21788 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices
MATTERS TO BE CONSIDERED: longer wish to receive it, or would like Consolidated Edison Company, located to be added to the distribution, please about 24 miles north of New York City. Week of April 30, 2001 contact the office of the Secretary, Nature and Probable Consequences— There are no meetings scheduled for Washington, DC 20555 (301–415–1969). On February 15, 2000, at 7:17 p.m., the the Week of April 30, 2001. In addition, distribution of this meeting Indian Point Unit 2 nuclear plant Week of May 7, 2001—Tentative notice over the Internet system is experienced a steam generator tube available. if you are interested in failure which required the declaration of Thursday, May 10, 2001 receiving this Commission meeting an ‘‘Alert’’ (the second lowest of four 10:25 a.m.—Affirmation Session schedule electronically, please send an emergency classifications in the NRC- (Public Meeting) (If needed). electronic message to [email protected]. required emergency response plan) at 7:29 p.m., and a manual reactor trip at 10:30 a.m.—Briefing on Office of Dated: April 26, 2001. Nuclear Regulatory Research (RES) 7:30 p.m. The steam generator is a heat David Louis Gamberoni, Programs and Performance (Public exchanger which allows heat to pass Meeting) (Contact: James Johnson, 301– Technical Coordinator, Office of the from the reactor (primary system) to the Secretary. 415–6802). turbine generator (secondary system). It [FR Doc. 01–10955 Filed 4–27–01; 12:20 pm] also provides the boundary between the Friday, May 11, 2001 BILLING CODE 7590–01–M radioactive primary system and the non- 10:30 a.m.—Meeting with Advisory radioactive secondary system. At Indian Committee on Reactor Safeguards Point Unit 2 there are four steam (ACRS) (Public Meeting) (Contact: John NUCLEAR REGULATORY generators and each steam generator has Larkins, 301–415–7360). COMMISSION approximately 3300 tubes. On February 15, the failure of one of these tubes Week of May 14, 2001—Tentative Report to Congress on Abnormal allowed reactor water to leak into the Occurrences Fiscal Year 2000; There are no meetings scheduled for secondary system. By 8:31 p.m. the Dissemination of Information the Week of May 14, 2001. operators had taken steps to isolate the Week of May 21, 2001—Tentative Section 208 of the Energy steam generator which contained the Reorganization Act of 1974 (Pub. L. 93– leaking tube. After the steam generator There are no meetings scheduled for was isolated, the operators began to cool the Week of May 21, 2001. 438) identifies an abnormal occurrence (AO) as an unscheduled incident or down the plant. At 9:02 p.m. they were Week of May 28, 2001—Tentative event that the U.S. Nuclear Regulatory forced to suspend the cooldown process when they realized they had Wednesday, May 30, 2001 Commission (NRC) determines is significant from the standpoint of public inadvertently established an excessive 10:25 a.m.—Affirmation Session health or safety. The Federal Reports cooldown rate. This excessive cooldown (Public Meeting) (If needed). Elimination and Sunset Act of 1995 rate caused a rapid reduction in reactor coolant system (pressurizer) level. To Week of June 4, 2001—Tentative (Pub. L. 104–66) requires that AOs be reported to Congress annually. During restore the level the licensee pumped Tuesday, June 5, 2001 borated water into the reactor coolant fiscal year 2000, nine events that system using the safety injection system. 9:25 a.m.—Affirmation Session occurred at facilities licensed or After the level was restored the (Public Meeting) (If needed). otherwise regulated by the NRC and/or operators resumed the cooldown and 2 p.m.—Discussion of Management the Agreement States were determined reached cold shutdown at 4:57 p.m on issues (Closed-Ex. 2). to be AOs. These events are discussed February 16, 2000. The licensee exited below. As required by Section 208, the Wednesday, June 6, 2001 the ‘‘Alert’’ emergency classification at discussion for each event includes the 10:30 a.m.—All Employees Meeting 6:50 p.m. that day. date and place, the nature and probable (Public Meeting). The steam generator tube failure 1:30 p.m.—All Employees Meeting consequences, the cause or causes, and resulted in an initial primary-to- (Public Meeting). the action taken to prevent recurrence. secondary leak of reactor coolant of The schedule for Commission Each event is also being described in approximately 146 gallons per minute, meetings is subject to change on short NUREG–0090, Vol. 23, ‘‘Report to and required an ‘‘Alert’’ declaration. notice. To verify the status of meetings Congress on Abnormal Occurrences, This event involved some procedural call (recording)—(301) 415–1292. Fiscal Year 2000.’’ This report will be and equipment issues that challenged Contact person for more information: available electronically at the NRC Web operators, complicated the event David Louis Gamberoni (301) 415–1651. site
