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

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Medical Misadministrations Caused by Human Errors Involving Gamma Stereotactic Radiosurgery (Gamma Knife)
ML003761619
Person / Time
Issue date: 12/18/2000
From: Cool D A
NRC/NMSS/IMNS
To:
Torres, R, NMSS/IMNS, 415-8112
References
IN-00-022
Download: ML003761619 (7)
v • d • e


December 18, 2000

NRC INFORMATION NOTICE 2000- 22:MEDICAL MISADMINISTRATIONS CAUSED BYHUMAN 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) toremind 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 radiosurger It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar problem 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 stereotacticradiosurgery, that have occurred during the past few year 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 theY and Z coordinate 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 coordinate In a "single check," the coordinates are called out and person A sets the coordinates, then Person B checks them against the written treatment pla 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 Zcoordinates on the stereotactic frame to reduce the probability of transposition error 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 thetreatment of the patient, and restricts telephone calls in the treatment control are These actions reduce distractions to members of the treatment team.4.A licensee requires the neurosurgeon, the radiation oncologist, and the medical physicist toverify the treatment plan before each procedur The neurosurgeon and either the radiation physicist or the radiation oncologist has to be physically present during the treatmen This oversight improves procedure adherence and attention to detail.5.A licensee requires marking each page of the patient treatment plan with a unique nameand time stamp that the radiation oncologist or medical physicist has to initial before delivery of the radiosurgery treatmen 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 pla 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 essentia Licensees are reminded that 10 CFR 35.32(a)(1) requires that written directives be prepared before administration of gamma sterotactic radiosurger 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 directive It is important that written directives and procedures are kept up to date and provide adequate informatio 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 informatio In all the cases listed in Attachment 1, written directives and procedures were in plac 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 misadministration This information notice requires no specific action nor written respons If you have anyquestions 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

Technical Contact:

Roberto J. Torres, NMSS (301) 415-8112 E-mail: rjt@nrc.gov

Attachments:

Description of event circumstances List of Recently Issued NMSS Information Notices List of Recently Issued NRC Information Notices This information notice requires no specific action nor written respons If you have anyquestions about the information in this notice, please contact the technical contact listed below or the appropriate NRC regional office./RA/Donald A. Cool, DirectorDivision of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Technical Contact:

Roberto J. Torres, NMSS (301) 415-8112 E-mail: rjt@nrc.gov

Attachments:

Description of event circumstances List of Recently Issued NMSS Information Notices List of Recently Issued NRC Information NoticesDOCUMENT NAME:ML003761619OFFICEMSIBC EditorN MSIBNMSIB MSIB NIMNSN NAMERTorres/RA/EKraus/fax FBrown/RA/JHickey/RA/ CTrottier/RA/ DCool/RA/ DATE9/29/00& 12/4/00 10/05/00 & 12/01/00 10/22/00& 12/6/0010/25/00& 12/6/0012/11/00 12/11/00 OFFICIAL RECORD COPY Attachment 1 DESCRIPTION OF EVENT CIRCUMSTANCES1.A patient being treated for brain lesions was undergoing the fourth of five plannedtreatments, when a treatment site received an unintended repeat dose because of inattention to detai 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 anunintended site of his frontal lob The unintended site was approximately 4.2 centimeters (cm) (1.65 inches) away from the intended sit The treatment planning for the patient was uneventfu A nurse and the medical physicist checked the adjustments on the device stereotactic frame for accurac 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 apatient's brai A radiosurgery treatment was to be delivered to Patient A's left trigeminal nerv On that same date, Patient B was also scheduled to receive the same treatment as Patient During the signature phase of treatment plan approval, Patient B's dose delivery treatment sheet was inadvertently transposed with that of Patient Therefore, Patient A was treated with the radiosurgery parameters that were intended for Patient 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 brai During the treatment planning process, the computer software refused several times to accept the "correct" orientation (as viewed by the planning team) of the patient's imag Eventually, the neurosurgeon and the medical physicist instructed the computer system to accept the image they believed to be correc After initiating the treatment, the physicist noticed that the X coordinates indicated a definite right-side target and stopped the treatmen The physicist and the neurosurgeon were unaware that a different angiography room had been used to acquire the patient's X-

