. A patient received a dose 54.5 percent below the intended dose. The prescribed dose was

2200 cGy (rad) and the patient received a dose of 1000 cGy (rad). The treatment

physician failed to enter the prescribed dose into the treatment planning system. This

resulted in the systems default value (1000 cGy) (rad) being used for the treatment. The

error was missed by all three team members involved in the treatment planning.

7. A patient received a total treatment dose that differed from the prescribed dose by more

than 10 percent. As the third treatment site was being prepared for treatment

administration, the licensee discovered that the patients position would have to be

changed from supine to prone, to physically achieve the appropriate coordinates. When

replanning the third area of treatment, the neurosurgeon and the medical physicist realized

the Y and Z coordinates were transposed during the previous treatment.

8. A patient was prescribed a treatment of 9000 cGy (rad) to the left trigeminal nerve of his

brain. However, the treatment was actually administered to the right trigeminal nerve. The

medical physicist had inadvertedly prepared a treatment plan for the wrong side of the

patients head and the radiation oncologist (authorized user) signed the treatment plan

without properly verifying the neurosurgeons request identifying the correct site.

9. A patient received treatment to an unintended area of his brain. The treatment plan called

for three doses of radiation. The first treatment was set up and delivered to the patient.

When the coordinates for the second treatment were set, it was discovered that the Y and

Z coordinates had been transposed on the first treatment. The prescribed dose for the first

treatment was 1100 cGy (rad), but 50 cGy (rad) were administered. The licensee indicated

that possible contributing factors to this event were: a) the reduction to two staff members, instead of the usual three, for setting up the patient; and b) the Z coordinate was set before

attaching the Z bar to the stereotactic frame.

10. A patient received a dose of 2600 cGy (rad) to the first of three lesions, instead of the

prescribed dose of 1600 cGy (rad). During preparation of the treatment plan for the

second lesion, the settings for the first treatment site were unintentionally used. This

resulted in two treatments to the first lesion. The error was not identified, even though the

neurosurgeon and the radiation oncologist reviewed and signed the treatment plan.

11. A patient being treated for brain cancer received a therapeutic underdose of 12.3 percent.

The licensee selected the wrong-year date in the treatment planning system, which

resulted in the administration of 1052 cGy (rad) instead of the prescribed dose of 1200 cGy

(rad). The licensee failed to recognize a computer warning that the entered treatment date

differed from the system date.

12. A patient received treatment to an unintended area of his brain, resulting in a dose of 500

cGy (rad) being delivered 1 to 5 cm (0.4 to 2 inches) from the intended location. An

error in treatment geometry occurred because licensee staff members transposed the

Y and Z coordinates.

Attachment 1 13. A patient received treatment to an unintended area of his brain in excess of 1000 cGy

(rad). The treatment plan that was developed indicated a single exposure of 1600 cGy

(rad) to a brain lesion. One of the seven parameter settings of the gamma knife, the "left

Y" coordinate, was erroneously set, resulting in a 5-millimeter (0.2 inch) translocation of the

treatment volume. This event was caused by one member of the treatment team setting

an initial erroneous coordinate setting, and by another member of the treatment team

failing to independently verify the coordinate setting.

14. A patient received a therapeutic overdose to the intended part of his brain. The dose was

11 percent greater than the prescribed dose. The authorized user failed to enter the

correct exposure time in the treatment-planning software system, and the exposure time

from the previous treatment fraction was used.

15. A patient received treatment to an unintended area of his brain, resulting in a dose of 460

cGy (rad) being delivered 11-millimeter (0.43 inches) from the intended location. The

radiosurgery treatment prescribed three administrations of 1200 cGy (rad) each to a tumor

volume. When the licensee started setting up the coordinates for the second

administration, it was discovered that the Y and Z coordinates had been transposed on the

first administration. The event was caused because the licensee had not checked the

coordinates of the patients head frame against those required by the written treatment

plan prior to the first treatment administration.

Attachment 2 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2000-19 Implementation of Human Use 12/05/2000 All medical use licensees

Research Protocols Involving

U.S. Nuclear Regulatory

Commission Regulated

Materials

2000-18 Substandard Material Supplied 11/29/2000 All 10 CFR Part 50 licensees and

by Chicago Bullet Proof applicants

Systems All category 1 fuel facilities

All 10 CFR Part 72 licensees and

applicants

2000-16 Potential Hazards Due to 10/5/2000 All licensees that process

Volatilization of Radionuclides unsealed byproduct material

2000-15 Recent Events Resulting in 9/29/2000 All radiography licensees

Whole Body Exposures

Exceeding Regulatory Limits

2000-12 Potential Degradation of 9/21/2000 All holders of licenses for nuclear

Firefighter Primary Protective power, research, and test

Garments reactors and fuel cycle facilities

2000-11 Licensee Responsibility for 8/7/2000 All U.S. NRC 10 CFR Part 50 and

Quality Assurance Oversight of Part 72 licensees, and Part 72 Contractor Activities Regarding Certificate of Compliance holders

Fabrication and Use of Spent

Fuel Storage Cask Systems

2000-10 Recent Events Resulting in 7/18/2000 All material licensees who

Extremity Exposures prepare or use unsealed

Exceeding Regulatory Limits radioactive materials, radio- pharmaceuticals, or sealed

sources for medical use or for

research and development

2000-07 National Institute for 4/10/2000 All holders of operating licenses

Occupational Safety and for nuclear power reactors, non- Health Respirator User Notice: power reactors, and all fuel cycle

Special Precautions for Using and material licensees required to

Certain Self-Contained have an NRC approved

Breathing Apparatus Air emergency plan

Cylinders

Attachment 3 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

______________________________________________________________________________________

2000-21 Detached Check Valve Disc 12/15/2000 All holders of OL for nuclear

Not Detected by Use of power reactors except those who

Acoustic and Magnetic have ceased operations and have

Nonintrusive Test Techniques certified that fuel has been

permanently removed from the

reactor

2000-20 Potential Loss of Redundant 12/11/2000 All holders of operating licenses

Safety Related Equipment Due or construction permits for nuclear

to Lack of a High-Energy Line power reactors

Break Barrier

2000-19 Implementation of Human Use 12/05/2000 All medical use licensees

Research Protocols Involving

U.S. Nuclear Regulatory

Commission Regulated

Materials

2000-18 Substandard Material Supplied 11/29/2000 All 10 CFR Part 50 licensees and

by Chicago Bullet Proof applicants. All category 1 fuel

Systems facilities. All 10 CFR Part 72 licensees and applicants

2000-17 S1 Crack In Weld Area of Reactor 11/16/2000 All holders of OL for nuclear

Coolant System Hot Leg Piping power reactors except those who

At V.C. Summer have ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel

2000-17 Crack In Weld Area of Reactor 10/18/2000 All holders of OL for nuclear

Coolant System Hot Leg Piping power reactors except those who

At V.C. Summer have ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel

2000-16 Potential Hazards Due to 10/5/2000 All NRC licensees that process

Volatilization of Radionuclides unsealed byproduct material

______________________________________________________________________________________

OL = Operating License

CP = Construction Permit