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As a result, degraded tubes were Fuel Cycle Facilities (Other Than April 13, 2000. The employee was allowed to remain in service during Nuclear Power Plants) examined by a physician, who plant operation, which ultimately led to None of the events that occurred at identified no immediate health effects. a steam generator tube failure. the fuel cycle facilities during fiscal year Due to the inability of either the NRC or Cause or Causes— The event was 2000, was determined to be significant the licensee to precisely estimate the likely exposure to the employee’s finger caused by primary water stress enough to be reported as an AO to and thumb, long-term health effects corrosion cracking (PWSCC) flaws in Congress. could not be predicted. steam generator tubes. There were Other NRC Licensees (Industrial During its investigation of the March deficiencies in the overall direction and Radiographers, Medical Institutions, 31, 2000, event, Mallinckrodt identified execution of the 1997 steam generator etc.) other employee overexposures that in-service examinations at Indian Point occurred in the preceding 5 years during The following three events occurred Unit 2. Specifically, the licensee did not the performance of two routine at facilities licensed or otherwise identify the presence of PWSCC flaws in operations. As a result of the first regulated by the NRC during fiscal year steam generator tubes and remove these routine operation, 11 employees 2000 and were determined to be tubes from service, despite involved in the hand-labeling of vials significant enough to be reported as AOs opportunities to do so. As a result, tubes containing millicurie quantities of to Congress. with PWSCC were left in service indium-111 (In-111) (a State-regulated, following the 1997 steam generator 00–2 Overexposures at Mallinckrodt, non-NRC licensed material) received inspection until one of these tubes Inc., in Maryland Heights, Missouri extremity doses ranging from 500 mSv failed on February 15, 2000, when the (50 rem) to 3,200 mSv (320 rem) Date and Place—From 1995 through reactor was at 100 percent power. shallow-dose equivalent. In addition to 2000; Mallinckrodt, Inc.; Maryland these doses from In-111, the 11 Heights, Missouri. Actions Taken To Prevent Recurrence employees had also received doses from Nature and Probable Consequences— NRC-regulated material, typically less Licensee—The licensee performed the On March 31, 2000, a contract employee than 5 percent of their total extremity necessary actions to protect the health who was providing services for and safety of the public. Before the doses. Mallinckrodt, Inc., was attempting to The second operation involved the event, the licensee was in the process of correct flow problems with a 703,000 handling of unshielded and partially implementing a station improvement megabecquerel (19 curie) molybdenum- shielded vials and syringes containing program. This event demonstrated the 99/technetium-99m generator. The radioactive material (State- and NRC- need for continuous management employee performed the operation in a regulated material) in a sterility testing attention to planned improvements to glove box. The employee’s initial laboratory. As a result of this operation ensure they are timely and effective. attempts to correct the generator Mallinckrodt identified four employees Subsequently the licensee made the problem were not successful. The who received extremity doses ranging decision to replace all four steam employee then removed the generator from 680 mSv (68 rem) to 960 mSv (96 generators prior to returning to power. column containing the radioactive rem) shallow-dose equivalent. The industry completed a lessons- material from its shield and determined Cause or Causes—The causes of the learned report based on the Indian Point that the inlet line was not connected March 31, 2000, event were insufficient Unit 2 steam generator tube failure and the outlet line was bent at an angle. training to ensure that the employee event and provided it to the NRC on Holding the unshielded column in his understood the difference between October 26, 2000. right hand, the employee corrected the radioactive contamination and radiation NRC—The NRC reviewed the causes, problems with the inlet and outlet lines. and inadequate oversight of the This process took between 10 and 20 safety implications, and licensee actions laboratory. The written, approved seconds to complete. Dose rates at the following the event. Information Notice procedure on the employee’s assigned location of the column held by the 2000–09, ‘‘Steam Generator Tube duties did not allow the removal of the employee were calculated to be Failure at Indian Point Unit 2,’’ was generator column during manufacturing. approximately 510 mSv (51 rem) per issued on June 28, 2000, to alert other However, an ad hoc procedure had been second. As a result the employee’s licensees to this event. A Notice of developed by the staff of the laboratory thumb and index finger of the right Violation