ray images during the quality assurance (QA) run QA tests had been performed in what the physicist believed to be the only angiographic suit This room was equipped in such a way that the lateral X-ray tube could only be on the patient's right side, with the patient in a supine positio The actual angiographs were performed in another room where the tube focus was on the patient's left side.5.A patient received a dose of 3000 cGy (rad) to the intended site of his brain, instead of theprescribed dose of 2300 cGy (rad). This event was caused because the licensee did not follow the treatment plan and used an incorrect collimator helme Attachment 1 .A patient received a dose 54.5 percent below the intended dos The prescribed dose was2200 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 syste This resulted in the system's 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 morethan 10 percen As the third treatment site was being prepared for treatment administration, the licensee discovered that the patient's position would have to be changed from supine to prone, to physically achieve the appropriate coordinate 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 hisbrai However, the treatment was actually administered to the right trigeminal nerv The medical physicist had inadvertedly prepared a treatment plan for the wrong side of the patient's head and the radiation oncologist (authorized user) signed the treatment plan without properly verifying the neurosurgeon's request identifying the correct site. 9.A patient received treatment to an unintended area of his brai The treatment plan calledfor three doses of radiatio The first treatment was set up and delivered to the patien When the coordinates for the second treatment were set, it was discovered that the Y and Z coordinates had been transposed on the first treatmen The prescribed dose for the first treatment was 1100 cGy (rad), but 50 cGy (rad) were administere 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 theprescribed dose of 1600 cGy (rad). During preparation of the treatment plan for the second lesion, the settings for the first treatment site were unintentionally use This resulted in two treatments to the first lesio 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 500cGy (rad) being delivered 1 to 5 cm (0.4 to 2 inches) from the intended locatio An error in treatment geometry occurred because licensee staff members transposed the Y and Z coordinate Attachment 1 3.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 lesio 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 volum 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 brai The dose was11 percent greater than the prescribed dos 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 460cGy (rad) being delivered 11-millimeter (0.43 inches) from the intended locatio The radiosurgery treatment prescribed three administrations of 1200 cGy (rad) each to a tumor volum 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 administratio The event was caused because the licensee had not checked the coordinates of the patient's head frame against those required by the written treatment plan prior to the first treatment administratio Attachment 2 LIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICES_____________________________________________________________________________________InformationDate of Notice N SubjectIssuanceIssued to

_____________________________________________________________________________________2000-19Implementation of Human UseResearch Protocols Involving U.S. Nuclear Regulatory Commission Regulated Materials12/05/2000All medical use licensees2000-18Substandard Material Suppliedby Chicago Bullet Proof Systems11/29/2000All 10 CFR Part 50 licensees andapplicants All category 1 fuel facilities All 10 CFR Part 72 licensees and applicants2000-16Potential Hazards Due toVolatilization of Radionuclides10/5/2000All licensees that processunsealed byproduct material2000-15Recent Events Resulting inWhole Body Exposures Exceeding Regulatory Limits9/29/2000All radiography licensees2000-12Potential Degradation ofFirefighter Primary Protective Garments9/21/2000All holders of licenses for nuclearpower, research, and test reactors and fuel cycle facilities2000-11Licensee Responsibility forQuality Assurance Oversight of Contractor Activities Regarding Fabrication and Use of Spent Fuel Storage Cask Systems8/7/2000All U.S. NRC 10 CFR Part 50 andPart 72 licensees, and Part 72 Certificate of Compliance holders2000-10Recent Events Resulting inExtremity Exposures Exceeding Regulatory Limits7/18/2000All material licensees whoprepare or use unsealed radioactive materials, radio- pharmaceuticals, or sealed sources for medical use or for research and development2000-07National Institute forOccupational Safety and Health Respirator User Notice:

Special Precautions for Using Certain Self-Contained Breathing Apparatus Air Cylinders4/10/2000All holders of operating licensesfor nuclear power reactors, non- power reactors, and all fuel cycle and material licensees required to have an NRC approved emergency plan

______________________________________________________________________________________OL = Operating License CP = Construction PermitAttachment 3 LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICES_____________________________________________________________________________________InformationDate of Notice N SubjectIssuanceIssued to______________________________________________________________________________________2000-21Detached Check Valve DiscNot Detected by Use of Acoustic and Magnetic Nonintrusive Test Techniques12/15/2000All holders of OL for nuclearpower reactors except those who have ceased operations and have certified that fuel has been permanently removed from the reactor2000-20Potential Loss of RedundantSafety Related Equipment Due to Lack of a High-Energy Line Break Barrier12/11/2000All holders of operating licensesor construction permits for nuclear power reactors2000-19Implementation of Human UseResearch Protocols Involving U.S. Nuclear Regulatory Commission Regulated Materials12/05/2000All medical use licensees2000-18Substandard Material Suppliedby Chicago Bullet Proof Systems11/29/2000All 10 CFR Part 50 licensees andapplicant All category 1 fuel facilitie All 10 CFR Part 72 licensees and applicants2000-17 S1Crack In Weld Area of ReactorCoolant System Hot Leg Piping At V.C. Summer11/16/2000All holders of OL for nuclearpower reactors except those who have ceased operations and have certified that fuel has been permanently removed from the reactor vessel2000-17Crack In Weld Area of ReactorCoolant System Hot Leg Piping At V.C. Summer10/18/2000All holders of OL for nuclearpower reactors except those who have ceased operations and have certified that fuel has been permanently removed from the reactor vessel2000-16Potential Hazards Due toVolatilization of Radionuclides10/5/2000All NRC licensees that processunsealed byproduct material


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