was issued to Indian Point 2 that was not known to, or approved by, hand received a dose ranging from 5,100 on November 20, 2000. A lessons- the management outside the laboratory. mSv (510 rem) to 11,200 mSv (1,120 The ad hoc procedure allowed the learned report on the steam generator rem) shallow-dose equivalent. The NRC removal of the generator column from tube failure at Indian Point Unit 2 was annual dose limit to the skin or any the shield using remote handling tools. completed on October 23, 2000. In this extremity is 500 mSv (50 rem) shallow- On March 31, 2000, the employee was report, the NRC evaluated the staff’s dose equivalent. The employee believed using the ad hoc procedure but the tools technical and regulatory processes that the gloves he wore provided him that were used to remove the generator related to assuring steam generator tube adequate protection from radiation. column from the shield had fallen to the integrity and identified and On April 5, 2000, Mallinckrodt bottom of the glove box and were out of recommended areas for improvement determined that the radiation monitor the employee’s reach. The employee applicable to the NRC and the industry. worn on the employee’s right hand decided on his own to remove the Subsequently, the NRC established a recorded a dose of 57 mSv (5.7 rem) column and to perform repairs without Steam Generator Action Plan detailing shallow-dose equivalent in excess of its using tools. activities to be addressed by the NRC administrative weekly limit which was Regarding the other operations that and the industry to improve 20 mSv (2 rem). Mallinckrodt’s resulted in significant doses, management of steam generator investigation of the exposure Mallinckrodt personnel believed, performance. determined that the employee had erroneously, that the doses recorded by This event is closed for the purpose directly handled the generator column the personnel monitoring devices worn of the AO report to Congress. and reported the event to the NRC on by its employees reflected the actual
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exposures received. However, the actual treatment of ocular melanomas. These Agreement State Licensees doses were, in some instances, 100 treatments were performed in an The following six events occurred at times greater than those recorded by the attempt to preserve the patients’ eyes, facilities of Agreement State licensees monitors. This was due to the distance which otherwise would have been during fiscal year 2000 and were between the monitors, which are surgically removed. The licensee’s determined to be significant enough to normally worn like a ring at the base of treatment planning system uses air- be reported as AOs to Congress. the finger, and the fingertips, where the kerma, and the supplier of the I–125 exposures were received. seeds uses millicurie units. The licensee AS 00–1 Gamma Stereotactic Radiosurgery Misadministration at Actions Taken To Prevent Recurrence made an error converting air-kerma to millicurie units. Consequently, orders Healthsouth Medical Center in Licensee—The licensee staff was were placed for a higher source strength Birmingham, Alabama instructed in the proper handling of of I–125 seeds, which were unshielded containers of radioactive Date and Place—April 12, 2000; subsequently administered to the Healthsouth Medical Center; material. The licensee increased its patients, resulting in the overdoses. radiation safety and supervisory Birmingham, Alabama. The error was identified by the oversight in the generator Nature and Probable Consequences— licensee during a review of the patients’ manufacturing laboratory. In addition, Patient A was prescribed a dose of 80 the licensee initiated and implemented charts on September 22, 2000, after the Gy (8,000 rad) to the left trigeminal managerial changes to its operations and physicist noted that the dosimetrist was nerve using a gamma stereotactic agreed to: (1) Retain an independent ordering I–125 seeds for an upcoming radiosurgery (GSR) device. However, organization to assess the radiation study with higher than expected source because of an error, a dose of about 0.2 safety program and the radiation safety strength. Gy (20 rad) was delivered to the aspects of its radioactive material The patients were informed of the intended treatment site and a dose of 80 manufacturing processes; (2) provide misadministrations. Before the start of Gy (8,000 rad) was delivered to a wrong assurance that workers have received the treatments, the patients were treatment site. training and understand procedures and informed of the substantial risk of vision On the same day that patient A was practices to maintain radiation loss, the possibility of cataract scheduled for a GSR treatment, patient exposures as low as is reasonably formation, and a 10 to 15 percent B was also admitted for a similar achievable (ALARA); (3) develop a plan possibility that removal of the eye might treatment using the same device. During to review operations for the last five be required due to tumor progression or the approval process of the treatment years to determine if additional workers eye pain. plan, the dose delivery sheet of patient have received exposures in excess of Cause or Causes—The principal cause B was inadvertently switched with that regulatory limits; and (4) request an of the misadministrations was a human of patient A. As a result, patient A was amendment to incorporate a corrective error in converting source strength of treated with the radiosurgery parameters action program into its license. NRC the I–125 seeds from air-kerma to intended for patient B, and a dose of 80 confirmed the licensee’s agreement in a millicurie units. A secondary cause was Gy (8,000 rad) was delivered at the Confirmatory Order Modifying license the failure of the authorized user and wrong treatment site within the issued on June 22, 2000. medical physicist to recheck the patient’s skull. The misadministration NRC—The NRC conducted an conversion factor equations before the was discovered immediately following Augmented Inspection Team (AIT) treatment was completed (a requirement the delivery of the dose by the patient’s inspection on May 4 through May 26, of the licensee’s Quality Management radiation oncologist. The identification 2000, and a follow up inspection on July Plan). of this misadministration prevented a 17 through August 4, 2000. As a result related misadministration for patient B. of the AIT inspection, NRC issued the Actions Taken To Prevent Recurrence The licensee notified the State agency of this misadministration on April 12, June 22, 2000, Confirmatory Order Licensee—The licensee suspended all 2000. The patient returned to the Modifying License to Mallinckrodt. On procedures involving the eye plaques Medical Center on April 20, 2000, and December 21, 2000, NRC issued a Notice until corrective actions were developed was treated as prescribed. of Violation and Proposed Imposition of and the staff was trained in the The licensee stated that the a $125,000 Civil Penalty. corrective actions. Written procedures misadministration resulted in no This event is closed for the purpose were established to ensure the accuracy observable acute effects to the patient. of the AO report to Congress. of the treatment calculations. The The patient was notified verbally within * * * * * licensee has submitted to the NRC its 24 hours by the referring physician and planned corrective actions to prevent 00–3 Brachytherapy the neurosurgeon and will be closely potential errors in the future. Misadministration at Sibley Memorial monitored by the neurosurgeon. Hospital in Washington, District of NRC—An inspection was conducted Cause or Causes—This Columbia by the NRC’s Region I office on misadministration was caused by Date and Place—September 15–20, September 28 and 29, 2000, to examine mixing patient treatment protocol 2000; Sibley Memorial Hospital; the circumstances of the documentation during approval of the Washington, District of Columbia. misadministration and the licensee’s treatment plans for the two different Nature and Probable Consequences— corrective and preventive actions. In patients that were prescribed similar Two patients were prescribed doses of accordance with the NRC’s Medical treatments. 70 Gy (7,000 rad) each for eye treatment. Event Assessment Program, the NRC has Actions Taken To Prevent Recurrence The first patient received a dose of 108.7 retained a medical consultant to assess Gy (10,870 rad) and the second patient the misadministrations and their Licensee—The licensee took received a dose of 114.70 Gy (11,470 potential consequences. Enforcement immediate action to prevent the mixing rad). action is pending. of patient treatment protocol The two patients were prescribed This event is closed for the purpose documentation. As a result, each page of iodine-125 (I–125) eye plaques for of the AO report to Congress. the treatment protocol contains a unique
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name and time stamp, which the explained the necessity of another Nature and Probable Consequences— radiation oncologist or medical treatment because of the under-dose to A patient was prescribed a gamma physicist will in the future check before a portion of the tumor site. An stereotactic radiosurgery (GSR) delivering the radiosurgery treatment. additional treatment was added to the treatment for 80 brain lesions. Each State Agency—The Alabama treatment plan to complete the brain lesion site was prescribed 12 Gy Department of Public Health, Office of prescribed dose to the intended (1,200 rad). However, a lesion site was Radiation Control was satisfied with the treatment volume of the left thalamus, treated twice because of an error. licensee’s corrective actions. The and the treatment was completed. The The patient’s treatments were based licensee’s corrective measures will be patient died as a direct result of the on computer-generated magnetic reviewed during the agency’s next metastatic condition on March 3, 1999. resonance imaging (MRI) slices taken in routine inspection of the licensee’s Cause or Causes—The the Z direction. Prior to each treatment, activities. misadministration was caused by a the lesion site coordinates were printed This event is closed for the purpose human error. One member of the out as part of the written directive and of the AO report to Congress. treatment team set a wrong coordinate they were checked manually and * * * * * and another member of the treatment initialed by the authorized user and the medical physicist. For the fourth AS 00–2 Gamma Stereotactic team failed to independently verify the coordinate setting. treatment, the licensee intended to Radiosurgery Misadministration at deliver 12 Gy (1,200 rad) to lesion site University of California in San Actions Taken To Prevent Recurrence 47. However, prior to the treatment the Francisco, California Licensee—The initial corrective wrong MRI slice was displayed in the Date and Place—September 11, 1998; actions by the licensee included computer showing lesion site 16 University of California; San Francisco, decreasing distractions to the treatment (Z=70.7 mm [2.78 in.]) instead of lesion California. The California Department of team by limiting telephone calls in the site 47 (Z= 65.0 mm [2.56 in.]). Thus, Health Services, Radiologic Health treatment control area and restricting the treatment plan was calculated at Branch was notified of the conversations in the treatment room to lesion site 16, which had already been misadministration on September 17, conversations required for the treatment treated. The written directive was 1998. The NRC staff was informed of of the patient.The licensee was prepared and signed by the authorized this event in July 2000. The State of requested by the State to contact other user and the radiation safety officer California indicated that the delay in GSR facilities to review their methods of (RSO) indicating a dose of 12 Gy (1,200 reporting this event to the NRC resulted operation. The licensee found that rad) to Z=70.7 mm (2.78 in.). The from a computer error. another GSR facility had performed a treatment was administered as indicated Nature and Probable Consequences— study comparing the frequency of in the directive. As a result, lesion site A patient was prescribed a radiation incorrect coordinate settings by 16 was treated twice. The RSO therapy treatment of two metastatic licensees who did one independent discovered the error on January 28, lesions of the brain using a gamma verification and licensees who did two. 2000, during a routine quality assurance stereotactic radiosurgery (GSR) device. The licensee used this study as a guide review of the treatment plan. The One of the brain lesions was prescribed and has adopted the procedure of licensee indicated that the retreatment a dose of 16 Gy (1,600 rad). However, performing two independent checks of of site 16 did not result in harmful because of an error, the wrong site of the the coordinate settings before each effects for the patient. The patient was brain received more than 10 Gy (1,000 rescheduled for treatment of lesion site rad). treatment and retaining the follow-up check of the coordinate settings after 47 and treatment of additional untreated The patient was treated for two sites. metastatic brain lesions, one in the left each treatment to determine if an error was made. The misadministration was reported thalamus and the other in the right to the Florida Bureau of Radiation State Agency—The findings of the parietal regions of the brain. A treatment Control, the authorized user, and the onsite investigation by the State staff plan was developed for the lesion in the patient on January 28, 2000. agreed with the findings of the left thalamus to deliver a single dose of Cause or Causes—The licensee licensee’s quality assurance review. The 16 Gy (1600 rad), at the 60% isodose determined that this misadministration State also shared the finding of the line. However, one of the seven was caused by human error. parameter settings of the GSR, the ‘‘left study performed by the licensee with Y’’ coordinate, was erroneously set at other Agreement States and with the Actions Taken To Prevent Recurrence 111 mm (4.37 in.) instead of 101 mm NRC because of the study’s generic Licensee—No action was taken by the (3.98 in.) resulting in a 5 mm (0.20 in.) implications. The State was satisfied licensee. The licensee has not identified translocation of the treatment volume. with the licensee’s corrective actions any quality management procedures This error resulted in an under-dose of and believes they should be adequate to that need to be changed to prevent this a portion of the intended treatment prevent recurrence. No enforcement type of human error. In addition, the volume and an unintended dose of more actions were taken by the State for this licensee believes that this type of error than 10 Gy (1,000 rad) to brain tissue misadministration. was detected because of its aggressive outside of the prescribed treatment This event is closed for the purpose quality assurance program. volume. The misadministration was of the AO report to Congress. State Agency—The Bureau of discovered when the licensee performed * * * * * Radiation Control performed an onsite a quality control verification of the GSR investigation on February 2, 2000. The AS 00–3 Gamma Stereotactic parameters after the radiation treatment. investigation found no apparent The licensee reported that the patient Radiosurgery Misadministration at violations of the licensee’s license or the experienced no acute side effects from Healthsouth Doctor’s Hospital in Coral regulations. During the investigation the this misadministration. The physician Gables, Florida licensee indicated that it has performed who was involved in this treatment Date and Place—January 25, 2000; in excess of 2,000 GSR procedures and notified the patient of this Healthsouth Doctor’s Hospital; Coral a quality assurance review of each misadministration. The physician Gables, Florida. procedure. Of the 2,000 procedures the
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licensee has estimated that over 600 explained that no adverse health effects and was reported to NRC on March 5, procedures involved the treatment of 20 were expected to result from this event. 1997. However, it was identified as an or more lesion sites and that this was Cause or Causes—This AO during discussions of the event at an the only time a lesion site was treated misadministration was determined to be Integrated Materials Performance twice. a sequence of human errors made by the Evaluation Program review of the State This event is closed for the purpose neurosurgeon, oncologist, and medical of Kentucky in July 2000. of the AO report to Congress. physicist during patient positioning. Nature and Probable Consequences— * * * * * However, while the root cause of the A patient was prescribed a radiation event appears to be human errors during therapy treatment using cobalt-60 AS 00–4 Gamma Stereotactic the setting of the patient positioning teletherapy equipment. The patient was Radiosurgery Misadministration at parameters, other factors may have prescribed a dose of 39 Gy (3900 rad). University of Maryland Medical contributed to the event. For example, However, the dose was administered to Systems in Baltimore, Maryland to position the patient, the treatment the wrong treatment site because of an Date and Place—April 20, 2000; team used an internal procedure which error. University of Maryland Medical was not documented in writing. This The patient was treated for bone pain Systems (UMMS); Baltimore, Maryland. procedure was not sent to the licensee’s associated with renal cell carcinoma Nature and Probable Consequences— Radiation Safety Committee or the State with metastases to the right iliac bone. A patient was prescribed a radiation Agency for approval. The radiation The prescribed treatment was 5 therapy treatment for pituitary adenoma safety officer (RSO) was a contract treatments per week for a total of 13 using a gamma stereotactic radiosurgery employee of the UMMS. Furthermore, treatments. The prescribed dose to the (GSR) device. The licensee’s therapy he had not received any specialized right iliac bone was 39 Gy (3900 rad). treatment team planned to deliver a training, e.g., equivalent to the When the patient returned for maximum dose of 18 Gy (1,800 rad) to authorized user training. Interaction evaluation of the right iliac bone pain, the 50% isodose line given in six between the RSO and the authorized the physician determined that the dose administrations. However, because of users was rare. Finally, the RSO failed of 39 Gy (3900 rad) was administered to the incorrect settings of the Y and Z to complete and document the annual the left iliac bone. coordinates, a dose of 12.5 Gy (1,250 reviews of the GSR radiation protection The licensee stated that the rad) was administered to the wrong program content and implementation misadministration had no effect on the treatment site. for the previous 3 years (1997 through patient’s life-span and did not result in The licensee’s therapy treatment team 2000). consisted of a neurosurgeon, an any permanent impairment or oncologist, and a medical physicist. The Actions Taken To Prevent Recurrence dysfunction. treatment plan was developed, Licensee—The licensee held a Cause or Causes—The causes of this reviewed, and signed by each member management conference with key misadministration were that (1) markers of the treatment team prior to the members of management, radiation were not used on the patient’s x-ray film administration of the first dose. When safety, radiation oncology, to distinguish the supine/prone the medical physicist briefly left the neurosurgery, patient care services, and positions; (2) a second x-ray film was GSR facility, the neurosurgeon and the clinical effectiveness. As a result of this incorrectly labeled as to left/right; (3) oncologist inadvertently reversed the Y meeting, the licensee implemented a the physician did not perform a visual and the Z coordinates while adjusting written protocol regarding patient inspection to determine that the correct the position of the patient’s stereotactic positioning. area had been marked on the patient; frame (moving the patient’s head to the State Agency—The onsite and (4) the prescribing physician and incorrect position). When the medical investigation by the State determined simulator therapists failed to correctly physicist returned, each member of the that the licensee failed to implement orient left/right on fluoroscopy. treatment team incorrectly verified the approved written procedures regarding Actions Taken To Prevent Recurrence position of the patient’s frame assembly. treatment planning, patient positioning, All team members signed the quality and administration of doses. Licensee—The licensee established a assurance checklist to indicate that they Furthermore, the licensee failed to requirement to label the x-ray films to conducted this check and that the complete and document the annual distinguish left/right and supine/prone patient’s frame was positioned in reviews of the GSR radiation protection positions. One of the radiation accordance with the written directive. program content and implementation physicists will review the treatment As a result, the patient’s base of the for the previous 3 years. A Department plans of patients that are not responding frontal lobe received the unintended Letter/Notice of Violation was issued on clinically as expected. The physicists dose. The medical physicist identified June 21, 2000. An enforcement action is have been retrained to check all the incorrect settings of the Y and Z pending. information in the patient’s chart coordinates while preparing to adjust This event is closed for the purpose regarding calculations and setup. The the frame assembly for the second of the AO report to Congress. physicians and therapists have been administration. Upon discovery of the * * * * * reminded of the importance of misadministration, the treatment team accurately determining patient revised the treatment plan to AS 00–5 Teletherapy orientation. accommodate for the error and to Misadministration at Western Baptist State Agency—The State agency complete the therapy procedure. The Hospital in Paducah, Kentucky reviewed the written directive and no State agency was notified of this Date and Place—October 16, 1996, to problems were noted. A telephone misadministration on April 21, 2000, November 1, 1996; Western Baptist conference was held with the radiation and performed an onsite investigation Hospital; Paducah, Kentucky. This safety officer, the attending physician, on April 26–28, 2000. misadministration was discovered by and the Director of Safety Management. The neurosurgeon notified the the hospital on January 8, 1997. The The inspection frequency for the facility patient, provided an estimate of the State was informed of the was increased. An inspection in March unintended dose delivered, and misadministration on January 8, 1997 1998 found no violations.
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This event is closed for the purpose from an external beam linear Protection, performed an onsite of the AO report to Congress. accelerator. investigation on November 21 and 22, * * * * * The fourth patient was prescribed a 2000, to review the procedures and the total dose of 79.3 Gy (7,925 rad). This findings of the licensee’s quality AS 00–6 Brachytherapy dose included brachytherapy treatments management review and to confirm that Misadministration at Aultman Hospital of 20.3 Gy (2,025 rad) and 14 Gy (1,400 the licensee’s corrective action proposal in Canton, Ohio rad) using Ir-192 sources and a dose of is adequate to prevent recurrence. Date and Place—August 22, 2000 45 Gy (4,500 rad) from an external beam Enforcement actions or penalties, if any, through October 30, 2000; Aultman linear accelerator. On October 23, 2000, will be determined at a later date. Hospital; Canton, Ohio. the patient was administered a This event is closed for the purpose Nature and Probable Consequences— brachytherapy dose of 31.5 Gy (3,150 of the AO report to Congress. As a result of a common error, four rad) Ir-192 instead of the prescribed * * * * * patients that were prescribed manual dose of 20.3 Gy (2,025 rad) Ir-192. On brachytherapy gynecological procedures November 6, 2000, the same patient was Dated at Rockville, Maryland this 25th day were administered doses higher than administered the prescribed of April, 2001. For the Nuclear Regulatory Commission. those prescribed. brachytherapy dose of 14 Gy (1,400 rad) The first patient was prescribed a total Ir-192. The patient was also Annette L. Vietti-Cook, dose of 92.9 Gy (9,290 rad). This dose administered the prescribed dose of 45 Secretary of the Commission. included brachytherapy treatments of 20 Gy (4,500 rad) from an external beam [FR Doc. 01–10821 Filed 4–30–01; 8:45 am] Gy (2,000 rad) and 22.5 Gy (2,250 rad) linear accelerator. BILLING CODE 7590–01–P using Ir-192 sources and a dose of 50.4 The misadministrations were Gy (5,040 rad) from an external beam discovered on November 3, 2000, and linear accelerator. On September 18, November 13, 2000, during an internal NUCLEAR REGULATORY 2000, the patient was administered a audit of the licensee’s Quality COMMISSION brachytherapy dose of 33.3 Gy (3,330 Management Program (QMP) by the rad) Ir-192 instead of the prescribed Radiation Safety Officer (RSO) and the Plan for Updating and Consolidating dose of 20 Gy (2,000 rad). On October Radiation Protection Staff. A telephone the Decommissioning Policy and 9, 2000, the same patient was report by the licensee’s RSO was made Guidance of the Nuclear Regulatory administered a brachytherapy dose of 35 to the Ohio Department of Health, Commission’s Office Nuclear Material Gy (3,500 rad) Ir-192 instead of the Bureau of Radiation Protection, on Safety and Safeguards, and Notice of prescribed dose of 22.5 Gy (2,250 rad) November 4, 2000, and November 13, Public Meeting Ir-192. The patient was also 2000. AGENCY: Nuclear Regulatory administered the prescribed dose of 50.4 The first, second, and fourth patients Commission. Gy (5,040 rad) from an external beam were notified of the misadministrations. ACTION: Publication of plan and notice linear accelerator. The notification of the third patient is of public meeting. The second patient was prescribed a pending because the patient was total dose of 90.7 Gy (9,070 rad). This hospitalized for an unrelated infection. SUMMARY: The Office of Nuclear dose included brachytherapy treatments The licensee stated that the clinical Material Safety and Safeguards (NMSS) of 19.8 Gy (1,980 rad) using Ir-192 treatment of these patients has not been intends to consolidate and update the sources and of 20.5 Gy (2,050 rad) using affected by the misadministrations. policy and guidance for NMSS’s a combination of Ir-192 and radium-226 Cause or Causes—The licensee decommissioning program. This (Ra-226) sources and a dose of 50.4 Gy indicated that this event was primarily endeavor is in response to the NMSS (5,040 rad) from an external beam linear caused by an operator error in the data performance goals, in the NRC’s accelerator. On August 22, 2000, the entry of the source strength in the Strategic Plan, of: (1) Making NRC patient was administered a treatment planning computer. The activities and decisions more effective, brachytherapy dose of 35.2 Gy (3,520 facility obtained a new computer in efficient, and realistic; and (2) reducing rad) Ir-192 instead of the prescribed August 2000, and the operator made a unnecessary regulatory burden on dose of 19.8 Gy (1,980 rad) Ir-192. On mistake and entered the source stakeholders. September 5, 2000, the same patient was strengths in milligram-radium- DATES: administered the prescribed dose of 20.5 equivalent instead of millicurie. Also, Comments on this plan should Gy (2,050 rad) using a combination of Ir- the quality assurance of the treatment be submitted by June 15, 2001. The 192 and Ra-226 implant sources. The planning was inadequate, and the comments will be considered by NRC in patient was also administered the second checks of treatment plans, to the process of updating and prescribed dose of 50.4 Gy (5,040 rad) which the licensee committed in its consolidating the policy and guidance from an external beam linear QMP were inadequate. for NMSS’s decommissioning program. accelerator. ADDRESSES: Submit written comments The third patient was prescribed a Actions Taken To Prevent Recurrence to: Jack D. Parrott, Project Scientist, total dose of 63.9 Gy (6,390 rad). This Licensee—As soon as the licensee’s Office of Nuclear Material Safety and dose included a brachytherapy management determined that a Safeguards, Mail Stop T–7F27, U.S. treatment of 18.9 Gy (1,890 rad) using Ir- reportable event had occurred, the Nuclear Regulatory Commission, 192 sources and a dose of 45 Gy (4,500 licensee took action to provide Washington, DC 20555–0001. Hand- rad) from an external beam linear additional training to the staff involved deliver comments to: 11555 Rockville accelerator. On October 30, 2000, the in brachytherapy procedures. The Pike, Rockville, MD, between 7:30 a.m. patient was administered a licensee submitted a written report to and 4:15 p.m., Federal workdays. Copies brachytherapy dose of 32.4 Gy (3,240 the Ohio Department of Health, Bureau of comments received may be examined rad) Ir-192 instead of the prescribed of Radiation Protection, within 15 days at the NRC Public Document Room, dose of 18.9 Gy (1,890 rad) Ir-192. The of discovering the misadministrations. 11555 Rockville Pike, Room O–1F21, patient was also administered the State Agency—The Ohio Department Rockville, MD 20852. The NRC Public prescribed dose of 45 Gy (4,500 rad) of Health, Bureau of Radiation Document Room is open from 7:45 a.m.
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